JP6525655B2 - Balloon catheter assembly - Google Patents

Description

  The present invention relates to a balloon catheter assembly comprising a balloon catheter and a balloon catheter storage instrument.

  As a tool used when storing a balloon catheter, a stylet (core material) inserted into the guide wire lumen of the balloon catheter, and a balloon cover (protective sheath) for covering and protecting the balloon in a folded state It is known to provide.

  For example, as described in Patent Document 1 below, a conventional storage device brings the inner surface of the balloon cover into contact with the outer surface of the balloon of the balloon catheter when the balloon is inserted into the balloon cover, and the balloon By utilizing the frictional force acting between the cover and the balloon, the relative positional relationship between the balloon cover and the balloon catheter can be maintained.

Unexamined-Japanese-Patent No. 2011-255086

  However, when using a storage device that maintains the positional relationship between the balloon cover and the balloon by utilizing the frictional force acting on the balloon cover, the product specifications of the balloon (balloon length and balloon, etc.) are secured to ensure proper frictional force. The balloon cover should be selected to have the appropriate dimensions according to the diameter).

  For example, if the frictional force is set too high, the withdrawal resistance of the balloon to the balloon cover will be too high, and therefore the pulling force applied to the balloon catheter should be intensified when performing the operation of withdrawing the balloon. As a result, the shaft of the balloon catheter may be stretched during operation. On the other hand, when the frictional force is set to be too small, the balloon cover is easily displaced from the balloon because the resistance to removal of the balloon to the balloon cover becomes excessively small, and the original purpose of protecting the balloon It will be difficult to achieve.

  Therefore, when using the conventional storage apparatus as described above, it is necessary to prepare in advance a plurality of types of balloon covers at a manufacturing site etc. so as to be compatible with a plurality of types of balloons of different types. Every time the cover is attached, it is necessary to select a suitable size from a plurality of balloon covers. As a result, the cost required for the production and maintenance of the balloon cover increases, and the operation of attaching the storage device to the balloon catheter also requires a great deal of effort.

  The present invention has been made in view of the above problems, and is an economical tool for storing balloon catheters which is excellent in economics and can be quickly and easily attached to a balloon. It is an object of the present invention to provide a balloon catheter assembly comprising: and a balloon catheter stored by the balloon catheter storage device.

The balloon catheter assembly according to the present invention comprises an outer tube forming a pressurized medium lumen through which a pressurized medium can flow between an inner tube shaft having a guide wire lumen through which a guide wire can be inserted and the inner tube shaft. A balloon catheter comprising a shaft, a distal end connected to the inner tube shaft, a proximal end connected to the outer tube shaft, and a balloon expandable and contractible by the inflow and discharge of the pressurized medium; A balloon catheter storage device including a balloon cover for forming the lumen in which the catheter is inserted and housing the balloon in a folded state, and a stylet inserted through the guide wire lumen; And the locking portion for restricting the movement of the balloon cover and an axis line along the longitudinal direction of the stylet. Curved in the direction of the guide in the inserted state into the wire lumen in contact with the inner surface of the inner tube shaft have a curved portion for applying a frictional force, the bending portion includes a proximal end portion of the balloon It is characterized in that it contacts the inner surface of the inner tube shaft at a more proximal position .

  According to the balloon catheter assembly of the present invention, the friction force acting between the curved portion formed on the stylet provided in the balloon catheter storage tool and the inner tube shaft of the balloon catheter It becomes possible to hold relative positional relationship. The balloon cover provided in the balloon catheter storage device is restricted in axial movement by the locking portion formed on the stylet. Thus, the balloon catheter assembly according to the present invention can maintain the relative positional relationship between the balloon cover and the balloon catheter. For this reason, it is possible to give a certain width (margin) to the design size of the lumen of the balloon cover, and it becomes possible to cope with a plurality of types of balloons of different types with one type of balloon cover. As a result, it is possible to suppress complication of the work of attaching to the balloon, and it is possible to suppress an increase in cost required for production and maintenance of a plurality of types of balloon covers. Therefore, a balloon catheter storage instrument excellent in economics and capable of performing a balloon attachment operation quickly and easily, and a balloon catheter stored using the storage instrument are provided. It becomes possible to provide a balloon catheter assembly.

1 is a schematic perspective view of a balloon catheter assembly according to an embodiment. It is a figure showing a balloon cover and stylet of a balloon catheter storage instrument concerning an embodiment, (A) is a sectional view of a balloon cover, and (B) is a top view of a stylet. FIG. 3 is a view showing a balloon catheter according to the embodiment, (A) is a view showing the overall configuration of the balloon catheter in a simplified manner, and (B) is an enlarged cross sectional view showing the tip side of the balloon catheter. . FIG. 5 is a view showing the balloon catheter assembly in a packaging container. It is a figure for demonstrating the usage example of the instrument for balloon catheter storage which concerns on embodiment, Comprising: It is an expanded sectional view which shows a mode when a balloon is accommodated in a balloon cover. It is a figure which shows the balloon catheter storage instrument which concerns on a modification. It is a general appearance perspective view of the balloon catheter assembly which concerns on a modification. FIG. 8 is a view showing a balloon cover according to a modification, wherein (A) is a schematic perspective view of a balloon catheter assembly provided with the balloon cover according to the modification, and (B) is a balloon cover according to the modification. FIG.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. The dimensional ratios in the drawings are exaggerated for the convenience of description, and may differ from the actual ratios.

  FIG. 1 is a schematic perspective view showing a balloon catheter assembly according to an embodiment, FIG. 2 is a view showing a balloon cover and a stylet provided for a balloon catheter storage instrument, and FIG. 3 is a balloon catheter according to the embodiment. FIG. 4 is a view showing the balloon catheter assembly in a state of being stored in a packaging container, and FIG. 5 is a view showing an example of use of the balloon catheter storage device.

  As shown in FIG. 1, a balloon catheter assembly 500 according to the present embodiment is configured of a balloon catheter 400 and a balloon catheter storage device 200. Further, the balloon catheter storage device 200 is provided with the stylet 10 and the balloon cover 100.

  The stylet 10 has a function as a core material for preventing the occurrence of kinks or the like in the balloon catheter 400 when the balloon catheter 400 is stored. The balloon cover 100 functions as a protector (protective sheath) that prevents damage such as a wound from occurring in the balloon 410 by housing and protecting the balloon 410 of the balloon catheter 400.

  First, referring to FIG. 3, a balloon catheter 400 to be used for the balloon catheter storage device 200 will be described. The balloon catheter 400 is described as an example of the use object of the balloon catheter storage device 200, and the balloon catheter to be used of the balloon catheter storage device 200 is limited to the configuration described here. There is nothing to do.

  The balloon catheter 400 is a medical device that spreads and treats a narrowed portion 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 narrowed portion (lesion). .

  In the present embodiment, the balloon catheter 400 is configured as a balloon catheter for treating a stenosis formed in an artery running in the lower limbs of a living body. However, the balloon catheter 400 is configured to be used for the treatment and improvement of a stenosis formed in a living organ such as, for example, a coronary artery and other blood vessels, bile ducts, trachea, esophagus, urethra and other organs. You may

  Generally, a constriction portion formed in the artery of the lower leg, which causes the onset of obstructive arteriosclerosis of the lower leg, etc., is longer along the extending direction of the blood vessel than a constriction portion formed in a coronary artery or the like. For this reason, the balloon 410 provided in the balloon catheter 400 is formed such that its axial length L3 is longer than the balloon of a balloon catheter used in a coronary artery or the like. The axial length L3 of the balloon 410 can be, for example, 20 to 200 mm.

  As shown in FIG. 3 (A), the balloon catheter 400 comprises an elongated shaft 420 having flexibility, an expandable / contractible deformable balloon 410 disposed on the distal end side of the shaft 420, and a shaft And a hub 450 disposed on the proximal side of 420. In the description of the balloon catheter 400, the side provided with the balloon 410 is referred to as the distal end side, the side provided with the hub 450 is referred to as the proximal end side, and the extending direction of the shaft 420 is referred to as the axial direction.

  The balloon catheter 400 is a so-called rapid exchange type in which an opening 435 from which the guide wire 480 is led out is provided near the tip of the shaft 420. However, the balloon catheter 400 can also be configured as a so-called over-the-wire type balloon catheter in which the guide wire lumen 431 is formed to extend from the distal end to the proximal end of the shaft 420.

  As shown in FIG. 3B, the shaft 420 is provided with an inner tube shaft 430 formed with a guide wire lumen 431 through which the guide wire 480 is inserted, and a pressure medium supplied with a pressure medium for expanding the balloon 410. And an outer tube shaft 440 forming a pressure medium lumen 441 with the outer peripheral surface of the inner tube shaft 430.

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

  As shown in FIG. 3 (B), the inner tube shaft 430 has two openings of 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 shaft 430, a guide wire lumen 431 extends in communication with the openings 433, 435.

  The inner tube shaft 430 is formed of a hollow tube material whose proximal end is curved radially outward. In the vicinity of the tip of the inner tube shaft 430, the tip portion 413 of the balloon 410 is joined in a fluid-tight and air-tight manner by a known method such as welding. Further, the vicinity of the proximal end of the inner pipe shaft 430 is joined in a fluid tight and airtight manner to a connection opening 422 formed at a predetermined position of the outer pipe shaft 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 shaft 430 and the proximal end opening 435 provided at the proximal end of the inner tube shaft 430 as an inlet or outlet. It is inserted.

  At the tip of the inner tube shaft 430, for example, it is possible to attach a tip that prevents damage to a living organ when the tip of the balloon catheter 400 contacts the living organ (such as the inner wall of a blood vessel). . The distal tip can be configured, for example, by a tubular member that is more flexible than the inner tube shaft 430.

  Examples of the material constituting the inner tube shaft 430 include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc. thermoplastic resins such as soft polyvinyl chloride, silicone rubber, latex rubber And various elastomers such as polyurethane elastomer, polyamide elastomer and polyester elastomer, and crystalline plastics such as polyamide, crystalline polyethylene and crystalline polypropylene. In these materials, for example, antithrombotic substances such as heparin, prostaglandin, urokinase, arginine derivatives and the like can be blended to make the material have antithrombotic properties.

  The outer tube shaft 440 is formed of a hollow tubular material extending from near the proximal end 415 of the balloon 410 to the hub 450. Near the tip of the outer tube shaft 440, the proximal end 415 of the balloon 410 is fluidly and airtightly joined by a known method such as welding.

  As a constituent material of the outer tube shaft 440, for example, the same material as the inner tube shaft 430 can be used. In addition, it is possible to coat an anti-thrombogenic substance on the portion of the outer tube shaft 440 in contact with blood (for example, the outer surface of the outer tube shaft 440).

  As shown in FIG. 3A, the hub 450 is provided with a supply unit (not shown) such as an indeflator for supplying a pressurized medium and a connection portion 451 connectable in a fluid-tight and airtight manner. The connection portion 451 of the hub 450 can be configured by, for example, a known luer taper or the like in which a fluid tube or the like can be connected and separated.

  Pressurized media (eg, saline, contrast media, etc.) used to expand the balloon 410 can flow into the shaft 420 through the connection 451 of the hub 450. Pressurized media is supplied to the balloon 410 via the pressurized media lumen 441.

  As shown in FIG. 3B, the balloon 410 has an expansion effective portion (pressurizing portion) 416 which spreads the narrowed portion along with the expansion deformation, and a distal end side taper portion 413a connected to the distal end side of the expansion effective portion 416; And a proximal end taper portion 415a connected to the proximal end side of the expansion effective 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 shaft 430, and the proximal end portion 415 located on the proximal end side of the proximal end tapered portion 415a is an outer tube It is fixed to the outer surface of the shaft 440.

  In a portion of the inner tube shaft 430 located at the center of the expansion effective portion 416, an X-ray contrast marker indicating the center portion of the expansion effective portion 416 is provided. Note that the X-ray contrast marker may be provided on the portion of the inner tube 430 located at both ends of the expansion effective portion 416 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, crosslinked ethylene-acetic acid A vinyl copolymer, a thermoplastic resin such as polyurethane, a polyamide elastomer, a polystyrene elastomer, a silicone rubber, a latex rubber, and the like can be used.

  Next, the balloon cover 100 provided in the balloon catheter storage device 200 will be described.

  As shown in FIGS. 1 and 5, the balloon cover 100 includes a lumen 111 into which the balloon 410 of the balloon catheter 400 is inserted, and is configured to be able to store the balloon 410 in a folded state. There is. In the folded state of the balloon 410 referred to here, for example, the balloon 410 can be wound around the outer periphery of the inner tube shaft 430 until the balloon catheter 400 is manufactured and actually used at a medical site or the like. It is in a folded state. The shape of the balloon 410 when folded is not particularly limited, and any known folding shape in the medical field can be adopted as appropriate.

  As shown in FIGS. 1 and 2A, the balloon cover 100 includes a distal end opening 113 connected to the distal end of the lumen 111 and a proximal end opening 115 connected to the proximal end of the lumen 111. It is constituted by a hollow tubular member.

  As shown in FIG. 2 (A), the lumen 111 of the balloon cover 100 is formed in a tapered shape in which the diameter gradually decreases from the proximal end opening 115 side toward the distal end opening 113 side.

  The diameter d1 of the portion (near the tip opening 113) where the diameter is the smallest in the lumen 111 can be formed, for example, in the range of 0.5 mm to 2.0 mm. In addition, the diameter d2 of the portion (near the proximal end opening 115) where the diameter is the largest in the lumen 111 can be formed to, for example, 0.6 mm to 5.0 mm.

  In a typical balloon catheter storage device, the balloon cover is fixed to the balloon by exerting a relatively large frictional force between the balloon and the balloon cover. For this reason, the lumen of the balloon cover is formed to have a diameter substantially similar to the outer diameter of the balloon in the folded state, and is identical over the axial direction in order to secure the fixing force for the balloon. It is formed to have a diameter. On the other hand, in the balloon cover 100 according to the present embodiment, as described later, it is not necessary to strictly set the magnitude of the frictional force to be applied between the balloon 410 and the balloon cover 100. The design freedom of the diameter dimension of the inner lumen 111 is high, and it is possible to form in various dimensions. In addition, since the design freedom of the shape (the cross-sectional shape and the like in the axial direction) of the lumen 111 of the balloon cover 100 is high, it is possible to adopt a tapered shape etc. as shown in FIG. Like the balloon cover 710 shown in the example, the shape of the proximal end (the end on which the proximal opening is formed) can be tapered (see FIG. 8).

  The length dimension (axial length) L1 of the balloon cover 100 can be formed to, for example, 30 to 230 mm. However, the length dimension L1 of the balloon cover 100 is not particularly limited as long as it can be accommodated so as to surround the folded balloon 410 in the axial direction, and the axial length dimension L3 of the balloon 410 is It can change suitably according to.

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

  Next, the stylet 10 provided in the balloon catheter storage device 200 will be described.

  As shown in FIGS. 1 and 2B, the stylet 10 has a curved portion 30 curved in a direction intersecting with an axis A along the longitudinal direction of the stylet 10, and a distal end side of the curved portion 30. The distal end side base portion 23 formed, the locking portion 40 formed on the distal end side of the distal end side base portion 23, and the proximal end side base portion 25 formed on the proximal end side of the curved portion 30 are provided.

  In the description of the stylet 10, the extension direction (longitudinal direction) of the distal side base 23 and the proximal side base 25 is referred to as the axial direction of the stylet 10, and the side on which the locking portion 40 is formed is referred to as the distal side. The side on which the proximal side base 25 is formed is referred to as a proximal side. The distal end means a predetermined range extending from the distal end to the proximal end, and the proximal end means a predetermined range extending from the proximal end to the distal end. Moreover, the X-axis attached | subjected to each figure shows the width direction of the stylet 10, and the Y-axis shows the axial direction of the stylet 10. As shown in FIG. The Z-axis is a direction orthogonal to a plane formed by the X-axis and the Y-axis, and indicates a direction in which the bending portion 30 spreads.

  As shown in FIG. 2 (B), the stylet 10 is made of one wire. The portion to which a predetermined shape is added to the wire constitutes the curved portion 30 and the locking portion 40. The portion where no shape is added to the wire, that is, the portion extending substantially linearly in the axial direction constitutes the distal end side base portion 23 and the proximal end side base portion 25.

  The curved portion 30 is constituted by a corrugated portion 31 shaped so as to be folded back in a direction intersecting with an axis A along the longitudinal direction of the stylet 10. In the illustrated example, five folded portions 31 a are formed by bending the wire so as to turn back five times, and the portion where the folded portions 31 a are formed is configured as the corrugated portion 31. In addition, in order to form the curved part 30, the frequency | count of bending | folding of a wire is not specifically limited, It is possible to make it increase / decrease suitably. Moreover, the wave shape formed at the time of folding is not limited to the shape gently curved in a convex shape outward with respect to the axis A as illustrated, for example, a linear shape (zigzag shape) And so on. Further, for example, the width dimension d3 of the folded portion 31a may be set to be different for each folded portion. Also, for example, the bending portion 30 may be configured to have a curved shape that spreads in the X-axis direction or a curved shape that spreads in both the Z-axis direction and the X-axis direction.

  As shown in FIG. 5, when using the balloon catheter storage device 200, the balloon cover 100 is disposed to cover (surround) the balloon 410 in a folded state. On the other hand, the stylet 10 is disposed such that the locking portion 40 is positioned on the distal end side of the opening edge 113a of the distal end opening 113 of the balloon cover 100, and the distal end side base portion 23, the bending portion 30, and the proximal end side base portion Each of the 25 is inserted into the guidewire lumen 431 of the inner tube shaft 430. Although not shown, the proximal end of the proximal base 25 is provided outside the guidewire lumen 431 via a proximal opening 435 communicating with the proximal end of the guidewire lumen 431 (see FIG. 3B). It is derived. The proximal end of the proximal end side base 25 of the stylet 10 does not lead out of the guidewire lumen 431 through the proximal end opening 432 communicating with the proximal end of the guidewire lumen 431. It may be located inside.

  The curved portion 30 of the stylet 10 has a frictional force by bringing the outer surface of each folded portion 31 a into contact with the inner surface of the inner tube shaft 430 in a state of being inserted into the guide wire lumen 431 formed in the inner tube shaft 430. To work. The stylet 10 is mechanically fixed to the inner tube shaft 430 of the balloon catheter 400 via this frictional force. Also, with the balloon cover 100 covering the balloon 410, a part of the inner surface 111a is brought into contact with the outer surface of the balloon 410, and this is better than the frictional force acting between the bending portion 30 and the inner tube shaft 430. A small frictional force is exerted on the outer surface of the balloon 410. Thereby, the balloon catheter 400 and the stylet 10 are fixed to each other, and the balloon cover 100 and the balloon 410 are fixed to each other, so that the balloon catheter 400, the balloon cover 100, and the stylet 10 are integrally assembled. It becomes.

  As described above, since the stylet 10 is fixed to the balloon catheter 400 with a relatively large frictional force acting between the bending portion 30 and the inner surface of the inner tube shaft 430, the balloon cover 100 and the balloon 410 Even if the frictional force acting between them, that is, the mechanical fixing force is set small, it is preferable to prevent relative displacement of the balloon cover 100 and the stylet 10 with respect to the balloon catheter 400. It is possible.

  As described above, the balloon 410 provided in the balloon catheter 400 used in a blood vessel running in the lower limb has a relatively long balloon length. Therefore, when the balloon 410 is pulled out of the balloon cover 100, an excessive tensile force may be applied to the balloon catheter 400, which may cause the shaft 420 of the balloon catheter 400 to be stretched. On the other hand, in the balloon cover 100 and the stylet 10 according to the present embodiment, the friction force acting between the balloon cover 100 and the balloon 410 can be set relatively small, so the balloon length Even when used for the balloon 410 formed to be long, it is possible to preferably prevent the occurrence of problems such as the shaft 420 of the balloon catheter 400 being stretched.

  In the state where the balloon 410 is inserted into the balloon cover 100, the portion to which the frictional force is applied between the balloon 410 and the balloon cover 100 may be appropriately set in a range in which a desired frictional force can be obtained. Although it is possible, for example, when the lumen 111 of the balloon cover 100 has a tapered shape as in the present embodiment, as shown in FIG. 5, the portion near the tip of the balloon 410 is the inner surface 111 a of the balloon cover 100. It is possible to make it contact with and to make it act on frictional force.

  However, when the balloon 410 is inserted into the balloon cover 100, the stylet 10, the balloon cover 100, and the balloon catheter 400 can be assembled without applying a frictional force between the balloon 410 and the balloon cover 100. May be

  As shown in FIG. 2A, the lumen 111 of the balloon cover 100 has a tapered shape in which the diameter decreases from the proximal end opening 115 side toward the distal end opening 113 side. Therefore, the operation of inserting the balloon 410 into the balloon cover 100 and the operation of pulling the balloon 410 out of the balloon cover 100 can be smoothly performed.

  As shown in FIGS. 2B and 5, the locking portion 40 has a ring shape having an outer diameter larger than the diameter (inner diameter) of the distal end opening 113 of the balloon cover 100. The locking portion 40 disengages the balloon cover 100 from the balloon 410 when the balloon cover 100 moves to the distal end side of the stylet 10 with the balloon catheter 400, the balloon cover 100 and the stylet 10 assembled. Have a function to prevent

  A force directed to move the balloon cover 100 toward the distal end side is applied, and when the balloon cover 100 is moved, the opening edge 113 a of the balloon cover 100 abuts on the locking portion 40. This prevents movement of the balloon cover 100 toward the distal end. In this embodiment, since the curved portion 30 of the stylet 10 is structured to fix the inner tube shaft 430 by applying a relatively large frictional force, the balloon cover 100 moves to the distal end side. Even if the locking portion 40 is hit, it is possible to prevent the movement of the locking portion 40, that is, the stylet 10 itself.

  As shown in FIG. 2B, the locking portion 40 has a shape that is curved in a substantially circular shape toward the tip end side. For this reason, when the medical worker etc. handle the stylet 10, it is possible to prevent the tip of the stylet 10 from hitting or being caught by a finger or a glove worn on the hand. In addition, since the locking portion 40 has a ring shape, an operation of inserting the stylet 10 into the inner tube shaft 430 while holding a finger or the like in the hollow space portion 41 and holding it, or the stylet 10 Can be taken out of the inner pipe shaft 430. This makes it possible to perform each operation quickly and smoothly.

  As shown in FIG. 5, when the curved portion 30 of the stylet 10 is inserted through the guide wire lumen 431 of the inner tube shaft 430, the position closer to the proximal end than the proximal end 415 of the balloon 410 (outer tube shaft It is arrange | positioned so that the inner surface of the inner tube shaft 430 may be contacted in the position which overlaps in the axial direction with the position where 440 is arrange | positioned.

  When the bending portion 30 is disposed at a position overlapping the position where the balloon 410 is formed in the axial direction, the bending portion 30 tends to expand radially outward in the inner pipe shaft 430. The pressing force acting at this time may expand the profile (shape in a folded state) of the balloon 410 in a state of being wound and folded around the inner tube shaft 430. When the profile of the balloon 410 is expanded, the outer surface of the balloon 410 is pressed against the inner surface 111 a of the balloon cover 100, and the frictional force acting between the balloon 410 and the balloon cover 100 becomes unnecessarily large. As a result, when the balloon 410 is removed from the balloon cover 100 or the like, there may occur a problem such as the shaft 420 of the balloon catheter 400 being stretched. In the present embodiment, by arranging the curved portion 30 of the stylet 10 in a position not overlapping the position where the balloon 410 is arranged in the axial direction, it is possible to prevent the occurrence of the above problems. .

  When fixing the stylet 10 to the balloon catheter 400, an operation of pushing the curved portion 30 of the stylet 10 into the guide wire lumen 431 of the inner tube shaft 430 is performed. When pressed into the guide wire lumen 431 of the inner tube shaft 430, the curved portion 30 formed in a wave shape deforms into an axially elongated flat shape so as to follow the inner surface of the inner tube shaft 430 ( The deformation | transformation shown with a dashed-two dotted line in FIG. For this reason, the insertion work by pushing can be performed smoothly. Also, for example, in the case where the dimension d3 (see FIG. 2B) of the curved portion 30 in the width direction in the unused state is formed larger than the diameter of the guide wire lumen 431 of the inner tube shaft 430 Also, by performing the operation of pushing the stylet 10, it is possible to arrange the bending portion 30 at a desired position in the guidewire lumen 431. Even when the stylet 10 is pulled out from the guide wire lumen 431 of the inner tube shaft 430, the bending portion 30 is deformed by performing an operation of pulling the locking portion 40 of the stylet 10 with a finger or the like. Since the tip end side of the inner pipe shaft 430 can be moved, the operation can be performed easily and quickly.

  The wire forming the stylet 10 can be made of, for example, a known resin material or metal material having elasticity. When the wire is made of an elastic material, the bending portion 30 can be easily deformed when the stylet 10 is moved in and out of the guide wire lumen 431 of the inner tube shaft 430. It becomes possible to carry out the work of pulling out more smoothly.

  Examples of materials constituting the wire include thermoplastic resins such as vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), and styrene-ethylene-propylene-styrene copolymer (SEPS) Thermoplastic resin such as elastomer, nylon, PET, etc., rubber, thermosetting resin such as silicone elastomer, metal materials such as SUS wire, copper wire, titanium wire, nitinol wire, etc., and a combination of the above-mentioned respective materials, etc. are used It is possible.

  Referring to FIG. 2B, the length dimension (total length in the axial direction) L2 of the stylet 10 can be, for example, 100 to 500 mm, and the length dimension L21 of the locking portion 40 is, for example, The length dimension L22 of the distal end side base 23 may be, for example, 30 to 210 mm, and the length dimension L23 of the bending portion 30 may be, for example, For example, it can be formed in 10-250 mm, and the length dimension L24 of the proximal side base 25 can be formed in 10-460 mm, for example. Moreover, the width dimension d3 of the folding | returning part 31a can be formed in 0.4-1.0 mm, for example. However, the dimensions of each part of the stylet 10 can be appropriately changed according to the specifications (dimensions and the like) of the balloon catheter 400 and the balloon cover 100, and the dimensions are not limited to the above-described example of dimensions.

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

  FIG. 4 illustrates the balloon catheter assembly 500 as it is stored and distributed.

  The balloon catheter assembly 500 can be contained in a packaging container 510 called a peel bag when transported and stored after manufacture. In addition, the long shaft 420 of the balloon catheter 400 is accommodated in a predetermined tubular member called a holder tube 520 having a lumen 521, in consideration of the handling during transportation or storage. (See Figure 5). 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 the balloon catheter 400, in this unused state, as shown in FIG. 5, the balloon 410 is covered and protected by the balloon cover 100. This makes it possible to prevent the balloon 410 from being damaged by rubbing against the inner surface of the holder tube 520 or the like. FIG. 5 is a cross-sectional view showing the inside of the portion 5A shown in FIG. 4 in an enlarged manner.

  As shown in FIG. 4, the holder tube 520 includes a plurality of fasteners 523 for maintaining the holder tube 520 in a wound state, and a hub fastener 525 for securing the hub 450 of the balloon catheter 400. , Is equipped.

  When storing the balloon catheter 400 in the holder tube 520, first, the balloon 410 is inserted into the balloon cover 100. Next, the stylet 10 is inserted into the inner tube shaft 430 of the balloon catheter 400 by sequentially inserting the proximal side base 25, the bending portion 30 and the distal side base 23 of the stylet 10 into the guide wire lumen 431 of the balloon catheter 400. Fix against. Thus, after the balloon catheter 400, the balloon cover 100, and the stylet 10 are assembled to each other, 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. Then, with the balloon 410 in a folded state protected by the balloon cover 100 and the stylet 10, the balloon catheter assembly 500 is housed and packaged in the packaging container 510. Thereafter, in a state where the balloon catheter assembly 500 is housed and packaged in the packaging container 510, the balloon catheter assembly 500 is sterilized. The balloon catheter assembly 500 can be provided to a medical facility, a medical site, etc. in a packaged state as described above.

  As described above, according to the balloon catheter assembly 500 according to the present embodiment, the stylet 10 and the balloon are generated by the frictional force acting between the bending portion 30 formed on the stylet 10 and the inner tube shaft 430 of the balloon catheter 400. It is possible to maintain the relative positional relationship of the catheter 400. The movement of the balloon cover 100 in the axial direction is restricted by the locking portion 40 formed on the stylet 10. Thus, the balloon catheter assembly 500 according to the present embodiment can maintain the relative positional relationship between the balloon cover 100 and the balloon catheter 400. Therefore, the design dimension of the lumen 111 of the balloon cover 100 can have a certain width (margin), and one type of balloon cover 100 can correspond to a plurality of types of balloons 410 of different types. . As a result, it is possible to suppress complication of the work of attaching to the balloon, and it is possible to suppress an increase in cost required for production and maintenance of a plurality of types of balloon covers. Therefore, the balloon catheter storage instrument 200 is excellent in economics and can be quickly and easily attached to the balloon 410, and the balloon catheter storage instrument 200 stores the information. It becomes possible to provide a balloon catheter assembly 500 comprising the balloon catheter 400.

  In addition, since the bending portion 30 is configured to contact the inner surface of the inner pipe shaft 430 at a position proximal to the proximal end 415 of the balloon 410, it is wound around the inner pipe shaft 430 and folded. The profile of the balloon 410 can be prevented from spreading, and the frictional force acting between the balloon 410 and the balloon cover 100 can be prevented from becoming unnecessarily large.

  In addition, since the curved portion 30 has the corrugated portion 31 shaped so as to be folded back in the direction intersecting with the axis line A along the longitudinal direction of the stylet 10, the guide wire lumen 431 of the inner tube shaft 430 By pushing the stylet 10 inward, the bending portion 30 can be easily disposed at a desired position of the guidewire lumen 431.

  Also, with the balloon 410 inserted into the balloon cover 100 and the stylet 10 inserted into the guide wire lumen 431, the balloon cover 100 is curved by bringing the inner surface into contact with at least a part of the outer surface of the balloon 410. Because the frictional force smaller than the frictional force acting on the inner surface of the inner tube shaft 430 is applied to the balloon 410, the balloon catheter 100 can be operated by pulling the balloon 410 out of the balloon cover 100. It becomes possible to prevent the shaft 420 of the balloon catheter 400 from being stretched due to an unnecessary load on the 400.

  In addition, since the locking portion 40 has an outer diameter larger than the inner diameter d1 of the distal end opening 113 of the balloon cover 100, the balloon cover 100 is given a force in the direction of moving it toward the distal end. When the cover 100 moves, the opening edge 113a of the balloon cover 100 abuts on the locking portion 40, so that the movement of the balloon cover 100 toward the distal end can be suitably blocked.

  Next, a modification is described. In the description of each modification, the description of the same members as the members already described and the points that can be configured in the same manner and the like will be omitted as appropriate.

  FIG. 6 shows a balloon catheter storage device 210 according to a modification.

  In the balloon catheter storage device 210, the locking portion 40 of the stylet 10 is fixed (fixed) to the balloon cover 100. By this configuration, since the balloon cover 100 and the stylet 10 are more reliably positioned relative to each other, the balloon cover 100 is displaced during use of the balloon catheter storage device 210. It is possible to prevent the problem more appropriately.

  Although the position which fixes the balloon cover 100 and the stylet 10 is not specifically limited, For example, when the ring-shaped latching | locking part 40 is provided in the stylet 10, the inner surface located in the tip opening 113 vicinity of the balloon cover 100 A part of the locking portion 40 can be fixed to the Further, the fixing method is not particularly limited, but, for example, in consideration of the materials of the balloon cover 100 and the stylet 10, a known fixing method by fusion, an adhesive or the like can be adopted.

  FIG. 7 shows a balloon catheter assembly 600 according to a modification.

  In the balloon assembly 600 according to the present modification, the curved portion 60 formed in the stylet 10 is formed by the spiral shaped portion 61 which is helically shaped in the circumferential direction of the axis A along the longitudinal direction of the stylet 10. It is configured.

  Even when the curved portion 60 is formed in such a helical shape, the outer tube of the inner pipe shaft 430 is deformed while appropriately changing the outer shape of the curved portion 60 as in the case of the curved portion 30 formed in the wave shape described above. Since the insertion into the guide wire lumen 431 and the withdrawal of the inner tube shaft 430 from the guide wire lumen 431 can be performed, the above-described operations can be performed easily and quickly.

  The axial length of the helical portion 61 and the degree of coarseness (interval) in the axial direction are not particularly limited, and may be changed as appropriate.

  FIG. 8 shows a modification of the balloon cover. As shown in the modification, the balloon cover 710 has, for example, a proximal end 715a positioned on the insertion direction side where the balloon 410 is inserted into a tapered shape in which the inner diameter gradually increases toward the proximal opening 715. It is possible to form.

  Since the balloon cover 710 includes the tapered proximal end 715a as shown, the operation of inserting the balloon 410 into the balloon cover 710 and the balloon 410 from the inside of the balloon cover 710 as with the balloon cover 100 described above. It becomes possible to do the work of pulling out smoothly. The shape of the lumen 711 of the balloon cover 710 can be formed in a straight shape extending substantially linearly toward the distal end side of the proximal end portion 715a. By forming the lumen 711 in such a shape, it is possible to relatively easily manufacture the balloon cover 710 by molding.

  As a dimension example of each part of the balloon cover 710, the total length L4 can be formed to, for example, 100 to 500 mm, and the diameter d4 of the tip end opening 713 can be formed to, for example, 0.9 to 2.0 mm. The diameter d5 of the proximal end opening 715 can be, for example, 1.5 to 3.0 mm, and the length dimension L4 of the portion having a tapered shape at the proximal end 715a is, for example, 1.5 to The thickness t of the tube wall can be, for example, 0.2 to 0.5 mm.

  A tapered shape is added to both the distal end portion and the proximal end portion of the balloon cover 710 so that each of the distal end opening 713 and the proximal end opening 715 can be used as an insertion port for inserting the balloon 410. It is also possible. With such a configuration, the convenience of the balloon cover 710 can be further improved.

  Although the balloon catheter assembly according to the present invention has been described above through the embodiment and the plurality of modifications, the present invention is not limited to only the configuration described in the embodiment and each modification, and the scope of the claims It is possible to change suitably based on a statement.

  For example, one stylet can be provided with corrugations and spirals. Also, for example, in the description of the embodiment, an example is shown in which the bending portion is disposed to be located on the proximal side of the position where the balloon is disposed, but the bending portion is any of the inner surfaces of the inner pipe shaft It is sufficient if it is possible to contact a portion of such to apply a frictional force, and the installation position and the like can be changed appropriately. Also, for example, in the description of the embodiment, a balloon cover including a tapered shaped lumen whose diameter decreases toward the distal end side is shown, but the shape of the lumen of the balloon cover is as long as the balloon can be accommodated. It is possible to change suitably.

10 stylet,
23 tip side base,
25 proximal base,
30, 60 bends,
31 wave-shaped parts,
40 locking parts,
61 spirals,
100 balloon covers,
111 lumens,
111a inside,
113 tip opening,
113a opening edge,
115 proximal opening,
200, 210 balloon catheter storage devices,
400 balloon catheters,
410 balloons,
416 pressure part,
420 shaft,
430 inner tube shaft,
431 guidewire lumen,
440 outer tube shaft,
450 hubs,
500, 600 balloon catheter assembly,
510 packaging containers,
520 holder tube,
710 balloon cover,
713 Tip opening,
715 proximal opening,
715a proximal end.

Claims (6)

An inner tube shaft including a guide wire lumen through which a guide wire can be inserted, an outer tube shaft forming a pressurized medium lumen through which a pressurized medium can flow between the inner tube shaft, and a tip portion of the inner tube shaft A balloon catheter having a proximal end connected to the outer tube shaft and a balloon expandable and contractible by the inflow and outflow of the pressurized medium;
A balloon catheter storage device including a balloon cover formed with a lumen into which the balloon is inserted and housing the balloon in a folded state, and a stylet inserted through the guide wire lumen;
The stylet is
A locking portion for restricting the movement of the balloon cover, and a curving in a direction intersecting with an axis along the longitudinal direction of the stylet, and in a state of being inserted into the guide wire lumen, on the inner surface of the inner tube shaft contact with the action of frictional forces have a curved portion,
The balloon catheter assembly according to claim 1, wherein the curved portion contacts the inner surface of the inner tube shaft at a position proximal to the proximal end of the balloon. The curved portion is a spiral in the circumferential direction of the wave-shaped portion shaped to be folded back in a direction crossing the axis along the longitudinal direction of the stylet and / or the axis along the longitudinal direction of the stylet The balloon catheter assembly according to claim 1, wherein the balloon catheter assembly has a helically shaped portion. The balloon catheter assembly according to claim 1, wherein the proximal end of the balloon cover has a tapered shape in which the inner diameter gradually increases toward the proximal opening. When the balloon is inserted into the balloon cover and the stylet is inserted into the guide wire lumen, the balloon cover contacts the inner surface with at least a part of the outer surface of the balloon to form the curved portion. The balloon catheter assembly according to any one of claims 1 to 3 , wherein the balloon exerts a smaller frictional force on the balloon than the frictional force exerted on the inner surface of the inner tube shaft. The balloon catheter assembly according to any one of claims 1 to 4 , wherein the locking portion and the balloon cover are fixed. The locking portion has a larger outer diameter than the inner diameter of the above end opening of the balloon cover, a balloon catheter assembly according to any one of claims 1-4.