JP6480217B2 - Balloon catheter storage device and balloon catheter assembly - Google Patents

Description

  The present invention relates to a balloon catheter storage device and a balloon catheter assembly including the balloon catheter storage device and a balloon catheter.

  As a device used for storing a balloon catheter, there is known a device including a stylet (core material) inserted into a guide wire lumen of a balloon catheter and a balloon cover that covers and protects the folded balloon. It has been.

  For example, in Patent Document 1 below, a storage device in which the tip of a stylet that is exposed from a guide wire lumen and the inner surface of the balloon cover are fixed with an adhesive, or an edge of the tip opening of the balloon cover are disclosed. A storage device is described in which a fitting member (fixing member) to be abutted is attached to the tip of the stylet, and the balloon cover and the stylet are fixed via the fitting member.

  In the medical field, a rimming cover may be used separately from the balloon cover. The re-grooming cover is a state where the balloon catheter is once taken out of the living body after performing the treatment using the balloon catheter, and then the outer diameter of the balloon is set to a predetermined size when the balloon catheter is inserted again into the living body. It is an instrument (sheath) used to reduce the diameter.

JP 2011-255086 A

  In the storage device for fixing the stylet and the balloon cover with an adhesive, it is difficult to separate the stylet and the balloon cover, so that it is difficult to reuse the stylet as the re-grooming cover. Therefore, when using a storage device that uses an adhesive to fix, a stylet dedicated to the rimming cover must be prepared separately at the medical site, etc., so there is room for improvement in terms of convenience. It can be said that there is.

  On the other hand, a storage device that uses a fitting member for fixing causes an increase in manufacturing cost and complication of manufacturing work due to an increase in the number of parts. Furthermore, since the fixing force between the stylet and the balloon cover greatly depends on the size and shape of the fitting member, the rimming cover is formed so that the diameter of the lumen is different from that of the balloon cover. In the case where it is shared with the above, there is a possibility that a sufficient fixing force cannot be secured. Therefore, it can be said that there is room for improvement in terms of convenience, as in the case of using an adhesive, for a storage device that uses a fitting member for fixing.

  The present invention has been made in view of the above problems, and can reduce the manufacturing cost and simplify the manufacturing operation, and can improve the convenience of the balloon catheter storage device, and An object of the present invention is to provide a balloon catheter assembly including a balloon catheter storage device and a balloon catheter.

  The present invention is a balloon catheter storage device used for storing a balloon catheter, comprising a lumen into which the balloon of the balloon catheter is inserted, and housing the balloon in a folded state, and the balloon A stylet that is detachably attached to the cover, and the stylet spreads outward with respect to a base portion inserted through the guide wire lumen of the balloon catheter and an axis along the longitudinal direction of the base portion. And a fixing part that acts on the balloon cover so as to detachably fix the stylet with respect to the balloon cover, and the base part and the fixing part are wire rods. It is comprised integrally by.

  According to the balloon catheter storage device, it is possible to easily attach and detach the stylet to and from the balloon cover by operating the fixing and releasing of the fixing between the fixing portion formed on the stylet and the balloon cover. Therefore, the stylet can be shared with the balloon cover and the rimming cover. In addition, since the fixed portion is formed by adding a shape that spreads outward to the axial line along the longitudinal direction of the base portion to the wire constituting the stylet, it is accompanied by adding a fixing function to the stylet An increase in the number of parts can be prevented. Therefore, it is possible to provide a balloon catheter storage device that can reduce the manufacturing cost and simplify the manufacturing operation and has improved convenience.

FIG. 1 is a view showing a balloon catheter storage device according to the first embodiment, in which (A) is a perspective view of a stylet provided in the balloon catheter storage device, and (B) is a stylet and a balloon cover. FIG. 4 is a view showing a rimming cover. 2A and 2B are diagrams showing a balloon catheter according to the embodiment, wherein FIG. 2A is a diagram showing a simplified overall configuration of the balloon catheter, and FIG. 2B is an enlarged cross-sectional view showing a distal end portion of the balloon catheter. . It is a figure which shows the balloon catheter assembly of the state accommodated in the packaging container. It is a figure for demonstrating the usage example of the balloon catheter storage instrument which concerns on 1st Embodiment, (A) is an expanded sectional view which shows a mode at the time of accommodating the balloon in a balloon cover, (B) is It is an expanded sectional view which shows the mode at the time of accommodating the balloon in the cover for rimming. 5A and 5B are diagrams showing each modification of the stylet according to the first embodiment. FIG. 5A is an enlarged cross-sectional view showing a usage example of the stylet according to modification 1, and FIG. The expanded sectional view which shows the usage example of this stylet, (C) is the expanded sectional view which shows the usage example of the stylet of the modification 3. 6A and 6B are diagrams showing each modification of the stylet according to the first embodiment. FIG. 6A is an enlarged cross-sectional view showing a usage example of the stylet according to modification 4, and FIG. The expanded sectional view which shows the usage example of this stylet, (C) is an expanded sectional view which shows the usage example of the stylet of the modification 6. FIG. 7A and 7B are diagrams showing each modification of the stylet according to the first embodiment. FIG. 7A is an enlarged cross-sectional view showing a usage example of the stylet according to the modification 7. FIG. FIG. 9C is an enlarged cross-sectional view showing a usage example of the stylet of FIG. FIG. 8 is a view showing a balloon catheter storage device according to the second embodiment, in which (A) is a perspective view of a stylet provided in the balloon catheter storage device, and (B) is an example of using the stylet. FIG. FIG. 9 is a diagram illustrating each modification of the stylet according to the second embodiment, (A) is an enlarged cross-sectional view illustrating a usage example of the stylet of modification 1, and (B) is a modification 2. The expanded sectional view which shows the usage example of the stylet of (1), (C) is the expanded sectional view which shows the usage example of the stylet of the modification 3, (D) is the enlarged cross section which shows the usage example of the stylet of the modification 4. FIG.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

<First Embodiment>
FIG. 1 is a diagram showing the configuration of each part of the balloon catheter storage device according to the first embodiment, FIG. 2 is a diagram showing a balloon catheter, and FIG. 3 is a balloon catheter assembly in a state of being accommodated in a packaging container. FIG. 4 is a diagram showing an example of use of a balloon catheter storage device.

  The balloon catheter storage device 200 according to this embodiment includes a stylet 10 and a balloon cover 100 as shown in FIG.

  The stylet 10 has a function as a core material for preventing the kink (bending) or the like from occurring in the balloon catheter 400 when the balloon catheter 400 is stored. The balloon cover 100 has a function as a protector that prevents the balloon 410 from being damaged by accommodating and protecting the balloon 410 of the balloon catheter 400.

  First, with reference to FIG. 2, the balloon catheter 400 used as the balloon catheter storage instrument 200 will be described. The balloon catheter 400 is described as an example of a usage target of the balloon catheter storage device 200, and the balloon catheter that is the usage target of the balloon catheter storage device 200 is limited to the configuration described here. Never happen.

  The balloon catheter 400 is a medical device that pushes and expands a stenosis by inserting the shaft 420 into a living organ and expanding the balloon 410 disposed on the distal end side of the shaft 420 at the stenosis (lesion). It is configured as a so-called PTCA dilatation catheter. However, the balloon catheter 400 may be used for other therapeutic applications. For example, the balloon catheter 400 may be a stenotic part formed in a living organ such as a blood vessel other than the coronary artery, a bile duct, a trachea, an esophagus, a urethra, or other organs. It may be a balloon catheter for the purpose of treatment and improvement.

  As shown in FIG. 2 (A), a balloon catheter 400 includes a long shaft 420 having flexibility, a balloon 410 arranged on the distal end side of the shaft 420 and capable of expanding and contracting, and a shaft. And a hub 450 arranged on the base end side of 420. In the description of the balloon catheter 400, the side on which the balloon 410 is provided is referred to as the distal end side, and the side on which the hub 450 is provided is referred to as the proximal end side.

  The balloon catheter 400 is a so-called rapid exchange type in which an opening 433 through which the guide wire 480 is led out is provided near the distal end side of the shaft 420. However, the balloon catheter 400 may be a so-called over-the-wire type balloon catheter formed such that the guide wire lumen 431 extends from the distal end of the shaft 420 to the proximal end.

  As shown in FIG. 2B, the shaft 420 is an inner tube (inner tube shaft) 430 formed with a guide wire lumen 431 through which the guide wire 480 is inserted, and a pressure medium for expanding the balloon 410. And an outer tube (outer tube shaft) 440 that forms the supplied pressurized medium lumen 441 with the outer peripheral surface of the inner tube 430.

  The shaft 420 has a double tube structure in which the inner tube 430 is inserted into the outer tube 440, and the inner tube 430 and the outer tube 440 are arranged concentrically.

  As shown in FIG. 2B, the inner tube 430 includes two openings, a distal end opening 433 formed at the distal end and a proximal end opening 435 formed at the proximal end. Inside the inner tube 430, a guide wire lumen 431 extends in communication with the openings 433 and 435.

  The inner tube 430 is configured by a hollow tube material whose proximal end is curved radially outward. Near the tip of the inner tube 430, the tip 413 of the balloon 410 is joined in a liquid-tight or air-tight manner by a known method such as welding. Further, the vicinity of the proximal end of the inner tube 430 is joined in a liquid-tight and air-tight manner with a connection opening 422 formed at a predetermined position of the outer tube 440. The guide wire 480 is inserted into the guide wire lumen 431 with the distal end opening 433 provided at the distal end of the inner tube 430 and the proximal end opening 435 provided at the proximal end of the inner tube 430 as inlets or outlets, respectively. The

  For example, when the tip of the balloon catheter 400 comes into contact with a living organ (such as the inner wall of a blood vessel), a tip can be attached to the tip of the inner tube 430 to prevent the living organ from being damaged. The distal tip can be constituted by, for example, a tubular member that is more flexible than the inner tube 430.

  Examples of the material constituting the inner tube 430 include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, thermoplastic resins such as soft polyvinyl chloride, silicone rubber, latex rubber, and the like. These various rubbers, various elastomers such as polyurethane elastomer, polyamide elastomer and polyester elastomer, and crystalline plastics such as polyamide, crystalline polyethylene and crystalline polypropylene can be used. In these materials, for example, an antithrombotic substance such as heparin, prostaglandin, urokinase, arginine derivative or the like can be blended to obtain a material having antithrombotic properties.

  The outer tube 440 is formed of a hollow tube material that extends from the vicinity of the base end 415 of the balloon 410 to the hub 450. Near the distal end of the outer tube 440, a proximal end portion 415 of the balloon 410 is joined in a liquid-tight manner by a known method such as welding.

  As the constituent material of the outer tube 440, for example, the same material as that of the inner tube 430 can be used. It is also possible to coat a portion of the outer tube 440 that comes into contact with blood (for example, the outer surface of the outer tube 440) with a substance having antithrombotic properties.

  As shown in FIG. 2A, the hub 450 includes a connection unit 451 that can be connected in a liquid-tight and air-tight manner to a supply device (not shown) such as an indeflator for supplying a pressurized medium. The connecting portion 451 of the hub 450 can be configured by, for example, a known luer taper configured such that a fluid tube or the like can be connected / separated.

  A pressurized medium (for example, physiological saline, contrast medium, etc.) used to expand the balloon 410 can be flowed into the shaft 420 via the connection portion 451 of the hub 450. The pressurized medium is supplied to the balloon 410 via the pressurized medium lumen 441.

  As shown in FIG. 2 (B), the balloon 410 includes an expansion effective portion (pressurizing portion) 416 that pushes the constriction portion in accordance with expansion deformation, a distal end side tapered portion 413a that continues to the distal end side of the expansion effective portion 416, A proximal end side tapered portion 415a that is continuous with the proximal end side of the effective expansion portion 416. The distal end portion 413 located on the distal end side of the distal end side tapered portion 413a is fixed to the outer surface of the inner tube 430, and the proximal end portion 415 located on the proximal end side of the proximal end side tapered portion 415a is outside the outer tube 440. It is fixed on the surface. An X-ray contrast marker indicating the central portion of the expansion effective portion 416 is provided in a portion located in the center of the expansion effective portion 416 in the inner tube 430. Note that the X-ray contrast markers may be provided at portions located at both ends of the expansion effective portion 416 in the inner tube 430 so as to indicate both end portions of the expansion effective portion 416.

  The constituent material of the balloon 410 is not particularly limited. For example, polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-acetic acid. Vinyl copolymers, thermoplastic resins such as polyurethane, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber, and the like can be used.

  Next, the stylet 10 and the balloon cover 100 included in the balloon catheter storage device 200 will be described.

  As shown in FIGS. 1B and 4A, the balloon cover 100 includes a lumen 111 into which the balloon 410 of the balloon catheter 400 is inserted, and can accommodate the balloon 410 in a folded state. It is configured. The state in which the balloon 410 is folded here means that, for example, after the balloon catheter 400 is manufactured, the balloon 410 is wound around the outer circumference of the inner tube 430 before actually starting to be used at a medical site or the like. The folded state. The shape of the balloon 410 when folded is not particularly limited, and a well-known folded shape in the medical field can be appropriately employed.

  As shown in FIG. 1B, the balloon cover 100 includes a hollow tubular tube including a distal end opening 113 that is continuous with the distal end side of the lumen 111 and a proximal end opening 115 that is continuous with the proximal end side of the lumen 111. It is comprised by the member.

  The balloon cover 100 can be made of an elastic material, for example. Examples of materials having elasticity include thermoplastic elastomers such as vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), and styrene-ethylene-propylene-styrene copolymer (SEPS). A thermoplastic resin such as nylon or PET, or a thermosetting resin such as rubber or silicone elastomer can be used.

  With reference to FIG. 1 (B), the length dimension (length in the axial direction) L3 of the balloon cover 100 can be formed to 10 to 80 mm, for example. However, the length dimension L3 of the balloon cover 100 is not particularly limited as long as the balloon cover 100 can be accommodated so as to surround the folded balloon 410 in the axial direction. It can be changed accordingly.

  The diameter d3 of the lumen 111 of the balloon cover 100 is such that when the balloon 410 is accommodated in the balloon cover 100, the outer surface of the balloon 410 is in contact with the inner surface 111a of the balloon cover 100 (see FIG. 4A). It is preferable that the dimensions be such that a certain amount of frictional force can be generated between the balloon 410 and the balloon cover 100. By forming the diameter d3 of the lumen 111 with such a size, it is possible to fix the balloon 410 to the balloon cover 100 using frictional force. However, if the frictional force becomes excessively large, when the balloon 410 is taken out from the balloon cover 100, an excessive pulling force may act on the balloon catheter 400, and the balloon catheter 400 may be stretched. The diameter d3 of the lumen 111 of the balloon cover 100 can be formed to an appropriate size according to the outer diameter of the balloon 410 in consideration of such points, for example, 0.40 to 2.00 mm. Can be formed.

  Note that the balloon cover 100 is not limited to the shape shown in FIG. For example, the base end portion of the balloon cover 100 may be formed in a tapered shape in which the diameter of the lumen 111 gradually increases toward the base end opening 115. By forming in such a shape, it becomes easy to insert the balloon 410 of the balloon catheter 400 into the balloon cover 100.

  As shown in FIGS. 1 (A) and 4 (A), the stylet 10 is formed on the base 20 that is inserted into the guide wire lumen 431 of the balloon catheter 400 and the distal end 23 side of the base 20 to form a balloon cover. And a bending portion (corresponding to a “fixing portion”) 30 that applies a fixing force for detachably fixing the stylet 10 to 100.

  In the description of the stylet 10, the extending direction (longitudinal direction) of the base portion 20 is referred to as the axial direction, the side on which the bending portion 30 is provided is referred to as the distal end side, and the side opposite to the side on which the bending portion 30 is provided is based on the side. It is called the end side. The distal end portion 23 of the base portion 20 indicates the vicinity of the boundary portion between the base portion 20 and the curved portion 30, and means a predetermined range including the distal end of the base portion 20. The base end portion 25 of the base portion 20 means a predetermined range including the base end of the base portion 20. Moreover, the X-axis attached | subjected to each figure shows the width direction (direction where the curved part 30 spreads) of the stylet 10, and the Y-axis shows the axial direction of the stylet 10 (the same direction as the axial direction of the base 20). . The Z axis is a direction orthogonal to the plane formed by the X axis and the Y axis, and indicates the thickness direction of the stylet 10.

  The stylet 10 is composed of one wire. The portion formed by adding a curved shape spreading outward to the axis A along the longitudinal direction of the base 20 with respect to the wire constitutes the curved portion 30, and the shape is added to the wire. The portion that does not exist, that is, the portion that extends substantially linearly in the axial direction constitutes the base portion 20. In this way, the base portion 20 and the bending portion 30 are integrally formed by one wire that is continuously connected to each other.

  As shown in FIG. 1 (A), the stylet 10 is configured to bend so that a portion on the distal end side of a portion of the wire 20 that is the base portion 20 is folded back toward the base end portion 25 side of the base portion 20. A folded portion 40 is provided. The bending portion 30 is configured by a portion extending from the folded portion 40 toward the base end portion 25 side of the base portion 20.

  The bending portion 30 has a curved shape so that the entire portion extends in the width direction (X direction). The curved portion 30 includes a first curved transition portion 31a, a second curved transition portion 31b, a sandwiching portion 33, and a tapered portion that are continuously connected from the folded portion 40 toward the proximal end portion 25 side of the base portion 20, respectively. 35.

  The 1st curve transition part 31a is the part formed in the position close | similar to the folding | returning part 40, and was curvedly shaped so that it might spread most in the width direction.

  The second curved transition portion 31b is a portion that is shaped so that the spread in the width direction gradually decreases as the distance from the folded portion 40 increases.

  The sandwiching portion 33 extends from the base end of the second curved transition portion 31b toward the base end portion 25 side of the base portion 20, and is shaped to be curved in a direction intersecting the axis A along the longitudinal direction of the base portion 20. Is the part that was made.

  The tapered portion 35 extends from the proximal end of the sandwiching portion 33 toward the proximal end portion 25 side of the base portion 20, and is shaped to be separated from the axis A of the base portion 20 as it is separated from the sandwiching portion 33. Part.

  As shown in FIGS. 1 (A) and 4 (A), the stylet 10 has a predetermined gap 33a between the sandwiching portion 33 and the base portion 20 in the unused state, and the tapered portion 35 and the base portion. There is also a predetermined gap 35 a between the first and second members 20. Further, a space portion 37 for accommodating the opening edge portion 113a of the distal end opening 113 of the balloon cover 100 is formed on the distal end portion 23 side of the base portion 20 with respect to the gap 33a between the sandwiching portion 33 and the base portion 20. ing.

  As shown in FIG. 4A, when the balloon catheter storage device 200 is used, the balloon cover 100 is disposed so as to cover (enclose) the balloon 410 in a folded state. On the other hand, the stylet 10 is partially inserted into the guide wire lumen 431 of the balloon catheter 400 at the base end portion 25 side of the base portion 20. The proximal end of the base portion 20 is led out of the guide wire lumen 431 through a proximal end opening 435 communicating with the proximal end of the guide wire lumen 431 of the balloon catheter 400. The base end of the base 20 of the stylet 10 is disposed in the guide wire lumen 431 without being led out of the guide wire lumen 431 via a base end opening 435 communicating with the base end of the guide wire lumen 431. May be.

  In addition, the stylet 10 is sandwiched between the base 20 and the sandwiching portion 33 so that the tube wall of the balloon cover 100 is sandwiched between the base 20 and the balloon cover 100 when the base 20 is inserted through the guide wire lumen 431. Force (fixing force) is applied. The entire stylet 10 is fixed to the balloon cover 100 through a fixing force that the base 20 and the clamping part 33 act on the tube wall of the balloon cover 100. The balloon catheter 400 is fixed to the balloon cover 100 by a frictional force that acts between the outer surface of the balloon 410 and the inner surface of the balloon cover 100. As a result, the balloon catheter 400 and the balloon cover 100 are fixed to each other, and the stylet 10 and the balloon cover 100 are fixed to each other, whereby the balloon catheter 400, the balloon cover 100, and the stylet 10 are assembled together. It becomes a state.

  The operation of attaching the stylet 10 to the balloon cover 100 is performed by attaching the distal end portion of the tube wall of the balloon cover 100 to the gap 35a between the tapered portion 35 and the base portion 20 and the sandwiching portion 33 as shown in FIG. And inserted into the space portion 37 through a gap 33a between the base portion 20 and the base portion 20. At this time, the tube wall of the balloon cover 100 is pushed into the space portion 37 until the opening edge portion 113 a of the tip opening portion 113 of the balloon cover 100 is inserted in the vicinity of the folded portion 40 of the stylet 10.

  The operation of attaching the stylet 10 to the balloon cover 100 includes, for example, a gap 33a between the holding portion 33 and the base portion 20 while gripping the outer surface of the balloon cover 100 and the curved portion 30 of the stylet 10 with fingers. It can be carried out by relatively moving one member of the balloon cover 100 and the stylet 10 toward the other member while expanding. Note that the above relative movement means that the balloon cover 100 is moved relative to the stylet 10, the stylet 10 is moved relative to the balloon cover 100, and the stylet 10 and the balloon cover 100 are moved. It means to include either operation of moving both.

  The operation of removing the stylet 10 from the balloon cover 100 is performed by releasing the state in which the tube wall of the balloon cover 100 is clamped by the base 20 and the clamping unit 33 of the stylet 10. Specifically, as in the operation of attaching the stylet 10 to the balloon cover 100, while holding each part of the balloon cover 100 and the stylet 10 with fingers or the like, one of the balloon cover 100 and the stylet 10 is held. The member is moved away from the other member. By performing this operation, the opening edge portion 113a of the tip opening portion 113 of the balloon cover 100 accommodated in the space portion 37 has a gap 33a between the sandwiching portion 33 and the base portion 20, and the taper portion 35 and the base portion. It moves so that it may pass through the clearance gap 35a between 20 in order. As a result, the holding of the tube wall of the balloon cover 100 by the base portion 20 and the holding portion 33 is released.

  The space 37 formed in the stylet 10 is closed at the front end side by the folded portion 40. For this reason, even when an attachment operation is performed or while the balloon 410 is being protected by the balloon cover 100, a force in the direction of moving the balloon cover 100 to the distal end side may be inadvertently applied. The opening edge 113a of the tip opening 113 abuts against the folded portion 40, and movement toward the tip is prevented. Thereby, it is possible to suitably prevent the balloon cover 100 from coming out to the tip side.

  The tapered portion 35 formed on the stylet 10 has a function as a guide portion that assists insertion when the tube wall of the balloon cover 100 is inserted into the gap 33a between the base portion 20 and the clamping portion 33. . As described above, the tapered portion 35 is shaped so that the base end side is gradually separated from the axis A of the base portion 20 toward the base end portion 25 side of the base portion 20. For this reason, when the stylet 10 is fixed to the balloon cover 100, when the opening edge 113 a of the tip opening 113 of the balloon cover 100 is moved toward the clamping part 33, the taper part 35 causes the clamping part 33 to The opening edge portion 113a is guided toward the gap 33a between the base portion 20 and the base portion 20. As a result, the opening edge 113a of the tip opening 113 of the balloon cover 100 can be easily inserted into the gap 33a between the sandwiching portion 33 and the base portion 20.

  The work of fixing the stylet 10 and the balloon cover 100 and the work of releasing the fixation are performed manually by a user (for example, a manufacturing worker or a medical worker) mainly at a manufacturing site or a medical site. Since the stylet 10 is manufactured on the assumption that it is attached to the balloon catheter 400 that is inserted into the living body lumen, the stylet 10 is generally configured with an outer diameter that requires some labor for visual confirmation. The For this reason, if the tip of the stylet 10 extends linearly, for example, when the stylet 10 is used in a medical field, the tip of the stylet 10 abuts against a glove worn by a medical worker or the like. The gloves may be damaged.

  For the above-described problem, the stylet 10 according to the present embodiment has a folded portion that is curved so as to be folded toward the proximal end portion 25 side of the base portion 20 at a portion corresponding to the distal end of the stylet 10. 40 is formed. By forming the folded portion 40, it is possible to prevent the tip of the stylet 10 from hitting a finger when handling the stylet 10. As a result, it is possible to prevent problems such as damage to the gloves from occurring.

  Further, when the stylet 10 is used, the distal end side of the stylet 10 can be easily checked by visually checking the positions of the curved portion 30 and the folded portion 40 that extend in the width direction (X-axis direction) from the base portion 20. It becomes possible to grasp. For this reason, the stylet 10 is easy to handle even in a manufacturing site or a medical site where quick work is required even though the stylet 10 is made of a relatively thin wire.

  The wire constituting the stylet 10 can be made of, for example, a known resin material or metal material having elasticity. If the wire is made of an elastic material, the stylet 10 can be attached to and detached from the balloon cover 100 while deforming the shape of each part of the stylet 10 to some extent. As a result, it is possible to handle (reuse) a wider variety of balloon covers 100 having different outer diameters with a single stylet 10, thereby improving the versatility of the stylet 10.

  Examples of the material constituting the wire include thermoplastics such as vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), and styrene-ethylene-propylene-styrene copolymer (SEPS). Use thermoplastic resins such as elastomer, nylon, and PET, thermosetting resins such as rubber and silicone elastomer, metal materials such as SUS wire, copper wire, titanium wire, and nitinol wire, and combinations of the above materials as appropriate. It is possible.

  Note that the stylet 10 according to the present embodiment is configured by one continuously extending wire to which a predetermined shape is added. For example, a plurality of wires are connected to configure one wire as a whole. A thing can also be used as a constituent member of the stylet 10. In the case where such a wire to which a plurality of wires are connected is used, the number of manufacturing steps of the stylet 10 is increased, so that the manufacturing operation is somewhat complicated, but the base 20 and the curved portion 30 of the stylet 10 are used. Since it is possible to use a desired material according to the function of each part, it is possible to improve the function of each part and to reduce the manufacturing cost by increasing the room for material selection.

  With reference to FIG. 1 (B), the length dimension (total length in the axial direction) L1 of the stylet 10 can be formed to 250 to 350 mm, for example, and the length dimension of the portion where the curved portion 30 is formed. L21 can be formed to 1 to 20 mm, for example, and the length L22 of the portion where the base 20 is formed can be formed to 230 to 249 mm, for example. Moreover, the dimension d1 of the part which spreads in the width direction most in the curved part 30 can be formed, for example to 1-3 mm, and the dimension d2 of the clearance gap 33a between the clamping part 33 and the base 20 is 0, for example. It can be formed to 0.5 mm. However, the dimensions of each part of the stylet 10 can be appropriately changed according to the specifications (dimensions, etc.) of the balloon catheter 400, the balloon cover 100, and the re-grooming cover 300 described later, and are limited to the above-described dimension examples. It will never be done.

  Moreover, the cross-sectional shape and outer diameter of the wire which comprises the stylet 10 are not specifically limited, either.

  Next, the rimming cover 300 will be described.

  Balloon catheters may be used multiple times in a single procedure. When the balloon catheter is used a plurality of times, the balloon is once expanded in order to treat the stenosis formed in the living body lumen, and then the balloon catheter is contracted, and the balloon catheter is taken out of the living body. Once the balloon of the balloon catheter is expanded and deformed from the folded state, the folded shape added at the time of manufacture is released, so that even if it is contracted, the diameter may not be sufficiently reduced to a desired outer diameter. If the outer diameter of the balloon cannot be reduced to a desired size, it will be difficult to reinsert the balloon catheter into the living body lumen. For this reason, in a medical field, the operation | work which shrinks | reduces a diameter of a balloon may be performed using the instrument called a cover for re-grooming (sheath for re-grooming). The balloon taken out of the living body is inserted into the re-grooming cover, and is reduced in diameter to a predetermined outer diameter according to the diameter of the lumen of the re-grooming cover. When the balloon is inserted into the re-grooming cover, a stylet is used as a core material for adding stiffness to the balloon catheter.

  As shown in FIG. 1B, the re-grooming cover 300 according to this embodiment includes a lumen 311 into which the balloon 410 is inserted, a tip opening 313 continuous with the tip side of the lumen 311, and a lumen 311. And a proximal end opening 315 that is continuous with the proximal end side. In addition, as a constituent material of the rimming cover 300, for example, the same materials as those exemplified as the constituent material of the balloon cover 100 described above can be used.

  With reference to FIG. 1B, the length dimension (length in the axial direction) L4 of the re-grooming cover 300 can be formed to 30 to 100 mm, for example. However, the length dimension L4 of the rimming cover 300 is not particularly limited as long as it can be accommodated so as to surround the deflated balloon 410 in the axial direction, and the axial length of the balloon 410 is not limited. It can be appropriately changed according to the dimensions.

  The diameter d4 of the inner cavity 311 of the re-grooming cover 300 can be formed to 0.5 to 3.0 mm, for example. The diameter d4 of the lumen 311 of the re-grooming cover 300 can be set as appropriate based on how much the outer diameter of the balloon 410 in the contracted state is reduced. In general, the balloon 410 that has been once expanded and then deflated has an outer diameter larger than that of the folded state (the state wound around the inner tube 430) because the folded shape given after manufacture has been unraveled. growing. The re-grooming cover 300 is used for the purpose of reducing the outer diameter of the balloon 410 to such an extent that the insertion into the living body lumen is ensured, so that the diameter d4 of the lumen 311 is excessively small. It is not necessary to set. For this reason, the diameter d4 of the lumen 311 of the re-grooming cover 300 is formed larger than the diameter d3 of the lumen 111 of the balloon cover 100 that houses the folded balloon 410.

  The re-grooming cover 300 is not limited to the shape shown in FIG. For example, similar to the balloon cover 100, the proximal end portion of the re-grooming cover 300 may be formed in a tapered shape in which the diameter of the lumen 311 gradually increases toward the proximal end opening 315. By forming in such a shape, the balloon 410 of the balloon catheter 400 can be easily inserted into the re-grooming cover 300.

  FIG. 4B shows a state when the rimming cover 300 is used.

  When the re-grooming cover 300 is used, the stylet 10 is used in the same manner as when the balloon cover 100 is used. The stylet 10 and the re-grooming cover 300 can be fixed by applying a fixing force to the tube wall of the re-grooming cover 300 via the curved part 30 (the pinching part 33 and the base 20) of the stylet 10. . When the balloon 410 is inserted into the lumen 311 of the re-grooming cover 300, the balloon 410 is pressed into the tube wall of the re-grooming cover 300 and reduced in diameter to a predetermined outer diameter corresponding to the diameter of the lumen 311. To do.

  The specific work procedure for fixing the rimming cover 300 and the stylet 10 and releasing the fixation is the same as the procedure for fixing the balloon cover 100 and the stylet 10 and releasing the fixation. Therefore, the description is omitted.

  As described above, the stylet 10 attached to the balloon cover 100 can be easily removed from the balloon cover 100 by releasing the mechanical fixing force that the curved portion 30 of the stylet 10 acts on the balloon cover 100. Can be removed (separated). For this reason, when the re-grooming cover 300 is used, the stylet 10 removed from the balloon cover 100 can be reused as it is for the re-grooming cover 300. Accordingly, it is possible to save the trouble of separately preparing a stylet dedicated to the balloon cover 100 and a stylet dedicated to the re-grooming cover 300 in a medical site where the balloon catheter 400 is used.

  The stylet 10 has a structure in which a fixing force is applied by sandwiching the tube wall of the balloon cover 100 or the tube wall of the re-grooming cover 300 between the base portion 20 and the sandwiching portion 33. Therefore, the stylet 10 exerts a sufficient fixing force that does not cause inadvertent detachment from the covers 100 and 300 regardless of differences in the diameters of the lumens 111 and 311 of the covers 100 and 300. be able to. That is, the stylet 10 can maintain its fixing function even when the stylet 10 is shared by a plurality of types of covers having different lumen diameters, such as the balloon cover 100 and the re-grooming cover 300.

  Here, an example has been described in which the stylet 10 is shared by the balloon cover 100 and the re-grooming cover 300. However, for example, the stylet 10 can be shared by a plurality of types of balloon covers 100. It is. For this reason, when a plurality of types of balloon covers 100 having different diameters of the lumens 111 are used in accordance with the types of balloons having different balloon diameters (variety types) at the production site of the balloon catheter, etc. It is no longer necessary to prepare a dedicated stylet as stock. Thereby, the cost required for manufacturing and managing the stylet 10 can be reduced, and as a result, the manufacturing cost of the balloon catheter storage device 200 including the stylet 10 as a constituent member can be reduced.

  Next, the balloon catheter assembly 500 will be described.

  In this embodiment, the balloon catheter assembly 500 includes a balloon catheter 400, a balloon catheter storage device 200 (the stylet 10 and the balloon cover 100), and a re-grooming cover 300.

  FIG. 3 shows a state where the balloon catheter assembly 500 is stored and distributed.

  When the balloon catheter assembly 500 is transported or stored after manufacture, the balloon catheter assembly 500 can be accommodated in a packaging container 510 called a peel bag. Further, the long shaft 420 of the balloon catheter 400 is accommodated in a wound state in a predetermined tubular member called a holder tube 520 having a lumen 521 in consideration of handling during transportation and storage. (See FIG. 4A). The balloon 410 disposed on the distal end side of the shaft 420 is also accommodated in the holder tube 520 in the same manner as the shaft 420.

  In this unused state, the balloon catheter 400 is protected by the balloon 410 being covered with the balloon cover 100 as shown in FIG. Thereby, it is possible to prevent the balloon 410 from being damaged by rubbing against the inner surface of the holder tube 520 or the like. 4A is an enlarged cross-sectional view showing the inside of the 4A portion shown in FIG.

  As shown in FIG. 3, the holder tube 520 includes a plurality of fixtures 523 for maintaining the holder tube 520 in a wound state, and a hub fixture 525 for fixing the hub 450 of the balloon catheter 400. , And a support 527 for detachably attaching the re-grooming cover 300.

  When inserting the balloon catheter 400 into the holder tube 520, first, the balloon 410 is inserted into the balloon cover 100. Next, the base 20 of the stylet 10 is inserted through the guide wire lumen 431 of the balloon catheter 400. Then, the stylet 10 is fixed to the balloon cover 100 by pushing the opening edge 113a of the tip opening 113 of the balloon cover 100 into the space 37 of the bending portion 30 located on the tip 23 side of the base 20. To do. After the balloon catheter 400, the balloon cover 100, and the stylet 10 are fixed to each other in this manner, the balloon catheter 400 is inserted into the lumen 521 of the holder tube 520 from the distal end side of the balloon catheter 400.

  As shown in FIG. 3, with the balloon cover 100 and the stylet 10 in a state where the unused balloon catheter 400 is protected, and the rimming cover 300 is attached to the holder tube 520, the balloon catheter assembly 500 is mounted. The packaging container 510 can be housed and packaged. The balloon catheter assembly 500 is sterilized in a state where the balloon catheter assembly 500 is accommodated in the packaging container 510 and packaged. The balloon catheter assembly 500 can be provided in a medical facility or a medical site in a packaged state.

  As described above, according to the balloon catheter storage device 200 according to the present embodiment, the stylet with respect to the balloon cover 100 is operated by operating fixing and releasing of the bending portion 30 formed on the stylet 10 and the balloon cover 100. 10 can be easily attached and separated, and the stylet 10 can be used in common with the balloon cover 100 and the re-grooming cover 300. Moreover, since the curved part 30 is formed by adding the shape which spreads outward with respect to the axis line A along the longitudinal direction of the base part 20 to the wire material which comprises the stylet 10, adding a fixing function Accordingly, it is possible to prevent an increase in the number of parts. Therefore, it is possible to provide a balloon catheter storage device 200 that can reduce the manufacturing cost and simplify the manufacturing operation and has improved convenience.

  In addition, the stylet 10 has a folded portion 40 that is configured to bend so that a portion on the distal end side with respect to the portion constituting the base portion 20 of the wire is folded toward the base end portion 25 side of the base portion 20. The curved portion 30 is formed closer to the proximal end portion 25 of the base portion 20 than the folded portion 40, is curved in a direction intersecting the axis A along the longitudinal direction of the base portion 20, and the balloon cover is formed between the curved portion 30 and the base portion 20. Since the holding portion 33 for applying a holding force to the tube wall 100 is provided, it is inadvertent even when the balloon cover 100 and the re-grooming cover 300 having different inner diameters are used. A sufficient fixing force that does not cause separation can be applied. In addition, since the folded portion 40 is formed on the stylet 10, it is possible to prevent problems such as damage to gloves worn by medical personnel when the stylet 10 is handled. Is possible.

  Further, the stylet 10 has a tapered portion 35 that extends toward the proximal end side from the sandwiching portion 33 and is separated from the axis A of the base portion 20 as it is separated from the sandwiching portion 33, so that the balloon cover 100 and the regrooming are performed. When the stylet 10 is fixed to the cover 300, the tube wall of each cover 100, 300 can be easily inserted between the sandwiching portion 33 and the base portion 20. The stylet 10 can be fixed easily and quickly.

  The balloon catheter storage device 200 (the balloon cover 100 and the stylet 10), the balloon catheter 400, and the re-grooming cover 300 are provided, and the stylet 10 is attached to the balloon cover 100 and the re-grooming cover 300. Thus, it is possible to provide a balloon catheter assembly 500 configured to be shared.

  Next, a modification of the stylet according to the first embodiment will be described. In the description of each modified example, the description of the same members as those already described, points that can be configured similarly, and the like will be omitted as appropriate. Further, in the description of each modification, a configuration or the like having the same function will be described in some modification examples, and the description thereof will be omitted as appropriate in other modification examples.

<Modification 1>
With reference to FIG. 5 (A), the stylet 610 which concerns on the modification 1 is demonstrated.

  The curved portion 30 of the stylet 610 is curved so as to be folded back from the folded portion 40 toward the proximal end portion 25 side of the base portion 20 and from the proximal end of the linear portion 611 toward the distal end portion 23 side of the base portion 20. It has the 2nd folding | turning part 612, the taper part 613 which continues to the 2nd folding | turning part 612, and the clamping part 614 which continues to the taper part 613.

  Even when the stylet 610 is used, the holding portion 614 and the base portion 20 cause the holding force to the tube wall of the balloon cover 100 and the tube wall of the re-grooming cover 300, so On the other hand, the stylet 610 can be mechanically fixed. Therefore, the stylet 10 can be easily attached to and detached from the covers 100 and 300, and the stylet 10 can be reused between the different types of covers 100 and 300.

  Note that the tapered portion 613 formed in the stylet 610 has a function of assisting insertion when a tube wall such as the balloon cover 100 is inserted into the gap between the sandwiching portion 614 and the base portion 20. Moreover, in the stylet 610, since the edge part 615 located in the front end side of the clamping part 614 is arrange | positioned so that it may face the linear part 611 side, when working with the stylet 610, the medical worker etc. attached It is possible to prevent the end 615 from hitting a glove or the like.

<Modification 2>
Next, a stylet 620 according to the second modification will be described with reference to FIG.

  The curved portion 30 of the stylet 620 includes a first straight portion 621 extending from the folded portion 40 toward the proximal end portion 25 of the base portion 20, and a first tapered portion 622 extending from the proximal end of the first straight portion 621 toward the base portion 20. A sandwiching portion 623 formed at the base end of the first taper portion 622, a second taper portion 624 extending from the sandwiching portion 623 toward the base end portion 25 side of the base portion 20, and a base portion from the base end of the second taper portion 624 20 and a second straight line portion 625 formed so as to be folded back toward the tip end portion 23 side.

  Even when the stylet 620 is used, the sandwiching portion 623 and the base portion 20 cause the sandwiching force to be applied to the tube wall of the balloon cover 100 and the tube wall of the re-grooming cover 300, so On the other hand, the stylet 620 can be mechanically fixed. The second taper portion 624 has a function of assisting insertion when a tube wall such as the balloon cover 100 is inserted into the gap between the sandwiching portion 623 and the base portion 20. In the stylet 620, since the second straight portion 625 is disposed on the linear extension of the first straight portion 621, the tip of the second straight portion 625 does not easily hit a finger or the like when the stylet 620 is handled. Become. Accordingly, it is possible to prevent the gloves or the like from being damaged when a medical worker or the like grips and handles the stylet 620.

<Modification 3>
Next, a stylet 630 according to Modification 3 will be described with reference to FIG.

  The curved portion 30 of the stylet 630 is formed closer to the proximal end portion 25 of the base portion 20 than the folded portion 40 and closer to the proximal end portion 25 of the base portion 20 than the first sandwiching portion 631. The second clamping portion 632 formed, the tapered portion 633 formed on the proximal end portion 25 side of the base portion 20 with respect to the second clamping portion 632, and the proximal end of the tapered portion 633 toward the distal end portion 23 side of the base portion 20 And a straight line portion 634 formed so as to be folded.

  Each of the holding portions 631 and 632 is formed by bending the wire constituting the stylet 630 into a wave shape so that the wire rod folds back and forth in a direction intersecting the axis A of the base portion 20.

  The distance (gap) between the first clamping part 631 and the base part 20 is formed to be different from the distance between the second clamping part 632 and the base part 20. For this reason, even when the stylet 630 is used for a plurality of types of balloon covers 100 and re-grooming covers 300 having different tube wall thicknesses, the second sandwiching portion 631 and the base portion 20 or the second By selectively inserting the tube walls of the respective covers 100 and 300 between the holding portion 632 and the base portion 20, it becomes possible to apply a sufficient holding force to the tube walls. That is, the stylet 630 is configured to be shared with the covers 100 and 300 having different tube wall thicknesses, and the convenience is further improved.

  The outer shape of each clamping part 631 and 632 is not limited to the curved wave shape as shown in the figure. For example, it is an outer shape that intersects the axis of the base 20 in a zigzag shape (linear shape). There may be. In addition, the number of holding portions provided in one stylet 630 is not limited to two, and three or more holding portions may be provided in one stylet 630. The distance between each clamping part and the base is not particularly limited, and can be set to an arbitrary dimension.

  When a plurality of sandwiching portions are provided in one stylet, for example, a plurality of sandwiching portions having the same distance from the base portion may be provided. If comprised in this way, since it becomes possible to make clamping force act on several places of a tube wall, the fixing force of the stylet with respect to each cover can be improved. Furthermore, for example, a single stylet may be connected to the base so that the function of sharing the stylet with a plurality of types of balloon covers and re-grooming covers having different tube wall thicknesses is not impaired. It is also possible to provide a plurality of sandwiching portions whose distances are set to be the same and a plurality of sandwiching portions whose distances to the base portion are different.

<Modification 4>
Next, a stylet 640 according to Modification 4 will be described with reference to FIG.

  The curved portion 30 of the stylet 640 includes a straight line portion 641 extending from the folded portion 40 toward the proximal end portion 25 side of the base portion 20, and a curved portion 30 bent so as to be folded back from the proximal end portion of the straight portion 641 toward the distal end portion 23 side of the base portion 20. A second folded portion 642 and an axial clamping portion 643 extending from the second folded portion 642 toward the distal end portion 23 side of the base portion 20.

  The axial clamping portion 643 extends substantially parallel to the base portion 20 when the stylet 10 is not used. When the stylet 640 is fixed to the balloon cover 100 or the re-grooming cover 300, the axial pinching portion 643 extends between the cover 100 and the base 20 over a predetermined range along the axis of the base 20. 300 tube walls are sandwiched. Therefore, compared to the clamping portions described in the above-described embodiments and modifications, the axial clamping portion 643 exerts a clamping force over a wider range of the tube walls of the covers 100 and 300. The fixing force of the stylet 640 with respect to the covers 100 and 300 can be increased.

  The length dimension in the axial direction of the axial clamping portion 643 can be appropriately set in consideration of the clamping force applied to the covers 100 and 300, and is not particularly limited.

  The second folded portion 642 formed on the stylet 640 has a function of assisting insertion when a tube wall such as the balloon cover 100 is inserted into the gap between the axial holding portion 643 and the base portion 20. . Further, in the stylet 640, since the tip 644 of the axial pinching portion 643 is arranged so as to face the inner surface of the folded portion 40, when the stylet 640 is handled, gloves or the like worn by medical workers or the like It is possible to prevent the tip 644 from striking against the head.

<Modification 5>
Next, a stylet 650 according to Modification 5 will be described with reference to FIG.

  The base portion 20 of the stylet 650 is formed with a first portion 651 extending in the longitudinal direction and a distal end side with respect to the first portion 651, and an axis (center axis) A2 is an axis (center axis) of the first portion 651. ) A second portion 652 disposed at a position eccentric to A1 and a transition portion 653 formed between the first portion 651 and the second portion 652.

  The curved portion 30 of the stylet 650 includes a balloon between a linear portion 654 extending from the folded portion 40 toward the proximal end portion 25 of the base portion 20, a tapered portion 655 connected to the linear portion 654, and a second portion 652 of the base portion 20. A clamping portion 656 that applies a clamping force to the tube wall of the cover 100.

  As shown in FIG. 6B, when the stylet 650 is used, the first portion 651 of the base portion 20 is disposed at the center position in the radial direction of the lumen 111 of the balloon cover 100, and the second portion 652 of the base portion 20 is used. Is arranged so as to be along the inner surface 111 a of the tube wall of the balloon cover 100, the axial center of the balloon catheter 400, that is, the axial center of the inner tube 430 can be positioned at the central position of the balloon cover 100. become. By arranging in this way, even when the outer diameter of the balloon cover 100 is formed to be large to some extent, the amount of deformation of the stylet 650 toward the tube wall side of the balloon cover 100 can be kept small. As a result, while the balloon catheter 400 is being stored, the balloon 410 is pressed against the inner surface 111a of the tube wall of the balloon cover 100 with excessive force, or the inner tube 430 of the balloon catheter 400 is bent. Can be prevented.

  In the stylet 610, the end portion 657 located on the distal end side of the sandwiching portion 656 is disposed so as to face the straight portion 654 side. Therefore, when handling the stylet 650, a glove worn by a medical worker or the like It is possible to prevent the end portion 657 from striking against.

  It should be noted that the number of each shaft portion (the first portion and the second portion) provided in the base portion 20, the axial length of each shaft portion, and the transition portion formed between the shaft portions are the axis of the base portion 20. The angle of inclination with respect to the angle is not limited to that shown in the figure.

<Modification 6>
Next, a stylet 660 according to Modification 6 will be described with reference to FIG.

  The curved portion 30 of the stylet 660 is folded back from the folded portion 40 toward the proximal end portion 25 side of the base portion 20, and from the proximal end of the axial sandwiching portion 661 toward the distal end portion 23 side of the base portion 20. And a second folded portion 662 that is curved in this manner.

  The axial pinching portion 661 has a shape that is gently curved so as to intersect the axis A of the base portion 20. When the stylet 640 is fixed to the balloon cover 100 or the re-grooming cover 300, the axial pinching portion 661 has a predetermined range along the axis of the base portion 20 and the respective covers 100, 300 between the base portion 20 and the base portion 20. Hold the tube wall. Therefore, the clamping force can be applied over a wider range of the tube wall of each cover 100, 300, so that the fixing force of the stylet 660 to each cover 100, 300 can be increased.

  In the stylet 660, the distal end 663 of the second folded portion 662 is shaped so as to extend toward the distal end side substantially in parallel with the axial clamping portion 661. Therefore, when the stylet 660 is handled, a medical worker It is possible to prevent the tip 663 from striking against a glove or the like worn by the person.

<Modification 7>
Next, a stylet 670 according to the modification example 7 will be described with reference to FIG.

  The curved portion 30 of the stylet 670 includes a curved transition portion 671 that extends from the folded portion 40 toward the proximal end portion 25 side of the base portion 20, a first sandwiching portion 672 that extends from the proximal end of the curved transition portion 671, And a second clamping part 673 extending from the base end of the first clamping part 672.

  Each clamping part 672 and 673 has a shape folded back so as to straddle the axis of the base part 20. When the stylet 670 is fixed to the balloon cover 100 or the re-grooming cover 300, each of the holding portions 672 and 673 holds the tube wall of the balloon cover 100 between the base portion 20. Accordingly, it is possible to apply a clamping force to a plurality of locations on the tube wall of each cover 100, 300, and thus it is possible to increase the fixing force of the stylet 670 with respect to each cover 100, 300.

  Note that the number of sandwiching portions provided in one stylet 670 is not limited to two, and three or more sandwiching portions can be provided in one stylet 670. The distance (interval) between each clamping part is not particularly limited, and can be set to an arbitrary dimension.

<Modification 8>
Next, a stylet 680 according to the modification 8 will be described with reference to FIG.

  The base portion 20 of the stylet 680 is formed with a first portion 681 extending in the longitudinal direction and a distal end side of the first portion 681, and the axis A2 is eccentric with respect to the axis A1 of the first portion 681. And a transition part 683 formed between the first part 681 and the second part 682.

  Since the first portion 681 and the second portion 682 are formed at the base portion 20 of the stylet 680, similarly to the stylet 650 according to the modified example 5 described above, the axial center of the balloon catheter 400 is located at the center position of the balloon cover 100. That is, the axial center of the inner tube 430 can be positioned and arranged. Thereby, it becomes possible to store the balloon catheter 400 while suitably preventing unnecessary loads from being applied to the respective portions of the balloon catheter 400.

  The curved portion 30 of the stylet 680 is formed with a space portion 684 that is substantially circular in plan view. Since the space portion 684 forms a closed space that is closed inside thereof, it is possible to prevent the covers 100 and 300 inserted into the space portion 684 from slipping out to the tip side of the stylet 680. Become. In addition, since the tip of the stylet 680 is formed in a rounded shape, when the stylet 680 is handled, the tip of the stylet 680 is prevented from hitting a glove or the like worn by a medical worker or the like. can do.

<Modification 9>
Next, a stylet 690 according to Modification 9 will be described with reference to FIG.

  The curved portion 30 of the stylet 690 has a sandwiching portion 691 and a tapered portion 692. The stylet 690 according to the present modification is different from the above-described stylet 10 (see FIG. 1A) in that a curved tip shape is added to the bending portion 30. Even when the stylet 690 having such a shape is used, the stylet 690 with respect to each of the covers 100 and 300 can be obtained by holding the tube wall of each of the covers 100 and 300 between the holding portion 691 and the base 20. Can be fixed.

  As described above, an example of the shape of the stylet provided in the balloon catheter storage device 200 according to the first embodiment has been described based on a plurality of modifications. The stylet includes a base, a folded portion, and a sandwiching portion. As long as it can be detachably attached to the balloon cover by sandwiching the tube wall of the balloon cover between the base portion and the sandwiching portion and applying a fixing force (holding force), the shape and the structure of each part Etc. are not particularly limited.

Second Embodiment
Next, with reference to FIGS. 8A and 8B, a stylet 700 provided in the balloon catheter storage device according to the second embodiment will be described. In the description of the stylet 700 according to the second embodiment, descriptions of points that can be configured similarly to the configuration described for the stylet according to the first embodiment and that have similar functions are omitted as appropriate. .

  The stylet described in the above-described embodiments and modifications is provided with a bending portion (clamping portion) as a configuration for applying a fixing force to the balloon cover 100 and the re-grooming cover 300 (FIG. 4A). See). On the other hand, the stylet 700 according to the present embodiment includes contact portions 731 and 732 that contact the inner surface of the tube wall of the balloon cover 100 or the re-grooming cover 300 to apply a fixing force instead of the holding portion. ing.

  As shown in FIG. 8A, the stylet 700 is formed on the base portion 720 inserted into the guide wire lumen 431 of the balloon catheter 400 and the distal end portion 723 side of the base portion 720. And a fixing portion 730 for applying a fixing force for detachably fixing the let 700. In addition, the base 720 and the fixing portion 730 are integrally configured by a wire.

  The fixed portion 730 of the stylet 700 has a plurality of contact portions 731 and 732 that are formed to spread outward (X-axis direction) away from the axis A along the longitudinal direction of the base 720. For convenience of explanation, the first contact portion 731 and the second contact portion 732 are referred to in order from the contact portion located on the distal end side of the stylet 700 to the contact portion located on the proximal end side.

  The first abutting portion 731 and the second abutting portion 732 are configured by linearly shaped portions that protrude linearly (zigzag) toward the outer side intersecting the axis A of the base portion 720. The first abutting portion 731 has a pair of protruding portions 731 a arranged at positions symmetrical with respect to the axis A of the base portion 720. Similarly, the second contact portion 732 has a pair of projecting portions 732 b disposed at positions symmetrical to the axis A of the base portion 720.

  On the distal end side of the first abutting portion 731, a drop prevention portion 733 that is curved in a convex shape toward the outer side intersecting the axis A of the base portion 720 is formed. The drop-off prevention unit 733 has a function of preventing the tip 735 of the stylet 700 from abutting against a glove or the like worn by a medical worker or the like when handling the stylet 700, or a balloon cover on the stylet 700 as described later. It has a function of preventing the balloon cover 100 from coming out of the stylet 700 when the 100 is attached.

  Each abutting portion 731 and 732 has an axis line of the base portion 720 so that one stylet 700 can be shared with a plurality of types of balloon covers 100, 100a, and 100b having different lumen diameters. The distances d6 and d7 from A to the portion in contact with the inner surface of the balloon cover tube wall are formed to be different from each other.

  As shown in FIG. 8B, when the stylet 700 is attached to the balloon cover 100, the drop prevention portion 733 has a part of the base end abutting against the opening edge 113 a of the distal end opening 113 of the balloon cover 100. To be arranged. Due to this contact, the slip-out preventing portion 733 prevents the balloon cover 100 from moving to the tip side and coming out. Further, by disposing the stopper 733 so as to be exposed from the tip opening 113 of the balloon cover 100, it is possible to easily perform operations such as removing the stylet 700 from the balloon cover 100.

  Further, when the first contact portion 731 is inserted into the balloon cover 100 when the stylet 700 is attached to the balloon cover 100, the first contact portion 731 is applied to the inner surface 111 a of the tube wall of the balloon cover 100. The projecting portion 731a located at the position is brought into contact with the balloon cover 100, and a frictional force is applied to the balloon cover 100. The stylet 700 is fixed to the balloon cover 100 through this frictional force.

  For example, when the stylet 700 is attached to the balloon cover 100a whose inner diameter is smaller than that of the balloon cover 100, the second abutting portion 732 abuts the protruding portion 732b on the inner surface of the tube wall of the balloon cover 100a. Let The second contact portion 732 fixes the stylet 700 to the balloon cover 100a by applying a frictional force between the protruding portion 732b and the balloon cover 100a. At this time, the first contact portion 731 located on the distal end side with respect to the second contact portion 732 functions as a removal prevention portion that prevents the balloon cover 100a from slipping out toward the distal end side.

  Further, the second abutting portion 732 is formed on the inner surface of the tube wall of the balloon cover 100b from the protruding portion 732b when the stylet 700 is attached to the balloon cover 100b having a smaller lumen diameter than the balloon cover 100a. Also, a frictional force is applied to the balloon cover 100b by bringing the portion located on the proximal end side into contact. As a result, the stylet 700 can be fixed to the balloon cover 100b having a smaller inner diameter. At this time, the protruding portion 732b of the second contact portion 732 functions as a removal prevention portion that prevents the balloon cover 100b from coming out to the distal end side.

  With reference to FIG. 8 (B), the length dimension (total length in the axial direction) L5 of the stylet 700 can be formed to 250 to 350 mm, for example, and the fixing portion 730 and the removal preventing portion 733 are formed. The length dimension L61 of the part can be formed to 3 to 30 mm, for example, and the length dimension L62 of the part in which the base 20 is formed can be formed to 220 to 347 mm, for example. In addition, the dimension d5 of the portion of the removal preventing portion 733 that is widest in the width direction (X-axis direction) can be, for example, 1.5 to 3 mm, and the first contact portion 731 is widest in the width direction. The dimension d6 of the portion that can be formed can be, for example, 1.0 to 1.5 mm, and the dimension d6 of the portion of the second contact portion 732 that is widest in the width direction is, for example, 0.5 to 1. It can be formed to 0 mm. However, the dimensions of each part of the stylet 700 can be appropriately changed according to the specifications (dimensions, etc.) of the balloon catheter 400, the balloon covers 100, 100a, 100b, the re-grooming cover 300, etc. It is not limited to examples.

  When using the stylet 700 described in the present embodiment, the stylet 700 is attached to and detached from the balloon cover 100 (detachment) by operating fixing and releasing of the fixing portion 730 and the balloon cover 100. Can be easily performed. In addition, since the fixing portion 730 is formed by adding a shape spreading outward to the axis A along the longitudinal direction of the base 720 to the wire constituting the stylet 700, the fixing function is added. Accordingly, it is possible to prevent an increase in the number of parts. For this reason, as with each stylet described in the first embodiment, by using the stylet 700, it is possible to reduce the manufacturing cost and simplify the manufacturing operation, and to improve the convenience of the balloon. A catheter storage device 200 can be provided.

  Further, since the fixing portion 730 has an abutting portion that abuts the outer surface against the inner surface 111 a of the tube wall of the balloon cover 100, a simple operation of inserting the fixing portion 730 of the stylet 700 into the balloon cover 100 is performed. The stylet 700 can be fixed to the balloon cover 100 by using a frictional force acting between the outer surface of the contact portion and the inner surface 111a of the tube wall of the balloon cover 100.

  The fixing portion 730 includes a plurality of contact portions 731 and 732, and each of the contact portions 731 and 732 extends from the axis A of the base portion 720 to a portion that contacts the inner surface of the balloon cover tube wall. Since the distances d6 and d7 are formed so as to be different from each other, one stylet 700 can be shared for a plurality of types of balloon covers 100, 100a, and 100b having different lumen diameters. This is a further improvement.

  Moreover, since each contact part 731 and 732 is comprised by the linear-shaped part which protruded linearly toward the outer side which cross | intersects the axis A of the base part 720, it is in the wire which is a structural member of the stylet 700. On the other hand, the stylet 700 can be provided with a fixing function by a simple operation of adding a predetermined shape.

  In addition, each contact part 731 and 732 can also be formed in the rounded curved shape like the fall prevention part 133, for example.

  Next, a modified example of the stylet according to the second embodiment will be described. In the description of each modified example, the description of the same members as those already described, points that can be configured similarly, and the like will be omitted as appropriate. Further, in the description of each modification, configurations and the like having similar functions will be described in some modification examples, and description thereof will be omitted as appropriate in other modification examples.

<Modification 1>
With reference to FIG. 9 (A), the stylet 810 which concerns on the modification 1 is demonstrated.

  The fixed portion 730 of the stylet 810 includes a first contact portion 811 and a second contact portion that are each configured by a linear portion that protrudes linearly toward the outer side intersecting the axis A of the base portion 720. 812 and a third contact portion 813.

  The first contact portion 811 is formed to have a larger dimension in the width direction (a direction away from the axis of the base portion 20) than the second contact portion 812. The second contact portion 812 is a third contact portion. The size in the width direction is larger than 813. Since the dimensional relationship between the contact portions 811, 812, and 813 is set as described above, the stylet 810 is shared by a plurality of balloon covers 100, 100 a, and 100 b having different lumen diameters. Can do.

  As shown in FIG. 9A, when the stylet 810 is fixed to the balloon cover 100 when the stylet 810 is used, the outer surface of the first abutting portion 811 is made to face the inner surface of the tube wall of the balloon cover 100. To cause frictional force to act. Further, when the stylet 810 is fixed to the balloon cover 100a formed with a smaller inner diameter than the balloon cover 100, the outer surface of the second contact portion 812 is made to face the inner surface of the tube wall of the balloon cover 100a. Make contact. Further, when the stylet 810 is fixed to the balloon cover 100b formed with a smaller lumen diameter than the balloon cover 100a, the outer surface of the third contact portion 813 is set to the inner surface of the tube wall of the balloon cover 100b. Make contact with each other.

  As described above, by selectively using the abutment portions 811, 812, and 813, one stylet 810 is shared by a plurality of types of balloon covers 100, 100a, and 100b having different lumen diameters. be able to.

  The tip 815 of the stylet 810 has a shape that is bent so as to extend in a direction orthogonal to the base 720. For this reason, when handling the stylet 810, it can prevent that the front-end | tip 815 bumps into the glove etc. which the medical worker etc. wore. Further, the tip 815 of the stylet 810 functions as a removal preventing portion that prevents the balloon cover 100 from coming off when the stylet 810 is fixed to the balloon cover 100 via the first contact portion 811.

<Modification 2>
Next, with reference to FIG. 9B, a stylet 820 according to the second modification will be described.

  The fixed portion 730 of the stylet 820 includes a first abutting portion 822 and a second abutting portion 824 that are formed by extending portions that extend substantially parallel to the base portion 720 at positions spaced from the axis A of the base portion 720. doing.

  Between the first contact part 822 and the second contact part 824, a first transition part 822a extending in a direction away from the axis A of the base part 720 is formed, and the second contact part 824 is formed. A second transition portion 824a extending obliquely in a direction away from the axis A of the base portion 720 is formed between the base portion 720 and the base portion 720.

  As shown in FIG. 9B, when the stylet 820 is used, when the stylet 820 is fixed to the balloon cover 100, the outer surface of the first contact portion 822 is connected to the inner surface 111a of the tube wall of the balloon cover 100. A frictional force is applied by abutting against each other. Since the first contact portion 822 contacts the inner surface 111a of the tube wall of the balloon cover 100 over a predetermined range in the axial direction, the fixing force of the stylet 820 to the balloon cover 100 is improved. Further, when the stylet 820 is fixed to the balloon cover 100 a having a smaller inner diameter than the balloon cover 100, the outer surface of the second contact portion 824 is made to face the inner surface 111 a of the tube wall of the balloon cover 100. To touch. Similar to the first contact portion 822, the second contact portion 824 contacts the inner surface 111a of the tube wall of the balloon cover 100 over a predetermined range in the axial direction, and thus the stylet 820 is fixed to the balloon cover 100. The power can be improved.

  As described above, by selectively using the contact portions 822 and 824, one stylet 820 can be shared by a plurality of types of balloon covers 100 and 100a having different lumen diameters.

  Note that the tip 825 of the stylet 820 is formed in a rounded shape in plan view. For this reason, when the stylet 820 is handled, it is possible to prevent the tip 825 from hitting a glove or the like worn by a medical worker or the like. In addition, the tip 825 of the stylet 820 functions as a removal prevention portion that prevents the balloon cover 100 from coming off when the stylet 820 is fixed to the balloon cover 100 via the first contact portion 822.

<Modification 3>
Next, with reference to FIG. 9C, a stylet 830 according to the third modification will be described.

  The fixing portion 730 of the stylet 830 has an abutting portion 831 formed of a curved portion that is bent in a convex shape by folding the wire constituting the stylet 830 toward the base end portion 725 side of the base portion 720. .

  As shown in FIG. 9C, when the stylet 830 is used, when the stylet 830 is fixed to the balloon cover 100, the outer surface of the abutting portion 831 is made to face the inner surface 111a of the tube wall of the balloon cover 100. By bringing them into contact, a frictional force is applied. Thereby, the stylet 830 can be attached to the balloon cover 100 in a detachable manner. Further, when the stylet 830 is fixed to the balloon cover 100a having a smaller inner diameter than the balloon cover 100, the outer surface of the proximal end portion of the abutting portion 831 is placed on the inner surface of the tube wall of the balloon cover 100a. By abutting against each other, the stylet 830 can be fixed to the balloon cover 100a. At this time, the distal end portion of the contact portion 831 functions as a removal prevention portion that prevents the balloon cover 100a from coming off.

  Since the stylet 830 shown in this modification has a simple structure in which the shape of the stylet 830 is simply bent and added to one shape, the manufacturing operation can be further simplified. In addition, the manufacturing cost can be reduced.

  Note that the distal end 835 of the stylet 830 has a curved shape that is folded back toward the base end 725 side of the base 720, and therefore, when handling the stylet 830, gloves or the like worn by medical personnel or the like It is possible to prevent the front end 835 from abutting against the head.

<Modification 4>
Next, a stylet 840 according to Modification 4 will be described with reference to FIG.

  The fixed portion 730 of the stylet 840 has an abutting portion 841 formed of a curved shape portion that is bent in a convex shape by folding the wire constituting the stylet 840 toward the base end portion 725 of the base portion 720. .

  When the stylet 840 is used, a frictional force is applied by bringing the outer surface of the contact portion 841 into contact with the inner surface 111 a of the tube wall of the balloon cover 100. Thereby, the stylet 840 can be attached to the balloon cover 100 in a detachable manner. Further, when the stylet 840 is fixed to the balloon cover 100a having a smaller inner diameter than the balloon cover 100, the outer surface of the proximal end portion of the abutting portion 841 is placed on the inner surface of the tube wall of the balloon cover 100a. By abutting against each other, the stylet 840 can be fixed to the balloon cover 100a.

  Since the stylet 840 shown in the present modification has a relatively simple structure like the stylet 830 according to the modification 3, the manufacturing work can be simplified and the manufacturing cost can be reduced.

  Note that the distal end 845 of the stylet 840 has a curved shape that is folded back toward the base end 725 side of the base 720, and therefore, when handling the stylet 840, gloves or the like worn by medical personnel or the like It is possible to prevent the tip 845 from striking against the head. Further, the tip 845 of the stylet 840 functions as a removal preventing portion that prevents the balloon cover 100 from coming off when the stylet 840 is fixed to the balloon cover 100 via the contact portion 841.

  As described above, an example of the shape of the stylet provided in the balloon catheter storage device 200 according to the second embodiment has been described based on a plurality of modified examples. However, the stylet includes a base portion, a contact portion, and the like. Provided, by contacting at least a part of the outer surface of the abutting portion against the tube wall of the balloon cover and applying a fixing force (friction force), the shape and The structure of each part is not particularly limited.

  In addition, although description was abbreviate | omitted, the stylet which concerns on 2nd Embodiment and each modification is combined with the balloon catheter, the balloon cover, and the cover for re-grooming similarly to the stylet which concerns on 1st Embodiment. Can be provided as a balloon catheter assembly.

  As described above, the balloon catheter storage device and the balloon catheter assembly according to the present invention have been described through a plurality of embodiments and modifications. However, the present invention is not limited to the configuration described in the embodiments, and Changes can be made as appropriate based on the description of the range.

10, 610, 620, 630, 640, 650, 660, 670, 680, 690 stylet,
20 bases,
23 The tip of the base,
25 proximal end of the base,
30 Curved part (fixed part),
33 clamping part,
35 taper part,
40 Folding part,
100, 100a, 100b balloon cover,
111 lumen of the balloon cover,
111a The inner surface of the tube wall of the balloon cover,
200 Balloon catheter storage device,
300 cover for re-grooming,
311 lumen of the rimming cover,
400 balloon catheter,
410 balloon,
420 shaft,
430 inner pipe,
431 Guidewire lumen,
440 outer tube,
450 hub,
500 balloon catheter assembly,
614, 623, 656, 691 clamping part,
631, 672 first clamping part (clamping part),
632, 673 second clamping part (clamping part),
643, 661, 685 axial clamping part,
651, 681 first part,
652, 682 second part,
653, 683 transition part,
700, 810, 820, 830, 840 stylet,
720 base,
723, the tip of the base,
725, proximal end of the base,
730 fixing part,
731 1st contact part (linear shape part),
732 second contact portion (linearly shaped portion),
733 omission prevention part,
811 1st contact part (linear shape part),
812 second contact portion (linearly shaped portion),
813 3rd contact part (linear shape part),
822 first contact portion (extension portion),
824 second contact portion (extension portion),
831, 841 Abutting portion (curved shape portion)
A Base axis,
A1, the axis of the first part,
A2 The axis of the second part.

Claims (10)

A balloon catheter storage device used for storing a balloon catheter,
A balloon cover having a lumen into which the balloon of the balloon catheter is inserted, and housing the balloon in a folded state;
A stylet removably attached to the balloon cover,
The stylet is
A base portion inserted through the guide wire lumen of the balloon catheter, and formed on the distal end side of the base portion in a shape spreading outward with respect to an axis along the longitudinal direction of the base portion; A balloon catheter storage device comprising: a fixing portion that applies a fixing force that removably fixes the stylet; and wherein the base portion and the fixing portion are integrally formed of a wire. The stylet is
In the wire, it has a folded portion configured to be bent so as to be folded back toward the proximal end portion side of the base portion than the portion constituting the base portion,
The fixing part is
It is formed on the base end side of the base portion with respect to the folded portion, curved in a direction intersecting with the axis along the longitudinal direction of the base portion, and sandwiched between the base portion and the tube wall of the balloon cover The balloon catheter storage device according to claim 1 , further comprising a holding portion that applies force.   The balloon stylet storage device according to claim 2, wherein the stylet has a tapered portion that extends toward the proximal end side from the sandwiching portion and is spaced apart from the axis of the base portion as it is separated from the sandwiching portion. . The fixing portion has a plurality of the sandwiching portions formed by bending the wire rod a plurality of times in a direction intersecting the axis of the base portion.
The balloon catheter storage device according to claim 2 or 3, wherein each of the plurality of holding portions has a different distance from the base portion.   The balloon catheter storage device according to any one of claims 2 to 4, wherein the clamping unit includes an axial clamping unit that applies a clamping force over a predetermined range along the axis of the base.   The base portion is a first portion that extends in the longitudinal direction, and a second portion that is formed on the distal end side of the first portion, and in which a shaft center is disposed at a position that is eccentric with respect to the shaft center of the first portion. The balloon catheter storage device according to claim 2, further comprising: a transition portion formed between the first portion and the second portion.   The balloon catheter storage device according to claim 1, wherein the fixing portion has an abutting portion that abuts at least a part of an outer surface against an inner surface of a tube wall of the balloon cover. The fixed portion has a plurality of the contact portions,
The balloon catheter storage device according to claim 7, wherein each of the plurality of contact portions has a different distance from an axis of the base portion to a portion that is in contact with the inner surface of the tube wall.   The contact portion is a curved shape portion that is convexly curved toward an outer side that intersects the axis of the base, and a linear shape portion that projects linearly toward the outer side that intersects the axis of the base. The balloon catheter storage device according to claim 7 or 8, further comprising at least one of an extending portion extending substantially parallel to the base portion at a position spaced from the axis of the base portion. The balloon catheter storage device according to any one of claims 1 to 9,
The balloon catheter;
A balloon catheter assembly, comprising: a re-grooming cover that includes a lumen having a diameter larger than that of the balloon cover and to which the stylet is detachably fixed.