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.

1 . A system comprising 
 a guide defining an access path into a vessel or hollow body organ and including a distal region having a terminus, and    a fastener applier comprising a catheter sized and configured for introduction along the access path and including an actuated member that is selectively operable to generate an implantation force to implant within tissue at least one fastener, the catheter including 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 out of contact with tissue.    
     
     
         2 . A system according to  claim 1   wherein the guide includes a passage that defines the access path, and    wherein the catheter is sized and configured for introduction through the passage, and    wherein the indicia marks when the actuated member rests at a desired distance inset within the passage from terminus of the distal region.    
     
     
         3 . A system according to  claim 2   wherein the passage comprises an interior lumen.    
     
     
         4 . A system according to  claim 1   wherein the access path includes a proximal region having a visible entry to receive the catheter, and    wherein the indicia includes a visible marking on the catheter that visibly registers with the entry of the proximal region when the actuated member rests at the desired distance short of the terminus of the distal region.    
     
     
         5 . A system according to  claim 1   wherein the distal region is deflectable.    
     
     
         6 . A system according to  claim 1   wherein the at least one fastener comprises a tissue-piercing fastener.    
     
     
         7 . A system according to  claim 6   wherein the tissue-piercing fastener comprises a helical fastener.    
     
     
         8 . A system comprising 
 a guide defining an access path into a vessel or hollow body organ and including a distal region having a terminus,    a fastener applier comprising a catheter sized and configured for introduction along the access path and including an actuated member that is selectively operable to generate an implantation force to implant within tissue at least one fastener, the catheter including 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 out of contact with tissue, and    instructions for using the guide and fastener applier comprising introducing the guide to a location at a target site within a vessel or hollow body organ where a diseased or damaged section exists, establishing the access path to a desired fastening site at the target site by manipulating the guide to orient the terminus with respect to the desired fastening site, introducing the actuated member along the access path toward the terminus; and viewing 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.    
     
     
         9 . A method comprising 
 (i) providing a system as defined in  claim 1  or  8     (ii) introducing the guide to a location at a target site within a vessel or hollow body organ where a diseased or damaged section exists;    (iii) establishing the access path to a desired fastening site at the target site by manipulating the guide to orient the terminus with respect to the desired fastening site;    (iv) introducing the actuated member along the access path toward the terminus; and    (v) viewing 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.    
     
     
         10 . A method according to  claim 9   (vi) after (v), advancing the actuated member to the terminus of the distal region, and    (vii) operating the actuated member to generate an implantation force to implant the into tissue at the desired fastening site.    
     
     
         11 . A method according to  claim 9   wherein (iii) includes rotating the guide and/or deflecting the distal region.    
     
     
         12 . An apparatus comprising 
 a fastener applier comprising a catheter sized and configured for introduction along an access path into a vessel or hollow body organ and. including an actuated member that is selectively operable in a first direction to load at least one fastener and in a second direction to generate an implantation force to implant the fastener within tissue,    an electrically powered drive member coupled to the driven member, and    a controller coupled to the drive motor including a LOAD state including means operable 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, means for sensing electrical current delivered to the drive member while loading the fastener onto the driven member, and means for terminating 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.    
     
     
         13 . An apparatus according to  claim 12   wherein the controller includes an UNWIND state including means, operative after termination of the LOAD state, for delivering electrical current to the drive member to drive the driven member in the second direction, means for sensing a period of operation of the driven member in the second direction sufficient to reduce torque windup on the driven member during the LOAD state, means for terminating delivery of electrical current to the driven member after the period of operation, thereby terminating the UNWIND state.    
     
     
         14 . An apparatus according to  claim 13   wherein the controller includes a READY TO APPLY state including means, operative after termination of the UNWIND state, to prompt a prescribed implant fastener input command.    
     
     
         15 . An apparatus according to  claim 14   wherein the READY TO APPLY state includes means operable in response to the prescribed implant fastener input command for delivering electrical current to the drive member to drive the driven member in the second direction, means for sensing a partial period of operation of the driven member in the second direction less than a full period of operation sufficient to fully implant the fastener in tissue, means for terminating delivery of electrical current to the driven member after the partial period of operation, and means for prompting entry of either a continue implantation input command or a terminate implantation implant command.    
     
     
         16 . An apparatus according to  claim 15   wherein the READY TO APPLY STATE includes means, operative in response to the continue implantation command, for delivering electrical current to the drive member to drive the driven member in the second direction sufficient to fully implant the fastener in tissue.    
     
     
         17 . An apparatus according to  claim 15  or  16   wherein the READY TO APPLY STATE includes means, operative in response to the terminate implantation command, for delivering electrical current to the drive member to drive the driven member in the first direction sufficient to withdraw the fastener from tissue.    
     
     
         18 . A method comprising 
 (i) providing the apparatus as defined in  claim 12 ,    (ii) operating the fastener applier in the LOAD state to load a fastener onto the driven member, and    (iii) after (ii), introducing the fastener applier to a location at a target site within a vessel or hollow body organ where a diseased or damaged section exists.    
     
     
         19 . A method comprising 
 (i) providing the apparatus as defined in  claim 13 ,    (ii) operating the fastener applier in the LOAD and UNWIND states to load a fastener onto the driven member, and    (iii) after (ii), introducing the fastener applier to a location at a target site within a vessel or hollow body organ where a diseased or damaged section exists.    
     
     
         20 . A seal assembly a first seal component with at least one guide tube formed therein, 
 a second seal component with at least one guide tube formed therein, the second seal component registering 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 sandwiched between the first and second seal components, the septum accommodating passage of a 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.    
     
     
         21 . An assembly according to  claim 20   wherein at least one of the first and second seal components is substantially rigid.    
     
     
         22 . An assembly according to  claim 21   wherein the septum comprises a soft material.    
     
     
         23 . An assembly according to  claim 21   wherein the septum comprises silicone rubber.    
     
     
         24 . An assembly according to  claim 21   wherein the septum comprises a gasket.    
     
     
         25 . An assembly according to  claim 20   wherein both of the first and second seal components are substantially rigid.    
     
     
         26 . An assembly according to  claim 25   wherein the septum comprises a soft material.    
     
     
         27 . An assembly according to  claim 25   wherein the septum comprises silicone rubber.    
     
     
         28 . An assembly according to  claim 25   wherein the septum comprises a gasket.    
     
     
         29 . An apparatus comprising 
 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, and    a seal assembly between the control element and the operative element through which the control filament passes to prevent contact between the body fluid and the control element, the seal assembly comprising 
 a first seal component with at least one guide tube formed therein,  
 a second seal component with at least one guide tube formed therein, the second seal component registering 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, and  
 a septum sandwiched between the first and second seal components, the septum accommodating 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.