Resilient intravaginal device

• US 10,004,584 B2
• Filed: 07/10/2006
• Issued: 06/26/2018
• Est. Priority Date: 07/10/2006
• Status: Expired due to Fees

• Current Assignee: First Quality Hygienic Incorporated (First Quality Enterprises LLC)
• Original Assignee: First Quality Hygienic Incorporated (First Quality Enterprises LLC)
• Inventors: Bartning, Michelle, Gironda, Kevin F., Hou, Mari, Luchino, Thomas P., Luehrs, Kirsten Freislinger, Mavinkurve, Pramod, Rosenfeld, Leonard, Hull, Jr., Raymond J., Chase, David J.
• Primary Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US11/456,390
• Publication Number:
  US 20080009931A1
• Time in Patent Office: 4,369 Days
• Field of Search: 600 29, 600 30
• CPC Class Codes: A61F 13/2082 Apparatus or processes of manufacturing
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 6/08 Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception , e.g. combined with devices protecting against contagion
• CPC Class Codes: A61F 6/12 Inserters or removers

Abstract

A device includes a somewhat cylindrical working portion having an initial equivalent diameter ranging from about 20 to about 170 mm, an insertion equivalent diameter ranging from about 5 to about 25 mm, a use equivalent diameter ranging from about 20 to about 40 mm and a length ranging from about 20 to about 60 mm; and an anchoring portion extending beyond the working portion and having an initial equivalent diameter ranging from about 20 to about 60 mm, an insertion equivalent diameter ranging from about 10 to about 25 mm, a use equivalent diameter ranging from about 20 to about 60 mm and a length ranging from about 10 to about 50 mm.

Claims

1. An intravaginal wire-form device for controlling urinary incontinence in a user comprising:

a) a working portion comprising elastic material struts and having an initial equivalent diameter ranging from 20 to 170 mm, an insertion equivalent diameter ranging from 5 to 25 mm, a use equivalent diameter ranging from 20 to 40 mm and a length suitable for insertion by a user into a vagina of the user ranging from 20 to 60 mm, the wire-form in the working portion comprising a sinusoidal shape;

b) an anchoring portion comprising an elastic material and for retention in the vagina, wherein the entire anchoring portion extends beyond the working portion and having an initial equivalent diameter ranging from 20 to 60 mm, an insertion equivalent diameter ranging from 10 to 25 mm, a use equivalent diameter ranging from 20 to 60 mm and a length ranging from 10 to 50 mm; and

c) a withdrawal element extending from the device to enable the user to make the device smaller for removal from the vagina of the user by pulling on the withdrawal element after use, wherein the withdrawal element comprises a string crisscrossed between struts of the device,

wherein the use equivalent diameter of the anchoring portion is larger than the use equivalent diameter of the working portion, the use equivalent diameter of the working portion is larger than the insertion equivalent diameter of the working portion, wherein the working portion has a different shape than the anchoring portion, the wire-form device further enclosed in a friction reducing material,

wherein wire-form is a single wire, wherein the working portion has a greater number of struts than the anchoring portion and wherein the anchoring portion is non-tubular in shape.

2. The device according to claim 1 wherein the working portion has an initial equivalent diameter of 20 to 45 mm, an insertion equivalent diameter of 10 to 20 mm, a use equivalent diameter of 25 to 30 mm and a length of 20 to 30 mm, and the anchoring portion has an initial equivalent diameter of 40 to 60 mm, an insertion equivalent diameter of 10 to 20 mm, a use equivalent diameter of 40 to 60 mm and a length of 20 to 40 mm.

3. The device according to claim 2 wherein the working portion has an initial equivalent diameter of 30 mm, an insertion equivalent diameter of 18 mm, a use equivalent diameter of 25 mm and a length of 25 mm, and the anchoring portion has an initial equivalent diameter of 50 mm, an insertion equivalent diameter of 18 mm, a use equivalent diameter of 50 mm and a length of 30 mm.

4. The device according to claim 1 wherein the elastic material is a shape memory polymer.

5. The device according to claim 1 wherein the elastic material is a metal alloy.

6. The device according to claim 5 wherein the metal alloy is a nickel-titanium alloy.

7. The device according to claim 1 wherein the working portion exerts a pressure of from 50 to 250 cm H₂O a use state.

8. The device according to claim 1 wherein the friction reducing material is a biocompatible material.

9. The device according to claim 8 wherein the biocompatible material comprises silicone.

10. The device according to claim 9 wherein the biocompatible material comprises a tubular silicone sheath.

11. The device according to claim 9 wherein the biocompatible material comprises a silicone coating.

12. The device of claim 1, wherein the working portion and anchoring portion are enclosed in a flexible bag.

13. The intravaginal device of claim 1, wherein the device is contained within a push-type applicator which comprises a collar to control depth of insertion into the vagina.