Cordis Corporation

Other

Thomas N Trotta

Leonard Pinchuk

Robert S Shonk

Jeffrey A Johnson

Javier E Castaneda

Robert F Graham

Peter P Soltesz

A balloon dilatation catheter has a relatively strong proximal tube made of a material such as for example metal hypotubing. The distal end of the catheter includes an inflatable medical device or balloon, an inflation lumen and a guidewire lumen. A transition assembly or stiffening member is positioned between the proximal tube and the distal end section, providing for a flexible transition between the two components of diverse stiffness, namely the proximal tube and the flexible distal end portion. A proximal end of the stiffening member may float within a distal end of the proximal tube but the stiffening member distal end is affixed near its distal end to the shaft. The dilatation catheter may have a rapid exchange configuration, and is generally used in conjunction with a guiding catheter. During a procedure when the catheters are within the vascular system, the portion of the dilatation catheter near the transition readily follows curved portions of the inserted guiding catheter.

Balloon catheter with stiffening wire transition

A balloon dilatation catheter has a relatively stiff and strong proximal cannula made of a material such as for example metal hypotubing. The distal end of the catheter includes an inflatable medical device or balloon, an inflation lumen and a guidewire lumen. A transition assembly is positioned between the proximal cannula and the distal end section. This transition assembly has a stiffening member within a transition tube, and provides for a flexible transition between the two components of diverse stiffness, namely the proximal cannula and the flexible distal end portion. A proximal end of the stiffening member may float within a distal end of the proximal cannula, but the stiffening member distal end is affixed to the shaft. The dilatation catheter may have a rapid exchange configuration, and is generally used in conjunction with a guiding catheter. During a procedure when the catheters are within the vascular system, the transition section of the dilatation catheter readily follows curved portions of the inserted guiding catheter.

Balloon catheter with floating stiffener, and procedure

The medical devices of the present invention include polymer blends of polyamide and maleated polyethylene. The polyamide component of the blended materials of the present invention may include both homopolymers and copolymers. The other component of the present invention is preferably HDPE, with the addition of maleic anhydride. Accordingly, the materials of the present invention provide a unique combination of physical properties that are advantageous for use in various devices, including medical devices for maneuvering through the circulatory system. The properties of high-strength, capability of bonding to other polyamides, and kink resistance are retained. In addition, several physical properties and benefits are provided by the materials of the present invention, including low friction, functional groups to bond to low friction services, a range of flexibilities, and low gel counts.

Medical devices with reduced friction polyamides, and method

Dilatation balloons and catheters including same are provided. The balloons are fabricated of a material such as a nylon or a polyamide material, and they have an inflated, non-distended working profile as well as a stretched inflated profile which is achieved by applying pressure through a dilatation catheter or the like that is in excess of that needed to achieve the inflated, non-distended profile and which is adequate to effect dilatation or the like up to a maximum pre-bursting pressure application. The maximum pre-bursting size of the balloon can be tailored depending upon the needs of the particular balloon within a wide range of possible maximum pre-bursting sizes.

Balloons for medical devices and fabrication thereof

Dilation balloons and catheters including same are provided. The balloons are fabricated of a material such as a nylon or a polyamide material, and they have an inflated, non-distended working profile as well as a stretched inflated profile which is achieved by applying pressure through a dilatation catheter or the like that is in excess of that needed to achieve the inflated, non-distended profile and which is adequate to effect dilatation or the like up to a maximum pre-bursting pressure application. The maximum pre-bursting size of the balloon can be tailored depending upon the needs of the particular balloon within a wide range of possible maximum pre-bursting sizes.

In a torsion control catheter including a tubular body and a flexible tip connected to the tubular body, the improvement comprising a copolymer catheter tip composition comprising a first monomer of polyamide and a second monomer of polyamide having a lower alkyl side chain group attached to a polyamide backbone. The flexible catheter tip may include one or more tip members, at least one of which may be formed of the copolymer composition.

Soft tip catheter

Dilatation balloons and catheters including same are provided. The balloons are fabricated of a biaxially orientable material such as a nylon or a polyamide material, and they have an inflated, non-distended working profile as well as a stretched inflated profile which is achieved by applying pressure through a dilatation catheter or the like that is in excess of that needed to achieve the inflated, non-distended profile and which is adequate to effect dilatation or the like up to a maximum pre-bursting pressure application. The maximum pre-bursting size of the balloon can be tailored depending upon the needs of the particular balloon within a wide range of possible maximum pre-bursting sizes.

A catheter balloon is manufactured and prepared for use by heating a portion of a thermoplastic tube and pressurizing the lumen of the tube to cause the heated tube portion to stretch. Preferably, a central section of the tube portion is heated to a degree greater than the end sections of the tube portions, so that the central section of the tube portion expands to a thinner wall thickness than the end sections of the tube portion. Thus, when this newly formed, integral balloon is expanded within a patient, the central section thereof tends to expand outwardly first, ahead of the end sections. When such a balloon carries a tubular stent within the patient, the early expansion of the central section against a longitudinally centered stent causes a central portion of the stent to expand outwardly first, keeping the stent firmly centered on the balloon as it is expanded by the balloon.

Method of catheter balloon manufacture and use

A catheter balloon is prepared for inflation, and the balloon is inflated by the following process. At least a portion of an elastic, thermoplastic tube is radially stretched until the radially stretched tube portion exhibits a desired increase in molecular orientation. The stretching conditions, such as selective heating, preferably cause a central section of the stretched tube portion to have less wall thickness than end sections of the tube portion. At least part of the tube portion may be longitudinally stretched relative to the tube, to create a desired biaxial molecular orientation. Thereafter, the tube portion is optionally placed into a stent, the tube portion being part of a catheter. The tube portion is inserted into a patient to position the stent and tube portion at a desired position, such as a location in the coronary artery. After positioning of the tube portion and stent, the lumen of the tube portion is pressurized to cause radial expansion of the tube portion within the patient, with a central section of the tube portion expanding first.

A balloon catheter comprises a flexible, elongated member, an inflatable balloon carried on the elongated member to define an inflated chamber within the balloon, and an inflation conduit extending along the member and communicating with the inflation chamber. The inflatable balloon, in turn, defines a wall which comprises at least three bonded layers. A first pair of the layers comprises a flexible plastic material which is typically a condensation polymer. A second of the layers comprises a flexible polymer which is typically a vinylic polymer which is covalently bonded to the first layers and positioned between them.

Puncture resistant balloon catheter

A balloon catheter having an inflatable balloon in which the outer surface of the inflatable balloon is surrounded by an elastomeric sleeve. The sleeve is attached throughout at least a majority of its area to the balloon outer surface to provide pin hole and abrasion resistance. Preferably, the inflatable balloon is made of a flexible material of less elasticity than the material of the elastomeric sleeve. Thus the balloon expands to a generally limited maximum transverse dimension, while the collapse of the balloon is facilitated by the elastomeric sleeve.

Medical device tubing is prepared from a blended polymer which is a blend of polyetheramide having substantially no ester linkages together with either or both of a polyamide and a polyesteretheramide having a hardness of at least about Shore 70D. The resulting tubing has an exceptionally high ratio of burst strength to flexibility, and the blended polymer retards blooming of the tubing that is believed to result from migration of monomers to the surface of the tubing.

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Sunny Isles Beach, FL, United States of America

Thomas N Trotta