Patent Document

REFERENCE TO RELATED APPLICATION  
       [0001]     This application is a continuation application of U.S. patent application Ser. No. 10/815,338, filed Apr. 1, 2004, which a continuation-in-part application of U.S. patent application Ser. No. 10/165,468, filed Jun. 7, 2002, which claims priority to U.S. Provisional Patent Application Ser. No. 60/310,220, filed Aug. 6, 2001. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates generally to surgical suturing and, in particular, to improved articles, instrumentation, and methods therefore.  
       BACKGROUND OF THE INVENTION  
       [0003]     Suture passing is problematic for the arthroscopic surgeon because the braided suture preferred by most arthroscopists cannot be pushed through a cannulated instrument. Braided suture must be pulled into location because applying a push force causes the braid to expand in diameter, thereby wedging in the instrument.  
         [0004]     Various solutions have been devised for passing braided suture. The Caspari Suture Punch (Linvatec Corporation, Largo, Fla.) has been a very useful arthroscopic suture-passing instrument. Tissues may be approached head on, grasped and punctured with a cannulated needle, then monofilament suture wheeled through the tissue. A doubled monofilament may be used as a shuttle to pass another braided suture or, alternatively, a Linvatec Suture Shuttle may be wheeled through a slotted Caspari Suture Punch and used to shuttle suture. Surgical Dynamics has a similar device that shuttles a needle from one side of the punch to the other, passing the needle and attached thread through tissue.  
         [0005]     The Caspari suturing instrument, described in U.S. Pat. Nos. 4,890,615, 4,923,461 and 4,957,498, includes a hollow needle for penetrating tissue to be sutured within the body while the tissue is clamped between relatively movable jaws, and a suture feed mechanism for feeding suture material through the hollow needle such that the jaws may be opened and the suturing instrument withdrawn from the body pulling the free end segment of the suture material with the instrument. A knot may be tied in the suture material externally of the body and the knot moved back into the body at a position adjacent the tissue.  
         [0006]     U.S. Pat. No. 5,254,126 discloses an endoscopic suture punch for use in endosurgical procedures having an elongate frame and a handle mounted to one end of the frame. A pair of opposed jaws having tissue punches is mounted to the other end of the frame. One jaw is rigidly mounted to the frame while the other jaw is movably mounted to the frame, although both jaws may be movably mounted. An actuation handle is mounted to the frame for actuating the jaws. The suture punch has a suture pathway through the frame, the punches and the jaws for receiving the suture. There is a suture drive mechanism mounted to the frame for moving the suture through the suture pathway.  
         [0007]     The surgical suturing apparatus described in U.S. Pat. No. 5,454,823 comprises upper and lower jaw elements selectively movable relative to one another between open and closed position. Each jaw element is provided with a respective recess arranged to receive a portion of an elongate incision member or length of surgical thread and securing means is provided arranged to selectively secure the surgical incision member or length of surgical thread in a respective recess. The jaw elements are typically provided at an end of an elongate positioning and operating arm making the device particularly useful for use in laparoscopic surgery.  
         [0008]     More recently, U.S. Pat. No. 6,051,006 describes a suture-passing forceps having a first jaw with a mount which supports a needled suture and a second jaw having a passage, which when aligned with the mount, is positioned to receive the needled suture. The second jaw is positioned relative to the mount in a manner which allows delivery of the instrument to a surgical site in a low profile, delivery position (e.g., with the jaws spaced relatively closely). The surgical instrument includes an elongated shaft having a distal region for supporting the jaws. The second jaw is pivotable, with respect to the mount, between the delivery position in which the second jaw is spaced relatively closely to the mount with the passage misaligned with the mount and an open, misaligned position, the second jaw being axially translatable relative to the mount to an open, aligned position in which the passage is aligned with the mount.  
         [0009]     A shortcoming of these and other such devices is the lack of room available to open the jaws sufficiently in tight spaces (a clearance issue), difficulty in forcing the tooth through the full thickness of the tissue (the tip gradually dulls and some tissue like the rotator cuff is just too thick) and fairly large diameter cannulas are required for passage.  
         [0010]     Other “blitzes” and similar devices also have rather large diameter cannulated needles that pierce the tissue then deploy a loop or other mechanism to transport suture through the tissue. These are cumbersome to use, often requiring skillful rotation and pushing of the device by the surgeon to accomplish the selected result. Additionally, some concern exists with regard to the size of the hole placed in the tissue and the amount of damage requiring repair. This is especially true of the newer “Arthropierce” instrument currently in use.  
         [0011]     Common to existing devices is a body capable undergoing elastic deformation during use but which retains a preformed shape when in an unconstrained condition. Of particular usefulness in these devices is Nitinol, a so-called “shape retention” alloy having an extremely high yield point. Nitinol components are formed during manufacture to a selected shape, and will return to this shape when in an unconstrained condition even after undergoing significant deformation. Preformed Nitinol needles and shuttles may be passed through cannulated instruments and will return to their original shapes when in an unconstrained state. This allows shuttle loops to be passed through cannulated instruments without permanent deformation. All Nitinol components may be formed to their selected shapes during manufacture.  
         [0012]     As an example of an invention utilizing this effect, U.S. Pat. No. 5,607,435 describes a medical instrument including a tubular section having a leading end terminating in a sharp point and a surgical needle exhibiting “superelastic characteristics.” As such, the needle may remain straight as it is inserted through the delivery tube without developing substantial permanent deformation. While in the delivery tube and in this substantially straight condition, the needle is delivered to the suturing site. Once at the suture site, the surgical needle is extended out of the leading end of the delivery tube, returning it to its original curved or bent shape for suturing. A suture thread or wire is operatively disposed in the bore of the tubular section with one end extending out the tip through a slot so as to remain in position to form a suture upon removal of the tubular needle from tissue. A tweezers instrument may then be used to grip and tie the thread into a suture knot.  
         [0013]     Similarly, U.S. Pat. No. 5,749,879 discloses a cannulated instrument for use in conjunction with “an elastic needle.” In the preferred embodiment, the needle is of a pseudoelastic shape memory alloy and has an arced shape while the needle&#39;s alloy is in a substantially austenitic phase, and the needle may be stressed into a more straight shape in which the needle&#39;s alloy enters an at least partially more martensitic phase. When the needle is held entirely within the cannula, the needle is straightened and contains more stress-induced-martensite phase. As the needle is extruded from the distal end portion of the cannula, that portion of the needle which extends beyond the cannula returns toward its original shape by a martensitic-to-austenitic shape memory phase change caused by at least partial relief of the stress-induced-martensite in the needle&#39;s alloy. A cannula insert includes a longitudinal bore which may be used to contain a suture attached to the needle. Suitably, the bore may extend longitudinally entirely through the cannula insert, to permit an unlimited length of suture to be pulled therethrough.  
         [0014]     Despite these advances, the need remains for a suture punch capable of passing braided suture without the use of a shuttle or similar means. Beneficially, such an instrument would be capable of passing suture while not requiring multiple or complex sequential operations or a high level of surgeon skill. In other embodiments, it would also be beneficial that the suture punch pass through a small diameter (i.e., 8 mm or less) cannula, and that the hole created in the tissue for passage of the suture be as small as possible.  
       SUMMARY OF THE INVENTION  
       [0015]     This invention overcomes deficiencies in the prior art by providing a suture punch system capable of directly passing suture material, such as braided suture material, through tissue in a simple, one-step process. The system includes three principle components: a malleable needle capable of delivering the suture material to the tissue, a handheld instrument for grasping tissue and controlling needle placement, and a trocar or other mechanism to supply the force required for needle formation and placement.  
         [0016]     The needle differs from standard needles in terms of size, shape and material properties. In beneficial embodiments, the needle is shorter than standard needles, generally 10 to 13 mm in length, and has a cross-section which may be circular or non-circular, including rectangular with at least two parallel sides. The rectangular needles may have varying thicknesses and have a cross-section that ranges from substantially square to substantially flat. Additionally, the needle is made of a malleable material permitting it to be shaped within the handheld instrument and to retain its form while passing through tissue. The needle may also return to its form after passing through the tissue or once any bending force has been removed. Similarly, the distal portion of the trocar may be malleable, thereby permitting shaping within the handheld instrument.  
         [0017]     In contrast to existing suture punches in which the needle or shuttle undergoes only an elastic deformation during use and the functional un-constrained shape of the needle or shuttle is produced during manufacture, the needle of the disclosed device may be inelastically formed to its functional shape during use, allowing the needle to traverse a nonlinear path. More particularly, when passing through the distal tip of the hand instrument, the needle may be inelastically formed by a radial path within the instrument, the plane of the radius being substantially unparallel to the tissue through which the suture is being passed. The formation of this radius is facilitated by the aforementioned parallel sides of the needle cross-section which are constrained by the instrument in such a manner as to place them essentially in the plane of the tissue.  
         [0018]     Needle deformation begins as the tip of the needle passes through the radius within the instrument and continues as the needle is forced distally by a force-supplying mechanism. As the distal tip of the needle pierces the tissue, it continues its radial path through the tissue, the radius of the path being determined by the unconstrained radius of the needle. This unconstrained radius may be larger than that of the forming radius within the instrument due to “spring back” of the needle, the degree of which is determined by the material properties of the needle, its cross section, and features formed in the parallel surfaces of the needle during manufacture.  
         [0019]     Forming of the needle along its length continues as it is passes from the distal tip of the instrument into the tissue. When the proximal end of the needle exits from the instrument, the needle may be entirely radial in shape and traverse an essentially radial path through the tissue. Due to the degree of spring back, the needle, in certain embodiments, may also return to its non-deformed shape. As used herein, the term “spring back” is meant to define the degree of elasticity of the malleable needle after it has exited the instrument. A “spring back” of 100 percent would apply to a needle that returns to its original shape whereas a needle having a “spring back” of 0 percent would maintain the shape of the curved segment of the instrument after the needle has exited the instrument. The present invention may use needles having a degree of spring back of from 0 to 100 percent. In select embodiments, wherein an inelastic material is used, the needle has a spring back of from 0 to about 10 percent. In alternative embodiments, wherein an elastic material is used, the needle has a spring back of from about 90 to about 100 percent.  
         [0020]     After the proximal end of the needle exits the instrument, the needle may be propelled further along its radial path by the force-supplying mechanism, such as a trocar. Additionally, the distal portion of the mechanism may be formed to a radial shape by the instrument in the same manner as the needle. Additionally, the radial shapes of the needle and mechanism may also be coplanar. Engagement of the mechanism with the needle after the needle passes from the instrument may be facilitated by mating surfaces of the mechanism and needle, shaped, for example, to prevent radial or lateral displacement of the needle proximal and mechanism distal surfaces. The mechanism may also be engaged with the needle in a manner that connects the mechanism and needle together such that the connection is capable of being broken after the needle has exited the instrument.  
         [0021]     The passage in the instrument within which the needle travels, and the forming radius in the instrument distal tip, each comprise open-sided channels allowing the suture carried by the needle to travel unimpeded during its forming and insertion into the tissue. As the force-supplying mechanism pushes the needle further into the tissue, the suture is carried along by the needle through the passage formed in the tissue to deliver the suture to the tissue.  
         [0022]     During use, the tissue to be sutured is constrained by pressure applied through closure between the upper, moveable jaw of the instrument and the distal portion of the instrument which acts as a fixed jaw. The upper, movable jaw contains a shaped passageway that allows the curved needle to pass therethrough during use. After the force-supplying mechanism has been fully inserted into the instrument and the needle has achieved maximum travel into the tissue, the mechanism may be withdrawn from the instrument.  
         [0023]     When suturing thin sections, the needle may be passed completely through the tissue and may then be ready for retrieval using the jaws of the punch or another instrument. In the case of thick tissue, 70 percent or more of the needle may protrude from the tissue after the force-supplying mechanism is fully inserted, such that opening the upper jaw slightly and moving the instrument in a proximal direction would cause the needle to wedge in the upper jaw passage, permitting the needle to be withdrawn completely from the tissue. Following this procedure, the needle may be retrieved using the punch or another instrument.  
         [0024]     Accordingly, in one embodiment, the present invention provides suturing instrumentation for suturing tissue having a malleable needle portion having a sharpened distal tip and constructed and arranged to deliver a length of suture material to the tissue; a handheld instrument having a passageway and having a distal end terminating in a nonlinear portion having a first radius; and a force-supplying structure for applying a force to the needle portion, wherein the force-supplying structure includes a distal end capable of pushing the malleable needle portion through the nonlinear portion, such that when the distal end of the handheld instrument is positioned proximate to the tissue to be sutured and the malleable needle portion is pushed by the distal end of the force-supplying structure through the nonlinear portion, the needle portion is deformed, thereby causing the needle portion to deliver the suture material to the tissue.  
         [0025]     In another embodiment, the present invention provides suturing instrumentation for suturing tissue having a malleable needle portion having a sharpened distal tip and constructed and arranged to deliver a length of suture material to the tissue; a handheld instrument having a passageway and having a distal end terminating in a nonlinear portion having a first radius; and a force-supplying structure for applying a force to the needle portion, wherein the force-supplying structure includes a distal end capable of pushing the malleable needle portion through the nonlinear portion, such that when the distal end of the handheld instrument is positioned proximate to the tissue to be sutured and the malleable needle portion is pushed by the distal end of the force-supplying structure through the nonlinear portion, the needle portion is deformed, thereby causing the needle portion to deliver the suture material to the tissue; and a jaw pivotally coupled to the distal end of the handheld instrument for holding tissue as the needle portion and suture material enters into the tissue.  
         [0026]     In yet another embodiment, the present invention provides a suture needle adapted for use with a handheld instrument defining an axis and having an off-axis distal end, the needle including a length of material having a sharpened distal tip and constructed and arranged to deliver a length of suture material; and the material of the needle being malleable, such that when the needle is pushed through the handheld instrument, it elastically deforms in accordance with the off-axis distal end.  
         [0027]     In still another embodiment, the present invention provides a suturing system having a malleable needle portion having a sharpened distal tip and constructed and arranged to deliver a length of suture material; a handheld instrument having a passageway and having a distal end terminating in a nonlinear portion; and a push member configured for movement in the passageway of the handheld instrument, the push member being operative to push the malleable needle portion through the nonlinear portion, such that when the distal end of the handheld instrument is positioned proximate to a tissue to be sutured and the needle portion is pushed by the push member through the nonlinear portion, the needle portion is deformed and enters into the tissue and delivers the suture material to the tissue being sutured.  
         [0028]     In yet another embodiment, the present invention provides a method for suturing, including the steps of providing a malleable needle portion having a sharpened distal tip; positioning the needle in a passageway of a handheld instrument; providing a suture material to be delivered by the needle portion; and using a push member to push the needle portion in the handheld instrument, the needle portion upon exiting the handheld instrument penetrating the tissue being sutured and delivering the suture material to the tissue being sutured.  
         [0029]     In still another embodiment, the present invention provides a system and method for suturing using a smaller suture wherein the needle is designed such that the suture may be looped back directly into the needle. As such, when the push member pushes the needle portion into and/or through the tissue, the needle delivers a loop of suture material that may then be used as an eyelet or other mechanism for the transfer of other suture. Alternatively, a smaller needle may be used during delivery of the suture to create a loop of suture material in the tissue to be sutured. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0030]      FIG. 1  is a plan view of a suture punch formed in accordance with the principles of this invention;  
         [0031]      FIG. 2  is a side view of the instrument of  FIG. 1 ;  
         [0032]      FIG. 3  is an end view of the instrument of  FIG. 1 ;  
         [0033]      FIG. 4  is an expanded view of the distal tip of the instrument of  FIG. 1 ;  
         [0034]      FIG. 5  is a sectional view of the distal tip of  FIG. 2  at location A-A;  
         [0035]      FIG. 6  is a sectional view of the distal tip of  FIG. 2  at location B-B;  
         [0036]      FIG. 7  is a sectional view of the instrument at location C-C;  
         [0037]      FIG. 8  is a sectional view of the instrument at location D-D;  
         [0038]      FIG. 9  is a sectional view of the instrument at location E-E with the trocar and needle removed;  
         [0039]      FIG. 10  is an expanded view of the distal tip of the instrument;  
         [0040]      FIG. 11  is a plan view of a needle constructed in accordance with the principles of this invention;  
         [0041]      FIG. 12  is a side view of the needle of  FIG. 5 ;  
         [0042]      FIG. 13  is an end view of the needle of  FIG. 5 ;  
         [0043]      FIG. 14  is a plan view of the upper jaw of the instrument;  
         [0044]      FIG. 15  is a side view of the upper jaw of  FIG. 14 ;  
         [0045]      FIG. 16  is a sectional view of the upper jaw of  FIG. 14 ;  
         [0046]      FIG. 17  is an end view of the upper jaw of  FIG. 14 ;  
         [0047]      FIG. 18  is a trocar used in accordance with one embodiment of this invention;  
         [0048]      FIG. 19  is an expanded view of the distal end of the trocar of  FIG. 18 ;  
         [0049]      FIG. 20  is an expanded sectional view of the proximal end of the trocar of  FIG. 18 ;  
         [0050]      FIG. 21  is an expanded view of the distal portion of the trocar of  FIG. 19 ;  
         [0051]      FIG. 22  is an end view of the trocar of  FIG. 18 ;  
         [0052]      FIG. 23  is a sectional view of the instrument of  FIG. 1  with trocar and needle in place;  
         [0053]      FIG. 24  is an expanded view of the distal portion of  FIG. 23 ;  
         [0054]      FIG. 25  shows a needle and trocar loaded and the upper jaw open in preparation for use;  
         [0055]      FIG. 26  is an expanded view of the distal end of the instrument of  FIG. 25 ;  
         [0056]      FIG. 27  depicts the instrument grasping tissue in preparation for passing a needle with suture therethrough;  
         [0057]      FIG. 28  is an expanded view of the distal end of the instrument grasping tissue as shown in  FIG. 27 ;  
         [0058]      FIG. 29  shows the trocar now advanced so that the needle tip is beginning to pierce tissue grasped between the instrument jaws;  
         [0059]      FIG. 30  is an expanded view of the distal end of the instrument shown in  FIG. 29 ;  
         [0060]      FIG. 31  shows the trocar advanced so that the needle has approximately 90 percent penetration of tissue grasped between the instrument jaws;  
         [0061]      FIG. 32  is an expanded view of the distal end of the instrument shown in  FIG. 31 ;  
         [0062]      FIG. 33  shows the trocar advanced so that the needle has passed through tissue grasped between the instrument jaws and protrudes beyond the superior surface of the moveable jaw;  
         [0063]      FIG. 34  is an expanded view of the distal end of the instrument of  FIG. 33 ;  
         [0064]      FIG. 35  shows the trocar fully advanced so that the trocar distal tip has forced the needle proximal end significantly through the tissue grasped between the instrument jaws;  
         [0065]      FIG. 36  is an expanded view of the distal end of the instrument of  FIG. 35 ;  
         [0066]      FIG. 37  is similar to  FIG. 35 , but with the trocar retracted so that only the needle and suture remain within the tissue;  
         [0067]      FIG. 38  is an expanded view of the distal end of the device of  FIG. 37 ;  
         [0068]      FIG. 39  is similar to  FIG. 37 , but with the moveable jaw retracted;  
         [0069]      FIG. 40  is an expanded view of the distal end of  FIG. 39 ;  
         [0070]      FIG. 41  is similar to  FIG. 30 , but with the distal end retracted proximally from the tissue so that the needle is pulled from the tissue by the moveable jaw;  
         [0071]      FIG. 42  is an expanded view of the distal end of  FIG. 41 ;  
         [0072]      FIG. 43  is similar to  FIG. 41 , but with the needle grasped between the jaws of the instrument;  
         [0073]      FIG. 44  is an expanded view of the distal end of  FIG. 43 ;  
         [0074]      FIG. 45  is similar to  FIG. 43 , but with the needle rotated and grasped between the jaws in preparation for withdrawal through the cannula;  
         [0075]      FIG. 46  is an expanded view of the distal end of  FIG. 45 ;  
         [0076]      FIG. 47  is a plan view of an alternate needle configuration according to the invention;  
         [0077]      FIG. 47   a  is a plan view of an alternate suture configuration according to one embodiment of the invention;  
         [0078]      FIG. 48  is a side view of the needle configuration of  FIG. 47 ;  
         [0079]      FIG. 49  is an end view of the needle configuration of  FIG. 47 ;  
         [0080]      FIG. 50  is a plan view of yet a further alternate needle configuration according to the invention;  
         [0081]      FIG. 51  is a side view of the alternate needle configuration of  FIG. 50 ;  
         [0082]      FIG. 52  is an end view of the alternate needle configuration of  FIG. 50 ;  
         [0083]      FIG. 53  is a plan view of an alternate top jaw configuration according to the invention;  
         [0084]      FIG. 54  is a side view of the alternate top jaw configuration of  FIG. 53 ;  
         [0085]      FIG. 55  is an end view of the alternate top jaw configuration of  FIG. 53 ;  
         [0086]      FIG. 56  is a sectional view of the alternate top jaw configuration of  FIG. 53 ;  
         [0087]      FIG. 57  is a sectional view of upper and lower jaws with jaws closed and needle fully extended;  
         [0088]      FIG. 58  is a sectional view of upper and lower jaws with jaws opened 50 percent and needle fully extended;  
         [0089]      FIG. 59  is a sectional view of upper and lower jaws with jaws opened 100 percent and needle fully extended;  
         [0090]      FIG. 60  is a sectional view of upper and lower jaws with jaws opened 100 percent and the suture being pulled through the tissue;  
         [0091]      FIG. 61  is a plan view of yet a different alternate needle according to the invention;  
         [0092]      FIG. 62  is a lateral side view of the different alternate needle of  FIG. 61 ;  
         [0093]      FIG. 63  is an end-on view of the alternate needle of  FIG. 61  viewed from the distal tip;  
         [0094]      FIG. 64  is a plan view of an alternate construction of the upper/moveable jaw;  
         [0095]      FIG. 65  is a side view of the alternate construction of the upper/moveable jaw of  FIG. 64 ;  
         [0096]      FIG. 66  is a bottom-side plan view of the alternate construction of the upper/moveable jaw of  FIG. 64 ;  
         [0097]      FIG. 67  is an end view of the alternate construction of the upper/moveable jaw of  FIG. 64  from the proximal end;  
         [0098]      FIG. 68  is an end view of the alternate construction of the upper/moveable jaw of  FIG. 64  from the distal tip;  
         [0099]      FIG. 69  is a sectional view of the alternate construction of the upper/moveable jaw of  FIG. 64  in direction J-J;  
         [0100]      FIG. 70  Is a sectional view of the alternate construction of the upper/moveable jaw of  FIG. 64  in direction K-K;  
         [0101]      FIG. 71  is a sectional view of the alternate construction of the upper/moveable jaw of  FIG. 64  in direction L-L;  
         [0102]      FIG. 72  is a sectional view of the upper jaw of  FIG. 64  assembled to the lower jaw and with the needle of  FIG. 61  deployed in tissue and ready for retrieval;  
         [0103]      FIG. 73  is a sectional view of the upper jaw of  FIG. 64  assembled to the lower jaw and with the needle of  FIG. 61  captured in the upper jaw;  
         [0104]      FIG. 74  is a sectional view of the upper jaw of  FIG. 64  assembled to the lower jaw and with the needle of  FIG. 61  captured in the upper jaw and withdrawn from the tissue;  
         [0105]      FIG. 75  is a sectional view of the upper jaw of  FIG. 64  assembled to the lower jaw and with the needle of  FIG. 61  captured by the instrument and positioned for withdrawal through a cannula;  
         [0106]      FIG. 76  is an alternate needle having a radial shape and made of Nitinol;  
         [0107]      FIG. 77  is a plan view of the needle of  FIG. 76  prior to forming;  
         [0108]      FIG. 78  is an end view of the needle of  FIG. 76 ;  
         [0109]      FIG. 79  is a plan view of an alternate needle according to the invention;  
         [0110]      FIG. 80  is a side view of the needle of  FIG. 79 ;  
         [0111]      FIG. 81  is an end view of the needle of  FIG. 79 ;  
         [0112]      FIG. 82  is a plan view of an alternate top jaw according to the invention;  
         [0113]      FIG. 83  is a side view of the alternate top jaw of  FIG. 82 ;  
         [0114]      FIG. 84  is a side sectional view of the alternate top jaw of  FIG. 82 ;  
         [0115]      FIG. 85  is an end view of the alternate top jaw of  FIG. 82 ;  
         [0116]      FIG. 86  is an expanded lateral sectional view of the alternate top jaw of  FIG. 82 ;  
         [0117]      FIG. 87  is a drawing of a jawless suture punch according to the present invention;  
         [0118]      FIG. 88  is a drawing of a trocar pusher adapted for use with the jawless punch of  FIG. 87 ;  
         [0119]      FIG. 89  is a drawing of the distal tip of an angled jaw or jaw-less design according to the present invention;  
         [0120]      FIG. 90  is a drawing of a particularized capsular plication suture punch for the shoulder according to the present invention;  
         [0121]      FIG. 91  is a simplified drawing which shows the way in which three rigidly positioned points may be used to curve a needle into a selected radius according to the present invention;  
         [0122]      FIG. 92  is a drawing depicted in partial transparent form, illustrating a more sophisticated jawless punch according to the present invention;  
         [0123]      FIG. 93  is an oblique view of the device of  FIG. 92 ;  
         [0124]      FIG. 94  is a close-up view of the distal end including the curved tip;  
         [0125]      FIG. 95  is a side-view of the device of  FIG. 93  with the needle loaded in position;  
         [0126]      FIG. 96  is a perspective-view of the configuration shown in  FIG. 95 ;  
         [0127]      FIG. 97  is a side-view showing the trocar being advanced by pushing on the proximal end of the pusher rods;  
         [0128]      FIG. 98  shows the needle being pushed passed the breached loading position, with the suture material extending out from a slot;  
         [0129]      FIG. 99  shows the needle being deformed and pushed out the distal end;  
         [0130]      FIG. 100  shows the needle fully advanced, now free of the distal tip of the instrument;  
         [0131]      FIG. 101  is a close-up, detail view of the needle emerging from the curved distal tip of the instrument;  
         [0132]      FIG. 102A  shows the jaws open ready to grab the tip of the needle;  
         [0133]      FIG. 102B  shows the needle grasped;  
         [0134]      FIG. 102C  shows how, even once grasped, the tip of the needle may rotate within the jaws;  
         [0135]      FIGS. 103A-103C  are side views of the embodiments of  FIGS. 102A-102C ;  
         [0136]      FIG. 104  is a perspective view of the grasping mechanism in conjunction with the tip of the needle;  
         [0137]      FIG. 105A  is a first view of a needle according to the invention particularly suited to certain shoulder procedures;  
         [0138]      FIG. 105B  is a different view of the needle of  FIG. 105A ;  
         [0139]      FIG. 105C  is a end-on view of the needle of the  FIGS. 105A and 105B ;  
         [0140]      FIG. 106  is a retrieval instrument associated with the needle of  FIG. 105 ;  
         [0141]      FIG. 107A  is a close-up view drawing of the retrieval tip of the instrument of  FIG. 106 ;  
         [0142]      FIG. 107B  is a different view of the retrieval tip;  
         [0143]      FIG. 107C  is an end-on view of the retrieval tip;  
         [0144]      FIG. 108  shows a distal portion of an insertion instrument; and  
         [0145]      FIG. 109A through 109K  show the way in which the needle of  FIG. 105 , insertion of  FIG. 108  and retrieval instrument of  FIGS. 106 and 109  are used. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0146]     The present invention is more particularly described in the following examples that are intended to be illustrative only since numerous modifications and variations therein will be apparent to those skilled in the art. As used in the specification and in the claims, the singular form “a,” “an,” and “the” may include plural referents unless the context clearly dictates otherwise. Also, as used in the specification and in the claims, the term “comprising” may include the embodiments “consisting of and ” consisting essentially of.” 
         [0147]     The present invention will now be further described through the following drawings. It is to be understood that these drawings are non-limiting and are presented to provide a better understanding of various embodiments of the present invention and are not intended to represent every possible embodiment of the present invention.  
         [0148]     Referring to the drawings, as best seen in  FIGS. 1 through 9 , the instrument body  11  has a proximal end  1  and a distal end  2 . The distal end further includes a fixed portion (or fixed jaw)  3  and a movable portion (or moveable jaw)  4 . The movable portion  4  is rotatable about pin  5  passing through the movable portion  4  and fixed portion  3  thereby forming a hinge.  
         [0149]     The position of movable jaw  4  is determined by positioning rod  6  which transmits an opening or closing force to movable portion  4  via hinge pin  7 . The position of positioning rod  6  is determined by the position of movable handle  8 , which is connected to the proximal end of positioning rod  6  through pin  9 . The positioning rod  6  passes through elongated section  18  of instrument body  11  and through passage  17 .  
         [0150]     Movable handle  8  is rotatably affixed to the instrument body  11  by pin  10  so that rotating movable handle  8  counterclockwise opens movable jaw  4  and rotating movable handle  8  clockwise closes movable jaw  4  with a closure force proportional to that applied between movable handle  8  and fixed handle  12 . Closure pressure between the jaws may be maintained by a ratcheting action created through the interraction between tooth section  13  of movable handle  8  and serrations  14  on arcuate section  15  of fixed handle  12 .  
         [0151]     Closure pressure may be released by elastically deforming arcuate section  15  upward with pressure applied to proximal end  16  of the arcuate section. Fixed jaw  3  and movable jaw  4  may include serrations  8  formed on their angularly transposed surfaces to facilitate the grasping of tissue placed between them. Removable trocar  70  protrudes from the proximal end of instrument body  11 .  
         [0152]     As is best seen in  FIGS. 11 through 13 , one embodiment of the needle  20  has a proximal end  21  and a distal end  22 , and a rectangular cross-section  27  with upper surface  28 , lower surface  29  and lateral surfaces  30 . The proximal end  21  includes a contoured proximal surface  23 , conical in shape in one embodiment, and having a conical angle  24  and a conical axis  25  coaxial with needle centerline  26 . The distal end  22  is shaped to form a cutting edge  28  having included angle  27 . Suture  31  is connected to a needle lateral surface  30  at a distance  32  from the needle proximal end.  
         [0153]     As is best seen in  FIGS. 4, 5 ,  9 , and  10 , the instrument body  11  has a continuous passage  40  of varying cross-section extending from the proximal-most face  41  of instrument body  11  to the upper surface  42  of fixed jaw  3  near the jaw&#39;s distal tip. In section  43 , extending a distance  44  from proximal face  41 , the passage has a cylindrical cross-section of a specified diameter  56  as shown in  FIGS. 7 and 8 . In section  45 , extending a distance  46  from the distal end of section  43 , the passage is a rectangular channel  44 , the height of the channel  51  being slightly greater than the thickness  45  of needle  20 . Distance  46  is sufficiently longer than the length of needle  20  to allow easy placement of the needle in the slot.  
         [0154]     Section  47  of the slot extends from the distal end of section  45  to the termination of the slot at the top surface  42  of fixed jaw  3  and beneficially includes of a linear portion  48  and a radial portion  49  having a known radius  50 . As is best seen in  FIG. 5 , the cross-section of channel  40  in section  47  is rectangular having a height  51  slightly greater than the thickness  45  of needle  20  and a width  52  slightly greater than width  53  of needle  20 . A slot  54  having a height  55  less than height  51  of passage  40  extends through the entirety of section  47 .  
         [0155]     As is best seen in  FIGS. 14 through 17 , upper jaw  4  contains a shaped passageway  60  having a width  61  slightly larger than width  52  of passage  40  and extending from the jaw&#39;s lower surface  63  to upper surface  64 . As best seen in  FIGS. 4 and 10 , upper jaw  4  protrudes distally a distance  62  beyond lower jaw  3 .  
         [0156]     Referring to  FIGS. 18 through 22 , the force-supplying mechanism is a trocar  70  that is an assembly including a stepped cylindrical rod  71  and hub  72  and having a distal end  73  and proximal end  74 , with the hub being attached to proximal end  74 . Stepped metallic cylindrical rod  71  features a larger diameter section  75  of specified length  76  and diameter  77 , with the diameter being slightly smaller than diameter  56  of section  43  of passage  40  so allowing trocar  70  may move freely within instrument body  11  when inserted into passage  40 . Cylindrical rod  71  has a smaller diameter section  78  of specified length  79  and diameter  80 , with the diameter being slightly smaller than height  51  of sections  45  and  47  of passage  40  allowing trocar  70  to move freely within elongated section  18  of instrument body  11  when inserted into passage  40 . Rod  71  is hardened throughout its length to prevent bending, except section  81  extending a length  82  from distal tip  73  is annealed for high malleability. Distal tip  73  is formed to a conical shape of conical angle  83 , with the conical angle being equal to conical angle  24  on proximal end  21  of needle  20 .  
         [0157]     Referring to  FIGS. 23 and 24 , when prepared for use, needle  20  is inserted laterally into section  45  of passage  40  with the lateral surface  30  with suture  31  facing the open side of channel  40  and suture  31  extending from elongated section  18  of body  11 . After insertion, needle  20  is moved distally to section  47  of channel  40 ; trocar  70  is inserted into channel  40  of instrument body  1 , and positioned as shown in  FIGS. 23 and 24 .  
         [0158]     Referring to  FIGS. 25 and 26 , when using the instrument to pass a suture the movable jaw  4  is opened using movable handle  8 . Trocar  70  is inserted into instrument body  11  until trocar distal end  73  engages needle proximal end  21 . Suture  31  carried by the needle  20  moves freely in slot  54 .  
         [0159]     During use of the device, as seen best in  FIGS. 27 and 28 , tissue is grasped between upper jaw  4  and lower jaw  3 . Referring to  FIGS. 29 and 30 , advancing trocar  70  a distance  85  distally causes needle  20  to move distally in channel  20 , the distal portion of the needle being formed to a radius  50  by the radial portion  49  of passage  40 .  
         [0160]     Referring to  FIGS. 31 and 32 , advancing the trocar an additional distance  86  causes needle  20  to be formed to a radial shape of radius  87 , radius  87  being larger than radius  50  of section  49  of passage  40  due to spring back of the needle after leaving the passage radial section  49 . Needle  20  follows a radial path through the tissue. Advancing trocar  70  an additional distance  88  (see  FIGS. 33 and 34 ) causes needle  20  to advance along its radial path until needle distal tip protrudes above top surface  64  of movable jaw  4 , having passed through jaw  4  via passage  60 .  
         [0161]     As is best seen in  FIGS. 35 and 36 , advancing trocar  70  distally until hub  72  contacts distal face  41  of instrument body  11  advances needle  20  further through the tissue, with distal tip  73  of trocar  70  assuming a radial shape of radius  87  as it passes through radial portion  49  of passage  40 . Alignment between trocar distal tip  73  and needle proximal end  21  is maintained by engagement of the needle proximal end conical recess with the with the trocar distal tip conical protrusion, needle proximal end conical radius  24  and trocar distal tip conical radius  83  being equal. In this manner, needle  20  and suture  31  are advanced a distance  89  into the tissue beyond the top surface of lower jaw  3 .  
         [0162]     As is best seen in  FIGS. 37 and 38 , withdrawing trocar  70  a distance  90  causes the trocar distal tip  73  to be withdrawn from the tissue into the distal portion of passage  40 , leaving needle  20  and suture  31  in the tissue, with needle distal tip  22  protruding well above the top surface of upper jaw  3 . As seen in  FIGS. 39 and 40 , upper jaw  3  is now retracted with needle  20  moving freely within passage  60 . Referring now to  FIGS. 41 and 42 , withdrawing the instrument axially causes needle  20  in slot  60  of upper jaw  3  to be pulled free from the tissue with suture  31  now passing through the tissue. Referring to  FIGS. 43 and 44 , closing jaw  3  causes it to grasp needle  20  thereby allowing further retraction of the needle and the suture. As seen in  FIGS. 45 and 46 , jaws  3  and  4  may be opened thereby freeing needle  20 , and the needle rotated 90 degrees and re-grasped by jaws  3  and  4 .  
         [0163]     Although the above description references “needle  20 ,” various other needle designs are equally applicable to the invention. In another embodiment, shown in  FIGS. 47 through 49 , needle  92  has a cross-section with two parallel sides, the lateral faces having a nearly radial profile, a shape producible by coining a cylindrical needle. Additionally, prior to delivery of the suture material, the suture material may be a standard suture or may be a smaller suture. As shown in  FIG. 47   a , the suture material may be looped back into the needle  92  such that when the needle  92  is delivered to the tissue, a loop of suture material is delivered that may then be used for other purposes, such as an eyelet for the transfer of other sutures.  
         [0164]     In another embodiment, shown in  FIGS. 50 through 52 , needle  94  has a non-uniform cross-section, upper and lower surfaces  95  and  96  having a plurality of angled surface segments  98  of angle  95  each surface terminating in a radius  96  so as to form a series of notches useful in engaging comers of passage  60  in upper jaw  3  so as to aid in needle retraction during axial withdrawal of the instrument.  
         [0165]     In addition to alternative needle designs, jaw construction is likewise variable in accordance with the invention. In another embodiment, best seen in  FIGS. 53 through 56 , upper jaw  100  is of similar construction to upper jaw  3  except that passage  60  has been replaced with slot  101 . As is best seen in  FIGS. 57 through 59 , the distal protrusion  62  of upper jaw  4  beyond lower jaw  3  is required to allow needle  20  to enter passage  60  throughout the range of positions of upper jaw  4 .  FIG. 60  is a sectional view of upper and lower jaws with jaws opened 100 percent and the suture being pulled through the tissue.  
         [0166]     A further alternate needle  201  is shown in  FIGS. 61 through 63 . As is best seen in  FIG. 62 , the needle of thickness  220  has a distal end  202  and a proximal end  203 , with the distal end formed to a wedge shape having included angle  204  so as to form a cutting edge  205 . The proximal end  203  has a conical shape  206  formed therein and having an angle  207  equal to angle  83  on the distal tip of trocar  70  shown in  FIGS. 18 through 22 . As is best seen in plan view  FIG. 61 , needle  201  has three sections distinguished by their width. Proximal section  208  and distal section  209  have a width  210 , while medial section  211  has a width of  212  than width  211 . Distal section  209  is not of constant width, but rather tapers to a width  213  at its distal tip. The transition from middle section  211  to proximal section  208  is a taper of length  214  and angle  215 . Suture  216  is connected to lateral surface  217  of proximal section  208  a distance  218  from proximal end  203 .  
         [0167]     An alternate upper jaw to be used in conjunction with alternate needle  201  is shown in  FIGS. 64 through 71 . As is best seen in  FIGS. 64, 66  and  68 , upper jaw  110  is constructed like upper jaw  4  having a distal end  111  and a proximal end  112 , except that upper jaw  110  has a distal end slot  113 , the distal slot having a proximal portion  114  and a distal portion  120 , and the portions being distinguished by their width. Proximal portion  114  has a length  125  and a width  115  which is slightly larger than width  210  of proximal section  208  and distal section  209  of needle  201  as shown in  FIG. 61 . Distal portion  120  has a width of  121  which is slightly larger than width  212  of middle section  211  of needle  201  shown in  FIG. 61 .  
         [0168]     As is best seen when viewing jaw  110  laterally as in  FIG. 65 , distal portion  111  of jaw  110  has a hooked portion  126  formed therein, the hooked portion having a radius  127  and a height  128 , height  128  being somewhat larger than thickness  220  of needle  201  as seen in  FIG. 62 . As is best seen in axial sectional view  FIG. 71 , proximal portion  114  of slot  113  has a portion  130  of height  131  with parallel sides and a portion  132  of height  133  whose lateral facing sides are angled outward at angle  134  so that the bottom of the slot is wider than the top of the slot.  
         [0169]     The functioning of alternate needle  201  and alternate jaw  110  is best seen in  FIG. 72  through  75 . Functioning of the needle and jaw are as explained previously except, referring to  FIG. 72 , needle  201  being of a shorter length than that of needle  20  and trocar  170  being of a shorter length than trocar  70 , when trocar  70  is fully inserted to the limit of its travel, the portion of needle  201  remaining within tissue  171  is greater than that remaining in the previously explained embodiments. The length  175  of the portion of needle  201  protruding beyond tissue  171  is sufficient to cause the distal end of medial portion  211  of needle  201  to extend above surface  172 , needle  201  having passed through proximal portion  114  of slot  113 , and, as shown in  FIG. 72  passed into distal portion  120  of slot  113  due to movement of the instrument proximally.  
         [0170]     In this embodiment, needle  201  is prevented from disengagement from the distal portion  120  of slot  113  because the width  210  of needle distal portion  209  is greater than width  121  of slot distal portion  120 . Needle  201  is able to move freely within slot  113  parallel to the axis of the slot as width  212  of needle medial portion  211  is less than width  121  of distal portion  209  of slot  113 . Referring to  FIG. 73 , withdrawing the instrument proximally causes needle  201  to move distally and pivot within distal portion  120  of slot  113  so as to engage with the hook segment  126  of jaw  110 , thereby allowing needle  201  to be extracted from tissue  171 , causing suture  216  to be pulled through the tissue. As is best seen in  FIG. 74 , after needle  201  is free of tissue  171  upper jaw  110  may be closed and additional suture pulled through the tissue. As seen in  FIG. 75 , jaw  110  may be closed totally thereby allowing needle  201  and suture  216  to be withdrawn through a cannula.  
         [0171]     An alternate needle made of Nitinol and formed to a radial shape during manufacture is shown in  FIGS. 76 through 78 . Manufacture of needle  400  is accomplished in two steps, namely the cutting of the needle blank profile  401  from sheet material, and forming of the needle to a shape having radius  402 , with radius  402  being equal to forming radius  50  of lower jaw  3  as shown in  FIG. 10 . Needle  400  may be used in the same manner as previous embodiments as it will be constrained in a straightened state by channel  47  ( FIG. 9 ) prior to deployment. Needle capture and retrieval are accomplished in the same manner as needle  201  described previously and shown in  FIGS. 72 through 75 . Conversely, a Nitinol needle may be used having a linear shape, which is constrained into the radial shape as the needle passes through the radius of the lower jaw  3 . Additionally, in other embodiments, a smaller Nitinol needle, i.e. having a smaller diameter, may be used for creating a looped suture in the tissue wherein the smaller needle creates a loop in the suture material as it is delivered due to the reduced diameter of the needle.  
         [0172]     An alternate needle  500  having multiple “barbs” displaced along its lateral surfaces is shown in  FIGS. 79 through 81 . The needle features a distal end  501  shaped to a cutting edge  506  having included angle  507 , and a proximal end  502  having a convex conical shape  503  with conical angle  504 . The conical angle is, in one embodiment, equal to distal tip angle  83  of trocar  70 , shown in  FIG. 21 . Suture  508  is attached to a lateral face  510  a distance  511  from distal end  502 . Needle  500  has a width  507  and a number of pyramid-shaped “barbs”  512  displaced along lateral surfaces  510 , the lateral distance  513  between barb tips being greater than width  507 . The barb protrusions are pyramidal in shape having a length  514 , width  515  and height  516 , the distal edge  517  forming an angle  518  with the lateral surface  510 .  
         [0173]      FIGS. 82 through 86  show an alternate upper jaw for use with needle  500 . Jaw  600  in constructed in the manner of jaw  4 , except that jaw  600  includes a hollow structure of wall thickness  602  forming a capture space  601 . The capture space  601  is defined by the walls of the jaw and by the inner surface  603  of the jaw lower wall  604 . Jaw lower wall  604  has a slot  605  of width  606 , width  606  being greater than width  507  of needle  500 , but less than distance  513  between barb tips of needle  500 . The lower section of slot  605  is tapered outward so as to aid needle  500  in entering slot  605 .  
         [0174]     Needle  500  and upper jaw  600  are used in the same manner as needle and jaw configurations previously disclosed; that is, needle  500  is formed to a radial shape by the instrument, passes through tissue confined by pressure from the upper and lower jaws, and enters the upper jaw where it is captured for retrieval. Needle  500  and jaw  600  vary in the method of capture. Distal tip  501  of needle  500  enters slot  605  of jaw  600 , and via the slot enters space  601 . Slot  605 , being less in width than distance  513  between the needle barb tips, causes the barb tips to deform as they pass into space  601  via slot  605 . Also, because wall thickness  602  is rather thin, jaw  600  will spread slightly so as to allow the barbs to pass. Because the barb proximal surfaces are square rather than tapered, the needle is retained in the slot.  
         [0175]     The embodiments described thus far included a pair of jaws, beneficially a fixed jaw and movable jaw, with the later being additionally responsible for any capture of a needle having been radially deformed and passed through tissue. Although the invention has been described in terms of a fixed jaw and a movable jaw, it will be apparent to those of skill in the art of mechanical design that versions of the invention wherein both jaws move are also anticipated, assuming appropriate interaction associated with needle curvature and any capture of the needle.  
         [0176]     In addition, there are situations, and embodiments of this invention, where capture is performed not by a jaw coupled to the same instrument, but rather, through the use of an additional instrument. Reference to  FIGS. 87-91 , which illustrate a simpler suture punch according to the invention, which is similar to the embodiments described above, but does not include an upper jaw to hold tissue and/or retain a needle once formed. Nevertheless, the same type of malleable needle according to the invention having a suture/suture loop is inserted into these simpler devices, and pushed down the channel by a pusher, which acts as the force-supplying mechanism. Since the terminal action of the needle is the same as that used with the more sophisticated device as described herein, the shaft of the channel must be stiff enough to resist a perpendicular vector force required to push the needle through the tissue. One advantage of these alternative designs is that such instruments may be used to plicate the shoulder capsule from the inside arthroscopically.  FIG. 87  is a drawing of a jawless suture punch according to the invention, including a curved distal end  802 , and a proximal end  804  including an insertion point  806 .  FIG. 88  is a drawing of a pusher adapted for use with the jawless punch of  FIG. 87 . The pusher includes a sharpened malleable/spring steel tip  812  coupled to a blunt  814  through an eyelet  816  to receive a thread or suture loop. In operation, the curved tip  802  is placed next to tissue to be sutured, and the sharp tip inserted into the insertion point  806 . The sharp tip is then advanced with the pusher of  FIG. 88  through the tissue, allowing the suture to be pulled through the tissue as well.  
         [0177]      FIG. 89  is a drawing of a lower jaw of a suture punch or a jaw-less design according to the invention. According to this embodiment, a malleable needle is inserted into a loading slot  820  such that the tip of the needle is proximate to the distal end by a distance of ⅛ inch, or thereabouts. The instrument is inserted through cannula, upon which time the tissue is grasped and a flexible trocar is pushed down trocar channel  822 . As the flexible tip of the trocar nears the needle slot  820 , the bend in the channel directs the tip down the needle slot, engaging the proximal end of the needle. As the trocar is advanced further, the needle is pushed through the forming section of the lower jaw, resulting in a deformation similar if not identical to the other embodiments described herein.  FIG. 90  is a drawing of a particularized capsular plication suture punch for the shoulder according to the invention. Distance d indicates the portion of the capsule to be plicated, with the capsule surface being shown at  902 . A malleable needle is inserted into the proximal end of the device, which penetrates into and out of the capsule, with the entire instrument remaining on one side of the surface  902 . The depth of the penetration may be controlled for the curvature of the insertion channel, and the malleability characteristics of the needle.  FIG. 91  is a simplified drawing which shows the way in which three rigidly positioned points may be used to curve a needle into a selected radius according to the invention. Once the needle and suture passes through the capsule, a separate needle capture mechanism  910  may be used to pull the suture through, as described elsewhere herein.  
         [0178]      FIG. 92  is a drawing depicted in partial transparent form, illustrating a more sophisticated jawless punch according to one embodiment of the invention, including yet a further alternative needle including a distal tip configured for grasping with a separate instrument. The instrument depicted generally at  920  includes a body portion having a squeeze handle  922  coupled to a ratchet  924  which engages with barbs  926  on a pusher mechanism. The pusher mechanism extends through the barrel of the instrument down to the distal tip  930 , which terminates in a curved portion  932 , and includes a breach loading slot  934  to receive a needle  940  attached to suture  941  and including a distal tip  942  configured for grasping.  FIG. 93  is an oblique drawing of the device of  FIG. 92 .  FIG. 94  is a close-up view drawing of the distal end  930  including curved tip  932 , breach loading slot  934  and specialized needle  940  having a tip  942  configured for manual grasping, the needle  940  being attached at its proximal end to suture material  941 .  FIG. 95  is a side-view drawing of the device of  FIG. 93  with the needle loaded in position;  FIG. 96  is a perspective-view drawing of the configuration shown in  FIG. 95 .  FIG. 97  is a side-view drawing showing the trocar being advanced by pushing on the proximal end of the pusher rods.  FIG. 98  is a detail drawing showing the needle being pushed passed the breached loading position, with the suture material extending out from a slot, and with the needle in position just prior to deformation.  FIG. 99  is a drawing which shows the needle being deformed and pushed out the distal end, as handle  922  is compressed, causing the ratchet  924  to advance the barbs  926  on the pusher rod.  FIG. 100  is a drawing which shows the needle fully advanced, now free of the distal tip of the instrument.  FIG. 101  is a close-up, detail view of the needle emerging from the curved distal tip of the instrument.  
         [0179]     As discussed above, with respect to the jawless embodiments of this invention, a separate instrument would generally be used to grasp the formed needle, having passed through tissue to be sutured. While conventionally available tools such as forceps, and the like, may be used for such purpose, particularly with respect to the specialized needle shown in  FIG. 94  and elsewhere herein, specialized needle grasping instruments may be provided, as shown in  FIGS. 102-104 .  FIG. 103A  is a drawing which shows a grasping mechanism  1002  having a specially shaped set of jaws to capture the tip of certain needles described herein. In particular, the embodiments of  FIGS. 102-104  are specially suited to grasp the tip of the needle best seen in  FIG. 94 .  FIG. 102A  shows the jaws open ready to grab the tip of the needle.  FIG. 102B  shows the needle grasped, and  FIG. 102C  shows how, even once grasped, the tip of the needle may rotate within the jaws.  FIGS. 103A-103C  are side views of the embodiments of  FIG. 102A-102C , and  FIG. 104  is a perspective view of the grasping mechanism in conjunction with the tip of the needle.  
         [0180]     Yet a further embodiment, intended for applications such as the repair of torn meniscus, torn labrum, capsular reefing to the labrum and other applications, is described in the following text and  FIGS. 105 through 109 . This embodiment is different from the previous embodiments in that the distal end of the insertion instrument is configured so that the needle exits the instrument in a direction that is axial to the instrument, wherein a normal to the distal-most surface is parallel to the axis of the instrument. The needle is formed to a somewhat larger radius so that when it is fully inserted the needle tip protrudes from the upper (or lower) surface of the tissue undergoing repair, the needle being formed, in one embodiment, less than 90 degrees. When the needle is fully inserted, the insertion instrument is removed leaving the needle and suture embedded in the tissue with its distal tip exposed.  
         [0181]     The retrieval instrument distal end is somewhat like the upper jaw of certain previous embodiments in that it has a hook shape designed to allow the captured needle to pivot freely in the plane in which it is formed. A feature allows the tool to exert a force on a needle tip in the distal as well as the proximal direction. The retrieval instrument distal end is also slotted, the slot having a width slightly greater than that of the reduced width region of the needle, but less than the width of the needle distal tip.  
         [0182]     In use, the wedge shaped distal end of the instrument is inserted so that the reduced region of the needle is engaged by the slot in the instrument. Moving the instrument distally causes the needle to be pulled further through the tissue. When the head is fully engaged in the slot the needle is pulled the rest of the way through the tissue by moving the instrument distally a distance sufficient to free the needle from the tissue and expose a short length of suture. The retrieval instrument is then moved proximally with the needle pivoting in the distal hook so that it may be withdrawn through the cannula. After the needle is freed from the tissue, the retrieval instrument may be rotated about its axis so that the needle pivots in a plane in which there is sufficient space for this to occur.  
         [0183]     Referring to the drawings, as best seen in  FIGS. 105A through 105C , needle  2001  of width W 1  ( 2004 ) and height H 2  ( 2005 ) has a distal end  2002  and a proximal end  2003 . A middle region  2009  having a width W 2  ( 2006 ) forms “shoulders”  2012  at its distal end  2002  which is sharpened. A suture  2007  is attached to lateral surface  2008  a distance L 1  ( 2010 ) from distal-most surface  2011 .  
         [0184]     Referring to  FIG. 106 , retrieval instrument  2020  has a proximal portion  2021  formed to a handle shape and an elongated distal portion  2022  terminating in distal tip  2023 . Referring to  FIGS. 107A through 107C , distal tip  2023  has a slot  2024  of width W 3  ( 2025 ) which is slightly larger than width W 2  ( 2006  in  FIG. 105A ) but less than W 1  ( 2004 ). The profile of distal end  2023  has a distal surface  2026  inclined at an angle A 1  ( 2027 ) and a capture region  2028  bounded on its distal end by hook-shaped surface  2029  and on its proximal end by lateral surface  2030  displaced from surface  2029  a distance L 2  ( 2031 ) and surface  2032 .  
         [0185]      FIG. 108  shows the distal portion  2040  of an insertion instrument of this embodiment. Needle  2001  is positioned in the forming channel  2047  and suture  2007  is affixed to the needle. Distal portion  2040  has two radii, R 1  ( 2041 ) and R 2  ( 2042 ) which together displace forming channel  2045  a distance D 1  ( 2046 ). Radius R 2  ( 2042 ) forms the needle to a radial shape having a radius R 3  ( 2049  in  FIG. 109C ) slightly larger than R 2  ( 2042 ). A normal to distal-most surface  2048  is coaxial with the axis of the axis of portion  2040 .  
         [0186]     Referring to  FIG. 109A , tissue  43  is to be sutured to tissue  2044 . In  FIG. 109B , the “tear” is closed by applying force to tissue  2043  using distal portion  2040 . In  FIG. 109C , needle  2001  has been inserted in the same manner as in the previous embodiment. In  FIG. 109D , the insertion instrument has been removed and needle  2001  remains in place with suture  2007 . In  FIG. 109E , retrieval instrument  2020  has been brought into position.  FIG. 109F , distal tip  2023  has been inserted such that needle  2001  is engaged in slot  2024  and surface  2026  (see  FIG. 107B ) acting on shoulders  2012  ( FIG. 105A ) of needle  2001  has displaced the needle distally in tissue  2043  and  2044 .  
         [0187]     Referring to  FIG. 109G , distal end  2002  of needle  2001  is captured in region  20028  ( FIG. 107B ). Displacing retrieval instrument  2020  distally ( FIG. 109H ) causes needle  2001  to be extracted from tissue  2043  thereby pulling suture  2007  through the tissue. In  FIG. 109I  additional suture has been pulled through the tissue. In  FIG. 109J , retrieval instrument  2020  has been moved proximally causing needle  2001  to pivot in distal tip  2023  . In  FIG. 109K , needle  2001  has pivoted into position for retrieval through a cannula.  
         [0188]     Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings and examples, it is to be understood that the disclosure is not limited to those precise embodiments, and various other changes and modifications may be affected therein by one skilled in the art without departing from the scope of spirit of the disclosure. All such changes and modifications are intended to be included within the scope of the disclosure as defined by the appended claims.

Technology Category: 1