Abstract:
A method of attaching a prosthesis to soft tissue is provided and includes providing a handheld fastener applier having a drive mechanism; and a fastener disposed at a distal end of the applier. The fastener includes a continuous helical coil, wherein the helical coil is constructed from a first material; and a cap secured to a proximal end of the helical coil, wherein the cap is constructed from a second material, and wherein the cap is non-rotatably and selectively connected to the drive mechanism. The fastener applier further includes a fastener driver coupled to the drive mechanism and engaging the cap, wherein the fastener driver rotates the fastener when the drive mechanism is actuated. The method further includes placing the distal end of the applier against a prosthesis; and manually powering the drive mechanism to actuate the fastener driver, and in turn, to rotate the fastener connected thereto.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a divisional of co-pending U.S. patent application Ser. No. 10/669,881, filed Sep. 24, 2003, entitled “Catheter-Based Fastener Implantation Apparatus and Methods With Implantation Force Resolution, which is a continuation-in-part of U.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002, and which is also a continuation-in-part of U.S. patent application Ser. No. 10/271,334, filed Oct. 15, 2002 (now U.S. Pat. No. 6,960,217), and which is also a continuation-in-part of U.S. patent application Ser. No. 10/099,149, filed Mar. 15, 2002, which is a divisional of U.S. patent application Ser. No. 09/787,135, filed Sep. 17, 1999, entitled “Endovascular Fastener Applicator,” which claims the benefit of U.S. Provisional Application Ser. No. 60/101,050 filed Sep. 18, 1998. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention relates generally to the delivery 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 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 and methods for implanting a fastener in a targeted body region, e.g., within a hollow body organ or an intraluminal space. 
         [0008]    One aspect of the invention provides an intraluminal fastener applier comprising a guide body having a longitudinal axis sized and configured for intraluminal deployment in a hollow body organ. The fastener applier includes an actuated assembly carried by the guide body that is selectively operable to generate an implantation force to implant at least one fastener into tissue within the hollow body organ. The actuated assembly includes a driven member extending generally along the longitudinal axis, which is sized and configured to engage a selected fastener. The actuated assembly also includes a drive member coupled to the driven member to impart the implantation force to the driven element in a direction that is at an angle to the longitudinal axis of the guide body. 
         [0009]    In one embodiment, the actuated assembly includes structure that maintains the angle between the driven member and the drive member at about ninety-degrees or less. 
         [0010]    In one embodiment, the actuated assembly includes structure that maintains a fixed angle between the driven member and the drive member, which can be, e.g., ninety-degrees or less. 
         [0011]    In one embodiment, the actuated assembly includes a control mechanism to articulate the driven member relative to the drive member to adjust the angle. 
         [0012]    In one embodiment, stabilization means is associated with the guide body for applying a resolving force in a direction different than the implantation force direction to resolve at least a portion of the implantation force within the hollow body organ. 
         [0013]    Another aspect of the invention provides a method that deploys an intraluminal fastener applier hollow body organ. The intraluminal fastener applier comprises a guide body having a longitudinal axis sized and configured for intraluminal deployment in a hollow body organ. The fastener applier includes an actuated assembly carried by the guide body that is selectively operable to generate an implantation force to implant at least one fastener into tissue within the hollow body organ. The actuated assembly includes a driven member extending generally along the longitudinal axis, which is sized and configured to engage a selected fastener. The actuated assembly also includes a drive member coupled to the driven member to impart the implantation force to the driven element in a direction that is at an angle to the longitudinal axis of the guide body. 
         [0014]    The method places the driven member into contact with tissue along a side wall of the hollow body while the longitudinal axis of the guide body remains substantially aligned with a long axis of the hollow body organ. The method operates the drive member to impart the implantation force to the driven element in the direction that is at an angle to the longitudinal axis of the guide body, to thereby implant the fastener in the side wall while the guide body remains substantially aligned with the long axis of the hollow body organ. 
         [0015]    In one embodiment, the method applies a resolving force at or near the drive member to resolve within the hollow body organ at least a portion of the implantation force. 
         [0016]    In one embodiment, the guide body includes a catheter body having a column strength that applies a resolving force in a direction different than the implantation force direction to resolve at least a portion of the implantation force within the hollow body organ. 
         [0017]    Another aspect of the invention provides a method that advances an intraluminal fastener applier to a location within a prosthesis that has been deployed at a target site along a side wall of an aorta where a diseased or damaged section exists. The intraluminal fastener applier comprises a guide body having a longitudinal axis sized and configured for intraluminal deployment in a hollow body organ. The fastener applier includes an actuated assembly carried by the guide body that is selectively operable to generate an implantation force to implant at least one fastener into tissue within the hollow body organ. The actuated assembly includes a driven member extending generally along the longitudinal axis, which is sized and configured to engage a selected fastener. The actuated assembly also includes a drive member coupled to the driven member to impart the implantation force to the driven element in a direction that is at an angle to the longitudinal axis of the guide body. 
         [0018]    The method places the driven member in alignment with a desired fastening site on the prosthesis along the side wall of the aorta. Due to the angle, the longitudinal axis of the guide body remains substantially aligned with a long axis of the aorta. The method anchors the prosthesis to a side wall of the aorta by operating the drive member to impart the implantation force to the driven element in the direction that is at an angle to the longitudinal axis of the guide body. The method thereby implants the fastener into tissue in a side wall of the aorta, while the longitudinal axis of the guide body remains substantially aligned with a long axis of the aorta. 
         [0019]    In one embodiment, the method applies a resolving force at or near the drive member to resolve within the aorta at least a portion of the implantation force. 
         [0020]    In one embodiment, the guide body includes a catheter body having a column strength that applies a resolving force in a direction different than the implantation force direction to resolve at least a portion of the implantation force within the aorta. 
         [0021]    According to any aspect of the invention, the fastener includes a tissue-piercing fastener having a sharpened distal tip for piercing and penetrating tissue. The tissue-piercing fastener can comprise, e.g., a helical fastener. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    The invention will be understood from the following detailed description of preferred embodiments, taken in conjunction with the accompanying drawings, wherein: 
           [0023]      FIG. 1  is a perspective view of one embodiment of an endovascular graft delivery device shown positioned within an abdominal aortic aneurysm; 
           [0024]      FIG. 2  is a perspective view of one embodiment the deployment of an endovascular graft within the aneurysm of  FIG. 1 ; 
           [0025]      FIG. 3  is a perspective view of a fully deployed straight endovascular graft of  FIG. 2 ; 
           [0026]      FIG. 4  is a perspective view of a fully deployed bifurcated endovascular graft broken away to show an anchoring scaffold at one end; 
           [0027]      FIG. 5  is a perspective view similar to  FIG. 5  showing an alternative scaffold structure; 
           [0028]      FIG. 6  is a perspective view showing one embodiment of a device for directing the fastener applier; 
           [0029]      FIG. 7  is a perspective view showing the device of  FIG. 6  upon insertion within the deployed endovascular graft of  FIG. 3  with both the graft and scaffolding broken away; 
           [0030]      FIG. 8  is a perspective view of the device of  FIG. 6  showing activation of one embodiment of a stabilizing device attached to the directing device; 
           [0031]      FIG. 9  is a perspective view of the control assembly in  FIG. 8  articulating the directing device of  FIG. 6 ; 
           [0032]      FIG. 10  is a perspective view of an alternative embodiment of the stabilization device of  FIG. 8 ; 
           [0033]      FIG. 11  is a perspective view showing the activation of the alternative stabilization device of  FIG. 10 ; 
           [0034]      FIG. 12  is a perspective view showing another embodiment of the stabilization device of  FIG. 8 ; 
           [0035]      FIG. 13  is a perspective view showing activation of the stabilization device of  FIG. 12 ; 
           [0036]      FIG. 14  is one embodiment of the fastener applier; 
           [0037]      FIG. 14A  is an enlarged view of the distal end of the fastener applier shown in  FIG. 14 , showing the details of the fastener drive mechanism; 
           [0038]      FIG. 14B  is a section view of the interior of the handle of the fastener applier shown in  FIG. 14 ; 
           [0039]      FIG. 15  is a perspective view of the fastener applier of  FIG. 14  being positioned within directing device of  FIG. 6 ; 
           [0040]      FIG. 16  is an enlarged cross-sectional view of one embodiment of the fastener applier of  FIG. 14 ; 
           [0041]      FIG. 17  is an enlarged cross-sectional view of the attachment applier showing one embodiment of the proximal end of the helical fastener and the drive mechanism; 
           [0042]      FIG. 18  is a enlarged perspective view of one embodiment of the helical fastener of  FIG. 16 ; 
           [0043]      FIG. 19  is an enlarged view of the attachment applier showing one embodiment of the control assembly that activates the fastener applier; 
           [0044]      FIG. 20  is an enlarged view of the attachment applied activated with a fastener implanted into the graft and vessel wall; 
           [0045]      FIG. 21  is an enlarged view of the completed attachment of the proximal graft of  FIG. 3  to the vessel wall with fasteners; 
           [0046]      FIG. 22  is a perspective view of the graft of  FIG. 4  completely attached to the vessel; 
           [0047]      FIG. 23  is an enlarged section view of the drive mechanism of the fastener applier shown in  FIG. 14 , showing a contact/force sensing assembly that disables the applier in the absence of desired contact between the fastener and a targeted tissue region; 
           [0048]      FIG. 24  is an enlarged section view of the drive mechanism of the fastener applier shown in  FIG. 14 , showing the contact/force sensing assembly enabling use of the applier in response to desired contact between the fastener and the targeted tissue region; 
           [0049]      FIGS. 25A and 25B  are enlarged views of the distal end of a fastener applier showing the details of an alternative embodiment of the fastener drive mechanism; 
           [0050]      FIG. 26A  is an enlarged section view of the drive mechanism of the fastener applier shown in  FIGS. 25A and 25B  showing a contact/force sensing assembly that disables the applier in the absence of desired contact between the fastener and a targeted tissue region; 
           [0051]      FIGS. 26B and 26C  are enlarged section views of the drive mechanism of the fastener applier shown in  FIGS. 25A and 25B , showing the contact/force sensing assembly enabling use of the applier in response to desired contact between the fastener and the targeted tissue region; 
           [0052]      FIG. 27  is a perspective view of a helical fastener that can be used in association with the fastener applier shown in  FIGS. 14 ,  23 , and  24 ; 
           [0053]      FIG. 28A  is a perspective view of a helical fastener that can be used in association with the fastener applier shown in  FIGS. 25A and 25B ; 
           [0054]      FIG. 28B  is perspective view of a helical fastener that can be used in association with the fastener applier shown in  FIGS. 26A to 26C ; 
           [0055]      FIG. 29  is an enlarged side view, partially in section, of a fastener applier having an angled applicator end that can be used to deploy the helical fastener shown in  FIG. 27  without use of a separate directing device; 
           [0056]      FIG. 30  is an enlarged side view, partially in section, of an alternative embodiment of an angled fastener applier that can be used to deploy the helical fastener shown in  FIG. 27  without use of a separate directing device; 
           [0057]      FIG. 31  is an enlarged side view, partially in section, of an alternative embodiment of an angled fastener applier that can be used to deploy the helical fastener shown in  FIG. 27  without use of a separate directing device, the fastener applier having an articulating applicator end; 
           [0058]      FIG. 32  is a perspective view of an endovascular prosthesis shown positioned within an abdominal aortic aneurysm, the prosthesis including an integrated fastener assembly; 
           [0059]      FIG. 33  is a perspective view of the endovascular prosthesis shown in  FIG. 32 , with an intraluminal tool deployed to operatively interact with the integrated fastener assembly, to temporarily or permanently anchor the prosthesis to the wall of the vessel; 
           [0060]      FIG. 34  is a side view of a fastener that forms a part of the integrated fastener assembly shown in  FIG. 33 , the fastener having a stem, which is shown in a normally spread-apart condition before its association with the integrated fastener assembly; 
           [0061]      FIG. 35  is a side view of the fastener shown in  FIG. 34 , the fastener stem now being shown in a closed condition and housed within a grommet that forms a part of the integrated fastener assembly; 
           [0062]      FIGS. 36 and 37  are side views showing the use of the intraluminal tool shown in  FIG. 33  to apply force to drive the fastener from its position shown in  FIG. 35  and through the vessel wall; 
           [0063]      FIG. 38  is the integrated fastener assembly after deployment to anchor a prosthesis to a vessel wall; 
           [0064]      FIG. 39  is a side view showing the use of a tracking wire to guide a intraluminal tool into contact with a fastener, so that force can be applied to drive the fastener through the vessel wall; 
           [0065]      FIG. 40  is an embodiment of a prosthesis delivery catheter for a prostheses in which the stent structure covers only a portion of the prosthesis, the catheter including an array of stabilization struts to help hold the prosthesis in position against the flow of blood; 
           [0066]      FIG. 41  is another embodiment of a prosthesis delivery catheter for a prostheses in which the stent structure covers only a portion of the prosthesis, the catheter including an array of inverted stabilization struts to help hold the prosthesis in position against the flow of blood; and 
           [0067]      FIG. 42  is another embodiment of a prosthesis delivery catheter for a prostheses in which the stent structure covers only a portion of the prosthesis, the catheter including a stabilization basket to help hold the prosthesis in position against the flow of blood. 
           [0068]      FIG. 43  is an elevation view of an alternative stabilization device, comprising tissue gripping elements. 
           [0069]      FIGS. 44A and 44B  are elevation views of a fastener applier that carries an expandable basket-like structure that serves as a stabilization device,  FIG. 44A  showing the basket-like structure in a generally collapsed condition for intravascular deployment and  FIG. 44B  showing the basket-like structure in an expanded condition against a vessel wall and graft for deployment of a fastener. 
           [0070]      FIG. 45  shows, in diagrammatic fashion, the resolution of an implantation force with a counteracting force within a vessel or hollow body organ. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     I. Delivering a Prosthesis 
       [0071]      FIG. 1  depicts an endovascular graft delivery catheter  10  as it is being positioned over a guidewire  12  in a body lumen. The catheter  10  carries a prosthesis  14  (see  FIG. 2 ), which is placed at a targeted site, e.g., by radial expansion of the prosthesis  14  (see  FIG. 3 ). After partial or complete expansion of the prosthesis  14 , one or more fasteners  28  (see  FIGS. 15 and 16 ) are introduced by a fastener attachment assembly (as will be described in greater detail later) to anchor the prosthesis  14  in place. 
         [0072]    For the purposes of illustration,  FIG. 1  shows the targeted site as being within an abdominal aortic aneurysm  11 . The targeted site can be elsewhere in the body. In the illustrated arrangement, the prosthesis  14  takes the form of an endovascular graft. 
         [0073]      FIG. 2  depicts the initial stage of graft deployment at the targeted site. While the deployment method can vary, in the illustrated embodiment, the delivery catheter  10  has a movable cover  13 , which overlays the graft  14 . When the cover  13  is pulled proximally, the graft  14  is free to radially expand, thereby enlarging to contact the internal walls of the blood vessel. The graft  14  is shown to be self-expanding. Alternatively, the graft  14  can utilize an expanding member, such as a balloon or mechanical expander. 
         [0074]    The process of graft deployment is continued, until the graft  14  is fully deployed or partially deployed within the vessel. The graft  14  can be sized and configured to be either straight or bifurcated form.  FIG. 3  depicts a completely deployed straight graft  14 .  FIG. 4  depicts a completely deployed bifurcated graft  15 . 
         [0075]    A. The Prosthesis 
         [0076]    The graft  14  desirably incorporates a support frame or scaffold  16 . The scaffold  16  may be elastic, e.g., comprised of a shape memory alloy elastic stainless steel, or the like. For elastic scaffolds, expanding typically comprises releasing the scaffolding from a constraint to permit the scaffold to self-expand at the implantation site. In the illustrated arrangement, the cover  13  serves as a radial constraint. Alternatively, placement of a tubular catheter, delivery sheath, or the like over the scaffold  16  can serve to maintain the scaffold in a radially reduced configuration. In this arrangement, self-expansion of the scaffold  16  is achieved by pulling back on the radial constraining member, to permit the scaffold  16  to assume its larger diameter configuration. 
         [0077]    Alternatively, the scaffold  16  may be constrained in an axially elongated configuration, e.g., by attaching either end of the scaffold to an internal tube, rod, catheter or the like. This maintains the scaffold  16  in the elongated, reduced diameter configuration. The scaffold  16  may then be released from such axial constraint in order to permit self-expansion. 
         [0078]    Alternatively, the scaffold  16  may be formed from a malleable material, such as malleable stainless steel of other metals. Expansion may then comprise applying a radially expansive force within the scaffold to cause expansion, e.g., inflating a scaffold delivery catheter within the scaffold in order to affect the expansion. In this arrangement, the positioning and deployment of the endograft can be accomplished by the use of an expansion means either separate or incorporated into the deployment catheter. This will allow the endograft to be positioned within the vessel and partially deployed while checking relative position within the vessel. The expansion can be accomplished either via a balloon or mechanical expansion device. Additionally, this expansion stabilizes the position of the endograft within the artery by resisting the force of blood on the endograft until the endograft can be fully deployed. 
         [0079]    The graft  14  may have a wide variety of conventional configurations. It can typically comprise a fabric or some other blood semi-impermeable flexible barrier which is supported by the scaffold  16 , which can take the form of a stent structure. The stent structure can have any conventional stent configuration, such as zigzag, serpentine, expanding diamond, or combinations thereof. The stent structure may extend the entire length of the graft, and in some instances can be longer than the fabric components of the graft. Alternatively, the stent structure can cover only a small portion of the prosthesis, e.g., being present at the ends. The stent structure may have three or more ends when it is configured to treat bifurcated vascular regions, such as the treatment of abdominal aortic aneurysms, when the stent graft extends into the iliac arteries. In certain instances, the stent structures can be spaced apart along the entire length, or at least a major portion of the entire length, of the stent-graft, where individual stent structures are not connected to each other directly, but rather connected to the fabric or other flexible component of the graft. 
         [0080]    One illustrative embodiment of the graft scaffold  16  or stent structure is illustrated in the area broke away in  FIG. 4 . Here, the stent structure is in the form of a simple zigzag pattern, however it is contemplated that the stent design could involve more complex patterns  17  as depicted in  FIG. 5 . Although only one stent structure within the graft is depicted, in  FIGS. 4 and 5 , it is contemplated that multiple independent stent structures could be incorporated into the graft, as previously described. 
         [0081]      FIG. 40  shows an embodiment of a prosthesis delivery catheter  600  for a prostheses  14  in which the stent structure  16  covers only a portion of the prosthesis, e.g., being present only at the ends. As shown in  FIG. 40 , the prosthesis delivery catheter  600  (which is shown deployed over a guidewire  610 ) includes an array of stabilization struts  612  that are releasably coupled to the stent structure  16  at the end of the prosthesis  14 , e.g., by sutures that can be released by pulling on a drawstring (not shown) that passes through a lumen in the catheter  600 . The stabilization struts  612  hold the self-expanding stent structure  16  in position against the vessel wall  34 , while the remainder of the prosthesis  14  is being deployed (by withdrawal of a delivery sheath  614 ). The struts  612  support the stent structure  16  (and thus the overall prosthesis  14 ) against the force of blood flow through the vessel during prosthesis deployment. The catheter  600  can also include a nose cone  618  at its distal end to diffuse blood flow toward the vessel wall, to aid in supporting the prosthesis  14  during its deployment. Upon deployment of the prosthesis  14 , the struts  612  can be detached from the stent structure  14  by pulling upon the drawstring to release the sutures, and the catheter  600  is withdrawn over the guidewire  610  through the delivery sheath  614  (the struts  612 , freed from the stent structure  16 , fold back upon the catheter  600  during passage through the delivery sheath  614 ). 
         [0082]      FIG. 41  shows an alternative embodiment of a prosthesis delivery catheter  700  for a prostheses  14  in which the stent structure  16  covers only a portion of the prosthesis, e.g., being present at the ends. As shown in  FIG. 40 , the prosthesis delivery catheter  700  (which is also shown deployed over a guidewire  710 ) includes an array of inverted stabilization struts  712  that are releasably coupled to the stent structure  16  at the end of the prosthesis  14 , e.g., by sutures that can be released by pulling on a drawstring (not shown) that passes through a lumen in the catheter  700 . The inverted stabilization struts  712 , like the struts  612  shown in  FIG. 40 , hold the self-expanding stent structure  16  in position against the vessel wall  34 , while the remainder of the prosthesis  14  is being deployed (by withdrawal of a delivery sheath  714 ). Like the catheter  600  in  FIG. 40 , the catheter  700  can also include a nose cone  718  at its distal end to diffuse blood flow toward the vessel wall. Upon deployment of the prosthesis  14 , the struts  712  are detached from the stent structure  14  by pulling upon the drawstring not shown), and the catheter  700  is withdrawn over the guidewire  710  through the delivery sheath  714  (the struts  612 , freed from the stent structure  16 , fold back upon the catheter  600  during passage through the delivery sheath  614 ). 
         [0083]      FIG. 42  shows another alternative embodiment of a prosthesis delivery catheter  800  for a prostheses  14  in which the stent structure  16  covers only a portion of the prosthesis, e.g., being present at the ends. As shown in  FIG. 42 , the prosthesis delivery catheter  800  (which is also shown deployed over a guidewire  810 ) includes a self-expanding stabilization basket  812 . The stabilization basket  812  holds the self-expanding stent structure  16  in position against the vessel wall, while the remainder of the prosthesis  14  is being deployed (by withdrawal of a delivery sheath  814 ). Like the catheters  600  and  700  in  FIGS. 40 and 41 , the catheter  800  can also include a nose cone  818  at its distal end to diffuse blood flow toward the vessel wall. Upon complete deployment of the prosthesis  14 , the stabilization basket can be placed into a collapsed condition by withdrawal through the delivery sheath  814 , as the catheter  800  is withdrawn over the guidewire  810 . 
         [0084]    In all of the just-described embodiments, if the prosthesis  14  has been fully deployed prior to the introduction of the fasteners  28 , and/or the prosthesis delivery catheter  600 ,  700 , or  800  has been withdrawn from the targeted site, the guidewire  610 ,  710 ,  810  can be subsequently used to deploy a fastener attachment assembly for the prosthesis  14  to the targeted site, as will be described in greater detail next. Alternatively, if the prosthesis  14  has not been fully deployed at the time the fasteners  28  are applied—or if, for whatever reason, withdrawal of the prosthesis delivery catheter  600 ,  700 , or  800  is not desired—the prosthesis delivery catheter  600 ,  700 , or  800 , and its respective guidewire  610 ,  710 , or  810 , can be retained at the targeted site, while a fastener attachment assembly for the prosthesis  14  is introduced into the targeted site over a separate guidewire from another body access point. In this arrangement, deployment of the prosthesis  14  and/or withdrawal of the prosthesis delivery catheter  600 ,  700 , or  800  can be completed after the fasteners  28  have been applied. 
       II. Fastening the Prosthesis 
       [0085]    In a desired embodiment, a fastener attachment assembly is provided that makes possible intraluminal fastener attachment. The attachment assembly can be variously constructed. 
         [0086]    A. Two Component Fastener Guide and Attachment Assembly 
         [0087]    In one arrangement, the fastener attachment assembly comprises a fastener guide or directing component  18  and a fastener applier component  27 . The guide component  18  desirably has a steerable or deflectable distal tip, which is initially deployed over the guidewire  12 . In use in the illustrated embodiment, the guidewire  12  that is used to deliver and position the prosthesis  14  remains within the vessel for subsequent deployment of the fastener guide component  18 . Alternatively, another guidewire from a different body access point can be used for deployment of the fastener guide component  18 . In either arrangement, the fastener applier component  27  is desirably deployed through the guide component  18  after removal of the guidewire over which the guide component  18  has been delivered. The fastener applier  27  carries at least one fastener  28  and a fastener drive mechanism  100  for advancing the fastener  28 , so that it penetrates the prosthesis  14  and underlying vessel wall, to thereby anchor the prosthesis  14  firmly in place. 
         [0088]    1. Fastener Directing Component 
         [0089]      FIG. 6  depicts one embodiment of the directing or guide component  18  that forms a part of the fastener attachment assembly. The component  18  includes an interior lumen that accommodates passage of an obturator  19 . The obturator  19  has a lumen to allow for delivery of the directing component  18  over the guidewire  12 , as shown in  FIG. 7 . Once deployed in a desired location, the obturator  19  and guidewire  12  are removed, leaving the central lumen open for passage of the fastener applier component  27 , as will be described later. 
         [0090]    In the illustrated embodiment (see  FIG. 8 ), the directing component  18  includes a control assembly  21 . In one embodiment the control assembly  21  features a movable wheel or lever  22 , which operate interior steering wires in a conventional fashion to deflect the distal tip  23  of the directing component  18  toward a desired location, as seen in  FIG. 9 . It is contemplated that the control assembly  21  for the directing component  18  could be activated mechanically, electrically, hydraulically or pneumatically. The control assembly  21  has a through lumen to allow for the passage of the obturator  19  (as just described) and the fastener applier component  27 , as will be described next. 
         [0091]    2. Fastener Applier Component 
         [0092]      FIG. 14  shows one embodiment of the fastener applier component  27  that forms a part of the fastener attachment assembly. As  FIG. 15  depicts, the fastener applier component  27  is deployed through the central lumen of the directing component  18  to the site where a fastener  28  will be installed. 
         [0093]    Located at the distal end of the fastener applier component  27  (see  FIG. 14 ) is a fastener drive mechanism  100 . In the illustrated embodiment (see  FIG. 14A ), the drive mechanism  100  includes a driver  29  that is coupled to a carrier  102 . The coupling between the driver  29  and carrier  102  can take different forms—e.g., magnets, graspers, or other suitable mechanical connection. In the embodiment illustrated in  FIG. 14A , the driver  29  and carrier  102  are integrally connected as a single unit. 
         [0094]    The carrier  102  is sized and configured to engage a selected fastener  28 . In  FIG. 14A , the fastener takes the form of a helical fastener of the type shown in  FIGS. 18 and 27 . As best shown in  FIG. 27 , and as will be described in greater detail later, the helical fastener  28  in  FIG. 26  is an open coil  148  with a sharpened leading tip  142 . The proximal end  144  of the fastener  28  includes an L-shaped leg  146 . The L-shape leg  146  desirably bisects the entire interior diameter of the coil  148 ; that is, the L-shaped leg  146  extends completely across the interior diameter of the coil  148 , as  FIG. 27  shows. The L-shaped leg  146  serves to engage the carrier  102  of the fastener applier  27 , which rotates the helical fastener to achieve implantation. The L-shaped leg  146  also serves as a stop to prevent the helical fastener from penetrating too far into the tissue. 
         [0095]    The carrier  102  in  FIG. 14A  includes a slot  180 , which receives the L-shaped leg  146  to couple the fastener  28  for rotation with the carrier  102 . The turns of the coil  148  rest in complementary internal grooves  32  that surround the carrier  102 . The grooves  32  could be positioned along the entire length of the fastener  28  or within a portion of its length. 
         [0096]    The actuation of the drive mechanism  100  can, of course, be accomplished in various ways, e.g., mechanical (i.e., manual or hand-powered), electrical, hydraulic, or pneumatic. In the illustrated embodiment (see  FIG. 14B ), a drive cable  30  couples the fastener driver  29  to an electric motor  106  carried in the applier handle  108 . The drive cable  30  is desirably made of a suitable material that allows for both bending and rotation. Driven by the motor  106  (which is, in turn, under the control of motor control unit  31 , as will be described later), the drive cable  30  rotates the driver  29  and, with it, the carrier  102 . The carrier  102  imparts rotation and torque to the helical fastener  28  for implantation in tissue. 
         [0097]      FIG. 16  is an enlarged cross-sectional view of fastener applier  27  and directing device  18 .  FIG. 17  is an enlarged cross-sectional view of the fastener applier  27  with a cross-section of the fastener driver  29  depicting the engagement between the fastener driver  29  and helical fastener  28 .  FIG. 19  depicts the fastener applier  27  during activation of the fastener drive mechanism  100 . Activation of the drive mechanism  100  rotates, as a unit, the drive shaft  30 , the driver  29 , the carrier  102 , and helical fastener  28 . This rotation causes the helical fastener  28  to travel within the internal grooves  32  of the fastener applier and into the prosthesis  14  and vessel wall  34  (see  FIG. 20 ).  FIG. 21  illustrates a completed helical fastener  28  attachment of the graft  14  to the vessel wall  34 . 
         [0098]    In use, the applier component  27  is advanced through the directing component  18  and into contact with the prosthesis. The operator actuates the control unit  31  by contacting a control switch  110  (see  FIGS. 14 and 14B ). This action causes the helical fastener  28  to be rotated off the carrier  102  and through the prosthesis  14  and into the vessel wall  34 . The motor control unit  31  desirably rotates the drive cable  30  a specific number of revolutions with each activation command. This can be accomplished by incorporating a mechanical or electrical counter. 
         [0099]    With the deployment of a fastener  28 , the fastener applier component  27  is retrieved through the directing component  18 , and another fastener  28  is loaded into the carrier  102 . The directing component  18  is repositioned, and the applier component  27  is advanced again through the directing component  18  and into contact with the prosthesis  14 . The operator again actuates the control unit  31  by contacting the control switch  110  to deploy another fastener  28 . This process is repeated at both proximal and/or distal ends of the prosthesis  14  until the prosthesis  14  is suitably attached and sealed to the vessel wall  34 . It is contemplated that from about two to about twelve fasteners  28  may be applied at each end of the prosthesis  14  to affect anchorage. The fasteners  28  can be applied in a single circumferentially space-apart row, or may be applied in more than one row with individual fasteners being axially aligned or circumferentially staggered. 
         [0100]      FIG. 22  illustrates a perspective view of a graft prosthesis attached to the vessel wall both proximally and distally. It is contemplated that the present invention can be used for graft attachment of both straight and bifurcated grafts within the aorta and other branch vessels. 
         [0101]    An alternative embodiment of the drive mechanism  100  is shown in  FIGS. 25A and 25B . In this embodiment, the driver  29  is coupled to a carrier  150 , which forms a part of the helical fastener  28  itself, as also shown in  FIG. 28A . As shown in  FIG. 28A , the helical fastener  28  is, like the fastener shown in  FIG. 27 , an open coil  148  with a sharpened leading tip  142 . The proximal end  144  of the fastener  28  includes the carrier  150 . 
         [0102]    The carrier  150  includes a slot  182 . The slot  182  engages a drive flange  184  on the driver  29  (see  FIG. 25A ) to impart rotation of the driver  29  to rotation of the helical fastener  28  during the implantation process. Like the L-shaped leg of the fastener shown in  FIG. 27 , the carrier  150  also serves as a stop to prevent the helical fastener from penetrating too far into the tissue. 
         [0103]    The coupling engagement between the carrier  150  and the driver  29  could be accomplished in various ways, e.g., by separate graspers or grippers, a magnetic couple, or any other suitable mechanical connecting means. In the illustrated embodiment, the driver  29  is made of a magnetized material, and the carrier  150  is made from a material that is magnetically attracted toward the magnetized material. Of course, a reverse arrangement of magnetized and magnetically attracted materials could be used. 
         [0104]    In this arrangement, the motor coupling  132  between the drive cable  30  and the motor  106  accommodates axial displacement of the motor cable  30  (left and right in  FIGS. 25A and 25B ) without interrupting the drive connection with the motor  106 . With the distal tip of the applier device  27  in contact with the prosthesis  14  (see  FIG. 25A ), the operator actuates the control unit  31  by contacting a control switch  110 . The control unit  31  commands the motor  106  to rotate the drive cable  30  to impart rotation to the driver  29  and the magnetically attached helical fastener  28 . This action causes the magnetically attached helical fastener  28  to be rotated into prosthesis  14  and the vessel wall  34  (see  FIG. 25B ). Due to the magnetic coupling, as the fastener  28  is deployed to the left in  FIG. 25B , the driver  29  moves in tandem with carrier  150  (also to the left in  FIG. 25B ). Due to the magnetic coupling between the carrier  150  and the driver  29 , the operator must exert a deliberate separation force to decouple the carrier  150  (and, with it, the fastener  28 ) from the driver  29 . This arrangement prevents inadvertent release of a fastener  28 . 
         [0105]    As before described, with the deployment of a fastener  28 , the applier component  27  is retrieved through the directing device  18 , and another fastener  28  is magnetically coupled to the driver  29 . The directing component  18  is repositioned, and the applier component  27  is advanced again through the directing component  18  and into contact with the prosthesis  14 . The operator again actuates the control unit  31  by contacting a control switch  110  to deploy another fastener  28 . This process is repeated at both proximal and/or distal ends of the prosthesis  14  until the prosthesis  14  is suitably attached and sealed to the vessel wall  34 . 
         [0106]    As indicated in the above description, the outer diameter of the applier component  27  is desirably sized and configured to pass through the lumen of the directing component  18 , which can take the form of a suitable steerable guide catheter, to direct the applier component  27  to the desired location. As also above described, the applier component  27  is desirably configured to implant one fastener  28  at a time (a so-called “single fire” approach). This is believed desirable, because it reduces the complexity of the design and accommodates access of the applier component  27  through tortuous anatomy. A fastener applier component  27  which carries a single fastener can have a lower profile and may be more effective and less traumatic than fastener appliers which carry multiple fasteners. Still, in alternative embodiments, the applier component  27  may, if desired, be configured to carry multiple fasteners. Moreover, the fastener applier  27  may simultaneously deploy multiple fasteners in the preferred circumferentially spaced-apart space pattern described above. 
         [0107]    3. Force Resolution 
         [0108]    Penetration and implantation of the fastener  28  into tissue using the applier component  27  requires the applier component  27  to exert an implantation force at or near the prosthesis  14  and vessel wall  34 . In the illustrated embodiment, the applier component  27  comprises a driven member for implanting a helical fastener. However, the applier component  27  can comprise virtually any actuated member for exerting an implantation force using, e.g., ultrasonic, laser, or impact concepts. 
         [0109]    Regardless of the particular way that the implantation force is generated, the implantation force of the applier component  27  is desirably resolved in some manner to provide positional stability and resist unintended movement of the applier component  27  relative to the implantation site. Stated differently, a resolution force is desirably applied to counteract and/or oppose the implantation force of the applier component  27 . It is desirable to resolve some or all or a substantial portion of the implantation force within the vessel lumen (or other hollow body organ) itself, and preferably as close to the implantation site as possible. 
         [0110]    The tubular body of the directing component  18  and/or the shaft of the fastener applier component  27  can be sized and configured to possess sufficient column strength to resolve some or all or at least a portion of the implantation force within the vessel lumen or hollow body organ. In addition, or alternatively, the directing component  18  and/or the fastener applier component  27  can include stabilization means  20  for applying a counteracting force at or near the driven member of the fastener applier component  27  that implants the fastener. 
         [0111]    The illustrated embodiments show various alternative embodiments for the stabilization means  20 . As shown in  FIGS. 8 and 9 , the stabilization means  20  takes the form of a spring-loaded arm on the directing component  18  for contacting tissue. In this arrangement, the spring-loaded stabilizing means  20  is positioned for deployment when the obturator  19  and guidewire  12  are removed from the directing component  18  (see  FIG. 8 ). In the alternative embodiment shown in  FIGS. 10 and 11 , the stabilization means  20  takes the form of a movable strut assembly  24  on the directing component  18 , which contacts tissue. In this alternative arrangement, the movable strut assembly  24  can be activated, e.g., through a lever  25  on the control assembly (see  FIG. 11 ). In both embodiments ( FIGS. 7 and 10 ) the stabilizing device  20  is distal to the end of the directing component  18 . In the alternative embodiment shown in  FIG. 12 , the stabilization means  20  takes the form of an expandable member  26  positioned adjacent the distal tip of the directing component  18 . In this alternative arrangement (see  FIG. 13 ), the expandable member  26  can be activated, e.g., through a lever  25  on the control assembly  21 . However it also contemplated that this type of stabilizing means  20  could also be inflatable. In another alternative embodiment (see  FIG. 43 ), the stabilization means  20  includes means  200  carried by the directing component  18  and/or the fastener applier component  27  for grasping and/or anchor to the wall of the hollow body organ, vessel or prosthesis prior to implanting a fastener. The grasping or anchoring means  200  can include penetrating needles and/or hooks or barbs that are deployed by a control assembly or the like prior to implantation of a fastener. 
         [0112]    In all embodiments the stabilizing means  20  could be use to stabilize the directing component  18  either concentrically or eccentrically within the vessel. 
         [0113]    Of course, any of these alternative forms of the stabilization means  20  can be associated with the fastener applier  27  in the same fashion they are shown to be associated with the directing component  18 , or take some other form of a stabilization mechanism having the equivalent function. In yet another embodiment, the stabilization means  20  can take the form of a separate stabilization device used in cooperation with the directing component  18  and/or the fastener applier component  27 . In this arrangement, the separate stabilization device could incorporate any of the alternative forms of the stabilizing devices described above, or some other form of stabilization mechanism. 
         [0114]    For example (see  FIGS. 44A and 44B ), the fastener applier  27  can carry about its distal end an expandable basket  202  or basket-like structure. The basket structure  202  surrounds the fastener drive mechanism  100 , which has been previously described. The basket structure  202  is operable between a low profile, generally collapsed condition (shown in  FIG. 44A ) and an expanded profile condition (shown in  FIG. 44B ) about the fastener drive mechanism  100 . 
         [0115]    In the generally collapsed condition, the fastener applier  27  can be deployed through a vessel into proximity to a graft  14 .  FIG. 44A  shows the graft  14  to include a self-expanding scaffold  16 . When in the generally collapsed condition, the fastener applier  27  can be deployed in its low profile state through the vasculature to the targeted graft site either by itself, or through an associated directing component  18  or suitable guide sheath, which can steerable or non-steerable. 
         [0116]    When situated at the graft site (see  FIG. 44B ), the basket structure  202  can be expanded (e.g., by a suitable push-pull control mechanism) into contact with the graft  14 . The fastener applier  27  can be maneuvered within the expanded basket structure  202  into contact with the graft  14  and operated to deploy a fastener  28 , as previously described. The basket structure  202  serves to resolve at least some of the implantation force to provide positional stability and resist unintended movement of the fastener applier  27 . 
         [0117]    In all these alternative embodiments, the stabilization means  20  functions to apply a substantially equal and opposite counteracting resolution force within a vessel (see  FIG. 45 ) to a location on the vessel wall, desirably generally opposite to the implantation site. As also just described, the column strength of the associated directing component  18  and/or fastener applier  27  can also serve in conjunction with the stabilization means  20  to resolve the intraluminal implantation force at the implantation site. 
         [0118]    The force resolving function that the guiding component  18  and/or the fastener applier component  27  provide serves to counteract or oppose or otherwise resolve the tissue penetration and implantation force of the applier component  27 . The force resolving function thereby also resists movement of the applier component  27  relative to the implantation site, thereby making possible a stable and dependable intraluminal (or intra organ) fastening platform. 
         [0119]    4. Prosthesis/Tissue Contact Sensing 
         [0120]    The fastener applier component  27  desirably incorporates a function that prevents actuation of the motor  106  until the tip of the applier component  27  is in a desired degree of contact with the prosthesis or tissue surface. This prevents inadvertent discharge of a fastener  28  and/or separation of the fastener  28 . This function can be implemented, e.g., using a contact or force sensor, which is either mechanical or electrical in design. 
         [0121]    When the fastener applier component  27  is of the type shown in  FIGS. 14A. 14B , and  14 C (see  FIGS. 23 and 24 ), the contact or force sensing function can, e.g., utilize the distal tip  120  of the carrier  102  to transmit a contact force. This force can be transmitted to a force or contact sensing switch  122  located, e.g., within the fastener applier handle  108 . In this arrangement, the switch  122  can be part of the electrical circuit between the actuator switch  110  and the control unit  31 . 
         [0122]    In the illustrated embodiment, the switch  122  includes a stationary switch element  128  (coupled to the interior of the handle  108 ) and a movable switch element  130  (carried by the drive cable  31 ). In this arrangement, the motor coupling  132  between the drive cable  30  and the motor  106  accommodates axial displacement of the motor cable  30  (left and right in  FIGS. 23 and 24 ) without interrupting the drive connection with the motor  106 . The drive cable  30  is coupled by a bearing  134  to the movable switch element  130 , so that the switch element  130  moves in response to movement of the drive cable  30 . The stationary switch element  128  is not coupled to the movable drive cable  30 , which slidably passes through the switch element  130 . 
         [0123]    Due to this arrangement, axial displacement of the drive cable  30  moves the switch element  130  relative to the switch element  128 . More particularly, displacement of the drive cable  30  to the left in  FIG. 23  moves the switch element  130  to the left, away from the switch element  128 . Conversely, displacement of the drive cable  30  to the right in  FIG. 23  moves the switch element  130  to the right, toward the switch element  128 . 
         [0124]    A spring  126  normally biases the switch elements  128  and  130  apart, comprising an electrically opened condition. In this condition, operation of the actuating switch  110  does not serve to actuate the control unit  31 , as the electrically open switch  122  interrupts conveyance of the actuation signal to the motor control unit  31 . When the switch elements  128  and  130  are in the electrically opened condition, the drive cable  30  is displaced to the left to position the carrier tip  120  beyond the distal tip  124  of the fastener applier  27 . The carrier tip  120  therefore makes contact with the prosthesis  14  or tissue in advance of the applier tip  124 . 
         [0125]    When the carrier tip  120  contacts the surface of the prosthesis or tissue with sufficient force to compress the spring  126 , the drive cable  30  is displaced against the biasing force of the spring to the right in  FIG. 23 . This moves the switch element  130  to the right. Ultimately, contact between the switch elements  128  and  130  will occur, as shown in  FIG. 24 . The contact establishes an electrically closed, condition. In this condition, operation of the actuating switch  110  serves to actuate the control unit  31 . As shown in  FIGS. 23 and 24 , a contact screw  136  can be provided to adjust the amount of displacement required to close the switch elements  128  and  130 . 
         [0126]    Upon removal of contact force, or in the absence of sufficient contact force, the spring  126  urges the switch elements  128  and  130  toward the electrically opened condition. The distal tip of the carrier  102  is located distally beyond the distal tip of the applier  27 . 
         [0127]    It should be appreciated that the translation of movement of the carrier tip  120  to the switch  122  need not occur along the entire length of the drive cable  30 . For example, the switch  122  can be located in a translation space between the carrier  102  and the driver  29 . In this arrangement, the driver  29 , coupled to the drive cable  30  need not accommodate axial displacement. Instead, relative movement of the carrier  102  toward the driver  29  in response to contact with the prosthesis  14  will mechanically couple the carrier  10  with the driver  29  (e.g., through a slot and flange connection similar to that shown in  FIGS. 25A and 25B ), while also closing the switch  122  to energize the circuit between the actuator switch  110  and the motor control unit  31 . 
         [0128]    When the fastener applier component  27  is of the type shown in  FIGS. 25A and 25B  (see  FIGS. 26A ,  26 B, and  26 C), the contact or force sensing function can, e.g., utilize a force sensing rod  190  that slidably passes through a central passage  192  in the carrier  150 ′ (the carrier  150 ′ is shown in  FIG. 28B ), the driver  29  and the drive cable  30 . The rod  190  is coupled to the movable switch element  130 . In this embodiment, the switch element  130  translates left and right over the drive cable  30 , which rotates on a bearing  134  within the switch element  130 . 
         [0129]    As in the preceding embodiment, the spring  126  normally biases the switch elements  128  and  130  apart, comprising an electrically opened condition. When the switch elements  128  and  130  are in the electrically opened condition, the force sensing rod  190  is displaced to the left beyond the distal tip  124  of the fastener applier component  27 . The force sensing rod  190  therefore makes contact with the prosthesis  14  or scaffold structure  16  in advance of the applier tip  124 . 
         [0130]    When the rod  190  contacts the surface of the prosthesis or scaffold structure with sufficient force to compress the spring  126 , the rod  190  is displaced against the biasing force of the spring  126  to the right in  FIG. 26A . This moves the switch element  130  to the right. Ultimately, contact between the switch elements  128  and  130  will occur, as shown in  FIG. 26B . The contact establishes an electrically closed condition. In this condition, operation of the actuating switch  110  serves to actuate the control unit  31 . This action causes the helical fastener  28  to be rotated into the scaffold structure  16  and into the vessel wall  34  (see  FIG. 26C ). Due to the magnetic coupling between the driver  29  and carrier  150 ′, the driver  29  is moved in tandem with attached carrier  150 ′ to the left in  FIG. 26B , as the fastener  28  is deployed. Also, due to the magnetic coupling between the carrier  150  and the driver  29 , the operator must exert a separation force to decouple the carrier  150  (and, with it, the fastener  28 ) from the driver  29 . As before described, this arrangement prevents inadvertent release of a fastener  28 . A contact screw  136  can be provided to adjust the amount of displacement required to close the switch elements  128  and  130 . 
         [0131]    Upon removal of contact force, or in the absence of sufficient contact force, the spring  126  urges the switch elements  128  and  130  toward the electrically opened condition, moving the tip of the rod  190  out beyond the distal tip  124  of the applier  27 . 
         [0132]    The contact or force sensing arrangements just described can also generate an audible and/or visual output to the operator, to indicate that sufficient contact force between the applier device  27  and the prosthesis or tissue exists. 
         [0133]    B. Angled Component Fastener Guide and Attachment Assembly 
         [0134]    In another arrangement (see  FIG. 29 ), the fastener attachment assembly comprises a unitary, angled fastener guide and applier component  160 . In this arrangement, the component  160  includes a fastener drive mechanism  162  that places the carrier  164  holding the fastener  28  in a perpendicular or near perpendicular position with respect to the prosthesis or tissue. This configuration eliminates the need for a separate steerable guide component  18  for the fastener component  27 , previously described. 
         [0135]    The drive mechanism  162  can vary. In the illustrated embodiment (shown in  FIG. 29 ), the mechanism  162  includes a beveled drive gear  168  coupled to the drive cable  30 . The drive gear  168  operatively meshes with a transfer or pinion gear  170 , which is coupled to the carrier  164 . The axes of rotation of the drive gear  168  and pinion gear  170  are offset about ninety degrees, so that rotation of the drive cable  30  along the axis of the vessel is translated into rotation of the carrier  164  generally perpendicular to the wall of the vessel. The fastener guide and applier component  160  can be positioned and stabilized within the vessel in various ways, e.g., through the use external spring loaded strut or the like (as shown in association with the directing component  18  discussed above), or by use of an expandable member  166  (as  FIG. 29  shows). The expansion member  166  can comprise either a balloon or mechanical expansion device. The expansion member  166  stabilizes the position of both the prosthesis and the fastener guide and applier component  160  within the vessel by resisting the force of blood until the prosthesis can be anchored. 
         [0136]    As  FIG. 30  shows, the fastener guide and applier component  160  can, if desired, provide an angled deployment between the drive cable  30  and carrier  164  that is somewhat less than ninety-degrees, to aid in intraluminal manipulation of the carrier into perpendicular contact position against the wall of the vessel. As  FIG. 31  shows, the fastener guide and applier component  160  can, if desired, be articulated between the drive cable  30  and carrier  164 . In this arrangement, a remote control mechanism is desirable provided to move the carrier  164  from a first, generally straight position (shown in phantom lines in  FIG. 31 ) for deployment to the targeted site, to a second, articulated position (shown in solid lines in  FIG. 31 ) for alignment of the carrier  164  in contact against the vessel wall. 
       III. The Fasteners 
       [0137]    As illustrated and described thus far, introduction of the fasteners  28  will typically be affected after the prosthesis  14  has been initially placed. That is, initial placement of the prosthesis  14  will be achieved by self-expansion or balloon expansion, after which the prosthesis  14  is secured or anchored in place by the introduction of a plurality of individual fasteners. The fasteners  28  may be placed only through the fabric of the prosthesis  14 , i.e., avoiding the scaffold structure. Alternately, the fasteners  28  can be introduced into and through portions of the scaffold structure itself. The prosthesis  14  may include preformed receptacles, apertures, or grommets, which are specially configured to receive the fasteners. The fasteners  28  may be introduced both through the fabric and through the scaffold structure. The fasteners can be introduced singly, i.e., one at a time, in a circumferentially spaced-apart pattern over an interior wall of the prosthesis  14 . 
         [0138]    In the exemplary embodiment, the fasteners  28  are helical fasteners, so that they can be rotated and “screwed into” the prosthesis  14  and vessel wall. A desired configuration for the helical fastener  28  (see  FIGS. 27 ,  28 A, and  28 B) is an open coil  148 , much like a coil spring. This configuration allows the fastener  28  to capture a large area of tissue, which results in significantly greater holding force than conventional staples, without applying tissue compression, which can lead to tissue necrosis. 
         [0139]    As  FIGS. 27 ,  28 A, and  28 B show, the leading tip  142  of the helical fastener  28  is desirable sharp to allow it to penetrate thought the artery wall and/or calcified tissue. This distal tip  142  can be sharpened to cut a helical path through the tissue or it can be sharpened to a point to penetrate the tissue without cutting. 
         [0140]    The proximal end  144  of the fastener serves two design functions. The first function is to engage the carrier  102  of the fastener applier  27 , which rotates the helical fastener during the implantation process. The second function is to act as a stop to prevent the helical fastener from penetrating too far into the tissue. 
         [0141]    In one embodiment (see  FIG. 27 ), the proximal end  144  of the helical fastener  28  includes an L-shaped leg  146  of the coil  148  bisecting the fastener diameter. The leg  146  of the coil  148  comes completely across the diameter to prevent the fastener from being an open coil and to control the depth of penetration into the tissue. In addition, the leg  146  of the coil  148  can be attached to a previous coil to strengthen the entire structure and provide a more stable drive attachment point for the fastener applier. This attachment could be achieved via welding, adhesive or any other suitable means. 
         [0142]    Alternatively (as shown in  FIGS. 28A and 28B ), the proximal end  144  of the fastener  28  could incorporate a separate cap or carrier  150  or  150 ′ that serves the same function as the leg  146  of the coil  148  in  FIG. 27 . The carrier  150  or  150 ′ could feature several methods to attach to the fastener applier drive mechanism  100 . These include separate graspers or grippers, a magnetic couple (as previously described), or any other suitable mechanical connecting means. In  FIGS. 28A and 28B , the carrier  150  and  150 ′ includes a slot  180  and  182 ′ to mate with a drive flange (as previously described). As also previously described, a magnetic coupling is implemented between the carrier  150  and  150 ′ and the corresponding drive member, to prevent inadvertent separation during use. 
         [0143]    In  FIG. 28B , the carrier  150 ′ also includes a passage  152  for holding the contact/force sensing rod  190  shown in  FIGS. 26A ,  26 B, and  26 C. 
         [0144]    The fasteners  28  shown in  FIGS. 27 ,  28 A, and  28 B can be made from stainless steel or other types of implantable metal, however it is also envisioned that the fasteners in the above descriptions could be made from implantable polymers or from a biodegradable polymer or combinations of all materials thereof. Desirably, a fastener  28  will have between 2 and 10 turns and will be between 1 mm and 10 mm long. The space between the individual coils will be between 0.25 mm and 3 mm. The diameter of the fastener  28  will be between 1 mm and 6 mm. 
         [0000]    IV. Prosthesis with Integrated Fastener Assembly 
         [0145]      FIG. 32  shows a prosthesis  500  that includes at least one integrated fastener assembly  502 .  FIG. 32  shows the prosthesis  500  deployed in a targeted intraluminal region, in particular, within an abdominal aortic aneurysm  504 . The prosthesis  500  can be deployed elsewhere in the body. 
         [0146]    The prosthesis  500  desirably includes a fabric material or the like carried by a support frame or scaffold  504 , as previously described. The scaffold  504  can be made, e.g., from an elastic material that self-expands radially during deployment from a sheath, or from a malleable material that expands radially in response to a radially expansive force applied within the scaffold by a balloon or a mechanical expansion device. 
         [0147]    Following deployment of the prosthesis  500  in the targeted region, the integrated fastener assembly  502  on the prosthesis  500  is manipulated to anchor the prosthesis  500  to the vessel wall. In the illustrated embodiment, the prosthesis  500  carries two integrated fastener assemblies  502 , one in each end region of the prosthesis  500 . 
         [0148]    In the illustrated embodiment, each fastener assembly  502  is imbedded in a reinforced flange area  506  in the respective end region. Each fastener assembly  502  comprises an array of fasteners  508  circumferentially spaced about the flange  506 . The number of fasteners  508  in the array can vary, e.g., from about two to about twelve fasteners on each flange area  506 . The configuration of the array can also vary, e.g., in the circumferential array, the fasteners  508  can by axially spaced apart as well. 
         [0149]    The fasteners  508  can be formed of a metal or plastic material and can be variously constructed. In the illustrated embodiment, each fastener  508  includes a disc-shaped head  512  and a stem  514  that is bifurcated into two wings  516  and  518 , which are joined by a plastic or memory material hinge region  520 . The material of the hinge region  520  is formed with a resilient memory that biases the wings  516  and  518  to a spread-apart condition (as  FIG. 34  shows). 
         [0150]    Each fastener  508  is carried within a grommet  510  on the flange area  506  (see  FIG. 35 ). When the hinge region  520  is confined within the grommet  510  (as  FIG. 35  shows), the wings  516  and  518  are retained against the resilient memory in an adjacent, closed condition. In response to the application of a pushing or punching force on the head  512  (see  FIG. 35 ), the wings  516  and  518  are advanced in the closed condition out of the grommet  510 , and into and through the adjacent vessel wall (see  FIG. 36 ). Upon continued advancement, the hinge region  520  is freed from the confines of the grommet  510  (see  FIG. 37 ). As a result, the wings  516  and  518  resiliently spring into their normal spread-apart condition. 
         [0151]    In this arrangement, an intraluminal tool  522  (see  FIG. 33 ) is deployed into the prosthesis  500  to exert a pushing or punching force upon the head  512  of a given fastener  508 . In the illustrated embodiment, the tool  522  comprises a catheter  524  that carries a punch member  526  at its distal end. In a desired arrangement, the distal end of the catheter  524  is steerable, to aid in establishing point contact between the punch member  526  and the head  512  of the given fastener  508 . The head  512  can include a recess  528  to receive and stabilize the tip of the punch member  526  with respect to the head  512  during use (see  FIG. 34 ). 
         [0152]    In use, the punch member  526  is manipulated to apply a pushing or punching force upon the selected fastener head  512 . As  FIGS. 35 and 36  show, the application of the pushing force by the punch member  526  forces the wings  516  and  518  against the near side of the vessel wall  34 . The wings  516  and  518  are still in their closed condition, because the hinge region  520  is still confined within the grommet  510 . The closed wings  516  and  518  form an obturator that penetrates tissue as it advances to the far side of the vessel wall. As the hinge region  510  is freed from the grommet  510  ( FIG. 37 ), the wings  516  and  518  resiliently return to their spread-apart condition against the far side of the vessel wall. Upon removal of the punch member  526  (see  FIG. 38 ), the head  512  and spread-apart wings  516  and  518  remain in their mutually opposed condition in the vessel wall, to secure the prosthesis  500  against the vessel wall. In use, the physician locates and manipulates the punch member  526  in succession against each fastener  508 , to complete the anchorage of the prosthesis  500  to the vessel wall. 
         [0153]    In one embodiment (see  FIG. 39 ), each fastener  508  can include a tracking wire  530  that is releasably coupled to the head  512 . The tracking wire  530  extends from the head  512  outside the body for access outside the vessel. In this arrangement, the punch member  526  includes a lumen to accommodate passage of the tracking wire  530 . The tracking wire  530  guides the punch member  526  in an intraluminal path to the respective fastener  508 . After the punch member  526  is manipulated to drive the fastener  508  into the vessel wall, the punch member  526  can be withdrawn over the tracking wire  530 . The tracking wire  530  can be released from the now-secured head  512 , e.g., by applying a moderate pulling force upon the tracking wire  530 . The tracking wire  530  can then be withdrawn. The punch member  526  is sequentially guided over another tracking wire  530  for interaction with another one of the fasteners  508 , until a desired degree of anchorage is achieved. 
         [0154]    In an alternative embodiment, an integrated fastener assembly  502  on the prosthesis  500  can be used to temporarily tack the prosthesis  500  in place while a permanent anchoring technique is carried out. For example, in this arrangement, after using the integrated fastener assembly  502  to temporarily hold the prosthesis  500  in a desired location, the separate helical fasteners  28  are deployed in the manner previously described, to permanently anchor the prosthesis  500  against the vessel wall. 
         [0155]    It will be appreciated that the components and/or features of the preferred embodiments described herein may be used together or separately, while the depicted methods and devices may be combined or modified in whole or in part. It is contemplated that the components of the directing device, fastener applier and helical fastener may be alternately oriented relative to each other, for example, offset, bi-axial, etc. Further, it will be understood that the various embodiments may be used in additional procedures not described herein, such as vascular trauma, arterial dissections, artificial heart valve attachment and attachment of other prosthetic device within the vascular system and generally within the body. 
         [0156]    The preferred embodiments of the invention are described above in detail for the purpose of setting forth a complete disclosure and for the sake of explanation and clarity. Those skilled in the art will envision other modifications within the scope and sprit of the present disclosure.