CA2484290A1 - Improved pelvic health implants and methods - Google Patents

Improved pelvic health implants and methods Download PDF

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Publication number
CA2484290A1
CA2484290A1 CA002484290A CA2484290A CA2484290A1 CA 2484290 A1 CA2484290 A1 CA 2484290A1 CA 002484290 A CA002484290 A CA 002484290A CA 2484290 A CA2484290 A CA 2484290A CA 2484290 A1 CA2484290 A1 CA 2484290A1
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CA
Canada
Prior art keywords
patient
appendage
implant according
surgical implant
posterior
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Granted
Application number
CA002484290A
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French (fr)
Other versions
CA2484290C (en
Inventor
Kimberly A. Anderson
Karen Pilney Montpetit
James E. Cox
John W. Westrum, Jr.
Brian P. Watschke
David R. Staskin
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Individual
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Individual
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Publication date
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Priority to CA2690822A priority Critical patent/CA2690822C/en
Priority to CA2736068A priority patent/CA2736068A1/en
Publication of CA2484290A1 publication Critical patent/CA2484290A1/en
Application granted granted Critical
Publication of CA2484290C publication Critical patent/CA2484290C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • 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
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • 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
    • 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
    • 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
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • 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
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0458—Longitudinal through hole, e.g. suture blocked by a distal suture knot
    • 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
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06014—Means for attaching suture to needle spring-loaded
    • 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
    • A61B2017/06042—Means for attaching suture to needle located close to needle tip
    • 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
    • A61B2017/06085—Needles, e.g. needle tip configurations having a blunt tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • 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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0072—Delivery tools therefor

Abstract

Surgical articles, implants and components suitable for female pelvic health procedures are described.

Claims (39)

1. A surgical implant for addressing a female patient's pelvic health disorder comprising:
a mesh having a major portion that is sized and shaped to afford repair of a cystocele without lifting the patient's bladder and without placing tension on the bladder, the major portion including a urethral support portion capable of being placed underneath the patient's urethra;
a first sling appendage for securement on a first side of the patient's urethra; and a second sling appendage for securement on a side of the patient's urethra generally opposite the first side.
2. A surgical implant according to claim 1 wherein the first sling appendage is sized, shaped and configured to extend from a region near the patient's urethra to the patient's abdominal rectus fascia, on a first side of the patient's urethra, and the second sling appendage is sized, shaped and configured to extend from a region near the patient's urethra to the patient's abdominal rectus fascia, on a side of the patient's urethra generally opposite the first side.
3. A surgical implant according to claim 1 wherein the first sling appendage is sized, shaped and configured to extend from a region near the patient's urethra to the patient's obturator foramen, on a first side of the patient's urethra, and the second sling appendage is sized, shaped and configured to extend from a region near the patient's urethra to the patient's other obturator foramen, on a side of the patient's urethra generally opposite the first side.
4. A surgical implant according to claim 1 wherein the mesh material comprises bulk knitted polypropylene monofilaments, and bulk material from which the mesh is supplied has at least a Longitudinal Elongation Factor (LEF) of 0.06 under a 1/2 pound load.
5. A surgical implant according to claim 1 wherein the implant is a composite constructed of two different implantable materials.
6. A surgical implant according to claim 1 wherein the major portion has a length sufficient to afford anchoring in the region of the patient's sacrum.
7. A surgical implant for addressing a female patient's pelvic health disorder comprising:
a synthetic mesh material having a portion adapted to be secured in the patient's vaginal region, a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region to a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, to a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision; and bulk material from which the mesh is supplied has at least a Longitudinal Elongation Factor (LEF) of at least 0.06 under 1/2 pound load.
8. A surgical implant according to claim 7 wherein the first and second posterior securement appendages have distal end regions adapted to be secured in the patients ischiorectal fossa.
9. A surgical implant according to claim 7 wherein the portion adapted to be secured in the patient's vaginal region is sized and shaped to afford repair of a cystocele.
10. A surgical implant according to claim 7 further including a portion that is sized and shaped to afford repair of a rectocele.
11. A surgical implant according to claim 7 wherein bulk material from which the mesh is supplied has at least a Longitudinal Elongation Factor (LEF) of more than about 0.08 under a 1/2 pound load.
12. A surgical implant according to claim 11 wherein bulk material from which the mesh is supplied has at least a Longitudinal Elongation Factor (LEF) of more than about 0.15 under a 1/2 pound load.
13. A surgical implant according to claim 7 wherein bulk material from which the mesh is supplied has a Longitudinal Elongation Factor (LEF) of more than about 0.08 under a 1 pound load.
14. A surgical implant according to claim 13 wherein bulk material from which the mesh is supplied has a Longitudinal Elongation Factor (LEF) of more than about 0.1 under a 1 pound load.
15. A surgical implant according to claim 14 wherein bulk material from which the mesh is supplied has a Longitudinal Elongation Factor (LEF) of more than about 0.2 under a 1 pound load.
16. A surgical implant for addressing a female patient's pelvic health disorder comprising:
a synthetic mesh material having a portion adapted to be secured in the patient's vaginal region, a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision, a first flexible insertion sheath associated with at least a portion of the first posterior securement appendage, and a second flexible insertion sheath associated with at least a portion of the second posterior securement appendage.
17. A surgical implant according to claim 16 wherein the first and second posterior securement appendages have distal end regions adapted to be secured in the patient's ischioanal fossa.
18. A surgical implant according to claim 16 wherein the first and second posterior securement appendages have distal end regions adapted to be secured in the patient's sacrospinous ligaments.
19. A surgical implant according to claim 16 wherein the first and second posterior securement appendages have distal end regions adapted to be secured in the patient's uterosacral ligaments.
20. A surgical implant according to claim 16 wherein the first and second posterior securement appendages have distal end regions adapted to be secured in the patient's levator ani tissue.
21. A surgical implant according to claim 16 further including a first dilator associated with the first posterior securement appendage, and a second dilator associated with the second posterior securement appendage.
22. A surgical implant according to claim 16 further including a first connector capable of associating the first securement appendage with a needle, and a second connector capable of associating the second securement appendage with a needle.
23. A surgical implant for addressing incontinence and cystocele disorders comprising:
a synthetic mesh material having a cystocele repair portion adapted to be secured in the patient's vaginal region, a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision, the implant including a urethral support portion capable of being placed underneath the patient's urethra;
a first sling appendage for securement on a first side of the patient's urethra; and a second sling appendage for securement on a side of the patient's urethra generally opposite the first side of the urethra.
24. A surgical assembly for addressing a female patient's pelvic health disorder comprising:
a synthetic mesh material having a portion adapted to be secured in the patient's vaginal region, a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision, the first and second posterior securement appendages including a connector for associating the first and second posterior securement appendages with a distal end of an insertion needle.
25. An assembly according to claim 24 wherein the connectors include surfaces for dilating tissue.
26. An assembly for addressing a female patient's pelvic health disorder comprising:
a first insertion needle having a distal end;
a second insertion needle having a distal end;
the first and second insertion needles being configured so that the distal end may be initially inserted through an incision in the patient's buttocks and then passed through tissue, emerging through a vaginal incision; and an implant comprising a synthetic mesh material having a portion adapted to be secured in the patient's vaginal region, a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision, a first flexible insertion sheath associated with at least a portion of the first posterior securement appendage, and a second flexible insertion sheath associated with at least a portion of the second posterior securement appendage.
27. An assembly according to claim 26 wherein the portion of the implant adapted to be secured in the patient's vaginal region is adapted to be sutured to the patient's vaginal apex.
28. An assembly according to claim 26 further including first and second dilating connectors attached to the first and second flexible insertion sheaths for affording association between the implant and the distal ends of the first and second insertion needles.
29. A surgical implant for addressing a female patient's pelvic floor disorder comprising:
a synthetic mesh having a major portion, and at least four projections extending from the major portion, one of said projections adapted to be placed on a first side of the patient's urethra and extend from the patient's urethral region to the patient abdominal rectus fascia, and another of said projections adapted to be placed on a side of the patient's urethra generally opposite the first side.
30. A surgical implant according to claim 29 wherein the synthetic mesh comprises a knitted polypropylene.
31. An implant according to claim 29 further including a connector for associating the implant with an insertion needle.
32. An implant according to claim 29 including four connectors for associating the implant with four insertion needles.
33. An implant according to claim 29 wherein the implant affords cystocele repair.
34. An implant according to claim 29 wherein the implant affords vaginal vault prolapse repair.
35. An implant according to claim 29 wherein the projections are associated with insertion sheaths for aiding in implantation of the implant.
36. An implant according to claim 29 wherein the implant affords enterocele repair.
37. A modular assembly for affording construction of a surgical implant for addressing one or more pelvic floor disorders comprising:
an anterior element for affording a sling-like implant;
a posterior element for securement in a posterior region of the patient's body; and a cystocele repair portion for affording repair of a cystocele, wherein the cystocele repair portion may be associated with either the anterior element or the posterior element or both elements.
38. An assembly according to claim 37 further including a means for facilitating association between elements of the assembly.
39. An assembly according to claim 37 wherein the cystocele repair portion includes indicia to facilitate trimming to adjust the implant to different sizes.
CA2484290A 2002-05-15 2003-04-28 Improved pelvic health implants and methods Expired - Lifetime CA2484290C (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA2690822A CA2690822C (en) 2002-05-15 2003-04-28 Improved pelvic health implants and methods
CA2736068A CA2736068A1 (en) 2002-05-15 2003-04-28 Improved pelvic health implants and methods

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US38059102P 2002-05-15 2002-05-15
US60/380,591 2002-05-15
US45675003P 2003-03-21 2003-03-21
US60/456,750 2003-03-21
US10/423,662 2003-04-25
US10/423,662 US7407480B2 (en) 2001-07-27 2003-04-25 Method and apparatus for correction of urinary and gynecological pathologies, including treatment of incontinence cystocele
PCT/US2003/013113 WO2003096929A1 (en) 2002-05-15 2003-04-28 Improved pelvic health implants and methods

Related Child Applications (2)

Application Number Title Priority Date Filing Date
CA2690822A Division CA2690822C (en) 2002-05-15 2003-04-28 Improved pelvic health implants and methods
CA2736068A Division CA2736068A1 (en) 2002-05-15 2003-04-28 Improved pelvic health implants and methods

Publications (2)

Publication Number Publication Date
CA2484290A1 true CA2484290A1 (en) 2003-11-27
CA2484290C CA2484290C (en) 2011-07-26

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Family Applications (1)

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CA2484290A Expired - Lifetime CA2484290C (en) 2002-05-15 2003-04-28 Improved pelvic health implants and methods

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US (4) US7407480B2 (en)
EP (1) EP1503696A1 (en)
AU (2) AU2003234261C1 (en)
CA (1) CA2484290C (en)
WO (1) WO2003096929A1 (en)

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