Apparatus and method for use in positioning an anchor

[0002] This application is a continuation of U.S. patent application Ser. No. 09/479,647 filed Jan. 7, 2000, now U.S. Pat. No. 6,312,448. The aforementioned application Ser. No. 09/479,647 is itself a divisional of U.S. patent application Ser. No. 09/343,371 filed Jun. 30, 1999, now U.S. Pat. No. 6,033,430. The aforementioned application Ser. No. 09/343,371 is itself a divisional of U.S. patent application Ser. No. 09/022,351 filed Feb. 11, 1998, now U.S. Pat. No. 5,948,002. The aforementioned application Ser. No. 09/022,351 is itself a continuation-in-part of U.S. patent application Ser. No. 08/752,005 filed Nov. 15, 1996, now U.S. Pat. No. 5,814,072. The benefit of the earlier filing dates of the aforementioned U.S. patent application has been and hereby is claimed.

[0003] The present invention relates to a new and improved method and apparatus for use in positioning an anchor, which may be a suture anchor, relative to the apparatus and/or relative to body tissue.

[0004] A known apparatus for use in positioning a suture anchor relative to body tissue includes a tubular member in which a suture anchor and a pusher member are received. During assembly of the apparatus it is necessary to position the suture anchor and a suture relative to the tubular member. Difficulty may be encountered in positioning the suture relative to the tubular member. In addition, difficulty may be encountered in retaining the suture anchor in a desired position relative to the tubular member.

[0005] When the known suture anchor inserter apparatus is to be utilized to position a suture relative to body tissue, a surgeon may encounter difficulty in visualizing the position of the suture anchor relative to the body tissue. In addition, difficulty may be encountered in disengaging the suture anchor inserter apparatus from the suture once the suture anchor has been positioned relative to the body tissue. Known apparatus for use in positioning a suture anchor relative to body tissue are disclosed in U.S. Pat. Nos. 5,258,016; 5,354,298; 5,403,348; and 5,464,426.

[0006] The present invention relates to a new and improved method and apparatus for use in positioning an anchor during assembly of the apparatus. The present invention also relates to a new and improved method and apparatus for use in positioning an anchor relative to body tissue.

[0007] The apparatus includes a tubular outer member and an inner member which is received in a passage in the tubular outer member.

[0008] A slot may extend between openings at opposite ends of the tubular outer member. During positioning of the anchor relative to body tissue, the slot facilitates visualization of the anchor by a surgeon. Stop surfaces may be provided in association with the inner and outer members to facilitate moving the anchor to a desired position relative to the inner and outer members during relative movement between the inner and outer members.

[0009] In addition, the apparatus may include a retainer which holds an anchor in a desired position relative to the apparatus during assembly of the apparatus and during positioning of the anchor relative to body tissue. The retainer is deflected under the influence of force applied against the retainer by the anchor to enable the retainer to grip the anchor and hold the anchor in the desired position.

[0010] The retainer may engage a recess in the anchor. The recess may be formed by a passage in the anchor. Alternatively, the recess may be formed in an outer side surface of the anchor.

[0011] During positioning of the anchor relative to body tissue, the tubular outer member may be utilized as a guide for a drill which forms an opening in the body tissue. After the opening has been formed in the body tissue, the drill is removed from the tubular outer member and the anchor is moved along the tubular outer member into the body tissue.

[0012] The foregoing and other features of the invention will become more apparent upon a consideration of the following description taken in connection with the accompanying drawings wherein:

[0013] FIG. 1 is a simplified schematic illustration of the manner in which one apparatus constructed in accordance with the present invention may be utilized to position an anchor, which may be a suture anchor, in body tissue;

[0014] FIG. 2 is an enlarged fragmentary sectional view further illustrating the relationship between the anchor, a tubular outer member and an inner member of the apparatus of FIG. 1;

[0015] FIG. 3 is a sectional view, taken generally along the line 3—3 of FIG. 2, illustrating the relationship between the tubular outer member and inner member of the apparatus;

[0016] FIG. 4 is a schematic illustration depicting the manner is in which the orientation of an anchor may be changed in the body tissue of FIG. 1;

[0017] FIG. 5 is a schematic illustration depicting the suture anchor of FIG. 4 after the anchor has been moved to a desired orientation in the body tissue;

[0018] FIG. 6 is a schematic illustration, generally similar to FIG. 1, illustrating a second embodiment of the apparatus;

[0019] FIG. 7 is an enlarged fragmentary sectional view illustrating the relationship between an anchor and a one-piece shaft of the apparatus of FIG. 6;

[0020] FIG. 8 is a sectional view, taken generally along the line 8—8 of FIG. 7 further illustrating the construction of the shaft of the apparatus;

[0021] FIG. 9 is a schematic illustration depicting the manner in which the orientation of the anchor may be changed in body tissue with the apparatus of FIGS. 6-8;

[0022] FIG. 10 is a schematic illustration depicting the relationship between an end portion of a shaft of a third embodiment of the apparatus and an anchor;

[0023] FIG. 11 is a fragmentary schematic pictorial illustration of one embodiment of another apparatus which is constructed and assembled in accordance with the present invention and is utilized to position an anchor, which may be a suture anchor, relative to body tissue;

[0024] FIG. 12 is a sectional view, taken generally along the line 12—12 of FIG. 11, illustrating the relationship between a tubular outer member and an inner member of the apparatus of FIG. 11;

[0025] FIG. 13 is a schematic illustration depicting the manner in which the apparatus of FIG. 11 is utilized to initially position an anchor relative to body tissue;

[0026] FIG. 14 is a schematic illustration, generally similar to FIG. 13, illustrating the manner in which the apparatus of FIG. 11 is utilized to move the anchor into an opening formed in the body tissue;

[0027] FIG. 15 is a schematic illustration depicting the manner in which the apparatus of FIG. 11 is utilized to change the orientation of the anchor relative to body tissue;

[0028] FIG. 16 is a fragmentary schematic pictorial illustration of a portion of an alternative embodiment of the apparatus of FIG. 11;

[0029] FIG. 17 is a sectional view, taken generally along the line 17—17 of FIG. 16, illustrating the manner in which a rotatable sleeve retains portion of a suture in a slot in a tubular outer member of the apparatus of FIG. 16, when the apparatus is used with an anchor which is a suture anchor;

[0030] FIG. 18 is a sectional view, generally similar to FIG. 16, illustrating the manner in which the sleeve is positioned relative to the tubular outer member to enable the suture to be moved out of the slot in the tubular outer member;

[0031] FIG. 19 is a fragmentary schematic illustration of an end portion of a tubular outer member of another embodiment of the apparatus illustrated in FIG. 11 and in which the end portion of the tubular outer member is contracted;

[0032] FIG. 20 is a fragmentary schematic illustration, generally similar to FIG. 19, illustrating the relationship between the end portion of the tubular outer member, an anchor, and an inner member after the end portion of the tubular outer member has been expanded and is effective to grip an outer side surface of the anchor;

[0033] FIG. 21 is a schematic sectional view depicting the manner in which a leading end of the anchor of FIG. 20 is moved into engagement with the contracted end portion of the tubular outer member of FIG. 19;

[0034] FIG. 22 is a schematic sectional view, generally similar to FIG. 21, depicting the manner in which the end portion of the tubular outer member of FIG. 19 is resiliently deflected outward by the anchor as the anchor moves to the position shown in FIG. 20;

[0035] FIG. 23 is a schematic illustration, generally similar to FIG. 22, of a another embodiment of the invention, having the same general construction as the embodiment of FIG. 11, and illustrating the manner in which a projection on the end portion of a tubular outer member engages a recess in an anchor;

[0036] FIG. 24 is a schematic sectional view, generally similar to FIGS. 21 and 22, of a projection on an end portion of a tubular outer member of an apparatus which forms another embodiment of the invention having the same general construction as the embodiment of FIG. 11;

[0037] FIG. 25 is a schematic sectional view illustrating the manner in which the projection on the end portion of the tubular outer member of FIG. 24 engages an end portion of a passage in an anchor;

[0038] FIG. 26 is a schematic sectional view, generally similar to FIG. 24, of another embodiment of the invention, having the same general construction as the embodiment of FIG. 11, and illustrating a pair of projections on an end portion of a tubular outer member;

[0039] FIG. 27 is a schematic sectional view illustrating the manner in which the projections of FIG. 26 engage the end portions of a pair of passages in an anchor;

[0040] FIG. 28 is a schematic sectional view of another embodiment of the invention, having the same general construction as the embodiment of FIG. 11, and illustrating the manner in which a spring on a tubular outer member engages an end portion of a passage in an anchor;

[0041] FIG. 29 is a schematic sectional view of another embodiment of the invention, having the same general construction as the embodiment of FIG. 1 and illustrating the manner in which a spring on an inner member engages an end portion of a passage in an anchor;

[0042] FIG. 30 is a schematic sectional view of another embodiment of the invention, having the same general construction as the embodiment of FIG. 11, and illustrating a contracted end portion of a tubular outer member as an anchor is moved toward the end portion of the tubular outer member;

[0043] FIG. 31 is a schematic pictorial illustration of a tubular outer member which forms a portion of another embodiment of the invention;

[0044] FIG. 32 is a schematic pictorial illustration of an inner member which is utilized to position an anchor relative to the tubular outer member of FIG. 31;

[0045] FIG. 33 is a schematic pictorial illustration of an inner member which is used to move an anchor out of the tubular outer member of FIG. 31;

[0046] FIG. 34 is a schematic pictorial illustration depicting the manner in which an anchor is inserted into the tubular outer member of FIG. 31;

[0047] FIG. 35 is a schematic pictorial illustration depicting the manner in which the anchor is moved along a passage in the tubular outer member of FIG. 31 by the inner member of FIG. 32;

[0048] FIG. 36 is a schematic pictorial illustration depicting the manner in which the anchor is positioned relative to the tubular outer member of FIG. 31 by the inner member of FIG. 32;

[0049] FIG. 37 is a schematic sectional view, taken generally along the line 37—37 of FIG. 36, illustrating the manner in which a projection on an outer end portion of the tubular outer member of FIG. 31 engages an outer side surface of the anchor after the anchor has been positioned by the inner member of FIG. 32;

[0050] FIG. 38 is a schematic sectional view of another embodiment of the tubular outer member illustrated in FIG. 31 and illustrating an outwardly flaring or funnel-shaped end portion on the tubular outer member;

[0051] FIG. 39 is a schematic sectional view of another embodiment of the invention and illustrating the manner in which a stop element connected with an inner member engages an end portion of a tubular outer member having a construction similar to the construction of the tubular outer member of FIG. 31;

[0052] FIG. 40 is a schematic sectional view illustrating the manner in which the stop element moves along a slot in the tubular outer member of FIG. 39 during insertion of an anchor into body tissue;

[0053] FIG. 41 is a schematic sectional view of another embodiment of the invention and illustrating the relationship between a stop element on an inner member and index recess formed in a tubular outer member having a construction similar to the construction of the tubular outer member of FIG. 31;

[0054] FIG. 42 is a schematic sectional view of another embodiment of the invention, and illustrating the manner in which a resiliently deflectable stop element on an inner member engages an end of a tubular outer member having a construction similar to the construction of the tubular outer member of FIG. 31; and

[0055] FIG. 43 is a fragmentary schematic sectional view depicting the manner in which a tubular outer member having the same general construction as the tubular outer member of the embodiment of the invention illustrated in FIG. 11, is utilized in association with a thin elongated member to guide movement of a drill relative to body tissue.

[0056] Anchor Inserter

[0057] An anchor inserter apparatus 20, constructed in accordance with the present invention, is illustrated in FIG. 1. The apparatus 20 includes a manually engageable handle 22 and a shaft 24 which extends from the handle. A leading end portion 26 (FIG. 2) of the apparatus 20 extends through a passage 28 in an anchor 30. The specific anchor 30 illustrated in FIG. 2 happens to be a suture anchor. A suture 32 engages the anchor 30. The anchor 30 could have a construction other than the illustrated construction. The anchor 30 could be constructed so as to be used without the suture 32.

[0058] The illustrated anchor 30 has a cylindrical tubular side wall 36 (FIG. 2). A trailing end portion 38 of the anchor 30 has a flat annular trailing end surface 42. In addition, the anchor 30 has a leading end portion 44. The leading end portion 44 of the anchor 30 has an annular leading end surface 46.

[0059] The tubular side wall 36 of the anchor 30 has a cylindrical outer side surface 50 which extends between the trailing end surface 42 and the leading end surface 46. In addition, the illustrated anchor 30 has a cylindrical inner side surface 52 which is disposed in a coaxial relationship with the outer side surface 50. The cylindrical inner side surface 52 forms the passage 28 which extends between the trailing end surface 42 and leading end surface 46 of the anchor 30.

[0060] A groove or slot 56 is formed in the leading end portion 44 of the anchor 30. The groove or slot 56 extends axially inward from the leading end surface 46 and extends radially between the outer and inner side surfaces 50 and 52 of the anchor 30. The slot or groove 56 has an arcuately curving inner side surface 58 across which the suture 32 extends. It is contemplated that the slot or groove 56 may be omitted if desired.

[0061] The suture 32, which is used with the specific anchor 30 illustrated in FIGS. 1 and 2, has an outer leg 62 which extends along the outer side surface 50 of the anchor. An inner leg 64 of the suture 32 extends through the passage 28 and along the inner side surface 52 of the anchor 30. The outer leg 62 and inner leg 64 of the suture 32 are interconnected by a connector section 66 of the suture. The connector section 66 of the suture 32 extends through the slot 56 in the side wall 36 of the anchor 30. If the anchor 30 is constructed without the slot 56, the connector section 66 of the suture 32 would extend across the leading end surface 46 of the anchor.

[0062] The anchor 30 is made of a biocompatible material, specifically, stainless steel. The anchor 30 has a length, that is, the distance between the trailing end surface 42 and leading end surface 46, of approximately two millimeters. The anchor 30 has an outside diameter, that is, the diameter of the outer side surface 50, of approximately one millimeter. The inner side surface 52 has a diameter of about one-half millimeter. It should be understood that the foregoing specific dimensions for one specific anchor 30 have been set forth herein only for purposes of clarity of description. It is contemplated that the anchor 30 will be constructed with dimensions which are different than the dimensions set forth above.

[0063] The illustrated anchor 30 has a cylindrical tubular side wall 36. It should be understood that the anchor 30 could have a different configuration. For example, the anchor 30 could have a polygonal cross sectional configuration if desired. Thus, the anchor 30 could have a polygonal configuration which is similar to the polygonal configuration of an anchor disclosed in U.S. Pat. No. 5,549,630 issued Sep. 27, 1996 to Peter M. Bonutti.

[0064] Although the anchor 30 is formed of metal, it is contemplated that the anchor 30 could be formed of other materials if desired. For example, the anchor 30 could be formed of body tissue. Alternatively, the anchor 30 could be formed of a polymeric material such as cellulose, petroylglutamic acid, collagen, or polylactide. It is believed that a ceramic as found in hydroxyapatite composites with polyethylene, polylactide or polyhydroxybutyrate may be utilized to form the anchor 30. If desired, the anchor 30 may be formed of a material which is hydrophilic and expands when exposed to body fluids.

[0065] The shaft 24 has a leading end portion 72 (FIGS. 1 and 2) which is used to penetrate human body tissue. The leading end portion 72 of the shaft extends through the anchor 30. The leading end portion 72 of the shaft 24 may have a point 76 which extends ahead of the leading end surface 46 of the anchor 30.

[0066] The illustrated point 76 on the inserter shaft 24 has a conical configuration with a central axis which is coincident with a central axis of the inserter shaft and anchor 30. However, if desired, the point 76 could have a wedge-shaped configuration. Similarly, the point 76 could be formed by a single flat plane which is skewed at an acute angle to a longitudinal central axis of the shaft 24. Alternatively, the leading end of the shaft 24 could have a rounded or even a flat configuration.

[0067] The leading end portion 72 of the shaft 24 extends through the passage 28 in the anchor 30. The point 76 on the leading end of the shaft 24 is disposed ahead of and is coaxial with the anchor 30. This enables the point 76 to pierce body tissue ahead of the anchor 30. Although it is believed that the provision of the point 76 on the leading end of the shaft 24 will facilitate the piercing of human body tissue, the cross sectional size of the leading end of the shaft may be so small as to enable the shaft to pierce body tissue with a blunt end.

[0068] By piercing the body tissue with the point 76, an opening is initially formed by the leading end portion 72 of the shaft 24. The shaft 24 moves the anchor into the opening which was initially formed by the point 76. The leading end surface 46 on the anchor 30 is sloped to form a continuation of a surface 80 on the point 76. The sloping leading end surface 46 on the anchor 30 promotes a smooth enlargement of the opening formed in the elastic material of the human body tissue by the point 76 on the leading end of the shaft 24. Although the point 76 is advantageously used to pierce soft body tissue, the inserter 20 may be used to position anchors 30 in preformed openings in hard body tissue, such as bone.

[0069] The shaft 24 may be used to promote movement of the anchor 30 in human body tissue in such a manner as to change the orientation of the anchor relative to the body tissue and the shaft 24. Thus, it may be desired to change the orientation of the anchor 30 relative to the shaft 24 from the orientation shown in FIG. 1 to the orientation shown in FIG. 5. However, it should be understood that the inserter 20 may also be used to position anchors 30 which remain in the orientation shown in FIG. 1 relative to the body tissue.

[0070] When the anchor 30 is used with a suture and it is desired to change the orientation of an anchor 30 relative to body tissue, a leg 62 of the suture 32 is tensioned in the manner indicated by an arrow 84 in FIG. 4. At the same time, the point 76 on the shaft 24 engages the inner side surface 52 of the passage 28 through the anchor 30. This results in the application of a torque to the anchor 30 tending to rotate the anchor in a clockwise direction (as viewed in FIG. 4) from the orientation shown in FIG. 1 through the orientation shown in FIG. 4, toward the orientation shown in FIG. 5.

[0071] As this occurs, the cylindrical outer side surface 50 of the anchor is pressed against the elastic material of human body tissue 88 and deforms the body tissue. Once the anchor has been moved to the orientation shown in FIG. 5, pulling out of the anchor from the body tissue 88 is resisted by the relatively large outer side surface 50 of the anchor. This enables the anchor to remain stable in the body tissue 88 even though relatively large forces are applied to the legs 62 and 64 of the suture 32. Although the foregoing description has related to the changing of the orientation of the anchor 30 in soft body tissue, the inserter 20 may be used to change the orientation of an anchor in cancellous bone tissue in the same manner as previously set forth in association with soft body tissue.

[0072] The foregoing description has been in conjunction with an anchor 30 which is used with a suture 32. However, the suture 32 could be omitted if desired. If this is done, the anchor 30 would be used to retain body tissue.

[0073] Inserter

[0074] The anchor inserter 20 (FIG. 1) includes a handle 22 having a configuration suitable for manual grasping by a surgeon. The illustrated handle 22 has a generally cylindrical configuration with circumferentially extending grooves to facilitate firm gripping of the handle. However, if desired, the handle 22 could be formed with a generally triangular cross sectional configuration in a manner similar to that disclosed in U.S. application Ser. No. 08/673,923 filed Jul. 1, 1996 and entitled “Suture Anchor Inserter Assembly and Method” by Peter M. Bonutti. The disclosure in the aforementioned application Ser. No. 08/673,923 is incorporated herein in its entirety by this reference thereto.

[0075] The shaft 24 extends axially outward from the handle 22. The shaft 24 has a generally cylindrical configuration and is disposed in a coaxial relationship with the handle 22. However, the shaft 24 could have a different configuration if desired. For example, if the passage 28 through the anchor 30 had a polygonal cross sectional configuration, the shaft 24 could have a corresponding polygonal cross sectional configuration.

[0076] In accordance with a feature of the embodiment of the inserter 20 illustrated in FIGS. 1-3, the shaft 24 includes a cylindrical inner member 92 and cylindrical outer member 94 which are movable relative to each other. The upper (as viewed in FIGS. 1 and 2) end of the solid cylindrical inner member 92 is fixedly connected with the handle 22. The point 76 is disposed on the lower (as viewed in FIGS. 1 and 2) end of the inner member 92. The point 76 extends ahead of the leading end portion 44 of the anchor 30 to initiate formation of an opening into which the anchor moves.

[0077] As was previously mentioned, the point 76 could be formed with a configuration other than the illustrated conical configuration. In fact, it is contemplated that the point 76 may be eliminated on some embodiments of the inserter. Although it is preferred to have the inner member 92 extend through the passage 28 and extend ahead of the leading end portion 44 of the anchor 30, the leading end of the inner member 92 could be disposed in the anchor if desired.

[0078] The outer member 94 has a tubular cylindrical configuration and partially encloses the solid inner member 92. The outer member 94 is axially movable relative to the inner member 92. The outer member 94 has a flat annular pusher surface 98 which engages the flat annular trailing end surface 42 of the anchor 30.

[0079] The inner and outer members 92 and 94 are both formed of metal, specifically stainless steel. However, the inner and outer members 92 and 94 could be formed of other materials if desired. For example, the inner member 92 could be formed of metal and the outer member 94 could be formed of a polymeric material.

[0080] The outer member 94 is axially movable along the inner member 92 between a retracted position, shown in FIGS. 1 and 2, and a fully extended position in which the pusher surface 98 is adjacent to the lower (as viewed in FIG. 2) end of the point 76. Thus, the outer member 94 is movable axially along the inner member 92 from the position shown in FIGS. 1 and 2 through the position shown in FIG. 4 to a position in which the annular pusher surface 98 is a short distance past the outer end of the point 76.

[0081] In accordance with one of the features of the present invention, a slot or groove 102 (FIG. 3) extends through a tubular cylindrical side wall of the outer member 94. The straight slot or groove 102 in the outer member 94 extends between opposite ends of the outer member 94 and is axially aligned with a passage, that is a slot, which extends through the handle 22. The two legs 62 and 64 of the suture 32 extend through the slot 102 and the passage in the handle 22 to a location disposed above (as viewed in FIG. 1) the handle.

[0082] The inner leg 64 of the suture 32 extends through the passage 28 (FIG. 2) in the anchor 30. The leading end portion of the inner member 92 also extends through the passage 28 in the anchor 30. In the illustrated embodiment of the inserter 20, a straight slot or groove 106 extends axially along the inner member 92 from the point 76 to a location which is disposed above (as viewed in FIG. 2), the pusher surface 98 when the outer member 94 is in the retracted position. The inner leg 64 of the suture then extends from the slot 106 in the inner member 92 into the slot 102 in the outer member 94. The slot 106 in the inner member 92 terminates at a location disposed axially above (as viewed in FIG. 2) the pusher surface 98 when the pusher surface is in the retracted position.

[0083] An actuator 110 is provided to move the outer member 94 axially along the inner member 92. The actuator 110 (FIG. 1) includes a manually engageable knob or input member 112 which is connected to the outer member 94 and extends through a slot 114 formed in the handle 22. The slot 114 has an axial extent which corresponds to the distance which the outer member 94 can be moved axially along the inner member 92. When the outer member 94 is in the fully retracted position of FIG. 1, the knob 112 is adjacent to an upper end of the slot 114.

[0084] After the anchor 30 has been moved into body tissue 88 and is to remain in the orientation shown in FIG. 1, the actuator knob 112 is moved downward (as viewed in FIG. 1) in the slot 114. As this occurs, force is transmitted between the pusher surface 98 and the trailing end surface 42 of the anchor 30. At the same time, the shaft 24 may be moved straight upward (as viewed in FIG. 1).

[0085] The relative movement between the anchor 30 and inner member 92 results in the trailing end surface 42 of the anchor 30 being moved in alignment with the base or upper end of the point 76. When this has happened, a cylindrical outer side or positioning surface 120 on the inner member 92 is disposed above (as viewed in FIG. 2) the annular trailing end surface 42 of the anchor 30. Continued relative movement between the inner and outer members 92 and 94 at least partially withdraws the point 76 from the passage 28 in the anchor 30. The handle 22 of the inserter 20 can then be moved or pulled upward away from the body tissue 88 and the point 76 of the shaft 24 moved completely out of the anchor 30. This results in the anchor 30 remaining in the orientation shown in FIG. 1 in the body tissue 88.

[0086] As the outer member 94 is moved axially downward (as viewed in FIGS. 1 and 2) to separate the anchor from the shaft 24, the extent of the telescopic relationship between the portions of the inner and outer members 92 and 94 disposed in the handle 22 is decreased. Thus, when the outer member 94 is in the fully retracted position shown in FIG. 1, the extent to which the portion of the inner member 92 disposed in the handle is enclosed by the outer member 94 is a maximum. As the actuator knob 112 is moved downward (as viewed in FIG. 1) in the slot 114, a portion of the outer member 94 moves out of the handle 22 and the extent of the telescopic relationship between the inner and outer members 92 and 94 in the handle 22 decreases.

[0087] The length of the slot 114 is great enough to enable the pusher surface 98 to move along the length of the point 76. When the actuator knob 112 has reached the lower end (as viewed in FIG. 1) of the slot 114, the upper end portion of the outer member 94 is still in the handle 22. At this time, the pusher surface 98 has moved to a location just past the point 76. Therefore, the point 76 is fully enclosed by the outer member 94.

[0088] It should be understood that a surgeon using the inserter 20 can determine the extent of relative movement between the inner and outer members 92 and 94. The surgeon may move the actuator knob 112 through only a portion of the length of the slot 114. Suitable indicia may be provided along the slot 114 to indicate the position of the pusher surface 98 relative to the point 76.

[0089] In the embodiment of the invention illustrated in FIG. 1, the actuator knob 112 is connected directly with the outer member 94 and is movable in the slot 114 in the handle 22. However, it is contemplated that the actuator knob 112 and the slot 114 could be eliminated and suitable knurling and/or projections provided on the outer member 94. The knurling or projections on the outer member 94 may be manually engaged and force transmitted directly from the hand of a surgeon to the outer member. If force is to be manually applied directly to the outer member 94, the outer member could either extend into the handle 22 or terminate short of the handle.

[0090] Insertion of Anchor

[0091] When the anchor 30 is to be inserted into body tissue 88, the optional suture 32 extends through the passage 28 in the anchor 30. The legs 62 and 64 of the suture 32 extend along the slot 102 in the outer member 94 and through the passage (not shown) in the handle 22. However, if desired, the legs 62 and 64 of the suture 32 could extend along the outside of the shaft 24 and handle 22. If desired, the suture 32 could be omitted.

[0092] The anchor 30 is then positioned on the leading end portion 26 of the inserter 20. Since the specific anchor 30 illustrated in the drawings is a suture anchor, the suture 32 extends through the passage 28 in the anchor and with the outer member 94 in the retracted position of FIGS. 1 and 2. It should be understood that the suture 32 could be connected with the anchor 30 in a manner other than by extending through the passage 28. For example, an opening could be provided in the anchor 30 at a location spaced from the passage 28. The suture 32 could extend through or be tied off at this opening.

[0093] To position the anchor 30 on the leading end portion 26 of the shaft 24, the point 76 on the inner member 92 is inserted into the passage 28 in the anchor 30. The slot 106 in the inner member 92 is aligned with the inner leg 64 of the suture. The anchor is then moved along the inner member 92 until the trailing end surface 42 on the anchor moves into abutting engagement with the pusher surface 98 on the outer member 94. At this time, the point 76 on the inner member 92 extends outward from and is coaxial with the end surface 46 of the anchor 30. The suture 32 is then tensioned to hold the anchor 30 in place.

[0094] The point 76 on the inner member 92 is then moved into engagement with an imperforate outer surface 130 (FIG. 1) on a human patient's skin 132. Manual force is applied to the handle 22 to cause the point 76 on the inner member 92 to pierce the surface 130. As this occurs, a circular opening is formed in the skin 132 by the point 76 of the inner member 92. This opening is formed directly ahead of and in axial alignment with the anchor 30.

[0095] The manual application of downward (as viewed in FIG. 1) force against the handle 122 moves the point 76 of the inner member 92 through the skin 132 into flesh 134 disposed beneath the skin. As this occurs, the leading end portion 44 of the anchor 30 moves into the opening which was initially formed by the point 76 on the inner member 92. The annular pusher surface 98 on the outer member 94 presses against the annular trailing end surface 42 of the anchor 30 to push the anchor into the body tissue.

[0096] Movement of the leading end portion 44 of the anchor 30 into the opening formed by the point 76 in the body tissue is facilitated by having at least a portion of the leading end surface 46 of the anchor 30 slope radially outward as a continuation of the surface 80 on the point 76. As the leading end 44 of the anchor 30 is pressed against the viscoelastic body tissue 88, the initial opening is elastically expanded and the anchor 30 moves into the flesh 134 disposed beneath the skin 132. The point 76 pierces the flesh 134 ahead of the anchor 30 to initiate the formation of an opening in the flesh for the anchor.

[0097] Continued application of force to the handle 22 results in the shaft 24 moving the anchor 30 to a desired depth in the body tissue 88. As this occurs, the point 76 on the inner member 92 continues to penetrate or pierce the body tissue 88 ahead of the anchor 30. This facilitates movement of the shaft 24 and anchor 30 into the body tissue 88.

[0098] The anchor 30 is moved into the body tissue 88 under the influence of force transmitted from the pusher surface 98 on the outer member 94 to the trailing end surface 42 of the anchor. Thus, as the shaft 24 and anchor 30 move into the body tissue 88, the outer member 94 is stationary relative to the inner member 92. The pusher surface 98 on the outer member 94 presses against the trailing end portion 38 of the anchor 30 with a force sufficient to move the anchor into the body tissue 88.

[0099] Once the anchor 30 has been moved into the body tissue 88, the anchor and shaft 24 are separated. When this is to be done, any tension in the legs 62 and 64 of the suture is eliminated. The actuator knob 112 is then moved downward (as viewed in FIG. 1) along the slot 114. As this occurs, relative movement between the anchor 30 and the inner member 92 results in the point 76 (FIG. 2) on the inner member being circumscribed by the tubular side wall 36 of the anchor.

[0100] When the anchor 30 is being separated from the inserter 20, the anchor may be pushed off of the end of the inner member 92 by the outer member 94 while the inner member remains stationary relative to the body tissue. Alternatively, the handle 22 and inner member 92 may be moved upwardly and the anchor 30 and outer member 94 maintained stationary relative to the body tissue. It is contemplated that, in all probability, there will be a combined movement of the anchor 30 and outer member 94 axially along the inner member 92 and withdrawal of the inner member from the body tissue as the anchor is separated from the shaft 24.

[0101] Changing Anchor Orientation

[0102] As the anchor 30 is separated from the shaft 24, it may remain in the orientation shown in FIG. 1 relative to the body tissue 88 and the shaft. Alternatively, the anchor 30 may be moved through the orientation shown in FIG. 4 to the orientation shown in FIG. 5. At least a portion of this movement of the anchor 30 occurs while the leading end portion 26 of the inserter 20 is in the passage 28 in the anchor.

[0103] During movement of the anchor 30 to a desired depth in the body tissue 88 (FIG. 1), the outer side surface 120 on the inner member 92 positions the anchor in a coaxial relationship with the inner member 92 and retains the anchor against pivotal movement. When the anchor 30 has been moved to the desired depth in the body tissue 88, the actuator 110 is manually operated. This causes relative movement between the inner and outer members 92 and 94.

[0104] As relative movement occurs between the inner and outer members 92 and 94, the point 76 on the outer member and the pusher surface 98 on the inner member move toward each other (FIG. 4). As this occurs, the positioning surface 120 on the inner member 92 almost moves out of the passage 28 in the anchor 30 (FIG. 4). This releases the anchor 30 for pivotal movement relative to the shaft 24. Although a major portion of the positioning surface 120 has been withdrawn from the anchor passage 28, the point 76 on the inner member 92 and the outermost portion of the positioning surface 120 are disposed in the passage 28 in the anchor.

[0105] Pivotal movement of the anchor 30 is then initiated by tensioning the outer leg 62 of the suture 32, as indicated by the arrow 84 in FIG. 4. The tension force applied to the leading end portion 44 of the anchor 30 causes it to rotate in a clockwise direction toward the position shown in FIG. 4. As the anchor approaches the position shown in FIG. 4, the inner side surface 52 on the anchor 30 moves into engagement with the outer side surface 80 on the point 76. This results in the transmittal of force from the outer side surface 80 of the point 76 to the inner side surface 52 of the anchor 30 in a downward (as viewed in FIG. 4) direction to further promote pivotal movement of the anchor in a clockwise direction.

[0106] As the outer member 94 continues to push downward (as viewed in FIG. 4) against the trailing end surface 42 of the anchor 30, the anchor continues to pivot relative to the shaft 24. The anchor 30 pivots about a location where the trailing end surface 42 of the anchor engages the outer member 94. In addition, the anchor 30 pivots about a location where the point 76 engages the inner side surface 52 of the anchor. This combined pivotal movement is caused by the tension in the outer leg 62 of the suture 32.

[0107] As the pusher surface 98 approaches and then moves past the base of the point 76, the point moves out of the passage 28 through the anchor 30. The anchor 30 then continues to pivot in a clockwise direction under the influence of the force applied to the anchor by the tension in the outer leg 62 of the suture 32. This force causes the anchor to move to the position shown in FIG. 5, or at least to a position closely approximating the position shown in FIG. 5. Once the anchor 30 has moved to the position shown in FIG. 5 relative to the body tissue 88, the relatively large outer side surface 50 of the anchor resists pulling out of the anchor from the body tissue. Therefore, relatively large forces can be transmitted through the suture 32 to the anchor 30 without pulling the anchor out of the body tissue.

[0108] When the anchor 30 is to be inserted into bone with the inserter 20, an opening is drilled through the hard outer layer of the bone into the soft inner material of the bone. Once this has been done, the inserter 20 is used to position the anchor 30 in the spongy cancellous tissue within the bone. The orientation of the anchor 30 may be changed, relative to the bone, in the same manner as previously explained herein.

[0109] It should be understood that it is contemplated that the inserter 20 may be used to position an anchor 30 in either hard or soft tissue at many different locations in a patient's body. The pointed end 76 of the inserter 20 may be used to pierce body tissue at locations remote from the patient's skin 132 (FIG. 1). Thus, the inserter 20 may be used to position an anchor in an organ disposed within the patient's body.

[0110] When the inserter 20 is to be used to position the anchor 30 in a preformed opening in hard body tissue, such as the hard outer or cortical layer of bone, the inner member 92 may not extend past the leading end portion 44 of the anchor 30. When the inserter 20 is to be used to position the anchor 30 in soft body tissue, the formation of an opening in the body tissue for the anchor 30 may be accomplished without piercing the body tissue with the inner member 92 and the inner member may not extend past the anchor. However, it is believed that it may be preferred to have the point 76 extend ahead of the anchor 30 even when the point is not to be used to pierce body tissue.

[0111] Inserter—Second Embodiment

[0112] In the embodiment of the inserter or apparatus illustrated in FIGS. 1-5, the shaft 24 is formed by two members, that is, the inner member 92 and the outer member 94. In the embodiment of the inserter illustrated in FIGS. 6-9, the shaft of the inserter is formed by a single member. Since the embodiment of the invention illustrated in FIGS. 6-9 is generally similar to the embodiment of the invention illustrated in FIGS. 1-5, similar numerals will be utilized to designate similar components, the suffix letter “a” being associated with the numerals of FIGS. 6-9 to avoid confusion.

[0113] An anchor inserter 20a(FIG. 6) includes a manually engageable handle 22aand a one piece shaft 24awhich extends outward from the handle. A leading end portion 26aof the one piece shaft 24aextends through a passage 28ain the anchor 30a. Since the illustrated anchor 30ais a suture anchor, a suture 32aextends through the passage 28ain the anchor and along the shaft 24a. The suture 32aextends through a passage (not shown) in the handle 22a. The anchor 30ahas the same construction as the anchor 30 in the embodiment of the invention illustrated in FIGS. 1-5. However, the anchor 30acould have a different construction if desired. The anchor 30acould be used without the suture 32aif desired.

[0114] The shaft 24aof the inserter 20ais formed as one piece. Thus, the shaft 24aincludes a main section 142 (FIGS. 6 and 7) and a leading end section 144 (FIG. 7). The leading end section 144 includes a cylindrical positioning portion 146 which is disposed in a coaxial relationship with the cylindrical main section 142. A generally conical point 76ais formed on the leading end section 144 and has a conical outer side surface 80a.

[0115] A pusher surface 98aforms a flat annular shoulder where the cylindrical main section 142 is connected with the leading end section 144 of the shaft 24a. Since the shaft 24ais formed from a single piece of material, that is, stainless steel, the pusher surface 98adoes not move relative to the point 76aof the shaft 24a. Although it is preferred to form the shaft 24afrom a single piece of metal, the shaft may be formed by a solid cylindrical inner member and a cylindrical tubular outer member which is fixedly connected to the inner member. When the shaft 24ais formed by two fixedly connected members, the members may be different materials.

[0116] A slot 102a(FIGS. 7 and 8) extends from the base of the point 76aalong the shaft 24a. The slot 102aextends through the handle 22a. The depth of the slot 102ais greater in the main section 142 (FIG. 7) of the one piece shaft 24athan in the leading end section 144 of the shaft. The inner and outer legs 62aand 64aof the suture 32aare received in the slot 102a(FIG. 8) when he inserter 20ais used to position a suture anchor relative to body tissue.

[0117] When the anchor 30ais to be inserted into human body tissue 88a(FIG. 6), the anchor is first positioned on the leading end section 144 of the shaft 24awith the suture 32aextending through the passage 28ain the anchor 30a. Thus, the anchor 30ais telescopically moved onto the positioning portion 146 of the leading end section 144 of the shaft 24a. As this occurs, a trailing end surface 42aon the anchor 30ais positioned in abutting engagement with the annular pusher surface 98a.

[0118] A cylindrical outer side surface 120aon the positioning portion 146 engages a cylindrical inner side surface 52aof the anchor 30a(FIG. 7). The positioning surface 120aon the leading end section 144 of the shaft 24apositions the anchor 30ain a coaxial relationship with the shaft 24aand the point 76a. When the anchor 30ais a suture anchor, the two legs 62aand 64aof the suture 32aare tensioned to hold the trailing end surface 42aof the anchor 30ain abutting engagement with the pusher surface 98aon the shaft 24a.

[0119] The point 76aon the leading end section 144 of the shaft 24ais then moved into engagement with an imperforate outer surface 130a(FIG. 6) of a human patient's skin 132a. A downward force is then manually applied to the handle 22a. This force causes the point 76aon the shaft 24ato pierce the outer side surface 130aof the skin 132a. The point 76athen moves into flesh 134adisposed beneath the skin. As this occurs, an opening is formed by the point 76ain the skin 132a.

[0120] The anchor 30amoves into the opening in the skin 132a. Force is applied against the trailing end surface 42aof the anchor 30aby the pusher surface 98ato push the anchor into the body tissue 88a. A leading end surface 46aon the anchor 30ais sloped so as to form a continuation of the outer side surface 80aof the point 76a. This results in a smooth enlargement or stretching of the circular opening which is initially formed in the skin 132aby the point 76aof the shaft 24a. As the shaft 24aand anchor 30acontinue to move downward (as viewed in FIG. 6) into the flesh 134abeneath the skin 132a, the point 76aon the shaft 24apierces the body tissue to facilitate movement of the anchor 30ainto the body tissue.

[0121] Once the anchor 30ahas been moved to the desired depth in the body tissue, the anchor is separated from the shaft 24a. This may be done by merely withdrawing the leading end section 144 of the shaft 24afrom the anchor 30awhile the anchor remains in the orientation shown in FIG. 6 in the body tissue 88a. It is contemplated that there will be relatively little friction between the outer side surface 120aon the positioning portion 146 of the shaft 24aand the inner side surface 52a. This enables the anchor to be held in position in the body tissue 88aby the resilient force applied against the anchor 30aby the body tissue as the inserter 20ais withdrawn from the anchor.

[0122] It is contemplated that it may be desired to apply force against the trailing end surface 42aof the anchor 30ato facilitate separation of the shaft 24afrom the anchor 30a. If this is the case, a cylindrical pusher rod 150 (FIG. 7) may be provided in a suitable passage formed in the solid shaft 24a. An actuator 110ahas a knob 112awhich is connected with the pusher rod 150 and is movable along a slot 114aformed in the handle 22a.

[0123] When the shaft 24ais to be withdrawn from the anchor 30a, the actuator knob 112ais moved downward. This results in the pusher rod 150 moving downward (as viewed in FIG. 7) relative to the shaft 24a. A circular leading end surface on the pusher rod 150 applies force against the trailing end surface 42aof the anchor to facilitate separation of the shaft from the anchor. It should be understood that the pusher rod 150 is optional and may be omitted if desired.

[0124] It is believed that in certain situations at least, it will be desired to change the orientation of the anchor relative to the body tissue 88aand the shaft 24aas the shaft 24aand anchor 30aare separated. To accomplish this, the leg 62aof the suture 32ais tensioned, in the manner indicated by the arrow 84ain FIG. 9 as the shaft 24ais withdrawn from the anchor. This results in pivoting movement of the anchor relative to the shaft 24ain the same manner as previously explained in conjunction with the embodiment of the invention illustrated in FIGS. 1-5.

[0125] It is believed that the use of the pusher rod 150 to apply force against a side of the anchor 30aopposite from the suture 32awill promote pivoting movement of the anchor. In addition, pivoting movement of the anchor 30ais promoted by engagement of the outer side surface 80aon the point 76aof the shaft 24awith the inner side surface 52aof the anchor. It should be understood that the anchor 30amoves through the orientation shown in FIG. 9 to the orientation shown in FIG. 5 for the anchor 30.

[0126] It is contemplated that the point 76amay have a configuration which is different than the illustrated conical configuration. For example, the point 76acould be formed by a single flat side surface which is skewed relative to a central axis of the shaft 24 or by a plurality of skewed flat side surfaces which intersect at the central axis of the shaft. Alternatively, the end of the end section could have a blunt or flat configuration rather than the illustrated pointed configuration.

[0127] Third Embodiment of Inserter

[0128] In the embodiments of the inserter illustrated in FIGS. 1-9, the anchor is retained on the shaft of the inserter prior to insertion of the anchor into body tissue. In the embodiment of the invention illustrated in FIG. 10, the inserter includes a spring which is utilized to retain the anchor on the shaft of the inserter. Since the embodiment of the invention illustrated in FIG. 10 is generally similar to the embodiments of the invention illustrated in FIGS. 1-9, similar numerals will be utilized to designate similar components, the suffix letter “b” being associated with the numerals of FIG. 10 to avoid confusion.

[0129] An inserter 20b(FIG. 10) includes a handle (not shown) and a shaft 24bwhich extends outward from the handle. The shaft 24bis integrally formed from a single piece of metal, that is, stainless steel. The shaft 24bincludes a relatively large diameter main section 142band a relatively small diameter leading end section 144b. The leading end section 144bincludes a positioning portion 146bon which a conical point 76bis disposed in a coaxial relationship with the main section 142bof the shaft 24b. An annular pusher surface 98bis formed at the junction between the main section 142band positioning portion 146bof the shaft 24b.

[0130] In the illustrated embodiment of an anchor 32bthe anchor is a suture anchor. A suture 32bhas an outer leg 62bwhich extends along the outside of the anchor 30b. In addition, the suture 32bhas an inner leg 64bwhich extends through a passage 28bin the anchor 30b. The leading end section 144band the inner leg 62bof the suture 32bboth extend through the passage 28bin the anchor 30b.

[0131] In accordance with a feature of this embodiment of the invention, a spring 160 extends through a passage in the shaft 24b. The illustrated spring 160 is formed of metal wire. However, the spring 160 could be a leaf spring formed of sheet metal if desired.

[0132] An upper end portion (not shown) of the wire spring 160 is connected with an actuator knob, corresponding to the actuator knobs 112 and 112aof the embodiments of the invention illustrated in FIGS. 1-9. The spring 160 has a bent portion 164 which engages an inner side surface 52bof the anchor 30b.

[0133] After the anchor 30bhas been inserted into body tissue, in the manner described in conjunction with the embodiment of the invention illustrated in FIGS. 1-9, the spring 160 is axially tensioned. To axially tension the spring 160, the actuator knob is moved away from the leading end section 144bof the shaft 24b. The axial tension causes the bent portion 164 of the spring 160 to straighten and move out of engagement with the inner side surface 52bof the passage 28bin the anchor 30b. The shaft 24bcan then be withdrawn from the anchor 30b.

[0134] It is preferred to move the bent portion 164 of the spring 160 out of engagement with the inner side surface 52bof the anchor 30bby resiliently flexing the spring. However, the tension force applied to the spring 160 may only effect a reduction in the force applied by the spring against the inner side surface 52bof the anchor 30b.

[0135] In the embodiment of the invention illustrated in FIG. 10, the anchor 30band one-piece shaft 24bare separated by merely withdrawing the shaft from the anchor after it has been positioned in a desired location in body tissue. However, a pusher member, corresponding to the pusher rod 150 of the embodiment of the invention illustrated in FIGS. 6-9 could be utilized to promote separation of the anchor 30bfrom the shaft 24bif desired. Alternatively, the shaft 24bcould be formed by two relatively movable members, corresponding to the inner and outer members 92 and 94 of the embodiment of the invention illustrated in FIGS. 1-5. Of course, the orientation of the anchor 30bcan be changed relative to the shaft 24bby tensioning the leg 64bof the suture 32bas the point 76bof the shaft 24bmoves to a location adjacent to the trailing end surface 42bof the anchor.

[0136] Inserter—Fourth Embodiment

[0137] In the embodiments of the invention illustrated in FIGS. 1-10, the outer member 94 moves relative to the inner member 92 during positioning of an anchor relative to body tissue. In the embodiment of the invention illustrated in FIGS. 11-15, the inner member may move relative to the outer member. Since the embodiment of the invention illustrated in FIGS. 11-15 is generally similar to the embodiments of the invention illustrated in FIGS. 1-10, similar numerals will be utilized to identify similar components, the suffix letter “c” being added to the numerals of FIGS. 11-15 to avoid confusion.

[0138] An anchor inserter apparatus 20c, constructed in accordance with the present invention, is illustrated in FIG. 11 and is used to position an anchor 30crelative to body tissue. The illustrated anchor 30ais a suture anchor. The apparatus 20cincludes a tubular outer member 94c. The tubular outer member 94chas a cylindrical tubular body 200 and a handle 22cwhich are integrally formed as one piece.

[0139] An inner member 92cis disposed in a passage 204 which is formed in the tubular outer member 94c. The cylindrical passage 204 extends between a circular entrance opening 206 and a circular exit opening 208 formed in the tubular outer member 94c. The inner member 92cincludes a cylindrical body 212. A circular handle 214 is integrally formed as one piece with the cylindrical body 212 of the inner member 92c. The inner member 92chas an axially tapered leading end portion 218 with a surface which applies force against a trailing end portion 48cof the suture anchor 30c.

[0140] The apparatus 20cis illustrated in FIG. 11 in a fully assembled condition prior to use of the apparatus to position the anchor 30cin either hard or soft body tissue. At this time, the trailing end portion 38cof the suture anchor 30cis disposed in the passage 204 in the tubular outer member 94c. A leading end portion 44cof the suture anchor 30cextends outward from the tubular member 94c.

[0141] In accordance with a feature of this embodiment of the invention, a slot 102c(FIGS. 11 and 12) extends between the entrance opening 206 (FIG. 11) to the cylindrical passage 204 and the exit opening 208 from the passage. The slot 102cextends through the handle 22c. The slot 102cis defined by a pair of flat parallel linear side surfaces 224 and 226 (FIGS. 11 and 12). The side surfaces 224 and 226 extend between a cylindrical outer side surface 228 (FIG. 12) on the tubular outer member 94cand a cylindrical inner side surface 230 (FIG. 12) of the passage 204 in the tubular outer member.

[0142] When the inserter 20cis used with a suture anchor, the slot 102cfacilitates positioning of the anchor 30cin the passage 204 during assembly of the suture anchor inserter apparatus 20c(FIG. 11). This is because outer and inner legs 62cand 64cof the suture 32ccan be readily positioned in the slot 102cduring assembly of the anchor inserter apparatus 20c. The slot 102chas a straight longitudinal central axis which extends parallel to the longitudinal central axis of the passage 204 and to a longitudinal central axis of the cylindrical body 212 of the inner member 92c. The legs 62cand 64cof the suture 32cextend between axially opposite ends of the slot 102c. The slot 102cencloses the suture 32cand protects the legs 62cand 64cagainst being snagged by objects in the environment around the suture anchor inserter apparatus 20c.

[0143] When the anchor inserter apparatus 20cis to be assembled and used with a suture anchor, the suture 32c(FIG. 11) is inserted through a pair of passages 236 and 238 in the suture anchor 30c. The passages 236 and 238 extend diametrically through the suture anchor 30cwhich, 7) except for the passages 236 and 238, is a solid piece of material. A connector section 66c(FIG. 13) of the suture extends between the passages 236 and 238. Although the illustrated anchor 30cis formed from a solid cylindrical piece of stainless steel, the anchor 30ccould be formed of any one of many different materials and have any one of many different configurations, in the manner previously explained in conjunction with the embodiment of the invention illustrated in FIGS. 1-5.

[0144] Once the suture 32c(FIG. 11) has been threaded through the passages 236 and 238 in the suture anchor 30c, the suture anchor is moved through the entrance opening 206 into the passage 204. The cylindrical body 212 of the inner member 92cis then moved through the entrance opening 206 into the passage 204. The leading end portion 218 of the inner member 92cmoves into engagement with the trailing end portion 38cof the anchor 30c. The inner member 92cis then used to push the anchor 30calong the passage 204. Of course, if the anchor 30cis not utilized to anchor the suture 32c, the suture would be omitted.

[0145] In the illustrated embodiment of the invention, the tubular outer member 94cis constructed with a passage 204 having an inside diameter which is less than the outside diameter of the anchor 30c. This results in interference or drag between the anchor 30cand the inner side surface 230 of the passage 204 in the tubular outer member 94c.

[0146] The slot 102c(FIG. 11) in the tubular outer member 94cfacilitates resilient flexing of the tubular outer member under the influence of force applied against the inner side surface 230 of the passage 204 by the anchor 30c. The cylindrical body 212 of the inner member 92chas an outside diameter which is less than the inside diameter of the passage 204. Therefore, there is no interference between the inner member 92cand the outer member 94cas the inner member 92cis inserted into the passage 204. Of course, interference could be provided between the outer side surface on the body 212 of the inner member 92cand the inner side surface 230 of the passage 204 if desired.

[0147] As the anchor 30cmoves along the passage 204 under the influence of force applied against the anchor by the inner member 92c, the outer member 94cis resiliently flexed and the width of the slot 102cincreases to accommodate the interference between the anchor 30cand the inner side surface 230 of the passage 204. It should be understood that there is only a small amount interference between the anchor 30cand the inner side surface 230 of the passage 204 in the tubular outer member so that the inner member 92ccan, with a relatively moderate amount of force, move the anchor 30calong the passage 204.

[0148] The anchor 30cis moved along the passage 204 to a position in which the trailing end portion of the anchor 30cis disposed in the passage and the leading end portion 44cof the suture anchor extends outward from the tubular outer member 94c(FIG. 11). When the anchor 30cmoves to this position, the application of force to the inner member 92cis interrupted. The interference between the outer side surface of the anchor 30cand the inner side surface 230 of the passage 204 results in the tubular outer member 94cgripping the outer side surface of the suture anchor 30c. This gripping action enables the tubular outer member 94cto hold the anchor 30cagainst movement relative to the tubular outer member. This results in the anchor 30cbeing maintained in the position shown in FIG. 11 during handling of the anchor inserter apparatus 20c.

[0149] Once the anchor 30chas been moved to the position shown in FIG. 11, the outer and inner legs 62cand 64cof the suture 32care moved into the slot 102cand tensioned. The taut suture legs 62cand 64care straight and have longitudinal central axes extending parallel to the longitudinal central axis of the slot 102cand the passage 204 in the tubular outer member 94c. The legs 62cand 64cof the suture 32cextend through opposite ends of the slot 102c. The suture legs 62cand 64cextend through the portion of the slot 102cdisposed in the handle 22c. A suitable retainer, such as adhesive tape, may be utilized to secure the legs 62cand 64cto the cylindrical body 312 of the inner member 92cand to retain the suture legs 62cand 64cin the slot 102c. The resiliently deflected body 200 of the tubular outer member 94cpresses the cylindrical inner side surface 230 of the tubular outer member against the cylindrical outer side surface 50cof the trailing end portion 38cof the anchor 30cto hold the anchor in place.

[0150] After the apparatus 20chas been assembled, in the manner previously explained, the apparatus is transported from a remote assembly location to an operating room or other location where the apparatus is to be used to position the anchor 30cin body tissue. The manner in which the suture anchor inserter apparatus 20cis used to position the anchor 30cin a recess or opening 250 formed in bone 252 is illustrated schematically in FIGS. 13-15. The bone 252 includes a hard outer layer 254 and soft cancellous inner bone 256.

[0151] When the anchor 30cis to be positioned in the bone 252, the leading end portion 44c(FIG. 11) of the anchor 30cis inserted into the recess or opening 250. Since the leading end portion 44cof the anchor 30cextends outward from the tubular outer member 94c, aligning of the anchor 30cwith the opening 254 in the bone 252 is facilitated. In addition, the presence of the slot 102cenables a surgeon to visualize the position of the leading end portion 44cof the anchor 30crelative to the outer layer 254 of the bone 252 as the leading end portion 44cof the anchor 30cis inserted into the recess or opening 250 (FIGS. 11 and 13). During initial positioning of the anchor 30cin the opening 250 in the bone 252, the tubular outer member 94cgrips the anchor and holds the anchor against movement relative to the tubular outer member.

[0152] Once the leading end portion 44cof the anchor 30chas been positioned in the opening 250, in the manner illustrated schematically in FIG. 13, the tubular outer member 94cand inner member 92care moved relative to each other to move the anchor 30cfurther into the opening 250. Thus, the inner member 92cis moved downward (as viewed in FIG. 13) to push the trailing end portion 38c(FIG. 11) of the anchor 30cout of the passage 204 in the tubular outer member 94c. As this occurs, the leading end portion 218 of the inner member 92cmoves out of the tubular outer member 94cinto the opening 250 (FIGS. 13 and 14).

[0153] When the anchor 30cis a suture anchor, the legs 62cand 64cof the suture 32care tensioned to pivot or toggle the anchor relative to the leading end portion 218 of the inner member 92c. This results in the anchor 30cmoving from an orientation in which a longitudinal central axis of the anchor 30cis aligned with the longitudinal central axis of the tubular outer member 94c(FIG. 13) to a position in which the longitudinal central axis of the anchor 30cextends transverse to the longitudinal central axis of the tubular outer member 94c. The leading end portion 318 of the inner member 92cis tapered to promote the pivotal movement of the anchor 30cin a manner similar to that disclosed in U.S. Pat. No. 5,403,348 issued Apr. 4, 1995 to Peter M. Bonutti and entitled “Suture Anchor”. However, as was previously mentioned, the anchor 30ccould remain in its initial orientation.

[0154] Once the anchor 30chas been pivoted to the desired orientation relative to the bone 252, the inserter apparatus 20cis withdrawn from the recess 250 and disengaged from the legs 62cand 64cof the suture 32c. Disengagement of the anchor inserter apparatus 20cfrom the suture 32cis facilitated by the slot 102c(FIG. 11) in the tubular outer member 94c. Thus, when the anchor inserter apparatus 20cis to be disengaged from the suture 32c, it is merely necessary move the anchor inserter apparatus 20csidewardly away from the legs 62cand 64cof the suture 32cor to pull the legs of the suture sidewardly away from the anchor inserter apparatus 20c.

[0155] Once the tubular outer member 94cand inner member 92chave been disengaged from the suture 32c, the anchor inserter apparatus 20 is sterilized. A suture anchor 30cis then loaded into the anchor inserter apparatus 20cand suture anchor inserter apparatus reused. The slot 102cfacilitates reloading of the anchor inserter apparatus 20c.

[0156] Although the anchor inserter apparatus 20cmay be initially loaded or reloaded with a second anchor 30cmin the manner previously explained, it is believed that it may be preferred to load the anchor inserter apparatus 20cby merely moving the trailing end portion 38cof anchor 30cthrough the exit opening 208 in the leading end portion 242 of the tubular outer member 94cwhile the tubular inner member 92cis withdrawn. The trailing end portion 38cof the anchor 30ccan be manually inserted through the opening 208 in the leading end portion 242 of the tubular outer member 94c. The trailing end portion 38cof the anchor 30cis rounded or chamfered to facilitate moving the trailing end portion 38cof the anchor 30cinto the passage 204 in the tubular outer member 94c.

[0157] As an anchor 30cis manually moved into the leading end portion 242 of the tubular outer member 94c, the trailing end portion 38cof the anchor 30capplies force against the exit opening 208 to resiliently deflect and expand the body 200 of the tubular outer member 94c. As the body 200 of the tubular outer member 94cis resiliently expanded, the width of the portion of the slot disposed in the leading end portion 242 of the tubular outer member 94cis increased. This results in the inner side surface 230 of the passage 204 in the tubular outer member 94cfirmly gripping the trailing end portion 38cof the anchor 30cas the anchor is moved through the opening 208.

[0158] The tubular outer member 94cand inner member 92cmay be formed of any desired material. For example, it is contemplated that the tubular outer member 94cand handle 22ccould be fabricated from a single piece of metal sheet material. The inner member 92cand handle 214 could be fabricated from a metal rod. Alternatively, the tubular outer member 94cand handle 22ccould be integrally molded as one piece of polymeric material.

[0159] Similarly, the inner member 92cand handle 214 could be molded of a suitable polymeric material.

[0160] In the foregoing description of the manner in which the anchor 30cis positioned relative to the bone 252, the anchor is moved out of the passage 204 in the tubular outer member 94cby moving the inner member 92crelative to the outer member 94c. However, it is contemplated that the anchor 30ccould be separated from the tubular outer member 94cby moving the tubular outer member relative to the inner member 92c. Thus, the inner member 92ccould be maintained stationary and the outer member 94cmoved relative to the inner member. Although FIGS. 13-15 is illustrate positioning the anchor 30crelative to the bone 252, the anchor inserter apparatus 20ccould be used to position the anchor relative to soft body tissue.

[0161] In the embodiment of the invention illustrated in FIG. 11, the tubular outer member 94chas a relatively simple flange-type handle 22cand the inner member 92chas a relatively simple handle 214. It is contemplated that the tubular outer member 94cand the inner member 92ccould be provided with handles which are formed separately from the tubular outer member and the inner member. For example, the inner member 214 could be provided with a handle similar to the handle provided for the embodiment of the invention illustrated in FIG. 1.

[0162] Retainer

[0163] In the embodiment of the invention illustrated in FIGS. 11-15, the anchor 30cis a suture anchor and the legs 62cand 64cof the suture 32care positioned in the open slot 102cof the suture anchor inserter apparatus 20c. In the embodiment of the invention illustrated in FIGS. 16-18, a retainer member is provided in association with the anchor inserter apparatus 20cto hold the legs of the suture in the slot when the anchor is used with a suture. Since the embodiment of the invention illustrated in FIGS. 16-18 has a construction which is similar to the construction of the embodiment of the invention illustrated in FIGS. 11-15, similar numerals will be utilized to designate similar components, the suffix letter “d” being associated with the is numerals of FIGS. 16-18 to avoid confusion.

[0164] The suture anchor inserter apparatus 20d(FIG. 16) includes a tubular outer member 94dhaving a cylindrical passage 204d. A cylindrical inner member 92dextends into the passage 204din the outer member 94d. A straight slot 102dis formed in the tubular outer member 94dand extends between opposite ends of the tubular outer member 94d. The slot 102dforms a passage through a handle 22dwhich is integrally formed as one piece with the tubular outer member 94d.

[0165] In accordance with a feature of this embodiment of the invention, a suture retainer sleeve 270 is rotatably mounted on the tubular outer member 94d. The suture retainer sleeve 370 has a generally cylindrical configuration. A slot 272 extends between axially opposite ends of the suture retainer sleeve 270. The suture retainer sleeve 270 spans the slot 102d(FIGS. 16 and 17) to retain the legs 62dand 64dof the suture 32din the slot. Thus, the sleeve 270 holds the suture legs 62dand 64din the slot 102dwith the suture legs extending between opposite ends of the slot.

[0166] When the anchor inserter apparatus 20dis being assembled, the retainer sleeve 270 is rotated in a counterclockwise direction (as viewed in FIG. 17) relative to the tubular outer member 94dto move the slot 272 in the retainer sleeve 270 into alignment with the slot 102dof the tubular outer member 94. This enables the legs 62dand 64dof the suture 42dto be positioned in the slot 102din the tubular outer member 94d. Once the legs 62dand 64dhave been positioned in the slot 102din the tubular outer member 94d, in the manner illustrated in FIG. 18, the suture retainer sleeve 270 is rotated in a clockwise direction to again span the slot 102dand block movement of the legs 62dand 64dof the suture 30dout of the slot (FIG. 17).

[0167] In the embodiment of the invention illustrated in FIGS. 16-18, a cylindrical suture retainer sleeve or ring 270 is rotatably mounted on the tubular outer member 94dand is movable between a closed position blocking the slot 102dand an open position providing access to the slot 102d. However, it is contemplated that any desired type of member could be mounted on the tubular outer member 94dto block the slot 102dand retain the suture 32din the slot. In the embodiment of the invention illustrated in FIGS. 16-18, the suture retainer sleeve 270 extends along only a portion of the length of the tubular outer member 94d. If desired, the suture retainer sleeve 270 could have a substantially greater axial extent so as to span a greater axial length of the slot 102dwhen the suture retainer sleeve 270 is in the closed position illustrated in FIG. 17.

[0168] The suture retainer sleeve 270 has been illustrated in FIG. 16 as being mounted on a suture anchor inserter apparatus 20dhaving the same construction as the anchor inserter apparatus 20cof FIGS. 11-15. However, the suture retainer sleeve 270 could be utilized in conjunction with the embodiment of the invention illustrated in FIGS. 1-5 if desired. If this was done, the suture retainer sleeve 270 would be mounted on the outer member 94.

[0169] Anchor Retainer

[0170] In the embodiments of the invention illustrated in FIGS. 11-18, the anchor 30cis held against movement relative to the tubular outer member 94cdue to interference between the suture anchor 30cand the inner side surface 230 of the passage 204 in the tubular outer member 94c. In the embodiment of the invention illustrated in FIGS. 19-22, there is no interference between the anchor and the inner side surface of the tubular outer member throughout a major portion of the length of the tubular member. The leading end portion 242 (FIG. 11) of the tubular outer member 94cis provided with a retainer which is effective to hold the anchor against movement. Since the embodiment of the invention illustrated in FIGS. 19-21 is generally similar to the embodiments of the invention illustrated in FIGS. 1-18, similar numerals will be utilized to designate similar components, the suffix letter “e” being associated with the numerals of FIGS. 20-22 to avoid confusion.

[0171] The anchor inserter apparatus 20ehas the same general construction as the anchor inserter apparatus 20cof FIG. 11. The anchor inserter apparatus 20e(FIG. 19) includes a tubular outer member 94ehaving a slot 102e. The slot 102eextends between openings at axially opposite ends of the tubular outer member 94c. Thus, the slot 102eextends to an exit opening 208ein the leading end portion 242eof the tubular outer member 94e.

[0172] An inner member 92e(FIGS. 20-22) is telescopically received in a passage 204e(FIGS. 21 and 22) in the tubular outer member 94e. The cylindrical inner member 92ehas a diameter which is less than the diameter of the passage 204ein the tubular outer member 94e. The inner member 92ehas a leading end portion 218e(FIGS. 20-22) which is engageable with a suture anchor 30e.

[0173] The anchor 30e(FIG. 20) is a suture anchor and has a pair of parallel passages 236eand 238ewhich extend diametrically through the anchor 30e. A suture 32eextends through the cylindrical passages 236eand 238ein the suture anchor 30e. Thus, the suture 32ehas an outer leg 62ewhich extends through the passage 238ein the suture anchor 30e. Similarly, the suture 32ehas an inner leg 64ewhich extends through the passage 236ein the suture anchor 30e. A connector section 66e(FIGS. 21 and 22) of the suture 32eextends along an outer side surface of the suture anchor 30eand interconnects the two legs 62eand 64e. The suture 32emay be omitted if desired.

[0174] In accordance with a feature of this embodiment of the invention, an anchor retainer or positioner 280 is provided in the leading end portion 242eof the tubular outer member 94eto hold the anchor 30ein a desired position relative to the tubular outer member. In the embodiment of the invention illustrated in FIGS. 19-22, the anchor retainer 280 is resiliently deflectable under the influence of force applied against the anchor retainer by a leading end portion 44eof the suture anchor 30e. The anchor retainer 280 then grips a cylindrical outer side surface 50eof the anchor 30eto hold the anchor against movement relative to the tubular outer member 94e. The anchor 30emay be a suture anchor

[0175] The tubular outer member 94eis initially formed so that the inner side surface 230e(FIG. 19) of the passage 204etapers axially outward and radially inward from a relatively large diameter upstream or ahead of the leading end portion 242 of the tubular outer member to a relatively small size at the axially outer end of the tubular outer member 94e. Thus, the passage 204ein the tubular outer member 94etapers axially toward the right (as viewed in FIG. 19) to the exit opening 208e. The exit opening 208ehas a generally oval configuration formed by radially inwardly projecting end portions 284 and 286 of the tubular outer member 94e.

[0176] The passage 204ein the tubular outer member 94ehas a circular cross sectional configuration, as viewed in a plane extending perpendicular to the longitudinal central axis of the passage, throughout the length of the passage ahead of the leading end portion 242eof the tubular outer member 94e. This portion of the passage 204ehas a diameter which is slightly larger than the diameter of the suture anchor 30e. At the leading end portion 242eof the tubular outer member 94e, the passage 240etapers inwardly (FIG. 21) to the opening 208e. The opening 208ehas a cross sectional area, as viewed in a plane extending perpendicular to a longitudinal central axis of the passage 204e, which is smaller than the cross sectional area of the portion of the passage 204eahead of the leading end portion 242eof the tubular outer member 94eand smaller than the cross sectional area of the anchor 30e.

[0177] The slot 102ein the tubular outer member 94e(FIG. 19) has a uniform width throughout the length of the slot ahead of the leading end portion 242eof the tubular outer member 94e. At the leading end portion 242eof the tubular outer member 94e, the width of the slot 102edecreases as the passage 240etapers inwardly to the opening 208e. At the opening 208e, the slot 102ehas a width which is smaller than the width of the slot 102eahead of the leading end portion of the tubular outer member 94e.

[0178] Upon movement of the anchor 30ethrough the leading end portion 242eof the tubular outer member 94e, the leading end portion 50eof the anchor 30eapplies force against the outer end portion 242eof the tubular outer member 94eto resiliently deflect the end portions 284 and 286 of the tubular member 94eradially outward. This results in the tubular outer member 94ebeing resiliently expanded so that the passage 204eis substantially the same size throughout the length of the passage. As the leading end portion 242eof the tubular outer member 94eis resiliently expanded, the width of the portion of the slot 102ein the leading end portion of the tubular outer member increases. This results in the slot 102ehaving a substantially uniform width throughout its length.

[0179] During assembly of the anchor inserter apparatus 20e, the anchor 30eis moved through an entrance opening, corresponding to the entrance opening 206 of FIG. 11, to the passage 204e. The cylindrical outer side surface 50e(FIG. 21) of the suture anchor 30ehas a diameter which is less than the diameter of the passage 204euntil the suture anchor moves to the leading end portion 242eof the tubular outer member 94e. Therefore, the anchor 30ecan be readily moved along the passage 204efrom an entrance opening to the radially inwardly tapering leading end portion 242eof the tubular member 94eunder the influence of either gravity and/or force transmitted from the suture 32eto the anchor 30e.

[0180] When the leading end portion 44eof the anchor 30eencounters the inwardly tapering leading end portion 242eof the tubular outer member 94e(FIG. 21) continued movement of the anchor 30etoward the right (as viewed in FIG. 21) is impeded. The inner member 92eis then moved along the passage 204euntil the axially tapered leading end portion 218eof the inner member engages a trailing end portion 38eof the anchor 30e. An axial force is then transmitted from the inner member 92eto the trailing end portion 38eof the anchor 30e. This force presses the leading end portion 44eof the anchor 30eagainst the inwardly sloping end portions 284 and 286 (FIG. 19) of the tubular outer member 94eat the axially tapering leading end portion of the passage 204e.

[0181] The force applied against the inwardly projecting portions 284 and 286 of the tubular outer member 94eby the leading end portion 44eof the anchor 30eresiliently expands the tubular outer member 94efrom the configuration illustrated in FIG. 21 to the configuration illustrated in FIG. 22. As this occurs, the axially tapering end portion of the passage 204ein the leading end portion 242eof the tubular outer member 94eis resiliently expanded to a cylindrical configuration (FIG. 22). Once this has occurred, the anchor 30eis gripped by the leading end portion 242eof the tubular outer member 94e.

[0182] The inner side surface 230e(FIG. 22) of the passage 204ethrough the tubular outer member 94eis pressed firmly against the cylindrical outer side surface 50eof the suture anchor 30e. This enables the retainer 280 to securely hold the suture anchor in the position shown in FIG. 22. At this time the trailing end portion 38eof the anchor 30eis disposed in the passage 204eand the leading end portion 44eof the anchor 30eextends outward from the tubular outer member 94e.

[0183] After the specific anchor 30ehas been moved to the position shown in FIG. 22, the legs 62eand 64eof the suture 32eare tensioned and positioned in the slot 102ein the manner previously explained in conjunction with the embodiment of the invention illustrated in FIG. 11. The suture legs 62eand 64eextend through axially opposite end portions of the slot 102e. A retainer sleeve, corresponding to the retainer sleeve 270 of FIGS. 16-18, may be provided in association with the tubular outer member 94eof FIGS. 19-22 to retain the legs 62eand 64eof the suture 32ein the slot 102ein the manner previously explained in conjunction with the embodiment of the invention illustrated in FIGS. 16-18. Alternatively, a retainer, such as adhesive tape, could be used to hold the suture legs 62eand 64ein the slot 102e.

[0184] It should be understood that the tubular outer member 94eis provided with a handle, corresponding to the handle 22cof FIG. 11. The slot or passage 102eextends through the handle on the tubular outer member 94ein the same manner as previously described in conjunction with the embodiment of the invention illustrated in FIG. 11. The suture legs 62eand 64eextend through an open end of the slot 102ein the handle to enable a surgeon to manually engage the suture legs. A handle, corresponding to the handle 214 of FIG. 11, may be provided in association with the inner member 92eof FIGS. 20-22.

[0185] Once the anchor inserter apparatus 20ehas been assembled, in the manner previously described, the suture anchor inserter apparatus is used to position the anchor 30erelative to body tissue. The anchor inserter apparatus 20eis used to position the anchor 30erelative to body tissue in the same manner previously explained in conjunction with the embodiment of the invention illustrated in FIGS. 11-15. Once the anchor 30ehas been positioned relative to body tissue, the suture legs 62eand 64eare easily disengaged from the open slot 102ein the tubular outer member 94e.

[0186] In the embodiment of the invention illustrated in FIGS. 19-22 a single slot 102eextends throughout the axial length of the tubular outer member 94eto accommodate the legs 62eand 64eof the suture 32e. If desired, the tubular outer member 94ecould be formed without the slot. If this was done, the outer end portion 242eof the tubular outer member 94ewould still be axially tapered. In the absence of the slot 102e, the legs 62eand 64eof the suture 32ewould be disposed in the passage 204eand would be enclosed by the tubular outer member 94e. However, the suture 32ecould be omitted if desired.

[0187] It is believed that it will be preferred to provide the slot 102ein the tubular outer member 94ein order to facilitate positioning of the legs 62eand 64eof the suture 32erelative to the anchor inserter apparatus 20eduring assembly of the apparatus when the anchor is a suture anchor. In addition, the slot 102efacilitates separating the anchor inserter apparatus 20efrom the suture 32eafter the suture anchor 30ehas been positioned in body tissue in the manner previously explained. Of course, the anchor 30ecould have any known construction.

[0188] In the embodiment of the invention illustrated in FIGS. 19-22 the slot 102eextends throughout the axial extent of the tubular outer member 94e. It is contemplated that one or more slots, which extend for a distance less than the axial extent of the tubular outer member 94e, could be provided in the tubular outer member. For example, three slots could be provided at equally spaced intervals about the circumference of the tubular outer member 94e. Each of these three slots may have a length which is approximately two to four times as great as the length of a suture anchor 30e. If a plurality of slots with a length which is less than the axial extent of the tubular outer member 94eare used, the portion of the tubular member between each of the slots may extend radially inward toward the central axis of the tubular outer member 94eand be resiliently deflected by engagement with the leading end portion 44eof the suture anchor 30e.

[0189] In the embodiment of the invention illustrated in FIGS. 19-22 the tubular outer member 94eis formed of metal and the anchor retainer 280 is formed by deflecting the edge portions 284 and 286 of the tubular outer member radially inward toward the central axis of the tubular outer member 94e. It should be understood that the extent of deflection of the edge portion 286 is exaggerated in FIG. 21 in order to provide a clear schematic illustration of the manner in which the edge portions 284 and 286 are deflected. It is contemplated that the extent of deflection of the edge portions 284 and 286 will be less than has been illustrated in FIG. 21.

[0190] If desired, the tubular outer member 94ecould be molded as a single piece of polymeric material. If the tubular outer member 94eis molded as single piece of polymeric material, the inwardly extending edge portions 284 and 286 would be formed in the tubular outer member 94eas originally molded. The side wall of the tubular outer member 94ewould have sufficient flexibility to enable the edge portions 284 and 286 to be resiliently deflected under the influence of force applied against them by the leading end portion 44eof the suture anchor 30e.

[0191] In the embodiment of the invention illustrated in FIGS. 19-22 the inner member 92eis moved toward the right (as viewed in FIGS. 21 and 22) relative to the tubular outer member 94e. The force transmitted from the inner member 92eto the anchor 30epresses the leading end portion 44eof the anchor against the deflected portions 284 and 286 of the tubular outer member 94e. This cams or forces the deflected portions 284 and 286 radially outward as the anchor 30emoves from the position shown in FIG. 21 to the position shown in FIG. 22. However, if desired, the tubular outer member 94ecould be moved relative to the inner member 92e. Thus, the inner member 92ecould be maintained stationary in the position shown in FIG. 21. The tubular outer member 94ewould be moved toward the left (as viewed in FIG. 21) to effect relative movement between the inner and outer members 92eand 94e. As this relative movement occurs, the inwardly projecting edge portions 284 and 286 of the tubular outer member 94ewould be cammed or forced radially outward. Relative movement between the inner member 92eand the tubular outer member 94ewould be interrupted when the tubular outer member had moved to the position illustrated in FIG. 22 relative to the inner member.

[0192] Retainer Recess

[0193] In the embodiment of the invention illustrated in FIGS. 19-22 the tubular outer member 94egrips the cylindrical outer side surface 50eof the suture anchor 30eto hold the suture anchor in a desired position. In the embodiment of the invention illustrated in FIG. 23, the tubular outer member grips a recess formed in the suture anchor to hold the suture anchor in the desired position. Since the embodiment of the invention illustrated in FIG. 23 is generally similar to the embodiment of the invention illustrated in FIGS. 1-22, similar numerals will be utilized to designate similar components, the suffix letter “f” being associated with the numerals of FIG. 23 to avoid confusion.

[0194] The anchor inserter apparatus 20fof FIG. 23 has the same general construction as the anchor inserter apparatus 20cof FIG. 11. The anchor inserter apparatus 20f(FIG. 23) includes a cylindrical tubular outer member 94fhaving a slot 102f. The straight slot 102fextends between openings at axially opposite ends of the tubular outer member 94f. Thus, the slot 102fextends to an exit opening 208fin the leading end portion of the tubular outer member 94f.

[0195] A cylindrical inner member 92fis telescopically received in a passage 204fin the tubular outer member 94f. The cylindrical inner member 94fhas a diameter which is less than the diameter of the passage 204fin the tubular outer member 94f. The inner member 92fhas a leading end portion which is engageable with the anchor 30f.

[0196] In the embodiment illustrated in FIG. 23, the anchor 30fhas a tubular configuration. Thus, the anchor 30fhas a longitudinally extending central passage 28fwhich extends between a trailing end portion 38fand a leading end portion 44fof the anchor 30f.

[0197] Although the anchor 30fcould have many different constructions, the specific anchor illustrated in FIG. 23 is a suture anchor. Therefore, the anchor 30fis used with a suture 32f. The suture 32fhas outer and inner legs 62fand 64fwhich extend through passages 236fand 238fwhich extend radially through the suture anchor 30f. The outer and inner legs 62fand 64fof the suture 30fare interconnected by a connector section 66fwhich extends along an outer side surface of the anchor 30f.

[0198] In accordance with a feature of this embodiment of the invention, the anchor 30fis provided with an annular recess or groove 300 (FIG. 23) which extends around the anchor 30fand has a central axis which is coincident with a longitudinal central axis of the suture anchor. The annular recess or groove 300 extends radially inward from a cylindrical outer side surface 50fof the anchor 30f. The recess or groove 300 is disposed midway between the radial passages 236fand 238fwhich extend through the anchor 30f. In the illustrated embodiment of the invention, the recess 380 has a gently curving configuration to avoid stress concentrations. However, the recess 300 could be more sharply defined if desired.

[0199] The tubular outer member 94fhas an annular projection 304 which extends radially inward from an inner side surface 230fof the tubular outer member 94f. The slot 102fextends axially through the annular projection 304. The annular projection 304 has a central axis which is coincident with a longitudinal central axis of the tubular outer member 94fand extends parallel to a longitudinal central axis of the slot 102f. The portion of the passage 204fahead of the annular projection 304 has a diameter which is larger than the diameter of the trailing and leading end portions 38fand 44fof the anchor 30f.

[0200] The annular projection 304 has an inside diameter which is less than the diameter of the trailing and leading end portions 38fand 44fof the anchor 30f. Prior to engagement with the anchor 30f, the annular projection 304 has an inside diameter which is slightly less than the outside diameter of the recess 300 in the suture anchor. This results in the annular projection 304 being deflected radially outward when the annular projection engages the recess 300 in the suture anchor 30f. Therefore, the annular projection 304 firmly grips the anchor 30fwhen the annular projection engages the recess 300 (FIG. 23).

[0201] When the annular projection 304 engages the recess 300, the trailing end portion 38fof the anchor 30fis disposed in a passage 204fin the tubular outer member 94f. The leading end portion 44fof the anchor 30fextends axially outward from the tubular outer member 94f. The distance which the anchor 30fextends outward from the tubular outer member 94fis determined by the location of the annular projection 304frelative to the axially outer end of the tubular outer member 94fand the location of the annular recess relative to the leading end portion 44fof the anchor 30f.

[0202] When the anchor 30fis to be moved to the position shown in FIG. 23, the anchor is positioned in the passage 204fand moved along the passage until the leading end portion 44fof anchor 30fengages the annular projection 304. The inner member 92fthen applies force against the trailing end portion 38fof the anchor 30fto press the leading end portion 44fof the anchor against the annular projection 304. Force transmitted from the leading end portion 44fof the anchor 30fto the annular projection 304 causes the tubular outer member 94fto resiliently expand. This resilient expansion of the tubular member 94fincreases the inside diameter of the annular projection 304.

[0203] As the anchor 30fcontinues to move toward the right (as viewed in FIG. 23), the annular projection 304 expands radially and moves into engagement with a cylindrical outer side surface 50fof the anchor 30f. At this time, the width of the slot 102fwill have increased from an initial width to accommodate the radial expansion of the annular projection 304. Continued axial movement of the inner member 92ftoward the right (as viewed in FIG. 23) moves the passage 238fthrough the anchor 30fpast the annular projection 304. As this occurs, the annular projection 304 moves into engagement with the annular recess 300 in the suture anchor 30f.

[0204] The annular projection 304 resiliently grips the outer side surface of the suture anchor 30f. Sloping side surfaces on the projection 304 cooperate with sloping side surfaces on the recess 300 in the suture anchor 30fto cam or force the suture anchor to a position in which the annular projection is centered in the annular recess in the suture anchor 30f. As this occurs, the width of the slot 102fdecreases. The rightward (as viewed in FIG. 23) force applied by the inner member 92fagainst the anchor 30fis interrupted when the anchor 30fhas moved to the position shown in FIG. 23. At this time, the end portion 280fof the tubular outer member 94fis resiliently expanded and the slot 102fhas a width which is greater than its undeflected width.

[0205] In the embodiment of the invention illustrated in FIG. 23, both the recess 300 and projection 304 have an annular configuration. Therefore, the annular projection will engage the annular recess even if the anchor 30fis rotated about its longitudinal central axis to a position offset from the position shown in FIG. 23. However, if desired, the recess 300 could extend for a distance less than the entire circumference of the suture anchor 30fand the projection 304 could extend for a distance which is less than the entire circumference of the tubular outer member 94f. For example, the recess 300 and the projection 304 could have a generally circular conical configuration if desired.

[0206] In the foregoing description, it has been assumed that the inner member 92fis moved axially relative to the outer member 94fto move the suture anchor 30fto the position shown in FIG. 23. However, if desired, the tubular outer member 94fcould be moved relative to the inner member 92f. Thus, the tubular outer member 94fcould be moved toward the left (as viewed in FIG. 23) relative to the inner member 92fto effect engagement of the annular recess 300 on the anchor 30fwith the annular projection 304 on the tubular outer member 94f.

[0207] In addition, the foregoing description has assumed that the anchor 30fwill be moved from the left toward the right relative to the tubular outer member 94fin order to engage the annular projection 304. This assumes that the anchor 30fwill be inserted into the passage 204fat an opening, corresponding to the opening 206 of FIG. 11, adjacent to a handle, corresponding to the handle 22cof FIG. 11. However, if desired, the anchor 30fcould be inserted into the passage 204fthrough the exit opening 208fin the tubular outer member 94f.

[0208] If the anchor 30fis inserted into the passage 94fthrough the exit opening 208f, the trailing end portion 38fof the anchor 30fwould be moved through the opening 208finto engagement with the annular projection 304. An axially directed force would then be applied to the leading end portion 44fof the anchor 30f. This force would press the trailing end portion 38fof the anchor 30fagainst the annular projection 304. Force transmitted from the trailing end portion 38fof the anchor 30fwould cause the annular projection 304 to expand with a resulting expansion of the slot 102f. As this occurs, the projection 304 would move into engagement with the outer side surface 50fof the anchor 30fadjacent to the trailing end portion 38fof the anchor.

[0209] The continued application of a leftward (as viewed in FIG. 23) force to the leading end portion of the anchor 30fwould move the trailing end portion 38fof the suture anchor further into the passage 204f. As this occurs, the annular projection 304 on the tubular outer member 94fwould move into engagement with the annular recess 300 in the anchor 30f.

[0210] It is believed that the foregoing front end loading, that is movement of the anchor 30finto the passage. 204fthrough the exit opening 208f, may be preferred during assembly of the apparatus 20f. This is because the anchor 30fand tubular outer member 94fare moved through a relatively short distance relative to each other to enable the annular projection 304 to engage the recess 300 in the anchor 30f.

[0211] When the anchor 30fis to be positioned in body tissue, the leading end portion 44fof the anchor is inserted into the body tissue. Since the leading end portion 44fof the anchor 30fextends outward from the tubular outer member 94f, locating the anchor in a desired position relative to body tissue is facilitated. In addition, the slot 102fenables a surgeon to more easily visualize the position of the anchor 30frelative to the body tissue. During initial positioning of the anchor 30frelative to body tissue, the projection 304 grips the recess 300 to hold the anchor 30fagainst movement relative to the tubular outer member 94f. If desired, the suture 32fcould be omitted.

[0212] Once the leading end portion 44fof the anchor 30fhas been initially positioned relative to the body tissue by movement of the tubular outer member 94f, the tubular outer member and inner member 92fare moved relative to each other to move the anchor 30fto a desired depth in the body tissue. Thus, the inner member 92fis moved relative to the outer member 94fto apply force against the trailing end portion 38fof the anchor 30f. This force is effective to resiliently expand the annular projection 304 and slot 102fand move the anchor 30fout of engagement with the annular projection and into body tissue. Alternatively, the inner member 92fcould be maintained stationary and the outer member 94fmoved relative to the inner member to move the anchor 30finto the body tissue.

[0213] Once the anchor 30fhas been separated from the tubular outer member 94fand moved to a desired depth in the body tissue, the orientation of the anchor may or may not be changed relative to the body tissue. When the anchor 30fis associated with the suture 32f, the legs 62fand 64fof the suture are tensioned to pivot the anchor. This results in the anchor moving from an orientation in which a longitudinal central axis of the anchor is aligned with a longitudinal central axis of the tubular outer member 94fto an orientation in which the longitudinal central axis of the anchor extends transverse to the longitudinal central axis of the tubular outer member 92f. The manner in which this is accomplished is the same as is disclosed in the aforementioned U.S. Pat. No. 5,403,348.

[0214] After the anchor 30fhas been positioned relative to body tissue, the suture 32fis disengaged from the slot 102fin the tubular outer member 94fand handle (not shown). This is easily accomplished by moving the suture legs sideways out of the open slot 102f.

[0215] In the embodiment of the invention illustrated in FIG. 23, the slot 102fextends between axially opposite ends of the tubular outer member 94f. If desired, one or more slots which extend only part way along the length of the tubular outer member 94fcould be provided. For example, three or four slots which extend from the exit opening 208fa short distance past the annular projection 304 could be provided in the tubular outer member 94f. These slots would enable the annular projection 304 to flex radially outward during relative movement between the suture anchor 30fand the annular projection 304. It is also contemplated that the annular projection 304 could be constructed so as to be radially flexible without the provision of slots in the tubular outer member 94f.

[0216] In the embodiment of the invention illustrated in FIG. 23, the annular projection 304 is integrally formed as one piece with the tubular outer member 94f. It is contemplated that the annular projection 304 could be formed separately from the tubular outer member 94f. For example, the annular projection 304 could be replaced by a resiliently expandable annular ring mounted in the passage 204fin the tubular outer member 94f. Alternatively, a resilient annular ring could be mounted on the outside of the tubular outer member 94fand extend through chordal slots formed in the tubular outer member into the passage 204fto engage the recess 300 in the anchor 30f.

[0217] Anchor Retainer

[0218] In the embodiment of the invention illustrated in FIG. 23, the anchor retainer 280fengages a recess 300 in the suture anchor 30f. In the embodiment of the invention illustrated in FIGS. 24 and 25, an anchor retainer engages a passage in the anchor. A suture may extend through the passage. Since the embodiment of the invention illustrated in FIGS. 24 and 25 is generally similar to the embodiment of the invention illustrated in FIGS. 1-23, similar numerals will be utilized to designate similar components, the suffix letter “g” being associated with the numerals of FIGS. 24 and 25 to avoid confusion.

[0219] An anchor inserter apparatus 20ghas the same general construction as the anchor inserter apparatus 20cof FIG. 11. Thus, the anchor inserter apparatus 20gincludes a tubular outer member 94ghaving a passage 204gwhich extends between an exit opening 208gat a leading end portion 242gof the tubular outer member 94gand an entrance opening (not shown) at the opposite end of the tubular outer member 94g. A straight slot 102gextends between axially opposite ends of the tubular outer member 94g. An inner member, not shown, corresponding to the inner member 92cof FIG. 11, is axially movable in the passage 204g.

[0220] In accordance with a feature of this embodiment of the invention, an anchor retainer 280g(FIG. 24) is engageable with a passage 236gwhich forms a recess in an anchor 30g(FIG. 25). In the illustrated embodiment of FIGS. 24 and 25, a suture 32ghas an inner leg 64gwhich extends through the passage 236gto a connector section 66gof the suture. The anchor 30ghas the same general construction as the suture anchor 30fof FIG. 23. However, the anchor 30g(FIG. 25) does not have an annular recess corresponding to the recess 300 in the anchor 30fof FIG. 23.

[0221] The retainer 280g(FIGS. 24 and 25) has a circular, generally hemispherical-shaped, projection 304gwhich extends radially inward from an inner side surface 230gof the passage 204gin the tubular outer member 94g. The projection 304gis formed by indenting the outside of the tubular outer member 94g. The hemispherical projection 304ghas a maximum diameter which is greater than the diameter of the passage 236g(FIG. 25) which extends radially through the suture anchor 30g. The projection 304gis disposed diametrically opposite from the slot 102g(FIG. 24).

[0222] The projection 304gextends through an open end 310 (FIG. 25) of the passage 236gwhich forms a recess in the anchor 30g. The projection 304gengages the open end portion 310 of the passage 236gto hold the anchor 30gagainst axial movement relative to the tubular outer member 94g(FIG. 25). The projection 304gpresses the leg 64gof the suture 32gagainst the open end 310 of the passage 236gto hold the suture 32gagainst movement relative to the anchor 30g. The projection 304galso presses a portion of a cylindrical outer side surface 50gon the anchor 30gagainst a portion of the inner side surface 230gof the passage 204gadjacent to the slot 102g(FIG. 24). If desired, a closed ended recess could be substituted for the open ended recess formed by the passage 236gand the suture 32gomitted.

[0223] When the anchor 30gis to be inserted into the anchor inserter apparatus 20gwith the suture 32gconnected with the anchor, the anchor may be moved through an entrance opening, corresponding to the entrance opening 206 of FIG. 11, and into the passage 204g. The anchor 30gis moved along the passage 204guntil the leading end portion (not shown) of the anchor 30gengages the projection 304g.

[0224] An inner member, corresponding to the inner member 92cof FIG. 11, then applies an axial force against the trailing end portion 38gof the anchor 30g. This causes the leading end portion of the anchor 30gto cam or force the projection 304gradially outward. As the projection 304gis forced radially outward by the anchor 30g, the width of a portion of the slot 102g(FIG. 24) in the end portion 242gof the tubular outer member 94gincreases and the end portion of the tubular outer member is resiliently expanded.

[0225] Continued rightward (as viewed in FIGS. 24 and 25) movement of the anchor 30g(FIG. 25) relative to the tubular outer member 94gmoves the projection 304ginto alignment with a leading passage through the anchor 30g, that is into alignment with a passage corresponding to the passage 238fin the anchor 30fof FIG. 23. If desired, the anchor 30gcould be positioned relative to the tubular outer member 94gwith the projection 304gengaging the leading passage, that is the passage corresponding to the passage 238fof FIG. 23, in the suture anchor 30g. However, it is believed that it will be preferred to have the anchor 30gextend further outward from the tubular outer member 94g. Therefore, the application of force against the trailing end portion 38gof the anchor 30gby the inner member, corresponding to the member 92cof FIG. 11, is continued.

[0226] The continued application of force to the trailing end portion 38gof the anchor 30gdisengages the projection 304gfrom the leading passage through the anchor 30g. Continued rightward (as viewed in FIG. 25) axial movement of the anchor 30gmoves the projection 304ginto alignment with the passage 236gin the anchor 30g. When the projection 304gsnaps into the open end portion 310 of the passage 236g, the application of force to the trailing end portion 38gof the anchor 30gis interrupted. At this time, the anchor 30gis held against movement relative to the tubular outer member 94gby engagement of the projection 304gwith the open end portion 310 of the passage 236g.

[0227] The foregoing explanation has assumed that the anchor 30gis moved into the passage 204gat the entrance opening, corresponding to the entrance opening 206 of FIG. 11. However, the anchor 30gcould be moved into the passage 204gthrough the exit opening 208gif desired. When the anchor 30gis inserted through the exit opening 208g, the trailing end portion 38gof the anchor 30gmoves into engagement with the projection 304g. Continued leftward (as viewed in FIG. 25) movement of the anchor 30gresiliently deflects the projection 304g. As this occurs, the width of the slot 102gincreases.

[0228] As the anchor 30gcontinues to move toward the left (as viewed in FIG. 25) relative to the projection 304g, the projection engages the outer side surface 50gof the anchor 30gand slides along the outer side surface. Continued leftward movement of the anchor 30grelative to the projection 304gresults in the projection moving into engagement with the open end portion 310 of the passage 236gthrough the suture anchor 30g. Once this occurs, the anchor 30gis held against axial movement relative to the tubular outer member 94g.

[0229] After the anchor inserter apparatus 20ghas been assembled, in the manner previously described, the apparatus is used to position the anchor 30grelative to body tissue in the same manner as previously described in conjunction with FIGS. 13-15. After the anchor 30ghas been positioned relative to an opening in bone or other body tissue, in the manner illustrated in FIG. 13, the inner member is moved relative to the tubular outer member 94g. The force applied against the trailing end 38gof the anchor 30gdisengages the anchor from the projection 304g.

[0230] Continued relative movement between the inner member and tubular outer member 94gmoves the anchor 30gout of the passage 204gin the tubular outer member. When the anchor 30ghas moved to the desired depth into the body tissue, the orientation of the anchor may be changed by tensioning the legs of the suture 32g. This pivots or toggles the anchor 30gin the same manner as previously described in conjunction with FIGS. 14 and 15.

[0231] The anchor 30gillustrated in FIG. 25 has the same tubular construction as the anchor 30fof FIG. 23. However, the anchor 30gcould have the solid cylindrical construction of the suture anchor 30eof FIGS. 21 and 22 if desired. In fact, the anchor 30gcould have any desired construction. For example, the anchor 30gcould have a polygonal construction similar to that in the aforementioned U.S. Pat. No. 5,549,630. Alternatively, the anchor could have any one of the constructions illustrated in the aforementioned U.S. Pat. No. 5,403,348.

[0232] In the embodiment of the invention illustrated in FIGS. 24 and 25, the projection 304gis integrally formed as one piece with the tubular outer member 94g. However, it is contemplated that the projection 304gcould be formed separately from the tubular outer member 94g. For example, the projection 304gcould be provided by a spring loaded plunger.

[0233] The use of such a spring loaded plunger would eliminate the necessity of resiliently deflecting the tubular outer member 94bas the projection 304gmoves into engagement with a anchor 30g. This would enable the slot 102gto be eliminated. However, it is believed that it will be preferred to retain the slot 102gin the tubular outer member 94gto facilitate positioning of the suture 32grelative to the tubular outer member during assembly and to facilitate disengagement of the tubular outer member 94gfrom the suture after the suture anchor 30ghas been positioned relative to body tissue in the manner explained in conjunction with FIGS. 13 through 15. Of course, if the suture 32 is omitted, the slot 102gcould be omitted.

[0234] Suture Anchor Retainer—Plural Projections

[0235] In the embodiment of the invention illustrated in FIGS. 24 and 25, the anchor retainer 280gincludes a single projection 304gwhich engages an open end portion 310 of the passage 236gformed in the anchor 30g. In the embodiment of the invention illustrated in FIGS. 26 and 27, a plurality of projections are provided to engage the open ends of a plurality of passages or recesses in an anchor. Since the embodiment of the invention illustrated in FIGS. 26 and 27 is generally similar to the embodiment of the invention illustrated in FIGS. 1-25, similar numerals will be utilized to designate similar components, the suffix letter “h” being associated with the numerals of FIGS. 26 and 27 to avoid confusion.

[0236] An anchor insertion apparatus 20h(FIG. 26) includes a tubular outer member 94hhaving a passage 204hwith an exit opening 208h. A slot 102hextends between axially opposite ends of the tubular outer member 94hin the same manner as previously explained in conjunction with the embodiment of the invention illustrated in FIG. 11. The anchor inserter apparatus 20hhas the same general construction as the anchor inserter apparatus 20cof FIG. 11.

[0237] In accordance with a feature of this embodiment of the invention, an anchor retainer 280hincludes a pair of identical projections 320 and 322. The projections 320 and 322 have the same generally hemispherical configuration as the projection 304gof FIGS. 24 and 25. The two projections 320 and 322 are disposed diametrically opposite from the slot 102h. The two projections 320 and 322 are integrally formed as one piece with the tubular outer member 94hby indenting the tubular outer member.

[0238] The two projections 320 and 322 engage open ends of passages 236hand 238hin the same manner as in which the single projection 304gof FIGS. 24 and 25 engages the open end portion 310 of the passage 236g(FIG. 25). Thus, the projection 320 engages an open end portion 324 of the passage 236h. Similarly, the projection 322 engages an open end portion 326 of the passage 238h(FIG. 27). If desired, closed ended recesses could be substituted for the open ended recesses formed by the passages 236hand 238h.

[0239] The suture 32hhas outer and inner legs 62hand 64hwhich extend through the passages 236hand 238h. The projections 320 and 322 extend into the open end portions 324 and 326 of the passages 236hand 238hand press the suture legs 62hand 64hagainst the open end portions of the passages. A connector section 66hextends between the open end portions 324 and 326 of the passages 236hand 238h. The two projections 320 and 322 press a portion of an outer side surface 50hon the anchor 30hagainst a portion of an inner side surface 230gof the passage 204hadjacent to the slot 102h. If desired, the suture 32hcould be omitted.

[0240] When the anchor inserter apparatus 20his to be assembled, the anchor 30hmay be inserted through the entrance opening, corresponding to the entrance opening 206 of FIG. 11, into the passage 204h(FIGS. 26 and 27). The anchor 30his then moved axially along the passage 200huntil a leading end portion 44hof the anchor engages the projection 320.

[0241] An inner member, corresponding to the inner member 92cof FIG. 11, applies force against a trailing end portion 38hof the anchor 30h. This force is transmitted from the leading end portion 44hof the anchor 30hto the projection 320 (FIG. 27). The force applied against the projection 320 resiliently deflects the tubular outer member 94h. As this occurs, the width of the slot 102hincreases.

[0242] As the anchor 30hcontinues to move forward, that is toward the right as viewed in FIG. 27, the open end portion 326 of the leading passage 230hthrough the anchor 30hmoves into alignment with the projection 320. As this occurs, the projection 320 snaps into the open end portion 326 of the passage 238h. Continued application of force to the trailing end portion 38hof the anchor 30hcontinues to move the anchor toward the right (as viewed in FIG. 27). As this occurs, the projection 320 becomes disengaged from the open end portion 326 of the passage 238hand the anchor moves toward the position shown in FIG. 27.

[0243] As the anchor moves into the position shown in FIG. 27, the projection 322 snaps into the open end portion 326 of the passage 238h. At the same time, the projection 320 snaps into the open end portion 324 of the passage 236h. This results in the anchor 30hbeing held in place by engagement of the projections 320 and 322 in the anchor 30h.

[0244] In the foregoing explanation, the anchor 30hwas moved from the entrance opening rightward (as viewed in FIG. 27) toward the exit opening 208hfrom the passage 204h. It is contemplated that the anchor 30hcould be inserted into the passage 204hin the tubular outer member 94hthrough the exit opening 208h. This would eliminate the necessity of moving the anchor 30hthrough a relatively long distance along the passage 204h.

[0245] The anchor inserter-apparatus 20his used to position the anchor 30h(FIG. 27) relative to body tissue in the same manner as previously explained in conjunction with the embodiments of the invention illustrated in FIGS. 1-25. Thus, an inner member, corresponding to the inner member 92cof FIG. 11, is moved relative to the outer member 94h. The force applied against the trailing end portion 38hof the suture anchor 30hresiliently deflects both of the projections 320 and 322 outwardly away from the slot 102fto disengage the projections from the open end portions 324 and 326 of the passages 236hand 238h. As this occurs, the width of the slot 102hincreases.

[0246] As the anchor 30hmoves axially outward from the position shown in FIG. 27, the suture passage 238 in the suture anchor 30hmoves out of the passage 204hin the tubular outer member 94h. As this occurs, the projection 322 resiliently snaps into the open end portion 324 of the suture passage 236hin the anchor 30h. The continued application of force against the trailing end portion 38hof the anchor 30hby the inner member (not shown) again resiliently deflects the projection 322 to disengage the projection 322 from the open end portion 324 of the suture passage 236h.

[0247] Continued movement of the inner member relative to the tubular outer member 94hseparates the anchor 30hfrom the tubular outer member. When the anchor 30hhas been moved to a desired position relative to the body tissue, the suture anchor may be pivoted to change its orientation in the manner disclosed in the aforementioned U.S. Pat. No. 5,403,348. The inner member and the tubular outer member 94hare then disengaged from the body tissue. The suture legs 62hand 64hcan be easily disengaged from the open slot 102h.

[0248] The foregoing description has assumed that positioning of the anchor 30hrelative to body tissue is to be accomplished by moving the inner member relative to the tubular outer member 94h. However, if desired, the inner member could be held stationary relative to the body tissue and the tubular outer member 94hmoved relative to the inner member to separate the anchor 30hfrom the tubular outer member.

[0249] Anchor Retainer Spring

[0250] In the embodiment of the invention illustrated in FIGS. 23-27, projections integrally formed with the tubular outer member have been utilized to retain the anchor in a desired position relative to the tubular outer member. In the embodiment of the invention illustrated in FIG. 28, a separate spring member is utilized to retain an anchor in a desired position relative to the tubular outer member. Since the embodiment of the invention illustrated in FIG. 28 is generally similar to the embodiment of the invention illustrated in FIGS. 11-27, similar numerals will be utilized to designate similar components, the suffix letter “j” being associated with the numerals of FIG. 28 to avoid confusion.

[0251] In the embodiment of the invention illustrated in FIG. 28, the anchor inserter apparatus 20jhas the same general construction as the anchor inserter apparatus 20cof FIG. 11. The anchor inserter apparatus 20jof FIG. 28 includes a cylindrical tubular outer member 94jand a cylindrical inner member 92j. An anchor retainer 280jretains an anchor 30jin a cylindrical passage 204jwhich extends axially through the tubular outer member 94j. The specific anchor 30jillustrated in FIG. 28 is a suture anchor.

[0252] A suture 32jis connected with the suture anchor 30j. The suture 32jhas outer and inner legs 62jand 64j. The legs 62jand 64jof the suture 32jare disposed in a slot 102jwhich extends between axially opposite ends of the tubular outer member 94j. If the suture 32jis omitted, the slot 102jcould be omitted.

[0253] In accordance with a feature of this embodiment of the invention, the anchor retainer 280jincludes a spring 330 which is disposed in a recess or slot 332 formed in the tubular outer member 94jopposite from the slot 102j. The spring 330 has a projection 336 which extends through an open end portion 310jof a passage 236jin the anchor 30j. Engagement of the projection 336 on the spring 330 with the open end portion 310jof the passage 236jholds the anchor 30jagainst movement relative to the tubular outer member 94j. The spring 330 is fixedly connected to the tubular outer member 94j.

[0254] When the anchor 30jis to be positioned in the anchor inserter apparatus 20j, the anchor 30jis inserted through an entrance opening to the passage 204j. Thus, the anchor 30jis inserted through an opening corresponding to the opening 206 of FIG. 11 adjacent to a handle portion of the anchor inserter apparatus 20j. The anchor 30jis moved along the passage 204juntil a leading end portion 44jengages the projection 236 on the spring 330.

[0255] The inner member 92jthen applies force against a trailing end portion 38jof the anchor 30j. Force is transmitted from the leading end portion 44jof the anchor 30jto the projection 336 to resiliently deflect the spring 330 radially outward, that is downward as viewed in FIG. 28. This results in the spring 330 being moved into the slot 332 in the tubular outer member 94j. In this embodiment of the invention, the width of the slot 102jremains constant as the anchor 30jmoves into and/or out of the tubular outer member 94j.

[0256] Continued movement of the anchor 30jtoward the exit opening 208jresults in the projection 336 engaging a cylindrical outer side surface 50jon the anchor 30jadjacent to the leading end portion 44jof the suture anchor. As the rightward (as viewed in FIG. 28) movement of the anchor 30jcontinues, the projection 336 on the spring 330 snaps into an open end portion of the passage 238jin the anchor.

[0257] Continued movement of the inner member 92jand anchor 30jtoward the right (as viewed in FIG. 28) relative to the tubular outer member 94jresults in the spring projection 336 moving out of engagement with the passage 238jand into engagement with the cylindrical outer side surface 50jof the anchor 30jat a location between the two passages 236jand 238j. As the rightward movement of the anchor 30jcontinues, the spring projection 336 snaps into the passage 236jin the anchor 30jin the manner illustrated schematically in FIG. 28. When this occurs, the application of force to the inner member 92jis interrupted. This results in the anchor 30jbeing held in place with the trailing end portion 38jdisposed in the passage 204jand the leading end portion 44jof the anchor 30jextending outward from the tubular outer member 94j.

[0258] In the embodiment of the invention illustrated in FIG. 28, the anchor 30jis formed from a solid cylindrical piece of material. The two radially extending passages 236jand 238jare formed in the solid piece of cylindrical material. However, if desired, the suture anchor 30jcould be formed with the tubular configuration illustrated in FIGS. 23, 25 and 27. Rather than engaging the open end recess formed by the passage 236j, the spring 330 could engage a closed end recess formed in the suture anchor 30jat a location offset from the passages 236jand 238j. It is contemplated that the suture anchor 30jcould have any desired configuration and could be used either with or without the suture 32j.

[0259] If desired, the anchor 30jcould be inserted into the passage 204jthrough the opening 208j. this would eliminate engagement of the spring 300 with the anchor passage 238jduring positioning of the anchor 30jin the suture anchor retainer 280j.

[0260] In the embodiment of the invention illustrated in FIG. 28, the slot 102jextends between axially opposite ends of the tubular outer member 94j. It is contemplated that the slot 102jcould be eliminated or that the slot could extend from the exit opening 208jthrough a distance which is shorter than the axial extent of the tubular outer member 94j. However, it is believed that it may be preferred to have the slot 102jextend between axially opposite ends of the tubular outer member 94jto facilitate positioning of the outer and inner suture legs 621 and 64jrelative to the tubular outer member 94j. In addition, by having the slot 102jextend between axially opposite ends of the outer member 94j, disengagement of the suture 32jfrom the tubular outer member is facilitated after the anchor 30jhas been positioned relative to body tissue. Of course, if the suture 32jis omitted, the slot 102jcould be omitted.

[0261] It is contemplated that the anchor 30jwill be positioned relative to body tissue in the same manner illustrated schematically in FIGS. 13-15. However, it should be understood that the anchor 30jcould be positioned relative to body tissue in a different manner if desired. It should be understood that the anchor inserter apparatus 20jcould be utilized to position the anchor 30jrelative to either hard body tissue, such as bone, or soft body tissue, such as a patient's skin or internal organs.

[0262] Anchor Retainer on Inner Member

[0263] In the embodiment of the invention illustrated in FIGS. 19-28, an anchor retainer has been disposed on a tubular outer member to retain the anchor against relative movement relative to the tubular outer member. In the embodiment of the invention illustrated in FIG. 29, an anchor retainer is disposed on an inner member to retain the anchor against movement relative to the inner member. Since the embodiment of the invention illustrated in FIG. 29 is generally similar to the embodiment of the invention illustrated in FIGS. 1-28, similar numerals will be utilized to designate similar components, the suffix letter “k” being associated with the numerals of FIG. 29 to avoid confusion.

[0264] An anchor inserter apparatus 20kincludes an inner member 92k(FIG. 29) which is fixedly connected with a handle (not shown) in the same manner as previously described in connection with the embodiment of the invention illustrated in FIGS. 1-3. A tubular outer member 94k, is axially slidable along the inner member 92k. A slot 102kextends between axially opposite ends of the outer member 94kand is axially aligned with a corresponding slot in the handle portion of the suture anchor inserter apparatus 20k. An anchor 30kis disposed on the axially outer end portion of the inner member 92kadjacent to a point 76kon the inner member 92k

[0265] In accordance with a feature of this embodiment of the invention, an anchor retainer 280kis mounted on the inner member 92kto hold the anchor 30kin a desired position relative to the anchor inserter apparatus 20k. The anchor 30kincludes a pair of radially extending passages 236kand 238kwhich extend diametrically through the anchor 30k. The passages 236kand 238khave a cylindrical configuration. The anchor 30khas a tubular configuration with a central passage 28kwhich is intersected by the suture passages 236kand 238k.

[0266] In accordance with a feature of the present invention, a spring 342 is mounted in a slot 344 in the inner member 92k. The spring 342 has a projection 346 which engages an inner end portion 348 of the passage 238k. The projection 346 extends into the passage 338kand holds the suture anchor 30kagainst movement relative to the inner member 92k. The spring 342 has an end portion 350 which is fixedly connected with the inner member 92k.

[0267] When the anchor 30kis to be positioned on the inner member 92k, the cylindrical axial passage 28kthrough the anchor 30kis aligned with the longitudinal central axis of the inner member 92kand the point 76k. At this time, the suture 32kmay be connected with the anchor 30k. Thus, the outer leg 62kof the suture 32kextends through the radial passage 238kin the anchor 30k. Similarly, the inner leg 64kextends through the passage 236kin the anchor 30k. A connector section 66kinterconnects the two legs 62kand 64kof the suture 32k.

[0268] As the trailing end portion 38kof the anchor 30kis moved past the point 76kand onto the cylindrical body of the inner member 92k, the trailing end portion 38kof the anchor 30kengages the projection 346 on the spring 342. The axial force applied against the spring 342 by the trailing end portion 38kof the anchor 30kdeflects the spring 342 into the slot 344. The projection 346 on the spring 342 then engages the open end portion 354 of the passage 236k.

[0269] Continued application of force against the anchor 30kresults in the spring 342 again being deflected into the slot 344. As the anchor 30kcontinues to move onto the inner member 92k, the projection 346 on the spring 342 snaps into the open end portion 348 of the passage 238k. This holds the anchor in the position shown in FIG. 29.

[0270] Once the anchor 30khas been positioned on the outer end portion of the inner member 92k, in the manner illustrated in FIG. 29, the outer and inner legs 62kand 64kof the suture 32kmay be positioned in the slot 102kin the tubular outer member 94k. The legs 62kand 64kof the suture 32kare also positioned in a slot in the handle of the anchor inserter apparatus. The slot (not shown) in the handle of the anchor inserter apparatus 20kis aligned with the slot 102kin the tubular outer member 94k.

[0271] Once the anchor 30khas been positioned on the outer end portion of the inner member 92k, the point 76kof the outer member 92kmay be utilized to pierce relatively soft body tissue. The anchor 30kis then separated from the inner member 92kand moved into the body tissue by movement of the tubular outer member 94kaxially outward along the inner member 92k. The orientation of the anchor 30kis then changed in the same manner as explained in conjunction with the embodiment of the invention illustrated in FIGS. 1-3.

[0272] In the embodiment of the invention illustrated in FIG. 29, the spring 342 has a single projection 346 which engages the inner open end portion 348 of the passage 238kin the anchor 30k. If desired, the projection on the spring could engage the inner open end portion 354 of the passage 236kon the anchor 30k. If this was to be done, the orientation of the spring 242 in the slot 344 would be changed by 180 so that the projection 346 would be adjacent to the left (as viewed in FIG. 29) end of the slot 344 while the end 350 of the spring would be adjacent to the right end of the slot 344. Alternatively, the spring 342 could be provided with two projections to engage each of the passages 236kand 238k.

[0273] Anchor Retainer

[0274] In the embodiment of the invention illustrated in FIGS. 19-22 the anchor retainer 280 projects radially inward from one side of the tubular outer member 94e(FIG. 19). In the embodiment of the invention illustrated in FIG. 30, the anchor retainer has an annular configuration and extends inward from the cylindrical side wall of the tubular outer member for the same distance throughout the extent of the tubular side wall. Since the embodiment of the invention illustrated in FIG. 30 is generally similar to the embodiment of the invention illustrated in FIGS. 1-29, similar numerals will be utilized to designate similar components, the suffix letter “m” being associated with the numerals of FIG. 30 to avoid confusion.

[0275] An anchor inserter apparatus 20mincludes a cylindrical tubular outer member 94mand a cylindrical inner member 92mwhich are disposed in a coaxial relationship. In accordance with a feature of this embodiment of the invention, an anchor retainer 280mis provided at one end, that is, the right end as viewed in FIG. 30, of the tubular outer member 94m. The anchor retainer 280mhas an annular configuration.

[0276] The annular retainer 280mhas an axially inner end portion 360 which is connected to a tubular cylindrical body 200mof the tubular outer member 94m. The retainer 280mhas an axially outer end portion 362 which defines a circular exit opening 208mhaving a central axis which is coincident with a longitudinal central axis of the cylindrical body 200mof the tubular outer member 94m. The anchor retainer 280mhas an annular inner side surface 364 which tapers radially inward and axially outward. Although the anchor retainer 280mhas been illustrated in FIG. 30 as having a plurality of slots to facilitate flexing of the anchor retainer, the slots could be omitted if desired.

[0277] When the anchor 30mis to be positioned in the anchor inserter apparatus 20m, the suture anchor 30mis moved through an opening at an end of the tubular outer member 94mopposite from the exit opening 208m. Thus, the anchor 30mis moved through an opening corresponding to the entrance opening 206 adjacent to the handle 22cof the embodiment of the invention illustrated in FIG. 11. At this time, the suture 32mmay be connected with the anchor 30m. Thus, an outer leg 62mof the suture 32mextends through a passage 236mformed in the suture anchor 30m. Similarly, the inner leg 64mof the suture 32mextends through a passage 238mformed in the suture anchor 30m. The two legs 62mand 64mof the suture 32mare interconnected by a connector section 66m.

[0278] In the embodiment of the invention illustrated in FIG. 30, the tubular outer member 94mhas a continuous cylindrical outer side surface. Thus, a slot, corresponding to the slot 102cof FIG. 11, is not formed in the tubular outer member 20m. Therefore, the outer and inner legs 62mand 64mof the suture 32mare received in a cylindrical passage 204mformed in the tubular outer member 94m. The suture legs 62mand 64mextend along an outer side surface of the cylindrical inner member 92m. Of course, if desired, a slot corresponding to the slot 102cof FIG. 11 could be formed in the tubular outer member 94m. If desired, the anchor 30mcould be designed for use without the suture 32m.

[0279] The pusher member 92mmoves the anchor 30mforward, that is toward the right as viewed in FIG. 30, until a leading end portion 44mof the anchor 30mengages the inwardly tapering or sloping side surface 364 of the anchor retainer 280m. When this occurs, the force applied by the inner member 92magainst the trailing end portion 38mof the anchor 30mis increased. This increased force deflects the annular anchor retainer 280mradially and axially outward and increases the diameter of the exit opening 208m. Thus, force applied by the leading end portion 44mof the anchor 30magainst the slotted annular surface 364 flexes sections 370 radially outward away from the longitudinal central axis of the tubular outer member 94m. As this occurs, the width of slots 372 between the sections 380 increases.

[0280] As the anchor 30mis moved toward the right (as viewed in FIG. 30) by the inner member 92mrelative to the outer member 94m, the sections 370 of the suture anchor retainer 280mmove into engagement with a cylindrical outer side surface 50mon the suture anchor 30m. As the anchor 30mcontinues to be pushed through the exit opening 208m, the sections 370 of the suture anchor retainer 280mslide along the outer side surface 50mon the suture anchor 30m. When the anchor 30mhas been moved to a desired position relative to the tubular outer member 94m, the outward movement of the anchor through the exit opening 208mis interrupted. At this time, the sections 370 of the anchor retainer 280mresiliently grip the cylindrical outer side surface 50mof the anchor 30mto hold the anchor against movement relative to the tubular outer member 94m.

[0281] When the anchor 30mis to be positioned relative to body tissue, the tubular outer member 94mand the cylindrical suture anchor 50mare aligned with an opening in the body tissue, in the same manner as is illustrated in FIG. 13. The tubular inner member 92mis then moved toward the right (as viewed in FIG. 30) to push the anchor 30minto the body tissue. The orientation of the anchor 30mrelative to the body tissue is then changed in the manner illustrated in FIG. 15 for the anchor inserter apparatus 22c.

[0282] It is preferred to move the anchor 30mto a position in which the leading end portion 44mof the anchor extends axially outward from the tubular outer member 94mand the retainer 280mgrips the outer side surface 50mof the anchor. However, the anchor 30mcould remain completely within the passage 204min the tubular outer member 94mif desired. If this is to be done, the force applied against the trailing end portion 38mof the anchor 30mby the inner member 92mwould press the leading end portion 44mof the suture anchor against the surface 364 without deflecting the sections 370 of the suture retainer 280m. Of course, when the anchor 30mis to be positioned in body tissue, the force applied against the anchor 30mby the inner member 92mwould be increased and the sections 370 of the retainer would be deflected in the manner previously explained.

[0283] In the embodiment of the invention illustrated in FIG. 30, the tubular outer member 94mis formed of metal. The sections 370 of the anchor retainer 280mare formed by first forming the slots 372 in the outer end of a cylindrical tubular member. The sections are then deflected inward to the positions shown in FIG. 30 to form the annular retainer 280m. It should be understood that the tubular outer member 94mand the retainer 280mcould be molded as one piece of polymeric material. If this was done, it is contemplated that it may be preferred to mold the sections 370 of the retainer 280min the orientation shown in FIG. 30.

[0284] The slots 372 separate the sections 370 of the anchor retainer 280mand facilitate resilient deflection of the sections of the anchor retainer by the leading end portion 44mof the anchor. However, the number of slots 372 and sections 370 could be reduced if desired. Thus, only a single slot, or perhaps two or three slots 372, could be formed in the tubular outer member 94m. The resulting section or sections would then be plastically deformed to form the inner side surface 230mof the passage 204minto the frustrum of a cone of the suture anchor retainer 280m. As was previously mentioned, the slots 372 could be completely eliminated if desired.

[0285] Anchor Inserter Apparatus

[0286] An alternative embodiment of the anchor inserter apparatus is illustrated in FIGS. 31-37. Since the embodiment of the anchor inserter apparatus illustrated in FIGS. 31-37 is generally similar to the embodiment of the suture anchor inserter apparatus illustrated in FIGS. 1-30, similar numerals will be utilized to designate similar components, the suffix letter “n” being added to the numerals of FIGS. 31-37 to avoid confusion.

[0287] An anchor inserter apparatus 20nincludes a tubular outer member 94n(FIG. 31). The tubular outer member 94nincludes a one piece cylindrical tubular body 200n. A cylindrical passage 204nextends axially through the tubular outer member 94nbetween a circular entrance opening 206nand a circular exit opening 208n. A straight longitudinally extending slot 102nis formed in the tubular outer member 94nand extends between the entrance opening 206nand the exit opening 208n.

[0288] A handle 22nincludes a cylindrical collar 380 which extends around the tubular outer member 94n. The slot 102nextends through the collar 380. The handle 22nalso includes an outwardly extending section 382 which is manually engageable to position the tubular outer member 94nrelative to body tissue. The section 382 has a longitudinal central axis which is skewed at an acute angle to the longitudinal central axis of the tubular outer member 94nand the longitudinal central axis of the slot 102n. The longitudinal central axis of the section 382 of the handle 22nintersects the longitudinal central axis of the tubular outer member 94n.

[0289] An anchor retainer 280nis disposed adjacent to a leading end portion 242nof the tubular outer member 94n. The illustrated embodiment of the suture anchor retainer 280nincludes a projection 304nhaving the same generally hemispherical configuration as the projection 304gof FIGS. 24 and 25. The projection 304nis disposed diametrically opposite from the slot 102n. The projection 304nhas a central axis which extends perpendicular to and intersects the central axes of the passage 204nand slot 102n.

[0290] In accordance with a feature of this embodiment of the invention, two inner or pusher members are sequentially used in association with the tubular outer member 94n. Thus, an anchor positioning push rod or inner member 386 (FIG. 32) is utilized to position an anchor relative to the tubular outer member 94nand anchor retainer 280n(FIG. 31). An anchor deployment push rod or inner member 388 (FIG. 33) is subsequently utilized to push the anchor out of the tubular outer member 94n(FIG. 31). The anchor deployment push rod 388 (FIG. 33) is longer than the anchor positioning push rod 386 (FIG. 32).

[0291] The two inner members 386 and 388 (FIGS. 32 and 33) are sequentially inserted into the passage 204n(FIG. 31) after the anchor has been inserted into the passage. Thus, when the anchor 30n(FIG. 34) is to be initially positioned in the passage 204n, the anchor positioning push rod 386 is inserted into the passage 204n. A leading end surface 393 (FIG. 32) on the anchor positioning push rod 386 applies force to the trailing portion of the anchor 30m(FIG. 35) to move the anchor along the passage 204n. The anchor 30nis moved to a position in which a trailing end portion of the anchor is disposed within the passage 204nand a leading end portion of the anchor extends outwardly from the tubular outer member 94n(FIG. 36). The anchor positioning push rod 386 is then withdrawn from the passage 204n.

[0292] When the anchor 30nis to be positioned relative to body tissue, the deployment push rod 388 (FIG. 33) is inserted into the passage 204n. The anchor deployment push rod 388 is longer than the anchor positioning push rod 386. Therefore, the anchor deployment push rod 388 is effective to move the trailing end portion of the suture anchor out of the passage 204ninto body tissue.

[0293] The anchor positioning push rod or inner member 386 includes a cylindrical body 392 (FIG. 32). The body 392 has a circular end surface 393. A cylindrical stop or handle section 394 is connected with the cylindrical body 392. The stop or handle section 394 has an annular stop surface 396 which is coaxial with the cylindrical body 392 of the anchor positioning push rod or inner member.

[0294] The anchor deployment push rod 388 (FIG. 33) has a construction similar to the anchor positioning push rod 386 (FIG. 32). The anchor deployment push rod (FIG. 33) includes a cylindrical body 398. The cylindrical body 398 (FIG. 33) of the anchor deployment push rod 388 has a length which exceeds the length of the anchor positioning push rod 386 by more than the maximum depth to which an anchor is to be moved into body tissue. A cylindrical stop or handle section 400 is disposed in a coaxial relationship with the cylindrical body 398 of the anchor deployment push rod or inner member 388.

[0295] The cylindrical body 398 of the anchor deployment push rod or inner member 388 (FIG. 33) has indicia 404 which cooperates with an annular end surface 408 (FIG. 31) on the tubular outer member 94 to indicate the position of, a leading end or pusher surface 410 on the anchor deployment push rod 388 (FIG. 33) relative to the tubular outer member 94. The indicia 404 (FIG. 33) cooperates with the end surface 408 (FIG. 31) on the tubular outer member 94mto indicate the depth to which the anchor deployment push rod or inner member 388 has pushed the anchor 30n(FIG. 36) into body tissue. The inner member 92cof the embodiment of the invention illustrated in FIG. 11 could be provided with indicia corresponding to the indicia 404 if desired.

[0296] During assembly of the anchor inserter apparatus 20n, an anchor 30n(FIG. 34) is inserted into the passage 204nin the tubular outer member 94n. At this time, the suture 32nmay be connected with the suture anchor 30nand the legs 62nand 64nare aligned with and extend through the slot 102nin the tubular outer member 94n. The anchor 30nhas an outside diameter which is smaller than the inside diameter of the portion of the passage 204nahead of the suture anchor retainer 280n.

[0297] The cylindrical body 392 (FIG. 35) of the anchor positioning push rod 386 is inserted into the passage 204nin the tubular outer member 94n. The leading end surface 393 on the anchor positioning push rod 386 pushes the anchor 30ntoward the anchor retainer 280nat the leading end portion 242mof the tubular outer member 94n. The leading end portion of the anchor 30napplies force against and resiliently deflects a projection 304nin the anchor retainer 280n(FIGS. 35 and 37).

[0298] The projection 304nhas the same hemispherical configuration as the projection 304gof FIG. 24. The projection 304n(FIG. 37) is disposed opposite from the slot 102nand has a central axis which extends perpendicular to and intersects parallel central axes of the tubular outer member 94nand the slot 102n. As the projection 304nis resiliently deflected, the width of the slot 102nopposite from the projection increases.

[0299] When the anchor 30nhas been moved to a desired position relative to the anchor retainer 280n(FIG. 37), the stop surface 396 on the stop section 394 of the inner member 386 (FIG. 36) is in abutting engagement with the end surface 408 on the tubular member 94n. At this time, the anchor 30nis positioned with a leading end portion of the anchor extending outward from the tubular member 94nand with a trailing end portion of the anchor 30ndisposed in the passage 204n(FIG. 37). The anchor retainer 280nis effective to firmly grip the anchor 30nwhen the anchor is in the position shown in FIGS. 36 and 37.

[0300] The projection 304n(FIG. 37) is effective to press the anchor 30nagainst an inner side surface of the passage 204nopposite from the projection 304n. At this time, the tubular outer member 94nis deflected by force applied against the projection 304nand the inner side surface of the passage 204nby the anchor 30n. This deflection results in the width of the slot 102nbeing greater adjacent to the anchor 30nthan at the opposite end of the tubular outer member 94n.

[0301] The anchor positioning push rod 386 is then withdrawn from the passage 204nin the tubular outer member 94n. Since the anchor 30nis firmly held by the anchor retainer 280n, the anchor inserter apparatus 20ncan be moved from an assembly location to an operating room where the anchor inserter apparatus is to be utilized. The anchor deployment push rod 388 of FIG. 33 is moved to the operating room along with the tubular outer member 94nand the anchor 30n. However, the anchor positioning push rod 386 remains at the assembly location and is used to position another suture anchor relative to another tubular outer member.

[0302] At the operating room, the anchor deployment push rod 388 (FIG. 33) is inserted into the passage 204nin the tubular outer member 94n. Once the tubular outer member 94nand the suture anchor 30nhave been positioned relative to body tissue, the anchor deployment push rod 388 is pressed against the trailing end of the anchor 30nto force the anchor out of the tubular outer member 94ninto body tissue.

[0303] As the anchor deployment push rod 388 is inserted into the passage 204nin the tubular outer member 94n, the indicia 404 (FIG. 33) on the anchor deployment push rod cooperates with the end surface of the tubular outer member 94nto indicate the position of the leading end 410 of the anchor deployment push rod 388 relative to the tubular outer member 94n. Thus, the indicia 404 will indicate when the leading end 410 of the anchor deployment push rod has just moved into engagement with the trailing end of the anchor 30nwhile the anchor 30nis gripped by the anchor retainer 280n. Continued movement of the anchor deployment push rod into the passage 204nin the tubular outer member 94nmoves the indicia 404 relative to the end surface 408 on the tubular outer member 94n. When the indicia indicates that the leading end 410 of the push rod deployment member 388 has moved the desired distance into the body tissue, the orientation of the suture anchor 30nrelative to the body tissue is changed in the manner illustrated schematically in FIGS. 13-15.

[0304] In the foregoing description it has been assumed that the inner members 386 and 388 will be sequentially moved relative to the tubular outer member 94n. However, if desired, the tubular outer member 94ncould be moved relative to the inner members 386 and 388. Thus, the tubular outer member 94ncould be moved relative to the inner member 386 to position the anchor 30nin engagement with the suture anchor retainer 280n(FIG. 37). Similarly, the tubular outer member 94ncould be moved relative to the inner member 388 to separate the suture anchor 30nfrom the tubular outer member.

[0305] In the foregoing description it has been assumed that the anchor 30nwould be moved along the passage 204ninto engagement with the anchor retainer 280n. However, the anchor 30ncould be moved through the opening 208ninto engagement with the anchor retainer 280n. If the anchor 30nis moved through the opening 208ninto engagement with the suture anchor retainer 280n, the inner member 386 may be positioned in the passage 204n. The end surface 393 on the inner member 386 would then function as a stop to limit the extent of inward (leftward as viewed in FIG. 37) movement of the anchor relative to the tubular outer member 94n.

[0306] One specific anchor retainer 280nhas been illustrated in FIG. 37. The anchor retainer 280nhas the same construction as the suture anchor retainer 280gof FIGS. 24 and 25. However, it is contemplated that the anchor retainer 280nof FIG. 37 could have the same construction as anyone of the anchor retainers previously described herein.

[0307] Tubular Outer Member With Insertion Funnel

[0308] In the embodiment of the invention illustrated in FIGS. 31-37, the tubular outer member 94nhas a cylindrical configuration. In the embodiment of the invention illustrated in FIG. 38, the tubular outer member has an outwardly flaring end portion to facilitate insertion of the anchor into the tubular member. Since the embodiment of the invention illustrated in FIG. 38 is generally similar to the embodiment of the invention illustrated in FIGS. 31-37, similar numerals will utilized to designate similar components, the suffix letter “p” being associated with the numerals of FIG. 38 to avoid confusion.

[0309] An anchor insertion apparatus 20pincludes a tubular outer member 94phaving a cylindrical central passage 204p. A slot 102pextends between opposite end portions of the tubular outer member 94p. The slot 102palso extends through a collar 380pof a handle 22p. In accordance with a feature of this embodiment of the invention, an outwardly flaring end portion or funnel 420 extends outward from the entrance opening 206pto the passage 204p. The funnel 420 has a side wall 424 with a generally conical configuration. The funnel 420 tapers from a relatively large end opening 426 to the entrance opening 206p. The slot 102pextends along the side wall 424 of the funnel 420.

[0310] When an anchor is to be moved into the passage 204pin the tubular outer member 94p, the anchor is moved into the funnel 420. A suture, which may be connected with the suture anchor, extends through the portion of the slot 102pdisposed in the side wall 424 of the funnel. The anchor is moved downward (as viewed in FIG. 38) through the funnel 420 to the entrance opening 206pto the passage 204p. The funnel 420 guides this movement of the anchor and aligns the suture anchor with the passage 204p. The anchor positioning rod 386 and anchor deployment rod 388 of FIGS. 32 and 33 can be used with the anchor insertion apparatus 20pof FIG. 38.

[0311] Indexing of Inner Member

[0312] In the embodiment of the invention illustrated in FIGS. 31-37, a relatively short anchor positioning rod 386 is utilized to position an anchor relative to an anchor retainer 280n(FIGS. 36 and 37). A second inner member or deployment push rod 388 is longer than the anchor positioning push rod 386 and is used to move the anchor out of the passage 204ninto body tissue. In the embodiment of the invention illustrated in FIGS. 39 and 40, the same inner member is used to position the anchor relative to an anchor retainer and to move the anchor into body tissue. Since the embodiment of the invention illustrated in FIGS. 39 and 40 is generally similar to the embodiment of the invention illustrated in FIGS. 1-38, similar numerals will be utilized to designate similar components, the suffix letter “r” being associated with the numerals of FIGS. 39 and 40 to avoid confusion.

[0313] A anchor inserter apparatus 260rincludes a cylindrical inner member 92rand a cylindrical tubular outer member 94r. The outer member 94rhas the same construction as the outer member 94nof FIG. 31. The outer member 94rhas a slot 102rwhich extends between the circular entrance opening 206rand an exit opening (not shown) corresponding to the exit opening 208nof FIG. 31.

[0314] A handle 22ris connected with the end portion of the tubular outer member 94radjacent to the entrance opening 206r. An anchor retainer (not shown) is disposed adjacent to the exit opening from the tubular outer member 94r. The anchor retainer connected with the tubular outer member 94rhas the same construction as illustrated in FIGS. 24, 25, 31 and 37.

[0315] In accordance with a feature of the embodiment of the invention illustrated in FIGS. 39 and 40, a stop or index pin 430 is connected with the inner member 92r. When the inner member 92rhas moved an anchor to a predetermined position relative to an anchor retainer connected with the tubular outer member 94r, in the manner illustrated in FIG. 37 for the anchor 30n, the stop member 430 engages an annular end or stop surface 408ron the tubular outer member 94r(FIG. 39). At this time, the leading end of the inner member 92ris disposed adjacent to an anchor retainer (not shown) connected with the outer end portion of the tubular outer member 94rto position the anchor for engagement by the anchor retainer.

[0316] In the embodiment of the invention illustrated in FIGS. 39 and 40, the anchor retainer has the same construction as the anchor retainer 280nof FIG. 37. However, it is contemplated that the anchor retainer could have a construction which is the same as the construction of any one of the anchor retainers illustrated in FIGS. 19-30. Engagement of the stop member 430 with the end surface 408ron the tubular outer member 94rlimits telescopic movement of the inner member 92rrelative to the tubular outer member 94r. Therefore, the anchor is positioned with a leading end portion of the anchor extending from the tubular outer member 94rand a trailing end portion of the anchor disposed in a passage 204rformed in the tubular outer member 94r. At this time, the trailing end portion of the anchor is gripped by the anchor retainer.

[0317] When the anchor is to be positioned relative to body tissue, the inner member 92ris rotated about its longitudinal central axis relative to the tubular outer member 94r, in the manner indicated schematically by an arrow 434 in FIG. 39. As the inner member 92rrotates about the longitudinal central axis of the passage 204r, the stop member 430 is moved into alignment with the slot 102rin the tubular outer member 94r.

[0318] To disengage the anchor from the anchor retainer and to move the trailing end portion of the anchor from the passage 204rinto body tissue, the inner member 92ris moved along coincident longitudinal central axes of the inner member and the outer member 94r. As this occurs, the stop member 430 moves into the slot 102r(FIG. 40). As the stop member 430 moves along the slot 102r, the inner member 92rapplies force against the trailing end portion of the anchor to move the anchor out of the tubular outer member 94rin the manner previously explained in conjunction with the embodiments of the invention illustrated in FIGS. 11-37.

[0319] As the inner member 92ris telescopically moved into the outer member 94r, indicia 404rcooperates with the end surface 408r(FIG. 40) to indicate the position of the leading end of the inner member 92rand the anchor relative to the leading end of the outer member 94r. When the indicia 404rindicates that the inner member 92rand anchor have been moved through a desired distance relative to the outer member 94r, the orientation of the anchor is changed relative to the body tissue in the manner illustrated schematically in FIGS. 13-15 for the suture anchor 30c.

[0320] Index Recess

[0321] In the embodiment of the invention illustrated in FIGS. 39 and 40, the stop member 430 is moved along the slot 102rwhich extends between opposite ends of the tubular outer member 94r. In the embodiment of the invention illustrated in FIG. 41, an index recess is provided to receive the stop member. Since the embodiment of the invention illustrated in FIG. 41 is generally similar to the embodiment of the invention illustrated in FIGS. 39 and 40, similar numerals will be utilized to designate similar components, the suffix letter “s” being associated with the numerals of FIG. 41 to avoid confusion.

[0322] A cylindrical inner member 92sis telescopically received in a passage 204sformed in a cylindrical tubular outer member 94s. A handle 22sis connected with the tubular outer member 94s. The inner member 92sis movable axially along the passage 204sin the tubular outer member 94suntil a cylindrical stop member 430sengages an annular stop surface 408son the tubular outer member 94s.

[0323] Engagement of the stop member 430swith the stop surface 408soccurs when the suture anchor has been moved to a position relative to the tubular outer member 94sin which a leading end portion of the suture anchor extends outward from the tubular outer member and a trailing end portion of the suture anchor is disposed in the passage 204s. At this time, an anchor retainer having a construction similar to the construction of any one of the suture retainers illustrated in FIGS. 19-28 engages the anchor to hold it in a predetermined position relative to the tubular outer member 94s. It is believed that it may be desired to utilize an anchor retainer having the same construction as the suture anchor retainer 280nof FIGS. 31 and 37.

[0324] In accordance with a feature of the embodiment of the invention illustrated in FIG. 41, an index recess 440 is provided in the tubular outer member 94sto receive the stop member 430. The index recess 440 is provided with a plurality of index surfaces 442, 444, and 446 which correspond to different depths of insertion of an anchor into body tissue. Thus, when the anchor is to be inserted a relatively short distance into the body tissue, the stop member 430sis moved into engagement with the index surface 442 to limit relative movement of the inner member 92srelative to the tubular outer member 94s. If the anchor is to be inserted further into the body tissue, the stop member 430sis moved into engagement with the index surface 444. If the anchor is to be inserted still further into the body tissue, the stop member 430sis moved into engagement with the index surface 446.

[0325] The index recess 440 enables the stop member 430sto move to a desired position relative to the tubular outer member 94swithout moving along the slot 102sformed in the tubular outer member 94s. In addition, the index recess 440 enables the depth of insertion of an anchor into body tissue to be controlled by engagement of the stop member 430swith any one of the index surfaces 442, 444 or 446.

[0326] In the illustrated embodiment of the invention, the index surfaces 442, 444 and 446 are disposed in a single index recess. However, the index surfaces 442, 444 and 446 could be disposed in a plurality of index recesses. Thus, a plurality of different length slots could be formed in the tubular outer member 94swith a different index surface at the end of each slot.

[0327] Deflectable Stop Member

[0328] In the embodiment of the invention illustrated in FIGS. 39-41, a stop member 430ror 430sis fixedly connected with an inner member. In the embodiment of the invention illustrated in FIG. 42, a stop member is yieldable relative to the inner member. Since the embodiment of the invention illustrated in FIG. 42 is generally similar to the embodiment of the invention illustrated in FIGS. 1-41, similar numerals will be utilized to designate similar components, the suffix letter “s” being associated with the numerals of FIG. 42 to avoid confusion.

[0329] A generally cylindrical inner member 92tis received in a passage 204tformed in a cylindrical tubular outer member 94t. A handle 22tis connected with the tubular outer member 94t. A slot 102textends between openings at opposite ends of the tubular outer member 94t. An anchor retainer (not shown) is disposed adjacent to the leading end of the tubular outer member 94t.

[0330] In accordance with a feature of the embodiment of the invention illustrated in FIG. 42, a resiliently deflectable stop 450 is connected with the inner member 92t. The stop 450 is engageable with the entrance opening 206tto limit axial movement of the inner member 92trelative to the outer member 94tin the manner illustrated in FIG. 42. The stop 450 is formed of a resiliently deflectable material which, when axial force is applied against the inner member 92t, is deflected radially inward and enters the passage 204tin the tubular outer member 92t. As this occurs, the inner member 92tmoves the suture anchor out of engagement with a suture anchor retainer (not shown) and into body tissue.

[0331] Suitable indicia 404tis provided on the inner member 92t. The indicia 404tcooperates with an end surface 408ton the tubular outer member 94tto indicate the position of the inner member 92trelative to the tubular outer member 94tand the body tissue.

[0332] Forming of Opening in Body Tissue

[0333] When the anchor is to be positioned in hard body tissue, in a manner similar to that illustrated in FIGS. 13-15, a recess or opening is formed in the hard body tissue to receive the suture anchor. Since components of the embodiment of the invention illustrated in FIG. 43 are the same as components of the embodiments of the invention illustrated in FIGS. 1-42, similar numerals will be utilized to identify similar components, the suffix letter “u” being added to the numerals of FIG. 43 to avoid confusion.

[0334] In accordance with a feature of the embodiment of the invention illustrated in FIG. 43, the tubular outer member 94uis used to guide movement of a cutting tool, such as a drill 460 relative, to hard body tissue or bone 252u. Thus, the tubular outer member 94uis used for the purpose of guiding movement of the cutting tool. The tubular outer member 94uis also used to guide movement of an inner member and anchor, such as the inner member 92cand anchor 30cof FIG. 11.

[0335] When a recess or opening, corresponding to the opening 250 of FIG. 13, is to be formed in the bone 252u(FIG. 43), a thin elongated member 464 is rotated about its central axis, in the manner indicated schematically by an arrow 466 in FIG. 43, by a suitable drill mechanism. As this occurs, the thin elongated member or K-wire 464 is moved axially into the bone. After the thin elongated member 464 has been moved to a desired depth into the bone, the tubular outer member 94uof an anchor inserter apparatus having the same construction as the anchor inserter apparatus 20cof FIG. 11, is axially positioned around the thin elongated member 464.

[0336] The drill 460 has a central passage 470 which enables the drill to be slid onto the thin elongated member 464. The tubular outer member 94tis then positioned around the drill and moved into engagement with the bone 252uin the manner illustrated in FIG. 43. The drill 460 is then rotated about the coincident longitudinal central axes of the thin elongated member 464 and the tubular outer member 94uin the manner indicated schematically by an arrow 472 in FIG. 43.

[0337] As the drill is rotated, in the manner indicated by the arrow 472 in FIG. 43, the drill is moved axially relative to the stationary thin elongated member 464 and to the stationary tubular outer member 94. This axial movement of the drill slides the drill along the cylindrical outer side surface of the thin elongated member 464 and along an inner side surface 230uof the tubular outer member. As this occurs, the drill forms an opening in the bone 252.

[0338] Indicia (not shown) may be provided on the drill. This indicia cooperates with the end of the tubular outer member 94uto indicate the depth to which the drill has moved into the bone 252u. The indicia on the drill cooperates with an end surface (not shown) on the tubular outer member 94uin the same manner as in which the indicia 404 (FIG. 33) on the inner member 388 cooperates with the end surface 408 on the tubular outer member. If desired, a stop could be connected with the drill 460 (FIG. 43) and moved into engagement with the end surface on the tubular outer member to limit axial movement of the drill into the bone 252.

[0339] When the drill 460 (FIG. 43) has moved to a desired depth in the bone 252u, the drill is axially withdrawn from the thin elongated member. The thin elongated member extends further into the bone 252uthan the distance which the drill enters the bone. Therefore, the thin elongated member 464 remains in place as the drill 460 is withdrawn from the thin elongated member.

[0340] The tubular outer member 94tis maintained stationary relative to the bone 252uas the drill 460 is withdrawn from the thin elongated member. The orientation of both the thin elongated member 464 and the tubular outer member 94tare maintained constant relative to the bone 252uafter the drill has been withdrawn from the passage 204uin the tubular outer member 94u. The tubular outer member 94umay be held stationary relative to the bone 252uby clamping the portion of the patient containing the bone to a base plate and by fixedly connecting the tubular outer member 94twith the base plate.

[0341] Once the opening has been drilled to the desired depth in the bone 252tand the drill 460 disengaged from the thin elongated member 464 and tubular outer member 94t, the anchor is moved along the thin elongated member 464 into the tubular outer member 94t. This results in the anchor being guided into the opening formed in the bone 252uby the thin elongated member. The anchor is moved into the opening formed in the bone by movement of a tubular inner member, corresponding to the inner member 92cof FIG. 11, axially along the thin elongated member and into the tubular outer member 94.

[0342] The present invention relates to a new and improved method and apparatus 20 (FIGS. 1-43) for use in positioning an anchor 30 during assembly of the apparatus. The invention also relates to a new and improved apparatus 20 (FIGS. 1-43) for use in positioning an anchor 30 relative to body tissue during use of the apparatus. The apparatus 20 includes a tubular outer member 94 and an inner member 2 which is received in a passage 204 in the tubular outer member.

[0343] A slot 102 may extend between openings 206 and 208 at opposite ends of the tubular outer member 94. During positioning of the anchor 30 relative to body tissue 88 or 252, the slot 102 facilitates visualization of the anchor by a surgeon. Stop surfaces 396, 410, and 430 may be provided in association with the inner and outer members 92 and 94 to facilitate moving the anchor 30 to a desired position relative to the inner and outer members during relative movement between the inner and outer members.

[0344] In addition, the apparatus 20 may includes a retainer 280 which holds an anchor 30 in a desired position relative to the apparatus during assembly of the apparatus and during positioning of the anchor relative to body tissue. The retainer 280 is deflected under the influence of force applied against the retainer by the anchor 30 to enable the retainer to grip the anchor and hold the suture anchor in the desired position.

[0345] The retainer 280 may engage a recess 300, 236, or 238 in the anchor 30. The recess may be formed by a passage in the anchor. Alternatively, the recess may be formed in an outer side surface of the anchor.

[0346] During positioning of the anchor 30 relative to body tissue 88 or 252, the tubular outer member 94 may be utilized as a guide for a drill 460 which forms an opening in the body tissue. After the opening has been formed in the body tissue, the drill 460 is removed from the tubular outer member 94 and the anchor 30 is moved along the tubular outer member 94 into the body tissue.