US-12616194-B2 - Normothermic perfusion device suitable for maintaining a liver or a kidney in optimal physiological conditions

US12616194B2US 12616194 B2US12616194 B2US 12616194B2US-12616194-B2

Abstract

The present invention relates to a normothermic perfusion device to maintain optimal physiological conditions for both a liver and a kidney intended to be transplanted, comprising a permanent part and a disposable part, wherein the disposable part comprises a container adapted to house a liver or a kidney and a hydraulic circuit comprising at least one first tube that channels a perfusion fluid externally pumped to the container to the liver or kidney, a second tube that channels a vasodilator fluid to the liver or kidney, and wherein the permanent part comprises in an upper portion a relief configured to house, at least, two containers of different dimensions and geometric configurations.

Inventors

PEDRO MOREO CALVO
Victor ALASTRUÉ VERA
Fernando USÓN JULIÁN
JAVIER CONTE BLASCO
MARTA MAINAR LÓPEZ

Assignees

EBERS MEDICAL TECHNOLOGY, S.L.

Dates

Publication Date: 20260505
Application Date: 20210426
Priority Date: 20200424

Claims (11)

1 . A normothermic perfusion device to maintain in optimal physiological conditions a liver or kidney intended to be transplanted, wherein said device comprises a permanent part and a disposable part, wherein: the permanent part comprises: pumps, heating elements, and a controller, configured to regulate fluids in a hydraulic circuit and the temperature of said fluids, whether the container houses a liver or a kidney, the disposable part comprises: a container that in turn comprises: the hydraulic circuit comprising one first tube that channels a perfusion fluid externally pumped to the container to the liver or kidney housed in a central portion inside the container, and a second tube that channels a vasodilator fluid, and a cannula that channels urine or bile outward from the liver or kidney, respectively, to an external reservoir through a first outlet opening in the container, wherein the central portion comprises a lower section which has a height difference with respect to an upper section and the liver or kidney is arranged between said upper section and the lower section, so that the perfusion fluid after circulating through the liver or kidney falls into the lower section, said lower section thus acting as a reservoir for perfusion fluid, and connector which is connected combining the first tube and to the second tube right at the inlet of the artery of the liver or kidney, thus enabling the vasodilator fluid to be introduced directly into the artery.
2 . The perfusion device of claim 1 , wherein the lower section is equipped with a base with a smaller surface than the base of the upper section, thus preventing the perfusion fluid in contact with the air from deteriorating due to contact with the same.
3 . The perfusion device of claim 1 , wherein the container comprises a removable tray adapted to fit into the central portion, comprising a lower area intended to house the liver or kidney and equipped with a plurality of openings through which the perfusion liquid falls into the lower section.
4 . The perfusion device of claim 1 , wherein the container in the central portion comprises at least one ramp located between the lower section and the upper section, wherein said ramp comprises holders of the tubes, wherein the ramp and the holders are adapted to guide the tubes to the lower section until desired operating conditions are reached prior to connection of the liver or kidney.
5 . The perfusion device of claim 1 , wherein the container comprises a second outlet opening in the container located on an opposite side with respect to the first outlet opening, making it easier to position the cannula towards any of the openings, thus enabling both right and left kidneys to be housed in a natural position.
6 . The perfusion device of claim 1 , wherein the hydraulic circuit comprises, at least, one stopcock to purge said hydraulic circuit before starting a perfusion.
7 . The perfusion device of claim 1 , wherein the hydraulic circuit comprises a valve located externally to the container and operatively connected with an external washing tube that channels a washing fluid, so that the valve is adapted to stop an inlet of the vasodilator fluid and enable the inlet of the washing fluid, thus enabling the liver or kidney to be washed without the need to remove it from the container.
8 . The perfusion device of claim 1 , wherein the permanent part comprises a relief configured to house, at least, two containers of different dimensions and geometric configurations.
9 . A method for perfusing a liver or kidney carried out in a normothermic perfusion device comprising a permanent part and a disposable part, wherein: the permanent part comprises: pumps, heating elements, and a controller, configured to regulate fluids in a hydraulic circuit and the temperature of said fluids, whether the container houses a liver or a kidney, the disposable part comprises: a container that in turn comprises: the hydraulic circuit comprising one first tube that channels a perfusion fluid externally pumped to the container to the liver or kidney housed in a central portion inside the container, and a second tube that channels a vasodilator fluid, and a cannula that channels urine or bile outward from the liver or kidney, respectively, to an external reservoir through a first outlet opening in the container, wherein the central portion comprises a lower section which has a height difference with respect to an upper section and the liver or kidney is arranged between said upper section and the lower section, so that the perfusion fluid after circulating through the liver or kidney falls into the lower section, said lower section thus acting as a reservoir for perfusion fluid, and a connector is connected combining the first tube and the second tube right at the inlet of the artery of the liver or kidney, thus enabling the vasodilator fluid to be introduced directly into the artery; and wherein the method comprises the following steps: placing the liver or kidney in the central portion of the container, the liver or kidney being arranged between the lower section and the upper section of said central portion; fluidly connecting the perfusion fluid to the vascular inlets of the liver or kidney, in such a way that after circulating through the liver or kidney the perfusion fluid leaves the same and falls into the lower section of the container wherein it is stored, said lower section acting as a reservoir, and introducing a vasodilator fluid right at the inlet of the artery of the organ to be perfused.
10 . The method of claim 9 , further comprising a preliminary conditioning step which in turn comprises a step of: guiding the first tube that channels the perfusion fluid to the lower section of the container prior to connecting the liver or the kidney until favourable operating conditions are reached.
11 . The method of claim 10 , further comprising a washing step which in turn comprises a step of: stopping the inlet of the vasodilator fluid from the second tube, and introducing a colder washing fluid into said second tube, thus enabling the organ to be washed and damage to be prevented in the event of unexpected failure without removing it from the container.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS AND PRIORITY This patent application claims priority from PCT Application No. PCT/ES2021/070278 filed Apr. 26, 2021, which claims priority from Spanish Patent Application No. P202030343 filed Apr. 24, 2020. Each of these patent applications are herein incorporated by reference in their entirety. OBJECT OF THE INVENTION The present invention relates to a normothermic perfusion device to maintain in optimal physiological conditions a liver or a kidney intended to be transplanted. More particularly, the present invention describes a device comprising a permanent part and a disposable part, wherein the disposable part comprises a container adapted to house a liver or a kidney, and said container in turn comprises a hydraulic circuit to channel a perfusion medium and a vasodilator to the liver or kidney, and the permanent part comprises pumps, heating elements, a controller configured to regulate the conditions of the fluids in the hydraulic circuit, and further comprises in an upper portion a relief adapted to house and fit the disposable part, so that the same device can perform normothermic perfusion of both a liver and a kidney. BACKGROUND OF THE INVENTION Normothermic perfusion devices of a liver or for the kidney are known in the state of the art. However, the devices known in the state of the art are not compatible with the perfusion of the liver and kidney and, consequently, it is necessary to use two different machines to perfuse each one of the organs. Likewise, known devices cause splashes in the perfusion process, in addition to a significant risk of contamination during liver or kidney washing, since it is necessary to open the lid of the container to proceed with washing once the perfusion process is completed. Furthermore, in the known state of the art, the hydraulic circuit can contain air bubbles that can enter the organ, which entails a serious drawback for the perfusion of said organ. For example, document WO2016/090498A1 discloses a normothermic perfusion device for a liver or a kidney intended to be transplanted comprising a permanent part, a container, a hydraulic circuit comprising a first tube that channels a perfusion fluid externally pumped to the container and a cannula that channels urine or bile outward from the liver or kidney respectively, to an external reservoir. DESCRIPTION OF THE INVENTION The present invention seeks to solve some of the problems mentioned in the state of the art. More specifically, the present invention describes a normothermic perfusion device to maintain in optimal physiological conditions a liver or a kidney intended to be transplanted, wherein said device comprises a permanent part and a disposable part, wherein: the permanent part comprises: pumps, heating elements and a control system, configured to regulate fluids in a hydraulic circuit and the temperature of said fluids, whether the container houses a liver or a kidney; and the disposable part comprises: a container that in turn comprises: a hydraulic circuit comprising a first tube that channels a perfusion fluid externally pumped to the container to the liver or kidney housed in a central portion inside the container,a cannula that channels urine or bile outward from the liver or kidney, respectively, to an external reservoir through a first outlet opening in the container, wherein the central portion comprises a lower section having a height difference with respect to an upper section and the liver or kidney is arranged between said upper section and the lower section, so that the perfusion fluid after circulating through the liver or the kidney falls into the lower section, said lower section thus acting as a reservoir for perfusion fluid. Preferably, the permanent part comprises a relief configured to house, at least, two containers of different dimensions and geometric configurations. The aforementioned device is compatible with both a liver and a kidney, since the disposable part varies the dimensions thereof to house any of these organs, both being configured to fit into the relief of the permanent part. Likewise, the permanent part can be reused after each perfusion, and it is configured to control the flow and temperature conditions of the hydraulic circuit, so that the organ inside the disposable part is maintained in a state similar to the physiological state throughout the entire process, said physiological states being different for each organ. Consequently, the same device can be used for both organs (liver or kidney) and there is no need to have two separate machines to perfuse each organ. In a preferred embodiment, the lower section is equipped with a base with a smaller surface than the base of the upper section, thus preventing the perfusion fluid in contact with the air from deteriorating due to contact with the same. Since the horizontal section of the base of the lower section is the contact area between