Defibrillator electrode assembly and device, method, and system for reducing impedance

Abstract

A defibrillator system is configured to reduce impedance when applied to a patient. The system has a defibrillator electrode; a differential pressure barrier coupled to the defibrillator electrode and at least partially defining a space adjacent the defibrillator electrode; a coupling surface configured for coupling the differential pressure barrier relative to the patient such that the space is contained in a chamber adjacent the defibrillator electrode; and a source of differential pressure associated with the chamber to create positive or negative pressure in the chamber. In this way, the defibrillator system is configured to reduce the impedance when the positive or negative pressure is created (e.g. when the fluid in the chamber is at a pressure and / or as a vacuum is created in the space) in the chamber to urge the defibrillator electrode toward the patient when the defibrillator system is applied to the patient.

Description

[0001] DEFIBRILLATOR ELECTRODE ASSEMBLY AND DEVICE, METHOD, AND SYSTEM FOR

[0002] REDUCING IMPEDANCE

[0003] CROSS REFERENCE TO RELATED APPLICATIONS

[0004] This application claims priority to U.S. Provisional Patent Application No. 63 / 543,256, filed on October 9, 2023, titled "DEVICE AND METHOD FOR REDUCING THE IMPEDANCE OF DEFIBRILLATOR PAD ELECTRODES," U.S. Provisional Patent Application No. 63 / 593,102, filed on October 25, 2023, titled "DEVICE AND METHOD FOR REDUCING THE IMPEDANCE OF DEFIBRILLATOR PAD ELECTRODES," and U.S. Provisional Patent Application No. 63 / 551,909, filed on February 9, 2024, titled "DEVICE AND METHOD FOR REDUCING THE IMPEDANCE OF ELECTRODES INCLUDING DEFIBRILLATOR PAD ELECTRODES," the entireties of each of which are incorporated by reference herein for all purposes.

[0005] BACKGROUND OF THE INVENTION

[0006] Prior defibrillation electrodes generally took the form of paddles that were pressed against the patient's body by hand. More recently, it has become more common to employ gel pad electrodes which are adhesively attached to the patient. Nevertheless, there remains a need for a device and method for improving defibrillators, defibrillator pads, and defibrillator pad electrodes in terms of performance, reliability, cost, efficacy, and / or ease of use.

[0007] SUMMARY OF THE INVENTION

[0008] According to a first aspect of the present invention, a defibrillator electrode assembly is configured to reduce impedance when the defibrillator electrode assembly is applied to a patient. The defibrillator electrode assembly has a defibrillator electrode, a vacuum barrier coupled to the defibrillator electrode, and a sealing surface associated with the vacuum barrier. The vacuum barrier at least partially defines a space adjacent the defibrillator electrode. The sealing surface is configured for coupling the vacuum barrier relative to the patient such that when the vacuum barrier is coupled relative to the patient, the vacuum barrier is configured to create at least one chamber when coupled to the patient and to resist the flow of fluid into or out from the chamber. The defibrillator electrode assembly is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient.

[0009] According to another aspect of the present invention, a defibrillator electrode assembly is configured to reduce impedance when the defibrillator electrode assembly is applied to a patient. The defibrillator electrode assembly has a defibrillator electrode, at least one chamber adjacent the defibrillator electrode, and a coupling surface. The at least one chamber is configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure. The coupling surface includes an adhesive configured for directly or indirectly coupling the at least one chamber relative to the patient. The defibrillator electrode assembly is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient and the fluid in the chamber is at the pressure.

[0010] According to still another aspect of the present invention, a device is configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient. The device has a vacuum barrier and a sealing surface associated with the vacuum barrier. The vacuum barrier is configured to at least partially define a space adjacent the defibrillator electrode pad when the vacuum barrier is coupled to at least one of the defibrillator electrode pad and the patient. The sealing surface is configured for coupling the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient and to resist the flow of the fluid into or out from the space when the vacuum barrier is coupled relative to at least one of the defibrillator electrode pad and the patient. The device is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the sealing surface of the device couples the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the space is at the vacuum.

[0011] According to yet another aspect of the present invention, a device is configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient. The device has at least one chamber configured to be positioned adjacent the defibrillator electrode pad and a coupling surface. The at least one chamber is configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure. The coupling surface is configured for positioning the at least one chamber relative to at least one of the defibrillator electrode pad and the patient. The device is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the coupling surface of the device positions the at least one chamber relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the at least one chamber is at the pressure.

[0012] According to another aspect of the present invention, a method is provided for configuring a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient. The method includes steps of positioning a differential pressure barrier adjacent the defibrillator electrode pad to at least partially define a space adjacent the defibrillator electrode pad, adhering the defibrillator electrode pad on the patient, and forming a chamber to resist the flow of a fluid into or out from the space. The step of adhering the defibrillator electrode pad on the patient is performed before or after positioning the differential pressure barrier adjacent the defibrillator electrode pad. The step of forming a chamber to resist the flow of a fluid into or out from the space is performed such that the impedance can be reduced as positive or negative pressure of the fluid in the chamber urges the defibrillator electrode pad toward the patient when the fluid in the chamber is at the positive or negative pressure. Once the desired reduced impedance is achieved, optionally, the differential pressure may be released.

[0013] According to still another aspect of the present invention, a method is provided for reducing impedance when a defibrillator electrode assembly is applied to a patient. The method includes steps of applying the defibrillator electrode assembly to a patient, increasing or decreasing the pressure in a chamber positioned between a differential pressure barrier and a defibrillator electrode of the defibrillator electrode assembly, and reducing the impedance as positive or negative pressure in the chamber urges the defibrillator electrode toward the patient when fluid in the chamber is at the positive or negative pressure. Once the desired reduced impedance is achieved, optionally, the differential pressure may be released.

[0014] According to yet another aspect of the present invention, a defibrillator system is configured to reduce impedance when applied to a patient. The defibrillator system has a defibrillator electrode, a differential pressure barrier coupled to the defibrillator electrode, a coupling surface associated with the differential pressure barrier, and a source of differential pressure associated with the chamber to create positive or negative pressure in the chamber. The differential pressure barrier at least partially defines a space adjacent the defibrillator electrode. The coupling surface is configured for coupling the differential pressure barrier relative to the patient such that the space is contained in a chamber adjacent the defibrillator electrode. The defibrillator system is configured to reduce the impedance when the positive or negative pressure is created in the chamber to urge the defibrillator electrode toward the patient when the defibrillator system is applied to the patient.

[0015] According to yet another aspect of the present invention, a method for reducing transthoracic impedance associated with treating or diagnosing a cardiac arrhythmia in a patient is provided. The method includes steps of adhering or sealing a defibrillator electrode assembly to the skin of a patient such that a defibrillator electrode of the defibrillator electrode assembly is interposed between the skin of the patient and a differential pressure barrier of the defibrillator electrode assembly; applying a pressure differential to a space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly; urging the defibrillator electrode of the defibrillator electrode assembly into improved contact with the skin of the patient, thereby reducing the transthoracic impedance; and treating or diagnosing the cardiac arrhythmia in the patient after or concurrently with applying the pressure differential to the space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly.

[0016] BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The above and other aspects and features of the present invention will become more apparent to those of ordinary skill in the art by describing in detail exemplary embodiments thereof with reference to the attached drawings.

[0018] FIG. 1 depicts an exemplary embodiment of defibrillator pads as positioned on a patient;

[0019] FIG. 2 depicts a cross-section view of an exemplary embodiment of a device in which a vacuum urges the electrode toward the patient in accordance with aspects of the invention;

[0020] FIG. 3A depicts a bottom view of another exemplary embodiment of a defibrillator pad revealing a heating element in accordance with aspects of the invention;

[0021] FIG. 3B depicts a cross-section view of the defibrillator pad of FIG. 3A taken along line 3B-3B;

[0022] FIG. 4A depicts a top view of another exemplary embodiment of a defibrillator pad assembly in accordance with aspects of the invention;

[0023] FIG. 4B depicts a bottom view of the defibrillator pad assembly of FIG. 4A.

[0024] FIG. 5 depicts a bottom view of another exemplary embodiment of a defibrillator pad in accordance with aspects of the invention;

[0025] FIG. 6 depicts a bottom view of another exemplary embodiment of a defibrillator pad in accordance with aspects of the invention;

[0026] FIG. 7 depicts an exemplary embodiment of a source of differential pressure or an exemplary embodiment of a vacuum unit;

[0027] FIG. 8 depicts another exemplary embodiment of a vacuum unit in accordance with aspects of the invention;

[0028] FIG. 9A depicts an exemplary embodiment of a defibrillator pad as positioned on a patient; FIG. 9B depicts an exemplary embodiment of a device in accordance with aspects of the invention;

[0029] FIG. 9C depicts a cross-section view of the device shown in FIG. 9B;

[0030] FIGS. 10A-10C depict an exemplary embodiment of an overlay configured to at least partially cover the defibrillator electrode pad in accordance with aspects of the invention;

[0031] FIG. 11A depicts a cross-section view of an exemplary embodiment of a device in accordance with aspects of the invention;

[0032] FIG. 11B depicts a cross-section view of another exemplary embodiment of a device in accordance with aspects of the invention;

[0033] FIG. 12 depicts a cross-section view of an exemplary embodiment of a defibrillator electrode assembly in accordance with aspects of the invention;

[0034] FIG. 13 depicts a cross-section view of another exemplary embodiment of a defibrillator system in accordance with aspects of the invention;

[0035] FIG. 14A depicts a bottom view of an exemplary embodiment of a defibrillator system in accordance with aspects of the invention;

[0036] FIG. 14B depicts a cross-section view of the defibrillator system of FIG. 14A in accordance with aspects of the invention;

[0037] FIG. 15A depicts a bottom view of yet another exemplary embodiment of a defibrillator pad assembly showing a plurality of chambers in accordance with aspects of the invention;

[0038] FIG. 15B depicts a cross-section view of the defibrillator pad assembly of FIG. 15A, taken along line 15B-15B;

[0039] FIG. 16A depicts a top view of another exemplary embodiment of segmented chambers in fluid communication with each other in accordance with aspects of the invention;

[0040] FIG. 16B depicts a top view of yet another exemplary embodiment of segmented chambers in fluid communication with each other in accordance with aspects of the invention;

[0041] FIG. 17 depicts a top view of the defibrillator pad assembly of FIG. 16B as applied to conform to a patient anatomy in accordance with aspects of the invention;

[0042] FIGS. 18A-18B depict non-limiting types of exemplary distribution media in accordance with aspects of the invention;

[0043] FIG. 19A depicts a defibrillator paddle showing baffles in accordance with aspects of the invention;

[0044] FIG. 19B depicts a cross-section view of the defibrillator paddle of FIG. 19A; FIG. 20 depicts a cross-section view of an exemplary defibrillator pad assembly in accordance with aspects of the invention;

[0045] FIG. 21A depicts a schematic graph illustrating impedance reduction as vacuum is introduced in accordance with testing of the exemplary defibrillator pad assembly of FIG. 24;

[0046] FIG. 21B depicts another graph showing impedance reduction as vacuum is introduced in accordance with testing of the exemplary defibrillator pad assembly of FIG. 24;

[0047] FIGS. 22-23 depict a cross-section view and a side view, respectively of another exemplary embodiment of a device in accordance with aspects of the invention;

[0048] FIG. 24 depicts an exploded view of an exemplary embodiment of a defibrillator electrode assembly configured to reduce impedance when the defibrillator electrode assembly is applied to a patient in accordance with aspects of the invention;

[0049] FIG. 25 depicts an exploded view of an exemplary embodiment of a device configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient in accordance with aspects of the invention;

[0050] FIG. 26 depicts an exploded view of an exemplary embodiment of a defibrillator electrode assembly configured to reduce impedance when the defibrillator electrode assembly is applied to a patient in accordance with aspects of the invention; and

[0051] FIG. 27 depicts an exploded view of an exemplary embodiment of a device configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient in accordance with aspects of the invention;

[0052] FIG. 28 depicts an exemplary method for configuring a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient in accordance with aspects of the invention;

[0053] FIG. 29 depicts an exemplary method for reducing impedance when a defibrillator electrode assembly is applied to a patient in accordance with aspects of the invention; and

[0054] FIG. 30 depicts an exploded view of an exemplary embodiment of a device configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient in accordance with aspects of the invention. DETAILED DESCRIPTION OF THE INVENTION

[0055] Although the invention is illustrated and described herein with reference to specific embodiments, the invention is not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the invention.

[0056] Additionally, various forms and embodiments of the invention are illustrated in the figures. It will be appreciated that the combination and arrangement of some or all features of any of the embodiments with other embodiments is specifically contemplated herein. Accordingly, this detailed disclosure expressly includes the specific embodiments illustrated herein, combinations and sub-combinations of features of the illustrated embodiments, and variations of the illustrated embodiments.

[0057] In the following detailed description, numerous specific details are set forth by way of examples in order to provide a thorough understanding of the relevant design features. However, it should be apparent to those skilled in the art that the present design features may be practiced without such details. In other instances, well known methods, procedures, components, and circuitry have been described at a relatively high-level, without detail, in order to avoid unnecessarily obscuring aspects of the present design. For example, use of at least one electrode which adheres to a subject for applying treatment in the form of an electric shock, for example, to defibril late or pace the subject, would be known by one skilled the art, as described, for example, in U.S. Pat. No. 9,162,045 titled "Biomedical electrode," which is incorporated herein by reference.

[0058] Various terms are used throughout the disclosure to describe the physical shape or arrangement of features. In the description, relative terms such as "horizontal," "vertical," "inner," "outer," "up," "down," "top" and "bottom" as well as derivatives thereof (e.g., "horizontally," "downwardly," "upwardly," etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms concerning attachments, coupling and the like, such as "connection," "coupled," "adhered," "mounted," "connected" and "interconnected," refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise.

[0059] Finally, the terms "patient" or "subject" as used herein generally refer to recipients of diagnosis, monitoring, and treatment of cardiac arrythmias (e.g. defibrillation to treat a myocardial infarction or cardiac arrest, etc.) via defibrillation, cardioversion, pacing, ECG, and other like procedures. The terms "user" or "clinician" as used herein generally refer to the deliverer or practitioner of diagnosis, monitoring, and treatment of cardiac arrythmias (e.g. defibrillation to treat a myocardial infarction or cardiac arrest, etc.) via defibrillation, cardioversion, pacing, ECG, and other like procedures. However, one skilled in the art would understand from the description herein that the devices, methods, and systems disclosed herein may also be suitable for care and management of a variety of medical situations involving cardiac arrythmias and are not limited to any particular situation disclosed herein.

[0060] Generally, this invention makes it possible to improve the diagnosis, monitoring, and treatment of cardiac arrythmias such as by defibrillation, cardioversion, pacing, ECG, and other procedures.

[0061] External defibrillators and cardioversion machines are used for diagnosing and treating cardiac arrythmias. They may use self-adhesive electrode pads. It has been discovered that, depending on the quality of the adhesive pad, patient anatomy, and / or the application of the pad to a patient, suboptimal electrode performance may result. Typical initial energy levels for biphasic defibrillators range between 120 and 200 joules. For monophasic defibrillators, the initial energy level for adults is usually 360 joule. Poor coupling (e.g., contact) of the electrode to the patient can result in higher electrical impedance. This in turn can result in suboptimal performance during defibrillation and / or cardioversion as the energy is less effectively directed to the heart. A patient may need to be shocked more than once or repeatedly to achieve desired results. Defibrillation to treat a myocardial infarction or cardiac arrest may be unsuccessful. A patient that might have otherwise undergone successful cardioversion may end up being admitted to the hospital. Higher than optimal impedance, as well as repeated shock, can also result in skin burns which are painful to the patient and require further medical attention. Better control of the coupling between the electrode pad and the patient can also result in lower skin irritation and burns. Aspects of the present invention can also be employed in conventional electrode paddles as well. In the case of Automated External Defibrillators (AEDs), any member of the public may apply the defibrillator electrode pads. Aspects of this invention enhance the defibrillator pad performance and make it easier for the average person to achieve good electrode performance. The active electrode to patient coupling enhancement ensures that excellent electrode to patient coupling is achieved with minimal user skill, training, or attention to good practices. For the purposes of the invention described herein, the term defibrillation may be used interchangeably with cardioversion and other procedures for diagnosing or treating cardiac arrythmias. According to aspects of this invention, lower impedance can avoid or at least reduce the foregoing problems. Reduced impedance has the potential to improve outcomes and save lives.

[0062] The device described herein enhances the contact between the defibrillator electrode pad and a patient. It reduces the impedance during defibrillation and cardioversion. The device may be applied to at least one defibrillator pad or can be integrated into at least one defibrillator pad.

[0063] According to one aspect of the invention, a system is provided for coupling or attaching the device to the patient and to increase the contact pressure between the defibrillator electrode and the patient. The device intensifies the contact pressure between the electrode and a patient. In preferred embodiments, the device is an interface pressure intensifier. This is accomplished by a differential in pressure which results in increased contact pressure at the electrode to patient interface. Differential pressure can be achieved through the application of pressure, vacuum, or a combination of both. Vacuum is considered anything less than atmospheric pressure (1 bar or about 14.7 psi). Positive pressure is anything greater than atmospheric pressure. Herein, the pressure at sea level is referred to as 0 psi (0 psi gauge). The minimum pressure attainable is ~14.7 psi of vacuum (-14.7 psi gauge). For example, a vacuum of 0.25 psi is a negative pressure of -0.25 psi gauge.

[0064] A method for employing the device is also provided. In one embodiment, the device uses a vacuum to generate the enhanced contact pressure at the interface between the electrode and the patient. In another embodiment, pressure is generated in the device to enhance interface contact pressure.

[0065] In a further embodiment, a combination of vacuum and pressure is used to increase the interface contact pressure. For example, in embodiments where positive pressure and vacuum are combined, the pressure can be applied to the vacuum seal to improve the seal effectiveness. The combination of pressure and vacuum can be used to increase the available contact interface pressure. Combining pressure and vacuum may also have the benefit that one acts as a backup to the other. For example, in a preferred embodiment, pressure is used to improve the seal to the vacuum chamber. If the vacuum chamber leaks, impedance is still reduced through the interface contact pressure generated by the pressure chamber. Alternatively, if a pressure chamber bursts or leaks or fails, a vacuum chamber can still provide enhanced interface contact pressure.

[0066] In another embodiment, a system is also provided to apply heat to the electrode to promote the flow of the electrode gel, enhancing contact and reducing impedance. Further, vacuum, pressure and heat can be combined to enhance the performance of the device. The device may be applied over a separate defibrillator pad electrode(s) or can be combined (directly or indirectly coupled, etc.) with the defibrillator pad electrode.

[0067] A device that enhances the contact pressure between the defibrillator electrode pad and the patient's skin and reduces the impedance during defibrillation and cardioversion is provided. The device can improve both the electrical coupling and physical coupling of the electrode to the patient. For example, electrical coupling relates to improvement of the resulting electrical impedance of the system including the patient and / or the interface between the system and the patient. Physical coupling relates to improvement of the quality and completeness of the physical contact between the patient and the electrode system.

[0068] The device may be applied to at least one defibrillator pad or can be integrated into the defibrillator pad(s). The case where the device is applied to (or on top of) the defibrillator pad, is referred to with the term "overlay". It is understood that all embodiments may comprise overlay devices or integrated devices. A system is described for coupling the device to the patient and to control the pressure applied at the defibrillator pad electrode to patient interface. A method for employing the device is also described. A pressure differential is employed which can include pressure, vacuum, or a combination of both. A heat source is also provided to optionally apply heat to the defibrillator pad to promote the flow of the electrode gel, additionally enhancing contact and reducing impedance. Embodiments that employ vacuum benefit in that the patient coupling interface (seal) is in compression, reducing the potential for the device to decouple from the patient's skin. In preferred embodiments, the device can be adhered to the patient's skin by an adhesive. It is shown here that in embodiments employing pressure, the required pressures can be reacted against the patent's skin (which puts the adhesive to skin interface in tension) using commercially available adhesive. In one embodiment, a commercially available conductive adhesive gel of a defibrillator pad is used to couple the device to the patient. This can be achieved for pressurized chambers, chambers under vacuum, and combinations thereof. In vacuum embodiments, a space is provided for in the device. When the device is coupled to a patient, the space and patient create a chamber which may be evacuated. In pressure embodiments, a chamber is created when a pressure chamber seal is provided for in the device, such as a bladder, for example. Multiple pressure and vacuum chambers are provided for, as well as combinations of the two. In embodiments where pressure and / or vacuum are provided from an external source such as a pump, a port may be used to allow fluid to pass into and out of the chamber. An example of a port is a "port disk" which is typically welded to a polymer film. For embodiments employing vacuum, it can be desirable to provide a system to aid in removal of the device. To enable removal of the device more easily from the patient, the vacuum may be released, allowing some air back into the vacuum chamber(s), aiding removal from the patient. In addition, pressurized fluid can be introduced into the vacuum chamber space, actively reducing the contact with the patient's skin, and helping to urge the device from the patient's skin for removal. For example, a differential pressure source may be used to accomplish this by employing the pressure side of a differential pressure pump. A fluid may comprise a gas and / or a liquid.

[0069] In embodiments that employ pressure, a chamber is pressurized. The required pressure is typically less than 3 psi and may be effective at pressures lower than 1 psi. The chamber is filled, which applies pressure to the electrode, urging it toward the patient. In embodiments where the device takes the form of an overlay, this is advantageous as the pressure chamber is self-contained and only needs to be placed over an adequate portion of the defibrillator electrode pad. The electrode (and patient) facing surface of the chamber should be flexible enough so that the pressure can be translated to the electrode / patient contact interface. The patient facing surface of the overlay device may include features that ensure that the air can be pushed out of the space between the overlay and defibrillator pad electrode. This allows the space to vent to atmosphere. The features can take many forms known to one skilled in the art, such as an embossed polymer film, gauze, screen, channels, hair-cell texture or finish, etc. This approach can also be used in integrated device embodiments. In some embodiments, the trapped air exit path is created at the location where the defibrillator lead wire exits the overlay. Lead wires may take the form of a wire, a printed circuit, a flexible circuit, or any other conductor that allows current to flow from the defibrillator to the electrode.

[0070] An aspect of this invention is that an even pressure distribution can be achieved at the electrode-patient interface surface. This improves the local electrode to skin impedance uniformity. This, in turn, can result in reducing or eliminating skin irritation, skin burn and / or skin breakdown.

[0071] In embodiments that employ vacuum, one surface of the chamber placed under vacuum is comprised of the patient's skin. Embodiments employing vacuum alone, may achieve a maximum or full vacuum of 14.7 psi (1 bar). The required vacuum is typically less than 5 psi and can be less than 3 psi and may be effective at vacuum lower than 1 psi. The vacuum pulls the device directly to the patient's skin. As the air is evacuated, the device does not have the potential to rupture when external pressure is applied during other procedures, such as if cardiopulmonary resuscitation (CPR.) is required. In cases where the electrode is placed on the posterior side of a patient, the patient may lie down supine on the ground, a patient table, or a bed, for example. Additional pressure on the device, caused by the patient's weight and other procedure related activities, does not pose a risk of rupturing the device. The approach described herein is applicable to any anatomical location, including anterior sternal, lateral, and posterior, which are typically used for defibrillation. It is applicable to all body sites that benefit from electrode placement. It's application includes, measurement, diagnosis, and treatment.

[0072] Embodiments including combinations of pressure chambers and vacuum chambers have the benefit that interface pressures of greater than 14.7 psi are achievable. However, it is not necessary to employ a combination to achieve higher interface pressure. Pressure chambers may enhance the performance of vacuum chambers by improving the quality of the seal. The combination can also be used to optimize the total interface contact pressure a pump can produce. Pressure chambers can also be used against the skin with vacuum applied over top of the pressure chamber. All pumps typically have an inlet and outlet. By using both the vacuum and the pressure side of a pump, overall performance can be improved. For example, this is useful when lower power pumps are employed, such as piezoelectric pumps and handheld manometer pumps. The pump fluid conduit, for fluid including gas or liquid, for vacuum and pressure can be designed to run in parallel for sake of design efficiency and to reduce the chance the fluid conduit becomes entangled with the patient, clinician, or other devices during use. A dual lumen tube may be used, for example, with tubes running side by side, co-axially, or in other configurations as known to one skilled in the art. Fluid conduits with more than two lumens are also contemplated.

[0073] The outer layer or layers of the device can be configured to conform to the anatomy of the patient. Materials that can make suitable construction layers include but are not limited to polymer, sheet, film, fabric, composite, fiber reinforced material, polymer coated fabric, for example. Suitable polymers include but are not limited to polyurethanes, polyethylene, polypropylene, polyamide, vinyl, PVC, PVDF, and silicones. Combinations of materials are also contemplated. Materials may include reinforcements such as fibers, fabrics, nanomaterials, exfoliated clays. Various manufacturing or forming techniques are contemplated as well. Manufacturing techniques include but are not limited to injection molding, vacuum forming, press molding, and laminating, for example. The outer layer can provide the structural integrity to withstand the force to be reacted. Seals made within the device may be produced using an adhesive, polymer welding (such as heat or RF welding), or any other sealing method known to one skilled in the art. Some embodiments can benefit from a reinforced film, such as a fabric reinforced film to add to the strength of the device. Materials such as polyurethane coated nylon fabric are good options as they are heat, ultrasonic, and radiofrequency (RF) weldable for production. The fabric can take the form of plain weave or other forms such as twill (2x2), five harness satin, non-woven, etc. such that the material is more conforming to the patient's body shape. Conformable fabrics are well known to those skilled in the art.

[0074] Multiple chambers may be used or formed in a pressure- or vacuum-containing structure. Chambers may be segmented and / or baffled. For example, it is desirable that the device conforms to the geometry of the patient. One can think of the patient surface as a complex contoured surface. Pressure chamber conformability can be increased by using multiple chambers. It can also be increased by segmenting or welding the top and bottom surfaces of the chamber so that zones do not fill with air (or other fluids which may be used). This allows the segments to act like they are hinged so that the device remains flexible when pressurized. Zones or chambers may share pressure inside the architecture of the device or may be fed by multiple air inlets such as conduits, tubes, channels, or structures that define a passageway.

[0075] In a preferred embodiment, a layer is included which is electrically insulative. This is configured to protect the clinician from electric shock. In another embodiment, a layer is included which is thermally insulative. This is configured to protect the clinician from a heat source. The protective layer(s) may comprise the outer layer or layers. The device can be placed over a portion of at least one defibrillator pad. One device can enhance contact or electrode-patient contact pressure to at least one defibrillator pad. It can also be placed over or integrated into at least one ECG electrode.

[0076] The device can also be employed for other biosensors. For example, one or more ECG electrodes.

[0077] The device eliminates the need for a technician, clinician or other individual to actively push on the pads to reduce impedance.

[0078] The device can be sold separately, sold in a set or kit with the defibrillator pads, or can be integrated into the defibrillator pads. A kit may include the device and other components required in the system. In certain embodiments in which an overlay device is sold as part of a kit, the overlay may or may not be pre-assembled (coupled) to the pad prior to attachment to the patient. The pre-assembly may take place as part of the kitting process, or it may be done by the user. Alternatively, the defibrillator pad may be placed on the patient and then the overlay is applied over some or all of the defibrillator pad. The device can be part of a system that may include any one or more of the defibrillator, associated hardware such as ETCO2 monitoring, ECMO, bag, valve mask (BVM) equipment, emergency medical services (EMS) equipment, fluoroscopy equipment, and other associated equipment which may be used in relation to defibrillation and cardioversion.

[0079] It is understood that this device can be compatible with all associated existing functions of defibrillator pads, such as ECG monitoring, pacing, and measuring of rate and depth of CPR.

[0080] A differential pressure source may provide vacuum, pressure, or both. Differential pressure sources can include but are not limited to, a manometer bulb, pump, CO2 cartridge, room air, air compressor, chemicals or chemical compositions, a two or more-part reacting chemical, hospital room gasses, a venturi vacuum, a pump, a piezoelectric pump, orally applied by the user's mouth. Any suitable differential pressure pump may be used as is known to one skilled in the art. In some preferred embodiments, a manometer bulb is used to create vacuum and / or pressure. In other preferred embodiment my use, a piezoelectric vacuum pump, a rotary vane pump, the hospital vacuum supply, a venturi vacuum, or any other vacuum source known to one skilled in the art. Any combination may also be used. One form may be primary, with others being secondary, tertiary, etc. One may act as a backup to another. In one embodiment, oral application of pressure or vacuum may be employed as a backup to a primary method. A check valve may be employed so that a constant or continuous application of pressure or vacuum is not needed by the user or so that an applied pressure or vacuum can be retained over time. The check valve may be configured, for example, to let fluid into a pressure chamber but not let it back out, or to allow a chamber to be evacuated but not let the fluid back in.

[0081] In some embodiments, the vacuum and / or pressure source may be turned off once the desired impedance level is achieved. It is not required that differential pressure be maintained during the entire defibrillation or cardioversion procedure and benefits can arise from turning off the pressure differential supply. It is also not necessary to maintain active contact pressure enhancement during the entire procedure. Valving, such as check valves, can be employed to retain the vacuum and / or pressure in the device, in certain embodiments, it may be desirable to allow the air to escape the device. In addition, for example, this can be useful in embodiments where CPR is delivered and one would not want to rupture a chamber. Embodiments may include impedance sensors and pressure sensors in the system.

[0082] Ways to activate a differential pressure source (turning it on) include but are not limited to: 1) Manually by flipping a switch, pushing a button, etc.

[0083] 2) When the device is attached to the patient. a. It can be activated by a sensor. b. A resistance or impedance measurement through the defibrillator can switch on the pressure differential pump. This is true whether controls are integrated into device, are separate from the device and / or are integrated into another associated device such as a defibrillator. c. The control logic can be designed to require the pads to be placed and the resistance / impedance to fall in a range indicating that the pads have been properly applied to the patient.

[0084] Deactivation of the pressure differential source can also be manual or triggered by another source, such as the defibrillator. Turning off the defibrillator could turn off the pressure differential source, for example. The pressure differential source may be turned off after a preset amount of time, for example. In a preferred embodiment, no additional steps are introduced or required in the use of this device when compared to a defibrillator pad that does not include pressure differential and / or heating features. In a preferred embodiment, automatically turning the vacuum source, pressure source, or pressure differential source on and off eliminates introducing a new step in the user's workflow. In embodiments including a heat source, the application of heat can also be triggered by the vacuum, pressure, or any other control algorithm as would be known to one skilled in the art, such that additional steps are not introduced.

[0085] Communication with the differential pressure source in order to control it, can be by Wi-Fi, Bluetooth or any other wireless technology, as well as wired technologies.

[0086] The differential pressure conduit can go under the adhesive, through the adhesive, between the adhesive and a chamber, through a chamber, or anywhere else in the system. The seal needs to be adequate such that losses and leaks do not overwhelm the pump flow rate. However, a perfect seal is not required.

[0087] Relief valves may also be incorporated into the device. For example, a pressure relief valve can protect a pressure chamber from rupturing. The relief valve may be placed anywhere in the pressure system. For example, it can be placed in tubing between the pump and pressure chamber. It can also be attached to the pressure chamber. The pressure relief setting may be variable or set to a specific pressure level. For example, in preferred embodiments, a pressure relief valve of 1 psi, 2 psi, or 3 psi may be appropriate to achieve the desired electrode to patient interface pressure. For example, it may be chosen so that the pressure chamber does not burst. A relief valve can provide the added benefit of keeping a chamber from bursting when additional external pressure is applied to the device, such as could happen during CPR. In vacuum embodiments, a relief valve may limit the maximum vacuum that a chamber may be subjected to. As the patient's skin is subjected to the vacuum, limiting the vacuum may reduce irritation or damage to the skin. In addition, the vacuum source does not need to be limited in its vacuum range as the relief valve limits the maximum vacuum to the chamber. Vacuum may be limited to 1 psi, 2 psi, or 3 psi, for example.

[0088] Additionally, relief valves may serve as indicators, informing the user that adequate pressure and / or vacuum have been achieved in a chamber.

[0089] Pressure and vacuum regulators may also be used in embodiments and systems of this invention.

[0090] A manifold may also be used to control the pressure differential selectively to two or more chambers and / or multiple defibrillator pads. In this way, for example, one or more leaking chamber could be isolated from the system so that the other chambers would see the proper pressure differential desired, without interference for performance degradation caused by the leaking chamber.

[0091] In certain embodiments, the pressure and / or vacuum chamber may be pressurized by a chemical reaction, this may be initiated manually or electronically or by any other means known to one skilled in the art. In this case, it may be difficult to control the exact pressure level generated by the chemical reaction. A relief valve can be used to ensure that pressure rises to a set point level and excess pressure is relieved so that the set point pressure is maintained.

[0092] In embodiments where a chemical reaction is used to develop pressure, the reaction may be selected to be exothermic, giving off heat. The pressure and temperature reactions can be combined or separated. One or more reactions can be used or a combination of a chemical reaction for pressure / vacuum and electrical for heat, a pump for pressure and chemical reaction for heat, for example. Any combination can be used. Application of heat (in any form) provides the benefit that the heat can aid in the flow or deformation of the conductive surface, additionally aiding in the performance of the device. Additionally, it can make the electrode more conformal to the patient's anatomy.

[0093] As part of the device or system, impedance may be actively monitored, continuously or at certain intervals, to ensure proper contact is being achieved and maintained. This can be part of a closed loop control used to turn the pressure differential source on and off. Transthoracic impedance (TTI) can be measured as well as skin-electrode impedance at the electrode / skin interface. TTI is an indicator related to the way in which the electric shock of defibrillation will pass through the heart. Skinelectrode impedance provides a measurement of the quality of the electrical interface between the electrode and skin. Other measurements may be made as well, such as resistance, reactance, and phase angle. These may be acquired at a variety of frequencies and differential pressures, for example.

[0094] In addition, varying or cycling the vacuum and / or pressure can be used to enhance contact and reduce impedance. In certain embodiments, pressure and / or vacuum can be varied by "bumping" or pulsing, increasing and decreasing the pressure applied at the interface so that the electrode can seat itself to the patient, enhancing contact and reducing any air that may be trapped between the patient and electrode. A feedback control loop can be included that measures impedance so that vacuum and / or pressure can be varied to enhance performance. Impedance measurements can include TTI, skin-electrode impedance, or others that may be pertinent to the application. Components of impedance such as reactance, resistance, and phase angle, may be used as markers as well. The rate of change of these markers may additionally be used. For example, a decreasing rate of change may tell us that no further benefit in impedance reduction may be achieved, and the user (or system) may defibrillate at this time, given that adequate levels of impedance are reached. An indicator, readout or other method that provides the data to the user may be included as well. Any data generated may be stored in the device, communicated to another device (by wire or wirelessly, for example) for use and / or storage, and can be part of The Internet of Things (loT). In this way, data for a single patient may be saved for analysis, as well as data for many patients. Examples of data use are to track device performance, develop improved protocols for device use, improve device design, and improve efficacy. A gauge may be included in the system to measure the level of vacuum and / or pressure. The gauge may include a gauge that is analog, digital, manual, electronic, or any gauge familiar to one skilled in the art. This can be used as a measure of the contact interface pressure. It can also be used to determine if leaks exist in the system. For example, in a vacuum system, the level of vacuum may be measured. If the rate of vacuum (vacuum measurement / time) increases is not adequate or the level of vacuum cannot be maintained, the system may continue evacuating or alert to keep evacuating. In the case of an electric pump, for example, a closed loop control may be used to command the pump to keep pumping or increase the pumping rate. In addition, the system may tell the user to try to seal any leaks. The indication can be one or more of, visual, voice, a light, etc. For example, red could indicate to the user that they need to try to seal the device against the patient more effectively, yellow could be vacuum or pressure level is building but not at a level adequate for defibrillation, green could be vacuum or pressure achieved. An audible voice can be employed to similar ends. In some embodiments, adequate interface enhancement may be communicated to the defibrillator. Any of the indications described above can also be employed to signify that adequate impedance reduction has been achieved.

[0095] A pressure sensitive material can also be incorporated into the device to indicate adequate contact pressure has been achieved. This can take the form of a colored dye, a pressure sensitive dot or sheet, a piezoelectric pressure transducer, or other forms known to one skilled in the art. In overlay embodiments in which clear films are used to fabricate the device, one can easily see a pressure sensitive material embedded in the device.

[0096] Electrode-Patient Contact Pressure is the pressure applied at the electrode to patient interface. In a preferred embodiment, the applied force is greater than 8kg (~18 pounds force). On a 4" diameter pad that would correspond to greater than ~1.5 psi of pressure.

[0097] Many ways are possible to produce heat. Chemical packs for glove warmers are a good example (two or mare part chemical reaction). Heat can also be supplied electrically. For example, through electrical resistance heating. Heat may also be provided by a warm fluid.

[0098] Devices of this invention can take the form of a defibrillator pad or electrode pad accessory that reduces impedance with the electrode pad simply attached to the defibrillator module that supplies the electric shock. The invention described herein can be used for diagnostic and therapeutic applications. It can be used in applications where the electrode is active or passive.

[0099] An aspect of embodiments that take the form of an overlay, is that it is not necessary to cover the entire defibrillator pad to achieve suitable impedance reductions. Complete 100% coverage of the pad is not required. For example, the overlay device may be placed over a defibrillator pad electrode but not cover the portion at which the conductive wire cable exits the pad. This can make adhering the overlay device to the patient a simpler task. In addition, it is not required that the user achieves perfect placement of the overlay over the pad. In certain embodiments, the overlay device takes the physical form of a donut and goes around the electrode lead (for example, around the lead of a Medi-Trace™ Cadence™ 22770PC). The device can include a pass-through for the electrical and other connections. The device can include an electrical lead hook, male and female for example, so that the pads can be connected to the pressure differential source or unit and the leads can also be attached to the pressure differential source or unit. The overlay device can also be configured to take the form of a "C" shape, configured with a slot, or any other form allowing it to go around the electrode lead. The device may also include additional adhesive seal material to encapsulate the electrode lead wire. In some embodiments, a feedback loop from impedance and / or interface pressure monitoring (whether direct or indirect) may be used to indicate that adequate placement and contact interface quality have been achieved. Feedback data can be generated from a number of sources such as a dedicated measuring device, a defibrillator, and other data acquisition tool and / or indicator known to one skilled in the art.

[0100] The invention, in preferred embodiments can be disposable, whether taking the form of an overlay or as an integrated defibrillator pad solution. However, embodiments can also be reusable. That is, for repeated use and potentially on multiple patients. For example, the vacuum system can be integrated into an electrode which seals against the patient through the application of vacuum. The seal is comprised of a gasket portion. The gasket portion may couple to the patient adhesively or not. It is only necessary that an adequate seal is achieved, with a leakage rate low enough to allow adequate electrode-patient interface pressure to be achieved. Conductive gel may be applied to the electrode at the patient contact face. These gels can be removed or cleaned off and then reapplied between uses. This application is similar to the way in which electrode gels are typically applied to traditional manual defibrillator paddles. In one embodiment, a traditional defibrillator paddle may be modified to include a vacuum seal around its perimeter. In this way, the user is not required to maintain pressure on the electrode paddle, and higher levels of interface contact pressure are achievable. As well as conductive gels, disposable conductive electrode pads can be used on the contact face, such as the 3M Defib Pads 2345N. These conductive pads typically consist of an electroconductive gel supported by a porous-woven fabric.

[0101] Devices of this invention can be used for both adult and pediatric applications.

[0102] In embodiments where vacuum is used, it increases the pressure between the defibrillator electrode and the patient, thereby pulling the electrode toward the skin of the patient and urging the electrode into improved contact with the skin of the patient, so as to increase the continuity of the contact and optimize the surface-to-surface contact between the electrode's surface and the patient's skin surface. For example, one can place an open cell foam layer over the defibrillator pad. Then seal the foam and defibrillator pad to the patient under an impermeable layer such as a sheet of plastic. A vacuum source then introduces vacuum into the space containing the foam and then pull a vacuum, evacuating the air. By employing partial to full atmospheric pressure, one can achieve up to ~14.7 psi (1 bar) enhancing contact pressure at the electrode-patient contact surface. The vacuum can be produced in many ways, including a manual method such as a manometer pump. Vacuum can be produced using a CO2 cartridge blowing through a venturi vacuum generator. Vacuum can alternatively be produced using room air / gas running through venturi vacuum generator. Vacuum can also be produced using a small piezo-electric pump powered by many possible electrical sources - battery, defibrillator, etc. A human is also able to produce approximately 5 psi of vacuum by oral means of sucking on a tube. In one embodiment, the user is able to orally draw a vacuum using his or her mouth for creating negative pressure (or in other embodiments can alternatively be used to create a positive pressure or pressure differential). A check valve and or filter can be placed between the vacuum area and the mouthpiece. Any combination of vacuum source is possible. One simply needs at least one vacuum source. Combinations can be beneficial. For example, a power source may fail, and oral backup could allow the device to still be used. The oral vacuum could also be particularly useful in EMS situations. The use of two or more pumps can also provide the benefit of employing a pump with high flow rate in combination with a pump of high stall vacuum. The higher flow rate pump acts as a roughing pump while the lower flow rate pump achieves a higher vacuum. The pump(s) may be located in many places as would be known to one skilled in the art. For example, the pump can be a separate unit, can be coupled to the defibrillator pads, can be integrated into the pads or overlay, can be strapped to the patients arm, can be hung from and IV bag holder, may be coupled to a stand (which may be on castors), or may be part of the physical plant of the clinical facility.

[0103] It is recognized that any pump can be used as a vacuum pump. For example, a bulb type manual pump (manometer for example) has an inlet and outlet. By swapping the inlet and outlet end connection, the pump can be used for pressure or vacuum. This is true of piezo-electric pumps and most other pumps as well.

[0104] In certain embodiments of the vacuum device, once the defibrillation procedure has been completed the vacuum can be "release" to allow air to flow back into the vacuum chamber to aid in removal of the device. In addition, air can be actively pumped back into the vacuum chamber to aid in releasing and removing the overlay and / or defibrillator pad from the patient. A circuit of air logic can be employed, using two-way or three-way valves to redirect the exhaust air into the vacuum space. The pressure sensor that senses vacuum can be used to sense the pressure level so that the patient's skin is not damaged. One strategy is to return the space to ambient pressure or slightly above ambient pressure to help in the removal of the device, breaking the seal. In cases where adhesives are employed this can also aid in removing the adhesive from the patient.

[0105] Pulsing the vacuum (increasing and decreasing the level of vacuum) may allow the defibrillator pad to seat optimally and reduce impedance. It may even be desirable to employ positive pressure during pulsation. Adhesive used to adhere to the patient's skin should be selected from those that are bio-compatible. It has been found that the conductive gel adhesives traditionally used in defibrillator pads make an excellent vacuum seal with the patient's skin. Surprisingly, it has been discovered that an adequate vacuum (e.g., 1 psi or 3 psi or 5 psi or even 12 psi) can be achieved by use of commercially available electrolyte gel adhesives, such as those employed in Medi-Trace™ self-adhesive defibrillation electrodes. For another example, HydroGel Tape is available from various sources, such as Blasters Tool & Supply Company (item # 15567-120). This HydroGel Tape does not include an electrolyte and is, therefore, applicable to certain embodiments.

[0106] In a preferred embodiment, the gel adhesive works as both the adhesive and the vacuum sealant. In a preferred embodiment, the gel adhesive works as any one or more of the adhesive, the vacuum sealant, and the electrolytic coupling agent. For example, adhesive electrodes often comprise a hydrogel which can contain an electrolyte such as silver / silver chloride (Ag / AgCI). An electrolyte is a substance that breaks apart into electrically charged particles, called ions, when dissolved in water or body fluids. Hydrogels are polymeric materials consisting of a sparse network of polymer chains embedded in an aqueous medium. Hydrogels make excellent tissue interfacing materials as they are soft, exhibit tissue-like mechanical properties, are highly biocompatible, and can contain additional conduction enhancers such as an electrolyte. The outer perimeter adhesive gel may or may not contain an electrolyte for conduction. The absence of a good conductor at the perimeter allows the entire outer assembly that is exposed to the operator / user to be used to provide some electrical safety. A large variety of adhesives that can be employed to provide a vacuum seal are known to those skilled in the art. Gasket material, such as silicone or elastic polyurethane may also be used. Any combination of sealants and adhesives may also be employed to provide a desired adherence and seal. In some preferred overlay embodiments, the adhesive can be non-conductive to improve safety.

[0107] In various embodiments, the electrode may take the form of a "dry electrode" which does not contain a liquid or gel electrical coupling agent. These electrodes can benefit greatly from the application of contact enhancement as they don't have the benefit of an electrolyte liquid or gel. In addition, when a dry electrode is employed as an embodiment of this invention, a secondary liquid or gel electrolyte (such as Signa Gel® electrode gel and Redux® electrolyte) the differential pressure can be used to ensure even distribution and penetration of the electrolyte.

[0108] It has been found that approximately 8 kgs of feree (17.6 pounds force) generates about 95% of the benefit in transthoracic impedance (TTI) reduction, while 12 kgs of user-applied force has been the recommendation of the European Resuscitation Council. It has also been shown that application of approximately 10 to 20kg of force applied to anterior apically placed defibrillator pads can lower TTI and improve the success rate of cardioversion. Preferred embodiments of this invention produce forces greater than or equal to 8kg and within this range. As embodiments of the invention create force through electrode to patient interface pressure increase, the benefits of the invention include an increase in contact pressure. A typical contemporary defibrillator pad electrode, such as the Medi-Trace™ Cadence™ 22770PC, has dimensions of approximately 5.375 inches by 3.5 inches. This results in a surface area of 18.8 inches'^. A force of 8 kgs corresponds to 17.6 pounds. In order to achieve 8 kgs-force (17.6 pounds) for a typical electrode, for example, an interface pressure of approximately 0.9 pounds per square inch (psi) can be generated. This corresponds to 0.062 bar and 46.5 mmHg. A 20 Kgs-force is achieved at approximately 2.3 psi.

[0109] For vacuum embodiments, the adhesion to the patient is in compression, and requires minimal adhesive strength. For pressure embodiments, the adhesive used against the patient skin must be adequately strong to resist the urge for the device to become detached from the patient. For the defibrillator pad described above, of approximately 5.375 by 3.5 inches, one can calculate a perimeter of 17.75 inches. At 17.6 pounds-force, the perimeter adhesive must resist about 1 pound per linear inch. If a perimeter adhesive is used surrounding the electrode of 1 inch wide, the adhesive needs to be able to resist 1 pound per square inch, which is well within the capability of commercially available adhesives.

[0110] One source for piezoelectric pumps capable of generating a pressure differential is The Lee Company, which can generate vacuum and pressure. Preferred embodiments may use piezoelectric pumps products by The Lee Company, including those in the BL, XP, and HP product line. These pumps have typical maximum vacuum pressures of 200 mmHg, 300 mbar, and 400 mbar respectively. A pressure of 200 mbar is equivalent to 2.9 psi and is well within the capability required to produce the 0.9 psi through 2.3 psi vacuum desirable to produce contact pressures and resultant forces of this magnitude. The Lee Company pumps operate in a voltage range of 3.7V to 5V. A typical 18650 lithium-ion battery with 10000 milli-amp-hours can run a BL pump for approximately 20 hours. This is more than adequate for the application and one can contemplate a much smaller battery. Piezoelectric pumps are also known for their compatibility with MRI machines. One of several embodiments that could be made to operate in an MRI environment (MRI conditional) uses a piezoelectric vacuum pump. In this case it is desirable to utilize an MRI compatible battery. One typical MRI compatible battery widely used is available in "C" size at 1.5V. Three of these batteries used in series can produce 4.5V, in the range for these pumps. For example, a commercially available Diamond MRI Laryngoscope Battery, which is "C" side, can operate in MRI field strengths up to 3 Tesla. Another example is the Saft LS 14500 AA lithium battery, which produces 3.6 volts. Any battery or other power supply may be used, when properly conditioned, to drive the desired pump at its operation voltage and other requirements. A large variety of batteries are available as is known to those skilled in the art.

[0111] Typical The Lee Company piezoelectric pumps are shown in the table below. The device of our invention, in a preferred embodiment, can produce 4.0 psi of vacuum (~100 mbar). These pumps have a stall vacuum significantly greater than 100 mbar. In addition, they can supply a similar level of pressure, therefore they provide a good choice for an embodiment in which positive pressure is applied to enhance the contact interface pressure. By using both the pressure and vacuum side of the pump, the total contact interface pressure can be increased. In a preferred embodiment, a BL Series pump is utilized as it provides a good combination of high flow rate and high pressure differential.

[0112] Table 1 : Typical The Lee Company piezoelectric pumps

[0113] Rotary vane pumps are also an exemplary class of pump that work well with this invention. Units such as the Thomas Rotary Vane Pump Miniature Series by Gardner Denver come in a wide range of max pressure / vacuum as well as flow rate. They can be powered with 12 volt and 24 volt electricity, which is convenient and the pumps tend to be relatively quiet. In testing, for example, it was found that the Thomas Rotary Vane Pump G 07 provides a good performance. Other exemplary pumps include impeller, scroll, scroll cage, piston, and any other pump as is known to one skilled in the art.

[0114] The Aircast® Hand Bulb Air Pump is an example of a manometer like air pump. The Aircast pump is particularly suited to this application as it has fittings at each end and clear labeling for "Inflate" and "Deflate". Both vacuum and pressure embodiments can be driven manually by the Aircast Pump, with air potentially flowing in, out, or both ways.

[0115] One aspect of this invention that has been found is that increasing the contact interface pressure drives the electrolyte into the patient's skin, improving coupling and reducing impedance. This benefit remains when the contact interface pressure is reduced. This means that the pressure differential does not need to be maintained throughout the procedure, as much of the contact enhancement benefit is imparted when the desired pressure is initially achieved. Higher contact pressures may help drive the electrolyte into the patient's skin, but are not necessary beyond the point where adequate impedance reduction is achieved. Another aspect of this invention is that it can easily be made to be x-ray compatible (radiolucent) as well. Common defibrillator electrode pads are sold in x-ray transparent (radiolucent) versions or varieties (such as the Medi-Trace™ Cadence™ 22770R). The components used to produce the pressure and vacuum chambers, whether separate (for example, as an overlay) or incorporated into the electrode pad assembly, can be produced from radiolucent materials. This is highly desirable as defibrillator pads are often used in the cardiac catheterization lab, where x-ray c-arm systems are typically use for imaging purposes. CT and other x-ray modalities are also used. MRI compatible embodiments of this invention are also anticipated. All materials of the pad and / or overlay can be selected to be MRI compatible. Several vacuum sources are available that are MRI compatible for this application, including piezoelectric pumps, and the hospital wall vacuum, for example. The ability of embodiments of this invention to be compatible with a wide variety of imaging and treatment modalities is a distinct advantage over prior solutions that attempt to increase electrode to patient contact pressure.

[0116] Another benefit of this invention is that the components are relatively inexpensive and can be disposable (considered a consumable item) and employed for single patient use. The pressure differential source (which creates pressure and / or vacuum), whether manual, oral, or otherwise powered pump can also be developed to be relatively inexpensive and can be designed to be disposable or part of system that is reusable. In some preferred embodiments, the pressure differential source may be handheld, integrated into a defibrillator or other device, or separate in its own configured system. Reusability of the pressure differential source can have the benefit of allowing a more expensive part of the system to be purchased less often. In addition, sensors, logic, controls and other systems may be integrated with the pressure differential source as would be known to one skilled in the art. In embodiments of this device, the source of the pressure differential can be coupled to the device through a conduit, such as a tube, channel, etc. The conduit may be run in parallel with one or more electrode lead wires or can be run separately. In other embodiments, the source of pressure differential may be directly mounted to the overlay structure or electrode pad structure. The conduit can be connected through the outer layer, under the perimeter adhesive, for example. The vacuum can be connected to the vacuum distribution portion of the device.

[0117] Vacuum, pressure, and / or heat sources can be actively or passively controlled. Active control can be provided in many ways and from a variety of control units. Active control can be provided by the user, by a dedicated control unit, by a defibrillator unit, another device in the medical setting, a computer, or other system as known to those skilled in the art. Any one or more of pressure, vacuum, and temperature measurement can be integrated into the device. A force or pressure sensor may be used. Embodiments include those in which the data can be relayed back to the controller. The data may be used to actively control the system and the data may be communicated to the user. Direct interface pressure may be measured by one or more of a pressure sensitive pad, pressure sensitive resistor, a piezoelectric pressure sensor, etc. Vacuum, pressure, pressure differential, temperature, impedance, rates of change of measured attributes can all be incorporated, for example.

[0118] The control unit can provide the power for an electric heat component, and / or it can provide the power to activate a heat source such as a chemical reaction.

[0119] A vacuum containing layer operates much like a vacuum bag in composites manufacturing. In composites manufacturing a part is placed on a tool. A distribution media is placed over the part, followed by the vacuum bag. The vacuum bag is then sealed to the tool. A vacuum source sucks / removes the air out, allowing a maximum of 1 bar atmospheric pressure (14.7 psi) to be applied to the part, pushing it onto the tool. In one embodiment, the defibrillator electrode and gel take the place of the part. The patient serves as the tool. Just as heat can allow a composite part to conform to the tool, heat can allow the electrode and gel to conform to the patient. Of course, this entire system can be incorporated into the defibrillator pad. The distribution medium can be incorporated into the design of the vacuum bag or outer shell / layer. It is understood that other layers, structures, and features can be placed outside (distally) to the outer layer. In composites manufacturing, the distribution media material may also be referred to as a breather or bleeder.

[0120] Distribution media can be of any form known to one skilled in the art, such as, screen, fabric, gauze, beads, open cell foam, hair cell finish polymer, pillars, channels, stand-offs, embossed surfaces (of film, sheet, or foam, for example), textured surfaces, etc. A film such as that used in home food vacuum and sous vide equipment is an example of a film with an embossed surface that remains open to evacuation. The distribution media is comprised in the space such that fluids may be evacuated without the chamber becoming blocked. Open cell foams have an open structure that allows fluids to pass through them. Open cell foam is widely available in many polymer chemistries and many form factors (such as sheet). Suitable open cell foams are available from United States Plastic Corporation, American Flexible Products, and many other sources.

[0121] Contemporary electrode pads generally use conductive adhesives. These adhesives must adhere the electrode to the patient and provide adequate electrical conductivity to the patient. In certain embodiments of this invention, these adhesives are used to adhere the device to the patient. Embodiments of integrated devices may use the conductive adhesive to adhere the device to the patient. It has been discovered that in electrode to patient contact interface pressure and / or increase in temperature can enhance the electrical performance of these adhesives.

[0122] Embodiments of this invention can employ conductive gels, liquids and pastes at the interface of the electrode to a patient. These do not need to be adhesive as embodiments of this invention can separate the function of the electrolyte conductor from the function of coupling the patient to the electrode. The electrolyte can take the form of gels, pastes, or creams. Parker Signa Gel® electrode gel and Redux® electrolyte cream are examples. As embodiment of this invention hold the electrode in place and urge it toward the patient, an electrolyte gel, liquid, or paste may be used between the electrode and the patient. As these electrolytes do not need to perform the job of an adhesive, they may be formulated to provide better electrical performance and lower impedance. In addition, the device can be configured such that the electrolyte is drawn across the electrode / patient interface when contact pressure is increased. Vacuum may be used to draw a liquid or gel into empty spaces. Pressure may be used to force the liquid or gel into the interface. Heat may be used to allow the electrolyte to flow more readily.

[0123] When the electrode patient contact pressure is increased, a gel electrolyte can be caused to be distributed across the patient-electrode interface, decreasing impedance. This results in a "wet" layer and is commonly referred to as a wet electrode. For example, in one embodiment, the electrolyte can be configured to be drawn across the face of the electrode when vacuum is applied. Vacuum can be presented on one side of the electrode with a container of electrolyte at the other side. When pressure is intensified by vacuum and / or pressure, the electrolyte container can be configured to break or open such that the electrolyte is disbursed across the interface. In an embodiment, features are created on the face of the electrode to aid in the electrolyte spread. These features can be channels, embossed geometry, a hair-cell finish, or any other feature that allows the electrolyte to disburse. Fluid flow passageways may also be contained within the device. It may also be desirable to include an electrolyte trap such that the electrolyte can't reach the vacuum source. The trap can be a container, and absorbent pad, a syringe-like structure that disgorges its content when under pressure or vacuum, or any other containment method as would be known to one skilled in the art. A container of electrolyte can be located near the center of the device with electrolyte being squeezed to the edges. Similar designs may be used for pressure systems, as known to one skilled in the art.

[0124] The electrolyte may be applied by the user or incorporated into the device. It may be stored in a container which disburses its contents when pressure is intensified. The container may be warmed to aid in the flow of the electrolyte and to increase the electrolyte conductivity.

[0125] The electrolyte may be colored to allow the user to more easily visualize the spread of the electrolyte and ensure that it covers the surface of the electrode / patient interface.

[0126] With the application of heat, the gel electrolyte and / or electrode adhesive can be formulated to work better as the electrolytes have the potential to move electrons more freely at higher temperatures and lower viscosities.

[0127] Features, such as small channels or pillars, may also be included in the electrode gel at the interface with the patient to allow vacuum to travel and maximize patient contact.

[0128] A gauge or indicator may be included to measure the amount of vacuum. A check valve may be used to ensure air does not leak back into the device. The check valve may be incorporated in the air line, the chamber port, the chamber itself, or anywhere else as known to one skilled in the art. In some embodiments, the check valve may have an allowable leakage rate, as a perfect seal is not required. A valve set to a specific vacuum level may be used to ensure a specific range of vacuum is achieved.

[0129] The outer layer or shell may have artwork and / or instructional information printed on it. Of course, there may be additional layers or features added to the outside of the outer vacuum containing element.

[0130] Gas Distribution Medium (GDM) - Distribution media assures an open path for fluid to flow in and out of the device and its chamber spaces without becoming blocked or pinched off. It can be used in both pressure and vacuum embodiments. For vacuum embodiments, for example, the GDM serves to allow the fluid to be evacuated from the device and to distribute the fluid, whether the fluid is in gaseous or liquid form. This allows the atmospheric pressure to be distributed evenly over the defibrillator electrode, enhancing patient contact. The GDM also keeps the vacuum from blocking the vacuum inlet, which would keep the device from being properly evacuated. The GDM can take many forms including but not limited to an open cell foam, a screen, a fabric, a non-woven material, a batting, vacuum beads (as used in vacuum cushions which are typically made from polystyrene or polypropylene). Or any other material can be used that allows enough open space such that the air can be evacuated. The GDM can also be incorporated into the outer layer. For example, when using a polymer based outer layer, the GDM can be embossed or otherwise molded into the outer layer. An example of this is the embossed polymer film material that is used for vacuum packing food. These often have crisscross channels or stand-offs embossed into them so that the air can be evacuated virtually everywhere. These materials are then sealed around their perimeter. This approach can also be taken to produce the device described herein. An outer perimeter can remain flat to carry an adhesive sealing layer which is then used to adhere the device to the patient. The embossed or molded design can be stand-offs, a crinkle pattern, a spider web, a hair-cell finish or any other design that allows the air or fluid to be evacuated as would be known to one skilled in the art.

[0131] It is understood that embodiments of this invention may also comprise a component or components which additionally hold the at least one device to the patient. This can be a strap, a belt, a harness, a vest, a jacket, as well as other structures known to one skilled in the art.

[0132] The vacuum may be created by a chemical reaction. A "getter" is an example. Most reactions involving combustion produce more gaseous molecules than they consume.

[0133] If methane is burned, a partial vacuum can be created :

[0134] • CH4 (g) + 2 02 (g) ® C02 + 2 H2O

[0135] • The reaction uses 1 methane molecule and 2 oxygen molecules and produces only 1 carbon dioxide molecule (and water).

[0136] If propane is burned, a partial vacuum can be created :

[0137] • C3H8 (g) + 5 02 (g) ® 3 C02 + 4 H2O

[0138] • The reaction uses up 1 propane molecule and 5 oxygen molecules and produces only 3 carbon dioxide molecules (and water).

[0139] In a confined space, this will produce a partial vacuum, which will increase in strength until the methane (or propane) or oxygen is depleted. There are many other examples of such chemical reactions that can be used to generate a pressure differential. In some embodiments, an exothermic reaction can be used to develop both heat and differential pressure. For example, a two-part foaming agent can be used in who a membrane is broken to allow the two parts to mix. The chemicals give off both heat and gas. Expanding polyurethane foams used in packaging, are a good example of this chemical effect. There are many such reactions as are known to those skilled in the art.

[0140] For embodiments where non-manual power is employed, the power may be provided by a chemical reaction, electricity, a battery, the associated defibrillator unit, etc. As the defibrillator already contains a power source, it provides a convenient power source for inflation, deflation, and heating, depending on the embodiment.

[0141] In preferred embodiments, materials and components can be selected such that the device has minimal impact on the quality of imaging in both x-ray and MRI imaging modalities.

[0142] Contraction or expansion to apply vacuum can be supplied by an air or moisture activated chemical reaction.

[0143] An indicator can be incorporated, coupled, or otherwise associated with the device to show the user that at least one of adequate pressure, vacuum, and heat have been applied. A gauge can be incorporated into the device, or a visual or audible indicator. The indicator can be incorporated into the defibrillator. The indicator can communicate to another device via wire or wireless system.

[0144] Power for the vacuum pump may be manual, electric, gas supply or any other power supply known to one skilled in the art. Power may be provided by the defibrillator.

[0145] With this device, it is possible to make a given defibrillator pad design smaller, as the impedance will be lower. For example, it may be desirable to produce smaller defibrillator pads for pediatric application.

[0146] Although rectangular pads are shown in the figures, all other geometric shapes are possible, such as round, oval square, hexagonal, etc.

[0147] It is understood that the device of the invention can be combined with any other accessories to defibrillator systems. This includes accelerometers, pulse oximeters, CO2 measuring devices, etc.

[0148] Once vacuum is applied and contact is enhanced, the vacuum does not need to remain as the contact has already been enhanced. This allows a battery-operated pump to be smaller, as the battery can be very small and run until the contact interface pressure is achieved or it is depleted of its energy (FIG. 7). The relatively low contact interface pressures required also allow small pumps to be employed. EXAMPLE

[0149] Exemplary assemblies, devices, methods, and systems as disclosed herein were assessed in a laboratory setting, to validate feasibility and functionality, as well as to verify any updates or improvements made.

[0150] Test specimens of the vacuum activated, interface pressure enhanced defibrillator pads were prepared, and Transthoracic Impedance (TTI) was measured on healthy subjects. Test specimen construction was based on the embodiment shown in FIGS. 24 and 25. TTI was measured using an excitation frequency of 32.8kHz. A Thomas Rotary Vane Pump, G 07, was used to provide a vacuum source. Pads were applied to the subject without vacuum so that TTI could be measured under typical conditions that would currently be achieved in a defibrillation setting. Vacuum was then applied so that TTI and vacuum could be graphed versus time, giving a plot of the impedance reduction as a function of vacuum. The application of the vacuum was controlled with a vacuum regulator, SMC model IRV10. Vacuum was then released to see if the TTI would return to the pre-interface pressure enhanced TTI, if the TTI would remain at the interface pressure enhanced level, or if some other result were found.

[0151] A schematic representative plot of Ohms and vacuum vs time is shown in Figure 21A. It can be seen that when vacuum was released, the impedance remained at the enhanced level, supporting the embodiments where differential pressure does not need to be maintained after adequate impedance reduction is achieved. Table 2 shows typical results that were achieved on a number of test subjects (healthy subjects).

[0152] Table 2: Impedance Reduction for Healthy Subjects

[0153] Starting Impedance represents the impedance measured once the device or defibrillator electrode assembly was placed on the subject, but prior to the application of a vacuum. Ending Impedance represents the impedance measured after the vacuum was applied. Regarding test subject 2, it is believed that the reason for low impedance reduction (4%) as compared to another data point for the same test subject 2 (e.g. impedance reduction of 34%) is due to the manner in which electrode was applied to test subject 2. In particular, the test device or assembly was applied to subject 2 after another electrode was previously applied to subject 2 at same location, such that residue from the another electrode previously applied remained on the subject at the same location.

[0154] Surprisingly, through tests with this embodiment, TTI reduction of 20% to 30% are not unusual. As the starting impedance is dependent on the quality of application of the device or the defibrillator electrode assembly, the invention herein is of particular benefit because AED users may have marginal training and experience. It can be seen in the graph (FIGS. 21A and 21B) that the amount of time required for differential pressure to be applied until the desired results are achieved can be quantified. For example, in the graph, a differential pressure applied for approximately 10 to 20 seconds is adequate to achieve most of the impedance reduction. A faster application of differential pressure has the potential to reduce this time.

[0155] Referring now to FIG. 21B, data is illustrated for an example using an embodiment of the defibrillator electrode assembly corresponding to FIG. 24. In this example, the data illustrates that when vacuum is held at ~ Ipsi, there is a substantial reduction in impedance. In this example, vacuum was applied at 10 seconds after the initiation of testing. At that time, the impedance was approximately 138 ohms. Then, a vacuum of approximately 1 psi was applied to the defibrillator electrode assembly for slightly more than 10 seconds until about the 22ndsecond of the test. In that 10 second period during which approximately 1 psi was applied to the defibrillator electrode assembly, the impedance was reduced from approximately 138 ohms to approximately 110 ohms, representing a substantial reduction of impedance of approximately 20%. The vacuum applied to the defibrillator electrode assembly was then increased from about 1 psi to almost 12 psi and, at about 55 seconds into the test, the vacuum was released. Surprisingly, the beneficial reduction of impedance was achieved with only about 1 psi of vacuum, and the beneficial reduction of impedance was maintained even after the vacuum was released.

[0156] This data indicates that low levels of patient-to-electrode contact pressure enhancement (e.g., 1 psi of vacuum) provide substantial reduction in impedance. It also indicates that only a short duration (e.g., 10 seconds of time) of patient-to- electrode contact pressure enhancement is required.

[0157] In general, the inventive device or assembly is configured to be positioned on or against the skin 1000a of a subject 1000 (e.g., as shown in embodiment illustrated in FIG. 11B). Specially, as shown in FIG. 1, the exemplary device or assembly, as will be described below, are positionable for placement proximate to a location on the subject 1000 (e.g. a chest or a back of the subject 1000), and multiple exemplary devices or assemblies may be placed proximate the chest, back, or combination thereof the subject 1000, such that the multiple exemplary devices or assemblies are configured to form part of a circuit to apply electrical energy to the subject 1000. The exemplary device or assembly described herein may have a generally rectangular geometry, as illustrated in FIG. 1, but is not so limited to specific geometries or profiles. Rather, as will be explained below, the exemplary device or assembly may be configured to conform to a desired anatomy of the subject 1000.

[0158] The invention generally relates to exemplary devices or assemblies that improve the contact pressure between a defibrillator electrode pad and a patient's skin 1000a, thereby reducing impedance during defibrillation and cardioversion. The exemplary device or assembly improves the contact pressure between a defibrillator electrode pad and a patient's skin 1000a by way of improvements in both the electrical coupling and physical coupling of the defibrillator electrode to the patient 1000. Electrical coupling relates to the resulting electrical impedance of a defibrillator system including the patient and / or the interface between the defibrillator electrode and the patient. Physical coupling relates to the quality and completeness of the physical contact between the patient 1000 and the defibrillator electrode pad. Additional details of the exemplary devices and assemblies will now be described below. Similar reference numbers are used for similar functional components in various embodiments discussed below.

[0159] In a first exemplary embodiment, a defibrillator electrode assembly is configured to reduce impedance when the defibrillator electrode assembly is applied to a patient. In this embodiment, an example of which is depicted in FIG. 24, a space to which a vacuum can be applied is integrated into the defibrillator electrode assembly, such that the space becomes enclosed by a vacuum barrier of the defibrillator electrode assembly and the skin of the patient when the integrated defibrillator electrode assembly is applied to the skin of the patient.

[0160] The defibrillator electrode assembly of this embodiment has a defibrillator electrode, a vacuum barrier coupled to the defibrillator electrode, and a sealing surface associated with the vacuum barrier. The vacuum barrier at least partially defines a space adjacent the defibrillator electrode. The sealing surface is configured for coupling the vacuum barrier relative to the patient such that when the vacuum barrier is coupled relative to the patient, the vacuum barrier is configured to create at least one chamber together with the patient and to resist the flow of the fluid into or out from the chamber. The defibrillator electrode assembly is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient.

[0161] With reference generally to the figures, various exemplary embodiments of the invention will be described in greater detail. First, reference will be made to the exploded view of the embodiment depicted in FIG. 24, which shows a defibrillator electrode assembly having a defibrillator electrode, a vacuum barrier coupled to the defibrillator electrode, and a sealing surface associated with the vacuum barrier, such that defibrillator electrode assembly is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient. Also, references will be made to embodiments depicted in FIGS. 1-23, particularly with FIGS. 5, 6, 13, 14A- 14B, and 20.

[0162] FIG. 24 depicts an exploded view of an exemplary defibrillator electrode assembly 100 configured to reduce impedance when the defibrillator electrode assembly 100 is applied to a patient 1000 in accordance with aspects of the invention. In an exemplary embodiment, the defibrillator electrode assembly 100 includes an adhesive 130, an electrolyte gel adhesive 112, an electrode 114, a lead wire 102, an electrode carrier 170, a vacuum seal 180, a distribution media 160, a fluid port 140, and a vacuum barrier 120. Additional details of the components or layers of the defibrillator electrode assembly 100 will now be discussed below.

[0163] In general, the defibrillator electrode assembly 100 has a defibrillator electrode 114, a vacuum barrier 120 coupled to the defibrillator electrode 114, and a sealing surface associated with the vacuum barrier 120. The defibrillator electrode assembly 100 is configured to conform to contours of an anatomy (e.g. chest, side, and / or back, for example) of the patient 1000. Additionally or optionally, the defibrillator electrode assembly 100 is configured for use for at least one of defibrillation, cardioversion, pacing, electrocardiograms, ECG, the diagnosis of cardiac arrythmias, monitoring of cardiac arrythmias, pacing of cardiac arrythmias, or treatment of cardiac arrythmias.

[0164] In an exemplary embodiment, the defibrillator electrode assembly 100 includes the adhesive 130, which is an optional adhesive member intended to limit the user's access to the defibrillation energy. Non-limiting examples of the adhesive 130 includes at least one of a pressure sensitive adhesive, a double-sided tape, a biocompatible adhesive, a hydrogel, a hydrocolloid, and an acrylic. The adhesive 130 is configured to be adhered to the patient 1000.

[0165] In an exemplary embodiment, the defibrillator electrode assembly 100 includes the sealing surface relative to the patient. The sealing surface comprises an electrolyte gel adhesive 112 (e.g., as shown in the embodiment illustrated in FIG. 6 in which the sealing surface 112 comprises adhesive and electrolyte). The electrolyte gel adhesive 112 is configured for directly or indirectly coupling one or more components or layers of the defibrillator electrode assembly 100 relative to the patient 1000.

[0166] In various exemplary embodiments, the adhesive 112 can be at least one of a gel, a hydrogel, a hydrocolloid, and can include a conductive electrolyte. In an exemplary embodiment, the sealing surface 112 creates a vacuum seal to the patient 1000 and provides electrical coupling between the patient 1000 and the electrode 114.

[0167] In an exemplary embodiment, the defibrillator electrode assembly 100 includes an electrode 114 adjacent to the adhesive electrolyte gel 112. The electrode 114 comprises a highly conductive surface and spreads the electrical energy across an adequate surface area when the defibrillator electrode assembly 100 is applied to the patient 1000.

[0168] In an exemplary embodiment, the defibrillator electrode assembly 100 includes a lead wire 102 which connects the defibrillator electrode assembly 100 to the defibrillator (not shown). Additionally or optionally, a vacuum seal 180 is formed between vacuum barrier 120 and an electrode carrier 170, but one skilled in the art would understand from the description herein that the vacuum seal 180 may be omitted such that a seal is directly formed between the vacuum barrier 120 and the electrode carrier 170 (e.g. via thermal welding or RF welding, etc.) In an exemplary embodiment, the electrode carrier 170 is coupled to the defibrillator electrode 114. The electrode carrier 170 is generally made from an electrically insulative material, including but not limited to a polymer film, sheet, or foam.

[0169] Turning now to FIG. 20, the vacuum barrier 120 at least partially defines a space 124 (e.g., as illustrated in the embodiments shown in FIGS. 13, 14A-14B, and 20) adjacent the defibrillator electrode 114. In an exemplary embodiment, the vacuum barrier 120 is configured to be directly or indirectly coupled to the patient 1000. Additionally or optionally, the sealing surface is configured for directly or indirectly coupling the vacuum barrier 120 to the patient 1000. The sealing surface 112 is configured for sealing the defibrillator electrode assembly 100 relative to the patient 1000, such that when the defibrillator electrode assembly 100 is sealed relative to the patient 1000, the vacuum barrier 120 is configured to create at least one chamber 126 together with the patient 1000 and to resist the flow of fluid into or out from the at least one chamber 126. The defibrillator electrode assembly 100 is configured to reduce the impedance as a vacuum is created in the space 124 to urge the defibrillator electrode 114 toward the patient 1000 when the defibrillator electrode assembly 100 is applied to the patient 1000 (e.g. patient skin 1000a). Referring to FIGS. 20 and 24, the defibrillator electrode assembly 100 includes at least one path or passageway 190 associated with the space 124 that is configured to remain open to allow fluid in and out from the space 124. Additionally or optionally, the path 190 comprises a plurality of openings 191, the plurality of openings 191 comprising but not limited to a slot, a hole, a channel, a cut-away, a slit, a notch, an aperture, an opening, fissures, air permeable material, or any combination thereof in any number, configuration or geometries. The path 190 is formed, such as when the plurality of openings 191 formed in at least the electrolyte gel adhesive 112 and electrode carrier 170 are aligned when the defibrillator electrode assembly 100 is assembled (as shown in the embodiment illustrated in FIG. 20), so that the at least one fluid path or passageway 190 forms a contiguous chamber to be created with the skin 1000a of the patient 1000 when the defibrillator electrode assembly 100 is coupled to the patient 1000. In this configuration, fluid from the contiguous chamber can be evacuated in a manner that urges the electrode 114 toward the patient 1000. Additionally or optionally, the at least one path or passageway 190 can also be formed in the electrode 114, and any other desired component or layer of defibrillator assembly 100, such that a contiguous chamber is formed when defibrillator electrode assembly 100 is coupled with the patient 1000. The shape, profile, location, and number of the plurality of openings 191 forming the at least one path or passageway 190 are not limited to those shown in the figures; rather, one skilled in the art would understand from the description herein that the shape, profile, location, and number of the plurality of openings 191 can vary relative to each other and relative to the other layers of the defibrillator electrode assembly 100 (e.g. use slots in one layer and holes in another layer), without departing form the scope of the invention.

[0170] Additionally or optionally, the path is provided, at least in part, by distribution media 160 positioned in the space 124 or on a surface defining the space 124. Nonlimiting examples of distribution media (e.g., as shown in embodiments illustrated in FIGS. 18A-18B) may be selected from the group consisting of (but not limited to) an embossed film, a gauze, a screen, channels, a hair-cell texture, beads, open cell foam, pillars, stand-offs, batting, a textured surface, a surface finish, or combinations thereof. The distribution media 160 allows fluid to be evacuated from the space 124 without the space 124 becoming blocked or pinching off. This can also be accomplished by providing features such as adding texture to surfaces of one or more of the existing layers of the defibrillator electrode assembly 100, including the electrode carrier 170.

[0171] Additionally or optionally, the defibrillator electrode assembly 100 also includes a port 140 configured to allow the flow of fluid into, out from, or into and out from the space 124 (e.g., as illustrated in the embodiments shown in FIGS. 13, 14A-14B, and 20). The port 140 may further be configured for fluid communication with a multilumen conduit having parallel axes or coaxial lumens. In this configuration, the defibrillator electrode assembly 100 may have the lead wire 102 coupled to the defibrillator electrode 114 and the lead wire 102 may be positioned within a lumen of the multi-lumen conduit. Additionally or optionally, the defibrillator electrode assembly 100 includes a valve (e.g. check valve 152 and / or a relief valve 154 as illustrated in the embodiments shown in FIGS. 4A-4B) configured to selectively permit flow of the fluid into, out from, or into and out from the space 124, such that the space 124 can be brought to or maintained at the vacuum.

[0172] To achieve this, a vacuum and / or pressure source 192 (e.g., as illustrated in the embodiment shown in FIGS. 7 and 8) is provided. In an exemplary embodiment, the vacuum source 192 is integral with the defibrillator electrode assembly 100 (e.g., as illustrated in the embodiment shown in FIG. 8). In another exemplary embodiment, the vacuum source 192 is a separate unit relative to the defibrillator electrode assembly 100 (e.g., as illustrated in the embodiment shown in FIG. 7). Alternatively, the vacuum source 192 can be coupled to the defibrillator pads 310, can be integrated into the pads 310 or overlay 128 (discussed in other embodiments below), can be strapped to the patient's 1000 arm, can be hung from medical equipment (e.g. IV bag holder), may be coupled to a stand, or may be part of the physical plant of the clinical facility, etc. In an exemplary embodiment, the vacuum source 192 may be integrated with a defibrillator. For example, the vacuum source, such as a vacuum pump, may be incorporated with or into an automated external defibrillator (AED). The vacuum and / or pressure source 192 may be coupled to one or more defibrillator electrode assemblies 100 via conduit 195 (and optionally, a fitting 196 configured to enable coupling to multiple components), may be battery-powered 193, include a display 194, include an indicator 197 (visual, audible, etc.) to indicate characteristics related to at least one of pressure, vacuum, and heat applied to the patient 1000 via the exemplary embodiments of devices and assemblies discussed herein, and include a controller configured to communicate to an external device via wired or wireless systems. Alternatively, the vacuum and / or pressure source 192 (or pressure differential source 192) may be activated or deactivated (turned on and off) based on the activated / deactivated status of another device associated with the exemplary embodiments of devices and assemblies discussed herein (e.g. defibrillator, etc.).

[0173] In an exemplary embodiment, the defibrillator electrode assembly 100 is configured to maintain a vacuum in the space 124 between 0.25 psi gauge and full vacuum, preferably greater than 0.25 psi and less than 5 psi, and more preferably greater than 0.25 psi and less than 2 psi. Additionally or optionally, the defibrillator electrode assembly 100 includes a source of differential pressure. Non-limiting examples of the source of differential pressure may be selected from the group consisting of a manual or electric or piezoelectric pump, a chemical reaction, a gas cartridge, hospital room fluids, a port for oral pressure or suction, a venturi, and combinations thereof. Additionally or optionally, the defibrillator electrode assembly 100 includes a differential pressure sensor. Additionally or optionally, the defibrillator electrode assembly 100 includes a source of heat (e.g. a heating element 320 as shown the embodiment illustrated in FIGS. 3A-3B) positioned to transfer heat to the defibrillator electrode assembly 100. Non-limiting examples of the source of heat may be from the group consisting of an electrical heater, a warm fluid, or a chemical reaction.

[0174] In a second exemplary embodiment, a defibrillator electrode assembly is configured to reduce impedance when the defibrillator electrode assembly is applied to a patient. In this embodiment, an example of which is depicted in FIG. 26, a chamber, which defines a space to which a pressure can be applied, is integrated into the defibrillator electrode assembly, such that the chamber is enclosed by a pressure barrier of the defibrillator electrode assembly.

[0175] The defibrillator electrode assembly of this embodiment has a defibrillator electrode, at least one chamber adjacent the defibrillator electrode, and a coupling surface. The at least one chamber is configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure. The coupling surface includes an adhesive configured for directly or indirectly coupling the at least one chamber relative to the patient. The defibrillator electrode assembly is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient and the fluid in the chamber is at the pressure.

[0176] With reference generally to the figures, various exemplary embodiments of the invention will be described in greater detail. First, reference will be made to the exploded view of the embodiment depicted in FIG. 26, which shows an exemplary embodiment of a defibrillator electrode assembly has a defibrillator electrode, at least one chamber adjacent the defibrillator electrode, and a coupling surface, such that the defibrillator electrode assembly is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient and the fluid in the chamber is at the pressure. Also, references will be made to embodiments depicted in FIGS. 1-23, particularly FIGS. 5, 6, 12, 14A-14B, and 15A-15B. FIG. 26 depicts an exploded view of another embodiment of a defibrillator electrode assembly configured to reduce impedance when the defibrillator electrode assembly is applied to a patient in accordance with aspects of the invention. The defibrillator electrode assembly, such as defibrillator electrode assembly 200, is similar in several respects to defibrillator electrode assembly 100 as described above. For example, the components of defibrillator electrode assembly 200 generally correspond to those of the embodiment(s) described above. The defibrillator electrode assembly 200 is configured to conform to contours of an anatomy (e.g. chest, side, and / or back) of the patient 1000. Additionally or optionally, the defibrillator electrode assembly 200 is configured for use for at least one of defibrillation, cardioversion, pacing, electrocardiograms, ECG, the diagnosis of cardiac arrythmias, monitoring of cardiac arrythmias, pacing of cardiac arrythmias, or treatment of cardiac arrythmias. Still further, the defibrillator electrode assembly 100 includes a differential pressure sensor.

[0177] However, defibrillator electrode assembly 200 can differ in some respects, as will be discussed below.

[0178] In general, a defibrillator electrode assembly 200 is configured to reduce impedance when the defibrillator electrode assembly 200 is applied to a patient 1000. The defibrillator electrode assembly 200 has a defibrillator electrode 114, at least one chamber 126 (e.g., as shown in the embodiments illustrated in FIG. 12) adjacent the defibrillator electrode 114, and a coupling surface 132. The defibrillator electrode assembly 200 is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode 114 toward the patient 1000 when the defibrillator electrode assembly 200 is applied to the patient 1000 and the fluid in the at least one chamber 126 is at the pressure. In an exemplary embodiment, as shown in FIG. 26, the defibrillator electrode assembly 200 includes an electrolyte 134, an electrode 114, a lead wire 102, a coupling surface 132, at least one chamber 126 having an outer layer 126b and an inner layer 126a, a fluid port 140, and optionally, a relief valve 154. In an exemplary embodiment, a chemical 142 can be optionally provided for to create the pressure, in which case the port 140 is optional. Additional details of the components or layers of the defibrillator electrode assembly 200 will now be discussed below.

[0179] In an exemplary embodiment, the electrolyte 134 is adjacent the electrode 114 and the electrolyte 134 includes at least one of a gel, paste, cream, liquid, adhesive, a hydrogel, and a hydrocolloid. The electrolyte 134 provides electrical coupling between the patient 1000 and the electrode 114. Additionally or optionally, the electrolyte 134 is an electrolyte adhesive. In an exemplary embodiment, the lead wire 102 connects the defibrillator electrode assembly 100 to the defibrillator (not shown). Additionally or optionally, the electrode 114 is indirectly or directly coupled to the at least one chamber 126.

[0180] In an exemplary embodiment, the coupling surface includes an adhesive 132 configured for directly or indirectly coupling the at least one chamber 126 relative to the patient 1000. Non-limiting examples of the adhesive 132 include at least one of a pressure sensitive adhesive, a double-sided tape, a biocompatible adhesive, a hydrogel, a hydrocolloid, an acrylic, a conductive adhesive, and an electrolyte adhesive. A decoupling force is required to remove the coupling surface comprising adhesive 132 from the patient 1000 and a contact force is generated by fluid in the at least one chamber 126 when the fluid in the at least one chamber 126 is at the pressure. The contact force is less than the decoupling force such that the defibrillator electrode assembly 200 does not become decoupled from the patient 1000 when the fluid in the at least one chamber 126 is at the pressure. In an exemplary embodiment, the coupling surface comprising the adhesive 132 resists the decoupling force generated by the pressurized fluid in the at least one chamber 126. In a non-limiting example, both the coupling surface comprising the adhesive 132 and electrolyte 134 (with electrolyte 134 being optionally an electrolyte adhesive) resist the decoupling force generated by the pressurized fluid in the at least one chamber 126. Additionally or optionally, the coupling surface comprising the adhesive 132 and electrolyte 134 may be integrally formed as a unitary component to resist the decoupling force generated by the pressurized fluid in the at least one chamber 126.

[0181] Turning to FIG. 12, for example, the at least one chamber 126 comprises the outer layer 126b and the inner layer 126a, such that when the outer layer 126b is sealed to the inner layer 126a, a bladder is formed to create the at least one chamber 126. Thus, the at least one chamber 126 defines a space 124 (e.g. as illustrated in the embodiments shown in FIGS. 12 and 14A-14B) for receiving the fluid. In an exemplary embodiment, the at least one chamber 126 is configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber 126 under pressure. Additionally or optionally, the inner layer 126a comprises a film, a sheet, a foam, or a combination thereof. Additionally or optionally, the defibrillator electrode assembly 200 includes a chemical or multi-part chemical 142 (e.g. as shown in the embodiment illustrated in FIG. 26), which can be activated to inflate the pressure bladder or chamber 126. For example, a two-part chemical may be activated by breaking a seal with a user's hand. Additionally or optionally, the chemical 142 may also be used to heat the defibrillator electrode assembly 200. Additionally or optionally, the at least one chamber 126 is segmented or baffled (e.g., as shown in the embodiments illustrated in FIGS. 15A-15B and 16A-16B). In this way, the at least one chambers 126 are configured to flex relative to one another to conform to contours of the anatomy of the patient 1000, as shown in FIG. 17.

[0182] In an exemplary embodiment, the defibrillator electrode assembly 200 is configured to generate or maintain a pressure in the at least one chamber 126 greater than 0.25 psi. In one non-limiting example, the defibrillator electrode assembly 200 is configured to maintain a pressure in the at least one chamber 126 between 0.25 psi and 5 psi. Additionally or optionally, the defibrillator electrode assembly 200 is configured to maintain a pressure in the at least one chamber 126 greater than 0.25 psi and less than 2 psi.

[0183] In an exemplary embodiment, to maintain a pressure in the at least one chamber 126, the defibrillator electrode assembly 200 includes a source of differential pressure (e.g. source 192 as illustrated in the embodiment shown in FIGS. 7-8). The source of differential pressure 192 may be selected from the group consisting of (but not limited to) a manual or electric or piezo-electric pump, a chemical reaction, a gas cartridge, hospital room fluids, a port for oral pressure or suction, a venturi, and combinations thereof.

[0184] Additionally or optionally, the defibrillator electrode assembly 200 has a port 140 (as in the defibrillator electrode assembly 100 discussed above) configured to allow the flow of fluid into, out from, or into and out from the space 124. As in the defibrillator electrode assembly 100, the port 140 of the defibrillator electrode assembly 200 may be configured for fluid communication with a multi-lumen conduit having parallel axes or coaxial lumens. Additionally or optionally, the defibrillator electrode assembly 200 includes at least one valve (e.g., a check valve 152 and / or a relief valve 154 as shown in the embodiments illustrated in FIGS. 4A-4B) configured to selectively permit the flow of fluid into, out from, or into and out from the space 124 such that the space 124 can be brought to or maintained at the pressure. Non-limiting examples of the at least one valve may be selected from the group consisting of (but not limited to) a check valve 152, a relief valve 154, a stopcock, a clamp, a hemostat, and combinations thereof. The relief valve 154 is configured to allow the flow of the fluid out from the space 124 (e.g. relief valve 154 is configured to vent any excess pressure that may be created or supplied by a fluid pump, a chemical reaction, or by other means known in the art). The port 140 is optional when the pressure is generated internal to the chamber 126. As shown in FIG. 26, for example, the relief valve 154 is illustrated as being attached to the outer layer 126b. However, the relief valve 154 could be alternatively coupled to other components of the defibrillator electrode assembly 200, including but not limited to a conduit or tube 500 (e.g., as shown in the embodiments illustrated in FIGS. 4A-4B), or the port 140. In a third exemplary embodiment, a device is configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient. In this embodiment, an example of which is depicted in FIG. 25, a space to which a vacuum can be applied is created by a device that is applied as an overlay to a defibrillator electrode to form a defibrillator electrode assembly, such that the space becomes enclosed by a vacuum barrier of the device and the skin of the patient when the device is overlayed over the defibrillator electrode and applied to the skin of the patient.

[0185] The device of this embodiment has a vacuum barrier and a sealing surface associated with the vacuum barrier. The vacuum barrier is configured to at least partially define a space adjacent the defibrillator electrode pad when the vacuum barrier is coupled to at least one of the defibrillator electrode pad and the patient. The sealing surface is configured for coupling the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient and to resist the flow of the fluid into or out from the space when the vacuum barrier is coupled relative to at least one of the defibrillator electrode pad and the patient. The device is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the sealing surface of the device couples the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the space is at the vacuum.

[0186] With reference generally to the figures, various exemplary embodiments of the invention will be described in greater detail. First, reference will be made to the exploded view of the embodiment depicted in FIG. 25, which shows a device having a vacuum barrier at least partially defining a space adjacent the defibrillator electrode pad when the vacuum barrier is coupled to at least one of the defibrillator electrode pad and the patient and a sealing surface configured for coupling the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient and to resist the flow of the fluid into or out from the space when the vacuum barrier is coupled relative to at least one of the defibrillator electrode pad and the patient, such that the device is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the sealing surface of the device couples the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the space is at the vacuum. Also, references will be made to embodiments depicted in FIGS. 1-23, particularly FIGS. 2, 9A-9C, 10A-10C, 11B, 22, and 23.

[0187] FIG. 25 depicts an exploded view of a device 300 configured for use with a defibrillator electrode pad 310 to reduce impedance when the defibrillator electrode pad 310 is applied to a patient 1000 in accordance with aspects of the invention. A kit comprising the device 300 and the defibrillator electrode pad 310 may be provided. In an exemplary embodiment, the device 300 includes a vacuum barrier 120 and a sealing surface 136 associated with the vacuum barrier 120. Additional details of the components or layers of the device 300 will now be discussed below.

[0188] Turning now to FIGS. 25 and 9A-9C, for example, in an exemplary embodiment, the vacuum barrier 120 is configured to at least partially define a space 124 adjacent the defibrillator electrode pad 310 when the vacuum barrier 120 is coupled to at least one of the defibrillator electrode pad 310 and the patient 1000. The device 300 is configured to reduce the impedance as a vacuum is created in the space 124 to urge the defibrillator electrode pad 310 toward the patient 1000 when the defibrillator electrode pad 310 is applied to the patient, such that the sealing surface 136 of the device 300 couples the vacuum barrier 120 relative to at least one of the defibrillator electrode pad 310 and the patient 1000, and the fluid in the space 124 is at the vacuum. Additionally or optionally, the device 300 is configured to conform to contours of an anatomy (e.g. chest, side, and / or back, for example) of the patient 1000.

[0189] In an exemplary embodiment, the sealing surface 136 is configured for coupling the vacuum barrier 120 relative to at least one of the defibrillator electrode pad 310 and the patient 1000. Additionally or optionally, the sealing surface 136 and the vacuum barrier 120 is separate from the defibrillator electrode pad 310. In this way, the sealing surface 136 is configured to couple the vacuum barrier 120 relative to at least one of the defibrillator electrode pad 310 and the patient 1000 before or after the defibrillator electrode pad 310 is applied to the patient 1000.

[0190] In an exemplary embodiment, as shown in FIGS. 2 and 10A-10C, for example, the device 300 is an overlay 128 configured to at least partially cover the defibrillator electrode pad 310. As shown in FIG. 2, the overlay 128 is additionally or optionally configured to partially cover the defibrillator electrode pad 310 without covering a lead or lead wire 102 (not shown) connected to the defibrillator electrode pad 310. Additionally or optionally, the overlay 128 is configured to fully cover the defibrillator electrode pad 310 and create the sealing surface 136 around a lead 102 connected to the defibrillator electrode pad 310. In an exemplary embodiment, the sealing surface 136 includes an adhesive hydrogel of low conductivity. The low conductivity adhesive hydrogel, not containing an additional electrolyte, for example.

[0191] In an exemplary embodiment, as shown in FIG. 11B, for example, the sealing surface 136 is configured to resist the flow of fluid into or out from the space 124 when the vacuum barrier 120 is coupled relative to at least one of the defibrillator electrode pad 310 and the patient 1000. In an exemplary embodiment, as shown in FIGS. 22 and 23, a lead wire 102 may be sealed in via a vacuum seal flap 600. Additionally or optionally, vacuum seal flap 600 comprises the same material as the sealing surface 136. One skilled in the art would understand from the description herein that additional components, materials, and layers may be added to that shown in FIG. 25, for example. For example, an adhesive 130 (as described above with respect to defibrillator electrode assembly 100) may be incorporated to allow for an electrical safety barrier and to allow one to easily remove the device 300. Other decoupling means such as pull tabs can also be incorporated in device 300 and in any of the embodiments of the defibrillator electrode assemblies, devices, methods, and systems described herein.

[0192] In another exemplary embodiment shown in FIG. 30, which depicts an exploded view of an exemplary embodiment of device 700. Device 700 is configured for use with a defibrillator electrode pad 310 to reduce impedance when the defibrillator electrode pad 310 is applied to a patient 1000 in accordance with aspects of the invention. A kit comprising the device 700 and the defibrillator electrode pad 310 may be provided.

[0193] In an exemplary embodiment, device 700 has a vacuum barrier 120 and a sealing surface 181 associated with the vacuum barrier 120. The vacuum barrier 120 is configured to at least partially define the space 124 adjacent the defibrillator electrode pad 310 when the vacuum barrier 120 is coupled to at least one of the defibrillator electrode pad 310 and the patient 1000. The device 700 is configured to reduce the impedance as a vacuum is created in the space 124 to urge the defibrillator electrode pad 310 toward the patient 1000 when the defibrillator electrode pad 310 is applied to the patient, such that the sealing surface 181 of the device 300 couples the vacuum barrier 120 relative to at least one of the defibrillator electrode pad 310 and the patient 1000, and the fluid in the space 124 is at the vacuum. Additionally or optionally, the device 700 is configured to conform to contours of an anatomy (e.g. chest, side, and / or back) of the patient 1000.

[0194] In an exemplary embodiment, the sealing surface 181 is configured for coupling the vacuum barrier 120 relative to at least one of the defibrillator electrode pad 310 and the patient 1000. Additionally or optionally, the sealing surface 181 and the vacuum barrier 120 is separate from the defibrillator electrode pad 310. In this way, the sealing surface 181 is configured to couple the vacuum barrier 120 relative to at least one of the defibrillator electrode pad 310 and the patient 1000 before or after the defibrillator electrode pad 310 is applied to the patient 1000.

[0195] The sealing surface 181 is configured to resist the flow of fluid into or out from the space 124 when the vacuum barrier 120 is coupled relative to at least one of the defibrillator electrode pad 310 and the patient 1000. In an exemplary embodiment, the sealing surface 181 comprises an adhesive sheet that covers up to an entirety of a patient-facing surface (e.g. outermost surface proximal to the patient 1000) of the device 700, providing that at least one opening 191 is present for vacuum. The sealing surface 181 provides a seal, together with an outer perimeter of the vacuum barrier 120, such that when device 700 is coupled to the patient 1000 and / or the defibrillator electrode pad 310, at least one chamber 126 is formed. In an exemplary embodiment, the sealing surface 181 includes a plurality of openings 191 forming plural passageways 190 which form a fluid communication with the distribution media 160 such that creation of vacuum is facilitated in the space 124 to urge the defibrillator electrode pad 310 toward the patient 1000. It is understood that the sealing surface 181 may be comprised of materials similar or the same as those of sealing surface 136.

[0196] In a fourth exemplary embodiment, a device is configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient. In this embodiment, an example of which is depicted in FIG. 27, a chamber to which a pressure can be applied is provided by a device that is applied as an overlay to a defibrillator electrode to form a defibrillator electrode assembly, such that the defibrillator electrode is interposed between the chamber of the device and the skin of the patient when the device is overlayed over the defibrillator electrode and adhered to the skin of the patient.

[0197] The device of this embodiment has at least one chamber configured to be positioned adjacent the defibrillator electrode pad and a coupling surface. The at least one chamber is configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure. The coupling surface is configured for positioning the at least one chamber relative to at least one of the defibrillator electrode pad and the patient. The device is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the coupling surface of the device positions the at least one chamber relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the chamber is at the pressure.

[0198] With reference generally to the figures, various exemplary embodiments of the invention will be described in greater detail. First, reference will be made to the exploded view of the embodiment depicted in FIG. 27 , which shows a device having at least one chamber configured to be positioned adjacent the defibrillator electrode pad and configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure, the device also having a coupling surface configured for positioning the at least one chamber relative to at least one of the defibrillator electrode pad and the patient, such that the device is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the coupling surface of the device positions the at least one chamber relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the chamber is at the pressure. Also, references will be made to embodiments depicted in FIGS. 1-23, particularly FIGS. 10A-10C, 11A, and 15A-15B.

[0199] FIG. 27 is an exploded view of a device 400 configured for use with a defibrillator electrode pad 310 to reduce impedance when the defibrillator electrode pad 310 is applied to a patient 1000 in accordance with aspects of the invention. A kit comprising the device 400 and the defibrillator electrode pad 310 may be provided.

[0200] The device 400 may include components with details and operation thereof generally corresponding to those of the embodiments discussed above, including device 300 and defibrillator electrode assembly 200. However, device 400 can differ in some respects, as will be made clearer below. Additionally or optionally, the device 400 is configured to conform to contours of an anatomy (e.g. chest, side, and / or back) of the patient 1000.

[0201] In general, the device 400 has at least one chamber 126 configured to be positioned adjacent the defibrillator electrode pad 310 and a coupling surface . The at least one chamber 126 having an inner layer 126a and an outer layer 126b is configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber 126 under pressure. The device 400 is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode pad 310 toward the patient 1000 when the defibrillator electrode pad 310 is applied to the patient 1000, the coupling surface of the device 400 positions the at least one chamber 126 relative to at least one of the defibrillator electrode pad 310 and the patient 1000, and the fluid in the at least one chamber 126 is at the pressure. Additionally or optionally, the at least one chamber 126 is segmented or baffled (e.g., as shown in the embodiments illustrated in FIGS. 15A-15B). In this way, the at least one chambers 126 are configured to flex relative to one another to conform to contours of the anatomy of the patient 1000, as shown in FIG. 17.

[0202] Turning now to FIGS. 7 and 11A, the coupling surface comprising the adhesive 132 is configured for positioning the at least one chamber 126 relative to at least one of the defibrillator electrode pad 310 and the patient 1000. The coupling surface comprising the adhesive 132 and the at least one chamber 126 are separate from the defibrillator electrode pad 310, with the coupling surface comprising the adhesive 132 being configured to couple the at least one chamber 126 relative to at least one of the defibrillator electrode pad 310 and the patient 1000 before or after the defibrillator electrode pad 310 is applied to the patient 1000. In an exemplary embodiment, the at least one chamber 126 and the coupling surface comprising the adhesive 132 together form the overlay 128 configured to at least partially cover the defibrillator electrode pad 310, as shown in FIGS. 10A-10C. Additionally or optionally, the overlay 128 is configured to partially cover the defibrillator electrode pad 310.

[0203] Still further, a decoupling force is required to remove the coupling surface comprising the adhesive 132 from the patient 1000 and a contact force is generated by fluid in the at least one chamber 126 when the fluid in the at least one chamber 126 is at the pressure, and wherein the contact force is less than the decoupling force. In this way, the coupling surface comprising the adhesive 132 is configured to resist the decoupling force generated by the pressurized fluid in the at least one chamber 126. In an exemplary embodiment, the coupling surface comprising the adhesivel32 comprises an adhesive coupled to the inner layer 126a of the at least one chamber 126. The coupling surface comprising the adhesive 132 may cover a portion of the inner layer 126a (e.g. placed around a perimeter of the at least one chamber 126 as shown in the embodiment illustrated in FIG. 27), or it may cover an entirety of a surface defined by the inner layer 126a. In this way, the coupling surface comprising the adhesive 132 is similar to the coupling surface 136 (discussed above) in that the coupling surface comprising the adhesive 132 includes an adhesive configured for directly or indirectly coupling the at least one chamber 126 relative to the patient 1000. Non-limiting examples of the coupling surface comprising the adhesive 132 includes at least one of a pressure sensitive adhesive, a double-sided tape, a biocompatible adhesive, a hydrogel, a hydrocolloid, an acrylic, a conductive adhesive, and an electrolyte adhesive.

[0204] Turning now to FIG. 28, an exemplary method 1100 of configuring a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient, is provided. In an exemplary embodiment, method 1100 is described in context of one or more of the defibrillator electrode assemblies 100, 200 and devices 300, 400, 700 as discussed above. Generally, method 1100 includes: step 1110 of positioning a differential pressure barrier adjacent the defibrillator electrode pad to at least partially define a space adjacent the defibrillator electrode pad; step 1120 of adhering the defibrillator electrode pad on the patient; and step 1130 of forming a chamber to resist the flow of a fluid into or out from the space.

[0205] In an exemplary embodiment, step 1110 includes positioning a differential pressure barrier (e.g. vacuum barrier 120, chamber 126, etc.) adjacent the defibrillator electrode pad 310 to at least partially define a space 124 adjacent the defibrillator electrode pad 310. Additionally or optionally, positioning the differential pressure barrier includes partially or fully covering the defibrillator electrode pad 310 with the differential pressure barrier. Still further, step 1110 includes sealing around a lead wire 102 connected to the defibrillator electrode pad 310. Alternatively, step 1110 avoids covering a lead wire 102 connected to the defibrillator electrode pad 310.

[0206] In an exemplary embodiment, step 1120 includes adhering the defibrillator electrode pad 310 on the patient 1000. Additionally or optionally, step 1120 is performed before or after step 1110.

[0207] In an exemplary embodiment, step 1130 includes forming a chamber 126 to resist the flow of a fluid into or out from the space 124. Additionally or optionally, step 1130 of forming the chamber 126 to resist the flow of a fluid into or out from the space 124 is performed such that the impedance can be reduced as positive or negative pressure of the fluid in the chamber 126 urges the defibrillator electrode pad 310 toward the patient when the fluid in the chamber 126 is at the positive or negative pressure. In this way, method 1200 includes a step of generating a pressure in the chamber 126 to increase the contact force between the defibrillator electrode pad 310 and the patient 100 without exceeding a decoupling force required to remove the differential pressure barrier from the patient 1000. In a non-limiting example, the step of generating of the pressure in the chamber 126 includes generating greater than 0.25 psi and less than 3 psi. In another non-limiting example, step 1130 of forming the chamber 126 includes defining the chamber 126 by the differential pressure barrier and the patient 1000. In yet another non-limiting example, method 1200 includes a step of generating a vacuum in the chamber 126 greater than 0.25 psi gauge and less than full vacuum. Additionally or optionally, method 1100 includes a step of adhering the differential pressure barrier to the patient 1000.

[0208] Turning now to FIG. 29, an exemplary method 1200 for reducing impedance when a defibrillator electrode assembly is applied to a patient, is provided. In an exemplary embodiment, method 1200 is described in context of one or more of the defibrillator electrode assemblies 100, 200 and devices 300, 400, 700 as discussed above. Generally, method 1200 includes: step 1210 of applying the defibrillator electrode assembly to a patient; step 1220 of increasing or decreasing the pressure in a chamber positioned between a differential pressure barrier and a defibrillator electrode of the defibrillator electrode assembly; and step 1230 of reducing the impedance as positive or negative pressure in the chamber urges the defibrillator electrode toward the patient when fluid in the chamber is at the positive or negative pressure.

[0209] In an exemplary embodiment, step 1230 includes forming a chamber 126 to resist the flow of a fluid into or out from the space 124. Additionally or optionally, method 1200 includes a step of adhering the differential pressure barrier to the patient 1000, a step of forming the chamber 126 between the differential pressure barrier and the patient 1000, a step of generating a pressure in the chamber 126 to increase a contact force between the defibrillator electrode 110 and the patient 1000 without exceeding a decoupling force required to remove the differential pressure barrier from the patient 1000, and a step of generating a vacuum in the chamber 126 greater than 0.25 psi gauge and less than full vacuum. In an exemplary embodiment, the step of generating of the pressure in the chamber 126 includes generating greater than 0.25 psi gauge.

[0210] In an exemplary embodiment, a defibrillator system 2000 is configured to reduce impedance when applied to a patient 1000. In an exemplary embodiment, the system 2000 is described in context of at least one or more of the defibrillator electrode assemblies 100, 200 and devices 300, 400, 700 as discussed above. FIG. 14A depicts a first conduit 800 configured to be in fluid communication with a fluid port 140b to selectively permit flow of fluid into and / or out from a space 124 defined by an exemplary vacuum barrier 120 and a second conduit 500 in fluid communication with an exemplary chamber 126 and fluid port 140b to create positive or negative pressure in the chamber 126. FIG. 14B depicts a first chamber 126 formed in part by an exemplary vacuum barrier 120 to resist the flow of fluid into or out from the first chamber 126 and a second chamber 126 configured to resist the passage of a fluid and to maintain the fluid in the second chamber 126 under pressure in accordance with aspects of the invention.

[0211] The defibrillator system has a defibrillator electrode 114, a differential pressure barrier coupled to the defibrillator electrode 114, a coupling surface 132 associated with the differential pressure barrier, and a source 192 (e.g. as shown in the embodiments illustrated in FIGS. 7 and 8) of differential pressure associated with a chamber 126 to create positive or negative pressure in the chamber 126. Additionally or optionally, the system 2000 includes a switch 198 (e.g. as shown in the embodiment illustrated in FIG. 8) to actuate the source 192 of differential pressure. The differential pressure barrier at least partially defines a space 124 adjacent the defibrillator electrode 110. The coupling surface 182 is configured for coupling the differential pressure barrier relative to the patient 1000 such that the space 124 is contained in the chamber 126 adjacent the defibrillator electrode 110.

[0212] The defibrillator system 2000 is configured to reduce the impedance when the positive or negative pressure is created in the chamber 126 to urge the defibrillator electrode 110 toward the patient 1000 when the defibrillator system 2000 is applied to the patient 1000. Additionally or optionally, the defibrillator system 2000 includes an impedance sensor for sensing the impedance of the defibrillator system 2000 when the defibrillator system 2000 is applied to the patient 1000. In this way, the system 2000 includes a controller configured to: receive a signal corresponding to the impedance sensed by the impedance sensor and activate or deactivate the source of differential pressure when a selected impedance is sensed. Additionally or optionally, the controller is configured to monitor the impedance sensed by the impedance sensor continuously, periodically, or responsive to a command. As seen in the embodiments shown in FIGS. 7 and 8, for example, a visual or audible indicator 197 of impedance of the defibrillator system 2000 may be provided. The indicator 197 is configured to indicate that the system 2000 is ready for use for defibrillation.

[0213] In an exemplary embodiment, the system 2000 has a differential pressure sensor for sensing the positive or negative pressure in the chamber 126 of the defibrillator system, when the defibrillator system 2000 is applied to the patient 1000. As described above, the system 2000 has a visual or audible indicator 197 of differential pressure in the chamber 126, which may be the same as or different from the visual or audible indicator 197 of impedance of the defibrillator system 2000. Thus, in this way, the system includes a controller configured to: receive a signal corresponding to the pressure sensed by the pressure sensor and activate or deactivate or control the source of differential pressure when a selected pressure is sensed. Additionally or optionally, the system 2000 includes a controller coupled for communication of signals with the source of differential pressure. In a non-limiting example, this communication of signals is wireless.

[0214] In still another exemplary embodiment, as shown in FIGS. 19A-19B, a defibrillator paddle showing baffles to create multiple chambers in accordance with aspects of the invention is provided. The multiple chambers may be segmented and / or baffled to improve conformability to patients anatomy by permitting the segments or baffles of the multiple chambers to remains flexible when the fluid within the spaces defined therein are under pressure or at vacuum.

[0215] It has been discovered that, according to aspects of the invention, impedance of defibrillation electrodes can be reduced without the need for supplemental mechanisms such as belts, harnesses, straps, vests, jackets, or structures that wrap around the patient. According to embodiments of the invention, an intimate coupling of the defibrillation electrodes and devices described herein is sufficient to reduce impedance absent such supplemental mechanisms. For example, the application of differential pressure (whether positive pressure or vacuum) to a defibrillation electrode adhered or sealed to the skin of the patient is surprisingly sufficient to reduce impedance, thus eliminating the use of supplemental structures. This invention includes, but is not limited to, the following aspects:

[0216] Aspect 1. A defibrillator electrode assembly configured to reduce impedance when the defibrillator electrode assembly is applied to a patient, the defibrillator electrode assembly comprising: a defibrillator electrode; a vacuum barrier coupled to the defibrillator electrode and at least partially defining a space adjacent the defibrillator electrode; and a sealing surface associated with the vacuum barrier and configured for coupling the vacuum barrier relative to the patient such that when the vacuum barrier is coupled relative to the patient, the vacuum barrier is configured to create at least one chamber together with the patient and to resist the flow of fluid into or out from the chamber; wherein the defibrillator electrode assembly is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient.

[0217] Aspect 2. The defibrillator electrode assembly of claim 1 configured to conform to contours of an anatomy of the patient.

[0218] Aspect 3. The defibrillator electrode assembly of aspect 1, the sealing surface comprising an adhesive.

[0219] Aspect 4. The defibrillator electrode assembly of aspect 2, the adhesive comprising a conductive electrolyte.

[0220] Aspect 5. The defibrillator electrode assembly of aspect 2, the adhesive being conductive.

[0221] Aspect 6. The defibrillator electrode assembly of aspect 2, the adhesive comprising at least one of a hydrogel and a hydrocolloid.

[0222] Aspect 7. The defibrillator electrode assembly of aspect 1, the defibrillator electrode including an electrode adjacent to an electrolyte configured for electrically coupling the electrode to the patient.

[0223] Aspect 8. The defibrillator electrode assembly of aspect 1, further comprising a port configured to allow the flow of the fluid into, out from, or into and out from the space.

[0224] Aspect 9. The defibrillator electrode assembly of aspect 8, further comprising a valve configured to selectively permit the flow of the fluid into, out from, or into and out from the space such that the space can be brought to or maintained at the vacuum.

[0225] Aspect 10. The defibrillator electrode assembly of aspect 9, the valve being a check valve associated with the port. Aspect 11. The defibrillator electrode assembly of aspect 8, the port being configured for fluid communication with a multi-lumen conduit having parallel axes or coaxial lumens.

[0226] Aspect 12. The defibrillator electrode assembly of aspect 9, further comprising a lead wire coupled to the defibrillator electrode, the lead wire being associated with the multi-lumen conduit or within a lumen of the multi-lumen conduit.

[0227] Aspect 13. The defibrillator electrode assembly of aspect 1, further comprising a valve configured to relieve the vacuum in the space.

[0228] Aspect 14. The defibrillator electrode assembly of aspect 1 having at least one path associated with the space that is configured to remain open to allow fluid in and out from the space.

[0229] Aspect 15. The defibrillator electrode assembly of aspect 14, the at least one path being provided by the vacuum barrier having a textured surface.

[0230] Aspect 16. The defibrillator electrode assembly of aspect 14, the path being provided by distribution media positioned in the space or on a surface defining the space.

[0231] Aspect 17. The defibrillator electrode assembly of aspect 16, the distribution media being selected from the group consisting of an embossed film, a gauze, a screen, channels, a hair-cell texture, beads, open cell foam, pillars, stand-offs, batting, a textured surface, a surface finish, or combinations thereof.

[0232] Aspect 18. The defibrillator electrode assembly of aspect 1, the defibrillator electrode assembly being configured to maintain a vacuum in the space between 0.25 psi and full vacuum.

[0233] Aspect 19. The defibrillator electrode assembly of aspect 18, the defibrillator electrode assembly being configured to maintain a vacuum in the space greater than 0.25 psi and less than 5 psi.

[0234] Aspect 20. The defibrillator electrode assembly of aspect 18, the defibrillator electrode assembly being configured to maintain a vacuum in the space greater than 0.25 psi and less than 2 psi.

[0235] Aspect 21. The defibrillator electrode assembly of aspect 1, further comprising a source of differential pressure.

[0236] Aspect 22. The defibrillator electrode assembly of aspect 21, the source of differential pressure being selected from the group consisting of a manual or electric or piezo-electric pump, a chemical reaction, a gas cartridge, hospital room fluids, a port for oral pressure or suction, a venturi, and combinations thereof. Aspect 23. The defibrillator electrode assembly of aspect 1, further comprising a source of heat positioned to transfer heat to the defibrillator electrode assembly.

[0237] Aspect 24. The defibrillator electrode assembly of aspect 23, the source of heat being selected from the group consisting of an electrical heater, a warm fluid, or a chemical reaction.

[0238] Aspect 25. The defibrillator electrode assembly of aspect 1, the vacuum barrier being configured to be directly coupled to the patient.

[0239] Aspect 26. The defibrillator electrode assembly of aspect 25, the sealing surface being configured for directly coupling the vacuum barrier to the patient.

[0240] Aspect 27. The defibrillator electrode assembly of aspect 1, the at least one chamber being segmented or baffled.

[0241] Aspect 28. The defibrillator electrode assembly of aspect 1 being configured for use for at least one of defibrillation, cardioversion, pacing, electrocardiograms, ECG, the diagnosis of cardiac arrythmias, monitoring of cardiac arrythmias, pacing of cardiac arrythmias, or treatment of cardiac arrythmias.

[0242] Aspect 29. The defibrillator electrode assembly of aspect 1, further comprising a differential pressure sensor.

[0243] Aspect 30. A defibrillator electrode assembly configured to reduce impedance when the defibrillator electrode assembly is applied to a patient, the defibrillator electrode assembly comprising: a defibrillator electrode; at least one chamber adjacent the defibrillator electrode, the at least one chamber being configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure; and a coupling surface including an adhesive configured for directly or indirectly coupling the at least one chamber relative to the patient; wherein the defibrillator electrode assembly is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient and the fluid in the chamber is at the pressure.

[0244] Aspect 31. The defibrillator electrode assembly of aspect 30 configured to conform to contours of an anatomy of the patient.

[0245] Aspect 32. The defibrillator electrode assembly of aspect 30, wherein the at least one chamber defines a space for receiving the fluid.

[0246] Aspect 33. The defibrillator electrode assembly of aspect 32, wherein a decoupling force is required to remove the coupling surface from the patient and a contact force is generated by fluid in the chamber when the fluid in the chamber is at the pressure, and wherein the contact force is less than the decoupling force such that the defibrillator electrode assembly does not become decoupled from the patient when the fluid in the chamber is at the pressure.

[0247] Aspect 34. The defibrillator electrode assembly of aspect 30, the adhesive configured to couple the at least one chamber to the patient, the adhesive comprising at least one of a pressure sensitive adhesive, a double-sided tape, a biocompatible adhesive, a hydrogel, a hydrocolloid, an acrylic, a conductive adhesive, and an electrolyte adhesive.

[0248] Aspect 35. The defibrillator electrode assembly of aspect 30, further comprising an electrolyte adjacent the defibrillator electrode, the electrolyte comprising at least one of a gel, a hydrogel, a hydrocolloid, a paste, and a cream.

[0249] Aspect 36. The defibrillator electrode assembly of aspect 30, the electrolyte of aspect 35 comprising an adhesive.

[0250] Aspect 37. The defibrillator electrode assembly of aspect 30, further comprising a differential pressure sensor.

[0251] Aspect 38. The defibrillator electrode assembly of aspect 30, further comprising a port configured to allow the flow of the fluid into, out from, or into and out from the space.

[0252] Aspect 39. The defibrillator electrode assembly of aspect 30, further comprising at least one valve configured to selectively permit the flow of the fluid into, out from, or into and out from the space such that the space can be brought to or maintained at the pressure.

[0253] Aspect 40. The defibrillator electrode assembly of aspect 39, the at least one valve selected from the group consisting of a check valve, a relief valve, a stopcock, a clamp, a hemostat, and combinations thereof.

[0254] Aspect 41. The defibrillator electrode assembly of aspect 38, the port being configured for fluid communication with a multi-lumen conduit having parallel axes or coaxial lumens.

[0255] Aspect 42. The defibrillator electrode assembly of aspect 30, further comprising a relief valve configured to allow the flow of the fluid out from the space.

[0256] Aspect 43. The defibrillator electrode assembly of aspect 30, the defibrillator electrode assembly being configured to generate a pressure in the chamber greater than 0.25 psi.

[0257] Aspect 44. The defibrillator electrode assembly of aspect 30, the defibrillator electrode assembly being configured to maintain a pressure in the chamber greater than 0.25 psi. Aspect 45. The defibrillator electrode assembly of aspect 44, the defibrillator electrode assembly being configured to maintain a pressure in the chamber greater than 0.25 psi and less than 5 psi.

[0258] Aspect 46. The defibrillator electrode assembly of aspect 44, the defibrillator electrode assembly being configured to maintain a pressure in the chamber greater than 0.25 psi and less than 2 psi.

[0259] Aspect 47. The defibrillator electrode assembly of aspect 30, further comprising a source of differential pressure.

[0260] Aspect 48. The defibrillator electrode assembly of aspect 47, the source of differential pressure being selected from the group consisting of a manual or electric or piezo-electric pump, a chemical reaction, a gas cartridge, hospital room fluids, a port for oral pressure or suction, a venturi, and combinations thereof.

[0261] Aspect 49. The defibrillator electrode assembly of aspect 30, the at least one chamber being segmented or baffled.

[0262] Aspect 50. The defibrillator electrode assembly of aspect 49, the chambers being configured to flex relative to one another to conform to contours of the anatomy of the patient.

[0263] Aspect 51. The defibrillator electrode assembly of aspect 30 being configured for use for at least one of defibrillation, cardioversion, pacing, electrocardiograms, ECG, diagnosis of cardiac arrythmias, monitoring of cardiac arrythmias, pacing of cardiac arrythmias, or treatment of cardiac arrythmias.

[0264] Aspect 52. A device configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient, the device comprising : a vacuum barrier configured to at least partially define a space adjacent the defibrillator electrode pad when the vacuum barrier is coupled to at least one of the defibrillator electrode pad and the patient; a sealing surface associated with the vacuum barrier and configured for coupling the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient and to resist the flow of the fluid into or out from the space when the vacuum barrier is coupled relative to at least one of the defibrillator electrode pad and the patient; and wherein the device is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the sealing surface of the device couples the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the space is at the vacuum. Aspect 53. The device of aspect 52, the sealing surface and the vacuum barrier being separate from the defibrillator electrode pad, the sealing surface being configured to couple the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient before or after the defibrillator electrode pad is applied to the patient.

[0265] Aspect 54. The device of aspect 53, the device being an overlay configured to at least partially cover the defibrillator electrode pad.

[0266] Aspect 55. The device of aspect 54, the overlay being configured to partially cover the defibrillator electrode pad without covering a lead or lead wire connected to the defibrillator electrode pad.

[0267] Aspect 56. The device of aspect 53, the overlay being configured to fully cover the defibrillator electrode pad and create a seal around a lead connected to the defibrillator electrode pad.

[0268] Aspect 57. The device of aspect 52 configured to conform to contours of an anatomy of the patient.

[0269] Aspect 58. A kit comprising the device of aspect 53 and the defibrillator electrode pad.

[0270] Aspect 59. A device configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient, the device comprising : at least one chamber configured to be positioned adjacent the defibrillator electrode pad, the at least one chamber being further configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure; and a coupling surface configured for positioning the at least one chamber relative to at least one of the defibrillator electrode pad and the patient; wherein the device is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the coupling surface of the device positions the at least one chamber relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the at least one chamber is at the pressure.

[0271] Aspect 60. The device of aspect 59, the coupling surface and the at least one chamber being separate from the defibrillator electrode pad, the coupling surface being configured to couple the at least one chamber relative to at least one of the defibrillator electrode pad and the patient before or after the defibrillator electrode pad is applied to the patient. Aspect 61. The device of aspect 60, the at least one chamber and coupling surface being an overlay configured to at least partially cover the defibrillator electrode pad.

[0272] Aspect 62. The device of aspect 61, the overlay being configured to partially cover the defibrillator electrode pad.

[0273] Aspect 63. The device of aspect 59, wherein a decoupling force is required to remove the coupling surface from the patient and a contact force is generated by fluid in the chamber when the fluid in the chamber is at the pressure, and wherein the contact force is less than the decoupling force.

[0274] Aspect 64. The device of aspect 59 configured to conform to contours of an anatomy of the patient.

[0275] Aspect 65. A kit comprising the device of aspect 59 and the defibrillator electrode pad.

[0276] Aspect 66. A method of configuring a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient, the method comprising : positioning a differential pressure barrier adjacent the defibrillator electrode pad to at least partially define a space adjacent the defibrillator electrode pad; and before or after positioning the differential pressure barrier adjacent the defibrillator electrode pad, adhering the defibrillator electrode pad on the patient; forming a chamber to resist the flow of a fluid into or out from the space such that the impedance can be reduced as positive or negative pressure of the fluid in the chamber urges the defibrillator electrode pad toward the patient when the fluid in the chamber is at the positive or negative pressure.

[0277] Aspect 67. The method of aspect 66, further comprising adhering the differential pressure barrier to the patient.

[0278] Aspect 68. The method of aspect 67, wherein forming the chamber includes defining the chamber by the differential pressure barrier and the patient.

[0279] Aspect 69. The method of aspect 66, wherein positioning the differential pressure barrier includes fully covering the defibrillator electrode pad with the differential pressure barrier.

[0280] Aspect 70. The method of aspect 66, wherein positioning the differential pressure barrier includes sealing around a lead connected to the defibrillator electrode pad. Aspect 71. The method of aspect 66, wherein positioning the differential pressure barrier includes partially covering the defibrillator electrode pad with the differential pressure barrier.

[0281] Aspect 72. The method of aspect 71, wherein positioning the differential pressure barrier avoids covering a lead connected to the defibrillator electrode pad.

[0282] Aspect 73. The method of aspect 66, further comprising generating a vacuum in the chamber greater than 0.25 psi gauge and less than full vacuum.

[0283] Aspect 74. The method of aspect 66, further comprising generating a pressure in the chamber to increase the contact force between the defibrillator electrode pad and the patient without exceeding a decoupling force required to remove the differential pressure barrier from the patient.

[0284] Aspect 75. The method of aspect 74, the generating of the pressure in the chamber includes generating greater than 0.25 psi and less than 3 psi.

[0285] Aspect 76. A method of reducing impedance when a defibrillator electrode assembly is applied to a patient, the method comprising : applying the defibrillator electrode assembly to a patient; increasing or decreasing the pressure in a chamber positioned between a differential pressure barrier and a defibrillator electrode of the defibrillator electrode assembly; reducing the impedance as positive or negative pressure in the chamber urges the defibrillator electrode toward the patient when fluid in the chamber is at the positive or negative pressure.

[0286] Aspect 77. The method of aspect 76, further comprising adhering the differential pressure barrier to the patient.

[0287] Aspect 78. The method of aspect 77, further comprising forming the chamber between the differential pressure barrier and the patient.

[0288] Aspect 79. The method of aspect 78, further comprising generating a pressure in the chamber to increase a contact force between the defibrillator electrode and the patient without exceeding a decoupling force required to remove the differential pressure barrier from the patient.

[0289] Aspect 80. The method of aspect 79, the generating of the pressure in the chamber includes generating greater than 0.25 psi.

[0290] Aspect 81. The method of aspect 80, further comprising generating a vacuum in the chamber greater than 0.25 psi and less than full vacuum.

[0291] Aspect 82. A defibrillator system configured to reduce impedance when applied to a patient, the defibrillator system comprising : a defibrillator electrode; a differential pressure barrier coupled to the defibrillator electrode and at least partially defining a space adjacent the defibrillator electrode; a coupling surface associated with the differential pressure barrier and configured for coupling the differential pressure barrier relative to the patient such that the space is contained in a chamber adjacent the defibrillator electrode; and a source of differential pressure associated with the chamber to create positive or negative pressure in the chamber; wherein the defibrillator system is configured to reduce the impedance when the positive or negative pressure is created in the chamber to urge the defibrillator electrode toward the patient when the defibrillator system is applied to the patient.

[0292] Aspect 83. The defibrillator system of aspect 82, further comprising a switch to actuate the source of differential pressure.

[0293] Aspect 84. The defibrillator system of aspect 82, further comprising an impedance sensor for sensing the impedance of the defibrillator system when the defibrillator system is applied to the patient.

[0294] Aspect 85. The defibrillator system of aspect 84, further comprising a visual or audible indicator of impedance of the defibrillator system.

[0295] Aspect 86. The defibrillator system of aspect 85, the indicator being configured to indicate that the system is ready for use for defibrillation.

[0296] Aspect 87. The defibrillator system of aspect 84, further comprising a controller configured to: receive a signal corresponding to the impedance sensed by the impedance sensor; and activate or deactivate the source of differential pressure when a selected impedance is sensed.

[0297] Aspect 88. The defibrillator system of aspect 87, the controller being further configured to monitor the impedance sensed by the impedance sensor continuously, periodically, or responsive to a command.

[0298] Aspect 89. The defibrillator system of aspect 82, further comprising a differential pressure sensor for sensing the positive or negative pressure in the chamber of the defibrillator system when the defibrillator system is applied to the patient.

[0299] Aspect 90. The defibrillator system of aspect 89, further comprising a visual or audible indicator of differential pressure in the chamber. Aspect 91. The defibrillator system of aspect 89, further comprising a controller configured to: receive a signal corresponding to the pressure sensed by the pressure sensor; and activate or deactivate or control the source of differential pressure when a selected pressure is sensed.

[0300] Aspect 92. The defibrillator system of aspect 82, further comprising a controller coupled for communication of signals with the source of differential pressure.

[0301] Aspect 93. The defibrillator system of aspect 92, wherein the communication is wireless.

[0302] Aspect 94. A device configured to be placed over a portion of a defibrillator pad or incorporated into the defibrillator pad that enhances the contact pressure at an electrode-patient contact surface, wherein; a. the device comprises a vacuum containing outer layer and a space which can be evacuated through the application of a vacuum, b. the device is configured to be adhered to the skin of the patient near or around the perimeter of the defibrillator pad, allowing a seal to be created.

[0303] Aspect 95. The device of aspect 94 having a means for generating a vacuum to be pulled on the space which can be evacuated.

[0304] Aspect 96. The device of aspect 94 containing a vacuum distribution media.

[0305] Aspect 97. The device of aspect 94 in which features are provided such that the space that can be evacuated remains open to evacuation and does not seal itself off.

[0306] Aspect 98. The device of aspect 94 in which the pressure applied to the defibrillator electrode assembly is greater than 0.25 psi and less than or equal to 14.7 psi.

[0307] Aspect 99. The device of aspect 97 in which the vacuum is generated by at least one of the following means; a manual pump, an electric pump, a piezoelectric pump, a chemical reaction, a CO2 cartridge, air, hospital room gasses, and / or a venturi vacuum generator.

[0308] Aspect 100. The device of aspect 94 in which heat is also applied to the defibrillator pad to enhance contact between the defibrillator pad and the patient.

[0309] Aspect 101. The device of aspect 100 in which the heat is generated by at least one of a chemical reaction, or electricity. Aspect 102. A device configured to be coupled to a defibrillator pad or incorporated into the defibrillator pad that enhances the contact at the electrodepatient contact surface, wherein; a. a heat source is introduced.

[0310] Aspect 103. The device of aspect 102 in which the heat source improves the conformance of the electrode assembly to the patient's skin.

[0311] Aspect 104. The device of aspect 102 in which the heat source improves the conformance of the electrode gel to the patient's skin.

[0312] Aspect 105. The device of aspect 102 in which the device is coupled to the patient's skin near or surrounding the defibrillator electrode.

[0313] Aspect 106. The device of aspect 102 in which the heat is generated by at least one of a chemical reaction, and / or electricity.

[0314] Aspect 107. The device of aspect 102 in which the contact pressure at the electrode-patient interface is increased.

[0315] Aspect 108. A device configured to be placed over a portion of a defibrillator pad or incorporated into a defibrillator pad that intensifies the contact pressure at the electrode-patient interface, wherein; a. the device comprises a chamber to which a pressure differential can be applied, b. the device is coupled to the skin of the patient near or around the perimeter of the defibrillator pad, allowing a seal to be created.

[0316] Aspect 109. The device of aspect 108 having a means for generating a pressure differential through at least one of pressure and vacuum.

[0317] Aspect 110. The device of aspect 108 containing a gas distribution media.

[0318] Aspect 111. The device of aspect 108 in which features are provided such that gas (such as air) can be removed and spaces (such as chambers and contact surfaces) remain open to evacuation and do not seal off, leaving entrapped gasses.

[0319] Aspect 112. The device of aspect 108 in which features are provided such that the space between the device and the patient and / or defibrillator pad can be evacuated of air.

[0320] Aspect 113. The device of aspect 108 in which the electrode-patient interface pressure applied is greater than 0.25 psi.

[0321] Aspect 114. The device of aspect 113 in which the interface pressure is greater than 0.9 psi and less than 5 psi.

[0322] Aspect 115. The device of aspect 114 in which the interface pressure is greater than 0.9 psi and less than 3 psi. Aspect 116. The device of aspect 111 in which the differential pressure is generated by at least one of the following means; a manual pump, an electric pump, a piezo-electric pump, a chemical reaction, a CO2 cartridge, air, hospital room gasses, and / or a venturi vacuum generator, the mouth of the user.

[0323] Aspect 117. The device of aspect 108 in which heat is also applied, warming the electrolyte.

[0324] Aspect 118. The device of aspect 117 in which the heat is generated by at least one of a chemical reaction, or electricity.

[0325] Aspect 119. The device configured to be placed over a portion of a defibrillator pad or incorporated into a defibrillator pad that intensifies the contact pressure at the electrode-patient interface, wherein; a. the device comprises a vacuum containing chamber which can be evacuated through the application of a vacuum, b. the device is coupled to the skin of the patient by at least one of near, around the perimeter of, within the contact surface of, the defibrillator pad, allowing a seal to be created.

[0326] Aspect 120. The device of aspect 119 having a means for generating a vacuum to be applied to the chamber.

[0327] Aspect 121. The device of aspect 119 containing a gas distribution media.

[0328] Aspect 122. The device of aspect 119 in which features are provided such that the space that can be evacuated remains open to evacuation and does not seal itself off.

[0329] Aspect 123. The device of aspect 119 in which the electrode-patient interface pressure applied is greater than 0.25 psi.

[0330] Aspect 124. The device of aspect 123 in which the interface pressure is greater than 0.9 psi and less than 5 psi.

[0331] Aspect 125. The device of aspect 124 in which the interface pressure is greater than 0.9 psi and less than 3 psi.

[0332] Aspect 126. The device of aspect 122 in which the vacuum is generated by at least one of the following means; a manual pump, an electric pump, a piezo-electric pump, a chemical reaction, a CO2 cartridge, air, hospital room gasses, and / or a venturi vacuum generator.

[0333] Aspect 127. The device of aspect 119 in which heat is applied to enhance contact between the defibrillator pad and the patient. Aspect 128. The device of aspect 127 in which the heat is generated by at least one of a chemical reaction, or electricity.

[0334] Aspect 129. A device configured to be placed over a portion of a defibrillator pad or incorporated into a defibrillator pad that intensifies the contact pressure at the electrode-patient interface, wherein; a. the device comprises a pressure containing chamber which can be pressurized, b. the device is coupled to the skin of the patient by at least one of, near, around the perimeter of, within the contact surface of, the defibrillator pad.

[0335] Aspect 130. The device of aspect 129 having a means for generating pressure.

[0336] Aspect 131. The device of aspect 129 containing a distribution media to allow air to escape.

[0337] Aspect 132. The device of aspect 129 in which the electrode-patient interface pressure applied is greater than 0.25 psi.

[0338] Aspect 133. The device of aspect 132 in which the interface pressure is greater than 0.9 psi and less than 5 psi.

[0339] Aspect 134. The device of aspect 133 in which the interface pressure is greater than 0.9 psi and less than 3 psi.

[0340] Aspect 135. The device of aspect 130 in which the pressure is generated by at least one of the following means; a manual pump, an electric pump, a piezo-electric pump, a chemical reaction, a CO2 cartridge, air, hospital room gasses, and / or a venturi vacuum generator, the mouth of the user.

[0341] Aspect 136. The device of aspect 129 in which heat is also applied to the defibrillator pad to enhance contact between the defibrillator pad and the patient.

[0342] Aspect 137. The device of aspect 136 in which the heat is generated by at least one of a chemical reaction, or electricity.

[0343] Aspect 138. The device configured to be coupled to a defibrillator pad or incorporated into a defibrillator pad that reduces impedance at the electrode-patient interface, wherein; a. a heat source is introduced.

[0344] Aspect 139. The device of aspect 138 in which the contact pressure at the electrode-patient interface is intensified.

[0345] Aspect 140. The device of aspect 138 in which the heat source improves the conformance of the electrode assembly to the patient's skin. Aspect 141. The device of aspect 138 in which the heat source improves the conformance of the electrode gel to the patient's skin.

[0346] Aspect 142. The device of aspect 138 in which the device is coupled to the patient's skin at least one of, near, surrounding the defibrillator electrode, and at the electrode-patient interface.

[0347] Aspect 143. The device of aspect 138 in which the heat is generated by at least one of a chemical reaction, and / or electricity.

[0348] Aspect 144. The device of aspect 138 in which the contact pressure at the electrode-patient interface is increased.

[0349] Aspect 145. The device of at least one of the foregoing aspects, in which the device takes the form of at least one of an overlay, an integrated device.

[0350] Aspect 146. The device of at least one of the foregoing aspects, in which the device is an electrode or used in combination with and electrode for at least one of human diagnosis and human treatment.

[0351] Aspect 147. The device of aspect 52, the device being configured to maintain a vacuum in the space between 0.25 psi gauge and full vacuum.

[0352] Aspect 148. The device of aspect 147, the device being configured to maintain a vacuum in the space greater than 0.25 psi and less than 5 psi.

[0353] Aspect 149. The device of aspect 148, the device being configured to maintain a vacuum in the space greater than 0.25 psi and less than 2 psi.

[0354] Aspect 150. The device of aspect 59, the device being configured to maintain a pressure in the chamber greater than 0.25 psi.

[0355] Aspect 151. The device of aspect 150, the device being configured to maintain a pressure in the chamber greater than 0.25 psi and less than 5 psi.

[0356] Aspect 152. The device of aspect 151, the device being configured to maintain a pressure in the chamber greater than 0.25 psi and less than 2 psi.

[0357] Aspect 153. A method for reducing transthoracic impedance associated with treating or diagnosing a cardiac arrhythmia in a patient, the method comprising : adhering or sealing a defibrillator electrode assembly to the skin of a patient such that a defibrillator electrode of the defibrillator electrode assembly is interposed between the skin of the patient and a differential pressure barrier of the defibrillator electrode assembly; applying a pressure differential to a space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly; urging the defibrillator electrode of the defibrillator electrode assembly into improved contact with the skin of the patient, thereby reducing the transthoracic impedance; and treating or diagnosing the cardiac arrhythmia in the patient after or concurrently with applying the pressure differential to the space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly.

[0358] Aspect 154. The method of aspect 153, wherein adhering or sealing the defibrillator electrode assembly to the skin of the patient includes sealing the differential pressure barrier of the defibrillator electrode assembly to the skin of the patient, thereby enclosing the space between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly.

[0359] Aspect 155. The method of aspect 154, wherein applying the pressure differential to the space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly includes applying a vacuum to the space.

[0360] Aspect 156. The method of aspect 155, wherein applying the vacuum in an amount of 2 psi or less reduces the transthoracic impedance.

[0361] Aspect 157. The method of aspect 155, wherein applying the vacuum in a duration of 30 seconds or less reduces the transthoracic impedance.

[0362] Aspect 158. The method of aspect 153, wherein adhering or sealing the defibrillator electrode assembly to the skin of the patient includes applying the defibrillator electrode of the defibrillator electrode assembly to the skin of the patient and overlaying the differential pressure barrier of the defibrillator electrode assembly over the defibrillator electrode.

[0363] Aspect 159. The method of aspect 153, wherein applying the pressure differential to the space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly includes applying a pressure to a chamber defining the space.

[0364] Aspect 160. The method of aspect 159, wherein adhering or sealing the defibrillator electrode assembly to the skin of the patient includes adhering the defibrillator electrode assembly to the skin of the patient with the chamber adjacent the defibrillator electrode.

[0365] Aspect 161. The method of aspect 160, wherein adhering the defibrillator electrode assembly to the skin of the patient with the chamber adjacent the defibrillator electrode and applying the pressure to the chamber reduces the transthoracic impedance without using a belt, a harness, a strap, a vest, a jacket, or a wrap around the patient.

[0366] Aspect 162. The method of aspect 153, wherein treating or diagnosing the cardiac arrythmia in the patient includes defibrillation.163. The defibrillator electrode assembly of aspect 1, wherein the sealing surface is configured to conform to contours of an anatomy of the patient, such that the sealing surface does not reside within a flat plane when applied to the anatomy of the patient.

[0367] Aspect 164. The defibrillator electrode assembly of aspect 30, wherein the coupling surface is configured to conform to contours of an anatomy of the patient, such that the coupling surface does not reside within a flat plane when applied to the anatomy of the patient.

[0368] Aspect 165. The device of aspect 52, wherein the sealing surface is configured to conform to contours of an anatomy of the patient, such that the sealing surface does not reside within a flat plane when applied to the anatomy of the patient.

[0369] Aspect 166. The device of aspect 59, wherein the coupling surface is configured to conform to contours of an anatomy of the patient, such that the coupling surface does not reside within a flat plane when applied to the anatomy of the patient.

[0370] Aspect 167. The defibrillator system of aspect 82, wherein the coupling surface is configured to conform to contours of an anatomy of the patient, such that the coupling surface does not reside within a flat plane when applied to the anatomy of the patient.

[0371] Aspect 168. The method of aspect 157, wherein applying the vacuum in a duration of 10 seconds or less reduces the transthoracic impedance.

[0372] While preferred embodiments of the invention have been shown and described herein, it will be understood that such embodiments are provided by way of example only. Numerous variations, changes and substitutions will occur to those skilled in the art without departing from the spirit of the invention. Accordingly, it is intended that the appended claims cover all such variations as fall within the spirit and scope of the invention.

Claims

What is Claimed :

1. A defibrillator electrode assembly configured to reduce impedance when the defibrillator electrode assembly is applied to a patient, the defibrillator electrode assembly comprising : a defibrillator electrode; a vacuum barrier coupled to the defibrillator electrode and at least partially defining a space adjacent the defibrillator electrode; and a sealing surface associated with the vacuum barrier and configured for coupling the vacuum barrier relative to the patient such that when the vacuum barrier is coupled relative to the patient, the vacuum barrier is configured to create at least one chamber together with the patient and to resist the flow of fluid into or out from the chamber; wherein the defibrillator electrode assembly is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient.

2. The defibrillator electrode assembly of claim 1 configured to conform to contours of an anatomy of the patient.

3. The defibrillator electrode assembly of claim 1, the sealing surface comprising an adhesive.

4. The defibrillator electrode assembly of claim 2, the adhesive comprising a conductive electrolyte.

5. The defibrillator electrode assembly of claim 2, the adhesive being conductive.

6. The defibrillator electrode assembly of claim 2, the adhesive comprising at least one of a hydrogel and a hydrocolloid.

7. The defibrillator electrode assembly of claim 1, the defibrillator electrode including an electrode adjacent to an electrolyte configured for electrically coupling the electrode to the patient.

8. The defibrillator electrode assembly of claim 1, further comprising a port configured to allow the flow of the fluid into, out from, or into and out from the space.

9. The defibrillator electrode assembly of claim 8, further comprising a valve configured to selectively permit the flow of the fluid into, out from, or into and out from the space such that the space can be brought to or maintained at the vacuum.

10. The defibrillator electrode assembly of claim 9, the valve being a check valve associated with the port.

11. The defibrillator electrode assembly of claim 8, the port being configured for fluid communication with a multi-lumen conduit having parallel axes or coaxial lumens.

12. The defibrillator electrode assembly of claim 9, further comprising a lead wire coupled to the defibrillator electrode, the lead wire being associated with the multi-lumen conduit or within a lumen of the multi-lumen conduit.

13. The defibrillator electrode assembly of claim 1, further comprising a valve configured to relieve the vacuum in the space.

14. The defibrillator electrode assembly of claim 1 having at least one path associated with the space that is configured to remain open to allow fluid in and out from the space.

15. The defibrillator electrode assembly of claim 14, the at least one path being provided by the vacuum barrier having a textured surface.

16. The defibrillator electrode assembly of claim 14, the path being provided by distribution media positioned in the space or on a surface defining the space.

17. The defibrillator electrode assembly of claim 16, the distribution media being selected from the group consisting of an embossed film, a gauze, a screen, channels, a hair-cell texture, beads, open cell foam, pillars, stand-offs, batting, a textured surface, a surface finish, or combinations thereof.

18. The defibrillator electrode assembly of claim 1, the defibrillator electrode assembly being configured to maintain a vacuum in the space between 0.25 psi and full vacuum.

19. The defibrillator electrode assembly of claim 18, the defibrillator electrode assembly being configured to maintain a vacuum in the space greater than 0.25 psi and less than 5 psi.

20. The defibrillator electrode assembly of claim 18, the defibrillator electrode assembly being configured to maintain a vacuum in the space greater than 0.25 psi and less than 2 psi.

21. The defibrillator electrode assembly of claim 1, further comprising a source of differential pressure.

22. The defibrillator electrode assembly of claim 21, the source of differential pressure being selected from the group consisting of a manual or electric or piezo-electric pump, a chemical reaction, a gas cartridge, hospital room fluids, a port for oral pressure or suction, a venturi, and combinations thereof.

23. The defibrillator electrode assembly of claim 1, further comprising a source of heat positioned to transfer heat to the defibrillator electrode assembly.

24. The defibrillator electrode assembly of claim 23, the source of heat being selected from the group consisting of an electrical heater, a warm fluid, or a chemical reaction.

25. The defibrillator electrode assembly of claim 1, the vacuum barrier being configured to be directly coupled to the patient.

26. The defibrillator electrode assembly of claim 25, the sealing surface being configured for directly coupling the vacuum barrier to the patient.

27. The defibrillator electrode assembly of claim 1, the at least one chamber being segmented or baffled.

28. The defibrillator electrode assembly of claim 1 being configured for use for at least one of defibrillation, cardioversion, pacing, electrocardiograms, ECG, the diagnosis of cardiac arrythmias, monitoring of cardiac arrythmias, pacing of cardiac arrythmias, or treatment of cardiac arrythmias.

29. The defibrillator electrode assembly of claim 1, further comprising a differential pressure sensor.

30. A defibrillator electrode assembly configured to reduce impedance when the defibrillator electrode assembly is applied to a patient, the defibrillator electrode assembly comprising : a defibrillator electrode; at least one chamber adjacent the defibrillator electrode, the at least one chamber being configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure; and a coupling surface including an adhesive configured for directly or indirectly coupling the at least one chamber relative to the patient; wherein the defibrillator electrode assembly is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode toward the patient when the defibrillator electrode assembly is applied to the patient and the fluid in the chamber is at the pressure.

31. The defibrillator electrode assembly of claim 30 configured to conform to contours of an anatomy of the patient.

32. The defibrillator electrode assembly of claim 30, wherein the at least one chamber defines a space for receiving the fluid.

33. The defibrillator electrode assembly of claim 32, wherein a decoupling force is required to remove the coupling surface from the patient and a contact force is generated by fluid in the chamber when the fluid in the chamber is at the pressure, and wherein the contact force is less than the decoupling force such thatthe defibrillator electrode assembly does not become decoupled from the patient when the fluid in the chamber is at the pressure.

34. The defibrillator electrode assembly of claim 30, the adhesive configured to couple the at least one chamber to the patient, the adhesive comprising at least one of a pressure sensitive adhesive, a double-sided tape, a biocompatible adhesive, a hydrogel, a hydrocolloid, an acrylic, a conductive adhesive, and an electrolyte adhesive.

35. The defibrillator electrode assembly of claim 30, further comprising an electrolyte adjacent the defibrillator electrode, the electrolyte comprising at least one of a gel, a hydrogel, a hydrocolloid, a paste, and a cream.

36. The defibrillator electrode assembly of claim 30, the electrolyte of claim 35 comprising an adhesive.

37. The defibrillator electrode assembly of claim 30, further comprising a differential pressure sensor.

38. The defibrillator electrode assembly of claim 30, further comprising a port configured to allow the flow of the fluid into, out from, or into and out from the space.

39. The defibrillator electrode assembly of claim 30, further comprising at least one valve configured to selectively permit the flow of the fluid into, out from, or into and out from the space such that the space can be brought to or maintained at the pressure.

40. The defibrillator electrode assembly of claim 39, the at least one valve selected from the group consisting of a check valve, a relief valve, a stopcock, a clamp, a hemostat, and combinations thereof.

41. The defibrillator electrode assembly of claim 38, the port being configured for fluid communication with a multi-lumen conduit having parallel axes or coaxial lumens.

42. The defibrillator electrode assembly of claim 30, further comprising a relief valve configured to allow the flow of the fluid out from the space.

43. The defibrillator electrode assembly of claim 30, the defibrillator electrode assembly being configured to generate a pressure in the chamber greater than 0.25 psi.

44. The defibrillator electrode assembly of claim 30, the defibrillator electrode assembly being configured to maintain a pressure in the chamber greater than 0.25 psi.

45. The defibrillator electrode assembly of claim 44, the defibrillator electrode assembly being configured to maintain a pressure in the chamber greater than 0.25 psi and less than 5 psi.

46. The defibrillator electrode assembly of claim 44, the defibrillator electrode assembly being configured to maintain a pressure in the chamber greater than 0.25 psi and less than 2 psi.

47. The defibrillator electrode assembly of claim 30, further comprising a source of differential pressure.

48. The defibrillator electrode assembly of claim 47, the source of differential pressure being selected from the group consisting of a manual or electric or piezo-electric pump, a chemical reaction, a gas cartridge, hospital room fluids, a port for oral pressure or suction, a venturi, and combinations thereof.

49. The defibrillator electrode assembly of claim 30, the at least one chamber being segmented or baffled.

50. The defibrillator electrode assembly of claim 49, the chambers being configured to flex relative to one another to conform to contours of the anatomy of the patient.

51. The defibrillator electrode assembly of claim 30 being configured for use for at least one of defibrillation, cardioversion, pacing, electrocardiograms, ECG, diagnosis of cardiac arrythmias, monitoring of cardiac arrythmias, pacing of cardiac arrythmias, or treatment of cardiac arrythmias.

52. A device configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient, the device comprising : a vacuum barrier configured to at least partially define a space adjacent the defibrillator electrode pad when the vacuum barrier is coupled to at least one of the defibrillator electrode pad and the patient; a sealing surface associated with the vacuum barrier and configured for coupling the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient and to resist the flow of the fluid into or out from the space when the vacuum barrier is coupled relative to at least one of the defibrillator electrode pad and the patient; and wherein the device is configured to reduce the impedance as a vacuum is created in the space to urge the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the sealing surface of the device couples the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the space is at the vacuum.

53. The device of claim 52, the sealing surface and the vacuum barrier being separate from the defibrillator electrode pad, the sealing surface being configured to couple the vacuum barrier relative to at least one of the defibrillator electrode pad and the patient before or after the defibrillator electrode pad is applied to the patient.

54. The device of claim 53, the device being an overlay configured to at least partially cover the defibrillator electrode pad.

55. The device of claim 54, the overlay being configured to partially cover the defibrillator electrode pad without covering a lead or lead wire connected to the defibrillator electrode pad.

56. The device of claim 53, the overlay being configured to fully cover the defibrillator electrode pad and create a seal around a lead connected to the defibrillator electrode pad.

57. The device of claim 52 configured to conform to contours of an anatomy of the patient.

58. A kit comprising the device of claim 53 and the defibrillator electrode pad.

59. A device configured for use with a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient, the device comprising : at least one chamber configured to be positioned adjacent the defibrillator electrode pad, the at least one chamber being further configured to resist the passage of a fluid and to maintain the fluid in the at least one chamber under pressure; and a coupling surface configured for positioning the at least one chamber relative to at least one of the defibrillator electrode pad and the patient; wherein the device is configured to reduce the impedance as the pressure of the fluid urges the defibrillator electrode pad toward the patient when the defibrillator electrode pad is applied to the patient, the coupling surface of the device positions the at least one chamber relative to at least one of the defibrillator electrode pad and the patient, and the fluid in the at least one chamber is at the pressure.

60. The device of claim 59, the coupling surface and the at least one chamber being separate from the defibrillator electrode pad, the coupling surface being configured to couple the at least one chamber relative to at least one of the defibrillator electrode pad and the patient before or after the defibrillator electrode pad is applied to the patient.

61. The device of claim 60, the at least one chamber and coupling surface being an overlay configured to at least partially cover the defibrillator electrode pad.

62. The device of claim 61, the overlay being configured to partially cover the defibrillator electrode pad.

63. The device of claim 59, wherein a decoupling force is required to remove the coupling surface from the patient and a contact force is generated by fluid in the chamber when the fluid in the chamber is at the pressure, and wherein the contact force is less than the decoupling force.

64. The device of claim 59 configured to conform to contours of an anatomy of the patient.

65. A kit comprising the device of claim 59 and the defibrillator electrode pad.

66. A method of configuring a defibrillator electrode pad to reduce impedance when the defibrillator electrode pad is applied to a patient, the method comprising : positioning a differential pressure barrier adjacent the defibrillator electrode pad to at least partially define a space adjacent the defibrillator electrode pad; and before or after positioning the differential pressure barrier adjacent the defibrillator electrode pad, adhering the defibrillator electrode pad on the patient; forming a chamber to resist the flow of a fluid into or out from the space such that the impedance can be reduced as positive or negative pressure of the fluid in the chamber urges the defibrillator electrode pad toward the patient when the fluid in the chamber is at the positive or negative pressure.

67. The method of claim 66, further comprising adhering the differential pressure barrier to the patient.

68. The method of claim 67, wherein forming the chamber includes defining the chamber by the differential pressure barrier and the patient.

69. The method of claim 66, wherein positioning the differential pressure barrier includes fully covering the defibrillator electrode pad with the differential pressure barrier.

70. The method of claim 66, wherein positioning the differential pressure barrier includes sealing around a lead connected to the defibrillator electrode pad.

71. The method of claim 66, wherein positioning the differential pressure barrier includes partially covering the defibrillator electrode pad with the differential pressure barrier.

72. The method of claim 71, wherein positioning the differential pressure barrier avoids covering a lead connected to the defibrillator electrode pad.

73. The method of claim 66, further comprising generating a vacuum in the chamber greater than 0.25 psi gauge and less than full vacuum.

74. The method of claim 66, further comprising generating a pressure in the chamber to increase the contact force between the defibrillator electrode pad and the patient without exceeding a decoupling force required to remove the differential pressure barrier from the patient.

75. The method of claim 74, the generating of the pressure in the chamber includes generating greater than 0.25 psi and less than 3 psi.

76. A method of reducing impedance when a defibrillator electrode assembly is applied to a patient, the method comprising : applying the defibrillator electrode assembly to a patient; increasing or decreasing the pressure in a chamber positioned between a differential pressure barrier and a defibrillator electrode of the defibrillator electrode assembly; reducing the impedance as positive or negative pressure in the chamber urges the defibrillator electrode toward the patient when fluid in the chamber is at the positive or negative pressure.

77. The method of claim 76, further comprising adhering the differential pressure barrier to the patient.

78. The method of claim 77, further comprising forming the chamber between the differential pressure barrier and the patient.

79. The method of claim 78, further comprising generating a pressure in the chamber to increase a contact force between the defibrillator electrode and the patient without exceeding a decoupling force required to remove the differential pressure barrier from the patient.

80. The method of claim 79, the generating of the pressure in the chamber includes generating greater than 0.25 psi.

81. The method of claim 80, further comprising generating a vacuum in the chamber greater than 0.25 psi and less than full vacuum.

82. A defibrillator system configured to reduce impedance when applied to a patient, the defibrillator system comprising: a defibrillator electrode;a differential pressure barrier coupled to the defibrillator electrode and at least partially defining a space adjacent the defibrillator electrode; a coupling surface associated with the differential pressure barrier and configured for coupling the differential pressure barrier relative to the patient such that the space is contained in a chamber adjacent the defibrillator electrode; and a source of differential pressure associated with the chamber to create positive or negative pressure in the chamber; wherein the defibrillator system is configured to reduce the impedance when the positive or negative pressure is created in the chamber to urge the defibrillator electrode toward the patient when the defibrillator system is applied to the patient.

83. The defibrillator system of claim 82, further comprising a switch to actuate the source of differential pressure.

84. The defibrillator system of claim 82, further comprising an impedance sensor for sensing the impedance of the defibrillator system when the defibrillator system is applied to the patient.

85. The defibrillator system of claim 84, further comprising a visual or audible indicator of impedance of the defibrillator system.

86. The defibrillator system of claim 85, the indicator being configured to indicate that the system is ready for use for defibrillation.

87. The defibrillator system of claim 84, further comprising a controller configured to: receive a signal corresponding to the impedance sensed by the impedance sensor; and activate or deactivate the source of differential pressure when a selected impedance is sensed.

88. The defibrillator system of claim 87, the controller being further configured to monitor the impedance sensed by the impedance sensor continuously, periodically, or responsive to a command.

89. The defibrillator system of claim 82, further comprising a differential pressure sensor for sensing the positive or negative pressure in the chamber of the defibrillator system when the defibrillator system is applied to the patient.

90. The defibrillator system of claim 89, further comprising a visual or audible indicator of differential pressure in the chamber.

91. The defibrillator system of claim 89, further comprising a controller configured to:receive a signal corresponding to the pressure sensed by the pressure sensor; and activate or deactivate or control the source of differential pressure when a selected pressure is sensed.

92. The defibrillator system of claim 82, further comprising a controller coupled for communication of signals with the source of differential pressure.

93. The defibrillator system of claim 92, wherein the communication is wireless.

94. A device configured to be placed over a portion of a defibrillator pad or incorporated into the defibrillator pad that enhances the contact pressure at an electrode-patient contact surface, wherein; a. the device comprises a vacuum containing outer layer and a space which can be evacuated through the application of a vacuum, b. the device is configured to be adhered to the skin of the patient near or around the perimeter of the defibrillator pad, allowing a seal to be created.

95. The device of claim 94 having a means for generating a vacuum to be pulled on the space which can be evacuated.

96. The device of claim 94 containing a vacuum distribution media.

97. The device of claim 94 in which features are provided such that the space that can be evacuated remains open to evacuation and does not seal itself off.

98. The device of claim 94 in which the pressure applied to the defibrillator electrode assembly is greater than 0.25 psi and less than or equal to 14.7 psi.

99. The device of claim 97 in which the vacuum is generated by at least one of the following means; a manual pump, an electric pump, a piezo-electric pump, a chemical reaction, a CO2 cartridge, air, hospital room gasses, and / or a venturi vacuum generator.

100. The device of claim 94 in which heat is also applied to the defibrillator pad to enhance contact between the defibrillator pad and the patient.

101. The device of claim 100 in which the heat is generated by at least one of a chemical reaction, or electricity.

102. A device configured to be coupled to a defibrillator pad or incorporated into the defibrillator pad that enhances the contact at the electrodepatient contact surface, wherein; a. a heat source is introduced.

103. The device of claim 102 in which the heat source improves the conformance of the electrode assembly to the patient's skin.

104. The device of claim 102 in which the heat source improves the conformance of the electrode gel to the patient's skin.

105. The device of claim 102 in which the device is coupled to the patient's skin near or surrounding the defibrillator electrode.

106. The device of claim 102 in which the heat is generated by at least one of a chemical reaction, and / or electricity.

107. The device of claim 102 in which the contact pressure at the electrode-patient interface is increased.

108. A device configured to be placed over a portion of a defibrillator pad or incorporated into a defibrillator pad that intensifies the contact pressure at the electrode-patient interface, wherein; a. the device comprises a chamber to which a pressure differential can be applied, b. the device is coupled to the skin of the patient near or around the perimeter of the defibrillator pad, allowing a seal to be created.

109. The device of claim 108 having a means for generating a pressure differential through at least one of pressure and vacuum.

110. The device of claim 108 containing a gas distribution media.

111. The device of claim 108 in which features are provided such that gas (such as air) can be removed and spaces (such as chambers and contact surfaces) remain open to evacuation and do not seal off, leaving entrapped gasses.

112. The device of claim 108 in which features are provided such that the space between the device and the patient and / or defibrillator pad can be evacuated of air.

113. The device of claim 108 in which the electrode-patient interface pressure applied is greater than 0.25 psi.

114. The device of claim 113 in which the interface pressure is greater than 0.9 psi and less than 5 psi.

115. The device of claim 114 in which the interface pressure is greater than 0.9 psi and less than 3 psi.

116. The device of claim 111 in which the differential pressure is generated by at least one of the following means; a manual pump, an electric pump, a piezo-electric pump, a chemical reaction, a CO2 cartridge, air, hospital room gasses, and / or a venturi vacuum generator, the mouth of the user.

117. The device of claim 108 in which heat is also applied, warming the electrolyte.

118. The device of claim 117 in which the heat is generated by at least one of a chemical reaction, or electricity.

119. The device configured to be placed over a portion of a defibrillator pad or incorporated into a defibrillator pad that intensifies the contact pressure at the electrode-patient interface, wherein; a. the device comprises a vacuum containing chamber which can be evacuated through the application of a vacuum, b. the device is coupled to the skin of the patient by at least one of near, around the perimeter of, within the contact surface of, the defibrillator pad, allowing a seal to be created.

120. The device of claim 119 having a means for generating a vacuum to be applied to the chamber.

121. The device of claim 119 containing a gas distribution media.

122. The device of claim 119 in which features are provided such that the space that can be evacuated remains open to evacuation and does not seal itself off.

123. The device of claim 119 in which the electrode-patient interface pressure applied is greater than 0.25 psi.

124. The device of claim 123 in which the interface pressure is greater than 0.9 psi and less than 5 psi.

125. The device of claim 124 in which the interface pressure is greater than 0.9 psi and less than 3 psi.

126. The device of claim 122 in which the vacuum is generated by at least one of the following means; a manual pump, an electric pump, a piezo-electric pump, a chemical reaction, a CO2 cartridge, air, hospital room gasses, and / or a venturi vacuum generator.

127. The device of claim 119 in which heat is applied to enhance contact between the defibrillator pad and the patient.

128. The device of claim 127 in which the heat is generated by at least one of a chemical reaction, or electricity.

129. A device configured to be placed over a portion of a defibrillator pad or incorporated into a defibrillator pad that intensifies the contact pressure at the electrode-patient interface, wherein;a. the device comprises a pressure containing chamber which can be pressurized, b. the device is coupled to the skin of the patient by at least one of, near, around the perimeter of, within the contact surface of, the defibrillator pad.

130. The device of claim 129 having a means for generating pressure.

131. The device of claim 129 containing a distribution media to allow air to escape.

132. The device of claim 129 in which the electrode-patient interface pressure applied is greater than 0.25 psi.

133. The device of claim 132 in which the interface pressure is greater than 0.9 psi and less than 5 psi.

134. The device of claim 133 in which the interface pressure is greater than 0.9 psi and less than 3 psi.

135. The device of claim 130 in which the pressure is generated by at least one of the following means; a manual pump, an electric pump, a piezo-electric pump, a chemical reaction, a CO2 cartridge, air, hospital room gasses, and / or a venturi vacuum generator, the mouth of the user.

136. The device of claim 129 in which heat is also applied to the defibrillator pad to enhance contact between the defibrillator pad and the patient.

137. The device of claim 136 in which the heat is generated by at least one of a chemical reaction, or electricity.

138. The device configured to be coupled to a defibrillator pad or incorporated into a defibrillator pad that reduces impedance at the electrode-patient interface, wherein; a. a heat source is introduced.

139. The device of claim 138 in which the contact pressure at the electrode-patient interface is intensified.

140. The device of claim 138 in which the heat source improves the conformance of the electrode assembly to the patient's skin.

141. The device of claim 138 in which the heat source improves the conformance of the electrode gel to the patient's skin.

142. The device of claim 138 in which the device is coupled to the patient's skin at least one of, near, surrounding the defibrillator electrode, and at the electrode-patient interface.

143. The device of claim 138 in which the heat is generated by at least one of a chemical reaction, and / or electricity.

144. The device of claim 138 in which the contact pressure at the electrode-patient interface is increased.

145. The device of at least one of the foregoing claims, in which the device takes the form of at least one of an overlay, an integrated device.

146. The device of at least one of the foregoing claims, in which the device is an electrode or used in combination with and electrode for at least one of human diagnosis and human treatment.

147. The device of claim 52, the device being configured to maintain a vacuum in the space between 0.25 psi gauge and full vacuum.

148. The device of claim 147, the device being configured to maintain a vacuum in the space greater than 0.25 psi and less than 5 psi.

149. The device of claim 148, the device being configured to maintain a vacuum in the space greater than 0.25 psi and less than 2 psi.

150. The device of claim 59, the device being configured to maintain a pressure in the chamber greater than 0.25 psi.

151. The device of claim 150, the device being configured to maintain a pressure in the chamber greater than 0.25 psi and less than 5 psi.

152. The device of claim 151, the device being configured to maintain a pressure in the chamber greater than 0.25 psi and less than 2 psi.

153. A method for reducing transthoracic impedance associated with treating or diagnosing a cardiac arrhythmia in a patient, the method comprising: adhering or sealing a defibrillator electrode assembly to the skin of a patient such that a defibrillator electrode of the defibrillator electrode assembly is interposed between the skin of the patient and a differential pressure barrier of the defibrillator electrode assembly; applying a pressure differential to a space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly; urging the defibrillator electrode of the defibrillator electrode assembly into improved contact with the skin of the patient, thereby reducing the transthoracic impedance; and treating or diagnosing the cardiac arrhythmia in the patient after or concurrently with applying the pressure differential to the space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly.

154. The method of claim 153, wherein adhering or sealing the defibrillator electrode assembly to the skin of the patient includes sealing thedifferential pressure barrier of the defibrillator electrode assembly to the skin of the patient, thereby enclosing the space between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly.

155. The method of claim 154, wherein applying the pressure differential to the space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly includes applying a vacuum to the space.

156. The method of claim 155, wherein applying the vacuum in an amount of 2 psi or less reduces the transthoracic impedance.

157. The method of claim 155, wherein applying the vacuum in a duration of 30 seconds or less reduces the transthoracic impedance.

158. The method of claim 153, wherein adhering or sealing the defibrillator electrode assembly to the skin of the patient includes applying the defibrillator electrode of the defibrillator electrode assembly to the skin of the patient and overlaying the differential pressure barrier of the defibrillator electrode assembly over the defibrillator electrode.

159. The method of claim 153, wherein applying the pressure differential to the space defined between the defibrillator electrode of the defibrillator electrode assembly and the pressure differential barrier of the defibrillator electrode assembly includes applying a pressure to a chamber defining the space.

160. The method of claim 159, wherein adhering or sealing the defibrillator electrode assembly to the skin of the patient includes adhering the defibrillator electrode assembly to the skin of the patient with the chamber adjacent the defibrillator electrode.

161. The method of claim 160, wherein adhering the defibrillator electrode assembly to the skin of the patient with the chamber adjacent the defibrillator electrode and applying the pressure to the chamber reduces the transthoracic impedance without using a belt, a harness, a strap, a vest, a jacket, or a wrap around the patient.

162. The method of claim 153, wherein treating or diagnosing the cardiac arrythmia in the patient includes defibrillation.

163. The defibrillator electrode assembly of claim 1, wherein the sealing surface is configured to conform to contours of an anatomy of the patient, such that the sealing surface does not reside within a flat plane when applied to the anatomy of the patient.

164. The defibrillator electrode assembly of claim 30, wherein the coupling surface is configured to conform to contours of an anatomy of the patient,such that the coupling surface does not reside within a flat plane when applied to the anatomy of the patient.

165. The device of claim 52, wherein the sealing surface is configured to conform to contours of an anatomy of the patient, such that the sealing surface does not reside within a flat plane when applied to the anatomy of the patient.

166. The device of claim 59, wherein the coupling surface is configured to conform to contours of an anatomy of the patient, such that the coupling surface does not reside within a flat plane when applied to the anatomy of the patient.

167. The defibrillator system of claim 82, wherein the coupling surface is configured to conform to contours of an anatomy of the patient, such that the coupling surface does not reside within a flat plane when applied to the anatomy of the patient.

168. The method of claim 157, wherein applying the vacuum in a duration of 10 seconds or less reduces the transthoracic impedance.

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