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Nuevo dispositivo de asistencia circulatoria mecánica temporal

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOFR20160111001
Publicado:
09/02/2016
Caducidad:
09/02/2017
Resumen:
Una start-up francesa ha desarrollado un nuevo dispositivo médico de fácil manejo, compacto y portátil que garantiza la regulación del flujo sanguíneo y las funciones vitales del corazón durante operaciones quirúrgicas y eventos cardiovasculares adversos (infarto, insuficiencia cardíaca, miocarditis, etc.) o enfermedades serias y deletéreas del corazón y otros órganos. Este dispositivo supone un avance tecnológico en cuidados intensivos y cirugía gracias a su tamaño, rendimiento clínico y coste, siendo asequible para muchos centros médicos y unidades médicas móviles. La empresa busca un fabricante de dispositivos médicos con el fin de establecer acuerdos de fabricación, licencia o comercialización con asistencia técnica.


Details

Tittle:
New Temporary Mechanical Circulatory Assist Device
Summary:
A start-up company based in central France has developed an innovative, user-friendly, compact and mobile medical device which ensures the blood regulation and heart´s vital functions during surgery but also during adverse cardiac events or serious and deleterious diseases of the heart or other organs.
This start-up is looking for a medical device manufacturer for a manufacturing or licence agreement and/or a commercial agreement with technical assistance
Description:
This French start-up was created under the initiative of a medical doctor with a long background and experience in anesthesia and intensive care who has also been associated to the development of the artificial heart.

A new medical device has been developed which is user-friendly, mobile and which can fit in a basic suitcase. It ensures the blood regulation and the vital functions of the heart, during surgery but also during adverse cardiac events (heart attack, heart failure, myocarditis...) or serious and deleterious diseases of the heart or other organs.
Such events can occur at all times of the life children or adults, during severe conditions on a temporary basis, or when all vital functions are severely threatened on all accident sites. In France only, it is estimated that more than 250 000 people could be saved by using this medical device.

This so-called Temporary Mechanical Circulatory Assist Device (TMCAD) provides a support to blood circulation which can be assimilated to an artificial heart. It represents a real technology breakthrough in intensive care and surgery due to its size, its clinical performances and also its cost making it affordable for many health care centres or mobile medical units (like paramedics).

In case of failure of the heart muscle (in case of myocardial infarction, for example), it is necessary to temporarily substitute the pumping function of deficient cardiac muscle by a mechanical circulatory support system.

Among the circulatory support systems currently used extracorporeal circulation devices are known for short-cutting the failing heart using a servo pump placed outside the body, which receives the blood from cellar veins and reinjected it at the aorta, to mechanically generate a continuous blood flow compatible with the vital needs of the body.

While these systems have demonstrated their effectiveness in their conventional circulatory support functions, they are not satisfactory:
- no possible modularity depending on the condition being treated, only one implementation rightside heart / leftside heart is offered.
- The integration of an external oxygenation may be mandatory.
- The components of these assistance systems are sterile, pre-assembled and pre-packaged.Because of this type of assembly, possible modularity patient and / or pathology remains limited.
- The implementation of these devices is complex. It requires major surgery in an operating theater, surrounded by specialized human resources that are only found in large hospitals which have an advanced technical platform.
- Implementation and monitoring have the same constraints as above. The floor space requirement is very important.
- The purchase price is very high.
- The possibility of mechanical stress on the blood formed elements (e.g. red blood cells) suggests a non-negligible risk of hemolysis.
- Blood flow generated is limited.
- The enslavement of the generated blood flow does not take into account the physiology of the patient.

The present invention overcomes many of the current shortcomings. It aims in particular to allow a flexible implementation according to the failure of the generating function of blood flow, an oxygenation system is not necessarily integrated with the object of the invention device.

It is composed by two different modules or components. (See the functional block diagram attached).
- A motor and a controller to electronically drive the motor.
- A disposable module specific to each patient, consisting of a dynamic reservoir operated by the motor and acting as a pump, a
tubing set connected to the reservoir by a specific innovative connection, invented by the company, 2 canulae specially developed - a venous femoral canula and an arterial femoral canula allowing a back perfusion of the lower limbs, in order to avoid the risk of ischemia;
- Standard products from the market: an optional oxygenator depending on the TMCAD mode either ´supplement´ or ´assist´
Advantages and Innovations:
This device is a real technological breakthrough aiming at being more effective than existing systems for extracorporeal circulation as it uniquely provides the following functional features:
It generates a pulsatile flow (as does the heart), not a continuous flow as do existing system.
- It is connected through a femoral arterio-venous percutaneous canulation preventing the surgical open thorax access or others (example of cardiac surgery)
- It self-regulates, in real-time, the pulsatile blood flow (pressure, volume, and rate), according to the behaviour of the cardiac patient;

- Two functional modes are available:
1°The supplement mode when the heart is weakening
2° The assist mode when the heart stops
The switching from one mode to the other is automatically ensured.
-Its portability and mobility allows the medical transportation of severe cardiac failure patients
- Its setting up does not necessitate an specialized staff and can therefore be used in any hospital resuscitation unit.
Stage of Development:
Prototype available for demonstration
IPs:
Secret Know-how
CommeR Statunts Regarding IPR Status:
A French Patent exists for French market only.
But the core of the system is a secret know-how - the regulatory driving system

Partner sought

Type and Role of Partner Sought:
Type : Industry with preferably international market, a
manufacturer in the fields of micromechanics, electronics with sales, marketing experience applied to the medical sector and ideally a commercial network in hospitals -Y- other edical centers.

Role : Manufacturing under licence of know-how
(Exclusive licence possible against advance of royalties). Option: distribute the equipment through its network.

Client

Type and Size of Client:
Industry SME <= 10
Already Engaged in Trans-National Cooperation:
No
Languages Spoken:
English
French

Keywords

Technology Keywords:
06001011 Enfermedades circulatorias y del corazón
06001007 Medicina de urgencias