# US 10,864,072 B2 · Tendon repair implant and method of arthroscopic implantation

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,864,072 B2
- Document ID: US10864072B2
- Status: Granted
- Kind: B2
- Application number: 16/150,927
- Filed: 2018-10-03
- Published: 2019-01-31
- Granted: 2020-12-15
- Earliest claimed: 2010-03-11
- Assignees: Rotation Medical, Inc.
- Applicants: Rotation Medical, Inc.
- Inventors: Craig Van Kampen; Nathaniel Zenz-Olson; Thomas A. Westling; Charles L. Euteneuer
- Web page: https://patentgrep.com/patent/US10864072B2

## CPC

- A61F 2/08: Muscles; Tendons; Ligaments
- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61F 2/0805: {Implements for inserting tendons or ligaments}
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2002/0068: {having a special mesh pattern}
- A61F 2002/0894: {Muscles}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0057: stretchable
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2230/0019: rectangular
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61F 2310/00371: Collagen
- A61L 27/24: Collagen
- A61L 27/3662: {Ligaments, tendons}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 27/58: Materials at least partially resorbable by the body
- A61L 2430/10: for reconstruction of tendons or ligaments
- A61L 2430/30: for muscle reconstruction
- A61L 2430/34: for soft tissue reconstruction
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

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 an arthroscopic approach 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.

## Claims

### Claim 1

A method of repairing a tendon, the method comprising:
arthroscopically delivering a sheet-like implant to a surface of the tendon with the sheet-like implant in a first compact configuration, the sheet-like implant having a longitudinal dimension, a lateral dimension, and a thickness dimension, the sheet-like implant having an initial tensile modulus in the longitudinal dimension of 1 MPa to 50 MPa in a range of 1% to 3% strain in the longitudinal dimension, where 0% strain is defined with a 1 N preload applied to the sheet-like implant, the sheet-like implant formed of reconstituted collagen material having a porosity of 30% to 90% for tissue in-growth, wherein the reconstituted collagen material has a longitudinal alignment of collagen fibers which form longitudinal pathways extending along the longitudinal dimension of the sheet-like implant;
deploying the sheet-like implant by transforming the sheet-like implant to a second configuration wherein a surface of the sheet-like implant faces the surface of the tendon;
contacting and conforming the surface of the sheet-like implant to the surface of the tendon with the longitudinal dimension aligned with a load bearing direction of the tendon; and
affixing the sheet-like implant to the surface of the tendon without using sutures;
wherein upon initially affixing the sheet-like implant to the surface of the tendon, an anatomical load on the tendon and sheet-like implant combination is distributed with 1% to 50% of the anatomical load carried by the sheet-like implant.

### Claim 2 (depends on 1)

The method of claim 1, wherein upon initially affixing the sheet-like implant to the surface of the tendon, the anatomical load on the tendon and sheet-like implant combination is distributed with 5% to 33% of the anatomical load carried by the sheet-like implant.

### Claim 3 (depends on 1)

The method of claim 1, wherein upon initially affixing the sheet-like implant to the surface of the tendon, the sheet-like implant carries between 0.5 N to 50 N of the anatomical load.

### Claim 4 (depends on 1)

The method of claim 1, wherein upon initially affixing the sheet-like implant to the surface of the tendon, the sheet-like implant carries between 0.5 N to 25 N of the anatomical load.

### Claim 5 (depends on 1)

The method of claim 1, wherein the affixing step includes affixing a first portion of the sheet-like implant to the tendon on a muscle side of a tear and affixing a second portion of the sheet-like implant to a tuberosity side of the tear.

### Claim 6 (depends on 5)

The method of claim 5, wherein the tear is a partial thickness tear.

### Claim 7 (depends on 6)

The method of claim 6, wherein the tear extends through less than 50% of a thickness of the tendon.

### Claim 8 (depends on 1)

The method of claim 1, wherein the sheet-like implant is configured such that tissue grown within the longitudinal pathways will experience tendon-like strain when the sheet-like implant is subjected to longitudinally elongating loads following implantation.

### Claim 9 (depends on 1)

The method of claim 1, wherein the sheet-like implant is configured to degrade in tensile strength from an initial tensile strength thereby sharing less of the anatomical load over time.

### Claim 10 (depends on 1)

The method of claim 1, wherein the longitudinal dimension is greater than the lateral dimension and the thickness dimension.

### Claim 11 (depends on 1)

The method of claim 1, wherein the longitudinal dimension is in a range of 20 mm to 32 mm, the lateral dimension is in the range of 14 mm to 24 mm, and the thickness dimension is in the range of 0.5 mm to 2.5 mm.

### Claim 12 (depends on 1)

The method of claim 1, wherein the sheet-like implant has a maximum of 0.5% creep over three months.

### Claim 13 (depends on 1)

The method of claim 1, wherein the sheet-like implant has a compressive modulus greater than the tendon to allow for cyclic straining of the sheet-like implant and tissue in-growth.

### Claim 14 (depends on 13)

The method of claim 13, wherein the compressive modulus is at least 0.2 MPa.

### Claim 15

A method of repairing a tendon, the method comprising:
arthroscopically delivering a sheet-like implant to a surface of the tendon with the sheet-like implant inserted in a tubular member in a collapsed configuration, the sheet-like implant having a longitudinal dimension, a lateral dimension, and a thickness dimension, the sheet-like implant having an initial tensile modulus in the longitudinal dimension of 1 MPa to 50 MPa in a range of 1% to 3% strain in the longitudinal dimension, where 0% strain is defined with a 1 N preload applied to the sheet-like implant, the sheet-like implant formed of reconstituted collagen material having a porosity of 30% to 90% for tissue in-growth, wherein the reconstituted collagen material has a longitudinal alignment of collagen fibers forming longitudinal pathways extending along the longitudinal dimension of the sheet-like implant;
deploying the sheet-like implant from the tubular member along the surface of the tendon;
unfolding the sheet-like implant to a flattened configuration with a surface of the sheet-like implant facing the surface of the tendon;
conforming the surface of the sheet-like implant to the surface of the tendon with the longitudinal dimension aligned with a load bearing direction of the tendon; and
affixing the sheet-like implant to the surface of the tendon across a tear in the tendon.

### Claim 16 (depends on 15)

The method of claim 15, wherein upon initially affixing the sheet-like implant to the surface of the tendon, an anatomical load on the tendon and sheet-like implant combination is distributed with 1% to 50% of the anatomical load carried by the sheet-like implant.

### Claim 17 (depends on 15)

The method of claim 15, wherein upon initially affixing the sheet-like implant to the surface of the tendon, the sheet-like implant carries between 0.5 N to 50 N of the anatomical load.

### Claim 18 (depends on 15)

The method of claim 15, wherein upon initially affixing the sheet-like implant to the surface of the tendon, the sheet-like implant carries between 0.5 N to 25 N of the anatomical load.

### Claim 19 (depends on 15)

The method of claim 15, wherein the affixing step includes affixing a first portion of the sheet-like implant to the tendon on a muscle side of the tear and affixing a second portion of the sheet-like implant to a tuberosity side of the tear.

### Claim 20 (depends on 15)

The method of claim 15, wherein the tear is a partial thickness tear extending through less than 50% of a thickness of the tendon.

### Claim 21 (depends on 15)

The method of claim 15, wherein the sheet-like implant is configured to degrade in tensile strength from an initial tensile strength thereby sharing less of the anatomical load over time.
