Heart booster: a pericardial support device.

BACKGROUND: Congestive heart failure is a pervasive disease afflicting millions of people. For many, their quality of life can be significantly improved by a pericardial device that can enhance cardiac output without the added risk of thromboembolism associated with direct blood contact. METHODS: A cardiac assist device with tubular elements is wrapped around the heart. Fluid is pumped into and out of the wrap causing contraction and dilation of its circumference. This contracting and relaxing action generates cardiac assistance without the need to contact blood. In vitro characterization and in vivo studies in calves were conducted to demonstrate the characteristics of the device. RESULTS: In vitro characterization with the device wrapped around one-half of a ventricle to simulate left ventricular support demonstrated outputs of 6.5 L/min at physiological afterloads. In vivo studies in calves demonstrated both cardiac output and afterload enhancements when the device is activated. CONCLUSIONS: This study provides a first demonstration of a device that provides cardiac support by a contraction and relaxation scheme with the device wrapped around the epicardium of the heart. The main feature of this actuation method is the potential for building a small device for implantation without blood contact.

Long-term mechanical circulatory support system reliability recommendation: American Society for Artificial Internal Organs and The Society of Thoracic Surgeons: long-term mechanical circulatory support system reliability recommendation.

Jointly developed by members of the American Society for Artificial Internal Organs and the Society of Thoracic Surgeons along with staff from the Food and Drug Administration, the National Heart, Lung and Blood Institute and other experts, this recommendation describes the reliability considerations and goals for Investigational Device Exemption and Premarket Approval submissions for long-term, mechanical circulatory support systems. The recommendation includes a definition of system failure, a discussion of an appropriate reliability model, a suggested in vitro reliability test plan, reliability considerations for animal implantation tests, in vitro and animal in vivo performance goals, the qualification of design changes during the Investigational Device Exemption clinical trial, the development of a Failure Modes Effects and Criticality Analysis, and the reliability information for surgeons and patient candidates. The document will be periodically reviewed to assess its timeliness and appropriateness within five years.

A tubular pediatric ventricular assist device. Design considerations and system characteristics.

A clinical need exists for the short-term use of pediatric ventricular assist device in children and small infants who are critically ill with heart failure unresponsive to pharmacologic support or, in the case of irreversible heart failure, as a bridge to a transplant device. The design considerations and device characteristics of a tubular pump are presented. The device consists of an integrally formed inflow valve, pump chamber, and outflow valve in a tubular construction. This design approach was selected due to its simplicity of fabrication, which can result in a reliable and low cost device. The inflow valve and pump are actuated pneumatically through a single drive line. The outflow valve can be either actively actuated or operated passively. A 5 ml stroke volume device was built and characterized in vitro and in vivo. This pump can generate 0.5 L/min at 100 beats per minute. Larger stroke volume devices can be and have been fabricated using the same principle.

Indirect bronchial shunt flow measurements in AbioCor implantable replacement heart recipients.

Bronchial shunt flows in the recipients of the electrohydraulic AbioCor implantable replacement heart have been measured indirectly. A built-in compliance chamber accommodates the differential flow output required of the two ventricles of the AbioCor. An occluder mechanism regulates the flow differential. For a thoracic unit, given a beat rate, an occluder setting, and the pressure differentials across the replacement heart ventricles, the atrial pressure difference depends only on the level of shunt flow present in the vasculature. For a replacement heart recipient, the bronchial shunt is the dominant shunt flow. For patients implanted with the AbioCor, the beat rates and the occluder settings are known and the pressure differentials across the ventricles are estimated. Atrial pressures were measured using catheters. The bronchial shunt flow was deduced from in vitro characterization data based on these parameters. Available data from five patients in the ongoing clinical trial of AbioCor showed 0-1.4 L/minute bronchial shunt flows. Maximum variation for any individual patient was 1.1 L/minute.

An atrial hydraulic shunt in a total artificial heart. A balance mechanism for the bronchial shunt.

An implantable TAH must be able to maintain physiologic atrial pressures over a range of left side shunt flows, which in humans can range up to 5% of the total cardiac output (CO). The authors describe the characteristics of an atrial hydraulic shunt in an electrohydraulic TAH. A small (10 cc stroke) chamber placed in line between the left atrial cuff and the inflow valve is shunted to the right hydraulic chamber. High left atrial pressure increases the volume displaced by this chamber; this concurrently reduces the right chamber stroke volume and flow relative to the left side. For left atrial pressures (LAP) between 0 and 15 mmHg, CO increased from approximately 3 to > 9 L/min (Starling-like behavior). This was attainable with bronchial flow settings between 0.2 to 0.7 L/min, satisfying physiologic needs. Left atrial pressure and RAP (right atrial pressure) tracked each other. The mean difference, LAP-RAP, remained within 5 mmHg at low filling pressures and approached 0 mmHg difference at high filling pressures. The results showed that the atrial hydraulic shunt method can adequately compensate for and manage physiologic left-right flow differences.

Life testing of implantable batteries for a total artificial heart.

Although lithium cells may promise to be ideal as a rechargeable internal battery for a TAH, NiCd cells remain the most easily accessible off the shelf energy source. Twelve 1.2 A.hr prismatic NiCd (Sanyo, San Diego, CA) cells in series are being tested under the load condition of our TAH. The load consisted of a 1.5 A DC current with 1 A pulses of 40 msec duration at 3.33 Hz (100 bpm), a condition that can generate up to 8 L/min of cardiac output at physiologic pressures. Cells were tested at 37 degrees C. Cell voltages and temperatures were monitored. Testing was accelerated to five charge/discharge cycles per day. Discharge was terminated when any one cell dropped below 1.1 V. Charging (C/4) was continued until the battery voltage indicated a change in slope. Cell temperatures remained below 42 degrees C throughout the charge/discharge cycle. The battery pack settled to a nearly constant capacity of over 25 min after 10 cycles and has accumulated more than 1,000 cycles. Voltage differences among cells were small (SD < 25 mV), indicating consistency among cells. NiCd cells can serve as a reliable interim for TAH internal battery application.

Chronic in vivo evaluation of an electrohydraulic total artificial heart.

Development of the Abiomed total artificial heart (TAH) designed for human use is progressing. Implant durations of longer than 60 days have been achieved in calves. The device consists of blood pumps, valves, and a hydraulic atrial flow balancing chamber fabricated from polyetherurethane. The energy converter, a centrifugal hydraulic pump with a rotary fluid switching valve, is positioned between the blood pumps. In two consecutive chronic in vivo studies (47 days and longer than 60 days), cardiac output was maintained in excess of 8 l/min. The atrial flow balancing chamber maintained a mean right-to-left pressure gradient of 7.5 and -1.4 mmHg in each respective study. There were no pulmonary complications. Platelet counts, fibrinogen concentrations, and hematocrit values returned to baseline levels within 20 days, whereas bilirubin, serum glutamic-oxaloacetic transaminase, blood urea nitrogen, and creatinine levels returned to normal within 1 week of implant. After the first post-operative day, plasma free hemoglobin levels of less than 10 mg/dl indicated no device-related hemolysis throughout the duration of the studies. At explant (47 day study), pathologic analysis showed no renal infarcts, no tissue necrosis, and no thermal damage. The device was fully encapsulated by 2-4 mm thick fibrous connective tissue. A newly designed textured-to-smooth surface inflow showed no signs of pannus ingrowth or thrombotic complications. These studies demonstrate that this TAH is suitable for long-term implantation.

A compact and noise free electrohydraulic total artificial heart.

The ABIOMED total artificial heart (TAH) is designed for long-term tether-free use in patients with end-stage heart disease. Blood pumping is achieved through hydraulic fluid motion across flexing diaphragms. The hydraulic power is derived from a miniature centrifugal pump (50% efficiency). Flow directional change needed for alternate left and right filling and ejection is achieved with a rotary valve. With no mechanical contact with the flexing membrane, the wedge angle between the two pumps sandwiching the energy convertor can be easily optimized for anatomic fit. The blood pumps (80 ml strokes) are fitted with trileaflet polyetherurethane valves (24 mm). The TAH is implanted using twist-lock stepless quick connectors to the inflow cuffs and outflow grafts. Left-right flow balance is achieved with an atrial hydraulic shunt placed between the left cuff and inflow valve. Animal studies show that the TAH fits very well in Long Horn calves weighing 90 to 100 kg and can provide cardiac output in excess of 10 L/min. A cadaver (85 kg) study showed the TAH fits within the pericardial region.

Progress in the development of the ABIOMED total artificial heart.

The ABIOMED implantable total artificial hearts in the final phase of engineering development. The system has a compact electrohydraulically driven energy converter sandwiched between two blood pumps, an internal electronics pack, an internal battery, a transcutaneous energy transmission coil for power transmission, and external wearable electronics pack and battery. The current effort is to complete development of the system during 1996 in preparation for formal pre clinical testing of the device. In vivo studies with the current thoracic unit (ABH II) have achieved 108 days of survival verifying the thermal, physiologic, and hematologic compatibility of the system. The abdominal implantable electronics pack showed no thermal dissipation problem. System improvements include scaling down the size of the thoracic unit, and efficiency enhancement in the power and hybrid electronics. The new system (ABH III) retains the flow capacity of greater than 10 L/min. Size reduction results in an atrial to sternal dimension that would fit 98% and 75% of men and women, respectively.

Long-term mechanical circulatory support system reliability recommendation: American Society for Artificial Internal Organs and Society of Thoracic Surgeons: long-term mechanical circulatory support system reliability recommendation.

Jointly developed by members of the American Society for Artificial Internal Organs and the Society of Thoracic Surgeons along with staff from the Food and Drug Administration, the National Heart, Lung and Blood Institute and other experts, this recommendation describes the reliability considerations and goals for Investigational Device Exemption and Premarket Approval submissions for long-term, mechanical circulatory support systems. The recommendation includes a definition of system failure, a discussion of an appropriate reliability model, a suggested in vitro reliability test plan, reliability considerations for animal implantation tests, in vitro and animal in vivo performance goals, the qualification of design changes during the Investigational Device Exemption clinical trial, the development of a Failure Modes Effects and Criticality Analysis, and the reliability information for surgeons and patient candidates. The document will be periodically reviewed to assess its timeliness and appropriateness within five years.

Design considerations for bearingless rotary pumps.

The designs of rotary blood pumps have shown substantial technical progress over recent years, especially contact bearing designs. However, the concern for potential thromboembolism remains and can only be eliminated by the use of bearingless pumps. Bearingless designs can be achieved through the application of magnetic, hydrodynamic, and hydrostatic forces or a proper combination of these forces. Although a purely magnetically suspended, actively controlled system can be designed, judicious use of hydraulic forces can allow simplification of device configuration and control. In this study, bearingless designs were evaluated for both axial and centrifugal pump configurations. Trade-offs between shear rates and bearing leak rates were considered based upon constraints imposed by hemolysis and residence time. These principles were used for determining the design feasibility of a rotary pump using combined magnetic and hydraulic stabilizing forces.

Absolute oil fluorescence conversion efficiency.

A conceptual method has been developed to deduce the characteristic infinite thickness absolute conversion efficiencies of oils from measured finite thickness film fluorescent returns. The sea water Raman signal is used as a reference in deducing the fluorescent efficiencies. The former can be obtained absolutely by measuring its temporal behavior, from which an absolute conversion efficiency of an oil can be deduced, without any a priori knowledge of the oil. The effects of signal-to-noise and background fluorescence on the accuracy of the fluorescent efficiency measurement are considered.

A unique left-right flow imbalance compensation scheme for an implantable total artificial heart.

A new method has been developed for accommodating the difference between pulmonary and arterial flows in a totally implantable, hydraulically actuated total artificial heart (TAH). The left and right sides are alternately pumped, with concurrent filling of one pump and ejection from the other. A small hydraulic fluid chamber is used to compensate for the higher left sided flow. This chamber is incorporated into the left inflow of the TAH, with the flexing bladder in contact with atrial blood, and the hydraulic fluid communicates with the right sided hydraulic chamber. The volume of hydraulic fluid that enters and exits the latter chamber constitutes a corresponding reduction in the right sided blood chamber stroke volume. Placement of this compensation chamber in the left side inflow provides a negative feedback of the right sided flow, based on the left atrial pressure (LAP). Higher LAP (indicating too much right sided flow) leads to higher fluid flow to and from the compensation chamber and a lower right sided blood flow and vice versa. The hydraulic flow resistance can be preadjusted to yield a 15% flow difference at an LAP of 15 mmHg.

Temperature as a periodontal diagnostic.

Elevated temperature, normally a characteristic of inflammation, is a potential indicator of periodontal disease. Conversely, local periodontal site temperatures within normal variation could suggest relative periodontal health. To evaluate this potential, a temperature probe was designed with rapid response (less than 1 s), high accuracy and reproducibility (+/- 0.1 degree C), good transducer thermal isolation and physical dimensions approximating those of a conventional periodontal probe. To compensate for subject-to-subject variations in core temperature, site temperatures were measured and expressed as differences relative to the sublingual temperature. A cross sectional study was conducted using this instrument in which pocket temperatures of 14 subjects with advanced adult periodontitis were measured and compared with the sulcus temperatures of 11 healthy subjects. Overall, the mean site temperature of the diseased subjects was 0.65 degree C higher than that of the healthy subjects. A natural posterior-to-anterior temperature gradient was observed with the posterior sites being hotter than the anterior sites. Tooth-by-tooth analysis showed that diseased teeth have higher temperatures than anatomically equivalent healthy teeth (p less than 0.01). Threshold temperatures for differentiating diseased and healthy teeth were determined to optimize sensitivity and specificity. The results suggest that site temperature is a diagnostic of inflammatory activity associated with periodontal disease. The specifically designed instrument detected significant disease-related departures from normality.

A magnetically suspended and hydrostatically stabilized centrifugal blood pump.

A magnetically suspended centrifugal blood pump intended for application as a long-term implantable ventricular assist device has been built and tested. The rotor is freely suspended in the blood by magnetic and hydrostatic restoring forces. This design obviates the need for bearings and shaft seals, and eliminates the problems of reliability and thrombogenicity associated with them. The positional stability and hydrodynamic performance of the pump has been characterized in vitro at flows of up to 10 L/min at physiologic pressures. Radial position control is realized by an analog electronic feedback control system. The pressure distribution in the fluid surrounding the rotor provides dynamic control in the axial direction with no active feedback. Rotor excursion is less than 50 microns (mu) when the housing receives an impulse peaking at an acceleration of 40 g or upon sudden blockage of the flow. In vitro blood measurements indicate an acceptable level of hemolysis compared with that of a standard centrifugal pump.

Development of an efficient electrohydraulic total artificial heart.

The efficient use of space and energy is achieved in a new implantable total artificial heart (TAH). To fit the orthotopic thoracic space, toroidal blood pumps encircle an energy converter, consisting of a centrifugal hydraulic fluid pump and a rotary reversing valve. The new centrifugal pump produces cardiac outputs of 6 L/min, with an average hydraulic efficiency of 47%. Toroidal blood pumps encircling the pump deliver a 60 cc stroke with an 85% ejection fraction and have a predictable blood flow pattern with no stagnant regions. Components have been characterized in vitro, and blood contacting elements have been tested in vivo.