Transplanting device, and method for manufacturing a transplanting device

Abstract

To provide a transplanting device that suppresses disengagement of the transplant from the living body on an arrangement of the transplant in a living body, and thereby can increase the efficiency of the arrangement of the transplant, and provide a method for manufacturing the transplanting device.SOLUTION: A transplanting device 10 includes a needle-shaped part 20 having a shape capable of stabbing a living body, the needle-shaped part 20 that is structured to internally hold a transplant 50 containing a cell group. In the material of the needle-shaped part 20, a water-soluble material and an oiliness material are contained. The water-soluble material contains a water-soluble polymer. The oiliness material contains vegetable oil-and-fat, animal fats, mineral oil, and at least one of the oil-and-fat synthesized by using these as a raw material.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to an implant used for transplanting a cell group into a living body and a method for manufacturing the implant.

Background Art

[0002] The utilization of techniques for transplanting a cell group into a living body has been progressing. For example, attempts have been made to regenerate hair by culturing a cell group that contributes to the formation of a hair follicle organ that produces hair and transplanting this cell group onto the skin (see, for example, Patent Documents 1 to 3).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0004] When placing a cell group in a living body, the cell group is held with an instrument such as forceps or a syringe, the surface of the living tissue is cut, and the instrument is inserted into the tissue. Then, after the cell group is placed, the instrument is pulled out from the tissue. However, in such a method for transplanting a cell group, when the instrument is pulled out from the tissue, the cell group may come out of the tissue together with the instrument in some cases, which causes a decrease in the transplantation efficiency.

Means for Solving the Problems

[0005] A transplanter for solving the above problems comprises a needle-shaped portion having a shape that can pierce a living organism, and configured to hold a transplant containing a group of cells inside, wherein the material of the needle-shaped portion includes a water-soluble material and an oil-soluble material.

[0006] With the above configuration, the graft is inserted into the body while being held by the needle-shaped portion, and is positioned within the body as the needle-shaped portion dissolves. Therefore, compared to cases where instruments such as tweezers are inserted into and withdrawn from the body during transplantation, the risk of the graft coming out of the body is suppressed. Consequently, the efficiency of graft placement is increased, and it becomes easier to control the depth of placement of the graft within the body's tissue to a desired depth. Furthermore, since the needle-shaped portion contains an oily material in addition to a water-soluble material, the rate of dissolution of the needle-shaped portion can be slowed down overall or partially compared to cases where the needle-shaped portion consists only of a water-soluble material.

[0007] In the above configuration, the water-soluble material includes a water-soluble polymer, and the oily material may include at least one of vegetable oils, animal oils, mineral oils, and oils synthesized using these as raw materials.

[0008] According to the above configuration, needle-shaped portions that dissolve in living organisms are suitably formed. Furthermore, it is possible to precisely slow down the dissolution rate of the needle-shaped portions, either overall or partially.

[0009] In the above configuration, the proportion of the oily material in the needle-shaped portion may be 60% by mass or less. According to the above configuration, the needle-like portion can be obtained with appropriate strength. Furthermore, it becomes easy to form the needle-like portion into a desired shape by mixing water-soluble and oil-soluble materials. In the above configuration, the water-soluble material and the oil-based material may be uniformly mixed in the needle-shaped portion.

[0010] According to the above configuration, the rapid dissolution of the needle-shaped portion can be suppressed throughout the entire structure. Therefore, in the initial stages after the needle-shaped portion enters the body, its shape is more easily maintained, making it easier for the needle-shaped portion to penetrate to the desired depth. Consequently, the graft can be more easily positioned at the desired depth.

[0011] In the above configuration, the material of the needle-shaped portion may contain a surfactant. According to the above configuration, even if the melting point of the oil-soluble material is high, the water-soluble material and the oil-soluble material become easier to mix.

[0012] In the above configuration, the concentration of the oily material in the needle-shaped portion may be uneven within the needle-shaped portion. According to the above configuration, the rate at which the needle-shaped portion dissolves can be partially slowed down.

[0013] In the above configuration, the needle-shaped portion may have a water-soluble portion containing the water-soluble material and an oily portion containing the oily material. According to the above configuration, needle-shaped portions with partially different concentrations of oily material can be suitably realized.

[0014] In the above configuration, the oily portion may be located on the surface of the needle-shaped portion. With the above configuration, the start of dissolution of the water-soluble portion can be delayed, so that the needle-shaped portion maintains a shape that is easily penetrated into the body in the initial stages after entering the body. Therefore, the needle-shaped portion can penetrate to the desired depth, making it easier for the graft to be positioned at the desired depth.

[0015] In the above configuration, the oily portion may be located at the base of the needle-shaped portion. According to the above configuration, the base of the needle-shaped part dissolves rapidly, making it difficult for the force pressing on the transplanter to be transmitted to the needle-shaped part, and also suppressing pressure on the transplanted material from the rapidly dissolving liquid base. In addition, because the shape of the base of the needle-shaped part is easily maintained, the position where the needle-shaped part is inserted becomes easier to see.

[0016] In the above configuration, the oily part may be located at the tip of the needle-like part. According to the above configuration, the shape of the tip of the needle-like part is likely to be maintained. Therefore, the needle-like part is likely to penetrate to a desired depth, and thus the implant is likely to be placed at the desired depth.

[0017] In the above configuration, the water-soluble part may have a hole for accommodating the implant, and the oily part may cover the inner surface of the hole. According to the above configuration, contact between the implant containing moisture and the water-soluble part is suppressed. Therefore, dissolution of the needle-like part from the inside before piercing the living body is suppressed.

[0018] In the above configuration, a substrate part for supporting the base end of the needle-like part is provided, and the material of the substrate part may include a water-soluble material and an oily material. According to the above configuration, when the substrate part contacts the surface of the living body, the substrate part dissolves. As a result, peeling of the substrate part from the surface of the living body becomes unnecessary, and thus the labor required for using the implantor is reduced. Further, since the substrate part contains an oily material, the dissolution rate of the substrate part can be adjusted.

[0019] In the above configuration, the ratio of the oily material in the substrate part may be different from the ratio of the oily material in the needle-like part. According to the above configuration, the dissolution rate of the substrate part can be made different from the dissolution rate of the needle-like part. Therefore, the order of dissolution of the needle-like part and the substrate part can be controlled.

[0020] In the above configuration, a plurality of the needle-like parts are provided, and the plurality of needle-like parts include a first needle-like part and a second needle-like part, and the ratio of the oily material in the first needle-like part may be different from the ratio of the oily material in the second needle-like part. According to the above configuration, the dissolution rate of the first needle-like part can be made different from the dissolution rate of the second needle-like part.

[0021] A method for manufacturing an implant for solving the above problems is a method for manufacturing an implant including a needle-shaped part having a shape capable of piercing a living body and configured to hold a graft containing a cell group inside, including forming the needle-shaped part by filling a recess of an intaglio plate having a recess corresponding to the shape of the needle-shaped part with a water-soluble material and an oily material.

[0022] According to the above manufacturing method, an implant including a needle-shaped part that holds a graft and dissolves in a living body can be manufactured. According to such an implant, since the graft is suppressed from coming out of the living body, the efficiency of arranging the graft is increased, and it becomes easier to control the depth of the graft arranged in the tissue of the living body to a desired depth. And since the needle-shaped part contains an oily material in addition to the water-soluble material, the melting speed of the needle-shaped part can be made slower overall or partially compared to the case where the needle-shaped part consists only of the water-soluble material.

[0023] In the above manufacturing method, the needle-shaped part may be formed by filling the recess with a liquid in which the water-soluble material and the oily material are mixed and solidifying the filling material. According to the above manufacturing method, a needle-shaped part can be formed that suppresses the rapid dissolution of the needle-shaped part throughout the whole.

Advantages of the Invention

[0024] According to the present invention, when arranging a graft in a living body, it is possible to suppress the detachment of the graft from the living body and increase the efficiency of arranging the graft.

Brief Description of the Drawings

[0025] [Figure 1] A diagram showing a cross-sectional structure of an implant in the first embodiment. [Figure 2] A diagram showing another example of the cross-sectional structure of an implant in the first embodiment. [Figure 3] A diagram showing a cross-sectional structure of an implant including a plurality of needle-shaped parts in the first embodiment. [Figure 4] A diagram showing a procedure for arranging a graft using the implant of the first embodiment. [Figure 5] A diagram showing the procedure for arranging grafts using the transplanter of the first embodiment. [Figure 6] A diagram showing the procedure for arranging grafts using the transplanter of the first embodiment. [Figure 7] A diagram showing the manufacturing process of the transplanter according to the first embodiment. [Figure 8] A diagram showing the manufacturing process of the transplanter according to the first embodiment. [Figure 9] A diagram showing the cross-sectional structure of the first example transplanter in the second embodiment. [Figure 10] A diagram showing the cross-sectional structure of the second example of a transplanter in the second embodiment. [Figure 11] A diagram showing the cross-sectional structure of the third example of a transplanter in the second embodiment. [Figure 12] A diagram showing the cross-sectional structure of the fourth example of the transplanter in the second embodiment. [Modes for carrying out the invention]

[0026] (First Embodiment) A first embodiment of the implantation device will be described with reference to Figures 1 to 8. The implantation device of this embodiment is used to place a graft, including a group of cells, into a living organism. The area in which the graft is placed is within the tissue of the living organism, for example, at least one of the intradermal and subcutaneous tissues, or an organ, etc. In this embodiment, "living organism" includes not only the body and tissues of an organism, but also living organism models, which are artificially manufactured products that mimic the body and tissues of an organism. That is, the implantation device of this embodiment can be used not only for placing grafts in living organisms, but also for placing grafts in living organism models.

[0027] [Structure of the transplanter] As shown in Figure 1, the transplanter 10 is equipped with a needle-shaped portion 20 that extends in a shape capable of piercing living organisms. The needle-shaped portion 20 holds the transplanted plant 50 inside. Furthermore, it is preferable that the transplanter 10 is equipped with a base portion 30 that supports the base end of the needle-shaped portion 20. The base portion 30 is plate-shaped and has a first surface 31F and a second surface 31R which is the surface opposite to the first surface 31F. The needle-shaped portion 20 extends from the first surface 31F.

[0028] The shape of the needle-shaped portion 20 is not limited to anything that can penetrate the tissue in which the graft 50 is to be placed. From the viewpoint of increasing the ease with which the needle-shaped portion 20 penetrates the living body, it is preferable that the needle-shaped portion 20 has a shape that extends along one direction and that the tip of the needle-shaped portion 20 is pointed. The direction in which the needle-shaped portion 20 extends may be perpendicular to the first surface 31F of the substrate portion 30, or it may be inclined with respect to the first surface 31F.

[0029] For example, the needle-shaped portion 20 may have a shape such as a cone or pyramidal shape, where the cross-sectional area decreases from the base to the tip. Alternatively, the needle-shaped portion 20 may have a shape such as a cylinder cut diagonally in the direction of its extension, or a cone extending from the top surface of a cylinder, where it extends from the base with a constant cross-sectional area and then the cross-sectional area decreases towards the tip. Or, the needle-shaped portion 20 may have a blade-like structure at its tip.

[0030] However, the tip of the needle-shaped portion 20 may have a curved shape, or the needle-shaped portion 20 may have a shape that is not pointed at the tip, such as a cylindrical or prismatic shape, as long as the needle-shaped portion 20 can pierce the tissue in which the graft 50 is to be placed. The length of the needle-shaped portion 20 is, for example, 200 μm or more and 2 mm or less, and the maximum outer diameter of the needle-shaped portion 20 is, for example, 100 μm or more and 1 mm or less.

[0031] The needle-shaped portion 20 and the substrate portion 30 may be integrally formed from the same material, or they may be formed separately and joined together. Furthermore, the substrate portion 30 may be a laminate comprising a plate-shaped portion integrally formed with the needle-shaped portion 20 and continuous from the base end of the needle-shaped portion 20, and other plate-shaped portions joined to the plate-shaped portion.

[0032] In transplanter 10A, an example of transplanter 10 shown in Figure 1, the transplanted plant 50 is embedded inside the needle-shaped portion 20. Alternatively, as in transplanter 10B, another example shown in Figure 2, the needle-shaped portion 20 may have a receiving hole 25, which is a recessed hole extending inward from the base end of the needle-shaped portion 20, and the transplanted plant 50 may be contained within the receiving hole 25.

[0033] The accommodating hole 25 opens at the base end of the needle-shaped portion 20. The opening of the accommodating hole 25 is closed by the base portion 30. The shape and size of the accommodating hole 25 are not particularly limited as long as they can accommodate the implant 50. In the example shown in Figure 2, the accommodating hole 25 extends with a constant inner diameter from the opening located at the base end of the needle-shaped portion 20, and then tapers towards the bottom of the accommodating hole 25. The cross-sectional shape of the accommodating hole 25 along the direction perpendicular to the direction in which the needle-shaped portion 20 extends is circular, and the bottom of the accommodating hole 25 is curved. However, the sides of the accommodating hole 25 may be inclined surfaces, and the inner diameter of the accommodating hole 25 may gradually change from the opening. The bottom surface of the accommodating hole 25 may also be flat.

[0034] In addition to the graft 50, the containment hole 25 may also contain an auxiliary fluid 51, which is a fluid that helps maintain the activity of cells within the containment hole 25 and assists in the engraftment of cells after they are placed in the body. Within the containment hole 25, the graft 50 is surrounded by the auxiliary fluid 51. The auxiliary fluid 51 does not have to surround the entire circumference of the graft 50; for example, the graft 50 may be placed at the bottom of the containment hole 25, and the auxiliary fluid 51 may cover the graft 50 in the area from above the graft 50 to the opening.

[0035] Figure 3 shows another example of the transplanter 10, the transplanter 10C. As shown in Figure 3, the transplanter 10 may have multiple needle-like sections 20. Each needle-like section 20 holds a plant to be transplanted 50. The base sections 30 are connected at adjacent needle-like sections 20, forming an aggregate of multiple needle-like sections 20. That is, one common base section 30 is provided for multiple needle-like sections 20.

[0036] If the transplanter 10 is equipped with multiple needle-shaped parts 20, the multiple needle-shaped parts 20 may be arranged regularly or irregularly. For example, the multiple needle-shaped parts 20 may be arranged in a single row, or they may be arranged in multiple rows such that a needle-shaped part 20 is located at each grid point of a square or triangular grid. In addition, in the arrangement of the multiple needle-shaped parts 20, the spacing between adjacent needle-shaped parts 20 may or may not be constant. Because the transplanter 10 is equipped with multiple needle-shaped parts 20, multiple transplants 50 can be placed together in the living body.

[0037] [Composition of transplanted material] The graft 50 includes a group of cells. The group of cells includes multiple cells. The group of cells may be an aggregate of multiple cells, or an aggregate of multiple cells connected by intercellular junctions. Alternatively, the group of cells may consist of multiple dispersed cells. Furthermore, the cells that make up the group may be undifferentiated cells or fully differentiated cells, and the group of cells may include both undifferentiated and differentiated cells. Examples of the group of cells include spheroids, cell aggregates, primordia, tissues, organs, organoids, miniature organs, etc.

[0038] Cell groups, when placed within a living organism, have the ability to influence tissue formation in that organism. One example of such cell groups is a cell aggregate containing stem cell-like cells. Cell groups contribute to hair growth or development when placed, for example, intradermally or subcutaneously. Specifically, cell groups have the ability to function as hair follicle organs, the ability to differentiate into hair follicle organs, the ability to induce or promote the formation of hair follicle organs, or the ability to induce or promote hair formation in hair follicle organs. Furthermore, cell groups may include cells that contribute to the control of hair color, such as pigment cells or stem cells that differentiate into pigment cells. Cell groups may also include vascular cells.

[0039] A concrete example of a cell group is an organ primordium. Organ primordium includes mesenchymal cells and epithelial cells. Examples of organ primordium include the hair follicle primordium that differentiates into hair follicle organs, the liver primordium, the kidney primordium, the pancreas primordium, and cell groups such as the nervous system primordium and the vascular system primordium.

[0040] For example, hair follicle primordia are formed by culturing mesenchymal cells derived from mesenchymal tissue such as the dermal papilla and epithelial cells derived from epithelial tissue located in the bulge region or hair bulb base under predetermined conditions. However, the method for producing hair follicle primordia is not limited to the above example. Furthermore, the origin of the mesenchymal and epithelial cells used in the production of hair follicle primordia is not limited; these cells may be derived from the hair follicle organ, from an organ other than the hair follicle organ, or from pluripotent stem cells. Furthermore, the transplant 50 may include, in addition to the cell population, components that assist in the transplantation and engraftment of the cell population, and a gel-like substance that protects the cell population.

[0041] The auxiliary solution 51 should contain components that do not easily inhibit cell survival, and preferably components that have little effect on the body when injected into the body. The auxiliary solution 51 helps maintain the activity of the graft 50 by surrounding the graft 50 and suppressing contact and friction between the graft 50 and the inner surface of the containment hole 25. Alternatively, the graft 50 may contain components similar to those of the body's fluids to surround the graft 50 or provide nutrients to the graft 50, thereby helping to maintain the activity of the graft 50 and facilitate engraftment.

[0042] The auxiliary solution 51 may be, for example, physiological saline, a skin-protecting substance such as petrolatum or lotion, or a mixture thereof. The auxiliary solution 51 may also contain nutrients and components necessary for cell survival, such as oxygen. Furthermore, the auxiliary solution 51 may be a culture medium for cell culture. The auxiliary solution 51 may be a low-viscosity fluid or a high-viscosity fluid. The auxiliary solution 51 may be a sol or a gel.

[0043] [Materials for transplanting equipment] The materials used for each part of the transplanting device 10 will be described in detail. The needle-shaped portion 20 contains a water-soluble material and an oil-soluble material, and loses its shape in the body due to the dissolution, melting, or decomposition of these materials. In other words, the needle-shaped portion 20 dissolves in the body. In the needle-shaped portion 20, the water-soluble material and the oil-soluble material are uniformly mixed. In other words, the material of the needle-shaped portion 20 is a mixture of a water-soluble material and an oil-soluble material.

[0044] Water-soluble materials are preferably biocompatible. Specific examples of water-soluble materials are water-soluble polymers. Examples of water-soluble polymers used as the main component of water-soluble materials include hydroxypropyl cellulose, pullulan, pectin, chondroitin sulfate sodium, dextran, collagen, atelocollagen, hyaluronic acid, and sodium hyaluronate. The needle-shaped portion 20 may contain multiple types of water-soluble materials.

[0045] Oily materials are non-water soluble. Specific examples of oily materials include vegetable oils, animal oils, mineral oils, and oils synthesized from these raw materials. It is preferable that oily materials are materials that are unlikely to harm living organisms; that is, materials that are unlikely to cause severe inflammation or other damage when in contact with living organisms, and that do not have serious toxicity to organs or other tissues.

[0046] Examples of oily materials include olive oil, rapeseed oil, palm oil, squalane, petrolatum, paraffin, and hard fat. The needle-shaped portion 20 may contain multiple types of oily materials.

[0047] The oily material is preferably in a solid or semi-solid state, such as a cream, at room temperature. The melting point of the oily material is preferably, for example, 15°C to 70°C, and more preferably 30°C to 40°C. If the melting point of the oily material is within the above range, the oily material is less likely to become liquid at room temperature, making it easier for the needle-shaped portion 20 to maintain the desired shape before use. On the other hand, the oily material is more likely to become liquid due to the temperature inside the body, thus preventing the needle-shaped portion 20 from remaining in the body for a long period of time.

[0048] The proportion of the oily material to the total mass of the needle-shaped portion 20 is preferably 1% by mass or more and 60% by mass or less. Furthermore, the proportion of the water-soluble material to the total mass of the needle-shaped portion 20 is preferably 40% by mass or more and 99% by mass or less. If the proportion of the oily material is 60% by mass or less and the proportion of the water-soluble material is 40% by mass or more, the strength of the needle-shaped portion 20 can be obtained appropriately. In addition, mixing of the water-soluble material and the oily material becomes easier, and it becomes easier to form the needle-shaped portion 20 into a desired shape. Furthermore, if the proportion of the oily material is 1% by mass or more and the proportion of the water-soluble material is 99% by mass or less, the rapid dissolution of the needle-shaped portion 20 upon contact with a living organism can be suppressed.

[0049] The needle-shaped portion 20 may further contain additives having components that contribute to the formation of the needle-shaped portion 20, or to the maintenance of cell activity and engraftment. For example, the needle-shaped portion 20 may contain surfactants or emulsifiers as additives to facilitate the formation of the needle-shaped portion 20. Specifically, when the oily material is a material with a high melting point, such as petrolatum, the addition of a surfactant makes it easier to mix the water-soluble material and the oily material. As a surfactant, for example, sucrose fatty acid ester is preferably used. The ratio of the surfactant to the total mass of the needle-shaped portion 20 is preferably 0.1% by mass or more and 5% by mass or less.

[0050] For example, when palm oil is used as the oily material, the palm oil content in the needle-shaped portion 20 is preferably 1% by mass or more and 30% by mass or less. Also, when petrolatum is used as the oily material, the needle-shaped portion 20 contains petrolatum and sucrose fatty acid ester, and it is preferable that the petrolatum content in the needle-shaped portion 20 is 5% by mass or more and 40% by mass or less, and the sucrose fatty acid ester content is 0.5% by mass or more and 2% by mass or less. With such a configuration, it becomes easier to form the needle-shaped portion 20 into the desired shape.

[0051] In addition to the materials mentioned above, other materials that the needle-shaped portion 20 may contain include, for example, hydroxypropyl methylcellulose, dextrin, starch, cellulose, chitosan, pectinic acid, galactan, chondroitin sulfate, carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, polyvinyl alcohol, polyacrylic acid polymers, polyacrylamide, polyethylene oxide, alginate, chondroitin sulfate, poly2-ethyl-2-2-oxazoline, poly2-methyl-2-oxazoline, carboxyvinyl polymer, galactan, leozane, xanthan gum, casein, polyvinylpyrrolidone, glucomannan, polymalic acid, and curdlan. Furthermore, it is preferable that the needle-shaped portion 20 is transparent, as this makes it easier to check the condition of the graft material 50 inside the needle-shaped portion 20 from the outside.

[0052] The material of the substrate portion 30 may be the same as that of the needle-shaped portion 20, or it may be different from that of the needle-shaped portion 20. Furthermore, the substrate portion 30 may or may not be soluble in water. For example, the substrate portion 30 may contain only a water-soluble material, or it may contain both a water-soluble material and an oil-soluble material. Alternatively, the substrate portion 30 may be formed from a material that is different from both the water-soluble material and the oil-soluble material.

[0053] As the material for the substrate portion 30, for example, the various materials described above, as exemplified for the material of the needle-shaped portion 20, can be used. Alternatively, a resin sheet made of biocompatible resin may be used as the substrate portion 30.

[0054] In this embodiment, the needle-shaped portion 20 is soluble in water. The solubility of the object, which consists of the needle-shaped portion 20 and the substrate portion 30, in water means that when the object is immersed in stirred 25°C water for 5 minutes, 0.05% or more of the mass of the object in the water dissolves.

[0055] [Method of arranging transplanted plants] Referring to Figures 4 to 6, the method of placing the graft 50 into the living body using the transplantation device 10, that is, the method of transplanting the graft 50, will be explained. The method of placing the graft 50 is, in other words, the method of using the transplantation device 10.

[0056] As shown in Figure 4, first, the needle-shaped portion 20 of the transplanter 10 is pressed against the target tissue Sk where the graft 50 will be placed, thereby piercing the target tissue Sk. The target tissue Sk is, for example, skin. At this time, an applicator may be used to assist in the entry of the needle-shaped portion 20 into the target tissue Sk by adjusting the force applied to the needle-shaped portion 20 and the orientation of the needle-shaped portion 20. Note that when the needle-shaped portion 20 is embedded in the target tissue Sk, the substrate portion 30 does not penetrate into the interior of the target tissue Sk, but is positioned on the surface of the target tissue Sk.

[0057] As shown in Figure 5, when the needle-shaped portion 20 enters the target tissue Sk, it melts due to contact between the needle-shaped portion 20 and the water in the tissue, and because the needle-shaped portion 20 is warmed to a temperature close to the body temperature.

[0058] If the substrate portion 30 is water-soluble, it will dissolve upon contact with the moisture on the surface of the target tissue Sk. If the substrate portion 30 is not water-soluble, it will be peeled off from the surface of the target tissue Sk. The peeling off of the substrate portion 30 may be performed before the needle-shaped portion 20 is completely dissolved, or after the needle-shaped portion 20 is completely dissolved. If the substrate portion 30 is in a form that dissolves, peeling off the substrate portion 30 becomes unnecessary, thus reducing the effort required to use the transplanter 10.

[0059] As shown in Figure 6, as the needle-shaped portion 20 melts and deforms, it collapses and disappears, exposing the graft 50 that was held inside the needle-shaped portion 20, which is then retained within the target tissue Sk. If an auxiliary fluid 51 was also contained with the graft 50, the auxiliary fluid 51 also penetrates into the surrounding tissue. The components of the needle-shaped portion 20 are diffused and absorbed into the body. This completes the placement of the graft 50 into the body.

[0060] As described above, according to the method of graft placement of the graft 50 in this embodiment, the graft 50 is inserted into the body while being held by the needle-shaped portion 20, and is placed in the body by the disappearance of the needle-shaped portion 20. Therefore, since the instrument such as tweezers is not withdrawn from the body when placing the graft 50 into the body, the graft 50 is less likely to come out of the body together with the instrument. Thus, the efficiency of graft placement is increased, and it becomes easier to control the depth of placement of the graft 50 in the tissue of the body to a desired depth.

[0061] Furthermore, since the graft 50 is inserted into the body while being held inside the needle-shaped portion 20, it is possible to protect the graft 50 from impact during insertion. In addition, compared to the case where only the graft 50 is inserted into the body, it is easier to identify the implantation site of the graft 50 from the outside.

[0062] If the needle-shaped portion 20 is formed solely from a water-soluble material, the dissolution of the needle-shaped portion 20 proceeds rapidly from the moment it comes into contact with the surface of the living body. This dissolution of the needle-shaped portion 20 proceeds from the tip of the needle-shaped portion 20 that first comes into contact with the living body. Therefore, it is possible that the shape of the tip of the needle-shaped portion 20 may collapse before it reaches the desired depth, making it difficult for the needle-shaped portion 20 to penetrate into the tissue. Furthermore, if the base of the needle-shaped portion 20 dissolves, the force pressing the implantation device 10 becomes less easily transmitted to the needle-shaped portion 20, which can also make it difficult for the needle-shaped portion 20 to penetrate into the tissue. As a result, the needle-shaped portion 20 may not penetrate to the desired depth, hindering the placement of the implant 50 into the living body.

[0063] In contrast, in this embodiment, since the needle-shaped portion 20 contains an oily material in addition to a water-soluble material, the deformation of the needle-shaped portion 20 progresses more slowly compared to the case where the needle-shaped portion 20 consists only of a water-soluble material. For example, when the proportion of oily material in the needle-shaped portion 20 is about 50% by mass, the time required for the shape of the needle-shaped portion 20 to be completely lost is about 1.2 to 10 times longer than when the needle-shaped portion 20 consists only of a water-soluble material. Therefore, in the initial stages after the needle-shaped portion 20 enters the living body, the shape of the needle-shaped portion 20 is more easily maintained, making it easier for the needle-shaped portion 20 to penetrate to the desired depth. Consequently, the implant 50 is more easily positioned at the desired depth. The rate at which the needle-shaped portion 20 dissolves can be adjusted by the types of water-soluble and oily materials and the proportion of the oily material.

[0064] Furthermore, if the liquefaction of the substrate portion 30 is completed after the needle-shaped portion 20 has dissolved, or if the substrate portion 30 is peeled off after the needle-shaped portion 20 has dissolved, the surface of the area in the target tissue Sk where the needle-shaped portion 20 is embedded is covered by the substrate portion 30 while the needle-shaped portion 20 is dissolving. Therefore, even if subjected to external impact, the needle-shaped portion 20 and the graft 50 are prevented from coming out of the target tissue Sk.

[0065] On the other hand, if the liquefaction of the substrate portion 30 is completed before the needle-shaped portion 20 dissolves, or if the substrate portion 30 is peeled off before the needle-shaped portion 20 dissolves, the location where the needle-shaped portion 20 is embedded becomes easier to see. Therefore, additional treatments such as protecting the location where the needle-shaped portion 20 is embedded or applying a chemical agent to this location can be easily performed.

[0066] If the substrate portion 30 is soluble in water, the rate at which the substrate portion 30 dissolves can be adjusted by the material of the substrate portion 30. For example, if the substrate portion 30 contains the same type of water-soluble material and oily material as the needle-shaped portion 20, and the proportion of oily material in the substrate portion 30 and the proportion of oily material in the needle-shaped portion 20 are different, the dissolution rates of the substrate portion 30 and the dissolution rates of the needle-shaped portion 20 can be made different.

[0067] Furthermore, if the transplanter 10 has multiple needle-shaped parts 20, the proportion of oily material in each needle-shaped part 20 does not have to be constant. That is, the multiple needle-shaped parts 20 may include a first needle-shaped part 20 and a second needle-shaped part 20, and the proportion of oily material in the first needle-shaped part 20 and the proportion of oily material in the second needle-shaped part 20 may be different from each other. With such a configuration, the time required for the shape to disappear can be made different for the first needle-shaped part 20 and the second needle-shaped part 20. Moreover, the oily material contained in the first needle-shaped part 20 and the oily material contained in the second needle-shaped part 20 may be different from each other. In addition, the transplanter 10 may also have needle-shaped parts that do not contain oily material.

[0068] [Manufacturing method for transplanters] The manufacturing method of the transplanter 10 will be described with reference to Figures 7 and 8. As shown in Figure 7, the needle-shaped portion 20 is formed by filling a recessed plate 80 having a recess 81 corresponding to the desired shape of the needle-shaped portion 20 with a needle-shaped portion forming liquid containing the material for the needle-shaped portion 20, and then allowing the filler to solidify. After the filler has solidified, the graft 50 is placed inside the needle-shaped portion 20 from a tray such as a culture container.

[0069] The needle-forming solution is produced, for example, by dissolving a water-soluble material in a solvent such as water, and then mixing this solution with an oily material. Heating of the materials may be performed during the production of the needle-forming solution. Solidification of the filler may be performed by drying, or by using ultraviolet light or heat.

[0070] When forming the receiving hole 25, the filling and solidification of the needle-shaped portion forming liquid are controlled so that air bubbles accumulate in the center of the filling material that will become the needle-shaped portion 20, thereby creating a void inside the needle-shaped portion 20. This allows the receiving hole 25, which is the void, to be formed. Alternatively, a pin-shaped structure with a shape corresponding to the receiving hole 25 may be inserted into the center of the filling material, and after the filling material has solidified, the structure may be removed. This allows a void, which is the receiving hole 25, to be formed in the area where the pin-shaped structure was located.

[0071] As shown in Figure 8, the base portion 30 is placed on the surface located at the base end of the needle-shaped portion 20, and the needle-shaped portion 20 and the base portion 30 are joined together. The base portion 30 is formed, for example, by sandwiching the material of the base portion 30 between two plate-shaped members and allowing the material to solidify.

[0072] The substrate portion 30 may be joined by adhesive, or by heat welding or welding using ultrasonic vibration. Furthermore, the needle-shaped portion 20 may be softened by heat or other means when joining the substrate portion 30. The transplanter 10 is obtained by releasing the needle-shaped portion 20 from the intaglio plate 80. The release may be performed before joining the substrate portion 30.

[0073] Furthermore, the manufacturing method of the transplanter 10 may differ from the above-described method, as long as it is possible to form a transplanter 10 that holds the transplanted plant 50 inside the needle-shaped portion 20. For example, a recess corresponding to the substrate portion 30 may be provided in the intaglio plate 80, and the substrate portion 30 may be formed by filling the recess with the material for the substrate portion 30 and solidifying it.

[0074] As described above, according to the first embodiment, the following effects can be obtained. (1) The graft 50 is inserted into the body while being held by the needle-shaped portion 20, and is positioned in the body as the needle-shaped portion 20 dissolves. Therefore, the graft 50 is less likely to come out of the body, the efficiency of graft placement is increased, and the depth of placement of the graft 50 in the body tissue can be easily controlled to a desired depth.

[0075] (2) Because the needle-shaped portion 20 contains both a water-soluble material and an oil-soluble material, the rapid dissolution of the needle-shaped portion 20 is suppressed. Therefore, in the initial stages after the needle-shaped portion 20 has entered the body, the shape of the needle-shaped portion 20 is more easily maintained, making it easier for the needle-shaped portion 20 to penetrate to the desired depth. Consequently, the implant 50 is more easily positioned at the desired depth.

[0076] (3) The water-soluble material includes a water-soluble polymer, and the oily material includes at least one of vegetable oils, animal oils, mineral oils, and oils synthesized using these as raw materials. With this configuration, needle-shaped portions 20 that dissolve slowly in living organisms can be suitably realized.

[0077] (4) When the proportion of oily material in the needle-shaped portion 20 is 60% by mass or less, the strength of the needle-shaped portion 20 can be obtained to an appropriate degree. In addition, it becomes easier to mix the water-soluble material and the oily material to form the needle-shaped portion 20 into a desired shape.

[0078] (5) Since the water-soluble material and the oil-soluble material are uniformly mixed in the needle-shaped portion 20, the rapid dissolution of the needle-shaped portion 20 can be suppressed throughout the entire needle-shaped portion 20. (6) If the material of the needle-shaped portion 20 contains a surfactant, it becomes easier to mix the water-soluble material and the oil-soluble material, even if the melting point of the oil-soluble material is high.

[0079] (7) Because the substrate portion 30 contains both a water-soluble material and an oil-based material, the substrate portion 30 dissolves when it comes into contact with the surface of a living organism. This eliminates the need to peel off the substrate portion 30, thus reducing the effort required to use the implantation device 10. Furthermore, the inclusion of the oil-based material allows for adjustment of the rate at which the substrate portion 30 dissolves.

[0080] (8) If the proportion of oily material in the substrate portion 30 is different from the proportion of oily material in the needle-shaped portion 20, the rate at which the substrate portion 30 melts can be made different from the rate at which the needle-shaped portion 20 melts.

[0081] (9) If the transplanter 10 is equipped with a plurality of needle-shaped parts 20, and the proportion of oily material in the first needle-shaped part 20 is different from the proportion of oily material in the second needle-shaped part 20, the rate at which the first needle-shaped part 20 dissolves can be made different from the rate at which the second needle-shaped part 20 dissolves.

[0082] (Second Embodiment) A second embodiment of the transplanter will be described with reference to Figures 9 to 12. In the second embodiment, the configuration of the needle-shaped part differs from that of the first embodiment. The configuration of the transplant and the target of the placement of the transplant in the second embodiment are the same as in the first embodiment. In the following, the differences between the second embodiment and the first embodiment will be described in detail, and components similar to those in the first embodiment will be denoted by the same reference numerals and their descriptions will be omitted.

[0083] In the needle-shaped portion 20 of the implanter 11 of the second embodiment, the concentration of the oily material is uneven. Specifically, the needle-shaped portion 20 has a water-soluble portion 21 and an oily portion 22. The water-soluble portion 21 contains a water-soluble material, and the oily portion 22 contains an oily material. The materials exemplified in the first embodiment are used as the water-soluble material and the oily material. The configuration of the substrate portion 30 is the same as in the first embodiment. Furthermore, the placement of the implant 50 into the living body using the implanter 11 of the second embodiment is performed using the same procedure as in the first embodiment.

[0084] The first example of the transplanter 11A shown in Figure 9 has an oily portion 22 on the surface of the needle-shaped portion 20. In other words, the oily portion 22 covers the surface of the water-soluble portion 21. The water-soluble portion 21 has a shape that allows it to pierce living organisms, similar to the needle-shaped portion 20 of the first embodiment. The transplanted plant 50 is held in the water-soluble portion 21. In addition, similar to the transplanter 10B of the first embodiment, the transplanted plant 50 may be contained in a containment hole formed in the water-soluble portion 21.

[0085] In the first example of the transplanter 11A, when the needle-shaped portion 20 is inserted into the living body, the water-soluble portion 21 is less likely to come into contact with moisture until the oily portion 22 dissolves. Therefore, compared to the case where the entire needle-shaped portion 20 is the water-soluble portion 21, the start of dissolution of the water-soluble portion 21 can be delayed. Consequently, in the initial stages after the needle-shaped portion 20 enters the living body, it is easier to maintain a shape that is easy to insert into the living body, making it easier for the needle-shaped portion 20 to penetrate to the desired depth. Therefore, it is easier for the transplanted material 50 to be positioned at the desired depth.

[0086] Furthermore, the oily portion 22 may cover only a part of the surface of the water-soluble portion 21. For example, even if the oily portion 22 covers only the tip of the water-soluble portion 21, the shape of the tip of the needle-shaped portion 20 is more easily maintained, making it easier for the needle-shaped portion 20 to penetrate to the desired depth.

[0087] The first example of the transplanter 11A can be formed, for example, by applying the material of the oily portion 22 to the inner surface of a recess corresponding to the shape of the needle-shaped portion 20 in the intaglio plate to form the oily portion 22, and then filling it with the material of the water-soluble portion 21 to form the water-soluble portion 21. Alternatively, the water-soluble portion 21 may be formed using the intaglio plate, and then the oily portion 22 may be formed by applying the material of the oily portion 22 to the surface of the water-soluble portion 21.

[0088] The second example of the transplanter 11B shown in Figure 10 has an oily portion 22 at the base of the needle-shaped portion 20. The portion other than the oily portion 22 is a water-soluble portion 21, and the tip of the needle-shaped portion 20 is included in the water-soluble portion 21. The oily portion 22 may be in contact with the substrate portion 30, or it may be surrounded by the water-soluble portion 21 at the base of the needle-shaped portion 20. In addition, although Figure 10 shows a configuration in which the oily portion 22 is surrounded by the water-soluble portion 21 and the substrate portion 30, if sufficient strength of the oily portion 22 can be obtained, the entire base of the needle-shaped portion 20 may be the oily portion 22, and the oily portion 22 may be exposed on the surface of the needle-shaped portion 20.

[0089] The graft material 50 may be held in the water-soluble portion 21 or in the oil-soluble portion 22. Also, similar to the transplanter 10B of the first embodiment, the graft material 50 may be contained in the containment holes formed in the water-soluble portion 21 and the oil-soluble portion 22, or in the containment holes formed in the oil-soluble portion 22.

[0090] In the second example of the transplanter 11B, compared to the case where the entire needle-shaped portion 20 is a water-soluble portion 21, the time required for the base of the needle-shaped portion 20 to dissolve when the needle-shaped portion 20 is inserted into the living body is increased. Therefore, the rapid dissolution of the base of the needle-shaped portion 20, which would otherwise hinder the transmission of force to the transplanter 11 to the needle-shaped portion 20, is suppressed. As a result, the needle-shaped portion 20 becomes easier to insert to the desired depth.

[0091] Furthermore, if the base of the needle-shaped portion 20 dissolves rapidly, the graft 50 may be subjected to pressure from the liquid of the dissolved base. The inclusion of the oily portion 22 in the base of the needle-shaped portion 20 helps to suppress such sudden pressure on the graft 50. In addition, because the shape of the base of the needle-shaped portion 20 is easily maintained, the position where the needle-shaped portion 20 is inserted becomes easier to see due to liquefaction or peeling of the substrate portion 30.

[0092] The second example of the transplanter 11B can be formed, for example, by filling the recesses corresponding to the shape of the needle-shaped portion 20 in the intaglio plate with the material of the water-soluble portion 21 to form the water-soluble portion 21, and then filling them with the material of the oil-soluble portion 22 to form the oil-soluble portion 22.

[0093] Figure 11 shows a third example of the transplanter 11C. If sufficient strength can be obtained from the oily portion 22, the transplanter 11C may be equipped with the oily portion 22 at the tip of the needle-shaped portion 20, as shown in Figure 11. The portion other than the oily portion 22 is the water-soluble portion 21, and the base of the needle-shaped portion 20 is included in the water-soluble portion 21.

[0094] The graft material 50 may be held in the water-soluble portion 21 or in the oil-soluble portion 22. Also, similar to the grafting device 10B of the first embodiment, the graft material 50 may be contained in a containment hole formed in the water-soluble portion 21, or in a containment hole formed in both the water-soluble portion 21 and the oil-soluble portion 22.

[0095] In the third example of the transplanter 11C, compared to the case where the entire needle-shaped portion 20 is a water-soluble portion 21, the shape of the tip of the needle-shaped portion 20 is more easily maintained when the needle-shaped portion 20 is inserted into the living body. Therefore, the needle-shaped portion 20 is more easily inserted to the desired depth, and the transplanted material 50 is more easily positioned at the desired depth.

[0096] The third example of the transplanter 11C can be formed, for example, by filling the recess corresponding to the shape of the needle-shaped portion 20 in the intaglio plate with the material of the oily portion 22 to form the oily portion 22, and then filling it with the material of the water-soluble portion 21 to form the water-soluble portion 21.

[0097] The fourth example of the transplanter 11D shown in Figure 12 is equipped with an oily portion 22 on the surface of the containment hole 25. In detail, the water-soluble portion 21 has a shape that can pierce living tissue, similar to the needle-shaped portion 20 of the first embodiment, and has an internal hole 23 that is recessed inward from its base end. The oily portion 22 covers the inner surface of the internal hole 23. The hole formed by the inner surface of the oily portion 22 is the containment hole 25. The transplanted plant 50 is contained within the containment hole 25. Similar to the first embodiment, an auxiliary liquid 51 may be contained in the containment hole 25 together with the transplanted plant 50.

[0098] In the fourth example of the transplanter 11D, the water-containing graft 50 is prevented from coming into contact with the inner surface of the internal pores 23 in the water-soluble portion 21. Therefore, it is possible to prevent the needle-shaped portion 20 from dissolving from the inside before it is inserted into the living body. Furthermore, even if the water-soluble portion 21 dissolves rapidly after the needle-shaped portion 20 is inserted into the living body, the presence of the oily portion 22 around the graft 50 prevents the graft 50 from being subjected to pressure from the dissolved water-soluble portion 21.

[0099] Furthermore, because the oily portion 22 covers the inner surface of the internal pore 23, contact between the auxiliary solution 51 and the inner surface of the internal pore 23 is suppressed. Therefore, even if the auxiliary solution 51 contains water, the dissolution of the needle-shaped portion 20 from the inside is suppressed. Consequently, the degree of freedom regarding the components of the auxiliary solution 51 that can be contained is increased, and an auxiliary solution 51 suitable for maintaining the activity of cells contained in the graft 50 and assisting engraftment can be stored inside the needle-shaped portion 20 together with the graft 50.

[0100] The fourth example of the transplanter 11D can be formed, for example, by filling the recesses corresponding to the shape of the needle-shaped portion 20 in the intaglio plate with the material of the water-soluble portion 21 to form the water-soluble portion 21 having internal holes 23, and then applying the material of the oily portion 22 to the inner surface of the internal holes 23 to form the oily portion 22.

[0101] The shape of the internal hole 23 and the shape of the receiving hole 25 may be similar or different. Also, the thickness of the oily portion 22 may be constant or vary in parts.

[0102] [Differentiation] In the transplanter 11 of the second embodiment, the position of the oily portion 22 may differ from that of the first to fourth examples described above, as long as the needle-shaped portion 20 has a water-soluble portion 21 and an oily portion 22. For example, the oily portion 22 may be located in the center of the needle-shaped portion 20, or the needle-shaped portion 20 may have multiple oily portions 22 that are separated from each other within the needle-shaped portion 20.

[0103] Furthermore, as shown in the first to fourth examples, an interface may exist between the water-soluble portion 21 and the oily portion 22, or there may be no interface between the water-soluble portion 21 and the oily portion 22, and the concentration of the oily material may gradually change between the water-soluble portion 21 and the oily portion 22.

[0104] The water-soluble portion 21 does not necessarily contain oily materials, or it may contain oily materials mixed with water-soluble materials. Similarly, the oily portion 22 does not necessarily contain water-soluble materials, or it may contain water-soluble materials mixed with oily materials. However, the mass ratio of oily materials in the oily portion 22 is greater than the mass ratio of oily materials in the water-soluble portion 21. That is, the concentration of oily materials is higher in the oily portion 22 than in the water-soluble portion 21. In addition, each of the water-soluble portion 21 and the oily portion 22 may contain various materials other than water-soluble materials and oily materials, such as the additives exemplified in the first embodiment. Similar to the first embodiment, the proportion of oily materials to the total needle-shaped portion 20 is preferably 1% by mass or more and 60% by mass or less, and the proportion of water-soluble materials to the total needle-shaped portion 20 is preferably 40% by mass or more and 99% by mass or less.

[0105] Furthermore, similar to the second embodiment, the transplanter 11 may also be provided with a plurality of needle-shaped parts 20. In this case, the arrangement of the oily parts 22 in the plurality of needle-shaped parts 20 may or may not be the same. For example, the plurality of needle-shaped parts 20 may include a first needle-shaped part 20 and a second needle-shaped part 20, and the position of the oily part 22 in the first needle-shaped part 20 may be different from the position of the oily part 22 in the second needle-shaped part 20. Moreover, the ratio and type of oily material contained in the first needle-shaped part 20 and the oily material contained in the second needle-shaped part 20 may be different from each other. In addition, the transplanter 11 may be provided with the needle-shaped parts 20 of the first embodiment and the needle-shaped parts 20 of the second embodiment, or it may be provided with needle-shaped parts that do not contain oily material.

[0106] As described above, according to the second embodiment, in addition to the effects of (1) to (4) and (7) to (9) of the first embodiment, the following effects can be obtained. (11) Because the concentration of the oily material in the needle-shaped portion 20 is uneven within the needle-shaped portion 20, the rate at which the needle-shaped portion 20 dissolves can be partially slowed down.

[0107] (12) By having a water-soluble portion 21 and an oily portion 22 in the needle-shaped portion 20, a needle-shaped portion 20 in which the concentration of the oily material differs in parts can be suitably realized. (13) If the oily portion 22 is located on the surface of the needle-shaped portion 20, the start of dissolution of the water-soluble portion 21 can be delayed, so that the needle-shaped portion 20 is more likely to maintain a shape that is easily penetrated into the body in the initial stages after entering the body. Therefore, the needle-shaped portion 20 is more likely to penetrate to the desired depth, so that the graft 50 is more likely to be placed at the desired depth.

[0108] (14) If the oily portion 22 is located at the base of the needle-shaped portion 20, the base of the needle-shaped portion 20 will rapidly dissolve, making it difficult for the force pressing the transplanter 11 to be transmitted to the needle-shaped portion 20, and the pressure on the transplanted material 50 from the dissolved base liquid will be suppressed. In addition, since the shape of the base of the needle-shaped portion 20 is more easily maintained, the position in which the needle-shaped portion 20 is inserted will be easier to see due to the liquefaction and peeling of the substrate portion 30.

[0109] (15) If the oily portion 22 is located at the tip of the needle-shaped portion 20, the shape of the tip of the needle-shaped portion 20 is more likely to be maintained in the initial stages of the needle-shaped portion 20 entering the living body. Therefore, the needle-shaped portion 20 is more likely to penetrate to the desired depth, and the graft 50 is more likely to be positioned at the desired depth.

[0110] (16) If the oily portion 22 is located on the surface of the containment hole 25, contact between the water-containing graft material 50 and auxiliary fluid 51 and the water-soluble portion 21 is suppressed. Therefore, the dissolution of the needle-shaped portion 20 from the inside before it is inserted into the living body is suppressed.

[0111] (Examples) Regarding the transplanter described above, a test example of the needle-shaped portion was prepared, and tests were conducted to evaluate the moldability and melting speed of the needle-shaped portion. The needle-shaped portion of the test example corresponds to the needle-shaped portion of the first embodiment.

[0112] (Test Example 1) A needle-forming solution was prepared by adding palm oil to an aqueous pullulan solution in a heat-conductive container on a magnetic stirrer heated to 40°C, and mixing with a stirrer bar for 10 minutes. Pullulan is a water-soluble material, and palm oil is an oil-soluble material. The ratio of palm oil to the total mass of pullulan and palm oil in the needle-forming solution was 50% by mass. The palm oil was heated in a heating device such as a clean oven and dissolved into a liquid before use.

[0113] A recessed plate with a square pyramidal recess was prepared, and the recess was filled with a needle-forming solution. The opening surface of the recess had a square shape with sides of 800 μm, and the depth of the recess was 1.8 mm. Furthermore, the needle-forming solution was spread on top of the recess to form a portion corresponding to the substrate. The recessed plate filled with the needle-forming solution was then dried for 72 hours with ventilation in an environment of 25°C and 30% humidity. This formed the needle-like filler material in the recess and the substrate portion.

[0114] Next, the needle-shaped portion of Test Example 1 was obtained by gripping the substrate portion and releasing the needle-shaped portion from the intaglio plate. (Test Example 2) The needle-like structures of Test Example 2 were obtained using the same materials and process as in Test Example 1, except that the proportion of palm oil in the needle-like structure forming solution was changed. The proportion of palm oil in the needle-like structure forming solution in Test Example 2 was 10% by mass.

[0115] (Test Example 3) The needle-like structures of Test Example 3 were obtained using the same materials and process as in Test Example 1, except that the proportion of palm oil in the needle-like structure forming solution was changed. The proportion of palm oil in the needle-like structure forming solution in Test Example 3 was 1% by mass.

[0116] (Test Example 4) The needle-shaped structures of Test Example 4 were obtained using the same materials and procedures as in Test Example 1, except that sucrose fatty acid ester, a surfactant, was added as an additive to the needle-shaped structure forming solution. The proportion of sucrose fatty acid ester in the needle-shaped structure forming solution in Test Example 4 was 1% by mass.

[0117] (Test Example 5) The needle-shaped structures of Test Example 5 were obtained using the same materials and procedures as in Test Example 1, except that sucrose fatty acid ester, a surfactant, was added as an additive to the needle-shaped structure forming solution. The proportion of sucrose fatty acid ester in the needle-shaped structure forming solution in Test Example 5 was 0.1% by mass.

[0118] (Test Example 6) The needle-like structures of Test Example 6 were obtained using the same materials and procedures as in Test Example 1, except that petrolatum was used as the oily material and sucrose fatty acid ester, a surfactant, was added as an additive to the needle-like structure forming solution. In the needle-like structure forming solution of Test Example 6, the proportion of petrolatum was 67% by mass, and the proportion of sucrose fatty acid ester was 1% by mass.

[0119] (Test Example 7) The needle-like structures of Test Example 7 were obtained using the same materials and procedures as in Test Example 6, except that the proportion of petrolatum in the needle-forming solution was changed. The proportion of petrolatum in the needle-forming solution in Test Example 7 was 50% by mass.

[0120] (Test Example 8) The needle-like structures of Test Example 8 were obtained using the same materials and procedures as in Test Example 6, except that the proportion of petrolatum in the needle-forming solution was changed. The proportion of petrolatum in the needle-forming solution in Test Example 8 was 33% by mass.

[0121] (Test Example 9) The needle-like structures of Test Example 9 were obtained using the same materials and procedures as in Test Example 6, except that the proportion of petrolatum in the needle-forming solution was changed. The proportion of petrolatum in the needle-forming solution in Test Example 9 was 10% by mass.

[0122] (Test Example 10) The needle-like structures of Test Example 10 were obtained using the same materials and procedures as in Test Example 6, except that the ratio of petrolatum and sucrose fatty acid ester in the needle-like structure forming solution was changed. In the needle-like structure forming solution of Test Example 10, the proportion of petrolatum was 50% by mass, and the proportion of sucrose fatty acid ester was 5% by mass.

[0123] (Test Example 11) The needle-like structures of Test Example 11 were obtained using the same materials and procedures as in Test Example 6, except that the ratio of petrolatum and sucrose fatty acid ester in the needle-like structure forming solution was changed. In the needle-like structure forming solution of Test Example 11, the proportion of petrolatum was 30% by mass, and the proportion of sucrose fatty acid ester was 5% by mass.

[0124] (Test Example 12) The needle-like structures of Test Example 12 were obtained using the same materials and procedures as in Test Example 6, except that the ratio of petrolatum and sucrose fatty acid ester in the needle-like structure forming solution was changed. In the needle-like structure forming solution of Test Example 12, the proportion of petrolatum was 10% by mass, and the proportion of sucrose fatty acid ester was 5% by mass.

[0125] (Moldability evaluation) <Mold releasability> For each test example, demolding was performed to separate the needle-like portion from the intaglio plate, and the ease of demolding was evaluated on a three-point scale. In the evaluation, 1 point was given if it was difficult to separate the needle-like portion from the intaglio plate and some samples had the needle-like portion split into multiple parts; 2 points were given if it was possible to separate the needle-like portion from the intaglio plate, but more than 10% of the samples had a missing portion of the needle-like portion; and 3 points were given if it was possible to separate the needle-like portion from the intaglio plate, and more than 90% of the samples had a needle-like portion without any missing parts.

[0126] <Followability> For each test example, the shape of the needle-like portion was observed, and its conformity to the shape of the recess was evaluated on a three-point scale. In the evaluation, 1 point was awarded if there were samples in which the needle-forming solution did not enter the recess and no needle-like protrusions were formed; 2 points were awarded if more than 10% of the samples had needle-like portions that differed from the shape of the recess; and 3 points were awarded if more than 90% of the samples had needle-like portions that matched the shape of the recess. Note that needle-like portions that differed from the shape of the recess included needle-like portions that were smaller or larger than the recess, and needle-like portions that did not conform to the recess because they had irregularities on the surface due to the inclusion of air bubbles, etc.

[0127] <Stability> For each test example, the shape of the needle-like portion was observed, and the stability of the shape across multiple samples was evaluated on a three-point scale. In the evaluation, a score of 1 was given if the proportion of needle-like portions formed in the desired shape was less than 50% of the multiple samples; a score of 2 was given if the proportion of needle-like portions formed in the desired shape was 50% or more but less than 85% of the multiple samples; and a score of 3 was given if the proportion of needle-like portions formed in the desired shape was 85% or more of the multiple samples. A needle-like portion with the desired shape is defined as a needle-like portion that is free of chips and matches the shape of the recess.

[0128] (Evaluation of shape disappearance rate) The needle-shaped portion of each test example was immersed in water, and the time required until the needle-shaped portion lost its shape, i.e., until it completely dissolved, was measured. In the evaluation, a measurement result of 3 minutes or more but less than 4 minutes was given 1 point, and a measurement result of 4 minutes or more was given 2 points. Note that for test examples 4, 5, 6, 10, 11, and 12, the desired shape of the needle-shaped portion could not be obtained, or the needle-shaped portion was brittle, making it difficult to conduct the test of immersing the needle-shaped portion in water while maintaining its shape, so the rate of shape disappearance was not measured.

[0129] As a reference example, a needle-shaped portion was prepared using an aqueous pullulan solution as the needle-forming solution, following the same procedure as in Test Example 1. The needle-shaped portion in the reference example was formed solely from water-soluble materials, without any oily materials or additives. When the needle-shaped portion of the reference example was immersed in water, the time required for it to lose its shape was measured, and the result was approximately 1 minute.

[0130] (Evaluation results) Table 1 shows the type of oily material, the proportion of oily material, the evaluation results for moldability and shape loss rate, and the overall evaluation for each test example. The overall evaluation is the sum of the scores for each evaluation.

[0131] [Table 1]

[0132] As shown in Table 1, the ease of forming the needle-like structures varies depending on the proportion of oily material and the presence and amount of surfactant added. Overall, a smaller proportion of oily material tends to improve the moldability of the needle-like structures. When palm oil was the oily material, no contribution of sucrose fatty acid ester to improving moldability was confirmed. On the other hand, when petrolatum was the oily material, the addition of sucrose fatty acid ester facilitated the mixing of petrolatum into the needle-forming solution, and it was observed that good moldability was easily obtained when the addition ratio of sucrose fatty acid ester was around 1% by mass.

[0133] Furthermore, regarding the rate of shape disappearance, in all the test examples in which measurements were taken, it was confirmed that the time required for the shape to disappear was longer compared to the needle-shaped portion of the reference example consisting only of water-soluble material, meaning that the rate at which the needle-shaped portion dissolved was slower. A score of 8 or higher in the overall evaluation is desirable because it indicates that the needle-shaped portion possesses a well-balanced set of characteristics related to each evaluation. [Explanation of Symbols]

[0134] 10,11...transplant 20... Needle-shaped part 21...Water-soluble part 22…Oil-based parts 23…Internal hole 25…Containment port 26…Opening 30... Circuit board section 50...implant 51…Auxiliary fluid

Claims

1. A needle-shaped portion having a shape capable of piercing living tissue, the needle-shaped portion being configured to hold a graft containing a group of cells, which is an aggregate of cells, inside, The needle-shaped portion has a water-soluble portion containing a water-soluble material and an oily portion containing an oily material. The water-soluble portion has holes for containing the transplanted material, and the oily portion covers the inner surface of the holes. transplanter.

2. A needle-shaped portion having a shape capable of piercing living tissue, the needle-shaped portion being configured to hold a graft containing a group of cells, which is an aggregate of cells, inside, The needle-shaped portion has a water-soluble portion containing a water-soluble material and an oily portion containing an oily material. The oily portion is located at the base of the needle-shaped portion. transplanter.

3. A needle-shaped portion having a shape capable of piercing living tissue, the needle-shaped portion being configured to hold a graft containing a group of cells, which is an aggregate of cells, inside, The needle-shaped portion has a water-soluble portion containing a water-soluble material and an oily portion containing an oily material. The oily portion is located at the tip of the needle-shaped portion, The water-soluble portion is configured to hold the transplanted material inside. transplanter.

4. The aforementioned water-soluble material includes a water-soluble polymer. The oily material includes at least one of vegetable oils, animal oils, mineral oils, and oils synthesized using these as raw materials. The transplanter according to any one of claims 1 to 3.

5. The proportion of the oily material in the needle-shaped portion is 60% by mass or less. The transplanter according to any one of claims 1 to 4.

6. The base portion supports the base end of the needle-shaped portion, The material of the substrate portion includes a water-soluble material and an oil-based material. The transplanter according to any one of claims 1 to 5.

7. The proportion of the oily material in the substrate portion is different from the proportion of the oily material in the needle-shaped portion. The transplanter according to claim 6.

8. The needle-shaped portion comprises multiple needle-shaped parts, The plurality of needle-shaped portions include a first needle-shaped portion and a second needle-shaped portion, The proportion of the oily material in the first needle-shaped portion is different from the proportion of the oily material in the second needle-shaped portion. The transplanter according to any one of claims 1 to 7.

9. It has a needle-like portion that is shaped to pierce living tissue and is configured to hold a graft containing a group of cells, which is an aggregate of cells, inside. The needle-shaped portion has a water-soluble portion containing a water-soluble material and an oily portion containing an oily material. A method for manufacturing a transplanter, wherein the water-soluble portion has a hole for containing the transplant, and the oily portion covers the inner surface of the hole, The process includes forming the needle-shaped portion by filling the recess of a recessed plate, which has a recess corresponding to the shape of the needle-shaped portion, with the water-soluble material and the oil-based material. A method for manufacturing a transplanting device.

10. It has a needle-like portion that is shaped to pierce living tissue and is configured to hold a graft containing a group of cells, which is an aggregate of cells, inside. The needle-shaped portion has a water-soluble portion containing a water-soluble material and an oily portion containing an oily material. A method for manufacturing a transplanter in which the oily portion is located at the base of the needle-shaped portion, The process includes forming the needle-shaped portion by filling the recess of a recessed plate, which has a recess corresponding to the shape of the needle-shaped portion, with the water-soluble material and the oil-based material. A method for manufacturing a transplanting device.

11. It has a needle-like portion that is shaped to pierce living tissue and is configured to hold a graft containing a group of cells, which is an aggregate of cells, inside. The needle-shaped portion has a water-soluble portion containing a water-soluble material and an oily portion containing an oily material. The oily portion is located at the tip of the needle-shaped portion, A method for manufacturing a transplanter, wherein the water-soluble portion is configured to hold the transplant inside, The process includes forming the needle-shaped portion by filling the recess of a recessed plate, which has a recess corresponding to the shape of the needle-shaped portion, with the water-soluble material and the oil-based material. A method for manufacturing a transplanting device.

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