EP4287949A1

EP4287949A1 - Screen printed electrodes for an electrocardiogram article

Info

Publication number: EP4287949A1
Application number: EP22750442.0A
Authority: EP
Inventors: Stephen Dunphy; Christain McCLUNG
Original assignee: CB Innovations LLC
Current assignee: CB Innovations LLC
Priority date: 2021-02-08
Filing date: 2022-02-04
Publication date: 2023-12-13
Also published as: WO2022170057A1

Abstract

A wearable diagnostic electrocardiogram (ECG) garment (100) is disclosed herein. The wearable diagnostic ECG garment comprises a garment body (110), screen-printed electrodes (115) positioned on the body (110), and screen-printed wires positioned in the garment body (110), each of the screen-printed wires (105) connected from a central connector module (170) to a screen-printed electrode (115).

Description

Title

Screen Printed Electrodes For An Electrocardiogram Article

(Docket CB 1-023)

Technical Field

The present invention generally relates to ECG devices. Background Art

[0001] The electrocardiogram (ECG) is an essential test that provides medical professionals with essential information in the management of patients with a variety of conditions. It is not only of significant importance in the evaluation and management of patients with chest pain, but also in patients with shortness of breath, syncope, dizziness, seizures, altered mental status, stroke, psychiatric conditions, overdose, palpitations and many other conditions. It is a bulky system with a multitude of wires and connections.

[0002] The ECG provides critical data to the health care provider in managing patients with multiple medical issues. The time to obtain this data is critical and often delayed by the current technology. Minutes can become critical in the patient with an acute myocardial infarction (heart attack).

[0003] Historically, there is training in the interpretation of ECG data, as well as placement of electrodes on the chest of each patient in anatomically specific positions.

[0004] Current ECG placement is done by technicians and providers of varying medical background, including paramedics, health care technicians, nursing assistants, nurses, and doctors. The current technology is bulky, with many wires and cables. The placement of the electrodes in the acquisition of an ECG is specific and requires special training. ECG acquisition is often limited and/or delayed by multiple factors such as body sweat, ability to transport the ECG device into confined areas, performance of concomitant medical procedures such as cardiopulmonary resuscitation (CPR). Because of many limitations, medical providers must make rapid decisions and potentially delay medical care while ECG testing is done. As emergency medicine providers, the inventors have identified a need for more rapid placement of the ECG electrodes, a more portable and manageable system that will not compromise medical care, and the need to eliminate electrode placement errors.

[0005] The acquisition of a 12-lead ECG requires accurate placement of electrodes and avoidance of lead transposition. This has been a challenge for many healthcare workers and staff that place ECG electrodes. For lay persons outside of the healthcare setting this requires expertise not typically expected of the general population. Heart disease is still the number one cause of death in the United States. With an ever-increasing aged population, the timely diagnosis of heart disease and risk stratification is key to improved morbidity and mortality. The 12-lead ECG is central to this diagnosis and management. Technology is enabling extension of the health care continuum to expand into the home and away from a hospital or clinical setting. With a population of educated patients that value time and utility of their health care data, the ability to transmit and interpret reliable ECG data outside of the standard health care setting allows patients to take even more ownership of their health.

Summary Of The Invention

[0006] The motivation for the present invention is to make garments capable of making diagnostic electrocardiogram access to a population both within and outside traditional health care settings, thus enabling a diagnostic quality ECG to be obtained that conforms to American Heart Association guidelines on diagnostic resting ECGs and also capable of obtaining continuous diagnostic ECG monitoring and acquisition during times of exercise and exertion. The device allows for electrode placement in key positions that conform to proximal limb positions and precordial chest positions that allow for a diagnostic-quality ECG to be obtained. Further, the garment allows for this to be applied by both lay persons and medically trained staff. [0007] The present invention incorporates screen-printed ECG electrodes and conducting circuits into a wearable, stretchable, and elastic garment with integrated electrical conducting materials that transfer physiologic electrical signals to a central processing unit for ECG acquisition and interpretation. The garment is available in multiple sizes to accommodate different body types. The garment is reusable, washable, and durable. The device can be used repeatedly by the same user or it can be multi-used between persons with similar sizing constraints.

[0008] The acquisition of a 12-lead ECG requires accurate placement of electrodes and avoidance of lead transposition. This has been a challenge for many healthcare workers and staff that place ECG electrodes. For lay persons outside of the healthcare setting this requires expertise not typically expected of the general population. Heart disease is still the number one cause of death in the United States. With an ever-increasing aging population, the timely diagnosis of heart disease and risk stratification is key to improved morbidity and mortality. The 12-lead ECG is central to this diagnosis and management. Technology is enabling extension of the health care continuum to expand into the home and away from a hospital or clinical setting. With a population of educated patients that value time and utility of their health care data, the ability to transmit and interpret reliable ECG data outside of the standard health care setting allows patients to take even more ownership of their health. The use of ECG-enabled garments also allows this data to be obtained sooner and more reliably among patients presenting to any triage situation, whether that is in the pre-hospital setting or the setting of a crowded emergency room. Smart-garments with multi-sensor monitoring of key vital signs will help to address the dangers in recognizing which triaged patients are experiencing changes in vital signs that may signify more abrupt needs for care and resource allocation.

[0009] A multitude of electrodes and conducting materials is incorporated into a stretchable, elastic garment with indexed positions that meet American Heart Association diagnostic criteria for ECG analysis, and connected to a central unit that transmits acquired electrical signals to an ECG algorithm monitor (with or without signal amplification) via wireless or wired technology to a cloud based data evaluation system and physician confirmed interpretation. By incorporation into a simple garment system it is assured that the electrodes will be placed in the indexed AHA recommended positions across various body types and ensured precise placement and meet diagnostic criteria for resting- and exertion- ECG analysis.

[00010] An Emergency Cardiac and Electrocardiogram (ECG) electrode placement device is a worn device that incorporates elastic electrical conducting materials and elastic material into a pad that is applied to the chest wall placing the electrodes in the appropriate anatomic locations in a rapid, reproducible, reliable fashion. It is provided in a compact, easily stored and transported form that is applied to the chest wall with materials that have adhesive capabilities that resist moisture and conforms to the body with inherent elasticity with placement of electrodes within the pad that maintain proper anatomic ratios and locations. This device remains adherent to the body for specific lengths of time, with examples including adherence for potentially a minimum of 48 hours, yet is easily removable, while tolerating physiologic changes such as sweat or fever or medical treatment, such as CPR. The device is clearly marked and designed to fit to the chest wall so that its application ensures proper placement of all electrodes. The incorporated electrical conducting materials combine together into a single cable/wire that is either directly or indirectly joined to an ECG monitoring device. The cable has adaptor capability that allows for wireless transfer of data to an ECG monitoring device obviating the need for having a bulky ECG machine in close proximity to the patient. The single cable also eliminates the need for multiple wires on a patient. Multiple wires that could potentially interfere with diagnostic imaging such as chest radiographs, or interfere with placement of emergency medical equipment such as transcutaneous cardiac pacer pads or defibrillating pad.

[00011] One aspect of the present invention is a wearable diagnostic electrocardiogram (ECG) garment comprising a garment body and screen- printed electrodes positioned on the body.

[00012] The screen-printed electrodes preferably include concentric ring electrodes, and each of concentric ring electrodes is a bipolar electrode or a tripolar electrode.

[00013] The wearable diagnostic ECG garment also preferably comprises screen-printed wires. Each of the screen -printed electrodes connected to a screen-printed wire. The wearable diagnostic electrocardiogram garment also preferably comprises a central connector module, wherein each of the screen- printed wires is connected to the central connector module. The wearable diagnostic electrocardiogram garment also preferably comprises a wireless transmitter connected to the central connector module. Each of the screen- printed wires and each of the screen-printed electrodes is preferably composed of a screen printable conductive silver. The electrodes are preferably ten electrodes indexed to meet AHA guidelines for diagnostic criteria 12-lead ECG and additional node positions for diagnostic studies for right sided interpretation and posterior interpretation lead positioning.

[00014] Another aspect of the present invention is a wearable diagnostic ECG garment comprising a garment body, screen-printed electrodes positioned on the body, a central connector module, and screen-printed wires on the garment body. Each of the printed wires is connected from the central connector module to an electrode of the screen-printed electrodes.

[00015] Yet another aspect of the present invention is an emergency cardiac and ECG electrode placement device. The device comprises a body and screen-printed electrodes. The body comprise extension members. The body comprises a base layer composed of a flexible material, an adhesive layer composed of a flexible material, and a backing layer attached to an adhesive surface of the adhesive layer. Each of the extension members extend outward from a center of the body for proper placement of the electrodes on a patient.

Brief Description Of The Drawings

[00016] FIG. 1 illustrates a shirt embodiment of the emergency cardiac and ECG electrode device.

[00017] FIG. 1 A illustrates a shirt embodiment of the emergency cardiac and ECG electrode device.

[00018] FIG. 2 illustrates a shirt embodiment of the emergency cardiac and ECG electrode device.

[00019] FIG. 3 is an illustration of an emergency cardiac and ECG electrode device.

[00020] FIG. 4 is an isolated view of a portion of an emergency cardiac and ECG electrode placement device.

[00021] FIG. 5 is an illustration of a multi-electrode screen printed design.

[00022] FIG. 6 is a screen-printed concentric electrode embodiment with an uniaxial strain silver and ecoflex with a stencil coated on the back of the tape.

[00023] FIG. 7 is a screen-printed electrode embodiment with serpentine design.

[00024] FIG. 8 is an illustration of a multi-electrode screen printed design in a serpentine embodiment.

[00025] FIG. 9 is an illustration of screen-printed electrodes V2-V6.

[00026] FIG. 10 is an illustration of screen-printed electrodes.

[00027] FIG. 11 is an illustration of screen-printed electrodes.

[00028] FIG. 12 is an isolated cross-sectional view of an extension and electrode of an emergency cardiac and ECG electrode placement device.

[00029] FIG. 13 is an illustration of a first embodiment of an emergency cardiac and ECG electrode placement device positioned on a patient.

[00030] FIG. 14 is an illustration of a second embodiment of an emergency cardiac and ECG electrode placement device positioned on a patient. [00031] FIG. 15 is an illustration of a third embodiment of an emergency cardiac and ECG electrode placement device with a defibrillation mechanism positioned on a patient.

[00032] FIG. 15A is an illustration of a fourth embodiment of an emergency cardiac and ECG electrode placement device with a defibrillation mechanism positioned on a patient.

[00033] FIG. 15B is an illustration of a fifth embodiment of an emergency cardiac and ECG electrode placement device with a defibrillation mechanism positioned on a patient.

[00034] FIG. 15C is an illustration of a sixth embodiment of an emergency cardiac and ECG electrode placement device with a defibrillation mechanism positioned on a patient.

[00035] FIG. 15D is an illustration of a seventh embodiment of an emergency cardiac and ECG electrode placement device positioned on a patient.

[00036] FIG. 16 is an isolated bottom plan view of a bottom surface of an extension of an emergency cardiac and ECG electrode placement device.

[00037] FIG. 17 is an isolated top plan view of a top surface of an extension of an emergency cardiac and ECG electrode placement device.

[00038] FIG. 18 is a bottom plan view of a multi-electrode screen-printed design.

[00039] FIG. 18A is a top plan view of the embodiment of FIG. 18.

[00040] FIG. 19 is an illustration of a concentric ring electrodes embodiment.

[00041] FIG. 19A is an isolated view of a multipolar electrode of FIG. 19.

Best Mode(s) For Carrying Out The Invention

[00042] As shown in FIGS. 1, 1 A and 2, a wearable diagnostic electrocardiogram (ECG) garment 100 worn by a user 15 comprises a garment body 110, screen-printed electrodes 115, an electrode connector 170, a wireless transmitter 175, and screen-printed wires 105. The screen-printed electrodes 115 VI -V6 are positioned on the body 110. The electrode connector 170 preferably extends from the body 110. The screen-printed wires 105 are positioned in the garment body 110. Each of the wires 105 is connected from the electrode connector 170 to an electrode 115 V1-V6.

[00043] The wearable diagnostic ECG garment 100 preferably also comprises of external electrodes. The garment body 110 of the ECG garment 100 is preferably a long sleeve shirt, a short sleeve shirt or a robe, and is washable. The ECG garment 100 further preferably has a cable management module, sensors, and a wireless transmitter 175.

[00044] The ECG garment 100 is preferably a 12 lead ECG. The screen-printed electrodes 115 are preferably comprised of ten electrodes indexed to meet AHA guidelines for diagnostic criteria 12-lead ECG and additional node positions for diagnostic studies for right sided interpretation and posterior interpretation lead positioning. A diagnostic ECG from the ECG garment 100 conforms to the American Heart Association (AHA) guidelines.

[00045] As shown in FIG. 3, an emergency cardiac and ECG electrode device 20 preferably comprises a body 21 and screen-printed electrodes 115. The body 21 preferably comprises a center extension member 22, a second extension member 23, a third extension member 24, a fourth extension member 25, a fifth extension member 26, a sixth extension member 27, and a seventh extension member 28. Each of the extension members 22-28 extend outward from a center of the body for proper placement of the electrodes 115 on a patient. Each extension member 22-28 preferably has a width ranging from 1cm to 10cm, and a length ranging from 5cm to 20cm. The body 21 further comprises a base layer 30 composed of a flexible material, an adhesive layer 31 composed of a flexible material, and a backing layer 32 attached to an adhesive surface 3 la of the adhesive layer 31.

[00046] In an alternative embodiment, an emergency cardiac and ECG electrode device 20 preferably comprises a body 21, screen-printed electrodes 115, and an electrode connector cable 60 extending from the body 21. The body 21 preferably comprises a center extension member 22, a second extension member 23, a third extension member 24, a fourth extension member 25, a fifth extension member 26, a sixth extension member 27, and a seventh extension member 28. The body 21, as shown in FIG. 12 as a crosssection, further comprises a main layer 30 having a top surface 30a and an adhesive surface 30b, and a backing layer 32 attached to an adhesive surface 31a of the adhesive layer 31. An electrical conducting elastic material is incorporated into the top surface 30a. Each of the screen-printed electrodes 115 are positioned on the adhesive surface 30b of the main layer 30. Each screen-printed electrode 115 is further connected to the electrode connector cable 60 through the electrical conducting elastic material of the main layer 30.

[00047] One preferred material for the flexible material is KT TAPE from Spidertech. The top layer 30 preferably has a Shore A hardness ranging from 50 to 90, which better allows for chest compressions. One preferred material for the adhesive layer is an adhesive from 3M.

[00048] As shown in FIG. 4, a screen-printed wire 60a connects the electrode 50a to the electrode cable connector 71. A screen-printed wire 60b connects the electrode 50b to the electrode cable connector 71. A screen-printed wire 60c connects the screen-printed electrode 50c to the electrode cable connector 71. A screen-printed wire 60d connects the screen-printed electrode 50d to the electrode cable connector 71. A screen-printed wire 60e connects the screen- printed electrode 50e to the electrode cable connector 71. A screen-printed wire 60f connects the screen-printed electrode 50f to the electrode cable connector 71. A screen-printed wire 60g connects the screen-printed electrode 50g to the electrode cable connector 71. A screen-printed wire 60h connects the screen-printed electrode 50h to the electrode cable connector 71. A screen- printed wire 60i connects the screen-printed electrode 50i to the electrode cable connector 71. A printed wire 60j connects the electrode 50j to the electrode cable connector 71. A ten pin electrode interface 75 connects to the electrode cable connector 71. On one embodiment, the elastic electrically conductive material is preferably applied with a 3D printer directly on the main layer.

[00049] Alternatively, an elastic conductive material is substituted for each of the printed wires in FIG. 4. Such elastic conductive materials preferably comprise silver chloride and/or graphene. The body 21 is preferably composed of a kinesiology type tape.

[00050] In FIG. 5 an illustration of a multi-electrode screen printed design is shown.

[00051] FIG. 6 shows a screen printed concentric electrode embodiment with an uniaxial strain silver and ecoflex with a stencil 81 coated on the back of the tape 80. The screen-printed concentric electrodes 115 have a first section 115a and 120b, encompassed by a second section 120a and 125. They are preferably stretchable (30% strain), and adhesive without using conductive gel. The electrodes are fixed on one bandage (to avoid user confusion on lead placement/connection). The electrical shielding for the electrode band preferably shields against high voltage of defibrillator (2500-5000 V, typical current ~20A, biphasic 200J over 10 ms). The wiring design minimizes signal distortion under mechanical strain.

[00052] In FIG. 7, the tape has a width of 5cm (need 5 electrodes for V2-V4 at once). The sacrificial layer 77 is dissolved to allow serpentines to delaminate from the substrate and to be free to buckle upon stretching. The layers comprise of a serpentine backbone layer 74, insulating layers 73, a conductive serpentine layer 76, a sacrificial layer 77, a conductive island layer 78, and an island backbone layer 79.

[00053] In FIG. 8, a backbone is coated on the tape first (using Ecoflex). Wire insulation is preferably of: Dielectric Strength (ASTM D-147-97a): >350 volts/mil. A screen-printed serpentine pattern 120 is created to fit V2-V6 and a stencil is made: The Ecoflex backbone is coated directly on the fabric; measure the maximum resistant and strain; take ECG measurements with these electrodes 115. [00054] FIGS. 9-11, show a serpentine design with lowered resistance.

Execution: Exoflex backbone allowed to stencil electrode on the sticky side 85 of bandage; Less ecoflex to silver ratio also reduced the resistance; evaluate the strain & make measurements with the ECG device. The electrode 115 surface is coated with hydrogel 116 to reduce interfacial resistance. Rearrange the connections and plan for connection to the lead hub (wires instead of clips). The hydrogel 116 is preferably composed of Polyvinyl Alcohol (PVA), Poly(3,4-ethylenedioxythiophene) Polystyrene Sulfonate (PEDOT:PSS) for conductivity.

[00055] As shown in FIG. 13, an EXG device 20 preferably comprises a body 21, electrodes 50, printed wires or an electrical conducting flexible material 60 (not shown), and an electrode cable connector 71. The body 21 preferably comprises a center extension member 22, a first extension member 23, a second extension member 24, a third extension member 25 and a fourth extension member 26. The electrode cable connector 71 is positioned on the body 21. Each extension member 22-26 preferably has a width ranging from 1cm to 10cm, and a length ranging from 5cm to 20cm. The center extension member 22 preferably comprises a first electrode 50a, a second electrode 50b, a third electrode 50c, a fourth electrode 50d, a fifth electrode 50e and a sixth electrode 50f. Screen-printed wires or electrical conducting flexible material 60 (not shown) connect each electrode 50 to the electrode cable connector 71.

[00056] Other embodiments of EXG device 20 are shown in FIGS. 14 and 14A. The extension members extend outward from the center of the body 21.

[00057] Alternative embodiments of the EXG device 20a, shown in FIGS. 15, 15 A, 15B, and 15C, also comprise integrated defibrillation pads 40a and 40b connected to a defibrillation cable 41. In an unstable patient, defibrillation becomes a crucial aspect of emergency cardiac care. The use of defibrillation pads has in the field historically been done with pad placement at the discretion of the first responder/paramedic. The most common deployment being anteriorly. This often leads to suboptimal placement and suboptimal delivery of electricity. The EXG-DF with defibrillator pad assures proper placement of the device in the anterior posterior configuration, which allows for optimal electrical conductance to the heart. The vector of electrical conductance is optimally placed in an anterior posterior configuration. There is no device that provides optimal defibrillator pad placement while integrating twelve lead EKG ability with the ability to extend to include posterior and right sided lead EKG. The ability to obtain instant EKG data after critical defibrillation has heretofore been impractical for the pre-hospital care provider. The EXG-DF addresses this critical issue in cardiac care.

[00058] FIG. 16 illustrates an isolated bottom plan view of a bottom surface of an extension of an EXG device 20. The bottom adhesive surface 30b of the main layer 30 has electrodes 50 positioned thereon.

[00059] FIG. 17 illustrates an isolated top plan view of a top surface of an extension of the EXG device 20. The main layer 30 of the extension has a top layer 30a with integrated printed wires (or elastic electrical conducting material) 60d, 60e and 60f connected to corresponding electrodes 50d, 50e and 50f that are positioned on an adhesive surface below. The electrodes 50d, 50e and 50f are not positioned on the top surface 30a of the main layer 30.

[00060] FIG. 18 illustrates a bottom plan view of a screen-printed electrode 115 embodiment with a serpentine design. An adhesive layer 31 is shown with a piece of the backing layer 32 removed. FIG. 18A illustrates a top plan view of the embodiment.

[00061] FIG. 19 and FIG. 19A illustrate an ECG device 1900 with screen- printed bipolar electrodes 115 embedded into a body 21 at precordial locations. The device 1900 preferably comprises a body 21 and screen-printed bipolar electrodes 115. The body 21 preferably comprises center extension members 26-27 for VI and V2, a third extension member 25, a fourth extension member 24, a fifth extension member 23, and a sixth extension member 22. Each of the extension members 22-27 extend outward from a center of the body for proper placement of the screen-printed electrodes 115 on a patient. Screen-printed wires 120a-120j connect the screen-printed electrodes 115a-l 15j to the central connector module 170.

[00062] Acquisition of electrode signal from skin surface potentials is enhanced with the use of concentric ring electrodes in multipolar format that is also redundant with American Heart Association recommendations for electrode positioning. By utilizing a redundant design of unipolar electrodes 115a in AHA positions and then adding concentric ring electrodes 125, as shown in FIG. 6 and FIG. 19 A, to these same positions we can provide for a LaPlacian electrocardiography; thus allowing for traditional ECG interpretation and enhancing this data with LaPlacian measures that improve the diagnostic performance. These multipolar (bipolar, bipolar, etc) designs enhance the signal quality from the body surface potentials. The EXG system can utilize concentric ring electrodes to capture more detailed electrical activity of the heart and thereby obtain data to that can be used for real-time analysis and further machine learning/artificial intelligence allowing for predictive analytics to be applied for earlier recognition of disease prior to meeting the ECG criteria of those events.

[00063] The ECG device 1900 is preferably provided in a compact, easily storable and transportable form, that is then applied to a patient’s chest wall with materials that have adhesive capabilities that preferably resist moisture and conforms to the patient’s body with inherent elasticity with placement of electrodes within a pad that maintains proper anatomic ratios and locations. The ECG device 1900 preferably remains adherent to the patient’s body through the duration of the acute pre-hospital and transition through the emergency department and acute hospitalization care periods (which is typically three days), but the ECG device 1900 remains easily removable, while tolerating physiologic changes such as sweat, fever, and medical treatment, such as cardiac pulmonary resuscitation (“CPR”). The ECG device 1900 is clearly marked and designed to fit to the chest wall so that its application ensures proper placement of all electrodes on the patient. The incorporated electrical conducting materials come together into a single cable/wire that is either directly or indirectly joined to an ECG monitoring device. The cable has adaptor capability that allows for wireless transfer of data to an ECG monitoring device obviating the need for having a bulky ECG machine in close proximity to the patient. The single cable also eliminates the need for multiple wires on a patient. Multiple wires that could potentially interfere with diagnostic imaging such as chest radiographs, or interfere with placement of emergency medical equipment such as transcutaneous cardiac pacer pads or defibrillating pad.

[00064] The ECG device 1900 reduces the time to perform ECG testing significantly. With proper training, a user can anticipate ECG acquisition in less than one minute, and potentially within seconds. Current ECG data can take several minutes or longer depending on the care setting. It is not unusual for an ECG ordered in a hospital setting to take more than 10-30 minutes.

[00065] The ECG device 1900 also eliminates lead transposition error, which is the attachment of an electrode wire in a wrong electrode.

[00066] The ECG device 1900 makes ECG data more reliable and reproducible. There is no variation in lead placement while performing serial ECGs —which is often done in the hospital and pre-hospital setting. The incorporated elastic electro-conductive materials allow for this small form factor to accommodate varying body types (man, women, adult, child, obese, anorexic) while maintaining strict anatomic ratios and correct placement and ensure proper lead placement.

[00067] The ease of use of the ECG device 1900 makes ECG acquisition less inconvenient and potentially improves ECG utilization in the pre-hospital setting.

[00068] The ECG device 1900 also reduces the frequency of lead detachment. [00069] An alternative embodiment of the EXG system has wireless transfer capability that makes acquisition of the ECG in any situation feasible. [00070] The ECG device 1900 preferably incorporates either integrated elastic electro-conductive materials or printable elastic electro-conductive material used in the acquisition of electrical signals from the electrodes.

[00071] The ECG device 1900 adheres to skin surfaces through a variety of physiologic conditions not currently met by current methods.

[00072] The ECG system allows for acquisition of data in settings that standard methods currently fail.

[00073] Existing technology for ECG acquisition relies on technical expertise in lead placement.

[00074] Removing technical error is dependent of operator knowledge and skill, as well as interpretation of ECG data to identify systemic error in placement.

[00075] The time to acquire an ECG is dependent on many factors but is limited due to the number of electrodes that are placed on the chest and torso, which then need to be attached to the ECG device. There are preferably a minimum of ten wires involved, and more electrodes are possible to allow for more specific views of the right side of the heart and/or posterior heart leads.

[00076] The ECG device 1900 solves the problem of lead detachment, lead reversal, inability to apply leads due to extremes in physiology, and lack of reproducibility to measure subtle changes. The ease of use with EXG allows for acquisition of ECGs that would not have been obtained and therefore limits the opportunity loss of delays in diagnosis and treatment. The use of an elastic pourable or printable or otherwise applied film of elastic conductive material will replace bulky standard cables and wires allowing for a more compact form, smaller footprint, and contribute to less material and weight of the device.

[00077] In one embodiment, the EXG device preferably comprises: adhesive stretchable material that is breathable and water/sweat resistant; embedded elastic electroconductive material conducting electrical signals from the integrated cardiac electrodes to a central data cable; embedded elastic electroconductive material/wiring/cabling arranged to allow for stretching across body types and sizes; electrode connection port; Bluetooth capable emitter and receiver; conduction gel; and embedded electrodes (manufactured or printable).

[00078] The elastic adhesive membrane preferably provides adherence to body surface. It is preferably tolerant to moisture. The ECG device preferably incorporates electroconductive materials and electrodes that conduct signal from the skin to a single data cable/wire. The ECG device preferably expands in an elastic fashion to appropriately fit varied body types while meeting exact ratios of electrode distance without distortion. The ECG device preferably has significant stability of size and shape with elastic components to make it easily applicable to the chest wall. The ECG device preferably comes in a compact form factor.

[00079] In one embodiment, there is encapsulated expandable electroconductive material within the membrane. Within the elastic membrane is incorporated electroconductive materials that originate from each electrode to bring the cardiac electrical signal to the monitoring device via a single data cable encompassing all appropriate ECG leads. This will be a novel use of new technology using elastic electroconductive printable materials that will stretch with the electrode assembly pad and retain conductivity. Potentially use existing electroconductive materials to expand and contract with the device to deliver electrode signals to the monitoring equipment.

[00080] Alternatively, the ECG device allows for the use of external electrodes. In the event that ECG monitoring equipment is not compatible with the data cable, electrodes at the ascribed anatomical locations can be accessed with standard medical cardiac monitoring and ECG devices.

[00081] In one embodiment, there is a conductive membrane at ECG electrode sites. At the ascribed electrode ECG locations is a typical electroconductive Ag/AgCL membrane to conduct current from body surface to ECG monitoring device. [00082] In one embodiment, a data cable brings individual electrodes into one cable that encompasses a minimum of ten wires/leads of the typical ECG analysis which is then compatible with various ECG devices and wireless transfer system. Other conductive interfaces may be utilized with the invention including ones composed of graphene/ carb on, nickel, and copper.

[00083] In use, one applies the ECG device 1900 to an anterior chest wall overlying the sternum symmetrically at a level above the nipple line of the patient and below the sternal notch, removing the backing layer 32 to expose the adhesive surface 3 la of the adhesive layer 31. The precordial limb is then stretched to the lateral chest wall at the mid axillary line below the nipple line. Similarly each limb will have the backing layer 32 removed in succession to expose the adhesive surface 3 la of the adhesive layer 31. The right upper extremity limb is stretched towards the right shoulder. The left upper extremity is stretched towards the left shoulder. The right lower extremity limb is stretched to the right lower abdominal quadrant. The left lower extremity limb is stretched to the left lower abdominal quadrant. The cable is either attached to directly to the ECG device cable. Or in versions utilizing a BLUETOOTH transceiver, then the ECG device 1900 is activated to sync with the BLUETOOTH transceiver that is already connected to the ECG device.

[00084] Another embodiment has a posterior extension member which preferably has multiple electrodes that connect via a cable to an intermediary adapter module which connects to the electrode cable connector. The posterior leads preferably are connected through the adapter module onto the end of the original ECG device 1900 and basically take over leads V5-6 for the standard ECG.

[00085] In an alternative embodiment, the ECG device 1900 comprises a wireless emitter and a wireless receiver. The wireless emitter is connected to electrode cable connector, and the wireless receiver is connected to an ECG machine. The wireless emitter and the wireless receiver preferably operation on a BLUETOOTH communication protocol. However, those skilled in the pertinent art will recognize that other wireless communication protocols may be utilized with the alternative embodiment of the ECG device 1900 without departing from the scope and spirit of the present invention.

[00086] In another embodiment, the ECG device 1900 also preferably comprises a plurality of external electrodes.

[00087] The stretching capability of the extension members of the ECG device 1900 preferably extends from a length LI ranging from 7.0 to 14.0 inches to a length L2 ranging from 10.0 to 16.5 inches. In a most preferred embodiment, LI ranges from 10 to 11 inches, and L2 ranges from 12 to 13 inches. A width of each extension member 22, 23, 24, 25, 26 preferably ranges from

1 centimeter (“cm”) to 10cm, and most preferably 2.5cm to 5cm. A thickness of each extension member 22, 23, 24, 25, 26 preferably ranges from 0.1 inch to 0.5 inch.

[00088] The emergency cardiac and ECG electrode placement device 1900 is capable of being applied to a patient while an emergency vehicle is in motion since the device 20 is applied to and adheres to a patient’s chest area, which mitigates signal loss. Likewise, the emergency cardiac and ECG electrode placement device 1900 is capable of being applied to a patient that is moving due to a seizure, aggressiveness, and the like.

[00089] A preferred source for the printed wires is PE874 conductor ink from Intexar Dupont. Those skilled in the pertinent art will recognize that other printed electrically conductive materials may be used without departing from the scope and spirit of the present invention.

[00090] The ECG device 1900 is a stretchable adhesive fabric utilizing a multitude of electrodes and wires to allow for adjustable sizing within a single device across most adult requirements. This device allows for both nonadhesive and adhesive electrodes to be placed via a re-useable fabric garment that has indexed positioning and capability of being washed for re-use. The garment further allows the attachment of additional physiology monitors such as blood pressure assessment and non-invasive assessment of tissue and capillary oxygenation as well as respiratory variation and pulse oximetry. Often, patients are transported between locations and require bulky monitors to travel with them, whereas this smart-garment allows for compact, within garment, transmission and limits the need for multiple ancillary physical monitors. It also allows for this data to be obtained reliably at home and is pertinent to those patients who would benefit from continued at home telemetry. The device is compatible across a plethora of existing hardware and manufacturers and can be encased in water-proof material to allow for monitoring in austere environments. The device can be sized for infants as well as children and adults. The use of non-adhesive electrodes allows for multiple re-use with greater comfort and improved compliance.

[00091] The specific problem resolved by the present invention is that reliable acquisition of a diagnostic 12 lead ECG within and outside of the traditional health care setting by medically-trained persons as well as laypeople with little training is difficult. The lead positions and the inability to obtain a 12 lead ECG without investing in costly equipment and training make this important medical knowledge inaccessible to most persons unless they are in a traditional health care setting.

[00092] The present invention preferably utilizes adhesive and non-adhesive standard ECG electrodes; shielded and insulated wires for data acquisition and transfer; and stretchable garments made from combined materials such as polyester, spandex, gortex and cotton with strategically placed eyelets that allow for device attachment at specified positions for accurate physiologic monitoring.

[00093] The ECG garments 100 are stretchable elastic fabric types that can be long or short sleeved with extensions down to the proximal limb regions.

[00094] The ECG garment 100 comprises 10 electrode placement nodes, indexed to meet AHA guidelines for diagnostic criteria 12-lead ECG, and additional node positions for diagnostic studies for right sided interpretation and posterior interpretation lead positioning. [00095] The ECG garment 100 comprises conductive materials to transmit electrical signals from the electrodes to a central unit. The central unit receives all electrical signals and can be integrated with wired technology to standard ECG machines for interpretation. The central unit receives all electrical signals from the electrodes and can be integrated with a wireless transmitter for reception by a device such as a cell phone, an ECG machine, or a cloud based system for ECG interpretation.

[00096] The method steps of the invention begin with applying pre-wired garment 100 to anterior chest resting the center chest piece at the marked indication for the nipple line. This assures indexed positioning of the device and alignment with the precordial positions. Next, stretch the garment so it rests at least to the level just distal to the hip joint at the lower limbs and distal to the shoulder joint at the proximal limbs. Stretching the garment to the proximal limb positions having prior adequate precordial positions now satisfies the AHA guidelines for diagnostic resting ECG interpretation. Next, the left sided electrode should rest at the mid axillary line and below the nipple level when lying down. This ensures adequate lateral positioning of the device. The device can be further secured for external activity by looping a connection around the torso, neck and proximal limbs. Securing the device to the torso and limbs allows for continued monitoring during movement and/or exertion and limits the single noise induced with shifting lead positions. A modified version is incorporated into a long shirt like garment. A mother modified version includes an inner stretchable fabrics layer as described above that is conformable while an outer loose layer of cotton forms a gown typical of hospital use with closures at the neck and sides or directly with a multitude of enclosures such as tooth-in-groove binding or stud-eyelet-groove attachments.

[00097] The electrodes include a multitude of designed electrodes to improve signal to noise ratio through use of designs which limit wire movement and improved signal processing from skin electrodes which are designed with bipolar and bipolar concentric ring electrodes. These electrodes are flexible and elastic with improved spatial resolution. They are printable by methods of screen printing and methods of 3D printing directly to fabric. The design of the interface between the electrode and the lead is optioned to allow for exchange/replacement of electrodes which offers re-useability. The flexible electronic composition allows for conformity to various body habitus while preserving the integrity of signal quality at rest and in motion.

[00098] The skin-to-electrode interface preferably is comprised of either AgCl printed gel, graphene, or copper with overlying AgCl.

[00099] In one embodiment, metallic electrodes are specifically designed to be covered with re-placeable AgCl covers. This allows for insertion into spaces within the fabric for improved positioning, hold, and removability which allows re-use.

[000100] In one embodiment, a printable electrode design demonstrates an interface between the leads and the electronic components for taking the analog data and passing through either an analog connector directly to a bedside traditional ECG instrument or the option of wireless transmission with an analog-to-digital transmitter with a reciprocating receiver for connectivity to instruments or cloud-based ECG analysis.

[000101] In one embodiment is a modular design of printable electrodes and fabric limbs with a central chest piece for index anatomical positioning and central attachment of leads for signal transmission/connection. This modular design allows for ECG analysis with traditional 12-lead, 15 Lead, Right-sided lead positions, and posterior lead positions which encompasses the totality of acute diagnostic lead positioning in acute care.

[000102] The ECG garment as a robe/gown will have velcro-like pulleys for compression positioning of the electrodes against the proximal limbs and across the chest and will afford various height adjustments and adjustments for girth. [000103] Using the ECG garment 100 will reduce the time to complete an electrocardiogram (ECG) in the pre-hospital and emergency setting, eliminate systematic error in placement and interpretation of an ECG electrode, maintain and place electrodes in the proper anatomic locations across all body types, will not delay management in critical case, maintain proper skin contact through different physiologic responses such as sweat, cold and heat, as well as through medical treatment such as CPR, be easy to train providers in application and placement of ECG electrodes, and be adaptable to scenarios where space and situations limit ECG placement.

[000104] Components for the invention include the following. Standardized physiologic electrodes (carbon-based, Silver-based, gold-based, Nickel-based or steel-based). Standardized wires with surrounding insulation and shielding which reduces nearby electrical interference and provides adequate protection. Adhesives or ergonomic garments that ensure reliable application of the electrodes to the skin surface. Wired connection between the electrode/wire coupling and an interpretive device (ECG machine). Standardized wireless transmitters and receivers that allow for analog to digital and digital to analog conversions to be used with ECG machines or cloud based machine analysis. Artificial Intelligence engines that provides machine and deep learning methodology to apply a multitude of ECG analysis repeatedly to individuals and groups. Computer data centers as repositories for data collected from ECG devices. Applications on internet connected smart phones that link to blue tooth and other wireless transmitters to integrate signal and data processing to the computer and cloud based data centers.

[000105] An electrode allows for the acquisition of superficial electrical activity.

[000106] A wireless electrode interface carries the electrical activity to a transmitter or device directly.

[000107] A powered transmitter is a long-life Battery Powered Wireless analog- to-analog or analog-to-digital transmission with or without amplification, or alternatively a direct powered connection between transmitter and receiver with or without amplification through a direct machine connection.

[000108] A powered receiver is a long-life Battery Powered Wireless analog-to- analog or digital-analog receiver with or without amplification.

[000109] A direct wired connector is a wire to ECG machine interface, multi-pin connector with or without amplification.

[000110] An ECG analytic device is a Cloud based or direct machine based instrument to interpret and allow display of the above data for analysis.

[000111] A stretchable garment with adaptive interface for varied electrode positioning is a stretchable and durable fabric to allow for adequate apposition of electrode to skin with appropriate integrity and indexed positioning. Also afford an interface for the wires and electrode to allow removal and reuse which affords appropriate hygiene and durability of the modular components.

[000112] Indexed center chest piece for wire management is the center chest piece allows for variable wire length and positioning to afford individualized electrode placement with a standard set of wire lengths. The chest piece is indexed to the center of the chest and the resting nipple line. Correct anatomical indexing assures the diagnostic positioning of the electrodes.

[000113] A conductive elastic rubber material is disclosed in U.S. Patent Number 8491884. A stretchable graphene film material is disclosed in Chen et al., U.S. Patent Publication Number 20150273737. A flexible conductive material comprising silver is disclosed in Taguchi et al., U.S. Patent Publication Number 20130056249.

Claims

1. A wearable diagnostic electrocardiogram (ECG) garment comprising: a garment body; a plurality of screen-printed electrodes positioned on the body.

2. The wearable diagnostic electrocardiogram garment according to claim 1 wherein the plurality of screen-printed electrodes comprises a plurality of concentric ring electrodes.

3. The wearable diagnostic electrocardiogram garment according to claim 2 further comprising a plurality of screen-printed wires, each of the plurality of screen- printed electrodes connected to a screen-printed wire of the plurality of screen-printed wires.

4. The wearable diagnostic electrocardiogram garment according to claim 1 wherein each of plurality of concentric ring electrodes is a bipolar electrode or a tripolar electrode.

5. The wearable diagnostic electrocardiogram garment according to claim 3 further comprising a central connector module, wherein each of the plurality of screen-printed wires is connected to the central connector module.

6. The wearable diagnostic electrocardiogram garment according to claim 5 further comprising a wireless transmitter connected to the central connector module.

7. The wearable diagnostic electrocardiogram garment according to claim 1 wherein the wearable diagnostic electrocardiogram garment is a 12 lead ECG.

8. The wearable diagnostic electrocardiogram garment according to claim 1 wherein each of the plurality of screen-printed wires and each of the screen-printed electrodes is composed of a screen printable conductive silver.

9. The wearable diagnostic electrocardiogram garment according to claim 1 wherein the plurality of electrodes is ten electrodes indexed to meet AHA guidelines for diagnostic criteria 12-lead ECG and additional node positions for diagnostic studies for right sided interpretation and posterior interpretation lead positioning.

10. A wearable diagnostic electrocardiogram (ECG) garment comprising: a garment body; a plurality of screen-printed electrodes positioned on the body; a central connector module; a plurality of screen-printed wires on the garment body, each of the plurality of printed wires connected from the central connector module to an electrode of the plurality of screen-printed electrodes.

11. The wearable diagnostic electrocardiogram garment according to claim 10 wherein each of the plurality of screen-printed wires and each of the screen-printed electrodes is composed of a screen printable conductive silver.

12. The wearable diagnostic electrocardiogram garment according to claim 10 further comprising a wireless transmitter connected to the central connector module.

13. The wearable diagnostic electrocardiogram garment according to claim 10 wherein the plurality of screen-printed electrodes comprises a plurality of concentric ring electrodes.

14. The wearable diagnostic electrocardiogram garment according to claim 13 wherein each of plurality of concentric ring electrodes is a bipolar electrode or a tripolar electrode.

15. An emergency cardiac and electrocardiogram (ECG) electrode placement device, the device comprising: a body comprising a plurality of extension members, wherein the body comprises a base layer composed of a flexible material, an adhesive layer composed of a flexible material, and a backing layer attached to an adhesive surface of the adhesive layer; and a plurality of screen-printed electrodes; wherein each of the plurality of extension members extend outward from a center of the body for proper placement of the plurality of electrodes on a patient.

16. The emergency cardiac and ECG electrode placement device according to claim 15 further comprising a plurality of screen-printed wires, each of the plurality of screen-printed electrodes connected to a screen-printed wire of the plurality of screen- printed wires.

17. The emergency cardiac and ECG electrode placement device according to claim 15 further comprising a central connector module, wherein each of the plurality of screen-printed wires is connected to the central connector module.

18. The emergency cardiac and ECG electrode placement device according to claim 17 further comprising a wireless transmitter connected to the central connector module.

19. The emergency cardiac and ECG electrode placement device according to claim 15 wherein each of the plurality of screen-printed wires and each of the screen- printed electrodes is composed of a screen printable conductive silver.

20. The emergency cardiac and ECG electrode placement device according to claim 15 wherein the plurality of screen-printed electrodes comprises a plurality of concentric ring electrodes.

21. The emergency cardiac and ECG electrode placement device according to claim 20 wherein each of plurality of concentric ring electrodes is a bipolar electrode or a tripolar electrode.