Expandable surgical implants and methods of using them

• US 6,666,817 B2
• Filed: 10/05/2001
• Issued: 12/23/2003
• Est. Priority Date: 10/05/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Li, Jianmin
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): Veniaminov, Nikita R
• Application Number:
  US09/972,377
• Publication Number:
  US 20030069469A1
• Time in Patent Office: 809 Days
• Field of Search: 600/30, 600/29, 600/37, 128/897, 128/898, 606/198, 606/151, 606/167, 606/196, 606/205-209, 623/13.11, 3/1
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Disclosed herein are expandable surgical implants that may be expanded one or more times by directly or indirectly uncinching one or more expansion loops. Use of the expandable surgical implant permits a physician to expand, with minimal invasion, a surgical implant that was over-tensioned by a surgeon during implantation or became over-tensioned due to changes in the patient'"'"'s anatomy.

Claims

1. An expandable surgical implant comprising a biocompatible material having a first end, a second end positioned opposite to the first end, and a central perpendicular axis located substantially equidistant from the first and second ends, and further comprising at least one expansion loop positioned lateral to the central perpendicular axis, the expandable surgical implant having a length perpendicular to the central perpendicular axis that increases with expansion of the at least one expansion loop.

2. The device of claim 1, comprising 2, 4, or 6 expansion loops positioned lateral to the central perpendicular axis.

3. The device of claim 1, wherein equal number of expansions loops are positioned on opposite sides of the central perpendicular axis.

4. The device of claim 1, wherein the expansion loop comprises at least one pair of control element attachment sites positioned on one side of the central perpendicular axis, and at least one control element associated with the attachment sites and drawing the attachment sites into close proximity.

5. The device of claim 4, wherein a first attachment site is positioned a distance ranging from 3 to 20 mm lateral to the central perpendicular axis.

6. The device of claim 5, wherein a second attachment site is positioned a distance ranging from 3 to 12 mm further from the central perpendicular axis than the first attachment site.

7. The device of claim 5, wherein the second attachment site is positioned a distance of about 5 mm further from the central perpendicular axis than the first control element.

8. The device of claim 4, wherein the control element comprises a fastener.

9. The device of claim 8, wherein the fastener is selected from the group consisting of a monofilament suture, a multifilament suture, an elongate length of biocompatible material, and a surgical staple.

10. The device of claim 8, wherein each of the attachment sites is reinforced with an eyelet.

11. The device of claim 8, wherein the control element attachment sites are reinforced with an additional layer of biocompatible sling material.

12. The device of claim 4, wherein the attachment sites are reinforced.

13. The device of claim 4, wherein the control element is radio-opaque.

14. The device of claim 4, wherein the control element is a different color than the biocompatible material.

15. The device of claim 1, wherein the length of biocompatible material comprises synthetic material.

16. The device of claim 15, wherein the synthetic material comprises at least one of the group consisting of nylon, polyethylene, polyester, polypropylene, fluoropolymer, and combinations thereof.

17. The device of claim 1, wherein the length of biocompatible material comprises natural material.

18. The device of claim 1, further comprising a visual indicator located along at least a portion of the central perpendicular axis.

19. The device of claim 18, wherein the visual indicator comprises a surgical dye applied along the central perpendicular axis.

20. The device of claim 18, wherein the visual indicator is a radio-opaque material woven into the biocompatible material along the central perpendicular axis.

21. The device of claim 1, wherein the length of biocompatible material is elongate in shape.

22. The device of claim 1, wherein the length of biocompatible material is substantially rectangular in shape.

23. The device of claim 1, wherein the length of biocompatible material is about 20 to 50 cm long with all expansion loops cinched material.

24. An expandable surgical implant comprising a biocompatible material having a first end, a second end positioned opposite to the first end, and a central perpendicular axis located substantially equidistant from the first and second ends, and further comprising at least one expansion loop positioned lateral to the central perpendicular axis, wherein the expansion loop comprises at least one pair of control element attachment sites positioned on one side of the central perpendicular axis and at least one control element comprising bioabsorbable material, the at least one control element being associated with the attachment sites and drawing the attachment sites into close proximity.

25. The device of claim 24, wherein the control element is adapted to decompose upon exposure to a localized low energy source.

26. The device of claim 25, wherein the localized low energy source emits energy in a form selected from the group consisting of ultrasonic waves, radio waves, microwaves, and ultraviolet radiation.

27. An expandable surgical implant comprising a biocompatible material having a first end, a second end positioned opposite to the first end, and a central perpendicular axis located substantially equidistant from the first and second ends, and further comprising at least one expansion loop positioned lateral to the central perpendicular axis, wherein the expansion loop comprises at least one pair of control element attachment sites positioned on one side of the central perpendicular axis and at least one control element adapted to decompose upon application of an external stimuli, the at least one control element being associated with the attachment sites and drawing the attachment sites into close proximity.

28. The device of claim 27, wherein the control element is adapted to decompose upon the application of a chemical agent.

29. The device of claim 27, comprising multiple expansion loops, wherein each of the control elements is adapted to decompose upon the application of different external stimuli.

30. An expandable surgical implant comprising a length of biocompatible material having a first end, a second end positioned opposite to the first end, and a central perpendicular axis located substantially equidistant from the first and second ends, and further comprising at least one expansion loop positioned lateral to the central perpendicular axis, wherein the expansion loop comprises multiple layers of biocompatible material of unequal length incorporated into the length of biocompatible material.

31. The device of claim 30, wherein the layers of biocompatible material are stacked in order of increasing length.

32. The device of claim 30, wherein a first layer of biocompatible material is about 2 mm to about 10 mm shorter than a second layer of biocompatible material.

33. The device of claim 32, wherein the first layer of biocompatible material is about 5 mm shorter than the second layer of biocompatible material.

34. The device of claim 30, wherein the layers of biocompatible material are positioned a distance ranging from 3 to 20 mm lateral to the central perpendicular axis.

35. An expandable surgical implant comprising a length of biocompatible material having a first end, a second end positioned opposite to the first end, and a central perpendicular axis located substantially equidistant from the first and second ends, and further comprising at least one expansion loop positioned lateral to the central perpendicular axis, wherein the length of the biocompatible material comprises a combination of natural and synthetic material.

36. The device of claim 35, further comprising a central portion positioned between a first lateral portion and a second lateral portion, wherein the central portion comprises natural material and the lateral portions comprise synthetic material.

37. A method of treating urinary incontinence comprising:

implanting an expandable surgical implant into a patient to thereby support the urethra, the expandable surgical implant comprising at least one expansion loop; and

expanding the implant post-operatively to reduce tension applied on the urethra.

38. The method of claim 37, wherein the implanting step comprises implanting the expandable surgical implant into a patient, the implant comprising a biocompatible material having a first end, a second end positioned opposite to the first end, and a central perpendicular axis located substantially equidistant from the first and second ends, and comprising at least one expansion loop positioned along the length and lateral to the central perpendicular axis.

39. The method of claim 38, further comprising the step of aligning a central portion of the implant beneath the urethra using a visual indicator located along at least a portion of the central perpendicular axis.

40. The method of claim 37, wherein the implanting step comprises implanting the expandable surgical implant beneath the bladder neck.

41. The method of claim 37, wherein the implanting step comprises implanting the expandable surgical implant beneath the central third of the urethra.

42. The method of claim 37, wherein the implanting step comprises affixing the implant to an anatomical structure selected from the group consisting of fascia, bone, ligament, and muscle.

43. A method of treating urinary incontinence comprising:

implanting an expandable surgical implant into a patient to thereby support the urethra, the expandable surgical implant comprising a central axis and at least one expansion loop; and

expanding the implant by uncinching a control element which holds in close proximity a pair of control element sites located on one side of the central axis to reduce tension applied on the urethra.

44. The method of claim 43, wherein the uncinching is accomplished by severing the control element.

45. The method of claim 44, wherein the control element comprises radio-opaque material and the control element is visualized using a fluoroscope prior to the severing.

46. The method of claim 44, wherein the uncinching is accomplished by applying an external stimulus to cause the control element to decompose.

47. The method of claim 46, wherein the external stimulus is emitted by a localized low energy source.

48. The method of claim 47, wherein the localized low energy source emits energy in a form selected from the group consisting of ultrasonic waves, radio waves, microwaves, and ultraviolet radiation.

49. The method of claim 46, further comprising the step of uncinching multiple expandable loops by the application of a combination of different external stimuli.

50. A method of treating urinary incontinence comprising:

implanting an expandable surgical implant into a patient to thereby support the urethra, the expandable surgical implant comprising a length of biocompatible material and at least one expansion loop; and

expanding the implant by severing the shorter of at least two layers of material of unequal length incorporated into the length of biocompatible material to reduce tension applied on the urethra.