WO2011082220A1 - Elongate implant system and method for treating pelvic conditions - Google Patents

Elongate implant system and method for treating pelvic conditions Download PDF

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Publication number
WO2011082220A1
WO2011082220A1 PCT/US2010/062342 US2010062342W WO2011082220A1 WO 2011082220 A1 WO2011082220 A1 WO 2011082220A1 US 2010062342 W US2010062342 W US 2010062342W WO 2011082220 A1 WO2011082220 A1 WO 2011082220A1
Authority
WO
WIPO (PCT)
Prior art keywords
implants
elongate
vagina
stab incisions
patient
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.)
Ceased
Application number
PCT/US2010/062342
Other languages
English (en)
French (fr)
Inventor
Chaouki A. Khamis
James A. Alexander
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
AMS Research LLC
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 AMS Research LLC filed Critical AMS Research LLC
Priority to AU2010339575A priority Critical patent/AU2010339575B2/en
Priority to BR112012015838A priority patent/BR112012015838A2/pt
Priority to CN201080060071.0A priority patent/CN102740797A/zh
Priority to EP10841672.8A priority patent/EP2519185A4/en
Priority to CA2785560A priority patent/CA2785560A1/en
Priority to JP2012547263A priority patent/JP2013516236A/ja
Priority to US13/520,138 priority patent/US10470861B2/en
Publication of WO2011082220A1 publication Critical patent/WO2011082220A1/en
Anticipated expiration legal-status Critical
Ceased 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
    • A61F2/0004—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
    • 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
    • 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

Definitions

  • the present invention relates generally to surgical methods and apparatus and, more specifically, to minimally invasive prolapse repair via needles, and methods for forming and using the same.
  • Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population.
  • Examples of common pelvic ailments include incontinence (e.g. , fecal and urinary), pelvic tissue prolapse (e.g. , female vaginal prolapse), and conditions of the pelvic floor.
  • Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others.
  • Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse.
  • a cystocele is a hernia of the bladder, usually into the vagina and introitus. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems.
  • Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine.
  • Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed.
  • vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina.
  • An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times.
  • Fecal incontinence like urinary incontinence, has proven to be challenging to treat. Patients whose fecal incontinence is caused by external anal sphincter injury is treated surgically, as with a sphincteroplasty. Other patients are considered to have neurogenic or idiopathic fecal incontinence and efforts to treat these patients have been less successful. Various procedures, such as postanal repair, total pelvic floor repair, muscle transposition techniques, dynamic graciloplasty, artificial sphincter procedures, and sacral nerve stimulation. Success has been limited, and the various treatment modalities can result in morbidity.
  • the present invention describes systems, needles and methods for treating pelvic conditions such as incontinence, vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other pelvic conditions caused by muscle and ligament weakness.
  • Embodiments of the systems can include one or more needles, such as those used in pelvic floor repair procedures.
  • a syringe or similar style hollow needle can be used to deliver elongate mesh or other implant devices through one or more small stab incisions into the target tissue location inside the pelvis.
  • the implant devices can be placed upon insertion through the incisions to engage and pull or tighten support tissue, e.g.
  • the devices can include one or more mesh members, rods, or braided members adapted to support the respective target tissue or organs.
  • the implant devices can engage, pull or otherwise tension tissue to cause the tissue to tighten and provide slack reduction for improved support.
  • embodiments of the implants can be utilized to eliminate the need for mesh or other supportive structures under the urethra that is common with incontinence slings.
  • the present invention can include surgical instruments, implantable articles, and methods for urological applications, particularly for the treatment of stress and/or urge urinary incontinence, fecal incontinence, and prolapse and perineal floor repairs.
  • the usual treatments for incontinence include placing a sling to either compress the urethral sphincter or to elevate or support the neck of the bladder defects.
  • Fig. 1 shows a cross-sectional schematic view of various relevant structures of the female anatomy in accordance with implantation of the present invention.
  • Fig. 2 shows a delivery tool in accordance with embodiments of the present invention.
  • Figs. 3-6 show exemplary elongate implants in accordance with embodiments of the present invention.
  • Fig. 7 shows a female patient and relevant anatomical structure.
  • Fig. 8 shows a female patient with an expanded vagina in preparation for implantation in accordance with embodiments of the present invention.
  • Figs. 9-11 show implantation of elongate implants within stab incisions in accordance with embodiments of the present invention.
  • Fig. 12 shows a cross-section schematic view of various relevant anatomical structures and deployed elongate implants in accordance with embodiments of the present invention.
  • FIG. 1-12 various embodiments of pelvic repair systems 10 are disclosed.
  • One aspect of the present invention is an apparatus and method of treating urinary incontinence in males or females.
  • one or more implants or implant members are placed in strategically located positions to pull up or otherwise tighten tissue and/or muscle lateral to the urethra, or anterior or posterior to the vagina, to generally re-establish the original anatomical structure of the patient.
  • Structures or portions of the various embodiments detailed herein can be constructed of materials such as polypropylene, polyglycolide, poly-l-lactides, or other known biodegradable (re-absorbable) or non-biodegradable polymers. Further, growth factors or stem cells can be seeded or otherwise provided with one or more of the components of the devices to facilitate healing or tissue in-growth. In addition to introduction and deployment of the devices or components with a needle introducer device, a cannula or catheter system can be utilized as well.
  • Fig. 1 shows the general anatomical structure of the female anatomy, including the Urethra U, Vagina V, and Anus A.
  • the systems 10 can include one or more syringe or needle devices 12, as shown in Fig. 2.
  • the needle devices 12 can include a hollow needle portion 14 and a handle portion 16.
  • the need portion 14 can include an internal lumen adapted to receive, deploy and release one or more implants 18.
  • the hollow needle portion 14 can include a distal tip 20 adapted to create and traverse one or more small stab incisions proximate (e.g. , anterior or posterior) the Vagina V.
  • the needle portion 14 can be straight, curved or helical.
  • the device 12 can include one or more actuation or trigger mechanisms adapted to selectively retain or deploy one or more implants 18 from the device 12 (e.g. , needle lumen).
  • the distal tip 20 and at least a portion of the needle portion 14 are adapted for insertion to create and traversal into the stab incisions into the target tissue location inside the pelvis of the patient.
  • the various systems 10, implants, tools, features and methods detailed herein are envisioned for use with or can utilize all or part of the known implant and repair systems (e.g. , for male and female), features and methods, including those disclosed in U.S. Patent Nos.
  • Figs. 3-6 show various exemplary embodiments of the implants 18.
  • the implants are constructed in an elongate or rod-shaped construct.
  • the implants 18 can be shaped, constructed or formed as elongate mesh strips (Fig. 6), elongate rods (Fig. 5), or braided rods (Fig. 3).
  • various embodiments of the implants 18 can include one or more end anchors 22 to facilitate tissue engagement and retention during deployment and positioning.
  • portions of the implants 18 can include extending members, protrusions, barbs, tines, surface roughness, surface edges or like features to facilitate tissue fixation of the implant 18 upon deployment.
  • Figs. 7- 12 various available steps or procedures for the pelvic repair system 10 are depicted.
  • the patient is placed in the supine position, as shown in Fig. 7.
  • the vagina V is then expanded, as demonstrated in Fig. 8.
  • Various known tools, retractors, balloons or like devices and procedures can be utilized to achieve this vaginal expansion.
  • One or more of the needle devices 12 are provided for external penetration or stab incisions proximate or along the periphery of the vagina V.
  • the stab incisions can be first made by the physician with a surgical tool and then the needle devices 12 can be introduced to deploy the needle 14 and implants 18 through the one or more stab incisions.
  • the needle device 12 can be inserted through the one or more incisions to deploy the implant 18 (e.g. , mesh, rod, braided material, or a like implant) into and from the inner lumen of the needle 14. Then, while holding the implant 18 in place, the hollow tube needle 14 is extracted to leave the implant 18 in place for pelvic floor support. A number of these steps can be repeated until the desired number of needles or implants are deployed, or the desired support is achieved.
  • the configurations of the present invention provide a system adapted to control the depth of the implant to provide consistency and optimal placement. Further, the distal tip 20 or needle 14, and the implant 18, are adapted to penetrate target tissue or anatomical structure within the pelvis, around the vagina V to provide the desired engagement and tissue support to address the incontinence or prolapse weaknesses.
  • the needle 14 is adapted for insertion through the stab incisions such that the implants 18 can be inserted into or otherwise engaged with internal support tissue around the vagina, urethra and the like, e.g. , pubocervical fascia, rectovaginal fascia, endopelvic fascia, levator muscles, just to name a few.
  • the spacing, placement and pattern for deploying implants 18 can vary greatly.
  • Various anterior patterned (relative to vagina) and positioned implants 18 are shown in Figs. 9 and 11.
  • Fig. 10 shows an exemplary posterior pattern and positioning for the implants 18.
  • Fig. 12 demonstrates various exemplary implants 18 deployed and engaged within the patient to provide the desired support and tensioning of the present invention.
  • the implants 18 can extend into the pelvic region or target engagement tissue a full length of the relative organ or lumen (e.g. , urethra U or vagina V), or along a distance short of the entire organ or lumen length.
  • Embodiments of the present invention provide key advantages over conventional methods and systems, including controlled implant depth to reduce implant variation, reduced risk of extrusion or erosion, reduced recovery time because of the lack of large incisions, blunt dissections, sutures, and the like.
  • Various portions of the systems 10 can be constructed of known or compatible polymer or metal materials (e.g. , Nitinol).
  • Alternative embodiments of the present invention can be used to restore levator ani structures to provide further support.
  • Use of the system to restore or support other anatomical structures are envisioned as well.
  • guided catheter tools or systems, magnetically guided sensors and tools, and other known devices and delivery systems can be employed with the present invention as well.

Landscapes

  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
PCT/US2010/062342 2009-12-30 2010-12-29 Elongate implant system and method for treating pelvic conditions Ceased WO2011082220A1 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
AU2010339575A AU2010339575B2 (en) 2009-12-30 2010-12-29 Elongate implant system and method for treating pelvic conditions
BR112012015838A BR112012015838A2 (pt) 2009-12-30 2010-12-29 sistema de reparo do assoalho pélvico, sistema de implante para tratar distúrbios pélvicos, e, método para tratar um distúrbio pélvico
CN201080060071.0A CN102740797A (zh) 2009-12-30 2010-12-29 用于治疗骨盆病状的细长植入系统和方法
EP10841672.8A EP2519185A4 (en) 2009-12-30 2010-12-29 Elongate implant system and method for treating pelvic conditions
CA2785560A CA2785560A1 (en) 2009-12-30 2010-12-29 Elongate implant system and method for treating pelvic conditions
JP2012547263A JP2013516236A (ja) 2009-12-30 2010-12-29 骨盤疾患を治療するための細長い移植片システムおよび方法
US13/520,138 US10470861B2 (en) 2009-12-30 2010-12-29 Elongate implant system and method for treating pelvic conditions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US29103109P 2009-12-30 2009-12-30
US61/291,031 2009-12-30

Publications (1)

Publication Number Publication Date
WO2011082220A1 true WO2011082220A1 (en) 2011-07-07

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/062342 Ceased WO2011082220A1 (en) 2009-12-30 2010-12-29 Elongate implant system and method for treating pelvic conditions

Country Status (9)

Country Link
US (1) US10470861B2 (enExample)
EP (1) EP2519185A4 (enExample)
JP (2) JP2013516236A (enExample)
KR (1) KR20120098806A (enExample)
CN (1) CN102740797A (enExample)
AU (1) AU2010339575B2 (enExample)
BR (1) BR112012015838A2 (enExample)
CA (1) CA2785560A1 (enExample)
WO (1) WO2011082220A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101349210B1 (ko) 2012-06-26 2014-01-08 손고운 질 성형 임플란트용 시술 도구

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NZ718101A (en) 2008-05-01 2017-07-28 Convatec Technologies Inc Rectal drain appliance
CA2834848C (en) 2011-03-17 2019-06-11 Convatec Technologies Inc. High barrier elastomer fecal catheter or ostomy pouch
BR112016002257A2 (pt) 2013-08-01 2017-12-12 Convatec Technologies Inc conector de saco de fechamento automático
CN114587492B (zh) 2015-11-25 2025-01-03 软骨解决方案股份有限公司 可植入矫形设备
GB201721956D0 (en) 2017-12-27 2018-02-07 Convatec Ltd Female catheter locator tip
GB201721955D0 (en) 2017-12-27 2018-02-07 Convatec Ltd Catheter wetting devices
SG11202111856RA (en) 2019-06-11 2021-11-29 Convatec Technologies Inc Urine collection bags for use with catheter products, kits incorporating the same, and methods therefor
CN116965894A (zh) * 2023-07-27 2023-10-31 北京大学第一医院 羊膜囊穿刺、羊水收集、羊膜囊封堵及催产多功能装置
USD1098434S1 (en) 2025-04-29 2025-10-14 Allosource Implant for pelvic organ prolapse

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EP2519185A4 (en) 2018-01-24
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