Baxter International Inc.

Intramed Laboratories, Inc.

Other

Edwards Lifesciences Corporation

Stephen A Sosnowski

David S Rosenthal

John H Parrish

Jan Wicherski

Thomas J Fogarty

Thomas A Howell

Steven W Kovalcheck

Nadhir B Kosa

Alan J Schempp

Jan R Wicherski

Methods for utilizing a device for blocking (e.g., embolizing) the side branches of an anatomical passageway under endoscopic guidance. The device comprises an elongate catheter body having a side branch blocking apparatus, such as an embolization catheter, disposed therein and further incorporating an endoscope (e.g., an angioscope). The incorporated endoscope is useable to a) visually locate side branches which emanate from the anatomical passageway and b) visually observe the operation of the side branch blocking apparatus. Disclosed are methods for performing in situ embolization of the side branches of a vein, under angioscopic visualization. The endoscopic component of the device may also be utilized to visually observe the use and/or effect of one or more separate device, such as valvulotome(s) used for cutting venous valves located within the lumen of a vein.

Method of endoscopically visualized occlusion of the side branches of an anatomical passageway

Generally described, the present invention comprises a medical device for implantation in biological tissue and a method of making the medical device. The medical device comprises an organic compound forming at least a portion of the medical device and a beta radiation emitting element chemically bonded to the organic compound of the medical device. The beta emitter preferably causes the medical device to generate a beta radiation greater than 0.0002 .mu.Ci/cm. The beta radiation emitting element can be tritium preferably incorporated into the organic compound of the medical device by a Wilzbach process. The Wilzbach process involves an entropic exchange of the beta emitting element for elemental hydrogen in a vacuum sealed reaction chamber. On the other hand, the beta radiation emitting element may comprise Carbon 12, or other similar beta emitter, which is incorporated directly into the backbone of the organic compound prior to manufacturing the medical device from the organic compound. In another aspect of the present invention, rather than placing the medical device itself in a reaction chamber for incorporation of a beta emitting element, a mass of organic material may be placed in a reaction chamber. Again, a beta emitting element is preferably incorporated into the organic material via the Wilzbach process.

Radioactive medical devices for inhibiting a hyperplastic response of

The device for blocking (e.g., embolizing) the side branches of an anatomical passageway under endoscopic guidance. The device comprises an elongate catheter body having a side branch blocking apparatus, such as an embolization catheter, disposed therein and further incorporating an endoscope (e.g., an angioscope). The incorporated endoscope is useable to A) visually locate side branches which emanate from the anatomical passageway and b) visually observe the operation of the side branch blocking apparatus. Also disclosed are methods for utilizing a device of the forgoing character, including methods for performing in situ embolization of the side branches of a vein, under angioscopic visualization. The endoscopic component of the device may also be utilized to visually observe the use and/or effect of one or more separate device, such as valvulotome(s) used for cutting venous valves located within the lumen of a vein.

Endoscopically-assisted device for endoluminal occlusion of anatomical

A radioactive suture for inhibiting an intimal hyperplastic response comprises a needle and a suture material having a radioactive beta-emitting element. This radioactive element is preferably chemically bonded to an organic substrate of the suture material. It is preferred that the radioactive suture material generates a beta radiation greater than 0.0002 uCi/cm. A first preferred method for producing the radioactive suture comprises the steps of placing the suture needle and the suture material in a sealed reaction chamber. Once the suture is in the reaction chamber, an ionized beta radiation emitting element, preferably ionized tritium, is introduced into the chamber. While in the chamber, an entropic exchange process begins wherein the beta radiation emitting element is exchanged for hydrogen molecules in the organic suture material. Once the desired level of tritium or other beta radiation emitting element is incorporated in the suture material, the reaction chamber is flushed. The suture is then rinsed, dried, removed from the reaction chamber, and packaged. In another aspect, a radioactive suture may be fabricated from an organic polypropylene material. A beta radiation emitting element, preferably tritium, is incorporated directly into a backbone of the organic polypropylene material. The now radioactive polypropylene material is extruded into a suture thread, which is attached to a suture needle and packaged for shipment and later use. Although not required by the present inventive method, the preferred embodiment of the organic polypropylene material comprises carbon 12.

Radioactive medical suture and method of making the same

A method and device for cutting venous valve located within the lumen of a vein. The device comprises an elongate shaft of rigid or flexible construction and a valvulotome blade positioned on the distal end of said elongate shaft. The valvulotome blade comprises an elongate shank portion which is disposed substantially parallel to the longitudinal axis of the shaft, and a head portion which extends laterally from the shank portion of the blade. The head portion of the blade comprises an outer venous wall abutment surface and a proximal cutting surface. The venous wall abutting surface is a spaced distance from the proximal cutting surface such that the venous wall abutment surface may be forced into abutment with the venous wall and the device may be drawn through a venous valve such that the proximal cutting surface will cut the venous valve, but will not come into contact with the adjacent vein wall. The device may incorporate a mechanism, such as a protruding loop of wire, which will abut against the blood vessel wall so as to force the venous wall abutment surface of the valvulotome blade against the opposite wall of the vein or during the venous valve cutting procedure. The method of the invention provides for operation of the device to effect cutting of venous valve, and may be performed concurrently with an in situ side branch occlusion procedure. The method is preferably performed under angioscopic guidance, and the angioscope used for guidance of the method may be integrated with a separate side branch occlusion device to facilitate concurrent performance of the side branch occlusion procedure and the venous valve cutting procedure.

Method and device for endoluminal disruption of venous valves

Side branch occlusion catheter device having integrated endoscope for

A valvulotome for disrupting vein valves in in-situ procedures, and for distrupting the vein valves in vein segments to be used in CABG procedures. The valvulotome includes an elongate blade mounting member and a thin, scythe-shaped cutting blade. The cutting blade is mounted relative to the blade mounting member such that the plane defined by the blade lies on the axis defined by the blade mounting member. The cutting blade has a fixed end, a free end, a cutting edge and a blunt back edge. The fixed end is fixedly attached to a distal portion of the blade mounting member. The sharpened edge faces towards the blade mounting member, which protects the vein from the sharpened edge. The sharpened edge arcs outwards and proximally from the distal portion of the blade mounting member, and terminates in a proximal portion, spaced from the blade mounting member. The blunt back edge is opposite the sharpened edge, facing the vein. The free end is opposite the fixed end and connects the blunt back edge to the proximal portion of the sharpened edge. The free end including a blunt proximal-facing portion that forms a continuation of the blunt back edge.

Valvulotome and method of using

A percutaneous access catheter is employed for examining and treating internal body cavities and organs via an access tract. For example, the catheter can be employed for examining and treating the gallbladder via a transhepatic tract. The examination may employ endoscopic, fluoroscopic, ultrasonic, or other techniques; the treatment may employ surgical, chemical, or physical modalities. The catheter includes two inflation elements. These inflation elements control hemorrhaging and leakage of fluids from the internal body cavity or organ and reduce migration of the catheter within the internal body cavity or organ during the examination and/or treatment. The first inflation element is a toroidal elastic balloon located at the distal end of the device which serves to restrict the accidental or unintended removal of the distal end from the internal body cavity or organ. The second inflation device is an inflatable nondistensible sleeve which serves to anchor the device to the access tract during the medical procedure. The two inflation elements can act cooperatively so as to anchor the internal body cavity or organ to the access tract and so as to reduce the migration of the distal end of the device within the internal body cavity or organ. The inflation of the inflatable nondistensible sleeve can also serve to control hemorrhaging from the access tract by the application of tamponage without causing unwanted dilation thereof.

Percutaneous access catheter and method of use

An endoscope having a deflectable tip configured so as to have a small outer diameter of approximately 0.15 inch or less. The endoscope includes a flexible shaft subassembly comprised of a conduit having a deflectable end segment at its distal end which can be controlled by a manually operable mechanism on a handle subassembly. The shaft subassembly further includes a cone subassembly at its proximal end including means for structurally connecting to the handle subassembly. Illumination fibers, an imaging fiber, a pull wire and a working channel extend through the shaft subassembly from its distal end to terminals in the cone subassembly for interfacing to the handle subassembly. The handle subassembly comprises an optical component which allows for the viewing of an image emanating from the shaft subassembly imaging fiber, a deflection mechanism which incorporates a means for physical attachment and axial displacement of the shaft subassembly pull wire, and a locking mechanism for attaching the shaft subassembly to the handle subassembly.

Growing community of inventors

Oceanside, CA, United States of America

Stephen A Sosnowski