Biomedical subjects

R Benkowski

Publications and source records attributed to R Benkowski.

At least 19 recordsLinked to original sources

PubMed2001

Turbine blood pumps.

After years of development and preclinical testing, clinical trials of the MicroMed DeBakey VAD began in November 1998 in Europe and in June 2000 in the United States. As of August 2000, 44 patients in Europe and 3 patients in the United States have undergone implantation with the MicroMed DeBakey VAD. In conclusion, data from the European clinical trial of the MicroMed DeBakey VAD support the safety and performance of the device. Results show that the device provides adequate left ventricular and circulatory support in patients with end-stage heart failure without unduly jeopardizing patient safety. Moreover, the device provides advantages not inherent to commercially available pulsatile devices: (1) miniature size, enabling implantation in smaller patients; (2) ease of implantation; (3) reduced surgical bleeding; and (4) a low incidence of postoperative infections, often a limiting factor with other devices. The MicroMed DeBakey VAD European clinical trial is the first demonstration of the compatibility of continuous blood flow with adequate tissue perfusion and overall maintenance of life for up to 4.5 months. This initial experience with the MicroMed DeBakey VAD suggests that the pump can provide circulatory support to bridge patients to cardiac transplantation and may provide an improved quality of life for the patient with end-stage heart failure.

Animals↗

PubMed2000

Development and clinical application of the MicroMed DeBakey VAD.

A miniaturized axial flow pump to provide left ventricular assistance has been developed. Such a device has the potential to address limitations of the larger pulsatile devices. Clinical trials of the MicroMed DeBakey VAD (ventricular assist device) began in Europe in November 1998. As of December 1, 1999, 18 patients have been implanted with the MicroMed DeBakey VAD. Hemodynamic evaluations along with blood chemistry analysis were recorded routinely. Exercise tolerance was observed. In most patients, end-organ function has improved and has not deteriorated in any patient. Patients have been able to perform normal low-level activity and have tolerated positional changes without evidence of postural hemodynamic changes. Select patients have taken supervised out-of-hospital excursions. This initial clinical experience with the MicroMed DeBakey VAD suggests that the miniaturized axial flow pump can provide ventricular support to bridge patients to cardiac transplant and may provide an improved quality of life for the end-stage heart failure recipient.

Activities of Daily Living↗

PubMed1999

The DeBakey ventricular assist device: current status in 1997.

In 1993, the development began of a small axial flow blood pump, the DeBakey ventricular assist device (VAD). The material was recently converted to a titanium alloy, and a waterproof pump package was incorporated for long-term intracorporeal circulation. Thirteen intrathoracic implantations in calves were achieved. Nine animals survived the 2 week perioperative period and were supported for a range of 26-93 days. The first study had low flow due to poor anatomical fit of the straight cannula. In contrast, a curved cannula used subsequently provided a good anatomical fit with sufficient flow. Mean flow of 4.4 L/min was sustained with 9,900 rpm and required power was an average of 8.8 W. No thromboembolic evidences were observed in any case, and the plasma free hemoglobin level was maintained lower than 5 mg/dl, except in the early postoperative period. Three animals were terminated because of bleeding due to anticoagulant mismanagement. Electric interference (n = 1) and drive line breakage/fault (n = 2) were observed as device-related failures. Minor modifications were made to the drive line. In conclusion, the DeBakey VAD demonstrated adequate basic performance and biocompatibility. The highly reliable mechanical components and improved electrical parts are promising for a long-term implantable cardiac prosthesis.

Animals↗

PubMed1999

Chronic survival of calves implanted with the DeBakey ventricular assist device.

The DeBakey ventricular assist device (VAD) is a miniaturized, electromagnetically driven axial flow pump capable of generating in excess of 10 L/min output. The VAD was evaluated in 19 calves during experiments designed to test iterative modifications in the system and to determine the safety of the DeBakey VAD for intermediate to long-term implant. Five of the animals died or were euthanized during the perioperative period (i.e., Days 1-5) due to complications associated with bleeding (n = 3), sudden cardiac arrest (n = 1), or pump occlusion due to a muscle remnant associated with coring (n = 1). The remaining 14 animals survived from 7-145 days. Ten of the 14 animals survived 30 or more days, and 2 animals survived 93 and 145 days before elective euthanasia. Pump function was evaluated in the 14 calves that survived beyond the perioperative period. Pump output at implantation averaged 3 L/min while output at 100 days (n = 2) averaged 4.22 L/min. The electrical current did not change across time during the study, indicating normal operation of the bearings. Pumps consumed less than 10.5 W of power for all support durations. Hemolysis did not occur; the average daily plasma free hemoglobin varied from 2.0 to 8.0 mg/dl. Evaluation of serum biochemical data showed that implantation of the DeBakey VAD in calves with normal hearts did not impair end organ function; BUN, creatinine, and total bilirubin varied minimally within the normal range. The white blood cell count of implanted animals remained within the normal range throughout the study.

Animals↗

PubMed1998

Protein adsorption onto ceramic surfaces.

Ceramics seldom have been used as blood-contacting materials. However, alumina ceramic (Al2O3) and polyethylene are incorporated into the pivot bearings of the Gyro centrifugal blood pump. This material combination was chosen based on the high durability of the materials. Due to the stagnant flow that often occurs in a continuous flow condition inside a centrifugal pump, pivot bearing system is extremely critical. To evaluate the thombogenicity of pivot bearings in the Gyro pump, this study sought to investigate protein adsorption, particularly albumin, IgG, fibrinogen, and fibronectin onto ceramic surfaces. Al2O3 and silicon carbide ceramic (SiC) were compared with polyethylene (PE) and polyvinylchloride (PVC). Bicinchoninic acid (BCA) protein assay revealed that the amount of adsorbed proteins onto Al2O3 and SiC was significantly less than that on PVC. The sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) indicated that numerous proteins adsorbed onto PVC compared to PE, Al2O3, and SiC. Identification of adsorbed proteins by Western immunoblotting revealed that the adsorption of albumin was similar on all four materials tested. Western immunoblotting also indicated lesser amounts of IgG, fibrinogen, and fibronectin on Al2O3 and SiC than on PE and PVC. In conclusion, ceramics (Al2O3 and SiC) are expected to be thromboresistant from the viewpoint of protein adsorption.

Adsorption↗

PubMed1998

The safety system for the rotary blood pump, combination of the valve and LVAD pulsatile mode: in vitro test.

The significant amount of regurgitation produced by a stopped rotary blood pump is one of the major considerations for its use as an implantable left ventricular assist device (LVAD), especially if the pump accidentally stops. The installation of a valve is an option for the solution of this potential problem. However, this option may lead to thrombogenic problems, particularly if the valve motion is restricted. This in vitro study analyzes the valve performance and assesses the credibility of a rotary blood pump valve. A pulsatile pump was used as the natural heart and a centrifugal pump as the LVAD. The valve was positioned into the LVAD outflow. In the low speed range (<1,000 rpm in this test condition), normal valve motion was maintained. Also, the valve model provided a higher mean bypass flow than the model without a valve due to reduced regurgitation. However, the valve motion was drastically restricted when in the high speed range (>1,600 rpm in this condition). The pulsatile mode was applied to the LVAD by periodically changing the impeller speed (40 bpm); subsequently, a constant valve motion could be provided. A possibility exists that this pulsatile mode application could eliminate thrombosis formation around the valve. A conclusion was made that the combination of a valve and an LVAD in a pulsatile mode is considered to be a unique safety system for a rotary blood pump.

Blood Pressure↗

PubMed1997

Mapping of pump efficiency on the pressure-flow curve of a centrifugal blood pump.

Because pump efficiency is closely related to heat generation and blood trauma in a centrifugal blood pump, it is quite important to study pump efficiencies in a variety of conditions. In the present study, pump efficiencies were mapped on the pressure head-flow rate curves of 4 different pumps; BioMedicus BioPump (BP-80), Nikkiso (NK), Gyro C1E3, and Gyro PI601 (diameter of the impeller, NK: 50 mm, C1Ee3: 65 mm, and PI601: 50 mm). The mapping of pump efficiency revealed the following findings. First, the cone type (BP-80) has less pump efficiency than the impeller type (NK and C1E3); second, the miniaturization of the C1E3 to the PI601 has resulted in an increase in pump efficiency; and third, the diameter of the impeller may contribute to the pump efficiency of an im peller type pump. The mapping of the pump efficiency, as demonstrated in this study, is useful for the analysis of hydraulic pump performance in a wide range of clinically applied conditions.

Blood Flow Velocity↗

PubMed1997

Material of the double pivot bearing system in the Gyro C1E3 centrifugal pump.

A double pivot bearing system is adopted for the Gyro C1E3 centrifugal blood pump to achieve a completely sealless structure that prevents blood leakage and thrombus formation around the shaft. The double pivot bearing system is also a critical factor for blood trauma and durability of the C1E3 pump. This study focuses on the double pivot bearing material. The pump with the male ceramic and female polyethylene pivots (PE) was compared with the pump with the male ceramic and female ceramic pivots (CRM), pertaining to stability of the impeller spinning motion, hemolysis, and durability. At first, the wear rate of the pivots was recorded after operating the pumps in various rotational speeds. As for hemolysis, in vitro tests were carried out using fresh bovine blood in 2 conditions (5 L/min, 350 mm Hg and 5 L/min, 100 mm Hg). Then, stability of the spinning motion was investigated by evaluating the vibration of the pump. The two pumps with different female pivots were operated identically at 2,700 rpm, and the vibration signals were measured using an accelerometer that was mounted on the top of the pump housing. The following findings were obtained in this study. The wear sites were different between the PE and CRM. Most of the wear occurred at the top female polyethylene pivot in the PE. In contrast, most of the wear occurred at the top male ceramic pivot in the CRM. In addition, the amount of the initial wear was less and the wear rate was lower in the PE than in the CRM. The hemolysis caused by the PE was less than the hemolysis caused by the CRM. The vibration signals of the PE had less amplitude and a narrower range of frequency than the vibration signals of the CRM. In conclusion, the combination of materials male ceramic-female polyethylene are superior to the male ceramic-female ceramic for the double pivot bearing system of the Gyro C1E3 centrifugal pump because of less vibration, less hemolysis, and less wear.

Animals↗

PubMed1997

Eccentric inlet port of the pivot bearing supported Gyro centrifugal pump.

An eccentric inlet port is a unique feature of the pivot bearing supported Gyro Compact-1 Eccentric Inlet Port Model 3 (C1E3) centrifugal pump, a completely sealless centrifugal pump. The latest C1E3 has an eccentric inlet port with a 30 degree vertical angle. To investigate the adequacy of this 30 degree angle, flow visualization studies and in vitro hemolysis tests were performed, comparing 4 pumps, each with a different angle of the eccentric inlet port (0, 30, 60, and 90 degrees). The flow visualization study utilizing a tracer method focused on the flow pattern just distal to the inlet port of each pump, and each pump was operated at 5 L/min against 100 mm Hg and 5 L/min against 350 mm Hg. In the pumps with angles of 90 and 60 degrees, the flow direction changed horizontally, causing a vortex formation. In the pump with the 30 degree angle, the inflow did not change its course, resulting in minimal space for vortex formation. In the pump with the 0 degree angle, the inflow collided with the pump housing, resulting in a small vortex formation along the housing surface. The in vitro hemolysis tests at 5 L/min against 350 mm Hg revealed that the pump with the 30 degree angle was the least hemolytic and the pump with the 90 degree angle was the most hemolytic among the 4 pumps. These results suggest that the angle of the eccentric inlet port of the Gyro C1E3 pump should be 30 degrees to have less vortex formation and less red blood cell trauma.

Animals↗

PubMed1997

Improved flow straighteners reduce thrombus in the NASA/DeBakey axial flow ventricular assist device.

A small axial flow ventricular assist device (VAD) measuring 3 inches long and 1 inch in diameter is in development. The pump consists of a spinning inducer/ impeller, a flow straightener (FLS), and a diffuser enclosed in a cylindrical flow tube. The impeller has rod-shaped permanent magnets embedded within its 6 blades and is activated magnetically by the motor stator which is positioned outside the flow tube. At the completion of a previous study, the FLS was identified as a thrombogenic area. The aim of the present study was to evaluate the thrombogenicity of redesigned FLSs (swept-back and bulbous types), compared with standard type (STD) FLS. A total of 15 pumps (STD, n = 7; swept-back, n = 4; and bulbous, n = 4) were sequentially implanted into 4 calves paracorporeally in a short-term ex vivo test. The STD and bulbous FLSs experienced thrombus formation, but the swept-back FLS was thrombus free during a 48 h screening test.

Analysis of Variance↗

PubMed1997

Estimation of the minimum pump speed to prevent regurgitation in the continuous flow left ventricular assist device: left ventricular drainage versus left atrial drainage.

Due to the fact that centrifugal and axial pumps do not require valves, there is a possibility of back flow when the pump speed is low. To estimate the minimum required pump speed to prevent this regurgitation, an in vitro simulation test was conducted. A pulsatile pump simulated the natural heart while a centrifugal pump simulated the continuous flow left ventricular assist device (LVAD). The LVAD flow was attained from the left atrial (LA) drainage or left ventricular (LV) drainage. The minimum or regurgitate flow was observed in the systolic phase with LA drainage and in the diastolic phase with LV drainage. LV drainage always provided higher flow than LA drainage at the same pump speed. These differences are due to the various total pressure heads of the LVAD. To prevent the regurgitation, the LVAD should maintain a certain pump speed which can create positive flow against the aortic systolic pressure with LA drainage and against the aortic diastolic pressure with LV drainage. These required pump speeds can be identified by the LVAD flow-pressure curve.

Aortic Valve Insufficiency↗

PubMed1997

Hydraulic assessment of the floating impeller phenomena in a centrifugal pump.

A compact eccentric inlet port centrifugal blood pump (C1E3) has been perfected for a long-term centrifugal ventricular assist device as well as a cardiopulmonary bypass pump. The C1E3 pump incorporates a sealless design and a blood stagnation free structure. The pump's impeller is magnetically coupled to the driver magnet in a sealless manner. The latest hemolysis study reveals that hemolysis is affected by the magnetic coupling distance between the driver and impeller magnet. Furthermore, a floating phenomenon can be observed in a pivot bearing supported pump. Attention was focused on the relationship between the floating phenomenon's characteristics and the magnetic coupling design in the C1E3 pump. Studies were conducted to evaluate the hydromechanical performance in the floating phenomenon. In this study, the relationship between the magnetic coupling design and the floating phenomenon was verified with a smooth spinning condition. The optimized magnetic coupling distance for the floating mode was estimated to be 12 mm for left ventricular assist device and 9 mm for cardiopulmonary bypass pump. Obtaining an optimal spinning condition is required for regulating the magnetic coupling force. To develop a double pivot bearing pump, it is necessary to establish an optimal spinning and/or floating condition and to determine the proper magnetic coupling and magnetic force between the impeller and driver.

Assisted Circulation↗

PubMed1997

Development and initial testing of a permanently implantable centrifugal pump.

To be able to salvage heart failure patients, the need for an economical permanent ventricular assist device is increasing. To meet this increasing demand, a miniaturized centrifugal blood pump has been developed as a permanently implantable device. The Gyro permanently implantable model (PI-601) incorporates a sealless design with a blood stagnation free structure. The pump impeller is magnetically coupled to the driver magnet in a sealless manner. This pump is atraumatic and antithrombogenic and incorporates a double pivot bearing system. A miniaturized actuator was utilized in this system in collaboration with the University of Vienna. The priming volume of this pump is 20 ml. The overall size of the pump actuator package is 53 mm in height and 65 mm in diameter, 145 ml of displacement volume, and 305 g in weight. Testing to date has included in vitro hydraulic performance and hemolysis. This pump can provide 5 L/min against a 110 mm Hg total pressure head at 2,000 rpm and 8 L/min against 150 mm Hg at 2,500 rpm. The normalized index of hemolysis (NIH) value of this pump was 0.0028 g/100 L at 5 L/min against 100 mm Hg. A preliminary anatomical study revealed the possibility of the implantability of 2 such systems in biventricular bypass at a preperitoneal location. This system is feasible for use as a permanently implantable biventricular assist device.

Animals↗

PubMed1997

Hemolytic effect of surface roughness of an impeller in a centrifugal blood pump.

The present study investigates how the surface roughness of an impeller affects hemolysis in the pivot bearing supported Gyro C1E3 pump. This study focuses on particular areas of the impeller surface in the impeller type centrifugal pump. Seven Gyro C1E3 pumps were prepared with smooth surface housings and different impeller parts with different surface roughnesses. The vanes, top side, and backside of the impeller were independently subjected to vapor polishing, fine sand blasting, or coarse sand blasting to produce three different grades of surface roughness. These surfaces were then examined by a surface profile instrument. Using these pumps with different impellers, in vitro hemolysis tests were performed simulating cardiopulmonary bypass (5 L/min, 350 mm Hg). The findings of this study conclusively proved that surface roughness of the back side of the impeller has the greatest effect on hemolysis, followed by the top side and then the vanes. The following are reasons for these findings. First, the shear rate may be greater on the back side than on the top side because of the smaller gap between the back and the housing and the greater relative speed against the impeller. Second, the fluid beneath the impeller may have a longer exposure time because there is little chance for the fluid to mix beneath the impeller. Third, the shear rate may be greater on the top side of the impeller than on the vanes because a vortex formation occurs behind the vanes.

Analysis of Variance↗

PubMed1997

Hemolytic effects of surface roughness of a pump housing in a centrifugal blood pump.

The surface roughness of artificial blood contacting devices is an important surface property that is closely related to blood cell trauma. The present study investigated the effect of the surface roughness of a pump housing on hemolysis in an impeller-type centrifugal blood pump, a pivot bearing supported Gyro C1E3 pump. The purpose of the study was to determine which part of a housing has the greatest surface roughness effect on hemolysis in a centrifugal pump. Seven Gyro C1E3 pumps were prepared, each with a smooth surface impeller and a housing with differing areas of altered surface roughness. Both top and bottom housings were divided into half subregions, each with the same area. Seven test pumps were produced by subjecting various subregions of the housings to vapor polishing and sandblasting. The treated surfaces were then examined by a surface profile instrument. Using these 7 pumps with different areas of altered housing roughness, in vitro hemolysis tests were performed simulating cardiopulmonary bypass (5 L/min, 350 mm Hg). The results of this study are as follows. First, the surface roughness of the top housing had a greater effect on hemolysis than that of the bottom housing. Second, on the surface of the top housing, the surface roughness of the outer half area had a greater effect on hemolysis than that of the inner half area. Third, on the surface of the bottom housing, the surface roughness of the inner half area had a greater effect on hemolysis than that of the outer half area. These findings concur with previous studies of flow patterns in pumps. Thus, it is expected that the method in this study, comparative in vitro hemolysis tests of the pumps with surfaces of the same roughness but different locations, can be used to detect the high shear area inside a pump.

Analysis of Variance↗

PubMed1997

A pivot bearing-supported centrifugal pump for a long-term assist heart.

A pivot bearing-supported centrifugal blood pump has been developed. It is a compact, cost effective, and anti-thrombogenic pump with anatomical compatibility. A preliminary evaluation of five paracorporeal left ventricular assist studies were performed on pre-conditioned bovine (70-100 kg), without cardiopulmonary bypass and aortic cross-clamping. The inflow cannula was inserted into the left ventricle (LV) through the apex and the outflow cannula affixed with a Dacron vascular graft was anastomosed to the descending aorta. All pumps demonstrated trouble free performance over a two-week screening period. Among these five studies, three implantations were subjected for one month system validation studies. All the devices were trouble free for longer than 1 month. (35, 34, and 31 days). After achieving one month studies, all experiments were terminated. There was no evidence of device induced thrombus formation inside the pump. The plasma free hemoglobin levels were within normal ranges throughout all experiments. As a consequence of these studies, a mass production model C1E3 of this pump was fabricated as a short-term assist pump. This pump has a Normalized Index of Hemolysis of 0.0007 mg/100L and the estimated wear life of the impeller bearings is longer than 8 years. The C1E3 will meet the clinical requirements as a cardiopulmonary bypass pump. For the next step, a miniaturized pivot bearing centrifugal blood pump P1-601 has been developed for use as a permanently implantable device after design optimization. The evolution from C1E3 to the PI-601 converts this pivot bearing centrifugal pump as a totally implantable centrifugal pump. A pivot bearing centrifugal pump will become an ideal assist pump for the patients with failing heart.

Animals↗

PubMed1996

Effect of surface roughness on hemolysis in a pivot bearing supported Gyro centrifugal pump (C1E3).

The blood contacting surface quality is an important pump parameter for blood compatibility and cell damage. This study investigates the surface roughness and the effect it has on hemolysis in a centrifugal blood pump. In vitro hemolysis tests were performed with a pivot bearing supported Gyro centrifugal pump (C1E3) simulating cardiopulmonary bypass (CPB; 5 L/min, 350 mm Hg) and left ventricular assist device (LVAD; 5 L/min, 100 mm Hg) conditions. To produce 4 different grades of surface roughness, the impellers and housings were subjected to vapor polishing, sand papering, fine sand blasting, or coarse sand blasting. Seven pumps were assembled with different impeller and housing surfaces. These surfaces were then examined by a surface profile instrument and a scanning electron microscope. The results of this study are as follows. First, the effect of surface roughness on hemolysis was significantly greater in the CPB condition than in the LVAD condition. Second, surface roughness, regardless of whether it is the impeller or pump housing, had little effect on hemolysis in the LVAD condition. Third, in the CPB condition, the surface roughness of the pump housing has a greater effect on hemolysis than does that of the impeller. From a hemolytic point of view, an extremely smooth pump housing is required for use of an impeller type centrifugal pump as a CPB device. In contrast, it is conceivable that a smooth surface is not always essential for an impeller type centrifugal pump that is used as an LVAD.

Animals↗

PubMed1996

Ex vivo phase 1 evaluation of the DeBakey/NASA axial flow ventricular assist device.

A small ventricular assist device intended for long-term implantation has been developed by a cooperative effort between the Baylor College of Medicine and the NASA/Johnson Space Center. To date, in vitro tests have been performed to address hemolysis and pump performance issues. In this Phase 1 study, we assessed the durability and atraumatic features aiming for 2 day implantation. Eight pumps were implanted in 2 calves as paracorporeal left ventricular assist devices. The pump running times ranged from 18 to 203 h (78.1 +/- 23.7; mean +/- SEM). All the pump implantations were terminated because of thrombus formation. Plasma-free hemoglobin levels were below 13.7 mg/dl, except for 1 case complicated by inflow cannula obstruction. The pump speed was maintained between 10,100 and 11,400 rpm. Pump outputs were from 3.6 to 5.2 L/min. The electrical power required by the system ranged between 9 and 12 W. Clinically there was no detectable organ dysfunction noted, and postmortem evaluation demonstrated no pump related adverse effects in either calf except for small kidney infarctions. Thrombus deposition was observed mainly at the hub portions and the flow straightener.

Alanine Transaminase↗