A NEW NEUROMODULATOR STENT CONFIGURATION IN PERIRENAL AORTA FOR PERMENANT AND TEMPORARY USE IN HYPERTENSION AND

HYPOTENSION TREATMENT

Technical Field

The invention relates to a new neuromodulator stent configuration located in the perirenal aorta for permanent or temporary use for the treatment of hypertension and hypotension.

Background of the Invention Hypertension prevalence is increasing in Turkey and disease burden is heavy in many countries all over the world affecting one out of every three individuals. The number of hypertensive patients worldwide is estimated to be 1.5 billion in 2025.

Hypertension is the most important risk factor for early cardiovascular death, cerebrovascular disease, congestive heart failure, coronary artery disease, chronic renal failure and peripheral arterial disease. A significant number of patients with hypertension have resistant hypertension.

Surgical sympathectomy, cut-off and reanastomosis of the renal artery, destruction of the adventitia by local phenol administration, selective renal 6-hydroxy dopamine infusion, and renal sympathetic radio frequency ablation showed significant decreases in blood pressure but had many side effects.

Taking more than one medication every day for hypertension is quite difficult for patients. For this reason, alternative treatment methods are being studied.

Autonomic imbalance in hypertensive patients indicates the need to develop new strategies for autonomic modulation. Renal sympathetic nerve denervation, carotid baroreceptor activation therapies, vagus nerve stimulation and spinal cord stimulators are the treatments used in this field.

Autonomic control of the kidneys is mainly with sympathetic control. The central nervous system is innervated along the adventitial layer of the renal artery with afferent and efferent nerves. These nerve endings originate from sympathetic ganglia located along the aorta.

Activation of the renal efferent nerves leads to an increase in renin release, activation of the renin-angiotensin-aldosterone system, renal vasoconstriction, increased sodium and water retention. Renal afferent sympathetic nerves are activated after decreased renal perfusion, ischemia or renal parenchymal injury. As a result of this activation, the sympathetic region is activated in the brain and causes increased blood pressure and hypertension in the heart, blood vessels, kidneys, and increased efferent nerve stimulation. The parasympathetic system stimulates the heart through the vagal nerve, and the decrease in vagal activity causes increased heart rate.

In essential hypertension, there is a continuous activation of the afferent and efferent sympathetic nerves of the kidneys, which is one of the mechanisms of essential hypertension. Prolonged and exaggerated activation in renal afferent and efferent nerves may cause resistant hypertension and other complications. Resistant hypertension is defined as high blood pressure resistant to 3 or more drugs one of which is diuretic. The central role of sympathetic nerves in hypertension makes these nerves an important target for the treatment of hypertension.

Previously, surgical sympathectomy, renal artery cutting and reanastomosis, local phenol administration, adventitia damage, selective renal 6-hydroxy dopamine infusion, renal sympathetic radiofrequency ablation, and severe pressure decrease were observed, but orthostatic tachycardia, postural hypotension, erectile dysfunction, bladder and bowel problems side effects are observed.

Afferent and efferent sympathetic nerves are located in the adventitia of the renal artery, and their proximity to the inner lumen of the renal artery enables ablative energy to be given to these nerves by percutaneous catheter methods. The purpose of these therapies is to control the hypertrophy of the sympathetic nerves located 3-5 mm below the vessel lumen with the energy supplied from the vessel lumen. Energy can be transmitted by radiofrequency or ultrasound for damage to the renal sympathetic nerves. Radiofrequency principle-based catheter systems (Simplicity- Medtronic Inc., EnligHTN-St Jude Medical Inc., Vessix-Boston Scientific Inc., Oneshot-Covidien Inc.) are commercially used and operate with the principle of damage to the nerves by radiofrequency energy. Catheter systems that are ablated by ultrasonic energy (Paradise-ReCor Medical Inc., TIVUS-CardioSonic Ltd, Kona Surround Sound-Kona Medical Inc.) are used commercially. The pharmacologically ablating system (Bullfrog micro-infusion catheter system-Mercator MedSystems Inc.) is used commercially.

Arterial baroreceptors in the carotid sinus and aortic arch present afferent signals to the cardiothoracic and vasomotor centers that control the sympathetic tone of the heart and peripheral vessels in the medulla oblangata region of the brain. Increased blood pressure causes an increase in the signals from the baroreceptors to the brain stem after stretching in the aorta and carotid sinus. In response, the sympathetic stimulation to the heart and blood vessels decreases, the heart rate decreases, the pulse volume of the heart decreases, vasodilatation occurs and consequently the blood pressure decreases. In hypertension, desensitization occurs in baroreceptors and a higher threshold is formed for activation. External excitation of the carotid baroreflex leads to a decrease in heart rate, vasodilatation, and blood pressure reduction of the central nervous system. Commercial systems are used for carotid sinus stimulation (Rheos-CVRx, Minneapolis, MN, USA and Barostim neoTM -CVRx, Minneapolis, MN, USA).

The efficacy of selective renal denervation and carotid baroreceptor stimulation could not be demonstrated in the treatment of hypertension.

To date, studies have shown that brain stimulation techniques may have an acute effect on cardiovascular function, and that chronic periventricular-periacuaductal gray matter stimulation is highly effective on the cardiovascular system. The results of stimulation of these regions are in the form of observations obtained for other purposes, rather than for the purpose of treating hypotension or hypertension. The desired results can be obtained by neuromodulation of nerves in perirena and periaortik nerves at renal level instead of invasive methods such as deep brain stimulation in hypertension or hypotension.

Neurostimulation can be performed with passive microstimulators in micro dimension. The microstimulators can stimulate the nerves by taking the stimulus energy wirelessly and turning it into an impulse. Eliminating the cable connections between the microstimulator and the external electronic circuits increases the implantation options in biological systems and ensures the use of lifetime implants. Microsimulators do not contain active electronic circuits or contain very limited circuits and can be produced in millimeter sizes. The power for the microstimulators is usually mediated by the less absorbed radiofrequency waves in the tissue. The power transfer with the radiofrequency waves is ensured by the coaxial placement of the transmitter and receiver antennas and the inductive coupling. The frequency selection to be used is determined by the antenna size, penetration depth in the tissue and the required power. The frequency range of 3-30 GHz provides a good balance between antenna length (1-2 mm) and tissue penetration (1-10cm). The receiver antenna shape is possible in parallel to the length of the microstimulator or even in thin film antennas. The RF energy can be carried out by means of a transistor placed in the antenna.

Hypotension and accompanying shock are characterized by inadequate or inappropriately distributed tissue perfusion and circulatory failure characterized by cellular hypoxia in the whole organism. The purpose of hypotension and accompanying shock is to balance circulation to adjust the body's oxygen demand. Shock may occur with different mechanisms: hypovolemia and insufficiency of the right heart due to insufficient filling (eg serious bleeding), myocardial insufficiency due to myocardial dysfunction, increased peripheral resistance, distributive shock (sepsis or anaphylaxis). In the shock, the compensatory mechanisms are activated and the adrenergic autonomic nervous system is activated, venous constriction increases the blood returning to the heart, arterial vasoconstriction reduces blood going to unnecessary areas and increase in myocardial contractility is observed due to adrenergic stimulation. In the later stages of the shock, the renin-angiotensin- aldosterone system is introduced and water and salt retention in the kidney increases. Fluid replacement, dopamine, dobutamine, adrenaline, noradrenalin, intra aortic balloon pump, ECMO (extracorporeal membrane oxygenation) and left ventricular support systems can be used in the treatment of shock.

In case of deterioration of autonomic reflexes or reduction of intravascular fluid, severe blood pressure decreases can be observed. Orthostatic hypotension is defined as a blood pressure decrease of 20 mm in systolic blood pressure or 10 mmHg in diastolic blood pressure when tilt table test is performed. Orthostatic hypotension may cause severe cardiovascular morbidity and mortality in some cases. Falling in orthostatic hypotension can also cause accompanying injuries. Orthostatic hypotension can be seen as some of the side effects of neurological diseases or medication. In addition to pure autonomic failure, Parkinson's disease, multisystem atrophy, secondary autonomic dysfunction (diabetes mellitus, amyloidosis, spinal cord injury, dementia) and postprandial hypotension may cause orthostatic hypotension. In the treatment of orthostatic hypotension lower extremity compression, increased water and salt intake, isometric lower extremity exercises, squatting or maneuvering of the legs, fludrocortisone, midrinone and pyridostigmine can be used.

In the patent application No. US2013123880A1 in literature the subject matter is related that“ For some applications of the present invention, a subject suffering from congestive heart failure, diastolic heart failure, hypertension, and/or another disorder is identified. The subject is typically treated by implanting at least one electrode on the subject's vagus nerve at a vagal site and/or at an aortic site that is typically as described hereinbelow. Typically, a plurality of electrodes are implanted at the vagal site, and/or the aortic site. The subject is treated by driving a current into the electrode implantation site. The effects of driving the current into the implantation site typically include ventricular and aortic pressure reduction, an increase in aortic compliance, a decrease in sympathetic tone, a decrease in heart rate, and/or an increase in parasympathetic tone. These effects are typically advantageous in treating heart failure”

In the present application, it is basically described as implanting at least one electrode into the vagal nerve and implanting at least one electrode into the aorta and stimulating the vagus nerve.

In the patent application No. US2006116736 in literature the subject matter is related that “The present invention teaches a method and apparatus for physiological modulation, including neural and gastrointestinal modulation, for the purposes of treating several disorders, including obesity, depression, epilepsy, and diabetes. This includes chronically implanted neural and neuromuscular modulators, used to modulate the afferent neurons of the sympathetic nervous system to induce satiety. Furthermore, this includes neuromuscular stimulation of the stomach to effect baseline and intermittent smooth muscle contraction to increase gastric intraluminal pressure, which induces satiety, and stimulate sympathetic afferent fibers, including those in the sympathetic trunk, splanchnic nerves, and greater curvature of the stomach, to augment the perception of satiety.” In the aforementioned embodiment, neuromuscular stimulation is disclosed in order to increase the feeling of satiety in the treatment of obesity.

Due to the aforementioned disadvantages, a new neuromodulator stent configuration was required.

Disclosure of the Invention

From this aspect of the art, the object of the invention is to provide a new neuromodulator configuration structure that avoids the present disadvantages.

Another object of the invention is to provide a structure that can be inserted into the aorta at renal opening level angiographically without requiring surgery. Another object of the invention is to provide a neuromodulator configuration that does not cause permanent damage to the nerves.

Another object of the invention is to provide a wirelessly rechargeable structure from the outside.

Another object of the invention is to provide a structure in which patients can continue their treatment without making a lifetime change. Another object of the invention is to provide a structure that allows software and frequency changes to be made under skin or in the other part of the body to reprogram the software of the unit.

A further object of the invention is to provide a structure that includes an RF unit that can be implanted in the waistband or implanted under the skin in the abdomen.

A further object of the invention is to provide a structure that allows for the decrase of blood pressure with neuromodulation without ablation. A further object of the invention to provide an alternative treatment for taking antihypertensive medication every day, and in some cases to eliminate the need to use more than one drug.

Another object of the invention is to provide a structure that excites only the anterior region of the aortic stent, making neuromodulation more effective, and avoiding stimulation of other nerves in the posterior side of aorta and reducing side effects.

It is a further object of the invention to provide a bipolar electrode that comprises openings in the middle region that do not disrupt prevent renal blood flow from the aorta. Explanation of Figures

Figure 1 - A representative view of a conductive coated aortic neuromodulator stent configuration from the middle designed as a bipolar stimulator electrode in the form of the invention.

Figure 2- A representative view of the aortic neuromodulator stent configuration controlled by the invention, which is designed as a bipolar stimulator electrode, is controlled by means of conductive coated surface, stimulation and stimulation cables. Figure- 3 A representative view of the aortic neuromodulator stent configuration with microstimulators and placement of microstimulators around the orifices which allow normal renal artery blood flow from aorta.

Figure- 4 is a representative view of the retractable aortic neuromodulator stent configuration connected with retracting and stimulation cables, with the open renal orifices of the present invention.

Figure- 5 is a representative view of the structure of the bipolar aortic neuromodulator stent, which presents the anterior and posterior parts of the invention that are separate and only anterior face has stimulation function.

Figure- 6 is a representative view of the aortic neuromodulator stent configuration for temporary use in the form of a bipolar electrode in which the anterior and posterior parts of the invention are separate and only anterior surface has stimulation function Figure- 7 is a representative view of the implanted aortic stent implanted into the aorta with conductive coating on the middle of the insulated connection designed as a bipolar stimulator electrode.

Figure 8 is a representative view of the implanted retractable aortic neuromodulator stent configuration designed as a bipolar stimulator electrode isolated in the middle in the form of an implant

Figure 9 is a representative view of the invention implanted in the aorta of the bipolar permanent aortic neuromodulator stent configuration.

Figure 10 is a representative view of the rechargeable stimulator device of the bipolar aortic neuromodulator stent configuration of the invention and the charge, scheduler and treatment applicator console. Reference Numbers

A- Neuromodulator Stent Configuration

I . Blood Pressure Sensors

2. Insulation Connection

3. Electronic Circuit

4. Flat antenna

5. Coil antenna

6. Negative Pole of the Bipolar Electrode Stent

7. Positive Pole of the Bipolar Electrode Stent

8. Withdrawal, Warning and Stimulation Device

9. Microstimulator

10. Isolated part

I I . Conductive Coated Aortic Stent

12. Aorta

13. Renal artery

14. Kidney

15. Perirenal and Periaortic Nerves

16. Console

17. Stimulator Device

Detailed Description of the Invention

In this detailed description, the innovation is described with examples that will not have any limiting effect for better understanding of the subject matter.

The invention relates to a novel neuromodulator stent configuration (A) located in the perirenal aorta (1 ) for permanent or temporary use for the treatment of hypertension and hypotension characterized in that; comprises blood pressure sensor (1 ) located on said neuromodulator stent configuration which determines the value of the blood pressure and determines its value, a positive pole of the bipolar electrode stent (7), assisting in regulation by stimulating the upper part of said renal artery (13) forming the portion of said neuromodulator stent configuration (A) positioned as a positive electrode; a negative pole of the bipolar electrode stent (6), which assists in the regulation by stimulating the lower part of said renal artery (13) forming the portion of said neuromodulator stent configuration (A) positioned as a negative electrode, an isolation connection (2) formed between the positive pole of the bipolar electrode stent (7) and the negative pole of the bipolar electrode stent (6) and which functions to protect the blood flow of the renal arteries (13); microstimulator (9) that stimulates perirenal and periaortic nerves (15) with different algorithms and regulates blood pressure in cases of hypotension or hypertension.

Figure 1 illustrates a representative view of a conductive coated aortic neuromodulator stent configuration (A) designed as a bipolar stimulator electrode isolated in the middle and having orifices for allowing adequate blood flow to renal artery from aorta in the form of the invention.

Figure 2 illustrates a representative view of the retractable aortic neuromodulator stent configuration (A) with conductive coating, sensors and stimulation device (8), which has an insulation connection in the middle (2) allowing normal blood flow to renal arteries and is designed as a bipolar stimulator electrode in the form of a bipolar stimulator electrode. Figure- 3 illustrates a representative view of the aortic neuromodulator stent configuration (A) with microstimulators (9) and microstimulators placed around open orifices allowing normal blood flow to renal arteries.

Figure 4 illustrates a representative view of the retractable aortic neuromodulator stent configuration (A) with microstimulators (9) and microstimulators placed around open orifices allowing normal blood flow to renal arteries and connecting cable, withdrawal connections, sensors and stimulation device (8).

Figure 5 depicts a representative view of the bipolar aortic neuromodulator stent configuration (A), which gives the anterior and posterior portions of the invention, which are separate and only anterior surface is giving stimulation.

Figure 6 is a representative view of the aortic neuromodulator stent configuration (A) for temporary use in the form of a bipolar electrode in which the anterior and posterior parts of the invention are separate and only anterior surface is giving stimulus

Figure 7 illustrates a representative view of the conductive coated aortic stent (11 ) implanted into the aorta (12) over the middle of the insulating connection (2) designed in the form of a bipolar stimulator electrode of the invention.

Figure 8 depicts a representative view of the implanted aortic stent (11 ) with insulating connections in the middle (2), which is designed as a bipolar stimulator electrode.

Figure 9 illustrates a representative view of the implanted bipolar permanent aortic neuromodulator stent configuration (A) in the aorta (12). Figure 10 illustrates a representative view of the bipolar aortic neuromodulator stent configuration (A) of the invention and the rechargeable stimulator device (17) and the charging, scheduler and treatment applicator console (16).

The neuromodulator stent configuration (A) according to the invention consists of main parts that; blood pressure sensors (1 ), insulation connection (2), electronic circuit (3), flat antenna (4), coil antenna (5), negative pole of the bipolar electrode stent (6), positive pole of the bipolar electrode stent (7), withdrawal, sensor and stimulation device (8), microstimulator (9), isolated part (10), conductive coated aortic stent (11 ), aorta (12), renal artery (13), kidney (14), perirenal and periaortic nerves (15), console (16), stimulator device (17).

The invention is based on an external pulse generator with a rechargeable battery that can be placed outside the skin or under the skin, and microstimulators (9) on stent placed in aorta (12) by angiographic method at the level of both renal arteries (13) through the console (16), relates to a neuromodulator stent configuration (A) comprising a flat antenna (4) and a coil antenna (5).

The blood pressure sensors (1 ) on the conductive coated aortic stent (11 ), which are part of the system, detect blood pressure and said microstimulators (9) stimulate the perirenal and periaortic nerves (15) with different algorithms and regulate blood pressure in cases of hypotension or hypertension.

Said neuromodulator stent configuration (A) may also be used for temporary use in conjunction with withdrawal, sensor and stimulation device (8).

The percutaneous placed system in aorta (12) at the renal level of the system can be formed in three separate models. In the first version, the neuromodulator stent configuration (A) is formed as a two-part +/- stimulator electrode, the negative pole of the bipolar electrode stent (6) and the positive pole of the bipolar electrode stent (7).

The negative pole of the bipolar electrode stent (6) and the positive pole of the bipolar electrode stent (7) is conductor-coated to transmit the stimulus and acts as a + and - pole.

Instead of using separate electrodes on the neuromodulator stent configuration (A), the perirenal and periaortic nerves (15) going to the renal artery (13) are stimulated to regulate high or low blood pressure using the neuromodulator stent configuration itself (A) as electrodes.

In the second version, the renal artery (13) outlets of the conductive coated aortic stent (11 ) are left open and the electrodes that are to stimulate the perirenal and periaortic nerves (15) are placed around these openings around the right and left renal arteries (13).

In both versions, the flat antenna (4) and the coil antenna (5) structure and the circuits on it are the same.

In the third version, the neuromodulator stent configuration (A) is formed in four parts. The parts of the neuromodulator stent configuration (A) above and below the renal artery (13) are the negative pole of the bipolar electrode stent (6) and the positive pole of the bipolar electrode stent (7). The negative pole of the bipolar electrode stent (6) and the positive pole of the bipolar electrode stent (7) located in the positive and negative pole of the said neuromodulator stent configuration (A) are active only in the 180-degree portions of the perirenal and periaortic nerves (15) are stimulated around the anteriorly facing aorta (12) and the renal artery (13).

The insulating portion (10) of the said neuromodulator stent configuration (A) facing the posterior, 180 degrees of which is inactive.

In a preferred embodiment of said neuromodulator stent configuration (A), it is designed to be attached and retractable to the outside console (16) for temporary use in hypotension and hypertension. In temporarily used systems, the coil antenna (5) and the flat antenna (4) are not included, and all control and signal exchange is done by means of the cable formed in the retraction, withdrawal, sensor and stimulation device (8) connected to the console (16).

They are based on the principle of temporarily treating uncontrolled hypertension and hypotension and restoring the system after the need is removed. In temporary use systems, the neuromodulator stent configuration (A) is connected to the outside of the body by a cable and the blood pressure regulating console (16) is connected by cable. These two systems can be recovered with the parts seen in the figure after the patient's need is removed and taken out of the body by catheter method. In the permanent use of the system, the system, which is placed in the aorta (12) in 3 different designs according to need, is controlled wirelessly with an external microstimulator (9) placed under the skin and treats resistant hypertension or severe hypotension.

The neuromodulator stent configuration (A) that will stimulate the perirenal and periaortic nerves (15) is positioned as the positive pole of the bipolar electrode stent (7) and the negative pole of the bipolar electrode stent (6) in the form of + and - electrodes stimulating the perirenal and periaortik nerves superior and inferior to renal orifice (13). The isolation connection (2) between the negative pole of the said bipolar electrode stent (6) and the positive pole of the bipolar electrode stent (7) allows maintainance of free blood flow from aorta to renal arteries (13). The neuromodulator stent configuration (A), designed as the negative pole of the bipolar electrode stent (6) and the positive pole of the bipolar electrode stent (7), provides continuous stimulation during the dynamic movements of the aorta (12), while the perirenal and renal arteries (13) come from the aorta (12) and it provides 360 degree regular and effective stimulation of the surrounding nerves.

The signal sensor blood pressure sensor (1 ) and electronic circuits (3) on the neuromodulator stent configuration (A) are connected to the console (16) by cable. The blood pressure regulation is performed via the console (16) via the cable to which the neuromodulator stent configuration (A) is connected.

On the neuromodulator stent configuration (A), there are round holes at renal artery level (13) in order not to interrupt the blood supply. The microstimulators (9) are located circumferentially around the ostium of the renal artery (13) and receive the excitation signal and energy from the external pulse generator and console (16) and stimulate sympathetic nerves around the renal artery (13) which provides hypotensive and hypertensive response according to treatment algorithms.

Angiographically, a guiding catheter is inserted from the femoral artery under local anesthesia and the bipolar neuromodulator stent (11 ) is placed into the aorta (12) at the renal level over a 0.014-0.035 inch guidewire. The neuromodulator stent configuration (A) is of 3 types and is in separate models that are permanently implanted in figure 1 , 2 and 3. The neuromodulator stent configuration (A) of the neuromodulator stent configuration (A) in Figure 1 is designed as a positive pole of the bipolar electrode stent (7) and the negative pole of the bipolar electrode stent (6) and are isolated from each other which is designed as a positive and negative electrode.

In the neuromodulator stent configuration (A) in Figure 3, the parts of the stent corresponding to the orifices of the renal artery (13) are left open in order not to interrupt renal blood flow and the microstimulators (9) are placed 360 degrees around this opening.

In the neuromodulator stent configuration (A) in Figure 5, there is an isolated part (10) to isolate the upper and lower parts of the neuromodulator stent (A) and the anterior and posterior parts of the renal artery (13). The positive pole of the bipolar electrode stent located (7) on the anterior aspect of the neuromodulator stent configuration (A) and the negative pole of the bipolar electrode stent (6) give stimulation and the isolated posterior part (10) has no stimulation function.

The neuromodulator stent configuration (A) is also used in the models used for temporary use as indicated in Figure 2.4.6 and is connected to the outside console (16) by the cables for withdrawal, sensing and stimulation device (8).

The neuromodulator stent configuration (A) detects blood pressure with blood pressure sensors (1 ), blood pressure is determined and the sympatic nerves around the periaortic and renal artery (13) are stimulated by positive pole of the bipolar electrode stent (7), negative pole of the lower bipolar electrode stent (6) and they are stimulated by the microstimulator (9). The microstimulators (9) on the neuromodulator stent configuration (A) are stimulated by the stimulator device (17) that can be worn out of the body or implanted under the skin.

The microstimulators (9) on said neuromodulator stent configuration (A) may also be stimulated by retraction cables and console (16) located in the withdrawal, sensing and stimulation device (8).

The nerves in the suprarenal and periaortic area (15) are stimulated with the positive pole of the bipolar electrode stent (7) corresponding to the renal artery (13) of the neuromodulator stent configuration (A) shown in Figure 1. The perirenal and periaortic nerves (15) at the infrarenal level are stimulated by the negative pole of the bipolar electrode stent (6) on the lower side of the renal artery (13) of the neuromodulator stent configuration (A) in Figure 1. In the neuromodulator stent configuration (A) shown in Figure 3, the periaortic and perirenal nerves (15) are stimulated with microstimulators (9) located 360 degrees around the level of renal gap. In the neuromodulator stent configuration (A) shown in Figure 5, only the anterior surface parts of the perirenal and periaortic nerves (15) are stimulated with the positive pole of the bipolar electrode stent (7) and the negative pole of the bipolar electrode stent (6). The isolated portion (10) on the back side of the neuromodulator stent configuration (A) is isolated from the positive pole of the bipolar electrode stent (7) on the anterior side and the negative pole of the bipolar electrode stent (6) and does not stimulate the aorta (12).

The frequency and frequency of stimulation of said microstimulators (9) are adjusted by the console (16), which is positioned as pulse generator charging and programming console. The stimulation of the microstimulators (9) on the neuromodulator stent configuration (A) is achieved by means of the electronic circuit (3).

The external stimulator device (17), which can be worn outside of the body or implaned under the skin, transfers stimulus to the microstimulators (9) by means of a flat antenna (4) or a coil antenna (5). The neuromodulator stent configuration (A) for temporary use indicated in Figure 2.4.6 can be retrieved by arterial insertion, stimulation and retraction in the patient after treatment by using a neuromodulation method to treat hypotension or hypertension. It is determined by the console (16) or the stimulator device (17) how the neuromodulator stent configuration (A) is stimulated in hypotension or hypertension treatment.