ES1299457U - Device for transporting extracorporeal membrane oxygenation systems. (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Device for transporting extracorporeal membrane oxygenation systems, characterized in that it is made up of a module (1) that is fixed to the ECMO machine (2), module (1) in which a base (5) on which the ECMO machine (2) rests, and two side pieces (4) in the form of handles, so that at least one of the side pieces (4) is fixed directly to the ECMO machine (2) , where the module (1) presents at least one connection interface capable of supporting accelerations of at least 1G. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

Device for transporting extracorporeal membrane oxygenation systems

TECHNIQUE SECTOR

The present invention refers to a device for the transport by land, sea and air of extracorporeal membrane oxygenation systems, commonly called ECMO ( Extracoroporeai Membrane Oxygenation), and which consist of extracorporeal oxygenation equipment that allows carry out the respiratory function and as well as replace, partially or totally, the cardiac function, while the lungs can remain less active.

The object of the invention is to provide a device that facilitates the transport of these patients who are in a critical situation, whether by stretcher, ambulance, helicopter, plane or ship, to a referral hospital where they can continue their treatment.

More specifically, the invention is a retainer (retainer or hitch in English) that allows the transport of the ECMO machine with a specific and certified anchorage for all means of transport, allowing it to be carried out safely without the need to change the retainer. or machine, thus reducing the risks of errors and accidents for the patient and increasing the safety of the healthcare team that transports them.

BACKGROUND OF THE INVENTION

As is known, the transport of critical patients is a current health need. In this sense, it is not possible to treat all patients in local hospitals since the specialization of medicine requires a complex learning curve and technology that is not available in these hospitals, so that transport to a reference hospital it is often the only chance a patient has of staying alive or being cured.

In this sense, the use of extracorporeal membrane oxygenation (ECMO) systems was confined to the setting of cardiothoracic surgery in the second half of the 20th century.

However, its ability both to oxygenate, as well as to replace, partially or totally, cardiac function has led to its use in pathologies with high mortality. So much so that, in the last ten years, its implementation has grown exponentially, becoming a rescue option in Acute Respiratory Distress Syndrome (ARDS), where ECMO has been associated with a better prognosis in the trial ' STOP' (63% vs 47%; p=0.003).

Similarly, in Cardiogenic Shock (CS), with mortality rates of up to 65.4%, ECMO has been associated with survival rates greater than 42.0% and up to 85.0% in CS as a bridge to heart transplantation. .

Better known is the unfortunate prognosis of cardiorespiratory arrest (CPA), with recently described mortality rates of 89.3% in Europe. The implantation of ECMO in this context has been called “extracorporeal cardiopulmonary resuscitation” (CPR), having presented encouraging results both in intra-hospital and out-of-hospital CPA. ECMO is currently within the recommendations of the ERC (European Resuscitation Council) and its international counterpart.

Finally, in the current COVID pandemic, ECMO has been the last hope of life for thousands of patients and during it hundreds of ECMO patients have been transferred from a local hospital to a reference hospital.

However, the logistics of transporting this equipment is complex and requires a multidisciplinary and specialized approach. This is established by the ELSO (Extracorporeal Life Support Organization), who have designed guidelines for the implementation of said program, as well as a specific training plan in order to acquire skills in this type of assistance and patients.

The equipment required during an ECMO transport is the same as that used in the hospital, however the mere fact of the transfer poses inherent challenges that require careful planning and specific equipment.

The means of transport required for the same patient are usually multiple, from the simplest that travels from an intra-hospital transport stretcher with wheels to a ambulance and another stretcher, to the more complex means that usually require air transport in some of its phases, both by plane and by helicopter, in addition to the transfer by ambulance.

The means of air transport is especially necessary to be able to care for patients far from the large ECMO centers located in large cities or in other regions.

Normally it is urgent to transfer the ECMO equipment to where the patient is, for its subsequent transfer connected to the ECMO machine to the destination hospital.

The safety of the patient and of the ECMO team itself is the primary objective after the acceptance of a potentially subsidiary case of ECMO by the referral center. That is why certified means are necessary for both land and air transport, which comply with current regulations.

However, to date there is no complete certified solution for transporting these ECMO machines and therefore their patients. There are very heavy partial solutions, but most patients are transferred without the ECMO machine being fixed with a specific retainer for the means of transport used, with the consequent risks for the safety of the patient and the ECMO team.

Current regulations establish that for air transport the retainer or retainer has to withstand accelerations of up to 20G for air transport in one of the axes, and up to 10G for land transport.

As indicated, the ECMO machine and the patient require various types of transportation to reach the destination hospital. However, and although there are some restraints for land transport of ECMO machines, there is no complete solution that allows the machine to be fixed to the transport vehicle by means of a certified restraint whatever the means of transport.

In short, current systems mean that the machine cannot travel safely at all type of transport, requiring in any case a change of retainer to change vehicles, with the consequent risks for the patient.

EXPLANATION OF THE INVENTION

The device for transporting extracorporeal membrane oxygenation systems by land, sea and air of the invention fully satisfactorily resolves the aforementioned problem based on a highly effective solution.

Thus, the device of the invention constitutes a complete solution for the transport of ECMO patients and the transfer of these patients.

More specifically, the device of the invention consists of a module or retainer that is fixed to the ECMO equipment, in which three main pieces participate; two side pieces in the form of handles, in which at least one of them is fixed to the ECMO machine, and a base or floor on which the ECMO machine rests or rests.

In this main module, at least one connection interface capable of withstanding accelerations of at least 1 G is coupled. Thus, according to one embodiment of the invention, the device has two types of connection interfaces, a wall side interface certified that supports accelerations of up to 10 G located on one of the side pieces for connecting the device with means of land transport (for example, for ambulance transfer) and another interface for fixing to aeronautical or maritime rails, so that the The assembly of the module and the connection interface to aeronautical or maritime rails supports accelerations of at least 20 G for transfer by plane or helicopter, this second interface being linked to the module.

Optionally, the module carries on one of its side pieces an interface for fixing to a stretcher retainer, an interface that includes 2 types of anchors for patient stretchers with wheels, capable of withstanding accelerations of at least 1-2 G for interhospital transfer and patient transfer devices (valid for most stretchers on the market). This allows a safe and certified transfer of the ECMO patient from the equipment shuttle to the return and admission of the ECMO patient to the destination critical care unit.

To ensure that each of the described interfaces is capable of withstanding the aforementioned accelerations, each one of them has been calculated and designed following aeronautical regulations using FEM models (Finite Element Method). In this sense, the thicknesses and materials of the different elements that participate in the invention guarantee that the device supports the accelerations specified above and that are also required by European and international transport regulations. Thus, the module and the different components of the interfaces preferably have a thickness between 2.5 mm and 10 mm, with tolerances of the order of thousandths of a millimeter.

The claimed device therefore enables all kinds of transfers - land, air and mixed (ambulance, plane, helicopter) - without losing safety at any time, since it eliminates the need to make changes to the support for the patient, the interfaces and/or the ECMO machine during the transport of this type of patient, thus allowing the use of the ECMO machine with a single valid support throughout the journey that this type of patient may require.

DESCRIPTION OF THE DRAWINGS

To complement the description that is going to be made below and in order to help a better understanding of the characteristics of the invention, according to a preferred example of its practical embodiment, a set of drawings is attached as an integral part of said description. where, with an illustrative and non-limiting nature, the following has been represented:

Figure 1.- Shows an exploded perspective view of the device for transporting extracorporeal membrane oxygenation systems of the invention according to a preferred embodiment thereof.

Figure 2.- Shows an exploded perspective view of the device for transporting extracorporeal membrane oxygenation systems of the invention of the previous figure and of the ECMO equipment.

Figure 3.- Shows a perspective view of the device for transporting extracorporeal membrane oxygenation systems on which the ECMO equipment itself is installed, where lateral wall connection interfaces to land means of transport have been represented, interfaces that are They are screwed onto one of the side pieces in the shape of a handle.

Figure 4.- Shows a view in a different perspective of the assembly of figure 3, in which the interface for fastening to the retainer of a stretcher that is arranged on the other side piece in the form of a handle is observed.

Figure 5.- Shows a view of the device of the invention installed on aeronautical or maritime rails, without the ECMO machine installed on it, where the connection interface to said aeronautical or maritime rails is observed.

Figure 6.- Finally, it shows a detail view of the connection between the interface platform for connection to aeronautical or maritime rails and the module, where one of the retractable pistons can be seen in an insertion position in a hole in the plate and an adapter hole attached to one end of a side piece.

PREFERRED EMBODIMENT OF THE INVENTION

In view of the outlined figures, it can be seen how a module (1) that is fixed to the ECMO machine (2) participates in the device for transporting extracorporeal membrane oxygenation systems by land, air and sea. In the embodiment illustrated in the figures outlined, the module (1) is fixed to the ECMO machine (2) through some rigid structures (3) thereof and designed for it.

More specifically, the module (1) has three main parts, two side parts (4) in the form of handles, with a preferred thickness of 8 mm, in which at least one of them (depending on the type of ECMO machine (2)) is bolted directly to the rigid structures (3). As detailed in figures 1 to 4, the side pieces (4) are linked through their free ends to a base (5), on which the ECMO machine (2) rests, by means of adapters ( 6) and sets of screws (7) and nuts (8) self-locking Preferably, the adapters (6) have a thickness of about 5 mm. The base (5), with a preferred thickness of 6 mm, has nylon protectors (9) on the support areas of the ECMO machine (2) and the adapters (6), all as can be seen in figures 1 and 2. These nylon protectors (9) reduce vibrations in the device and therefore in the ECMO machine (2).

By virtue of its own configuration, the side pieces (4) of the module (1) can be reversed in position with respect to each other, allowing the ECMO machine (2) to have its control panel (14) oriented in 2 different directions, increasing the visibility, handling and ergonomics of the transfer and therefore the safety of the patient and the mission.

On the other hand, as can be seen in figures 3 and 4, connection interfaces are screwed onto one of the side pieces (4), which are lateral wall interfaces (10) for joining the device to land means of transport, wall interfaces (10) capable of withstanding acceleration of at least 10 G. The lateral wall interface (10) for land transport is connected to the ambulance wall supports by means of screws or universally to the FERNO® INTRAXX® system, offering the device a structural integrity of at least 10 G as inertial load factor.

Complementarily, on the opposite side piece (4) a connection interface is screwed, which is a fixing interface (11) to the retainer of a stretcher. This fixing interface (11) has two different types of supports, an inverted 'U'-shaped support (12) for one type of stretcher and another square support (13) for another type of stretcher, both supports folding. to reduce incidents if not used. Thus, this fixing interface (11) offers a structural integrity of the device of at least 1 G as an inertial load factor.

Finally, the base (5) is used to connect with the specific connection interface for transport by plane, helicopter or ship. Thus, the connection interface to aeronautical or maritime rails (17) is made up of a platform (15), with a preferred thickness of 4 mm, and at least four retractable pistons (16), or pins, for connection to the main module (1). As can be seen in figures 5 and 6, the platform (15) is attached to the module (1) by means of screws and plates (18), which preferably have a thickness of 3 mm. Specifically, the plates (18) are screwed onto the platform (15), while the retractable pistons (16) are inserted into holes in the plates (18) coinciding with holes in the adapters (6). On the other hand, the platform (15) is fixed to the aeronautical or maritime rails (17) by means of unions (19).

Thus, the assembly of the module (1) and the connection interface to aeronautical or maritime rails (17) is capable of withstanding accelerations of at least 20G, that is, it is capable of withstanding the loads generated in an emergency landing to the case of helicopters and airplanes, and it has been verified by structural calculation applying the following inertial load factors:

- Upper supported acceleration ‘Upward’ = 4 G

- Front supported acceleration ‘Forward’ = 16 G

- Sideward supported acceleration = 8 G

- Lower supported acceleration ‘Downward’ = 20 G

- Rear supported acceleration ‘Backward’ = 1.5 G

Thus, according to the embodiment illustrated in the figures outlined, the module (1) that fixes the ECMO machine (2) is connected to three types of connection interfaces: a wall interface (10) for certified wall-side connection 10 G, shown in figure 2, for the transfer by ambulance; a fixing interface (11), certified 1G, for transfer on stretchers and an interface for connection to aeronautical or maritime rails (17), certified 20G, arranged in the base (5) and anchored in the rails (17). on the floor of ships for maritime transport or on the rails (17) on the floor of aircraft for transport by plane or helicopter.

Regarding the materials used, although other appropriate materials could be used, such as carbon fiber or Titanium 7075, as a purely exemplary way, standard materials from the aeronautical industry such as Aluminum 2024 have been used in the manufacture of the module (1) and the connection interfaces, as well as finishes and surface treatments that allow their use and handling with total safety.

From this structuring described, it is possible to ensure a safe and certified transfer of the patient on ECMO, from the launch of the healthcare team with the ECMO machine to the patient (sending hospital), until the return and admission of the patient on ECMO to the critical care unit of destination (receiving hospital).

The device thus described makes possible, therefore, all kinds of transfers: land, air, sea and mixed (ambulance, plane, helicopter) without losing safety at any time.

Claims (7)

1§.- Device for the transport of extracorporeal membrane oxygenation systems, characterized in that it is made up of a module (1) that is fixed to the ECMO machine (2), module (1) in which a base (5) on which the ECMO machine (2) rests, and two side pieces (4) in the form of handles, so that at least one of the side pieces (4) is fixed directly to the ECMO machine ( 2), where the module (1) presents at least one connection interface capable of supporting accelerations of at least 1G. 2§.- Device for transporting extracorporeal membrane oxygenation systems, according to claim 1§, characterized in that the connection interface is a wall interface (10) that is fixed to at least one of the side pieces (4 ) for connecting the device to means of land transport, so that the wall interface (10) is capable of withstanding accelerations of at least 10 G. 3§.- Device for transporting extracorporeal membrane oxygenation systems, according to claim 1§, characterized in that the connection interface is a fixing interface (11) that is fixed to one of the side pieces (4) for the connection of the device to the retainer of a stretcher, where the fixing interface (11) includes an inverted 'U'-shaped folding support (12) and a square folding support (13), so that the fixing interface (11) It is capable of supporting an acceleration of at least 1G. 4§.- Device for the transport of extracorporeal membrane oxygenation systems, according to claim 1§, characterized in that the connection interface is made up of a platform (15), screws, plates (18) and, at least, four pistons retractable (16), so that the platform (15) is attached to the module (1) by means of the four retractable pistons (16), while the platform (15) is fixed to aeronautical or maritime rails (17), in such a way that the assembly of the module (1) and the connection interface is capable of withstanding accelerations of at least 20 G. 5§.- Device for transporting extracorporeal membrane oxygenation systems, according to claim 1§, characterized in that the side pieces (4) are linked to the base (5) through their free ends by means of adapters (6 ) and screw assemblies (7) and self-locking nuts (8). 6§.- Device for transporting extracorporeal membrane oxygenation systems, according to claim 1§, characterized in that the base (5) has nylon protectors (9) on the support areas of the ECMO machine (2) and of the adapters (6). 7§.- Device for transporting extracorporeal membrane oxygenation systems, according to any of the previous claims, characterized in that the module (1) and the connection interface are made of Aluminum 2024.