Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
  • A61M25/0075—Valve means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/1002—Balloon catheters characterised by balloon shape
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
  • A61M29/02—Dilators made of swellable material
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/10—Location thereof with respect to the patient's body
  • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
  • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
  • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
  • A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/20—Type thereof
  • A61M60/295—Balloon pumps for circulatory assistance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/40—Details relating to driving
  • A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/50—Details relating to control
  • A61M60/508—Electronic control means, e.g. for feedback regulation
  • A61M60/562—Electronic control means, e.g. for feedback regulation for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
  • A61M60/569—Electronic control means, e.g. for feedback regulation for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow synchronous with the native heart beat
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/80—Constructional details other than related to driving
  • A61M60/841—Constructional details other than related to driving of balloon pumps for circulatory assistance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/80—Constructional details other than related to driving
  • A61M60/841—Constructional details other than related to driving of balloon pumps for circulatory assistance
  • A61M60/843—Balloon aspects, e.g. shapes or materials
• • 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
  • A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
  • A61F2/0013—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body inflatable
• • 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
  • A61F2/0027—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening inflatable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/10—Location thereof with respect to the patient's body
  • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
  • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
  • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/20—Type thereof
  • A61M60/247—Positive displacement blood pumps
  • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
  • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
  • A61M60/274—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps

Definitions

• Device for temporarily closing a body canal in particular useful for cardiac assistance by back pressure.
• the invention mainly finds application in the field of cardiac assistance by counter-pulse where this device is introduced into the aorta, and will be described below for reasons of clarity, in the context of this application. It is obvious, however, that the invention must be considered to have a much broader scope which extends to any use requiring a possibly controlled obturation of any body canal such as the esophagus, the trachea, the digestive tract. or urinary tract.
• cardiac assistance by counterpulse is mainly used in interventional cardiology to ensure cerebral irrigation during the treatment of coronary affections.
• This assistance is generally carried out using an elastic balloon catheter placed in the aorta of the patient obstructing this artery in the inflated state in a controlled manner in synchronism with the cardiac pulsations. This has the effect of blocking the blood going towards the lower parts of the body so as to favor, during systole, only the upper food in particular of the heart and the brain.
• the catheters currently used for the implementation of this technique generally consist of a tube comprising a first channel allowing the passage of a guide intended to facilitate the positioning of the balloon and a second channel intended to allow the inflation and deflation of the ball.
• Synchronism with heartbeats is obtained by means of a slave pump.
• the balloon at the end of inflation presses against the internal wall of the artery.
• the ball also carries in its movement the various devices necessary for the intervention and thus tackles them with each pulse. against the aortic wall, the aforementioned risks of trauma are further increased.
• the main object of the present invention is to solve the technical problem consisting in the supply of a temporary closure device of a new design which can in particular be implemented easily and without trauma for the body canal. .
• the solution according to the present invention consists of a device for temporarily closing a body channel in which a fluid circulates, in particular useful for cardiac assistance by back pressure, characterized in that it includes:
• a first inflatable structure defining, in the inflated state, a sleeve shaped to conform to the internal surface of said channel by providing a central conduit for the passage of said body fluid;
• a second inflatable and deflatable structure independently of the first with radial expansion, maintained by said first structure and shaped to allow the inflated state to close substantially completely said central duct formed after inflation of said first structure;
• the originality of the device according to the present invention lies mainly in the fact that the obturation of the body channel is carried out practically without any impact against the internal wall of the body channel.
• the inflation of the aforementioned second structure causing the closure of said channel is carried out radially from the outside to the inside, unlike the devices of the prior art using a balloon with radial expansion from the inside. outwards.
• the inventors formulated and sought to solve the new technical problem consisting in the supply of a device capable of providing "active" assistance resulting, in the context of cardiac assistance by counter-pulse, by a possibility of increasing the volume of blood expelled to the brain by means of the obturation device.
• the aforementioned second structure is shaped in such a way that its inflation causes a displacement of the fluid contained in the aforementioned central duct in the axial direction of the body channel.
• such a conformation leads, in the context of the application illustrated by way of example, to a pumping system of the peristaltic type expelling, each time the aorta is closed, a volume of blood to the corresponding brain. substantially at the volume of the second structure in the inflated state.
• the assistance thus carried out can be qualified as activated.
• the obturation of the central duct during inflation is first carried out at a point close to the proximal end of said duct and then propagates in an axial direction towards the distal end of said drove.
• the propagation takes place in the opposite direction, that is to say from the distal end towards the proximal end of the conduit central.
• the aforementioned first inflatable structure comprises a spirally wound tube whose turns can be contiguous or preferably non-contiguous.
• this first structure can also be produced in the form of a double-walled tube as for example described in American patent No. 5,108,370 incorporated here by reference.
• the first inflatable structure of the device according to the present invention fulfills a double function.
• the aforementioned second inflatable structure consists of a double-walled tube.
• the external wall of this tube which is held by the first inflatable structure, while the internal wall is deformed during inflation until the above-mentioned central duct is substantially closed.
• the spirally wound tube forming the aforementioned first inflatable structure is disposed between the two walls of the tube constituting the aforementioned second inflatable structure.
• the double-walled tube constituting the aforementioned second inflatable structure can be disposed internally to the first inflatable structure by being fixed thereon either directly, for example by gluing, or indirectly by means of any suitable connection means.
• the obturation device further comprises a catheter intended to allow its positioning inside the body channel.
• this catheter will be arranged radially and externally relative to the aforementioned first inflatable structure.
• the present application also aims to cover the use of a device for closing a body channel as defined above for the manufacture of a device for assisting cardiac assistance by back pressure.
• FIG. 1 is a schematic end view showing a temporary closure device of a body canal according to the invention shown before its implantation;
• FIG. 2 is a sectional view along line II - II of Figure 1;
• FIG. 2A is a sectional view along line A-A of Figure 2;
• FIG. 2B is a sectional view along line BB of Figure 2;
• - Figure 3 is an end view similar to Figure 1 of a temporary closure device according to the present invention shown in a position of use where only the first structure is in the inflated state;
• - Figure 4 is a sectional view along line IV-IV of Figure 3;
• - Figure 4A is a sectional view along line A-A of Figure 4;
• FIG. 4B is a sectional view along line B-B of Figure 4.
• FIG. 5 is an end view similar to Figure 3 of a temporary closure device according to the present invention shown in the position of use during inflation of the second structure;
• - Figure 6 is a sectional view along line VI-VI of Figure 5;
• FIG. 6A is a sectional view along line A-A of Figure 6;
• FIG. 6B is a sectional view along line B-B of Figure 6;
• FIG. 7 is an end view similar to Figures 3 and 5 of a temporary closure device according to the present invention shown in the position of use after inflation of the first and second inflatable structures mentioned above;
• FIG. 8 is a sectional view along line VIII-VIII of Figure 7;
• FIG. 8A is a sectional view along line A-A of FIG. 8 and
• FIG. 8B is a sectional view along line BB of Figure 8.
• Figures 1 to 8B there is therefore shown illustrated a currently preferred embodiment of a temporary closure device of a body channel in its different positions: - prior to its installation ( Figures 1 to 2B);
• a device for temporarily closing a co ⁇ oral canal comprises two independently inflatable structures.
• the first inflatable structure in the inflated state, defines a sleeve shaped to conform to the internal surface of the co ⁇ orel channel by providing a central duct 4.
• This sleeve can be substantially cylindrical, as in the example shown, but can by construction have other shapes, such as for example conical or diabolo, to adapt to the anatomy of the implantation site.
• This first structure is constituted, in the example shown, by a tube 1 wound in a spiral, and whose turns are not contiguous.
• the tube 1 can be produced for example from a material such as a semi-rigid thermoplastic, such as in particular a polyamide, a polyurethane or a copolymer of the PEBAX® type sold by the company ATOCHEM.
• the second inflatable structure is constituted in the example represented by a double-walled tube, namely an external wall or membrane 2 and an elastic internal wall or membrane 3.
• the external membrane 2 is preferably arranged outside the spirally wound tube 1 while being held pressed by the latter (in the inflated state) against the internal wall of the co ⁇ orel channel not shown.
• the elastic internal membrane 3 will preferably be made of a thermoplastic material which may be a polyamide, a polyurethane, a copolymer of the PEBAX® type or else a silicone.
• outer membrane 2 which will preferably be made of the same material as the inner membrane 3.
• the double-track tube constituting the second inflatable structure has a length substantially equal to the length of the sleeve formed by the tube 1 in the inflated state.
• the swelling of the above-mentioned double-walled tube is accompanied by a radial expansion towards the inside of its internal membrane 3 which will gradually cause the central duct 4 to be closed.
• the thickness of the internal wall 3 of the double-track tube forming the second inflatable structure will gradually vary from one end to the other of the duct, being smaller on the side of the proximal end in the case an operation of the peristaltic type, greater on the side of the proximal end in the case of an operation of the anti-peristaltic type.
• the obturation device according to the present invention further comprises a catheter generally designated by the reference numeral 5 intended to allow its implantation inside the co ⁇ orel canal.
• This catheter is constituted, in a manner known per se, by an elongated flexible tube comprising a proximal part not shown and a distal part at the level of which are the first and second inflatable structures mentioned above.
• the catheter 5 has a first lumen 6 extending over its entire length and allowing the passage of a guide wire, not shown.
• the catheter 5 further comprises means allowing the fluid communication of each of said first and second inflatable structures with a source of fluid supply.
• the catheter 5 comprises a second lumen 8 and a third lumen 7 extending substantially parallel to each other over a major part of its length and communicating respectively with the inflation chambers of the first and of the second inflatable structure, namely by means of a radial hole made in the wall of the catheter, or preferably by means of a flexible connector.
• These second and third lumens are connected at the proximal end of the catheter 5 to a source of fluid supply allowing the inflation and deflation of the first and second inflatable structures.
• the catheter 5 will be equipped for this purpose partly proximally with a three-way connector of the LUER LOCK type.
• the fluid used for inflation will for example be a gas or a pressurized liquid.
• the reference numeral 9 represents a flexible connector connecting the third lumen 7 to the inflation chamber of the second inflatable structure.
• the catheter 5 is disposed radially and externally relative to the spirally wound tube 1 constituting the first inflatable structure along a generatrix of the sleeve formed by the latter in the inflated state.
• the catheter 5 is arranged between the external membrane 2 of the second structure and the external surface formed by the tube 1.
• the catheter 5 can be placed inside the spirally wound tube 1, by being connected directly or indirectly to it.
• the catheter 5 carrying at its distal part the first and second inflatable structures is introduced using a metal guide, in a conventional manner, up to the level of the chosen implantation site.
• the first inflatable structure is then inflated by forming a sleeve coming to marry the internal surface of the channel while providing an open central duct allowing the circulation of the co ⁇ orel fluid in the direction indicated by the arrow F in FIG. 4.
• the second inflatable structure is then inflated in synchronism with the heartbeat by means of a conventional pump.
• the thickness of the internal wall 3 being smaller on the proximal side than on the distal side, the obturation of the central duct resulting from the inflation of the second structure is first carried out at a point close to the proximal end of the central duct 4 defined by the spirally wound tube 1, as shown in Figure 6.
• an elastic cylindrical sheath or an elastic wire wound in a spiral and arranged around the first and second inflatable structures to allow the folding of the latter and an easy extraction of the catheter carrying these structures, from the co ⁇ orel channel in which it was introduced.
• the temporary closure device which has just been described is therefore particularly advantageous in comparison with the devices known from the state of the art, insofar as it makes it possible to implement active and non-traumatic assistance for the coeloreal canal. .

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Life Sciences & Earth Sciences (AREA)
• Cardiology (AREA)
• General Health & Medical Sciences (AREA)
• Hematology (AREA)
• Public Health (AREA)
• Biomedical Technology (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Anesthesiology (AREA)
• Mechanical Engineering (AREA)
• Vascular Medicine (AREA)
• Pulmonology (AREA)
• Biophysics (AREA)
• Geometry (AREA)
• Transplantation (AREA)
• Physics & Mathematics (AREA)
• Child & Adolescent Psychology (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Percussion Or Vibration Massage (AREA)

Applications Claiming Priority (3)

Publications (1)

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ID=9478336

Family Applications (1)

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• 1995
  • 1995-04-21 FR FR9504794A patent/FR2733143B1/fr not_active Expired - Fee Related
• 1996
  • 1996-04-22 EP EP96915067A patent/EP0821598A1/fr not_active Withdrawn
  • 1996-04-22 CA CA002215235A patent/CA2215235A1/en not_active Abandoned
  • 1996-04-22 US US08/945,487 patent/US5861010A/en not_active Expired - Fee Related
  • 1996-04-22 JP JP8531530A patent/JPH11503641A/ja active Pending
  • 1996-04-22 WO PCT/FR1996/000608 patent/WO1996032971A1/fr not_active Application Discontinuation
• 1997
  • 1997-10-20 NO NO974839A patent/NO974839D0/no unknown

Non-Patent Citations (1)

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