WO1997038747A1 - A guidewire with a variable stiffness distal portion - Google Patents
A guidewire with a variable stiffness distal portion Download PDFInfo
- Publication number
- WO1997038747A1 WO1997038747A1 PCT/US1997/006769 US9706769W WO9738747A1 WO 1997038747 A1 WO1997038747 A1 WO 1997038747A1 US 9706769 W US9706769 W US 9706769W WO 9738747 A1 WO9738747 A1 WO 9738747A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- core section
- guidewire
- proximal
- distal
- intermediate core
- Prior art date
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
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0158—Tip steering devices with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
-
- 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
- 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
- A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
- A61M2025/09141—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque made of shape memory alloys which take a particular shape at a certain temperature
-
- 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
- a GUIDEWIRE WITH A VARIABLE STIFFNESS DISTAL PORTION BACKGROUND OF THE INVENTION This invention relates to the field of medical devices, and more
- guiding means such as a guidewire for advancing a
- catheter within a body lumen to perform a procedure such as
- PTCA percutaneous transluminal coronary angioplasty
- a guiding catheter is seated in the ostium of a desired coronary artery.
- guidewire is positioned within an inner lumen of a dilatation catheter
- the guidewire is first advanced out of the distal end of the guidewire
- the balloon is inflated one or more times to a predetermined
- radiopaque liquid at relatively high pressures (e.g., greater than 4 atmospheres) to compress the arteriosclerotic plaque of the
- the balloon is then deflated so that blood
- procedures usually comprise an elongated core member with the distal
- portion of the core member having one or more tapered sections and a
- a shapable member which may be the distal
- Torquing means are provided on the proximal end of the
- Patent 4,554,929 (Samson, et al.); U.S. Patent 4,616,652 (Simpson),
- NITINOL Ni-Ti alloy which have shape memory and/or superelastic or
- characteristics on the other hand generally allow the metal to be deformed and restrained in the deformed condition to facilitate the
- phase transformation e.g.
- the superelastic member can be removed, thereby reducing the stress
- Alloys have shape memory/superelastic characteristics generally
- martensite phase which has a relatively
- austenite phase which has a relatively high strength and which is
- the constrained shape of the metal during this heat treatment is the shape "remembered" when the alloy is
- phase may be plastically deformed to facilitate the entry thereof into a
- transformation temperature causes the deformed martensite phase to
- the devices could be any shape memory alloys having martensite-to-austenite transformation temperatures well above body temperature.
- austenite phase to facilitate manufacturing such as centerless grinding
- the guidewire of the invention generally has a high strength
- proximal core section an intermediate core section formed at least in part of a NiTi alloy which has a significant level of martensite phase at
- a distal core section may have a flexible body, such as a
- helical coil disposed about and secured to at least part of the distal core section.
- the intermediate core section should have about 10%
- phase can have inadequate strength to be readily pushed through
- the conversion to the austenite phase should be nearly complete, i.e.
- phase is to weight percent unless noted otherwise.
- Means are provided to heat the intermediate core section while it
- the intermediate core section is provided with a straight memory in the austenite phase
- electrical conductor is electrically connected by its distal end to a
- second electrical conductors is electrically connected by its distal end
- the proximal ends of the electrical conductors are electrically
- one or more temperature sensor or other means are provided.
- martensite phase provides excellent flexibility to the distal part of the guidewire which allows the guidewire to pass through tortuous
- the martensite of the intermediate core section is
- the intermediate core section are selected to provide an austenite
- the memory inducing heat treatment is selected to provide a
- phase not greater than about 50°C, preferably not greater than about
- the intermediate core section is preferably formed from an alloy
- Such other alloying elements may be selected from the group consisting of up to 3% each of iron, cobalt, platinum, palladium
- the presently preferred alloy composition is about
- elongated member of the preferred alloy material is first cold worked
- thermomechanical processing imparts a straight "memory" to the
- austenite transformation temperature is preferably less than body temperature and generally about -10° C to about 30° C.
- metal other than drawing such as rolling or swaging, can be employed.
- the cold-worked and heat-treated NiTi alloy material is in the
- section is to be mechanically worked, e.g. centeriess grinding to the
- the intermediate core section and the distal core section are initially formed from the same
- the intermediate core section is
- distal core section which is used in the austentite phase, is assembled
- core sections are preferably connected to proximal and distal ends of
- tubular connector element which is formed of essentially the same NiTi
- Fig. 1 is an elevational view, partially in section, of a guidewire
- Fig. 2 is a transverse cross-sectional view of the guidewire
- Fig. 3 is a transverse cross-sectional view of the guidewire shown in Fig. 1 taken along the lines 3-3.
- Fig. 4 is a transverse cross-sectional view of the guidewire
- Fig. 5 is a longitudinal cross-sectional view of an electrical
- Fig. 6 is a top view, partially in section, of the connector shown
- Fig. 7 is a longitudinal view, partially in section of an alternative
- Fig. 8 is a transverse cross-sectional view of the guidewire
- Fig. 9 is a transverse cross-sectional view of the guidewire
- Fig. 10 is a partial elevational view, partially in section, of an
- Fig. 11 is a partial elevational view, partially in section, of
- Fig. 12 is a transverse cross-sectional view of the guidewire
- Fig. 13 is a transverse cross-sectional view of the guidewire
- FIGs. 1-4 illustrate a guidewire 10 which embodies features of
- the guidewire 10 includes a elongated shaft
- a helical coil 15 is disposed about the distal
- core section 14 and is secured by solder or adhesive at locations 16
- a shaping ribbon 18 is secured by its proximal end to the
- distal core section 14 at location 17 and by its distal end to the distal end of the helical coil 15 by welding or brazing forming the rounded
- a first cylindrical connector member 20 interconnects the distal end of
- cylindrical connector members 20 and 21 may be secured to the
- members 20 ans 21 are formed of a NiTi alloy which generates a
- the proximal core section 12 is provided with a pair of
- Insulating layer 26 which is disposed
- proximal core section from the electrode 22 proximal core section from the electrode 22, and, as shown is Fig. 1 ,
- the conducting layer 24 extends to location 27 on the proximal end of the
- An intermediate insulating layer 28 is provided on the surface of
- conducting layer 25 extends distally on top of the intermediate
- a third insulating layer 31 is
- layers may be applied by dip coating, spraying or other suitable
- FIGs. 5-6 schematically illustrate an electrical connector 40 for
- the connector 40 has an elongated passageway 41
- the connector 40 has a pair of electrical contacts 43 and 44 which are spaced along
- the electrical contacts 43 and 44 are ball bearings which are urged into contact with the electrodes 22 and 23 by the
- a screw clamp 52 is
- Electrical conductors 53 and 54 are
- a high frequency electrical energy e.g. RF
- the proximal core section 12 of this embodiment has a solid core
- Insulated electrical conducting wire 59 is electrically connected by its
- insulating sheath 61 is
- insulating sheath 62 is disposed between the proximal end of the
- Polyimide is a
- wire 59 is electrically connected by its distal end to the distal portion of
- a polymer sleeve 66 is
- the distal end of the guidewire 10 has essentially
- Fig. 10 depicts another alternate embodiment of the invention
- the guidewire 10 has the proximal electrode 22 electrically
- conductor wire 70 is electrically connected to the distal electrode 23.
- 71 covers the exterior of the proximal core section 12 to insulate the
- Cylindrical connector 20 mechanically and
- wire 70 electrically interconnects the distal electrode 23 with the distal
- connector member 21 to electrically isolate the distal core section from
- An outer polymer jacket 74 is provided
- proximal core section has a proximal solid core portion 80 with a distal tubular portion 81 which is electrically and mechanically
- Electrode 22 of the guidewire 10 is
- electrode 23 is electrically connected to the proximal end of individually insulated electrical conductor wire 82 which has its distal end
- Insulating layer 84 is disposed about the distal end of the
- Insulating layer 85 is disposed between the
- An outer jacket 86 is
- the distal portion of the guidewire 10 is essentially the same as in the
- the overall dimensions of the guidewire are generally about 140
- intermediate and distal core sections may be substantially smaller
- the intermediate core sections has a length of about 15 to about 40 cm,
- the distal core section is about
- the distal core 3 to about 15 cm, preferably about 4 to about 7 cm.
- section may have one or more tapers and the most distal part is
- the intermediate core section is formed of a shape memory NiTi
- the preferred alloy composition is about 51%
- the distal core section 14 is preferably formed from the same alloy but
- the guidewire of the invention is utilized in essentially the same
- the intermediate core section is heated to a temperature which
- guidewire must be long enough for its distal end to extend out the distal
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP9537440A JP2000508564A (en) | 1996-04-18 | 1997-04-18 | Guidewire with variable stiffness proximal end |
EP97923441A EP0894015A1 (en) | 1996-04-18 | 1997-04-18 | A guidewire with a variable stiffness distal portion |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/634,208 US5931819A (en) | 1996-04-18 | 1996-04-18 | Guidewire with a variable stiffness distal portion |
US08/634,208 | 1996-04-18 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1997038747A1 true WO1997038747A1 (en) | 1997-10-23 |
Family
ID=24542841
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/006769 WO1997038747A1 (en) | 1996-04-18 | 1997-04-18 | A guidewire with a variable stiffness distal portion |
Country Status (5)
Country | Link |
---|---|
US (3) | US5931819A (en) |
EP (1) | EP0894015A1 (en) |
JP (1) | JP2000508564A (en) |
CA (1) | CA2251748A1 (en) |
WO (1) | WO1997038747A1 (en) |
Cited By (5)
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EP0925803A3 (en) * | 1997-12-22 | 1999-09-01 | Radi Medical Systems Ab | Guide wire |
US6485507B1 (en) | 1999-07-28 | 2002-11-26 | Scimed Life Systems | Multi-property nitinol by heat treatment |
WO2003002166A1 (en) * | 2001-06-29 | 2003-01-09 | Advanced Cardiovascular Systems, Inc. | Cold worked nickel-titanium divices |
US6592570B2 (en) * | 1990-12-18 | 2003-07-15 | Advanced Cardiovascular Systems, Inc. | Superelastic guiding member |
WO2015158757A1 (en) * | 2014-04-16 | 2015-10-22 | Institut National Des Sciences Appliquees De Lyon | Guide wire with controlled variable flexibility |
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JP2002058748A (en) * | 1998-12-11 | 2002-02-26 | Paiorakkusu:Kk | Guide wire for catheter and production method thereof |
US6142958A (en) * | 1998-12-23 | 2000-11-07 | Radi Medical Systems Ab | Sensor and guide wire assembly |
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Cited By (8)
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US6592570B2 (en) * | 1990-12-18 | 2003-07-15 | Advanced Cardiovascular Systems, Inc. | Superelastic guiding member |
EP0925803A3 (en) * | 1997-12-22 | 1999-09-01 | Radi Medical Systems Ab | Guide wire |
US6485507B1 (en) | 1999-07-28 | 2002-11-26 | Scimed Life Systems | Multi-property nitinol by heat treatment |
US6997947B2 (en) | 1999-07-28 | 2006-02-14 | Boston Scientific Scimed, Inc. | Multi-property nitinol by heat treatment |
US6602272B2 (en) | 2000-11-02 | 2003-08-05 | Advanced Cardiovascular Systems, Inc. | Devices configured from heat shaped, strain hardened nickel-titanium |
WO2003002166A1 (en) * | 2001-06-29 | 2003-01-09 | Advanced Cardiovascular Systems, Inc. | Cold worked nickel-titanium divices |
WO2015158757A1 (en) * | 2014-04-16 | 2015-10-22 | Institut National Des Sciences Appliquees De Lyon | Guide wire with controlled variable flexibility |
FR3019993A1 (en) * | 2014-04-16 | 2015-10-23 | Inst Nat Sciences Appliq | CONTROLLED VARIABLE FLEXIBILITY GUIDE WIRE |
Also Published As
Publication number | Publication date |
---|---|
US20010039412A1 (en) | 2001-11-08 |
CA2251748A1 (en) | 1997-10-23 |
US5931819A (en) | 1999-08-03 |
EP0894015A1 (en) | 1999-02-03 |
US6287292B1 (en) | 2001-09-11 |
JP2000508564A (en) | 2000-07-11 |
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