Abstract: A system for monitoring and/or affecting parameters of a patient's body and more particularly to such a system comprised of a system control unit (SCU) and one or more other devices, preferably battery-powered, implanted in the patient's body, i.e., within the envelope defined by the patient's skin. Each such implanted device is configured to be monitored and/or controlled by the SCU via a wireless communication channel. In accordance with the invention, the SCU comprises a programmable unit capable of (1) transmitting commands to at least some of a plurality of implanted devices and (2) receiving data signal from at least some of those implanted devices. In accordance with a preferred embodiment, the system operates in closed loop fashion whereby the commands transmitted by the SCU are dependent, in part, on the content of the data signals received by the SCU.

Abstract: A system and method for bracketing a tissue volume (22) and later locating the bracketed tissue volume. The system includes a plurality of markers (30) and a probe (32) and detector (34) for use in locating the markers by providing information usable by a surgeon that is representative of changes in proximity between the probe and the plurality of markers. The markers have various detection characteristics, e.g., they transmit gamma rays, that are detectable by an associated probe and detector. The tissue volume is removed by manipulating a cutting tool based on the proximity information provided by the detector which can be used by the surgeon to define the boundary of the tissue volume. A two-part cutting tool (200) is provided for removing the tissue volume, and a tissue anchor (300) is provided for stabilizing the tissue during removal. The system and method of the invention are particularly useful in bracketing and then removing a tissue volume from amorphous, pliable tissue such as breast tissue.

Abstract: A control assembly for guiding the placement of an endotracheal tube during the intubation of a patient comprising a flexible stylet comprising a first magnet distally disposed on the stylet and an alignment fixture comprising a second magnet and adapted for positioning the second magnet over the cricothyroid cartilage of the patient to be intubated and retaining the second magnet in position over the cricothyroid cartilage of the patient.

Abstract: Biomaterial, for example bioactive silicon, may be fabricated by anodizing a silicon wafer to produce a wafer having a porous silicon region. In vitro experiments have shown that certain types of porous silicon cause the deposition of apatite deposits both on the porous silicon and neighboring areas of bulk silicon when immersed in a simulated body fluid solution. This deposition of apatite provides an indication that porous silicon of appropriate form is bioactive, and therefore also biocompatible. A form of porous silicon is dissolved in the simulated body fluid solution and this is an indication of a resorbable biomaterial characteristic. In addition to porous silicon, certain types of polycrystalline silicon exhibit bioactive characteristics. Bioactive silicon may be used in the fabrication of biosensors for in vitro or in vivo applications. The bioactivity of the bioactive silicon may be controlled by the application of an electrical potential thereto.

Abstract: A system for delivery of high dosage of radiation to a targeted spinal area is provided. This is accomplished by a system which provides for precise immobilization and positioning of the treated spinal area during dose planning and treatment via stereotactic radiosurgery. Advantages of the system include convenience to the patient, enhanced efficacy, and reduced risk of radiotoxicity to non-target tissues.

Abstract: Apparatus and methods for retrieving a vascular filter from a vessel are provided wherein a retrieval adapter is delivered to a treatment site concurrently along with an interventional device to reduce the number of steps required to remove the vascular filter. The retrieval adapter also reduces the possibility of entangling the vascular filter with a stent disposed within the vessel during removal of the vascular filter. A separate retrieval catheter is also described for use in conjunction with the retrieval adapter.

Abstract: A system and method for tracking the position and orientation of a probe such as a catheter whose transverse inner dimension may be at most about two millimeters. Three planar antennas that at least partly overlap are used to transmit electromagnetic radiation simultaneously, with the radiation transmitted by each antenna having its own spectrum. In the case of single-frequency spectra, the antennas are provided with mechanisms for decoupling them from each other. A receiver inside the probe includes sensors of the three components of the transmitted field, with sensors for at least two of the three components being pairs of sensors, such as coils, disposed symmetrically with respect to a common reference point. In one variant of the receiver, the coils are collinear and are wound about cores that are mounted in pairs of diametrically opposed apertures in the housing of the probe.

Abstract: When a capsule is manufactured, a unique number such as a serial number is stored in non-volatile memory in the capsule. If the capsule is used with an external apparatus, the unique number is sent from the capsule to the external apparatus. The external apparatus relates each unique number with a capsule ID comprising a small number of bits in a management table formed in non-volatile memory and sends the capsule ID to the capsule, and the capsule ID with the small number of bits is set as an identifier in the capsule. In this manner, it is made unnecessary to provide a switch in the capsule for setting the identifier and it becomes possible to reduce and send the quantity of information sent as the identifier.

Abstract: An apparatus for the automatic performance of diagnostic and/or therapeutic actions in body cavities is provided with a base control unit, which is to be arranged extracorporally, and with a catheter-type actuator, which is coupled therewith and which is insertable in the corresponding body cavity and which, in the vicinity of its distal end, is provided with a diagnostically active detection equipment and/or a therapeutically active treatment equipment, and which, at least in the vicinity of its distal end, is provided with an actuation mechanism, which is triggered by the base control unit, for advance and/or twist and turn control of the actuator.

Abstract: Implantable medical device telemetry is provided between an implantable medical device and an external communication device. The implantable medical device includes a device transmitter and/or a device receiver. The external communication device includes a moveable communication head including an antenna therein connected to at least one of an external transmitter and/or an external receiver for communication with the device transmitter and/or the device receiver of the implantable medical device. A user moves the moveable head apparatus relative to the implantable medical device. Tactile feedback is provided to the user via the moveable head apparatus upon movement of the moveable head apparatus to a position where valid telemetry can be performed.

Abstract: A system and method for efficiently and relatively inexpensively providing a capability of translating “Patient Session Information” comprising IMD data and patient data stored in IMD memory in one human language and optionally other patient data from other sources into another human language. The local language translation is effected by first employing an Extensible Mark-up Language (XML) converter for converting Patient Session Information from an initial format, such as a memory dump format, ASCII format, a waveform format, a numeric format, or a binary format, to an XML format, thereby providing XML formatted Patient Session Information. Then, the XML formatted Patient Session Information is subjected to transformation by a human language specific Extensible Stylesheet Language (XSL) stylesheet into XSL transformed Patient Session Information.

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: A telemetric medical sensor for implantation in a patient's body for measuring a parameter therein is provided. The sensor comprises a housing and a membrane at one end of the housing. The membrane is deformable in response to the parameter being measured. A microchip is positioned within the housing and operatively communicates with the membrane for transmitting a digital signal indicative of the parameter. The microchip comprises an array of photoelectric cells for use with an LED for transmitting light at the photoelectric cells. A shutter is connected to the membrane and moveable between the photoelectric cells and the LED in response to deforming of the membrane.

Abstract: Instrumentation and methods are provided for mounting a surgical navigation reference frame to a patient for performing an image-guided surgical procedure on an anatomical component. In one embodiment of the invention, a trocar is positioned within a cannula to form an insertion device adapted for percutaneous introduction into the patient. A bone anchor having a bone engaging portion is inserted through the cannula and is anchored to bone. The bone anchor cooperates with the cannula to form a mounting device adapted for coupling with the surgical navigation reference frame. In one embodiment of the invention, an image-guided surgical procedure is performed at a location remote from the anchoring location. In a specific embodiment, an image-guided surgical procedure is performed adjacent the spinal column, with the bone engaging portion of the bone anchor anchored to the iliac region of the pelvic bone, and more specifically to the iliac crest of the pelvic bone.

Abstract: A seal adapted for use with medical devices is provided. The medical device may be a lead having a distal tip adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead assembly in one embodiment includes an atraumatic tip. A seal is provided within the lead tip assembly, which prevents or limits further entry of fluids through the lead tip. The lead may be a left ventricular lead with a hemostasis mechanism provided therewithin.

Abstract: The invention relates to a device to seal and lubricate instruments inserted into trocar tubes, having a sealing cover that can be connected to fit exactly to the insertion end of the trocar tube and has at least one lining lip. The invention is characterized in that a member of porous or fleece-type material that can be moistened with a lubricating agent is mounted in the sealing cover and engages at least partially with the outer circumference of an introduced instrument.

Abstract: A method and apparatus for communicating with and monitoring the operation of a device implanted within a patient. A transceiver capable of being implanted within a patient provides a communication interface between an implanted medical device and a monitor external to the patient's body. The external monitor can communicate with a remote monitoring center over a communication network. The external monitor also provides control signals to the implanted device via the transceiver unit. The transceiver apparatus is capable of two-way communication between the implanted device and the external monitor. The transceiver apparatus is also capable of detecting actions performed by the implanted device and physiological signals directly from the patient's body. Thus, the transceiver apparatus provides a means for determining whether an implanted medical device is operating properly. The transceiver apparatus provides a way to remotely reprogram one or more implanted medical devices.

Abstract: A system for determining the disposition of a probe within the body of a patient includes a probe having probe field transducers and a plurality of reference field transducers. The reference field transducers are independently movable with respect to one another to desired, customizable positions close to the body of the patient. Calibration transducers determine the relative positions of the field transducers with respect to one another after they are located in their desired positions. Non-ionizing fields are transmitted and detected between the probe and reference field transducers. From the detected fields, the relative disposition of the probe with respect to the reference field transducers is determined.

Abstract: Apparatus for stimulating neuromuscular tissue of the gastrointestinal tract and methods for installing the apparatus to the surface of the neuromuscular tissue. A pair of electrodes are supported by an electrode attachment member having a distal surface configured for attachment to the surface of the neuromuscular tissue. The electrodes are supported adjacent the distal surface to provide an interface between the electrodes and the surface of the neuromuscular tissue. The electrode attachment member may be flexible to pass through a laparoscopic surgical access opening in a compacted form and then returned to an uncompacted form for attachment to the surface of the neuromuscular tissue by the use of staples or sutures.

Abstract: A method of aiding the compression and relaxation of a heart chamber using ferromagnetic and diamagnetic pellets inserted into the anterior and posterior walls of the chamber is provided. The pellets are inserted into the myocardial walls of the heart chamber by means of a delivery catheter. Electromagnetic fields, which are used to push and pull the pellets to compress and relax the hear chamber, are cyclically generated by electromagnetic field generators positioned on a patient's chest and back wall.

Abstract: Apparatus and methods are disclosed for reducing the potentially harmful effects of electromagnetic waves on an implantable medical device. In one embodiment of the present invention, an implantable medical system comprising a dual threshold magnetic sensor capable of detecting an elevated magnetic field is disclosed. The sensor can comprise a solid-state sensor capable of detecting a static magnetic field in excess of about 1500 Gauss. The magnetic sensor can be operatively coupled to electronics that are capable of altering the operation of the system upon detection of an elevated magnetic field by the magnetic sensor.

Abstract: Implantable medical device telemetry is provided between an implantable medical device and an external communication device. The implantable medical device includes a device transmitter and/or a device receiver. The external communication device includes a moveable communication head including an antenna therein connected to at least one of an external transmitter and/or an external receiver for communication with the device transmitter and/or the device receiver of the implantable medical device. A user moves the moveable head apparatus relative to the implantable medical device. Tactile feedback is provided to the user via the moveable head apparatus upon movement of the moveable head apparatus to a position where valid telemetry can be performed.

Abstract: The progress of a endovascular aneurysm repair can be monitored by inserting a pressure transducer sensor using a catheter into the sac during endovascular aneurysm repair and then using a small, hand-held read out device to measure pressure easily, safely, inexpensively and accurately. In one aspect a sensor is introduced into the body by the steps of folding or rolling the sensor into a cylinder, loading it into a catheter, and deploying into the aneurysm sac by allowing it to unroll or unfold, either by itself or facilitated by the incorporation of a super-elastic alloy component.

Abstract: An apparatus and method for identifying a body member during a body intrusive procedure includes infrared light energy which is applied to the body member. Substantially visible infrared free light is introduced into the region. The body member is located by detecting the infrared light energy applied thereto. The infrared light energy may be applied to the body member via a light guide which is inserted into or placed in contact with the body member. In addition, a body member to be located may be illuminated from one side and the location of the illuminator detected by a probe on the other side of the body member.

Abstract: This reinforcement consists of a reinforcement piece (2) and of a flap (3) connected to this reinforcement piece (2); the reinforcement piece (2) is made of a prosthetic knit and has a slit (5) for its engagement around the spermatic cord; the flap (3) is able to be folded over the slit (5).

Abstract: A method and apparatus for generating a controlled torque of a desired direction and magnitude in an object within a body, particularly in order to steer the object through the body, such as a catheter through a blood vessel in a living body, by producing an external magnetic field of known magnitude and direction within the body, applying to the object a coil assembly including preferably three coils of known orientation with respect to each other, preferably orthogonal to each other, and controlling the electrical current through the coils to cause the coil assembly to generate a resultant magnetic dipole interacting with the external magnetic field to produce a torque of the desired direction and magnitude.

Abstract: A magnetic injection port assembly for a tissue expander system or similar inflatable medical device. The injection port assembly includes an injection port body having a cavity, a needle guard assembly, and a magnetic material therein. The needle guard assembly is positioned to prevent a hypodermic needle from passing through the medical device or interfering with the magnetic material. The magnetic material is affixed to the injection port body outside the cavity and the needle guard assembly. The magnetic material is spatially aligned with the region of the body into which the needle should be inserted so that this region may be located by locating the magnet with an external, non-invasive magnetic detection device.

Abstract: The present invention relates to methods for treating chlamydial infection comprising administering to a subject suffering from a chlamydial infection a bactericidal permeability-inducing (BPI) protein product.

Abstract: This invention is an improved tissue localizing device for fixedly yet removably marking a volume of tissue containing a suspect region for excision without penetrating that volume. This invention also encompasses methods for deployment of the localizing device and its excision along with the marked tissue volume. At least one locator element is deployed into tissue and assumes a predetermined curvilinear shape to define a tissue border containing a suspect tissue region along a path. The locator element path preferably encompasses the distalmost portion of the tissue volume without penetrating that volume. Multiple locator elements may be deployed to further define the tissue volume along additional paths defining the tissue volume border that do not penetrate the volume. Polar and tangential deployment configurations as well as a locator element that may be cold-formed by a die in the distal portion of the deployment tube into a permanent arcuate shape is also disclosed.

Abstract: A system for monitoring and/or affecting parameters of a patient's body and more particularly to such a system comprised of a system control unit (SCU) and one or more other devices, preferably battery-powered, implanted in the patient's body, i.e., within the envelope defined by the patient's skin. Each such implanted device is configured to be monitored and/or controlled by the SCU via a wireless communication channel. In accordance with the invention, the SCU comprises a programmable unit capable of (1) transmitting commands to at least some of a plurality of implanted devices and (2) receiving data signal from at least some of those implanted devices. In accordance with a preferred embodiment, the system operates in closed loop fashion whereby the commands transmitted by the SCU are dependent, in part, on the content of the data signals received by the SCU.

Abstract: An apparatus for the three-dimensional spatial registration of components of a surgical procedure. At least one radio tag is incorporated into a medical device. The at least one radio tag provides a radio signal source to a radio receiver for determining the position of the signal source. A central control unit includes software controls for providing information concerning the position of the signal source, and data is communicated between the central control unit and radio receiver. The central control unit includes a graphical interface for viewing the position of the radio signal sources.

Abstract: The invention relates to a device for electrophysiologically localising target areas in the brain, comprising a multi-channel microprobe (10) which at its active end comprises a multitude of tightly packed microelectrodes arranged axially in rows, via which electrophysiological efferences are obtained in the target area and forwarded to an evaluating unit, wherein the microprobe (10) is assigned to a tracking device (5) which allows the microprobe (10) to be positionally detected by means of a neuronavigation system (1, 2, 3, 8) and the insertion of the probe to be stereotactically planned.

Abstract: Surgical implements used during an operating procedure are detected in human tissue. Markers attached to the surgical implements change their impedance at a preselected frequency in the presence of an electromagnetic field. Each of the markers is thereby provided with signal-identifying characteristics. The signal-identifying characteristics are detected outside the operating room in an accurate, reliable manner. Potential interference with operating room electronic instrumentation is avoided, the possibility of operator error is reduced and system cost and space requirements are substantially lowered.

Abstract: An integrated surgical anchor/localization sensor is disclosed. The anchor is adapted to be secured to an anatomical structure and contains a sensor housing. A receiver is located within the sensor housing and is adapted to sense reference signals generated by a surgical guidance system. A transmitter, connected to the receiver, conveys to a processor signals received by the receiver, so that the signals transmitted by the receiver are indicative of a current position of the anchor. Various other structures and methods are also disclosed.

Abstract: A food intake restriction apparatus and method includes and uses an operable restriction device implanted in a patient and engaging the stomach or esophagus to form a restricted stoma opening in the stomach or esophagus. A source of energy for energizing the restriction device, and a control device for releasing energy from the source of energy from outside the patient's body are provided. The released energy is used in connection with the operation of the restriction device to vary the size of the stoma opening to allow or substantially prevent the passage of food therethrough.

Abstract: An apparatus, system, method and computer program product for monitoring and controlling bio-enhancement implants is provided. With the apparatus, system, method and computer program product, a user may control the operation of implantable devices within the user's body by operation of a personal digital device. The personal digital device may obtain operational settings of the various implantable devices based on information stored within the personal digital device and/or information obtained from a network. The settings of the various implants are established in view of the possible interactions of the implants with one another. The personal digital device further monitors the operation of the implantable devices and the user's biological indicia. Based on the monitoring, the operation of the implantable devices are modified to obtain a desired result.

Abstract: Apparatus and methods are provided for the delivery of molecules to a site via a carrier fluid. The apparatus include microchip devices which have reservoirs containing the molecules for release. The apparatus and methods provide for active or passive controlled release of the molecules. Embodiments include systems for release of fragrance molecules and beverage additives.

Abstract: A plurality of co-operative and complementary software programs are implemented in a web-enabled high speed computer system to remotely monitor, manage and modify the operational and functional parameters of a plurality of implanted medical devices (IMDs). The system utilizes virtual electrophysiologist module (VEM), chronic monitoring module (CMM) and prescription program module (PPM) programs to effect specific therapeutic and diagnostic methods for managing the IMDs, remotely on a conditions and real-time basis. The modules enable remote and continuous monitoring, management and maintenance of the IMDs by identifying critical medical events, determining optimal clinical settings and upgrading performance parameters based on prescriptive data. The modules are implemented in a data center having high-speed computers operating in a web-enabled environment. The modules and the IMDs communicate through wireless communications system via a programmer or an interface medical unit (IMD).

Abstract: A guide for controlling the orientation of a medical device includes a cannula having a lumen therein for the medical device, and a guide member having a passage therein for receiving and directing the medical device, the guide member being movably mounted in the cannula for movement. The guide member can be magnetically responsive to an externally applied magnetic field, or can be magnetically responsive to an externally applied magnetic field when a magnetic medical device is in the passage, and/or it can be mechanically responsive.

Abstract: A method for measuring temperature and of adjusting for temperature sensitivity of a medical device having a position sensor comprises the steps of providing a medical device having a position sensor and measuring voltage at the position sensor. A resistance value is then determined from the measured voltage and a temperature value at the position sensor is determined based on the resistance value. The temperature value is determined using the position sensor. Accordingly, temperature is directly measured and monitored using the position sensor itself. Additionally, a sensitivity is determined at the position sensor based on the temperature. Location information from the position sensor is adjusted based on the sensitivity.

Abstract: A percutaneous or transcutaneous connecting device, featuring at least one passage or a passage-free connection through the outer surface and in particular the skin of a living being, incorporates a permanent magnet (7) which is positioned in the area of the outer surface such as the skin (1, 3) with its poles essentially extending parallel thereto. In the case of a percutaneous connecting device, physical passages (9) are provided which extend through the outer surface of the living being, whereas in the case of a transcutaneous connecting device the transfer of electrical or electromagnetic signals and/or electrical energy takes place without physical passages, instead employing for instance coils.

Abstract: A medical device and position sensor combination for use in medical applications comprises a position sensor having a core made of a high permeable material. The core material is made of a Wiegand effect material comprising a mixture of cobalt, vanadium, and iron. The position sensor has an outer diameter of approximately 0.4 mm and is used in a medical device having an outer diameter of approximately 0.67 mm.

Abstract: A method of navigating a magnet-tipped distal end of an elongate medical device through the body includes providing an image display of the part of the body through which the medical device is being navigated and using the display to input the desired path of the medical device by identifying points on the desired path on the display. The magnetic field needed to orient the end of the medical device in the direction of the desired path as indicated on the display is then determined. In one embodiment where only points on the desired path are identified, the field direction is the direction indicated by the points on the desired path.

Abstract: Methods and apparatus are provided for locating the position, preferably in three dimensions, of a sensor by generating magnetic fields which are detected at the sensor. The magnetic fields are generated from a plurality of locations and, in one embodiment of the invention, enable both the orientation and location of a single coil sensor to be determined. The present invention thus finds application in many areas where the use of prior art sensors comprising two or more mutually perpendicular coils is inappropriate.

Abstract: Systems and methods for locating an operative element within an interior body space use a locating probe, which includes at least one transmitting element to transmit an electric waveform output within at least a portion of the space. The systems and methods also use a sensing element, which is adapted to be carried by the operative element to sense a local electric waveform within the space. A processing element coupled to the sensing element generates a processed output that locates the sensing element relative to the locating probe based, at least in part, upon a differential comparison of the waveform output and the sensed local waveform.

Abstract: The present invention provides an implantable substrate sensor comprising electronic circuitry formed within, or on, a substrate. A protective coating then covers the substrate, forming a hermetically sealed package having the circuitry under the coating. The circuitry has electrically conductive pads for communicating and/or providing power to the circuitry. Electrical pathways provide hermetic electrical connection to the conductive pads for external connection to the sealed circuitry. In a first embodiment, the pathway is a via that is made from a biocompatible material that is made hermetic by either increasing its thickness or by ion beam deposition.

Abstract: Methods and apparatus are provided for locating the position, preferably in three dimensions, of a sensor by generating magnetic fields which are detected at the sensor. The magnetic fields are generated from a plurality of locations and, in one embodiment of the invention, enable both the orientation and location of a single coils sensor to be determined. The present invention thus finds application in many areas where the use of prior art sensors comprising two or more mutually perpendicular coils is inappropriate.

Abstract: A magnetic field position and orientation measurement system contains, confines and re-directs the magnetic field from one or more transmitters such that the fields are attenuated in areas outside of the operating volume in areas where metallic objects are commonly found. An attenuator made of a highly permeable material such as ferrite or mumetal may be placed on top of a conductive plate. The permeable attenuator may be as thin as 0.001 inches. On top of the permeable attenuator, a transmitter system is placed including at least three transmitters. In one embodiment, the transmitter consists of a PC board carrying the transmitter. The transmitter system, the permeable attenuator and the conductive plate, where used, may only be from 1/2 inch to 5/8 of an inch in thickness combined. The permeable attenuator may have a flat, planar configuration. Alternatively, it may be made to resemble, in cross-section, a cake pan having a flat central region with uplifted peripheral edges.

Abstract: An electrophysiology catheter includes a tube having a proximal end, a distal end, and a lumen therebetween. The tube is preferably comprised of multiple sections of different flexibility, arranged so that the flexibility of the catheter increases from the proximal end to the distal end. There is a first generally hollow electrode member at the distal end. A magnetically responsive element is disposed at least partially in the hollow electrode, for aligning the distal end of the catheter with an externally applied magnetic field. The end electrode can have openings for delivering irrigating fluid, and/or a sleeve can be provided around the tube to create an annular space for the delivering of irrigating fluid. A temperature sensor can be provided to control the operation of the catheter. A localization coil can also be to sense the position and orientation of the catheter.

Abstract: An apparatus and method for locating a magnetic implant in a surgical application using the field of a source magnet for the implant guiding field. The source magnet is an electromagnet having a separate calibrated magnetic field component in addition to the guiding field, so that both the magnitude and orientation of the magnetic field as a function of position around the magnet are known. A magnetic implant is provided with a sensor, such as a three-axis Hall effect sensor, to provide an indication of the magnitude and orientation of an applied magnetic field when the implant is surgically implanted in a patient. After implantation, the source magnet is energized with a current having a modulated component.