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
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/80—Constructional details other than related to driving
  • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
  • A61M60/871—Energy supply devices; Converters therefor
  • A61M60/882—Devices powered by the patient, e.g. skeletal muscle powered 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
  • A61M60/10—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
  • A61M60/152—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 branching on and drawing blood from a blood vessel
• • 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
  • A61M60/161—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 mechanically acting upon the outside of the patient's blood vessel structure, e.g. compressive structures placed around a vessel
• • 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
• • 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
  • A61M60/289—Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] 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
  • A61M60/40—Details relating to driving
  • A61M60/424—Details relating to driving for positive displacement blood pumps
  • A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
• • 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
  • A61M60/424—Details relating to driving for positive displacement blood pumps
  • A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
  • A61M60/43—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic using vacuum at the blood pump, e.g. to accelerate filling
• • 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
  • A61M60/835—Constructional details other than related to driving of positive displacement blood pumps
  • A61M60/837—Aspects of flexible displacement members, e.g. shapes or materials
• • 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
  • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
  • A61M60/857—Implantable blood tubes
• • 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

• the present invention relates to improvements in bio-mechanical hearts of the type using, as a motor element, a skeletal muscle, and more particularly an extra-aortic diastolic counter-pulse system included in such a heart.
• Biomechanical hearts which take the form of a circulatory pump capable of being completely implanted in the rib cage of a patient, in particular in cases of terminal heart failure.
• This pump is actuated by a skeletal muscle, for example the dorsal muscle, which is subjected to electrostimulation in such a way that all the pulsating energy of the pump comes from the metabolism of the muscle which in a way constitutes its motor.
• a major drawback of this system is that, in order to be fully effective, the skeletal muscle must first be subjected to the training mentioned above, so that it is effective only after a delay of the order of 8 at 12 weeks, so it can only be used on patients with pre-terminal heart failure. It cannot therefore be used on patients with very advanced heart failure requiring immediate treatment.
• intra-aortic diastolic counter-pulse systems which have the effect of increasing the coronary flow at the time of diastole and decreasing the afterload by aspirating blood from the heart at the time of systole.
• a balloon is introduced into the patient's aorta, from the femoral artery, which is inflated at the time of diastole and which is deflated at the time of systole.
• the introduction of this balloon into the arterial system of the patient has the disadvantage of causing, when its use is prolonged in time, hemorrhages, infections of the ischaemias of the lower limb and femoro-iliac thromboses.
• the present invention proposes to remedy the drawbacks of the two abovementioned intervention techniques by proposing a bio-mechanical heart able to be operational as soon as its implantation is carried out, so that it is able to be used on patients who have very advanced heart failure, requiring immediate mechanical treatment.
• the present invention thus relates to a bio-mechanical heart of the type comprising means of extra-aortic diastolic counterpulsation constituted by a pumping cage, disposed between two conduits of an aortic bypass, the actuation of which is controlled by a muscle excited by electrical pulses, characterized in that the internal walls of the pumping cage receive a balloon, of substantially annular cross section, so as to provide an axial channel in communication with the two conduits of the aortic bypass, which is connected by a flexible tube to means making it possible to inject a gas flow capable of inflating it, so as to reduce the passage section of the axial channel and to deflate it so as to increase said passage section.
• the gas flow consists of helium.
• the present invention is particularly advantageous in that it makes it possible to make a bio-mechanical heart immediately effective, without waiting for a delay in training the muscle 8. Furthermore, the extra-aortic diastolic counter-pulse system according to the invention does not require interrupting the muscular training phase of muscle 8 and can even help improve its training.
• Figure 1 is a schematic view of a bio-mechanical heart according to the prior art, used in an aorto-aortic application.
• Figure 2 is a longitudinal sectional view of a bio-mechanical core according to the invention.
• Figure 3 is a schematic view of a bio-mechanical heart according to the invention, of the type of that shown in Figure 2, and which is implemented in an aorto-aortic application of the type of that shown in Figure 1 .
• FIG. 4 is a schematic view of an embodiment, in an apico-aortic application, of the bio-mechanical heart shown in FIG. 2.
• the pumping cage 7 is generally made up of a deformable enclosure forming a pump which is actuated by a muscle 8, in particular by a muscle skeletal type of great dorsal, which for this is wrapped around the pumping cage 7.
• the contractions of the muscle 8 are triggered by a myostimulator 11, itself synchronized with the cardiac movements by a sensor 13 fixed on the heart 1 to which it is connected.
• a myostimulator 11 When the muscle 8 is not excited, that is to say when it is released, the cage 7 then has a large diameter and when the muscle 8 is excited, it is then contracted so that the passage section in cage 7 is reduced.
• the aortic valve 10 is closed (which is detected by the sensor 13, and which corresponds to the diastole) the myostimulator 11 sends an electrical pulse to the muscle 8, which is in synchronism with the diastole.
• the muscle 8 is then excited and compresses the pumping cage 7, so that the blood which passes through it is forced back both upstream and downstream.
• FIG. 2 a bio-mechanical heart with a diastolic counterpulse which can be used in aorto-aortic applications, ( Figure 3) as well as apico-aortic ( Figure 4).
• This heart was placed in a bypass 6 created on the aorta 3 by two conduits 5 and 9, a pumping cage 7 around which was wound a skeletal muscle intended, as mentioned previously, to compress the pumping cage 7 when 'he is electrically excited.
• the pumping cage 7 comprises on its internal surface 12, a balloon 15 of substantially annular cross section, so as to provide an axial channel 17 which is connected to the upstream 5 and downstream 9 conduit of the bypass 6.
• the balloon 15 is connected by a flexible tube 19 which leaves the skin after a long subcutaneous journey, to an external pressure and vacuum generator 20 able to successively create in the balloon 15 a pressure, in particular by injection of a gas such as helium, and a vacuum by suction, so, in synchronism with the diastole and the cardiac systole, to inflate and deflate the balloon 15.
• the pressure and vacuum generator 20 is in communication with the native heart 1 by a link 22 and a listening or implantable listening electrode 24.
• the operation of the device is of the same type as that described in FIG. 1, with the difference that, instead of exciting the muscle 8 by an electric discharge in order to compress the pumping cage 7 so as to expel the blood contained in the bypass 6, the balloon 15 is inflated, by blowing helium through the line 19. Likewise, instead of leaving the muscle 8 relax, which had the effect of allowing the pumping cage to regain its volume thus creating suction through the pipe 5, a vacuum is created in the balloon 15 to retract it.
• the present invention has a certain number of advantages and first of all that of making a bio-mechanical heart immediately effective, without waiting for a delay in training the muscle 8.
• the extra-aortic diastolic counter-pulse system according to the invention does not require interrupting the muscular training phase of muscle 8 and can even contribute to improving the training thereof.
• the training phase of muscle 8 it is possible either to eliminate the tube 19 through the cutaneous orifice, or to leave it in place by cutting it flush with the skin and burying it in the sub-tissues. skin.
• the diastolic counter-pulse system according to the invention can also be implemented in bio-mechanical hearts with inlet and outlet valves as well as those used in the so-called apico-aortic arrangements.
• the blood flow from the left ventricle of the heart 1 enters channel 17 at the time of systole and is ejected into the aorta 3 at the time of diastole.
• An intake valve 25 and a discharge valve 26 avoid retrograde flow in the left ventricle, which would be extremely harmful on a hemodynamic level.
• the intake valve 25 is open and the discharge valve 26 is closed at the time of systole.
• the inlet valve 25 is closed and the discharge valve 26 is open at the time of the diastole.
• the extra-aortic counterpulsation balloon 15 has the same effects in this apico-aortic configuration as in the aorto-aortic configuration.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Cardiology (AREA)
• Hematology (AREA)
• Mechanical Engineering (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Vascular Medicine (AREA)
• Rheumatology (AREA)
• External Artificial Organs (AREA)

Applications Claiming Priority (3)

Publications (1)

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ID=9494433

Family Applications (1)

Country Status (6)

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• 1996
  • 1996-07-24 FR FR9609320A patent/FR2751549B1/fr not_active Expired - Fee Related
• 1997
  • 1997-07-24 AU AU38541/97A patent/AU3854197A/en not_active Abandoned
  • 1997-07-24 EP EP97935620A patent/EP0925079A1/de not_active Withdrawn
  • 1997-07-24 WO PCT/FR1997/001385 patent/WO1998003212A1/fr not_active Ceased
  • 1997-07-24 CA CA002261846A patent/CA2261846A1/fr not_active Abandoned
  • 1997-07-24 JP JP10506666A patent/JP2000514687A/ja active Pending

Non-Patent Citations (1)

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