WO2009048397A1

WO2009048397A1 - Method for assisting flow in a heart

Info

Publication number: WO2009048397A1
Application number: PCT/SE2008/000591
Authority: WO
Inventors: Peter Forsell
Original assignee: Milux Holding Sa
Priority date: 2007-10-11
Filing date: 2008-10-13
Publication date: 2009-04-16

Abstract

There is provided a method for controlling a flow of blood in a lume formed by a tissue wall of a patient's heart. The method comprises gently compressing (i.e., without substantially hampering the blood circulation in the tissue wall) at least one portion of the tissue wall to influence the flow in the lumen, and stimulating the compressed wall portion to cause contraction of the wall portion to further influence the flow in the lumen. The method can be used for restricting or stopping the flow in the lumen, or for actively moving the blood in the lumen, with a low risk of injuring the heart.

Description

TITLE OF THE INVENTION

METHOD FOR ASSISTING FLOW IN A HEART

TECHNICAL FIELD

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 life-saving methods and can only be used to alleviate acute heart failures.

However, long lasting heart failure is ever increasing, despite the advancements in cardiology. Implantable mechanical heart compression devices could potentially provide treatment for many patients suffering from a failing heart.

Over the years several mechanical heart compression devices for implantation have been developed. In US 5119804 Anstadt describes a cardiac massage apparatus that comprises a cup adapted to fit loosely over the lower portion of the heart, wherein the inner of the cup forms a diaphragm that compresses the heart using alternating positive and negative pressure.

In US 5713954 Rosenberg describes a cup fitted around the heart. The cup comprises tubular segments connected to each other so that they form a cuff.

The tubes are sealed for purpose of inflation or deflation using pneumatic force or hydraulic fluid. The alternating inflation and deflation of the tubes compresses the heart and assists the pumping.

In US 5749839 Kovacs further develops Anstadt's cup by having two independently operable diaphragms inside of the cup.

The above described prior art all use different kinds of mechanical elements which all have acommon dissadvantage in that hard fibrosis may form around the mechanical element over time and may cause malfunction of the said mechanical element. Thus, the formed fibrosis may sooner or later become a hard fibrotic layer which may make it difficult for the mechanical element to work.

Another more serious disadvantage is that the element that compresses the heart muscle may injure the tissue wall of the heart. Thus, a consequence of the element's compressing action on the heart is that the mechanical element might erode into the heart over time, and in a worst case, penetrate the wall portion of the heart. In addition, 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. However, 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. Such a large power supply would necessitate the implantation of a very large, high capacity battery and/or a sophisticated system for continuous wireless transmission of energy from outside the patient's body for frequent charging of an implanted rechargeable battery. Thus, because of its large size and high power consumption, the apparatus would be impractical or even unrealistic. Finally, a sophisticated control system would be necessary to control the moving elements. SUMMARY

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.

[0004] In accordance with this object of the present invention, there is provided a method for controlling the flow of blood in a lumen that is formed by the tissue wall of a heart, the method comprising:

[0005] a) gently compressing a portion of the wall to influence the flow in the heart, and

[0006] b) stimulating the compressed wall portion to cause contraction of the wall portion to further influence the flow in the heart.

[0007] 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. Thus, 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.

[0008] Preferably, 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.

[0009] 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. Preferably, 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.

[0010] Initially, 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.

[0011] 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.

[0012] When using the method in accordance with the first or second options, 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.

[0013] 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.

[0014] Furthermore, when using the method, 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. For example, 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. In particular, 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. Such a sensor may for example sense the pressure against the implanted compression device or the pressure on the tissue wall of the heart. [0015] In some applications of the method, continuous stimulation may over time change the physical properties of the tissue so that the tissue might be injured. Also, the effect of a continuous stimulation of the tissue wall may decrease over time. Therefore, 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. Advantageously, 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. Thus, 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.

[0016] To maintain satisfactory blood circulation in the tissue wall of the patient's heart 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. Preferably, 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. [0017] 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.

[0018] Generally, 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. [0019] 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. Specifically, step (a) may be performed by compressing all of the wall portions of the series of wall portions, and step (b) may be performed by stimulating any compressed wall portions in random or in accordance with a predetermined sequence. Moving blood

[0020] The method of the present invention can be practised for actively moving the blood in lumen of a patient's heart. Thus, in the embodiments listed below, steps (a) and (b) are co-operated to move the blood in the lumen.

[0021] 1) Step (a) is performed by compressing the wall portion, and 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.

[0022] 2) Step (a) is performed by compressing the wall portion, and 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.

[0023] 3) Step (a) is performed by varyingly compressing the wall portion to vary the flow in the lumen, and 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.

[0024] 4) 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.

[0025] 5) 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.

[0026] 5a) In accordance with an alternative, 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. [0027] 5b) In accordance with another alternative, 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. Suitably, the method further comprises cyclically moving the compression elements one after the other along the wall portions of the series of wall portions. Specifically, 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.

[0028] 6) 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.

[0029] 7) Step (a) is performed by compressing wall portions of a series of wall portions, and 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.

[0030] 8) 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. Optionally, the method further comprises stimulating the wall portion between the upstream and downstream ends thereof, as (c) is performed. [0031] 8a) In accordance with an alternative, step (a) is performed by compressing the wall portion at the upstream end, and 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. [0032] 8b) In accordance with another alternative, step (a) is performed by compressing the wall portion at the downstream end, and 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.

[0033] In any of the above noted embodiments (1) to (8b), step (b) may be performed by stimulating the wall portion with electric pulses.

Stimulation Modes

[0034] When stimulating neural or muscular tissue there is a risk of injuring or deteriorating the tissue over time if the stimulation is not properly performed. The method of the present invention is performed to reduce or even eliminate that risk. Thus, 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. In addition, 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. Furthermore, 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. This gives the advantage that the method of the present invention provides continuous stimulation of the wall portion of the heart to achieve the desired flow control while essentially maintaining over time the natural physical properties of the heart without risk of injuring the heart.

[0035] Also, by physically changing the places of stimulation on the heart over time as described above it is possible to create an advantageous changing stimulation pattern on the heart, in order to achieve a desired flow control.

[0036] To achieve the desired reaction of the tissue wall during the stimulation thereof, step (b) may be performed by stimulating the wall portion with, preferably cyclically, varying stimulation intensity. [0037] In an embodiment, 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. Thus, 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. Also 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. Furthermore, the repetition frequency of the pulses of the pulse trains and the length and number of pulses of each pulse train may be varied. [0038] As mentioned above, for reasons of maintaining over time the effect of stimulation, it is preferable that different areas of the wall portion are intermittently and individually stimulated. In consequence, 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. In case the off time periods between pulse trains that stimulate the respective area of the wall portion are varied, it is preferable that 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.

Electric Stimulation

[0039] In accordance with an embodiment, 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. Thus, 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. Of course, 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.

[0040] In accordance with the preferred embodiment, 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. Optionally, 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.

[0041] 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. Optionally, 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.

[0042] 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. Alternatively, 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.

[0043] In an embodiment, 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. In a first alternative, 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. Alternatively, 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. For example, 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.

Thermal Stimulation

[0044] In accordance with an embodiment, stimulation step (b) is performed by thermally stimulating the wall portion. Thus, the wall portion may be cooled, when the wall portion is compressed, to cause contraction of the wall portion. For example, the wall portion may be compressed, and the compressed wall portion may be cooled to cause contraction thereof. Alternatively, the wall portion may be heated, when the wall portion is compressed and contracted, to cause expansion of the wall portion. Where the wall portion includes a blood vessel, the blood vessel may be cooled to cause contraction thereof, or heated to cause expansion thereof. Where applicable, thermal stimulation may be practised in any of the embodiments of the present invention. Where applicable, 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.

Compression and Stimulation Devices

[0045] Generally, 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 tne 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. Suitably, the control device comprises a hand-held wireless remote control operated by the patient.

[0046] Alternatively, the control device comprises a manually operable switch for switching on and off the compression device and/or stimulation device. In this case, the method comprises subcutaneously implanting the switch in the patient and manually operating the the implanted switch from outside the patient's body.

[0047] In an embodiment, 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. In this case, 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.

[0048] Sensor Controlled Compression and/or Stimulation

[0049] In an embodiment, 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. Generally, 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.

[0050] Many different kinds of sensor for sensing physical parameters may be used. For example motion sensors for sensing heart motion, i.e. natural contractions, such as stomach or intestinal contractions, pressure sensors for sensing pressure in the heart, 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, oxygen-sensors sensors for sensing the oxygen content of the fluid in the lumen of the heart, or 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. [0051] Many different kinds of sensors that sense functional parameters of implanted components may also be used for the control of the compression device and/or the stimulation device. For example sensors for sensing electric parameters of implanted electric components, or sensors for sensing the performance of implanted motors or the like. [0052] 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. In this case, 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. [0053] Alternatively, or in combination with the pressure sensor, 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. For example, 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. [0054] The above described sensors may be used in any of the embodiments, where applicable.

[0055] 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. For that purpose 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. In case a sensor of any of the above-described types for sensing a physical or functional parameter is provided, either 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. Suitably, the control device produces an indication, such as a sound signal or displayed information, in response to signals from the sensor.

[0056] 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. Suitably, the internal control unit includes the above mentioned clock mechanism, wherein the wireless remote control also is adapted to set the clock mechanism. Alternatively, 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

[0057] Method step (a) may be performed in many different ways.

Thus, step (a) may be performed by: (1) - bending the wall portion;

(2) - clamping the wall portion between at least two elements positioned on different sides of the heart;

(3) - clamping the heart between an element and the bone or tissue of the patient;

(4) - rotating at least two elements positioned on different sides of the heart; or

(5) - clamping the heart between at least two articulated clamping elements positioned on different sides of the heart.

[0061] In the above noted alternatives (1) to (5) of method step (a), the compression of the wall portion of the heart may be changed either mechanically or hydraulically. For many applications of the present invention, 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. [0062] Where the compression of the wall portion is hydraulically changed, 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.

[0063] Alternatively, 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. Thus, 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.

[0064] Where the hydraulic means comprises a cavity in the compression device, the following embodiments are conceivable.

[0065] 1) 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.

[0066] 1a) 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.

[0067] 2) A pump is provided for pumping fluid between the reservoir and the cavity.

[0068] 2a) 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.

[0069] 2a1 ) The first and second activation members are operable by manual manipulation thereof.

[0070] 2a2) At least one of the activation members operates when subjected to an external predetermined pressure.

[0071] 2a3) At least one of the first and second activating members is operable by magnetic means, hydraulic means, or electric control means. [0072] 2b) 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.

[0073] In all of the above noted embodiments 1 to 2b where the hydraulic means comprises an expandable cavity in the compression device, the cavity can be exchanged by a cylinder/piston mechanism for adjusting the compression device. In this case, hydraulic fluid is distributed between the reservoir and the cylinder/piston mechanism to adjust the compression device.

[0074] 3) The method further comprises implanting a reverse servo operatively connected to the hydraulic means. The term "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. Thus, 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.

[0075] Preferably, 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.

[0076] In accordance with a first alternative, 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.

[0077] In accordance with a second alternative, there is provided 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. More specifically, 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. Thus, when the reverse servo distributes servo fluid between the fluid supply reservoir and the expandable servo reservoir to change the volume of the main reservoir, hydraulic fluid is distributed from the main reservoir to the hydraulic means, or from the hydraulic means to the main reservoir. Advantageously, 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. [0078] In both of the above-described alternatives, 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.

[0079] In all of the above noted embodiments 1 to 2b where 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. In a further embodiment, 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.

[0080] Alternatively, 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. By operating the second piston/cylinder mechanism hydraulic fluid is distributed between the two piston/cylinder mechanisms, so that the first piston/cylinder mechanism adjusts the compression device.

[0081] Where the compression device does not include an expandable/contractible cavity, 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. For example, 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.

Energy Supply

[0082] Generally, method 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. [0083] In a simple form, 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. [0084] In a more sophisticated form, which is preferable, 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.

Transmission of Wireless Energy

SUBSTITUTE SHEETJRULE 26) [0085] The wireless energy may be directly used in connection with the operation of the compression/stimulation unit, as the wireless energy is being transmitted. For example, 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. For example, where an electric motor or pump operates the compression device 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.

[0086] Thus, 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. Preferably 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. [0087] The wireless energy is suitably transmitted in pulses or digital pulses, or a combination of pulses and digital pulses. [0088] Preferably, 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. Alternatively, 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.

[0089] In accordance with a particular embodiment, the wireless energy is not for direct use in connection with the operation of the compression/stimulation unit. In this embodiment 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. Typically, the energy of the second form is different from the energy of the first form. For example, the wireless energy of the first form may comprise sound waves, whereas the energy of the second form may comprise electric energy. Optionally, 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. Preferably, 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.

Transforming Wireless Energy

[0090] In accordance with a particular embodiment, an implantable energy-transforming device is provided 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. For example, the wireless energy of the first form may comprise sound waves, whereas the energy of the second form may comprise electric energy. Optionally, 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. Preferably, 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.

[0091] The energy-transforming device may function different from or similar to the energy-transmission device. Advantageously, 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. More specifically, 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

SUBSTITUTE SHEEKRULE 26) transmitted by the energy-transmission device, whereby the energy of the second form comprises electric energy.

[0092] 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. For example, the method may comprise shifting the polarity of the energy of the second form to reverse the motor.

[0093] 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. Preferably, the compression/stimulation unit is directly operated with the energy of the second form in a non-magnetic, non-thermal or non-mechanical manner.

[0094] Normally, 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. [0095] 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.

[0096] The internal source of energy may store the energy of the second form. In this case, 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. Where 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. Alternatively, 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. In this alternative, the internal source of energy may be a battery and the switch described above may or may not be provided.

[0097] Suitably, the method may comprise implanting a stabilizer for stabilizing the energy of the second form. Where the energy of the second form comprises electric energy the stabilizer suitably comprises at least one capacitor.

[0098] 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.

Control of Compression/stimulation Unit

[0099] In most applications there will be daily adjustments of the compression device. Therefore, in an embodiment, 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.

[00100] The method suitably comprises operating the control device by the patient. In a simple form 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. It is preferable, however, that 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 wail portion. The wireless remote control is suitably designed for application on the patient's body like a wristwatch.

[00101] 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. Also the carrier signal may comprise digital, analogue or a combination of digital and analogue signals.

[00102] 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.

[00103] Alternatively, the control signal may comprise an electric or magnetic field, or a combined electric and magnetic field.

Operation of Compression/stimulation Unit

[00104] 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. Although the compression/stimulation unit in embodiments described above suitably is designed as a single piece, which is most practical for implantation, it should be noted that as an alternative the compression device and stimulation device of the compression/stimulation unit could be designed as separate pieces.

Laparoscopic method [00105] The present invention also provides a laparoscopic method.

Accordingly, there is provided a method for controlling a flow blood in a lumen formed by a tissue wall of a patient's heart. The method comprises the steps of: inserting a needle like tube into the thorax of the patients body, filling the thorax with gas thereby expanding the thoraxial cavity, placing at least two Iaparoscopical trocars in the patient's body, inserting a camera through one of the trocars into the thorax, 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.

Alternativel the method for controlling a flow of blood in a lumen formed by a tissue wall of a patient's heart, the method comprising the steps of: cutting the skin opening the thorax inserting a dissecting tool 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. [00106] The two methods above 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. For both methods above is further comprising all methods below:

[00107] 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.

[00108] 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.

[00109] Alternatively, 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. Alternatively, 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.

Feed back related to the Wireless Energy

The following embodiments are related to feed back information related to an energy balance either comparing; a) the amount of energy received by the internal energy source compared to the energy used by the constriction device and/or stimulation device, or b) The amount of energy received by the internal energy source and the amount of energy transmitted by the external eenrgy source.

[00110] Several alternatives of the method of the present invention are disclosed below and may except being correlated directly to the constriction device and/or stimulation device also be included in the operating method. These methods are valid for use both with the stimulation device and constriction device separate or in combination.

[00111] A method for controlling the transmission of wireless energy comprising an internal energy source, wherein said wireless energy is transmitted from an external energy source located outside the patient and is received by the internal energy source located inside the patient, the internal energy source being connected to the constriction device and/or stimulation device for directly or indirectly supplying received energy thereto, the method comprising the steps of:

- determining an energy balance between the energy received by the internal energy source and the energy used for the constriction device and/or stimulation device, and

- controlling the transmission of wireless energy from the external energy source, based on the determined energy balance.

[00112] A method, wherein the amount of transmitted wireless energy is decreased if the detected energy balance change implies that the energy balance is increasing, or vice versa. [00113] A method, wherein the wireless energy is transmitted inductively from a primary coil in the external energy source to a secondary coil in the internal energy receiver.

[00114] A method, wherein a change in said energy balance is detected, and the transmission of wireless energy is controlled based on said detected energy balance change.

[00115] A method, wherein a difference is detected between energy received by said internal energy receiver and energy used for a medical device, and the transmission of wireless energy is controlled based on said detected energy difference.

[00116] A method, wherein the decrease/increase of energy transmission corresponds to a detected change rate.

[00117] A method, wherein the amount of transmitted wireless energy is decreased if the detected energy difference implies that the received energy is greater than the used energy, or vice versa.

[00118] A method, wherein the decrease/increase of energy transmission corresponds to the magnitude of said detected energy difference.

[00119] A method, wherein the energy used for the constriction device and/or stimulation device is stored in at least one energy storage device of the device.

[00120] A method, wherein substantially all the energy used for the constriction device and/or stimulation device device i is consumed to operate the device.

[00121] A method, wherein the energy is consumed after being stabilised in at least one energy stabilising unit of the device. [00122] A method, wherein the energy used for the constriction device and/or stimulation device device is stored in at least one energy storage device of the device.

[00123] A method, wherein substantially all the energy used for the constriction device and/or stimulation device i is consumed to operate the device.

[00124] A method, wherein the energy is consumed after being stabilised in at least one energy stabilising unit of the device.

[00125] A method of controlling transmission of wireless energy supplied to the at least one of the stimulation and constriction devices, comprising an internal energy source located inside the patient, connected to the constriction device and/or stimulation device for directly or indirectly supplying received energy thereto, the method comprising the steps of: [00126] determining an energy balance between the energy sent by the external energy source and the energy received by the internal energy source

, and

[00127] controlling the transmission of wireless energy from the external energy source, based on the determined energy balance.

[00128] A method, wherein the wireless energy is transmitted inductively from a primary coil in the external energy source to a secondary coil in the internal energy receiver.

[00129] A method, wherein a change in said energy balance is detected, and the transmission of wireless energy is controlled based on said detected energy balance change.

[00130] A method, wherein a difference is detected between the energy sent by the external energy source and the energy received by said internal energy receiver , and the transmission of wireless energy is controlled based on said detected energy difference.

[00131] A method, wherein the amount of transmitted wireless energy is decreased if the detected energy balance change implies that the energy balance is increasing, or vice versa.

[00132] A method, wherein the decrease/increase of energy transmission corresponds to a detected change rate.

[00133] A method, wherein the amount of transmitted wireless energy is decreased if the detected energy difference implies that the received energy is greater than the used energy, or vice versa.

[00134] A method, wherein the decrease/increase of energy transmission corresponds to the magnitude of said detected energy difference.

[00135] A method of controlling transmission of wireless energy, wherein said wireless energy being transmitted by means of a primary coil in the external energy source and received inductively by means of a secondary coil in an internal energy source, the internal energy source being connected to the medical device for directly or indirectly supplying received energy thereto, wherein feedback control information (S) is transferred from the secondary coil to the primary coil by switching the secondary coil on and off to induce a detectable impedance load variation in the primary coil encoding the feedback control information, wherein the feedback control information relates to the energy received by the internal energy source and is used for controlling the transmission of wireless energy from the external energy source.

[00136] 285 The apparatus according to claim 284, wherein the external energy source further comprises an electronic circuit for comparing the feedback information with the amount of energy transmitted by the external energy source. [00137] The method, wherein the electronic circuit comprises an analyzer analyzing the amount of energy being transmitted and receiving the feedback information related to the amount of energy received in the receiver, and determining the energy balance by comparing the amount of transmitted energy and the feedback information related to the amount of received energy.

[00138] The method, wherein the external energy source is adapted to use said feedback information adjusting the level of said transmitted energy.

[00139] A method of controlling transmission of wireless energy, wherein said wireless energy being transmitted by means of a primary coil in an external energy source and received inductively by means of a secondary coil in an internal energy source, the internal energy receiver being connected to the medical device for directly or indirectly supplying received energy thereto, wherein feedback control information (S) is transferred from the secondary coil to the primary coil by switching the secondary coil on and off to induce a detectable impedance load variation in the primary coil encoding the feedback control information, where the feedback control information relates to said energy balance.

BRIEF DESCRIPTION OF THE DRAWINGS

[00140] FIGURES 1A, 1 B, 1C, 1 D and 1 E schematically illustrate different states of operation of a general embodiment of an apparatus according to the present invention.

[00141] FIGURES 1 F₁ 1 G and 1 H illustrate different states of operation of a modification of the general embodiment.

[00142] FIGURES 11, 1 K and 1 L illustrate an alternative mode of operation of the modification of the general embodiment.

[00143] FIGURE 2 is a longitudinal cross-section of a preferred embodiment of the apparatus including a compression device and an electric stimulation device.

[00144] FIGURE 3 is a cross-section along line Ill-Ill in FIGURE 2.

[00145] FIGURE 4 is the same cross-section shown in FIGURE 3, but with the apparatus in a different state of operation.

[00146] FIGURES 5 shows the apparatus when placed on a heart.

[00147] 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.

[00148] FIGURES 7A₁ 7B₁ 7C and 7D show different embodiments of the apparatus when placed on a heart.

[00149] 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.

[00150] FIGURE 8B is pulse/time diagram showing a modification of the electric stimulation shown in FIGURE 8A₁ in which pulses of mixed frequencies and/or amplitudes are employed.

[00151] 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.

[00152] FIGURES 10A and 10B show the pulse/time diagrams of

FIGURES 9A and 9B with modified pulse trains. [00153] 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. [00154] FIGURE 11 B is the same embodiment of FIGURE 11A with the thermal stimulation device activated.

[00155] FIGURE 12A is a schematic view of hydraulic operation means suited for operating the compression device of the embodiments of FIGURES

2-11.

[00156] FIGURE 12B shows the embodiment of FIGURE 12A with the compression device compressing/constricting a tissue wall of a patient's heart.

[00157] FIGURE 13A is a schematic view of mechanical operation means suited for operating the compression device of the embodiments of

FIGURES 2-11.

[00158] FIGURE 13B shows the embodiment of FIGURE 13A with the compression device compressing a tissue wall of a patient's heart.

[00159] FIGURE 13C shows a modification of the embodiment of

FIGURE 13B.

[00160] FIGURE 14 is a cross-sectional view of a reservoir having a variable volume controlled by a remote control motor.

[00161] FIGURES 15A and 15B are perspective views of a reverse servo.

[00162] 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.

[00163] 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.

[00164] FIGURE 29 illustrates an energy-transforming device in the form of an electrical junction element for use in the apparatus of the present invention. [00165] FIGURE 30 is a block diagram illustrating control components of an embodiment.

[00166] FIGURE 31 is a schematic view of exemplary circuitry of an embodiment in which wireless energy is transformed into a current.

[00167] FIGURE 32 is a schematic block diagram illustrating an arrangement for supplying an accurate amount of wireless energy used for the operation of the constriction/stimulation unit as described above.

[00168] FIGURE 33 schematically shows an embodiment of the invention, in which the apparatus is operated with wire bound energy.

[00169] FIGURE 34 is a more detailed block diagram of an arrangement for controlling the transmission of wireless energy used for the operation of the constriction/stimulation unit as described above.

[00170] FIGURE 35 is a circuit for the arrangement, according to a possible implementation example.

DETAILED DESCRIPTION

[00171] Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures. [00172] FIGURES 1A, 1B and 1 C 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. [00173] 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 1C shows the apparatus in a stimulation state, in which the control device CD controls the stimulation

8>ISΪ:Ϊ device to stimulate different areas of the compressed wall portion, so that the wall portion of the heart BO contracts (thickens).

[00174] 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. It should be noted that 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. Also, groups of different areas of the compressed wall portion may be successively stimulated. [00175] FIGURES 1 F, 1G 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.

[00176] 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.

[00177] 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. By 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. [00178] FIGURES 11, 1 K and 1 L illustrate an alternative mode of operation of the modification of the general embodiment. Thus, FIGURE 11 shows how the element CSDE1 in a first state of operation is activated to both compress and stimulate the heart BO₁ 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 1 L 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. By 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 stimulated while maintaining the compression on the heart. It is also possible to activate the stimulation of the elements CSDE1-CSDE3 successively along the heart BO to move blood.

[00179] 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. Thus, in this embodiment the compression and stimulation devices form a compression/stimulation unit, in which the compression and stimulation devices are integrated in a single piece.

[00180] The compression and stimulation devices may also be separate from each other. In this case, a structure may be provided for holding the electrical elements 7 in a fixed orientation relative to one another. Alternatively, the electrical elements 7 may include electrodes that are separately attached to the wall portion of the patient's heart. [00181] When the apparatus is in its stimulation state, it is important to stimulate the different areas of the wall portion 8 in a manner so that they essentially maintain their natural physical properties over time to prevent the areas from being injured. Consequently, 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. Furthermore, the 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. To maintain over time the effect of stimulation, the 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. To achieve the desired reaction of the tissue wall during the stimulation thereof, the control device may control the stimulation device to, preferably cyclically, vary the intensity of the stimulation of the wall portion 8. [00182] In the embodiment of FIGURES 2 - 4, 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. Thus, the two paths of electrical elements 7 extend on mutual sides of the patient's heart. The control device 4 controls the stimulation device 3 to successively energize the groups of electrical elements 7 in the series of groups in a direction opposite to or, alternatively, in the same direction as that of the flow in the vascularsystem of the patient's. Of course, the number of electrical elements 7 of each path of electrical elements 7 can be greater or smaller than four, and several parallel rows electrical elements 7 can form each path of electrical elements 7. [00183] 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. According to an embodiment 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.

[00184] 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-10c, wherein the electrical elements 11a - 11c of each group of electrical elements form a path of three electrical elements 11a, 11b and 11c 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-10c, respectively. Thus, the path of three electrical elements 11a-11c extends around the patient's heart. Of course, 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.

[00185] 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.

[00186] 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. Thus, 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. For neural stimulation, a pulse current of about 5mA and a pulse duration of about 300μs are suitable, whereas a pulse current of about 2OmA and a pulse duration of about 30μs are suitable for muscular stimulation. The pulse repetition frequency suitably is about 10Hz. For example, as illustrated in the Pulse/time diagram P/t of FIGURE 8A, 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.

[00187] FIGURE 8B is a pulse/time diagram showing a modification of the electric stimulation shown in FIGURE 8A. Thus, 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. As a result, 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.

[00188] Preferably, 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. [00189] 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. [00190] 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. In this case, the pulse trains are shifted relative to each other, so that they do not overlap each other. Thus, 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.

[00191] FIGURES 11 A and 11 B 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 21 b 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 21b. 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, 21b 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, 21b to heat the wall of the blood vessel 19, so that the wall expands.

[00192] 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.) Thus, 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.

[00193] Alternatively, the embodiment of 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. [00194] 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. [00195] In all of the above embodiments according to FIGURES 12A through 13B, 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.

[00196] 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.

[00197] Where applicable, 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. For example, the fluid supply device of FIGURE 14 may be substituted for a reservoir.

[00198] 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.

[00199] Referring to 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. [00200] 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. Alternatively, 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.

[00201] 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. Thus, in FIGURE 17 all parts placed to the right of the patient's skin 109 are implanted and all parts placed to the left of the skin 109 are 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.

[00202] The apparatus of FIGURE 17 may also include an implanted rechargeable battery for energizing energy consuming implanted components of the apparatus. In this case, 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. [00203] 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. When the polarity of the current is shifted by the energy-transforming-device 111A the switch 114 reverses the function performed by the compression device of the compression/stimulation unit 110.

[00204] 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. [00205] 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. In this case 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.

[00206] 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 111B. The motor of the motor/pump unit 120 is an electric motor. In response to a control signal from the wireless remote control of the external energy-transmission device 113, 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 111 B 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.

[00207] FIGURE 21 shows an embodiment including the energy- transforming device 111A 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 111A to store electric energy in the accumulator 123, which supplies energy to the compression/stimulation unit 110. 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.

[00208] In accordance with one alternative, the capacitor 124 in the embodiment of FIGURE 21 may be omitted. In accordance with another alternative, the accumulator 123 in this embodiment may be omitted. [00209] FIGURE 22 shows an embodiment including the energy- transforming device 111A, the compression/stimulation unit 110. A battery

125 for supplying energy for the operation of the compression/stimulation unit 110 and an electric switch 126 for switching the operation of the compression/stimulation unit 110 are also implanted in the patient. The switch

126 is operated by the energy supplied by the energy-transforming device 111 A 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.

[00210] FIGURE 23 shows an embodiment identical to that of FIGURE 22, except that a control unit 122 also is implanted in the patient. A separate external wireless remote control 111B controls the control unit 122. In this case, the switch 126 is operated by the energy supplied by the energy- transforming device 111A to switch from an off mode, in which the wireless remote control 111 B is prevented from controlling the control unit 122 and the battery 125 is not in use, to a standby mode, in which the remote control 111B is permitted to control the control unit 122 to release electric energy from the battery 125 for the operation of the compression/stimulation unit 110. [00211] FIGURE 24 shows an embodiment identical to that of FIGURE

23, except that the accumulator 123 is substituted for the battery 125 and the implanted components are interconnected differently. In this case, the accumulator 123 stores energy from the energy-transforming device 111A. In response to a control signal from the wireless remote control 111 B, 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.

[00212] FIGURE 25 shows an embodiment identical to that of FIGURE

24, except that the battery 125 also is implanted in the patient, and the implanted components are interconnected differently. In response to a control signal from the wireless remote control 111B, 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.

[00213] Alternatively, 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 111 B is permitted to control the battery 125 to supply electric energy for the operation of the compression/stimulation unit 110.

[00214] 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 111B 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.

[00215] FIGURE 27 shows an embodiment identical to that of FIGURE 25, except that the implanted components are interconnected differently. Thus, in this case, 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. When the switch 126 is in its 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.

[00216] 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. [00217] Optionally, the accumulator 123 shown in FIGURE 21 may be provided in the embodiment of FIGURE 28, wherein the implanted 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 111 B, the control unit 122 controls the accumulator

123 to supply energy for the operation of the compression/stimulation unit 110.

[00218] Those skilled in the art will realise that the above various embodiments according to FIGURES 17-28 could be combined in many different ways. For example, 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. Alternatively, however, 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". [00219] Alternatively, a permanent or rechargeable battery may be substituted for the energy-transforming devices 111A of the embodiments shown in FIGURES 17-28.

[00220] 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.

[00221] I = IO (exp(qV/kT)-1 ) Where I is the external current flow, IO is the reverse saturation current, q is the fundamental electronic charge of 1.602 x 10-19 coulombs, V is the applied voltage, k is the Boltzmann constant, and T is the absolute temperature.

[00222] Under large negative applied voltage (reverse bias), the exponential term becomes negligible compared to 1.0, and I is approximately -I0. IO is strongly dependent on the temperature of the junction and hence on the intrinsic-carrier concentration. IO is larger for materials with smaller bandgaps than for those with larger bandgaps. The rectifier action of the diode, that is, its restriction of current flow to only one direction, is in this particular embodiment the key to the operation of the p-n junction element 128.

[00223] 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. For use with wirelessly transmitted energy in terms of light waves, glass could be a suitable material. Various materials may be used in the semiconductor layers, such as, but not limited to, cadmium teliuride, 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. [00224] 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. Alternatively, the negative and positive semiconductor layers may change polarity following the transmitted waves, thereby generating the alternating current.

[00225] 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 μA, 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. The volume of the element 128 should be kept less than 2000 cm³. [00226] FIGURE 30 shows basic parts of a remote control of the apparatus for controlling the compression/stimulation unit 110. In this case, 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. In FIGURE 30, 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. [00227] An external signal-transmission device 133 is to be positioned close to a signal-receiving device 134 implanted close to the skin 132. As an alternative, 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.

[00228] 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.

[00229] The commands are sent continuously during a rather long time period (e.g., about 30 seconds or more). When a new compression or release step is desired, 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.

[00230] Through a line 136, 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. [00231] 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.

[00232] FIGURE 31 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.

[00233] 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. Thus, the coil 150 makes it possible to charge the capacitor 148 and to transmit digital information using amplitude modulation. [00234] 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. [00235] 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.

[00236] Alternatively, 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. In this case 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.

[00237] While a method has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

[00228] FIGURE 32 schematically illustrates an arrangement capable of sending information from inside the patient's body to the outside thereof to give information related to at least one functional parameter of the apparatus, and/or related to a physical parameter of the patient, in order to supply an accurate amount of energy to an implanted internal energy receiver 302 connected to energy consuming components of an implanted constriction/stimulation unit 301 of the apparatus. Such an energy receiver 302 may include a source of energy and/or an energy-transforming device. Briefly described, wireless energy is transmitted from an external source of energy 304a located outside the patient and is received by the internal energy receiver 302 located inside the patient. The internal energy receiver is adapted to directly or indirectly supply received energy to the energy consuming components of the constriction/stimulation unit 301 via a switch 326. An energy balance is determined between the energy received by the internal energy receiver 302 and the energy used for the constriction/stimulation unit 301 , and the transmission of wireless energy is then controlled based on the determined energy balance. The energy balance thus provides an accurate indication of the correct amount of energy needed, which is sufficient to operate the constriction/stimulation unit 301 properly, but without causing undue temperature rise.

[00229] In FIGURE 32 the patient's skin is indicated by a vertical line 305. Here, the energy receiver comprises an energy-transforming device 302 located inside the patient, preferably just beneath the patient's skin 305. Generally speaking, the implanted energy-transforming device 302 may be placed in the abdomen, thorax, muscle fascia (e.g. in the abdominal wall), subcutaneously, or at any other suitable location. The implanted energy- transforming device 302 is adapted to receive wireless energy E transmitted from the external source of energy 304a provided in an external energy- transmission device 304 located outside the patient's skin 305 in the vicinity of the implanted energy-transforming device 302.

[00230] As is well known in the art, the wireless energy E may generally be transferred by means of any suitable Transcutaneous Energy Transfer (TET) device, such as a device including a primary coil arranged in the external source of energy 304a and an adjacent secondary coil arranged in the implanted energy-transforming device 302. When an electric current is fed through the primary coil, energy in the form of a voltage is induced in the secondary coil which can be used to power the implanted energy consuming components, e.g. after storing the incoming energy in an implanted source of energy, such as a rechargeable battery or a capacitor. However, the present invention is generally not limited to any particular energy transfer technique, TET devices or energy sources, and any kind of wireless energy may be used. [00231] The amount of energy received by the implanted energy receiver may be compared with the energy used by the implanted components of the apparatus. The term "energy used" is then understood to include also energy stored by implanted components of the apparatus. A control device includes an external control unit 304b that controls the external source of energy 304a based on the determined energy balance to regulate the amount of transferred energy. In order to transfer the correct amount of energy, the energy balance and the required amount of energy is determined by means of a determination device including an implanted internal control unit 315 connected between the switch 326 and the constriction/stimulation unit 301. The internal control unit 315 may thus be arranged to receive various measurements obtained by suitable sensors or the like, not shown, measuring certain characteristics of the constriction/stimulation unit 301 , somehow reflecting the required amount of energy needed for proper operation of the constriction/stimulation unit 301. Moreover, the current condition of the patient may also be detected by means of suitable measuring devices or sensors, in order to provide parameters reflecting the patient's condition. Hence, such characteristics and/or parameters may be related to the current state of the constriction/stimulation unit 301 , such as power consumption, operational mode and temperature, as well as the patient's condition reflected by parametyers such as: body temperature, blood pressure, heartbeats and breathing. Other kinds of physical parameters of the patient and functional parameters of the device are described elsewhere. [00232] Furthermore, a source of energy in the form of an accumulator 316 may optionally be connected to the implanted energy-transforming device 302 via the control unit 315 for accumulating received energy for later use by the constriction/stimulation unit 301. Alternatively or additionally, characteristics of such an accumulator, also reflecting the required amount of energy, may be measured as well. The accumulator may be replaced by a rechargeable battery, and the measured characteristics may be related to the current state of the battery, any electrical parameter such as energy consumption voltage, temperature, etc. In order to provide sufficient voltage and current to the constriction/stimulation unit 301 , and also to avoid excessive heating, it is clearly understood that the battery should be charged optimally by receiving a correct amount of energy from the implanted energy- transforming device 302, i.e. not too little or too much. The accumulator may also be a capacitor with corresponding characteristics. [00233] For example, battery characteristics may be measured on a regular basis to determine the current state of the battery, which then may be stored as state information in a suitable storage means in the internal control unit 315. Thus, whenever new measurements are made, the stored battery state information can be updated accordingly. In this way, the state of the battery can be "calibrated" by transferring a correct amount of energy, so as to maintain the battery in an optimal condition.

[00234] Thus, the internal control unit 315 of the determination device is adapted to determine the energy balance and/or the currently required amount of energy, (either energy per time unit or accumulated energy) based on measurements made by the above-mentioned sensors or measuring devices of the apparatus, or the patient, or an implanted source of energy if used, or any combination thereof. The internal control unit 315 is further connected to an internal signal transmitter 327, arranged to transmit a control signal reflecting the determined required amount of energy, to an external signal receiver 304c connected to the external control unit 304b. The amount of energy transmitted from the external source of energy 304a may then be regulated in response to the received control signal.

[00235] Alternatively, the determination device may include the external control unit 304b. In this alternative, sensor measurements can be transmitted directly to the external control unit 304b wherein the energy balance and/or the currently required amount of energy can be determined by the external control unit 304b, thus integrating the above-described function of the internal control unit 315 in the external control unit 304b. In that case, the internal control unit 315 can be omitted and the sensor measurements are supplied directly to the internal signal transmitter 327 which sends the measurements over to the external signal receiver 304c and the external control unit 304b. The energy balance and the currently required amount of energy can then be determined by the external control unit 304b based on those sensor measurements. [00236] Hence, the present solution according to the arrangement of FIGURE 32 employs the feed back of information indicating the required energy, which is more efficient than previous solutions because it is based on the actual use of energy that is compared to the received energy, e.g. with respect to the amount of energy, the energy difference, or the energy receiving rate as compared to the energy rate used by implanted energy consuming components. The apparatus may use the received energy either for consuming or for storing the energy in an implanted source of energy or the like. The different parameters discussed above would thus be used if relevant and needed and then as a tool for determining the actual energy balance. However, such parameters may also be needed per se for any actions taken internally to specifically operate the apparatus. [00237] The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfer means, such as radio, IR (Infrared) or ultrasonic signals. Alternatively, the internal signal transmitter 327 and the external signal receiver 304c may be integrated in the implanted energy-transforming device 302 and the external source of energy 304a, respectively, so as to convey control signals in a reverse direction relative to the energy transfer, basically using the same transmission technique. The control signals may be modulated with respect to frequency, phase or amplitude. [00238] Thus, the feedback information may be transferred either by a separate communication system including receivers and transmitters or may be integrated in the energy system. Such an integrated information feedback and energy system comprises an implantable internal energy receiver for receiving wireless energy, the energy receiver having an internal first coil and a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy, the energy transmitter having an external second coil and a second electronic circuit connected to the second coil. The external second coil of the energy transmitter transmits wireless energy which is received by the first coil of the energy receiver. This system further comprises a power switch for switching the connection of the internal first coil to the first electronic circuit on and off, such that feedback information related to the charging of the first coil is received by the external energy transmitter in the form of an impedance variation in the load of the external second coil, when the power switch switches the connection of the internal first coil to the first electronic circuit on and off. In implementing this system, the switch 326 is either separate and controlled by the internal control unit 315, or integrated in the internal control unit 315. It should be understood that the switch 326 should be interpreted in its broadest embodiment. This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or any other electronic component or circuit that may switch the power on and off. [00239] To conclude, the energy supply arrangement illustrated in FIGURE 32 may operate basically in the following manner. The energy balance is first determined by the internal control unit 315 of the determination device. A control signal reflecting the required amount of energy is also created by the internal control unit 315, and the control signal is transmitted from the internal signal transmitter 327 to the external signal receiver 304c. Alternatively, the energy balance can be determined by the external control unit 304b instead depending on the implementation, as mentioned above. In that case, the control signal may carry measurement results from various sensors. The amount of energy emitted from the external source of energy 304a can then be regulated by the external control unit 304b, based on the determined energy balance, e.g. in response to the received control signal. This process may be repeated intermittently at certain intervals during ongoing energy transfer, or may be executed on a more or less continuous basis during the energy transfer.

[00240] The amount of transferred energy can generally be regulated by adjusting various transmission parameters in the external source of energy 304a, such as voltage, current, amplitude, wave frequency and pulse characteristics.This system may also be used to obtain information about the coupling factors between the coils in a TET system even to calibrate the system both to find an optimal place for the external coil in relation to the internal coil and to optimize energy transfer. Simply comparing in this case the amount of energy transferred with the amount of energy received. For example if the external coil is moved the coupling factor may vary and correctly displayed movements could cause the external coil to find the optimal place for energy transfer. Preferably, the external coil is adapted to calibrate the amount of transferred energy to achieve the feedback information in the determination device, before the coupling factor is maximized.

[00241] This coupling factor information may also be used as a feedback during energy transfer. In such a case, the energy system of the present invention comprises an implantable internal energy receiver for receiving wireless energy, the energy receiver having an internal first coil and a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy, the energy transmitter having an external second coil and a second electronic circuit connected to the second coil. The external second coil of the energy transmitter transmits wireless energy which is received by the first coil of the energy receiver. This system further comprises a feedback device for communicating out the amount of energy received in the first coil as a feedback information, and wherein the second electronic circuit includes a determination device for receiving the feedback information and for comparing the amount of transferred energy by the second coil with the feedback information related to the amount of energy received in the first coil to obtain the coupling factor between the first and second coils. The energy transmitter may regulate the transmitted energy in response to the obtained coupling factor.

[00242] With reference to FIGURE 33, although wireless transfer of energy for operating the apparatus has been described above to enable noninvasive operation, it will be appreciated that the apparatus can be operated with wire bound energy as well. Such an example is shown in FIGURE 57, wherein an external switch 326 is interconnected between the external source of energy 304a and an operation device, such as an electric motor 307 operating the constriction/stimulation unit 301. An external control unit 304b controls the operation of the external switch 326 to effect proper operation of the constriction/stimulation unit 301.

[00243] FIGURE 34 illustrates different embodiments for how received energy can be supplied to and used by the constriction/stimulation unit 301. Similar to the example of FIGURE 32, an internal energy receiver 302 receives wireless energy E from an external source of energy 304a which is controlled by a transmission control unit 304b. The internal energy receiver 302 may comprise a constant voltage circuit, indicated as a dashed box "constant V" in FIGURE 34, for supplying energy at constant voltage to the constriction/stimulation unit 301. The internal energy receiver 302 may further comprise a constant current circuit, indicated as a dashed box "constant C" in the figure, for supplying energy at constant current to the constriction/stimulation unit 301.

[00244] The constriction/stimulation unit 301 comprises an energy consuming part 301a, which may be a motor, pump, restriction device, or any other medical appliance that requires energy for its electrical operation. The constriction/stimulation unit 301 may further comprise an energy storage device 301 b for storing energy supplied from the internal energy receiver 302. Thus, the supplied energy may be directly consumed by the energy consuming part 301a, or stored by the energy storage device 301 b, or the supplied energy may be partly consumed and partly stored. The constriction/stimulation unit 301 may further comprise an energy stabilizing unit 301c for stabilizing the energy supplied from the internal energy receiver 302. Thus, the energy may be supplied in a fluctuating manner such that it may be necessary to stabilize the energy before consumed or stored. [00245] The energy supplied from the internal energy receiver 302 may further be accumulated and/or stabilized by a separate energy stabilizing unit 328 located outside the constriction/stimulation unit 301 , before being consumed and/or stored by the constriction/stimulation unit 301. Alternatively, the energy stabilizing unit 328 may be integrated in the internal energy receiver 302. In either case, the energy stabilizing unit 328 may comprise a constant voltage circuit and/or a constant current circuit. [00246] It should be noted that FIGURE 32 and FIGURE 58 illustrate some possible but non-limiting implementation options regarding how the various shown functional components and elements can be arranged and connected to each other. However, the skilled person will readily appreciate that many variations and modifications can be made within the scope of the present invention.

[00247] FIGURE 35 schematically shows an energy balance measuring circuit of one of the proposed designs of the apparatus for controlling transmission of wireless energy, or energy balance. The circuit has an output signal centered on 2.5V and proportionally related to the energy imbalance. The derivative of this signal shows if the value goes up and down and how fast such a change takes place. If the amount of received energy is lower than the energy used by implanted components of the apparatus, more energy is transferred and thus charged into the source of energy. The output signal from the circuit is typically fed to an A/D converter and converted into a digital format. The digital information can then be sent to the external energy- transmission device allowing it to adjust the level of the transmitted energy. Another possibility is to have a completely analog system that uses comparators comparing the energy balance level with certain maximum and minimum thresholds sending information to external energy-transmission device if the balance drifts out of the max/min window. [00248] The schematic FIGURE 35 shows a circuit implementation for a system that transfers energy to the implanted energy components of the apparatus from outside of the patient's body using inductive energy transfer. An inductive energy transfer system typically uses an external transmitting coil and an internal receiving coil. The receiving coil, L1 , is included in the schematic FIGURE 59; the transmitting parts of the system are excluded. [00249] The implementation of the general concept of energy balance and the way the information is transmitted to the external energy transmitter can of course be implemented in numerous different ways. The above described method of evaluating and transmitting the information should only be regarded as examples of how to implement the control system.

CIRCUIT DETAILS

[00250] In FIGURE 35 the symbols Y1 , Y2, Y3 and so on symbolize test points within the circuit. The components in the diagram and their respective values are values that work in this particular implementation which of course is only one of an infinite number of possible design solutions.

[00251] Energy to power the circuit is received by the energy receiving coil L1. Energy to implanted components is transmitted in this particular case at a frequency of 25 kHz. The energy balance output signal is present at test point Y1. [00252] Thθ embodiments described in connection with FIGURES 32, 34 and 35 identify a general method of the present invention for controlling transmission of wireless energy to implanted energy consuming components of the apparatus. Such a method will be defined in general terms in the following.

[00253] A method is thus provided for controlling transmission of wireless energy supplied to implanted energy consuming components of an apparatus as described above. The wireless energy E is transmitted from an external source of energy located outside the patient and is received by an internal energy receiver located inside the patient, the internal energy receiver being connected to the implanted energy consuming components of the apparatus for directly or indirectly supplying received energy thereto. An energy balance is determined between the energy received by the internal energy receiver and the energy used for the operation of the implanted parts of the apparatus. The transmission of wireless energy E from the external source of energy is then controlled based on the determined energy balance. [00254] The wireless energy may be transmitted inductively from a primary coil in the external source of energy to a secondary coil in the internal energy receiver. A change in the energy balance may be detected to control the transmission of wireless energy based on the detected energy balance change. A difference may also be detected between energy received by the internal energy receiver and energy used for the operation of the implanted parts of the apparatus, to control the transmission of wireless energy based on the detected energy difference.

[00255] When controlling the energy transmission, the amount of transmitted wireless energy may be decreased if the detected energy balance change implies that the energy balance is increasing, or vice versa. The decrease/increase of energy transmission may further correspond to a detected change rate.

[00256] The amount of transmitted wireless energy may further be decreased if the detected energy difference implies that the received energy is greater than the used energy, or vice versa. The decrease/increase of energy transmission may then correspond to the magnitude of the detected energy difference. .1 ~ ~ \L^~ iUUW

[00257] As mentioned above, the energy used for the operation of the implanted parts of the apparatus be consumed to operate the implanted parts of the apparatus and/or stored in at least one implanted energy storage device of the apparatus.

[00258] When electrical and/or physical parameters of the implanted parts of the apparatus and/or physical parameters of the patient are determined, the energy may be transmitted for consumption and storage according to a transmission rate per time unit which is determined based on said parameters. The total amount of transmitted energy may also be determined based on said parameters.

[00259] When a difference is detected between the total amount of energy received by the internal energy receiver and the total amount of consumed and/or stored energy, and the detected difference is related to the integral over time of at least one measured electrical parameter related to said energy balance, the integral may be determined for a monitored voltage and/or current related to the energy balance.

[00260] When the derivative is determined over time of a measured electrical parameter related to the amount of consumed and/or stored energy, the derivative may be determined for a monitored voltage and/or current related to the energy balance.

[00261] The transmission of wireless energy from the external source of energy may be controlled by applying to the external source of energy electrical pulses from a first electric circuit to transmit the wireless energy, the electrical pulses having leading and trailing edges, varying the lengths of first time intervals between successive leading and trailing edges of the electrical pulses and/or the lengths of second time intervals between successive trailing and leading edges of the electrical pulses, and transmitting wireless energy, the transmitted energy generated from the electrical pulses having a varied power, the varying of the power depending on the lengths of the first and/or second time intervals.

[00262] In that case, the frequency of the electrical pulses may be substantially constant when varying the first and/or second time intervals. When applying electrical pulses, the electrical pulses may remain unchanged, except for varying the first and/or second time intervals. The amplitude of the electrical pulses may be substantially constant when varying the first and/or second time intervals. Further, the electrical pulses may be varied by only varying the lengths of first time intervals between successive leading and trailing edges of the electrical pulses.

[00263] A train of two or more electrical pulses may be supplied in a row, wherein when applying the train of pulses, the train having a first electrical pulse at the start of the pulse train and having a second electrical pulse at the end of the pulse train, two or more pulse trains may be supplied in a row, wherein the lengths of the second time intervals between successive trailing edge of the second electrical pulse in a first pulse train and leading edge of the first electrical pulse of a second pulse train are varied [00264] When applying the electrical pulses, the electrical pulses may have a substantially constant current and a substantially constant voltage. The electrical pulses may also have a substantially constant current and a substantially constant voltage. Further, the electrical pulses may also have a substantially constant frequency. The electrical pulses within a pulse train may likewise have a substantially constant frequency.

[00265] The circuit formed by the first electric circuit and the external source of energy may have a first characteristic time period or first time constant, and when effectively varying the transmitted energy, such frequency time period may be in the range of the first characteristic time period or time constant or shorter.

Claims

WHAT IS CLAIMED IS:

1. A method for controlling a flow of blood in a lumen formed by a tissue wall of a patient's heart, the method comprising: a) gently constricting at least one portion of the tissue wall to influence the flow in the lumen, and b) stimulating the constrictad wall portion to cause contraction of the wall portion to further influence the flow in the lumen.

2. The method according to claim 1 , wherein said constricting of said wall portion is compressing of said wall portion to assist the pump function of the heart, and the wall portion is stimulated to at least further assist the pump function of the heart.

3. The method according to claim 2, wherein the wall portion is compressed to a compressed state, in which the blood circulation in the compressed wall portion is substantially unrestricted and the flow in the lumen is affected, and the compressed wall portion is stimulated when it is in the compressed state to at least further affect the blood flow in the lumen.

4. The method according to claim 2, wherein the wall portion is stimulated while the compression of the wall portion is changed.

5. The method according to claim 2, wherein the compression of the wall portion is calibrated by stimulating the wall portion while adjusting the compression of the wall portion until the desired flow in the lumen is obtained.

6. The method according to claim.2, wherein step (b) is not performed while step (a) is performed.

7. The method according to claim 2, wherein steps (a) and (b) are cooperated to move the blood in the lumen.

8. The method according to claim 7, wherein step (a) is performed by compressing the wall portion, and 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.

9. The method according to claim 8, wherein the compressed wall portion is progressively stimulated in the direction of the blood flow in the lumen.

10. The method according to claim 7, wherein step (a) is performed by compressing the wall portion, and step (b) is performed by stimulating the compressed wall portion to close the lumen, further comprising (c) increasing the compression of the wall portion to move the blood in the lumen.

11. The method according to claim 7, wherein step (a) is performed by varyingly compressing the wall portion to vary the flow in the lumen, and step (b) is performed by progressively stimulating the compressed wall portion to cause progressive compression of the wall portion to move the fluid and/or other bodily matter in the lumen.

12. The method according to claim 11 , wherein the compressed wall portion is progressively stimulated in the direction of the blood flow in the lumen.

13. The method according to claim 6, wherein step (a) is performed by varyingly compressing different areas of the wall portion to cause progressive compression of the wall portion in the direction of the blood flow in the lumen.

14. The method according to claim 13, wherein the compressed wall portion is progressively stimulated to cause progressive contraction thereof in harmony with the progressive compression of the wall portion.

15. The method according to claim 13, further comprising providing at least one elongated compression element extending along the wall portion,

HECTHEDSHST(RUUfI) and controlling the elongated compression element to progressively compress the wall portion in the direction of the blood flow in the lumen.

16. The method according to claim 15, wherein the elongated compression element comprises contact surfaces dimensioned to contact a length of the wall portion, further comprising 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.

17. The method according to claim 6, wherein 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, further comprising successively compressing the wall portions of the series of wall portions to move the blood in the lumen in a peristaltic manner.

18. The method according to claim 17, further comprising providing at least one compression element and at least one stimulation element positioned on the compression element, moving the compression element along the heart 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.

19. The method according to claim 18, further comprising cyclically moving the compression element along the wall portions of the series of wall portions.

20. The method according to claim 17, further comprising 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.

RBHlFED SHEET (RULE M)

21. The method according to claim 20, further comprising cyclically moving the compression elements one after the other along the wall portions of the series of wall portions.

22. The method according to claim 21 , further comprising 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.

23. The method according to claim 22, wherein each compression element comprises a roller that rolls on the heart to compress the latter.

24. The method according to claim 6, wherein step (a) is performed by compressing the wall portion at an upstream or downstream end thereof, further comprising (c) compressing the wall portion between the upstream and downstream ends thereof, to move the blood in the wall portion between the upstream and downstream ends thereof in the direction of the blood flow in the lumen.

25. The method according to claim 24, further comprising stimulating the wall portion between the upstream and downstream ends thereof, as step (c) is performed.

26. The method according to claim 24, wherein step (a) is performed by compressing the wall portion at the upstream end thereof, and 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 in the lumen, as step (c) is performed.

25. The method according to claim 24, wherein step (a) is performed by compressing the wall portion at the downstream end thereof, and 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

RBHlFED SHEET 0HJLE 91) and downstream ends thereof is moved in the lumen, as step (c) is performed.

28. The method according to claim 6, wherein step (b) is performed by stimulating the wall portion with electric pulses.

29. The method according to claim 2, further comprising controlling the compression and/or stimulation of the wall portion from outside the patient's body.

30. The method according to claim 29, further comprising controlling by the patient the compression and/or stimulation of the wall portion.

31. The method according to claim 2, further comprising sensing a physical parameter of the patient and controlling the compression and/or stimulation of the wall portion in response to the sensed parameter.

32. The method according to claim 31 , further comprising automatically controlling the compression and/or stimulation of the wall portion in response to the sensed parameter.

33. The method according to claim 2, further comprising 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 stimulation device.

34. The method according to claim 33, further comprising operating the control device from outside the patient's body.

35. The method according to claim 34, further comprising operating the control device by the patient.

36. The method according to claim 35, wherein the control device comprises a manually operable switch for switching on and off the

HtHlFIED SHEET (RULI §1| compression device and/or stimulation device, further comprising subcutaneously implanting the switch in the patient and manually operating the the implanted switch from outside the patient's body.

37. The method according to claim 35, wherein the control device comprises a hand-held wireless remote control that is operated by the patient.

38. The method according to claim 34, further comprising using the control device to wirelessly control the compression device and/or stimulation device.

39. The method according to claim 38, further comprising wirelessly controlling the compression device and/or stimulation device in a nonmagnetic manηer.

40. The method according to claim 2, wherein step (b) is performed by intermittently and individually stimulating different areas of the wall portion so that at least two of the areas are stimulated at different points of time.

41. The method according to claim 40, wherein step (b) is performed by intermittently stimulating each area of the different areas of the wall portion during successive time periods, each time period being short enough to maintain over time satisfactory blood circulation in the area until the laps of the time period.

42. The method according to claim 41 , wherein step (b) is performed by intermittently stimulating the areas of the wall portion so that an area of the wall portion that currently is not stimulated has time to restore substantially normal blood circulation before it is stimulated again.

43. The method according to claim 2, wherein step (b) is performed by stimulating one or more of different areas of the wall portion at a time.

SHEET

44. The method according to claim 43, wherein step (b) is performed by sequentially stimulating the different aeras of the wall portion.

45. The method according to claim 43, wherein step (b) is performed by shifting the stimulation from one area to another over time.

46. The method according to claim 43, wherein step (b) is performed by cyclically propagating the stimulation of the areas along the wall portion in the same or opposite direction of the flow in the patient's lumen.

47. The method according to claim 46, wherein step (b) is performed by propagating the stimulation of the areas in accordance with a determined stimulation pattern.

48. The method according to claim 2, wherein step (b) is performed by stimulating the wall portion with varying stimulation intensity.

49. The method according to claim 48, wherein step (b) is performed by stimulating the wall portion with cyclically varying stimulation intensity.

50. The method according to claim 2, wherein step (b) is performed by stimulating different areas of the wall portion with pulses.

51. The method according to claim 50, wherein step (b) is performed by intermittently and individually stimulating different areas of the wall portion with the pulses.

52. The method according to claim 50, wherein the pulses form pulse trains.

53. The method according to claim 52, wherein the pulse amplitudes of the pulses of the pulse trains are varied.

HtHlFIED SHEET (RUiI i1|

54. The method according to claim 52, wherein the off time periods between the individual pulses of each pulse train are varied.

55. The method according to claim 52, wherein the off time periods between the pulse trains are varied.

56. The method according to claim 52, wherein the width of each pulse of the pulse trains is varied.

57. The method according to claim 52, wherein the frequency of the pulses of the pulse trains is varied.

58. The method according to claim 52, wherein the off time periods between the pulse trains are varied.

59. The method according to claim 52, wherein each off time period between the pulse trains is kept long enough to restore substantially normal blood circulation in each area when the area is not stimulated during the off time periods.

60. The method according to claim 52, wherein the length of each pulse train is varied.

61. The method according to claim 52, wherein the frequency of the pulse trains is varied.

62. The method according to claim 52, wherein the number of pulses of each pulse train is varied.

63. The method according to claim 2, wherein step (b) is performed by electrically stimulating different areas of the wall portion.

64. The method according to claim 63, wherein step (b) is performed by stimulating the areas of the wall portion with electric pulses.

HtHlFIED SHEET (RUiI i1|

65. The method according to claim 64, wherein the wall portion includes muscle fibers, and step (b) is performed by stimulating the wall portion including the muscle fibers with the electric pulses.

66. The method according to claim 63, further comprising providing at least one electrical element engaging the wall portion.

67. The method according to claim 66, further comprising providing a plurality of electrical elements engaging the wall portion.

68. The method according to claim 67, further comprising placing the electrical elements in a fixed orientation relative to one another.

69. The method according to claim 68, further comprising providing a structure holding the electrical elements in the fixed orientation.

70. The method according to claim 69, wherein the electrical elements form an elongate pattern of electrical elements with two opposite short ends, further comprising applying the structure on the patient's heart so that the elongate pattern of electrical elements extends along the wall portion of the heart in the direction of the flow in the patient's lumen and the elements abut the respective areas of the wall portion.

71. The method according to claim 69, further comprising electrically energizing the electrical elements.

72. The method according to claim 71 , wherein each electrical element is cyclically energized with electric pulses.

73. The method according to claim 72, wherein the electrical elements are energized so that a number or groups of the electrical elements are energized at the same time.

"^■"ⁿ Sήttι

74. The method according to claim 72, wherein the electrical elements are energized one at a time in sequence or groups of the electrical elements are sequentially energized, either randomly or in accordance with a predetermined pattern.

75. The method according to claim 72, further comprising applying the electrical elements on the patient's heart so that the electrical elements form an elongate pattern of electrical elements extending along the wall portion of the heart in the direction of the blood flow in the patient's lumen and the elements abut the respective areas of the wall portion.

76. The method according to claim 72, wherein the electrical elements are successively energized along the elongate pattern of electrical elements.

77. The method according to claim 76, wherein the electrical elements are successively energized along the elongate pattern of electrical elements in a direction opposite to that of the flow in the patient's lumen.

78. The method according to claim 76, wherein the electrical elements are successively energized along the elongate pattern of electrical elements in the same direction as that of the flow in the patient's lumen.

79. The method according to claim 76, wherein the electrical elements are energized so that electrical elements currently energized form at least one group of adjacent energized electrical elements.

80. The method according to claim 79, wherein the elements in the group of energized electrical elements form a path of energized electrical elements.

81. The method according to claim 80, wherein the path of energized electrical elements extends at least in part around the patient's heart.

RBHlFED SHEET (RULE M)

82. The method according to claim 81 , wherein the path of energized electrical elements extends completely around the patient's heart.

83. The method according to claim 79, wherein the elements in the group of energized electrical elements form two paths of energized electrical elements extending opposite to each other.

84. The method according to claim 83, wherein the two paths of energized electrical elements extend on mutual sides of the patient's heart and at least substantially transverse to the direction of flow in the patient's heart.

84. The method according to claim 74, wherein the electrical elements are applied on the patient's heart in a series of groups of elements extending along the patient's heart in the direction of flow in the patient's lumen.

85. The method according to claim 84, wherein the groups of electrical elements in the series of groups are successively energized in a direction opposite to that of the flow in the patient's lumen.

86. The method according to claim 84, wherein the groups of electrical elements in the series of groups are successively energized in the same direction as that of the flow in the patient's lumen.

87. The method according to claim 84, wherein the electrical elements of each group of electrical elements form a path of elements extending at least in part around the patient's heart.

88. The method according to claim 87, wherein the path of electrical elements of each group of elements extends completely around the patient's heart.

frøfflS⁾ SHEET (RUUiIf

89. The method according to claim 84, wherein the electrical elements of each group of electrical elements form two paths of elements extending on mutual sides of the patient's heart.

90. The method according to claim 89, wherein the two paths of electrical elements of each group of elements extend at least substantially transverse to the direction of flow in the patient's lumen.

91. The method according to claim 2, wherein step (b) is performed by thermally stimulating the wall portion.

92. The method according to claim 91 , wherein step (b) is performed by cooling the wall portion to cause contraction of the wall portion.

93. The method according to claim 92, wherein step (a) is performed to at least restrict the flow in the lumen, and step (b) is performed by cooling the wall portion to cause contraction of the wall portion.

94. The method according to claim 93, wherein step (b) is performed by cooling the wall portion to cause contraction of the wall portion, so that the flow in the lumen is at least further restricted but not stopped.

95. The method according to claim 93, wherein step (b) is performed by cooling the wall portion to cause contraction thereof so that the flow in the lumen is stopped.

96. The method according to claim 92, further comprising heating the wall portion, when the wall portion is compressed and contracted, to cause expansion of the wall portion.

97. The method according to claim 92, wherein the wall portion includes a blood vessel and step (b) is performed by cooling the blood vessel to cause contraction thereof, or by heating the blood vessel to cause expansion thereof.

tf≥iSJ

98. The method according to claim 2, further comprising 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 stimulation device.

99. The method according to claim 98, further comprising operating the control device by the patient to control the compression device and/or stimulation device.

100. The method according to claim 99, wherein the control device comprises a hand-held wireless remote control that is operated by the patient.

101. The method according to claim 98, wherein the control device comprises an internal control unit, further comprising implanting in the patient the internal control unit and controlling by the internal control unit the compression device and/or stimulation device.

102. The method according to claim 101 , wherein the internal control unit is programmable.

103. The method according to claim 102, wherein the control device comprises an external control unit outside the patient's body, further comprising controlling by the external control unit the compression device and/or stimulation device.

104. The method according to claim 103, further comprising using the external control unit to program the implanted internal control unit.

105. The method according to claim 104, wherein the internal control unit is programmable for controlling the compression device and/or stimulation device over time.

RBHlFED SHEET 0HJLE 91)

106. The method according to claim 104, further comprising controlling by the internal control unit the compression device over time in accordance with an activity schedule program.

107. The method according to claim 102, wherein the internal control unit comprises a microprocessor.

108. The method according to claim 98, further comprising calibrating the compression of the wall portion by controlling the stimulation device to stimulate the wall portion while controlling the compression device to adjust the compression of the wall portion until the desired restriction of the flow in the lumen is obtained.

109. The method according to claim 98, further comprising implanting at least one sensor and controlling by the control device the compression device and/or stimulation device in response to signals from the sensor.

110. The method according to claim 109, wherein at least one physical parameter of the patient is directly or indirectly sensed by the sensor.

111. The method according to claim 109, further comprising implanting in the patient a medical implant, wherein at least one functional parameter of the medical implant is directly or indirectly sensed by the sensor.

112. The method according to claim 110, wherein the sensor comprises a pressure sensor that senses a pressure in the patient's body.

113. The method according to claim 112, further comprising controlling the compression device by the control device to change the compression of the patient's wall portion in response to the pressure sensor sensing a predetermined value.

114. The method according to claim 109, wherein the control device comprises an internal control unit, further comprising implanting in the patient

FIGURED SHEET (Rϋiii1| the internal control unit and directly controlling by the internal control unit the compression device and/or stimulation device in response to signals from the sensor.

115. The method according to claim 109, wherein the control device comprises an external control unit outside the patient's body, further comprising controlling by the external control unit the compression device and/or stimulation device in response to signals from the sensor.

116. The method according to claim 109, wherein the control device produces an indication in response to signals from the sensor.

117. The method according to claim 116, wherein the indication comprises a sound signal or displayed information.

118. The method according to claim 2, wherein step (a) is performed by mechanically or hydraulically compressing the wall portion.

119. The method according to claim 118, wherein step (a) is performed by mechanically or hydraulically compressing the wall portion in a nonmagnetic and/or non-manual manner.

120. The method according to claim 118, wherein step (a) is performed by compressing the wall portion so that the through-flow area of the lumen assumes a size in the compressed state small enough to cause the flow in the lumen to stop when step (b) is performed.

121. The method according to claim 118, wherein step (a) is performed by bending the heart.

122. The method according to claim 118, wherein step (a) is performed by clamping the heart between at least two elements positioned on different sides of the heart.

HtHlFIED SHEET (RUiI i1|

123. The method according to claim 118, wherein step (a) is performed by clamping the heart between an element and the bone or tissue of the patient.

124. The method according to claim 118, wherein step (a) is performed by rotating at least two elements positioned on different sides of the heart.

125. The method according to claim 118, wherein step (a) is performed by clamping the heart between at least two articulated clamping elements positioned on different sides of the heart.

126. The method according to claim 118, further comprising implanting in the patient a main reservoir containing a predetermined amount of hydraulic fluid and a compression device engaging the wall portion and having an expandable cavity, wherein step (a) is performed by distributing hydraulic fluid from the main reservoir to increase the volume of the cavity to compressed the wall portion.

127. The method according to claim 126, wherein the main reservoir comprises first and second wall portions, and step (a) is performed by displacing the first and second wall portions towards each other to decrease the volume of the main reservoir, so that fluid is distributed from the main reservoir to the cavity.

128. The method according to claim 127, wherein at least one of a magnetic device, a hydraulic device or an electric control device displaces the first and second wall portions of the main reservoir toward each other.

129. The method according to claim 126, further comprising implanting a reverse servo that distributes hydraulic fluid from the main reservoir to the cavity.

130. The method according to claim 129, wherein the main reservoir comprises first and second wall portions, and the reverse servo displaces the

HtHlFIED SHEET (RULI §1| first and second wall portions towards each other to decrease the volume of the main reservoir, so that fluid is distributed from the main reservoir to the cavity.

131. The method according to claim 130, wherein the reverse servo comprises an expandable servo reservoir containing servo fluid and having 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, and the first and second wall portions of the servo reservoir are operatively connected to the first and second wall portions of the main reservoir, so that the volume of the main reservoir is changed when the volume of the servo reservoir is changed.

132. The method according to claim 131 , further comprising 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.

133. The method according to claim 131 , wherein the first and second wall portions of the servo reservoir are displaced relative to each other by manual manipulation.

134. The method according to claim 131, wherein the first and second wall portions of the servo reservoir are displaced relative to each other by a magnetic device, a hydraulic device, or an electric control device.

135. The method according to claim 131 , wherein the reverse servo comprises a fluid supply reservoir hydraulically connected to the servo reservoir to form a closed conduit system for the servo fluid.

136. The method according to claim 126, further comprising implanting in the patient a pump that pumps fluid between the main reservoir and the cavity.

BSCTHEDSHST(RUUfI)

137. The method according to claim 136, wherein the pump comprises a first activation member that activates the pump to pump fluid from the main reservoir to the cavity and a second activation member that activates the pump to pump fluid from the cavity to the main reservoir.

138. The method according to claim 137, wherein the first and second activation members are operated by manual manipulation thereof.

139. The method according to claim 137, wherein at least one of the activation members operates when subjected to an external predetermined pressure.

140. The method according to claim 137, wherein at least one of the first and second activating members are operated by magnetic means, hydraulic means, or electric control means.

141. The method according to claim 138, further comprising implanting a fluid conduit between the pump and the cavity, the main reservoir forming part of the conduit.

142. The method according to claim 141 , wherein the conduit and pump is devoid of any non-return valve.

143. The method according to claim 142, wherein the main reservoir forms a fluid chamber with a variable volume, and step (a) is performed by reducing the volume of the chamber so that fluid is pumped from the chamber to the cavity.

144. The method according to claim 143, wherein the pump comprises a movable wall of the main reservoir for changing the volume of the chamber.

145. The method according to claim 144, further comprising implanting a motor for driving the pump.

UBWlE) SHEET (RULlH!

146. The method according to claim 2, wherein step (a) is performed by using a compression device and step (b) is performed by using a stimulation device, further comprising forming the compression and stimulation devices in an operable compression/stimulation unit.

147. The method according to claim 146, further comprising 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.

148. The method according to claim 147, further comprising directly using the wireless energy in connection with the operation of the compression/stimulation unit as the wireless energy is being transmitted.

149. The method according to claim 148, wherein the wireless energy comprises an electric, an electromagnetic or a magnetic field, or a combination thereof, or electromagnetic waves.

150. The method according to claim 149, further comprising implanting in the patient an electric motor or pump operatively connected to the compression device and directly powering the motor or pump by wireless energy in the form of a magnetic or an electromagnetic field.

151. The method according to claim 147, wherein the wireless energy comprises energy of a first form, further comprising transmitting the energy of the first form into energy of a second form and operating the compression/stimulation unit with the energy of the second form.

152. The method according to claim 151 , wherein the energy of the second form is different than the energy of the first form.

153. The method according to claim 151 , wherein the energy of the second form comprises electric energy.

RBHVED SHEET 0HJLE 91)

154. The method according to claim 151 , wherein the compression/stimulation unit is directly operated with the energy of the second form in a non-magnetic, non-thermal or non-mechanical manner.

155. The method according to claim 151 , wherein the energy of the first form is directly or indirectly transformed into the energy of the second form.

156. The method according to claim 155, further comprising providing a motor for operating the compression device and powering the motor with the energy of the second form.

157. The method according to claim 156, wherein the compression device is operable to perform at least one reversible function, further comprising reversing the function by using the motor.

158. The method according to claim 156, further comprising shifting polarity of the energy of the second form to reverse the motor.

159. The method according to claim 156, further comprising directly powering the motor with the transformed energy of the second form, as the energy of the second form is being transformed from the energy of the first form.

160. The method according to claim 155, wherein the wireless energy of the first form comprises sound waves and the energy of the second form comprises electric energy.

161. The method according to claim 173, further comprising implanting in the patient a source of energy for storing the energy of the second form and supplying energy from the source of energy in connection with the operation of the compression/stimulation unit.

HtHlFED SHEST (RULiH!

162. The method according to claim 161, wherein the source of energy comprises an accumulator.

163. The method according to claim 162, wherein the accumulator comprises at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

164. The method according to claim 151 , further comprising implanting in the patient a source of energy for supplying energy for the operation of the compression/stimulation unit and a switch for switching the energy supplied by the source of energy.

165. The method according to claim 164, further comprising using the energy of the second form to operate the switch to switch from an "off' mode, in which the source of energy is not in use, to an "on" mode, in which the source of energy supplies energy for the operation of the compression/stimulation unit.

166. The method according to claim 151 , further comprising implanting in the patient a stabilizer for stabilizing the energy of the second form.

167. The method according to claim 166, wherein the energy of the second form comprises electric current and the stabilizer comprises at least one capacitor.

168. The method according to claim 147, wherein the wireless energy is transmitted in at least one wireless signal.

169. The method according to claim 168, wherein the signal comprises a wave signal.

170. The method according to claim 169, wherein the wave signal comprises an electromagnetic wave signal including one of an infrared light signal, a visible light signal, an ultra violet light signal, a laser signal, a micro

HtHlFIB⁾ SHEET (RULi §1) wave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal.

171. The method according to claim 169, wherein the wave signal comprises a sound or ultrasound wave signal.

172. The method according to claim 168, wherein the signal comprises a digital or analogue signal, or a combination of a digital and analogue signal.

173. The method according to claim 151 , wherein the energy of the first form comprises an electric, an electromagnetic or a magnetic field, or a combination thereof.

174. The method according to claim 147, wherein the wireless energy comprises an electric, an electromagnetic or a magnetic field, or a combination thereof, further comprising transmitting the wireless energy in pulses or digital pulses, or a combination of pulses and digital pulses.

175. The method according to claim 151 , wherein the energy of the first form is transformed into a direct current or pulsating direct current, or a combination of a direct current and pulsating direct current.

176. The method according to claim 151 , wherein the energy of the first form is transformed into an alternating current or a combination of a direct and alternating current.

177. The method according to claim 151 , wherein one of the energy of the first form and the energy of the second form comprises magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, photo energy, nuclear energy or thermal energy.

178. The method according to claim 151 , wherein 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.

REGTFIED SHEET (RULi i1|

179. The method according to claim 146, further comprising providing a control device that controls the compression/stimulation unit.

180. The method according to claim 179, further comprising operating the control device by the patient.

181. The method according to claim 180, wherein the control device comprises a manually operable switch for switching on and off the compression/stimulation unit, further comprising subcutaneously implanting the switch in the patient.

182. The method according to claim 180, wherein the control device comprises a hand-held wireless remote control operable by the patient, further comprising controlling the compression/stimulation unit by the patient operating the remote control to adjust the stimulation intensity and/or adjust the compression of the wall portion.

183. The method according to claim 179, wherein the control device comprises a remote control that controls the compression/stimulation unit from outside the patient's body.

184. The method according to claim 183, wherein the remote control comprises a wireless remote control.

185. The method according to claim 184, wherein the wireless remote control transmits at least one wireless control signal for controlling the compression/stimulation unit.

186. The method according to claim 185, wherein the control signal comprises a frequency, amplitude, phase modulated signal or a combination thereof.

HtHlFIED SHEET (RULIfIf

187. The method according to claim 185, wherein the control signal comprises an analogue or a digital signal, or a combination of an analogue and digital signal.

188. The method according to claim 185, wherein the wireless remote control transmits a carrier signal that carries the control signal.

189. The method according to claim 188, wherein the carrier signal comprises digital, analogue or a combination of digital and analogue signals.

190. The method according to claim 189, wherein the signals comprise wave signals.

191. The method according to claim 185, wherein the control signal comprises a wave signal comprising one of 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 and a gamma radiation signal.

192. The method according to claim 185, wherein the control signal comprises an electric or magnetic field, or a combined electric and magnetic field.

193. The method according to claim 187, wherein the wireless remote control transmits an electromagnetic carrier wave signal that carries the digital or analogue control signal.

194. The method according to claim 146, further comprising implanting in the patient an operation device and operating the compression/stimulation unit with the operation device.

195. The method according to claim 194, further comprising providing a magnet and activating the operation device with the magnet.

^■Λtk.% 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.

202. The method according to claim 201 , further comprising implanting a powered operation device for operating the compression device. ^•

203. The method according to claim 202, wherein the operation device comprises a powered hydraulic operation device.

204. The method according to claim 202, wherein the operation device comprises an electrically powered operation device.

205. The method according to claim 204, wherein the operation device comprises an electric motor.

206. The method according to claim 202, further comprising 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.

207 The method according to claim 201 , further comprising 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, 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.

208. The method according to claim 207, wherein the wireless energy is transformed into a storable energy different from the wireless energy.

RECTHED SHEET (RUUfIf

196. The method according to claim 195, wherein the magnet activates the operation device from outside the patient's body.

197. The method according to claim 194, wherein the operation device comprises a motor.

198. The method according to claim 197, further comprising providing a source of energy and powering the motor with energy released from the source of energy.

199. The method according to claim 146, further comprising implanting a source of energy, releasing energy from the source of energy and using the released energy in connection with the operation of the compression/stimulation unit.

200. The method according to claim 199, wherein the source of energy comprises a battery.

201. The method for controlling a flow of blood in a lumen formed by a tissue wall of a patient's heart, the method comprising the steps of: inserting a needle like tube into the thorax of the patients body, using the needle like tube to fill the thorax with gas thereby expanding the thoraxial cavity, placing at least two laparoscopical trocars in the patient's body, inserting a camera through one of the trocars into the thorax, 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

209. The method according to claim 208, wherein the storable energy comprises electric energy.

210. The method according to claim 201 , further comprising 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.

211. The method according to claim 210, further comprising transforming the wireless energy into electrical energy inside the patient's body by an implanted energy-transforming device and using the electrical energy in connection with the operation of the compression device and/or stimulation device.

212. The method according to claim 211 , further comprising directly using the electrical energy 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.

213. The method according to claim 210, further comprising controlling the external source of energy from outside the patient's body to release nonmagnetic wireless energy, and using the released non-magnetic wireless energy for operating the compression device and/or stimulation device.

214. The method according to claim 210, further comprising controlling the external source of energy from outside the patient's body to release electromagnetic wireless energy, and using the released electromagnetic wireless energy for operating the compression device and/or stimulation device.

215. The method according to claim 2, wherein step (a) is performed by compressing any wall portions of a series of wall portions of the heart's tissue wall, respectively.

FIGURED SHEET (Rϋili1|

216. The method according to claim 215, wherein the wall portions of the series of wall portions are compressed in random or in accordance with a predetermined sequence.

217. The method according to claim 215, 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.

218. The method according to claim 215, wherein step (b) is performed by stimulating any compressed wall portions of the series of wall portions.

219. The method according to claim 215, wherein the wall portions of the series of wall portions are compressed, and 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 and/or other bodily matter in the lumen of the patient's heart.

220. The method according to claim 218, wherein step (a) is performed by compressing all of the wall portions of the series of wall portions, and step (b) is performed by stimulating any compressed wall portions in random or in accordance with a predetermined sequence to close the heart's lumen.

221. The method according to claim 1 , wherein step (a) and step (b) are performed independently of each other.

222. The method according to claim 1 , wherein step (a) and step (b) are performed simultaneously.

223. The method for controlling a flow of blood in a lumen formed by a tissue wall of a patient's heart, the method comprising the steps of: cutting the skin opening the thorax

HtHlFIED SHEET (RUiI i1| inserting a dissecting tool 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.

224. The method according to claim 210, further comprising providing an internal energy source, wherein said wireless energy is transmitted from an external energy source located outside the patient and is received by the internal energy source located inside the patient, the internal energy source being connected to at least one of the constriction and stimulation devices for directly or indirectly supplying received energy thereto, the method comprising the steps of:

- determining an energy balance between the energy received by the internal energy source and the energy used for the at least one of the stimulation and constriction devices device, and

225. The method according to claim 224, wherein the wireless energy is transmitted inductively from a primary coil in the external energy source to a secondary coil in the internal energy receiver.

226. The method according to claim 224, wherein a change in said energy balance is detected, and the transmission of wireless energy is controlled based on said detected energy balance change.

227. The method according to claim 224, wherein a difference is detected between energy received by said internal energy receiver and

tf≥iSJ energy used for the medical device, and the transmission of wireless energy is controlled based on said detected energy difference.

228. The method according to claim 226, wherein the amount of transmitted wireless energy is decreased if the detected energy balance change implies that the energy balance is increasing, or vice versa.

229. The method according to claim 228, wherein the decrease/increase of energy transmission corresponds to a detected change rate.

230. The method according to claim 227, wherein the amount of transmitted wireless energy is decreased if the detected energy difference implies that the received energy is greater than the used energy, or vice versa.

231. The method according to claim 230, wherein the decrease/increase of energy transmission corresponds to the magnitude of said detected energy difference.

232. The method according to claim 226, wherein the energy used for the at least one of the stimulation and constriction devices is stored in at least one energy storage device of the device.

233. The method according to claim 226, wherein substantially all the energy used for the at least one of the stimulation and constriction devices i is consumed to operate the device.

234. The method according to claim 232, wherein the energy is consumed after being stabilised in at least one energy stabilising unit of the device.

odea

235. The method according to claim 227, wherein the energy used for the at least one of the stimulation and constriction devices is stored in at least one energy storage device of the device.

236. The method according to claim 227, wherein substantially all the energy used for the at least one of the stimulation and constriction devices i is consumed to operate the device.

237. The method according to claim 236, wherein the energy is consumed after being stabilised in at least one energy stabilising unit of the device.

238. The method according to claim 210, comprising an internal energy source located inside the patient, connected to the at least one of the stimulation and constriction devices for directly or indirectly supplying received energy thereto, the method comprising the steps of:

- determining an energy balance between the energy sent by the external energy source and the energy received by the internal energy source, and

239. The method according to claim 238, wherein the wireless energy is transmitted inductively from a primary coil in the external energy source to a secondary coil in the internal energy receiver.

240. The method according to claim 238, wherein a change in said energy balance is detected, and the transmission of wireless energy is controlled based on said detected energy balance change.

241. The method according to claim 238, wherein a difference is detected between the energy sent by the external energy source and the energy received by said internal energy receiver, and the transmission of wireless energy is controlled based on said detected energy difference.

frøfflS⁾ SHEET (RUUiIf

242. The method according to claim 240, wherein the amount of transmitted wireless energy is decreased if the detected energy balance change implies that the energy balance is increasing, or vice versa.

243. The method according to claim 242, wherein the decrease/increase of energy transmission corresponds to a detected change rate.

244. The method according to claim 241 , wherein the amount of transmitted wireless energy is decreased if the detected energy difference implies that the received energy is greater than the used energy, or vice versa.

245. The method according to claim 244, wherein the decrease/increase of energy transmission corresponds to the magnitude of said detected energy difference.

246. The method according to claim 238, wherein said wireless energy is transmitted by means of a primary coil in the external energy source and received inductively by means of a secondary coil in an internal energy source, the internal energy source is connected to the medical device for directly or indirectly supplying received energy thereto, wherein feedback control information (S) is transferred from the secondary coil to the primary coil by switching the secondary coil on and off to induce a detectable impedance load variation in the primary coil encoding the feedback control information, wherein the feedback control information relates to the energy received by the internal energy source and is used for controlling the transmission of wireless energy from the external energy source.

247. The apparatus according to claim 246, wherein the external energy source further comprises an electronic circuit for comparing the feedback information with the amount of energy transmitted by the external energy source.

HtHlFIED SHEET (RULiH!

248. The method according to claim 247 , wherein the electronic circuit comprises an analyzer, analyzing the amount of energy being transmitted and receiving the feedback information related to the amount of energy received in the receiver, and further determining the energy balance by comparing the amount of transmitted energy and the feedback information related to the amount of received energy.

249. The method according to claim 248, wherein the external energy source is using said feedback information to adjust the level of said transmitted energy.

250. The method according to claim 224, wherein said wireless energy being transmitted by means of a primary coil in an external energy source and received inductively by means of a secondary coil in an internal energy source, the internal energy receiver being connected to the medical device for directly or indirectly supplying received energy thereto, wherein feedback control information (S) is transferred from the secondary coil to the primary coil by switching the secondary coil on and off to induce a detectable impedance load variation in the primary coil encoding the feedback control information, where the feedback control information relates to said energy balance.

251. The method according to claim 210, comprising the steps of;

-transmitting wireless energy from the external energy source comprising a coil placed externally to the human body, further comprising an implantable energy receiver to be placed internally in the human body and an electric circuit connected to the external coil, the coil

- supplying electrical pulses to transmit the wireless energy, the electrical pulses having leading and trailing edges, the electric circuit,

^■Λtk.% -varying first time intervals between successive leading and trailing edges and/or second time intervals between successive trailing and leading edges of the electrical pulses, thus

- varying the power of the transmitted wireless energy, the energy receiver, and

- receiving the transmitted wireless energy having a varied power.

252. The method according to claim 251 , wherein the electric circuit;

- delivering the electrical pulses to remain unchanged except varying the first and/or second time intervals.

253. The method according to claim 251 , wherein the electric circuit has a time constant,

- varying the first and second time intervals only in the range of the first time constant, so that when the lengths of the first and/or second time intervals are varied,

- varying the transmitted power over the coil.

HtHlFIB⁾ SHEET (RULi §1)