TENDON REPAIR IMPLANT AND METHOD OF ARTHROSCOPIC IMPLANTATION

摘要

A tendon repair implant for treatment of a partial thickness tear in the supraspinatus tendon of the shoulder is provided. The implant may incorporate features of rapid deployment and fixation by arthroscopic means that compliment current procedures; tensile properties that result in desired sharing of anatomical load between the implant and native tendon during rehabilitation; selected porosity and longitudinal pathways for tissue in-growth; sufficient cyclic straining of the implant in the longitudinal direction to promote remodeling of new tissue to tendon-like tissue; and, may include a bioresorbable construction to provide transfer of additional load to new tendon-like tissue and native tendon over time.

主权项

1. A tendon repair implant for repair of a tendon, the tendon repair implant comprising:
an elongated sheet-like structure formed of reconstituted collagen material, the sheet-like structure having a first compact configuration for delivery from an arthroscopic instrument and a second planar configuration having a longitudinal dimension, a lateral dimension, and a thickness dimension and configured to be affixed to a surface of the tendon such that the longitudinal dimension of the sheet-like structure extends parallel to a load bearing direction of the tendon; wherein the reconstituted collagen material has a longitudinal alignment of collagen fibers forming longitudinal pathways extending along the longitudinal dimension of the sheet-like structure in the thickness dimension for at least some tissue in-growth oriented in the longitudinal direction, the longitudinal pathways having a cross-section width of 150 microns to 200 microns; wherein the sheet-like structure has an initial tensile modulus in the longitudinal dimension of 1 MPa to 10 MPa in the range of 1% to 3% strain prior to implantation, where 0% strain is defined with a 1 N preload applied to the sheet-like structure; wherein the sheet-like structure has an initial compressive modulus of at least 0.1 MPa; wherein the sheet-like structure is configured to have an initial load share representing between 1% to 50% of an anatomical load applied to the tendon and the sheet-like structure at the time that the sheet-like structure is affixed to the tendon.