Patent Publication Number: US-2023149004-A1

Title: Blood vessel access and closure devices and related methods of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application claims the benefits of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62/450,257, filed Jan. 25, 2017, and to U.S. Provisional Application No. 62/525,839, filed Jun. 28, 2017, the entireties of which are incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     Embodiments of the present disclosure relate to devices for accessing a blood vessel by creating an opening through a wall of the blood vessel, and for subsequently closing the opening, and related methods of use. 
     BACKGROUND 
     Various mechanisms are available for accessing a blood vessel in order to perform a medical procedure inside the blood vessel or other part of the cardiovascular system. However, many conventional techniques position a sheath or other member within the blood vessel, restricting the field of view within the vessel, and restricting the ability to navigate tools both proximally and distally of the point of insertion. Additionally, procedure times for conventional techniques may be higher than optimal. 
     SUMMARY 
     In one aspect, the disclosure is directed to a medical device including an outer assembly having a first shaft, a first lumen extending through the first shaft, and an atraumatic first tip removably coupled to a distal end of the first shaft; an inner assembly configured to extend through the first lumen of the outer assembly, the inner assembly including a second shaft, a second lumen extending through the second shaft, and a second tip removably coupled to a distal end of the second shaft, the second tip being configured to pierce tissue; and a plug assembly configured to extend through the second lumen of the inner assembly, the plug assembly including a third shaft and a plug removably coupled to a distal end of the third shaft. 
     The first tip may include a first tip lumen, the second tip may extend through the first tip lumen, and the second tip may include a protrusion configured to engage with the first tip and secure the first tip to the second tip. The protrusion may extend proximally from a proximal end of the second tip, and is configured to engage with a proximal end of the first tip via a snap-fit. The first tip may include a first bevel at a distal end of the first tip. The second tip may include a second bevel configured to pierce tissue at a distal end of the second tip. The second tip may include a first flange extending proximally from the second bevel at an angle offset from a longitudinal axis of the second tip. The first flange may include a first part and a second part pivotable relative to the first part by a hinge. In a first configuration, the second part may extend at a first angle to the longitudinal axis of the second tip, and in a second configuration, the second part may extend at a second angle to the longitudinal axis of the second tip, wherein the second angle is different than the first angle. Pulling the inner assembly proximally may cause the second part to pivot from the first configuration to the second configuration. The hinge may be a living hinge. The second tip may include a second tip lumen extending through the second tip, an inner surface surrounding a distal portion of the second tip lumen, and a second flange extending radially inward from the inner surface and surrounding a proximal portion of the second tip lumen. The plug may be a solid member without lumens, may include a bevel at a distal end, and may include a third flange extending circumferentially around a portion of the plug, wherein a distally-facing surface of the third flange is configured to abut a proximal-facing surface of the second flange when the plug is extended through the second lumen. The second tip may include a recess at a distal end of the second tip, the recess extending only partially around a circumference of the second tip, and the plug may include a protrusion configured to be received by the recess, the protrusion extending only partially around a circumference of the plug. One or more of the first tip, the second tip, and the plug may be bioresorbable. Each of the first tip, the second tip, and the plug may be bioresorbable. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments. 
         FIGS.  1 - 3 ,  3 A, and  4 - 6    illustrate a method of accessing a blood vessel for a procedure, and for sealing the blood vessel after the procedure. 
         FIG.  7    illustrates various components of a medical kit according to an example of the present disclosure. 
         FIGS.  8 - 12    illustrate an inner assembly having a piercing tip according to an example of the present disclosure. 
         FIGS.  13 - 18    illustrate an outer assembly having a distal tip according to an example of the present disclosure. 
         FIGS.  19 - 24    illustrate a plug assembly having a plug according to an example of the present disclosure. 
         FIGS.  25 - 30    illustrate the inner assembly of  FIGS.  8 - 12   , the outer assembly of  FIGS.  13 - 18   , and the plug assembly of  FIGS.  19 - 24    used together in various configurations. 
         FIG.  31    is a schematic illustration of an example of closing an opening to a blood vessel using a suture. 
         FIG.  32    is a schematic illustration of accessing a blood vessel using multiple sheaths. 
         FIG.  33    is a schematic illustration of a filter assembly in a blood vessel. 
         FIGS.  34 - 36    illustrate another embodiment of a piercing tip for use with an inner assembly. 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made in detail to exemplary embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts or components. The term “distal” refers to the direction that is away from the user or operator and into the patient&#39;s body. By contrast, the term “proximal” refers to the direction that is closer to the user or operator and away from the patient&#39;s body. 
     The present disclosure is directed to devices for accessing a blood vessel, such as, e.g., a femoral artery, a carotid artery, or any other artery or vein. An exemplary method is shown in  FIGS.  1 - 3 ,  3 A, and  4 - 6    using a medical kit. The medical kit is described in more detail with reference to  FIGS.  7 - 30   . 
     Referring to  FIG.  7   , the medical kit may include an inner assembly  100 , an outer assembly  200 , a plug assembly  300 , and a dilator  400 . Dilator  400  may be any suitable device configured to dilate a body lumen, including expandable dilators. Dilator  400  may be removably coupled to inner assembly  100  so that dilator  400  and inner assembly  100  may be inserted simultaneously into a blood vessel. 
     Various portions of inner assembly  100  are shown in  FIGS.  8 - 12   . Inner assembly  100  may extend from a proximal end  102  to a distal end  104 , and may include a shaft  106  that is coupled to a piercing tip  108  at distal end  104 . The shaft  106  may include one or more lumens extending therethrough. Shaft  106  also may include one or more openings  110  extending through a wall of shaft  106 . In one example, shaft  106  may include two diametrically opposed openings  110  near its distal end. 
     Piercing tip  108  has a body that extends from a proximal end  109  to a distal end  110 , and may include a bevel  111  at distal end  110  that is configured to pierce through tissue. Piercing tip  108  also may include a flange  112  that extends proximally from bevel  111 . In some examples, flange  112  may lie in the same plane as bevel  111 . In some examples, flange  112  extends from only a proximal portion of bevel  111 . Flange  112 , and particularly its proximal-facing surface, may include a tacky coating and/or bioadhesive to help maintain flange  112  against tissue. A lumen  113  may extend from proximal end  109  to distal end  110 . Piercing tip  108  may include a circumferential rim  114  at proximal end  109 , and a circumferential flange  116  disposed distally of rim  114 . The flange  116  may extend radially inward from an inner surface  118  of piercing tip  108 . The flange  116  may have a smaller diameter than rim  114 . A locking arm  120  may extend proximally from rim  114 . Locking arm  120  may include a radially-outward extending protrusion  121 . Piercing tip  108  also may include a recess  122  at distal end  110 , which may be used in a snap fit engagement with a portion of plug assembly  300 , as discussed in further detail below. Piercing tip  108  also may include one or more openings  124  extending through its body and in communication with lumen  113 . In one example, piercing tip  108  may include diametrically opposed openings  124  that align with openings  110  of shaft  106 . 
     Piercing tip  108  may be coupled to a distal end of shaft  106  via a connecting member  130 . The connecting member  130  may extend outside of the one or more lumens of shaft  106  and through openings  110  of shaft  106  and openings  124  of piercing tip  108 , to secure the piercing tip  108  to shaft  106 . The connecting member  130  may be a suture, wire, thread, or other suitable connecting member. Opposing ends  132  of connecting member  130  may extend proximally when piercing tip  108  and shaft  106  are coupled to one another. In one example, tension may be applied to those ends  132 . Piercing tip  108  may be configured to detach from shaft  106 . In one example, tension may be released from one of the ends  132 , allowing connecting member  130  to be removed from the device by pulling on the other end  132 . In another example, connecting member  130  may include one or more frangible links that are configured to break when a sufficient pulling force is applied to ends  132 , allowing separation of piercing tip  108  from shaft  106 . 
     Referring to  FIG.  7   , inner assembly  100  may include an access port  150  and a conduit  152  at proximal end  102 . Access port  150  may be used to deliver various tools through one or more lumens of inner assembly  100 , and conduit  152  may be used for suction, irrigation, aspiration, or other fluid-related tasks. In one example, conduit  152  may be used to provide a saline flush. A pressure sensor may disposed in access port  150  or in another suitable location of inner assembly  100  to monitor pressure within a blood vessel. 
     Various portions of outer assembly  200  are shown in  FIGS.  13 - 18   . Outer assembly  200  may extend from a proximal end  202  to a distal end  204 , and may include a shaft  206  that is coupled to a distal tip  208  at distal end  204 . The shaft  206  may include one or more lumens extending therethrough. Shaft  206  also may include one or more openings  210  extending through a wall of shaft  206 . In one example, shaft  206  may include two diametrically opposed openings  210  near its distal end. 
     Distal tip  208  has a body that extends from a proximal end  209  to a distal end  210 , and may include a bevel  211  at distal end  210  that is configured to clamp onto tissue. In some examples, the bevel  211  may be atraumatic to prevent excessive damage to tissue when used as a clamp. Bevel  211  may include a tacky coating and/or bioadhesive in order to help secure bevel  211  against tissue. A gauze or other fabric may be coupled to bevel  211  to absorb excess bodily fluids and to facilitate healing during closure of an access opening to a blood vessel. Proximal end  209  may include a generally cylindrical portion  215  configured to slide into a lumen of shaft  206 . Distal tip  208  also may include a proximally-facing circumferential flange  212  configured to abut the distal end of shaft  206 . A lumen  213  may extend from proximal end  209  to distal end  210 . Distal tip  208  also may include one or more openings  224  extending through cylindrical portion  215  and in communication with lumen  213 . In one example, distal tip  208  may include diametrically opposed openings  224  that align with openings  210  of shaft  206 . 
     Distal tip  208  may be coupled to a distal end of shaft  206  via a connecting member  130  that is substantially similar to the connecting member  130  previously described. The connecting member  130  may extend through openings  224  of distal tip  208  and at least partially around a circumference of cylindrical portion  215 . The ends  132  of the connecting member  130  then may be passed through openings  210  of shaft  206 , the lumen of shaft  206 , and proximally out of shaft  206 . 
     Various portions of plug assembly  300  are shown in  FIGS.  19 - 24   . Plug assembly  300  may extend from a proximal end  302  to a distal end  304 , and may include a shaft  306  that is coupled to a plug  308  at distal end  304 . The shaft  306  may include one or more lumens extending therethrough. Shaft  306  also may include one or more openings  310  extending through a wall of shaft  306 . In one example, shaft  306  may include two diametrically opposed openings  310  near its distal end. 
     Plug  308  has a body that extends from a proximal end  309  to a distal end  310 , and may include a bevel  311  at distal end  310 . In some examples, the bevel  311  may be a solid member (having no lumens or extensions therethrough) in order to seal an opening created through a wall of a blood vessel. Proximal end  309  may include a generally cylindrical portion  315  configured receive a distal end of shaft  306  in a lumen  313 . Distal tip  308  also may include a circumferential flange  312  configured to abut flange  116  of inner assembly  100 . Lumen  313  may extend from proximal end  309  toward distal end  310 , and may be closed off at a distal end by a proximal surface of bevel  311 . Plug  308  also may include one or more openings  324  extending through cylindrical portion  315  and in communication with lumen  313 . In one example, plug  308  may include diametrically opposed openings  324  that align with openings  310  of shaft  306 . Plug  308  also may include a locking protrusion  330  extending radially outward from a proximalmost portion of the bevel  311 . As shown in  FIG.  22   , plug  308  may be covered with a graft  340 , such as, e.g., an ePTFE graft to promote tissue growth after insertion through a blood vessel wall. 
     Distal tip  308  may be coupled to a distal end of shaft  306  via a connecting member  130  that is substantially similar to the connecting member  130  previously described. The connecting member  130  may extend through openings  324  of plug  308  and at least partially around a circumference of cylindrical portion  315 . The ends  132  of the connecting member  130  then may be passed through openings  310  of shaft  306 , a lumen of shaft  306 , and proximally out of shaft  306 . 
     All or portions of inner assembly  100 , outer assembly  200 , and plug assembly  300  may be formed from biocompatible materials. Examples of such materials may include, but are not limited to, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), polyethylene terephthalate (PET), perfluoroalkoxy (PFA), polyether ether ketone (PEEK), polypropylene (PP), silicone, polycarbonate, polyurethane, LDPE, HDPE or the like. In some embodiments, one or more portions of the inner assembly  100 , outer assembly  200 , and plug assembly  300 , may be formed from bioresorbable materials, including, for example, polyglycolide (PGA), polylactide (PLA), and/or polycaprolactone (PCL). When bioresorbable materials are used, different bioresorbable materials may be used that regrade at different rates. In one example, one or more of piercing tip  108 , distal tip  208 , and plug  308  may include a bioresorbable material. 
       FIGS.  25 - 30    show the relationship of inner assembly  100 , outer assembly  200 , and plug assembly  300 . In one example, outer assembly  200  may be configured to surround inner assembly  100 , and thus, inner assembly  100  may have a smaller diameter than outer assembly  200  so as to fit within a lumen of outer assembly  200 . Further, plug assembly  300  may be configured to slide within a lumen of inner assembly  100  as shown in  FIG.  25   . Thus, shafts  206 ,  106 , and  306  may be nested in certain configurations of the medical kit. Additionally, distal tip  208 , piercing tip  108 , and plug  308  may be nested in certain configurations, with distal tip  208  surrounding piercing tip  108 , and piercing tip  108  surrounding plug  308 . 
     Distal tip  208  and piercing tip  108  may have corresponding features that cooperate to secure distal tip  208  and piercing tip  108  together. For example, locking arm  120  of inner assembly  100  may be configured to engage proximal end  209  of distal tip  208 . For example, distal tip  208  may be advanced distally over piercing tip  108  until locking arm  120  clears proximal end  209  of distal tip  208 , causing distal tip  208  and piercing tip  108  to form a locked configuration relative to one another. The protrusion  121  of locking arm  120  may engage proximal end  209  of distal tip  208 . Also, locking arm  120  may be a cantilevered arm that may flex radially inward and outward during engagement with distal tip  208 . Once locking arm  120  clears proximal end  209 , piercing tip  108  may be prevented from moving distally relative to distal tip  208  due to the engagement of locking arm  120  with proximal end  209  of distal tip  208 . 
     Piercing tip  108  and plug  308  also may have corresponding features that cooperate to secure piercing tip  108  to plug  308 . For example, piercing tip  108  includes a recess  122  configured to receive locking protrusion  330  of plug  308 . Also, flange  116  of piercing tip  108  may be configured to abut the distally-facing surface of flange  312 . Thus, in some examples, plug  308  may be advanced distally through the proximal end  109  of piercing tip  108  until locking protrusion  330  engages with recess  122 . Once locking protrusion  330  engages with recess  122 , plug  308  may be prevented from moving proximally relative to piercing tip  108  due to the engagement of locking protrusion  330  and recess  122 . In some examples, the engagement of locking protrusion  330  with recess  122  may require precise circumferential alignment between piercing tip  108  and plug  308 . Additionally, plug  308  may be prevented from moving distally relative to piercing tip  108  due to the engagement of flange  116  and flange  312 . 
       FIGS.  1 - 6    illustrate a method of accessing a blood vessel  1000  using the medical kit described with reference to  FIGS.  7 - 30   . Referring to  FIG.  1   , the method may begin with the kit in an insertion configuration where outer assembly  200  is positioned around inner assembly  100 . Blood vessel  1000  may first be accessed by guidewire  500  through an opening made by any suitable puncture device (not shown), and then inner assembly  100 , outer assembly  200 , and dilator  400  may be advanced separately or simultaneously over guidewire  500 . Once dilator  400  pierces through blood vessel wall  1002 , blood may enter a side-hole of dilator  400  and travel proximally through dilator  400  so as to be visible at proximal end  102 , providing a visual indication that the blood vessel  1000  has been accessed by dilator  400 . Then, blood vessel  1000  may be accessed by piercing a wall  1002  with piercing tip  108  (and inner assembly  100 ) in a bevel up configuration where the bevel  111  faces away from the operator. Outer assembly  200  also may be in a bevel up configuration while piercing tip  108  is in the bevel up configuration. In a bevel up configuration, piercing tip  108  may initially contact tissue only with its distalmost point, whereas, in a bevel down configuration, the face of bevel  111  may make initial contact with tissue. In the bevel down configuration, the proximalmost portion of bevel  111  may contact tissue before, or at the same time, as a distalmost portion of bevel  111 . 
     Referring to  FIG.  2   , an operator may rotate inner assembly  100  and/or outer assembly  200  after blood vessel  1000  has been accessed by piercing tip  108  such that both inner assembly  100  and outer assembly  200  are in a bevel down configuration where bevel  111  and  211  face toward from the user. In some embodiments, inner assembly  100  may not be rotated after blood vessel  1000  is accessed by piercing tip  108 . 
     Referring to  FIG.  3   , once piercing tip  108  is in the bevel down configuration within blood vessel  1000 , inner assembly  100  may be pulled proximally to cause flange  112  to abut the inner surface of blood vessel wall  1002 . As alluded to above, inner assembly  100  may not be rotated after piercing tip  108  accesses blood vessel  1000 , and inner assembly  100  may be pulled proximally while piercing tip  100  is in the bevel up configuration to cause flange  112  to abut the inner surface of blood vessel wall  1002 . In some examples, the operator may be required to maintain a proximal pulling force on inner assembly  100 . However, in other examples, a proximal pulling force may be maintained by various mechanical or electromechanical mechanisms so that the operator is free to perform other tasks. Referring to  FIG.  3 A , once flange  112  is secured against the inner surface of blood vessel wall  1002 , outer assembly  200  may be pushed down (distally) such that bevel  211  (and distal tip  208  of outer assembly) comes into contact with skin or the outer surface of blood vessel wall  1002 , forming a clamp with piercing tip  108 . As outer assembly  200  is pushed distally, locking arm  120  (and protrusion  121 ) of inner assembly  100  may engage proximal end  209  of distal tip  208 , securing piercing tip  108  and distal tip  208  together. Once locking arm  120  is engaged with proximal end  209  of outer assembly  200 , piercing tip  108  may be prevented from moving distally relative to distal tip  208 . Piercing tip  108  also may be prevented from moving further proximally due to the engagement of flange  112  with the inner surface of blood vessel wall  1002 . Tacky coatings and/or bioadhesives applied to the surfaces of flange  112  and bevel  211  also may help secure piercing tip  108  and distal tip  208  in place during closure of the opening in blood vessel wall  1002 . 
     Once piercing tip  108  and distal tip  208  are secured to one another, dilator  400  and guidewire  500  may be removed from a lumen of inner assembly  100  ( FIG.  4   ), and a suitable therapeutic or diagnostic procedure may be performed in blood vessel  1000 . The procedure may be performed in the absence of any sheath, scope, or other tool within blood vessel  1000 . This may allow for easier manipulation of tools within blood vessel  1000 , and for procedures to be performed both proximally and distally of the opening created in blood vessel wall  1002 . 
     After completion of the procedure, the tools used during the procedure may be removed from blood vessel  1000 , and plug assembly  300  may be inserted through inner assembly  100  ( FIG.  5   ) until plug  308  engages with piercing tip  108  to close the opening. As set forth above, locking protrusion  330  of plug  308  may engage with recess  122  of piercing tip  108 . Also, flange  116  of piercing tip  108  may be abut the distally-facing surface of flange  312  to prevent plug  308  from entering blood vessel  1000 . 
     Once piercing tip  108 , distal tip  208 , and plug  308  are engaged with one another, shafts  106 ,  206 , and  306  may be removed by pulling on connecting member ends  132  as described above. Thus, after completion of the procedure, a closure device comprising only piercing tip  108 , distal tip  208 , and plug  308  may remain coupled to the blood vessel wall  1002 . In some examples, the entirety of the closure device may resorb within 30 to 90 days. In other examples, where the components of the closure device are non-resorbable, the closure device may be removed in a subsequent procedure, if desired. 
     In an alternative example shown in  FIG.  31   , distal tip  208  may not be used to close the opening through blood vessel wall  1002 . Instead, distal tip  208  and the remainder of outer assembly  200  may be retracted proximally and/or otherwise detached from inner assembly  100  (or not used at all), and a suture knot  3102  may be used to close the opening after plug  308  has been inserted through the opening. Collagen, hydrogel, or another suitable dressing  3104  may be applied to the opening and/or suture knot  3102  to facilitate healing. 
     In another example shown in  FIG.  32   , a second procedural sheath  3202  may be inserted through inner assembly  100  and into blood vessel  1000 . The second procedural sheath may direct and/or divert catheters, tools, and other medical devices into the blood vessel  1000  and may help prevent puncture of an opposing surface of blood vessel wall  1002 . 
     In yet another example shown in  FIG.  33   , a filter system  3300  may be placed into blood vessel  1000  downstream of the opening through blood vessel wall  1002 . Placement of the filter system  3300  downstream of the opening may help capture tissue or other materials that come loose and enter the bloodstream, helping to prevent an embolism caused by the loose materials. In one example, the filter system  3300  is used when blood vessel  1000  is the carotid artery. 
       FIGS.  34 - 36    illustrate another embodiment of a piercing tip for use with an inner assembly in the same way that other piercing tips are used with an inner assembly throughout this disclosure. Piercing tip  608  has a body that extends from a proximal end  609  to a distal end  610 , and may include a bevel  611  at distal end  610  that is configured to pierce through tissue. Piercing tip  608  also may include a flange  612  that extends proximally from bevel  611 . Flange  612  will be described in more detail below. A lumen  613  may extend from proximal end  609  to distal end  610 . Piercing tip  608  may include a circumferential rim  614  at proximal end  609 , and a circumferential flange (not shown) disposed distally of rim  614 , as in embodiments described above. The circumferential flange may have the characteristics and structure of the like-flange described in connection with those other embodiments. Two locking arms  620  extend proximally from rim  614 , 180 degrees apart from each other. Each locking arm  620  includes a radially-outward extending protrusion  621 . Piercing tip  108  also may include a recess  622  at distal end  610 , which may be used in a snap fit engagement with a portion of plug assembly  300 , as discussed in further detail above. Piercing tip  608  also may include one or more openings  624  extending through its body and in communication with lumen  613 , for the same purposes as like-openings described in connection with other embodiments within this disclosure. In an example, piercing tip  608  may include diametrically opposed openings  624  that align with openings  110  of shaft  106 . 
     As shown in  FIGS.  34 - 36   , flange  612  includes two parts  612   a  and  612   b  coupled together by a pivot/hinge  612   c . Parts  612   a ,  612   b  and hinge  612   c  may be constructed as a one-piece, integral structure (for example, molded) or as multiple pieces coupled together by, for example, a pivot pin. If a one piece structure, hinge  612   c  may be a living hinge, permitting pivoting of part  612   a  relative to part  612   b . Piercing tip  608  may be made of any suitable biocompatible material, including bioresorbable materials or materials suitable for a permanent implant. It is contemplated that flange  612  may extend around a greater portion of the circumference of piercing tip  608  than is shown in the figures. For example, flange  612  may extend around a majority of the circumference of piercing tip  608 , or multiple flanges  612  may extend around the circumference of piercing tip  608 . When multiple flanges  612  are utilized, a majority of the circumference of piercing tip  608  may be encompassed by at least one of the flanges  612 . Furthermore, while two parts ( 612   a  and  612   b ) and one hinge ( 612   c ) are shown, a given flange  612  may include additional parts and/or hinges. For example, one flange  612  may include three parts pivotable relative to one another by two hinges. These combinations are only exemplary. Other numbers of parts and flanges also are contemplated. In yet other embodiments, only a minority of the circumference of piercing tip  608  may be covered by a flange  612 . 
     As shown in  FIG.  36   , piercing tip  608  is configured to have a first, insertion configuration suitable for insertion of piercing tip through the blood vessel wall. In that configuration, flange  612  assumes a bent profile, limiting the overall cross-sectional width of tip  608 . In that profile, part  612   a  is pivoted relative to part  612   b , and out of the plane of part  612   b , Part  612   a  assumes a position aligned with the longitudinal axis of the lumen  613  of tip  608 , and adjacent to the outer surface of the body of tip  608 . 
     After insertion of tip  608  within the blood vessel, and pulling back of tip  608 , part  612   a  will snag against the inner surface of the vessel wall, causing part  612   a  to pivot relative to part  612   b  and assume the second implanted configuration shown in  FIGS.  34  and  35   . Flange  612  may be configured so that part  612   a  cannot rotate past the plane of part  612   b , for example by using a living hinge as hinge  612   c . Flange  612 , and particularly its proximal-facing surface, may include a tacky coating and/or bioadhesive to help maintain flange  612  against tissue. 
     Embodiments of the present disclosure may increase the speed of access into the neck for stroke treatments, and also speed up procedural times during other procedures, such as, e.g., femoral access. The angled shape of piercing tip  108  may allow for access into an artery (or other blood vessel) and provide a larger footprint for inside artery securement. 
     Although the exemplary embodiments described above have been disclosed in connection with medical devices for insertion into a blood vessel, those skilled in the art will understand that the principles set out above can be applied to any body lumen and can be implemented in different ways without departing from the scope of the disclosure as defined by the claims. In particular, constructional details, including manufacturing techniques and materials, are well within the understanding of those of skill in the art and have not been set out in any detail here. These and other modifications and variations are well within the scope of the present disclosure and can be envisioned and implemented by those of skill in the art. 
     Other exemplary embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the exemplary embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, and departures in form and detail may be made without departing from the scope and spirit of the present disclosure as defined by the following claims.