NORMOTHERMIC PERFUSION DEVICE SUITABLE FOR MAINTAINING A LIVER OR A KIDNEY IN OPTIMAL PHYSIOLOGICAL CONDITIONS

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 (2) and a disposable part (3), wherein the disposable part (3) comprises a container (4) adapted to house a liver or a kidney and a hydraulic circuit (17) comprising at least one first tube (21) that channels a perfusion fluid externally pumped to the container (4) to the liver or kidney, a second tube (22) that channels a vasodilator fluid to the liver or kidney, and wherein the permanent part (2) comprises in an upper portion a relief (13) configured to house, at least, two containers (4) of different dimensions and geometric configurations.

Claims

1. A normothermic perfusion device (1) to maintain in optimal physiological conditions a liver or kidney intended to be transplanted, wherein said device (1) comprises a permanent part (2) and a disposable part (3), wherein: the permanent part (2) comprises: pumps, heating elements and a control system, configured to regulate fluids in a hydraulic circuit (17) and the temperature of said fluids, whether the container (4) houses a liver or a kidney, and the disposable part (3) comprises: a container (4) that in turn comprises: a hydraulic circuit (17) comprising at least one first tube (21) that channels a perfusion fluid externally pumped to the container (4) to the liver or kidney housed in a central portion (5) inside the container (4), a cannula (16) that channels urine or bile outward from the liver or kidney, respectively, to an external reservoir through a first outlet opening in the container (4), characterised in that the central portion (5) comprises a lower section (6) which has a height difference with respect to an upper section (7) and the liver or kidney is arranged between said upper section (7) and the lower section (6), so that the perfusion fluid after circulating through the liver or kidney falls into the lower section (6), said lower section (6) thus acting as a reservoir for perfusion fluid.

2. The perfusion device of claim 1, wherein the lower section (6) is equipped with a base with a smaller surface than the base of the upper section (7), 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 (4) comprises a removable tray (23) adapted to fit into the central portion (5), comprising a lower area (8) intended to house the liver or kidney and equipped with a plurality of openings (15) through which the perfusion liquid falls into the lower section (6).

4. The perfusion device of claim 1, comprising a connection system (26) connected to the inlet of the artery or liver and fluidly communicated to the first tube (21) and to the second tube (22), thus enabling the vasodilator fluid to be introduced directly into the inlet of the artery of the liver or kidney.

5. The perfusion device of claim 1, wherein the container (4) in the central portion (5) comprises at least one ramp (9) located between the lower section (6) and the upper section (7), wherein said ramp (9) comprises holding elements (10) of the tubes (21, 22), wherein the ramp (9) and the holding elements (10) are adapted to guide the tubes (21, 22) to the lower section (6) until desired operating conditions are reached prior to connection of the liver or kidney.

6. The perfusion device of claim 1, wherein the container comprises a second outlet opening in the container (4) located on an opposite side with respect to the first outlet opening, making it easier to position the cannula (16) towards any of the openings (24, 25), thus enabling both right and left kidneys to be housed in a natural position.

7. The perfusion device of claim 1, wherein the hydraulic circuit (17) comprises, at least, one stopcock (21a, 21b) to purge said hydraulic circuit (17) before starting a perfusion.

8. The perfusion device of claim 1, wherein the hydraulic circuit (17) comprises a valve (20) located externally to the container (4) and operatively connected with an external washing tube that channels a washing fluid, so that the valve (20) is adapted to stop the inlet of 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 (4).

9. The perfusion device of claim 1, wherein the permanent part (2) comprises a relief (13) configured to house, at least, two containers (4) of different dimensions and geometric configurations.

10. A method for perfusing a liver or kidney using the perfusion device according to any of the preceding claims, comprising: placing the liver or kidney in the central portion (5) of the container, the liver or kidney being arranged between the lower section (6) and the upper section (7) of said central portion (5); and 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 (6) of the container wherein it is stored, said lower section (6) acting as a reservoir.

11. The method of claim 10, further comprising a preliminary conditioning step which in turn comprises: making use of the holding means (10) and the ramp (9) to guide the first tube (21) that channels the perfusion fluid to the lower section (6) of the container (4) prior to connecting the liver or the kidney until favourable operating conditions are reached.

12. The method of claim 10, further comprising a washing step comprising: by making use of the valve (20), stopping the inlet of the vasodilator fluid from the second tube (22), and introducing a colder washing fluid into said second tube (22), thus enabling the organ to be washed and damage to be prevented in the event of unexpected failure without removing it from the container (4).

Description

DESCRIPTION OF THE DRAWINGS

[0058] As a complement to the description provided and for the purpose of helping to make the features of the invention more readily understandable, in accordance with a practical preferred exemplary embodiment thereof, said description is accompanied by a set of drawings which, by way of illustration and not limitation, represent the following:

[0059] FIG. 1 shows an exploded perspective view of a preferred embodiment, wherein the disposable part and the permanent part are shown separated.

[0060] FIG. 2 shows a top view of a preferred embodiment of the renal container without the lid and without the removable tray, so that the central portion, the ramp and the means for holding the tubes are clearly shown before starting the perfusion.

[0061] FIG. 3 shows a perspective view of a preferred embodiment of the container, wherein a kidney housed in the removable tray, the first tube and the second tube of the hydraulic circuit and the cannula to the ureter are shown.

[0062] FIG. 4 shows a perspective plan view of the preferred embodiment of FIG. 3, wherein the cannula, the renal artery and the hydraulic circuit purge valves are shown.

PREFERRED EMBODIMENT OF THE INVENTION

[0063] FIG. 1 shows an exploded perspective view of the device wherein a normothermic perfusion device (1) to maintain in optimal physiological conditions a kidney or a liver intended to be transplanted is clearly seen, wherein said device (1) comprises a permanent part (2) and a disposable part (3).

[0064] As shown in FIG. 1, the disposable part (3) comprises a container (4) attached to a panel (12).

[0065] In the preferred embodiment of FIG. 1, in an upper portion, the permanent part (2) is equipped with a relief (13) configured to house two containers (4) of different dimensions and geometric configurations, in this case a container (4) intended to house a kidney being illustrated, wherein a liver or kidney would be housed, respectively.

[0066] Likewise, the permanent part (2) comprises, at least, flow pumps, heating elements and a control system configured to regulate flows in a hydraulic circuit (17) as well as temperature conditions, whether it is a liver or a kidney housed inside the container (4); in this preferred embodiment, said container (4) is thus adapted for a kidney.

[0067] In a preferred embodiment, said container (4) is equipped with a lid designed to protect the organ from external environmental conditions.

[0068] FIG. 2 shows a top view of a preferred embodiment of the container (4) in a renal version, without the lid, wherein it is shown that said container (4) comprises an inner central portion (5) which in turn comprises a lower section (6) defining a cavity with respect to an upper section (7).

[0069] Likewise, FIG. 2 shows that, in a preferred embodiment, the container (4) in the central portion (5) comprises at least one ramp (9) located between the lower section (6) and the upper section (7), wherein said ramp (9) comprises holding elements (10) to hold at least one flow tube (21,22) before the kidney is housed.

[0070] In this way, when the device starts pumping the perfusion flow before introducing the kidney, the holding elements (10) on the ramp (9) provide a hold that maintains the first tube (21) and/or the second tube (22) oriented towards the lower portion (6) until the organ is introduced into the container, thus avoiding splashing and foaming in the container. Consequently, the perfusion process is cleaner.

[0071] FIG. 3 shows a perspective view of a preferred embodiment of the container (4), wherein it is shown that the device (1) comprises a removable tray (23) adapted to fit into the central portion (5) inside the container (4), wherein said removable tray (23) comprises a lower area (8) intended for the kidney, and is equipped with a plurality of openings (15).

[0072] Likewise, FIG. 3 further shows a hydraulic circuit (17) comprising a first tube (21) that channels a perfusion fluid externally pumped to the container (4) to the kidney, a second tube (22) that channels a vasodilator fluid to the kidney.

[0073] Additionally, FIG. 3 shows that the device comprises a ureteral cannula (16) that channels urine from the kidney to an external reservoir through a first outlet opening (24) in the container (4).

[0074] Referring now to FIG. 4, a top view of the preferred embodiment described above is shown, wherein the renal artery (18), as well as a urine conveying tube (19) connected to a second opening (25) located on an opposite side with respect to the first outlet opening (24) are more clearly seen, so that the cannula (16) can channel urine from the kidney to the outside through both sides and openings (24, 25), thus enabling both right and left kidneys to be housed in a natural position. The conveyance of unused urine is blocked using “Roberts clamps” to prevent urine from returning to the container (4).

[0075] Furthermore, FIG. 4 further shows how in a preferred embodiment the second tube (22) is connected by means of a connection element (22a) close to the hepatic or renal artery, thus enabling the vasodilator to be introduced very close to the liver or kidney, respectively.

[0076] Additionally, in the preferred embodiment described above, as shown in FIG. 4, the hydraulic circuit (17) comprises two stopcocks (21a, 21b), one for the first tube (21) that channels the perfusion fluid, and another for the second tube (22) that channels a vasodilator, thus preventing air from entering the organ during perfusion.

[0077] Likewise, in a preferred embodiment, the hydraulic circuit (17) comprises a valve (20) located externally to the container (4) and operatively connected with an external washing tube that channels a washing fluid, so that the valve (20) is adapted to stop the inlet of 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.