Medical Instrument Set

Abstract

To provide a medical device set facilitating sterilization of medical sheaths in a stacked state.SOLUTION: A medical device set comprises a base material sheet, a medical sheath with an axial direction detachably fixed to one surface side of the base material sheet, a medical device with a longitudinal direction detachably fixed to the one surface side of the base material sheet, and a packaging bag containing the base material sheet, the medical sheath, and the medical device. The medical sheath includes a first flap formed by a first cut and a first hole formed by erection of the first flap, where the first flap supports the medical device. The medical sheath and the medical device are disposed in a region of one side out of the one side and the other side partitioned by a virtual straight line passing through a centroid of the base material sheet, where a long diameter of the base material sheet has a length equal to or less than twice a short diameter. The packaging bag has a ventilation part at a position facing the other surface side opposite to the one surface side of the base material sheet.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a medical instrument set in which the medical sheath is easy to sterilize. [Background technology]

[0002] Conventionally, long medical devices such as catheters and guidewires have sometimes been fixed to a mount when unused. For example, Patent Document 1 discloses a medical device holder mount 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 medical device holder mount having a holding portion that holds the medical device, the holding portion being formed by folding the sheet material into a V-shape along the longitudinal direction of the sheet material, and having a V-shaped groove that holds the linear portion of the medical device, and a W-shaped groove formed at the base end of the V-shaped groove by folding the valley portion in the opposite direction to form a mountain-like shape. Patent Document 2 discloses a medical device packaging member characterized by forming one or more restraining pieces by cutting a thin, flat plate or dish-shaped body made of paper or soft synthetic resin, making a notch with an arch-shaped end at approximately the center of the restraining piece, cutting from the arch-shaped end of the notch to the end of the restraining piece to form a stress-relieving section, and folding the restraining piece from its base end at a folding section. Patent Document 3 discloses a holding mount that holds a medical device on a holding surface with multiple tabs, and at least one specific tab of the multiple tabs clamps the medical device at a position spaced from the holding surface. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-201826 [Patent Document 2] Japanese Patent Application Laid-Open No. 2002-193322 [Patent Document 3] Japanese Patent Application Laid-Open No. 2016-064089 Summary of the Invention [Problem to be solved by the invention]

[0004] Conventionally, there have been cases where a long medical device fixed to a mount as in Patent Documents 1 to 3 is packaged in a bag and sterilized in the packaged state. 3 Sterilization methods using high-pressure steam, sterilizing gas, or the like in a sterilization apparatus of about 100 mm diameter have been adopted. In particular, when using mounts with an easily stackable shape, such as the substantially square mount described in Patent Document 3, it has been common to stack, for example, 60 packages in a sterilization basket for sterilization. Furthermore, medical sheaths, syringes, and the like have sometimes been fixed to such mounts. In recent years, however, there has been a demand for improved sterilization levels for medical sheaths that have small inner diameters and are difficult to sterilize when sterilizing stacked packages as described above. The present invention has been made in response to the above-described problems, and its purpose is to provide a medical instrument set in which medical sheaths can be easily sterilized when stacked. [Means for solving the problem]

[0005] A medical instrument set according to an embodiment of the present invention that can solve the above problems is as follows. [1] A base sheet; a medical sheath having an axial direction detachably fixed to one side of the base sheet; a medical device having a longitudinal direction and detachably fixed to the one surface side of the base sheet; a packaging bag containing the base sheet, the medical sheath, and the medical device, the base sheet has a first flap formed by a first cut and a first hole formed by the first flap standing up, the first flap supporting the medical device, the medical sheath and the medical device are disposed in one region of one side and the other side defined by an imaginary line passing through the centroid of the base sheet, The major axis of the base sheet is equal to or less than twice the minor axis, The packaging bag has a ventilation part at a position facing the other side of the base sheet opposite to the one side.

[0006] As described above, by arranging the medical sheath and the longitudinal medical instrument in one region of the base sheet, the distance between the first hole near the medical instrument and the medical sheath becomes shorter, making it easier for the sterilization gas that passes through the ventilation section of the packaging bag to pass further through the first hole and be supplied to the medical sheath. Furthermore, with this arrangement, the other region of the base sheet is pressed down when other medical instrument sets are stacked on top of it, narrowing the space and reducing the overall volume of the space within the packaging bag, allowing the sterilization gas to be supplied efficiently to the medical sheath.

[0007] The medical instrument set according to the embodiment is preferably any one of the following [2] to

[12] . [2] The medical instrument set according to [1], wherein the length of the minor axis of the first hole portion is greater than the outer diameter of the medical sheath. [3] The medical instrument set according to [1] or [2], wherein the shortest distance from one end of the medical sheath in the axial direction to the first hole portion is less than half the length of the medical sheath in the axial direction. [4] The medical instrument set according to any one of [1] to [3], wherein the medical sheath is disposed at a position farther from the centroid of the base sheet than the medical instrument. [5] The medical instrument set according to any one of [1] to [4], wherein the angle formed between the axial direction of the medical sheath and the longitudinal direction of the medical instrument is 20 degrees or less. [6] The medical instrument set according to any one of [1] to [5], wherein the medical instrument has a tubular portion, and the outer diameter of the tubular portion is larger than the outer diameter of the medical sheath. [7] The medical instrument set according to [6], wherein the first flap supports the tubular portion. [8] The medical instrument set according to any one of [1] to [7], wherein the base sheet has a second flap formed by a second incision and a second hole formed by the standing of the second flap, and the second flap supports the medical instrument. [9] A medical device set according to any one of [1] to [8], further comprising a medical elongated body and a protective tube in which at least a portion of the medical elongated body is disposed, the protective tube being wound around and detachably fixed to the one side of the base sheet, and the medical sheath and the medical device being disposed inside the wound protective tube.

[10] The medical instrument set according to [9], wherein the base sheet has a pair of flaps formed by a pair of cuts and a pair of holes formed by the standing of the pair of flaps, and the pair of flaps removably fix the protective tube.

[11] The medical instrument set according to

[10] , wherein the medical sheath is located outside the area extending from one of the pair of notches to the other notch.

[12] The medical instrument set according to any one of [9] to

[11] , wherein the outer diameter of the protective tube is larger than the outer diameter of the medical sheath. [Effects of the Invention]

[0008] According to the present invention, it is possible to provide a medical instrument set in which the medical sheaths can be easily sterilized when stacked. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a plan view of one surface of a medical instrument set according to a first embodiment. [Figure 2] FIG. 2 is a plan view of the other surface side of the medical instrument set according to the first embodiment. [Figure 3] FIG. 3 is a cross-sectional view showing the AA cross section of FIG. [Figure 4] FIG. 4 is a plan view of the base sheet before the components of FIG. 1 are arranged. [Figure 5] FIG. 5 is a plan view of an example of a medical sheath. [Figure 6] FIG. 6 is a plan view of one surface of the medical instrument set according to the second embodiment. [Figure 7]FIG. 7 is a plan view of the other surface side of the medical instrument set according to the second embodiment. [Figure 8] FIG. 8 is a plan view of the base sheet before the components of FIG. 6 are arranged. DETAILED DESCRIPTION OF THE INVENTION

[0010] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, component reference numerals may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0011] A medical instrument set according to an embodiment of the present invention comprises a base sheet, a medical sheath having an axial direction that is detachably fixed to one side of the base sheet, a medical instrument having a longitudinal direction that is detachably fixed to one side of the base sheet, and a packaging bag containing the base sheet, the medical sheath, and the medical instrument, wherein the base sheet has a first flap formed by a first incision and a first hole formed by the rising of the first flap, and the first flap supports the medical instrument, the medical sheath and the medical instrument are arranged in an area on one side of the base sheet defined by an imaginary line passing through the centroid of the base sheet, the major axis of the base sheet is no more than twice the minor axis, and the packaging bag has a ventilation portion located opposite the one side of the base sheet.

[0012] As described above, by arranging the medical sheath and the longitudinal medical instrument in one region of the base sheet, the distance between the first hole near the medical instrument and the medical sheath becomes shorter, making it easier for the sterilization gas that passes through the ventilation section of the packaging bag to pass further through the first hole and be supplied to the medical sheath. Furthermore, with this arrangement, the other region of the base sheet is pressed down when other medical instrument sets are stacked on top of it, narrowing the space and reducing the overall volume of the space within the packaging bag, allowing the sterilization gas to be supplied efficiently to the medical sheath.

[0013] A medical instrument set according to a first embodiment will be described below with reference to Figures 1, 2, 3, and 4. Figure 1 is a plan view of one side of the medical instrument set according to the first embodiment, and Figure 2 is a plan view of the other side. Figure 3 is a cross-sectional view showing the AA cross section of Figure 1. Figure 4 is a plan view of the base sheet before the components of Figure 1 are arranged.

[0014] 1, 2, and 3, a medical instrument set 101 according to a first embodiment includes a base sheet 10, a medical sheath 20 having an axial direction 20X and detachably fixed to one side 10A of the base sheet 10, a medical instrument 30 having a longitudinal direction 30X and detachably fixed to the one side 10A of the base sheet 10, and a packaging bag 40 containing the base sheet 10, the medical sheath 20, and the medical instrument 30. The base sheet 10 has a first flap 1F formed by a first incision 1S and a first hole 1H formed by the rising of the first flap 1F, and the first flap 1F supports the medical instrument 30. The medical sheath 20 and the medical instrument 30 are arranged in a region on one side 10J of a side 10J and a second side 10K defined by an imaginary straight line 10D passing through a centroid 10C of the base sheet 10. The major axis 10L of the base sheet 10 is equal to or less than twice the minor axis 10M. The packaging bag 40 has a ventilation portion 40V at a position facing the other side 10B of the base sheet 10 opposite to the one side 10A.

[0015] The medical sheath 20 and the medical instrument 30 having the longitudinal direction 30X are arranged in the region of one side 10J of the one side 10J and the other side 10K defined by an imaginary straight line 10D passing through the centroid 10C of the base sheet 10, thereby reducing the distance between the first hole 1H near the medical instrument 30 and the medical sheath 20. As a result, sterilization gas that has passed through the ventilation portion 40V of the packaging bag 40 facing the other side 10B of the base sheet 10 is easily supplied to the medical sheath 20 through the first hole 1H.

[0016] The centroid 10C of the base sheet 10 corresponds to the center of gravity of the figure formed by the outer edges of the base sheet 10 in a plan view. Therefore, one side 10J and the other side 10K defined by an imaginary straight line 10D passing through the centroid 10C of the base sheet 10 each correspond to half of the area of ​​the base sheet 10.

[0017] 3, by arranging the medical sheath 20 and medical instrument 30 in region 10J on one side of the base sheet 10, region 10K on the other side of the base sheet 10 is pressed down and the space becomes narrower when other medical instrument sets are stacked on top of it. As a result, the overall volume of the space inside the packaging bag 40 is reduced, allowing sterilizing gas to be supplied efficiently to the medical sheath 20.

[0018] As shown in FIG. 1, the major axis 10L of the base sheet 10 is less than twice the length of the minor axis 10M. This makes the shape of the outer edge of the base sheet 10 in a plan view closer to a square, making it easier to stack. Therefore, the major axis 10L is preferably less than 1.8 times the length of the minor axis 10M, more preferably less than 1.5 times the length of the minor axis 10M, and even more preferably less than 1.2 times the length of the minor axis 10M. On the other hand, the major axis 10L may be 1.00 times or more the length of the minor axis 10M, or may be 1.05 times or more the length of the minor axis 10M.

[0019] In a plan view of the base sheet 10, the major axis 10L of the base sheet 10 is preferably the longest imaginary line segment that passes through the centroid 10C and has both end points on the outer edge of the base sheet 10. On the other hand, in a plan view of the base sheet 10, the minor axis 10M of the base sheet 10 is preferably the shortest imaginary line segment that passes through the centroid 10C and has both end points on the outer edge of the base sheet 10. Furthermore, the major axis 10L and the minor axis 10M may be the same length, as in the case where the shape of the base sheet 10 in a plan view is square.

[0020] The shape of the base sheet 10 in a plan view is preferably a circle, an ellipse, a polygon, a rounded polygon, or a combination thereof, more preferably a polygon or a rounded polygon, and even more preferably a rectangle or a rounded rectangle. When the shape of the base sheet 10 is a polygon or a rounded polygon, for example, the distances between the centroid 10C and each of the vertices T1, T2, T3, and T4 of the outer edge of the base sheet 10 may all be the same as shown in Fig. 4, or there may be a vertex T1 that is closer to the centroid 10C than the other vertices T2, T3, and T4, as shown in Fig. 8.

[0021] The area of ​​the region surrounded by the outer edge of the base sheet 10 is 50 cm 2 More than 1000cm 2 Preferably, it is less than 300 cm 2 More than 600cm 2 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 improves the handleability of the base sheet 10.

[0022] The base sheet 10 preferably includes a resin layer, a paper layer, or a laminate thereof, and more preferably includes 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 may include two or more paper layers.

[0023] The resin layer is preferably a polyolefin layer, a fluororesin layer, a polyester layer, a polyurethane layer, a polystyrene layer, a polycarbonate layer, a silicone layer, a polyamide layer, or a polyimide layer, more preferably a polyolefin layer or a fluororesin layer, and even more preferably a polyolefin layer. This makes it easier to attach and detach each member to and from the base sheet 10. These may be used alone or in combination of two or more types. 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 a silicone resin. The polyamide layer preferably contains nylon. The polyimide layer preferably contains polyetherimide.

[0024] The paper layer is preferably made of fine paper, medium-quality paper, kraft paper, semi-gloss kraft paper, or latex-impregnated paper. These may be used alone or in combination of two or more.

[0025] As described above, the base sheet 10 has a first flap 1F formed by the first incision 1S and a first hole 1H formed by the standing of the first flap 1F, and the first flap 1F supports the medical device 30. As shown in Fig. 1, on one surface 10A of the base sheet 10, the first flap 1F formed by the first incision 1S stands up toward the upper side, i.e., the front side, and it is preferable that the first hole 1H is formed on the lower side, i.e., the back side, of the first flap 1F.

[0026] The shape of the first cut 1S is preferably U-shaped, V-shaped, U-shaped or S-shaped, more preferably U-shaped or U-shaped, and even more preferably U-shaped.

[0027] The shape of the outer edge of the first flap 1F is preferably U-shaped, V-shaped, U-shaped, or S-shaped, more preferably U-shaped or U-shaped, and even more preferably U-shaped, which makes it easier for the first flap 1F to support the medical device 30.

[0028] The shape of the outer edge of the first hole 1H is preferably semicircular, semielliptical, triangular, rectangular, or a combination thereof.

[0029] The length of the minor axis of the first hole 1H is preferably larger than the outer diameter of the medical sheath 20. This allows the sterilization gas to pass through the first hole 1H more easily, facilitating the supply of the sterilization gas to the medical sheath 20. Therefore, the length of the minor axis of the first hole 1H is preferably at least twice the outer diameter of the medical sheath 20, and more preferably at least five times the outer diameter of the medical sheath 20. On the other hand, when the length of the minor axis of the first hole 1H is 30 times or less the outer diameter of the medical sheath 20, the strength of the base sheet 10 is improved. Therefore, the length of the minor axis of the first hole 1H is preferably at most 30 times the outer diameter of the medical sheath 20, and more preferably at most 20 times the outer diameter of the medical sheath 20. The minor axis of the first hole 1H is preferably the shortest imaginary line segment that passes through the centroid of the figure formed by the outer edge of the first hole 1H in a direction parallel to the main surface (the surface on one side 10A) of the base sheet 10 and has both end points on the outer edge of the first hole 1H. The same applies to the minor diameter of each hole below.

[0030] The length of the minor axis of the first hole 1H is preferably larger than the outer diameter of the tubular portion 30T of the medical device 30. This makes it easier for the first flap 1F, which has a shape corresponding to the shape of the first hole 1H, to support the medical device 30, and also makes it easier for the sterilization gas to pass through the first hole 1H. Therefore, the length of the minor axis of the first hole 1H is preferably 1.2 times or more, and more preferably 1.4 times or more, the outer diameter of the tubular portion 30T of the medical device 30. On the other hand, by making the length of the minor axis of the first hole 1H four times or less the outer diameter of the tubular portion 30T of the medical device 30, the strength of the base sheet 10 is improved. Therefore, the length of the minor axis of the first hole 1H is preferably four times or less, and more preferably three times or less, the outer diameter of the tubular portion 30T of the medical device 30.

[0031] The first flap 1F preferably extends in a direction from the distal end toward the proximal end of the medical device 30. This makes it difficult for the medical device 30 to move in the longitudinal direction 30X.

[0032] The first flap 1F preferably has a through-hole 1P. For example, by inserting the medical instrument 30 into the through-hole 1P while the first flap 1F is in an upright state, the medical instrument 30 can be easily supported.

[0033] The first flap 1F preferably supports the tubular portion 30T of the medical instrument 30. By the first flap 1F supporting the tubular portion 30T of the medical instrument 30, the medical instrument 30 becomes less likely to move.

[0034] 1, the base sheet 10 preferably has second flaps 2F formed by the second incisions 2S and second holes 2H formed by the standing of the second flaps 2F, and the second flaps 2F support the medical instrument 30. This makes it even more difficult for the medical instrument 30 to move, and allows sterilizing gas to be supplied to the medical sheath 20 through the second holes 2H.

[0035] As shown in Figure 1, the second flap 2F stands up toward the upper side, i.e., the front side, on one side 10A of the base sheet 10, and it is preferable that a second hole portion 2H is formed on the lower side, i.e., the back side, of the second flap 2F.

[0036] The second flap 2F preferably supports the proximal end of the medical device 30 in the direction from the proximal end to the distal end, thereby making it difficult for the medical device 30 to move in the longitudinal direction 30X.

[0037] 1 and 2, the base sheet 10 preferably further has a third flap 3F formed by a third incision 3S and a third hole 3H formed by the standing of the third flap 3F, and the third flap 3F supports the medical instrument 30. The base sheet 10 preferably further has a fourth flap 4F formed by a fourth incision 4S and a fourth hole 4H formed by the standing of the fourth flap 4F, and the fourth flap 4F supports the medical instrument 30. This makes it even more difficult for the medical instrument 30 to move, and allows sterilizing gas to be supplied to the medical sheath 20 via the third hole 3H and the fourth hole 4H.

[0038] As shown in Fig. 1, the third flap 3F and the fourth flap 4F each stand up toward the upper side, i.e., the front side, on one side 10A of the base sheet 10, and it is preferable that the third hole portion 3H and the fourth hole portion 4H are formed on the lower side, i.e., the rear side, of each flap. As shown in Fig. 1, it is preferable that the third flap 3F and the fourth flap 4F each support the medical device 30 by pressing down on the medical device 30 from above.

[0039] The third flap 3F preferably supports the medical device 30 more proximal than the first flap 1F. Furthermore, the fourth flap 4F preferably supports the medical device 30 more proximal than the third flap 3F. Furthermore, the third flap 3F preferably extends from the medical sheath 20 side toward the medical device 30. Furthermore, the fourth flap 4F preferably extends from the opposite side to the medical sheath 20 toward the medical device 30. This makes it difficult for the medical device 30 to move in the width direction.

[0040] It is preferable that the first flap 1F, the third flap 3F, and the fourth flap 4F support the tubular portion 30T of the medical device 30, and the second flap 2F supports the proximal end portion of the medical device 30. This makes it difficult for the medical device 30 to move in the longitudinal direction 30X and the width direction.

[0041] The shapes of the second incision 2S, the third incision 3S, and the fourth incision 4S are preferably U-shaped, V-shaped, U-shaped, or S-shaped, more preferably U-shaped or U-shaped, and even more preferably U-shaped.

[0042] The outer edges of the second flap 2F, the third flap 3F, and the fourth flap 4F are preferably U-shaped, V-shaped, U-shaped, or S-shaped, more preferably U-shaped or U-shaped, and even more preferably U-shaped, which makes it easier for the flaps to support the medical device 30.

[0043] The outer edge shape of the second hole portion 2H, the third hole portion 3H, and the fourth hole portion 4H is preferably a semicircle, a semi-ellipse, a triangle, a rectangle, or a combination thereof.

[0044] The minor axis lengths of the second hole 2H, the third hole 3H, and the fourth hole 4H are preferably larger than the outer diameter of the medical sheath 20. This allows the sterilization gas to pass through each hole more easily, facilitating the supply of the sterilization gas to the medical sheath 20. Therefore, the minor axis length is preferably at least twice the outer diameter of the medical sheath 20, and more preferably at least five times the outer diameter of the medical sheath 20. On the other hand, the strength of the base sheet 10 is improved by making the minor axis length 30 times or less the outer diameter of the medical sheath 20. Therefore, the minor axis length is preferably at most 30 times the outer diameter of the medical sheath 20, and more preferably at most 20 times the outer diameter of the medical sheath 20.

[0045] The lengths of the minor axes of the second hole 2H, the third hole 3H, and the fourth hole 4H are preferably larger than the outer diameter of the medical device 30. This makes it easier for each flap, which has a shape corresponding to the shape of each hole, to support the medical device 30, and also makes it easier for the sterilization gas to pass through each hole. Therefore, the length of the minor axis of each hole is preferably 1.1 times or more, and more preferably 1.2 times or more, the outer diameter of the medical device 30. On the other hand, by making the length of the minor axis of each hole four times or less the outer diameter of the medical device 30, the strength of the base sheet 10 is improved. Therefore, the length of the minor axis of each hole is preferably four times or less, and more preferably two times or less, the outer diameter of the medical device 30.

[0046] 4, the base sheet 10 preferably further has a fifth incision 5S and a sixth incision 6S that faces the fifth incision 5S in the width direction. The base sheet 10 preferably further has a seventh incision 7S that passes through one point excluding both ends of the fifth incision 5S and one point excluding both ends of the sixth incision 6S.

[0047] The fifth flap 5F and the sixth flap 6F can be formed by the fifth incision 5S, the sixth incision 6S, and the seventh incision 7S. By standing the fifth flap 5F and the sixth flap 6F and arranging them in the lumen 20L of the medical sheath 20, the medical sheath 20 can be held from the lumen 20L side. This makes the medical sheath 20 less likely to deform.

[0048] The base sheet 10 preferably has a fifth hole formed by the standing of the fifth flap 5F and a sixth hole formed by the standing of the sixth flap 6F. This allows sterilization gas to be supplied to the medical sheath 20 through the fifth hole and the sixth hole. In the embodiment shown in Fig. 2, the fifth hole 5H and the sixth hole 6H are connected to form a single hole, but the fifth hole 5H and the sixth hole 6H may be separate and exist independently.

[0049] As shown in FIG. 4, the fifth incision 5S preferably has a linear portion 5S0 extending linearly. Furthermore, the sixth incision 6S preferably has a linear portion 6S0 extending linearly. The extending direction of the linear portion 5S0 and the extending direction of the linear portion 6S0 are preferably parallel. This makes it easier for the fifth flap 5F and the like to support the lumen 20L side of the medical sheath 20. "Parallel" means that the angle between the extending directions 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.

[0050] As shown in FIG. 4, the fifth incision 5S preferably has a first inclined portion 5S1 adjacent to one end of the linear portion 5S0 and a second inclined portion 5S2 adjacent to the other end of the linear portion 5S0. Furthermore, the sixth incision 6S preferably has a first inclined portion 6S1 adjacent to one end of the linear portion 6S0 and a second inclined portion 6S2 adjacent to the other end of the linear portion 6S0. The first inclined portion 5S1 and the first inclined portion 6S1 preferably extend in directions away from one end of the linear portion 5S0 and one end of the linear portion 6S0, respectively. The second inclined portion 5S2 and the second inclined portion 6S2 preferably extend in directions away from the other end of the linear portion 5S0 and the other end of the linear portion 6S0, respectively. This configuration allows the base ends of the fifth flap 5F and the sixth flap 6F to be tapered, for example. The proximal ends of the fifth flap 5F and the sixth flap 6F having such shapes can reduce the force applied to both ends of the medical sheath 20 during fixation, making both ends of the medical sheath 20 less likely to be damaged. This also makes it less likely that the medical sheath 20 will move in the axial direction 20X.

[0051] The first inclined portion 5S1, the second inclined portion 5S2, the first inclined portion 6S1, and the second inclined portion 6S2 are preferably linear, but may be non-linear, such as arc-shaped or wavy.

[0052] The inclination angles of the first inclined portion 5S1 and the second inclined portion 5S2 relative to the linear portion 5S0 are each preferably 1 degree or greater, more preferably 3 degrees or greater, and even more preferably 5 degrees or greater. This makes it difficult for the end of the medical sheath 20 to be damaged and 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 easy to attach and detach the medical sheath 20. In the case of the first inclined portion 5S1, the inclination angle is the inclination angle of an imaginary line segment connecting both ends of the first inclined portion 5S1 relative to an imaginary line segment connecting both ends of the linear portion 5S0. The same applies to inclination angles hereinafter.

[0053] The inclination angles of the first inclined portion 6S1 and the second inclined portion 6S2 relative to the linear portion 6S0 are each preferably 1 degree or greater, more preferably 3 degrees or greater, and even more preferably 5 degrees or greater. This makes it difficult for the end of the medical sheath 20 to be damaged and for the medical sheath 20 to move in the axial direction 20X. On the other hand, the inclination angles are 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.

[0054] The seventh incision 7S preferably extends linearly, which makes it easier to manufacture the base sheet 10 and reduces costs.

[0055] The base sheet 10 may have only the fifth incision 5S among the fifth incision 5S, sixth incision 6S, and seventh incision 7S, or may have only the fifth incision 5S and the sixth incision 6S. In this case, the medical sheath 20 preferably has an incision 20S extending in the axial direction 20X, as shown in FIG. 5, for example. By inserting the edge of the fifth incision 5S into the lumen 20L through the incision 20S of the medical sheath 20, the lumen 20L side of the medical sheath 20 can be supported, making the medical sheath 20 less likely to deform. Alternatively, a bridge may be formed by the fifth incision 5S and the sixth incision 6S, and the bridge may be inserted into the lumen 20L through the incision 20S of the medical sheath 20 to support the lumen 20L side of the medical sheath 20. The shapes of the fifth incision 5S and the sixth incision 6S may be U-shaped, V-shaped, U-shaped, or S-shaped, respectively. In this case, the shape of the outer edge of the flap formed by the fifth incision 5S may be U-shaped, V-shaped, U-shaped, or S-shaped. The shape of the outer edge of the flap formed by the sixth incision 6S may be U-shaped, V-shaped, U-shaped, or S-shaped. Furthermore, like the third flap 3F and the fourth flap 4F, a flap formed only by the fifth incision 5S and a flap formed only by the sixth incision 6S may be raised to support the medical sheath 20 by pressing it down from above.

[0056] Furthermore, the medical sheath 20 does not necessarily need to be detachably fixed to the base sheet 10 by flaps, bridges, cut edges, or the like formed by incisions in the base sheet 10. For example, the base sheet 10 may have a fixing member, at least one end of which is fixed to the base sheet 10, and the medical sheath 20 may be detachably fixed to the base sheet 10 via the fixing member. For example, the medical sheath 20 can be detachably fixed to the base sheet 10 by inserting at least a portion of the non-fixed portion of the fixing member that is not fixed to the base sheet 10 into the lumen 20L of the medical sheath 20. The fixing member is preferably sheet-shaped or rod-shaped, and more preferably sheet-shaped. The sheet-shaped fixing member supports the lumen 20L side of the medical sheath 20 while facilitating the supply of sterilization gas, such as heated sterilization gas, to the lumen 20L. The fixing member preferably contains the components listed for the resin layer and / or paper layer described above. The base sheet 10 may have two or more fixing members.

[0057] As shown in FIG. 1, the shortest distance from one end of the medical sheath 20 in the axial direction 20X to the first hole 1H is preferably equal to or less than half the length of the medical sheath 20 in the axial direction 20X. This makes it easier to supply sterilizing gas to the medical sheath 20 from the first hole 1H. The shortest distance is more preferably equal to or less than one-third the length of the medical sheath 20 in the axial direction 20X. On the other hand, the shortest distance is more preferably equal to or more than one-tenth the length of the medical sheath 20 in the axial direction 20X. This makes it easier to prevent the medical sheath 20 from unintentionally falling off when removing the medical device 30.

[0058] The medical sheath 20 is preferably positioned farther from the centroid 10C of the base sheet 10 than the medical instrument 30. The sterilizing gas that has passed through the first hole 1H etc. is more likely to move to an area near the outer edge of the packaging bag 40 than to the center thereof due to convection within the packaging bag 40, and therefore, by positioning the medical sheath 20 farther from the centroid 10C, sterilization is facilitated.

[0059] The angle formed between the axial direction 20X of the medical sheath 20 and the longitudinal direction 30X of the medical device 30 is preferably 20 degrees or less. This allows the first hole 1H and the second hole 2H to be easily positioned close to both ends of the medical sheath 20, thereby enabling sterilizing gas to be efficiently supplied to the medical sheath 20 from the first hole 1H etc. The angle is more preferably 10 degrees or less, even more preferably 5 degrees or less, even more preferably 1 degree or less, and most preferably 0 degree.

[0060] The medical sheath 20 is preferably a tube extending in the axial direction 20X. The medical sheath 20 is preferably used to facilitate insertion of a treatment catheter, such as a balloon catheter, microcatheter, or penetration catheter, into a guiding catheter that has already been inserted into the body. The length of the medical sheath 20 in the axial direction 20X 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 to 2.00 times the inner diameter, more preferably 1.02 to 1.50 times, and even more preferably 1.05 to 1.20 times.

[0061] As shown in Fig. 5, the medical sheath 20 preferably has a slit 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 portion 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 via the sheath. In such cases, it is necessary to remove the sheath from the treatment catheter after insertion. However, since the medical sheath 20 has the slit 20S, the medical sheath 20 can be removed by opening the slit 20S. This further makes it easier to attach and detach the medical sheath 20 to and from the sheet 10.

[0062] 5, the medical sheath 20 preferably has an opening 20O at the proximal end that widens from the distal end toward the proximal end and an outer surface. This configuration is a so-called flared shape, and a treatment catheter such as a balloon catheter can be easily inserted through the opening 20O.

[0063] 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, and fluororesins such as polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, and ethylene-tetrafluoroethylene copolymer. These may be used alone or in combination of two or more. The shape of the outer edge of the cross section of the medical sheath 20 in a direction perpendicular to the axial direction 20X of the medical sheath 20 is preferably circular or elliptical, more preferably circular. The shape of the outer edge of the lumen 20L of the cross section of the medical sheath 20 in a direction perpendicular to the axial direction 20X of the medical sheath 20 is preferably circular or elliptical, more preferably circular.

[0064] The medical instrument 30 having the longitudinal direction 30X is preferably a syringe, a dilator, or a torque device, and more preferably a syringe. The syringe preferably has an outer cylinder and a plunger with at least a tip portion disposed inside the outer cylinder. Furthermore, a gasket is preferably provided at the tip portion of the plunger. Furthermore, the outer cylinder preferably has a main body portion and a tip portion connected to the distal end of the main body portion and having an outer diameter smaller than the outer diameter of the main body portion.

[0065] The medical instrument 30 has a tubular portion 30T, and the outer diameter of the tubular portion 30T is preferably larger than the outer diameter of the medical sheath 20. This makes it difficult for the medical sheath 20 to be compressed when the medical instrument sets 101 are stacked. Note that when the medical instrument 30 is a syringe, the tubular portion 30T corresponds to the main body of the outer cylinder of the syringe.

[0066] The length of the longitudinal direction 30X of the medical device 30 is preferably 0.6 to 1.5 times, more preferably 0.8 to 1.3 times, and even more preferably 0.9 to 1.2 times the length of the axial direction 20X of the medical sheath 20. This makes it easier for the first hole portion 1H and the second hole portion 2H to approach both ends of the medical sheath 20, allowing sterilization gas to be efficiently supplied to the medical sheath 20 from the first hole portion 1H, etc.

[0067] As described above, the packaging bag 40 contains the base sheet 10, the medical sheath 20, and the medical device 30. The packaging bag 40 preferably has a lower layer 41 and an upper layer 42. The outer edges of the lower layer 41 and the upper layer 42 are preferably joined together, and more preferably joined along the entire periphery. This makes it easier to maintain the sterilized state of the medical sheath 20, etc. after sterilization.

[0068] The upper layer 42 preferably includes a resin film, and is preferably made of a resin film. The resin film preferably includes a polyethylene layer, a polypropylene layer, an ethylene-vinyl acetate layer, a polyethylene terephthalate layer, a polyamide layer, a vinyl chloride layer, a polyurethane layer, a polystyrene layer, or a laminate thereof, and more preferably includes a polyethylene layer, a polypropylene layer, an ethylene-vinyl acetate layer, a polyethylene terephthalate layer, or a laminate thereof.

[0069] The lower layer 41 preferably includes a nonwoven fabric, a paper layer, or a laminate thereof, more preferably includes a nonwoven fabric or a paper layer, and even more preferably consists of a nonwoven fabric or a paper layer. This allows the lower layer 41 to exhibit breathability. The nonwoven fabric preferably includes polyethylene, polypropylene, polyester, or a mixture thereof. The paper layer preferably includes uncoated paper, Japanese paper, or a laminate thereof. The nonwoven fabric and / or paper layer may be laminated with a perforated resin film.

[0070] The lower layer 41 and the upper layer 42 may be joined at a joint 43 with a heat-sealable resin or with an adhesive.

[0071] As described above, the packaging bag 40 has a ventilation part 40V at a position facing the other surface 10B opposite to the one surface 10A of the base sheet 10. Sterilizing gas can be supplied into the packaging bag 40 through the ventilation part 40V.

[0072] 1, 2, and 3, the lower layer 41 of the packaging bag 40 is formed of a nonwoven fabric, and the portion of the lower layer 41 other than the joint portion 43 corresponds to the ventilation portion 40V. The area ratio of the ventilation portion 4 in the lower layer 41 of the packaging bag 40 is preferably 50 area% or more, more preferably 70 area% or more, and even more preferably 90 area% or more. On the other hand, the area ratio may be 100 area% or less, or may be 95 area% or less.

[0073] As described above, the medical instrument set 101 can be stacked and sterilized by methods such as high-pressure steam sterilization and ethylene oxide gas sterilization.

[0074] A medical instrument according to a second embodiment will be described. Fig. 6 is a plan view of one side of the medical instrument set according to the second embodiment. Fig. 7 is a plan view of the other side of the medical instrument set according to the second embodiment. Fig. 8 is a plan view of the base sheet before the components of Fig. 6 are arranged. Note that detailed description of parts of the medical instrument set according to the second embodiment that overlap with the medical instrument set according to the first embodiment will be omitted.

[0075] As shown in FIGS. 6 and 7 , a medical instrument set 102 according to the second embodiment includes a base sheet 10, a medical sheath 20 having an axial direction 20X that is detachably fixed to one surface 10A of the base sheet 10, a medical instrument 30 having a longitudinal direction 30X that is detachably fixed to one surface 10A of the base sheet 10, and a packaging bag 40 that contains the base sheet 10, the medical sheath 20, and the medical instrument 30.

[0076] The medical instrument set 102 further includes a medical elongated body 50 and a protective tube 60 in which at least a portion of the medical elongated body 50 is disposed, and the protective tube 60 is removably fixed to one surface 10A of the base sheet 10 in a wound state, and it is preferable that the medical sheath 20 and the medical instrument 30 are disposed inside the wound protective tube 60. Even when medical instrument sets 102 are stacked, the wound protective tube 60 protects the medical sheath 20 and makes it less likely to deform.

[0077] The shape of the outer edge of the cross section of the protective tube 60 in the thickness direction is preferably a circle, an ellipse, a polygon, a rounded polygon, or a combination thereof, more preferably a circle, an ellipse, or a rounded polygon, even more preferably a circle or an ellipse, and even more preferably a circle. The shape of the outer edge of the lumen of the cross section of the protective tube 60 in the thickness direction is preferably a circle, an ellipse, a polygon, a rounded polygon, or a combination thereof, more preferably a circle, an ellipse, or a rounded polygon, even more preferably a circle or an ellipse, and even more preferably a circle. The protective tube 60 may contain a polyolefin resin such as polyethylene, polypropylene, an ethylene-propylene copolymer, or an ethylene-vinyl acetate copolymer, a polyvinyl chloride resin, a polystyrene resin, a polyamide resin, a polyimide resin, or a mixture thereof.

[0078] The outer diameter of the protective tube 60 is preferably larger than the outer diameter of the medical sheath 20. This makes it difficult for the medical sheath 20 to deform when multiple medical instrument sets 102 are stacked. Note that these outer dimensions are the outer diameter in the thickness direction.

[0079] The elongated medical body 50 is preferably a balloon catheter, a microcatheter, or a penetration catheter, and more preferably a balloon catheter. The elongated medical body 50 preferably has a handle portion at the proximal end. The protective tube 60 may be any tube that allows at least a portion of the elongated medical body 50 to be placed inside. The shape of the protective tube 60 is preferably fixed in a wound state by a plurality of clips.

[0080] The base sheet 10 preferably has a pair of flaps 8F formed by a pair of cuts 8S and a pair of holes 8H formed by the pair of flaps 8F standing up, and the pair of flaps 8F detachably fix the protective tube 60. Since the base sheet 10 has a pair of holes 8H, sterilizing gas can be supplied to the medical sheath 20 through the holes 8H.

[0081] It is preferable that the angle formed by the imaginary line connecting the centers of the pair of flaps 8F and the axial direction 20X of the medical sheath 20 is 10 degrees or less. This makes it easier for the pair of holes 8H to approach both ends of the medical sheath 20, allowing sterilizing gas to be efficiently supplied to the medical sheath 20 from the pair of holes 8H.

[0082] The medical sheath 20 is preferably located outside a region 8R extending from one incision 8S1 of the pair of incisions 8S to the other incision 8S2. The region 8R is prone to deformation when the protective tube 60 is attached or detached, so by locating the medical sheath 20 in a region outside this region 8R, it becomes easier to prevent the medical sheath 20 from becoming detached at an unintended time. Conversely, it becomes easier to prevent the protective tube 60 from becoming detached at an unintended time when the medical sheath 20 is attached or detached.

[0083] Each of the pair of flaps 8F preferably extends in a direction toward the outside of the base sheet 10. This makes it easier for each flap 8F to hold the wound protective tube 60.

[0084] 6 and 8, at the outer edge of the base sheet 10, there may be a vertex T1 that is located closer to the centroid 10C than the other vertices T2, T3, and T4 among the vertices T1, T2, T3, and T4. This makes it possible to secure a wide area for the joint 43 of the packaging bag 40 adjacent to the vertex T1, making it easier to open the packaging bag 40 from that area.

[0085] Although not shown, the medical instrument sets 101 and 102 may each have other components detachably fixed to one side 10A of the base sheet 10. The other components are preferably detachably fixed to an area of ​​one side 10J of the base sheet 10. Examples of other components include a mandrel, a guidewire, a needle, a dilator, a rewrapper, a torquer, a stopcock, an adapter, etc. The base sheet 10 may have other incisions, other flaps formed by the other incisions, and other holes formed by the erection of the other flaps. The other components are preferably supported by the other flaps. [Explanation of symbols]

[0086] 1F 1st flap 1H 1st hole 1P through hole 1S First cutting 2F 2nd flap 2S Second cut 3F 3rd flap 2H 2nd hole 3S Third cut 4F 4th flap 4S 4th cut 5F 5th flap 5H 5th hole 5S 5th cut 5S0 Straight section 5S1 1st slope section 5S2 2nd slope part 6F 6th flap 6H 6th hole 6S 6th cut 6S0 Straight section 6S1 1st slope section 6S2 2nd slope part 7S 7th cut 8F Pair of flaps 8H Pair of holes 8R area 8S Pair of notches 8S1 One-sided cut 8S2 Other cut 10 Base sheet 10A One side 10B Other side 10C centroid 10D Imaginary Line 10J One-sided area 10K other side area 10L long diameter 10M Short diameter 20 Medical sheath 20L lumen 20O opening 20S Cutting 20X Axial 30 Medical equipment 30T cylindrical part 30X Longitudinal 40 packaging bags 40V Ventilation 41 Lower layer 42 Upper layer 43 Joint 50 Medical long body 60 Protection tube 101, 102 Medical Instrument Set

Claims

1. A base sheet; a medical sheath having an axial direction detachably fixed to one side of the base sheet; a medical device having a longitudinal direction and detachably fixed to the one surface side of the base sheet; a packaging bag containing the base sheet, the medical sheath, and the medical device, the base sheet has a first flap formed by a first cut and a first hole formed by the first flap standing up, the first flap supporting the medical device, the medical sheath and the medical device are disposed in one region of one side and the other side defined by an imaginary line passing through the centroid of the base sheet, The major axis of the base sheet is equal to or less than twice the minor axis, The packaging bag has a ventilation part at a position facing the other side of the base sheet opposite to the one side.

2. The medical instrument set according to claim 1 , wherein the length of the minor axis of the first hole is greater than the outer diameter of the medical sheath.

3. 3. The medical instrument set according to claim 1, wherein the shortest distance from one end of the medical sheath in the axial direction to the first hole is equal to or less than half the length of the medical sheath in the axial direction.

4. 3. The medical instrument set according to claim 1, wherein the medical sheath is disposed at a position farther from the centroid of the base sheet than the medical instrument.

5. 3. The medical instrument set according to claim 1, wherein the angle formed between the axial direction of the medical sheath and the longitudinal direction of the medical instrument is 20 degrees or less.

6. The medical instrument set according to claim 1 or 2, wherein the medical instrument has a tubular portion, and the outer diameter of the tubular portion is larger than the outer diameter of the medical sheath.

7. The medical instrument set according to claim 6 , wherein the first flap supports the tubular portion.

8. 3. The medical instrument set according to claim 1, wherein the base sheet has a second flap formed by a second incision and a second hole formed by the standing of the second flap, and the second flap supports the medical instrument.

9. 3. The medical instrument set according to claim 1 or 2, further comprising a medical elongated body and a protective tube in which at least a portion of the medical elongated body is disposed, the protective tube being removably fixed to the one surface side of the base sheet in a wound state, and the medical sheath and the medical instrument being disposed inside the wound protective tube.

10. The medical instrument set according to claim 9, wherein the base sheet has a pair of flaps formed by a pair of cuts and a pair of holes formed by the pair of flaps standing up, and the pair of flaps detachably fix the protective tube.

11. The medical instrument set according to claim 10, wherein the medical sheath is located outside the area extending from one of the pair of notches to the other of the pair of notches.

12. The medical instrument set according to claim 9, wherein the outer diameter of the protective tube is larger than the outer diameter of the medical sheath.

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