CA2557938A1 - Method and apparatus for cystocele repair - Google Patents

Method and apparatus for cystocele repair Download PDF

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Publication number
CA2557938A1
CA2557938A1 CA002557938A CA2557938A CA2557938A1 CA 2557938 A1 CA2557938 A1 CA 2557938A1 CA 002557938 A CA002557938 A CA 002557938A CA 2557938 A CA2557938 A CA 2557938A CA 2557938 A1 CA2557938 A1 CA 2557938A1
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CA
Canada
Prior art keywords
patient
needle
incision
strap
straps
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002557938A
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French (fr)
Other versions
CA2557938C (en
Inventor
Karen Pilney Montpetit
Kimberly A. Anderson
Brian P. Watschke
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AMS Research LLC
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Individual
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Publication of CA2557938A1 publication Critical patent/CA2557938A1/en
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Publication of CA2557938C publication Critical patent/CA2557938C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06009—Means for attaching suture to needle having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/06076—Needles, e.g. needle tip configurations helically or spirally coiled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/3071—Identification means; Administration of patients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0085—Identification means; Administration of patients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0085—Identification means; Administration of patients
    • A61F2250/0087—Identification means; Administration of patients colour-coded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0085—Identification means; Administration of patients
    • A61F2250/0089—Identification means; Administration of patients coded with symbols, e.g. dots, numbers, letters, words

Abstract

An apparatus for repairing cystocele is provided. The apparatus has a support member knitted with a first bar settinq, and straps continuously knitted with the support member. The straps are knitted with a second bar setting.
At least one of the straps has a connector configured to mate with an end of a needle. Kits including needles are also provided.

Claims (28)

1. A method for cystocele repair comprising the steps of:
(a) establishing four pathways in tissue around a bladder of a patient;
(b) introducing a strap into each of said pathways; and (c) positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced;
wherein the step of establishing four pathways in tissue around a bladder of a patient comprises the steps of:
(a - 1) making an incision in said vagina of said patient;
(a - 2) making an incision on a left side of said patient where a left adductor longus tendon of said patient inserts into a left portion of pubic ramus bone of said patient, lateral to an edge of said pubic ramus bone;
(a - 3) making an incision on a right side of said patient where a right adductor longus tendon of said patient inserts into a right portion of said pubic ramus bone of said patient, lateral to said edge of said pubic ramus bone;
(a - 4) making an incision on said left side of said patient where a left inferior edge of the pubic ramus bone of said patient ends at a bottom of a left obturator foramen of said patient; and (a - 5) making an incision on said right side of said patient where a right inferior edge of said pubic ramus bone of said patient ends at a bottom of a right obturator foramen of said patient.
2. The method recited in Claim 1 wherein the step of introducing a strap into each of said pathways comprises the steps of:
(b -1) inserting a needle into each of said respective incisions made in steps (a - 2), (a -3), (a - 4), and (a - 5), said respective incisions a respective entry incision for each respective needle;
(b - 2) advancing each needle through said obturator foramen on a respective side;
(b - 3) further advancing each said needle towards said vaginal incision made in step (a -1) until a tip of said needle extends through said vaginal incision.

(b - 4) attaching a connector fixed to a first end of each respective said strap to said tip of each respective said needle;
(b - 5) withdrawing said tip of each respective said needle back through said vaginal incision, toward a respective entry incision of each said needle, such that said connector and said strap are drawn into said vaginal incision towards said respective entry incision of each said needle; and (b - 6) withdrawing each said needle, each said connector, and each said first end of said strap from said respective entry incisions.
3. The method recited in Claim 1 wherein the step of positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced comprises the steps of:
(c - 1) positioning a leading edge of said support member below the bladder neck;
(c - 2) positioning a trailing edge of the support member at a distal end of said vaginal incision or towards a vaginal apex; and (c - 3) removing a sheath located around each said strap.
4. A method for cystocele repair comprising the steps of:
(a) establishing four pathways in tissue around a bladder of a patient;
(b) atraumatically dilating said pathways;
(c) introducing a strap into each of said pathways while, said pathways are atraumatically dilated; and (d) positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced;
wherein the step of establishing four pathways in tissue around a bladder of a patient comprises the steps of:
(a - 1) making an incision in said vagina of said patient;
(a - 2) making an incision on a left side of said patient where a left adductor longus tendon of said patient inserts into a left portion of a pubic ramus bone of said patient, lateral to an edge of said pubic ramus bone;

(a - 3) making an incision on a right side of said patient where a right adductor longus tendon of said patient inserts into a right portion of said pubic ramus bone of said patient, lateral to said edge of said pubic ramus bone;
(a - 4) making an incision on said left side of said patient where a left inferior edge of said pubic ramus bone of said patient ends at a bottom of a left obturator foramen of said patient; and (a - 5) making an incision on said right side of said patient where a right inferior edge of said pubic ramus bone of said patient ends at a bottom of a right obturator foramen of said patient.
5. The method recited in Claim 4 wherein the step of atraumatically dilating said pathways comprises the steps of:
(b -1) inserting a needle into each of said respective incisions made in steps (a - 2), (a -3), (a - 4), and (a - 5), said respective incisions a respective entry incision for each respective needle; and (b - 2) advancing each said needle through said obturator foramen on a respective side towards said vaginal incision made in step (a - 1) until a tip of said needle extends through said vaginal incision.
6. The method recited in Claim 4 wherein the step of introducing a strap into each of said pathways while said pathways are atraumatically dilated comprises the steps of:
(c - 1) attaching a connector fixed to a first end of each respective said strap to said tip of each respective said needle;
(c - 2) withdrawing said tip of each respective said needle back through said vaginal incision, toward a respective entry incision of each said needle, such that said connector and said strap are drawn into said vaginal incision towards said respective entry incision of each said needle; and (c - 3) withdrawing each said needle, each said connector, and each said first end of said strap from said respective entry incisions.
7. The method recited in Claim 4 wherein the step of positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced comprises the steps of:

(d - 1) positioning a leading edge of said support member below the bladder neck;
(d - 2) positioning a trailing edge of the support member at a distal end of said vaginal incision or towards a vaginal apex; and (d - 3) removing a sheath located around each said strap.
8. An apparatus for repairing cystocele comprising:
a support member knitted with a first bar setting; and a plurality of straps continuously knitted with said support member, said plurality of straps knitted with a second bar setting.
9. The apparatus recited in Claim 8 wherein said support member comprises a substantially rectangular member having two short sides and two long sides, a first end of said rectangular member at a first of said two short sides, a second end of said rectangular member at a second of said two short sides; and said plurality of straps comprise:
a first strap continuously knitted with a first long side proximate said first end of said member;
a second strap continuously knitted with a second long side proximate said first end of said member;
a third strap continuously knitted with a first long side proximate a middle portion of said first long side; and a fourth strap continuously knitted with a second long side proximate a middle portion of said second long side.
10. The apparatus recited in Claim 8 wherein said first bar setting is:
Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2;
Bar 2: 1/0, 2/3, 2/3, 1/0; and Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1.
11. The apparatus recited in Claim 8 wherein said straps and said rectangular member is knitted of polypropylene monofilament material.
12. The apparatus recited in Claim 8 wherein at least one of said straps comprises a tensioning suture.
13. The apparatus recited in Claim 8 where at least one of said straps comprises a connector configured to mate with an end of a needle.
14. The apparatus recited in Claim 8 where at least one of said straps comprises a plastic sheath.
15. The apparatus recited in Claim 14 where said sheath comprises identifying indicia.
16. A kit for repairing cystocele comprising:
a support apparatus comprising at least two straps, each of said straps comprising a connector configured to mate with a tip of a needle;
a first needle configured to extend from an incision on a right side of a patient where a right adductor longus tendon of said patient inserts into a right portion of a pubic ramus bone of said patient, lateral to an edge of said pubic ramus bone, through a right obturator foramen of said patient, to an incision in a vagina of said patient; and a second needle configured to extend from an incision on a left side of said patient where a left adductor longus tendon of said patient inserts into a left portion of said pubic ramus bone of said patient, lateral to an edge of said pubic ramus bone, through a left obturator foramen of said patient, to said incision in said vagina of said patient.
17. The kit recited in Claim 16 wherein said support apparatus comprises a biologic graft.
18. The kit recited in Claim 17 wherein said biologic graft is pre-attached to said at least two straps.
19. The kit recited in Claim 16 wherein said support apparatus comprises:
a pair of straps, each strap having a central portion and a connector at each end of said strap; and a biologic graft connected to said central portion of each strap.
20. The kit recited in Claim 16 wherein said support apparatus comprises a biologic graft fixed over a knitted support member.
21. The kit recited in Claim 16 wherein said support apparatus comprises:
a substantially rectangular member having two short sides and two long sides, a first end of said rectangular member at a first of said two short sides, a second end of said rectangular member at a second of said two short sides;
a first strap connected to a first long side proximate said first end of said member;
a second strap connected to a second long side proximate said first end of said member;
a third strap connected to a first long side proximate a middle portion of said first long side; and a fourth strap connected to a second long side proximate a middle portion of said second long side.
22. The kit recited in Claim 16 wherein said support apparatus comprises:
a support member knitted with a first bar setting; and a plurality of straps continuously knitted with said support member, said plurality of straps knitted with a second bar setting.
23. The apparatus recited in Claim 22 wherein said support member comprises:
a substantially rectangular member having two short sides and two long sides, a first end of said rectangular member at a first of said two short sides, a second end of said rectangular member at a second of said two short sides; and said plurality of straps comprise:
a first strap continuously knitted with a first long side proximate said first end of said member;
a second strap continuously knitted with a second long side proximate said first end of said member;
a third strap continuously knitted with a first long side proximate a middle portion of said first long side; and a fourth strap continuously knitted with a second long side proximate a middle portion of said second long side.
24. The apparatus recited in Claim 22 wherein said first bar setting is:
Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2;
Bar 2: 1/0, 2/3, 2/3, 1/0; and Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1.
25. The kit recited in Claim 16 further comprising:
a third needle configured to extend from an incision on said right side of said patient where a right inferior edge of said pubic ramus bone of said patient ends at a bottom of said right obturator foramen of said patient, through said right obturator foramen of said patient, to said incision in said vagina of said patient; and a fourth needle configured to extend from an incision on said left side of said patient where a left inferior edge of said pubic ramus bone of said patient ends at a bottom of said left obturator foramen of said patient, through said left obturator foramen of said patient, to said incision in said vagina of said patient.
26. A surgical implant kit comprising:
a support apparatus comprising at least two straps, each of said straps comprising a connector configured to mate with a tip of a needle, each connector having an aperture configured to receive said tip of said needle, each aperture having a different shape; and a least two needles, each needle having a tip having a shape configured to mate with said aperture of only one said at least two connectors.
27. A surgical implant kit comprising:
a support apparatus comprising at least two straps, each of said straps comprising a connector configured to mate with a tip of a needle, each connector having identifying indicia thereon; and at least two needles.
28. A surgical implant kit comprising:
a support apparatus comprising at least two straps, each of said straps comprising a connector configured to mate with a tip of a needle, each connector having a color; and at least two needles, each needle having a handle, each handle having a color matching a color of a corresponding connector.
CA002557938A 2004-05-07 2005-05-05 Method and apparatus for cystocele repair Active CA2557938C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/840,646 2004-05-07
US10/840,646 US7351197B2 (en) 2004-05-07 2004-05-07 Method and apparatus for cystocele repair
PCT/US2005/015725 WO2005110274A2 (en) 2004-05-07 2005-05-05 Apparatus for cystocele repair

Publications (2)

Publication Number Publication Date
CA2557938A1 true CA2557938A1 (en) 2005-11-24
CA2557938C CA2557938C (en) 2009-11-24

Family

ID=34967598

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002557938A Active CA2557938C (en) 2004-05-07 2005-05-05 Method and apparatus for cystocele repair

Country Status (5)

Country Link
US (3) US7351197B2 (en)
EP (2) EP1977699B1 (en)
AU (2) AU2005244179B2 (en)
CA (1) CA2557938C (en)
WO (1) WO2005110274A2 (en)

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AU2009233630A1 (en) 2009-11-26
EP1750613B1 (en) 2012-08-15
US7351197B2 (en) 2008-04-01
US7993261B2 (en) 2011-08-09
AU2005244179B2 (en) 2009-07-30
AU2005244179A1 (en) 2005-11-24
US20080183031A1 (en) 2008-07-31
US20110257472A1 (en) 2011-10-20

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