WO2002058605A1

WO2002058605A1 - Device for reversibly cooling and heating biological tissues

Info

Publication number: WO2002058605A1
Application number: PCT/EP2002/000754
Authority: WO
Inventors: Patrick Schauerte
Original assignee: Patrick Schauerte
Priority date: 2001-01-25
Filing date: 2002-01-25
Publication date: 2002-08-01
Also published as: DE10103289A1

Abstract

The invention relates to a device which can be permanently and rigidly positioned in or on the heart of a living being in a location of fixture, such as the atrioventricular node, the sinus node, the myocardial conduction system or the autonomic nervous system of the human heart by means of a fixing device. The device is further provided with a temperature influencing device for changing the temperature in an area of the heart restricted to the surroundings of the location of fixture.

Description

Device for the reversible cooling and heating of biological tissues

The invention relates to a device which can be implanted in or on the heart of a living being, by means of which the heart rate and heart pumping force can be reversibly increased or decreased by local cooling and / or warming of the stimulation and conduction tissue of the heart or of autonomous nerve fibers.

Unwanted sinus tachycardia or atrial fibrillation is a significant clinical problem, especially in patients with limited ventricular pumping power. In the context of tachycardia, the diastolic filling time of the left ventricle is reduced and the cardiac output is consecutively reduced. The heart muscle is mainly supplied diastolic with oxygen through the coronary arteries. In the context of tachycardia, the diastole time and thus the effective oxygenation of the heart muscle is reduced while the myocardial oxygen demand is increased due to the rapid ventricular contraction. Supraventricular tachycardias in the context of acute, cardiac ischemia also represent a therapeutic challenge in patients with a restricted ventricular pump function. Conventionally used medications for the treatment of such supraventricular tachycardias are Digitalis glycosides, beta-receptor blockers and calcium channel blockers. However, many of the heart failure patients are already being treated with digitalis glycosides, so that primarily β-blockers and calcium channel blockers are available to lower the heart rate in supraventricular tachycardia. However, at doses that lower the heart rate, these substances have an extremely negative inotropic effect, which can lead to a further weakening of the pumping power of the heart and to a critical drop in arterial blood pressure.

In addition to medication-influencing the heart activity, it is known to control the heart rate by so-called "pacemakers". These devices send electrical impulses via an electrode that leads to the heart, which 'help to stabilize the beat frequency. The widespread use of pacemakers and their success has led to the fact that probe-like elements that can be inserted into the body and through which signals affecting cardiac activity or other influences can be transmitted to the heart are also referred to as electrodes when they actually do not have any electrical signals be transmitted.

It is also known that the biological activity of body tissues is essentially dependent on the tissue temperature. The normal human tissue temperature is 36 ° C to 37 ° C. A cooling down of the human body leads to a reduced metabolic activity but also to a reduced oxygen consumption of the heart muscle. Therapeutically, hypothermia of the body is used to reduce the need for oxygen during heart operations. Here, the Heart pump function and oxygenation of the blood partially or completely by a heart-lung machine. In order to reduce the organ damage of a reduced cardiac output, the entire blood volume and thereby indirectly the human body is cooled to approx. 28-30 ° C.

The heart is capable of spontaneous impulse formation through spontaneous diastolic depolarization, predominantly of the sinus node. The electrical impulse generated in the sinus node is then passed through the atria to the atrioventricular border. This border is characterized by the two atrioventricular valves, which are anchored in a connective tissue suspension device, the so-called valve ring. More than 98% of the atrioventricular border consists of such electrically non-conductive connective tissue. Only at one point, the so-called atrioventricular node (AV node), which merges into the His bundle, there is a conduction of the electrical excitation from the atria to the heart chambers. After the heart chambers, which are responsible for the generation of an arterial pulse wave, have been electrically excited via the AV node and the His bundle, the actual heart muscle contraction then occurs via a cellular electromechanical coupling.

A cooling of the specific stimulation and conduction tissue of the heart causes a slowed down myocardial electrical stimulation, which is clinically noticeable in hypothermic patients in a slowdown of the sinus node frequency. In addition, cooling the atrial and ventricular tissue leads to one delayed atrial and ventricular electrical excitation, which can be seen in part from the wide QRS complexes in the surface ECG. Hypothermia of the body also leads to a cooling of the atrioventricular node and the downstream His bundle, which can manifest itself clinically in a slowed down atrioventricular conduction up to AV blocking.

In contrast, an increase in temperature leads to an acceleration of metabolic processes in the human body. So it happens e.g. in the context of sepsis, among other things, regularly by increasing the temperature up to 40 ° C to 41 ° C to accelerate the heart rate (sinus tachycardia) or supraventricular tachycardia and to accelerate the atrioventricular conduction via the AV node and the His bundle.

The object of the invention was to provide a device with which a targeted influencing of the heart rate can be carried out more effectively than with the known means.

This object is achieved according to the invention by a device which can be permanently and permanently positioned with a fastening device, by means of which it can be permanently positioned in or on the heart of a living being at a fastening location, such as the atrioventricular node, sinus node, myocardial conduction system or autonomous nervous system of the human heart Temperature influencing device for changing the temperature in an area of the heart which is restricted to the surroundings of the attachment site Is provided. With such a device, a thermoregulation device is available which can be chronically implanted transvascularly or epicardially or extravascularly via a thoracotomy in the atrioventricular (AV) node, sinus node or myocardial conduction system or in the autonomous nervous system. As a result, targeted local cooling or warming of these tissues can be carried out and the cardiac activity can be influenced particularly effectively. In practical use, the device according to the invention for local cooling / heating of the AV node in the AV node or its atrial inputs (so-called “slow and fast pathway”) or in the atrial myocardium directly adjacent to the AV node or on the patient's Bundle fixed. The placement is under X-ray fluoroscopy or other imaging methods such as

Magnetic resonance imaging, computer tomography, ultrasound or electromagnetic location and control systems (navigation systems) performed. The placement in the AV node can be anatomically oriented. The probe is fixed between the mouth of the coronary vein sinus and the His bundle in the septal atrial myocardium. Alternatively, the AV node can be identified on the basis of monophase action potentials or bipolar AV node electrograms, which are derived from the tip of the thermoregulation device or a second auxiliary electrode. An alternative placement technique for an indwelling electrode is placement in the His bundle.

It is known that the control and positioning of indwelling electrodes in / on the myocardium or the vessels can be technically difficult, especially if the target areas are small or target locations are difficult to access is. Reaching and identifying these destinations is often easier with more controllable and deflectable catheters like those at

Cardiac catheter examinations or electrophysiological examinations on the patient can be used. However, these cannot remain permanently in the body. In order to enable placement of an indwelling electrode at the target location, it may therefore be necessary to first identify the target location with controllable electrode catheters. This can e.g. by deriving monophasic action potentials, local electrical myocardial or nerve stimulation, or by catheters that generate an anatomical image themselves (ultrasound catheter) or that can identify a destination with the help of imaging procedures.

In order to place and anchor a permanent dwelling electrode at the same location after identification of the target location, it is proposed according to a further aspect of the invention to proceed as follows when placing a device according to the invention in the body of a living being:

- Inserting a catheter into the body to the place where the

Temperature transmission device is to be positioned, the catheter having a through-channel which leads from an insertion opening lying outside the body when the catheter is fully positioned to an outlet opening of the catheter which is arranged in the region of the placement site when the catheter is fully positioned, Anchoring a guide device running through the passage channel of the catheter at the place of placement,

Removal of the catheter from the body while the guide device remains in the body,

Inserting a temperature control element into the body, the temperature control element being guided by the guide device,

- Remove the guide device from the body.

The invention provides for the placement of the temperature transmission element as an auxiliary device, a catheter which, in addition to the possibility of deriving monophasic action potentials, the possibility of electrical / magnetic myocardial or nerve stimulation, the possibility of imaging or location with the aid of an imaging method, also has a central through-channel , Such a through channel is usually referred to in medical terminology as the "inner lumen". In the case of a catheter used in accordance with the invention, the distal end is at the tip of the catheter which is in direct contact with the cile structure, while its proximal end is at the catheter shaft outside the body. In principle, each stimulation / cardiac catheter can be provided with such an (additional) channel (inner lumen). After the destination has been identified by the respective catheter (the respective catheter technique), the catheter is left at the effectively identified stimulation site. Now, through the central inner lumen, a guide device, for example in the form of a guide wire, with a tip for temporary anchoring in the myocardium or nerves or vessel such as a sharp tip, a miniaturized screw, one or more barbs or a reversibly actively or passively expandable metal body, which is initially implanted in the target tissue with the catheter lying down. The catheter is then removed via the guide device now lying, which is further anchored in the target tissue. Now the permanent indwelling probe is pushed over the lying wire to the target location and anchored in it upon contact with the target tissue. The guidewire is then removed atraumatically by pulling or screwing.

The principle of placing catheters or indwelling electrodes is known. For example, it is used in percutaneous angioplasty of narrowed vessels (PTCA) or for the placement of pacemaker electrodes for biventricular stimulation. This principle has been further developed by the invention in that the guide element is anchored in the target tissue by means of specific anchoring mechanisms at the wire tip and remains there until the temperature transfer element has been completely placed. Such an auxiliary device can in principle also be used for the placement of other indwelling electrodes e.g. pacemaker stimulation, internal defibrillators or electrodes for monitoring biological parameters.

Local cooling of the AV node or His bundle of tissues to a temperature of approx. 20 ° C to 35 ° C leads to a slowed down atrioventricular conduction and thereby reduces the ventricular rate supraventricular tachycardia or atrial fibrillation.

Selective local cooling of the AV node can lower the ventricular rate in supraventricular tachycardia without reducing the pumping force of the ventricles.

Conversely, local warming of the AV node to approx. 39 ° C to 41 ° C accelerates the atrioventricular conduction.

For local cooling / heating of the sinus node, a thermoregulation device according to the invention is fixed in the sinus node or in the atrial myocardium directly adjacent to the sinus node. The placement is carried out under X-ray fluoroscopy or other imaging methods such as, for example, magnetic resonance tomography, computed tomography, ultrasound or electromagnetic location and control systems (navigation systems) or ultrasound. Placement in the sinus node can be done electrophysiologically: Since the heart excitation originates from the sinus node, the location of the earliest atrial excitation (mapping) and the electrode then at this point are sought by deriving a bipolar electrogram from the tip of the thermoregulation electrode or a second controllable auxiliary catheter Implanted in place. Local cooling of the sinus node to a temperature of approximately 20 ° C to 35 ° C leads to a slowed spontaneous diastolic depolarization of the sinus node and consecutively to a reduction in the sinus node requirement. Conversely, local warming of the sinus node to approx. 39 ° C to 41 ° C triggers an acceleration of the sinus node frequency.

For local cooling / warming of parasympathetic cardiac nerves that innervate the atrioventricular node, the thermoregulation electrode is located either in the right or left jugular vein, the superior vena cava, in the proximal coronary vein sinus or on the posterior edge of the mouth of the coronary vein sinus or in the right or left pulmonary artery implanted.

For local cooling / warming of parasympathetic cardiac nerves that innervate the sinus node, the thermoregulation electrode is implanted either in the right or left jugular vein, the superior vena cava, the right or left pulmonary artery or in the right atrium opposite the ventral right atrial nerve plexus.

For local cooling / warming of parasympathetic cardiac nerves that innervate the atria or ventricles, the thermoregulation electrode is implanted in either the right or left jugular vein, the superior vena cava, in the distal coronary artery sinus or the right or left pulmonary artery.

The thermoregulation electrode is implanted in the right or left artery or subclavian vein for local cooling / warming of sympathetic cardiac nerves that innervate the sinus node, the AV node, the atria or ventricles. For local cooling / warming of sympathetic cardiac nerves that will innervate the heart chambers Thermoregulation electrode implanted in the posterior and lateral coronary vein sinus (e.g. along the ventrolateral nerve).

A local cooling of the parasympathetic nerve tissue to a temperature of 20 ° C to 35 ° C or a local warming of sympathetic cardiac nerves to approx. 39 ° C to 41 ° C leads to an acceleration of the

Sinus node rate, the atrioventricular conduction as well as an increase in the atrial and ventricular pumping force as well as a reduction in the atrial and ventricular repolarization times.

Local warming of parasympathetic cardiac nerves to a temperature of 39 ° C to 41 ° C or local cooling of sympathetic cardiac nerves to approx. 20 ° C to 35 ° C causes a slowdown of the sinus node frequency, an extension of the atrioventricular conduction and a decrease in the atrial and ventricular pumping force. Cooling parasympathetic and sympathetic cardiac nerves can prolong the atrial refractory period and thus have a protective effect against atrial fibrillation, while warming parasympathetic or cooling sympathetic nerves that innervate the main ventricles can lead to an extension of the ventricular refractory period, which can prevent the occurrence of ventricular tachycardia can.

Further advantageous embodiments of the invention are specified in the dependent claims and are explained in more detail below on the basis of exemplary embodiments. The devices corresponding to the invention are each "thermoregulation devices" been designated. In the drawing, the various figures each schematically show the following:

Fig.l a thermoregulation device for influencing the heart rate and heart pumping force by means of local cooling and / or warming of the heart;

2 shows a representation of typical implantation locations of the thermoregulation device on a human heart,

3 - 6 steps in the placement of the thermoregulation device,

7 shows a step in the placement of a modification of the thermoregulation device,

8a - 8e different guide devices in the

Placement of the thermoregulation device.

Typically, the thermoregulation device 1 comprises a cold generation unit 3 and a heat generation unit 4, which is implanted subcutaneously or submuscularly in the region of the right-hand or left-hand pectoral muscles. In some cases, an abdominal implantation in / on the rectus sheath may be necessary.

In a typical variant, the refrigeration unit 3 has a compressor that a can pressurize gaseous fluid or a liquid fluid used to transmit the temperature generated in each case. Condensation coils run on the outside or in the outer shell of the thermoregulation device 1, in which the gas compressed by the compressor (for example CC1 ₂ F ₂ ) cools before it passes through a valve flap into an evaporation coil incorporated in the unit. The evaporation coil is flowed around by the temperature transfer fluid (typically H ₂ O), which is conveyed into a temperature transfer element 2 by a pump located in a circulation unit 7, not shown here.

In a typical embodiment, the heat generation unit 4 comprises a power generation device (not shown here) which, by means of electromagnetic waves via two electrodes (also not shown) arranged in the circulation unit 7, heats up a liquid cooling fluid used for temperature transfer.

The temperature transmission element 2 is connected to the circulation unit 7. It comprises a double lumen 9 for circulation and recirculation (circulation) of the cooling liquid. According to a modification, instead of a circulating cooling liquid, the thermoregulation element 2 can include any other heat / cold conductor that transfers the heat / cold supplied by the heat / cold generation unit 3 or 4 into the biological tissue.

In order to absorb heat along the temperature transfer element 2 in the course of the vessel avoid, it is provided with insulation 13 along its axis. Only at the tip of the temperature transmission element 2 is there a non-insulated surface on which the heat / cold conductor emerges from the temperature transmission element 2 and merges into an anchoring device 8.

The heat / cold conductor (double lumen 9) can initially be designed in the form of a flat cooling / heating plate 10 (e.g. double-lumen tubular screw) when it exits the temperature transfer element 2, which enables free heat / cold exchange on contact with the target tissue , Additionally or exclusively, however, the fastening device 8 itself consists of a cold / heat conductor, which is fixed in the biological target tissue and thus guarantees immediate cooling / heating of the target tissue.

At the tip of the temperature transmission element 2 there is also a temperature sensor 15 which measures the local tissue temperature and forwards this information to the measuring and comparison unit 6.

Another preferred embodiment uses Peltier elements (not shown) for local cooling. In this case, the heat / cold exchange takes place locally in the area of the probe tip of the temperature transfer element 2. The Peltier elements should be part of the tip of the temperature transmission element 2 itself, which is anchored in the structure to be cooled, or part of the distal sections of the temperature transmission element 2, which lie directly on or on the structure to be cooled. In alternative embodiments, the tip of the temperature transmission element 2 consists of a metal stent, also not shown here, which can be placed in tubular structures, preferably vessels, and deployed by pressure or self-insufflation. The known design of such a stent electrode enables the connection of several Peltier elements in order to increase the cooling capacity. The stent mesh or rings can consist of individual Peltier elements. By changing the direction of current flow, cooling or heating of a given half-ring of the stent can take place.

Such a stent electrode is particularly suitable for local cooling of myocardial, conduction or nerve tissue that is located along vessels. An example is the AV node or the parasympathetic inferior interatrial (AV node) plexus:

By placing a coil / electrode (stent) in the coronary vein sinus, the adjacent AV node or its posterior (anterior) input can be cooled or heated. Cooling or heating of the parasympathetic inferior interatrial (AV node) plexus can also be carried out in this way.

Such stent electrodes can be coated with various growth-inhibiting substances that delay the proliferation of vascular intima and thus prevent later occlusion of the vessel by the stent.

The cooling / heating methods shown here are only to be considered as examples. Basically can any cooling / heating method which is suitable according to the prior art and which can be miniaturized sufficiently can be used in the implantable thermoregulation device.

In addition to the device for heat / cold generation, the thermoregulation device according to the invention has measurement sensors which register biological measurement parameters such as heart rate, blood pressure, cardiac / thoracic impedance, oxygen saturation and the tissue temperature and pass them on to the measurement and comparison unit 6.

An atrial and / or ventricular screw electrode can be used to measure the heart rate. An alternative embodiment provides for a ("far-field") ECG to be derived between the distal portions of the temperature transmission element 2 and the housing of the device 1. The T wave is suppressed by signal filtering and the R wave signal is used to measure the ventricular heart rate. Likewise, the P wave for measuring the atrial signal can be filtered out alone or in addition. In this embodiment, a ventricular and / or atrial sensing electrode can be dispensed with.

The measurement sensors are connected to the measurement and comparison unit 6 via a connection unit 11. The measured values are compared by the comparison unit with the programmed target and limit values. In the event of deviations from the target and limit values, the control unit 5 automatically adjusts the measured variable to the target values by means of appropriate heating / cooling of the biological tissue. The device 1 further includes a pulse generation unit 14, which can emit electrical pulses via a connector unit 12 to yocardial stimulation electrodes. The stimulation voltages are typically between 0.5 and 10 V with a pulse duration of 0.5 to 10 ms and a stimulation frequency of 30 to 300 beats / min. The pulse generation unit enables myocardial anti-bradycardia stimulation (atrial or ventricular "pacing") to avoid hemodynamically important bradycardias during cooling of the myocardial tissue or heating of parasympathetic or cooling of sympathetic nerve fibers.

Preferred implantation sites of the

Thermoregulation electrodes are shown as examples in FIG. 2:

- Positioning of the fastening device 8 or of the elements of a thermoregulation device 1 which transmit the temperature change to the surroundings of the fastening location in or near the AV node 1, its atrial "inputs" 2a-c or the His bundle 3 (hatched area in FIG. 2). This probe can be used to reversibly cool / warm the AV node, thereby slowing down / accelerating the atrioventricular conduction. The extent of cooling / heating is determined by the ventricular rate, which is simultaneously via the device 1 with its

Temperature transmission element 2 or an additional probe is measured in the ventricle. If the chamber frequency rises above a previously programmed upper frequency limit, the local tissue temperature of the AV node / His bundle lowered, so that there is a reduced atrioventricular conduction and the chamber rate can be reduced. If the chamber frequency falls below a previously programmed limit value due to the cooling, the cooling is ended and the AV node tissue is warmed up again by the heat of the surrounding tissue or the convective warming by the surrounding blood, so that it accelerates again atrioventricular conduction and an increase in ventricular rate. Alternatively, the tissue can also be reheated by the probe itself.

An advantageous modification of the device 1 provides for local warming of the AV node when the temperature falls below a previously programmed lower ventricular heart rate, which leads to an acceleration of the atrioventricular conduction. The frequency limits can be dynamic and by measuring biological parameters such as physical activity, cardiac / thoracic impedance or e.g. QT times can be adjusted to the patient's needs. In a typical embodiment, several frequency zones are also provided, for which different steepnesses of the temperature adjustment can be programmed in order to avoid rapid heart rate jumps when the temperature changes.

Positioning of the fastening device 8 or of the elements of a thermoregulation device 1 which transmit the temperature change to the surroundings of the fastening location in or near the sinus node 4 for regulating the sinus node frequency. Positioning of the fastening device 8 or of the elements of a thermoregulation device 1 that transmit the temperature change to the surroundings of the fastening location in or near the right tawara leg 5 or left tawara leg 6 or the ventricular myocardium 7 for removing leg blocks by heating the tawara leg or for cooling an arrhythmogenic one ventricular substrate to prevent ventricular tachycardia.

Positioning of the fastening device 8 or of the elements of a thermoregulation device 1 which transmit the temperature change to the surroundings of the fastening location in or near the ventral (ventro-lateral) right atrial parasympathetic "fat pad" 8, which is the parasympathetic nerve fibers for the sinus node and the adjacent atrial Myocardium contains for reversible lowering / increasing the frequency of the sinus node by cooling / heating the right atrial "fat pad".

Positioning of the fastening device 8 or of the elements of a thermoregulation device 1 which transmit the temperature change to the surroundings of the fastening location in or near the inferior atrial parasympathetic "fat pad" (inferior vena cava - inferior atrial ganglion plexus) 9, which is the parasympathetic nerve fibers for the atrioventricular Node and the adjacent atrial myocardium contain for the reversible acceleration / deceleration of the conduction of the atrioventricular node by cooling / warming the inferior atrial "fat pad". For this purpose, the fastening device 8 or the Changes in temperature to the surroundings of the attachment site each transmitting element of the thermoregulation device 1 can also be implanted in the area of the proximal coronary sinus ostium 10.

If a stent is used for attachment and temperature transfer:

- Positioning of the fastening device 8 or of the elements of a thermoregulation device ^' 1 transmitting the temperature change to the surroundings of the fastening site in the vicinity of the parasympathetic nerves along the right 11 and left pulmonary artery 12, which are the parasympathetic nerve fibers for the sinus node, atrioventricular node and the right- and left atrial myocardium, for the reversible lowering / increasing of the frequency of the sinus node or for the reversible slowdown / acceleration of the conduction of the atrioventricular node as well as for the reversible shortening / lengthening of the atrial refractory period by heating / cooling the atrial "fat pad".

- Positioning of the fastening device 8 or the elements of a thermoregulation device 1 which transmit the temperature change to the surroundings of the fastening location in the vicinity of the parasympathetic nerves along the upper vena cava 13, which are the parasympathetic nerve fibers for the sinus node, atrioventricular node and the right and left atrial myocardium as well contain the ventricular myocardium, for the reversible lowering / increasing of the frequency of the sinus node or for the reversible slowdown / acceleration of the conduction atrioventricular nodes as well as reversible shortening / lengthening of the atrial refractory period or lengthening / shortening of the ventricular refractory period by heating / cooling parasympathetic nerves along the superior vena cava.

Positioning of the fastening device 8 or the elements of a thermoregulation device 1 which transmit the temperature change to the surroundings of the fastening location in or near the vagus nerve along the right and left jugular vein for the reversible frequency reduction / increase in the sinus node or for the reversible slowdown / acceleration of the conduction of the atrioventricular node as well as for reversible shortening / lengthening of the atrial refractory period or lengthening / shortening of the ventricular refractory period or for reducing / increasing gastrointestinal motility by cooling / warming the vagus nerve.

Positioning of the fastening device 8 or of the elements of a thermoregulation device 1 which transmit the temperature change to the surroundings of the fastening site in or near the sympathetic nerves which run along the right artery or subclavian artery 14 or the left artery or subclavian artery 15 for reversible frequency reduction / -Increasing the sinus node, to reversibly slow down / accelerate the conduction of the atrioventricular node, to reversibly lengthen / shorten the atrial refractory period or lengthen / shorten the ventricular refractory period and to reduce / increase the ventricular or atrial contractility by cooling / warming these sympathetic nerves.

- Positioning of the fastening device 8 or the elements of a thermoregulation device 1 which transmit the temperature change to the surroundings of the fastening location in the central coronary sinus to increase / decrease the ventricular contractility and

Shortening / lengthening the ventricular refractory period and increasing the sinus node frequency and improving the atrioventricular (AV node) conduction in bradycardia by heating / cooling sympathetic nerve fibers (including the ventrolateral nerve).

- Positioning of the fastening device 8 or of the elements of a thermoregulation device 1 transmitting the temperature change to the surroundings of the fastening location in the distal coronary sinus to increase / decrease the ventricular contractility and to shorten / lengthen the ventricular refractory period by cooling / heating parasympathetic nerve fibers (including craniomedial ventricular " pad ").

The implantation locations shown in the figures are described as examples. It is in the essence of the invention that a device 1 according to the invention with its temperature transmission element 2 can in principle be implanted at any intravascular / intracardial location for cooling / heating nerve or muscle tissue. A fixation of the fastening device 8 or the temperature change elements of the thermoregulation device 1 which transmit to the surroundings of the attachment site at all of the implantation sites mentioned can be made by known active fixation mechanisms such as screw or anchor electrodes.

In order to take into account the peculiarities of the implantation of the device in vessels, the invention provides, as explained, so-called "stent" or "coil electrodes", which are anchored in the vessel by active or passive expansion, and their outer surface as heat / Cold exchange surface serves.

The work steps used in the placement of the thermoregulation device 1 will now be explained in more detail with reference to FIGS. 3 to 8:

First, a catheter 100 is inserted into the vessel G. The catheter 100 has a through-channel 103 which extends from an insertion opening 101 to an outlet opening 102 arranged at the tip of the catheter 100 in the longitudinal direction of the catheter 100. In addition, the catheter 100 is equipped in a manner known per se with devices 104 which, for. B. by deriving monophase see action potentials to identify a destination.

The catheter 100 is inserted into the vessel G and advanced until its tip with the outlet opening 102 has reached the place of placement P. A guide device 105 designed as a guide wire is then inserted through the insertion opening 101 into the through-channel 103. The Guide device 105 can have a tip 106, which is assigned to the placement site P, in a helical shape (FIG. 8a), as a lancet with flexible barbs (FIG. 8b), as a lancet with an expandable metal arm (FIG. 8c), as an elongated lancet for penetration (FIG 8d) or as a lancet with a bent tip (Fig. 8e).

When the placement point P is reached, the guide device 105 is anchored with its tip 106 in the tissue present there. The catheter 100 is then pulled out of the vessel G. The guide device 105 remains in its anchored position.

After removal of the catheter 100, the temperature transmission element 108, which in this case is provided with a through-duct 107 in the form of a tube, is introduced into the vessel G in accordance with the thermoregulation device 1 and is therefore not shown here. The temperature transmission element 108 has at its tip assigned to the placement location P a temperature transmission section 109 designed as a Peltier element, which encloses a centrally arranged insertion opening. At its end arranged outside the body, an outlet opening 110 is formed on the temperature transmission element 108. The wire-shaped guide device is guided via the insertion opening through the through-channel 107 out of the outlet opening 110 (FIG. 6), so that the temperature transmission element 108 is safely guided on the guide device 105 on its way to the placement location P. In the exemplary embodiment shown in FIG. 7, the temperature transmission element 108 has a lateral outlet opening 111 arranged at a short distance from the insertion opening. In this example, the guide device 105 is not guided through the channel 107 over the entire length of the temperature transmission element 108, but runs only over a short length section in the channel 107. This can be advantageous if the vessel G is complex in shape and has tight curvatures during insertion of

Temperature transmission element 108 must be covered.

After the temperature transmission section 109 bears against the placement location P, the anchoring of the guide device 105 is released and the guide device 105 is removed from the body.

Claims

P A T E N T AN S P RÜ C H E

Device which can be permanently positioned with a fastening device, by means of which it can be permanently fixed in or on the heart of a living being at a fastening point, such as the atrioventricular node, sinus node, myocardial conduction system or autonomic nervous system of the human heart, and with a temperature influencing device for changing the temperature in an area of the heart restricted to the area surrounding the attachment site.

Apparatus according to claim 1, d a d u r c h g e k e n n z e i c h n e t that ß ß ß by means of the temperature influencing device, the temperature in the vicinity of the mounting location to 10 ° C to 35 ° C, in particular 29 ° C to 35 ° C, can be lowered.

Device according to one of the preceding claims, characterized in that the temperature can be raised to up to 41 ° C by means of the temperature influencing device.

4. Device according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t, that the temperature influencing device comprises a refrigeration unit (4).

5. Device according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t, d a ß the temperature influencing device is thermally connected to a temperature transfer element which is in thermal communication with the surroundings of the mounting location in a fully positioned device.

6. Device according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t, d a ß the temperature influencing device is in thermally conductive connection with the fastening device.

7. The device of claim 5 and 6, d a d u r c h g e k e n n z e i c h n e t, that the temperature transfer element is thermally insulated from the environment.

Device according to one of the preceding claims, characterized in that the temperature influencing device is formed by a Peltier element.

9. Device according to one of the preceding claims, d a d u r c h g e k e n e z e i c h n e t, d a ß it has a temperature transmission section which is in thermally conductive connection with the environment of the mounting location in the fully positioned device.

10. The device according to claim 9, d a d u r c h g e k e n n z e i c h n e t, that the temperature transmission section is formed by a tissue which changes its circumference as a result of a deformation force.

11. The apparatus of claim 10, d a d u r c h g e k e n n z e i c h n e t, that the temperature transfer section is formed by a stent.

12. The apparatus of claim 10, d a d u r c h g e k e n n z e i c h n e t, that the temperature transmission section is formed by a coil former.

13. The apparatus of claim 8 and one of claims 9 to 12, d a d u r c h g e k e n n z e i c h n e t, d a ß on the scope of

Temperature transmission section are arranged several Peltier elements.

14. Device according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t, d a ß it has an electrical conductor through which electrical impulses can be transmitted to the heart in the fully positioned device.

15. Device according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t, that the fastening device is formed by a screw element.

16. Device according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t, that the fastening device has at least one hook which can be anchored at the fastening location.

17. Device according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t, that the fastening device consists of an electrically conductive material.

18. Device according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t, d a ß the temperature transmission element has a through channel, through which a guide device can be guided.

19. Method for positioning a device designed according to one of the preceding claims, in a vessel of a living being, in which the following steps are carried out: - Inserting a catheter into the body to the place where the

Temperature transmission device is to be positioned, the catheter having a through-channel which leads from an insertion opening lying outside the body when the catheter is fully positioned to an outlet opening of the catheter arranged in the region of the placement site when the catheter is fully positioned,

Anchoring a guide device running through the passage channel of the catheter at the place of placement,

Removal of the catheter from the body while the guiding device remains in the body,

Inserting a temperature control element into the body, the temperature control element being guided through the guide device,

- Removing the guide device from the body.

20. The method according to claim 19, wherein the guide device is guided through a passage channel of the temperature transmission element.