Abstract: A guidewire is positioned within the coronary venous system and a pacemaker implantation catheter is arranged and configured to track the guidewire without substantially altering the position of the guidewire. A balloon catheter is deployed to temporarily and selectively secure the balloon catheter within the coronary venous system. The balloon temporarily and selectively secures or wedges the guidewire and the balloon catheter within the coronary venous system. The anchored guidewire is free along its proximal length to serve as a guide for a pacemaker lead implantation catheter. In the illustrated embodiment the movable coupling of the guidewire and catheter comprises a distally located low friction slideable coupling. The invention also includes methods for using and deploying the above apparatus in the coronary venous system.

Abstract: An introducer and hemostatic valve for improved torsional guidance and kink resistance includes an entirely circumferentially reinforced introducer connected directly to a valve body formed of a plurality of separable portions and housing a valve element in a central chamber thereof. The plurality of portions may be attached to the introducer during formation of the introducer, the valve body, or both. Alternatively, the plurality of portions may be attached to the introducer by assembly of the portions together in a surrounding relation to the introducer. In use, the plurality of portions are separated from each other and the introducer is cut along its length in order to withdraw the introducer and hemostatic valve over an enlarged proximal end of an access device as the introducer is pulled from the patient's body.

Abstract: A conductive guidewire having at least an exposed distal tip is endovascularly steered into an epicardial surface of a heart via the venous tributaries of the coronary sinus. A selected site is contacted by the tip of the guidewire and tested by means of the guidewire to determine suitability for permanent lead implantation. Implantation of the lead at the contacted site is contingent on the determination of the adequacy of all electrophysiological parameters. Testing includes the steps of determining the amplitude and slew rate of the local electrogram, generating an electrical stimulus, communicating the stimulus to the contacted site by means of the guidewire, sensing an electrophysiological response to the stimulus through the guidewire and determining that the pacing threshold parameters are appropriate. A permanent pacing lead is then chosen and guided by means of the guidewire to the contacted site and implanted.

Abstract: An adapter for an introducer comprises a medical device having a tubular port on a proximal end such as a splittable hemostatic valve. A tubular fitting is provided on a proximal end of the introducer. An elastomeric member is disposed between the port of the medical device and the tubular fitting of the introducer for providing a fluid tight and mechanically secure connection therebetween. The introducer and valve are manually connectable and reconnectable with each other while maintaining the fluid tight connection between them. A side port may communicate with the hemostatic valve, the side port having a controllable valve ending. In the preferred embodiment the introducer comprises a splittable introducer. In the illustrated embodiment the elastomeric member provides a slip fit between the medical device and the tubular fitting of the introducer. A tab extends from the tubular fitting of the introducer to facilitate manual manipulation of the tubular fitting.

Abstract: An introducer system for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus is comprised of a flexible, elongate, outer elongate element having a first shape or bias along a portion. The first shape on the outer element may be prebiased or may be initially straight and subsequently biased once deployed in the body chamber. A flexible, elongate, telescopic inner elongate element has a second shape or bias on its distal portion and has the first shape or bias on a more proximal portion. The inner elongate element is telescopically disposed in the outer sheath.

Abstract: The invention is defined as a precurved coronary sinus guiding introducer for use in a cardiomyopathic heart comprising a flexible elongated member with a proximal and distal end. The elongated member comprises a generally straight, proximal portion and a precurved distal portion. In one embodiment the proximal portion and distal portion are formed to lie is a common plane. In another embodiment the portions are angulated with respect to each other in different planes. The precurved distal portion comprises at least one curved subportion and at least one curved or straight subportion. The precurved distal subportion curves through a generally circular arc away and is defined by a chord of predetermined length. The precurved distal subportion has a predetermined height above the chord. The curved or straight subportion is the distal section of the precurved distal portion.

Abstract: An introducer system is used for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus. The system is comprised of three telescopic components, an inner telescoping core, a precurved inner telescoping sheath, and an outer telescoping sheath, introducer, guide or catheter. In an embodiment where a core is used it is torsionally stiff. In an embodiment where no core is used, the inner sheath is torsionally stiff. In either case, the member which is torsionally stiff is torqueable. In general, the inner sheath and outer guide will be both laterally and torsionally flexible, while the core will be torsionally stiff. The core and inner sheath, when curved together in the venous system and proximally coupled, will be sufficiently bound to each other that proximal rotation of the core will be coupled to and cause distal rotation of the inner sheath.

Abstract: The present invention is an apparatus for simultaneously transmitting biomedical signals and human voice over a telephone. The invention is also a telephone line adapted to receive communication from the receiving unit at a second end of the line while simultaneously transmitting biomedical signals and human voice from the first end. The apparatus comprises a sensor, a cable, and a transmitter device. The sensor comprises electrodes attached to a pad with a wire connected to each electrode. The cable groups the wires into a single unit and leads them to the transmitter device. The transmitter device comprises a converter and a acoustic. In operation, the sensor takes biomedical signals in the form of electronic data. The data is conveyed via the wires where it reaches the converter. The converter converts the biomedical electronic data into acoustic signal which is emitted by the acoustic in circuit with the converter. The acoustic signals are translatable back to biomedical signals by the receiving unit.

Abstract: A universal pressure pad for femoral clamps capable of coupling with two or more clamps of different design is provided by a generally disc-shaped pad with a central joint or boss which has a cavity with an upper spherical ball socket and a lower conical socket. Therefore, an insertion element from a clamp having a ball socket snaps into the upper ball socket cavity to form a swiveling ball and socket combination. Similarly, an insertion element from an artery clamp which has a rigid conical pin is disposed through the spherical ball socket in the upper portion of the joint and extends into the lower frustoconical section of the cavity to provide a force fit with the pin.

Abstract: An permanent indwelling catheter is provided with a selectively inflatable exterior balloon valve to to seal one or more orifices defined in the catheter wall or tip. The longitudinal lumen may either comprise a single central axial lumen or a plurality of subdivided lumens within the catheter body. The orifices may be defined through the side wall of the catheter at variable points along its length and/or may be defined in the tip of the catheter. In embodiment, the expansible membrane is disposed in the proximity of a distal tip orifice and is inflated to completely fill the space of the tip and extend into the tip orifice to seal it. In yet another embodiment, the membrane valve, is comprised of two or more separate membrane portions which are simultaneously inflated against each other and adjacent surfaces within the catheter to provide a sealing wall and means for sealing the orifice.

Abstract: Soft tissue injury in a recuperating patient who has an implanted object or guide tube in a femoral incision is avoided or substantially reduced by preventing or reducing hip flexure. Hip flexure is avoided or reduced by immobilizing the knee of the leg in which the femoral incision has been made. The knee is immobilized by a device which prevents flexure of the knee. The knee is further immobilized by positionally fixing the knee, thereby preventing medial, anterior and posterior movements. An orthopedic knee immobilizer is utilized to prevent knee flexure. The orthopedic knee immobilizer is connected to a strap which in turn is fixed to the bed or surface upon which the recuperating patient lies. In this manner, unconscious or involuntary movements made during sleep which might otherwise cause severe hematomas in the groin or near the femoral incision are substantially avoided.

Abstract: An improved femoral arterial or venous compressive device includes a flexible pelvic apron positioned over the femoral vessels within the human pelvis. The pelvic apron is placed in position by means of a hip strap. The hip straps are led from the pelvic apron upwardly over the hip points, around the small of the back and down over the opposing hip point back to the pelvic apron. The pelvic apron thus hangs from the hip points of the pelvis much like an apron. A shaped mass or pellet is attached to the under side of the pelvic apron over the incision site of the femoral vessel. An elastically extensible groin strap is then attached to the pelvic apron in the proximity of the shaped mass and drawn tighly through the groin, around the back of the leg, under the buttocks and back upwardly to the pelvic apron in the proximity of the shaped mass. As a result, the tensile force is applied by the groin strap across the pelvic apron up to the hip point and also around the leg.

Abstract: An improved femoral aterial or venous compressive device is comprised of a flexible pelvic apron positioned over the femoral vessels within the human pelvis. The pelvic apron is placed in position by means of a hip strap. The hip straps are led from the pelvic apron upwardly over the hip points, around the small of the back and down over the opposing hip point back to the pelvic apron. The pelvic apron thus hangs from the hip points of the pelvis much like an apron. A shaped mass or pellet is attached to the under side of the pelvic apron over the incision site of the femoral vessel. An elastically extensible groin strap is then attached to the pelvic apron in the proximity of the shaped mass and drawn tightly through the groin, around the back of the leg, under the buttocks and back upwardly to the pelvic apron in the proximity of the shaped mass. As a result, the tensile force is applied by the groin strap across the pelvic apron up to the hip point and also around the leg.