Adhesive bonding and miscellaneous chemical manufacture – Methods – Surface bonding and/or assembly therefor
Reexamination Certificate
1999-03-19
2001-07-10
Aftergut, Jeff H. (Department: 1733)
Adhesive bonding and miscellaneous chemical manufacture
Methods
Surface bonding and/or assembly therefor
C156S180000, C156S296000, C156S305000, C156S308400, C156S308600, C156S272200, C156S275100, C604S524000, C604S527000, C604S526000
Reexamination Certificate
active
06258195
ABSTRACT:
FIELD OF THE INVENTION
The present invention is related generally to medical device tubular members and methods for manufacturing the tubular members. More specifically, the present invention relates to methods for making catheter tubular members including aligning multiple strands of material and fusing adjacent strands together to form a tube.
BACKGROUND OF THE INVENTION
The use of tubing and tubular members is ubiquitous in medical devices. In many tube-containing devices, such as intravascular catheters, the physical characteristics of the tubing are of great importance. For example, in catheters used in percutaneous transluminal coronary angioplasty (PTCA), the catheter tubing must extend from the patient's groin, through the femoral artery, over the aortic arch, into a coronary ostium, thereafter through tortuous vessel passages and into a secondary or tertiary coronary vessel within the heart. The tubing must be sufficiently flexible to track the often-tight turns through the vessels, yet capable of being pushed through the coronary vessels from a location near the groin. The tubing must also be capable of transmitting rotational forces applied near the groin into tip rotation near the heart.
The above requirements for catheters are often referred to as trackability, pushability, and torqueability. Meeting these requirements is complicated by a further requirement of having a small profile or outside diameter, so as to be able to pass through a small lumen, such as a remote coronary vessel of small inside diameter. Catheter tubing has often been made using variations of common tubing manufacture processes such as extrusion. Polymer is sometimes extruded over a mandrel, wrapped with wire or braid, and extruded over in a second pass, covering the braid. Such a process can impart a lubricious and/or strong inner surface, a strong intermediate braid, and a lubricious outer surface. The use of extrusion to form medical tubing commonly results in a homogenous tube wall consisting of melted polymer which is substantially uniform in orientation and composition.
What would be desirable is a simple method for making medical tubing that results in a tube having improved axial strength and pushability. It is further desired to have a method of manufacture in which the polymeric tube wall can incorporate varying or selected circumferential portions over the tube length with non-homogenous materials and properties. What would be further desirable is a method for making medical tubing having shapes and wall structures not possible using conventional extrusion methods.
SUMMARY OF THE INVENTION
The present invention provides improved medical tubular members or tubes formed of multiple strands bonded together. One use of such tubes is in construction of angioplasty catheters. One method utilizes multiple spools containing strand material disposed about a central mandrel, with the strands aligned with and disposed evenly about the mandrel. Both the mandrel and aligned strands then enter a die or other bonding device. Adjacent strands are bonded together to form a tube, with the tube preferably having at least one lumen therethrough. The strands making up portions of the tube wall can vary in composition from other strands making up other portions of the tube wall. The bonded strand tube walls can provide tubes having improved handling characteristics relative to tube walls formed from extruded polymer.
One method according to the present invention uses heat to fuse adjacent strands together by melting only the exterior surface or top layer of the strands. The resulting tube walls can retain much of the fine structure of the original strands. Another method uses heat to fuse adjacent strands together by melting a substantial portion of the strand well into the strand interior. The resulting tube walls can have a smoother surface, can be molded to have less of the structure of the original strands, and can have more shape dictated by polymer flow and the shape of the forming mandrel and die. Another method utilizes adhesive to bond the strands together. Yet another method utilizes solvent welding to fuse adjacent strands. Still another method includes UV curable material within the strands and exposure to UV light to bond the strands together.
Strands used to form the tube are preferably formed of polymeric materials suitable for bonding to adjacent strands. One class of strands includes metallic wire coated with polymeric material. Another class of strands includes fibrous material coated with polymeric material. Yet other strands are formed of multiple filaments. In another embodiment, the strands may be coated as they pass into or within the bonding device, rather than being pre-coated.
After bonding adjacent strands into a tube, some embodiments include further processing. One method includes extrusion of polymer over the multi-strand tube. Another method includes applying a metallic coating over the tube by a method such as sputter coating. Yet another method includes winding a strand about the tube which can increase the collapse strength of the tube.
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Ebeling Philip J.
Holman Thomas J.
Olson Gregory K.
Aftergut Jeff H.
Crompton Seager & Tufte LLC
Sci-Med Life Systems, Inc.
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