WO1997044086A1 - Procede et appareil fil de guidage/catheter a ballon flexible - Google Patents

Procede et appareil fil de guidage/catheter a ballon flexible Download PDF

Info

Publication number
WO1997044086A1
WO1997044086A1 PCT/US1997/008640 US9708640W WO9744086A1 WO 1997044086 A1 WO1997044086 A1 WO 1997044086A1 US 9708640 W US9708640 W US 9708640W WO 9744086 A1 WO9744086 A1 WO 9744086A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubular body
guide wire
catheter
section
balloon
Prior art date
Application number
PCT/US1997/008640
Other languages
English (en)
Inventor
Stephen C. Jacobsen
John Lippert
Clark Davis
Original Assignee
Sarcos, 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 Sarcos, Inc. filed Critical Sarcos, Inc.
Priority to AU31369/97A priority Critical patent/AU3136997A/en
Publication of WO1997044086A1 publication Critical patent/WO1997044086A1/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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • 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
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • 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
    • A61M25/0127—Magnetic means; Magnetic markers
    • 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
    • A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils

Definitions

  • This invention relates to catheter systems and more particularly to a flexible balloon catheter/guide wire apparatus and method.
  • Catheter guide wires have been used for many years to "lead” or “guide” catheters to desired target locations in the human body's vasculature.
  • the typical guide wire is from about 135 centimeters to 195 centimeters in length, and is made from two primary p ⁇ eces--a stainless steel solid core wire, and a platinum alloy coil spring.
  • the core wire is tapered on the distal end to increase its flexibility.
  • the coil spring is typically soldered to the core wire at its distal end and at a point where the inside diameter of the coil spring matches the outside diameter of the core wire. Platinum is selected for the coil spring because it provides radiopacity for X-ray viewing during navigation of the guide wire m the body, and it is biocompatible.
  • the coil spring also provides softness for the tip of the guide wire to reduce the likelihood of puncture of the anatomy.
  • Navigation through the anatomy is achieved by viewing the guide wire in the body using X-ray fluoroscopy.
  • the guide wire is inserted into a catheter so the guide wire protrudes out the end, and then the wire and catheter are inserted into a vessel or duct and moved therethrough until the guide wire tip reaches a desired vessel or duct branch.
  • the proximal end of the guide wire is then rotated or torqued to point the curved tip into the desired branch and then advanced farther.
  • the catheter is advanced over the guide wire to follow or track the wire to the desired location, and provide additional support for the wire.
  • the guide wire may be withdrawn, depending upon the therapy to be performed. Oftentimes, such as in the case of balloon angioplasty, the guide wire is left in place during the procedure and will be used to exchange catheters .
  • a balloon catheter/guide wire is formed of a thin, elongate, hollow tubular body of material, the exterior surface of which includes a plurality of cuts spaced apart along at least a portion of the length of the body, and some of which extend through to the interior of the tubular body. The cuts extend transversely of the body and are positioned to give the apparatus flexibility without significantly reducing torsional stiffness.
  • a balloon element is disposed about the tubular body near a distal end about at least some cuts which extend through the tubular body walls to the interior, so that fluid introduced into the hollow at a proximal end of the tubular body will cause the balloon element to inflate outwardly.
  • the tubular body serves as both a guide wire and catheter for threading into a vasculature passageway and carrying fluid to inflate the balloon element at the target location.
  • FIG. 1 is a side, fragmented, partially cross- sectional view of one embodiment of a flexible balloon catheter/guide wire formed with cuts, in accordance with the present invention.
  • FIG. 2 is a side, fragmented, partially cross- sectional view of another embodiment of a flexible balloon catheter/guide wire formed with cuts, also in accordance with the present invention.
  • FIG. 1 is a side, fragmented, partially cross- sectional view of a balloon catheter/guide wire 120 made m accordance with the present invention.
  • a pin vise type torqumg chuck 124 is shown attached to a proximal end 128 in the usual manner.
  • the chuck 124 also includes an opening, bore, or luer adapter 132 to allow for introduction of inflating fluid into the interior of the tubular catheter/guide wire 120. (The chuck 124 could be positioned farther toward the distal end of the catheter/guide wire 120, separated from the luer adapter 132. )
  • a wire mandrel 133 Insertable in the hollow of the catheter/guide wire 120 is a wire mandrel 133 which may be made radiopaque to X-ray fluoroscopy to enhance visualization or, if magnetic resonance imaging (MRI) were used, the wire mandrel 133 could be made of a material active for MRI detection such as gadolinium or gadolinium compound, gadolinium encapsulated m a sheath, dysprosium, dysprosium compound or dysprosium encapsulated in a sheath.
  • the purpose of such a wire mandrel would be to enhance visualization of the catheter/guide wire as it is threaded into vasculature or body cavities .
  • the wire mandrel could also be used to change the curvature of the catheter/guide wire 120 as desired by the user.
  • the catheter/guide wire 120 could be formed with a portion of it curved or angled
  • the catheter/guide wire 120 could be formed to be straight and the wire mandrel 133 formed with selected curves so that when the mandrel were inserted into the catheter/guide wire, the mandrel would cause the catheter/guide wire to assume those same curves and when the mandrel were removed, the catheter/guide wire would again straighten.
  • the shape of the catheter/guide wire can be controlled to a certain extent while disposed in vasculature or body cavities.
  • the catheter/guide wire 120 is constructed of nickel titanium alloy and may range m size from about .008 inches to .090 inches m outside diameter, and about .005 inches to .084 inches in inside diameter, and about 175 to 300 cm in length.
  • the catheter/guide wire 120 could also be made of stainless steel, polymers or other flexible materials having suitable strength. Cuts, slots, gaps or openings 34 and 38 are formed in the catheter/guide wire 120 along the length thereof, either by saw cutting (e.g. diamond grit embedded semiconductor dicing blade) , electron discharge machining, laser cutting or etching (for example using the etching process described in U.S. Patent No.
  • Cuts 134 are generally perpendicular or crosswise to the long dimension of the catheter/guide wire. (Various cut patterns may be used, however.) Cuts 138, on the distal end 140 of the catheter/guide wire, are formed to extend through the catheter/guide wire 120 walls to allow escape of fluid introduced into the hollow at the proximal end. This will be explained more later. Formed on the distal end 140 of the catheter/guide wire 120 may be a radiopaque or MRI marker or band 144.
  • the band 144 may be gold or platinum alloy (for X-ray fluoroscopy) or gadolinium or dysprosium, or compounds thereof (for MRI) , and may be formed on the distal end 140 by deposition, wrapping or use of the shape memory alloy (NiTi) effect to "lock" the band around the end
  • the marker 144 is centered inside an expandable balloon 146 (to be discussed momentarily) to show the location of the balloon in the vasculature.
  • the distal end of the hollow of the tubular catheter/guide wire 120 includes a plug 148 for blocking the escape of fluid introduced into the hollow at the proximal end.
  • the plug 148 might also be radiopaque and/or MRI detectable to further facilitate tracking.
  • Joined to the distal end of the catheter/guide wire 120 is a flexible, soft coil tip advantageously made of a radiopaque material such as platinum or a material which is detectable my MRI. This, of course, would allow tracking of the leading distal end of the catheter/guide wire 120 as it is threaded through a vasculature or body cavity.
  • the soft flexibility of the coil tip 152 minimizes the chance of traumatic piercing of body tissue as the catheter/guide wire 120 is inserted into the body.
  • a sleeve 156 Disposed about the tubular portion of the catheter/guide wire 120 is a sleeve 156 which extends from near or at the proximal end snugly about the catheter/guide wire tubular portion to a location just before the cuts 138 (which extend through the walls of the catheter/guide wire 120) and marker 144. At that point, the sleeve 156 widens into a resilient balloon section 146 and then, just before the distal end 140 and the coil tip 152, it again narrows to fit snugly about the distal end.
  • the sleeve 156 is made of a resilient, flexible material such as polyethylene or other commonly used angioplasty balloon materials suitable for dilation of clogged or partially clogged vessels.
  • FIG. 2 shows an alternative embodiment of a balloon catheter/guide wire made in accordance with the present invention.
  • a tubular portion of a catheter/guide wire 200 is made up of two parts 204a and 204b which are telescopically, but fixedly, fitted together at a joint 208.
  • Tubular part 204a comprises the longest part and illustratively is made of stainless steel
  • the tubular part 204b comprises the distal end of the catheter/guide wire 200 and, advantageously, is made of a more flexible shape memory alloy nickel titanium.
  • a plurality of cuts 212 which extend entirely through the tubular sidewall.
  • cuts could also be formed along at least portions of the rest of the length of the catheter/guide
  • a coil 216 Disposed in the hollow at the distal end of the catheter/guide wire 200 is a coil 216 advantageously made of a radiopaque material such as platinum or a material which is MRI detectable.
  • the innermost end of the coil 216a is bunched together to provide a radiographic or MRI identification of the location of a balloon section 220, to be discussed momentarily, by positioning this portion of the coil centrally within the balloon section.
  • the outermost portion 216b of the coil 216 is stretched to provide greater flexibility and softness in the coil to limit the possibility of puncture.
  • a block 224 is disposed in the distal end of the tubular section 204b to prevent the escape of fluid introduced into the proximal end of the catheter/guide wire 200.
  • a sleeve 228 m Disposed about the tubular section 204b is a sleeve 228 m which all but the balloon section 220 fits snugly about the tubular section.
  • the sleeve 228 and balloon section 220 are made of a polyethylene material .
  • a stiffening mandrel 232 is shown inserted into the hollow of the catheter/guide wire 200 at the proximal end to allow for stiffening the catheter/guide wire along the length of the catheter/guide wire occupied by the mandrel.
  • a handle 236 is mounted on the proximal end of the stiffening mandrel 232 and includes a stop 238 to prevent the mandrel from being inserted too far into the catheter/guide wire.
  • the wire mandrel 133 of FIG. 1 could also include a stop.
  • a balloon material suitable for occluding rather than dilating could be provided Such a material includes latex rubber and may be provided at a forward section of the balloon catheter/guide wires of the FIGS, so as to occlude the flow of blood upstream of the location where the angioplasty balloon sections would be utilized to perform angioplasty.
  • the catheter/guide wire has been formed and adapted to serve as a balloon catheter for use, for example, as a predilation catheter in situations such as the existence of a tight stenosis. Because of the thinness of the catheter/guide wire, it is especially suitable for insertion into vasculature having tight confines.
  • the stiffening mandrel allows for reducing the lateral flexibility of the catheter/guide wire to enhance the insertability and threading capability of the catheter/guide wire Because of the low profile of the entire assembly, another balloon catheter could be inserted over the entire assembly for further treatment.

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

Abstract

Appareil à fil de guidage/cathéter à ballon flexible (120) comprenant un corps tubulaire creux, mince de forme allongée, dont la surface extérieure comprend plusieurs coupures (138) espacées entres elles le long d'au moins une partie de la longueur du corps, et certaines d'entre elles traversant l'intérieur du corps tubulaire. Les coupures s'étendent transversalement au corps et sont positionnées pour donner à l'appareil une certaine flexibilité sans réduire pour autant de manière significative la rigidité en torsion. Une section à ballon (146) est disposée autour du corps tubulaire au moins à proximité d'une extrémité distale (140) et autour d'au moins certaines des coupures qui traversent le corps tubulaire, de sorte qu'un fluide introduit dans le creux du corps tubulaire à une extrémité proximale (128) de celui-ci provoquera le gonflement vers l'extérieur de la section à ballon. Cette structure permet à l'appareil de servir à la fois de fil de guidage et de cathéter pour l'enfiler dans un passage vasculaire, et transporter du fluide afin de gonfler la section à ballon au niveau de l'emplacement cible.
PCT/US1997/008640 1996-05-24 1997-05-21 Procede et appareil fil de guidage/catheter a ballon flexible WO1997044086A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU31369/97A AU3136997A (en) 1996-05-24 1997-05-21 Flexible balloon catheter/guide wire apparatus and method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US65376896A 1996-05-24 1996-05-24
US08/653,768 1996-05-24

Publications (1)

Publication Number Publication Date
WO1997044086A1 true WO1997044086A1 (fr) 1997-11-27

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PCT/US1997/008640 WO1997044086A1 (fr) 1996-05-24 1997-05-21 Procede et appareil fil de guidage/catheter a ballon flexible

Country Status (3)

Country Link
AU (1) AU3136997A (fr)
TW (1) TW357090B (fr)
WO (1) WO1997044086A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003047675A2 (fr) * 2001-07-31 2003-06-12 Amir Belson Guide pour catheter flottant comprenant une tige a rigidite variable
US8021329B2 (en) 2004-12-09 2011-09-20 Boston Scientific Scimed, Inc., Catheter including a compliant balloon
US8870790B2 (en) 2002-07-25 2014-10-28 Boston Scientific Scimed, Inc. Medical device for navigation through anatomy and method of making same
US9011511B2 (en) 2009-02-20 2015-04-21 Boston Scientific Scimed, Inc. Balloon catheter
US9023011B2 (en) 2003-03-27 2015-05-05 Boston Scientific Scimed, Inc. Medical device
US9072874B2 (en) 2011-05-13 2015-07-07 Boston Scientific Scimed, Inc. Medical devices with a heat transfer region and a heat sink region and methods for manufacturing medical devices
US9227037B2 (en) 2008-01-03 2016-01-05 Boston Scientific Scimed, Inc. Cut tubular members for a medical device and methods for making and using the same
US9339632B2 (en) 2006-09-27 2016-05-17 Boston Scientific Scimed, Inc. Catheter shaft designs
US9375234B2 (en) 2006-12-15 2016-06-28 Boston Scientific Scimed, Inc. Medical device including structure for crossing an occlusion in a vessel
US9445784B2 (en) 2005-09-22 2016-09-20 Boston Scientific Scimed, Inc Intravascular ultrasound catheter
US9808595B2 (en) 2007-08-07 2017-11-07 Boston Scientific Scimed, Inc Microfabricated catheter with improved bonding structure
US9901706B2 (en) 2014-04-11 2018-02-27 Boston Scientific Scimed, Inc. Catheters and catheter shafts
US11351048B2 (en) 2015-11-16 2022-06-07 Boston Scientific Scimed, Inc. Stent delivery systems with a reinforced deployment sheath

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4998923A (en) * 1988-08-11 1991-03-12 Advanced Cardiovascular Systems, Inc. Steerable dilatation catheter
US5387235A (en) * 1991-10-25 1995-02-07 Cook Incorporated Expandable transluminal graft prosthesis for repair of aneurysm

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4998923A (en) * 1988-08-11 1991-03-12 Advanced Cardiovascular Systems, Inc. Steerable dilatation catheter
US5387235A (en) * 1991-10-25 1995-02-07 Cook Incorporated Expandable transluminal graft prosthesis for repair of aneurysm

Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003047675A3 (fr) * 2001-07-31 2003-10-09 Amir Belson Guide pour catheter flottant comprenant une tige a rigidite variable
WO2003047675A2 (fr) * 2001-07-31 2003-06-12 Amir Belson Guide pour catheter flottant comprenant une tige a rigidite variable
US8932235B2 (en) 2002-07-25 2015-01-13 Precision Vascular Systems, Inc. Medical device for navigation through anatomy and method of making same
US8939916B2 (en) 2002-07-25 2015-01-27 Precision Vascular Systems, Inc. Medical device for navigation through anatomy and method of making same
US8936558B2 (en) 2002-07-25 2015-01-20 Precision Vascular Systems, Inc. Medical device for navigation through anatomy and method of making same
US8870790B2 (en) 2002-07-25 2014-10-28 Boston Scientific Scimed, Inc. Medical device for navigation through anatomy and method of making same
US8900163B2 (en) 2002-07-25 2014-12-02 Precision Vascular Systems, Inc. Medical device for navigation through anatomy and method of making same
US8915865B2 (en) 2002-07-25 2014-12-23 Precision Vascular Systems, Inc. Medical device for navigation through anatomy and method of making same
US9023011B2 (en) 2003-03-27 2015-05-05 Boston Scientific Scimed, Inc. Medical device
US9592363B2 (en) 2003-03-27 2017-03-14 Boston Scientific Scimed, Inc. Medical device
US10207077B2 (en) 2003-03-27 2019-02-19 Boston Scientific Scimed, Inc. Medical device
US9433762B2 (en) * 2004-12-09 2016-09-06 Boston Scientific Scimed, Inc. Catheter including a compliant balloon
US8540668B2 (en) 2004-12-09 2013-09-24 Boston Scientific Scimed, Inc. Catheter including a compliant balloon
US8021329B2 (en) 2004-12-09 2011-09-20 Boston Scientific Scimed, Inc., Catheter including a compliant balloon
US20140012195A1 (en) * 2004-12-09 2014-01-09 Boston Scientific Scimed, Inc. Catheter including a compliant balloon
US9445784B2 (en) 2005-09-22 2016-09-20 Boston Scientific Scimed, Inc Intravascular ultrasound catheter
US9339632B2 (en) 2006-09-27 2016-05-17 Boston Scientific Scimed, Inc. Catheter shaft designs
US10315018B2 (en) 2006-09-27 2019-06-11 Boston Scientific Scimed Inc. Catheter shaft designs
US9375234B2 (en) 2006-12-15 2016-06-28 Boston Scientific Scimed, Inc. Medical device including structure for crossing an occlusion in a vessel
US9808595B2 (en) 2007-08-07 2017-11-07 Boston Scientific Scimed, Inc Microfabricated catheter with improved bonding structure
US9227037B2 (en) 2008-01-03 2016-01-05 Boston Scientific Scimed, Inc. Cut tubular members for a medical device and methods for making and using the same
US9011511B2 (en) 2009-02-20 2015-04-21 Boston Scientific Scimed, Inc. Balloon catheter
US9072874B2 (en) 2011-05-13 2015-07-07 Boston Scientific Scimed, Inc. Medical devices with a heat transfer region and a heat sink region and methods for manufacturing medical devices
US9901706B2 (en) 2014-04-11 2018-02-27 Boston Scientific Scimed, Inc. Catheters and catheter shafts
US11351048B2 (en) 2015-11-16 2022-06-07 Boston Scientific Scimed, Inc. Stent delivery systems with a reinforced deployment sheath

Also Published As

Publication number Publication date
AU3136997A (en) 1997-12-09
TW357090B (en) 1999-05-01

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