WO2020059413A1

WO2020059413A1 - Organ accommodation pouch and transplantation method

Info

Publication number: WO2020059413A1
Application number: PCT/JP2019/032883
Authority: WO
Inventors: 英司小林; 真司虎井; 周平吉本
Original assignee: 株式会社Ｓｃｒｅｅｎホールディングス
Priority date: 2018-09-21
Filing date: 2019-08-22
Publication date: 2020-03-26
Also published as: JP2020044287A; JP7143167B2

Abstract

This organ accommodation pouch (1) is provided with a pouch-shaped insulating sheet (10) that retains an organ (9). The insulating sheet (10) comprises a pair of waterproof layers and an insulating layer located between the pair of waterproof layers. During transplantation surgery for the organ (9), the organ (9) is placed within a body cavity of a recipient while accommodated in the organ accommodation pouch (1). Because of this, blood vessel anastomosis can be performed while elevation of the temperature of the organ (9) due to the body temperature of the recipient and the outside air temperature is suppressed. As a result, the organ is prevented from entering an ischemic state, and thus post-surgery failure can be suppressed. Moreover, because the insulating sheet is pouch-shaped, an end section of the insulating sheet is not prone to obstructing work by a surgeon.

Description

Organ storage bag and transplantation method

{Circle over (1)} The present invention relates to an organ storage bag for storing an organ, and a transplantation method for transplanting an organ.

In organ transplant surgery, the organs removed from the donor are stored in a cooled state. This is because in a so-called warm ischemic state in which blood flow is interrupted at normal temperature, metabolism in the organ tends to cause deterioration of the organ. Specifically, the temperature of the organ is maintained at a low temperature by injecting a low-temperature preservation solution into the removed organ, or by directly sprinkling saline containing ice slash around the organ. I do. Thereby, metabolism of the organ is suppressed.

However, when transplanting an organ to a recipient, the organ is placed in the body cavity of the recipient, and a procedure such as vascular anastomosis is performed. At this time, since the cooling of the organ cannot be continued, the temperature of the organ increases due to the body temperature or the outside temperature of the recipient, and the organ gradually becomes warm and ischemic. For this reason, transplant surgery operators must perform procedures such as vascular anastomosis in the shortest possible time, or keep the organ to be transplanted at a low temperature by placing ice or the like in the abdominal cavity. Did not. In the latter case, not only the organs but also the operator's hands are cooled at the same time, which is disadvantageous in vascular anastomosis requiring precision.

In view of this, the inventor of the present application has disclosed a technique in Patent Document 1 in which a heat-insulating sheet is inserted between a recipient and an organ during transplantation of the organ into the recipient, thereby suppressing the temperature rise of the organ. Proposed. The sheet of Patent Literature 1 has a heat insulating layer and two waterproof layers surface-bonded to both surfaces of the heat insulating layer.

JP 2018-000309 A

However, the sheet of Patent Document 1 does not completely cover the organ. For this reason, there has been a problem that a portion of the surface of the organ that is not covered with the sheet is heated. Further, there is a possibility that the end of the sheet inserted between the recipient and the organ may hinder the operation of the operator.

The present invention has been made in view of such circumstances, and a medical device and a transplant that can further suppress an increase in the temperature of an organ during transplantation of the organ to a recipient and that are less likely to hinder the operation of a surgeon. The aim is to provide a method.

The first invention of the present application is an organ storage bag that stores an organ, comprising: an opening through which the organ can pass; and a bag-shaped heat insulating sheet that holds the organ inserted through the opening. The heat insulating sheet has a pair of waterproof layers and a heat insulating layer located between the pair of waterproof layers.

The second invention of the present application is the organ-housing bag of the first invention, further comprising an opening / closing member that opens and closes the opening at least partially.

３A third invention of the present application is the organ-housing bag of the second invention, wherein the opening / closing member is an operation cord for contracting the opening.

The fourth invention of the present application is the organ-containing bag according to the second invention, wherein the opening / closing member is a stretchable elastic member provided in the opening.

５A fifth invention of the present application is the organ storage bag according to the second invention, wherein the opening / closing member has a pair of fasteners that can be fixed and separated from each other.

The sixth invention of the present application is the organ-containing bag according to any one of the first invention to the fifth invention, wherein the heat-insulating layer is made of foamed polyethylene, foamed polystyrene, flexible urethane foam, polystyrene, or nonwoven fabric, The waterproof layer is made of polyvinylidene fluoride, silicone resin, polyurethane, fluorine resin, fluorine rubber, urethane rubber, vinyl chloride, nylon, polyethylene, or polyurethane elastomer.

The seventh invention of the present application is the organ-containing bag according to any one of the first invention to the sixth invention, further comprising a waterproof inner bag provided inside the heat insulating sheet.

The eighth invention of the present application is the organ storage bag according to any one of the first invention to the sixth invention, further comprising a waterproof outer bag provided outside the heat insulating sheet.

The ninth invention of the present application is a transplantation method for transplanting an organ isolated from a donor, which is a non-human animal, to a recipient, which is a non-human animal, the method comprising: Accommodating an organ; b) after the step a), disposing the organ accommodating bag accommodating the organ in a body cavity of the recipient; c) after the step b), A step of anastomosing the blood vessel of the recipient and the blood vessel of the organ; and d) after the step c), removing the organ from the organ storage bag and removing the organ storage bag.

The tenth invention of the present application is the transplantation method of the ninth invention, wherein the heat insulating sheet has a pair of waterproof layers and a heat insulating layer located between the pair of waterproof layers.

According to the first to tenth aspects of the present invention, when an organ is placed in a body cavity of a recipient, the entire surface of the organ can be covered with the heat insulating sheet by housing the organ in the organ housing bag. it can. This makes it possible to perform anastomosis of blood vessels while suppressing an increase in the temperature of the organ due to the recipient's body temperature or external temperature. As a result, it is possible to suppress the organ from being in a warm ischemic state, and to suppress the occurrence of a disorder after the operation. Further, since the heat insulating sheet is formed in a bag shape, the end of the heat insulating sheet does not easily hinder the operation of the operator.

Especially, according to the second aspect of the present invention, by closing the opening, it is possible to prevent the organ from dropping out of the organ storage bag.

Especially, according to the fourth aspect of the present invention, the opening can be easily opened and closed. In addition, the risk of damaging the organ due to the opening / closing operation is small.

Especially, according to the fifth aspect of the present invention, the opening can be easily opened and closed. In addition, the risk of damaging the organ due to the opening / closing operation is small.

Especially, according to the seventh aspect of the present invention, a low-temperature preservation solution can be put in the inner bag together with the organ. Thereby, it is possible to further suppress an increase in the temperature of the organ.

FIG. 2 is an external view of the organ storage bag according to the first embodiment. It is a partial sectional view of a heat insulation sheet. It is the flowchart which showed the flow of the operation | work which a surgeon performs in a transplant operation. It is an outline view of an organ storage bag concerning a 2nd embodiment. It is an outline view of an organ storage bag concerning a 3rd embodiment. It is an external view of the organ storage bag which concerns on 4th Embodiment. It is a development view of an organ storage bag concerning a 5th embodiment. It is a development view of an organ storage bag concerning a 6th embodiment. It is an external view of the organ storage bag which concerns on 7th Embodiment. It is an outline view of an organ storage bag concerning an 8th embodiment. It is the graph which showed the temperature change when a kidney was stored in a pseudo peritoneal cavity after cryopreservation.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

において In the present application, "donor" and "recipient" may be human or non-human animal. That is, in the present application, the “organ” may be a human organ or a non-human animal organ. Further, the non-human animal may be a rodent including a mouse and a rat, an ungulate including a pig, a goat and a sheep, a non-human primate including a chimpanzee, and other non-human mammals. Other animals may be used.

<1. First Embodiment>
<1-1. About organ storage bag>
FIG. 1 is an external view of an organ storage bag 1 according to the first embodiment. The organ storage bag 1 is a container for temporarily storing the organ 9 in a transplant operation for transplanting the organ 9 extracted from a donor to a recipient. That is, the organ storage bag 1 is a medical device intended to be used for a transplant operation on the organ 9.

臓器 Examples of the organ 9 stored in the organ storage bag 1 include a kidney, a heart, a lung, and a spleen. In these organs 9, blood vessels 91 to be anastomosed in the transplant operation are concentrated on one side of the organ 9. The structure of the organ storage bag 1 of the present embodiment is particularly suitable for these organs 9. However, the organ housing bag of the present invention may house another organ such as a liver.

As shown in FIG. 1, the organ storage bag 1 has a bag-shaped heat insulating sheet 10 for holding the organ 9. The organ storage bag 1 may be formed in a bag shape by suturing, bonding, or welding two or more heat insulating sheets 10, or may be formed of one seamless heat insulating sheet 10. It may be something. The size of the organ storage bag 1 is slightly larger than the target organ 9 so that the organ 9 can be easily inserted and removed, and the organ 9 does not easily move inside. A gusset may be provided at the bottom or side of the organ storage bag 1.

臓器 The organ storage bag 1 has an opening 20 and an operation cord 30 for opening and closing the opening 20. The opening 20 has a size that allows the organ 9 to pass in the open state. The operation cord 30 may be a non-stretchable string or a stretchable string made of an elastic material such as rubber. The operation cord 30 is passed through an annular insertion hole 21 provided along the edge of the opening 20. When the operation cord 30 is pulled, the opening 20 of the organ storage bag 1 contracts like a drawstring bag. Thereby, the opening 20 is closed. That is, in the present embodiment, the operation cord 30 serves as an opening / closing member for opening and closing the opening 20. Note that the operation cord 30 may be configured to contract the opening 20 by pulling only one end, or may be configured to contract the opening 20 by pulling both ends.

FIG. 2 is a partial cross-sectional view of the heat insulating sheet 10. As shown in FIG. 2, the heat insulating sheet 10 has a pair of waterproof layers 12 and a heat insulating layer 11 located between the pair of waterproof layers 12. The pair of waterproof layers 12 are fixed to both surfaces of the heat insulating layer 11 by, for example, adhesion or fusion. Thereby, both surfaces of the heat insulating layer 11 are covered with the waterproof layer 12. In order to obtain high heat insulating properties, the thickness of the heat insulating layer 11 is preferably larger than the thickness of the waterproof layer 12.

多孔 The heat insulating layer 11 is made of a porous material or cloth that can be deformed flexibly and has heat insulating properties. Specifically, as the heat insulating layer 11, foamed polyethylene, foamed polystyrene, soft urethane foam, polystyrene, or nonwoven fabric can be used. In addition, the heat insulation layer 11 may be comprised by one layer, and may be comprised by two or more layers. When it is composed of a plurality of layers, the whole of the plurality of layers becomes the “heat insulating layer” in the present invention.

フィルム A film that is flexible and deformable, has waterproof properties, and has biocompatibility and sterilization holding properties is used for the waterproof layer 12. Specifically, polyvinylidene fluoride, silicone resin, polyurethane, fluorine resin, fluorine rubber, urethane rubber, vinyl chloride, nylon, polyethylene, or polyurethane elastomer can be used for the waterproof layer 12.

防水 Further, it is preferable that the waterproof layer 12 has a function of adhering to the organ 9 by the action of van der Waals force, electrostatic coupling, or suction under reduced pressure. When the waterproof layer 12 comes into close contact with the organ 9, the movement of the organ 9 inside the organ storage bag 1 is suppressed. Therefore, it is possible to suppress damage to the organ 9 and to further enhance the effect of suppressing a rise in temperature of the organ 9 described later.

<1-2. About the flow of organ transplants>
Next, the flow of a transplant operation using the above-mentioned organ storage bag 1 will be described. FIG. 3 is a flowchart showing a flow of operations performed by the surgeon in the transplant operation.

行う When performing a transplant operation, first, the organ 9 is extracted from the donor (step S1). Specifically, a blood vessel extending from the organ 9 of the donor is cut, and the organ 9 is taken out of the body cavity of the donor. The removed organ 9 is stored while being immersed in a low-temperature storage solution (step S2). As the preservation solution, for example, physiological saline maintained at 4 ° C is used. When the organ 9 enters a so-called warm ischemic state in which blood flow is interrupted at normal temperature, metabolism in the organ 9 tends to cause deterioration. Therefore, in step S2, the deterioration of the organ 9 is suppressed by storing the organ 9 at a temperature lower than room temperature.

In step S2, a pipe may be connected to the blood vessel 91 of the organ 9, and the organ 9 may be stored in a state where the preservation solution is perfused into the organ 9. The perfusion of the preservation solution may be continued until Step S5 described below.

Subsequently, the organ 9 stored at a low temperature is stored in the organ storage bag 1 (step S3). Specifically, the opening 20 of the organ storage bag 1 is opened, and the organ 9 is inserted into the bag-shaped heat insulating sheet 10 through the opening 20. Thus, the organ 9 is held inside the bag-shaped heat insulating sheet 10. Thereafter, the operation cord 30 is pulled to close the opening 20 of the organ storage bag 1. This prevents the organ 9 from falling off from the organ storage bag 1. However, in step S5 described below, only the blood vessel 91 of the organ 9 to be anastomosed with the blood vessel of the recipient is kept exposed from the opening 20 to the outside.

Next, the abdomen of the recipient is opened, and the organ-containing bag 1 containing the organ 9 is placed in the body cavity of the recipient (step S4). Then, the blood vessel of the recipient and the blood vessel 91 of the organ 9 exposed to the outside through the opening 20 of the organ storage bag 1 are anastomosed (Step S5). Thereafter, the opening 20 of the organ storage bag 1 is opened, and the organ 9 after the blood vessel anastomosis is taken out of the organ storage bag 1. Then, the organ storage bag 1 is removed from the body cavity of the recipient (step S6).

血液 During the work of steps S4 to S5, blood has not yet flowed inside the organ 9. However, since the organ 9 accommodated in the organ accommodation bag 1 is covered with the heat insulating sheet 10, it is hardly affected by external temperature. Therefore, an increase in the temperature of the organ 9 due to the body temperature or the outside air temperature of the recipient is suppressed. Therefore, it is possible to suppress the deterioration of the organ 9 due to metabolism due to the warm ischemia state. As a result, the occurrence of a failure after the operation can be suppressed.

Particularly, the organ storage bag 1 covers the entire surface of the organ 9. For this reason, the effect of suppressing the temperature rise of the organ 9 is greater than when only a part of the surface of the organ 9 is covered. Further, damage to the organ 9 during the operation can be suppressed. Further, since the heat insulating sheet 10 is formed in a bag shape, the end of the heat insulating sheet 10 does not easily hinder the operation of the operator.

In the present embodiment, the opening 20 of the organ storage bag 1 is contracted by pulling the operation cord 30. With this structure, the operator can easily open and close the opening 20. In addition, the risk of damaging the organ 9 by the opening / closing operation is small.

<2. Second Embodiment>
Subsequently, another embodiment of the present invention will be described. In the following second to eighth embodiments, differences from the above-described first embodiment will be mainly described, and the same points as those in the first embodiment will not be described repeatedly.

FIG. 4 is an external view of the organ storage bag 1 according to the second embodiment. The organ storage bag 1 of the present embodiment differs from the first embodiment in the structure of the opening / closing member that opens and closes the opening 20.

臓器 As shown by the broken line in FIG. 4, the organ storage bag 1 of the second embodiment has an elastic member 40 as an opening / closing member. The elastic member 40 is passed through an annular insertion hole provided along the edge of the opening 20 of the organ storage bag 1. As the elastic member 40, for example, natural rubber or synthetic rubber that can be elastically expanded and contracted is used. When no external force is applied, the elastic member 40 keeps the opening 20 in a contracted state. However, the operator of the transplant operation can open the opening 20 by stretching the elastic member 40. Then, the organ 9 can be inserted into the organ storage bag 1 or the organ 9 can be removed from the organ storage bag 1 through the opened opening 20.

臓器 The organ storage bag 1 of the present embodiment can also be used in a transplant operation performed in the same procedure as in FIG. Then, in steps S4 to S5 of FIG. 3, by covering the entire surface of the organ 9 with the heat insulating sheet 10, the rise in the temperature of the organ 9 can be suppressed and the damage to the organ 9 can be suppressed. Further, since the heat insulating sheet 10 is formed in a bag shape, the end of the heat insulating sheet 10 does not easily hinder the operation of the operator.

In particular, in the structure of the present embodiment, after the organ 9 is inserted into the organ storage bag 1, the opening 20 of the organ storage bag 1 is automatically closed by the contraction force of the elastic member 40. Therefore, there is no need to pull the operation cord 30 to close the opening 20 unlike the first embodiment. Therefore, the operation of the transplant operation can be performed more quickly. Further, similarly to the first embodiment, the risk of damaging the organ 9 by opening and closing the opening 20 is small.

The elastic member 40 may be provided annularly around the opening 20 or may be provided partially around the opening 20.

<3. Third Embodiment>
FIG. 5 is an external view of the organ storage bag 1 according to the third embodiment. The organ storage bag 1 of the present embodiment differs from the first embodiment in the structure of the opening / closing member that opens and closes the opening 20.

As shown in FIG. 5, the organ storage bag 1 of the third embodiment has a line fastener 50 as an opening / closing member. The line fastener 50 has a pair of engagement teeth (fasteners) 51 provided in the opening 20 and a slider 52. When the slider 52 is moved to one side along the working teeth row 51, the pair of working teeth rows 51 engage with each other, and the working teeth rows 51 are fixed to each other. As a result, the opening 20 is closed. When the slider 52 is moved to the other side along the tooth row 51, the engagement of the pair of tooth rows 51 is released, and the opening 20 is opened.

<4. Fourth embodiment>
FIG. 6 is an external view of the organ storage bag 1 according to the fourth embodiment. The organ storage bag 1 of the present embodiment differs from the first embodiment in the structure of the opening / closing member that opens and closes the opening 20.

臓器 As shown in FIG. 6, the organ storage bag 1 of the fourth embodiment has a zipper 60 as an opening / closing member. The zipper 60 has a pair of zip members (fasteners) 61 provided in the opening 20. The pair of zip members 61 have minute projections and depressions 62 fitted to each other. When pressure is applied by bringing the pair of zip members 61 into contact with each other, the concave and convex portions 62 of one zip member 61 and the concave and convex portions 62 of the other zip member 61 are elastically fitted, and the zip members 61 are fixed to each other. . As a result, the opening 20 is closed. When the pair of zip members 61 are separated from each other, the fitting of the concave and convex portions 62 is released, and the opening 20 is opened.

<5. Fifth Embodiment>
FIG. 7 is a development view of the organ storage bag 1 according to the fifth embodiment. The organ storage bag 1 of the present embodiment differs from the first embodiment in the shape of the heat insulating sheet 10 and the structure of the opening / closing member.

臓器 As shown in FIG. 7, the organ storage bag 1 of the fifth embodiment is formed in a bag shape by folding one flat heat insulating sheet 10. The heat insulating sheet 10 has a first piece 14 and a second piece 15 that are line-symmetric with the fold line 13 as a target axis. The organ storage bag 1 of the present embodiment has a hook-and-loop fastener 70 as an opening / closing member. The surface fastener 70 has a plurality of engaging members (fasteners) 71 provided on the first piece 14 and the second piece 15. When the heat insulating sheet 10 is folded at the fold line 13, the engaging member 71 of the first piece 14 and the engaging member 71 of the second piece 15 come into contact.

That is, the organ storage bag 1 has a plurality of pairs of engagement members 71 that come into contact with each other when the heat insulating sheet 10 is folded along the fold line 13. One of the pair of engaging members 71 that contacts each other has a large number of fine hooks. The other of the pair of engaging members 71 that come into contact with each other has a large number of fine loops with which hooks can be engaged. Therefore, when the pair of engaging members 71 come into contact with each other, the two engaging members 71 are fixed to each other by the engagement between the hook and the loop. Thereby, the heat insulating sheet 10 is maintained in a bag shape, and the opening 20 is partially closed. When the pair of engaging members 71 are separated from each other, the engagement between the two members is released, and the opening 20 is opened.

Especially, in the structure of the present embodiment, the opening 20 can be widely opened until the heat insulating sheet 10 becomes flat. For this reason, the work of inserting the organ 9 into the organ housing bag 1 and removing the organ 9 from the organ housing bag 1 is easy. In addition, the risk of damaging the organ 9 during insertion of the organ 9 into the organ storage bag 1 and removal of the organ 9 from the organ storage bag 1 is small.

<6. Sixth embodiment>
FIG. 8 is an external view of the organ storage bag 1 according to the sixth embodiment. The organ storage bag 1 of the present embodiment differs from the first embodiment in the shape of the heat insulating sheet 10 and the structure of the opening / closing member.

臓器 As shown in FIG. 8, the organ storage bag 1 of the sixth embodiment is formed in a bag shape by folding one flat heat insulating sheet 10. The heat insulating sheet 10 has a first piece 14 and a second piece 15 that are line-symmetric with the fold line 13 as a target axis. The organ storage bag 1 of the present embodiment has a snap button 80 as an opening / closing member. The snap button 80 has a plurality of buttons (fasteners) 81 provided on the first piece 14 and the second piece 15. When the heat insulating sheet 10 is folded along the fold line 13, the button 81 of the first piece 14 and the button 81 of the second piece 15 come into contact.

That is, the organ storage bag 1 has a plurality of pairs of buttons 81 that come into contact with each other when the heat insulating sheet 10 is folded along the fold line 13. One of the pair of buttons 81 contacting each other is a male button having a convex portion. The other of the pair of buttons 81 that are in contact with each other is a female button having a concave portion. For this reason, when pressure is applied by bringing the pair of buttons 81 into contact with each other, the two buttons 81 are fixed to each other by the fitting of the convex portion and the concave portion. Thereby, the heat insulating sheet 10 is maintained in a bag shape, and the opening 20 is partially closed. When the pair of buttons 81 are separated from each other, the fitting of the buttons 81 is released, and the opening 20 is opened.

Especially, in the structure of the present embodiment, the opening 20 can be widely opened until the heat insulating sheet 10 becomes flat. For this reason, the work of inserting the organ 9 into the organ housing bag 1 and removing the organ 9 from the organ housing bag 1 is easy. In addition, the risk of damaging the organ 9 during insertion of the organ 9 into the organ housing bag 1 and removal of the organ 9 from the organ housing bag 1 is small.

<7. Seventh embodiment>
FIG. 9 is an external view of the organ storage bag 1 according to the seventh embodiment. The organ storage bag 1 of the present embodiment differs from the first embodiment in that it does not have an opening / closing member for opening and closing the opening 20.

As in the present embodiment, even if the opening / closing member is not provided on the organ housing bag 1 itself, the opening 20 of the organ housing bag 1 can be closed by using a fixing member such as a separate clip or tape. it can. Further, by removing the fixing member, the opening 20 of the organ storage bag 1 can be opened.

<8. Eighth embodiment>
FIG. 10 is an external view of the organ storage bag 1 according to the eighth embodiment. The organ storage bag 1 of the present embodiment is different from the first embodiment in that a waterproof inner bag 90 is provided inside the bag-shaped heat insulating sheet 10.

材料 The inner bag 90 is made of a material that can be flexibly deformed, has waterproof properties, and has biocompatibility and sterilization holding properties. Specifically, as the material of the inner bag 90, polyvinylidene fluoride, silicone resin, polyurethane, fluorine resin, fluorine rubber, urethane rubber, vinyl chloride, nylon, polyethylene, or polyurethane elastomer can be used. Further, the inner bag 90 is formed of one seamless film, and can hold the liquid inside.

When a plurality of heat insulating sheets 10 are sewn into a bag shape, it is difficult to completely seal the sewn portion. However, if the waterproof inner bag 90 is provided as shown in FIG. 10, the inside of the inner bag 90 can be a closed space.

臓器 The organ storage bag 1 of the present embodiment can also be used in a transplant operation performed in the same procedure as in FIG. In particular, in the present embodiment, a low-temperature preservative solution can be put inside the inner bag 90 together with the organ 9. Further, a low-temperature storage solution can be additionally poured into the inner bag 90 in the middle of step S5 in FIG. Thereby, the temperature rise of the organ 9 can be further suppressed.

In the structure of the fifth and sixth embodiments, when the inner bag 90 is provided, the inner surface of the first piece 14 and the inner surface of the second piece 15 of the heat insulating sheet 10 are respectively provided on the inner surface. The bag 90 may be fixed. The inner bag 90 on the first piece 14 side and the inner bag 90 on the second piece 15 side may be connected near the fold line 13.

Further, the organ storage bag 1 may have a waterproof outside on the outside of the bag-shaped heat insulating sheet 10. The same material as that of the inner bag 90 described above can be used for the outer bag. The outer bag may be fixed to the bag-shaped heat insulating sheet 10 by adhesion, welding, or the like, or may be separate from the heat insulating sheet 10. If it is separate from the heat insulating sheet 10, the outer bag may be applied not only to the structures of the above-described first to fourth and seventh embodiments, but also to the fifth and sixth embodiments. Can be.

<9. Experimental example>
FIG. 11 is a graph showing changes in kidney temperature when a kidney isolated from a pig is stored in a storage solution at 4 ° C. for 24 hours and then placed in a 37 ° C. environment (pseudo-peritoneal cavity). . A polygonal line C1 in the graph indicates a change in the temperature of the kidney when not stored in the organ storage bag (case 1). A broken line C2 in the graph indicates a change in the temperature of the kidney when housed in the organ housing bag (case 2). The experiment was performed twice in each of Case 1 and Case 2. Each of the polygonal lines C1 and C2 in FIG.

より From the results in FIG. 11, the kidney contained in the organ-containing bag has a lower temperature increase in the pseudo-abdominal cavity than the kidney not contained in the organ-containing bag. Therefore, it can be seen that the use of the organ storage bag can suppress an increase in the temperature of the organ during the transplant operation. In particular, the average time required for vascular anastomosis is about 30 minutes, but according to the results in FIG. 11, at the time when 30 minutes have passed in the simulated abdominal cavity, in Case 1, the kidney temperature became 35 °. On the other hand, in Case 2, the temperature of the kidney was suppressed to 30 °. This 5 ° temperature difference has a significant effect on metabolic progress in the kidney. In other words, it can be said that the use of the organ storage bag can significantly suppress the progress of metabolism in the organ.

In the experiment of FIG. 11, an organ storage bag without an opening / closing member as in the seventh embodiment was used. It is considered that when an organ storage bag having an opening / closing member is used, a rise in kidney temperature can be further suppressed.

<10. Modification>
The main embodiment of the present invention has been described above, but the present invention is not limited to the above embodiment.

For example, another layer may be provided between the heat insulating layer 11 and the waterproof layer 12 in order to further enhance the heat insulating effect of the heat insulating sheet 10. As another layer, for example, a film on which a metal film is deposited can be used. Specifically, a polyethylene sheet on which aluminum is deposited can be used. In this way, radiation such as near-infrared rays from the recipient's body toward the organ 9 is reflected by the metal film. Therefore, it is possible to further suppress the temperature of the organ 9 stored in the organ storage bag 1 from rising.

温 In addition, a temperature indicator whose color changes depending on the temperature may be used for the waterproof layer 12 of the heat insulating sheet 10. For example, a temperature indicating member can be formed by mixing a compound that changes color depending on temperature with the biocompatible material described in the above embodiment. If the temperature indicating member is used, the temperature of the organ 9 can be estimated from the color. Therefore, it is possible to take a measure according to the rise in the temperature of the organ 9.

構造 In addition, the detailed structure of the organ storage bag does not need to completely match the structure shown in each drawing of the present application. In addition, the elements appearing in the above-described first to eighth embodiments and the modifications may be appropriately combined as long as no contradiction occurs.

REFERENCE SIGNS LIST 1 organ storage bag 9 organ 10 heat insulating sheet 11 heat insulating layer 12 waterproof layer 13 fold line 14 first piece 15 second piece 20 opening 21 insertion hole 30 operation cord 40 elastic member 50 wire fastener 51 service tooth row 52 slider 60 zipper 61 Zip member 62 Uneven portion 70 Surface fastener 71 Engagement member 80 Snap button 81 Button 90 Inner bag 91 Blood vessel

Claims

An organ storage bag for storing an organ,
An opening through which organs can pass;
A bag-shaped heat-insulating sheet that holds an organ inserted through the opening,
With
The heat insulating sheet,
A pair of waterproof layers,
A heat insulating layer located between the pair of waterproof layers,
An organ storage bag having:
The organ storage bag according to claim 1,
An organ storage bag further comprising an opening / closing member for opening and closing the opening at least partially.
An organ storage bag according to claim 2,
The organ storage bag, wherein the opening / closing member is an operation cord for contracting the opening.
An organ storage bag according to claim 2,
The organ storage bag, wherein the opening / closing member is a stretchable elastic member provided in the opening.
An organ storage bag according to claim 2,
The organ storage bag, wherein the opening / closing member has a pair of fasteners that can be fixed and separated from each other.
The organ storage bag according to any one of claims 1 to 5, wherein
The heat insulating layer is made of foamed polyethylene, foamed polystyrene, soft urethane foam, polystyrene, or nonwoven fabric,
The organ storage bag, wherein the waterproof layer is made of polyvinylidene fluoride, silicone resin, polyurethane, fluororesin, fluororubber, urethane rubber, vinyl chloride, nylon, polyethylene, or polyurethane elastomer.
The organ storage bag according to any one of claims 1 to 6, wherein
An organ storage bag, further comprising a waterproof inner bag provided inside the heat insulating sheet.
The organ storage bag according to any one of claims 1 to 6, wherein
An organ storage bag further comprising a waterproof outer bag provided outside the heat insulating sheet.
A transplant method for transplanting an organ extracted from a donor that is a non-human animal to a recipient that is a non-human animal,
a) a step of housing the organ in an organ storage bag having a bag-shaped heat insulating sheet;
b) after the step a), disposing the organ-containing bag containing the organ in a body cavity of the recipient;
c) after the step b), anastomosis between the blood vessel of the recipient and the blood vessel of the organ;
d) after the step c), removing the organ from the organ storage bag and removing the organ storage bag;
A transplantation method comprising:
The transplantation method according to claim 9, wherein
The heat insulating sheet,
A pair of waterproof layers,
A heat insulating layer located between the pair of waterproof layers,
A transplantation method comprising: