Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application
Reexamination Certificate
2001-03-06
2003-06-10
Joyce, Harold (Department: 3749)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Light application
Reexamination Certificate
active
06576000
ABSTRACT:
FIELD OF THE INVENTION
Devices and methods for tissue repair are described. In particular, catheters that can transmit electro-magnetic radiation (e.g., ultraviolet light) to the distal end are described. Also described are methods of using these catheters.
BACKGROUND
Catheters are increasingly used to access remote regions of the human body and, in doing so, delivering diagnostic or therapeutic agents to those sites. In particular, catheters which use the circulatory system as the pathway to these treatment sites are especially useful. For instance, it is commonplace to treat diseases of the circulatory system via angioplasty (PTA) using catheters having balloons on their distal tips. It is similarly common that those catheters are used to deliver a radio-opaque agent to that site prior to the PTA procedure to allow viewing of the problem prior to treatment. Furthermore, vaso-occlusive devices are also delivered through these catheters, for example vaso-occlusive devices such as those found in U.S. Pat. No. 4,994,069, to Ritchart et al, (vaso-occlusive coils); U.S. Pat. No. 5,122,136, to Guglielmi et al (electrolytically detachable vaso-occlusive coils); U.S. Pat. Nos. 5,226,911 and 5,304,194, to Chee et al (vaso-occlusive coils with attached fibers); U.S. Pat. No. 5,250,071, to Palermo (mechanically detachable coils); U.S. Pat. No. 5,261,916, to Engelson (mechanically detachable coil); U.S. Pat. No. 5,304,195, to Twyford et al (mechanically detachable coils); and U.S. Pat. No. 5,312,415, to Palermo (mechanically detachable coils); the entirety of which are incorporated by reference. These devices each have a relatively rigid diameter and must be pushed through the lumen of the delivery catheter.
Catheters for the delivery of these and other materials have been described, for example, in U.S. Pat. Nos. 4,739,768; 6,165,163; 6,159,187 and 6,090,099. Most of these catheters are designed to be used with a guidewire. A guidewire is simply a wire, typically of very sophisticated design, which is the “scout” for the catheter. The catheter fits over and slides along the guidewire as it passes through the vasculature. In other words, the guidewire is used to select the proper path through the vasculature with the urging of the attending physician and the catheter slides along the guidewire once the proper path is established.
Because it is often desirable to use catheters to deliver multiple components to a target site, multi-lumen catheters have also been described. For example, for sealing aneurysms, multi-part materials including vaso-occlusive coils, two-part systems (e.g., adhesive systems such as fibrin based glues), UV curable materials and the like require multi-lumen catheters for delivery of these components. In addition, many of the catheters designed to deliver multi-component systems also require at least one mixing chamber, for example for mixing fibrin glue materials in situ. Multi-lumen catheters are described, for example, in U.S. Pat. No. 5,797,869 to Martin et al.; U.S. Pat. No. 4,636,346, to Gold et al.; U.S. Pat. No. 4,840,622, to Hardy; U.S. Pat. No. 4,863,442, to DeMello et al.; and U.S. Pat. No. 5,078,702, to Pomeranz.
Catheters providing an optical fiber arranged for the transmission and emission of radiation such as UV have also been described. U.S. Pat. No. 5,860,948 describes a catheter comprising a two-lumen catheter apparatus, wherein one of the lumens is in communication with a fluid inlet port and an optical fiber.
However, none of these devices or documents describe catheters having the construction described herein. In particular, none describe a single lumen catheter used for both guidewire and for the placement of soft, photocurable material.
SUMMARY OF THE INVENTION
Thus, this invention includes novel devices as well as methods of using and making these devices.
In one aspect, the invention includes a single-lumen catheter comprising at least one source of electro-magnetic radiation (e.g., ultraviolet light) disposed in the wall of the catheter. In certain embodiments, the source of electro-magnetic radiation is integral to the catheter, for example at the distal end of the catheter. In other embodiments, the source of electro-magnetic radiation comprises a transmission device within the wall of the catheter. The transmission device can then be operably linked to a source of electro-magnetic radiation that is external to the catheter. The electro-magnetic radiation transmission may comprise one or more fiber optic cables; one or more light-transmitting fluids; one or more light-transmitting wires or combinations thereof. Furthermore, the invention can include multiple sources of electro-magnetic radiation (e.g., integral or external source with integral transmission devices) disposed in the wall of the catheter, for example, adjacent to each other or on one or more different sides of the catheter body.
In preferred embodiments, any of the devices and assemblies described herein are used in combination with a source of photopolymerizable material such as polyethyleneglycol diacrylate; poly(ethylene glycol) central block molecules, extended with hydrolyzable oligomers (e.g., oligo(d,l-lactic acid) and oligo(glycolic acid)) and terminated with acrylate groups; and polyethylene glycol tetraacrylate (e.g., initiated with triethanolamine, N-vinylpyrollidone, and/or eosin Y). Photopolymerizable material is preferably suitable for deposition at the target site and wherein electro-magnetic radiation emitted from the source of electro-magnetic radiation disposed in the wall of the catheter polymerizes the photopolymerizable material as it is extruded from the catheter.
In another aspect, the invention includes an assembly for use in depositing material in a vessel comprising any one of the devices described herein; a photopolymerizable material; and
a source of electro-magnetic radiation (e.g., ultraviolet light). Thus, in certain embodiments, the source of electro-magnetic radiation is disposed within the wall of the catheter at the distal end of the assembly while in other embodiments, the source of electro-magnetic radiation comprises at least one electro-magnetic radiation transmission device (e.g., one or more fiber optic cable; one or more light-transmitting fluids; and/or one or more light-transmitting wires) disposed within the wall of the catheter and operably linked to an external source of electro-magnetic radiation.
In other embodiments, any of the assemblies described herein further comprise one or more additional bioactive material(s) and/or one or more implantable devices (e.g., vaso-occlusive devices, stents, filters, etc.).
In another aspect, the invention includes a method of occluding an aneurysm comprising administering, to a subject in need thereof, a photopolymerizable material using any of the catheters or assemblies described herein.
These and other embodiments of the subject invention will readily occur to those of skill in the art in light of the disclosure herein.
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Boles Derek
Joyce Harold
Robins & Pasternak LLP
Sci-Med Life Systems, Inc.
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