JP2021146135A - Balloon protector - Google Patents

Abstract

To provide a balloon protector capable of suppressing the generation of a bending habit of a balloon, facilitating the arrangement of the balloon at the center of a living lumen, and suppressing the reduction in the insertion performance and push-in property of the balloon in the living lumen.SOLUTION: A balloon protector 10 for protecting a balloon 70 of a balloon catheter 40 has a cover part 14 formed in a tubular shape with a first opening 12 and a second opening 13 by winding a wire 11, and a linear part 15 formed of the same wire 11 as the wire 11 and extending from the first opening 12 of the cover part 14 to project toward the second opening 13.SELECTED DRAWING: Figure 1

Description

The present invention relates to a balloon protector for accommodating and protecting a balloon.

In recent years, balloon catheters have been used to improve lesions (stenosis) that occur in the lumen of a living body. A balloon catheter usually includes a long shaft portion and a balloon provided on the tip side of the shaft portion and expands in the radial direction, and a contracted balloon is passed through a narrow biological lumen to a target in the body. The lesion can be expanded by expanding it after reaching the location.

The balloon before use is usually covered with a resin circular tubular protective tube (see, for example, Patent Document 1). The protective tube keeps the balloon in a contracted state while suppressing the drug from falling off the surface of the balloon.

JP 2001-079093

Protective tubes made of resin tend to bend during sterilization performed during packaging. When the protective tube has a bending habit, the balloon also has a bending habit. When the balloon is bent, when the balloon is bent, the balloon tends to bend when the balloon is pushed in, and the pushability is lowered. Further, it becomes difficult to arrange the balloon in the center of the biological lumen such as a blood vessel at the time of treatment. In addition, the balloon is more likely to be caught in the lumen of the living body during treatment, which reduces the insertability.

The present invention has been made to solve the above-mentioned problems, suppresses the occurrence of bending habits in the balloon, facilitates the placement of the balloon in the center of the living lumen, and makes it easier for the balloon to be placed in the living lumen. It is an object of the present invention to provide a balloon protector capable of suppressing a decrease in insertability and pushability.

The balloon protector that achieves the above object is a balloon protector for protecting the balloon of the balloon catheter, and is a tubular cover formed by winding a wire rod and having a first opening and a second opening. It is characterized by having a portion and a linear portion formed of the same wire rod as the wire rod and extending from the first opening of the cover portion and projecting toward the second opening.

In the balloon protector configured as described above, the cover portion covers and protects the balloon, and the linear portion is inserted into the lumen of the shaft portion penetrating the balloon of the balloon catheter, so that the cover portion covers the balloon. The condition can be maintained in good condition. Since the cover portion is a wire rod wound in a tubular shape, it is resistant to bending and can prevent the balloon from becoming bent. Therefore, the balloon protector can facilitate the placement of the balloon in the center of the living lumen, and can suppress the deterioration of the insertability and the pushing property of the balloon in the living lumen.

The wire rod located in the cover portion is tightly wound, and the cover portion may be bent by elastic deformation. As a result, even if the cover portion is elastically deformed and bent so as to form a gap between adjacent wires, the cover portion can return to a tightly wound state so as to eliminate the gap due to its own restoring force. Therefore, the cover portion is hard to bend, and even if it bends, it can easily return to the original shape, so that it is possible to effectively suppress the balloon from becoming bent.

The cover portion may have a reduced diameter portion having an inner diameter that decreases toward the first opening on the side of the first opening. As a result, the reduced diameter portion of the cover portion is likely to fit into the shape of the tip portion of the balloon catheter that is reduced in diameter toward the tip end. Therefore, the cover portion is less likely to be displaced from the balloon catheter, and the balloon can be stably protected.

The cover portion may have at least one convex portion protruding toward the center of the winding. As a result, the convex portion can enter the concave portion formed on the surface of the folded balloon. Therefore, the cover portion can have a shape that follows the shape of the balloon. Therefore, the cover portion can satisfactorily hold the folded shape of the balloon. In addition, the cover portion is less likely to come off the balloon, and the balloon can be stably protected.

It is a figure which shows the balloon catheter which contained the balloon in the balloon protective equipment which concerns on this embodiment, (A) is a plan view, (B) is a sectional view. It is a top view which shows the balloon catheter housed in a holder tube. It is a figure which shows the balloon protective equipment which concerns on this embodiment, (A) is a plan view, (B) is a front view seen from the tip side. It is a top view which shows the bent state of the balloon housed in a balloon protector. It is a top view which shows the 1st modification of a balloon protector. It is sectional drawing which shows the 2nd modification of a balloon protector. It is a cross-sectional view which shows the 3rd modification of a balloon protector, (A) is a plan view, (B) is a cross-sectional view along the line AA of (A).

Hereinafter, embodiments of the present invention will be described with reference to the drawings. The dimensions of the drawings may be exaggerated and differ from the actual dimensions for convenience of explanation. Further, in the present specification and the drawings, components having substantially the same functional configuration are designated by the same reference numerals, so that duplicate description will be omitted. In the present specification, the side of the balloon catheter to be inserted into the blood vessel is referred to as the "tip side", and the side to be operated is referred to as the "base end side".

As shown in FIG. 1, the balloon protector 10 according to the present embodiment is a device that covers the balloon 70 of the balloon catheter 40 and protects the balloon 70 before being used for treatment from deformation or damage. As shown in FIG. 2, the balloon protector 10 is housed in the holder tube 30 together with the balloon catheter 40, and is stored and transported. The balloon protector 10 is removed from the balloon 70 before using the balloon catheter 40.

First, the balloon catheter 40 housed in the balloon protector 10 and the holder tube 30 will be described. As shown in FIG. 1, the balloon catheter 40 has a long shaft portion 50, a hub 60 fixed to the base end of the shaft portion 50, and a balloon 70 provided at the tip end portion of the shaft portion 50. ing.

The shaft portion 50 includes an outer pipe 51 and an inner pipe 52 arranged inside the outer pipe 51. An expansion lumen 53 through which an expansion fluid for expanding the balloon 70 flows is formed between the outer tube 51 and the inner tube 52. A guide wire lumen 54 into which a guide wire can be inserted is formed inside the inner pipe 52.

The hub 60 includes a first hub opening 61 that communicates with the expansion lumen 53 of the outer pipe 51 and functions as a port for inflowing and discharging the expansion fluid, and a second hub opening 62 that communicates with the guide wire lumen 54. ing. When the expansion fluid flows in from the first hub opening 61, the expansion fluid flows into the inside of the balloon 70 via the expansion lumen 53. As a result, the balloon 70 expands outward in the radial direction.

The balloon 70 is a portion that expands the narrowed portion or the like by expanding. The outer surface of the balloon 70 may be coated with a drug layer 71 for suppressing stenosis. Alternatively, a stent that is plastically deformed by the expansion of the balloon 70 and placed in the narrowed portion may be placed on the outer surface of the balloon 70. The tip end side of the balloon 70 is joined to the outer wall surface of the inner pipe 52 in a state of maintaining liquidtightness. The base end side of the balloon 70 is joined to the outer wall surface of the tip end portion of the outer tube 51 in a state of maintaining liquidtightness. Therefore, the inside of the balloon 70 communicates with the expansion lumen 53, and the expansion fluid can flow in from the proximal end side through the expansion lumen 53. The balloon 70 expands by the inflow of the expansion fluid, and contracts by discharging the inflowing expansion fluid.

The inner pipe 52 and the outer pipe 51 preferably have a structure having appropriate flexibility and appropriate rigidity. The constituent materials of the inner tube 52 and the outer tube 51 are, for example, a polymer material such as polyethylene, polypropylene, polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or the above two types. These are multilayer tubes made of the above-mentioned polymer materials.

The constituent material of the balloon 70 is preferably flexible to some extent, for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof. Such as polyolefin, soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesin and other thermoplastic resins, silicone rubber, latex rubber and the like.

The balloon catheter 40 described above is a so-called over-the-wire type in which an opening on the proximal end side of the guide wire lumen 54 is formed in the hub 60. However, the balloon catheter 40 may be a so-called rapid exchange type in which an opening on the proximal end side of the guide wire lumen 54 is formed in the shaft portion 50.

Next, the holder tube 30 will be described. As shown in FIG. 2, the holder tube 30 holds the shape of the tubular accommodating portion 31 that internally accommodates the balloon catheter 40, the connecting portion 32 that can connect the base end portion of the balloon catheter 40, and the accommodating portion 31. The holding portion 33 is provided.

The accommodating portion 31 is a wound tube. The accommodating portion 31 accommodates the balloon catheter 40 so that it can be pulled out. The holding portion 33 is a member that connects adjacent portions by being wound around the accommodating portion 31.

The connecting portion 32 is a straight tube, and the accommodating portion 31 is inserted and connected to one end side, and the balloon catheter 40 can be inserted into the other end side. The balloon catheter 40 can be connected by fitting the hub 60 of the inserted balloon catheter 40 to the other end side of the connecting portion 32. The connecting portion 32 may be formed integrally with the accommodating portion 31. The portion of the accommodating portion 31 in which the balloon 70 and the balloon protector 10 are accommodated is formed linearly, but at least a part thereof may be curved.

The constituent materials of the accommodating portion 31, the connecting portion 32, and the holding portion 33 are not particularly limited, and are, for example, polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, polyvinyl chloride, and polystyrene. , Polyamide, polyimide, etc.

Next, the balloon protective device 10 will be described. As shown in FIGS. 1 and 3, the balloon protector 10 is formed of a single wire rod 11. The balloon protector 10 extends from a tubular cover portion 14 having a first opening 12 and a second opening 13 by winding a wire rod 11 and a first opening 12 of the cover portion 14. It is provided with a linear portion 15 to be formed.

The cover portion 14 is formed in a substantially circular tubular shape by spirally winding the wire rod 11. The circular tubular cover portion 14 is opened by the first opening 12 and the second opening 13. The wire rods 11 forming the cover portion 14 are wound in a circular tubular shape so as to be adjacent to each other side by side along the axis X of the circular tube. The axis X of the circular tube is preferably linear, but may be slightly curved. Adjacent parts of the wire rod 11 come into contact with each other. That is, the wire rod 11 is tightly wound around the cover portion 14. It should be noted that the adjacent portions of the wire rods 11 forming the cover portion 14 do not have to come into contact with each other. Therefore, the wire rod 11 may be loosely wound with adjacent portions separated from each other. Further, a part of the wire rod 11 forming the cover portion 14 may be tightly wound, and the other portion may be loosely wound.

The linear portion 15 extends from the first opening 12 of the cover portion 14 and curves, and the linear portion 15 extends from the first opening 12 to the second opening 13 along the axial center X of the circular pipe. It is provided with a support portion 17 that projects toward it. The connecting portion 16 extends from the tip of the cover portion 14 and gradually changes its direction, and is curved until it faces the proximal end direction on the extension line of the axis X. The shape of the connecting portion 16 is not limited as long as the cover portion 14 and the supporting portion 17 can be connected, and may not be curved, for example.

The support portion 17 is a portion that is inserted into the guide wire lumen 54 of the shaft portion 50 from the tip side and is supported by the shaft portion 50. The support portion 17 projects from the connecting portion 16 along the axial center X in the proximal direction. The support portion 17 is preferably located on the axis X, but may deviate from the axis X. The support portion 17 preferably extends linearly from the connection portion 16 in the proximal direction, but may be curved. The support portion 17 enters the inside of the cover portion 14 from the first opening portion 12 and extends from the second opening portion 13 to the proximal end side. This makes it easier to insert the support portion 17 into the guide wire lumen 54 of the shaft portion 50. The base end portion of the support portion 17 may be arranged inside the cover portion 14 or may be arranged at a position corresponding to the second opening portion 13.

The wire diameter of the wire rod 11 is not particularly limited, but is preferably smaller than the inner diameter of the guide wire lumen 54 so that it can be inserted into the guide wire lumen 54 of the shaft portion 50.

The cover portion 14 and the linear portion 15 are preferably elastically deformable. As a result, the cover portion 14 and the linear portion 15 can return to their original shapes even if they are deformed by receiving a force. The cover portion 14 and the linear portion 15 may be plastically deformable.

The constituent material of the wire 11 is not particularly limited, but is, for example, stainless steel, Ni—Ti alloy, tungsten, cemented carbide and the like. Further, the wire rod 11 may be formed by annealing any of these metal materials to memorize the shape. The surface of the wire rod 11 may be coated with a low friction material that reduces frictional resistance. Examples of the low friction material include a fluororesin material such as polytetrafluoroethylene (PTFE). The low friction material may be coated only on a part of the wire rod 11. For example, the low friction material may be coated only on the inner peripheral surface of the cover portion 14 that comes into contact with the balloon 70.

Next, the action and effect of the balloon protective device 10 according to the present embodiment will be described.

When protecting the balloon 70 with the balloon protector 10, as shown in FIG. 1, the base end of the support portion 17 of the linear portion 15 is inserted into the guide wire lumen 54 of the shaft portion 50, and the balloon is provided with the cover portion 14. Cover 70. As a result, the support portion 17 is inserted into the guide wire lumen 54, so that the cover portion 14 can maintain a good position with respect to the balloon 70. Since the cover portion 14 has a spiral shape, it is difficult to bend. Therefore, the cover portion 14 can prevent the balloon 70 from becoming bent. In addition, the cover portion 14 can prevent the drug layer 71 on the surface of the balloon 70 from peeling off. Further, as shown in FIG. 4, even if the balloon protector 10 and the balloon 70 are stored for a short time or a long time in a bent state, the cover portion 14 and the linear portion 15 that can be elastically deformed are formed. By being released from the load, it is possible to return to the original shape before bending (see FIGS. 1 and 3). Then, the cover portion 14 and the linear portion 15 that return to the original straight shape can straighten the holding balloon 70 and the shaft portion 50 into a straight shape. Since the original shape of the cover portion 14 is a shape in which the wire rod 11 is tightly wound, it can be surely returned to the original shape.

Alternatively, even if the balloon 70 is placed on the curved portion of the holder tube 30, the balloon protector 10 tries to return to the original straight shape in the gap between the balloon protector 10 and the lumen of the holder tube 30, so that the balloon 70 The balloon 70 becomes straight while suppressing bending habits.

When using the balloon catheter 40, the operator pulls out the balloon catheter 40 covered with the balloon protective device 10 from the holder tube 30. At this time, the balloon 70 and the balloon protector 10 pass through the wound portion of the holder tube 30. However, the balloon 70 is protected by the balloon protector 10. Therefore, it is possible to prevent the drug layer 71 from peeling off from the balloon 70. Also, the balloon 70 may be bent as it passes through the wound portion of the holder tube 30. However, since the balloon 70 is covered with the balloon protective device 10, it is difficult to bend. Even if the balloon 70 is bent, the balloon protector 10 that bends together with the balloon 70 can elastically return to its original shape. Therefore, when the balloon 70 is pulled out from the holder tube 30, it can return to its original linear shape.

After pulling out the balloon catheter 40 from the holder tube 30, the operator moves the balloon protector 10 toward the tip of the balloon catheter 40. As a result, the support portion 17 is pulled out from the guide wire lumen 54, and the cover portion 14 is removed from the balloon 70. The balloon 70 protected by the balloon protector 10 and the inner tube 52 inside the balloon 70 are straight because they have almost no bending habit. Therefore, the balloon 70 inserted into the biological lumen such as a blood vessel can be easily arranged at the center of the biological lumen, and the operability of the balloon catheter 40 is improved. Further, since the balloon 70 and the inner tube 52 inside the balloon 70 are straight, the balloon 70 is less likely to be caught in the lumen of the living body during the procedure. Therefore, the insertability of the balloon catheter 40 is improved, and the peeling of the drug layer 71 on the surface of the balloon 70 can be suppressed. Further, since the balloon 70 and the inner tube 52 inside the balloon 70 are straight, the inner tube 52 inside the balloon 70 and the balloon 70 is less likely to bend when the balloon 70 is pushed in. Therefore, the pushability of the balloon catheter 40 is improved.

As described above, the balloon protector 10 according to the present embodiment is the balloon protector 10 for protecting the balloon 70 of the balloon catheter 40, and the wire rod 11 is wound around the first opening 12 and the second opening 12. The cover portion 14 formed in a tubular shape having the opening portion 13 of the above, and the wire rod portion 11 which is the same as the wire rod portion 11, extends from the first opening portion 12 of the cover portion 14 toward the second opening portion 13. It has a protruding linear portion 15.

The balloon protector 10 configured as described above covers and protects the balloon 70 with the cover portion 14, and inserts the linear portion 15 into the lumen of the shaft portion 50 penetrating the balloon 70 of the balloon catheter 40. The state in which the cover portion 14 covers the balloon 70 can be maintained satisfactorily. Since the cover portion 14 is a wire rod 11 wound in a tubular shape, it is resistant to bending and can prevent the balloon 70 from becoming bent. Therefore, the balloon protective device 10 can facilitate the placement of the balloon 70 in the center of the living lumen, and can suppress the deterioration of the insertability and the pushing property of the balloon 70 in the living lumen.

Further, the wire rod 11 located in the cover portion 14 is tightly wound, and the cover portion 14 can be bent by elastic deformation. As a result, even if the cover portion 14 is elastically deformed and bent so as to form a gap between adjacent wire rods 11, the cover portion 14 can return to a tightly wound state so as to eliminate the gap due to its own restoring force. .. Therefore, the cover portion 14 is hard to bend and can easily return to the original shape even if it bends, so that it is possible to effectively suppress the balloon 70 from having a bending habit. Therefore, for example, even if the balloon 70 and the cover portion 14 are stored for a long period of time in a bent state under a load, they can be easily returned to their original shape with less bending by being released from the load.

The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, not only the balloon 70 but also the shaft portion 50, the outer pipe 51 or the inner pipe 52 may be linear.

Further, as in the first modification shown in FIG. 5, the cover portion 14 has a reduced diameter portion 18 having an inner diameter decreasing toward the first opening 12 on the first opening 12 side. You may. As a result, the reduced diameter portion 18 of the cover portion 14 can easily fit into the shape of the tip portion of the balloon catheter 40 whose diameter is reduced toward the tip end. Therefore, the cover portion 14 is less likely to be displaced from the balloon catheter 40, and the balloon 70 can be stably protected.

Further, as in the second modification shown in FIG. 6, for example, a flexible circular tubular protective tube 19 made of resin may be arranged between the cover portion 14 and the balloon 70. Thereby, the peeling of the drug layer 71 from the balloon 70 can be effectively suppressed.

Further, as in the third modification shown in FIG. 7, the cover portion 14 may have at least one convex portion 20 projecting toward the center of the winding. In the example shown in FIG. 7, four convex portions 20 are formed in the circumferential direction at each portion of the wire rod 11 forming the cover portion 14 that is adjacent to each other in the direction along the axis X. Each of the convex portions 20 can enter the concave portion between the plurality of blade portions 72 formed in the balloon 70 folded on the outer peripheral surface of the inner pipe 52. Therefore, the cover portion 14 can have a shape that follows the shape of the balloon 70. Therefore, the cover portion 14 can satisfactorily hold the folded shape of the balloon 70. Further, the cover portion 14 is less likely to be displaced from the balloon 70, and the balloon 70 can be stably protected.

10 Balloon protector 11 Wire 12 1st opening 13 2nd opening 14 Cover 15 Linear 16 Connection 17 Support 20 Convex 40 Balloon catheter 50 Shaft 51 Outer tube 52 Inner tube 53 Expansion lumen 54 Guide wire lumen 70 Balloon 71 Drug layer 72 Blade

Claims (4)

A balloon protector for protecting the balloon of a balloon catheter.
A tubular cover portion having a first opening and a second opening by winding a wire rod, and a cover portion formed in a tubular shape.
A balloon protector characterized by having a linear portion formed of the same wire as the wire, extending from the first opening of the cover portion and projecting toward the second opening. The balloon protective device according to claim 1, wherein the wire rod located in the cover portion is tightly wound, and the cover portion can be bent by elastic deformation. The balloon protective device according to claim 1 or 2, wherein the cover portion has a reduced diameter portion having an inner diameter that decreases toward the first opening on the side of the first opening. The balloon protective device according to any one of claims 1 to 3, wherein the cover portion has at least one convex portion protruding toward the center of the winding.

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