System and method for controlling blood pressure

Abstract

To provide a system and a method for controlling blood pressure.SOLUTION: A system for controlling blood pressure includes: a mounting-type interface having an inner contact surface, which is configured so as to surround a first part of a first limb of a subject at least partially; a sensing module supported by the mounting-type interface, which is configured so as to determine a change in the blood pressure of at least the first limb of the subject; and an energy application module supported by the mounting-type interface, which is configured so as to apply two or more types of energy to the first limb of the subject.SELECTED DRAWING: Figure 15

Description

Technical Field

[0001]

[0001] Embodiments of the present invention relate to a system and method for controlling the blood pressure of a living subject.

Summary of the Invention

[0002]

[0002] In a first embodiment of the present disclosure, a system for controlling blood pressure includes a wearable interface having an inner contact surface, the wearable interface being configured to at least partially surround a first portion of a first limb of a subject, a sensing module supported by the wearable interface and configured to determine at least a change in blood pressure of the first limb of the subject, and an energy application module supported by the wearable interface and configured to apply two or more types of energy to the first limb of the subject.

[0003]

[0003] In other embodiments of the present disclosure, a system for controlling blood pressure includes a wearable interface having an inner contact surface, the wearable interface being configured to at least partially surround a first portion of a limb of a subject, a sensing module supported by the wearable interface and configured to determine at least a change in blood pressure of the limb of the subject, the sensing module including at least one sensor for determining flow characteristics, and an energy application module supported by the wearable interface and configured to apply energy to the limb of the subject.

[0004]

[0004] In yet another embodiment of the present disclosure, a method for controlling a subject's blood pressure includes providing a system for controlling blood pressure, comprising: a wearable interface having an inner contact surface, the wearable interface being configured to at least partially surround a first portion of a subject's first limb; a sensing module supported by the wearable interface and configured to determine a change in blood pressure of at least the subject's first limb; and an energy application module supported by the wearable interface and configured to apply two or more types of energy to the subject's first limb; placing the system on the patient's arm; measuring blood pressure using the system; and applying energy to the subject's median nerve using the system.

[0005]

[0005] In yet another embodiment of the present disclosure, a method for controlling a subject's blood pressure includes providing a system for controlling blood pressure, comprising: a wearable interface having an inner contact surface, the wearable interface being configured to at least partially surround a first portion of a subject's first limb; a sensing module supported by the wearable interface and configured to determine a change in blood pressure of at least the subject's first limb; and an energy application module supported by the wearable interface and configured to apply two or more types of energy to the subject's first limb; placing the system on the patient's arm; measuring blood pressure using the system; and applying energy to the subject's radial nerve using the system.

[0006]

[0006] In yet another embodiment of the present disclosure, a method for controlling a subject's blood pressure includes providing a system for controlling blood pressure, comprising: a wearable interface having an inner contact surface, the wearable interface being configured to at least partially surround a first portion of a subject's first limb; a sensing module supported by the wearable interface and configured to determine a change in blood pressure of at least the subject's first limb; and an energy application module supported by the wearable interface and configured to apply two or more types of energy to the subject's first limb; placing the system on the patient's arm; measuring blood pressure using the system; and applying energy to the subject's ulnar nerve using the system. [Brief explanation of the drawing]

[0007] [Figure 1] This is a perspective view of a wearable blood pressure control system according to one embodiment of the present disclosure. [Figure 2] Figure 1 is a perspective view of the wearable blood pressure control system in a tightened, non-expanded state. [Figure 3] Figure 1 is a perspective view of a wearable blood pressure control system in a tightened and partially expanded state. [Figure 4] Figure 1 is a perspective view of the wearable blood pressure control system in a tightened and substantially expanded state. [Figure 5] Figure 1 is a perspective view of the wearable blood pressure control system used on the user's wrist. [Figure 6] Figure 1 is a perspective view of the wearable blood pressure control system during blood pressure measurement. [Figure 7] Figure 1 is a perspective view of the wearable blood pressure control system in operation, responding to detected changes in blood pressure. [Figure 8] This is a cross-sectional view of the wearable blood pressure control system shown in Figure 1, while in use on a user's wrist. [Figure 9] This is a perspective view of a wearable blood pressure control system according to one embodiment of the present disclosure. [Figure 10]Figure 9 is a plan view of the user interface of a wearable blood pressure control system. [Figure 11] This is a perspective view of a wearable blood pressure control system according to one embodiment of the present disclosure. [Figure 12] This is a perspective view of a wearable blood pressure control system according to one embodiment of the present disclosure. [Figure 13] Figure 12 is a perspective view of the wearable blood pressure control system in its separated state. [Figure 14] This is a flowchart illustrating methods for controlling a patient's blood pressure. [Figure 15] This is a perspective view of a wearable blood pressure control system in use on a user's wrist according to one embodiment of the present disclosure. [Figure 16] Figure 15 is an exploded view of a wearable blood pressure control system. [Figure 17] Figure 15 is a further exploded view of the wearable blood pressure control system. [Figure 18] Figure 15 is a bottom view of the wearable blood pressure control system. [Figure 19] Figure 15 is a perspective cutaway view of the sensing module of the wearable blood pressure control system. [Figure 20A] Figure 15 is a first exploded view of the pump and bladder assembly of the wearable blood pressure control system. [Figure 20B] Figure 15 is a second exploded view of the pump and bladder assembly of the wearable blood pressure control system. [Figure 21] Figure 15 is a plan view of the user interface of a wearable blood pressure control system. [Figure 22] This is a perspective view of a wearable blood pressure control system according to one embodiment of the present disclosure. [Figure 23] Figure 22 is a bottom view of the wearable blood pressure control system. [Figure 24] Figures 22 and 23 show the active element arrangement of a wearable blood pressure control system according to one embodiment of this disclosure. [Figure 25] This is a perspective view of the active element array shown in Figure 24 while it is in use on the user's wrist. [Figure 26]It is the active element array of the wearable blood pressure control system of FIGS. 22 and 23 according to an embodiment of the present disclosure. [Figure 27] It is a perspective view of the active element array of FIG. 26 in use on a user's wrist. [Figure 28] It is a cross-sectional view of the wearable blood control system of FIG. 22 along line 28-28. [Figure 29] It is a perspective view of the wearable blood pressure control system according to an embodiment of the present disclosure.

MODE FOR CARRYING OUT THE INVENTION

[0008]

[0037] Hypertension (high blood pressure) affects a large portion of the world's population, with an estimated 16% to 37% of the population being affected. Hypertension can be persistent or transient, but in either case, it is a major factor that generally increases morbidity and mortality both on its own and in combination with other diseases. Hypertension is thought to be responsible for approximately 18% of deaths worldwide. Hypertension is a concern in all parts of the world among most population subgroups. A reduction in mean blood pressure of a small amount (e.g., about 5 mmHg or more) can significantly reduce stroke or other cardiovascular events.

[0009]

[0038] According to several embodiments, simple wearable devices capable of sensing an increase in blood pressure and providing blood pressure-lowering treatment accordingly are described herein. Figure 1 shows a wearable blood pressure control system 10 configured to be placed on a patient's wrist. The wearable blood pressure control system 10 comprises a housing 12 and a band 14 coupled to the lower surface 16 of the housing 12. The wearable blood pressure control system 10 is shown in Figure 1 in an unfastened state. The band 14 is secured to the lower surface 16 of the housing 12 by epoxy or adhesive 18. In other embodiments, the band 14 may be secured by fasteners, sewing, fusion, or slide through a slit or elongated space within the housing 12. The band 14 is configured to wrap around the user / patient's wrist and fasten to itself by the use of a hook-and-loop (Velcro® type) system 20. An inner loop surface 20a of a portion of the band 14 fastens to an outer hook surface 20b of the band 14. The band may be offered in several different sizes (e.g., small, medium, large, or pediatric, adult) best suited for placement on patients of a particular size. The inflatable cuff 22 extends along a peripheral path 24 that surrounds the inside 26 of the band 14. In some embodiments, the band 14 may be configured to be worn like a watch or bracelet, and may also be configured to partially or completely surround a limb (e.g., arm) in part (e.g., wrist). The hook-and-loop system 20 may, in other embodiments, be replaced by a button closure, snap closure, adhesive closure, or magnetic closure.

[0010]

[0039] Figure 2 shows the wearable blood pressure control system 10 in a tightened state with the loop surface 20a fixed to the hook surface 20b. To better illustrate the operation of the inflatable cuff 22, the user's arm is not shown in Figures 2 through 4. A sensor 28 is supported on the inner surface 30 of the band 14 and measures heart rate and heart rate. Rhythm changeThe sensor is configured to sense one or more cardiovascular parameters, including motion, an electrocardiogram (ECG) including any measurable arrhythmia, or blood pressure. In some embodiments, the sensor 28 may include a pulse wave sensor. The pulse wave sensor may utilize CMOS (complementary metal oxide semiconductor) technology. In some embodiments, the sensor 28 may include an ultrasonic transducer. The ultrasonic transducer may include two or more piezoelectric elements. The ultrasonic transducer may be configured to operate as a Doppler transducer. In another embodiment, the sensor 28 may include one or more optical sensors for performing photoplethysmography (PPG). A controller 32 within the housing 12 is configured to receive signals from the sensor 28. The controller 32 may include a microcontroller. The controller 32 may be coupled to a transceiver 34 configured to wirelessly communicate with a mobile phone, smartphone, or other personal communication device including a chip embedded in or supported on part of the user's body or clothing. Thus, data monitoring and data analysis can be performed remotely. The controller 32 may be configured to analyze data from the sensor 28 to determine the presence of a medical condition including bradycardia, tachycardia, atrial arrhythmias such as atrial fibrillation or atrial flutter, or ventricular arrhythmias such as ventricular tachycardia. Identifying any of these phenomena involves heart rate, cardiac Rhythm change It may also be based on real-time analysis of motion or ECG amplitude. Sensor 28 may be able to sense two or more cardiovascular parameters. For example, sensor 28 may sense blood pressure and heart rate or blood pressure and heart rate. Rhythm change It may be configured to sense movement, or it may be configured to acquire an electrocardiogram and measure blood pressure. In some embodiments, the sensor 28 may comprise two or more sensors. In some embodiments, the two or more sensors may comprise a first sensor for measuring a first cardiovascular parameter and a second sensor for measuring a second cardiovascular parameter different from the first cardiovascular parameter.

[0011]

[0040] heart Rhythm change Dynamic changes, for example, heart Rhythm changeA decrease in dynamic blood pressure has been found to have some predictive ability regarding mortality after myocardial infarction. More continuous, or even sequential, measurement of blood pressure using sensor 28 allows us to be aware of how the heart responds to the ever-changing environment. Rather than focusing on a simple decrease in mean (e.g., median) blood pressure values, obtaining hourly, daily controlled blood pressure values ​​over time may provide more protection against heart disease. These data may be used to help physicians make more informed decisions regarding the treatment of hypertension and the overall treatment of the heart. The wearable blood pressure control system 10 is configured to monitor blood pressure throughout the day with various activities (eating, drinking, dieting, fasting, exercise, sleeping, walking, standing). The data obtained by sensor 28 may be used intelligently to apply treatment based on specific or tailored patient needs, and may also be guided by stored information regarding the optimal time to apply treatment.

[0012]

[0041] The inflatable cuff 22 may operate as a blood pressure cuff configured to determine the user's blood pressure. The transceiver 34 may include a Wi-Fi antenna. An actuator 36 coupled to the controller 32 is configured to receive a signal from the controller 32 and inflate the inflatable cuff 22. The actuator 36 may include a pneumatic pump configured to increase the air pressure within the inflatable cuff 22. In Figure 2, the inflatable cuff 22 is shown in a substantially uninflated state. In Figure 3, the inflatable cuff 22 is shown in a partially inflated state. In Figure 4, the inflatable cuff 22 is shown in a substantially inflated state. The inflatable cuff 22 may also be inflated by the controller 32 via the actuator 36 to apply therapeutic compression to the patient's wrist. In the first embodiment, a sensor 28 is configured to sense blood pressure and the inflatable cuff 22 is configured to apply therapeutic compression. In a second embodiment, the sensor 28 is configured to sense at least one parameter related to blood pressure, and the inflatable cuff 22 is configured to sense at least one parameter related to blood pressure and to apply therapeutic compression. In a third embodiment, the inflatable cuff 22 is configured to sense blood pressure and to apply therapeutic compression, and the sensor 28 is configured to sense one or more cardiovascular parameters other than blood pressure. In a fourth embodiment, the sensor 28 is configured to sense at least one parameter related to blood pressure, the inflatable cuff 22 is configured to sense at least one parameter related to blood pressure, and several other elements (not shown) are configured to apply treatment to lower blood pressure.

[0013]

[0042] In Figure 5, the wearable blood pressure control system 10 is used in a suitable location on the wrist 38 of the user's arm 40. The band 14 may be fixed immediately adjacent to the user's hand 44, or it may be attached around the wrist 38 (or other part of the arm 40) at a distance d from the hand 44, for example, 0.5 cm, 1 cm, 2 cm, 5 cm, 10 cm, or 15 cm, or at any distance between 0 cm and 15 cm.

[0014]

[0043] Referring to Figure 8, the wearable blood pressure control system 10 is shown coupled to the arm 40 of a user 42. Anatomical elements such as the radius 49, ulna 51, radial artery 45, and ulnar artery 47 are shown in relation to the band 14 and housing 12. The positioning of the wearable blood pressure control system 10 on the arm 40 in Figure 8 is one of many possible options. The wearable blood pressure control system 10 may be oriented differently (e.g., circumferentially / rotationally and / or longitudinally / axially) if different juxtapositions between the sensor 28 and one or more of the arteries 45, 47 or between the inflatable cuff 22 and one or more of the arteries 45, 47 are desired. The interior 53 of the inflatable cuff 22 is inflated by air pressurized by the actuator 36, and the air can freely enter (or exit) the housing 12 through the vent 55. The air is pushed into the inflatable cuff 22 by the actuator 36 through an access conduit 57 having a valve 59. The valve 59 is configured to maintain the air pressure inside the inflatable cuff 22 53. The actuator 36 and / or the valve 59 are also configured to allow air to exit through the valve 59 when it is desired to reduce the air pressure inside the inflatable cuff 22 53.

[0015]

[0044] In Figure 6, the sensor 28 senses the user's blood pressure 46 during use. The blood pressure 46 may be measured continuously or in a series of samples. The blood pressure 46 may be treated as systolic pressure relative to diastolic pressure, or as mean arterial pressure (MAP). The sensor 28 outputs a signal 48 proportional to the blood pressure 46 received by the controller 32. In Figure 7, the controller 32 instructs the actuator 36 to inflate the inflatable cuff 22. In embodiments where the inflatable cuff 22 is configured to be used as a blood pressure cuff, the controller 32 sets an initial pressure P above the expected maximum systolic arterial pressure where the internal 53 (Figure 8) is above the expected maximum systolic arterial pressure. sThe actuator 36 controls the inflation of the inflatable cuff 22 so that it is pressurized to a certain pressure P. The controller 32 then commands the actuator 36 and / or valve 59 to allow the release of air from the interior 53 at a specific rate, thereby lowering the pressure in the interior 53 to a pressure P below the expected minimum arterial diastolic pressure. f The pressure is reduced over a period T. Oscillometric sensing (e.g., by sensor 28) of occlusion of one or more arteries and subsequent release can also be used to determine the actual systolic and diastolic pressures, and these data can be used to control the pressurization and depressurization of the inflatable cuff 22 (e.g., via controller 32).

[0016]

[0045] In embodiments where the inflatable cuff 22 is configured to be used as a therapeutic compression element, the controller 32 controls the inflation of the inflatable cuff 22 by the actuator 36 so that the interior 53 is pressurized to a desired therapeutic inflation pressure Pt. The therapeutic compression applied to the arm 40 by the inflatable cuff 22 may be directed to stress the median nerve 43 (Figure 8). Stimulation of the median nerve by the application of energy such as compression may help lower blood pressure via known neural pathways, which may include the central nervous system (CNS). In some cases, a reduction in blood pressure may be achieved by downregulating sympathetic outflow. In some embodiments, the inflatable cuff 22 may be configured to be used both as a blood pressure cuff and as a therapeutic compression element.

[0017]

[0046] Figure 9 shows a wearable blood pressure control system 100 configured to be placed on a patient's wrist. The wearable blood pressure control system 100 comprises a housing 102 and a band 104 coupled to the lower surface 105 of the housing 102. In Figure 9, the wearable blood pressure control system 100 is shown in a tightened state to better illustrate its features, but the arm 40 is not visible. A loop 106 is secured to a first portion 108 of the band 104, and a series of rubber wedges 110 are supported by a second portion 112 of the band 104. To attach the wearable blood pressure control system 100 to the user's wrist 38, the user 42 (or a person assisting the user 42) slides the first end 114 of the band 104 through the opening 116 of the loop 106 and, while applying traction to the first end 114, pulls one or more of the wedges 110 through the opening 116 of the loop 106 until the band 104 is comfortably snug around the user's wrist 38. The flat edge 118 of one of the wedges 110a abuts against the edge 120 of the loop 106, thereby locking the wedge in place. To remove the band 104, the band 104 is pushed in the opposite direction, thereby temporarily (elastically) deforming the wedges 110 (or the loop 106) when pulled through the opening 116 of the loop 106 and / or the loop 106 is temporarily (elastically) deformed. Alternatively, a hook-and-loop system 20, such as the hook-and-loop system of the wearable blood pressure control system 10 in Figure 1, may be used. The wearable blood pressure control system 100 also includes a user interface 101 on the visible surface 103 of the housing 102.

[0018]

[0047] The wearable blood pressure control system 100 includes a cuff 122 that extends circumferentially within the band 104 between the second end 124 and the first portion 108 of the band 104. The cuff 122 is secured to the band 104 along a first edge 126 and a second edge 128, each edge extending circumferentially across the inner circumference of the band 104. The cuff 122 may be secured to the band 104 at the first edge 126 and the second edge 128 by adhesive, epoxy, or hot melt, or it may be sutured, stapled, or secured using other fastening means. As its name suggests, the cuff 122 corresponds to the outer layer, but is the inner portion of the circle when attached. As shown in Figure 9, the cuff 122 is configured to have an inflatable internal space 130.

[0019]

[0048] The cuff 122 supports a pair of sensing elements 132, 134 and a pair of vibrating elements 136, 138. The vibrating elements 136, 138 may comprise piezoelectric crystals, or they may comprise quartz, artificial quartz, or PZT (lead zirconate titanate) ceramic. The vibrating elements 136, 138 may be configured to vibrate at ultrasonic frequencies of approximately 20 kHz to approximately 1 MHz, or approximately 20 kHz to approximately 700 kHz, or approximately 20 kHz to approximately 500 kHz, or approximately 25 kHz to approximately 500 kHz, or approximately 30 kHz to approximately 200 kHz, or approximately 100 kHz to approximately 300 kHz. Frequencies of approximately 20 kHz to approximately 700 kHz may be very effective in stimulating nerves such as the median nerve 43 or the radial or ulnar nerve of the arm 40. Ultrasound can help stimulate several physiological processes that can help lower blood pressure. The application of ultrasonic energy can dilate blood vessels such as arteries, and thus improve blood flow. Sensational feedback signals the brain to modify other physiological functions to further lower blood pressure. Therefore, the vibrating elements 136, 138 may be configured to stimulate the median nerve 43 by vibration, provided they are made of appropriate material and have appropriate thickness to vibrate at one or more frequencies in the range of 20–700 kHz. The vibration applied to the median nerve 43 is sensed in the user's brain, and accordingly, blood pressure is reduced as part of a physiological feedback loop. Thus, the brain is "tricked" to play a more complex intervening role. In some embodiments, to induce multiple types of effects, one vibrating element 136 may be configured to vibrate within a lower frequency range (e.g., 20 kHz–100 kHz), while the other vibrating element 138 may be configured to vibrate within a higher (ultrasonic) frequency range (e.g., 100 kHz–700 kHz). In other embodiments, two or more vibrating elements 136, 138 may be configured to vibrate within a lower frequency range, while two or more additional vibrating elements 136, 138 may be configured to vibrate within a higher frequency range. In some embodiments, one or more vibrating elements 136, 138 may be configured to vibrate at multiple frequencies, such as a fundamental frequency (or a first harmonic) and a second harmonic.For example, in certain embodiments, the first harmonic may be 150 kHz, and the second harmonic may be 300 kHz. In other embodiments, a third harmonic, or even a fourth, fifth, or higher harmonic, may be used, as represented by the harmonic sequence. One particular treatment protocol may include a first activation period of the vibrating elements 136, 138, which is initiated immediately after the sensing elements 132, 134 detect a change in blood pressure (e.g., an increase). This first activation period may be followed by pressurization of the cuff 122. In relation to the wearable blood pressure control system 10 of Figures 1 to 8, further embodiments may add vibrating elements 136, 138. A particular treatment protocol associated with this other embodiment may include a first activation period of the vibrating elements 136, 138, which is initiated immediately after the sensor 28 detects a change in blood pressure (e.g., an increase). This first activation period may be followed by increasing pressurization of the inflatable cuff 22. The median nerve 43 is often the target, but in other cases, the effect may be concentrated on or shared with the radial or ulnar nerve.

[0020]

[0049] Returning to Figure 9, in some embodiments, the sensing elements 132, 134 and the vibration elements 136, 138 may be replaced with multipurpose elements configured to perform both the sensing function of the sensing elements 132, 134 and the energy application function of the vibration elements 136, 138.

[0021]

[0050] One or more of the sensing elements 132, 134 or the vibrating elements 136, 138 may be supported on the outer surface 140 of the cuff 122, or on the inner surface 142 of the cuff 122, or a combination thereof. The cuff 122 is configured to keep the sensing elements 132, 134 and the vibrating elements 136, 138 in close proximity to the user 42's wrist 38 (or any other part of the limb to which the band 104 is attached). For optimal acoustic coupling between the user 42's skin and the sensing elements 132, 134 or the vibrating elements 136, 138, it may be desirable to cover the wrist 38 with an acoustic coupling gel or other acoustic coupling medium. The sensing elements 132, 134 and the vibrating elements 136, 138 can be fixed to the outer surface 140 and / or inner surface 142 of the cuff 122 by epoxy or adhesive 144 having appropriate transition acoustic impedance characteristics. The wearable blood pressure control system 100 also includes a controller 151 and a connection port 191, which will be described in more detail in subsequent embodiments herein.

[0022]

[0051] Figure 10 shows a user interface 101 including a power switch 109 configured to turn the wearable blood pressure control system 100 on or off. The user interface 101 may include a touchscreen and may utilize capacitive or resistive touch sensitivity. Alternatively, mechanical or membrane buttons / switches may be used. A first controller 111 having a first button 113 and a second button 115 is configured to manually adjust the vibration mode. In other words, the vibration elements 136, 138 may be manually set (e.g., to low (intensity), medium, or high vibration) using the first button 113 and / or the second button 115. One of the buttons 113, 115 may increase the intensity of the vibration, while the other button 113, 115 may decrease the intensity of the vibration. Alternatively, an application (app) 153 in a mobile phone or device 155 may be configured to receive one or more signals 157 from the sensing elements 132, 134 (via software or firmware) and to automatically adjust the vibration mode to turn the vibration mode on or off, or to adjust the vibration mode between low, medium, and high vibration levels. In some embodiments, the vibration mode may be automatically adjustable by servo control or other means, so that the vibration elements 136, 138 are operated in a manner that is proportional to or in some way matches the decrease or increase in the amplitude, intensity, and / or spread of the blood pressure change. For example, the vibration elements 136, 138 may be configured to operate in a derivative of the blood pressure rise measured or calculated by the sensing elements 132, 134 (or by the cuff 122 if used as a blood pressure cuff).

[0023]

[0052] A second controller 117, having a first button 119 and a second button 121, is configured to manually adjust the compression mode. The inflation of the internal space 130 of the cuff 122 may be manually set (for example, to low inflation, medium inflation, or high inflation) using the first button 119 and / or the second button 121. One of the buttons 119, 121 may increase the inflation pressure or injection volume, while the other button 119, 121 may decrease the inflation pressure or injection volume. Alternatively, a controller 151 and / or app 153 in the housing 102 may be configured to receive one or more signals from sensing elements 132, 134 (via software or firmware) and automatically adjust the compression mode to turn the compression mode on or off or to adjust the compression mode between low, medium, and high compression.

[0024]

[0053] Figure 11 shows a wearable blood pressure control system 250, similar to the wearable blood pressure control system 100 of Figure 9, but further comprising stimulating electrodes 252, 254, and 256 supported on the outer surface 140 of the cuff 122. The user interface 101 and / or app 153 may be configured to adjust or program the controller 251 so that one or more potentials (voltages) are applied between two or more of the electrodes by a current flowing through wiring or traces 258, 260, and 262 electrically coupled to the electrodes 252, 254, and 256, based on a signal received from one or more signals from the sensing elements 132, 134. The current may be applied using voltage control. Alternatively, the current may be applied using current control. The applied current can, for example, activate nerves such as the median nerve 43 to provide additional input to the patient's brain. The user interface 101 (Figure 10) may include a third mode, which is an electrical stimulation mode that can be adjusted manually or using feedback from the sensing elements 132, 134. Any combination of two or three (or more) modes can be assumed, or in some embodiments, only a single mode may be assumed. Electrodes 252, 254, and 256 may be configured to stimulate the median nerve 43 by directing one or more applied potentials toward the median nerve, thereby altering or inducing control or modification of cerebral blood pressure. In another embodiment, electrodes 252, 254, and 256 may be configured to sense physiological signals related to changes in blood pressure or other cardiovascular parameters.

[0025]

[0054] The controller 251 may be configured, or programmable to be configured, to function as a programmable pulse generator by applying, via hardware, firmware, or software, one or more of the following: inflation of the cuff 122, activation of electrodes 252, 254, 256, or activation of vibration elements 136, 138, with a specific range of set parameters or a range of set parameters. For example, in a particular embodiment, the voltage, current, frequency, or pulse width of the activation of electrodes 252, 254, 256 may be controlled within the following ranges: Current: 0.1 mA to 200 mA or 0.1 mA to 50 mA; Applied frequency / rate: 0.1 mA to 200 mA or 1 Hz to 5,000 Hz or 1 Hz to 1,000 Hz or 1 Hz to 200 Hz; Pulse width: 0.01 microseconds (μs) to 1,000 microseconds (μs) or 1 microseconds (μs) to 1,000 microseconds (μs) or 0.01 microseconds (μs) to 5 microseconds (μs). The controller 251 may activate the electrodes in continuous mode or in random mode including one or more bursts. The on-time and off-time of the bursts may be controlled independently. The on-time and off-time may be varied using a specific program or algorithm. In another embodiment, the controller 251 may be configured, or programmable to be configured, via hardware, firmware, or software to apply at least one or more of the following in a partially random or pseudo-random manner: inflation of the cuff 122, activation of electrodes 252, 254, 256, or activation of vibration elements 136, 138. The human body is adaptable, and many physiological systems tend to adapt to therapeutic procedures in a manner that sometimes appears beneficial to the body, even when it actually antagonizes the therapeutic purpose or effect. The nervous system can change continuously through processes such as synaptic adaptation.Random changes to the way therapeutic elements (cuff 122, vibration elements 136, 138, electrodes 252, 254, 256) are applied can serve as a way to preempt or "deceive" the body's adaptive scheme, which otherwise would be found to be counteracting efforts to actually control blood pressure. Parameters that can be randomly or non-randomly adjusted by the controller 251 include the application time of energy (mechanical, electrical, etc.), the length of the time interval between energy applications, the number of energy applications, the specific operating frequency of energy in non-static modes (e.g., applying ultrasound at various pulse rates), the amplitude of applied energy, and the timing of specific types of energy or specific combinations of multiple elements of two or more different types of energy. Any of these parameters can be increased or decreased. The controller 251 may be configured to allow the user / patient to control some or all of these parameter adjustments, for example, via the user interface 101 and / or app 153. In addition, in some embodiments, there may be security levels to control how much control the user has, i.e., a first level for the user and a second level for the prescribing physician. In some embodiments, the existence of controls unavailable to the user but available to the physician may ensure a certain degree of randomness in treatment. This may, in some cases, be necessary for certain patients who do not want to be startled by, for example, compression, electrode activation, or vibration events. Security levels may include encryption or password control. The “smart” nature of either the wearable blood pressure control system 250 or any other system described in the embodiments herein allows the system to be managed by a primary care physician and therefore does not require a specialist. Also, since the device does not require surgery or invasive procedures, only one healthcare person / place needs to be involved in the patient's care.

[0026]

[0055] Figure 12 shows a wearable blood pressure control system 300 having multimode energy delivery therapy including both vibration and electrical stimulation. The wearable blood pressure control system 300 is similar to the wearable blood pressure control system 100 of Figure 9, but does not include compression and includes stimulating electrodes 302, 304, and 306 supported on the limb-facing surface 308 of the band 310. The band 310 has a first end 330 and a second end 332 and is detachably attached to a detachable / replaceable housing 336. A loop 334 is fixed to the band 310 and has an opening width W1. The insertion portion 340 of the band 310 has a thickness W2 that is smaller than the opening width W1. The vertical wall 338 of the band 310 has a thickness W3 that is slightly larger than the opening width W1, thus resulting in a friction fit that eliminates the need for a wedge 110 or hook / loop 20a / 20b. During use, the user inserts the insertion portion 340 into the loop 334 and pulls the band 310 from the first end 330 until it is adjusted to the wearer's limb. Friction between the vertical wall 338 and the loop 334 keeps the band 310 in place. The user interface 312 and / or app 153 may be configured to adjust or program the controller 314 so that one or more potentials (voltages) are applied between two or more of the electrodes by current flowing through wiring or traces 320, 322, 324 electrically coupled to the electrodes 302, 304, 306 by signals sent by the controller in response to one or more signals from the sensing elements 316, 318. The current may be applied using voltage control. Alternatively, the current may be applied using current control. The applied current can provide additional input to the brain that can activate nerves, such as the median nerve 43, and help lower blood pressure. The user interface 312 includes a vibration mode 311 and a stimulation mode 313 (via electrodes), each of which can be adjusted manually or automatically using feedback from sensing elements 316, 318. Any combination of the two modes can be assumed to form a mixed signal. The mixed signal may include a cycle having a first period of only one of the vibration or stimulation and a second period of the other of the vibration or stimulation. The mixed signal may include at least one period in which the vibration and stimulation occur simultaneously.Electrodes 302, 304, and 306 may be configured to stimulate the median nerve 43 by directing one or more applied potentials toward the median nerve to alter or induce (e.g., lower blood pressure) the control or modification of cerebral blood pressure. In another embodiment, electrodes 302, 304, and 306 may be configured to sense physiological signals related to changes in blood pressure or other cardiovascular parameters. A combination of synchronized vibration and electrical stimulation can produce tuned and optimal results for continuous blood pressure, heart rate, and cardiac function. Rhythm change Further information can be provided by measuring cardiovascular parameters such as ECG, including the detection of movement or specific cardiac arrhythmias.

[0027]

[0056] The controller 314 may be configured, or programmable to be configured, to function as a programmable pulse generator by applying, via hardware, firmware, or software, one or more of the operation of electrodes 302, 304, 306 or the operation of vibration elements 326, 328, with a specific range of set parameters or a range of set parameters. For example, in certain embodiments, the voltage, current, frequency, or pulse width of the operation of electrodes 302, 304, 306 may be controlled within the following ranges: Current: 0.1mA to 200mA or 0.1mA to 50mA; Frequency / rate of application: 0.01Hz to 50kHz or 1Hz to 5,000Hz or 1Hz to 1,000Hz or 1Hz to 200Hz; Pulse width: 1 microsecond (μs) to 1,000 milliseconds (μs) or 1 microsecond (μs) to 1,000 microseconds (μs) or 0.01 milliseconds (ms) to 5 milliseconds (ms). The controller 314 may activate the electrodes in continuous mode or in random mode including one or more bursts. Activation may include a specific start time, a specific end time, and / or a specific duration. The operating period of electrodes 302, 304, and 306 may include one or more of the following patterns: biphasic sine wave, polyphasic wave, monophasic sine wave, biphasic pulsating sine wave, biphasic square wave, monophasic square wave, monophasic pulsed square wave, biphasic spike wave, monophasic spike wave, and monophasic pulsed spike wave. The on-time and off-time of a burst may be controlled independently. The on-time and off-time may be varied using a specific program or algorithm. In another embodiment, the controller 314 may be configured, or programmable to be configured, via hardware, firmware, or software to apply at least one or more of the activation of electrodes 302, 304, 306 or the activation of vibration elements 326, 328 in a partially random or pseudo-random manner, as described in relation to the embodiment of Figure 11. Any one of electrodes 302, 304, 306 may function as a patient return electrode, thus eliminating the need for an additional skin-placed return electrode patch.Therefore, by simply attaching the band 310 to the wearer / user's limb, the wearer / user can immediately begin using the wearable blood pressure control system 300.

[0028]

[0057] Multiple touchpoints are provided by electrodes 302, 304, 306 and vibrating elements 326, 328, and these touchpoints are positioned at different clock positions around the limb-facing surface 308 of the band 310, thereby increasing the likelihood that the optimal anatomical position for effective treatment will be identified and treated, resulting in a higher success rate. The controller 314 may be configured to allow the user / patient to control some or all of these parameter adjustments, for example, via a user interface 312 and / or app 153. In addition, in some embodiments, there may be security levels to control how much control the user has, i.e., a first level for the user and a second level for the prescribing physician. In some embodiments, the existence of controls unavailable to the user but available to the physician may ensure some degree of randomness in the treatment. This may, in some cases, be necessary for certain patients who do not want to be startled, for example, by electrode activation or vibration events. The security levels may include encryption or password control. Connection port 191 may be used to temporarily or permanently connect a USB cable, USB drive, or other cable or drive to transfer information, charge an internal battery, or supply power to any internal components. Many of the components described in the wearable blood pressure control system 300 have relatively low power requirements and are therefore suitable for a rechargeable battery system. Connection port 191 may also be used to connect a wireless antenna, if necessary, whether or not the wearable blood pressure control system 300 has internal wireless functionality. Communication may allow the wearable blood pressure control system 300 to be controlled by an application on a mobile device such as a mobile phone / smartphone. Data monitoring and analysis can also be performed remotely at one or more sites.

[0029]

[0058] The wearable blood pressure control system 300 may include adaptive capabilities. For example, the controller 314 may be programmed or pre-programmed to provide specific treatment plans, such as morning energy delivery, midday energy delivery, and evening energy delivery. However, by analyzing changes in one or more cardiovascular parameters measured by the sensing elements 316, 318, the controller 314 may be configured to modify the treatment plan to optimize the patient response. For example, the modification may include the application of vibrational energy with a larger amplitude and / or longer duration, and the application of electrical stimulation energy with a smaller amplitude and / or shorter duration. Alternatively, in other cases, the modification may include the application of electrical stimulation energy with a larger amplitude and / or longer duration, and the application of vibrational energy with a smaller amplitude and / or shorter duration. An energy modulation algorithm may be applied to enable the wearable blood pressure control system 300 to learn to better provide each wearer with custom neuromodulation management that can correspond to each patient's blood pressure or other cardiovascular parameters. Therefore, the wearable blood pressure control system 300 can learn from each patient's physiological function and therapeutic effect for personalized and optimized treatment. Each individual energy modality (application of electrical stimulation or vibration) can be optimized, as can combinations of multiple energy modalities. Heart rate or heart Rhythm change The heart rate intervals used in the calculation of rhythm may be derived from ECG data or blood pressure data. In some embodiments, the RR interval (from consecutive R points in the QRS complex of the ECG) is used. The RR interval is sometimes called the NN interval when referring to the RR interval in normal cardiac beatings, more specifically, in cardiac beatings that do not include beatings originating from the sinoatrial node. In some embodiments, time-domain methods may be used for the rhythm-related calculations. In other embodiments, geometrical methods may be used for the rhythm-related calculations. In other embodiments, frequency-domain methods may be used for the rhythm-related calculations.

[0030]

[0059] In Figure 13, the housing 336 is detached from the band 310. The housing 336 is detachable from and reattachable to the band 310 for several reasons. The housing 336 may include one or more rechargeable batteries that can be recharged by attaching a power cable to the connection port 191 or to other ports connected to the battery. The batteries may be rechargeable by wired or wireless methods, including inductively coupled charging. A wireless charging unit 345 may be used to charge the batteries. In another embodiment, one or more batteries may be primary batteries configured to be used and then discarded (or recycled). The housing 336 is secured to the band 310 via two magnets 346, 348 configured to attract magnets 350, 352 supported on the surface 344 of the band 310. In the embodiment of Figure 13, the magnet 348 has an outward-facing positive pole configured to magnetically engage with the magnet 350, which has an outward-facing negative pole. Magnet 346 has an outward-facing negative pole configured to magnetically engage with magnet 352, which has an outward-facing positive pole. The magnets may comprise rare earth magnets such as neodymium-iron-boron or samarium-cobalt. The neodymium-iron-boron magnet may be selected from grades of N30 or higher, or N33 or higher, or N35 or higher, or N38 or higher, or N40 or higher, or N42 or higher, or N45 or higher, or N48 or higher, or N50 or higher. In some embodiments, the neodymium-iron-boron magnet may have grades of N30-N52, N33-N50, or N35-N48. In some embodiments, one of the two magnets forming each attractive pair may be replaced with a magnetic material such as iron or 400 series stainless steel, which can be attracted by the poles of the opposing magnet.

[0031]

[0060] Electrical connections may be achieved by conductive projections 354 configured to electrically engage with conductive recesses 356 supported on the band 310 and on the bottom surface 342 of the housing 336. The conductive recesses 356 are electrically connected to various electrical components of the housing 336, which may include a user interface 312, a controller 314, and a connection port 191. The conductive projections 354 are electrically connected to traces 320, 322, 324 and stimulating electrodes 302, 304, 306, vibrating elements 326, 328, and sensing elements 316, 318 (Figure 12). Thus, when the housing 336 is attached to the band 310 via the attractive force of magnets 346, 348, 350, 352, the conductive projections 354 are electrically coupled to the conductive recesses 356. As a result, the user interface 312, controller 314, and connection port 191 are electrically interconnected with traces 320, 322, 324 and stimulating electrodes 302, 304, 306, vibration elements 326, 328, and sensing elements 316, 318. The user may choose to remove the housing 336 from the band 310 for reasons other than recharging. For example, if the first housing 336 is damaged or malfunctions, the first housing 336 may be replaced with a second housing 336. The housing 336 may be removed to provide information or software updates to a medical facility where they may be uploaded or downloaded, or for maintenance or repair. In Figure 13, the conductive protrusions 354 and conductive recesses 356 are shown between magnets 350, 352 or between magnets 346, 348, respectively. In other embodiments, the conductive protrusions 354 and / or conductive recesses 356 may be positioned laterally from magnets 350, 352 and / or magnets 346, 348. In some embodiments, the conductive protrusions 354 and conductive recesses 356 may be replaced, respectively, by a series of conductive terminals, each having both a protrusion and a recess, or by a series of terminals having a substantially flat arrangement of conductive terminals (without protrusions or recesses).

[0032]

[0061] In another embodiment, the magnets 346, 348, 350, and 352 may be replaced by other connections such as snaps, hook-and-loop (Velcro®), slide engagements, or adhesive strips.

[0033]

[0062] A method for controlling blood pressure in a subject is described in relation to Figure 14. In the first step 360, wearable blood pressure control systems 10, 100, 250, and 300 are prepared. In the second step 362, the wearable blood pressure control systems 10, 100, 250, and 300 are placed on the subject's arm. The wearable blood pressure control systems 10, 100, 250, and 300 may be placed close to the median nerve 43. In some cases, the wearable blood pressure control systems 10, 100, 250, and 300 may be placed close to the right median nerve on the right arm. In some cases, the wearable blood pressure control systems 10, 100, 250, and 300 may be placed close to the left median nerve on the left arm. In some cases, the first wearable blood pressure control system 10, 100, 250, 300 may be positioned on the right arm in close proximity to the right median nerve, and the second wearable blood pressure control system 10, 100, 250, 300 may be positioned on the left arm in close proximity to the left median nerve.

[0034]

[0063] In the third step 364, the wearable blood pressure control system 10, 100, 250, 300 measures the subject's blood pressure. In some cases, the blood pressure may be measured by a blood pressure cuff, and in other cases, by a blood pressure sensor. In some cases, the sensor and the blood pressure cuff may work together to measure the blood pressure. The measured blood pressure may be given or analyzed as systolic blood pressure relative to diastolic blood pressure, or in other cases, as mean arterial pressure (MAP). In the fourth step 366, if it is determined that the blood pressure is elevated, high, hypertensive, or exceeds a predetermined threshold, the wearable blood pressure control system 10, 100, 250, 300 applies energy to the median nerve in the arm on which it is worn. The applied energy may include compressive stress (pressure), electrical stimulation, vibrational stimulation, ultrasonic stimulation, thermal application, thermal removal (cooling), magnetic exposure, electromagnetic exposure, sound wave stimulation, or other mechanical energy application. In some cases, the application of energy to the median nerve may have a duration of approximately 5 minutes to 1 hour, or approximately 10 minutes to 45 minutes, or approximately 15 minutes to 35 minutes, or approximately 20 minutes to 30 minutes, or approximately 1 minute to 10 minutes, or approximately 5 minutes to 10 minutes. Combinations of energy application modalities (e.g., vibration and electrical stimulation) are effective in significantly reducing the time required to lower a patient's blood pressure. Once an increase in blood pressure is detected, combinations of energy application modalities can lower blood pressure in less than approximately 15 minutes or less than approximately 10 minutes, which is considerably faster than conventional single-energy modalities.

[0035]

[0064] The wearable blood pressure control systems 10, 100, 250, and 300 may be configured or programmable to perform step 364 (and step 366, if the system determines it is appropriate) at specific times during the day while the subject is wearing the wearable blood pressure control systems 10, 100, 250, and 300. For example, the step may be applied a) when the subject wakes up or gets out of bed, b) at a specific time in the morning (e.g., after a meal), c) at a specific time around noon (e.g., just before, during, or immediately after lunch), before bedtime, or at any other time in the evening. The wearable blood pressure control systems 10, 100, 250, and 300 may be configured or configurable to perform step 364 once, twice, three or more times per day. The wearable blood pressure control systems 10, 100, 250, and 300 may be configured or configurable to perform step 366 once, two, three or more times per day.

[0036]

[0065] Figure 15 shows a wearable blood pressure control system 400 having multimode energy delivery therapy including both vibration and electrical stimulation. The wearable blood pressure control system 400 includes the features of the wearable blood pressure control system 250 in Figure 11, the wearable blood pressure control system 300 in Figure 12, and the wearable blood pressure control system 100 in Figure 9, as well as other distinct features. The housing 402 is connected to the first band 404 by any of the embodiments described herein. The first band 404, having a first end 401 and a second end 403, includes an adjustable inner surface 406 configured to inflate so that the first band 404 can fit a wide range of limb sizes (e.g., arm circumference, wrist circumference, etc.). The first band 404 may be fastened to itself by a hook-and-loop system or any of the other modalities described herein in relation to other embodiments. The second band 408 is supported parallel to the first band 404 and is configured to position the sensing module and / or energy application module in close proximity to the limb. The sensing module receives blood pressure, electrocardiogram data, heart rate, or cardiac information from the limb. Rhythm changeIt may be configured to measure one or more cardiovascular parameters, including motion. The energy application module may be configured to deliver two or more types of energy to the limb, such as vibrational energy or electrical stimulation energy. A user interface 410 having a display 412 and a controller 414 is supported on the housing 402.

[0037]

[0066] The first band 404, shown in detail in Figure 16, comprises an inflatable bladder 416 sealed within the upper band 418 and the lower band 420. The bladder 416 may be made of a relatively high-strength flexible material such as polyurethane or polyethylene terephthalate (PET). The bladder 416 may comprise an upper sheet 405 and a lower sheet 407 sealed around an outer seal 409. The upper band 418 and the lower band 420 may comprise a fabric such as woven polyamide (nylon). The outer circumference 422 of the upper band 418 is sealed to the outer circumference 424 of the lower band 420, so that when the internal cavity 426 of the bladder 416 is inflated with air, the lower band 420 is pushed radially away from the upper band 418, except for circumferential seams 428, 430 (Figure 15). Therefore, the contact surface 432 of the lower band 420 functions as an adjustable inner surface 406 configured to contact the skin of the user's limb. The outer surfaces 422, 424 may be sealed to each other by hot melt adhesive, thermal bonding, or epoxy or adhesive. The bladder 416 includes an inlet port 434 for the inflow of an expansion fluid (e.g., air) and an outlet port 436 for the outflow of the expansion fluid. As shown in Figure 17, each of the ports 434, 436 has an outer diameter 438, an inner diameter 440, and tapered snap wings 442, 444. Returning to Figure 16, the ports 434, 436 extend through holes 446, 448 in the upper band 418, respectively, thereby making these ports accessible for mounting the housing 402 to the main housing 450. The bladder 416 is captured (e.g., sandwiched) between the upper band 418 and the lower band 420 without being coupled at the coupling region 454. Thus, the bladder is not excessively constrained to the upper band 418 or the lower band 420, and the outer surface of the bladder 416 can slide along the inner surfaces of the upper band 418 and the lower band 420 as the bladder 416 expands. In another embodiment, the bladder 416 includes an upper surface 452 having a coupling region 454 over at least its periphery 458 or a portion of its periphery 458, which is coupled to the lower surface 456 of the upper band 418.The bonding region 454 may be sealed to the lower surface 456 of the upper band 418 by hot melt adhesive, thermal bonding, or epoxy or adhesive.

[0038]

[0067] The mounting pin 460 has a distal end 462 that is attached to a hole 466 in the first end 470 of the second band 408, and a large-diameter proximal end 464 that is configured to snap into one of a series of holes 468 in the second end 472 of the second band 408. The second band 408 is fixed to the first band 404 along its lateral edge 474, as shown in Figure 18, so that when the first band 404 and the second band 408 are fixed around the limb, a series of active elements 476 are bonded in close proximity to the skin of the limb. The fixation of the second band 408 to the first band 404 may be by suturing, welding, overmolding, or thermal bonding. Returning to Figure 16, the active element 476 comprises four ceramic piezoelectric discs 478 (478a to 478d) and four electrodes 480 (480a to 480d). The piezoelectric disc 478 may be completely molded within the second band 408. The second band 408 may comprise a material, such as a silicone elastomer, that is acoustically coupled to the piezoelectric crystal of the piezoelectric disc 478. The electrode 480 is exposed at the contact surface 482 of the second band 408, as shown in Figure 18, so that when the second band 408 is fixed to the user's limb, the electrode can come into direct contact with the user's skin. To maximize bonding to the subject's skin, an acoustically coupled gel may be used on the contact surface 482 and on the electrode 480. Referring to Figure 19, the second band 404 is shown translucently, so that the active elements 476 are visible within their embedded array. Each piezoelectric disc 478a-478d has a conductive layer 484, which may be sputtered or coated by other forms of deposition. The first conductor 486 and the second conductor 488 are soldered to the conductive layer 484 at their first exposed ends 490, 492. The conductors 486, 488 may include outer insulating jackets 494, 496 along most of their length. The second exposed ends 498, 499 of the conductors 486, 488 are configured to be electrically coupled to the electronic components in the housing 402. Each electrode 480a-480d is soldered to the exposed end 497 of the conductor 495, which has an insulating jacket 493. The second exposed end 491 is configured to be electrically coupled to the electronic components in the housing 402.The side edge 474 of the second band 408 includes a plurality of snaps 489 configured to snap-engage and secure the insulating jackets 493, 494, 496 of the conductors 495, 486, 488 to the second band 408 and the first band 404 in place, and thus to hold those bands in place and provide tension relief.

[0039]

[0068] Returning to Figure 16, the main housing 450 includes a main circuit board 487 and a liquid crystal display (LCD) 485, which are covered by a glass cover 483. These components are housed within the main housing 450 by a cover 481, which is secured to the main housing by screws 479. The user interface 410 is bonded to the cover 481 by a molded adhesive layer 477. Operable buttons 475, 473, and 471 coupled to the main circuit board 487 are accessible via touch buttons 469, 467, and 465 of the user interface 410 and notches 463, 461 in the cover 481 and the adhesive layer 477, respectively. Figure 17 shows tactile switches 459, 457, and 455 that are activated by pressing the operable buttons 475, 473, and 471, respectively. In another embodiment, the user interface may include capacitive or resistive touch sensitivity. A diaphragm pump 453 is supported on an auxiliary circuit board 451 configured to control blood pressure measurement. The pump 453 may comprise a piezoelectric micropump. A spacer 449 is configured to separate the auxiliary circuit board 451 from the main circuit board 487 for space or cooling concerns, although the main circuit board 487 is electrically coupled to the auxiliary circuit board 451. Either the circuit boards 451 or 487 may be manufactured by printing or other mass manufacturing techniques. Power is supplied to the electronic components by a battery 447, similarly housed within a housing 402. In some embodiments, the battery comprises a rechargeable battery. In some embodiments, the battery comprises a lithium-ion 3.7-volt rechargeable battery. The main circuit board 487 is configured to transfer power and / or control to the auxiliary circuit board 451. The auxiliary circuit board 451 is configured to use a portion of this power to drive the pump 453. A microcontroller 419 is supported on the main circuit board 487, but may, alternatively, be supported on the auxiliary circuit board 451. The microcontroller 419 may be programmed or programmable to control the operation of any of the functions of the wearable blood pressure control system 400.The microcontroller 419 may control parameters such as start time, stop time, rise time, intensity, or any RAM timing parameters (memory timing parameters) such as column address strobe (CAS) wait time, row address delay relative to column address, pre-charge time, or row active time.

[0040]

[0069] Further electrodes 445 and 443 are supported in circular recesses 437 and 435 on the sides 441 and 439 of the main housing 450, respectively. They are also electrically coupled to one or both of the main circuit board 487 or the auxiliary circuit board 451. In some embodiments, one or both of the circuit boards 487 and 451 may be configured to receive input from one or more of the electrodes 480a to 480d and electrodes 445 and 443 in order to obtain electrocardiogram (ECG) data. During use, the subject places the wearable blood pressure control system 400 on the first limb, for example, by wrapping and securing the bands 404 and 408 around the subject's left wrist. The subject then initiates an ECG measurement via the user interface 410 and then touches one of the electrodes 445 and 443 on the main housing 450 with the fingers of the subject's right hand. Electrodes 480a–480d, 445 (or electrodes 480a–480d, 443, or other combinations) work together to create multiple ECG vectors to enable useful cardiovascular data. Incorporating both the left wrist and the right hand (via at least one finger) provides bilateral input, which is crucial for a reliable and physiologically indicative electrocardiogram (ECG). In some embodiments, finger contact with electrode 445 or electrode 443 automatically initiates ECG measurement without requiring the use of touch buttons 469, 467, 465 on the user interface 410. In some embodiments, the control circuit may be configured or programmed so that finger contact with one of electrodes 445, 443 starts and maintains ECG measurement, and removal of the finger stops ECG measurement.

[0041]

[0070] Figures 20A and 20B show the connection between the bladder 416 and the pump 453. The pump 453 includes an outlet port 371 fixed within an inner cylindrical cavity 375 in the main housing 450. An O-ring 369 supported around the outlet port 371 provides a seal between the pump 453 and the main housing 450, as the O-ring 369 seals the communication between the outlet port 371 and the cavity 375. An exhaust port 367, also having an O-ring 365 around it, seals into the inner cylindrical cavity 363 in the main housing 450. Thus, the air discharged from the bladder 416 escapes through the auxiliary circuit 451 and enters the interior of the housing 402. A solenoid 361 (Figure 17), supported on the auxiliary circuit 451, is controlled by a microcontroller 419 to open and close the solenoid 361 to keep air inside the bladder 416 or to allow air to escape from the bladder 416. The snap-engagement bracket 399 is secured to the lower surface 397 of the main housing 450 by inserting the tabs 395 and 393 of the snap-engagement bracket 399 into the slots 391 and 389 of the main housing 450, respectively, and then screwing (not shown) through the hole 387 of the snap-engagement bracket 399 into the screw hole 385 of the lower surface 397 of the main housing 450. The ports 434 and 436 of the bladder 416 snap-engage into the holes 383 and 381 of the snap-engagement bracket 399, respectively. The tapered snap wings 442 and 444 allow the introduction of the ports 434 and 436 into the holes 383 and 381, ensuring attachment of the snap-engagement bracket 399 to the main housing 450 (and therefore to the housing 402). In some embodiments, the tapering of the tapered snap wings 442 and 444 is only on the introduction side (as shown), so that the bladder 416 can be attached to the housing 402 but not to it. In other embodiments, the tapered snap wings 442, 444 may have a taper on the underside, so that the bladder 416 can be attached to and removed from the housing 402. Thus, the bladder 416 and the first band 404 may be configured to be disposable and replaceable in some embodiments.In these embodiments, the first band 404 and the second band 408 may be removably connected to each other, for example, by a snap, hook-and-loop, rib and groove configuration, or by adhesive attachment. When the ports 434 and 436 are snap-engaged through the holes 383 and 381, the tapered hubs 379 and 377, having extensions of the inner cavities 375 and 373, engage tightly with the inner diameter 440 of the ports 434 and 436. This completes the tightly sealed communication between the pump 453 and the bladder 416.

[0042]

[0071] The adjustable inner surface 406 of the first band 404 is configured to automatically inflate to the appropriate size (for example, by the bladder 416 being inflated by the pump 453 with a specific amount of air) so that it applies the appropriate amount of fit (radially applied pressure) to the limb at the attachment site. The microcontroller 419 may be programmed or programmable to initiate the bladder inflation cycle using feedback from any two of the electrodes 480. The electrodes 480 may, in addition to or instead of, be positioned on the contact surface 432 of the lower band 420, as well as on the second band 408. The two electrodes 480 may be configured to measure the impedance of the limb tissue between them. Thus, when the bladder 416 is inflated, the measured impedance undergoes a sharp change (spike) in a state where the two electrodes 480 each substantially bond to the skin. This occurs when the two electrodes 480 each have at least nominal perpendicular force to the skin. This abrupt change in impedance measurements when the impedance through limb tissue is being measured, with air no longer being an impedance component, is used by the microcontroller 419 to signal pump 453 to stop the injection of air into bladder 416. Here, bladder 416 is adjusted for a suitable or desired "fit" to the first band 404. Alternatively, in band 404, the internal pressure of bladder 416 may be measured using an internal pressure transducer (not shown). The bladder pressure can be monitored, and the microcontroller 419 signals pump 453 to stop the injection of air into bladder 416 when a pressure spike is detected.

[0043]

[0072] Figure 21 shows the user interface 410 in more detail. Display 412 includes a first line 433 configured to display the current or most recent measurement of systolic blood pressure, e.g., systolic arterial blood pressure. Display 412 includes a second line 431 for the current or most recent measurement of diastolic blood pressure, e.g., diastolic arterial blood pressure. Alternatively, instead of these two lines 433, 431 of text, a graph of blood pressure with time on the x-axis and pressure on the y-axis may be displayed. In other embodiments, the two lines 433, 431 of text may be replaced (or augmented by an additional line) with a single line showing the current or most recent measurement of mean pressure, e.g., mean arterial pressure (MAP). Blood pressure may be displayed in units of mmHg or other units, whether as a value or a graph. Display 412 includes a third line 429 for the current or most recent measurement of pulse or heart rate, e.g., heart rate per minute. Secondary or alternative display positions on Display 412 may be heart Rhythm change It may also show movement.

[0044]

[0073] The controller 414 in Figure 21 is assigned an on / off button 465 for the user to turn the user interface 410 on or off, a start / stop button 467 for the user to stop or start the therapeutic application program with or without automatic intermittent blood pressure measurement (depending on the programmed state), and a blood pressure measurement button 469 for the user to start a blood pressure measurement cycle. Alternatively, button 469 may be configured to start a pulse (heart rate) measurement cycle. Additional buttons, not shown, may be configured to notify emergency medical personnel. Alternatively, this task may be accomplished by pressing down one or more of the buttons on the controller 414. The wearable blood pressure control system 400 may be configured to communicate with a mobile phone or other mobile device to call an emergency system or a pre-programmed medical professional. Indicator lights 427, which may have LEDs, include an on / off status indicator 425, an indicator 423 for the active state of applied electrical stimulation, an indicator 421 for the active state of applied vibration / ultrasound, and an ECG indicator 413 that shows when an ECG is being measured. In other embodiments, the ECG indicator 413 may instead be configured to indicate when the electrode is not sufficiently bonded to the skin, or further, to indicate when the measured ECG is critical or to indicate the subject's arrhythmia. Any additional indicator lights 427 may be added to achieve these or other functions.

[0045]

[0074] Figure 22 shows a wearable blood pressure control system 500 having multimode energy delivery therapy including both vibration and electrical stimulation. The wearable blood pressure control system 500 is configured to wrap around the limb of a subject, as shown in Figures 25 and 27. A band 502 having a first end 504 and a second end 506 includes an inward-facing side 510 and an outward-facing side 512. The band 502 further includes an elastic fastener 508 having a first hook / loop region 514 configured to be secured to a second hook / loop region 516. The elastic fastener 508 comprises an elastic sheet configured to stretch longitudinally so that the band 502 can fit various limb diameters. When the band 502 is secured to the limb, an additional band 518 may be secured around the band 502 for additional fastening, but in some embodiments, only the band 502 is utilized. Further bands 518 may be similar to the second band 408 in Figure 19, but without any active components (piezoelectric discs 478, electrodes 480). In some embodiments, further bands 518 may constitute a band 404 having a bladder 416. The wearable blood pressure control system 500 includes eight conductive hydrogel electrodes 520 supported on the inner-facing side 510 of the band 502, and eight piezoelectric discs 522 (Figure 28) embedded beneath the electrodes 520. Each of the eight piezoelectric discs 522 is acoustically coupled by hydrogel so that they can be activated when the electrodes 520 are in contact with the user's skin. An adjustable inner surface 406, such as the inner surface of the wearable blood pressure control system 400 in Figure 15, may be incorporated instead, and two or more of the electrodes 520 may be used to measure the impedance of limb tissue, for automatic inflation of the bladder 416, and for automatic fit optimization. The multi-terminal connector 524 includes magnetic fasteners 526, 528 configured to magnetically position mating multi-terminal (e.g., multi-pin) connectors that may be attached to smartwatches, health trackers, fitness trackers, or smartphones, or other mobile control systems such as systems supported by a person or clothing or as part of clothing. Multiple contacts 530 enable various electrical connections in a small area.Sixteen contacts are shown, but any number is possible, for example, 2-32, 4-16, or 6-12. The pins of the multi-pin terminal may include spring-loaded electrical contact pins.

[0046]

[0075] The receptable 560 is configured to house an electronic identification device such as an RFID chip, EPROM, EEPROM, or a resistor for a Wheatstone bridge.

[0047]

[0076] Referring to Figure 28, a disk-shaped conductive hydrogel electrode 520 extends from the side 510 facing the inside of the band 502. The hydrogel electrode 520 can be flexible and stretchable, but these properties are not so necessary when the electrode 520 is small. Therefore, the size (e.g., diameter) of the electrode 520 can be varied depending on the specific geometric form of the array. The electrode 520 is bonded to a first surface 534 of a flexible substrate 531 (e.g., polyimide flex circuit material) via a conductive paint 532. The conductive paint 532 is electrically connected to a trace 552 on the first surface 534 of the flexible substrate 531. In some embodiments, the conductive paint 532 comprises silver-silver chloride (Ag-AgCl). In other embodiments, the conductive paint (ink) may comprise copper, gold, or other silver-based materials. A first portion 542 of the piezoelectric disk 536 is bonded to a first trace 546 on a second surface 538 of the flexible substrate 531 using conductive epoxy 540. The piezoelectric disk 536 may comprise a PZT material (lead zirconate titanate (Pb[Zr(x)Ti(1-x)]O3)) or another suitable ceramic material configured to vibrate in response to an applied voltage. A second portion 544 of the piezoelectric disk 536 is electrically coupled to a conductive tab 548, which in turn is electrically coupled to a second trace 550 on the second surface 538 of the flexible substrate 531. Thus, the electrode 520 is electrically coupled to the circuit on the first surface 534 of the flexible substrate, and the piezoelectric disk 536 is electrically coupled to the circuit on the second surface 538 of the flexible substrate 531. The flexible substrate 531 may comprise one or more thin strips within the band 502 (for example, between the upper sheet 554 and the lower sheet 556 of the band 502 which are coupled to each other). Each element (electrode or piezoelectric) of the eight electrode 520 / piezoelectric disk 536 layered pairs 558 may operate independently, or in some cases, both elements of the layered pairs 558 may operate simultaneously.

[0048]

[0077] The electrodes 520 may be electrically connected and arranged on the band 502 in various combinations to achieve a specific effect. In the wearable blood pressure control system 500' of Figures 24-25, the band 502 includes a first row 562 of four anode electrodes 520a and a second row 564 of four cathode electrodes 520c. When the band 502 is attached to the user 42's wrist 38, as in Figure 25, each anode-cathode pair 566a-566d is substantially aligned along the substantially longitudinal axis 568 of the median nerve 43, thereby setting the application of negative charge from cathode 520c and positive charge from anode 520a to the skin 570 at substantially longitudinally aligned positions 572, 574 to affect the conduction properties of the median nerve 43. In some cases, conduction of the median nerve 43 is increased by the action of the anode-cathode pairs 566a-566d, and in other cases, conduction of the median nerve 43 is decreased or impaired by the action of the anode-cathode pairs 566a-566d. During use, the user may achieve acceptable results with the band 502 in an orientation such as that shown in Figure 25, where the first lateral edge 576 of the band 502 is positioned proximal and the second lateral edge 578 of the band 502 is positioned distally. In other cases, the results may be undesirable, and therefore the user may remove and reattach the band 502 so that the first lateral edge 576 of the band 502 is positioned distal and the second lateral edge 578 of the band 502 is positioned proximal, in which case the results are improved. The traces 552, 546, 550 for each electrode 520 and piezoelectric disk 536 of the flexible circuit 580 (Figure 28) of the flexible substrate 531 can be manufactured in various patterns to achieve different electrical connections. The contacts 530 of the multi-terminal connector 524 may also be independently assigned to allow different electrical connection configurations. The median nerve 43 is often the target, but in other cases the effect may be concentrated on or shared with the radial or ulnar nerve. Alternatively, the band 502 may be placed in other locations (around the upper arm, around the forearm) or even around a part of the leg to obtain the desired effect.

[0049]

[0078] In the wearable blood pressure control system 500'' shown in Figures 26-27, the band 502 includes a first row 582 of four common ground electrodes 520m and a second row 584 of four electrodes 520w, 520x, 520y, and 520z configured to be excited independently of each other. When the band 502 is attached to the user's wrist 38, as in Figure 27, the common ground electrode 520m is positioned proximal and each of the independent electrodes 520w-520z is positioned distally. Since these electrodes are connected independently of each other, the independent electrodes 520w-520z can operate in a wide range of different patterns.

[0050]

[0079] In another embodiment, the electrodes 520 and piezoelectric discs 536 may each have an unequal number (e.g., six electrodes 520 and four piezoelectric discs 536) or an equal number. Several pairs 566 may be present in several parts of the band 502, while a single electrode 520 or a single piezoelectric disc 536 may be present in other parts of the band 502. The bands 502 of the wearable blood pressure control systems 500, 500', 500'' are shown without a bladder 416, but in other embodiments, each of the wearable blood pressure control systems 500, 500', 500'' may incorporate a bladder 416 to fit all sizes in one size, or for blood pressure measurement or therapeutic compression. The arrangement of electrodes 520 and piezoelectric discs 536 given herein allows for multiple contact points around the skin or limb, thereby potentially resulting in a faster drop in blood pressure.

[0051]

[0080] Another wearable blood pressure control system 600, shown in Figure 29, includes a housing 602 (similar to housing 402) and a band 604. The band 604 has a bracelet-like structure comprising five individual flex circuit portions 606a to 606e. Each of the flex circuit portions 606a to 606e has a conductive tracing 608 coupled to a component (e.g., electrodes, piezoelectric elements - not shown). In some embodiments, the components may be arranged as in the layered pairs 558 of Figure 28. A hinge joint 610 between each adjacent flex circuit portion 606a to 606e includes one or more conductors 612 that electrically connect them to each other. In some embodiments, the hinge joint 610 may include an elastic matrix to allow some elastic separation and recoil (stretching) between adjacent flex circuit portions 606a to 606e. Five flexible circuit sections 606a to 606e are shown in Figure 29, but any number, for example, 3 to 16 or 4 to 10, may be used. The thin and lightweight structure of the flexible circuit sections 606a to 606e, as well as the modular architecture and ease of manufacture, contribute to affordability and facilitate system installation.

[0052]

[0081] The above describes embodiments of the present invention, but other and further embodiments of the present invention may be conceived without departing from its basic scope. Although not described in detail above, the wearable blood pressure control system 400 of Figure 15, the wearable blood pressure control system 500 of Figures 22-23, and the wearable blood pressure control system 600 of Figure 29 may also be used in accordance with the methods described with respect to Figure 14.

[0053]

[0082] A method for controlling a subject's blood pressure includes the steps of: preparing a system for controlling blood pressure, comprising: a wearable interface having an internal contact surface, configured such that the wearable interface at least partially surrounds a first portion of the subject's first limb; a sensing module supported by the wearable interface and configured to determine changes in blood pressure in at least the subject's first limb; and an energy application module supported by the wearable interface and configured to apply two or more types of energy to the subject's first limb; placing the system on the patient's arm; measuring blood pressure using the system; and applying energy to the subject's radial nerve using the system. In some embodiments, the measurement step is performed two or more times a day. In some embodiments, the measurement step is performed three or more times a day. In some embodiments, the application step is performed two or more times a day. In some embodiments, the application step is performed three or more times a day. In some embodiments, the method includes applying energy to one or more nerves other than the subject's median nerve using the system. In some embodiments, the method includes applying energy to the subject's right median nerve using the system. In some embodiments, the method includes the step of applying energy to the left median nerve of the subject using the system, and in some embodiments, the method includes the step of positioning the system at or near the subject's wrist.

[0054]

[0083] A method for controlling a subject's blood pressure includes the steps of: preparing a system for controlling blood pressure, which includes a wearable interface having an internal contact surface and configured to at least partially surround a first portion of a subject's first limb; a sensing module supported by the wearable interface and configured to determine changes in blood pressure in at least the subject's first limb; and an energy application module supported by the wearable interface and configured to apply two or more types of energy to the subject's first limb; placing the system on the patient's arm; measuring blood pressure using the system; and applying energy to the subject's radial nerve using the system.

[0055]

[0084] A method for controlling a subject's blood pressure includes the steps of: providing a system for controlling blood pressure, comprising: a wearable interface having an internal contact surface, configured such that the wearable interface at least partially surrounds a first portion of a subject's first limb; a sensing module supported by the wearable interface and configured to determine changes in blood pressure in at least the subject's first limb; and an energy application module supported by the wearable interface and configured to apply two or more types of energy to the subject's first limb; placing the system on the patient's arm; measuring blood pressure using the system; and applying energy to the subject's ulnar nerve using the system.

[0056]

[0085] In some embodiments, one of the methods may include the step of stopping the application of energy when the patient's blood pressure drops.

[0057]

[0086] The scope disclosed herein includes any and all overlaps, partial scopes, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” and “between” includes the numbers listed. Numbers preceding terms such as “approximately,” “about,” and “substantially” as used herein include the numbers listed (e.g., approximately 10% = 10%), and represent amounts close to the stated amount that still perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to amounts within 10%, 5%, 1%, 0.1%, and 0.01% of the stated amount.

Claims

1. It is a system for controlling blood pressure. A wearable interface having an inner contact surface and configured to at least partially surround a first portion of a subject's first limb, A sensing module supported by the aforementioned wearable interface and having at least one modality selected from a list consisting of photoplethysmography and ultrasound, comprising a blood pressure sensor configured to output a signal relating to the blood pressure of the subject's first limb, An energy application module supported by the aforementioned wearable interface and configured to apply two or more types of therapeutic energy to the subject's first limb, A controller configured to receive data from the sensing module and to apply the two or more types of therapeutic energy to the subject's first limb in a first predetermined pattern, A system equipped with these features.

2. The system according to claim 1, wherein the sensing module is further configured to measure electrocardiogram data from the first limb of the subject.

3. The system according to claim 2, wherein the sensing module further comprises electrodes configured to measure the electrocardiogram data.

4. The system according to claim 1, wherein the two or more types of therapeutic energy include vibrational energy and electrical stimulation energy.

5. The system according to claim 4, wherein the energy application module comprises one or more piezoelectric elements configured to supply the vibrational energy.

6. The system according to claim 4, wherein the energy application module comprises one or more electrodes configured to supply the electrical stimulation energy.

7. The system according to claim 6, wherein each of the one or more electrodes is configured to contact the skin of the first portion of the first limb of the subject.

8. The system according to claim 1, wherein the energy application module comprises a hydrogel.

9. The system according to claim 1, wherein the energy application module can be detachably attached to the mountable interface and is configured to provide at least a portion of the inner contact surface of the mountable interface.

10. The system according to claim 1, further comprising a first electrode coupled to the inner contact surface at a first position and a second electrode coupled to the inner contact surface at a second position, wherein the first and second electrodes are configured to measure the impedance of the first portion of the first limb.

11. The system according to claim 1, wherein the first predetermined pattern is at least partially determined by the data received from the sensing module.

12. The system according to claim 11, wherein the sensing module is configured to measure one or more cardiovascular parameters, and the controller is configured to change the operation of the energy application module over time based on a change in at least one of the one or more cardiovascular parameters of the subject measured by the sensing module.

13. The system according to claim 1, wherein the sensing module is configured to measure one or more cardiovascular parameters.

14. The system according to claim 13, wherein one or more cardiovascular parameters include the heart rate of the subject.

15. The system according to claim 14, wherein the heart rate is calculated based on consecutive R points of the QRS complex in an electrocardiogram.

16. The system according to claim 13, wherein one or more cardiovascular parameters include the heart rate variability of the subject.

17. The system according to claim 16, wherein the heart rate variability of the subject is measured via a parameter in the time domain.

18. The system according to claim 16, wherein the heart rate variability of the subject is measured via a parameter in the frequency domain.

19. The system according to claim 1, wherein the first limb includes an arm, and the energy application module is configured to apply at least a portion of the therapeutic energy to the median nerve of the arm.

20. The system according to claim 1, wherein the energy application module comprises one or more piezoelectric elements and one or more electrodes, and at least one of the one or more piezoelectric elements and at least one of the one or more electrodes are supported by each other in a layered manner.

21. The system according to any one of claims 6, 7, or 20, wherein one or more electrodes are supported on a flexible circuit.

22. The system according to any one of claims 1 to 21, wherein the two or more types of therapeutic energy include vibrational energy in the range of 20 kHz to 1 MHz.

23. The system according to any one of claims 1 to 21, wherein the two or more types of therapeutic energy include vibrational energy in the range of 20 kHz to 700 kHz.

24. The system according to any one of claims 1 to 23, wherein the wearable interface is configured to at least partially surround a portion of the leg of the subject.

25. The system according to claim 1, wherein the controller is configured to analyze the data received from the sensing module and determine the presence of one or more medical conditions selected from a list consisting of bradycardia, ventricular tachycardia, other tachycardia, other ventricular arrhythmias, atrial fibrillation, atrial flutter, and other atrial arrhythmias.

Images