IP Library Granted Patent US 10,820,978
Granted Patent B2
US 10,820,978 · App. 15/489,211 · Granted Nov 3, 2020

Implants and methods for treatments of pelvic conditions

Inventors: Ram Kumar Balachandran (Maple Grove, MN); Thomas A. Albrecht (Edina, MN); John A. Bostrom (St. Paul, MN)
Assignee: Boston Scientific Scimed, Inc.
A61F2/0045A61F2220/0025A61F2230/006A61F2250/0008A61F2250/0018
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Quick Facts
Patent No.
US 10,820,978
App. No.
15/489,211
Granted
Nov 3, 2020
Kind
B2
Abstract

The present invention relates to surgical implants with adjustable size features, and methods for treating pelvic conditions by use of the implants.

Claims (45)

1. A Y-shaped surgical implant comprising:

a base comprising a fixed length of implant material extending between a distal base end and a proximal base end, the base defining a sacral leaf, a first vaginal leaf, and a width,

a moveable junction that is moveable along the length between the distal base end and the proximal base end,

wherein

the first vaginal leaf extends between the proximal base end and the moveable junction,

the sacral leaf extends between the moveable junction and the distal base end, and

a second vaginal leaf comprising implant material extends from the moveable junction, the second vaginal leaf has a second vaginal leaf length between a distal second vaginal leaf end at the moveable junction, and a loose proximal vaginal leaf end, and the second vaginal leaf length is adjustable by movement of the moveable junction along the length of the base.

2. An implant of claim 1 wherein the moveable junction is moveably attached to the base along a width of the base in a manner that allows the moveable junction to maintain engagement with the base while being moved along the length of the base.

3. An implant of claim 1 wherein the first vaginal leaf has a length between the first base end and the location of the moveable junction along the length of the base, and the length of the first vaginal leaf is adjustable by movement of the moveable junction along the length of the base.

4. An implant of claim 1 wherein the sacral leaf has a length between the base end and the location of the moveable junction along the length of the base, and the length of the sacral leaf is adjustable by movement of the movable junction along the length of the base.

5. An implant of claim 1 wherein the moveable junction includes a slider securely attached to the distal end of the second vaginal leaf the slider being moveably attached to the base along a width of the base in a manner that allows the slider to maintain engagement with the base while moving along the length of the base.

6. An implant of claim 1 wherein the moveable junction includes a frictional engagement that can be selectively placed in an open configuration or a closed configuration, wherein with the frictional engagement in the open configuration the moveable junction can be moved along the length of the base while maintaining engagement with the base, and with the frictional engagement in the closed configuration the frictional engagement frictionally prevents movement of moveable connection along the length of the base.

7. An implant of claim 6 wherein the moveable junction is selected from a spring-loaded frictional engagement that is biased open, and a spring-loaded frictional engagement that is biased closed.

8. An implant of claim 1 adapted to allow the first vaginal leaf and the second vaginal leaf to be secured to non-apical anterior and posterior vaginal tissue, while the sacral leaf extends to and is secured to tissue at a region of a sacrum.

9. A method of treating vaginal vault prolapse in a female patient, the method comprising:

providing a Y-shaped implant comprising an anterior vaginal leaf, a posterior vaginal leaf, and a sacral leaf, the three leafs being connected at a junction, the junction includes a frictional engagement that can be selectively placed in an open configuration or a closed configuration, at least one of the anterior vaginal leaf and the posterior vaginal leaf being an adjustable-length vaginal leaf wherein a length of the at least one anterior vaginal leaf and posterior vaginal leaf between the junction and a proximal end of the vaginal leaf is adjustable,

attaching the anterior vaginal leaf to anterior vaginal tissue of the patient,

attaching the posterior vaginal leaf to posterior vaginal tissue of the patient, and

adjusting the length of the at least one adjustable-length vaginal leaf to increase or to decrease the amount of tension applied by the implant to the anterior vaginal tissue, relative to the amount of tension applied by the implant to the posterior vaginal tissue.

10. A method of claim 9 further comprising, after attaching the anterior vaginal leaf to the anterior vaginal tissue and after attaching the posterior vaginal leaf to the posterior vaginal tissue, adjusting the length of the at least one adjustable-length vaginal leaf to increase or to decrease the amount of tension applied by the implant to the anterior vaginal tissue, relative to the amount of tension applied by the implant to the posterior vaginal tissue.

11. A method of claim 9 further comprising, after adjusting the length, attaching the sacral leaf to tissue at a region of sacral anatomy of the patient.

12. A method of claim 9 wherein

the method includes treating cystocele, and

the adjusting step includes placing a greater amount of tension on the non-apical anterior vaginal tissue compared to the amount of tension placed on the posterior vaginal tissue.

13. A method of claim 9 wherein

the method includes treating rectocele, and

the adjusting step includes placing a greater amount of tension on the non-apical posterior vaginal tissue compared to the amount of tension placed on the posterior vaginal tissue.

14. A method of claim 9 wherein the adjusting step includes adjusting the length of the at least one adjustable-length vaginal leaf such that a length of implant material between the junction and a first location of attachment of the anterior vaginal leaf to the anterior vaginal tissue is less than a length of implant material between the junction and a first location of attachment of the posterior vaginal leaf to the posterior vaginal tissue.

15. A method of claim 9 wherein the adjusting step includes adjusting the length of the at least one adjustable-length vaginal leaf such that a length of implant material between the junction and a first location of attachment of the anterior vaginal leaf to the anterior vaginal tissue is greater than a length of implant material between the junction and a first location of attachment of the posterior vaginal leaf to the posterior vaginal tissue.

16. A method of claim 9 wherein

the method includes treating rectocele, enterocele, or a combination thereof, and

the adjusting step includes placing a greater amount of tension on the posterior vaginal tissue compared to the amount of tension placed on the anterior vaginal tissue.

17. A method of claim 9 wherein the implant comprises

a base comprising a length of open pore implant material between a first end and a second end, the sacral leaf at the first end and the anterior vaginal leaf at the second end, and a width, and

the posterior vaginal leaf comprising a loose end, a proximal end, a length between the loose end and the proximal end, and a width,

wherein the second vaginal leaf meets the base to form the moveable junction that allows movement of a location of the junction along the length of the base.

18. A Y-shaped surgical implant comprising:

a base comprising a fixed length of implant material extending between a distal base end and a proximal base end, the base defining a sacral leaf, a first vaginal leaf, and a width,

a moveable junction that is moveable along the length between the distal base end and the proximal base end, the moveable junction includes a frictional engagement that can be selectively placed in an open configuration or a closed configuration,

wherein

the first vaginal leaf extends between the proximal base end and the moveable junction,

the sacral leaf extends between the moveable junction and the distal base end, and

a second vaginal leaf comprising implant material extends from the moveable junction.

19. The implant of claim 18 , wherein when the frictional engagement is in the open configuration the moveable junction can be moved along the length of the base while maintaining engagement with the base, and when the frictional engagement is in the closed configuration the frictional engagement frictionally prevents movement of the moveable junction along the length of the base.

20. An implant of claim 18 , wherein the frictional engagement is selected from a spring-loaded frictional engagement that is biased open, and a spring-loaded frictional engagement that is biased closed.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 7, 2017
From: ASTORA WOMEN'S HEALTH, LLC; ENDO HEALTH SOLUTIONS INC.; ASTORA WOMEN'S HEALTH HOLDINGS, LLC
To: BOSTON SCIENTIFIC CORPORATION
Reel/Frame 043777/0895 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 7, 2017
From: BOSTON SCIENTIFIC CORPORATION
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 043778/0167 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2017
From: ALBRECHT, THOMAS A.; BALACHANDRAN, RAM KUMAR; BOSTROM, JOHN A.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 042087/0739 →
Continuity (2)
Provisional Application 62325269 · Apr 20, 2016
Related Publication 20170304037A1 · Oct 26, 2017