A device (22) for insertion into the heart wall (25) suited for Trans Myocardial Revascularization (TMR) providing means for the delivery from the heart chamber into the heart wall (25) of blood nutrients. The device (22) has a hollow cylindrical body (21) containing a cavity and side ports (23) situated within that cavity. The cavity is in fluid communication with the heart chamber. The side ports (23) are in fluid communication with the heart wall (25). Distal and proximal end regions of the device (22) provide means (65) to secure the device in the heart wall. In addition, a system (36) for the insertion of the device (22) including a tubular body (40) and a needle point (43) is disclosed. A method for TMR includes the steps of displacement of myocardial tissue, or creation of a channel in that tissue, and placement into heart wall (25) of a stent (22) in the space generated by displaced tissue or channel.

Device and method for trans myocardial revascularization

Evaluation of explanted polyurethane trileaflet cardiac valve prostheses

This article describes the clinical course of four patients in whom the Jarvik-7-100 total artificial heart was implanted as a permanent device. Details of their preoperative assessment and comprehensive summaries of their postoperative course are presented. The neurological, hematological, renal, and infectious complications they experienced and the interventions initiated to achieve resolution of these problems are described. Finally, revisions in the treatment protocols as a consequence of the experience and knowledge gained are examined. ( JAMA 1988;259:849-859)

https://jamanetwork.com/HttpHandlers/ArticlePdfHandler.ashx?journal=jama&articleId=370569&pdfFileName=jama_259_6_024.pdf

The permanent artificial heart. Four case reports.

A medical assembly, such as an artificial heart assembly, adapted to be implanted within a living subject is composed of an implantable data communications interface adapted to receive an encoded data signal from a data communications interface located outside the subject at a position remote from the medical assembly. The encoded data signal is transmitted in a plurality of periodic signal bursts, which are transmitted at a first frequency to represent a first data value and a second frequency to represent a second data value. Each of the bursts comprises a plurality of signal transitions having a third frequency greater than both the first and second frequencies.

Communication method for implantable medical device

In one embodiment described in the specification, a surgically implantable reciprocating pump employs a check valve as the piston, which is driven by a permanent magnet linear electric motor to assist either side of the natural heart The pump is implanted in the aorta or pulmonary artery using vascular attachment cuffs such as flexible cuffs for suturing at each end with the pump output directly in line with the artery The pump is powered by surgically implanted rechargeable batteries In another embodiment, pairs of pumps are provided to replace or assist the natural heart or to provide temporary blood flow throughout the body, for example, during operations to correct problems with the natural heart

Implantable device monitoring arrangement and method

The in vitro development of automatic control of the actively filled, alternately pumped, volumetrically coupled, electrohydraulic total artificial heart was the goal of this investigation. Control features under study were (a) cardiac output (CO) response to preload; (b) CO relationship to mean aortic pressure (AoP); and (c) control of balanced ventricular outputs. A modified pulmonic valve to increase backflow was used as a balancing mechanism. Hydraulic fluid pressure transducers monitored diastolic pressures, and microprocessor control of motor speed maintained in a mild suction to yield filling rate dependent on atrial pressure. Results indicated a rise in CO from 5 to 9 L/min, with a change in mean right atrial pressure (RAP) from 0 to 7 mm Hg. No significant difference in CO was found as AoP was varied from 80 to 120 mm Hg with a maximum variation of +/- 0.5 L/min on CO and +/- 1 mm Hg on RAP. Balance was maintained for bronchial flows up to 50% with mean left atrial pressure never exceeding 15 mm Hg. An alternately pumped electrohydraulic heart was automatically controlled to respond sensitively to preload changes. Afterload changes did not alter the CO response curve. Automatically controlled, balanced ventricular outputs were maintained.

In vitro development of automatic control for the actively filled electrohydraulic heart.

A recently designed blood pump subsystem for the completely implantable electrohydraulic total artificial heart (EHTAH) has been developed and is under evaluation. The subsystem consists of joined left and right ventricles, atrial cuffs with an interatrial shunt (IAS), and two outflow grafts. The ventricles were developed to fit within the pericardial space based on the results of anatomic fit trials. An optimized configuration for animal use, which was adaptable for human use with minimal modification, was identified. The core dimensions of the ventricles with an energy converter are approximately 10 x 11 x 7 cm. Maximum output and stroke volume are 9.2 L/min and 81 ml, respectively. The IAS is used to balance the volumetrically coupled EHTAH, and is made by forming an orifice in the common septum of the left and right atrial cuffs. Performance and durability of the IAS were examined in animal experiments for up to 9 days. The diameter of the IAS was 3.4-5.5 mm, and the left-right atrial pressure difference ranged from 2 to 10 mmHg, with 0.57-1.48 L/min of theoretically calculated shunt flow. No evidence of thrombus formation was found in or around the IAS at autopsy. The entire EHTAH system with a new blood pump is being assembled for long-term animal studies.

A blood pump with an interatrial shunt for use as an electrohydraulic total artificial heart.

An electrohydraulic ventricular assist device has been developed. An axial flow pump driven by a brushless DC motor provides actuation. Energy is supplied by internal Ni/Cd batteries and by external Ag/Zn batteries, both rechargeable. Electromagnetic induction is used to pass energy through the skin with a transcutaneous energy transfer (TET) system. Physiologic control, battery management, motor commutation, and communication functions are performed by a surface mount internal controller. An infrared data link within the TET coils provides bidirectional communication between the external and internal controllers. A computer model was developed to predict system performance. The dimensions are 180 mm x 116 mm x 40 mm. An in vitro system pumped 5.7 L/min at 10 mmHg inflow and 100 mmHg outflow pressure. The internal battery can provide the projected energy requirements for 40 min after 540 charge/discharge cycles, and the external battery is capable of 4 hr of operation after 150 cycles. The TET system can deliver 60 W of power and exceeds 80% efficiency between 15 and 30 W. The device configuration is based on human cadaver and intraoperative fit trials. The device is being modified for calf implantation by redirecting the blood ports, increasing the output, and incorporating the internal controller in the unified device base.

Electrohydraulic ventricular assist device development.

Mechanical failures in in vivo and in vitro studies of pneumatic total artificial hearts.

Evaluation of treadmill exercise on total artificial heart recipients.

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