| Delivery system and method of use for deployment of self-expandable vascular device -> Monitor Keywords |
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Delivery system and method of use for deployment of self-expandable vascular deviceRelated Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Arterial Prosthesis (i.e., Blood Vessel), Stent Combined With Surgical Delivery System (e.g., Surgical Tools, Delivery Sheath, Etc.)Delivery system and method of use for deployment of self-expandable vascular device description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070016280, Delivery system and method of use for deployment of self-expandable vascular device. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] This application is a non-provisional application of U.S. provisional patent application Ser. No. 60/699,151 filed Jul. 14, 2005, the entire contents of which is hereby incorporated by reference. FIELD OF THE INVENTION [0002] The present invention relates to a delivery system and method for deployment of a vascular device and, more particularly, to a delivery system and method for deployment of a self-expanding vascular device. BACKGROUND OF THE INVENTION [0003] Tubular prostheses typically fall into two general categories of construction. The first category of prosthesis is expandable upon application of a controlled force, often through the inflation of the balloon portion of a dilatation catheter, which expands the compressed prosthesis to a larger diameter to be left in place within a vessel, e.g., an artery, at the target site. The second category of prosthesis is a self-expanding prosthesis formed from, for example, shape memory metals or super-elastic Nickel-Titanium (NiTi) alloys, that will automatically expand from a compressed state when the prosthesis is advanced out of the distal end of the delivery catheter into the blood vessel. [0004] Some known prosthesis delivery systems for implanting self-expanding stents include an inner lumen upon which the compressed or collapsed prosthesis is mounted and an outer restraining sheath that is initially placed over the compressed prosthesis prior to deployment. When the prosthesis is to be deployed in the body vessel, the outer sheath is moved in relation to the inner lumen to "uncover" the compressed prosthesis, allowing the prosthesis to move to its expanded condition. Some delivery systems utilize a "push-pull" design and technique in which the outer sheath is retracted while the inner lumen is pushed forward. Still other systems use an actuating wire that is attached to the outer sheath. When the actuating wire is pulled to retract the outer sheath and deploy the prosthesis, the inner lumen must remain stationary, to prevent the prosthesis from moving axially within the body vessel. [0005] There have been, however, problems associated with these delivery systems. Systems that use the "push-pull" design can experience movement of the collapsed prosthesis within the body vessel when the inner lumen is pushed forward. This movement can lead to inaccurate positioning and, in some instances, possible perforation of the vessel wall by a protruding end of the prosthesis. Further, systems that utilize the actuating wire design will tend to move to follow the radius of curvature when placed in curved anatomy of the patient. As the wire is actuated, tension in the delivery system can cause the system to straighten. As the system straightens, the position of the prosthesis changes because the length of the catheter no longer conforms to the curvature of the anatomy. This change of the geometry of the system within the anatomy also leads to inaccurate prosthesis positioning. [0006] Systems are known for delivering or implanting a self-expanding device in a vessel by operation of a balloon to rupture a sheath that holds the self-expanding device in a compressed state. When the device is located at the desired position in the vessel, the balloon is inflated, rupturing the sheath, thereby allowing the device to expand into position. Examples of these systems include U.S. Pat. No. 6,656,213 to Solem and U.S. Pat. No. 5,549,635 to Solar. [0007] While Solem '213 and Solar '635 describe systems for delivering a self-expanding stent by operation of a balloon to rupture a sheath, experimental implementations of systems of these types of systems have shown results that fall short of expectations. In experiments on porcine coronary arteries, withdrawal of the catheter delivery system after sheath rupturing resulted in migration of the stent from the target implant position. The amount of stent migration was unpredictable and was in the range of 3-10 mm, which is suboptimal for the treatment of coronary lesions. [0008] There are two primary structural factors that lead to stent migration for these systems. First the stent may remain circumferentially enclosed by the sheath at points along its length even after sheath rupture, i.e., the stent may not fully exit the sheath. Secondly, the friction between the sheath and the stent during catheter removal may drag the stent proximally. The inability of these systems to offer accurate placement of a stent at a target site causes this approach to be not optimum for treatment of coronary lesions and similar stenotic disease states. [0009] There is thus a widely recognized need for, and it would be highly advantageous to have, a delivery system that is devoid of the above limitations. SUMMARY OF THE INVENTION [0010] According to one aspect of the present invention there is provided a delivery system for a self-expanding prosthesis, comprising: a catheter having a distal portion and a proximal portion; a balloon portion positioned near the distal portion of the catheter; a self-expanding device having a compressed state and an expanded state positioned about the balloon portion; and a sheath coupling the device in its compressed state about the balloon portion, the sheath having a proximal end and a distal end, the proximal end of the sheath fixed to the catheter at a location on the catheter proximal to the balloon portion, wherein the self-expanding device comprises a flared portion and a stem portion that, in the expanded state, expand, respectively, to a first diameter and a second diameter, the first diameter being larger than the second diameter, and wherein the self-expanding device is oriented about the balloon portion such that the flared portion is oriented toward the proximal portion of the catheter and the stem portion is oriented toward the distal portion of the catheter. [0011] According to another aspect of the present invention, there is provided a method of inserting a self expanding ostial protection device (OPD) into a side branch vessel from a main branch vessel at an ostium, the method comprising: providing an OPD delivery system comprising: a catheter having a distal portion and a proximal portion; a balloon portion positioned on the distal portion of the catheter; a self expanding OPD having a compressed state and an expanded state positioned about the balloon portion; and a sheath coupling the OPD in its compressed state about the balloon portion, the sheath having a proximal end and a distal end, the distal end fixed to the catheter at a location on the catheter distal to the balloon portion. Further, inserting the catheter into a side branch vessel, from a main branch vessel, to a desired position in the side branch vessel; expanding the balloon portion such that the sheath is ruptured and the OPD is allowed to expand to its expanded state and a portion of the OPD engages an inner wall of the side branch vessel; deflating the balloon portion; inserting the catheter distally further into the side branch vessel a distance sufficient to remove the ruptured sheath from between the expanded OPD and the side branch vessel wall; and withdrawing the catheter proximally through the expanded OPD whereby the OPD is deployed at the desired position in the side branch vessel. [0012] According to another aspect of the present invention, there is provided a method of inserting a self expanding ostial protection device (OPD) into a side branch vessel from a main branch vessel at an ostium, the method comprising: providing an OPD delivery system comprising: a catheter having a distal portion and a proximal portion; a balloon portion positioned on the distal portion of the catheter; a self expanding OPD having a compressed state and an expanded state positioned about the balloon portion; and a sheath coupling the OPD in its compressed state about the balloon portion, the sheath having a proximal end and a distal end, the proximal end fixed to the catheter at a location on the catheter proximal to the balloon portion, wherein the self-expanding OPD comprises a flared portion and a stem portion that, in the expanded state, expand, respectively, to a first diameter and a second diameter, the first diameter being larger than the second diameter, and wherein the self-expanding OPD is oriented about the balloon portion such that the flared portion is oriented toward the proximal portion of the catheter and the stem portion is oriented toward the distal portion of the catheter. Further, inserting the catheter into a side branch vessel, from a main branch vessel, to a desired position in the side branch vessel; expanding the balloon portion such that the sheath is ruptured and the OPD is allowed to expand to its expanded state and a portion of the OPD engages an inner wall of the side branch vessel; deflating the balloon portion; and withdrawing the catheter proximally from the side branch vessel whereby the OPD is deployed at the desired position in the side branch vessel and the sheath is withdrawn from the side branch vessel. [0013] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the present invention, suitable methods and materials are described below. In case of conflict, the specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. BRIEF DESCRIPTION OF THE DRAWINGS [0014] The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the various embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. [0015] In the drawings: [0016] FIG. 1A is a longitudinal cross-sectional illustration of a delivery system in accordance with one embodiment of the present invention; [0017] FIG. 1B is a transverse cross-sectional illustration of a delivery system in accordance with the embodiment shown in FIG. 1A; [0018] FIGS. 2A-2C are perspective illustrations of a distal end of a catheter having a sheath and showing openings on the sheath; [0019] FIG. 3A is a longitudinal cross-sectional illustration of a delivery system in accordance with another embodiment of the present invention; Continue reading about Delivery system and method of use for deployment of self-expandable vascular device... 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