Abstract: An in-series ventricular assist system for assisting the circulation of blood in a patient is disclosed. A pumping bladder is disposed in the thoractic aorta of the patient and selected physiologic events relating to each heart beat are monitored by appropriate sensors. A gas handling subsystem inflates and deflates the pumping bladder in accordance with the detected physiologic events and a predetermined set of assist system parameters. A microprocessor evaluates the effects of inflation and deflation of the pumping bladder and the corresponding assistance on the patient for each heart beat. The microprocessor is operable to alter or adjust the assist system parameters for each subsequent heart beat in accordance with the effects of assistance of the pumping bladder on the patient.

Abstract: A surgical tool for forming a circular opening through the skin which is of smaller diameter at the outer skin surface than at the inner surface of the skin employs a trephine having a circular cutting edge. The trephine is inserted into a pocket surgically formed beneath the skin with its cutting surface facing the skin. A rod member is then inserted through the skin and threaded into the trephine. The rod member is attached to a spring biassed plunger within a tool housing which is released from a ready position by withdrawal of a locking pin. Upon release of the plunger, the spring drives the plunger to drive the cutting edge of the trephine outwardly through the skin.

Abstract: A culture and transport assembly for enclosing a percutaneous access device within a sealed outer container to maintain the device under sterile conditions during transport while accommodating culturing of a coating of dermal cells on a portion of the device while the device is retained within the container. The container has a removable cap to which a culture well body is attached. The percutaneous access device is releasably clamped between the bottom of the body and an underlying platform with a portion of the device projecting into a bore in the body. When the device is so clamped, the bore constituted a sealed culture chamber in which the dermal cell culturing procedure may be performed by introducing cells and culturing solutions into the chamber via fluid passages extending from the chamber to connectors accessible at the exterior of the cap.

Abstract: A combination is provided of a percutaneous lead designed for implantation in the human body, which lead has a surface which is adapted to pass through and be exposed to the dermis of a patient when the device is implanted. Said surface is adapted to receive the growth of a cultured autogenous fibroblast coating on an etched, nanoporous surface. A liquid tight sealed removable, disposable chamber encloses said surface, said chamber being provided with openings for introduction therein of finely divided living dermal tissue suspended in a liquid carrier, thus providing a means for formation of the cultured surfaces which can be easily handled. The disposable chamber is removed and discarded at the time of surgery.

Abstract: A pair of spaced electrodes are disposed inside the thoracic aorta near the heart and are used to sense R- and P-waves in an ECG signal. The electrodes are moved to an ideal intra-aortic position, which is that where R- and P-waves are sensed to have the same magnitude, the P-wave, which occurs earlier than the R-wave, serving as means for accurately predicting the occurrence of the R-wave. The electrodes are affixed to the distal end of an intra-aortic balloon, which is capable of being disposed at the ideal position by monitoring of the R- and P-waves sensed by the electrodes. The balloon is deflated at the occurrence of the R-wave, which has been correctly predicted by the earlier P-wave.

Abstract: An intra-aortic balloon pump apparatus includes a first catheter one end of which is secured to a connector having a gas supply port, a balloon one end of which is secured to the distal end of the first catheter, a central tubular member the distal end of which projects from the distal end of the first catheter and to which the distal end of the balloon is fixedly secured, a second catheter freely insertable into the central tubular member and having a distal end provided with an arterial pressure transduceer, and a second connector to which the other end of the second catheter is secured for feeding a signal from the pressure transducer to the outside of the apparatus. After the balloon, central tubular member and first catheter are placed into the aorta, the second catheter having the pressure transducer at its distal end is inserted through the interior of the central tubular member into the aorta.

Abstract: An apparatus and method for placing an aortic balloon catheter is provided wherein a pair of spaced electrodes on the distal end of the catheter assembly are disposed inside a thoracic aorta near a patient's heart and are used to sense R-waves and P-waves in an ECG signal. The electrodes are moved to an ideal intra-aortic position where the R-waves and P-waves are sensed to have the same magnitude. The P-wave, occurring earlier than the R-wave, serves to accurately predict theoccurrence of the R-wave. The balloon of the catheter is deflated upon sensing the R-wave.

Abstract: A percutaneous access device (PAD) is provided with a sleeve or separable member which may be detached from the device to enable the culturing of a multilayer fibroblast coating on the member in a stable and undisturbed environment. The member is constructed so that when it is assembled into the device and the device is implanted in a patient, the cultured coating of the member is exposed to the patient's dermis whose fibroblasts will, after a relatively short healing period, merge with the fibroblasts of the coating to form a barrier layer interlocked with the member to prevent epidermal ingrowth or marsupialization of the implanted device.Implantation techniques for further facilitating the formation of the dermal barrier are also disclosed.

Abstract: An improved dynamic aortic patch is constructed with an elongate semi-rigid shell member having a concave inner surface and a flexible membrane integrally bonded to the outer surface of the shell to define an inflatable and deflatable chamber between the concave inner surface and the membrane. The pumping capacity of the patch is determined by the concavity of the inner surface of the shell member, thus enabling the construction of a patch which may be implanted in the thoracic cavity (small concavity) or in the abdomen (large concavity). A fabric layer bonded to the membrane over the area overlying the outer surface of the shell has a peripheral suture flange projecting freely clear of the membrane, and a temporary shield adapted to overlie the fabric layer may be employed to assure that sutures placed to attach the patch within an opening in the aorta are not inadvertently passed through the membrane.

Abstract: A prosthetic myocardium is disclosed for replacing necrotic or scarred myocardial tissue to positively simulate both myocardial contraction and expansion during systole and diastole. The prosthetic device includes several circumferentially arranged tilting arms which are sutured to the periphery of an opening in the heart formed by a medical excision. The tilting arms are pivotally supported and functionally interconnected with an axially reciprocal drive rod which effects synchronized inward and outward pivoting of the tilting arms to simulate the myocardial functions during heartbeat.

Abstract: An improved dynamic aortic patch is surgically implanted in the thoracic aorta and is systematically inflated and deflated to generate pressure waves in the bloodstream. The pressure waves assist the heart by augmenting the circulation of the blood through the body. The patch includes a flexible inflatable bladder and an independent envelope. The envelope has a reinforced surface for limiting and directing inflation of the bladder inwardly toward the lumen of the aorta.

Abstract: An improved connector having mating connector members with at least two paths in each connector member. Magnets are positioned in each connector to generate spatially oriented magnetic fields; the fields for one connector member being complementary to those of the other connector member. As the connector members are moved toward each other, the complementary fields align the members and maintain a releasable connection therebetween with the paths in each connector member properly aligned. The complementary magnetic fields preclude misalignment and provide quick release of the connector members when a sufficiently strong external force is applied.