Abstract: A medical device for endoscopic access of a body cavity and a method of percutaneously placing inner and outer access sheaths of the device into the body cavity. The medical device includes inner and outer access sheaths and a dilator which is inserted into the outer sheath and has a shoulder or a shoulder piece for abutting against the proximal end of the outer sheath. The device also includes a wire guide that is percutaneously inserted into the body cavity via an introducer needle. The dilator and outer sheath are placed over the wire guide to dilate the puncture site and introduce the dilator and outer sheath into the body cavity. The dilator comprises an elongated cylindrical member having a passageway opening distally from the conically-shaped distal end and from an outside lateral wall of the dilator about the proximal end. The dilator also includes an end cap which is utilized to force the dilator and the outer sheath through the puncture site and into the body cavity.

Abstract: A dual lumen catheter is disclosed for providing extracorporeal treatment such as hemodialysis, which is percutaneously inserted for either short-term or long-term vascular access. The catheter includes a main body having proximal and distal segments connected to a pair of clamping limbs via a manifold. The distal segment includes two tubular members laterally attached to each other, one of which is thinner than the other and collapsible for inserting the catheter through a much smaller diameter peel-away sheath. Contrary to existing practices, the lengths of the arterial and venous tubular members are reversed such as to provide a longer negative pressure intake lumen. A hydrophilic slip coating covers the distal segment to further ease the insertion of the distal segment into the peel-away sheath. The cross-sectional area of the proximal segment is generally elliptical shaped for providing a leak proof fit through the vascular access site.

Abstract: A catheter for intubating a stoma formed by a percutaneous endoscopic technique includes a multi-lumen tube and an inflatable cuff for retaining the catheter in place. The tube includes a fluid lumen for conveying fluid into a patient and an inflation lumen having a port in communication with the interior of the cuff to allow for the egress and ingress of fluid to the cuff. The cuff has contained therein a resilient sponge-like material which has the property that it will remain in its compressed state for an ascertainable period of time after having been maintained in the compressed state for a predetermined period of time, e.g., at least 24 hours. A period of time, not less than the predetermined period of time, prior to the intubation procedure, the cuff is compressed to expel air from the cuff through the inflation lumen and to compress the sponge-like material inside the cuff. A tubular sleeve is applied to the outside of the cuff to maintain the cuff and sponge-like material in its collapsed state.

Abstract: An ablation catheter is provided with an elongated member or shaft and a plurality of helically-shaped cutting wires attached to the shaft to form a cutting basket. Each of the cutting wires has a section formed as a circumferentially subscribing arc and together the wires present a circumferential cutting area of an essentially cylindrical configuration. Obstructing matter on the inner surface of a vessel cavity, such as a blood vessel or the like, is separated from the surface as the catheter is moved through the vessel. The catheter may be inserted in a vessel in a standard fashion using a wire guide which extends through a longitudinal passageway in the shaft and a hub interconnecting the basket wire. The shaft and basket together may be contained in an outer sheath to facilitate insertion.

Abstract: Echogenic medical devices and methods of fabrication and of use are disclosed. The devices are adapted to be inserted into a patient. The device includes an elongated member including a material having an acoustic impedance different from that of the surrounding medium. The medium includes surrounding biological tissue or fluids surrounding the member when inserted into a passageway of the patient. The acoustic impedance of the elongated member is sufficiently different from the surrounding medium for enhancing an image produced in response to a sonic beam produced from imaging equipment. The elongated member also includes an interface including the outside surface of the member and a plurality of partially spherical indentations therein. Alternatively, generally spherical particles are attached to the surface of the member for producing the image in response to the sonic beam. Materials such as stainless steel, plastic, and glass are utilized in the manufacture of the medical device.

Abstract: An exercise-responsive cardiac pacemaker is provided which physiologically controls the stimulation rate of a heart by sensing the venous blood temperature in the right ventricle of the heart. A temperature sensing means which includes a thermistor produces an output signal which is sent to an algorithm implementing means for implementing the output signal by an algorithm which represents the mathematical function between venous blood temperature in the right ventricle and heart rate in a normally functioning heart. The algorithm implementing means produces an output signal which is variable between a maximum and minimum level corresponding to the desired maximum and minimum levels of heart rate in a normally functioning heart. The algorithm implementing means is also programmable by telemetry after implantation. A cardiac pacemaker is connected to the algorithm implementing means and is responsive thereto in order to variably control the stimulation rate of the heart.

Abstract: An extremely small diameter epidural catheter is disclosed which is both flexible and kink-resistant when flexed. The catheter includes a tubular sheath or tube having a passageway therein for the delivery of fluids to biological tissue. Positioned in the passageway is a coil which is expansion-fitted therein to form a composite wall structure which is extremely flexible and kink-resistant. This composite wall structure is utilized to form a catheter having an extremely small outside diameter in a range of 0.010" to 0.032" for delivering acceptable levels of fluid volume. The coil comprises a plurality of closely spaced turns extending from the proximal to almost the distal end thereof. About the distal end of the coil is a number of loosely coupled or relaxed turns which adds further flexibility to the distal end of the catheter. The tubular sheath of the catheter comprises a high tensile or flexural strength material which does not rupture or tear when the catheter is bent or flexed.

Abstract: A stone retrieval basket having superelastic metallic alloy wires attached to the distal end of an inner elongaged member tube for retrieving calculi and crushing them against an outer introducer tube percutaneously inserted into a patient. The basket comprises kink-resistant superelastic metallic alloy wires such as nitinol forming a bulbous shape for capturing calculi therein. The ends of the superelastic wires of the basket are attached to the distal end of a inner elongated member tube with the aid of sleeves crimped thereon, which are soldered or spot welded in recesses about the distal end of the inner tube. The outer tube is percutaneously inserted into the biliary or urinary system in which the basket is then inserted to capture large-sized stones. A peel-away sheath is also included to introduce the basket and inner elongatged member tube into the outer introducer tube.

Abstract: A medical retrieval basket having superelastic metallic alloy wires attached to the distal end of an inner elongated member tube for percutaneously capturing and removing calculi from a cavity or duct of a patient. The basket comprises kink-resistant superelastic metallic alloy wires such as nitinol which forms a bulbous shape for capturing calculi therein. The ends of the superelastic wires of the basket extend through the passageway of the inner elongated member tube and are attached to the proximal end of the tube. An outer elongated member tube is percutaneously inserted into the biliary or urinary system. The inner member tube is inserted through the outer member tube into a duct, cavity or organ of the patient. The distal ends of both the inner and outer member tubes have a predetermined longitudinal curvature for controlling the positioning of the basket and the tubes within the patient.

Abstract: A suture guide and, in particular, a urethral sound having interchangeable tips for placing sutures in the severed end of a body duct. The urethral sound includes an attachment mechanism having interconnection parts longitudinally rotatable when interconnected. The sound further includes an elongated member having a distal end portion including one of the interconnection parts. A plurality of interchangeable tips are provided each having a rounded distal end and a proximal end including the second interconnection part. Interchangeable tips are positioned at the distal portion of the elongated member and are longitudinally rotated thereat. Various tips include one or more apertures for placing sutures through, for example, a severed urethral stump created during a radical prostatectomy. Channels are also placed in a number of the tips to provide placement of individual sutures about the distal end of the severed stump as desired by the physician.

Abstract: Method and apparatus are disclosed for replacing an endotracheal tube. The apparatus comprises an endotracheal tube obturator having an air passageway therein and a removable connector positioned at the proximal end of the obturator tube for ventilating the patient during replacement of the endotracheal tube. The obturator tube also includes a plurality of side ports for further ventilating the patient should mucous block the distal end of the obturator tube passageway. The removable connector includes a ventilator fitting and a removable and lockable obturator tube fitting joined thereto. The obturator tube fitting includes a sleeve having a plurality of flexible members for grasping the proximal end of the obturator tube. Extending into the passageway of the sleeve is a projection from the members for engaging the outside surface of the obturator tube when inserted in the passageway.

Abstract: An implantable container for housing a cardiovascular treatment device is disclosed with a window positioned in an external wall thereof for sensing a physiological parameter for the treatment device. The window is formed of an insulating material such as glass, a semiconductor material, or a membrane for sensing any one of a plurality of various physiological parameters. In one embodiment, the window material is glass on which a pair of electroptic devices are positioned on the interior surface thereof for emitting and receiving optical signals for sensing the physiological parameter. In another embodiment, the window comprises glass with a plurality of electrodes externally positioned thereon for measuring, for example, the electrical properties of the physiological parameter.

Abstract: A lockable sleeve drainage catheter is disclosed for percutaneous insertion into a patient and drainage of fluid therefrom. The drainage catheter includes a flexible distal end that is preformed for retaining the distal end of the catheter that is inserted in the patient. For insertion, the distal end is straightened with the use of a stiffening cannula that is inserted through the hollow passageway of the catheter. When the catheter is inserted in the patient, the stiffening cannula is removed, and a flexible tension member positioned within the passageway of the catheter is drawn to position the distal end in the desired retention configuration. A lockable sleeve positioned at the proximal end of the catheter draws the flexible tension member through the passageway of the elongated member tube to position the distal end in the retention configuration. The catheter also includes a locking collar at the proximal end of the elongated member tube having an annular recess formed therein.

Abstract: A surgical tissue bag for percutaneously debulking large volumes of tissue contained within the bag. The tissue bag comprises two layers of material, an inner layer of a puncture-resistant material and an outer layer of moisture-proof material for containing cells and fluid therein. The bag material is foldable and flexible for insertion through an access sheath into the surgical site and for forming a gas-tight seal when extended through the access sheath or puncture site. A drawstring is attached to the open end of the bag to close the bag when the tissue is contained therein and pulled through the puncture site in the outer surface of the skin. After the closed open end of the bag is pulled through the puncture site, the closed end is fanned out against the outer layer of the skin, and a morcellator is inserted into the bag for debulking the large volume of tissue. The open end of the bag is continually fanned out to maintain a compact and tight containment of the tissue and fluid remaining in the bag.

Abstract: A needle driver instrument suitable for use with a trocar sheath in operative endoscopic surgical procedures such as laparoscopic and pelviscopic procedures is disclosed for driving a curved suture needle. The needle driver instrument comprises an elongated cylindrical tube member having a channel formed about the distal end thereof for receiving either a curved or a straight suture needle. The channel is transversely formed through the elongated member and has a plurality of surfaces to orient and fix the suture needle in a predetermined orientation. A wedge operable across the channel and through the passageway of the elongated member wedges the needle between at least two of the contact surfaces of the channel to fixedly position the suture needle in the desired orientation. At the proximal end of the device is a handle with a generally U-shaped spring extending therefrom for manual operation of the wedge.

Abstract: Heart lead removal apparatus and method are disclosed for removing a pacemaker lead from a heart through a blood vessel leading thereto. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the pacemaker lead. A lockable mechanism grasps the proximal end of the lead, and a wire guide is inserted in the passageway of the lead to determine its size and clear any blockage therein. The stylet wire is inserted in the longitudinal passageway of the coiled structure to the distal end of the pacemaker lead. The stylet wire is rotated in a direction to unwind and expand the wire coil and engage the coiled structure, thereby securing the stylet wire to the pacemaker lead. A tie secures the insulating material to the coiled structure of the lead at the proximal end thereof to limit motion and to apply a uniform extraction force to the entire lead.

Abstract: Heart lead removal apparatus and method are disclosed for removing a heart lead from the wall of a heart through a blood vessel leading to the heart. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the heart lead. A lockable mechanism grasps the proximal end of the lead, and a wire guide is inserted in the passageway of the lead to determine its size and any blockage therein. The stylet wire is inserted in the longitudinal passageway of the coiled structure to the distal end of the heart lead where the tip is typically secured to the heart wall with a number of tines formed from the insulating material surrounding the coiled structure. A tie secures the insulating material to the coiled structure of the lead at the proximal end thereof to limit motion and apply uniform extraction force to the entire lead.

Abstract: A temperature-based, rate-modulated cardiac pacemaker having means for variably controlling the stimulation rate of the heart according to multiple temperature characteristics of the blood referenced to multiple moving baseline temperatures. A target rate is periodically calculated by obtaining a weighted sum of the following rate components: (1) the magnitude of a decrease in temperature below resting temperature, a first moving baseline, (2) the magnitude of an increase in temperature above a local minimum temperature, a second moving baseline, (3) the magnitude of an increase in the resting baseline above a daily minimum temperature, a third moving baseline, and (4) the absolute value of the rate of change of temperature. The resting temperature is preferably calculated over a longer interval than the local minimum temperature but a much shorter interval than the daily minimum temperature.

Abstract: Method, apparatus, and a substance is disclosed for releasing at a temperature above normal tissue temperature an anti-cancer drug and applying heat in combination to tissue having neoplastic cells such as a malignant brain tumor. The apparatus comprises a probe having a semi-rigid elongated member that is interstitially implanted in the malignant tumor. The elongated member is coated with a carrier substance that is responsive at a temperature above normal tissue temperature for releasing a carried substance such as a therapeutic anti-cancer drug. Within the elongated member, an electrical heater element produces heat when energized for heating the probe, the carrier substance, the anti-cancer drug, and the surrounding tissue. An electrical thermistor is also included within the elongated member for measuring the temperature of the probe in order to regulate the release of the drug and the temperature of the surrounding tissue.

Abstract: Heart lead removal apparatus is disclosed for removing a heart lead from the wall of a heart through a blood vessel leading to the heart. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the heart lead. The stylet wire is inserted in the longitudinal passageway of the coiled structure to the distal end of the heart lead where the tip is typically secured to the heart wall with a number of tines formed from the insulating material surrounding the coiled structure. When inserted, the stylet wire is rotated in a direction to unwind and expand the wire coil and engage the heart lead coiled structure, thereby securing the stylet wire to the heart lead. A separator tube is inserted over the proximal end of the stylet wire and the heart lead and moved along the entire length of the heart lead to first separate the restricted heart lead from the blood vessel leading to the heart cavity.