System for controlling blood pressure

Abstract

A system for controlling blood pressure includes a wearable interface having an inner contact surface, the wearable interface configured to at least partially surround a first portion of a first limb of a subject; and an energy application module carried by the wearable interface and configured to apply two or more types of energy to a first limb of the subject, where the energy application module includes a plurality of flexible electrodes configured to be operated such that the plurality of flexible electrodes apply a concentration effect to nerves of the first limb of the subject.

Description

[0001] This application is a divisional application of the Chinese national phase application with an international application date of March 1, 2019, an international application number of PCT / US2019 / 020240, and an invention name of “System and method for controlling blood pressure”. The national phase entry date of the Chinese national phase application is October 16, 2020, the application number is 201980026494.1, and the invention name is “System and method for controlling blood pressure”. Technical Field

[0002] Embodiments of the present invention relate to systems and methods for controlling blood pressure in a living being. Summary of the invention

[0003] In a first embodiment of the present invention, 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, the sensing module being carried by the wearable interface and being configured to at least determine blood pressure changes in the first limb of the subject; and an energy application module, the energy application module being carried by the wearable interface and being configured to apply two or more types of energy to the first limb of the subject.

[0004] In another 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 subject's limb; a sensing module, the sensing module being carried by the wearable interface and being configured to at least determine blood pressure changes in the subject's limb, wherein the sensing module includes at least one sensor for determining flow characteristics; and an energy application module, the energy application module being carried by the wearable interface and being configured to apply energy to the subject's limb.

[0005] In another embodiment of the present disclosure, a system 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; an energy application module, carried by the wearable interface and configured to apply two or more types of energy to the first limb of the subject, wherein the energy application module includes a plurality of flexible electrodes, the flexible electrodes being configured to be operated so that the plurality of flexible electrodes exert a concentrated effect on the nerves of the first limb of the subject.

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

[0007] In another embodiment of the present disclosure, a method for controlling the blood pressure of a subject includes providing a system for controlling blood pressure, the system comprising: a wearable interface having an inner contact surface, the wearable interface configured to at least partially surround a first portion of a first limb of the subject; a sensing module, the sensing module carried by the wearable interface and configured to at least determine blood pressure changes in the first limb of the subject; and an energy application module, the energy application module carried by the wearable interface and configured to apply two or more types of energy to the first limb of the subject, placing the system on the patient's arm, measuring blood pressure with the system, and applying energy to the radial nerve of the subject with the system.

[0008] In another embodiment of the present disclosure, a method for controlling the blood pressure of a subject includes providing a system for controlling blood pressure, the system comprising: a wearable interface having an inner contact surface, the wearable interface configured to at least partially surround a first portion of a first limb of the subject; a sensing module, the sensing module carried by the wearable interface and configured to at least determine blood pressure changes in the first limb of the subject; and an energy application module, the energy application module carried by the wearable interface and configured to apply two or more types of energy to the first limb of the subject, placing the system on the patient's arm, measuring blood pressure with the system, and applying energy to the ulnar nerve of the subject with the system. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a perspective view of a wearable blood pressure control system according to an embodiment of the present disclosure.

[0010] Figure 2 It is in a tight, unexpanded state. Figure 1 A perspective view of a wearable blood pressure control system.

[0011] Figure 3 It is in a tightened and partially expanded state. Figure 1 A perspective view of a wearable blood pressure control system.

[0012] Figure 4 is in a tightened, essentially expanded state Figure 1 A perspective view of a wearable blood pressure control system.

[0013] Figure 5 It is used on the user's wrist Figure 1 A perspective view of a wearable blood pressure control system.

[0014] Figure 6 During blood pressure measurement Figure 1 A perspective view of a wearable blood pressure control system.

[0015] Figure 7 is during activation in response to detected changes in blood pressure Figure 1 A perspective view of a wearable blood pressure control system.

[0016] Figure 8 It is used on the user's wrist Figure 1 Cross-section of a wearable blood pressure control system.

[0017] Fig. 9 is a perspective view of a wearable blood pressure control system according to an embodiment of the present disclosure.

[0018] Fig.10 yes Fig. 9 A plan view of the user interface of a wearable blood pressure control system.

[0019] Fig.11 is a perspective view of a wearable blood pressure control system according to an embodiment of the present disclosure.

[0020] Fig.12 is a perspective view of a wearable blood pressure control system according to an embodiment of the present disclosure.

[0021] Fig.13 is in an uncoupled state Fig.12 A perspective view of a wearable blood pressure control system.

[0022] Fig.14 is a flow chart describing a method for controlling blood pressure in a subject.

[0023] Fig.15 is a perspective view of a wearable blood pressure control system for use on a user's wrist according to an embodiment of the present disclosure.

[0024] Fig.16 yes Fig.15 An exploded view of the wearable blood pressure control system.

[0025] Fig.17 yes Fig.15A further breakdown of the wearable blood pressure control system.

[0026] Fig.18 yes Fig.15 Bottom view of the wearable blood pressure control system.

[0027] Fig.19 yes Fig.15 A perspective cutaway view of a sensing module of a wearable blood pressure control system.

[0028] Fig. 20A yes Fig.15 A first exploded view of the pump and bladder assembly of a wearable blood pressure control system.

[0029] Fig. 20B yes Fig.15 A second exploded view of the pump and armband assembly of the wearable blood pressure control system.

[0030] Fig.21 yes Fig.15 A plan view of the user interface of a wearable blood pressure control system.

[0031] Fig. 22 is a perspective view of a wearable blood pressure control system according to an embodiment of the present disclosure.

[0032] Fig.23 yes Fig. 22 Bottom view of the wearable blood pressure control system.

[0033] Fig.24 According to the embodiments of the present disclosure Fig. 22 and Fig.23 Active element array for a wearable blood pressure control system.

[0034] Fig.25 It is used on the user's wrist Fig.24 A perspective view of the active element array.

[0035] Fig.26 According to the embodiments of the present disclosure Fig. 22 and Fig.23 Active element array for a wearable blood pressure control system.

[0036] Fig. 27 It is used on the user's wrist Fig.26 A perspective view of the active element array.

[0037] Fig.28 It is intercepted by line 28-28 Fig. 22 A cross-sectional view of a wearable blood pressure control system.

[0038] Fig.29is a perspective view of a wearable blood pressure control system according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0039] Hypertension (high blood pressure) affects a large part 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 usually an important factor in increasing morbidity and mortality, either by itself or in combination with other diseases. Hypertension is considered a factor in approximately 18% of deaths worldwide. In most population subgroups, hypertension is of concern in all regions of the world. A small amount (e.g., about 5 mm Hg or more) of mean blood pressure reduction can significantly reduce stroke or other cardiovascular events.

[0040] According to several embodiments, described herein is a simple wearable device that can sense an increase in blood pressure and, in response, deliver blood pressure-lowering therapy. Figure 1 A wearable blood pressure control system 10 is shown configured to be placed on a patient's wrist. The wearable blood pressure control system 10 includes a housing 12 and a strap 14 coupled to an underside 16 of the housing 12. Figure 1 1 shows the wearable blood pressure control system 10 in an unfastened state. The strap 14 is secured to the underside 16 of the housing 12 by epoxy or adhesive 18. In other embodiments, the strap 14 may be secured by fasteners, sewing, fusing, or may be slid through a slit or elongated space in the housing 12. The strap 14 is configured to wrap around the wrist of the user / patient and be secured by using a hook and loop ( The inflatable armband 22 extends around a circumferential path 24 that encircles an interior 26 of the band 14. In some embodiments, the band 14 can be configured to be worn like a watch or bracelet, and can be configured to partially or completely encircle a limb (e.g., an arm) at a portion (e.g., a wrist). In alternative embodiments, the hook and loop system 20 can be replaced by a button closure, a snap closure, an adhesive closure, or a magnetic closure.

[0041] Figure 2 The wearable blood pressure control system 10 is shown in a secured state, wherein the loop surface 20a is secured to the hook surface 20b. Figures 2 to 4The user's arm is not shown in order to better illustrate the activity of the inflatable armband 22. The sensor 28 is carried on the inner face 30 of the band 14 and is configured to sense one or more cardiovascular parameters, such as heart rate, heart rate variability, electrocardiogram (ECG) (including any measured arrhythmia), or blood pressure. In some embodiments, the sensor 28 may include a pulse wave sensor. The pulse wave sensor may include 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 an alternative embodiment, the sensor 28 may include one or more optical sensors for performing photoplethysmography (PPG). The 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, which is configured to wirelessly communicate to a cellular phone, a smart phone, or other personal communication device, including a chip implanted in the user's body or carried on a portion of the user's body or clothing. Therefore, data monitoring and data analysis can be performed remotely. The controller 32 can be configured to analyze the data from the sensor 28 to determine the presence of a condition including bradycardia, tachycardia, atrial arrhythmia (such as atrial fibrillation or atrial flutter), or ventricular arrhythmia (such as ventricular tachycardia). The identification of any of these phenomena can be based on real-time analysis of heart rate, heart rate variability, or ECG amplitude. The sensor 28 can be capable of sensing more than one cardiovascular parameter. For example, the sensor 28 can be configured to sense blood pressure and heart rate, or blood pressure and heart rate variability, or can be configured to obtain an electrocardiogram and measure blood pressure. In some embodiments, the sensor 28 may include two or more sensors. In some embodiments, the two or more sensors may include a first sensor for measuring a first cardiovascular and a second sensor for measuring a second cardiovascular parameter, and the second cardiovascular parameter is different from the first cardiovascular parameter.

[0042] Changes in heart rate variability, such as a decrease in heart rate variability, have been shown to have some predictive power for mortality after a myocardial infarction. Using sensors 28 for more continuous or even continuous measurement of blood pressure allows for understanding how the heart responds to changing circumstances during each day. Rather than focusing on simply lowering average (average, mean) blood pressure values, heart disease can be better prevented by achieving hour-to-hour, day-to-day controlled blood pressure values ​​over time. These data can be used to help physicians make more informed decisions about the treatment of hypertension and overall treatment of the heart. The wearable blood pressure control system 10 is configured to monitor blood pressure at different activities throughout the day (eating, drinking, dieting, fasting, exercising, sleeping, walking, standing). The data obtained by the sensors 28 can be used intelligently to apply treatment based on specific or customized patient needs, and can be guided by the stored information related to the best time to apply treatment.

[0043] The inflatable armband 22 can operate as a sphygmomanometer armband configured to determine the user's blood pressure. The transceiver 34 can include a wifi antenna. The actuator 36 coupled to the controller 32 is configured to receive a signal from the controller 32 to inflate the inflatable armband 22. The actuator 36 can include a pneumatic pump configured to increase the air pressure within the inflatable armband 22. Figure 2 The inflatable cuff 22 is shown in a substantially uninflated state. Figure 3 The inflatable armband 22 in FIG. 1 is shown in a partially inflated state. Figure 4 The inflatable armband 22 in is shown as being in a substantially expanded state. The inflatable armband 22 can also be inflated by the controller 32 via the actuator 36 to apply therapeutic compression on the patient's wrist. In a first embodiment, the sensor 28 is configured to sense blood pressure, and the inflatable armband 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 armband 22 is configured to sense at least one parameter related to blood pressure and also apply therapeutic compression. In a third embodiment, the inflatable armband 22 is configured to sense blood pressure and 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 armband 22 is configured to sense at least one parameter related to blood pressure, and some other elements (not shown) are configured to apply therapy for lowering blood pressure.

[0044] exist Figure 5, the wearable blood pressure control system 10 is in use, placed on the wrist 38 of the arm 40 of the user 42. The band 14 can be secured adjacent to the hand 44 of the user 42, or can be attached around the wrist 38 (or other portion of the arm 40) at a distance d from the hand 44, such as 0.5 cm, 1 cm, 2 cm, 5 cm, 10 cm, or 15 cm, or any distance between 0 cm and 15 cm.

[0045] Go to Figure 8 , the wearable blood pressure control system 10 is shown coupled to the arm 40 of the user 42. Anatomical elements such as the radius 49, the ulna 51, the radial artery 45, and the ulnar artery 47 are shown relative to the band 14 and the housing 12. Figure 8 The positioning of the arm 40 in the inflatable armband 22 is one of many possible options. If a different juxtaposition between the sensor 28 and one or more of the arteries 45, 47 or between the inflatable armband 22 and one or more of the arteries 45, 47 is desired, the wearable blood pressure control system 10 can be oriented differently (e.g., circumferentially / rotationally and / or longitudinally / axially). The interior 53 of the inflatable armband 22 is inflated by air pressurized by the actuator 36, which freely enters the housing 12 (or exits from the housing 12) via the vent 55. The air is forced by the actuator 36 to enter the inflatable armband 22 through the inlet conduit 57 having the valve 59. The valve 59 is configured to maintain the air pressure in the interior 53 of the inflatable armband 22. 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 within the interior 53 of the inflatable armband 22.

[0046] exist Figure 6 In FIG. 4 , the sensor 28 in use senses the blood pressure 46 of the user 42. The blood pressure 46 may be measured continuously or in a series of samples. The blood pressure 46 may be considered as the systolic pressure over the diastolic pressure, or may be considered as the mean arterial pressure (MAP). The sensor 28 outputs a signal 48 proportional to the blood pressure 46 received by the controller 32. In FIG. Figure 7 In the embodiment, the controller 32 commands the actuator 36 to inflate the inflatable cuff 22. In the embodiment, wherein the inflatable cuff 22 is configured to be used as a blood pressure cuff, the controller 32 controls the inflation of the inflatable cuff 22 by the actuator 36 so that the inner 53 ( Figure 8 ) is pressurized to a starting pressure P above the expected maximum systolic arterial pressure s Controller 32 then commands actuator 36 and / or valve 59 to allow air to be released from interior 53 at a specific rate so that the pressure of interior 53 decreases to a pressure P below the expected minimum arterial diastolic pressure within time period T. fOscillometric sensing of occlusion and subsequent opening of one or more arteries (eg, by sensor 28) may also be used to determine actual systolic and diastolic pressures, and pressurization and depressurization of the inflatable cuff 22 may be controlled using this data (eg, by controller 32).

[0047] In an embodiment, in which the inflatable cuff 22 is configured to function as a therapeutic compression element, the controller 32 controls the inflation of the inflatable cuff 22 via the actuator 36 such that the interior 53 is pressurized to a desired therapeutic inflation pressure P t The therapeutic compression applied by the inflatable cuff 22 to the arm 40 can be directed to apply stress to the median nerve 43 ( Figure 8 ). Stimulating the median nerve by applying energy (such as compression) can help lower blood pressure via known neural pathways, which may include the central nervous system (CNS). In some cases, the reduction in blood pressure can be achieved by reducing sympathetic outflow. In some embodiments, the inflatable cuff 22 can be configured to function as both a sphygmomanometer cuff and a therapeutic compression element.

[0048] Fig. 9 A wearable blood pressure control system 100 is shown configured to be placed on a patient's wrist. The wearable blood pressure control system 100 includes a housing 102 and a strap 104 coupled to an underside 105 of the housing 102. Fig. 9 1 shows the wearable blood pressure control system 100 in a tightened state, but the arm 40 is not visible to better illustrate the features of the wearable blood pressure control system 100. A loop 106 is secured to a first portion 108 of the band 104, and a series of rubber wedges 110 are carried 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 someone 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 on the first end 114, pulls one or more wedges 110 through the opening 116 of the loop 106 until the band 104 is in a comfortably tight state around the user's wrist 38. A flat edge 118 of one of the wedges 110a abuts an edge 120 of the loop 106, locking it in place. To remove the strap 104, the strap 104 is forced in the opposite direction, temporarily (elastically) deforming the wedge 110 (or deforming the loop 106) and / or temporarily (elastically) deforming the loop 106 as the wedge 110 is pulled through the opening 116 in the loop 106. Alternatively, a hook and loop system 20 may be used, similar to Figure 1 The wearable blood pressure control system 100 further includes a user interface 101 on a visible surface 103 of a housing 102 .

[0049] The wearable blood pressure control system 100 includes an armband 122 extending circumferentially within the band 104 between the second end 124 and the first portion 108 of the band 104. The armband 122 is secured to the band 104 along a first edge 126 and a second edge 128, each of which runs circumferentially around the inner periphery of the band 104. The armband 122 may be secured to the band 104 at the first edge 126 and the second edge 128 by adhesive, epoxy, or heat-melt, or may be sewn, stapled, or secured by other fastening means. As named, the armband 122 represents the outer layer, although it is the inner portion of the circle when attached. As Fig. 9 As shown, the armband 122 is configured to have an inflatable interior space 130 .

[0050] The armband 122 carries a pair of sensing elements 132, 134 and a pair of vibrating elements 136, 138. The vibrating elements 136, 138 may include piezoelectric crystals, and may include quartz, artificial quartz, or PZT (lead zirconate titanate) ceramics. The vibrating elements 136, 138 may be configured to vibrate at ultrasonic frequencies between about 20kHz and about 1MHz, or between about 20kHz and about 700kHz, or between about 20kHz and about 500kHz, or between about 25kHz and about 500kHz, or between about 30kHz and about 200kHz, or between about 100kHz and about 300kHz. The frequencies between about 20kHz and about 700kHz can be very effective in stimulating nerves (such as the median nerve 43 in the arm 40, or the radial nerve or ulnar nerve). Ultrasound can be used to stimulate several physiological processes that can help lower blood pressure. Ultrasonic energy application can dilate blood vessels (such as arteries) and thus improve blood perfusion. Via sensory feedback, the brain receives a signal that modifies other physiological functions to further lower blood pressure. Therefore, the vibration elements 136, 138 can be configured to stimulate the median nerve 43 via vibration when they are made of appropriate materials and have an appropriate thickness to vibrate at one or more frequencies in the range of 20-700kHz. The vibration applied to the median nerve 43 will be sensed in the brain of the user 42, which correspondingly reduces blood pressure as part of a physiological feedback loop. Therefore, the brain is "tricked" into a more involved interventional role. In some embodiments, one vibration element 136 can be configured to vibrate in a lower frequency range (e.g., 20kHz to 100kHz), while another vibration element 138 can be configured to vibrate in a higher (ultrasonic) frequency range (e.g., 100kHz to 700kHz) to induce multiple types of effects. In other embodiments, two or more vibration elements 136, 138 can be configured to vibrate in a lower frequency range, while two or more additional vibration elements 136, 138 can be configured to vibrate in a higher frequency range. In some embodiments, one or more vibration elements 136, 138 can be configured to vibrate at multiple frequencies, such as a fundamental frequency (or first harmonic) and a second harmonic. For example, in a particular embodiment, the first harmonic can be 150kHz and the second harmonic can be 300kHz. In other embodiments, as described by the harmonic series, the third harmonic can be used, or even the fourth, fifth, or higher harmonics. A particular treatment regimen may include a first activation period of the vibration elements 136, 138 that is initiated immediately after the sensing elements 132, 134 detect a change (e.g., an increase) in blood pressure. This first activation period may be followed by pressurization of the armband 122. About Figures 1 to 8A further embodiment of the wearable blood pressure control system 10 may add a vibrating element 136, 138. A particular treatment regimen associated with this alternative embodiment may include a first activation period of the vibrating element 136, 138 that is initiated immediately after the sensor 28 detects a change (e.g., an increase) in blood pressure. This first activation period may be followed by an increase in the pressurization of the inflatable cuff 22. Although the median nerve 43 is typically the target, in other cases the effect may be focused or shared on the radial nerve or the ulnar nerve.

[0051] Return to Fig. 9 In some embodiments, the sensing elements 132 , 134 and the vibration elements 136 , 138 may be replaced by a multi-purpose element that is configured to perform both the sensing function of the sensing elements 132 , 134 and the energy applying function of the vibration elements 136 , 138 .

[0052] One or more of the sensing elements 132, 134 or the vibrating elements 136, 138, or a combination thereof, may be carried on an outer surface 140 of the armband 122, or may be carried on an inner surface 142 of the armband 122. The armband 122 is configured to maintain the sensing elements 132, 134 and the vibrating elements 136, 138 near the wrist 38 of the user 42 (or any other part of the limb to which the band 104 has been attached). For optimal acoustic coupling between the skin of the user 42 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 secured to the outer surface 140 and / or the inner surface 142 of the band 122 by an epoxy or adhesive 144 having appropriate transition acoustic impedance properties. 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.

[0053] Fig.10A user interface 101 is shown, which includes a power switch 109 configured to turn the wearable blood pressure control system 100 on or off. The user interface 101 may include a touch screen and may utilize capacitive or resistive touch sensitivity. Alternatively, a mechanical or membrane button / switch may be utilized. 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) vibration, medium vibration, 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 reduce the intensity of the vibration. Optionally, an application (App) 153 on 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 automatically adjust the vibration mode, turn the vibration mode on or off, or adjust the vibration mode between low, medium, and high vibrations. In some embodiments, the vibration pattern can be automatically adjusted via servo control or other methods so that the vibration elements 136, 138 are activated in a manner that is proportional to or in some way matches the decrease or increase in the amplitude, intensity, and / or prevalence of blood pressure changes. For example, the vibration elements 136, 138 can be configured to operate under a derived function of the blood pressure increase measured or calculated by the sensing elements 132, 134 (or by the armband 122 if used as a sphygmomanometer armband).

[0054] The 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 interior space 130 of the armband 122 can be manually set (e.g., set 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 can increase the pressure or injection volume of the inflation, while the other button 119, 121 can reduce the pressure or injection volume of the inflation. Optionally, the controller 151 and / or the App 153 within the housing 102 can be configured (via software or firmware) to receive one or more signals from the sensing elements 132, 134 and automatically adjust the compression mode, turn the compression mode on or off, or adjust the compression mode between low compression, medium compression, and high compression.

[0055] Fig.11 A wearable blood pressure control system 250 is shown, which is similar to Fig. 9The wearable blood pressure control system 100 of the embodiment of the present invention, but additionally includes stimulation electrodes 252, 254, 256 carried on the outer surface 140 of the armband 122. The user interface 101 and / or App 153 can be configured to adjust or program the controller 251 so that the signal received from one or more signals from the sensing elements 132, 134 causes current to flow through the wires or traces 258, 260, 262 electrically coupled to the electrodes 252, 254, 256, thereby applying one or more potentials (voltages) across two or more of the electrodes. The current can be applied using voltage control. The current can also be applied using current control. For example, the applied current can activate a nerve (such as the median nerve 43) to provide additional input to the patient's brain. The user interface 101 ( Fig.10 ) may include a third mode, which is an electrical stimulation mode, which can also be adjusted manually or by feedback from sensing elements 132, 134. Any combination of two or three (or more) modes may be possible, or in some embodiments, only a single mode. Electrodes 252, 254, 256 may be configured so that one or more applied potentials are directed to the median nerve 43 to thereby stimulate the median nerve 43 in order to change or induce the brain's control or modification of blood pressure. In alternative embodiments, electrodes 252, 254, 256 may be configured to sense physiological signals associated with changes in blood pressure or other cardiovascular parameters.

[0056] The controller 251 can be configured or programmable to be configured via hardware, firmware or software so that any one or more of the inflation of the armband 122, the activation of the electrodes 252, 254, 256 or the activation of the vibrating elements 136, 138 is applied to a specific range of set parameters or a set range of parameters, thereby acting as a programmable pulse generator. For example, in some embodiments, the voltage, current, frequency or pulse width of the activation of the electrodes 252, 254, 256 can be controlled within the following ranges. Current: 0.1 mA to 200 mA, or 0.1 mA to 50 mA; Application 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 μs to 1000 μs, or 1 μs to 1000 μs, or 0.01 μs to 5 μs. The controller 251 can discharge the electrodes in a continuous mode or in a random mode including one or more bursts. The on time of a burst and the off time of a burst can each be independently controlled. A specific program or algorithm can be used to change the on time and the off time. In an alternative embodiment, the controller 251 may be configured or programmable to be configured via hardware, firmware, or software such that any one or more of the inflation of the armband 122, the activation of the electrodes 252, 254, 256, or the activation of the vibrating elements 136, 138 are applied in an at least partially random or pseudo-random manner. The human body is adaptable, and many physiological systems tend to adjust in response to therapeutic treatments, sometimes in such a way that, to the body, appears to be helpful, when in fact, it is antagonistic to the purpose or effect of the treatment. The nervous system is able to change continuously through processes such as synaptic adaptation. Randomly adding variations to the manner in which the therapeutic elements (armband 122; vibrating elements 136, 138; applied electrodes 252, 254, 256) are applied can be used as a way to get ahead of or "cheat" the body's adaptation mechanisms, which may otherwise actually prove to be antagonistic to efforts to control blood pressure. Parameters that can be randomly or non-randomly adjusted by the controller 251 include: the time of applying energy (mechanical, electrical, etc.), the length of the time interval between applying energy, the number of repetitions of applying energy, the specific operating frequency of the non-static mode of energy (e.g., applying ultrasound at a varying pulse rate), the amplitude of the energy applied, the timing of a specific combination of more than one element of a specific type of energy, or two or more different types of energy. Any of these parameters can be increased or decreased. The controller 251 can 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 App153.In addition, in some embodiments, there can be security levels that control how much control the user has: a first level for the user and a second level for the prescribing physician. In some embodiments, the presence of controls available to the physician but not to the user can ensure a certain amount of randomness in the treatment. This may even be necessary in some cases, for example, for a particular patient who does not want to be surprised by a compression, electrode discharge, or vibration event. The security levels may include encryption and / or password controls. The "smart" nature of the wearable blood pressure control system 250 or any of the other systems described in the embodiments herein allows management by the attending physician, and therefore no specialist is required. Moreover, because the device does not require surgery or invasive procedures, only a single medical staff / location is required to be involved in the patient's care.

[0057] Fig.12 A wearable blood pressure control system 300 is shown with a multi-modal energy delivery therapy including both vibration and electrical stimulation. The wearable blood pressure control system 300 is similar to Fig. 9The wearable blood pressure control system 100 of FIG. 1 is a wearable blood pressure control system 100 of FIG. 1 , but does not include compression, and includes stimulation electrodes 302, 304, 306 carried on a limb-facing surface 308 of a band 310. The band 310 has a first end 330 and a second end 332 and is removably attached to a removable / replaceable housing 336. A loop 334 is secured to the band 310 and has an opening width W1. An insertion section 340 of the band 310 has a thickness W2 that is less than the opening width W1. A normal wall 338 of the band 310 has a thickness W3 that is slightly greater than the opening width W1, thereby creating a friction fit that makes the wedge 110 or hook / loop 20a / 20b unnecessary. In use, the user inserts the insertion section 340 into the loop 334 and pulls the band 310 from the first end 330 until it is adjusted to an acceptable amount on the wearer's limb. The friction between the normal wall 338 and the loop 334 maintains the band 310 secure. The user interface 312 and / or App 153 can be configured to adjust or program the controller 314 so that the signal sent by the controller in response to one or more signals from the sensing elements 316, 318 causes a current to flow through the wires or traces 320, 322, 324 electrically coupled to the electrodes 302, 304, 306, thereby applying one or more potentials (voltages) across two or more electrodes in the electrodes. The current can be applied using voltage control. The current can also be applied using current control. For example, the applied current can activate nerves (such as the median nerve 43) to provide additional input to the brain, which can 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 the sensing elements 316, 318. Any combination of these two modes is possible, so that a mixed signal can be generated. The mixed signal can include a cycle with a first cycle of only one of the vibration and stimulation and a second cycle of the other of the vibration and stimulation. The mixed signal may also include at least one cycle of simultaneous vibration and stimulation. Electrodes 302, 304, 306 may be configured such that one or more applied potentials are directed to the median nerve 43 to thereby stimulate the median nerve in order to alter or induce the brain's control or modification of blood pressure (e.g., lower blood pressure). In alternative embodiments, electrodes 302, 304, 306 may be configured to sense physiological signals associated with changes in blood pressure or other cardiovascular parameters. The combination of vibration and electrical stimulation working in sync can deliver customized optimal results and can be further informed by measuring cardiovascular parameters such as continuous blood pressure, heart rate, heart rate variability, or ECG (including detection of specific arrhythmias).

[0058] The controller 314 can be configured or programmable to be configured via hardware, firmware or software so that any one or more of the activation of the electrodes 302, 304, 306 or the activation of the vibrating elements 326, 328 is applied to a specific range of set parameters or a range of set parameters, thereby acting as a programmable pulse generator. For example, in some embodiments, the voltage, current, frequency or pulse width of the activation of the electrodes 302, 304, 306 can be controlled within the following ranges. Current: 0.1 mA to 200 mA, or 0.1 mA to 50 mA; Application frequency / rate: 0.01 Hz to 50 kHz, or 1 Hz to 5,000 Hz, or 1 Hz to 1,000 Hz, or 1 Hz to 200 Hz; Pulse width: 1 microsecond (μs) to 1000 milliseconds (ms), or 1 microsecond (μs) to 1000 microseconds (ms), or 0.01 milliseconds (ms) to 5 milliseconds (ms). The controller 314 can discharge the electrodes in a continuous mode or in a random mode including one or more bursts. The activation can include a specific initiation time (start time), a specific end time (stop time), and / or a specific duration. The activation period of the electrodes 302, 304, 306 can include one or more of the following patterns: a biphasic sine wave, a multiphasic wave, a monophasic sine wave, a biphasic pulsed sine wave, a biphasic rectangular wave, a monophasic square wave, a monophasic pulsating rectangular wave, a biphasic spike wave, a monophasic spike wave, and a monophasic pulsating spike wave. The on time of the burst and the off time of the burst can each be independently controlled. A specific program or algorithm can be used to change the on time and the off time. In an alternative embodiment, as described with respect to Fig.11 As described in the embodiments of the present invention, the controller 314 can be configured or programmable to be configured via hardware, firmware or software so that any one or more of the activation of the electrodes 302, 304, 306 or the activation of the vibrating elements 326, 328 are applied in an at least partially random or pseudo-random manner. Any of the electrodes 302, 304, 306 can be used as a patient return electrode, thus eliminating the need for an additional skin-placed return electrode patch. Therefore, a simple coupling of the band 310 on the limb of the wearer / user allows the wearer / user to immediately begin using the wearable blood pressure control system 300.

[0059] The electrodes 302, 304, 306 and the vibrating elements 326, 328 provide multiple touch points, which are located at different clock positions around the limb-facing surface 308 of the band 310, thereby allowing a high success rate because the best anatomical position for effective treatment is more likely to be identified and treated. The controller 314 can be configured to allow the user / patient to control some or all of these parameter adjustments, for example, via the user interface 312 and / or the App 153. In addition, in some embodiments, there may be a security level that controls how much the user can control: a first level for the user and a second level for the prescribing physician. In some embodiments, the presence of controls available to the physician but not available to the user can ensure a certain amount of randomness in the treatment. This may even be necessary in some cases, for example, for a particular patient who does not want to be surprised by an electrode discharge or vibration event. The security level may include encryption and / or password control. The connection port 191 can be used to temporarily or permanently attach a USB cable, a USB drive, or other cable or drive to transfer information, charge an internal battery, or supply power to any internal component. Many of the components described in the wearable blood pressure control system 300 have relatively low power requirements, which are suitable for a rechargeable battery system. If desired, the connection port 191 can also be used to attach a wireless antenna, regardless of whether there is internal wireless capability within the wearable blood pressure control system 300. This communication can 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 locations.

[0060] The wearable blood pressure control system 300 may include adaptive capabilities. For example, the controller 314 may be programmable or preprogrammed to provide a specific treatment plan, such as applying energy in the morning, applying energy at noon, and applying energy in the evening. However, by analyzing changes in one or more cardiovascular parameters measured by the sensing elements 316, 318, the controller 314 may be configured to change the treatment plan to optimize the patient response. For example, the change may include a larger amplitude and / or a longer duration of applying vibration energy and a smaller amplitude and / or a shorter duration of applying electrical stimulation energy. Or, in other cases, the change may include a larger amplitude and / or a longer duration of applying electrical stimulation energy and a smaller amplitude and / or a shorter duration of applying vibration energy. An energy modulation algorithm may be applied to allow the wearable blood pressure control system 300 to learn to better deliver customized neuromodulation management to each wearer, which may correspond to each patient's blood pressure or other cardiovascular parameters. The wearable blood pressure control system 300 is thereby able to learn from each patient's physiology and treatment effects for personalized and optimized treatment. Each individual energy modality (applying electrical stimulation or applying vibration) can be optimized, and a combination of more than one energy modality can also be optimized. The heartbeat intervals used in calculating heart rate or heart rate variability can be derived from ECG data or from blood pressure data. In some embodiments, the RR intervals (continuous R points in the QRS complex from the ECG) are used. When referring to the RR intervals in the normal heartbeats of the heart, or more specifically, when the heartbeats of the heart do not include heartbeats that do not originate in the sinoatrial node, the RR intervals are sometimes referred to as NN intervals. In some embodiments, time domain methods can be used for heartbeat-related calculations. In other embodiments, geometric methods can be used for heartbeat-related calculations. In other embodiments, frequency domain methods can be used for heartbeat-related calculations.

[0061] exist Fig.13 , the housing 336 has been removed from the band 310. The housing 336 is removable from the band 310 and reattachable to the band 310 for a variety of reasons. The housing 336 may include one or more rechargeable batteries that are capable of being recharged by attaching a power cable to the connection port 191 or to another port connected to the battery. The battery may be rechargeable by wire or by wireless methods, including inductive coupling charging. The wireless charging unit 345 may also be used to charge the battery. In alternative embodiments, one or more of these batteries may be primary batteries that are configured to be used and discarded (or recycled). The housing 336 is secured to the band 310 via two magnets 346, 348 that are configured to attract magnets 350, 352 carried on the surface 344 of the band 310. In Fig.13In an embodiment, magnet 348 has a positive pole facing outward, which is configured to magnetically engage with magnet 350 having a negative pole facing outward. Magnet 346 has a negative pole facing outward, which is configured to magnetically engage with magnet 352 having a positive pole facing outward. The magnet may include a rare earth magnet, such as neodymium iron boron or samarium cobalt. The neodymium iron boron magnet may be selected from a grade 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 a grade between N30 and N52, or between N33 and N50, or between N35 and N48. In some embodiments, one of the two magnets in each attracting pair may be replaced by a magnetic material (such as iron or 400 series stainless steel) that is attracted to the magnetic poles of the opposing magnets.

[0062] Electrical connections may be made by conductive protrusions 354 carried on the band 310 and configured to conductively engage conductive recesses 356 carried on the bottom surface 342 of the housing 336. These conductive recesses 356 are electrically connected to various electrical components of the housing 336, which may include the user interface 312, the controller 314, and the connection port 191. The conductive protrusions 354 are electrically connected to the traces 320, 322, 324 and the stimulation electrodes 302, 304, 306, the vibration elements 326, 328, and the sensing elements 316, 318 ( Fig.12 ). Thus, when the shell 336 is attached to the band 310 via the attraction of the magnets 346, 348, 350, 352, the conductive protrusion 354 is electrically coupled to the conductive recess 356. The user interface 312, controller 314 and connection port 191 are thereby electrically interconnected with the traces 320, 322, 324 and the stimulation electrodes 302, 304, 306, the vibration elements 326, 328 and the sensing elements 316, 318. The user may choose to remove the shell 336 from the band 310 for reasons other than recharging. For example, if the first shell 336 becomes damaged or stops functioning, the first shell 336 may be replaced by the second shell 336. The shell 336 may be removed to present to a medical facility that can upload or download information or software revisions, or for maintenance or repair. The conductive protrusion 354 and the conductive recess 356 are Fig.13354 and / or the conductive recesses 356 may be located laterally from the magnets 350, 352 and / or the magnets 346, 348, respectively, but in other embodiments, the conductive protrusions 354 and / or the conductive recesses 356 may be located laterally from the magnets 350, 352 and / or the magnets 346, 348. In some embodiments, the conductive protrusions 354 and the conductive recesses 356 may each be replaced by a series of conductive terminals each having both a protrusion and a recess, or by a series of terminals having a substantially planar array of conductive terminals (with neither protrusions nor recesses).

[0063] In alternative embodiments, the magnets 346, 348, 350, 352 may be replaced by other connections, such as snaps, hooks and loops. Slide joint or adhesive strip.

[0064] about Fig.14 A method for controlling blood pressure in a subject is described. In a first step 360, a wearable blood pressure control system 10, 100, 250, 300 is provided. In a second step 362, the wearable blood pressure control system 10, 100, 250, 300 is placed on an arm of the subject. The wearable blood pressure control system 10, 100, 250, 300 may be placed proximate to the median nerve 43. In some cases, the wearable blood pressure control system 10, 100, 250, 300 may be placed on the right arm proximate to the right median nerve. In some cases, the wearable blood pressure control system 10, 100, 250, 300 may be placed on the left arm proximate to the left median nerve. In some cases, a first wearable blood pressure control system 10, 100, 250, 300 may be placed on the right arm proximate to the right median nerve, and a second wearable blood pressure control system 10, 100, 250, 300 may be placed on the left arm proximate to the left median nerve.

[0065] In a third step 364, the wearable blood pressure control system 10, 100, 250, 300 measures the blood pressure of the subject. The blood pressure may be measured via a sphygmomanometer armband in some cases, and in other cases, the blood pressure may be measured by a blood pressure sensor. In some cases, the sensor and the sphygmomanometer armband may work in conjunction with each other to measure the blood pressure. The measured blood pressure may be presented or analyzed as systolic pressure relative to diastolic pressure, or may be presented or analyzed as mean arterial pressure (MAP) in other cases. In a fourth step 366, if the blood pressure is determined to be high, or high, or high blood pressure, or above a predetermined threshold, the wearable blood pressure control system 10, 100, 250, 300 applies energy to the median nerve of the arm on which the wearable blood pressure control system 10, 100, 250, 300 is worn. The energy applied may include compressive stress (pressure), or electrical stimulation, or vibration stimulation, ultrasonic stimulation, or heat application, or heat removal (cooling), or magnetic exposure, or electromagnetic exposure, or acoustic stimulation, or other mechanical energy application. In some cases, applying energy to the median nerve can have a duration of between about 5 minutes and about 1 hour, or between about 10 minutes and about 45 minutes, or between about 15 minutes and about 35 minutes, or between about 20 minutes and about 30 minutes, or between about 1 minute and about 10 minutes, or between about 5 minutes and about 10 minutes. The combination of energy application modalities (e.g., vibration and electrical stimulation) can be effective in significantly reducing the time required to lower a patient's blood pressure. Once elevated blood pressure is sensed, the combination of energy application modalities can lower blood pressure in less than about 15 minutes or less than about 10 minutes, which is significantly faster than conventional single energy modalities.

[0066] The wearable blood pressure control system 10, 100, 250, 300 may be configured or programmable so that step 364 (and if determined by the system to be appropriate, step 366) occurs at specific times of the day when the subject wears the wearable blood pressure control system 10, 100, 250, 300. For example, the steps may be for a) when the subject wakes up or gets out of bed, b) at a specific time in the morning (e.g., after eating), c) at a specific time in the middle of the day (e.g., just before, during, or just after lunch), before going to bed, or at some other time in the evening. The wearable blood pressure control system 10, 100, 250, 300 may be configured or programmable to perform step 364 once, twice, three times, or more times per day. The wearable blood pressure control system 10, 100, 250, 300 may be configured or programmable to perform step 366 once, twice, three times, or more times per day.

[0067] Fig.15 A wearable blood pressure control system 400 is shown with a multi-modal energy delivery therapy including both vibration and electrical stimulation. The wearable blood pressure control system 400 includes Fig.11Wearable blood pressure control system 250, Fig.12 Wearable blood pressure control system 300 and Fig. 9 The wearable blood pressure control system 100 of the present invention has the characteristics of the wearable blood pressure control system 100, and has other different features. The housing 402 is connected to the first belt 404 by any means described herein. The first belt 404 having a first end 401 and a second end 403 includes an adjustable inner surface 406, and the first belt 404 is configured to be inflated to allow the first belt 404 to fit a wide range of limb sizes (e.g., arm circumference, wrist circumference, etc.). The first belt 404 can be fixed to itself by a hook and loop system or any of the other modes described herein with respect to other embodiments. The second belt 408 is carried in parallel with the first belt 404 and is configured to place the sensing module and / or the energy application module close to the limb. The sensing module can be configured to measure one or more cardiovascular parameters, including blood pressure, electrocardiogram data, heart rate, or heart rate variability from the limb. The energy application module can be configured to deliver two or more types of energy to the limb, such as vibration energy or electrical stimulation energy. A user interface 410 with a display 412 and a control member 414 is carried on the top of the housing 402.

[0068] Fig.16 404 includes an inflatable armband 416 sealed within an upper band 418 and a lower band 420. The armband 416 may include a relatively high strength flexible material, such as polyurethane or polyethylene terephthalate (PET). The armband 416 may include an upper sheet 405 and a lower sheet 407 sealed around a perimeter seal 409. The upper band 418 and the lower band 420 may include a fabric, such as a woven polyamide (nylon). The perimeter 422 of the upper band 418 is sealed to the perimeter 424 of the lower band 420 so that when the internal cavity 426 of the armband 416 is inflated with air, the lower band 420 is forced away from the band 418 in a radial direction, except at the circumferential seams 428, 430 ( Fig.15 ). Thus, the contact surface 432 of the lower band 420 serves as an adjustable inner surface 406 configured to contact the skin of a user's limb. The perimeters 422, 424 may be sealed to one another with a hot melt adhesive, thermal bonding, or epoxy or adhesive. The armband 416 includes an inlet port 434 for an inflation fluid (e.g., air) to enter and an outlet port 436 for the inflation fluid to exit. Fig.17 As shown, each of the ports 434, 436 has an outer diameter 438, an inner diameter 440, and tapered snap-fit ​​wings 442, 444. Fig.16, ports 434, 436 extend through holes 446, 448, respectively, of upper band 418, making them accessible for attachment to main housing 450 of housing 402. Without bonding at bonding area 454, armband 416 is trapped (e.g., sandwiched) between upper band 418 and lower band 420. Thus, the armband is not overly constrained relative to upper band 418 or lower band 420, and the outer surface of armband 416 is able to slide along the inner surfaces of upper band 418 and lower band 420 when armband 416 is inflated. In an alternative embodiment, armband 416 includes an upper surface 452 having a bonding area 454 at least around its perimeter 458 or a portion of its perimeter 458, which is bonded to the underside 456 of upper band 418. Bonding area 454 can be sealed to the underside 456 of band 418 by hot melt adhesive, thermal bonding, or epoxy or adhesive.

[0069] The attachment pin 460 has a distal end 462 that is attached to a hole 466 in the first end 470 of the second strap 408 and a proximal end 464 of increased diameter that is configured to removably snap into one of a series of holes 468 in the second end 472 of the second strap 408. Fig.18 As shown, the second band 408 is secured to the first band 404 along a lateral edge 474 so that when the first band 404 and the second band 408 are secured around a limb, a series of active elements 476 are coupled to the skin proximate to the limb. The securing of the second band 408 to the first band 404 can be achieved by sewing, welding, overmolding, or heat bonding. Fig.16 , the active element 476 includes four ceramic piezoelectric disks 478 (478a-478d) and four electrodes 480 (480a-480d). The piezoelectric disks 478 can be completely molded within the second strip 408. The second strip 408 can include a material that acoustically couples to the piezoelectric crystals of the piezoelectric disks 478, such as a silicone elastomer. The electrodes 480 are exposed at a contact surface 482 of the second strip 408, such as Fig.18 As shown, when the second band 408 is secured to the user's limb, the electrode can directly contact the user's skin. An acoustic coupling gel can be used on the contact surface 482 and the electrode 480 to maximize coupling to the subject's skin. Fig.19, the second band 404 is shown transparently so that the active elements 476 are visible in their embedded array. Each piezoelectric disc 478a-478d has a conductive layer 484, which can be applied by sputtering or other forms of deposition. The first wire 486 and the second wire 488 are welded to the conductive layer 484 at the first exposed ends 490, 492. The wires 486, 488 may include an outer insulating sheath 494, 496 along most of their length. The second exposed ends 498, 499 of the wires 486, 488 are configured to be electrically coupled to electronic components within the housing 402. Each electrode 480a-480d is welded to the exposed end 497 of the wire 495 having the insulating sheath 493. The second exposed end 491 is configured to be electrically coupled to the electronic components within the housing 402. The lateral edge 474 of the second band 408 includes a plurality of snaps 489, which are configured to snap and secure the insulating jackets 493, 494, 496 of the wires 495, 486, 488 to hold the wires 495, 486, 488 in place relative to the second band 408 and the first band 404, thereby holding them in place and providing strain relief.

[0070] Return to Fig.16 , the main housing 450 includes a main circuit board 487 and a liquid crystal display (LCD) 485 covered by a glass cover 483. These components are enclosed within the main housing 450 by a cover 481, which is secured to the main housing by screws 479. The user interface 410 is adhered to the cover 481 by a formed adhesive layer 477. The actuatable buttons 475, 473, 471 coupled to the main circuit board 487 are accessible via touch buttons 469, 467, 465 of the user interface 410 and via cutouts 463, 461 in the cover 481 and the adhesive layer 477, respectively. Fig.17Tactile switches 459, 457, 455 are shown to be actuated by pressing the actuable buttons 475, 473, 471, respectively. In alternative embodiments, the user interface may include capacitive touch sensitivity or resistive touch sensitivity. The diaphragm pump 453 is carried on the auxiliary circuit board 451, which is configured to control blood pressure measurement. The pump 453 may include a piezoelectrically actuated micro pump. The spacer 449 is configured to separate the auxiliary circuit board 451 from the main circuit board 487 for space or cooling considerations, but the main circuit board 487 is electrically coupled to the auxiliary circuit board 451. Any of the circuit boards 451, 487 can be manufactured by printing or other large-scale manufacturing techniques. Power is provided to the electronic components by a battery 447 also contained in the housing 402. In some embodiments, the battery includes a rechargeable battery. In some embodiments, the battery includes 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 some of this power to drive the pump 453. The microcontroller 419 is carried on the main circuit board 487, but may alternatively be carried on the auxiliary circuit board 451. The microcontroller 419 may be programmed or programmable to control the operation of any function 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) latency, row address to column address delay, row precharge time, or row activation time.

[0071] Additional electrodes 445, 443 are carried in circular recesses 437, 435 in the sides 441, 439 of the main housing 450, respectively, and are 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, 451 can be configured to receive input from one or more of the electrodes 480a-480d and the electrodes 445, 443 to obtain electrocardiogram data (ECG). In use, the subject places the wearable blood pressure control system 400 on a first limb, for example, by wrapping the bands 404, 408 around the subject's left wrist and securing them. The subject then initiates an electrocardiogram measurement via the user interface 410, and then touches any one of the electrodes 445, 443 of the main housing 450 with a finger of the subject's right hand. The electrodes 480a-480d, 445 (or electrodes 480a-480d, 443 or other combinations) together create multiple ECG vectors to allow useful cardiovascular data. The combination of both the left wrist and the right hand (via at least one finger) provides important bilateral input for a reliable and physiologically indicative electrocardiogram (ECG). In some embodiments, the touch of a finger to the electrode 445 or the electrode 443 automatically initiates an ECG measurement without using the touch buttons 469, 467, 465 of the user interface 410. In some embodiments, the control circuit can be configured or programmed so that the touch of a finger to one of the electrodes 445, 443 initiates and maintains the ECG measurement, and the removal of the finger stops the ECG measurement.

[0072] Fig. 20A and Fig. 20B The connection between the armband 416 and the pump 453 is shown. The pump 453 includes an outlet port 371 fixed to the internal cylindrical cavity 375 in the main housing 450. An O-ring 369 carried around the outlet port 371 provides a seal between the pump 453 and the main housing 450 because the O-ring 369 seals the communication between the outlet port 371 and the cavity 375. The exhaust port 367 with the O-ring 365 around it is sealed to the internal cylindrical cavity 363 in the main housing 450. Thus, air evacuated from the armband 416 will exit through the auxiliary circuit 451 and enter the interior of the housing 402. The solenoid 361 ( Fig.17) can be controlled by the microcontroller 419 to close or open the solenoid 361, thereby keeping air in the armband 416 or allowing air to leave the armband 416. The snap bracket 399 is inserted by inserting the lugs 395, 393 of the snap bracket 399 into the slots 391, 389 of the main housing 450, respectively, and then tightening a screw (not shown) through the hole 387 in the snap bracket 399 and into the threaded hole 385 in the underside 397 of the main housing 450. The ports 434, 436 of the armband 416 snap into the holes 383, 381 of the snap bracket 399, respectively. The tapered snap wings 442, 444 allow the ports 434, 436 to be guided into the holes 383, 381 and securely attached to the snap bracket 399 and the main housing 450 (and thereby, the housing 402). In some embodiments, the tapered portion of the tapered buckle wings 442, 444 is only on the introduction side (as shown), and therefore the armband 416 can be attached to the housing 402, but not separated. In other embodiments, there can also be a tapered portion on the lower side of the tapered buckle wings 442, 444, and therefore the armband 416 can be attached to the housing 402 and separated from it. In some embodiments, the armband 416 and the first band 404 can be configured to be disposable and replaceable. In these embodiments, the first band 404 and the second band 408 can be removably connected to each other, for example, using buckles, hooks and loops, ribs and grooves, or adhesive attachments. When the ports 434, 436 are buckled by the holes 383, 381, the tapered hubs 379, 377 with the extensions of the internal cavities 375, 373 are sealedly engaged in the inner diameter 440 of the ports 434, 436. This completes the sealed communication between the pump 453 and the armband 416.

[0073] The adjustable inner surface 406 of the first band 404 is configured to automatically inflate to the appropriate size (e.g., by the armband 416 inflated with a specific volume of air by the pump 453) so that it applies an appropriate amount of compression (radially applied pressure) to the limb at the attachment site. The microcontroller 419 can be programmed or programmable to initiate an armband inflation cycle using feedback from any two electrodes in the electrodes 480. The electrodes 480 can be additionally or alternatively located on the contact surface 432 of the lower band 420, rather than only on the second band 408. The two electrodes 480 can be configured to measure the impedance of the limb tissue between them. Therefore, when the armband 416 is inflated, the measured impedance causes the two electrodes 480 to each become substantially coupled to the skin and produce a sudden change (spike). This occurs when the two electrodes 480 each have at least a nominal normal force on the skin. When measuring the impedance through the limb tissue (where air is no longer an impedance component), this sudden change in the impedance measurement can be used by the microcontroller 419 to send a signal to the pump 453 to stop injecting air into the armband 416. The armband 416 is now adjusted for the proper or desired "fit" of the first band 404. Alternatively, in the band 404, the internal pressure of the armband 416 can be measured with an internal pressure transducer (not shown). The armband pressure can be monitored, and when a spike in pressure is detected, the microcontroller 419 will send a signal to the pump 453 to stop injecting air into the armband 416.

[0074] Fig.21 4 shows the user interface 410 in more detail. The display 412 includes a first line 433 configured to display the current or latest measurement of systolic pressure (e.g., systolic arterial pressure). The display 412 includes a second line 431 of the current or latest measurement of diastolic pressure (e.g., diastolic arterial pressure). Alternatively, instead of the two lines of text 433, 431, a blood pressure graph can be displayed, where time is on the x-axis and pressure is on the y-axis. In other embodiments, the two lines of text 433, 431 can be replaced by a single line showing the current or latest measurement of mean pressure (e.g., mean arterial pressure (MAP)) (or can be enhanced by additional lines). Whether it is a value or a graph, blood pressure can be displayed by units of mm Hg or by other units. The display 412 includes a third line 429 for the current or latest measurement of pulse or heart rate (e.g., beats per minute). The second or alternative display position on the display 412 can indicate heart rate variability.

[0075] Fig.21The controls 414 in are assigned to: an on / off button 465, by which the user turns the user interface 410 on or off; a start / stop button 467, by which the user stops or starts the program of the therapeutic application with or without automatic intermittent blood pressure measurement (depending on the programming state); and a blood pressure measurement button 469, by which the user initiates a blood pressure measurement cycle. Optionally, button 469 can be configured to initiate a pulse (thermal rate) measurement cycle. Although not shown, an additional button can be configured to notify emergency medical personnel. Optionally, pressing and holding one or more of the controls in the controls 414 can achieve this task. The wearable blood pressure control system 400 can be configured to communicate with a mobile phone or other mobile device to call an emergency system or to a preprogrammed medical professional. The indicator lights 427, which may include LEDs, include: an on / off status indicator 425; an indicator 423 of the activation status of the applied electrical stimulation; an indicator 421 of the activation status of the applied vibration / ultrasound; and an ECG indicator 413, which indicates when the ECG is measured. In other embodiments, the ECG indicator 413 may alternatively be configured to indicate when the electrodes are not adequately coupled to the skin, or may even indicate when the measured ECG is critical or indicates a cardiac arrhythmia in the subject. Any additional indicator lights 427 may be added to achieve these or other functions.

[0076] Fig. 22 A wearable blood pressure control system 500 is shown with a multi-modal energy delivery therapy including both vibration and electrical stimulation. The wearable blood pressure control system 500 is configured to be wrapped around a subject's limb, such as Fig.25 and Fig. 27 502. The strap 502 having a first end 504 and a second end 506 includes an inwardly facing side 510 and an outwardly facing side 512. The strap 502 also includes an elastic clasp 508 having a first hook / loop area 514 that is configured to be secured to a second hook / loop area 516. The elastic clasp 508 includes an elastic sheet that is configured to stretch longitudinally so that the strap 502 will fit over limbs of various diameters. When the strap 502 is secured to the limb, an additional strap 518 can be secured around the strap 502 for additional securement, but in some embodiments, the strap 502 is used alone. The additional strap 518 can be similar to Fig.19 The wearable blood pressure control system 500 includes eight conductive hydrogel electrodes 520 carried on the inner-facing side 510 of the band 502 and eight piezoelectric discs 522 embedded below the electrodes 520 ( Fig.28). Each of the eight piezoelectric discs 522 is acoustically coupled via the hydrogel so that they can be operable when the electrodes 520 contact the user's skin. Fig.15 The adjustable inner surface 406 of the wearable blood pressure control system 400 can be alternatively incorporated, and two or more of the electrodes 520 can be used to measure the impedance of the limb tissue for automatic inflation and automatic fit optimization of the armband 416. The multi-terminal connector 524 includes magnetic fasteners 526, 528, which are configured to magnetically locate a matching multi-terminal (e.g., multi-pin) connector that can be attached to a smart watch, health tracker, fitness tracker or smart phone, or other mobile control system, such as a system carried on a person or clothing, or as part of clothing. Multiple contact points 530 allow different electrical connections in a small area. Sixteen contact points are shown, but any number is possible, for example, including two to 32, four to sixteen, or six to twelve. The pins of the multi-pin terminal may include spring-loaded electrical contact pins.

[0077] The socket 560 is configured to house an electronic identification device, such as an RFID chip, an EPROM, an EEPROM, or a resistor for a Wheatstone Bridge.

[0078] Go to Fig.28, a disc-shaped conductive hydrogel electrode 520 extends from the inner-facing side 510 of the strip 502. The hydrogel electrode 520 can be flexible and stretchable, but these properties are less desirable if the electrode 520 is small. Thus, the size (e.g., diameter) of the electrode 520 can vary depending on the specific geometry of the array. The electrode 520 is coupled to a first surface 534 of a flexible substrate 531 (e.g., a polyimide flexible circuit material) via a conductive coating 532. The conductive coating 532 is electrically connected to a trace 552 on the first surface 534 of the flexible substrate 531. In some embodiments, the conductive coating 532 includes silver-silver chloride (Ag-AgCl). In other embodiments, the conductive coating (ink) can include copper or gold, or other silver-based materials. The first portion 542 of the piezoelectric disc 536 is bonded to the first trace 546 on the second surface 538 of the flexible substrate 531 with a conductive epoxy 540. The piezoelectric disk 536 may include a PZT material (lead zirconate titanate (Pb[Zr(x)Ti(lx)]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 a 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 include one or more thin strips within the ribbon 502 (e.g., between an upper sheet 554 and a lower sheet 556 of the ribbon 502 that are bonded together). Each element (electrode or piezoelectric element) of each of the eight electrode 520 / piezoelectric disk 536 layered pairs 558 may operate independently, or in some cases, the two elements of the layered pairs 558 may operate in coordination.

[0079] The electrodes 520 may be electrically connected and arranged in various combinations on the strip 502 to achieve a particular effect. Figure 24 to Figure 25 In the wearable blood pressure control system 500', the band 502 includes a first row 562 of four anode electrodes 520a and a second row 564 of four cathode electrodes 520c. Fig.25As shown, when the band 502 is attached to the wrist 38 of the user 42, each anode-cathode pair 566a-566d is aligned substantially along the general longitudinal axis 568 of the median nerve 43, so that the negative charge from the cathode 520c and the positive charge from the anode 520a are applied to the skin 570 at substantially longitudinally aligned locations 572, 574 configured to affect the conduction characteristics of the median nerve 43. In some cases, the conduction of the median nerve 43 is increased by the operation of the anode-cathode pairs 566a-566d, and in other cases, the conduction of the median nerve 43 is reduced or interrupted by the operation of the anode-cathode pairs 566a-566d. In use, the user can Fig.25 The orientation of the strap 502 shown achieves acceptable results, wherein the first side edge 576 of the strap 502 is located proximally and the second side edge 578 of the strap 502 is located distally. In other cases, the results may be undesirable, and the user may remove and reattach the strap 502 so that the first side edge 576 of the strap 502 is located distally and the second side edge 578 of the strap 502 is located proximally, wherein the results are improved. Fig.28 ) can be manufactured in a variety of patterns to achieve different electrical connections. The contact points 530 of the multi-terminal connector 524 can be independently assigned to also allow different electrical connection configurations. Although the median nerve 43 is usually the target, in other cases, the effect can be concentrated or shared on the radial nerve or ulnar nerve. The band 502 can alternatively be located in other locations (around the upper arm, around the upper forearm) to achieve the desired effect, or even around a portion of the leg.

[0080] exist Figure 26 to Figure 27 In the wearable system 500", 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, 520z configured to be excited independently of each other. When the band 502 is attached to the wrist 38 of the user 42, as shown Fig. 27 As shown, common ground electrode 520m is located proximally, and each of the independent electrodes 520w-520z is located distally. Because they are independently connected relative to each other, the independent electrodes 520w-520z can operate in a wide range of different modes.

[0081] In alternative embodiments, the electrodes 520 and piezoelectric discs 536 may each have unequal numbers (e.g., six electrodes 520 and four piezoelectric discs 536, etc.) or equal numbers. Some pairs 566 may be present in some portions of the band 502, while single electrodes 520 or single piezoelectric discs 536 may be present in other portions of the band 502. Although the band 502 of the wearable blood pressure control system 500, 500', 500" is shown without an armband 416, in other embodiments, each of the wearable blood pressure control systems 500, 500', 500" may incorporate an armband 416 suitable for all sizes, or for blood pressure measurement, or for therapeutic compression. The electrode arrays 520 and piezoelectric discs 536 presented herein allow for multiple touch points on the skin or around a limb, which can result in a faster reduction in blood pressure.

[0082] In an alternative embodiment, the wearable blood pressure control system 600 is Fig.29 604 and includes a housing 602 (similar to housing 402) and a band 604. Band 604 has a bracelet-like structure including five separate flexible circuit segments 606a-606e. Each of the flexible circuit segments 606a-606e has a conductive trace 608 coupled to a component (e.g., an electrode, a piezoelectric element - not shown). In some embodiments, the component may be as shown in FIG. Fig.28 The hinge joint 610 between each adjacent flexible circuit segment 606a-606e includes one or more conductors 612 that electrically connect them together. In some embodiments, the hinge joint 610 may include an elastic matrix to allow some elastic separation and rebound (stretching) between adjacent flexible circuit segments 606a-606e. Fig.29 Five flexible circuit segments 606a-606e are shown, but any number may be used, for example, between three and sixteen or between four and ten. The low profile and lightweight structure of the flexible circuit segments 606a-606e, as well as the modular architecture and ease of manufacturing, increase affordability and allow for an easily wearable system.

[0083] Although the foregoing is directed to embodiments of the present invention, other and further embodiments of the present invention may be devised without departing from the basic scope of the present invention. Fig.14 The method described can also be used Fig.15 Wearable blood pressure control system 400, Figure 22 to Figure 23 Wearable blood pressure control system 500 and Fig.29 Wearable blood pressure control system 600.

[0084] A method for controlling blood pressure of a subject includes: providing a system for controlling blood pressure, the system including 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 the subject; a sensing module carried by the wearable interface and configured to at least determine a change in blood pressure of the first limb of the subject; and an energy application module carried by the wearable interface and configured to apply two or more types of energy to the first limb of the subject, placing the system on the patient's arm, measuring blood pressure with the system, and applying energy to the ulnar nerve of the subject with the system. In some embodiments, the measuring step is performed two or more times a day. In some embodiments, the measuring step is performed three or more times a day. In some embodiments, the applying step is performed two or more times a day. In some embodiments, the applying step is performed three or more times a day. In some embodiments, the method includes applying energy to one or more nerves of the subject other than the median nerve with the system. In some embodiments, the method includes applying energy to the right median nerve of the subject with the system. In some embodiments, the method includes applying energy to the left median nerve of the subject with the system. In some embodiments, the method includes placing the system at or near the subject's wrist.

[0085] A method for controlling a subject's blood pressure includes providing a system for controlling blood pressure, the system comprising: a wearable interface having an inner contact surface, the wearable interface configured to at least partially surround a first portion of a first limb of the subject; a sensing module carried by the wearable interface and configured to at least determine blood pressure changes in the first limb of the subject; and an energy application module carried by the wearable interface and configured to apply two or more types of energy to the first limb of the subject, placing the system on the patient's arm, measuring blood pressure with the system, and applying energy to the radial nerve of the subject with the system.

[0086] A method for controlling a subject's blood pressure includes providing a system for controlling blood pressure, the system comprising: a wearable interface having an inner contact surface, the wearable interface configured to at least partially surround a first portion of a first limb of the subject; a sensing module carried by the wearable interface and configured to at least determine blood pressure changes in the first limb of the subject; and an energy application module carried by the wearable interface and configured to apply two or more types of energy to the first limb of the subject, placing the system on the patient's arm, measuring blood pressure with the system, and applying energy to the subject's ulnar nerve with the system.

[0087] In some embodiments, any of these methods can include ceasing to apply energy when the patient's blood pressure has decreased.

[0088] The ranges disclosed herein also include any and all overlaps, sub-ranges, and combinations thereof. Languages ​​such as "up to," "at least," "greater than," "less than," "between" include the stated numbers. Terms such as "approximately," "about," and "substantially" used herein include the numbers listed (e.g., about 10%=10%), and also represent the amount of the stated amount that is close to still performing the desired function or achieving the desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount.

Claims

1. A system comprising: a wearable interface having an inner contact surface, the wearable interface configured to at least partially surround a first portion of a first limb of a subject; An energy application module, carried by the wearable interface and configured to apply two or more types of energy to the first limb of the subject, wherein the energy application module includes a plurality of flexible electrodes, and the flexible electrodes are configured to be operated so that the plurality of flexible electrodes exert a concentrated effect on the nerves of the first limb of the subject.

2. The system according to claim 1, further comprising: A sensing module is carried by the wearable interface and is configured to be proximate to the first portion of the first limb of the subject and to output signals for determining one or more cardiovascular parameters of the subject in the first limb.

3. The system according to claim 2, wherein: The one or more cardiovascular parameters include blood pressure.

4. The system according to claim 2, wherein: The one or more cardiovascular parameters include electrocardiogram data.

5. The system according to claim 1, wherein: The energy application module further comprises: Multiple piezoelectric elements.

6. The system according to any one of claims 1 to 5, wherein: The nerves of the first limb of the subject include nerves selected from the list consisting of: a median nerve, a radial nerve, or an ulnar nerve.

7. The system of claim 5, further comprising a flexible circuit carried by the wearable interface.

8. The system according to claim 7, wherein: The flexible circuit includes a flexible substrate, and wherein at least one of the plurality of flexible electrodes is carried on a first surface of the flexible substrate, and wherein at least one of the piezoelectric elements is carried on a second surface of the flexible substrate, the second surface being opposite to the first surface.

9. The system according to claim 8, wherein: At least one of the plurality of flexible electrodes and at least one of the plurality of piezoelectric elements comprise a layered pair.

10. The system of claim 9, further comprising a controller, and wherein: At least one flexible electrode of the plurality of flexible electrodes and at least one piezoelectric element of the plurality of piezoelectric elements are configured to operate in cooperation.

11. The system according to claim 8, wherein: The flexible substrate includes polyimide.

12. The system according to claim 8, wherein: At least one flexible electrode of the plurality of flexible electrodes is coupled to the first surface of the flexible substrate via a conductive paint.

13. The system according to claim 8, wherein: At least one piezoelectric element of the plurality of piezoelectric elements is coupled to the second surface of the flexible substrate using a conductive epoxy.

14. The system according to claim 5, wherein: The plurality of piezoelectric elements are embedded.

15. The system according to claim 5, wherein: The plurality of piezoelectric elements include piezoelectric disks.

16. The system according to claim 5, wherein: The plurality of flexible electrodes and the plurality of piezoelectric elements are arranged into a plurality of layered pairs of flexible electrodes and piezoelectric elements.

17. The system of claim 1, wherein: The wearable interface is configured to at least partially surround a leg of the subject.

18. The system of claim 1, wherein: At least one flexible electrode of the plurality of flexible electrodes includes a conductive hydrogel.

19. The system of claim 1, wherein: The plurality of flexible electrodes includes at least one stretchable electrode.

20. The system of claim 1, wherein: The wearable interface includes multiple flexible circuit portions coupled together.

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