# US 10,441,677 B2 · Methods and compositions for treating tendon degeneration

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- Number: US 10,441,677 B2
- Document ID: US10441677B2
- Status: Granted
- Kind: B2
- Application number: 15/497,577
- Filed: 2017-04-26
- Published: 2017-11-16
- Granted: 2019-10-15
- Earliest claimed: 2016-04-27
- Assignees: Anika Therapeutics, Inc.
- Applicants: Anika Therapeutics, Inc.
- Inventors: Colin D. White; Edward S. Ahn; Sekoni Daouda Noel
- Web page: https://patentgrep.com/patent/US10441677B2

## CPC

- A61L 27/20: Polysaccharides
- A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61L 27/386: {Ligaments, tendons}
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/04: for non-specific disorders of the connective tissue
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/10: for reconstruction of tendons or ligaments
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Injectable compositions and methods for treating an injured tendon in an animal or human are disclosed herein. The injectable compositions include an effective amount of a carbohydrate to increase osteotendinous hydration and lubrication.

## Claims

### Claim 1

A method for stabilizing, ameliorating, or remedying an injured tendon in an animal or a human in need thereof, the method comprising administering an injectable composition comprising a carbohydrate to the animal or the human, wherein
said composition comprises an effective amount of carbohydrate to increase tendon hydration and lubrication at the osteotendinous junction;
said composition is administered via intra-osteotendinous injection at zone one, zone two, zone three, or zone four of the osteotendinous junction; and
wherein said carbohydrate comprises hyaluronic acid, or an ester, acylurea, acyl isourea, disulfide, or amide thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein said carbohydrate contains at least one functional group selected from the group consisting of thiols, alcohols, amines, carboxyl groups, aldehydes, amides, esters, ketones, and combinations thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein said carbohydrate has a molecular mass of about 1,000,000 to about 3,000,000 Daltons.

### Claim 4 (depends on 1)

The method of claim 1, wherein said carbohydrate is not cross-linked.

### Claim 5 (depends on 1)

The method of claim 1, wherein said carbohydrate comprises at least one cross-link.

### Claim 6 (depends on 1)

The method of claim 1, wherein said carbohydrate is present in said composition at a concentration of about 5-30 mg/mL.

### Claim 7 (depends on 1)

The method of claim 1, wherein the composition further comprises a recombinant protein.

### Claim 8 (depends on 1)

The method of claim 1, wherein the composition further comprises a small molecule.

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition further comprises a somatic cell, platelet rich plasma (PRP), platelet poor plasma (PPP), stem cell allografts, stem cell autografts, bone marrow aspirate (BMA), bone marrow aspirate concentrate (BMAC), autologous fibroblast, or autologous myoblasts.

### Claim 10 (depends on 1)

The composition of claim 1, wherein said carbohydrate further comprises collagen, gelatin, a polysaccharide, or combinations thereof.

### Claim 11 (depends on 10)

The method of claim 10, wherein said carbohydrate further comprises a polysaccharide.

### Claim 12 (depends on 11)

The method of claim 11, wherein said polysaccharide is selected from the group consisting of dextran, heparan, heparin, alginate, agarose, carrageenan, amylopectin, amylose, glycogen, starch, cellulose, chondroitin, dermatan, keratan, chitin, chitosan, carboxymethyl cellulose (“CMC”), xanthan gum, gellan gum, galactomannan, and combinations thereof.

### Claim 13 (depends on 1)

The method of claim 1, wherein said hyaluronic acid is selected from the group consisting of hyaluronan, sodium hyaluronate, potassium hyaluronate, magnesium hyaluronate, calcium hyaluronate, ammonium hyaluronate, and combinations thereof.

### Claim 14 (depends on 13)

The method of claim 13, wherein said hyaluronic acid comprises a hyaluronic ester.

### Claim 15 (depends on 13)

The method of claim 13, wherein said hyaluronic acid comprises a hyaluronic amide.

### Claim 16 (depends on 1)

The method of claim 1, wherein said osteotendinous junction exhibits at least one degenerative characteristic selected from the group consisting of (i) an increase in Collagen III relative to normal tendon, (ii) a decrease in Collagen I relative to normal tendon, (iii) an increased observation of micro-tearing relative to normal tendon, (iv) an increase in disorganization of collagen micro-network relative to normal tendon, (v) an increase in fibroblastic infiltration relative to normal tendon, (vi) an increase in cell rounding relative to normal tendon, (vii) an increase in angiogenesis relative to normal tendon, (viii) an increase in cellularity relative to normal tendon, (ix) an increase in tendon gliding resistance relative to normal tendon, and (x) a dull gray appearance relative to normal tendon.

### Claim 17 (depends on 1)

The method of claim 1, wherein administration of the composition biomechanically reduces biomechanical interference.

### Claim 18 (depends on 1)

The method of claim 1, wherein said composition is injected at a site distal from the musculotendinous junction.

### Claim 19 (depends on 1)

The method of claim 1, wherein the composition is not administered via peri-musculotendinous or intra-musculotendinous injection.

### Claim 20 (depends on 1)

The method of claim 1, wherein said method comprises a plurality of injections of said composition at different times.

### Claim 21 (depends on 20)

The method of claim 20, wherein the method comprises a first injection of said composition and a second injection of said composition, wherein the second injection is administered five to ten days after the first injection.

### Claim 22 (depends on 1)

The method of claim 1, wherein the method further comprises post-injection joint manipulation or massage immediately following injection, or one week to six months post-injection, or one week to five months post-injection, or one week to four months post-injection.

### Claim 23 (depends on 1)

The method of claim 1, wherein the injured tendon exhibits increased pain compared to the tendon of a non-affected patient.

### Claim 24 (depends on 23)

The method of claim 23, wherein the increased pain is assessed using a scale selected from the group consisting of Visual Analog Scale (VAS), Disabilities of the Arm, Shoulder, and Hand (DASH), and Patient-Related Tennis Elbow Evaluation (PRTEE).