RESILIENT DEVICE

• US 20080033230A1
• Filed: 07/11/2007
• Published: 02/07/2008
• Est. Priority Date: 07/10/2006
• Status: Active Grant

• Current Assignee: First Quality Hygienic Incorporated (First Quality Enterprises LLC)
• Original Assignee: First Quality Hygienic Incorporated (First Quality Enterprises LLC)
• Inventors: Luehrs, Kirsten, Hou, Mari, Bartning, Michelle, Mavinkurve, Pramod, Rosenfeld, Leonard, Chase, David, Gironda, Kevin, Luchino, Thomas, Hull, Raymond
• Granted Patent: US 9,173,768 B2
• Time in Patent Office: Days
• US Class Current: 600/29
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina
• 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
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An intravaginal device has a working portion (e.g., intravaginal urinary incontinence device suppository, tampon) and an anchoring portion comprising at least one member extending beyond at least one end of the working portion to maintain the working portion in place during use.

Claims

1. An intravaginal urinary incontinence device comprising:

a) a working portion having opposed working surfaces to provide support to an associated urinary system; and

b) an anchoring portion to maintain the stent in place during use,

wherein the anchoring portion has at least one member extending beyond at least one end of the working portion capable of engaging vaginal walls.

2. The device according to claim 1, wherein the working portion comprises an elastic element.

3. The device according to claim 1, wherein the anchoring portion comprises an elastic element.

4. The device according to claim 1, wherein the working portion comprises a structure selected from the group consisting of a slotted tube, a wire form, and combinations thereof.

5. The device according to claim 4, wherein the wire form comprises a plurality of struts that at least partially define and support opposed working surfaces.

6. The device according to claim 5, wherein the working portion further comprises a withdrawal string, a proximal end of which is operatively connected to at least two struts and is arranged and configured such that tension on a distal end of the withdrawal string urges the opposed working surfaces together.

7. The device according to claim 2, wherein the elastic working portion comprises a material selected from the group consisting of polymers, metals, and combinations thereof.

8. The device according to claim 7, wherein the elastic working portion comprises a material selected from the group consisting of a shape memory polymer, a metal alloy, and combinations thereof.

9. The device according to claim 8 wherein the metal alloy is a nickel-titanium alloy.

10. The device according to claim 1 wherein the anchoring portion is arranged and configured to engage walls of the user'"'"'s vaginal formices.

11. The device according to claim 1 wherein the anchoring portion comprises at least two extensions beyond the at least one end of the working portion.

12. The device according to claim 1 wherein the anchoring portion comprises a shape selected from the group consisting of a basket handle, a dog bone, a rabbit ear, and combinations thereof.

13. An intravaginal urinary incontinence device comprising:

a) an elastic working portion having opposed working surfaces to provide support to an associated urinary system; and

b) means for anchoring the working portion at a desired location within a user'"'"'s vagina operatively connected to the working portion,

wherein the means for anchoring comprises at least one member extending beyond at least one end of the working portion that is capable of engaging the user'"'"'s vaginal walls.

14. The device according to claim 13 wherein the working portion comprises a structure selected from the group consisting of a slotted tube, a wire form, and combinations thereof.

15. The device according to claim 14 wherein the wire form comprises a plurality of struts that at least partially define and support opposed working surfaces.

16. The device according to claim 15 wherein the working portion further comprises means to collapse the working portion.

17. The device according to claim 16, wherein the means to collapse the working portion comprises a withdrawal string, a proximal end of which is operatively connected to at least two struts and is arranged and configured such that tension on a distal end of the withdrawal string urges the opposed working surfaces together

18. The device according to claim 13, wherein the elastic working portion comprises a material selected from the group consisting of polymers, metals, and combinations thereof.

19. The device according to claim 18, wherein the elastic working portion comprises a material selected from the group consisting of a shape memory polymer, a metal alloy, and combinations thereof.

20. The device according to claim 13, wherein the means for anchoring is arranged and configured to engage walls of the user'"'"'s vaginal formices.

21. The device according to claim 13, wherein the means for anchoring comprises at least two extensions beyond the at least one end of the working portion.

22. The device according to claim 13, wherein the means for anchoring comprises a shape selected from the group consisting of a basket handle, a dog bone, a rabbit ear, and combinations thereof.

23. An intravaginal device comprising:

a working portion comprising an elastic material formed into a wire form having a plurality of struts that at least partially define and support opposed working surfaces, which opposed working surfaces are capable of providing support to an associated urinary system; and

a withdrawal string, a proximal end of which is operatively connected to at least two struts and is arranged and configured such that tension on a distal end of the withdrawal string urges the opposed working surfaces together.

24. The device according to claim 23 further comprising an anchoring portion comprising at least one member extending beyond at least one end of the working portion to maintain the working portion in place during use.

25. An intravaginal device comprising a working portion and an anchoring portion comprising at least one member extending beyond at least one end of the working portion to maintain the working portion in place during use.

26. The device according to claim 25 wherein the working portion is selected from the group consisting of a suppository, a vaginal tampon, a bladder support, and a combination thereof.

27. The device according to claim 25 wherein the anchoring portion is designed and configured to engage walls of the user'"'"'s vaginal formices.

28. The device according to claim 25 wherein the anchoring portion comprises a wire form.

29. The device according to claim 25 wherein the anchoring portion comprises at least two extensions beyond an end of the working portion.

30. The device according to claim 25 wherein the anchoring portion comprises a shape selected from the group consisting of a basket handle, a dog bone, a rabbit ear, and combinations thereof.

31. An intravaginal urinary incontinence device comprising an elastic working portion having an insertion equivalent diameter ranging from about 10 to about 20 mm, wherein the working portion is capable of enlarging to provide a use equivalent diameter ranging from about 20 to about 35 mm under an expansion pressure of about 20 to about 150 cm H₂O.

33. The incontinence device of claim 31, wherein the working portion has a third use equivalent diameter of about 10 to about 20 under expansion pressure of 150 cm H₂O.

34. The incontinence device of claim 31, wherein the first use equivalent diameter is at least about 20 mm under an expansion pressure of 35 cm H₂O and a second use equivalent diameter is at least about 10 mm under an expansion pressure of 140 cm H₂O.

35. The incontinence device of claim 31, wherein the working portion comprises a structure selected from the group consisting of a slotted tube, a wire form, and combinations thereof.

36. The incontinence device of claim 31, wherein the wire form comprises a plurality of struts that at least partially define and support opposed working surfaces.

37. The incontinence device of claim 31, wherein the elastic working portion comprises a material selected from the group consisting of polymers, metals, and combinations thereof.

38. The incontinence device of claim 31, wherein the anchoring portion is arranged and configured to engage walls of the user'"'"'s vaginal formices.

39. The incontinence device of claim 31, wherein the anchoring portion comprises at least two extensions beyond the at least one end of the working portion.

40. The incontinence device of claim 31, wherein the anchoring portion comprises a shape selected from the group consisting of a basket handle, a dog bone, a rabbit ear, and combinations thereof.

32. An intravaginal urinary incontinence device comprising an elastic working portion having a first use equivalent diameter of at least about 15 mm under an expansion pressure of 20 cm H₂O and a second use equivalent diameter of about 5 to about 25 mm under an expansion pressure of 100 cm H₂O wherein the second use equivalent diameter is less than the first use equivalent diameter.

41. An intravaginal urinary incontinence device comprising

a) an elastic working portion having a first use equivalent diameter of at least about 15 mm under an expansion pressure of 20 cm H₂O and a second use equivalent diameter of about 5 to about 25 mm under an expansion pressure of 100 cm H₂O wherein the second use equivalent diameter is less than the first use equivalent diameter;

and

b) means for anchoring the working portion at a desired location within a user'"'"'s vagina operatively connected to the working portion.

42. An intravaginal urinary incontinence device comprising:

a) an elastic working portion comprising

i) opposed working surfaces to provide support to an associated urinary system; and

ii) a pad associated with each of the working surfaces; and

b) an anchoring portion operatively connected to the working portion to maintain the working portion at a desired location within a user'"'"'s vagina;

wherein the anchoring portion has at least one member extending beyond at least one end of the working portion capable of engaging vaginal walls.

43. The incontinence device of claim 42, wherein the working portion comprises a structure selected from the group consisting of a slotted tube, a wire form, and combinations thereof.

44. The incontinence device of claim 42, wherein the elastic working portion comprises a material selected from the group consisting of polymers, metals, and combinations thereof.

45. The incontinence device of claim 42, wherein the pad comprises a material selected from the group consisting of sponges and foams, thermoplastic elastomers, silicones, fibers, and combinations thereof.

46. A method of making an intravaginal stent comprising the steps of:

a) forming a working portion comprising an elastic material and having opposed working surfaces to provide support to an associated urinary system; and

b) forming an anchoring portion capable of maintaining the working portion in place during use.

50. The method of any of claims 46-48, further comprising the step of attaching a pad to each of the working surfaces.

51. The method of any of claims 46-48, wherein the working portion has a first use equivalent diameter of at least about 15 mm under an expansion pressure of 20 cm H₂O and a second use equivalent diameter of about 5 to about 25 mm under an expansion pressure of 100 cm H₂O wherein the second use equivalent diameter is less than the first use equivalent diameter.

47. A method of making an intravaginal stent comprising the steps of:

a) forming a working portion comprising a wire form having opposed working surfaces to provide support to an associated urinary system, wherein the wire form comprises an elastic material; and

b) forming an anchoring portion comprising a wire form operatively connected to and capable of maintaining the working portion in place during use.

49. The method of any of claims 47-48, further comprising the step of enclosing the wire form of each of the working portion and anchoring portion within a biocompatible material.

48. A method of making an intravaginal stent comprising the steps of:

a) forming a working portion comprising a wire form having opposed working surfaces to provide support to an associated urinary system, wherein the wire form comprises an elastic material;

b) forming an anchoring portion comprising a wire form operatively connected to and capable of maintaining the working portion in place during use;

c) attaching a withdrawal mechanism to the stent;

d) enclosing the stent within a sheet-like material; and

e) placing the enclosed stent in an applicator for delivery into the vagina.