Composite Implant for Surgical Repair
Disclosed are biocompatible implants that combine a scaffold material for supporting long term repair of a soft tissue with an elongated member such as a suture for aiding in placement of the scaffold during a surgical procedure as well as for immediate mechanical reinforcement of a repair site. The components of an implant are combined such that a longitudinal load placed upon a composite structure can be borne primarily by the elongated member and the scaffold material is isolated from the longitudinal load. Thus, the scaffold material of a composite can be protected from damage due to applied loads and stresses during and following a surgical procedure.
1 . A biocompatible implant comprising:
a scaffold that allows cellular ingrowth thereto; and
an elongated member affixed to the scaffold; wherein
the scaffold and the elongated member are held in contact with one another along a length of the scaffold and the elongated member extends from a surface of the scaffold.
2 . The biocompatible implant of claim 1 , wherein the elongated member has a tensile strength greater than that of the scaffold.
3 . The biocompatible implant of claim 1 , wherein a longitudinal load placed upon the implant along the axis of the elongated member is primarily borne by the elongated member.
4 . The biocompatible implant of claim 1 , wherein the scaffold comprises collagen.
5 . The biocompatible implant of claim 4 , wherein the scaffold comprises crosslinked collagen.
6 . The biocompatible implant of claim 5 , wherein the crosslinked collagen-containing scaffold is a non-glutaraldehyde processed collagen-containing scaffold.
7 . The biocompatible implant of claim 4 , wherein the scaffold comprises crosslinked reconstituted collagen.
8 . The biocompatible implant of claim 1 , wherein the elongated member is suture.
9 . The biocompatible implant of claim 1 , wherein the biocompatible implant comprises two or more scaffolds.
10 . The biocompatible implant of claim 9 , wherein the two or more scaffolds are twisted or braided together.
11 . The biocompatible implant of claim 1 , wherein the biocompatible implant comprises a plurality of elongated members.
12 . The biocompatible implant of claim 1 , wherein the elongated member is derived from a natural tissue.
13 . The biocompatible implant of claim 1 , wherein the elongated member comprises a woven fabric.
14 . The biocompatible implant of claim 13 , wherein the woven fabric covers the entire surface area of the scaffold.
15 . The biocompatible implant of claim 1 , wherein the implant has an aspect ratio of about 1 .
16 . The biocompatible implant of claim 1 , wherein the elongated member is non-pliable.
17 . The biocompatible implant of claim 1 , wherein the elongated member is woven through the scaffold.
18 . The biocompatible implant of claim 1 , wherein the elongated member is stitched to the scaffold.
19 . The biocompatible implant of claim 18 , the stitching comprising a locking stitch.
20 . The biocompatible implant of claim 1 , wherein the implant is sterile.
21 . The biocompatible implant of claim 1 , further comprising a reinforcement material covering at least a portion of the surface area of the scaffold.
22 . The biocompatible implant of claim 21 , wherein the reinforcement material comprises a fabric.
23 . The biocompatible implant of claim 1 , further comprising a biologically active agent incorporated in or on the implant.
24 . A method of forming a biocompatible implant comprising:
applying an elongated member to a scaffold that allows cellular ingrowth thereto such that the elongated member and the scaffold are held in contact along a length of the scaffold; and
affixing the elongated member to the scaffold such that at least one portion of the elongated member extends from the scaffold.
25 . The method according to claim 24 , wherein the step of affixing the elongated member to the scaffold comprises weaving the elongated member through the scaffold.
26 . The method according to claim 24 , wherein the step of affixing the elongated member to the scaffold comprises stitching the elongated member to the scaffold.
27 . The method according to claim 26 , wherein the stitching comprises forming a locking stitch.
28 . The method according to claim 24 , wherein the elongated member is affixed to the scaffold by use of a bioadhesive.
29 . The method according to claim 24 , further comprising braiding or twisting a plurality of scaffold to one another.
30 . The method according to claim 24 , the method further comprising forming the scaffold to a desired shape.
31 . The method according to claim 24 , the method further comprising forming a plurality of fenestrations or perforations in the scaffold at predetermined positions.
32 . The method according to claim 24 , wherein the elongated member is a length of suture.
33 . The method according to claim 24 , the method further comprising affixing a reinforcement material to at least a portion of the scaffold.
34 . The method according to claim 33 , wherein the reinforcement material is stitched to the scaffold.
35 . A method of delivering a biocompatible implant to a tissue comprising
applying a longitudinal force to an elongated member of an implant to manipulate the implant, the implant comprising the elongated member affixed to a scaffold that allows cellular ingrowth thereto, the scaffold and the elongated member being held in contact with one another along a length of the scaffold, the longitudinal force being applied to a portion of the elongated member that extends beyond a surface of the scaffold; and
attaching the biological implant to surrounding tissue.
36 . The method of claim 35 , wherein the scaffold is mechanically isolated from the longitudinal force applied to the elongated member.
37 . The method of claim 35 , wherein the elongated member is a suture.
38 . The method of claim 35 , wherein the tissue is soft tissue.
39 . The method of claim 38 , wherein the soft tissue is a ligament.
40 . The method of claim 38 , wherein the soft tissue is a tendon.
41 . The method of claim 35 , wherein the tissue is human soft tissue.