Manufacturing method of transfer quipment, sterilization method thereof, and medical instrument package

Abstract

To achieve a reduced diameter and reduced invasion of transfer equipment for transferring a medical sheet used for organ transplantation to a treatment object part of a living body.SOLUTION: A support part of transfer equipment is deformed into a curved shape so that the two sides in a width direction are opposed to each other on a revere face. In this state, a shaft provided with the support part is moved from a second position in a tip direction to a first position in a base end direction. Thereby, the support part is housed in an external cylinder so that the two ends opposed to each other form a pair of separation parts which are separated from an inner peripheral surface of the external cylinder and protrude inside the external cylinder. Then, the external cylinder, the shaft, and the support part in this state are subjected to sterilization treatment.SELECTED DRAWING: Figure 14

Description

[Technical field]

[0001] The present invention relates to a method for producing a transfer device for transferring a medical sheet to a treatment target part of a living body and a method for sterilizing the same.The present invention also relates to a medical device package comprising a transfer device and a packaging material. [Background technology]

[0002] Patent Document 1 discloses a transfer device for transferring a medical sheet (cell sheet) used, for example, in organ transplantation to a treatment target part of a living body. This transfer device comprises an outer tube, a sliding member slidably supported within the outer tube, and a sheet support member provided at the tip of the sliding member. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2009-000511 A Summary of the Invention [Problem to be solved by the invention]

[0004] It is desirable to have smaller, less invasive delivery instruments. [Means for solving the problem]

[0005] (1) A first aspect of the present disclosure is a method for manufacturing a transfer device for transferring a medical sheet to a treatment target part of a living body. Here, the transfer device comprises an outer tube having a tip opening, a shaft extending in the axial direction of the outer tube and arranged inside the outer tube movably along the axial direction, and a carrier member having a sheet-shaped support portion arranged at the tip of the shaft, wherein the support portion has a support surface capable of holding the medical sheet, a front surface including the support surface, and a back surface opposite to the front surface, the width of the support portion in a direction perpendicular to the extension direction of the shaft is greater than the inner peripheral length of the outer tube, the support portion has a support base portion having the support surface, and a pair of protrusions protruding upward from both sides of the support base portion in the width direction of the support portion, and at a first position where the shaft is moved in a base end direction relative to the outer tube so that the support portion is accommodated within the outer tube, the support portion is accommodated within the outer tube in a curved and deformed state, and at a second position where the shaft is moved in a tip direction relative to the outer tube so that the support portion protrudes from the tip opening of the outer tube, the support portion is deployed by being exposed in the tip direction from the outer tube.

[0006] The manufacturing method includes an accommodating step of accommodating the support part within the outer tube by bending and deforming the support part so that both widthwise ends of the support part face each other on the back surface, and moving the shaft from the second position to the first position so that the opposing both ends form a pair of separated portions that separate from the inner surface of the outer tube and protrude into the interior of the outer tube; and a shaping step of shaping the pair of protrusions by subjecting the outer tube, shaft, and support part to a heating process that increases the temperature of the outer tube, shaft, and support part while the support part has formed the pair of separated portions within the outer tube.

[0007] According to the above manufacturing method, the shape of the pair of protrusions is stabilized in the shape formed during the heating process. Therefore, when the medical sheet is transported, the support part is smoothly accommodated in the outer cylinder by moving the shaft from the second position to the first position. This allows the transport device to be made thinner and less invasive.

[0008] (2) In the method for producing a transfer device according to the above item (1), the temperature increasing treatment in the shaping step may be a sterilization treatment.

[0009] In this case, the pair of protrusions can be shaped simultaneously with the sterilization process, which allows the transfer device to be manufactured efficiently.

[0010] (3) In the method for producing a transfer device according to the above item (2), the sterilization treatment may be performed by radiation sterilization.

[0011] In this case, the shape of the pair of protrusions becomes more stable when shaped.

[0012] (4) In the method for manufacturing a transferring device according to any one of items (1) to (3) above, in the accommodating step, at least a part of the portions of the pair of spaced apart portions that face each other may be brought into contact with each other.

[0013] (5) A second aspect of the present disclosure is a medical device package comprising a transfer device for transferring a medical sheet to a treatment target part of a living body, and a packaging material in which the transfer device is packaged. Here, the transfer device comprises an outer tube having a tip opening, a shaft extending in the axial direction of the outer tube and arranged inside the outer tube movably along the axial direction, and a carrier member having a sheet-shaped support portion arranged at the tip of the shaft, wherein the support portion has a support surface capable of holding the medical sheet, a front surface including the support surface, and a back surface opposite to the front surface, the width of the support portion in a direction perpendicular to the extension direction of the shaft is greater than the inner peripheral length of the outer tube, the support portion has a support base portion having the support surface, and a pair of protrusions protruding upward from both sides of the support base portion in the width direction of the support portion, and at a first position where the shaft is moved in a base end direction relative to the outer tube so that the support portion is accommodated within the outer tube, the support portion is accommodated within the outer tube in a curved and deformed state, and at a second position where the shaft is moved in a tip direction relative to the outer tube so that the support portion protrudes from the tip opening of the outer tube, the support portion is deployed by being exposed in the tip direction from the outer tube.

[0014] The medical device package is configured by containing the sterilized outer cylinder, the shaft, and the support part in the packaging material. In an unopened state before the packaging material is opened, the shaft is located at the first position, and the support part is curved and deformed and contained in the outer cylinder so that the pair of protrusions are separated from the inner circumferential surface of the outer cylinder to form a pair of separated parts that protrude into the outer cylinder.

[0015] The support portion has a pair of protrusions that are shaped during the temperature rise treatment. In this case, the shape of the pair of protrusions is stabilized in the shape that is shaped during the temperature rise treatment.

[0016] Furthermore, if the support parts are kept housed in the outer tube prior to using the transfer device, the shape of the pair of protrusions becomes more stable. Therefore, when the medical sheet is transferred using the transfer device removed from the packaging material, the support parts are smoothly housed in the outer tube by moving the shaft from the second position to the first position. This allows the transfer device to be made thinner and less invasive.

[0017] (6) A third aspect of the present disclosure is a method for sterilizing a transfer device for transferring a medical sheet to a treatment target part of a living body. Here, the transfer device comprises an outer tube having a tip opening, a shaft extending in the axial direction of the outer tube and arranged inside the outer tube movably along the axial direction, and a carrier member having a sheet-shaped support portion arranged at the tip of the shaft, wherein the support portion has a support surface capable of holding the medical sheet, a front surface including the support surface, and a back surface opposite to the front surface, the width of the support portion in a direction perpendicular to the extension direction of the shaft is greater than the inner peripheral length of the outer tube, the support portion has a support base portion having the support surface, and a pair of protrusions protruding upward from both sides of the support base portion in the width direction of the support portion, and at a first position where the shaft is moved in a base end direction relative to the outer tube so that the support portion is accommodated within the outer tube, the support portion is accommodated within the outer tube in a curved and deformed state, and at a second position where the shaft is moved in a tip direction relative to the outer tube so that the support portion protrudes from the tip opening of the outer tube, the support portion is deployed by being exposed in the tip direction from the outer tube.

[0018] The sterilization method includes an accommodating step of accommodating the support part within the outer tube by bending and deforming the support part so that both widthwise ends of the support part face each other on the back surface, and moving the shaft from the second position to the first position so that the opposing both ends form a pair of separated portions that separate from the inner surface of the outer tube and protrude into the interior of the outer tube; and a sterilization step of subjecting the outer tube, the shaft and the support part to a sterilization process that increases the temperature of the outer tube, the shaft and the support part while the support part has formed the pair of separated portions within the outer tube, and shaping the pair of protrusions based on the temperature increase.

[0019] According to this sterilization method, the shape of the pair of protrusions is stabilized in the shape that was formed during the sterilization process. Therefore, when the medical sheet is transferred, the support part is smoothly accommodated in the outer cylinder by moving the shaft from the second position to the first position. This allows the transfer instrument to be made thinner and less invasive.

[0020] Moreover, the shaping of the pair of protrusions can be carried out simultaneously with the sterilization treatment, so that a sterilized transfer instrument can be obtained efficiently.

[0021] (7) The method for sterilizing a transfer device according to the above item (6) may further include a packaging step of packaging the transfer device in a packaging material, and the sterilization step may be carried out after the packaging step.

[0022] In this case, the transport device is kept packaged in the packaging material before and after the sterilization process, and therefore the transport device can be kept clean. Effect of the Invention

[0023] According to the present invention, since the support portion can be smoothly housed within the outer cylinder, the diameter of the delivery instrument can be made thinner, making it less invasive. [Brief description of the drawings]

[0024] [Figure 1] FIG. 1 is a perspective view of a delivery device according to an embodiment of the present invention. [Diagram 2] FIG. 2 is an exploded perspective view of the delivery device of FIG. [Diagram 3] FIG. 3 is a plan view of the tip of the delivery device of FIG. [Figure 4] FIG. 4 is a vertical cross-sectional view taken along line IV-IV in FIG. [Diagram 5] FIG. 5 is a cross-sectional view taken along line VV in FIG. [Figure 6] FIG. 6 is a flow chart showing the steps of a method for transferring a medical sheet using the transfer device of FIG. [Figure 7] FIG. 7 is an explanatory diagram of the sheet placing step. [Figure 8] FIG. 8 is an explanatory diagram of the accommodation step. [Figure 9] FIG. 9 is a cross-sectional view taken along line IX-IX in FIG. [Figure 10] FIG. 10 is an explanatory diagram of the placement process. [Figure 11] FIG. 11 is an explanatory diagram of the development process. [Figure 12] FIG. 12 is an explanatory diagram of the movement process. [Figure 13] FIG. 13 is an explanatory diagram of the removal step. [Figure 14] FIG. 14 is a flow chart showing the steps of a manufacturing and sterilization method for obtaining the transfer device of FIG. [Figure 15] FIG. 15 is a schematic perspective view of a medical device package in which a sterilized transfer device is wrapped in a packaging material. [Figure 16] FIG. 16 is a flow chart showing steps of a method for manufacturing a transfer device in an embodiment different from that of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] As shown in Fig. 1, the transfer device 10 according to this embodiment is a medical device for transferring a medical sheet 300 to a treatment target part of a living body. The transfer device 10 is used, for example, in the treatment of severe heart failure caused by ischemic heart disease. In this case, the medical sheet 300 is transplanted to a transplant target part 402 of a heart 400 (a treatment target part of a living body) (see Fig. 12). The transfer device 10 can attach multiple medical sheets 300 to the transplant target part 402.

[0026] Such medical sheet 300 includes pharmaceuticals for medical use, regenerative medicine products, medical devices, etc. The medical sheet 300 is formed in a sheet shape such as a film or membrane (gel-like substance). The medical sheet 300 may be reinforced by applying fibrin or the like. Regenerative medicine products containing cells include, for example, cell sheets (sheet-shaped cell cultures), spheroids, etc. The cell sheet can be formed by culturing autologous cells or allogeneic cells. The cells constituting the cell sheet include, for example, somatic stem cells (adult stem cells), mesenchymal stem cells, or cardiomyocytes derived from iPS cells (induced pluripotent stem cells). The somatic stem cells preferably include skeletal myoblasts (myoblast cells).

[0027] The medical sheet 300 may contain a tissue adhesive, a local anesthetic, etc. The thickness of the medical sheet 300 is, for example, about 100 μm, and the diameter of the medical sheet 300 is, for example, about 60 mm. However, the thickness and diameter (size) of the medical sheet 300 can be set appropriately.

[0028] The medical sheet 300 may be a sheet to be transplanted into an organ (such as the lung, liver, pancreas, kidney, small intestine, or esophagus) other than the heart 400. Furthermore, the medical sheet 300 may be a sheet for preventing adhesions, for example, so long as it is for medical use.

[0029] 1 and 2, the transportation instrument 10 includes an instrument body 12, an endoscope 14, and a fixing member 16. The instrument body 12 includes a first carrier member 18, a second carrier member 20, and an outer cylinder 22. Note that the transportation instrument 10 is not limited to including the endoscope 14.

[0030] In FIG. 2, the first carrier member 18 includes a first shaft 24 and a first support 26 .

[0031] The first shaft 24 is a tubular body (a circular tube member in this embodiment) having a first lumen 28. The first lumen 28 opens at the tip (the end in the direction of the arrow X1) of the first shaft 24 and at the base end (the end in the direction of the arrow X2) of the first shaft 24. An airtight valve body 55 that is in close contact with the outer circumferential surface of the second shaft 48 is provided at the base end of the first shaft 24. A marker 551 is provided on the outer circumferential surface of the valve body 55. When using the transfer device 10, the user can see the marker 551. Note that the first shaft 24 is not limited to a tubular body, and may not be a tubular body.

[0032] The first shaft 24 extends in the axial direction of the outer cylinder 22 and is disposed inside the outer cylinder 22 so as to be movable along the axial direction. The first shaft 24 is made of, for example, a resin material. The constituent material of the first shaft 24 is not particularly limited, but examples thereof include polyethylene, polypropylene, fluororesin, polyethylene terephthalate, polymethyl methacrylate, polyamide resin, polystyrene, polycarbonate, polyimide, polyetherimide, polyether ether ketone, polyvinyl chloride, ABS resin, polyamide elastomer, and polyester elastomer. The first shaft 24 may be made of a metal material.

[0033] The first shaft 24 may be flexible. The first shaft 24 may have a flexible tube portion capable of retaining a bent shape. In this case, the first shaft 24 can be bent into an appropriate shape within the body cavity and can retain the bent shape.

[0034] As shown in Figs. 2 to 4, the first support part 26 is attached to the tip part of the first shaft 24. The first support part 26 is made of, for example, a resin material. The first support part 26 is capable of holding a medical sheet 300. The first support part 26 is formed by folding a flexible resin sheet material (film material) into a predetermined shape. The first support part 26 is formed, for example, by forming the sheet material into a predetermined shape using a sheet forming die. The thickness of the sheet material is not particularly limited, but is preferably set to, for example, 100 µm or more and 200 µm or less. The first support part 26 has a first joint part 30 and a first support body 32.

[0035] The constituent material of the first support section 26 is not particularly limited, but is preferably transparent, and examples of the constituent material include polyethylene, polycarbonate, polyamide, polystyrene, polypropylene, polyacetal resin, polyimide, polyetherimide, polyether ether ketone, polyethylene terephthalate, fluororesin, etc. The first support section 26 may be in a mesh shape.

[0036] In Fig. 4, the first joint part 30 is bonded to the inner circumferential surface of the tip part of the first shaft 24 by an adhesive. The adhesive is not particularly limited, but examples thereof include a UV adhesive, a hot melt adhesive, and an instant adhesive (e.g., a cyanoacrylate instant adhesive). The first joint part 30 may be heat fused to the inner circumferential surface of the first shaft 24. The first support part 26 may be detachable from the tip part of the first shaft 24.

[0037] As shown in Fig. 2, the first support body 32 extends from the first joint portion 30 in the distal direction. The first support body 32 has a base end support portion 34, an intermediate support portion 36, a protruding portion 38, and a distal end support portion 42. The first support body 32 has a first support surface 261. The marker 551 is arranged so that the marker 551 of the first shaft 24 faces upward when the first support surface 261 faces upward. In other words, the marker 551 allows the user to confirm the direction of the first support surface 261 in the first support portion 26.

[0038] As shown in Fig. 3, the base end support part 34 is formed to be wider in the extension direction. In other words, both sides in the width direction of the base end support part 34 are tapered toward the first joint part 30 (see Fig. 2). The intermediate support part 36 is formed to be tapered so that the width gradually decreases from the tip toward the base end (arrow X2 direction).

[0039] The tip support portion 42 is connected to the tip of the intermediate support portion 36 and the tips of the pair of protruding portions 38. The tip support portion 42 protrudes in an arc shape toward the tip direction (arrow X1 direction). That is, when viewed from a direction perpendicular to the first support surface 261 shown in FIG. 3, the tip support portion 42 of the first support portion 26 is in the shape of an arc connecting the pair of protruding portions 38.

[0040] 4, the base end support portion 34 extends from the tip of the first joint portion 30 toward the tip direction (arrow X1 direction) so as to generally follow the axis Ax of the first shaft 24. The intermediate support portion 36 extends from the tip of the base end support portion 34 toward the tip direction (arrow X1 direction) to intersect with the axis Ax of the first shaft 24 and toward the tip direction of the first support portion 26 (arrow X1 direction).

[0041] 2 and 3, the pair of protrusions 38 protrude upward (in the direction of arrow Y) and inward in the width direction of the intermediate support part 36 from both sides in the width direction of the intermediate support part 36 perpendicular to the moving direction of the first shaft 24. The protrusions 38 are arc-shaped and bulge outward in a convex manner in a direction away from the first support surface 261.

[0042] In FIG. 3, the direction perpendicular to the axial direction of the first shaft 24 (W direction) is the width direction of the first support part 26. Therefore, the pair of protrusions 38 are provided on both sides of the first support part 26 in the width direction. The W direction is also the width direction of other components (such as the outer tube 22). In this embodiment, the first support part 26 has a pair of protrusions 38, and W1 in FIG. 3 is the width of the portion where the width of the first support part 26 is maximum when the first support part 26 is developed in a plane. That is, the width W1 of the first support part 26 is the maximum width of the first support part 26P in a plane state before the pair of protrusions 38 are formed (before bending). The width W1 of the first support part 26 is greater than the inner circumferential length L of the outer tube 22 (see FIG. 9). In FIG. 9, the inner circumferential length L of the outer tube 22 is the length of the inner circumferential surface along the circumferential direction of the outer tube 22 (L=2πR). R is the radius of the inner cavity 78 of the outer tube 22.

[0043] As shown in FIG. 5, the first support portion 26 has a support base portion 264 having a first support surface 261. The pair of protrusions 38 protrude upward from both sides of the support base portion 264 in the width direction of the first support portion 26. The support base portion 264 and the pair of protrusions 38 are connected via a pair of curved portions 444 curved in an arc shape. Each curved portion 444 is curved so that a part of the front surface 461 of the first support portion 26 forms the inside of the curved portion 444 (the inside of the curved shape) and a part of the back surface 462 of the first support portion 26 forms the outside of the curved portion 444 (the outside of the curved shape). Each of the pair of curved portions 444 bends the pair of protrusions 38 against the first support surface 261 (the intermediate support portion 36) of the first support portion 26 (see FIG. 5).

[0044] The first support body 32 has a front surface 461 that faces upward (in the direction of arrow Y) and includes the first support surface 261, and a back surface 462 that is the opposite surface to the front surface 461. The first support surface 261 is a substantially flat surface that is continuous with the upper surface of the base end support part 34, the intermediate support part 36, and the upper surfaces of the tip support part 42. A lubricant may be applied to the first support surface 261 so that a second support part 50 of the second carrier member 20, which will be described later, can slide smoothly on the first support surface 261.

[0045] As shown in FIG. 2, the second carrier member 20 includes a second shaft 48 , a second support portion 50 , and a hub 52 .

[0046] The second shaft 48 is a tubular body (a circular tube member in this embodiment) having a second lumen 57. The length of the second shaft 48 along the axial direction is longer than the length of the first shaft 24 along the axial direction. The second shaft 48 is inserted into the first lumen 28 of the first shaft 24 (see Figs. 1 and 4). In other words, the distal end of the second shaft 48 protrudes in the distal direction (arrow X1 direction) from the distal end opening of the first shaft 24. The proximal end of the second shaft 48 protrudes in the proximal direction (arrow X2 direction) from the proximal end opening of the first shaft 24 (see Fig. 1). The second shaft 48 extends along the first shaft 24 and is provided movably along the first shaft 24. The second shaft 48 is not limited to a tubular body and may not be a tubular body.

[0047] The second shaft 48 is configured so as to be able to follow the shape of the first support portion 26. As the constituent material of the second shaft 48, for example, a material that is more flexible than the constituent material of the first shaft 24 is selected. Specifically, as the constituent material of the second shaft 48, for example, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyvinyl chloride, polybutadiene, silicone rubber, metal coil (including composite with resin), etc. can be mentioned. The second shaft 48 is flexible.

[0048] 4, the second shaft 48 has a carrier holding portion 54 and a pressing portion 56 formed by the tip portion of the second shaft 48. The pressing portion 56 is formed from an elastic body such as an elastomer material. The pressing portion 56 presses the first support portion 26 against the inner surface of the outer tube 22 in a state in which the first support portion 26 is housed inside the outer tube 22.

[0049] The tip of the carrier holding part 54 has a pressing surface 58. The carrier holding part 54 is capable of pressing the outer peripheral end surface of the medical sheet 300 supported by the first support part 26 in the tip direction (arrow X1 direction) with the pressing surface 58. In this embodiment, the pressing part 56 is provided with the carrier holding part 54 that supports the second support part 50. The carrier holding part 54 has a pressing surface 58 and an attachment hole 60.

[0050] In Fig. 4, the pressing surface 58 is provided on the tip surface of the carrier holding part 54. An attachment hole 60 opens in the pressing surface 58. The second support part 50 is attached to the pressing surface 58. The pressing surface 58 presses the outer peripheral end surface of the medical sheet 300 in the tip direction (the direction of the arrow X1) (see Fig. 12).

[0051] 2 to 4, the second support part 50 is configured in a flexible sheet shape. The second support part 50 has a second joint part 70 and a second support body 72. The second joint part 70 is provided at the base end of the second support part 50. The second joint part 70 is provided at the base end of the second support body 72. The second joint part 70 is inserted into the mounting hole 60 of the carrier holding part 54 and is, for example, bonded. The second joint part 70 may be bonded to the mounting hole 60 of the carrier holding part 54 by an appropriate bonding method other than bonding. Furthermore, the second support part 50 may be molded integrally with the carrier holding part 54.

[0052] The second support body 72 extends from the second joint 70 in the tip direction (the direction of arrow X1). The length of the second support body 72 in the extending direction from the second joint 70 is shorter than the length of the first support body 32 in the extending direction from the first joint 30. A second support surface 74 for placing the medical sheet 300 is provided on the upper surface of the second support body 72. The second support surface 74 is a substantially flat surface. The second support body 72 is smaller than the first support body 32. In other words, the area of ​​the second support surface 74 is smaller than the area of ​​the first support surface 261.

[0053] In FIG. 2, the hub 52 is attached to the proximal end of the second shaft 48 .

[0054] 1 and 2, the outer tube 22 is a cylindrical member having a cavity 78. The cavity 78 has a tip opening 80 that opens at the tip (end in the direction of arrow X1) of the outer tube 22. The cavity 78 opens at the base end (end in the direction of arrow X2) of the outer tube 22. The outer tube 22 is flexible. The outer tube 22 may be made of the same material as the first shaft 24 described above. The first shaft 24 is inserted into the cavity 78 of the outer tube 22. The length of the outer tube 22 in the axial direction is shorter than the length of the first shaft 24 in the axial direction. The base end of the outer tube 22 is provided with an airtight valve body 84 that is in close contact with the outer circumferential surface of the first shaft 24.

[0055] 2 and 4, the tip surface of the outer cylinder 22 extends along a direction perpendicular to the axial direction of the outer cylinder 22. In FIG.

[0056] As shown in Fig. 2, the endoscope 14 has a long endoscope body 86. The tip of the endoscope body 86 is fixed to the outer peripheral surface of the outer tube 22 by a fixing member 16 (see Fig. 1). An objective lens 88 provided on the tip surface of the endoscope body 86 faces the tip direction of the outer tube 22 (the direction of the arrow X1). The tip of the endoscope body 86 is fixed to a middle part of the outer tube 22 in the axial direction. However, the tip of the endoscope body 86 may be fixed to the tip of the outer tube 22.

[0057] The fixing member 16 includes, for example, a fixed cylinder 90 and a fixed tube 92. The fixed cylinder 90 is made of, for example, a hard resin material. The endoscope main body 86 can be inserted into the inner cavity of the fixed cylinder 90. The fixed cylinder 90 is arranged along the longitudinal direction of the outer cylinder 22. The fixed tube 92 is a tube for fixing the fixed cylinder 90 to a predetermined position of the outer cylinder 22. The fixed tube 92 is, for example, a heat shrink tube. The method of fixing the tip portion of the endoscope main body 86 to the outer cylinder 22 can be set appropriately.

[0058] Next, a method for transferring the medical sheet 300 to a treatment target part of a living body will be described. Specifically, as shown in Fig. 10 to Fig. 13, a method for transferring the medical sheet 300 to a transplant target part 402 of a heart 400 (treatment target part of a living body) by thoracoscopic surgery will be described. As shown in Fig. 6, the transfer method according to this embodiment includes a preparation step, a sheet placement step, a storage step, a positioning step, a deployment step, a movement step, and a removal step.

[0059] First, in a preparation step (step S1), the transfer device 10 according to the present embodiment described above is prepared. In the following, the state shown in FIG. 1 will be described as the initial state of the transfer device 10. In the initial state, the first shaft 24 and the second shaft 48 are moved in the distal direction (arrow X1 direction) relative to the outer tube 22, and the first support portion 26 and the second support portion 50 are in a protruding position (second position) protruding in the distal direction from the distal opening 80 of the outer tube 22. Each of the first and second support portions 26, 50 is exposed in the distal direction from the outer tube 22 and deployed, and the second support portion 50 is disposed on the first support surface 261 of the first support portion 26. That is, the second support portion 50 is disposed in a retracted position overlapping the first support surface 261 of the first support portion 26. At this time, the base end portion of the carrier holding portion 54 is inserted into the first inner cavity 28 of the first shaft 24.

[0060] 7, the medical sheet 300 placed in the petri dish 401 is placed on the second support surface 74. The medical sheet 300 protrudes outward from the second support portion 50 when placed on the second support surface 74. The first support surface 261 supports the protruding portion 302 of the medical sheet 300 that protrudes outward from the second support portion 50.

[0061] Thereafter, in the accommodation step (step S3 in FIG. 6), the medical sheet 300 is accommodated in the outer cylinder 22 together with the first support part 26 and the second support part 50 to a accommodated position (first position) as shown in FIG. 8. Specifically, the first shaft 24 of the first carrier member 18 and the second shaft 48 of the second carrier member 20 are moved together in the base end direction (the direction of the arrow X2) relative to the outer cylinder 22.

[0062] Then, the base end support portion 34 (see FIG. 2) of the first support portion 26 is drawn in the base end direction from the tip opening 80 of the outer tube 22. At this time, the tapered both sides of the base end support portion 34 come into contact with the tip opening 80 of the outer tube 22, so that a force acts on the base end support portion 34 to curl the base end support portion 34 along the circumferential direction of the outer tube 22. Therefore, the base end support portion 34 is smoothly drawn into the outer tube 22 while curling. At this time, the first support portion 26 is accommodated in the outer tube 22 while curling into a cone shape such that the tip side has a large diameter and the base end support portion 34 has a small diameter.

[0063] When the base end support portion 34 of the first support portion 26 is deformed, a force acts on the middle support portion 36 of the first support portion 26 to curl up along the circumferential direction of the outer tube 22, so that the middle support portion 36 (see FIG. 2) is drawn into the outer tube 22 while curling up. At this time, the middle support portion 36 is deformed into a cylindrical shape along the inner surface of the outer tube 22. Each of the pair of protruding portions 38 is curved so that the surface 461 of the first support portion 26 is on the inside and the back surface 462 of the first support portion 26 is on the outside. As shown in FIG. 9, the back surfaces 462 on both sides in the width direction of the first support portion 26 come into contact with each other on a virtual line L2 extending in a direction perpendicular to the central axis of the outer tube 22. One protruding portion 38 and the other protruding portion 38 come into contact with each other and are accommodated downward (first support surface 261, surface 461).

[0064] As a result, the back surface 462 of the first support portion 26 is curved in intimate contact with the inner surface of the outer tube 22, and each protrusion 38 is further curved so as to bend back toward the center of the outer tube 22, with the free end of each protrusion 38 being positioned below the central axis of the outer tube 22. In other words, the first support portion 26 is curved into a heart shape that fits along the inner surface of the outer tube 22.

[0065] The heart shape refers to a generally circular shape consisting of a convexly curved shape on one side and two convexly curved shapes on the other side opposite to the one side. When a heart shape is formed in the lumen 78 of the tubular body (outer cylinder 22), the two convexly curved shapes protruding to the other side along the inner surface of the tubular body approach each other and part of the circumferential surface comes into contact with each other, so that the overall outline becomes a generally circular shape along the inner surface of the tubular body (see the shape of the first support part 26 in FIG. 9).

[0066] As the first support part 26 is curved and deformed, the second support part 50 is also curved and deformed along the first support part 26 on the inside (surface 461 side) of the first support part 26. As the first support part 26 and the second support part 50 are curved and deformed, the medical sheet 300 is deformed into a shape corresponding to the shapes of the first support body 32 and the second support body 72, and the medical sheet 300 is contained within the outer cylinder 22.

[0067] 8, the accommodating step is completed when the entire first support part 26 is completely inserted into the outer tube 22. When the accommodating step is completed, a part of the first support part 26 may protrude from the tip opening 80 of the outer tube 22. In this case, the state in which a part of the first support part 26 protrudes from the tip opening 80 of the outer tube 22 is the first position of the first support part 26.

[0068] Thereafter, in a placement step (step S4 in FIG. 6), as shown in FIG. 10, the transfer instrument 10 is inserted into the thoracic cavity 410 through the incision 409 in the chest 408. At this time, the tip of the transfer instrument 10 is positioned near the transplant target portion 402 in the heart 400, and the tip of the endoscope 14 is positioned inside the thoracic cavity 410. Note that before inserting the transfer instrument 10 into the thoracic cavity 410, a liquid supply instrument (not shown) may be connected to the connection port of the hub 52 to introduce liquid (e.g., physiological saline).

[0069] Next, in the unfolding step (step S5 in FIG. 6), the first support part 26, the second support part 50, and the medical sheet 300 are unfolded as shown in FIG. 11. Specifically, in the unfolding step, the first shaft 24 is grasped and moved toward the tip (arrow X1 direction) relative to the outer tube 22. As a result, the valve body 55 of the first shaft 24 moves the second shaft 48 together with the first shaft 24 toward the tip (arrow X1 direction). Then, the first support part 26 exposed from the tip opening 80 of the outer tube 22 returns to its original shape by a restoring force. In the second position where the first support part 26 is unfolded, the second support part 50 spreads out into a planar shape.

[0070] In the unfolding step, the second carrier member 20 has the second support surface 74, on which the medical sheet 300 is placed, positioned entirely above the first support surface 261. At this time, the medical sheet 300 is supported by the first support surface 261 and the second support surface 74. This makes it possible to prevent wrinkles from forming in the protruding portion 302 of the medical sheet 300 before the medical sheet 300 is transferred to the transplantation target portion 402 of the heart 400.

[0071] 12, by moving the second carrier member 20 in the distal direction (arrow X1 direction) relative to the first carrier member 18, the second support part 50 on which the medical sheet 300 is placed moves from the retracted position to the advanced position, and the second support part 50 protrudes in the distal direction (arrow X1 direction) beyond the tip of the first support part 26. Specifically, in the moving step, the second shaft 48 is moved in the distal direction relative to the first shaft 24.

[0072] As a result, the second support part 50 moves in the distal direction (direction of arrow X1) relative to the first support part 26. At this time, when the distal end surface of the carrier holding part 54 (pressing part 56) presses the outer peripheral end surface of the medical sheet 300 in the distal direction, the entire medical sheet 300 is positioned in the distal direction further than the first support part 26. In this moving step, the medical sheet 300 is moved above the transplant target part 402 of the heart 400, and the overhanging part 302 of the medical sheet 300 is brought into contact with the transplant target part 402.

[0073] Then, in the removal step (step S7 in FIG. 6), as shown in FIG. 13, the second carrier member 20 is moved from the second position to the first position to remove the second support part 50 from between the transplantation target part 402 and the medical sheet 300. Then, the entire medical sheet 300 comes into contact with the surface of the transplantation target part 402. This completes the transfer of the medical sheet 300 to the transplantation target part 402. Thereafter, the transferring instrument 10 is removed from the chest 408 with the first support part 26 and the second support part 50 housed within the outer cylinder 22.

[0074] Next, a description will be given of a manufacturing method and a sterilization method for the transfer device 10. As shown in Fig. 14, the manufacturing method and the sterilization method according to this embodiment include a housing step (step S10), a packaging step (step S15), and a shaping step (step S20).

[0075] Before the shaping step is performed, the front surface 461 and the back surface 462 of the first support part 26 are flat surfaces. In the accommodation step, the worker curves and deforms the first support part 26 (flat material sheet) having such a shape so that the back surfaces 462 of both widthwise sides face each other. Next, the worker moves the first shaft 24 of the first carrier member 18 and the second shaft 48 of the second carrier member 20 together to a first position in the base end direction (arrow X2 direction) relative to the outer tube 22, similar to the accommodation step (step S3 in FIG. 6) in the transfer method. However, when the manufacturing method and the sterilization method are performed, the medical sheet 300 is not supported by the first support part 26.

[0076] As a result, similar to the accommodation step (step S3 in FIG. 6) in the above-described transfer method, the base end support portion 34 (see FIG. 2) of the first support portion 26 is drawn in the base end direction from the tip opening 80 of the outer cylinder 22. At this time, the base end support portion 34 is drawn into the outer cylinder 22 while curling up. Also, the first support portion 26 is accommodated in the outer cylinder 22 while curling up into a cone shape such that the tip side has a large diameter and the base end support portion 34 has a small diameter.

[0077] When the base end support portion 34 of the first support portion 26 is deformed, the intermediate support portion 36 (see FIG. 2) is drawn into the outer tube 22 while curling, and is deformed into a cylindrical shape along the inner surface of the outer tube 22. Each of the two side portions is curved so that the front surface 461 of the first support portion 26 is on the inside and the back surface 462 of the first support portion 26 is on the outside. Therefore, as in FIG. 9, the back surfaces 462 on both sides of the width direction of the first support portion 26 face each other across the imaginary line L2 extending in a direction perpendicular to the central axis of the outer tube 22. As a result, the first support portion 26 is curved into a heart shape along the inner surface of the outer tube 22. A pair of separation portions 39 are formed in the first support portion 26 based on the two side portions where the back surfaces 462 face each other.

[0078] As the first support portion 26 is curved, the second support portion 50 (see FIGS. 1 to 3) is also curved along the first support portion 26 on the inner side of the first support portion 26 (on the surface 461 side).

[0079] Next, a packaging step (step S15 in FIG. 14) is performed. Here, following the accommodation step, the transport device 10 is in a state in which the first shaft 24 and the second shaft 48 are located at the first position and the first support part 26 and the second support part 50 are accommodated in the outer tube 22. The transport device 10 in this state is packaged in a packaging material 502 shown in FIG.

[0080] Next, a shape imparting step (step S20 in FIG. 14) is performed. In this case, in the shape imparting step, a sterilization treatment is applied to the transfer instrument 10. That is, in this embodiment, the shape imparting step is a sterilization treatment step (step S20' in FIG. 14).

[0081] Specifically, a sterilization process is performed on the transport device 10 in a state in which the first shaft 24 and the second shaft 48 are located at the first position and the first support portion 26 and the second support portion 50 are housed in the outer cylinder 22. The sterilization process increases the temperature of the transport device 10 including the first shaft 24, the first support portion 26, the second shaft 48, the second support portion 50 and the outer cylinder 22. This temperature increase causes the pair of spaced portions 39 housed in the outer cylinder 22 to be shaped, thereby forming the pair of protruding portions 38. The protruding portions 38 are stable in the shape at the time of shaping.

[0082] Sterilization techniques include steam sterilization, radiation sterilization, ethylene oxide gas (EOG) sterilization, and hydrogen peroxide sterilization, with radiation sterilization being particularly preferred. In the case of radiation sterilization, a change occurs in the molecular structure of the first support part 26 as radiation is irradiated. Based on this change, the shape of the protrusion 38 becomes more stable after sterilization. The radiation irradiated to the transfer tool 10 in radiation sterilization may be either an electron beam or a gamma ray.

[0083] As described above, a medical device package 500 is formed, which includes the sterilized transfer device 10 and the packaging material 502 that packages the transfer device 10. Typically, the medical device package 500 is packaged in a packaging material (outer packaging) not shown.

[0084] In the unopened state before the packaging material 502 is opened, the transfer instrument 10 that has been subjected to a sterilization process is in a state in which the first shaft 24 and the second shaft 48 are located at the first position, and the first support part 26 and the second support part 50 are housed in the outer tube 22. The first support part 26 is curved and deformed such that the pair of protruding parts 38 are separated from the inner circumferential surface of the outer tube 22 to form a pair of separated parts 39 that protrude into the inside of the outer tube 22.

[0085] The packaging material 502 is opened, for example, in an operating room, etc. After being removed from the packaging material 502, the transfer device 10 is used to transfer the medical sheet 300 (see FIG. 1) as described above.

[0086] In the embodiment shown in Fig. 14, in the shaping step, the shaping of the pair of spaced portions 39 and the sterilization treatment of the transferring device 10 are performed simultaneously. In contrast, as shown in Fig. 16, the shaping of the pair of spaced portions 39 and the sterilization treatment of the transferring device 10 may be performed as separate steps. Hereinafter, a method for manufacturing the transferring device 10 in this embodiment will be described.

[0087] The manufacturing method of this embodiment includes a containing step (step S10), a shaping step (step S12), a packaging step (step S15), and a sterilization step (step S20') as shown in Fig. 16. Note that the containing step, packaging step, and sterilization step can be performed in the same manner as described above, and therefore detailed explanations will be omitted.

[0088] In an accommodation step (step S10 in FIG. 16), the first support portion 26 is accommodated in the outer cylinder 22 in the state shown in FIG. 9. Next, in a shaping step (step S12 in FIG. 16), a heating process is performed in which the temperature of the transferring device 10 is increased. Based on this heating process, the pair of spaced portions 39 are shaped.

[0089] In the temperature increase process, the temperature of the transfer device 10 may be increased to a temperature at which the pair of spaced portions 39 are shaped. One example of a method for increasing the temperature of the transfer device 10 is the above-mentioned method for performing the sterilization process. For the reasons described above, it is preferable to irradiate the transfer device 10 with radiation such as electron beams or gamma rays. However, the temperature reached by the transfer device 10 may be lower than the temperature reached by the transfer device 10 in the sterilization process. Alternatively, the temperature reached by the transfer device 10 may be higher than the temperature reached by the transfer device 10 in the sterilization process.

[0090] This shaping step shapes the pair of spaced portions 39 housed within the outer cylinder 22, forming the pair of protruding portions 38. The protruding portions 38 are stable in the shape they have when shaping is performed.

[0091] Next, a packaging step (step S15 in FIG. 16) is performed. The transfer device 10 is sealed in a packaging material 502, for example.

[0092] Next, a sterilization process (step S20′ in FIG. 16) is performed to sterilize the transfer device 10. A specific example of the sterilization process is the sterilization method presented in the shaping process (step S20) shown in FIG.

[0093] In addition, the packaging step may be performed before the shaping step. In the manufacturing method of this embodiment, the containing step, packaging step, shaping step, and sterilization step are performed in this order.

[0094] As described above, a medical device package 500 is formed, which includes the sterilized transfer device 10 and the packaging material 502 that packages the transfer device 10. Typically, the medical device package 500 is packaged in a packaging material (outer packaging) not shown.

[0095] This embodiment provides the following advantages.

[0096] The transfer device 10 includes an outer tube 22 having a distal end opening 80, and a first carrier member 18. Here, the first carrier member 18 includes a first shaft 24 extending in the axial direction of the outer tube 22 and disposed inside the outer tube 22 so as to be movable along the axial direction, and a sheet-like first support part 26 disposed at the distal end of the first shaft 24. The first support part 26 includes a first support surface 261 capable of holding the medical sheet 300, a front surface 461 including the first support surface 261, and a back surface 462 opposite the front surface 461. The width of the first support part 26 in the direction perpendicular to the extension direction of the first shaft 24 is greater than the inner circumferential length of the outer tube 22.

[0097] The first support portion 26 has a support base portion 264 having a first support surface 261, and a pair of protrusions 38 protruding upward from both sides of the support base portion 264 in the width direction of the first support portion 26. At a first position where the first shaft 24 is moved in the proximal direction relative to the outer tube 22 so that the first support portion 26 is accommodated in the outer tube 22, the first support portion 26 is accommodated in the outer tube 22 in a curved and deformed state. On the other hand, at a second position where the first shaft 24 is moved in the distal direction relative to the outer tube 22 so that the first support portion 26 protrudes from a distal opening 80 of the outer tube 22, the first support portion 26 is exposed in the distal direction from the outer tube 22 and deployed.

[0098] A manufacturing method for obtaining such a transfer device 10 includes an accommodation step (step S10 in FIG. 14 or FIG. 16) and a shaping step (step S20 in FIG. 14 or step S12 in FIG. 16). The accommodation step is a step of accommodating the first support part 26 in the outer tube 22 by moving the first shaft 24 from the second position to the first position in a state in which the first support part 26 is curved and deformed so that both side parts face each other at the back surface 462. In the first support part 26 accommodated in the outer tube 22, the opposing both side parts form a pair of separated parts 39 that are separated from the inner circumferential surface of the outer tube 22 and protrude into the inside of the outer tube 22. The shaping process is a process in which, with the first support portion 26 forming a pair of spaced portions 39 within the outer tube 22, the outer tube 22, the first shaft 24, and the first support portion 26 are subjected to a heating process that increases the temperature of the outer tube 22, the first shaft 24, and the first support portion 26, thereby shaping a pair of protrusions 38.

[0099] According to this manufacturing method, the pair of protrusions 38 are stabilized in the shape formed in the shaping step. Therefore, when the medical sheet 300 is transported, the protrusions 38 are smoothly accommodated in the outer tube 22 (lumen 78) by moving the first shaft 24 from the second position to the first position. This allows the transport instrument 10 to be made thinner and less invasive.

[0100] In one embodiment, in the shape-imparting step, a sterilization process is performed on the transfer device 10. That is, in this embodiment, the shape-imparting step also serves as a sterilization process (step S20' in FIG. 14).

[0101] In this case, the pair of protrusions 38 can be shaped simultaneously with the sterilization process, which allows the transfer device 10 to be manufactured efficiently.

[0102] The sterilization treatment is preferably radiation sterilization, in which case the shape of the pair of protrusions 38 becomes more stable when shaped.

[0103] In a typical example, the accommodating step causes at least a part of the portions of the pair of spaced portions 39 that face each other to come into contact with each other.

[0104] The medical device package 500 includes the above-mentioned transfer instrument 10 that has been subjected to a sterilization treatment, and a packaging material 502 in which the transfer instrument 10 is packaged. Here, in an unopened state before the packaging material 502 is opened, the outer tube 22, the first shaft 24, and the first support part 26 are accommodated in the outer tube 22 with the first shaft 24 located at the first position and the first support part 26 curved and deformed so that the pair of protruding parts 38 are separated from the inner peripheral surface of the outer tube 22 to form a pair of separated parts 39 that protrude into the inside of the outer tube 22.

[0105] The first support portion 26 has a pair of protruding portions 38 that are shaped during the sterilization process. In this case, the shape of the pair of protruding portions 38 is stable in the shape that is shaped during the sterilization process.

[0106] Furthermore, if the first support parts 26 are kept housed within the outer tube 22 prior to using the transport device 10, the shape of the pair of protrusions 38 becomes even more stable. Therefore, when transporting the medical sheet 300 using the transport device 10 removed from the packaging material 502, the first shaft 24 is moved from the second position to the first position, whereby the protrusions 38 are smoothly housed within the outer tube 22. This allows the transport device 10 to be made thinner and less invasive.

[0107] The sterilization method applied to the transfer instrument 10 includes an accommodation step (step S10 in FIG. 14) and a sterilization treatment step (step S20' in FIG. 14). The accommodation step is a step of accommodating the first support part 26 in the outer tube 22 by moving the first shaft 24 from the second position to the first position in a state in which the first support part 26 is curved and deformed so that both side parts face each other at the back surface 462. In the first support part 26 accommodated in the outer tube 22, the opposing both side parts form a pair of separated parts 39 that are separated from the inner circumferential surface of the outer tube 22 and protrude into the inside of the outer tube 22. The sterilization process is a process in which, with the first support portion 26 forming a pair of spaced portions 39 within the outer tube 22, the outer tube 22, the first shaft 24 and the first support portion 26 are subjected to a heating process which increases the temperatures of the outer tube 22, the first shaft 24 and the first support portion 26, thereby sterilizing the transfer device 10 and shaping the pair of protrusions 38.

[0108] For the reasons stated above, this sterilization method allows the transfer device 10 to be made thinner and less invasive, and allows the transfer device 10 to be manufactured efficiently.

[0109] When a packaging step (step S15 in FIG. 14) of packaging the transportation instrument 10 in the packaging material 502 is performed, the sterilization step is performed after the packaging step. In this case, the transportation instrument 10 packaged in the packaging material 502 is sterilized, so that the transportation instrument 10 remains packaged in the packaging material 502 before and after the sterilization step. This allows the transportation instrument 10 to be kept clean.

[0110] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention. [Explanation of symbols]

[0111] 10...Transportation device 18...First carrier member 22: Outer cylinder 24: First shaft 26...First support part 38...Protrusion part 39...Separation part 261...First support surface 300... Medical sheet 402... Transplant target part 500... Medical device packaging 502... Packaging materials

Claims

1. A method for manufacturing a transfer device for transferring a medical sheet to a treatment target part of a living body, comprising the steps of: The transfer device includes: An outer cylinder having a tip opening; a carrier member having a shaft extending in an axial direction of the outer cylinder and disposed inside the outer cylinder so as to be movable along the axial direction, and a sheet-shaped support portion disposed at a tip portion of the shaft; the support portion has a support surface capable of holding the medical sheet, a front surface including the support surface, and a back surface opposite to the front surface, and a width of the support portion in a direction perpendicular to an extension direction of the shaft is greater than an inner peripheral length of the outer tube, The support portion includes a support base portion having the support surface, and a pair of protrusions protruding upward from both sides of the support base portion in a width direction of the support portion, At a first position where the shaft is moved in a proximal direction relative to the outer tube so that the support portion is housed within the outer tube, the support portion is housed within the outer tube in a curved and deformed state, and at a second position where the shaft is moved in a distal direction relative to the outer tube so that the support portion protrudes from the distal opening of the outer tube, the support portion is exposed in a distal direction from the outer tube and deployed, The manufacturing method includes: an accommodating process for accommodating the support portion within the outer tube by bending and deforming the support portion so that both widthwise ends of the support portion face each other on the back surface, and moving the shaft from the second position to the first position so that the opposing both ends form a pair of spaced portions that are spaced from an inner peripheral surface of the outer tube and protrude into the inside of the outer tube; a shaping process for shaping the pair of protrusions by subjecting the outer cylinder, the shaft, and the support portion to a heating process that increases the temperatures of the outer cylinder, the shaft, and the support portion in a state in which the support portion forms the pair of spaced portions within the outer cylinder; A method for manufacturing a transfer device having the following structure:

2. 2. The method for producing a transfer device according to claim 1, wherein the temperature increase treatment in the shaping step is a sterilization treatment.

3. 3. The method of claim 2, wherein the sterilization treatment is radiation sterilization.

4. 4. The method for manufacturing a transfer device according to claim 1, wherein in the accommodating step, at least a part of the portions of the pair of spaced apart parts that face each other is brought into contact with each other.

5. A medical device package comprising a transfer device for transferring a medical sheet to a treatment target part of a living body, and a packaging material for packaging the transfer device, The transfer device includes: An outer cylinder having a tip opening; a carrier member having a shaft extending in an axial direction of the outer cylinder and disposed inside the outer cylinder so as to be movable along the axial direction, and a sheet-shaped support portion disposed at a tip portion of the shaft; the support portion has a support surface capable of holding the medical sheet, a front surface including the support surface, and a back surface opposite to the front surface, and a width of the support portion in a direction perpendicular to an extension direction of the shaft is greater than an inner peripheral length of the outer tube, The support portion includes a support base portion having the support surface, and a pair of protrusions protruding upward from both sides of the support base portion in a width direction of the support portion, At a first position where the shaft is moved in a proximal direction relative to the outer tube so that the support portion is housed within the outer tube, the support portion is housed within the outer tube in a curved and deformed state, and at a second position where the shaft is moved in a distal direction relative to the outer tube so that the support portion protrudes from the distal opening of the outer tube, the support portion is exposed in a distal direction from the outer tube and deployed, A medical device package in which the outer tube, shaft and support part which have been sterilized are contained in the packaging material, and in an unopened state prior to opening the packaging material, the shaft is located at the first position, and the support part is curved and deformed to be contained within the outer tube so that the pair of protrusions are spaced apart from the inner surface of the outer tube to form a pair of spaced apart parts which protrude into the inside of the outer tube.

6. A method for sterilizing a transfer device for transferring a medical sheet to a treatment target part of a living body, comprising the steps of: The transfer device includes: An outer cylinder having a tip opening; a carrier member having a shaft extending in an axial direction of the outer cylinder and disposed inside the outer cylinder so as to be movable along the axial direction, and a sheet-shaped support portion disposed at a tip portion of the shaft; the support portion has a support surface capable of holding the medical sheet, a front surface including the support surface, and a back surface opposite to the front surface, and a width of the support portion in a direction perpendicular to an extension direction of the shaft is greater than an inner peripheral length of the outer tube, The support portion includes a support base portion having the support surface, and a pair of protrusions protruding upward from both sides of the support base portion in a width direction of the support portion, At a first position where the shaft is moved in a proximal direction relative to the outer tube so that the support portion is housed within the outer tube, the support portion is housed within the outer tube in a curved and deformed state, and at a second position where the shaft is moved in a distal direction relative to the outer tube so that the support portion protrudes from the distal opening of the outer tube, the support portion is exposed in a distal direction from the outer tube and deployed, The sterilization method includes: an accommodating process for accommodating the support portion within the outer tube by bending and deforming the support portion so that both widthwise ends of the support portion face each other on the back surface, and moving the shaft from the second position to the first position so that the opposing both ends form a pair of spaced portions that are spaced from an inner peripheral surface of the outer tube and protrude into the inside of the outer tube; a sterilization process for performing a sterilization process involving an increase in temperature of the outer tube, the shaft, and the support part while the support part has formed the pair of spaced parts within the outer tube, and shaping the pair of protrusions based on the increase in temperature; A method for sterilizing a transfer device comprising:

7. 7. The method for sterilizing a transfer device according to claim 6, further comprising a packaging step of packaging the transfer device in a packaging material, and the sterilization step is carried out after the packaging step.

Images