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EP0646031A1 - Catheter gonflable a double fonction de dilatation et de perfusion - Google Patents

Catheter gonflable a double fonction de dilatation et de perfusion

Info

Publication number
EP0646031A1
EP0646031A1 EP93914410A EP93914410A EP0646031A1 EP 0646031 A1 EP0646031 A1 EP 0646031A1 EP 93914410 A EP93914410 A EP 93914410A EP 93914410 A EP93914410 A EP 93914410A EP 0646031 A1 EP0646031 A1 EP 0646031A1
Authority
EP
European Patent Office
Prior art keywords
infusion
catheter
lumen
balloon
dilatation
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP93914410A
Other languages
German (de)
English (en)
Inventor
B. Daniel Burleigh
Leon R. Lyle
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mallinckrodt Inc
Original Assignee
Mallinckrodt Medical 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 Mallinckrodt Medical Inc filed Critical Mallinckrodt Medical Inc
Publication of EP0646031A1 publication Critical patent/EP0646031A1/fr
Withdrawn legal-status Critical Current

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
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0454—Redundant cuffs
    • A61M16/0456—Redundant cuffs one cuff within another
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0481—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids through the cuff wall
    • 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
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
    • 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
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Definitions

  • the present invention relates to a catheter which can be sequentially used to perform angioplasty and then the administration of therapeutic agents.
  • the present invention relates to a catheter having both dilatation and infusion balloons, wherein the infusion balloon has pores optimally sized to allow infusion of insoluble therapeutic agents.
  • Percutaneous transluminal angioplasty (PTA) procedures typically are performed using a guiding catheter which may be percutaneously introduced into the cardiovascular system of the patient through the brachial or femoral arteries and" advanced therein until the tip thereof is properly positioned in the ostium of the afflicted artery.
  • a guidewire and a dilatation balloon catheter are then introduced through the guiding catheter, the guidewire being disposed within an inner lumen of the balloon catheter. The guidewire and balloon are advanced until the dilatation balloon is properly located within the area of lesion to be treated.
  • the dilatation balloon is inflated to a predetermined size using a radiopaque liquid, such as contrast medium, in order to radially compress the atherosclerotic plaque of the lesion against the inside of the artery wall and thereby dilate the lumen of the artery.
  • the dilatation balloon is then deflated and the balloon catheter removed so that blood flow may be resumed through the dilated artery.
  • Another means of treating stenosed arteries is through the administration of drugs such as anticoagulants, anti- proliferatives or gene transfection reagents. These drugs are commonly delivered to the stenosed artery through an infusion catheter which includes small holes formed through the catheter wall or through the wall of a balloon formed on the catheter, so that the drug may be allowed to contact with the area of treatment over a prolonged time period.
  • insoluble particles such as, microspheres, liposomes, viruses, viral like particles, or other insoluble or colloidal formulations which provide for more controlled release of the therapeutic agent.
  • insoluble particles exhibit improved tissue residence profiles, and therefore, may provide more favorable treatment results than primarily soluble agents.
  • the objects of the present invention are accomplished by providing a catheter having a two concentrically formed balloons, the inner most balloon capable of performing dilatation, and the outer balloon capable of delivering therapeutic drugs.
  • the outer balloon comprises an infusion balloon having infusion pores optimally sized to allow for infusion of soluble therapeutic agents to the treatment site.
  • Fig. 1 is a plan view of a catheter according to a first embodiment of the present invention.
  • Fig. 2 is a cross-sectional view of a catheter according to the first embodiment of the present invention, taken along line A-A of Fig. 1.
  • Fig. 3 is a plan view of a catheter according to a second embodiment of the present invention.
  • Fig. 4 is a cross-sectional view of a catheter according to the present invention, taken along line B-B of Fig. 3.
  • Fig. 5 is a cross-sectional view of a catheter according to the present invention, taken along line C-C of Fig. 3.
  • Fig. 1 is a plan view of a catheter according to a first embodiment of the present invention.
  • the catheter generally designated by reference numeral 10, includes a multi-lumen shaft 20, one lumen of which serves as a guidewire lumen, a second lumen of which serves as a dilatation balloon inflation lumen, and a third lumen of which serves as a therapeutic drug infusion lumen.
  • the various lumens of the shaft 20, according to this embodiment are formed in a concentric configuration ⁇ .
  • a guidewire lumen 35 extends the entire length of the catheter 10, ending at the distal end 30.
  • the guidewire lumen 35 is surrounded by a dilatation balloon inflation lumen 45, which extends form a proximal end of the catheter 10, to a dilatation balloon 40, formed near the distal end 30.
  • the dilatation balloon inflation lumen 45 is surrounded by an infusion lumen 55, which extends from a proximal end of the catheter 10, to an infusion balloon 50, formed near the distal end 30.
  • the infusion balloon 50 includes infusion pores 58, which allow for the infusion of therapeutic agents to a treatment site.
  • the infusion pores 58 normally have a diameter in the range of 15 to 75 microns, preferably about 25 to 50 microns. Infusion pores 58, having such a diameter allow for infusion of soluble therapeutic agents. Infusion of large numbers or a high concentration of insoluble particles having a particle size greater than 1 microns in diameter may cause problems of clogging or partial blocking of the infusion pores 58, unless special measures are taken.
  • the pore size of infusion pores 58 may be increased so as to allow the administration of insoluble particles. Pore sizes up to 250 microns, preferable about 100 microns in diameter may be successfully employed in the infusion of large numbers or a high concentration of insoluble therapeutic agents having a particle size up to 25 microns in diameter. However, when relatively large pore sizes are utilized, optimal hydrostatic pressure may be compromised which could result in inadequate perfusion. This problem may be overcome and optimal conditions for hydrostatic pressure can be controlled by regulating the number of infusion pores 58.
  • Fig. 3 is a plan view of a catheter according to a second embodiment of the present invention.
  • the catheter generally designated by reference numeral 100, differs from the catheter shown in Fig. 1 only by the provision of a main shaft 120, having lumens in a side-by-side configuration, attached to a balloon shaft 125, having lumens in a concentric configuration.
  • the main shaft 120, and balloon shaft 125, are attached at joint portion 160.
  • the main shaft 120 includes a guidewire lumen 135, a balloon dilatation inflation lumen 145, and an infusion lumen 155, each of which extend the entire length of the main shaft 120, from a proximal end of catheter 100, to the joint portion 160.
  • the lumens 135, 145 and 155 are formed in a side-by-side configuration.
  • the balloon shaft 125 includes concentrically formed lumens.
  • a guidewire lumen 135' extends the entire length of the balloon shaft 125, from the joint portion 160, to the distal end 130, of catheter 100.
  • the guidewire lumen 135' is surrounded by a dilatation balloon inflation lumen 145', which extends from the joint portion 160, to a dilatation balloon 140, formed near the distal end 130.
  • the dilatation balloon inflation lumen 145' is surrounded by in infusion lumen 155' which extends from the joint portion 160, to an infusion balloon 150, formed near the distal end 130.
  • the infusion balloon 150 includes infusion pores 158, which allow for the infusion of therapeutic agents to a treatment site.
  • the infusion pores 158 again have a diameter in the range of 15 to 75 microns, preferably about 25 to 50 microns, to allow for infusion of soluble therapeutic agents. As noted above, the diameter and number of infusion pores may be adjusted to allow for infusion of insoluble particles.
  • the main shaft 120, and balloon shaft 125 may be joined by any suitable method such that the corresponding lumens of the two shafts are joined.
  • guidewire lumens 135, and 135' are joined; dilatation balloon inflation lumens 145 and 145' are joined; and infusion lumens 155 and 155' are joined.
  • the joining should provide a continuous lumen from the proximal end of the catheter 100, to the distal end 130, dilatation balloon 140, or infusion lumen 150, as appropriate.
  • the catheter according to the present invention is very advantageous in helping to prevent reocclusion or stenosis of arteries following a balloon angioplasty procedure.
  • This is extremely advantageous in saving time and energy in assuring exact placement and in avoiding excessive damage to the arterial structure of a patient.
  • This construction is also advantageous in reducing "dead volumn" and conserving expensive drugs by reducing waste per dose.
  • the catheter according to the present invention is very advantageous because it allows both angioplasty and drug infusion to be carried out at their different optimal inflation pressures.
  • the catheter according to the present invention is very advantageous in allowing for the infusion of insoluble therapeutic agents.
  • the relatively large infusion pores provided through the infusion balloon of the catheter according to the present invention allow such insoluble therapeutic agents to be delivered directly to the treatment site. This is advantageous because insoluble therapeutic agents exhibit improved tissue residence profiles and thus more favorable treatment characteristics.
  • Use of the catheter according to the present invention can greatly reduce the risk of restenosis of a dilated artery by providing treatment thereof in a more expeditious manner than possible with prior art catheters.
  • catheter according to the present invention can enable delivery of insoluble therapeutic agents directly to the treatment site, such insoluble agents providing more beneficial treatment results and characteristics.

Landscapes

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

Abstract

L'invention se rapporte à un cathéter pouvant servir à la fois à un procédé d'angioplastie au moyen d'un ballon de dilatation (40) et à l'administration de médicaments thérapeutiques au moyen d'un ballon de perfusion (50). Le cathéter décrit par l'invention présente des avantages étant donné qu'il élimine la nécessité de retirer et de réintroduire des cathéters séparés ou de repositionner le même cathéter pour effectuer les opérations de dilatation et de perfusion. L'invention concerne également un cathéter gonflable à double fonction de dilatation et de perfusion, dans lequel le ballon de perfusion (50) peut introduire par perfusion des agents thérapeutiques insolubles dans le site de traitement, ce qui présente des avantages étant donné que les agents insolubles comportent des profiles améliorés de séjour dans les tissus, ainsi que des caractéristiques de traitement plus bénéfiques.
EP93914410A 1992-06-12 1993-06-08 Catheter gonflable a double fonction de dilatation et de perfusion Withdrawn EP0646031A1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US89763592A 1992-06-12 1992-06-12
US897635 1992-06-12
US2692993A 1993-03-05 1993-03-05
US26929 1993-03-05
PCT/US1993/005396 WO1993025265A1 (fr) 1992-06-12 1993-06-08 Catheter gonflable a double fonction de dilatation et de perfusion

Publications (1)

Publication Number Publication Date
EP0646031A1 true EP0646031A1 (fr) 1995-04-05

Family

ID=26701831

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93914410A Withdrawn EP0646031A1 (fr) 1992-06-12 1993-06-08 Catheter gonflable a double fonction de dilatation et de perfusion

Country Status (5)

Country Link
EP (1) EP0646031A1 (fr)
JP (1) JPH07507704A (fr)
AU (1) AU4408193A (fr)
CA (1) CA2136839A1 (fr)
WO (1) WO1993025265A1 (fr)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5368566A (en) * 1992-04-29 1994-11-29 Cardiovascular Dynamics, Inc. Delivery and temporary stent catheter having a reinforced perfusion lumen
JPH0751379A (ja) * 1993-06-24 1995-02-28 Cardiovascular Dynamics Inc 注入カテーテル及び脈管内部位処置方法並びにカテーテル製造方法
US5344402A (en) * 1993-06-30 1994-09-06 Cardiovascular Dynamics, Inc. Low profile perfusion catheter
WO1997041916A1 (fr) * 1996-05-03 1997-11-13 Emed Corporation Mise en place d'un extenseur coronarien combinee avec un apport local d'un agent
US6099506A (en) 1997-09-26 2000-08-08 Macoviak; John A. Introducer and perfusion cannula
AU9510398A (en) * 1997-09-26 1999-04-12 Cardeon Corporation Main stage catheterization instrument
US7077836B2 (en) * 2000-07-21 2006-07-18 Vein Rx, Inc. Methods and apparatus for sclerosing the wall of a varicose vein
GB2426457A (en) * 2005-05-26 2006-11-29 Leonid Shturman Balloon angioplasty device with distal protection capability
US7789915B2 (en) 2005-08-31 2010-09-07 Vance Products Incorporated Stent for implantation
US9498356B2 (en) 2012-12-19 2016-11-22 Cook Medical Technologies, LLC Flexible stent and delivery system
US9763814B2 (en) 2014-10-24 2017-09-19 Cook Medical Technologies Llc Elongate medical device
EP3429513A4 (fr) 2016-03-18 2020-03-18 Procept Biorobotics Corporation Procédés et systèmes très peu invasifs pour l'hémostase d'un volume tissulaire hémorragique clos

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4693243A (en) * 1983-01-14 1987-09-15 Buras Sharon Y Conduit system for directly administering topical anaesthesia to blocked laryngeal-tracheal areas
US4994033A (en) * 1989-05-25 1991-02-19 Schneider (Usa) Inc. Intravascular drug delivery dilatation catheter

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9325265A1 *

Also Published As

Publication number Publication date
AU4408193A (en) 1994-01-04
JPH07507704A (ja) 1995-08-31
CA2136839A1 (fr) 1993-12-23
WO1993025265A1 (fr) 1993-12-23

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