CA2115198A1 - Guidewire with round forming wire - Google Patents

Guidewire with round forming wire

Info

Publication number
CA2115198A1
CA2115198A1 CA002115198A CA2115198A CA2115198A1 CA 2115198 A1 CA2115198 A1 CA 2115198A1 CA 002115198 A CA002115198 A CA 002115198A CA 2115198 A CA2115198 A CA 2115198A CA 2115198 A1 CA2115198 A1 CA 2115198A1
Authority
CA
Canada
Prior art keywords
guidewire
helical coil
accordance
core wire
fixedly attached
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.)
Abandoned
Application number
CA002115198A
Other languages
French (fr)
Inventor
William A. Berthiaume
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.)
CR Bard Inc
Original Assignee
William A. Berthiaume
C.R. Bard, Inc.
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 William A. Berthiaume, C.R. Bard, Inc. filed Critical William A. Berthiaume
Publication of CA2115198A1 publication Critical patent/CA2115198A1/en
Abandoned 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
    • 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

ABSTRACT
A guidewire including a core wire extending into a lumen of a helical coil and having a proximal end of the helical coil fixedly attached thereto. At least one round forming wire is fixedly attached to a distal region of the core wire and extends through the lumen of the helical coil. A rounded protrusion is provided at a distal end of the helical coil with the round forming wire(s) and the helical coil fixedly attached thereto.

Description

~1151~8 ` 2 6 GUIDEWIRE WITH ROUND FORMING WIRE ;~

BACKGROUND OF THE INVENTION
This invention relates to guidewires used in the 9 placement of catheters in cardiovascular surgical procedures.
More particularly, this invention relates to improvements in 11 small diameter steerable guidewires.
j 12 A wide variety of guidewires are used for various 13 medical purposes in the treatment of the human body. Among the 14 more common uses is in blood vessels to guide a catheter to a ~ 15 site within the patient's blood vessel to perform the procedure 3 16 for which the catheter is adapted. For example, guidewires, 17 particularly small diameter steerable guidewires, perform an 18 important function in percutanious translumenal coronary 19 angioplasty ("PTCA").
Ideally, a guidewire should exhibit the following ¦ -21 characteristics:
22 (1) a strong yet flexible tip;
(2) an easily formable tip, although not so formable 24 that the guidewire takes a permanent set when the wire is bent over on itself during use in the body; and 26 (3) a tip that exhibits 1:1 tip torque response with 27 no whipping. ;
28 Illustrative of such guidewires are those described in 29 U.S. Patent No. 4,545,390 to Leary and U.S. Patent No. 4,538,622 to Samson et al. Each of the guidewires described in those ;
31 patents has a tortionally rigid longitudinally flexible shaft and . ;:

~ - 2 -''~., :~;.,, ~ a flexible distal end that includes a radiopaque coil so that the -; 2 physician can monitor fluoroscopically the position and advancement of the guidewire in the patient's blood vessel.
Many such existing guidewires provide a strong, flexible and formable tip. However, due to a non-symmetrical tip design including a flattened safety wire, such guidewires do not transmit torque 1:1. Where a guidewire does not provide 1:1 tip torque response, torsional energy is stored in the guidewire. At .:- 9 some point during arterial insertion the energy may be released causin~ the guidewire tip to "whip" or move in an unpredictable 11 and uncontrolled manner. For a physician attempting to insert a 12 guidewire in a tortuous anatomy, such unpredictable and 13 uncGntrolled behavior is unacceptable.
14 Accordingly, there is a need for a guidewire with a strong flexible tip that exhibits 1:1 tip torque response with no 16 whipping.

18 With the foregoing in mind, it is an object of the invention to provide a guidewire that provides 1:1 tip torque response.
21 It is a further object of the invention to provide a :1 22 guidewire with a strong ~et flexible tip that exhibits no 23 whipping.
24 The Guidewire With Rounded Forming Wire in accordance with the instant invention includes a helical coil and a core 26 wire. The core wire extends into a lumen of the helical coll and 27 has a proximal end of the helical coil fixedly attached thereto.
28 The helical coil is secured at its proximal end and at a point 29 along its length to the core wire by conventional brazed joints.
At least one round forming wire is ~ixedly attached to a distal ' - 3 -I ~ region f the core wire and extends through the lumen of th~ ~
,,~ helical coil. A rounded protrusion is provided at a distal end , of the helical coil with the forming wire(s) and the helical coil 4 fixedly attached thereto.
BRIEF DESCRIPTION OF THE DRAWINGS
:l 6 The accompanying drawings, referred to herein and constituting a part hereof, illustrate preferred embodiments of the invention and, together with the description, serve to ' ~; explain the principles of the invention, wherein:
Fig. 1 is a fragmented, sectional view of a guidewire 11 in accordance with the invention;
' 12 Fig. 2 is a detailed view of the distal end of the 13 guidewire of Fig. 1;
~ 14 Fig. 3 is a fragmented, secti~nal view of a first -r~ 15 alternative embodiment of a guidewire in accordance with the 16 invention;
17 Fig. 4 is a detailed view of the distal end of the', 18 guidewire of Fiq. 3;
19 Fig. 5 is a fragmented, sectional view of a second ¦
''' 20 alternative embodiment of a guidewire in accordance with the 21 invention;
~;' 22 Flg. 6 is a detailed view of the distal end of the guidewire of Fig. 5;
, 24 Fig. 7 is a fragmented, sectional view of a third "'' alternative embodiment of a guidewire in accordance with the, Z 26 , invention; and '~ 27 Fig. 8 is a detailed view of the distal end of the 28 guidewire of Fig. 7.
29 , , 30 :~:

. - 4 -~g¢ .
DETAILED DESCRIPTION OF THE D~AWINGS
;: As shown in Fig. 1, the Guidewire With Round Forming Wire in accordance with the invention has a core wire 10 which is, e.g., a standard 0.0115 inch diameter LumisilkT~ core wire as is used in guidewire products from C.R. Bard, Inc. The core wire is typically 49.011 inches (173.5 cm) in length and made of 304V
stainless steel.
The proximal region of core wire 10- includes larger 9 diameter segment 12, approximately 0.0115 inches in diameter-and 38.136 inches (135 cm) in length. The distal region of core 11 wire 10 includes reduced diameter segment 14 which is 12 approximately 10.876 inches (38.5 cm) in length and includes a 13 first tapered portion 16 which is 2.825 inches (10 cm) in length 14 and a primary barrel 18 which is 6.921 inches (24.5 cm) in length and 0.0057 inches in diameter followed by a second tapered 16 portion 20 which is 0.989 inches (3.5 cm) in length and a distal 17 barrel 22 which is 0.141 inches (0.5 cm) in length and 0.0019 18 inches in diameter.
~' A wound helical coil 24 which is 8.531 inches (30.2 cm) ,- 20 in length and 0.0114 inches in outside diameter and made from 21 0.0022 inch diameter 304 stainless steel wire is secured to the :; 22 second tapered portion 20 of the core wire. The distal 0.565 `, 23 inches (2 cm) of the helical coil may be plated with 230 micro 24 inch gold to make the distal end of the guidewire radiopaque so that the physician can monitor fluoroscopically the position and 26 advancement of the guidewire in the patient's blood vessel.
27 Alternatively, the helical coil itself may be made of a 28 radiopaque material, e.g., platinum/tungsten, gold/platinum, or 29 gold/stainless steel. It may be appreciated that helical coil 24 s', :
,~

;:

y~
. - 5 -.,~,,,.
~, ,si .
~. . .

1 -has an outer dimension approximately equal to the outer dimension "~ 2 of larger diameter segment 12 of core wire 10.
The helical coil 24 abuts and is secured to the first 4 tapered portion 16 of core wire 10 at the proximal end of helical coil 24 by a first conventional brazed joint 26 and at a point along the length of the helical coil to core wire lo by a second 7 conventional brazed joint 28 at a point approximately 0.480 ~-inches (1.7 cm) from the end of distal barrel 22. It will be :~ appreciated that the helical coil may also be secured to the core wire by welding, soldering, or in such other appropriate manner as is known in the art.
12 The helical coil 24 includes two sections: proximal to ~,7 13 the secsnd conventional brazed joint 28 is a stacked-coil section 14 30 which is 7.486 inches in length (26.5 cm) and 0.0104 inches in diameter and, distal to the second conventional brazed joint 28, 16 an extended coil section 32 which is 1.045 inches in length (3.7 17 cm) and 0.0114 inches in diameter. The coil separation in the 18 extended coil section begins approximately 0.339 inches (1.2 cm) ~, 19 distal of the second conventional brazed joint 28 and extends to i`~ 20 the guidewire tip. The length of ten coils including separ~tions `~ 21 is 0.032-0.037 inches.
i It may be appreciated from Fig. 2 that distal barrel 22 ~;j 23 of core wire 10 ends proximally of the end of helical coil 24.
`l 24 The core wire ends approximately 0.565 inches (2 cm3 from the distal end of the helical coil. One to four round forming wires 26 . 34, 1.695 inches (6 cm) in length and 0.0015 inches in diameter, 27 are brazed to core wire 10 by capturing the forming wires in the 28 second conventional brazed joint 2~, allowing at least 0.056 ~ 29 inches (2 mm) of forming wire to extend proximal to the second ,, 30 conventional brazed joint 28. The forming wires 34 are `'': 1.

1 preferably a 304V HiTen stainless steel. Although a single ~, forming wire may be used, a symmetrical tip arrangement is preferable maklng two or more forming wires symmetrically arranged around the reduced diameter segment 14 of core wire 10 desirable.
The distal ends of helical coil 24 and forming wires 34 7 are secured to a rounded protrusion 36 formed at the end of the 8 guidewire. The rounded protrusion may be formed by various 9 methods as are know in the art including melting the distal ends of the helical coil and forming wires by the use of a welder as 11 disclosed in U.S. Patent No. 4,811,743 to Stevens.
12 The guidewire suxface may be covered with a protective - 13 lubricious coating prior to use. One such coating includes a urethane dispersion, a siloxane dispersion, polyfunctional aziridine and distilled water as disclosed in U.S. Patent No.
16 5,026,607 to Klezulas.
17 In Figs. 3 and 4 are shown a first alternative 18 embodiment of the guidewire in accordance with the invention wherein similar reference numerals are applied to similar ~`` `features. In this embodiment, an inner coil 38 is provided:to 21 increase the radiopacity of the guidewire tip as an aid to 22 fluoroscopic monitoring of the guidewire in use.
23 A helically wound inner coil 38 is provided which is 24 formed of 0.0025 inch diameter Au-Pt wire. The proximal end of the inner coil 38, positioned within helical coil 24, is secured 26 to reduced diameter segment 14 of core wire 10 by a third 27 conventional brazed joint 40 and the distal end of the inner coil ` 28 38 is secured along with the distal end of helical coil 24 and A~ 29 forming wires 34 to rounded protrusion 36 positioned at the end ~ 30 of the guidewire.

~ ~ L ~

~. . '',.

1 - It may be appreciated from Fig. 4 that the forming ! 2 wires 34 may be secured to the reduced diameter segment 14 of .~j core wire 10 by both second conventional brazed joint 28 and ~- 4 third conventional brazed joint 40. Including the forming wires in both brazed joints during the manufacturing process insures a solid connection of the forming wires to the core wire.
In Figs. 5 and 6 is shown a second alternative ~ embodiment of the guidewire in accordance with the invention .r~S wherein similar reference numerals are again applied to simllar features. In this embodiment, an alternative core wire 10 as is 11 used, e.g., in Phantom~ guidewire products of C.R. Bard, Inc.
12 The distal barrel 22 (of Fig. 1) of core wire 10 is here extended 13 into a round straight 0.0015 inch diameter tip wire 42 14 approximately 0.424 inches (1.5 cm) in length. The tip wire 42 may be connected at the rounded protrusion 36 created by a welder 16 at the distal ends of the inner and helical coils. ;
17 In Figs. 7 and 8, is shown a third alternative 18 embodiment of the guidewire in accordance with the invention e wherein similar reference numerals are again applied to similar ~s 20 features. The distal barrel 22 (of Fig. 1) of core wire 10 is 21 here again extended into a round straight 0.0015 inch diameter 22 tip wire 42. The tip wire 42 is connected at the rounded 23 protrusion 36 created by a welder to the distal ends of the 24 helical and inner coils, 24, 38. One to four round forming wires 34 (as described with respect to Fig. 1) are secured to the s 26 reduced diameter segment 14 of the core wire 10 and connected to the rounded protrusion 36. The arrangement of Figs. 7 and 8 28 provides a guidewire with particular added strength and torque in the guidewire tip resulting from the combination of the one to ~ four und forming wires with the tip wire.

t i 3 ,.''.'i . .
1 It may be appreciated that the tip of each of the 2 above-described embodiments is strong yet flexible and easy to form. The structure of the guidewire, however, is not so 4 formable that the guidewire takes a permanent set when bent over on itself. In contrast, a prior art guidewire using a flattened 6 safety wire as a ribbon may facilitate the shaping of the 7 guidewire coil but the guidewire coil takes a permanent set when 8 bent over on itself.
While the invention has been described in its preferred embodiments, it is to be understood that the words which have 11 been used are words of description, rather than limitation, and 12 that changes may be made within the purview of the appended 13 claims without departing from the true scope and spirit of the 14 inven on i its broader aspects.

,., .
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: ~:

Claims (35)

1. A guidewire, comprising:
a helical coil;
a core wire extending into a lumen of said helical coil and having a proximal end of said helical coil fixedly attached thereto;
at least one round forming wire fixedly attached to a distal region of said core wire and extending through the lumen of said helical coil; and a protrusion provided at a distal end of said helical coil with said at least one forming wire and said helical coil fixedly attached thereto.
2. A guidewire in accordance with claim 1, wherein said at least one round forming wire is fixedly attached to said core wire by a brazed joint.
3. A guidewire in accordance with claim 1, wherein the distal region of said core wire is of lesser diameter than a proximal region thereof.
4. A guidewire in accordance with claim 1, wherein said protrusion is formed by melting said helical coil and said at least one round forming wire into a rounded tip.
5. A guidewire in accordance with claim 1, wherein said helical coil is fixedly attached to said core wire by at least one brazed joint.
6. A guidewire in accordance with claim 1, wherein said helical coil is fixedly attached to said core wire at a tapered section thereof.
7. A guidewire in accordance with claim 6, wherein said helical coil is fixedly attached to said core wire by a brazed joint at a proximal end thereof.
8. A guidewire in accordance with claim 5, wherein said helical coil is fixedly attached to said core wire by a brazed joint along the length thereof.
9. A guidewire in accordance with claim 1, wherein individual coils of said helical coil are expanded along a partial length thereof.
10. A guidewire in accordance with claim 1, further comprising an inner coil extending through the lumen of said helical coil and fixedly attached at a proximal end thereof to said core wire and at a distal end thereof to said protrusion.
11. A guidewire in accordance with claim 10, wherein said inner coil is formed from a radiopaque material.
12. A guidewire in accordance with claim 11, wherein said radiopaque material is gold and platinum.
13. A guidewire, comprising:
a helical coil;
a core wire extending into a lumen of said helical coil and having a proximal end of said helical coil fixedly attached thereto;
at least one round forming wire integrally formed with a distal region of said core wire and extending through the lumen of said helical coil; and a protrusion provided at a distal end of said helical coil with said at least one forming wire and said helical coil fixedly attached thereto.
14. A guidewire in accordance with claim 13, wherein the distal region of said core wire is of lesser diameter than a proximal region thereof.
15. A guidewire in accordance with claim 13, wherein said protrusion is formed by melting said helical coil and said at least one round forming wire into a rounded tip.
16. A guidewire in accordance with claim 13, wherein said helical coil is fixedly attached to said core wire by at least one brazed joint.
17. A guidewire in accordance with claim 13, wherein said helical coil is fixedly attached to said core wire at a tapered section thereof.
18. A guidewire in accordance with claim 17, wherein said helical coil is fixedly attached to said core wire by a brazed joint at a proximal end thereof.
19. A guidewire in accordance with claim 16, wherein said helical coil is fixedly attached to said core wire by a brazed joint along the length thereof.
20. A guidewire in accordance with claim 13, wherein individual coils of said helical coil are expanded along a partial length thereof.
21. A guidewire in accordance with claim 13, further comprising an inner coil extending through the lumen of said helical coil and fixedly attached at a proximal end thereof to said core wire and at a distal end thereof to said protrusion.
22. A guidewire in accordance with claim 21, wherein said inner coil is formed from a radiopaque material.
23. A guidewire in accordance with claim 22, wherein said radiopaque material is gold and platinum.
24. A guidewire, comprising:

a helical coil;
a core wire extending into a lumen of said helical coil and having a proximal end of said helical coil fixedly attached thereto;
at least one round forming wire integrally formed with a distal region of said core wire and extending through the lumen of said helical coil; and at least one forming wire fixedly attached to a distal end of said core wire and extending through the lumen of said helical coil; and a protrusion provided at a distal end of said helical coil with said at least one forming wire and said helical coil fixedly attached thereto.
25. A guidewire in accordance with claim 24, wherein said at least one round forming wire fixedly attached to said core wire is fixedly attached by a brazed joint.
26. A guidewire in accordance with claim 24, wherein the distal region of said core wire is of lesser diameter than a proximal region thereof.
27. A guidewire in accordance with claim 24, wherein said protrusion is formed by melting said helical coil and said at least one forming wire into a rounded tip.
28. A guidewire in accordance with claim 24, wherein said helical coil is fixedly attached to said core wire by at least one brazed joint.
29. A guidewire in accordance with claim 24, wherein said helical coil is fixedly attached to said core wire at a tapered section thereof.
30. A guidewire in accordance with claim 29, wherein said helical coil is fixedly attached to said core wire by a brazed joint at a proximal end thereof.
31. A guidewire in accordance with claim 28, wherein said helical coil is fixedly attached to said core wire by a brazed joint along the length thereof.
32. A guidewire in accordance with claim 24, wherein individual coils of said helical coil are expanded along a partial length thereof.
33. A guidewire in accordance with claim 24, further comprising an inner coil extending through the lumen of said helical coil and fixedly attached at a proximal end thereof to said core wire and at a distal end thereof to said protrusion.
34. A guidewire in accordance with claim 33, wherein said inner coil is formed from a radiopaque material.
35. A guidewire in accordance with claim 34, wherein said radiopaque material is gold and platinum.
CA002115198A 1993-02-09 1994-02-08 Guidewire with round forming wire Abandoned CA2115198A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US015,642 1993-02-09
US08/015,642 US5377690A (en) 1993-02-09 1993-02-09 Guidewire with round forming wire

Publications (1)

Publication Number Publication Date
CA2115198A1 true CA2115198A1 (en) 1994-08-10

Family

ID=21772609

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002115198A Abandoned CA2115198A1 (en) 1993-02-09 1994-02-08 Guidewire with round forming wire

Country Status (6)

Country Link
US (1) US5377690A (en)
EP (1) EP0611073B1 (en)
JP (1) JPH06292729A (en)
CA (1) CA2115198A1 (en)
DE (1) DE69402348T2 (en)
ES (1) ES2100629T3 (en)

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Also Published As

Publication number Publication date
EP0611073A1 (en) 1994-08-17
US5377690A (en) 1995-01-03
ES2100629T3 (en) 1997-06-16
DE69402348D1 (en) 1997-05-07
JPH06292729A (en) 1994-10-21
DE69402348T2 (en) 1997-08-21
EP0611073B1 (en) 1997-04-02

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