WO2009038781A4 - Pelvic floor treatments and related tools and implants - Google Patents

Pelvic floor treatments and related tools and implants Download PDF

Info

Publication number
WO2009038781A4
WO2009038781A4 PCT/US2008/010926 US2008010926W WO2009038781A4 WO 2009038781 A4 WO2009038781 A4 WO 2009038781A4 US 2008010926 W US2008010926 W US 2008010926W WO 2009038781 A4 WO2009038781 A4 WO 2009038781A4
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
tissue
shaft
combination
configuration
Prior art date
Application number
PCT/US2008/010926
Other languages
French (fr)
Other versions
WO2009038781A1 (en
Inventor
Chaouki Ahmad Khamis
David J Kupiecki
Jeffrey M O'hern
Sean Michael Wignall
Original Assignee
Ams Res Corp
Chaouki Ahmad Khamis
David J Kupiecki
Jeffrey M O'hern
Sean Michael Wignall
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority to JP2010525842A priority Critical patent/JP5313251B2/en
Priority to US12/678,923 priority patent/US8708885B2/en
Priority to AU2008302768A priority patent/AU2008302768B2/en
Priority to KR1020107006499A priority patent/KR101547488B1/en
Priority to CN200880113558.3A priority patent/CN101842060B/en
Priority to EP08832443A priority patent/EP2194913A1/en
Application filed by Ams Res Corp, Chaouki Ahmad Khamis, David J Kupiecki, Jeffrey M O'hern, Sean Michael Wignall filed Critical Ams Res Corp
Priority to CA2698558A priority patent/CA2698558C/en
Priority to BRPI0817018 priority patent/BRPI0817018A2/en
Publication of WO2009038781A1 publication Critical patent/WO2009038781A1/en
Publication of WO2009038781A4 publication Critical patent/WO2009038781A4/en
Priority to US14/263,184 priority patent/US9333065B2/en
Priority to US15/149,692 priority patent/US10010394B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • 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
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • 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
    • A61B2017/0409—Instruments for applying 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0412—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
    • 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
    • A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • 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
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
    • 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

Described are implants, tools, and methods useful for treating pelvic conditions such as prolapse, by placing an implant to support pelvic tissue, the implants, tools, and methods involving one or more of an insertion tool that works in coordination with a sheath, adjusting engagements, specific implants and pieces of implants, placement of implants at locations within the pelvic region, and insertion, adjusting, and grommet management tools.

Claims

48
AMENDED CLAIMS received by the International Bureau on 11 March 2009 (11.03.2009)
1. A surgical insertion tool useful for implanting a pelvic implant, the tool comprising a handle, a shaft comprising a proximal shaft end attached to the handle, and a distal shaft end, a sheath that engages the shaft and allows at least two configurations: a covered configuration in which the sheath covers the distal shaft end, and an uncovered configuration in which the sheath covers a portion of the shaft and does not cover the distal shaft end, wherein: in the covered configuration the sheath covers the distal shaft end and the proximal shaft end, and in the uncovered configuration the sheath covers the proximal shaft end and not the distal shaft end.
3. The tool of claim 1 wherein the sheath is a hollow polymeric tube.
4. A tool according to claim 1 or 3 wherein the sheath is a hollow polymeric tube, the sheath can slide over the distal shaft end to place the sheath in the covered configuration, the sheath engages a mechanical stop when in the covered configuration, the mechanical stop can be removed and the sheath can be placed in the uncovered configuration.
5. A tool according to claim 4 wherein the mechanical stop comprises a moveable extension that can be moved to engage or disengage the sheath by an actuator located on the handle. 49
6. A tool according to claim 4 or 5 wherein the hollow tube sheath comprises a proximal tube end and a distal tube end, the handle comprises a recess at a connection of the handle to the shaft proximal end, the recess being capable of accepting the proximal end of the hollow tube sheath, the hollow tube sheath moves from the covered configuration to the uncovered configuration by the proximal tube end moving in a direction toward the recess.
7. A tool according to claim 5 wherein the hollow tube sheath comprises an aperture in a sidewall at the proximal tube end, in the covered configuration, the extension is located within the aperture and inhibits movement of the hollow tube sheath in a proximal direction and in a distal direction along the shaft, the extension can be removed from the aperture to allow the hollow tube to be placed in the uncovered configuration.
8. A tool according to any of claims 1 and 3 through 7 wherein, in the uncovered configuration, a length of from 0.5 to 1.5 centimeters of the distal end of the shaft is uncovered.
9. In combination, a tool as recited in any of claims 1 and 3 through 8, in combination with an extension portion of an implant, wherein the extension portion comprises a tissue fastener at a distal eπd, the tissue fastener is capable of engaging a distal end of the shaft.
10. The combination of claim 9 wherein the extension portion is an extension portion piece, the combination further comprising a support portion piece. 50
1 1. A combination as recited in claims 9 or 10, wherein when the tissue fastener engages the distal end of the shaft, the sheath can fit over the shaft, the sheath can be moved between the covered configuration and the uncovered configuration, and the sheath covers the self-fixating tip when the sheath is in the covered configuration and the sheath does not cover the self-fixating tip when the sheath is in the uncovered configuration.
12. A combination as recited in any of claims 9 through 11, wherein the implant comprises a tissue support portion, and a set of two superior extension portions extending from the tissue support portion, and a set of two inferior extension portions extending from the tissue support portion, wherein, when the tissue support portion is placed to support tissue of a vagina, each superior extension portion can be connected to tissue of an opposing obturator foramen, and each inferior extension portion can be connected to sacrospinous ligament.
13. A combination as recited in any of claimS'9 through 12, comprising one or more of a grommet management tool and an adjusting tool.
14. A combination as recited in any of claims 9 through 13, wherein the tool as recited in any of claims 1 and 3 through 8 is adapted to engage a tissue fastener and to place the tissue fastener transvaginally at a sacrospinous ligament, the combination further comprising a second insertion tool adapted to place a tissue fastener transvaginally at an obturator foramen. 51
15. A method of implanting an implant in a patient, the method comprising providing a combination of tool as recited in any of claims 1 and 3 through 8, and an implant, the implant comprising an extension portion comprising a tissue fastener at a distal shaft end, engaging the tissue fastener with the distal shaft end, placing the sheath over the shaft and engaged tissue fastener with the sheath in a covered configuration that covers the distal shaft end and engaged tissue fastener, inserting the shaft and engaged tissue fastener into a patient, with the sheath placed over the shaft in the covered configuration, moving the sheath to an uncovered configuration that uncovers the tissue fastener, and fastening the tissue fastener to tissue.
16. The method of claim 15 comprising inserting the tissue fastener into soft tissue selected from sacrospinous ligament and coccygeus muscle.
17. The method of claim 16 wherein the implant comprises a tissue support portion, and a set of two superior extension portions extending from the tissue support portion, and a set of two inferior extension portions extending from the tissue support portion, the method comprising placing the tissue support portion to support tissue of a vagina, fixing each superior extension portion to tissue of an opposing obturator foramen, fixing each inferior extension portion to soft tissue of sacrospinous ligament or coccygeus muscle.
18. The combination of claim 10 wherein the extension portion piece comprises a mesh portion and a non-mesh portion.
19. The combination of claim 18 wherein the extension portion piece comprises a tissue fastener at an end of the mesh portion.
20. The combination of claim 18 wherein the support portion piece comprises an adjusting engagement for adjustably engaging the extension portion piece.
21. The combination of claim 20 wherein the support portion piece further comprises two additional tissue fasteners.
PCT/US2008/010926 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants WO2009038781A1 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
US12/678,923 US8708885B2 (en) 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants
AU2008302768A AU2008302768B2 (en) 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants
KR1020107006499A KR101547488B1 (en) 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants
CN200880113558.3A CN101842060B (en) 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants
EP08832443A EP2194913A1 (en) 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants
JP2010525842A JP5313251B2 (en) 2007-09-21 2008-09-19 Pelvic floor treatment-related tools and implants
CA2698558A CA2698558C (en) 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants
BRPI0817018 BRPI0817018A2 (en) 2007-09-21 2008-09-19 Surgical insertion tool, tool combination with an implant extension, and method for implanting an implant in a patient
US14/263,184 US9333065B2 (en) 2007-09-21 2014-04-28 Pelvic floor treatments and related tools and implants
US15/149,692 US10010394B2 (en) 2007-09-21 2016-05-09 Pelvic floor treatments and related tools and implants

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US97431407P 2007-09-21 2007-09-21
US60/974,314 2007-09-21
US1226007P 2007-12-07 2007-12-07
US61/012,260 2007-12-07

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/678,923 A-371-Of-International US8708885B2 (en) 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants
US14/263,184 Continuation US9333065B2 (en) 2007-09-21 2014-04-28 Pelvic floor treatments and related tools and implants

Publications (2)

Publication Number Publication Date
WO2009038781A1 WO2009038781A1 (en) 2009-03-26
WO2009038781A4 true WO2009038781A4 (en) 2009-05-07

Family

ID=39967107

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/010926 WO2009038781A1 (en) 2007-09-21 2008-09-19 Pelvic floor treatments and related tools and implants

Country Status (10)

Country Link
US (3) US8708885B2 (en)
EP (1) EP2194913A1 (en)
JP (1) JP5313251B2 (en)
KR (1) KR101547488B1 (en)
CN (2) CN101842060B (en)
AU (1) AU2008302768B2 (en)
BR (1) BRPI0817018A2 (en)
CA (1) CA2698558C (en)
HK (1) HK1203341A1 (en)
WO (1) WO2009038781A1 (en)

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JP5313251B2 (en) 2013-10-09
US9333065B2 (en) 2016-05-10
CA2698558C (en) 2015-11-17
CA2698558A1 (en) 2009-03-26
JP2010540020A (en) 2010-12-24
HK1203341A1 (en) 2015-10-30
CN104138278B (en) 2017-10-24
AU2008302768A1 (en) 2009-03-26
AU2008302768B2 (en) 2014-01-23
US10010394B2 (en) 2018-07-03
EP2194913A1 (en) 2010-06-16
US20100274074A1 (en) 2010-10-28
CN104138278A (en) 2014-11-12
KR101547488B1 (en) 2015-08-26
US20140235935A1 (en) 2014-08-21
WO2009038781A1 (en) 2009-03-26
CN101842060A (en) 2010-09-22
US20160287368A1 (en) 2016-10-06
CN101842060B (en) 2014-07-16
KR20100065337A (en) 2010-06-16
US8708885B2 (en) 2014-04-29

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