WO2017146660A1

WO2017146660A1 - A system for decreasing the internal organ blood flow to alleviate hypotension, hypoglisemia and myocardial infarction with segmental non-invasive stimulation of sympathetic innervation to specific internal organs and their arterial smooth muscles

Info

Publication number: WO2017146660A1
Application number: PCT/TR2016/000018
Authority: WO
Inventors: Yusuf Ozgur CAKMAK
Original assignee: Koc Universitesi
Priority date: 2016-02-24
Filing date: 2016-02-24
Publication date: 2017-08-31

Abstract

Present application discloses a noninvasive blood flow decreasing system that decreases internal organ blood flow of a patient to alleviate low segmental sympathetic stimulation and high blood flow of specific internal organs related medical conditions, such as hypotension, hypoglycemia and heart attack. Said blood flow decreasing system comprises, at least one sensor for determining at least one blood related medical condition; at least two electrodes that are placed to skin dermatomal of said patient; at least one stimulator that sends electrical signals with a specific range of frequency to said electrodes and at least one control unit, which controls said stimulator according to the medical condition that is determined by said sensor.

Description

DESCRIPTION

A SYSTEM FOR DECREASING THE INTERNAL ORGAN BLOOD FLOW TO ALLEVIATE HYPOTENSION, HYPOGLISEMIA AND MYOCARDIAL INFARCTION WITH SEGMENTAL NON-INVASIVE STIMULATION OF SYMPATHETIC

INNERVATION TO SPECIFIC INTERNAL ORGANS AND THEIR ARTERIAL SMOOTH

MUSCLES

Field of Invention

The present invention relates to a system for stimulating the skin dermatomes noninvasive^ with a combination of a specific frequency and skin map in order to stimulate the corresponding spinal cord segment of sympathetic nerves that innervates liver, pancreas, adrenal glands and kidney as well as the smooth muscles of the arteries to abdominal branches of aorta, including arteries of kidney, adrenal gland, pancreas and liver by constriction of those arteries , to increase blood glucose and blood pressure and shifting the abdominal blood to thorax including the cardiac tissues like myocardium and coronary arteries to improve the perfusion in the medical cases where its needed. Prior Art

Hypotension is a medical condition, in which blood pressure in the arteries is lower than optimal values. Blood pressure is measured by two parameters; systolic (maximum) pressure and diastolic (minimum) pressure. Optimal values for said parameters for and adult are 140 mmHg and 90 mmHg respectively. When systolic blood pressure is below 90 mmHg or diastolic blood pressure is below 60 mmHg in a patient, said patient is usually considered having hypotension.

Hypoglycemia is a medical condition, in which glucose level of the blood plasma is relatively low (for example lower than 3,9 mmol/l or 70 mg/dl).

Both hypotension and hypoglycemia may threaten the life of a patient if they are not cured properly. Heart attack is a medical condition, in which blood flow stops to a part of the heart causing damage to the heart muscle. When a person has a heart attack, cardiac massage should be applied to the patient. Moreover, in order to increase blood flow to the heart, blood flow of the abdomen area of the patient should be decreased to shift the blood from abdominal arteries to the heart including coronary arteries and myocardium.

Therefore, in order to alleviate the effects of low segmental sympathetic stimulation and high blood flow to specific internal organs related medical conditions such as hypotension, hypoglycemia and heart attack, blood flow of specific organs or areas should be reduced. Although there are several blood flow decreasing systems are available, as disclosed in the documents US20031 14900A1 and US7226615B2, said applications are not organ specific. Therefore, said applications cannot be used for alleviate the effects of low segmental sympathetic stimulation and high blood flow to specific internal organs related medical conditions such as hypotension, hypoglycemia and heart attack.

Brief Description of Invention

Present application discloses a nonivasive blood flow decreasing system that decreases internal organ blood flow of a patient for eliminating dangerous effects of blood related medical conditions, such as hypotension, hypoglycemia and heart attack. Said blood flow decreasing system comprises, at least one sensor for determining at least one blood related medical condition; at least two electrodes that are placed to skin dermatomal of said patient; at least one stimulator that sends electrical signals with a specific range of frequency to said electrodes and at least one control unit, which controls said stimulator according to the medical condition that is determined by said sensor.

According to the present application, since electrodes are placed above the dermatomes (in other words since electrodes are placed to the skin), blood flow decreasing system is used by the patients easily. Moreover, according to the present application, nerves or arteries of the patient are not damaged. Therefore, blood flow of the patient is reduced easily and without causing any damage. Object of Invention

Object of the present application is to provide a system for decreasing blood flow of a specific organ or a specific group of organs of a patient with the aid of a non-invasive segmental sympathetic stimulation of the corresponding skin area, dermatomes.

Another object of the present application is to provide a system for decreasing blood flow of a specific organ or a specific group of organs of a patient with the aid of a non-invasive segmental sympathetic stimulation of the corresponding skin area, dermatomes in order to alleviate the medical conditions such as hypotension, hypoglycemia and heart attack.

Another object of the present application is to provide a wearable system for hypotension, hypoglycemia and heart attack based on segmental sympathetic stimulation of a specific organ and their arterial smooth muscles.

Detailed Description of Invention

Studies show that, in order to alleviate the medical conditions such as hypotension, hypoglycemia and heart attack, blood flow of different organs or areas of the patient should be reduced with improved sympathetic innervation to those organs and their arteries. Therefore, according to the present application a system for decreasing the blood flow is provided in order to eliminate such medical conditions.

Blood flow decreasing system of the present application comprises at least one sensor for determining at least one blood related medical condition, such as hypotension, hypoglycemia and heart attack, of a patient; at least two electrodes that are placed to skin dermatomal (a skin area that is supplied by a nerve) of said patient; at least one stimulator that sends electrical signals to said electrodes; and at least one control unit, which controls said stimulator according to the medical condition that is determined by said sensor. Said system may further comprise at least one power source (for example a rechargeable battery) for energizing the control unit and/or electrodes. In an alternative embodiment, blood flow decreasing system comprises a power generator that generated electrical power from the body (skin) of the user for energizing the control unit and/or electrodes. In a preferred embodiment of the present application, said signal has frequency 60-1 10 Hz (more preferably 80 Hz) or a burst frequency of 150-200 Hz with 80-100 Hz frequency. Current of the signal is preferably between 10-20 mA (more preferably 15 mA). Voltage of the signal is preferably between 1 -15 V (more preferably 5 V). Duration of the signal is preferably between 0, 1 -300 με (more preferably 100 με).

In an exemplary embodiment of the present application, said sensor measures the blood pressure level of the patient. In this embodiment, said electrodes are placed over the T10- S2 dermatomes (preferably T12 and/or L4), wherein one of said electrodes is used as anode and other one is used as cathode. When the blood pressure of the patient is reduces below a predetermined level, such as when systolic blood pressure reduces below 90 mmHg or diastolic blood pressure reduces below 60 mmHg, it is determined that hypotension situation occur. Then, said control unit activates said stimulator in order to send signals to the T12 and/or L4 dermatomes through the electrodes. Thanks to said signal, renal artery of the patient is shrunk and speed of the blood flowing through kidney is reduced and sympathetic stimulation to kidney and adrenal gland medulla are improved. Therefore, blood pressure level of the patient is increased. In another exemplary embodiment of the present application, said sensor measures the blood glucose level of the patient. In this embodiment, said electrodes are placed over the T7-S2 dermatomes (preferably T10 and/or L5), wherein one of said electrodes is used as anode and other one is used as cathode. When the blood glucose level of the patient is reduces below a predetermined level, such as 3,9 mmol/l or 70 mg/dl, it is determined that hypoglycemia situation occur. Then, said control unit activates said stimulator in order to send signals to the T10 and/or L5 dermatomes through the electrodes. Thanks to said signal, hepatic artery of the patient is shrunk and speed of the blood flowing through liver is reduced and sympathetic stimulation to liver and pancreas are improved. Therefore, blood glucose level of the patient is increased.

In another exemplary embodiment of the present application, said sensor measures the pulse of the patient in order to detect a heart attack condition. In this embodiment, said electrodes are placed over T7-S2 dermatomes (preferably T10 and T12 and/or L4 and L5), in order to reduce blood flow through the abdomen area. When a heart attack condition is sensed by said sensor, electrodes are energized through the control unit. Therefore, blood flow through the abdominal organ arteries is reduced, and most of the abdominal blood volume shifts to the heart and blood flowing through the heart is increased.

Studies show that, sympathetic nerves reaching to renal artery and kidney tissue stimulated the renin secretion, decreased urinary sodium excretion and decreased renal flow. Those cascades results with the increasing of blood pressure. In addition the sympathetic nerves that reaches to adrenal gland medulla with the aid of renal artery (a branch of renal artery that is called inferior adrenal artery), and also with other two arteries which are the branches of abdominal aorta (a branch called middle adrenal artery) and inferior phrenic artery(a branch called superior adrenal artery) stimulates the adrenaline and noradrenaline release to the blood so that another blood pressure raising mechanism occurs. Therefore in order to increase blood pressure, stimulation of sympathetic nerves to kidney and adrenal gland and their arteries is necessary. Stimulation of the sympathetic nerves to Kidney and Adrenal gland medulla is also results with the constriction of the renal and adrenal gland arteries because of the sympathetic nerves to those organs also innervated the smooth muscles of their arteries' walls. Similarly, sympathetic innervation (splanchnic nerves) to liver also innervates and elongates in the common hepatic artery, and hepatic artery proper and innervates their smooth muscles as well as decreasing liver glycogen content and causes an increased release of glucose (glycogenolysis) by increasing the activity of the liver glycogen phosphorylase and glucose-6-phosphatase enzymes in addition to partial inactivation of the phospharylase phosphatase activity. The sympathetic splanchnic nerves innervating the liver originate from neurons in the celiac and superior mesenteric ganglia, which are innervated by pre-ganglionic neurons located in the intermediolateral column of the spinal cord (T7-T 2) and the same spinal segments of sympathetic nerve system also gives collateral branches to related skin segments, dermatomes. In addition to sympathetic innervation of liver, the sympathetic nerves on the coeliac trunk pass to the common hepatic artery and then they elongates into the pancreas after giving branches to liver with the aid hepatic artery proper. Sympathetic innervation to pancreas inhibits pancreatic beta cells to secrete insulin and aid to keep the state of hyperglycemia. Overall, the stimulation of the liver, pancreas and arteries to those organs including common hepatic artery and hepatic artery proper and organs with the aid of a adequate combination of frequency and related electrodes placed on skin segment related with liver, pancreas and their arteries results with the sympathetics over the common hepatic artery do act more over the liver by stimulating the glucogenolysis (glucose production and secretion to blood) but also act through the pancreas by boosting the inhibitory action of sympathetic nerve system over insulin secretion, so that insulin can not be secreted to the blood to take the glucose to tissues and as a consequence the levels of the blood glucose will be increased. Moreover, sympathetic stimulation to pancreas also increases glucagon secretion from pancreas, and the glucagon hormone which acts on liver cells that have its receptors and stimulates gluconeogenesis (new glucose synthesis) and glycogenolysis (production of glucose from glucogen storages) so that blood glucose elevates. In the case of a corresponding skin segment stimulation with the a combination of skin map and frequency, the sympathetic stimulation over the common hepatic artery, not only results with improved sympathetic stimulation to liver but to the pancreas obtained, so that insulin secretion blockade will also be obtained but also the glucagon secretion is also be improved and as a consequence dual action to increase blood glucose obtained through pancreas in addition to liver. Glucagon is also act on kidney to produce glucose via gluconeogenesis (new glucose production) so that non-invasive stimulation of sympathetic nerves over the common hepatic artery with corresponding skin stimulation is also stimulates the glucose production of kidney with aid of glucagon secretion in the pancreas.

Moreover, the sympathetic nerve system also reaches to pancreas with the aid of superior mesenteric artery, a branch of abdominal aorta. 0,5 cm below the coeliac trunk of which the common hepatic artery originates. The segmental skin stimulation with the adequate combination of frequency and skin map placement of electrodes also stimulates the sympathetics on the superior mesenteric artery so that it improves the dual sympathetic stimulation to pancreas: through common hepatic artery and through superior mesenteric artery.

Since the sympathetic nerves to liver and pancreas pass through the arteries, common hepatic artery and hepatic artery proper, they also stimulate the smooth muscles of those arteries. So in the case of a sympathetic nerve stimulation, the smooth muscles of the arterial walls are also be stimulated and as a consequence the constriction of the arteries are observed. Our researches revealed the constriction of those arteries with the segmental skin stimulation. According to an experiment, wherein two electrodes are placed over T10 and L5 dermatomes and 80 Hz signal is sent to said electrode,

- flow rate of the blood passing through hepatic artery proper is reduced from 230 cc/min to 144 cc/min,

- flow rate of the blood passing through cealiac trunk is reduced from 819 cc/min to 485 cc/min,

- flow rate of the blood passing through superior mesenteric artery is reduced from 922 cc/min to 729 cc/min,

- flow rate of the blood passing through left renal artery is reduced from 445 cc/min to 395 cc/min and

- flow rate of the blood passing through right renal artery is reduced from 769 cc/min to 527 cc/min.

Briefly, reducing the blood flow rate of the renal artery and adrenal gland arteries increases blood pressure level as a result of sympathetic stimulation to kidney, adrenal gland medulla and their arteries as well, and reducing the blood flow rate of the common hepatic artery, hepatic artery proper and superior mesenteric artery increases blood glucose level with a combined mechanism over liver, pancreas and kidney.

In another preferred embodiment of the present application, blood flow decreasing system comprises one set of electrodes (for example an electrode pair) that are placed over one dermatome and another set of electrodes (for example an electrode pair) that are placed over another dermatome. In this embodiment, signals sent to different set of electrodes are able to be controlled separately (for example frequency and or voltage level of the electrodes placed over a dermatome can be different from the frequency and or voltage level of the electrodes placed over the other one). By controlling said set of electrodes separately, blood flow reduction effect of the system is boosted.

In another preferred embodiment of the present application, three different sets of electrodes are able to be used, wherein one set to be used for reducing the blood flowing through kidney, one set to be used for reducing the blood flowing through liver and another set to be used for reducing the blood flowing through abdomen area. In this embodiment, said sensor determines the hypotension, hypoglycemia and heart attack situations and according to the determined medical situation, only the related electrodes are energized. In another preferred embodiment of the present application, blood flow decreasing system comprises at least one screen. Said screen informs users about their medical conditions, that measured by said sensor (such as blood glucose level, blood pressure level and pulse) and/or operation status of the stimulator (for example signal parameters). Optimum signal parameters for reducing the blood flow may vary for different individuals. Said parameters may depend on age, weight, height and gender of the patient. Therefore, in another preferred embodiment of the present application, blood flow decreasing system comprises at least one input means (for example a keyboard or a touchscreen) to control signal parameters. In an exemplary embodiment, users are able to enter their age, weight, height, and gender information through said input means. In another exemplary embodiment, users directly changes optimum signal parameters manually. In order to change said parameters manually, optimum parameters for one individual may be found by a physician prior to use of the blood flow decreasing system. In another preferred embodiment of the present application, said control unit comprises means for monitoring the current level of the signal that are sent to said electrodes. In this embodiment, if the current level drops below a predetermined level, control unit increases the voltage of the signal in order to increase the current level above said predetermined level. In alternative embodiments, said control unit may comprise means for monitoring the frequency and/or wavelength (duration) of the signal. Therefore, it is ensured that signal parameters are correct.

In another embodiment, control unit comprises at least one short circuit control element. In this embodiment, if a short circuit situation occurs (for example because of misplacing the electrodes); signal sent to the electrodes is cut. Therefore, damaging the electrodes or control unit is prevented.

In another embodiment of the present application, blood flow decreasing system of the present application comprises at least one remote control unit and at least one transmitter, which receives commands from said remote control and control the control unit according to the received commands. In this embodiment, by using remote control unit, said signal could be sent to the electrodes manually even if no medical condition is detected by said sensor. Therefore, it is ensured that blood flow of a patient decreases for a critical operation (for example during a surgery). In another preferred embodiment of the present application, control unit comprises at least one open circuit control element.

In this embodiment, if electrical connection between electrodes is cut (for example because of damaging at least one electrode) users are able to be notified. In order to notify the user, blood flow decreasing system comprises at least one alarming unit (for example a buzzer or a warning light).

In another preferred embodiment of the present application, each of said electrodes comprises an anode or a cathode connection and a pair of anode and cathode connection. In this embodiment, said electrodes are called intelligent electrodes. During the normal use of the blood flow decreasing system, anode connection of one electrode and cathode connection of other electrode is used for transmitting signals to the dermatomes. If any open circuit situation occurs, for example if one of the electrodes is damaged, signal is transmitted to the dermatomes through pair of anode and cathode connection of other electrode.

In another preferred embodiment of the present application, blood flow decreasing system comprises at least one temperature sensor, which measures the temperature of the electrodes and skin of the user, and at least one temperature adjusting unit, which adjusts the temperature of the electrode according to the temperature values measured by said temperature sensor. In this embodiment, if temperature of the electrode is higher than the temperature of the skin of the user, said temperature adjusting unit decreases the temperature of the electrode. Similarly, if temperature of the electrode is lower than the temperature of the skin of the user, said temperature adjusting unit increases the temperature of the electrodes. Therefore, it is ensured that said electrodes do not damage the skin of the user because of a high or low temperature.

According to the present application, since electrodes are placed above the dermatomes (in other words since electrodes are placed to the skin), blood flow decreasing system is used by the patients easily. Moreover, according to the present application, nerves or arteries of the patient are not damaged. Therefore, blood flow of the patient is reduced easily and without causing any damage.

Claims

A blood flow decreasing system for segmental internal organ specific sympathetic nerve stimulation that eliminates dangerous effects of blood related medical conditions, characterized by comprising;

- at least one sensor for determining at least one blood related medical condition;

- at least two electrodes that are placed to skin dermatomal of said patient;

- at least one stimulator that sends electrical signals to said electrodes and

- at least one control unit, which controls said stimulator according to the medical condition that is determined by said sensor.

A blood flow decreasing system according to claim 1 , characterized in that; said signal has frequency 60-1 10 Hz.

A blood flow decreasing system according to claim 2, characterized in that; said signal has frequency 80 Hz.

A blood flow decreasing system according to claim 1 , characterized in that; said signal has frequency has a burst frequency of 150-200 Hz with 8-100 Hz frequency.

A blood flow decreasing system according to claim 1 , characterized in that; current of the said signal is between 10-20 mA

A blood flow decreasing system according to claim 1 , characterized in that; current of the said signal is 15 mA.

A blood flow decreasing system according to claim 1 , characterized in that; voltage of said signal is between 1-15 V

8. A blood flow decreasing system according to claim 1 , characterized in that; voltage of said signal is 5 V.

9. A blood flow decreasing system according to claim 1 , characterized in that; duration of said signal is between 0,1 -300 με

10. A blood flow decreasing system according to claim 1 , characterized in that; duration of said signal is 100 ps.

11. A blood flow decreasing system according to claim 1 , characterized by further comprising; at least one power source for energizing the control unit and/or electrodes.

12. A blood flow decreasing system according to claim 1 , characterized by further comprising; at least one power generator that generated electrical power from the body of the user for energizing the control unit and/or electrodes.

13. A blood flow decreasing system according to claim 1 , characterized by further comprising; at least one screen.

14. A blood flow decreasing system according to claim 1 , characterized by further comprising; at least one input means.

15. A blood flow decreasing system according to claim 1 , characterized in that; said control unit comprises means for monitoring the current level of the signal that are sent to said electrodes.

16. A blood flow decreasing system according to claim 1 , characterized in that; control unit comprises at least one short circuit control element.

17. A blood flow decreasing system according to claim 1 , characterized by further comprising; at least one remote control unit and at least one transmitter, which receives commands from said remote control and control the control unit according to the received commands.

18. A blood flow decreasing system according to claim 1 , characterized in that; control unit comprises means for monitoring the frequency of the signal.

19. A blood flow decreasing system according to claim 1 , characterized in that; control unit comprises means for monitoring the wavelength of the signal.

20. A blood flow decreasing system according to claim 1 , characterized in that; control unit comprises at least one open circuit control element.

21. A blood flow decreasing system according to claim 21 , characterized by further comprising; at least one alarming unit.

22. A blood flow decreasing system according to claim 1 , characterized in that; each of said electrodes comprises an anode or a cathode connection and a pair of anode and cathode connection.

23. A blood flow decreasing system according to claim 1 , characterized by further comprising; at least one temperature sensor, which measures the temperature of the electrodes and skin of the user, and at least one temperature adjusting unit, which adjusts the temperature of the electrode according to the temperature values measured by said temperature sensor.