Patient-worn sensors including compliant flexible printed circuit components

Abstract

A patient monitoring device includes an adapter having a flexible printed circuit and a connector, the flexible printed circuit including a rigid portion with a rigid reinforcement and a flexible portion with a trace, the connector connected to one end of the trace, the connector being movable in two or three dimensions independently of the rigid portion, and the connector being connectable to an electrode assembly.

Description

[0001] Background of the Invention

[0002] 1. Field of the Invention

[0003] The present invention relates to a patient-worn sensor monitoring device comprising an electrode assembly which, in use, is temporarily secured or attached to the patient's skin.

[0004] 2. Description of Related Technology

[0005] Many different types of patient monitoring systems require a direct electrical interface to the patient's skin. In some applications, the direct electrical interface to the patient's skin is used to sense electrical signals present at the skin location; while in other applications, the direct electrical interface is used to apply an electrical current stimulation signal at the skin location. Therefore, patient monitoring systems generally require a patient-worn sensor assembly that detects, records, and transmits patient data. Therefore, the patient-worn sensor assembly can include several structural features that can provide improved signal quality, reduction in signal noise, improved patient comfort, improved reliability, and improved adhesion to the patient's skin.

[0006] Sensors worn by patients can receive vital sign information such as blood pressure, body temperature, respiratory rate, blood oxygen, electrocardiogram (ECG), heart rhythm, heart rate, blood sugar level and hydration (bioimpedance) level, etc. Sensors worn by patients can also track and record other information about the patient, including the patient's movement, activity and sleep patterns.

[0007] Conventional patient-worn sensors collect information sensed at the patient's skin and transmit the data wirelessly to another device of the monitoring system (e.g., a bedside monitor, a tablet device, a mobile phone, a central processing server, etc.), which in turn can be connected to a network system of a hospital, clinic, or home-based monitoring system. Such patient-worn sensors may include: an adhesive electrode assembly having multiple individual electrodes attached to the patient's skin and a sensor assembly including all sensing, processing, and transmission electronics and a power source in a stand-alone sensor-transmitter device. In such conventional sensor-transmitter devices, the electrode assembly provides a direct electrical interface, adhesion to the patient's skin, and a platform to connect and support the sensor assembly.

[0008] Conventional skin electrode assemblies are connected to a monitoring system via electrical leads (i.e., long wires) and are intended for use with a patient who is "tethered" to the monitoring system. In such conventional skin electrode assemblies, the assembly worn by the patient typically includes an electrode assembly having one or more electrodes that can be attached to the patient's skin and an associated connector assembly having an associated number of contacts for the one or more electrodes of the electrode assembly. The connector assembly can be connected to the monitoring system leads to provide an electrical connection between the one or more electrodes of the electrode assembly and the sensing and processing circuitry of the monitoring system.

[0009] All patient-worn sensors should be comfortable for the patient. In addition, the components should be flexible, small in size, chemically inert, resistant to disinfectants, non-toxic, hypoallergenic to humans, easy to use, strong enough to withstand the impact of being dropped, and provide one or more methods for attachment to the patient. In addition to complying with these considerations, conventional patient-worn sensors may have adhesion problems and electrical contact problems. That is, patient-worn sensors need to be reliable and maintain contact with the patient under all standard conditions of use (including, for example, during patient movement). In addition, patient-worn sensors need to minimize changes across electrodes caused by patient movement that causes mechanical stress on the electrodes or patient contact points.

[0010] In known two-piece patient-worn sensors that include a sensor attached to an adapter that is attached to the patient's skin via adhesive monitoring electrodes, a user or caregiver may need to remove the sensor from the adapter to replace a low battery, but leave the adapter on the patient. Typically, a person removes the sensor by grasping the sensor with one hand while holding the adapter with the other hand and pulling the sensor and adapter apart from each other. As a result, when the sensor is disengaged from the adapter, one of the user's hands may come into contact with the patient's face due to the large disengagement force required to pull the sensor and adapter apart. Summary of the invention

[0011] In order to overcome the above problems, a preferred embodiment of the present invention provides a patient monitoring device, which includes push tabs on the sensor and the adapter to facilitate disconnection of the sensor and the adapter. In addition, a preferred embodiment of the present invention provides a patient monitoring device, which includes a flexible printed circuit, the flexible printed circuit includes a rigid portion with a reinforcement, wherein the electrical component is connected to the flexible printed circuit, and the flexible printed circuit includes a flexible portion without a reinforcement to allow the flexible portion to move in two or three dimensions.

[0012] According to a preferred embodiment of the present invention, a patient monitoring device includes an adapter having a flexible printed circuit, the flexible printed circuit including a rigid portion having a rigid reinforcement and a flexible portion having a trace, and the adapter having a connector connected to one end of the trace, the connector being movable in two or three dimensions independently of the rigid portion, and the connector being connectable to an electrode assembly.

[0013] The rigid reinforcement preferably overlaps the electronic components on the flexible printed circuit. Preferably, the flexible portion extends from the rigid portion and has a zigzag shape. The flexible portion preferably extends from the rigid portion, wherein there is a gap between the flexible portion and the rigid portion. The flexible portion preferably extends from the rigid portion in a straight portion. The flexible portion preferably extends from the rigid portion in a straight portion and terminates in a spiral portion.

[0014] The flexible printed circuit preferably includes an additional rigid portion including an additional rigid reinforcement. Preferably, the patient monitoring device also preferably includes: a sensor assembly that can be connected to and disconnected from the adapter; a rigid circuit board connected to the additional rigid portion; and a sensor connector connected to the rigid circuit board, wherein the sensor connector can be connected to and disconnected from the sensor assembly.

[0015] The patient monitoring device also preferably comprises an electrode assembly attachable to the patient.The connector is preferably rotatable in two or three dimensions independently of the rigid portion.

[0016] The patient monitoring device also preferably includes a sensor assembly that is connectable to and disconnectable from the adapter. The sensor assembly preferably includes a gripper that facilitates gripping the second electronic assembly during connection and disconnection of the sensor assembly from the adapter. The adapter and the sensor assembly each preferably include a push tab that facilitates connection or disconnection of the adapter and the sensor assembly. The push tab of the sensor assembly is preferably laterally offset relative to the push tab of the adapter.

[0017] According to a preferred embodiment of the present invention, a patient monitoring device comprises: an adapter, the adapter comprising a first push piece; and a sensor assembly, the sensor assembly being connected to the adapter and comprising a second push piece. The adapter and the sensor assembly are separated by applying force to the first push piece and the second push piece in opposite directions.

[0018] The first push tab and the second push tab are preferably laterally offset. The first push tab and the second push tab are preferably laterally offset so that a user's left thumb and left index finger can be used to separate the adapter and the sensor assembly. Preferably, one of the adapter and the sensor assembly includes an arm, and the other of the sensor assembly and the adapter includes a ledge that can engage with the arm. Each of the arms preferably includes a slot to receive a respective ledge. The sensor assembly preferably includes a gripper to facilitate gripping the sensor assembly.

[0019] According to a preferred embodiment of the present invention, a patient monitoring device includes an adapter, the adapter includes a flexible printed circuit, the flexible printed circuit has a rigid portion, the rigid portion includes a rigid reinforcement, the adapter includes a connector, the connector can be connected to an electrode assembly, and the adapter includes a discrete wire, the discrete wire connects the flexible printed circuit and the connector. The connector can be moved in two or three dimensions independently of the rigid portion.

[0020] Preferably, the patient monitoring device further comprises an electrode assembly attachable to the patient.The connector is preferably rotatable in two or three dimensions independently of the rigid portion.

[0021] According to a preferred embodiment of the present invention, a patient monitoring device includes an adapter, the adapter having a flexible printed circuit, the flexible printed circuit including a rigid portion and a flexible portion, the rigid portion including a rigid reinforcement, the flexible portion including a trace and extending from the rigid portion, wherein there is a gap between the flexible portion and the rigid portion, and the adapter has a connector connected to one end of the trace and capable of being connected to an electrode assembly.

[0022] The above and other features, elements, characteristics, steps and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the present invention with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A patient-worn sensor in contact with a patient is shown according to a preferred embodiment of the present invention.

[0024] Figure 2 A patient-worn sensor according to a preferred embodiment of the present invention is shown.

[0025] Figure 3 A sensor according to a preferred embodiment of the present invention is shown.

[0026] Figure 4 An adapter according to a preferred embodiment of the present invention is shown.

[0027] Figure 5 and Figure 6A front view and a rear view of a sensor according to a preferred embodiment of the present invention are shown respectively.

[0028] Figure 7 and Figure 8 A front perspective view and a rear perspective view of an adapter according to a preferred embodiment of the present invention are shown, respectively.

[0029] Fig. 9 A partially exploded view of an adapter according to a preferred embodiment of the present invention is shown.

[0030] Fig.10 A flexible printed circuit according to a preferred embodiment of the present invention is shown.

[0031] Fig.11 A plan view of a flexible printed circuit according to a preferred embodiment of the present invention is shown.

[0032] Figures 12 to 16 A plan view showing an example of a flexible printed circuit according to a preferred embodiment of the present invention. DETAILED DESCRIPTION

[0033] Figure 1 A patient-worn sensor 102 is shown secured to a patient 104. Figure 1 In the example shown, the patient-worn sensor 102 is attached to the chest of the patient 104. However, the patient-worn sensor 102 can be fixed to one or more other areas on the body of the patient 104. The patient-worn sensor 102 can detect, record, store and transmit various vital signs and other information of the patient 104 or another patient with which the patient-worn sensor 102 is in contact. For example, the patient-worn sensor 102 may include several adhesive electrodes that contact the skin of the patient 104 to measure various biological information, vital signs and patient information, including but not limited to heart rhythm, heart rate, blood pressure, body temperature, respiratory rate, blood oxygenation, blood sugar level, hydration level, perspiration and bioimpedance. The patient-worn sensor 102 can also track the patient's movement, movement, activity, position, posture and physical position.

[0034] The sensor 102 worn by the patient can also communicate with one or more other computing devices via wired or wireless communications. For example, the sensor 102 worn by the patient can use Bluetooth, WiFi or cellular communication protocols to communicate with other computing devices such as bedside monitors, personal computers, tablet devices, mobile phones, central servers or cloud-based networks. As an example, the sensor 102 worn by the patient can transmit the vital signs information collected from the patient 104 to a tablet device or personal computer used as a bedside monitor. The tablet computer or personal computer can process the received information and display the information to a caregiver or other user in a readable and understandable format. For example, the tablet device can receive vital signs information from the sensor 102 worn by the patient via Bluetooth connection and display the patient's electrocardiogram (ECG) waveform and information about the patient's heart rate, respiratory rate, blood oxygen level, body temperature and / or other vital signs. As another example, the patient-worn sensor 102 may be periodically connected to a computing device (e.g., a bedside monitor) via a wired connection to allow information collected by the patient-worn sensor 102 to be stored, processed, and displayed by the computing device and / or transferred to one or more other computing devices (e.g., a personal computer, a server located at a hospital, a cloud storage server, etc.).

[0035] In addition, the information recorded by the sensor 102 worn by the patient can be transmitted to other computing devices for both real-time analysis or near real-time analysis of the patient's 104 condition and for tracking the patient's 104 vital signs information over time. For example, the information recorded by the sensor 102 worn by the patient can be transmitted to a display device to allow a caregiver to observe the information and make adjustments to the patient care of the patient 104 based on the information. The information can also be transmitted to a central information repository to allow the patient's historical vital signs information and other information to be recorded. Both the patient's real-time vital signs information and historical vital signs information and other information can be accessed by a caregiver who is not at the same physical location as the patient. For example, the vital signs information collected by the sensor 102 worn by the patient can be transmitted to a mobile device (e.g., a smart phone) owned by the patient 104 to allow the patient 104 to view the information. The information can also be transmitted to a central server (e.g., using a personal computer or mobile device) that can be accessed by one or more caregivers to allow the caregiver to view the collected information and make patient care decisions for the patient 104 from a location away from the patient 104.

[0036] Other components that can be included as part of the sensor 102 worn by the patient include a power source, a button or other input mechanism for receiving user input, one or more audible alarms or speakers, and a light or display screen. The power source for the sensor 102 worn by the patient can be a battery pack that accepts standard disposable batteries, a rechargeable battery, or a detachable battery pack that can be replaced with a fully charged battery pack. The sensor 102 worn by the patient can also include an input mechanism, such as a button, a key, or a touch screen. The input mechanism can allow the patient 104 or a caregiver to adjust the settings for the sensor 102 worn by the patient, perform various tests (such as sensor tests, battery power level tests, etc.) or reset one or more alarms of the sensor 102 worn by the patient. If the patient 104 needs help, the input mechanism can also allow the patient 104 (for example, to a caregiver or to a hospital alarm system) to issue a call for help.

[0037] Figure 2 is a perspective view of an exemplary patient-worn sensor 202. Figure 2 As shown, the patient-worn sensor 202 may include a sensor 210 coupled to an adapter 220. The adapter 220 may include a socket 221 that may be connected to a different sensor (not shown). The adapter 220 may include any number and type of sockets 221.

[0038] Figure 3 and Figure 4 3 and 4 are perspective views of an exemplary sensor 310 and an exemplary adapter 320, respectively. Figure 3 As shown, the sensor 310 may include an electrical connector 315, a push piece 316, a ledge 317, a clamping grip 318, and a socket 319. The connector 315 is inserted into the socket connector 325 of the adapter 320 and is used to send and receive power and electrical signals between the sensor 310 and the adapter 320. The push piece 316 of the sensor 310 and the push piece 326 of the adapter 320 can be used to connect and disconnect the sensor 310 and the adapter 320. The ledge 317 can be located on opposite sides of the sensor 310 and can be engaged with corresponding arms 327 of the adapter 320. The ledge 317 and the arm 327 can be used to align the sensor 310 with the adapter 320 and to secure the sensor 310 to the adapter 320. The sensor 310 may include a clamping grip 318 on the opposite side, which allows the user or caregiver to more easily grasp the sensor 310. In Figure 3In the embodiment of the present invention, the clamping gripper 318 includes three ridges, but any number and type of grippers may be used. Alternatively, no grippers may be used at all. The sensor 310 may include a socket 319 that may be used to charge the sensor 310 or to send / receive data when the sensor 310 is not connected to the adapter 320. For example, the socket 319 may be used to send / receive data to an electronic device that is not the adapter 320.

[0039] like Figure 4 As shown, the adapter 320 may include a socket connector 325, a push piece 326, an arm 327, and a socket 329. The socket connector 325 may receive the connector 315. Instead of the socket connector 325 being located on the adapter 320 and the connector 315 being located on the sensor, the socket connector may be located on the sensor 310 and the connector may be located on the adapter 320. The push piece 326 may be used with the push piece 316 to couple and disconnect the sensor 310 with the adapter. The arm 327 may be located on the opposite side of the adapter 320 and may be used with the ledge 317 to align and secure the sensor 310. As shown in FIG. Figure 4 As shown, arm 327 may include a slot to receive ledge 317. Any arrangement and type of arm may be used. Instead of arm 327 being located on adapter 320 and ledge 317 being located on sensor 310, the arm may be located on sensor 310 and the ledge may be located on adapter 320. Socket 329 may be used to connect another electronic device, such as a patient-worn sensor, a finger-worn sensor, a wrist sensor, a battery charger, a computing device, etc.

[0040] Figure 5 is a front view of an exemplary sensor 400 and Figure 6 is a rear view of the sensor 400 . Figure 5 and Figure 6 A connector 410 for mechanically and electrically connecting to the adapter and two gripping grips 420 are shown, one on each side of the sensor 400 to help a user grasp and grip the sensor 400 when inserting and removing the sensor 400 from the adapter. As shown, the grips 420 are defined by a series of ridges or protrusions in the surface of the housing of the sensor 400, but other suitable features are possible. Figure 5 Also shown is a push tab 430 on the front surface of the sensor 400, which can help a user apply an insertion force or a separation force when inserting the sensor 400 or removing the sensor 400 from the adapter.

[0041] also, Figure 5 Two ledges 440 are shown, one on each side of the sensor 400, which are used to interlock with the arms on the adapter ( Figure 7 as shown) to hold the sensor 400 and the adapter together.

[0042] Figure 7 and Figure 8 4 and 5. These are front and rear perspective views of the adapter 500, respectively. Figure 7 Adapter 500 is shown to include additional sockets 510 and 520 that can be used to access and connect internal electronics via direct wiring or connectors. As shown, socket 510 is on the bottom of adapter 500, and socket 520 is on the right side, but other locations are possible.

[0043] also, Figure 7 The adapter 500 is shown to include two arms 540, one on each side of the adapter 500. As shown, the arms 540 may include inwardly facing grooves and recesses that help align and secure the sensor when inserting and removing the sensor from the adapter 500. The grooves and / or recesses in the arms 540 may engage with ledges on the sides of the sensor to interlock with the ledges to hold the sensor and adapter 500 together.

[0044] Figure 7 Also shown is a push tab 530 on the front surface of the adapter 500, which can be used to help the user apply an insertion force or a separation force when inserting or removing the sensor from the adapter 500. Figure 2 As shown, the push tabs on the front surfaces of the sensor 210 and the adapter 220 are laterally offset from each other so that a user can access both sides of the push tabs to use a thumb and finger to push the sensor 210 and the adapter 200 together or push the sensor 210 away from the adapter 200 when inserting or removing the two devices.

[0045] When the user attempts to remove the sensor from the adapter, he or she can place fingers (including the thumb) on the push piece and push them in opposite directions to easily disengage the sensor. More specifically, the user can place the left thumb on the bottom side of the push piece of the sensor and the left index finger on the top side of the push piece of the adapter while holding the sensor gripper with the right thumb and the right index finger. Then, through the twisting motion of the left fingers and thumb, the push pieces are pushed away from each other so that the sensor is removed from the adapter in a safe manner. In order to encourage the user to grasp the sensor with the right hand while manipulating the push piece with the left hand, the push piece on the sensor can be positioned to the left of the push piece on the adapter. Assuming that the sensor worn by the patient is in contact with the left side of the patient's chest (which is usually the case), using the user's right hand to remove the sensor makes it less likely that the user will hit the patient's face when removing the sensor compared to using the user's left hand.

[0046] Figure 8 The rear perspective view of FIG. 5 shows the arm 540 and the socket 520 on the adapter 500. In addition, Figure 8 The adapter 500 is shown to include two stabilizing shields 550, but other numbers are possible. The stabilizing shields 550 extend from the adapter 500 so that each stabilizing shield can surround the electrical contacts by way of the snap connector 555. The stabilizing shields 550 can absorb impacts to the adapter 500 caused by the patient's movement to provide a more stable signal through the snap connector 555. The stabilizing shields 550 can also absorb movement caused by flexion of the patient's skin, and can absorb impacts caused by movement caused by other movements of the patient (e.g., walking, running, rolling over, etc.). In addition, the stabilizing shields 550 can also absorb transient mechanical impacts to the snap connector 555 and the internal coupling traces caused by snapping and unsnapping the mating snap connector.

[0047] The stabilizing cover 550 can absorb the impact caused by the movement of the patient while still allowing a certain degree of compliance in the X, Y and Z directions and around the X, Y and Z directions. The stabilizing cover 550 can provide the stability of the connection between the sensor worn by the patient, the snap connector 555 and the adhesive pad connected to the patient by the following operation: compared with the X-axis direction and the Y-axis direction of the sensor worn by the patient, the Z-axis direction of the sensor worn by the patient provides a greater degree of movement relative to the patient. The Z-axis can be, for example, a direction substantially perpendicular to the patient's skin (and thus the contact surface of the adhesive electrode pad), while the X-axis direction and the Y-axis direction are substantially parallel to the patient's skin (and thus the contact surface of the adhesive electrode pad). When in use, the adhesive side of the adhesive electrode pad portion of the sensor worn by the patient is fixed to the patient, and the other side of the adhesive electrode pad is attached to the sensor worn by the patient by means of a disposable snap connector of the electrode of the adhesive electrode pad engaged with the electrical contact 555. Once the sensor worn by the patient is attached to the patient, the patient can move freely, which may cause the relative position of the contact point on the patient's skin that the electrode of the adhesive electrode pad contacts the patient to shift. Stabilizing shield 550 can absorb some or all of the motion caused by the patient's movement, thereby reducing the negative impact on the integrity and quality of the signal received by the electrodes of the adhesive electrode pad. In some implementations, stabilizing shield 550 extends beyond electrical contacts 555 to at least partially surround a portion of the electrodes of the adhesive electrode pad.

[0048] The stabilizing shield 550 may be formed using an overmolding process such that the stabilizing shield 550 is integrated as a unitary piece with a portion of the housing of the adapter 500. The overmolding process allows the stabilizing shield 550 to be formed from a material that is less rigid than the material used to form other portions of the adapter housing, while still allowing the stabilizing shield 550 to be defined as a unitary piece that is integrated with at least a portion of the adapter housing. For example, the stabilizing shield 550 may be defined from a thermoplastic elastomer (TPE) material using an overmolding process.

[0049] Fig. 9 An exploded view of the components of adapter 600 is shown with the top housing removed. Fig. 9 The components of the adapter 600 shown include a bottom housing 610, a snap connector 620, a flexible printed circuit (FPC) 630, and a connector board 640 including a connector 650. As shown, the bottom housing 610 may include components for mounting and securing the adapter 600 and a top housing ( Fig. 9 Structural features not shown).

[0050] The top and bottom shells 610 can be made of molded plastic or other materials that are suitably lightweight to facilitate easy attachment to the patient and the sensor, while also being structurally strong enough to protect the internal components of the adapter 600 from damage if the adapter 600 or the sensor worn by the patient is dropped. The top and bottom shells 610 can be, for example, plastic injection molded components molded from a high-impact plastic such as polycarbonate (PC), acrylonitrile butadiene styrene (ABS), or an ABS / PC blend. The top and bottom shells 610 can also be joined to each other with a watertight or semi-watertight seal to prevent moisture from reaching the internal components of the adapter 600.

[0051] like Fig. 9 As shown, the bottom housing 610 may include two recesses for positioning and aligning two snap connectors 620, which are supported by a stabilizing cover 550 protruding from the rear of the bottom housing 610, as shown in FIG. Figure 8 The snap connector 620 can mate with a corresponding snap connector of an electrical device, such as a sensor or disposable electrode, connected to the patient to form both a mechanical connection and an electrical connection between the electrical device and the adapter 600. In addition, a corresponding mating snap connector forms an electrical connection with each connection of each of the snap connectors 620 to send and receive signals from the electrical device to the processing components of the FPC 630.

[0052] FPC 630 may include a rigid part with various processing components implemented as integrated circuit chips and / or other electronic components (not shown). Therefore, FPC 630 may be made of polyimide or any other suitable material. FPC 630 may include passive components such as resistors, and may transmit signals. FPC 630 may also include active components such as one or more processors that can process signals received from patients, and may include one or more communication modules to communicate with other computing devices using one or more communication protocols (e.g., Bluetooth, WiFi, cellular communications, etc.). Other components that may be included in the circuit system of FPC 630 are interface circuits for docking with electronic devices such as sensors, one or more accelerometers, GPS or other position detection circuits, temperature sensors for sensing ambient temperature, light sensors for sensing ambient light, and output circuits for outputting information to users by controlling output devices such as lights, speakers, sound alarms, display screens, etc.

[0053] The FPC 630 may also include a flexible portion 635 aligned with each of the snap connectors 620. The flexible portion 635 includes traces connected to the snap connectors. Each flexible portion 635 is aligned with a snap connector 620 that receives a mating snap connector of an electrical device such as a sensor that can be connected to a patient or an electrode that can be connected to a patient. Instead of using the flexible portion 635, a discrete wire may be used to connect the FPC 630 to the snap connector 620.

[0054] Instead of bending a portion of the FPC 630 (e.g., bending 180°) to allow the FPC 630 to connect to the sensor, the FPC 630 may use a connector plate 640 and a connector 650. The connector plate 640 may be electrically connected directly to the FPC 630 by soldering, by discrete wiring, or via an additional stacking connector. The connector plate 640 is preferably a rigid printed circuit board (PCB), but may be a flexible circuit board or any other suitable substrate.

[0055] The flexible portion 635 is used to absorb the movement of the snap connector 620 after any patient skin movement. However, trace disconnection problems may occur near mounted electronic components due to high stress concentration caused by inadvertent bending or improper handling of the FPC 630 during the assembly process. To prevent trace fatigue or damage problems, reinforcements may be added to the portion of the FPC 630 where the electronic components are mounted.

[0056] Fig.10 The left hand portion shows Fig. 9 The FPC 630 includes a portion of the FPC 630 within the circle A connected to the connector board 640. Fig.10The right hand portion of FIG. 6 shows an enlarged circle A. As shown in the enlarged area, the FPC 630 may include a reinforcement 637 adhered to the underside of the FPC 630, overlapping the area to which the connector board 640 is attached. The reinforcement 637 is harder than the material of the FPC 630 and adds mechanical strength to the portion of the FPC 630 to which the reinforcement 637 is attached. The added reinforcement 637 eliminates or minimizes the problem of trace fatigue or damage during handling and assembly. The reinforcement 637 may be made of a glass reinforced epoxy laminate such as FR4, G10, or any other suitable material. Within manufacturing tolerances, the reinforcement may be approximately 0.4 mm thick, or may be any other suitable thickness.

[0057] Fig.11 is with Fig. 9 and Fig.10 800 is a plan view of an FPC 800 similar to the FPC 800 shown in FIG. This view shows that reinforcements can be added in contour areas 836 and 838 that include electrical components and are used to increase mechanical strength and integrity. Within manufacturing tolerances, the reinforcements can be approximately 0.2 mm thick, or can be any other suitable thickness.

[0058] Another problem may arise from trace fatigue in the FPC caused by forces from the stabilizing shield through the snap connector during repeated movement of the stabilizing shield caused by patient skin movement or snapping and unsnapping of the mating snap connector. Trace fatigue can cause intermittent contact or complete disconnection of the FPC and associated circuitry with the snap connector, the mating snap connector, and the electronic device (e.g., sensor). This problem can be eliminated or minimized by using a different trace routing configuration in the FPC. Figure 12 to Figure 14 Shown are plan views of examples of FPCs with different possible trace routing configurations.

[0059] Fig.12 An FPC 900 similar to the FPC shown in the previous figures is shown. The FPC 900 may include a zigzag shaped flexible portion 935 having one trace or electrode located on each side of the FPC 900 and connected to a corresponding snap connector. The snap connector is located in the center of the annular ring 965 and can be connected to the annular ring 965 by soldering the upper half of the annular ring 965 where the copper is not covered by the cover layer, which allows the snap connector to have more movement, reducing trace fatigue. In addition to soldering, the snap connector and the annular ring 965 can be connected in any suitable manner.

[0060] As shown, the flexible portion 935 of the meander shape extends from the FPC 900 and includes a U-shaped portion 945 closest to the main body of the FPC 900, which continues to a straight portion 955 and terminates at an annular ring 965. The annular ring 965 is connected to a corresponding snap connector during adapter assembly. As shown, there is a gap 975 between the flexible portion 935 and the main body of the FPC 900. The gap 975 allows the annular ring 965 to move in three dimensions relative to the main body of the FPC 900. This allows the flexible portion 935 to absorb mechanical stress without damage to the trace caused by any movement of the annular ring 965. The meander shape feature can not only increase the compliance of the FPC 900 to move up and down quickly along the Z axis, but also increase the compliance of the FPC 900 to move along the X and Y axes in a plane perpendicular to the Z axis. In addition, the meander shape feature allows rotation around the X, Y and Z directions. This meandering shape also allows the clip to be displaced without generating high stress in the FPC. Thus, the meandering trace can prevent the breakage of the FPC.

[0061] Fig.13 FIG. 1 shows an FPC 1000 including an inverted T-shaped flexible portion 1035. Fig.13 In the plan view of FIG. 1 , the inverted T-shaped flexible portion 1035 includes a horizontal portion 1045 that is separated from the main body of the FPC 1000. The T-shaped flexible portion 1035 also includes a vertical portion 1055 that is separated from the main body of the FPC 1000, the vertical portion 1055 extending approximately from the center of the horizontal portion 1045 and terminating in an annular ring 1065. The annular ring 1065 is connected to a corresponding snap connector during adapter assembly. As shown, there are two gaps 1075 and 1085 between the flexible portion 1035 and the main body of the FPC 1000. These gaps 1075, 1085 allow the annular ring 1065 to move in three dimensions relative to the main body of the FPC 1000 and rotate in three dimensions around the main body of the FPC 1000. This allows the flexible portion 1035 to absorb mechanical stress without damage to the traces caused by any movement of the annular ring 1065.

[0062] Fig.14 An FPC 1100 including a ring terminal flexible portion 1135 is shown. Fig.14In the plan view of FIG. 1 , the ring terminal flexible portion 1135 includes a vertical portion 1145 separated from the main body of the FPC 1100, which terminates in an annular ring 1165. The annular ring 1165 is connected to a corresponding snap connector during assembly of the adapter. As shown, there is a gap 1175 between the flexible portion 1135 and the main body of the FPC 1100. The gap 1175 allows the annular ring 1165 to move in three dimensions relative to the main body of the FPC 1100 and rotate in three dimensions around the main body of the FPC 1100. This also allows the flexible portion 1135 to absorb mechanical stress without damage to the trace caused by any movement of the annular ring 1165.

[0063] In the modification of the flexible portion of the ring terminal, Fig.15 An FPC 1200 is shown including a spiral shaped flexible portion 1235. The spiral shape resembles a question mark (or an inverted question mark) in which the annular loop is not fully defined. Fig.15 In the plan view of FIG. 1 , the spiral flexible portion 1235 includes a vertical portion 1245 separated from the main body of the FPC 1200, which terminates in a spiral portion 1265. The spiral portion 1265 is connected to a corresponding snap connector during assembly of the adapter. As shown, there is a gap 1275 between the flexible portion 1235 and the main body of the FPC 1200. The spiral portion can be welded to the snap connector only at the tip of the spiral, which allows the snap connector to move. The gap 1275 allows the spiral portion 1265 to move in three dimensions relative to the main body of the FPC 1200 and rotate in three dimensions around the main body of the FPC 1200. This also allows the flexible portion 1235 to absorb mechanical stress without damage to the trace caused by any movement of the spiral portion 1265.

[0064] Optionally, Figure 12 to Figure 14 Any of the flexible portions shown in the flexible circuit of can terminate in a spiral portion rather than an annular ring.

[0065] Fig.16 Discrete wires 1335 are shown that can be used in place of the flexible portion in FPC 1300. Discrete wires 1335 can be soldered to FPC 1300 or can be connected to FPC 1300 through connector 1339. Discrete wires 1335 can be soldered to snap connector 1320. Alternatively, discrete wires 1335 can be connected to FPC 1300 and snap connector 1320 is any suitable method. Fig.16 As shown, FPC 1300 can completely surround snap-on connector 1320. Fig.16As shown by the dashed lines in FIG. 1 , the discrete wires 1335 can be attached to the snap connector 1320 at a first side of the FPC 1300, can extend under the FPC 1300 to a second side of the FPC 1300 opposite the first side, and can then extend back to the first side where the discrete wires 1335 are attached to the first side of the FPC 1300. This arrangement of the discrete wires 1335 can prevent the discrete wires 1335 from being pinched between the snap connector 1320 and the top housing when the snap connector 1320 moves upward due to patient movement or due to snapping and unsnapping of the mating connector and the snap connector 1320.

[0066] Instead of allowing movement in three dimensions, the flexible portion may allow movement in only two dimensions.

[0067] It should be understood that the above description is only an illustration of the present invention. Those skilled in the art may conceive of various alternatives and modifications without departing from the present invention. Therefore, the present invention is intended to cover all such alternatives, modifications and variations that fall within the scope of the appended claims.

Claims

1. An adapter for a patient monitoring device, comprising: a flexible printed circuit located within the adapter and comprising: a rigid portion including a rigid reinforcement; and a flexible portion, the flexible portion including traces, extending from the rigid portion, and movable in two or three dimensions relative to the rigid portion; A connector is disposed on the tip of the flexible portion and connected to one end of the trace, the connector being movable in two or three dimensions independently of the rigid portion and being connectable to an electrode assembly of the patient monitoring device.

2. The adapter according to claim 1, wherein: The rigid reinforcement overlaps the electronic components on the flexible printed circuit.

3. The adapter according to claim 1, wherein: The flexible portion extends from the rigid portion and has a meandering shape.

4. The adapter according to claim 2 or 3, wherein: The flexible portion extends from the rigid portion, wherein a gap is provided between the flexible portion and the rigid portion.

5. The adapter according to claim 1, wherein: The flexible portion extends from the rigid portion in a straight portion.

6. The adapter according to claim 1, wherein: The flexible portion extends from the rigid portion in a straight portion and terminates in a helical portion.

7. The adapter according to claim 1, wherein: The flexible printed circuit includes an additional rigid portion including an additional rigid reinforcement.

8. The adapter according to claim 7, wherein: The patient monitoring device comprises: a sensor assembly connectable to and disconnectable from the adapter; a rigid circuit board connected to the additional rigid portion; and a sensor connector connected to the rigid circuit board; and The sensor connector is connectable to and disconnectable from the sensor assembly.

9. The adapter according to claim 1, wherein: The patient monitoring device includes the electrode assembly, and The electrode assembly is attachable to a patient.

10. The adapter according to claim 1, wherein: The connector may be rotatable in two or three dimensions independently of the rigid portion.

11. The adapter according to claim 1, wherein: The patient monitoring device includes a sensor assembly that is connectable to and disconnectable from the adapter.

12. The adapter according to claim 11, wherein: The sensor assembly includes a gripper that facilitates gripping of an electronic assembly during connection and disconnection of the sensor assembly to the adapter.

13. The adapter according to claim 11, wherein: The adapter and the sensor assembly each include a push tab that facilitates connecting or disconnecting the adapter and the sensor assembly.

14. The adapter according to claim 13, wherein: The push piece of the sensor assembly is laterally offset relative to the push piece of the adapter.

15. An adapter for a patient monitoring device, comprising: a flexible printed circuit located within the adapter and including a rigid portion including a rigid reinforcement member; a connector capable of connecting to the electrode assembly; as well as Discrete wires, the discrete wires connecting the flexible printed circuit and the connector; wherein, The connector may be movable in two or three dimensions independently of the rigid portion.

16. The adapter according to claim 15, wherein: The patient monitoring device includes the electrode assembly, and The electrode assembly is attachable to a patient.

17. The adapter according to claim 15, wherein: The connector may be rotatable in two or three dimensions independently of the rigid portion.

18. An adapter for a patient monitoring device, comprising: a flexible printed circuit located within the adapter and comprising: a rigid portion including a rigid reinforcement; and a flexible portion, the flexible portion including traces extending from the rigid portion, wherein There is a gap between the flexible portion and the rigid portion, and the flexible portion is movable in two or three dimensions relative to the rigid portion; and A connector is disposed on the tip of the flexible portion, connected to one end of the trace, and is connectable to an electrode assembly of the patient monitoring device.

19. The adapter according to one of claims 1, 15 and 18, wherein The adapter includes a first push piece, and The patient monitoring device comprises a sensor assembly connected to the adapter and comprising a second push piece, wherein The adapter and the sensor assembly are separated by applying forces to the first push piece and the second push piece in opposite directions.

20. The adapter of claim 19, wherein: The first push tab and the second push tab are laterally offset from each other.

21. The adapter according to claim 20, wherein: The first push tab and the second push tab are laterally offset from each other such that a user's left thumb and left index finger can be used to separate the adapter and the sensor assembly.

22. The adapter of claim 19, wherein: One of the adapter and the sensor assembly includes an arm, and the other of the sensor assembly and the adapter includes a ledge engageable with the arm.

23. The adapter of claim 22, wherein: Each of the arms includes a slot that receives a corresponding ledge.

24. The adapter of claim 19, wherein: The sensor assembly includes a gripper to facilitate grasping of the sensor assembly.

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