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  Systems and methods for attaching a prosthesis within a body lumen or hollow organUSPTO Application #: 20060020326Title: Systems and methods for attaching a prosthesis within a body lumen or hollow organ Abstract: Systems and methods introduce and deploy prosthesis into a blood vessel or hollow body organ by intra-vascular access. The prosthesis is secured in place by fasteners which are implanted by an applier that is also deployed by intra-vascular access. The applier is configured to permit controlled, selective release of the fastener in a step that is independent of the step of implantation. (end of abstract)
Agent: Ryan Kromholz & Manion, S.c. - Milwaukee, WI, US Inventors: Lee Bolduc, Phil Houle USPTO Applicaton #: 20060020326 - Class: 623001230 (USPTO) Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Arterial Prosthesis (i.e., Blood Vessel), Including Means For Graft Delivery (e.g., Delivery Sheath, Ties, Threads, Etc.) The Patent Description & Claims data below is from USPTO Patent Application 20060020326. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] This application claims the benefit of U.S. patent application Ser. No. 10/693,255, filed Oct. 24, 2003, and entitled "Multi-Lumen Prosthesis Systems and Methods." This application also claims the benefit of U.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002, and entitled "Intraluminal Prosthesis Attachment Systems and Methods." FIELD OF THE INVENTION [0002] The invention relates generally to prostheses, and in particular, the attachment of prostheses used in the repair of diseased and/or damaged sections of a hollow body organ and/or a blood vessel. BACKGROUND OF THE INVENTION [0003] The weakening of a vessel wall from damage or disease can lead to vessel dilatation and the formation of an aneurysm. Left untreated, an aneurysm can grow in size and may eventually rupture. [0004] For example, aneurysms of the aorta primarily occur in abdominal region, usually in the infrarenal area between the renal arteries and the aortic bifurcation. Aneurysms can also occur in the thoracic region between the aortic arch and renal arteries. The rupture of an aortic aneurysm results in massive hemorrhaging and has a high rate of mortality. [0005] Open surgical replacement of a diseased or damaged section of vessel can eliminate the risk of vessel rupture. In this procedure, the diseased or damaged section of vessel is removed and a prosthetic graft, made either in a straight of bifurcated configuration, is installed and then permanently attached and sealed to the ends of the native vessel by suture. The prosthetic grafts for these procedures are usually unsupported woven tubes and are typically made from polyester, ePTFE or other suitable materials. The grafts are longitudinally unsupported so they can accommodate changes in the morphology of the aneurysm and native vessel. However, these procedures require a large surgical incision and have a high rate of morbidity and mortality. In addition, many patients are unsuitable for this type of major surgery due to other co-morbidities. [0006] Endovascular aneurysm repair has been introduced to overcome the problems associated with open surgical repair. The aneurysm is bridged with a vascular prosthesis, which is placed intraluminally. Typically these prosthetic grafts for aortic aneurysms are delivered collapsed on a catheter through the femoral artery. These grafts are usually designed with a fabric material attached to a metallic scaffolding (stent) structure, which expands or is expanded to contact the internal diameter of the vessel. Unlike open surgical aneurysm repair, intraluminally deployed grafts are not sutured to the native vessel, but rely on either barbs extending from the stent, which penetrate into the native vessel during deployment, or the radial expansion force of the stent itself is utilized to hold the graft in position. These graft attachment means do not provide the same level of attachment when compared to suture and can damage the native vessel upon deployment. SUMMARY OF THE INVENTION [0007] The invention provides apparatus, tools, systems, and methods for repairing diseased and/or damaged sections of a hollow body organ and/or a blood vessel. The apparatus, tools, systems, and methods find use, e.g., in the introduction and deployment of a prosthesis into a blood vessel or hollow body organ, which desirably is achieved by intra-vascular access. The prosthesis is secured in place by fasteners, which are implanted by the apparatus, tools, systems, and methods that embody one or more features of the invention, which are also desirably deployed by intra-vascular access. [0008] According to one aspect of the invention, the applier is configured to permit controlled, selective release of the fastener in a step that is independent of the step of implantation. According to one embodiment of this aspect of the invention, the applier includes a driven member that is carried on a tool body. The tool body can include, e.g., a tube, such as a catheter, to permit intra-vascular deployment of the driven member. The driven member is operable to apply an implantation force to the fastener. A drive actuator operates the driven member. The applier also includes a fastener-engaging mechanism on the driven member. The mechanism is operable in a first condition to couple the fastener to the driven member to transfer the implantation force from the driven member to the fastener. Implantation of the fastener can thereby be achieved. The mechanism is also operable in a second condition to release the fastener from the driven member. According to this aspect of the invention, the mechanism includes a second actuator, which places the mechanism in the second condition, to release the fastener. The second actuator is operable independent of the drive actuator. There can thus be a definite, stepwise separation between implanting the fastener in tissue using the implantation tool and releasing the fastener from the implantation tool after implantation is satisfactorily achieved. [0009] Another aspect of the invention provides a tool that can be used to apply an implantation force to a fastener, which is sized and configured for implantation in tissue in response to an implantation force applied according to prescribed conditions. The tool is coupled to a controller, which interrupts implantation before it is completed, and interjects a "go"/"no go" decision-making step before proceeding further. The tool includes a driven member carried on a tool body. The tool body can comprise, e.g., a tube, such as a catheter. The driven member is operable to apply the implantation force. A mechanism on the driven member couples the fastener to the driven member to transfer the implantation force from the driven member to the fastener. According to this aspect of the invention, a controller is coupled to the driven member. The controller executes differing operational phases during the implantation process. During an initial phase the driven member is operated to apply the implantation force under conditions that do not achieve the prescribed conditions, so that only partial implantation of the fastener occurs. A lull phase commences at the end of the initial phase. The lull phase interrupts operation of the driven member. There is a final phase, which operates the driven member under conditions that supplement the conditions of the initial phase to achieve the prescribed conditions, and thus achieve complete implantation. However, the controller requires, after the initial phase, a prescribed command to advance from the lull phase to the final phase. The lull phase requires a decision be made before implantation of the fastener is finalized. If implantation during the initial phase is deemed not to be satisfactory, implantation can be aborted, and the fastener (now only partially implanted) can be withdrawn. The decision can comprise a conscious decision by the operator and/or a decision based, at least in part, upon physuical or operational conditions sensed during the initial phase. [0010] Another aspect of the invention provides a tool for applying an implantation force to a fastener that is sized and configured for implantation in tissue in response to an implantation force. The tool comprises a driven member carried on a tool body that is operable to apply the implantation force. According to this aspect of the invention, an element is included that tethers the fastener to the tool body. The tethering element safeguards against inadvertent loss of the fastener prior to implantation. The tethering element includes a frangible portion, so that, once the fastener is satisfactorily implanted, the tethering element can be parted from the fastener and the tool body removed. [0011] The invention also provides various systems and methods for using the above-described devices to implant tissue in a vessel or hollow body organ. [0012] Other features and advantages of the invention shall be apparent based upon the accompanying description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The invention will be understood from the following detailed description of preferred embodiments, taken in conjunction with the accompanying drawings, wherein: [0014] FIG. 1 is a perspective view of a prosthesis having a fastening region that accommodates the introduction of one or more fasteners. [0015] FIG. 2 is a perspective view of the prosthesis shown in FIG. 1, showing the attachment of fasteners in the fastening region. [0016] FIG. 3 is a perspective view of the prosthesis shown in FIG. 1 positioned within an abdominal aortic aneurysm. [0017] FIG. 4 is a perspective view of the prosthesis shown in FIG. 3 as it is being deployed by an intra-vascular catheter. [0018] FIG. 5 is a perspective view of the prosthesis shown in FIG. 3 after it been deployed and as fasteners are being implanted by an intra-vascular fastener applier. [0019] FIG. 6. is a side view, partly broken away and in section, of an intra-vascular fastener applier that can be used to implant fasteners in the prosthesis shown in FIGS. 1 and 2, in the manner shown in FIG. 5. Continue reading... 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