Pubovaginal sling device

• US 5,934,283 A
• Filed: 04/15/1997
• Issued: 08/10/1999
• Est. Priority Date: 04/15/1997
• Status: Expired due to Fees

• Current Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Original Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Inventors: Harris, Christopher, Hartjes-Doherty, Susan J., Willem, Germain E., Holman, Daniel G.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/839,777
• Time in Patent Office: 847 Days
• Field of Search: 600/30, 600/29, 604/358, 604/385.1, 604/55, 128/885, 606/151
• US Class Current: 128/885
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

A sling device for surgical implantation into human recipient to support the urethra, the sling including an elongated strip of supple material. The elongated strip has a center portion, opposite first and second side portions, and a slot passing through the center portion, through which one of the side portions can pass, thereby forming a loop in the elongated strip. The material is a biological acceptable material for implantation into the human recipient, preferably selected from the group consisting of synthetic polymers, processed animal tissues, and combination thereof. A method of reducing the incidence of involuntary urination or restoring urinary continence in an incontinent human subject is also disclosed, including the steps of providing a sling device of the type previously described and surgically implanting the sling device in the human subject so that the urethra is biased upward so as to elevate the urethra.

Claims

1. A sling device for surgical implantation in a human recipient to support the urethra, the sling device comprising:

an elongated strip of supple material which is biologically acceptable for implantation into the human recipient, the elongated strip of supple material having a looping limb and an extending limb extending from either side of a center portion, the center portion including a slot through which the looping limb can pass to thereby form a loop in the elongated strip of supple material for encircling the urethra to exert circumferential pressure on the urethra for the prevention of urinary incontinence.

2. The sling device of claim 1, wherein the material is selected from the group consisting of synthetic polymers, processed animal tissues, and combinations thereof, each of which are suitable for implantation in the human recipient.

3. The sling device of claim 2, wherein the material is a synthetic polymer selected from the group consisting of polytetrafluoroethylenes, expanded polytetrafluoroethylenes, polyethylene terephthalates and silicone elastomers.

4. The sling device of claim 2 wherein the material is a combination of a synthetic polymer and processed animal tissues, wherein the synthetic polymer is coated with animal tissue cells which are chemically cross-linked.

5. The sling device of claim 2 wherein the material is a processed animal tissue, the processed animal tissue being selected from the group consisting of porcine tissue, bovine tissue, ovine tissue, equine tissue and human tissue.

6. The sling device of claim 2, wherein the processed animal tissue is made from a tissue selected from the group consisting of tendons, ligaments and fibro serous tissues.

7. The sling device of claim 6, wherein the processed animal tissue is made from fibro serous tissues selected from the group consisting of dura mater, pericardium, peritoneum, tunica vaginalis and dermas.

8. The sling device of claim 2, wherein the processed tissues are tissues which have been cleansed, dehydrated, cross-linked and sterilized.

9. The sling device of claim 8, wherein the processed animal tissue is chemically cross-linked using a cross-linking agent selected from the group consisting of gutaradehyde, dialdehyde, dialdehyde starch and an epoxy compound.

10. The sling device of claim 1, wherein said looping limb and said extending limb each has an end portion spaced apart from a jointing portion which inter-connects said center portion with said looping limb and said extending limb, the sling device further comprising a first length of non-absorbable suture material which passes through said end portion of said looping limb distal to said center portion.

11. The sling device of claim 10, further comprising a suture needle with which the first length of suture material is engaged.

12. The sling device of claim 10, further comprising a second length of non-absorbable suture material passing through said end portion of said extending limb distal to said center portion.

13. The sling device of claim 12, further comprising a second needle through which the second length of non-absorbable suture material passes.

14. A sling device for surgical implantation in a human recipient to support the urethra, the sling device comprising:

an elongated strip of material having variable dimensions including a thickness, a width and a length;

wherein the length is greater than the width and the width is greater than the thickness;

the elongated strip having a center portion and opposite first and second side portions interconnected with and extending away from the center portion, the side portions including an extending limb and a looping limb, the looping limb having a smallest width which is less than a largest width of the center portion, the center portion including a slot through which the looping limb can pass, thereby forming a loop in the elongated strip which encircles and supports the urethra to prevent urinary incontinence;

wherein the material is a supple material which is sterile or can be effectively sterilized, and is otherwise biologically acceptable for implantation into the human recipient.

15. The sling device of claim 14, wherein the width of the looping limb is less than the width of the center portion.

16. The sling device of claim 15, wherein the slot has a width and length, the length of the slot being less than about 95% of the greatest width of the center portion and equal to or greater than the width of the looping limb.

17. The sling device of claim 16, wherein the elongated strip has shoulders extending from the looping limb to a point within the center portion where the width of the center portion is greater than the width of the looping limb, wherein the width of the center portion proximate at least one point proximate the shoulders is greater than the length of the slot.

18. The sling device of claim 14, wherein the material is selected from the group consisting of synthetic polymers, processed animal tissues, and combinations thereof, each of which are suitable for implantation in the human recipient.

19. The sling device of claim 18, wherein the material is a synthetic polymer selected from the group consisting of polytetrafluoroethylenes, expanded polytetrafluoroethylenes, polyethylene terephthalates and silicone elastomers.

20. The sling device of claim 18, wherein the material is a combination of a synthetic polymer and processed animal tissues, wherein the synthetic polymer is coated with animal tissue cells which are chemically cross-linked.

21. The sling device of claim 18, wherein the material is a treated animal tissue, the tissue being selected from the group consisting of porcine tissue, bovine tissue, ovine tissue, equine tissue and human tissue.

22. The sling device of claim 21, wherein the processed animal tissue is made from a tissue selected from the group consisting of tendons, ligaments and fibro serous tissues.

23. The sling device of claim 22, wherein the processed animal tissue is made from fibro serous tissues selected from the group consisting of dura mater, pericardium, peritoneum, tunica vaginalis and dermas.

24. The sling device of claim 21, wherein the processed tissues are tissues which have been cleansed, dehydrated, cross-linked and sterilized.

25. The sling device of claim 24, wherein the processed animal tissue is chemically cross-linked using a cross-linking agent selected from the group consisting of gutaraldehyde, glutaraldehyde starch, dialdehyde, dialdehyde starch and epoxy.

26. The sling device of claim 14, further comprising a first length of non-absorbable suture material, wherein the first length of suture material passes through a first end portion of the first side portion, distal to the center portion.

27. The sling device of claim 26, further comprising a suture needle with which the first length of suture material is engaged.

28. The sling device of claim 26, further comprising a second length of non-absorbable suture material passing through a second end portion of the opposite side portion.

29. The sling device of claim 28, further comprising a second needle through which the second length of non-absorbable suture material passes.

30. A method of reducing the incidence of involuntary urination in an incontinent human subject, wherein said incontinent human subject is a woman having a urethra, other tissues in general proximity to the urethra, and an abdominal rectus sheath, said method comprising the steps of:

(a) providing a sling device for surgical implantation into said incontinent human subject, said sling device including an elongated strip of supple material having a looping limb and an extending limb extending from a center portion, said center portion having a slot through which said looping limb can pass, said material being biologically acceptable for implantation into said incontinent human subject; and

(b) surgically implanting said sling device in said incontinent human subject such that said looping limb passes through said slot to form a loop which encircles said urethra, such that said looping limb and said extending limb encircle said other internal tissues, and such that said looping limb and said extending limb are fixed together to exert sufficient tension to restrain said loop such that said urethra is biased upward, closer to said other internal tissues within said incontinent human subject, when said incontinent human subject is in a standing position.

31. The method of claim 30, said step of surgically implanting including the further sub-steps of:

encircling said abdominal rectus sheath with said looping limb and said extending limb; and

fixing said looping limb and said extending limb together around at least a portion of said abdominal rectus sheath so as to provide sufficient tension to bias said urethra upward into an elevated position when said incontinent human subject is in said standing position.