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WO2009048377A1 - Procédé d'aide à la circulation dans le coeur - Google Patents

Procédé d'aide à la circulation dans le coeur Download PDF

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Publication number
WO2009048377A1
WO2009048377A1 PCT/SE2008/000566 SE2008000566W WO2009048377A1 WO 2009048377 A1 WO2009048377 A1 WO 2009048377A1 SE 2008000566 W SE2008000566 W SE 2008000566W WO 2009048377 A1 WO2009048377 A1 WO 2009048377A1
Authority
WO
WIPO (PCT)
Prior art keywords
energy
wall portion
compression
patient
stimulation
Prior art date
Application number
PCT/SE2008/000566
Other languages
English (en)
Inventor
Peter Forsell
Original Assignee
Milux Holding Sa
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 Milux Holding Sa filed Critical Milux Holding Sa
Priority to PCT/SE2008/000566 priority Critical patent/WO2009048377A1/fr
Publication of WO2009048377A1 publication Critical patent/WO2009048377A1/fr

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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
    • A61M60/10—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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • 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
    • A61M60/10—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
    • A61M60/289—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
    • A61M60/465—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
    • 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
    • A61M60/873—Energy supply devices; Converters therefor specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
    • 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
    • A61M60/876—Implantable batteries
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means
    • A61M2205/8243—Charging means by induction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36564—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36578—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A61N1/403—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals for thermotherapy, e.g. hyperthermia

Definitions

  • the present invention relates to assisting the flow of blood in the heart. [0001] BACKGROUND
  • Cardiac compression is a known method of assisting a failing heart and has been used for many years. In its most simple form it is applied on the chest either manually or using an automatic chest compression device.
  • the external methods are basically simple lifersaving methods and can only be used to alleviate acute heart failures.
  • Implantable mechanical heart compression devices could potentially provide treatment for many patients suffering from a failing heart.
  • Another more serious disadvantage is that the element that compresses the heart muscle may injure the tissue wall of the heart.
  • the mechanical element might erode into the heart over time, and in a worst case, penetrate the wall portion of the heart.
  • blood circulation in the hearttissue is eventually hampered by the pressure exerted by the mechanical element, so that poor blood circulation, or worse, no blood circulation results in deterioration of the heart tissue.
  • One solution to prevent tissue deterioration due to poor blood circulation could be to apply two or more separately operating compressing elements along respective wall portions of the heart and operate the elements sequentially, whereby each tissue wall portion would have time to recover, i.e., restore normal blood circulation while one of the other tissue wall portions is compressed.
  • an apparatus devised in accordance with this solution would have several disadvantages. First, the apparatus would require a large amount of space, making it impractical to implant. Second, the operation of the apparatus in moving the compressing elements between compressing and non-compressingpositions day and night would require a large power supply.
  • the object of the present invention is to provide a method for controlling the flow blood in lumens formed by tissue walls of the heart so as to at least substantially or even completely eliminate the injured tissue wall problems that have resulted from implanted prior art devices that constrict/compresses the heart. Constriction of the heart is more commonly referred to as compression of the heart and henceforth the term compressing will be used.
  • a method for controlling the flow of blood in a lumen that is formed by the tissue wall of a heart comprising:
  • the present invention provides an advantageous combination of the method steps (a) and (b), which results in a two-stage influence on the flow of fluids and/or other bodily matter in the lumen of the heart.
  • applying a relatively weak force against the wall portion gently compresses the tissue wall and the compressed wall portion is stimulated to achieve the desired final influence on the flow in the lumen.
  • the phrase "gently compresses a portion of the tissue wall” is to be understood as compressing the wall portion without substantially hampering the blood circulation in the tissue wall.
  • step (b) is performed by intermittently and individually stimulating different areas of the wall portion.
  • Such an intermittent and individual stimulation of different areas of the wall portion of the heart allows tissue of the wall portion to maintain over time substantially normal blood circulation.
  • the method of the present invention can be practiced on any place on the heart, in particular, but not limited to, the ventricles of the heart, which is a significant advance in the art.
  • the compression step (a) and stimulation step (b) are performed independently of each other. Steps (a) and (b) may be performed simultaneously. Optionally, step (b) may or may not be performed while step (a) is performed.
  • the compression of the wall portion can be calibrated by stimulating the wall portion while adjusting the compression of the wall portion until the desired flow in heart is obtained.
  • the compression step (a) and stimulation step (b) are suitably performed to compress and stimulate the wall portion to an extent that depends on the flow that is desired to be achieved in a specific application of the method.
  • the method may further comprise sensing a physical parameter of the patient and adjusting the intensity of the stimulation of the wall portion in response to the sensed parameter.
  • the method may further comprise (c) ceaseing stimulating the wall portion to increase the flow in the lumen and (d) releasing the wall portion to restore the flow in the lumen.
  • the compressed wall portion are suitably simultaneously and cyclically stimulated, wherein the first length is progressively stimulated in the upstream direction of the lumen and the second length is progressively stimulated in the downstream direction of the lumen.
  • the method may further comprise sensing a physical parameter of the patient or functional parameter of implanted components and adjusting the stimulation of the wall portion in response to the sensed parameter.
  • the intensity of the stimulation of the wall portion may be increased in response to a sensed pressure increase in the lumen or vascular system.
  • the method may comprise sensing a physical parameter of the patient's that relates to the pressure in the lumen, and controlling the stimulation of the wall portion in response to the sensed parameter.
  • Any sensor for sensing a physical parameter of the patient such as a pressure in the patient's body that relates to the pressure in the lumen may be provided, wherein the stimulation is controlled in response to signals from the sensor.
  • a sensor may for example sense the pressure against the implanted compression device or the pressure on the tissue wall of the heart.
  • step (b) is preferably performed by intermittently and individually stimulating different areas of the wall portion so that the flow in the lumen continues to be restricted as desired and each area of the wall portion essentially maintains its natural physical properties over time to prevent the area from being injured.
  • each area of the wall portion is stimulated during successive time periods, each time period being short enough to maintain over time satisfactory blood circulation in the area.
  • the areas are stimulated so that an area that currently is not stimulated will have time to restore substantially normal blood circulation before it is stimulated again.
  • stimulation step (b) is suitably performed by stimulating one or more of different areas of the wall portion at a time, preferably by sequentially stimulating the different aeras of the wall portion or by shifting the stimulation from one area to another over time.
  • stimulation step (b) is performed by cyclically propagating the stimulation of the areas along the wall portion, for example in accordance with a determined stimulation pattern.
  • the method may further comprise controlling, preferably by the patient, the compression and/or stimulation of the wall portion from outside the patient's body. .
  • the method comprises sensing a physical parameter of the patient and controlling, preferably automatically, the compression and/or stimulation of the wall portion in response to the sensed parameter.
  • the compression step (a) may be performed by compressing any wall portions of a series of wall portions of the heart's tissue wall, respectively, either in random or in accordance with a predetermined sequence.
  • the stimulation step (b) may be performed by stimulating any of the compressed wall portions of the series of wall portions.
  • step (a) may be performed by compressing all of the wall portions of the series of wall portions
  • step (b) may be performed by stimulating any compressed wall portions in random or in accordance with a predetermined sequence.
  • the method of the present invention can be practised for actively moving the blood in lumen of a patient's heart.
  • steps (a) and (b) are co-operated to move the blood in the lumen.
  • Step (a) is performed by compressing the wall portion
  • step (b) is performed by stimulating the compressed wall portion of the lumen.
  • the method further comprises (c) increasing the compression of the wall portion to move the blood in the lumen.
  • Step (a) is performed by compressing the wall portion
  • step (b) is performed by progressively stimulating the compressed wall portion to cause progressive contraction of the wall portion to move the blood in the lumen.
  • the compressed wall portion is progressively stimulated in the downstream or upstream direction of the lumen.
  • Step (a) is performed by varyingly compressing the wall portion to vary the flow in the lumen
  • step (b) is performed by progressively stimulating the compressed wall portion to cause progressive contraction of the wall portion to move the blood in the lumen.
  • the compressed wall portion is progressively stimulated in the downstream or upstream direction of the lumen.
  • Step (a) is performed by varyingly compressing different areas of the wall portion to cause progressive compression of the wall portion in the downstream or upstream direction of the lumen, and the compressed wall portion is progressively stimulated to cause progressive contraction thereof in harmony with the progressive compression of the wall portion.
  • the method may further comprise providing at least one elongated compression element extending along the wall portion, and controlling the elongated compression element to progressively compress the wall portion in the downstream or upstream direction of the lumen.
  • the elongated compression element suitably comprises contact surfaces dimensioned to contact a length of wall portion, and the method may further comprise providing a plurality of stimulation elements distributed along the contact surfaces, and controlling the stimulation elements to stimulate the different areas of the wall portion along the length of the wall portion.
  • Step (a) is performed by compressing any one of a series of wall portions of the tissue wall, and step (b) is performed by stimulating the compressed wall portion.
  • the method further comprises successively compressing the wall portions of the series of wall portions to move the blood in the lumen in a peristaltic manner.
  • the method further comprises providing at least one compression element and at least one stimulation element positioned on the compression element, moving the compression element along the heart in the flow direction in the lumen to successively compress the wall portions of the series of wall portions, and using the stimulation element to stimulate the wall portion compressed by the compression element.
  • the method further comprises cyclically moving the compression element along the wall portions of the series of wall portions.
  • the method further comprises providing a plurality of compression elements and stimulation elements positioned on the compression elements, moving each compression element along the heart to successively compress the wall portions of the series of wall portions, and using the stimulation elements to stimulate the wall portion compressed by any one of the compression elements.
  • the method further comprises cyclically moving the compression elements one after the other along the wall portions of the series of wall portions.
  • the method further comprises providing a rotor carrying the compression elements, and rotating the rotor so that each compression element cyclically compresses the wall portions of the series of wall portions.
  • Each compression element suitably comprises a roller that rolls on the heart to compress the latter.
  • Step (a) is performed by compressing any wall portions of a series of wall portions of the heart's tissue wall, respectively, wherein the wall portions of the series of wall portions are successively compressed along the heart to move the blood in the lumen of the patient's heart.
  • the stimulation step (b) is performed by stimulating any compressed wall portions of the series of wall portions.
  • Step (a) is performed by compressing wall portions of a series of wall portions
  • step (b) is performed by stimulating the compressed wall portions one after the other, so that the wall portions of the series of wall portions are successively contracted along the heart to move the blood in the lumen of the patient's heart.
  • Step (a) is performed by compressing the wall portion at an upstream or downstream end.
  • the method further comprises (c) compressing the wall portion between the upstream and downstream ends thereof, to move the blood contained in the wall portion between the upstream and downstream ends thereof downstream or upstream in the lumen.
  • the method further comprises stimulating the wall portion between the upstream and downstream ends thereof, as (c) is performed.
  • step (a) is performed by compressing the wall portion at the upstream end
  • step (b) is performed by stimulating the compressed wall portion at the upstream end, whereby the blood contained in the wall portion between the upstream and downstream ends thereof is moved downstream in the lumen, as step (c) is performed.
  • step (a) is performed by compressing the wall portion at the downstream end
  • step (b) is performed by stimulating the compressed wall portion at the downstream end, whereby the blood contained in the wall portion between the upstream and downstream ends thereof is moved upstream in the lumen, as step (c) is performed.
  • step (b) may be performed by stimulating the wall portion with electric pulses.
  • step (b) is performed by intermittently stimulating different areas of the wall portion so that at least two of the areas are stimulated at different points of time. I.e., the stimulation is shifted from one area to another area over time.
  • step (b) is performed by intermittently stimulating the areas of the wall portion so that an area of the different areas that currently is not stimulated has time to restore substantially normal blood circulation before it is stimulated again.
  • step (b) is performed by intermittently stimulating the areas during successive time periods, wherein each time period is short enough to maintain satisfactory blood circulation in the area until the laps of the time period.
  • step (b) may be performed by stimulating the wall portion with, preferably cyclically, varying stimulation intensity.
  • step (b) is performed by intermittently stimulating the wall portion with pulses, preferably in the form of pulse trains.
  • the pulse trains can be configured in many different ways by varying pulse parameters.
  • the pulse amplitudes of the pulses of the pulse trains, the off time periods between the individual pulses of each pulse train and the width and repetition frequency of each pulse may be varied.
  • the off time periods between the pulse trains may be varied, wherein each off time period between the pulse trains is kept long enough to restore substantially normal blood circulation in each area of the wall portion, when the area is not stimulated during the off time periods.
  • step (b) may be performed by stimulating one or more of the areas at a time with pulses, by cyclically propagating the stimulation of the areas with pulses along the wall portion, and/or by propagating the stimulation of the areas with pulses in accordance with a determined stimulation pattern.
  • each off time period between the pulse trains is controlled to last long enough to restore substantially normal blood circulation in the area when the latter is not stimulated during the off time periods.
  • step (b) is performed by electrically stimulating the wall portion, with electric pulses to cause contraction of the wall portion.
  • This embodiment is particularly suited for applications in which the patient's wall portion includes muscle fibers that react to electrical stimula.
  • the wall portion that includes the muscle fibers is stimulated with such electric pulses, preferably in the form of electric pulse trains, when the wall portion is in the compressed state, to cause contraction of the wall portion.
  • the configuration of the electric pulse trains may be similar to the above described pulse trains and different areas of the wall portion may be electrically stimulated in the same manner as described above.
  • the method comprises providing at least one, preferably a plurality of electrical elements, such as electrodes, engaging and stimulating the wall portion with electric pulses.
  • the electrical elements may be placed in a fixed orientation relative to one another.
  • the method comprises electrically energizing the electrical elements, preferably by cyclically energizing each element with electric pulses.
  • the electrical elements may be energized so that the electrical elements are energized one at a time in sequence, or so that a number or groups of the electrical elements are energized at a time. Also, groups of electrical elements may be sequentially energized, either randomly or in accordance with a predetermined pattern.
  • the method may further comprise applying the electrical elements on the patient's wall portion so that the electrical elements form any pattern of electrical elements, preferably an elongate pattern of electrical elements extending lengthwise along the wall portion and the elements abut the respective areas of the wall portion.
  • the electrical elements may be successively energized along the elongate pattern of electrical elements in a direction opposite to or in the same direction as that of the flow in the patient's lumen.
  • the electrical elements may be successively energized along the elongate pattern of electrical elements from a position substantially at the center of the compressed wall portion towards both ends of the elongate pattern of electrical elements.
  • the elongate pattern of electrical elements may include one or more rows of electrical elements extending lengthwise along the heart. Each row of electrical elements may form a straight, helical or zig-zag path of electrical elements, or any form of path.
  • the electrical elements may be energized so that the electrical elements currently energized form at least one group of adjacent energized electrical elements, wherein the elements in the group of energized electrical elements form a path of energized electrical elements extending at least in part around the patient's heart.
  • the elements in the group of energized electrical elements form two paths of energized electrical elements extending on mutual sides of the patient's heart or more than two paths of energized electrical elements extending on different sides of the patient's heart, preferably at least substantially transverse to the flow direction in the lumen of the heart.
  • the electrical elements form a plurality of groups of elements, wherein the groups form a series of groups extending along the patient's heart in the flow direction in the patient's heart.
  • the electrical elements of each group of electrical elements may form a path of elements extending at least in part around the patient's heart.
  • the electrical elements of each group of electrical elements may form more than two paths of elements extending on different sides of the patient's heart, preferably substantially transverse to the flow direction in the patient's heart.
  • the groups of electrical elements in the series of groups may be energized in random or in accordance with a predetermined pattern.
  • the groups of electrical elements in the series of groups may be successively energized in a direction opposite to or in the same direction as that of the flow in the patient's heart, or in both said directions starting from a position substantially at the center of the compressed wall portion.
  • groups of energized electrical elements may form advancing waves of energized electrical elements, as described above. I.e., the groups of electrical elements may be energized so that energized electrical elements form two waves of energized electrical elements that simultaneously advance from the center of the compressed wall portion in two opposite directions towards both ends of the elongate pattern of electrical elements.
  • stimulation step (b) is performed by thermally stimulating the wall portion.
  • the wall portion may be cooled, when the wall portion is compressed, to cause contraction of the wall portion.
  • the wall portion may be compressed, and the compressed wall portion may be cooled to cause contraction thereof.
  • the wall portion may be heated, when the wall portion is compressed and contracted, to cause expansion of the wall portion.
  • the wall portion includes a blood vessel
  • the blood vessel may be cooled to cause contraction thereof, or heated to cause expansion thereof.
  • thermal stimulation may be practised in any of the embodiments of the present invention.
  • thermal stimulation may be practised in any of the embodiments of the present invention, and the thermal stimulation may be controlled in response to various sensors, for example strain, motion or pressure sensors.
  • the method comprises providing a compression device that compresses the wall portion, a stimulation device that stimulates the compressed wall portion and a control device that controls the compression device and/or the stimulation device.
  • the method comprises operating the control device from outside the patient's body, preferably by using the control device to wirelessly control the compression device and/or stimulation, device.
  • the wireless control is preferably performed in a nonmagnetic manner, whereby implanted magnetic devices can be avoided.
  • the control device comprises a hand-held wireless remote control operated by the patient.
  • control device comprises a manually operable switch for switching on and off the compression device and/or stimulation device.
  • the method comprises subcutaneously implanting the switch in the patient and manually operating the the implanted switch from outside the patient's body.
  • the control device comprises a programmable internal control unit, such as a microprocessor, and the method comprises implanting in the patient the internal control unit and controlling by the internal control unit the compression device and/or stimulation device.
  • the control device may also comprise an external control unit outside the patient's body.
  • the method comprises controlling by the external control unit the compression device and/or stimulation device and, optionally, using the external control unit to program the implanted internal control unit.
  • the internal control unit may be programmable for controlling the compression device and/or stimulation device over time, for example in accordance with an activity schedule program.
  • the compression of the wall portion can be calibrated by using the control device to control the stimulation device to stimulate the wall portion while controlling the compression device to adjust the compression of the wall portion.
  • the method comprises implanting at least one sensor and controlling by the control device the compression device and/or the stimulation device in response to signals from the sensor.
  • the sensor directly or indirectly senses at least one physical parameter of the patient, functional parameter of the apparatus, or functional parameter of a medical implant in the patient.
  • sensor for sensing physical parameters may be used.
  • motion sensors for sensing heart motion i.e. natural contractions, such as stomach or intestinal contractions
  • pressure sensors for sensing pressure in the heart i.e. natural contractions, such as stomach or intestinal contractions
  • strain sensors for sensing strain of the heart i.e. strain sensors for sensing strain of the heart
  • flow sensors for sensing fluid flow in the lumen of the heart spectro-photometrical sensors
  • Ph-sensors for acidity or alkalinity of the fluid in the lumen of the heart Ph-sensors for acidity or alkalinity of the fluid in the lumen of the heart
  • oxygen-sensors sensors for sensing the oxygen content of the fluid in the lumen of the heart
  • sensors for sensing the distribution of the stimulation on the stimulated heart Any conceivable sensors for sensing any other kind of useful physical parameter may be used.
  • the sensor may comprise a pressure sensor for sensing as the physical parameter a pressure in the patient's body that relates to the pressure in the lumen of the patient's heart.
  • the method suitably comprises operating the control device to control the compression device to change the compression of the patient's wall portion in response to the pressure sensor sensing a predetermined value of measured pressure.
  • a position sensor may be provided for sensing as the physical parameter the orientation of the patient with respect to the horizontal.
  • the position sensor may be a biocompatible version of what is shown in U.S. patents 4 942 668 and 5 900 909.
  • the control device may control the compression device and/or stimulation device to change the compression of the patient's wall portion in response to the position sensor sensing that the patient has assumed a substantially horizontal orientation, i.e. that the patient is lying down.
  • the control device may control the compression device and/or stimulation device to change the compression of the patient's wall portion in response to the time of day.
  • the control device may include a clock mechanism for controlling the compression device and/or stimulation device to change the compression of the patient's wall portion to increase or decrease the influence on the flow in the lumen during different time periods of the day.
  • the clock mechanism is used for controlling the compression device and/or stimulation device provided that the parameter sensed by the sensor does not override the clock mechanism, or the sensor is used for controlling the compression device and/or stimulation device provided that the clock mechanism does not override the sensor.
  • the control device produces an indication, such as a sound signal or displayed information, in response to signals from the sensor.
  • the control device may comprise an implantable internal control unit that directly controls the compression device and/or stimulation device in response to signals from the sensor.
  • the control device may further comprise a wireless remote control adapted to set control parameters of the internal control unit from outside the patient without mechanically penetrating the patient. At least one of the control parameters, which is settable by the wireless remote control, is the physical or functional parameter.
  • the internal control unit includes the above mentioned clock mechanism, wherein the wireless remote control also is adapted to set the clock mechanism.
  • the control device may comprise an external control unit outside the patient's body for controlling the compression device and/or stimulation device in response to signals from the sensor. Compression of Patient's Heart
  • Method step (a) may be performed in many different ways.
  • step (a) may be performed by:
  • step (a) the compression of the wall portion of the heart may be changed either mechanically or hydraulically.
  • step (a) is suitably performed so that the through-flow area of the lumen assumes a size in the compressed state that is small enough to enable the stimulation during step (b) to contract the wall portion of the heart.
  • the method may further comprise implanting in the patient a reservoir containing a predetermined amount of hydraulic fluid, and a compression device engaging the wall portion and having an expandable/contractible cavity, wherein step (a) is performed by distributing hydraulic fluid from the reservoir to increase the volume of the cavity to compresses the wall portion, and by distributing hydraulic fluid from the cavity to the reservoir to decrease the volume of the cavity to release the wall portion.
  • the cavity may be defined by a balloon of the compression device that abuts the tissue wall portion of the patient's heart, so that the patient's wall portion is compressed upon expansion of the cavity and released upon contraction of the cavity.
  • the cavity may be defined by a bellows that displaces a relatively large contraction element of the compression device, for example a large balloon that abuts the wall portion, so that the patient's wall portion is compressed upon contraction of the bellows and released upon expansion of the bellows.
  • a relatively small addition of hydraulic fluid to the bellows causes a relatively large increase in the compression of the wall portion.
  • Such a bellows may also be replaced by a suitably designed piston/cylinder mechanism.
  • the hydraulic means comprises a cavity in the compression device
  • the following embodiments are conceivable.
  • the reservoir comprises first and second wall portions, and step (a) is performed by displacing the first and second wall portions relative to each other to change the volume of the reservoir, so that fluid is distributed from the reservoir to the cavity, or from the cavity to the reservoir.
  • step (a) is performed by displacing the first and second wall portions relative to each other to change the volume of the reservoir, so that fluid is distributed from the reservoir to the cavity, or from the cavity to the reservoir.
  • At least one of a magnetic device, a hydraulic device or an electric control device displaces the first and second wall portions of the reservoir.
  • a pump is provided for pumping fluid between the reservoir and the cavity.
  • the pump comprises a first activation member for activating the pump to pump fluid from the reservoir to the cavity and a second activation member for activating the pump to pump fluid from the cavity to the reservoir.
  • the first and second activation members are operable by manual manipulation thereof.
  • At least one of the activation members operates when subjected to an external predetermined pressure.
  • At least one of the first and second activating members is operable by magnetic means, hydraulic means, or electric control means.
  • a fluid conduit between the pump and the cavity is provided, wherein the reservoir forms part of the conduit.
  • the conduit and pump are devoid of any non-return valve.
  • the reservoir forms a fluid chamber with a variable volume, and the pump distributes fluid from the chamber to the cavity by a reduction in the volume of the chamber and withdraws fluid from the cavity by an expansion of the volume of the chamber.
  • a motor is provided for driving the pump, wherein the pump comprises a movable wall of the reservoir for changing the volume of the chamber.
  • the cavity can be exchanged by a cylinder/piston mechanism for adjusting the compression device.
  • hydraulic fluid is distributed between the reservoir and the cylinder/piston mechanism to adjust the compression device.
  • the method further comprises implanting a reverse servo operatively connected to the hydraulic means.
  • reverse servo is to be understood as a mechanism that transfers a strong force acting on a moving element having a short stroke into a weak force acting on another moving element having a long stroke; i.e., the reverse function of a normal servo mechanism.
  • minor changes in the amount of fluid in a smaller reservoir could be transferred by the reverse servo into major changes in the amount of fluid in a larger reservoir.
  • the reverse servo comprises an expandable servo reservoir containing servo fluid and a fluid supply reservoir hydraulically connected to the servo reservoir to form a closed conduit system for the servo fluid.
  • the expandable servo reservoir has first and second wall portions, which are displaceable relative to each other in response to a change in the volume of the expandable servo reservoir.
  • the first and second wall portions of the servo reservoir are operatively connected to the hydraulic means.
  • the reverse servo distributes fluid between the fluid supply reservoir and the expandable servo reservoir to change the volume of the servo reservoir, whereby the hydraulic means is operated to adjust the compression device.
  • an implantable main reservoir containing a predetermined amount of hydraulic fluid, wherein the reverse servo is operated to distribute hydraulic fluid between the main reservoir and the hydraulic means to adjust the compression device.
  • the main reservoir is provided with first and second wall portions operatively connected to the first and second wall portions of the expandable servo reservoir, so that the volume of the main reservoir is changed when the volume of the expandable servo reservoir is changed.
  • the method comprises dimensioning the servo and main reservoirs, so that when the volume of the servo reservoir is changed by a relatively small amount of servo fluid, the volume of the main reservoir is changed by a relatively large amount of hydraulic fluid.
  • the fluid supply reservoir may have first and second wall portions, which are displaceable relative to each other to change the volume of the fluid supply reservoir to distribute servo fluid between the fluid supply reservoir and the expandable servo reservoir.
  • the first and second wall portions of the fluid supply reservoir may be displaced relative to each other by manual manipulation, a magnetic device, a hydraulic device, or an electric control device to change the volume of the fluid supply reservoir to distribute servo fluid between the fluid supply reservoir and the expandable servo reservoir.
  • the hydraulic means comprises an expandable cavity in the compression device, or in embodiments where the hydraulic means includes a hydraulically operable mechanical construction, the reverse servo described above may be used.
  • the hydraulic means include first and second hydraulically interconnected expandable/contractible reservoirs.
  • the first reservoir is operatively connected to the compression device, so that the compression device changes the compression of the patient's wall portion upon expansion or contraction of the first reservoir.
  • By changing the volume of the second reservoir hydraulic fluid is distributed between the two reservoirs, so that the first reservoir is either expanded or contracted.
  • This embodiment requires no non-return valve in the fluid communication conduits between the two reservoirs, which is beneficial to long-term operation of the hydraulic means.
  • the hydraulic means may include first and second hydraulically interconnected piston/cylinder mechanisms instead of the first and second reservoirs described above.
  • the first piston/cylinder mechanism is operatively connected to the compression device, so that the compression device changes the compression of the patient's wall portion upon operation of the first piston/cylinder mechanism.
  • hydraulic fluid is distributed between the two piston/cylinder mechanisms, so that the first piston/cylinder mechanism adjusts the compression device.
  • the compression device may comprise at least two elongated clamping elements extending along the wall portion on different sides of the heart.
  • the hydraulic means which may include the reverse servo described above, hydraulically moves the elongated clamping elements towards the heart to compress the wall portion of the heart.
  • the compression device may have hydraulic chambers in which the clamping elements slide back and forth, and the hydraulic means may also include a pump and an implantable reservoir containing hydraulic fluid. The pump distributes hydraulic fluid from the reservoir to the chambers to move the clamping elements against the wall portion, and distributes hydraulic fluid from the chambers to the reservoir to move the clamping elements away from the wall portion.
  • step (a) is performed by using the compression device and step (b) is performed by using the stimulation device, wherein the method further comprises forming the compression and stimulation devices in an operable compression/stimulation unit.
  • the method comprises implanting a source of energy, such as a battery, rechargeable battery or accumulator, releasing energy from the source of energy and using the released energy in connection with the operation of the compression/stimulation unit.
  • the method comprises transmitting wireless energy from outside the patient's body to inside the patient's body and using the transmitted wireless energy in connection with the operation of the compression/stimulation unit.
  • the wireless energy may be directly used in connection with the operation of the compression/stimulation unit, as the wireless energy is being transmitted.
  • the wireless energy may be transmitted in the form of an electric, an electromagnetic or a magnetic field, or a combination thereof, or electromagnetic waves for direct power of the compression/stimulation unit.
  • wireless energy in the form of a magnetic or an electromagnetic field may be used for direct power of the motor or pump.
  • the motor or pump is running directly during transmission of the wireless energy.
  • This may be achieved in two different ways: a) using a transforming device implanted in the patient to transform the wireless energy into energy of a different form, preferably electric energy, and powering the motor or pump with the transformed energy, or b) using the wirelessly transmitted energy to directly power the motor or pump.
  • wireless energy in the form of an electromagnetic or magnetic field is used to directly influence specific components of the motor or pump to create kinetic energy.
  • Such components may include coils integrated in the motor or pump.
  • the wireless energy is suitably transmitted in pulses or digital pulses, or a combination of pulses and digital pulses.
  • the wireless energy is transmitted in at least one wireless signal, suitably a wave signal.
  • the wave signal may comprise an electromagnetic wave signal including one of an infrared light signal, a visible light signal, an ultra violet light signal, a laser signal, a microwave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal.
  • the wave signal may comprise a sound or an ultrasound wave signal.
  • the wireless signal may be a digital or analogue signal, or a combination of a digital and analogue signal.
  • the wireless energy is not for direct use in connection with the operation of the compression/stimulation unit.
  • the wireless energy comprises energy of a first form, which is transmitted into energy of a second form suited to operate the compression/stimulation unit.
  • the energy of the second form is different from the energy of the first form.
  • the wireless energy of the first form may comprise sound waves, whereas the energy of the second form may comprise electric energy.
  • one of the energy of the first form and the energy of the second form may comprise magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, photo energy, nuclear energy or thermal energy.
  • one of the energy of the first form and the energy of the second form is non-magnetic, non-kinetic, non-chemical, non-sonic, non- nuclear or non-thermal.
  • an implantable energy-transforming device for transforming wireless energy of a first form transmitted by the energy-transmission device into energy of a second form, which typically is different from the energy of the first form.
  • the compression/stimulation unit is operable in response to the energy of the second form.
  • the wireless energy of the first form may comprise sound waves, whereas the energy of the second form may comprise electric energy.
  • one of the energy of the first form and the energy of the second form may comprise magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, photo energy, nuclear energy or thermal energy.
  • one of the energy of the first form and the energy of the second form is non-magnetic, non-kinetic, non- chemical, non-sonic, non-nuclear or non-thermal.
  • the energy-transforming device may function different from or similar to the energy-transmission device.
  • the energy- transforming device comprises at least one element, such as at least one semiconductor, having a positive region and a negative region, when exposed to the energy of the first form transmitted by the energy-transmission device, wherein the element is capable of creating an energy field between the positive and negative regions, and the energy field produces the energy of the second form.
  • the element may comprise an electrical junction element, which is capable of inducing an electric field between the positive and negative regions when exposed to the energy of the first form transmitted by the energy-transmission device, whereby the energy of the second form comprises electric energy.
  • the energy of the first form may directly or indirectly be transformed into the energy of the second form.
  • the method may comprise providing a motor for operating the compression device and powering the motor with the energy of the second form.
  • the compression device may be operable to perform at least one reversible function and the method may comprise reversing the function by using the motor.
  • the method may comprise shifting the polarity of the energy of the second form to reverse the motor.
  • the motor may be directly powered with the transformed energy, as the energy of the second form is being transformed from the energy of the first form.
  • the compression/stimulation unit is directly operated with the energy of the second form in a non-magnetic, non-thermal or non-mechanical manner.
  • the implanted compression/stimulation unit comprises electric components that are energized with electrical energy. Therefore, the energy of the first form may be transformed into a direct current or pulsating direct current, or a combination of a direct current and pulsating direct current. Alternatively, the energy of the first form may be transformed into an alternating current or a combination of a direct and alternating current.
  • the method may comprise implanting in the patient an internal source of energy, and supplying energy from the internal source of energy for the operation of the compression/stimulation unit.
  • the method may further comprise implanting in the patient a switch operable to switch from an "off' mode, in which the internal source of energy is not in use, to an "on" mode, in which the internal source of energy supplies energy for the operation of the compression/stimulation unit, and/or for energizing implanted electronic components of the compression/stimulation unit.
  • the switch may be operated by the energy of the first form or by the energy of the second form. The described switch arrangement reduces power consumption of the compression/stimulation unit between operations.
  • the internal source of energy may store the energy of the second form.
  • the internal source of energy suitably comprises an accumulator, such as at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.
  • the internal source of energy is a rechargeable battery it may be charged only at times convenient for the patient, for example when the patient is sleeping.
  • the internal source of energy may supply energy for the operation of the compression/stimulation unit but not be used for storing the energy of the second form.
  • the internal source of energy may be a battery and the switch described above may or may not be provided.
  • the method may comprise implanting a stabilizer for stabilizing the energy of the second form.
  • the energy of the second form comprises electric energy
  • the stabilizer suitably comprises at least one capacitor.
  • the energy-transforming device may be designed for implantation subcutaneously in the abdomen, thorax or cephalic region of the patient. Alternatively, it may be designed for implantation in an orifice of the patient's body and under the mucosa or intramuscularly outside the mucosa of the orifice.
  • the compression device is adjustable to enable changing the compression of the patient's wall portion as desired and the control device controls the compression device to change the compression of the wall portion.
  • the method suitably comprises operating the control device by the patient.
  • the control device comprises a manually operable switch for switching on and off the compression/stimulation unit, and the method further comprises subcutaneously implanting the switch in the patient.
  • the control device comprises a handheld wireless remote control operable by the patient from outside the patient's body to control the compression/stimulation unit to adjust the stimulation intensity and/or adjust the compression of the wall portion.
  • the wireless remote control is suitably designed for application on the patient's body like a wristwatch.
  • the wireless remote control preferably transmits at least one wireless control signal for controlling the compression/stimulation unit.
  • the control signal may comprise a frequency, amplitude, phase modulated signal or a combination thereof, and may be an analogue or a digital signal, or a combination of an analogue and digital signal.
  • the remote control may transmit an electromagnetic carrier wave signal for carrying the digital or analogue control signal.
  • the carrier signal may comprise digital, analogue or a combination of digital and analogue signals.
  • Any of the above signals may comprise wave signals, such as a sound wave signal, an ultrasound wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultra violet light signal, a laser light signal, a micro wave signal, a radio wave signal, an x-ray radiation signal or a gamma radiation signal.
  • wave signals such as a sound wave signal, an ultrasound wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultra violet light signal, a laser light signal, a micro wave signal, a radio wave signal, an x-ray radiation signal or a gamma radiation signal.
  • control signal may comprise an electric or magnetic field, or a combined electric and magnetic field.
  • the method may comprise implanting in the patient an operation device, and operating the compression/stimulation unit with the operation device.
  • a magnet may be provided, wherein the method comprises using the magnet to activate the operation device from outside the patient's body.
  • the operation device suitably comprises a motor which is powered with energy released from a source of energy, such as a battery.
  • the present invention also provides a laparoscopic method.
  • a method for controlling a flow of fluid and/or other bodily matter in a lumen formed by a tissue wall of a patient's heart comprises the steps of: inserting a needle like tube into the abdomen of the patients body, filling the abdomen with gas thereby expanding the abdominal cavity, placing at least two laparoscopical trocars in the patient's body, inserting a camera through one of the trocars into the abdomen, inserting a dissecting tool through any of the trocar and dissecting an area of at least one portion of the tissue wall of the heart, placing a compression device and a stimulation device in the dissected area in operative engagement with the heart, using the compression device to gently compress the wall portion of the heart to influence the flow in the lumen, and using the stimulation device to stimulate the compressed wall portion to cause contraction of the wall portion to further influence the flow in the lumen.
  • the method further comprises implanting a powered operation device for operating the compression device.
  • the operation device may comprise a powered hydraulic operation device or an electrically powered operation device, such as an electric motor.
  • the method further comprises transmitting wireless energy for powering the operation device, and when desired to influence the flow in the patient's heart, powering the operation device with the transmitted energy to operate the compression device.
  • the method further comprises implanting a source of energy in the patient, providing an external source of energy, controlling the external source of energy to release wireless energy, transforming the wireless energy into storable energy, such as electric energy, non-invasively charging the implanted source of energy with the transformed energy, and controlling the implanted source of energy from outside the patient's body to release energy for use in connection with the operation of the compression device and/or stimulation device.
  • the wireless energy is transformed into a storable energy different from the wireless energy.
  • the method further comprises providing a source of energy outside the patient's body, controlling the external source of energy from outside the patient's body to release wireless energy, and using the released wireless energy for operating the compression device and/or stimulation device.
  • the wireless energy may be transformed into electrical energy inside the patient's body by an implanted energy-transforming device, wherein the electrical energy is used in connection with the operation of the compression device and/or stimulation device.
  • the electrical energy may be directly used in connection with the operation of the compression device and/or stimulation device, as the transforming device transforms the wireless energy into the electrical energy.
  • the external source of energy may be controlled from outside the patient's body to release non-magnetic wireless energy, wherein the released non-magnetic wireless energy is used for operating the compression device and/or stimulation device.
  • the external source of energy may be controlled from outside the patient's body to release electromagnetic wireless energy, wherein the released electromagnetic wireless energy is used for operating the compression device and/or stimulation device.
  • FIGURES 1A, 1B, 1C, 1D and 1 E schematically illustrate different states of operation of a general embodiment of an apparatus according to the present invention.
  • FIGURES 1 F, 1G and 1 H illustrate different states of operation of a modification of the general embodiment.
  • FIGURES Tl, 1K and 1L illustrate an alternative mode of operation of. the modification of the general embodiment.
  • FIGURE 2 is a longitudinal cross-section of a preferred embodiment of the apparatus including a compression device and an electric stimulation device.
  • FIGURE 3 is a cross-section along line Ill-Ill in FIGURE 2.
  • FIGURE 4 is the same cross-section shown in FIGURE 3, but with the apparatus in a different state of operation.
  • FIGURES 5 shows the apparatus when placed on a heart.
  • FIGURES 6A, 6B and 6C are cross-sections of a modification of the embodiment of FIGURE 2 showing different states of operations with the apparatus applied on a tissue wall of a patient's heart.
  • FIGURES 7A, 7B, 7C and 7D show different embodiments of the apparatus when placed on a heart.
  • FIGURE 8A is a pulse/time diagram showing electric stimulation pulses generated by the apparatus for stimulating a tissue wall of a patient's heart.
  • FIGURE 8B is pulse/time diagram showing a modification of the electric stimulation shown in FIGURE 8A, in which pulses of mixed frequencies and/or amplitudes are employed.
  • FIGURES 9A and 9B show two pulse/time diagrams, respectively, representing electric stimulation of two different areas of the tissue wall with pulses forming pulse trains.
  • FIGURES 1OA and 10B show the pulse/time diagrams of FIGURES 9A and 9B with modified pulse trains.
  • FIGURE 11A is a longitudinal cross-section of an embodiment of the apparatus including a thermal stimulation device, wherein the apparatus is compressing/constricting a tissue wall of a patient's heart.
  • FIGURE 11B is the same embodiment of FIGURE 11A with the thermal stimulation device activated.
  • FIGURE 12A is a schematic view of hydraulic operation means suited for operating the compression device of the embodiments of FIGURES 2-11.
  • FIGURE 12B shows the embodiment of FIGURE 12A with the compression device compressing/constricting a tissue wall of a patient's heart.
  • FIGURE 13A is a schematic view of mechanical operation means suited for operating the compression device of the embodiments of FIGURES 2-11.
  • FIGURE 13B shows the embodiment of FIGURE 13A with the compression device compressing a tissue wall of a patient's heart.
  • FIGURE 13C shows a modification of the embodiment of FIGURE 13B.
  • FIGURE 14 is a cross-sectional view of a reservoir having a variable volume controlled by a remote control motor.
  • FIGURES 15A and 15B are perspective views of a reverse servo.
  • FIGURE 16 is a schematic block diagram illustrating a general embodiment of the apparatus, in which energy is transferred to energy consuming components of the apparatus implanted in the patient.
  • FIGURES 17 to 28 are schematic block diagrams illustrating twelve embodiments, respectively, based on the general embodiment shown in FIGURE 16, wherein wireless energy is transmitted from outside a patient's body to energy consuming components of the apparatus implanted in the patient.
  • FIGURE 29 illustrates an energy-transforming device in the form of an electrical junction element for use in the apparatus of the present invention.
  • FIGURE 30 is a block diagram illustrating control components of an embodiment.
  • FIGURE 31 is a schematic view of exemplary circuitry of an embodiment in which wireless energy is transformed into- a current.
  • FIGURES 1 A, 1 B and 1C schematically illustrate different states of operation of a generally designed apparatus used for practicing the method of the present invention, when the apparatus is applied on a wall portion of a heart designated BO.
  • the apparatus includes a compression device and a stimulation device, which are designated CSD, and a control device designated CD for controlling the compression and stimulation devices CSD.
  • FIGURE 1A shows the apparatus in an inactivation state, in which the compression device does not compress the heart BO and the stimulation device does not stimulate the heart BO.
  • FIGURE 1 B shows the apparatus in a compression state, in which the control device CD controls the compression device to gently compress the wall portion of the heart BO to a compressed state, in which the blood circulation in the compressed wall portion is substantially unrestricted.
  • FIGURE 1 C shows the apparatus in a stimulation state, in which the control device CD controls the stimulation device to stimulate different areas of the compressed wall portion, so that the wall portion of the heart BO contracts (thickens).
  • FIGURES 1 D and 1 E show how the stimulation of the compressed wall portion can be cyclically varied between a first stimulation mode, in which the left area of the wall portion (see FIGURE 1 D) is stimulated, while the right area of the wall portion is not stimulated, and a second stimulation mode, in which the right area of the wall portion (see FIGURE 1 E) is stimulated, while the left area of the wall portion is not stimulated, in order to maintain over time satisfactory blood circulation in the compressed wall portion.
  • the stimulation modes shown in FIGURES 1 D and 1 E only constitute a principle example of how the compressed wall portion of the heart BO may be stimulated. Thus, more than two different areas of the compressed wall portion may be simultaneously stimulated in cycles or successively stimulated.
  • FIGURES 1 F, 1 G and 1 H illustrate different states of operation of a modification of the general embodiment shown in FIGURES 1A-1 E, wherein the compression and stimulation devices CSD include several separate compression/stimulation elements, here three elements CSDE1 , CSDE2 and CSDE3.
  • FIGURE 1 F shows how the element CSDE1 in a first state of operation is activated to both compress and stimulate the heart BO, whereas the other two elements CSDE2 and CSDE3 are inactivated.
  • FIGURE 1G shows how the element CSDE2 in a second following state of operation is activated, whereas the other two elements CSDE1 and CSDE3 are inactivated.
  • FIGURE 1 H shows how the element CSDE3 in a following third state of operation is activated, whereas the other two elements CSDE1 and CSDE2 are inactivated.
  • shifting between the first, second and third states of operation either randomly or in accordance with a predetermined sequence, different portions of the heart can by temporarily compressed and stimulated while maintaining the lumen of the heart closed, whereby the risk of injuring the heart is minimized. It is also possible to activate the elements CSDE1-CSDE3 successively along the heart to move blood.
  • FIGURES 11, 1K and 1L illustrate an alternative mode of operation of the modification of the general embodiment.
  • FIGURE 11 shows how the element CSDE1 in a first state of operation is activated to both compress and stimulate the heart BO, whereas the other two elements CSDE2 and CSDE3 are activated to compress but not stimulate the heart BO.
  • FIGURE 1 K shows how the element CSDE2 in a second following state of operation is activated to both compress and stimulate the heart BO, whereas the other two elements CSDE1 and CSDE3 are activated to compress but not stimulate the heart BO.
  • FIGURE 1L shows how the element CSDE3 in a following third state of operation is activated to both compress and stimulate the heart BO, whereas the other two elements CSDE1 and CSDE2 are activated to compress but not stimulate the heart BO.
  • FIGURES 2-4 show basic components of an embodiment of the apparatus.
  • the apparatus comprises a housing 1 , a compression device 2 arranged in the housing 1 , a stimulation device 3 integrated in the compression device 2, and a control device 4 (indicated in FIGURE 4) for controlling the compression and stimulation devices 2 and 3.
  • the compression device 2 has two elongate clamping elements 5, 6, which are radially movable in the housing 1 towards and away from each other between retracted positions, see FIGURE 3, and clamping positions, see FIGURE 4.
  • the stimulation device 3 includes a multiplicity of electrical elements 7 positioned on the clamping elements 5, 6, so that the electrical elements 7 on one of the clamping elements 5, 6 face the electrical elements 7 on the other clamping element.
  • the compression and stimulation devices form a compression/stimulation unit, in which the compression and stimulation devices are integrated in a single piece.
  • the compression and stimulation devices may also be separate from each other.
  • a structure may be provided for holding the electrical elements 7 in a fixed orientation relative to one another.
  • the electrical elements 7 may include electrodes that are separately attached to the wall portion of the patient's heart.
  • the control device 4 controls the stimulation device 3 to intermittently stimulate each area of the wall portion 8 during successive time periods, wherein each time period is short enough to maintain over time satisfactory blood circulation in the area.
  • control device 4 controls the stimulation of the areas of the wall portion 8, so that each area that currently is not stimulated restores substantially normal blood circulation before it is stimulated again.
  • control device 4 controls the stimulation device 3 to stimulate one or more of the areas at a time and to shift the stimulation from one area to another over time.
  • the control device 4 may control the stimulation device 3 to cyclically propagate the stimulation of the areas along the wall portion 8, for example, in accordance with a determined stimulation pattern.
  • the control device may control the stimulation device to, preferably cyclically, vary the intensity of the stimulation of the wall portion 8..
  • the electrical elements 7 form a series of fourteen groups of electrical elements 7 extending longitudinally along each elongate clamping element 5 and 6, respectively, see FIGURE 2.
  • the electrical elements 7 of each group of electrical elements 7 form a first path of four electrical elements 7 positioned in a row on clamping element 5 and extending tranverse thereto, and a second path of four electrical elements 7 positioned in a row on clamping element 6 and extending tranverse thereto.
  • the two paths of electrical elements 7 extend on mutual sides of the patient's heart.
  • FIGURE 5 illustrate in principle the function of the apparatus according to the present invention.
  • the compression device 1002 is adapted to compress the heart 12 to assist the pump function thereof.
  • the stimulation device 3 is attached to said compression device 1002 and is adapted to stimulate the heart 12 to achieve an additional assistance of said pump function after the compression device 1002 has placed the heart in the compressed state.
  • the compression device 1002 is attached to an arm 1003 which in turn is attached to a mechanical, electrical or hydraulic operating device 1004 which operates the compression device 1002.
  • the operating device 1004 is in turn attached to the sternum 1005 of the human patient with mechanical fixating members such as screws, or adhesive.
  • a control device 4 for controlling the operating device 1004 in accordance with any of the embodiments described in this application is in connection with said operating device 1004 though a connecting member 1006. However it is also conceivable that the control device 4 communicates wirelessly with the operating device 1004.
  • FIGURES 6A - 6C show another embodiment which includes a housing 9 and three elongate clamping elements 10a, 10b, 10c, which are radially movable in the housing 9 towards and away from a central axis thereof between retracted positions, see FIGURE 6A, and clamping positions, see FIGURE 6B.
  • the three clamping elements 10a-10c are symmetrically disposed around the central axis of the housing 9.
  • the stimulation device of this embodiment includes electrical elements 11a, 11 b, 11c that form a series of groups of elements extending longitudinally along the elongate clamping elements 10a-1 Oc, wherein the electrical elements 11a - 11c of each group of electrical elements form a path of three electrical elements 11a, 11b and 11 c extending circumferentially around the central axis of the housing 9.
  • the three electrical elements 11a - 11c of each group are positioned on the three clamping elements 10a-IOc, respectively.
  • the path of three electrical elements 11a-11c extends around the patient's heart.
  • the number of electrical elements 11a-11c of each path of electrical elements can be greater than three, and several parallel rows electrical elements 11a-11c can form each path of electrical elements.
  • FIGURES 7A, 7B, 7C and 7D show one embodiment.
  • the compression/constriction device 1002 could be adapted to provide pressure from one side of the heart 12 such as in fig. 7B or from two different sides of the heart 12 as shown in figs. 7C and 7D. It is conceivable that the compression device 1002 is adapted to compress the heart 12 from the anterior and posterior side, such as in fig. 7C, or from the right and left side of the heart 12 as shown in fig 7B. In the embodiment where the compression is performed from the anterior and posterior side as shown in fig. 7C the operating device 1004 is preferably positioned on an arm 1007 which in turn fixates the device to the patient.
  • the control device 4 controls the stimulation device 3 to energize the electrical elements 7 with electric biphasic pulses, i.e., combined positive and negative pulses.
  • the desired stimulation effect is achieved by varying different pulse parameters.
  • the control device 4 controls the stimulation device 3 to vary the pulse amplitude (voltage), the off time period between successive pulses, the pulse duration and the pulse repetition frequency.
  • the pulse current should be between 1 to 3OmA.
  • a pulse current of about 5mA and a pulse duration of about 300 ⁇ s are suitable, whereas a pulse current of about 2OmA and a pulse duration of about 30 ⁇ s are suitable for muscular stimulation.
  • the pulse repetition frequency suitably is about 10Hz.
  • a pulse combination including a negative pulse PS of short duration and high amplitude (voltage), and a positive pulse PL of long duration and low amplitude following the negative pulse may be cyclically repeated to form a pulse train of such pulse combinations.
  • the energy content of the negative pulse PS should be substantially equal to the energy content of the positive pulse PL.
  • FIGURE 8B is a pulse/time diagram showing a modification of the electric stimulation shown in FIGURE 8A.
  • the pulse combination of FIGURE 8A is mixed with a pulse train combination having a first relatively long pulse train PTL of high frequency/low amplitude pulses, appearing simultaneously with the positive pulse PL of the pulse combination of FIGURE 8A, and a second relatively short pulse train PTS of high frequency/low amplitude appearing simultaneously with the negative pulse PS of the pulse combination shown in FIGURE 8A.
  • the high frequency/low amplitudes pulse trains PTL and PTS are superimposed on the positive and negative pulses PL and PS of FIGURE 8A, as illustrated in FIGURE 8B.
  • the pulse configuration of FIGURE 8B, and variations thereof, is beneficial to use in connection with the stimulation of human hearts, in order to achieve the desired stimulation effect.
  • the electric pulses form pulse trains, as illustrated in the Pulse/time diagrams P/t of FIGURES 9A, 9B.
  • the Pulse/time diagram P/t of FIGURE 9A represents an individual area of the wall portion of the patient's heart which is stimulated with a pulse train.
  • the pulse train includes three initial negative pulses, each of which is of short duration and high amplitude (voltage), and one positive pulse of long duration and low amplitude following the negative pulses. After a delay to enable the area of the heart to restore substantially normal blood circulation, the pulse train is repeated.
  • the Pulse/time diagram P/t of FIGURE 9B represents another individual area of the wall portion, which is stimulated with a pulse train having the same configuration as the pulse train.
  • the pulse trains are shifted relative to each other, so that they partially overlap one another to ensure that the compressed wall portion always is stimulated to contract as desired.
  • the pulse/time diagrams P/t of FIGURES 10A and 10B represent two different areas of the wall portion, which are stimulated with cyclically repeated pulse trains.
  • Each pulse train includes two initial negative pulses, each of which is of short duration and high amplitude (voltage), and one positive pulse of long duration and low amplitude following the two negative pulses.
  • the pulse trains are shifted relative to each other, so that they do not overlap each other.
  • the off time period between adjacent pulse trains is longer than the duration of pulse train and the off time period between adjacent pulse trains is longer than the duration of pulse train.
  • FIGURES 11A and 11B show another embodiment that controls blood flow in a blood vessel 19, comprising a compression device with two clamping elements 20a and 20b, a stimulation device in the form of two thermal stimulation elements 21a and 21b integrated in the clamping elements 20a, 20b, respectively, and a control device 4 for controlling the clamping elements 20a, 20b and stimulation elements 21a, 21b.
  • the clamping elements 20a and 20b are movable towards and away from each other in the same manner as described above in connection with the embodiment according to FIGURES 5A-5C.
  • the thermal stimulation elements 21a and 21b which may include Pertier elements, are positioned on the clamping elements 20a, 20b, so that the thermal elements 21a are facing the thermal elements 21 b.
  • FIGURE 11A shows how the clamping elements 20a, 20b constrict the blood vessel 19, so that the blood flow is restricted.
  • FIGURE 11B shows how the control device 4 controls the thermal stimulation elements 21a, 21 b to cool the wall of the blood vessel 19, so that the wall contracts and closes the blood vessel 19. To release the blood vessel 19, the control device 4 controls the thermal stimulation elements 21a, 21 b to heat the wall of the blood vessel 19, so that the wall expands.
  • FIGURES 12A and 12B show hydraulic operation means suited for operating the compression device of the embodiments described above. Specifically, FIGURES 12A and 12B show the apparatus of FIGURE 2 provided with such means for hydraulic operation of the compression device 2. (The stimulation device is not shown.)
  • the housing 1 forms two hydraulic chambers 22a and 22b, in which the two clamping elements 5, 6 are slidable back and forth relative to the tissue wall portion 8 of a patient's heart.
  • the hydraulic operation means include an expandable reservoir 23, such as an elastic balloon, containing hydraulic fluid, conduits 24a and 24b between the reservoir 23 and the hydraulic chambers 22a, 22b, and a two-way pump 25 for pumping the hydraulic fluid in the conduits 24a, 24b.
  • the control device 4 controls the pump 25 to pump hydraulic fluid from the reservoir 23 to the chambers 22a, 22b to move the clamping elements 5, 6 against the wall portion 8, whereby the wall portion 8 is compressed, see FIGURE 12B, and to pump hydraulic fluid from the chambers 22a, 22b to the reservoir 23 to move the clamping elements 5, 6 away from the wall portion 8, whereby the wall 8 is released, see FIGURE 12A.
  • FIGURES 12A and 12B may be manually operated by applying suitable manually operable hydraulic means for distributing the hydraulic fluid between the expandable reservoir 23 and the hydraulic chambers 22a, 22b. In this case the pump 25 is omitted.
  • FIGURES 13A and 13B schematically show a mechanically operable embodiment, comprising a housing 26 applied on the tissue wall portion 8 of a patient's heart, a compression device 27 arranged in the housing 26 and a control device 4 for controlling the compression device 27.
  • a stimulation device (not shown) as described above is also provided in the housing 26.
  • the compression device 27 includes a clamping element 28, which is radially movable in the housing 26 towards and away from the wall portion 8 between a retracted position, see FIGURE 13A, and a clamping position, see FIGURE 13B, in which the clamping element 28 gently compresses the wall portion 8.
  • Mechanical operation means for mechanically operating the clamping element 28 includes an electric motor 29 attached to the housing 26 and a telescopic device 30, which is driven by the motor 29 and operatively connected to the clamping element 28.
  • the control device 4 controls the electric motor 29 to expand the telescopic device 30 to move the clamping element 28 against the wall portion 8, whereby the wall portion 8 is compressed, see FIGURE 13B, and controls the motor 29 to retract the telescopic device 30 to move the clamping element 28 away from the wall portion 8, whereby the wall portion 8 is released, see FIGURE 13A.
  • stimulation devices may be provided to form compression/stimulation units, in which the stimulation devices include a multiplicity of electrical elements 7 (indicated in FIGURE 12A) positioned on the compression devices.
  • FIGURE 14 is a cross-sectional view of a fluid supply device including a bellows reservoir 80 defining a chamber 81 , the size of which is variable by an operation device comprising a remote controlled electric motor 82.
  • the reservoir 80 and the motor 82 are placed in a housing 83. Moving a large wall 84 varies the chamber 81.
  • the wall 84 is secured to a nut 85, which is threaded on a rotatable spindle 86.
  • the spindle 86 is rotated by the motor 82.
  • a battery 89 placed in the housing 83 powers the motor 82.
  • a signal receiver 90 for controlling the motor 82 is also placed in the housing 83. Alternatively, the battery 89 and the signal receiver 90 may be mounted in a separate place.
  • the motor 82 may also be powered with energy transferred from transmitted signals.
  • the fluid supply device of FIGURE 14 may be used for supplying hydraulic fluid for the operation of the compression devices described in this specification.
  • the fluid supply device of FIGURE 14 may be substituted for a reservoir.
  • FIGURES 15A and 15B show a reverse servo including a rectangular housing 91 and an intermediate wall 92, which is movable in the housing 91.
  • a relatively large, substantially cylindrical bellows reservoir 93 is arranged in the housing 91 and is joined to the movable intermediate wall 92.
  • Another cylindrical bellows reservoir 94 which is substantially smaller than reservoir 93, is arranged in the housing 91 at the other side of the intermediate wall 92 and is also joined to the wall 92.
  • the small bellows reservoir 94 has a fluid supply pipe 95 and the large bellows reservoir 93 has a fluid supply pipe 96.
  • FIGURE 15A when a small amount of hydraulic fluid is conducted through the supply pipe 95 into the small bellows reservoir 94, the small bellows reservoir 94 expands and pushes the movable intermediate wall 92 towards the large bellows reservoir 93. As a result, the large bellows reservoir 93 is contracted by the intermediate wall 92, whereby a large amount of hydraulic fluid is forced out of the large bellows reservoir 93 through the supply pipe 96, as shown in FIGURE 15B.
  • FIGURE 16 schematically shows a general embodiment of the apparatus, in which energy is transferred to energy consuming components of the apparatus implanted in the patient.
  • the apparatus of FIGURE 16 comprises an implanted compression/stimulation unit 110, which is operable to gently compress a portion of a tissue wall of a patient's heart and to stimulate different areas of the compressed portion to cause contraction of the wall portion.
  • a source of energy 111 is adapted to supply energy consuming components of the compression/stimulation unit 110 with energy via a power supply line 112.
  • a wireless remote control or a subcutaneously implanted switch operable by the patient to switch on or off the supply of energy from the source of energy may be provided.
  • the source of energy may be an implantable permanent or rechargeable battery, or be included in an external energy-transmission device, which may be operable directly by the patient or be controlled by a remote control operable by the patient to transmit wireless energy to the energy consuming components of the compression/stimulation unit.
  • the source of energy may comprise a combination of an implantable rechargeable battery, an external energy-transmission device and an implantable energy-transforming device for transforming wireless energy transmitted by the external energy- transmission device into electric energy for the charge of the implantable rechargeable battery.
  • FIGURE 17 shows a special embodiment of the general embodiment of FIGURE 16 having some parts implanted in a patient and other parts located outside the patient's body.
  • An implanted energy-transforming device 111A of the apparatus is adapted to supply energy consuming components of the compression/stimulation unit 110 with energy via the power supply line 112.
  • An external energy-transmission device 113 of the apparatus includes a wireless remote control transmitting a wireless signal, which is received by a signal receiver incorporated in the implanted energy-transforming device 111A.
  • the implanted energy- transforming device 111A transforms energy from the signal into electric energy, which is supplied via the power supply line 112 to the compression/stimulation unit 110.
  • the apparatus of FIGURE 17 may also include an implanted rechargeable battery for energizing energy consuming implanted components of the apparatus.
  • the implanted energy-transforming device 111A also charges the battery with electric energy, as the energy-transforming device transforms energy from the signal into the electric energy.
  • a reversing device in the form of an electric switch 114 such as a microprocessor, is implanted in the patient for reversing the compression device of the compression/stimulation unit 110.
  • the wireless remote control of the external energy-transmission device 113 transmits a wireless signal that carries energy and the implanted energy-transforming device 111A transforms the wireless energy into a current for operating the switch 114.
  • the switch 114 reverses the function performed by the compression device of the compression/stimulation unit 110.
  • FIGURE 18 shows an embodiment including the energy- transforming device 111A, the compression/stimulation unit 110 and an implanted operation device in the form of a motor 115 for operating the compression device of the compression/stimulation unit 110.
  • the motor 115 is powered with energy from the energy-transforming device 111A, as the remote control . of the external energy-transmission device113 transmits a wireless signal to the receiver of the energy-transforming device 111 A.
  • FIGURE 19 shows an embodiment including the energy- transforming device 111A, the compression/stimulation unit 110 and an implanted assembly 116 including a motor/pump unit 117 and a fluid reservoir 118.
  • the compression device of the compression/stimulation unit 110 is hydraulically operated, i.e., hydraulic fluid is pumped by the motor/pump unit 117 from the reservoir 118 to the compression/stimulation unit 110 to compressed the wall portion, and hydraulic fluid is pumped by the motor/pump unit 117 back from the compression/stimulation unit 110 to the reservoir 118 to release the wall portion.
  • the implanted energy-transforming device 111A transforms wireless energy into a current, for powering the motor/pump unit 117.
  • FIGURE 20 shows an embodiment comprising the external energy-transmission device 113.that controls the control unit 122 to reverse the motor 115 when needed, the compression/stimulation unit 110, the compression device of which is hydraulically operated, and the implanted energy-transforming device 111A, and further comprising an implanted hydraulic fluid reservoir 119, an implanted motor/pump unit 120, an implanted reversing device in the form of a hydraulic valve shifting device 121 and a separate external wireless remote control 111 B.
  • the motor of the motor/pump unit 120 is an electric motor.
  • the implanted energy-transforming device 111A powers the motor/pump unit 120 with energy from the energy carried by the control signal, whereby the motor/pump unit 120 distributes hydraulic fluid between the reservoir 119 and the compression device of the compression/stimulation unit 110.
  • the remote control 111B controls the shifting device 121 to shift the hydraulic fluid flow direction between one direction in which the fluid is pumped by the motor/pump unit 120 from the reservoir 119 to the compression device of the compression/stimulation unit 110 to compressed the wall portion, and another opposite direction in which the fluid is pumped by the motor/pump unit 120 back from the compression device of the compression/stimulation unit 110 to the reservoir 119 to release the wall portion.
  • FIGURE 21 shows an embodiment including the energy- transforming device 111 A and the compression/stimulation unit 110.
  • a control unit 122, an accumulator 123 and a capacitor 124 are also implanted in the patient.
  • a separate external wireless remote control 111 B controls the control unit 122.
  • the control unit 122 controls the energy-transforming device 11 IA to. store electric energy in the accumulator 123, which supplies energy to the compression/stimulation unit 110.
  • control unit 122 In response to a control signal from the wireless remote control 111 B, the control unit 122 either releases electric energy from the accumulator 123 and transfers the released energy via power lines, or directly transfers electric energy from the energy-transforming device 111A via the capacitor 124, which stabilises the electric current, for the operation of the compression/stimulation unit 110.
  • FIGURE 22 shows an embodiment including the energy- transforming device 111A, the compression/stimulation unit 110.
  • the 126 is operated by the energy supplied by the energy-transforming device 111A to switch from an off mode, in which the battery 125 is not in use, to an on mode, in which the battery 125 supplies energy for the operation of the compression/stimulation unit 110.
  • FIGURE 23 shows an embodiment identical to that of FIGURE
  • FIGURE 24 shows an embodiment identical to that of FIGURE
  • the implanted control unit 122 controls the switch 126 to switch from an off mode, in which the accumulator 123 is not in use, to an on mode, in which the accumulator 123 supplies energy for the operation of the compression/stimulation unit 110.
  • FIGURE 25 shows an embodiment identical to that of FIGURE
  • the implanted control unit 122 controls the accumulator 123, which may be a capacitor, to deliver energy for operating the switch 126 to switch from an off mode, in which the battery 125 is not in use, to an on mode, in which the battery 125 supplies electric energy for the operation of the compression/stimulation unit 110.
  • the accumulator 123 which may be a capacitor
  • the switch 126 may be operated by energy supplied by the accumulator 123 to switch from an off mode, in which the wireless remote control 111 B is prevented from controlling the battery 125 to supply electric energy and the battery 125 is not in use, to a standby mode, in which the wireless remote control 111B is permitted to control the battery 125 to supply electric energy for the operation of the compression/stimulation unit. 110.
  • FIGURE 26 shows an embodiment identical to that of FIGURE 22, except that a motor 115, a mechanical reversing device in the form of a gearbox 127 and a control unit 122 for controlling the gearbox 127 also are implanted in the patient.
  • a separate external wireless remote control 111 B controls the implanted control unit 122 to control the gearbox 127 to reverse the function performed by the compression device (mechanically operated) of the compression/stimulation unit 110.
  • FIGURE 27 shows an embodiment identical to that of FIGURE 25, except that the implanted components are interconnected differently.
  • the battery 125 powers the control unit 122 when the accumulator 123, suitably a capacitor, activates the switch 126 to switch to an on mode.
  • the control unit 122 is permitted to control the battery 125 to supply, or not supply, energy for the operation of the compression/stimulation unit 110.
  • FIGURE 28 shows an embodiment identical to that of FIGURE 18, except that a gearbox 127 that connects the motor 115 to the compression/stimulation unit 110, and a control unit 122 that controls the energy-transforming device 111A to power the motor 115 also are implanted in the patient. There is a separate external wireless remote control 111 B that controls the control unit 122 to reverse the motor 115 when needed.
  • the accumulator 123 shown in FIGURE 21 may be provided in the embodiment of FIGURE 28, wherein the implanted control unit
  • control unit 122 controls the energy-transforming device 111A to store the transformed energy in the accumulator 123. In response to a control signal from the wireless remote control 111B, the control unit 122 controls the accumulator
  • the energy operated switch 114 could be incorporated in any of the embodiments of FIGURES 18, 21-28, the hydraulic shifting device 121 could be incorporated in the embodiment of FIGURE 19, and the gearbox 127 could be incorporated in the embodiment of FIGURE 18.
  • the switch 114 may be of a type that includes electronic components, for example a microprocessor, or a FGPA (Field Programmable Gate Array) designed for switching.
  • the energy operated switch 114 may be replaced by a subcutaneously implanted push button that is manually switched by the patient between "on" and'Off”.
  • a permanent or rechargeable battery may be substituted for the energy-transforming devices 111A of the embodiments shown in FIGURES 17-28.
  • FIGURE 29 shows the energy-transforming device in the form of an electrical junction element 128 for use in any of the above embodiments according to FIGURES 16-28.
  • the element 128 is a flat p-n junction element comprising a p-type semiconductor layer 129 and an n-type semiconductor layer 130 sandwiched together.
  • a light bulb 131 is electrically connected to opposite sides of the element 128 to illustrate how the generated current is obtained.
  • the output of current from such a p-n junction element 128 is correlated to the temperature. See the formula below.
  • I IO (exp(qV/kT)-1 )
  • I the external current flow
  • IO the reverse saturation current
  • q the fundamental electronic charge of 1.602 x 10-19 coulombs
  • V the applied voltage
  • k the Boltzmann constant
  • T the absolute temperature
  • the alternative way to design a p-n junction element is to deposit a thin layer of semiconductor onto a supporting material which does not absorb the kind of energy utilised in the respective embodiments.
  • a supporting material which does not absorb the kind of energy utilised in the respective embodiments.
  • glass could be a suitable material.
  • Various materials may be used in the semiconductor layers, such as, but not limited to, cadmium telluride, copper-indium-diselenide and silicon. It is also possible to use a multilayer structure with several layers of p and n-type materials to improve efficiency.
  • the electric energy generated by the p-n junction element 128 could be of the same type as generated by solar cells, in which the negative and positive fields create a direct current.
  • the negative and positive semiconductor layers may change polarity following the transmitted waves, thereby generating the alternating current.
  • the p-n junction element 128 is designed to make it suited for implantation. Thus, all the external surfaces of the element 128 in contact with the human body are made of a biocompatible material.
  • the p-n junction semiconductors are designed to operate optimally at a body temperature of 37°C because the current output, which should be more than 1 ⁇ A, is significantly dependent upon such temperature, as shown above. Since both the skin and subcutis absorb energy, the relation between the sensitivity or working area of the element 128 and the intensity or strength of the wireless energy-transmission is considered.
  • the p-n junction element 128 preferably is designed flat and small. Alternatively, if the element 128 is made in larger sizes it should be flexible, in order to adapt to the patient's body movements.
  • FIGURE 30 shows basic parts of a remote control of the apparatus for controlling the compression/stimulation unit 110.
  • the stimulation device of the compression/stimulation unit stimulates the wall portion with electric pulses.
  • the remote control is based on wireless transmission of electromagnetic wave signals, often of high frequencies in the order of 100 kHz - 1 gHz, through the skin 132 of the patient.
  • all parts placed to the left of the skin 132 are located outside the patient's body and all parts placed to the right of the skin 132 are implanted.
  • An external signal-transmission device 133 is to be positioned close to a signal-receiving device 134 implanted close to the skin 132.
  • the signal-receiving device 134 may be placed for example inside the abdomen of the patient.
  • the signal-receiving device 134 comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter, wound with a very thin wire and tuned with a capacitor to a specific high frequency. A small coil is chosen if it is to be implanted under the skin of the patient and a large coil is chosen if it is to be implanted in the abdomen of the patient.
  • the signal transmission device 133 comprises a coil having about the same size as the coil of the signal-receiving device 134 but wound with a thick wire that can handle the larger currents that is necessary.
  • the coil of the signal transmission device 133 is tuned to the same specific high frequency as the coil of the signal-receiving device 134.
  • the signal-transmission device 133 is adapted to send digital information via the power amplifier and signal-receiving device 134 to an implanted control unit 135. To avoid that accidental random high frequency fields trigger control commands, digital signal codes are used. A conventional keypad placed on the signal transmission device 133 is used to order the signal transmission device 133 to send digital signals for the control of the compression/stimulation unit.
  • the signal transmission device 133 starts a command by generating a high frequency signal. After a short time, when the signal has energized the implanted parts of the control system, commands are sent to operate the compression device of the compression/stimulation unit 110 in predefined steps. The commands are sent as digital packets in the form illustrated below. Start pattern 8 bits, Command 8 bits, Count 8 bits, Checksum 8 bits.
  • the commands are sent continuously during a rather long time period (e.g., about 30 seconds or more).
  • a rather long time period e.g., about 30 seconds or more.
  • the Count byte is increased by one to allow the implanted control unit 135 to decode and understand that another step is demanded by the signal transmission device 133. If any part of the digital packet is erroneous, its content is simply ignored.
  • an implanted energizer unit 137 draws energy from the high frequency electromagnetic wave signals received by the signal-receiving device 134.
  • the energizer unit 137 stores the energy in a source of energy, such as a large capacitor, powers the control unit 135 and powers the compression/stimulation unit 110 via a line 138.
  • the control unit 135 comprises a demodulator and a microprocessor.
  • the demodulator demodulates digital signals sent from the signal transmission device 133.
  • the microprocessor receives the digital packet, decodes it and sends a control signal via a signal line 139 to control the compression device of the compression/stimulation unit 110 to either compress or release the wall portion of the patient's heart depending on the received command code.
  • FIGURE 52 shows a circuitry of an embodiment, in which wireless energy is transformed into a current.
  • External components of the circuitry include a microprocessor 140, a signal generator 141 and a power amplifier 142 connected thereto.
  • the microprocessor 140 is adapted to switch the signal generator 141 on/off and to modulate signals generated by the signal generator 141 with digital commands.
  • the power amplifier 142 amplifies the signals and sends them to an external signal-transmitting antenna coil 143.
  • the antenna coil 143 is connected in parallel with a capacitor 144 to form a resonant circuit tuned to the frequency generated by the signal generator 141.
  • Implanted components of the circuitry include a signal receiving antenna coil 145 and a capacitor 146 forming together a resonant circuit that is tuned to the same frequency as the transmitting antenna coil 143.
  • the signal receiving antenna coil 145 induces a current from the received high frequency electromagnetic waves and a rectifying diode 147 rectifies the induced current, which charges a storage capacitor 148.
  • the storage capacitor 148 powers a motor 149 for driving the compression device of the compression/stimulation unit 110.
  • a coil 150 connected between the antenna coil 145 and the diode 147 prevents the capacitor 148 and the diode 147 from loading the circuit of the signal-receiving antenna 145 at higher frequencies.
  • a capacitor 151 and a resistor 152 connected in parallel and a diode 153 form a detector used to detect amplitude modulated digital information.
  • a filter circuit is formed by a resistor 154 connected in series with a resistor 155 connected in series with a capacitor 156 connected in series with the resistor 154 via ground, and a capacitor 157, one terminal of which is connected between the resistors 154,155 and the other terminal of which is connected between the diode 153 and the circuit formed by the capacitor 151 and resistor 152.
  • the filter circuit is used to filter out undesired low and high frequencies.
  • the detected and filtered signals are fed to an implanted microprocessor 158 that decodes the digital information and controls the motor 149 via an H-bridge 159 comprising transistors 160, 161 , 162 and 163.
  • the motor 149 can be driven in two opposite directions by the H-bridge 159.
  • the microprocessor 158 also monitors the amount of stored energy in the storage capacitor 148. Before sending signals to activate the motor 149, the microprocessor 158 checks whether the energy stored in the storage capacitor 148 is enough. If the stored energy is not enough to perform the requested operation, the microprocessor 158 waits for the received signals to charge the storage capacitor 148 before activating the motor 149.
  • the energy stored in the storage capacitor 148 may only be used for powering a switch, and the energy for powering the motor 149 may be obtained from another implanted energy source of relatively high capacity, for example a battery.
  • the switch is adapted to connect the battery to the motor 149 in an on mode when the switch is powered by the storage capacitor 148 and to keep the battery disconnected from the motor 149 in a standby mode when the switch is not powered.

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Abstract

La présente invention concerne un procédé permettant de réguler la circulation sanguine dans une lumière formée par une paroi tissulaire dans le coeur d'un patient. Le procédé consiste à comprimer légérement au moins une partie de la paroi tissulaire (c'est-à-dire sans entraver sensiblement la circulation sanguine dans la paroi tissulaire) afin d'agir sur la circulation dans la lumière, puis à stimuler la partie de la paroi comprimée pour provoquer la contraction de cette partie de paroi, afin d'agir davantage sur la circulation dans la lumière. Il est possible de mettre en oeuvre ledit procédé pour restreindre ou stopper la circulation dans la lumière ou pour déplacer activement le sang dans la lumière, avec un faible risque de lésion du coeur.
PCT/SE2008/000566 2007-10-11 2008-10-10 Procédé d'aide à la circulation dans le coeur WO2009048377A1 (fr)

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