Patent Application
20150066132
The present disclosure relates to a balloon catheter and a stent delivery system, and more specifically, to a balloon catheter and a stent delivery system used for treating a stenosed part or an occluded part occurring inside a living body lumen.
A balloon catheter is a medical device used for widening a lesion when the lesion such as a stenosed part or an occluded part occurs inside a living body lumen such as a blood vessel, a bile duct, the trachea, the esophagus, and the urethra. For example, for the medical treatment of myocardial infarction, angina pectoris, and the like which are caused due to an occurrence of a stenosed part in a coronary artery, for example, a method of widening the stenosed part from the inside of the stenosed part by using a balloon catheter is adopted.
This type of a balloon catheter generally has a structure in which a balloon is arranged in an outer peripheral portion on a distal end side of an elongated shaft body. After the shaft body is inserted into the living body lumen until the balloon is positioned in a lesion, the balloon is dilated in a radial direction to widen the lesion by supplying a dilation fluid into the balloon through the inside of the shaft body.
JP-A-2008-86463 discloses a balloon catheter in which a balloon 3 is attached to the shaft body having a dual-tube structure including an outer tube 1 and an inner tube 2, and which is illustrated in
As shown in
A balloon having a size in accordance with the part to be applied, the lesion, or the like is used as a balloon 3. However, generally, the maximum dilation pressure, which is the upper limit value of a dilation pressure that can be safely used, is set in advance in a balloon. The outer diameter of the balloon 3 during dilation can be adjusted by changing an injection pressure of a dilation fluid F, which is supplied to a dilation chamber 4 within a range not exceeding the maximum dilation pressure. For example, when the injection pressure of the dilation fluid F is increased, a dilation outer diameter of the balloon 3 can be widened as indicated by the two-dot chain line in
However, when the dilation outer diameter of the balloon 3 is widened by increasing the injection pressure of the dilation fluid F, the balloon 3 is also stretched in an axial direction together with an inner tube 2 causing a stretch E occurring between a distal end portion 3a and a proximal end portion 3b of the balloon 3. Thus, there is a possibility that the balloon 3 may also impose a burden to normal living body lumens other than the lesion.
The present disclosure provides a balloon catheter and a stent delivery system in which a stretch occurring between a distal end portion and a proximal end portion of a balloon can be relatively suppressed during dilation of the balloon.
In accordance with an exemplary embodiment, a balloon catheter is disclosed, which includes an elongated shaft body, a dilatable balloon in which a distal end portion and a proximal end portion form a dilation chamber inside of the dilatable balloon by being away from each other and being individually bonded to an outer periphery of the shaft body, and a stretch regulation member that connects the outer periphery of the shaft body or an inner periphery of the balloon in the vicinity of the distal end portion of the balloon and the outer periphery of the shaft body or the inner periphery of the balloon in the vicinity of the proximal end portion of the balloon with each other inside the dilation chamber while regulating a stretch occurring between the distal end portion and the proximal end portion of the balloon during dilation of the balloon.
In accordance with an exemplary embodiment, the shaft body can include an outer tube which has a distal end opening portion and an inner tube which is inserted into the outer tube to form a balloon dilation lumen between itself and an inner peripheral surface of the outer tube and has a forward extension portion extending forward beyond the distal end opening portion of the outer tube. The distal end portion of the balloon preferably forms a distal end side bonding portion by being bonded to an outer periphery of the forward extension portion of the inner tube. The proximal end portion of the balloon preferably forms a proximal end side bonding portion by being bonded to an outer periphery of the outer tube. The dilation chamber preferably communicates with the balloon dilation lumen.
In accordance with an exemplary embodiment, the stretch regulation member can be formed with a plurality of filaments which respectively extend between the distal end side bonding portion and the proximal end side bonding portion and are arranged in a circumferential direction of the shaft body at equal intervals.
The filaments can be formed of metallic materials or stretch-resistant resin materials.
In accordance with an exemplary embodiment, the stretch regulation members can be configured to include three filaments.
In accordance with an exemplary embodiment, a stent delivery system according to the present disclosure includes the balloon catheter disclosed above, and a stent that is arranged in an outer periphery of a balloon of the balloon catheter and expands in accordance with dilation of the balloon.
In accordance with an exemplary embodiment of the present disclosure, a stretch regulation member can connect an outer periphery of a shaft body or an inner periphery of a balloon in the vicinity of a distal end portion of the balloon and the outer periphery of the shaft body or the inner periphery of the balloon in the vicinity of a proximal end portion of the balloon with each other, and thus, a stretch occurring between the distal end portion and the proximal end portion of the balloon during dilation of the balloon can be relatively suppressed.
In accordance with an exemplary embodiment, a balloon catheter is disclosed comprising: an elongated shaft body, the shaft body including an outer tube which has a distal end opening portion, and an inner tube which is inserted into the outer tube to form a balloon dilation lumen between the inner tube and an inner peripheral surface of the outer tube and has a forward extension portion extending forward beyond the distal end opening portion of the outer tube; a dilatable balloon in which a distal end portion and a proximal end portion form a dilation chamber inside of the dilatable balloon by being away from each other and being individually bonded to an outer periphery of the shaft body; and a plurality of filaments that connect the outer periphery of the shaft body or an inner periphery of the balloon of the distal end portion of the balloon and the outer periphery of the shaft body or an inner periphery of the balloon of the proximal end portion of the balloon with each other inside the dilation chamber while regulating a stretch occurring between the distal end portion and the proximal end portion of the balloon during dilation of the balloon.
In accordance with an exemplary embodiment, a method is disclosed of regulating a stretch occurring between a distal end portion and a proximal end portion of a dilatable balloon during dilation, comprising: placing a stretch regulation member that connects an outer periphery of an elongated shaft body or an inner periphery of the balloon of the distal end portion of the balloon and an outer periphery of the elongated shaft body or an inner periphery of the balloon of the proximal end portion of the balloon with each other inside a dilation chamber of the dilatable balloon.
As illustrated in
The balloon 12 has a middle portion 12c which is provided in the middle of the balloon 12 and of which an outer diameter is substantially uniform. The balloon 12 has a distal end portion 12a which is provided closer to a distal end side than the middle portion 12c and of which an outer diameter is smaller than that of the middle portion 12c, and a proximal end portion (“rear end portion”) 12b which is provided closer to a proximal or rear end side than the middle portion 12c and of which an outer diameter is smaller than that of the middle portion 12c. The balloon 12 also includes a distal end side tapered portion 12d which is provided between the distal end portion 12a and the middle portion 12c, and a proximal end side tapered portion (‘rear end side tapered portion”) 12e which is provided between the proximal end portion 12b and the middle portion 12c.
The outer tube 17 has a distal end opening portion 20, and the inner tube 18 has a forward extension portion 18a extending closer to the distal end side than the distal end opening portion 20 of the outer tube 17, that is, further forward of distal end opening portion 20 of the outer tube 17. A distal end side bonding portion 21 is formed by bonding the distal end portion 12a of the balloon 12 to an outer periphery of the forward extension portion 18a of the inner tube 18, and a proximal end side bonding portion (“rear end side bonding portion”) 22 is formed by bonding the proximal end portion 12b of the balloon 12 to an outer periphery of the distal end of the outer tube 17. Accordingly, a dilation chamber 23 communicating with the balloon dilation lumen 19 can be formed inside the balloon 12.
Inside the dilation chamber 23 of the balloon 12, the balloon 12 can include three filaments 24 extending between the distal end side bonding portion 21 and the proximal end side bonding portion 22. The three filaments 24 can be respectively fixed between the outer periphery of the inner tube 18 (forward extension portion 18a) and the inner periphery of the balloon 12 (distal end portion 12a) in the distal end side bonding portion 21, and between the outer periphery of the outer tube 17 and the inner periphery of the balloon 12 (proximal end portion 12b) in the proximal end side bonding portion 22. In accordance with an exemplary embodiment, the three filaments 24 connect the distal end side bonding portion 21 and the proximal end side bonding portion 22 with each other and function as stretch regulation members regulating a stretch occurring between the distal end portion 12a and the proximal end portion 12b of the balloon 12 during dilation of the balloon 12. In accordance with an exemplary embodiment, the filaments 24 can be arranged in a circumferential direction of the forward extension portion 18a of the inner tube 18 at equal intervals, as illustrated in
Inside the dilation chamber 23 of the balloon 12 and on the outer periphery of the forward extension portion 18a of the inner tube 18, contrast markers 25 can be respectively arranged in the vicinity of the distal end portion 12a and the proximal end portion 12b of the balloon 12. In accordance with an exemplary embodiment, on account of these contrast markers 25, a position of the balloon 12 which is inserted into a living body lumen can be confirmed from the outside of a living body through an X-ray contrast.
The Inside of the inner tube 18 of the shaft body 11 communicates with the operation port 15 of the branch hub 13, and the guide wire 14 is inserted through the overall length of the inner tube 18 and the operation port 15.
The balloon dilation lumen 19 formed between the outer tube 17 and the inner tube 18 of the shaft body 11 communicates with the fluid port 16 of the branch hub 13 so that the dilation fluid can be injected to the inside of the dilation chamber 23 of the balloon 12 from the fluid port 16 via the balloon dilation lumen 19. In this case, the distal end side bonding portion 21 which is positioned on the outer periphery of the forward extension portion 18a of the inner tube 18 and the proximal end side bonding portion 22 which is positioned on the outer periphery in the vicinity of the distal end of the outer tube 17 are connected with each other by the filaments 24. As illustrated in
In accordance with an exemplary embodiment, for example, it can be preferable to use a material having certain flexibility as a material forming the outer tube 17 and the inner tube 18 of the shaft body 11. For example, the outer tube 17 and the inner tube 18 of the shaft body 11 can be a resin material such as polyolefin such as polyethylene, polypropylene, an ethylene-propylene copolymer and an ethylene-vinyl acetate copolymer, polyvinyl chloride, polyurethane, polyamide, a polyamide elastomer, polyimide, a silicon resin, polyether ether ketone, polyester, a polyester elastomer, and the like.
In accordance with an exemplary embodiment, for example, it can be preferable to form the balloon 12 with a high strength polymer, which can be stretchable. For example, the balloon 12 can be a resin material such as polyethylene terephthalate, polyester in which a main acid component or a main glycol component of polyethylene terephthalate is changed, a polyester elastomer, polyamide (nylon 12, nylon 11, MXD 6 nylon, and the like), a polyamide elastomer, polyarylene sulfide such as PPS (polyphenylene sulfide).
In accordance with an exemplary embodiment, for example, it can be preferable to form the filaments 24 used as the stretch regulation member with a material which has certain flexibility so as not to lessen softness in a portion corresponding to the balloon 12 while being unlikely to stretch against a tension force acting during dilation of the balloon 12. As a constituent material of the filament 24, for example, a metallic material or a stretch-resistant resin material can be used.
In accordance with an exemplary embodiment, since a metallic material generally has a greater Young's modulus than a resin material constituting the inner tube 18 and the balloon 12, the filament 24 is unlikely to stretch even though the filament 24 is formed to have a small diameter, thereby being suitable to be used as a constituent material of the filament 24. As a metallic material, for example, stainless steel such as SUS 304, SUS 316L can be used.
A stretch occurring between the distal end portion 12a and the proximal end portion 12b of the balloon 12 can be relatively suppressed when forming the filament 24 with a stretch-resistant resin material. In accordance with an exemplary embodiment, for example, it can also be effective when a fiber-reinforced resin, which is reinforced by a glass fiber, carbon fiber, and the like is used.
The contrast marker 25 can be formed of a material, which can be relatively easily, confirmed through an X-ray contrast, for example, gold, platinum, iridium, tungsten, an alloy of gold, platinum, iridium or tungsten, or a silver-palladium alloy.
When manufacturing a balloon catheter, the distal end portions of three filaments 24 can be in states of being respectively inserted between an inner peripheral surface of the distal end portion 12a of the balloon 12 and an outer peripheral surface of the forward extension portion 18a of the inner tube 18, and then, the inner peripheral surface of the distal end portion 12a of the balloon 12 can be fused on the outer peripheral surface of the forward extension portion 18a of the inner tube 18. Therefore, in accordance with an exemplary embodiment, the distal end side bonding portion 21 can be formed and each distal end portion of the filaments 24 can be fixed to the distal end side bonding portion 21 at the same time. Similarly, the proximal end portions (“rear end portions”) of three filaments 24 can be in states of being respectively inserted between an inner peripheral surface of the proximal end portion 12b of the balloon 12 and an outer peripheral surface in the vicinity of the distal end of the outer tube 17, and then, the inner peripheral surface of the proximal end portion 12b of the balloon 12 can be fused on the outer peripheral surface of the outer tube 17. Therefore, in accordance with an exemplary embodiment, the proximal end side bonding portion 22 can be formed and each proximal end portion of the filaments 24 can be fixed to the proximal end side bonding portion 22 at the same time.
In accordance an exemplary embodiment, operations of the exemplary embodiments as shown in
In accordance with an exemplary embodiment, initially, the guide wire 14 inserted into the inner tube 18 of the shaft body 11 from the operation port 15 is caused to protrude forward beyond the distal end portion of the inner tube 18, and the guide wire 14 serves as a leading guide for the balloon catheter to be inserted into the living body lumen such as a blood vessel. In this case, the dilation fluid is not yet injected into the dilation chamber 23 of the balloon 12 and the balloon 12 is in a folded state. An X-ray contrast is performed to recognize the contrast marker 25 arranged inside the dilation chamber 23 of the balloon 12 to confirm a position of the balloon 12 inside a living body lumen.
An insertion operation of the balloon catheter is completed, once the positioning of the balloon 12 is confirmed in the lesion requiring treatment. Here, the dilation fluid can be injected into the dilation chamber 23 of the balloon 12 through the balloon dilation lumen 19 from the fluid port 16. The balloon 12 can then be dilated until the target outer diameter is acquired while confirming the injection pressure of the dilation fluid. Accordingly, the lesion such as a stenosed part or an occluded part can be widened.
In this case, a tension force acts in the balloon 12 and the inner tube 18 along the axial direction in accordance with the injection pressure of the dilation fluid. However, since the distal end side bonding portion 21 which is positioned on the outer periphery of the forward extension portion 18a of the inner tube 18 and the proximal end side bonding portion 22 which is positioned on the outer periphery in the vicinity of the distal end of the outer tube 17 are connected with each other by three filaments 24, a stretch occurring between the distal end portion 12a and the proximal end portion 12b of the balloon 12 is regulated by the filaments 24. Accordingly, the balloon 12 can be relatively suppressed from being stretched in the axial direction.
For example, in this manner, it is possible to help prevent dilation of the balloon 12 in advance such that the balloon 12 does not impose a burden to normal living body lumens other than the lesion while dilating a lesion such as a stenosed part and an occluded part.
When the treatment of the lesion ends, the balloon 12 is folded by suctioning the dilation fluid from the inside of the dilation chamber 23 of the balloon 12 via the balloon dilation lumen 19, and then, in this state, the balloon catheter is drawn out from the inside of the living body lumen.
In accordance with an exemplary embodiment, the number of filaments 24 used as the stretch regulation member is not limited to three. For example, as long as the filament can regulate a stretch without lessening the softness of the balloon catheter in a portion corresponding to the balloon 12, it is possible to adopt equal to or less than two, or equal to or more than four filaments 24.
In accordance with an exemplary embodiment, in place of the filament 24, a member having a rod shape or a plate shape may be used as the stretch regulation member. However, in this case, it can be desirable not to lessen the softness of the balloon catheter in a portion corresponding to the balloon 12.
In the exemplary embodiment disclosed above, although both the end portions of each filament 24 are respectively fixed to the distal end side bonding portion 21 and the proximal end side bonding portion 22 of the balloon 12, it is not limited thereto. For example, as illustrated in
In accordance with an exemplary embodiment, in this manner, even if the positions P1 and P2 of both the end portions of each filament 24 are slightly deviated from the distal end portion 12a and the proximal end portion 12b of the balloon 12, when the outer periphery of the forward extension portion 18a of the inner tube 18 in the vicinity (specifically, distal end side tapered portion 12d) of the distal end portion 12a of the balloon 12 and the outer periphery of the outer tube 17 in the vicinity (specifically, proximal end side tapered portion 12e) of the proximal end portion 12b of the balloon 12 are connected by each of the filaments 24, a stretch occurring between the position P1 and the position P2 can be relatively suppressed on account of an existence of the filaments 24 during dilation of the balloon 12, and thus, a certain degree of the stretch occurring between the distal end portion 12a and the proximal end portion 12b of the balloon 12 can be regulated.
In accordance with an exemplary embodiment, as shown in
As illustrated in
In this manner, for example, even though the positions P3 and P4 of both the end portions of each of the filaments 24 are slightly deviated from the distal end portion 12a and the proximal end portion 12b of the balloon 12, when the inner periphery of the balloon 12 in the vicinity (specifically, distal end side tapered portion 12d) of the distal end portion 12a of the balloon 12 and the inner periphery of the balloon 12 in the vicinity (specifically, proximal end side tapered portion 12e) of the proximal end portion 12b of the balloon 12 are connected by each of the filaments 24, a stretch occurring between the position P3 and the position P4 can be relatively suppressed on account of an existence of the filaments 24 during dilation of the balloon 12, and thus, a certain degree of the stretch occurring between the distal end portion 12a and the proximal end portion 12b of the balloon 12 can be regulated.
In accordance with an exemplary embodiment, as shown in
In the exemplary embodiment as disclosed, the description is given regarding a so-called over-the-wire-type balloon catheter in which the guide wire 14 is inserted through from the proximal end portion having the branch hub 13 attached thereto to the distal end portion, the disclosure can be similarly applied to a so-called rapid-exchange-type balloon catheter in which the guide wire is inserted through only the distal end portion.
As illustrated in
The detailed description above describes a balloon catheter and a stent delivery system. The disclosure is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can effected by one skilled in the art without departing from the spirit and scope of the disclosure as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2012-057448 | Mar 2012 | JP | national |
This application is a continuation of International Application No. PCT/JP2013/052845 filed on Feb. 7, 2013, and claims priority to Japanese Application No. 2012-057448 filed on Mar. 14, 2012, the entire content of both of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/JP2013/052845 | Feb 2013 | US |
| Child | 14478283 | US |
