US20040249394A1 - Compact suture punch with malleable needle - Google Patents

Abstract

A suture punch system that is capable of directly passing braided suture through tissue in a simple, one-step process. The system includes three principle components: a malleable needle capable of delivering the suture to the tissue, a handheld instrument for grasping tissue and controlling needle placement, and a force-supplying mechanism to supply the force required for needle placement. Needle deformation begins at the tip of the instrument, which beneficially includes a curved segment. As the distal tip of the needle pierces the tissue, it continues its radial path through the tissue. When the proximal end of the needle exits from the instrument, the needle may be radial in shape and traverses an essentially radial path through the tissue. Non-radial linear or non-linear segments may alternatively be used. In one embodiment, the tissue to be sutured is constrained by pressure applied through closure between an upper, moveable jaw at the distal portion of the instrument, which acts as a fixed jaw. The upper, movable jaw contains a shaped passageway that permits the needle to pass therethrough during use. Once the needle has passed entirely through the tissue it may be retrieved using the jaws of the punch or another instrument. Different needle designs and separate instruments and sutures may be used.

Description

REFERENCE TO RELATED APPLICATION
• This application is 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.[0001]
FIELD OF THE INVENTION
• This invention relates generally to surgical suturing and, in particular, to improved articles, instrumentation, and methods therefore.[0002]
BACKGROUND OF THE INVENTION
• 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.[0003]
• 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.[0004]
• 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.[0005]
• 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.[0006]
• 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.[0007]
• 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.[0008]
• 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.[0009]
• 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.[0010]
• 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.[0011]
• 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.[0012]
• 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's alloy is in a substantially austenitic phase, and the needle may be stressed into a more straight shape in which the needle'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'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.[0013]
• 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.[0014]
SUMMARY OF THE INVENTION
• 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.[0015]
• 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.[0016]
• 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.[0017]
• 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.[0018]
• 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.[0019]
• 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.[0020]
• 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.[0021]
• 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.[0022]
• 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.[0023]
• 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.[0024]
• 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.[0025]
• 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.[0026]
• 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.[0027]
• 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.[0028]
• 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.[0029]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a plan view of a suture punch formed in accordance with the principles of this invention;[0030]
• FIG. 2 is a side view of the instrument of FIG. 1;[0031]
• FIG. 3 is an end view of the instrument of FIG. 1;[0032]
• FIG. 4 is an expanded view of the distal tip of the instrument of FIG. 1;[0033]
• FIG. 5 is a sectional view of the distal tip of FIG. 2 at location A-A;[0034]
• FIG. 6 is a sectional view of the distal tip of FIG. 2 at location B-B;[0035]
• FIG. 7 is a sectional view of the instrument at location C-C;[0036]
• FIG. 8 is a sectional view of the instrument at location D-D;[0037]
• FIG. 9 is a sectional view of the instrument at location E-E with the trocar and needle removed;[0038]
• FIG. 10 is an expanded view of the distal tip of the instrument;[0039]
• FIG. 11 is a plan view of a needle constructed in accordance with the principles of this invention;[0040]
• FIG. 12 is a side view of the needle of FIG. 5;[0041]
• FIG. 13 is an end view of the needle of FIG. 5;[0042]
• FIG. 14 is a plan view of the upper jaw of the instrument;[0043]
• FIG. 15 is a side view of the upper jaw of FIG. 14;[0044]
• FIG. 16 is a sectional view of the upper jaw of FIG. 14;[0045]
• FIG. 17 is an end view of the upper jaw of FIG. 14;[0046]
• FIG. 18 is a trocar used in accordance with one embodiment of this invention;[0047]
• FIG. 19 is an expanded view of the distal end of the trocar of FIG. 18;[0048]
• FIG. 20 is an expanded sectional view of the proximal end of the trocar of FIG. 18;[0049]
• FIG. 21 is an expanded view of the distal portion of the trocar of FIG. 19;[0050]
• FIG. 22 is an end view of the trocar of FIG. 18;[0051]
• FIG. 23 is a sectional view of the instrument of FIG. 1 with trocar and needle in place;[0052]
• FIG. 24 is an expanded view of the distal portion of FIG. 23;[0053]
• FIG. 25 shows a needle and trocar loaded and the upper jaw open in preparation for use;[0054]
• FIG. 26 is an expanded view of the distal end of the instrument of FIG. 25;[0055]
• FIG. 27 depicts the instrument grasping tissue in preparation for passing a needle with suture therethrough;[0056]
• FIG. 28 is an expanded view of the distal end of the instrument grasping tissue as shown in FIG. 27;[0057]
• FIG. 29 shows the trocar now advanced so that the needle tip is beginning to pierce tissue grasped between the instrument jaws;[0058]
• FIG. 30 is an expanded view of the distal end of the instrument shown in FIG. 29;[0059]
• FIG. 31 shows the trocar advanced so that the needle has approximately 90 percent penetration of tissue grasped between the instrument jaws;[0060]
• FIG. 32 is an expanded view of the distal end of the instrument shown in FIG. 31;[0061]
• 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;[0062]
• FIG. 34 is an expanded view of the distal end of the instrument of FIG. 33;[0063]
• 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;[0064]
• FIG. 36 is an expanded view of the distal end of the instrument of FIG. 35;[0065]
• FIG. 37 is similar to FIG. 35, but with the trocar retracted so that only the needle and suture remain within the tissue;[0066]
• FIG. 38 is an expanded view of the distal end of the device of FIG. 37;[0067]
• FIG. 39 is similar to FIG. 37, but with the moveable jaw retracted;[0068]
• FIG. 40 is an expanded view of the distal end of FIG. 39;[0069]
• 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;[0070]
• FIG. 42 is an expanded view of the distal end of FIG. 41;[0071]
• FIG. 43 is similar to FIG. 41, but with the needle grasped between the jaws of the instrument;[0072]
• FIG. 44 is an expanded view of the distal end of FIG. 43;[0073]
• FIG. 45 is similar to FIG. 43, but with the needle rotated and grasped between the jaws in preparation for withdrawal through the cannula;[0074]
• FIG. 46 is an expanded view of the distal end of FIG. 45;[0075]
• FIG. 47 is a plan view of an alternate needle configuration according to the invention;[0076]
• FIG. 47[0077]ais a plan view of an alternate suture configuration according to one embodiment of the invention;
• FIG. 48 is a side view of the needle configuration of FIG. 47;[0078]
• FIG. 49 is an end view of the needle configuration of FIG. 47;[0079]
• FIG. 50 is a plan view of yet a further alternate needle configuration according to the invention;[0080]
• FIG. 51 is a side view of the alternate needle configuration of FIG. 50;[0081]
• FIG. 52 is an end view of the alternate needle configuration of FIG. 50;[0082]
• FIG. 53 is a plan view of an alternate top jaw configuration according to the invention;[0083]
• FIG. 54 is a side view of the alternate top jaw configuration of FIG. 53;[0084]
• FIG. 55 is an end view of the alternate top jaw configuration of FIG. 53;[0085]
• FIG. 56 is a sectional view of the alternate top jaw configuration of FIG. 53;[0086]
• FIG. 57 is a sectional view of upper and lower jaws with jaws closed and needle fully extended;[0087]
• FIG. 58 is a sectional view of upper and lower jaws with jaws opened 50 percent and needle fully extended;[0088]
• FIG. 59 is a sectional view of upper and lower jaws with jaws opened 100 percent and needle fully extended;[0089]
• FIG. 60 is a sectional view of upper and lower jaws with jaws opened 100 percent and the suture being pulled through the tissue;[0090]
• FIG. 61 is a plan view of yet a different alternate needle according to the invention;[0091]
• FIG. 62 is a lateral side view of the different alternate needle of FIG. 61;[0092]
• FIG. 63 is an end-on view of the alternate needle of FIG. 61 viewed from the distal tip;[0093]
• FIG. 64 is a plan view of an alternate construction of the upper/moveable jaw;[0094]
• FIG. 65 is a side view of the alternate construction of the upper/moveable jaw of FIG. 64;[0095]
• FIG. 66 is a bottom-side plan view of the alternate construction of the upper/moveable jaw of FIG. 64;[0096]
• FIG. 67 is an end view of the alternate construction of the upper/moveable jaw of FIG. 64 from the proximal end;[0097]
• FIG. 68 is an end view of the alternate construction of the upper/moveable jaw of FIG. 64 from the distal tip;[0098]
• FIG. 69 is a sectional view of the alternate construction of the upper/moveable jaw of FIG. 64 in direction J-J;[0099]
• FIG. 70 Is a sectional view of the alternate construction of the upper/moveable jaw of FIG. 64 in direction K-K;[0100]
• FIG. 71 is a sectional view of the alternate construction of the upper/moveable jaw of FIG. 64 in direction L-L;[0101]
• 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;[0102]
• 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;[0103]
• 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;[0104]
• 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;[0105]
• FIG. 76 is an alternate needle having a radial shape and made of Nitinol;[0106]
• FIG. 77 is a plan view of the needle of FIG. 76 prior to forming;[0107]
• FIG. 78 is an end view of the needle of FIG. 76;[0108]
• FIG. 79 is a plan view of an alternate needle according to the invention;[0109]
• FIG. 80 is a side view of the needle of FIG. 79;[0110]
• FIG. 81 is an end view of the needle of FIG. 79;[0111]
• FIG. 82 is a plan view of an alternate top jaw according to the invention;[0112]
• FIG. 83 is a side view of the alternate top jaw of FIG. 82;[0113]
• FIG. 84 is a side sectional view of the alternate top jaw of FIG. 82;[0114]
• FIG. 85 is an end view of the alternate top jaw of FIG. 82;[0115]
• FIG. 86 is an expanded lateral sectional view of the alternate top jaw of FIG. 82;[0116]
• FIG. 87 is a drawing of a jawless suture punch according to the present invention;[0117]
• FIG. 88 is a drawing of a trocar pusher adapted for use with the jawless punch of FIG. 87;[0118]
• FIG. 89 is a drawing of the distal tip of an angled jaw or jaw-less design according to the present invention;[0119]
• FIG. 90 is a drawing of a particularized capsular plication suture punch for the shoulder according to the present invention;[0120]
• 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;[0121]
• FIG. 92 is a drawing depicted in partial transparent form, illustrating a more sophisticated jawless punch according to the present invention;[0122]
• FIG. 93 is an oblique view of the device of FIG. 92;[0123]
• FIG. 94 is a close-up view of the distal end including the curved tip;[0124]
• FIG. 95 is a side-view of the device of FIG. 93 with the needle loaded in position;[0125]
• FIG. 96 is a perspective-view of the configuration shown in FIG. 95;[0126]
• FIG. 97 is a side-view showing the trocar being advanced by pushing on the proximal end of the pusher rods;[0127]
• FIG. 98 shows the needle being pushed passed the breached loading position, with the suture material extending out from a slot;[0128]
• FIG. 99 shows the needle being deformed and pushed out the distal end;[0129]
• FIG. 100 shows the needle fully advanced, now free of the distal tip of the instrument;[0130]
• FIG. 101 is a close-up, detail view of the needle emerging from the curved distal tip of the instrument;[0131]
• FIG. 102A shows the jaws open ready to grab the tip of the needle;[0132]
• FIG. 102B shows the needle grasped;[0133]
• FIG. 102C shows how, even once grasped, the tip of the needle may rotate within the jaws;[0134]
• FIGS. 103A-103C are side views of the embodiments of FIGS. 102A-102C;[0135]
• FIG. 104 is a perspective view of the grasping mechanism in conjunction with the tip of the needle;[0136]
• FIG. 105A is a first view of a needle according to the invention particularly suited to certain shoulder procedures;[0137]
• FIG. 105B is a different view of the needle of FIG. 105A;[0138]
• FIG. 105C is a end-on view of the needle of the FIGS. 105A and 105B;[0139]
• FIG. 106 is a retrieval instrument associated with the needle of FIG. 105;[0140]
• FIG. 107A is a close-up view drawing of the retrieval tip of the instrument of FIG. 106;[0141]
• FIG. 107B is a different view of the retrieval tip;[0142]
• FIG. 107C is an end-on view of the retrieval tip;[0143]
• FIG. 108 shows a distal portion of an insertion instrument; and[0144]
• 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.[0145]
DETAILED DESCRIPTION OF THE INVENTION
• 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.”[0146]
• 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.[0147]
• Referring to the drawings, as best seen in FIGS. 1 through 9, the[0148]instrument body11 has a proximal end1 and a distal end2. The distal end further includes a fixed portion (or fixed jaw)3 and a movable portion (or moveable jaw)4. Themovable portion4 is rotatable aboutpin5 passing through themovable portion4 and fixedportion3 thereby forming a hinge.
• The position of[0149]movable jaw4 is determined by positioningrod6 which transmits an opening or closing force tomovable portion4 viahinge pin7. The position ofpositioning rod6 is determined by the position ofmovable handle8, which is connected to the proximal end ofpositioning rod6 throughpin9. Thepositioning rod6 passes throughelongated section18 ofinstrument body11 and throughpassage17.
• [0150]Movable handle8 is rotatably affixed to theinstrument body11 bypin10 so that rotatingmovable handle8 counterclockwise opensmovable jaw4 and rotatingmovable handle8 clockwise closesmovable jaw4 with a closure force proportional to that applied betweenmovable handle8 and fixedhandle12. Closure pressure between the jaws may be maintained by a ratcheting action created through the interraction betweentooth section13 ofmovable handle8 andserrations14 onarcuate section15 of fixedhandle12.
• Closure pressure may be released by elastically deforming[0151]arcuate section15 upward with pressure applied toproximal end16 of the arcuate section.Fixed jaw3 andmovable jaw4 may includeserrations8 formed on their angularly transposed surfaces to facilitate the grasping of tissue placed between them.Removable trocar70 protrudes from the proximal end ofinstrument body11.
• As is best seen in FIGS. 11 through 13, one embodiment of the[0152]needle20 has aproximal end21 and adistal end22, and arectangular cross-section27 withupper surface28,lower surface29 and lateral surfaces30. Theproximal end21 includes a contouredproximal surface23, conical in shape in one embodiment, and having a conical angle24 and aconical axis25 coaxial withneedle centerline26. Thedistal end22 is shaped to form acutting edge28 having includedangle27.Suture31 is connected to aneedle lateral surface30 at adistance32 from the needle proximal end.
• As is best seen in FIGS. 4, 5,[0153]9, and10, theinstrument body11 has acontinuous passage40 of varying cross-section extending from theproximal-most face41 ofinstrument body11 to theupper surface42 of fixedjaw3 near the jaw's distal tip. Insection43, extending adistance44 fromproximal face41, the passage has a cylindrical cross-section of a specifieddiameter56 as shown in FIGS. 7 and 8. Insection45, extending adistance46 from the distal end ofsection43, the passage is arectangular channel44, the height of thechannel51 being slightly greater than thethickness45 ofneedle20.Distance46 is sufficiently longer than the length ofneedle20 to allow easy placement of the needle in the slot.
• [0154]Section47 of the slot extends from the distal end ofsection45 to the termination of the slot at thetop surface42 of fixedjaw3 and beneficially includes of alinear portion48 and aradial portion49 having a knownradius50. As is best seen in FIG. 5, the cross-section ofchannel40 insection47 is rectangular having aheight51 slightly greater than thethickness45 ofneedle20 and awidth52 slightly greater thanwidth53 ofneedle20. Aslot54 having aheight55 less thanheight51 ofpassage40 extends through the entirety ofsection47.
• As is best seen in FIGS. 14 through 17,[0155]upper jaw4 contains a shapedpassageway60 having awidth61 slightly larger thanwidth52 ofpassage40 and extending from the jaw'slower surface63 toupper surface64. As best seen in FIGS. 4 and 10,upper jaw4 protrudes distally adistance62 beyondlower jaw3.
• Referring to FIGS. 18 through 22, the force-supplying mechanism is a[0156]trocar70 that is an assembly including a steppedcylindrical rod71 andhub72 and having adistal end73 andproximal end74, with the hub being attached toproximal end74. Stepped metalliccylindrical rod71 features alarger diameter section75 of specifiedlength76 anddiameter77, with the diameter being slightly smaller thandiameter56 ofsection43 ofpassage40 so allowingtrocar70 may move freely withininstrument body11 when inserted intopassage40.Cylindrical rod71 has asmaller diameter section78 of specifiedlength79 anddiameter80, with the diameter being slightly smaller thanheight51 ofsections45 and47 ofpassage40 allowingtrocar70 to move freely withinelongated section18 ofinstrument body11 when inserted intopassage40.Rod71 is hardened throughout its length to prevent bending, exceptsection81 extending alength82 fromdistal tip73 is annealed for high malleability.Distal tip73 is formed to a conical shape ofconical angle83, with the conical angle being equal to conical angle24 onproximal end21 ofneedle20.
• Referring to FIGS. 23 and 24, when prepared for use,[0157]needle20 is inserted laterally intosection45 ofpassage40 with thelateral surface30 withsuture31 facing the open side ofchannel40 andsuture31 extending fromelongated section18 ofbody11. After insertion,needle20 is moved distally tosection47 ofchannel40;trocar70 is inserted intochannel40 ofinstrument body11, and positioned as shown in FIGS. 23 and 24.
• Referring to FIGS. 25 and 26, when using the instrument to pass a suture the[0158]movable jaw4 is opened usingmovable handle8.Trocar70 is inserted intoinstrument body11 until trocardistal end73 engages needleproximal end21.Suture31 carried by theneedle20 moves freely inslot54.
• During use of the device, as seen best in FIGS. 27 and 28, tissue is grasped between[0159]upper jaw4 andlower jaw3. Referring to FIGS. 29 and 30, advancing trocar70 adistance85 distally causes needle20 to move distally inchannel20, the distal portion of the needle being formed to aradius50 by theradial portion49 ofpassage40.
• Referring to FIGS. 31 and 32, advancing the trocar an[0160]additional distance86 causes needle20 to be formed to a radial shape ofradius87,radius87 being larger thanradius50 ofsection49 ofpassage40 due to spring back of the needle after leaving the passageradial section49.Needle20 follows a radial path through the tissue. Advancingtrocar70 an additional distance88 (see FIGS. 33 and 34) causesneedle20 to advance along its radial path until needle distal tip protrudes abovetop surface64 ofmovable jaw4, having passed throughjaw4 viapassage60.
• As is best seen in FIGS. 35 and 36, advancing[0161]trocar70 distally untilhub72 contactsdistal face41 ofinstrument body11 advances needle20 further through the tissue, withdistal tip73 oftrocar70 assuming a radial shape ofradius87 as it passes throughradial portion49 ofpassage40. Alignment between trocardistal tip73 and needleproximal end21 is maintained by engagement of the needle proximal end conical recess with the with the trocar distal tip conical protrusion, needle proximal end conical radius24 and trocar distal tipconical radius83 being equal. In this manner,needle20 andsuture31 are advanced adistance89 into the tissue beyond the top surface oflower jaw3.
• As is best seen in FIGS. 37 and 38, withdrawing trocar[0162]70 adistance90 causes the trocardistal tip73 to be withdrawn from the tissue into the distal portion ofpassage40, leavingneedle20 andsuture31 in the tissue, with needledistal tip22 protruding well above the top surface ofupper jaw3. As seen in FIGS. 39 and 40,upper jaw3 is now retracted withneedle20 moving freely withinpassage60. Referring now to FIGS. 41 and 42, withdrawing the instrument axially causesneedle20 inslot60 ofupper jaw3 to be pulled free from the tissue withsuture31 now passing through the tissue. Referring to FIGS. 43 and 44, closingjaw3 causes it to graspneedle20 thereby allowing further retraction of the needle and the suture. As seen in FIGS. 45 and 46,jaws3 and4 may be opened thereby freeingneedle20, and the needle rotated 90 degrees and re-grasped byjaws3 and4.
• Although the above description references “[0163]needle20,” various other needle designs are equally applicable to the invention. In another embodiment, shown in FIGS. 47 through 49,needle92 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. 47a,the suture material may be looped back into theneedle92 such that when theneedle92 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.
• In another embodiment, shown in FIGS. 50 through 52,[0164]needle94 has a non-uniform cross-section, upper andlower surfaces95 and96 having a plurality ofangled surface segments98 ofangle95 each surface terminating in aradius96 so as to form a series of notches useful in engaging corners ofpassage60 inupper jaw3 so as to aid in needle retraction during axial withdrawal of the instrument.
• 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,[0165]upper jaw100 is of similar construction toupper jaw3 except thatpassage60 has been replaced withslot101. As is best seen in FIGS. 57 through 59, thedistal protrusion62 ofupper jaw4 beyondlower jaw3 is required to allowneedle20 to enterpassage60 throughout the range of positions ofupper jaw4. FIG. 60 is a sectional view of upper and lower jaws with jaws opened 100 percent and the suture being pulled through the tissue.
• A further[0166]alternate needle201 is shown in FIGS. 61 through 63. As is best seen in FIG. 62, the needle ofthickness220 has adistal end202 and aproximal end203, with the distal end formed to a wedge shape having includedangle204 so as to form acutting edge205. Theproximal end203 has aconical shape206 formed therein and having an angle207 equal toangle83 on the distal tip oftrocar70 shown in FIGS. 18 through 22. As is best seen in plan view FIG. 61,needle201 has three sections distinguished by their width.Proximal section208 anddistal section209 have awidth210, whilemedial section211 has a width of212 thanwidth211.Distal section209 is not of constant width, but rather tapers to awidth213 at its distal tip. The transition frommiddle section211 toproximal section208 is a taper oflength214 andangle215.Suture216 is connected tolateral surface217 of proximal section208 adistance218 fromproximal end203.
• An alternate upper jaw to be used in conjunction with[0167]alternate needle201 is shown in FIGS. 64 through 71. As is best seen in FIGS. 64, 66 and68,upper jaw110 is constructed likeupper jaw4 having adistal end111 and aproximal end112, except thatupper jaw110 has adistal end slot113, the distal slot having aproximal portion114 and adistal portion120, and the portions being distinguished by their width.Proximal portion114 has alength125 and awidth115 which is slightly larger thanwidth210 ofproximal section208 anddistal section209 ofneedle201 as shown in FIG. 61.Distal portion120 has a width of121 which is slightly larger thanwidth212 ofmiddle section211 ofneedle201 shown in FIG. 61.
• As is best seen when viewing[0168]jaw110 laterally as in FIG. 65,distal portion111 ofjaw110 has a hookedportion126 formed therein, the hooked portion having aradius127 and aheight128,height128 being somewhat larger thanthickness220 ofneedle201 as seen in FIG. 62. As is best seen in axial sectional view FIG. 71,proximal portion114 ofslot113 has aportion130 ofheight131 with parallel sides and aportion132 ofheight133 whose lateral facing sides are angled outward atangle134 so that the bottom of the slot is wider than the top of the slot.
• The functioning of[0169]alternate needle201 andalternate jaw110 is best seen in FIG. 72 through75. Functioning of the needle and jaw are as explained previously except, referring to FIG. 72,needle201 being of a shorter length than that ofneedle20 andtrocar170 being of a shorter length thantrocar70, whentrocar70 is fully inserted to the limit of its travel, the portion ofneedle201 remaining withintissue171 is greater than that remaining in the previously explained embodiments. Thelength175 of the portion ofneedle201 protruding beyondtissue171 is sufficient to cause the distal end ofmedial portion211 ofneedle201 to extend abovesurface172,needle201 having passed throughproximal portion114 ofslot113, and, as shown in FIG. 72 passed intodistal portion120 ofslot113 due to movement of the instrument proximally.
• In this embodiment,[0170]needle201 is prevented from disengagement from thedistal portion120 ofslot113 because thewidth210 of needledistal portion209 is greater thanwidth121 of slotdistal portion120.Needle201 is able to move freely withinslot113 parallel to the axis of the slot aswidth212 of needlemedial portion211 is less thanwidth121 ofdistal portion209 ofslot113. Referring to FIG. 73, withdrawing the instrument proximally causesneedle201 to move distally and pivot withindistal portion120 ofslot113 so as to engage with thehook segment126 ofjaw110, thereby allowingneedle201 to be extracted fromtissue171, causingsuture216 to be pulled through the tissue. As is best seen in FIG. 74, afterneedle201 is free oftissue171upper jaw110 may be closed and additional suture pulled through the tissue. As seen in FIG. 75,jaw110 may be closed totally thereby allowingneedle201 andsuture216 to be withdrawn through a cannula.
• An alternate needle made of Nitinol and formed to a radial shape during manufacture is shown in FIGS. 76 through 78. Manufacture of[0171]needle400 is accomplished in two steps, namely the cutting of the needleblank profile401 from sheet material, and forming of the needle to ashape having radius402, withradius402 being equal to formingradius50 oflower jaw3 as shown in FIG. 10.Needle400 may be used in the same manner as previous embodiments as it will be constrained in a straightened state by channel47 (FIG. 9) prior to deployment. Needle capture and retrieval are accomplished in the same manner asneedle201 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 thelower jaw3. 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.
• An[0172]alternate needle500 having multiple “barbs” displaced along its lateral surfaces is shown in FIGS. 79 through 81. The needle features adistal end501 shaped to acutting edge506 having includedangle507, and aproximal end502 having a convexconical shape503 withconical angle504. The conical angle is, in one embodiment, equal todistal tip angle83 oftrocar70, shown in FIG. 21.Suture508 is attached to a lateral face510 a distance511 fromdistal end502.Needle500 has awidth507 and a number of pyramid-shaped “barbs”512 displaced alonglateral surfaces510, thelateral distance513 between barb tips being greater thanwidth507. The barb protrusions are pyramidal in shape having alength514,width515 andheight516, the distal edge517 forming anangle518 with thelateral surface510.
• FIGS. 82 through 86 show an alternate upper jaw for use with[0173]needle500.Jaw600 in constructed in the manner ofjaw4, except thatjaw600 includes a hollow structure ofwall thickness602 forming acapture space601. Thecapture space601 is defined by the walls of the jaw and by theinner surface603 of the jawlower wall604. Jawlower wall604 has aslot605 of width606, width606 being greater thanwidth507 ofneedle500, but less thandistance513 between barb tips ofneedle500. The lower section ofslot605 is tapered outward so as to aidneedle500 in enteringslot605.
• [0174]Needle500 andupper jaw600 are used in the same manner as needle and jaw configurations previously disclosed; that is,needle500 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.Needle500 andjaw600 vary in the method of capture.Distal tip501 ofneedle500 entersslot605 ofjaw600, and via the slot entersspace601.Slot605, being less in width thandistance513 between the needle barb tips, causes the barb tips to deform as they pass intospace601 viaslot605. Also, becausewall thickness602 is rather thin,jaw600 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.
• 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.[0175]
• 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[0176]distal end802, and aproximal end804 including aninsertion point806. 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 tip812 coupled to a blunt814 through aneyelet816 to receive a thread or suture loop. In operation, thecurved tip802 is placed next to tissue to be sutured, and the sharp tip inserted into theinsertion point806. 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.
• 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[0177]loading slot820 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 downtrocar channel822. As the flexible tip of the trocar nears theneedle slot820, 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 at902. 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 thesurface902. 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 separateneedle capture mechanism910 may be used to pull the suture through, as described elsewhere herein.
• 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[0178]920 includes a body portion having asqueeze handle922 coupled to aratchet924 which engages withbarbs926 on a pusher mechanism. The pusher mechanism extends through the barrel of the instrument down to thedistal tip930, which terminates in acurved portion932, and includes abreach loading slot934 to receive aneedle940 attached to suture941 and including adistal tip942 configured for grasping. FIG. 93 is an oblique drawing of the device of FIG. 92. FIG. 94 is a close-up view drawing of thedistal end930 includingcurved tip932,breach loading slot934 andspecialized needle940 having atip942 configured for manual grasping, theneedle940 being attached at its proximal end tosuture material941. 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, ashandle922 is compressed, causing theratchet924 to advance thebarbs926 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.
• 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[0179]mechanism1002 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.
• Yet a further embodiment, intended for applications such as the repair of tom 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.[0180]
• 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.[0181]
• 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.[0182]
• Referring to the drawings, as best seen in FIGS. 105A through 105C,[0183]needle2001 of width W₁(2004) and height H₁(2005) has adistal end2002 and aproximal end2003. Amiddle region2009 having a width W₂(2006) forms “shoulders”2012 at itsdistal end2002 which is sharpened. Asuture2007 is attached to lateral surface2008 a distance L₁(2010) fromdistal-most surface2011.
• Referring to FIG. 106,[0184]retrieval instrument2020 has aproximal portion2021 formed to a handle shape and an elongateddistal portion2022 terminating indistal tip2023. Referring to FIGS. 107A through 107C,distal tip2023 has aslot2024 of width W₃(2025) which is slightly larger than width W₂(2006 in FIG. 105A) but less than W₁(2004). The profile ofdistal end2023 has adistal surface2026 inclined at an angle A₁(2027) and acapture region2028 bounded on its distal end by hook-shapedsurface2029 and on its proximal end bylateral surface2030 displaced from surface2029 a distance L₂(2031) andsurface2032.
• FIG. 108 shows the[0185]distal portion2040 of an insertion instrument of this embodiment.Needle2001 is positioned in the formingchannel2047 andsuture2007 is affixed to the needle.Distal portion2040 has two radii, R₁(2041) and R₂(2042) which together displace forming channel2045 a distance D₁(2046). Radius R₂(2042) forms the needle to a radial shape having a radius R₃(2049 in FIG. 109C) slightly larger than R₂(2042). A normal todistal-most surface2048 is coaxial with the axis of the axis ofportion2040.
• Referring to FIG. 109A,[0186]tissue43 is to be sutured totissue2044. In FIG. 109B, the “tear” is closed by applying force totissue2043 usingdistal portion2040. In FIG. 109C,needle2001 has been inserted in the same manner as in the previous embodiment. In FIG. 109D, the insertion instrument has been removed andneedle2001 remains in place withsuture2007. In FIG. 109E,retrieval instrument2020 has been brought into position. FIG. 109F,distal tip2023 has been inserted such thatneedle2001 is engaged inslot2024 and surface2026 (see FIG. 107B) acting on shoulders2012 (FIG. 105A) ofneedle2001 has displaced the needle distally intissue2043 and2044.
• Referring to FIG. 109G,[0187]distal end2002 ofneedle2001 is captured in region20028 (FIG. 107B). Displacingretrieval instrument2020 distally (FIG. 109H) causesneedle2001 to be extracted fromtissue2043 thereby pullingsuture2007 through the tissue. In FIG. 109I additional suture has been pulled through the tissue. In FIG. 109J,retrieval instrument2020 has been moved proximally causingneedle2001 to pivot indistal tip2023. In FIG. 109K,needle2001 has pivoted into position for retrieval through a cannula.
• 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.[0188]

Claims (40)

We claim:

1. Suturing instrumentation for suturing tissue comprising:

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 configured 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.

2. The suturing instrumentation ofclaim 1, wherein the handheld instrument includes a proximal insertion opening to receive the distal end of the force-supplying structure.

3. The suturing instrumentation ofclaim 1, wherein the distal end of the handheld instrument includes an elongated slot to receive the malleable needle portion from the side,

the slot transitioning to a narrower slit along the nonlinear portion, enabling the suture material to extend from the slit as the needle portion is pushed through the nonlinear portion.

4. The suturing instrumentation ofclaim 1, wherein the malleable needle portion has a degree of spring back of from 0 to about 100 percent.

5. The suturing instrumentation ofclaim 4, wherein the malleable needle portion has a degree of spring back of from 0 to about 10 percent.

6. The suturing instrumentation ofclaim 4, wherein the malleable needle portion has a degree of spring back of from about 90 to about 100 percent.

7. The suturing instrumentation ofclaim 1, wherein the malleable needle portion comprises a Nitinol needle.

8. The suturing instrumentation ofclaim 7, wherein the Nitinol needle is formed into a curved shape having a radius substantially equal to the first radius, further wherein the Nitinol needle is forcibly straightened when located in the handheld instrument and substantially regains the curved shape after leaving the handheld instrument.

9. The suturing instrumentation ofclaim 7, wherein the Nitinol needle is substantially linear in shape, further wherein the Nitinol needle is forcibly curved when forced through the nonlinear portion of the handheld instrument and substantially regains the linear shape after leaving the handheld instrument.

10. Suturing instrumentation for suturing tissue comprising:

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 configured 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.

11. The suturing instrumentation ofclaim 10, wherein the jaw includes an aperture, slot, or cavity to receive the deformed needle portion.

12. The suturing instrumentation ofclaim 10, wherein the handheld instrument includes a proximal insertion opening to receive the distal end of the force-supplying structure.

13. The suturing instrumentation ofclaim 10, wherein the distal end of the handheld instrument includes an elongated slot to receive the malleable needle portion from the side,

the slot transitioning to a narrower slit along the nonlinear portion, enabling the suture material to extend from the slit as the needle portion is pushed through the nonlinear portion.

14. The suturing instrumentation ofclaim 10, wherein the malleable needle portion has a degree of spring back of greater than 0 to about 100 percent.

15. The suturing instrumentation ofclaim 14, wherein the malleable needle portion has a degree of spring back of greater than 0 to about 10 percent.

16. The suturing instrumentation ofclaim 14, wherein the malleable needle portion has a degree of spring back of from about 90 to about 100 percent.

17. The suturing instrumentation ofclaim 10, wherein the malleable needle portion comprises a Nitinol needle.

18. The suturing instrumentation ofclaim 17, wherein the Nitinol needle is formed into a curved shape having a radius substantially equal to the first radius, further wherein the Nitinol needle is forcibly straightened when located in the handheld instrument and substantially regains the curved shape after leaving the handheld instrument.

19. The suturing instrumentation ofclaim 17, wherein the Nitinol needle is substantially linear in shape, further wherein the Nitinol needle is forcibly curved when forced through the nonlinear portion of the handheld instrument and substantially regains the linear shape after leaving the handheld instrument.

20. The suturing instrumentation ofclaim 10, further including a manually operated control enabling a user to open and close the jaw.

21. A suture needle adapted for use with a handheld instrument defining an axis and having an off-axis distal end, the needle comprising:

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.

22. The suture needle ofclaim 21, wherein the length of material includes one or more flat sides to resist rotation as the needle passes through the off-axis portion of the handheld instrument.

23. The suture needle ofclaim 22, wherein the length of material includes opposing flat sides.

24. The suture needle ofclaim 21, wherein the length of material includes one or more indented portions to assist with deformation as the needle passes through the off-axis portion of the handheld instrument.

25. The suture needle ofclaim 21, wherein the length of the needle is about 15 mm or less.

26. A suturing system comprising:

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.

27. The suturing system ofclaim 26, wherein the needle portion is substantially straight when in at least a portion of the passageway, curved when in the distal end, and curved upon exiting the distal end of the handheld instrument.

28. The suturing system ofclaim 26, wherein the needle portion is substantially straight when in at least a portion of the passageway, curved when in the distal end, and substantially straight upon exiting the distal end of the handheld instrument.

29. The suturing system ofclaim 26, wherein the malleable needle portion has a degree of spring back of greater than 0 to about 100 percent.

30. The suturing system ofclaim 29, wherein the malleable needle portion has a degree of spring back of greater than 0 to about 10 percent.

31. The suturing system ofclaim 29, wherein the malleable needle portion has a degree of spring back of from about 90 to about 100 percent.

32. The suturing system ofclaim 26, wherein the malleable needle portion comprises a Nitinol needle.

33. A method for suturing, comprising the steps of:

providing a malleable needle portion having a sharpened distal tip;

positioning the needle portion 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.

34. The method ofclaim 33, wherein the handheld instrument has a distal end terminating in a nonlinear portion, and the needle portion is deformed as it traverses the nonlinear portion.

35. The method ofclaim 33, wherein the needle portion is substantially straight when in at least a portion of the passageway of the handheld instrument, curved when in the distal end, and curved upon exiting the distal end of the handheld instrument.

36. The method ofclaim 33, wherein the needle portion is substantially straight when in at least a portion of the passageway of the handheld instrument, curved when in the distal end, and substantially straight upon exiting the distal end of the handheld instrument.

37. The method ofclaim 33, wherein the malleable needle portion has a degree of spring back of greater than 0 to about 100 percent.

38. The method ofclaim 37, wherein the malleable needle portion has a degree of spring back of greater than 0 to about 10 percent.

39. The method ofclaim 37, wherein the malleable needle portion has a degree of spring back of from about 90 to about 100 percent.

40. The method ofclaim 33, wherein the malleable needle portion comprises a Nitinol needle.

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