SUTURE HOLE GEOMETRY AND METHODS FOR ATTACHING TISSUE TO ORTHOPEDIC IMPLANTS

Abstract

Orthopedic implants and related surgical methods for using same. The implants have suture bore geometries that facilitate performance of the surgical methods, thereby providing for improved optimal biomechanical force application in various anatomies. The implants include suture bores that have an angled/diagonal, or skewed, orientation within the anatomical planes (lateral/sagittal and frontal/coronal). The suture bores have the skewed orientation so that the adjacent soft tissues (i.e., tendons or ligaments) can be advanced via the suture therethrough in superior-inferior and inferior-superior directions. Openings, or holes, at the ends of the suture bores are configured to approximate the adjacent associated soft tissue to the implant.

Claims

1. An implant comprising: a superior end, an inferior end opposite the superior end, a longitudinal axis extending between the superior and inferior ends; a first side extending between the superior and inferior ends, the first side being a lateral side; a second side opposite the lateral side and extending between the superior and inferior ends, the second side being a medial side; an anterior surface extending between the superior and inferior ends, and a posterior surface opposite the anterior surface and extending between the superior and inferior ends; a first suture hole formed in the posterior surface and a second suture hole formed in the lateral side; a first suture bore formed between the first and second suture holes and extending at a first acute angle with the longitudinal axis, and extending at a second acute angle with the longitudinal axis; a third suture hole formed in the lateral side and a fourth suture hole formed in the anterior surface; a second bore formed between the third and fourth suture holes and extending at the first acute angle with the longitudinal axis, and extending at the second acute angle with the longitudinal axis; and a first trough in the anterior surface and a second trough in the posterior surface.

2. The implant of claim 1, further comprising at least one third suture bore formed between the anterior and posterior surfaces.

3. The implant of claim 1, wherein the first acute angle and second acute angle are within a range of 0 degrees to 60 degrees.

4. The implant of claim 1, wherein the first acute angle and second acute angle are within a range of 10 degrees to 40 degrees.

5. The implant of claim 1, wherein the first acute angle and second acute angle are within a range of 15 degrees to 30 degrees.

6. The implant of claim 2, wherein the at least one third suture bore extends between the first trough and the second trough.

7. The implant of claim 1, wherein the first bore has an acute angle with the longitudinal axis in the sagittal plane.

8. The implant of claim 7, wherein the first bore has an acute angle with the longitudinal axis in the coronal plane.

9. The implant of claim 8, wherein the second bore has an acute angle with the longitudinal axis in the sagittal plane.

10. The implant of claim 9, wherein the second bore has an acute angle with the longitudinal axis in the coronal plane.

11. The implant of claim 10, wherein the acute angle of the second bore in the coronal plane is the same acute angle of the first bore in the coronal plane.

12. The implant of claim 11, therein the acute angle of the second bore in the sagittal plane is the same acute angle of the first bore in the sagittal plane.

13. The implant of claim 1, wherein the implant is a proximal tibia implant.

14. The implant of claim 1, wherein the implant is a proximal femur implant.

15. A method of attaching soft tissue to an implant, comprising providing the implant of claim 1, passing a suture though the first bore so that the suture exits the second suture hole, inserting the suture into the third suture hole and passing it through the second bore so that the suture engages soft tissue and the suture exits the fourth suture hole, and pulling the suture in a downward direction.

16. The method of claim 15, further comprising cross-stitching the suture through the soft tissue before inserting the suture into the third suture hole.

17. The method of claim 15, wherein the soft tissue is a tendon.

18. The method of claim 15, wherein the soft tissue if a ligament.

19. The method of claim 15, wherein the suture is pulled in a direction of a line of action of the soft tissue.

20. A method of attaching soft tissue to an implant, comprising providing the implant of claim 2, advancing a first suture through the first bore, engaging the suture with soft tissue, advancing the suture through the second bore, and advancing a second suture through the at least one third bore.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying figures, which are incorporated in and constitute a part of the specification, illustrate preferred embodiments of the invention and, together with the description, serve to explain the objects, advantages, and principles of the invention. Embodiments of the invention are in no way limited by the following figures:

[0013] FIG. 1A is an anterolateral top perspective view of a proximal femur implant according to a first embodiment of the present invention;

[0014] FIG. 1B is a lateral side view of the implant of FIG. 1A, looking medially, with a schematic representation of a surgical method according to an embodiment of the present invention;

[0015] FIG. 2A is an anterolateral top perspective view of a proximal tibia implant according to a second embodiment of the present invention;

[0016] FIG. 2B is an anterior view of the implant of FIG. 2A, looking posteriorly, with a schematic representation of a surgical method according to an embodiment of the present invention

[0017] FIG. 3 is an anterolateral top perspective view of a proximal femur implant according to a third embodiment of the present invention;

[0018] FIG. 4 is a top plan view thereof;

[0019] FIG. 5 is a rear elevation view thereof;

[0020] FIG. 6 is a left elevation view thereof;

[0021] FIG. 7A is a left elevation view thereof with a portion removed to provide a partial sectional view; and

[0022] FIG. 7B is a cross-sectional view of the implant of FIG. 7A, taken along line 7B-7B.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0023] The present invention includes orthopedic implants and related surgical methods for using same. As discussed further below, the implants are configured so that a surgeon performing a joint replacement (or similar) procedure using the implants can advance adjacent associated tissue (i.e., tendons and/or ligaments) in a superior-to-inferior and inferior-to-superior directions, which are generally parallel to and/or aligned with a line of action of such tissue. The tissue can thereby be restored to its approximate original anatomical position after being affixed to the implant.

[0024] Reference is made to FIGS. 1A and 1B, which illustrate a proximal femur implant 10 according to a first embodiment, and a related surgical method for using same. The implant illustrated in FIGS. 1A and 1B is for a patient's left proximal femur and the implant for a right proximal femur, while not shown, is a mirror-image thereof. As illustrated in FIGS. 1A and 1B and further discussed below, the implant 10 includes suture bores 28, 34 that have an angled/diagonal, or skewed, orientation within the anatomical planes (lateral/sagittal and frontal/coronal). The suture bores have the skewed orientation so that the adjacent soft tissues (i.e., tendons or ligaments) can be advanced via the suture therethrough in superior-inferior and inferior-superior directions. Openings, or holes, at the ends of the suture bores are configured to approximate the adjacent associated soft tissue to the implant.

[0025] With continued reference to FIGS. 1A and 1B, the proximal femur implant 10 includes a superior end 12, an inferior end 14 opposite the superior end 12, and a longitudinal axis L extending between the superior and inferior ends 12, 14. The implant 10 further includes a first, or medial, side 16 extending between the superior and inferior ends 12, 14, and a second, or lateral, side 18 opposite the first side 16 and extending between the superior and inferior ends 12, 14. An anterior surface 20 extends between the superior and inferior ends 12, 14, and a posterior surface 22 extends between the superior and inferior ends 12, 14, opposite the anterior surface 20.

[0026] The proximal femur implant 10 includes a plurality of suture holes. A first suture hole 24 is formed in the posterior surface 22 of the implant 10 between the superior and inferior ends 12, 14, and a second suture hole 26 is formed in the lateral side 18 of the implant 10 proximate the superior end 12. A first suture bore 28 is formed between the first and second suture holes 24, 26 and extends at a first acute angle A1 with the longitudinal axis L in the frontal/coronal plane, and extends at a second acute angle A2 with the longitudinal axis L in the lateral/sagittal plane. The implant 10 further includes a third suture hole 30 formed in the lateral side 18 proximate the superior end 12, and a fourth suture hole 32 is formed in the anterior surface 20 between the superior and inferior ends 12, 14. A second suture bore 34 is formed between the third and fourth suture holes 30, 32 and extends at the first acute angle A1 with the longitudinal axis L in the frontal/coronal plane (see FIG. 1A, in which an imaginary dashed line extends from the second suture bore 34 to help illustrate this angle), and extends at the second acute angle A2 with the longitudinal axis L in the lateral/sagittal plane (see FIG. 1B, in which an imaginary dashed line extends from the second suture bore 34 to help illustrate this angle).

[0027] In various embodiments, the first acute angle A1 and second acute angle A2 both range from 0 to 60 or from 10 to 40. In a preferred embodiment, both the first acute angle A1 and second acute angle A2 range from 15 to 30. In a more preferred embodiment, the first acute angle A1 is 25, and the second acute angle A2 is 20. The first acute angle A1 and second acute angle A2 are determined according to two criteria, namely, (1) an angle measurement that facilitates close alignment to the line of action of the soft tissue, and (2) an angle measurement that facilitates fitting the suture bore between other existing holes/features in the implant to avoid interference between the holes/features.

[0028] In the embodiments shown in FIGS. 1A and 1B the suture bores 28 and 34 have a diagonal, or skewed, orientation within the anatomical planes (lateral/sagittal and frontal/coronal). Other bore orientations (e.g., straight) are also possible and included in the scope of the invention. In various embodiments, the first and second bores 28, 34 can be curved if the implant 10 is cast or 3D-printed.

[0029] In various embodiments, the implant 10 includes additional suture bores. In some embodiments, one or more suture bores 36 extend between the anterior surface 20 and posterior surface 22. The suture bores 36 are used to secure (i.e., clamp) soft tissue (i.e., tendons or ligaments) against ingrowth/ongrowth surface(s) of the implant 10.

[0030] As illustrated in FIG. 1B, an exemplary surgical attachment method for securing the proximal femur implant 10 within a patient includes the steps of (1) inserting the suture S up through the first suture hole 24 and the first bore 28 (see arrow pointing at an upward angle); (2) urging the suture S out of the second suture hole 26 so that the suture S is positioned proximate the adjacent soft tissue T (e.g., a tendon or ligament); (3) cross-stitching the suture S through and behind the adjacent soft tissue T; (4) inserting the suture S down through the third suture hole 30 and the second bore 34 (see arrow pointing at a downward angle); (5) urging the suture S out of the fourth suture hole 32; and (6) pulling the adjacent soft tissue T down (see arrow pointing straight down) and tying the suture S off proximate the second/lateral side 18 of the proximal femur implant 10. In various alternate embodiments, the suture S may be tied off at other locations instead of the lateral side. In various embodiments, the suture S may be reversed and run back through the bore(s) and soft tissue T a second time, and any number of additional times, to provide additional anchorage for the implant 10. In various embodiments, the order in which these steps are performed may vary. Other modifications of the method by a surgeon are also envisioned.

[0031] Reference is now made to FIGS. 2A and 2B, which illustrate a proximal tibia implant 110 according to a second embodiment. The implant illustrated in FIGS. 2A and 2B is for a patient's left proximal tibia and the implant for a right proximal tibia, while not shown, is a mirror-image thereof. As illustrated in FIGS. 2A and 2B and further discussed below, the implant 110 includes suture bores 128, 134 that have an angled/diagonal, or skewed, orientation within the anatomical planes (lateral/sagittal and frontal/coronal). The suture bores have the skewed orientation so that the adjacent soft tissues (i.e., tendons or ligaments) can be advanced via the suture therethrough in superior-inferior and inferior-superior directions. Openings, or holes, at the ends of the suture bores are configured to approximate the adjacent associated soft tissue to the implant.

[0032] With continued reference to FIGS. 2A and 2B, the proximal tibia implant 110 includes a superior end 112, an inferior end 114 opposite the superior end 112, and a longitudinal axis L extending between the superior and inferior ends 112, 114. The implant 110 further includes a first (i.e., lateral or medial) side 116 extending between the superior and inferior ends 112, 114, and a second (i.e., medial or lateral), side 118 opposite the first side 116 and extending between the superior and inferior ends 112, 114. An anterior surface 120 extends between the superior and inferior ends 112, 114, and a posterior surface 122 extends between the superior and inferior ends 112, 114, opposite the anterior surface 120.

[0033] The proximal tibia implant 110 includes a plurality of suture holes. A first, suture hole 124 is formed in the first side 116 of the implant 110 between the superior and inferior ends 112, 114, and a second suture hole 126 is formed in the anterior surface 120 proximate the superior end 112 and first side 116. A first suture bore 128 is formed between the first and second suture holes 124, 126 and extends at a third acute angle A3 with the longitudinal axis L in the lateral/sagittal plane (see FIG. 2A, in which an imaginary dashed line extends from the first suture bore 128 to help illustrate this angle), and extends at a fourth A4 acute angle with the longitudinal axis L in the frontal/coronal plane (see FIG. 2B, in which an imaginary dashed line extends from the first suture bore 128 to help illustrate this angle). A third suture hole 130 is formed in the anterior surface 120 proximate the superior end 112 and second side 118, and a fourth suture hole 132 is formed in the second side 118 between the superior and inferior ends 112, 114. A second bore 134 is formed between the third and fourth suture holes 130, 132 and extends at the third acute angle A3 with the longitudinal axis L in the lateral/sagittal plane, and extends at the fourth acute angle A4 with the longitudinal axis L in the frontal/coronal plane.

[0034] In various embodiments, the third acute angle A3 and fourth acute angle A4 both range from 0 to 60 or from 10 to 40. In a preferred embodiment, both the third acute angle A3 and fourth acute angle A4 range from 15 to 30. In a more preferred embodiment, the third acute angle A3 is 28.7, and the fourth acute angle A4 is 18. The third acute angle A3 and fourth acute angle A4 are determined according to two criteria, namely, (1) an angle measurement that facilitates close alignment to the line of action of the soft tissue, and (2) an angle measurement that facilitates fitting the suture bore between other existing holes/features in the implant to avoid interference between the holes/features.

[0035] In the embodiments shown in FIGS. 2A and 2B the suture bores 128 and 134 have a diagonal, or skewed, orientation within the anatomical planes (lateral/sagittal and frontal/coronal). Other bore orientations (e.g., straight) are also possible and included in the scope of the invention. In various embodiments, the first and second bores 128, 134 can be curved if the implant 110 is cast or 3D-printed.

[0036] In various embodiments, the implant 110 includes additional suture holes. bores. In some embodiments, one or more suture bores 136 extend between the anterior surface 120 and posterior surface 122. The suture bores 136 are used to secure (i.e., clamp) the tissue T (i.e., tendons or ligaments) against the ingrowth/ongrowth surface(s) of the implant 110.

[0037] As illustrated in 2A and 2B, an exemplary surgical attachment method for securing the proximal tibia implant 110 within a patient includes the steps of (1) inserting the suture S up through the first suture hole 124 and the first bore 128 (see arrow pointing at an upward angle in FIG. 2B); (2) urging the suture S out of the second suture hole 126 so that the suture S is positioned proximate the adjacent soft tissue T (e.g., a tendon or ligament); (3) cross-stitching the suture S through and behind the adjacent soft tissue T; (4) inserting the suture S down through the third suture hole 130 and the second bore 134 (see arrow pointing at a downward angle in FIG. 2B); (5) urging the suture S out of the fourth suture hole 132; and (6) pulling the adjacent soft tissue T down (see arrow pointing straight down in FIG. 2B) and tying the suture S off proximate the anterior surface 120 of the proximal tibia implant 110. In various alternate embodiments, the suture S may be tied off at other locations. In various embodiments, the suture S may be reversed and run back through the bore(s) and soft tissue T a second time, and any number of additional times, to provide additional anchorage for the implant 110. In various embodiments, the order in which these steps are performed may vary. Other modifications of the method by a surgeon are also envisioned.

[0038] Referring again to FIGS. 1A, 1B, 2A and 2B, the suture bore geometries and methods of the present invention facilitate greater surface contact between the suture S and adjacent soft tissue T than the single band of typical surgical implants, suture holes and techniques. More particularly, the suture bore geometries and methods of the present invention enable the surgeon to form an X-shaped/crisscrossed pattern (see FIGS. 1B and 2B), similar to the orientation of a shoelace within a shoe, which provides greater surface contact between the suture S and soft tissue T, and also better/more evenly distributes stresses across the soft tissue.

[0039] Reference is now made to FIGS. 3-7B, which illustrate a proximal femur implant 210 as a third embodiment. The implant 210 as illustrated is for a patient's left proximal femur and the implant for a right proximal femur, while not shown, is a mirror-image thereof. The proximal femur implant 210 includes a superior end 212, an inferior end 214 opposite the superior end 212, and a longitudinal axis L extending between the superior and inferior ends 212, 214. The implant 210 further includes a first, or medial, side 216 extending between the superior and inferior ends 212, 214, and a second, or lateral, side 218 opposite the first side 216 and extending between the superior and inferior ends 212, 214. An anterior surface 220 extends between the superior and inferior ends 212, 214, and a posterior surface 222 extends between the superior and inferior ends 212, 214, opposite the anterior surface 220.

[0040] The proximal femur implant 210 includes first and second troughs 240 formed in the anterior surface 220 and posterior surface 222. The troughs 240 are further discussed below.

[0041] The proximal femur implant 210 includes a plurality of suture holes. Referring to FIGS. 3-7B, a first suture hole 224 is formed in the first trough 240 between the superior and inferior ends 212, 214. A second suture hole 226 is formed in the lateral side 218 proximate the superior end 212. A first suture bore 228 extends between the first and second suture holes 224, 226 at a first acute angle with the longitudinal axis in the frontal/coronal plane, and at a second acute angle with the longitudinal axis in the lateral/sagittal plane. A third suture hole 230 is formed in the lateral side 218 proximate the superior end 212. A fourth suture hole 232 is formed in the second trough 240 between the superior and inferior ends 212, 214. A second suture bore 234 extends between the third and fourth suture holes 230, 232 at the first acute angle with the longitudinal axis in the frontal/coronal plane, and at the second acute angle with the longitudinal axis in the lateral/sagittal plane.

[0042] As illustrated in FIGS. 7A and 7B, the first and second acute angles are 0. Thus, the first and second suture bores 228, 234 extend parallel to the longitudinal axis L, in a superior/inferior direction.

[0043] In various embodiments, the implant 210 includes additional suture bores, such as suture bores 236 formed between the first and second troughs 240 in the anterior and posterior surfaces 220 and 222. The troughs 240 decrease the length of the bores 236, which facilitates both manufacturing and cleaning. In other embodiments, the implant 210 does not include troughs, and the suture bores 236 are formed between the anterior and posterior surfaces 220 and 222 themselves (i.e., the end openings of the suture bores 236 are flush with the anterior and posterior surfaces 220 and 222).

[0044] An exemplary surgical attachment method for securing the proximal femur implant 210 within a patient includes same steps as described above in connection with the proximal femur implant 10.

[0045] The suture bore geometries and methods of the present invention allow the surgeon to optimally position and tighten the tissue against an implant surface during surgery, and subsequently provide a more ideal orientation of the tissue relative to the implant for optimal healing and functionality. The suture bore geometries and methods thereby provide a more ideal anchorage potential for biomechanical forces in limb salvage and orthopedic reconstruction.

[0046] The suture bore geometries and methods of the present invention enable the surgeon to advance/pull the suture downwardly, in an anatomical direction along the tissue's line of action as originally in the bone. This advantageously makes manipulation of the suture easier for the surgeon, as opposed to pulling the suture from the side, as disclosed in prior art implants and associated surgical methods.

[0047] The suture bore geometries and methods of the present invention enable the surgeon to optimally manipulate/position the tissue against an opposing smooth, integrated porous, or roughened surface treatment/coating on the implant and subsequently secure the tissue in opposition to the implant.

[0048] In various embodiments, the implants disclosed herein may be formed from any medically-acceptable/biocompatible material, including, but not limited to, metals, metal alloys, ceramics, plastics and polymers. Non-limiting examples of metals and metal alloys include CoCr (cobalt-chrome), titanium alloys and stainless steel. A non-limiting example of a polymer includes PEEK.

[0049] In various embodiments, the implants disclosed herein include an anti-microbial coating.

[0050] While proximal femur and proximal tibia implants and their respective suture hole geometries and methods have been disclosed herein, also included within the scope of the present invention are various embodiments of distal long bone implants, including, but not limited to, distal femur implants and distal tibia implants and the respective suture hole geometries and methods configured for such distal long bones.

[0051] In various embodiments, the implants, suture hole geometries and methods of the present invention may be used with other long bones (i.e., other than the femur and/or tibia). Such bones include, but are not limited to, the fibula, radius, humerus and/or ulna, or any other bones. In further various embodiments, the implants, suture hole geometries and methods of the present invention may be modified for use with other bones, such as those of the pelvis, skull, hand and foot.

[0052] In various embodiments, the suture bores may be formed in any plurality/number, and at various angles and positions. In various embodiments, the suture bores distally diverge and proximally converge to facilitate tissue attachment and manipulation, as described herein.

[0053] Modifications, additions, or omissions may be made to the systems, apparatuses, and methods described herein without departing from the scope of the disclosure. For example, the components of the systems and apparatuses may be integrated or separated. Moreover, the operations of the systems and apparatuses disclosed herein may be performed by more, fewer, or other components and the methods described may include more, fewer, or other steps. Additionally, steps may be performed in any suitable order. As used in this document, each refers to each member of a set or each member of a subset of a set.

[0054] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. Although specific advantages have been enumerated above, various embodiments may include some, none, or all of the enumerated advantages. It is intended that the embodiments described above be considered as exemplary only, with a true scope and spirit of the invention being indicated by the appended claims. Moreover, none of the features disclosed in this specification should be construed as essential elements, and therefore, no disclosed features should be construed as being part of the claimed invention unless the features are specifically recited in the claims. In addition, it should be understood that any of the features disclosed on any particular embodiment may be incorporated in whole or in part on any of the other disclosed embodiments.

[0055] In any interpretation of the claims appended hereto, it is noted that no claims or claim elements are intended to invoke or be interpreted under 35 U.S.C. 112(f) unless the words means for or step for are explicitly used in the particular claim.

[0056] In general, any combination of disclosed features, components and methods described herein is possible. Steps of a method can be performed in any order that is physically possible.

[0057] All cited references are incorporated by reference herein.

[0058] Although embodiments have been disclosed, it is not desired to be limited thereby. Rather, the scope should be determined only by the appended claims.

[0059] While various embodiment of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure, as set forth in the following claims.

[0060] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0061] Moreover, though the present disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.