Patent Description:
In organ transplant operations, an organ removed from a donor is preserved under cooled conditions. This is because if the organ is left at ordinary temperature and the bloodstream in the organ is stopped, i.e., the organ gets into a so-called warm ischemic state, the organ becomes easy to deteriorate due to metabolism in the organ. Specifically, the temperature of the organ is kept low through procedures such as pouring a low-temperature preservation solution into the isolated organ or directly spraying ice-slush saline around the organ. This suppresses organ metabolism.

However, at the time of transplanting an organ into a recipient, the organ is placed in the body cavity of the recipient and undergoes procedures such as vascular anastomosis. At this time, the organ cannot be kept under cooled conditions, so that the temperature of the organ rises due to the body temperature of the recipient or the outside air temperature and the organ gradually gets into a warm ischemic state. Hence, the surgeon carrying out the transplant operation has to maintain low-temperature conditions of the organ to be transplanted, by, for example, performing procedures such as vascular anastomosis in a time as short as possible or pouring ice or other materials into the abdominal cavity. In the latter case, not only the organ but also the fingertips of the surgeon will be cooled at the same time, and this is disadvantageous for vascular anastomosis that requires high precision.

In view of this, the inventors of the present application have proposed a technique described in <CIT>, in which at the time of transplanting an organ into a recipient, a sheet having a heat insulating function is inserted between the recipient and the organ to suppress a temperature rise in the organ. The sheet according to <CIT> includes a heat insulating membrane and two waterproofing membranes that are face-bonded to the opposite sides of the heat insulating membrane.

However, the sheet according to <CIT> does not completely cover the organ. Thus, there is a problem that a temperature rise occurs in the portion of the surface of the organ that is not covered with the sheet. Besides, end sections of the sheet inserted between the recipient and the organ may hinder the work of the surgeon.

<CIT> discloses an intraoperative protective kidney bag, which includes a protective bag body having a sandwich structure for storing a cold storage material and wherein the inner wall is provided with inner folds.

Further prior art documents are <CIT> and <CIT>.

It is an object of the present invention to provide a medical appliance that further suppresses a temperature rise in an organ and is less likely to hinder the work of a surgeon at the time of transplanting the organ into a recipient. This object is achieved by the subject-matter of claim <NUM>. Further advantageous embodiments of the invention are the subject-matter of the dependent claims. Aspects of the invention are set out below.

A first aspect of the present application is an organ container for accommodating an organ. The organ container includes a pouch-shaped body having contraction and expansion properties and an opening. In a no-load condition, a maximum width of the opening is less than a maximum width of the body. The opening is expandable to a state in which the maximum width of the opening becomes greater than the maximum width of the body.

According to the first aspect of the present application, the organ container covers the surface of an organ along the surface of the organ. Thus, when the organ is placed in the body cavity of the recipient, the organ container does not expand around the organ. Accordingly, the organ container is less likely to hinder work during operation. Moreover, the organ container covers most part of the organ and thereby suppresses a temperature rise in the organ.

An embodiment of the present invention will be described hereinafter with reference to the drawings.

In the present application, "donors" and "recipients" may be humans, or may be non-human animals. That is, "organs" according to the present application may be human organs, or may be organs of non-human animals. The non-human animals may be rodents such as mice and rats, ungulates such as pigs, goats, and sheep, non-human primates such as chimpanzees, or other non-human mammals, or may be nonmammalian animals.

<FIG> is a perspective view of an organ container <NUM> according to a first embodiment. <FIG> is a top view of the organ container <NUM>. <FIG> is a sectional view of the organ container <NUM>. This organ container <NUM> is a container for temporarily accommodating an organ removed from a donor in a transplant operation for transplanting the organ into the recipient. That is, the organ container <NUM> is a medical appliance for use in organ transplant operations.

Examples of the organ that can be accommodated in the organ container <NUM> include a kidney, a heart, and a lung. Blood vessels of these organs that are to be anastomosed in transplant operations are concentrated on one side of the organs. The structure of the organ container <NUM> according to the present embodiment is particularly suitable for these organs. However, the organ container according to the present invention may be configured to accommodate other organs such as a liver.

In the following description, the up-down direction is defined such that the side of the organ container <NUM> with an opening <NUM> is considered as the upper side and the bottom side of the organ container <NUM> opposite to the opening <NUM> is considered as the lower side. In the following description, the up-down direction is also referred to as a z direction, a direction along the long sides of the organ container <NUM> when viewed in the z direction is referred to as an x direction, and a direction along the short sides of the organ container <NUM> when viewed in the z direction is referred to as a y direction, as illustrated in <FIG>. Note that the definition of the up-down direction does not intend to limit the orientation of the organ container <NUM> during use.

As illustrated in <FIG>, the organ container <NUM> includes a pouch-shaped body <NUM> with contraction and expansion properties. The body <NUM> has an opening <NUM> and a thick part <NUM>. The opening <NUM> communicates between the inside of the body <NUM> and an exterior space. The thick part <NUM> surrounds the opening <NUM> in a ring shape.

The organ container <NUM> according to the present embodiment as a whole is generally an ellipsoid. That is, the body <NUM> has generally an ellipsoidal shape. This organ container <NUM> is, in particular, configured to accommodate a kidney. The organ container <NUM> as a whole is made in generally an ellipsoidal shape so that the inner surface of the body <NUM> has a shape that easily fits along the surface of a kidney.

To describe the relation of dimensions, in the following description, a length of the body <NUM> in the direction along the long sides (x direction) is referred to as a length D1, a length of the body <NUM> in the direction along the short sides (y direction) is referred to as a length D2, and a length of the body <NUM> in the up-down direction (z direction) is referred to as a length D3, as illustrated in <FIG> and <FIG>.

The body <NUM> is formed of an elastomer gel. Specifically, the body <NUM> is formed of a thermoplastic elastomer, an urethane elastomer, or an oil bleeding silicone gel. The body <NUM> has a hardness of, for example, E10 to A10 according to a durometer hardness test that complies with Japanese Industrial Standards JIS K <NUM>-<NUM>:<NUM>. An elongation percentage at break for the body <NUM> is higher than or equal to <NUM>%.

Forming the body <NUM> of such a material makes the body <NUM> and the opening <NUM> easy to expand and less likely to break. Forming the body <NUM> of such a material also makes it possible to reduce the possibility that the temperature outside the body <NUM> propagates to the organ in the body <NUM> at the time of accommodating the organ in the body <NUM>.

The opening <NUM> is an opening for inserting an organ into the internal space of the body <NUM>. The opening <NUM> also plays a role as a connection port for connecting blood vessels or other pathways connected to the organ to the outside while the organ is accommodated in the body <NUM>.

In the present embodiment, the opening <NUM> has an elliptical shape. In a no-load condition in which no artificial loads are imposed on the organ container <NUM>, a length of the opening <NUM> along the major axis is referred to as a length D4. The length D4, which is a maximum width of the opening <NUM> in a no-load condition, is shorter than the length D1, which is a maximum width of the body <NUM>.

The thick part <NUM> is a partial area that is greater in thickness than the surrounding area. With increasing thickness, the elastomer gel, which forms the body <NUM>, has a higher capability to contract in a direction returning to its original state against loads applied in the direction of expansion. Thus, surrounding the opening <NUM> in a ring shape by the thick part <NUM> makes it possible to increase an elastically deformable amount of the area around the opening <NUM> and to improve strength around the opening <NUM>. That is, it is possible, at the time of expanding the opening <NUM>, to suppress plastic deformation around the opening <NUM> and breakage of the opening <NUM>.

Besides, at the time of accommodating the organ inside, the thick part <NUM> comes in intimate contact with the organ. This suppresses a protrusion of the organ from the opening <NUM> and suppresses an outflow of a liquid held between the organ and the body <NUM> from the opening <NUM>.

The inner surface of the body <NUM> has an uneven shape. Specifically, as illustrated in <FIG>, the inner surface of the body <NUM> has a plurality of projections <NUM> that project toward the internal space of the body <NUM>. The projections <NUM> extend in the up-down direction from the opening <NUM> toward the bottom of the body <NUM>. Accordingly, a groove <NUM> is formed between each pair of adjacent projections <NUM>. That is, the inner surface of the body <NUM> has a plurality of grooves <NUM> extending in the up-down direction.

This uneven inner surface of the body <NUM> allows a preservation solution for cooling to be held in the interstices between the organ and depressions in the inner surface of the body <NUM> when the organ is accommodated in the body <NUM>. In particular, in the case where the inner surface of the body <NUM> has a plurality of grooves <NUM> extending in the up-down direction as in the present embodiment, the preservation solution for cooling poured inside from the opening <NUM> can easily reach the bottom side. That is, the preservation solution for cooling, held between the organ and the inner surface of the body <NUM>, is likely to spread across the inner surface.

<FIG> are diagrams illustrating how a kidney <NUM>, which is one example of the organ, is accommodated in the organ container <NUM>. Specifically, <FIG> is a diagram illustrating the kidney <NUM> and the organ container <NUM> that is in a no-load condition side by side. <FIG> is a diagram illustrating that the opening <NUM> of the organ container <NUM> is expanded in order to accommodate the kidney <NUM>. <FIG> is a diagram illustrating that the kidney <NUM> is accommodated in the organ container <NUM>.

As illustrated in <FIG>, in a no-load condition, the length D1, which is the maximum width of the body <NUM> of the organ container <NUM>, is shorter than a maximum width of the kidney <NUM>, i.e., a length K1. That is, in a no-load condition, a maximum width of the inner surface of the body <NUM>, i.e., a length D5, is shorter than the length K1, which is the maximum width of the kidney <NUM>. Thus, the length D4, which is the maximum width of the opening <NUM> in a no-load condition, is shorter than the length K1, which is the maximum width of the kidney <NUM>.

The opening <NUM> is expandable to a state in which the maximum width of the opening <NUM> becomes greater than the length D1, which is the maximum width of the body <NUM> in a no-load condition. Thus, the kidney <NUM> can be easily accommodated in the body <NUM>. In <FIG>, a state is illustrated in which the opening <NUM> is expanded until the maximum width of the opening <NUM> becomes a length D6 longer than the length D1. In this way, the operator expands the opening <NUM> to accommodate the kidney <NUM> in the body <NUM> through the opening <NUM>. In the organ container <NUM> according to the present embodiment, the opening <NUM> can be expanded to a state in which the maximum width of the opening <NUM> becomes greater than the length K1, which is the maximum width of the kidney <NUM>. Therefore, the kidney <NUM> can be more easily accommodated in the body <NUM>.

Then, when the kidney <NUM> is accommodated in the body <NUM> as illustrated in <FIG>, the entire inner surface of the body <NUM> including the periphery of the opening <NUM> fits along the surface of the kidney <NUM>. As described above, in a no-load condition, the inner surface of the body <NUM> is smaller than the outer surface of the kidney <NUM>. Thus, when the kidney <NUM> is accommodated in the organ container <NUM>, the inner surface of the body <NUM> fits along the outer surface of the kidney <NUM>, and the projections <NUM> on the inner surface of the body <NUM> come in intimate contact with the outer surface of the kidney <NUM>. Accordingly, the kidney <NUM> is appropriately held without being moved inside the body <NUM>. As a result, it is possible to suppress damage to the kidney <NUM>.

Next, a procedure for a transplant operation using the above-described organ container <NUM> will be described. <FIG> is a flowchart illustrating the procedure for the transplant operation using the organ container <NUM>. The following description is given of the case where the kidney <NUM> is to be transplanted using the organ container <NUM>.

In the transplant operation, first the kidney <NUM> is removed from a donor (step S1). Specifically, blood vessels <NUM> and <NUM> and an ureter <NUM> that extend from the kidney <NUM> of the donor (see <FIG>) are cut, and the kidney <NUM> is taken out of the body cavity of the donor.

The removed kidney <NUM> is preserved while being immersed in a low-temperature preservation solution. The kidney <NUM> is also accommodated in the organ container <NUM> (step S2). For example, saline kept at <NUM> is used as the preservation solution. If the organ is left at ordinary temperature and the bloodstream in the organ is stopped, i.e., the organ gets into a so-called warm ischemic state, the organ becomes easy to deteriorate due to metabolism in the organ. Thus, in step S2, the kidney <NUM> is preserved at a temperature lower than ordinary temperature so as to suppress deterioration of the kidney <NUM>.

Alternatively, in step S2, tubes may be connected to the blood vessels <NUM> and <NUM> of the kidney <NUM>, and the kidney <NUM> may be preserved while being perfused with a preservation solution. Note that the perfusion using the preservation solution may continue until step S4 described later.

The timing when the kidney <NUM> is accommodated in the organ container <NUM> may be before the kidney <NUM> is immersed in the preservation solution, or may be after the kidney <NUM> is immersed in the preservation solution for a while and sufficiently cooled. When the kidney <NUM> is accommodated in the organ container <NUM>, the opening <NUM> of the organ container <NUM> is opened, and the kidney <NUM> is inserted through the opening <NUM> into the body <NUM> as illustrated in <FIG>. Accordingly, the kidney <NUM> is held inside the pouch-shaped body <NUM> as illustrated in <FIG>. At this time, a low-temperature preservation solution is poured into the space between the kidney <NUM> and the inner surface of the body <NUM>, using a syringe or a pipette. Also, the kidney <NUM> embraced by the organ container <NUM> is immersed again in a low-temperature preservation solution to maintain a low-temperature preservation condition.

The kidney <NUM> held by the organ container <NUM> is transported from the donor side to the recipient side while being immersed in the low-temperature preservation solution (step S3). The kidney <NUM> transported to the recipient side continues to be held by the organ container <NUM> and to be immersed in the low-temperature preservation solution until just before transplantation.

Then, the abdomen of the recipient is opened, and the organ container <NUM> accommodating the kidney <NUM> therein is placed in the body cavity of the recipient (step S4). Then, the blood vessels of the recipient are anastomosed to the blood vessels <NUM> and <NUM> of the kidney <NUM> exposed to the outside through the opening <NUM> of the organ container <NUM> (step S5). In the case where the organ to be transplanted is the kidney <NUM>, the ureter <NUM> is also connected to the urinary bladder.

During the work in steps S4 and S5, the kidney <NUM> accommodated in the organ container <NUM> is placed within the body cavity. At this time, since the organ container <NUM> has a thermal insulating function, it is possible to suppress a temperature rise in the kidney <NUM> due to the body temperature of the recipient or the outside air temperature. This reduces the possibility that the kidney <NUM> gets into a warm ischemic state and its deterioration progresses due to metabolism. As a result, it is possible to suppress the occurrence of troubles after operation.

In steps S4 and S5, a low-temperature preservation solution is poured at regular time intervals into the organ container <NUM>, using a syringe or a pipette. For example, a low-temperature preservation solution is poured every few minutes into the organ container <NUM>. This further suppresses a temperature rise in the kidney <NUM>.

Thereafter, the opening <NUM> of the organ container <NUM> is opened, and the kidney <NUM> that has undergone vascular anastomosis is taken out of the organ container <NUM>. Then, the organ container <NUM> is removed from the body cavity of the recipient (step S6). Thereafter, the bloodstream from the anastomosed blood vessels of the recipient to the kidney <NUM> is resumed (step S7).

This organ container <NUM> covers the surface of the kidney <NUM> along the surface of the kidney <NUM>. Thus, part of the organ container <NUM> does not expand around the kidney <NUM>. For example, end sections or the like of the organ container <NUM> do not expand around the kidney <NUM>. Accordingly, the organ container <NUM> is less likely to hinder work during operation. Moreover, the organ container <NUM> covers most part of the surface of the kidney <NUM> and thereby further suppresses a temperature rise in the kidney <NUM> and prevents damage to the surface of the kidney <NUM> during operation.

This organ container <NUM> is formed of a raw material having elasticity. Thus, the organ container <NUM> can absorb impacts on the kidney <NUM> during transport or during operation. Accordingly, it is possible to suppress damage to the kidney <NUM>.

While a principal embodiment of the present invention has been described thus far, the present invention is not intended to be limited to the embodiment described above.

<FIG> is a sectional view of an organ container 1A according to a variation. <FIG> is a sectional view of an organ container 1B according to another variation. In <FIG> and <FIG>, uneven shapes of the inner surfaces of bodies 20A and 20B are not illustrated.

In the organ container <NUM> according to the above-described embodiment, the thick part <NUM> is greater in thickness than the surrounding area as a result of protruding toward the outer surface of the body <NUM> without protruding toward the inner surface of the body <NUM>. In contrast, in the organ container 1A in the example illustrated in <FIG>, a thick part 40A has a generally circular sectional shape. Thus, the thick part 40A protrudes toward both of the inner and outer surfaces of the body 20A. In the organ container 1B in the example illustrated in <FIG>, a thick part 40B protrudes toward the inner surface of the body 20B without protruding toward the outer surface of the body 20B.

As in the examples in <FIG> and <FIG>, the thick part may protrude toward both of the inner and outer surfaces of the body. The shape of the thick part may be appropriately changed.

<FIG> is a sectional view of an organ container 1C according to another variation. As in <FIG> and <FIG>, an uneven shape of the inner surface of the body 20C is not illustrated in <FIG>. The organ container <NUM> according to the above-described embodiment includes one opening <NUM> and is thus suitable for organs such as a kidney, a heart, or a lung in which blood vessels to be anastomosed during transplant operations are concentrated on one side of the organs.

In contrast, a body 20C of the organ container 1C in the example illustrated in <FIG> has two openings 30C. Thus, the organ container 1C is suitable for organs such as a liver, a pancreas, or a spleen in which blood vessels to be anastomosed during transplant operations extend in multiple directions. As described above, the number of openings in the body is not limited to one. In the case where the body has a plurality of openings, these openings do not necessarily have to be of the same size. An opening through which a blood vessel passes may be smaller than an opening for accommodating an organ.

<FIG> is a sectional view of an organ container 1D according to another variation, not forming part of the claimed invention. In the organ container 1D illustrated in <FIG>, the inner surface of a body 20D has a plurality of projections 41D that extend in a direction orthogonal to the up-down direction. Accordingly, a groove 50D is formed between each pair of adjacent projections 41D. That is, the inner surface of the body 20D has a plurality of grooves 50D extending in the direction orthogonal to the up-down direction.

In accordance with the invention, the grooves formed in the inner surface of the body extend in the up-down direction. In a variation that does not fall under the claimed invention, the direction of extension of the grooves may be a direction orthogonal to the up-down direction as in the example illustrated in <FIG>.

In another alternative that does not fall under the claimed invention, the grooves may be formed in, for example, a spiral shape in the inner surface of the body. As another alternative that does not fall under the claimed invention, a configuration is also possible in which the grooves include a plurality of first grooves that extend generally parallel to one another in a predetermined direction, and a plurality of second grooves that extend generally parallel to one another in a predetermined direction different from the direction of extension of the first grooves, and at least some of the first grooves and at least some of the second grooves intersect with one another in lattice form. In variations that do not fall under the claimed invention, the uneven shape of the inner surface of the body is not limited to projections and grooves, both extending in a predetermined direction. For example, the inner surface of the body may have projections or depressions of indefinite shape that are arranged at random intervals.

In the above-described embodiment, the body <NUM> of the organ container <NUM> is formed of a single type of material, but the present invention is not limited thereto. For example, the body <NUM> may be configured of a plurality of layers formed of different materials. For example, a layer that is close to the outer surface of the body may have a greater durometer hardness value than a layer that forms the inner surface of the body that comes in contact with an organ. Also, a coating may be applied to the outer surface of the body in order to prevent external damage.

A detailed structure of the organ container does not necessarily have to match completely with the structure illustrated in each drawing of the present application.

Claim 1:
An organ container (<NUM>) for accommodating an organ, comprising:
a pouch-shaped body (<NUM>) having an opening (<NUM>),
wherein said body (<NUM>) has a ring-shaped thick part (<NUM>) that surrounds said opening (<NUM>), said body (<NUM>) has a hardness of E10 to A10 according to a durometer hardness test that complies with Japanese Industrial Standards JIS K <NUM>-<NUM>:<NUM>,
said thick part (<NUM>) is a partial area that is greater in thickness than the surrounding area such that said thick part (<NUM>) is adapted to increase an elastically deformable amount of the area around the opening (<NUM>) and to improve strength around the opening (<NUM>),
wherein in a no-load condition, a maximum width of said opening (<NUM>) is less than a maximum width of said body (<NUM>),
said opening (<NUM>) is expandable to a state in which the maximum width of said opening (<NUM>) becomes greater than the maximum width of said body (<NUM>) in a no-load condition,
and wherein an inner surface of the body (<NUM>) has a plurality of grooves (<NUM>) extending in the up-down direction from the opening (<NUM>) toward the bottom of the body (<NUM>).