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03/29/07 - USPTO Class 623 |  46 views | #20070073389 | Prev - Next | About this Page  623 rss/xml feed  monitor keywords

Endovascular aneurysm devices, systems, and methods

USPTO Application #: 20070073389
Title: Endovascular aneurysm devices, systems, and methods
Abstract: Devices, systems, and methods for implanting prostheses in the body lumens rely on tacking or anchoring the prostheses with separately introduced fasteners. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners to at least one prosthesis end. The fasteners are usually helical fasteners which are releasably restrained on the fastener driver, and are delivered by rotation of the fastener driver. The fasteners may be applied singly, typically in circumferentially spaced-apart patterns about the interior of at least one end of the prosthesis. A lumen extension or lumens may be coupled to the prosthesis to extend the reach of the prosthesis within the implantation site. Fasteners may also be applied to the lumen extensions. (end of abstract)



Agent: Ryan Kromholz & Manion, S.c. - Milwaukee, WI, US
Inventors: Lee Bolduc, Andrew L. Chiang, Jimmy Jen, Joshua Stafford
USPTO Applicaton #: 20070073389 - Class: 623001360 (USPTO)

Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Arterial Prosthesis (i.e., Blood Vessel), With Means To Attach Graft To Natural Blood Vessel (e.g., Hooks, Etc.)

Endovascular aneurysm devices, systems, and methods description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20070073389, Endovascular aneurysm devices, systems, and methods.

Brief Patent Description - Full Patent Description - Patent Application Claims
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RELATED APPLICATIONS

[0001] This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled "Devices, Systems, and Methods for Prosthesis Delivery and Implantation," which is incorporated herein by reference. This application also is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/692,283, filed Oct. 23, 2003, and entitled "Prosthesis Delivery Systems and Methods," which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/488,753, filed Jul. 21, 2003, and entitled "Endoprosthesis Delivery Systems and Methods." This application also is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/786,465, filed Feb. 25 2004, and entitled "Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ." This application is also a continuation-in-part of co-pending U.S. patent application Ser. No. 11/693,255, filed Jun. 24, 2005, entitled "Multi-Lumen Prosthesis Systems and Methods," which is a division of U.S. patent application Ser. No. 10/693,255, filed 24 Oct. 2003 (now U.S. Pat. No. 6,929,661), which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/489,011, filed Jul. 21, 2003, and entitled "Bifurcated Prosthesis Systems and Methods." This application also is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/307,226, filed 29 Nov. 2002, and entitled "Intraluminal Prosthesis Attachment Systems and Methods." This application is also a continuation-in-part of copending U.S. patent application Ser. No. 10/669,881, entitled "Catheter-Based Fastener Implantation Apparatus and Methods with Implantation Force Resolution." This application is also a continuation-in-part of copending U.S. patent application Ser. No. 11/166,411, filed Jun. 24, 2005, entitled "Endovascular Aneurysm Repair System," which is a division of U.S. patent application Ser. No. 10/271,334, filed 15 Oct. 2002 (now U.S. Pat. No. 6,960,217), which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/333,937, filed 28 Nov. 2001, and entitled "Endovascular Aneurysm Repair System." Each of the preceding applications is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The invention relates generally to devices, systems, and methods for the delivery and implantation of a prosthesis to a targeted site within the body, e.g., for the repair of diseased and/or damaged sections of a hollow body organ and/or 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 the 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 prosthesis, made either in a straight or bifurcated configuration, is installed and then permanently attached and sealed to the ends of the native vessel by suture. The prosthesis for these procedures are usually unsupported woven tubes and are typically made from polyester, ePTFE or other suitable materials. The prosthesis 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 prostheses for aortic aneurysms are delivered collapsed on a catheter through the femoral artery. These prostheses 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 prostheses 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 prosthesis in position. These prosthesis attachment means do not provide the same level of attachment when compared to suture and can damage the native vessel upon deployment.

[0007] Accordingly, there is a need for improved prosthesis delivery devices, systems, and methods that deliver a prosthetic graft to a body lumen, the prosthesis being able to adapt to changes in aneurysm morphology and able to be deployed safely and without damage to the native vessel.

SUMMARY OF THE INVENTION

[0008] One aspect of the invention provides a system comprising a guide defining an access path into a vessel or hollow body organ and a fastener applier comprising a catheter sized and configured for introduction along the access path to a site targeted for implantation of at least one fastener. The guide includes a distal region with terminus. The fastener applier includes an actuated member that is selectively operable to generate an implantation force to implant the at least one fastener within tissue at the site. According to this aspect of the invention, the catheter includes indicia visible to a naked eye to mark when the actuated member rests at a desired distance along the access path short of the terminus of the distal region and is therefore still out of contact with tissue. The visible indicia makes it possible for the physician, without resort to fluoroscopic visualization or other visualizations techniques that augment human sight, to always know whether the fastener is within or outside the guide.

[0009] This aspect of the invention also provides instructions for using the guide and fastener applier in which, as the actuated member is being introduced along the access path toward the terminus, the operator or physician is instructed to view the indicia with a naked eye, to detect when the actuated member rests at a desired distance along the access path short of the terminus of the distal region.

[0010] Another aspect of the invention provides for a fastener applier an electrically powered drive member coupled to the driven member and a controller coupled to the drive motor. According to this aspect of the invention, the controller includes a LOAD state. In the LOAD state, the controller operates in response to an input command for delivering electrical current to the drive member to drive the driven member in a first direction to load a fastener onto the driven member. The controller senses electrical current delivered to the drive member while loading the fastener onto the driven member. The controller terminates delivery of electrical current to the driven member when a prescribed amount of current is delivered to the drive member, thereby terminating the LOAD state.

[0011] On one embodiment, the controller also includes an UNWIND state that follows the LOAD state. In the UNWIND state, which is operative after termination of the LOAD state, the controller delivers electrical current to the drive member to drive the driven member in a second direction. The controller senses a period of operation of the driven member in the second direction which is sufficient to reduce torque windup on the driven member created during the LOAD state. The controller terminates delivery of electrical current to the driven member after the period of operation, thereby terminating the UNWIND state. According to this aspect of the invention, the fastener applier enters a READY TO APPLY state with a minimum of torque windup associated with the driven element.

[0012] Another aspect of the invention provides a fluid seal assembly usable in association with, e.g., a catheter assembly including an operative element that, in use, is exposed to a body fluid, a control element, a control filament coupled at one end to the control element and to an opposite end to the operative element. In this arrangement, the seal assembly is positioned between the control element and the operative element, and the control filament passes through the seal assembly to prevent contact between the body fluid and the control element.

[0013] According to this aspect of the invention, the seal assembly comprises a first seal component with at least one guide tube formed therein, and a second seal component with at least one guide tube formed therein. The second seal component registers with the first seal component with at least one guide tube in the second component coaxially aligned with at least one guide tube in the first component. A septum is sandwiched between the first and second seal components. The septum accommodates passage of the control filament from one the coaxially aligned guide tubes, through the septum, to the other one of the coaxially aligned guide tubes, thereby providing a fluid seal for the control filament that prevents the control element from contacting body fluid to which the operative element is exposed during use.

[0014] Other features and advantages of the invention shall be apparent based upon the accompanying description, drawings, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 is a view of the components of a system for repairing an endovascular aneurysm.

[0016] FIG. 2 is a view of the components of the system shown in FIG. 1 consolidated for use in a multiple piece kit, along with instructions for their use.

[0017] FIG. 3A is a view of the main body of the endovascular graft that forms a part of the system shown in FIG. 1.

[0018] FIG. 3B is a view of a lumen extension of the endovascular graft that forms a part of the system shown in FIG. 1.

[0019] FIG. 3C is an anatomic view of the main body and lumen extensions of the graft assembly assembled within an abdominal aortic aneurysm.

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Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor

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