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Biomedical subjects

H Schima

Publications and source records attributed to H Schima.

At least 37 records · Page 2Linked to original sources

Microspheres based detoxification system: in vitro study and mathematical estimation of filter performance.

Because of the closed plasma (secondary) circuit in the Microspheres based Detoxification System (MDS), a convective blood purification system, the same amount of filtrated plasma is backfiltrated into the blood circuit. Therefore, there is no direct way to determine the ultrafiltrate production rate, which is an important factor of efficiency. The only possible way to estimate the filtration properties of the filter is to consider pressure values. In this study the pressure distribution in the filter was investigated in vitro. To explain the results and to calculate inaccessible parameters, a mathematical model was established which also considered the asymmetric behaviour of the filter membrane. The result was a linear pressure gradient, agreement with the measurements was reasonably good (calculated primary pressure loss differs <13% from measured value when using mean measured filter resistance as model parameter). Linear pressure distribution offers the possibility of easily calculating the filtration length, a parameter which can be used to estimate the filter condition. The comparison between calculated filtration and backfiltration rates offers an instrument of control for these values.

Adsorption↗

Endothelialization of biosynthetic vascular prostheses after laser perforation.

OBJECTIVE: This study was undertaken to investigate the feasibility of transmural capillary ingrowth into the inner surface of biosynthetic vascular prostheses (Omniflow, BioNova, Melbourne, Australia) through perforations created by an excimer laser, thus inducing an endothelial cell coverage. METHOD: Biosynthetic vascular prostheses (Omniflow, 10 cm length, 6 mm diameter) were perforated with an excimer laser (diameter of the holes 50 to 100 microm, distance 4 mm) and implanted into the carotid arteries of eight sheep. They were compared to untreated Omniflow prostheses implanted at the contralateral side. Three months after implantation the prostheses were explanted and evaluated by gross morphology, histologic examination, scanning electron microscopy, and immunohistochemical staining for factor VIII to identify endothelial cells. RESULTS: All grafts remained patent. Gross morphologic examination revealed no significant difference in the thrombus-free surface between perforated and untreated prostheses. However, scanning electron microscopy showed endothelial cells in the midgraft portion of all perforated prostheses, whereas collagen fibers, fibrin meshwork, and activated platelets formed the inner layer in six of eight untreated Omniflow prostheses. Transmural capillary ingrowth in the laser group was verified by positive factor VIII staining for endothelial cells in the laser channels. CONCLUSION: Spontaneous endothelialization of biosynthetic vascular prostheses can be achieved by transmural capillary ingrowth through perforations in the wall of the prostheses in an experimental sheep model.

Anastomosis, Surgical↗

Experimental development of an electrically stimulated biological skeletal muscle ventricle for chronic aortic counterpulsation.

OBJECTIVE: The chronic shortage of donor organs for cardiac transplantation and the high costs for mechanical assist devices demand the development of alternative cardiac assist devices for the treatment of severe heart failure. Cardiac assistance by stimulated skeletal muscles is currently investigated as such a possible alternative. The goal of the presented study was to construct a newly designed biological skeletal muscle ventricle and to evaluate its possible hemodynamic efficacy in an acute sheep model. METHODS: A total of 14 adult sheep were used for acute experiments. The entire thoracic aorta including the aortic root was excised from a donor sheep. An aorto-pericardial pouch conduit (APPC) was created by enlarging the aortic circumference in its middle section with two strips of pericardium. This biological conduit was anastomosed in parallel to the descending aorta of a recipient sheep, using the aortic root as an inflow valve to the conduit. Stimulation electrodes were applicated to the thoracodorsal nerve and the latissimus dorsi muscle was detached from the trunk and wrapped around the pouch. ECG-triggered functional electrical stimulation was applied during cardiac diastole to simulate aortic counterpulsation. Stimulation was performed during various hemodynamic conditions. RESULTS: A standardised surgical procedure suitable for long term studies was established during six experiments. An APPC, with 70-80 mm filling volume, was found to be of optimal size. In another eight experiments, hemodynamic measurements were performed. Under stable hemodynamic conditions the stimulation of the biological skeletal muscle ventricle induced a significant increase of mean arterial pressure by 14% and mean diastolic pressure by 26%. During pharmacologically induced periods of cardiac failure, the stimulation of the APPC increased mean arterial pressure by 13% and mean diastolic pressure by 19%. In all eight experiments, the diastolic peak pressure reached supra-systolic values during stimulation. CONCLUSIONS: The results demonstrate the hemodynamic efficacy of this newly designed biological skeletal muscle ventricle as an aortic counterpulsation device. Chronic experiments using a preconditioned fatigue-resistant muscle will further help to evaluate its possible clinical significance.

Animals↗

In vivo evaluation of the miniaturized Gyro centrifugal pump as an implantable ventricular assist device.

A miniaturized Gyro centrifugal pump has been developed to be incorporated into a totally implantable artificial heart. The Gyro PI (permanently implantable) model is a pivot bearing supported centrifugal pump with a priming volume of 20 ml. With the miniaturized actuator, the pump-actuator package has a height of 53 mm, a diameter of 65 mm, and a displacement volume of 145 ml. To evaluate the hemocompatibility and efficiency of the Gyro PI pump system, a plastic prototype (Gyro PI-601) was implanted into a bovine model as a left or right ventricular assist device (LVAD or RVAD), bypassing from the left ventricular apex to the descending aorta or from the right ventricular infundibulum to the main pulmonary artery. The calves were anticoagulated with heparin to maintain activated clotting times from 150 to 200 s. Four calves were supported for 23, 24, and 50 days in the LVAD studies, and 40 days in the RVAD study. The first calf died due to intrathoracic bleeding associated with sepsis. The second calf was euthanized for a low flow rate less than 2 L/min due to an obstructed inflow with growing pannus. The third and fourth calves were euthanized as scheduled. Renal and hepatic functions remained normal, and plasma free hemoglobin values were less than 8 mg/dL throughout the experiments. The fourth case showed flow rates of 4.83 +/- 0.57 L/min, input power of 6.16 +/- 0.49 W, and the inside temperature of the actuator of 43.5 +/- 0.52 degrees C. The pumps implanted in the fourth calf demonstrated no thrombus formation at the autopsy. These in vivo experiments revealed that the Gyro PI pump can provide adequate flow as an easily implantable, efficient, antithrombogenic, and nonhemolytic centrifugal LVAD or RVAD with miniaturized actuators.

Animals↗

In vitro thrombogenicity testing of artificial organs.

Thromboembolic complications remain as one of the main problems for blood contacting artificial organs such as heart valves, bloodpumps and others. In vitro evaluation of thrombogenesis in prototypes has not previously been part of the standard evaluation of these devices. In comparison to hemolysis testing, evaluation of the thrombogenic potential is more difficult to perform because of the complexity of the blood coagulation system. We present an in vitro testing procedure that allows the accelerated examination of the thrombogenic potential of different types of blood pumps. Additionally, first results are presented that indicate the reliability of the accelerated clotting test for mechanical heart valves. Results for the centrifugal pump BioMedicus and two microaxial pumps have shown typical thrombus formation at locations such as bearings. The results indicate that the accelerated clotting test is an excellent addition to the much more expensive animal testing of artificial organs or assist devices. In vitro testing permits studies of thrombus formation to be performed at an early stage and at low costs and also facilitates a more precise investigation of device areas known to be potential hot spots for thrombus formation.

Animals↗

Flow characteristics and required control algorithm of an implantable centrifugal left ventricular assist device.

As the clinical application of LVADs has increased, attempts have been made to develop smaller, less expensive, more durable and efficient implantable devices using rotary blood pumps. Since chronic circulatory support with implantable continuous-flow LVADs will be established in the near future, we need to determine the flow characteristics through an implantable continuous-flow LVAD. This study describes the flow characteristics through an implantable centrifugal blood pump as a left ventricular assist device (LVAD) to obtain a simple non-invasive algorithm to control its assist flow rate adequately. A prototype of the completely seal-less and pivot bearing-supported centrifugal blood pump was implanted into two calves, bypassing from the left ventricle to the descending aorta. Device motor speed, voltage, current, flow rate, and aortic blood pressure were monitored continuously. The flow patterns revealed forward flow in ventricular systole and backward flow in diastole. As the pump speed increased, an end-diastolic notch became evident in the flow profile. Although the flow rate (Q [l/min]) and rotational speed (R [rpm]) had a linear correlation (Q = 0.0042R - 5.159; r = 0.96), this linearity was altered after the end-diastolic notch was evident. The end-diastolic notch is considered to be a sign of the sucking phenomenon of the centrifugal pump. Also, although the consumed current (I [A]) and flow rate had a linear correlation (I = 0.212Q + 0.29; r = 0.97), this linearity also changed after the end-diastolic notch was evident. Based upon the above findings, we propose a simple algorithm to maintain submaximal flow without inducing sucking. To maintain the submaximal flow rate without measuring flow rate, the sucking point is determined by monitoring consumed current according to gradual increases in voltage.

Algorithms↗

Anatomical consideration for an implantable centrifugal biventricular assist system.

A miniaturized pivot bearing-supported centrifugal blood pump (Gyro PI) has been developed as a long-term biventricular assist system (BiVAS). In this study we determined the anatomical configuration of this system using a bovine model. Under general anesthesia, a left lateral thoracotomy was performed to open the chest. Two Gyro PI-601 pumps for left and right assists were placed in the preperitoneal pocket by a subcostal abdominal incision. The left pump could be placed along the dome of the diaphragm just beneath the apex of the left ventricle. The right pump could be placed next to the left pump. The inlet and outlet ports of both pumps penetrated the diaphragm. The inlet port of the left pump, with a length of 55 mm, was inserted directly into the apex of the left ventricle. A woven Dacron graft (150 mm long, 11 mm inner diameter) was placed between the outlet port of the left pump and the descending aorta. As for the right pump, a 100 mm long and 120 degree angled inflow conduit was placed between the inlet port and the right ventricular infundibulum. The outlet port of the right pump was connected to the main trunk of the pulmonary artery using a 90 mm long, 11 mm inner diameter Dacron graft. We could perform biventricular assistance to confirm the anatomical feasibility of the Gyro implantable centrifugal BiVAS.

Animals↗

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↗

Flow measurement at the pump head of centrifugal pumps: comparison of ultrasonic transit time and ultrasonic Doppler systems.

Determination of blood flow is essential for monitoring rotary blood pumps. However, accurate measurement directly adjacent to the pump housing is difficult because of the highly irregular flow profiles near the fast spinning rotor. Therefore, a specially adapted flow probe based on the ultrasound transit time (USTT) principle was designed to evaluate the flow in centrifugal blood pumps. The probe can be directly mounted at the housing and creates 2 crossed measuring ultrasound beams. The mean value, Qm, of the 2 output signals corresponds to the blood flow and the difference, Qd, correlates to the vorticity of the flow profile in the pump outflow tract. In vitro measurements obtained an accuracy for mean flow values of better than +/-0.6 L/min in extreme working points and for vorticity values even as high as Qd = 3.5 L/min. Because of vorticity, however, the output signal contained considerable noise, and that required the application of a 10 Hz filter. Positioning of the ultrasound (US) beams parallel to the axial direction of the pump was superior to radial positioning. Additional measurement of the flow profile demonstrated that a large vorticity occurred (up to Qd equal to 3.5 L/min), and this vorticity was highly dependent upon the afterload of the pump. In vivo experiments demonstrated the reliability of the method. We concluded that USTT flow measurement can determine blood flow immediately adjacent to the pump housing with sufficient accuracy, and these measurements are superior to those from US-Doppler systems (which cannot handle the vorticity accurately enough) and electromagnetic devices (which lack zero stability).

Blood Flow Velocity↗

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↗

Importance of pressure recovery for the assessment of aortic stenosis by Doppler ultrasound. Role of aortic size, aortic valve area, and direction of the stenotic jet in vitro.

BACKGROUND: Pressure recovery has been shown to occur distal to aortic stenoses in experimental and clinical studies. However, its clinical relevance in this setting has not yet been evaluated. METHODS AND RESULTS: To address the hypothesis that pressure recovery can cause significant differences between Doppler and catheter gradients in aortic stenosis and to examine the effects of aortic size, aortic valve area, and direction of the stenotic jet on these differences, stenoses with valve areas from 0.5 to 1.25 cm2 and aortic diameters from 1.8 to 5.0 cm were studied in a pulsatile flow model. Jets entered the aorta centrally or eccentrically with angles of 15 degrees, 30 degrees, or 45 degrees. Overall, good correlation was found between Doppler and catheter gradients. However, when the various combinations of orifices and aortas were analyzed separately, slopes varied from 1.0 to 1.86, and the Doppler-catheter gradient differences ranged from -2 (small valve area with a large aorta) to 66 mm Hg (80% overestimation by Doppler echocardiography) when the stenosis was moderate and the aorta was small. Mild eccentricity of the jet did not significantly alter the results. However, overestimation by Doppler decreased with increasing jet eccentricity. Finally, differences between Doppler and catheter gradients could be predicted by estimating pressure recovery from Doppler measurements. CONCLUSIONS: Significant pressure recovery can occur in aortic stenosis and can cause differences between Doppler and catheter gradients. These differences may reach clinical relevance, particularly when the stenosis is moderate and the aorta is small and can be predicted from Doppler measurements.

Aorta↗

Numerical study of wall mechanics and fluid dynamics in end-to-side anastomoses and correlation to intimal hyperplasia.

In order to analyse the wall mechanics and the flow dynamics in compliant vascular distal end-to-side anastomoses, computer simulation has been performed. In a model study the effect of compliance mismatch on the wall displacements and on the intramural stresses as well as the influence of wall distensibility on the flow patterns are demonstrated applying two distensible models with different graft elasticity. In addition, the flow in a rigid model simulating a vein graft without adaption of the venous lumen has been investigated. The geometries for these models were obtained from a concurrent experimental study, where the formation of distal anastomotic intimal hyperplasia (DAIH) was studied in untreated and externally stiffened autologous venous grafts in sheep. In the flow study the time-dependent, three-dimensional Navier-Stokes equations describing the motion of an incompressible Newtonian fluid are applied. The vessel wall is modelled using a geometrically non-linear shell structure. In an iteratively coupled approach the transient shell equations and the governing fluid equations are solved numerically using the finite element method. In both compliant models maximum displacement and areas of steep stress gradients are observed in the junction region along the graft-artery intersection. The comparison of the normal deformations and the distribution and magnitude of intramural stress shows quantitative differences. The graft elasticity acts as a regulating factor for the deformability and the stress concentration in the junction area: In the model with high graft-elasticity maximum normal deformation at the side wall is 17%. This is twice as large as in the stiff graft model and maximum principle stress at the inner surface differs by one order of magnitude. The numerical results concerning the flow patterns indicate strongly skewed axial velocity profiles downstream of the junction, large secondary motion, flow separation and recirculation on the artery floor opposite the junction and at the inner wall downstream of the toe. In these regions a correlation between the time-averaged fluid wall shear stress and intimal thickening found in the animal experiment can be observed, whereas the pronounced formation of DAIH at the suture line seems to be mainly dependent on wall mechanical factors such as intramural stress and strain.

Adaptation, Physiological↗

Long-term ventricular wall actuation: can and should it be systematically explored?

Hearts fail because myocardial power fails. Assist, support, or replacement devices fail, at least in part, because their blood-contacting surfaces fail. Mechanical repowering of a failing heart might circumvent these difficulties by preserving a largely healthy endocardium while correcting the basic deficit, power. Any serious consideration of doing this though must confront some difficult requirements. Effective indefinite support must be coupled with preservation or restoration of valve competence, coronary flow, rapid low-impedance refilling and independent left and right pressures; the avoidance of wall coaptation; hardware that fits in the available space; and unless muscle powered, adaptability to a deliverable form of power. Despite earlier intense interest in acute mechanical devices and later empiric study of muscle wraps, little systematic methodical work has been done on elucidating and meeting these practical requirements. Concerted efforts toward developing research tools and techniques for their study and then finding mechanisms to meet them could well yield one or more effective modalities that circumvent a major obstacle to the indefinite mechanical treatment of heart failure.

Animals↗

A physical analog of the failing left ventricle for in vitro studies of mechanical wall actuation.

Mechanical repowering of a failing heart with devices or skeletal muscle could circumvent blood-pump lining problems. Requirements are complex: indefinite support with preservation of valve competence and coronary flow, avoidance of wall coaptation, and allowance of both rapid low impedance refilling and independent left and right pressures. An accurate in vitro physical failing-heart analog could facilitate the choice and screening of surgical and engineering approaches in mock circulation experiments. Prosthetic models, transplant recipient hearts, normal animal hearts, existing in vivo animal failure models, and failing cadaver hearts all have serious limitations. One hundred and four excised porcine hearts were dilated and fixed by three iterative protocols. Geometric and passive mechanical parameters were assessed and compared with targets expected for an end-stage failing heart. For Protocol 3, Subgroup 2 (reinforcing valve support, dilatation by compliant ventricular balloon, and ethyl alcohol fixation), the left ventricular shape and capacity (ellipsoid, 201-377 ml/500 g of heart weight), passive valve function, wall flexural rigidity (Et3 range 0.101-0.331 Nm), and refilling mechanics (99 +/- 17.46 ml during 200-400 ms at < or = 10 mm Hg transmural gradient) were all within goal criteria.

Animals↗

Microspheres based detoxification system: a new method in convective blood purification.

A variety of protein-bound or hydrophobic substances, accumulating as a result of pathologic conditions such as exogenous or endogenous intoxications, are removed poorly by conventional detoxification methods because of low accessibility (hemodialysis), insufficient adsorption capabilities (hemosorption), low efficiency (peritoneal dialysis), or economic limitations (high-volume plasmapheresis). Combining advantages of existing methods with microspheric technology, a module-based system was designed. Major operating parameters of the latter can be modified to allow for adjustment to individual clinical situations. An extracorporeal blood circuit including a plasmafilter is combined with a secondary high-velocity plasma circuit driven by a centrifugal pump. Different microspheric adsorbers can be combined in one circuit or applied in sequence. Thus, a prolonged treatment can be tailored using specially designed selective adsorber materials. Comparing this system with existing methods (high-flux hemodialysis, molecular adsorbent recycling system), results from our in vitro studies and animal experiments demonstrate the superior efficiency of substance removal.

Adsorption↗

Influence of different conditioning methods on force and fatigue resistance in chronically stimulated skeletal muscles.

A study was undertaken to compare different conditioning methods for the transformation of latissimus dorsi muscle into a fatigue resistant one for application in circulatory assist. In ten sheep four electrodes were sutured to the epineurium of the left thoracodorsal nerve for indirect electrical stimulation of the latissimus dorsi muscle. In six sheep a "carousel stimulation," a special multichannel stimulation, in combination with a recently developed conditioning protocol was used for muscle conditioning (multichannel method). In four sheep, a conventional stimulation protocol using single channel stimulation was applied for transformation of the muscle (single channel method). The final experiments were carried out when fatigue resistance was obtained. The maximum tetanic forces at different preloads were determined and fatigue resistance was tested during 20 minutes of continuous stimulation. Both conditioning patterns led to fatigue-free chronic stimulation. Muscles conditioned by multichannel stimulation exhibited between 20% and 33% less force than the contralateral unconditioned muscles, whereas in the single channel group this loss was between 32% and 43%. Thus, the multichannel method revealed relatively superior in preserving muscle force for chronic stimulation.

Animals↗