U.S. patent application number 09/774470 was filed with the patent office on 2001-08-02 for bonding a polymer member to a metallic member.
This patent application is currently assigned to Advanced Cardiovascular Systems, Inc.. Invention is credited to Peterson, Eric D..
Application Number | 20010011177 09/774470 |
Document ID | / |
Family ID | 25229546 |
Filed Date | 2001-08-02 |
United States Patent
Application |
20010011177 |
Kind Code |
A1 |
Peterson, Eric D. |
August 2, 2001 |
Bonding a polymer member to a metallic member
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.
Inventors: |
Peterson, Eric D.; (Fremont,
CA) |
Correspondence
Address: |
Edward J. Lynch
Heller Ehrman White & McAuliffe
275 Middlefield Road
Menlo Park
CA
94025-3506
US
|
Assignee: |
Advanced Cardiovascular Systems,
Inc.
|
Family ID: |
25229546 |
Appl. No.: |
09/774470 |
Filed: |
January 30, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09774470 |
Jan 30, 2001 |
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08819965 |
Mar 18, 1997 |
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6238376 |
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Current U.S.
Class: |
606/192 |
Current CPC
Class: |
B29C 65/68 20130101;
B29C 66/73117 20130101; B29C 66/742 20130101; B29C 66/71 20130101;
A61M 25/0014 20130101; A61M 25/104 20130101; B29C 66/1122 20130101;
B29C 66/71 20130101; B29C 66/5221 20130101; B29C 65/64 20130101;
B29C 66/71 20130101; B29C 66/71 20130101; B29C 66/71 20130101; B29L
2031/7542 20130101; B29C 66/74283 20130101; B29K 2077/00 20130101;
B29K 2071/00 20130101; B29K 2081/04 20130101; B29K 2081/06
20130101 |
Class at
Publication: |
606/192 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A method of securing a polymeric member to a metallic member in
a high strength fluid tight relationship comprising: a) mounting
the polymeric member against the metallic member; and b) hot
pressing the polymeric member against the metallic member at a
temperature above the glass transition temperature and below the
melting point of the polymeric material of the polymeric member
while subjecting the polymeric material to plastic deformation.
2. The method of claim 1 wherein the polymeric member is a tubular
element with an inner lumen extending therethrough and at least
part of the metallic member is disposed within the inner lumen of
the polymeric member and the polymeric material surrounding the
metallic member is hot pressed against the portion of the metallic
member within the inner lumen.
3. The method of claim 1 wherein the polymeric material from which
the polymeric member is formed is a thermoplastic polymer selected
from the group consisting of polyetheretherketone, polyetheramide,
polyphenylene sulfide and polysulfone.
4. The method of claim 1 wherein the hot pressing of the polymeric
member against the metallic member includes placing a heat
shrinkable member about the polymeric member and the metallic
member, heating the heat shrinkable member to shrink said member
against the polymeric and metallic members, causing the
temperatures of both the polymeric and metallic members to increase
to a temperature above the glass transition temperature of the
polymeric material and apply adequate pressure to cause the
polymeric member to be plastically deform and bond to the metallic
member.
5. The method of claim 4 wherein the heat shrinkable member is
removed from the junction between the polymeric material and the
metallic member.
6. The method of claim 4 wherein the heat shrinkable member is a
polymeric collar.
7. The method of claim 4 wherein the polymeric collar is formed of
a fluoropolymer.
8. 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;
and c) a hot pressed bond between one part of the metallic tubular
member and one part of the polymeric tubular member.
9. The intravascular catheter of claim 8 wherein the polymeric
material is a thermoplastic polymer selected from the group
consisting of polyetheretherketone, polyetheramide, polyphenylene
sulfide and polysulfone.
10. The intravascular catheter of claim 8 wherein the 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.
11. 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; c) a hot pressed bond between
part of the metallic tubular member and part of the polymeric
tubular member; and d) an inflatable dilatation balloon on the
distal shaft section having an interior in fluid communication with
the inner lumen of the polymeric tubular member.
12. 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; and c)
a hot pressed bond between the proximal end of the metallic tubular
member and the distal end of the polymeric adapter.
13. The intravascular catheter of claim 12 wherein the distal end
of the polymeric adapter is bonded to the exterior of the proximal
end of the metallic tubular member.
14. The intravascular catheter of claim 13 wherein the inner lumen
of the metallic tubular member is in fluid communication with the
inner lumen of the adapter.
15. 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 shaft
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 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; and c) a hot pressed bond between
part of the metallic tubular member and part of the polymeric
tubular member.
Description
BACKGROUND OF THE INVENTION
[0001] 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).
[0002] 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.
[0003] 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
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] In addition to a significant reduction in the number of
parts, there is no adhesive used, so there is 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
[0010] FIG. 1 is an elevational view, partially in section, of a
rapid exchange type dilatation catheter embodying features of the
invention.
[0011] FIG. 2 is a transverse cross-sectional view of the catheter
shown in FIG. 1 taken along the lines 2-2.
[0012] FIG. 3 is a transverse cross-sectional view of the catheter
shown in FIG. 1 taken along the lines 3-3
[0013] FIG. 4 is a transverse cross-sectional view of the catheter
shown in FIG. 1 taken along the lines 4-4.
[0014] 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.
[0015] FIG. 6 is a longitudinal cross-sectional view of the members
shown in FIG. 5 after the boding procedure.
DETAILED DESCRIPTION OF THE INVENTION
[0016] 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 18 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.
[0017] 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.
[0018] 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
[0019] 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 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.degree. F.(232.degree. 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 650
psi.
[0020] 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.
* * * * *