Coated sling material

• US 20020072694A1
• Filed: 08/24/2001
• Published: 06/13/2002
• Est. Priority Date: 09/07/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Snitkin, Eva S., Cabak, James E., Westrum, John W. Jr.
• Granted Patent: US 7,025,063 B2
• Time in Patent Office: Days
• US Class Current: 602/4
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D10B 2509/08 Hernia repair mesh

Abstract

The present invention relates to a sling, methods of making and using a sling, and kits comprising a sling for treating urinary incontinence. The sling has multiple elongation properties that serve to improve the support of the urethra. The sling may comprise a coated material adapted for urethral suspension. The coated sling has properties that appear to enhance the sling elongation characteristics. The coated sling further includes properties that reduce its susceptibility to bacterial infections. The sling further includes properties to enhance the proper tensioning of the sling.

Claims

1. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said material has a first elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis.

said first and second elongation property being different from each other.

2. The sling as set forth in claim 1, wherein said second elongation property is greater than said first elongation property.

3. The sling as set forth in claim 1, wherein said first elongation property is approximately 8% elongation beyond a normal state of said sling material when said sling material is subjected to a tension of approximately 5 lbs.

4. The sling as set forth in claim 3, wherein said second elongation property is approximately 36% elongation beyond a normal state of said sling material when said sling material is subjected to a tension of approximately 5 lbs.

5. The sling as set forth in claim 1, wherein said first elongation property is in the range of approximately 24%-28% elongation beyond a normal state of said sling material when said sling is subjected to a tension of approximately 20 lbs.

6. The sling as set forth in claim 5 wherein said second elongation property is in the range of approximately 65%-75% elongation beyond a normal state of said sling material when said sling is subjected to a tension of approximately 20 lbs.

7. The sling as set forth in claim 1, wherein said sling is coated with a substance that enhances biocompatibility.

8. The sling as set forth in claim 7, wherein said material comprises a surgical mesh material.

9. The sling as set forth in claim 8, wherein said substance is silicone.

10. The sling as set forth in claim 9, wherein said coated mesh has a thickness within the range of approximately 0.024″

(0.61 mm) to 0.036″

(0.914 mm).

11. The sling as set forth in claim 7, wherein said material is impregnated with therapeutic agent.

12. The sling as set forth in claim 7, wherein said first elongation property is in the range of approximately 19.5-21.5% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 20 lbs.

13. The sling as set forth in claim 12 wherein said second elongation property is in the range of approximately 120-130% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 20 lbs.

14. The sling as set forth in claim 7, wherein said first elongation property is approximately 2.5% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 5 lbs.

15. The sling as set forth in claim 7, wherein said second elongation property is approximately 65% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 5 lbs.

16. The sling as set forth in claim 7, wherein said first elongation property is approximately 10.5% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 5 lbs.

17. The sling as set forth in claim 7, wherein said second elongation property is approximately 25% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 5 lbs.

19. A method as set forth in claim 18, wherein said coating is performed using a silicone dispersion.

20. A method as set forth in claim 18, wherein said mesh material is held in pre-tension in a longitudinal direction during said coating.

21. A method as set forth in claim 18, wherein said mesh material is held in pre-tension in a latitudinal direction during said coating.

22. A method as set forth in claim 18, wherein said manipulating of said mesh includes holding said mesh in pre-tension.

23. A method according to claim 18, wherein the step of coating said mesh material includes the step of continuously coating an elongate strip of said material.

24. A method according to claim 18 further including the step of blowing fluid such as air on the coated mesh material.

25. A method according to claim 24 wherein the step of blowing air includes the step of using pulsed air.

27. A sling as set forth in claim 26, wherein said sling material has a coated central region having an increased longitudinal elongation property and a somewhat decreased latitudinal elongation property as compared to elongation properties of said central region in a normal state.

28. A sling as set forth in claim 27, wherein said sling material has a coated intermediate region on either side of said central region, each of said intermediate regions having a decreased longitudinal elongation property and an increased latitudinal elongation property as compared to elongation properties of each of said intermediate regions in a normal state.

29. A sling as set forth in claim 28, wherein said sling material has a coated end region adjacent each intermediate region, each of said end regions having a decreased longitudinal elongation property and an increased latitudinal elongation property as compared to elongation properties of each of said end regions in a normal state.

18. A method of making a sling for treating urinary incontinence comprising:

providing a mesh material suitable for constructing a sling for supporting a urethra, said mesh having a first elongation property in a longitudinal direction and a second, different, elongation property in a latitudinal direction;

providing a coating dispersion;

coating said mesh material with said coating dispersion; and

manipulating said mesh material during said coating so as to create a predetermined value for said first and second elongation properties in said mesh material.

26. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said sling comprises a plurality of regions along its longitudinal axis and wherein each region contains differing elongation properties from an immediately adjacent region.

30. A method of restoring urethral anatomy in a patient suffering from urinary incontinence comprising the steps of:

providing a silicone coated sling,

inserting a silicone coated sling into the patient'"'"'s pelvic cavity;

manipulating said sling so as to pass under a central region of the patient'"'"'s urethra;

attaching each end portion of the sling to a posterior/inferior region of a right and a left pubic bone of the patient; and

positioning the sling so as to restore and stabilize the urethra to a position that maintains urinary continence by orienting said sling such that said sling has a first elasticity in a direction spanning across the urethra and a second, different elasticity in a direction along the axis of said urethra.

31. A method according to claim 30 wherein the step of providing the silicone coated sling includes the step of providing a sling wherein the first elasticity is more than the second elasticity.

32. A method according to claim 30 wherein the step of providing the silicone coated sling includes the step of providing a sling wherein the first elasticity is less than the second elasticity.

33. A method of placing a sling in a patient for the treatment of urinary incontinence comprising:

inserting a sling into the patient'"'"'s pelvic cavity, the sling having indicia capable or indicating tension in the sling;

manipulating said sling such that it passes underneath a central region of the patient'"'"'s urethra;

tensioning said sling until said sling achieves a predetermined tension as indicated by visual indicia present on said sling; and

,

securing said sling within said patient.

34. A method according to claim 33, wherein tensioning said sling includes observing visual indicia in the form of a predetermined width reduction in said sling.

35. A method according to claim 33, wherein tensioning said sling includes observing visual indicia having the form of a geometric pattern.

36. A method according to claim 33, wherein tensioning the sling includes observing a geometric pattern having the form of a distortion in a hole pattern of the sling material.

37. A method according to claim 33, wherein tensioning the sling includes observing a geometric pattern in the form of a distorted shape integrated onto the sling.

38. A method according to claim 33, wherein tensioning said sling includes observing visual indicia in the form of words.

40. A sling according to claim 39, wherein said visual indicia is a predetermined width of said sling.

41. A sling according to claim 39, wherein said visual indicia is a predetermined geometrical pattern of said sling.

42. A sling according to claim 41, wherein said predetermined geometrical pattern is a hole pattern in said mesh.

43. A sling according to claim 41, wherein said predetermined geometrical pattern is a geometrical shape integrated onto said mesh.

44. A sling according to claim 39, wherein said visual indicia is a word present on said sling.

39. A sling suitable for use in a sling procedure to treat urinary incontinence comprising:

a mesh material having a predetermined length and a width;

said mesh material having predetermined elongation properties;

said mesh having a predetermined visual indicia present on said mesh corresponding to the presence of a predetermined tension in said sling, said predetermined visual indicia being absent from said mesh when said sling is free from tension.