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Last Updated: September 18, 2021

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Claims for Patent: 10,071,143

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Summary for Patent: 10,071,143
Title:Methods for non-surgical treatment of carpal tunnel syndrome
Abstract: Provided is a non-surgical method of treatment of carpal tunnel syndrome by administering an effective amount of purified collagenase I and II by injection onto a transverse carpal ligament, without penetrating the transverse carpal ligament. The purified collagenase I and II are obtained from Clostridium histolyticum, and the effective amount is a dose comprising a concentration of approximately 0.29 mg of the purified collagenase I and II to one ml diluent.
Inventor(s): Badalamente; Marie A. (Mount Sinai, NY), Wang; Edward (Poquott, NY)
Assignee: The Research Foundation for The State University of New York (Albany, NY)
Application Number:14/988,205
Patent Claims:1. A non-surgical method of treating carpal tunnel syndrome in a subject in need thereof, the method comprising: administering by injection, an effective amount of purified collagenase onto a transverse carpal ligament of the subject, wherein the effective amount of the purified collagenase is at least 0.58 mg/ml with a specific activity of at least 1500 SRC units, wherein the purified collagenase is obtained from Clostridium histolyticum and comprises collagenase I and II, and wherein the collagenase is administered with a blunt needle.

2. The method of claim 1, wherein the collagenase is injected in a liquid pharmaceutically acceptable carrier.

3. The method of claim 1, wherein the effective amount of the purified collagenase is injected between three and six sites onto a palmar side of the transverse carpal ligament of the subject.

4. The method of claim 1, wherein the injection is onto the transverse carpal ligament, without penetrating the transverse carpal ligament.

5. The method of claim 1, wherein the injection is performed with ultrasound guidance to avoid penetration of the transverse carpal ligament.

6. The method of claim 1, wherein the purified collagenase functions to rupture the transverse carpal ligament.

7. The method of claim 1, wherein an anesthetic is injected prior to administration of the collagenase, and wherein the injection of the anesthetic makes a needle track.

8. The method of claim 7, wherein the collagenase is administered following the needle track.

9. The method of claim 2, wherein the concentration of the purified collagenase in the pharmaceutically acceptable liquid carrier is between 0.58 mg/ml and 1.16 mg/ml.

10. The method of claim 2, wherein the volume of the pharmaceutically acceptable liquid carrier is between 0.1 ml and 2.0 ml.

11. The method of claim 2, wherein the liquid pharmaceutically acceptable carrier is selected from the group consisting of normal saline, aqueous NaCl/CaCl.sub.2 buffer, aqueous dextran solution, and aqueous hetastarch solution.

Details for Patent 10,071,143

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Smith And Nephew SANTYL collagenase OINTMENT;TOPICAL 101995 001 1965-06-04 ⤷  Free Forever Trial The Research Foundation for The State University of New York (Albany, NY) 2027-05-03 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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