System and method for attaching soft tissue to bone

• US 9,414,835 B1
• Filed: 05/25/2016
• Issued: 08/16/2016
• Est. Priority Date: 06/02/2004
• Status: Active Grant

• Current Assignee: Scott W. Tate
• Original Assignee: KFX Medical, LLC
• Inventors: Green, Michael L., Tauro, Joseph C., Bojanowski, Bart
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US15/164,671
• Time in Patent Office: 83 Days
• US Class Current: 1/1
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0408 Rivets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0422 by insertion of a separate member into the body of the anchor
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0817 Structure of the anchor

Abstract

Methods and devices for securing soft tissue to a rigid material such as bone are disclosed herein. A bone anchor is described that comprises a base and a top such that suture material may be compressed between surfaces on the base and top to secure the suture to the anchor. Also described is an inserter that can be used to insert the bone anchor into bone and move the anchor top relative to the anchor base to clamp suture material there between. Also described is a soft-tissue and bone piercing anchor and associated inserter. Methods are described that allow use of the bone anchors to provide multiple lengths of suture material to compress a large area of soft tissue against bone.

Claims

1. A bone implant, comprising:

an elongated hollow member; and

a tip member having a longitudinal axis, wherein the tip member comprises

a distal portion that tapers from proximal to distal, wherein the distal portion has a first dimension transverse to the longitudinal axis that is maximum at its proximal end and wherein the distal portion is configured to pierce through bone,

a middle portion having a second dimension transverse to the longitudinal axis that is constant along the middle portion'"'"'s length, wherein the middle portion comprises a suture aperture, and

a proximal portion having a third dimension transverse to the longitudinal axis that is constant along the proximal portion'"'"'s length and smaller than the second dimension, wherein the proximal portion is configured to be positioned within a distal portion of the elongated hollow member and not extend to a proximal end of the elongated hollow member,

wherein the tip member has a length that is shorter than the length of the elongated hollow member, and

wherein the elongated hollow member has an inner dimension transverse to its length that is smaller than the maximum first dimension.

2. The bone implant of claim 1, wherein the second dimension is smaller than the maximum first dimension and there is no tip member portion between the middle portion and the distal portion that has a dimension transverse to the longitudinal axis that is smaller than the maximum first dimension.

3. The bone implant of claim 1, wherein the suture aperture is transverse to the longitudinal axis.

4. The bone implant of claim 1, wherein the proximal portion is configured to couple to an inserter.

5. The bone implant of claim 1, further comprising a suture threaded through the suture aperture and extending through the elongated hollow member.

6. The bone implant of claim 1, wherein the tip member is positioned distally of the elongated hollow member.

7. The bone implant of claim 1, wherein the elongated hollow member comprises a plurality of openings in a sidewall thereof.

8. The bone implant of claim 1, wherein the distal end of the proximal portion of the tip member has a circular cross section.

9. An inserter and bone implant combination, comprising:

an inserter, comprising;

a handle,

an outer sleeve coupled to the handle, and

an inner tube disposed within the outer sleeve; and

a bone implant coupled to the inserter, the bone implant comprising;

an elongated hollow member, and

a tip member having a longitudinal axis, wherein the tip member comprises;

a distal portion that tapers from proximal to distal, wherein the distal portion has a first dimension transverse to the longitudinal axis that is maximum at its proximal end and wherein the distal portion is configured to pierce through bone,

a middle portion having a second dimension transverse to the longitudinal axis that is constant along the middle portion'"'"'s length, wherein the middle portion comprises a suture aperture, and

a proximal portion having a third dimension transverse to the longitudinal axis that is constant along the proximal portion'"'"'s length and smaller than the second dimension,

wherein a portion of the inner tube extends distally through the elongated hollow member and contacts the tip member,

wherein the proximal portion of the tip member is configured to be positioned within a distal portion of the elongated hollow member and not extend to a proximal end of the elongated hollow member and is removably coupled to the inserter,

wherein the length of the tip member is shorter than the length of the elongated hollow member,

wherein the elongated hollow member has an inner dimension transverse to its length that is smaller than the maximum first dimension, and

wherein a distal end of the outer sleeve is flush with an open, proximal end of the elongated hollow member.

10. The inserter and bone implant combination of claim 9, further comprising a suture coupled to the bone implant.

11. The inserter and bone implant combination of claim 10, wherein the suture extends through an axial bore in the inner tube and an axial bore in the handle of the inserter and exits the inserter through a hole in a proximal end of the handle.

12. The inserter and bone implant combination of claim 11, wherein the handle comprises a spool and wherein the suture exiting the hole in the proximal end of the handle is wrapped around the spool.

13. The inserter and bone implant combination of claim 9, wherein the elongated hollow member is not rotatable relative to the inner tube.

14. The inserter and bone implant combination of claim 9, wherein the inserter comprises a suture holder configured to hold excess suture, and wherein suture material passes through the suture aperture of the bone implant and is wrapped around the suture holder.

15. The inserter and bone implant combination of claim 9, wherein the inserter comprises a deployment actuator, wherein actuation of the deployment actuator causes the inner tube to move axially relative to the outer sleeve.

16. The inserter and bone implant combination of claim 9, wherein the inner tube is not fixedly attached to the tip member.

17. A method of fixating a bone implant within bone, comprising:

grasping the handle of the inserter and bone implant combination of claim 9;

piercing bone with the tip member;

moving the inner tube relative to the outer sleeve;

detaching the bone implant from the inserter; and

withdrawing the inserter from the bone, such that the suture material and the bone implant remain within the bone.

18. The method of claim 17, wherein the inner tube pushes against the tip member while piercing bone with the tip member.

19. The method of claim 17, wherein moving the inner tube relative to the outer sleeve moves the distal portion of the tip member closer to a proximal end of the elongated hollow member.

20. The method of claim 17, wherein piercing bone with the tip member comprises tapping on the inserter with a hammer.