Transfer device

Abstract

To provide a transfer device for transferring a tubular transplant having an inner cavity to a treatment target part in a lumen of a living body.SOLUTION: A transfer device 10 includes: a second shaft 48 provided so as to be movable along a first shaft 22 in the inside of an outer cylinder 20; and an expansion body 52 provided in a distal end portion of the second shaft 48. At a projection position at which the expansion body 52 projects from a distal end opening 202 of the outer cylinder 20, when the expansion body 52 inserted to an inner cavity 302 of a tubular transplant 300 is expanded, the tubular transplant 300 is expanded in the lumen of the patient.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a transfer device for transferring a tubular graft to a treatment target part of a living body.

Background Art

[0002] Patent Document 1 discloses, for example, a transfer device for transferring a tubular stent graft (tubular graft) into a lumen of a living body. The transfer device includes a stent graft, a sheath capable of accommodating the stent graft in the lumen of the living body, and a delivery device that delivers the self-expanding type stent graft that can be expanded by its own elastic force into the lumen.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] It is desired to efficiently transfer a non-self-expanding type tubular graft to a treatment target part of a living body.

Means for Solving the Problems

[0005] (1) Aspect of the present invention is a transfer device for transferring a tubular graft having a lumen to a treatment target site in a living body lumen, comprising an outer cylinder having a tip opening, a first shaft extending in the axial direction of the outer cylinder and axially movably disposed inside the outer cylinder, a second shaft extending along the first shaft within the outer cylinder and movably provided along the first shaft, and an expandable body provided at the tip of the second shaft and displaceable between a housed position housed in the outer cylinder and a protruding position protruding from the tip opening of the outer cylinder, and capable of expanding and contracting. The outer cylinder is capable of housing the tubular graft and the expandable body with the expandable body inserted into the lumen of the tubular graft in a contracted state, and by expanding the expandable body inserted into the lumen of the tubular graft with the expandable body positioned at the protruding position, the tubular graft can be expanded. The transfer device is as described above.

[0006] According to this transfer device, the tubular graft can be efficiently housed in the outer cylinder in a state where the tubular graft is smaller than the outer cylinder. In the living body lumen, by protruding the expandable body from the inside of the outer cylinder and expanding the expandable body, a non-self-expanding tubular graft can be efficiently placed at the treatment target site in the lumen.

[0007] (2) In the transfer device according to (1) above, the tip of the first shaft is provided with a support portion capable of holding the tubular graft and expanding by protruding in the tip direction from the tip opening of the outer cylinder. The support portion may have a support surface on which the tubular graft can be placed.

[0008] With this configuration, by placing the tubular graft on the support surface, it is easy to hold the tubular graft against the support portion.

[0009] (3) In the transfer device according to (1) above, the tip of the first shaft is provided with a support portion capable of holding the tubular graft and expanding by protruding in the tip direction from the tip opening of the outer cylinder. The support portion may be inserted into the lumen of the tubular graft.

[0010] With this configuration, since the tubular graft can be held so as to cover around the support portion, the tubular graft can be held more effectively.

[0011] (4) In the transfer device according to (2) or (3) above, a proximal end portion of the expandable body is connected to the distal end portion of the second shaft, and the distal end portion of the second shaft or the proximal end portion of the expandable body may have a pressing portion that presses the tubular graft in the distal end direction. With this configuration, in a state where the support portion is deployed, by moving the second shaft in the distal end direction, the tubular graft can be effectively transferred toward the treatment target portion by the pressing portion.

[0012] (5) In the transfer device according to (2) or (3) above, the distal end portion of the first shaft may have a pressing portion that presses the tubular graft in the distal end direction. With this configuration, by moving the first shaft in the distal end direction, the tubular graft can be effectively transferred toward the treatment target portion by the pressing portion.

[0013] (6) In the transfer device according to any one of (2) to (5) above, the support portion may have a holding portion that holds the tubular graft on the support surface. With this configuration, the tubular graft can be held on the support surface of the support portion more effectively by the holding portion.

[0014] (7) In the transfer device according to (6) above, the holding portion may have a holding piece provided at a proximal end portion of the support portion and extending from the proximal end portion toward the distal end direction and facing the support surface.

[0015] With this configuration, since the tubular graft can be held on the proximal end portion side of the support portion by the holding piece, the holding portion does not become an obstacle when the tubular graft is moved in the distal end direction.

[0016] (8) In the transfer device according to (6) above, the support portion has a pair of protruding portions protruding upward from both side portions in the width direction of the support surface orthogonal to the moving direction of the first shaft, and the protruding portion may be the holding portion.

[0017] With this configuration, by using a pair of protruding portions for bending and deforming and accommodating the tubular graft, the tubular graft can be effectively held on the support surface of the support portion.

Effects of the Invention

[0018] According to the present invention, since the outer cylinder can accommodate the tubular graft and the expander in a state where the expander is inserted into the lumen of the tubular graft in a contracted state, the tubular graft can be efficiently accommodated in the outer cylinder in a state where the tubular graft is smaller than the outer cylinder. In a state where the expander is positioned at the protruding position, the tubular graft can be expanded by expanding the expander inserted into the lumen of the tubular graft. Thereby, by expanding the expander in the lumen of the living body, a non-self-expandable tubular graft can be efficiently arranged at the treatment target portion in the lumen.

Brief Description of the Drawings

[0019]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Embodiments for Carrying Out the Invention

[0020] As shown in FIG. 1, the transfer device 10 according to the present embodiment is a medical device for transferring a non-self-expanding tubular graft 300 into a body lumen 400. In this case, the tubular graft 300 is, for example, an artificial blood vessel, a matrix containing a therapeutic substance, gelatin, etc., and is transplanted into a blood vessel, digestive tract, etc. (a treatment target part of the living body) that is a lumen in the living body (see FIGS. 12 to 18).

[0021] The tubular graft 300 is substantially cylindrical and extends in the axial direction in a radially outwardly expanded state (see FIG. 9). The tubular graft 300 has a lumen 302 that penetrates in the axial direction. However, the thickness and diameter (size) of the tubular graft 300 can be set as appropriate. Note that the lumen 302 of the tubular graft 300 is not limited to penetrating both axial ends of the tubular graft 300. For example, a tubular graft 300 with one axial end blocked may be used. This tubular graft 300 is used, for example, in the treatment of closing the left atrial appendage in the left atrium of the heart.

[0022] The transfer device 10 includes an instrument body 12 and an endoscope 14. The instrument body 12 includes a carrier member 16, an expansion member 18, and an outer cylinder 20. Note that the transfer device 10 is not limited to including an endoscope 14. As shown in FIG. 2, the carrier member 16 has a first shaft 22 and a support portion 24.

[0023] The first shaft 22 is a tubular body (a circular tube member in the present embodiment) having a first lumen 221. The first lumen 221 opens at the tip (the end in the direction of arrow X1) of the first shaft 22 and also opens at the base end (the end in the direction of arrow X2) of the first shaft 22. An airtight valve body 26 that adheres to the outer peripheral surface of the second shaft 48 is provided at the base end of the first shaft 22. A marker 261 is provided on the outer peripheral surface of the valve body 26. When using the transfer device 10, the user can visually recognize the marker 261. Note that the first shaft 22 is not limited to a tubular body and may not be a tubular body.

[0024] The first shaft 22 extends in the axial direction of the outer cylinder 20 and is disposed inside the outer cylinder 20 so as to be axially movable along the inner part of the outer cylinder 20. The first shaft 22 is made of, for example, a resin material. The constituent material of the first shaft 22 is not particularly limited, and examples thereof include polyethylene, polypropylene, fluororesin, polyethylene terephthalate, polymethyl methacrylate, polyamide resin, polystyrene, polycarbonate, polyimide, polyetherimide, polyetheretherketone, polyvinyl chloride, ABS resin, polyamide elastomer, polyester elastomer, and the like. The first shaft 22 may be made of a metal material.

[0025] The first shaft 22 may have flexibility. The first shaft 22 may have a flexible tube portion capable of holding a bent shape. In this case, within the lumen 400 of the living body, the first shaft 22 can be bent into an appropriate shape and the bent shape can be maintained.

[0026] As shown in FIG. 3, the support portion 24 is attached to the tip of the first shaft 22. The support portion 24 is made of, for example, a resin material. The support portion 24 can hold the tubular graft 300 (see FIG. 8). When the tubular graft 300 is held by the support portion 24, for example, the tubular graft 300 is made into a substantially flat shape by being pushed radially inward from the outer peripheral surface of the tubular graft 300 (see FIG. 1). The support portion 24 is formed by bending a resin sheet material (film material) having flexibility into a predetermined shape. The support portion 24 is formed, for example, by forming the sheet material into a predetermined shape using a sheet molding die. The thickness of the sheet material is not particularly limited, but is preferably set, for example, to be 100 μm or more and 200 μm or less. The support portion 24 has a joint portion 28 and a support body 32.

[0027] The constituent material of the support portion 24 is not particularly limited, but it is preferably transparent, and examples thereof include polyethylene, polycarbonate, polyamide, polystyrene, polypropylene, polyacetal resin, polyimide, polyetherimide, polyetheretherketone, polyethylene terephthalate, fluororesin, etc. Further, the support portion 24 may be in a mesh shape.

[0028] In FIG. 4, the joint portion 28 is adhered to the inner peripheral surface of the tip of the first shaft 22 by an adhesive. The adhesive is not particularly limited, and examples thereof include UV adhesives, hot melt adhesives, instant adhesives (e.g., cyanoacrylate-based instant adhesives), etc. The joint portion 28 may be heat-sealed to the inner peripheral surface of the first shaft 22. Note that the support portion 24 may be detachable from the tip of the first shaft 22.

[0029] As shown in FIG. 2, the support body 32 extends in the tip direction from the joint portion 28. The support body 32 has a base end support portion 34, an intermediate support portion 36, a pair of first protrusions 38, a pair of second protrusions 40, and a tip support portion 42. The support body 32 has a support surface 241. The marker 261 of the first shaft 22 is arranged so that when the support surface 241 faces upward, the marker 261 faces upward. That is, the user can confirm the direction of the support surface 241 in the support portion 24 by the marker 261. The support surface 241 can place the tubular graft 300.

[0030] As shown in FIG. 3, the base end support portion 34 is formed to be wide in its extending direction. In other words, both side portions in the width direction of the base end support portion 34 are inclined in a tapered shape toward the joint portion 28. The intermediate support portion 36 is formed in a tapered shape whose width gradually decreases from the tip toward the base end direction (arrow X2 direction).

[0031] The tip support portion 42 is connected to the tip of the intermediate support portion 36 and the tips of the pair of second protruding portions 40. The tip support portion 42 protrudes in an arc shape toward the tip direction (arrow X1 direction). That is, when viewed from a direction orthogonal to the support surface 241 shown in FIG. 3, the tip support portion 42 of the support portion 24 is in an arc shape connecting the pair of second protruding portions 40.

[0032] As shown in FIG. 4, the base end support portion 34 extends from the tip of the joint portion 28 in the tip direction (arrow X1 direction) substantially along the axis Ax of the first shaft 22. The intermediate support portion 36 intersects the axis Ax of the first shaft 22 from the tip of the base end support portion 34 in the tip direction (arrow X1 direction) and extends in the tip direction (arrow X1 direction) of the support portion 24.

[0033] As shown in FIG. 3, the pair of first protruding portions 38 protrude upward (arrow Y direction) and inward in the width direction of the intermediate support portion 36 from both side portions in the width direction of the intermediate support portion 36 orthogonal to the moving direction of the first shaft 22. The pair of first protruding portions 38 are connected to the base end support portion 34. The first protruding portion 38 is in an arc shape bulging convexly in a direction away from the support surface 241.

[0034] The pair of second protruding portions 40 are respectively connected to the tips of the pair of first protruding portions 38. The pair of second protruding portions 40 protrude upward and outward in the width direction of the intermediate support portion 36 from both side portions in the width direction (arrow W direction) of the intermediate support portion 36. The second protruding portion 40 is formed with a smaller curvature than the first protruding portion 38. The second protruding portion 40 has a lower protruding height with respect to the support surface 241 than the first protruding portion 38 (see FIG. 2).

[0035] Each of the pair of first protruding portions 38 has a pair of bent portions 44. Each of the pair of bent portions 44 bends the pair of first protruding portions 38 with respect to the support surface 241 (intermediate support portion 36) of the support portion 24 (see FIG. 5).

[0036] As shown in FIG. 5, the support body 32 has a surface 461 facing upward (in the direction of arrow Y) and including the support surface 241, and a back surface 462 opposite to the surface 461. The support surface 241 is a flat surface continuous with the upper surfaces of the base-end support portion 34, the intermediate support portion 36, and the tip-end support portion 42.

[0037] As shown in FIG. 2, the expansion member 18 has a second shaft 48, an expansion body 52, and a hub 54.

[0038] The second shaft 48 is a tubular body (a circular tube member in this embodiment) having a second inner cavity 481 (see FIG. 4). The second shaft 48 extends along the first shaft 22 within the outer cylinder 20 and is provided so as to be movable along the first shaft 22.

[0039] An expansion fluid S (see FIG. 16) capable of expanding the expansion body 52 is introduced into the second inner cavity 481. The length of the second shaft 48 along the axial direction is longer than the length of the first shaft 22 along the axial direction. The second shaft 48 is inserted into the first inner cavity 221 of the first shaft 22 (see FIG. 4). In other words, the tip end portion of the second shaft 48 protrudes in the tip end direction (arrow X1 direction) from the tip end opening of the first shaft 22. The base end portion of the second shaft 48 protrudes in the base end direction (arrow X2 direction) from the base end opening of the first shaft 22 (see FIG. 1). The second shaft 48 extends along the first shaft 22 and is provided so as to be movable along the first shaft 22.

[0040] The second shaft 48 is configured to be able to follow the shape of the support portion 24. As the constituent material of the second shaft 48, for example, a material having higher flexibility than the constituent material of the first shaft 22 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 has flexibility.

[0041] As shown in FIG. 3, the expander 52 is provided at the tip of the second shaft 48 so as to be expandable and contractible. The expander 52 is displaceable between a housed position (see FIG. 10) housed in the outer cylinder 20 and a protruding position (see FIG. 3) protruding from the tip opening 202 of the outer cylinder 20. The expander 52 is a balloon that expands by supplying expansion fluid S therein (see FIG. 16). The expander 52 includes a cylindrical body portion 521, a first end portion 522 provided at the tip of the body portion 521, and a second end portion 523 provided at the base end of the body portion 521. The body portion 521 is expandable radially outward. The second end portion 523 is connected to the tip of the second shaft 48. The interior of the expander 52 communicates with the second inner cavity 481 of the second shaft 48.

[0042] The base end portion of the expander 52 has a pressing portion 50 that presses the tubular graft 300 placed on the support portion 24 in the tip direction. As shown in FIG. 4, the pressing portion 50 is provided at the tip of the second end portion 523. The pressing portion 50 protrudes radially outward from the outer peripheral surface of the second end portion 523 (see FIG. 5). The pressing portion 50 is provided at at least a part in the circumferential direction of the second end portion 523. Note that the pressing portion 50 is not limited to being provided at the tip of the second end portion 523. For example, it may be arranged in the base end direction with respect to the tip of the second end portion 523. Also, the pressing portion 50 is not limited to being provided at the base end portion of the expander 52. For example, the pressing portion 50 may be provided at the tip of the second shaft 48. Further, the pressing portion 50 may be formed in an annular shape along the outer peripheral surface of the second end portion 523. The outer diameter of the pressing portion 50 may be larger than the inner diameter of the first shaft 22. According to this configuration, when the second shaft 48 is pulled in the base end direction, the pressing portion 50 hits the tip of the first shaft 22, thereby preventing the second shaft 48 from being pulled out in the base end direction with respect to the first shaft 22.

[0043] The expandable body 52 is made of a resin material that can expand and contract. The constituent material of the expandable body 52 is not particularly limited, and examples include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, chloroprene rubber, nitrile rubber, butyl rubber, ethylene-propylene-diene rubber, acrylic rubber, fluororubber, urethane rubber, silicone rubber, styrene-based elastomer, olefin-based elastomer, polyester-based elastomer, polyurethane-based elastomer, polyamide-based elastomer, and the like. Note that the expandable body 52 may be formed of a non-stretchable material.

[0044] As shown in FIG. 2, the hub 54 is attached to the proximal end portion of the second shaft 48. The proximal end of the hub 54 is provided with a port 541 to which the expanding fluid S is supplied. The port 541 communicates with the second inner cavity 481 of the second shaft 48. The expanding fluid S supplied to the port 541 is supplied into the expandable body 52 through the second inner cavity 481.

[0045] The outer cylinder 20 is a cylindrical member having an inner cavity 201. As shown in FIG. 9, the diameter of the inner cavity 201 in the outer cylinder 20 is smaller than the diameter of the tubular graft 300. As shown in FIG. 2, the inner cavity 201 has a tip opening 202 that opens at the tip of the outer cylinder 20 (the end in the direction of arrow X1). The inner cavity 201 opens at the proximal end of the outer cylinder 20 (the end in the direction of arrow X2). The outer cylinder 20 has flexibility. Examples of the constituent material of the outer cylinder 20 include the same materials as those of the first shaft 22 described above.

[0046] As shown in FIG. 4, the first shaft 22 is inserted into the inner cavity 201 of the outer cylinder 20. The length of the outer cylinder 20 along the axial direction is shorter than the length of the first shaft 22 along the axial direction. As shown in FIG. 2, an airtight valve body 56 that is in close contact with the outer peripheral surface of the first shaft 22 is provided at the proximal end of the outer cylinder 20. The distal end surface of the outer cylinder 20 extends along a direction perpendicular to the axial direction of the outer cylinder 20.

[0047] The endoscope 14 has a long endoscope body 58. The distal end portion of the endoscope body 58 is fixed to the outer peripheral surface of the outer cylinder 20 by a fixing member 60 (see FIG. 1). The objective lens 62 provided on the distal end surface of the endoscope body 58 faces the distal end direction of the outer cylinder 20 (arrow X1 direction). The distal end portion of the endoscope body 58 is fixed to the intermediate portion in the axial direction of the outer cylinder 20. However, the distal end portion of the endoscope body 58 may be fixed to the distal end portion of the outer cylinder 20.

[0048] The fixing member 60 includes, for example, a fixing cylinder 64 and a fixing tube 66. The endoscope body 58 can be inserted into the fixing cylinder 64. The fixing cylinder 64 is arranged along the longitudinal direction of the outer cylinder 20. The fixing tube 66 is a tube for fixing the fixing cylinder 64 to a predetermined position of the outer cylinder 20. The fixing tube 66 is, for example, a heat-shrinkable tube. Note that the method of fixing the distal end portion of the endoscope body 58 to the outer cylinder 20 can be set as appropriate.

[0049] Next, a transfer method for transferring the tubular graft 300 to the treatment target portion in the body lumen 400 will be described. Specifically, as shown in FIGS. 12 to 18, a transfer method for transferring the tubular graft 300 to the graft target portion 402 (the treatment target portion of the living body) in the lumen 400 through the mouth P1 of the patient P will be described. The body lumen 400 is, for example, the digestive tract (esophagus, stomach, small intestine, large intestine). When transferring the tubular graft 300 to the digestive tract as the lumen 400, for example, the tubular graft 300 may be transferred through the anus instead of the mouth P1. As shown in FIG. 6, the transfer method according to the present embodiment includes a preparation step, a placement step, a housing step, an arrangement step, a deployment step, a movement step, an expansion step, and a removal step.

[0050] First, in the preparation step (step S1 in FIG. 6), the transfer device 10 according to the above-described embodiment is prepared. Hereinafter, the state as shown in FIG. 1 will be described as the initial state of the transfer device 10. In the initial state, the first and second shafts 22 and 48 are moved in the distal direction (arrow X1 direction) with respect to the outer cylinder 20, and the support portion 24 protrudes in the distal direction from the distal opening 202 of the outer cylinder 20 to a protruding position. The support portion 24 is deployed by being exposed in the distal direction from the outer cylinder 20, and the support surface 241 of the support portion 24 is arranged to face upward. At this time, as shown in FIG. 7, the endoscope 14 is removed from the outer cylinder 20.

[0051] Subsequently, in the placement step (step S2 in FIG. 6), as shown in FIGS. 7 and 8, the tubular graft 300 is placed on the support surface 241 of the support portion 24. Specifically, as shown in FIG. 9, by pressing the substantially cylindrical tubular graft 300 inward in the radial direction, the inner peripheral surfaces of the tubular graft 300 are radially crushed so as to approach each other to make the tubular graft 300 into a substantially flat shape, and then the expander 52 is inserted into the lumen 302 of the tubular graft 300. For example, the body portion 521 of the expander 52 is inserted substantially at the center in the width direction of the tubular graft 300. The tubular graft 300 into which the expander 52 is inserted is placed on the support surface 241 of the support portion 24. The support portion 24 and the tubular graft 300 are in a substantially parallel state. The substantially flat tubular graft 300 has a pair of corner portions 304 spaced apart in the width direction. The pair of corner portions 304 are arranged to face upward, and each corner portion 304 is placed so as to be close to the pair of first protruding portions 38 of the support portion 24.

[0052] Thereafter, an accommodation step (step S3 in FIG. 6) of accommodating the tubular graft 300 in the outer cylinder 20 is performed. The tubular graft 300 is set to an accommodation position where it is accommodated in the outer cylinder 20 together with the support portion 24. Specifically, the first shaft 22 of the carrier member 16 and the second shaft 48 of the expansion member 18 are moved together in the proximal direction (arrow X2 direction) with respect to the outer cylinder 20.

[0053] Then, as shown in FIG. 10, the proximal support portion 34 of the support portion 24 is drawn into the inner cavity 201 from the distal opening 202 of the outer cylinder 20 in the proximal direction. At this time, when both tapered side portions of the proximal support portion 34 come into contact with the distal end of the outer cylinder 20, a force acts on the proximal support portion 34 to cause it to round along the circumferential direction of the outer cylinder 20. Therefore, the proximal support portion 34 is smoothly drawn into the outer cylinder 20 while rounding. The support portion 24 is housed in the outer cylinder 20 while rounding in a conical shape such that the distal end side has a larger diameter and the proximal support portion 34 has a smaller diameter.

[0054] When the proximal support portion 34 is deformed, a force acts on the intermediate support portion 36 to cause it to round along the circumferential direction of the outer cylinder 20. Therefore, the intermediate support portion 36 is drawn into the outer cylinder 20 while rounding. At this time, the intermediate support portion 36 deforms into a cylindrical shape along the inner surface of the outer cylinder 20. As shown in FIG. 11, each of the pair of first protrusions 38 is curved such that the fixed end is wound inward, the front surface 461 of the support portion 24 is on the inner side, and the back surface 462 of the support portion 24 is on the outer side. The back surfaces 462 of the intermediate portions that bulge convexly outward in the radial direction come into contact with each other on an imaginary line L extending in a direction orthogonal to the central axis of the outer cylinder 20. The intermediate portion of one first protrusion 38 and the intermediate portion of the other first protrusion 38 come into contact with each other and are accommodated downward (support surface 241, front surface 461).

[0055] As a result, the back surface 462 of the support portion 24 becomes a curved shape that closely adheres to the inner surface of the outer cylinder 20, further curves so as to fold back toward the center of the outer cylinder 20 from the fixed end to the free end of each first protrusion 38, and the pair of free ends are disposed below the central axis of the outer cylinder 20. That is, the support portion 24 curves into a heart shape along the inner surface of the outer cylinder 20.

[0056] The heart shape refers to a substantially circular shape composed of a shape that is convexly curved on one side and a shape that is convexly curved in two places on the other side, which is opposite to the one side. When a heart shape is formed in the inner cavity 201 of the tubular body (outer cylinder 20), two convex curved shapes protruding toward the other side along the inner surface of the tubular body approach each other and a part of the circumferential surface contacts each other, so that the overall contour becomes a substantially circular shape along the inner surface of the tubular body (refer to the shape of the support portion 24 in FIG. 11). Note that it is not limited to the case where the support portion 24 is curved and accommodated in a heart shape within the outer cylinder 20. For example, within the outer cylinder 20, a pair of first protruding portions 38 may be curved and accommodated in a C shape while being separated from each other along the inner circumferential surface of the outer cylinder 20.

[0057] As the support portion 24 is curved and deformed, the substantially flat tubular graft 300 is deformed into a shape corresponding to the shape of the support body 32, and the tubular graft 300 is accommodated within the outer cylinder 20. As shown in FIG. 10, the accommodation process is completed when the entire support portion 24 is completely inserted into the outer cylinder 20.

[0058] In the accommodated state where the support portion 24 and the tubular graft 300 are accommodated within the outer cylinder 20, as shown in FIG. 10, the pair of first protruding portions 38 are positioned in the tip direction (arrow X1 direction) with respect to the pressing portion 50 in a state where the back surfaces 462 are in contact with each other.

[0059] Thereafter, in the placement process (step S4 in FIG. 6), as shown in FIG. 12, the transfer instrument 10 is inserted into the lumen 400 through the mouth P1 of the patient P. At this time, the tip of the transfer instrument 10 is positioned near the transplantation target portion 402 within the lumen 400.

[0060] Subsequently, in the deployment step (step S5 in FIG. 6), as shown in FIG. 13, the support portion 24 and the tubular graft 300 are deployed. Specifically, in the deployment step, the first shaft 22 is gripped and moved in the distal direction (arrow X1 direction) with respect to the outer cylinder 20. As a result, the valve body 26 (see FIG. 2) of the first shaft 22 causes the second shaft 48 to move integrally in the distal direction (arrow X1 direction) together with the first shaft 22. Then, the support portion 24 and the tubular graft 300 exposed from the distal opening 202 of the outer cylinder 20 are arranged in the lumen 400 in a curved shape along the lumen 400. At this time, with the expander 52 inserted into the lumen 400 of the tubular graft 300, the tubular graft 300 and the support portion 24 are deployed and exposed in the lumen 400. In the lumen 400, the support portion 24, the expander 52, and the tubular graft 300 are arranged in the distal direction from the distal end of the outer cylinder 20. In the deployment step, the tubular graft 300 and the expander 52 are arranged inside the curved support portion 24.

[0061] Next, in the movement step (step S6 in FIG. 6), as shown in FIG. 14, by moving the second shaft 48 in the distal direction (arrow X1 direction) with respect to the carrier member 16, the proximal end portion of the tubular graft 300 is pushed in the distal direction (arrow X1 direction) by the pressing portion 50 of the second shaft 48. The tubular graft 300 moves in the distal direction with respect to the support portion 24. That is, the tubular graft 300 protrudes in the distal direction (arrow X1 direction) from the distal end of the support portion 24. Specifically, in the movement step, the second shaft 48 is moved in the distal direction with respect to the first shaft 22. At this time, as shown in FIG. 15, since the tubular graft 300 is non-self-expanding, it is placed in the lumen 400 in a U-shaped open upward without returning to a substantially cylindrical shape in the lumen 400. In the preparation step, the placement step, the accommodation step, the arrangement step, the deployment step, and the movement step described above, the expander 52 is in a contracted state in which it is contracted.

[0062] After the moving step, an expansion step (step S7 in FIG. 6) of expanding the expander 52 inside the tubular graft 300 is performed. The expansion fluid S is introduced into the second lumen 481 from the port 541 of the hub 54 of the expansion member 18. The expansion fluid S is introduced into the inside of the expander 52 through the second lumen 481, and as shown in FIG. 16, the body portion 521 of the expander 52 expands radially outward by the expansion fluid S. The body portion 521 of the expander 52 expands with a substantially constant diameter. The tubular graft 300 is pushed outward in the radial direction by the outer peripheral surface of the expanded body portion 521. As shown in FIG. 17, the tubular graft 300 returns to a substantially cylindrical shape by the expander 52. The tubular graft 300 that has returned to a tubular shape is placed on the transplantation target portion 402 in the lumen 400. At this time, the outer peripheral portion of the tubular graft 300 adheres to the transplantation target portion 402.

[0063] Thereafter, in the removal step (step S8 in FIG. 6), as shown in FIG. 18, after the supply of the expansion fluid S is stopped, the expansion fluid S in the expander 52 is discharged to the outside through the port 541 of the hub 54. Along with the discharge of the expansion fluid S, the expanded expander 52 contracts and the body portion 521 separates from the inner peripheral surface of the tubular graft 300 (refer to the two-dot chain line shape in FIG. 18). After the expander 52 contracts, the second shaft 48 is moved in the proximal direction with respect to the first shaft 22, and the expander 52 is pulled out from the lumen 302 of the tubular graft 300 in the proximal direction. Thereby, the transfer of the tubular graft 300 that has returned to a tubular shape to the transplantation target portion 402 in the lumen 400 is completed. Thereafter, the transfer device 10 is removed from the inside of the lumen 400 with the expander 52 and the support portion 24 accommodated in the outer cylinder 20.

[0064] This embodiment has the following effects.

[0065] As shown in FIG. 1, the transfer device 10 includes a first shaft 22 disposed movably along the axial direction inside an outer cylinder 20, a second shaft 48 provided movably along the first shaft 22 within the outer cylinder 20, and an expandable body 52 provided at the tip of the second shaft 48. The expandable body 52 is expandable and contractible, and is displaceably provided between a housed position housed in the outer cylinder 20 and a protruding position protruding from the tip opening 202 of the outer cylinder 20. As shown in FIG. 16, in a state where the expandable body 52 is positioned at the protruding position, the tubular graft 300 can be expanded by expanding the expandable body 52 inserted into the lumen 302 of the tubular graft 300.

[0066] Thereby, the tubular graft 300 can be efficiently housed in the outer cylinder 20 in a state where the tubular graft 300 is smaller than the outer cylinder 20. In the lumen 400 of a living body, by protruding the expandable body 52 from inside the outer cylinder 20 and expanding the expandable body 52, the non-self-expandable tubular graft 300 can be efficiently arranged at the transplantation target portion 402 within the lumen 400.

[0067] As shown in FIG. 3, the tip of the first shaft 22 is provided with a support portion 24 that can hold the tubular graft 300 and that unfolds by protruding in the tip direction from the tip opening 202 of the outer cylinder 20. The support portion 24 has a support surface 241 on which the tubular graft 300 can be placed. Thereby, by placing the tubular graft 300 on the support surface 241 of the support portion 24, it is easy to hold the tubular graft 300 with respect to the support portion 24.

[0068] The base end portion of the expandable body 52 is connected to the tip portion of the second shaft 48, and the tip portion of the second shaft 48 or the base end portion of the expandable body 52 has a pressing portion 50 that presses the tubular graft 300 in the tip direction. Thereby, as shown in FIG. 14, in a state where the support portion 24 is unfolded, by moving the second shaft 48 in the tip direction, the tubular graft 300 can be effectively transferred toward the transplantation target portion 402 by the pressing portion 50.

[0069] As shown in FIG. 19A, the transfer device 10A according to the first modification includes a carrier member 16 having a support portion 24. The support portion 24 can be inserted into the inner cavity 302 of the tubular graft 300. In this case, the shape of the tubular graft 300 is a substantially flat shape that is deformed by being pushed radially inward. In the placement step, the accommodation step, the arrangement step, and the deployment step, the support portion 24 is inserted into the inner cavity 302 of the tubular graft 300, and the tubular graft 300 is held by the support portion 24. The expandable body 52 is inserted into the inner cavity 302 of the tubular graft 300 together with the support portion 24. As shown in FIG. 19B, when the tubular graft 300 is accommodated in the outer cylinder 20 together with the support portion 24, the outer peripheral portion of the tubular graft 300 contacts the inner peripheral surface of the outer cylinder 20. The support portion 24 is held inside the tubular graft 300. The support portion 24 and the tubular graft 300 are accommodated in the outer cylinder 20 with the front surface 461 and the back surface 462 of the support portion 24 covered by the tubular graft 300.

[0070] The first modification has the following effects.

[0071] As shown in FIG. 19A, by inserting the support portion 24 into the inner cavity 302 of the tubular graft 300, the tubular graft 300 can be held so as to cover the outside of the support portion 24. Therefore, in the placement step, the accommodation step, the arrangement step, and the deployment step, the tubular graft 300 can be held more effectively with respect to the support portion 24.

[0072] As shown in FIG. 20A, the transfer device 10B according to the second modification has a pressing portion 50B at the tip of the first shaft 22 that presses the tubular graft 300 in the tip direction. The pressing portion 50B is the tip surface of the first shaft 22. Note that the pressing portion 50B is not limited to the tip surface of the first shaft 22. For example, as shown by the phantom line in FIG. 20A, the pressing portion 50B may have a protruding shape that protrudes toward the radial center with respect to the tip of the first shaft 22. The transfer device 10B does not have a support portion at the tip of the first shaft 22. In the moving step, when the first shaft 22 and the second shaft 48 are moved in the tip direction with respect to the outer cylinder 20, the base end portion of the tubular graft 300 disposed in the tip direction of the outer cylinder 20 can be pressed in the tip direction by the pressing portion 50B. As shown in FIG. 20B, when the tubular graft 300 is accommodated in the outer cylinder 20, the outer peripheral portion of the tubular graft 300 contacts the inner peripheral surface of the outer cylinder 20. Inside the outer cylinder 20, only the tubular graft 300 is accommodated in a state of being curved in a heart shape along the inner surface of the outer cylinder 20.

[0073] The second modification has the following effects.

[0074] As shown in FIG. 20A, in the lumen 400 of the living body, by moving the first shaft 22 in the tip direction, the base end portion of the tubular graft 300 can be effectively transferred toward the transplantation target portion 402 by the pressing portion 50B. Compared with the configuration (transfer device 10) in which the support portion 24 is provided on the carrier member 16 shown in FIG. 3, the configuration of the transfer device 10B can be simplified and the cost can be reduced.

[0075] As shown in FIG. 21A, the support portion 24 of the transfer device 10C according to the third modification has a holding portion 70C that holds the tubular graft 300 on the support surface 241. The holding portion 70C is provided at the proximal end portion of the support portion 24. The holding portion 70C extends from the proximal end portion of the support portion 24 toward the distal end direction and faces the support surface 241. The holding portion 70C has a pair of holding pieces 72. The proximal ends 721 of the pair of holding pieces 72 are fixed ends connected to the support portion 24. The distal ends 722 of the pair of holding pieces 72 are free ends. The distal ends 722 of the holding pieces 72 are arranged in the proximal end direction relative to the distal end of the support portion 24. Note that the holding portion 70C is not limited to the case of including a pair of holding portions 70C. For example, the holding portion 70C may include one holding piece 72, or may include three or more holding pieces 72. In a plan view of the support portion 24, the pair of holding pieces 72 are separated in the width direction (arrow W direction) of the support portion 24 with the first shaft 22 therebetween. The holding portion 70C is not limited to the case of being provided at the proximal end portion of the support portion 24. For example, the holding portion 70C may be provided at the first protruding portion 38 of the support portion 24, and may be provided so as to extend inward in the width direction from the first protruding portion 38.

[0076] As shown in FIG. 21B, with the tubular graft 300 placed on the support surface 241 of the support portion 24 and the lower surface of the tubular graft 300 in contact with the support surface 241, the upper surface of the tubular graft 300 contacts the pair of holding pieces 72. The tubular graft 300 is held between the support surface 241 of the support portion 24 and the pair of holding pieces 72. Note that the holding pieces 72 of the holding portion 70C are not limited to the configuration of contacting the tubular graft 300. For example, the holding pieces 72 may face the tubular graft 300 and be non-contact with the tubular graft 300.

[0077] The third modification has the following effects.

[0078] Each holding piece 72 of the holding part 70C can hold the tubular graft 300 more effectively on the support surface 241 of the support part 24. That is, the lifting of the tubular graft 300 with respect to the support surface 241 of the support part 24 can be suppressed. As shown in FIG. 21A, since the tubular graft 300 can be held by the holding piece 72 on the proximal end side of the support part 24, when the tubular graft 300 is moved in the distal direction from the support part 24 in the moving step, the holding part 70C does not interfere with the tubular graft 300.

[0079] As shown in FIG. 22, the support part 24 of the transfer instrument 10D according to the fourth modification has a holding part 70D that holds the tubular graft 300 on the support surface 241. The holding part 70D is a pair of first protruding parts 38 that protrude upward from both side parts in the width direction of the support surface 241 orthogonal to the moving direction of the first shaft 22. In the placing step of placing the tubular graft 300 on the support part 24, the corner part 304 of the tubular graft 300 is arranged inside the pair of first protruding parts 38. Thereby, the tubular graft 300 is held by the support part 24 in a state of being supported by the pair of first protruding parts 38 and the support surface 241.

[0080] The fourth modification has the following effects.

[0081] In the placing step, housing step, arranging step, and deploying step of the transfer instrument 10D, the tubular graft 300 can be held by the support part 24 more effectively by the holding part 70D which is the first protruding part 38 of the support part 24. By using the pair of first protruding parts 38 for bending and deforming the tubular graft 300 and housing it in the outer cylinder 20, the tubular graft 300 can be effectively held by the support part 24.

[0082] Note that the present invention is not limited to the above-described disclosure, and various configurations can be adopted without departing from the gist of the present invention.

Explanation of Reference Numerals

[0083] 10, 10A, 10B, 10C, 10D... Transfer instrument 20... Outer cylinder 22... First shaft 48... Second shaft 52…Expansion body 202…Tip opening 300…Tubular graft 302…Lumen 400…Luminal cavity 402…Target site for transplantation P…Patient

Claims

1. A delivery device for delivering a tubular graft having a lumen to a treatment site within a body lumen, comprising: an outer cylinder having a distal opening; a first shaft extending in the axial direction of the outer cylinder and disposed movably along the axial direction inside the outer cylinder; a second shaft extending along the first shaft within the outer cylinder and provided movably along the first shaft; an expandable body provided at the distal end of the second shaft, displaceable between a housed position housed in the outer cylinder and a protruding position protruding from the distal opening of the outer cylinder, and expandable and contractible; wherein the outer cylinder is capable of housing the tubular graft and the expandable body with the expandable body inserted into the lumen of the tubular graft in a contracted state; and the delivery device is capable of expanding the tubular graft by expanding the expandable body inserted into the lumen of the tubular graft with the expandable body positioned at the protruding position.

2. The delivery device according to claim 1, wherein a support portion capable of holding the tubular graft and deploying by protruding distally from the distal opening of the outer cylinder is provided at the distal end of the first shaft; and the support portion has a support surface on which the tubular graft can be placed.

3. The delivery device according to claim 1, wherein a support portion capable of holding the tubular graft and deploying by protruding distally from the distal opening of the outer cylinder is provided at the distal end of the first shaft; and the support portion is inserted into the lumen of the tubular graft.

4. The delivery device according to claim 2 or 3, wherein a proximal end portion of the expandable body is connected to the distal end portion of the second shaft; and the distal end portion of the second shaft or the proximal end portion of the expandable body has a pressing portion for pressing the tubular graft distally.

5. The delivery device according to claim 2 or 3, wherein the distal end portion of the first shaft has a pressing portion for pressing the tubular graft distally.

6. The delivery device according to claim 2, wherein the support portion has a holding portion for holding the tubular graft on the support surface.

7. The delivery device according to claim 6, wherein the holding portion is provided at a proximal end portion of the support portion, extends distally from the proximal end portion, and has a holding piece facing the support surface.

8. In the transfer device according to claim 6, The support portion has a pair of protruding portions protruding upward from both side portions in the width direction of the support surface orthogonal to the moving direction of the first shaft, and the protruding portion is the holding portion, the transfer device.

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