Devices and methods for sensing signals from a body

Abstract

Kit for transmitting and sensing signals, comprising: a multi-connection cable having a plurality of cable connectors at a distal end of the cable for establishing electrical communication between each cable connector and a system for measuring bioimpedance capable of being connected to a proximal end of the cable; and a plurality of devices for transmitting and sensing signals. Each device includes a non-conductive substrate capable of adhering to the skin of a subject, first and second electrical contacts printed on the substrate, and a disposable connector. Each disposable connector is capable of connecting to a compatible cable connector of the cable such that, once connected, the combined thickness of the disposable connector and the compatible cable connector is less than 4 mm.

Description

[0001] Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 869,066, filed on Jul. 1, 2019, the content of which is incorporated herein by reference as if fully set forth herein. Technical Field

[0003] In some embodiments of the present invention, the present invention relates to a medical device, and more particularly, but not exclusively, to devices and methods for sensing signals (such as, but not limited to, radio frequency signals from the body). Background Art

[0004] Techniques related to the measurement of the electrical properties of organs (such as bioimpedance measurement) are well known. Various methods using bioimpedance are found in: International Publication Nos. WO 2004 / 098376, WO2006 / 087696, WO 2008 / 102362, WO 2009 / 022330 and WO 2010 / 032252, WO 2013 / 014671, the content of which is hereby incorporated herein by reference.

[0005] For example, the '696 application discloses transmitting an output radio frequency signal to a subject's organ, receiving an input radio frequency signal from the organ, determining the phase shift of the input signal relative to the output signal, and using the phase shift to calculate the subject's cardiac output.

[0006] The '362 application describes a patch for transmitting and sensing radio frequency signals. Electrical contacts are fixed at a certain distance between them to reduce the effect of variable electrode-to-electrode distance on the measurement. The patch is connected to a monitoring system through a connector having conductive members, wherein each electrical contact is in electrical communication with a conductive member through a different wire. Summary of the Invention

[0007] According to one aspect of some embodiments of the present invention, there is provided a device for transmitting and sensing signals. The device includes a non-conductive substrate capable of adhering to a subject's skin; first and second electrical contacts printed on the substrate; a disposable connector capable of connecting to a compatible cable connector of a cable, the cable receiving signals from the contacts through the disposable connector for transmitting the signals to a signal processor of a system for measuring bioimpedance. The disposable connector has a symmetric shape such that mating between the disposable connector and the compatible cable connector is established in either of two flipped orientations.

[0008] According to some embodiments of the present invention, the device is packaged with a label indicating that the device is for attachment to each of a plurality of different parts of a subject's body.

[0009] According to some embodiments of the present invention, the plurality of different regions include: a ventral upper left region, a ventral upper right region, a ventral lower left region, a ventral lower right region, a dorsal upper left region, a dorsal upper right region, a dorsal lower left region, and a dorsal lower right region.

[0010] According to some embodiments of the present invention, the length of the device from the contact to the disposable connector is less than 25 cm.

[0011] According to some embodiments of the present invention, the disposable connector is attached to an integral extension of the non-conductive substrate such that the disposable connector and the non-conductive substrate are parallel to each other.

[0012] According to some embodiments of the present invention, the device includes an authentication label mounted on, printed on, or integrated with the disposable connector, the authentication label being configured to authenticate the device, wherein the combined thickness of the disposable connector and the authentication label is less than 4 mm.

[0013] According to some embodiments of the present invention, the authentication label includes 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 transmit the alarm signal to the system via a cable.

[0014] According to one aspect of some embodiments of the present invention, a kit is provided. The kit includes a plurality of devices for transmitting and sensing signals, wherein all the devices are identical in appearance and structure, and wherein each device is as described above and optionally and preferably is the device further exemplified below.

[0015] According to one aspect of some embodiments of the present invention, a kit for transmitting and sensing signals is provided. The kit includes a plurality of devices for transmitting and sensing signals, wherein each device is as described above and optionally and preferably is the device further exemplified below. The kit further includes a multi-connection cable having a corresponding plurality of cable connectors at the distal end of the cable, wherein each cable connector is compatible with a disposable connector of one of the devices.

[0016] According to some embodiments of the present invention, for each pair of the disposable connector and the cable connector of the kit, at least one of the disposable connector and the cable connector includes a mark indicating a connection orientation depending on the body part of the subject to which the device is to be attached.

[0017] According to some embodiments of the present invention, all the devices in the kit are identical in appearance and structure.

[0018] According to some embodiments of the present invention, a disposable connector is attached to an integral extension of a non-conductive substrate such that the disposable connector, the non-conductive substrate, and a cable connector after the disposable connector are all parallel to each other.

[0019] According to some embodiments of the present invention, there are four devices in the kit.

[0020] According to one aspect of some embodiments of the present invention, a method of transmitting and sensing signals is provided. The method includes attaching a plurality of devices for transmitting and sensing signals to a subject's body, where each device is as described above and optionally and preferably is a device further illustrated below. The method includes connecting a multi-connection cable between the plurality of devices and a connector panel of a bioimpedance measurement system.

[0021] According to one aspect of some embodiments of the present invention, a kit for transmitting and sensing signals is provided. The kit includes a multi-connection cable having a plurality of cable connectors at the distal end of the cable for establishing electrical communication between each cable connector and a signal processor of a system for measuring bioimpedance that can be connected to the proximal end of the cable, and a plurality of devices for transmitting and sensing signals, where each device includes a non-conductive substrate capable of adhering to the skin of a subject, first and second electrical contacts printed on the substrate, and a disposable connector. According to some embodiments of the present invention, each disposable connector can be connected to a compatible cable connector of the cable such that once connected, the combined thickness of the disposable connector and the compatible cable connector is less than 4 mm.

[0022] According to some embodiments of the present invention, the disposable connector of the kit is orientation-specific such that mating between the disposable connector and the compatible cable connector is established only in one orientation and not in the flipped orientation. According to some embodiments of the present invention, each device of the kit includes a marking or is packaged in a separate package including a marking that indicates the body part of the subject to which the device is to be attached. According to some embodiments of the present invention, each cable connector includes a marking that indicates the device to be connected to the cable connector via the corresponding disposable connector.

[0023] According to some embodiments of the present invention, the disposable connector has a symmetric shape such that mating between the disposable connector and the cable connector is established in either of two flipped orientations. According to some embodiments of the present invention, at least one device in the kit of devices is packaged with a label that indicates that the at least one device is for attachment to each of a plurality of different parts of a subject's body, optionally and preferably to an upper part of the subject's body. According to some embodiments of the present invention, the plurality of different parts include: a ventrolateral upper left region, a ventrolateral upper right region, a ventrolateral lower left region, a ventrolateral lower right region, a dorsolateral upper left region, a dorsolateral upper right region, a dorsolateral lower left region, and a dorsolateral lower right region. According to some embodiments of the present invention, for each pair of disposable connector and cable connector, at least one of the disposable connector and the cable connector includes a marking that indicates the connection orientation depending on the part of the subject's body to which the device is to be attached. According to some embodiments of the present invention, all devices are identical in appearance and structure. According to some embodiments of the present invention, there are four devices.

[0024] According to some embodiments of the present invention, the length of each device in the kit from the contact to the disposable connector is less than 25 cm.

[0025] According to some embodiments of the present invention, each device in the kit includes a printed wire that leads from the contact to the disposable connector.

[0026] According to some embodiments of the present invention, the disposable connector includes a first wire connected to a first electrical contact, a second wire connected to a second electrical contact, and at least one floating wire between the first and second wires.

[0027] According to some embodiments of the present invention, the wires are printed wires.

[0028] According to some embodiments of the present invention, the wires and the printed electrical contacts are in the same plane.

[0029] According to some embodiments of the present invention, the disposable connector is attached to an integral extension of a non-conductive substrate such that the disposable connector, the non-conductive substrate, and the cable connector after being connected to the disposable connector are all parallel to each other.

[0030] According to some embodiments of the present invention, the disposable connector includes an authentication label for authenticating the corresponding device, and wherein the thickness of less than 4 mm includes the disposable connector, the authentication label, and the cable connector.

[0031] According to some embodiments of the present invention, the authentication label includes 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 transmit the alarm signal to the bioimpedance measurement system through the cable.

[0032] According to some embodiments of the present invention, the multi-connection cable includes separate electrical shields for the lines that conduct the transmitted signals and the lines that conduct the received signals.

[0033] According to one aspect of some embodiments of the present invention, a method for transmitting and sensing signals is provided. The method includes providing a kit as described above and optionally and preferably as further illustrated below; attaching the plurality of devices to the skin of a subject at corresponding plurality of different sites; and connecting the multi-connection cable between the plurality of devices and a connector panel of a system for measuring bio-impedance.

[0034] 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 the present invention, exemplary methods and / or materials will be described below. In case of conflict, the patent specification (including definitions) will control. In addition, the materials, methods, and examples are illustrative only and not intended to be necessarily limiting.

[0035] The implementation of the methods and / or systems of the embodiments of the present invention may include performing or completing selected tasks manually, automatically, or a combination of manual and automatic. In addition, depending on the actual instrumentation and equipment of the embodiments of the methods and / or systems according to the present invention, several selected tasks can be implemented using an operating system through hardware, software, or firmware, or a combination of the above.

[0036] For example, the hardware for performing selected tasks according to embodiments of the present invention can be implemented as a chip or a circuit. As software, the selected tasks according to embodiments of the present invention can be implemented as a plurality 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 the exemplary embodiments of the methods and / or systems as described herein are executed by a data processor (e.g., a computing platform for executing a plurality of instructions). Optionally, the data processor includes volatile memory for storing instructions and / or data and / or non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or a removable medium. Optionally, a network connection is also provided. Optionally, a display and / or a user input device, such as a keyboard or a mouse, are provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Some embodiments of the present invention are described herein by way of example only with reference to the drawings. Now specifically referring in detail to the drawings, it is emphasized that the details shown are exemplary and are for the purpose of discussing the embodiments of the present invention illustratively. In this regard, the description in conjunction with the drawings enables those skilled in the art to clearly understand how to implement the embodiments of the present invention.

[0038] In the drawings:

[0039] Figures 1A - 1C is a schematic illustration showing a perspective view of a device for transmitting and sensing signals according to some embodiments of the present invention( Figure 1A ), a front view( Figure 1B ), and a rear view( Figure 1C );

[0040] Figure 2A is a schematic illustration showing an exploded view of a device for transmitting and sensing signals according to some embodiments of the present invention;

[0041] Figure 2B is an image showing the folding of a wire on a connecting member according to some embodiments of the present invention.

[0042] Figure 3A and Figure 3B are schematic illustrations showing the connection between a connector and a cable through a cable connector according to some embodiments of the present invention;

[0043] Figure 4A and Figure 4B are schematic illustrations of a multi - connection cable in an embodiment where the cable includes four cable connectors;

[0044] Figure 5A is a schematic illustration of the distal end of a cable in an embodiment where each cable connector has a mark indicating a different body part of a subject;

[0045] Figures 5B - 5E shows multiple packages of the device with markings that allow a doctor to attach each device to its appropriate location and connect it to the appropriate distal cable connector;

[0046] Figure 6A is a schematic illustration showing labels for eight different locations on a subject's body according to various exemplary embodiments of the present invention;

[0047] Figure 6B and Figure 6C are schematic illustrations of two of eight possible markings that can be set on the front and back of a cable connector according to some embodiments of the present invention;

[0048] Figure 7 is a schematic block diagram showing a bio - impedance measurement system according to some embodiments of the present invention; and

[0049] Figure 8A and Figure 8B show the results of experiments conducted according to some exemplary embodiments of the present invention to study the ability of the devices and cables of these embodiments to reduce crosstalk and noise. Detailed implementation manners

[0050] In some embodiments of the present invention, the present invention relates to a medical device, and more specifically, but not exclusively, to a device and method for sensing signals, such as, but not limited to, radio frequency signals from the body.

[0051] Before explaining in detail at least one embodiment of the present invention, it should be understood that the application of the present invention does not have to be limited to the details of the construction and arrangement of the components and / or methods set forth in the following description and / or shown in the drawings and / or examples. The present invention can have other embodiments, or can be implemented or carried out in various ways.

[0052] The method of using bioimpedance measurement includes placing a plurality of electrodes on the patient's skin, usually in the chest area. Electrical signals are transmitted and received through the electrodes, and the change in the impedance of the subject's tissue over time is measured and correlated with cardiac parameters.

[0053] Due to various anatomical factors, the electrodes are usually placed on specific areas of the body to achieve a better correlation between the measured changes in bioimpedance and cardiac parameters. A typical arrangement for monitoring the electrical properties of a body part is a four-pole arrangement of electrodes attached to the subject's skin at the upper and lower regions of the upper part of the body. Each pair of electrodes is welded to the distal end of a cable, which is connected to a signal processor at its proximal end. The signal processor analyzes the signals received from the electrodes and correlates them with cardiac parameters.

[0054] The inventors of the present invention have found that welding the cable to the electrodes causes usability problems. For example, during surgery, the cable may become detached from the electrodes, resulting in signal loss. In such cases, it is often impossible to attach a new set of electrodes because it would interrupt the surgery.

[0055] The inventors of the present invention have also found that the wires inside the cable are not well protected from external noise signals and are not immune to crosstalk between the transmitting and receiving electrodes. The inventors of the present invention have found that this situation results in noisier signals and makes it difficult to detect the separation of the electrodes from the skin.

[0056] The inventors of the present invention have also found that bioimpedance measurements can also be performed by connecting the electrodes to the back area of the subject. However, while reducing this connection to practice, the inventors of the present invention have found that the electrodes cause discomfort to the subject, especially when the subject is in a supine position, and may also cause pressure sores or other types of injuries.

[0057] To find a solution to at least one of the above problems, the inventors of the present invention have designed a device and kit for transmitting and sensing signals. Now referring to the drawings, Figures 1A - 1CPerspective view ([ Figure 1A )、front view ([ Figure 1B ) and rear view ([ Figure 1C ) of a device 10 for transmitting and sensing signals according to some embodiments of the present invention. The device 10 may include a non-conductive substrate 12, two electrical contacts 14 printed on the substrate 12, and a disposable connector 16. Preferably, the device 10 is disposable as a whole. The back surface of the substrate 12 is generally capable of adhering to the skin of a subject. For example, the back surface of the substrate 12 may include an adhesive layer (not shown, see Figures 2A - 2B ) for attaching the back surface of the substrate 12 to the skin of the subject.

[0058] The substrate 12 is optionally and preferably of a multi-layer structure. A representative example of a multi-layer structure suitable for the substrate 12 is described below with reference to Figures 2A - 2B . The connector 16 is generally attached to an integral extension 22 of the non-conductive substrate 12 in such a way that the connector 16 and the substrate 12 are parallel to each other. This improves the comfort of the subject, especially when the device is located between the skin of the subject and the bed (e.g., when the subject is in a supine position, connected to the back area of the subject). This is different from conventional electrodes, which include connectors protruding from an adhesive substrate. The integral extension 22 is optionally and preferably elongated, with an aspect ratio of length to width of about 3 to about 10, for example about.

[0059] In any of the embodiments described herein, the thickness t of the connector 16 measured perpendicular to the substrate 12 is preferably less than 4 mm. In experiments conducted by the inventors, it was found that when the thickness of the connector 16 is less than 4 mm, most subjects do not notice it, it does not cause pressure sores or other types of damage, and thus significantly improves the comfort of the subject.

[0060] The contacts 14 are spaced apart from each other. One of the contacts 14 is for transmitting the transmit signal Tx to the body of the subject, and the other of the contacts 14 is for sensing the receive signal Rx from the body of the subject. The typical distance between the centers of the contacts 14 is from about 10 mm to about 70 mm, more preferably from about 20 mm to about 70 mm, more preferably from about 30 mm to about 70 mm, more preferably from about 40 mm to about 70 mm, more preferably from about 50 mm to about 70 mm, more preferably from about 55 mm to about 65 mm, more preferably from about 57 mm to about 62 mm, more preferably from about 57 mm to about 60 mm, or from about 58 mm to about 59 mm, such as about 58.5 mm. The inventors have found that this distance range between the entry point of the Tx signal and the exit point of the Rx signal provides significantly better results compared to other distances. The contacts 14 are typically printed on the portion 24 of the substrate 12, from which the extension 22 extends, and the portion 24 is typically wider than the extension 22. Typically, but not necessarily, the aspect ratio of the length to the width of the portion 24 is from about 0.5 to about 1.5. The total length of the device 10 from the contacts 14 to the connector 16 is typically less than 25 cm or less than 20 cm, such as from about 5 cm to about 15 cm. As explained below, the use of the device 10 includes establishing electrical communication between the device 10 and the signal processor via a cable, where the device 10 is connected to a cable connector at the distal end of the cable, and the signal processor is connected to a cable connector at the proximal end of the cable. Different from the device 10, the cable (including the connectors at its proximal and distal ends) can typically be used multiple times and thus is not manufactured as a disposable item. Therefore, from a cost perspective, it is advantageous to make the device 10 small enough (e.g., less than 25 cm or less than 20 cm or less than 15 cm), because in this case, a larger portion of the communication length between the contacts 14 and the signal processor is provided by the reusable non-disposable cable.

[0061] In some embodiments of the present invention, the device includes a gel mass 32 covering the contacts 14 at the back of the device 10. The mass 32 is for providing better electrical contact and impedance matching with the skin of the subject. The mass 32 can include any conductive gel, such as, but not limited to, a conductive hydrogel. In some embodiments of the present invention, at least a part of the back of the device 10 is covered by a removable protective film 34 for protecting the contacts 14, the mass 32, and the adhesive layer.

[0062] Device 10 also includes a pair of wires 18 that lead from the contact 14 to the connector 16. The wires 18 are optionally and preferably also printed on the substrate 12. In some embodiments of the present invention, device 10 also includes one or more floating wires 20 located between the wires 18. The advantage of these embodiments is that the floating wire 20 provides electrical shielding between the lines 18. Preferably, the floating wire 20 is also printed on the substrate 12. The wires 18 and 20 (when used) are preferably joined to the electrical contact 14 in the same plane.

[0063] In some embodiments of the present invention, device 10 includes an authentication label 30 that is mounted or printed on the connector 16, or otherwise integrated with the connector 16. The authentication label 30 is configured to authenticate device 10 when device 10 is connected to a bioimpedance measurement system. In any embodiment employing the label 30, the combined thickness t of the connector 16 and the label 30 is preferably less than 4 mm.

[0064] The authentication label 30 can be any machine-readable type known in the art, such as, but not limited to, a barcode or an electronic chip, such as an RFID chip, an EEPROM chip, or an RTLS chip. In some embodiments of the present invention, the electronic chip of the authentication label 30 includes 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 device 10 and generate an alarm signal when the device has been used for a period exceeding a preset period for which device 10 is recommended for single-use clinical use (e.g., the preset period is 30 minutes, or 1 hour, or 2 hours, or 6 hours, or 12 hours, or 24 hours, or 48 hours, etc.). In response to the alarm signal, the operator can replace the device. When the authentication label 30 includes an electronic chip, device 10 optionally and preferably includes a dedicated authentication wire 21 for transmitting signals (e.g., authentication signals, clock signals, alarm signals, etc.) to the signal processor. Preferably, the authentication wire 21 is also printed on the substrate 12 and preferably joined to the wires 18 and 20 (when used) and the electrical contact 14 in the same plane.

[0065] Figure 2AIt is a schematic illustration showing an exploded view of a device 10 and a method of manufacturing the device 10 according to some embodiments of the present invention. In some alternative embodiments of the present invention, the substrate 12 is a multi-layer substrate. The contacts 14, the wires 18 and optionally also the wire 20 are printed on the inner layer 123 of the substrate 12, preferably using a silver-containing conductive ink. The printed circuit board 162 of the connector 16 is attached to the inner layer 123 at the elongated extension 22 of the substrate 12. The printed circuit board 162 is located at or near the end of the extension 22 opposite the portion 24. The printed circuit board 162 serves as a carrier substrate for the electronic components of the connector 16 (e.g., conductive terminals, connector contacts, components of an authentication label if included, etc.). The printed circuit board 162 is optionally and preferably made of a thermoplastic polymer such as, but not limited to, polyethylene terephthalate, polyethylene naphthalate, polybutylene terephthalate, polypropylene terephthalate, polycyclohexylene terephthalate, etc.

[0066] The substrate 12 may further include a cover layer 121 attached to the inner layer 123 through an adhesive layer 122. The cover layer 121 is non-conductive and may be made of, for example, a non-conductive polymeric material (such as, but not limited to, a thermoplastic elastomer). Preferably, the cover layer 121 is flexible and has a Shore A hardness ranging from about 20 to about 50. The isolation layer 124 is attached to the inner layer, opposite the cover layer 121 and the adhesive layer 122. The isolation layer 124 is shaped to cover the wires 18 and 20. An additional adhesive layer 126 is applied to a portion of the isolation layer 124 and the inner layer 123. The adhesive layer 126 has an opening 127 exposing the contact 14. Then, a blob 32 is applied to the adhesive layer 126 to cover the opening 127 and thus also cover the contact 14, and a removable protective film 34 is attached to the adhesive layer 126 to protect the contact 14, the blob 32, and the adhesive layer 126.

[0067] A pair of non-conductive connecting members 164, 166 of the connector 16 are located above and below the printed circuit board 162. The connecting members 164, 166 are compatible in shape and size with a cable connector (not shown, see Figure 3A and Figure 3B ), such that the device 10 can be connected to a cable through the connector 16. The connecting members 164, 166 are optionally and preferably made of a thermoplastic polymer harder than the printed circuit board 162. Representative examples of polymers suitable for the connecting members 164, 166 include, but are not limited to, acrylonitrile butadiene styrene, polyoxymethylene, polycarbonate, etc.

[0068] The printed circuit board 162 and the connecting members 164, 166 can be mounted at the end of the extension 22 or offset from the end. When it is desired to make the connector 16 a single-sided connector (in a single-sided connector, the wires are only on one side of the connector 16), the connection at the end of the extension 22 is useful. When it is desired to make the connector 16 a double-sided connector (in a double-sided connector, the wires are on both sides of the connector 16), the connection offset from the end of the extension 22 is useful. In the latter embodiment, after one or more connecting members 164, 166 are mounted, the inner layer 123 with the wires 18 is folded over the corresponding connecting member. An image showing such folding is shown in Figure 2B as follows.

[0069] As described above, when using the device 10, electrical communication is established between the device 10 and the data processor via a cable. Figure 3A and Figure 3B are schematic diagrams showing the connection between the connector 16 and the cable 28. According to some embodiments of the present invention, such a connection is established by means of the cable connector 26. Since the cable connector 26 is typically located at the distal end of the cable 28, the connector 26 may be interchangeably referred to herein as the distal cable connector 26. The connector 16 is made compatible with the distal cable connector 26 in terms of size, structure, and function, thereby allowing them to mate and establish electrical communication therebetween. Figure 3A and Figure 3B show the connectors 16 and 26 in the disconnected ( Figure 3A ) and connected ( Figure 3B ) states. Although Figure 3A and Figure 3B schematically show a configuration in which the connector 16 is a male connector and the connector 26 is a female connector, a configuration in which the connector 16 is a female connector and the connector 26 is a male connector is also contemplated.

[0070] The cable 28 receives the transmitted signal Tx from a signal generator (not shown) and transmits the signal through the connector 16 to one of the contacts 14. The cable 28 also receives the received signal Rx from another contact 14 through the connector 16 and transmits these signals to a signal processor (not shown). In an embodiment where the device 10 includes the tag 30 and the tag 30 includes an electronic chip, the authentication signal generated by the tag 30 can be transmitted to the signal processor through the cable 28.

[0071] In any of the embodiments described herein, the combined thickness t of the connector 16 and the cable connector 26 (once connected) is optionally and preferably less than 4 mm. This allows the connector 26 to also be positioned between the subject and the bed (when the subject is in the supine position and the device 10 is connected to the back region of the subject), without causing discomfort to the subject, which is different from conventional systems. When the device 10 includes the authentication tag 30, the aforementioned thickness of less than 4 mm also includes the authentication tag 30.

[0072] The cable 28 is preferably a multi-connection cable having a plurality of cable connectors 26 at the distal end of the cable 28, thereby allowing a corresponding plurality of devices such as the device 10 to be connected to the cable 28. Figure 4A and Figure 4B is a schematic illustration of the multi-connection cable 28, in which, in this embodiment, the cable 28 includes four cable connectors 26 at its distal end 42, denoted as UR, LR, UL, and LL, each designated for connection to a disposable connector 16 attached to a different part of the subject's body (e.g., the upper right region, lower right region, upper left region, and lower left region of the upper part of the body, respectively). It should be understood that the cable 28 can include any number of connectors at its distal end 42, as needed, depending on the number of devices to be connected to the cable 28. The proximal end 44 of the cable 28 includes a proximal connector 46 compatible with the connector panel of a signal processor (not shown).

[0073] Each connector 26 is connected, for example, to a strand 48 of a wire through a dedicated printed circuit board 261 within the connector 26, and all the strands 48 are joined in a strand connector 50 to form a combined strand 52 connected to the proximal connector 46. In some embodiments of the present invention, one or more of the wires in the strand 52 are shielded. Preferably, different wires (e.g., a wire conducting a transmitted signal Tx and a wire conducting a received signal Rx) are shielded by separate electrical shields. In various exemplary embodiments of the present invention, the wires in the combined strand 52 are arranged to establish electrical communication between each distal connector 26 and the proximal connector 46 according to a connection scheme specific to the corresponding distal connector, which is different from the connection schemes of other distal connectors, and to ensure that the Tx and Rx signals flowing through different wires are separated from each other at the proximal connector 46.

[0074] A representative and non-limiting example of the connection scheme between the connectors 26 and 46 is in Figure 4Bis schematically shown in. In this example, each cable connector 26 is a five-pin connector, optionally and preferably a linear five-pin connector. The pins of the connector 26 are consecutively enumerated from 1 to 5, where, in this example, the 2nd and 4th pins are combined and used for shielding, such that each strand 48 is a four-wire strand. Typically, when the connector 16 is connected to the connector 26, electrical communication is established between the floating wire 20 of the device 10 and the 2nd and 4th pins of the connector 26. Each wire of the strands 48 and 52 connected to one of the 1st, 3rd, and 5th pins of the distal connector 26 is shielded by a shield that is spaced apart from other shields. The shield wires within the strands 48 and 52 (connected to the 2nd and 4th pins in this example) can be shorted between all distal connectors.

[0075] Among the unshielded 1st, 3rd, and 5th pins, one pin transmits the Tx signal, and one pin transmits the Rx signal. For example, the wires in the strands 48 and 52 connected to pin 1 can transmit the Tx signal, the wires in the strands 48 and 52 connected to pin 5 can transmit the Rx signal, and all wires in the strands 48 and 52 connected to pin 3 can be used for authentication. In this case, when the connector 16 is connected to the connector 26, two separate electrical communications are established between the wire 18 of the device 10 and the 1st and 5th pins of the connector 26 respectively, and an additional separate electrical communication is established between the authentication wire 21 of the device 10 and the 3rd pin of the connector 26. The authentication wires of the strands 48 and 52 (connected to the 3rd pin of the connector 26 in this example) can be shorted between the strands. The shorting (between the shield wires, and / or between the authentication wires) can be at the proximal connector 46, or more preferably at the strand connector 50, thus reducing the number of wires in the strand 52.

[0076] In Figure 4B the non-limiting example shown, the proximal connector 46 includes 12 pins enumerated from 1 to 12, where the 9th and 12th pins are combined and used for shielding. The connection schemes are different from each other in the sense that different Tx and Rx signals for each distal connector 26 are communicated through different pins of the proximal connector 46. In this example, the Tx and Rx signals of the connector UR are transmitted through the 3rd and 8th pins of the proximal connector 46, the Tx and Rx signals of the connector LR are transmitted through the 7th and 4th pins of the proximal connector 46, the Tx and Rx signals of the connector UL are transmitted through the 6th and 1st pins of the proximal connector 46, and the Tx and Rx signals of the connector LL are transmitted through the 2nd and 5th pins of the proximal connector 46.

[0077] This embodiment contemplates one of two scenarios for connection between the connector 16 of the device 10 and the distal connector 26 of the cable 28.

[0078] In the first scenario, the connector 16 is oriented such that mating between the connectors 16 and 26 is established in only one orientation and not in the flipped orientation. This can be ensured by making the connectors 16 and 26 asymmetrical with respect to a 180° flip, such that when one of the connectors 16 and 26 is flipped with respect to the correct connection orientation, the operator will not be able to mate the connectors 16 and 26, even if they are laterally aligned. Alternatively, the connector 16 can be single-sided, having electrical contacts on only one of its front and back faces, such that when one of the connectors 16 and 26 is flipped with respect to the correct connection orientation, the operator can mate the connectors 16 and 26, but electrical communication is not established. The advantage of the first scenario is that it prevents human error regarding the connection between the connectors 16 and 26. In the first scenario, the arrangement of the wires 18 of each device 10 is specific to the body part to which the respective device is to be attached.

[0079] To assist the user in correctly placing each device 10 on the subject's body and connecting it to the correct cable connector 26 in the first scenario, visual aids can be displayed, such as markings on the respective device or on the packaging containing the respective device. The marking can indicate the body part to which the device is to be attached. In these embodiments, such or similar markings are optionally and preferably also provided on the cable connector 26, which will be connected to the respective device once attached to the corresponding body part. Representative examples of such visual aids are schematically shown in Figures 5A - 5E FIG. Figure 5A FIG. shows the distal end 42 of the cable 28, where on each distal cable connector 26 (four cable connectors in this example), there are markings 56 indicating different body parts of the subject. Figures 5B - 5E FIG. shows multiple packages 54 of the devices 10 (four packages in this example), whose markings 56 are similar to those on the distal cable connectors 26, thus allowing the doctor to attach each device 10 to its appropriate site and also to connect it to the appropriate distal cable connector.

[0080] In the second scenario, the connector 16 has a symmetrical shape such that mating between the connectors 16 and 26 can be established in either of two flipped orientations. In these embodiments, the connector 16 is made double-sided, having electrical contacts on both its front and back faces, such that electrical communication is established for either of the two flipped orientations of the connectors 16 and 26 relative to each other. For example, the flipped orientation can correspond to a switch between the lines in the cable 28 that carry the Rx and Tx signals, such that one orientation can be used when the device is attached to the dorsal side of the body and the flipped orientation can be used when the device is attached to the ventral side of the body. As referred to aboveFigure 4B The described connection scheme illustrates such a switch (e.g., corresponding to a switch between pin 1 and pin 5 of the distal connector 26).

[0081] The advantage of the second scenario is that it is not necessary to make the devices 10 specific to the body parts to which they are attached. Thus, in the second scenario, all the devices 10 included in the kit for bioimpedance measurement can be the same in terms of the shape, size, and arrangement of the wires.

[0082] In a second aspect, the device 10 can be packaged with a label that indicates that the device is for attachment to each of a plurality of different parts of a subject's body, more preferably to the upper part of the subject's body. Figure 6A An exemplary label showing eight such different parts is shown, including, but not limited to, the left upper ventral region, the right upper ventral region, the left lower ventral region, the right lower ventral region, the left upper dorsal region, the right upper dorsal region, the left lower dorsal region, and the right lower dorsal region. In these embodiments, each distal connector 26 is optionally and preferably marked with two markings that indicate, for each of the two orientations of the distal connector, the suitable body part to which the distal connector is intended to be connected.

[0083] Representative examples of two of the eight possible markings 56 are shown in Figure 6B and Figure 6C as shown. Figure 6B and Figure 6C The markings 56 shown can be provided on the front and back of the same distal connector 26. Figure 6B Shows a marking indicating that the corresponding orientation is suitable for connecting the corresponding distal connector 26 to the device 10 attached to the left upper dorsal region, and Figure 6C shows a marking indicating that the corresponding orientation is suitable for connecting the corresponding distal connector 26 to the device 10 attached to the left upper ventral region. One of ordinary skill in the art with the details described herein will know how to provide markings to other distal connectors.

[0084] Figure 7Is a schematic block diagram showing a bioimpedance measurement system 710 according to some embodiments of the present invention. System 710 generally 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 the control panel 730. The distal connection 26 of the cable 28 is connected to a plurality of devices 10, which are attached to the body of the subject 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 signal to the devices 10 through the cable 28. The devices 10 sense one or more input electrical signals Rx 736 and transmit the Rx signals to the connector panel 730 through the cable 28. The panel 730 transmits the Rx signal 736 to the processing system 728.

[0085] The processing system 728 is used to provide monitoring information related to the hemodynamic state of the subject. System 728 receives the signal, processes the signal and generates an output related to the processed signal. Preferably, the output is a graphical output, which is transmitted to a computer-readable medium, such as the graphics card, network card or storage medium of a computer. The output can be read by a local or remote computer from the computer-readable medium and displayed on, for example, a display device. Any technique known in the art can be used to calculate the characteristics related to the hemodynamics of the subject based on the Rx signal. These techniques are, for example, but not limited to, the techniques disclosed in International Publication Nos. WO2004 / 098376, WO2006 / 087696, WO2008 / 129535, WO2009 / 022330 and WO2010 / 032252, and the disclosures of which are hereby incorporated herein by reference. Representative examples of the characteristics that can 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 content (TFC), total peripheral resistance index (TPRI), vascular compliance, and any combination of the above. Optionally and 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 a digital signal processor.

[0086] The signal provided by the generation system 714 is preferably an alternating current (AC) signal, which can be of any frequency. The inventors have found that radio frequency signals are useful, but do not intend to limit the scope of the present invention to any particular frequency. Specifically, the frequency of the transmitted signal can be below the radio frequency range, within the radio frequency range, or above the radio frequency range. Representative frequency ranges suitable for this embodiment include, but are not limited to, from 20 KHz to 800 KHz, for example, about 75 KHz. The current generated by the signal generation system of this embodiment flows through the organ and causes a voltage drop due to the impedance of the body. The input radio frequency signal is generally, but not necessarily, related to the impedance of the subject's organ. In various exemplary embodiments of the present invention, the parameters of the output signal (e.g., frequency, amplitude, phase) are selected such that the input signal indicates the impedance of the organ.

[0087] As used herein, the term "about" means ±10%.

[0088] 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 more preferred or advantageous than other embodiments and / or does not necessarily exclude features from other embodiments.

[0089] The phrase "optionally is" is used herein to mean "provided in some embodiments and not provided in other embodiments". Any particular embodiment of the present invention may include multiple "optional" features, unless these features are conflicting.

[0090] The terms "comprises", "comprising", "includes", "including", "has" and their inflected forms mean "including, but not limited to".

[0091] The term "consisting of" means "including, but not limited to".

[0092] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or parts, provided that the additional ingredients, steps, and / or parts do not materially alter the basic and novel features of the claimed composition, method, or structure.

[0093] As used herein, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0094] In this application, various embodiments of the present 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 present invention. Thus, the description of a range should be considered to have specifically disclosed all possible sub-ranges as well as individual numerical values within that range. For example, a description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of how broad the range is.

[0095] Whenever a numerical range is indicated herein, it means to include any cited number (fractional or integral) within the indicated range. The phrases "range between a first indicated number and a second indicated number" and "range from a first indicated number to a second indicated number" are used interchangeably herein and are intended to include the first and second indicated numbers and all fractional and integral numbers therebetween.

[0096] It should be understood that, for clarity, certain features of the present invention described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, the various features of the present invention described in the context of a single embodiment may also be provided separately, or in any suitable sub-combination, or in any other described embodiment suitable for the present invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment does not function without those elements.

[0097] The various embodiments and aspects of the present invention described above and claimed in the claims section are experimentally supported in the following examples.

[0098] Examples

[0099] Now refer to the following examples, which, together with the above description, illustrate some embodiments of the present invention in a non-limiting manner.

[0100] Experiments were conducted to study the ability of the device 10 and the cable 28 of this embodiment to reduce crosstalk and noise. The experiments included measuring the Rx signal during the separation of one of the leads. The results are shown in Figure 8A and Figure 8B where Figure 8A shows the signal received using a conventional electrode, and Figure 8B shows the signal received using the device 10 of this embodiment. As shown in Figure 8A even after separating one of the leads, the electrode still picks up a signal, indicating crosstalk between the wires leading from the electrode to the signal processor. Differently,Figure 8B It shows that no signal is received after separation, indicating that there is no crosstalk in device 10 and cable 28.

[0101] Although the present invention has been described in connection with specific embodiments thereof, it is apparent that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the present invention is intended to cover all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0102] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference in this specification. In addition, the citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. As to the use of section headings, they should not be construed as necessarily limiting. In addition, any priority documents of this application are hereby incorporated by reference in their entirety.

Claims

1. 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 cable connectors and a system for measuring bioimpedance capable of being connected to a proximal end of the multi-connection cable; And A plurality of devices for transmitting and sensing signals, each device comprising a non-conductive substrate capable of adhering to the skin of a subject, a first electrical contact and a second electrical contact printed on the substrate, and a disposable connector; Each disposable connector is capable of connecting to a compatible cable connector of the multi-connection cable such that once connected, the combined thickness of the disposable connector and the compatible cable connector is less than 4 mm.

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

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

4. The kit according to claim 1, wherein the disposable connector comprises a first conductor connected to the first electrical contact, a second conductor connected to the second electrical contact, and at least one floating conductor between the first conductor and the second conductor.

5. The kit according to claim 4, wherein the first conductor and the second conductor are printed conductors.

6. The kit according to claim 4, wherein the first conductor and the second conductor and the printed electrical contacts are in the same plane.

7. The kit according to claim 1, wherein the disposable connector is attached to an integral extension of the non-conductive substrate such that the disposable connector, the non-conductive substrate, and the cable connector after being connected to the disposable connector are all parallel to each other.

8. The kit according to claim 1, wherein the disposable connector comprises an authentication label for authenticating the corresponding device, and wherein the thickness of less than 4 mm includes the disposable connector, the authentication label, and the cable connector.

9. The kit according to claim 8, wherein the authentication label 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 transmit the alarm signal to the system via the multi-connection cable.

10. The kit according to claim 1, wherein the disposable connector is orientation-specific such that mating between the disposable connector and the compatible cable connector is established only in one orientation and not in a flipped orientation.

11. The kit according to claim 10, wherein each of the devices comprises a marking or is packaged in a separate package including a marking indicating the body part of the subject to which the device is to be attached.

12. The kit according to claim 11, wherein each cable connector includes a marking indicating the device to be connected to the cable connector through the respective disposable connector.

13. The kit according to claim 1, wherein the disposable connector has a symmetric shape such that mating between the disposable connector and the cable connector is established in either of two flipped orientations.

14. The kit according to claim 13, wherein at least one of the devices is packaged with a label indicating that the at least one device is for attachment to each of eight different sites on an upper portion of a subject's body.

15. The kit according to claim 14, wherein the eight different parts include: Ventral upper left region, ventral upper right region, ventral lower left region, ventral lower right region, dorsal upper left region, dorsal upper right region, dorsal lower left region, and dorsal lower right region.

16. A method of transmitting and sensing signals, the method comprising: Providing a kit, the kit including: 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 cable connectors and a system for measuring bioimpedance capable of being connected to a proximal end of the multi-connection cable; and A plurality of devices for transmitting and sensing signals, each device including a non-conductive substrate capable of adhering to a subject's skin, a first electrical contact and a second electrical contact printed on the substrate, and a disposable connector; Each disposable connector being capable of connecting to a compatible cable connector of the multi-connection cable such that, once connected, the combined thickness of the disposable connector and the compatible cable connector is less than 4 mm; Attaching the plurality of devices to the subject's skin at respective plurality of different sites; and Connecting the multi-connection cable between the plurality of devices and a connector panel of a bioimpedance measurement system.

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