Implant tension adjustment system and method

• US 9,125,717 B2
• Filed: 09/09/2011
• Issued: 09/08/2015
• Est. Priority Date: 02/23/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Alexander, James A.
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US13/229,460
• Publication Number:
  US 20120215058A1
• Time in Patent Office: 1,460 Days
• Field of Search: 600 29- 32, 600/37, 606151-153, 606/157
• US Class Current: 1/1
• CPC Class Codes: A61F 2/004 inflatable
• 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 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0013 for adjusting fluid pressure

Abstract

An implant or sling device is provided with a tension adjustment system. The adjustment system can include one or more small pressure bulbs placed against the inferior pubic rami for support. By palpating the bulbs (one on left and one on right), the pressure can be adjusted to control the tension of the implant. Other conduits, balloons, introduction tools, ports and fluid adjustment components and mechanisms can be included to provide selective adjustment of the tension of the implant relative to the supported tissue or organ.

Claims

1. An adjustable pelvic implant system, comprising:

an elongate implant implantable within a pelvic region of a patient, the implant having a support portion, and first and second extension portions each extending laterally from the support portion, with the first extension portion having a first tissue anchor and the second extension portion having a second tissue anchor such that a first extension length is defined from the support portion to the first tissue anchor and a second extension length is defined from the support portion to the second tissue anchor;

a first elongate fluid reservoir provided generally adjacent to and parallel with the first extension portion of the implant to selectively expand and increase tension by shortening a span of the first extension portion; and

a second elongate fluid reservoir provided generally adjacent to and parallel with the second extension portion of the implant to selectively expand and increase tension by shortening a span of the second extension portion.

2. The implant system of claim 1, further including a first flexible conduit in communication with the first elongate fluid reservoir.

3. The implant system of claim 1, further including a second flexible conduit in communication with the second elongate fluid reservoir.

4. The implant system of claim 1, wherein the first tissue anchor includes extending tines.

5. The implant system of claim 1, wherein the second tissue anchor includes extending tines.

6. The implant system of claim 1, wherein the support portion is adapted to support a urethra.

7. The implant system of claim 1, wherein the implant is an elongate porous mesh sling adapted to support a urethra to treat urinary incontinence.

8. An adjustable urethral sling system, comprising:

an elongate mesh sling including a support portion, and first and second extension portions each longer than and extending laterally from the support portion, the first and second extension portions each having distal tissue anchors, and a first extension length is defined from the support portion to the distal tissue anchor of the first extension portion and a second extension length is defined from the support portion to the distal tissue anchor of the second extension portion;

a tension adjustment mechanism having;

a first elongate inflatable fluid device provided generally parallel to and in longitudinal alignment with the first extension portion to selectively expand and thereby increase tension by shortening a length of the first extension portion; and

a second elongate inflatable fluid device provided generally parallel to and in longitudinal alignment with the second extension portion to selectively expand and thereby increase tension by shortening a length of the second extension portion.

9. The sling system of claim 8, wherein the distal tissue anchor of the first extension portion includes extending tines.

10. The sling system of claim 8, wherein the distal tissue anchor of the second extension portion includes extending tines.

11. The sling system of claim 8, wherein at least the support portion is construction of a porous mesh material.

12. The sling of claim 8, wherein the first and second extension portions are constructed of a porous mesh material.

13. The sling of claim 8, wherein the support portion is maintained in a generally flat orientation when the first elongate inflatable fluid device selectively shortens the length of the first extension portion.

14. The sling of claim 8, wherein the support portion is maintained in a generally flat orientation when the second elongate inflatable fluid device selectively shortens the length of the second extension portion.

15. The sling of claim 8, wherein at least the first extension portion includes a tapering portion and the first elongate inflatable fluid device extends adjacent and generally along the path of the tapering portion.