JP2003530132A - Directional guidewire - Google Patents

Abstract

SUMMARY OF THE INVENTION A directional medical guidewire having two ends and an outer surface for insertion through a lumen, the guidewire comprising the following parts: resilient and flexible. An elongate body, the body having a main portion deflected to a first shape; and a distal end, the distal end being continuous with one end of the main portion, defined by a curved shape; The curved shape has a first portion with a first curved portion and a second portion with a second curved portion different from that of the first portion. The invention further includes a kit using a guidewire of the invention and a guide catheter having a directional medical guidewire disposed therein.

Description

Detailed Description of the Invention

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to guidewires used in medical applications, and more particularly to improvements in guidewires used in endoluminal implant placement.

2. Description of Related Art The intraluminal placement of prosthetic devices (eg, stents and grafts) to perform surgical procedures intraluminally has recently increased dramatically. Many of these installations and procedures require first positioning the guidewire at the desired portion of the lumen of the desired vessel or conduit (eg, blood vessel). Once the initial guidewire is in place, a catheter or other tubular device may be positioned over the guidewire, which may guide other guidewires, prostheses, endoscopes or surgical instruments. Used to deliver to the desired blood vessel or conduit.

There are various techniques for positioning a guidewire intraluminally, however, often physicians encounter problems in positioning the guidewire in a desired manner.
One technique used is to use a directional catheter in which a guide wire is passed between them in the desired direction. Such a directional catheter can, for example, have a curved end that directs a guidewire through and out of it in a desired direction (eg, within a branch vessel).

SUMMARY OF THE INVENTION According to a first aspect, the present invention resides in a directional medical guidewire for insertion through a body vessel or cavity, the guidewire comprising: A resilient, flexible elongate body having a main body, which usually exhibits a linear shape; and a distal end continuous with one end of the main body, which is The guidewire has a curved shape at the distal end that includes a first portion (which usually has a first bend) and a second portion (which is usually the first portion). A second curved portion different from that of the above).

For the purposes of this specification, the general shape of a guidewire according to the present invention is that the guidewire is adapted to suspend the guidewire outside the body, from the distal end distal to its distal end. It is chosen to be a shape that can be adapted and hung freely. Therefore, the normally straight body of the guidewire is expected to extend substantially vertically as it is hung from its distal end. Similarly, the normal curvature of any portion of the guidewire is the curvature accommodated by the guidewire when sagging as described above. During use, the shape exhibited by some of the guidewires changes from their normal shape as it passes through the blood vessels or cavities of the body due to the elastic and flexible nature of the guidewires. The shape of the guidewire during storage or dispensing can also vary from what it normally exhibits. For example, the guidewire can be wrapped and then packaged for dispensing and can assume its normal shape only when unpacked.

In one embodiment of the invention, the second part may be continuous with the end of the first part.
In a further embodiment, the distal end of the guidewire can have a third section continuous with the end of the second section, which usually has a third different curvature different from the second section. . Instead of having a curvature, the third portion may also be generally substantially straight with respect to the curvature of the second portion. It can also be envisioned that the distal end has a fourth or greater number of curved or straight sections, depending on how tortuous the vessel being treated is.

Each of the first, second and further portions of the terminal end is usually a notation (not).
can have a circular, oval or similar curved shape. For example, the first portion may have a curvature of a first supposed circle having a first radius and the second portion has a curvature of a second supposed circle having a second radius different from that of the first circle. be able to. In another example, the first portion can have an assumed circular curvature and the second portion can have an assumed elliptical curvature. In yet another example, the first portion can have an assumed elliptical curvature and the second portion can have an assumed circular curvature. In yet another example, the first portion can have the curvature of the first supposed ellipse and the second portion can have the curvature of the second supposed ellipse.

The first and second portions of the distal end of the guidewire can be separated by an intermediate portion. This middle portion can usually have a linear shape, or it can have a curved shape, which typically has a different normal curvature than what the first and second parts normally exhibit. If the middle part usually has a curved shape, this middle part is
It can have an assumed circle, ellipse or parabolic curvature.

In yet another embodiment, the distal end has a constant bend angle between the first and second portions such that the first and second curved portions are of opposite curvature. The curvature of the first and second portions can also define a hypothetical plane, the curvature of the second portion being in a hypothetical plane different from that of the first portion.

In an embodiment of the invention having a generally straight middle portion, the normal curvature of the first portion is
Preferably, the middle portion is at an angle between 10 ° and 135 ° with respect to the longitudinal axis of the generally straight section. When guidewires are used in the placement of endoluminal implants in the aorta and associated iliac arteries, the angles are more preferably 20 ° and 45 °.
Most preferably between about 30 ° and about 30 °. The curvature of the second curved section is also preferably such that the longitudinal axis of the middle section makes an angle between 10 ° and 135 °, and the assumed straight line extends from the end of the second section or is actually The normally straight portion is continuous with the free end of the second portion. When the guidewire is used in the placement of an endoluminal implant in the aorta and associated iliac arteries, this angle is more preferably 3
Between 0 ° and 60 °, most preferably about 45 °.

The length of the intermediate section can be set to suit the application of the guide wire. For use in endoluminal implant placement, the length is between 1 cm and 6 cm, and more preferably
It can be between about 3 cm and 4 cm.

The guide wire can be made of metal or metal alloy. For example, the guide wire can be made from a nitinol alloy. The guide wire is designed to reduce friction
Along its length, it can be coated with a suitable material, such as a biocompatible silicone-based lubricant.

In a second aspect, the invention includes a kit having a guide catheter having a directional medical guidewire (as defined herein) disposed therein.

In yet another aspect, the invention includes a method of locating a guidewire as defined herein within a blood vessel of a body, which branch from a first blood vessel. Introducing the kit according to the second aspect of the invention into a first blood vessel.

Briefly, a new and enhanced guidewire iterat
ions), which are provided with curved ends, and methods of using them, eg, for endovascular implantation.

According to a feature of the invention, a directional medical guide wire is provided, the guide wire having two ends and an outer surface for insertion through a lumen, the guide wire comprising: A resilient, flexible elongate body having a main portion biased to a first shape; and a distal end, the distal end being one end of the primary portion. Is continuous and is defined by a curved shape, the curved shape having a first portion with a first curved portion and a second portion having a second curved portion different from that of the first portion.

According to another feature of the invention, there is provided a method of installing a guide wire according to claim 1, wherein the guide wire is adapted to be hung outside a body having a lumen. The end distal to the end is free to hang.

In yet another aspect of the invention, there is provided a method of using the guidewire of claim 1, the method comprising wrapping the guidewire into a spring biased state during storage. Changing the shape of the guide wire; wrapping the guide wire; removing the guide wire; and reconstituting the undeflected orientation of the guide wire within the lumen.

According to yet another aspect of the invention there is provided a guidewire according to claim 1, wherein the guidewire further comprises nitinol, nickel, titanium, stainless steel, elgiloy, palladium and similar ultra-wires. It comprises at least one metal and alloy selected from the group consisting of elastic or flexible, substantially metallic or magnetic combinations.

In yet another aspect of the invention, there is provided a guidewire according to claim 1, wherein said outer surface is at least selected from the group consisting of PET, PTFE, silicone based lubricants and similar plastic based materials. It is coated with one biocompatible substance.

The kit includes a guide catheter having a directional medical guidewire disposed therein; a first means for installing the guidewire; a means for adjusting the installed guidewire; and for installing the guidewire. Including the second means of.

DETAILED DESCRIPTION OF THE INVENTION The present invention, whether or not a guidewire is intended for placement of an endoluminal implant in other surgical procedures, is used when it is needed to direct it into a vessel of the body. Can be used in surgical procedures. Examples of blood vessels that may need to be steered with a guide wire include the renal, bladder and iliac arteries.

The present invention is described below with reference to examples of placing an endoluminal implant in a patient to achieve at least one of aortic aneurysm bridging and occlusion. Slightly skilled surgeons are aware of related procedures and locations including, but not limited to, chest position and the like.

As can be seen in FIG. 1, the aorta 10 branches into the right and left iliac arteries 12, 13. The aortic aneurysm 14 is located between the renal arteries 15 and 16, and is located in the left iliac artery 13
It is growing downward. One means of bridging the aneurysm 14 may be to use a trouser-like implant 17, which comprises a branch and a pair of short tubular extensions 19,19.
a, which is connected to tubular grafts 17a, 17b, which extend down into the iliac arteries 12, 13 respectively. One such trouser-like implant is described in Australian Patent Specification No. AU-A-78035 /
94, the contents of which are incorporated herein by reference.

A method of locating an endoluminal implant will now be described with reference to Figures 2a-i.
In performing this method, an incision or puncture is made to expose one of the (eg, ipsilateral) femoral arteries, which is flowing from the corresponding iliac artery, and Se
Using the ldinger needle technique, a 0.035 ft (0.035 ') diameter tipped flexible guidewire was inserted there through the femoral artery and then
The iliac artery 12 is inserted into the aorta 10 so that it crosses the aneurysm 14. Then
An 8 French hemostatic sheath is introduced over the guide wire to control bleeding. An angiographic catheter is then introduced and an angiogram of the patient is taken to reveal the location of renal arteries 15, 16 and other related anatomy within the patient.

An Amplatz super-rigid AES guidewire 23 (0.035 feet (0.035 ′) in diameter) is then passed through the angiographic catheter and into the aorta 10. After withdrawing this angiographic catheter, the rigid guidewire 23 remains in its original position. The sheath 21 (preferably 24 French) and dilator are then introduced over the rigid guidewire 23 into the aorta 10 (see Figure 2a). Next, the balloon catheter 24 is introduced into the sheath 21.

As can be seen in FIG. 4, the balloon catheter 24 is a delivery catheter, which comprises a bifurcated implant 17 (which has a bifurcated point 17c) and an ipsilateral extension 1.
9, the contralateral extension 19a, and the thin catheter 25 (which includes the guidewire 26
The guidewire extends up through the ipsilateral tubular graft extension 19 in a first direction and then over a contralateral extension 19a in a second different direction).
It is pre-packaged with.

When correctly positioning the balloon catheter 24 within the aorta 10, the sheath 21 is
Partially withdrawn to release the implant so that the balloon 20 can be inflated (see Figure 2b). Inflating the balloon 20 of the catheter 24 expands the upstream end of the first graft 17 and engages the aortic wall above the aortic aneurysm but downstream from the renal arteries 15,16. . The first graft 17 is of such length that the short tubular extensions 19, 19a are completely positioned within the aorta 10. The balloon 20 is then deflated, but the balloon catheter is
It remains in place (see Figure 2c). The deflation of the balloon 20 causes blood to flow under the implant 17 and spread the first implant 17 and the tubular extensions 19, 19a.

The thin catheter 25 is preferably 3 French and the resilient, flexible guide wire 26 is preferably composed of a nitinol alloy core with a hydrophilic coating. Once the first implant 17 is in place, it is necessary to extend the guidewire 26, which is depicted in its normal outline on the outside of the body in FIG. The main portion 50 and the end portion 51 of the
Have a curved shape). The end portion 51 is composed of a first curved portion 52 and a second curved portion 53, which are separated by a relatively short linear intermediate portion 54. The curvature of the first bending portion 53 is preferably such that the intermediate portion 54 has a linear main portion 5.
An angle of about 30 ° is formed with respect to the vertical axis 55 of zero. For other uses of this guidewire, or as needed for the illustrated uses of the present invention, the curvature of the first bend is, however, varied so that its angle is in the range 10-135 °. be able to. The bending of the second bending portion 53 is such that the vertical axis 56 of the normally linear middle portion is
It is an angle of about 45 ° with respect to an assumed straight line 57 extending from the end of the second curved portion 53 (this is depicted by imagination). Similar to the first bend, the bend of the second bend can be varied such that its angle is in the range of 10-135 °. The length of the intermediate portion 54 in the depicted embodiment is 3 cm. The double curvature of the guide wire 26 allows the guide wire 26 to be guided through the contralateral iliac artery and properly enters the contralateral femoral artery 13a (see Figure 2c).

Once the guidewire 26 is properly placed in the contralateral femoral artery 13a, it is cross clamped and an arteriotomy is performed. If the guide wire 26 is completely guided into the contralateral femoral artery 13a, the guide wire 26 is retrieved simply by withdrawing the guide wire through the incision or puncture made in the artery 13a. If the guide wire 26 is not completely guided along the femoral artery 13a, a loop or similar device can be introduced through the contralateral femoral artery 13a to grasp the guide wire 26 and retrieve it. Pull back to the puncture site or incision site.
Once the guidewire 26 is withdrawn, the thin catheter 25 is then withdrawn via the ipsilateral side and the other catheter 27 then enters the first graft 17 and at least the contralateral tubular extension 19a. It is fed over the guide wire 26 through the contralateral femoral artery 13a until it reaches the upper part. The guide wire 26 is then
The rigid guidewire 30 is withdrawn and inserted into the catheter 27 through the contralateral femoral artery 13a. Catheter 27 is then removed and catheter sheath 21a and dilator are introduced over rigid guidewire 30 (see Figure 2e).

Before extending the guidewire 26 to the contralateral iliac and femoral arteries, a catheter sheath (similar to the catheter sheath 21) may be extended upstream through the contralateral femoral and iliac arteries, Reduce any meandering that may be present in these arteries, so
It facilitates guiding the guide wire 26 therethrough.

The second balloon catheter 24a (eg, as depicted in FIG. 5) has the second tubular graft 17b packaged thereon, but then at its upper end within the contralateral tubular extension 19a. Enter the iliac artery 13 at the lower end until the catheter sheath 21a
Be introduced through. The balloon 20a on the catheter 24a is inflated so that the upper end of the implant 17b is frictionally engaged with the contralateral tubular extension 19a (see Figure 2f). Inflation of balloon 20a on catheter 24a supports graft 17 while withdrawing first balloon catheter 24 through ipsilateral iliac artery 12. The balloon 20 is then deflated and the catheter 24a is maintained in position to position the graft 17, 17b in the aorta 10 while positioning the third graft.
Give continued support for.

The catheter sheath 21a is then removed (see FIGS. 2f and 2g) and the sheath 21 on the guide wire 23 is wrapped with a third balloon catheter (on which the tubular graft 17a is packaged). ) (The third balloon catheter can be the same as depicted in FIG. 5). It is advanced until its upstream end is in the ipsilateral extension 19, followed by partial withdrawal of the sheath 21 and then deployment. The third graft 17a positioned on the third balloon catheter is therefore contacted at its upstream end with the ipsilateral extension 19, the downstream end of which is the right iliac artery 1.
2 is contacted (see FIG. 2h).

The rigid guidewires 23 and 30 are now withdrawn and the contralateral incision or puncture is sutured. At this point, a second angiography study is performed, and if the graft 17
, 17a and 17b are properly installed and functioning, the hemostatic sheath 21 is withdrawn and the right femoral incision is sutured. The result is that the trouser-like implant functions to bridge the aneurysm, as depicted in Figure 2i.

This operation includes general anesthesia and epidural anesthesia.
ic, epidural anesthesia) or, where appropriate, local anesthesia alone.

An alternative guide wire to that depicted as 26 in Figure 3a is shown in Figures 3b-c.
Is depicted in. FIG. 3b depicts a resilient and flexible guidewire body 60, which has a generally straight main portion 50 and distal portion 51. Terminal 5
1 has a first curved portion 61 (which has a first circular curvature), a second curved portion 62 (which has a different circular curvature), and a curved middle portion 63 (which has an elliptic curvature). Have). FIG. 3 c depicts a resilient and flexible guidewire 70, which has a generally straight main portion 50 and a curved distal end 51, the curved distal end 51 having a first curved portion 71. (This has an assumed circular curve) and a second curved section 72 (which is continuous with the end of the first curved section 71 and has a different assumed circular curve). Guidewires having a distal end with a more curved shape are also envisioned.

Those skilled in the art will appreciate that numerous variations and / or modifications can be made to the invention illustrated in a particular embodiment without departing from the broadly described spirit and scope of the invention. To do. Embodiments of the invention are therefore considered in all respects as illustrative rather than limiting.

[Brief description of drawings]

By way of example only, a preferred embodiment of the present invention has now been described with reference to the accompanying drawings.

FIG. 1 is a simplified schematic diagram of the abdomen of a patient with an aortic aneurysm cross-linked with a trouser-like implant.

FIG. 2a shows the steps of performing the method of intraluminally placing a pant-like implant in a patient using the invention defined herein.

FIG. 2b shows the steps of performing the method of endoluminally placing a pant-like implant in a patient using the invention defined herein.

FIG. 2c illustrates performing a method of endoluminally placing a trouser implant in a patient using the invention defined herein.

FIG. 2d shows the steps of performing the method of endoluminally placing a pant-like implant in a patient using the invention defined herein.

FIG. 2e shows the steps of performing the method of endoluminally placing a trouser implant in a patient using the invention defined herein.

FIG. 2f shows the steps of performing the method of endoluminally placing a trouser implant in a patient using the invention defined herein.

FIG. 2g shows the steps of performing the method of endoluminally placing a pant-like implant in a patient using the invention defined herein.

FIG. 2h illustrates performing a method of endoluminally placing a pant-like implant in a patient using the invention defined herein.

2i shows the steps of performing the method of intraluminally placing a pant-like implant in a patient using the invention defined herein.

FIG. 3a   FIG. 3a is a side elevational view of a different embodiment of a guide wire according to the present invention.

FIG. 3b   FIG. 3b is a side elevational view of a different embodiment of a guide wire according to the present invention.

[Fig. 3c]   FIG. 3c is a side elevational view of a different embodiment of a guide wire according to the present invention.

FIG. 4 is a vertical cross-sectional view of one embodiment of a possible bifurcated implant attached to a delivery catheter for use in the method depicted in FIGS.

FIG. 5 is a vertical cross-sectional view of one embodiment of a tubular implant attached to a delivery catheter for use in the method depicted in FIGS.

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, SD, SL, SZ, TZ, UG, ZW ), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, C U, CZ, DE, DK, EE, ES, FI, GB, GD , GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, L K, LR, LS, LT, LU, LV, MD, MG, MK , MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, T M, TR, TT, UA, UG, US, UZ, VN, YU , ZA, ZW (71) Applicant Edwards Life Sciences Co             Poration             Edwards Lifescience             s Corporation             United States California 92614,               Irvine, One Edwards We             I             One Edwards Way, Ir             vine, CALIFORNIA             92614, U.S.P. S. A. (72) Inventor White, Geofree H.             Australia NSW             2041, East Balmain, Nicole             Son Street 22 (72) Inventor Yu, Wei Yun             Australia NSW             2041, Bitch Grove, Apartment             Number 59 Number 8 (72) Inventor Foster, Stu             United States California 92614,               Irvine, East Alton Par             Quay 1402 F-term (reference) 4C167 AA07 AA09 AA28 BB02 BB03                       BB07 BB26 BB27 CC10 DD01                       DD08 GG03 GG08 GG23 GG24                       GG32 GG33 GG36

Claims (6)

[Claims] 1. A directional medical guidewire, the guidewire having two ends and a luminal insertion outer surface, the guidewire comprising the following portions: Resilient and flexible An elongated body having a body that is biased to a first shape; and a distal end, the distal end being continuous with one end of the main body,
A guide wire defined by a curved shape, the curved shape having a first portion with a first curved portion and a second portion having a second curved portion different from that of the first portion. 2. A method of installing the guide wire according to claim 1, comprising:
Here, the guidewire is adapted to be hung outside the body having a lumen, whereby the distal end distal from the distal end is free depending. 3. The method of using the guidewire of claim 1, wherein the method changes the shape of the guidewire during storage by wrapping the guidewire into a spring biased state. A method; packaging the guidewire; removing the guidewire; and reconstituting the undeflected orientation of the guidewire within the lumen. 4. At least a metal and alloy selected from the group consisting of nitinol, nickel, titanium, stainless steel, elgiloy, palladium and similar superelastic or flexible, substantially metallic or magnetic combinations. The guide wire according to claim 1, comprising one kind. 5. The outer surface is coated with at least one biocompatible substance selected from the group consisting of PET, PTFE, silicone-based lubricants and similar plastic-based materials. Guide wire. 6. A kit, the kit comprising: a guide catheter having a directional medical guidewire disposed in the guide catheter;
A kit comprising: a first means for installing the guidewire; a means for adjusting the installed guidewire; and a second means for installing the guidewire.