Bonding a polymer member to a metallic member

Details Bonding a polymer member to a metallic member Bonding a polymer member to a metallic member

1997-03-18

2001-05-29

Kennedy, Sharon (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S096010, C604S523000

Reexamination Certificate

active

06238376

ABSTRACT:

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 The catheter may then be withdrawn from the stenosis or advanced further into the patient's coronary anatomy to dilate additional stenoses.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 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 not 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. 581G 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 five 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.


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