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
  • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
  • A61M60/191—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• • 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
  • A61M60/438—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical
• • 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
  • A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
  • A61M60/468—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means 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
  • A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
  • A61M60/47—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping 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
  • A61M60/50—Details relating to control
  • A61M60/508—Electronic control means, e.g. for feedback regulation
  • A61M60/515—Regulation using real-time patient data
• • 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 a dynamic training process of a skeletal muscle for a biomechanical heart as well as a biomechanical heart using such a muscle.
• a biomechanical heart in the form of a circulatory pump capable of being completely implanted in the chest of a patient, in particular in cases of terminal heart failure.
• This pump is actuated by a skeletal muscle, for example the dorsal muscle, 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 biomechanical heart using a skeletal muscle as a motor, offers the advantage that it does not cause a rejection reaction of the organism because the muscle is taken from the patient in which the biomechanical heart is implanted. .
• This type of dynamic training consists in wrapping the muscle around a training device comprising an elastically deformable element with an internal chamber filled with liquid and terminated at its ends by inflatable bladders, such a device being described in the document WO- A-9205813.
• a training device comprising an elastically deformable element with an internal chamber filled with liquid and terminated at its ends by inflatable bladders, such a device being described in the document WO- A-9205813.
• it is connected to a myostimulator producing periodic electrical impulses of stimulation and when the muscle is thus excited by an electrical impulse, it contracts, which causes a retraction of the central chamber and an expulsion of the liquid to the side bladders which swell.
• the bladders deflate and the liquid returns to the central chamber which increases in volume, and the cycle can then start again.
• the present invention relates to improvements made to this method of training a muscle making it possible to obtain a significant increase in muscle mass and in developed power.
• this dynamic training process for a skeletal muscle intended for use in a biomechanical heart in which the skeletal muscle is wound around a deformable training device capable of being able to contract, by opposing resistance to the contraction, and then return to its initial shape and the skeletal muscle is stimulated, by means of periodic electrical pulses so as to cause its contraction and that of the deformable training apparatus and their subsequent relaxation, is characterized in that during a first step, the skeletal muscle is stimulated by means of electrical impulses having an increasing frequency as a function of time and during a second step, the resistance of the deformable training device is gradually increased. the contraction, the first and second stages possibly overlapping somewhat.
• the invention also relates to a biomechanical heart using as motor a skeletal muscle having been subjected to such dynamic training.
• FIG. 1 is a diagram illustrating the method according to the invention, for the dynamic training of a skeletal muscle intended to be used in a biomechanical heart.
• FIG. 2 is a diagram illustrating the variation, as a function of time, of the frequency of the electrical stimulation pulses and of the resistant mechanical load applied to the muscle during its training.
• FIG. 3 is a diagram illustrating the range of variation of the pressure / volume characteristic for each of the inflatable bladders of the training apparatus.
• Figure 4 is an elevational view, partially in axial section, of a biomechanical ventricle according to the invention, with axial circulation of the blood flow.
• Figure 5 is a cross-sectional view, on a larger scale, taken along the line VV of FIG. 4, the upper half of the figure representing the biomechanical ventricle in the relaxed state while the lower half represents the ventricle in the contracted state.
• - Figure 6 is a diagram of an application of a biomechanical ventricle according to the invention, with axial circulation, for cardiac assistance.
• FIG. 7 is a schematic sectional view of an alternative embodiment of a biomechanical ventricle with transverse circulation of the blood flow.
• FIG. 8 is a schematic perspective view illustrating the different phases of training a muscle housed in a tubular envelope.
• - Figure 9 is a cross-sectional view of the muscle and its envelope wound around the dynamic training apparatus.
• FIG. 10 is a perspective view of a motor muscle of Figures 8 and 9 wound around a spring cage constituting a pericardial device.
• FIG. 11 is a diagram illustrating a muscle wound around the dynamic training apparatus with the interposition of an intermediate envelope.
• - Figure 12 is a schematic axial sectional view of the motor muscle and its intermediate envelope obtained after the training period.
• FIG. 13 is a diagram of an alternative embodiment of a pericardial device comprising a hydraulic transmission system between the pump and the human heart.
• FIG. 14 is a schematic sectional view of an alternative embodiment of the receptor associated with the human heart.
• FIG. 1 is shown schematically the dynamic training process of a skeletal muscle 1, for example the back muscle, intended for use in a biomechanical heart according to the invention.
• This muscle 1 is wound around a dynamic training device 2 and more particularly around a central chamber 2a filled with liquid and extended, at its two ends, by inflatable bladders 2b.
• the material constituting the internal chamber 2a should not be elastic while the material forming the inflatable bladders 2b is.
• this muscle is electrostimulated by connecting it to a myostimulator 3 which is in fact a generator of periodic electrical pulses.
• the muscle When the muscle is excited by one of these impulses, it contracts, which leads to a reduction of the volume of the central chamber 2a and an expulsion of the liquid from this chamber towards the elastic lateral bladders 2b which inflate, so that the training apparatus 2 opposes a contraction resistance of the muscle 1.
• the muscle 1 relaxes and the elastic bladders 2b deflate by expelling the liquid which returns to the central chamber 2a.
• This central chamber 2a then inflates in turn, to return to at least its initial shape, by exerting a positive restoring force on the muscle 1, force directed towards the outside and oriented in the opposite direction to that exerted by the muscle during its contraction. .
• an incremental variation of the frequency of the electrical pulses of the generator 3 is used, and, on the other hand, an incremental variation of the resistant mechanical load which opposes the contraction of the muscle 1.
• the internal volume of the training device 2 is connected to a catheter 5 communicating with an implantable chamber under the skin and making it possible to gradually increase the quantity of liquid found in the central chamber 2a and the inflatable bladders 2b.
• electrical stimulation pulses are applied to this muscle, the frequency of which f gradually increases over time.
• the combination of the first step of increasing frequency electrical stimulation and the second step of gradually increasing resistance to muscle contraction allows a noticeable increase in muscle mass and muscle power.
• the material constituting the two inflatable bladders 2b consists of a silicone of elastic type forming the wall of the bladders and by polymer threads embedded in this wall so that one obtains, for each of the inflatable bladders 2b, a pressure / volume characteristic included in the range delimited between the two limit curves a and b in Figure 3.
• each bladder 2b is made up of three layers, namely an inner layer and an outer layer of material known as "Rehau SI 1511” and a middle layer in material known as "Dow Corning Q3-8111" or "Dow Corning MDX4-4210".
• FIGS. 4 and 5 illustrate an embodiment of a biomechanical heart according to the invention constituting a "ventricle" with axial circulation of the blood flow, using as a motor a skeletal muscle dynamically driven in the manner described above.
• This biomechanical ventricle comprises a muscle 1, previously trained as indicated above, which is connected to a myostimulator 3 and is wound around a tubular pumping cage, deformable 6.
• This cage 6, flexible and elastic, has a central part of large diameter extended by two opposite end portions of smaller diameter.
• the tubular pumping cage 6 comprises a flexible outer casing 7, for example made of silicone, and inside this casing several cambered spring leaves 8, with convexity facing outwards, extending over the entire length of the 'casing 7, from one end to the other of the cage 6, and distributed around the axis of this cage 6.
• the ends of the spring blades 8 are embedded in two transverse stiffening rings 9 housed respectively in the two ends open of the tubular cage 6.
• the tubular cage 6 When the muscle 1 is not excited, that is to say when it is released, the tubular cage 6 has a large diameter and in this case the membrane 11 delimits relatively flattened chambers, as shown in the upper part of FIG. 5.
• the tubular cage 6 is contracted, as well as 'It is shown in the lower part of Figure 5, the spring blades 8 are flattened and close to each other and the membrane 11 then forms chambers which extend inwardly projecting between the spring blades 8, substantially in radial directions.
• the spring blades 8 allow the distension, that is to say the return of the tubular pumping cage 6 to its initial shape at large volume.
• FIG. 6 illustrates a use of the tubular pumping cage 6 produced in the manner illustrated in FIGS. 4 and 5, to constitute an extra-aortic counter-pulse device.
• the tubular pumping cage 6, the muscle 1 of which is electrically connected to a myostimulator 3, is connected to a conduit 13 bypass on the aorta 14 of a patient whose heart is represented at 15.
• the myostimulator 3 sends, in synchronism with the left ventricular diastole, an electrical impulse to muscle 1 to stimulate it. Synchronization is ensured by a sensor 17 for monitoring the cardiac pulses in contact with the heart 15 and connected to the myostimulator 3.
• the tubular pumping cage 6 Due to the excitation of the muscle 1, the tubular pumping cage 6 is compressed and the blood is pumped towards upstream and downstream, as indicated by the arrows. The backflow of blood results in an increase in circulation in the coronaries 18.
• the aortic valve is open (systole) the muscle 1 is not electrically stimulated, it relaxes and the tubular cage 6 expands creating a depression promoting blood circulation in the aorta.
• This biomechanical ventricle with axial circulation of the blood flow can also be used in other topographic configurations, such as between the left atrium and the aorta between the left ventricle and the aorta, between the right atrium and the pulmonary artery. In this case, these biomechanical ventricles will be provided with two connections, namely an inlet connection provided with an inlet valve and an outlet connection provided with a discharge valve.
• the muscle 1 surrounds a flexible pouch not expandable 19 extending outside a hollow body 21, through an opening of the latter.
• the body 21 is separated into two parts by a waterproof membrane 22 (or a piston) delimiting, on one side, a pumping chamber 23 inside the flexible bag 19, containing a liquid such as physiological saline, and , on the other side, a flushing chamber 24.
• the flushing chamber 24 is provided with two connections, namely an inlet connection 25 provided with an inlet valve 26, and an outlet connection 27 provided with '' a discharge valve 28.
• the biomechanical "ventricle” shown in FIG. 7 can be used in partial or total assistance, both for the left heart, between the left ventricle and aortic artery, and for the right heart between the right atrium and the pulmonary artery.
• the inlet 25 and outlet 27 fittings are connected to the circulatory system. It can be used without inlet and outlet valves in an aorto-aortic configuration of extra-aortic counter-pulse.
• the apparatus shown in FIG. 7 can also be used to ensure dynamic training of the muscle 1.
• the inlet 25 and outlet 27 connections are not connected in the circulatory system but they are interconnected by a conduit 29 which is then cut to remove it when from the transition to operation, in order to connect the fittings 25 and 27 to the circulatory system.
• a catheter 31 communicating the pumping chamber 23 with a device for filling this pumping chamber with propellant liquid, during the second step of the dynamic drive process, in order to gradually increase the amount of liquid in the pumping chamber 23, and to be able to regularly measure the pressure of this liquid to follow the evolution of muscle performance.
• the catheter 18 can optionally be removed during the transition to normal operation but it can also be left in place to serve to measure the pressure of the propellant liquid.
• FIG. 8 and 9 show an alternative embodiment in which the muscle 1 is previously housed, before the implementation of the dynamic training process, in a tubular sheath 32 constituted by a polymer membrane which protects the muscle during the process dynamic training and ensures its non-adhesion to surrounding tissues.
• the sheath 32 is made of any natural, artificial or synthetic polymer, but preferably it is constituted by a polymer substituted in particular by fluorine, such as polymers of the polytetrafluoroethylene type.
• FIG. 10 illustrates a pericardial device comprising a muscle 1, around a flexible and elastic tubular cage 30, open at its two ends. One of the openings of the cage 30 has a diameter large enough to allow the introduction of a human heart inside the cage 30. The stimulation of the muscle 1 then causes the contraction of the cage 30 and that of the human heart housed tightly in this cage. If the muscle is not long enough, we can provide an extension in Y 33, made of a resistant polymer, such as Dacron or PTFE.
• FIG. 11 and 12 show an alternative embodiment in which, during the dynamic training of the muscle, there is interposed between the muscle 1 and the dynamic training apparatus 2 a membrane 34 wound around an axis, on the surface continuous, open at both ends.
• This membrane 34 is preferably made of a material "colonizable" by the connective tissue.
• the flexible tubular "cage" 35 thus obtained comprises, on the outside, the muscle 1 and, on the inside, the membrane 34 adhering to the muscle and colonized by the cells of the connective tissue.
• the cage 35 can be used directly as a pumping chamber and it can be connected to arterial prostheses 36.
• FIG. 13 illustrates an embodiment of a pericardial device in which the muscle 1 is wound around a flexible and elastic cage 37, forming a pumping chamber or a transmitter of pressure pulses, the internal volume of which communicates , by a conduit 38, with a pocket 39 in the form of a bowl in which is housed a human heart 15.
• the pocket 39 which forms a receptor for pressure pulses, has a hollow wall and it includes an external non-expandable envelope 41 and a internal envelope 42 expandable in contact with the heart.
• the flexible and elastic cage 37, with variable pumping volume, is thus connected by a hydraulic transmission device to the pocket 39.
• the cage 37 contracts, under the action of the electrically stimulated muscle 1, it expels liquid, by through the conduit 38, inside the pocket 39, in other words it creates a pressure pulse transmitted to the pocket 39.
• the excess liquid arriving in the pocket causes an expansion of the internal envelope 42 and consequently a contraction of the human heart 15.
• the conduit 38 is connected, by means of a bypass conduit 43, to a chamber 44 situated under the skin 45 of a patient and closed by a perforable membrane 46. Through this membrane can be introduced a needle 47 for replenishing propellant. Furthermore, a needle for measuring the pressure 48 can also be introduced through the membrane 46.
• the conduit 38 of the hydraulic transmission device terminates in a pressure pulse receiver comprising an expandable envelope 49 housed inside an external non-expandable pocket 51, pocket inside which the human heart is also located 15.
• the expandable cover 49 is in contact on the one hand with the external pocket 51 and on the other hand with the human heart 15 so that the pressure pulses in the conduit 38 result in an increase in volume of the expandable envelope 49 and a contraction of the heart 15.
• This pipe allows transcutaneous connection to a suction system (suction) during a short period.
• This transcutaneous connection can be removed after a few days when the internal surface of the hydraulic bag 39 (made of silicone, for example), adheres permanently to the epicardium.

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

Applications Claiming Priority (7)

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• 1994
  • 1994-05-13 CA CA002162585A patent/CA2162585A1/fr not_active Abandoned
  • 1994-05-13 WO PCT/FR1994/000571 patent/WO1994026326A1/fr not_active Application Discontinuation
  • 1994-05-13 US US08/549,721 patent/US5814102A/en not_active Expired - Fee Related
  • 1994-05-13 EP EP94916281A patent/EP0774984A1/de not_active Ceased
  • 1994-05-13 AU AU67998/94A patent/AU692770B2/en not_active Ceased
  • 1994-05-13 JP JP6525076A patent/JPH09506517A/ja active Pending

Non-Patent Citations (1)

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