Inflatable vaginal pessary

• US 5,603,685 A
• Filed: 05/05/1995
• Issued: 02/18/1997
• Est. Priority Date: 07/01/1994
• Status: Expired due to Fees

• Current Assignee: Donald F. Tutrone Jr
• Original Assignee: Donald F. Tutrone Jr
• Inventors: Tutrone, Donald F. Jr.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/434,362
• Time in Patent Office: 655 Days
• Field of Search: 128/830, 128/834, 128/836, 128/841, 128/885, 128/897, 128/898, 128/DIG. 25, 600/29-31, 623/11
• US Class Current: 600/29
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina

Abstract

A pessary device, comprising a first inflatable chamber adapted to fit in the vestibule of the vaginal cavity of a human when inflated, wherein the chamber compresses the urethra of the human when inflated; an anchor member adapted to snugly fit in the vaginal cavity, the anchor member being connected to the inflatable chamber on the posterior side of the chamber when the pessary is in its normal operating position; and an inflation tube having a first end fluidly connected to the inflatable chamber and a second end connected to an inflation valve located external to the vagina when the pessary device is in its normal operating position that permits inflation and deflation of the inflatable chamber without disturbing the fit of the anchor member.

Claims

1. A pessary device comprising:

(a) an inflatable, anterior chamber adapted to fit in a vestibule of a vaginal cavity of a human when inflated, wherein said inflatable anterior chamber compresses a urethra of the human when inflated,

(b) a first inflation tube having a first end fluidly connected to said inflatable, anterior chamber and a second end having a first inflation valve that permits inflation and deflation of said inflatable anterior chamber,

(c) an anchor member comprising an inflatable, posterior chamber adapted to snugly fit in a posterior region of the vaginal cavity when inflated, said inflatable posterior member being posteriorly connected to said inflatable anterior chamber when said pessary device is in its normal operating position, and

(d) a second inflation tube having a first end fluidly connected to said inflatable posterior chamber and a second end having a second inflation valve that permits inflation and deflation of said inflatable posterior chamber;

wherein inflation and deflation of said inflatable posterior and anterior chambers are separately controlled.

2. The pessary device of claim 1, wherein said inflatable anterior chamber has a fully inflated diameter less than or equal to a fully inflated diameter of said inflatable, posterior chamber.

3. The pessary device of claim 1, wherein said inflatable posterior chamber contains an expandable material.

4. The pessary device of claim 1, wherein said pessary comprises a central support member and said inflatable anterior and posterior chambers circumscribe and are contiguously attached to said central support member.

5. The pessary device of claim 4, wherein said support member forms an inflation channel comprising a support tube adapted to provide attachment sites for said inflatable anterior chamber and said inflatable posterior chamber;

said first inflation tube fluidly connected to said inflatable anterior chamber and adapted to fit inside said support tube; and

said second inflation tube fluidly connected to said inflatable posterior chamber and adapted to fit inside said support tube.

6. The pessary device of claim 4, wherein said support member comprises a tube having two separate channels molded together, each of said channels separately and fluidly connected to one or another of said inflatable anterior and posterior chambers.

7. The device of claim 1, wherein said first and second inflation valves are Luer lock valves.

8. The pessary device of claim 1, wherein said first and second inflation valves have different tactile coding.

9. The pessary device of claim 1, wherein said pessary device has at least one drainage surface groove on said inflatable anterior chamber and said inflatable posterior chamber to allow for drainage of vaginal secretions on an external surface of said pessary device.

10. The pessary device of claim 1, wherein said first and second inflation valves each comprises a fluid-pump-compatible valve.

11. The pessary device of claim 10, wherein said fluid-pump-compatible valve is selected from the group consisting of a syringe valve, a one-way valve air pump valve, a compressed air canister valve, a fluid bladder valve and a piston pump valve.

12. The pessary device of claim 1, wherein said inflatable anterior and posterior chambers are made of an elastic material or a non-elastic, flexible material.

13. The pessary device of claim 12, wherein said inflatable anterior and posterior chambers are made of a material selected from the group consisting of silicone, latex, polyurethane, polyethylene and polytetrafluoroethylene-coated latex.

14. The pessary device of claim 12, wherein said inflatable anterior and posterior chambers are made of different materials.

15. A kit, comprising:

the pessary device of claim 1,

a fluid pump adapted to fit the inflation valve of said pessary device, and

a container adapted to contain said pessary device and said fluid pump.

16. The kit of claim 15 further comprising a biocompatible lubricant.

17. A method of treating incontinence in a female human with a urethra, comprising:

inserting the pessary device of claim 1 into a vagina of said human, inflating the posterior inflatable chamber sufficiently to fit in a posterior region of a vaginal cavity, and

inflating said inflatable anterior chamber of said pessary device sufficiently to compress the urethra of said human and prevent urine flow.

18. The method of claim 17, further comprising deflating said inflatable anterior chamber to allow said human to urinate and re-inflating said inflatable anterior chamber after urination.

19. A method of treating cystoceles, rectoceles, uterine prolapse or vaginal prolapse in a vagina of a human, comprising:

inserting a pessary of claim 1 into the vagina of said human, inflating the posterior inflatable chamber sufficiently to fit in a posterior region of a vaginal cavity, and

inflating the chamber of said pessary to prevent tissue intrusion into the vagina.