SUTURE ANCHOR WITH DRUG/GROWTH FACTOR DELIVERY RESERVOIR

• US 20090177229A1
• Filed: 12/29/2008
• Published: 07/09/2009
• Est. Priority Date: 01/03/2008
• Status: Abandoned Application

• Current Assignee: New York Society For The Ruptured and Crippled Manufacturing The Hospital For Special Surgery
• Original Assignee: New York Society For The Ruptured and Crippled Manufacturing The Hospital For Special Surgery
• Inventors: Lo, Darrick, Gulotta, Lawrence V., Lipman, Joseph David
• Application Number:
  US12/344,749
• Publication Number:
  US 20090177229A1
• 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 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A surgical device for use in attaching a first member (e.g., soft-tissue) to a second member (e.g., a bone) includes a suture anchor that has a body having a first end; a pointed tip at an opposite second end; and a contoured outer surface. An anchor head that is coupled to the body at the first end has an opening to permit attachment of one or more suture to the body. The suture anchor also includes a reservoir formed in the body and being open at the first end thereof and closed at an opposite end. The reservoir is configured to store and release at least one of a drug, a therapeutic agent, a growth factor, or a combination thereof from a top surface of the anchor body into a site of an interface between the first and second members to promote healing or therebetween or limit post-operative pain.

Claims

1. A suture anchor for use in attaching a first member to a second member comprising:

a body having a first end and an opposite pointed second end and a contoured outer surface;

a reservoir formed in the body and being open at the first end of the body and closed at an opposite end that is closer to the second end, the reservoir being configured to store and release at least one of a drug, therapeutic agent, and a growth factor toward an interface between the first and second members; and

a hollow head portion that extends from the first end of the body such that an entrance to the reservoir is accessible therethrough, the hollow head portion having an eyelet formed therein for receiving one or more sutures.

2. The suture anchor of claim 1, wherein the first member comprises soft tissue and the second member comprises a bone.

3. The suture anchor of claim 2, wherein the first member comprises a tendon.

4. The suture anchor of claim 1, wherein the anchor body and anchor head are formed of a biocompatible material.

5. The suture anchor of claim 4, wherein the biocompatible material includes at least one of a stainless steel, a titanium, a polymer, a bone, or an absorbable.

6. The suture anchor of claim 5, wherein the polymer includes at least one of a polyester, a nylon, a poly lactic acid (PLA), a poly-L lactic acid (PLLA), or a poly glycolic acid (PGA).

7. The suture anchor of claim 1, wherein the contoured outer surface includes spiral threads.

8. The suture anchor of claim 1, wherein the anchor head is configured so that a tool can engage outer surfaces thereof to drive and implant the suture anchor into the second member.

9. The suture anchor of claim 8, wherein the anchor head has a hexagonal shape.

10. The suture anchor of claim 1, wherein the eyelet is formed above an interface between the anchor body and the anchor head.

11. The suture anchor of claim 1, wherein the reservoir comprises a bore formed in the anchor body along its length and from the first end thereof.

12. The suture anchor of claim 11, wherein the bore has a cylindrical shape.

13. The suture anchor of claim 1, wherein a width of the anchor head is less than a width of the first end of the anchor body.

14. The suture anchor of claim 1, wherein the reservoir has a volume of about 50 microliter.

15. The suture anchor of claim 1, wherein at least one of a drug, therapeutic agent, and a growth factor is in liquid form and the anchor further includes a permeable membrane that covers the open first end of the reservoir.

16. The suture anchor of claim 15, wherein the membrane is formed of a resorbable material.

17. The suture anchor of claim 1, wherein the at least one of a drug, therapeutic agent, and a growth factor comprises growth factors that are incorporated into different microspheres with varying release profiles.

18. The suture anchor of claim 1, further including at least one additional reservoir formed in the anchor body, each of the reservoirs being separate from one another.

19. The suture anchor of claim 18, wherein the reservoirs are covered with resorbable membranes of varying profiles.

20. The suture anchor of claim 18, wherein the reservoirs are covered with resorbable membranes of varying thicknesses.

21. The suture anchor of claim 1, wherein the at least one of a drug, therapeutic agent, and a growth factor improves healing, limit inflammation or prevent pain.

22. The suture anchor of claim 21, wherein the at least one of a drug, therapeutic agent, and a growth factor is selected from the group consisting of:

antibiotics;

local anesthetics, such as bupivicaine and lidocaine;

anti-inflammatories; and

growth factors, such as bone morphogenetic proteins (BMPs), platelet-derived growth factors (PDGF), basic fibroblast growth factor (bFGF), growth hormone (GH), insulin growth factor (IGF), transforming growth factor (TGF), and hepatocyte growth factor (HGF).

23. The suture anchor of claim 1, wherein a hollow interior section of the anchor head is accessible through an opening along a top surface of the anchor head and is axially aligned with the reservoir.

24. A surgical device for use in attaching a first member to a second member comprising:

a suture anchor including;

a body having a first end that includes a hollow anchor head;

a pointed tip at an opposite second end; and

a contoured outer surface, the anchor head having an opening to permit attachment of one or more sutures to the body; and

a reservoir formed in the body and being open at the first end thereof and closed at an opposite end, the reservoir being configured to store and release at least one of a drug, a therapeutic agent, and a growth factor from a top surface of the anchor body into a site of an interface between the first and second members to promote healing therebetween.

25. The surgical device of claim 24, wherein the first member comprises soft-tissue and the second member comprises a bone.

26. The surgical device of claim 24, wherein the top surface of the anchor body includes an opening that forms an entrance into the reservoir to permit the at least one of a drug, therapeutic agent, and a growth factor to migrate through the opening to the site.

27. The surgical device of claim 24, wherein the body and anchor head are an integral, unitary structure.

28. The surgical device of claim 24, wherein the reservoir stores a sustained release drug delivery gel, the gel being formed of a composition selected from the group consisting of:

hydrogels, microspheres, lipospheres, collagen sponges, fibrin glue, bone cements, ceramics, and polymers;

the drug, growth factor or therapeutic agent being embedded into the composition.

29. A method for delivering a drug, a growth factor or a therapeutic agent to a location where soft tissue contacts a bone comprising the steps of:

providing a suture anchor including a body having a pointed distal tip, a contoured outer surface, and an anchor head portion that includes an opening to permit attachment of one or more sutures to the body, the body having a reservoir formed therein and being open along a top surface of the anchor;

disposing a drug, a therapeutic agent, a growth factor, or a combination thereof in the reservoir; and

implanting the suture anchor in the bone such that the top surface faces the location where the soft tissue contacts the bone resulting in the drug, therapeutic agent, or growth factor being released from the top surface of the suture anchor and migrating in a direction toward an interface between the soft tissue and bone.