Transfer equipment and manufacturing method thereof

Abstract

To provide a manufacturing method for manufacturing transfer equipment and an external cylinder for transferring a medical sheet to a treatment object part of a living body.SOLUTION: Transfer equipment 10 includes a protrusion wall 94 provided at the tip of an external cylinder 22, which protrudes radially inward. The protrusion wall 94 includes a concave part 102 opened on an outer peripheral surface 22A of the external cylinder 22, and recessed in a protruding direction of the protrusion wall 94 from the outer peripheral surface 22A.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] The present invention relates to a method for manufacturing a delivery device and an outer cylinder for delivering a medical sheet to a treatment target part of a living body. [Background technology]

[0002] Patent Document 1 discloses, for example, a transfer device for transferring a medical sheet (cell sheet) used in organ transplantation to a treatment target part of a living body. This transfer device comprises an outer tube, a shaft movable inside the outer tube, and a support part provided at the tip of the shaft and capable of protruding from the tip of the outer tube. The support part has a sheet support for placing the medical sheet. With the transfer device, with the medical sheet placed on the support surface of the sheet support, the shaft is slid relative to the outer tube, thereby drawing the medical sheet together with the sheet support into the outer tube and storing it within the outer tube. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2022 / 080459 Summary of the Invention [Problem to be solved by the invention]

[0004] It is desirable to efficiently contain the medical sheet within the barrel, while also reducing the weight and amount of material required for the delivery device. [Means for solving the problem]

[0005] (1) A first aspect of the present invention is a transfer device for transferring a medical sheet to a treatment target part of a living body, comprising: an outer tube having a distal opening; a shaft extending in the axial direction of the outer tube and disposed inside the outer tube so as to be movable along the axial direction; a carrier member having a sheet-shaped support portion disposed at the distal end of the shaft; and a protruding wall provided at least at the distal end of the outer tube and protruding radially inward of the outer tube, the support portion including a support surface capable of holding the medical sheet, the protruding wall having a recess that opens into the outer peripheral surface of the outer tube and is recessed from the outer peripheral surface in the protruding direction of the protruding wall, the shaft being moved in a base end direction relative to the outer tube so that the support portion is accommodated within the outer tube. in a first position where the shaft is moved in a distal direction relative to the outer tube so that the support part protrudes from the distal opening of the outer tube, the support part unfolds by being exposed in the distal direction from the outer tube, the support part of the transfer device protrudes in the distal direction from the distal end of the outer tube, and when the support part is moved relatively to the outer tube in the base end direction with the medical sheet placed on it, the support part is guided toward the distal opening of the outer tube, and the protruding wall deforms the support part into a curved shape so that both widthwise sides of the support part protrude toward the support surface.

[0006] According to this transfer device, by moving the support part relative to the outer cylinder in the proximal direction from the second position where the support part is deployed in the distal direction of the outer cylinder, the support part can be deformed into a predetermined curved shape by the protruding wall and accommodated inside the outer cylinder. By providing a recess, it is possible to reduce the weight and material amount of the outer cylinder.

[0007] (2) In the transfer device described in (1) above, the recess may extend from the tip end of the outer cylinder toward the base end and be capable of holding a medical device.

[0008] With this configuration, by accommodating and holding the medical device in the recess of the protruding wall, the radial increase in size of the transfer device can be suppressed compared to when the medical device is attached to the outer circumferential surface of the outer cylinder.

[0009] (3) In the transferring device described in (2) above, the width of the recess in a width direction perpendicular to the extending direction of the protruding wall and the protruding direction may be equal to or smaller than the width of the medical device.

[0010] With this configuration, by accommodating a medical device in the recess, the medical device can be effectively held within the recess by the inner surface of the recess without using a fixing member.

[0011] (4) In the transfer device described in any one of (1) to (3) above, the tip of the protruding wall may be provided with a slit that penetrates the inner cavity of the outer tube and the recess and extends in the axial direction.

[0012] With this configuration, the pair of side walls constituting the protruding wall can be easily elastically deformed by the slits, so that medical devices of various outer diameters can be held in the recess.

[0013] (5) In the transfer instrument described in (2) or (3) above, the medical device may be an endoscope, and a tip of the endoscope may be disposed on the tip side of the protruding wall.

[0014] With this configuration, the treatment target part and the support part of the living body can be confirmed by the endoscope provided at the tip of the outer cylinder.

[0015] (6) In the transfer device according to any one of (1) to (5) above, the protruding wall and the recess may extend from the tip end to the base end of the outer cylinder.

[0016] With this configuration, the protruding wall and the recessed portion can be easily formed when the outer cylinder is formed by extrusion molding.

[0017] (7) In the transferring device according to any one of (1) to (6) above, the recess may be open in a distal direction at a distal end of the outer cylinder. This configuration allows

[0018] With this configuration, the medical instrument can be moved in the distal direction (towards the treatment target part of the living body and the support part) through the distal end of the open recess.

[0019] (8) In the transfer device described in any one of (1) to (7) above, when the radius of a circle along the inner surface of the outer tube excluding the protruding wall is R and pi is π, the width of the support portion in a direction perpendicular to the extension direction of the shaft may be greater than 2πR.

[0020] This configuration makes it possible to effectively accommodate a support portion having a width greater than the length of the inner peripheral surface of the outer cylinder excluding the protruding wall within the outer cylinder.

[0021] (9) A second aspect of the present invention is a manufacturing method for producing an outer tube of a transfer device, comprising the steps of: providing a tubular member that serves as a material for the outer tube; and pressing an outer periphery of the tubular member radially inward to recess a portion of the outer periphery, thereby forming the outer tube with the protruding wall having the recess.

[0022] According to this method for manufacturing the outer cylinder, the protruding wall including the recessed portion can be easily formed on the outer cylinder. The protruding wall can be formed on a portion of the outer cylinder in the axial direction. Effect of the Invention

[0023] According to the present invention, the outer cylinder has a protruding wall provided at the tip end thereof and protruding inward in the radial direction, and the protruding wall has a recess that opens into the outer peripheral surface of the outer cylinder and is recessed from the outer peripheral surface in the protruding direction of the protruding wall. Therefore, by moving the support part relative to the outer cylinder in the base end direction from the second position where the support part is deployed in the tip end direction of the outer cylinder, the support part can be deformed into a predetermined curved shape by the protruding wall and accommodated inside the outer cylinder. By providing the recess, it is possible to reduce the weight and the amount of material of the outer cylinder. [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 an enlarged perspective view showing the tip portion of the outer cylinder. [Figure 7] Fig. 7A is a front view of the tip of an outer cylinder, and Fig. 7B is a front view of the tip of an outer cylinder having a recess according to a modified example. [Figure 8] FIG. 8 is a flow chart showing the steps of a method for transferring a medical sheet using the transfer device of FIG. [Figure 9] FIG. 9 is a first explanatory view of the sheet placing step. [Figure 10] FIG. 10 is a second explanatory view of the sheet placing step. [Figure 11] FIG. 11 is a first explanatory view of the accommodation step. [Figure 12] FIG. 12 is a second explanatory view of the accommodation step. [Figure 13] FIG. 13 is a cross-sectional view taken along line XIII-XIII in FIG. [Figure 14] FIG. 14 is an explanatory diagram of the arrangement process. [Figure 15] FIG. 15 is a first explanatory diagram of the development process. [Figure 16] FIG. 16 is a second explanatory diagram of the unfolding step. [Figure 17] FIG. 17 is an explanatory diagram of the movement process. [Figure 18] FIG. 18 is an explanatory diagram of the removal step. [Figure 19] FIG. 19 is a front view of the tip of an outer cylinder having a protruding wall according to a modified example. [Figure 20] Fig. 20A is a first explanatory view of a method for manufacturing an outer cylinder, and Fig. 20B is a second explanatory view of a method for manufacturing an outer cylinder. 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 Figs. 14 to 18). 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 pair of first protrusions 38, a pair of second protrusions 40, and a distal 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. That is, the marker 551 allows the user to confirm the direction of the first support surface 261 in the first support portion 26.

[0038] 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. 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 second protrusions 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 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 second protrusions 40.

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

[0041] In Fig. 2 and Fig. 3, the pair of first protrusions 38 protrude upward (arrow Y direction) 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 pair of first protrusions 38 are connected to the base end support part 34. The first protrusions 38 are arc-shaped and protrude in a convex shape in a direction away from the first support surface 261. As shown in Fig. 3, the pair of second protrusions 40 are connected to the tips of the pair of first protrusions 38, respectively. The pair of second protrusions 40 protrude upward and outward in the width direction of the intermediate support part 36 from both sides in the width direction of the intermediate support part 36. The second protrusions 40 are formed with a smaller curvature than the first protrusions 38. The second protrusions 40 have a lower protruding height from the first support surface 261 than the first protrusions 38.

[0042] Each of the pair of first protruding portions 38 has a pair of bent portions 444. Each of the pair of bent portions 444 bends the pair of first protruding portions 38 toward the first supporting surface 261 (middle supporting portion 36) of the first supporting portion 26 (see FIG. 5).

[0043] 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 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.

[0044] As shown in FIG. 2, the second carrier member 20 includes a second shaft 48 , a second support portion 50 , and a hub 52 .

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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. 17).

[0050] 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.

[0051] 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 on is provided on the upper surface of the second support body 72. The second support surface 74 is a 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.

[0052] In FIG. 2, the hub 52 is attached to the proximal end of the second shaft 48 .

[0053] 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.

[0054] 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.

[0055] As shown in FIG. 2, the endoscope 14 has a long endoscope body 86. The endoscope body 86 is fixed to the outer periphery of the outer tube 22 (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 (arrow X1 direction). The objective lens 88 is provided at the tip 141 of the endoscope 14. The tip of the endoscope body 86 is fixed to the axial tip of the outer tube 22. A fixing member 16 capable of fixing the endoscope 14 is attached to the outer periphery of the outer tube 22. The fixing member 16 has, for example, a fixing tube 92. The fixing tube 92 is, for example, a heat shrink tube.

[0056] As shown in FIG. 3, hereinafter, the combined portion of the first protrusion 38 and the second protrusion 40 of the first support portion 26 is referred to as the "protrusion 37". Therefore, a pair of protrusions 37 is provided on both sides of the width direction of the first support portion 26. 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 portion 26. The W direction is also the width direction of other components (such as the outer tube 22). In this embodiment, the first support portion 26 has a pair of protrusions 37, and W1 in FIG. 3 is the width of the portion where the width of the first support portion 26 is maximum when the first support portion 26 is developed in a planar state. In other words, the width W1 of the first support portion 26 is the maximum width of the first support portion 26P in a planar state before the pair of protrusions 37 are formed (before bending). When the radius of an imaginary circle Lc (see the dotted line shape in Figure 13) along the inner surface of the outer tube 22 excluding the protruding wall 94 is R and pi is π, the width W1 of the first support portion 26 in a direction perpendicular to the extension direction of the first shaft 24 is greater than 2πR.

[0057] As shown in Fig. 6, the outer cylinder 22 has a protruding wall 94. The protruding wall 94 extends from the tip of the outer cylinder 22 toward the base end (the direction of the arrow X2) and protrudes radially inward of the outer cylinder 22. The protruding wall 94 protrudes into the inner cavity 78 of the outer cylinder 22. As shown in Fig. 7A, the protruding wall 94 has a predetermined width in a width direction perpendicular to the protruding direction of the protruding wall 94 and perpendicular to the axial direction of the outer cylinder 22. The outer cylinder 22 is formed, for example, by extrusion molding from a resin material along the axial direction.

[0058] 2, the protruding wall 94 extends linearly from the tip to the base end of the outer tube 22. The protruding wall 94 is not limited to being formed over the entire axial direction of the outer tube 22. The protruding wall 94 may be provided over only a portion of the axial direction of the outer tube 22, so long as it includes at least the tip of the outer tube 22.

[0059] 7A, the protruding wall 94 has a base 96 fixed to the outer periphery of the outer cylinder 22, a vertical wall portion 98 protruding downward from the base 96, a curved surface portion 100 connecting the base 96 and the vertical wall portion 98, and a recessed portion 102 capable of accommodating a medical device P. When viewed from the axial direction of the outer cylinder 22, the protruding wall 94 is disposed on an imaginary line D1 that passes through the central axis of the outer cylinder 22 and extends in the radial direction.

[0060] The base 96 is a fixed end connected to the peripheral wall of the outer tube 22. The vertical wall 98 protrudes radially inward from the base 96 of the outer tube 22. A protruding end 981 of the vertical wall 98 is a free end spaced radially from the base 96, which is the fixed end. The protruding end 981 is the lower end of the vertical wall 98. The protruding end 981 of the vertical wall 98 is formed in an arc shape that is convex downward. The vertical wall 98 has a pair of side walls 982 extending radially. The pair of side walls 982 face the inner cavity 78 of the outer tube 22, and are spaced apart from each other and parallel to each other in the width direction (W direction) perpendicular to the extension direction of the protruding wall 94.

[0061] The curved surface portions 100 connect each of the pair of side walls 982 to the inner surface of the base portion 96. The curved surface portions 100 have an arc shape that is convex radially outward.

[0062] The recess 102 is formed inside the protruding wall 94 and extends from the tip end of the outer tube 22 toward the base end (arrow X2 direction) (see FIG. 6). The recess 102 extends from the base 96 to the tip 981 of the vertical wall 98. The recess 102 opens to the outer peripheral surface 22A of the outer tube 22. That is, the recess 102 is recessed from the outer peripheral surface 22A of the outer tube 22 in the protruding direction of the protruding wall 94 (diametrically inward of the outer tube 22). The recess 102 can accommodate and hold the medical device P. That is, the protruding wall 94 has a hollow shape having the recess 102 inside. The width of the recess 102 is approximately constant in the extending direction of the protruding wall 94 (arrow X1, X2 direction in FIG. 6) and in the width direction (W direction) perpendicular to the protruding direction. The medical device P is, for example, an endoscope 14 for checking a transplantation target portion 402 of a living body, forceps for performing a treatment on the transplantation target portion 402, a liquid supply tube for supplying a liquid (physiological saline) to the transplantation target portion 402, etc. Hereinafter, a case where the endoscope 14 is used as the medical device P will be described.

[0063] The recess 102 has an opening 1021 that opens to the outer periphery of the outer cylinder 22 , a bottom 1022 that is spaced radially inward from the opening 1021 , and a recess opening 1023 .

[0064] The opening 1021 is provided in the base 96 of the protruding wall 94. The bottom 1022 is provided in the tip 981 of the vertical wall 98. The bottom 1022 corresponds to the tip 981 of the vertical wall 98, for example, and is formed in an arc shape that is convex downward. As shown in FIG. 6, the recess opening 1023 is disposed at the tip of the recess 102. The recess opening 1023 opens at the tip of the outer tube 22. When the outer tube 22 is extrusion molded along the axial direction, the protruding wall 94 including the recess 102 is formed integrally with the outer tube 22. The endoscope 14 is inserted along the extension direction of the recess 102.

[0065] The endoscope 14 (endoscope body 86) is inserted into the recess 102 of the protruding wall 94, and the endoscope 14 is housed along the extension direction of the recess 102 (protruding wall 94). The endoscope 14 is inserted into the recess 102 through the opening 1021, and the endoscope 14 is pushed along the recess 102 to the bottom 1022, whereby the endoscope 14 is held in the recess 102. At this time, the width of the recess 102 is approximately equal to or smaller than the outer diameter of the endoscope 14. The outer surface of the endoscope 14 is clamped and held by the inner surface of the recess 102. Note that this is not limited to the case where the endoscope 14 is disposed at the bottom 1022 of the recess 102. For example, as shown by the two-dot chain line in FIG. 7A, the endoscope 14 may be held between the bottom 1022 and the opening 1021 in the protruding direction of the protruding wall 94.

[0066] The width of the recess 102 is not limited to being equal to or smaller than the outer diameter of the endoscope 14. For example, the width of the recess 102 may be greater than the outer diameter of the endoscope 14. In this case, the fixing tube 92 attached to the outer peripheral surface 22A of the outer cylinder 22 prevents the endoscope 14 from coming off the recess 102.

[0067] The tip 141 of the endoscope 14 having the objective lens 88 is placed in the recess opening 1023. As shown in Fig. 2, the base end of the endoscope 14 is taken out from the base end of the recess 102 to the outside of the outer tube 22. With the endoscope main body 86 housed in the recess 102, a fixing tube 92 is attached to the outer circumferential surface 22A of the outer tube 22.

[0068] The width of the recess 102 is not limited to be substantially constant in the width direction (W direction) of the protruding wall 94. For example, the recess 102A of the protruding wall 94A shown in FIG. 7B is formed so that the width from the bottom 1022 to the opening 1021 is smaller than the width of the bottom 1022. The width of the bottom 1022 is substantially the same as the outer diameter of the endoscope 14. This prevents the endoscope 14 housed and held in the bottom 1022 from moving toward the outer periphery of the outer tube 22.

[0069] 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. 14 to Fig. 18, 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. 8, 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.

[0070] 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 and second shafts 24, 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.

[0071] Next, in the sheet placement step (step S2), as shown in Fig. 9, the medical sheet 300 placed in the petri dish 401 is placed on the second support surface 74. Note that, as shown in Fig. 10, the medical sheet 300 protrudes outward from the second support part 50 when placed on the second support surface 74. The first support surface 261 supports the protruding part 302 of the medical sheet 300 that protrudes outward from the second support part 50. The pair of second protrusions 40 suppress movement (displacement) of the medical sheet 300 in the width direction of the intermediate support part 36 when the medical sheet 300 is placed on the second support surface 74.

[0072] Thereafter, in a storage step (step S3 in FIG. 8), the medical sheet 300 is placed in a storage position (first position) together with the first support part 26 and the second support part 50 in the outer cylinder 22. 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.

[0073] As the first and second carrier members 18, 20 move relative to the outer tube 22 in the proximal direction, as shown in FIG. 11, the proximal support portion 34 of the first support portion 26 is drawn from the distal end opening 80 of the outer tube 22 in the proximal direction (the direction of the arrow X2). At this time, both sides of the proximal support portion 34 come into contact with the side walls 982 of the vertical wall portion 98 of the protruding wall 94, so that a force acts on the proximal support portion 34 to curl the proximal support portion 34 toward the vertical wall portion 98. Therefore, the proximal support portion 34 is drawn smoothly in the proximal direction along the inner cavity 78 of the outer tube 22 while gradually curling along the vertical wall portion 98 toward the proximal direction. At this time, the first support portion 26 is accommodated in the inner cavity 78 of the outer tube 22 along the protruding wall 94 while curling in a conical shape so that the distal end side has a large diameter and the proximal support portion 34 has a small diameter.

[0074] When the base end support portion 34 is deformed, a force acts on the intermediate support portion 36 to curl up along the circumferential direction of the outer tube 22, so that the intermediate support portion 36 is deformed into a cylindrical shape while being curled up along the inner surface of the outer tube 22 and the side wall 982 of the vertical wall portion 98 of the protruding wall 94. At this time, each of the pair of first 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, so that the pair of first protruding portions 38 is rolled up inward by the vertical wall portion 98 at the center of the width of the protruding wall 94 (see FIG. 13). As shown in FIG. 13, the back surfaces 462 of the intermediate portions 443 that bulge outward in a convex shape in the radial direction face each other across the vertical wall portion 98, centered on a virtual line D2 extending perpendicular to the central axis of the outer tube 22.

[0075] As a result, the back surface 462 of the first support portion 26 is curved in close contact with the inner surface of the outer tube 22 and the inner surface of the protruding wall 94, and each of the first protruding portions 38 is further curved so as to be folded back toward the center of the outer tube 22, and the outer edge portion is disposed below the tip end 981 of the vertical wall portion 98. The outer edge portion of the first support portion 26 may be disposed above the tip end 981 of the vertical wall portion 98. At this time, since the vertical wall portion 98 of the protruding wall 94 is disposed to face the center of the width direction of the first support portion 26, the first support portion 26 is folded so as to have a symmetrical shape with the vertical wall portion 98 sandwiched therebetween, and is curved into a heart shape along the inner surface. As the first support portion 26 is curved and deformed, the second support portion 50 is also curved and deformed along the first support portion 26 on the inside (surface 461 side) of the first support portion 26. As the first and second support parts 26, 50 are curved, the medical sheet 300 is deformed into a shape corresponding to the shapes of the first and second support bodies 32, 72.

[0076] 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 inner cavity 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. 13).

[0077] 11, the first and second carrier members 18, 20 are moved toward the base end relative to the outer tube 22, whereby the first support part 26, which has been curved and deformed into a heart shape at the tip of the outer tube 22, is further drawn into and accommodated in the inner cavity 78 of the outer tube 22 (see FIG. 12). In the inner cavity 78 of the outer tube 22, the first support part 26 comes into contact with the inner surface of the inner cavity 78, whereby the first support part 26 is accommodated in a state in which the heart shape of the first support part 26 is maintained along the inner surface.

[0078] 12, the accommodating step is completed when the entire first support part 26 is completely accommodated in the outer tube 22. The accommodated position is a position where the first shaft 24 is moved in the proximal direction (the direction of the arrow X2) relative to the outer tube 22 so that the first support part 26 is accommodated in the inner cavity 78 of the outer tube 22, and the first support part 26 is accommodated in the inner cavity 78 of the outer tube 22 in a curved and deformed state. When the accommodating step is completed, a part of the first support part 26 may protrude from the distal end opening 80 of the outer tube 22. In this case, the state where a part of the first support part 26 protrudes from the distal end opening 80 of the outer tube 22 is the first position of the first support part 26.

[0079] When the first support portion 26, the second support portion 50 and the medical sheet 300 are housed within the outer tube 22, as shown in FIG. 13, the pair of first protrusions 38 are positioned further forward (in the direction of arrow X1) than the pressing surface 58 of the pressing portion 56, with the back surfaces 462 spaced apart from each other in the width direction (W direction) by the protruding wall 94.

[0080] Thereafter, in a placement step (step S4 in FIG. 8), as shown in FIG. 14, 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 transplantation target portion 402 in the heart 400. As a result, the tip 141 (objective lens 88) of the endoscope 14 arranged at the tip of the outer cylinder 22 faces the transplantation target portion 402. The endoscope 14 makes it possible to check the surroundings of the transplantation target portion 402. Note that before inserting the transfer instrument 10 into the thoracic cavity 410, a liquid supplying instrument (not shown) may be connected to the connection port portion of the hub 52 to introduce liquid (e.g., physiological saline).

[0081] Next, in the unfolding step (step S5 in FIG. 8), the first support part 26, the second support part 50, and the medical sheet 300 are unfolded as shown in FIG. 15. 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) as a unit. 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 and the medical sheet 300 spread out in a planar shape. At this time, the unfolded state of the medical sheet 300 can be confirmed by the endoscope 14 arranged at the tip of the outer tube 22.

[0082] In the unfolding step, as shown in Fig. 16, by arranging the tip 141 of the endoscope 14 in the distal direction (arrow X1 direction) further forward than the tip of the outer cylinder 22, the objective lens 88 can be brought closer to and above the medical sheet 300. The unfolded state of the medical sheet 300 can be confirmed in more detail by the endoscope 14. At this time, it is more preferable to bend the tip 141 of the endoscope 14 upward with respect to the extension direction of the outer cylinder 22 so that the tip 141 of the endoscope 14 is approximately parallel to the medical sheet 300. By arranging the endoscope 14 approximately parallel to and above the medical sheet 300, it becomes possible to visually check the medical sheet 300 with a wide field of view from above the first support part 26.

[0083] 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.

[0084] 17, 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.

[0085] As a result, the second support part 50 moves in the distal direction (arrow X1 direction) relative to the first support part 26. At this time, when the pressing surface 58 of the carrier holding part 54 (pressing part 56) presses the outer peripheral end face 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 protruding part 302 of the medical sheet 300 is brought into contact with the transplant target part 402. At this time, the positioning status of the medical sheet 300 relative to the transplant target part 402 can be confirmed by the endoscope 14 arranged at the tip of the outer cylinder 22.

[0086] Then, in the removal step (step S7 in FIG. 8), as shown in FIG. 18, 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. This brings the entire medical sheet 300 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.

[0087] This embodiment provides the following advantages.

[0088] As shown in Fig. 6, the outer tube 22 includes a protruding wall 94 that protrudes radially inward of the outer tube 22, and the protruding wall 94 has a recess 102 that opens on the outer peripheral surface 22A of the outer tube 22 and recesses in the protruding direction of the protruding wall 94 from the outer peripheral surface 22A. As a result, as shown in Fig. 9, by moving the first support part 26 relative to the outer tube 22 in the base end direction (arrow X2 direction) from the second position where the first support part 26 is exposed and deployed from the tip opening 80 of the outer tube 22, the first support part 26 can be deformed into a predetermined curved shape by the protruding wall 94 and accommodated inside the outer tube 22. In addition, by providing the recess 102 in the protruding wall 94, the weight of the outer tube 22 and the amount of material can be reduced.

[0089] 2, the recess 102 extends from the tip end of the outer tube 22 toward the base end (the direction of the arrow X2) and is formed to be able to hold a medical instrument P (endoscope 14). As a result, by accommodating and holding the medical instrument P in the recess 102 of the protruding wall 94, it is possible to prevent the conveying instrument 10 from becoming larger in the radial direction compared to the case where the medical instrument P is attached to the outer peripheral surface 22A of the outer tube 22.

[0090] 7A, in a width direction (W direction) perpendicular to the extending direction and protruding direction of the protruding wall 94, the width of the recess 102 is equal to or less than the width of the medical instrument P. Thereby, by inserting the medical instrument P into the recess 102, the medical instrument P can be effectively held in the recess 102 by the inner surface of the recess 102 without using a fixing member.

[0091] 3, the medical device P is an endoscope 14, and a tip 141 of the endoscope 14 is disposed on the tip side of the protruding wall 94. This allows the transplantation target portion 402 and the first support portion 26 of the living body to be confirmed by the endoscope 14 provided at the tip of the outer tube 22.

[0092] As shown in FIG. 1, the protruding wall 94 and the recessed portion 102 extend from the tip to the base end of the outer tube 22, so that the protruding wall 94 and the recessed portion 102 can be easily formed when the outer tube 22 is formed by extrusion molding.

[0093] 6, the recess 102 opens in the distal direction at the distal end of the outer cylinder 22. This allows the medical device P to be moved in the distal direction (toward the transplantation target part 402 of the living body and the first support part 26) through the open distal end of the recess 102, as shown in FIG.

[0094] 13, when the radius of an imaginary circle Lc along the inner circumferential surface of the outer cylinder 22 excluding the protruding wall 94 is R and pi is π, the width W1 (see FIG. 3) of the first support part 26 in the direction perpendicular to the extension direction of the first shaft 24 is greater than 2πR. This makes it possible to effectively accommodate the first support part 26, which has a width W1 greater than the length of the inner circumferential surface of the outer cylinder 22 excluding the protruding wall 94, inside the outer cylinder 22.

[0095] A conveying device 10A according to a modified example shown in Fig. 19 includes a protruding wall 104 on an outer cylinder 22. The protruding wall 104 has a slit 106 at a tip end 981 of a vertical wall portion 98. The slit 106 radially penetrates the tip end 981 of the vertical wall portion 98. The slit 106 communicates, for example, between a bottom 1022 of the recess 102 and an inner cavity 78 of the outer cylinder 22. The slit 106 is not limited to being formed at the tip end 981 of the vertical wall portion 98.

[0096] The slits 106 extend along the extending direction of the protruding wall 104 (the axial direction of the outer cylinder 22). The slits 106 are disposed over the entire area of ​​the extending direction of the protruding wall 104. In the width direction of the protruding wall 104, one side wall 982 and the other side wall 982 can swing relative to each other with the base 96 as the base point (see the two-dot chain line shape in FIG. 19). In other words, the upper ends of the pair of side walls 982 are fixed ends, and the lower ends of the pair of side walls 982 are free ends.

[0097] When attaching an endoscope 14A having an outer diameter larger than the width of the recess 102, when the endoscope 14A is inserted into the recess 102 from the opening 1021 toward the bottom 1022, the lower ends of the pair of side walls 982 are elastically deformed by the slits 106 so as to move away from each other, and spread outward in the width direction. That is, the lower ends of the pair of side walls 982 swing outward in the width direction with their upper ends as base points. As a result, the endoscope 14A is held by the lower end of the protruding wall 104 (the bottom 1022 of the recess 102) that spreads in the width direction.

[0098] The modified example has the following effects.

[0099] 19, the tip 981 of the protruding wall 104 has a slit 106 that penetrates the inner cavity 78 of the outer cylinder 22 and the recess 102 and extends in the axial direction. Thus, the provision of the slit 106 allows the pair of side walls 982 that constitute the protruding wall 104 to easily deform elastically. Therefore, medical devices P of various outer diameters can be effectively held in the recess 102.

[0100] The manufacturing method for manufacturing the outer cylinder 22 is not limited to the method of extruding the outer cylinder 22 in the axial direction. The outer cylinder 22 may be manufactured by the manufacturing method shown in Figures 20A and 20B.

[0101] 20A, the manufacturing method of the outer tube 22 first includes a step of providing a tubular member C that is a material for the outer tube 22. The tubular member C is a tube formed from a resin material and has a circular cross section. An outer periphery C1 of the tubular member C forms a part of the outer periphery 22A of the outer tube 22.

[0102] Next, a process of forming the outer cylinder 22 having the protruding wall 94 is performed. In a state where the tubular member C is heated, as shown in FIG. 20B, the tip portion J1 of the jig J is pressed against the outer periphery C1 from the radially outward side of the outer periphery C1. The tip portion J1 of the jig J has a shape corresponding to the shape of the recess 102. The pressing direction of the jig J is the direction in which the tip portion J1 of the jig J faces the central axis of the tubular member C. The tubular member C is heated and soft enough to be deformed. Therefore, by bringing the tip portion J1 of the jig J into contact with the outer periphery C1 and pressing it radially inward against the outer periphery C1, a part of the outer periphery C1 is deformed so as to be recessed by the tip portion J1. By recessing a part of the outer periphery C1 radially inward, the protruding wall 94 is formed protruding inside the tubular member C. A recess 102 corresponding to the shape of the jig J is formed inside the protruding wall 94. As a result, the outer cylinder 22 having the protruding wall 94 having the recess 102 is formed.

[0103] In the step of forming the outer tube 22, instead of heating the tubular member C, at least the tip portion J1 of the jig J may be heated, and the outer circumferential portion C1 of the tubular member C may be deformed radially inward by the heated tip portion J1 of the jig J. Both the tubular member C and the jig J may be heated.

[0104] The manufacturing method for the outer cylinder 22 includes a step of providing a tubular member C that is a material for the outer cylinder 22, and a step of pressing an outer circumferential portion C1 of the tubular member C radially inward to recess a portion of the outer circumferential portion C1, thereby forming the outer cylinder 22 with a protruding wall 94 having a recess 102. This makes it possible to easily form the protruding wall 94 including the recess 102 on the outer cylinder 22. The protruding wall 94 can be formed on a portion of the outer cylinder 22 in the axial direction.

[0105] Furthermore, the manufacturing method of the outer cylinder 22 is not limited to the above-mentioned manufacturing method. For example, the outer cylinder 22 may be formed into a cylindrical shape by bending a flat plate.

[0106] 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]

[0107] 10, 10A...Transportation equipment 18...First carrier member 22…Outer cylinder 22A…Outer surface 24…First shaft 26...First support part 94, 104...Protruding wall 96...Base 102...Recess

Claims

1. A transfer device for transferring a medical sheet to a treatment target part of a living body, An outer cylinder having a tip opening; a carrier member including 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 end of the shaft; a protruding wall provided at least at a tip portion of the outer cylinder and protruding radially inward of the outer cylinder; Equipped with the support portion includes a support surface capable of holding the medical sheet, the protruding wall has a recess that opens into an outer circumferential surface of the outer cylinder and is recessed from the outer circumferential surface in a protruding direction of the protruding wall, At a first position where the shaft is moved in a proximal direction relative to the outer cylinder so that the support portion is accommodated in the outer cylinder, the support portion is accommodated in the outer cylinder in a curved and deformed state, 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 a distal opening of the outer tube, the support portion is exposed in the distal direction from the outer tube and deployed, a transfer device in which the support portion of the transfer device protrudes in the tip direction from the tip portion of the outer tube, and when the support portion is moved relative to the outer tube in the base end direction with the medical sheet placed on the support portion, the support portion is guided toward the tip opening of the outer tube, and the protruding wall deforms the support portion into a curved shape so that both widthwise sides of the support portion protrude toward the support surface.

2. 2. The transfer device of claim 1, The recess extends from the distal end of the barrel in a proximal direction and is capable of holding a medical device.

3. 3. The transfer device of claim 2, A transfer instrument, wherein the width of the recess in a width direction perpendicular to the extension direction of the protruding wall and the protruding direction is equal to or less than the width of the medical device.

4. A transfer device according to any one of claims 1 to 3, A transfer device, wherein a tip end of the protruding wall is provided with a slit penetrating the inner cavity of the barrel and the recess and extending in the axial direction.

5. 3. The transfer device of claim 2, A delivery tool, wherein the medical instrument is an endoscope, and a tip of the endoscope is disposed on the distal side of the protruding wall.

6. A transfer device according to any one of claims 1 to 3, The protruding wall and the recess extend from a distal end to a proximal end of the barrel.

7. 3. The transfer device of claim 2, The recess is open toward the tip end of the outer cylinder.

8. 2. The transfer device of claim 1, A transfer device, wherein when the radius of a circle along the inner surface of the outer tube excluding the protruding wall is R and pi is π, the width of the support portion in a direction perpendicular to the extension direction of the shaft is greater than 2πR.

9. 2. A method for producing a transfer device sleeve as claimed in claim 1, comprising the steps of: providing a tubular member that will be used to make the outer cylinder; and pressing an outer circumferential portion of the tubular member radially inward to recess a portion of the outer circumferential portion, thereby forming the outer cylinder having the protruding wall having the recess.

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