Abstract
A suture manipulating instrument for passing and retrieving suture through a tissue includes a handle mechanism, an elongate shaft extending from the handle, and a working distal end. The working distal end includes a needle body, a lumen defined by the needle body, a tissue penetrating distal tip, and a lateral slot. A preformed inner member is movably disposed within the lumen of the needle. The handle mechanism is used to extend the wire from the lateral slot of the needle, and to retract the wire into the lateral slot, allowing the working end of the instrument to grasp and manipulate suture by pinning and/or trapping the suture against the needle. In embodiments the inner member is further retracted within the needle lumen, drawing a length of suture into the needle lumen. The suture is subsequently ejected from the needle lumen to form a suture loop.
Claims
1. An instrument for manipulating and passing suture through a tissue, said instrument comprising: a handle end and a needle extending distally therefrom, the needle having a lumen extending therethrough, a distal tip, and an opening in communication with said lumen and the distal tip; and an inner member movably disposed within said lumen, said inner member including a book defined by a plurality of discrete bends and wherein the inner member is movable from a first retracted configuration in which at least a portion of the hook is situated within the lumen, and an extended configuration in which the hook extends from the opening; and wherein a distal section of the inner member has a preformed shape which directs the hook laterally away from a needle axis as the inner member moves towards the extended configuration, said needle axis extending through the needle towards the needle distal tip; and wherein the inner member distal section defines a first length having a first stiffness along a first bend and a second length extending from the first length and including the hook having a second stiffness, greater than the first stiffness distal to the first length; the first length configured so that the first bend may elastically deform while moving between the first retracted configuration and the extended configuration, and the second length, configured so that the hook resists deformation so as to maintain hold of the suture while manipulating the suture; and wherein the distal section of the inner member and the needle are configured to cooperate together to: (a) engage a suture disposed therebetween when the inner member is in the first retracted configuration, and (b) urge the clamped suture away from the suture instrument when the inner member is moved towards the extended configuration.
2. The instrument of claim 1 wherein the first length has a first cross sectional area and the second length has a second cross sectional area, and the first cross sectional area is smaller than the second cross sectional area.
3. The instrument of claim 1 wherein the hook of the inner member has a shape selected from the group consisting of a crochet hook, crescent curve, dogleg curve, and box hook.
4. The instrument of claim 1 wherein the distal section of the inner member and the needle are configured to cooperate together to engage a suture disposed therebetween when the inner member is in the first retracted configuration such that the suture is slideably encircled.
5. The instrument of claim 1 wherein the distal section of the inner member and the needle are configured to cooperate together to engage a suture disposed therebetween when the inner member is in the first retracted configuration such that the suture is pinned.
6. The instrument of claim 1 wherein the distal section of the inner member and the needle cooperate together to further draw the suture into the lumen so as to be proximally spaced from the entire opening subsequent to the engaging.
7. The instrument of claim 1 wherein the hook of the inner member is defined by three discrete curves defining a trapezoidal shaped cavity.
8. The instrument of claim 7 wherein a tip of the hook and a proximal-most curve of the three discrete curves both engage an inner surface of the needle lumen when in the first retracted configuration so as to enclose the trapezoidal shaped cavity with a length of the needle inner surface.
9. The instrument of claim 7 wherein a first and a second of the three discrete curves define a depth of the hook, the depth extending across a diameter of the needle lumen.
10. The instrument of claim 7 wherein the distal-most curve of the three discrete curves aims a tip of the hook proximally.
11. A suture instrument for manipulating and passing suture through a tissue, said instrument comprising: a handle and a needle extending distally therefrom; the needle end defining a lumen extending therethrough, a distal tip, and a laterally disposed opening along the needle end and in communication with said lumen; and an inner member movably disposed within said lumen of said needle, between a first retracted configuration in which at least a portion of a distal section of the inner member is situated within the opening of the needle, a second retracted configuration in which a distal-most tip of the inner member is axially spaced away from the opening, and an extended configuration in which the distal section of the inner member extends from the opening of the needle; and wherein the distal section of the inner member has an engineered shape comprising a first curve which guides a hook of the inner member laterally away from a needle axis as the inner member moves towards the extended configuration, said axis extending through the needle towards the distal tip of the needle; wherein the hook is defined by a plurality of discrete curves and wherein the inner member first curve has a first stiffness, and the hook has a second stiffness, greater than the first stiffness so as to resist deformation of the hook portion during suture manipulation.
12. The suture instrument of claim 11 wherein the hook and the needle are configured to cooperate together to clamp a suture disposed therebetween when the inner member is in the first retracted configuration, and to eject the suture from the opening when the inner member is in the extended configuration.
13. The suture instrument of claim 11 further comprising a lever movably disposed in said handle and linked to the inner member to manipulate the inner member between the first retracted configuration, the second retracted configuration and the extended configuration.
14. The suture instrument of claim 11 wherein the distally disposed hook defines a trapezoidal shaped suture grasping cavity, defining a single opening that is covered by the lumen in the retracted configuration and thereby defining a trapezoidal shaped suture grasping cavity having a boundary including both the hook and lumen.
15. The instrument of claim 11 wherein the engineered shape is elastically deformed while disposed within the needle and reverts towards the engineered shape as the first curve extends from the opening, guiding the inner member laterally away from the needle as the inner member moves towards the extended configuration.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) FIG. 1 is a perspective view of a suture manipulating instrument holding a suture;
(2) FIGS. 2-3 are perspective and cross sectional views respectively of the working end of a suture manipulating instrument in a retracted configuration;
(3) FIGS. 4-5 are perspective and cross sectional views respectively of the working end of a suture manipulating instrument in an extended configuration;
(4) FIGS. 6-7 are perspective and cross sectional views respectively of the working end of a suture manipulating instrument in a suture grasping configuration;
(5) FIGS. 8-18 are illustrations of a surgical instrument manipulating and passing suture through tissue;
(6) FIGS. 19a-19b are perspective views of the working end of another suture manipulating instrument in an extended configuration and a suture grasping configuration respectively;
(7) FIGS. 20a-20b are perspective views of the working end of another suture manipulating instrument in an extended configuration and a suture grasping configuration respectively;
(8) FIGS. 21a-21b are perspective views of the working end of another suture manipulating instrument in an extended configuration and a suture grasping configuration respectively;
(9) FIGS. 22a-22d are partial side views of suture manipulating instruments having various needle slot configurations;
(10) FIGS. 23a-23c are partial side views of suture manipulating instruments having various wire configurations;
(11) FIGS. 24a-24b are side and cross sectional views respectively of the working end of a suture manipulating instrument in a retracted configuration;
(12) FIG. 25 is a cross sectional view of the working end of another suture manipulating instrument in an extended configuration;
(13) FIG. 26 is a perspective view of the working end of another suture manipulating instrument in an extended configuration;
(14) FIGS. 27a-27b are perspective and side views respectively of the working end of another suture manipulating instrument in an extended configuration;
(15) FIGS. 27c-27d are side and cross sectional views respectively of the working end of the suture manipulating instrument shown in FIGS. 27a-27b in a suture grasping configuration;
(16) FIGS. 28a-28b are side views of the working end of another suture manipulating instrument in an extended configuration and a suture grasping configuration respectively;
(17) FIG. 28c is an enlarged cross sectional view of the suture instrument holding the suture shown in FIG. 28b;
(18) FIGS. 29a-29b are side and perspective views respectively of the working end of another needle distal section and inner member in an extended configuration;
(19) FIGS. 30a-b are side and perspective views respectively of the working end of another needle distal section and inner member in an extended configuration;
(20) FIG. 30c is a side view of the working end of another needle distal section and inner member in an extended configuration;
(21) FIG. 31a is a side view of the working end of another needle distal section and inner member in an extended configuration having a proximal undercut;
(22) FIG. 31b is a side view of the working end of another needle distal section and inner member in an extended configuration having a distal undercut;
(23) FIG. 31c is a perspective view of the working end of another needle distal section and inner member in an extended configuration having a distal undercut;
(24) FIGS. 32a-32b are perspective and side views respectively of the working end of another needle distal section and inner member in a retracted configuration;
(25) FIG. 32c is a cross sectional view of the needle distal section and inner member shown in FIG. 32b;
(26) FIGS. 33a-b are top and cross sectional views respectively of the working end of another needle distal section and inner member in an extended configuration;
(27) FIG. 33c is a cross sectional view of the needle distal section and inner member shown in FIG. 33b shown in a retracted configuration;
(28) FIG. 34a is a perspective view of the working end of another needle distal section and inner member shown in a retracted configuration;
(29) FIGS. 34b-34c are various cross sectional views of the needle distal section and inner member shown in FIG. 34a;
(30) FIG. 35a is a perspective view of the working end of another needle distal section and inner member shown in a retracted configuration;
(31) FIGS. 35b-35c are various cross sectional views of the needle distal section and inner member shown in FIG. 35a;
(32) FIG. 35d is an enlarged view of a distal portion of the needle and inner shown in FIG. 35c;
(33) FIG. 36a is a perspective view of the working end of another needle distal section and inner member shown in a retracted configuration;
(34) FIGS. 36b-36c are various cross sectional views of the needle distal section and inner member shown in FIG. 36a;
(35) FIGS. 37-38 are perspective and cross sectional views respectively of the working end of a suture manipulating instrument in a suture grasping configuration;
(36) FIGS. 39-40 are perspective and cross sectional views respectively of the needle distal section and inner member shown in FIG. 37, in a retracted configuration;
(37) FIG. 41 is a perspective view of the needle distal section, suture, and inner member in an extended configuration;
(38) FIGS. 42a-42b are side and perspective views respectively of various needle distal sections in retracted configurations;
(39) FIGS. 43-44 are perspective and cross sectional views respectively of another needle distal section and inner member shown in an extended configuration;
(40) FIG. 45 is a perspective view of the needle distal section, suture, and inner member of FIGS. 43-44, shown in an extended configuration;
(41) FIGS. 46a-46b are side and perspective views respectively of various needle distal sections and inner members shown in extended configurations;
(42) FIG. 47 is a perspective view of another needle distal section, suture, and inner member shown in an extended configuration;
(43) FIGS. 48-49 are perspective and cross sectional views respectively of the working end of a suture manipulating instrument in a suture grasping configuration;
(44) FIG. 50 is a side view of the working end of the suture manipulating instrument shown in FIGS. 48-49, in a further retracted configuration;
(45) FIG. 51a is a cross sectional view of the needle distal section, suture, and inner member shown in FIG. 50, pushing the suture distally;
(46) FIG. 51b is an enlarged view of the inner member gripping into the suture;
(47) FIG. 51c is a perspective view of the needle distal section, suture, and inner member shown in FIG. 50, in an extended configuration;
(48) FIG. 52 is an illustration of a surgical instrument manipulating passing suture through tissue;
(49) FIGS. 53-54 are side views of other needle distal sections and inner members in extended configurations;
(50) FIG. 55 is a side view of another needle distal section and inner member shown in an extended configuration;
(51) FIGS. 56a-56b are side and front views respectively of the inner member shown in FIG. 55;
(52) FIG. 57 is a side view of another needle distal section and inner member shown in an extended configuration;
(53) FIGS. 58a-58b are side and front views respectively of the inner member shown in the needle of FIG. 57;
(54) FIG. 59a is a side view of another needle distal section and inner member shown in an extended configuration;
(55) FIG. 59b is a side view of the inner member shown in the needle of FIG. 59a;
(56) FIGS. 60a-60b are side and front views respectively of another needle distal section and inner member in extended configurations;
(57) FIGS. 60c-60d are side and front views respectively of the inner member shown in the needle of FIGS. 59a-59b;
(58) FIG. 60e is a side view of another inner member having an elongate distal section;
(59) FIG. 60f is a side view of another inner member having a dog leg shaped distal section;
(60) FIGS. 61a-61c are cross sectional views of the needle distal section and inner member shown in FIGS. 59a-59b, cooperating together to grab and draw a suture into the lumen of the needle; and
(61) FIG. 62 is a side view of another needle distal section and inner wire member in an extended configuration.
DETAILED DESCRIPTION
(62) Before the present invention is described in detail, it is to be understood that this invention is not limited to particular variations set forth herein as various changes or modifications may be made to the invention described and equivalents may be substituted without departing from the spirit and scope of the invention. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims made herein.
(63) Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events. Furthermore, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
(64) All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail).
(65) Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. It is also to be appreciated that unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
(66) A surgical instrument 100 for manipulating and passing suture is shown in FIG. 1. The instrument 100 comprises a handle 1, a lever, slide, or button 2, an elongate shaft 3, and a working end 4. Slide 2 controls the suturing manipulating mechanism at the working end 4, as will described herein.
(67) The instrument may be used to pass and/or retrieve suture through tissue in a wide variety of applications including, for example, labrum or rotator cuff repair.
(68) A detailed view of one possible configuration of the working end 4 is shown in FIGS. 2 and 3. The working end 4 is shown having a needle 5 and an inner member 6 (shown in a retracted state). The needle 5 has a laterally disposed suture slot 7 and a needle point or tissue penetrating distal tip 8. Needle point 8 may be formed variously, such as for example, a bevel 9 as shown in FIG. 2.
(69) The suture slot 7 is preferably configured in such a manner to facilitate suture grasping when suture is pinned or clamped between the inner member 6 and the walls of the needle 5.
(70) In the configuration shown in FIGS. 2-3, the suture slot 7 has a distal ramp 7a, a vertical wall 7b, and a wire relief slot 7c. As discussed herein, features 7a and 7b can have different configurations of vertical and/or ramp walls. Additionally, the needle point 8 can be used to facilitate tissue puncturing.
(71) FIGS. 4 and 5 show inner member 6 in an extended or deployed state with a suture 10 lying within the suture slot 7 of needle 5. In the embodiment shown, a single proximal bend 11 is preformed in the inner member 6 proximal to the inner member tip 12.
(72) The inner member may be formed in such a manner that causes its tip 12 to move away from the needle 5 as the inner member 6 is deployed. This action creates space (e.g., a suture capture zone) between the inner member 6 and needle 5 to allow the suture 10 to slide in between the inner member 6 and needle 5. Inner member is shown in this embodiment as a wire member. However, the inner member may be fabricated from other materials and take other forms. For example, inner member may be a metal or alloy filament, braid, or wire bundle comprising one or more elements. A preferred material is super elastic materials such as Nitinol.
(73) The inner wire 6 is retracted once the suture 10 is properly positioned between the inner wire 6 and needle 5. Interaction between the proximal bend 11 on inner wire 6 and the suture slot 7 results in the inner wire tip 12 being displaced toward the needle axis and subsequently traps the suture 10.
(74) FIGS. 6 and 7 show the inner wire 6 in the retracted state with a suture 10 clamped or pinned across the suture slot 7. In this embodiment the suture 10 is forced into a circuitous or tortuous path 13 between the inner wire 6 and the suture slot 7 which increases the hold on the suture 10.
(75) Procedure
(76) FIGS. 8 to 13 show one possible method of using the current embodiment to pass suture from one side of tissue 14 to the other. Examples of tissue include without limitation labral tissue. FIG. 8 shows the instrument with the inner member 6 in the extended or deployed state and in position to grab suture.
(77) The device is then manipulated to position the suture 10 between the inner wire 6 and the suture slot 7 as shown in FIG. 9. In particular, a section of the suture 6 rests in a recess or suture capture zone 7d formed in the walls 7e, 7f of the needle 5.
(78) The inner wire 6 is then retracted thereby clamping, pinning or trapping the suture 10 between the inner wire 6 and the needle 5 as shown in FIG. 10.
(79) FIG. 11 shows piercing the tissue using the needle tip 8, thereby carrying the suture through the tissue.
(80) The inner wire 6 is then deployed to release the suture 10, retracted, and then the instrument is pulled back out of the tissue 14 as shown in FIGS. 12 and 13. Consequently, a section of suture is left extending through the tissue.
(81) FIGS. 14 to 18 show one possible method of using the current embodiment to retrieve the suture that had previously been passed in order to form a stitch. Once the suture 10 has been passed through the tissue 14 the instrument is used to pierce the tissue 14 at a second location, different from the first location.
(82) FIG. 15 shows the inner wire 6 deployed in order to create spacing between the inner wire 6 and suture slot 7.
(83) With reference to FIG. 16, the device is manipulated in order to position the suture 10 between the inner wire 6 and the needle 5. The inner member 6 is then retracted to secure the suture 10.
(84) FIG. 17 shows the distal working section of the needle 5 pulled back out of the tissue 14 creating a stitch in the tissue.
(85) FIG. 18 shows the inner member in an extended position thereby releasing the suture 10 from the instrument.
(86) Alternative Configurations
(87) The working end 4 of the needle 5 can be formed into a variety of profiles including, but not limited to those illustrated in FIGS. 19 to 21.
(88) FIGS. 19a-19b show needle 5′ having a relatively sharp upwards facing turn. This “Up” version is shown at about 90°. FIG. 19a shows inner wire 6′ in a deployed or extended state. And FIG. 19b shows inner member 6′ in a retracted suture clamping state.
(89) It is to be understood that the shape of the needle may vary. FIGS. 20a-20b, for example, show another needle shape. In particular, the embodiment shown in FIGS. 20a-20b is a 45° “Left” version. Inner member 6″ is shown extended in FIG. 20a, and retracted in FIG. 20b.
(90) FIGS. 21a-21b show a 45° “Right” version. The inner member is shown extended in FIG. 21a, and retracted in FIG. 21b.
(91) The suture slot 7 can be configured into a variety of profiles including, but not limited to those illustrated in FIGS. 22a to 22d.
(92) FIG. 22a shows a suture slot 7 in the body of a needle 5. The slot 7 comprises a plurality of sections or regions. In particular, the suture slot 7 shown in FIG. 22a includes a wire relief area 15 (also shown, for example, in FIG. 34a and indicated by reference numeral 15′) and a suture holding area 16. Suture holding area 16 comprises a proximal ramp 16a, a base 16b, and a distal surface 16c. Proximal ramp 16a is shown having an angle (α) with needle axis (A1). Angle (α) is shown having an angle of about 135 degrees, however, the angle (α) may vary. Preferably, angle (α) is equal to or greater than 90 degrees, and more preferably ranges from 90-135 degrees. Proximal ramp may be vertical.
(93) FIG. 22b shows another suture slot 7′ with a rectangular profile and flat bottom or base 17.
(94) FIG. 22c shows a suture slot 7″ with a distal ramp 18 and without a proximal slot or wire relief region. Distal ramp 18 is shown having an angle (β) with needle axis (A1). Angle (β) is shown having an angle of about 30 degrees, however, the angle (β) may vary. Preferably, angle (β) is less than 90 degrees, and more preferably from 20-65 degrees.
(95) Additionally, though not shown in FIGS. 22a-22c, slot 7 may include both distal and proximal ramps.
(96) Additionally, although a preferred embodiment of the present invention includes a laterally disposed slot comprising a recess, the presence of such a slot is not essential. FIG. 22d, for example, shows an a needle 5 comprising an inner member 6 extending from an opening 19. A suture (not shown) may be clamped or pinned between the inner wire member 6 and the bevel opening 19. Bevel opening 19 does not include a suture holding region or recess in its side walls as shown in other embodiments described herein.
(97) The distal end of the inner member can be configured into a variety of profiles including, but not limited to those illustrated in FIGS. 23a-23c. FIG. 23a shows the inner member as a single wire having a single tooth 20 proximal to the tip of the inner wire. FIG. 23b shows the inner wire with multiple teeth 21 proximal to the tip of the wire. The teeth pattern can be added to improve hold strength on the suture. Other options to improve grip on the suture include, but are not limited to surface treatments of the wire that may add or remove material to roughen the surface of the wire. The height of the teeth may range from 0.1-0.5 mm depending on the size of the inner member.
(98) FIG. 23c shows another possible configuration for the working end of the inner wire in which the wire has two or more bends at the working end. In this instance the wire is configured with a first bend 11 and a second bend 22. First bend is shown being proximal to second bend 22. Preferably, but not necessarily, the first bend is proximal to the tip of the inner wire 6 by a first distance ranging from 2-7 mm. Preferably, but not necessarily, the second bend is proximal to the tip of the inner wire 6 by a second distance ranging from 0.5-3 mm.
(99) First and second bends are shown forming angles θ.sub.1 and θ.sub.2 with the needle axis A1, respectively. θ.sub.2 is less than θ.sub.1. θ.sub.1 preferably ranges from 30-90 degrees. θ.sub.2 preferably ranges from 0-45 degrees.
(100) This configuration of the instrument can be used to produce a gap, space or clearance 23 between the inner wire, suture, and needle to allow the suture to slide while still being trapped in the working end for suture manipulation as shown in FIGS. 24a-24b.
(101) In embodiments, the inner member is sufficiently flexible such that further retraction of the needle further clamps the suture within the slot such that the suture may not slide. The instrument in such embodiments comprises an extended configuration, a suture lock or clamping configuration, and an intermediate suture sliding configuration as shown in FIGS. 24a-24b.
(102) With reference to FIGS. 27 to 28, a working distal section of an inner member is shown including three bends, 27a, 27b, and 27c. The 3.sup.rd bend 27c being positioned near or at the distal tip. Wire member also includes a straight portion 28.
(103) The implementation of multiple bends may be used to facilitate suture sliding. For example, while in the retracted state shown in FIGS. 27d and 28c, the working end of the inner wire and the needle slot could constrain the suture 10 while providing a clearance 29 and 30, respectively, necessary to allow the suture 10 to slide.
(104) Further retracting the inner wire would force the wire to close further thereby pinning the suture. Consequently, in accordance with certain embodiments of the invention, a suture instrument is operable in a plurality of configurations including 1) a deployed or extended configuration in which the inner member extends from the needle creating a space between the inner member and needle, 2) an intermediate or suture sliding position in which the inner member is retracted to a degree such that the suture is slidably held across the needle slot, and 3) a pinned or suture clamped configuration in which the inner member is more fully retracted such that the suture is compressed into the slot and in a tortuous manner to firmly grasp the suture and prevent the suture from sliding. Amongst other things, adding multiple bends to the inner member serves to facilitate in deployment or retraction when implemented with various needle shapes.
(105) Manufacture
(106) The needle can be constructed from a variety of materials or combinations of materials, including but not limited to metals such as stainless steel and titanium, plastics such as polycarbonate and PEEK, or shape memory or super elastic Nitinol.
(107) Similarly, the inner wire can be constructed from a variety of materials or combinations of materials, including but not limited to metals such as stainless steel and titanium or plastics such as polycarbonate and PEEK. The preferred embodiment is shape memory or superelastic Nitinol.
(108) The working end of the needle and inner member preferable has circular cross-sections, though other cross-sectional shapes might also be employed. Other shapes include but are not limited to square, rectangular and ovalized cross-sections.
(109) The cross-sectional area of the inner member may be constant or vary along its length. For example, the inner member can be round at the proximal end and flat at the distal end. The inner member may start off at one diameter and taper down to a lower diameter. FIG. 25, for example, shows an embodiment of the invention comprising an inner member 24 having a proximal section or first diameter section 24a, a second or reduced diameter section 24b, and a third most distal section having an enlarged diameter 24c. In embodiments, the diameter of the inner member ranges from 0.75-2 mm. In embodiments, the ratio of the diameter of section 24a to section 24b ranges from 25-75%.
(110) The inner member can be a single wire or filament. Additionally, the inner member may comprise a wire bundle including two or more wires as shown in FIG. 26. For example, two wires 25 and 26 may be used to perform the same function as a single larger wire member. Implementing multiple wires would allow the wires to translate more easily through the needle while maintaining the rigidity necessary to retain suture. The wires can be attached or detached at the ends or along the length of the wire by adhesives, bonds, fusing, and other attachment techniques known to those of skill in the art.
(111) As described herein the working end of the needle may have a wide variety of shapes and configurations. FIGS. 29a-b show a needle body distal section 31 comprising a single slit 32 which would allow the inner wire to deploy from the needle. Single slit 32 preferably, but not necessarily, is wide enough to allow suture to engage with the inner wire and needle in a similar manner to that illustrated in FIGS. 6 and 7. Single slit 32 differs from some of the needle configurations described herein in that a suture holding region or recess in the needle walls is absent in the single slit (e.g., single slit lacks the suture holding region 16 of FIG. 22a).
(112) FIGS. 30a-30b show a working end of the needle body 34 comprising a single cutoff 33a with a shoulder 33b. This configuration would allow relief for the inner wire while still providing a constraining path for the suture (see, e.g., FIGS. 6 to 7). Additionally, as shown in FIG. 30c, the cutoff may have serrations 35, a roughened surface via for example a surface treatment, or another grip feature in order to provide added suture retention force.
(113) FIGS. 31a-31c illustrate additional possible configurations for the suture slot at the working end of the needle in which a hook or undercut may be used to facilitate suture retention and or manipulation. FIG. 31a shows a suture slot with a proximal hook/undercut 36. The undercut 36 is formed in the wall of the needle body. Inner member is shown having two bends in this embodiment.
(114) FIG. 31b shows a suture slot comprising a distal hook/undercut 37. Inner member is shown having three bends in this embodiment.
(115) In embodiments, the needle may comprise a hollow or solid tip or end. FIG. 31c shows a suture slot with a distal hook/undercut 37 and a solid needle tip 38. The solid tip may facilitate tissue penetration. The solid tip may also work in conjunction with the inner wire to form clearance for suture sliding with or without multiple bends at the working end of the inner wire. The solid tip can be formed by a variety of methods including but not limited to filling in the needle tip with a solder or epoxy. A plastic rod can be bonded or mechanically attached within the inner diameter of the needle to form the solid tip. A metal rod can also be welded, bonded or mechanically attached within the inner diameter of the needle to form the solid tip.
(116) The inner member shown in FIG. 31c includes two bends. However, as described herein the inner member may have one or more bends depending on the desirability of suture clamping force, and whether an intermediate suture sliding position is desired.
(117) FIGS. 32a-32c illustrate another embodiment of a distal section of a needle 100 and inner member 110 in a retracted configuration. The distal section of the needle comprises a needle body 132 having a gently curved crescent shaped profile, a sharpened distal tip 120, and a lumen 134 extending therethrough.
(118) As described herein the inner member 110 is operable to move from a retracted position to a deployed or extended position from the needle body. A suture not shown may be clamped or grasped between the inner member and needle when the inner member is in the retracted position.
(119) The embodiment shown in FIGS. 32a-32c includes a suture slot 130. The suture slot 130 comprises a plurality of sections including a wire relief section 142, and a suture holding section 144. The inner member 110 is shown in a retracted position, and has an inner member tip portion disposed within slot 130.
(120) With reference to FIG. 32b, suture holding section 144 is shown as a recess in the side walls or body of the needle 100. Suture holding section 144 comprises a proximal shoulder or surface 146, a base or trough section 148, and a distal ramp 150. The dimensions and angles and of the features are preferably in the range as described herein such as but not limited to the embodiments shown in FIG. 22.
(121) As described herein, the suture holding region 144 serves to clamp the suture when the inner member is retracted. The degree of clamping may be bolstered by modifying the design including for example, material selection, increasing the width of the trough 148, increasing the number of bend angles present in the inner member, or increasing the degree of the bend angles of the inner member.
(122) Additionally, suture release form the instrument may be facilitated by, amongst other things, decreasing the distal ramp angle so as to allow the suture to slide more freely out of the virtual jaw grip formed between the needle and the inner member. Many features of the described embodiments may be modified to achieve a desired design, result or application, and such modifications are intended to be part of the invention. The invention is intended only to be limited as set forth in the appended claims.
(123) FIGS. 33-36 illustrate various constraining features to further hold the inner member, trapping the suture, when the suture instrument is in the retracted suture-clamping configuration.
(124) FIGS. 33a-33b illustrate a distal needle section 200 including a needle body 202, a tissue penetrating distal tip 204, a lumen 206 extending therethrough, and a suture slot 208. Inner member 212 is shown having a plurality of bends and in a deployed configuration. Inner member extends away from the needle body. As described herein, spacing the inner member away from the needle body as shown in FIGS. 33a-33b serves to create a space within which the suture (not shown) may be inserted or placed.
(125) FIG. 33c shows inner member 212 in a retracted configuration. Distal section of the inner member is substantially disposed within the suture slot 208 and in particular, a distal tip or end 214 of the inner member is rotated or manipulated until it is fit within hole or aperture 216 in the needle body 202.
(126) FIGS. 34a-34c show another needle distal section and inner member in a retracted configuration. The embodiment shown in FIGS. 34a-34c differs from that shown in FIGS. 33a-33c in that the embodiment shown in FIGS. 34a-34c includes a ferrel type constraining feature. In particular, ferrel 224 comprises a cylindrical body having a cavity to receive the tip of the inner member 222. Ferrel 224 may be bonded or otherwise affixed within the slot 226 of the needle section. The ferrule 224 is attached to the wire 222 and is pulled into the tube such that the ferrule restricts the wire from being pulled perpendicular to the needle axis by having a larger diameter than the width of the narrowed portion (or neck 225) of the suture slot 226.
(127) FIGS. 35a-35d show another needle distal section 230 and inner member 232 in a retracted configuration. The embodiment shown in FIGS. 35a-35d differs from that shown above in that the embodiment shown in FIGS. 35a-35d includes a cleat type constraining feature 234. Cleat 234 includes an abutment surface or lip which snugly holds the distal end of the inner member when the inner member is retracted.
(128) FIGS. 36a-36c show another needle distal section 240 and inner member 242 in a retracted configuration. The embodiment shown in FIGS. 36a-36c differs from that shown above in that the embodiment shown in FIGS. 36a-36c includes a bulbous constraining feature 244. In particular, the inner member 242 terminates in a rounded spherical shape 244. The bulb snugly fits within the needle slot (e.g., by interference fit). Bulb 244 may be bonded or otherwise affixed to inner member, or may be formed as part of the inner member.
(129) The above described constraining features serve to further or redundantly secure inner member within the slot to prevent deployment of the inner member, and to prevent inadvertent release of the suture.
(130) As described herein, embodiments of the invention facilitate suture release from the instrument after the suture has been clamped.
(131) With reference to FIGS. 37-38, perspective and cross sectional views respectively of the working end of a suture manipulating instrument 310 in a suture clamping configuration is shown. Inner member 312 (e.g., a preformed wire) holds suture 314 in place by pinching it against needle 316. To release the suture, inner member 312 is moved distally. This unclamps the pinching force on the suture 314. Sometimes, however, the suture can remain in the suture recess or slot 318 of the needle 316, making it difficult to release the suture when performing an arthroscopic procedure.
(132) In embodiments, the suture is released from the inner member despite the bias to remain in slot 318. With reference to FIGS. 39-40, inner member 312 is shown being retracted in the proximal direction and, as the inner member 312 is retracted, it rides over (and clears) the suture 314. Consequently, the suture remains within suture recess 318 and is not dragged into inner lumen 313. In a sense, the suture 314 is stripped from the inner member 312.
(133) Once inner member is retracted and not pinching suture, the suture is free to move. However, it may still be positioned in the suture recess or slot 318. In embodiments, and as shown in FIG. 41, inner member 312 is pushed distally, thus ejecting the suture 314 out of the suture recess 318.
(134) FIGS. 42a-42b show additional features serving to prevent the suture 314 from being drawn or sucked into the inner lumen tube 320. In certain embodiments it is desirable to prevent the suture from being sucked into the lumen 320 because doing so would restrict the ability of the operator to push the suture 314 (e.g., to eject the suture) from the instrument. In the embodiments shown in FIGS. 42a-42b, the size of the opening 326 leading to inner lumen 320 is restricted. In FIG. 42a, for example, a detent 322 is placed in the floor of the needle 316. In FIG. 42b, tabs 324 are deformed near the proximal portion of the opening 326. The features shown FIGS. 42a-42b serve to strip the suture 314 off inner member 312 as the inner member is pulled proximally into the inner lumen 320. The suture may then be more easily released or ejected from the instrument.
(135) It is to be understood that the features described above to assist in stripping the suture from the inner member may vary widely. For example, a stripping means such as a tab or detent may be disposed at one or more locations along the needle lumen. Additionally, the feature may extend up to a full diameter of the inner lumen. Additionally, the feature may extend about the entire circumference. Or, the feature may be limited to an arcuate segment.
(136) A protrusion to strip the suture may be positioned within the lumen, or at the entrance of the lumen. The suture may thus be stripped from the inner member inside the lumen or outside the lumen.
(137) FIGS. 43-44 are perspective and cross sectional views respectively of the working end of another needle distal section 410 and inner member 412 shown in an extended configuration. More specifically, FIGS. 43-44 show a perspective and cross-sectional view of an inner member 412 that has been deployed more distally than the embodiments shown in FIGS. 37-42. As described herein, extending the inner member pushes the suture 416 out of the suture recess 414. FIG. 45 shows the suture 416 having been pushed out of the suture slot 414 by the distally deployed inner member 412.
(138) FIGS. 46a-46b show embodiments of an instrument including features serving to facilitate the suture eject (or push-out) method described herein. FIG. 46a, for example, shows inner member 412 having a notch 418. Notch 418 aids in ‘grabbing’ the suture as the inner member 412 is being deployed distally. FIG. 46b shows another feature to facilitate ejecting or pushing out the suture as the inner member is pushed distally. In particular, FIG. 46b shows a sleeve 420 coaxially surrounding the inner member 412 thus creating a shoulder to catch the suture (not shown).
(139) The features described above to assist in ejecting or pushing the suture may vary widely. For example, a pushing suture means may extend a full or partial diameter, and be located at one or more places along the wire.
(140) Retracting Suture into Needle Lumen
(141) FIG. 47 is a perspective view of the working end of another needle distal section 510 and inner member 514 in an extended configuration. The inner member 514 has been extended, deploying suture 512. The needle 510 and recess 518 may be the same shape as described herein except that the inner member 514 (shown as a wire) has a grasping ring 516 located near the distal end of the inner member.
(142) FIGS. 48-49 are perspective and cross sectional views respectively of the working end of the needle 510 shown in a suture grasping configuration. The inner member 514 is shown pinching the suture 512 to hold it in the suture slot 518. As will be described in more detail herein the suture may be subsequently drawn into the inner lumen 520 of needle 510 by further retracting the inner member 514 to a second or more proximal location.
(143) FIG. 50 is a cross sectional view of the needle distal section shown in FIGS. 48-49, shown with the inner member in a further retracted configuration. In particular, inner member 514 has been pulled proximally into the inner lumen 520, dragging the suture 512 into the inner lumen with the aid of the grasping ring 516.
(144) FIG. 51a is a cross sectional view of the working end of the needle distal section, suture, and inner member 514 wherein the inner member is shown being moved distally within the lumen 520, and urging the suture in the direction (A).
(145) FIG. 51b shows an enlarged view of a gripping feature 516 acting on the suture 512. In embodiments, the gripping features 516 partially press, compress, cut into, capture and/or pierce the suture. In embodiments, the gripping features may have serrations or corners that the suture fibers stick to, hang up on, or become entangled. These gripping features reliably serve to maneuver the suture 512 proximally and distally, and to eject the suture from the inner lumen 520. Such gripping features may vary widely and include serrations, corners, notches, rings or other structures and geometries.
(146) FIG. 51c is a perspective view of the working end of the needle distal section, suture, and inner member shown in FIG. 50, in an extended or deployed configuration. In particular, FIG. 51c shows the suture 522 having been pushed out of the inner lumen 520 by grasping feature (and or pushing means) 516 located on inner member 514.
(147) FIG. 51c also shows suture having a relatively large suture loop 522. The suture loop 522 is approximately equal to the length of suture (D.sub.L) pulled into the inner lumen 520. This relatively large loop 522 is advantageous in arthroscopic surgery because it may be more easily grabbed by a surgeon than a smaller loop.
(148) FIG. 52 shows suture passer 510 penetrating through tissue 524 and carrying the suture 512. Once through the tissue, the inner member 514 (with the aid of the grasping ring 516) pushes the suture out of the inner lumen. A relatively large loop 522 is thereby created that can be easily retrieved by the surgeon.
(149) The size of the loop created by the instrument may be selectively set during a procedure, or predetermined. For example, in embodiments, the handle may include a lever as described herein and have a lever path or slot in the handle for the lever to move. The lever may be coupled to the inner member such that the length of travel through the lumen during the retraction step coincides with the length of travel of the lever. The handle and lever may be marked to indicate the loop-size increments. Additionally, the handle, lever and inner member may include hard stops and a limited range of motion to prevent undesirable-sized loops. For example a lever path may be shaped to limit the length that the lever may travel (e.g. a 0.3 to 0.5 inch and in some embodiments about 0.4 inch long rectangular slot).
(150) An exemplary range for the length of the large loops (L.sub.L) described herein are 0.3 to 0.5 inches, and more preferably between about 0.4 inches.
(151) The shape of the grasping or pushing feature may vary widely. FIG. 53, for example, shows a trough or detent 534 for catching and manipulating the suture in the proximal and distal direction. The protruding surfaces may be formed by two rings affixed to the shaft and spaced apart a small distance to form the trough.
(152) FIG. 54 shows a cut or notch 544. These features interact with, namely, grab, draw, and push the suture. Many variations of the grasping feature and means are intended to be included as part of the invention unless specifically excluded by the appended claims. For example, rings may extend partially around the circumference of the inner member. Protrusions, detents, cuts (e.g. a spiral cut), may be incorporated or formed into the distal end of the inner member. Additionally, the feature may comprise frictional means such as a surface roughening, asperity, burr, or frictional material which presents greater frictional force on the suture than on the wall of the inner lumen. Hence, when the inner member is moved, the suture follows.
(153) FIG. 55 shows another structure adapted to grasp and draw the suture into the needle. In FIG. 55, the inner member comprises a dogleg distal section. The dogleg tip serves to assist in drawing the suture into the lumen during the retraction step of the procedure described above.
(154) FIGS. 56a-56b are side and front views respectively of the inner member shown in FIG. 55. The inner member 552 is shown comprising an elongate section 554, terminating at a first bend 556. A non limiting exemplary range for the length of the elongate section 554 is between 8 and 9 inches. A non limiting exemplary range for the first angle of is between 70 and 85 degrees, and more preferably between 75 and 80 degrees. The dogleg is characterized by a lateral extending leg portion 558 and a second bend 560. An exemplary range for the length of the leg portion 558 is between 0.2 and 0.3 inches. The second bend angle may range from 80-90 degrees, and preferably from 85-89 degrees. The length of the tip segment 562 may range from 0.5 to 0.7 inches. Additionally, the diameter of the inner member may range from 0.015 to 0.025 inches.
(155) FIG. 57 is a side view of another embodiment showing inner member 570 in an extended configuration. The inner member 570 comprises a crochet shaped distal section 572. The crochet tip serves to assist in drawing the suture into the lumen during the retraction step (as well as pushing the suture out of the lumen) during a procedure as described above.
(156) FIGS. 58a-58b are side and front views respectively of the inner member 570 shown in FIG. 57. An elongate shaft extends to a first bend 571. A lateral segment extends from the first bend to second bend 573. A third bend 574 forms the crochet-shaped end portion. Many of the dimensions may be similar to that described above in connection with FIGS. 56a-56b except that the crochet tip extends and forms a smooth rounded semi circle. The semi circle shape is advantageous over a full circle hook because a full circle hook can have a tendency to fail to release the suture, and fail to smoothly fit within an arthroscopic needle.
(157) A non-limiting exemplary inner radius 574 and outer radius 576 for the crochet tip is approximately 0.015 and 0.040 inches respectively. A non-limiting exemplary height 578 ranges from 0.2 to 0.3 inches.
(158) FIG. 59a is a side view of the working end of another suture passing instrument showing inner member 580 in an extended configuration. The inner member comprises a box shaped distal section 582. The box shaped tip serves to assist drawing the suture into the lumen during the retraction step (as well as pushing the suture out of the lumen).
(159) FIG. 59b is a side view of the inner member shown in FIG. 59a. An elongate shaft extends to a first bend (A). A lateral segment extends from the first bend to second bend (B). Second bend extends to a third bend (C). A base region forming the bottom of the box extends to fourth bend (D).
(160) Many of the dimensions (e.g., shaft outer diameter [OD]) shown in FIGS. 59a-59b may be similar to that described above in connection with FIGS. 58a-58b except that the box shaped tip 582 comprises a pair of dog-legs or right angles to make a box-like shape instead of a rounded semi-circle or crochet end. A non-limiting exemplary depth 584 of box is approximately 0.04 to 0.06 inches respectively. A non-limiting exemplary height 586 ranges from 0.2 to 0.3 inches.
(161) FIGS. 60a-60b are side and front views respectively of the working end of another embodiment showing inner member 594 shown in a deployed or extended configuration. The inner member 594 comprises an open trapezoidal-shaped (or parallelogram-shaped) suture grasping cavity 596. With reference to FIGS. 60c-60d, the grasping region may be defined by a pair of side walls separated by a width (W) and having a depth (D). The side walls are shown at different angles from one another. However, the side walls or portions of the side walls may be parallel or close to parallel with one another. Additionally, as shown, the shape or curvature of each of the side walls may vary and may be different from one another. For example, as shown, the distal most side wall has a greater curvature than the more proximal side wall. Similar to the crochet or box shaped grasping feature discussed above, the grasping space 596 serves to move the suture within the needle as will be described in more detail herein.
(162) The inner member 594 shown in FIGS. 60a-60d may be made from a flat sheet. The inner member 594 is shown having a thickness (t.sub.1) in the range from 0.01 to 0.03 inches, and more preferably about 0.02 inches. Its sides may be flat. The height (H) may range from 0.25 to 0.35 inches. Such an inner member may be machined to size, or otherwise formed by removing or cutting away material from a flat sheet. Exemplary materials include stainless steel, spring steel or Nitinol. No shape setting is required. The shapes may be cut using well know conventional machining techniques (such as EDM) or otherwise formed. Additionally, in certain embodiments, thin sheets may be stacked together and machined to shape as a batch.
(163) The flat inner member 594 has varying stiffness along its length. The stiffness may be adjusted by varying the cross section, effective diameter or thickness of the member along its length. Preferably, in certain embodiments, the tip section 596 comprises a stiffness sufficient to grasp the suture whereas the elongate straight base sections are relatively more flexible to allow for these sections to elastically deform while advanced through the curves of the needle lumen in the distal section of the needle.
(164) In certain embodiments the inner member's varying cross sectional size allows for only elastic deformation in certain portions of the inner member (e.g., proximal sections) while allowing other portions of the inner member (e.g., the distal tip) to be relatively stiff. In certain embodiments, the proximal section is narrower or thinner than the distal tip section. The distal tip section has a larger cross section than the proximal section in embodiments. Even when the distal section is placed under stress, it will not deform and can hold onto the suture.
(165) In certain embodiments the inner member comprises a “flat wire” design, and has a larger distal cross section than the proximal section. However, the invention is not so limited and other cross sectional shapes may be employed.
(166) Without being bound to theory, the inventors have found that the flat cross section can enable about two times or more the torsional stability of the inner member within the needle lumen than a round cross section while retaining substantially the same elastic deformation and flexibility of the inner member. By torsional stability, it is meant the ability to maneuver between obstacles such as suture and tissue without plastically deforming, buckling, or twisting. Additionally, the inventors have found that being able to vary the cross section of the inner member has enabled a three to four times greater functionality in suture retention.
(167) In contemplated embodiments the cross section along the inner member varies. The cross section is relatively small along the proximal section. The smaller cross section allows for elastic deformation of the inner member as it is advanced through the needle lumen. The cross section of the inner member is larger towards the distal tip. The larger cross section at the distal tip provides enhanced stiffness to grab and pull the suture. In contrast, an inner wire having a uniform-sized cross section may be robust enough to sufficiently grasp a suture but is undesirably susceptible to plastic deformation due, to the influence of curves in the needle lumen. For example, if the entire cross section of the inner wire is enlarged such that the distal tip section is stiff and can adequately grab the suture limbs, the inner member is less likely to elastically deform and more likely to plastically deform due to the influence of the needle lumen. This effect is magnified in more tortuous versions of the needle tip such as the instruments shown in FIGS. 19 and 20
(168) If the entire cross section of the inner member is reduced such that the inner wire is highly flexible and can elastically deform as it advanced through the needle lumen, the distal tip section will lack the stiffness to grab the sutures and may ultimately plastically deform such that consistent suture grasping is difficult. For these reasons, a varying cross section is a preferred embodiment. However, the invention is only intended to be limited as recited in the appended claims, and in embodiments, the inner member wire has a cross section that is uniform along its length.
(169) FIG. 60c also shows an atruamatic nose tip 596. Such a tip may be machined or otherwise formed on the tip of the hook. A pointed nose tip enables easier maneuvering of the instrument. A smooth pointed nose tip may serve to separate sutures extending from an anchor such that at least one of many suture tails may be selected and captured. A suture bundle may be more conveniently approached and separated with a nose tip as shown in FIG. 60c.
(170) FIG. 60e shows a side view of another flat inner member 602 comprising an elongate box-shaped hook 604. In particular, the length of the base portion W.sub.2 ranges from 0.02 to 0.12 inches. Additionally, the proximal section of the wire has thickness (t.sub.3) of 0.015 to 0.045 inches (and in one embodiment t.sub.3 is about 0.02 inches). Thickness (t.sub.3) tapers to a smaller dimension towards the distal portion and is limited by the ID of the needle. In embodiments, the thickness (t.sub.3) is such that the inner member fits snuggly in the ID of the needle.
(171) FIG. 60f shows a side view of another flat inner member 612 comprising an elongate dog leg-shaped hook 614. The length of the hook portion H ranges from 0.02 to 0.12 inches, and preferably is about 0.04-0.05 inches. Radius 1 (R.sub.1) is about 0.08 inches (consequently forming an angle (theta) ranging from about 45-90 degrees, and more preferably between about 45-60 degrees. Radius 2 (R.sub.2) is about 0.01-0.02 inches. Additionally, the proximal section of the wire has thickness (t.sub.3) of 0.005 to 0.045 inches (and in one embodiment t.sub.3 is about 0.02 inches). Thickness (t.sub.3) tapers to a smaller dimension (t.sub.4) towards the distal portion and is limited by the ID of the needle. In certain embodiments, the thickness (t.sub.3) is such that the inner member fits snuggly in the ID of the needle. In the structure shown in FIG. 60f, (t.sub.4) is about 0.05-0.2 inches. Thickness (t.sub.5) is about the same as (t.sub.4). Thickness (t.sub.6) is shown being larger than (t.sub.5) and in embodiments, ranges from 0.005-0.2 inches. As mentioned herein, the dimensions (e.g., angles, lengths, and thickness') of the embodiments may vary and be interchangeable with the dimensions of another embodiment except where such dimensions or features are mutually exclusive.
(172) FIGS. 61a-61c are cross sectional views of the needle distal section 592 and inner wire member 594 shown in FIGS. 60a-60b, cooperating together to grab and draw a suture 600 into the needle lumen 598. The inner member 594 has been extended, creating a suture capture zone. The instrument is manipulated such that the suture 600 is positioned between the needle slot 593 and the inner member 594.
(173) FIG. 61b is a cross sectional view of the needle distal section 592 shown in a suture grasping configuration. The inner member 594 is shown pinching the suture 600 to hold it in the suture slot 593.
(174) FIG. 61c is a cross sectional view of the needle distal section 592 shown in a further retracted configuration. In particular, inner member 594 has been pulled proximally into the inner lumen 598, dragging the suture 600 into the inner lumen with the aid of the grasping feature 596.
(175) A suture loop may be formed which is approximately equal to the length of suture pulled into the inner lumen 598. This relatively large loop is advantageous in arthroscopic surgery because it may be more easily grabbed by a surgeon than a smaller loop.
(176) In embodiments of the invention, a method comprises the following steps: a) grasping the suture, b) drawing the suture into the lumen, and c) ejecting the suture from the instrument. Without being bound to theory, suture grasping and drawing forces may be compared to a suture pull out force. By pull out force, it is meant a maximum force applied to the suture until the suture is pulled out from the target material or instrument.
(177) The drawing/grasping forces of various suture instruments were measured. In particular, various instruments as described herein were fabricated and manipulated to grab one suture tail, two suture tails and the pull out force was measured. Additionally, as the wire inner member was advanced through the needle lumen, a qualitative evaluation of the suture ejection was recorded (“1” being worst, not able to eject the suture, and “3” being best, full suture ejection and release).
(178) Results are shown in the below table.
(179) TABLE-US-00001 TABLE 1 One tail Two tail Suture Pull out Pull out Ejection (grasping (grasping (1-3, 3 force, force, being Description pounds) pounds) best) Comments Nitinol Wire, 2.8 2.8 3 Relatively low One Ring pullout force. Highly navigable through needle lumen without plastic deformation. Dogleg, Wire 4.5 6 2 Relatively medium Nitinol pullout force and suture ejection. Crochet, Wire 4 5 3 Highly navigable Nitinol through needle lumen without plastic deformation. Medium pullout strength. Trapezoid, Flat 12 22 3 Highly navigable Nitinol through needle lumen without plastic deformation, and excellent pull out force. Full circle 0 7 1 Spools single suture. “Sheppard” Not able to eject hook, variable suture from hook. diameter
(180) Except for the full circle (or Sheppard's hook) design, the structures described above in the table operated to effectively navigate through an arthroscopic needle without any plastic deformation, grasp and pull the suture into the lumen with the forces listed above, and subsequently eject the suture from the needle to varying degrees of success.
(181) The flat Nitinol wire with a trapezoid-shaped distal tip section showed a marked increase in suture pull out strength without any sacrifice in the ability to eject a suture, or suffer from plastic deformation. This data supports a conclusion that embodiments described herein (a) provide desirable suture pull out strength, (b) are easily navigable through the needle lumen without plastically deforming, and (c) predictably eject or release the suture from the instrument.
(182) In embodiments, the described inner wires advantageously display a combination of stiffness at one region for firmly grasping the suture tail, but also a flexibility at other regions so as to avoid plastic deformation.
(183) Without being bound to theory, embodiments of the invention described herein provide excellent suture pull out strength and suture ejection because of a combination of unique characteristics including but not limited to the cross sectional shape of the inner wire, the variation in cross section along its length, the number of bends along its length, the angle of the bends, and the shape of the suture capture zone.
(184) Other modifications and variations can be made to the disclosed embodiments without departing from the subject invention. For example, FIG. 62 shows a side view of another needle distal section 710 and inner wire member combined in an extended configuration. The needle distal section 712 differs from the embodiment shown in FIGS. 61a-61c in that the slot profile is different. In particular, the needle wall shown in FIG. 62 includes a discrete cut out or recess whereas the slot profile shown in FIGS. 61a-61c has a shoulder or step design. Indeed, there are numerous potential shapes and features for the components of the invention, and numerous combinations of inner members and needle shapes, all of which are intended to be part of the invention except where excluded by the appended claims.
(185) Additionally, other methods for suture manipulation and tissue repair will be apparent to the skilled artisan. Moreover, the instruments and methods described herein may be utilized in other regions of the body (e.g., knee, hip, etc.) and for other tissue treatment procedures. Thus, while the exemplary embodiments have been described in detail, by way of example and for clarity of understanding, a variety of changes, adaptations, and modifications will be obvious to those of skill in the art. Therefore, the scope of the present invention is limited solely by the appended claims.
