Biostaples suitable for wrist, hand and other ligament replacements or repairs
The disclosure describes implantable medical products, that include dry or partially hydrated biocompatible biostaples suitable for ligament repairs or replacements comprising collagen fibers that may be configured to expand in situ after implantation to frictionally engage a bone tunnel wall or bone sleeve to thereby affix the construct in the bone tunnel.
1. An implantable biostaple comprising:
a body including a crown and two opposing outwardly extending legs with the crown bridging between the legs, wherein ex vivo the body is a self-supported substantially U-shaped body,
wherein the biostaple has at least one bundle of collagen fibers comprising about 2 to about 400 elongate collagen fibers that extend across the crown and over a length of each of the legs, and
wherein a majority of the elongate collagen fibers are substantially parallel to each other over at least a major portion of the length of the biostaple.
2. The implantable biostaple of claim 1 , wherein the two opposing outwardly extending legs expand in situ after implantation to frictionally engage a bone tunnel wall or sleeve to thereby affix the biostaple in the bone tunnel.
3. The implantable biostaple of claim 1 , wherein the biostaple is dry or partially hydrated at implantation.
4. The implantable biostaple of claim 1 , wherein the two opposing outwardly extending legs are sized to reside in a bone tunnel that is between about 5-10 mm long.
5. The implantable biostaple of claim 1 , wherein, in a fully hydrated unconstrained state, when measured ex vivo, the biostaple increases in cross-sectional area, on average, at least about 10%, and has a substantially constant length relative to a dry or partially hydrated state.
6. The implantable biostaple of claim 1 , wherein the biostaple is an implant for a collateral ligament for the hand or wrist.
7. The implantable biostaple of claim 1 , wherein the biostaple is an implant for a medial ulnar collateral ligament.
8. The implantable biostaple of claim 1 , wherein the biostaple is an implant for a scapholunate ligament.
9. The implantable biostaple of claim 1 , wherein each of the two opposing outwardly extending legs has an end portion with a leading beveled edge, and wherein at least a portion of each leg expands after implantation in a direction that is substantially orthogonal to an axial direction of the fibers in vivo to frictionally engage a sleeve or a wall of a bone tunnel of a patient.
10. The implantable biostaple of claim 1 , wherein the elongate collagen fibers are NDGA polymerized collagen fibers.
11. The implantable biostaple of claim 1 , wherein the at least one bundle of collagen fibers comprises about 10 to about 200 elongate collagen fibers.