CA2441982A1 - Implant inserted without bone anchors - Google Patents

Implant inserted without bone anchors Download PDF

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Publication number
CA2441982A1
CA2441982A1 CA002441982A CA2441982A CA2441982A1 CA 2441982 A1 CA2441982 A1 CA 2441982A1 CA 002441982 A CA002441982 A CA 002441982A CA 2441982 A CA2441982 A CA 2441982A CA 2441982 A1 CA2441982 A1 CA 2441982A1
Authority
CA
Canada
Prior art keywords
patient
implantable material
implant
fascia
retropubic space
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
CA002441982A
Other languages
French (fr)
Other versions
CA2441982C (en
Inventor
Johann J. Neisz
Kimberly A. Anderson
Brian P. Watschke
Robert E. Lund
James A. Gohman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AMS Research LLC
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Priority to CA2689942A priority Critical patent/CA2689942C/en
Publication of CA2441982A1 publication Critical patent/CA2441982A1/en
Application granted granted Critical
Publication of CA2441982C publication Critical patent/CA2441982C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B17/06109Big needles, either gripped by hand or connectable to a handle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure 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
    • A61F2/0036Closure 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
    • A61F2/0045Support slings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482Needle or suture guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • A61B2017/00495Surgical glue applicators for two-component glue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00805Treatment of female stress urinary incontinence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00946Material properties malleable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0412Suture 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417T-fasteners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427Suture 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
    • A61B2017/0435Suture 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 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427Suture 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
    • A61B2017/0437Suture 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 the barbs being resilient or spring-like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0438Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors slotted, i.e. having a longitudinal slot for enhancing their elasticity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A61B2017/0443Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws the shaft being resilient and having a coiled or helical shape in the released state
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0458Longitudinal through hole, e.g. suture blocked by a distal suture knot
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464Suture 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

Abstract

The present invention discloses an implant (10) for placement in the retropubic space of a patient. Novel methods and assemblies for use in conjunction with the implant are also described. The assemblies comprise at least one deployable member (56) for associating the implant with endopelvic fascia (15) of a retropublic space, and an inserter (80) that is sized and a nd shaped to associate the deployable member with endopelvic fascia.

Claims (30)

1. A method of treating incontinence in a patient comprising the steps of providing an implantable material capable of eliciting a foreign body response, the implantable material being sized and shaped to be placed in the patient's retropubic space without extending through the patient's rectus fascia, placing the implantable material in the retropubic space without securing the implant to substantially fixed anatomical structures such as the patient's pubic bone, periosteum of the pubic bone, Cooper's ligament and rectus fascia; and eliciting a foreign body response with the implantable material.
2. A method according to claim 1 wherein the step of eliciting a foreign body response with the implantable material causes the patient's retropubic space to more closely mimic the retropubic space of a continent individual.
3. A method according to claim 1 wherein the step of placing the implantable material in the retropubic space includes the step of anchoring the implantable material to endopelvic fascia with a mechanical fastener.
4. A method of treating incontinence in a patient comprising the steps of providing an implantable material that is sized and shaped be implanted in the patient's retropubic space and that is capable of eliciting a foreign body response;
placing the implantable material in the retropubic space in a therapeutically effective position relative to the patient's urethra without extending the implantable material to the patient's rectus fascia, without suturing the implant to the patient's Cooper's ligament, and without using bone anchors.
5. A method according to claim 4 wherein the step of providing an implantable material includes the step of providing an implantable material with first and second ends, and the step of placing the implantable material includes the step of associating the first end of the implantable material with endopelvic fascia on' one side of the patient's urethra and associating the second end of the implantable material with endopelvic fascia on the other side of the patient's urethra.
6. A method according to claim 4 wherein the step of placing the implantable material includes the step of placing the implant mid-urethra.
7. A method according to claim 4 wherein the step of placing the implantable material includes the steps of:
passing a deployable anchoring member with an associated suture through endopelvic fascia;
deploying the anchoring member after the anchoring member has substantially passed through endopelvic fascia, and securing the implantable material to the suture associated with the anchoring member.
8. A method according to claim 4 wherein the step of placing the implantable material includes the step of extending the implantable material from the endopelvic fascia on one side of the patient's urethra, underneath approximately the mid-urethra, and to the endopelvic fascia on the other side of the patient's urethra.
9. A method according to claim 4 wherein the step of placing the implantable material includes the step of at least temporarily adhering the implantable material to endopelvic fascia with a tissue adhesive.
10. A method according to claim 9 further including the step of using a foam material.
11. An assembly for placing an implant in a patient's retropubic space during a surgical procedure for treating incontinence, the assembly comprising:

at least one deployable member for associating the implant with endopelvic fascia of a retropubic space; and an inserter that is sized and shaped to associate the deployable member with endopelvic fascia.
12. An assembly according to claim 11 wherein the inserter includes a sheath with a distal end, and a movable member within the sheath, the movable member being operatively associated with the deployable member to move the deployable member between i) a retracted position with the deployable member at least partially received within the sheath of the inserter, and ii) an extended position spaced more distally to the distal end of the sheath than in the retracted position, and wherein movement of the movable member causes the deployable member to move from the retracted position toward the extended position.
13. An assembly according to claim 11 wherein the deployable member is capable of assuming a first orientation that affords at least partial receipt of the deployable member within a sheath of the inserter, and a second orientation that affords secure association between the deployable member and endopelvic fascia.
14. An assembly according to claim 13 wherein the deployable member has a first profile in.the first orientation and a second profile in the second orientation, and wherein the first profile is less than the second profile.
15. An assembly according to claim 11 wherein the deployable member comprises a flexible, substantially disc shape.
16. An assembly according to claim 11 wherein the inserter comprises a tissue adhesive dispenser and the deployable members comprises components of a tissue adhesive.
17. An assembly according to claim 13 wherein the deployable member comprises a substantially clover shaped top portion substantially situated in a first plane, and a stem substantially adapted to be situated in a second plane, and in the first orientation, the first plane is nearly parallel to the second plane, and in the second orientation, the first plane is substantially perpendicular to the second plane.
18. An assembly according to claim 11 wherein the inserter includes a tissue stop for blocking insertion of a distal end of the inserter past preselected endopelvic fascia.
19. An assembly according to claim 13 wherein the movable member is rotatable.
20. An assembly according to claim 13 wherein the movable member is linearly movable relative to the sheath.
21. An assembly according to claim 11 wherein the deployable member comprises a conical spring.
22. An assembly according to claim 11 wherein the deployable member comprises a plurality of anchoring fingers.
23. An assembly according to claim 11 wherein the deployable member comprises an expandable tube that affords movement into tissue in one direction, but that resists movement though tissue in an opposite direction.
24. A kit for a surgical procedure to treat incontinence comprising:
an implant that is sized and shaped to be implanted in a patient's retropubic space;
at least two deployable members for associating the implant with endopelvic fascia of a retropubic space; and an inserter that is sized and shaped to associate the deployable members with endopelvic fascia.
25. An implant for treating incontinence in a patient comprising:
a substantially thin, flexible sheet that has a geometry, size and shape suitable for implanting in the patient's retropubic space without extending through the patient's rectus fascia and without requiring the implant to be secured to substantially fixed anatomical structures such as the patient's pubic bone, periosteum of the pubic bone, Cooper's ligament and rectus fascia.
26. An implant according to claim 25 wherein the sheet is capable of eliciting a foreign body response.
27. An implant according to claim 26 wherein the sheet comprises a synthetic mesh material having a plurality of holes, the holes being sized and shaped to afford tissue ingrowth to anchor the implant in the retropubic space.
28. An implant according to claim 25 wherein the implant is sized and shaped to anchor in the patient's endopelvic fascia.
29. A method of treating fecal incontinence comprising the steps of:
providing an implantable material capable of eliciting a foreign body response, the implantable material being sized and shaped to be placed in the patient's retropubic space without extending through the patient's rectus fascia, placing the implantable material in the retropubic space without securing the implant to substantially fixed anatomical structures such as the patient's pubic bone, periosteum of the pubic bone, Cooper's ligament and rectus fascia; and looping the implantable material underneath the rectum to correct the patient's ano-rectal angle.
30. A method of treating incontinence in a patient comprising the steps of:

providing an implantable material capable of eliciting a foreign body response, the implantable material being sized and shaped to be placed in the patient's retropubic space without extending through the patient's rectus fascia, and securing the implantable material in the retropubic space with a sponge-like substance without securing the implant to substantially fixed anatomical structures such as the patient's pubic bone, periosteum of the pubic bone, Cooper's ligament and rectus fascia.
CA2441982A 2001-03-29 2002-03-28 Implant inserted without bone anchors Expired - Lifetime CA2441982C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2689942A CA2689942C (en) 2001-03-29 2002-03-28 Implant inserted without bone anchors

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US27979401P 2001-03-29 2001-03-29
US60/279,794 2001-03-29
US30292901P 2001-07-03 2001-07-03
US60/302,929 2001-07-03
US30783601P 2001-07-25 2001-07-25
US60/307,836 2001-07-25
US32230901P 2001-09-14 2001-09-14
US60/322,309 2001-09-14
US10/106,086 2002-03-25
US10/106,086 US20020161382A1 (en) 2001-03-29 2002-03-25 Implant inserted without bone anchors
PCT/US2002/009455 WO2002078571A2 (en) 2001-03-29 2002-03-28 Implant inserted without bone anchors

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2689942A Division CA2689942C (en) 2001-03-29 2002-03-28 Implant inserted without bone anchors

Publications (2)

Publication Number Publication Date
CA2441982A1 true CA2441982A1 (en) 2002-10-10
CA2441982C CA2441982C (en) 2011-03-15

Family

ID=39598403

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2689942A Expired - Lifetime CA2689942C (en) 2001-03-29 2002-03-28 Implant inserted without bone anchors
CA2441982A Expired - Lifetime CA2441982C (en) 2001-03-29 2002-03-28 Implant inserted without bone anchors

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2689942A Expired - Lifetime CA2689942C (en) 2001-03-29 2002-03-28 Implant inserted without bone anchors

Country Status (5)

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US (3) US20020161382A1 (en)
EP (2) EP2335645A3 (en)
AU (2) AU2002252521B2 (en)
CA (2) CA2689942C (en)
WO (1) WO2002078571A2 (en)

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EP2335645A2 (en) 2011-06-22
CA2689942A1 (en) 2002-10-10
AU2010202121A1 (en) 2010-06-17
US20060069301A1 (en) 2006-03-30
AU2002252521B2 (en) 2007-07-19
WO2002078571A3 (en) 2003-04-10
WO2002078571A2 (en) 2002-10-10
EP2335645A3 (en) 2011-10-19
CA2441982C (en) 2011-03-15
US20080021264A1 (en) 2008-01-24
AU2010202121B2 (en) 2013-05-02
US20020161382A1 (en) 2002-10-31

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