IP Library Granted Patent US 10,071,143
Granted Patent B1
US 10,071,143 · App. 14/988,205 · Granted Sep 11, 2018

Methods for non-surgical treatment of carpal tunnel syndrome

Inventors: Marie A. Badalamente (Mount Sinai, NY); Edward Wang (Poquott, NY)
Assignee: The Research Foundation for The State University of New York
A61K38/4886A61K9/0019A61K35/74C12Y304/24003
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Quick Facts
Patent No.
US 10,071,143
App. No.
14/988,205
Granted
Sep 11, 2018
Kind
B1
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.

Claims (12)

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 2 buffer, aqueous dextran solution, and aqueous hetastarch solution.

Assignments (2)
CONFIRMATORY LICENSE Recorded Dec 11, 2017
From: STATE UNIVERSITY NEW YORK STONY BROOK
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 044827/0203 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 28, 2016
From: BADALAMENTE, MARIE A.; WANG, EDWARD
To: THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK
Reel/Frame 039026/0589 →
Continuity (10)
Continuation In Part 14170039 · Jan 31, 2014
Continuation In Part 13688387 · Nov 29, 2012
Continuation 12266090 · Nov 6, 2008
Continuation In Part 12730688 · Mar 24, 2010
Continuation In Part 12722337 · Mar 11, 2010
Continuation In Part 12266090 · Nov 6, 2008
Continuation In Part 12115256 · May 5, 2008
Continuation In Part 14988205
Continuation In Part 12722337 · Mar 11, 2010
Provisional Application 60927437 · May 3, 2007