Non-invasive blood pressure sensor

Abstract

The present invention is entitled "Non-invasive blood pressure sensor." Exemplary systems, devices, and methods for sensing a force applied by an external source in a fluid monitoring tube are disclosed. An exemplary system includes a force sensing device and a signal conditioning circuit configured to be electrically coupled to the force sensing device. The exemplary system also includes a housing configured to enclose the force sensing device and the signal conditioning circuit. The housing includes a snap structure configured to attach the housing to a floor and to hold the force sensing device and the signal conditioning circuit in the housing.

Description

Technical Field

[0001] The exemplary embodiments of this disclosure relate generally to sensors, and more specifically to force sensors. Background Technology

[0002] Industrial and commercial applications, including medical devices, are increasingly utilizing force sensors to determine the applied force. However, conventional force sensor designs cannot be easily and cost-effectively integrated into disposable blood pressure monitoring devices.

[0003] The applicant has identified numerous shortcomings and problems associated with conventional force sensors. Through effort, ingenuity, and innovation, many of these identified problems have been addressed by the developed solutions, including those described in the embodiments of this disclosure, and numerous examples of these solutions are detailed herein. Summary of the Invention

[0004] This document discloses systems, apparatus, and methods (including, but not limited to, manufacturing and packaging methods) for providing a disposable blood pressure monitoring device with a miniature force sensor package design, wherein the force sensor package design employs a gel-based coupling technology. In some embodiments, the miniature force sensor package design provided herein addresses the aforementioned issues by providing a coupling interface that enables the miniature force sensor to be easily and cost-effectively integrated into a variety of application areas and equipment, including disposable blood pressure monitoring devices.

[0005] In one exemplary embodiment, a system is provided for sensing a force applied by an external source in a fluid monitoring tube. The system includes a force sensing device and signal conditioning circuitry configured to be electrically coupled to the force sensing device. The system also includes a housing configured to enclose the force sensing device and the signal conditioning circuitry. The housing includes a snap-fit ​​structure configured to attach the housing to a base plate and retain the force sensing device and the signal conditioning circuitry within the housing.

[0006] In another exemplary embodiment, a device is provided for sensing a force applied by an external source in a fluid monitoring tube. The device includes a force sensing device and a signal conditioning circuit configured to be electrically coupled to the force sensing device. The device also includes a housing configured to enclose the force sensing device and the signal conditioning circuit. The housing includes a snap-fit ​​structure configured to attach the housing to a base plate and retain the force sensing device and the signal conditioning circuit within the housing. Furthermore, the housing defines an aperture configured to provide a coupling interface, which provides a path for force to be transferred to the force sensing device via a coupling element. The device also includes the base plate.

[0007] In yet another exemplary embodiment, a method is provided for manufacturing an apparatus for sensing a force applied by an external source in a fluid monitoring tube. The method includes mounting a force sensing device on a surface of a substrate. The method also includes mounting signal conditioning circuitry on the surface of the substrate. The method further includes assembling a housing that encloses at least the force sensing device and the signal conditioning circuitry. The housing includes a snap-fit ​​structure configured to retain the force sensing device and the signal conditioning circuitry within the housing. The method also includes attaching the housing to a base plate using the snap-fit ​​structure.

[0008] The foregoing description of the invention is provided merely to outline some exemplary embodiments and to provide a basic understanding of some aspects of this disclosure. Therefore, it should be understood that the above embodiments are merely illustrative and should not be construed as limiting the scope or substance of this disclosure in any way. It should be understood that, in addition to those summarized herein, the scope of this disclosure covers many other possible embodiments, some of which will be further described below. Attached Figure Description

[0009] Some exemplary embodiments of this disclosure have been described in general terms above. Reference will now be made to the accompanying drawings, which are not necessarily drawn to scale.

[0010] Figure 1A , Figure 1B , Figure 1C and Figure 1D An exemplary top view, an exemplary isometric view, an exemplary sectional view, and another exemplary sectional view of an exemplary disposable blood pressure monitoring device according to some exemplary embodiments described herein are shown respectively.

[0011] Figure 2A An exemplary cross-sectional view of another exemplary disposable blood pressure monitoring device according to some exemplary embodiments described herein is shown.

[0012] Figure 2B An exemplary isometric view of an exemplary force sensing component according to some exemplary embodiments described herein is shown.

[0013] Figure 3 A functional block diagram of an exemplary disposable blood pressure monitoring device according to some exemplary embodiments described herein is shown.

[0014] Figure 4 A flowchart is shown illustrating exemplary operation for providing an exemplary disposable blood pressure monitoring device according to some exemplary embodiments described herein. Detailed Implementation

[0015] The following description should be read with reference to the accompanying drawings, in which similar reference numerals denote similar elements throughout the views. The detailed description and drawings illustrate several embodiments intended to illustrate the disclosure. It should be understood that any designations of the disclosed features (e.g., first, second, etc.) and / or directional terms used with the disclosed features (e.g., front, back, lower, upper, etc.) are relative terms indicating illustrative relationships between related features.

[0016] First, it should be understood that although exemplary embodiments of one or more aspects are shown below, the disclosed components, systems, and methods can be implemented using any number of techniques (whether currently known or not yet available). This disclosure should in no way be limited to the exemplary embodiments, drawings, and techniques shown below, but modifications can be made within the scope of the appended claims and their equivalents. Although dimensional values ​​for various elements are disclosed, the drawings may not be drawn to scale.

[0017] The word "example" is used herein to mean "served as an example, instance, or illustration." Any implementation described herein as an "example" is not necessarily more preferred or advantageous than other implementations.

[0018] Force sensors are generally used in a variety of applications, including but not limited to infusion pumps, mobile non-invasive pumps, occlusion detection, enteral pumps, load and compression sensing, variable tension control, and other application areas. Furthermore, there is a growing market demand for smaller force sensors. In some applications, users may require a force sensor that is small enough to fit within the application area while still providing a sufficiently large deployment interface. For example, the disposable blood pressure monitoring market is a large one, with over 20 million devices installed annually. In many cases, these disposable blood pressure monitoring devices must meet the specifications and performance requirements of the BP22 standard for blood pressure transducers issued by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Devices (AAMD). However, the disposable blood pressure monitoring market is facing increasing pressure to provide low-cost solutions for sterile disposable blood pressure monitoring devices.

[0019] Existing disposable blood pressure monitoring devices typically consist of a laser-trimmed pressure sensor encapsulated in a standard housing assembly. This standard housing assembly features a Luer lock that engages with the tubing and is transparent to allow visualization of blood flow. It also houses the sensor and provides a cable output. However, these disposable blood pressure monitoring devices are too expensive to meet the market's growing demand for low-cost solutions that utilize sterilized, disposable blood pressure monitoring devices.

[0020] This disclosure addresses these problems by describing a unique design for a disposable blood pressure monitoring device that replaces the conventional laser-trimmed ceramic plate design (a cost driver for such devices) with a small force-sensing die. This small force-sensing die incorporates a deep reactive ion etching (DRIE) process to minimize the size of the force-sensing component, thereby minimizing the overall size of the blood pressure monitoring device. This disclosure also addresses these problems by describing a specialized solution that adjusts the bridge output of the force-sensing device to correct for offset and span temperature effects. This disclosure further addresses these problems by describing a design that seals the force-sensing device into the housing by assembling a radial sealing ring structure within the housing to engage the outer diameter of a gel ring on the force-sensing device, thus assembling the force-sensing device into the housing without gluing. This disclosure also describes using one or more snap-fit ​​structures disposed between the base plate and the housing to hold the force-sensing components (e.g., the force-sensing device, gel ring, gel, signal conditioning circuitry, substrate, and wire bonding) within the housing, and mounting cable clips to wedge-shaped terminals on the back of the substrate (e.g., a printed circuit board (PCB)) using surface mount technology (SMT). These wedge-shaped terminals can act as springs to engage cables and form electrical connections with external devices.

[0021] In some embodiments, this disclosure describes a multi-level assembly. The first-level assembly may involve a force-sensing component (e.g., a force-sensing device, gel ring, gel, signal conditioning circuitry, substrate, and wire bonding), which can be manufactured using a PCB panel having four wedge-shaped terminals mounted to various locations on the panel using SMT. The PCB panel can be a very high-density panel to reduce unit cost (e.g., a panel providing more than 500 positions, and potentially up to 1,500 positions on a single panel). The force-sensing device may include a pressure range gauge sensing die adhered to the PCB substrate and wire-bonded to the PCB. In some embodiments, the pressure range gauge sensing die may be a one-bar pressure range gauge sensing die. A digitally controlled resistor network may be adhered to and wire-bonded to the PCB. A gel ring (e.g., a metal ring) may be adhered to the PCB around the sensing die and wire bonding and filled with a biocompatible room temperature vulcanizing (RTV) material, such as silicone. The force-sensing component can then be packaged in a reel package for delivery to a final assembly line.

[0022] Final assembly may involve picking up the force sensing component from the reel packaging and placing it into the housing by pressing the gel ring into a mating hole in the fluid monitoring tube of the housing. This pressure fit seals the force sensing component into the housing. In some embodiments, the seal may be propagated by another compliant element specifically designed to seal between the orifice and the sensor gel ring. The back side of the force sensing component PCB may include four wedge-shaped terminals that are exposed to allow the force sensing component to receive a cable bundle (e.g., a wire harness) with a stripped cable that can mate into a groove on the housing. The groove on the housing can facilitate alignment of the cable with terminals on the PCB. A base plate engages the housing and presses the cable against the terminals on the PCB. The base plate may also provide support and, in some cases, push the PCB to hold the gel ring within the housing. The blood pressure monitoring device may be held together by one or more snap-fit ​​structures in the plastic base plate engaging the mating structure in the housing, and vice versa. The one or more snap-fit ​​structures can be tight enough to hold the components together and keep the electrical contacts engaged throughout the product's lifespan, in some cases for two years of shelf storage and three days of operational use.

[0023] Figure 1A , Figure 1B , Figure 1C and Figure 1D Exemplary top view, exemplary isometric view, exemplary sectional view, and another exemplary sectional view AA are shown, respectively, of an exemplary disposable blood pressure monitoring device 100 according to some exemplary embodiments described herein. The exemplary disposable blood pressure monitoring device 100 may include any combination of components, structures, and features described herein, including the addition, omission, or rearrangement of components, structures, and features. In some embodiments, the exemplary disposable blood pressure monitoring device 100 may be a hardware device having embedded software configured to measure, detect, and transmit data (e.g., temperature, pressure, motion, and other suitable data). In some embodiments, the embedded software may be configured to run within a device, apparatus, or unit (e.g., firmware).

[0024] In some implementation schemes, such as Figure 1A , Figure 1B , Figure 1C and Figure 1DAs shown, an exemplary disposable blood pressure monitoring device 100 may include (e.g., using one or more snap-fit ​​structures) a base plate 102 (e.g., a plastic base plate) attached to a housing 104, which includes a fluid monitoring tube, a Luer lock 106, and a Luer lock fitting 108. For example, the housing 104 may include snap-fit ​​structures configured to attach the housing 104 to the base plate 102 and retain a force sensing device 110 and optional signal conditioning circuitry within the housing 104. In some embodiments, the one or more snap-fit ​​structures may be disposed between the base plate 102 and the housing 104 to retain the force sensing components within the housing 104 and clamp one or more cables 114 onto one or more wedge terminals that can be SMT-mounted to a second surface 112b (e.g., the back side) of a substrate 112. The one or more wedge terminals may act as springs to engage one or more cables 114 and form an electrical connection to an external device.

[0025] In some embodiments, the housing 104 may be optically transparent or nearly transparent to allow visual confirmation (e.g., through an imaging device or the user's eye) that there are no air bubbles in the fluid in the fluid monitoring tube or that air bubbles have been removed therefrom. In some embodiments, the base plate 102 may not be optically transparent or nearly transparent. For example, the housing 104, the base plate 102, or both may be made of an optically transparent polymer or plastic.

[0026] In some embodiments, the exemplary disposable blood pressure monitoring device 100 may further include a force sensing component comprising a force sensing device 110 (e.g., including a force sensing die, a gel ring, and a biocompatible RTV material, such as silicone gel), optional signal conditioning circuitry, wire bonding, and a substrate 112 (e.g., a PCB). The substrate 112 may include a first surface 112a (e.g., a top surface) and a second surface 112b (e.g., a bottom surface) opposite the first surface 112a. The force sensing device 110 may be configured to be disposed on the first surface 112a of the substrate. In some embodiments, the force sensing device 110 may be an analog force sensing device. In some embodiments, the force sensing device 110 may be a digital force sensing device. In some embodiments, the force sensing device 110 may include at least one of a piezoresistive force sensing device and a microelectromechanical system (MEMS) force sensing device. In some embodiments, the force sensing die included in the force sensing device 110 may be a miniature force sensing die that incorporates DRIE processing to minimize the overall size of the force sensing component, thereby minimizing the overall size of the exemplary disposable blood pressure monitoring device 100.

[0027] In some embodiments, housing 104 may be configured to encapsulate force sensing device 110. For example, housing 104 may define an aperture 113 configured to provide a coupling interface for force to be transferred to force sensing device 110 via a coupling element. In some embodiments, the center of aperture 113 may be configured to align with the center of force sensing device 110. In some embodiments, the coupling element may be a gel-based coupling element comprising a gel configured to transmit force to the force sensing device. For example, the gel may be a biocompatible RTV material, such as silicone. In some embodiments, force sensing device 110 may be sealed to housing 104 without adhesive bonding by, for example, assembling a radial sealing ring structure in housing 104 to engage the outer diameter of a gel ring on force sensing device 110.

[0028] In some embodiments, a plurality of electrical contact pads (e.g., four electrical contact pads) may be provided on the second surface 112b of the substrate. In some embodiments, the exemplary disposable blood pressure monitoring device 100 may also include cables 114 (e.g., four cables), cable bundles 116, and electrical connection terminals 118 (e.g., a six-pin plug). For example, the plurality of electrical contact pads may be a plurality of wedge terminals or may be attached to a plurality of wedge terminals (e.g., four wedge terminals) configured to mechanically couple a plurality of cables 114 to the plurality of electrical contact pads.

[0029] In some implementation schemes, such as Figure 1C As shown, an exemplary disposable blood pressure monitoring device 100 may include a cable catcher comprising one or more cable catcher support structures configured to hold cables 114 against a substrate 112. For example, the substrate 102 may include a cable catcher support structure 134 configured to engage one or more cables 114. In some cases, the cable catcher support structure 134 on the substrate 102 may clamp one or more cables 114 against one or more electrical contact pads disposed on or attached to a second surface 112b of the substrate 112. In some cases, the cable catcher support structure 134 on the substrate 102 may define a semi-circular notch for each of the one or more cables 114. For example, the semi-circular notch may have a diameter substantially similar to the diameter of each of the one or more cables 114. Thus, as Figure 1CAs shown, the lower half of each of one or more cables 114 may be positioned within each of one or more semi-circular recesses of the cable catcher support structure 134, and only the upper half of each of one or more cables 114 may protrude above the cable catcher support structure 134. In some embodiments, the housing 104 may include a cable catcher support structure 133 configured to restrict upward movement of one or more cables 114 and restrict lateral movement of the substrate 112.

[0030] In some embodiments, the base plate 102 may be attached to the housing 104 using adhesives, one or more snap-fit ​​structures, any other suitable attachment mechanism (e.g., screws, fasteners), or a combination thereof. For example, the housing 104 may include a downward protrusion 125 configured to attach to an upward protrusion 131 on the base plate 102. In some cases, such as Figure 1A , Figure 1B , Figure 1C and Figure 1D As shown, the outward surface of the downward protrusion 125 of the housing 104 can be configured to attach to the inward surface of the upward protrusion 131 of the base plate 102. In other cases, the inward surface of the downward protrusion 125 of the housing 104 can be configured to attach to the outward surface of the upward protrusion 131 of the base plate 102.

[0031] In some embodiments, the downward protrusion 125 of the housing 104 may be configured to be attached to the upward protrusion 131 of the base plate 102 using an adhesive (such as a two-part epoxy resin). In some embodiments, the downward protrusion 125 of the housing 104 may be configured to be attached to the upward protrusion 131 of the base plate 102 using one or more snap-fit ​​structures. In some embodiments, the bottom of the outer surface of the downward protrusion 125 of the housing 104 may have an outward protrusion, and the bottom of the inner surface of the upward protrusion 131 of the base plate 102 may have a notch or groove configured to receive the outward protrusion of the downward protrusion 125 of the housing 104. When the outward surface of the downward protrusion 125 of the outer casing 104 is inserted against the inward surface of the upward protrusion 131 of the base plate 102, the downward protrusion 125 can be biased inward by the outward protrusion of the downward protrusion 125 that is in contact with the inward surface of the upward protrusion 131 of the base plate 102. Once the outward protrusion of the downward protrusion 125 is inserted into the notch or groove of the inward surface of the upward protrusion 131, the downward protrusion 125 can be snapped outward to its initial unbiased position, thereby locking the outer casing 104 into the base plate 102.

[0032] In some embodiments, optional signal conditioning circuitry may be configured to be electrically coupled to the force sensing device 110 and a plurality of electrical contact pads, and housing 104 may also be configured to encapsulate the optional signal conditioning circuitry. In some embodiments, such as Figure 1A , Figure 1B , Figure 1C and Figure 1D As shown, when the force sensing device 110 is a digital force sensing device, the bottom surface of an optional signal conditioning circuit can be configured to be disposed on the first surface 112a of the substrate 112, and the force sensing device 110 can be configured to be disposed on the top surface of the optional signal conditioning circuit (e.g., the optional signal conditioning circuit can be disposed between the force sensing device 110 and the substrate 112). In some embodiments, when the force sensing device 110 is an analog force sensing device or a digital force sensing device, the optional signal conditioning circuit can be configured to be disposed separately from the force sensing device 110 on the first surface 112a of the substrate (e.g., as shown in the diagram). Figure 2B (As arranged in the diagram). In some embodiments, optional signal conditioning circuitry may be configured to adjust the bridge output of the force sensing device 110 to correct for offset and span temperature effects.

[0033] In some embodiments, the exemplary disposable blood pressure monitoring device 100 may include a digitally controlled resistor network 120. For example, the digitally controlled resistor network 120 may include electrically erasable programmable read-only memory (EEPROM) circuitry configured to meet specific requirements of the force sensing component, the exemplary disposable blood pressure monitoring device 100, or both. In some embodiments, the digitally controlled resistor network 120 may be an encrypted memory storage device to prevent counterfeit sensors from working with the exemplary disposable blood pressure monitoring device 100. In some embodiments, the digitally controlled resistor network 120 may be a digital encryption device. In some embodiments, the digitally controlled resistor network 120 may be an analog encryption device. In some embodiments, such as... Figure 1B , Figure 1C and Figure 1D As shown, the digitally controlled resistor network 120 may be disposed on the second surface 112b of the substrate 112 (e.g., the back side or the terminal side).

[0034] Figure 2A An exemplary cross-sectional view of an exemplary disposable blood pressure monitoring device 200 according to some exemplary embodiments described herein is shown. In some embodiments, such as Figure 2AAs shown, an exemplary disposable blood pressure monitoring device 200 may include a base plate 202 (e.g., a plastic base plate) attached to a housing 204, which includes a fluid monitoring tube, a Luer lock 206, and a Luer lock fitting 208. In some embodiments, the housing 204 may include one or more snap-fit ​​structures (e.g., snap-fit ​​structure 225, snap-fit ​​structure 227, or both) configured to attach the housing 204 to the base plate 202 and retain the force sensing device 210 and optional signal conditioning circuitry 220 within the housing 204.

[0035] In some embodiments, one or more snap-fit ​​structures (such as snap-fit ​​structures 225 and 227) may be used to attach the base plate 202 to the housing 204. In some embodiments, the force sensing component may be held within the housing 204 by snap-fit ​​structures 225 and 227. In some embodiments, snap-fit ​​structures 225 and 227 may be disposed between the base plate 202 and the housing 204 to hold the force sensing component within the housing 204 and to clamp one or more cables 214 onto one or more wedge terminals 224, which may be SMT mounted to a second surface 212b (e.g., the back side) of the substrate 212. The one or more wedge terminals 224 may act as springs to engage one or more cables 214 and form an electrical connection to an external device.

[0036] In some embodiments, the snap-fit ​​structure 225 may be a flexible arm (e.g., a cantilever) connected to the housing 204 at its top end and having an inwardly projecting portion 229 at its bottom end. The base plate 202 may have an opening 231 configured to receive the snap-fit ​​structure 225. When the snap-fit ​​structure 225 is inserted into the opening 231 in the base plate 202, the snap-fit ​​structure 225 may be outwardly biased by the inwardly projecting portion 229 contacting the inward side of the opening 231. Once the inwardly projecting portion 229 of the snap-fit ​​structure 225 is inserted into the opening 231 in the base plate 202, the snap-fit ​​structure 225 snaps inward to its initial unbiased position, thereby locking the housing 204 into the base plate 202.

[0037] In some embodiments, the snap-fit ​​structure 227 may be a flexible arm (e.g., a cantilever) connected to the housing 204 at its top end and having an inwardly projecting portion 230 at its bottom end. The base plate 202 may have an opening 232 configured to receive the snap-fit ​​structure 227. When the snap-fit ​​structure 227 is inserted into the opening 232 in the base plate 202, the snap-fit ​​structure 227 may be outwardly biased by the inwardly projecting portion 230 contacting the inward side of the opening 232. Once the inwardly projecting portion 230 of the snap-fit ​​structure 227 is inserted into the opening 232 in the base plate 202, the snap-fit ​​structure 227 snaps inward to its initial unbiased position, thereby locking the housing 204 into the base plate 202.

[0038] In some embodiments, the housing 204 may be optically transparent or nearly transparent to allow visual confirmation (e.g., through an imaging device or the user's eye) that air bubbles are absent or have been removed from the fluid in the fluid monitoring tube. In some embodiments, the base plate 202 may not be optically transparent or nearly transparent. For example, the housing 204 may be made of an optically transparent polymer or plastic, while the base plate 202 may be made of a non-optically transparent polymer or plastic.

[0039] In some embodiments, the exemplary disposable blood pressure monitoring device 200 may further include a force sensing assembly comprising a force sensing device 210 (e.g., including a force sensing die, a gel ring 211, and a gel 217 having a gel surface 215 (e.g., a biocompatible RTV material, such as silicone gel)), a wire bonding portion 221, optional signal conditioning circuitry 220, a wire bonding portion 223, and a substrate 212 (e.g., a PCB). The substrate 212 may include a first surface 212a (e.g., a top surface) and a second surface 212b (e.g., a bottom surface) opposite the first surface 212a.

[0040] In some embodiments, gel 217 forms a gel surface 215 at the sharp top surface of gel ring 211, allowing forces from an external source to be directly concentrated onto force sensing device 210 via gel 217. In some embodiments, gel surface 215 may be dome-shaped or convex to prevent air bubbles from getting stuck in the fluid monitoring tube during fluid flow. For example, in some embodiments, a concave gel surface may form a low-velocity zone in the fluid flow path, and this low-velocity zone may act as a bubble trap. In some embodiments, the dome-shaped or convex gel surface may protrude slightly into the fluid flow path for use in higher-velocity zones within the fluid flow path, thereby reducing the incidence of bubble trapping without forming bubble traps at the edges.

[0041] In some embodiments, gel 217 may be injected into gel ring 211. When gel 217 reaches the sharp top surface of gel ring 211, gel 217 stops and forms beads, resulting in the formation of a gel surface 215 (e.g., a dome-shaped or convex gel surface) of gel 217 at the periphery of hole 213. For example, surface tension effects, adhesion effects, or both may explain the formation of the gel surface 215 (e.g., a dome-shaped or convex gel surface) of gel 217 at the periphery of the sharp top surface of gel ring 211. In some embodiments, gel 217 may be a liquid gel. In other embodiments, gel 217 may be a semi-liquid gel. In one exemplary embodiment, gel 217 may be a dielectric gel. In another exemplary embodiment, gel 217 may be a non-dielectric gel. In some embodiments, gel 217 may be a silicone-based gel. It should be understood that gel 217 is merely one example of an actuator, and it is conceivable that other suitable actuators may be used.

[0042] In some embodiments, optional signal conditioning circuitry 220 may be configured to be electrically coupled to force sensing device 210 via one or more wire bonds. For example, optional signal conditioning circuitry 220 may be configured to be electrically coupled to substrate 212 via one or more wire bonds 223, force sensing device 210 may be configured to be electrically coupled to substrate 212 via one or more wire bonds 221, and optional signal conditioning circuitry 220 may be configured to be electrically coupled to force sensing device 210 via substrate 212. In other embodiments, the electrical connection may be solder bumps or other electrical bonding techniques, such as through-silicon vias with solder bumps or thermo-ultrasonic ball bumps that provide improved space. In some embodiments, optional signal conditioning circuitry 220 may be configured to adjust the bridge output of force sensing device 210 to correct for offset and span temperature effects.

[0043] In some embodiments, the force sensing device 210 may be configured to be disposed on a first surface 212a of a substrate. In some embodiments, the force sensing device 210 may be an analog force sensing device. In some embodiments, the force sensing device 210 may be a digital force sensing device. In some embodiments, the force sensing device 210 may include at least one of a piezoresistive force sensing device and a MEMS force sensing device. In some embodiments, the force sensing die included in the force sensing device 210 may be a miniaturized force sensing die that incorporates DRIE processing to minimize the overall size of the force sensing component, thereby minimizing the overall size of the exemplary disposable blood pressure monitoring device 200.

[0044] In some embodiments, housing 204 may be configured to encapsulate force sensing device 210. For example, housing 204 may define an aperture 213 configured to provide a coupling interface for transferring forces (e.g., forces applied by an external source (e.g., blood) in a fluid monitoring tube of housing 204) to force sensing device 210 via a coupling element (e.g., gel 217 disposed in gel ring 211 and having gel surface 215). In some embodiments, aperture 213 defined in housing 204 may have a cross-section such as circular, elliptical, oval, or polygonal. In some embodiments, aperture 213 may have a cross-sectional radius such as, but not limited to, 1.44 mm, 1.54 mm, 1.64 mm, or any other suitable radius. In some embodiments, the center of aperture 213 may be configured to align with the center of force sensing device 210. In some embodiments, the coupling element may be a gel-based coupling element comprising gel 217, the gel including gel surface 215 and configured to transmit forces to force sensing device 210. For example, gel 217 may be a biocompatible RTV material, such as silicone. In other embodiments, the coupling element may be a mechanical coupling element, such as a stainless steel ball, an aluminum ball, or any other suitable mechanical coupling element. In some embodiments, the force sensing device 210 can be sealed to the housing 204 by, for example, assembling a radial sealing ring structure (e.g., hole 213) in the housing 204 to engage the outer diameter of the gel ring 211 on the force sensing device 210, without the need for gluing.

[0045] In some embodiments, a plurality of electrical contact pads (e.g., four electrical contact pads) may be provided on the second surface 212b of the substrate. In some embodiments, the exemplary disposable blood pressure monitoring device 200 may also include cables 214 (e.g., four cables), cable bundles 216, and electrical connection terminals 218 (e.g., a six-pin plug). For example, the plurality of electrical contact pads may be a plurality of wedge terminals 224 or may be attached to a plurality of wedge terminals 224 (e.g., four wedge terminals) configured to mechanically couple a plurality of cables 214 to a plurality of electrical contact pads.

[0046] In some implementations, the exemplary disposable blood pressure monitoring device 100 may include a digitally controlled resistor network. For example, the digitally controlled resistor network may include EEPROM circuitry configured to meet specific requirements of a force-sensing component.

[0047] In some embodiments, optional signal conditioning circuitry 220 may be configured to be electrically coupled to force sensing device 210 and a plurality of electrical contact pads, and housing 204 may also be configured to encapsulate optional signal conditioning circuitry 220. In some embodiments, when force sensing device 210 is an analog force sensing device or a digital force sensing device, optional signal conditioning circuitry 220 may be configured to be disposed on a first surface 212a of substrate 212. In some embodiments, when force sensing device 210 is a digital force sensing device, optional signal conditioning circuitry 220 may be configured to be disposed on a first surface 212a of substrate 212, and force sensing device 210 may be configured to be disposed on the top surface of optional signal conditioning circuitry 220 (e.g., optional signal conditioning circuitry 220 may be disposed below force sensing device 210 or otherwise disposed between force sensing device 210 and substrate 212).

[0048] In some embodiments, the base plate 102 may include a push structure 222 for pushing the substrate 212 to retain the gel ring 211 in the housing 204. In some embodiments, the substrate 212 may also include one or more wedge terminals 224 that have been SMT-mounted to a second surface 212b of the substrate 212. In some embodiments, the base plate 202 may also include one or more cable guides configured to support (e.g., hold in place) one or more cables engaged with one or more wedge terminals 224. The wedge terminals 224 (e.g., four wedge terminals) may be configured to act as springs to engage cables 214 (e.g., four wires), which may also be pushed and held in place by push structures 226 and 228.

[0049] In some embodiments, housing 204 may include strain relief support structure 233 configured to engage cable bundle 216, which may also be engaged by opposing strain relief support structure 234 on base plate 202. For example, strain relief support structure 233 on housing 204 and opposing strain relief support structure 234 on base plate 202 may clamp cable bundle 216 to provide strain relief.

[0050] like Figure 2B As shown, the force sensing component of an exemplary disposable blood pressure monitoring device 200 may include a force sensing device 210, an optional signal conditioning circuitry 220 (or alternatively, a digitally controlled resistor network or both), and a substrate 212. In some embodiments ( Figure 2B In (not shown), an optional signal conditioning circuit 220 may be disposed within the gel 217 (e.g., near or below the force sensing device 210). In other embodiments, such as Figure 2BAs shown, the optional signal conditioning circuit 220 can be disposed outside the gel 217 to provide the advantage of keeping the wire bond portion 223 for the optional signal conditioning circuit 220 outside the operating path. In some cases, wire bonds disposed below the gel 217 may experience fatigue failure faster than wire bonds not exposed to pressure or movement. By disposing of the optional signal conditioning circuit 220 outside the gel 217, this failure mode can be advantageously avoided. Furthermore, disposing of the optional signal conditioning circuit 220 outside the gel 217 provides greater flexibility in signal conditioning circuit upgrades to incorporate improvements in sensing or signal processing techniques.

[0051] In some embodiments, the force sensing device 210 may include a force sensing die, a gel ring 211, and a gel 217 disposed on a first surface 212a (e.g., the top surface) of a substrate 212. The gel ring 211 may be made of metal (e.g., aluminum, stainless steel) or plastic (e.g., liquid crystal polymer (LCP), polyphenylene sulfide (PPS), LCP / PPS, or any other suitable material) and is fixed to the substrate 212 using an adhesive (such as two-part epoxy). The gel ring 211 may be cylindrical and may have a 90-degree bend at its top surface to provide a 360-degree seal between the gel surface 215 of the gel 217 and the top surface of the gel ring 211. In some embodiments, an optional signal conditioning circuitry 220 (or alternatively, a digitally controlled resistor network or both) may be covered by a dome-shaped package over the wire bond portion 223 to provide protection during handling and transportation.

[0052] In some embodiments, an adhesive may be used to mount the force sensing device 210, gel ring 211, optional signal conditioning circuitry 220, or combinations thereof, onto a first surface 212a of substrate 212. In some embodiments, the adhesive may include one or more of the following: silicone, RTV silicone, silicone-epoxy, soft epoxy, conventional or hard epoxy, or any combination thereof. In one exemplary embodiment, the adhesive may include a conductive adhesive. In another exemplary embodiment, the adhesive may include a non-conductive adhesive or any combination of conductive and non-conductive adhesives. It should be understood that the adhesive is merely one example of a suitable bonding mechanism, and it is conceivable that other bonding mechanisms (e.g., but not limited to solder eutectic bonding) may be used.

[0053] In some embodiments, substrate 212 may include a PCB. In other embodiments, substrate 212 may include any suitable material, such as, but not limited to, dielectric materials, insulating materials, or any combination thereof. In one exemplary embodiment, the planar shape of substrate 212 may be polygonal, such as, but not limited to, a square, rectangle, triangle, pentagon, or any other suitable shape. In another exemplary embodiment, the planar shape of substrate 212 may be non-polygonal. In some embodiments, the planar dimensions of substrate 212 may be about 1.65 mm × 1.65 mm. In other embodiments, substrate 212 may have other suitable dimensions. In one exemplary embodiment, substrate 212 may be about 200 micrometers thick. In another exemplary embodiment, the thickness of substrate 212 may be about 300 micrometers, about 400 micrometers, about 600 micrometers, or any other suitable thickness.

[0054] In some embodiments, electrical contact pads may correspond to metal pads comprising one or more metals, such as copper (Cu), silver (Ag), gold (Au), aluminum (Al), or combinations thereof. In one exemplary embodiment, surface mount technology (SMT) can be used to surface mount the electrical contact pads onto a second surface 212b of substrate 212. In another exemplary embodiment, chemical processes can be used to chemically deposit the electrical contact pads onto the second surface 212b of substrate 212, such as, but not limited to, using a metal plating solution (such as a copper plating solution) to deposit metal onto the second surface 212b of substrate 212 to form the electrical contact pads. In yet another exemplary embodiment, the electrical contact pads can be deposited onto the second surface 212b of substrate 212 by an etching process. In other exemplary embodiments, the electrical contact pads may be disposed on a first surface 212a of substrate 212.

[0055] In some embodiments, the planar shape of each of the electrical contact pads may be polygonal, such as a triangle, rectangle, square, pentagon, hexagon, or any other suitable shape. In other embodiments, the planar shape of the electrical contact pads may be non-polygonal. In some embodiments, the planar dimensions of each of the electrical contact pads may be approximately 1.30 mm × 1.00 mm. In other embodiments, each of the electrical contact pads may have any suitable planar dimensions, such as, but not limited to, 1.23 mm × 0.95 mm, 1.35 mm × 1.05 mm, 1.58 mm × 0.75 mm, 1.63 mm × 0.80 mm, 1.68 mm × 0.85 mm, or any other suitable planar dimensions. In some embodiments, the electrical contact pads may be configured to provide an electrical connection to an external circuit. The electrical contact pads may use communication protocols to communicate with the external circuit and provide an electrical connection to the external circuit. For example, the communication protocol may include an inter-integrated circuit (I2C) protocol, a serial peripheral interface (SPI) protocol, or other communication protocols.

[0056] In some embodiments, the optional signal conditioning circuitry 220 is configured to smooth variations in the input signal to make it suitable for further processing. These variations may occur due to factors such as, but not limited to, temperature variations, external noise, electromagnetic variations, other variations, or combinations thereof. In some embodiments, the optional signal conditioning circuitry 220 may include an application-specific integrated circuit (ASIC), an instrumentation amplifier, a microprocessor, a microcontroller, or a combination thereof. In some embodiments, the optional signal conditioning circuitry 220 may also include a digital amplifier with a built-in temperature sensor (not shown) for compensating for temperature-sensitized variations caused by temperature changes.

[0057] In some embodiments, the optional signal conditioning circuit 220 may have a planar dimension of approximately 1.97 mm × 1.52 mm. In other embodiments, the optional signal conditioning circuit 220 may have any suitable planar dimension, such as, but not limited to, 1.50 mm × 1.50 mm, 1.94 mm × 1.47 mm, 2.00 mm × 1.55 mm, or any other suitable planar dimension. In one exemplary embodiment, the optional signal conditioning circuit 220 may be approximately 0.36 mm thick. In another exemplary embodiment, the optional signal conditioning circuit 220 may have a thickness of approximately 0.35 mm, 0.36 mm, or any other suitable thickness.

[0058] In some embodiments, an adhesive may be used to mount optional signal conditioning circuitry 220 onto a first surface 212a of substrate 212. Optional signal conditioning circuitry 220 may be electrically coupled to force sensing device 210 via one or more wire bonds (such as wire bonds 221 and 223). Wire bonds 221 and 223 may comprise one or more metals, such as aluminum (Al), copper (Cu), gold (Au), silver (Ag), or combinations thereof. Wire bonds 221 and 223 may be wire-bonded using suitable wire bonding techniques (e.g., thermo-ultrasonic bonding, ultrasonic bonding, thermo-press bonding, or combinations thereof). In some embodiments, each of wire bonds 221 and 223 may have a thickness of approximately 25 micrometers. In other embodiments, each of wire bonds 221 and 223 may have any other suitable thickness. It should be understood that the wire bonding portion is merely one example of establishing an electrical connection between the force sensing device 210 and the optional signal conditioning circuit 220, and it is conceivable that the optional signal conditioning circuit 220 may be electrically connected to the force sensing device 210 via other means (such as, but not limited to, trace conductors, conductive elastomer preforms, conductive adhesives, anisotropic conductive adhesives, any other suitable connectors or combinations thereof).

[0059] In some embodiments, optional signal conditioning circuitry 220 is electrically connected to force sensing device 210. In operation, optional signal conditioning circuitry 220 is configured to receive the output signal from force sensing device 210, condition the received output signal, and provide the conditioned output signal for further processing. In some embodiments, optional signal conditioning circuitry 220 may be disposed separately from force sensing device 210 on a first surface 212a of substrate 212. In other embodiments, optional signal conditioning circuitry 220 may be disposed as part of force sensing device 210 on the first surface 212a of substrate 212. In some embodiments, optional signal conditioning circuitry 220 may be disposed on top of force sensing device 210, and another circuit may be disposed below force sensing device 210 to provide additional features on a serial bus or analog signal path.

[0060] Figure 3A functional block diagram 300 is shown illustrating a method of operation of an exemplary disposable blood pressure monitoring device (e.g., exemplary disposable blood pressure monitoring device 100, exemplary disposable blood pressure monitoring device 200) according to some exemplary embodiments described herein. The exemplary disposable blood pressure monitoring device can be connected to an external circuit (not shown) via electrical contact pads. Force sensing devices (e.g., force sensing devices 110, force sensing devices 210) and optional signal conditioning circuitry (e.g., optional signal conditioning circuitry 220) can be connected via wire bonding and substrates (e.g., substrates 112, 212). In operation, an external power source can supply a power voltage to the force sensing device via the electrical contact pads. An actuator (e.g., gel 217) can apply a force to the force sensing device in response to receiving a force from an external source. The actuator can transfer the force to the force sensing device, causing a deflection in the resistance of the force sensing device. This deflection in resistance can cause a change in the output signal of the force sensing device. This change in the output signal is an indication or measurement of the force applied by the external source. The optional signal conditioning circuitry can receive the change in the output signal and adjust the received output signal.

[0061] Specific components, structures, and features of exemplary devices capable of performing some of the functions of the systems described herein have already been described. The following, in conjunction with… Figure 4 Exemplary implementations of this disclosure are described.

[0062] Figure 4 A flowchart 400 is shown, illustrating exemplary operations for providing an exemplary disposable blood pressure monitoring device according to some exemplary embodiments described herein. As shown in operation 402, the exemplary flowchart 400 may begin by setting a plurality of electrical contact pads on a second surface (e.g., second surface 112b, second surface 212b) of a substrate (e.g., substrate 112, substrate 212). The substrate may include a first surface (e.g., first surface 112a, first surface 212a) opposite the second surface. As shown in operation 404, the exemplary flowchart 400 may continue to mount a force sensing device (e.g., force sensing device 110, force sensing device 210) on the first surface of the substrate. As shown in operation 406, the exemplary flowchart 400 may continue to mount a signal conditioning circuit (e.g., optional signal conditioning circuit 220) on the first surface of the substrate. As shown in operation 408, the exemplary flowchart 400 may continue to assemble a housing (e.g., housing 104, housing 204) encapsulating at least the force sensing device and the signal conditioning circuit. The housing may define an aperture (e.g., aperture 213) for providing a coupling interface. As shown in operation 410, exemplary flowchart 400 may proceed to provide a coupling element (e.g., gel 217 disposed in gel ring 211) in the coupling interface. This coupling interface provides a path for force to be transferred to a force sensing device via the coupling element. Optionally ( Figure 4(not shown in the diagram), wherein the housing includes a snap-fit ​​structure configured to hold the force sensing device and signal conditioning circuitry within the housing, and exemplary flowchart 400 may proceed to provide attaching the housing to the base plate using the snap-fit ​​structure.

[0063] In some implementations, operations 402, 404, 406, and 408 may not necessarily be performed using... Figure 4 The sequence described in the text occurs. In some implementations, Figure 4 One or more of the operations described herein can occur substantially simultaneously. In some implementations, in Figure 4 One or more additional operations may be involved before, after, or in between any of the operations shown.

[0064] As mentioned above, Figure 4 An exemplary flowchart describing operations performed according to exemplary embodiments of the present disclosure is shown. It should be understood that each block of the flowchart, and combinations of blocks in the flowchart, can be implemented by various means, such as devices including hardware, firmware, one or more processors, and / or circuitry associated with the execution of software including one or more computer program instructions. For example, one or more of the processes described above can be executed by a material handling apparatus (e.g., a robotic arm, servo motor, motion controller, etc.) and computer program instructions residing on a non-transitory computer-readable storage memory. In this regard, the computer program instructions embodying the processes described above can be stored in the memory of a device employing embodiments of the present disclosure and executed by the processor of the device. It is understood that any such computer program instructions can be loaded onto a computer or other programmable device (e.g., hardware) to produce a machine, such that the resulting computer or other programmable device provides an implementation of the functions specified in the flowchart blocks. When executed, the instructions stored in the computer-readable storage memory produce an article of manufacture configured to implement the various functions specified in the flowchart blocks. Furthermore, executing the computer or other processing circuitry to perform the various functions transforms the computer or other processing circuitry into a specific machine configured to perform the exemplary embodiments of the present disclosure.

[0065] Therefore, the described flowchart blocks support combinations of means for performing a specified function and combinations of operations for performing a specified function. It will also be understood that one or more flowchart blocks and combinations of flowchart blocks can be implemented by a combination of a dedicated hardware-based computer system that performs the specified function or dedicated hardware that executes computer instructions. For example, in one or more exemplary embodiments, the function described herein can be implemented by a combination of dedicated hardware or hardware programmed by firmware or other software. In firmware- or other software-dependent implementations, these functions can be performed by the execution of one or more instructions stored on one or more non-transitory computer-readable media and / or one or more non-transitory processor-readable media. These instructions can be embodied by one or more processor-executable software modules residing on one or more non-transitory computer-readable or processor-readable storage media. In this regard, non-transitory computer-readable or processor-readable storage media can include any storage medium accessible by a computer or processor. By way of example and not limitation, such non-transitory computer-readable or processor-readable media can include RAM, ROM, EEPROM, flash memory, disk storage devices, magnetic storage devices, etc. As used herein, disk storage devices include compressed optical discs (CDs), laser discs, optical discs, digital versatile optical discs (DVDs), floppy disks, and Blu-ray discs. TM (Blu-ray discs), or other storage devices that store data magnetically or optically using lasers. Combinations of the above types of media are also included within the scope of the terms non-transitory computer-readable and processor-readable media. Additionally, any combination of instructions stored herein on one or more non-transitory processor-readable or computer-readable media may be referred to as a computer program product.

[0066] In some example implementations, some of the operations described herein may be modified or further amplified as described below. Furthermore, in some implementations, additional optional operations may be included. It should be understood that each of the modifications, optional additions, or amplifications described herein may be included in the operations herein, either individually or in combination with any other feature described herein.

[0067] The foregoing method descriptions and process flowcharts are provided as illustrative examples only and are not intended to require or imply that the steps of the various embodiments must be performed in the presented order. As those skilled in the art will understand, the order of steps in the above embodiments can be performed in any order. Words such as “after,” “then,” “next,” and similar terms are not intended to limit the order of steps; these words are merely used to guide the reader through the description of the method. Furthermore, any reference to singular claim elements, for example, using the articles “a,” “an,” or “the,” should not be construed as limiting the element to the singular and, in some cases, may be interpreted in the plural form.

[0068] As mentioned above and referring to Figures 1 to 20 Figure 4 Therefore, the exemplary embodiments of this disclosure thus provide an exemplary disposable blood pressure monitoring device. Consequently, the exemplary disposable blood pressure monitoring device disclosed herein can easily and cost-effectively meet all performance requirements and is also sufficiently sensitive to detect blood pressure.

[0069] Although various embodiments based on the principles disclosed herein have been shown and described above, modifications can be made thereto by those skilled in the art without departing from the teachings of this disclosure. The embodiments described herein are representative only and not intended to be limiting. Many variations, combinations, and modifications are possible and are within the scope of this disclosure. Alternative embodiments resulting from the merging, integration, and / or omission of features of the embodiments are also within the scope of this disclosure. Therefore, the scope of protection is not limited by the description given above, but is defined by the following claims, which include all equivalents of the subject matter of the claims. Each claim is incorporated into the specification as further disclosure, and the claims are embodiments of this disclosure. Furthermore, any of the foregoing advantages and features may relate to specific embodiments, but the application of such published claims should not be limited to methods and structures that achieve any or all of the above advantages or have any or all of the above features.

[0070] Furthermore, the section headings used herein are intended to align with or provide organizational clues for the recommendations of 47 C. FR § 1.77. These headings should not limit or characterize the disclosure set forth in any of the claims published in this disclosure. For example, the description of the technology in “Background Art” should not be construed as an admission that a particular technology is prior art to any disclosure in this disclosure. Nor should “Summary of the Invention” be considered a limiting characterization of the disclosure set forth in the published claims. Furthermore, any reference in this disclosure to the singular forms of “Disclosure” or “Simplification” should not be used to prove that there is only one novel point in this disclosure. Multiple embodiments of this disclosure may be set forth according to the limitations of the multiple claims published in this disclosure, and such claims accordingly define the disclosure protected by them and their equivalents. In all cases, the scope of these claims should be considered in accordance with the advantages of the claims themselves, and should not be limited by the headings set forth herein.

[0071] Furthermore, without departing from the scope of this disclosure, technologies, systems, subsystems, and methods described and illustrated as separate or independent in the various embodiments may be combined or integrated with other systems, modules, technologies, or methods. Other devices or components shown or discussed as interconnected or communicating with each other may be indirectly interconnected through some intermediate devices or components, whether such interconnection is made electrically, mechanically, or otherwise. Other examples of variations, substitutions, and modifications that can be identified by those skilled in the art without departing from the scope of this disclosure will also be provided.

[0072] Those skilled in the art to which these embodiments pertain will conceive of numerous modifications and other embodiments of the disclosure set forth herein, which benefit from the teachings presented in the foregoing description and associated drawings. Although the drawings show only certain components of the apparatuses and systems described herein, it should be understood that various other components may be used in conjunction with the components and structures disclosed herein. Therefore, it should be understood that this disclosure is not limited to the specific embodiments disclosed, and modifications and other embodiments are intended to be included within the scope of the appended claims. For example, various elements or components may be combined, rearranged, or integrated into another system, or certain features may be omitted or not implemented. Furthermore, the steps in any of the methods described above may not necessarily occur in the order depicted in the drawings, and in some cases, one or more of the depicted steps may occur substantially simultaneously, or additional steps may be involved. Although specific terminology is used herein, it is used only in a descriptive sense and not for limiting purposes.

Claims

1. A device for sensing a force applied by an external source in a fluid monitoring tube, the device comprising: Force sensing devices; A signal conditioning circuit, the signal conditioning circuit being configured to be electrically coupled to the force sensing device; and A housing configured to enclose the force sensing device and the signal conditioning circuitry. The housing includes a snap-fit ​​structure configured to attach the housing to a base plate and retain the force sensing device and the signal conditioning circuit within the housing. The housing defines a coupling interface configured to provide a path for the force to be transferred from the fluid monitoring tube to the force sensing device via the coupling element. The base plate includes one or more pushing structures configured to push the base plate to press the annular structure of the force sensing device into the coupling interface of the housing.

2. The apparatus according to claim 1, wherein, The coupling interface is a hole in the housing.

3. The apparatus according to claim 1, wherein, The force sensing device includes an annular ring structure with an outer diameter.

4. The apparatus according to claim 1, wherein, The force sensing device is configured to be disposed on a first surface of the substrate.

5. The apparatus according to claim 4, wherein, The force sensing device includes a pressure range gauge sensing die, which is adhered to a first surface of the substrate.

6. The apparatus according to claim 1, wherein, The annular ring structure is coupled to the first surface of the substrate, such that the pressure range gauge sensing die is positioned within the annular ring structure.

7. The apparatus according to claim 4, wherein, The substrate includes a second surface opposite to the first surface, wherein the signal conditioning circuit is configured to be disposed on the first surface of the substrate, and wherein the device further includes: A plurality of electrical contact pads are disposed on the second surface of the substrate; and Multiple wedge terminals are configured to mechanically couple multiple cables to the multiple electrical contact pads.

8. The apparatus according to claim 1, wherein, The coupling element is a gel-based coupling element containing a gel.

9. A system for sensing a force applied by an external source in a fluid monitoring tube, the system comprising: Force sensing component, the force sensing component comprising: Force sensing devices; A signal conditioning circuit, configured to be electrically coupled to the force sensing device; and A substrate, the substrate including a first surface and a second surface opposite to the first surface. The force sensing device and the signal conditioning circuit are each disposed on a first surface of the substrate, and a plurality of electrical contact pads are disposed on a second surface of the substrate; and A housing configured to enclose the force sensing component; Base plate, The base plate includes one or more pushing structures configured to push the base plate to press the annular structure of the force sensing device into the coupling interface of the housing.

10. A device for sensing a force applied by an external source in a fluid monitoring tube, the device comprising: Force sensing devices; A signal conditioning circuit, the signal conditioning circuit being configured to be electrically coupled to the force sensing device; A housing configured to enclose the force sensing device and the signal conditioning circuitry. The housing includes a snap-fit ​​structure configured to attach the housing to a base plate and retain the force sensing device and the signal conditioning circuit within the housing. The housing defines an aperture configured to provide a gel-based coupling interface, which is configured to provide a path for the force to be transferred to a force sensing device via a coupling element. The base plate includes a pushing structure that pushes the substrate to hold the gel ring of the force sensing device into the housing, and the gel ring is fitted into the mating hole of the fluid monitoring tube.

11. The apparatus according to claim 10, wherein, The housing also includes a strain relief support structure configured to engage the cable bundle.

12. A method of manufacturing an apparatus for sensing a force applied by an external source in a fluid monitoring tube, the method comprising: The force sensing device is mounted on the surface of the substrate; The signal conditioning circuit is mounted on the surface of the substrate; Assemble a housing that encloses at least the force sensing device and the signal conditioning circuitry, wherein the housing includes a snap-fit ​​structure configured to retain the force sensing device and the signal conditioning circuitry within the housing; and The outer casing is attached to the base plate using the aforementioned snap-fit ​​structure. The base plate includes a pushing structure that pushes the substrate to hold the gel ring of the force sensing device into the housing, and the gel ring is fitted into the mating hole of the fluid monitoring tube.

13. A device for sensing a force applied by an external source in a fluid monitoring tube, the device comprising: Force sensing devices; A signal conditioning circuit, the signal conditioning circuit being configured to be electrically coupled to the force sensing device; and A housing configured to enclose the force sensing device and the signal conditioning circuitry. The housing includes a snap-fit ​​structure configured to attach the housing to a base plate and retain the force sensing device and the signal conditioning circuit within the housing. The housing defines a coupling interface configured to provide a path for the force to be transferred from the fluid monitoring tube to the force sensing device via the coupling element. The force sensing device includes an annular ring structure with an outer diameter, and The coupling interface is a radial sealing ring structure, configured to engage the outer diameter of the annular ring structure of the force sensing device, and The base plate includes one or more pushing structures configured to push the base plate to press the annular ring structure of the force sensing device into the coupling interface of the housing.

14. A system for sensing a force applied by an external source in a fluid monitoring tube, the system comprising: Force sensing component, the force sensing component comprising: Force sensing devices; A signal conditioning circuit, configured to be electrically coupled to the force sensing device; and A substrate, the substrate including a first surface and a second surface opposite to the first surface. The force sensing device and the signal conditioning circuit are each disposed on a first surface of the substrate, and a plurality of electrical contact pads are disposed on a second surface of the substrate; and The force sensing device includes an annular ring structure with an outer diameter; and A housing configured to enclose the force sensing component. The housing defines a coupling interface, and The coupling interface is a radial sealing ring structure, configured to engage the outer diameter of the annular ring structure of the force sensing device, and Base plate, The base plate includes one or more pushing structures configured to push the base plate to press the annular ring structure of the force sensing device into the coupling interface of the housing.

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