IP Library Granted Patent US 10,335,256
Granted Patent B2
US 10,335,256 · App. 14/563,567 · Granted Jul 2, 2019

Surgical articles and methods for treating pelvic conditions

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Quick Facts
Patent No.
US 10,335,256
App. No.
14/563,567
Granted
Jul 2, 2019
Kind
B2
Abstract

Described are pelvic implants and methods of surgically placing pelvic implants, that provide treatment for pelvic floor disorders by support of the levator.

Claims (48)

1. A method of supporting a tissue of a pelvic floor, the method comprising:

creating an incision that allows access to a region of the pelvic floor;

providing a pelvic implant including a tissue support portion, a first extension portion, and a second extension portion, the tissue support portion including a first side end and a second side end opposite the first side end, the first side end having a first length and the second side end having a second length, the second length being different than the first length, the first extension portion and the second extension portion being integrally formed with the tissue support portion, a first anchor disposed at the first extension portion and a second anchor disposed at the second extension portion, a third length between the first extension portion and the second extension portion defining a third side end, the third side end being at an angle with respect to at least one of the first side end or the second side end, the pelvic implant having a width at a medial portion of the tissue support portion, the third length being larger than the width;

adjusting a length of the first extension portion to allow a distal end of the first anchor to reach a desired tissue within or external to the pelvic floor;

passing the pelvic implant through the incision and placing the tissue support portion at the tissue of the pelvic floor; and

positioning the tissue support portion at the region of the pelvic floor to support the tissue of the pelvic floor.

2. The method of claim 1 comprising placing the tissue support portion inferior to a superficial transverse perineal muscle.

3. The method of claim 1 , wherein the method is selected from the group consisting of:

a method of treating fecal incontinence,

a method of supporting a perineal body,

a method of perineal body repair,

a method of treating levator avulsion,

a method of treating levator ballooning,

a method of supporting levator ani muscle,

a method of levator ani muscle repair,

a method of tightening or reducing the size of a levator hiatus,

a method of treating vaginal prolapse, and combinations of one or more of these.

4. The method according to claim 1 , wherein the pelvic implant further comprises an extension portion extending from the tissue support portion, and the method comprises extending the extension portion to contact the tissue of the pelvic region to support levator tissue.

5. The method according to claim 1 , further comprising securing the first anchor to an obturator internus muscle.

6. The method according to claim 1 , further comprising securing the pelvic implant to the tissue selected from: sacrotuberous ligament, sacrospinous ligament, periostium of a pubic bone, pubourethral ligament, a region of ischial spine, ischial tuberosity, tissue of an obturator, and arcus tendineus.

7. The method according to claim 1 , further comprising securing a distal end of at least one of the first extension portion or the second extension portion to periostium of a pubic bone in a region of ischial tuberosity.

8. The method according to claim 1 , further comprising extending a portion of the pelvic implant through a tissue path between levator ani muscle and obturator internus muscle and attaching at least one of the first extension portion or the second extension portion at an arcus tendineus.

9. The method according to claim 1 , further comprising extending a portion of the pelvic implant through a tissue path between levator muscle and an external incision at a location selected from the group consisting of: a suprapubic incision; a perirectal incision; a perianal incision; an incision in a region of a coccyx; and an incision at an inner thigh, wherein the tissue path extends through an obturator foramen.

10. The method according to claim 1 , wherein the tissue support portion is placed below an external anal sphincter to support the external anal sphincter.

11. The method according to claim 1 , wherein the method includes making an incision selected from the group consisting of:

a small external perirectal incision that can allow a tissue path to extend from an external perirectal incision to levator tissue;

an external suprapubic incision;

an external incision at an inner thigh that connects to the levator tissue through an obturator foramen, a Kraske incision, under a rectum;

an incision at a perineum; and

a vaginal incision, and

inserting an insertion tool, and the implant through the incision.

12. The method according to claim 1 , wherein the method includes dissection of a plane or region of dissection that includes a ischorectal fossa.

13. The method of claim 1 , wherein the first extension portion and the second extension portion are continuously formed with the tissue support portion.

14. A method of treating a pelvic condition by supporting tissue of a pelvic floor, the method comprising:

providing an implant including a tissue support portion, a first extension portion, and a second extension portion, the first extension portion and the second extension portion being integrally formed with the tissue support portion, a first anchor disposed at the first extension portion, and a second anchor disposed at the second extension portion, the tissue support portion including a first side end and a second side end opposite the first side end, a length between the first extension portion and the second extension portion defining a third side end, the third side end being at an angle with respect to at least one of the first side end or the second side end, the third side end including at least two side portions, the at least two side portions being at an angle with respect to each other;

creating an incision that allows access to a region of the pelvic floor;

placing the tissue support portion in contact with the tissue of the pelvic floor;

adjusting a first length of the first extension portion to allow a distal end of the first anchor to reach a desired first tissue of the pelvic region;

securing the first anchor to the first tissue of the pelvic region;

adjusting a second length of the second extension portion to allow a distal end of the second anchor to reach a desired second tissue of the pelvic region; and

securing the second anchor to the second tissue of the pelvic region.

15. The method of claim 14 , wherein the first anchor is a self-fixating tip.

16. The method of claim 14 , wherein the tissue support portion is placed in contact with levator tissue selected from the group consisting of puborectalis tissue, pubococcygeus tissue, perineum tissue, iliococcygeous tissue, and combinations of two or more of these.

17. The method of claim 14 , wherein the pelvic condition is selected from the group consisting of: urinary incontinence, fecal incontinence, enterocele, cystocele, rectocele, and vaginal vault prolapse.

18. The method of claim 14 , wherein the incision is an external medial incision at a perineum.

19. The method of claim 14 , wherein the tissue support portion is further secured to an external anal sphincter.

20. The method according to claim 14 , further comprising treating, in a female, a condition selected from the group consisting of enterocele, cystocele, rectocele, and vaginal vault prolapse.

21. The method according to claim 14 , the method comprising placing the first anchor in a fibrous tissue selected from the group consisting of: a sacrospinous ligament, a sacrotuberous ligament, a coccygeous muscle, a iliococcygeous muscle, an obturator internus muscle, and a region of ischial spine.

Assignments (9)
RELEASE OF SECURITY INTEREST Recorded Apr 26, 2024
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: ACTIENT PHARMACEUTICALS LLC; ASTORA WOMEN’S HEALTH HOLDINGS, LLC; ASTORA WOMEN’S HEALTH LLC; AUXILIUM PHARMACEUTICALS, LLC; AUXILIUM US HOLDINGS, LLC; BIOSPECIFICS TECHNOLOGIES CORP.; BIOSPECIFICS TECHNOLOGIES LLC; DAVA INTERNATIONAL, LLC; DAVA PHARMACEUTICALS, LLC; ENDO GENERIC HOLDINGS, INC. (FORMERLY KNOWN AS PAR PHARMACEUTICALS COMPANIES, INC.); ENDO PHARMACEUTICALS INC.; ENDO PHARMACEUTICALS SOLUTIONS INC. (FORMERLY KNOWN AS INDEVUS PHARMACEUTICALS, INC.); GENERICS BIDCO I, LLC; GENERICS INTERNATIONAL (US), INC.; PAR PHARMACEUTICAL, INC.; PAR STERILE PRODUCTS, LLC (FORMERLY KNOWN AS JHP PHARMACEUTICALS, LLC); QUARTZ SPECIALTY PHARMACEUTICALS, LLC; SLATE PHARMACEUTICALS, LLC; VINTAGE PHARMACEUTICALS, LLC
Reel/Frame 067240/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 12, 2018
From: MONTPETIT, KAREN PILNEY; KALETA, RICHARD C.; KAZMIERKOSKI, JAMES A.; CHAPMAN, KELLY ANN; ANDERSON, KIMBERLY A.
To: AMS RESEARCH CORPORATION
Reel/Frame 044611/0753 →
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 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 →
SECURITY INTEREST Recorded Jun 8, 2017
From: ASTORA WOMEN'S HEALTH, LLC
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 042743/0278 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA NAME PREVIOUSLY RECORDED AT REEL: 037300 FRAME: 0728. ASSIGNOR(S) HEREBY CONFIRMS THE CHANGE OF NAME. Recorded Apr 21, 2017
From: AMS RESEARCH CORPORATION
To: AMS RESEARCH, LLC
Reel/Frame 042308/0630 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2016
From: AMS RESEARCH, LLC
To: APHRODITE WOMEN'S HEALTH, LLC
Reel/Frame 037551/0626 →
CHANGE OF NAME Recorded Jan 18, 2016
From: APHRODITE WOMEN'S HEALTH, LLC
To: ASTORA WOMEN'S HEALTH, LLC
Reel/Frame 037551/0749 →
CHANGE OF NAME Recorded Dec 15, 2015
From: AMS RESEARCH CORPATION
To: AMS RESEARCH, LLC
Reel/Frame 037300/0728 →