Method of delivering therapeutic agents to the urethra and an urethral suppository

• US 6,464,670 B1
• Filed: 11/10/1999
• Issued: 10/15/2002
• Est. Priority Date: 09/09/1998
• Status: Expired due to Term

• Current Assignee: Inura Medical AG
• Original Assignee: Biomed Innovations LLC
• Inventors: Mulholland, S. Grant
• Primary Examiner(s): RUHL, DENNIS WILLIAM
• Application Number:
  US09/438,563
• Time in Patent Office: 1,070 Days
• Field of Search: 604/11-12, 604/15, 604/904, 604/285-288, 424/DIG.15, 424/426, 424/428, 424/430, 424/431, 424/433, 424/436
• US Class Current: 604/288
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 31/007 Injectors for solid bodies, e.g. suppositories

Abstract

A urethral suppository having a shaft shaped for cooperating with the action of the periurethral musculature to retain the suppository within the urethra, and having a knob extending from an end of the shaft sized to prevent over insertion of the suppository. A method of delivering one or more therapeutic agents to the urethra and associated structures, the method involving insertion of the urethral suppository into the urethra.

Claims

1. A urethral suppository formed from meltable biocompatible material, said suppository comprising:

(a) a shaft having a first end and tapering toward a second end; and

(b) a knob extending from the second end of said shaft and sized to prevent insertion of said knob into the urethra,

wherein said suppository comprises at least one therapeutic agent.

2. The urethral suppository of claim 1 wherein said first end is convex.

3. The urethral suppository of claim 1 wherein said knob is ellipsoidal and has a major axis substantially perpendicular to a longitudinal axis of said shaft.

4. The urethral suppository of claim 1 wherein the therapeutic agent is selected from one or more of the group consisting of antibiotics, antimicrobials, antifungal agents, analgesics, anaesthetics, steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, mucous production stimulators, hormones, and anti-spasmodics.

5. The urethral suppository of claim 1 wherein the biocompatible material is a biocompatible carrier medium selected from one or more of the group consisting of modified celluloses, poly(vinyl alcohol), poly (vinylpyrrolidone), polyacrylamide, poly(ethylene glycol), poly (phosphoester urethanes), and ethylenoxide polymers.

6. The urethral suppository of claim 1 wherein the therapeutic agent is disposed throughout the biocompatible material.

7. The urethral suppository of claim 1 wherein the therapeutic agent is applied as a coating to the biocompatible material.

8. The urethral suppository of claim 1 wherein the therapeutic agent is applied differentially to the biocompatible material.

20. A method for delivering a therapeutic agent to one or more female structures selected from the group consisting of the urethra, bladder, and periurethral musculature, said method comprising the step of inserting the suppository of claim 1 into the urethra for a sufficient period of time for said therapeutic agent to diffuse from said suppository to said one or more female structures.

9. The urethral suppository for insertion in a female urethra having a luminal wall, said suppository formed from meltable bicompatible material, said suppository comprising:

(a) a shaft having a length situated between a first end and a second end; and

(b) an ellipsoidal knob laterally projecting from the second end of said shaft and sized to prevent insertion of said knob into the urethra,

wherein said suppository comprises at least one therapeutic agent.

10. A urethral suppository for insertion in a female urethra having a luminal wall, said suppository formed from meltable biocompatible material, said suppository comprising:

(a) a shaft having a length situated between a first end and a second end; and

(b) an ellipsoidal knob extending from the second end of said shaft and sized to prevent insertion of said knob into the urethra,

wherein said suppository comprises at least one therapeutic agent applied as a coating to the biocompatible material.

11. A urethral suppository for insertion in a female urethra having a luminal wall, said suppository formed from meltable biocompatible material, said suppository comprising:

(a) a shaft having a length situated between a first end and a second end; and

(b) an ellipsoidal knob extending from the second end of said shaft and sized to prevent insertion of said knob into the urethra,

wherein said suppository comprises at least one therapeutic agent applied differentially to the biocompatible material.

19. The urethral suppository of claim 11 wherein said first end is rounded.

12. A urethral suppository formed from meltable biocompatible material, said suppository comprising:

(a) a shaft having a blunt, rounded first end tapering toward a second end; and

(b) an ellipsoidal knob extending from the second end of said shaft and sized to prevent insertion of said knob into the urethra, wherein said shaft and knob comprise at least one therapeutic agent and a meltable biocompatible material.

13. The urethral suppository of claim 12 wherein the therapeutic agent is selected from one or more of the group consisting of antibiotics, anti-microbials, antifungal agents, analgesics, anaesthetics, steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, mucous production stimulators, hormones, and anti-spasmodics.

14. The urethral suppository of claim 12 wherein the biocompatible material is a biocompatible carrier medium selected from one or more of the group consisting of modified celluloses, poly(vinyl alcohol), poly (vinylpyrrolidone), polyacrylamide, poly(ethylene glycol), poly (phosphoesterOurethanes), and ethylenoxide polymers.

15. The urethral suppository of claim 12 wherein the therapeutic agent is disposed throughout the biocompatible carrier medium.

16. The urethral suppository of claim 12 wherein the therapeutic agent is applied as a coating to the biocompatible carrier medium.

17. The urethral suppository of claim 12 wherein the therapeutic agent is applied differentially to the biocompatible carrier medium.

18. The urethral suppository of claim 17 wherein said first end is blunt.

21. A method for delivering a therapeutic agent to one or more female structures selected from the group consisting of the urethra, bladder, and periurethral musculature, said method comprising the step of inserting the suppository of claim 12 into the urethra for a sufficient period of time for said therapeutic agent to diffuse from said suppository to said one or more female structures.