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WO1992008501A1 - Catheter a fil fixe muni d'un fil de transmission unitaire - Google Patents

Catheter a fil fixe muni d'un fil de transmission unitaire Download PDF

Info

Publication number
WO1992008501A1
WO1992008501A1 PCT/US1991/007394 US9107394W WO9208501A1 WO 1992008501 A1 WO1992008501 A1 WO 1992008501A1 US 9107394 W US9107394 W US 9107394W WO 9208501 A1 WO9208501 A1 WO 9208501A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
distal end
flat portion
catheter
tapered
Prior art date
Application number
PCT/US1991/007394
Other languages
English (en)
Inventor
Dong Ik Shin
Leo R. Rocher, Jr.
Original Assignee
Medtronic, 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 Medtronic, Inc. filed Critical Medtronic, Inc.
Publication of WO1992008501A1 publication Critical patent/WO1992008501A1/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
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • 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
    • A61M2025/09008—Guide wires having a balloon
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics

Definitions

  • This invention relates to catheters, particularly fixed wire catheters for opening lesions in arteries, and guidewires for guiding such catheters in the vascular system.
  • One type the "over-the- wire catheter,” slides over a separate guidewire.
  • the second type a “fixed wire catheter” has a guidewire built into the catheter in the unit.
  • the device must first be stiff enough to be able to be pushed into the vascular system.
  • the tip is bent into a "J" shape ahead of time.
  • torque must be transmitted down the guidewire or down the core wire of the catheter.
  • torque transmission down the wire or shaft is an important characteristic.
  • the device must be flexible.
  • U.S. Patent no. 4,721,117 issued to Mar et al. discloses a single piece wire with a flattened distal tip.
  • U.S. Patent No. 4,811,743 issued to Stevens discloses a unitary stainless steel wire with a flat distal portion and an unflattened end portion having about the same cross-sectional area as the flattened portion. The end is TIG welded with a tip spring in place to form a spherical distal tip that rotates independent of the distal end of the tip spring. All of these wires have had benefits and faults resulting from their design.
  • the invention is a fixed wire catheter having a torque-transmitting guidewire or shaft, a flexible body surrounding the shaft, and an inflatable balloon
  • the torque-transmitting is comprised of a single or unitary core wire.
  • the core wire is comprised of a cylindrical main shaft, a flat distal portion, and a cylindrical distal end, but it may have a tapered (or stepped) portion between the shaft and the flat portion.
  • the distal end is generally larger in cross-sectional area than the flat portion.
  • the core wire may have two or three tapered (or stepped) portions and one or more smaller shafts therebetween, all disposed between the main shaft and the flat portion.
  • the wire has a tapered portion between the flat portion and the distal tip, and the tapered portion is preferably radiused, for a strengthened member.
  • the catheter may further include a tip spring having a proximal end fixedly mounted to the shaft proximal to the distal end of the balloon and a distal end fixedly attached to the distal tip of the shaft.
  • a tip spring having a proximal end fixedly mounted to the shaft proximal to the distal end of the balloon and a distal end fixedly attached to the distal tip of the shaft.
  • it also includes a housing having a first body portion with a male segment with a longitudinal
  • the invention is a unitary or single core guidewire having a main cylindrical shaft, a distal flat portion and a dists! end larger in cross-sectional area than the cross-sectional area of the flat portion. Tapered portions may be included between the flat portion and the distal end, and the flat portion and the main shaft. 90 Multiple smaller shafts, and tapered portions, may be included between the main shaft and tapered portion. The taper between the flat portion and distal end is preferably radiused (or rolled) for a strengthened member.
  • the invention in another aspect is a method of making the guidewire.
  • Figs. 1A and 1B are top plan views of a portion of unitary wires of the present invention.
  • Fig. 2 is a side view of another unitary wire of the present invention.
  • Fig. 3 is a side view in cross-section of a fixed wire catheter according to the present invention.
  • 05- Fig. 4 is a greatly enlarged side view in cross-section of the distal tip of a fixed wire catheter according to the present invention.
  • Fig. 5 is a side view in cross-section of the proximal end of the fixed wire catheter and balloon of the present invention. 10
  • Fig. 6 is a side view, also in cross-section, of the proximal portion of the balloon and the adjacent catheter body in the present invention, all greatly enlarged.
  • the core or guidewire of the present invention comprises a single piece of material (i.e., is "unitary” or is a “single core wire"), usually stainless steel to form the wire.
  • the wire shown in Fig. 2 has a proximal cylindrical main shaft 2, a flat distal portion
  • a first tapered (or, equivalent ⁇ , stepped) segment 8 is located between shaft 2 and flat portion 4; a second tapered 10 segment also is located between flat portion 4 and end 6; it smoothly blends into the flat portion but not into end 6.
  • a straight tapered end such as 10 in Fig. 1 B is included, but sometimes the taper is radiused
  • End portion 6 may be of the same diameter, larger, or smaller than proximal shaft 2. Preferably it is the same size or slightly smaller in diameter than the main shaft. In the guidewire, it is larger in the cross-sectional area than the flat portion 6.
  • a tip coil 4 may be included and is preferably attached as shown in Fig. 4 illustrating the wire when it is included in a fixed wire catheter.
  • a second shaft 12 and third tapered segment 14 are disposed between the first tapered segment and the flat portion.
  • another cylindrical shaft 11 and fourth tapered segment 13 can be disposed between the flat portion and main shaft as shown in Fig. 1B.
  • the number of shafts of varying sizes are dictated by the requirements of the particular application.
  • the catheter core wire is preferably the version shown in Fig. 1A and the flat portion 4 is preferably only about one centimeter long and the end 6 is only a millimeter or less in length.
  • Taper 8 in this version, ends about 30 cm. from the distal tip, near the marker portion 160 shown in Figs. 3 and 4.
  • the catheter 110 includes a flexible catheter body 112, a unitary core wire 1 like that shown in Fig. 2, a balloon 116, a flexible tip 118, and a manifold or handle 120.
  • Handle 120 includes an arm 124 for mounting balloon inflation equipment and a second arm 126 for guidewire mounting.
  • a 150 rotatable handle 128 is mounted for rotation within arm 126.
  • catheter body 112 includes a body spring 140 which is a spring wound of metal of a rectangular cross-section.
  • Body spring 140 forms a lumen 142 through which the core wire 1 passes.
  • Mounted within lumen 142 is a 155 smaller diameter stainless steel spring 144 which is brazed to body spring 140 at brazed 146.
  • body spring 140 has an outside diameter of 0.30 inches and spring 144 has an outside diameter of .026 inches.
  • Flexible plastic tubing 148 is mounted over body spring 140, as in the prior art 160 Omniflex device.
  • tube 148 is made of polyethylene shaft stock.
  • Tubing 148 is tapered at its distal section 150 where it narrows to fit over spring 144.
  • Balloon 116 has a proximal section 152 mounted over the tapered section
  • adhesive 154 is an ultraviolet cured adhesive.
  • a radiopaque marker band 160 is mounted within balloon 16 on core wire 1, preferably by brazing. Marker 160 is made and 175 attached using common prior art techniques. Marker 160 is preferably a platinum cylinder, but may be platinum wire wound around wire 1. In order to have a smooth transition from wire 1 to marker 160, a ramp of adhesive 162 formed at either end of the marker 160. In the preferred embodiment, adhesive 162 is cyanoacrylate. f80
  • shaft 1 is the unitary core wire formed of a single piece of material as described above.
  • Separate tip spring or coil 14 preferably also made of platinum, is attached to core wire 1.
  • TIG Tumun inert gas
  • weakening of the wire due to the high temperatures required is minimized because the coil is welded distally to the large cylindrical distal end 6 rather than to a narrower, weaker portion such as
  • distal end portion 6 is smaller in diameter than main shaft 2 so that the overall diameter of the device with tip coil is the same as the diameter of the main shaft.
  • the tip coil in the preferred embodiment is brazed to core wire
  • spring 14 is fixed at either end but flexes throughout the rest of its structure.
  • a tip tube 182 is mounted over proximal portions of coil 14. It is attached to main shaft 2 of core wire 1 distally of the marker by adhesive 113 which in the preferred embodiment is cyanoacrylate. This seals the ' interior of tube 182 from the interior of balloon 116. Tip tube 182 extends distally through the distal end 186 of balloon 116. Distal end 86 of balloon 116 is bonded 05 to tube 182 by adhesive 115 which, in the preferred embodiment, is an ultraviolet cured adhesive. In turn, tube 182 is heat shrunk over coil 14, extends distal to the balloon, and acts as strain relief for the core wire.
  • the structure of catheter 110 provides a free moving guidewire within spring 14 so that the catheter is not susceptible to balloon wrap. When wire 1 is rotated, it moves freely within lumen 142 of body spring 140 and within tip spring 14. If shaft
  • proximal section 176 and distal section 178 of tip spring 14 are loosely wound springs which will absorb the torquing effect. This allows multiple turns of wire or shaft 1 without effect on balloon 116.
  • wire or shaft 1 is attached to strain relief means 190.
  • Shaft 1 continues through lumen 192 through silicone seal 194.
  • a threaded lumen 195 has female threads 196.
  • Guidewire housing 197 has male threads 198 which mate with threads 196. The interacting threads squeeze silicone seal 194 to prevent backfiow of fluid out of lumen 192.
  • Guidewire housing 197 has a longitudinal groove 199 which has a semicircular cross-section.
  • Rotatable handle 128 is mounted over second housing 197.
  • Handle 128 is held to housing 197 by spring clip 189 and has a bore 187 which is cut with helical threads 185.
  • the cross-section of helical thread 185 is a semicircle matching in diameter the cross-section of longitudinal groove 199.
  • a ball 183 is mounted to ride within groove 199 and helical threads 185.
  • ball 183 follows helical grooves 185 and moves, correspondingly, up and down longitudinal groove 199.
  • handle 128 can no longer rotate in that direction.
  • the amount of turn of rotatable handle 128 relative to housing 197 depends on the number of turns of helical groove 199.
  • handle 128 can be turned four times in either direction.
  • balloon twist does not occur in the design illustrated, the limitation on rotation reminds the physician that rotation has occurred in one
  • the use of the unitary core wire in the catheter of the present invention minimizes weak points in the wire by eliminating joints and minimizing heat damage from TIG
  • a cylindrical stainless steel wire is utilized. Tapered regions such as 8 and 10 are created by grinding as are the smaller shaft areas 11 and 12. The wire is then flattened as desired to 255 create flat distal portion 4.
  • a flat press can be used, but a roller is preferred, to smoothly form the flat portion and create a smooth transition to the tapered portion adjacent the distal end.
  • the remainder of the fixed wire catheter is made by conventional methods or by methods already described.
  • a guiding catheter is normally threaded through the vascular system to a position near the * f coronary veins or arteries.
  • the tip of the guidewire or the catheter core wire is then usually bent or deflected to promote steerability, and inserted and steered through the guiding catheter into the twisting pathways of the coronary arteries, to 65 the point of interest, usually just past a stenosis to be removed.
  • an over-the-wire catheter is then threaded over it for insertion into the vascular system and ultimate use.
  • the fixed wire catheter it is already inserted and is then used for the operation needed, for example, angioplasty, in the standard manner.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Cathéter (110) à fil possédant un arbre de transmission de couple, un corps souple entourant l'arbre (112), et un ballon gonflable (116) ayant une extrémité proximale montée sur le corps flexible. Dans ledit cathéter, l'arbre de transmission comprend un fil central unitaire (1). On décrit aussi un fil de transmission unitaire. En général, le fil central ou le fil de transmission se compose d'un arbre principal cylindrique (2), d'une partie distale plate (4), et d'une tête distale cylindrique (6), mais ledit fil de transmission peut aussi comprendre une section conique (8) entre l'arbre et la partie plate. L'extrémité distale est plus large, en coupe transversale, que la partie plate, et la section qui raccorde les deux parties est en général conique, décroissant de préférence dans la direction de l'extrémité distale. Le cathéter comporte un ressort de tête (14) comprenant une extrémité proximale fixée à demeure sur l'arbre à proximité de l'extrémité distale du ballon ainsi qu'une extrémité distale fixée à demeure à l'extrémité distale de l'arbre.
PCT/US1991/007394 1990-11-09 1991-10-03 Catheter a fil fixe muni d'un fil de transmission unitaire WO1992008501A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US61121090A 1990-11-09 1990-11-09
US611,210 1990-11-09

Publications (1)

Publication Number Publication Date
WO1992008501A1 true WO1992008501A1 (fr) 1992-05-29

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1991/007394 WO1992008501A1 (fr) 1990-11-09 1991-10-03 Catheter a fil fixe muni d'un fil de transmission unitaire

Country Status (1)

Country Link
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017027107A1 (fr) * 2015-08-10 2017-02-16 Gyrus Acmi, Inc. (D/B/A Olympus Surgial Technologies America) Marqueur de centre pour ballonnet de dilatation

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3789841A (en) * 1971-09-15 1974-02-05 Becton Dickinson Co Disposable guide wire
US4538622A (en) * 1983-11-10 1985-09-03 Advanced Cardiovascular Systems, Inc. Guide wire for catheters
US4664113A (en) * 1984-05-30 1987-05-12 Advanced Cardiovascular Systems, Inc. Steerable dilatation catheter with rotation limiting device
US4721117A (en) * 1986-04-25 1988-01-26 Advanced Cardiovascular Systems, Inc. Torsionally stabilized guide wire with outer jacket
US4757827A (en) * 1987-02-17 1988-07-19 Versaflex Delivery Systems Inc. Steerable guidewire with deflectable tip
US4763647A (en) * 1987-01-06 1988-08-16 C. R. Bard, Inc. Dual coil steerable guidewire
US4787399A (en) * 1986-07-29 1988-11-29 Sarcem S.A. Remote controlled catheter guide
US4796642A (en) * 1987-12-28 1989-01-10 Cordis Leads, Inc. Pacing lead stylet
US4811743A (en) * 1987-04-21 1989-03-14 Cordis Corporation Catheter guidewire
US4846174A (en) * 1986-08-08 1989-07-11 Scimed Life Systems, Inc. Angioplasty dilating guide wire

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3789841A (en) * 1971-09-15 1974-02-05 Becton Dickinson Co Disposable guide wire
US4538622A (en) * 1983-11-10 1985-09-03 Advanced Cardiovascular Systems, Inc. Guide wire for catheters
US4664113A (en) * 1984-05-30 1987-05-12 Advanced Cardiovascular Systems, Inc. Steerable dilatation catheter with rotation limiting device
US4721117A (en) * 1986-04-25 1988-01-26 Advanced Cardiovascular Systems, Inc. Torsionally stabilized guide wire with outer jacket
US4787399A (en) * 1986-07-29 1988-11-29 Sarcem S.A. Remote controlled catheter guide
US4846174A (en) * 1986-08-08 1989-07-11 Scimed Life Systems, Inc. Angioplasty dilating guide wire
US4763647A (en) * 1987-01-06 1988-08-16 C. R. Bard, Inc. Dual coil steerable guidewire
US4757827A (en) * 1987-02-17 1988-07-19 Versaflex Delivery Systems Inc. Steerable guidewire with deflectable tip
US4811743A (en) * 1987-04-21 1989-03-14 Cordis Corporation Catheter guidewire
US4796642A (en) * 1987-12-28 1989-01-10 Cordis Leads, Inc. Pacing lead stylet

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017027107A1 (fr) * 2015-08-10 2017-02-16 Gyrus Acmi, Inc. (D/B/A Olympus Surgial Technologies America) Marqueur de centre pour ballonnet de dilatation
US10940299B2 (en) 2015-08-10 2021-03-09 Gyms Acmi, Inc. Center marker for dilatation balloon

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