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WO1998031301A1 - Dispositif de maitrise de l'incontinence urinaire d'effort reelle chez la femme - Google Patents

Dispositif de maitrise de l'incontinence urinaire d'effort reelle chez la femme Download PDF

Info

Publication number
WO1998031301A1
WO1998031301A1 PCT/IB1997/000670 IB9700670W WO9831301A1 WO 1998031301 A1 WO1998031301 A1 WO 1998031301A1 IB 9700670 W IB9700670 W IB 9700670W WO 9831301 A1 WO9831301 A1 WO 9831301A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
periurethral
cuff
bladder neck
periurethral cuff
Prior art date
Application number
PCT/IB1997/000670
Other languages
English (en)
Inventor
Shantha Jayatilake Bandara Lenadora
Welatantrige Devika Kamalinie Lenadora
Original Assignee
Lenadora Shantha Jayatilake Ba
Lenadora Welatantrige Devika K
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 GB9700770A external-priority patent/GB2309388A/en
Application filed by Lenadora Shantha Jayatilake Ba, Lenadora Welatantrige Devika K filed Critical Lenadora Shantha Jayatilake Ba
Priority to AU29127/97A priority Critical patent/AU2912797A/en
Publication of WO1998031301A1 publication Critical patent/WO1998031301A1/fr

Links

Classifications

    • 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
    • A61F2/004Closure 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 inflatable

Definitions

  • This device relates to an implant for the treatment of genuine stress urinary incontinence in the female.
  • Stress incontinence is urine loss that occurs when sudden increase in intra-abdominal pressure force urine past the urethral sphincter mechanism. This usually occurs during conditions of physical activity which stress the bladder outlet to such a degree that it can no longer remain closed, resulting a momentary urine loss. This is a common and distressing condition.
  • This implantable continence device consists of a hydraulic and a mechanical component.
  • the hydraulic component comprises of two retropubic subperitoneal fluid filled balloon reservoirs 1 which communicates with a periurethral cuff 2 to form a complete hydraulic system.
  • a fluid outlet channel 4 At the upper end of the periurethral cuff 2 there is a fluid outlet channel 4 to regulate the biocompatible fluid in the hydraulic system.
  • the mechanical component comprises of two strips of biocompatible mesh extending sideways from the base of the periurethral cuff 2 to form two wings 3. Both wings are transfixed to pelvic fascia and white line of the pelvis using non absorbable material.
  • the base of the periurethral cuff 2 and the necks of the balloon reservoirs are reinforced to achieve non kink properties. Both components are made of suitable biocompatible material and the hydraulic system is filled with biocompatible fluid.
  • FIG 1 Shows the basic components of the device.
  • Figure 2 Shows the basic components seen from Right side.
  • Figure 3 Shows a cross section of the device at the proximal end of the device.
  • Figure 4 Shows a sagittal section of the female pelvis with the device in situ.
  • both balloon reservoirs 1 occupy the retropubic space and extends subperitonealy beyond the upper margin of the symphysis pubis.
  • the periurethral cuff 2 surrounds the posterior and lateral aspects of the bladder neck and proximal urethra.
  • the wings 3 are transfixed to the endopelvic fascia and to the white line of the pelvis to form a platform.
  • the fluid outlet channel 4 is buried subcutaneously in the suprapubic area. The activation of the device could be done later by inserting biocompatible fluid via the fluid outlet channel 4.
  • the resting urethral pressure could also be increased to the required levels by adjusting the pressure in the hydraulic system, especially for patients who have higher grades of stress incontinence due to intrinsic sphinteric weakness.
  • the periurethral cuff 2 could be lengthened to cover distal parts of the urethra so that increased mtra-abdominal pressure is transmitted to more distal parts of the urethra. This would act as a second line of defence to prevent the escape of any urine which happens to enter the urethra.
  • the elevation of the urethra and bladder neck could be achieved by increasing the outer diameter of the periurethral cuff 2.
  • this device influences all the known mechanisms of continence by enhancing the transmission of increased intra-abdominal pressure to bladder neck and proximal urethra during stress, prevention of herniation of posterior urethra and bladder neck, and improving the resting urethral pressure. Summation of these mechanisms could ultimately increase the patient's margin for incontinence and push her above the threshold for urinary leakage. The contribution from each component of the device to gain continence could be determined by prior urodynamic investigations. The fluid pressure of the hydraulic system could be readjusted periodically to maintain the optimal resting urethral pressure. The implant could be used as a primary treatment or as a secondary procedure following unsuccessful primary surgery.

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)

Abstract

Ce dispositif implantable de maîtrise de l'incontinence est constitué de deux composants, hydraulique et mécanique. Le composant hydraulique comporte deux réservoirs à ballonnet rétropubiens sous-péritonéaux remplis de fluide (1) en communication avec un manchon péri-urétéral (2) afin de constituer un système hydraulique complet. Sur l'extrémité supérieure du manchon péri-urétéral (2) se trouve un canal de sortie de fluide (4) destiné à la régulation du fluide biocompatible dans le système hydraulique. Le composant mécanique comprend deux bandes de mailles biocompatibles partant latéralement de la base du manchon péri-urétéral (2) pour former deux ailes (3). Ces deux ailes sont ancrées à l'aponévrose pelvienne et à la ligne de Hunter par le biais d'un matériau non absorbable. La base du manchon péri-urétéral (2) et les cols des réservoirs à ballonnet sont renforcés afin d'éviter tout entortillement. Ces deux composants sont fabriqués avec un matériau biocompatible approprié et le système hydraulique est rempli d'un fluide biocompatible. Ce dispositif, qui améliore le profil de la pression urétérale au repos comme en situation d'effort, prévient la protrusion herniaire du col vésical et de la partie proximale de l'urètre lorsque la pression intra-abdominale s'accroît.
PCT/IB1997/000670 1997-01-15 1997-06-10 Dispositif de maitrise de l'incontinence urinaire d'effort reelle chez la femme WO1998031301A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU29127/97A AU2912797A (en) 1997-01-15 1997-06-10 Device for genuine stress incontinence in the female

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9700770A GB2309388A (en) 1996-01-24 1997-01-15 Implantable device for incontinence relief in the female
GB9700770.2 1997-01-15

Publications (1)

Publication Number Publication Date
WO1998031301A1 true WO1998031301A1 (fr) 1998-07-23

Family

ID=10806034

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB1997/000670 WO1998031301A1 (fr) 1997-01-15 1997-06-10 Dispositif de maitrise de l'incontinence urinaire d'effort reelle chez la femme

Country Status (2)

Country Link
AU (1) AU2912797A (fr)
WO (1) WO1998031301A1 (fr)

Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2787990A1 (fr) * 1998-12-30 2000-07-07 Medical Research & Management Prothese destinee a corriger l'incontinence urinaire chez la femme
DE10156558A1 (de) * 2001-11-20 2003-05-28 Helmut Wassermann Verschlusssystem und ein Verfahren hierzu
EP1354568A2 (fr) * 2002-04-17 2003-10-22 Centre Hospitalier Universitaire de Rouen Dispositif de traitement de l'incontinence urinaire
US6908425B2 (en) 1999-06-09 2005-06-21 Ethicon Inc. Surgical instrument and method for treating female urinary incontinence
US6932759B2 (en) 1999-06-09 2005-08-23 Gene W. Kammerer Surgical instrument and method for treating female urinary incontinence
US7025063B2 (en) 2000-09-07 2006-04-11 Ams Research Corporation Coated sling material
US7083637B1 (en) 1999-06-09 2006-08-01 Tannhauser Robert J Method and apparatus for adjusting flexible areal polymer implants
US7087065B2 (en) 2001-10-04 2006-08-08 Ethicon, Inc. Mesh for pelvic floor repair
WO2006105053A2 (fr) * 2005-03-28 2006-10-05 Horndeski Gary M Dispositif et procede de controle du poids par reduction indirecte du volume de la cavite abdominale
US7131944B2 (en) 2002-03-01 2006-11-07 Ethicon, Inc. Method and apparatus for treating pelvic organ prolapses in female patients
US7131943B2 (en) 2000-03-09 2006-11-07 Ethicon, Inc. Surgical instrument and method for treating organ prolapse conditions
US7156858B2 (en) 2000-04-20 2007-01-02 Ethicon G.M.B.H. Implant
US7217237B2 (en) 2001-11-20 2007-05-15 Dieter Jocham Closing system and electronic control method
US7226407B2 (en) 1999-06-09 2007-06-05 Ethicon, Inc. Surgical instrument and method for treating female urinary incontinence
US7285086B2 (en) 2004-07-28 2007-10-23 Ethicon, Inc. Minimally invasive medical implant and insertion device and method for using the same
US7481314B2 (en) 2005-02-02 2009-01-27 Ethicon, Inc. Packaging assembly for surgical mesh implants
US7527588B2 (en) 2004-09-15 2009-05-05 Ethicon, Inc. System and method for surgical implant placement
US7658743B2 (en) 1995-10-09 2010-02-09 Ethicon, Inc. Surgical instrument and method for treating female urinary incontinence
US8123671B2 (en) 2005-08-04 2012-02-28 C.R. Bard, Inc. Pelvic implant systems and methods
US8480559B2 (en) 2006-09-13 2013-07-09 C. R. Bard, Inc. Urethral support system
US8574149B2 (en) 2007-11-13 2013-11-05 C. R. Bard, Inc. Adjustable tissue support member
US8784296B2 (en) 2010-09-07 2014-07-22 Coloplast A/S Angled surgical introducer
US8845512B2 (en) 2005-11-14 2014-09-30 C. R. Bard, Inc. Sling anchor system
WO2014178979A3 (fr) * 2013-05-03 2015-02-19 Cullison James W Implant urologique
US9289204B2 (en) 2008-12-05 2016-03-22 Boston Scientific Scimed, Inc. Insertion device and method for delivery of a mesh carrier
US9301750B2 (en) 2009-11-03 2016-04-05 Boston Scientific Scimed, Inc. Device and method for delivery of mesh-based devices
US10582923B2 (en) 2009-04-17 2020-03-10 Boston Scientific Scimed, Inc. Apparatus for delivering and anchoring implantable medical devices

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3789828A (en) * 1972-09-01 1974-02-05 Heyer Schulte Corp Urethral prosthesis
EP0207426A2 (fr) * 1985-07-05 1987-01-07 Habley Medical Technology Corporation Circuit élastofluidique pour la commande d'un sphincter
WO1988000064A1 (fr) * 1986-07-03 1988-01-14 Habley Medical Technology Corporation Prothese genito-urinaire a implantation hypodermique
US4969474A (en) * 1988-10-11 1990-11-13 Schwarz Gerald R Incontinence bladder control method and apparatus
EP0639355A1 (fr) * 1993-08-21 1995-02-22 RULL, Johann, Dr. med. Prothèse pour remédier à l'incontinence urinaire chez la femme

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3789828A (en) * 1972-09-01 1974-02-05 Heyer Schulte Corp Urethral prosthesis
EP0207426A2 (fr) * 1985-07-05 1987-01-07 Habley Medical Technology Corporation Circuit élastofluidique pour la commande d'un sphincter
WO1988000064A1 (fr) * 1986-07-03 1988-01-14 Habley Medical Technology Corporation Prothese genito-urinaire a implantation hypodermique
US4969474A (en) * 1988-10-11 1990-11-13 Schwarz Gerald R Incontinence bladder control method and apparatus
EP0639355A1 (fr) * 1993-08-21 1995-02-22 RULL, Johann, Dr. med. Prothèse pour remédier à l'incontinence urinaire chez la femme

Cited By (45)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7658743B2 (en) 1995-10-09 2010-02-09 Ethicon, Inc. Surgical instrument and method for treating female urinary incontinence
FR2787990A1 (fr) * 1998-12-30 2000-07-07 Medical Research & Management Prothese destinee a corriger l'incontinence urinaire chez la femme
US7121997B2 (en) 1999-06-09 2006-10-17 Ethicon, Inc. Surgical instrument and method for treating female urinary incontinence
US7547316B2 (en) 1999-06-09 2009-06-16 Ethicon, Inc. Method and apparatus for adjusting flexible areal polymer implants
CN100415179C (zh) * 1999-06-09 2008-09-03 伊西康公司 用于调整柔性区的聚合体植入物的外科手术器械和方法
US6908425B2 (en) 1999-06-09 2005-06-21 Ethicon Inc. Surgical instrument and method for treating female urinary incontinence
US6932759B2 (en) 1999-06-09 2005-08-23 Gene W. Kammerer Surgical instrument and method for treating female urinary incontinence
US7226407B2 (en) 1999-06-09 2007-06-05 Ethicon, Inc. Surgical instrument and method for treating female urinary incontinence
US7083637B1 (en) 1999-06-09 2006-08-01 Tannhauser Robert J Method and apparatus for adjusting flexible areal polymer implants
US7131943B2 (en) 2000-03-09 2006-11-07 Ethicon, Inc. Surgical instrument and method for treating organ prolapse conditions
US7156858B2 (en) 2000-04-20 2007-01-02 Ethicon G.M.B.H. Implant
US7025063B2 (en) 2000-09-07 2006-04-11 Ams Research Corporation Coated sling material
US8147478B2 (en) 2000-09-07 2012-04-03 Ams Research Corporation Coated sling material
US7087065B2 (en) 2001-10-04 2006-08-08 Ethicon, Inc. Mesh for pelvic floor repair
US7217237B2 (en) 2001-11-20 2007-05-15 Dieter Jocham Closing system and electronic control method
DE10156558A1 (de) * 2001-11-20 2003-05-28 Helmut Wassermann Verschlusssystem und ein Verfahren hierzu
US7131944B2 (en) 2002-03-01 2006-11-07 Ethicon, Inc. Method and apparatus for treating pelvic organ prolapses in female patients
US8480556B2 (en) 2002-03-01 2013-07-09 Ethicon, Inc. Method and apparatus for treating pelvic organ prolapses in female patients
US8460170B2 (en) 2002-03-01 2013-06-11 Ethicon, Inc. Method and apparatus for treating pelvic organ prolapses in female patients
US7985173B2 (en) 2002-03-01 2011-07-26 Ethicon, Inc. Method and apparatus for treating pelvic organ prolapses in female patients
EP1354568A2 (fr) * 2002-04-17 2003-10-22 Centre Hospitalier Universitaire de Rouen Dispositif de traitement de l'incontinence urinaire
AU2003203750B2 (en) * 2002-04-17 2004-11-11 Centre Hospitalier Universitaire De Rouen Device for the treatment of urinary incontinence
FR2838629A1 (fr) * 2002-04-17 2003-10-24 Ct Hospitalier Universitaire Rouen Dispositif de traitement de l'incontinence urinaire
EP1354568A3 (fr) * 2002-04-17 2010-10-27 Centre Hospitalier Universitaire de Rouen Dispositif de traitement de l'incontinence urinaire
US7163506B2 (en) 2002-04-17 2007-01-16 Centre Hospitalier Universitaire De Rouen Device for the treatment of urinary incontinence
US7297102B2 (en) 2004-07-28 2007-11-20 Ethicon, Inc. Minimally invasive medical implant and insertion device and method for using the same
US7285086B2 (en) 2004-07-28 2007-10-23 Ethicon, Inc. Minimally invasive medical implant and insertion device and method for using the same
US7527588B2 (en) 2004-09-15 2009-05-05 Ethicon, Inc. System and method for surgical implant placement
US7481314B2 (en) 2005-02-02 2009-01-27 Ethicon, Inc. Packaging assembly for surgical mesh implants
WO2006105053A3 (fr) * 2005-03-28 2006-11-30 Gary M Horndeski Dispositif et procede de controle du poids par reduction indirecte du volume de la cavite abdominale
WO2006105053A2 (fr) * 2005-03-28 2006-10-05 Horndeski Gary M Dispositif et procede de controle du poids par reduction indirecte du volume de la cavite abdominale
US8123671B2 (en) 2005-08-04 2012-02-28 C.R. Bard, Inc. Pelvic implant systems and methods
US8845512B2 (en) 2005-11-14 2014-09-30 C. R. Bard, Inc. Sling anchor system
US8480559B2 (en) 2006-09-13 2013-07-09 C. R. Bard, Inc. Urethral support system
US8574149B2 (en) 2007-11-13 2013-11-05 C. R. Bard, Inc. Adjustable tissue support member
US9289204B2 (en) 2008-12-05 2016-03-22 Boston Scientific Scimed, Inc. Insertion device and method for delivery of a mesh carrier
US10271937B2 (en) 2008-12-05 2019-04-30 Boston Scientific Scimed, Inc. Insertion device and method for delivery of a mesh carrier
US12021196B2 (en) 2008-12-05 2024-06-25 Boston Scientific Scimed, Inc. Insertion device and method for delivery of a mesh carrier
US10582923B2 (en) 2009-04-17 2020-03-10 Boston Scientific Scimed, Inc. Apparatus for delivering and anchoring implantable medical devices
US9301750B2 (en) 2009-11-03 2016-04-05 Boston Scientific Scimed, Inc. Device and method for delivery of mesh-based devices
US8784296B2 (en) 2010-09-07 2014-07-22 Coloplast A/S Angled surgical introducer
WO2014178979A3 (fr) * 2013-05-03 2015-02-19 Cullison James W Implant urologique
US9398942B2 (en) 2013-05-03 2016-07-26 James W Cullison Surgical implant
US10463466B2 (en) 2013-05-03 2019-11-05 James W Cullison Surgical implant
US11241302B2 (en) 2013-05-03 2022-02-08 James W Cullison Surgical method

Also Published As

Publication number Publication date
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