Handle and surgical article

[0001] The present application is a continuation in part of U.S. Utility application Ser. No. 10/386,897, filed Mar. 11, 2003 and U.S. Utility application Ser. No. 10/306,179, filed Nov. 27, 2002; which '897 and '179 applications claim the benefit of U.S. Provisional Application Serial No. 60/362,806, filed Mar. 7, 2002; and U.S. Provisional Application Serial No. 60/380,797, filed May 13, 2002; and U.S. Provisional Application Serial No. 60/402,007, filed Aug. 8, 2002; and U.S. Provisional Application Serial No. 60/414,865 filed Sep. 30, 2002. The entire contents of all of the previous patent applications are herein incorporated by reference.

[0002] There are a wide variety of surgical instruments used in procedures for treating pelvic floor disorders. Needles, suture passers and ligature carriers are commonly available in surgical centers and hospitals. Examples of such surgical instruments include Stamey needles, Raz needles, and Pereyra needles. See Stamey, Endoscopic Suspension of the Vesical Neck for Urinary Incontinence in Females, Ann. Surgery, pp. 465-471, October 1980; and Pereyra, A Simplified Surgical Procedure for the Correction of Stress Incontinence in Women, West. J. Surg., Obstetrics & Gynecology, pp. 243-246, July-August 1959.

[0003] Handles used with surgical instruments for treating pelvic floor disorders vary in side and shape. U.S. Nos. 5,112,344; 5,899,909; 6,605,097 and 6,612,977 show various handles for use with surgical instruments for treating pelvic floor disorders such as incontinence. Published U.S. Pat. Application No. 2002 0099259-A1 discloses a handle for use with a needle useful in a variety of procedures, including a sling procedure for treating incontinence. Other handles are disclosed in published U.S. Pat. Application Nos. 2002 091298-A1 and 2001 0053916-A1.

[0004] Emmett needles are used in procedures for treating incontinence. An Emmet needle is depicted in Dargent et al., Pose d'un ruban sous uretral oblique par voie obturatrice dans le traitement de l'incontinence urinaire feminine, Gynecol. Obstet. Fertil 2002; 30:576-82. The Emmet needle includes a handle, a curved portion with a tip and what can be described as a short, straight portion between the curved portion and the handle. However, the needle is generally not meant to be rotated about the axis of the straight portion while it is within the body.

[0005] Some suture passers have straight and curved portions. These suture passers are typically reusable devices with a relatively sharp tip. These devices typically are cast from a relatively heavy metal, such as stainless steel, with no plastic component. As a result, a large proportion of the weight of the reusable suture passers resides in their handle portions.

[0006] In one aspect, the present invention comprises a handle for a surgical instrument having a needle with a substantially straight portion and a curved portion. The handle comprises an elongate body having a proximal end region, a distal end region, a top portion and a bottom portion. The straight portion of the needle adapted to project from a distal end of the body. The top portion has a substantially flat surface in the distal end region.

[0007] Preferably, the proximal end region is non-cylindrical with the width being greater than the height. The proximal end region preferably has generally convex surfaces. At least the top portion preferably has a surface that is sized and shaped to receive a user's thumb in the distal end region. In a preferred embodiment, the proximal end region has a maximum height that is larger than the height of any portion of the distal end region. Also preferably, the body has side portions with a plurality of grasping ribs.

[0008] In a preferred embodiment, the distal end region has a maximum width that is greater than the width of any portion of the proximal end region. This structure preferably forms fins.

[0009] The handle preferably includes a surface that is sized and shaped to receive a user's thumb. However, it is noted that different surgeons may grasp and use the surgical instrument according to individual preference and the present invention is not limited if a particular surgeon does not utilize a particular surface as a thumb rest.

[0010] The elongate body has an elongate axis, and the straight portion of the needle has an elongate axis, and the axis of the elongate body is at least parallel to the axis of the straight portion of the instrument, preferably they are coaxial.

[0011] In another aspect, the present invention comprises a handle for a surgical instrument. The surgical instrument has a needle with a substantially straight portion and a curved portion. The handle comprises a proximal end region, a distal end region, and a transition region between the proximal and distal end regions. The maximum height of the transition region is less than the maximum height of the proximal end region. The maximum width of the transition region is less than the maximum width of the proximal end region. The maximum width of the transition region is less than the maximum width of the distal end region.

[0012] In another aspect, the present invention comprises a surgical instrument for treating pelvic floor disorders. The surgical instrument comprises a metallic needle portion having a substantially straight portion and a substantially curved portion. The instrument includes a handle portion constructed at least in part from a polymeric material, the handle portion comprising a proximal end region, a distal end region, and a transition region between the proximal and distal end regions. The transition region is reduced in width relative to the proximal and distal end regions.

[0013] Preferably, the metallic needle portion has a tip portion that is at least substantially blunt and is constructed from stainless steel. Also preferably, the proximal end region has a maximum height that is greater than the maximum height of the transition region and the maximum height of the distal end region. The transition region has a maximum width that is preferably less than the maximum width of the distal region and the maximum width of the proximal region.

[0014] Preferably, the transition region has a substantially concave surface. Also preferably, the length of the proximal region is longer than the combined lengths of the transition region and distal end region. In a preferred embodiment, the distal end region comprises a pair of fins projecting from sides of the handle.

[0015] Other features and advantages of the present invention will be seen as the following description of particular embodiments progresses in conjunction with the drawings, in which:

[0016] FIG. 1 is a perspective view of a surgical instrument with a handle according to one aspect of the present invention;

[0017] FIG. 2 is a top view of the, surgical instrument of FIG. 1;

[0018] FIG. 3 is a bottom view of the surgical instrument of FIG. 1;

[0019] FIG. 4 is a right side view of the surgical instrument of FIG. 1;

[0020] FIG. 5 is a left side view of the surgical instrument of FIG. 1;

[0021] FIG. 6 is a front end view of the surgical instrument of FIG. 1;

[0022] FIG. 7 is a rear end view of the surgical instrument of FIG. 1;

[0023] FIG. 8 is a perspective view of another embodiment of surgical instrument according to the present invention;

[0024] FIG. 9 is a right side view of the instrument of FIG. 8;

[0025] FIG. 10 is left side view of the instrument of FIG. 8;

[0026] FIG. 11 is a top view of the instrument of FIG. 8;

[0027] FIG. 12 is bottom view of the instrument of FIG. 8;

[0028] FIG. 13 is a rear view of the instrument of FIG. 8; and

[0029] FIG. 14 is a front view of the instrument of FIG. 8.

[0030] The following description is meant to be illustrative only and not limiting. Other embodiments of this invention will be apparent to those of ordinary skill in the art in view of this description.

[0031] The present invention is directed to surgical instruments and more particularly handles for surgical instruments used in pelvic floor surgical procedures such as incontinence or stress urinary incontinence (SUI) in both men and women. Although the invention as disclosed herein generally refers to SUI, the surgical instruments may be used for treatment of other urological or gynecological disorders, such as prolapse (e.g. vaginal and uterine), enteroceles (e.g. of the uterus or small bowel), rectoceles, cystoceles and other disorders are also included within the scope of the present invention. The present invention is particularly suitable for use in conjunction with concomitant procedures, such as, but not limited to, procedures for addressing cystocele, rectocele, vaginal prolapse and anatomic corrections. Various pelvic floor procedures and implants for use in such procedures are disclosed in Staskin et al., U.S. patent application Ser. No. 10/423,662 filed, Apr. 25, 2003.

[0032] The handles of the present invention are particularly suitable for use with a surgical instrument (e.g. a needle) having a straight portion 2 and a curved portion 4. Such instruments are disclosed in Pelosi II, et al., New Transobturator Sling Reduces Risk of Injury, OBG Management, Pps. 17-38 (2003). In use, the curved portion of the needles are preferably passed around the inferior aspect of the ischiopubic ramus. For example, the distal end 5 of the needle may begin tissue passage with penetration of the skin (or incision) and subcutaneous tissue near the patient's obturator foramen. After moving through superficial perineal fascia, the needle may cross adductor muscles of the thigh near their pubic bone origin and below the insertion point of the adductor longus tendon. The needle may then penetrate the obturator membrane, obturator internus muscle, and periurethral endopelvic fascia. After passing the level of the white line, either over or under the puborectalis section of the levator, the distal end 5 of the needle may exit through a vaginal incision. Suitable needles are also disclosed in U.S. Pat. Application Nos. 2003 0212305-A1, 2003 0176875-A1 and 2003 0171644-A1. Preferably the curved portion 4 is helical or spiral shaped and has a tip 5. As an example, not intended to be limiting, to form a right handed helix, a bending mandrel with a groove may be used with dimensions of about 1.56 inches diameter, pitch about 1.85, and a degree of wrap to a bending pin on the mandrel of about 350 degrees. These dimensions are only an example and the present invention contemplates widely varying dimensions. These dimensions are prior to any spring back of the metal, and are believed suitable for a 17-4 stainless steel rod with a circular cross sectional diameter of 3.2 mm. The straight portion of the needle may be, for example, about 20 degrees off the axis of helix axis.

[0033] Also as an example not intended to be limiting, the overall maximum width of the finished curved portion may be about 2.15 inches and the bent portion of the needle may have an axial length of about 2 inches.

[0034] The tip 5 may be slightly sharpened or blunt. The region near the end of the tip may include an eyelet or it may include surfaces sized and shaped to engage with complementary surfaces on a connector and/or a sling assembly.

[0035] Notably, the handles and surgical instruments according to the present invention may be utilized with needles and surgical approaches that initially pass a needle tip through a vaginal incision and then through an incision generally adjacent a patient's obturator foramen. Also, the handles and surgical instruments according to the present invention may be utilized with instruments designed for a specific side of the patient's body (e.g. right or left) or with universal instruments designed for use on either side of the patient's body. Also, the handles and surgical instruments according to the present invention may be utilized with instruments designed for use by a surgeon's dominant hand (e.g. right or left handed). Additionally, the handles may be used with instruments that are initially inserted into the body in one general direction (i.e. a forward or insertion direction), and then removed from the body in a generally opposite direction (i.e. a reverse or removal direction). Alternatively, the surgical instrument may be used as a guide for a sling assembly.

[0036] The cross section of the needles may be of any suitable shape, preferably circular. The diameter of the circle is preferably less than about 4.5 mm, more preferably about 3.2 mm or less. The diameter of the needle may be substantially uniform along its length or it may vary. For example, the diameter may be increased at positions of greater stress or rotational bending moment, to increase the resistance of the needle to bending during use.

[0037] The tip region 5 preferably includes a reduced diameter portion, but a slightly enlarged portion with an eyelet is also within the scope of the present invention. The tip region optionally has structure for associating the instrument with another surgical article (e.g. a connector, dilator, sling assembly, sling, insertion sleeve or suture). Optionally, the tip region may incorporate specially designed surfaces for cooperating with complementary surfaces on another surgical article, such as the structures described in U.S. Pat. No. 6,641,525 or U.S. Pat. Application Publication No. 2002/0099259, published Jul. 25, 2002 (U.S. patent application Ser. No. 09/917,445, filed Jul. 27, 2001), or U.S. Pat. Application Publication No. 2002/0147382 published Oct. 10, 2002. In an alternative embodiment, an eyelet may be provided in the distal tip region.

[0038] A variety of different materials may be used to construct the straight 2 and curved portions 4 of the surgical instrument including, but not limited to medical grade plastics and metals. The straight 2 and curved portions 4 are preferably constructed from a metal. Suitable materials include titanium, stainless steel, other medical grade alloys. Suitable stainless steels include AISI types 316, 3161, 17-4 (e.g. PH H900), 302, 303 and 304.

[0039] Referring now to FIGS. 1-7, there is shown a preferred embodiment of handle 10 according to the present invention.

[0040] The handle 10 has an elongate body with a proximal end region 12 having a width W, height H and a proximal end 11. The body also has a distal end region 14 with a width W, height H and a distal end 15, a top portion 22 and a bottom portion 24.

[0041] Preferably, the straight portion 2 of the needle projects from the distal end 15 of the body 10, preferably along its longitudinal axis A. Also preferably, the axis A of the elongate body of the handle 10 is substantially coaxial with the axis A of the straight portion 2 of the needle. A user of the needle may manually place a moment about the axis A of the needle in a convenient fashion. The handle is particularly suitable for affording passage of the distal end 5 of the needle with a natural wrist rotation. As a result, the position of the tip 5 of the needle may be conveniently controlled. As can be seen by comparing FIGS. 4 and 5, the body 10 is preferably substantially symmetrical about the axis A.

[0042] The top portion of the handle has a substantially flat surface 26 in the distal end region 14. The tip 5 of the needle may be required to move very short, substantially straight distances in a controlled manner. For example, the tip 5 may need to traverse a certain type of relatively tough tissue (e.g. the obturator foramen) in a substantially short, linear path just prior to moving along a more complex path. This initial motion is substantially linear and a relatively short distance of the overall intended path for the tip.

[0043] The bottom portion 24 also preferably has a substantially flat surface in the distal end region 14. The substantially flat surface on the bottom surface 24 (opposite surface 26) is preferably sized and shaped to exploit forces applied to the handle 10 by a user's thenar muscles. The thenar muscle of the thumb is one of the few power producing muscles in the hand. See Salvendy, Handbook of Human Factors and Ergonomics, Second Edition, John Wiley & Sons, Inc. (1997). The handle 10 is preferably sized and shaped to exploit the use of this muscle, for example, during the surgeon's wrist rotation. Notably, other surgeons may use the flat surfaces 26 (and flat surface opposite surface 26, on the bottom 24 of the body 10) for other purposes. The actual grasping of the handle by a particular surgeon is dictated by a variety of factors such as surgeon training, comfort, dexterity, strength, etc.

[0044] The distal end region preferably has relatively or substantially flat fins. The distal end region 14 has a maximum width W that is preferably greater than the width W of any portion of the proximal end region 12. This conveniently allows a user to place a thumb underneath a fin (e.g. on the bottom surface 24 of the handle 10), to rotate the handle about the axis A and place a moment about the axis A of the straight portion 2 of the instrument. This affords a convenient, controlled movement of the tip 5 of the instrument along its complex (i.e. non-linear) path. As an example of a preferred embodiment of the present invention, the maximum width W may be between about 0.8 and 1.4 inches, more preferably about 1.2 inches. The maximum width W may be between about 0.7 and 1.3 inches, more preferably about 1.1 inches.

[0045] At least the top surface of the proximal end region 12 is preferably at least slightly convex. Preferably, the proximal end region 12 is non-cylindrical. Also preferably, the maximum width of the proximal end region 12 is preferably greater than its maximum height. The proximal end region 12 has a maximum height H that is preferably larger than the height H of any portion of the distal end region 14. The proximal end region affords a convenient secure grasp in the palm of a user's hand. This convenient grip is believed to afford efficient power transmission to the tip 5, especially during rotation of the body 10. As an example of a preferred embodiment of the present invention, the maximum height H may be between about 0.5 and 1.5 inches, more preferably about 0.7 to 1 inches, more preferably about 0.81 inches. The maximum height H may be between about 0.25 and 0.65 inches, more preferably about 0.44 inches

[0046] There may optionally be a transition region between the proximal 12 and distal 14 regions, as shown in FIGS. 2-5. The transition region may be reduced in size (e.g. width) relative to the proximal and distal regions. The overall length of the body 10 may be between 3 and 7 inches. In one embodiment, the length is about five inches. This size of handle is preferred with a needle that has a straight portion length of about 2 inches as measured from the end 15 of the body 10 to the beginning of the curved portion 4. The length of the proximal region 12 is preferably greater than the length the distal region 14 or the transition region.

[0047] The body has side portions 34 and 36. The surfaces of the side portions 34 and 36 are preferably substantially concave shaped in the transition region.

[0048] Referring to FIGS. 1, 5 and 6, the side surfaces 34 and 36 preferably have a plurality of tactile surfaces 35 extending in a direction substantially perpendicular to the longitudinal axis A of the handle 10. Preferably, there are at least eight tactile surfaces 35 on each side 34 and 36. In a preferred embodiment, substantially all of the surfaces 35 are located on the mid and distal regions of the handle 10. The tactile surfaces may extend above the major surfaces of the handle 10, or below the major surface. They may comprise slits, slots, bumps, embossed portions, protrusions, surface treatments, ridges, ribs, grooves or the like. Optionally, the handle 10 may have such structures on any portion thereof to enhance a user's grasp.

[0049] The tactile surfaces 35 are believed to reduce the exertion required to adequately grasp the handle 10 during needle passage through tissue. The tactile surfaces increase the friction between the handle 10 and the user's hand, which stabilizes the instrument in the user's hand. This can lead to a reduction in the rotational motion of the instrument (e.g. rotational slippage) when the tip 5 is intended to move in a short, linear motion (e.g. when the tip punctures relatively tough tissue). This is also believed to provide leverage to afford convenient, efficient power transmission when it is desired to create a moment about the axis A.

[0050] If the surgical instrument is designed for use on a particular side of a patient (e.g. the patient's right side or left side), then the handle 10 may conveniently have indicia 31. The indicia may be provided by a raised or embossed portion of the handle 10, or it may be printed on the handle. The indicia 31 is shown in this embodiment as a carrot shaped embossed portion of the handle 10. The carrot may be used to indicate on which side of the patient (relative to the patient's midline) the needle is intended to be used when the indicia is facing the user. Notably, other than the indicia 31, a handle for use with a needle for the patient's right side may be substantially identical to a handle for use with a needle designed for the patient's left side. This affords convenience in manufacturing, storing and shipping of the product.

[0051] As discussed above, a transition region is preferably present between the proximal region 12 and the distal region 14 of the handle 10. The transition region may comprise a groove or a scalloped shaped region. Conveniently, this structure may cradle the anatomical structure of a user's thumb.

[0052] The surface 29 may be ski-sloped shape and is preferably substantially symmetrical about axis A. A surface similar to surface 29 is preferably found on the bottom 24 of the handle 10.

[0053] The materials of the handle 10 can comprise any suitable material for a surgical instrument. They are preferably polymeric materials such as, but not limited to polycarbonate, polyethylene, polypropylene, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), delrin, ABS, polyurethane, nylon, acetal, urethane, polyetherimide, polysulfone or other similar sterilizable materials, including combinations thereof. Notably, a surgical instrument with a metal needle and a handle that has substantial polymeric portions will have less weight concentration in its handle compared with a fully metallic instrument in the same shape. It is believed that a surgical instrument with a handle that has substantial polymeric portions may have desirable handling characteristics.

[0054] The handle 10 preferably is permanently affixed to the needle of the surgical instrument. By permanently affixed, it is meant that the handle does not move relative to the needle (e.g. it is not manually repositionable or removable).

[0055] Molding, casting and machining processes may be utilized to construct the surgical instrument according to the present invention. The major surfaces of the handle 10 may comprise a monolithic, unitary or composite injection molded components.

[0056] The surgical instrument may be constructed using a molding process. First, case halves may be molded out of a suitable material (e.g. a polycarbonate). Next, the needle portions 2 and 4 may be placed in a base handle mold and the two case halves may be ultrasonically welded together around the needle portion 2. Next, a second injection molding process may be used to complete the structure of the handle 10. One or more slots on the portion of the needle portion 2 designed to be within the handle 10 can help lock the needle into the handle after the case halves have been molded (and prior to welding) by preventing rotation of the needle relative to the handle during the rotational pass of the needle tip 5 through tissue. The slots may also prevent pull out of the needle from the handle. The slots may also serve to orient the needle tip relative to the handle to ensure the desirable, proper orientation of the handle relative to the needle during construction of the surgical instrument.

[0057] A first base handle mold can form, for example, the portion of the handle 10 that does not include the tactile surfaces 35. Another base handle mold could form other structures such as the tactile surfaces 35. Polymeric materials for the handles can comprise any suitable polymer such as polycarbonate or a copolymer of acrylonitrile, butadiene and styrene (ABS). Suitable materials include RTP 300 Z Polycarbonate available from RTP Company or Bayer's Lustran ABS.

[0058] An insert or other portion of a first mold may be used to preserve room for a second injection molding (an overmold) of a second polymeric material. For example, the second injection molding may form the tactile surfaces 35 and sides 34 and 36. Any suitable polymeric material may be used for the overmolding process. Suitable examples include, but are not limited to Pellethane urethane, or Santoprene 8211-55B100 from Advanced Elastomer Systems. The second material may run through the handle 10, connecting the major surfaces.

[0059] The surgical instruments shown in FIGS. 1-7 are only embodiments of the present invention, and one of ordinary skill in the art who is exposed to this disclosure will recognize that other embodiments and representations are within the scope of the present invention. FIGS. 8-14 show another embodiment of surgical instrument 100.

[0060] The surgical instrument 100 has a needle portion with a substantially straight portion 102 and a substantially curved portion 104 terminating in a tip 105. The tip 105 is preferably blunt, but it may also be sharp or substantially sharp. An eyelet may optionally be present near the tip 105.

[0061] The needle portion is preferably constructed of a metallic material. The surgical instrument 100 also has a handle portion preferably constructed at least in part from a polymeric material. The handle portion is permanently affixed to the needle portion.

[0062] The handle portion comprises a proximal end region 112, a distal end region 114, and a transition region 115 between the proximal and distal end regions. The transition region 115 is reduced in size relative to the proximal 112 and distal 114 end regions. This reduced size of the transition region 115 affords the capacity to enhance the mechanical association between a user's hand and the handle of the instrument 100. It is believed that a user's hand can more readily conform to the shape of the handle than that of a purely cylindrical handle.

[0063] As seen in FIGS. 8-14, the proximal end region 112, distal end region 114 and transition region 115 have maximum heights and widths. Preferably, the maximum height of the transition region is less than the maximum height of the proximal end region. Also preferably, the maximum height of the transition region is less than the maximum height of the distal end region. Preferably, the maximum width of the transition region is less than the maximum width of the proximal end region. Also, the maximum width of the transition region is preferably less than the maximum width of the distal end region.

[0064] All patents, patent applications, journal articles and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated.

[0065] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.