High-efficiency extracorporeal counterpulsation system and treatment method using this system

Abstract

The present invention provides an extracorporeal counterpulsation (ECP) system and a method for improving circulatory and cardiovascular-related diseases using this system. The ECP system of the present invention includes a spiral air sac for regulating blood flow in the major veins and arteries of the thigh. By realizing high efficiency through the spiral shape of the air sac, the cost, weight, and size of the ECP system of the present invention are reduced.

Description

Technology Field

[0001] The present invention relates to a high-efficiency extracorporeal counterpulsation system and a treatment method using the system. Specifically, the present invention comprises one or more air bags that utilize the helical geometry of major veins and arteries in the user's thigh to achieve high efficiency. Background Technology

[0002] External Counter Pulsation (ECP) is a clinically proven therapeutic system for various diseases, such as intractable angina, acute myocardial infarction, congestive heart failure, and ischemia-related conditions, by modulating hemodynamic properties using air bags placed in the legs. Other applications are currently being explored in neurology and nephrology. However, current ECP systems are expensive, large, heavy, and stationary. One reason for this is the need for high-power air compressors to operate the ECP system. Consequently, since ECP systems can only be purchased and stored at hospitals and clinics, patients must be transported to receive ECP treatment.

[0003] The design of the air bag can significantly affect the efficiency of the ECP system, including mechanical dimensions and power consumption. The present invention discloses a novel spiral air bag-based high-efficiency ECP system that efficiently regulates blood flow by compressing the major arteries and veins of the femur relative to the femur using a spiral method in which the spiral air bag wraps around the major arteries and veins of the femur. Thus, the arteries are compressed by both the acting force of the spiral air bag and the reaction force of the femur, thereby maximizing the utilization of the applied air pressure. An auxiliary bag is added to one end of the spiral air bag to further restrict the movement of the compressed arterial blood in a desired direction. A special cuff housing the air bag is designed to ensure high air pressure delivery efficiency to the arteries. The present invention discloses an entire air piping loop and a related control method for realizing a high-efficiency ECP system. The efficiency realized by the present invention using a new spiral air bag significantly reduces air compressor power requirements, thereby reducing the size, weight, and cost of the ECP system of the present invention, making it possible to own and maintain the ECP system of the present invention at home. Prior art literature

[65535] U.S. Patent Application Publication US2010 / 0160795 means of solving the problem

[0004] The present invention relates to an extracorporeal counterpulsation (ECP) device, wherein the extracorporeal counterpulsation (ECP) device is an air bladder system comprising one or more spiral air bladders and one or more auxiliary air bladders, wherein each spiral air bladder is shaped to form a spiral around the thigh that closely follows the major arteries and / or veins surrounding the femur when the spiral air bladder is pressurized to affect the regulation of blood flow within the major arteries and veins surrounding the femur when attached to the thigh of a user; and a valve and fluid system pneumatically connected to the air bladder system and configured to pressurize / depressurize the spiral air bladder and the auxiliary air bladder. And a control system comprising a processor, one or more PPG sensors and one or more ECG sensors, wherein the PPG sensors and the ECG sensors are connected to a user to collect PPG signals and ECG signals from a user, and the control system is electronically connected to the valve and fluid system to control the valve and fluid system, thereby pressurizing or depressurizing the air bag of the air bag system based on signals detected by the sensors.

[0005] In one embodiment, the dimensions of the spiral air sac are determined by the user's anatomical structure so that the spiral air sac can closely follow the major arteries and veins of the user's thigh. In another embodiment, the length L (cm) of the spiral air sac is determined by the user's height / 3.2 - b, where b is 15 cm to 30 cm, the upper width and lower width of the spiral air sac are each about 14 cm, and the spiral angle is about 55°. In yet another embodiment, the wattage of the valve system is less than about 1500 watts.

[0006] In one embodiment, the spiral air pocket length L does not exceed 50 cm, W1 and W2 do not exceed 25 cm, and the area is 1250 cm² 2 It does not exceed. In another embodiment, the pressure inside the spiral air bag does not exceed 350 mmHg when fully pressurized. In another embodiment, the pressure of the spiral air bag does not fall below about 150 mmHg when fully pressurized. In yet another embodiment, the ratio of the upper width W1 of the spiral air bag to the lower width W2 of the spiral air bag is about 1:1 to 2:1.

[0007] In one embodiment, the spiral angle of the spiral air bag is approximately 30° to 75°. In another embodiment, the auxiliary air bag is positioned at the bottom of the spiral air bag while overlapping with the spiral air bag. In yet another embodiment, the auxiliary air bag is positioned at the bottom of the spiral air bag while not overlapping with the spiral air bag.

[0008] In one embodiment, the auxiliary air bladder is positioned at the top of the spiral air bladder while overlapping with the spiral air bladder. In another embodiment, the auxiliary air bladder is positioned at the top of the spiral air bladder without overlapping with the spiral air bladder. In yet another embodiment, the auxiliary air bladder and the spiral air bladder are in a single cuff.

[0009] The present invention also relates to a method for providing extracorporeal counterpulsation therapy using the extracorporeal counterpulsation (ECP) device of the present invention, the method comprising: a. detecting the R peak of a user's heartbeat; b. introducing a delay period of about 10 ms to 250 ms from the R peak; c. pressurizing an auxiliary air bag; d. introducing a delay period of about 20 ms to 100 ms; e. pressurizing a spiral air bag for a therapeutic effective time of about 200 ms to 600 ms; f. depressurizing the auxiliary air bag and the spiral air bag almost simultaneously; and g. repeating steps a through f for a therapeutic effective time. Brief explanation of the drawing

[0010] FIG. 1 is a drawing showing a spiral structure of the main artery and vein in the user's thigh and an embodiment of the spiral air sac of the present invention (10). Figure 2 is an upper-level block diagram of the present invention (10). FIG. 3 is a detailed view of one embodiment of the spiral cuff (105) and auxiliary cuff (160) of the present invention. FIGS. 4a and FIGS. 4b are drawings showing two different possible arrangements of the spiral cuff (105) and auxiliary cuff (160) of the present invention. FIGS. 4c and 4d are drawings showing two different possible arrangements of the spiral air bag (110) and the auxiliary air bag (170) when both the spiral air bag (110) and the auxiliary air bag (170) are configured within a single cuff. FIGS. 5A and 5B are drawings illustrating the pressurization and depressurization cycles of the ECP device (10) of the present invention related to the cardiac cycle and blood flow when an auxiliary air bag (170) is placed at the bottom of the spiral air bag (110). FIGS. 6a and 6b are drawings showing the pressurization and depressurization cycles of the ECP device (10) of the present invention regarding the heart cycle and blood flow when an auxiliary air bag (170) is placed at the top of the spiral air bag (110). FIG. 7 is a block diagram showing one embodiment of the ECP control unit (200) of the present invention. FIG. 8 is a block diagram showing one embodiment of the ECP control unit (200) and fluid and valve system (300) of the present invention. FIG. 9 is a block diagram showing one embodiment of the fluid and valve system (300) of the present invention. FIG. 10 is a flowchart illustrating one embodiment of a method of using the ECP device (10) of the present invention. FIG. 11 is a combination of a PPG chart and an ECG chart with charts showing the pressurization and depressurization of a spiral air bag (110) and an auxiliary air bag (170), said charts are time-synchronized to illustrate one embodiment of a treatment method using the ECP device (10) of the present invention. FIGS. 12a and FIGS. 12b respectively show exemplary PPG and ECG signals of a user before and during treatment using the ECP device (10) of the present invention. FIG. 13 is a drawing of one exemplary embodiment of the ECP control system (200) and fluid and valve system (300) of the ECP device (10) of the present invention. Specific details for implementing the invention

[0011] As used in this specification and the claims below, the singular expressions “one,” “one,” and “the one” include multiple references unless the context clearly indicates otherwise. Accordingly, for example, a reference to “one component” includes a mixture of several components, and a reference to “one active agent” includes more than one number of active agents, etc.

[0012] As used in this specification, the expression “about” as a modifier for the amount means that it includes an adjusted amount of + or - 5%.

[0013] The term "effective time" or "treatment effective time" refers to the sufficient time required to provide the desired therapeutic effect while remaining non-toxic and harmless. The "effective" period may vary for each patient depending on their age, general condition, specific circumstances, and other factors.

[0014] The ECP device (10) of the present invention can achieve a smaller size, lower energy consumption, and lower device cost compared to an ECP device of the prior art. This is possible because the ECP device (10) of the present invention utilizes the geometric structure of the major arteries and veins of the femur that spiral around the femur as shown in FIG. 1. Specifically, as shown in FIG. 1, the major arteries and veins start in front of the femur in front of the pelvic bone, spiral around the femur toward the inner thigh, and end behind the femur behind the knee before moving further down the leg. As shown in FIG. 1, the spiral air sac (110) is specially formed to utilize this specific anatomical structure so that the air sac (110) concentrates its energy only on the part of the femur where it is needed to press the major veins and arteries against the femur, in order to regulate blood flow of the major arteries and veins without wasting energy on other parts of the femur. The efficiency achieved means that a much smaller and less powerful air compressor is required to achieve the same or better treatment results compared to existing ECPs. For example, the power consumption of the present invention is less than about 500, 600, 700, 800, 900, 1000, 1250, or 1500 watts compared to the energy consumption of about 2500 watts of a typical commercial device currently available. In addition, due to the miniaturization, the ECP device (10) of the present invention is easy to handle and even portable, weighing less than about 20, 25, or 30 kg, and is significantly less expensive than existing ECP devices that are typically too heavy and therefore made to be stationary. This means that the user can easily own and operate the ECP device (10) of the present invention at home without needing to travel to a hospital for treatment.

[0015] FIG. 2 is a high-level depiction of the ECP device (10) of the present invention, including an air bag system (100), a control system (200), and a valve and fluid system (300).

[0016] FIG. 3 illustrates an embodiment of a cuff system (100). As illustrated in FIG. 3, the spiral cuff system (100) comprises a spiral cuff (105) and a spiral air pocket (110). In one embodiment, the spiral air pocket (110) comprises an upper width W1 (112), a lower width W2 (114), a length L (116), and a spiral angle (118), wherein the length L (116) is a straight line between the midpoint of the upper width W1 (112) and the midpoint of the lower width W2 (114). The spiral angle (118) is the angle between the length L (116) and a horizontal line parallel to the flat ground when the user is standing upright and wearing the cuff. If the lower width W2 is designed to be parallel to this horizontal line as illustrated in FIG. 3, the spiral angle will be the angle between the lower width W2 and the length L (116). In another embodiment, the spiral cuff (105) further includes one or more cuff fasteners (120).

[0017] In the above-described embodiment, the spiral air sac (110) is placed over the major artery and / or vein of the inner thigh so that the spiral shape of the air sac (110) follows the major artery and vein surrounding the femur as illustrated in FIG. 1. To better fit the major artery and / or vein surrounding the femur, the upper width W1 (112), lower width W2 (114), length L (116), and spiral angle (118) may vary depending on factors such as the user's biometrics, such as gender, height, weight, BMI, age, etc., and the placement location. In one embodiment, the spiral angle (118) is about 30° to 75°, 40° to 65°, or about 55°. In one embodiment, the upper width W1 (112) of the spiral air sac is wider than the lower width W2 (114), as illustrated in FIG. 3. In another embodiment, the ratio of W1 (112):W2 (114) is about 2:1 to 1:1, about 1.9:1 to 1.1:1, about 1.8 to 1.2:1, about 1.7:1 to 1.3:1, about 1.6:1 to 1.4:1, or about 1.5:1. The fact that W1 (112) is wider than W2 (114) helps to send blood upward toward the torso when the spiral air sac (110) is inflated as shown in FIG. 4a and FIG. 4c. In one embodiment, the ratio of the upper width W1 (112) of the spiral air sac (110) to the length L (116) of the spiral air sac (110) is about 1:2 to 1:4 or about 1:3.

[0018] In one embodiment, the spiral air pocket (110) covers only the thigh portion. In another embodiment, the spiral air pocket (110) does not cover the entire thigh but covers only the portion above the major artery or vein above the femur sufficient to therapeutically regulate blood flow as needed so that the entire cuff system (100) and ECP device (10) can be miniaturized. In one embodiment, L (116), W1 (112), and W2 (114) depend on the user's biometric information, such as the user's height and / or weight. For example, in one embodiment, L = (user height / 3.2) - b, where b is about 15 cm to about 30 cm. Thus, if the user's height is 165 cm, L may be about 21.6 cm to 36.6 cm, W1 (112) is about 14 cm, and W2 (114) is about 14 cm.

[0019] In one embodiment, as illustrated in FIG. 3, the ECP device (10) of the present invention further comprises an auxiliary cuff (160). In one embodiment, the auxiliary cuff (160) comprises an auxiliary air bag (170), which helps the spiral air bag (110) regulate blood flow toward or away from the user's torso, as described in more detail below in relation to FIG. 4 through 6. As with design considerations for the spiral air bag (110), the width W (180) and length L (185) of the auxiliary air bag (170) must be minimized to reduce the output and size requirements of the air compressor used to pressurize the auxiliary air bag (170), as further described in relation to FIG. 4, but still provide adequate assistance to the spiral air bag (110). However, the width W (180) of the auxiliary air bag (170) must be wide enough to completely encompass the width W2 (114) of the spiral air bag (110) when the auxiliary cuff (160) is positioned at the bottom of the spiral cuff (105) as shown in FIG. 4a and 4c, or the width W1 (112) of the spiral air bag (110) when the auxiliary cuff (160) is positioned at the top of the spiral cuff (105) as shown in FIG. 4b and 4d. Additionally, as described below with a different configuration in relation to FIG. 4, the length L (185) and width W (180) of the auxiliary air bag (170) must be sized to provide adequate force to help the spiral air bag (110) regulate blood flow in the desired direction, and the pressure provided by the air compressor must be high enough to provide adequate force to help the spiral air bag (110) regulate blood flow in the desired direction. In one embodiment, the ratio of the width W (180) to the length L (185) of the auxiliary air bag (170) is about 1.It is 5:1 to 4:1, about 2:1 to 3:1, or about 2.5:1. In another embodiment, the width W (180) of the auxiliary air bag is about 8 cm to 30 cm, about 16 cm to 24 cm, or about 22 cm.

[0020] In one embodiment as illustrated in FIGS. 4a through 4d, an auxiliary air pocket (170) may be positioned over the spiral air pocket (110) in a different configuration. In one embodiment, the auxiliary air pocket (170) may be positioned over the bottom of the spiral air pocket (110) as illustrated in FIG. 4a. In one embodiment, the auxiliary air pocket (170) contacts the bottom of the spiral air pocket at the bottom of the width W2 (114) and overlaps with the spiral air pocket (110). In another embodiment, the spiral air pocket (110) and the auxiliary air pocket (170) may be formed in a single cuff as illustrated in FIG. 4c.

[0021] In another embodiment, as shown in FIG. 4b, an auxiliary air pocket (170) may be positioned over the top of the spiral air pocket (110). In one embodiment, the auxiliary air pocket (170) contacts the top of the spiral air pocket at the top of the width W1 (112) and overlaps with the spiral air pocket (110). In another embodiment, the spiral air pocket (110) and the auxiliary air pocket (170) may be formed in a single cuff as shown in FIG. 4d.

[0022] In one embodiment, the auxiliary air bag (170) is pressurized before the spiral air bag (170) to influence the direction of blood flow when the spiral air bag (110) is subsequently pressurized. Specifically, as illustrated in FIG. 5, when the auxiliary air bag (170) is positioned at the bottom of the spiral air bag (110) and the auxiliary air bag (170) is pressurized before the spiral air bag (110), the direction of most of the blood flow caused by the cuff system (100) is first directed upward toward the user's torso because the auxiliary air bag (170) blocks the blood flow flowing downward. In one embodiment, the auxiliary air bag (170) must be wide enough to cover at least the entire width (W1) (112) of the spiral air bag. Additionally, the air pressure of the auxiliary air bag (170) must be high enough to stop about 90%, about 80%, about 70%, or about 60% or more of the blood flow flowing downward when pressurized. In one embodiment, the pressure of the air bags (110, 170) is about 150 mmHg to 350 mmHg, about 200 mmHg to 300 mmHg, or about 250 mmHg. Subsequently, when both air bags (170, 110) are depressurized, most of the blood flow caused by the cuff system (100) is diverted downward from the user's torso. And in FIG. 6, in an embodiment where the auxiliary air bag (170) is located in the upper half of the spiral air bag (110) and the auxiliary air bag (170) is pressurized before the spiral air bag (110), most of the blood flow caused by the cuff system (100) is directed downward first toward the user's feet because the auxiliary air bag (170) blocks the upward blood flow. Subsequently, when both air bags (170, 110) are depressurized almost simultaneously, most of the blood flow caused by the cuff system (100) is directed upward toward the user's torso.Accordingly, the air pressure of the auxiliary air bag (170) must be high enough to stop about 90%, about 80%, about 70%, or about 60% or more of the blood flow flowing upward when pressurized. In one embodiment, the pressure within the air bag (110, 170) is about 150 mmHg to 350 mmHg, about 200 mmHg to 300 mmHg, or about 250 mmHg. As illustrated in FIGS. 5 and 6, the placement of the air bag (110, 170) allows the user to target different parts of the body with different treatment intensities.

[0023] In one embodiment, as illustrated in FIG. 7, the ECP device (10) of the present invention further comprises an ECP control system (200) configured to control various aspects of the ECP device (10) of the present invention, including, as a non-limiting example, interaction with a user, collection and analysis of the user's biometric information, and interaction with a valve system (300) for pressurizing / depressurizing the air bag (110, 170). In one embodiment, the ECP control system (200) preferably comprises an ECP processor (210), one or more heart rate sensors (220, 230, 240), and an interactive display unit (250). In one embodiment, the ECP processor (210) is connected to the interactive display unit (250) and the heart rate sensors (220, 230, 240) via an electronic connection (260). Additionally, in one embodiment, the ECP processor (210) is further connected to the valve and fluid system (300) through an electronic connection (260), as described in more detail below in relation to FIGS. 8 and FIGS. 10.

[0024] In one embodiment, the ECP processor (210) preferably includes a processor configured to transmit, receive, and process various signals, including, as a non-limiting example, signals related to the user’s biometric information, such as heart rate information collected by heart rate sensors (220, 230, 240), as well as signals to and from the user via an interactive display unit (250), and signals to and from the valve and fluid system (300). Thus, the ECP processor (210) is configured to control various aspects of the ECP device (10) of the present invention, such as the pressure of the spiral air bag (110) and the auxiliary air bag (170), based on the various signals processed.

[0025] As illustrated in FIG. 7, in one embodiment, the PPG heart rate sensor (220) may include a finger sensor (220a) and two toe sensors (220b, 220c). In one embodiment, the ECG heart rate sensor (230) may include left and right chest sensors (230a, 230b). Additionally, the ECG heart rate sensor (230) may further include a leg sensor (230c). In one embodiment, the continuous blood pressure sensor (240) includes a blood pressure cuff on the user's arm.

[0026] The display (250) is preferably a touchscreen that enables a user to interact with the ECP device (10) of the present invention, such as triggering ECP treatment, inputting user information, and setting system settings. User information may include the user's biometric information, such as gender, height, weight, BMI, age, etc. Input information may include system settings information, such as the type and duration of ECP treatment, and maximum and / or minimum pressure. Output information may include the type of treatment, treatment progress, etc.

[0027] In one embodiment, as illustrated in FIGS. 8 and 9, the ECP device (10) of the present invention further comprises a valve and fluid system (300), and the valve and fluid system (300) operates in conjunction with an ECP control system (200) to control the pressure within the ECP device (10) of the present invention, including the pressure within the valve and fluid system (300) as well as the curve system (100). In one embodiment, the valve and fluid system (300) comprises one or more air bag valves (310), a post-adjustment air compartment (320), an air pressure ratio adjustment valve (330), an air compressor air compartment (340), an air compressor (350), a transducer (360) that converts air pressure into an electrical signal, an air inlet valve (370), an air inlet (375), and a series of large airways (380) and small airways (390, 395). In one embodiment, the large airway (380) used to create negative pressure has a diameter of about 1 cm to 10 cm, and the small airway (390, 395) has a diameter of about 0.4 cm to 2 cm.

[0028] In one embodiment, each air bag valve (310) preferably includes a valve configured to regulate the pressure of the cuff system (100) based on an electronic signal received from the ECP control system (200). In one embodiment, the air bag valve (310) is a solenoid valve. The post-adjustment air chamber (320) preferably includes an air chamber capable of storing compressed air to pressurize the air bags (110, 170). In one embodiment, the pressure within the post-adjustment air chamber (320) is 150 mmHg to 350 mmHg, 200 mmHg to 300 mmHg, or about 250 mmHg. Each valve (310a, 310b) is connected to the post-adjustment air chamber (320) through an airway (390) on one side and connected to the spiral air bag (110) and auxiliary air bag (170) through an airway (395) on the other side of the valve. Each valve (310) is additionally connected to an air inlet valve (370) and a compressor (350) through an airway (380), and the air bags (110, 170) can be depressurized through the airway (38). In addition, each valve (310) is electronically connected to an ECP processor (210) through an electronic connection (260) so that the ECP processor (210) can electronically operate the valve (310) to pressurize / depressurize the air bags (110, 170).

[0029] In one embodiment, the air compressor air chamber (340) includes an air chamber connected to the adjusted air chamber (320) via an air pressure ratio adjusting valve (330). In one embodiment, the air pressure ratio adjusting valve (330) is connected to an ECP processor (210) via an electronic connection (260). In this way, the air pressure ratio adjusting valve (330) is configured to maintain the air pressure in the two air reservoirs (320, 340) based on a signal from the ECP processor (210). In one embodiment, the air pressure in the adjusted air reservoir (320) is maintained at about 150 mmHg to 350 mmHg, 200 mmHg to 300 mmHg, or about 250 mmHg, while the air pressure in the compressor air reservoir (340) is maintained at about 4 kgf to 8 kgf, about 5 kgf to 7 kgf, or about 6 kgf.

[0030] In one embodiment, the air compressor (350) comprises an air compressor configured to provide positive pressure to the airway (390) when the air inlet valve (370) is open and to provide negative pressure to the airway (380) when the air inlet valve (370) is closed to the air inlet (375) in order to facilitate replenishing air to the air compartment (340) and depressurizing the air bags (110, 170), respectively. In one embodiment, the air compressor (350) may operate at approximately 1700 rpm at a pressure of approximately 8 kgf or less and a flux of approximately 130 L / m. The air inlet valve (370) preferably comprises a valve connected to the compressor (350) through the airway (380) at one end and connected to the air inlet (375) at the other end. In one embodiment, the air inlet valve (370) comprises a solenoid valve.

[0031] Finally, the transducers (360) preferably each include a transducer that converts pressure into an electrical signal. Each transducer (360) is preferably connected to one of the air chambers (340, 320) and to the ECP control processor (210) through the airway (390) on one side. In this way, the valve system (300) is configured to transmit air pressure information to the ECP control system (200) through the transducers (360). As described above, the ECP control processor (210) is connected to the solenoid valve (310), the air pressure ratio adjustment valve (330), the air inlet valve (370), and the air compressor (350), so that the ECP control system (200) is configured to transmit electronic signals to control the valves (330, 370) and the air compressor (350) based on the air pressure information from the transducers (360a, 360b).

[0032] In one embodiment, when the ECP processor (210) transmits a signal to the valve (310), the valve (310) pressurizes the air bag (110, 170) by connecting the air bag (110, 170) to the air chamber (320) and supplying compressed air to the air bag (110, 170). To depressurize the air bag (110, 170), the ECP processor (210) stops transmitting a signal to the valve (310) so that the valve (310) disconnects the air bag (110, 170) from the air chamber (320) according to the default setting and instead connects the air bag (110, 170) to the airway (380). Additionally, the ECP processor (210) can signal the air inlet valve (370) to close the air inlet so that the compressor (350) generates negative pressure in the airway (380) to rapidly depressurize the air bags (110, 170). In one embodiment, the negative pressure in the airway (380) is about 80 mmHg to 120 mmHg, about 90 mmHg to 110 mmHg, or about 100 mmHg.

[0033] FIG. 10 illustrates a method (1000) for providing external counter pulsation according to the present invention. The method according to the present invention may be provided to treat diseases such as stroke, dementia, and arteriosclerosis, but may also generally be provided simply to improve blood flow. As shown in FIG. 10, at step 1100, the method according to the present invention is triggered to start. In one embodiment, step 1100 may be manually triggered by a person, such as a user, via an interactive display (250). In another embodiment, step 1100 may be automatically triggered by a signal from a heart rate sensor (220, 230, 240). Next, in step 1105, the ECP processor (210) reads and analyzes various biometric information, such as data input by the user via a display, as well as, as non-limiting examples, an ECG (220), PPG (230), and a continuous blood pressure sensor (240), to determine the R peak of the user's heart rate. Once the R peak has been determined in step 1105 using various methods well known to those skilled in the art, the ECP processor (210) introduces a delay period from the R peak in step 1110 of about 10 ms to about 250 ms, about 50 ms to about 200 ms, or about 100 ms to about 150 ms. During the delay period, in step 1115, a decision is made as to whether additional air is required in the valve and fluid system (300). In one embodiment, step 1115 is performed by an ECP processor (210) based on air pressure signals from a converter (360a, 360b) that provides air pressure information for each of the air compartments (320, 340).If, at step 1115, it is determined that no additional air is needed in either of the air chambers (320, 340), for example, if the pressure within the air chambers (320, 340) is maintained at about 150 mmHg to 350 mmHg, 200 mmHg to about 300 mmHg, or about 250 mmHg, no additional air is needed, and at step 1120, the ECP processor (210) operates valve (310b) to connect the auxiliary air bag (170) to the air chamber (320) and pressurize the auxiliary air bag (170). Also, at step 1220, the ECP processor (210) operates valve (310a) to connect the spiral air bag (110) to the air chamber (320) in order to pressurize the spiral air bag (110) using air from the air chamber (320). In one embodiment, step 1120 is performed before step 1220, in which case a delay period of about 30 to 70 ms, or about 40 to 60 ms, or about 50 ms is introduced between step 1120 and step 1220.

[0034] At step 1125, the end of the auxiliary air bag (170) pressurization period is reached. In one embodiment, the pressurization period is about 200 ms to 600 ms, 250 ms to 550 ms, 300 ms to 500 ms, or about 400 ms. In one embodiment, the pressurization period may be determined based on the heart rate according to the table below.

[0035] Table 1

[0036]

[0037] In one embodiment, the ECP processor (210) performs step 1125 by recording this period. Next, in step 1130, the auxiliary air bag (170) is depressurized. In one embodiment, the depressurization is performed by the ECP processor (210) which signals the valve (310b) to connect the air bag (170) to the airway (380) by closing the air inlet valve (370) so that the air compressor (350) can generate negative pressure in the airway (380) to facilitate rapid depressurization of the auxiliary air bag (170), and by separating the air bag (170) from the air compartment (320). Next, in step 1135, the end of the depressurization period of the auxiliary air bag (170) is reached. In one embodiment, the ECP processor (210) performs step 1135 by recording this period. At step 1140, the decompression process of the auxiliary air bag (170) is stopped, and if the therapeutic effect is not fully realized, the process is repeated from step 1105.

[0038] Likewise, after maintaining the air pressure of the spiral air bag (110) for a preset period, the spiral cuff (105) pressurization period ends in step 1225. In one embodiment, the pressurization period is about 200 ms to 600 ms, 250 ms to 550 ms, 300 ms to 500 ms, or about 400 ms. In another embodiment, the air pressure of the spiral air bag (110) is maintained according to the user's heart rate according to Table 1, excluding the delay period introduced between the above-mentioned steps 1120 and 1220. In one embodiment, the ECP processor (210) performs step 1225 by recording this period. In step 1230, the spiral air bag (110) is depressurized. In one embodiment, the depressurization is performed by an ECP processor (210) that signals a valve (310a) to connect the spiral air bag (110) to an airway (38) where negative pressure is generated to depressurize the air bag by closing the air inlet valve (370) while the compressor (350) is operating, thereby separating the spiral air bag (110) from the air chamber (320). Next, at step 1235, the end of the spiral air bag (110) depressurization period is reached. In one embodiment, the ECP processor (210) performs step 1235 by recording this period. At step 1240, the depressurization process of the spiral air bag (110) is stopped, and the process is repeated from step 1105.

[0039] In one embodiment, steps 1125 and 1225 are performed at approximately the same time, and steps 1130 and 1230 are also performed at approximately the same time, so that both air bags (110, 170) are depressurized at approximately the same time. In another embodiment, step 1125 is performed before step 1225, and step 1130 is performed before step 1230, so that the auxiliary air bag (170) is depressurized before the spiral air bag (110). In this embodiment, the delay period is about 20 ms to 100 ms, 30 ms to 90 ms, 40 ms to 80 ms, or about 60 ms. In another embodiment, step 1125 is performed after step 1225, and step 1130 is performed after step 1230, so that the auxiliary air bag (170) is depressurized after the spiral air bag (110). In this embodiment, the delay period is about 20ms to 100ms, 30ms to 90ms, 40ms to 80ms, or about 60ms.

[0040] If, at step 1115, the ECP processor (210) determines that air replenishment is required in the air chambers (320, 340), steps 1120 through 1140 and steps 1220 through 1240 are performed as described above, but steps 1305 through 1315 are also performed to add more air to the system. Specifically, at step 1305, the ECP processor (210) signals the valve (370) to open the air inlet (375) and causes the compressor (350) to operate to replenish air in the air chamber (340). Consequently, the air pressure ratio regulating valve (330) adds air to the air chamber (320). At step 1310, when the system reaches the end of the air replenishment period, in one embodiment, the ECP processor (210) records the air replenishment period at step 1310. In step 1315, the ECP processor (210) signals the air inlet valve (370) to close in order to stop adding air to the valve system. In one embodiment, because the valve (370) must be closed so that negative pressure can be generated in the airway (380) during the air bag decompression period, steps 1305 through 1315 are performed simultaneously with steps 1120 through 1125 and steps 1220 through 1125, either before steps 1120 and 1220 or after steps 1140 and 1240 are completed.

[0041] FIG. 11 illustrates the method (1000) of the present invention. As shown in FIG. 11, an R peak is detected in step 1105 before the auxiliary air bag (170) is pressurized in step 1120, and a delay period of about 10 ms to about 250 ms, about 50 ms to about 200 ms, or about 100 ms to about 150 ms is introduced in step 1110. After the auxiliary air bag (170) is pressurized, the spiral air bag (110) is subsequently pressurized in step 1220 after a delay of about 50 ms. As shown in FIG. 11, if it is determined in step 1115 that air replenishment is necessary, air replenishment is performed for about 50 ms to about 100 ms almost simultaneously with the start of pressurization of the auxiliary air bag (170) in steps 1305 to 1315. Subsequently, in steps 1125 to 1140 and steps 1225 to 1240, both the auxiliary air bag (170) and the spiral air bag (110) are depressurized almost simultaneously.

[0042] FIG. 12 illustrates the therapeutic effect of the ECP device (10) of the present invention. As can be seen in FIG. 12a, the user's PPG signal is weak before treatment. During treatment, the user's PPG signal is maintained at a much more regular and constant intensity, as shown in FIG. 12b.

[0043] It should be understood that the general description above and the following detailed description are merely illustrative and descriptive and do not limit the invention as claimed in the claims.

[0044] These and other modifications may be made to the above technology in consideration of the detailed description. In general, terms used in the following disclosures should not be interpreted as limiting the technology to the specific embodiments disclosed herein, unless the above detailed description explicitly defines such terms. Accordingly, the actual scope of the technology includes the disclosed embodiments and all equivalent ways of practicing or implementing the technology.

Claims

Claim 1 An extracorporeal counterpulsation (ECP) device comprising: a. an air sac system including one or more spiral air sacs and one or more auxiliary air sacs, wherein each spiral air sac is shaped to form a spiral around the thigh that closely follows the major arteries and / or veins surrounding the femur when the spiral air sac is pressurized to affect the regulation of blood flow within the major arteries and veins surrounding the femur when attached to the user's thigh; b. a valve and fluid system pneumatically connected to the air sac system and configured to pressurize / depressurize the spiral air sacs and the auxiliary air sacs; and c. An extracorporeal counterpulsation (ECP) device characterized by comprising: a control system including a processor, one or more PPG sensors and one or more ECG sensors, wherein the PPG sensors and the ECG sensors are connected to a user to collect PPG signals and ECG signals from a user, and the control system is electronically connected to the valve and fluid system to control the valve and fluid system, thereby pressurizing or depressurizing the air bladder of the air bladder system based on signals detected by the sensors, and wherein the auxiliary air bladder is located at the lower or upper part of the spiral air bladder and is pressurized before the spiral air bladder to send blood flow in a desired direction. Claim 2 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the dimensions of the spiral air sac are determined by the user's anatomical structure so that the spiral air sac can closely follow the major arteries and veins of the user's thigh. Claim 3 An extracorporeal counterpulsation (ECP) device according to claim 1, wherein the length L (cm) of the spiral air bladder is determined as the user's height / 3.2-b, where b is 15 cm to 30 cm, the upper width and lower width of the spiral air bladder are each 14 cm, and the spiral angle is 55°. Claim 4 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the wattage of the valve system is less than 1500 watts. Claim 5 In paragraph 1, the spiral air pocket length L does not exceed 50 cm, W1 and W2 do not exceed 25 cm, and the area is 1250 cm² 2 An extracorporeal counterpulsation (ECP) device characterized by not exceeding Claim 6 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the pressure within the spiral air bag does not exceed 350 mmHg when fully pressurized. Claim 7 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the pressure of the spiral air bag is not lower than 150 mmHg when fully pressurized. Claim 8 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the ratio of the upper width W1 of the spiral air bag to the lower width W2 of the spiral air bag is 1:1 to 2:

1. Claim 9 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the spiral angle of the spiral air bag is 30° to 75°. Claim 10 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the auxiliary air bag is positioned at the lower end of the spiral air bag while the auxiliary air bag overlaps with the spiral air bag. Claim 11 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the auxiliary air bag is positioned at the lower end of the spiral air bag without overlapping with the spiral air bag. Claim 12 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the auxiliary air bag is positioned at the upper end of the spiral air bag while the auxiliary air bag overlaps with the spiral air bag. Claim 13 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the auxiliary air bag is positioned at the upper end of the spiral air bag without overlapping with the spiral air bag. Claim 14 An extracorporeal counterpulsation (ECP) device according to claim 1, characterized in that the auxiliary air bladder and the spiral air bladder are in a single cuff. Claim 15 delete

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