WO2006064063A1 - Nouvelle prothese medicale et applications associees pour le traitement de l'incontinence urinaire d'effort - Google Patents

Nouvelle prothese medicale et applications associees pour le traitement de l'incontinence urinaire d'effort Download PDF

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Publication number
WO2006064063A1
WO2006064063A1 PCT/ES2004/070108 ES2004070108W WO2006064063A1 WO 2006064063 A1 WO2006064063 A1 WO 2006064063A1 ES 2004070108 W ES2004070108 W ES 2004070108W WO 2006064063 A1 WO2006064063 A1 WO 2006064063A1
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WO
WIPO (PCT)
Prior art keywords
prosthesis
urethra
bag
area
pressure
Prior art date
Application number
PCT/ES2004/070108
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English (en)
Spanish (es)
Inventor
Jorge Valle Gerhold
Agustin Camon Lasheras
Original Assignee
Consejo Superior De Investigaciones Científicas
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 Consejo Superior De Investigaciones Científicas filed Critical Consejo Superior De Investigaciones Científicas
Publication of WO2006064063A1 publication Critical patent/WO2006064063A1/fr

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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
    • A61F2/0045—Support slings
    • 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
    • A61F2/0022—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening

Definitions

  • the treatment by surgery aims in various ways to fix the bladder to the bony or ligamentous structures of the neighborhood to prevent it from moving during efforts.
  • transvaginal techniques are mostly used, that is, through incisions in the vagina and laparoscopic, that is, through tubes that pierce the skin of the abdomen.
  • TVT tension free transvaginal tape
  • GYNECARE TVT Pat n ° 6,641,524
  • It is a mesh tape of inert material that suspends the urethra as if it were a sling, leaving the free ends of the tape in the subcutaneous fat above the pubis.
  • the same system has been used for decades for severe incontinence with the removal of a tape of aponeurosis as a graft of the patient.
  • These sling systems produce a tensionless cerclage of the bladder neck, preventing its displacement during coughing.
  • sphincter is the so-called Karran prosthesis (US Patent 6,095,969 (2000)). It is a device with a serum bag that is deposited in the abdomen by laparoscopy and is joined by a rubber tube, interrupted by a valve, which joins it to a rectangular pad that is sutured on the abdominal face of the urethra to transmit to this the changes in abdominal pressure detected by the bag.
  • Karran prosthesis US Patent 6,095,969 (2000). It is a device with a serum bag that is deposited in the abdomen by laparoscopy and is joined by a rubber tube, interrupted by a valve, which joins it to a rectangular pad that is sutured on the abdominal face of the urethra to transmit to this the changes in abdominal pressure detected by the bag.
  • An object of the present invention is a medical prosthesis for surgical implantation in humans, preferably in women, hereinafter prostheses of the invention, useful for the treatment of stress urinary incontinence, and which is constituted by a closed bag or balloon as a single piece filled with serum, without air inside, similar in shape and size to a pure and deformable as the serum is not under pressure. It is placed from a vaginal incision to be lodged in the tissue that surrounds the urethra as a loop, with the ends inside the preperitoneal abdominal cavity or Retzius space. Being a single piece with liquid inside, it has the property of distributing equally and instantaneously the variations of the hydrostatic pressure that occur at each point of the device.
  • Another object of the present invention is the use of the prosthesis of the present invention in the treatment of female stress incontinence.
  • the advantage of the prosthesis of the invention is that it works automatically, without the patient having to manipulate the device every time she wants to urinate, as is the case with existing prostheses.
  • the prosthesis only presses the urethra for the duration of the increase in pressure in the abdomen, avoiding the discomfort generated by devices that permanently press the urethra.
  • the prosthesis has a great simplicity and reliability in its manufacture and its implantation is possible with a single incision in the vagina and in 30 minutes, allowing hospital discharge in a few hours after it.
  • the present invention is based on the fact that the inventors have observed that stress urinary incontinence can be avoided by means of a specially designed medical prosthesis and object of this patent, based on the fact that said prosthesis facilitates a maximum hydrostatic and instantaneous transmission of the Abdominal pressure changes to the urethra.
  • this prosthesis is simple to manufacture and install, low cost and maintenance free. Increases in abdominal pressure during cough, laughter, etc. They directly affect the prosthesis, especially in the free areas inside the abdomen, but also in the anterior area of the urethra and bladder neck, distributing the pressure through the rest of the urethra to collapse preventing urine leakage.
  • an object of the present invention is a medical prosthesis for surgical implantation in humans, preferably in women, hereinafter prostheses of the invention, which allows a hydrostatic transmission to the sphincter of abdominal pressure changes, useful for the treatment of urinary stress incontinence, and that is constituted by a bag or balloon as a single piece characterized by:
  • Said bag is a closed bag or balloon as a single piece filled with serum, without air inside, similar in shape and size to a pure and deformable as the serum is not tensioned.
  • Said bag has great malleability, such as a surgical glove, - it is constructed of a biocompatible material, derived from silicone, and because it incorporates, included in its own wall, three areas of reinforcement that increase the resistance of the bag:
  • the dimensions correspond, when the bag is full, to those of a cylinder with a diameter between 5 and 20 millimeters and a length between 8 and 30 centimeters. The variation of the dimensions allows the ideal application to each patient according to their size.
  • the areas of reinforcement which increase the resistance, are constituted by appliques of fabric mesh included in the silicone wall itself.
  • the portion of the bag that surrounds the urethra once surgically implanted, has a very soft internal face that facilitates its deformity depending on its greater or lesser filling and another outer face of greater hardness by having added a layer of tissue mesh encompassed in the silicone so that it does not deform with pressure changes.
  • the prosthesis Once the prosthesis is implanted, it will surround the urethra in a loop, leaving the two ends of said loop free inside the abdominal cavity, at the level of the so-called Retzius space ( Figure 2).
  • the closure of the loop is achieved by placing one or several stitches, joining the inner portions of the bag in the place where two of the mesh sconces have been placed.
  • the other mesh sconce comprises the entire outer perimeter of the part of the prosthesis that surrounds the urethra and is intended to prevent distention to the outside during pressure peaks, which will thus fall entirely inside the loop, that is, on the urethra (Figure 1, RP).
  • the loop is not distensible in the outer diameter and if it is inside.
  • the scar reaction that will involve the prosthesis in the weeks following its placement contributes to keeping the urethra and bladder neck inside the abdominal cavity, even during increases in pressure.
  • the bladder detrusor muscle is contracted to increase intravesical pressure without affecting abdominal pressure while relaxing the striated sphincter, without interference from the prosthesis and therefore without requiring intervention of any kind by The patient on the prosthesis.
  • the fixation exerted by the device is similar to classic interventions or TVT, but pressure transmission is added to the tissues surrounding the bladder neck and urethra throughout its circumference, even when over the years Change the patient's anatomy, the cause of most of the failures of conventional techniques.
  • Another object of the present invention is the use of the prosthesis of the present invention in the treatment of female stress incontinence.
  • the prosthesis of the present invention has technical characteristics that, after a specific surgical intervention for implantation in the human body, allow an effective control of urinary incontinence of the effort or stress type in women, which on the other hand are the most.
  • the advantage of the prosthesis of the invention is that it works automatically, without the patient having to manipulate the device every time he wants to urinate, just as other existing prostheses occur.
  • the prosthesis only presses the urethra for a very short time, avoiding the discomfort and complications generated by devices that permanently press the urethra.
  • the prosthesis has a great simplicity and reliability in its manufacture, and its implantation is possible with a single incision in the vagina and in 30 minutes.
  • Figure 1 Prosthesis, extended general view, where its different areas and reinforcements are defined.
  • AE outside area.
  • RP wall reinforcement.
  • RS suture reinforcement.
  • AIPU interior periurethral area.
  • Figure 2 Prosthesis, general view in the form of a loop as it will be after its surgical implantation.
  • AE outside area.
  • AI interior area AI interior area.
  • RP wall reinforcement.
  • RS suture reinforcement.
  • AIPU interior periurethral area.
  • S stitch.
  • Figure 3 Prototype of artificial abdomen.
  • Figure 7 Surgical view of the vagina, eyelets of the fascia on the sides of the urethra.
  • Figure 8 Surgical view of the vagina, a dissector that crosses from one eye to the other over the urethra. The dissector has entered the abdominal cavity on the anterior aspect of the urethra and after surrounding it manages to go outside again. This will be the path that will house the prosthesis.
  • Figure 9 Surgical view of the vagina, a dissector that crosses from one eye to the other over the urethra to catch one end of the prosthesis from which to pull so that it is placed around the urethra.
  • Figure 10 Surgical view of the prosthesis surrounding the urethra before closing the loop. Being a very malleable device it is possible to fix the points from the outside, with great ease, adjusting them to the anatomy of each patient to later introduce the ends inside the abdominal cavity through the open eyelets in the endopelvic fascia.
  • Figure 11 Surgical view of the prosthesis with the closure of the loop concluded.
  • Figure 12 Surgical view of the vagina, definitive situation with the ends of the loop inside the abdomen. To introduce them, it is enough to push with the help of tweezers, gradually the ends of the device while rotating the portion of the prosthesis surrounding the urethra.
  • Figure 13 Anatomical image where the definitive location of the prosthesis is recreated in relation to the bladder, pelvic bones and uterus.
  • the purpose of the simulation complex described is to confirm that there is no delay in the transmission of pressures due to the materials used, so that the occlusion of the urethra is synchronous with the moment of incontinence, arriving in time to avoid it, as well as to establish the measures of the prosthesis that are suitable for said occlusion.
  • Example 2. Surgical implantation of the prosthesis of the present invention.
  • the prosthesis Before implantation, the prosthesis has an elongated shape as an easily deformable tube or bar.
  • said bag is a bag or balloon completely closed, elongated, like a surgeon's glove finger filled with physiological serum, said bag has great malleability as it is not completely filled with serum, without air inside, it is constructed of a material biocompatible, silicone derivative, and because it incorporates, included in its own wall, three areas of reinforcement that increase the resistance of the bag:
  • the prosthetic bag of the present invention does not contain air or other gaseous element, so that the filling volume thereof does not become complete to guarantee the deformity of the assembly and allows the movement of the serum of inside the bag according to the forces that act in each area of the prosthesis. In this way the bag is compressible but not distensible from a maximum. It should be noted that if the bag were completely filled it would not be easy to mold the prosthesis on the structures on which it rests. By way of example, it can be filled by hand, Squeeze a little to completely purge the air and then heat seal. If necessary, and as in the manufacture of other similar prostheses, a thicker wall area is left where the interior can be punctured to fill, empty or purge the air.
  • the dimensions correspond, when the bag is full, to those of a cylinder with a diameter between 5 and 20 millimeters and a length between 8 and 30 centimeters.
  • the variation of the dimensions allows the ideal application to each patient according to their size.
  • the areas of reinforcement which increase the resistance, are constituted by appliques of fabric mesh included in the silicone wall itself.
  • the mesh is part of the material since it is injected into the mold during its manufacture.
  • the prosthesis of the present invention is placed in a patient making an inverted "U” incision in the anterior wall of the vagina, below the urethral meatus, which exposes the urethra and on its sides some membranes called endopelvic fascia.
  • a buttonhole of several millimeters on each side of the urethra the fatty tissue inside the abdomen is accessed ( Figure 7).
  • a curved instrument it is possible to enter through one buttonhole and exit through the other, thus surrounding the urethra in its intra-abdominal portion and surrounding tissues without damaging them.
  • the portion of the bag surrounding the urethra once surgically implanted and due to the technical characteristics of the prosthesis itself of the present invention, has a very soft internal face that facilitates its deformity depending on its greater or lesser filling. of serum and another external face of greater hardness when having added a layer of mesh of tissue encompassed in the silicone so that it does not deform during the pressure peaks, and that in this way they will fall entirely inside the loop, that is, on the urethra
  • the loop is not distensible in the outer diameter and if it is inside.
  • the two suture reinforcements can be contacted through the midline, so that if they are joined with a suture point, the prosthesis will form a loop ( Figure 2).
  • the prosthesis Once the prosthesis is implanted, it will surround the urethra and surrounding tissues in a loop, leaving the two ends of said loop free inside the abdominal cavity, at the level of the so-called Retzius space ( Figure 2).
  • the prosthesis is placed inside the patient without direct access to it. It is not necessary to activate anything to make it work, since its effect is achieved entirely passively. Thus, during a baseline rest situation nothing happens when the pressures are balanced.
  • the scar reaction that will involve the prosthesis helps keep the urethra and bladder neck inside the abdominal cavity, even during increases in pressure to the hinder the sliding of the urethra to the outside of the abdomen, which can adequately receive such increases in pressure as well as the bladder, so that the urethra can collapse thus contributing to a more effective continence.
  • the fixation that this prosthesis exerts is similar to the classic surgical interventions or to the TVT, but the facilitation for the transmission of pressure in the entire circumference of the urethra is added, even when the anatomy of the patient changes over the years, cause of most of the failures of conventional techniques.
  • the bladder detrusor muscle contracts while the muscular sphincter relaxes, without interference from the prosthesis.
  • the advantage of the prosthesis of the invention is that it works automatically, without the patient having to manipulate the device every time he wants to urinate, as is the case with existing prostheses.
  • the prosthesis only presses the urethra for a very short time, avoiding the discomfort generated by devices that permanently press the urethra.
  • the prosthesis presents a great simplicity and reliability is its manufacture and its implantation is possible with a single incision in the vagina and in 30 minutes.

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

L'invention concerne une prothèse médicale destinée à être implantée par intervention chirurgicale chez des patients humains, de préférence chez des sujets de sexe féminin souffrant d'incontinence urinaire d'effort. Le dispositif de l'invention est constitué par une poche de sérum positionnée autour de l'urètre, dont les extrémités sont placées à l'intérieur de la cavité abdominale. Lorsque la pression augmente dans l'abdomen, par exemple à cause d'une quinte de toux, ladite pression se répercute sur l'urètre, refermant celui-ci et empêchant ainsi un écoulement d'urine. L'avantage présenté par ladite prothèse réside en ce que celle-ci fonctionne automatiquement, sans que la patiente n'ait à manipuler le dispositif pour uriner. En outre, ladite prothèse ne comprime l'urètre que pendant quelques secondes, ce qui permet d'éviter les problèmes causés par les dispositifs qui compriment l'urètre en permanence. La prothèse de l'invention est simple d'utilisation et hautement fiable, et peut être implantée au moyen d'une seule incision vaginale, en 30 minutes, de sorte que la patiente puisse quitter l'hôpital après quelques heures.
PCT/ES2004/070108 2003-12-17 2004-12-14 Nouvelle prothese medicale et applications associees pour le traitement de l'incontinence urinaire d'effort WO2006064063A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES200302987A ES2237321B1 (es) 2003-12-17 2003-12-17 Nueva protesis medica y sus aplicaciones para el tratamiento de la incontinencia urinaria de esfuerzo.
ESP200302987 2003-12-17

Publications (1)

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WO2006064063A1 true WO2006064063A1 (fr) 2006-06-22

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PCT/ES2004/070108 WO2006064063A1 (fr) 2003-12-17 2004-12-14 Nouvelle prothese medicale et applications associees pour le traitement de l'incontinence urinaire d'effort

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ES (1) ES2237321B1 (fr)
WO (1) WO2006064063A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0248544A1 (fr) * 1986-05-07 1987-12-09 National Research Development Corporation Prothèse d'incontinence urinaire
US5090424A (en) * 1990-12-31 1992-02-25 Uromed Corporation Conformable urethral plug
FR2698781A1 (fr) * 1992-12-07 1994-06-10 Chanez Jean Francois Dispositif destiné à remédier aux incontinences urinaires légères chez la femme.

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0248544A1 (fr) * 1986-05-07 1987-12-09 National Research Development Corporation Prothèse d'incontinence urinaire
US5090424A (en) * 1990-12-31 1992-02-25 Uromed Corporation Conformable urethral plug
FR2698781A1 (fr) * 1992-12-07 1994-06-10 Chanez Jean Francois Dispositif destiné à remédier aux incontinences urinaires légères chez la femme.

Also Published As

Publication number Publication date
ES2237321A1 (es) 2005-07-16
ES2237321B1 (es) 2006-10-16

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