scholarly journals In-Vitro Biocompatibility and Hemocompatibility Study of New PET Copolyesters Intended for Heart Assist Devices

Polymers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 2857
Author(s):  
Maciej Gawlikowski ◽  
Miroslawa El Fray ◽  
Karolina Janiczak ◽  
Barbara Zawidlak-Węgrzyńska ◽  
Roman Kustosz

(1) Background: The evaluation of ventricular assist devices requires the usage of biocompatible and chemically stable materials. The commonly used polyurethanes are characterized by versatile properties making them well suited for heart prostheses applications, but simultaneously they show low stability in biological environments. (2) Methods: An innovative material-copolymer of poly(ethylene-terephthalate) and dimer linoleic acid—with controlled and reproducible physico-mechanical and biological properties was developed for medical applications. Biocompatibility (cytotoxicity, surface thrombogenicity, hemolysis, and biodegradation) were evaluated. All results were compared to medical grade polyurethane currently used in the extracorporeal heart prostheses. (3) Results: No cytotoxicity was observed and no significant decrease of cells density as well as no cells growth reduction was noticed. Thrombogenicity analysis showed that the investigated copolymers have the thrombogenicity potential similar to medical grade polyurethane. No hemolysis was observed (the hemolytic index was under 2% according to ASTM 756-00 standard). These new materials revealed excellent chemical stability in simulated body fluid during 180 days aging. (4) Conclusions: The biodegradation analysis showed no changes in chemical structure, molecular weight distribution, good thermal stability, and no changes in surface morphology. Investigated copolymers revealed excellent biocompatibility and great potential as materials for blood contacting devices.

Author(s):  
Maciej Gawlikowski ◽  
Miroslawa El Fray ◽  
Karolina Janiczak ◽  
Barbara Zawidlak-Wegrzynska ◽  
Roman Kustosz

(1) Background: The evaluation of ventricular assist devices requires the usage of biocompatible and chemically stable materials. The commonly used polyurethanes are characterized by versatile properties making them well suited for heart prostheses applications but simultaneously they show low stability in biological environment. (2) Methods: An innovative material - copolymer of poly(ethylene-terephthalate) and dimer linoleic acid - with controlled and reproducible physico-mechanical and biological properties was developed for medical applications. Biocompatibility (cytotoxicity, surface thrombogenicity, hemolysis and biodegradation) were evaluated. All results were compared to medical grade polyurethane currently used in the extracorporeal heart prostheses. (3) Results: No cytotoxicity was observed and no significant decrease of cells density as well as no cells growth reduction was noticed. Thrombogenicity analysis showed that the investigated copolymers have the thrombogenicity potential similar to medical grade polyurethane. No hemolysis was observed (the hemolytic index was under 2% according to ASTM 756-00 standard). These new materials revealed excellent chemical stability in simulated body fluid during 180 days ageing. (4) Conclusions: The biodegradation analysis showed no changes in chemical structure, molecular weight distribution, good thermal stability and no changes in surface morphology. Investigated copolymers revealed excellent biocompatibility and great potential as materials for blood contacting devices.


Polymers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 2986
Author(s):  
Roman Major ◽  
Maciej Gawlikowski ◽  
Marek Sanak ◽  
Juergen M. Lackner ◽  
Artur Kapis

Minimizing of the life-threatening thrombo-emboli formation in pulsatile heart assist devices by a new biomimetic heart valve design is presently one of the most important problems in medicine. As part of this work, an original valve structure was proposed intended for pneumatic, extracorporeal ventricular assist devices. The valve design allows for direct integration with other parts of the pulsating blood pump. Strengthening in the form of the titanium or steel frame has been introduced into the polyurethane lagging, which allows for maintaining material continuity and eliminating the risk of blood clotting. The prototype of the valve was made by the injection molding method assisted by numerical simulation of this process. The prototype was introduced into a modified pulsating, extracorporeal heart assist pump ReligaHeart EXT (developed for tilting disc valves) and examined in-vitro using the “artificial patient” model in order to determine hydrodynamic properties of the valve in the environment similar to physiological conditions. Fundamental blood tests, like hemolysis and thrombogenicity have been carried out. Very low backflow through the closed valve was observed despite their slight distortion due to pressure. On the basis of immunofluorescence tests, only slight activation of platelets was found on the inlet valve and slight increased risk of clotting of the outlet valve commissures as a result of poor valve leaflets assembling in the prototype device. No blood hemolysis was observed. Few of the clots formed only in places where the valve surfaces were not smooth enough.


2017 ◽  
Vol 62 (6) ◽  
pp. 623-633 ◽  
Author(s):  
Anastasios Petrou ◽  
Panagiotis Pergantis ◽  
Gregor Ochsner ◽  
Raffael Amacher ◽  
Thomas Krabatsch ◽  
...  

AbstractThe current paper analyzes the performance of a physiological controller for turbodynamic ventricular assist devices (tVADs) during acute patho-physiological events. The numerical model of the human blood circulation implemented on our hybrid mock circulation was extended in order to simulate the Valsalva maneuver (VM) and premature ventricular contractions (PVCs). The performance of an end-diastolic volume (EDV)-based physiological controller for VADs, named preload responsive speed (PRS) controller was evaluated under VM and PVCs. A slow and a fast response of the PRS controller were implemented by using a 3 s moving window, and a beat-to-beat method, respectively, to extract the EDV index. The hemodynamics of a pathological circulation, assisted by a tVAD controlled by the PRS controller were analyzed and compared with a constant speed support case. The results show that the PRS controller prevented suction during the VM with both methods, while with constant speed, this was not the case. On the other hand, the pump flow reduction with the PRS controller led to low aortic pressure, while it remained physiological with the constant speed control. Pump backflow was increased when the moving window was used but it avoided sudden undesirable speed changes, which occurred during PVCs with the beat-to-beat method. In a possible clinical implementation of any physiological controller, the desired performance during frequent clinical acute scenarios should be considered.


2013 ◽  
pp. n/a-n/a ◽  
Author(s):  
Chris H.H. Chan ◽  
Andrew Hilton ◽  
Graham Foster ◽  
Karl M. Hawkins ◽  
Nafiseh Badiei ◽  
...  

2009 ◽  
Vol 30 (2) ◽  
pp. 190-192 ◽  
Author(s):  
Maria D. Hernandez ◽  
Mohammad D. Mansouri ◽  
Saima Aslam ◽  
Barry Zeluff ◽  
Rabih O. Darouiche

We assessed the in vitro antimicrobial activity and the in vivo efficacy of dipping ventricular assist devices in a combination of N-acetylcysteine, gentamicin, and amphotericin B (NAC/G/A). Ventricular assist devices dipped in NAC/G/A exhibited broad-spectrum antimicrobial activity in vitro and were less likely than undipped devices to become colonized with Staphylococcus aureus in a rabbit model.


1994 ◽  
Vol 17 (12) ◽  
pp. 635-642 ◽  
Author(s):  
J.C. Antoranz ◽  
J.F. Del Cañizo ◽  
M.M. Desco

We report on comparative in vitro tests of two ventricular assist devices (VAD) one with a rigid input cannula and the other with a collapsible (compliant) inlet cannula. We show how this compliant cannula yields significant improvements in the hydrodynamic performance of the system.


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