Clip applying apparatus and ligation clip

[0001] This application claims priority from U.S. Provisional Application Ser. No. 60/612,620, filed Sep. 23, 2004, the contents of which are incorporated herein by reference in its entirety.

[0002] 1. Technical Field

[0003] The present disclosure relates to clip applying apparatus and ligation clips. More particularly, the present disclosure relates to a clip applying apparatus for applying surgical clips to body tissue during surgical procedures.

[0004] 2. Background to Related Art

[0005] Surgical procedures frequently require ligation of blood vessels, severed tissues and/or other organs to control or stop bleeding. Clip applying apparatus for quickly applying a surgical clip about tissue are well known. Such clip applying apparatus include single clip applicators and multiple clip applicators. In single clip applicators, a new clip must be loaded into the apparatus after application of each clip. Multiple clip applicators include a series of clips which can be sequentially applied to tissue during the course of a surgical procedure. Because surgical procedures usually require the use of a multiplicity of surgical clips, multiple clip applicators are generally preferred.

[0006] Typically, clip applying apparatus include a handle mechanism, an elongated body portion, and a clip crimping assembly, e.g., a jaw or pair of jaws. Such clip applying apparatus are configured for endoscopic or open surgical procedures. One problem associated with known clip applying apparatus is obstructed visualization of the surgical site especially during endoscopic surgical procedures. A continuing need exists for a clip applying apparatus which provides improved visibility of the surgical site during application of a surgical clip to tissue or vessels.

[0007] The presently disclosed clip applying apparatus includes a handle assembly, a central body portion extending distally from the handle assembly, an anvil jaw supported on a distal end of the central body portion and configured to engage a clip, a slide member movably supported in relation to the anvil jaw from a first position to a second position, and a pusher operably associated with the handle assembly. The pusher is movable from a retracted position to an advanced position to deform a clip against the anvil jaw. The anvil jaw and the slide member are configured to define an enclosed tissue receiving area when the slide member is in its second position. In one embodiment, the anvil jaw includes a linear portion and a curved distal portion and the slide member has a distally extending finger which is substantially parallel to the linear portion of the anvil jaw. The distal end of the finger is movable from a position spaced from the curved distal portion of the anvil jaw to a position adjacent the curved distal portion of the anvil jaw to define the enclosed tissue receiving area. The enclosed tissue receiving area can be substantially oval.

[0008] In one embodiment, the anvil jaw includes a proximal body portion and the slide member includes a cutout portion. The proximal body portion is slidably positioned within the cutout portion in relation to the anvil jaw.

[0009] In another embodiment, the central body portion includes an outer housing and the anvil jaw is fixedly secured to a distal end of the outer housing. A biasing member is positioned to urge the slide member toward its second position. The pusher is operably associated with the slide member such that movement of the pusher to its retracted position effects movement of the slide member to its first position. The pusher can include an elongated slot and the slide member can include a tab positioned within the elongated slot such that a distal wall defining the elongated slot engages the tab during retraction of the pusher to effect movement of the slide member from its first position to its second position.

[0010] The clip applying apparatus can also include a clip advancement mechanism and a clip track housing a series of clips. In one embodiment, the clip advancement mechanism has a clip follower positioned to engage the proximal-most clip of the series of clips and the clip advancement mechanism includes a slidable rack and a biasing member positioned between the clip follower and the slidable rack. The slideable rack includes a tab member for releasably engaging the pusher such that when the pusher is moved towards its advanced position, the tab member engages the pusher to move the slidable rack in relation to the clip follower to apply tension to the biasing member and urge the clip follower distally. In this embodiment, when the pusher is in its retracted position, the biasing member of the clip advancement mechanism is not in tension and the clip follower is not urged distally.

[0011] In one embodiment, the clip track defines a distally located window dimensioned to allow passage of the distal-most clip and the apparatus includes a retaining spring. The retaining spring is positioned adjacent a distal end of the clip track in a position to urge a distal-most clip of the series of clips from the clip track through the distally located window.

[0012] The clip applying apparatus includes at least one clip having a backspan and a pair of spaced legs. In one embodiment, the backspan is curved and each of the spaced legs includes an inwardly curved tip.

[0013] In another embodiment, the distal end of the pusher includes a rounded surface positioned to engage the backspan of a distal-most clip of a series of clips to deform the spaced legs along the curved distal portion of the anvil jaw and subsequently collapse the at least one clip into a substantially C-shaped configuration. The distal end of the pusher can include a notch which positioned to engage the backspan of the clip.

[0014] The present disclosure also provides a method for applying clip about tissue including the steps of a) providing a clip applying apparatus including at least one clip, an anvil jaw and a slide member movably supported in relation to the anvil jaw between an advanced position and a retracted position, the anvil jaw and the slide member being configured to define an enclosed tissue receiving area when the slide member is in its advanced position; b) positioning the slide member in its retracted position; c) positioning tissue to be ligated adjacent a surface of the anvil jaw; d) moving the slide member to its advanced position to capture tissue within the enclosed tissue receiving area; and e) actuating the clip applying apparatus to deform the at least one clip about the tissue to be ligated.

[0059] Embodiments of the presently disclosed clip applying apparatus and clip will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views.

[0060] FIG. 1 illustrates one embodiment of the presently disclosed clip applying apparatus 10. Briefly, clip applying apparatus 10 includes a handle assembly 12 including a stationary handle 12a and a pivotable trigger 12b, a central body portion 14 and a jaw mechanism 16. Although handle assembly 12 is illustrated having a pistol grip configuration, other known handle trigger configurations are envisioned, e.g., in-line handle, scissors handle, tweezers handle, multiple triggers, etc. A rotatable knob 18 is rotatably supported on a distal end of handle assembly 12. Rotatable knob 18 supports the proximal end of central body portion 14 in a known manner such that rotatable knob 18, central body portion 14 and jaw mechanism 16 are rotatable in relation to handle assembly 12 about the longitudinal axis of central body portion 14. It is envisioned that rotatable knob 18 may be configured to rotate the jaw mechanism 16 while the central body portion 14 remains stationary. Although specific details of the handle assembly 12 are not disclosed herein, the handle assembly 12 may include any suitable handle mechanism known in the art to effect actuation of a clip pusher mechanism as will be described in detail below. Examples of such known handle mechanisms 12 are disclosed in U.S. Pat. Nos. 5,938,667, 5,868,761, 5,868,759, 5,725,538, 5,720,756, 5,700,270, 5,695,502, 5,645,553, 5,626,585, 5,591,178, 5,514,149, 5,462,558, 5,300,081, 5,197,970 and 4,509,518 which are all incorporated herein in their entirety by reference.

[0061] Referring to FIGS. 1 and 2, central body portion 14 of clip applying apparatus 10 includes an outer housing 20 which encloses the internal components of central body portion 14. Anvil body 22 is fixedly secured within the distal end of housing 20 using known fastening techniques, e.g., crimping, pins, adhesives, etc. In one embodiment, anvil jaw 24 extends distally from anvil body 22 and includes a linear portion 24a and a semi-circular or curved portion 24b to define a substantially J-shape. Anvil jaw 24 includes a channel 24c for slidably receiving and guiding movement and formation of a clip along anvil jaw 24 as explained in more detail below. (See also FIG. 5 for an enlarged view of the anvil body and jaw).

[0062] The internal components of central body portion 14 include an enclosure or slide member 26 which is slidably positioned within housing 20, a pusher 28 for advancing and crimping a distal-most clip 76b from a series of clips, a clip advancement mechanism 30 for distally advancing the series of clips towards anvil jaw 24, and a clip track 32 for guiding and, in association with clip advancement mechanism 30, permitting advancement of the series of clips. More particularly, pusher 28 includes a proximal end operatively connected to handle assembly 12 (not shown) in a known manner. Pusher 28 is slidably positioned within housing 20 such that when pivotable trigger 12b is moved through an actuating stroke, i.e., compressed towards stationary handle 12a, pusher 28 is advanced from a retracted position (See FIG. 19) to an advanced position (See FIG. 25). Pusher 28 includes a plurality of longitudinally spaced channels 34 and a distally-located longitudinal slot 36. Channels 34 and slot 36 are positioned and configured to engage tabs on slide member 26 and on clip advancement mechanism 30, as will be described in further detail below, to control movement of slide member 26 and clip advancement mechanism 30 during movement of pusher 28 from its retracted position to its advanced position.

[0063] Referring also to FIG. 3, slide member 26 includes an elongated body 40 which is slidably positioned within housing 20. Elongated body 40 includes a semi-circular proximal portion 42, a semi-annular cutout portion 44 and a head portion 46 including a distally extending finger 46a. Finger 46a includes a channel 46b for slidably receiving and guiding a clip 76 into anvil jaw 24. Cutout portion 44 is dimensioned to receive anvil body 22 therein. The length of cutout portion 44 is greater than the length of anvil body 22 to permit slide member 26 to slide axially in relation to anvil body 22 between advanced and retracted positions.

[0064] An elongated projection 46c is formed on head portion 46. Projection 46c is slidably received within a slot 50 formed in the distal end of housing 20 to maintain alignment between head portion 46 of slide member 26 and anvil jaw 24 (See FIG. 2). Referring also to FIGS. 3A and 3B, the distal end of slide member 26 has an elongated cavity 52 formed along one side of cutout portion 44 which is dimensioned to receive a biasing member 54, e.g., a coil spring (See FIG. 2). Biasing member 54 is supported in compression within cavity 52 and includes a proximal end engaging an abutment 55 (See FIG. 2) formed on an inner surface of anvil body 22 and a distal end engaging a rear face 46d of head portion 46. Biasing member 54 urges slide member 26 toward its advanced position in which finger 46a engages the distal end of curved portion 24b of anvil jaw 24 to define an enclosed tissue receiving area 25 (See FIG. 3C and FIGS. 8-11). In one embodiment, finger 46a is substantially parallel to linear portion 24a of anvil jaw 24 and tissue receiving area 25 is substantially oval. A tab 56 (See FIG. 2) is formed on slide member 26 and is positioned to be received in slot 36 and distalmost channel 34 of pusher 28. When pusher 28 is being moved to its retracted position, the distal end or wall 36a defining pusher slot 36 engages the forward end of tab 56 to move slide member 26 from its advanced position to its retracted position against the bias of baising member 54. A clip channel or slot 60 (See FIG. 3B) is formed through head portion 46 of slide member 26 to allow passage of the clips 76 into anvil jaw 24. The proximal end of slot 60 is accessible from cutout portion 44.

[0065] Central body portion 14 of clip applying apparatus 10 also includes the clip advancement mechanism 30 and a clip track 32. Clip advancement mechanism 30 includes a clip follower 62, a slidable rack 64 and biasing member 66, e.g., a coil spring. Referring also to FIGS. 3E and 3F, slidable rack 64 defines a C-shaped channel 68 dimensioned to slidably receive clip follower 62 and includes a resilient tab 70 which is dimensioned and configured to be received within channels 34 of pusher 28. A finger 64a formed on slidable rack 64 extends into an elongated slot 62a formed in clip follower 62 to maintain rack 64 and follower 62 in alignment. A spring engagement member 72 is formed at the distal end of slidable rack 64. A distal end of biasing member 66 is secured to engagement member 72 of slidable rack 64.

[0066] Clip follower 62 includes a concave or curved distal end 74 configured to engage a backspan of the proximal-most clip 76a of a series of clips 76. A resilient tab 78 is formed at the proximal end of clip follower 62. Tab 78 is configured to be received within recesses or openings 80 formed in clip track 32 to prevent proximal movement of follower 62 in relation to clip track 32 (See FIG. 35). Because of the angle of tab 78, distal movement of follower 62 in relation to clip track 32 is permitted. A spring engagement member 82 is formed on clip follower 62. The proximal end of biasing member 66 is secured to engagement member 82. Biasing member 66 is supported in tension between slidable rack 64 and clip follower 62 to facilitate incremental advancement of the series of clips 76 in a manner to be described in further detail below.

[0067] Referring to FIG. 2 and FIGS. 3G-3I, clip track 32 also defines a C-shaped channel 84 dimensioned to slidably receive the series of clips 76 and clip advancement mechanism 30. The series of clips 76 is positioned in the distal end of C-shaped channel 84 and the clip advancement mechanism 30 is positioned in the proximal end of C-shaped channel 84 with clip follower 62 engaging the proximal-most clip 76a of the series of clips 76. As discussed above, clip track 32 includes a series of longitudinally spaced openings 80. Each opening 80 is dimensioned to receive resilient tab 78 of clip follower 62 to prevent proximal movement of clip follower 62 in relation to clip track 32 (FIG. 3J). The distal end of C-shaped channel 84 includes a window or opening 86 (FIG. 3G) which allows a clip to exit C-shaped channel 84 to a position distally of the distal end of pusher 28. A retaining spring 88 (FIG. 2) is secured to the distal end of clip track 32 adjacent window 86 to urge the distal-most clip 76b from C-shaped channel 84 against a sidewall 90 (FIG. 3B) within cutout 44 of slide member 26 adjacent clip slot 60. Retaining spring 88 also functions to secure the distal-most clip 76b against sidewall 90 of cutout 44 adjacent clip slot 60 until pusher 28 is actuated via pivotable trigger 12b to apply the clip 76b to tissue. (See FIG. 18).

[0068] Referring again to FIG. 2, a clip track cover 87 is secured to a top surface of clip track 32. Cover 87 may be formed from a clear material to permit visualization of the clips remaining in the apparatus.

[0069] FIGS. 6 and 7 illustrate one embodiment of a ligating clip shown generally as 76. Ligating clip 76 includes a backspan 102 and a pair of legs 104. Backspan 102 may be curved or semi-circular. Alternately, other configurations are envisioned. Each leg 104 is substantially parallel to the other leg and may include a curved tip 106 which curves generally towards the other of the clip legs. Curved tips 106 allow the legs to smoothly traverse curved channel 24c of anvil jaw 24 without binding within the jaw during deformation of the clip 76. In a particularly useful embodiment, clip 76 is constructed from a surgical grade metal such as titanium. Alternately, other materials suitable for surgical use and having the requisite strength and deformation characteristics may be used to construct the clip 76.

[0070] Referring to FIGS. 2 and 19-21, prior to actuation of clip applying apparatus 10, pusher 28 is maintained in its retracted position in a known manner by handle assembly 12. In the retracted position, pusher 28 retains slide member 26 in its retracted position. More specifically, when pusher 28 is moved to the retracted position, the distal end 36a of slot 36 formed in pusher 28 engages tab 56 of slide member 26 to move slide member 26 to its retracted position with pusher 28 against the bias of biasing member 54 which is in compression (See FIG. 20). Resilient tab 78 of clip follower 62 is engaged within an opening 80 (See FIGS. 16, 17 and 21) of clip track 32 to retain clip follower 62 at a position in which the distal end 74 of clip follower 62 is engaged with the proximal-most clip 76a (See FIG. 2B). Biasing member 66 is not in tension (or compression). Thus, no substantial axial force is being applied to the series of clips 76 by clip follower 62. Slidable rack 64 is supported about clip follower 62. The distal-most clip 76b is positioned against sidewall 90 within cutout portion 44 of slider 46 adjacent clip slot 60 at a position distally of the distal end of pusher 28.

[0071] Referring to FIGS. 22-24, when pivotable trigger 12b (See FIG. 1) is actuated to distally advance pusher 28 within housing 20, slot 36 of pusher 28 is moved distally in relation to tab 56 of slide member 26 (See FIG. 23). Since the distal end 36a of slot 36 no longer retains slide member 26 in its proximal position, biasing member 54 urges slide member 26 distally with pusher 28 to its advanced position. In its advanced position, head portion 46 of slide member 26 is positioned such that finger 46a abuts the distal end of curved portion 24b to define enclosed tissue receiving area 25 (See FIG. 10).

[0072] During distal advancement of pusher 28, resilient tab 70 of slidable rack 64 is received within channel 34 of pusher 28 (See FIG. 24). When the proximal edge 70a of tab 70 engages the proximal end of channel 34, slidable rack 64 is advanced distally with pusher 28. As slidable rack 64 moves distally, biasing member 66 is put in tension to urge clip follower 62 distally. However, because pusher 28 is positioned over window 86 (See FIG. 23) of clip track 32, the series of clips 76 and thus clip follower 62, cannot advance distally. As a result, slidable rack 64 is advanced distally with pusher 28 over clip follower 62 increasing the length and the tension in biasing member 66.

[0073] At a point during advancement of pusher 28, the distal end 28a of pusher 28 engages the backspan 102 of distal-most clip 76b and advances distal-most clip 76b through clip slot 60 along anvil jaw channel 24c and channel 46b of finger 46a of head portion 46 into anvil jaw 24 (See also FIGS. 10 and 11). When pusher 28 passes distally over window 86 of clip track 32, pusher 28 covers window 86 to prevent the second distal-most clip from being pushed through window 86 by retaining spring 88. As such, series of clips 76 still cannot move distally, and clip follower 62 remains in its original position prior to actuation of clip applying apparatus 10.

[0074] Referring to FIGS. 25-27, when clip 76b is positioned within anvil jaw 24, continued advancement of pusher 28 first deforms the clip into a substantially oval configuration about tissue 96 (See FIG. 12) and thereafter, collapses one end of the clip into the inside surface of the other end of the clip to form an overlapping C-shaped deformed clip about tissue 96 (See FIGS. 13 & 14). The distal end 28a of pusher 28 includes a rounded surface or nose of reduced width to effect collapse of the oval partially deformed clip 76b onto itself. A pair of tapered diverging shoulders 94 (FIG. 32) extend between distal end 28a of pusher 28 and an outer sidewall of pusher 28. Diverging shoulders 94 urge the clip into a substantially closed C-shaped configuration during the final stage of clip formation.

[0075] After clip 76b is fully deformed about a vessel (See FIG. 15), pivotable trigger 12b (See FIG. 1) is released and pusher 28 is returned from its advanced position to its retracted position in a known manner, e.g., a retraction spring located in the handle assembly or central body portion (not shown). Referring to FIGS. 28-31, as pusher 28 moves to its retracted position, biasing member 66, which is in tension begins to return slidable rack 64 to its retracted position. When distal end of pusher 28 is retracted such that it passes over and uncovers window 86 of clip track 32, biasing member 66, which is still in tension, urges clip follower 62 distally (See FIG. 28). As such, when pusher 28 uncovers window 86, retaining spring 88 pushes the next clip of the series of clips 76 through window 86 against sidewall 90 of slide member 26 adjacent clip slot 60. After the next clip of the series of clips 76 is moved through window 86, biasing member 66 urges clip follower 62 distally to advance the series of clips 76 distally to position the second clip of series of clips 76 to a position beneath window 86 (See FIGS. 30 and 32). As clip follower 62 advances distally, resilient tab 78 (FIG. 27) of clip follower 62 disengages with the opening 80 of clip track 32 with which it was engaged and reengages with the next distally positioned opening 80′ (FIG. 31) in clip track 32. As pusher 28 continues to move to its retracted position to allow slidable rack 64 to move proximally, the tension in biasing member 66 is relieved and substantially all axial forces on the series of clips 76 by the clip follower 62 are removed.

[0076] As pusher 28 continues to move to its proximal-most position, the distal end 36a of slot 36 in pusher 28 engages tab 56 of slide member 26 and moves slide member 26 from its advanced position to its retracted position against the bias of biasing member 54 (FIG. 30). Movement of slide member 26 from its advanced position to its retracted position moves finger 46a of head portion 46 of slide member 26 proximally away from curved portion 24b of anvil jaw 24 to open jaw mechanism 16 and provide access to receiving area 25.

[0077] As best illustrated in FIGS. 30 and 32, the distal end 28a of pusher 28 may include a notch 29 which is dimensioned to partially engage the backspan 102 of clip 76. It is envisioned that notch 29 provides additional support and guides the clip 76 during the entire deformation of clip 76.

[0078] Clip applying apparatus 10 may be constructed from any suitable medical grade material including plastics and metals suitable for use in medical instrumentation. For example, the anvil body and/or jaw and other high force bearing components of the clip applying apparatus 10 may be constructed from surgical grade metals, whereas the clip follower 62 and other minimal force bearing components of the clip applying apparatus 10 may be formed from surgically approved plastics.

[0079] The benefits of the presently disclosed clip applying apparatus include improved visibility at the surgical site. Visibility is improved because the curved anvil jaw 24 is less obstructed by the distal components of the apparatus. Further, the curved or hooked anvil jaw 24 simplifies positioning of tissue within the anvil jaw 24. Moreover, the slide member (i.e., finger 46a) encloses the tissue receiving area 25 of anvil jaw 24 and prevents separation of anvil jaw 24 and tissue during manipulation and actuation of the apparatus.

[0080] Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that this disclosure is not limited to those precise embodiments and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the disclosure. All such changes and modifications are intended to be included within the scope of any appended claims.