JP2023039401A - Organ preservation container, organ preservation device, and method for manufacturing organ preservation container - Google Patents

Abstract

To provide a compact lightweight organ preservation container.SOLUTION: An organ preservation container 1 is a container for preserving an organ outside the body. The organ preservation container 1 includes: a housing part 20 including a body part 21 that is recessed downwardly; and a lid 30 that covers an opening of an upper part of the body part 21. The housing part 20 and the lid 30 are individually formed by vacuum molding, thereby obtaining a compact lightweight organ preservation container.SELECTED DRAWING: Figure 1

Description

TECHNICAL FIELD The present invention relates to an organ preservation container for preserving an organ outside the body and a method for manufacturing the organ preservation container.

In organ transplantation surgery such as liver transplantation, after the organ is removed from the donor, it is stored in an organ storage container after performing a flush process to wash the blood vessels in the organ until the organ is transplanted to the recipient. transported by If flushing is performed, the tubing is connected to the organ removed from the donor. Then, the liquid is supplied to the blood vessels in the organ through the tube. This allows the blood in the organ to be discharged. In addition, during transportation, cold preservation in which the organ is immersed in a cooled preservation solution, and perfusion treatment in which liquid such as physiological saline is perfused into blood vessels in the organ may be performed in the organ preservation container.

A conventional device for extracorporeally preserving an organ removed from a donor is described, for example, in US Pat.

JP 2020-90539 A

In Patent Document 1, an organ storage container (organ chamber assembly) for storing an organ has a complicated structure in which the cover and the bottom are made up of many layers of members. Therefore, the organ storage container is large and expensive.

However, in order to arrange the organ storage container around the surgical field when extracting the organ from the donor, it is desirable that the organ storage container be compact and lightweight. Moreover, it is more desirable that it is disposable and inexpensive in view of its use.

The present invention has been made in view of such circumstances, and an object of the present invention is to provide a lightweight organ storage container.

In order to solve the above-mentioned problems, the first invention of the present application is an organ preservation container for preserving organs outside the body, comprising a container having a main body recessed downward, and a lid covering an upper opening of the main body. , wherein the container and the lid are each formed by vacuum forming.

A second invention of the present application is the organ storage container according to the first invention, wherein the container includes the main body recessed downward from the annular upper edge, and a first edge provided around the upper edge. and a portion, wherein the lid has a cover portion that covers an opening in the upper portion of the body portion, and a second edge portion that is provided around the cover portion, and the first edge and the It is matable with the second edge.

A third invention of the present application is the organ storage container according to the second invention, wherein the first edge portion includes a first annular portion extending radially outward from the upper edge of the body portion; and a second annular portion extending radially outward from the upper end of the first tubular portion. The parts include a radially expanding annular third annular portion, a tubular second tubular portion extending upward from the outer peripheral edge of the third annular portion, and a tubular portion extending radially from the upper end of the second tubular portion. an annular fourth annular portion that expands outward, and in a state in which the first edge and the second edge are fitted together, the upper surface of the first annular portion and the lower surface of the third annular portion; Annular contact surfaces on at least one pair of opposing surfaces of the inner peripheral surface of the first tubular portion and the outer peripheral surface of the second tubular portion, and the upper surface of the second annular portion and the lower surface of the fourth annular portion. have

A fourth aspect of the present application is the organ storage container according to any one of the first aspect to the third aspect, wherein each portion of the containing portion and the lid is plate-shaped with a thickness of 5 mm or less.

A fifth invention of the present application is the organ storage container according to any one of the first invention to the fourth invention, wherein the lower surface of the container has a plurality of projections.

A sixth aspect of the present application is the organ storage container according to any one of the first aspect to the fifth aspect, wherein one or more connectors are attached to the storage portion or the lid to allow communication between the inside and the outside of the organ storage container. have

A seventh invention of the present application is an organ preservation apparatus for preserving an organ outside the body, comprising: the organ preservation container according to the sixth invention; , an outer end connected with the liquid supply and an inner end connected with the catheter.

The eighth invention of the present application is the organ preservation apparatus according to the seventh invention, further comprising a drainage collecting unit for collecting the liquid discharged from the organ, the organ preservation container including a plurality of the connectors, The connector further includes a second connector having an outer end connected to the drainage collector.

A ninth invention of the present application is an organ preservation apparatus for preserving an organ outside the body, comprising: the organ preservation container according to the sixth invention; a portion, and the connector includes a third connector connected to the pressure adjustment portion.

A tenth invention of the present application is a method for manufacturing an organ preservation container for preserving an organ outside the body, wherein the organ preservation container comprises a container having a main body recessed downward and an opening at the top of the main body. a lid for covering, wherein the manufacturing process of the housing part and the manufacturing process of the lid are respectively performed by: a) heating and plasticizing a sheet-shaped resin; and b) applying the plasticized resin to a mold. placing and molding the resin by vacuum suction from the inside of the mold; c) cooling and hardening the resin; d) releasing the resin from the mold; ) trimming the resin.

An eleventh invention of the present application is the manufacturing method according to the tenth invention, wherein in the manufacturing process of the housing portion, the surface in contact with the mold is the lower surface of the housing portion.

According to the first to eleventh inventions of the present application, a compact and lightweight organ storage container can be realized.

In particular, according to the second invention of the present application, no other parts are required for fixation. Therefore, it is possible to reduce the cost of fixing parts and to suppress an increase in the weight of the entire organ preservation container.

In particular, according to the third invention of the present application, the organ preservation container can be sealed. Therefore, leakage of the liquid stored inside the organ storage container is suppressed.

In particular, according to the fifth and eleventh inventions of the present application, the projections, which are traces of suction during vacuum forming, do not come into contact with the internal organs accommodated therein. Therefore, it is possible to prevent the protrusions from contacting the organ and placing a burden on the organ.

In particular, according to the sixth invention of the present application, it is possible to supply/discharge liquid or gas to/from the outside through the connector while sealing the inside of the organ preservation container.

In particular, according to the seventh invention of the present application, liquid can be supplied to the organ housed in the organ storage container through the connector while sealing the inside of the organ storage container. Therefore, the perfusion preservation treatment can be performed on the organ while the organ is housed in the organ preservation container.

In particular, according to the eighth invention of the present application, the liquid discharged from the organ stored in the organ preservation container can be discharged to the outside through the connector while the inside of the organ preservation container is hermetically sealed. Therefore, the perfusion preservation treatment can be performed on the organ for a long time while the organ is housed in the organ preservation container.

In particular, according to the ninth invention of the present application, the inside of the organ preservation container can be communicated with the pressure adjustment section through the connector while the inside of the organ preservation container is hermetically sealed. Therefore, the pressure inside the organ storage container can be adjusted while the inside of the organ storage container is hermetically sealed.

1 is a vertical cross-sectional view of an organ storage container according to a first embodiment; FIG. FIG. 4 is a top view of the accommodating portion of the organ storage container according to the first embodiment; Fig. 2 is a top view of the lid of the organ storage container according to the first embodiment; 4 is a photograph showing a state in which a liver is accommodated in the accommodation portion of the organ storage container according to the first embodiment; 4 is a photograph showing a state in which a liver is accommodated in the organ storage container according to the first embodiment; 4 is a photograph showing a state in which a liver is accommodated in the organ storage container according to the first embodiment; 4 is a flow chart showing the flow of the manufacturing process of the organ storage container according to the first embodiment. FIG. 4 is a schematic diagram showing a state of the manufacturing process of the organ storage container according to the first embodiment; FIG. 4 is a schematic diagram showing a state of the manufacturing process of the organ storage container according to the first embodiment; FIG. 4 is a schematic diagram showing a state of the manufacturing process of the organ storage container according to the first embodiment; FIG. 4 is a schematic diagram showing a state of the manufacturing process of the organ storage container according to the first embodiment; 4 is a flow chart showing the flow of organ transplant surgery according to the first embodiment. Fig. 10 is a vertical cross-sectional view of an organ storage container according to a second embodiment; It is the flowchart which showed the flow of the manufacturing process of the organ storage container which concerns on 2nd Embodiment. 4 is a flow chart showing the flow of organ transplantation surgery according to the second embodiment.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described with reference to the drawings.

As used herein, "donors" and "recipients" may be human or non-human animals. That is, in the present application, an "organ" may be either a human organ or a non-human animal organ. Non-human animals may also be rodents, including mice and rats; ungulates, including pigs, goats, and sheep; non-human primates, including chimpanzees; Animals other than animals may be used.

<1. First Embodiment>
<1-1. Configuration of Organ Preservation Container>
FIG. 1 is a vertical cross-sectional view of an organ storage container 1 according to the first embodiment of the present invention. This organ storage container 1 is a container for temporarily storing an organ removed from a donor outside the body during an organ transplant operation until the organ is transplanted to a recipient. Organs preserved in the organ preservation container 1 are, for example, liver, kidney, heart, or pancreas. However, the organ preserved in the organ preservation container 1 may be an organ other than the above, or may be a part of the organ.

As shown in FIG. 1 , the organ storage container 1 of this embodiment has a container 20 and a lid 30 . The housing portion 20 and the lid 30 are each formed by vacuum molding. The housing portion 20 and the lid 30 each have a thickness of 5 mm or less at each portion. Moreover, the organ storage container 1 does not have parts other than the container 20 and the lid 30 . Therefore, the organ storage container 1 is compact and lightweight as compared with conventional heavy organ storage containers.

The storage unit 20 stores the excised organ and a liquid such as a preservation solution. FIG. 2 is a top view of the housing portion 20. FIG. As shown in FIGS. 1 and 2 , the housing portion 20 has a body portion 21 and a first edge portion 22 .

The body portion 21 is a cup-shaped portion recessed downward from an annular upper edge 210 . In this embodiment, the body portion 21 includes a truncated cone-shaped side wall portion 211 that tapers downward from an annular upper edge 210 and a curved bottom portion 212 that protrudes downward from the lower end portion of the side wall portion 211. and

The first edge portion 22 is an annular portion provided around the upper edge 210 of the body portion 21 . The first edge portion 22 has a first annular portion 221 , a first cylindrical portion 222 and a second annular portion 223 . The first annular portion 221 is an annular portion extending radially outward from the upper edge 210 of the body portion 21 . The first tubular portion 222 is a cylindrical portion that extends upward from the outer peripheral edge of the first annular portion 221 . The second annular portion 223 is an annular portion extending radially outward from the upper end of the first cylindrical portion 222 . A connecting portion between the first annular portion 221 and the first tubular portion 222 has a smooth curved surface.

When molding the accommodating portion 20, the lower surface and the outer peripheral surface side of the accommodating portion 20 come into contact with the mold. For this reason, as shown in an enlarged view in FIG. 1, a plurality of convex portions 200 are formed as suction traces on the lower surface and the outer peripheral surface side of the housing portion 20 . If the protrusions 200 were arranged on the upper surface and the inner peripheral surface, the protrusions 200 would come into contact with the organ housed in the housing part 20 and put a burden on the organ. By arranging the protrusions 200 on the lower surface and the outer peripheral surface side in this way, it is possible to suppress the burden on the internal organs due to the protrusions 200 generated during vacuum forming.

The lid 30 covers the upper opening of the body portion 21 of the housing portion 20 . 3 is a top view of the lid 30. FIG. As shown in FIGS. 1 and 3, the lid 30 has a cover portion 31 and a second edge portion 32 .

The cover portion 31 is a portion that covers the upper opening of the body portion 21 of the housing portion 20 . The cover portion 31 has a disc portion 311 , a grip portion 312 and ribs 313 . The disc portion 311 is a disc-shaped portion that spreads flat. Grip portion 312 and rib 313 are formed by a part of disk portion 311 protruding upward. The grip portion 312 is a portion that is gripped by the operator when carrying the lid 30 . The grip portion 312 is provided in the center of the disc portion 311 and protrudes upward from the disc portion 311 . The grip portion 312 has a Y shape extending in three directions from the center when viewed from above. Rib 313 protrudes upward from disc portion 311 and extends in a specific direction along the upper surface of disc portion 311 . The height of the rib 313 is lower than the height of the grip portion 312 . In the flat lid 30 , the strength of the cover portion 31 is improved by the ribs 313 .

The second edge portion 32 is an annular portion provided around the cover portion 31 . The second edge portion 32 has a third annular portion 321 , a second cylindrical portion 322 and a fourth annular portion 323 . The third annular portion 321 is an annular portion that expands in the radial direction. In this embodiment, the outer edge portion of the cover portion 31 serves as the third annular portion 321 . The second tubular portion 322 is a cylindrical portion that extends upward from the outer peripheral edge of the third annular portion 321 . The fourth annular portion 323 is an annular portion extending radially outward from the upper end of the second tubular portion 322 . A connecting portion between the third annular portion 321 and the second tubular portion 322 has a smooth curved surface.

The first edge 22 and the second edge 32 are fittable. That is, the housing portion 20 and the lid 30 can be fixed to each other by fitting the first edge portion 22 and the second edge portion 32 together. By fitting and fixing the housing portion 20 and the lid 30 in this manner, no other parts are required for fixing. Therefore, it is possible to reduce the cost of fixing parts, and to suppress an increase in the weight of the entire organ storage container 1 .

Specifically, in the fitted state of the first edge portion 22 and the second edge portion 32, the upper surface of the first annular portion 221 and the lower surface of the third annular portion 321, the inner peripheral surface of the first cylindrical portion 222 and the The outer peripheral surface of the two cylindrical portions 322 and the upper surface of the second annular portion 223 and the lower surface of the fourth annular portion 323 face each other. Then, the upper surface of the first annular portion 221 and the lower surface of the third annular portion 321, the inner peripheral surface of the first tubular portion 222 and the outer peripheral surface of the second tubular portion 322, the upper surface of the second annular portion 223 and the outer peripheral surface of the second tubular portion 322, and Of the three sets of facing surfaces on the lower surface of the four annular portions 323, at least one set of facing surfaces has an annular contact surface. Therefore, in the fitted state of the first edge portion 22 and the second edge portion 32 , the space inside the organ storage container 1 can be sealed by the accommodating portion 20 and the lid 30 . Therefore, the liquid stored inside the organ storage container 1 is prevented from leaking from the fitting portion between the first edge portion 22 and the second edge portion 32 .

In this embodiment, when fitting the first edge portion 22 and the second edge portion 32 together, the second tubular portion 322 is press-fitted into the first tubular portion 222 . Therefore, at least the inner peripheral surface of the first tubular portion 222 and the outer peripheral surface of the second tubular portion 322 among the three pairs of facing surfaces have annular contact surfaces when they are mated.

FIG. 4 is a photograph showing a state in which a pig liver and liquid are stored in the storage portion 20 of the organ storage container 1. FIG. 5 and 6 are photographs showing a state in which the organ preservation container 1 contains pig liver and liquid. In FIGS. 5 and 6, the lid 30 is fitted to the container 20, and the organ preservation container 1 is hermetically sealed.

In this embodiment, the outer diameter of the body portion 21 of the housing portion 20 (that is, the diameter of the upper edge 210) is approximately 310 mm. Also, the height of the body portion 21 is approximately 50 mm. For this reason, as shown in FIG. 4, the body portion 21 has a size suitable for containing a pig liver. Since pig livers and human livers are similar in size, the organ storage container 1 has a size suitable for accommodating human livers as well.

FIG. 5 shows a state in which the organ preservation container 1 containing the pig liver and liquid is kept horizontal. On the other hand, FIG. 6 shows a state in which the organ storage container 1 containing pig liver and liquid is tilted and the liquid contained therein is in contact with the lid 30 . As shown in FIG. 6, even if the liquid stored inside is in contact with the fitting part of the storage part 20 and the lid 30, the liquid inside does not leak. In other words, it can be seen that the organ storage container 1 is kept sealed by the fitting of the housing portion 20 and the lid 30 .

<1-2. Manufacturing process of organ storage container>
Next, the procedures for manufacturing the organ storage container 1 will be described with reference to FIGS. 7 to 11. FIG. FIG. 7 is a flow chart showing the flow of manufacturing steps for the housing portion 20 and the lid 30 of the organ storage container 1 . 8 to 11 are schematic diagrams showing the state of the manufacturing process of the housing portion 20. FIG. Below, the manufacturing process of the accommodating part 20 is demonstrated. Since the manufacturing process of the lid 30 is substantially the same as the manufacturing process of the housing portion 20, the description thereof is omitted.

As shown in FIG. 8, when manufacturing the housing portion 20, first, a sheet-like resin 9 as a material is prepared and placed on the mold 8 (step S101). At this time, the end of the resin 9 is held by the material holding mechanism 90 . Then, the resin is heated by the heater 7 to be plasticized (step S102). Note that the heater 7 is retracted upward, for example, after the heat treatment.

Note that the resin 9 may be heated and plasticized before being placed in the mold 8 . After that, the plasticized resin 9 may be arranged on the mold 8 . That is, step S102 may be performed before step S101. In that case, in order to suppress deformation of the plasticized resin, it is preferable to heat the material resin in the vicinity of the mold.

The mold 8 has a molding surface 80 for shaping the surface shape of the housing portion 20 on its surface. The mold 8 also has a pressure regulation chamber 81 , a common suction passage 82 and a plurality of individual suction passages 83 inside. The pressure regulation chamber 81 is a space provided inside the mold 8 . The common suction passage 82 is a channel that connects the pressure adjustment chamber 81 and a pressure adjustment mechanism (not shown). A plurality of individual suction passages 83 are flow paths that connect a plurality of suction holes 830 provided in the molding surface 80 and the pressure adjustment chamber 81 .

Then, as shown in FIG. 9, the inside of the mold is vacuum-sucked to mold the resin (step S103). Specifically, the pressure adjustment mechanism sucks the gas inside the pressure adjustment chamber 81 through the common suction passage 82 to reduce the pressure inside the pressure adjustment chamber 81 . As a result, gas between the molding surface 80 of the mold 8 and the resin 9 is sucked through the plurality of suction holes 830 provided on the molding surface 80 . As a result, the resin 9 is sucked onto the molding surface 80 , and the resin 9 is shaped along the molding surface 80 . At this time, a so-called plug assist method, in which a member called a plug is used to press the resin 9 against the mold 8, may be used.

At this time, the mold 8 side becomes the lower surface side of the accommodating portion 20 . As a result, the protrusions 200 that serve as traces of the suction holes 830 are formed on the lower surface and the outer peripheral surface of the housing portion 20 . Therefore, when the organ is accommodated in the accommodation section 20, the protrusion 200 does not come into contact with the organ. Further, the convex portion 200 is not formed on the side of the first edge portion 22 facing the second edge portion 32 . Therefore, when the first edge portion 22 and the second edge portion 32 are fitted together, a gap is generated between the first edge portion 22 and the second edge portion 32 by the convex portion 200 to seal the organ storage container 1 . does not interfere with

In addition, when the lid 30 is molded, the mold side is the upper surface side of the lid 30 . As a result, projections (not shown) that serve as traces of the suction holes are formed on the upper surface and the inner peripheral surface of the lid 30 . Therefore, when the lid 30 is fitted with the organ stored in the storage part 20 , even if the organ storage container 1 tilts and the organ touches the lower surface of the lid 30 , the projection does not contact the organ. In addition, no convex portion is formed on the side of the second edge portion 32 that faces the first edge portion 22 . Therefore, when the first edge portion 22 and the second edge portion 32 are fitted to each other, a gap is generated between the first edge portion 22 and the second edge portion 32 by the convex portion, thereby sealing the organ storage container 1 . does not interfere with

Following step S103, the molded resin 9 is cooled and hardened on the mold 8 (step S104). At this time, for example, cold air is applied from the opposite side of the mold 8 to cool the resin 9 . After the resin 9 is cured, the material holding mechanism 90 moves away from the mold to release the molded resin 9 from the mold 8, as shown in FIG. 10 (step S105). At this time, the pressure adjustment mechanism may increase the pressure in the pressure adjustment chamber 81 through the common suction passage 82 to discharge gas from the suction holes 830 and promote mold release.

Finally, as shown in FIG. 11, the released resin 9 is trimmed to remove unnecessary peripheral portions (step S106). In the example of FIG. 11, by trimming the resin 9 at the ring-shaped cutting position C, the accommodating portion 20 can be obtained.

As described above, the housing portion 20 is formed by the vacuum molding method. The lid 30 is similarly formed. In this way, by using the vacuum molding method, it is possible to mass-produce the thin housing portion 20 and the lid 30 at low cost. Therefore, even if the organ preservation container 1 is used as a disposable, there is little burden.

<1-3. Organ transplant procedure>
Next, a procedure for organ transplant surgery using the organ storage container 1 described above will be described with reference to FIG. 12 . FIG. 12 is a flow chart showing the flow of organ transplant surgery. Hereinafter, a person who performs work related to organ transplant surgery is referred to as a "worker". The operator includes a doctor who is a surgeon, a nurse who assists the doctor, and the like. Moreover, below, the case where an organ is conveyed while being preserved by the simple cooling preservation method will be described.

When performing an organ transplant surgery, an operator prepares the organ storage container 1 in advance. Specifically, the container 20 of the organ storage container 1 is placed around the donor's surgical field (step S201).

When preparation of the organ storage container 1 is completed, the operator extracts the organ from the donor (step S202). Specifically, the operator makes an incision in the donor's abdomen and cuts arteries and veins extending from the organ within the donor's body cavity. Then, the operator takes out the organ with both hands from the body cavity of the donor and stores the organ in the storage section 20 of the organ storage container 1 (step S203).

After that, the operator inserts the pipe for liquid supply into the artery of the organ and inserts the pipe for drainage into the vein of the organ (step S204). The liquid supply pipe is connected to a reservoir in which liquid such as physiological saline is stored. Further, the drainage pipe is connected to a drainage collection tank or the like. At this time, the drainage pipe may not be connected to the organ, and the drainage may be naturally discharged into the container 20 . Also, if there are multiple blood vessels that flow into an organ, the fluid supply pipe may be connected to multiple organs. For example, if the organ is the liver, two feed lines may be connected to the hepatic artery and the portal vein.

After each pipe is connected to the organ, the operator performs a flushing process to wash blood vessels in the organ (step S205). Specifically, the operator opens a clamp provided on the route of the liquid supply pipe. As a result, the liquid is supplied from the reservoir to the blood vessels in the organ through the liquid supply pipe. After circulating through the organs, the fluid is drained through the veins. When a drainage pipe is connected to the vein, the discharged fluid passes through the drainage pipe and heads to the drainage collection tank. Such flushing flushes blood clots and waste products from blood vessels within the organ. Each tubing is then removed from the vessel of the organ.

Subsequently, the worker transports the organ storage container 1 containing the organ to the recipient while preserving the organ by the simple cooling preservation method (step S206). In the case of the simple cold storage method, a low-temperature (for example, 4° C.) liquid such as physiological saline is stored in the storage unit 20, and the organ is immersed in the liquid. Then, the organ storage container 1 is sealed with the lid 30 and transported.

When the organ arrives at the recipient, the operator takes out the organ from the organ storage container 1 and places the organ in the body cavity of the recipient (step S207). Subsequently, the operator anastomoses the artery of the organ and the artery of the recipient, and also anastomoses the vein of the organ and the vein of the recipient (step S208). The operator then closes the recipient's abdomen.

As described above, by using this organ storage container 1, the organ can be handled in the organ storage container 1 from immediately after removal from the donor, through flushing and transportation, to immediately before transplantation to the recipient.

Conventional large and complicated organ storage containers are difficult to place around the donor's surgical field, and other containers such as resin bags (isolation bags) are used from immediately after removal from the donor until the completion of the flushing process. Organs were kept in containers. In that case, the organ must be moved twice before transportation: to the bag after extraction and from the bag to the organ storage container. When moving an organ, the worker's body temperature is transmitted to the organ, and a physical load is applied. For this reason, it is preferable that the number of movements of the organ is small. By using this organ storage container 1, the organ can be handled in the organ storage container 1 from immediately after removal from the donor, through flash processing and transportation, to immediately before transplantation to the recipient, as described above. Therefore, the burden on organs is reduced.

<2. Second Embodiment>
<2-1. Configuration of Organ Preservation Apparatus>
FIG. 13 is a diagram showing the configuration of an organ preservation apparatus 100A including an organ preservation container 1A according to the second embodiment of the present invention. The organ preservation apparatus 100A is an apparatus for temporarily preserving an organ X extracted from a donor outside the body until transplantation to a recipient. In this organ preservation apparatus 100A, the perfusion process is performed while the air pressure around the organ housed in the organ preservation container 1A is set to a negative pressure lower than the atmospheric pressure. As a result, the liquid can be smoothly supplied to the blood vessels in the organ while reducing the burden on the organ.

As shown in FIG. 13, the organ preservation apparatus 100A has an organ preservation container 1A, a liquid supply section 40A, and a pressure adjustment section 50A.

The organ storage container 1A is a container for temporarily storing the organ X removed from a donor outside the body until the organ X is transplanted to the recipient when the organ X is transplanted.

The organ storage container 1A has a container 20A and a lid 30A. The housing portion 20A and the lid 30A are each formed by vacuum molding. The housing portion 20A and the lid 30A each have a thickness of 5 mm or less at each portion. Moreover, the organ storage container 1A does not have parts other than the container 20A and the lid 30A. Therefore, the organ storage container 1A is compact and lightweight as compared with conventional heavy organ storage containers.

The organ storage container 1A is obtained by attaching a plurality of connectors 61A, 62A, 63A, 64A to the organ storage container 1 of the first embodiment. Connectors 61A, 62A, 63A, and 64A are connection members to which pipes can be attached from the inside and outside of the organ storage container 1A. Each of the connectors 61A, 62A, 63A, 64A has a cylindrical channel inside. Accordingly, when piping is attached from the inside and outside of the connectors 61A, 62A, 63A, and 64A, the piping arranged inside the organ storage container 1A and the piping arranged outside can be connected so as to communicate with each other.

In this embodiment, four connectors 61A to 64A are attached to the organ storage container 1A. Specifically, the four connectors 61A, 62A, 63A, and 64A are a first connector 61A and a second connector 62A connected to the liquid supply section 40A, and a third connector 63A and a third connector 63A connected to the pressure adjustment section 50A. 4 connectors 64A.

The four connectors 61A, 62A, 63A, and 64A are attached so as to pass through the organ storage container 1, respectively, and communicate the inside and outside of the organ storage container 1 with each other. As a result, while the inside of the organ storage container 1A is sealed, liquids and gases can be supplied/exhausted to/from the outside of the organ storage container 1A through the connectors 61A, 62A, 63A, and 64A.

A first connector 61A and a second connector 62A are attached to the housing portion 20A. Specifically, the first connector 61A and the second connector 62A are attached so as to pass through the side wall portion 211A of the main body portion 21A of the housing portion 20A. A third connector 63A and a fourth connector 64A are attached to the lid 30A. Specifically, the third connector 63A and the fourth connector 64A are attached so as to vertically penetrate the cover portion 31A of the lid 30A.

One end of the first catheter 65A is connected to the inner end of the first connector 61A. The other end of the first catheter 65A is connected to an inflow blood vessel (for example, an artery) of the organ X housed inside the organ storage container 1A. One end of the second catheter 66A is connected to the inner end of the second connector 62A. The other end of the second catheter 66A is connected to an outflow blood vessel (for example, a vein) of the organ X housed inside the organ storage container 1A.

The liquid supply unit 40A supplies the organ X with a preservation liquid such as physiological saline. The liquid supply section 40A has a liquid storage section 41A, a liquid supply pipe 42A, a liquid discharge pipe 43A, and a liquid discharge recovery section 44A.

The liquid storage part 41A holds a preservation liquid before being supplied to the organ X. The liquid storage part 41A of the present embodiment is a pouch bag (so-called drip bag) in which a preservation liquid is stored. It should be noted that the liquid storage part 41A may be in other forms such as a so-called tank or bottle as long as it is a container capable of storing the storage liquid. The liquid storage part 41A is held at a position higher than the organ X held in the organ storage container 1A by the bag holding part 45A.

The liquid supply pipe 42A is a pipe for supplying preservation liquid from the liquid reservoir 41A to the organ X housed in the organ preservation container 1A. One end of the liquid supply pipe 42A is connected to the liquid reservoir 41A. The other end of the liquid supply pipe 42A is connected to the outer end of the first connector 61A. As a result, the liquid reservoir 41A and the inflow blood vessel of the organ X are connected via the liquid supply tube 42A, the first connector 61A and the first catheter 65A. As a result, the preservation liquid can be supplied to the organ X from the liquid reservoir 41A.

A so-called drip tube (drip chamber) 421A and an on-off valve 422A are interposed in the liquid supply pipe 42A. The on-off valve 422A opens and closes communication of the liquid supply pipe 42A. In addition, the liquid supply pipe 42A does not have to have the drip tube 421A. Also, instead of the on-off valve 422A, a flow rate regulator (roller clamp, clamp) used in a general infusion device may be used.

In this embodiment, no liquid supply pump is provided on the path of the liquid supply pipe 42A. Due to the difference in water head between the liquid reservoir 41A and the organ X, the preservation liquid flows from the liquid reservoir 41A into the organ X through the liquid supply tube 42A, the first connector 61A and the first catheter 65A. In this way, by omitting the liquid supply pump, it is possible to simplify the device configuration and reduce the pressure burden on the organ X due to the inflow of the preservation liquid.

The drainage pipe 43A is a pipe for discharging the liquid discharged from the organ X to the outside of the organ storage container 1A. One end of the drain pipe 43A is connected to the outer end of the second connector 62A. The other end of the drainage pipe 43A is connected to the drainage collection section 44A. As a result, the discharge blood vessel of the organ X is flow-connected to the drainage collection part 44A via the second catheter 66A, the second connector 62A and the drainage tube 43A. As a result, the liquid discharged from the organ X can be recovered to the drainage recovery section 44A.

The drainage recovery unit 44A may be, for example, a mere drainage recovery tank, and may recover drainage from the organ X to the drainage recovery unit 44A due to the head difference. Further, the drainage recovery unit 44A may include a drainage pump and a drainage recovery tank, and may promote drainage from the organ X by the drainage pump.

In the present embodiment, the liquid is recovered from the discharge blood vessel of the organ X to the drainage recovery section 44A via the second catheter 66A, the second connector 62A and the drainage tube 43A. However, the liquid discharged from the organ X into the organ storage container 1A may be collected into the drainage liquid collecting section 44A. Specifically, the other end of the second catheter 66A may not be connected to the organ X and may be arranged near the bottom of the housing portion 20A. By doing so, the liquid discharged from the organ X and accumulated in the storage section 20A can be recovered to the drainage recovery section 44A via the second catheter 66A, the second connector 62A and the drainage tube 43A.

Also, without connecting the second catheter 66A to the second connector 62A, the liquid accumulated in the storage section 20A is recovered to the drainage recovery section 44A via the second connector 62A and the drainage tube 43A. good too. In this case, when the liquid accumulates in the housing portion 20A up to the height of the second connector 62A, the liquid can be discharged through the second connector 62A.

The pressure adjustment unit 50A is arranged outside the organ storage container 1A and adjusts the pressure inside the organ storage container 1A to a predetermined pressure lower than the atmospheric pressure. 50 A of pressure adjustment parts have 51 A of decompression mechanisms, 52 A of pressure measurement parts, and 53 A of control parts.

The decompression mechanism 51A of this embodiment has an intake pipe 511A, a decompression pump 512A, a regulator 513A and an on-off valve 514A.

One end of the intake pipe 511A is connected to the outer end of the third connector 63A. As a result, one end of the suction pipe 511A communicates with the internal space of the organ storage container 1A. The other end of the intake pipe 511A is connected to a decompression pump 512A. The regulator 513A and the on-off valve 514A are connected on the path of the intake pipe 511A.

The regulator 513A boosts the negative pressure generated by the decompression pump 512A to a higher (smaller absolute value in gauge pressure) constant negative pressure. The opening/closing valve 514A switches the intake pipe 511A between a communicating state and a closed state. In addition, instead of the decompression pump 512A, a utility for decompression provided outside the organ storage container 1A may be used.

When the decompression pump 512A is operated, gas is sucked from the internal space of the organ storage container 1A through the suction pipe 511A and discharged to the external space. As a result, the air pressure inside the organ storage container 1A is lowered.

The pressure measuring section 52A measures the pressure inside the organ storage container 1A. The pressure measuring section 52A is connected to the fourth connector 64A.

The control unit 53A controls the decompression mechanism 51A based on the measured value input from the pressure measurement unit 52A. The control unit 53A is configured by, for example, an electronic circuit board or a computer including a processor such as a CPU and a memory such as a RAM. The controller 53A is electrically connected to the decompression pump 512A, the regulator 513A and the on-off valve 514A of the decompression mechanism 51A, and the pressure measurement section 52A. The control unit 53A controls the operation of each unit of the decompression mechanism 51A according to the pressure in the organ storage container 1A measured by the pressure measurement unit 52A, based on a preset program. As a result, the air pressure inside the organ storage container 1A is adjusted.

The pressure adjustment unit 50A maintains the pressure inside the organ storage container 1A at a negative pressure of −10 mmHg or less and −50 mmHg or more with respect to the atmospheric pressure, for example. By setting the pressure in the organ storage container 1A to −10 mmHg or less with respect to the atmospheric pressure, the blood vessels in the organ X are more likely to expand than when the organ X is under the atmospheric pressure, and the liquid supply section 40A is closed. When the preservation solution is supplied to the blood vessels of the organ X, the pressure on the blood vessels is reduced. Therefore, the preservation solution can be smoothly supplied to the blood vessel of the organ X while reducing the burden on the organ X. On the other hand, if the air pressure around the organ X is less than −50 mmHg with respect to the atmospheric pressure, the organ X is likely to develop edema. Therefore, it is preferable that the pressure inside the organ preservation container 1A is -50 mmHg or more relative to the atmospheric pressure.

The pressure adjustment section 50A may have a leak valve for finely adjusting the pressure inside the organ storage container 1A. In that case, the organ storage container 1A may further have a connector, and a leak valve may be connected to the connector.

Thus, the organ storage container 1A according to the second embodiment has the first connector 61A for connecting the pipes (the liquid supply tube 42A and the first catheter 65A) for supplying the liquid to the organ X from inside and outside. . This makes it easy to supply the liquid to the organ X while the organ X is stored in the organ storage container 1A. In particular, since the first connector 61A is arranged in the housing portion 20A, liquid can be supplied to the organ X regardless of whether or not the lid 30A is attached.

The organ storage container 1A has a second connector 62A for connecting from inside and outside a pipe (drainage pipe 43A and second catheter 66A) for discharging the liquid discharged from the organ X to the outside of the organ storage container 1A. have This makes it easy to recover the liquid discharged from the organ X while the organ X is stored in the organ storage container 1A. In particular, since the second connector 62A is arranged in the housing portion 20A, the liquid discharged from the organ X can be recovered regardless of whether or not the lid 30A is attached.

Moreover, since the organ preservation container 1A has the first connector 61A and the second connector 62A, the lid 30A is attached to the container 20A, and the organ X is accommodated in the closed space inside the organ preservation container 1A. , and the liquid discharged from the organ X can be recovered.

Furthermore, the organ storage container 1A has a third connector 63A and a fourth connector 64A that are connected to the pressure adjusting section 50A. Thereby, the pressure inside the organ storage container 1A can be adjusted when the organ X is stored and transported. Therefore, the organ X can be perfused and preserved under a desired pressure environment.

<2-2. Manufacturing process of organ storage container>
Next, the procedure of the manufacturing process of the organ storage container 1A according to the second embodiment will be described with reference to FIG. FIG. 14 is a flow chart showing the flow of the manufacturing process of the housing portion 20A of the organ storage container 1A. The manufacturing process of the lid 30A is substantially the same as the manufacturing process of the housing portion 20A, so the description is omitted.

Steps S301 to S306 shown in FIG. 14 are the same as the manufacturing process of the organ storage container 1 according to the first embodiment shown in FIG. As a result, a member corresponding to the accommodating portion 20 of the organ storage container 1 according to the first embodiment, which does not have through holes for attaching the first connector 61A and the second connector 62A, is formed. Below, the state before the completion of this housing portion 20A is referred to as an incomplete housing portion 20A.

Subsequently, two through holes for attaching the first connector 61A and the second connector 62A are formed in the side wall portion 211A of the main body portion 21A of the formed unfinished accommodating portion 20A (step S307). Then, the first connector 61A is attached to one side of the formed through-hole, and the second connector 62A is attached to the other side (step S308). 20 A of accommodating parts are formed of the above.

In step S308, for example, when the outer peripheral surfaces of the first connector 61A and the second connector 62A are made of a material having a sealing property, the first connector 61A and the second connector 62A are simply inserted into the through holes. may be attached to the main body portion 21A. Also, a member having a sealing property may be interposed between the outer peripheral surfaces of the first connector 61A and the second connector 62A and the edges of the through holes. Alternatively, the outer peripheral surfaces of the first connector 61A and the second connector 62A and the edges of the through holes may be fixed with a sealing adhesive.

As described above, the housing portion 20A is formed by the vacuum forming method. Lid 30A is also formed in the same manner. In this way, by attaching the connectors 61A to 64A after formation using the vacuum forming method, the lightweight connector-equipped organ storage container 1A can be produced in large quantities at low cost. Therefore, even if the organ preservation container 1A is used as a disposable, the burden is small.

<2-3. Organ transplant procedure>
Next, a procedure for organ transplant surgery using the organ storage container 1A according to the second embodiment will be described with reference to FIG. FIG. 15 is a flow chart showing the flow of organ transplant surgery according to the second embodiment. Note that descriptions of points that overlap with the description of the organ transplant surgery according to the first embodiment will be omitted.

When performing an organ transplant operation, an operator prepares the organ storage container 1A in advance. Specifically, the container 20A of the organ storage container 1A is arranged around the surgical field of the donor (step S401).

Specifically, in advance, the first catheter 65A is connected to the inner end of the first connector 61A, the second catheter 66A is connected to the inner end of the second connector 62A, and the outer end of the first connector 61A is connected in advance. The liquid supply pipe 42A of the liquid supply section 40A is connected to the end, and the drain pipe 43A is connected to the outer end of the second connector 62A. At this time, the on-off valve 422A is closed to stop the supply of the preservation liquid from the liquid reservoir 41A to the first catheter 65A.

When preparation of the organ storage container 1 is completed, the operator extracts the organ X from the donor (step S402). Then, the operator takes out the organ X from the body cavity of the donor with both hands and stores the organ X in the storage section 20 of the organ storage container 1 (step S403).

After that, the operator inserts the first catheter 65A, which is a pipe for supplying fluid, into an inflow blood vessel such as an artery of the organ X, and inserts the second catheter 66A, which is a pipe for draining fluid, into a vein of the organ X. It is inserted into the discharge blood vessel (step S404).

After each pipe is connected to the organ, the operator performs a flushing process to wash the blood vessels inside the organ X (step S205). Specifically, the operator releases the on-off valve 422A. As a result, the preservation liquid is supplied from the liquid reservoir 41A to the organ X via the liquid supply tube 42A, the first connector 61A and the first catheter 65A. When the preservation liquid is supplied to the organ X, the liquid circulates in the organ X and is discharged from the discharge blood vessel. That is, the liquid is discharged from the organ X via the second catheter 66A, the second connector 62A, and the drainage tube 43A, and is collected in the drainage recovery section 44A. Blood clots and waste products are washed away from the blood vessels in the organ X by such a flushing process.

Subsequently, the operator carries the organ X to the recipient while perfusing and preserving the organ X (step S406). In this perfusion preservation process, the preservation liquid is continuously supplied by the liquid supply section 40A, and the pressure inside the organ preservation container 1A is adjusted by the pressure adjustment section 50A. Specifically, first, the third connector 63A and the fourth connector 64A are connected in advance to the pressure adjusting section 50A to the containing section 20A containing the organ X to which the preservation liquid is continuously supplied from the liquid supply section 40A. The closed lid 30A is attached to hermetically seal the organ preservation container 1A. After that, the pressure adjustment unit 50A is operated to adjust the pressure inside the organ storage container 1A. Then, the organ storage container 1A is transported together with the liquid supply section 40A and the pressure adjustment section 50A.

When the organ storage container 1A containing the organ X arrives at the recipient, the operator takes out the organ X from the organ storage container 1A and places the organ X in the body cavity of the recipient (step S407). Subsequently, the operator anastomoses the artery of the organ X and the artery of the recipient, and anastomoses the vein of the organ X and the vein of the recipient (step S408). The operator then closes the recipient's abdomen.

As described above, if the organ storage container 1A is used, the organ X can be stored in the organ storage container 1A from immediately after removal from the donor, through transportation accompanied by flushing and perfusion preservation treatment, to immediately before transplantation to the recipient. can handle. Therefore, the burden on the organ X is reduced.

In this embodiment, the organ preservation container 1A has a first connector 61A for supplying preservation liquid from the outside of the organ preservation container 1A to the organ X housed in the organ preservation container 1A. Thereby, the storage solution can be supplied to the organ X housed inside while the lid 30A is attached to the storage part 20A and the organ storage container 1A is sealed. Therefore, even when the organ X is being transported, the organ X can be perfused and preserved.

The organ preservation container 1A also has a second connector 62A for discharging the liquid discharged from the organ X in the organ preservation container 1A to the outside of the organ preservation container 1A. As a result, the liquid discharged from the organ X can be discharged to the outside of the organ storage container 1A while the lid 30A is attached to the storage part 20A and the organ storage container 1A is sealed. When the perfusion preservation treatment is prolonged, the drainage of the liquid becomes essential. By providing the second connector 62A, the organ X can be perfused and preserved for a long time even when the organ X is being transported.

Further, the organ storage container 1A has a third connector 63A and a fourth connector 64A for connecting a pressure adjusting section 50A for adjusting the pressure inside the organ storage container 1A. As a result, the lid 30A is attached to the container 20A, the organ storage container 1A is sealed, and the pressure inside the organ storage container 1A can be adjusted.

<3. Variation>
Although one embodiment of the present invention has been described above, the present invention is not limited to the above embodiment.

In the above-described second embodiment, the organ storage container has connectors to which piping can be attached from the inside and outside of the organ storage container. However, instead of the connector, it may have a through-hole into which the pipe can be inserted without creating a gap. Even in that case, liquid is supplied from the outside of the organ storage container to the organ stored in the organ storage container through the through hole, or liquid discharged from the organ stored in the organ storage container. can be discharged to the outside. That is, the organ can be perfused while it is housed in the organ storage container. Further, the organ storage container may be provided with a through hole for connecting a pressure adjusting mechanism for adjusting the internal pressure of the organ storage container.

In addition, in the above-described second embodiment, the organ storage container includes the first connector connected to the liquid supply section, the second connector connected to the drainage collection section, the third connector connected to the pressure adjustment section, and the fourth connector connected to the pressure adjustment section. Although we had four connectors, the invention is not so limited. The organ storage container may have only a first connector that connects with the liquid supply, or only two connectors, a first connector and a second connector that connects with the drainage collection. Moreover, the organ storage container may have only the third connector connected to the decompression mechanism as a connector connected to the pressure adjusting section.

Moreover, in the above embodiment, the organ storage container 1 has a circular shape when viewed from above, but the present invention is not limited to this. The organ storage container may have other shapes such as elliptical or rectangular when viewed from above.

Also, the elements appearing in the above embodiments and modifications may be appropriately combined as long as there is no contradiction.

1, 1A Organ Preservation Container 8 Mold 20, 20A Storage Part 21, 21A Body Part 22 First Edge 30, 30A Lid 31, 31A Cover Part 32 Second Edge 40A Liquid Supply Part 44A Waste Liquid Recovery Part 50A Pressure Adjustment Part 61A First connector 62A Second connector 63A Third connector 64A Fourth connector 100A Organ storage device 200 Convex part 210 Upper edge 221 First annular part 222 First cylindrical part 223 Second annular part 321 Third annular part 322 Second 2 cylindrical part 323 fourth annular part X organ

Claims (11)

An organ storage container for storing an organ outside the body,
a housing portion having a body portion recessed downward;
a lid that covers the opening in the upper part of the main body;
has
An organ preservation container, wherein the containing portion and the lid are each formed by vacuum molding. The organ storage container according to claim 1,
The accommodation unit is
the main body recessed downward from the annular upper edge;
a first edge provided around the upper edge;
has
The lid is
a cover part that covers the opening in the upper part of the main body part;
a second edge provided around the cover;
has
The organ preservation container, wherein the first edge and the second edge are mateable. The organ storage container according to claim 2,
The first edge is
an annular first annular portion extending radially outward from the upper edge of the main body;
a tubular first tubular portion extending upward from the outer peripheral edge of the first annular portion;
an annular second annular portion extending radially outward from the upper end of the first tubular portion;
has
The second edge is
a radially expanding annular third annular portion;
a tubular second tubular portion extending upward from the outer peripheral edge of the third annular portion;
an annular fourth annular portion extending radially outward from the upper end of the second tubular portion;
has
In the fitted state of the first edge and the second edge,
an upper surface of the first annular portion and a lower surface of the third annular portion;
an inner peripheral surface of the first tubular portion and an outer peripheral surface of the second tubular portion;
an upper surface of the second annular portion and a lower surface of the fourth annular portion;
an organ storage container having annular contact surfaces on at least one pair of opposing surfaces of the . The organ storage container according to any one of claims 1 to 3,
The organ preservation container, wherein each part of the accommodating part and the lid has a plate shape with a thickness of 5 mm or less. The organ storage container according to any one of claims 1 to 3,
An organ preservation container, wherein the lower surface of the storage part has a plurality of protrusions. The organ storage container according to any one of claims 1 to 3,
An organ preservation container having one or a plurality of connectors attached to the accommodating part or the lid and communicating the inside and the outside of the organ preservation container. An organ preservation device for preserving organs outside the body,
the organ storage container according to claim 6;
a liquid supply unit that supplies liquid to the organ;
has
The connector is
An organ preservation device comprising a first connector having an outer end connected to said liquid supply and an inner end connected to a catheter. The organ preservation device according to claim 7,
further comprising a drainage recovery unit for recovering the liquid discharged from the organ,
wherein the organ storage container includes a plurality of the connectors;
The connector is
The organ preservation device further comprising a second connector having an outer end connected to the drainage collector. An organ preservation device for preserving organs outside the body,
the organ storage container according to claim 6;
Having a pressure adjustment unit that adjusts the pressure in the organ storage container to a pressure lower than the atmospheric pressure,
The connector is
An organ preservation device, comprising a third connector connected to the pressure adjustment unit. A method for producing an organ storage container for storing an organ outside the body, comprising:
The organ storage container is
a housing portion having a body portion recessed downward;
a lid that covers the opening in the upper part of the main body;
has
Each of the manufacturing process of the housing part and the manufacturing process of the lid includes:
a) heating and plasticizing a sheet of resin;
b) placing the plasticized resin in a mold and applying vacuum from the inside of the mold to mold the resin;
c) cooling and hardening the resin;
d) releasing the resin from the mold;
e) trimming the resin;
A manufacturing method. The manufacturing method according to claim 10,
A manufacturing method, wherein a surface in contact with the mold is a lower surface of the accommodating portion in the manufacturing process of the accommodating portion.

Images