Patent Application
20120191070
This application claims priority to Japanese Patent Application No. 2011-013667 filed with the Japan Patent Office on Jan. 26, 2011, the entire content of which is hereby incorporated by reference.
The disclosed embodiments relate to a medical device. More specifically, the disclosed embodiments relate to a guidewire.
In the related art, a guidewire is known as a medical device used for percutaneous coronary intervention (hereinafter simply referred to as “PCI”). The guidewire is used to guide a device such as a balloon and a stent to a lesion site.
Such a guidewire is disclosed in, for example, JP-A-4-309368. This guidewire includes a core shaft and a coiled body. The core shaft has a cylindrical base portion and a tapered tip portion connected to the base portion. The coiled body is wound around the outer circumferential surface of the tip portion. The core shaft and the coiled body are brazed to each other at a predetermined position.
The tip portion of the core shaft corresponds to a distal portion of the guidewire. On the other hand, the base portion of the core shaft corresponds to a proximal portion of the guidewire. The distal portion of the guidewire is inserted into the body. The proximal portion of the guidewire is manipulated by an operator such as a physician.
The distal portion of the guidewire in the related art having such a configuration is flexible so as to minimize damage to an inner wall of a vessel caused when the guidewire is inserted into the vessel.
With the guidewire in the related art described in JP-A-4-309368 having the highly flexible tip portion, however, damage to an inner wall of a vessel can be reduced, but on the other hand, it is difficult for the guidewire to penetrate a lesion site.
In particular, it is difficult for this guidewire to penetrate a lesion site of a chronic total occlusion (hereinafter simply referred to as “CTO”). In addition, the guidewire may form a false lumen, even if the guidewire enters a CTO lesion site.
The present inventor has conducted extensive studies to address these problems. As a result of these studies, the present inventor has determined that the torque of the tip portion of the core shaft can be increased by making the diameter of the tip portion larger and that increasing the diameter of the tip portion yields a guidewire having superior CTO penetrating capabilities.
Moreover, the present inventor has determined that, when a guidewire including a core shaft with a tip portion having a larger diameter is inserted into a guiding catheter and a distal portion of the guidewire (tip portion of the core shaft) is made to reach a CTO lesion site, the stiff tip portion having the larger diameter of the core shaft and the vicinity thereof are likely to be subject to plastic deformation at a greatly bent portion of the guiding catheter near a coronary ostium (hereinafter simply referred to as “bent portion of the guiding catheter”). In other words, the present inventor has determined that the core shaft is likely to be subject to plastic deformation at a position away from the distal portion of the guidewire (tip portion of the core shaft).
In addition, the present inventor has also determined that the torque at the distal portion of the guidewire decreases abruptly as a result of plastic deformation of the core shaft.
The present inventor has conducted further studies on the basis of these findings and, consequently, has made a guidewire according to the disclosed embodiments having an excellent torque at a tip portion thereof and being capable of preventing plastic deformation of a core shaft at a position away from a distal portion thereof.
A guidewire according to some embodiments includes: a core shaft having a first tip portion and a first rear end portion opposite to the first tip portion; and a coiled body having a second tip portion and a second rear end portion opposite to the second tip portion and wound around an outer circumferential surface of the first tip portion of the core shaft, wherein the core shaft further includes: a first cylindrical portion to which the second rear end portion is fixed; a second cylindrical portion located closer to the first rear end portion than the first cylindrical portion; and a third cylindrical portion located closer to the first rear end portion than the second cylindrical portion, the second cylindrical portion has an outer diameter substantially larger than an outer diameter of the first cylindrical portion and substantially smaller than a maximum diameter of the coiled body, and the third cylindrical portion has an outer diameter substantially larger than an outer diameter of the second cylindrical portion and substantially smaller than the maximum diameter of the coiled body.
In the guidewire according to some embodiments, the ratio of the outer diameter of the first cylindrical portion to the outer diameter of the second cylindrical portion and to the outer diameter of the third cylindrical portion is preferably within a range of about 1:1.05:1.1 to about 1:2:3.
Preferably, in the guidewire according to some embodiments, the outer diameter of the first cylindrical portion is within a range of about 0.15 mm to about 0.25 mm, the outer diameter of the second cylindrical portion is within a range of about 0.20 mm to about 0.30 mm, and the outer diameter of the third cylindrical portion is within a range of about 0.30 mm to about 0.40 mm.
In the guidewire according to some embodiments, the ratio of the length of the first cylindrical portion to the length of the second cylindrical portion and to the length of the third cylindrical portion is preferably within a range of about 1:4:45 to about 1:7:80.
Preferably, in the guidewire according to some embodiments, the length of the first cylindrical portion is within a range of about 20 mm to about 30 mm, the length of the second cylindrical portion is within a range of about 125 mm to about 135 mm, the length of the third cylindrical portion is within a range of about 1400 mm to about 1600 mm.
In the guidewire according to some embodiments, the first tip portion preferably includes: a cylindrical most distal portion; a first tapered portion connected to the most distal portion and having a diameter increasing toward the first rear end portion side; a middle cylindrical portion connected to the first tapered portion; and a second tapered portion connected to the middle cylindrical portion and having a diameter increasing toward the first rear end portion side.
In the guidewire according to some embodiments, the length of the middle cylindrical portion is preferably within a range of about 2 mm to about 5 mm.
The foregoing and other objects, features, aspects and advantages of the invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.
Preferred embodiments of the present invention will be described below with reference to the accompanying drawings, in which like reference characters designate similar or identical parts throughout the several views thereof.
A guidewire according to a first embodiment of the present invention includes: a core shaft having a first tip portion and a first rear end portion opposite to the first tip portion; and a coiled body having a second tip portion and a second rear end portion opposite to the second tip portion and wound around an outer circumferential surface of the first tip portion of the core shaft, wherein the core shaft further includes: a first cylindrical portion to which the second rear end portion is fixed; a second cylindrical portion located closer to the first rear end portion than the first cylindrical portion; and a third cylindrical portion located closer to the first rear end portion than the second cylindrical portion, the second cylindrical portion has an outer diameter substantially larger than an outer diameter of the first cylindrical portion and substantially smaller than a maximum diameter of the coiled body, and the third cylindrical portion has an outer diameter substantially larger than an outer diameter of the second cylindrical portion and substantially smaller than the maximum diameter of the coiled body.
This guidewire has an excellent torque at the tip portion thereof. Moreover, this guidewire can prevent plastic deformation of the core shaft at a position away from the distal portion thereof.
Typical configurations and effects of this guidewire will be described in detail below with reference to the drawings.
A guidewire 1 according to the first embodiment of the present invention illustrated in
To simplify the explanation, a distal portion of the guidewire 1 and the first tip portion 11 of the core shaft 10 are both denoted with the reference numeral 11 in
The core shaft 10 includes a first cylindrical portion 13 to which the second rear end portion 22 of the coiled body 20 is fixed, a second cylindrical portion 14 located closer to the first rear end portion 12 than the first cylindrical portion 13, and a third cylindrical portion 15 located closer to the first rear end portion 12 than the second cylindrical portion 14.
The outer diameter D2 of the second cylindrical portion 14 is substantially larger than the outer diameter D1 of the first cylindrical portion 13, but substantially smaller than the maximum diameter Dc of the coiled body 20.
The outer diameter D2 of the second cylindrical portion 14 away from the distal portion 11 of the guidewire 1 is substantially larger than the outer diameter D1 of the first cylindrical portion 13 on the side of the distal portion 11. Accordingly, the guidewire 1 has a higher torque than a guidewire having a core shaft with a single diameter having an outer diameter substantially equal to the outer diameter D1 of the first cylindrical portion 13.
In addition, the outer diameter D2 of the second cylindrical portion 14 is substantially smaller than the maximum diameter Dc of the coiled body 20. Accordingly, the second cylindrical portion 14 is highly flexible. Thus, the second cylindrical portion 14 and the vicinity thereof are hardly subject to plastic deformation.
The outer diameter D3 of the third cylindrical portion 15 is substantially larger than the outer diameter D2 of the second cylindrical portion 14, but substantially smaller than the maximum diameter Dc of the coiled body 20.
The outer diameter D3 of the third cylindrical portion 15 on the side of the proximal portion 12 of the guidewire 1 is substantially larger than the outer diameter D2 of the second cylindrical portion 14 on the side of the distal portion 11. Accordingly, the guidewire 1 has a higher torque than a guidewire having a core shaft with a single diameter having an outer diameter substantially equal to the outer diameter D1 of the first cylindrical portion 13 or the outer diameter D2 of the second cylindrical portion 14.
In addition, the outer diameter D3 of the third cylindrical portion 15 is substantially smaller than the maximum diameter Dc of the coiled body 20. Accordingly, the third cylindrical portion 15 is highly flexible. Thus, the third cylindrical portion 15 and the vicinity thereof are hardly subject to plastic deformation.
In this manner, the guidewire 1 is capable of exerting a higher torque and can prevent plastic deformation of the core shaft 10.
The guidewire according to some embodiments will be described in more detail below with reference to the drawings.
The first cylindrical portion 13 and the second cylindrical portion 14 are coupled via a first tapered portion 16. The diameter of the first tapered portion 16 decreases from the rear end portion 12 side toward the first tip portion 11 side. In addition, the second cylindrical portion 14 and the third cylindrical portion 15 are coupled via a second tapered portion 17. The diameter of the second tapered portion 17 decreases from the rear end portion 12 side toward the first tip portion 11 side.
The outer diameter D2 of the second cylindrical portion 14 is substantially larger than the outer diameter D1 of the first cylindrical portion 13 and substantially smaller than the maximum diameter Dc of the coiled body 20. The outer diameter D3 of the third cylindrical portion 15 is substantially larger than the outer diameter D2 of the second cylindrical portion 14, but substantially smaller than the maximum diameter Dc of the coiled body 20.
The ratio of the outer diameter D1 of the first cylindrical portion 13, the outer diameter D2 of the second cylindrical portion 14 and the outer diameter D3 of the third cylindrical portion 15 is preferably within a rage of about 1:1.05:1.1 to about 1:2:3 for at least the following reason.
With the ratio of the outer diameter D1 of the first cylindrical portion 13, the outer diameter D2 of the second cylindrical portion 14 and the outer diameter D3 of the third cylindrical portion 15 being within the above range, a balanced change in the diameter from the first tip portion 11 of the core shaft 10 to the first rear end portion 12 contributes to a higher torque applied to the core shaft 10. As a result, it is possible to prevent plastic deformation of the core shaft 10 more reliably.
The outer diameter D1 of the first cylindrical portion 13 is more preferably within a range of about 0.15 to about 0.25 mm. The outer diameter D2 of the second cylindrical portion 14 is more preferably within a range of about 0.20 to about 0.30 mm. The outer diameter D3 of the third cylindrical portion 15 is more preferably within a range of about 0.30 to about 0.40 mm.
The ratio of the length L1 of the first cylindrical portion 13, the length L2 of the second cylindrical portion 14 and the length L3 of the third cylindrical portion 15 is preferably within a rage of about 1:4:45 to about 1:7:80 for at least the following reason.
With the ratio of the length L1 of the first cylindrical portion 13, the length L2 of the second cylindrical portion 14 and the length L3 of the third cylindrical portion 15 being within the above range, the second cylindrical portion 14, the second tapered portion 17 or the third cylindrical portion 15, which are less likely to be subject to plastic deformation, is often positioned at the greatly bent portion of the guiding catheter near a coronary ostium when the guidewire 1 according to the present embodiment is inserted into the guiding catheter. It is therefore possible to prevent plastic deformation of the core shaft 10 more reliably.
The length L1 of the first cylindrical portion 13 is more preferably within a range of about 20 mm to about 30 mm. The length L2 of the second cylindrical portion 14 is more preferably within a range of about 125 mm to about 135 mm. The length L3 of the third cylindrical portion 15 is more preferably within a range of about 1400 mm to about 1600 mm.
The interval between an end of the second cylindrical portion 14 on the side of the first tip portion 11 and a most distal portion 26 is preferably within a range of about 200 mm to about 300 mm for at least the following reason.
When the guidewire 1 according to some embodiments is used for a retrograde approach, the second cylindrical portion 14, or the vicinity thereof, is substantially positioned at the bent portion of the guiding catheter. Accordingly, a higher torque is applied to the core shaft 10. As a result, it is possible to prevent plastic deformation of the core shaft 10 more reliably.
Next, a detailed configuration of the distal portion 11 of the guidewire 1 will be described with reference to the drawings.
In the distal portion of the guidewire 1 illustrated in
In this manner, the diameter of the first tip portion of the core shaft 10 gradually increases. Therefore, the first tip portion of the core shaft 10 has a higher strength and can exhibit a higher torque.
More preferably, the middle cylindrical portion 32 has a length (length in the longitudinal direction of the core shaft 10) within a range of about 2 mm to about 5 mm.
The cylindrical most distal portion 30 of the core shaft 10 is bonded to the coiled body 20 at the semispherical most distal portion 26 of the guidewire 1.
Examples of the material for the core shaft 10 illustrated in
Examples of the stainless steel include martensite-based stainless steel, ferrite-based stainless steel, austenite-based stainless steel, austenitic-ferritic duplex stainless steel, and precipitation-hardened stainless steel.
Among these, the austenite-based stainless steel is preferable, and more preferable examples thereof include SUS304, SUS316, and SUS316L.
Examples of the material for the most distal portion 26 include super elastic alloys such as a Ni—Ti alloy; a piano wire; a tungsten wire and other materials.
The coiled body 20 includes a strand spirally wound around the outer circumferential surface of the first tip portion 11 of the core shaft 10.
Preferred examples of the material for the strand constituting the coiled body 20 include stainless steel such as martensite-based stainless steel, ferrite-based stainless steel, austenite-based stainless steel, austenitic-ferritic duplex stainless steel, and precipitation-hardened stainless steel; super elastic alloys such as an Ni—Ti alloy; and radiopaque metals such as platinum, gold, and tungsten.
The strand preferably has a diameter within a range of about 0.03 mm to about 0.08 mm.
The coiled body 20 preferably has a cross-section, along the longitudinal direction of the guidewire 1, having a tapered shape with the diameter decreasing toward the first tip portion 11.
The coiled body 20 having such a tapered shape facilitates insertion of the guidewire 1 into a CTO lesion site.
The coiled body 20 has a coil tip end brazing portion 23, a coil middle brazing portion 24 located closer to the second rear end portion 22 than the coil tip end brazing portion 23, and a coil rear end brazing portion 25 located closer to the second rear end portion 22 than the coil middle brazing portion 24. The brazing portions (23, 24 and 25) are brazed to the core shaft 10.
Note that the coil middle brazing portion 24 may be formed at one position or at a plurality of positions.
Examples of the material for brazing metal include aluminum alloy solder, silver solder, gold solder, zinc, Sn—Pb alloy, Pb—Ag alloy, and Sn—Ag alloy.
The outer surface of the guidewire 1 may be coated with a hydrophilic material. This can lower the sliding resistance of the guidewire 1 in the guiding catheter, in a tubular organ, or in an intracorporeal tissue. As a result, the guidewire 1 can be moved smoothly.
Examples of the hydrophilic material include cellulose-based polymeric substance, polyethylene oxide-based polymeric substance, maleic anhydride-based polymeric substance (e.g., maleic anhydride copolymer such as methylvinyl ether-maleic anhydride copolymer), acrylamide-based polymeric substance (e.g., polyacrylamide, and polyglycidyl methacrylate-dimethylacrylamide block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, and hyaluronate.
Among these, hyaluronate is preferable.
The guidewire 1 according to the present embodiment includes the first cylindrical portion 13, the second cylindrical portion 14 and the third cylindrical portion 15 having the predetermined shapes as described above. Accordingly, the distal portion of the guidewire 1 is capable of exerting a higher torque and it is possible to prevent plastic deformation of the core shaft 10.
The guidewire 1 of the present embodiment can be produced as follows, for example. First, the core shaft 10 is formed by tapering a rod so that the core shaft 10 has the predetermined shape as described above. Then, the tip portion of the formed core shaft 10 is inserted into the coiled body 20. Then, the core shaft 10 and the coiled body 20 are brazed at a predetermined position.
Examples of the tapering process include a cutting process such as centering grinding, a swaging process, and a drawing process.
The guidewire 1 of the present embodiment can be suitably used for PCI, for example.
In particular, the guidewire 1 is particularly suitable for use in the retrograde approach technique. According to this technique, the guidewire 1 is inserted into a deeper point in a coronary artery.
This technique will be explained below.
According to the retrograde approach, the guidewire does not directly approach a stenotic lesion site. The guidewire approaches a lesion site in a direction opposite to that in the conventional technique via a specific vessel (e.g., a thin vessel called a collateral channel).
Specifically, if there is a lesion site in the right coronary artery, the guidewire approaches the lesion site through a right coronary artery ostium according to the antegrade approach that is normally employed. According to the retrograde approach, on the other hand, the guidewire approaches the lesion site through a left coronary artery ostium, passes through the collateral channel and reaches the lesion site.
The retrograde approach is considered to be suitable for treatment of a relatively severe lesion site that is difficult to treat according to the conventional antegrade approach.
In an operation for PCI, the guiding catheter is greatly bent near a coronary ostium. As a result, the tip portion of the guiding catheter is inserted into the coronary ostium. The guidewire is inserted into the guiding catheter.
According to the retrograde approach described above, the guidewire follows a longer detour path. The guidewire is thus inserted to a deeper point (e.g., a site about 300 mm away from the coronary ostium) in the coronary artery. Accordingly, a portion that is about 300 mm away from the distal portion of the guidewire is greatly bent along the bent portion of the guiding catheter. Thus, with a guidewire of the related art, a portion about 300 mm away from the distal portion is easily subject to plastic deformation.
The guidewire according to some embodiments, however, includes a first cylindrical portion, second cylindrical portion and third cylindrical portion having the predetermined shapes as described above. It is therefore possible to prevent plastic deformation of the core shaft. Moreover, it is also possible to prevent a great loss in the torque of the distal portion of the guidewire.
As described above, the guidewire according to some embodiments can be particularly suitable for use in the retrograde approach.
A proximal portion of a guidewire may have an attachment structure for attaching an operating portion such as a torquer. Alternatively, a proximal portion of a guidewire may include an extension wire attaching portion for attaching an extension wire for extending the length of the guidewire.
While the foregoing embodiments have been shown and described in detail, the foregoing description is in all aspects illustrative and not restrictive. It is therefore understood that numerous modifications and variations can be devised without departing from the spirit and scope of the foregoing embodiments.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2011-013667 | Jan 2011 | JP | national |
