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Friday, 23 October 2015 13:25

PULSAMED. Pulsatile extracorporeal circulation system Featured

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Juan Manuel Belda Lois*; Luis Prieto Gil; Carlos Atienza Vicente*; José Luis Peris Serra*; Francisco Matey González; Ramón Moraga Maestre; David Moro Pérez; Salvador Mercé Vives**

Instituto de Biomecánica (IBV)
Universitat Politècnica de València
Camino de Vera s/n. Edificio 9C
46022 Valencia, Spain

*The IBV Health Technology Group, Bio-engineering, Biomaterials and Nanomedicine CIBER (CIBER-BBN)

**Mercé Electromedicina, S.L.

The company Mercé Electromedicina, S.L., with the collaboration of the Instituto de Biomecánica (IBV) has developed a system capable of modifying the lineal flow of a conventional heart pump, and of converting it into a pulsatile flow. Among the most outstanding features of this system, known as PULSAMED, are its low cost and the fact that it makes it possible to choose pulse-related energy independently from the blood flow you choose. The maximum values reached by pulse-related energy quadruple those found in scientific literature.

 

 

INTRODUCTION

When performing heart surgery or in situations involving serious cardiac disorders, it is often necessary to substitute or to complement the function of the heart by means of an external system. When blood is made to circulate by means of a system that is external to the patient’s organism, this is known as Cardiopulmonary Bypass (CPB) extracorporeal circulation.

Extracorporeal circulation systems include a system that drives the blood, a cardiac pump, an oxygenator system that supplants the lungs and a heating system to control the temperature of the blood.

In the vast majority of systems used today, blood flow is continuous, with slight variations hardly any variations in the flow rate. This type of circulation differs greatly from the physiological system, where the contractions of the heart produce a pulsatile flow. The pulsatility of the flow allows the blood to reach even the finest vessels, thus improving perfusion in organs such as the brain or the kidneys.

For all these reasons, Mercé Electromedicina, a company dedicated to marketing electro-medical equipment of high technological value and determined from its outset to come up with I+D solutions that serve the patient, has developed with IBV a system that is able to modify the lineal flow of a conventional heart pump and to turn it into a pulsatile flow.

DEVELOPMENT

The project has comprised the design and manufacture of an electro-pneumatic device akin to a ventricle that makes it possible to alter the conditions of a conventional continuous flow from a heart pump and to turn it into an alternating flow.

The project consisted of different stages; in the first stage, different design alternatives were put forward (Figure 1) one of which was finally chosen, given that it satisfied the project’s medical, safety and financial criteria.

 

Figure 1. Conceptual design of the operation of the PULSAMED system. The system's design includes a conventional heart pump and oxygenator. The developed ventricle was placed behind them We placed the ventricle we had developed behind them. By adding a pneumatic system, produces flow pulses by filling and emptying the ventricle.

After evaluating different design and redesign proposals, we produced a final design for a pulsatile pump with a double membrane and an intermediate cavity filled with a saline solution that acts as a safety element by preventing the gas used to create the pulsations from entering into contact with the blood, even in the event of a breakdown (Figure 2).

The system we developed makes it possible to effectively decouple the pulse related energy from the blood flow. The pulse related energy may be chosen by regulating the pressure of the gas used to drive it. The blood flow is adjusted by means of the conventional pump that is incorporated in the circuit. In this way, the perfusionist is at all times able to adapt the pulse energy to the physiological parameters of the patient.

 

 

Figure 2Transversal section of the system we developed, showing the intermediate cavity that makes it possible to decouple the pneumatic part from the part that corresponds to the impulsion of the blood.

 

The quality of the pulse generated is normally measured by the additional pulse related energy (Surplus Hemodynamic Energy: SHE). The highest values one finds in a commercial pulsatile system today achieve a SHE of 20,000 erg. During the project we validated the quality of the system developed by means of an “in vitro” circuit that makes it possible to perform tests, simulating the patient, the oxygenator, the pump, the prototype of the pulsatile pump and all the control elements (Figure 3a), for different combinations of gas pressure and blood flow. During the tests performed in the simulator, we were able to calibrate pulses with SHE of up to 80,000 erg, which practically quadruples the values obtained by previous pulsating heart pumps (Figure 3b).

(A)(B)

Figure 3. A: System prototype. B: Quality of the pulse obtained by the prototype depending on the blood flow and the pulsation pressure.

CONCLUSIONS

♦ We have developed a low cost system that makes it possible to transform a conventional continuous flow into a pulsatile flow.

♦ Pulse related energy may be calibrated independently from the blood flow generated in a simulator.

♦ The maximum values of flow quality achieved quadruple previous values found in scientific literature.

ACKNOWLEDGMENTS

This project, with Reference No. IDI-20120745, has been supported by the Centro para el Desarrollo Tecnológico Industrial (CDTI - Centre for Industrial Technological Development). It has been co-financed by the European Regional Development Fund through its I+D+I Operational Program for the benefit of companies  - Technological Fund.

Our most sincere thanks to the company MERCÉ V. ELECTROMEDICINA, S.L. which entrusted the development of the pump to IBV.

 

 

 

Read 7730 times Last modified on Tuesday, 08 November 2016 17:35



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