JP7143167B2 - Organ-receiving bag and transplantation method - Google Patents

Description

TECHNICAL FIELD The present invention relates to an organ-accommodating bag for containing an organ and a transplantation method for transplanting an organ.

In organ transplant surgery, the organ removed from the donor is preserved in a cooled state. This is because when a so-called warm ischemic state occurs, in which the blood flow is interrupted at room temperature, the internal organs are likely to deteriorate due to metabolism in the organs. Specifically, the temperature of the organ is maintained at a low temperature by injecting a low-temperature preservation solution into the excised organ, or by directly sprinkling physiological saline containing ice slush around the organ. do. This suppresses the metabolism of the organ.

However, when an organ is transplanted into 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 rises due to the body temperature of the recipient and the ambient temperature, and the organ gradually enters a warm ischemic state. For this reason, transplant surgeons must keep the organs to be transplanted at a low temperature by performing procedures such as vascular anastomosis in as short a time as possible, or by inserting ice into the abdominal cavity. I didn't. In the latter case, not only the organ but also the operator's hands are cooled at the same time, which is disadvantageous in vascular anastomosis, which requires precision.

Therefore, the inventors of the present application disclosed a technique in Patent Document 1 to suppress temperature rise of an organ by inserting a sheet having a heat insulating function between the recipient and the organ when the organ is transplanted into the recipient. Proposed. The sheet of Patent Document 1 has a heat insulating layer and two waterproof layers surface-bonded to both sides of the heat insulating layer.

Japanese Patent Application Laid-Open No. 2018-000309

However, the sheet of Patent Document 1 does not completely cover organs. Therefore, there is a problem that the surface of the organ, which is not covered with the sheet, is heated. In addition, there is a risk that the edge of the sheet inserted between the recipient and the organ will interfere with the operation of the surgeon.

The present invention has been made in view of such circumstances, and provides a medical device and a transplant that can further suppress the temperature rise of the organ at the time of transplantation of the organ to the recipient and hardly interfere with the operation of the surgeon. The purpose is to provide a method.

A first invention of the present application is an organ-accommodating bag for accommodating an organ, comprising an opening through which the organ can pass, a bag-shaped heat insulating sheet for holding the organ inserted through the opening, and the heat insulating sheet . a waterproof inner bag provided inside the heat insulating sheet, the heat insulating sheet having a pair of waterproof layers and a heat insulating layer positioned between the pair of waterproof layers.
A second invention of the present application is an organ storage bag for storing an organ, comprising an opening through which the organ can pass, a bag-like heat insulating sheet for holding the organ inserted through the opening, and the heat insulating sheet. and a waterproof outer bag provided on the outside of the heat insulating sheet, wherein the heat insulating sheet has a pair of waterproof layers and a heat insulating layer positioned between the pair of waterproof layers.

A third invention of the present application is the organ-accommodating bag according to the first invention or the second invention , further comprising an opening/closing member that at least partially opens and closes the opening.

A fourth invention of the present application is the organ-accommodating bag according to the third invention, wherein the opening/closing member is an operation cord for contracting the opening.

A fifth invention of the present application is the organ-accommodating bag according to the third invention, wherein the opening/closing member is a stretchable elastic member provided in the opening.

A sixth invention of the present application is the organ-accommodating bag according to the third invention, wherein the opening/closing member has a pair of fasteners that can be fixed and separated from each other.

A seventh invention of the present application is the organ storage bag according to any one of the first invention to the sixth invention, wherein the heat insulating layer is made of polyethylene foam, polystyrene foam, soft urethane foam, polystyrene, or non-woven fabric, The waterproof layer is made of polyvinylidene fluoride, silicone resin, polyurethane, fluororesin, fluororubber, urethane rubber, vinyl chloride, nylon, polyethylene, or polyurethane elastomer.

The eighth invention of the present application is a transplantation method for transplanting an organ removed from a non-human animal donor into a non-human animal recipient, comprising: a) housing the organ in an organ-receiving bag; b) placing the organ-accommodating bag containing the organ in the body cavity of the recipient after step a); and d) taking out the organ from the organ-receiving bag and removing the organ-receiving bag after the step c), wherein the organ-receiving bag is It comprises an opening through which an organ can pass, a bag-like heat insulating sheet for holding the organ inserted through the opening, and a waterproof inner bag provided inside the heat insulating sheet.
A ninth invention of the present application is a transplantation method for transplanting an organ excised from a non-human animal donor into a non-human animal recipient, comprising: a) housing the organ in an organ -receiving bag; b) placing the organ-accommodating bag containing the organ in the body cavity of the recipient after step a); and d) taking out the organ from the organ-receiving bag and removing the organ-receiving bag after the step c), wherein the organ-receiving bag is It comprises an opening through which an organ can pass, a bag-shaped heat insulating sheet for holding the organ inserted through the opening, and a waterproof outer bag provided outside the heat insulating sheet .

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

According to the first to tenth inventions of the present application, when the organ is placed in the body cavity of the recipient, the entire surface of the organ can be covered with the heat-insulating sheet by storing the organ in the organ-receiving bag. can. As a result, blood vessel anastomosis can be performed while suppressing an increase in the temperature of the organ due to the body temperature of the recipient and the ambient temperature. As a result, it is possible to prevent the organ from entering a warm ischemic state, thereby suppressing the occurrence of disorders after surgery. In addition, since the heat insulating sheet is bag-shaped, the edges of the heat insulating sheet are less likely to interfere with the operation of the surgeon.
In particular, according to the first and eighth inventions, a low-temperature preservative solution can be placed in the inner bag together with the organ. Thereby, it is possible to further suppress the temperature rise of the internal organs.

In particular, according to the third invention of the present application, by closing the opening, it is possible to prevent the organ from dropping out of the organ-receiving bag.

In particular, according to the fifth invention of the present application, the opening can be easily opened and closed. In addition, there is little risk of injury to internal organs due to opening and closing operations.

In particular, according to the sixth invention of the present application, the opening can be easily opened and closed. In addition, there is little risk of injury to internal organs due to opening and closing operations.

1 is an external view of an organ-accommodating bag according to a first embodiment; FIG. It is a partial sectional view of a heat insulation sheet. 2 is a flow chart showing the flow of operations performed by a surgeon in transplant surgery. FIG. 10 is an external view of an organ-accommodating bag according to a second embodiment; FIG. 11 is an external view of an organ-accommodating bag according to a third embodiment; FIG. 11 is an external view of an organ-accommodating bag according to a fourth embodiment; FIG. 11 is an exploded view of an organ-accommodating bag according to a fifth embodiment; FIG. 11 is an exploded view of an organ-accommodating bag according to a sixth embodiment; FIG. 11 is an external view of an organ-accommodating bag according to a seventh embodiment; FIG. 21 is an external view of an organ-accommodating bag according to an eighth embodiment; FIG. 10 is a graph showing temperature changes when kidneys are placed in a simulated abdominal cavity after cryopreserved.

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, other non-human mammals, and mammals. It may be an animal other than

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

Examples of the organ 9 accommodated in the organ-accommodating bag 1 include kidney, heart, lung, and spleen. Blood vessels 91 to be anastomosed in these organs 9 are concentrated on one side of the organs 9 . The structure of the organ-accommodating bag 1 of this embodiment is particularly suitable for these organs 9 . However, the organ-accommodating bag of the present invention may contain other organs such as the liver.

As shown in FIG. 1, the organ-accommodating bag 1 has a bag-like heat-insulating sheet 10 that holds an organ 9 therein. The organ-accommodating bag 1 may be configured in a bag shape by sewing, bonding, or welding two or more heat insulating sheets 10, or may be configured by one seamless heat insulating sheet 10. can be anything. The size of the organ-accommodating bag 1 is slightly larger than the target organ 9 so that the organ 9 can be easily inserted and taken out and the organ 9 does not easily move inside. A gusset may be provided on the bottom or side of the organ-accommodating bag 1 .

The organ-accommodating bag 1 also has an opening 20 and an operation string 30 for opening and closing the opening 20 . The opening 20 has a size that allows the organ 9 to pass through in the open state. The operation string 30 may be a non-stretchable string or a stretchable string made of an elastic material such as rubber. The operating string 30 is passed through an annular insertion hole 21 provided along the edge of the opening 20 . When the operating string 30 is pulled, the opening 20 of the organ-accommodating bag 1 contracts like a drawstring bag. The opening 20 is thereby closed. That is, in this embodiment, the operation string 30 serves as an opening/closing member for opening/closing the opening 20 . The operation string 30 may be one that contracts the opening 20 by pulling only one end, or one that contracts 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. As shown in FIG. 2 , the heat insulating sheet 10 has a pair of waterproof layers 12 and a heat insulating layer 11 positioned between the pair of waterproof layers 12 . The pair of waterproof layers 12 are surface-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 . The thickness of the heat insulating layer 11 is preferably larger than the thickness of the waterproof layer 12 in order to obtain high heat insulating properties.

The heat insulating layer 11 is made of a porous material or fabric that is flexibly deformable and has heat insulating properties. Specifically, foamed polyethylene, foamed polystyrene, flexible urethane foam, polystyrene, or non-woven fabric can be used as the heat insulating layer 11 . In addition, the heat insulating layer 11 may be composed of a single layer, or may be composed of a plurality of layers. When composed of multiple layers, the entirety of the multiple layers serves as the "heat insulating layer" in the present invention.

The waterproof layer 12 uses a film that is flexibly deformable, waterproof, biocompatible, and sterilization-retentive. Specifically, the waterproof layer 12 can be made of polyvinylidene fluoride, silicone resin, polyurethane, fluororesin, fluororubber, urethane rubber, vinyl chloride, nylon, polyethylene, or polyurethane elastomer.

Moreover, it is preferable that the waterproof layer 12 has the ability to adhere to the internal organs 9 by van der Waals force, electrostatic coupling, or decompression adsorption. If the waterproof layer 12 is in close contact with the organ 9, movement of the organ 9 inside the organ-receiving bag 1 is suppressed. Therefore, damage to the organ 9 can be suppressed, and the effect of suppressing temperature rise of the organ 9, which will be described later, can be further enhanced.

<1-2. About the Flow of Organ Transplantation＞
Next, a flow of transplant surgery using the organ-accommodating bag 1 will be described. FIG. 3 is a flow chart showing the flow of operations performed by a surgeon in transplantation surgery.

When performing a transplant operation, first, an organ 9 is extracted from a donor (step S1). Specifically, the blood vessel extending from the donor's organ 9 is cut, and the organ 9 is removed from the donor's body cavity. The removed organ 9 is preserved while being immersed in a low-temperature preservation solution (step S2). For example, physiological saline maintained at 4° C. is used as the preservation solution. When the organ 9 is in a so-called warm ischemic state in which blood flow is interrupted at room temperature, metabolism in the organ 9 easily causes deterioration. Therefore, in step S2, deterioration of the organ 9 is suppressed by preserving the organ 9 at a temperature lower than room temperature.

In step S2, the organ 9 may be preserved while a pipe is connected to the blood vessel 91 of the organ 9 and the organ 9 is perfused with the preservation solution. Note that the perfusion of the preservation solution may be continued until step S5, which will be described later.

Subsequently, the cryopreserved organ 9 is accommodated in the organ-accommodating bag 1 (step S3). Specifically, the opening 20 of the organ-accommodating bag 1 is opened, and the organ 9 is inserted into the bag-shaped heat insulating sheet 10 through the opening 20 . Thereby, the organ 9 is held inside the bag-shaped heat insulating sheet 10 . After that, the operation string 30 is pulled to close the opening 20 of the organ-receiving bag 1 . This prevents the organ 9 from dropping out of the organ-accommodating bag 1 . However, in step S<b>5 described later, only the blood vessel 91 of the organ 9 to be anastomosed with the recipient's blood vessel is left exposed to the outside from the opening 20 .

Subsequently, the recipient's abdomen is opened, and the organ-accommodating bag 1 containing the organ 9 is placed in the body cavity of the recipient (step S4). Then, the recipient's blood vessel and the blood vessel 91 of the organ 9 exposed to the outside from the opening 20 of the organ-receiving bag 1 are anastomosed (step S5). After that, the opening 20 of the organ-accommodating bag 1 is opened, and the organ 9 after anastomosing the blood vessels is taken out from the organ-accommodating bag 1 . Then, the organ-accommodating bag 1 is removed from the body cavity of the recipient (step S6).

Blood is not yet flowing inside the organ 9 during the operations of steps S4 and S5. However, since the organ 9 accommodated in the organ-accommodating bag 1 is covered with the heat-insulating sheet 10, it is less susceptible to external temperature. Therefore, an increase in the temperature of the organ 9 due to the body temperature of the recipient or the ambient temperature is suppressed. Therefore, it is possible to prevent the organ 9 from entering a warm ischemic state and further deterioration due to metabolism. As a result, the occurrence of disorders after surgery can be suppressed.

In particular, the organ-accommodating bag 1 covers the entire surface of the organ 9 . Therefore, 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. Also, damage to the organ 9 during surgery can be suppressed. In addition, since the heat insulating sheet 10 is bag-shaped, the edges of the heat insulating sheet 10 are less likely to interfere with the operation of the surgeon.

Moreover, in this embodiment, the opening 20 of the organ-receiving bag 1 is contracted by pulling the operating string 30 . This structure allows the surgeon to easily open and close the opening 20 . In addition, there is little risk of damaging the organ 9 due to the opening/closing operation.

<2. Second Embodiment>
Next, another embodiment of the present invention will be described. In the following second to eighth embodiments, differences from the first embodiment will be mainly described, and duplicate descriptions of the same points as in the first embodiment will be omitted.

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

As indicated by broken lines in FIG. 4, the organ-receiving 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-accommodating bag 1 . The elastic member 40 is made of, for example, elastically stretchable natural rubber or synthetic rubber. When no external force is applied, the elastic member 40 maintains the opening 20 in a contracted state. However, the transplant surgeon can open the opening 20 by stretching the elastic member 40 . Then, the organ 9 can be inserted into the organ-receiving bag 1 or taken out from the organ-receiving bag 1 through the opened opening 20 .

The organ-accommodating bag 1 of this embodiment can also be used in a transplantation operation performed in the same procedure as shown in FIG. Then, in steps S4 and S5 of FIG. 3, by covering the entire surface of the organ 9 with the heat insulating sheet 10, the temperature rise of the organ 9 can be suppressed, and damage to the organ 9 can be suppressed. In addition, since the heat insulating sheet 10 is bag-shaped, the edges of the heat insulating sheet 10 are less likely to interfere with the operation of the surgeon.

In particular, in the structure of this embodiment, after the organ 9 is inserted into the organ-receiving bag 1 , the opening 20 of the organ-receiving bag 1 automatically closes due to the contractile force of the elastic member 40 . Therefore, unlike the first embodiment, it is not necessary to pull the operating string 30 to close the opening 20 . Therefore, the transplant operation can be performed more quickly. Further, similarly to the first embodiment, opening and closing operations of the opening 20 are less likely to damage the internal organs 9 .

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

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

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

The organ-accommodating bag 1 of this embodiment can also be used in a transplantation operation performed in the same procedure as shown in FIG. Then, in steps S4 and S5 of FIG. 3, by covering the entire surface of the organ 9 with the heat insulating sheet 10, the temperature rise of the organ 9 can be suppressed, and damage to the organ 9 can be suppressed. In addition, since the heat insulating sheet 10 is bag-shaped, the edges of the heat insulating sheet 10 are less likely to interfere with the operation of the surgeon.

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

As shown in FIG. 6, the organ-accommodating bag 1 of the fourth embodiment has a zipper 60 as an opening/closing member. Zipper 60 has a pair of zip members (fasteners) 61 provided in opening 20 . A pair of zip members 61 has minute concave and convex portions 62 that fit together. When the pair of zip members 61 are brought into contact with each other and pressure is applied, 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 to fix the zip members 61 together. . As a result, the opening 20 is closed. Further, when the pair of zip members 61 are pulled apart from each other, the fitting of the concave and convex portions 62 is released and the opening 20 is opened.

The organ-accommodating bag 1 of this embodiment can also be used in a transplantation operation performed in the same procedure as shown in FIG. Then, in steps S4 and S5 of FIG. 3, by covering the entire surface of the organ 9 with the heat insulating sheet 10, the temperature rise of the organ 9 can be suppressed, and damage to the organ 9 can be suppressed. In addition, since the heat insulating sheet 10 is bag-shaped, the edges of the heat insulating sheet 10 are less likely to interfere with the operation of the surgeon.

<5. Fifth Embodiment>
FIG. 7 is an exploded view of the organ-accommodating bag 1 according to the fifth embodiment. The organ-accommodating bag 1 of this embodiment differs from the above-described first embodiment in the shape of the heat insulating sheet 10 and the structure of the opening/closing member.

As shown in FIG. 7, the organ-accommodating bag 1 of the fifth embodiment is formed into a bag-like shape by folding one flat heat-insulating sheet 10. As shown in FIG. The heat insulating sheet 10 has a first piece 14 and a second piece 15 which are symmetrical about the folding line 13 as an axis of symmetry. Moreover, the organ-accommodating bag 1 of this embodiment has a hook-and-loop fastener 70 as an opening/closing member. The hook-and-loop 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 along the folding line 13, the engaging member 71 of the first piece 14 and the engaging member 71 of the second piece 15 come into contact with each other.

That is, the organ-accommodating bag 1 has a plurality of pairs of engaging members 71 that come into contact with each other when the insulating sheet 10 is folded along the fold line 13 . One of the pair of engaging members 71 contacting each other has a large number of fine hooks. The other of the pair of engaging members 71 that contact each other has a large number of fine loops with which hooks can engage. Therefore, when the pair of engaging members 71 come into contact, the two engaging members 71 are fixed to each other by the hook and loop engagement. As a result, the heat insulating sheet 10 is maintained in a bag shape and the opening 20 is partially closed. Further, 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.

The organ-accommodating bag 1 of this embodiment can also be used in a transplantation operation performed in the same procedure as shown in FIG. Then, in steps S4 and S5 of FIG. 3, by covering the entire surface of the organ 9 with the heat insulating sheet 10, the temperature rise of the organ 9 can be suppressed, and damage to the organ 9 can be suppressed. In addition, since the heat insulating sheet 10 is bag-shaped, the edges of the heat insulating sheet 10 are less likely to interfere with the operation of the surgeon.

In particular, in the structure of this embodiment, the opening 20 can be opened wide until the heat insulating sheet 10 is in a flat state. Therefore, the operation of inserting the organ 9 into the organ-receiving bag 1 and removing the organ 9 from the organ-receiving bag 1 can be easily performed. Moreover, there is little risk of damaging the organ 9 when inserting the organ 9 into the organ-receiving bag 1 and removing the organ 9 from the organ-receiving bag 1 .

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

As shown in FIG. 8, the organ-accommodating bag 1 of the sixth embodiment is formed into a bag shape by folding one flat heat insulating sheet 10. As shown in FIG. The heat insulating sheet 10 has a first piece 14 and a second piece 15 which are symmetrical about the folding line 13 as an axis of symmetry. Moreover, the organ-accommodating bag 1 of this embodiment has a snap button 80 as an opening/closing member. Snap button 80 has a plurality of buttons (fasteners) 81 provided on first piece 14 and second piece 15 . When the insulating sheet 10 is folded along the folding 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-accommodating bag 1 has a plurality of pairs of buttons 81 that come into contact with each other when the insulating sheet 10 is folded along the folding line 13 . One of the pair of buttons 81 that come into contact with each other is a male button having a convex portion. The other of the pair of buttons 81 that contact each other is a female button having a recess. Therefore, when the pair of buttons 81 are brought into contact with each other and pressure is applied, the two buttons 81 are fixed to each other due to the engagement between the convex portion and the concave portion. As a result, the heat insulating sheet 10 is maintained in a bag shape and the opening 20 is partially closed. Further, when the pair of buttons 81 are pulled apart from each other, the engagement between the buttons 81 is released and the opening 20 is opened.

The organ-accommodating bag 1 of this embodiment can also be used in a transplantation operation performed in the same procedure as shown in FIG. Then, in steps S4 and S5 of FIG. 3, by covering the entire surface of the organ 9 with the heat insulating sheet 10, the temperature rise of the organ 9 can be suppressed, and damage to the organ 9 can be suppressed. In addition, since the heat insulating sheet 10 is bag-shaped, the edges of the heat insulating sheet 10 are less likely to interfere with the operation of the surgeon.

In particular, in the structure of this embodiment, the opening 20 can be opened wide until the heat insulating sheet 10 is in a flat state. Therefore, the operation of inserting the organ 9 into the organ-receiving bag 1 and removing the organ 9 from the organ-receiving bag 1 can be easily performed. Moreover, there is little risk of damaging the organ 9 when inserting the organ 9 into the organ-receiving bag 1 and removing the organ 9 from the organ-receiving bag 1 .

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

Even if the organ-receiving bag 1 itself is not provided with an opening/closing member as in the present embodiment, the opening 20 of the organ-receiving bag 1 can be closed by using a separate fixing member such as a clip or tape. can. Moreover, the opening 20 of the organ-accommodating bag 1 can be opened by removing the fixing member.

The organ-accommodating bag 1 of this embodiment can also be used in a transplantation operation performed in the same procedure as shown in FIG. Then, in steps S4 and S5 of FIG. 3, by covering the entire surface of the organ 9 with the heat insulating sheet 10, the temperature rise of the organ 9 can be suppressed, and damage to the organ 9 can be suppressed. In addition, since the heat insulating sheet 10 is bag-shaped, the edges of the heat insulating sheet 10 are less likely to interfere with the operation of the surgeon.

<8. Eighth Embodiment>
FIG. 10 is an external view of the organ-accommodating bag 1 according to the eighth embodiment. The organ-accommodating bag 1 of this embodiment differs from the above-described first embodiment in that a waterproof inner bag 90 is provided inside the bag-like heat insulating sheet 10 .

The inner bag 90 is made of a material that is flexibly deformable, waterproof, biocompatible, and sterilization-retentive. Specifically, as the material of the inner bag 90, polyvinylidene fluoride, silicon resin, polyurethane, fluororesin, fluororubber, urethane rubber, vinyl chloride, nylon, polyethylene, or polyurethane elastomer can be used. In addition, the inner bag 90 is formed of one seamless film and can hold liquid inside.

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

The organ-accommodating bag 1 of this embodiment can also be used in a transplantation operation performed in the same procedure as shown in FIG. In particular, in this embodiment, a low-temperature storage solution can be placed inside the inner bag 90 together with the organ 9 . Further, it is also possible to additionally pour a low-temperature preservation liquid into the inner bag 90 during step S5 in FIG. Thereby, the temperature rise of the internal organ 9 can be suppressed more.

In addition, in the structure of the fifth embodiment and the sixth embodiment, 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 each provided with an inner bag. Bag 90 may be fixed. Also, the inner bag 90 on the first piece 14 side and the inner bag 90 on the second piece 14 side may be connected near the fold line 13 .

Moreover, the organ-accommodating bag 1 may have a waterproof outer bag outside the bag-shaped heat insulating sheet 10 . The same material as the inner bag 90 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 can be applied not only to the structures of the first to fourth and seventh embodiments, but also to the fifth and sixth embodiments. can be done.

<9. Experimental example>
FIG. 11 is a graph showing changes in the temperature of kidneys excised from pigs, preserved in a preservation solution at 4° C. for 24 hours, and then placed in an environment at 37° C. (simulated intraperitoneal cavity). . A polygonal line C1 in the graph indicates the change in temperature of the kidney when it is not housed in the organ bag (Case 1). A polygonal line C2 in the graph indicates the change in temperature of the kidney when it is housed in the organ bag (Case 2). The experiment was performed twice for Case 1 and Case 2, respectively. Lines C1 and C2 in FIG. 11 each indicate the average value of the two results.

From the results of FIG. 11, the kidney accommodated in the organ-accommodating bag suppresses the temperature rise in the pseudo-abdominal cavity more than the kidney that is not accommodated in the organ-accommodating bag. Therefore, it can be seen that the temperature rise of the organ during the transplant operation can be suppressed by using the organ-accommodating bag. In particular, the average time required for vascular anastomosis is about 30 minutes, but according to the results of FIG. In contrast, in case 2, the kidney temperature is suppressed to 30°. This 5° temperature difference has a great influence on the progress of metabolism in the kidney. That is, it can be said that the use of the organ-accommodating bag can significantly suppress the progress of metabolism in the organ.

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

<10. Variation>
Although the main embodiments of the present invention have been described above, the present invention is not limited to the above embodiments.

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 vapor-deposited can be used. In this way, radiation such as near-infrared rays traveling from the recipient's body to the organ 9 is reflected by the metal film. Therefore, it is possible to further suppress the temperature rise of the organ 9 accommodated in the organ-accommodating bag 1 .

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

Further, the detailed structure of the organ-accommodating bag may not completely match the structure shown in each drawing of the present application. Also, the elements appearing in the above-described first to eighth embodiments and modifications may be appropriately combined within a range that does not cause contradiction.

1 organ storage bag 9 organ 10 heat insulating sheet 11 heat insulating layer 12 waterproof layer 13 folding line 14 first piece 15 second piece 20 opening 21 insertion hole 30 operation string 40 elastic member 50 line fastener 51 row of teeth 52 slider 60 zipper 61 Zip member 62 Concavo-convex portion 70 Hook-and-loop fastener 71 Engagement member 80 Snap button 81 Button 90 Inner bag 91 Blood vessel

Claims (10)

An organ storage bag for storing an organ,
an opening through which an organ can pass;
a bag-shaped heat insulating sheet for holding the organ inserted through the opening;
A waterproof inner bag provided inside the heat insulating sheet;
with
The heat insulating sheet is
a pair of waterproof layers;
a heat insulating layer positioned between the pair of waterproof layers;
an organ-containing bag. An organ storage bag for storing an organ,
an opening through which an organ can pass;
a bag-shaped heat insulating sheet for holding the organ inserted through the opening;
A waterproof outer bag provided outside the heat insulating sheet;
with
The heat insulating sheet is
a pair of waterproof layers;
a heat insulating layer positioned between the pair of waterproof layers;
an organ-containing bag. The organ-accommodating bag according to claim 1 or 2,
An opening/closing member that at least partially opens/closes the opening
an organ-accommodating bag, further comprising: The organ-accommodating bag according to claim 3,
The organ storage bag, wherein the opening/closing member is an operation string that contracts the opening. The organ-accommodating bag according to claim 3,
The organ-receiving bag, wherein the opening/closing member is a stretchable elastic member provided in the opening. The organ-accommodating bag according to claim 3,
The opening/closing member has a pair of fasteners that can be fixed and separated from each other. The organ-accommodating bag according to any one of claims 1 to 6,
The heat insulating layer is made of polyethylene foam, polystyrene foam, flexible urethane foam, polystyrene, or non-woven fabric,
The organ-receiving bag, wherein the waterproof layer is made of polyvinylidene fluoride, silicone resin, polyurethane, fluororesin, fluororubber, urethane rubber, vinyl chloride, nylon, polyethylene, or polyurethane elastomer. A transplantation method for transplanting an organ removed from a non-human animal donor to a non-human animal recipient, comprising:
a) housing the organ in an organ-receiving bag;
b) after step a), placing the organ-receiving bag containing the organ in the body cavity of the recipient;
c) after step b), anastomosing the vessel of the recipient and the vessel of the organ;
d) removing the organ from the organ-receiving bag and removing the organ-receiving bag after step c);
has
The organ storage bag is
an opening through which an organ can pass;
a bag-shaped heat insulating sheet for holding the organ inserted through the opening;
A waterproof inner bag provided inside the insulating sheet
A method of transplantation comprising: A transplantation method for transplanting an organ removed from a non-human animal donor to a non-human animal recipient,
a) housing the organ in an organ -receiving bag;
b) after step a), placing the organ-receiving bag containing the organ in the body cavity of the recipient;
c) after step b), anastomosing the vessel of the recipient and the vessel of the organ;
d) removing the organ from the organ-receiving bag and removing the organ-receiving bag after step c);
has
The organ storage bag is
an opening through which an organ can pass;
a bag-shaped heat insulating sheet for holding the organ inserted through the opening;
A waterproof outer bag provided outside the heat insulating sheet
A method of transplantation comprising : The transplantation method according to claim 8 or claim 9,
The heat insulating sheet is
a pair of waterproof layers;
a heat insulating layer positioned between the pair of waterproof layers;
A method of transplantation.

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