Device and method for detecting signals from the body

Abstract

The kit for transmitting and sensing signals includes a multi-connection cable having multiple cable connectors at a distal end of the cable for establishing electrical communication between each of the cable connectors and a system for measuring bioimpedance connectable to a proximal end of the cable, and multiple devices for transmitting and sensing signals. Each device includes a non-conductive substrate adhereable to the subject's skin, first and second electrical contacts printed on the substrate, and a disposable connector. Each disposable connector is connectable to a compatible cable connector on the cable such that the combined thickness of the disposable connector and the compatible cable connector is less than 4 mm after connection.

Description

[Technical field]

[0001] The present invention, in some embodiments thereof, relates to medical devices, and more particularly to devices and methods for sensing signals, such as, but not limited to, radio frequency signals, from the body.

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 869,066, filed July 1, 2019, the contents of which are incorporated by reference as if fully set forth herein. [Background technology]

[0003] Techniques for measuring electrical properties of organs are generally known, such as measuring bioimpedance. Various methods using bioimpedance can be found in WO 2004 / 098376, WO 2006 / 087696, WO 2008 / 102362, WO 2009 / 022330 and WO 2010 / 032252, WO 2013 / 014671, the contents of which are incorporated herein by reference.

[0004] For example, the '696 application discloses transmitting an output radio frequency signal to an organ of a subject, receiving an input radio frequency signal from the organ, determining a phase shift of the input signal relative to the output signal, and using the phase shift to calculate the cardiac output of the subject.

[0005] The '362 application describes a sticker for transmitting and detecting radio frequency signals. The electrical contacts are fixed with a distance between them to reduce the effect of the variable interelectrode distance on the measurement. The sticker is connected to a monitoring system via a connector having conductive members, with each electrical contact in electrical communication with one conductive member via a different conductive line. Summary of the Invention

[0006] According to an aspect of some embodiments of the present invention, there is provided a device for transmitting and sensing signals, the device comprising a non-conductive substrate adhereable to a subject's skin, first and second electrical contacts printed on the substrate, and a disposable connector connectable to a compatible cable connector of a cable receiving signals from the contacts via the disposable connector for transmitting the signals to a signal processing device of a system for measuring bioimpedance. The disposable connector has a symmetrical shape such that mating between the disposable connector and the compatible cable connector can be established in either of two inverted orientations.

[0007] According to some embodiments of the invention, the device is packaged with a label indicating that the device is for attachment to each of a number of different locations on the subject's body.

[0008] According to some embodiments of the invention, the plurality of different locations includes upper left abdominal region, right upper abdominal region, lower left abdominal region, lower right abdominal region, upper left back region, upper right back region, lower left back region, and lower right back region.

[0009] According to some embodiments of the invention, the length of the device from the contacts to the single-use connector is less than 25 cm.

[0010] According to some embodiments of the present invention, the single-use connector is attached to an integral extension of the non-conductive substrate such that the single-use connector and the non-conductive substrate are parallel to one another.

[0011] According to some embodiments of the invention, the device comprises an authentication tag attached to, printed on, or integrated with the single-use connector, the authentication tag configured to authenticate the device, and a combined thickness of the single-use connector and the authentication tag is less than 4 mm.

[0012] According to some embodiments of the present invention, the authentication tag comprises an electronic chip having an internal clock or counter and is configured to generate an alarm signal in response to the state of the internal clock or counter and to transmit the alarm signal via a cable to the system.

[0013] According to an aspect of some embodiments of the present invention there is provided a kit comprising a plurality of devices for transmitting and detecting signals, all of which are identical in appearance and structure, each device being as described above, and optionally, preferably as further exemplified below.

[0014] According to an aspect of some embodiments of the present invention there is provided a kit for transmitting and detecting signals. The kit includes a plurality of devices for transmitting and detecting signals, each device as described above and optionally, preferably as further exemplified below. The kit also includes a multi-connection cable having a respective plurality of cable connectors at a distal end of the cable, each cable connector being compatible with a single-use connector of one of the devices.

[0015] According to some embodiments of the present invention for each pair of single-use connectors and cable connectors of the kit, at least one of the single-use connector and the cable connector includes markings indicating a connection orientation depending on the body part of the subject to which the device is attached.

[0016] According to some embodiments of the invention, all of the devices in the kit are identical in appearance and construction.

[0017] According to some embodiments of the present invention, the single-use connector is attached to an integral extension of the non-conductive substrate such that the single-use connector, the non-conductive substrate, and the cable connector connected to the single-use connector are all parallel to one another.

[0018] According to some embodiments of the invention, there are four devices in the kit.

[0019] According to an aspect of some embodiments of the present invention there is provided a method of transmitting and sensing signals, the method comprising attaching a plurality of devices for transmitting and sensing signals to a body of a subject, each device being as described above and optionally, preferably as further exemplified below, and connecting a multi-connection cable between the plurality of devices and a connector panel of a bioimpedance measurement system.

[0020] According to an aspect of some embodiments of the invention, there is provided a kit for transmitting and sensing signals, the kit comprising: a multi-connection cable having a plurality of cable connectors at a distal end of the cable for establishing electrical communication between each of the plurality of cable connectors and a signal processor of a system for measuring bioimpedance connectable to a proximal end of the cable; and a plurality of devices for transmitting and sensing signals, each device comprising a non-conductive substrate adhereable to a subject's skin, first and second electrical contacts printed on the substrate, and a disposable connector. According to some embodiments of the invention, each disposable connector is connectable to a compatible cable connector of the cable such that the combined thickness of the single-use connector and the compatible cable connector after being connected is less than 4 mm.

[0021] According to some embodiments of the invention, the single-use connectors of the kit are orientation specific such that mating between the single-use connector and a compatible cable connector is only established in one orientation and not in an inverted orientation. According to some embodiments of the invention, each of the devices of the kit is provided with markings or is packaged in a separate package with markings indicating the body part of the subject to which the device is to be attached. According to some embodiments of the invention, each cable connector is provided with markings indicating the device to be connected to the cable connector by the respective single-use connector.

[0022] According to some embodiments of the invention, the single-use connector has a symmetrical shape such that the engagement between the single-use connector and the cable connector can be established in either of two inverted orientations. According to some embodiments of the invention, one of the devices of the kit is packaged with a label indicating that at least one device is for attachment to each of a plurality of different locations on the subject's body, optionally, preferably, the upper half of the subject's body. According to some embodiments of the invention, the plurality of different locations include the left upper abdominal region, the right upper abdominal region, the left lower abdominal region, the right lower abdominal region, the left upper back region, the right upper back region, the left lower back region, and the right lower back region. According to some embodiments of the invention for each pair of single-use connector and cable connector, at least one of the single-use connector and the cable connector includes a marking indicating a connection orientation according to the part of the subject's body to which the device is attached. According to some embodiments of the invention, all of the devices are identical in appearance and structure. According to some embodiments of the invention, there are four devices.

[0023] According to some embodiments of the invention, the length of each device in the kit, from the contacts to the single-use connector, is less than 25 cm.

[0024] According to some embodiments of the invention, each device in the kit includes printed conductive traces leading from the contacts to a disposable connector.

[0025] According to some embodiments of the present invention, a single-use connector includes a first conductive wire connected to a first electrical contact, a second conductive wire connected to a second electrical contact, and at least one floating conductive wire between the first and second conductive wires.

[0026] According to some embodiments of the present invention, the conductive lines are printed conductive lines.

[0027] According to some embodiments of the present invention, the conductive lines and the printed electrical contacts mate flush.

[0028] According to some embodiments of the present invention, the single-use connector is attached to an integral extension of the non-conductive substrate such that the single-use connector, the non-conductive substrate, and the cable connector after being connected to the single-use connector are all parallel to one another.

[0029] According to some embodiments of the present invention, the single-use connector includes an authentication tag for authenticating the respective device, and a thickness of less than 4 mm encompasses the single-use connector, the authentication tag and the cable connector.

[0030] According to some embodiments of the present invention, the authentication tag comprises an electronic chip having an internal clock or counter and is configured to generate an alarm signal in response to the state of the internal clock or counter and to transmit the alarm signal via a cable to the bioimpedance measurement system.

[0031] According to some embodiments of the present invention, a multi-connection cable includes separate electrical shields for wires conducting transmit signals and wires conducting receive signals.

[0032] According to an aspect of some embodiments of the present invention there is provided a method of transmitting and sensing signals, the method comprising providing a kit as described above and optionally, preferably, further exemplified below, attaching a plurality of devices to a subject's skin at a plurality of different respective locations, and connecting a multi-connection cable between the plurality of devices and a connector panel of a system for measuring bioimpedance.

[0033] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of this invention, exemplary methods and / or materials are described below. In case of conflict, this patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0034] Implementation of the method and / or system of embodiments of the present invention may involve performing or completing selected tasks manually, automatically, or a combination thereof. Further, depending on the actual instrumentation and equipment of the embodiments of the method and / or system of the present invention, some selected tasks may be performed by hardware, software, or firmware, or a combination thereof using an operating system.

[0035] For example, hardware for performing selected tasks according to embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to embodiments of the present invention may be implemented as a number of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a number of instructions. Optionally, the data processor comprises a volatile memory for storing instructions and / or data, and / or a non-volatile storage, e.g., a magnetic hard disk and / or a removable media, for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device, e.g., a keyboard or mouse, are also optionally provided.

[0036] (Item 1) 1. A kit for transmitting and detecting a signal, said kit comprising: a multi-connection cable having a plurality of cable connectors at a distal end of the cable for establishing electrical communication between each of the cable connectors and a system for measuring bioimpedance connectable to a proximal end of the cable; a plurality of devices for transmitting and sensing signals, each device comprising a non-conductive substrate adhereable to the subject's skin, first and second electrical contacts printed on the substrate, and a disposable connector; Equipped with A kit, wherein each single-use connector is connectable to the compatible cable connector of the cable such that the combined thickness of the single-use connector and the compatible cable connector once connected is less than 4 mm. (Item 2) 2. The kit of item 1, wherein the length of each device from the contacts to the single-use connector is less than 25 cm. (Item 3) 3. The kit of item 2, wherein each device includes printed conductive lines leading from the contacts to the single-use connector. (Item 4) 2. The kit of claim 1, wherein the single-use connector comprises a first conductive wire connected to the first electrical contact, a second conductive wire connected to the second electrical contact, and at least one floating conductive wire between the first conductive wire and the second conductive wire. (Item 5) 5. The kit of claim 4, wherein the conductive lines are printed conductive lines. (Item 6) 4. The kit of claim 3, wherein the conductive lines and the printed electrical contacts are in flush engagement. (Item 7) Item 1. The kit of item 1, wherein the single-use connector is attached to an integral extension of the non-conductive substrate such that the single-use connector, the non-conductive substrate, and the cable connector are parallel to one another after being connected to the single-use connector. (Item 8) 2. The kit of claim 1, wherein the single-use connector comprises an authentication tag for authenticating each of the devices, and the thickness of less than 4 mm includes the single-use connector, the authentication tag, and the cable connector. (Item 9) 9. The kit of claim 8, wherein the authentication tag comprises an electronic chip having an internal clock or counter, and is configured to generate an alert signal in response to a state of the internal clock or counter, and to transmit the alert signal to the system via the cable. (Item 10) 10. The kit of claim 9, wherein the authentication tag comprises an electronic chip having an internal clock or counter, and is configured to generate an alert signal in response to a state of the internal clock or counter, and to transmit the alert signal to the system via the cable. (Item 11) 2. The kit of claim 1, wherein the single-use connector is orientation specific such that mating between the single-use connector and the compatible cable connector is established only in one orientation and not in an inverted orientation. (Item 12) Item 12. The kit of item 11, wherein each of the plurality of devices comprises a marking or is packaged in a separate package comprising a marking indicating a body part of the subject to which the plurality of devices is attached. (Item 13) Item 13. The kit of item 12, wherein each of the plurality of devices comprises a marking or is packaged in a separate package comprising a marking indicating a body part of the subject to which the device is to be attached. (Item 14) Item 14. The kit of item 13, wherein each cable connector includes markings indicating a device to be connected to the cable connector by the respective disposable connector. (Item 15) Item 15. The kit of item 14, wherein each cable connector includes markings indicating a device to be connected to the cable connector by the respective disposable connector. (Item 16) Item 1, the kit of claim 1, wherein the single-use connector has a symmetrical shape such that engagement between the single-use connector and the cable connector can be established in either of two inverted orientations. (Item 17) 17. The kit of item 16, wherein at least one of the plurality of devices is packaged with a label indicating that the at least one device is for attachment to each of eight different locations on the upper body of a subject. (Item 18) 20. The kit of item 17, wherein at least one of the plurality of devices is packaged with a label indicating that the at least one device is for attachment to each of eight different locations on the upper body of a subject. (Item 19) Item 19. The kit of item 18, wherein the eight different locations include the left upper abdominal region, the right upper abdominal region, the left lower abdominal region, the right lower abdominal region, the left upper dorsal region, the right upper dorsal region, the left lower dorsal region, and the right lower dorsal region. (Item 20) 1. A method for transmitting and detecting a signal, comprising: a multi-connection cable having a plurality of cable connectors at a distal end of the cable for establishing electrical communication between each of the cable connectors and a system for measuring bioimpedance connectable to a proximal end of the cable; providing a kit including a plurality of devices for transmitting and sensing signals, each device comprising a non-conductive substrate adhereable to a subject's skin, first and second electrical contacts printed on the substrate, and a disposable connector; each single-use connector is connectable to a compatible cable connector of the cable such that a combined thickness of the single-use connector and the compatible cable connector after connection is less than 4 mm; attaching said plurality of devices to a subject's skin at a respective plurality of different locations; connecting the multi-connection cable between the plurality of devices and a connector panel of a bioimpedance measurement system; The method includes: Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings. Referring now in detail to the drawings, it is stressed that the particulars shown are by way of example and for illustrative discussion of embodiments of the invention. In this regard, the description given with respect to the drawings will make apparent to those skilled in the art how to practice embodiments of the invention. [Brief description of the drawings]

[0037] [Figure 1A] FIG. 1 is a schematic diagram illustrating a perspective view of a device for transmitting and sensing signals according to some embodiments of the present invention. [Figure 1B] FIG. 2 is a schematic diagram illustrating a front view of a device for transmitting and sensing signals according to some embodiments of the present invention. [Figure 1C] FIG. 2 is a schematic diagram illustrating a rear view of a device for transmitting and sensing signals according to some embodiments of the present invention. [Figure 2A] FIG. 1 is a schematic diagram illustrating an exploded view of a device for transmitting and sensing signals according to some embodiments of the present invention. [Figure 2B] 11 is an image showing bending of conductive lines in a connection member according to some embodiments of the present invention. [Figure 3A] 1 is a schematic diagram illustrating a connection between a connector and a cable by a cable connector according to some embodiments of the present invention. [Figure 3B]1 is a schematic diagram illustrating a connection between a connector and a cable by a cable connector according to some embodiments of the present invention. [Figure 4A] 1 is a schematic diagram of a multi-connection cable in an embodiment in which the cable includes four cable connectors. [Figure 4B] 1 is a schematic diagram of a multi-connection cable in an embodiment in which the cable includes four cable connectors. [Figure 5A] FIG. 13 is a schematic diagram of the distal end of a cable in an embodiment in which each of the cable connectors has markings indicating different body parts of the subject. [Figure 5B] FIG. 1 illustrates the packaging of devices with markings that allow the practitioner to place each device in its proper location and connect it to the appropriate distal cable connector. [Figure 5C] FIG. 1 illustrates the packaging of devices with markings that allow the practitioner to place each device in its proper location and connect it to the appropriate distal cable connector. [Figure 5D] FIG. 1 illustrates the packaging of devices with markings that allow the practitioner to place each device in its proper location and connect it to the appropriate distal cable connector. [Figure 5E] FIG. 1 illustrates the packaging of devices with markings that allow the practitioner to place each device in its proper location and connect it to the appropriate distal cable connector. [Figure 6A] 1 is a schematic diagram of a label indicating eight different positions on a subject's body, according to various exemplary embodiments of the present invention. [Figure 6B] 1A-1C are schematic diagrams illustrating eight possible markings that may be provided on the front and back sides of a cable connector according to some embodiments of the present invention. [Figure 6C] 1A-1C are schematic diagrams illustrating eight possible markings that may be provided on the front and back sides of a cable connector according to some embodiments of the present invention. [Figure 7]1 is a schematic block diagram illustrating a bioimpedance measurement system, according to some embodiments of the present invention. [Figure 8A] 10A-10C show the results of experiments conducted in accordance with some exemplary embodiments of the present invention to investigate the ability of the devices and cables of the present embodiments to reduce crosstalk and noise. [Figure 8B] 10A-10C show the results of experiments conducted in accordance with some exemplary embodiments of the present invention to investigate the ability of the devices and cables of the present embodiments to reduce crosstalk and noise. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] The present invention, in some embodiments thereof, relates to medical devices, in particular to devices and methods for sensing signals, such as, but not limited to, radio frequency signals from the body.

[0039] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0040] Methods using bioimpedance measurements involve placing multiple electrodes on the patient's skin, typically on the chest. Electrical signals are transmitted and received via the electrodes and changes in the electrical impedance of the subject's tissue over time are measured and correlated with cardiac parameters.

[0041] Due to various anatomical factors, electrodes are typically placed at specific locations on the body to obtain a better correlation between the measured changes in bioimpedance and cardiac parameters. A typical configuration for monitoring electrical properties of a body part is a quadripolar configuration of electrodes attached to the subject's skin at the upper and lower upper regions of the body. Each pair of electrodes is soldered to the distal end of a cable that is connected at its proximal end to a signal processor. The signal processor analyzes and correlates the signals received from the electrodes with cardiac parameters.

[0042] The inventors have found that soldering the cables to the electrodes creates usability problems, for example, the cables can become dislodged from the electrodes during surgery, causing a loss of signal, and in such a situation, attaching a new set of electrodes is often not possible as it would interrupt the procedure.

[0043] The inventors have found that the wires in the cable are somewhat susceptible to external noise signals and also susceptible to crosstalk between the transmitting and receiving electrodes, which the inventors have found results in a noisier signal and makes it difficult to detect when the electrodes are removed from the skin.

[0044] The inventors have also found that bioimpedance measurements can be performed by connecting electrodes to the back region of the subject. However, while reducing such manual connections, the inventors have found that the electrodes can cause discomfort to the subject, especially when the subject is in a supine position, and can also lead to pressure sores or other types of injury.

[0045] In seeking a solution to at least one of the above problems, the inventors have devised a device and kit for transmitting and detecting signals. Referring now to the drawings, FIGS. 1A-1C are perspective (FIG. 1A), front (FIG. 1B), and rear (FIG. 1C) views of a device 10 for transmitting and detecting signals according to some embodiments of the present invention. The device 10 can include a non-conductive substrate 12, two electrical contacts 14 printed on the substrate 12, and a disposable connector 16. The device 10 is preferably disposable in its entirety. The back surface of the substrate 12 is typically adhesive to the skin of a subject. For example, the back surface of the substrate 12 can include an adhesive layer (not shown, see FIGS. 2A-2B) for attaching the back surface of the substrate 12 to the skin of a subject.

[0046] The substrate 12 is optionally, but preferably, multi-layered. Representative examples of suitable multi-layered structures for the substrate 12 are described below with reference to FIGS. 2A-2B. The connector 16 is typically attached to an integral extension 22 of the non-conductive substrate 12 such that the connector 16 and the substrate 12 are parallel to each other. This improves comfort to the subject, especially when the device is between the subject's skin and a bed (e.g., connected to the subject's back region while the subject is supine). This differs from conventional electrodes with connectors protruding from an adhesive substrate. The integral extension 22 is optionally, but preferably, elongated, with a length-to-width aspect ratio of about 3 to about 10.

[0047] In any of the embodiments described herein, the thickness t of connector 16 as measured perpendicular to substrate 12 is preferably less than 4 mm. In experiments conducted by the inventors, it was found that when connector 16 has a thickness of less than 4 mm, it is not noticed by the majority of subjects and does not cause pressure sores or other types of injury, thus significantly improving the comfort of the subjects.

[0048] The contacts 14 are spaced apart from each other. One of the contacts 14 functions to transmit a transmit signal Tx to the subject's body, and the other of the contacts 14 functions to detect a receive signal Rx from the subject's body. A typical distance between the centers of the contacts 14 is about 10 mm to about 70 mm, more preferably about 20 mm to about 70 mm, more preferably about 30 mm to about 70 mm, more preferably about 40 mm to about 70 mm, more preferably about 50 mm to about 70 mm, more preferably about 55 mm to about 65 mm, more preferably about 57 mm to about 62 mm, even more preferably about 57 mm to about 60 mm, or about 58 mm to about 59 mm, for example, about 58.5 mm. The inventors have found that such a range of distances between the entry point of the Tx signal and the exit point of the Rx signal provides substantially better results compared to other distances. The contacts 14 are typically printed on the section 24 of the substrate 12 from which the extension 22 extends, and are typically wider than the extension 22. Typically, but not necessarily, the aspect ratio of length to width of section 24 is about 0.5 to about 1.5. The total length of device 10 from contacts 14 to connector 16 is typically less than 25 cm or less than 20 cm, for example, about 5 cm to about 15 cm. As described below, use of device 10 involves establishing electrical communication between device 10 and a signal processor via a cable, with device 10 connected to a cable connector at the distal end of the cable and the signal processor connected to a cable connector at the proximal end of the cable. Unlike device 10, a cable with connectors at its proximal and distal ends can typically be used multiple times and is therefore not manufactured disposable. Thus, making device 10 sufficiently small (e.g., less than 25 cm or less than 20 cm or less than 15 cm) is advantageous from a cost perspective, since in this case a larger portion of the length of communication between contacts 14 and the signal processor is due to a reusable, non-disposable cable.

[0049] In some embodiments of the invention, the device includes a bolus 32 of gel that covers the contacts 14 on the back side of the device 10. The bolus 32 functions to provide better electrical contact and impedance matching with the subject's skin. The bolus 32 may include any conductive gel, such as but not limited to a conductive hydrogel. In some embodiments of the invention, the back side of the device 10 is at least partially covered by a removable protective film 34 to protect the contacts 14, the bolus 32, and the adhesive layer.

[0050] The device 10 further comprises a pair of conductive lines 18 leading from the contacts 14 to the connector 16. The conductive lines 18 are optionally, but preferably, also printed on the substrate 12. In some embodiments of the invention, the device 10 further comprises one or more floating conductive lines 20 between the conductive lines 18. An advantage of these embodiments is that the floating lines 20 provide electrical shielding between the lines 18. The floating conductive line(s) 20 are also preferably printed on the substrate 12. The conductive lines 18 and 20 (if used) preferably engage the electrical contacts 14 flush.

[0051] In some embodiments of the invention, device 10 includes an authentication tag 30 attached to, printed on, or otherwise integrated with connector 16. Authentication tag 30 is configured to authenticate device 10 when connected to a bioimpedance measurement system. In any embodiment in which tag 30 is used, the combined thickness t of connector 16 and tag 30 is preferably less than 4 mm.

[0052] The authentication tag 30 may be of any machine-readable type known in the art, such as, but not limited to, a barcode, or an electronic chip, e.g., an RFID chip, an EEPROM chip, or an RTLS chip. In some embodiments of the present invention, the electronic chip of the authentication tag 30 comprises an internal clock or counter and is configured to generate an alarm signal in response to the state of the internal clock or counter. For example, the electronic chip can optionally and preferably measure the time elapsed since the first use of the device 10 and generate an alarm signal when the disposable device 10 has been used for a time exceeding a preset time recommended for clinical use (e.g., a preset time such as 30 minutes, or 1 hour, or 2 hours, or 6 hours, or 12 hours, or 24 hours, or 48 hours). In response to the alarm signal, the operator can replace the device. When the authentication tag 30 comprises an electronic chip, the device 10 optionally and preferably comprises a dedicated authentication conductive line 21 for transmitting signals (e.g., authentication signals, clock signals, alarm signals, etc.) to a signal processor. An authentication line 21 is also preferably printed on substrate 12 and preferably engages flush with lines 18 and 20 (if used) and electrical contacts 14 .

[0053] FIG. 2A is a schematic diagram showing an exploded view of device 10 and a method of manufacturing device 10 according to some embodiments of the present invention. In some optional embodiments of the present invention, substrate 12 is a multi-layer substrate. Contacts 14, wires 18, and optionally wires 20 are printed on an inner layer 123 of substrate 12, preferably using a silver-containing conductive ink. A printed circuit board 162 of connector 16 is attached to inner layer 123 at elongated extension 22 of substrate 12. Printed circuit board 162 is at or near the end of extension 22 opposite section 24. Printed circuit board 162 serves as a carrier substrate for electronic elements of connector 16 (e.g., conductive terminals, connector contacts, elements of authentication tag, if provided). Printed circuit board 162 is optionally, and preferably, made from a thermoplastic polymer, such as, but not limited to, polyethylene terephthalate, polyethylene naphthalate, polybutylene terephthalate, polytrimethylene terephthalate, polycyclohexylene terephthalate, and the like.

[0054] The substrate 12 may further comprise a cover 121 attached to the inner layer 123 by an adhesive layer 122. The cover 121 is non-conductive and may be made from a non-conductive polymeric material such as, but not limited to, a thermoplastic elastomer. The cover 121 is flexible and preferably has a Shore A hardness of about 20 to about 50. An insulating layer 124 is attached to the cover 121 and the inner layer opposite the adhesive layer 122. The insulating layer 124 is formed to cover the conductive lines 18 and 20. An additional adhesive layer 126 is applied to the insulating layer 124 and to section 24 of the inner layer 123. The adhesive layer 126 has an opening 127 that exposes the contacts 14. A bolus 32 is then applied to the adhesive layer 126, covering the opening 127 and therefore the contacts 14, and a removable protective film 34 is attached to the adhesive layer 126 to protect the contacts 14, the bolus 32, and the adhesive layer 126.

[0055] A pair of non-conductive connecting members 164, 166 of the connector 16 are above and below the printed circuit board 162. The connecting members 164, 166 are shaped and sized to fit a cable connector (not shown, see FIGS. 3A and 3B) to allow the connector 16 to connect the device 10 to a cable. The connecting members 164, 166 are optionally, but preferably, made of a thermoplastic polymer that is harder than the printed circuit board 162. Representative examples of suitable polymers for the connecting members 164, 166 include, but are not limited to, acrylonitrile butadiene styrene, polyacetal, polycarbonate, and the like.

[0056] The printed circuit board 162 and the connecting members 164, 166 can be attached to the end of the extension 22 or offset therefrom. A connection at the end of the extension 22 is useful when it is desired that the connector 16 be a single-sided connector, with conductive lines present on only one side of the connector 16. A connection offset from the end of the extension 22 is useful when it is desired that the connector 16 be a double-sided connector, with conductive lines present on both sides of the connector 16. In the latter embodiment, following attachment of one or more of the connecting members 164, 166, the inner layer 123 having the conductive lines 18 is folded over the respective connecting members. An image showing such folding is shown in FIG. 2B.

[0057] As mentioned above, when the device 10 is in use, electrical communication is established between the device 10 and a data processor via a cable. Figures 3A and 3B are schematic diagrams illustrating a connection between the connector 16 and a cable 28 by a cable connector 26 according to some embodiments of the present invention for establishing such a connection. Because the cable connector 26 is typically at the distal end of the cable 28, the connector 26 is interchangeably referred to herein as the distal cable connector 26. The connector 16 is compatible in size, structure, and function with the distal cable connector 26 to mate with the distal cable connector 26 and allow electrical communication to be established therebetween. Figures 3A and 3B show the connectors 16 and 26 in a disconnected state (Figure 3A) and a connected state (Figure 3B). Although Figures 3A and 3B show a schematic configuration in which the connector 16 is a male connector and the connector 26 is a female connector, configurations in which the connector 16 is a female connector and the connector 26 is a male connector are also contemplated.

[0058] Cable 28 receives a transmit signal Tx from a signal generator (not shown) and transmits this signal to one of the contacts 14 via connector 16. Cable 28 also receives a receive signal Rx from the other of the contacts 14 via connector 16 and transmits these signals to a signal processor (not shown). In embodiments in which device 10 includes a tag 30 and the tag 30 includes an electronic chip, the authentication signal generated by the tag 30 may be transmitted to the signal processor via cable 28.

[0059] In any of the embodiments described herein, the total thickness t of the connector 16 and the cable connector 26 after being connected is optionally, but preferably, less than 4 mm. This also allows the connector 26 to be placed between the subject and the bed (when the subject is in a supine position and the device 10 is connected to the subject's back region) without causing discomfort to the subject, unlike conventional systems. If the device 10 includes an authentication tag 30, the aforementioned thickness of less than 4 mm can also include the authentication tag 30.

[0060] The cable 28 is preferably a multi-connection cable having multiple cable connectors 26 at a distal end of the cable 28, allowing multiple respective devices, such as the device 10, to be connected to the cable 28. Figures 4A and 4B are schematic diagrams of the multi-connection cable 28 in an embodiment in which the cable 28 is provided with four cable connectors 26 at its distal end 42, designated UR, LR, UL, and LL, each designated for connection to a single-use connector 16 attached to a different part of the subject's body (e.g., the upper right region, the lower right region, the upper left region, and the lower left region of the upper body). It is understood that the cable 28 can be provided with any number of connectors at its distal end 42, as desired, depending on the number of devices to be connected to the cable 28. The proximal end 44 of the cable 28 is provided with a proximal connector 46 that is compatible with a connector panel of a signal processor (not shown).

[0061] Each connector 26 is connected to a braid 48 of conductive wires, for example by a dedicated printed circuit board 261 in the connector 26, and all braids 48 are joined at a braid coupler 50 to form a combined braid 52 that connects to the proximal connector 46. In some embodiments of the invention, one or more of the conductive wires in the braid 52 are protected. The different conductive wires, for example the wires conducting the transmit signals Tx and the wires conducting the receive signals Rx, are preferably protected by separate electrical shields. In various exemplary embodiments of the invention, the conductive wires in the combined braid 52 are configured to establish electrical communication between each of the distal connectors 26 and the proximal connector 46 according to a connection scheme that is specific to each of the distal connectors and ensures that the Tx and Rx signals flowing in the different conductive wires are separated from each other at the proximal connector 46, unlike the connection schemes of the other distal connectors.

[0062] A representative non-limiting example of a connection scheme between connectors 26 and 46 is shown diagrammatically in FIG. 4B. In this example, each cable connector 26 is a 5-pin connector, optionally and preferably a linear 5-pin connector. The pins of connectors 26 are arranged in series from 1 to 5, and in this example, pins number 2 and 4 are combined to provide a protective function, such that each braid 48 is a 4-wire braid. Typically, when connector 16 is connected to connector 26, electrical communication is established between floating wire 20 of device 10 and pins number 2 and 4 of connector 26. Each of the conductive wires of braids 48 and 52 that are connected to one of pins 1, 3, and 5 of distal connector 26 is protected by a shield that is spaced apart from the other shields. A protective wire in braids 48 and 52 (connected to pins 2 and 4 in this example) can short between all distal connectors.

[0063] Of the non-protected pins 1, 3 and 5, one carries a Tx signal and one carries an Rx signal. For example, the conductive wire of the braid 48, 52 connected to pin 1 can carry a Tx signal, the conductive wire of the braid 48, 52 connected to pin 5 can carry an Rx signal, and all conductive wires of the braid 48, 52 connected to pin 3 can perform the function of authentication. In this case, when the connector 16 is connected to the connector 26, two separate electrical communications are established between the conductive wire 18 of the device 10 and pins number 1 and 5 of the connector 26, respectively, and another separate electrical communication is established between the authentication wire 21 of the device 10 and pin number 3 of the connector 26. The authentication wires of the braids 48 and 52 (connected to pin number 3 of the connector 26 in this embodiment) can be shorted between the braids. The shorting (between the protection wires and / or the authentication wires) can be done at the proximal connector 46 or, more preferably, at the braid coupler 50, thus reducing the number of conductive wires in the braid 52.

[0064] In the illustrated non-limiting embodiment of Fig. 4B, the proximal connector 46 comprises 12 pins numbered 1 to 12, where pin numbers 9 and 12 are combined to perform the function of protection. The connection schemes are different from each other in the sense that for each distal connector 26, different Tx and Rx signals are transmitted through different pins of the proximal connector 46. In this embodiment, the Tx and Rx signals of connector UR are transmitted through pin numbers 3 and 8 of the proximal connector 46, the Tx and Rx signals of connector LR are transmitted through pin numbers 7 and 4 of the proximal connector 46, the Tx and Rx signals of connector UL are transmitted by pin numbers 6 and 1 of the proximal connector 46, and the Tx and Rx signals of connector LL are transmitted by pin numbers 2 and 5 of the proximal connector 46.

[0065] The present embodiment contemplates one of two scenarios for making the connection between the connector 16 of the device 10 and the distal connector 26 of the cable 28.

[0066] In the first scenario, the connector 16 is orientation specific such that mating between the connector 16 and the connector 26 is only established in one orientation and not in a flipped orientation. This can be ensured by making the connector 16 and the connector 26 asymmetrical with respect to a 180° flip such that when one of the connectors 16 and the connector 26 is flipped relative to the proper orientation for connection, an operator cannot mate the connectors 16 and the connector 26 even if they are aligned laterally. Alternatively, the connector 16 can be single-sided, with electrical contacts on only one of its front and back sides, such that when one of the connectors 16 and the connector 26 is flipped relative to the proper orientation for connection, an operator can mate the connectors 16 and the connector 26 but electrical communication is not established. The advantage of the first scenario is that it prevents human error with respect to the connection between the connector 16 and the connector 26. In the first scenario, the arrangement of the respective conductive lines 18 of the device 10 is specific to the body part to which the respective device is attached.

[0067] To assist the user in properly positioning each of the devices 10 on the subject's body and connecting it to the appropriate cable connector 26 in the first scenario, visual aids such as markings on the respective devices or on the packaging containing the respective devices may be displayed. The markings may indicate the body part to which the device is attached. In these embodiments, such or similar markings are also optionally, and preferably, provided on the cable connectors 26 that connect to the respective devices once attached to the respective body parts. Representative examples of such visual aids are shown diagrammatically in FIGS. 5A-5E. FIG. 5A shows the distal end 42 of the cable 28, where each of the distal cable connectors 26 (in this example, four cable connectors) has markings 56 indicating a different body part of the subject. FIGS. 5B-5E show multiple packages 54 of the devices 10 (in this example, four packages) with markings 56 similar to the markings on the distal cable connectors 26, allowing the practitioner to attach each device 10 to its appropriate location and further connect it to the appropriate distal cable connector.

[0068] In the second scenario, the connector 16 has a symmetrical shape such that mating between the connector 16 and the connector 26 can be established in either one of two inverted orientations. In these embodiments, the connector 16 is double-sided with electrical contacts on both its front and back sides, so that electrical communication is established for either of two inverted orientations of the connector 16 and the connector 26 relative to each other. For example, the inverted orientation can correspond to switching of the lines in the cable 28 carrying the Rx and Tx signals, such that one orientation can be used when the device is attached to the posterior side of the body, but the inverted orientation can be used when the device is attached to the ventral side of the body. The connection scheme described above with respect to FIG. 4B illustrates such a switch (e.g., corresponding to switching between pin numbers 1 and 5 of the distal connector 26).

[0069] The advantage of the second scenario is that the device 10 does not need to be specific to the body part to which it is attached, and therefore, in the second scenario, all devices 10 included in a kit for use in bioimpedance measurements can have the same shape, size, and arrangement of conductive lines.

[0070] In a second aspect, the device 10 can be packaged with a label indicating that the device is for attachment to each of a number of different locations on the subject's body, more preferably the upper half of the subject's body. Figure 6A shows an exemplary label indicating eight such different locations, including, but not limited to, the left upper abdominal region, the right upper abdominal region, the left lower abdominal region, the right lower abdominal region, the left upper back region, the right upper back region, the left lower back region, and the right lower back region. In these embodiments, each of the distal connectors 26 is optionally, but preferably, marked with two markings indicating the appropriate body site for which the distal connector is intended for each of its two orientations.

[0071] Two representative examples of eight possible markings 56 are shown in Figures 6B and 6C. The markings 56 shown in Figures 6B and 6C can be provided on the front and back sides of the same distal connector 26. Figure 6B shows markings indicating that each orientation is suitable for connecting the respective distal connector 26 to a device 10 attached to the left upper dorsal region, and Figure 6C shows markings indicating that each orientation is suitable for connecting the respective distal connector 26 to a device 10 attached to the left upper abdominal region. One of ordinary skill in the art given the details provided herein will know how to provide markings on other distal connectors.

[0072] FIG. 7 is a schematic block diagram illustrating a bioimpedance measurement system 710 according to some embodiments of the present invention. The system 710 typically includes a signal generation system 714, a signal processing system 728, and a connector panel 730. The proximal connector 46 of the multi-connection cable 28 is connected to a control panel 730. The distal connection 26 of the cable 28 is connected to a number of devices 10 attached to the subject's body 713. The signal generation system 714 provides one or more output electrical Tx signals 716 and transmits the Tx signals 716 to the connector panel 730. The connector panel 730 transmits the signals to the devices 10 via the cable 28. The devices 10 detect one or more input electrical signals Rx 736 and transmit the Rx signals to the connector panel 730 via the cable 28. The panel 730 transmits the Rx signals 736 to the processing system 728.

[0073] The processing system 728 functions to provide monitoring information related to the hemodynamic status of the subject. The system 728 receives signals, processes the signals, and generates an output related to the processed signals. The output is preferably a graphical output, which is sent to a computer readable medium, such as a computer display card, a network card, or a memory medium. The output can be read from the computer readable medium by a local or remote computer and displayed, for example, on a display device. The hemodynamic status of the subject can be calculated based on the Rx signals using any technique known in the art, such as, but not limited to, the techniques disclosed in WO 2004 / 098376, WO 2006 / 087696, WO 2008 / 129535, WO 2009 / 022330, and WO 2010 / 032252, the contents of which are incorporated herein by reference. Representative examples of characteristics that may be calculated according to some embodiments of the present invention include stroke volume (SV), cardiac output (CO), ventricular ejection time (VET), cardiac index (CI), thoracic fluid volume (TFC), total peripheral resistance index (TPRI), vascular compliance, and any combination thereof. Optionally, but preferably, the processing system 728 performs the processing digitally. In these embodiments, the processing system 728 may include an analog to digital converter and a digital data processor or digital signal processor.

[0074] The signal provided by the generating system 714 is preferably an alternating current (AC) signal that can be of any frequency. The inventors have found that high frequency signals are useful, but it is not intended to limit the scope of the invention to any particular frequency. Specifically, the frequency of the transmitted signal can be below, within, or above the high frequency range. Exemplary frequency ranges suitable for this embodiment include, but are not limited to, 20KHz to 800KHz, e.g., about 75KHz. The current generated by the signal generating system of this embodiment flows through the organ, causing a voltage drop due to the impedance of the body. The input high frequency signal is typically, but not obligatorily, related to the impedance of the subject's organ. In various exemplary embodiments of the invention, the parameters (e.g., frequency, amplitude, phase) of the output signal(s) are selected such that the input signal is indicative of the impedance of the organ.

[0075] As used herein, the term "about" means ±10%.

[0076] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and / or as excluding the incorporation of features of other embodiments.

[0077] The term "optionally" is used herein to mean "provided in some embodiments and not in other embodiments." Any particular embodiment of the invention may include multiple "optional" features, unless such features conflict.

[0078] The terms "comprises," "comprising," "includes," "having" and their conjugates mean "including but not limited to."

[0079] The term "consisting of" means "including and limited to."

[0080] The term "consisting essentially of" means that the composition, method, or structure may include additional ingredients, steps, and / or components only if the additional ingredients, steps, and / or components do not materially change the basic and novel characteristics of the claimed composition, method, or structure.

[0081] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0082] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to have all the possible subranges specifically disclosed, as well as the individual numerical values ​​contained within that range. For example, the description of a range such as 1-6 should be considered to have the specifically disclosed subranges, such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, etc., as well as the individual numerical values ​​contained within that range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0083] Whenever a numerical range is given herein, it is meant to include any stated number (fractional or integer) within the stated range. The phrases "ranging between" a first stated number and a second stated number, and "ranging from" a first stated number to a second stated number, are used interchangeably herein and are intended to include the first stated number, the second stated number, and all fractions and integers therebetween.

[0084] It will be appreciated that certain features of the present disclosure, although described for clarity in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the present disclosure that are described for brevity in the context of a single embodiment may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the present invention. Certain features described in the context of various embodiments are not to be construed as essential features of those embodiments, unless the embodiment is ineffective without those elements.

[0085] Various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below find experimental support in the following examples. EXAMPLES

[0086] Reference is now made to the following examples, which together with the above descriptions illustrate some embodiments of the invention in a non-limiting fashion.

[0087] An experiment was performed to investigate the ability of the device 10 and cable 28 of the present embodiment to reduce crosstalk and noise. The experiment included measuring the Rx signal while one of the leads was disconnected. The results are shown in Figures 8A and 8B, where Figure 8A shows the signal received using a conventional electrode and Figure 8B shows the signal received using the device 10 of the present embodiment. As shown in Figure 8A, even after one of the leads is disconnected, the electrode still picks up a signal, indicating crosstalk between the wires leading from the electrode to the signal processor. In contrast, Figure 8B shows that no signal is received after disconnection, indicating no crosstalk within the device 10 and cable 28.

[0088] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0089] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually incorporated by reference. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. To the extent section headings are used, they should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are incorporated herein by reference in their entirety.

Claims

1. 1. A kit for transmitting and detecting a signal, said kit comprising: a multi-connection cable having a plurality of cable connectors at a distal end of the multi-connection cable for establishing electrical communication between each of the plurality of cable connectors and a system for measuring bioimpedance connectable to a proximal end of the multi-connection cable; a plurality of devices for transmitting and sensing signals, each device comprising a non-conductive substrate adhereable to a subject's skin, a first electrical contact and a second electrical contact printed on the non-conductive substrate, and a disposable connector; Equipped with A kit, wherein each single-use connector is connectable to a respective cable connector of the multi-connection cable such that the combined thickness of each single-use connector and each cable connector, once connected, is less than 4 mm.

2. 2. The kit of claim 1, wherein the length of each device from the first electrical contact and the second electrical contact to the single-use connector is less than 25 cm.

3. 3. The kit of claim 2, wherein each device comprises printed conductive lines leading from the first electrical contact and the second electrical contact to the disposable connector.

4. 2. The kit of claim 1, wherein the single-use connector comprises a first conductive wire connected to the first electrical contact, a second conductive wire connected to the second electrical contact, and at least one floating conductive wire between the first conductive wire and the second conductive wire.

5. The kit of claim 4 , wherein the conductive lines are printed conductive lines.

6. The kit of claim 3 , wherein the conductive wire and the first and second electrical contacts are in flush engagement.

7. 2. The kit of claim 1, wherein the single-use connector is attached to an integral extension of the non-conductive substrate such that the single-use connector, the non-conductive substrate, and the cable connector are parallel to one another after being connected to the single-use connector.

8. 2. The kit of claim 1, wherein the single-use connector comprises an authentication tag for authenticating each of the devices, and the total thickness of less than 4 mm includes the single-use connector, the authentication tag, and the cable connector.

9. 9. The kit of claim 8, wherein the authentication tag comprises an electronic chip having an internal clock or counter and is configured to generate an alarm signal in response to a state of the internal clock or counter and to transmit the alarm signal to the system via the multi-connection cable.

10. 10. The kit of claim 9, wherein the authentication tag comprises an electronic chip having an internal clock or counter, and is configured to generate an alarm signal in response to a state of the internal clock or counter, and to transmit the alarm signal to the system via the multi-connection cable.

11. 10. The kit of claim 1, wherein the single-use connector is orientation specific such that a fit between the single-use connector and the cable connector is established only in one orientation and not in an inverted orientation.

12. 12. The kit of claim 11, wherein each of the plurality of devices comprises markings or is packaged in a separate package comprising markings indicating the parts of the subject's body to which the plurality of devices are attached.

13. 13. The kit of claim 12, wherein each of the plurality of devices comprises markings or is packaged in separate packaging that comprises markings indicating the part of the subject's body to which the device is to be attached.

14. 14. The kit of claim 13, wherein each cable connector includes markings indicating a device to be connected to the cable connector by the respective single-use connector.

15. 15. The kit of claim 14, wherein each cable connector includes indicia indicating a device to be connected to the cable connector by the respective single-use connector.

16. 10. The kit of claim 1, wherein the single-use connector has a symmetrical shape such that engagement between the single-use connector and the cable connector can be established in either of two inverted orientations.

17. 17. The kit of claim 16, wherein at least one device of the plurality of devices is packaged with a label indicating that the at least one device is for attachment to each of eight different locations on the upper body of a subject.

18. 20. The kit of claim 17, wherein at least one device of the plurality of devices is packaged with a label indicating that the at least one device is for attachment to each of eight different locations on a subject's upper body.

19. 20. The kit of claim 18, wherein the eight different locations include the left upper abdominal region, the right upper abdominal region, the left lower abdominal region, the right lower abdominal region, the left upper back region, the right upper back region, the left lower back region, and the right lower back region.

20. 1. A method for transmitting and detecting a signal, comprising: a multi-connection cable having a plurality of cable connectors at a distal end of the multi-connection cable for establishing electrical communication between each of the plurality of cable connectors and a system for measuring bioimpedance connectable to a proximal end of the multi-connection cable; providing a kit including a plurality of devices for transmitting and sensing signals, each device comprising a non-conductive substrate adhereable to a subject's skin, first and second electrical contacts printed on the non-conductive substrate, and a disposable connector; each single-use connector is connectable to a respective cable connector of the multi-connection cable such that a combined thickness of the respective single-use connector and each cable connector after connection is less than 4 mm; attaching said plurality of devices to a subject's skin at a respective plurality of different locations; connecting the multi-connection cable between the plurality of devices and a connector panel of a bioimpedance measurement system; The method includes:

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