WO2000009039A1 - Sangle pour la vessie - Google Patents

Sangle pour la vessie Download PDF

Info

Publication number
WO2000009039A1
WO2000009039A1 PCT/US1999/017474 US9917474W WO0009039A1 WO 2000009039 A1 WO2000009039 A1 WO 2000009039A1 US 9917474 W US9917474 W US 9917474W WO 0009039 A1 WO0009039 A1 WO 0009039A1
Authority
WO
WIPO (PCT)
Prior art keywords
support
sling
urethra
sutures
stretchable
Prior art date
Application number
PCT/US1999/017474
Other languages
English (en)
Inventor
Claude Tihon
Mark A. Rydell
William P. Ryan
Original Assignee
Contimed, Inc.
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 claimed from US09/133,596 external-priority patent/US6042536A/en
Application filed by Contimed, Inc. filed Critical Contimed, Inc.
Priority to EP99945008A priority Critical patent/EP1065992A4/fr
Publication of WO2000009039A1 publication Critical patent/WO2000009039A1/fr

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
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors 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
    • A61F2/0004—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
    • 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
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A61B2017/0225—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery flexible, e.g. fabrics, meshes, or membranes
    • 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
    • A61B17/06166—Sutures
    • A61B2017/0618—Sutures elastic, e.g. stretchable

Definitions

  • This invention relates generally to the treatment of urinary incontinence. More specifically, this invention relates to our improved sling that can be surgically implanted to support the urethra and bladder neck to mitigate the involuntary discharge of urine from the bladder.
  • Urinary incontinence is a common problem, especially in women. It is estimated that there are over 13 million individuals with urinary incontinence in the United States, of which about 85% are women. Stress urinary continence is a condition in which the patient leaks urine when a sudden increase in his or her abdominal pressure occurs. This increase in abdominal pressure can result from many routine daily activities such as laughing, sneezing, walking, or getting up from a chair.
  • the materials used to create the sling include excised native retus fascia and fascia lata from the patient. More recently, chemically treated cadaveric fascia lata has been used. Some synthetic materials have also been used. These included woven sheets made of polypropylene, Dacron, and other flexible but non-elastic material. Synthetic slings have also been coated with collagen products, such as Protegen, which is marketed by Boston Scientific Corporation. Protegen is a rigid woven material coated with collagen which is intended to provide faster or better tissue integration into the sling material.
  • the present invention relates to a new sling which reduces the overall difficulty in tension adjustment by providing the patient with a more normal and physiological support.
  • the material from which the sling is made is elastic in contrast to other synthetic materials previously used. This elasticity approximates the elasticity of surrounding tissue supporting the urethra and bladder neck complex. This elasticity is sufficient to accommodate the normal up and down movements of the urethra and bladder neck complex.
  • slings made in accordance with this invention do not overly compress the urethra. Nor do they compress the urethra abruptly and totally to cause urinary retention as is the case with slings made of non-elastic material .
  • the present invention also includes length limiting means for the elastic sling.
  • the sling inhibits the excessive decent of the bladder neck during stress conditions. This is important because, under stress, it the bladder neck can drop. If the dropping of the bladder neck is not restricted and the neck is allowed to descend too far, urine leakage can occur as a result of the hyper mobility of the bladder neck.
  • the present invention by providing an elastic sling with a length expansion limitation, reduces the undesirable side effect of urinary retention by not abruptly and completely occluding the urethra in normal bladder movements, but prevents excessive bladder neck decent to minimize urine leakage in stress situations.
  • the elasticity of the sling of the present invention provides additional benefits as well.
  • the medical literature reports that one side effect of sling procedures performed in the prior art can be urethral tissue erosion. This erosion can be the result of prolonged and tight contact of a relatively non-yielding synthetic material with the urethra.
  • the present invention by providing a sling made of an elastic material which more closely approximates the surrounding tissue's softness, reduces the amount of injury to the urethra as well as possible chronic nerve compression damages as compared to the stiffer and non-yielding materials used in the prior art.
  • elastic or stretchable anchoring sutures can be used to achieve these same advantages.
  • Figure 1 is a top view of a sling made in accordance with the present invention.
  • Figure 2 is a cross-sectional view through line 2-2 in Figure 1.
  • Figure 3 is a top view of a second embodiment of a sling made in accordance with the present invention.
  • Figure 4 is a cross-sectional view through line 4-4 in Figure 3.
  • Figure 5 is a top view of a third embodiment of a sling made in accordance with the present invention.
  • Figure 6 is a cross-sectional view through line 6-6 in Figure 5.
  • Figure 7 is a top view of a sling made in accordance with a fourth embodiment of the present invention.
  • Figure 8 is a cross-sectional view through line 8-8 in Figure 7.
  • Figure 9 is a top view of a sling made in accordance with a fifth embodiment of the present invention.
  • Figure 10 is a cross-sectional view through line 10- 10 in Figure 9.
  • Figure 11 is a top view of a sling made in accordance with a sixth embodiment of the present invention.
  • Figure 12 is a cross-sectional view through line 12-12 in Figure 11.
  • Figure 13 is a plan view showing elastic sutures secured to a suture anchor.
  • the drawings show six different embodiments of the invention.
  • Each embodiment includes a support 1 and a pair of suture anchors 2 and 3.
  • the first four embodiments also include a pair of relief holes 4 and 5, and at least four sutures 6, 7, 8 and 9 where suture 6 and 7 can be contiguous, and suture 8 and 9 can be contiguous.
  • the support 1 is preferably made of a synthetic biocompatible, elastic material. The elasticity of the material should approximate that of the tissue normally surrounding the urethra. One such material is silicone. When silicone is used, the support 1 will generally be non-porous and no tissue integration into the support 1 will occur. Alternately, the support 1 can be made of a woven or porous material to promote tissue integration into the support 1.
  • the support 1 can also be coated to inhibit infection or inflammation or to promote tissue repair, tissue growth, and lubricity.
  • the support 1 can have a generally rectangular shape as shown in Figures 5 and 7. To provide for better distribution of tension to the urethra, to minimize tissue damage, and to minimize erosion, the support 1 can also have an oval shape as shown in Figures 1 and 3.
  • the suture anchors 2 and 3 serve to reinforce the ends of the support 1.
  • the suture anchors 2 and 3 also improve suture attachment to the support 1.
  • the suture anchors 2 and 3 also provide more even distribution of pull force to the support 1 as it supports the urethra.
  • the relief holes 4 and 5 are provided to increase the overall stretchability or elasticity of the support 1.
  • the relief holes may not be needed if the material from which support 1 is made sufficiently elastic.
  • the size and the number of relief holes can be modified to adjust the stretchability or elasticity of the support 1.
  • the sutures 6-9 are used to fix the sling to the abdominal tissue, pubis symphysis or any other suitable tissue or support to anchor the sling in place.
  • a shorter support 1 can be combined with longer sutures extending from the ends of the support 1 to provide the surgeon with more options for securing the sling in place.
  • FIGS. 3-4 and 7-8 include additional structures for limiting the overall elastibility of the sling.
  • these embodiments include a flexible, stretchable sheath 10 extending laterally across and secured to the underside of the support 1.
  • the sheath 10 is both thin and very elastic as compared to the support 1.
  • Encased within the sheath 10 is a monofilament string 11, the opposite ends of which are secured to the suture anchors 2 and 3.
  • the monofilament string 11 is "pre-coiled" by a heat-set operation. In this configuration, the monofilament string serves as a brake to limit how much the sling can stretch. As the sling stretches, the monofilament string 11 uncoils.
  • the sling can stretch no further.
  • the sheath 10 is placed on the underside of the support 1 away from the urethra so it does not irritate the urethra.
  • the sheath 10 can be made of silicone or some other elastomeric material which prevents tissue ingrowth that could interfere with the coiling or uncoiling of the string 11.
  • the string 11 could be embedded in the material from which support 1 is made so that the sheath 10 is integral with the support 1.
  • the present invention is used to treat urinary incontinence by supporting the urethra and neck of the bladder.
  • the device is surgically implanted so that the support 1 is beneath and in contact with the area to be supported.
  • the surgeon sutures the device to abdominal tissue, pubis symphysis, other tissue or support suitable to fix the sling in place.
  • the sling when so positioned, flexibly supports the urethra and neck of the urethra. Sufficient support is provided to inhibit unintended discharge of urine. Yet, there is sufficient elasticity so that prolonged urinary retention is not a problem and the bladder can be voided at the approximate time.

Abstract

L'invention concerne une sangle destinée à soutenir l'urètre et le col vésical pour prévenir l'incontinence d'urine. La sangle est destinée à fournir un soutien suffisant pour arrêter le flot incontrôlé d'urine mais s'étirer de façon contrôlée pour que la vessie puisse être vidée à temps.
PCT/US1999/017474 1998-08-13 1999-08-02 Sangle pour la vessie WO2000009039A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP99945008A EP1065992A4 (fr) 1998-08-13 1999-08-02 Sangle pour la vessie

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US09/133,596 1998-08-13
US09/133,596 US6042536A (en) 1998-08-13 1998-08-13 Bladder sling
US09/274,619 US6110101A (en) 1998-08-13 1999-03-23 Bladder sling
US09/274,619 1999-03-23

Publications (1)

Publication Number Publication Date
WO2000009039A1 true WO2000009039A1 (fr) 2000-02-24

Family

ID=26831506

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/017474 WO2000009039A1 (fr) 1998-08-13 1999-08-02 Sangle pour la vessie

Country Status (2)

Country Link
EP (1) EP1065992A4 (fr)
WO (1) WO2000009039A1 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE20204669U1 (de) * 2002-03-23 2003-08-07 Aesculap Ag & Co Kg Inkontinenzband zur Behandlung der Harninkontinenz
WO2004091442A3 (fr) * 2003-03-28 2005-04-21 Analytic Biosurgical Solution Implant pour le traitement de la rectocele et dispositif pour la mise en place de cet implant
DE102005021893A1 (de) * 2005-05-04 2006-11-09 Aesculap Ag & Co. Kg Vorrichtung zur Vermeidung der Harninkontinenz beim Menschen
US7351196B2 (en) 2001-08-03 2008-04-01 Aesculap Ag & Co. Kg Incontinence strip for treating urinary incontinence
US7766926B2 (en) 2002-04-30 2010-08-03 Vance Products Incorporated Sling for supporting tissue
US9144483B2 (en) 2006-01-13 2015-09-29 Boston Scientific Scimed, Inc. Placing fixation devices
US9168120B2 (en) 2011-09-09 2015-10-27 Boston Scientific Scimed, Inc. Medical device and methods of delivering the medical device
US9339362B2 (en) 2005-09-28 2016-05-17 Boston Scientific Scimed, Inc. Apparatus and method for suspending a uterus
US9387061B2 (en) 2010-09-02 2016-07-12 Boston Scientific Scimed, Inc. Pelvic implants and methods of implanting the same
US9814555B2 (en) 2013-03-12 2017-11-14 Boston Scientific Scimed, Inc. Medical device for pelvic floor repair and method of delivering the medical device
CN111388032A (zh) * 2020-03-19 2020-07-10 郑州大学第一附属医院 用于内窥镜手术的脏器悬吊装置
US11744726B2 (en) 2013-08-01 2023-09-05 Cook Medical Technologies Llc Tissue adjustment implant

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4920986A (en) * 1986-10-14 1990-05-01 Zedlani Pty. Limited Urinary incontinence device
US5362294A (en) * 1992-09-25 1994-11-08 Seitzinger Michael R Sling for positioning internal organ during laparoscopic surgery and method of use
US5386836A (en) * 1986-10-14 1995-02-07 Zedlani Pty Limited Urinary incontinence device
US5562689A (en) * 1993-08-20 1996-10-08 United States Surgical Corporation Apparatus and method for applying and adjusting an anchoring device
US5785640A (en) * 1996-05-23 1998-07-28 Kresch; Arnold J. Method for treating female incontinence
US5840011A (en) * 1995-11-17 1998-11-24 Ethicon, Inc. Implant for suspension of the urinary bladder in cases of incontinence of urine in women

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5368602A (en) * 1993-02-11 1994-11-29 De La Torre; Roger A. Surgical mesh with semi-rigid border members
JP2001511685A (ja) * 1997-02-13 2001-08-14 ボストン サイエンティフィック リミテッド 低侵襲骨盤手術で使用するための安定化スリング

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4920986A (en) * 1986-10-14 1990-05-01 Zedlani Pty. Limited Urinary incontinence device
US5386836A (en) * 1986-10-14 1995-02-07 Zedlani Pty Limited Urinary incontinence device
US5362294A (en) * 1992-09-25 1994-11-08 Seitzinger Michael R Sling for positioning internal organ during laparoscopic surgery and method of use
US5562689A (en) * 1993-08-20 1996-10-08 United States Surgical Corporation Apparatus and method for applying and adjusting an anchoring device
US5840011A (en) * 1995-11-17 1998-11-24 Ethicon, Inc. Implant for suspension of the urinary bladder in cases of incontinence of urine in women
US5785640A (en) * 1996-05-23 1998-07-28 Kresch; Arnold J. Method for treating female incontinence

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1065992A4 *

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7351196B2 (en) 2001-08-03 2008-04-01 Aesculap Ag & Co. Kg Incontinence strip for treating urinary incontinence
DE20204669U1 (de) * 2002-03-23 2003-08-07 Aesculap Ag & Co Kg Inkontinenzband zur Behandlung der Harninkontinenz
US7766926B2 (en) 2002-04-30 2010-08-03 Vance Products Incorporated Sling for supporting tissue
WO2004091442A3 (fr) * 2003-03-28 2005-04-21 Analytic Biosurgical Solution Implant pour le traitement de la rectocele et dispositif pour la mise en place de cet implant
DE102005021893A1 (de) * 2005-05-04 2006-11-09 Aesculap Ag & Co. Kg Vorrichtung zur Vermeidung der Harninkontinenz beim Menschen
US9339362B2 (en) 2005-09-28 2016-05-17 Boston Scientific Scimed, Inc. Apparatus and method for suspending a uterus
US9144483B2 (en) 2006-01-13 2015-09-29 Boston Scientific Scimed, Inc. Placing fixation devices
US9387061B2 (en) 2010-09-02 2016-07-12 Boston Scientific Scimed, Inc. Pelvic implants and methods of implanting the same
US9168120B2 (en) 2011-09-09 2015-10-27 Boston Scientific Scimed, Inc. Medical device and methods of delivering the medical device
US9814555B2 (en) 2013-03-12 2017-11-14 Boston Scientific Scimed, Inc. Medical device for pelvic floor repair and method of delivering the medical device
US11744726B2 (en) 2013-08-01 2023-09-05 Cook Medical Technologies Llc Tissue adjustment implant
CN111388032A (zh) * 2020-03-19 2020-07-10 郑州大学第一附属医院 用于内窥镜手术的脏器悬吊装置

Also Published As

Publication number Publication date
EP1065992A4 (fr) 2003-08-06
EP1065992A1 (fr) 2001-01-10

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