Claims for Patent: 9,108,005

Summary for Patent: 9,108,005

Title:	Treatment of carpal tunnel syndrome by injection of the flexor retinaculum
Abstract:	An apparatus and method for identifying the flexor retinaculum of the carpal tunnel, injecting an effective amount of an agent into at least a portion of flexor retinaculum or tissue adjacent thereto, wherein the agent is configured to weaken the flexor retinaculum. The system may further include means for increasing the tensile stress in the flexor retinaculum post-injection using hand exercises, thereby weakening its structural integrity and decreasing the pressure within the carpal tunnel that impairs median nerve function.
Inventor(s):	Agee; John M. (Cameron Park, CA), Goss; Ben C. (Athens, GA), King; Francis C. (Sacramento, CA), Woodhouse; Jeffrey (Sacramento, CA)
Assignee:	JOHN M. AGEE AND KAREN K. AGEE, TRUSTEES OF THE JOHN M. AGEE TRUST (Sacramento, CA)
Application Number:	14/153,785
Patent Claims:	1. A method for treating a patient with carpal tunnel syndrome, comprising: providing a needle guide comprising a guide hole configured for receiving an injection needle; wherein a clamp is coupled to the needle guide; the clamp being configured to house an imaging device; positioning a reference surface of the clamp at a palm of the patient's hand; slideably adjusting the needle guide with respect to the reference surface of the clamp; wherein an imaging surface of the imaging device is substantially parallel to a longitudinal axis of the guide hole of the needle guide; imaging the flexor retinaculum with respect to surrounding tissue during injection with the imaging device; inserting said injection needle to a tissue region associated with the flexor retinaculum of the patient; and injecting an agent into said location of the flexor retinaculum in one or more doses sufficient to weaken the structural integrity of the flexor retinaculum. 2. A method as recited in claim 1, wherein the agent further comprises one or more doses of collagenase or a corticosteroid. 3. A method as recited in claim 1, wherein the flexor retinaculum includes the transverse carpal ligament. 4. A method as recited in claim 1, wherein the flexor retinaculum includes its attachment to the bones. 5. A method as recited in claim 1, wherein imaging the flexor retinaculum comprises generating an ultrasound image. 6. A method as recited in claim 1, further comprising: increasing the tensile stress in the flexor retinaculum subsequent to injecting said agent. 7. A method as recited in claim 6, wherein the increase in tensile stress is generated by pressure within the carpal tunnel, said pressure generated by one or more of the following: having the patient use one or more digits of the hand, having the patient grip the hand around an object; flexing one or more fingers into the palm of the hand and having the patient pinch a thumb and one or more fingers of the hand together. 8. A method as recited in claim 7, wherein the object comprises a dynamometer. 9. A method as recited in claim 7, wherein the object is pressed into the palm or heel of the patient's hand. 10. A method as recited in claim 1, further comprising: measuring pressure within the carpal tunnel. 11. A method as recited in claim 1, further comprising: cutting the flexor retinaculum with a blade. 12. A method as recited in claim 1, further comprising: identifying a suitable treatment location of the patient's flexor retinaculum by computing the palmer-to-dorsal depth from the palm of the hand to the flexor retinaculum; and wherein the agent is injected via a needle at said computed palmer-to-dorsal depth along an axis substantially parallel to a longitudinal axis of the flexor retinaculum. 13. A method as recited in claim 1, wherein the agent is delivered at a central portion of the flexor retinaculum. 14. A method as recited in claim 1, further comprising: orienting the imaging device with respect to the clamp to obtain transverse and longitudinal images of the flexor retinaculum. 15. A method as recited in claim 1, further comprising: adjusting the needle guide in a palmar-dorsal direction while the longitudinal axis of the guide hole remains substantially parallel to the imaging surface. 16. A method for treating a patient with carpal tunnel syndrome, comprising: providing a needle guide comprising a guide hole configured for receiving an injection needle; wherein a clamp is coupled to the needle guide; the clamp being configured to house an imaging device; slideably adjusting the needle guide with respect to a reference surface of the clamp; wherein a linkage is attached to the clamp; wherein the linkage comprises a first joint that allows rotation of the clamp with respect to the hand; wherein the clamp is configured to rotate about the first joint in a palmar-dorsal direction with respect to the patient's hand to couple a reference surface of the clamp to a palm of the patient's hand; inserting said injection needle to a tissue region associated with the flexor retinaculum of the patient; and injecting an agent into said location of the flexor retinaculum in one or more doses sufficient to weaken the structural integrity of the flexor retinaculum. 17. A method as recited in claim 16, the linkage further comprising a second joint oriented perpendicular to the first joint, the method further comprising: rotating the clamp about the second joint in a radial-ulnar direction with respect to the patient's hand. 18. A method as recited in claim 17, the linkage further comprising a third joint oriented perpendicular to the first joint and second joint, the method further comprising: rotating the clamp about the third joint in an internal-external direction with respect to the patient's hand. 19. A method as recited in claim 16, further comprising: translating the clamp proximal to distal at the linkage with respect to the patient's hand.

Details for Patent 9,108,005

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2029-03-25