Abstract: Medical devices for closing anatomical apertures, such as atrial or ventricular septal defects, are disclosed. The medical devices can include a plug body having a proximal end, a distal end, and a longitudinal axis. The plug body can include an exterior surface, an interior surface defining an interior lumen, and a seal which can be located within the interior lumen. The medical devices can also include at least one arm member extending through the plug body between the exterior surface and the interior surface of the plug body. In certain embodiments, the medical device can include a distal loop and a proximal loop extending through the plug body. In certain embodiments, the proximal loop can be smaller than the distal loop, such that a top end and a bottom end of the proximal loop can fit within a top end and a bottom end of the distal loop.

Abstract: Method and systems of determining adequacy of fixation of a medical lead type having a fixation helix are disclosed. The lead of the medical lead type is placed at a desired location within a patient's body and the fixation helix is screwed into tissue at that location. One or more parameters, associated with the lead, are measured at the location. Based upon the measured one or more parameters, determining a number of turns that the helix is embedded into the tissue at the location.

Abstract: A positioning device for providing access to a ventricle of a heart. In one embodiment, the device includes a cup positionable over an apex of the heart and at least a first access valve in the cup for accessing an entry point to the ventricle of the heart.

Abstract: A method and system for providing lesion depth feedback during an ablation procedure. In particular, the method and system provide feedback data or information relating to lesion depth in myocardial tissue during a cryoablation procedure. A plurality of tissue temperature measurements may be transmitted from a plurality of thermocouples disposed on a cryotreatment element, which measurements may be used to determine a slope of change in temperature sensed by each thermocouple over time. The circulation of coolant through the treatment element may be adjusted when the slope changes. A change in slope may indicate that the cryoablation temperatures have passed through target myocardial tissue into non-target, non-myocardial tissue, which may result in collateral damage to structures near the heart.

Abstract: An isolated heart or heart-lung preparation in which essentially normal pumping activity of all four chambers of the heart is preserved, allowing for the use of the preparation in conjunction with investigations of electrode leads, catheters, ablation methods, cardiac implants and other medical devices intended to be used in or on a beating heart. The system can be designed to be used within a Magnetic Resonance Imaging (MRI) unit or a X-ray computed tomography (CT) scanner. The preparation may also be employed to investigate heart and lung functions, in the presence or absence of such medical devices. In order to allow comparative imaging visualizations of either or simultaneously the heart and/or lung structures and devices located within the chambers of the heart or vessels or bronchi within the lungs, a clear perfusate such as a modified Krebs buffer solution with oxygenation is circulated through all four chambers of the heart and thus the coronary and/or pulmonary vasculatures.

Abstract: A method for closing an opening at a target site including bodily tissue including embedding a plurality of self-closing clips into the target site in a spaced apart manner about a perimeter of the opening. Each of the clips has opposing clip ends and an intermediate segment. A flexible tether is coupled to the embedded clips to form a loop about the opening perimeter. A pulling force is applied onto at least one of the loop ends, thereby drawing the perimeter of the opening onto itself to completely close the opening. The loop ends are secured to maintain the target site in a closed state. In some embodiments, the target site is apical cardiac tissue, and the method is performed as part of a trans-apical access procedure.

Abstract: Medical devices for closing anatomical apertures, such as atrial or ventricular septal defects, are disclosed. The medical devices can include a plug body having a proximal end, a distal end, and a longitudinal axis. The plug body can include an exterior surface, an interior surface defining an interior lumen, and a seal which can be located within the interior lumen. The medical devices can also include at least one arm member extending through the plug body between the exterior surface and the interior surface of the plug body. In certain embodiments, the medical device can include a distal loop and a proximal loop extending through the plug body. In certain embodiments, the proximal loop can be smaller than the distal loop, such that a top end and a bottom end of the proximal loop can fit within a top end and a bottom end of the distal loop.

Abstract: A method for delivering physiological pacing includes selecting an electrode implant site for sensing cardiac signals, which is in proximity to the heart's intrinsic conduction system, where pacing stimulation results in a rhythm breaking out at an intrinsic location, and selected in response to a ratio of sensed P-wave amplitude to sensed R-wave amplitude.

Abstract: A medical electrical lead includes a glue segment to adhere the lead to a treatment site. The glue segment, which may be disposed within a tip electrode of the lead, includes tissue adhesive which may encapsulated within a capsule.

Abstract: A positioning device for providing access to a ventricle of a heart. In one embodiment, the device includes a cup positionable over an apex of the heart and at least a first access valve in the cup for accessing an entry point to the ventricle of the heart.

Abstract: A method for closing an opening at a target site including bodily tissue including embedding a plurality of self-closing clips into the target site in a spaced apart manner about a perimeter of the opening. Each of the clips has opposing clip ends and an intermediate segment. A flexible tether is coupled to the embedded clips to form a loop about the opening perimeter. A pulling force is applied onto at least one of the loop ends, thereby drawing the perimeter of the opening onto itself to completely close the opening. The loop ends are secured to maintain the target site in a closed state. In some embodiments, the target site is apical cardiac tissue, and the method is performed as part of a trans-apical access procedure.

Abstract: A method for delivering physiological pacing includes selecting an electrode implant site for sensing cardiac signals, which is in proximity to the heart's intrinsic conduction system, where pacing stimulation results in a rhythm breaking out at an intrinsic location, and selected in response to a ratio of sensed P-wave amplitude to sensed R-wave amplitude.

Abstract: A method for delivering physiological pacing includes selecting an electrode implant site within an interventricular septal zone, which is in proximity to the bundle of His where pacing stimulation results in a rhythm breaking out at an intrinsic location, and wherein a ratio of sensed P-wave amplitude to sensed R-wave amplitude is less than approximately 0.5 and a pacing threshold is less than or equal to approximately 1.5 volts.

Abstract: A method for an operator to handle a rake includes gripping, with a first hand, a handle of the rake in proximity to a mid-shaft portion of the handle, and gripping, with a second hand, the handle of the rake in close proximity to a free end of the handle such that a line extending across the row of teeth, being approximately perpendicular to the extension of a centrally located tooth of the row of teeth, forms an angle of less than ninety degrees with portions of the handle, the angle being on a first lateral side of the rake head that is adjacent to the operator.

Abstract: An ergonomic rake includes a handle extending from a free end through a mid-shaft portion, which includes first and second gripping locations. A head of the rake includes a row of teeth extending distally therefrom and is coupled to a coupling end of the handle such that a line extending across the row of teeth forms an angle of less than ninety degrees with the first and second gripping locations.

Abstract: A method for delivering physiological pacing includes selecting an electrode implant site within an interventricular septal zone, which is in proximity to the bundle of His where pacing stimulation results in a rhythm breaking out at an intrinsic location, and wherein a ratio of sensed P-wave amplitude to sensed R-wave amplitude is less than approximately 0.5 and a pacing threshold is less than or equal to approximately 1.5 volts.

Abstract: An isolated heart preparation in which essentially normal pumping activity of all four chambers of the heart is preserved, allowing for the use of the preparation in conjunction with investigations of electrode leads, catheters, cardiac implants and other medical devices intended to be used in or on a beating heart. The preparation may also be employed to investigate heart functions, in the presence or absence of such medical devices. In order to allow for visualization of heart structures and devices located within the chambers of the heart, a clear perfusate such as a modified Krebs buffer solution with oxygenation is circulated through all four chambers of the heart and the coronary vasculature. The preparation and recordings of the preparation may be used in conjunction with the design, development and evaluation of devices for use in or on the heart, as well as for use as an investigational and teaching aid to assist physicians and students in understanding the operation of the heart.

Abstract: A medical lead is adhered to a tissue site using a tissue adhesive.

Abstract: A system and method for positioning an implantable medical device (IMD) within a living body is disclosed. The IMD includes a flow-directed member that is deployed within the body to carry the IMD via the flow of blood. The flow-directed member may be an inflatable member such as a balloon, or a mechanical member such as a parachute structure that deploys within the body. The IMD further includes a pressure measuring device and a pressure monitor to obtain pressure measurements at one or more locations within the body adjacent the IMD. The pressure measurements are used to estimate the location of at least a portion of the IMD relative to the body to aid in positioning the IMD in the body without the use of a fluoro-visible media.

Abstract: An improved system for monitoring the status of an IMD such as a medical electrical lead during an implant procedure is provided. The system includes a signal generator for supplying a first signal such as a constant current or voltage to the IMD. A resulting voltage or current signal is generated, respectively, and may be sensed as an indication of the impedance of a portion of the body that is proximal to one or more electrodes carried by the lead. This impedance indication is converted to an audible signal having a frequency that is proportional to the amplitude of the impedance indication. The pitch of the audible signal therefore rises when measured impedance increases, and drops as the impedance decreases. These pitch changes allow a user to determine positional information associated with the IMD, including the degree of lead tissue contact and extent of fixation of a device to tissue.