WO2002058785A1

WO2002058785A1 - Vascular sleeve for intravascular nerve stimulation and liquid infusion

Info

Publication number: WO2002058785A1
Application number: PCT/EP2002/000755
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: DE10103288A1; EP1353724A1

Abstract

The invention relates to a device which enables percutaneous introduction in the vascular system with the possibility of a continuous liquid infusion and transvascular electric or electromagnetic nerve stimulation. The aim of the invention is to produce a vascular sleeve comprising a lumen section through which liquid can flow and which can be introduced into a vein in the body of a living human being, lumen section being made of a flexible plastic material; a filler section which is arranged on the outside of the body when the lumen section is introduced into the vein and which is fluidically connected to the lumen section, enabling liquid or medicaments to be applied and /or blood to be removed; an electrode which is arranged next to the lumen section for stimulating a nerve close to the vein.

Description

Vascular sheath for intravascular nerve stimulation and

fluid infusion

The invention relates to a vascular lock that can be introduced into arterial or venous vessels and through which fluids are infused and transvascular nerve fibers can be stimulated electrically or electromagnetically.

The technical and medical background on which the invention is based can be summarized as follows:

A) Undesirable sinus tachycardia or tachycardia

Atrial fibrillation is a significant clinical problem, particularly in patients with limited ventricular punk force. Tachycardia reduces the diastolic filling time of the left ventricle and consecutively reduces the cardiac output. The heart muscle is mainly supplied diastolic with oxygen through the coronary arteries. In the context of tachycardia, the diastole time is shortened, and thus the effective oxygenation of the heart muscle while increasing the myocardial oxygen demand through the rapid ventricular contraction. Unwanted sinus tachycardia or tachycardial atrial fibrillation often occur during the course of intensive care treatment as well - £ _. ***

in acute cardiac ischemic syndromes or hyperthyroidism. In the context of intensive care treatments, intravenous catecholamine therapy is often necessary in the treatment of acute heart failure and shock [1-3]. However, the increase in cardiac output and arterial blood pressure occurs at the expense of increased myocardial oxygen consumption, which is partly due to the undesirable positive chronotropic and dromotropic effects of the catecholamines [1,3]. In addition, undesirable sinus tachycardia / supraventricular tachycardia or atrial fibrillation with catecholamine therapy in some cases prevents the maximum usable dose of catecholamine in intensive care patients. Supraventricular tachycardia in the context of acute, cardiac ischemia is also a therapeutic challenge in patients with limited ventricular pump function. Conventionally used drugs for the treatment of such supraventricular tachycardia are digitalis glycosides, beta-receptor blockers and calcium channel blockers. 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, in doses that lower the heart rate, these substances have an extremely negative inotropic effect, which can lead to a further weakening of the heart's pumping capacity. Sudden cardiac death is in the

Statistics on causes of death come first and are responsible for approx. 50% of all cardiac deaths [4]. Long-term ECG recordings in people who died of sudden cardiac death have shown that in the vast majority of cases ventricular tachycardia, which often degenerated into ventricular fibrillation, was present in these patients [5].

It is known that structural myocardial changes due to ischemia and infarcts, cardiomyopathies or ventricular hypertrophy form an arrhythmogenic substrate, on the basis of which various triggers can trigger ventricular arrhythmias [6-9]. The sympathetic, autonomous nervous system plays a key role as a trigger mechanism in the development of ventricular arrhythmias [10-14]. In contrast, an increased parasympathetic tone protects against ventricular arrhythmias [15-19].

Anti-adrenergic interventions such as a beta-receptor blocker therapy can significantly reduce the risk of sudden cardiac death, especially in post-infarct patients [20-22].

The occurrence of ventricular arrhythmias cannot only be reduced by anti-adrenergic interventions. An increase in the parasympathetic, autonomic nerve tone can successfully reduce the incidence of ventricular rhythm disturbances in the animal model [15,16,18,23,24]. C) Chronic direct electrical stimulation of the vagus nerve with indwelling electrodes that are attached outside the vessels to the cervical vagus nerve or carotid sinus nerve is also described. In this way, angina pectoris complaints with coronary heart disease and the frequency of seizures with cerebral convulsions can be reduced [33,34].

It could be shown that parasympathetic nerves, which pull to the heart along the large vessels, can be electrically stimulated with electrode catheters transvascularly in the superior vena cava, the inferior vena cava, the coronary artery sinus or the pulmonary arteries [24-32]. In this way, a reduction in the sinus node frequency or the atrioventricular (AV) conduction can be achieved, which is easily controllable and reversible depending on the preselected stimulation voltage and frequency. In particular, the parasympathetic stimulation does not lead to a relevant reduction in the pumping force of the heart chambers, which is a significant advantage in patients with heart failure and tachycardia.

The central problem with such a transvascular stimulation of autonomic cardiac nerves is the stable placement of a stimulation electrode (stimulation catheter), which is narrow in relation to the inner lumen of the vessel, on the generally very smooth inner wall of the vessel. In addition, there should be no clinically relevant flow reduction in the vessel through a stimulation catheter. Finally, blood clots on the stimulation catheter in the central vascular system should be avoided. The catheter should also be quick and as possible be placed in an effective stimulation site in the vessel without X-ray fluoroscopy.

A multi-electrode catheter has been proposed in which stimulation electrodes are attached along an electrode basket that can be expanded by a pulling mechanism. The unfolded basket firmly anchors the catheter in the vessel.

All previous methods for temporary transvascular electrical stimulation of nerves are based on the introduction of a specific stimulation catheter into the vascular system through a vascular lock. The disadvantage here is that two foreign bodies have to be introduced into the vascular system as a potential source of infection, the vascular lock itself and a stimulation catheter. In addition, a stimulation catheter moves the inner lumen of the sluice, so that liquid infusions cannot be administered or can only be administered with a delay using increased infusion pressures. The introduction of an intravascular stimulation catheter also increases the risk of clot formation on the catheter. In contrast, when using conventional vascular locks, no anticoagulation is usually necessary.

Proceeding from this, the object of the invention is to create a device which combines the possibility of percutaneous introduction into the vascular system with the possibility of continuous fluid infusion and transvascular electrical or electromagnetic nerve stimulation. This object is achieved according to the invention by a vascular lock which is filled with a liquid flowable, into a vessel of the body of a living being, made of a flexible plastic material, with a lumen section inserted into the vessel outside the body, which is in flow communication with the lumen section, through which liquid or medication can be applied and / or blood can be drawn and is equipped with an electrode arranged on the lumen section for stimulating a nerve abutting the vessel.

A stimulation / vascular lock according to the invention, preferably made of a plastic material, has a central inner lumen which, after vascular puncture, is introduced into the vessel, preferably the right or left internal vena jugularis, by means of a Seldinger hollow needle via a guide wire inserted over the Seldinger hollow needle can.

The central lumen is designed so that it can be used for the application of liquid or medication and for blood collection. For this purpose, the lumen section is preferably coupled to a side arm serving as a filling section, on which the filling opening required for filling liquid and medication or for taking blood is formed.

On the outside of the vascular lock there is at least one, preferably two or more metallic, conductive electrodes which are electrically insulated from one another in the event that a plurality of electrodes are present. A nerve adjacent to the vessel, typically the cervical vagus nerve along the internal jugular vein, can be stimulated unipolarly, bipolarly or multipolarly electrically or electromagnetically transvascularly via these stimulation poles.

As mentioned, one to two or a plurality of such stimulation electrodes can be attached to the vascular lock. They can be aligned axially or orthogonally to the vessel / lock axis. The length and width and the distance of each

Stimulation electrodes depend on the diameter, length and curvature of the blood vessel into which the vascular lock is to be inserted. The dimensions of the individual stimulation electrodes of an individual stimulation / vascular lock can vary, the stimulation area of an individual electrode should preferably be 10 mm ² -30 mm ² . Depending on the application, however, it may also be sufficient if the stimulation areas have a size of 0.5 mm ² . It is also conceivable to design the electrodes so that they completely occupy the available outer surface of the vascular lock at least in the area in which the lumen section is guided into the respective vessel.

The electrode spacing is preferably in the range of 0.1 cm and 10 cm, in practice it is typically 5 mm. The electrode shape can be rectangular, ellipsoidal, arched or (semi) annular.

A preferred embodiment of the stimulation / vascular lock sees the use of a Helmholtz coil on the vascular lock, via which an alternating magnetic field can be applied for nerve stimulation.

To prevent clot formation (thrombus formation) along the vascular lock, parts or all of the lock can be coated with a clot-inhibiting substance (e.g. heparin).

In order to allow the vascular sheath to come into as close a contact as possible with the vascular wall and the nerve fibers adjacent to the vascular wall, the diameter of the sheath can be adapted to the inside diameter of the vessel in which the nerve stimulation is to be carried out. Typical sluice diameters in the area of the lumen section are 8-10 French, but in principle any diameter between 3 French and 20 French (approx. 6 mm) can be suitable for stimulation.

Other alternative lock designs can have a specifically pre-bent shape (primary shape) along their longitudinal direction. For example, S-shaped locks are provided, the convexity of which lies against the inside of the vessel wall, or spiral-shaped or other types of locks. To insert the lumen section, the sluice is first passed over a straight plastic dilator, which completely fills the inner lumen of the vascular sluice. After the dilator and the vascular lock have been introduced into the vessel via a guide wire, the guide wire and the dilator are removed from the vessel, so that the vascular lock assumes the pre-embossed primary shape due to its inherent elasticity. This leads to the passive attachment of the vascular lock with the external stimulation electrodes to the vascular wall. The aim of all such primary forms is to achieve the best possible and stable wall contact after placing the lock in the vessel and at the same time not significantly reducing the blood flow in these vessels.

It is also conceivable to actively bend (deflect) the vessel lock according to the invention itself in order to achieve better wall contact via a pulling mechanism integrated in the lock wall. Here, the curve dimension of the diffraction or the part of the lock and the length of the lock section that is bent can vary. A further modification of the vascular lock provides a balloon which is preferably attached eccentrically to the vascular lock and which can be inflated with air or liquid via a feed line. Inflation of the balloon presses and stabilizes the opposite side of the vascular lock with the electrodes on the vascular wall. Alternatively or in addition, the balloon itself can have metal stimulation electrodes, via which electrical / magnetic stimulation of the nerves adjacent to the vessel can take place after the balloon has been insufflated.

A further embodiment provides a metal electrode arm which can be expanded by a pulling mechanism and which, as part of the vascular lock, rests on the outside or is integrated in its wall. One or more metallic individual electrodes, insulated from one another, are attached to this electrode arm. By means of a pull thread or wire connected to the lock, the electrode arm can be expanded so that it takes on a semicircular shape, the convex side of this semicircle being away from the vascular lock The inner wall of the vessel is directed and lies closely against the transvascular stimulation.

Basically, every modification of the vascular lock after insertion into the respective vessel is placed by pushing or pulling back as well as by rotation at an effective intravascular nerve stimulation site. In order to achieve rotational stability of the vascular lock and the electrodes attached to it after successful placement, the lock is fixed to the skin by an adhesive strip or a seam.

The stimulation electrodes of the vascular lock are electrically connected via suitable connecting sockets to the part of the vascular lock located outside the body outside the body. An adapter cable can be attached to these connecting sockets, which connects the electrodes of the vascular lock with an external stimulation unit. The Sti ulationseinheit consists of a pulse generation unit and a detection unit.

The pulse generation unit is, for example, a voltage / magnetic field generator which is able to generate electrical / magnetic stimulation pulses. The pulse duration can be between 0 and 20 ms (typically 0.05 to 5 ms) and the stimulation frequency between 0 and 1000 Hz (typically 2-100 Hz). The pulse shape can be mono-, bi-, or triphasic. The stimulation voltage can be between 1 and 100 V. Alternatively, the stimulation is carried out by alternating magnetic fields. A detection unit, which is connected to one or more measuring probes, can be used to detect biological measured variables, such as heart rate, blood pressure, oxygen partial pressure, repolarization times and changes in the regression of the heart. A starting unit which responds to the detection variables puts the pulse generating unit into operation as soon as the measured variable falls below / exceeds a certain limit value.

The nature of the stimulation / vascular lock described allows different applications.

- Transvascular stimulation of vagus nerve fibers in the internal jugular vein (vena cava) to reduce the frequency of supraventricular tachycardia. The vascular / stimulation sheath can be inserted in the right or left internal jugular vein or the superior vena cava. The internal jugular vein lies together with the internal carotid artery and the vagus nerve in a vascular / nerve sheath of the neck covered with connective tissue. Nerve stimulation in the right internal jugular vein primarily leads to a decrease in the sinus node frequency and an extension of the atrioventricular conduction. In addition, the ventricular refractory period is lengthened and the atrial refractory period is shortened. When stimulating the left jugular vein, the focus is on the extension of the atrioventricular conduction. Here, too, however, the sinus node rate can be slowed down and, above all, the ventricular refractory period can be lengthened and the atrial refractory period shortened. A stimulation more parasympathetic Nerve fibers in the jugular vein via the combined vascular / stimulation sheath are therefore suitable for lowering the heart rate in supraventricular tachycardia, especially in patients with reduced left ventricular pumping function and / or arterial hypotension. In the case of sinus tachycardia, the right vagus nerve is preferably stimulated, while in the case of supraventricular tachycardia of other origin and in the case of tachycardia atrial fibrillation, the left vagal nerve is preferably stimulated. For both indications, depending on the ability of a jugular vein to puncture, the respective contralateral vagus nerve can be stimulated.

Transvascular stimulation of vagus nerve fibers in the jugular vein (superior vena cava) for the therapy and prevention of ventricular arrhythmias. The vascular / stimulation sheath can be inserted in the right or left internal jugular vein or the superior vena cava. The right-sided or left-sided vagus nerve stimulation serves to lengthen and homogenize the ventricular refractory period and thus to terminate and prevent ventricular arrhythmias.

Transvascular stimulation of vagus nerve fibers (or carotid sinus nerves) in the internal jugular vein or vena cava to improve the

Coronary blood flow / reduction of agina pectoris and to improve intestinal and renal blood flow / reduction of angina abdominalis in the context of ischemic syndromes. The vascular / stimulation sheath can be inserted in the right or left internal jugular vein or superior vena cava.

Transvascular stimulation of vagus nerve fibers in the internal jugular vein (vena cava) to promote intestinal or bladder motility to eliminate a (postoperative) paralytic intestinal ileus or bladder atony. The vascular / stimulation sheath can be inserted in the right or left internal jugular vein or the superior or inferior vena cava. For stimulation in the inferior vena cava, a stimulation / vascular lock can be demonstrated via a jugular vein or a femoral vein. Any bradycardias that may occur are remedied by transvenous application of a temporary supraventricular or ventricular pacemaker.

In the applications mentioned, the production of gastric acid should be completely inhibited by medication (such as with proton pump inhibitors) during vagus nerve stimulation, since it is below

Vagus nerve stimulation can lead to an increased release of acetylcholine-dependent gastric acid.

Transvascular stimulation of afferent vagus nerve fibers in the internal jugular vein to end cerebral seizures or to reduce the frequency of seizures in epileptics. The subliminal left-sided vagus nerve stimulation is particularly suitable for this. The vascular / stimulation sheath can be inserted in the left (right) internal jugular vein or in the superior vena cava. Transvascular stimulation of sympathetic (parasympathetic) nerve fibers along the right and left vein / subclavian artery. A sympathetic nerve loop that leads around the subclavian artery can be electrically stimulated by a vascular / stimulation sheath, which is introduced into the subclavian artery by a transcutaneous puncture. This increases the sinus heart rate, accelerates the atrioventricular conduction and increases the atrial and ventricular pumping force. Such effects are therapeutically desirable in patients with arterial hypotension, reduced left ventricular pump function and with bradycardia. An alternative embodiment for stimulating the sympathetic subclavian artery consists of an approx. 100 to 200 cm long pre-bent sluice, the tip of which is placed with nerve stimulation electrodes on the outside of the sluice in the left (right) subclavian artery opposite the subclavian artery. For this purpose, the sheath is inserted through a femoral artery. In the course of the stimulation sheath, at the level of the ascending thoracic aorta, there is an aortic balloon counter-pulsation unit, as is already used conventionally to stabilize blood pressure in patients with severe heart failure. The combination of selective cardiac nerve stimulation in the subclavian artery (with an increase in ventricular contraction force) and aortic counterpulsation improves the patient's hemodynamic situation in the long term. The main advantage of nerve stimulation in the subclavian artery over a conventional medicinal increase in blood pressure / cardiac pumping power by means of infusible catecholamines is that selective increase in cardiac sympathetic tone while avoiding intestinal, renal or peripheral vasoconstruction, which can conventionally contribute to so-called multi-organ failure.

Transvascular stimulation of parasympathetic nerves innervating the atrioventricular node by electrical stimulation using a long vascular / stimulation sheath, the tip of which is placed in the proximal coronary vein sinus. In this way, a selective negative dromotropic effect (which slows down the atrioventricular conduction) can be achieved, which is therapeutically desirable in the therapy of supraventricular tachycardia. In order to prevent atrial depolarization by the nerve stimuli, the nerve stimuli are delivered coupled in the atrial refractory period. The perception of atrial depolarization is e.g. due to a pair of electrodes on the outside of the vascular lock.

Transvascular stimulation of parasympathetic nerves that innervate the heart chambers by electrical stimulation using a long vascular / stimulation sheath, the tip of which is located in the distal coronary vein sinus, e.g. is placed in the area of the craniomedial ventricular ganglion plexus. This can have a protective effect against ventricular rhythm disturbances and circulatory disorders.

Transvascular stimulation of sympathetic nerves that innervate the ventricles, atria, sinus node and AV node by electrical stimulation using a long vascular / stimulation sheath, the tip of which is placed in the coronary vein sinus, for example in the area of the ventrolateral nerve. This can increase the atrial / ventricular pumping force, the sinus rate and the atrioventricular electrical conduction.

The invention is described in more detail below on the basis of preferred exemplary embodiments in conjunction with the drawing. Show:

1 shows a first embodiment of a vascular /

Stimulation lock, which is designed as a straight lock and which is connected to an external control unit

2 shows an embodiment of a vascular /

Stimulation lock, which is designed as a pre-bent lock,

3a shows a spiral embodiment of a vascular / stimulation sheath,

3b shows a convex embodiment of a vascular / stimulation sheath,

4 shows an embodiment of a vascular /

Stimulation sheath, which is designed as a pre-bent sheath for stimulation in the proximal, middle or distal coronary vein sinus, 5 shows an embodiment with several Helmholtz coils for magnetic nerve stimulation

6a, 6b an embodiment of a vascular /

Stimulation sheath, which has an eccentric, insufflatable balloon,

7 shows an embodiment of a vascular /

Stimulation lock with an externally integrated reversibly expandable metal electrode

8 embodiment of a vascular /

Stimulation sheath, which is designed as a pre-curved sheath for stimulating the Ansa subclavia and which has a balloon for aortic counter-pulsation in its course

9 embodiment of a vascular /

Stimulation lock, in which an additional, reversibly deployable balloon attached in the course of the lock is arranged for the temporary stabilization of the electrode position during patient transfers.

In the embodiment shown in FIG. 1, the stimulation / vascular lock A according to the invention comprises a tubular lumen section 1 through which liquid can flow, on the outside of which a plurality of mutually insulated metal stimulation poles 2 are attached. The stimulation poles are connected by electrical lines 3 to the connection sockets 4 on the lock head 5. Be an adapter cable 6 the connection sockets 4 are electrically connected to a stimulation unit 7. The stimulation unit 7 consists of a detection unit 8 for recording biological measured variables and a pulse generation unit 9.

Further features of the embodiment shown in FIG. 1 are a central inner lumen 10 of the vascular lock A present in the tubular lumen section 1, via which a guide wire and a plastic dilator for placing the lock can be inserted using Seidinger technology. The inner lumen 10 also serves to receive catheters for electrical cardiac stimulation, cardioversion / defibrillation, for monitoring hemodynamics (e.g. pulmonary irrigation catheters) or for angiography. The central inner lumen 10 closes with a valve 11 on the lock head 5. The central inner lumen 10 is also continuously connected via a lumen-containing, flexible side arm 12, via which liquids / medications can be applied. In order to ensure rotational stability of the vascular / stimulation sheath, the embodiment shown has a fixation band 13 and a suture eyelet 14, with which the sheath can be attached to the patient's skin. The fixation band 13 can be attached to the patient either by adhesive mechanisms or by reversible pressure / Velcro fasteners. The fixation band can be connected to the lock permanently or temporarily by means of connector plugs 15.

In the embodiment according to FIG. 2, in contrast to the embodiment according to FIG. 1, the vascular lock B is plastically deformable. From the picture it can be seen that the lumen section la assumes a curved primary shape 16 without a stiffening plastic dilator inserted into the central inner lumen, so that the stimulation electrodes 2 are pressed against the vessel wall 17. The curved primary shape also enables a relatively stable anchoring of the sluice in the vessel G. The dashed illustration part 18 indicates the straight sluice shape that the lumen section la assumes when the sluice B is reversibly stretched by introducing a plastic dilator into the vessel G.

FIGS. 3a and 3b show two further exemplary embodiments of a curved vascular / stimulation sheath. FIG. 3A shows a vascular lock C, which has a spiral pre-bent elastic lumen section 1b, while FIG. 3B shows a vascular lock D with a convexly bent lumen section 1c. Each of these or, depending on the stimulated vessel, differently pre-bent lock forms ensures that the stimulation electrodes 2 attached to the outside of the lock are pressed tightly against the inside wall of the vessel. The curved primary forms also serve to stabilize the lock in the vessel.

4 shows a vascular lock E with a pre-bent lumen section ld for the stimulation in the proximal coronary vein sinus 19 to extend the atrioventricular conduction by parasympathetic nerve stimulation.

FIG. 5 shows an embodiment of a vascular / stimulation lock F with a lumen section le a plurality of Helmholtz coils 20, which are arranged as electrodes for magnetic stimulation along the axis of the lumen section le.

In the variant according to FIG. 6A, an eccentric, insufflatable balloon is arranged along the lumen section lf of the vascular lock H. The balloon 21 is connected to the syringe 23 via a hose 22. 6B shows how through

Insufflation / instillation of air / liquid into the balloon 21, the lumen section 1f is bent and pressed against the inner wall of the vessel G with the external stimulation electrodes 2.

7 shows an exemplary embodiment of a stimulation / vascular lock I in which stimulation electrodes 24 and 25 are arranged on an expandable electrode arm 26 on the outside on the lumen section Ig. The electrode arm 26 is reversibly deployable via an internal pull line 27. In its unfolded, convex shape 28a, the

Individual electrodes 24 and 25 on the electrode arm 26 pressed against the inside of the vessel wall. Not unfolded

28b (dashed line) the electrode arm 26 lies closely against the vascular lock Ig or is sunk in the wall of the vascular lock Ig. The train line 27 becomes a handle in a stiffened sheathing line 29

30 performed in which an adjustable mechanical tension on which the train line can be applied and in which the individual electrode extensions 31 are connected to connector sockets 32.

Fig. 8 shows an embodiment in which stimulation electrodes 2 on the outside of the distal End of a 100-200 cm long lumen section lh of a vascular lock J are arranged. The lumen section lh is inserted into the femoral artery and the distal end is placed in the subclavian artery under X-ray fluoroscopy / transesophageal echocardiography in such a way that the stimulation electrodes 2 lie opposite the sympathetic (parasympathetic) nerves running along the subclavian artery. In the middle part of the vascular lock, a counter pulsation balloon 33 is arranged, which is connected via a gas pressure line 34 to a screw opening 35 which is attached to the lock head and which can be connected to a conventional counter pulsation system. The geometry of the lock is such that a simultaneous sympathetic (parasympathetic) nerve stimulation to increase the myocardial pumping force via the electrodes 2 as well as an aortic counterpulsation for augmenting the coronary and cerebral blood flow / pressure can be carried out.

The embodiment according to FIG. 9 is a vascular / stimulation lock K with a lumen section li, in which a balloon 36 which is reversibly expandable with air or liquid is additionally arranged in the course of the lumen section li and which has a lumen-containing supply line 37 with a Syringe 38 is connected. The relative position of the balloon 36 in the course of the vascular lock can vary (eg position 38) and depends, among other things, on the vessel in which nerve stimulation is to take place. To avoid dislocation of the vascular / stimulation tube from an effective intravascular nerve stimulation site when patients are being repositioned, balloon 36 or 38 is positioned eccentrically or concentrically around the patient Lumen section Li is arranged around, insufflated for several seconds or a few minutes, so that the vascular / stimulation sheath remains in place in the vessel. By simultaneously fixing the vascular lock head 5 with the fixation band 13 and 15, further immobilization of the vascular / stimulation lock is ensured.

The lock / electrode shapes shown in the figures are described as examples. It is in the essence of the invention that any lock and / or electrode shape suitable for the purpose of simultaneous fluid infusion / nerve stimulation can be used. In particular, each electrode design described can be used for each of the lock shapes shown or described. For example, it is provided that the electrodes 2 in FIG. 8 can alternatively have the embodiment 20, 24 or 25 or can be provided with a balloon 21. An immobilization balloon 36 as shown in FIG. 9 is also provided as a modification of each of the lock designs described.

literature

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Claims

PATE NTAN SPEECH

1. vascular lock,

- With a liquid that can be flowed through, into a vessel (G) of the body of a living being, from a flexible one

Plastic material manufactured lumen section (la-lh),

- With a lumen section (la-lh) inserted into the vessel (G) arranged outside the body, with the lumen section (la-lh) in flow connection filling section (12) via which liquid or medication can be applied and / or blood can be taken , and

- With an electrode (2) arranged on the lumen section (la-lh) for stimulating a nerve adjacent to the vessel (G).

2. Vascular lock 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 there are at least two electrodes (2) for stimulating the nerve.

3. Vascular lock according to one of the preceding claims, characterized in that the electrodes (2) are arranged along the lumen section (la-lh).

4. Vascular lock according to one of the preceding claims, characterized in that the stimulation surface of a single electrode (2) is 0.5 mm ² - 30 mm ^{2 in} each case.

5. Vascular lock according to one of claims 1 to 3, characterized in that the stimulation surface of the electrode (2) is 0.5 mm ^{2 in} each case.

6. Vascular lock according to one of claims 1 to 3, since the electrodes (2) completely cover the outer surface of the lumen section (la-lh) at least in the area over which the lumen section

(la-lh) is introduced into the vessel (G).

7. Vascular lock according to one of claims 2 to 6, d a d u r c h g e k e n n z e i c h n e t, that the distance between the electrodes (2) is in the range of 0.1 cm and 10 cm, in particular 5 mm.

8. Vascular lock according to one of the preceding claims, characterized in that the ß Electrode shape is rectangular, ellipsoidal, arched or (semi) annular.

9. Vascular lock 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 electrode

(2) is coupled to or formed by a Helmholtz coil (20) and d a ß the Helmholtz coil (20) generates an alternating magnetic field for stimulating the nerve.

10. Vascular lock 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 diameter of the lumen section (la-lh) is 3 to 20 French, in particular 8 to 10 French.

11. Vascular lock 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 lumen section (la-lh) has a curved shape in the longitudinal direction.

12. Vascular lock according to one of the preceding claims, characterized in that ß on the lumen section (la-lh) a balloon (21,33,36,38) is arranged, the volume of which can be changed by filling with a fluid, such as air or liquid ,

13. Vascular lock according to claim 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 the balloon

(21,33,36,38) carries at least one electrode on its outside coming into contact with the vessel (G).

14. Vascular lock according to one of the preceding claims, that an expandable metal electrode arm (26) is arranged on the lumen section (la-lh).

15. Vascular lock according to claim 14, where one or more metallic, mutually insulated individual electrodes are attached to the electrode arm (26).

16. Vascular lock, because of which the lock itself can be actively bent via a pull mechanism integrated in the lock wall to achieve better wall contact.

17. Vascular lock according to one of claims 14 to 16, characterized in that the electrode arm (26) is expandable by means of a pulling thread guided through the lumen section (la-lh).

18. Vascular lock according to one of the preceding claims, that a adhesive surface is formed in the region of the filling section (12), which can be attached to the skin of the living being.

19. Vascular lock 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 lumen section (la-lh) is connected to an adapter section (5) which is arranged outside the body when the lumen section (la) is inserted into the vessel (G).

20. Device for stimulating the heart of a living being, with a vascular lock (AF, HK) designed according to one of claims 1 to 19 and a pulse generating unit (9) for generating electrical / magnetic stimulation pulses which are connected to the vascular lock (AF, HK) existing electrode (2) is connected.

21. The apparatus according to claim 20, characterized in that the duration of the pulses generated by the pulse generating device (9) is between 0 and 20 ms, 0.05 to 5 ms.

22. Device according to one of claims 20 or 21, d a d u r c h g e k e n n z e i c h n e t, that the stimulation frequency is between> 0 to 1000 Hz, in particular 2 to 100 Hz.

23. Device according to one of claims 20 to 22, d a d u r c h g e k e n n z e i c h n e t, that the pulse shape is mono-, bi-, or triphasic.

24. Device according to one of claims 20 to 23, d a d u r c h g e k e n n z e i c h n e t, that the stimulation voltage is between 1 and 100 V.

25. The apparatus according to claim 20, characterized in that ß the pulse generating unit (9) is coupled to a detection unit (8) which detects biological measured variables of the treated living being and emits a signal for generating pulses as soon as the measured variable takes into account a tolerance range permissible measuring range.