OBLONG CROSS-SECTIONAL TISSUE FIXATION PEG

• US 20100063541A1
• Filed: 09/05/2008
• Published: 03/11/2010
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: Synovis Orthopedic and Woundcare Incorporated (Baxter International Inc.)
• Original Assignee: Pegasus Biologies Incorporated
• Inventors: Weinstein, Al, Brunelle, John
• Granted Patent: US 9,089,415 B2
• Time in Patent Office: Days
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Abstract

Disclosed are fixation devices that can be utilized to approximate and hold a soft tissue in, at, or near a bony insertion site. Disclosed devices can define an oblong cross-section, and can include ribs defining sharp edges on the periphery of one aspect of the cross section that can tightly fix the device to surrounding bone so as to avoid pull out of the device. Devices can also include ribs defining rounded ridges on the periphery of a second, perpendicular aspect of the cross section that can allow soft tissue or a portion of an approximation device, for instance a soft tissue graft or cellular scaffolding material, to be fixed within a bone without damage to the soft tissue.

Claims

1. A tissue fixation device comprising a proximal end and a distal end and defining a longitudinal axis from the proximal end to the distal end, the tissue fixation device further defining a first cross sectional area along at least a portion of and perpendicular to the longitudinal axis, the first cross sectional area defining a periphery and including a first aspect having a first length and a second aspect that is perpendicular to the first aspect and having a second length, wherein the first length is greater than the second length such that the cross sectional area is oblong.

2. The tissue fixation device according to claim 1, further comprising a first rib extending from a first portion of the periphery of the first cross sectional area, the first portion of the periphery including the terminus of the first aspect, wherein the first rib defines a sharp edge.

3. The tissue fixation device according to claim 2, wherein the sharp edges are oriented toward the proximal end of the device.

4. The tissue fixation device according to claim 1, further comprising a second rib extending from a second portion of the periphery of the first cross sectional area, the second portion of the periphery including the terminus of the second aspect, wherein the second rib defines a rounded ridge.

5. The tissue fixation device according to claim 1, further defining a transverse aperture through the device, the transverse aperture being generally perpendicular to the longitudinal axis of the tissue fixation device.

6. The tissue fixation device according to claim 5, wherein the transverse aperture is aligned with the second aspect of the first cross sectional area.

7. The tissue fixation device according to claim 5, wherein the distance from the center of the transverse aperture to the distal end is less than the distance from the center of the transverse aperture to the proximal end.

8. The tissue fixation device according to claim 1, wherein the distal end defines a second cross sectional area that is smaller than the first cross sectional area.

9. The tissue fixation device according to claim 1, wherein the tissue fixation device is between about 5 millimeters and about 30 millimeters in length as measured from the proximal end to the distal end.

10. The tissue fixation device according to claim 1, wherein the first length is between about 2 millimeters and about 10 millimeters.

11. The tissue fixation device according to claim 1, wherein the second length is between about 1 millimeter and about 6 millimeters.

12. The tissue fixation device according to claim 1, further defining an inset in the proximal end configured to interface with a delivery mechanism.

13. The tissue fixation device according to claim 12, where in the inset is threaded.

14. The tissue fixation device according to claim 1, further defining a protrusion in the proximal end configured to interface with a delivery mechanism.

15. The tissue fixation device according to claim 1, wherein the tissue fixation device is sterile.

16. The tissue fixation device according to claim 1, wherein the first cross sectional area is an ellipse.

17. The tissue fixation device according to claim 1, wherein the first cross sectional area is a rectangle.

18. The tissue fixation device according to claim 1, further comprising two or more apertures that are generally perpendicular to the longitudinal axis.

19. The tissue fixation device according to claim 1, further comprising a first rib extending from a first portion of the periphery of the first cross sectional area, the first portion of the periphery including the terminus of the first aspect, wherein the first rib defines a sharp edge, the device also comprising a second rib extending from a second portion of the periphery of the first cross sectional area, the second portion of the periphery including the terminus of the second aspect, wherein the second rib defines a rounded ridge.

20. The tissue fixation device according to claim 19, wherein the first rib and the second rib are in the same cross sectional plane of the device.

21. The tissue fixation device according to claim 19, wherein the first rib and the second rib are offset from one another along the longitudinal axis.

22. The tissue fixation device according to claim 1, wherein at least a portion of the cross sectional area of the device tapers with respect to the longitudinal axis from the proximal to the distal end.

23. The tissue fixation device according to claim 1 in combination with a tissue approximation device, the tissue approximation device comprising a mechanical reinforcing component and a cellular scaffold component.

24. A method for repairing a soft tissue comprising:

passing a tissue approximation device that has been attached to a soft tissue through a transverse aperture of a fixation device, the fixation device defining a longitudinal axis between a proximal end and a distal end, the transverse aperture being generally perpendicular to the longitudinal axis, the tissue fixation device further defining a cross sectional perpendicular to the longitudinal axis, the cross sectional area defining a periphery and including a first aspect having a first length and a second aspect that is perpendicular to the first aspect and having a second length, wherein the first length is greater than the second length such that the cross sectional area is oblong;

placing the tissue approximation device on a first portion of the fixation device, the first portion of the fixation device including a terminus of the second aspect; and

inserting the fixation device into a bone hole or bone slot such that the tissue approximation device is between the fixation device and the tissue of the bone hole or bone slot.

25. The method according to claim 24, the fixation device further comprising a first rib extending from a second portion of the fixation device, the second portion of the fixation device including a terminus of the first aspect, wherein the first rib defines a sharp edge and upon insertion of the fixation device into the bone hole or bone slot, the sharp edge of the first rib is in contact with the surface of the bone hole or bone slot.

26. The method according to claim 24, the fixation device further comprising a second rib extending from the first portion of the fixation device, the second rib defining a rounded ridge, wherein upon insertion of the fixation device into the bone hole or bone slot, the tissue approximation device is held between the second rib and the tissue of the bone hole or bone slot.

27. The method according to claim 24, further comprising attaching a driver to the proximal end of the fixation device.

28. The method according to claim 24, wherein the tissue approximation device comprises suture.

29. The method according to claim 24, wherein the tissue approximation device comprises a cellular scaffold.

30. The method according to claim 29, wherein the cellular scaffold comprises collagen.

31. The method according to claim 24 wherein the tissue approximation device comprises a surgical mesh.

32. The method according to claim 24, wherein the tissue approximation device defines a length, the tissue approximation device defining a width greater than about 1 millimeter along at least a portion of the length, the tissue approximation device comprising a reinforcing component having a porosity and a tensile strength of at least about 20N, the tissue approximation device further comprising a cellular scaffold component attached to the reinforcing component.

33. A method for repairing a soft tissue comprising:

passing a tissue through a transverse aperture of a fixation device, the fixation device defining a longitudinal axis between a proximal end and a distal end of the fixation device, the transverse aperture being generally perpendicular to the longitudinal axis, the tissue fixation device further defining a cross sectional area perpendicular to the longitudinal axis, the cross sectional area defining a periphery and including a first aspect having a first length and a second aspect that is perpendicular to the first aspect and having a second length, wherein the first length is greater than the second length such that the cross sectional area is oblong;

placing the tissue over a first portion of the fixation device, the first portion of the fixation device including a terminus of the second aspect; and

inserting the fixation device into a bone hole or bone slot such that the tissue is held between the fixation device and tissue of the bone hole or bone slot.

34. The method according to claim 33, the fixation device further comprising a first rib extending from a second portion of the fixation device, the second portion of the fixation device including a terminus of the first aspect, wherein the first rib defines a sharp edge and upon insertion of the fixation device into the bone hole or bone slot, the sharp edge of the first rib is in contact with the tissue of the bone hole or bone slot.

35. The method according to claim 33, the fixation device further comprising a second rib extending from the first portion of the fixation device, the second rib defining a rounded ridge, wherein upon insertion of the fixation device into the bone hole or bone slot, the tissue is held between the second rib and the tissue of the bone hole or bone slot.

36. The method according to claim 33, further comprising attaching a driver to the proximal end of the fixation device.

37. The method according to claim 33, wherein the tissue is endogenous tissue.

38. The method according to claim 33, wherein the tissue is a tissue implant.

39. The method according to claim 38, wherein the tissue implant is natural tissue.

40. The method according to claim 38, wherein the tissue implant is synthetic tissue.