Abstract: Transluminal methods and apparatus for causing arterial blood to flow through a vein of a mammalian patient, in a direction opposite normal venous blood flow, after an arterial blood containing conduit has been purposely or inadvertently connected to the vein. The method includes the use of a transluminally inserted vessel lumen occluding apparatus to at least partially block (e.g., occlude, embolize or close) the lumen of the vein at a location that is proximal to the location at which the arterial blood containing conduit is connected to the vein. The apparatus comprises a radially expandable lumen blocking device that is implantable in the vein lumen and catheters and other apparatus for implanting the radially expandable lumen blocking device into the lumen of the vein.

Abstract: An implantable device for reducing restenosis includes a structure including a polyamino acid component, wherein the polyamino acid component can be in the form of a coating or a film on the structure or it can be an integral part of the structure.

Abstract: An over-the-wire catheter provides substantially shadow-free delivery of radiation to a body lumen by having a treatment region wherein a guidewire tube and a radiation source tube form a parallel double helix configuration. When a radiation source is inserted into the radiation source tube and a guidewire is present in the guidewire tube, no portion of the treatment site will be obscured from all radiation emitted by the radiation source because, within the treatment region, the guidewire and the radiation source are not in a conventional, axially parallel configuration. Optionally, a balloon may be mounted about or adjacent the treatment region of the catheter, the balloon providing centering and/or dilatation functions.

Abstract: The invention provides a wireless automatic location identification (ALI) capable system (10), including a medical device (12) having a wireless data communicator (14), a wireless communication network (16), and a remote locating service (18) for remotely locating and monitoring one or more medical devices over the wireless communication network. When the medical device is linked to the remote locating service over the communication network, the ALI-capable system identifies the location of the medical device and relays the location information to the remote locating service. The system permits reliable determination of the location of the medical device wherever the medical device is situated. The medical device may further be configured to transmit signals indicative of its status, condition, or self-test results, to the remote locating service. This feature allows the remote locating service to centrally monitor the status or condition of a plurality of medical devices.

Abstract: A method and system for nodal rhythm detection and treatment is provided. Detecting consecutive atrial events within a nodal activity window around ventricular events identifies nodal rhythm. Nodal rhythm is treated by calculating and applying a new atrial escape interval adjusted by the interval between the atrial and ventricular events.

Abstract: A hand-holdable structure implementing electrodes to enable good skin-electrode contact to acquire ECG readings is disclosed. Specifically, the structure is shaped to enable patients to apply a simple gentle grip to have a reliable skin-electrode contact and to automatically commence ECG tracing transmission to a patient monitoring station. In one embodiment the structure incorporates an RF telemetry head to simultaneously transfer IMD stored data in conjunction with the ECG tracings. The structure independently or in combination with the RF telemetry head is adaptable to a system of data communications with a programmer or equivalent instrument to transfer ECG and IMD data to a remotely located physician station or patient data storage server. The system is also adaptable for use with a web-enabled network such as, without limitation, the Internet, intranet, World Wide Web, extranet or equivalent.

Abstract: The present invention provides a system for treating a blood vessel. The blood vessel treatment system includes a hollow guidewire having a central lumen, an occlusion balloon attached proximate to a distal end of the hollow guidewire, and an inflation catheter slidable over the hollow guidewire. An annular inflation lumen formed between the inflation catheter and the hollow guidewire fluidly communicates with the central lumen of the hollow guidewire, allowing inflation fluid to flow through the annular inflation lumen and into a distal portion of the central lumen to inflate the occlusion balloon.

Abstract: A method of generating a template in an implantable medical device for implantation within a patient, and a processor readable medium for performing the method, that includes generating a template corresponding to a supraventricular rhythm of the patient, determining whether the template is valid, and monitoring the template to determine whether the template is an accurate representation of the supraventricular rhythm. The template is created from non-paced R waves that are below a predetermined heart rate, and a statistical validation of the template is performed by evaluating the template based on matches against ongoing slow heart rhythm. The quality of the template is continuously monitored, similar to the statistical validation, with the exception that one thousand beats are evaluated and once more than thirty out of the last one hundred beats do not match the template within the threshold, an attempt is made to create a new template.

Abstract: An implantable lead for electrical stimulation of tissue has wire-like extendable members whose tips curl back upon themselves in open tissue spaces to form 2- or 3-dimensional electrodes. The electrodes may be positioned axially or in other directions from the lead body. Traction on the lead body or extendable members allows easy withdrawal as the member tip electrodes uncurl, allowing removal without major surgery. This apparatus and method is useful for minimally invasive insertion of electrodes or electrode arrays, especially through a narrow body lumen or Tuohy needle, providing therapeutic stimulation of nervous tissue, muscle or organs.

Abstract: An implantable drug infusion device includes a pump tube for holding a liquid to be pumped. A race is configured to support the pump tube. A roller assembly is configured to compress the tube against the race at one or more points along the path, and the roller assembly includes at least one roller and a hub. A drive assembly drives the roller assembly relative to the tube along the path so as to move the liquid through the tube. A retracting roller is operably connected to the hub and/or one or more adjacent rollers to permit retraction of the roller during installation of the pump tube between the roller and the race.

Abstract: A cardiac pacing system and method incorporate DSP processing and software algorithms for collecting signal amplitude data and noise data, and organizing the data for automatic checking of signal channel gain and signal detection sensitivity. Unfiltered signals are used to obtain values representative of maximum amplitude, which values are stored in a gain histogram, from which determination of the percentage of clipped signals can be made. Gain is adjusted by limiting clipping to a predetermined range of allowed clipping, to optimize use of the DSP range. The signals, both P waves and R waves for a dual chamber system, are also processed by DSP and parameters representing maximum amplitudes are stored in amplitude histograms. At the same time, noise is analyzed for respective windows of time following each ventricular event, and noise amplitude data is stored in noise histograms.

Abstract: This is a combination method and system for intravascularly accessing and visualizing a body structure. A system is disclosed comprising a sheath, a balloon catheter, and a catheter deflection mechanism. A micro-deflection mechanism, which may be placed into the lumen of devices such as cardiac leads or electrophysiology catheters, is also provided for accurate guidance and placement of such devices to their target location. In one embodiment, a procedure for a lead or catheter placement is described in which a combination deflection mechanism, balloon catheter, and sheath assembly access the coronary sinus ostium via a superior approach. A distal balloon on the catheter is inflated and an occlusive venogram is obtained under fluoroscopic guidance to visualize the coronary veins. The sheath is advanced into the coronary sinus ostium and the balloon is deflated. The catheter and deflection mechanism are then removed.

Abstract: An implantable medical catheter comprising at least one fluid passageway and a cured elastomer composition is disclosed. The cured elastomer composition is obtained by cross-linking an uncured blend composition that comprises an intimately admixed mixture that comprises the following components: (A) silica that had been silyliated by treatment and contains trialkylsilyl groups; (B) a polysiloxane copolymer; (C) a catalyst, and (D) an organohydrogen polysiloxane cross-linker, the catalyst and the cross-linker being present in the uncured blend composition in sufficient amount to cause the cross-linking reaction to occur.

Abstract: Methods and systems for monitoring the condition of a septum in an implantable medical device are disclosed. Monitoring of the septum provides the ability to determine whether a needle has pierced the septum to effect the transfer of fluids into or out of a reservoir in the implantable medical device. Septum monitoring may provide the ability to determine whether the septum is maintaining its ability to seal the reservoir against leakage. The systems of the present invention include an ultrasonic transducer acoustically coupled to the septum to emit ultrasonic energy directly into the septum. Insertion of a needle through the septum can be detected by the acoustical changes caused by the needle located within the septum.

Abstract: The invention is a method and apparatus for performing beating heart surgery, in which a single articulating arm supports multiple suction pods. Once the suction pods are applied to the heart surface, tightening a cable fixes the arm in place. Then, the suction pods may be spread apart from each other to tighten the surface of the cardiac tissue lying between the suction pods. In one embodiment, fixation of the arm as well as the spreading apart of the suction pods may occur concurrently or almost concurrently through the tensioning of a single cable. Additional embodiments of the method, system and its components are shown.

Abstract: A process for forming a heat weld between a catheter shaft and a surrounding balloon comprises selecting an elongate catheter shaft formed of thermoplastic polymeric material that is opaque to red and near-infrared light, and selecting a balloon formed of thermoplastic polymeric material that is transparent or translucent to red and near-infrared light. While a neck of the balloon is fitted in close contact around a distal portion of the catheter shaft, a laser beam of red and near-infrared light is applied through the balloon neck to impinge on the underlying opaque distal shaft, which is heated thereby. Heat from the shaft is conducted into the surrounding balloon neck so that adjacent annular portions of both components melt and mix. The molten materials are allowed to cool, forming a secure weld joint between the neck and the shaft. The process yields strong, flexible bonds between balloons and catheter shafts that may be selected from a wide variety of materials.

Abstract: A communication device (CD) exchanges messages with an implantable infusion pump via telemetry such that commands are supplied thereto and operational information is obtained therefrom. The CD is controlled, at least in part, by a processor IC according to a software program operating therein and provides feedback to a user via a visual display, an audio alarm, and a vibrational alarm, and allows input from the user via a touch sensitive keypad. Certain input functions are restricted by password. The visual display includes an icon and fixed element display region and a bitmap display region. The fixed element display region includes time and date displays, battery and drug level displays that decrement, and a moving delivery state display. Various screens allow operational or log information to be displayed and/or user entry of commands. Program features when disabled are removed from a series of screen options that can be scrolled through.

Abstract: An elongated coronary vein lead having a variable stiffness lead body and most preferably adapted to be advanced into a selected coronary vein for delivering a pacing or defibrillation signal to a predetermined region of a patient's heart, such as the left ventricle is disclosed. A method of pacing and/or defibrillating a patient's heart using the lead is also described. The method of pacing or defibrillating the heart includes advancing the coronary vein lead through both the coronary sinus and into a selected coronary vein of a patient's heart, connecting the lead to an electrical pacing source and applying electrical stimulation to a particular chamber of the patient's heart via the implanted lead. The lead includes a variable stiffness lead body that enhances the ability of the lead to be retained in a coronary vein after the lead has been implanted therein.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Abstract: A programming-device user interface may include multiple levels of abstraction for programming treatment settings. A stimulation zone-programming interface may be at a highest level of abstraction and may include idealized stimulation zones. A field strength-programming interface may be at a middle level of abstraction and may include electromagnetic field-strength patterns generated by the stimulation zones, and/or electrode settings, and a depiction of how the electromagnetic fields interact with each other. An electrode-programming interface may be at a lowest level of abstraction and may depict treatment settings at an electrodes-view level. These interfaces may include a display of a stimulatable area of the patient's body. The display may include a depiction of leads and/or the underlying physiology, such as a depiction of a portion of a spine. Algorithms map treatment settings from one level of abstraction to settings at one or more other levels of abstraction.