Patent Description:
Various systems and devices can be used for sensing bioelectric data from a human body. For example, multi-electrode electrocardiogram (ECG) systems can be utilized for body-surface potential mapping by recording simultaneous ECG measurements from multiple sensors or electrodes applied to selected locations of a patient's body These sensors may be included in apparatus such as vests, bands, belts, straps, patches, wearable garments, t-shirts, bras, hats (e.g., for neural signals), etc..

Some ECG systems include multiple sensors generally arranged as part of a vest that is attached to a patient. These vests can be applied to a patient's torso for receiving bioelectric signals and, in some configurations, delivering stimulating signals to the patient. Bioelectric signals from the patient are detected by the sensors and transmitted via conductive paths to a medical monitoring system or apparatus such as an ECG base unit.

For example, one type of electrode vest is described in <CIT>, entitled SENSOR DEVICE. The described device includes a plurality of finger-like substrate portions of a flexible dielectric material that are releasably attachable to the thoracic region of a human body.

Further, for example, <CIT>, entitled SENSOR DEVICE WITH FLEXIBLE JOINTS, describes a sensor device that includes a flexible dielectric substrate, a plurality of sensors distributed on the substrate, and an electrically conductive network distributed on the substrate connecting the sensors to a terminal portion of the substrate. Integrated flexible joints permit a certain amount of elasticity in and allow relative movement between at least two of the sensors when the sensor device is placed onto the human body.

Such vests are generally provided in multiple sizes to accommodate various body types and sizes of patients. For example, <CIT>, entitled ELECTRODE PATCH MONITORING DEVICE, describes an electrode patch monitoring device that includes an array of electrodes formed on a flexible substrate. The electrode patch monitoring device may be available in a plurality of sizes. <CIT> is related to a bioelectric sensor device and methods.

The present invention relates to a bioelectric sensor device as defined in claim <NUM>.

The following aspects of the disclosure are useful for understanding the invention.

The techniques of this disclosure generally relate to bioelectric sensor devices, systems, and methods that include such devices. In one or more embodiments, the devices can be used for sensing bioelectric data from a human body. Further, in one or more embodiments, the devices can be used to help determine whether a patient will benefit from cardiac resynchronization therapy (CRT). If a patient is a viable candidate for such therapy, then one or more embodiments of the disclosed devices can be used to aid in placement of one or more leads of an implantable medical device and monitor cardiac activity to fine tune pacing and sensing parameters of the implanted device.

In one example, aspects of this disclosure relate to a bioelectric sensor device that includes a central portion and an arm that extends from the central portion, where at least a portion of the arm extends along an arm axis The central portion includes an anatomical alignment mark adapted to align the central portion with an anatomical feature of a lateral surface of a torso of a patient. Further, the arm is adapted to be disposed on an anterior or posterior surface of the torso. The bioelectric sensor device also includes a sensor disposed on the arm along the arm axis, and a connector electrically connected to the sensor.

In another example, aspects of this disclosure relate to a method that includes locating an anatomical feature on a lateral surface of a torso of a patient, disposing a central portion of a bioelectric sensor device on the lateral surface of the torso such that an anatomical alignment mark disposed on the central portion is aligned with the anatomical feature, and manipulating an arm of the bioelectric sensor device from an undeployed configuration to a deployed configuration, where the arm is connected to the central portion of the device. The method further includes disposing the arm on either an anterior or posterior surface of the torso of the patient, and electrically connecting a sensor disposed on the arm with a monitoring system.

The techniques of this disclosure generally relate to bioelectric sensor devices, systems, and methods that include such devices. In one or more embodiments, the devices can be used for sensing bioelectric data from a human body. Further, in one or more embodiments, the devices can be used to help determine whether a patient will benefit from cardiac resynchronization therapy (CRT). If a patient is a viable candidate for such therapy, then one or more embodiments of the disclosed devices can be used to aid in placement of one or more leads of an implantable medical device and monitor cardiac activity to adjust pacing and sensing parameters of the implanted device.

Currently, bioelectric sensor devices such as vests and belts can be challenging for a clinician to apply to a patient as such devices tend to include somewhat rigid substrates that do not easily conform to the patient's torso. Such devices can be difficult to properly locate on the torso before application as each patient can have a unique anatomy; therefore, greater variability in the design of these devices may be desirable. Further, additional bioelectric sensor devices may need to be kept in inventor to accommodate varying shapes and sizes of patients. And improved cardiac monitoring systems can require additional electrodes disposed in unique locations that current bioelectric sensor devices cannot accommodate.

One or more embodiments of bioelectric sensor devices described herein can provide one or more advantages over current sensor devices. For example, one or more embodiments of devices can include any suitable number of electrodes that are disposed on a flexible substrate that can provide biopotential values for a variety of patient anatomies. Further, one or more embodiments of devices can include a unique design of one or more arms that can increase accuracy of placement of electrodes disposed on the one or more arms while improving patient comfort and motion management of the device as a patient moves while measurements are being taken. The device can, in one or more embodiments, include two or more portions or segments that can be connected after the two or more portions are disposed on the torso of the patient. Further, the device can be rolled-up or folded together in an undeployed configuration and disposed within a smaller package for shipping and storage and then deployed for use.

The various embodiments of bioelectric sensor devices described herein can be utilized with any suitable patient monitoring system. For example, <FIG> is a schematic side view of one embodiment of a patient management system <NUM>. The system <NUM> includes a bioelectric sensor device <NUM>, an imaging apparatus <NUM>, a display apparatus <NUM>, and a computing apparatus <NUM>.

The sensor device <NUM>, which can include any suitable sensor device described herein, is operatively coupled to the computing apparatus <NUM> to provide electrical signals from each of one or more sensors of the sensor device to the computing apparatus <NUM> for analysis.

The imaging apparatus <NUM> can be any type of imaging apparatus adapted to image, or provide images of, at least a portion of the patient in a non-invasive manner. For example, the imaging apparatus <NUM> may not use any components or parts that may be located within the patient to provide images of at least a portion of the patient except non-invasive tools such as contrast solution. It is to be understood that the exemplary systems, methods, and interfaces described herein may noninvasively assist a user (e.g., a physician or clinician) in selecting a location proximate a patient's heart for an implantable electrode, and after the exemplary systems, methods, and interfaces have provided noninvasive assistance, the exemplary systems, methods, and interfaces can then provide assistance to implant, or navigate, an implantable electrode or other device into the patient, e.g., proximate the patient's heart.

For example, after the exemplary systems, methods, and interfaces have provided noninvasive assistance, the exemplary systems, methods, and interfaces may then provide image guided navigation that may be used to navigate leads including electrodes, leadless electrodes, wireless electrodes, catheters, etc., within the patient's body. Further, although the exemplary systems, methods, and interfaces are described herein with reference to a patient's heart, it is to be understood that the exemplary systems, methods, and interfaces may be applicable to any other portion of the patient's body.

The imaging apparatus <NUM> may be configured to capture, or take, x-ray images (e.g., two-dimensional x-ray images, three-dimensional x-ray images, etc.) of a patient <NUM>. The imaging apparatus <NUM> can be operatively coupled (e.g., through one or wired electrical connections, wirelessly, etc.) to the computing apparatus <NUM> such that the images captured by the imaging apparatus <NUM> may be transmitted to the computing apparatus <NUM>. Further, the computing apparatus <NUM> can be adapted to control the imaging apparatus <NUM> to, e.g., adapt the imaging apparatus <NUM> to capture images, change one or more settings of the imaging apparatus <NUM>, etc..

It will be recognized that while the imaging apparatus <NUM> as shown in <FIG> can be adapted to capture x-ray images, any other alternative imaging modality can also be used by the exemplary systems, methods, and interfaces described herein. For example, the imaging apparatus <NUM> may be adapted to capture images, or image data, using isocentric fluoroscopy, bi-plane fluoroscopy, ultrasound, computed tomography (CT), multi-slice computed tomography (MSCT), magnetic resonance imaging (MRI), high frequency ultrasound (HIFU), optical coherence tomography (OCT), intra-vascular ultrasound (IVUS), two dimensional (2D) ultrasound, three dimensional (3D) ultrasound, four dimensional (4D) ultrasound, intraoperative CT, intraoperative MRI, etc. Further, it is to be understood that the imaging apparatus <NUM> can be adapted to capture a plurality of consecutive images (e.g., continuously) to provide video frame data. In other words, a plurality of images taken over time using the imaging apparatus <NUM> may provide motion picture data. Additionally, the images may also be obtained and displayed in two, three, or four dimensions. In more advanced forms, four-dimensional surface rendering of the heart or other regions of the body can also be achieved by incorporating heart data or other soft tissue data from an atlas map or from pre-operative image data captured by MRI, CT, or echocardiography modalities. Image datasets from hybrid modalities, such as positron emission tomography (PET) combined with CT, or single photon emission computer tomography (SPECT) combined with CT, could also provide functional image data superimposed onto anatomical data to be used to confidently reach target locations within the heart or other areas of interest.

The display apparatus <NUM> and the computing apparatus <NUM> can be adapted to display and analyze data such as, e.g., surrogate electrical activation data, image data, mechanical motion data, etc. gathered, or collected, using the sensor device <NUM> and the imaging apparatus <NUM> to noninvasively assist a user in location selection of an implantable electrode. In one or more embodiments, the computing apparatus <NUM> can be a server, a personal computer, a tablet computer, a mobile device such as a smartphone, or an application run by any of these devices. The computing apparatus <NUM> can be adapted to receive input from input apparatus <NUM> and transmit output to the display apparatus <NUM>. Further, the computing apparatus <NUM> may include data storage that can allow for access to processing programs or routines and/or and one or more other types of data, e.g., for driving a graphical user interface configured to noninvasively assist a user in location selection of an implantable electrode, etc..

The computing apparatus <NUM> can be operatively connected to the input apparatus <NUM> and the display apparatus <NUM> to, e.g., transmit data to and from each of the input apparatus <NUM> and the display apparatus <NUM>. For example, the computing apparatus <NUM> can be electrically coupled to each of the input apparatus <NUM> and the display apparatus <NUM> using, e.g., analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, internet-based connections, etc. As described further herein, a user can provide input to the input apparatus <NUM> to manipulate, or modify, one or more graphical depictions displayed on the display apparatus <NUM> to view and/or select one or more target or candidate locations of a portion of a patient's heart as further described herein.

Although as depicted the input apparatus <NUM> is a keyboard, it is to be understood that the input apparatus can include any apparatus capable of providing input to the computing apparatus <NUM> to perform the functionality, methods, and/or logic described herein. For example, the input apparatus <NUM> can include a mouse, a trackball, a touchscreen (e.g., capacitive touchscreen, a resistive touchscreen, a multi-touch touchscreen, a voice-activated screen, etc.), etc. Likewise, the display apparatus <NUM> can include any apparatus capable of displaying information to a user, such as a graphical user interface <NUM> including graphical depictions of anatomy of a patient's heart, images of a patient's heart, graphical depictions of locations of one or more electrodes, graphical depictions of one or more target or candidate locations, alphanumeric representations of one or more values, graphical depictions or actual images of implanted electrodes and/or leads, etc. For example, the display apparatus <NUM> can include a liquid crystal display, an organic light-emitting diode screen, a touchscreen, a cathode ray tube display, etc..

The graphical user interfaces <NUM> displayed by the display apparatus <NUM> can include, or display, one or more regions used to display graphical depictions, to display images, to allow selection of one or more regions or areas of such graphical depictions and images, etc. As used herein, a "region" of a graphical user interface <NUM> can be defined as a portion of the graphical user interface <NUM> within which information may be displayed or functionality may be performed. Regions may exist within other regions, which can be displayed separately or simultaneously. For example, smaller regions may be located within larger regions, regions may be located side-by-side, etc. Additionally, as used herein, an "area" of a graphical user interface <NUM> can be defined as a portion of the graphical user interface <NUM> located with a region that is smaller than the region it is located within.

The processing programs or routines stored and/or executed by the computing apparatus <NUM> can include programs or routines for computational mathematics, matrix mathematics, decomposition algorithms, compression algorithms (e.g., data compression algorithms), calibration algorithms, image construction algorithms, signal processing algorithms (e.g., Fourier transforms, fast Fourier transforms, etc.), standardization algorithms, comparison algorithms, vector mathematics, or any other processing required to implement one or more exemplary methods and/or processes described herein. Data stored and/or used by the computing apparatus <NUM> can include, for example, image data from the imaging apparatus <NUM>, electrical signal data from the sensor device <NUM>, graphics (e.g., graphical elements, icons, buttons, windows, dialogs, pull-down menus, graphic areas, graphic regions, 3D graphics, etc.), graphical user interfaces, results from one or more processing programs or routines employed according to the disclosure herein, or any other data that may be necessary for carrying out the one and/or more processes or methods described herein.

In one or more embodiments, the exemplary systems, methods, and interfaces can be implemented using one or more computer programs executed on programmable computers, such as computers that include, for example, processing capabilities, data storage (e.g., volatile or non-volatile memory and/or storage elements), input devices, and output devices. Program code and/or logic described herein can be applied to input data to perform functionality described herein and generate desired output information. The output information can be applied as input to one or more other devices and/or methods as described herein or as would be applied in a known fashion.

The one or more programs used to implement the systems, methods, and/or interfaces described herein can be provided using any programmable language, e.g., a high-level procedural and/or object orientated programming language that is suitable for communicating with a computer system. Any such programs may, for example, be stored on any suitable device, e.g., a storage media, that is readable by a general or special purpose program running on a computer system (e.g., including processing apparatus) for configuring and operating the computer system when the suitable device is read for performing the procedures described herein. In other words, at least in one embodiment, the exemplary systems, methods, and/or interfaces may be implemented using a computer readable storage medium, configured with a computer program, where the storage medium so configured causes the computer to operate in a specific and predefined manner to perform functions described herein. Further, in at least one embodiment, the exemplary systems, methods, and/or interfaces may be described as being implemented by logic (e.g., object code) encoded in one or more non-transitory media that includes code for execution and, when executed by a processor, is operable to perform operations such as the methods, processes, and/or functionality described herein.

The computing apparatus <NUM> can be, for example, any fixed or mobile computer system (e.g., a controller, a microcontroller, a personal computer, minicomputer, tablet computer, mobile device such as a smartphone, an application installed on any of these devices, etc.). The exact configuration of the computing apparatus <NUM> is not limiting, and essentially any device capable of providing suitable computing capabilities and control capabilities (e.g., graphics processing, etc.) may be used. As described herein, a digital file may be any medium (e.g., volatile or non-volatile memory, a CD-ROM, a punch card, magnetic recordable tape, etc.) containing digital bits (e.g., encoded in binary, trinary, etc.) that may be readable and/or writeable by computing apparatus <NUM> described herein. Also, as described herein, a file in user-readable format may be any representation of data (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, graphically, etc.) presentable on any medium (e.g., paper, a display, etc.) readable and/or understandable by a user.

In view of the above, it will be readily apparent that the functionality as described in one or more embodiments according to the present disclosure may be implemented in any manner as would be known to one skilled in the art. As such, the computer language, the computer system, or any other software/hardware which is to be used to implement the processes described herein shall not be limiting on the scope of the systems, processes or programs (e.g., the functionality provided by such systems, processes or programs) described herein.

As mentioned herein, the patient monitoring system <NUM> can include any suitable bioelectric sensor device <NUM>. For example, <FIG> are various views of one embodiment of a bioelectric sensor device <NUM>. The device <NUM> includes a central portion <NUM> and an arm <NUM> extending from the central portion. At least a portion <NUM> of the arm <NUM> extends along an arm axis <NUM>. The central portion <NUM> includes an anatomical alignment mark <NUM> adapted to align the central portion with an anatomical feature <NUM> (<FIG>) of a lateral surface <NUM> of a torso <NUM> of a patient <NUM>. The arm <NUM> is adapted to be disposed on an anterior surface <NUM> (<FIG>) or posterior surface <NUM> (<FIG>) of the torso <NUM>. The device <NUM> further includes one or more sensors <NUM> disposed on the arm <NUM> along the arm axis <NUM>, and a connector <NUM> electrically connected to the one or more sensors.

In general, the device <NUM> can have any suitable construction. As shown in <FIG>, which is a schematic cross-section view of a portion of the arm <NUM>, the device <NUM> can include a substrate <NUM> that forms at least one of the central portion <NUM> or the arm <NUM>. The substrate <NUM> can be constructed of any suitable material or materials, e.g., polymeric, rubber, natural fiber, etc. In one or more embodiments, the substrate <NUM> can include at least one of polyester (e.g., MYLAR), polyethylene foam, polyester non-woven materials, cellulose rayon non-woven materials, polyethylene vinyl acetate films, polyethylene terephthalate films, thermoplastic polyurethane films, polyimide films, Spandex™, or jacketed ribbon cable. In one or more embodiments, the substrate <NUM> can include a flexible dielectric substrate. The substrate <NUM> can be a single layer or multiple layers of materials. Further, the substrate <NUM> can be transparent, translucent, and/or opaque in one or more areas. In the embodiment illustrated in <FIG>, the substrate includes a first major surface <NUM> and a second major surface <NUM>.

The device <NUM> can, in one or more embodiments, include an adhesive layer <NUM> disposed on the second major surface <NUM> of the substrate <NUM> that faces the torso <NUM> of the patient <NUM> or on one or more electrodes <NUM> (<FIG>) such that the device can be attached to skin of the patient after the device is positioned in the desired location relative to the patient. The adhesive layer <NUM> can include any suitable adhesive, e.g., conductive hydrogels (e.g., polyethylene glycol, etc.), carbon impregnated pressure sensitive adhesive, etc. For example, in one or more embodiments, conductive hydrogels may include cationic acrylates, including, e.g., acrylic esters of quaternary chlorides and/or sulfates or acrylic amides of quaternary chlorides. In one or embodiments, the adhesive layer <NUM> can include a conductive adhesive such that the one or more sensors <NUM> are in electrical contact with the patient <NUM> through the conductive adhesive. Any suitable conductive adhesive can be used for the adhesive layer,.

In one or more embodiments, the adhesive layer <NUM> can include conductive gel disposed on the second major surface <NUM> of the substrate <NUM> and aligned with one or more sensors <NUM> to provide electrical contact between the sensors and skin of the patient <NUM>, and a conductive or non-conductive adhesive disposed on the second major surface to attach the device <NUM> to skin of the patient. The conductive or non-conductive adhesive can be disposed in any suitable pattern on the major surface of the substrate <NUM>, e.g., surrounding areas of conductive gel. In one or more embodiments, the adhesive layer <NUM> is a continuous layer disposed on the second major surface <NUM> of the substrate <NUM>. In one or more embodiments, the adhesive layer <NUM> is discontinuous, e.g., portions or segments of the adhesive layer are aligned with the electrodes <NUM> and not disposed on the remainder of the second major surface <NUM> of the substrate <NUM>.

Further, the device <NUM> can, in one or more embodiments, include a liner <NUM> disposed on the adhesive layer <NUM> such that the adhesive layer is disposed between the substrate <NUM> and the liner. The liner <NUM> can be removed before the device <NUM> is attached to skin of the patient <NUM>. Any suitable liner <NUM> can be utilized, e.g., polymer (e.g., polyethylene, polypropylene), plastic, rubber, natural fiber, polyester, etc. In one or more embodiments, the liner <NUM> can include a paper backing with a coating on one or both sides of the paper, where the coating can include silicone release agents that can provide a differential release. Further, one or more embodiments of liner <NUM> can include indicium, images, etc., that can be utilized by a user for placement of the device <NUM> on the torso <NUM>.

Returning to <FIG>, the central portion <NUM> of the device <NUM> can be a portion of the substrate <NUM> or formed from a different material (e.g., the same materials described herein for the substrate) and connected to the substrate using any suitable technique or techniques. Further, the central portion <NUM> can include any suitable number of layers. The central portion <NUM> of the device <NUM> can take any suitable shape or shapes and have any suitable dimensions. The central portion <NUM> can include a left edge <NUM> and a right edge <NUM>. The arm <NUM> can extend from the left edge <NUM> of the central portion <NUM>.

The central portion <NUM> also includes the anatomical alignment mark <NUM>. The mark <NUM> can be disposed on or within the central portion <NUM> using any suitable technique or techniques, e.g., adhering, printing, embossing, ablating, etc. In one or more embodiments, the mark <NUM> can be disposed on a major surface of the central portion <NUM>. Further, in one or more embodiments, the mark <NUM> can be disposed between two layers of the central portion <NUM>.

The anatomical alignment mark <NUM> can include any suitable indicium, shape, pattern, etc. that is adapted to align the central portion <NUM> with the anatomical feature <NUM> of the patient <NUM>. As shown in <FIG>, the mark <NUM> includes a dashed line that is adapted to align the central portion of the device <NUM> with the anatomical feature <NUM>. In one or more embodiments, the mark <NUM> can include a second indicium, shape, pattern, etc. that is adapted to align the central portion <NUM> with a second anatomical feature. In one or more embodiments, the anatomical alignment mark <NUM> can be adapted to align the central portion <NUM> of the device <NUM> with any suitable number of anatomical features.

Further, the central portion <NUM> can be aligned with any suitable anatomical feature <NUM> of the patient <NUM>. In one or more embodiments, the mark <NUM> can be adapted to align the central portion <NUM> with at least one of the xiphoid, a shoulder blade, or sternum of the torso <NUM>.

Any suitable technique or techniques can be utilized to align the central portion <NUM> with the anatomical feature <NUM>. In one or more embodiments, the anatomical feature <NUM> can be marked with a surgical marker, and the anatomical alignment mark <NUM> can be disposed on the anatomical feature such that the central portion <NUM> is aligned with the anatomical feature. The central portion <NUM> can be connected to the torso <NUM> using any suitable technique or techniques as is further described herein.

Extending from the central portion <NUM> is the arm <NUM>. The arm <NUM> can take any suitable shape or shapes and have any suitable dimension. In one or more embodiments, the arm <NUM> takes a substantially rectilinear shape along the arm axis <NUM>. In one or more embodiments, the arm can take a serpentine shape that oscillates about the arm axis <NUM> as is further described herein. In one or more embodiments, the arm <NUM> can be formed such that it includes one or more accordion folds to accommodate various patient anatomies.

The arm <NUM> is adapted to be disposed on at least one of the anterior <NUM> or posterior <NUM> surface of the torso <NUM>. Further, at least a portion <NUM> of the arm extends along the arm axis <NUM>. In one or more embodiments, the entire arm <NUM> extends along the arm axis <NUM>. Further, in one or more embodiments, a second portion <NUM> of the arm <NUM> does not extend along the arm axis <NUM>.

The arm <NUM> can be integral with the central portion <NUM>, i.e., the arm and the central portion are manufactured as one part. For example, the arm <NUM> can be formed from the substrate <NUM> that forms the central portion <NUM>. In one or more embodiments, the arm <NUM> can be manufactured separately and connected to the central portion <NUM> using any suitable technique or techniques. In one or more embodiments, the arm is connected to the central portion by a fastener <NUM>. The fastener <NUM> can include any suitable fastener, e.g., snaps, adhesives, hook-and-loop fasteners, clips, etc. The arm <NUM> can be held in place on the torso <NUM> using any suitable technique or techniques, e.g., adhesives, hydrogels, wrap-around tension bands connected to the arm, medical-grade tapes, etc..

Disposed on the arm <NUM> are one or more sensors <NUM>. Each sensor <NUM> is adapted to sense bioelectric data when in contact with skin of the patient <NUM>. The sensors <NUM> can be positioned or formed on at least one of the first major surface <NUM> or the second major surface <NUM> of the substrate <NUM>. In one or more embodiments, one or more sensors <NUM> can be disposed on the second major surface <NUM> of the substrate <NUM> such that the sensors are in contact with the skin of the patient <NUM>. In one or more embodiments, the sensors <NUM> can be positioned or formed on the first major surface <NUM> of the substrate <NUM>, and one or more openings or vias can be formed in the substrate that coincide with the sensors such that the sensors can contact skin of the patient <NUM>. In one or more embodiments, one or more of the sensors can be disposed within the substrate <NUM> as shown in <FIG>. The sensors <NUM> can include any suitable sensor that is adapted to sense bioelectric data when in contact with skin of the patient <NUM>. Any suitable number of sensors <NUM> can be disposed on the arm <NUM>. Further, the sensors <NUM> can be disposed in any suitable arrangement on any suitable portion of the arm <NUM>. In one or more embodiments, the sensors <NUM> are disposed on the arm <NUM> along the arm axis <NUM>.

In one or more embodiments, the device <NUM> can be configured such that the sensors <NUM> surround the heart of the patient <NUM> and record, or monitor, the electrical signals associated with the depolarization and repolarization of the heart after the signals have propagated through the torso of the patient. Each of the sensors <NUM> can be used in a unipolar configuration to sense torso surface potentials that reflect the cardiac signals. In one or more embodiments, the sensors <NUM> can be used to evaluate electrical dyssynchrony in the heart of the patient. In such embodiments, the sensors <NUM> can be positioned over the torso <NUM> of the patient <NUM>, including, e.g., the anterior <NUM>, lateral <NUM>, and posterior surfaces <NUM> of the torso <NUM> of the patient <NUM>. A medical monitoring system or apparatus (e.g., apparatus <NUM> of <FIG>) connected to the connector <NUM> of the device <NUM> can record and analyze the torso surface potential signals sensed by the sensors.

The sensors <NUM> can be formed using any suitable technique or techniques. For example, in one or more embodiments, the sensors <NUM> can be formed on the substrate <NUM> using flexographic printing with conductive inks such as Ag, AgCl, copper, Ag flakes in a flexible polymer, etc. In one or more embodiments, the sensors can be formed by chemically etching one or more metals.

The sensors <NUM> can be positioned in any suitable arrangement on the arm <NUM>. As shown in <FIG>, at least one of the sensors <NUM> is disposed on the arm <NUM> along the arm axis <NUM>. Further, one or more of the sensors <NUM> can be removed from the arm <NUM> utilizing any suitable technique or techniques, e.g., the techniques described in co-owned <CIT>, entitled BIOELECTRIC SENSOR DEVICE AND METHODS. Such removal of one or more sensors <NUM> can be utilized to accommodate unique anatomical features of each patient.

The sensors <NUM> can be electrically connected to the connector <NUM> using any suitable technique or techniques. In one or more embodiments, one or more conductors <NUM> can extend from each sensor <NUM> to the connector <NUM>. The connector <NUM> can include one or more contacts, where each contact is electrically connected to a sensor <NUM>. As shown in <FIG>, the conductors <NUM> can be disposed on or within the substrate <NUM>. In one or more embodiments, one or more conductors <NUM> can be disposed on the second major surface <NUM> of the substrate <NUM>. Further, in one or more embodiments, one or more conductors <NUM> can be disposed on the first major surface <NUM>. In one or more embodiments, one or more conductors <NUM> can be disposed on the first major surface <NUM> of the substrate <NUM> and one or more conductors can be disposed on the second major surface <NUM> of the substrate. In one or more embodiments, one or more vias can be formed through the substrate <NUM> to connect a conductor <NUM> disposed on the first major surface <NUM> of the substrate <NUM> or within the substrate to a sensor <NUM> disposed on the second major surface <NUM> of the substrate.

The conductors <NUM> can include any suitable conductive material or materials, e.g., at least one of metal, carbon, or graphite. In one or more embodiments, nanotubes or conductive flakes or particles (e.g., formed of at least one of metal (e.g., Ag, AgCl, copper, Ag flakes disposed in a flexible polymer), carbon, graphite, or other suitable conductive materials) can act as a conductor and be provided within a matrix or carrier. In one or more embodiments, the conductors <NUM> can include an insulating coating that may be provided on or over the conductive material, where the coating can be made from electrically conductive material that can be used as a shielding layer to minimize any interference from unwanted transient signals. And the conductors <NUM> can take any suitable shape or shapes and include any suitable dimensions.

The conductors <NUM> can be formed using any suitable technique or techniques. For example, in one or more embodiments, the conductors <NUM> can be formed on the substrate <NUM> using flexographic printing with conductive inks or chemical etching of metals. In one or more embodiments, one or more conductors <NUM> can be disposed on the first major surface <NUM> of the substrate <NUM> and one or more additional conductors can be disposed on the second major surface <NUM> of the substrate. The conductors <NUM> can be formed in any suitable pattern.

Electrically connected to the sensors <NUM> is the connector <NUM>. The device <NUM> can include any suitable connector or connectors that are adapted to electrically connect the sensors <NUM> to a system such as system <NUM> of <FIG>. The connector <NUM> can be disposed in any suitable relationship relative to the central portion <NUM> and the arm <NUM>. In the embodiment illustrated in <FIG>, the connector <NUM> is connected to the central portion <NUM> of the device <NUM>. As mentioned herein, the connector <NUM> can include one or more contacts, where each contact is electrically connected to a sensor <NUM>.

As mentioned herein, the device <NUM> can include any suitable number of arms that extend from the central portion <NUM> or from another arm. According to the claimed invention, the device <NUM> includes a first arm <NUM>, a second arm <NUM>, a third arm <NUM> and fourth arm <NUM>, the four arms extending from the central portion <NUM>. For example, the device <NUM> includes a second arm <NUM> that extends from the central portion <NUM>. All of the design considerations regarding the first arm <NUM> apply equally to the second arm <NUM>. At least a portion <NUM> of the second arm <NUM> extends along a second arm axis <NUM>. In one or more embodiments, the entire second arm <NUM> extends along the second arm axis <NUM>. Further, in one or more embodiments, a second portion <NUM> of the second arm <NUM> does not extend along the second arm axis <NUM>.

The second arm <NUM> includes one or more sensors <NUM> disposed on or in the second arm along the second arm axis <NUM>. The sensors <NUM> can include any suitable sensor, e.g., the same sensors described herein regarding sensors <NUM>.

The second arm <NUM> can be connected to the central portion <NUM> using any suitable technique or techniques. In one or more embodiments, the second arm <NUM> is integral with the central portion <NUM>. Further, in one or more embodiments, the second arm <NUM> is manufactured separately and connected to the central portion <NUM> using any suitable technique or techniques, e.g., fastener <NUM>.

The second arm <NUM> can extend from the central portion <NUM> in any suitable relationship to the arm <NUM>. In one or more embodiments, the arm axis <NUM> of the arm <NUM> is substantially parallel to the second arm axis <NUM> of the second arm <NUM>. As used herein, the term "substantially parallel" means that an angle formed between two arm axes is less than <NUM> degrees. In one or more embodiments, the arm axis <NUM> of the arm <NUM> and the second arm axis <NUM> of the second arm <NUM> are colinear.

The second arm <NUM> can be disposed on any suitable portion or portions of the torso <NUM> of the patient <NUM>. In one or more embodiments, the arm <NUM> can be adapted to be disposed on the anterior surface <NUM> of the torso <NUM> and the second arm <NUM> can be adapted to be disposed on the posterior surface <NUM> of the torso.

The electrodes <NUM> disposed on or within this second arm <NUM> can be electrically connected to the connector <NUM> using any suitable technique or techniques. In one or more embodiments, each electrode <NUM> of the second arm <NUM> is electrically connected to the connector <NUM> by a conductor <NUM>. Each electrode <NUM> of the second arm <NUM> can be electrically connected to a contact of the connector <NUM> by the conductor <NUM>. In embodiments where the second arm is manufactured separately and then connected to the central portion <NUM>, the second arm <NUM> can include a connector as is further described herein that electrically connects the electrodes <NUM> of the second arm to the connector <NUM> or two a patient monitoring apparatus or system.

In the embodiment illustrated in <FIG>, the device <NUM> includes at least a third arm <NUM> and a fourth arm <NUM>. Each of the third and fourth arms <NUM>, <NUM> extends from the central portion <NUM>. At least a portion <NUM> of the third arm <NUM> extends along the third arm axis <NUM>, and at least a portion <NUM> of the fourth arm <NUM> extends along the fourth arm axis <NUM>. All of the design considerations and possibilities regarding the arm <NUM> apply equally to the third and fourth arms <NUM>, <NUM>.

As shown in <FIG>, one or more sensors <NUM> are disposed on or within the third arm <NUM> along the third arm axis <NUM> and one or more sensors <NUM> are disposed on or within the fourth arm <NUM> along the fourth arm axis <NUM>. Further, each of the third and fourth arms <NUM>, <NUM> can include a connector electrically connected to the respective sensors <NUM>, <NUM> as is further described herein. In one or more embodiments, conductors <NUM> can electrically connect each of the sensors <NUM> of the third arm <NUM> to a contact in the connector <NUM>, and conductors <NUM> can electrically connect each of the sensors <NUM> of the fourth arm <NUM> to a contact in the connector.

The arms <NUM>, <NUM>, <NUM>, and <NUM> of the device <NUM> (collectively arms <NUM>) can extend from the central portion <NUM> in any suitable arrangement relative to each other. For example, in the embodiment illustrate in <FIG>, the arm axis <NUM> of the first arm <NUM> and the third arm axis <NUM> of the third arm <NUM> are substantially parallel. Further, the second arm axis <NUM> of the second arm <NUM> is substantially parallel to the fourth arm axis <NUM> of the fourth arm <NUM>.

Each of the arms <NUM> can be adapted to be disposed on any portion of the torso <NUM> of the patient <NUM>. In one or more embodiments, the arm <NUM> and the third arm <NUM> are adapted to be disposed on the anterior portion <NUM> of the torso <NUM>, and the second arm <NUM> and the fourth arm <NUM> are adapted to be disposed on the posterior portion <NUM> of the torso.

The device <NUM> can further include one or more reference electrodes <NUM>. Any suitable electrode can be utilized for the reference electrodes <NUM>, e.g., the same electrodes described herein disposed on one or more of the arms <NUM>. In one or more embodiments, each reference electrode <NUM> can be disposed on or within a substrate and connected to the torso <NUM> utilizing an adhesive (e.g., adhesive layer <NUM>) such as a conductive adhesive. A liner such as liner <NUM> can be disposed on the adhesive such that the adhesive is disposed between the reference electrode <NUM> and the liner.

Such reference electrodes <NUM> can be disposed in any suitable relationship relative to the central portion <NUM> and arms <NUM> of the device <NUM>. In the embodiment illustrated in <FIG>, the reference electrodes <NUM> are connected to the third and fourth arms <NUM>, <NUM>. The reference electrodes <NUM> can be integral with the second and fourth arms <NUM>, <NUM>, i.e., the substrate <NUM> can in part form the reference electrodes. In one or more embodiments, one or more of the reference electrodes <NUM> can be manufactured separately and connected to the second and fourth arms <NUM>, <NUM> using any suitable technique or techniques. The reference electrodes <NUM> are adapted to be disposed on any suitable portion of the torso <NUM> of the patient <NUM>.

Each of the reference electrodes <NUM> is electrically connected to the connector <NUM> by a conductor <NUM>. In one or more embodiments, each reference electrode <NUM> can be electrically connected to a contact associated with the connector <NUM> by the conductor <NUM>.

One or more embodiments of the device <NUM> can be adapted to be folded or rolled together for packaging. For example, <FIG> is a schematic plan view of the device <NUM> with each arm <NUM> in the undeployed configuration. As shown in <FIG>, each of the arms <NUM> is adapted to be folded or rolled up. In one or more embodiments, one or more retainers <NUM> can be utilized to keep the arms <NUM> in a folded or rolled-up when in the undeployed configuration. When in the undeployed configuration, one or more of the arms <NUM> are folded. In one or more embodiments, one or more of the arms <NUM> are rolled up when in the undeployed configuration The bioelectric sensor device according to the claimed invention comprises a retainer for each of the first, second, third and fourth arm adapted to releasably fix the first, second, third and fourth arm in an undeployed configuration, wherein the first, second, third and fourth arms are folded or rolled up when in the undeployed configuration. The retainer <NUM> can include any suitable fastener, e.g., a strap having a fastening member such as a snap or hook-and-loop fastener, tape, repositionable adhesive tape, buttons, paper clips, rivets, rings, cord locks, hook-and-eye fasteners, magnets, ties, zippers, frog fasteners, etc. The retainer <NUM> can be removed from its respective arm <NUM> such that the arm is in the deployed configuration as shown in <FIG>.

As mentioned herein, the one or more arms of the various embodiments of bioelectric sensor devices can take any suitable shape or shapes. For example, <FIG> is a schematic plan view of another embodiment of a bioelectric sensor device <NUM>. All of the design considerations and possibilities regarding the bioelectric sensor device <NUM> of <FIG> apply equally to the bioelectric sensor device <NUM> of <FIG>.

One difference between the device <NUM> of <FIG> and device <NUM> of <FIG> is that at least a portion <NUM> of one or more of arms <NUM> extends from a central portion <NUM> along an arm axis <NUM> and takes a serpentine shape that oscillates about the arm axis. Such serpentine shape can provide extensibility and flexibility to the arms <NUM> such that an arm or arms can be repositioned along the arm axis <NUM> to accommodate and conform to different sizes of patients. Further, each arm <NUM> includes one or more sensors <NUM> that are disposed on the arm along the arm axis <NUM>. As a result, the sensors <NUM> can remain aligned along the arm axis <NUM> while the arm <NUM> can take the described serpentine shape. Any suitable serpentine shape can be utilized, e.g., a zig-zag (i.e., triangular-wave) shape, a sinusoidal shape, etc. In one or more embodiments, one or more of the arms <NUM> can be formed to include one or more accordion folds such that the arm can be extended to accommodate various patient anatomies.

As is also mentioned herein, one or more arms of the various embodiments of bioelectric sensor devices can be integral with a central portion of the device or can be manufactured separately and then connected to the central portion using any suitable technique or techniques. For example, <FIG> is a schematic plan view of another embodiment of a bioelectric sensor device <NUM>. All of the design considerations and possibilities regarding the bioelectric sensor device <NUM> of <FIG> and the bioelectric sensor device <NUM> of <FIG> apply equally to the device <NUM> of <FIG>.

One difference between device <NUM> and device <NUM> is that device <NUM> includes a first segment <NUM> and a second segment <NUM>. In one or more embodiments, the first and second segments <NUM>, <NUM> can be connected together using any suitable technique or techniques, e.g., adhering, mechanically fastening, etc. In one or more embodiments, a central portion <NUM> of the first segment <NUM> can include a first attachment region <NUM>, and the second segment <NUM> can include a second attachment region <NUM> that is adapted to be connected to the first attachment region. The first and second attachment regions <NUM>, <NUM> can include any suitable attachment mechanisms to connect the first and second portions <NUM>, <NUM>, e.g., the same fasteners described herein regarding <NUM> of <FIG>. In one or more embodiments, at least one of the first attachment region <NUM> and the second attachment region <NUM> can include an adhesive layer such as a repositionable adhesive layer that can connect the first and second segments <NUM>, <NUM>.

Another difference between device <NUM> and device <NUM> is that the first segment <NUM> further includes a first attachment mark <NUM> and the second segment <NUM> includes a second attachment mark <NUM>. The first and second attachment marks <NUM>, <NUM> are adapted to assist a user in aligning the first and second segments <NUM>, <NUM> when being disposed on a torso of a patient and connecting the segments together. Further, the first and second attachment marks <NUM>, <NUM> can be utilized to provide spatial and rotational alignment of the first and second segments <NUM>, <NUM> when being disposed on the torso. The first and second attachment marks <NUM>, <NUM> can include any suitable markings or indicia, e.g., the same markings described herein regarding anatomical alignment mark <NUM> of device <NUM>.

Further, unlike the device <NUM>, the first segment <NUM> of device <NUM> includes a first connector <NUM> and the second segment <NUM> includes a second connector <NUM>. The first and second connectors <NUM>, <NUM> can include any suitable connector or connectors. In one or more embodiments, the first connector <NUM> is adapted to be connected to the second connector <NUM>. In one or more embodiments, the first connector <NUM> is adapted to be connected to a cable or connector of a patient monitoring system, and the second connector <NUM> is adapted to be separately connected to the cable or connector of the system.

The device <NUM> can further include one or more anatomical alignment marks. As shown in <FIG>, the device <NUM> includes a first anatomical alignment mark <NUM> and a second anatomical alignment mark <NUM>. The first and second anatomical alignment marks <NUM>, <NUM> can include any suitable alignment marks, e.g., the same alignment marks described herein regarding anatomical alignment mark <NUM> of device <NUM>. Although depicted as including two alignment marks <NUM>, <NUM>, the device <NUM> can include any suitable number of alignment marks.

The device <NUM> can include any suitable number of segments that are connected utilizing any suitable technique or techniques. For example, <FIG> is a schematic plan view of another embodiment of a bioelectric sensor device <NUM>. All of the design considerations and possibilities regarding the device <NUM> of <FIG>, the device <NUM> of <FIG>, and the device <NUM> of <FIG> apply equally to the device <NUM> of <FIG>.

As shown in <FIG>, the device <NUM> includes a first segment <NUM>, a second segment <NUM>, and a third segment <NUM>. The segments <NUM>, <NUM>, <NUM> can be connected utilizing any suitable technique or techniques, e.g., the same techniques described herein regarding device <NUM> of <FIG>. Further, the device <NUM> can include one or more alignment marks <NUM> that can assist a user in connecting the second and third segments <NUM>, <NUM> to the first segment <NUM>. In one or more embodiments, the alignment marks <NUM> utilized to connect the second segment <NUM> to the first segment <NUM> can be different from the alignment marks utilized to connect the third segment <NUM> to the first segment <NUM>.

One difference between the device <NUM> of <FIG> and the device <NUM> of <FIG> is that the device <NUM> includes multiple connectors <NUM>. In one or more embodiments, the connectors <NUM> can be connected together to provide a single connector that is adapted to be connected to a cable of a patient monitoring system or directly to the patient monitoring system utilizing any suitable technique or techniques. In one or more embodiments, each connector <NUM> can be adapted to connect directly to the cable of the patient monitoring system or to the system without first being connected.

The device <NUM> further includes one or more images <NUM> disposed on one or more of the segments <NUM>, <NUM>, <NUM>. Such images <NUM> can include any suitable images or markings that can assist the user in disposing the segments <NUM>, <NUM>, <NUM> on a torso of a patient. For example, in one or more embodiments, one or more images <NUM> can graphically indicate to the user where a segment of the device <NUM> can be placed on the torso.

Any suitable technique or techniques can be utilized to dispose the various embodiments of bioelectric sensor devices described herein on a torso of a patient. For example, <FIG> is a flowchart of one embodiment of a method <NUM> of disposing the device <NUM> on the torso <NUM> of the patient <NUM>. Although described in regard to the device <NUM>, the method <NUM> can be utilized with any suitable bioelectric sensor device. At <NUM>, the anatomical feature <NUM> on the torso <NUM> can be located utilizing any suitable technique or techniques. In one or more embodiments, the anatomical feature <NUM> can be disposed on the lateral surface <NUM> of the torso <NUM>. The central portion <NUM> of the device <NUM> can be disposed on the lateral surface <NUM> of the torso <NUM> at <NUM> utilizing any suitable technique or techniques such that the anatomical alignment mark <NUM> disposed on the central portion is aligned with the anatomical feature. In one or more embodiments, the central portion <NUM> can be disposed by removing the liner <NUM> from the adhesive layer <NUM> that is disposed on the second major surface <NUM> of the substrate <NUM> of the central portion, and attaching the central portion to the lateral surface <NUM> of the torso <NUM>.

At <NUM>, one or more of the arms <NUM> of the device <NUM> can be manipulated from the undeployed configuration (<FIG>) to the deployed configuration (<FIG>) using any suitable technique or techniques. In one or more embodiments, one or more of the arms <NUM> can be manipulated by removing the retainer <NUM> from the arm and unrolling the arm such that it is in the deployed configuration.

At <NUM>, one or more of the arms <NUM> can be disposed on either the anterior surface <NUM> or posterior surface <NUM> of the torso <NUM> of the patient <NUM> utilizing any suitable technique or techniques. In one or more embodiments, each of the arms <NUM> can be deployed by removing the liner <NUM> from the conductive adhesive layer <NUM> and attaching the arm to either the anterior surface <NUM> or the posterior surface <NUM> of the torso <NUM>.

At <NUM>, one or more of the sensors <NUM>, <NUM>, <NUM>, <NUM> can be electrically connected to a patient monitoring system (e.g., monitoring system <NUM>) utilizing any suitable technique or techniques. For example, the connector <NUM> can be connected to a cable of the monitoring system or directly to the monitoring system.

In one or more embodiments, one or more of the reference electrodes <NUM> can be disposed on a surface of the torso <NUM> utilizing any suitable technique or techniques. For example, a liner can be removed from a conductive adhesive layer disposed on a substrate of the reference electrode <NUM>. The reference electrode <NUM> can be connected to the surface of the torso <NUM> with the conductive adhesive.

Computer-readable media may include computer-readable storage media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

Claim 1:
A bioelectric sensor device (<NUM>) comprising:
a central portion (<NUM>) having a left edge (<NUM>) and a right edge (<NUM>);
a first arm (<NUM>) extending from the left edge (<NUM>) of the central portion, wherein at least a portion (<NUM>) of the first arm extends along a first arm axis (<NUM>), wherein the central portion comprises an anatomical alignment mark (<NUM>) adapted to align the central portion with an anatomical feature (<NUM>) of a lateral surface (<NUM>) of a torso (<NUM>) of a patient (<NUM>), and further wherein the first arm is adapted to be disposed on an anterior (<NUM>) or posterior (<NUM>) surface of the torso;
a sensor (<NUM>) disposed on the first arm along the first arm axis; and
a connector (<NUM>) electrically connected to the sensor
a second arm (<NUM>) extending from the right edge (<NUM>) of the central portion, wherein at least a portion (<NUM>) of the second arm extends along a second arm axis (<NUM>); and
a sensor (<NUM>) disposed on the second arm along the second arm axis and electrically connected to the connector
a third arm (<NUM>) extending from the left edge (<NUM>) of the central portion, wherein at least a portion (<NUM>) of the third arm extends along a third arm axis (<NUM>);
a sensor (<NUM>) disposed on the third arm along the third arm axis and electrically connected to the connector
a fourth arm (<NUM>) extending from the right edge (<NUM>) of the central portion, wherein at least a portion (<NUM>) of the fourth arm extends along a fourth arm axis (<NUM>);
a sensor (<NUM>) disposed on the fourth arm along the fourth arm axis and electrically connected to the connector;
characterized in that the sensor device further comprises:
a retainer for each of the first, second, third and fourth arm adapted to releasably fix the first, second, third and fourth arm in an undeployed configuration, wherein the first, second, third and fourth arms are folded or rolled up when in the undeployed configuration.