Abstract: A vascular or endoluminal stent adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein is formed from a metal open-ended tube which is the single component of the stent. The tube has a multiplicity of holes cut by laser through its wall. The through-holes are encompassed by serpentines that constitute the wall, the serpentines extending sinusoidally each in multiple 360° wavelengths in a single turn about the axis of the tube and juxtaposed in plural substantially identical segments disposed with regularity along the axis. Each segment has a length equal to the distance between crests and troughs of the sinusoid. Adjacent serpentines are joined together at crest and trough, respectively, so that their interconnections are 180° out of phase relative to their wavelength.

Abstract: A medical interventional device is structured for implantation in a human patient, to respond to detection of cardiac activity of the patient indicative of cardiac dysrhythmias. The device includes a cardiac therapy system responsive to a detected arrhythmia in either the atrial or ventricular chambers for automatic therapeutic treatment by selective application of an appropriate therapy regimen consisting of pacing, cardioverting or defibrillating waveforms of predetermined type and energy content to the chamber diagnosed as that in which the dysrhythmia originated. The device incorporates a DDD or DDD-R pacemaker for dual chamber sensing of electrical (ECG) activity, and for constant atrioventricular synchronization. A microprocessor-based logic subsystem is used for diagnosis of the origin of a rhythm disorder including identification of the originating heart chamber.

Abstract: A stent of high longitudinal flexibility includes multiple ring elements coupled together to be articulating without fixed physical attachment therebetween when the stent is in an unexpanded state, and to uncouple automatically while maintaining their positional relationship when the stent is deployed to an expanded state. The stent is fabricated to offer radial strength suitable for supporting a wall of a vessel, duct or tract of a patient in which the stent is to be implanted, against recoil of the wall in response to deployment of the stent. The fabrication process includes forming a plurality of common ring elements aligned along a longitudinal axis; and fashioning coupling elements on each of the ring elements to mate with and pivot longitudinally relative to coupling elements fashioned on neighboring ring elements without fixed physical attachment between the coupling elements.

Abstract: An implanted defibrillator provides a device-implemented method of delivering cardiac pacing, cardioversion and defibrillation therapies in selective response to dysrhythmia detection of an implant patient's cardiac signal. The patient's heart rate is sensed, and cardioversion/defibrillation therapies are delivered by the device by producing electrical shocks of adjustable energy level for application to the patient's heart in response to applicable detected levels of pathologic accelerated heart rate. A match between the generated cardiac pacing rate and the contemporaneous hemodynamic needs of the implant patient under conditions of rest and physical activity is optimized by sensing periods of patient physical activity and rest and generating a signal representative thereof to control the cardiac pacing rate accordingly and according to the extent of activity by means of an accelerometer mounted on hybrid electronic circuitry of the device.

Abstract: A method of forming an iridium oxide coating on a metal stent to achieve a firmattachment of a thin biocompatible coating of the iridium oxide such that the iridium oxide resists being dislodged from the stent upon expansion thereof in a vessel of the human body during implantation of the stent. The method includes submerging the stent in a coating solution having an adequate concentration of iridium chloride in a suitable liquid vehicle, and subjecting the coating solution with stent immersed therein to combined heating and application of ultrasonic energy at a temperature and energy level and for a time interval sufficient to form a coating of iridium oxide of desired thickness and surface roughness on the underlying metal surface of the stent.

Abstract: An unwanted effect of secondary radiation enhancement from backscatter of incident ionizing radiation on a relatively extensive metallic portion of an instrument to be inserted into a human body under x-ray fluoroscopy is minimized by coating the metallic surface thereof with a biocompatible material having the characteristic of shielding the secondary radiation enhancement effect from reaching body tissue. The depth of penetration of the secondary radiation enhancement is dependent on the atomic number of the metallic portion in conjunction with the expected radiation characteristics and energy level of the radiation incident on the metallic surface.

Abstract: A stent delivery system is sized to allow it to traverse small-sized vessels of diameter in a range from about 1.25 mm to less than about 2.5 mm in a human body. The delivery system includes a balloon which has an inflated diameter less than 2.5 mm at nominal pressure and is integrated distally on a catheter for selective inflation and deflation through a lumen of the catheter. The stent is adapted to be mounted on the uninflated balloon so that the combination of the balloon when uninflated and the stent mounted thereon has a crossing profile in a range from approximately 0.5 mm to approximately 0.8 mm, to enable the delivery system to rapidly traverse the small-sized vessel for subsequent deployment of the stent at a preselected target site of the vessel. At the target site, the balloon is inflated to expand the diameter of the stent to lodge against the wall of the vessel and remain in place when the balloon is deflated and the delivery system is withdrawn from the vessel.

Abstract: A method for external treatment of dysrhythmias including fibrillation of a patient's heart utilizes an externally located control box which generates electrical waveforms including shocks of variable energy content sufficient for terminating the dysrhythmias. A lead having transvenous defibrillation electrodes is inserted through a portion of the patient's venous system to position the electrodes to produce an electric field vector through the patient's heart when an electrical shock of sufficient energy content is applied across the electrodes. The control box is electrically connected to the lead to deliver electrical shocks from the control box to the electrodes, and to deliver a representation of the patient's ECG waveform to the control box. A display screen on the control box aids in synchronously triggering the electrical shocks in response to detection of the QRS complex of the ECG waveform.

Abstract: A non-radioactive metallic stent is coated with a biodegradable thin coating of less than about 100 microns in thickness selected to avoid provoking any foreign body reaction. The biodegradable material in the coating disintegrates over time in the presence of body fluid. The coating contains a radioactive source of, for example, a beta radiation emitter for irradiation of tissue when the stent is implanted in a blood vessel treated by angioplasty, to inhibit proliferation of smooth muscle cells in response to trauma to the wall of the blood vessel from the angioplasty, and thereby to prevent rapid tissue growth and consequent restenosis of the vessel. The stent coating incorporating the radioactive source constitutes a first layer adherent to and overlying the surface of the stent. The coating may further include a second layer atop the first layer, incorporating an anti-coagulant substance to inhibit thrombus formation on the stent.

Abstract: A vascular or endoluminal stent adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein is formed from a metal open-ended tube which is the single component of the stent. The tube has a multiplicity of holes cut by laser through its wall. The through-holes are encompassed by serpentines that constitute the wall, the serpentines extending sinusoidally each in multiple 360.degree. wavelengths in a single turn about the axis of the tube and juxtaposed in plural substantially identical segments disposed with regularity along the axis. Each segment has a length equal to the distance between crests and troughs of the sinusoid. Adjacent serpentines are joined together at crest and trough, respectively, so that their interconnections are 180.degree. out of phase relative to their wavelength.

Abstract: An implantable medical interventional device is adapted to provide therapy to a patient in whom the device is implanted to treat cardiac dysrhythmias including tachyarrhythmia. The device performs a plurality of functions corresponding to different levels of therapy for treatment of sensed dysrhythmias, including an electric shock waveform of predetermined energy content for delivery to the patient's heart to terminate at least one type of tachyarrhythmia. In response to cessation of the tachyarrhythmia after delivery of the electric shock waveform, the device promptly thereafter applies post-shock pacing pulses to the heart for a period of time sufficient to allow the heart to recover from the shock and to resume substantially normal sinus rhythm. The device may be upgraded by programming to select among the various functions as necessary to provide designated therapy by suppressing some functions and activating others.

Abstract: A vascular or endoluminal stent is adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein. The stent includes a biocompatible metal hollow tube constituting a base layer having a multiplicity of openings through an open-ended tubular wall thereof, the tube constituting a single member from which the entire stent is fabricated, and a thin, tightly adherent intermediate layer of noble metal overlying the entire exposed surface area of the tube including edges of the openings as well as exterior and interior surfaces and ends of the wall. A third, outermost ceramic-like layer composed of an oxide, hydroxide or nitrate of a noble metal is formed atop and in adherent relation to the intermediate layer.

Abstract: An implantable medical interventional device responds to detection of any of a plurality of cardiac dysrhythmias in a human patient by performing an appropriate therapy which may include cardiac pacing, cardioversion or defibrillation according to the nature of the detected dysrhythmia. A first sensor detects whether and what type of dysrhythmia is occurring. A generator produces pulses and/or shocks for delivery to the patient's heart according to whether a detected dysrhythmia is bradycardia or slow pathologic tachycardia on the one hand, or fast tachycardia or fibrillation on the other hand. An optimizer in the device at all times maintains a substantial match of the cardiac pacing rate to the hemodynamic needs of the implant patient under conditions of rest and physical activity; including sensing and distinguishing periods of patient physical activity and rest, and generating a signal representative thereof to control the cardiac pacing rate accordingly.

Abstract: An interventional medical device has a capability to sense cardiac dysrhythmias and to selectively respond with one among a hierarchy of therapies appropriate to terminate the sensed dysrhythmia and return the heart of the patient in whom the device is adapted to be implanted to normal sinus rhythm. The device includes a therapy generator having a housing and electronics for conducting bidirectional communication with the patient. The bidirectional communication is carried out by detecting the occurrence of a predetermined dysrhytlnia, such as atrial fibrillation, to alert the patient of such occurrence, and by responding to instructions from the patient following such alert for addressing the detected predetermined dysrhythmia. The detection is performed by electrodes mounted directly on the header of the device housing to both detect occurrence of the atrial fibrillation and for alerting the patient thereof by stimulating body tissue such as pectoral muscle in the vicinity of the header electrodes.

Abstract: A medical interventional device is structured for implantation in a human patient, to respond to detection of cardiac activity of the patient indicative of cardiac dysrhythmias. The device includes a cardiac therapy system responsive to a detected arrhythmia in either the atrial or ventricular chambers for automatic therapeutic treatment by selective application of an appropriate therapy regimen consisting of pacing, cardioverting or defibrillating waveforms of predetermined type and energy content to the chamber diagnosed as that in which the dysrhythmia originated. The device incorporates a DDD or DDD-R pacemaker for dual chamber sensing of electrical (ECG) activity, and for constant pacing of the atrium and atrioventricular synchronization. A fuzzy logic subsystem is used for diagnosis including identification of the originating heart chamber.

Abstract: An implantable cardiac pacemaker is adapted to be selectively non-invasively upgraded from time to time after implantation to provide a plurality of different diagnostic, functional, and pacing operational modes in the form of respective combinations of single and dual chamber sensing and pacing and rate-adaptive pacing of a patient's heart to correct any of various cardiac arrhythmias attributable to cardiac pacing or cardiovascular disorders, and of extended memory and physiological monitoring functions. The pacemaker is implemented to make available the plurality of different pacing operational and other functional modes, and is programmable to selectively enable current operation of at least one of the available pacing operational modes according to current needs of the patient while inhibiting current operation of all other available pacing operational modes and any other non-selected functional modes.

Abstract: A method of preventing or reducing the incidence of staphylococci and other infections as a result of surgical or medical treatment procedures is implemented by inserting into or attaching to each sterile package containing a tool, implement, or implantable for use in such a procedure at least one impregnable swab containing a solution of H.sub.2 O.sub.2 packaged in a separate sterile pack, for use by the surgeon, therapist, or assistant in wiping down the tool, implement, or implantable, as the case may be, before use to maintain the sterility thereof in such procedure. The solution of H.sub.2 O.sub.2 is in a concentration of about 3% by volume. A plurality of separate sterile packs may be inserted in or attached to the sterile package, in which each of the sterile packs contains at least one swab impregnated with a solution of H.sub.2 O.sub.2 in such concentration.

Abstract: A stent delivery system includes a catheter having a balloon mounted at its distal end for advancement into and withdrawal from a patient's vascular system by manipulation of the catheter from a point external to the patient's body, a lumen extending through the catheter into the balloon to allow the balloon to be selectively inflated and deflated from a pressurizing medium external to the patient's body, and spaced-apart radiopaque projections on the catheter adjacent the proximal and distal ends of the balloon to receive and retain a stent therebetween in overlying relation to the balloon and to provide x-ray markers thereof. The stent is deployed at a designated target site by selectively inflating the balloon to radially expand the diameter of the stent against the vascular wall.

Abstract: A method for treating a site in a human body to inhibit abnormal proliferation of tissue at the site includes introducing into the body at the site a metal surface which generally conforms in shape to the shape of tissue to be treated at the site. Tissue at the site is then irradiated with ionizing radiation directed onto the metal surface from a point external to the surface so as to obtain locally enhanced radiation therapy by an amplification of the radiation dosage delivered to tissue adjacent to the metal surface as a result of backscattered radiation from the metal surface. Irradiating the tissue is performed by directing a beam of radiation with an energy content selected to have a value in a range from about 10 KeV to about 400 KeV, preferably about 40 KeV, from a point external to the body toward the metal surface and onto the tissue to be treated.

Abstract: A vascular stent adapted to be implanted in a blood vessel of a human patient to enhance the flow of blood therethrough, includes an elongate biocompatible metal member of cylindrical shape and tubular sidewall with a pattern of multiple openings therethrough and open ends. The stent has an insertion outer diameter sufficiently small to enable it to be inserted into and advanced through a portion of the vascular system of the body to a preselected point within a coronary artery. The sidewall has a thin adherent coating of iridium oxide covering substantially its entire exposed surface, including the outward-facing surface between openings, the edges of the openings, the inward-facing surface between openings, and the edge of each of the open ends. The coating is of substantially uniform thickness throughout its coverage of the surface of the sidewall, and serves to reduce irritation of tissue of the inner lining of the vessel wall into which the outward-facing surface of the stent comes into contact.