Abstract:
In a method of accessing and closing a vessel, a vessel is percutaneously accessed through a first opening in the vessel wall at a first location. A stent-graft is delivered through the first opening to a second location. The stent-graft is deployed at the second location. The vessel is then accessed through a second opening through the vessel wall at the second location, wherein the second opening is generally aligned with a fenestration through the graft material of the stent-graft. A delivery device is advanced through the second opening, the fenestration, and the stent-graft lumen to a third location spaced from the first location and the second location. After the delivery device is retracted through the lumen of the stent-graft and out of the fenestration and the second opening, the stent graft is rotated or translated such that the fenestration is not aligned with the second opening.

Description:
FIELD OF THE INVENTION 
       [0001]    The invention is related in general to n apparatus and method for providing percutaneous access to and closure of a blood vessel and, in particular, to the subclavian artery. 
       BACKGROUND OF THE INVENTION 
       [0002]    Percutaneous access for procedures in body lumens such as blood vessels is desirable to minimize complications from surgical procedures. Procedures using percutaneous access are also referred to as minimally invasive procedures. Many percutaneous procedures involving the aorta, coronary arteries, or other vessels near the heart rely on percutaneous access via the femoral artery. Access via the femoral artery is preferred for transcatheter aortic valve implantation (TAVI) procedures since it enables the clinician to routinely perform the procedure percutaneously. The subclavian/axillary artery is considered a backup access site when the femoral artery and/or associated pathway to the aortic valve precludes delivery due to tortuosity, heavy calcification, and/or vascular disease. The subclavian/axillary artery is a backup access site since it generally requires a surgical cutdown procedure, unlike the femoral artery which can be accessed percutaneously. In other ways, however, subclavian artery access for a TAVI procedure has distinct advantages over a TAVI procedure using femoral access. For example, and not by way of limitation, subclavian artery access for TAVI procedures allows for better control of the delivery catheter and the bioprosthesis during delivery. Subclavian artery access for TAVI procedures also eliminates the need for any groin sticks since all intervention can be accomplished above the waist. This latter advantage enables patients to potentially become mobile sooner than with the femoral access procedures. Disadvantages of subclavian access for procedures include difficulty in accessing and closing the subclavian artery that is significantly less superficially located (i.e., deeper) than the femoral artery. As noted above, accessing the subclavian artery normally requires a surgical cut-down procedure. Also, while the access point to the femoral artery can normally be closed by compression (such as a weight placed in the access region), access to the subclavian artery cannot be closed with compression due to the depth of the artery and the location of the clavicle. Thus, a surgical technique is normally required to close the access point of the subclavian artery, such as the use sutures to close the access hole/arteriotomy. 
         [0003]    Accordingly, it would be desirable to provide percutaneous access to the subclavian artery in order to take advantage of the advantages provided by access via the subclavian artery while eliminating the disadvantages due to the current lack of percutaneous access via the subclavian artery and difficulties in closing access to the subclavian artery. Facilitating a percutaneous subclavian/axillary artery access for TAVI procedures may result in improved TAVI outcomes as well as providing an even more competitive alternative for sites performing transapical TAVI procedures. 
       BRIEF SUMMARY OF THE INVENTION 
       [0004]    Embodiments hereof relate to a method of accessing and closing a vessel. In one embodiment, a vessel is percutaenously accessed through a first opening in the vessel wall at a first location. A stent-graft is delivered in a radially compressed configuration through the first opening to a second location spaced from the first location. The stent-graft includes a plurality of stents, graft material coupled to the stents, a first end, a second end, a lumen, and a fenestration through the graft material between the first end and the second end. The stent-graft is deployed at the second location such that the stent-graft expands from the radially compressed configuration to a radially expanded configuration. The vessel is then accessed through a second opening through the vessel wall at the second location, wherein the second opening is generally aligned with the fenestration in the stent-graft such that the lumen of the stent-graft can be accessed through the second opening and the fenestration. A delivery device is advanced through the second opening, the fenestration, and the stent-graft lumen to a third location spaced from the first location and the second location. After a procedure at the third location, the delivery device is retracted through the lumen of the stent-graft and out of the fenestration and the second opening in the vessel wall. The stent graft is then rotated or translated such that the fenestration is not aligned with the second opening. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0005]    The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The drawings are not to scale. 
           [0006]      FIG. 1  is a schematic side view of stent-graft to support a vessel for percutaneous access to the vessel. 
           [0007]      FIG. 2  is a top view of a portion of the stent-graft of  FIG. 1 . 
           [0008]      FIG. 3  is schematic side view of a radiopaque ring disposed around a fenestration of the stent-graft of  FIG. 1 . 
           [0009]      FIG. 4  is a schematic of a human heart and arteries of the upper body and upper limbs. 
           [0010]      FIGS. 5-19B  are schematic illustrations of a method for perutaneous access and closure of a vessel utilizing the stent-graft of  FIG. 1 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0011]    Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. Specific embodiments are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. Unless otherwise indicated, for the delivery system the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. For the stent-graft prosthesis “proximal” is the portion nearer the heart by way of blood flow path while “distal” is the portion of the stent-graft further from the heart by way of blood flow path. In addition, the term “self-expanding” is used in the following description with reference to one or more stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in embodiments hereof to include polymers such as polynorborene, trans-polyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers. 
         [0012]    The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of the invention is in the context of treatment of percutaneous access to the left subclavian artery for transcatheter aortic valve implantation procedures, the invention may also be used in any other body passageways and for other procedures where it is deemed useful. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. 
         [0013]    With reference to  FIGS. 1-3 , a stent-graft  100  is configured for placement in a vessel such as the sublavian artery. Stent-graft  100  includes graft material  102  coupled to stents  104 . Graft material  102  may be coupled to stents  104  using stitching  110  or other means known to those of skill in the art. In the embodiment shown in  FIGS. 1-3  stents  104  are coupled to an outside surface of graft material  102 . However, stents  104  may alternatively be coupled to an inside surface of graft material  102 . Graft material  102  may be any suitable graft material, for example and not limited to, woven polyester, DACRON material, expanded polytetrafluoroethylene, polyurethane, silicone, or other suitable materials. Stents  104  may be any conventional stent material or configuration. As shown, stents  104  are preferably made from a shape memory material, such as thermally treated stainless steel or nickel-titanium alloy (nitinol), and are formed into a zig-zag configuration. Stent-graft  100  includes a proximal end  106 , a distal end  108 , and a body  107  therebetween. Proximal stent  112  and distal stent  114  may or may not extend beyond the ends of the graft material  102 . In the embodiment shown, proximal stent  112  does not extend beyond a proximal end of the graft material and distal stent  114  does extend beyond a distal end of the graft material  102 . Body  107  has a lumen  116  disposed therethrough. Stent-graft  100  further includes a fenestration  120 , described in detail below. Stent graft- 100  may be a variation of conventional thoracic stent grafts, such as Medtronic, Inc.&#39;s VALIANT® thoracic stent-graft, or other known stent-grafts. 
         [0014]    Fenestration  120  is disposed through a side surface of stent-graft  100  and is an opening through graft material  102 . Fenestration  120  may be any shape, but is preferably round or oval in shape. Fenestration  120  is sized and shaped such that a catheter utilized for a procedure such as a transcatheter aortic valve implantation may extend through fenestration  120 . For example, and not by way of limitation, fenestration  120  may have a long axis of approximately 6-12 mm and a short axis of approximately 4-10 mm. Similarly, a circular fenestration may have a diameters in the range of 6-12 mm. However, those skilled in the art would recognize that the size of fenestration  120  can be selected to be slightly larger than the catheter or introducer to be inserted therethrough. A radiopaque ring  122  is disposed around fenestration  120 . Radiopaque ring  122  provides a target for percutaneous access through the vessel and stent-graft  100 , as describe in more detail below. Radiopaque ring  122  may be made of materials generally considered radiopaque by those skilled in the art. For example, and not by way of limitation, radiopaque ring may be made from tantalum, tungsten, molybdenum, niobium, rhenium, carbon, germanium, silicon, and other materials known to those skilled in the art as radiopaque, and alloys thereof. For the purposes of this disclosure, radiopaque will refer to those substances or materials which have suitable visibility for percutaneous procedures when being imaged by an X-ray imaging device such as but not limited to a fluoroscope. Radiopaque ring  122  may be coupled to graft material  102  using stitches or other similar coupling means. For example, and not by way of limitation, graft material  102  may be folded over radiopaque ring  122  and the folded over portion of the graft material  102  may be stitched to itself to capture radiopaque ring  122 . 
         [0015]      FIG. 4  is a schematic illustration of the arteries of the upper body and upper limbs of a human. In particular,  FIG. 4  shows a heart  200  with an aorta extending from the left ventricle of heart  200 . The aorta bends to form an aortic arch  202  and extends to the descending or thoracic aorta to the abdominal aorta. Emanating from the aortic arch  202  are three branch arteries, the innominate or brachiocephalic artery  204 , the left common carotid artery  214 , and the left subclavian artery  216 . The brachiocephalic artery  204  branches into the right common carotid artery  206  and the right subclavian artery  208 . The right subclavian artery  208  becomes the right axillary artery  210  in the right armpit region of the body, and extends to become the right brachial artery  212  in the right upper arm. The left subclavian artery  216  becomes the left axillary artery  218  in the left armpit region of the body, and extends to become the left brachial artery  220  in the left upper arm. 
         [0016]      FIGS. 5-19B  show schematically an example of method for accessing a vessel for delivery of an interventional device through the vessel, and subsequent closing of the access opening through a wall of the vessel. In the embodiment shown, the method is shown and described with respect to access through the left brachial artery  220  to deliver stent-graft  100  to a desired location in the left subclavian artery  216 , and subsequent access through the wall of the left subclavian artery  216  and fenestration  120  in stent-graft  100  to deliver the interventional device to a desired location. However, those of ordinary skill in the art would understand that the method is not limited to the particular location described. In particular, but not by way of limitation, access for delivery of stent-graft  100  may be through the right brachial artery  212  to the right subclavian artery  208  for subsequent access through the wall of the right subclavian artery  208  and fenestration  120  of stent-graft  100  for delivery of the interventional device. Further, access through the subclavian artery may be through the axillary artery. Since the axillary artery is an extension of the subclavian artery, the terms may be used interchangeably herein. The devices and methods may also be used at other locations. 
         [0017]      FIG. 5  is a schematic drawing showing the step of accessing the left brachial artery  220  through an opening or arteriotomy  222  through the wall of the left brachial artery  220 . This step can be accomplished through methods known to those of ordinary skill in the art, such as, but not limited to, the Seldinger technique. A guidewire  302  is advanced through arteriotomy  222  through a lumen  224  of brachial artery  220 , left axillary artery  218  (not shown in  FIG. 5 ), and into the left subclavian artery  216 . 
         [0018]    A stent-graft delivery system  300  is then advanced over guidewire  302  from arteriotomy  222  to a desired location in the left subclavian artery  216 , as shown in  FIG. 6 . Although the location is shown in left subclavian artery  216 , the location may be near where the left subclavian artery becomes the left axillary artery  218  or may be in the left axillary artery  218 . Delivery system  300  may be any delivery system known to those of ordinary skill in the art that can deliver a stent-graft to a desired location. Described generally, delivery system  300  includes a tapered tip  306  that is flexible and able to provide trackability in tight and tortuous vessels. Other tip shapes such as bullet-shaped tips could also be used. The tip  306  includes a lumen disposed therethrough for accommodating guidewire  302 . A sleeve  308  of stent-graft delivery system  300  extends over stent-graft  100  and abuts against a proximally facing surface of tip  306 . Delivery system  300  also includes an inner tube or shaft  304  that is coupled to the tip lumen such that guidewire  302  may extend the length of delivery system  300 . A stop  310  is located at a distal end of stent-graft  100  when stent-graft  100  is loaded onto the delivery system  300 . Stop  310  prevents longitudinal movement of stent-graft  100  as sleeve  308  is retracted or otherwise removed to release stent-graft  100 . Stent-graft  100  is disposed within sleeve  308  in a compressed or delivery configuration wherein the diameter of stent-graft  100  is reduced such that it can be inserted through the vasculature. 
         [0019]    Once delivery system  300  is in the desired location, sleeve  308  is retracted proximally, as shown in  FIG. 7 . As sleeve  308  is retracted, the proximal end of stent-graft  100  begins to expand. As sleeve  308  is further retracted proximal to distal end of stent-graft  100 , stent-graft  100  fully expands, as shown in  FIG. 8 . With stent-graft  100  fully expanded, fenestration  120  faces a wall of left subclavian atrery  216 , as shown in  FIG. 9 . Delivery system  300  may be removed or may remain partially coupled to stent-graft  100  to re-position stent-graft  100  after the interventional procedure is completed, as described in more detail below. 
         [0020]    With stent-graft  100  in the desired location, an access opening or arteriotomy  217  is formed through a wall of left subclavian artery  216  in alignment with fenestration  120  of stent-graft  100 , as shown in  FIG. 10 . An interventional delivery device  400 , such as a device for delivering and deploying an aortic valve in a transcatheter aortic valve implantation (TAVI) procedure, is inserted into arteriotomy  217 . Such delivery devices are known to those skilled in the art. For example, and not by way of limitation, interventional delivery device  400  may be the Medtronic CoreValve Delivery Catheter System, with or without the AccuTtrak™ Stability Layer, as described at http://www.medtronic.com/corevalve/ous/downloads/201006136_EE.pdf, or the delivery systems described in U.S. Patent Application Publication Nos. 2011/0251680 and 2011/0264201, the teachings of each of which are incorporated herein by reference. The delivery device  400  may be for delivery and implanting a stented prosthetic valve, such as, a prosthetic valve sold under the trade name CoreValve® available from Medtronic CoreValve, LLC. Other non-limiting examples of transcatheter heart valve prostheses useful with systems and methods of the present disclosure are described in U.S. Patent Application Publication Nos. 2006/0265056; 2007/0239266; and 2007/0239269, the teachings of each of which are incorporated herein by reference. With stent-graft  100  providing support for the left subclavian artery  216  and radiopaque ring  122  providing a target location within the subclavian artery  216 , a Seldinger or modified technique may be used to gain access to the left subclavian artery. Other methods of gaining access to the left subcalvian artery, such as a cut-down procedure described in a brochure at http://www.medtronic.com/corevalve/ous/downloads/201104711aEE.pdf may also be used. Additional devices, such as an introducer or dilator  402 , as known to those skilled in the art may also be used for delivery device  400  to gain access through arteriotomy  217 . 
         [0021]    After interventional delivery system  400  is inserted through arteriotomy  217 , it is advanced along a guidewire  402  to the desired site, as shown schematically in  FIG. 11 . In the present non-limiting example, interventional delivery device  400  is advanced to the site of the aortic valve  226  such that a prosthetic heart valve  420  may be implanted by methods known to those skilled in the art, after prosthetic heart valve  226  is implanted, interventional delivery device  400  may be retracted and removed from subclavian artery  216  through arteriotomy  217 .  FIG. 12  shows schematically delivery device  400  partially retracted after prosthetic heart valve  420  has been implanted. 
         [0022]    After interventional delivery device  400  is removed, a recapture catheter or device  500  may be advanced from the brachial artery  220  to the subclavian artery  216 , adjacent to the distal end  108  of stent-graft  100 , as shown schematically in  FIG. 13 . Recapture device  500  may be the same as stent-graft delivery system  300  or may be a different device. Recapture device  500  may be any recapture device known to those skilled in the art. For example, and not by way of limitation, recapture device  500  delivery catheter may be as described in U.S. Pat. Nos. 5,843,167; 5,902,334; and 5,961,546, the teachings of each of which is incorporated in its entirety by reference herein. Recapture device  500  recaptures stent-graft  100  such that stent-graft  100  is converted from the radially expanded configuration to a radially compressed configuration, as shown in  FIGS. 13-15 . 
         [0023]    Further, instead of stent-graft delivery system  300  being completely withdrawn after stent-graft  100  is implanted, a capture mechanism  320  may maintain control of distal stent  114  of stent-graft  100  after stent-graft  100  is deployed. In such a situation, distal stent  114  may not fully deploy. For example, and not by way of limitation, the capture devices described in U.S. Patent Application Nos. 2008/0262590 and 2011/0251664, each of which is incorporated by reference herein in its entirety, may be used to maintain control of distal stent  114  of stent-graft  100  after sleeve  308  has been fully retracted. In such a method, after sleeve  308  has been retracted, distal stent  114  remains captured by a capture mechanism. Tip  306  may be partially retracted past fenestration  120  such that interventional delivery device  400  may be inserted through fenestration  120  and advanced to the treatment site. Upon withdrawal of interventional delivery device  400 , tip  306  may be advanced distally beyond proximal end  106  of stent-graft  100  and sleeve  308  may be advanced distally over stent graft  100  to recapture stent-graft  100 , as shown in  FIGS. 16-18 . 
         [0024]    As shown schematically in  FIGS. 15 and 18 , after stent-graft  100  is recaptured within recapture device  500  or delivery system  300 , recapture device  500  or delivery system  300  may either be translated as shown by arrows  550 / 350  or rotated as shown by arrows  552 / 352 . After stent-graft  100  has been translated or rotated, stent-graft can be released from recapture device  500  or delivery system  300 . If delivery system is used, capture mechanism  320  may also be released to fully deploy stent-graft  100 . If recapture device  500  or delivery system  300  is rotated, stent-graft  100  is also rotated such that fenestration  120  is not aligned with arteriotomy  217 , a shown in  FIG. 19A . Thus, a portion of graft material  102  of stent-graft  100  covers arteriotomy  217  such that blood cannot escape through arteriotomy  217 . Similarly, if recapture device  500  or delivery system  300  is translated, stent-graft  100  is also translated such that fenestration  120  is not aligned with arteriotomy  217 , as shown in  FIG. 19B . Thus, a portion of graft material  102  of stent-graft  100  covers arteriotomy  217  such that blood cannot escape through arteriotomy  217 . This alleviates the need to suture arteriotomy  217 . 
         [0025]    While various embodiments according to the present invention have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. For example, in the above embodiments, the scaffolding or support of the stent-graft prostheses have been illustrated as a series of independent or separate self-expanding stents/sinusoidal patterned rings. However, as will be understood by those of ordinary skill in the art, the support structure or scaffolding of a stent-graft prosthesis may have other configurations such as a series of sinusoidal patterned rings coupled to each other to form a self-expanding stent. In another embodiment, the support structure or scaffolding of a stent-graft prosthesis may be a unitary tubular component having diamond-shaped opening, which may be formed by various conventional stent forming methods as would be understood by one of ordinary skill in the art. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.