Cardiovascular disease (CVD) accounts for approximately a significant number of deaths on a world-wide basis. CVD includes coronary heart disease (CHD), which accounts for the majority of CVD deaths, as well as stroke and heart failure. Many more individuals carry a diagnosis of CVD and live with the diagnosis. Those living with CVD are at risk of acute heart attack, strokes and other chronic conditions that can adversely affect the individual's quality of live over a long term long-term. Ultimately, CVD increases the risks of mortality in the patient. Therefore, there is a keen interest by governments, healthcare providers, as well as the general population to prevent CVD.
The rise of portable smart-devices, such as smart phones, smart watches, fitness monitors, etc. has given individuals a useful tool to monitor health parameters to address CVD symptoms, where such health parameters include blood pressure and heart rate. Such devices are also of interest to healthy individuals so that who can monitor such data to avoid the onset or progression of CVD. In addition, a number of drugs or therapeutic strategies treat or manipulate the cardiovascular diseases. As a result, predicting short-term and long-term risk of cardiovascular diseases for people plays an important role in treatment. To this end, although pathogenesis of different cardiovascular diseases might be distinct from each other, most of them can be monitored and precautionary assessed through specific physical signs. Since most cardiovascular diseases including hypertension diseases and hypotension diseases are significantly related to blood pressures and such monitoring techniques thereof are not well-developed and implemented universal, there is a need to establish or develop a monitoring device or a monitoring method for monitoring blood pressures in households or hospitals in a simpler manner.
Non-invasive blood pressure measuring devices including sphygmomanometers and photoplethysmography are used in monitoring patient's blood pressures to prevent various cardiovascular diseases or provide doctors with early diagnosis. However, most of them are bulky and heavy which are inconvenient for outdoor applications and long-time monitoring.
Furthermore, a need remains for a device to monitor blood pressure but avoids discomfort for patients.
Previously, wearable blood-pressure monitoring devices that allowed for real-time monitoring and portable capability are described in US20180049655 and WO2018005298, the entirety of each of which is incorporated by reference. However, there remains a need to more accurately measure blood pressure using a portable, non-obtrusive device.
The present disclosure includes a force detecting device that uses elastomeric polymers to determine application of a force applied to the device. In one variation, the present disclosure includes devices for detecting a force in a surface region of tissue. For example, the device can include a transparent backing material comprising a planar shape, the transparent backing material comprising a first surface and a second surface on an opposite side of the planar shape; a first elastomer on the first surface of the transparent backing material, where a light transmission property of the first elastomer changes upon application of force to the first elastomer; and wherein when positioned on the surface region of tissue the force in the surface region causes a deformation of the first elastomer resulting in a change in the light transmission property of the first elastomer. In additional variations of the device, the transparent backing material is optional and can be replaced with a device body.
The configuration described herein using polymers and optical devices allows for the optical devices to be monolithically integrated into a chip, allowing further miniaturization of the device. The configuration of the device allows for the optical devices could to be a camera module of a smart phone, allowing the user to measure their own blood pressure on demand. The configuration also allows this measurement method to be applied on other portions of a body rather than just on a digit.
Variations of the device can further include a second elastomer on the first surface of the transparent backing material, where a light transmission property of the second elastomer changes upon application of force to the first elastomer; an opaque divider between the first elastomer and the second elastomer to block propagation of light therebetween; a stiffening layer on the second elastomer on a side opposite to the transparent backing material; and wherein when positioned on the surface region the stiffening layer prevents the force from changing the light transmission property of the second elastomer such that the second elastomer provides a reference to determine a deformation of the first elastomer.
A variation of the device further includes an opaque cover on the first elastomer and the second elastomer located on the side opposite to the transparent backing material, where the stiffening layer is located on the opaque layer and adjacent to the second elastomer.
Another variation of the invention includes an opaque cover on the first elastomer and the second elastomer located on the side opposite to the transparent backing material, where the stiffening layer is located on the second elastomer and opaque layer and adjacent to the opaque cover. Variations of the device can include a stiffening layer, additive, or reinforcement on any portion of the elastomers.
The device further include a light emitting source and a light detecting element both located adjacent to the first elastomer and to the second elastomer, where the light emitting source is configured to illuminate the first elastomer and second elastomer and where the light detecting element is configured to determine an absorption of light in the first elastomer and in the second elastomer.
Another variation of the device includes the light detecting element being configured to transmit a signal to a controller, where the signal comprises data of the absorption of light in the first elastomer and in the second elastomer to determine the force in the surface region.
The present disclosure also includes method of measuring a blood pressure in an artery within a region of tissue. The measurements can be continuous over a period of time or on demand. In one example, the method includes positioning an assembly adjacent to the region of tissue, where the assembly comprises a first polymer configured to alter a light transmission property upon application of force to the polymer, where deformation of the region of tissue causes deformation of the first polymer; illuminating the first polymer; observing an emission of light from the first polymer during application of a force on the first polymer where the force is produced by the artery; and determining a change in the emission of light caused by application of the force to calculate a blood pressure in the artery.
A variation of the method can include an assembly having a second elastomer, where the second polymer is configured such that deformation of the region of tissue does not cause deformation of the second polymer. The method can include illuminating the second polymer during illuminating of the first polymer.
A variation of the method further includes observing an emission of light from the second polymer during application of the force on the first polymer.
The methods can include comparing the emission of light of the first polymer to the emission of light from the second polymer.
The methods described herein can be performed on a region of tissue such as a digit, an arm, a leg, or any body part where measurement of tissue displaced by blood flow in an artery occurs.
The methods and device discussed herein can transmit the blood pressure information via a wired or wireless connection to any personal electronic device including but not limited to a smart phone, a smart watch, a fitness tracker, a tablet, a computer, and/or a network.
The methods and devices can also continuously illuminate the first polymer for a period of time to continuously calculate the blood pressure in the artery over the period of time.
Another variation of the devices described herein include a patch that converts external forces into change of light absorption, comprising: a transparent backing; a light-absorptive sensing elastomer on one surface of the transparent backing, wherein: the light absorption of the light-absorptive sensing elastomer is indicative of the elastomer deformation subjected to static and fluctuating external forces.
The patch can further include an opaque cover on the surface, opposite to the interface between the transparent backing and the light-absorptive sensing elastomer, of the light-absorptive sensing elastomer.
A variation of the patch further includes a light-absorptive reference elastomer on the surface of the transparent backing and by one side of the light-absorptive sensing elastomer, wherein: the light absorption of the light-absorptive reference elastomer is indicative of the elastomer deformation subjected to static external forces.
The patch can also include an opaque divider that prohibits light propagation between the light-absorptive reference elastomer and the light-absorptive sensing elastomer.
Additional variations of the patch include an opaque cover on the surface, opposite to the interface between the transparent backing and the light-absorptive sensing elastomer, of the light-absorptive sensing elastomer and the light-absorptive reference elastomer.
The present disclosure also includes methods to measure blood pressure. For example, such a method can include attaching a patch, that converts external forces into change of light absorption, on the skin under which an artery passes through; emitting at least a light into the patch; measuring the lights propagating out from the patch; and converting the measurement of the lights, propagating out from the patch, into blood pressure.
The disclosure also includes variations of continuous blood pressure monitoring systems. For example, such systems include a patch that converts external forces into change of light absorption; a light emitter that emits at least a light into the patch; a light detector that measures the lights propagating out from the patch; and an algorithm that converts the measurement of the lights, propagating out from the patch, into blood pressure.
A variation of the continuous blood pressure monitoring system includes a transparent backing; and a light-absorptive sensing elastomer on one surface of the transparent backing, wherein: the light absorption of the light-absorptive sensing elastomer is indicative of the elastomer deformation subjected to static and fluctuating external forces.
The present disclosure also includes wearable devices that continuously monitor blood pressure. Such devices include a ring body; a light emitter disposed on a monitoring surface at the inner side of the ring body; a light detector disposed on a monitoring surface at the inner side of the ring body and by a side of the light emitter; and a light-absorptive sensing elastomer covering the light emitter and the detector, wherein: the light absorption, which is measured by the light detector, of the light-absorptive sensing elastomer is indicative of the blood pressure of a wearer.
Another example of a wearable device that continuously monitors blood pressure, includes a ring body; a light emitter disposed on a monitoring surface at the inner side of the ring body; a light detector disposed on a monitoring surface at the inner side of the ring body and by a side of the light emitter; a light-absorptive sensing elastomer covering a portion of the light emitter and a portion of the detector; and a light absorptive reference elastomer covering the remaining portion of the light emitter and the remaining portion of the detector; wherein: the comparative light absorption, which is measured by the light detector, of the light-absorptive sensing elastomer and the light-absorptive reference elastomer is indicative of the blood pressure of a wearer.
Methods and devices are described herein that relate to monitoring blood pressure in a vessel of a region of tissue. The methods and devices described herein can monitor blood pressure in a digit of a hand or in other areas of the body where the pulsatile flow of blood in a vessel displaces adjacent tissue that can be detected from a surface of the tissue. In addition, the methods and devices disclosed herein include improvements for detecting movement in a tissue of a region of the body, where the movement in the tissue arises from blood pressure changes within a vessel in that tissue. Optionally, the devices and methods described herein can be used wearable devices and non-invasive monitoring blood-pressure in real-time.
In this variation of the device 150, the first surface 156 of the transparent backing material 154 is positioned facing tissue while the second surface 158 is opposite to the first surface 156 and faces away from tissue. The transparent backing material 154 can also be malleable or shaped to conform to a surface for measuring deflection of that surface.
Variations of the transparent backing materials include, but are not limited to: silicone rubber, polycarbonate, PDMS, polyethylene terephthalate, polyethylene, PMMA, gelatin, hydrogel, polymer-dispersed liquid crystal, amorphous copolyester, polyvinyl chloride, cyclic olefin copolymers, ionomer resin, polypropylene, fluorinated ethylene propylene, styrene methyl methacrylate. The first/second polymer materials: same as above and their composites or nanocomposites by adding nanomaterials made of titanium oxides, silicon oxides, cavities, or others
Although the above example illustrates a second elastomer or reference elastomer, variations of the device 150 can omit this reference elastomer and determine an applied force by monitoring changes in a single elastomer.
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Well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the described devices. As those skilled in the art would realize, the described embodiments may be modified in various different ways, all without departing from the spirit or scope of the present invention. It should be noted that, without conflict, in the embodiment of the present invention and examples of features can be combined with each other. Therefore, it should be appreciated that the embodiments described herein are not intended to be exhaustive of all possible embodiments in accordance with the present disclosure, and that additional embodiments may be conceived based on the subject matter disclosed herein.
This application is a continuation of International Patent Application No. PCT/US2019/034856 filed May 31, 2019, which claims priority to U.S. Provisional Patent Application No. 62/679,435 filed Jun. 1, 2018, the contents of which are incorporated herein by reference in their entireties.
Number | Date | Country | |
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62679435 | Jun 2018 | US |
Number | Date | Country | |
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Parent | PCT/US2019/034856 | May 2019 | US |
Child | 17106631 | US |