Measuring system with controlled pressure ramp

Abstract

A measurement system and a method for manufacturing the same may include: a pressure-resistant structure; a pressure trigger, which is connected to the pressure-resistant structure, the pressure trigger having an engagement configuration, and the engagement configuration of the pressure trigger increases the pressure applied to the part of the user that contacts the pressure-resistant structure; a light source, which is connected to the pressure-resistant structure; an optical sensor, which is connected to the pressure-resistant structure and is configured to detect a signal from the light source; a pressure sensor, which is connected to the pressure-resistant structure, and is configured to detect the pressure applied to the part of the user that contacts the pressure trigger; and a processor, which is connected to the optical sensor and the pressure sensor, and is configured to associate volume data from the optical sensor with pressure data from the pressure sensor and provide a blood pressure measurement value.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The present invention claims the benefit of priority to all common subject matter of U.S. Provisional Patent Application No. 62 / 897,639, filed on September 9, 2019. The contents of that application are incorporated herein by reference in their entirety. Technical Field

[0003] The present disclosure relates to electronic physiological measurement systems, and more particularly, to measurement systems that utilize pressure inducers to achieve a controlled pressure ramp in blood pressure measurement. Background Art

[0004] The rapidly growing market for portable, wearable electronic devices represents one of the largest potential market opportunities for next-generation biosensors. These devices have unique attributes that significantly impact their design and manufacturing, as they must typically be small, lightweight, feature-rich, and they must be produced in large volumes at relatively low cost.

[0005] An extension of the portable wearable electronics industry is the biosensor industry, which includes optical sensors used to measure, for example, heart rate, blood pressure, and peripheral blood oxygen. Similar to the portable wearable electronics industry, the biosensor industry is also facing increasing commercial competition pressure, as well as rising consumer expectations and reduced opportunities for meaningful product differentiation in the market.

[0006] Sensor system size, sensor system design, and sensor system materials are core technologies for the next generation of biosensors that are being developed. These next generation biosensors are outlined in the roadmap for next generation product development. Competitive next generation sensor systems should improve signal to noise ratio, reduce cost, and operate with improved sensor performance. Importantly, for some industries including wearable rings and watches, it is critical to enable new types of measurements with smaller form factors and reduced power requirements.

[0007] As consumer products continue to be released, many approaches have emerged to meet the advanced requirements of biosensor systems and optical sensor systems. Many industry roadmaps have clearly pointed out the significant gap between current sensor capabilities and the design requirements of future products.

[0008] With the development of biosensor systems in the wearable electronics market, many measurement systems are being incorporated into applications that utilize sensors onboard electronic devices. Although measurement systems incorporated into electronic devices can provide many advantages in terms of cost, time, convenience, and expanded measurement sets, many limitations still exist.

[0009] Illustratively, for example, the measurement of blood pressure was once limited to trained professionals who could utilize an arm-mounted blood pressure cuff. Today, the measurement of blood pressure has been incorporated into applications utilizing sensors onboard electronic devices. One prior method of blood pressure monitoring is oscillometric pressure. This method utilizes an onboard photodetector and strain gauge array to estimate blood pressure.

[0010] The main limitation of finger pressure method is the controlled pressure input. Controlled pressure input can be crucial for accurate blood pressure measurement. In finger pressure method, the pressure input is completely up to the user, which can lead to many inconsistent and difficult to understand data.

[0011] As consumer electronic devices evolve and more physiological data is utilized and incorporated into medical and sports applications, the pressure to push the limits of technology becomes increasingly challenging. More importantly, as complexity continues to increase, the potential risk of errors in the manufacturing process increases significantly.

[0012] Finding answers to these questions is critical given the growing competitive pressures on business, as well as increasing consumer expectations and diminishing opportunities for meaningful product differentiation in the marketplace. Additionally, the need to reduce costs, decrease production time, improve efficiency and performance, and meet competitive pressures makes the critical necessity of finding answers to these questions even more urgent.

[0013] Therefore, there remains a need for a measurement system that can combine consistent pressure input at low cost and low power requirements. Solutions to these problems have been sought, but prior developments have not taught or suggested any complete solutions, and therefore, solutions to these problems have long eluded those skilled in the art. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] A measurement system with a controlled pressure ramp is illustrated in the accompanying drawings, which are intended to be illustrative and not limiting, in which like reference numerals are intended to indicate like parts, and in which:

[0015] Figure 1 is a top isometric view of the measurement system in the first embodiment.

[0016] Figure 2 yes Figure 1 Bottom isometric view of the measurement system.

[0017] Figure 3 yes Figure 1 Side view of the pressure initiator in the released configuration.

[0018] Figure 4 yes Figure 1 Side view of the pressure initiator in the engaged configuration.

[0019] Figure 5 is a top isometric view of the measurement system in the second embodiment.

[0020] Figure 6 yes Figure 5 Exploded isometric view of the measurement system.

[0021] Figure 7 is a top isometric view of a measurement system in a third embodiment.

[0022] Figure 8 A method of manufacturing a measurement system is shown. DETAILED DESCRIPTION

[0023] In the following description, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration embodiments in which the measurement system may be practiced. It should be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the measurement system.

[0024] When features, aspects, or embodiments of a measurement system are described in terms of a process, operation, control flow, or flowchart steps, it will be understood that the steps may be combined, performed in a different order, deleted, or include additional steps without departing from the measurement system as described herein.

[0025] The measurement system is described in sufficient detail to enable one skilled in the art to make and use the measurement system and numerous specific details are provided to provide a thorough understanding of the measurement system; however, it will be apparent that the measurement system may be practiced without these specific details.

[0026] In order to avoid obscuring the measurement system, some well-known system configurations and descriptions are not disclosed in detail. Likewise, the drawings showing embodiments of the system are semi-schematic and not to scale, and in particular, some dimensions are shown exaggerated in the drawings for clarity of presentation. The term "coupled" herein refers to direct or indirect physical contact between elements.

[0027] Reference now Figure 1 , which shows a top isometric view of the measurement system 100 in the first embodiment. The measurement system 100 can be implemented in a wearable device or clothing such as a watch, a ring, a finger clip, a finger cuff, or other wearable items.

[0028] Illustratively, for example, the measurement system 100 may include a pressure-resistant structure, such as a band 102 and a body 104 of a watch. The band 102 and the body 104 may serve as a pressure-resistant structure because the band 102 and the body 104 are not likely to expand outward as pressure increases, but rather constrain the increasing pressure and apply the increasing pressure to a portion of the user that is in direct or indirect contact with the pressure-resistant structure. For example, the pressure-resistant structure may be a watch, a fitness band, a ring, an in-ear watch, an accessory for a mobile phone, or a combination thereof.

[0029] The cuff 102 may include a pressure initiator 108 and is contemplated to provide an inelastic structure for constraining pressure applied to the area where the user contacts the cuff 102 and compressing tissue between the pressure initiator 108 and the body 104. Figure 3 and Figure 4 The pressure initiator 108 is described in greater detail.

[0030] The pressure inducer 108 can provide a controlled pressure ramp, thereby facilitating and enabling very accurate blood pressure readings using wearable electronic devices. The pressure inducer 108 is further shown as being disposed on a side of the cuff 102 opposite the body 104 .

[0031] Thus, the pressure initiator 108 may provide a pressure ramp in the direction of the body 104, wherein the light source, the photodetector and the pressure sensor may be arranged on the body. In alternative embodiments, the light source, the photodetector, the pressure sensor or a combination thereof may be arranged on the pressure-resistant structure or integrally formed with the pressure-resistant structure. Further, it may be alternatively envisaged that the light source, the photodetector, the pressure sensor or a combination thereof is arranged or formed within the pressure initiator 108.

[0032] The loop band 102 may further include a mechanical adjustment mechanism 110 to ensure a universal fit. The mechanical adjustment mechanism 110 may be an adjustable buckle, an adjustable loop band, or even a screw for reducing the interior area of ​​the measurement system 100.

[0033] Reference now Figure 2 , which shows Figure 1 1. As shown, the measurement system 100 includes an annulus 102 having a pressure initiator 108 opposite a body 104 that includes a light source 202, an optical sensor 204, and a pressure sensor 206.

[0034] The light source 202 and the optical sensor 204 can be combined to act as a pulse oximeter for detecting and reading volume fluid changes in the user along a controlled pressure ramp. As shown, both the light source 202 and the optical sensor 204 are arranged in the body 104 and face the same direction.

[0035] Therefore, the light source 202 and the optical sensor 204 generate a reflection signal. That is, the light emitted by the light source 202 is reflected and scattered by the structure in the user's tissue. The reflected light is then received by the optical sensor 204 as volume data, such as photoplethysmography (PPG) data.

[0036] In alternative embodiments, the light source 202 and the optical sensor 204 may be located in different areas of the annulus 102 to generate a transmission signal. With a transmission signal, a portion of the light emitted by the light source 202 passes through the user's tissue and is received by the optical sensor 204.

[0037] The wearable body 104 may further include a processor, such as an application specific integrated circuit for acquiring data from the optical sensor 204. The processor may further provide data acquired from the pressure sensor 206. In an alternative embodiment, the processor may be a remote processor.

[0038] Combining the data from the pressure sensor 206 and the optical sensor 204 can provide volumetric fluid changes at different pressure levels. The different pressure levels can be provided by a controlled ramp of the pressure initiator 108 through a transition temperature range.

[0039] The pressure trigger 108 can be controlled by a microcontroller and can provide a highly controlled pressure input for determining a measurement of volumetric fluid change at various pressure levels. Illustratively, for example, the measurement system 100 can utilize the pressure trigger 108 to trigger pressure on the user's wrist within the cuff 102 .

[0040] The measurement system 100 can detect both the pressure exerted on the user and the volume fluid change using pressure sensor 206 and optical sensor 204, respectively. The volume fluid change and the pressure can be correlated to provide a blood pressure reading of the user.

[0041] It is contemplated that the blood pressure readings may be stored in a non-transitory computer-readable medium within the measurement system 100 and may be transmitted to another system for further processing and analysis. For example, it is contemplated that the blood pressure readings may be periodically shared or updated to the user's medical or exercise record.

[0042] Reference now Figure 3 , which shows Figure 1 1. A side view of the pressure initiator 108 in the released configuration. The pressure initiator 108 may include a base plate 302 for providing fixed support.

[0043] Substrate 302 may support activation layer 304, shape memory layer 306, and passivation layer 308. Activation layer 304 may include a flexible, thermally conductive material having a Figure 1 The heating element is powered by a current source such as a battery contained within the body 104.

[0044] The activation layer 304 can be controlled by a microcontroller to precisely heat the shape memory layer 306 in terms of both the number of heating cycles and the intensity of the heat. The shape memory layer 306 is contemplated to be made of a shape memory material.

[0045] The shape memory material may be a shape memory polymer or a shape memory alloy. The shape memory polymer may be engaged by, for example, raising and lowering the temperature by activating layer 304 .

[0046] Some contemplated shape memory polymers may also be engaged by activation of an electric or magnetic field. In these alternative embodiments, it is further contemplated that the activation layer 304 may be replaced with an electromagnetic or electric field induction layer formed on the top and bottom of the shape memory layer 306. In other contemplated embodiments, the light source 202 may be formed within the flexible layer of the pressure inducer 108.

[0047] For clarity of description, the shape memory layer 306 will be described with respect to shape memory alloys such as copper aluminum nickel alloy, nickel titanium alloy; or zinc, copper, gold and iron alloys. More specifically, the shape memory layer 306 is described with respect to Nitinol (nickel titanium alloy).

[0048] In this illustrative embodiment, shape memory layer 306 is contemplated to have both shape memory and superelastic properties. The shape memory property of shape memory layer 306 may be induced by shaping shape memory layer 306 .

[0049] The shape memory layer 306 may be shaped by constraining the shape memory layer 306 in a shaped state, such as an arc, and then heat treating the shape memory layer 306 while in the shaped state. It is contemplated that heat treating the shape memory layer 306 may include subjecting the shape memory layer 306 to an elevated temperature, such as 400 to 550 degrees Celsius, and then rapidly cooling the shape memory layer 306.

[0050] Illustratively, for example, when the shape memory layer 306 is in a set state, the shape memory layer 306 can maintain the arc shape in the previous example. The set state can be an austenite state. In the austenite state, the volume of the shape memory layer 306 can be greater than the volume of the shape memory layer 306 in the deformable state. Coupling the shape memory layer 306 between the pressure-resistant structure and the user can allow the volume of the shape memory layer 306 to increase to generate or induce pressure on the user's tissue. The activation layer 304 can be flexible and can follow the contour of the shape memory layer in the set state.

[0051] Cooling the shape memory layer 306 below the transition temperature range can force the shape memory layer 306 into a deformable state. The deformable state can be a martensitic state. In the martensitic state, the volume of the shape memory layer 306 can be less than the volume of the shape memory layer 306 in the shaped state. Coupling the shape memory layer 306 between the pressure-resistant structure and the user can allow the volume of the shape memory layer 306 to be reduced to cause less pressure on the user's tissue.

[0052] exist Figure 3 In the released configuration, the pressure initiator 108 is depicted as having the shape memory layer 306 in a deformable state. Figure 4 In the engaged configuration, the pressure initiator 108 is depicted as having the shape memory layer 306 in a set state.

[0053] When the shape memory layer 306 is in a deformable state, the shape memory layer 306 can be deformed into a released configuration, where the shape memory layer can be a flat or straight layer. The activation layer 304 can heat the shape memory layer 306 and restore the shape memory layer 306 to a fixed state by raising the temperature of the shape memory layer 306 above the transition temperature range.

[0054] The shape memory layer 306 can be restored to the deformable state by lowering the temperature of the shape memory layer 306 below the transition temperature range. Illustratively, for example, the activation layer 304 can be turned off, allowing the temperature of the shape memory layer 306 to drop below the transition temperature by dropping back to the user's body temperature.

[0055] The shape memory layer 306 differs from other materials in that when the shape memory layer 306 is in a deformable state, the atomic planes within the shape memory layer 306 can rearrange without causing slippage or permanent deformation. It has been found that in some cases, for some alloys, the maximum deformation that the shape memory material of the shape memory layer 306 can withstand in the deformable state is up to eight percent without causing permanent damage. In comparison, the maximum strain of conventional steel is 0.5 percent.

[0056] The transformation temperature range of the shape memory layer 306 can be composed of four temperatures, which are the martensite start temperature, the martensite finish temperature, the austenite start temperature and the austenite finish temperature. The martensite start temperature refers to the temperature when the shape memory layer 306 starts to change from the austenite state to the martensite state, and the martensite finish temperature refers to the temperature when the shape memory layer 306 completes the transformation from the austenite state to the martensite state.

[0057] The austenite start temperature refers to the temperature at which the shape memory layer 306 begins to change from the martensite state to the austenite state, and the austenite finish temperature refers to the temperature at which the shape memory layer 306 completes the transformation from the martensite state to the austenite state. It is contemplated that the austenite finish temperature of the shape memory layer 306 should be higher than body temperature, which is approximately thirty-seven degrees Celsius, and the martensite finish temperature should be lower than or equal to body temperature.

[0058] Reference now Figure 4 , which shows Figure 1 FIG. 1 is a side view of the pressure initiator 108 in the engaged configuration. As shown, the shape memory layer 306 is in a shaped state and presents an arc-shaped layer. The engaged configuration can increase the pressure applied to the part of the user in contact with the pressure-resistant structure.

[0059] The shape memory layer 306 may be bonded by heating the shape memory layer 306 above the transition temperature range using the activation layer 304. When the shape memory layer 306 enters the set state, the shape memory layer 306 will Figure 3 The flat layer depicted is transformed into Figure 4 The arc layer.

[0060] Shape memory layer 306 may provide a force sufficient to bend activation layer 304 located below shape memory layer 306 and passivation layer 308 located above shape memory layer 306. In other contemplated embodiments, activation layer 304 may change its cross-section rather than bend as a layer.

[0061] That is, activation layer 304 will be thickest where shape memory layer 306 is farthest from substrate 302 and thinnest where shape memory layer 306 is closest to substrate 302. In this further embodiment, activation layer 304 will be in contact with both shape memory layer 306 and substrate 302 when shape memory layer 306 is in the shaped state.

[0062] The passivation layer 308 may be a thermally conductive layer for ensuring that the shape memory layer 306 can be cooled below the transition temperature range to enter the Figure 3 When the shape memory layer 306 is in the shaped state, the passivation layer 308 is forced away from the substrate 302 and the passivation layer is in the deformable state. Figure 1 The ring band 102 can generate pressure within the user's wrist when combined.

[0063] This pressure can be Figure 2 The pressure sensor 206 detects and can be compared with both Figure 2 The light source 202 of the optical sensor 204 is correlated with the pulse oximeter reading. By correlating the pressure reading with the pulse oximeter reading, a blood pressure estimate can be provided.

[0064] More specifically, the volume data may be a PPG signal with a peak amplitude. The volume data may be obtained while obtaining the pressure data of the user. Illustratively, the pressure trigger may increase the pressure applied to the user, which may be detected by the pressure sensor 206 and may change the volume data of the PPG signal detected by the optical sensor 204.

[0065] It is known that the peak amplitude within the PPG signal corresponds to the mean blood pressure measured at the peak amplitude. Systolic and diastolic blood pressure can be calculated as the ratio of the pressure above and below the mean blood pressure.

[0066] Further, by carefully controlling the temperature of the shape memory layer 306 and heating across the transition temperature range, the pressure detected by the pressure sensor 206 can be made to be a controlled ramp. Throughout the transition temperature range, the temperature of the activation layer 304 can be precisely controlled by the microcontroller.

[0067] Reference now Figure 5 , which shows a top isometric view of a measurement system 500 in a second embodiment. The measurement system 500 can be implemented in a wearable device or clothing such as a watch, a ring, a finger clip, a finger sleeve, or other wearable items.

[0068] Illustratively, for example, the measurement system 500 may include a pressure-resistant structure, such as a ring band 502 and a body 504 of a ring. The band 502 and the body 504 may serve as a pressure-resistant structure because the band 502 and the body 504 do not easily expand outward with increasing pressure, but rather constrain the increasing pressure and apply the increasing pressure to the user's part that is in direct or indirect contact with the pressure-resistant structure. For example, the pressure-resistant structure may be an accessory for a watch, a fitness band, a ring, an in-ear watch, a mobile phone, or a combination thereof.

[0069] The cuff 502 may include a pressure initiator 508 and is conceived as a non-elastic structure for constraining the pressure applied to the part of the user in contact with the cuff 502 and compressing the tissue between the pressure initiator 508 and the body 504. Figure 3 and Figure 4 Pressure initiator 508 is described in further detail.

[0070] The pressure inducer 508 can provide a controlled pressure ramp, thereby facilitating and enabling very accurate blood pressure readings using wearable electronic devices. The pressure inducer 508 is further shown as being disposed on a side of the cuff 502 opposite the body 504 .

[0071] Thus, the pressure initiator 508 can provide a pressure ramp in the direction of the body 504, on which the light source, optical sensor, and pressure sensor can be arranged. The light source and optical sensor can be combined to act as a pulse oximeter for detecting and reading volume fluid changes in the user's body along the controlled pressure ramp. The light source and optical sensor can be arranged in the body 504 and face the same direction - towards the pressure initiator 508.

[0072] Therefore, the light source and the optical sensor generate a reflection signal. That is, the light emitted by the light source is reflected and scattered by the structure in the user's tissue. Then, the reflected light is received by the optical sensor.

[0073] In alternative embodiments, the light source and optical sensor may be located in different areas of the annulus 502 to generate a transmission signal. With a transmission signal, a portion of the light emitted by the light source passes through the user's tissue and is received by the optical sensor.

[0074] Reference now Figure 6 , which shows Figure 5 Exploded isometric view of the measurement system 500. As shown, the body 504 and the annulus 502 of the measurement system 500 are divided into two.

[0075] As shown, the cuff 502 has a pressure initiator cavity 602 opposite the body 504. The pressure initiator 508 can be inserted into the pressure initiator cavity 602, thereby rigidly mounting the pressure initiator 508 to the cuff 502.

[0076] Reference now Figure 7 , which shows a top isometric view of a measurement system 700 in a third embodiment. The measurement system 700 can be implemented in a wearable device or clothing such as a watch, a ring, a finger clip, a finger sleeve, or other wearable items.

[0077] Illustratively, for example, the measurement system 700 may include a pressure-resistant structure, such as a ring band 702 and a body 704. The ring band 702 and the body 704 may serve as a pressure-resistant structure because the ring band 702 and the body 704 do not easily expand outward with increasing pressure, but rather constrain the increasing pressure and apply the increasing pressure to the user's part that is in direct or indirect contact with the pressure-resistant structure. For example, the pressure-resistant structure may be an accessory for a watch, a fitness band, a ring, an in-ear watch, a mobile phone, or a combination thereof.

[0078] The cuff 102 may include a pressure initiator 708 and is conceived as a non-elastic structure for constraining the pressure applied to the area where the user contacts the cuff 702 and compressing the tissue between the pressure initiator 708 and the body 704. Figure 3 and Figure 4 Pressure initiator 708 is described in more detail.

[0079] The pressure inducer 708 can provide a controlled pressure ramp, thereby facilitating and enabling very accurate blood pressure readings using wearable electronic devices. The pressure inducer 708 is further shown as being disposed on a side of the cuff 702 opposite the body 704 .

[0080] Thus, the pressure initiator 708 may provide a pressure ramp in the direction of the body 704 , on which the light source 710 , the optical sensor 712 and the pressure sensor 714 may be arranged.

[0081] The light source 710 and the optical sensor 712 can be combined to act as a pulse oximeter for detecting and reading volume fluid changes in the user's body along a controlled pressure ramp. As shown, both the light source 710 and the optical sensor 712 are arranged in the body 704 and face the same direction - toward the pressure trigger 708.

[0082] Therefore, the light source 710 and the optical sensor 712 generate a reflection signal. That is, the light emitted by the light source 710 is reflected and scattered by the structure in the user's tissue. Then, the reflected light is received by the optical sensor 712.

[0083] In alternative embodiments, the light source 710 and the optical sensor 712 may be located in different areas of the annulus 702 to generate a transmission signal. With a transmission signal, a portion of the light emitted by the light source 710 passes through the user's tissue and is received by the optical sensor 712.

[0084] The body 704 of the wearable device may further include a processor 716, such as an application specific integrated circuit for acquiring data from the optical sensor 712. The processor 716 may further provide data acquired from the pressure sensor 714.

[0085] Combining the data from the pressure sensor 714 and the optical sensor 712 can provide volumetric fluid changes at different pressure levels. The different pressure levels can be provided by a controlled ramp of the pressure initiator 708 through a transition temperature range.

[0086] Pressure initiator 708 may be controlled by microcontroller 718, which may provide a highly controlled current from current source 720. Current source 720 may be a battery, capacitor, or a device for heating. Figure 3The activation layer 304 is another current source.

[0087] Microcontroller 718 and current source can together provide a controlled pressure ramp for determining a measurement of volumetric fluid change at various pressure levels. Illustratively, for example, measurement system 700 can utilize pressure inducer 708 to induce pressure on a user's finger within cuff 702 .

[0088] The pressure ramp applied by the pressure initiator can exhibit a known superelastic or shape memory displacement as a function of temperature. That is, because a specific temperature is known to equate to a specific shape and state of the shape memory material, both the physical shape of the shape memory layer and the heat applied to the shape memory layer can be used to carefully control the pressure ramp of the pressure initiator.

[0089] The measurement system 700 can detect both the pressure exerted on the user and the volumetric fluid change using pressure sensor 714 and optical sensor 712, respectively. The volumetric fluid change and the pressure can be correlated to provide a blood pressure reading of the user.

[0090] Illustratively, for example, the volume data may be a PPG signal whose peak amplitude corresponds in time to the mean blood pressure. That is, the pressure reading at the peak amplitude of the volume data will be associated with the mean blood pressure detected at the same time the peak amplitude was measured. The systolic and diastolic pressures may be calculated as a ratio above and below the mean blood pressure.

[0091] It has been unexpectedly discovered that this method of correlating pressure readings to peak amplitude using a shape memory controlled pressure ramp due to a controllable superelastic or shape memory force displacement over a known temperature range allows for calibration-free, cuff-free blood pressure measurement. Previous attempts required frequent recalibration due to greater variability in other previously used force inducing mechanisms.

[0092] The annulus 702 may further include a pressure plate 722 attached to the pressure initiator 708. Figure 3 The passivation layer 308 in the pressure plate 722 can provide a large surface area through which the pressure from the pressure trigger 708 can be distributed on the user's finger.

[0093] The pressure plate 722 may also provide a heat sink, thereby allowing the Figure 3 The heat of the shape memory layer 306 is diffused out of the shape memory layer 306 and into the pressure plate 722, thereby allowing the shape memory layer 306 to cool more quickly and thereby enter the deformable state more quickly.

[0094] It can be further seen that the annulus 702 includes a notch 724. The notch can be relatively fixed within the rigid annulus 702, but can allow for slight movement or provide an upper pressure limit, wherein once an upper pressure threshold is reached, the notch 724 will increase in size.

[0095] It is contemplated that blood pressure readings may be stored in a non-transitory computer-readable medium within the measurement system 700 and may be transmitted to another system for further processing and analysis. For example, it is contemplated that blood pressure readings may be periodically shared or updated to a user's medical or exercise record.

[0096] Reference now Figure 8 , wherein a method of manufacturing a measurement system is shown. The manufacturing method may include: in box 802, providing a pressure-resistant structure; in box 804, coupling the pressure trigger to the pressure-resistant structure, the pressure trigger having an activation layer and a shape memory layer, the shape memory layer being configured to have a shaped state and a deformable state, the activation layer being configured to trigger the shape memory layer to enter the shaped state and to increase the pressure applied to a portion of the user in contact with the pressure-resistant structure; in box 806, coupling a light source to the pressure-resistant structure; in box 808, coupling an optical sensor to the pressure-resistant structure and being configured to detect a signal from the light source; in box 810, coupling the pressure sensor to the pressure-resistant structure, the pressure sensor being configured to detect the pressure applied to the portion of the user in contact with the pressure trigger; and in box 812, coupling the processor to the optical sensor and the pressure sensor, the processor being configured to correlate volume data from the optical sensor with pressure data from the pressure sensor and provide a blood pressure measurement.

[0097] Thus, it has been discovered that the measurement system provides important and heretofore unknown and unavailable solutions, capabilities and functional aspects. The resulting configuration is simple, economical, uncomplicated, highly versatile, accurate, sensitive and effective, and can be implemented by employing known components for ready, efficient and economical manufacture, application and utilization.

[0098] Although the measurement system has been described in conjunction with a particular best embodiment, it should be understood that many alternatives, modifications and variations will be apparent to those skilled in the art in light of the foregoing description. Therefore, it is intended that all such alternatives, modifications and variations falling within the scope of the appended claims be encompassed herein. All subject matter set forth herein or shown in the accompanying drawings is to be interpreted in an illustrative and non-limiting sense.

Claims

1. A measurement system comprising: Pressure-resistant structure; a pressure initiator coupled to the pressure-resistant structure, the pressure initiator having an activation layer laminated with the shape memory layer, the activation layer conforming to the shape of the shape memory layer in a shaped state, and having an engagement configuration that increases pressure applied to a portion of the user in contact with the pressure-resistant structure; a light source coupled to the pressure-resistant structure; an optical sensor coupled to the pressure-resistant structure and configured to detect a signal from the light source; a pressure sensor coupled to the pressure-resistant structure, the pressure sensor being configured to detect pressure applied to a portion of the user in contact with the pressure initiator; as well as A processor is coupled to the optical sensor and the pressure sensor, the processor being configured to correlate volume data from the optical sensor with pressure data from the pressure sensor and provide a blood pressure measurement.

2. The system of claim 1, wherein: The pressure inducer further includes a substrate and a passivation layer.

3. The system of claim 1, wherein: The processor is an application specific integrated circuit for acquiring the volume data from the optical sensor and acquiring the pressure data from the pressure sensor.

4. The system of claim 1, further comprising a pressure plate coupled to the pressure initiator, the pressure plate configured to distribute the pressure applied from the pressure initiator to the user.

5. The system of claim 1, further comprising a mechanical adjustment mechanism coupled to the pressure-resistant structure, the mechanical adjustment mechanism for providing a universal fit.

6. A measurement system comprising: A pressure-resistant structure, comprising an annular belt and a body; a pressure initiator coupled to the annular band, the pressure initiator having an activation layer and a shape memory layer, the shape memory layer being configured to have a shaped state and a deformable state, the activation layer being laminated with the shape memory layer, the activation layer being conformal to the shape of the shape memory layer in the shaped state, and the activation layer being configured to induce the shape memory layer to enter the shaped state and to increase the pressure applied to the site of contact between the user and the pressure-resistant structure; a light source coupled to the body; an optical sensor coupled to the body and configured to detect a signal from the light source; a pressure sensor coupled to the pressure-resistant structure, the pressure sensor being configured to detect pressure applied to a portion of the user in contact with the pressure initiator; as well as A processor is coupled to the optical sensor and the pressure sensor, the processor being configured to correlate volume data from the optical sensor with pressure data from the pressure sensor and provide a blood pressure measurement.

7. The system of claim 6, wherein: The shape memory layer is a shape memory polymer or a shape memory alloy.

8. The system of claim 6, wherein: The activation layer is configured to induce the shape memory layer to enter the shaped state by adding heat.

9. The system of claim 6, further comprising a microcontroller coupled to the pressure inducer, the microcontroller configured to control a current source to heat the activation layer and provide a controlled pressure ramp.

10. A method of manufacturing a measurement system, comprising: Provide pressure-resistant structure; coupling a pressure initiator to the pressure-resistant structure, the pressure initiator having an activation layer laminated with the shape memory layer, the activation layer conforming to the shape of the shape memory layer in a shaped state, and the pressure initiator having an engagement configuration that increases pressure applied to a portion of the user in contact with the pressure-resistant structure; coupling a light source to the pressure-resistant structure; coupling an optical sensor to the pressure-resistant structure and configured to detect a signal from the light source; coupling a pressure sensor to the pressure-resistant structure, the pressure sensor being configured to detect pressure applied to a portion of the user in contact with the pressure initiator; as well as The processor is coupled to the optical sensor and the pressure sensor, the processor being configured to correlate volume data from the optical sensor with pressure data from the pressure sensor and provide a blood pressure measurement.

11. The method of claim 10, wherein: Coupling the pressure initiator further includes coupling a pressure initiator having a substrate and a passivation layer.

12. The method of claim 10, wherein: Coupling the processor includes coupling an application specific integrated circuit for acquiring the volume data from the optical sensor and acquiring the pressure data from the pressure sensor.

13. The method of claim 10, further comprising coupling a pressure plate to the pressure initiator, the pressure plate configured to thermally conduct heat away from the pressure initiator.

14. The method of claim 10, further comprising coupling a mechanical adjustment mechanism to the pressure-resistant structure, the mechanical adjustment mechanism for providing a universal fit.

15. The method of claim 10, wherein: Providing the pressure-resistant structure includes providing an annulus and a body; coupling the pressure initiator comprises coupling the pressure initiator to the cuff, the pressure initiator having the activation layer and the shape memory layer, the shape memory layer being configured to have the shaped state and the deformable state, the activation layer being configured to induce the shape memory layer to enter the shaped state to provide the engaged configuration, and to increase the pressure applied to the site of the user in contact with the pressure-resistant structure; Coupling the light source includes coupling the light source to the body; and Coupling the optical sensor includes coupling the optical sensor to the body.

16. The method of claim 15, wherein: Coupling the pressure initiator includes coupling the pressure initiator with the shape memory layer, the shape memory layer being formed of a shape memory polymer or a shape memory alloy.

17. The method of claim 15, wherein: Coupling the pressure initiator includes coupling the pressure initiator with the activation layer, the activation layer configured to distribute pressure applied from the pressure initiator to the user.

18. The method of claim 15, further comprising coupling a microcontroller to the pressure inducer, the microcontroller configured to control a current source to heat the activation layer and provide a controlled pressure ramp.

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