CA2188199C - Guidewire assembly - Google Patents

Guidewire assembly Download PDF

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Publication number
CA2188199C
CA2188199C CA002188199A CA2188199A CA2188199C CA 2188199 C CA2188199 C CA 2188199C CA 002188199 A CA002188199 A CA 002188199A CA 2188199 A CA2188199 A CA 2188199A CA 2188199 C CA2188199 C CA 2188199C
Authority
CA
Canada
Prior art keywords
proximal
end coils
coils
wire
core wire
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 - Lifetime
Application number
CA002188199A
Other languages
French (fr)
Other versions
CA2188199A1 (en
Inventor
Robert Frechette
William R. Dorcas, Jr.
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.)
Cordis Corp
Original Assignee
Cordis Corp
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 Cordis Corp filed Critical Cordis Corp
Publication of CA2188199A1 publication Critical patent/CA2188199A1/en
Application granted granted Critical
Publication of CA2188199C publication Critical patent/CA2188199C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61M2025/09091Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • 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
    • A61M2025/09166Guide wires having radio-opaque features
    • 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
    • A61M2025/09175Guide wires having specific characteristics at the distal tip

Abstract

The guidewire assembly includes a distal tip section comprising a core wire, a mushroom shaped head fixed to a distal end of the core wire, and a coiled radiopaque wire having a distal end portion fused to the head and a proximal necked down portion which necks down to proximal end coils forming a proximal end of the coiled radiopaque wire. The proximal end coils are received on a portion of the core wire and fixed thereto by a flexible material. The method for making a guidewire assembly having increased flexibility and a secure connection between a coiled wire and a core wire comprises the steps of: forming a coiled radiopaque wire with a larger-in-diameter distal portion, a necked down middle portion, and a smaller-in-diameter proximal portion having a plurality of end coils; winding the end coils on a mandrel,so that the end coils can form the proximal end portion of the coiled wire; pushing the end coils onto a tapered portion of a core wire; placing a flexible sleeve over the end coils; heat shrinking the flexible sleeve at one temperature; placing an outer sleeve over the flexible sleeve; and, heat shrinking the outer sleeve at a higher temperature to melt the flexible sleeve causing it to bond onto the tapered portion between the end coils and to the end coils.

Description

GUIDEWIRE ASSIICBLY
BACKGROUND OF TSE INVENTION
1. Field of the Invention.
The present invention relates to a guidewire assembly for enhancing, in a tip section of the guidewire, the connection of a necked down proximal end portion of a coiled wire to a tapered portion of a core portion of a guidewire utilizing a nylon fusing sleeve for fusing the proximal end portion of the coiled wire to the tapered portion.
2. Background to the Invention.
Heretofore various techniques have been proposed for securing a tapered portion of a core wire of a guidewire assembly to a coiled wire to ensure that if the core wire breaks, the broken segment does not separate from the remaining core wire and yet retains flexibility in a tip section of a guidewire.
Several techniques have been proposed for the construction of a tip section of a guidewire and examples of some of those techniques and constructions are disclosed in the following U.S. and foreign patents:
U.S. Patent No. Patentee Re.33,911 Samson et al.
4,538,622 Samson et al.
4,732,163 Bonello et al.
4,748,986 Morrison et al.
4,763,647 Gambale et al.
4,832,047 Sepetka et al.
4,940,062 Hampton et al.
5,174,302 Palmer 5,228,453 Sepetka et al.
5,267,574 Viera et al.
5,345,945 Hodgson et al.
5,353,808 Viera 5,402,799 Colon et al.
5,409,015 Palermo et al.
Foreign Publications:
EP 0 142 330 Samson et al.

The Gambale et al. U.S. Patent No. 4,922,924 discloses a distal brazed joint between a coil and a core wire or shaft and a proximal adhesive joint between the coil and a larger-in-diameter portion of the shaft.

~i88199 The Viera et al. U.S. Patent No. 5,267,574 discloses a necked down portion of a coiled wire and proximal end coils of the necked down coiled wire held to a distal end of a core wire by a polytetrafluorethylene sleeve heat shrunk around the proximal end coils.
The Viera U.S. Patent No. 5,353,808 shows a solder connection between coils of a coiled wire and a tapered portion of a core wire in a guidewire assembly.
The Morrison et al. U.S. Patent No. 4,748,986 shows a brazed connection between a coil and a tapered portion of a flexible elongate element (core wire) of a guidewire assembly.
The Sepetka et al. U.S. Patent No. 4,832,047 teaches fixing of flattened coils at the proximal end of a coil to a tapered distal end portion of a core wire by a soldered.or welded connection to the core wire.
The Palermo et al. U.S. Patent No. 5,409,015 teaches a soldered joint between an outer fine wire coil and a distal tapered portion of a metal guidewire core.
As will be described in greater detail hereinafter, the guidewire assembly of the present invention provides a flexible attachment and method for attaching a necked down proximal end portion of a radiopaque platinum tungsten coiled wire to a tapered portion of a stainless steel core wire using a heat shrinkable and meltable plastic sleeve.
StJN+tARY OF THE INVENTION
According to the teachings of the present invention there is provided a guidewire assembly including a distal tip section including a core wire, a mushroom shaped head fixed to a distal end of the core wire, and a coiled radiopaque wire having a distal end portion fused to the head and a proximal necked down portion which necks down to proximal end coils forming a proximal end of the coiled radiopaque wire. The proximal end coils are received on a portion of the core wire and fixed thereto by a flexible material which extends into the space between the proximal end coils.
Further according to the present invention there is provided a method for making an enhanced guidewire assembly having increased flexibility and a secure connection between a coiled wire and a core wire comprising the steps of: forming a coiled radiopaque wire with a larger-in-diameter distal portion, a necked down middle portion, and a smaller-in-diameter proximal portion having a plurality of proximal end coils; winding the end coils on a mandrel so that the end coils can form the proximal end portion of the coiled wire; pushing the proximal end coils onto a tapered portion of a core wire;
placing a flexible sleeve over the flattened end coils; heat shrinking the flexible sleeve at one temperature; placing an outer sleeve over the flexible sleeve; and, heat shrinking the outer sleeve at a higher temperature to melt the flexible sleeve causing it to bond onto the tapered portion between the end coils and to the end coils.

C 'i 88 l 99 BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a longitudinal sectional view through the tip section of the guidewire assembly constructed according to the teachings of the present invention.
FIG. 2 is a fragmentary sectional view of the proximal end of the necked down coiled wire shown in FIG. 1 after the proximal end coils have been flattened and then wound on a mandrel.
FIG. 3 is a fragmentary, sectional view of a second tapered portion of the core wire, shows the flattened coils pushed onto the second tapered portion of the core wire of the guidewire, shows a nylon sleeve heat shrunk over the flattened coils and -shows a polytetrafluorethylene (TeflonTM) sleeve placed thereover prior to heat shrinking.
FIG. 4 is a fragmentary, sectional view of the second tapered portion of the core wire, shows the flattened end coils on the second tapered portion of the core wire of the guidewire and shows the polytetrafluorethylene (PTFE) sleeve heat shrunk over the nylon sleeve heat causing it to melt and form a glue or adhesive between the PTFE sleeve, the flattened end coils and the second tapered portion of the core wire of the guidewire assembly.

DESCRIPTION OF THE PREFERRED EMBODIMENT(S) Referring now to the drawings in greater detail, there is illustrated in FIG. 1 a longitudinal sectional view of a tip section 10 of a guidewire assembly 12 constructed according to 5 the teachings of the present invention. The guidewire assembly 12 includes a stainless steel core wire 14 comprising a proximal first uniform diameter portion 16, a middle larger-in-diameter portion 18 coated . with a layer 19 of polytetrafluorethylene, a necked down portion 20, a first reduced-in-diameter portion 22, a first tapered portion 24, a second reduced-in-diameter portion 26 having a diameter similar to the first proximal portion 16, a second tapered portion 28, and a rod tip portion 30 which can have a nub or cylinder 32 and which extends to a mushroom shaped tip 34. Fixed or fused to a back side 36 of the mushroom shaped tip 34 is a distal coil 38 of a coiled platinum or platinum tungsten (92a platinum and 81 tungsten) wire 40 that has a diameter of approximately 0.003 inch and that includes a coiled distal portion 42 with a uniform diameter extending proximally to a necked down portion 44 that extends downwardly to a proximal portion 46 including reduced-in-diameter proximal end coils 46.
According to the teachings of the present invention the proximal end coils 46 are flattened, stretched out and then wound on a mandrel 48, shown in FIG. 2. Then the proximal end coils 46 are pushed over the second tapered portion 28, as shown in FIG. 3 to establish an interference fit between the end coils 46 and the second tapered portion 28, thereby to firmly hold the end coils 46 to the core wire 14. On the second tapered end portion 28, the turns or end coils 46 are spaced apart a distance W of between approximately 0.010 to 0.015 inch and preferably only 0.010 inch.
Then, according to the teachings of the present invention and as shown in FIG. 3, a nylon sleeve 50 is heat shrunk over the end coils 46 on the. second tapered portion 28, at a temperature of approximately 350 F, thereby to extend between the end coils 46 and to the second tapered portion 28 of the core wire 14. Next, a sleeve 54 of polytetrafluorethylene-PTFE
(Teflon'm) is placed over a proximal end 56 of the rod tip portion 30, the second tapered portion 28, the second reduced-in-diameter portion 26, the first tapered portion 24 and the first reduced-in-diameter portion 22 and heat shrunk, as shown in FIG. 1 and in FIG. 4 at a temperature of approximately 700 F, above the melting point of 400 F for nylon, and, in the process, melting the nylon sleeve 50 to a glue 58 causing it to flow between the stretched out, spaced apart, flattened end coils 46 like a glue or adhesive 58 and adhere to the flattened end coils 46 and to the second tapered portion 28, thereby to fix the end coils 46 to the core wire 14.
While the nylon sleeve 50 is preferred, sleeves of other " materials, such as polyurethane and polyvinylchloride (PVC) could be utilized. The material is preferably a heat shrinkable thermoplastic material.
The mushroom shaped tip 34 is formed by a fusing or melting of distal coils of the coiled platinum wire 40 to the nub or cylinder 32 at the outer end of the stainless steel rod tip portion 30 so as to form the mushroom tip 34 with a stem 60 slightly larger in diameter than the proximal end 56 of the rod tip portion 30 and a mushroom shaped head 62 made cf fused platinum and stainless steel. The distal coils are spaced apart a distance L of approximately 0.001 inch.
The fixing of the flattened end coils 46 with the melted nylon, which serves as a hot glue 58, to the second tapered portion 28 has the advantage of maintaining flexibility and pliability in the connection of the flattened end coils 46 to the second tapered portion 28 and avoid the stiffness obtained when such end coils are brazed, welded or soldered to a core wire.
From the foregoing description, it will be appreciated that the guidewire assembly 12, and particularly the tip section 10 thereof, has a number of advantages, some of which have been described above and other of which are inherent in the invention. Accordingly, the scope of the invention is only to be limited as necessitated by the accompanying claims.

Claims (20)

1. A guidewire assembly including a distal tip section including a core wire having a distal end, a head connected to said distal end of the core wire, said core wire extending from said distal end to a first proximal portion which extends to a second main body proximal portion, and a coiled radiopaque wire having a distal end portion fixed to said head and a proximal necked down portion which necks down to proximal end coils forming a proximal end of the coiled radiopaque wire, said proximal end coils being received on said first proximal portion of said core wire; a short sleeve of thermoplastic material received over said proximal end coils received on said first proximal portion and melted over and between said proximal end coil for fixing same onto said first proximal portion of said core wire; a sleeve of heat shrinkable material received over said proximal end coils and said first proximal portion and said proximal main body portion and heat shrunk over at least said first proximal portion to cause melting of said short sleeve of thermoplastic material into the spaces between coils of said proximal end coils.
2. The guidewire assembly of claim 1 wherein said proximal end coils are flattened.
3. The guidewire assembly of claim 1 wherein said first proximal portion of said core wire is tapered from said second proximal main body portion which has a larger diameter to a distal smaller diameter portion.
4. The guidewire assembly of claim 1 wherein said short sleeve is made of nylon.
5. The guidewire assembly of claim 1 wherein said melted material of said short sleeve extends into the space between proximal end coils and to said first proximal portion of said core wire and is adhered thereto.
6. The guidewire assembly of claim 1 wherein said end coils are spaced apart approximately 0.01 to 0.015 inch.
7. The guidewire assembly of claim 1 wherein said end coils are spaced apart no more than 0.01 inch.
8. The guidewire assembly of claim 1 wherein said coils in said distal end portion of said coiled radiopaque wire are spaced apart approximately 0.001 inch.
9. The guidewire assembly of claim 1 wherein said coiled radiopaque wire has a diameter of approximately 0.003 inch.
10. A method for making a guidewire assembly having increased flexibility and a secure connection between a coiled wire and a core wire comprising the steps of:
forming a coiled radiopaque wire with a larger-in-diameter distal portion, a necked down middle portion, and a smaller-in-diameter proximal portion having a plurality of end coils; winding the end coils on a mandrel so that the end coils can form the proximal end portion of the coiled wire; pushing the end coils onto a tapered portion of a core wire; placing a flexible sleeve over the end coils; heat shrinking the flexible sleeve at one temperature; placing an outer sleeve over the flexible sleeve;
and, heat shrinking the outer sleeve at a higher temperature to melt the flexible sleeve causing it to melt and bond onto the tapered portion between the end coils and to the end coils.
11. The method of claim 11 wherein said flexible sleeve is made of nylon.
12. The method of claim 11 wherein said coiled radiopaque wire is made of platinum.
13. The method of claim 11 wherein said outer sleeve is made of polytetrafluorethylene.
14. The method of claim 11 wherein said flexible sleeve is heat shrunk at a temperature of approximately 350°F.
15. The method of claim 11 wherein said outer sleeve is heat shrunk at a temperature of at least 700°F.
16. The method of claim 11 wherein said end coils are spaced apart approximately 0.01 to 0.015 inch.
17. The method of claim 11 wherein said end coils are spaced apart no more than 0.01 inch.
18. The method of claim 11 wherein coils in said distal end portion of said coiled radiopaque wire are spaced apart approximately 0.001 inch.
19. The method of claim 11 wherein said coiled radiopaque wire has a diameter of approximately 0.003 inch.
20. The method of claim 11 wherein said end coils are first flattened before being wound on the mandrel.
CA002188199A 1995-10-27 1996-10-18 Guidewire assembly Expired - Lifetime CA2188199C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/549,157 US5830155A (en) 1995-10-27 1995-10-27 Guidewire assembly
US08/549,157 1995-10-27

Publications (2)

Publication Number Publication Date
CA2188199A1 CA2188199A1 (en) 1997-04-28
CA2188199C true CA2188199C (en) 2007-09-04

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA002188199A Expired - Lifetime CA2188199C (en) 1995-10-27 1996-10-18 Guidewire assembly

Country Status (5)

Country Link
US (1) US5830155A (en)
EP (1) EP0770404B1 (en)
CA (1) CA2188199C (en)
DE (1) DE69619188T2 (en)
ES (1) ES2174032T3 (en)

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Also Published As

Publication number Publication date
CA2188199A1 (en) 1997-04-28
EP0770404A1 (en) 1997-05-02
ES2174032T3 (en) 2002-11-01
EP0770404B1 (en) 2002-02-13
DE69619188T2 (en) 2002-07-18
DE69619188D1 (en) 2002-03-21
US5830155A (en) 1998-11-03

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