Cordis Corporation

Ethicon, Gmbh

Atrion Medical Products, Inc.

Nicholas A Green

Peter P Soltesz

Jeffrey G Gold

Susana M Gore

Mark Mueller

David R Fischell

Robert E Fischell

Fred E Williams, Jr

Mark L Pomeranz

Robert W Reinhardt

There are two methods for securing the ultra-thin distal sheath section over the distal tip. A preferred method is to employ another thin tube shrunk down over the distal end of the ultra-thin distal sheath. It is also envisioned that simply shrinking the ultra-thin distal sheath section down on the tapered section of the distal tip will hold it securely. A monorail (rapid exchange) version of this stent delivery system is also envisioned. A second version of the present invention includes an unsheathed primary stenting system which uses radiopaque elastic bands mounted over the ends of the balloon just proximal and just distal to the stent to provide the lowest possible profile for a primary stent delivery system without the risk of stent embolization.

Stent delivery catheter system for primary stenting

A removable vascular filter system for blocking micro- and macro-emboli while allowing the continued perfusion of blood comprises a filter membrane positioned on a guidewire, wherein a free end of the membrane sits tightly against the guidewire when the filter membrane is in a collapsed state and wherein the filter has a device for deploying the filter membrane to assume a position substantially normal to the longitudinal axis of the guidewire. The filter membrane is comprised of a fine mesh material which has a pore size capable of blocking emboli while allowing continued blood flow, a preferred embodiment of which comprises regularly spaced, laser-formed holes, and in which the membrane has a scalloped proximal profile. A capture mechanism is similarly described.

Vascular filter system with guidewire and capture mechanism

An ultra-thin distal sheath section of the sheathed system uses heat shrinkable elastomer tubing with a wall thickness that is less than 0.05 mm and may be less than 0.025 mm. There are two methods for securing the ultra-thin distal sheath section over the distal tip. A first method is to employ another thin tube shrunk down over the distal end of the ultra-thin distal sheath. It is also envisioned that simply shrinking the ultra-thin distal sheath section down on the tapered section of the distal tip will hold it securely. A monorail (rapid exchange) version of this stent delivery system is also envisioned. A second version uses radioopaque elastic bands mounted over the ends of the balloon just proximal and just distal to the stent to provide a low profile for a primary stent delivery system. These radioopaque elastic bands could contain a high-density material such as tungsten to make them radioopaque and eliminate the need for radioopaque markers normally attached to the angioplasty balloon inner shaft.

In accordance with the present invention, a fluid compression instrument and method for particular use in pre-surgically securing and conforming a vascular stent upon an angioplasty balloon, includes a housing for containing pressurized fluid and an elastic enclosing diaphragm secured within the housing and having an internal cavity and opening arranged to receive the stent disposed on the balloon catheter for secured compression. A pressure chamber is arranged within the housing as an envelope about the diaphragm to enable pressurized fluid forces within the pressure chamber to be imposed upon the outer surface of the diaphragm and transmitted through the diaphragm enabling circumferential application against the inserted stent in order uniformly to compress the stent with correspondingly secured purchase against the deflated balloon surface, producing complete adhesion of the stent thereon. The subsequent balloon inflation angioplasty and stent expansion is not impaired since the balloon remains in its deflated shape with the compressed stent closely conforming in contour throughout the balloon's 360.degree. periphery. The entire stent mesh is uniformly compressed down including the open stent ends which prevents the many tiny stent mesh edges from protruding out and effectively prevents both vascular abrasion as well as shifting of the stent on the deflated balloon during the angioplasty insertion procedure.

Process for stent compression

A balloon element for use in a catheter has a multi-layered single-walled structure and a compliance characteristic exhibiting a first, non-compliant region at low operating pressures and a secondary compliant region at higher operating pressures. The properties of the balloon element permit it to serve for both dilatation of bodily vessels and stent delivery and implantation. A method of manufacturing the balloon element involves extrusion of a tube of material, such as PEEK, which serves as an inner wall layer of the finished balloon element and provides the desired strength and compliance characteristics of the balloon element, and a post-extrusion over the first tube, which provides an outer wall layer in the finished balloon element imparting abrasion resistance and other desirable mechanical properties.

Single-walled balloon catheter with non-linear compliance characteristic

A stent delivery system including a stent delivery catheter, a stent dilatation balloon sealingly affixed to the catheter and adapted for inflation by a pressurized fluid introduced into the catheter, and an expandable stent surrounding the balloon and adapted for implantation into a bodily vessel upon inflation of the balloon. The system also includes structure integral with the balloon and possibly the catheter for resisting movement of the stent relative to the balloon throughout all phases of a stent delivery and implantation operation prior to deflation and withdrawal of the balloon from the stent following implantation of the stent.

Catheter assembly

Stent compression instrument

An intravascular catheter carries a helical reinforcement member embedded within at least a portion of the tubular wall of the catheter. The helical reinforcement member comprises a helical first portion having coils of greater pitch than the pitch of helical coils of a second portion. Preferably, the catheter is for insertion into brain arteries, and comprises a flexible tube having an outer diameter of no more that about 0.05 inch, for example 3 French or smaller. The flexible tube defines outer and inner tubular layers. The inner tubular layer surrounds a catheter lumen and comprises chemically inert fluorinated polymer such as PTFE. The outer tubular layer comprises at least three longitudinally spaced, connected tubular sections. The sections are of successively increasing flexibility from the proximal toward the distal catheter end. Also, manufacturing methods are disclosed pertaining to increasing the flexibility of a section of the catheter and joining together in abutting relation a pair of dissimilar catheter reinforcement members.

Intravascular catheter

Intravascular catheter and method of manufacturing

An intravascular catheter carries a helical reinforcement member embedded within at least a portion of the tubular wall of the catheter. The helical reinforcement member comprises a helical first portion having coils of greater pitch than the pitch of helical coils of a second portion. Preferably, the catheter is for insertion into brain arteries, and comprises a flexible tube having an outer diameter of no more that about 0.05 inch, for example 3 French or smaller. The flexible tube defines outer and inner tubular layers. The inner tubular layer surrounds a catheter lumen and comprises a chemically inert fluorinated polymer such as PTFE. The outer tubular layer comprises at least three longitudinally spaced, connected tubular sections. The sections are of successively increasing flexibility from the proximal toward the distal catheter end. Also, manufacturing methods are disclosed pertaining to increasing the flexibility of a section of the catheter and joining together in abutting relation a pair of dissimilar catheter reinforcement members.

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Kinnelon, NJ, United States of America

Nicholas A Green