The described embodiments relate generally to wearable devices. More particularly, the described embodiments relate to ambulatory blood pressure cuffs that can be worn around a limb of a user to, periodically or continuously, measure a blood pressure of the user during daily activities of the user.
A user may measure blood pressure by attaching a blood pressure measurement device to one of their limbs. The blood pressure measurement device may include an inextensible cuff that secures an inflatable bladder against a limb of the user. The inflatable bladder can be expanded, and the inextensible cuff may cause the bladder to compress the limb, thereby compressing one or more blood vessels in the limb and restricting and/or stopping (i.e., occluding) blood flow through the vessels. The various pressures in the inflatable bladder that restrict and/or stop blood flow through the vessels in the limb may be measured and used to determine the blood pressure of the user.
A blood pressure measurement device including a blood pressure cuff is typically worn during measurement of a blood pressure, and is removed promptly thereafter. In some cases, it might be desirable to wear the monitoring device for longer periods of time such that physiological measurements can be performed periodically or continuously.
The term embodiment and like terms, e.g., implementation, configuration, aspect, example, and option, are intended to refer broadly to all of the subject matter of this disclosure and the claims below. Statements containing these terms should be understood not to limit the subject matter described herein or to limit the meaning or scope of the claims below. Embodiments of the present disclosure covered herein are defined by the claims below, not this summary. This summary is a high-level overview of various aspects of the disclosure and introduces some of the concepts that are further described in the Detailed Description section below. This summary is not intended to identify key or essential features of the claimed subject matter. This summary is also not intended to be used in isolation to determine the scope of the claimed subject matter. The subject matter should be understood by reference to appropriate portions of the entire specification of this disclosure, any or all drawings, and each claim.
Embodiments of this disclosure are directed to a wearable blood pressure measurement device having an inner sleeve and a cuff module. The inner sleeve may be wearable on a limb of a user and having a first attachment mechanism. The cuff module may have a second attachment mechanism that is attachable to the first attachment mechanism. The cuff module may include a cuff configured for placement over the inner sleeve, a bladder assembly having one or more bladders configured to expand and contract in response to a flow of a fluid (e.g., one or more gases (e.g., air) or liquids (e.g., oil)) therethrough, and a controller. The controller may be configured to measure a blood pressure of the user while controlling expansion and contraction of the one or more bladders.
Embodiments of this disclosure are also directed to a wearable device having an inner sleeve and a measurement module. The inner sleeve may be wearable on a limb of a user. The measurement module may be removably coupled to the inner sleeve. The measurement module may include one or more sensors, a controller, and a power delivery system. The controller may be in communication with the one or more sensors and configured to measure one or more health parameters of the user using the one or more sensors. The power delivery system may be configured to supply power to the one or more sensors and the controllers.
Embodiments of this disclosure are also directed to a wearable device for attachment to a limb of a user. The wearable device may include an elongate strap having a first end and a second end, a fold between the first end and the second end in the elongate strap, and a sizing mechanism. The sizing mechanism may allow the fold to open after the elongate strap is attached to the user, such that a portion of the elongate strap is released as slack to accommodate the limb of the user.
The above summary is not intended to represent each embodiment or every aspect of the present disclosure. Rather, the foregoing summary merely provides an example of some of the novel aspects and features set forth herein. The above features and advantages, and other features and advantages of the present disclosure, will be readily apparent from the following detailed description of representative embodiments and modes for carrying out the present invention, when taken in connection with the accompanying drawings and the appended claims. Additional aspects of the disclosure will be apparent to those of ordinary skill in the art in view of the detailed description of various embodiments, which is made with reference to the drawings, a brief description of which is provided below.
The disclosure will be readily understood by the following detailed description in conjunction with the accompanying drawings, wherein like reference numerals designate like structural elements, and in which:
The use of cross-hatching or shading in the accompanying figures is generally provided to clarify the boundaries between adjacent elements and also to facilitate legibility of the figures. Accordingly, neither the presence nor the absence of cross-hatching or shading conveys or indicates any preference or requirement for particular materials, material properties, element proportions, element dimensions, commonalities of similarly illustrated elements, or any other characteristic, attribute, or property for any element illustrated in the accompanying figures.
The present disclosure is susceptible to various modifications and alternative forms, and some representative embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Additionally, it should be understood that the proportions and dimensions (either relative or absolute) of the various features and elements (and collections and groupings thereof) and the boundaries, separations, and positional relationships presented therebetween, are provided in the accompanying figures merely to facilitate an understanding of the various embodiments described herein and, accordingly, may not necessarily be presented or illustrated to scale, and are not intended to indicate any preference or requirement for an illustrated embodiment to the exclusion of embodiments described with reference thereto.
Various embodiments are described with reference to the attached figures, where like reference numerals are used throughout the figures to designate similar or equivalent elements. The figures are not necessarily drawn to scale and are provided merely to illustrate aspects and features of the present disclosure. Numerous specific details, relationships, and methods are set forth to provide a full understanding of certain aspects and features of the present disclosure, although one having ordinary skill in the relevant art will recognize that these aspects and features can be practiced without one or more of the specific details, with other relationships, or with other methods. In some instances, well-known structures or operations are not shown in detail for illustrative purposes. The various embodiments disclosed herein are not necessarily limited by the illustrated ordering of acts or events, as some acts may occur in different orders and/or concurrently with other acts or events. Furthermore, not all illustrated acts or events are necessarily required to implement certain aspects and features of the present disclosure.
For purposes of the present detailed description, unless specifically disclaimed, and where appropriate, the singular includes the plural and vice versa. The word “including” means “including without limitation.” Moreover, words of approximation, such as “about,” “almost,” “substantially,” “approximately,” and the like, can be used herein to mean “at,” “near,” “nearly at,” “within 3-5% of,” “within acceptable manufacturing tolerances of,” or any logical combination thereof. Similarly, terms “vertical” or “horizontal” are intended to additionally include “within 3-5% of” a vertical or horizontal orientation, respectively.
Additionally, directional terminology, such as “top”, “bottom”, “upper”, “lower”, “front”, “back”, “over”, “under”, “above”, “below”, “left”, “right”, etc. is used with reference to the orientation of some of the components in some of the figures described below. Because components in various embodiments can be positioned in a number of different orientations, directional terminology is used for purposes of illustration only and is in no way limiting. The directional terminology is intended to be construed broadly, and therefore should not be interpreted to preclude components being oriented in different ways. These words are intended to relate to the equivalent direction as depicted in a reference illustration; as understood contextually from the object(s) or element(s) being referenced, such as from a commonly used position for the object(s) or element(s); or as otherwise described herein. Further, it is noted that the term “signal” means a waveform (e.g., electrical, optical, magnetic, mechanical or electromagnetic) capable of traveling through a medium such as DC, AC, sinusoidal-wave, triangular-wave, square-wave, vibration, and the like.
Also, as used herein, the phrase “at least one of” preceding a series of items, with the term “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list. The phrase “at least one of” does not require selection of at least one of each item listed; rather, the phrase allows a meaning that includes at a minimum one of any of the items, and/or at a minimum one of any combination of the items, and/or at a minimum one of each of the items. By way of example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and/or one or more of each of A, B, and C. Similarly, it may be appreciated that an order of elements presented for a conjunctive or disjunctive list provided herein should not be construed as limiting the disclosure to only that order provided.
Embodiments of the disclosure relate to devices and systems having ambulatory blood pressure cuffs that can be worn around a limb (e.g., an arm) of a user to, periodically or continuously, measure blood pressure of the user during daily activities of the user. Consistent positioning of a blood pressure cuff is necessary for accurate and consistent measurement of blood pressure during any sort of activity the user may perform during the day. This may be affected by different movements of the user and associated vibrations. The devices and systems described herein address different ways in which a blood pressure cuff can be held at a fixed position on the user's body for blood pressure measurement.
According to embodiments described herein, the device may have an inner sleeve coupled to a cuff module that includes a controller and the blood pressure cuff. The inner sleeve may be easily securable to, and removable from, an arm of a user. The cuff module may include a bladder assembly having one or more bladders that are controllably operated by the controller, and may include a sizing mechanism that enables the blood pressure cuff to maintain a particular tightness around the arm of the user. Advantageously, the blood pressure cuff may be designed to be donned and doffed easily, as well as comfortably worn during daily activities, to continuously measure blood pressure of the user. Further, the sizing mechanisms included on the cuff module may allow the user to repeatedly size the blood pressure cuff to their arm with a maximum allowable extra volume that allows for arm flexure, but without impacting measurement accuracy.
The cuff module 104, as further described in
A first attachment mechanism 202 may extend from the outer surface 201 of the inner sleeve 102. The first attachment mechanism 202 may be attachable to a second attachment mechanism 206 on the controller 106 of the cuff module 104, and may be used to maintain the blood pressure cuff 105 in position over the inner sleeve 102. In some embodiments, and as shown in
In different embodiments, the first attachment mechanism 202 and the second attachment mechanism 206 may include magnetic attachments or mechanical linkages, to attach the cuff module 104 to, and over, the inner sleeve 102.
As shown in
The controller 106 may include a reservoir, a pump, and a power delivery system (e.g., a battery, and conductors to route power delivered by the battery to other components of the controller 106). The controller 106 may pump fluid from the reservoir into the fluid channel through operation of the pump. In some embodiments, the pump may be an ultrasonic pump. The controller 106 may be configured to measure a blood pressure of the user using the one or more sensors of the sensor(s) 225, while controlling expansion and contraction of the bladder(s) in the bladder assembly 210. The power delivery system may deliver power for operating the pump, the sensor(s), and circuitry within the controller 106.
In some embodiments, and as shown in
The elongate strap 215 may have a fold 260 between the first end 252 and the second end 254. The fold 260 may extend along a width of the elongate strap 215. A sizing mechanism 108 allows the fold 260 to open after the elongate strap 215 is wrapped around a user's arm. The sizing mechanism 108 allows the fold 260 to open just enough to release a portion of the elongate strap 215 as slack to accommodate the arm of the user. In some embodiments, the sizing mechanism 108 may include a hook-and-loop fastener, respective complementary portions of which may separate during flexure of a user's arm or expansion of the bladder assembly 210. In other embodiments, the sizing mechanism 108 may include a magnetic attachment, portions of which may separate during flexure of a user's arm or expansion of the bladder assembly 210. In yet other embodiments, the sizing mechanism 108 may include a mechanical linkage (e.g., a linkage having a spring or elastic member that provides slack when a user's arm is flexed).
In some embodiments, the bladder assembly 210 may be expandable and can be operated to transition between an expanded state and a contracted state. The bladder(s) of the bladder assembly 210 may contain a fluid (e.g., air or oil) and be configured to expand and contract in response to an inward or outward flow of the fluid. A fluid channel may extend between the bladder assembly 210 and a reservoir, which reservoir may contain at least a portion of the fluid when the bladder(s) of the bladder assembly 210 are contracted. Alternatively, in the case of a pneumatic bladder system, fluid (e.g., air) may be pulled from and released into an ambient environment and the reservoir may not be provided. The fluid channel may couple the bladder assembly 210 to the reservoir such that fluid can move between the bladder assembly 210 and the reservoir. In some embodiments, the combined fluid volume in the bladder assembly 210, the fluid channel, and the reservoir may be constant. Accordingly, the volume of fluid in the bladder assembly 210 and the reservoir may be inversely related as fluid moves between these two components. For example, fluid can move from the bladder assembly 210, through the fluid channel, and to the reservoir, thereby decreasing the fluid volume in the bladder assembly 210 and increasing the fluid volume in the reservoir.
The bladder assembly 210 may include a length that extends around at least a portion of the circumference of the blood pressure cuff 105 (i.e., around a user's arm) and a thickness that extends from an interior of the blood pressure cuff 105 to an exterior of the blood pressure cuff 105 (transverse to the length). The bladder assembly 210 can be configured such that when it is empty (or nearly empty), the bladder(s) are collapsed. As the bladder assembly 210 is filled with fluid from the reservoir, the volume of the bladder(s) may increase, thereby increasing the thickness of the bladder assembly 210. In some embodiments, the bladder assembly 210 may be formed from a first sheet and a second sheet that are coupled together at defined locations to form the bladder(s). The portions where the first and second sheets are coupled may form sections of the bladder assembly 210 that are impermeable to fluid, and the portions of the first and second sheets that are not coupled may define the bladder(s) and separate/move relative to each other.
The pump may be configured to control a flow of fluid between the reservoir and the bladder assembly 210, thereby switching the bladder assembly 210 between the expanded state and the contracted state. In some embodiments, the pump may include a valve to switchably control the flow of fluid.
In the contracted state, as the user's limb expands, fluid may move from the bladder assembly 210 into the reservoir, thereby allowing the bladder(s) to contract. Also, in the contracted state, the bladder assembly 210 can decrease in size. For example, as a user moves or flexes their arm, fluid can move from the bladder assembly 210 into the reservoir.
In the expanded state, the pump may move fluid into the bladder(s) and then prevent the movement of fluid between the bladder assembly 210 and the reservoir. Since fluid cannot move into or out of the bladder assembly 210, the volume of fluid in the bladder(s) may remain constant. While the bladder assembly 210 is in the expanded state, or as the bladder assembly 210 is expanding toward, or contracting from, the expanded state, one or more sensors of the sensor(s) 225 can be used by the controller 106 to measure a blood pressure of the user. The expanded state of the bladder assembly 210 may make the blood pressure cuff 105 inextensible such that during the blood pressure measurement, the sensors 225 primarily expand toward and compress an arm of a user.
The wearable device 100 may be worn in a way that stabilizes the integrated electronic components in the controller 106 and the blood pressure cuff 105 through a stabilizing component that keeps the wearable device 100 from slipping or rotating from the ideal measurement location on the user's arm.
As further shown in
The wearable device 100 may include a sizing mechanism 108 attached to the cuff module 104, and more particularly to the blood pressure cuff 105. The sizing mechanism 108 may provide slack in the blood pressure cuff 105, which slack allows the user's arm to flex comfortably while wearing the cuff module 104, while maintaining the blood pressure cuff 105 with sufficient tightness around the arm to effectively occlude an artery in the user's arm and measure the user's blood pressure.
The processor 702 can control some of all of the operations of the wearable device 700. The processor 702 can communicate, either directly or indirectly, with some or all of the components of the wearable device 700. For example, a system bus or other communication mechanism 718 can provide communication between the processor 702, the memory 704, the power delivery system 706, the input/output (I/O) mechanism 708, the pump 710, one or more valves 712, one or more sensors 714, and the display 716.
The processor 702 can be implemented as any electronic device capable of processing, receiving, or transmitting data or instructions. For example, the processor 702 can be a microprocessor, a central processing unit (CPU), an application-specific integrated circuit (ASIC), a digital signal processor (DSP), or combinations of such devices. As described herein, the term “processor” is meant to encompass a single processor or processing unit, multiple processors, multiple processing units, or other suitable computing element or elements.
It should be noted that the components of the wearable device 700 can be controlled by multiple processors. For example, selected components of the wearable device 700 (e.g., a sensor 714) may be controlled by a first processor and other components of the wearable device 700 (e.g., the display 716) may be controlled by a second processor, where the first and second processors may or may not be in communication with each other.
The memory 704 can store electronic data that can be used by the wearable device 700. For example, the memory 704 can store electrical data or content such as, for example, applications, device settings and user preferences, timing signals, control signals, and data structures or databases. The memory 704 can be configured as any type of memory. By way of example only, the memory 704 can be implemented as random access memory, read-only memory, Flash memory, removable memory, other types of storage elements, or combinations of such devices.
The power delivery system 706 can be implemented with any device capable of providing energy to the wearable device 700. For example, the power delivery system 706 may include one or more batteries or rechargeable batteries. Additionally or alternatively, the power delivery system 706 can include a power connector or power cord that connects the wearable device 700 to another power delivery system, such as a wall outlet.
The 110 mechanism 708 can transmit and/or receive data from a user or another electronic device. An 110 mechanism 708 can include a display, a touch sensing input surface, one or more buttons (e.g., a graphical user interface “home” button), one or more cameras, one or more microphones or speakers, one or more ports, such as a microphone port, and/or a keyboard. Additionally or alternatively, an 110 device or port can transmit electronic signals via a communications network, such as a wireless and/or wired network connection. Examples of wireless and wired network connections include, but are not limited to, cellular, Wi-Fi, Bluetooth, IR, and Ethernet connections.
The wearable device 700 can also include a pump 710 that is used to inflate the bladder. The pump 710 can be an air pump such as an ultrasonic air pump, diaphragm pump, and so on. The pump 710 can be powered by the power delivery system 706 and controlled by the processor 702. The pump 710 may be capable of inflating the bladder to pressures that are above typical human blood pressures such as up to or higher than 180 mm Hg. In some cases, the pump 710 can be configured to apply a linear or smooth pressure ramp within the bladder. The pump 710 can also be configured to provide a linear, or constant, pressure release within the bladder, which may be used to acquire blood pressure measurements during deflation of the cuff.
The wearable device 700 can also include one or more valves 712 that fluidly couple the pump 710 to a bladder. The valves 712 can be passive valves, such as diaphragm valves described herein. In some cases, the valves 712 can be electronically controlled valves such as a solenoid actuated valve. In this regard, the electronically controlled valve can be electrically coupled to the processor 702 such that operation of the valves 712 is controlled by the processor 702.
The wearable device 700 may also include one or more sensors 714 positioned almost anywhere on the wearable device 700. The sensor(s) 714 can be configured to sense one or more types of parameters, such as but not limited to, pressure, sound, light, touch, heat, movement, relative motion, biometric data (e.g., biological parameters), and so on. For example, the sensor(s) 714 may include a pressure sensor, an auditory sensor, a heat sensor, a position sensor, a light or optical sensor, an accelerometer, a pressure transducer, a gyroscope, a magnetometer, a health monitoring sensor, and so on. Additionally, the one or more sensors 714 can utilize any suitable sensing technology, including, but not limited to, capacitive, ultrasonic, resistive, optical, ultrasound, piezoelectric, and thermal sensing technology.
The wearable device 700 may also, optionally, include the display 716. The display 716 may include a liquid-crystal display (LCD), organic light emitting diode (OLED) display, light emitting diode (LED) display, or the like. If the display 716 is an LCD, the display 716 may also include a backlight component that can be controlled to provide variable levels of display brightness. If the display 716 is an OLED or LED type display, the brightness of the display 716 may be controlled by modifying the electrical signals that are provided to display elements. The display 716 may correspond to any of the displays shown or described herein.
The foregoing description, for purposes of explanation, uses specific nomenclature to provide a thorough understanding of the described embodiments. However, it will be apparent to one skilled in the art, after reading this description, that the specific details are not required in order to practice the described embodiments. Thus, the foregoing descriptions of the specific embodiments described herein are presented for purposes of illustration and description. They are not targeted to be exhaustive or to limit the embodiments to the precise forms disclosed. It will be apparent to one of ordinary skill in the art, after reading this description, that many modifications and variations are possible in view of the above teachings.
As described above, one aspect of the present technology may be the gathering and use of data available from various sources, including biometric data. The present disclosure contemplates that, in some instances, this gathered data may include personal information data that uniquely identifies or can be used to identify, locate, or contact a specific person. Such personal information data can include, for example, biometric data and data linked thereto (e.g., demographic data, location-based data, telephone numbers, email addresses, home addresses, data or records relating to a user's health or level of fitness (e.g., vital signs measurements, medication information, exercise information), date of birth, or any other identifying or personal information).
The present disclosure recognizes that the use of such personal information data, in the present technology, can be used to the benefit of users. For example, the personal information data can be used to authenticate a user to access their device, or gather performance metrics for the user's interaction with an augmented or virtual world. Further, other uses for personal information data that benefit the user are also contemplated by the present disclosure. For instance, health and fitness data may be used to provide insights into a user's general wellness, or may be used as positive feedback to individuals using technology to pursue wellness goals.
The present disclosure contemplates that the entities responsible for the collection, analysis, disclosure, transfer, storage, or other use of such personal information data will comply with well-established privacy policies and/or privacy practices. In particular, such entities should implement and consistently use privacy policies and practices that are generally recognized as meeting or exceeding industry or governmental requirements for maintaining personal information data private and secure. Such policies should be easily accessible by users, and should be updated as the collection and/or use of data changes. Personal information from users should be collected for legitimate and reasonable uses of the entity and not shared or sold outside of those legitimate uses. Further, such collection/sharing should occur after receiving the informed consent of the users. Additionally, such entities should consider taking any needed steps for safeguarding and securing access to such personal information data and ensuring that others with access to the personal information data adhere to their privacy policies and procedures. Further, such entities can subject themselves to evaluation by third parties to certify their adherence to widely accepted privacy policies and practices. In addition, policies and practices should be adapted for the particular types of personal information data being collected and/or accessed and adapted to applicable laws and standards, including jurisdiction-specific considerations. For instance, in the US, collection of or access to certain health data may be governed by federal and/or state laws, such as the Health Insurance Portability and Accountability Act (HIPAA); whereas health data in other countries may be subject to other regulations and policies and should be handled accordingly. Hence different privacy practices should be maintained for different personal data types in each country.
Despite the foregoing, the present disclosure also contemplates embodiments in which users selectively block the use of, or access to, personal information data. That is, the present disclosure contemplates that hardware and/or software elements can be provided to prevent or block access to such personal information data. For example, in the case of advertisement delivery services, the present technology can be configured to allow users to select to “opt in” or “opt out” of participation in the collection of personal information data during registration for services or anytime thereafter. In another example, users can select not to provide data to targeted content delivery services. In yet another example, users can select to limit the length of time data is maintained or entirely prohibit the development of a baseline profile for the user. In addition to providing “opt in” and “opt out” options, the present disclosure contemplates providing notifications relating to the access or use of personal information. For instance, a user may be notified upon downloading an app that their personal information data will be accessed and then reminded again just before personal information data is accessed by the app.
Moreover, it is the intent of the present disclosure that personal information data should be managed and handled in a way to minimize risks of unintentional or unauthorized access or use. Risk can be minimized by limiting the collection of data and deleting data once it is no longer needed. In addition, and when applicable, including in certain health related applications, data de-identification can be used to protect a user's privacy. De-identification may be facilitated, when appropriate, by removing specific identifiers (e.g., date of birth, etc.), controlling the amount or specificity of data stored (e.g., collecting location data at a city level rather than at an address level), controlling how data is stored (e.g., aggregating data across users), and/or other methods.
Therefore, although the present disclosure broadly covers use of personal information data to implement one or more various disclosed embodiments, the present disclosure also contemplates that the various embodiments can also be implemented without the need for accessing such personal information data. That is, the various embodiments of the present technology are not rendered inoperable due to the lack of all or a portion of such personal information data. For example, content can be selected and delivered to users by inferring preferences based on non-personal information data or a bare minimum amount of personal information, such as the content being requested by the device associated with a user, other non-personal information available to the content delivery services, or publicly available information.
Although the disclosed embodiments have been illustrated and described with respect to one or more implementations, equivalent alterations and modifications will occur or be known to others skilled in the art upon the reading and understanding of this specification and the annexed drawings. In addition, while a particular feature of the invention may have been disclosed with respect to only one of several implementations, such feature may be combined with one or more other features of the other implementations as may be desired and advantageous for any given or particular application.
While various embodiments of the present disclosure have been described above, it should be understood that they have been presented by way of example only, and not limitation. Numerous changes to the disclosed embodiments can be made in accordance with the disclosure herein, without departing from the spirit or scope of the disclosure. Thus, the breadth and scope of the present disclosure should not be limited by any of the above described embodiments. Rather, the scope of the disclosure should be defined in accordance with the following claims and their equivalents.
This application is a nonprovisional of, and claims the benefit under 35 U.S.C. § 119(e) of, and priority to U.S. Provisional Patent Application No. 63/238,701, filed Aug. 30, 2021, the contents of which are incorporated herein by reference in its entirety.
Number | Date | Country | |
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63238701 | Aug 2021 | US |