PATIENT-WORN SENSOR INCLUDING COMPLIANT FLEXIBLE PRINTED CIRCUIT ASSEMBLY
20220192599 · 2022-06-23
Inventors
- Michael MARSHIK (Woodbury, MN, US)
- Brandon LA PLANTE (Woodbury, MN, US)
- Dattatraya BATHE (Woodbury, MN, US)
- Scott Mazar (Woodbury, MN, US)
- Nobuhiro KONDO (Woodbury, MN, US)
- Atsuhiko HIRATA (Woodbury, MN, US)
Cpc classification
A61B5/6801
HUMAN NECESSITIES
A61B2562/164
HUMAN NECESSITIES
International classification
Abstract
A patient-monitoring device includes an adapter with a flexible printed circuit, the flexible printed circuit includes a rigid portion with a rigid stiffener and a flexible portion with a trace, and with a connector that is connected to one end of the trace, that is movable in two or three dimensions independent of the rigid portion, and that is connectible to an electrode assembly.
Claims
1. : A patient-monitoring device comprising: an adapter including: a flexible printed circuit including: a rigid portion that includes a rigid stiffener; and a flexible portion that includes a trace; and a connector that is connected to one end of the trace, that is movable in two or three dimensions independent of the rigid portion, and that is connectible to an electrode assembly.
2. : The patient-monitoring device of claim 1, wherein the rigid stiffener overlaps with electronic components on the flexible printed circuit.
3. : The patient-monitoring device of claim 1, wherein the flexible portion extends from the rigid portion and has a meander shape.
4. : The patient-monitoring device of claim 1, wherein the flexible portion extends from the rigid portion with a gap between the flexible portion and the rigid portion.
5. : The patient-monitoring device of claim 1, wherein the flexible portion extends with a straight portion from the rigid portion.
6. : The patient-monitoring device of claim 1, wherein the flexible portion extends with a straight portion from the rigid portion, and is terminated in a spiral portion.
7. : The patient-monitoring device of claim 1, wherein the flexible printed circuit includes an additional rigid portion that includes an additional rigid stiffener.
8. : The patient-monitoring device of claim 7, further comprising: a sensor assembly that is connectible to and disconnectible 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 is connectible to and disconnectible from the sensor assembly.
9. : The patient-monitoring device of claim 1, further comprising the electrode assembly; wherein the electrode assembly is attachable to a patient.
10. : The patient-monitoring device of claim 1, wherein the connector is rotatable in two or three dimensions independent of the rigid portion.
11. : The patient-monitoring device of claim 1, further comprising a sensor assembly that is connectible to and disconnectible from the adapter.
12. : The patient-monitoring device of claim 11, wherein the sensor assembly includes a grip to assist in gripping an electronics assembly during connection and disconnection of the sensor assembly from the adapter.
13. : The patient-monitoring device of claim 11, wherein the adapter and the sensor assembly both include a push tab to assist connecting or disconnecting the adapter and the sensor assembly.
14. : The patient-monitoring device of claim 13, wherein the push tab of the sensor assembly is laterally offset relative to the push tab of the adapter.
15. : A patient-monitoring device comprising: an adapter that includes a first push tab; and a sensor assembly that is connected to the adapter and that includes a second push tab; wherein the adapter and the sensor assembly are separated by applying forces to the first and second push tabs in opposite directions.
16. : The patient-monitoring device of claim 15, wherein the first and second push tabs are laterally offset from each other.
17. : The patient-monitoring device of claim 16, wherein the first and second push tabs 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.
18. : The patient-monitoring device of claim 15, wherein one of the adapter and the sensor assembly includes arms, and the other of the sensor assembly and the adapter includes ledges that are engageable with the arms.
19. : The patient-monitoring device of claim 18, wherein each of the arms includes a slot that receives a corresponding ledge.
20. : The patient-monitoring device of claim 15, wherein the sensor assembly includes a grip to assist in gripping the sensor assembly.
21. : A patient-monitoring device comprising: an adapter including: a flexible printed circuit that includes a rigid portion that includes a rigid stiffener; a connector that is connectible to an electrode assembly; and a discrete wire that connects the flexible printed circuit and the connector; wherein the connector is movable in two or three dimensions independent of the rigid portion.
22. : The patient-monitoring device of claim 21, further comprising the electrode assembly; wherein the electrode assembly is attachable to a patient.
23. : The patient-monitoring device of claim 21, wherein the connector is rotatable in two or three dimensions independent of the rigid portion.
24. : A patient-monitoring device comprising: an adapter including: a flexible printed circuit including: a rigid portion that includes a rigid stiffener; and a flexible portion that includes a trace and that extends from the rigid portion with a gap between the flexible portion and the rigid portion; and a connector that is connected to one end of the trace and connectable to an electrode assembly.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0030]
[0031] The patient-worn sensor 102 can also communicate with one or more other computing devices, either through wired or wireless communication. For example, the patient-worn sensor 102 can use Bluetooth, WiFi, or a cellular communication protocol to communicate with other computing devices such as bedside monitors, personal computers, tablet devices, mobile phones, central servers, or a cloud-based network. As an example, the patient-worn sensor 102 can transmit vital-sign information collected from the patient 104 to a tablet device or personal computer functioning as a bedside monitor. The tablet or personal computer can process received information and display the information in a readably understandable format to a caretaker or other user. For example, a tablet device can receive vital-sign information from the patient-worn sensor 102 through a Bluetooth connection and display an electrocardiogram (ECG) waveform of the patient as well as information on the patient's heart rate, respiration rate, blood oxygenation level, body temperature, and/or other vital signs. As another example, the patient-worn sensor 102 can be periodically connected to a computing device (such as a bedside monitor) through 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., personal computers, servers located at the hospital, cloud storage servers, etc.).
[0032] Furthermore, information recorded by the patient-worn sensor 102 can be transmitted to other computing devices for use in both real-time or near real-time analysis of the patient 104's condition as well as for tracking of vital-sign information for the patient 104 over time. For example, the information recorded by the patient-worn sensor 102 can be transmitted to a display device to allow caregivers to observe the information and make adjustments to patient care for the patient 104 based on the information. The information can also be transmitted to a central information repository to allow historical vital-sign and other information for the patient to be logged. Both real-time and historical vital-sign information, and other information, for a patient can be accessed by caregivers who are not at the same physical location as the patient. For example, vital-sign information collected by the patient-worn sensor 102 can be transmitted to a mobile device owned by the patient 104 (e.g., a smart phone) to allow the patient 104 to view the information. The information can further be transmitted to a central server that can be accessed by one or more caregivers (e.g., using personal computers or mobile devices) to allow the caregivers to view the collected information and make patient care decisions for the patient 104 from a location that is remote from where the patient 104 is located.
[0033] Other components that can be included as part of the patient-worn sensor 102 include a power supply, buttons, or other input mechanisms for receiving user input, one or more audible alarms or speakers, and lights or a display screen. A power supply for the patient-worn sensor 102 can be a battery pack that receives standard disposable batteries, a rechargeable battery, or a removable battery pack that can be replaced with a fully charged battery pack. The patient-worn sensor 102 can further include input mechanisms such as, for example, buttons, keys, or a touch screen. The input mechanisms can allow the patient 104 or a caregiver to adjust settings for the patient-worn sensor 102, perform various tests (such as sensor tests, battery power level tests, etc.) or reset one or more alarms for the patient-worn sensor 102. The input mechanisms can also allow the patient 104 to place a distress call (e.g., to a caregiver or to a hospital alert system) if the patient 104 is in need of assistance.
[0034]
[0035]
[0036] As shown in
[0037]
[0038] Additionally,
[0039]
[0040] In addition,
[0041]
[0042] When a user tries to remove a sensor from an adapter, he or she can put fingers, including thumbs, on the push tabs and push them in opposite directions to easily disengage the sensor. More particularly, a user can put a left thumb on the bottom side of the push tab of the sensor and a left index finger on the top side of push tab of the adapter while holding the sensor grips with a right thumb and a right index finger. Then, by a twisting motion of the left finger and thumb, the push tabs are pushed away from each other so that the sensor is removed from the adapter in a safe manner. To encourage users to grip the sensor with the right hand while handling the push tabs with the left hand, the push tab on the sensor can be located to the left of the push tab on the adapter. Assuming the patient-worn sensor is in contact with the left side of a patient's chest, as is often the case, removing the sensor with the user's right hand makes it less likely the user will hit the patient's face when removing the sensor than if the user's left hand is used.
[0043] The rear perspective view of
[0044] The stabilizing boots 550 can absorb shock caused by movement of the patient while still allowing for a degree of compliance in the X, Y, and Z directions and in rotations about the X, Y, and Z directions. The stabilizing boots 550 can provide stability to a connection between the patient-worn sensor, the snap connector 555, and an adhesive pad connected to a patient by providing for a greater degree of movement in a Z-axis direction than in X-axis and Y-axis directions of the patient-worn sensor relative to the patient. The Z-axis can be, for example, a direction that is substantially perpendicular to the patient's skin (and therefore the contact surface of the adhesive electrode pad) while the X-axis and Y-axis directions are substantially parallel to the patient's skin (and therefore the contact surface of the adhesive electrode pad). When in use, an adhesive side of the adhesive electrode pad portion of the patient-worn sensor is affixed to a patient while the opposite side of the adhesive electrode pad is attached to the patient-worn sensor by way of disposable snap connectors of electrodes of the adhesive electrode pad engaging the electrical contacts 555. Once the patient-worn sensor is attached to the patient, the patient is free to move, which can cause shifting in the relative location of contact points on the patient's skin at which the electrodes of the adhesive electrode pad contact the patient. The stabilizing boots 550 can absorb some or all of the motion caused by movement of the patient, thereby reducing negative effects on signal integrity and quality received by the electrodes of the adhesive electrode pad. In some implementations, the stabilizing boots 550 extend beyond the electrical contacts 555 to at least partially encircle portions of the electrodes of the adhesive electrode pad.
[0045] The stabilizing boots 550 can be made using an over-molding process, such that the stabilizing boots 550 are integrated with a portion of a housing of the adapter 500 as an integral piece. The over-molding process allows for the stabilizing boots 550 to be made from a material having less rigidity than a material used to form other portions of the adapter housing, while still allowing the stabilizing boots 550 to be defined as an integral piece with at least a portion of the adapter housing. For example, the stabilizing boots 550 can be defined from a thermoplastic elastomer (TPE) material using the over-molding process.
[0046]
[0047] The top housing and the bottom housing 610 can be made from molded plastic or another material that is suitably light weight so as to facilitate easy attachment to a patient and a sensor, while also structurally strong enough to protect the inner components of the adapter 600 from damage if the adapter 600 or patient-worn sensor is dropped. The top housing and the bottom housing 610 can, for example, be plastic injection molded parts molded from a high impact plastic such as polycarbonate (PC), acrylonitrile butadiene styrene (ABS) or an ABS/PC blend. The top housing and the bottom housing 610 can also engage with each other in a water-tight or semi-water-tight seal to prevent moisture from reaching the inner components of the adapter 600.
[0048] As shown in
[0049] The FPC 630 can include a rigid portion with various processing components implemented as integrated circuit chips and/or other electrical components (not shown). Thus, the FPC 630 can be made from polyimide, or any other suitable material. The FPC 630 can include passive components, such as resistors, and can transmit signals. The FPC 630 can also include active components, such as one or more processors, that can process signals received from a patient, and can include one or more communications modules to communicate with other computing devices using one or more communications protocols (e.g., Bluetooth, WiFi, cellular communication, etc.). Other components that can be included in the circuitry of the FPC 630 are interface circuits to interface with an electronic device, such as a sensor, one or more accelerometers, a GPS or other location detection circuit, temperature sensors to sense environmental temperature, light sensors to sense environmental light, and output circuits to output information to a user through the control of output devices such as lights, speakers, audible alarms, display screens, etc.
[0050] The FPC 630 can further include flexible portions 635 that are aligned with each of the snap connectors 620. The flexible portions 635 includes traces that are 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 flexible portions 635, it is possible to use discrete wires to connect the FPC 630 to the snap connectors 620.
[0051] Rather than bending a portion of the FPC 630, for example, by 180°, to allow the FPC 630 to be connected with the sensor, the FPC 630 can use the connector board 640 and connector 650. The connector board 640 can be electrically connected to the FPC 630 directly by soldering, by discrete wiring, or via an additional stacking connector. The connector board 640 is preferably a rigid printed circuit board (PCB) but can be a flexible circuit board or any other suitable substrate.
[0052] The flexible portions 635 are used to absorb movement of the snap connectors 620 following any patient skin movement. However, a problem of trace disconnection can occur near mounted electrical components due to high stress concentration that is caused when the FPC 630 is unintentionally bent or mishandled during the assembly process. To prevent the problem of trace fatigue or damage, stiffeners can be added to portions of FPC 630 where electrical components are mounted.
[0053] The left-hand portion of
[0054]
[0055] Another problem can arise by trace fatigue in the FPC caused by forces from the stabilizing boots through the snap connectors during repeated movement of the stabilizing boots by patient skin motion or snapping and unsnapping of the mating snap connectors. Trace fatigue can cause intermittent contact or a complete disconnection of the FPC and associated circuitry with the snap connector, the mating snap connector, and the electrical device such as a sensor. This problem can be eliminated or minimized by using different configurations of trace routing in the FPC.
[0056]
[0057] As shown, the meander shape of a flexible portion 935 extends from the FPC 900 and includes a U-shaped portion 945 closest to the main portion of the FPC 900 that continues to a straight portion 955 and terminates in the 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 portion of the FPC 900. This gap 975 allows the annular ring 965 to move in three dimensions relative to the main portion of the FPC 900. This allows the flexible portions 935 to absorb mechanical stresses without damage to the traces caused by any movement of the annular ring 965. The meander shape feature can increase compliance of the FPC 900, not only in the Z-axis of snap up and down movement, but also for movement in the X- and Y-axes in a plane perpendicular to the Z-axis. In addition, the meander shape feature allows for rotations around the X, Y, and Z directions. This meander shape also allows displacement of snaps without arising high stress in the FPC. Therefore, the meander-shaped trace can prevent fracture of the FPC.
[0058]
[0059]
[0060] In a modification of the ring-terminal flexible portion,
[0061] Optionally, any of the flexible portions shown in the flexible circuits of
[0062]
[0063] Instead of allowing movement in three dimensions, the flexible portion can allow movement in only two dimensions.
[0064] It should be understood that the foregoing description is only illustrative of the present invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the present invention. Accordingly, the present invention is intended to embrace all such alternatives, modifications, and variances that fall within the scope of the appended claims.