CA2133698C - Interventional catheter - Google Patents

Interventional catheter

Info

Publication number
CA2133698C
CA2133698C CA002133698A CA2133698A CA2133698C CA 2133698 C CA2133698 C CA 2133698C CA 002133698 A CA002133698 A CA 002133698A CA 2133698 A CA2133698 A CA 2133698A CA 2133698 C CA2133698 C CA 2133698C
Authority
CA
Canada
Prior art keywords
catheter
balloon
catheter tube
inner layer
tube
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.)
Expired - Fee Related
Application number
CA002133698A
Other languages
French (fr)
Other versions
CA2133698A1 (en
Inventor
Gerhard Kastenhofer
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.)
Schneider Europe GmbH
Original Assignee
Schneider Europe GmbH
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=8213374&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2133698(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Schneider Europe GmbH filed Critical Schneider Europe GmbH
Publication of CA2133698A1 publication Critical patent/CA2133698A1/en
Application granted granted Critical
Publication of CA2133698C publication Critical patent/CA2133698C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1034—Joining of shaft and 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B29C48/10—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels flexible, e.g. blown foils
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/16—Articles comprising two or more components, e.g. co-extruded layers
    • B29C48/18—Articles comprising two or more components, e.g. co-extruded layers the components being layers
    • 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
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A61M2025/0046—Coatings for improving slidability
    • A61M2025/0047—Coatings for improving slidability the inner layer having a higher lubricity
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2009/00—Layered products
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters

Abstract

An interventional catheter for angioplasty and the like, comprising a catheter tube 1 formed of two superposed layers 2 and 3 of materials different from one another.
The inner layer 2 is comprised of a low friction non kinkable material to avoid risk of clogging of a guide wire 11 in the longitudinal lumen 12. The outer layer 3 is comprised of a material with higher friction coefficient than the material forming the inner layer. The balloon 4 is welded at its distal end 5 to the outer layer 23 of the catheter tube. The proximal end 6 of the balloon 4 is welded to a tube 7 surrounding the catheter tube 1.

Description

~ 3 3 ~ ~ $ ~

This invention relates to an interventional catheter comprising a catheter tube having two superposed layers of materials secured in relation to one another and with mechanical properties differing from one another, 5 a longitudinal lumen in said catheter tube for the sli-ding fit of a guide wire, and a balloon with a proximal end and a distal end, whereby the distal end sealingly surrounds said catheter tube, whereby the catheter tube has an inner layer forming the longitudinal lumen and 10 an outer layer forming the outer surface of the catheter tube.

Over the wire catheters are now widely used for interven-tions such as percutaneous transluminal angioplasty.
15 A problem with these catheters is that the guide wire may clog into the longitudinal lumen of the catheter;
as a result, the guide wire may follow the balloon upon withdrawal thereof after the inflation procedure, thereby making it necessary to re-insert the guide wire into 20 the treated area of the blood vessel for re-positioning a balloon therein in case a second inflation is needed.
Apart of this, the catheter has to achieve an acceptable compromise between the requirements of some stiffness to assure good pushability and of some flexibility to 25 assure kink resistance. In addition, the catheter has to permit safe attachment of the balloon to the catheter tube.

The document WO 92/11893 describes an intra-aortic bal-30 loon apparatus comprising a hollow catheter in which is located an elongated member forming a central lumen extending out of the catheter at the distal end thereof.
An aortic pumping balloon is positioned over the elonga-ted member; the distal end of the balloon is bonded 35 to a tip affixed to the distal end of the elongated
2 --member, and its proximal end is bonded to the distal end of the catheter. In order to achieve a balance of flexibility and support and to avoid kinking, the elonga-ted member is formed of an inner layer comprised of a soft elastomeric material to impart flexibility to the tubing, and the outer layer is comprised of a hard plastic material to impart structural support to the elongated member. The combination of these two layers is made to achieve a very durable and flexible structure 10 exhibiting a low kink radius. This balloon apparatus cannot be loaded with a guidewire and moved into tortuous vessels with the guidewire loaded inside the elongated tube. The friction between guidewire and the elongated member increases distinctively when the elongated member is shaped into curves. The above procedure would therefo-re risk that the spiral wound guidewire could be captured in the soft elastomeric plastic material of the inner layer of the elongated member. Although the outer layer of the elongated member that is coextruded onto the 20 inner layer is formed from nylon, a material which is directly weldable to a wide variety of materials, this balloon apparatus cannot be introduced into narrow ves-sels or narrow stenoses nor can it be passed through narrow punctures to enter the blood vessels. This is because of the relatively large profile of the folded balloon. The large profile is due to the distal fixture of the balloon to the elongated member. The ballon is bonded to an intermediate tip element which in turn is bonded to the elongated member.
US Patent N~ 4,323,071 describes a combination guiding catheter assembly and dilating catheter assembly. The guiding catheter assembly comprises a first flexible tubular member formed of a material with low coefficient of friction and high flexibility; as this first tubular member is too flexible to serve as a guiding catheter A~ 75490-5 2~-j3~

~_ - 3 -because it could not be properly manipulated in the body of a patient, a second tubular member made of a heat shrinkable tubing is provided to encase the first tubular member. The distal end of this assembly is pre-shaped to form a shape corresponding to the standardcoronary catheter and the proximal end of the assembly is provided with attachment means to provide a leak-proof adhesive-free connection. The dilating catheter assembly is disposed within the guiding catheter assembly and 10 comprises a first tubular member coaxially disposed within a second tubular member having formed thereon a balloon at its distal end, both these tubular members being made of shrink tubing; an annular flow passage between the first and second tubular members allows 15 introduction of fluid into the balloon for inflation thereof. The proximal end of this assembly is inserted in an adapter body for connection to an appropriate syringe system. A dilator consisting of a flexible plas-tic tube with a teflon coated guide wire therein is 20 used to position the guiding catheter assembly in the proper location. Within this frame, the guide wire is first inserted conventionnally into the blood vessel;
the dilator is then positioned in the guiding catheter assembly to straighten it, and the dilator and guiding 25 catheter are passed over the guide wire into the blood vessel; when the guiding catheter is in the proper loca-tion, the dilator and guide wire are withdrawn from the guiding catheter and the dilating catheter assembly can be inserted into the guiding catheter assembly, 30 which operation is facilitated by the low coefficient of friction of the first tubular member of the guiding catheter assembly. A small guide wire may be utilized if necessary to precisely position the balloon of the dilating catheter assembly; if so, this small guide 35 wire has to be inserted into the first tubular member of the dilating catheter assembly so that it extends ~from the distal portion thereof. This guide wire may be removed once the balloon is in the proper location.
This publication, i. e. U. S. Patent No. 4,323,071, shows a catheter shaft made from a composite material that is achieved by heat shrinking. The material for the inner layer of the composite material is selected from materials rendering low friction. Any instrument inserted into a catheter shaft made from this composite material can easily be moved inside the shaft even after the shaft has been bent and is ke~t in narrow curves. The shaft for the dilataticn balloon catheter shown in this publication does not use composite material for its construction. It uses conventional material in one single layer..
Because the balloon must be welded or otherwise securely bonded to the catheter shaft to withstand the extraordinary high inflation pressures used in ~ngioplasty, the shaft material for this dilatation balloon catheter has to beselected for good bond characteristics and cannot be selected for good friction characteristics. Therefore this catheter still presents the problem that in tortuous vessels, when the catheter shaft has to follow numerous bends of the vessel, the guidewire can be captured in the shaft. This is specifically trouklesome since the dilatation catheter has to advance much deeper into the branched vessel system than the guiding catheter which in this publication is shown as made from composite material. For a dilatation catheter the length of the friction creating shaft is longer than the shaft of the guiding catheter and addition-ally the dilatation catheter shaft is exposed to more vessel curves.
The purpose of this invention is to present an inter-ventional low profile balloon catheter that can be moved intotortuous vessels with a guidewire inside the catheter without the risk of the guidewire being captured or clogging in the catheter.
To this effect, the invention provides an inter-ventional catheter comprising a catheter tube having two superposed layers of materials secured in relation to one another and with mechanical properties differing from one ~ 75490-5 'i~

?~ ~ ~ 3 6 ~ ~
~another, a longitudinal lumen in said catheter tube for the sliding fit of a guidewir-e, and a balloon with a proximal end and a distal end, said distal end sealingly surrounding said catheter tube, whereby the catheter tube has an inner layer forming the longitudinal lumen and an outer layer forming the outer surface of the catheter tube, wherein the inner layer is formed of a material with lower friction coefficient than the material forming the outer layer, the inner layer is a poly-ethylene, the outer layer is a polyamide, and the distal end of the balloon is welded to the outer polyami~ layer of the catheter tube.
In that way, there is no more risk of having the guidewire clogging in the longitudinal lumen of the catheter tube, in particular upon withdrawal of the balloon. Withdrawal and repositioning of a balloon for repeated inflation is there-fore rapid, safe and precise, because during withdrawal of the balloon the guidewire can be left in place with the tip of the guidewire at the site cf the treatment in the vessel system.
As the inner layer forming the longitudinal lumen is separated from the balloon by the outer layer, the choice may be made towards materials having the most appropriate friction and kink resistance coefficients, while safe attachment of the balloon may be made at will on an outer layer of the catheter tube which may be chGsen without being influenced by the properties of the inner layer.
The inner layer and the outer layer may be congruent in length so that the catheter shaft can be produced in long tubes which are cut intG length to form the individual catheter tube.
Where the two layers of the catheter are produced by extruding the outer layer over the inner layer, a specifically reliable catheter tube is formed in a continuous process. To heat shrink the outer layer onto the inner layer would not allow a continuous process because of the presence of an inner core inside the inner layer. This core has to take up the radial pressure during the heat shrinking process and has to be removed after heat shrinking.

;~ ~
~A 75490-5 B ~ ~
Welding of the balloon ~aterial to the outer layer of the catheter tube allows the design of balloon catheters that withstand the extraordinary high inflation pressures used in angioplasty so that these catheters also show the low clogging risk and the low profile given by the invention.
In a preferred form of the invention, the inner layer forming the longitudinal lumen of the catheter tube is made of a high density polyethylene to assure an extremely low friction coefficient and an appropriate kink resistance coefficient.
Making the outer layer of a polyamideassures easy welding of the balloon and a good stiffness at that level.
These and other features will become readily apparent from the following detailed description with reference to the accompanying drawings which show, diagrammatically and by way of example only, a preferred embodiment of the invention.
Fig. 1 is a longitudinal cut out of this embodiment.
Fig. 2 is a section according to line I-I of Fig. 1.
The interventional catheter shown in Figs. 1 and 2 comprises a catheter tube 1 which is formed, in this embodiment, of two superposed continuous layers 2 and 3 extending all over the length of the tube l; this tubing, which may be achieved by the known co-extrusion technology, i. e. by extruding the outer layer over the inner layer, is comprised of a polyethylene, preferably a high density polyethylene, for the inner layer 2, and 2~336;~, 3 .i ,.. .
_ - 7 of a polyamid for the outer layer 3. The inner layer 2 thus forms a longitudinal lumen 12 with a very low friction coefficient, lower than that of the material forming the outer layer 3, and a non kinking capacity, 5 while the outer layer 3 is easily weldable to the mate-rials commonly used for making balloons for angioplasty and the like.

Over the distal portion of the catheter tube 1 is posi-10 tioned a balloon 4 the distal end 5 of which is sealed to the outer layer 3 of the catheter tube 1, for instance by welding.

A tube 7 is arranged over the catheter tube 1, at a 15 radial distance thereof, thus defining an inflating lumen 8 for the balloon 4. The proximal end 6 of the balloon 4 is welded onto the distal end of said tube 7.

20 The tube 7 is exemplified here as being made of two tubes 9 and 10 longitudinally affixed to one another.
Preferably the tubes 9 and 10 shall be made of a polyamid to achieve easy fixing by welding procedures and to obtain a stepped stiffness. The proximal end of tube 25 10 is connected to conventional fittings (not shown) to feed the balloon and drive the catheter assembly.
Inside the catheter tube 1 is placed a guide wire 11 in sliding fit within the inner layer 2 forming the longitudinal lumen 12.
As a variant, the two tubes configuration of the tube 7 may be replaced by a single tube or by a configuration having more than two longitudinally affixed tubes.

Claims (3)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An interventional catheter comprising a catheter tube having two superposed layers of materials secured in relation to one another and with mechanical properties differing from one another, a longitudinal lumen in said catheter tube for the sliding fit of a guidewire, and a balloon with a proximal end and a distal end, said distal end sealingly surrounding said catheter tube, whereby the catheter tube has an inner layer forming the longitudinal lumen and an outer layer forming the outer surface of the catheter tube, wherein the inner layer is formed of a material with lower friction coefficient than the material forming the outer layer, the inner layer is a polyethylene, the outer layer is a polyamide, and the distal end of the balloon is welded to the outer polyamide layer of the catheter tube.
2. An interventional catheter according to claim 1, wherein the inner layer is a high density polyethylene.
3. An interventional catheter according to claim 1 or 2, wherein said two layers of the catheter tube are produced by extruding the outer layer over the inner layer.
CA002133698A 1993-10-27 1994-10-05 Interventional catheter Expired - Fee Related CA2133698C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP93117403A EP0650740B1 (en) 1993-10-27 1993-10-27 Interventional catheter
EP93117403.1 1993-10-27

Publications (2)

Publication Number Publication Date
CA2133698A1 CA2133698A1 (en) 1995-04-28
CA2133698C true CA2133698C (en) 1999-02-23

Family

ID=8213374

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002133698A Expired - Fee Related CA2133698C (en) 1993-10-27 1994-10-05 Interventional catheter

Country Status (9)

Country Link
US (2) US5843032A (en)
EP (1) EP0650740B1 (en)
JP (1) JP2918459B2 (en)
AT (1) ATE184799T1 (en)
AU (1) AU678293B2 (en)
CA (1) CA2133698C (en)
DE (1) DE69326551T2 (en)
DK (1) DK0650740T3 (en)
ES (1) ES2136107T3 (en)

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DE69326551D1 (en) 1999-10-28
AU7745794A (en) 1995-06-01
US6027477A (en) 2000-02-22
JP2918459B2 (en) 1999-07-12
EP0650740A1 (en) 1995-05-03
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EP0650740B1 (en) 1999-09-22
DK0650740T3 (en) 1999-12-20
US5843032A (en) 1998-12-01
CA2133698A1 (en) 1995-04-28
ES2136107T3 (en) 1999-11-16
JPH07178178A (en) 1995-07-18
ATE184799T1 (en) 1999-10-15

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