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Biomedical subjects

H Reul

Publications and source records attributed to H Reul.

At least 91 records · Page 5Linked to original sources

New J-3 flexible-leaflet polyurethane heart valve prosthesis with improved hydrodynamic performance.

The aim of this new three-leaflet valve development was to design a leaflet with minimum membrane stresses during performance. This is achieved by manufacturing the valve leaflets shaped almost flat in a medium opening position. Thus, the leaflets have two stable positions, one with maximum opening area and the other with favorable stress distribution in the closed position. The transition between the two end positions is achieved through a two-dimensional rolling motion without buckling and with minimum membrane stresses (bulge forces). The manufacturing technique is dip-coating in polyurethane. Hydrodynamic evaluation of the J-3 valve in steady and pulsatile flow showed minimum pressure drop compared to other commercially available valves. Laser-Doppler-anemometry studies indicated very low shear stresses in the flow field downstream of the valve. In durability tests prototypes have reached lifetimes of up to 17 years. In conclusion, the J-3 valve shows superior hydrodynamic performance thereby reducing potential thrombus formation. Minimization of stresses within the valve leaflets through design could reduce calcification.

Biomechanical Phenomena↗

Shear stress related blood damage along the cusp of a tri-leaflet prosthetic valve.

Blood flowing through a prosthetic heart valve can be damaged by flow-induced shear forces. Fluid dynamics variables and geometric factors play an important role in the evaluation of shear-stress-related blood damage. Central-flow prosthetic valves have been considered as an optimal replacement for mechanical and biological valves. Recently it was shown that shear stress distribution along the surface of a polyurethane cusp reaches values that can damage the blood elements. A mathematical model correlating the effects of shear stresses on blood corpuscles with clinical findings was employed in vitro. The model can be applied to the effects of blood-surface interaction and is of clinical relevance.

Blood Cells↗

Closing click of St Jude Medical and Duromedics Edwards bileaflet valves: complaints created by valve noise and their relation to sound pressure and hearing level.

The metallic clicking sound created by mechanical heart valve prostheses frequently bothers patients. To test whether sounds generated by different bileaflet valves correlate to complaints related to the prosthetic clicking 73 patients were investigated after valve replacement with Duromedics Edwards (DE) (n = 38) and St Jude Medical (SJM) (n = 35) valves. The patients were asked about their complaints, sound pressure levels were recorded and audiometry was performed. Sixty-five percent of patients could hear their valve, 18% had sleeping disturbances, 5% felt bothered during daytime and 12% would prefer a less noisy valve. In symptomatic patients, sound pressure levels were higher than in asymptomatic patients (valve audible 45 +/- 8 db(A) vs not audible 39.9 +/- 10 db(A) at 10 cm; P = 0.016). These differences were most apparent in the high frequency bands, corresponding to the metallic click. Symptomatic patients had better hearing and were younger than patients without complaints. Fifty-one percent could hear their valve by conduction through the body, after eliminating air conduction by the use of headsets. The DE prostheses were louder than the SJM valves in general (47.4 +/- 7 vs 39.8 +/- 5 db (A) at 10 cm; P = 0.001) and in each valve position. Patients with DE prostheses had significantly more complaints. The intensity of the closing click of mechanical valves correlates to the complaints caused by prosthetic clicking and thus sound emission should be considered when a mechanical heart valve prosthesis is selected.

Adult↗

[Noise origin and noise-induced complaints after heart valve replacement with mechanical prostheses].

143 patients were investigated in order to determine whether there is a difference in the intensity of the closing click between different mechanical heart valve prostheses. 35 had St. Jude Medical (SJM), 38 Duromedics Edwards (DE), 36 Björk Shiley Monostrut (BSM) and 34 had Carbomedics prostheses implanted. Sound pressure level determined at 1 meter distance was significantly higher for the DE 33.5 +/- 6 dB(A) and BSM 31 +/- 4 dB(A) than for the SJM 24 +/- 4 dB(A) and CM 25 +/- 6 dB(A) prostheses (p = 0.0001). Valves developing higher sound pressures were more frequently audible for the patients (p = 0.0012), caused more sleep disturbances (p = 0.024) and more complaints during daytime (p = 0.07). Significantly more patients carrying such valves wished to have a less noisy valve implanted (0.0047). Symptomatic patients wear louder valves, were younger, had better hearing and were more frequently in sinus rhythm. Valve diameter correlated with the developed sound pressure level. 349 patients answered a questionnaire after valve replacement with DE (256) or BSM (93) prostheses. 5% registered their noise-related complaints as being severe, but more than one third wished to have a less noisy valve implanted. The noise created by the closing click of mechanical prostheses causes significant complaints and this factor should be considered when a mechanical valve is selected.

Adult↗

Cavitation potential of mechanical heart valve prostheses.

Just like technical check valves, the function of mechanical heart valve prostheses may presumably also lead to cavitation effects during valve closure. Due to the waterhammer effect, cavitation may primarily occur in the mitral position leading to high mechanical loading of the valve itself and of corpuscular blood elements. Ten different types of commercial mechanical heart valves were investigated in the mitral position of a pulsatile mock loop, to detect cavitation thresholds under physiologically similar conditions by cinematographic techniques. Almost all these valve prostheses show cavitation up to a ventricular pressure gradient of 5000 mmHg/s. The threshold depends on valve type and size and is sometimes within the physiological range below 2000 mmHg/s. Visible cavitation bubbles with a diameter of up to 1.8 mm and a collapse time of less than 0.1 ms suggest that vapour cavitation may play an important role for material and blood damage in mechanical heart valve prostheses.

Coronary Circulation↗

The geometry of the aortic root in health, at valve disease and after valve replacement.

For the design of aortic valve prostheses with a separation-free flow field and minimum pressure drop the geometry of the aortic root is of high importance, since an appropriate adjustment of the prostheses to the surrounding geometry could largely reduce the risk of thromboembolic complications. For the investigation of the geometry of the aortic root 604 angiographic films out of a total stock of 15,000 of the Medical Clinic I were evaluated. The film material was preclassified into five clinical categories according to the patient's data. For each category characteristic geometries could be derived in non-dimensional form.

Aorta↗

Estimation of turbulent shear stresses in pulsatile flow immediately downstream of two artificial aortic valves in vitro.

Measuring turbulent shear stresses is of major importance in artificial heart valve evaluation. Bi- and unidirectional fluid velocity measurements enable calculation of Reynolds shear stress [formula: see text] and Reynolds normal stress [formula: see text]. tau is important due to the relation to hemolysis and thrombus formation, but sigma is the only obtainable parameter in vivo. Therefore, determination of a correlation factor between tau and sigma is pertinent. In a pulsatile flow model, laser Doppler (LDA) and hot-film (HFA) anemometry were used for simultaneous bi- and unidirectional fluid velocity measurements downstream of a Hall Kaster and a Hancock Porcine aortic valve. Velocities were registered in two flow field locations and at four cardiac outputs. The velocity signals were subjected to analog signal processing prior to digital turbulence analysis, as a basis for calculation of tau and sigma. A correlation factor of 0.5 with a correlation coefficient of 0.97 was found between the maximum Reynolds shear stress and Reynolds normal stress, implying [formula: see text]. In vitro estimation of turbulent shear stresses downstream of artificial aortic valves, based on the axial velocity component alone, seems possible.

Aortic Valve↗

Noise level and perception of the closing click after heart valve replacement with St. Jude Medical and Björk Shiley Monostrut prostheses.

The metallic click generated by the closure of mechanical heart valve prostheses may severely bother patients, but generated sound energy and the extent of complaints after implantation are not known. In 62 patients, after valve replacement with St. Jude Medical (SJM) (n = 35) and Björk Shiley Monostrut (BSM) (n = 27) prostheses, sound energy was recorded with a calibrated noise level analyzer at 5, 10, and 100 cm distance from patients and correlated with their complaints. At a distance of 100 cm, the BSM valves produced a significantly higher sound pressure level, 30.5 +/- 5 db(A), compared to the SJM valves, 24.1 +/- 4 db(A) (p = 0.0001). There was no significant difference at shorter distances. After splitting into frequency bands the highest sound pressure levels were observed in the high frequency ranges (8 to 16 kHz) representing the metallic click. BSM valves produced higher sound levels in all frequency ranges at 1 m distance. Seventy-three percent of all patients were aware of the noise generated by the valve; 20% had disturbed sleep; and 26% preferred a less noisy valve type. Twelve of 27 patients with BSM valves wanted less noisy valves, whereas only 4 of 35 patients with SJM valves wished to have a less noisy valve type (Chi-square p = 0.003). In patients who could hear their valve measured, sound level was higher than in patients who could not. In 9 of 27 patients with BSM (33%), versus 3 of 35 with SJM prostheses (9%), the clicking caused sleep disturbances.(ABSTRACT TRUNCATED AT 250 WORDS)

Acoustics↗

New methods for the development of pneumatic displacement pumps for cardiac assist.

The primary goal of the presented project was to develop a pump family with stroke volumes of 20, 50, 70 and 90 ml, which could be produced at low cost but with sufficient quality. The housing parts of the pump were thermoformed from technical semifinished materials. All blood contacting surfaces of the pump were coated with biomaterials in a controlled dipping process. During the design and fabrication process a professional CAD-system was used. This facilitated spatial presentations of pump components for first evaluations at the initial draft stages. The CAD-design data were then transformed to CNC-controlled lathes and mill's for the fabrication of pump tools. The stresses and strains of the moving blood pump components, such as membranes and valves, were precalculated by means of Finite-Element-Analysis (FEM). After completion of the pump, the internal flow fields were investigated by flow-visualization techniques using non-Newtonian test fluids, and the pump characteristics (function curves) were investigated in appropriate circulatory mock loops. The paper covers all above aspects from first draft to final fabrication and testing.

Biocompatible Materials↗

Estimation of shear stress-related blood damage in heart valve prostheses--in vitro comparison of 25 aortic valves.

The hemodynamics of heart valve prostheses can be reproducibly investigated in vitro within circulatory mock loops. By measuring the downstream velocity and shear stress fields the shear stresses which are clinically responsible for damage to platelets and red blood cells can be determined. The mechanisms of damage and the effects of shear stresses on blood corpuscles were investigated by Wurzinger et al. at the Aerodynamics Institute of the RWTH Aachen. In the present study, the above data are incorporated into a mathematical correlation, which serves as a basic model for the estimation of blood damage. This mathematical model was applied to in vitro investigations of 25 different aortic valve prostheses. The results were compared to clinical findings. In most cases agreement was good, indicating that this model may be directly applied to the clinical situation. This new method facilitates the estimation of clinically expected blood damage from in vitro measurements. It may be useful for the development and evaluation of new valve prostheses. By comparative evaluation of different valve types it also provides additional information to help the implanting surgeon select the optimum valve for his patient.

Aortic Valve↗

Evaluation of mechanical loading of a trileaflet polyurethane blood pump valve by finite element analysis.

The mechanical loading of the leaflets of a polyurethane blood pump valve at closing pressure (max 300 mmHg) and during the opening phase can be numerically calculated by the finite element method. Geometrical and physical non-linearities, supporting forces by neighbouring leaflets and manufacturing-related thickness distribution are taken into account. The valve housing is assumed to be rigid. Volume forces are neglected. The calculations showed that the critical strain limit of 4.5% (long-term failure limit) was exceeded at closing pressure and during valve opening. During valve operation the connection between leaflet and valve housing and the central leaflet region seem to be the critical areas.

Biocompatible Materials↗

In vitro evaluation of left ventricular assistance by cannulation of both femoral arteries.

The possibility of achieving effective mechanical ventricular assistance without the need for thoracotomy provides great clinical advantages. Two in vitro systems were used to assess left ventricular unloading by means of a small-diameter cannula inserted retrograde into the left ventricle by cannulation of the femoral artery. This cannula is connected to the inlet of a centrifugal blood pump (CP) that delivers the blood into the contralateral femoral artery. Steady-flow test circulation was used to pump fluid in a closed loop from a reservoir through the test cannula back into the reservoir. Pressure drops over cannulae with inner diameters of 4, 5, 6, 7, and 8 mm at flows of 2, 2.5, 3 L/min, against a pressure of 60, 80, 100, and 120 mmHg were calculated. A stationary pressure drop of 120 mmHg was measured at a flow of 3 L/min through a 100 cm cannula with an inner diameter of 6 mm. The second system was a pulsatile mock circulation composed of an atrial and an arterial reservoir linked by a pneumatic prosthetic ventricle. This system was coupled with a 100 cm cannula, 6.1 mm inner diameter, which was passed across the outflow valve of the pulsatile prosthetic ventricle and connected to a CP. Fluid was withdrawn from the ventricle and pumped back into the arterial reservoir. Pulsatile pressure drop over the cannula was measured at different CP flows for increasing systolic ventricular pressure; heart unloading was quantified as a function of CP flow under baseline and failing conditions of the prosthetic left ventricle model. At a constant CP flow the pressure drop over the cannula increased with the pulsatility inside the ventricle. The work of the prosthetic ventricle was reduced by more than 50% when the CP pump was set to 3 L/min; at the same flow setting, when the situation of a failing left ventricle was simulated, the CP was able to take over all the work of the prosthetic ventricle, establishing a stationary flow and a 25% higher mean aortic pressure. This approach to left ventricular assistance may have significant clinical relevance.

Assisted Circulation↗

Jamming of prosthetic heart valves by suture trapping: experimental findings.

The vulnerability of the Medtronic-Hall, Björk-Shiley Monostrut, Duromedics, and St. Jude Medical valves to occluder immobilization by sutures was determined under static and pulsatile flow conditions. Variables were cardiac output, cross-sectional diameter of suture, type of suture (braided versus monofilament) and position of the offending suture along the circumference of the valve ring. Under static conditions, pressures, ranging from 40 to 340 mmHg and 10 to 170 mmHg, were required to decompress obstructed Medtronic-Hall and Björk-Shiley Monostrut valves, respectively. As a result of different design characteristics and different occluder/orifice clearances the Medtronic-Hall valve showed its maximum opening pressure in case of interference with sutures at the axis of symmetry in both minor and major orifices, whereas for the Björk-Shiley Monostrut valve this was reached in the minor orifice. Under pulsatile flow conditions, in case of interference with Prolene 2-0 suture, the Duromedics valve showed irregularly delayed opening and an opening pressure difference of 50 mmHg at a cardiac output of 8 L/min, whereas leaflet motion and pressure difference in the St. Jude Medical valve were undisturbed under similar conditions. The necessary pressure difference for opening the Medtronic Hall valve reached 44mmHg at a cardiac output of 8 L/min. High and low risk of extrinsic leaflet obstruction in the Duromedics and St. Jude Medical valves, respectively, is related to the design of the hinge mechanisms and the wedge angle of their leaflets (2 degrees versus 25 degrees). Precautionary principles in implantation of prosthetic heart valves are stressed to prevent the potentially lethal complication of occluder immobilization.(ABSTRACT TRUNCATED AT 250 WORDS)

Equipment Failure↗

An in vitro study of prosthetic heart valve sound.

Patients with an implanted mechanical heart valve sometimes experience the closing sounds of the valve as disturbing. To study the generation of valve sounds in general, a pulse duplicator study was carried out, testing eight commonly used types of prosthetic valves in the aortic position. Pulse rate was set at 70 beats/min, stroke volume at 70 ml and mean 'aortic' pressure at 100 mmHg. Despite the controlled conditions, there was great variability of the closing sound, in both intensity and spectral composition, making noise comparisons and spectral characterization ('sonoprint') difficult. In general, bileaflet mechanical valves produced less noise than did tilting disc valves, particularly those with large opening angles. One small-size (23 mm) tilting disc valve produced 50% less noise than large types. The plastic ball valve, the porcine and the polyurethane trileaflet valve all were very quiet.

Heart Valve Prosthesis↗

[Subjective noise perception and objective measurement of loudness following heart valve replacement with the St. Jude Medical and Duromedics Edwards bileaflet prostheses].

The performance of heart valve prostheses is generally judged by the rate of valve-related complications and the hemodynamic performance. Patients may be severely bothered by the metallic click generated by the closure of the valve. In 74 patients after valve replacement with Duromedics Edwards (DE) (n = 38) and St. Jude Medical (SJM) (n = 36) prostheses the sound energy was recorded and correlated to the complaints of the patients. At a distance of 10 cm the DE valves produced a significantly higher sound pressure with 47 +/- 7 db(A) compared to the SJM valves with 39.8 +/- 5 db(A) (p = 0.001). The noise level was also different for the valves in aortic or mitral position. After splitting into frequency bands the highest sound pressure was observed in the high frequency ranges (8 to 16 kHz) which represents the metallic click. 65% of patients were aware of the noise generated by the valve, 16% had sleep disturbances and 22% would prefer a more silent valve type. 12 of 38 patients with DE valves and 4 of 36 patients with SJM valves wished to have a less noisy valve type (Chi square p = 0.003). In annoyed patients the valves produced a higher sound amplitude of 49 +/- 8 db(A) as compared to undisturbed patients with 42 +/- 6 db(A) (p = 0.002). The noise level of mechanical heart valves should be considered before selection of a prosthesis, because the metallic click bothers patients and the complaints correlate with measured sound energy.

Adult↗

Velocity and shear stress distribution downstream of mechanical heart valves in pulsatile flow.

Ten mechanical valves (TAD 27 mm): Starr-Edwards Silastic Ball, Björk-Shiley Standard, Björk-Shiley Concave-Convex, Björk-Shiley Monostrut, Hall-Kaster (Medtronic-Hall), OmniCarbon, Bicer Val, Sorin, Saint-Jude Medical and Hemex (Duromedics) are investigated in a comparative in vitro study. The velocity and turbulent shear stress profiles of the valves were determined by Laser Doppler anemometry in two different downstream axes within a model aortic root. Depending on the individual valve design, velocity peaks up to 1.5 m/s and turbulent shear stress peaks up to 150 N/m2 were measured during the systolic phase. These shear stress peaks mainly occurred in areas of flow separation and intense momentum exchange. Directly downstream of the valves (measuring axis 0.55.dAorta) turbulent shear stress peaks occurred at peak systole and during the deceleration phase, while in the second measuring axis (1.5.dAorta) turbulence levels were lower. Shear stress levels were high at the borders of the fluid jets. The results are discussed from a fluid-dynamic point of view.

Blood Flow Velocity↗