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WO1999039659A2 - Catheter a ballon avec cavite pour mise en place d'un stent - Google Patents

Catheter a ballon avec cavite pour mise en place d'un stent Download PDF

Info

Publication number
WO1999039659A2
WO1999039659A2 PCT/US1999/002639 US9902639W WO9939659A2 WO 1999039659 A2 WO1999039659 A2 WO 1999039659A2 US 9902639 W US9902639 W US 9902639W WO 9939659 A2 WO9939659 A2 WO 9939659A2
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
balloon
stent
inflation
shaft
Prior art date
Application number
PCT/US1999/002639
Other languages
English (en)
Other versions
WO1999039659A3 (fr
Inventor
Gary Gershony
Original Assignee
Vascular Solutions
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 Vascular Solutions filed Critical Vascular Solutions
Priority to AU26616/99A priority Critical patent/AU2661699A/en
Publication of WO1999039659A2 publication Critical patent/WO1999039659A2/fr
Publication of WO1999039659A3 publication Critical patent/WO1999039659A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts

Definitions

  • This invention relates to catheters and more particularly, dilatation balloon catheters for stent implantation.
  • a first dilatation balloon catheter is percutaneously introduced into the patient's vasculature under fluoroscopic control.
  • the first balloon catheter generally incorporates an undersized balloon that is used to pre-dilate or create a channel in which to pass the stent through without damaging the vasculature.
  • the balloon is usually selected at a diameter that is approximately 0.5 mm less in diameter than that of the artery it will be dilating.
  • the first catheter is removed.
  • a second dilatation balloon catheter incorporating a low pressure balloon and surrounding stent, is percutaneously introduced through the pre-dilated passageway to reach the desired location and lightly embed the stent within the vasculature.
  • the low pressure balloon is removed, and a high pressure balloon is inserted.
  • the high pressure balloon is inflated by pneumatic pressure to dilate the stenosis, expand and implant the stent, and thereby relieve the obstruction to blood flow.
  • the high pressure balloon is then deflated and removed.
  • Conventional dilatation balloon catheters for stent placement use balloons and accompanying stents that are maintained to the exterior diameter of the catheter body and that are crimped to or attached to the catheter in some fashion that enables undesirable sliding of the stent during positioning.
  • the sliding of the stent can result in improper placement of the stent and potential damage to a patient's vascular structure. Catastrophe can occur if the stent slides completely off the balloon catheter during insertion.
  • a balloon and stent that is maintained to the exterior diameter of the catheter body adds additional and unwanted bulk to the profile of the catheter which may cause undesirable stretching and/or tearing of the vasculature.
  • a balloon catheter with a stent recess or retention means that can perform the function of two catheters, e.g. widening passageways and dilating a stenosis, as well as provide protection to the stent to prevent the sliding and /or complete loss of the stent during placement, and maintain a slim profile during insertion of the catheter.
  • the balloon catheter with the stent placement recess generally comprises a catheter shaft that is defined by a proximal and distal end, and an inner and outer diameter. Intermediate the proximal and distal ends is a recess.
  • the recess is defined by an elongate base and sides that are approximately perpendicular to the elongate base. The length of the sides extends between the elongate base and the outer diameter of the catheter shaft.
  • An inner shaft is placed inside the catheter shaft and creates an inflation lumen between the inner shaft and the catheter shaft.
  • a balloon is secured to the catheter shaft so as to receive inflation fluid from the inflation lumen. The balloon is maintained within the recess when it is not inflated.
  • a stent is wrapped about the balloon and is also maintained within the recess when the balloon is not inflated.
  • Fig. 1 depicts a side sectional view of a balloon catheter with stent placement recess of the present invention with the balloon inflated.
  • Fig. 2 depicts a side sectional view of the balloon catheter with stent placement recess of the present invention with the balloon deflated.
  • Balloon catheter 10 with stent placement recess generally comprises a catheter shaft 16, an inner shaft 18, a balloon 20 and stent 22.
  • Catheter shaft 16 has a proximal end portion 26 and a distal end portion 28.
  • the catheter shaft 16 diameter is preferably less than or equal to about three French, e.g., 3F.
  • Catheter shaft 16 surrounds an inner shaft 18.
  • the space between catheter shaft 16 and inner shaft 18 comprises an inflation lumen 30 while the space interior to inner shaft 18 comprises a guidewire lumen 31.
  • Balloon 20 is secured to catheter shaft 16 so as to receive inflation fluid from inflation lumen 30.
  • Stent 22 is wrapped about balloon 20.
  • Balloon 20 is preferably a high pressure balloon, capable of inflation to sixteen or more atmospheres.
  • Recess 32 incorporates an elongate base portion 34, which is preferably in the range of 6-40 mm in length, and perpendicular side portions 36. Balloon 20 and stent 22 are maintained within said recess and generally do not extend beyond the maximum diameter of the catheter shaft 16 while the catheter 10 is being positioned within the vasculature, or during the times of non-inflation.
  • the ability of recess 32 to retain balloon 20 and stent 22 during the non-inflation period prevents stent 22 from sliding relative to balloon 20 and also prevents improper placement of stent 22 within the vasculature.
  • balloon 20 and stent 22 within the area of a retention means having a smaller catheter profile than adjacent catheter wall portions, such as recess 32, prevents unwanted stretching and tearing of the vasculature that may otherwise occur using a balloon and stent that extend the exterior diameter of the catheter during the non-inflation period.
  • balloon catheter 10 The preferred procedural use of balloon catheter 10 is as follows: (1) a first balloon catheter, utilizing an undersized balloon, is used to pre- dilate or create a channel within the vasculature to allow for passage of stent balloon catheter 10 without damage to the vasculature; and (2) balloon catheter 10 with stent 22 is introduced to the pre-dilated passageway and inserted until stent 22 is in the desired location at which time balloon 20 is expanded by pneumatic pressure to dilate the stenosis, and to expand and implant stent 22. Balloon 20 is then deflated and removed. Noticeably, the preferred procedural use of balloon catheter 10 with recessed stent 22 has eliminated one significant step of the standard, prior art procedure.
  • the intermediate step of using a low pressure balloon to pre-position stent 22 prior to use of the high pressure balloon to embed stent 22 could additionally be reduced to a single step if catheter 10 and recessed stent 22 were of a low enough profile to eliminate the need for a pre-dilation catheter.
  • balloon 20 is retained within a recess 32.
  • alternative embodiments of the invention encompass the concept of stent 22 being retained relative to the catheter shaft 16 by any type of effective indentation, e.g. built-up portions around the circumference of the catheter shaft 16, located at each end of stent 22 to retain stent 22.
  • the use of built-up portions may undesirably expand the overall diameter of the catheter and as such, the appropriate embodiment should be chosen in view of the application at hand.
  • balloon catheter with recess for stent 10 may be used as a pre-dilation catheter with or without the stent 22 present.

Landscapes

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

Abstract

Un cathéter à ballon, avec cavité pour mise ne place d'un stent, comprend une tige de cathéter présentant une cavité définie par une base allongée et des côtés sensiblement perpendiculaires à la base. Les côtés de la cavité s'étendent entre la base allongée et le diamètre extérieur de la tige du cathéter. Un ballon gonflable est fixé à la tige du cathéter et est maintenu dans la cavité lorsqu'il n'est pas gonflé. Un stent, enroulé autour du ballon, est également maintenu dans la cavité lorsque le ballon n'est pas gonflé. La cavité ménagée dans la tige du cathéter et son aptitude à maintenir le ballon et le stent empêchent tout glissement du stent par rapport au ballon et, de ce fait, une mise en place inappropriée du stent dans le système vasculaire. La cavité maintient également le profil mince de la tige du cathéter et empêche tout étirement ou déchirement indésirable du système vasculaire par le cathéter avant la mise en place du stent.
PCT/US1999/002639 1998-02-09 1999-02-09 Catheter a ballon avec cavite pour mise en place d'un stent WO1999039659A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU26616/99A AU2661699A (en) 1998-02-09 1999-02-09 Balloon catheter with stent placement recess

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US7406398P 1998-02-09 1998-02-09
US60/074,063 1998-02-09

Publications (2)

Publication Number Publication Date
WO1999039659A2 true WO1999039659A2 (fr) 1999-08-12
WO1999039659A3 WO1999039659A3 (fr) 2000-08-24

Family

ID=22117482

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/002639 WO1999039659A2 (fr) 1998-02-09 1999-02-09 Catheter a ballon avec cavite pour mise en place d'un stent

Country Status (2)

Country Link
AU (1) AU2661699A (fr)
WO (1) WO1999039659A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003000334A1 (fr) 2001-06-26 2003-01-03 Concentric Medical, Inc. Catheter a ballonnet

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4762128A (en) * 1986-12-09 1988-08-09 Advanced Surgical Intervention, Inc. Method and apparatus for treating hypertrophy of the prostate gland
US5372600A (en) * 1991-10-31 1994-12-13 Instent Inc. Stent delivery systems
US5429605A (en) * 1994-01-26 1995-07-04 Target Therapeutics, Inc. Microballoon catheter
US5733299A (en) * 1994-10-20 1998-03-31 Cordis Corporation Two balloon catheter
US5810871A (en) * 1997-04-29 1998-09-22 Medtronic, Inc. Stent delivery system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003000334A1 (fr) 2001-06-26 2003-01-03 Concentric Medical, Inc. Catheter a ballonnet
EP1409064A4 (fr) * 2001-06-26 2007-04-25 Concentric Medical Inc Catheter a ballonnet

Also Published As

Publication number Publication date
AU2661699A (en) 1999-08-23
WO1999039659A3 (fr) 2000-08-24

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