JP2023172184A - 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 sheet with a first cut and a medical sheath. A cutting edge of the first cut is at least partially disposed in the lumen of the medical sheath.SELECTED DRAWING: Figure 7

Description

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 sheet having a first notch and a medical sheath,
The medical device, wherein at least a portion of the cut edge of the first cut is disposed in the lumen of the medical sheath.

As described above, at least a part of the cut edge of the first cut of the sheet is arranged in the lumen of the medical sheath, so that the lumen side of the medical sheath is supported by a part of the sheet. Therefore, the medical sheath becomes difficult to deform.

The medical device according to the embodiment is preferably one of the following [2] to [15].
[2] The first cut has a portion A1 extending in the first direction,
The medical device according to [1], wherein the sheet has a second cut, and the second cut has a portion B1 extending in the second direction and facing the portion A1 in the width direction. .
[3] The medical device according to [2], wherein the portion A1 and the portion B1 are each linear.
[4] The medical device according to [2] or [3], wherein the first direction and the second direction are parallel.
[5] The first cut has a portion A2 adjacent to one end of the portion A1 in the first direction,
The second cut has a portion B2 adjacent to one end of the portion B1 in the second direction, and one end of the portion B1 is closer to the portion B2 than the other end of the portion A1 in the first direction. Close to one end of part A1,
The medical device according to any one of [2] to [4], wherein the portion A2 and the portion B2 extend in directions away from each other from one end of the portion A1 and one end of the portion B1.
[6] The first cut has a portion A3 adjacent to the other end of the portion A1 in the first direction,
The second cut has a portion B3 adjacent to the other end of the portion B1 in the second direction,
The medical device according to [5], wherein the portion A3 and the portion B3 extend in a direction away from each other from the other end of the portion A1 and the other end of the portion B1.
[7] The portion A1 is longer than the portion A2 and longer than the portion A3,
The medical device according to [6], wherein the portion B1 is longer than the portion B2 and longer than the portion B3.
[8] In the portion of the sheet disposed in the inner cavity of the medical sheath, the distance from the portion A1 to the portion B1 in the direction perpendicular to the axial direction of the medical sheath is The medical device according to any one of [2] to [7], which is shorter than the diameter of the inner lumen of the medical device.
[9] The medical device according to any one of [1] to [8], wherein the medical sheath has a notch extending in the axial direction.
[10] The sheet has a third cut that passes through one point in the portion A1 excluding both ends of the portion A1 and one point in the portion B1 excluding both ends of the portion B1.[ 2] to [9].
[11] The third cut is on a side closer to the one end of the one end and the other end of the portion A1 in the first direction, and on a side closer to the one end of the portion B1 in the second direction. The medical device according to [10], which is located on the side closer to one end among the ends.
[12] The medical device according to [10] or [11], wherein the width of the third cut is larger than the width of the first cut.
[13] The portion A1 is shorter than the portion A2 and shorter than the portion A3,
The medical device according to [6], wherein the portion B1 is shorter than the portion B2 and shorter than the portion B3.
[14] In a portion of the sheet disposed in the lumen of the medical sheath,
The distance from the portion A2 to the portion A3 in the direction perpendicular to the axial direction of the medical sheath is shorter than the diameter of the inner cavity of the medical sheath, and The medical device according to [13], wherein the distance from the portion B2 to the portion B3 in the direction is shorter than the diameter of the lumen of the medical sheath.
[15] Furthermore, it has a medical tubular body and a protection tube in which at least a portion of the medical tubular body is disposed,
The sheet has a pair of notches, and the cut edges of the pair of notches each sandwich the wound protective tube,
The method according to any one of [2] to [14], wherein the first cut and the second cut are located outside a region from one cut to the other of the pair of cuts. Medical equipment.

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 an example of a medical sheath. FIG. 4 is a plan view of the medical device according to the second embodiment. FIG. 5 is a cross-sectional view taken along the line BB in FIG. 4. FIG. 6 is a plan view of the sheet before the medical sheath of FIG. 4 is placed thereon. FIG. 7 is a plan view of the medical device according to the third embodiment. FIG. 8 is a sectional view taken along the line CC 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 plan view of a modification of the sheet shown in FIG. 9. FIG. 11 is a plan view of the medical device according to the fourth embodiment. FIG. 12 is a plan view of the medical device according to the fifth embodiment.

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 sheet having a first cut and a medical sheath, and at least a part of the cut edge of the first cut is disposed in the inner cavity of the medical sheath. has been done.

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, since the cut edge of the first cut of the sheet can support the lumen side of the medical sheath, deformation of the medical sheath can be reduced. can.

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 the medical device according to the first embodiment, and FIG. 2 is a cross-sectional view taken along the line AA in FIG. FIG. 3 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 sheet 10 having a first cut 1S and a medical sheath 20, and has a cut edge of the first cut 1S. At least a portion of 1Ea is disposed in the lumen 20L of the medical sheath 20. The lumen 20L side of the medical sheath 20 can be supported by the cut edge 1Ea of the first cut 1S of the sheet 10 and the area near the cut edge 1Ea. As a result, deformation of the medical sheath 20 due to heat sterilization can be reduced.

As shown in FIG. 1, the first cut 1S preferably has a portion A1 (SA1) extending in the first direction 1X. It is preferable that the portion A1 (SA1) is linear. This makes it easier for the cut edge 1Ea of the first cut 1S of the sheet 10 and the region near the cut edge 1Ea to support the lumen 20L side of the medical sheath 20 extending linearly. Moreover, the first cut 1S may consist of a portion A1 (SA1) extending in the first direction 1X.

The portion A1 (SA1) of the first cut 1S may be a non-linear cut such as an arc shape or a wave shape. In the case of a non-linear cut, the portion A1 (SA1) may be located within a region from a virtual line segment connecting both ends of the portion A1 (SA1) to a position a predetermined distance away in a direction perpendicular to the virtual line segment. preferable. This corresponds to, for example, when the portion A1 (SA1) has a wave shape extending in the first direction 1X, the amplitude of the wave is equal to or less than a predetermined distance. The predetermined distance is preferably 1/2 or less, more preferably 1/4 or less, and even more preferably 1/10 or less of the diameter of the inner lumen 20L of the medical sheath 20. As a result, the non-linear portion A1 (SA1) becomes nearly linear. On the other hand, the predetermined distance may be 1/100 or more, 1/50 or more, or 1/20 or more of the diameter of the inner cavity 20L of the medical sheath 20. The diameter of the lumen 20L of the medical sheath 20 is a virtual diameter 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 among the line segments. In addition, when the medical sheath 20 has the cut 20S, the outer edge of the cut 20S is not included in the outer edge of the lumen 20L.

As shown in FIG. 2, among the incision edge 1Ea on one side and the incision edge 1Eb on the other side of the first incision 1S, the incision edge 1Ea on one side is arranged in the lumen 20L of the medical sheath 20, and the other incision edge 1Ea is arranged in the inner cavity 20L of the medical sheath 20. It is preferable that the side incision edge 1Eb is disposed outside the medical sheath 20. Thereby, the sheet 10 can support the medical sheath 20 from the inside and outside of the medical sheath 20, making it difficult for the medical sheath 20 to move.

It is preferable that the cut edge 1Ea on one side of the first cut 1S is in contact with the inner surface of the medical sheath 20. This makes it difficult for the medical sheath 20 to deform. Furthermore, it is preferable that the other incision edge 1Eb of the first incision 1S is in contact with the outer surface of the medical sheath 20. This makes it difficult for the medical sheath 20 to move.

As shown in FIG. 1, the first cut 1S includes a portion A1 (SA1) extending in the first direction 1X, and a portion A2 (SA2) adjacent to one end SA1a of the portion A1 (SA1) in the first direction 1X. and a portion A3 (SA3) adjacent to the other end SA1b. Further, the portion A2 (SA2) and the portion A3 (SA3) move away from each other as they move away from one end SA1a and the other end SA1b, respectively, in a direction perpendicular to the imaginary line segment connecting the one end SA1a and the other end SA1b. It is preferable that it extends like this. Since the tapered flap 10F can be formed by the portion A1 (SA1), the portion A2 (SA2), and the portion A3 (SA3), the medical sheath 20 can be easily attached and detached.

It is preferable that the portion A2 (SA2) and the portion B2 (SB2) are each linear. The portion A2 (SA2) and the portion B2 (SB2) may each be non-linear cuts. For details of the non-linear cut, refer to the description of the non-linear cut in the portion A1 (SA1).

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

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

The 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.

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 to hold the medical sheath 20 by a portion of the sheet 10. 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 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. is even more preferable. Thereby, while supporting the lumen 20L side of the medical sheath 20, it is possible to easily supply sterilizing gas such as heated sterilization gas to the lumen 20L. The area of the region surrounded by the outer edge of the 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 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 rectangle. It is even more preferable that there be. When the shape of the sheet 10 is a polygon or a rounded polygon, the lengths of the imaginary line segments connecting the centroid of the sheet 10 and each vertex may be the same, but There may be at least one short virtual line segment.

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.

It is preferable that the medical sheath 20 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 sheet 10. In addition, for example, the medical sheath 20 can be removed from the sheet 10 by pinching and lifting it with the thumb and forefinger, and the medical sheath does not get caught on the holding part of the holding mount as in the conventional example, which improves usability. preferred.

As shown in FIG. 3, 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 containing the sheet 10 and the medical sheath 20. This makes it easier to maintain the sterile state of the medical sheath 20 and the like after sterilization. Examples of 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. 4, 5, and 6. FIG. 4 is a plan view of the medical device according to the second embodiment. FIG. 5 is a cross-sectional view taken along the line BB in FIG. 4. FIG. 6 is a plan view of the sheet before the medical sheath of FIG. 4 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. 4 and 5, the medical device 102 according to the second embodiment includes a sheet 10 having a first cut 1S and a medical sheath 20, and has a cut edge of the first cut 1S. At least a portion of 1Ea is disposed in the lumen 20L of the medical sheath 20.

As shown in FIGS. 4 and 6, the first cut 1S has a portion A1 (SA1) extending in the first direction 1X, and the sheet 10 has a second cut 2S. 2S preferably has a portion B1 (SB1) extending in the second direction 2X and facing portion A1 (SA1) in the width direction. As a result, a bridge portion 13 of the sheet 10 is formed between the portion A1 (SA1) and the portion B1 (SB1), and the bridge portion 13 can support the lumen 20L side of the medical sheath 20. Furthermore, as shown in FIG. 5, since the sheet 10 is formed with a hole 14 that follows the shape of the bridge section 13, even if pressure is applied to the medical sheath 20 from above, at least a portion of the medical sheath 20 Since it can be moved downward, the medical sheath 20 is less likely to deform. Thereby, a plurality of medical instruments 102 can be stacked to facilitate sterilization.

As shown in FIG. 5, among the cut edges 1Ea and 1Eb of the first cut 1S and the cut edges 2Ea and 2Eb of the second cut 2S, the cut edges 1Ea and 2Ea on the bridge portion 13 side are inside the medical sheath 20. It is preferable that the cut edges 1Eb and 2Eb on the side facing the bridge portion 13 be placed outside the medical sheath 20. Thereby, the sheet 10 can support the medical sheath 20 from the inside and outside of the medical sheath 20, making it difficult for the medical sheath 20 to move.

It is preferable that the cut edge 1Ea, the cut edge 2Ea, or the cut edge 1Ea and the cut edge 2Ea on the bridge portion 13 side are in contact with the inner surface of the medical sheath 20. This makes the medical sheath 20 difficult to deform. Therefore, it is more preferable that the cut edge 1Ea and the cut edge 2Ea are in contact with the inner surface of the medical sheath 20.

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

The width of the portion A1 (SA1) in a state where the medical sheath 20 is not placed is preferably smaller than the wall thickness of the medical sheath 20. Thereby, the medical sheath 20 can be easily supported by the cut edge 1Ea on one side and the cut edge 1Eb on the other side of the first cut 1S.

The width of the portion B1 (SB1) in a state where the medical sheath 20 is not placed is preferably smaller than the wall thickness of the medical sheath 20. Thereby, the medical sheath 20 can be easily supported by the cut edge 2Ea on one side and the cut edge 2Eb on the other side of the second cut 2S.

As shown in FIG. 6, the first direction 1X and the second direction 2X are preferably parallel. As a result, the lumen 20L side of the medical sheath 20 is supported by the bridge portion 13 between the portion A1 (SA1) extending in the first direction 1X and the portion B1 (SB1) extending in the second direction 2X. It becomes easier. 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.

It is preferable that the portion A1 (SA1) and the portion B1 (SB1) are each linear. This makes it easier for the bridge portion 13 to support the inner cavity 20L side of the medical sheath 20. The portion A1 (SA1) and the portion B1 (SB1) may each be non-linear cuts. For details of the non-linear cuts, refer to the description of the medical device 101 according to the first embodiment.

The length of the portion A1 (SA1) and the length of the portion B1 (SB1) are preferably 1.00 times or more and 1.20 times or less the length of the medical sheath 20 in the axial direction 20X, respectively, and 1. More preferably, it is .01 times or more and 1.10 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 FIGS. 4 and 6, the first cut 1S has a portion A2 (SA2) adjacent to one end SA1a of the portion A1 (SA1) in the first direction 1X, and the second cut 2S has a portion A2 (SA2) adjacent to one end SA1a of the portion A1 (SA1) in the first direction 1X. It has a portion B2 (SB2) adjacent to one end SB1a of portion B1 (SB1) in two directions 2X, and one end SB1a of portion B1 (SB1) is adjacent to the other end of portion A1 (SA1) in first direction 1X. One end SA1a of part A1 (SA1) is closer to one end SA1a of part A1 (SA1) than SA1b, and part A2 (SA2) and part B2 (SB2) are separated from one end SA1a of part A1 (SA1) and one end SB1a of part B1 (SB1). Preferably, it extends in the direction. The force applied to the medical sheath 20 near the one end SA1a and the one end SB1a can be alleviated by the portion A2 (SA2) and the portion B2 (SB2) extending in the direction away from each other. , one end of the medical sheath 20 is less likely to be damaged. This also makes it difficult for the medical sheath 20 to move in the axial direction 20X.

The angle of inclination of portion A2 (SA2) with respect to portion A1 (SA1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. This makes it difficult for one end of the medical sheath 20 to be damaged and makes it difficult 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 allows the medical sheath 20 to be easily attached and detached. The inclination angle is the inclination angle of the imaginary line segment connecting both ends of portion A2 (SA2) with respect to the imaginary line segment connecting both ends of portion A1 (SA1).

The inclination angle of portion B2 (SB2) with respect to portion B1 (SB1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. This makes it difficult for one end of the medical sheath 20 to be damaged and makes it difficult 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 allows the medical sheath 20 to be easily attached and detached. The inclination angle is the inclination angle of the imaginary line segment connecting both ends of portion B2 (SB2) with respect to the imaginary line segment connecting both ends of portion B1 (SB1).

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

The first cut 1S has a portion A3 (SA3) adjacent to the other end SA1b of the portion A1 (SA1) in the first direction 1X, and the second cut 2S has a portion B1 (SB1) in the second direction 2X. ) has a portion B3 (SB3) adjacent to the other end SB1b, and the portion A3 (SA3) and the portion B3 (SB3) are connected to the other end SA1b of the portion A1 (SA1) and the other end of the portion B1 (SB1). It is preferable that they extend in a direction away from each other from part SB1b. The portion A3 (SA3) and the portion B3 (SB3) extending in the direction away from each other can alleviate the force applied to the medical sheath 20 near the other end SA1b and the other end SB1b. Therefore, the other end of the medical sheath 20 is less likely to be damaged. This also makes it difficult for the medical sheath 20 to move in the axial direction 20X.

The angle of inclination of portion A3 (SA3) with respect to portion A1 (SA1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. This makes it difficult for the other end of the medical sheath 20 to be damaged and makes it difficult 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 allows the medical sheath 20 to be easily attached and detached. The inclination angle is the inclination angle of the imaginary line segment connecting both ends of portion A3 (SA3) with respect to the imaginary line segment connecting both ends of portion A1 (SA1).

The inclination angle of portion B3 (SB3) with respect to portion B1 (SB1) is preferably 1 degree or more, more preferably 3 degrees or more, and even more preferably 5 degrees or more. This makes it difficult for the other end of the medical sheath 20 to be damaged and makes it difficult 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 allows the medical sheath 20 to be easily attached and detached. The inclination angle is the inclination angle of the imaginary line segment connecting both ends of portion B3 (SB3) with respect to the imaginary line segment connecting both ends of portion B1 (SB1).

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

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

As shown in FIG. 4, in the portion of the sheet 10 disposed in the inner cavity 20L of the medical sheath 20, from portion A1 (SA1) to portion B1 (SB1) in the direction 20Y perpendicular to the axial direction 20X of the medical sheath 20. It is preferable that the distance thereto is shorter than the diameter of the lumen 20L of the medical sheath 20. Thereby, the bridge portion 13 of the sheet 10 between the portion A1 (SA1) and the portion B1 (SB1) can be easily placed in the lumen 20L of the medical sheath 20. Furthermore, this makes it easier to reduce the opening of the cut 20S during heat sterilization. Furthermore, as shown in FIG. 5, this makes it difficult for the medical sheath 20 to pass through the hole 14 formed along the shape of the bridge section 13, making it easier to grasp the medical sheath 20 during removal. be able to. The distance 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. Thereby, the lumen 20L side of the medical sheath 20 can be easily supported by the bridge portion 13.

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 sectional view taken along the line CC 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 plan view of a modification of the sheet shown in FIG. 9. Note that, regarding the medical device according to the third embodiment, a detailed explanation of the parts that overlap with the medical devices according to the first embodiment and the second embodiment will be omitted.

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

As shown in FIGS. 7 and 9, the sheet 10 has one point in the portion A1 (SA1) excluding both ends of the portion A1 (SA1), and one point in the portion B1 (SB1) excluding both ends of the portion B1 (SB1). It is preferable to have a third cut 3S passing through the point. The first flap 11 and the second flap 12 can be formed by the portion A1 (SA1), the portion B1 (SB1), and the third cut 3S. Since the first flap 11 and the second flap 12 can be moved independently, they can be easily inserted into the inner cavity 20L of the medical sheath 20. Furthermore, even if the medical sheath 20 does not have the cut 20S extending in the axial direction 20X, the first flap 11 and the second flap 12 can be inserted into the medical sheath 20 as shown in FIG. It can be inserted into the cavity 20L. Furthermore, when the first flap 11 and the second flap 12 are lifted, a hole 14 is formed between the portion A1 (SA1) and the portion B1 (SB1), so even if pressure is applied from above, the medical sheath Since at least a portion of 20 can move downward, the medical sheath 20 is less likely to deform.

It is preferable that the third cut 3S is linear. This makes it easier to manufacture the sheet 10, so costs can be reduced.

As shown in FIG. 9, the third cut 3S is located on the side closer to the one end SA1a of the one end SA1a and the other end SA1b of the portion A1 (SA1) in the first direction 1X, and on the side closer to the one end SA1a in the second direction 2X. It is preferable to locate one end SB1a and the other end SB1b of the portion B1 (SB1) on the side closer to the one end SB1a. Thereby, the first flap 11 having a long length in the extending direction and the second flap 12 having a short length in the extending direction can be formed. For example, by inserting the first flap 11 and the second flap 12 into the inner cavity 20L of the medical sheath 20 and heat sterilizing them, first removing the second flap 12 having a shorter length in the extending direction. , the first flap 11 having a long length in the extending direction can be smoothly removed. Further, in the case of the medical sheath 20 shown in FIG. 3, the second flap 12 having a short length in the extending direction is inserted into the opening 20O, and the second flap 12 having a short length in the extending direction is inserted into the opening on the opposite side to the opening 20O. Preferably, a long first flap 11 is inserted. Thereby, the medical sheath 20 can be easily removed from the sheet 10. Further, when removing the medical sheath 20 from the sheet 10, the first flap 11 and the second flap 12 inserted from the opening 20O and the opening on the opposite side, not from the notch 20S of the medical sheath 20, are removed. Since it can be removed, the medical sheath 20 can be removed from the sheet 10 more easily.

The third notch 3S is preferably separated from the other end SA1b by a distance of 0.51 times or more and 0.80 times or less of the straight-line distance from the other end SA1b to the one end SA1a, and is preferably 0. More preferably, the distance is 55 times or more and 0.70 times or less. Further, the third notch 3S is preferably spaced from the other end SB1b by a distance of at least 0.51 times and at most 0.80 times the linear distance from the other end SB1b to the one end SB1a, More preferably, the distance is 0.55 times or more and 0.70 times or less. Thereby, it is possible to both fix the medical sheath 20 by the first flap 11 and the second flap 12 and facilitate attachment and detachment.

As shown in FIG. 10, the width of the third cut 3S is preferably larger than the width of the first cut 1S. This makes it difficult for the tips of the first flap 11 and the second flap 12 to come into contact with each other when the sheet 10 is curved as a whole. This makes it easier to avoid pressure on people. Therefore, the width of the third cut 3S is preferably 1.1 times or more, more preferably 2 times or more, even more preferably 5 times or more, and even more preferably 1.1 times or more the width of the first cut 1S. It is even more preferable that it is twice or more. On the other hand, the width of the third cut 3S is preferably 500 times or less, more preferably 200 times or less, even more preferably 100 times or less, and 50 times the width of the first cut 1S. It is even more preferable that it is the following. This makes it easier to support the lumen 20L side of the medical sheath 20 as a whole by the first flap 11 and the second flap 12.

The width of the second cut 2S is preferably 0.9 times or more and 1.1 times or less the width of the first cut 1S. This makes it easier to manufacture the sheet 10, so costs can be reduced.

Below, a medical device according to a fourth embodiment will be described with reference to FIG. 11. FIG. 11 is a plan view of the medical device according to the fourth embodiment. Note that, regarding the medical device according to the fourth embodiment, a detailed explanation of the parts that overlap with the medical devices according to the first embodiment, the second embodiment, and the third embodiment will be omitted.

As shown in FIG. 11, a medical device 104 according to the fourth embodiment includes a sheet 10 having a first cut 1S and a medical sheath 20, and includes at least a cut edge 1Ea of the first cut 1S. A portion is disposed in the lumen 20L of the medical sheath 20. Further, in the medical device 104, the first cut 1S has a portion A1 (SA1) extending in the first direction 1X, the sheet 10 has a second cut 2S, and the second cut 2S has a portion A1 (SA1) extending in the first direction 1X. It is preferable to have a portion B1 (SB1) extending in the second direction 2X and facing the portion A1 (SA1) in the width direction.

As shown in FIG. 11, the first cut 1S has a portion A2 (SA2) adjacent to one end SA1a of the portion A1 (SA1) in the first direction 1X, and the second cut 2S has a portion A2 (SA2) adjacent to one end SA1a of the portion A1 (SA1) in the first direction 1X. has a portion B2 (SB2) adjacent to one end SB1a of portion B1 (SB1), and one end SB1a of portion B1 (SB1) is larger than the other end SA1b of portion A1 (SA1) in the first direction 1X. Near one end SA1a of part A1 (SA1), part A2 (SA2) and part B2 (SB2) move away from one end SA1a of part A1 (SA1) and one end SB1a of part B1 (SB1) in a direction away from each other. It is preferable that it extends. Further, the first cut 1S has a portion A3 (SA3) adjacent to the other end SA1b of the portion A1 (SA1) in the first direction 1X, and the second cut 2S has a portion B1 in the second direction 2X. (SB1) has a portion B3 (SB3) adjacent to the other end SB1b, and the portion A3 (SA3) and the portion B3 (SB3) are connected to the other end SA1b of the portion A1 (SA1) and the portion B1 (SB1). It is preferable that they extend in a direction away from each other from the other end SB1b.

As shown in FIG. 11, portion A1 (SA1) is shorter than portion A2 (SA2) and shorter than portion A3 (SA3), portion B1 (SB1) is shorter than portion B2 (SB2), and portion B3 ( It is preferably shorter than SB3). With this configuration, the first flap 11 is formed by the portion A1 (SA1), the portion A2 (SA2), and the portion A3 (SA3), and the first flap 11 is formed by the portion B1 (SB1), the portion B2 (SB2), and the portion B3 (SB3). The second flap 12 can be formed by this. Since the first flap 11 and the second flap 12 can be moved independently, a part of the sheet 10 can be easily placed in the inner cavity 20L of the medical sheath 20. Further, even if the medical sheath 20 does not have the cut 20S extending in the axial direction 20X, a part of the sheet 10 can be placed in the inner cavity 20L of the medical sheath 20.

In the portion of the sheet 10 disposed in the lumen 20L of the medical sheath 20, the distance from portion A2 (SA2) to portion A3 (SA3) in the direction 20Y perpendicular to the axial direction 20X of the medical sheath 20 is: The distance from part B2 (SB2) to part B3 (SB3) in the direction 20Y perpendicular to the axial direction 20X of the medical sheath 20 is shorter than the diameter of the inner lumen 20L of the medical sheath 20. It is preferable that the diameter is shorter than the diameter of the inner lumen 20L of 20. Thereby, the first flap 11 and the second flap 12 can be easily arranged in the inner cavity 20L of the medical sheath 20. The distance 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. Thereby, the inner cavity 20L side of the medical sheath 20 can be easily supported by the first flap 11 and the second flap 12.

It is preferable that portion A2 (SA2), portion A3 (SA3), portion B2 (SB2), and portion B3 (SB3) are each linear. Thereby, the first flap 11 and the second flap 12 can be easily placed in the inner cavity 20L of the medical sheath 20. Note that each of the portion A2 (SA2), the portion A3 (SA3), the portion B2 (SB2), and the portion B3 (SB3) may be a non-linear cut. For details of the non-linear cuts, refer to the description of the medical device 101 according to the first embodiment.

The length of the portion A2 (SA2) and the length of the portion A3 (SA3) are preferably 0.30 times or more and 0.80 times or less the length of the medical sheath 20 in the axial direction 20X, respectively. The length is more preferably 0.50 times or more and 0.70 times or less, and even more preferably 0.55 times or more and 0.60 times or less. On the other hand, the length of portion B2 (SB2) and the length of portion B3 (SB3) shall be 0.20 times or more and 0.70 times or less the length of the medical sheath 20 in the axial direction 20X, respectively. The length is preferably 0.30 times or more and 0.50 times or less, and even more preferably 0.40 times or more and 0.45 times or less. Further, it is preferable that the portion A2 (SA2) is longer than the portion B2 (SB2), and that the portion A3 (SA3) is longer than the portion B3 (SB3). Thereby, the length of the first flap 11 in the extending direction can be made longer than the length of the second flap 12 in the extending direction.

The inclination angles of portion A2 (SA2) and portion A3 (SA3) with respect to portion A1 (SA1) are preferably 70 degrees or more and 95 degrees or less, and more preferably 80 degrees or more and 93 degrees or less, respectively. , more preferably 85 degrees or more and 91 degrees or less, and most preferably 90 degrees. Thereby, the medical sheath 20 can be easily supported by the first flap 11 from the inner cavity 20L side. Note that the inclination angle of part A2 (SA2) with respect to part A1 (SA1) is the inclination angle of the imaginary line segment connecting both ends of part A2 (SA2) with respect to the imaginary line segment connecting both ends of part A1 (SA1). The inclination angle of the portion A3 (SA3) with respect to the portion A1 (SA1) is the inclination angle of the imaginary line segment connecting both ends of A3 (SA3) with respect to the imaginary line segment connecting both ends of the portion A1 (SA1). Further, for example, when the inclination angles of the portion A2 (SA2) and the portion A3 (SA3) with respect to the portion A1 (SA1) are respectively 70 degrees or more and less than 90 degrees, the shape of the first flap 11 is a tapered shape. becomes.

The inclination angles of portion B2 (SB2) and portion B3 (SB3) with respect to portion B1 (SB1) are preferably 70 degrees or more and 95 degrees or less, and more preferably 80 degrees or more and 93 degrees or less, respectively. , more preferably 85 degrees or more and 91 degrees or less, and most preferably 90 degrees. Thereby, the medical sheath 20 can be easily supported by the second flap 12 from the inner cavity 20L side. Note that the inclination angle of portion B2 (SB2) with respect to portion B1 (SB1) is the inclination angle of a virtual line segment connecting both ends of portion B2 (SB2) with respect to a virtual line segment connecting both ends of portion B1 (SB1). The inclination angle of portion B3 (SB3) with respect to portion B1 (SB1) is the inclination angle of a virtual line segment connecting both ends of portion B3 (SB3) with respect to a virtual line segment connecting both ends of portion B1 (SB1). Further, for example, when the inclination angles of the portion B2 (SB2) and the portion B3 (SB3) with respect to the portion B1 (SB1) are respectively 70 degrees or more and less than 90 degrees, the shape of the second flap 12 is a tapered shape. becomes.

Below, a medical device according to a fifth embodiment will be described with reference to FIG. 12. FIG. 12 is a plan view of the medical device according to the fifth embodiment. Note that regarding the medical device according to the fifth embodiment, the parts that overlap with the medical devices according to the first embodiment, the second embodiment, the third embodiment, and the fourth embodiment are Detailed explanation will be omitted.

As shown in FIG. 12, a medical device 105 according to the fifth embodiment includes a sheet 10 having a first cut 1S and a medical sheath 20, and includes at least a cut edge 1Ea of the first cut 1S. A portion is disposed in the lumen 20L of the medical sheath 20.

As shown in FIG. 12, the medical device 105 further includes a medical tubular body 40 and a protective tube 30 in which at least a portion of the medical tubular body 40 is disposed, and the sheet 10 has a pair of notches 4S. The cut edges 4E of the pair of cuts 4S each sandwich the wound protective tube 30, and the first cut 1S and the second cut 2S are formed by one of the pair of cuts 4S. It is preferable to locate it outside the region 4R from the notch 4S1 to the other notch 4S2. Since the region 4R is a region that is easily deformed when the protective tube 30 is attached or removed, by arranging the medical sheath 20 outside the region 4R, the medical sheath 20 can be easily deformed at an unintended timing. Desorption can be easily prevented. Conversely, when attaching and detaching the medical sheath 20, it is possible to easily prevent the protective tube 30 from detaching at an unintended timing.

It is preferable that the pair of flaps formed by the pair of cuts 4S each extend in a direction toward the outside of the sheet 10. This makes it easier for each flap to hold the wound protection tube 30.

Preferably, the medical sheath 20 is located inside the rolled protective tube 30. Such an arrangement can reduce the pressure applied to the medical sheath 20 when the medical tools 105 are stacked.

As shown in FIG. 12, the medical device 105 includes the medical sheath 20, the protective tube 30, and the medical tubular body 40, so that the medical sheath 20, the protective tube 30, and the medical tubular body 40 are assembled together. Can be sterilized. Note that the sheet 10 may have other cuts. Additionally, the medical device 105 may further include other members, and the other members may be secured to the sheet 10 by the cut edges of one or more other cuts. Other members include syringes, mandrels, guide wires, needles, dilators, rewrappers, torquers, stopcocks, adapters, and the like.

The shape of the outer edge of the cross section of the protection tube 30 in the thickness direction is preferably a circle, an ellipse, a polygon, a rounded polygon, or a combination thereof, and 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 cavity in the cross section in the thickness direction of the protective tube 30 is preferably circular, elliptical, polygonal, rounded polygonal, or a combination thereof, such as circular, elliptical, or rounded polygonal. is more preferable, circular or elliptical is even more preferable, and circular is even more preferable. The protective tube 30 contains a 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 too.

The outer diameter of the protective tube 30 in the thickness direction is preferably larger than the outer diameter of the medical sheath 20. This makes it difficult for the medical sheath 20 to deform when a plurality of medical tools 105 are stacked.

The medical tubular body 40 is preferably a balloon catheter, a microcatheter, or a penetration catheter, and more preferably a balloon catheter. Preferably, the medical tubular body 40 has a handle portion at its proximal end. The protective tube 30 only needs to be able to accommodate at least a portion of the medical tubular body 40 therein. It is preferable that the shape of the protective tube 30 is fixed in a wound state by a plurality of clips. Note that the medical device 105 does not need to have the protective tube 30. In that case, the medical tubular body 40 may be held between the cut edges 4E of the pair of cuts 4S.

1Ea, 1Eb, 2Ea, 2Eb Cut edge 1S First cut SA1 Part A1
SA1a One end SA1b Other end SA2 Part A2
SA3 Part A3
1X First direction 2S Second cut SB1 Part B1
SB1a One end SB1b Other end SB2 Part B2
SB3 Part B3
2X Second direction 3S Third cut 4S Pair of cuts 4S1 One cut 4S2 Other cut 4R Region 4E Cut edge 10 Sheet 10F Flap 11 First flap 12 Second flap 13 Bridge 14 Hole 20 Medical sheath 20L Lumen 20X Axial direction 20S Cut 20Y Vertical direction 20O Opening 30 Protection tube 40 Medical tubular body 101, 102, 103, 104, 105 Medical tool

Claims (15)

comprising a sheet having a first notch and a medical sheath;
The medical device, wherein at least a portion of the cut edge of the first cut is disposed in the lumen of the medical sheath. The first cut has a portion A1 extending in a first direction,
The medical device according to claim 1, wherein the sheet has a second cut, and the second cut has a portion B1 extending in the second direction and facing the portion A1 in the width direction. . The medical device according to claim 2, wherein the portion A1 and the portion B1 are each linear. The medical device according to claim 2 or 3, wherein the first direction and the second direction are parallel. The first cut has a portion A2 adjacent to one end of the portion A1 in the first direction,
The second cut has a portion B2 adjacent to one end of the portion B1 in the second direction, and one end of the portion B1 is closer to the portion B2 than the other end of the portion A1 in the first direction. Close to one end of part A1,
The medical device according to claim 2 or 3, wherein the portion A2 and the portion B2 extend in directions away from each other from one end of the portion A1 and one end of the portion B1. The first cut has a portion A3 adjacent to the other end of the portion A1 in the first direction,
The second cut has a portion B3 adjacent to the other end of the portion B1 in the second direction,
The medical device according to claim 5, wherein the portion A3 and the portion B3 extend in a direction away from each other from the other end of the portion A1 and the other end of the portion B1. The portion A1 is longer than the portion A2 and longer than the portion A3,
The medical device according to claim 6, wherein the portion B1 is longer than the portion B2 and longer than the portion B3. In the portion of the sheet disposed in the inner cavity of the medical sheath, the distance from the portion A1 to the portion B1 in the direction perpendicular to the axial direction of the medical sheath is equal to The medical device according to claim 2 or 3, wherein the medical device has a diameter shorter than that of the medical device. The medical device according to claim 1 or 2, wherein the medical sheath has a notch extending in the axial direction. 2. The sheet has a third cut passing through one point in the portion A1 excluding both ends of the portion A1 and one point in the portion B1 excluding both ends of the portion B1. 3. Medical device according to item 3. The third cut is on the side closer to the one end of the one end and the other end of the portion A1 in the first direction, and on the side closer to the one end of the portion B1 in the second direction. The medical device according to claim 10, wherein the medical device is located on a side closer to one end. The medical device according to claim 10, wherein the width of the third cut is greater than the width of the first cut. The portion A1 is shorter than the portion A2 and shorter than the portion A3,
The medical device according to claim 6, wherein the portion B1 is shorter than the portion B2 and shorter than the portion B3. In a portion of the sheet disposed in the lumen of the medical sheath,
The distance from the portion A2 to the portion A3 in the direction perpendicular to the axial direction of the medical sheath is shorter than the diameter of the inner cavity of the medical sheath, and The medical device according to claim 13, wherein a distance from the portion B2 to the portion B3 in the direction is shorter than the diameter of the lumen of the medical sheath. Furthermore, it has a medical tubular body and a protection tube in which at least a portion of the medical tubular body is disposed,
The sheet has a pair of notches, and the cut edges of the pair of notches each sandwich the wound protective tube,
The medical device according to claim 2, wherein the first cut and the second cut are located outside a region from one cut to the other of the pair of cuts. .

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