CA2283167A1 - Bonding a polymer member to a metallic member - Google Patents

Bonding a polymer member to a metallic member Download PDF

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Publication number
CA2283167A1
CA2283167A1 CA002283167A CA2283167A CA2283167A1 CA 2283167 A1 CA2283167 A1 CA 2283167A1 CA 002283167 A CA002283167 A CA 002283167A CA 2283167 A CA2283167 A CA 2283167A CA 2283167 A1 CA2283167 A1 CA 2283167A1
Authority
CA
Canada
Prior art keywords
tubular member
proximal
polymeric
inner lumen
distal ends
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.)
Abandoned
Application number
CA002283167A
Other languages
French (fr)
Inventor
Eric D. Peterson
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.)
Abbott Cardiovascular Systems Inc
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2283167A1 publication Critical patent/CA2283167A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/66Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by liberation of internal stresses, e.g. shrinking of one of the parts to be joined
    • B29C65/68Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by liberation of internal stresses, e.g. shrinking of one of the parts to be joined using auxiliary shrinkable elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • A61M25/0014Connecting a tube to a hub
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/56Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
    • B29C65/64Joining a non-plastics element to a plastics element, e.g. by force
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112Single lapped joints
    • B29C66/1122Single lap to lap joints, i.e. overlap joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/52Joining tubular articles, bars or profiled elements
    • B29C66/522Joining tubular articles
    • B29C66/5221Joining tubular articles for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/74Joining plastics material to non-plastics material
    • B29C66/742Joining plastics material to non-plastics material to metals or their alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/731General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the intensive physical properties of the material of the parts to be joined
    • B29C66/7311Thermal properties
    • B29C66/73117Tg, i.e. glass transition temperature
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/74Joining plastics material to non-plastics material
    • B29C66/742Joining plastics material to non-plastics material to metals or their alloys
    • B29C66/7428Transition metals or their alloys
    • B29C66/74283Iron or alloys of iron, e.g. steel
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7542Catheters

Abstract

This invention is directed to a method of bonding thermoplastic catheter parts to a metallic member such as hypotubing and the product formed. The polymeric material is hot pressed against the metallic member with sufficient pressure to ensure plastic deformation of the polymeric material. A fluid tight bond is formed which can withstand pressures of up to 650 psi.

Description

BONDING A POLYMER MEMBER TO A METALLIC MEMBER
BACKGROUND OF THE INVENTION
This invention generally relates to attachment of high strength polymeric members to a metallic member and particularly to the attachment of polymeric tubes to metallic tubes in intravascular devices such as catheters for use in percutaneous transluminal coronary angioplasty (PCTA).
In a typical PTCA procedure a dilatation balloon catheter is advanced over a guidewire to a desired location within the patient's coronary anatomy where the balloon of the dilatation catheter is properly positioned within the stenosis to be dilated. The balloon is then inflated to a predetermined size with radiopaque liquid at relatively high pressures (generally 4-20 atmospheres) to dilate the stenosed region of the diseased artery. One or more inflations may be needed to effectively dilate the stenosis. The catheter may then be withdrawn from the stenosis or advanced further into the patient's coronary anatomy to dilate additional stenoses.
The inflation pressures used in PTCA procedures have increased considerably due to the utilization of high strength balloon materials. However, such higher pressures also place substantial stress on other catheter components and particularly the junctions between various catheter components. Examples of such components and junctions are the adapter and the junction with the proximal end of a metallic hypotube and the adapter and the distal end of a metallic hypotube and the polymeric tubular products which form the distal portion of a rapid exchange type dilatation catheter. Present manufacturing procedures involve the use of adhesives, heat shrinking and the like which limit the materials which can be used and the combination of materials which can be used and which complicate the manufacturing procedure. What has been needed and has heretofore been heretofore been unavailable is an uncomplicated procedure which produces high strength, hermetically sealed bonds.
SUMMARY OF THE INVENTION
The present invention is directed to a system for securely bonding a high strength polymer material to a metallic member and particularly a small diameter tubular polymeric product to a small diameter tubular metallic product.
In accordance with the invention the polymeric member is disposed in contact with the metallic member, the polymer member is hot pressed against the metallic member at a temperature above the glass transition temperature of the polymeric material but less than the melting point thereof to effect significant plastic deformation of the polymeric material. The result is a high strength bond and a fluid tight seal which will no leak even under high pressures.
One presently preferred embodiment of the invention is directed to the bonding of small diameter tubular polymeric members to small diameter tubular metallic members. A portion of the metallic member is inserted into the inner lumen of a polymeric tubular member and a heat shrinkable collar is disposed about the portion of the polymeric tubular member into which the metallic member is disposed.
Heat is applied to the heat shrinkable collar, and the polymeric tubular member, causing the collar to shrink and apply sufficient pressure against the polymeric tubular member to plastically deform it and thereby bond the polymeric material to the surface of the metallic member. The heat shrinkable collar may be left in place or removed from the polymeric tubular member after the bond is formed. A
masking layer may be provided between the collar and the polymeric tubular member to prevent bonding and facilitate removal of the collar.
Generally, the polymeric material should be a high strength thermoplastic polymer which is at most semi-crystalline, preferably non-crystalline, and which is not ethylenically cross-linked. The preferred polymeric material is an engineering polymer such as polyetheretherketone (PEEK), e.g. 581 G sold by Victrex. Other polymeric materials include polyetheramide sold under the trademark ULTEM by General Electric, polyphenylene sulfide and polysulfone. The metallic member may be stainless steel, such as 304 stainless steel, or a superelastic or pseudoelastic NiTi alloy. Other metallic materials may be used such as titanium and alloys thereof.
There is no special surface preparation needed for the metallic members other than removing surface contaminants such as oil, grease and the like.
One of the advantages of the invention is that the bond is strong enough and the seal is sound enough so the number of parts needed to construct an intravascular catheter is reduced considerably. For example, in present conventional manufacturing practices for rapid exchange type catheters, such as the LIFESTREAM Dilatation Catheter sold by Advanced Cardiovascular Systems, Inc., up to fve parts are needed to attach a proximal hub or adapter to the proximal end of a hypotube shaft. With the present invention the distal end of the adapter can be bonded directly to the proximal extremity of a hypotube.
tn addition to a signi5cant reduction in the number of parts, there is no adhesive used, so there is [sick no requirements for an adhesive curing step to form an adhesive bond. The bond of the present invention between the polymeric material and metallic material is strong, durable and provides a fluid tight seal between the joined parts. These and other advantages of the invention will become more apparent from the following detailed description and the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is an elevational view, partially in section, of a rapid exchange type dilatation catheter embodying features of the invention.
Fig. 2 is a transverse cross-sectional view of the catheter shown in Fig. 1 taken along the lines 2-2.
Fig. 3 is a transverse cross-sectional view of the catheter shown in Fig. 1 taken along the lines 3-3 Fig. 4 is a transverse cross-sectional view of the catheter shown in Fig. 1 taken along the lines 4-4.
Fig. 5 is an enlarged partial elevational view of a polymeric tubular member in position to be hot pressed against the metallic tubular member to facilitate the bonding therebetween.
Fig. 6 is a longitudinal cross-sectional view of the members shown in Fig. 5 after the boding procedure.
DETAILED DESCRIPTION OF THE INVENTION
Figs. 1-5 illustrate a rapid exchange type balloon dilatation catheter 10 which has an elongated shaft 11 with a dilatation balloon 12 on a distal shaft section 13 of the shaft and an adapter 14 on the proximal end of the proximal shaft section 15.
The proximal shaft 15 is formed of a metallic hypotube 16 with a lubricious coating 17. The distal shaft section 13 includes a distally extending tubular member which has a guidewire receiving inner lumen 20 and which extends through the interior of the balloon 12 to the port 21 in the distal end of the catheter. A
guidewire 22 is shown disposed within the lumen 20 and extending out the distal port 21 and the proximal port 23. The inflation lumen 24 is in fluid communication with the interior of dilatation balloon 12 through inflation port 25 The distal extremity 26 f the adapter 14 is hot pressed bonded to the proximal extremity of the proximal shaft section 15 in accordance with the invention. A
high strength polymeric tubular extension 27 is hot press bonded to the distal extremity of the proximal shaft section 15 in the same manner as the distal extremity of the adapter is bonded to the proximal extremity of the proximal shaft section. In both cases the coating 17 is removed from the exterior of the hypotube 16 to facilitate direct bonding to the metallic surface.
Figs. 5 and 6 illustrate a presently preferred method of bonding the polymeric member, tubular extension 27 to the metallic tubular member 16. As shown in Fig.
5, the distal end of the metallic tubular member 16 is inserted into the inner lumen 28 of the tubular extension 27. A heat shrinkable tubular collar 29 is disposed about the proximal extremity of the tubular extension 27 and heated to heat shrink temperatures to press the proximal extremity against the exposed surface of the tubular member 16. With the high temperatures and the pressures applied, the proximal extremity is plastically deformed and is securely bonded to the metallic surface. The distal extremity of the adapter 14 is bonded to the proximal extremity of the proximal shaft section in essentially the same manner.
EXAMPLE
A stainless steel hypotube with an outer diameter of 0.024 inch (0.6 mm) and inner diameter of 0.016 inch (0.4 mm) was inserted into the inner lumen of a ~.

polymeric tubular member form of polyetheretherketone (PEEK). The inner lumen of the polymeric tubular member was about 0.026 inch (0.7 mm) and the outer diameter was about 0.035 inch (0.9 mm). A short piece of a heat shrinkable tubular FEP with an outer diameter of about 0.077 inch (2 mm)and an inner diameter of 5 about 0.055 inch (1.4 mm) was disposed about the exterior of the polymeric tubular member. The assembly was subjected to an air stream at 450°
F.(232° C.) until the tubing becomes cloudy. Upon cooling, the FEP tubular collar was removed. The bond between the PEEK member and the stainless steel member was sound and leak free at internal pressures of up to fi50 psi.
Although individual features of embodiments of the invention may be shown in some of the drawings and not in others, those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of one or more of the other embodiments.

Claims (9)

WHAT IS CLAIMED IS:
1. An intravascular catheter with an elongated shaft comprising:
a) an elongated metallic tubular member having proximal and distal ends and an inner lumen extending between the proximal and distal ends;
b) a polymeric tubular member having proximal and distal ends and an inner lumen extending between the proximal and distal ends; in contact with and bonded to a surface of the metallic tubular member by a hot pressed bond between one part of the metallic tubular member and one part of the polymeric tubular member, the polymeric tubular member having a deformed section at the hot pressed bond and a nondeformed section longitudinally adjacent thereto.
2. The intravascular catheter of Claim 1 wherein the polymeric material is a thermoplastic polymer selected from the group consisting of polyetheretherketone, polyetheramide, polyethylene sulfide and polysulfone.
3. The intravascular catheter of Claim 1 wherein one end of the polymeric tubular member is disposed about and hot press bonded to the exterior of one end of the metallic tubular member.
4. A balloon dilatation catheter comprising:
a) an elongated proximal shaft section formed at least in part of a metallic tubular member having proximal and distal ends and an inner lumen extending between the proximal and distal ends;

b) an elongated distal shaft section formed at least in part of a polymeric tubular member having proximal and distal ends and an inner lumen extending between the proximal and distal ends, in contact with and bonded to a surface of the metallic tubular member by a hot pressed bond between part of the metallic tubular member and part of the polymeric tubular member, the polymeric tubular member having a deformed section at the hot pressed bond; and c) an inflatable dilatation balloon on the distal shaft section having an interior in fluid communication with the inner lumen of the polymeric tubular member.
5. An intravascular catheter with an elongated shaft comprising:
a) an elongated metallic tubular member having proximal and distal ends and an inner lumen extending between the proximal and distal ends;
b) a polymeric adapter having proximal and distal ends and an inner lumen extending between the proximal and distal ends, in contact with and bonded to a surface of the metallic tubular member by a hot pressed bond between the proximal end of the metallic tubular member and the distal end of the polymeric adapter, the polymeric tubular member having a deformed section at the hot pressed bond and a nondeformed section longitudinally adjacent thereto.
6. The intravascular catheter of Claim 5 wherein the distal end of the polymeric adapter is bonded to the exterior of the proximal end of the metallic tubular member.
7. The intravascular catheter Claim 6 wherein the inner lumen of the metallic tubular member is in fluid communication with the inner lumen of the adapter.
8. A rapid exchange type balloon dilatation catheter comprising:
a) an elongated proximal shaft section formed at least in part of a metallic tubular member having proximal and distal ends and a first inner lumen extending therein;
b) an elongated distal section, which is formed at least in part of a polymeric tubular member, having proximal and distal ends, a first port in the distal end and a second port spaced proximal to the distal end, a dilatation balloon on the distal shaft section and with an interior, a second inner lumen extending therein which is in fluid communication with the first inner lumen in the metallic tubular member and the interior of the dilatation balloon and a third inner lumen which is in fluid communication with the first and second ports, the polymeric tubular member being in contact with and bonded to a surface of the metallic tubular member by a hot pressed bond between part of the metallic tubular member and part of the polymeric tubular member, the polymeric tubular member having a deformed section at the hot pressed bond.
9. The catheter of Claim 1 wherein the deformed section of the polymeric tubular member has a smaller outer diameter than the nondeformed section.
CA002283167A 1997-03-18 1998-03-16 Bonding a polymer member to a metallic member Abandoned CA2283167A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/819,965 US6238376B1 (en) 1997-03-18 1997-03-18 Bonding a polymer member to a metallic member
US08/819,965 1997-03-18
PCT/US1998/005067 WO1998041384A1 (en) 1997-03-18 1998-03-16 Bonding a polymer member to a metallic member

Publications (1)

Publication Number Publication Date
CA2283167A1 true CA2283167A1 (en) 1998-09-24

Family

ID=25229546

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002283167A Abandoned CA2283167A1 (en) 1997-03-18 1998-03-16 Bonding a polymer member to a metallic member

Country Status (5)

Country Link
US (2) US6238376B1 (en)
EP (1) EP1009620A1 (en)
JP (1) JP2001516296A (en)
CA (1) CA2283167A1 (en)
WO (1) WO1998041384A1 (en)

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Also Published As

Publication number Publication date
US6238376B1 (en) 2001-05-29
JP2001516296A (en) 2001-09-25
US20010011177A1 (en) 2001-08-02
EP1009620A1 (en) 2000-06-21
WO1998041384A1 (en) 1998-09-24

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