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 sheet with a first cut and a medical sheath. A cutting edge of the first cut is at least partially disposed in the lumen of the medical sheath.SELECTED DRAWING: Figure 7

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, flexible medical devices such as catheters have often been fixed to a backing sheet and packaged in a bag when in an unused state. For example, Patent Document 1 discloses a medical device holding backing sheet made of a long sheet material that is housed 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 housing 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 also 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 one or more restraining pieces, a cut having an arch-shaped one end portion is provided at substantially the central portion of the restraining piece, the restraining piece is cut from the arch-shaped end portion of the cut to the end portion of the restraining piece to form a pressure-relieving portion, and the restraining piece is bent at the 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 sheet having a first cut and a medical sheath, A medical device in which at least a portion of the cut edge of the first cut is positioned within the lumen of a medical sheath.

[0006] As described above, since at least a portion of the cut edge of the first notch in the sheet is positioned within the lumen of the medical sheath, the lumen side of the medical sheath is supported by a portion of the sheet, making the medical sheath less prone to deformation.

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

[15] . [2] The first cut has a portion A1 that extends in the first direction, The medical device according to [1], wherein the sheet has a second notch, the second notch having a portion B1 that extends in a second direction and faces the portion A1 in the width direction. [3] The medical device as described in [2], wherein the portion A1 and the portion B1 are each linear. [4] The medical device according to [2] or [3], wherein the first direction and the second direction are parallel. [5] The first cut has a portion A2 adjacent to one end of the portion A1 in the first direction, The second cut has a portion B2 adjacent to one end of portion B1 in the second direction, and one end of portion B1 is closer to one end of portion A1 than the other end of portion A1 in the first direction. The medical device according to any one of [2] to [4], wherein the portion A2 and the portion B2 extend away from each other from one end of the portion A1 and the one end of the portion B1. [6] The first cut has a portion A3 adjacent to the other end of the portion A1 in the first direction, The second cut has a portion B3 adjacent to the other end of the portion B1 in the second direction. The medical device as described in [5], wherein the portion A3 and the portion B3 extend away from each other from the other end of the portion A1 and the other end of the portion B1. [7] The portion A1 is longer than the portion A2 and longer than the portion A3, The medical device according to [6], wherein portion B1 is longer than portion B2 and longer than portion B3. [8] In the portion of the sheet that is positioned in the lumen of the medical sheath, the distance from portion A1 to portion B1 in a direction perpendicular to the axial direction of the medical sheath is shorter than the diameter of the lumen of the medical sheath, as described in any of [2] to [7]. [9] The medical sheath is a medical device according to any one of [1] to [8], having an axially extending notch.

[10] The medical device according to any one of [2] to [9], wherein the sheet has a third cut passing through one point in the portion A1 excluding both ends of the portion A1 and one point in the portion B1 excluding both ends of the portion B1.

[11] The medical device according to

[10] , wherein the third notch is located on the side closer to one end of the portion A1 in the first direction and on the side closer to one end of the portion B1 in the second direction.

[12] The medical device according to

[10] or

[11] , wherein the width of the third incision is greater than the width of the first incision.

[13] The portion A1 is shorter than the portion A2 and also shorter than the portion A3, The medical device according to [6], wherein the portion B1 is shorter than the portion B2 and also shorter than the portion B3.

[14] In the portion disposed in the lumen of the medical sheath of the sheet, The distance from the portion A2 to the portion A3 in the direction perpendicular to the axial direction of the medical sheath is shorter than the diameter of the lumen of the medical sheath, and The medical device according to

[13] , wherein the distance from the portion B2 to the portion B3 in the direction perpendicular to the axial direction of the medical sheath is shorter than the diameter of the lumen of the medical sheath.

[15] Further, it has a medical tubular body and a protective tube in which at least a part of the medical tubular body is disposed inside, The sheet has a pair of cuts, and the cut edges of the pair of cuts sandwich the wound protective tube respectively, The first cut and the second cut are located outside the region from one cut of the pair of cuts to the other cut, and the medical device according to any one of [2] to

[14] .

Advantages of the Invention

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

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 an example of a medical sheath. [Figure 4] Fig. 4 is a plan view of a medical device according to the second embodiment. [Figure 5] Fig. 5 is a cross-sectional view showing the B-B cross-section of Fig. 4. [Figure 6]FIG. 6 is a plan view of the sheet before arranging the medical sheath of FIG. 4. [Figure 7] FIG. 7 is a plan view of a medical instrument according to a third embodiment. [Figure 8] FIG. 8 is a cross-sectional view showing a C-C 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 plan view of a modified example of the sheet of FIG. 9. [Figure 11] FIG. 11 is a plan view of a medical instrument according to a fourth embodiment. [Figure 12] FIG. 12 is a plan view of a medical instrument according to a fifth embodiment.

MODE 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 range 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, component symbols and the like may be omitted, but in such a case, 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 understanding of the features of the present invention.

[0011] The medical instrument according to the embodiment of the present invention has a sheet having a first cut and a medical sheath, and at least a part of the cut edge of the first cut is disposed in the lumen of the medical sheath.

[0012] As described above, conventionally, when a medical sheath is pressed down by the holding portion of the backing sheet and heat sterilization is performed using high-pressure steam or heat sterilization gas, the medical sheath may deform. In contrast, with the medical device according to the embodiment, the inner lumen side of the medical sheath can be supported by the cut edge of the first cut in the sheet, thereby reducing deformation of the medical sheath.

[0013] The following describes a medical device according to the first embodiment with reference to Figures 1, 2, and 3. Figure 1 is a plan view of the medical device according to the first embodiment, and Figure 2 is a cross-sectional view showing section AA of Figure 1. Figure 3 is a plan view of an example of a medical sheath.

[0014] As shown in Figures 1 and 2, the medical device 101 according to the first embodiment comprises a sheet 10 having a first notch 1S and a medical sheath 20, wherein at least a portion of the notch edge 1Ea of the first notch 1S is positioned in the lumen 20L of the medical sheath 20. The notch edge 1Ea of the first notch 1S of the sheet 10 and the surrounding area can support the lumen 20L side of the medical sheath 20. As a result, deformation of the medical sheath 20 due to heat sterilization can be reduced.

[0015] As shown in Figure 1, the first notch 1S preferably has a portion A1(SA1) extending in the first direction 1X. The portion A1(SA1) is preferably linear. This makes it easier for the notch edge 1Ea of the first notch 1S of the sheet 10 and the surrounding area to support the inner lumen 20L side of the linearly extending medical sheath 20. Alternatively, the first notch 1S may consist of a portion A1(SA1) extending in the first direction 1X.

[0016] The portion A1(SA1) of the first cut 1S may be a non-linear cut, such as an arc or a wave. In the case of a non-linear cut, it is preferable that the portion A1(SA1) is located within a region from a virtual line segment connecting both ends of the portion A1(SA1) to a position at a predetermined distance in a direction perpendicular to the virtual line segment. This corresponds, for example, to the case where the portion A1(SA1) is a wave extending in the first direction 1X, that the amplitude of the wave is less than or equal to the predetermined distance. The predetermined distance is preferably 1 / 2 or less of the diameter of the lumen 20L of the medical sheath 20, more preferably 1 / 4 or less, and even more preferably 1 / 10 or less. This makes the non-linear portion A1(SA1) nearly linear. On the other hand, the predetermined distance may be 1 / 100 or more of the diameter of the lumen 20L of the medical sheath 20, 1 / 50 or more, or 1 / 20 or more. The diameter of the lumen 20L of the medical sheath 20 is defined as 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, the outer edge of the notch 20S is not included in the outer edge of the lumen 20L.

[0017] As shown in Figure 2, of the two notches 1Ea and 1Eb of the first notch 1S, it is preferable that one notch edge 1Ea is located in the lumen 20L of the medical sheath 20, and the other notch edge 1Eb is located outside the medical sheath 20. This allows the sheet 10 to support the medical sheath 20 from both the inside and outside, making it difficult for the medical sheath 20 to move.

[0018] Preferably, one edge 1Ea of the first notch 1S is in contact with the inner surface of the medical sheath 20. This makes the medical sheath 20 less prone to deformation. Furthermore, preferably, the other edge 1Eb of the first notch 1S is in contact with the outer surface of the medical sheath 20. This makes the medical sheath 20 less prone to movement.

[0019] As shown in Figure 1, it is preferable that the first notch 1S has a portion A1(SA1) extending in the first direction 1X, a portion A2(SA2) adjacent to one end SA1a of portion A1(SA1) in the first direction 1X, and a portion A3(SA3) adjacent to the other end SA1b. Furthermore, it is preferable that portions A2(SA2) and A3(SA3) extend away from each other as they move in a direction perpendicular to the imaginary line segment connecting the two ends SA1a and SA1b. Since a tapered flap 10F can be formed by such portions A1(SA1), A2(SA2), and A3(SA3), the medical sheath 20 can be easily attached and detached.

[0020] Parts A2(SA2) and B2(SB2) are preferably linear. Parts A2(SA2) and B2(SB2) may also be non-linear cuts. For details on non-linear cuts, refer to the description of the non-linear cuts in part A1(SA1).

[0021] The inclination angle of part A2(SA2) with respect to part A1(SA1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. On the other hand, the inclination angle is preferably 90 degrees or less, more preferably 45 degrees or less, and even more preferably 30 degrees or less. This inclination angle is the inclination angle of the imaginary line segment connecting the ends of part A2(SA2) with respect to the imaginary line segment connecting the ends of part A1(SA1).

[0022] The inclination angle of portion A3(SA3) with respect to portion A1(SA1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. On the other hand, the inclination angle is preferably 90 degrees or less, more preferably 45 degrees or less, and even more preferably 30 degrees or less. This inclination angle is the inclination angle of the imaginary line segment connecting the ends of portion A3(SA3) with respect to the imaginary line segment connecting the ends of portion A1(SA1).

[0023] The sheet 10 preferably comprises a resin layer, a paper layer, or a laminate thereof, and more preferably consists of a resin layer. The laminate may contain one or more resin layers and one or more paper layers, or it may contain two or more resin layers, or it may contain two or more paper layers.

[0024] The resin layers are preferably polyolefin layers, fluororesin layers, polyester layers, polyurethane layers, polystyrene layers, polycarbonate layers, silicone layers, polyamide layers, and polyimide layers, with polyolefin layers and fluororesin layers being more preferred, and polyolefin layers being even more preferred. This makes it easier for the medical sheath 20 to be held by a portion of the sheet 10. These may be used individually, 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.

[0025] 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.

[0026] The thickness of the 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 allows for easy supply of sterilization gases, such as heat sterilization gases, to the lumen 20L while supporting the lumen 20L of the medical sheath 20. The area of ​​the region enclosed by the outer edge of the sheet 10 in a plan view is 50 cm². 2 More than 1000cm 2 Preferably, it is 300cm 2 More than 600cm 2 The following is more preferable: The shape of 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 sheet 10 is polygonal or rounded polygonal, the lengths of the imaginary line segments connecting the centroid of 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.

[0027] 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.

[0028] The medical sheath 20 preferably 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 sheet 10. Also, for example, the medical sheath 20 can be removed from the sheet 10 by pinching and lifting it with the thumb and index finger, and the medical sheath does not get caught on the holding part of the holding base as in the conventional example, which is preferable from the viewpoint of usability.

[0029] As shown in Figure 3, 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.

[0030] 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.

[0031] Although not shown in the diagram, the medical device 101 may further have a packaging bag that encloses the sheet 10 and the medical sheath 20. This makes it easier to maintain the sterile state of the medical sheath 20 and the like after sterilization. Examples of sterilization treatments include high-pressure steam sterilization and ethylene oxide gas sterilization.

[0032] The medical device according to the second embodiment will be described below with reference to Figures 4, 5, and 6. Figure 4 is a plan view of the medical device according to the second embodiment. Figure 5 is a cross-sectional view showing the BB cross section of Figure 4. Figure 6 is a plan view of the sheet before the medical sheath of Figure 4 is placed on it. Note that detailed explanations of parts of the medical device according to the second embodiment that overlap with the medical device according to the first embodiment will be omitted.

[0033] As shown in Figures 4 and 5, the medical device 102 according to the second embodiment comprises a sheet 10 having a first notch 1S and a medical sheath 20, wherein at least a portion of the notch edge 1Ea of the first notch 1S is positioned in the lumen 20L of the medical sheath 20.

[0034] As shown in Figures 4 and 6, the first notch 1S has a portion A1 (SA1) extending in the first direction 1X, and the sheet 10 has a second notch 2S, preferably the second notch 2S has a portion B1 (SB1) extending in the second direction 2X and facing portion A1 (SA1) in the width direction. This forms a bridge portion 13 of the sheet 10 between portion A1 (SA1) and portion B1 (SB1), and the bridge portion 13 can support the inner lumen 20L side of the medical sheath 20. Furthermore, as shown in Figure 5, since the sheet 10 has a hole 14 that follows the shape of the bridge portion 13, even if pressure is applied to the medical sheath 20 from above, at least a part of the medical sheath 20 can move downward, making the medical sheath 20 less prone to deformation. This makes it easier to stack multiple medical devices 102 and sterilize them.

[0035] As shown in Figure 5, of the notch edges 1Ea and 1Eb of the first notch 1S and the notch edges 2Ea and 2Eb of the second notch 2S, it is preferable that the notch edges 1Ea and 2Ea on the bridge portion 13 side are located in the lumen 20L of the medical sheath 20, and the notch edges 1Eb and 2Eb on the side facing the bridge portion 13 are located outside the medical sheath 20. This allows the sheet 10 to support the medical sheath 20 from both the inside and outside, making it difficult for the medical sheath 20 to move.

[0036] It is preferable that the notched edges 1Ea and 2Ea on the bridge portion 13 side, or notched edges 1Ea and 2Ea, are in contact with the inner surface of the medical sheath 20. This makes the medical sheath 20 less prone to deformation. Therefore, it is even more preferable that notched edges 1Ea and 2Ea are in contact with the inner surface of the medical sheath 20.

[0037] It is preferable that the notched edge 1Eb, notched edge 2Eb, or notched edge 1Eb and notched edge 2Eb on the side facing the bridge portion 13 are in contact with the outer surface of the medical sheath 20. This makes it difficult for the medical sheath 20 to move. For this reason, it is more preferable that notched edge 1Eb and notched edge 2Eb are in contact with the outer surface of the medical sheath 20.

[0038] The width of portion A1 (SA1) when the medical sheath 20 is not in place is preferably smaller than the wall thickness of the medical sheath 20. This makes it easier to support the medical sheath 20 with the notch edge 1Ea on one side and the notch edge 1Eb on the other side of the first notch 1S.

[0039] The width of portion B1 (SB1) when the medical sheath 20 is not in place is preferably smaller than the wall thickness of the medical sheath 20. This makes it easier to support the medical sheath 20 with the cut edge 2Ea on one side and the cut edge 2Eb on the other side of the second cut 2S.

[0040] 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 bridge portion 13 between the portion A1 (SA1) extending in the first direction 1X and the portion B1 (SB1) extending in the second direction 2X to support the 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. This angle is more preferably 3 degrees or less, even more preferably 2 degrees or less, and most preferably 0 degrees.

[0041] Parts A1 (SA1) and B1 (SB1) are preferably linear. This makes it easier for the bridge portion 13 to support the lumen 20L side of the medical sheath 20. Parts A1 (SA1) and B1 (SB1) may also be non-linear notches. For details of non-linear notches, please refer to the description of the medical device 101 according to the first embodiment.

[0042] The lengths of section A1 (SA1) and section B1 (SB1) are preferably 1.00 times or more and 1.20 times or less the axial length 20X of the medical sheath 20, and more preferably 1.01 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.

[0043] As shown in Figures 4 and 6, the first notch 1S has a portion A2(SA2) adjacent to one end SA1a of portion A1(SA1) in the first direction 1X, and the second notch 2S has a portion B2(SB2) adjacent to one end SB1a of portion B1(SB1) in the second direction 2X, and it is preferable that one end SB1a of portion B1(SB1) is closer to one end SA1a of portion A1(SA1) than the other end SA1b of portion A1(SA1) in the first direction 1X, and that portion A2(SA2) and portion B2(SB2) extend in directions away from each other from one end SA1a of portion A1(SA1) and one end SB1a of portion B1(SB1). These portions A2 (SA2) and B2 (SB2), which extend in directions away from each other, can alleviate the force acting on the medical sheath 20 near one end SA1a and the other end SB1a, making one end of the medical sheath 20 less susceptible to damage. This also makes it more difficult for the medical sheath 20 to move axially 20X.

[0044] The inclination angle of part A2(SA2) relative to part A1(SA1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. This makes it less likely for one end of the medical sheath 20 to be damaged and makes it less likely for the medical sheath 20 to move in the axial direction 20X. On the other hand, the inclination angle is preferably 90 degrees or less, more preferably 45 degrees or less, and even more preferably 30 degrees or less. This makes it easier to attach and detach the medical sheath 20. The inclination angle is the inclination angle of the imaginary line segment connecting both ends of part A2(SA2) relative to the imaginary line segment connecting both ends of part A1(SA1).

[0045] The inclination angle of portion B2 (SB2) relative to portion B1 (SB1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. This makes it less likely for one end of the medical sheath 20 to be damaged and also makes it less likely for the medical sheath 20 to move in the axial direction 20X. On the other hand, the inclination angle is preferably 90 degrees or less, more preferably 45 degrees or less, and even more preferably 30 degrees or less. This makes it easier to attach and detach the medical sheath 20. The inclination angle is the inclination angle of the imaginary line segment connecting both ends of portion B2 (SB2) relative to the imaginary line segment connecting both ends of portion B1 (SB1).

[0046] It is preferable that portions A2 (SA2) and B2 (SB2) are linear. This allows one end of the bridge portion 13 to be tapered, making it easier to avoid damage to one end of the medical sheath 20. Portions A2 (SA2) and B2 (SB2) may also be non-linear cuts. For details on non-linear cuts, please refer to the description of the medical device 101 according to the first embodiment.

[0047] The first notch 1S has a portion A3(SA3) adjacent to the other end SA1b of portion A1(SA1) in the first direction 1X, and the second notch 2S has a portion B3(SB3) adjacent to the other end SB1b of portion B1(SB1) in the second direction 2X, and it is preferable that portions A3(SA3) and B3(SB3) extend in a direction away from each other from the other end SA1b of portion A1(SA1) and the other end SB1b of portion B1(SB1). By having portions A3(SA3) and B3(SB3) that extend in a direction away from each other, the force applied to the medical sheath 20 near the other end SA1b and the other end SB1b can be alleviated, so that the other end of the medical sheath 20 is less likely to be damaged. In addition, this makes it difficult for the medical sheath 20 to move in the axial direction 20X.

[0048] The inclination angle of portion A3(SA3) relative to portion A1(SA1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. This makes it less likely for the other end of the medical sheath 20 to be damaged and makes it less likely for the medical sheath 20 to move in the axial direction 20X. On the other hand, the inclination angle is preferably 90 degrees or less, more preferably 45 degrees or less, and even more preferably 30 degrees or less. This makes it easier to attach and detach the medical sheath 20. The inclination angle is the inclination angle of the imaginary line segment connecting both ends of portion A3(SA3) relative to the imaginary line segment connecting both ends of portion A1(SA1).

[0049] The inclination angle of portion B3 (SB3) relative to portion B1 (SB1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. This makes it less likely for the other end of the medical sheath 20 to be damaged and makes it less likely for the medical sheath 20 to move in the axial direction 20X. On the other hand, the inclination angle is preferably 90 degrees or less, more preferably 45 degrees or less, and even more preferably 30 degrees or less. This makes it easier to attach and detach the medical sheath 20. The inclination angle is the inclination angle of the imaginary line segment connecting both ends of portion B3 (SB3) relative to the imaginary line segment connecting both ends of portion B1 (SB1).

[0050] It is preferable that portions A3 (SA3) and B3 (SB3) are linear. This allows the other end of the bridge portion 13 to be tapered, making it easier to avoid damage to the other end of the medical sheath 20. Portions A3 (SA3) and B3 (SB3) may also be non-linear cuts. For details on non-linear cuts, please refer to the description of the medical device 101 according to the first embodiment.

[0051] As shown in Figures 4 and 6, it is preferable that portion A1 (SA1) is longer than portion A2 (SA2) and longer than portion A3 (SA3), and that portion B1 (SB1) is longer than portion B2 (SB2) and longer than portion B3 (SB3). With this configuration, the bridge portion 13 of the sheet 10 between portion A1 (SA1) and portion B1 (SB1) can support the inner lumen 20L side of the medical sheath 20 along the axial direction 20X.

[0052] As shown in Figure 4, in the portion of the sheet 10 positioned in the lumen 20L of the medical sheath 20, the distance from portion A1 (SA1) to portion B1 (SB1) in the direction 20Y perpendicular to the axial direction 20X of the medical sheath 20 is preferably shorter than the diameter of the lumen 20L of the medical sheath 20. This makes it easier to position the bridge portion 13 of the sheet 10 between portion A1 (SA1) and portion B1 (SB1) in the lumen 20L of the medical sheath 20. Furthermore, this makes it easier to reduce the opening of the notch 20S during heat sterilization. Moreover, as shown in Figure 5, this makes it more difficult for the medical sheath 20 to pass through the hole 14 formed along the shape of the bridge portion 13, making it easier to grasp the medical sheath 20 when removing it. The distance is preferably 0.95 times or less the diameter, and more preferably 0.90 times or less the diameter. On the other hand, the distance is preferably 0.70 times or more the diameter, and more preferably 0.80 times or more the diameter. This makes it easier for the bridge portion 13 to support the inner lumen 20L side of the medical sheath 20.

[0053] 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 CC 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 plan view of a modified example of the sheet of Figure 9. Detailed explanations of the parts of the medical device according to the third embodiment that overlap with the medical devices according to the first and second embodiments will be omitted.

[0054] As shown in Figures 7 and 9, the sheet 10 of the medical device 103 according to the third embodiment differs from the sheet 10 of the medical device 102 according to the second embodiment in that it has a third notch 3S. The third notch 3S will be described in detail below.

[0055] As shown in Figures 7 and 9, it is preferable that the sheet 10 has a third notch 3S passing through one point in part A1(SA1) excluding both ends of part A1(SA1) and one point in part B1(SB1) excluding both ends of part B1(SB1). The first flap 11 and the second flap 12 can be formed by part A1(SA1), part B1(SB1), and the third notch 3S. Since the first flap 11 and the second flap 12 can be moved independently, they are easy to insert into the lumen 20L of the medical sheath 20. Furthermore, even if the medical sheath 20 does not have a notch 20S extending in the axial direction 20X, the first flap 11 and the second flap 12 can be inserted into the lumen 20L of the medical sheath 20, as shown in Figure 8. Furthermore, when the first flap 11 and the second flap 12 are lifted, a hole 14 is formed between part A1 (SA1) and part B1 (SB1). As a result, even when pressure is applied from above, at least a portion of the medical sheath 20 can move downwards, making the medical sheath 20 less susceptible to deformation.

[0056] The third cut 3S is preferably straight. This makes it easier to manufacture the sheet 10, thereby reducing costs.

[0057] As shown in Figure 9, it is preferable that the third notch 3S is located on the side closer to one end SA1a of portion A1 (SA1) in the first direction 1X, and on the side closer to one end SB1a of portion B1 (SB1) in the second direction 2X, where SB1a and SB1b are located. This makes it possible to form a first flap 11 with a long extension length and a second flap 12 with a short extension length. For example, after inserting the first flap 11 and the second flap 12 into the lumen 20L of the medical sheath 20 and sterilizing them by heat, the first flap 11 with a long extension length can be smoothly removed by first removing the second flap 12 with a short extension length. Furthermore, in the case of the medical sheath 20 shown in Figure 3, it is preferable that a second flap 12 with a shorter extension length is inserted on the opening 20O side, and a first flap 11 with a longer extension length 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 sheet 10. Also, when removing the medical sheath 20 from the sheet 10, the first flap 11 and the second flap 12, which are inserted from the opening 20O and the opening on the opposite side, respectively, can be removed from the medical sheath 20 from the sheet 10 more easily, rather than from the notch 20S of the medical sheath 20.

[0058] The third notch 3S is preferably located at a distance of 0.51 to 0.80 times the straight-line distance from the other end SA1b to the first end SA1a, and more preferably at a distance of 0.55 to 0.70 times. Furthermore, the third notch 3S is preferably located at a distance of 0.51 to 0.80 times the straight-line distance from the other end SB1b to the first end SB1a, and more preferably at a distance of 0.55 to 0.70 times. This makes it possible to achieve both the fixation of the medical sheath 20 by the first flap 11 and the second flap 12 and ease of attachment and detachment.

[0059] As shown in Figure 10, the width of the third notch 3S is preferably greater than the width of the first notch 1S. This makes it less likely for the tip of the first flap 11 and the tip of the second flap 12 to come into contact when the sheet 10 is curved as a whole, thus making it easier to avoid compression from the lumen 20L of the medical sheath 20 caused by such contact. For this reason, the width of the third notch 3S is preferably 1.1 times or more the width of the first notch 1S, more preferably 2 times or more, even more preferably 5 times or more, and even more preferably 10 times or more. On the other hand, the width of the third notch 3S is preferably 500 times or less the width of the first notch 1S, more preferably 200 times or less, even more preferably 100 times or less, and even more preferably 50 times or less. This makes it easier for the first flap 11 and the second flap 12 to support the lumen 20L side of the medical sheath 20 as a whole.

[0060] The width of the second cut 2S is preferably 0.9 times or more and 1.1 times or less the width of the first cut 1S. This makes it easier to manufacture the sheet 10, thereby reducing costs.

[0061] The following describes the medical device according to the fourth embodiment with reference to Figure 11. Figure 11 is a plan view of the medical device according to the fourth embodiment. Note that detailed explanations of the parts of the medical device according to the fourth embodiment that overlap with the medical devices according to the first, second, and third embodiments will be omitted.

[0062] As shown in Figure 11, the medical device 104 according to the fourth embodiment comprises a sheet 10 having a first notch 1S and a medical sheath 20, wherein at least a portion of the notch edge 1Ea of the first notch 1S is positioned in the lumen 20L of the medical sheath 20. Furthermore, it is preferable that the medical device 104 has a portion A1(SA1) in which the first notch 1S extends in a first direction 1X, and the sheet 10 has a second notch 2S, wherein the second notch 2S extends in a second direction 2X and has a portion B1(SB1) that faces portion A1(SA1) in the width direction.

[0063] As shown in Figure 11, the first notch 1S has a portion A2(SA2) adjacent to one end SA1a of portion A1(SA1) in the first direction 1X, and the second notch 2S has a portion B2(SB2) adjacent to one end SB1a of portion B1(SB1) in the second direction 2X, and it is preferable that one end SB1a of portion B1(SB1) is closer to one end SA1a of portion A1(SA1) than the other end SA1b of portion A1(SA1) in the first direction 1X, and that portion A2(SA2) and portion B2(SB2) extend in directions away from each other from one end SA1a of portion A1(SA1) and one end SB1a of portion B1(SB1). Furthermore, it is preferable that the first cut 1S has a portion A3(SA3) adjacent to the other end SA1b of portion A1(SA1) in the first direction 1X, and the second cut 2S has a portion B3(SB3) adjacent to the other end SB1b of portion B1(SB1) in the second direction 2X, and that portion A3(SA3) and portion B3(SB3) extend in directions away from each other from the other end SA1b of portion A1(SA1) and the other end SB1b of portion B1(SB1).

[0064] As shown in Figure 11, it is preferable that portion A1(SA1) is shorter than portion A2(SA2) and shorter than portion A3(SA3), and portion B1(SB1) is shorter than portion B2(SB2) and shorter than portion B3(SB3). With this configuration, a first flap 11 can be formed by portions A1(SA1), A2(SA2), and A3(SA3), and a second flap 12 can be formed by portions B1(SB1), B2(SB2), and B3(SB3). Since the first flap 11 and the second flap 12 can be moved independently, it is possible to easily position a part of the sheet 10 in the lumen 20L of the medical sheath 20. Furthermore, even if the medical sheath 20 does not have a notch 20S extending in the axial direction 20X, a part of the sheet 10 can be positioned in the lumen 20L of the medical sheath 20.

[0065] In the portion of the sheet 10 positioned in the lumen 20L of the medical sheath 20, it is preferable that the distance from portion A2 (SA2) to portion A3 (SA3) in the direction 20Y perpendicular to the axial direction 20X of the medical sheath 20 is shorter than the diameter of the lumen 20L of the medical sheath 20, and that the distance from portion B2 (SB2) to portion B3 (SB3) in the direction 20Y perpendicular to the axial direction 20X of the medical sheath 20 is shorter than the diameter of the lumen 20L of the medical sheath 20. This makes it easier to position the first flap 11 and the second flap 12 in the lumen 20L of the medical sheath 20. The distance is preferably 0.95 times the diameter or less, and more preferably 0.90 times the diameter or less. On the other hand, the distance is preferably 0.70 times the diameter or more, and more preferably 0.80 times the diameter or more. This makes it easier to support the lumen 20L side of the medical sheath 20 with the first flap 11 and the second flap 12.

[0066] Parts A2 (SA2), A3 (SA3), B2 (SB2), and B3 (SB3) are preferably linear. This makes it easier to position the first flap 11 and the second flap 12 in the lumen 20L of the medical sheath 20. Parts A2 (SA2), A3 (SA3), B2 (SB2), and B3 (SB3) may also be non-linear cuts. For details on non-linear cuts, please refer to the description of the medical device 101 according to the first embodiment.

[0067] The lengths of section A2 (SA2) and section A3 (SA3) are preferably 0.30 to 0.80 times the axial length 20X of the medical sheath 20, more preferably 0.50 to 0.70 times, and even more preferably 0.55 to 0.60 times. On the other hand, the lengths of section B2 (SB2) and section B3 (SB3) are preferably 0.20 to 0.70 times the axial length 20X of the medical sheath 20, more preferably 0.30 to 0.50 times, and even more preferably 0.40 to 0.45 times. Furthermore, it is preferable that section A2 (SA2) is longer than section B2 (SB2), and section A3 (SA3) is longer than section B3 (SB3). This makes it possible to make the length of the first flap 11 in the extending direction longer than the length of the second flap 12 in the extending direction.

[0068] The inclination angles of portion A2(SA2) and portion A3(SA3) with respect to portion A1(SA1) are preferably 70 degrees or more and 95 degrees or less, more preferably 80 degrees or more and 93 degrees or less, even more preferably 85 degrees or more and 91 degrees or less, and most preferably 90 degrees. This makes it easier for the first flap 11 to support the medical sheath 20 from the lumen 20L side. The inclination angle of portion A2(SA2) with respect to portion A1(SA1) is the inclination angle of the imaginary line segment connecting both ends of portion A2(SA2) with respect to the imaginary line segment connecting both ends of portion A1(SA1). Similarly, the inclination angle of portion A3(SA3) with respect to portion A1(SA1) is the inclination angle of the imaginary line segment connecting both ends of A3(SA3) with respect to the imaginary line segment connecting both ends of portion A1(SA1). For example, if the inclination angles of portion A2 (SA2) and portion A3 (SA3) with respect to portion A1 (SA1) are 70 degrees or more and less than 90 degrees, respectively, the shape of the first flap 11 will be tapered.

[0069] The inclination angles of portion B2 (SB2) and portion B3 (SB3) with respect to portion B1 (SB1) are preferably 70 degrees or more and 95 degrees or less, more preferably 80 degrees or more and 93 degrees or less, even more preferably 85 degrees or more and 91 degrees or less, and most preferably 90 degrees. This makes it easier for the medical sheath 20 to be supported from the lumen 20L side by the second flap 12. The inclination angle of portion B2 (SB2) with respect to portion B1 (SB1) is the inclination angle of the imaginary line segment connecting the ends of portion B2 (SB2) with respect to the imaginary line segment connecting the ends of portion B1 (SB1). Similarly, the inclination angle of portion B3 (SB3) with respect to portion B1 (SB1) is the inclination angle of the imaginary line segment connecting the ends of portion B3 (SB3) with respect to the imaginary line segment connecting the ends of portion B1 (SB1). For example, if the inclination angles of portion B2 (SB2) and portion B3 (SB3) with respect to portion B1 (SB1) are 70 degrees or more and less than 90 degrees, respectively, the shape of the second flap 12 will be tapered.

[0070] The following describes the medical device according to the fifth embodiment, with reference to Figure 12. Figure 12 is a plan view of the medical device according to the fifth embodiment. Note that detailed explanations of the parts of the medical device according to the fifth embodiment that overlap with the medical devices according to the first, second, third, and fourth embodiments will be omitted.

[0071] As shown in Figure 12, the medical device 105 according to the fifth embodiment comprises a sheet 10 having a first notch 1S and a medical sheath 20, wherein at least a portion of the notch edge 1Ea of the first notch 1S is positioned in the lumen 20L of the medical sheath 20.

[0072] As shown in Figure 12, the medical device 105 further includes a medical tubular body 40 and a protective tube 30 in which at least a portion of the medical tubular body 40 is disposed inside. The sheet 10 has a pair of notches 4S, and the notch edges 4E of the pair of notches 4S each hold the wound protective tube 30. Preferably, the first notch 1S and the second notch 2S are located outside the region 4R extending from one notch 4S1 to the other notch 4S2 of the pair of notches 4S. Since region 4R is a region that is easily deformed when attaching or detaching the protective tube 30, by placing the medical sheath 20 in the region outside of region 4R, it is possible to prevent the medical sheath 20 from detaching at an unintended time. Conversely, when attaching or detaching the medical sheath 20, it is possible to prevent the protective tube 30 from detaching at an unintended time.

[0073] Preferably, the pair of flaps formed by the pair of notches 4S each extend outward from the sheet 10. This makes it easier for each flap to hold the wound protective tube 30.

[0074] The medical sheath 20 is preferably located inside the wound protective tube 30. This arrangement reduces the pressure on the medical sheath 20 when the medical devices 105 are stacked.

[0075] As shown in Figure 12, the medical device 105 has a medical sheath 20, a protective tube 30, and a medical tubular body 40, allowing the medical sheath 20, protective tube 30, and medical tubular body 40 to be sterilized together. The sheet 10 may have other notches. The medical device 105 may also have other components, which may be fixed to the sheet 10 by the notched edges of one or more other notches. Examples of other components include syringes, mandrels, guidewires, needles, dilators, relappers, torquers, stopcocks, adapters, etc.

[0076] The shape of the outer edge of the cross-section of the protective tube 30 in the thickness direction 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 shape of the outer edge of the inner lumen of the cross-section of the protective tube 30 in the thickness direction 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 30 may contain polyethylene, polypropylene, polyolefin resin such as ethylene-propylene copolymer and ethylene-vinyl acetate copolymer, polyvinyl chloride resin, polystyrene resin, polyamide resin, polyimide resin, or a mixture thereof.

[0077] The outer diameter of the protective tube 30 in the thickness direction is preferably larger than the outer diameter of the medical sheath 20. This makes it less likely for the medical sheath 20 to deform when multiple medical devices 105 are stacked.

[0078] The medical tubular body 40 is preferably a balloon catheter, a microcatheter, or a penetrating catheter, and more preferably a balloon catheter. The medical tubular body 40 also preferably has a handle at its proximal end. The protective tube 30 only needs to be capable of holding at least a portion of the medical tubular body 40 inside. The protective tube 30 is preferably fixed in shape by multiple clips while wound. The medical device 105 does not necessarily have a protective tube 30. In that case, the medical tubular body 40 can be held between the notched edges 4E of the pair of notches 4S. [Explanation of Symbols]

[0079] 1Ea, 1Eb, 2Ea, 2Eb Cut-out edge 1S First cut SA1 Part A1 SA1a one end SA1b other end SA2 Part A2 SA3 Part A3 1X 1st direction 2S Second cut SB1 Part B1 SB1a one end SB1b other end SB2 Part B2 SB3 Part B3 2X 2nd direction 3S Third cut 4S Pair of cuts 4S1 One-sided cut 4S2 Other cut 4R area 4E cut edge 10 sheets 10F Flap 11 First flap 12. Second flap 13 Hashibe 14 Hole 20 Medical Sheaths 20L lumen 20X Axial 20S cut 20Y Vertical direction 20O opening 30 Protection tube 40 Medical tubular body 101, 102, 103, 104, 105 Medical devices

Claims

1. A medical sheath, The medical sheath comprises a sheet having a first notch for supporting the luminal side of the medical sheath, wherein at least a portion of the notch edge of the first notch is straight, A medical device in which the edge of the first notch extends along the longitudinal direction of the lumen of the medical sheath and is in contact with the inner surface of the medical sheath.

2. The first cut has a portion A1 that extends in the first direction, The medical device according to claim 1, wherein the sheet has a second notch, and the second notch extends in a second direction and has a portion B1 that faces the portion A1 in the width direction.

3. The medical device according to claim 2, wherein the portion A1 and the portion B1 are each linear.

4. The medical device according to claim 2 or 3, wherein the first direction and the second direction are parallel.

5. The first cut has a portion A2 adjacent to one end of the portion A1 in the first direction, The second cut has a portion B2 adjacent to one end of the portion B1 in the second direction, and one end of the portion B1 is closer to one end of the portion A1 than the other end of the portion A1 in the first direction. The medical device according to claim 2 or 3, wherein the portion A2 and the portion B2 extend in directions away from each other from one end of the portion A1 and one end of the portion B1.

6. The first cut has a portion A3 adjacent to the other end of the portion A1 in the first direction, The second cut has a portion B3 adjacent to the other end of the portion B1 in the second direction. The medical device according to claim 5, wherein the portion A3 and the portion B3 extend in directions away from each other from the other end of the portion A1 and the other end of the portion B1.

7. The portion A1 is longer than the portion A2 and longer than the portion A3. The medical device according to claim 6, wherein portion B1 is longer than portion B2 and longer than portion B3.

8. The medical device according to claim 2 or 3, wherein in the portion of the sheet positioned within the lumen of the medical sheath, the distance from portion A1 to portion B1 in a direction perpendicular to the axial direction of the medical sheath is shorter than the diameter of the lumen of the medical sheath.

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

10. The medical device according to claim 2 or 3, wherein the sheet has a third cut passing through one point in the portion A1 excluding both ends of the portion A1 and one point in the portion B1 excluding both ends of the portion B1.

11. The medical device according to claim 10, wherein the third notch is located on the side closer to one end of the portion A1 in the first direction and on the side closer to one end of the portion B1 in the second direction.

12. The medical device according to claim 10, wherein the width of the third cut is greater than the width of the first cut.

13. The portion A1 is shorter than the portion A2 and shorter than the portion A3. The medical device according to claim 6, wherein portion B1 is shorter than portion B2 and shorter than portion B3.

14. In the portion of the sheet that is positioned inside the lumen of the medical sheath, The distance from portion A2 to portion A3 in a direction perpendicular to the axial direction of the medical sheath is shorter than the diameter of the lumen of the medical sheath, and The medical device according to claim 13, wherein the distance from portion B2 to portion B3 in a direction perpendicular to the axial direction of the medical sheath is shorter than the diameter of the lumen of the medical sheath.

15. Furthermore, it comprises a medical tubular body and a protective tube in which at least a portion of the medical tubular body is disposed inside, The sheet has a pair of notches, and the edges of the pair of notches each hold the wound protective tube. The medical device according to claim 2 or 3, wherein the first and second notches are located outside the region from one of the pair of notches to the other.

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