CA2198314C - Method of producing a guide wire and guide wire - Google Patents

Method of producing a guide wire and guide wire Download PDF

Info

Publication number
CA2198314C
CA2198314C CA002198314A CA2198314A CA2198314C CA 2198314 C CA2198314 C CA 2198314C CA 002198314 A CA002198314 A CA 002198314A CA 2198314 A CA2198314 A CA 2198314A CA 2198314 C CA2198314 C CA 2198314C
Authority
CA
Canada
Prior art keywords
coil
guide wire
centring
connection location
mould
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002198314A
Other languages
French (fr)
Other versions
CA2198314A1 (en
Inventor
Jakob Willi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Schneider Europe GmbH
Original Assignee
Schneider Europe GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schneider Europe GmbH filed Critical Schneider Europe GmbH
Publication of CA2198314A1 publication Critical patent/CA2198314A1/en
Application granted granted Critical
Publication of CA2198314C publication Critical patent/CA2198314C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core

Abstract

The guide wire serves in particular for the percutaneous introduction of a balloon dilation catheter into a blood vessel and has a flexible coil (2) which surrounds a likewise flexible shaft (3) and is produced from at least two coil springs (4, 5), which are rotated together at a connection location (8) over a plurality of turns (4a, 5a) and are soldered to one another. For the purpose of connection, at the end (4b, 5b) to be connected, the two coil springs (4, 5) are each slid onto a centring mould (7), rotated together and soldered. The centring mould (7) is then removed again. The connection location (8) is tubular and internally hollow, so that the flexible shaft (3) can be inserted subsequently.

Description

MG/ep Schneider (Europe) AG
8180 Biilach Method of producing a guide wire and guide wire The invention relates to a method of producing a guide wire, in particular for the percutaneous introduction of a balloon dilation catheter into a blood vessel, which guide wire has a flexible coil which surrounds a likewise flexible shaft and is produced from at least two coil springs, which are rotated together at a connection location over a plurality of turns and are soldered to one another.
Moreover, the invention relates to a guide wire, in particular for the percutaneous introduction of a balloon dilation catheter into a blood vessel, having a flexible coil which surrounds a likewise flexible shaft and is produced from at least one distal and one proximal coil spring, which coil springs are rotated together at a connection location over a plurality of turns and are soldered to one another.
Numerous embodiments of guide wires of the said type are known in the prior art and are used, in particular, for the purcutaneous introduction of a balloon dilation catheter into a blood vessel, in particular a constriction in such a vessel. In order for the guide wire to be suitable for introducing a balloon dilation catheter into a constriction in a blood vessel, it must have, in addition to a high operational reliability, special properties, and in particular it must be controllable and very flexible at the distal end. Moreover, the guide wire should have a region which is visible to X-rays which is comparatively short and sharply defined.
A guide wire of this kind is disclosed, for example, in US-A-4, 748, 986. This guide wire has a coil ~, 2198314 ~r _ which comprises a distal coil spring which is visible to X-rays and a proximal coil spring. The coil surrounds a shaft which at the distal end is conically tapered and connected to a tip. In order to connect the two coil springs, the latter are rotated together at the ends to be connected over a plurality of turns and are soldered continuously to the shaft and a safety strip. This joining of the coil springs and the soldering represent an extremely complex and, in particular, time-intensive manual operation. Due to the comparatively solid solder region, the guide wire is significantly less flexible at the connection location than in front of and behind this region. As a result, the controllablility of the guide wire is impaired. In order to improve the desired properties of the guide wire, it has been proposed in EP-A-0,625,358 to connect the two coil springs by means of a connection coil.
After stretching the turns to be connected and inserting the flexible shaft, this comparatively short connection coil is rotated in and soldered. This has the effect, inter alia, that the flexibility of the guide wire is impaired to a lesser extent by the connection location. However, the time required to connect the two coil springs is comparatively high, it being necessary to take into account the extreme fineness of the coil springs to be connected and the high demands placed on the reliability of the connection location.
EP-A-0,419,277 shows a further possibility for connecting two coil springs. This method uses an intermediate piece which has grooves on the outside, onto which grooves the coil-spring ends to be connected are rotated.
The invention is based on the object of providing a method and a guide wire of the said generic types which permit more rapid production and yet meet the high demands with regard to safety.
The method according to the invention is characterized in that, at the end to be connected, the ).
~- - 3 - 2198314 two coil springs are each slid onto a centring mould, rotated together and soldered, and in that the centring mould is then removed again. In the method according to the invention, it is no longer necessary to rotate in the extremely fine connection coil, yet a connection location which is tubular and is comparable to the other regions of the guide wire, particularly with regard to flexibility, is nevertheless provided. The centring mould forms a template which significantly facilitates rotating the two coil springs together and thus makes it possible to work more rapidly but nevertheless reliably. The two coil springs which have been rotated together are aligned with respect to one another by the centring mould and can be soldered simply but precisely. The centring mould prevents the solder from being able to penetrate into the interior of the coil, so that the connection location is smooth and internally hollow following removal of the centring mould. As a result, the coil-spring unit can be preassembled and only put on the flexible shaft in a subsequent operation. Preassembled coil-spring units can thus be kept in stock, which significantly facilitates the organization of assembly.

In accordance with a refinement of the invention, the centring mould is designed such that it does not take to the solder during the soldering of the coil springs and does not become joined thereto. Such a centring mould is preferably made from a suitable titanium alloy, for example from Tynel or NiTi alloy.

Such a centring mould is very flexible and it has proven extremely suitable for producing such a connection. Since the solder does not become joined to the centring mould and is flexible, it can be removed following soldering in a very simple and gentle manner.

The guide wire according to invention is characterized in that the connection location is designed to be tubular and, with the exception of the said shaft, internally hollow. This guide wire is preferably produced in accordance with the abovementioned method. It has the particular advantage that, in the region of the connection location, it has largely similar properties to the areas in front of and behind this location. Preferably, the solder is applied such that it does not, or does not significantly, project beyond the outside and the inside of the coil in the region of the connection location. It is thus scarcely possible to distinguish the region of the connection location from the other regions with regard to most properties of the guide wire.
In accordance with one aspect there is provided method of producing a guide wire, which guide wire has a flexible coil which surrounds a likewise flexible shaft and is produced from at least two coil springs, which are rotated together at a connection location over a plurality of turns and are soldered to one another, characterized in that, at the end to be connected, the two coil springs are each slid onto a centring mould, rotated together and soldered, and in that the centring mould is then removed again.
In accordance with a further aspect there is provided guide wire, with a flexible coil which surrounds a likewise flexible shaft and has at least one distal and one proximal coil spring, which coil springs are soldered together over several turns at a connection location, wherein the coil is designed to be tubular at the connection location and, with the exception of the said shaft, internally hollow, wherein the coil springs are twisted together into each other over several turns at the connection location, wherein the coil is designed to be continuous and steplessly tubular at the connection location.

- 4a -Further advantageous features emerge from the dependent patent claims, the description below and the drawing.
Exemplary embodiments of the invention are explained in more detail below with reference to the drawing, in which:
Figure 1 diagrammatically shows how two coil springs are rotated together, Figure 2 diagrammatically shows two coil-spring ends which have been rotated together, Figure 3 diagrammatically shows two coil-spring ends which have been rotated together and soldered, Figure 4 diagrammatically shows a section of a guide wire according to the invention, and Figure 5 diagrammatically shows a section of a guide wire in accordance with a variant.
Figure 4 shows a section of a guide wire 1 which, with the exception of the connection location 8 shown here, may correspond exactly to that of the abovementioned EP-A-0,625,358. This document is referred to here for the disclosure. In Figure 4, the distal end (not shown here) is on the right and the proximal end is on the left. The guide wire 1 has a flexible shaft 3, which at the distal end (not shown here) is tapered and flattened and is fixedly connected to the tip (likewise not shown here). The shaft 3 forms a core wire and is surrounded over its entire length by a likewise flexible coil 2, which has a proximal coil spring 4 and a distal coil spring 5, which are firmly connected to one another at a connection location 8.
The coil 4 preferably consists of a rustproof wire having a diameter of, for example, about 0.06 mm. The external diameter C (Figure 2) of this coil spring 4 is preferably about 0.31 - 0.32 mm. The distal coil spring 5 is made from a material which is visible to X-rays, for example tungsten, and has an external diameter D of preferably about 0.31 mm. The coil spring 5 is wound from a wire which has a diameter of, for example, about 0 . 05 mm.
The connection of the two coil springs 4 and 5 is explained in more detail below with reference to Figures 1 to 3.
In order to connect the two coil springs 4 and 5 firmly to one another, a few turns, preferably 2 to 5 turns 4a and 5a, are opened up and rotated together at the ends to be connected. In this process, the two coil springs 4 and 5 are preferably pulled onto a centring mould 7 which forms a centring mould. The external diameter A of the centring mould 7 is equal to or slightly less than the internal diameter B of the coil springs 4 and 5. As a result of the guidance of the centring mould, the spirals cannot drift to the side when being rotated together.
Figure 2 shows the two coil springs 4 and 5 after the extended turns 4a and 5a have been rotated together. In accordance with Figure 3, solder 6 is now applied around these turns 4a and 5a. This solder penetrates into the gaps between these turns 4a and 5a and encloses the centring mould 7 on its smooth and cylindrical outside 7a in the region of the said turns 4a and 5a. This centring mould 7 is now preferably designed such that it does not take to the solder used and also does not become joined thereto. Preferably, the centring mould consists of a nickel-titanium alloy, for example Tynel or NiTi alloy. However, it is also possible to use other suitable alloys of tungsten of molybdenum. These alloys do not take to the solder 6 and produce a flexible wire and tube piece 7. After soldering, the centring mould 7 can be pulled out of the coil 2 in a very simple manner without damaging the connection location 8. The two coil springs 4 and 5 are now firmly connected to one another at the connection location 8. The inside 6d of the connection location 8 is smooth and cylindrical, specifically in a manner corresponding to the outside 7a of the centring moulds 7. The connection location 8 is likewise cylindrical and essentially does not proj ect beyond the outside of the coil 2.

After the centring mould 7 has been removed, the shaft 3 is inserted into the coil 2 and connected to the tip in a known manner. It is significant that the introduction of the shaft 3 is not impeded by the connection location 8, since the latter is of the same width on the inside as the coil 2 in front of and behind this region. The coil 2 can thus be preassembled without the shaft 3 and be kept in stock.

As mentioned above, the distal coil spring 5 is wound from a wire which has a smaller diameter than that of the proximal coil spring 4, as can also be seen from the drawing. In a development of the invention illustrated in Figure 5, the diameter D' of the distal coil spring 5 is selected to be as large as possible but still such that the outside of the coil spring 5, in the position offset to the side shown here, cannot protrude on the outside, which produces an outside of optimal smoothness in the region of the connection location.

Claims (15)

CLAIMS:
1. Method of producing a guide wire, which guide wire has a flexible coil which surrounds a likewise flexible shaft and is produced from at least two coil springs, which are rotated together at a connection location over a plurality of turns and are soldered to one another, characterized in that, at the end to be connected, the two coil springs are each slid onto a centring mould, rotated together and soldered, and in that the centring mould is then removed again.
2. The method of Claim 1 wherein said guide wire is for the percutaneous introduction of a balloon dilation catheter into a blood vessel.
3. Method according to Claim 1 or 2, wherein the centring mould is designed such that it does not take to the solder during the soldering of the coil springs and does not become joined thereto.
4. Method according to any one of Claims 1 to 3, wherein the centring mould consists of a titanium alloy.
5. The method of Claim 4 wherein the titanium alloy is a nickel titanium alloy.
6. Method according to Claim 4 or 5, wherein the alloy is Tynel.
7. Method according to any one of Claims 1 to 6, wherein the centring mould has an external diameter which is essentially equal to the internal diameter of at least one of the coil springs.
8. Method according to any one of Claims 1 to 7, wherein the turns to be connected are opened up before being rotated together.
9. Method according to any one of Claims 1 to 8, wherein the flexible coil comprises a distal coil spring and a proximal coil spring, wherein the distal coil spring is made from a material which is visible to X-rays and the proximal coil spring is made from a material which is essentially invisible to X-rays.
10. The method according to Claim 9 wherein the distal coil spring is made from tungsten.
11. The method according to Claim 9 or 10, wherein the proximal coil spring is made from stainless steel.
12. Guide wire, with a flexible coil which surrounds a likewise flexible shaft and has at least one distal and one proximal coil spring, which coil springs are soldered together over several turns at a connection location, wherein the coil is designed to be tubular at the connection location and, with the exception of the said shaft, internally hollow, wherein the coil springs are twisted together into each other over several turns at the connection location, wherein the coil is designed to be continuous and steplessly tubular at the connection location.
13. The guide wire of Claim 12 wherein said guide wire is for the percutaneous introduction of a balloon dilation catheter into a blood vessel.
14. Guide wire according to Claim 12 or 13, wherein the solder does not, or does not significantly, project beyond the outside and the inside of the coil in the region of the connection location.
15. Guide wire according to any one of Claims 12 to 14, wherein the distal spiral spring is produced from a wire which has a smaller diameter than the wire from which the proximal coil spring is produced.
CA002198314A 1996-05-03 1997-02-24 Method of producing a guide wire and guide wire Expired - Fee Related CA2198314C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP96106958.0 1996-05-03
EP96106958A EP0804937B1 (en) 1996-05-03 1996-05-03 Guidewire and its manufacturing procedure

Publications (2)

Publication Number Publication Date
CA2198314A1 CA2198314A1 (en) 1997-11-04
CA2198314C true CA2198314C (en) 2007-03-06

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA002198314A Expired - Fee Related CA2198314C (en) 1996-05-03 1997-02-24 Method of producing a guide wire and guide wire

Country Status (9)

Country Link
US (1) US5951496A (en)
EP (1) EP0804937B1 (en)
JP (2) JP3875762B2 (en)
AT (1) ATE164772T1 (en)
AU (1) AU1787197A (en)
CA (1) CA2198314C (en)
DE (1) DE59600146D1 (en)
DK (1) DK0804937T3 (en)
ES (1) ES2116798T3 (en)

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Also Published As

Publication number Publication date
JP2006297152A (en) 2006-11-02
DK0804937T3 (en) 1999-01-11
ATE164772T1 (en) 1998-04-15
EP0804937A1 (en) 1997-11-05
ES2116798T3 (en) 1998-07-16
DE59600146D1 (en) 1998-05-14
AU1787197A (en) 1997-11-06
EP0804937B1 (en) 1998-04-08
US5951496A (en) 1999-09-14
JP3875762B2 (en) 2007-01-31
CA2198314A1 (en) 1997-11-04
JPH1043307A (en) 1998-02-17

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