JP2023172185A - Medical tool - Google Patents

Abstract

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

Description

The present invention relates to a medical device that reduces deformation of a medical sheath due to sterilization.

Conventionally, flexible long medical instruments such as catheters have often been fixed to a mount and packaged in a bag when not in use. For example, Patent Document 1 discloses a medical device holding mount made of a long sheet material, which is stored in a bag-like package while holding a medical device having a flexible linear portion. The holding part is formed by bending the sheet material into a V-shape along the longitudinal direction of the sheet material, and the holding part is formed by bending the sheet material into a V-shape for storing the linear part of the medical device. A medical device holding mount is disclosed that has a groove and a W-shaped groove formed at the base end of the V-shaped groove by folding the trough in the opposite direction into a mountain shape. Furthermore, Patent Document 2 discloses that a thin flat plate or plate-shaped body made of paper or soft synthetic resin is cut to form one or more restraining pieces, and one end of the restraining piece is arched approximately in the center. A medical device package characterized in that a certain notch is provided, a pressure relief part is formed by cutting from the arched end of the notch to the end of the restraining piece, and the restraining piece is bent at a bending part from the proximal end thereof. A member is disclosed.

JP2009-201826A Japanese Patent Application Publication No. 2002-193322

Conventionally, elongated medical instruments have often been fixed to a mount and sterilized while being packaged in a bag, as in Patent Documents 1 and 2. For sterilization, a method of sterilizing in a heated environment using high-pressure steam, heated sterilizing gas, etc. was adopted, but for example, in the case of a medical sheath, heating the medical sheath while it is held down by the holding part of the mount There were cases where the medical sheath was deformed. 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 deformation of a medical sheath during sterilization.

A medical device according to an embodiment of the present invention that can solve the above problems is as follows.
[1] A base sheet, a medical sheath, and a first fixing member that is at least partially disposed in the inner cavity of the medical sheath and removably fixes the medical sheath to the base sheet. medical equipment.

As described above, since at least a portion of the first fixing member is disposed in the lumen of the medical sheath, the lumen side of the medical sheath can be supported, thereby reducing deformation of the medical sheath. be able to.

The medical device according to the embodiment is preferably one of the following [2] to [16].
[2] The first fixing member according to [1], wherein the first fixing member has a first fixing part that extends in a first direction and is fixed to the base sheet at one end in the first direction. Medical equipment.
[3] Further, the second fixing member extends in the second direction, at least a part of which is disposed in the inner cavity of the medical sheath, and detachably fixes the medical sheath to the base sheet; The second fixing member has a second fixing part fixed to the base sheet at one end in the second direction,
The medical device according to [2], wherein the other end of the second fixing member in the second direction faces the other end of the first fixing member in the first direction.
[4] The first fixing member has a first widened part that increases in width toward the first fixing part in a portion adjacent to the first fixing part,
The medical device according to [3], wherein the second fixing member has a second widened portion that increases in width toward the second fixing portion in a portion adjacent to the second fixing portion.
[5] The first fixing member has a first constant width portion having a constant width in a portion adjacent to the first widened portion,
The medical device according to [4], wherein the second fixing member has a second constant width portion having a constant width in a portion adjacent to the second widened portion.
[6] The first fixing member and the second fixing member each have a non-fixed part that is not fixed to the base sheet, and each of the non-fixed parts has at least a part of the medical sheath. The medical device according to any one of [3] to [5], which is placed in the internal cavity.
[7] The medical treatment according to [6], wherein the length of the non-fixed part of the first fixing member in the first direction is longer than the length of the non-fixing part of the second fixing member in the second direction. Tools.
[8] The medical device according to [6] or [7], wherein the non-fixing portion of the first fixing member and the non-fixing portion of the second fixing member each have a flap shape.
[9] The medical device according to any one of [3] to [8], wherein the first fixing member and the second fixing member are not in contact with each other.
[10] The medical treatment according to [2], wherein the first fixing member has a second fixing part fixed to the base sheet at the other end of the first fixing member in the first direction. Tools.
[11] The width of the portion of the first fixing member disposed in the inner cavity of the medical sheath is smaller than the diameter of the inner cavity of the medical sheath according to any one of [1] to [10]. Medical equipment.
[12] The width of the portion of the second fixing member disposed in the inner cavity of the medical sheath is smaller than the diameter of the inner cavity of the medical sheath according to any one of [3] to [9]. Medical equipment.
[13] The medical device according to any one of [1] to [12], wherein the first fixing member is sheet-shaped.
[14] The medical device according to any one of [3] to [9], wherein the second fixing member has a sheet shape.
[15] The medical device according to any one of [1] to [14], wherein the medical sheath has a notch extending in the axial direction.
[16] The medical device according to [15], wherein at least a portion of the first fixing member is sandwiched between the notches of the medical sheath.

According to the present invention, it is possible to provide a medical device that can reduce deformation of a medical sheath due to sterilization.

FIG. 1 is a plan view of a medical device according to a first embodiment. FIG. 2 is a cross-sectional view taken along the line AA in FIG. FIG. 3 is a plan view of the sheet before the medical sheath of FIG. 1 is placed thereon. FIG. 4 is a plan view of an example of a medical sheath. FIG. 5 is a plan view of the medical device according to the second embodiment. FIG. 6 is a plan view of the sheet before the medical sheath of FIG. 5 is placed thereon. FIG. 7 is a plan view of the medical device according to the third embodiment. FIG. 8 is a cross-sectional view taken along the line BB in FIG. FIG. 9 is a plan view of the sheet before the medical sheath of FIG. 7 is placed thereon. FIG. 10 is a cross-sectional view of a modification of the BB cross section in FIG.

In the following, the present invention will be explained in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and may be modified as appropriate within the scope that fits the spirit of the above and below. Of course, it is also possible to implement in addition, and all of them are included in the technical scope of the present invention. In addition, in each drawing, member numbers etc. may be omitted for convenience, but in such a case, the specification and other drawings shall be referred to. Further, the dimensions of various members in the drawings are given priority to help understanding the features of the present invention, and therefore may differ from actual dimensions.

A medical device according to an embodiment of the present invention includes a base sheet, a medical sheath, and a first member that is at least partially disposed in the inner cavity of the medical sheath and removably fixes the medical sheath to the base sheet. A fixing member.

As described above, conventionally, when heat sterilization using high pressure steam, heat sterilization gas, etc. is performed while the medical sheath is held down by the holding portion of the mount, the medical sheath may be deformed. On the other hand, according to the medical device according to the embodiment, at least a portion of the first fixing member is disposed in the lumen of the medical sheath, so that the lumen side of the medical sheath can be supported. Therefore, deformation of the medical sheath can be reduced.

Below, a medical device according to a first embodiment will be described with reference to FIGS. 1, 2, and 3. FIG. 1 is a plan view of a medical device according to a first embodiment. FIG. 2 is a cross-sectional view taken along the line AA in FIG. FIG. 3 is a plan view of the sheet before the medical sheath of FIG. 1 is placed thereon. FIG. 4 is a plan view of an example of a medical sheath.

As shown in FIGS. 1 and 2, a medical device 101 according to the first embodiment includes a base sheet 10, a medical sheath 20, and at least a portion of which is disposed in a lumen 20L of the medical sheath 20. The first fixing member 1 detachably fixes the sheath 20 to the base sheet 10. By arranging at least a portion of the first fixing member 1 in the lumen 20L of the medical sheath 20, the lumen 20L side of the medical sheath 20 can be supported. Deformation of the medical sheath 20 can be reduced.

As shown in FIGS. 1 and 3, the first fixing member 1 preferably extends linearly in the first direction 1X. This makes it easier for the first fixing member 1 to support the lumen 20L side of the medical sheath 20 that extends linearly.

As shown in FIGS. 1 and 3, the first fixing member 1 has a first fixing part 1C that extends in the first direction 1X and is fixed to the base sheet 10 at one end 1A in the first direction 1X. It is preferable that you do so. Furthermore, it is preferable that the first fixing member 1 has a non-fixing portion 1F that is not fixed to the base sheet 10. By arranging at least a portion of the non-fixing portion 1F of the first fixing member 1 in the inner cavity 20L of the medical sheath 20, the medical device 101 is indirectly and removably fixed to the base sheet 10. be able to.

In the first fixing part 1C, it is sufficient that the first fixing member 1 is fixed to the base sheet 10, and the fixing mode is, for example, a mode in which the first fixing member 1 is welded to the base sheet 10. , a mode in which they are bonded with an adhesive, a pressure-sensitive adhesive, etc., and a hole or a convex portion provided in the first fixing member 1 and a convex portion or hole provided in the base sheet 10 fit together. Examples include aspects.

The shape of the first fixing portion 1C in plan view is not particularly limited, and examples thereof include a circle, an ellipse, a polygon, and a rounded polygon.

It is preferable that the non-fixed portion 1F of the first fixing member 1 extends linearly in the first direction 1X. This makes it easier for the first fixing member 1 to support the lumen 20L side of the medical sheath 20 that extends linearly.

As shown in FIG. 2, at least a portion of the outer edge of the first fixing member 1 in the first direction 1X is preferably in contact with the inner surface of the medical sheath 20. This makes it difficult for the medical sheath 20 to deform.

As shown in FIG. 1, the length of the non-fixed portion 1F of the first fixing member 1 in the first direction 1X is 1.00 times or more and 1.20 times or less the length of the medical sheath 20 in the axial direction 20X. It is preferably 1.02 times or more and 1.10 times or less. Thereby, the medical sheath 20 can be made difficult to deform as a whole.

As shown in FIGS. 1 and 3, the first fixing member 1 has a fixing portion fixed to the base sheet 10 in a region closer to the other end 1B than the first fixing portion 1C in the first direction 1X. It is preferable that it does not have. Thereby, the non-fixing portion 1F of the first fixing member 1 can be easily placed in the inner cavity 20L of the medical sheath 20.

It is preferable that the non-fixed portion 1F of the first fixing member 1 has a flap shape. Thereby, the non-fixed portion 1F of the first fixing member 1 can be easily moved, so that the medical sheath 20 can be easily attached to and detached from the base sheet 10.

It is preferable that the first fixing member 1 has a first widened portion that increases in width toward the first fixing portion 1C in a portion adjacent to the first fixing portion 1C. Further, it is preferable that the first fixing member 1 has a first constant width portion having a constant width in a portion adjacent to the first widened portion. For details of the first widened portion and the first constant width portion, refer to the first widened portion 1D and the first constant width portion 1E of the medical device 102 according to the second embodiment described later.

The first fixing member 1 is preferably sheet-shaped or rod-shaped, and more preferably sheet-shaped. By being sheet-like, it is possible to support the lumen 20L side of the medical sheath 20 and facilitate supply of sterilizing gas such as heated sterilization gas to the lumen 20L.

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

When the first fixing member 1 is a sheet, the outer edge of the sheet extending in the first direction 1X is preferably linear, but may be arcuate, wavy, or other non-linear. The sheet 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, two or more resin layers, and two or more paper layers.

As the resin layer, a polyolefin layer, a fluororesin layer, a polyester layer, a polyurethane layer, a polystyrene layer, a polycarbonate layer, a silicone layer, a polyamide layer, a polyimide layer are preferable, a polyolefin layer and a fluororesin layer are more preferable, and a polyolefin layer is even more preferable. preferable. This makes it easier for the first fixing member 1 to hold the medical sheath 20. These may be used alone or in combination of two or more. 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. Preferably, the polyester layer comprises polyethylene terephthalate, polybutylene terephthalate, or a mixture thereof. Preferably, the polyurethane layer contains polyurethane. Preferably, the polystyrene layer contains polystyrene. Preferably, the polycarbonate layer contains polycarbonate. It is preferable that the silicone resin layer contains silicone resin. Preferably, the polyamide layer includes nylon. Preferably, the polyimide layer contains polyetherimide.

As the paper layer, wood-free paper, medium-quality paper, kraft paper, single-gloss kraft paper, and latex-impregnated paper are preferable. These may be used alone or in combination of two or more.

The thickness of the sheet 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 0.2 mm or more and 0.8 mm or less. More preferred. This makes it easier for the first fixing member 1 to support the lumen 20L side of the medical sheath 20, and makes it easier to supply sterilization gas such as heated sterilization gas to the lumen 20L.

When the first fixing member 1 is a rod, the shape of the rod is preferably a cylinder, a polygonal prism, or a polygonal prism with rounded corners, more preferably a polygonal prism, and still more preferably a quadrangular prism. preferable. Thereby, the first fixing member 1 can support the lumen 20L side of the medical sheath 20 while making it easier to supply sterilizing gas such as heated sterilization gas to the lumen 20L. Further, a lumen may be formed near the central axis of the rod. That is, the rod may be a hollow body. The hollow body may have a through hole penetrating into the inner cavity from the inner surface. The rod preferably contains the components listed above for the resin layer and/or paper layer.

As shown in FIG. 2, the width of the portion of the first fixing member 1 disposed in the inner cavity 20L of the medical sheath 20 is preferably smaller than the diameter of the inner cavity 20L of the medical sheath 20. Thereby, the first fixing member 1 can be easily inserted into and removed from the inner cavity 20L of the medical sheath 20. The width is preferably at most 0.95 times the diameter, more preferably at most 0.90 times the diameter. On the other hand, the width is preferably 0.70 times or more the diameter, more preferably 0.80 times or more the diameter. Such a first fixing member 1 can easily support the inner cavity 20L side of the medical sheath 20. Note that the diameter of the lumen refers to a virtual line segment that passes through the center of the lumen 20L and has both end points on the outer edge of the lumen 20L in a cross section perpendicular to the axial direction 20X of the medical sheath 20. It is the longest virtual line segment of . Note that when the medical sheath 20 has a cut 20S, which will be described later, the outer edge of the cut 20S is not included in the outer edge of the inner cavity 20L.

The area of the region surrounded by the outer edge of the base sheet 10 in plan view is preferably 50 cm ² or more and 1000 cm ² or less, more preferably 300 cm ² or more and 600 cm ² or less. The shape of the base sheet 10 in 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 a quadrilateral or a rounded polygon. More preferably, it is square. When the shape of the base sheet 10 is a polygon or a rounded polygon, the lengths of the virtual line segments connecting the centroid of the base sheet 10 and each vertex may all be the same; There may be at least one virtual line segment shorter than the line segment. 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 0.2 mm or more and 0.8 mm or less. It is even more preferable that there be. This makes the base sheet 10 easier to handle.

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, two or more resin layers, and two or more paper layers. The base sheet 10 and the first fixing member 1 preferably have the same layer, more preferably the same layer. Regarding the resin layer and the paper layer, refer to the description of the sheet of the first fixing member 1 described above.

Although not shown, the base sheet 10 may have a cut extending in the first direction 1X in a portion where the medical sheath 20 is arranged. The shape of the cut is preferably linear. Due to the cut, when pressure is applied to the medical sheath 20, the pressure can be relieved or at least a portion of the medical sheath 20 can be moved downward, so that the medical sheath 20 becomes difficult to deform. Thereby, a plurality of medical instruments 101 can be stacked to facilitate sterilization. The length of the cut in the first direction 1X is preferably 0.5 times or more, more preferably 0.8 times or more, the length of the non-fixed portion 1F in the first direction 1X, and 0. It is more preferably 9 times or more, and most preferably 1.0 times. The width of the cut is preferably greater than or equal to the width of the non-fixed portion 1F and smaller than the outer diameter of the medical sheath 20. This makes it easier to exhibit the above-mentioned pressure relief effect, and also makes it easier for the base sheet 10 to support the medical sheath 20.

As shown in FIG. 1, 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 penetrating catheter, into a guiding catheter previously 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 1.0 mm or more and 2.0 mm or less. More preferably. The outer diameter of the medical sheath 20 is preferably 1.01 times or more and 2.00 times or less, more preferably 1.02 times or more and 1.50 times or less, and 1.05 times the inner diameter. More preferably, it is 1.30 times or less.

As shown in FIG. 4, the medical sheath 20 preferably has a cut 20S extending in the axial direction 20X. Depending on the treatment area, when inserting a treatment catheter such as a balloon catheter into the body, the distal part of the sheath is inserted into the proximal end of the guiding catheter, and the treatment is inserted into the guiding catheter through the sheath. A special catheter may be inserted. In such a case, it is necessary to remove the sheath from the treatment catheter after the insertion, but since the medical sheath 20 has the cut 20S, the medical sheath 20 can be removed by opening the cut 20S. . Furthermore, the cut 20S allows the medical sheath 20 to be easily attached to and detached from the base sheet 10.

As shown in FIG. 4, the medical sheath 20 preferably has an outer surface and an opening 20O that widens from the distal end toward the proximal end at the proximal end. This configuration has a so-called flared shape, and a treatment catheter such as a balloon catheter can be easily inserted through the opening 20O.

The medical sheath 20 preferably contains resin, and more preferably consists of resin. Examples of resins include polyolefin resins such as polypropylene and polyethylene, polyester resins such as polyethylene terephthalate, polyamide resins such as nylon, aromatic polyetherketone resins such as polyetheretherketone, polyimide resins, polytetrafluoroethylene, and tetrafluoroethylene. Examples include fluororesins such as ethylene-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 the direction perpendicular to the axial direction 20X of the medical sheath 20 is preferably circular or elliptical, and more preferably circular. Further, the shape of the outer edge of the inner cavity 20L in 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 oval, and more preferably circular.

Although not shown, the medical device 101 may further include a packaging bag that encloses the sheet 10, the medical sheath 20, and the first fixing member 1. This makes it easier to maintain the sterile state of the medical sheath 20 and the like after sterilization. Examples of the sterilization treatment include high pressure steam sterilization, ethylene oxide gas sterilization, and the like.

Below, a medical device according to a second embodiment will be described with reference to FIGS. 5 and 6. FIG. 5 is a plan view of the medical device according to the second embodiment. FIG. 6 is a plan view of the sheet before the medical sheath of FIG. 5 is placed thereon. Note that, regarding the medical device according to the second embodiment, a detailed explanation of the parts that overlap with the medical device according to the first embodiment will be omitted.

As shown in FIGS. 5 and 6, the medical device 102 according to the second embodiment includes a base sheet 10, a medical sheath 20, and a medical device at least partially disposed in the inner cavity 20L of the medical sheath 20. The first fixing member 1 detachably fixes the sheath 20 to the base sheet 10. The first fixing member 1 preferably has a first fixing part 1C that extends in the first direction 1X and is fixed to the base sheet 10 at one end 1A in the first direction 1X.

As shown in FIGS. 5 and 6, the medical device 102 further extends in the second direction 2X, and is at least partially disposed in the lumen 20L of the medical sheath 20, so that the medical sheath 20 is attached to the base sheet 10. It has a second fixing member 2 that is detachably fixed, and the second fixing member 2 has a second fixing part 2C fixed to the base sheet 10 at one end 2A in the second direction 2X, The other end 2B of the second fixing member 2 in the second direction 2X preferably faces the other end 1B of the first fixing member 1 in the first direction 1X. The medical sheath 20 can be indirectly fixed to the base sheet 10 from both sides in the axial direction 20X by the first fixing member 1 and the second fixing member 2 facing each other in this way. It can be made difficult to move in the direction 20X.

The first fixing member 1 and the second fixing member 2 have non-fixed parts 1F and 2F, respectively, which are not fixed to the base sheet 10, and each of the non-fixed parts 1F and 2F has at least a part that is used for medical treatment. It is preferable that the inner lumen 20L of the sheath 20 is disposed. Since the non-fixed portion 1F of the first fixing member 1 and the non-fixed portion 2F of the second fixing member 2 can be moved independently, it is possible to attach and detach the medical sheath 20 to and from the base sheet 10. It can be made easier.

It is preferable that the non-fixed portion 1F of the first fixing member 1 and the non-fixed portion 2F of the second fixing member 2 each have a flap shape. Since the non-fixed portion 1F of the first fixing member 1 and the non-fixed portion 2F of the second fixing member 2 are easily movable independently, it is possible to easily attach and detach the medical sheath 20 to and from the base sheet 10. can.

As shown in FIGS. 5 and 6, the first fixing member 1 has a fixing portion fixed to the base sheet 10 in a region closer to the other end 1B than the first fixing portion 1C in the first direction 1X. The second fixing member 2 has a fixing part fixed to the base sheet 10 in a region closer to the other end 2B than the second fixing part 2C in the second direction 2X. Preferably, it does not. In such a configuration, the non-fixed part 1F of the first fixing member 1 and the non-fixed part 2F of the second fixing member 2 are easily movable independently, making it easy to attach and detach the medical sheath 20 to the base sheet 10. be able to.

As shown in FIG. 6, the first direction 1X and the second direction 2X are preferably parallel. This makes it easier to support the inner cavity 20L side of the medical sheath 20 as a whole by the first fixing member 1 extending in the first direction 1X and the second fixing member 2 extending in the second direction 2X. Parallel means that the angle between the first direction 1X and the second direction 2X is 5 degrees or less. The angle is more preferably 3 degrees or less, still more preferably 2 degrees or less, and most preferably 0 degrees.

As shown in FIGS. 5 and 6, the first fixing member 1 has a first widened portion 1D that increases in width toward the first fixing portion 1C in a portion adjacent to the first fixing portion 1C. , it is preferable that the second fixing member 2 has a second widened portion 2D whose width increases toward the second fixing portion 2C in a portion adjacent to the second fixing portion 2C. Since the first widened portion 1D and the second widened portion 2D can relieve the force applied to both ends of the medical sheath 20 in the axial direction 20X, both ends of the medical sheath 20 are less likely to be damaged. This also makes it difficult for the medical sheath 20 to move in the axial direction 20X. The first widened portion 1D is preferably located closer to the other end portion 1B than the first fixed portion 1C in the first direction 1X. Further, the second widened portion 2D is preferably located closer to the other end portion 2B than the second fixing portion 2C in the second direction 2X. It is preferable that the outer edges of the first widened portion 1D and the second widened portion 2D are each linear. This allows the first widened portion 1D and the second widened portion 2D to be tapered, making both ends of the medical sheath 20 more difficult to damage. Note that the outer edges of the first widened portion 1D and the second widened portion 2D may each have a non-linear shape such as an arc shape or a wave shape.

As shown in FIGS. 5 and 6, the first fixing member 1 has a first constant width portion 1E having a constant width in a portion adjacent to the first widened portion 1D, and the second fixing member 2 has a first constant width portion 1E having a constant width in a portion adjacent to the first widened portion 1D. It is preferable to have a second constant width portion 2E having a constant width in a portion adjacent to the second widened portion 2D. Thereby, the first fixing member 1 and the second fixing member 2 can easily support the lumen 20L side of the medical sheath 20 as a whole. The first constant width portion 1E is preferably located closer to the other end portion 1B than the first widened portion 1D in the first direction 1X. Further, the second constant width portion 2E is preferably located closer to the other end portion 2B than the second widened portion 2D in the second direction 2X. It is preferable that the first constant width portion 1E extends in the first direction 1X. Furthermore, it is preferable that the second widened portion 2D extends in the second direction 2X.

As shown in FIGS. 5 and 6, the length of the non-fixed part 1F of the first fixing member 1 in the first direction 1X is longer than the length of the non-fixed part 2F of the second fixing member 2 in the second direction 2X. is preferred. With this, for example, after inserting the non-fixing part 1F of the first fixing member 1 and the non-fixing part 2F of the second fixing member 2 into the inner cavity 20L of the medical sheath 20 and heat sterilizing them, the length in the extending direction By first removing the non-fixing portion 2F of the second fixing member 2 with a shorter length, the non-fixing portion 1F of the first fixing member 1, which has a longer length in the extending direction, can be smoothly removed. Furthermore, in the case of the medical sheath 20 shown in FIG. 4, the non-fixed part 2F of the second fixing member 2 having a short length in the extending direction is inserted into the opening 20O, and extends to the opening on the opposite side of the opening 20O. It is preferable that the non-fixed portion 1F of the first fixing member 1 is inserted, which has a long length in the direction of extension. Thereby, the medical sheath 20 can be easily removed from the base sheet 10.

The length of the non-fixed part 1F of the first fixing member 1 in the first direction 1X is 1.1 times or more and 2.0 times or less the length of the non-fixed part 2F of the second fixing member 2 in the second direction 2X. It is preferably 1.2 times or more and 1.8 times or less, and even more preferably 1.3 times or more and 1.5 times or less. Thereby, stable fixation of the medical sheath 20 and ease of attachment and detachment can be achieved at the same time.

As shown in FIGS. 5 and 6, it is preferable that the first fixing member 1 and the second fixing member 2 are not in contact with each other. This prevents pressure from the inner cavity 20L of the medical sheath 20 due to contact between the tips of the first fixing member 1 and the second fixing member 2, for example, when the base sheet 10 is curved as a whole. It can be easily avoided.

The shortest distance between the first fixing member 1 and the second fixing member 2 is preferably longer than the thickness of the first fixing member 1 or longer than the thickness of the second fixing member 2. This makes it difficult for the tips of the first fixing member 1 and the second fixing member 2 to come into contact when the base sheet 10 is curved as a whole. The shortest distance between the first fixing member 1 and the second fixing member 2 is at least 1.5 times the thickness of the first fixing member 1 or at least 1.5 times the thickness of the second fixing member 2. It is more preferable that there be. On the other hand, the shortest distance between the first fixing member 1 and the second fixing member 2 is preferably at most 10 times the thickness of the first fixing member 1 or at most 10 times the thickness of the second fixing member 2, More preferably, the thickness is 5 times or less the thickness of the first fixing member 1 or 5 times or less the thickness of the second fixing member 2. Thereby, the first fixing member 1 and the second fixing member 2 can easily support the lumen 20L side of the medical sheath 20 as a whole.

For other details of the first fixing member 1, refer to the description of the first fixing member 1 of the medical device 101 according to the first embodiment. The second fixing member 2 will be explained in detail below.

In the second fixing portion 2C, it is sufficient that the second fixing member 2 is fixed to the base sheet 10, and examples of the fixing mode include, for example, a mode in which the second fixing member 2 is welded to the base sheet 10, A mode in which they are bonded with an adhesive, a pressure-sensitive adhesive, etc., and a mode in which a hole or a convex portion provided in the second fixing member 2 and a convex portion or hole provided in the base sheet 10 fit together. etc.

The shape of the second fixing portion 2C in plan view is not particularly limited, and examples thereof include a circle, an ellipse, a polygon, and a rounded polygon.

It is preferable that the non-fixed portion 2F of the second fixing member 2 extends linearly in the second direction 2X. This makes it easier for the second fixing member 2 to support the lumen 20L side of the medical sheath 20 that extends linearly.

It is preferable that at least a portion of the outer edge of the second fixing member 2 in the second direction 2X is in contact with the inner surface of the medical sheath 20. This makes it difficult for the medical sheath 20 to deform.

The width of the portion of the second fixing member 2 disposed in the inner cavity 20L of the medical sheath 20 is preferably smaller than the diameter of the inner cavity 20L of the medical sheath 20. Thereby, the second fixing member 2 can be easily inserted into and removed from the inner cavity 20L of the medical sheath 20. The width is preferably at most 0.95 times the diameter, more preferably at most 0.90 times the diameter. On the other hand, the distance is preferably 0.70 times or more the diameter, more preferably 0.80 times or more the diameter. Such a second fixing member 2 can easily support the inner cavity 20L side of the medical sheath 20.

The second fixing member 2 is preferably sheet-shaped or rod-shaped, and more preferably sheet-shaped. By being sheet-like, it is possible to support the lumen 20L side of the medical sheath 20 and facilitate supply of sterilizing gas such as heated sterilization gas to the lumen 20L.

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

When the second fixing member 2 is a sheet extending in the second direction 2X, the outer edge of the sheet in the second direction 2X is preferably linear, but may not have a non-linear shape such as an arc or a wave. It's okay. The sheet 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, two or more resin layers, and two or more paper layers. Regarding the resin layer and the paper layer, refer to the description of the sheet of the first fixing member 1 described above. Note that the first fixing member 1 and the second fixing member 2 preferably have the same layer, more preferably the same layer. Moreover, it is preferable that the first fixing member 1 and the second fixing member 2 are sheets.

The thickness of the sheet 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 0.2 mm or more and 0.8 mm or less. More preferred. This makes it easier for the second fixing member 2 to support the inner cavity 20L side of the medical sheath 20, and makes it easier to supply sterilizing gas such as heated sterilized gas to the inner cavity 20L.

When the second fixing member 2 is a rod, the shape of the rod is preferably a cylinder, a polygonal prism, or a rounded polygonal prism, more preferably a polygonal prism, and still more preferably a quadrangular prism. preferable. Thereby, the second fixing member 2 can support the lumen 20L side of the medical sheath 20 while making it easier to supply sterilizing gas such as heated sterilization gas to the lumen 20L. Further, a lumen may be formed near the central axis of the rod. That is, the rod may be a hollow body. The hollow body may have a through hole penetrating into the inner cavity from the inner surface. The rod preferably contains the components listed above for the resin layer and/or paper layer.

Although not shown, the base sheet 10 may have a notch in the portion where the medical sheath 20 is placed. The shape of the cut is preferably linear. Due to the cut, when pressure is applied to the medical sheath 20, the pressure can be relieved or at least a portion of the medical sheath 20 can be moved downward, so that the medical sheath 20 becomes difficult to deform. Thereby, a plurality of medical instruments 102 can be stacked to facilitate sterilization. The length of the cut in the extending direction is preferably 0.5 times or more of the total length of the non-fixed portion 1F in the first direction 1X and the length of the non-fixed portion 2F in the second direction 2X, and It is more preferably .8 times or more, even more preferably 0.9 times or more, and even more preferably 1.0 times or more. On the other hand, the magnification may be 1.2 times or less, or may be 1.1 times or less. The width of the cut is preferably greater than or equal to the width of the non-fixed portion 1F, greater than the width of the non-fixed portion 2F, and smaller than the outer diameter of the medical sheath 20. This makes it easier to exhibit the above-mentioned pressure relief effect, and also makes it easier for the base sheet 10 to support the medical sheath 20.

Below, a medical device according to a third embodiment will be described with reference to FIGS. 7, 8, 9, and 10. FIG. 7 is a plan view of the medical device according to the third embodiment. FIG. 8 is a cross-sectional view taken along the line BB in FIG. FIG. 9 is a plan view of the sheet before the medical sheath of FIG. 7 is placed thereon. FIG. 10 is a cross-sectional view of a modification of the BB cross section in FIG. Note that, regarding the medical device according to the third embodiment, a detailed explanation of the parts that overlap with the medical device according to the first embodiment and the medical device according to the second embodiment will be omitted.

As shown in FIGS. 7 and 8, the medical device 103 according to the third embodiment includes a base sheet 10, a medical sheath 20, and a medical device at least partially disposed in the inner cavity 20L of the medical sheath 20. The first fixing member 1 detachably fixes the sheath 20 to the base sheet 10. The first fixing member 1 preferably has a first fixing part 1C that extends in the first direction 1X and is fixed to the base sheet 10 at one end 1A in the first direction 1X.

The first fixing member 1 preferably has a second fixing portion 2C fixed to the base sheet 10 at the other end of the first fixing member 1 in the first direction 1X. As a result, the non-fixed part 1F between the first fixed part 1C and the second fixed part 2C of the first fixed member 1 can be placed in a floating state like a bridge, so that the non-fixed part 1F can be placed in a medical sheath. It can be inserted into or removed from the inner cavity 20L through the notch 20S at 20. Therefore, it is preferable that the first fixing member 1 does not have any other fixing part between the first fixing part 1C and the second fixing part 2C.

The length of the non-fixed portion 1F in the first direction 1X is preferably 1.01 times or more and 1.20 times or less, and 1.02 times or more and 1. More preferably, it is .10 times or less. This makes it possible to suppress the movement of the medical sheath 20 in the axial direction 20X while making it easier to avoid damage to both ends of the medical sheath 20.

As shown in FIG. 10, at least a portion of the first fixing member 1 may be sandwiched between the cuts 20S of the medical sheath 20. This makes it easier to prevent deformation such as one of the cut edges of the cut 20S of the medical sheath 20 going inward than the other cut edge when vertical pressure is applied to the medical sheath 20. be able to.

Although not shown, the base sheet 10 may have a notch extending in the first direction 1X in a portion where the first fixing member 1 is arranged. With this cut, when pressure is applied to the medical sheath 20, the pressure can be relieved or at least a part of the medical sheath 20 can be moved downward, so that the medical sheath 20 becomes difficult to deform. Thereby, a plurality of medical instruments 103 can be stacked to facilitate sterilization. For details of the cuts, refer to the description of the cuts of the medical device 101 according to the first embodiment.

Although not shown, it is preferable that the first fixing member 1 has a first widened portion that increases in width toward the first fixing portion 1C in a portion adjacent to the first fixing portion 1C. Further, it is preferable that the first fixing member 1 has a first constant width portion having a constant width in a portion adjacent to the first widened portion. Furthermore, it is preferable that the first fixing member 1 has a second widened part that increases in width toward the second fixing part 2C in a portion adjacent to the second fixing part 2C. For details of the first widened part, the first constant width part, and the second widened part, see the first widened part 1D, the first constant width part 1E, and the second widened part 2D of the medical device 102 according to the second embodiment. Please refer to .

Although not shown, each of the medical devices 101, 102, and 103 has a medical tubular body and a protective tube in which at least a portion of the medical tubular body is disposed, and the base sheet 10 has a pair of The cut edges of the pair of cuts each sandwich the wound protective tube, and at least the first fixing member 1 extends from one cut of the pair of cuts to the other cut. Preferably, the area is located outside the area. Since the medical tools 101, 102, and 103 have the medical sheath 20, the protective tube, and the medical tubular body, the medical sheath 20, the protective tube, and the medical tubular body can be sterilized together. . In addition, since the area from one notch to the other is easily deformed when attaching and detaching the protective tube, by placing the medical sheath 20 in an area outside of this area, it is possible to It is possible to easily prevent the medical sheath 20 from detaching at a timing when the medical sheath 20 is not in use. Conversely, when attaching and detaching the medical sheath 20, it is possible to easily prevent detachment of the protective tube at an unintended timing.

It is preferable that the pair of flaps formed by the pair of cuts each extend in a direction toward the outside of the base sheet 10. This makes it easier for each flap to hold the wound protective tube.

Preferably, the medical sheath 20 is located inside the rolled protective tube. Such an arrangement can reduce the pressure applied to the medical sheath 20 when medical tools are stacked.

The base sheet 10 may have other cuts. Further, the medical devices 101, 102, 103 may further include other members, and the other members may be fixed to the base sheet 10 by the cut edge of one or more other cuts. . Other members include syringes, mandrels, guide wires, needles, dilators, inserters, rippers, and the like.

The shape of the outer edge of the cross section in the thickness direction of the protection tube 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. A circular or oval shape is more preferred, and a circular shape is even more preferred. The shape of the outer edge of the inner lumen in the cross section in the thickness direction of the protection tube is preferably circular, oval, polygonal, rounded polygonal, or a combination thereof, and circular, oval, or rounded polygonal is preferable. More preferably, a circular or oval shape is even more preferred, and a circular shape is even more preferred. The protective tube may contain polyolefin resin such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc., polyvinyl chloride resin, polystyrene resin, polyamide resin, polyimide resin, or a mixture thereof. good.

The outer diameter of the protective tube in the thickness direction is preferably larger than the outer diameter of the medical sheath 20. This makes it difficult for the medical sheath 20 to deform when a plurality of medical tools are stacked.

The medical tubular body is preferably a balloon catheter, a microcatheter, or a penetration catheter, and more preferably a balloon catheter. Preferably, the medical tubular body has a handle portion at its proximal end. The protection tube may be of any type as long as at least a portion of the medical tubular body can be placed therein. Preferably, the shape of the protective tube is fixed by a plurality of clips in a wound state.

1 First fixing member 1 End portion 2C Second fixed portion 2D Second widened portion 2E Second constant width portion 2F Non-fixed portion 10 Base sheet 20 Medical sheath 20L Lumen 20O Opening 20X Axial direction 20S Notch 101, 102, 103 Medical device

Claims (16)

a base sheet,
a medical sheath;
A medical device comprising: a first fixing member, at least a portion of which is disposed in the inner cavity of the medical sheath, and detachably fixes the medical sheath to the base sheet. The medical device according to claim 1, wherein the first fixing member has a first fixing part that extends in the first direction and is fixed to the base sheet at one end in the first direction. Further, the second fixing member extends in a second direction, and has at least a portion disposed in the inner cavity of the medical sheath to removably fix the medical sheath to the base sheet, and the second fixing member The member has a second fixing part fixed to the base sheet at one end in the second direction,
The medical device according to claim 2, wherein the other end of the second fixing member in the second direction faces the other end of the first fixing member in the first direction. The first fixing member has a first widened part that increases in width toward the first fixing part in a portion adjacent to the first fixing part,
4. The medical device according to claim 3, wherein the second fixing member has a second widened part that increases in width toward the second fixing part in a portion adjacent to the second fixing part. The first fixing member has a first constant width portion having a constant width in a portion adjacent to the first widened portion,
The medical device according to claim 4, wherein the second fixing member has a second constant width portion having a constant width in a portion adjacent to the second widened portion. The first fixing member and the second fixing member each have a non-fixed portion that is not fixed to the base sheet, and each of the non-fixed portions has at least a portion in the inner cavity of the medical sheath. The medical device according to claim 3 or 4, wherein the medical device is arranged. The medical device according to claim 6, wherein the length of the non-fixed portion of the first fixing member in the first direction is longer than the length of the non-fixed portion of the second fixing member in the second direction. The medical device according to claim 6, wherein the non-fixing portion of the first fixing member and the non-fixing portion of the second fixing member each have a flap shape. The medical device according to claim 3 or 4, wherein the first fixing member and the second fixing member are not in contact with each other. The medical device according to claim 2, wherein the first fixing member has a second fixing part fixed to the base sheet at the other end of the first fixing member in the first direction. The medical device according to claim 1 or 2, wherein the width of the portion of the first fixing member disposed in the inner cavity of the medical sheath is smaller than the diameter of the inner cavity of the medical sheath. 5. The medical device according to claim 3, wherein the width of the portion of the second fixing member disposed in the inner cavity of the medical sheath is smaller than the diameter of the inner cavity of the medical sheath. The medical device according to claim 1 or 2, wherein the first fixing member is sheet-shaped. The medical device according to claim 3 or 4, wherein the second fixing member is sheet-shaped. The medical device according to claim 1 or 2, wherein the medical sheath has a notch extending in the axial direction. The medical device according to claim 15, wherein at least a portion of the first fixing member is sandwiched between the notches of the medical sheath.

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