Reusable intravaginal delivery device, system, and method

• US 9,155,873 B2
• Filed: 05/16/2012
• Issued: 10/13/2015
• Est. Priority Date: 05/17/2011
• Status: Expired due to Fees

• Current Assignee: Reprotect, Inc.
• Original Assignee: Reprotect, Inc.
• Inventors: Moench, Thomas R.
• Primary Examiner(s): Palenik, Jeffrey T
• Application Number:
  US13/473,075
• Publication Number:
  US 20120296315A1
• Time in Patent Office: 1,245 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61M 2210/1475 Vagina
• 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

Abstract

The present disclosure is directed to a system, device and methods for treating or preventing genital tract infection. The system includes a point-of-use recharge kit having a first reusable intravaginal delivery device (RIDD1) and a second reusable intravaginal delivery device (RIDD2), and a therapeutic agent. Each RIDD includes a permeable wall defining an enclosed interior reservoir. The reservoir is adapted to receive the therapeutic agent. The system enables the point-of-use loading and reloading at least one of the RIDDs with the therapeutic agent by the end user.

Claims

1. A point-of-use load intravaginal delivery system comprising:

a first reusable intravaginal delivery device (RIDD1) and a second reusable intravaginal delivery device (RIDD2), each RIDD comprising a permeable wall defining an enclosed interior reservoir, the reservoir adapted to receive a therapeutic agent; and

a point-of-use recharge kit comprising a therapeutic agent, the point-of-use recharge kit for point-of-use loading at least one of the RIDDs with the therapeutic agent.

2. The system of claim 1 wherein each RIDD is a diffusion-loaded RIDD.

3. The system of claim 1 wherein the permeable wall is composed of a material selected from the group consisting of a polyurethane and a silicone.

4. The system of claim 1 wherein the therapeutic agent is a lactic acid composition.

5. The system of claim 1 wherein the point-of-use recharge kit comprises a bulk amount of the therapeutic agent selected from the group consisting of a powder and a solution.

6. The system of claim 1 wherein the point-of-use recharge kit further comprises a member selected from the group consisting of a recharge vessel, a cleaning solution, a cleaning device, and combinations thereof.

7. The system of claim 6 wherein the RIDD1 is in a vagina and the RIDD2 is in operative communication with a component of the point-of-use recharge kit.

8. The system of claim 1 wherein the therapeutic agent is a lactic acid composition;

and each RIDD has an intravaginal lactic acid release rate from 1 mg/day to 10,000 mg/day for 1 to 30 days.

9. The system of claim 4 wherein the lactic acid composition is in RIDD1 and RIDD1 is located in a vagina.

10. The system of claim 9 wherein the point-of-use recharge kit comprises a recharge vessel;

and the recharge vessel contains RIDD2 immersed in an amount of the lactic acid composition.

11. A method for delivering a therapeutic agent to a vagina, the method comprising:

providing a point-of-use recharge kit comprising a first reusable intravaginal delivery device (RIDD1), a second RIDD (RIDD2) and a therapeutic agent, each RIDD comprising a permeable wall defining an enclosed interior reservoir, each RIDD adapted to receive the therapeutic agent; and

enabling, with the kit, point-of-use loading of the therapeutic agent to at least one RIDD.

12. The method of claim 11 comprising inserting RIDD1 in the vagina;

delivering a therapeutically effective amount of the therapeutic agent to the vagina with RIDD1; and

point-of-use loading RIDD2 with the therapeutic agent.

13. The method of claim 12 comprising removing the RIDD1 from the vagina;

inserting the RIDD2 into the vagina; and

further delivering, with point-of-use loaded RIDD2, a therapeutically effective amount of the therapeutic agent into the vagina.

14. A method for delivering a therapeutic agent to a vagina, the method comprising:

point-of-use loading a first reusable intravaginal delivery device (RIDD1) with a therapeutic agent;

inserting the loaded RIDD1 into the vagina;

point-of-use loading a second RIDD (RIDD2) with the therapeutic agent;

replacing RIDD1 with RIDD2 in the vagina.

15. The method of claim 14 comprising delivering, with RIDD1, a therapeutically effective amount of the therapeutic agent to the vagina.

16. The method of claim 14 comprising delivering, with RIDD2, a therapeutically effective amount of the therapeutic agent to the vagina.

17. The method of claim 14 comprising point-of-use loading RIDD1 and RIDD2 with a lactic acid composition.

18. The method of claim 14 comprising removing RIDD1 from the vagina and point-of-use reloading RIDD1 with the therapeutic agent.

19. The method of claim 18 comprising replacing RIDD2 with the reloaded RIDD1 in the vagina.

20. The method of claim 19 comprising delivering, with the reloaded RIDD1, a therapeutically effective amount of the therapeutic agent to the vagina.