Abstract: An implantable aortic blood pump includes a rigid body having wall extending along a long axis and defining an inflation port portion with an inflation aperture therethrough. The aperture is fluid communication with an inner surface of the body and on a fluid supply, the body is preferably independent of an external brace or an external stiffener, yet still has a cantilevered deformation of less than 8 millimeters in response to a 200 gram weight suspended from a front body edge. A deflecting structure of a membrane deflects in response to fluid pressure so as to pump blood when the pump is secured to a subject aorta.

Abstract: An aortic blood pump is described that is secured to a patient aorta that can be inflated and deflated in response to selective communication with a source of pressurized fluid or air. An expanded stent creates an area in with the pump and inflate and deflate. A system is also detailed including the pump and an external air line external to a patient body.

Abstract: An implantable aortic blood pump includes a rigid body having wall extending along a long axis and defining an inflation port portion with an inflation aperture therethrough. The aperture is fluid communication with an inner surface of the body and on a fluid supply, the body is preferably independent of an external brace or an external stiffener, yet still has a cantilevered deformation of less than 8 millimeters in response to a 200 gram weight suspended from a front body edge. A deflecting structure of a membrane deflects in response to fluid pressure so as to pump blood when the pump is secured to a subject aorta.

Abstract: An aortic blood pump is described that is secured to a patient aorta that can be inflated and deflated in response to selective communication with a source of pressurized fluid or air. An expanded stent creates an area in with the pump and inflate and deflate. A system is also detailed including the pump and an external air line external to a patient body.

Abstract: A pump has an elongated shell with a generally elliptical shape, an outer convex surface and an inner concave surface. A peripheral side edge located between the inner and outer surfaces terminates in a bead edge. A flexible airtight membrane has a membrane edge bonded to the outer shell surface adjacent to the bead edge. Preforming the membrane edge looped with a maximum linear span of curvature that is greater than a maximal transverse linear extent of the bead edge, membrane operational wear during inflation and deflation cycles is reduced in the region around the bead edge. A process of forming a blood pump with a membrane preform is also provided.

Abstract: A cardiac assist device synchronization system includes a cardiac assist device and an acoustic or accelerometer sensor that provides a signal input to the cardiac assist device indicative of aortic valve closure. The cardiac assist device is coupled to a mammalian aorta and includes an inflatable chamber and a fluid pump. A fluid conduit is in communication between the chamber and the pump to provide for selective inflation of the chamber. A pump controller triggers the pump in counter-pulsation to a mammalian heart upstream from the aorta. A process for synchronizing a cardiac assist device in counter-pulsation with a left ventricle includes locating an acoustic or accelerometer sensor within a thoracic cavity of a mammal having the assist device coupled to the aorta of the mammal.

Abstract: An implantable aortic blood pump includes a rigid body having wall extending along a long axis and defining an inflation port portion with an inflation aperture therethrough. The aperture is fluid communication with an inner surface of the body and on a fluid supply, the body is preferably independent of an external brace or an external stiffener, yet still has a cantilevered deformation of less than 8 millimeters in response to a 200 gram weight suspended from a front body edge. A deflecting structure of a membrane deflects in response to fluid pressure so as to pump blood when the pump is secured to a subject aorta.

Abstract: A blood pump for placement in an incision in an aorta is provided that after placement contacts blood passing through the aorta. The pump inflates and deflates in order to provide left ventricular assistance. The pump has an elongated shell with a generally elliptical shape, an outer convex surface and an inner concave surface. A peripheral side edge located between the inner and outer surfaces terminates in a bead edge. A passage is provided through the shell to provide fluid communication between the outer surface and inner surface. A flexible airtight membrane has a membrane edge bonded to the outer shell surface adjacent to the bead edge to form an enclosed internal chamber in fluid communication with the passage. Preforming the membrane edge looped with a maximum linear span of curvature that is greater than a maximal transverse linear extent of the bead edge, membrane operational wear during inflation and deflation cycles is reduced in the region around the bead edge.

Abstract: A cardiac assist device synchronization system includes a cardiac assist device and an acoustic or accelerometer sensor that provides a signal input to the cardiac assist device indicative of aortic valve closure. The cardiac assist device is coupled to a mammalian aorta and includes an inflatable chamber and a fluid pump. A fluid conduit is in communication between the chamber and the pump to provide for selective inflation of the chamber. A pump controller triggers the pump in counter-pulsation to a mammalian heart upstream from the aorta. A process for synchronizing a cardiac assist device in counter-pulsation with a left ventricle includes locating an acoustic or accelerometer sensor within a thoracic cavity of a mammal having the assist device coupled to the aorta of the mammal.

Abstract: An aortic blood pump is described that can be inflated and deflated in response to selective communication with a source of pressurized fluid or air. The pump includes a structure adapted to maintain implant stability in the face of mechanical and fluid forces to which it is exposed in situ. The pump may include a wall adapted to maintain implant stability by connection of the wall to a stiffening element, such as a stent, a brace, a stiffener or any combination of these. Additionally, the pump optionally includes a wall adapted to maintain implant stability by configuring the interior volume to generally follow the contour of the native human aorta.

Abstract: A protective assembly for a protruding portal shields a neck portion of the portal. The protective assembly is well suited for shielding a percutaneous access device during surgical implantation. The protective assembly includes a lid seating pin configured to seat within the interior of the portal and a lid secured to the pin extending over exterior portions of the portal and gapped from the portal face and the neck. Optionally, the pin inserts within a temporary turret engaging the interior of the portal.

Abstract: An apparatus for assisting cardiac function of a patient includes an inflatable chamber operably positionable with respect to an aorta of the patient, a percutaneous access device implantable with respect to a hypogastric region of the patient and connectible in fluid communication with the inflatable chamber, and a drive unit connectible through the percutaneous access device for selectively inflating and deflating the inflatable chamber in accordance with a control program stored in memory. The control program controls the drive unit in response to a periodically scheduled patient monitoring routine for measuring values of the physiology of the patient. The control program uses measured values as modified in accordance with the control program and physician programmable parameters for assisting cardiac function of the patient.

Abstract: A trephine device for preparing apertures through a flexible material, such as skin of a patient, including a base plate having an upper surface and an opposed lower surface, where the upper surface has at least one upwardly protruding skin deforming contoured surface. The base plate is adapted to be removably inserted into a pocket surgically prepared in tissue of the patient. The device can include a handle member mounted on and projecting upwardly from the upper surface of the base plate. A clamping member is connected to the trephine device in overlying relationship to the upper surface of the base plate. The clamping member facilitates deformable, clamping, sandwiched engagement of the flexible material between the upper surface of the base plate and the clamping member. When the base plate is inserted into the pocket surgically prepared in the tissue of the patient, the skin of the patient is engageable between the base plate and the clamping member.

Abstract: An apparatus and method for measuring the blood pressure of a patient with a permanent or temporary cardiac assist device throughout an entire cardiac cycle by partially filling the inflatable chamber of the cardiac assist device operatively disposed with respect to an aorta with pressurized fluid and using the partially filled chamber as a transducer. An external pressure sensor is located in a drive unit connected to the inflatable chamber. The drive unit controls, monitors and stores the fluid pressure with respect to the inflatable chamber. When isolated from a pressurized fluid reservoir, the pressure within the inflatable chamber corresponds to the current blood pressure of the patient throughout the cardiac cycle. The inflatable chamber preferably is defined at least in part by a flexible membrane. The inflatable chamber is partially inflated with a predetermined volume of pressurized fluid from the reservoir.

Abstract: A percutaneous access device implantable beneath the skin of a patient which includes a housing having a flange positionable beneath the skin and neck projecting outward through the skin. The percutaneous access device includes electrical communication through the flange and fluid access through the flange. The components providing fluid access and electrical communication are removable through the neck portion of the implant for testing and service as required without the need for further surgery on the patient. A turret body is received within the hollow interior of the neck having a fluid channel extending therethrough and containing current limiting devices securely disposed within the turret body.

Abstract: A percutaneous access device includes a body having a horizontal disc-like base flange and a frusto conical projection extending centrally upwardly from one side of the base flange. An elongate flexible tube extends loosely through a bore through the projection and base flange and is sealingly bonded to the body adjacent the bottom of the bore. A coating of a silicone-polycarbonate is applied to the outer surface of the projection and is formed with a multiplicity of microscopic pores to facilitate the bonding of dermal cells to the device upon implantation. The body is of a relatively soft, flexible, biocompatible material so that the device absorbs forces tending to displace the implanted device.

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.