Abstract: The present invention is directed to a physiological recording device and, more particularly, to a physiological recording device that can be used without skin preparation or the use of electrolytic gels. The invention is further directed to an encouragement ring which stabilizes and helps situate the physiological recording device on a subject's skin to help provide a better electrical signal, increase surface area, and reduce and minimize noise and artifacts during the process of recording or monitoring a physiological signal. The invention is still further directed to surface features on a surface of the physiological recording device with a size and shape that will not substantially bend or break, which limits the depth of application of the recording device, and/or anchors the recording device during normal application. The invention is even further directed to a method for manufacturing a physiological recording device, and minimizing cost of manufacture.

Abstract: An electroencephalogram electrode includes: a bottom portion on which a connection member is placed, the connection member which is configured to supply a biological signal that is acquired from a subject through conductive gel, to an external apparatus; an annular wall which annularly extends from the bottom portion in a contact direction with respect to the subject; and a plurality of barb members which are disposed in a holding space for the conductive gel that is located inside the annular wall, and which elongate from the bottom portion in the contact direction with respect to the subject.

Abstract: An electrode interface system for providing a connection between at least one electrode and a maternal-fetal monitor, wherein the interface system converts electrical muscle activity captured by the electrode(s) into uterine activity data signals for use by the maternal-fetal monitor. The electrode interface system of the invention preferably includes a conversion means for converting the signals from the electrode(s) into signals similar to those produced by a tocodynometer.

Abstract: A surgical device integrating a suction mechanism with a coagulation mechanism is provided for improving lesion creation capabilities. The device comprises an elongate member having an insulative covering attached about means for coagulating soft tissue. Openings through the covering expose regions of the coagulation-causing elements and are coupled to lumens in the elongate member which are routed to a vacuum source. A fluid source to passively transport fluid along the contacted soft tissue surface may be provided in order to push the maximum temperature deeper into tissue.

Abstract: Devices and methods provide for ablation of cardiac tissue for treating cardiac arrhythmias such as atrial fibrillation. Although the devices and methods are often be used to ablate epicardial tissue in the vicinity of at least one pulmonary vein, various embodiments may be used to ablate other cardiac tissues in other locations on a heart. Devices generally include at least one tissue contacting member for contacting epicardial tissue and securing the ablation device to the epicardial tissue, and at least one ablation member for ablating the tissue. Various embodiments include features, such as suction apertures, which enable the device to attach to the epicardial surface with sufficient strength to allow the tissue to be stabilized via the device. For example, some embodiments may be used to stabilize a beating heart to enable a beating heart ablation procedure. Many of the devices may be introduced into a patient via minimally invasive introducer devices and the like.

Abstract: The described embodiments relate to a self-regulating patch for taking biopotential measurements and balancing accurate measurements and user comfort. The self-regulating patch including: a heating element operable to generate heat that causes formation of sweat at the skin surface; a biopotential sensor; an exterior surface constructed of a moisture wicking material enveloping the heating element; and a logic to concurrently activate the biopotential sensor and transition the self-regulating patch between a plurality of modes, including a comfort mode and an accuracy mode, where in the comfort mode the heating element is inactive and in the accuracy mode the heating element is active.

Abstract: A Carbon NanoTube (CNT) composite electrode includes a lower electrode having a through-hole formed therein, and configured to be attached to the skin of a subject body to detect a biosignal, an upper electrode provided on one surface of the lower electrode to form an enclosed space between the lower electrode and the upper electrode, and configured to receive the biosignal detected by the lower electrode, and an air discharge portion formed in at least one of the lower electrode and the upper electrode, and discharging air present in the enclosed space and the through-hole externally so as to be configured to allow the upper electrode and the lower electrode to be attached to the skin of the subject body via vacuum suction.

Abstract: The present invention is directed to a physiological recording device, or other types of sensors to detect a biopotential, and more particularly, a physiological recording electrode that can be used without skin preparation or the use of electrolytic gels. The invention is further directed to the configurations of structures on the physiological recording electrode's lower surface. The structures having a length, width, and height, which are capable, at least in part, of transmitting an electric potential from the skin which can be measured. The structures may or may not limit the depth of application, and/or anchor the electrode or other device during normal application, and/or allow for uniform application of the electrode or other device over unprepared skin.

Abstract: The present invention is directed to a physiological recording device and, more particularly, to a physiological recording device that can be used without skin preparation or the use of electrolytic gels. The invention is further directed to an encouragement ring which stabilizes and helps situate the physiological recording device on a subject's skin to help provide a better electrical signal, increase surface area, and reduce and minimize noise and artifacts during the process of recording or monitoring a physiological signal. The invention is still further directed to surface features on a surface of the physiological recording device with a size and shape that will not substantially bend or break, which limits the depth of application of the recording device, and/or anchors the recording device during normal application. The invention is even further directed to a method for manufacturing a physiological recording device, and minimizing cost of manufacture.

Abstract: An apparatus and methods for performing ablation of myocardial tissues are disclosed. The apparatus includes a plurality of ablation electrode configurations to which nanosecond pulsed electric fields are applied. The methods relate to therapies to treat cardiac arrhythmias, such as, atrial fibrillation and scar-related ventricular tachycardia, amongst others. The affected myocardial tissues are ablated creating a plurality of lesions enabled by the nanosecond pulsed electric fields applied to either penetrating electrodes, endo-endo electrodes, or endo-epi electrodes. Different electrophysiological tests are performed to assess the application of nanosecond pulsed electric field ablation to specific desired tissue location within the heart. Test results show the potential to overcome limitations of current ablation therapies, thereby providing patients and doctors a superior treatment for cardiac arrhythmias.

Abstract: The present invention is directed to a physiological recording device, or other types of sensors to detect a biopotential, and more particularly, a physiological recording electrode that can be used without skin preparation or the use of electrolytic gels. The invention is further directed to the configurations of structures on the physiological recording electrode's lower surface. The structures having a length, width, and height, which are capable, at least in part, of transmitting an electric potential from the skin which can be measured. The structures may or may not limit the depth of application, and/or anchor the electrode or other device during normal application, and/or allow for uniform application of the electrode or other device over unprepared skin.

Abstract: Example headsets and electrodes are described herein. Example electrode units described herein include a guide defining an opening and an electrode disposed in the opening. The electrode has a housing, a spring, and a pin. The pin is biased outward from a first end of the housing via the first spring. The example electrode units also include a second spring disposed over the opening adjacent a second end of the housing.

Abstract: The present invention is directed to a physiological recording device and, more particularly, to a physiological recording device that can be used without skin preparation or the use of electrolytic gels. The invention is further directed to an encouragement ring which stabilizes and helps situate the physiological recording device on a subject's skin to help provide a better electrical signal, increase surface area, and reduce and minimize noise and artifacts during the process of recording or monitoring a physiological signal. The invention is still further directed to surface features on a surface of the physiological recording device with a size and shape that will not substantially bend or break, which limits the depth of application of the recording device, and/or anchors the recording device during normal application. The invention is even further directed to a method for manufacturing a physiological recording device, and minimizing cost of manufacture.

Abstract: Described herein are methods and devices for selectively applying either fluids (e.g., anesthetics, nerve-blockers, etc.) or energy, such as radiofrequency or ultrasound energy, to a target tissue from within a blood vessel while minimizing the amount of fluid or energy applied to non-target tissue. The catheters described herein may include an elongate body, a directional injector, and one or more holdfasts for securing the catheter. In addition, catheters can include energy applying features for delivering energy to the target tissue.

Abstract: Surgical systems and methods for administering an ablation treatment and other therapeutic or diagnostic protocols to a patient tissue involve a flexible stabilizer mechanism having an inner recess and an ablation mechanism coupled with the stabilizer mechanism.

Abstract: Medical devices are described for performing mapping, ablating, and/or pacing procedures on one or more layers of the cardiac wall via an epicardial approach in a minimally invasive (e.g., orthoscopic) surgical procedure. One of the medical devices described includes a main support member and one or more secondary support members extending outwardly from the main support member having electrodes configured to receive electrical impulses. The secondary support member may include a support pad configured to be removably attached to a corresponding area of the epicardium for holding the medical device in place during a procedure, such as through application of vacuum pressure via a containment dome provided on each secondary support member. Further, an ablating electrode may be slidably disposed along the main support member for transmitting energy to a target site proximate the electrode. Associated methods are also described.

Abstract: The present invention is directed to a physiological recording device, or other types of sensors to detect a biopotential, and more particularly, a physiological recording electrode that can be used without skin preparation or the use of electrolytic gels. The invention is further directed to the configurations of structures on the physiological recording electrode's lower surface. The structures having a length, width, and height, which are capable, at least in part, of transmitting an electric potential from the skin which can be measured. The structures may or may not limit the depth of application, and/or anchor the electrode or other device during normal application, and/or allow for uniform application of the electrode or other device over unprepared skin.

Abstract: An electrode assembly for electrical impedance tomography comprising a plurality of different electrode modules, each containing a support strap made of a flexible material that presents a reduced longitudinal deformability and carrying a predetermined number of electrodes, each support strap being dimensioned to be seated and retained onto a respective extension portion of a body segment of a patient. Each electrode module presents the number of electrodes and a distance “De” between each two consecutive electrodes predetermined as a function of a specific operational pattern to be obtained from each electrode module. The assembly can further comprise an electrical conducting cable having an end connected to a monitoring apparatus and a free end provided with a connector to be coupled to a respective electrode of an electrode module.

Abstract: A sensor instrument for generation of electrocardiograms, in particular for cardiac computed tomography, has two electrodes, an electronic module and a support, wherein multiple suction elements for affixing the support to the body of a subject (are positioned on the support.

Abstract: The present invention relates to a wearable device (10) wearable by a user for measuring skin conductance of the user (1), the wearable device comprising at least two skin conductance electrodes (12) for contacting skin (2) of the user, and an elastic material portion (14) which surrounds the skin conductance electrodes (12) and forms a material surface (16). The elastic material of the elastic material portion (14) is non-permeable for gaseous and liquid substances. The present invention further relates to a method of manufacturing such a wearable device (10).

Abstract: The present invention is directed to systems, apparatus, methods and procedures for the noninvasive treatment of tissue using microwave energy. In one embodiment of the invention a medical device and associated apparatus and procedures are used to treat dermatological conditions using microwave energy.

Abstract: A medical electrical lead electrode assembly includes an insulative carrier and at least one conductive component. The at least one conductive component includes an electrode portion disposed on a first side of the carrier and at least one tab extending away from the electrode portion, through the carrier to a second side of the carrier. The electrode portion of the at least one component includes an outward facing contact surface and an inward facing surface, the inward facing surface being disposed opposite the contact surface and against a surface of the first side of the carrier. The electrode assembly further includes a joint coupling a flexible elongate conductor to the tab of the at least one component on the second side of the carrier, and an insulative layer extending over the joint and the tab and the conductor, the insulative layer being bonded to the second side of the carrier.

Abstract: Disclosed herein is a mountable unit for biological signal measurement, including: three electrodes; and a support body configured to support the three electrodes at positions corresponding to a positional relationship among a predetermined position on a forehead on one side of a face bounded by a midline, a temple position on the one side of the face, and a predetermined position on a zygomatic body on the one side of the face.

Abstract: An apparatus (10) adapted to contact epithelial tissue, the apparatus comprising a cup (12) having a concave shape and adapted to be positioned on epithelial tissue, the cup capable of maintaining a reduced air pressure and holding a volume of flowable material; and an electrical support structure (14) comprising a support structure and a plurality of sensors, electrodes, or both (15) configured to interact with epithelial and subepithelial tissue.

Abstract: A pressure sensor is deployed in the right atrium and is in contact with the tissue of the fossa ovalis. The fossa ovalis acts as a membrane and the pressure sensor determines the relative and/or absolute pressure within the left atrium while remaining within the right atrium. A variety of embodiment are provided to deploy and anchor the sensor into the proper position.

Abstract: A pressure sensor is deployed in the right atrium and is in contact with the tissue of the fossa ovalis. The fossa ovalis acts as a membrane and the pressure sensor determines the relative and/or absolute pressure within the left atrium while remaining within the right atrium. A variety of embodiment are provided to deploy and anchor the sensor into the proper position.

Abstract: A pressure sensor is deployed in the right atrium and is in contact with the tissue of the fossa ovalis. The fossa ovalis acts as a membrane and the pressure sensor determines the relative and/or absolute pressure within the left atrium while remaining within the right atrium. A variety of embodiment are provided to deploy and anchor the sensor into the proper position.

Abstract: The method described herein relates to using electrical and/or chemical stimulation to treat depression or anxiety related disorders, such as obsessive compulsive disorder. More specifically, the inferior thalamic peduncle or reticular thalamic nucleus is stimulated to treat depression or anxiety related disorders.

Abstract: In general, invention is directed to devices for use in surgical procedures in which a medical implant is affixed to or implanted within an exterior surface of a body organ. A system, for example, is described that includes a cannula and a delivery instrument disposed within the cannula to fix a medical implant to an exterior surface of an organ. The delivery instrument has a distal end including a cavity and a vacuum port to draw a portion of the exterior surface of the organ into the cavity. The medical implant is affixed to the portion of the exterior surface drawn into the cavity of the delivery instrument.

Abstract: An apparatus and method for detecting physiological function, for example, nerve conduction, is described. In one embodiment the apparatus includes a housing including a stimulator shaped to fit a first anatomical site and a detector shaped to fit a second anatomical site. The housing automatically positions the detector substantially adjacent to the second anatomical site when the stimulator is positioned substantially adjacent to the first anatomical site. The detector contains a plurality of individual detection elements, whereby the response evoked by stimulation at the first anatomical site is measured using one or more of these detection elements at the second anatomical location.

Abstract: The present invention provides for an ECG electrode system that includes the use of electrodes adapted to attach to the body via suction. The invention includes a lightweight and compact air pump in combination with air connection hoses, a lightweight air distribution unit, associated electrode tubes, and respective electrodes adapted to be positioned by the Venturi principle, and corresponding electrical leads and recorders/monitors. The electrode leads can each be positioned within respective air connections hoses, e.g., in a manner that is concentric or coaxial with the axis of the connection hoses, in order to both protect the leads themselves and facilitate their positioning.

Abstract: A tissue interface device (10) suitable for positioning on or about one or more artificial openings in a biological membrane of an organism and for coupling to a monitor and control unit and a vacuum source. The tissue interface device (10) comprises a housing (100), a sensor channel (130), and a sensor (150). The housing (100) defines an orifice (120), the orifice (120) having an open inlet port (122) on the bottom end (102) of the housing (100) and a distal end (124) that is in fluid communication with the sensor channel (130). The orifice (120) is in fluid communication with fluid that flows from the artificial opening formed in the biological membranes. The sensor channel (130) is for coupling to, and fluid communication therewith, the vacuum source. The sensor (150) is positioned in the sensor channel (130) in a flow path of the fluid for sensing a characteristic of the fluid as it flows out from the artificial opening. The sensor generates a sensor signal representative thereof.

Abstract: A suction assisted ablation device having a support surface, suction elements disposed adjacent the support surface, at least one electrode and at least one suction conduit is provided. The device may further include fluid openings, which allow fluid to irrigate target tissue and aid in ablation. A method for ablating tissue using suction is also provided.

Abstract: A non-invasive medical probe includes a suction cup adapted to be secured by vacuum to a patient's skin and supporting an electrode, a source of vacuum, and a resilient walled tube structure connecting the source of vacuum to the suction cup, the source of vacuum including a resilient bellows operative when fully compressed and then released to apply a predetermined low level of vacuum to the suction cup and an arrangement connected with the bellows for enabling the bellows to be further extended manually in order to increase the vacuum applied to the suction cup to a higher level, the arrangement including a thumb ring secured to a closed end of the bellows and a finger abutment at an opposite end of the bellows.

Abstract: A contactor for establishing electrical Communication with organic tissue, the contactor including a cup-shaped housing of one-piece rubbery material including a closing end-wall connected across an annular sidewall with rice defining an open mouth into a main recess. An electrode in the recess corgi a contact plate with first side facing the mouth to contact organic tissue, and a second side with a pair of leg-like extensions and a center limiter post ail of one-piece molded plastics coated with a thin layer of conductor preferably silver/silver chloride to be electrically conductive on the exterior surface of the electrode. The legs of the electrode snap fit against to physically and electrically connect with an electrically conductive venturi tube mounted extending through the housing, the venturi tube having a suction port positioned such that when high pressure gas is passed through the venturi tube, a vacuum is created within the housing recess.

Abstract: A securing apparatus for selectively securing an ablating element of an ablation instrument proximate to a targeted region of a biological tissue. The securing apparatus includes a support base affixed to the ablation instrument relative the ablating element, and having a support face adapted to seat against the biological tissue proximate to the ablation element. The support base further defines a passage having one end communicably coupled to a vacuum source and an opposite end terminating at an orifice at the support face. The support face together with the biological tissue forms a hermetic seal thereagainst during operation of the vacuum source to secure the ablation instrument thereagainst. Essentially, the hermetic seal and the vacuum source cooperate to form a vacuum force sufficient to retain the ablation device against the biological tissue.

Abstract: An electrolyte (70) for use in a single-use biomedical electrode assembly (A, B, C, D) designed for receiving body-generated electrical signals at a patient's skin surface includes: Component Range (%) Skin penetration agent 10-25  Thickener 0-10 Alkali metal or alkaline earth 1-13 metal chloride Alkali metal or alkali earth 1-13 metal nitrate Surfactant 0.001-5    Soluble silver salt, as silver   0-0.01 Buffer 0-10 Water Q.S. The skin penetration agent improves penetration of the outer, dead skin layers by the electrolyte, thereby improving pickup of minute electrical signals generated within the patient's body. A preferred skin penetration agent includes sodium 2-pyrrolidone-5 carboxylate at a concentration of 15-20% by weight of the electrolyte composition.

Abstract: A contactor for establishing electrical communication with organic tissue, the contactor including a cup-shaped housing of one-piece rubbery material including a closing end-wall connected across an annular sidewall with rim defining an open mouth into a main recess. An electrode in the recess comprises a contact plate with first side facing the mouth to contact organic tissue, and a second side with a pair of leg-like extensions and a center limiter post all of one-piece molded plastics coated with a thin layer of conductor preferably silver/silver chloride to be electrically conductive on the exterior surface of the electrode. The legs of the electrode snap fit against to physically and electrically connect with an electrically conductive venturi tube mounted extending through the housing, the venturi tube having a suction port positioned such that when high pressure gas is passed through the venturi tube, a vacuum is created within the housing recess.

Abstract: A non-invasive medical probe includes a suction cup adapted to be secured by vacuum to a patient's skin and supporting an electrode, a source of vacuum, and a resilient walled tube structure connecting the source of vacuum to the suction cup, the source of vacuum including a resilient bellows operative when fully compressed and then released to apply a predetermined low level of vacuum to the suction cup and an arrangement connected with the bellows for enabling the bellows to be further extended manually in order to increase the vacuum applied to the suction cup to a higher level, the arrangement including a thumb ring secured to a closed end of the bellows and a finger abutment at an opposite end of the bellows.

Abstract: Vacuum in a non-invasive medical probe having a source of vacuum interconnected with a suction cup by a resilient walled tube, is reduced in a controlled manner by creating a valve aperture in the wall of the tube at a desired location through which aperture no appreciable leakage will occur when vacuum is applied and the tube is in a relaxed state, whereby with the suction cup secured by vacuum on a patient's skin, application of a force to the tube wall will open the aperture and permit a controlled reduction of vacuum in the suction cup to a specified amount. Releasing the force permits the aperture to close so that lower vacuum is maintained and the suction cup continues to be secured on the patient's skin. In a preferred application there is provided a probe adapted for application to the scalp of a fetus with the rim of the suction cup in sealing contact with the surface of the scalp.

Abstract: The invention relates to an electrode device (20), which for the purpose of obviating problems that have existed so far is applicable to the skin in an airtight manner for raising, by means of negative pressure and preferably heat, a portion of the epidermis and causing interstitial fluid and/or the epidermal basement membrane to contact an electrode for a measuring operation.

Abstract: A self contained, compact, long term, ambulatory physiological recorder is designed for mounting directly to the body of a patient, immediately adjacent to the organ or system that is to be monitored, and is adhesively and covertly held there in place and comfortably under clothing by the very transducer, skin electrodes that detect the physiological information to be recorded, and thereby increasing continuity and decreasing artifact by obviating the need for numerous and cumbersome, hanging electrode leads as well as unsightly and cumbersome recorder pouches suspended from shoulder straps or belts.

Abstract: A biomedical electrode for an electrocardiograph or similar device is provided. The biomedical electrode includes a disposable electrode having an electrically conductive gel layer and a smooth layer film. The disposable electrode interfaces with a reusable leadwire connector having the relatively expensive metallic conductive material. The reusable leadwire adapter includes a vinyl top layer which attaches to the smooth layer film of the disposable electrode through surface attraction. The reusable leadwire adapter may include a suction cup which attaches to the disposable electrode through a partial vacuum. The reusable leadwire also includes a stud member which snaps into a standard leadwire connector.

Abstract: A biomedical electrode for an electrocardiograph or similar device is provided. The biomedical electrode includes a disposable electrode having an electrically conductive gel layer and a smooth layer film. The disposable electrode interfaces with a reusable leadwire connector having the relatively expensive metallic conductive material. The reusable leadwire adapter includes a vinyl top layer which attaches to the smooth layer film of the disposable electrode through surface attraction. The reusable leadwire adapter may include a suction cup which attaches to the disposable electrode through a partial vacuum. The reusable leadwire also includes a stud member which snaps into a standard leadwire connector.

Abstract: An electrode patch used in tests of physical health conditions such as an electrocardiograph (ECG) electrode patch having marking means which leaves a position mark in the test site on a person being tested to permit accurate location of the site for accurate placement of electrode patches in subsequent tests in a series of test procedures on the site.

Abstract: Biomedical measurements such as ECG or EEG measurements are frequently performed using a suction electrode. An electrolyte is applied to the skin of the patient and a suction electrode is placed thereon to form an electrically conducting connection between the skin and the electrode. In accordance with the present invention and hygienic improvement is provided by introducing an interface element between the skin of the patient and the reusable electrode. The interface element is preferably provided in the form of a lamellar substrate for an electrolyte having a skin contact surface and an opposed electrode contact surface. The substrate further includes a central portion, a peripheral margin portion and an intermediate portion disposed between the central portion and the peripheral margin portion. The peripheral margin portion is adapted to form a vacuum seal against the skin of the patient with a seal portion of an applied biomedical electrode.

Abstract: A reusable electrode holder and associated disposable electrode unit are provided. The holder retains the electrode therein and is connectable to a vacuum source for holding the electrode against a patient's skin with vacuum suction. The holder is also connectable to an electrical lead for connection to the electrode unit. The holder has a resilient cap which is moveable to actuate a valve to open communication through the holder from the vacuum source to a chamber adjacent the skin. To prevent the transfer of contaminants from the skin to reusable parts of the holder, a first contaminant absorber is provided within a housing of the holder and a second contaminant absorber is provided as part of the electrode unit. A second valve can be provided which is actuatable to close vacuum communication when second absorber expands to a threshold contamination condition.

Abstract: A system for reliably and accurately measuring the electrocardiographic waveform generated by a subject's cardiac muscle includes electrocardio electrodes that have multiple openings on their surfaces, a body contact determination circuit for determining if a subject is in physical contact with the electrocardio electrodes, a blow control circuit for causing air to flow out of the multiple openings of the electrocardio electrode when the subject is not in physical contact with the electrocardio electrodes and a suction control circuit for causing air to be sucked through the multiple openings of the electrocardio electrodes when the subject is in physical contact with the electrocardio electrodes. In a preferred embodiment, a pulse wave propagation velocity determining circuit is used to determine the propagation velocity of a subject's pulse wave.