Medical devices

Abstract

To provide a medical tool capable of reducing deformation of a medical sheath due to sterilization treatment.SOLUTION: The medical tool comprises a base material sheet, a medical sheath, and a first stationary member which is at least partially disposed in the lumen of the medical sheath and detachably fixes the medical sheath to the base material sheet.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] The present invention relates to a medical device that reduces deformation of a medical sheath associated with sterilization treatment.

Background Art

[0002] Conventionally, long medical devices with flexibility such as catheters were often fixed to a backing sheet and packaged in a bag in an unused state. For example, Patent Document 1 discloses a medical device holding backing sheet made of a long sheet material that is stored in a bag-shaped package while holding a medical device having a flexible linear portion. The backing sheet includes a holding portion for holding the medical device. The holding portion is formed by bending the sheet material in a V shape along the longitudinal direction of the sheet material, and has a V-shaped groove for storing the linear portion of the medical device, and a W-shaped groove formed by folding the valley portion of the V-shaped groove in the opposite direction into a mountain shape at the base end portion of the V-shaped groove. Patent Document 2 discloses a medical device packaging member characterized in that a paper or a thin flat plate or dish-shaped body made of a soft synthetic resin is cut to form a single or a plurality of restraining pieces, a cut having an arch-shaped one end portion is provided at substantially the central portion of the restraining piece, and a pressure-relieving portion is formed by cutting from the arch-shaped end portion of the cut to the end portion of the restraining piece, and the restraining piece is bent at a bent portion from the base end portion.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] Conventionally, long medical instruments were often sterilized while fixed to a cardboard backing and packaged in a bag, as described in Patent Documents 1 and 2. Sterilization methods using high-pressure steam or heat sterilization gases in a heated environment were employed, but in the case of medical sheaths, for example, heating while the medical sheath was pressed down by the holding part of the cardboard backing could cause the medical sheath to deform. The present invention has been made in view of the above-mentioned problems, and its purpose is to provide a medical device that can reduce the deformation of medical sheaths during sterilization. [Means for solving the problem]

[0005] The medical device according to an embodiment of the present invention that has been able to solve the above problems is as follows. [1] A medical device comprising a base sheet, a medical sheath, and a first fixing member, at least a portion of which is disposed in the lumen of the medical sheath and detachably fixes the medical sheath to the base sheet.

[0006] As described above, since at least a portion of the first fixing member is positioned within the lumen of the medical sheath, the lumen side of the medical sheath can be supported, thereby reducing deformation of the medical sheath.

[0007] The medical device according to the embodiment is preferably one of the following [2] to

[16] . [2] The medical device according to [1], wherein the first fixing member has a first fixing portion that extends in a first direction and is fixed to the base sheet at one end in the first direction. [3] Furthermore, it has a second fixing member that extends in a second direction and at least a portion of which is positioned in the lumen of the medical sheath and detachably fixes the medical sheath to the base sheet, the second fixing member having a second fixing portion fixed to the base sheet at one end in the second direction, The other end of the second fixing member in the second direction is opposite to the other end of the first fixing member in the first direction [2], the medical device. [4] The first fixing member has a first widened portion adjacent to the first fixing portion, which widens toward the first fixing portion. The medical device according to [3], wherein the second fixing member has a second widening portion adjacent to the second fixing portion, which widens toward the second fixing portion. [5] The first fixing member has a first fixed width portion of a certain width in the portion adjacent to the first widening portion, The medical device according to [4], wherein the second fixing member has a second fixed width portion of a certain width in the portion adjacent to the second widening portion. [6] The first fixing member and the second fixing member each have an unfixed portion that is not fixed to the base sheet, and at least a portion of the unfixed portion is located in the lumen of a medical sheath, as described in any one of [3] to [5]. [7] The medical device according to [6], wherein the length of the non-fixed portion of the first fixing member in the first direction is longer than the length of the non-fixed portion of the second fixing member in the second direction. [8] The medical device according to [6] or [7], wherein the non-fixed portion of the first fixing member and the non-fixed portion of the second fixing member are each flap-shaped. [9] The medical device according to any one of [3] to [8], wherein the first fixing member and the second fixing member are not in contact.

[10] The first fixing member has a second fixing portion fixed to the base sheet at the other end of the first fixing member in the first direction, as described in [2].

[11] The width of the portion of the first fixing member that is positioned in the lumen of the medical sheath is smaller than the diameter of the lumen of the medical sheath. [1] to

[10] The medical device according to any one of these.

[12] The width of the portion of the second fixing member that is positioned in the lumen of the medical sheath is smaller than the diameter of the lumen of the medical sheath. [3] to [9] The medical device according to any one of these.

[13] The first fixing member is in the form of a sheet. The medical device according to any one of [1] to

[12] .

[14] The second fixing member is sheet-shaped and is the medical device according to any one of [3] to [9].

[15] The medical sheath is the medical device according to any one of [1] to

[14] and has a cut extending in the axial direction.

[16] The medical device according to

[15] , wherein at least a part of the first fixing member is sandwiched between the cuts of the medical sheath.

Advantages of the Invention

[0008] According to the present invention, it is possible to provide a medical device that can reduce deformation of a medical sheath associated with sterilization treatment.

Brief Description of the Drawings

[0009] [Figure 1] FIG. 1 is a plan view of a medical device according to the first embodiment. [Figure 2] FIG. 2 is a cross-sectional view showing the A-A cross-section of FIG. 1. [Figure 3] FIG. 3 is a plan view of the sheet before arranging the medical sheath of FIG. 1. [Figure 4] FIG. 4 is a plan view of an example of a medical sheath. [Figure 5] FIG. 5 is a plan view of a medical device according to the second embodiment. [Figure 6] FIG. 6 is a plan view of the sheet before arranging the medical sheath of FIG. 5. [Figure 7] FIG. 7 is a plan view of a medical device according to the third embodiment. [Figure 8] FIG. 8 is a cross-sectional view showing the B-B cross-section of FIG. 7. [Figure 9] FIG. 9 is a plan view of the sheet before arranging the medical sheath of FIG. 7. [Figure 10] FIG. 10 is a cross-sectional view according to a modified example of the B-B cross-section of FIG. 8.

Modes for Carrying Out the Invention

[0010] Hereinafter, the present invention will be described more specifically based on the following embodiments. However, the present invention is not limited by the following embodiments, and it is of course possible to appropriately modify and implement within the scope that can conform to the gist of the foregoing and following descriptions, and all of them are included in the technical scope of the present invention. In each drawing, for convenience, member codes and the like may be omitted, but in such cases, reference shall be made to the specification and other drawings. Also, the dimensions of various members in the drawings may differ from the actual dimensions because priority is given to facilitating the understanding of the features of the present invention.

[0011] The medical device according to the embodiment of the present invention has a base sheet, a medical sheath, and a first fixing member at least a part of which is disposed in the lumen of the medical sheath and detachably fixes the medical sheath to the base sheet.

[0012] As described above, conventionally, when heat sterilization using high-pressure steam, heat sterilization gas, etc. was performed with the medical sheath pressed by the holding portion of the mount, the medical sheath sometimes deformed. On the other hand, according to the medical device according to the embodiment, since at least a part of the first fixing member is disposed in the lumen of the medical sheath, the lumen side of the medical sheath can be supported, so that deformation of the medical sheath can be reduced.

[0013] Hereinafter, the medical device according to the first embodiment will be described while referring to FIGS. 1, FIGS. 2, and FIGS. 3. FIG. 1 is a plan view of the medical device according to the first embodiment. FIG. 2 is a cross-sectional view showing the A-A cross-section of FIG. 1. FIG. 3 is a plan view of the sheet before arranging the medical sheath of FIG. 1. FIG. 4 is a plan view of an example of the medical sheath.

[0014] As shown in Figures 1 and 2, the medical device 101 according to the first embodiment comprises a base sheet 10, a medical sheath 20, and a first fixing member 1, at least a portion of which is positioned in the lumen 20L of the medical sheath 20 and which detachably fixes the medical sheath 20 to the base sheet 10. Since at least a portion of the first fixing member 1 is positioned in the lumen 20L of the medical sheath 20, the lumen 20L side of the medical sheath 20 can be supported, thereby reducing deformation of the medical sheath 20 due to heat sterilization.

[0015] As shown in Figures 1 and 3, it is preferable that the first fixing member 1 extends linearly in the first direction 1X. This makes it easier for the first fixing member 1 to support the inner lumen 20L side of the medical sheath 20, which extends linearly.

[0016] As shown in Figures 1 and 3, it is preferable that the first fixing member 1 has a first fixing portion 1C that extends in a first direction 1X and is fixed to the base sheet 10 at one end 1A in the first direction 1X. Furthermore, it is preferable that the first fixing member 1 has an unfixed portion 1F that is not fixed to the base sheet 10. By placing at least a part of the unfixed portion 1F of such a first fixing member 1 in the lumen 20L of the medical sheath 20, the medical device 101 can be indirectly and detachably fixed to the base sheet 10.

[0017] In the first fixing portion 1C, it is sufficient that the first fixing member 1 is fixed to the base sheet 10. Examples of fixing methods include the first fixing member 1 being welded to the base sheet 10, being bonded with an adhesive, a bonding agent, etc., and the first fixing member 1 having holes or protrusions that fit together with the base sheet 10 having protrusions or holes.

[0018] The shape of the first fixing part 1C in plan view is not particularly limited, but examples include a circle, an ellipse, a polygon, or a rounded polygon.

[0019] The non-fixed portion 1F of the first fixing member 1 preferably extends linearly in the first direction 1X. This makes it easier for the first fixing member 1 to support the lumen 20L side of the medical sheath 20, which extends linearly.

[0020] As shown in Figure 2, it is preferable that at least a portion of the outer edge of the first fixing member 1 in the first direction 1X is in contact with the inner surface of the medical sheath 20. This makes the medical sheath 20 less prone to deformation.

[0021] As shown in Figure 1, the length of the non-fixed portion 1F of the first fixing member 1 in the first direction 1X is preferably 1.00 times or more and 1.20 times or less the axial length 20X of the medical sheath 20, and more preferably 1.02 times or more and 1.10 times or less. This makes it difficult for the medical sheath 20 to deform overall.

[0022] As shown in Figures 1 and 3, it is preferable that the first fixing member 1 does not have a fixing portion fixed to the base sheet 10 in the region closer to the other end 1B than the first fixing portion 1C in the first direction 1X. This makes it easier to position the non-fixed portion 1F of the first fixing member 1 in the lumen 20L of the medical sheath 20.

[0023] The non-fixed portion 1F of the first fixing member 1 is preferably flap-shaped. This makes the non-fixed portion 1F of the first fixing member 1 easier to move, thus making it easier to attach and detach the medical sheath 20 to the base sheet 10.

[0024] Preferably, the first fixing member 1 has a first widened portion adjacent to the first fixing portion 1C, which widens toward the first fixing portion 1C. Furthermore, preferably, the first fixing member 1 has a first fixed width portion of a constant width adjacent to the first widened portion. For details of the first widened portion and the first fixed width portion, refer to the first widened portion 1D and the first fixed width portion 1E of the medical device 102 according to the second embodiment described later.

[0025] The first fixing member 1 is preferably in the form of a sheet or a rod, and more preferably in the form of a sheet. Being in the form of a sheet allows for easy supply of sterilization gases, such as heat sterilization gases, to the lumen 20L while supporting the inner lumen 20L of the medical sheath 20.

[0026] When the first fixing member 1 is a sheet, the shape of the outer edge of the sheet in plan view is preferably rectangular, trapezoidal, rounded rectangle, rounded rectangle, or arched, and more preferably rectangular or trapezoidal. This makes it easier for the first fixing member 1 to support the inner lumen 20L side of the medical sheath 20.

[0027] When the first fixing member 1 is a sheet, the outer edge of the sheet extending in the first direction 1X is preferably straight, but may also be non-linear, such as arc-shaped or wavy. The sheet preferably includes a resin layer, a paper layer, or a laminate thereof, and more preferably consists of a resin layer. The laminate may include one or more resin layers and one or more paper layers, or it may include two or more resin layers, or it may include two or more paper layers.

[0028] The resin layers are preferably polyolefin layers, fluororesin layers, polyester layers, polyurethane layers, polystyrene layers, polycarbonate layers, silicone layers, polyamide layers, and polyimide layers, more preferably polyolefin layers and fluororesin layers, and even more preferably polyolefin layers. This makes it easier for the first fixing member 1 to hold the medical sheath 20. Only one of these may be used, or two or more may be used in combination. The polyolefin layer preferably contains polyethylene, polypropylene, or a mixture thereof, more preferably contains polypropylene, and even more preferably consists of polypropylene. The fluororesin layer preferably contains polytetrafluoroethylene. The polyester layer preferably contains polyethylene terephthalate, polybutylene terephthalate, or a mixture thereof. The polyurethane layer preferably contains polyurethane. The polystyrene layer preferably contains polystyrene. The polycarbonate layer preferably contains polycarbonate. The silicone resin layer preferably contains silicone resin. The polyamide layer preferably contains nylon. The polyimide layer preferably contains polyetherimide.

[0029] Preferred paper layers include high-quality paper, medium-quality paper, kraft paper, semi-glossy kraft paper, and latex-impregnated paper. These may be used individually or in combination of two or more types.

[0030] The sheet thickness is preferably 0.1 mm or more and 2.0 mm or less, more preferably 0.15 mm or more and 1.0 mm or less, and even more preferably 0.2 mm or more and 0.8 mm or less. This makes it easier for the first fixing member 1 to support the inner lumen 20L side of the medical sheath 20, and also makes it easier to supply sterilization gas such as heat sterilization gas to the inner lumen 20L.

[0031] When the first fixing member 1 is a rod, the shape of the rod is preferably a cylinder, a polygonal prism, or a rounded polygonal prism, more preferably a polygonal prism, and even more preferably a square prism. This allows the first fixing member 1 to support the inner lumen 20L side of the medical sheath 20 while facilitating the supply of sterilization gas, such as heat sterilization gas, to the inner lumen 20L. The inner lumen may also be formed near the central axis of the rod. In other words, the rod may be hollow. The hollow body may have through holes penetrating from the inner surface to the inner lumen. The rod preferably contains the components listed in the resin layer and / or paper layer above.

[0032] As shown in Figure 2, the width of the portion of the first fixing member 1 positioned in the lumen 20L of the medical sheath 20 is preferably smaller than the diameter of the lumen 20L of the medical sheath 20. This makes it easier to insert and remove the first fixing member 1 into and out of the lumen 20L of the medical sheath 20. The width is preferably 0.95 times or less of the diameter, and more preferably 0.90 times or less of the diameter. On the other hand, the width is preferably 0.70 times or more of the diameter, and more preferably 0.80 times or more of the diameter. Such a first fixing member 1 makes it easier to support the lumen 20L side of the medical sheath 20. The diameter of the lumen is the longest imaginary line segment that passes through the center of the lumen 20L and whose two ends lie on the outer edge of the lumen 20L in a cross-section perpendicular to the axial direction 20X of the medical sheath 20. If the medical sheath 20 has a notch 20S as described later, the outer edge of the notch 20S shall not be included in the outer edge of the lumen 20L.

[0033] The area enclosed by the outer edge of the base sheet 10 in a plan view is 50 cm². 2 More than 1000cm 2 Preferably, it is 300cm 2 More than 600cm 2The following is more preferable: The shape of the base sheet 10 in plan view is preferably circular, elliptical, polygonal, rounded polygonal, or a combination thereof, more preferably polygonal or rounded polygonal, and even more preferably quadrilateral or rounded quadrilateral. If the shape of the base sheet 10 is polygonal or rounded polygonal, the lengths of the imaginary line segments connecting the centroid of the base sheet 10 to each vertex may all be the same, but there may be at least one imaginary line segment that is shorter than the others. The thickness of the base sheet 10 is preferably 0.1 mm or more and 2.0 mm or less, more preferably 0.15 mm or more and 1.0 mm or less, and even more preferably 0.2 mm or more and 0.8 mm or less. This makes the base sheet 10 easier to handle.

[0034] The base sheet 10 preferably includes a resin layer, a paper layer, or a laminate thereof, and more preferably consists of a resin layer. The laminate may include one or more resin layers and one or more paper layers, or it may include two or more resin layers, or it may include two or more paper layers. The base sheet 10 and the first fixing member 1 preferably have the same layers, and more preferably consist of the same layers. For the resin layer and the paper layer, refer to the description of the sheet of the first fixing member 1 described above.

[0035] The base sheet 10, although not shown in the figures, may have a notch extending in a first direction 1X in the portion where the medical sheath 20 is placed. The shape of the notch is preferably linear. The notch allows for pressure relief or movement of at least a portion of the medical sheath 20 downwards when pressure is applied to the medical sheath 20, thus making the medical sheath 20 less prone to deformation. This makes it easier to stack multiple medical devices 101 for sterilization. The length of the notch in the first direction 1X is preferably 0.5 times or more, more preferably 0.8 times or more, even more preferably 0.9 times or more, and most preferably 1.0 times the length of the non-fixed portion 1F in the first direction 1X. The width of the notch is preferably greater than or equal to the width of the non-fixed portion 1F and smaller than the outer diameter of the medical sheath 20. This makes it easier to achieve the pressure relief effect and makes it easier for the base sheet 10 to support the medical sheath 20.

[0036] As shown in Figure 1, the medical sheath 20 is preferably a tube extending in the axial direction 20X. The medical sheath 20 is preferably used to facilitate the insertion of a treatment catheter, such as a balloon catheter, microcatheter, or penetrating catheter, into a guiding catheter that has been previously inserted into the body. The axial length 20X of the medical sheath 20 is preferably 4 cm or more and 40 cm or less, more preferably 6 cm or more and 20 cm or less, and even more preferably 8 cm or more and 18 cm or less. The inner diameter of the medical sheath 20 is preferably 0.2 mm or more and 4.0 mm or less, more preferably 0.5 mm or more and 2.5 mm or less, and even more preferably 1.0 mm or more and 2.0 mm or less. The outer diameter of the medical sheath 20 is preferably 1.01 times or more and 2.00 times or less than the inner diameter, more preferably 1.02 times or more and 1.50 times or less, and even more preferably 1.05 times or more and 1.30 times or less.

[0037] As shown in Figure 4, it is preferable that the medical sheath 20 has a notch 20S extending in the axial direction 20X. Depending on the treatment site, when inserting a treatment catheter such as a balloon catheter into the body, the distal end of the sheath may be inserted into the proximal end of the guiding catheter, and the treatment catheter may be inserted into the guiding catheter through the sheath. In such cases, it is necessary to remove the sheath from the treatment catheter after insertion, but because the medical sheath 20 has a notch 20S, the medical sheath 20 can be removed by opening the notch 20S. Furthermore, the notch 20S makes it easier to attach and detach the medical sheath 20 to the base sheet 10.

[0038] As shown in Figure 4, the medical sheath 20 preferably has an opening 20O that widens from the distal end to the proximal end, and an outer surface at the proximal end. This configuration is known as a flared shape, and a catheter for treatment, such as a balloon catheter, can be easily inserted through the opening 20O.

[0039] The medical sheath 20 preferably contains a resin, and more preferably is made of a resin. Examples of resins include polyolefin resins such as polypropylene and polyethylene, polyester resins such as polyethylene terephthalate, polyamide resins such as nylon, aromatic polyether ketone resins such as polyether ether ketone, polyimide resins, fluororesins such as polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, and ethylene-tetrafluoroethylene copolymer. These may be used individually or in combination of two or more types. The shape of the outer edge of the cross-section of the medical sheath 20 in the direction perpendicular to the axial direction 20X of the medical sheath 20 is preferably circular or elliptical, and more preferably circular. Similarly, the shape of the outer edge of the lumen 20L of the cross-section of the medical sheath 20 in the direction perpendicular to the axial direction 20X of the medical sheath 20 is preferably circular or elliptical, and more preferably circular.

[0040] Although not shown in the diagram, the medical device 101 may further have a packaging bag containing the sheet 10, the medical sheath 20, and the first fixing member 1. This makes it easier to maintain the sterile state of the medical sheath 20 and other components after sterilization. Examples of sterilization treatments include high-pressure steam sterilization and ethylene oxide gas sterilization.

[0041] The medical device according to the second embodiment will be described below with reference to Figures 5 and 6. Figure 5 is a plan view of the medical device according to the second embodiment. Figure 6 is a plan view of the sheet before the medical sheath shown in Figure 5 is placed on it. Detailed explanations of the parts of the medical device according to the second embodiment that overlap with the medical device according to the first embodiment will be omitted.

[0042] As shown in Figures 5 and 6, the medical device 102 according to the second embodiment includes a base sheet 10, a medical sheath 20, and a first fixing member 1, at least a portion of which is positioned in the lumen 20L of the medical sheath 20 and detachably fixes the medical sheath 20 to the base sheet 10. Preferably, the first fixing member 1 extends in a first direction 1X and has a first fixing portion 1C fixed to the base sheet 10 at one end 1A in the first direction 1X.

[0043] As shown in Figures 5 and 6, the medical device 102 further has a second fixing member 2 that extends in a second direction 2X and at least a portion of which is positioned in the lumen 20L of the medical sheath 20, and which detachably fixes the medical sheath 20 to the base sheet 10. The second fixing member 2 has a second fixing portion 2C which is fixed to the base sheet 10 at one end 2A in the second direction 2X, and it is preferable that the other end 2B of the second fixing member 2 in the second direction 2X faces the other end 1B of the first fixing member 1 in the first direction 1X. With the first fixing member 1 and the second fixing member 2 facing each other in this way, the medical sheath 20 can be indirectly fixed to the base sheet 10 from both sides in the axial direction 20X, making it difficult for the medical sheath 20 to move in the axial direction 20X.

[0044] The first fixing member 1 and the second fixing member 2 each have non-fixed portions 1F and 2F that are not fixed to the base sheet 10, and it is preferable that at least a portion of each of the non-fixed portions 1F and 2F is located in the lumen 20L of the medical sheath 20. Since the non-fixed portion 1F of the first fixing member 1 and the non-fixed portion 2F of the second fixing member 2 can be moved independently, the medical sheath 20 can be easily attached to and detached from the base sheet 10.

[0045] The non-fixed portion 1F of the first fixing member 1 and the non-fixed portion 2F of the second fixing member 2 are preferably flap-shaped. Since the non-fixed portion 1F of the first fixing member 1 and the non-fixed portion 2F of the second fixing member 2 can be moved independently, the medical sheath 20 can be easily attached to and detached from the base sheet 10.

[0046] As shown in Figures 5 and 6, it is preferable that the first fixing member 1 does not have a fixing portion fixed to the base sheet 10 in the region closer to the other end 1B than the first fixing portion 1C in the first direction 1X, and that the second fixing member 2 does not have a fixing portion fixed to the base sheet 10 in the region closer to the other end 2B than the second fixing portion 2C in the second direction 2X. In such a configuration, the non-fixed portion 1F of the first fixing member 1 and the non-fixed portion 2F of the second fixing member 2 can be moved independently, making it easier to attach and detach the medical sheath 20 to the base sheet 10.

[0047] As shown in Figure 6, it is preferable that the first direction 1X and the second direction 2X are parallel. This makes it easier for the first fixing member 1 extending in the first direction 1X and the second fixing member 2 extending in the second direction 2X to support the entire lumen 20L side of the medical sheath 20. Parallel means that the angle between the first direction 1X and the second direction 2X is 5 degrees or less. More preferably, this angle is 3 degrees or less, even more preferably 2 degrees or less, and most preferably 0 degrees.

[0048] As shown in Figures 5 and 6, it is preferable that the first fixing member 1 has a first widened portion 1D adjacent to the first fixing portion 1C, which widens toward the first fixing portion 1C, and the second fixing member 2 has a second widened portion 2D adjacent to the second fixing portion 2C, which widens toward the second fixing portion 2C. The first widened portion 1D and the second widened portion 2D can alleviate the force applied to both ends of the medical sheath 20 in the axial direction 20X, thereby making both ends of the medical sheath 20 less susceptible to damage. This also makes it more difficult for the medical sheath 20 to move in the axial direction 20X. It is preferable that the first widened portion 1D is located on the other end 1B side of the first fixing portion 1C in the first direction 1X. Furthermore, it is preferable that the second widened portion 2D is located on the other end 2B side of the second fixing portion 2C in the second direction 2X. It is preferable that the outer edges of the first widened portion 1D and the second widened portion 2D are straight. This allows the first widening section 1D and the second widening section 2D to be tapered, making both ends of the medical sheath 20 even less susceptible to damage. The outer edges of the first widening section 1D and the second widening section 2D may be non-linear, such as arc-shaped or wavy.

[0049] As shown in Figures 5 and 6, it is preferable that the first fixing member 1 has a first fixed width portion 1E of a fixed width in the portion adjacent to the first widening portion 1D, and the second fixing member 2 has a second fixed width portion 2E of a fixed width in the portion adjacent to the second widening portion 2D. This makes it easier for the first fixing member 1 and the second fixing member 2 to support the entire inner lumen 20L side of the medical sheath 20. It is preferable that the first fixed width portion 1E is located on the other end 1B side of the first widening portion 1D in the first direction 1X. Furthermore, it is preferable that the second fixed width portion 2E is located on the other end 2B side of the second widening portion 2D in the second direction 2X. It is preferable that the first fixed width portion 1E extends in the first direction 1X. Furthermore, it is preferable that the second widening portion 2D extends in the second direction 2X.

[0050] As shown in Figures 5 and 6, it is preferable that the length of the unfixed portion 1F of the first fixing member 1 in the first direction 1X is longer than the length of the unfixed portion 2F of the second fixing member 2 in the second direction 2X. This allows, for example, the unfixed portion 1F of the first fixing member 1 and the unfixed portion 2F of the second fixing member 2 to be inserted into the lumen 20L of the medical sheath 20 and sterilized by heat, and then the unfixed portion 2F of the second fixing member 2, which has a shorter length in the extending direction, to be removed first, thereby allowing the unfixed portion 1F of the first fixing member 1, which has a longer length in the extending direction, to be removed smoothly. Furthermore, in the case of the medical sheath 20 shown in Figure 4, it is preferable that the unfixed portion 2F of the second fixing member 2, which has a shorter length in the extending direction, is inserted into the opening 20O side, and the unfixed portion 1F of the first fixing member 1, which has a longer length in the extending direction, is inserted into the opening on the opposite side of the opening 20O. This makes it easier to remove the medical sheath 20 from the base sheet 10.

[0051] The length of the unfixed portion 1F of the first fixing member 1 in the first direction 1X is preferably 1.1 times or more and 2.0 times or less, more preferably 1.2 times or more and 1.8 times or less, and even more preferably 1.3 times or more and 1.5 times or less, than the length of the unfixed portion 2F of the second fixing member 2 in the second direction 2X. This makes it possible to achieve both stable fixation of the medical sheath 20 and ease of attachment and detachment.

[0052] As shown in Figures 5 and 6, it is preferable that the first fixing member 1 and the second fixing member 2 are not in contact. This makes it easier to avoid pressure from the lumen 20L of the medical sheath 20 that occurs when, for example, the tip of the first fixing member 1 and the tip of the second fixing member 2 come into contact when the base sheet 10 is curved overall.

[0053] The shortest distance between the first fixing member 1 and the second fixing member 2 is preferably longer than the thickness of the first fixing member 1 or the thickness of the second fixing member 2. This makes it less likely for the tip of the first fixing member 1 and the tip of the second fixing member 2 to come into contact when the base sheet 10 is curved overall. The shortest distance between the first fixing member 1 and the second fixing member 2 is more preferably 1.5 times or more the thickness of the first fixing member 1 or the thickness of the second fixing member 2. On the other hand, the shortest distance between the first fixing member 1 and the second fixing member 2 is preferably 10 times or less the thickness of the first fixing member 1 or the thickness of the second fixing member 2, and more preferably 5 times or less the thickness of the first fixing member 1 or the thickness of the second fixing member 2. This makes it easier for the first fixing member 1 and the second fixing member 2 to support the entire inner lumen 20L side of the medical sheath 20.

[0054] For further details of the first fixing member 1, please refer to the description of the first fixing member 1 of the medical device 101 according to the first embodiment. The second fixing member 2 will be described in detail below.

[0055] In the second fixing portion 2C, it is sufficient that the second fixing member 2 is fixed to the base sheet 10. Examples of fixing methods include the second fixing member 2 being welded to the base sheet 10, being bonded with an adhesive, a bonding agent, etc., and the hole or protrusion provided in the second fixing member 2 being fitted with the protrusion or hole provided in the base sheet 10.

[0056] The shape of the second fixing part 2C in plan view is not particularly limited, but examples include a circle, an ellipse, a polygon, or a rounded polygon.

[0057] The non-fixed portion 2F of the second fixing member 2 preferably extends linearly in the second direction 2X. This makes it easier for the second fixing member 2 to support the lumen 20L side of the medical sheath 20, which extends linearly.

[0058] Preferably, at least a portion of the outer edge of the second fixing member 2 in the second direction 2X is in contact with the inner surface of the medical sheath 20. This makes the medical sheath 20 less prone to deformation.

[0059] The width of the portion of the second fixing member 2 positioned in the lumen 20L of the medical sheath 20 is preferably smaller than the diameter of the lumen 20L of the medical sheath 20. This makes it easier to insert and remove the second fixing member 2 into and out of the lumen 20L of the medical sheath 20. The width is preferably 0.95 times or less of the diameter, and more preferably 0.90 times or less of the diameter. On the other hand, the distance is preferably 0.70 times or more of the diameter, and more preferably 0.80 times or more of the diameter. Such a second fixing member 2 makes it easier to support the lumen 20L side of the medical sheath 20.

[0060] The second fixing member 2 is preferably in the form of a sheet or a rod, and more preferably in the form of a sheet. Being in the form of a sheet allows for easier supply of sterilization gases, such as heat sterilization gases, to the lumen 20L while supporting the inner lumen 20L of the medical sheath 20.

[0061] When the second fixing member 2 is a sheet, the shape of the outer edge of the sheet in plan view is preferably rectangular, trapezoidal, rounded rectangle, rounded rectangle, or arched, and more preferably rectangular or trapezoidal. This makes it easier for the second fixing member 2 to support the inner lumen 20L side of the medical sheath 20.

[0062] If the second fixing member 2 is a sheet extending in the second direction 2X, the outer edge of the sheet in the second direction 2X is preferably straight, but may be non-linear, such as arc-shaped or wavy. The sheet preferably includes a resin layer, a paper layer, or a laminate thereof, and more preferably consists of a resin layer. The laminate may include one or more resin layers and one or more paper layers, or may include two or more resin layers, or two or more paper layers. For details on the resin layer and paper layer, refer to the description of the sheet of the first fixing member 1 above. It is preferable that the first fixing member 1 and the second fixing member 2 have the same layer, and more preferably consist of the same layer. It is also preferable that the first fixing member 1 and the second fixing member 2 are sheets.

[0063] The sheet thickness is preferably 0.1 mm or more and 2.0 mm or less, more preferably 0.15 mm or more and 1.0 mm or less, and even more preferably 0.2 mm or more and 0.8 mm or less. This makes it easier for the second fixing member 2 to support the inner lumen 20L side of the medical sheath 20, and also makes it easier to supply sterilization gas such as heat sterilization gas to the inner lumen 20L.

[0064] When the second fixing member 2 is a rod, the shape of the rod is preferably cylindrical, polygonal prism, or rounded polygonal prism, more preferably polygonal prism, and even more preferably square prism. This allows the second fixing member 2 to support the lumen 20L side of the medical sheath 20 while facilitating the supply of sterilization gas, such as heat sterilization gas, to the lumen 20L. The lumen may also be formed near the central axis of the rod. In other words, the rod may be hollow. The hollow body may have through holes penetrating from the inner surface to the lumen. The rod preferably contains the components listed in the resin layer and / or paper layer above.

[0065] The base sheet 10, although not shown, may have a notch in the portion where the medical sheath 20 is placed. The shape of the notch is preferably linear. The notch allows for the relief of pressure when pressure is applied to the medical sheath 20, or allows at least a portion of the medical sheath 20 to be moved downward, making the medical sheath 20 less prone to deformation. This makes it easier to stack multiple medical devices 102 and sterilize them. The length of the notch in the extending direction is preferably 0.5 times or more, more preferably 0.8 times or more, even more preferably 0.9 times or more, and even more preferably 1.0 times or more, which is the sum of the length of the first direction 1X of the non-fixed portion 1F and the length of the second direction 2X of the non-fixed portion 2F. On the other hand, this ratio may be 1.2 times or less, or 1.1 times or less. The width of the notch is preferably greater than or equal to the width of the non-fixed portion 1F, greater than or equal to the width of the non-fixed portion 2F, and smaller than the outer diameter of the medical sheath 20. This makes it easier for the above-mentioned pressure relief effect to be achieved, and also makes it easier for the base sheet 10 to support the medical sheath 20.

[0066] The medical device according to the third embodiment will be described below with reference to Figures 7, 8, 9, and 10. Figure 7 is a plan view of the medical device according to the third embodiment. Figure 8 is a cross-sectional view showing the BB cross section of Figure 7. Figure 9 is a plan view of the sheet before the medical sheath of Figure 7 is placed on it. Figure 10 is a cross-sectional view showing a modified example of the BB cross section of Figure 8. Note that detailed explanations of the parts of the medical device according to the third embodiment that overlap with the medical device according to the first embodiment and the medical device according to the second embodiment will be omitted.

[0067] As shown in Figures 7 and 8, the medical device 103 according to the third embodiment includes a base sheet 10, a medical sheath 20, and a first fixing member 1, at least a portion of which is positioned in the lumen 20L of the medical sheath 20 and detachably fixes the medical sheath 20 to the base sheet 10. Preferably, the first fixing member 1 extends in a first direction 1X and has a first fixing portion 1C that is fixed to the base sheet 10 at one end 1A in the first direction 1X.

[0068] Preferably, the first fixing member 1 has a second fixing portion 2C fixed to the base sheet 10 at the other end of the first fixing member 1 in a first direction 1X. This allows the non-fixed portion 1F between the first fixing portion 1C and the second fixing portion 2C of the first fixing member 1 to float like a bridge, so that the non-fixed portion 1F can be inserted into or removed from the lumen 20L through the notch 20S of the medical sheath 20. For this reason, it is preferable that the first fixing member 1 does not have any other fixing portion between the first fixing portion 1C and the second fixing portion 2C.

[0069] The length of the non-fixed portion 1F in the first direction 1X is preferably 1.01 times or more and 1.20 times or less the axial length 20X of the medical sheath 20, and more preferably 1.02 times or more and 1.10 times or less. This makes it possible to suppress the axial movement 20X of the medical sheath 20 while making it easier to avoid damage to both ends of the medical sheath 20.

[0070] As shown in Figure 10, at least a portion of the first fixing member 1 may be sandwiched between the notches 20S of the medical sheath 20. This makes it easier to prevent deformation such as one of the notch edges of the notch 20S of the medical sheath 20 moving inward compared to the other notch edge when vertical pressure is applied to the medical sheath 20.

[0071] Although not shown, the base sheet 10 may have a notch extending in the first direction 1X in the portion where the first fixing member 1 is placed. This notch allows for pressure relief or movement of at least a portion of the medical sheath 20 downwards when pressure is applied to the medical sheath 20, thereby making the medical sheath 20 less prone to deformation. This makes it easier to stack multiple medical devices 103 and sterilize them. For details of the notch, refer to the description of the notch of the medical device 101 according to the first embodiment.

[0072] Although not shown, the first fixing member 1 preferably has a first widened portion adjacent to the first fixing portion 1C, which widens toward the first fixing portion 1C. Furthermore, the first fixing member 1 preferably has a first fixed width portion of a constant width adjacent to the first widened portion. Furthermore, the first fixing member 1 preferably has a second widened portion adjacent to the second fixing portion 2C, which widens toward the second fixing portion 2C. For details of the first widened portion, the first fixed width portion, and the second widened portion, refer to the first widened portion 1D, the first fixed width portion 1E, and the second widened portion 2D of the medical device 102 according to the second embodiment.

[0073] Although not shown in the diagram, each medical device 101, 102, and 103 has a medical tubular body and a protective tube in which at least a portion of the medical tubular body is placed inside, the base sheet 10 has a pair of notches, the edges of the notches each hold the wound protective tube, and preferably at least the first fixing member 1 is located outside the region from one of the pair of notches to the other. Because each medical device 101, 102, and 103 has a medical sheath 20, a protective tube, and a medical tubular body, the medical sheath 20, the protective tube, and the medical tubular body can be sterilized together. Furthermore, since the region from one notch to the other is easily deformed when attaching and detaching the protective tube, positioning the medical sheath 20 outside this region makes it easier to prevent the medical sheath 20 from detaching at an unintended time. Conversely, it also makes it easier to prevent the protective tube from detaching at unintended times when attaching or detaching the medical sheath 20.

[0074] Preferably, the pair of flaps formed by the pair of cuts extend outward from the base sheet 10. This makes it easier for each flap to hold the wound protective tube.

[0075] The medical sheath 20 is preferably located inside the wound protective tube. This arrangement reduces the pressure on the medical sheath 20 when medical devices are stacked.

[0076] The base sheet 10 may have other notches. The medical devices 101, 102, and 103 may also have other components, which may be fixed to the base sheet 10 by the notched edges of one or more other notches. Examples of other components include syringes, mandrels, guidewires, needles, dilators, inserters, and re-wrappers.

[0077] The outer edge shape of the cross-section in the thickness direction of the protective tube is preferably circular, elliptical, polygonal, rounded polygonal, or a combination thereof, more preferably circular, elliptical, or rounded polygonal, even more preferably circular or elliptical, and even more preferably circular. The outer edge shape of the inner lumen of the cross-section in the thickness direction of the protective tube is preferably circular, elliptical, polygonal, rounded polygonal, or a combination thereof, more preferably circular, elliptical, or rounded polygonal, even more preferably circular or elliptical, and even more preferably circular. The protective tube may contain polyethylene, polypropylene, polyolefin resins such as ethylene-propylene copolymer and ethylene-vinyl acetate copolymer, polyvinyl chloride resin, polystyrene resin, polyamide resin, polyimide resin, or mixtures thereof.

[0078] The outer diameter of the protective tube in the thickness direction is preferably larger than the outer diameter of the medical sheath 20. This makes the medical sheath 20 less likely to deform when multiple medical devices are stacked.

[0079] The medical tubular body is preferably a balloon catheter, a microcatheter, or a penetrating catheter, and more preferably a balloon catheter. The medical tubular body also preferably has a handle at its proximal end. The protective tube only needs to be capable of holding at least a portion of the medical tubular body inside. The protective tube is preferably secured in a wound state by multiple clips. [Explanation of Symbols]

[0080] 1. First fixing member 1X 1st direction 1A One end 1B Other end 1C 1st fixed part 1D First widening section 1E 1st constant width section 1F non-fixed area 2. Second fixing member 2X 2nd direction 2A One end 2B Other end 2C 2nd fixed part 2D Second widening section 2E 2nd constant width section 2F Non-fixed area 10 Base sheet 20 Medical Sheaths 20L lumen 20O opening 20X Axial 20S cut 101, 102, 103 Medical devices

Claims

1. A base sheet comprising a resin layer and / or a paper layer, Medical sheath and, A medical device comprising a first fixing member, at least a portion of which is disposed within the lumen of the medical sheath and which detachably fixes the medical sheath to the base sheet.

2. The medical device according to claim 1, wherein the first fixing member extends in a first direction and has a first fixing portion fixed to the base sheet at one end in the first direction.

3. Furthermore, it has a second fixing member that extends in a second direction and at least a portion of which is positioned in the lumen of the medical sheath and detachably fixes the medical sheath to the base sheet, and the second fixing member has a second fixing portion that is fixed to the base sheet at one end in the second direction. The medical device according to claim 2, wherein the other end of the second fixing member in the second direction faces the other end of the first fixing member in the first direction.

4. The first fixing member has a first widened portion adjacent to the first fixing portion, which widens toward the first fixing portion. The medical device according to claim 3, wherein the second fixing member has a second widening portion adjacent to the second fixing portion, which widens toward the second fixing portion.

5. The first fixing member has a first fixed-width portion of a certain width in the portion adjacent to the first widening portion, The medical device according to claim 4, wherein the second fixing member has a second fixed width portion of a certain width in the portion adjacent to the second widening portion.

6. The medical device according to claim 3 or 4, wherein the first fixing member and the second fixing member each have an unfixed portion that is not fixed to the base sheet, and at least a portion of each of the unfixed portions is disposed in the lumen of the medical sheath.

7. The medical device according to claim 6, wherein the length of the unfixed portion of the first fixing member in the first direction is longer than the length of the unfixed portion of the second fixing member in the second direction.

8. The medical device according to claim 6, wherein the non-fixed portion of the first fixing member and the non-fixed portion of the second fixing member are each flap-shaped.

9. The medical device according to claim 3 or 4, wherein the first fixing member and the second fixing member are not in contact.

10. The medical device according to claim 2, wherein the first fixing member has a second fixing portion fixed to the base sheet at the other end of the first fixing member in the first direction.

11. The medical device according to claim 1 or 2, wherein the width of the portion of the first fixing member that is positioned in the lumen of the medical sheath is smaller than the diameter of the lumen of the medical sheath.

12. The medical device according to claim 3 or 4, wherein the width of the portion of the second fixing member that is positioned in the lumen of the medical sheath is smaller than the diameter of the lumen of the medical sheath.

13. The medical device according to claim 1 or 2, wherein the first fixing member is in the form of a sheet.

14. The medical device according to claim 3 or 4, wherein the second fixing member is in the form of a sheet.

15. The medical device according to claim 1 or 2, wherein the medical sheath has an axially extending notch.

16. The medical device according to claim 15, wherein at least a portion of the first fixing member is sandwiched between the notches of the medical sheath.

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