Abstract: A remotely controlled insertion system for a medical device is described. The system comprises a robotic device and a remote control mechanism. The robotic device has a handle controller to receive and hold the control handle or proximal end of a medical device. The medical device is capable of moving in up to six ranges of motion. In one embodiment a first motor is connected through a drive screw to a handle controller to move the medical device forward and backward. A second motor is connected to drive wheels effective to rotate the medical device clockwise and counter-clockwise. A third motor drives a series of gears that are connected to one or more control members on the medical device, this being effective to deflect a tip of the medical device so that movement of the third motor causes such deflection. A control unit is connected to all three motors.

Abstract: A steerable catheter system to perform a transseptal puncture procedure comprises a steerable catheter shaft with at least one inner lumen, and an inner element slidably positioned within a shaft lumen, wherein the distal tip of the shaft can be deflected, counter-deflected, rotated, and counter-rotated and wherein the inner element can be deployed or retracted. In one embodiment, a single steerable catheter is capable of performing an intended procedure and a transseptal procedure all in one, wherein the catheter comprises an outer steerable catheter and an inner element which can be deployed to perform a transseptal puncture, and wherein, once the inner element crosses the inter-atrial septum, the catheter itself can slide forward without advancement of the inner element.

Abstract: A shielded head cover in accordance with an embodiment of the present application includes at least one attenuation portion including a radiation attenuating material configured and operable to protect a user head from radiation. The attenuation portion includes a varying amount of radiation attenuating material at different locations to provide for increased protection at desired locations. The attenuation portion may be embodied as a removable patch that is attached to the head cover. The attenuation portion may be provided by spraying particles of radiation attenuating material on the head cover.

Abstract: A shielded head cover in accordance with an embodiment of the present application includes at least one attenuation portion including a radiation attenuating material configured and operable to protect a user head from radiation. The attenuation portion may include a varying amount of radiation attenuating material at different locations to provide for increased protection at desired locations. The attenuation portion may be embodied as a removable patch that is attached to the head cover. The attenuation portion may be provided by spraying particles of radiation attenuating material on the head cover. The attenuation portion may be embodied as a headband configured to be wrapped around a user's head and including attenuating material positioned in a pocket or cavity therein.

Abstract: A pacing system includes a controller operable to provide control signals indicating desired pacing signals, a pulse generator connected to the controller and operable to receive the control signals and to generate the desired pacing signals based on the control signals, at least one lead electrically connected to the pulse generator and extending into a user's heart and operable to provide the pacing signals to the heart, at least one electrode positioned in the user's heart and electrically connected to the at least one lead, the at least one electrode in contact with the user's heart and operable to stimulate the heart based on the pacing signals; and a transceiver, in communication with the pulse generator and operable to selectively transmit the pacing signals to the electrode wirelessly. The transceiver is controlled by the controller to transmit the pacing signals when pacing signals are not received by the electrode from the at least one lead.

Abstract: A remotely controlled insertion system for a medical device is described. The system comprises a robotic device and a remote control mechanism. The robotic device has a handle controller to receive and hold the control handle or proximal end of a medical device. The medical device is capable of moving in up to six ranges of motion. In one embodiment a first motor is connected through a drive screw to a handle controller to move the medical device forward and backward. A second motor is connected to drive wheels effective to rotate the medical device clockwise and counter-clockwise. A third motor drives a series of gears that are connected to one or more control members on the medical device, this being effective to deflect a tip of the medical device so that movement of the third motor causes such deflection. A control unit is connected to all three motors.

Abstract: A system for remotely controlling the positioning within the body of a patient of an elongated medical device optionally having a control handle, comprises a robotic system and a remote controller configured to control the robotic device. The robotic system comprises a handle controller; a sled member coupled to the handle controller, the sled member being configured to position the medical device within the body of the patient; and a sled base configured to advance the sled member towards the body of a patient, the sled bed being coupled to a sterile barrier effective to maintain sterility inside the sled base. A medical device introducer is effective to guide the elongated medical device into a patient's body.

Abstract: A system for monitoring a patient and treating the malfunctioning heart of the patient, either in an automatic mode or in a semiautomatic mode, includes means which derive at least one physiologic signal from or related to the patient's circulatory system representative of hemodynamic status. A feedback loop is implemented in a biventricular implant, in order to automatically or selectively optimize the patient's clinical hemodynamic status. Accordingly, the biventricular implant will be programmed to go through a series of AV delay, RV-LV timing and heart rate sequences which scan a preselected range of programmable values and apply those values to the patient's heart. Hemodynamic patient measurements will be recorded and preferably graphed over those applied values.

Abstract: A device for performing active compression/decompression cardiopulmonary resuscitation includes an applicator body with an upper surface and a lower surface. The lower surface includes provisions for detachably securing to the patient's chest, such as a vacuum cup or an adhesive layer. For manual resuscitation, the upper surface will include a strap or other structure for securing a performer's hand thereto. In an exemplary device, a disc-shaped handle is attached to the upper surface of a vacuum cup applicator by a short connecting stem structure. A pressure gauge mounted to the handle permits the performer to monitor how much force is being applied in both the compression and decompression phases. For automatic applications, a mechanical drive member will be secured to the upper surface. By alternately pressing and lifting on the applicator device, the patient's chest can be compressed and expanded to improve induced ventilation and circulation.

Abstract: A method for performing cardiopulmonary resuscitation employs an applicator device having a body with an upper surface and a lower surface. The lower surface includes provisions for detachably securing to the patient's chest, such as a vacuum cup or an adhesive layer. For manual resuscitation, the upper surface will include a strap or other means for securing a performer's hand thereto. For automatic applications, a mechanical drive member will be secured to the upper surface. By alternately pressing and lifting on the applicator device, the patient's chest can be compressed and expanded to improve induced ventilation and circulation.

Abstract: A transesophageal defibrillating system includes a large area anterior patch electrode and a large area posterior patch electrode, as in some conventional exterior defibrillating systems. An esophageal probe has a pair of ring electrodes, one of which is carried at or near its distal end. The system is operatively arranged to supply defibrillation pulses between the large anterior patch electrode and either the distal electrode (carried by the probe) or the large posterior electrode, depending on which one of the latter two electrodes is connected or coupled by the clinician or paramedic to the defibrillating pulse source. The system includes a source of pacing pulses which may be supplied to the patient via the anterior patch electrode and at least one of the electrodes carried by the esophageal probe. The distal electrode is believed to be the more effective electrode to use for this purpose.

Abstract: A system for treating the malfunctioning heart of a patient includes means which derive at least one electrical signal from the patient's heart and means which derive at least two physiologic signals from or related to the patient's circulatory system. The physiologic signals, or functions thereof, are weighted and algebraically summed in a central processing unit, which may be a programmable microprocessor, having a RAM and a ROM, receives and responds to the at least one electrical signal and to the at least two physiologic signals. Output means, which may include a heart assist pump, pacers, drug delivery devices and cardioverting/-defibrillating apparatuses, controlled by the central processing unit provides corrective measure(s) to the patient. Heart-rate zone signals and the algebraic sum, at any given time effect selection of a particular treatment modality, if needed.

Abstract: A system for monitoring a patient and treating the malfunctioning heart of the patient, either in an automatic mode or in a semiautomatic mode, includes means which derive at least one electrical signal resulting from action of the patient's heart and means which derive at least one physiologic signal from or related to the patient's circulatory system. A central processing unit, which may be a programmable microprocessor, with a RAM and a ROM, receives and responds to the at least one electrical signal and to the at least one physiologic signal. Output means, which may include a heart assist pump, pacers, drug delivery devices and cardioverting/-defibrillating apparatuses, controlled by the central processing unit provides corrective measure(s) to the patient. Adjustable or variable baselines, against which a representation of the current, short-term magnitude of the selected physiologic parameter or parameters are provided.

Abstract: A system for treating a malfunctioning heart is based on hemodynamics, the pressure at a site in a patient's circulatory system being sensed. A signal is developed representative of short term mean arterial pressure (MAP), mean right atrial pressure (MRAP), mean right ventricle pressure (MRVP), mean left atrial pressure (MLAP), mean left ventricle pressure (MLVP), mean central venous pressure (MCVP), mean pulmonary artery pressure (MPAP), mean pulmonary vein pressure (MPVP), mean pulmonary capillary wedge pressure (MPCWP), right ventricular systolic pressure (RVSP), right ventricular end diastolic pressure (RVEDP), or right ventricular pulse pressure (RVPP). A signal representative of fixed or varying baseline pressure is provided and if the short term current pressure differs therefrom by a predetermined value, an indication of hemodynamic compromise, cardioversion/defibrillation is effected.

Abstract: A system for treating the malfunctioning heart of a patient includes means which derive at least one electrical signal from the patient's heart and means which derive at least one physiologic signal from or related to the patient's circulatory system. A central processing unit, which may be a programmable microprocessor, with a RAM and a ROM, receives and responds to the at least one electrical signal and to the at least one physiologic signal. Output means, which may include a heart assist pump, pacers, drug delivery devices and cardioverting/defibrillating apparatuses, controlled by the central processing unit provides corrective measure(s) to the patient. Adjustable or variable baselines, against which a representation of the current, short-term magnitude of the selected physiologic parameter or parameters are provided.

Abstract: A system for and method of treating a malfunctioning heart is based on hemodynamics, the O.sub.2 in blood at a site in a patient's circulatory system being sensed. A signal is developed representative of short term O.sub.2 level in the blood preferably at a site which carries mixed venous blood. A signal representative of a baseline O.sub.2 level (fixed or varying) is provided and if the short term current O.sub.2 level differs therefrom by a predetermined value, an indication of possible hemodynamic compromise. The heart rate is sensed and signals develop indicative of which of a number of rate ranges into the current rate falls. One or another or more than one of a plurality or heart malfunction corrective inputs to the patient are delivered, as needed. The system may include a failsafe antibradycardia pacemaker, if desired.

Abstract: A system for a method of treating a malfunctioning heart is based on hemodynamics, the pressure in the right side of a patient's circulatory system being sensed. A first signal is developed representative of mean right atrial pressure (MRAP) and a second signal is developed representing right ventricular systolic pressure (RVSP). When the MRAP increases by at least a predetermined amount and the RVSP decreases at least a given amount, the combination being an indication of hemodynamic compromise, cardioversion/defibrillation is effected. In these cases, a heart rate criterion, for example a rate over 150 bpm, may also have to be met before cardioverting/defibrillation is initiated. Fixed or variable baselines against which the changes in pressure are measured may be provided.

Abstract: A system for and method of treating a malfunctioning heart is based on hemodynamics, the pressure in the right side of a patient's circulatory system being sensed. A first signal is developed representative of mean right atrial pressure (MRAP) and a second signal is developed representing right ventricular systolic pressure (RVSP). When the difference (or ratio) between MRAP and RVSP reaches at least a predetermined value, the combination being an indication of hemodynamic compromise, cardioversion/defibrillation is effected. In these cases, a heart rate criterion, for example a rate over 150 bpm, may also have to be met before cardioverting/defibrillation is initiated. Fixed or variable baselines against which the predetermined value is to be measured may be provided. Other hemodynamic parameters, such as RVDP, RVSP, MRVP and/or MAP could be used as one or another of the hemodynamic parameters.

Abstract: A system for and method of treating a malfunctioning heart is based on hemodynamics, the pressure at a site in a patient's circulatory system being sensed. A signal is developed representative of short term mean arterial pressure (MAP) or right ventricular systolic pressure (RVSP), or right ventricular pulse pressure (RVPP). The rate of change and direction of the rate of change is determined and, if the rate of change in a given direction exceeds a predetermined amount, an indication of possible hemodynamic compromise, cardioversion/defibrillation is effected.

Abstract: A system for treating the malfunctioning heart of a patient includes means which derive at least one electrical signal from the patient's heart and means which derive at least one physiologic signal from or related to the patient's circulatory system, a central processing unit with a RAM and a ROM, receives and responds to the at least one electrical signal and to the at least one physiologic signal. Output means controlled by the central processing unit provides corrective measure(s) to the patient. A method of treating the malfunctioning heart of a patient, includes deriving at least one electrical signal from the patient's heart, deriving at least one physiologic signal from or related to the patient's circulatory system, processing the at least one electrical signal and the at least physiologic signal, and providing a corrective measure or measures to the patient whenever a malfunction is identified.