HYPERTENSION TREATMENT

Technical Field

The invention relates to blood pressure sensor and regulator aortic stent embodiment for use in the treatment of hypertension.

In particular, the invention relates to an aortic stent construction with microstimulators, blood pressure sensors and antennas placed on the aorta without surgery by interventional or hybrid methods to include both renal arteries location.

The Basis of the Invention

The prevalence of hypertension is increasing and the disease burden is high, and is a major problem affecting one out of every three individuals together with Turkey in many countries all over the world. It is estimated that the number of hypertensive patients worldwide will 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 proportion of patients with hypertension have refractory hypertension.

Previously, surgical sympathectomy, renal artery occlusion and reanastomosis, adventitial damage with local phenol application, selective renal 6-hydroxy dopamine infusion, renal sympathetic radiofrequency ablation therapies were used for hypertension treatment but orthostatic tachycardia, postural hypotension, erectile dysfunction, bladder and bowel problems were some adverse effects seen with mentioned therapy methods.

Taking medication every day for hypertension is very difficult for patients who use more than one medication and drug compliance is low. For this reason, alternative treatment methods are being studied. Selective renal denervation and carotid baroreceptor stimulation have not been shown to be effective in the treatment of hypertension. Renal arteries are innerved with afferent and efferent sympathetic nerves that enter adventitia. Efferent sympathetic stimulation increases renal vasoconstriction, decreases blood flow, increases renin activity, increases epinephrine and sodium reuptake. Afferent stimulation of the renal sympathetic nerves increases central sympathetic activity. The central role of sympathetic nerves in hypertension makes modulation of these nerves an important target for hypertension treatment. However, the mentioned carotid baroreceptor stimulation method is not successful in the treatment of hypertension. Similarly, denervation treatment of the perirenal nerves by angiographic RF waves is also not effective.

Neurostimulation can be done with passive microstimulators in micro size. Microstimulators can stimulate the nerves by taking the stimulus energy wirelessly and turning it into a stimulus. Removing the cable connections between the microstimulator and the external electronic circuitry increases implantation options in biological systems and can provide lifelong implant use.

Surgical or chemical sympathectomy treatments are very invasive and many side effects are observed.

Microsimulators do not contain active electronic circuits or contain very limited circuits and can be produced in millimeter-size. The power for microstimulators is usually through radio frequency waves easily conducted through the tissue. Power transmission with radio frequency waves is achieved by coaxial placement of transmitter and receiver antennas and inductive coupling. The choice of frequency to be used is determined by antenna size, depth of penetration in the tissue and required strength. 3-30 GHz frequency range provides a good balance between antenna size (1 -2 mm) and tissue penetration (1 -10 cm). The receiver antenna can be coiled or flat relative to the size of the microstimulator, or even thin film antennas are available. RF power transmission to microstimulators can be achieved by means of a transistor placed in the antenna. In the US patent no US2016008024 in the literature, the term "noninvasive, result-confirmed renal denervation procedures include evaluations made before, during, and after the ablation procedure. Stimulation procedures can be performed by ultrasound, other than ablation and i or heating operations, to determine the presence and / or condition of a kidney nerve in a targeted area. Consistent nerve ablation can be achieved (eg, in a spontaneous hypertensive patient) by evaluating the pathophysiology of renal denervation through blood pressure reduction and / or kidney and serum norepinephrine concentration"

In the mentioned application, the nerve in the adventitia of the renal artery with radiofrequency is ablated intermittently. Measurement is made in between and nerves are evaluated and ablation is performed according to blood pressure. Here, the procedure is performed with a catheter placed in the renal artery, and the catheter is retrieved.

Also in the literature, the US patent application no US20061 16736, in related to the subject: "The present invention discloses a method and apparatus for physiological modulation, including neural and gastrointestinal modulation, for the treatment of various disorders including obesity, depression, epilepsy and diabetes. This involves chronically implanted neural and neuromuscular modulators, modulating the afferent neurons of the sympathetic nervous system to cause satiety in obesity. Furthermore, this includes stimulation of sympathetic afferent fibers, including neuromuscular stimulation and intermittent smooth muscle contraction to increase the gastric intraluminal pressure causing satiety effect and stimulation of afferent sympathetic nerves."

In the mentioned application neuromuscular stimulation is disclosed in order to increase the feeling of satiety in the treatment of obesity.

It is also disclosed in the literature in U.S. Pat. No. US2016 / 0038087A1 , "Including a stent and a device containing a stent and / or a sensor placed on the stent. Some angled sensors are wireless sensors, which may include, for example, one or more fluid pressure sensors, contact sensors, position sensors, accelerometers, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolic sensors, mechanical stress sensors and / temperature sensors can be positioned. In some respects, these stents can be used to help stent placement, to monitor stent function, to detect complications of stenting, to monitor physiological parameters, and / or to use a body passageway, for example, to visualize a vascular lumen.

In the mentioned application, a stent with more than one diagnostic sensor on it and designed for diagnosis is described. There is a pressure sensor but the data from this sensor is only monitored. Data is not sent as feedback from the external control unit to the stent. There is no therapeutic function ot the invention related to the patent.

Due to the disadvantages mentioned above, it is necessary to establish a new aortic stent embodiment for use in the treatment of hypertension.

Description of the Invention

The object of the present invention is to provide a new aortic stent embodiment for hypertension treatment which removes the present disadvantages.

Another object of the invention is to provide a structure that can be placed interventionally to aorta at renal artery level without surgery.

Another object of the invention is to provide a neuromodulating structure that does not permanently damage the nerves.

Another object of the invention is to provide a structure that can be recharged wirelessly from the outside.

Another object of the invention is to provide a structure in which patients can continue their treatment for lifetime without a change.

Another object of the invention is to provide a structure that allows software and stimulation frequency changes to be made in pulse generator under the skin.

Another object of the invention is to provide a structure comprising an RF unit that can be worn on belt or implanted under the skin in the abdominal region. Another object of the invention is to provide blood pressure sensors and microstimulators located around the aortic stent and a structure regulating biood pressure by stimulating the blood pressure of the nerves around the renal artery and aorta with different algorithms.

Description of the Figures

Figure 1 - An illustrative representation of the aortic stent embodiment placed in the aorta at renal artery level for the treatment of hypertension.

Figure 2 - An illustrative representation of the aortic stent embodiment for the treatment of hypertension.

Figure - 3 An illustrative wireless stimulus induction in the aortic stent for the treatment of hypertension in the present invention

Figure - 4 An illustrative representation of the subcutaneous rechargeable external pulse generator and programming console in the aortic stent embodiment for hypertension treatment

Reference Numbers

Aortic Stent Assembly for Treatment of Hypertension

Aortic Stent

Microsimulator

Straight Antenna

Coil Antenna

Electronic Circuit

Blood Pressure Sensors

Kidney

Renal Artery

Aorta

Perirenal and Periaortic Nerves

Pulse Generator

Programming Console Detailed Description of the Invention

The innovation subject to the invention is described with examples for better understanding of the subject.

The invention is an aortic stent embodiment (A) for use in the treatment of hypertension; an aortic stent (1) implanted angiographically in to the aorta at renal artery level (8) at which perirenal and periaortic nerves (10) are situated, The microstimulators (2), which are placed 360 degrees around the stent and adjusts the neuromodulation by stimulating the perirenal and periaortic nerves (10) around the aorta (9) and renal artery (8), adjusts the RF energy of the different power, frequency and duration to the microstimulators characterized in that it comprises a blood pressure sensor (6) which determines the amount of stimulation to be given to the microstimulators (2) required for blood pressure regulation by detecting the blood pressure level on the aortic stent (1) and transmitting pulse generator (12).

Figure 1 shows an illustrative representation of the aortic stent embodiment (A) placed in the aorta for the treatment of hypertension.

Figure 2 shows an illustrative representation of the aortic stent embodiment (A) for the treatment of hypertension.

Figure 3 shows a representative view of the wireless stimulus induction in the aortic stent (1 ) for hypertension treatment, which is the subject of the invention.

Figure 4 shows a representation of the pulse generator (1 1) and the programming console (12) in the aortic stent embodiment (A) for the hypertension treatment.

The invention is an aortic stent embodiment (A) for use in the treatment of hypertension; an aortic stent (1 ) implanted angiographically in to the aorta at renal artery level (8) at which peril enal and periaortic nerves (10) are situated, The microstimulators (2), which are placed 360 degrees around the stent and adjusts the neuromodulation by stimulating the perirenal and periaortic nerves (10) around the aorta (9) and renal artery (8), adjusts the RF energy of the different power, frequency and duration to the microstimulators transmitted from pulse generator (1 1 ), a flat antenna (3) or coils (4) receiving RF waves from said pulse generator (1 1 ) on the microstimulator (2), said aortic stent (1 ) providing operation of said microstimulator (2) and electronic circuits (5) located on said aortic stent (1), the level of blood pressure on said aortic stent (12) main parts which externally charge and program the blood pressure sensor (6) and the pulse generator (11 ) which determine the amount of stimulation to be given to the microstimulators (2) required for blood pressure regulation.

An aortic stent (1) is placed into the aorta at mentioned renal artery (8) level over a 0.035 inch guide wire through a guide catheter introduced from the femoral artery with local anesthesia.

A pulse generator (1 1 ) is used to stimulate the perirenal and periaortic nerves (10) around the aorta (9) and renal artery (8) by mentioned aortic stent (1 ) Mentioned pulse generator (1 1 ) can be worn without implant or used as surgically implanted under the skin. So, the mentioned pulse generator (11 ) is positioned in a subcutaneous or wearable form.

Mentioned pulse generator (1 1 ) stimulates the microstimulators (2) which are arranged 360 degrees around said aortic stent (1 ) through radiofrequency energy transmission via flat antenna (3) or a coaxial antenna (4).

The blood pressure sensor (6) located on the mentioned aortic stent (1 ) determines the blood pressure level on mentioned aortic stent (1 ) and determines the amount of stimulation to be given to the microstimulators (2) required for blood pressure regulation.

The frequency at which the microstimulators (2) are stimulated is set by the programming console (12). The stimulation of the microstimulators (2) on mentioned aortic stent (1 ) is provided by the electronic circuit (5). Mentioned pulse generator (1 1 ) can be charged via the externally located programming console (12). The aortic stent embodiment (A), which is the subject of the present invention, differs from the current applications in that it externally stimulates the perirenal and periaortic nerves (10) to perform blood pressure reduction by neuromodulation without ablation.