WO1990005486A1 - Fils de guidage de petit diametre - Google Patents

Fils de guidage de petit diametre Download PDF

Info

Publication number
WO1990005486A1
WO1990005486A1 PCT/US1989/005098 US8905098W WO9005486A1 WO 1990005486 A1 WO1990005486 A1 WO 1990005486A1 US 8905098 W US8905098 W US 8905098W WO 9005486 A1 WO9005486 A1 WO 9005486A1
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
sheath
structural element
inch
distal
Prior art date
Application number
PCT/US1989/005098
Other languages
English (en)
Inventor
Fernando Alvarez De Toledo
Original Assignee
Boston Scientific Corporation
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 Boston Scientific Corporation filed Critical Boston Scientific Corporation
Publication of WO1990005486A1 publication Critical patent/WO1990005486A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12—Arrangements for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

  • This invention relates to medical guidewires, including medical injection wires.
  • Medical devices consisting of elongated spring coils are employed widely as guidewires, e.g., for negotiating narrow, tortuous passageways of the body to a site to be treated, and then serving as guides for catheters or other larger diameter devices advanced over the guidewires.
  • the guidewire be as small in diameter as possible, particularly in the tip region, but not so small as to create a danger of the tip breaking loose in the body; that the distal tip region be highly flexible to permit negotiation of difficult turns within the body; that the guidewire also be stiff enough axially to be advanced by pressure from the proximal end outside the body; and that the guidewire have good steerability or torque response, i.e., the tip-to-handle turn ratio should be as close to 1:1 as possible, without whipping.
  • Most prior art guidewires offer a compromise of these desired features, e.g., trading tip flexibility for good torque response.
  • spring coils are in catheter-like medical injection wires or the like which require characteristics similar to those described above.
  • An example of such a device is described in Tate U.S. 3,841,308 as having a spring coil covered with a polyfluoroethylene flexible coating or sheath for delivery of fluid to ports adjacent the distal end.
  • a medical guidewire having a distal tip portion for advancement through a body by application of force to a proximal end portion comprises an elongated multi-filar coil structural element, and a sheath disposed thereabout and along a substantial portion of the length of the structural element, the sheath formed of material that is non-corrosive within the body, and the sheath being adapted to flex in unison with the structural element without kinking, the sheath and structural element in combination having a torque response along the joined length approaching 1:1, thereby allowing control of the distal tip of the guidewire within a body by application of rotational force to the proximal end portion outside the body.
  • a core element formed of elongated metal is disposed within the structural element.
  • the distal end of the structural element and the sheath define an orifice for delivery of a fluid through the element to a body.cavity.
  • Preferred embodiments of each of the above may include one or more of the following features.
  • the sheath is disposed along the majority of the element, and has a wall thickness of less than 0.0025 inch (0.064 mm).
  • the material is able to withstand a pressure of at least 300 psi (21.1 kg/cm 2 ) .
  • the material is able to withstand a pressure of at least about 700 psi (50 kg/cm 2 ) and/or the material has a tensile strength of at least 15,000 psi (1,050 kg/cm 2 ) , is not brittle, has a low elongation factor and is dimensionally stable; whereby the material can allow radiopaque fluid to be inserted into a body cavity through the guidewire in sufficient amount to provide good X-ray contrast at the site of insertion.
  • the material is resistant to heat at temperatures suitable for soldering, to allow soldering of material to the structural element.
  • the material has a uniform wall thickness so that the guidewire provides as little trauma to the body cavity as possible as it passes through the body cavity.
  • the material has no pin holes so that fluid does not leak through the material.
  • the sheath has a wall thickness of between 0.00075 inch (0.019 mm) and 0.0015 inch (0.038 mm). The wall thickness varies less than 0.0002 inch (0.005 mm) along the length of the sheath.
  • the sheath has an inner diameter of at least 0.0075 inch (0.19 mm).
  • the material comprises polyimide.
  • the core element has a distal tapered region, and the core element is fixedly attached within the structural element proximally from the tapered region.
  • the structural element has an inner diameter greater than the outer diameter of the core element by about 0.0005 inch (0.013 mm).
  • the guidewire further comprises an electron dense material, e.g. platinum, in its distal region.
  • the guidewire further comprises a sleeve positioned about the distal tapered region of the core element, the sleeve providing a transition between the core element and the tip of the guidewire.
  • the sleeve comprises polyimide material.
  • the structural element is a cross-wound multi- filar element.
  • the cross-wound multi-filar element comprises an inner coil formed of wire having a flat cross-section.
  • the core element is soldered to the structural element.
  • the sheath is fixed to the structural element, e.g. by glue. The sheath extends along the distal end of the structural element and is fixed at the distal end of the element.
  • the structural element has an inner diameter of greater than 0.022 inch (0.56 mm) and the guidewire has an outer diameter of less than 0.040 inch (1.02 mm).
  • the structural element comprises a wound multi-filar element. The distal end of the sheath is spaced from the distal end of the structural element.
  • a method for forming a guidewire comprises the steps of providing an elongated structural element, disposing a sheath thereabout and along a substantial portion of the element, and gluing the sheath to the structural element.
  • Guidewires of this invention can be made to extremely small diameter (less than 0.018 inch) and provide high torque response (e.g., at least approaching 1:1) of proximal to distal ends with high visibility of the tip region.
  • the polyimide sheath acts in conjunction with a wound multi-filar coil to provide this torque.
  • the distal tip of the guidewire is without a sheath to provide a softer tip region.
  • a core provided within a guidewire is fixed to the inner coil of the guidewire but is separated along the majority of its length from that coil by about 0.0005 inch.
  • the core element only contacts the inner coil constantly when the guidewire is caused to bend, for example, around a curve in a body cavity. At these curves the contact with the core element provides better torque to the guidewire.
  • a polyimide sheath is particularly suited for use in this invention because it provides the features described above, and can be formed into an extremely thin walled material with small inner diameter.
  • Injection wires of this invention provide means by which an extremely small diameter tube can be inserted within a body cavity and still allow a significant amount of fluid to be placed within the cavity at a desired site, since the injection wire has a relatively large lumen and can withstand high fluid pressure.
  • FIGs. 1 and 2 are sectional views of multi-filar cross-wound spring coil high torque guidewires of the invention.
  • Figs. 3 and 4 are sectional views, partly in isometric view, of wound multi-filar guidewires formed as injection wires.
  • torqueable coronary guidewire 10 has a length of about 145 cm, an outer diameter A, about 0.018 inch (0.46 mm), and is formed of an inner coil 12 and an outer coil 14 joined distally at a ball tip element 16, and joined proximally, e.g., by soldering, at a region 18.
  • Inner coil 12 is bifilar, formed of two flat platinum wires, 20, 22, e.g., about 0.002 inch (0.05 mm) by 0.006 inch (0.15 mm), closely wound at a pitch ratio of about 2:1.
  • Inner coil 12 extends only about 6-8 inches (15 to 20 cm) from ball tip element 16.
  • Outer coil 14 is quadrifilar, formed of four stainless steel circular cross-sectional wires 24, 26, 28, 30 of between 0.002 inch (0.05 mm) and 0.003 inch (0.075 mm) diameter, which are closely wound about inner coil 12, but in a direction opposite to the winding direction of inner coil 12, with a pitch ratio of about 4:1. Outer coil 14 extends the length of guidewire 10.
  • a sheath 32 formed of polyimide of thickness 0.00075 inch (0.019 mm) is provided tightly fitted around outer coil 14. Sheath 32 extends from proximal end 34 to a distance C, about 2 to 3 cm, from distal end 36.
  • Distal end 38 of sheath 32 is fixed by glue 40 (e.g., cyanoacrylate) to outer coil 14, and along a length of about 3 to 4 cm in the nearby distal region 33.
  • Proximal end 39 of sheath 32 is bonded by cyanoacrylate 50 to the proximal end of outer coil 14.
  • a core 42 Disposed within inner coil 12 is a core 42 formed of a stainless steel rod of outer base diameter B, about 0.010 inch (0.25 mm), with about a 0.0005 inch (0.013 mm) clearance from inner coil 12. Core 42 and inner coil 12 interact by close fit interference. Core 42 has a distal tapered portion 44 of length about 6 to 8 inches (15 to 20 cm) corresponding generally to the length of inner coil 12, beginning at step 46. Core 42 is fixed to outer coil 14 proxi ally from tapered portion 44 by solder or adhesive 51.
  • a polyimide sleeve 52 of length E e.g. about 2 cm, outer diameter D, 0.0095 inch (0.24 mm), and wall thickness 0.001 inch (0.025 mm), slid onto the distal end of tapered portion 44 to provide a smooth transition from tapered portion 44 to ball tip element 16, and thereby increase torque transmission to ball tip element 16.
  • Sleeve 52 is not fixed to ball tip element 16.
  • FIG. 2 there is shown another guidewire 60, of diameter H, about 0.018 inch (0.46 mm), having a construction similar to guidewire 10, shown in Fig. 1 and described above.
  • Guidewire 60 is formed with an inner coil 62 formed of a flat wire, and outer coil 64, formed of a circular wire, both extending the length of guidewire 60 and being encased within a polyimide sheath 66 along their length, except for a distance G of 3 to 5 cm at the distal tip.
  • Sheath 66 is bonded by cyanoacrylate (50') to outer coil 64 at its distal end, and inner coil 62 is soldered (51*) at its proximal end to core 68, as described above.
  • Inner core 68 of outer diameter I, about 0.006 inch (0.15 mm), has a tapered tip 69 having a tapered region 70 of length L, about 3 cm, and a flat tip portion 72 of length F, about 2 cm.
  • Proximal end 74 of core 68 has a single filar coil 73 attached to it (e.g., by adhesive) to provide a handle 74.
  • core 68 has a clearance from inner coil 62 of about 0.0005 inch (0.013 mm).
  • Inner coil 62 and outer coil 64 are formed of stainless steel except for a distal region M, of length about 5 cm, formed of platinum and glued or soldered (not shown) to the stainless steel coils. Referring to Figs.
  • injection wire 80 has a length of about 100 to 150 cm, and is affixed at its proximal end to fluid delivery device 82, for example, a syringe.
  • Injection wire 80 is formed of a bifilar or quadrifilar coil 84 of wire diameter 0.005 inch (0.13 mm) formed with a lumen of diameter Q, 0.027 inch (0.69 mm), and enveloped by a polyimide sheath of nominal outer diameter P, about 0.038 inch (0.97 mm) .
  • Polyimide sheath 86 and coil 84 are fixed together at the extremities by glue 88 such that polyimide sheath 86 extends a distance N, about 0.5 to 2.0 mm, beyond a tip 89 of coil 84.
  • injection wire 90 is formed as described above for injection wire 80, except coils 92 are fixed together by solder 93 to each other and subsequently bonded by cyanoacrylate to polyimide sleeve 94 in distal region 96 such that the tip of coil 92 and the tip of polyimide sheath 94 are adjacent and coextensive.
  • injection wires are able to withstand high pressure fluid and allow delivery of substantial amounts of fluid to any desired region within a body cavity.
  • These wires may be used in conjunction with a movable and removable core, or a standard 0.025 inch (0.64 mm) guidewire.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Physics & Mathematics (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Anesthesiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un fil métallique de guidage (10) à usage médical possède une pointe distale que l'on introduit et que l'on fait avancer dans un corps en appliquant une force à une extrémité proximale. Le fil de guidage comprend un élément structurel en serpentin multifil allongé (12, 14) et une gaine (32) disposée autour de l'élément et le long d'une grande partie de la longueur de l'élément structurel, la gaine étant constituée d'un matériau non corrosif pour le corps humain. La gaine fléchit de concert avec l'élément structurel sans vrillage. La gaine et l'élément structurel ont, en combinaison, une courbe de torsion le long de la longueur où ils sont joints qui avoisine 1:1, ce qui permet de commander la pointe distale du fil de guidage à l'intérieur d'un corps humain en applicant une force de rotation à la partie d'extrémité proximale extérieure au corps.
PCT/US1989/005098 1988-11-23 1989-11-17 Fils de guidage de petit diametre WO1990005486A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US27610688A 1988-11-23 1988-11-23
US276,106 1988-11-23

Publications (1)

Publication Number Publication Date
WO1990005486A1 true WO1990005486A1 (fr) 1990-05-31

Family

ID=23055193

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1989/005098 WO1990005486A1 (fr) 1988-11-23 1989-11-17 Fils de guidage de petit diametre

Country Status (3)

Country Link
EP (1) EP0435961A1 (fr)
CA (1) CA2003447A1 (fr)
WO (1) WO1990005486A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0386921A2 (fr) * 1989-03-02 1990-09-12 Microspring Company, Inc. Dispositif pour transmettre un couple de rotation
WO1992004072A1 (fr) * 1990-08-29 1992-03-19 Baxter International Inc. Fil de guidage a double bobine a extremite distale radio-opaque
US5345945A (en) * 1990-08-29 1994-09-13 Baxter International Inc. Dual coil guidewire with radiopaque distal tip
EP0729765A1 (fr) * 1995-03-02 1996-09-04 Schneider (Europe) Ag Fil de guidage
EP0738495A1 (fr) * 1995-04-18 1996-10-23 Schneider (Europe) Ag Fil de guidage pour la mesure de pression
WO1999019018A3 (fr) * 1997-10-16 1999-07-29 Scimed Life Systems Inc Pointe guide-fil

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3749086A (en) * 1972-07-24 1973-07-31 Medical Evaluation Devices & I Spring guide with flexible distal tip
US3841308A (en) * 1973-10-15 1974-10-15 Medical Evaluation Devices & I Distally valved catheter device
US4020829A (en) * 1975-10-23 1977-05-03 Willson James K V Spring guide wire with torque control for catheterization of blood vessels and method of using same
US4676249A (en) * 1986-05-19 1987-06-30 Cordis Corporation Multi-mode guidewire
US4719924A (en) * 1986-09-09 1988-01-19 C. R. Bard, Inc. Small diameter steerable guidewire with adjustable tip
US4798598A (en) * 1986-05-23 1989-01-17 Sarcem S.A. Guide for a catheter
US4800890A (en) * 1984-12-28 1989-01-31 Cramer Bernhard M Steerable guide wire for catheters
US4846186A (en) * 1988-01-12 1989-07-11 Cordis Corporation Flexible guidewire

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3749086A (en) * 1972-07-24 1973-07-31 Medical Evaluation Devices & I Spring guide with flexible distal tip
US3841308A (en) * 1973-10-15 1974-10-15 Medical Evaluation Devices & I Distally valved catheter device
US4020829A (en) * 1975-10-23 1977-05-03 Willson James K V Spring guide wire with torque control for catheterization of blood vessels and method of using same
US4800890A (en) * 1984-12-28 1989-01-31 Cramer Bernhard M Steerable guide wire for catheters
US4676249A (en) * 1986-05-19 1987-06-30 Cordis Corporation Multi-mode guidewire
US4798598A (en) * 1986-05-23 1989-01-17 Sarcem S.A. Guide for a catheter
US4719924A (en) * 1986-09-09 1988-01-19 C. R. Bard, Inc. Small diameter steerable guidewire with adjustable tip
US4846186A (en) * 1988-01-12 1989-07-11 Cordis Corporation Flexible guidewire

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0386921A2 (fr) * 1989-03-02 1990-09-12 Microspring Company, Inc. Dispositif pour transmettre un couple de rotation
EP0386921A3 (fr) * 1989-03-02 1991-07-31 Microspring Company, Inc. Dispositif pour transmettre un couple de rotation
WO1992004072A1 (fr) * 1990-08-29 1992-03-19 Baxter International Inc. Fil de guidage a double bobine a extremite distale radio-opaque
US5345945A (en) * 1990-08-29 1994-09-13 Baxter International Inc. Dual coil guidewire with radiopaque distal tip
EP0729765A1 (fr) * 1995-03-02 1996-09-04 Schneider (Europe) Ag Fil de guidage
US5706826A (en) * 1995-03-02 1998-01-13 Schneider (Europe) A.G. Guide wire with helical coil
EP0738495A1 (fr) * 1995-04-18 1996-10-23 Schneider (Europe) Ag Fil de guidage pour la mesure de pression
US5916177A (en) * 1995-04-18 1999-06-29 Schneider (Europe) A.G. Pressure measuring guide wire
US6183424B1 (en) 1995-04-18 2001-02-06 Schneider (Europe) A.G. Pressure measuring guide wire
WO1999019018A3 (fr) * 1997-10-16 1999-07-29 Scimed Life Systems Inc Pointe guide-fil
US6132388A (en) * 1997-10-16 2000-10-17 Scimed Life Systems, Inc. Guide wire tip

Also Published As

Publication number Publication date
EP0435961A1 (fr) 1991-07-10
CA2003447A1 (fr) 1990-05-23

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