WO2007059178A2

WO2007059178A2 - Multiple offset eyelet suture anchor

Info

Publication number: WO2007059178A2
Application number: PCT/US2006/044273
Authority: WO
Inventors: Peter K. Sorensen; Paul V. Fenton, Jr.
Original assignee: Axya Medical, Inc.
Priority date: 2005-11-14
Filing date: 2006-11-14
Publication date: 2007-05-24
Also published as: JP2009515653A; EP1948034A2; AU2006315488A1; US20070112352A1; WO2007059178A3; US8029536B2; EP1948034A4

Abstract

A suture anchor for securing soft tissue to bone may include a threaded body, a head extending along a longitudinal axis, and a plurality of eyelets that extend though the anchor head and that are each configured to receive a suture. The eyelets are offset from one another along an axis that is transverse to the longitudinal axis of the suture anchor. Each eyelet may have a desired shape and cross section. Surgical kits including one or more suture anchors and one or more surgical tools are also described.

Description

MULTIPLE OFFSET EYELET SUTURE ANCHOR

BACKGROUND

[0001] When biological soft tissue, such as a ligament, tendon, or cartilage, becomes separated from related bone, surgical procedures are commonly employed for reattachment of the soft tissue. Various devices, including sutures, screws, staples, wedges, and plugs have been used to secure soft tissue to bone. Additionally, structures known as suture anchors have been developed for this purpose.

[0002] Some suture anchors are designed to be inserted into a pre-drilled hole, while other suture anchors are threaded and self-tapping. Some suture anchors include an eyelet for receiving a suture, while other anchors are cylindrical and adapted for holding a knotted piece of suture, while still other anchors include a strand of suture insert molded in the anchor. Certain suture anchors having one or more generally parabolic eyelets are described in U.S. Patent No. 6,610,080 to Morgan, the contents of which are incorporated herein by reference. The Morgan patent describes suture anchors arrangements having multiple eyelets for securing two or more sutures to a desired location on a bone, but these arrangements may be susceptible to breakage or structural failure around the eyelets under certain conditions.

[0003] What is needed, therefore, is an improved suture anchor capable of securing multiple sutures for reattachment of soft tissue to bone. What are also needed are kits including such suture anchors and arthroscopic apparatus for surgery using such anchors.

SUMMARY

[0004] The needs described above are addressed by the present disclosure, which is directed to multiple offset eyelet suture anchors and related surgical kits. The suture anchors include multiple eyelets that are offset in a direction transverse to a longitudinal axis of the anchor for holding multiple sutures, such as in reattachment surgery securing soft tissue to bone. [0005] One arrangement of a suture anchor according the present disclosure may include an anchor head and a threaded body. The head may include two or more eyelets each defining a void region extending between opposite lateral surfaces, each eyelet being adapted to receive a suture. Within the anchor head, each eyelet is offset, or spaced apart, from the other a distance along the longitudinal axis A and also a distance in a direction transverse to the longitudinal axis A. Such arrangements may provide increased strength and resistance to failure, such as shearing of material around the eyelets.

[0006] Each eyelet may be shaped as desired. In some arrangements, for example, an eyelet may have a parabolic and/or elliptical cross section and include two outer void regions and a central void region extending between the outer void regions along a suture-direction axis extending transverse to the longitudinal axis of the body. For such parabolic cross section eyelets, an outer void region may extend from one of the lateral surfaces of the anchor head and have a central axis forming an acute angle with the longitudinal axis of the body. For further example, each eyelet may have a surface shaped as a segment of a desired conic surface extending about the central axis of the outer void region and tapering inward towards the longitudinal axis of the body. The void region of each eyelet may extend about a central axis having a desired configuration, e.g., a straight line or a curved line. Curved-line configurations may have any suitable shape, e.g., serpentine, sinusoidal, irregular, etc.

[0007] Another arrangement of the present disclosure may include a surgical kit including a suture anchor according to the present disclosure and further including a drill guide. The drill guide may have a handle and a hollow guide shaft rotatably secured to the handle, the guide shaft having a tip and an alignment window adjacent the tip. An adjustment wheel may extend radially from the shaft. Within such kits, the drill guide may include a button that is positioned within the handle and that may be movable to a locked position preventing rotation of the adjustment wheel. [0008] The kit may include at least one length of suture. The suture may be a monofilament or may include multiple filaments. One end of the length of suture may be deformed. The suture may be bio-compatible. The suture of the kit may be bio-absorbable.

[0009] In certain arrangements, a kit may include a tubular drive tool having a handle and a tube extending from the handle to a distal end. A drive socket may be attached to the distal end of the tube and may include inwardly facing surfaces for gripping outwardly facing surfaces of an anchor head of a suture anchor for transferring torque from the drive tool to the suture anchor. The inwardly facing surfaces may include recesses positioned for alignment with the outer void regions of an eyelet of the anchor and sized to receive a suture passing through the eyelet.

[0010] Additional advantages and aspects of suture anchors and surgical kits according to the present disclosure will be readily apparent to those skilled in the art from the following detailed description, wherein arrangements of the present invention are shown and described. The present disclosure, in addition, is capable of other and different arrangements, and its several details are susceptible of modification in various obvious respects, all without departing from the spirit of the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as limitations.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a frontal view of a suture anchor constructed in accordance with the present disclosure;

[0012] FIG. 2 is a side view of the suture anchor of FIG. 1 ;

[0013] FIG. 3 is a sectional view of the anchor head of the suture anchor of FIG. 1 in the direction of cutting plane 3-3;

[0014] FIG. 4 is a sectional view of an anchor head in accordance with an alternate arrangement; [0015] FIG. 5 is a frontal view of a suture anchor in accordance with a further arrangement;

[0016] FIG. 6 is a side view of the suture anchor of FIG. 5;

[0017] FIG. 7 is a frontal view of an anchor head with parabolic eyelets in accordance with another arrangement of the disclosure;

[0018] FIG. 8 is a sectional view of the anchor head of FIG. 8 in the direction of cutting plane 8-8;

[0019] FIG. 9 is a side view of a suture anchor having parabolic eyelets similar to those shown in FIG. 7;

[0020] FIG. 10 is a perspective view of another arrangement of a suture anchor head in accordance with the present disclosure.

[0021] FIGS. 1 IA-B are side and top section views, respectively, of a suture anchor head similar to the one of FIG. 10.

[0022] FIG. 12 is a frontal view of an alternate configuration of a suture anchor head.

[0023] FIG. 13 is a perspective view of a drill guide constructed in accordance with the present disclosure;

[0024] FIG. 14 is a side elevation view of a drive tool suitable for use with suture anchors according to the present disclosure;

[0025] FIG. 15 is a perspective view of the drive tool of FIG. 14;

[0026] FIG. 16 is an enlarged elevation side view of a tip of the drive tool of FIG. 14;

[0027] FIG. 17 is an enlarged elevation end view of the tip of the drive tool of FIG. 14; and

[0028] FIG. 18 is a perspective view of another tip of a drive tool constructed in accordance with the present disclosure shown being used with, for example, the suture anchor of FIG. 6. [0029] In the figures, like reference characters designate identical or corresponding components and reference characters, including axes, angles and units.

DETAILED DESCRIPTION

[0030] Arrangements of the present disclosure are directed to suture anchors having multiple eyelets that are offset along an axis transverse to a longitudinal axis of the anchor. The offset eyelets may provide additional material to withstand forces in particular directions while still providing a suture anchor that can hold two or more sutures to a desired location, such as a particular location on a patient's bone. The offset configurations of the two or more eyelets allows for increased suture-to-anchor strength, e.g., resistance to the suture shearing through the anchor head. A suture anchor as disclosed herein can be used with suitable types of sutures including monofilament sutures, braided sutures, absorbable sutures, and nonabsorbable sutures.

[0031] Referring to FIG. 1, a frontal view is shown of a suture anchor 10 constructed in accordance with an arrangement of the present disclosure. The anchor 10 includes an anchor head 11 and a threaded body 13 extending along a longitudinal axis A. The anchor head 11 also includes at least two eyelets 12 that extend between lateral surfaces 15 of the head 11. Each eyelet 20 has two openings 20 and a central void region 14 for securing a length of suture 200 to bone (not shown). In addition to the lateral surfaces, the anchor head 11 may include a number of sides 21 and a top surface 26 to achieve a desired cross-sectional shape of the anchor head, e.g., one suited for a driving tool shown in FIGS. 13-18.

[0032] Within the anchor head 11, each eyelet 12 is offset, or spaced apart, from the other a distance v along the longitudinal axis A and also a distance ω in a direction transverse to the longitudinal axis A, for example, as indicated by locations of respective eyelet central axes D and E. The void region 14 of each eyelet may be aligned substantially parallel with a suture- direction axis (e.g., axis C shown in FIG. 2) of the anchor 10. Lateral axis B, transverse to longitudinal axis A is shown for reference. While the defining surface of the central void region 14 is preferably cylindrical, it can be any other suitable shape, e.g., concave, variable in cross section, etc. Because of the locations of the eyelets 12 relative to one another within the suture anchor 10, the void regions 14 are separate and discrete.

[0033] As described, the suture anchors 10 include a threaded body 13 for insertion of the anchor 10 into a bone at a desired location. The threaded body 13 may include a suitable number of threads having a desired pitch. In certain arrangements, the threaded body 13 can be self-tapping and can include a self-drilling tip if desired.

[0034] FIG. 2 is a side view of the suture anchor 10 of FIG. 1 showing the relationship of the eyelets 12 within the anchor head and relative to the threaded body 13. The eyelets 12 are shown at unique locations along the longitudinal axis A of the anchor 10, with one eyelet located in closer proximity to the threaded body 13. As shown by respective central axes D and E, the void region 14 of each eyelet 12 extends along suture-direction axis C (which is substantially orthogonal to lateral axis B shown in FIG. 1) and between the lateral surfaces 15 of the anchor head 11.

[0035] FIG. 3 is a sectional view of the anchor head 11 of FIG. 1 in the direction of cutting plane 3-3. The void regions 14 are aligned along respective central axes D and E, extending between lateral surfaces 15 of the anchor head 11. The lateral surfaces 15 may be configured to form recesses 17, which may facilitate protection of sutures and/or application of the anchor 10 by a surgical tool, e.g., arthroscopic tools 70 and 90 shown in FIGS. 13-18. Recesses 17 may be formed oμ opposing sides of the anchor head 11 between pairs of ribs 19 extending along the C axis.

[0036] FIG. 4 is a sectional view of an anchor head 11 in accordance with an alternate arrangement of which the cross sectional shape of the head 11 is rectangular, without recesses being present. For the arrangement shown, void regions 14 of eyelets 12 extend along respective central axes D and E similar to the arrangement of FIG. 3 but lateral surfaces 15 are located at a greater relative distance along the central axes D, E. [0037] FIG. 5 is a frontal view of a suture anchor 10 in accordance with a further arrangement in which eyelets 12 are counter-bored. The arrangement shown is similar to that of FIG. 1 in that each eyelet 12 is offset, or spaced apart, from the other a distance along the longitudinal axis A and also a distance in a direction transverse to the longitudinal axis A. The eyelets 12 may have a counter-bored configuration, indicated respectively by outer and inner diameters 12a and 12b. Such counter bores for eyelets 12 may facilitate reduced damage to a suture and/or reduce manufacturing costs of the suture anchor 10.

[0038] FIG. 6 is a side view of the suture anchor 10 of FIG. 5. As shown, eyelets 12 have void regions 14 extending along respective central axes D and E between lateral surfaces 15 of the anchor head 11. Each eyelet 12 has a counter bored opening onto the lateral surfaces 15 of the anchor head 11, as indicated by outer diameter 12a and inner diameter 12b along respective central axes D and E.

[0039] Referring to FIG. 7, a frontal view is shown of a suture anchor head 11 that includes eyelets having a parabolic shape in a cross section transverse to a suture anchor longitudinal axis A, in accordance with a further arrangement of the present disclosure. The anchor head 11 includes two eyelets 12 that are offset, or spaced apart, from one another a distance along the longitudinal axis A and also a distance in a direction transverse to the longitudinal axis A. Eyelets 12 include void regions 14 with openings 20 onto lateral surfaces 15 of the anchor head 11, similar to the other arrangements.

[0040] The void regions 14 of the eyelets 12 shown may include a variable cross section. For example, each void region 14 may include an outer region, indicated by surface 16, and an intermediate void region, indicated by surface 22. The outer void regions 16 may each have a defining surface that has a contoured or rounded shape, e.g., a segment of a desired conic surface. Each eyelet 12 may also include intermediate void regions 22, as shown, extending between the outer void regions 16 and the central void region 14. Defining surfaces of the intermediate void regions 22 for each eyelet 12 may be any suitable shape in cross section, e.g., circular cylindrical, elliptical, etc. [0041] With continued reference to FIG. 7, an eyelet 12 may include chamfered or radiused cut-outs 24 extending between the openings of the eyelet 12 and an end or top surface 26 of the anchor head 11. Such cut-outs 24 may help to increase the angle of approach for a suture threaded through the openings 20 of the eyelet 12 and reduce stresses on the suture. Preferably all edges of the anchor head 11 that may come into contact with a suture are rounded to further protect a sutures threaded through the eyelets 12. Example of such locations on an anchor head 11 include between the cut-outs 24 and the end surface 26, between the lateral surfaces 15 and the outer void regions 16, between the outer void regions 16 and the intermediate void regions 22, and between the intermediate void regions 22 and the central void region 14.

[0042] FIG. 8 is a sectional view of the anchor head 11 of FIG. 7 in the direction of cutting plane 8-8. Outer void regions 16 are shown extending between the lateral surfaces 15 of the anchor head 11 and intermediate void regions 22, which are located on opposing sides of the central void region 14. The outer void regions 16 may each have a defining surface that has a contoured or rounded shape, e.g., a segment of a desired conic surface. The intermediate and outer void regions may have respective central axes F and G. The outer void region surface 16 may have an included angle β, which may in some arrangements be positioned in a plane that includes suture-direction axis C (which is orthogonal to both the longitudinal A axis and lateral axis B of FIG. 7). The central axis F may extend an angle χ with respect to axis C and central axis G may extend at an angle α with the respect to axis C. The outer and intermediate void regions 16, 22 may be shaped as desired to achieve particular locations of the respective central axes F and G. Alternate angle α' and central axis F' show one example.

[0043] In preferred arrangements, the central axes F and G may extend within a plane formed by the longitudinal axis A and the suture-direction axis C. In preferred arrangements, α and χ are each equal to thirty degrees with respect to axis C, causing axes F and G to be collinear. In preferred arrangements, the surfaces of the outer void regions 16 each are shaped as a segment of a conic surface having an included angle β equal to about sixty degrees. In certain arrangements, the outer void regions 16 are shaped such that a cross-section of the [0054] FIGS. 16 and 17 show more detailed views of the drive socket shown in FIGS. 14 and 15. As shown, the drive socket 96 of the drive tool 90 may include inwardly facing surfaces 98 for gripping outwardly facing surfaces of the anchor head 28 of the suture anchor 10 for transferring torque from the drive tool 90 to the suture anchor 10. hi addition, the inwardly facing surfaces 98 include recesses 100 positioned for alignment with the outer void regions 20 of the eyelets 12 of the anchor 10 and sized to receive a suture 200 passing through the eyelet. In the arrangement shown, the drive socket 96 is permanently attached to the tube 94, but can be provided as removably attachable to the tube.

[0055] FIG. 18 shows another drive socket 196 constructed in accordance with a further arrangement of the present disclosure. The drive socket 196 is similar to the drive socket 96 of Figs. 11 and 12, but further includes at least two tabs 198 extending axially from a distal edge of the socket. The tabs 198 may be used for covering and protecting a suture (not shown) received in the anchor 10, while the anchor 10 is being screwed into a bone using the socket 196. As shown, the suture anchor 10 includes an axially extending recess 17 extending over each opening of the outer void regions of the eyelets 12 and the tabs 198 are aligned for receipt within the recesses 17 and adapted to receive a suture, e.g., suture 200, between the tabs 198 and the anchor 10, to mitigate damaging, e.g., crushing, of the suture between the socket 196 and the suture anchor 10.

[0056] The suture anchors, drill guide and drive tool described above can be included, individually or in any combination, as part of a surgical kit also including at least one length of suture (not shown) for a given suture anchor. The suture can be a monofilament or multifilament, braided suture. The suture may be bio-compatible and may be bio-absorbable if desired. In addition, one end of the length of suture may be deformed and shaped differently than the other end, such that a surgeon can distinguish the two ends of the suture length visually and by touch during a surgical procedure. For example, one end of the length of suture within the surgical kit can be deformed and shaped so that it is flat, while the other end is not deformed such that it remains cylindrical. [0057] Accordingly arrangements of the present disclosure address needs seen for the prior art by providing improved suture anchors and surgical kits including the same. By employing multiple eyelets that are offset from one another along an axis transverse to a longitudinal axis, anchor heads may have increased strength and resistance to shear failure, leading to overall improvements in strength for a suture anchor.

[0058] It should be understood that the presently disclosed suture anchors, drill guide, driver tool, and surgical kits, can be embodied in other specific forms without departing from the spirit or essential characteristics thereof. For example, suture anchors according to the present disclosure may be made of a suitable metal or plastic. Furthermore, plastics may be used that dissolve in a body in a harmless manner a suitable period after being secured therein, such that the suture anchors and sutures do not have to be removed by medical personnel. In addition, offset eyelets formed in accordance with the present disclosure can be formed in an insert for insertion into an anchor after the anchor has been fixed within a bone, as opposed to being formed directly in the anchor. Moreover, while the previous description has referred to suture anchors having two offset eyelets, a plurality of offset suture anchors of any numbers, e.g., three, four, etc., may be utilized for a suture anchor according to the present disclosure.

[0059] The present disclosure describing suture anchors and surgical kits, therefore, is to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of he equivalency of the claims are therefore intended to be embraced therein.

Claims

CLAIMSWhat is claimed is:

1. A suture anchor for securing soft tissue to bone, comprising:

a threaded body connected to an anchor head, the threaded body and anchor head extending along a longitudinal axis; and

a plurality of eyelets extending between opposing lateral surfaces of the anchor head for receiving multiple sutures, wherein each eyelet defines a void region that has a central axis, and wherein on a pair- wise basis the respective axes of the eyelets are offset along the longitudinal axis and in a direction transverse to the longitudinal axis.

2. A suture anchor according to claim 1, wherein each eyelet comprises two outer void regions, each outer void region extending from one of the lateral surfaces of the head, having a central axis forming an acute angle with the longitudinal axis, and having a surface shaped as a segment of a conic surface extending about the central axis of the outer void region and tapering inward towards the longitudinal axis, and a central void region extending between the outer void regions.

3. A suture anchor according to claim 2, wherein the central axis of each outer void region of an eyelet extends within a plane formed by the longitudinal axis and a suture- direction axis of the eyelet.

4. A suture anchor according to claim 2, wherein the central axes of the outer void regions extend at an angle of about sixty degrees with respect to the longitudinal axis.

5. A suture anchor according to claim 1, wherein the openings of each eyelet are elliptical in cross section parallel to the lateral surfaces.

6. A suture anchor according to claim 1, wherein the body includes cut-outs extending between openings of an eyelet and an end surface of the anchor head.

7. A suture anchor according to claim 6, wherein each of the cut-outs extends between corners formed by the end surface and a lateral surface of the anchor head.

8. A suture anchor according to claim 1, wherein the surfaces of the outer void regions each form a segment of a conic surface having an included angle of about sixty degrees.

9. A suture anchor according to claim 1, wherein the eyelets have central axes that are substantially parallel to one another.

10. A suture anchor according to claim 1, wherein an eyelet includes a counter bore.

11. A suture anchor according to claim 1 , wherein the threaded body is self- tapping.

12. A suture anchor according to claim 11, wherein the threaded body includes a self-drilling tip at the end of the body.

13. A suture anchor according to claim 1, made from bio-compatible material.

14. A suture anchor according to claim 1, made from bio-absorbable material.

15. A suture anchor according to claim 1, wherein a central void region of an eyelet is cylindrical.

16. A suture anchor according to claim 1, wherein an eyelet further includes intermediate void regions extending between respective outer void regions and a central void region.

17. A suture anchor according to claim 16, wherein the intermediate void regions are cylindrical.

18. A suture anchor according to claim 17, wherein central axes of the intermediate void regions extend at an angle of about sixty degrees with respect to the longitudinal axis of the body.

19. A suture anchor according to claim 1, wherein one eyelet has a central axis that is not a straight line.

20. A suture anchor according to claim 19, wherein the central axis is curved.

21. A kit including a suture anchor according to claim 1, and further comprising a drill guide having:

a handle;

a hollow guide shaft rotatably secured to the handle, the guide shaft having a tip and an alignment window adjacent the tip;

) an adjustment wheel radially extending from the shaft; and

a button positioned within the handle and movable to a locked position preventing rotation of the adjustment wheel.

22. A kit according to claim 21 , further including at least one length of suture.

23. A kit according to claim 22, wherein the suture is a monofilament.

24. A kit according to claim 23, wherein one end of the length of suture is deformed.

25. A kit according to claim 23, wherein the suture is bio-compatible.

26. A kit according to claim 25, wherein the suture is bio-absorbable.

27. A kit including a suture anchor according to claim 1, the kit further comprises a tubular drive tool having: a handle;

a tube extending from the handle to a distal end; and

a drive socket attached to the distal end of the tube and including inwardly facing surfaces for gripping outwardly facing surfaces of the drive head of the suture anchor for transferring torque from the drive tool to the suture anchor, and wherein the inwardly facing surfaces include recesses positioned for alignment with the outer void regions of the eyelet of the anchor and sized to receive a suture passing through the eyelet.

28. A kit according to claim 27, wherein the drive socket is removably attached to the tube.

29. A kit according to claim 27, further including at least one length of suture.

30. A kit according to claim 29, wherein the suture is a monofilament.

31. A kit according to claim 29, wherein one end of the length of suture is deformed.

32. A kit according to claim 29, wherein the suture is bio-compatible.

33. A kit according to claim 29, wherein the suture is bio-absorbable.

34. A kit according to claim 27, wherein the drive socket further includes at least two tabs extending axially from a distal edge of the socket.

35. A kit according to claim 34, wherein the suture anchor includes an axially extending recess extending over each opening of the outer void regions of the eyelet for receiving the tabs of the drive socket.