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WO1999001172A1 - Catether intrauretral pour controle urinaire - Google Patents

Catether intrauretral pour controle urinaire Download PDF

Info

Publication number
WO1999001172A1
WO1999001172A1 PCT/US1998/013519 US9813519W WO9901172A1 WO 1999001172 A1 WO1999001172 A1 WO 1999001172A1 US 9813519 W US9813519 W US 9813519W WO 9901172 A1 WO9901172 A1 WO 9901172A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve body
balloon
valve
generally
urinary control
Prior art date
Application number
PCT/US1998/013519
Other languages
English (en)
Inventor
Fouad Salama
Original Assignee
Opticon Medical 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
Application filed by Opticon Medical Inc. filed Critical Opticon Medical Inc.
Priority to AU81764/98A priority Critical patent/AU8176498A/en
Publication of WO1999001172A1 publication Critical patent/WO1999001172A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0017Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10184Means for controlling or monitoring inflation or deflation
    • A61M25/10185Valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M25/0075Valve means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10181Means for forcing inflation fluid into the balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1078Urinary tract
    • A61M2210/1089Urethra
    • A61M2210/1096Male

Definitions

  • the present invention relates generally to catheters and, more specifically, to a balloon-
  • Intraurethral urinary catheters for evacuating the bladder are known, including those
  • Foley catheters which typically include a balloon at one end. After a Foley-type
  • indwelling also may be referred to as indwelling or self-retaining.
  • a urine tube extends through a
  • a control valve is located along the urine tube for controlling the flow of urine.
  • An inflation tube extends along the length of the urine tube into the balloon, and has an inlet end for receiving inflation fluid for inflating the balloon. The inlet end is normally closed except when opened by a blunt needle for
  • U.S. Patent 5,188,607 discloses a valve catheter connector assembly including a resilient sleeve which acts as the hub of the catheter for receiving the male connector tube while sealing the catheter tube against retrograde blood flow until the male connector is fully inserted.
  • a blunt cannula and a septum with a pre-perf orated slit including a blunt cannula and a septum with a pre-perf orated slit.
  • the Mollenauer et al. self-sealing valve comprises an elastomeric
  • the Banaldo medical valve includes an elastomeric self- sealing valve element which may be pierced by an external needle to insert a catheter.
  • the Banaldo valve element may be pre-slit and opened by an internal insert.
  • a self-sealing valve could be integrated with an intraurethral urinary control catheter such as those disclosed in the Salama patents, particularly with the
  • sealing microvalve for enabling and facilitating the use of a blunt needle or cannula for filling and emptying the balloon.
  • the microvalve enables the needle or cannula to enter the inflation
  • the valve will accommodate needles or cannulae of various sizes.
  • the microvalve of the present invention includes a precut slit through which a blunt needle (e.g., a 23 gauge needle) can pass in order to fill and empty the balloon. Prior to this
  • the inflation tube (of the typical catheter, e.g., a Foley catheter) was large and bulky,
  • the microvalve is friction fit in the valve housing, i.e., the inflation tube, and requires no adhesive to hold it in place in the
  • the catheter of the present invention is an intraurethral, balloon-type urinary control
  • catheter including an elongated generally cylindrical catheter body with a urine tube having an
  • An inflation tube operably coupled to a balloon generally adjacent to one end of the inflation tube and the inlet opening.
  • valve the microvalve of the present invention
  • the microvalve of the present invention is adjacent to the other end of the inflation tube, and comprises a generally cylindrical, solid valve body formed substantially of compressible, resilient elastomeric material.
  • the valve body has two flat ends, a needle guide being
  • valve body is substantially split into two generally hemispheric portions. It is received in a housing
  • body portions each have a facing surface and the force exerted by the inflation tube housing-
  • the catheter of the present invention is intended for use in the clinical and hospital
  • catheter and microvalve of the present invention is increased comfort during use and ease of use (including inflation and deflation of the
  • a blunt or dull needle or cannula may be used to fill and empty the
  • catheter of the present invention is much less bulky than the typical catheter, less irritating for the user, and includes a microvalve with a needle guide and centering opening at one end.
  • Figure 1 is an elevational view of one embodiment of the catheter with the microvalve of
  • Figure 2 is an elevational view of another embodiment of the catheter of the present
  • Figure 3 is an elevational view, in cross-section, of the microvalve of the present invention.
  • Figure 4 is a cross-sectional view taken along lines 4-4 of Figure 3.
  • Figure 5 is a cross-section taken along line 5-5 of Figure 1.
  • microvalve 12 of the present invention including the microvalve 12 of the present invention.
  • Such fastening means and methods include adhesives, friction fitting, chemical and sonic welding, heating, deformation and the like.
  • materials for making the components of the present invention are selected from appropriate synthetic and natural elastomeric materials such as silicone, latex, silastic and the like, and appropriate forming methods including casting, dipping,
  • Figures 1 and 2 depict two embodiments of the catheter 10 of the present invention incorporating an inflation/deflation controlling microvalve 12.
  • catheters 10 have a generally cylindrical body including a urine tube 14 with at least one inlet 16 adjacent to one end of the catheter to receive urine while the catheter is in place in the bladder.
  • a fill or inflation tube 18 extends generally along or parallel to the urine tube 14.
  • An inflatable balloon 20 (shown in phantom in Figure 2) is generally adjacent to or at one end of the inflation
  • the inflation tube 18 has an inlet end 24 adapted to receive the delivery end of a filling device such as a syringe or pump device containing liquid or
  • the inflation tube 18 includes a microvalve housing region 26 adjacent
  • the microvalve housing region 26 has a thicker wall and/or a smaller inner diameter (lumen)
  • the microvalve 30 is designed for use with either of
  • the microvalve 30 includes a body 32 formed of a compressible, resilient elastomeric material.
  • the body 32 is generally solid
  • the valve body 32 includes a generally central region 42 and an elongated central axis indicated at line "A".
  • the central region 42 has slit 44, sliced (i.e., cut or slit) into place during
  • valve 32 whereby the body 32 is substantially, but not completely, split into two generally hemispheric portions 46, 48 each having a generally flat facing surface 50, 52.
  • the body 32 includes thin unslit regions
  • Figures 4 and 5 are cross sectional views of the microvalve 30.
  • Figure 5 depicts the microvalve 30 placed in the inflation tube 18 of the catheter 10 depicted in Figure 1.
  • the inflation tube 18, particularly the housing region 26 thereof, of the catheter 10 acts as a housing and, because the inner diameter of the inflation tube 18 is relatively less than the outer diameter of the microvalve 30 and the tube 18 is made of a resilient elastomeric material, the inflation tube
  • valve 30 tightly encompasses the microvalve body 32. Thus, unless penetrated by a needle or cannula, the valve 30 is closed, i.e., the facing surfaces 50, 52 are in contact.
  • the inflation tube 18 presses
  • tube 18 with an inner diameter of approximately .060 inches and a microvalve body 32 having an outer body diameter of approximately .117 inches.
  • the catheter 10 is placed in the user's body in accordance with the teachings of the
  • the needle penetrates the first unslit area 54 inside and adjacent to the guide recess 38 and, once the unslit area 54 is pierced, the needle simply separates the facing surfaces 50, 52 of the microvalve body as it is advanced
  • inflating air or solution may be injected into the balloon 20.
  • the needle or cannula may be removed from the microvalve
  • stripping area 40 helps removes filling liquid from the exterior surface of the needle, preventing
  • the balloon 20 is emptied by reinserting a blunt needle
  • balloon filling fluid, air or solution may be aspirated or withdrawn. If urgent removal of the
  • inflation tube may be pierced, cut or sliced adjacent to the microvalve between the microvalve
  • the catheter When the balloon is deflated, the catheter may be
  • microvalve body 30 may be made of any suitable resilient, preferably soft, compressive material such as elastic materials like surgical rubber, silastic or silicone. Silicone is the preferred material, particularly that available from Bayer Silicone under the name Baysilone LSR 4040. A preferred cut or slit 44 in the valve body 32 is
  • slit may be further extended to or removed from one or the other of the needle guiding or needle
  • the side edges of the slit 44 may be moved toward or away from the cylindrical peripheral side wall of the microvalve body 32 as long as the structural integrity and self-sealing capacity of the body 32 is not reduced.
  • recess is depicted as stepped inwardly toward the central axis of the body, but it could be
  • microvalve body 32 and inflation tube 18 can be any selected
  • the diameter of the tube 18 and the outer diameter of the valve body 32 should be such that the inflation tube 18 provides a sleeve arrangement for the microvalve body 32 and applies sufficient compressive, radial force to the microvalve body 32 both to hold the body 32 in place in the tube

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Child & Adolescent Psychology (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter intraurétral de contrôle urinaire, qui comprend une valve commandant l'écoulement d'urine et une microvalve auto-obturatrice permettant et facilitant l'utilisation d'une aiguille mousse ou d'une canule pour remplir et vider le ballon. La microvalve permet d'introduire l'aiguille ou la canule avec une résistance minimale tout en présentant une étanchéité adéquate lorsque le ballon est plein et lorsque l'aiguille ou la canule est retirée.
PCT/US1998/013519 1997-07-01 1998-06-30 Catether intrauretral pour controle urinaire WO1999001172A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU81764/98A AU8176498A (en) 1997-07-01 1998-06-30 Intraurethral urinary control catheter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US88661097A 1997-07-01 1997-07-01
US08/886,610 1997-07-01

Publications (1)

Publication Number Publication Date
WO1999001172A1 true WO1999001172A1 (fr) 1999-01-14

Family

ID=25389372

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/013519 WO1999001172A1 (fr) 1997-07-01 1998-06-30 Catether intrauretral pour controle urinaire

Country Status (2)

Country Link
AU (1) AU8176498A (fr)
WO (1) WO1999001172A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005046538A1 (fr) * 2003-11-15 2005-05-26 Rudolf Finkbeiner Dispositif servant a evacuer arbitrairement l'urine contenue dans la vessie urinaire d'un etre humain
WO2013144770A2 (fr) 2012-03-17 2013-10-03 Pinzi Novello Structure de sphincter endo-urétral artificiel
CN110191738A (zh) * 2016-11-16 2019-08-30 拉莫特特拉维夫大学有限公司 用于大脑血流的颅内体积适应器

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993008876A1 (fr) * 1991-11-04 1993-05-13 Bsd Medical Corporation Applicateur introduit dans l'uretre pour traiter la prostate par hyperthermie
WO1996026748A2 (fr) * 1995-02-23 1996-09-06 Cv Dynamics, Inc. Dba Medical, Incorporated Catheter a ballonnet dote d'une valve de decharge a impulsions et d'un collier de retention
US5609583A (en) * 1995-09-21 1997-03-11 Hakki; A-Hamid I. Collapsible catheter
US5634877A (en) * 1989-02-09 1997-06-03 Salama; Fouad A. Urinary control with inflatable seal and method of using same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5634877A (en) * 1989-02-09 1997-06-03 Salama; Fouad A. Urinary control with inflatable seal and method of using same
WO1993008876A1 (fr) * 1991-11-04 1993-05-13 Bsd Medical Corporation Applicateur introduit dans l'uretre pour traiter la prostate par hyperthermie
WO1996026748A2 (fr) * 1995-02-23 1996-09-06 Cv Dynamics, Inc. Dba Medical, Incorporated Catheter a ballonnet dote d'une valve de decharge a impulsions et d'un collier de retention
US5609583A (en) * 1995-09-21 1997-03-11 Hakki; A-Hamid I. Collapsible catheter

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005046538A1 (fr) * 2003-11-15 2005-05-26 Rudolf Finkbeiner Dispositif servant a evacuer arbitrairement l'urine contenue dans la vessie urinaire d'un etre humain
WO2013144770A2 (fr) 2012-03-17 2013-10-03 Pinzi Novello Structure de sphincter endo-urétral artificiel
CN110191738A (zh) * 2016-11-16 2019-08-30 拉莫特特拉维夫大学有限公司 用于大脑血流的颅内体积适应器
CN110191738B (zh) * 2016-11-16 2021-11-02 拉莫特特拉维夫大学有限公司 用于大脑血流的颅内体积适应器
US11565091B2 (en) 2016-11-16 2023-01-31 Ramot At Tel-Aviv University Ltd. Intracranial volume adaptor for cerebral blood flow

Also Published As

Publication number Publication date
AU8176498A (en) 1999-01-25

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