Method for treating gastrointestinal muscle disorders and other smooth muscle dysfunction

• US 5,437,291 A
• Filed: 08/26/1993
• Issued: 08/01/1995
• Est. Priority Date: 08/26/1993
• Status: Expired due to Term

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Johns Hopkins University
• Inventors: Kalloo, Anthony N., Pasricha, Pankai J.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/112,088
• Time in Patent Office: 705 Days
• Field of Search: 128/898, 128/DIG. 25, 604/19, 604/49, 514/906, 424/78.01
• US Class Current: 128/898
• CPC Class Codes: A61K 38/4893 Botulinum neurotoxin (3.4.24.69)
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence

Abstract

Direct injection of sphincteric botulinum toxin is disclosed as an effective, safe and simple method of treatment for disorders of gastrointestinal muscle or smooth muscles elsewhere in the body, with results that appear to be sustained for several months. Muscle disorders which are suitable for such treatment include achalasia, isolated disorders of the lower esophageal sphincter, gastroparesis, hypertrophic pyloric stenosis, sphincter of Oddi dysfunction, short-segment Hirschsprung'"'"'s, anal fissure, hemorrhoids, proctalgia fugax, irritable bowel syndrome, disorders of the upper esophageal sphincter, vasospastic disorders, and disorders of uterine and bladder spasm. Devices suitable for delivering this therapy are also disclosed.

Claims

1. A method for in vivo treatment of smooth muscle disorders of a mammal, comprising:

injecting directly into a smooth muscle in a mammal an amount of a neurotoxin which inhibits neurotransmitter release from nerve terminals.

2. The method for claim 1 wherein said amount of neurotoxin is sufficient to reduce spasm or tone of said smooth muscle.

3. The method of claim 1 wherein said neurotoxin inhibits acetylcholine release from nerve terminals.

4. The method of claim 1 wherein the muscle is in the mammal'"'"'s gastrointestinal tract.

5. The method of claim 1 wherein the muscle is in the mammal'"'"'s uterus.

6. The method of claim 1 wherein the muscle is in the mammal'"'"'s blood vessels.

18. The method of claim 1 or 7 wherein the neurotoxin is injected via a needle which is passed through an endoscope.

19. The method of claim 1 or 7 wherein the neurotoxin is selected from the group consisting of botulinum toxin, tetanus toxin, and tetrodotoxin.

20. The method of claim 1 or 7 wherein the neurotoxin is botulinum toxin.

21. The method of claim 1 or 7 wherein the neurotoxin is botulinum toxin type A.

22. The method of claim 1 or 7 wherein the effective amount consists of between about 0.1 and 1000 units of neurotoxin.

23. The method of claim 1 or 7 wherein the effective amount consists of between about 0.1 and 100 units of neurotoxin.

24. The method of claim 1 or 7 wherein the effective amount consists of between about 10 and 100 units of neurotoxin.

7. A method for in vivo treatment of disorders of a gastrointestinal muscle in the enteric nervous system of a mammal, comprising:

injecting directly into a tissue of enteric nervous system in a mammal an amount of a neurotoxin which inhibits neurotransmitter release from nerve terminals.

8. The method of claim 7 wherein said amount of said neurotoxin is sufficient to reduce spasm or tone of said gastrointestinal muscle in the enteric nervous system.

9. The method of claim 7 wherein said amount of said neurotoxin is sufficient to alleviate symptoms of said disorders of a gastrointestinal muscle in the enteric nervous system of a mammal.

10. The method of claim 7 wherein said neurotransmitter is acetylcholine.

11. The method of claim 7 wherein said gastrointestinal muscle in the enteric nervous system is a smooth muscle.

12. The method of claim 7 wherein said gastrointestinal muscle in the enteric nervous system is a skeletal muscle.

13. The method of claim 12 wherein the muscle is the cricopharyngeus.

14. The method of claim 11 wherein the muscle is the pylorus.

15. The method of claim 11 wherein the muscle is the lower esophageal sphincter.

16. The method of claim 11 wherein the muscle is the sphincter of Oddi.

17. The method of claim 11 wherein the muscle is the internal anal sphincter.