Patent Publication Number: US-2022211360-A1

Title: Apparatus and method for sealing a vascular puncture

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 62/623,350, entitled “APPARATUS AND METHOD FOR SEALING A VASCULAR PUNCTURE” and filed on Jan. 20, 2018, which is incorporated herein by reference in its entirety. 
    
    
     FIELD 
     Devices and methods described herein may be useful for sealing a vascular puncture using a plug or sealant. 
     BACKGROUND 
     Some diagnostic or therapeutic procedures require access to a patient&#39;s vaculature (e.g., imaging procedure, angioplasty, stent delivery, or otherwise). A puncture through the patient&#39;s tissue may be created to access the patient&#39;s vasculature percutaneously, i.e., a puncture may be created through the tissue. After completion of the diagnostic or therapeutic procedure, the puncture can be closed by various mechanical or biological solutions, such as by applying external pressure (e.g., manually and/or using sandbags), cinching, suturing, and/or delivering metal implants, plugs, or sealants. However, many of these closure procedures may be time consuming, expensive, and uncomfortable for the patient, requiring the patient to remain immobilized in the operating room, catheter lab, or holding area for extended periods of time. Additionally, some of these prolonged closure procedures may increase the risk of hematoma from bleeding prior to hemostasis. 
     When closing the puncture using a metal implant, plug, sealant, or other appropriate sealing member, the health care professional may use a vascular closure device to position and deploy the sealing member. The device may include a sheath and a support member. The sealant may be positioned inside a sheath or other protective member. The sheath may be moved proximally to expose the sealant in the puncture. The support member may be moved distally to tamp the sealant. However, tamping the sealant prematurely may cause the sealant to become jammed in the sheath. 
     SUMMARY 
     The devices described herein may be used to deploy a sealant in a puncture. These devices may include a sealant sleeve and a support member. During normal operation of the device, the sealant may be initially positioned in a protective member, such as a sealant sleeve. The sealant sleeve may be withdrawn to expose the sealant within the puncture. The support member may be advanced to compress the sealant. It is preferable that at least a portion of the sealant be exposed within the puncture prior to advancing the support member to prevent the sealant from becoming jammed. 
     The devices described herein may include a handle containing a pull rack and a push rack. The sealant sleeve may extend distally from the pull rack. The support member may be a tube, and may extend distally from the push rack. The pull rack and the push rack may interact with other components of the device to control movement of the sealant sleeve and support member. 
     The devices described herein may include a releasable lock to prevent premature advancement of the support member, while allowing advancement of the support member after the sealant has been at least partially exposed. It may be beneficial to decouple distal movement of the support member and disengagement of the lock, such that a distal force applied to the support member does not disengage the lock. For example, in some embodiments, proximal movement of the sealant sleeve may release the lock, thereby allowing the support member to move distally. 
     Another benefit of the devices described herein is their ability to provide a smooth force transition as the lock is disengaged. If the user experiences a sudden increase in force when disengaging the lock, the user may mistakenly believe that they have fully actuated an actuator associated with the sealant sleeve and/or support member, when they may just be experiencing an activation force to disengage the lock from the push rack and/or support member. 
     Another benefit of the devices described herein is the ability to design the device to expose a desired percentage of the sealant before the lock is released, and continue to control the additional distance and rate that the sleeve retracts as the support member is advanced to tamp the sealant. 
     Another benefit of the devices described herein is that the support member and push rack may be substantially unbiased relative to the sealant. In other words, the device does not need a spring to bias the push rack distally. Therefore, disengaging the push rack lock does not necessarily cause the push rack to move distally toward the sealant. An actuator may control distal movement of the push rack, which allows the user to have more control over the timing and speed of advancement of the push rack. In addition, the push rack lock may maintain a locked position, even if the push rack is not biased toward the push rack lock. 
    
    
     
       DESCRIPTION OF THE FIGURES 
         FIG. 1  is a perspective view of a device for delivering a sealant. 
         FIG. 2A  is a perspective view of a pull rack, sealant sleeve, and connector of the device of  FIG. 1 . 
         FIG. 2B  is a side view of the pull rack, sealant sleeve, and connector of  FIG. 2A . 
         FIG. 3  is a perspective view of a push rack and support member of the device of  FIG. 1 . 
         FIG. 4A  is a perspective of a frame of the device of  FIG. 1 . 
         FIG. 4B  is a top view of the frame of  FIG. 4A . 
         FIG. 4C  is a cross-sectional view of the frame of  FIG. 4A . 
         FIG. 5A  is a top view of the device of  FIG. 1  in a locating configuration (the deployment actuator, sheath adapter, and half of the outer housing are not shown). 
         FIG. 5B  is a side view of the device of  FIG. 1  in a locating configuration (the sheath adapter and half of the outer housing are not shown). 
         FIG. 5C  is a cross-sectional view of the distal section of the device of  FIG. 1  in a locating configuration. 
         FIG. 5D  is a cross-sectional view of the distal section of the device of  FIG. 1  in a locating configuration, showing an embodiment of a sealant having a proximal section and a distal section. 
         FIG. 6A  is a top view of the device of  FIG. 1  in a pre-deployment configuration (the deployment actuator, sheath adapter, and half of the outer housing are not shown). 
         FIG. 6B  is a side view of the device of  FIG. 1  in a pre-deployment configuration (the sheath adapter and half of the outer housing are not shown). 
         FIG. 6C  is a cross-sectional view of the distal section of the device of  FIG. 1  in a pre-deployment configuration. 
         FIG. 7A  is a top view of the device of  FIG. 1  in a partially deployed configuration (the deployment actuator, sheath adapter, and half of the outer housing are not shown). 
         FIG. 7B  is a side view of the device of  FIG. 1  in a partially deployed configuration (the sheath adapter and half of the outer housing are not shown). 
         FIG. 7C  is a cross-sectional view of the distal section of the device of  FIG. 1  in a partially deployed configuration. 
         FIG. 8A  is a top view of the device of  FIG. 1  in a fully deployed configuration (the deployment actuator, sheath adapter, and half of the outer housing are not shown). 
         FIG. 8B  is a side view of the device of  FIG. 1  in a fully deployed configuration (the sheath adapter and half of the outer housing are not shown). 
         FIG. 8C  is a cross-sectional view of the distal section of the device of  FIG. 1  in a fully deployed configuration. 
         FIG. 9  is a perspective view of a deployment actuator of the device of  FIG. 1 . 
         FIG. 10  is a perspective view of the device of  FIG. 1  (the outer housing and frame are not shown). 
     
    
    
     DETAILED DESCRIPTION 
     A closure system  1  is illustrated in  FIGS. 1 and 5A-8C . The closure system  1  may comprise a sealant  2  and a device  100  for delivering the sealant  2 . The device  100  may comprise a pull rack  120  and a push rack  140  slidably positioned in an outer housing  112  (also referred to as a handle). The device  100  may also comprise a frame  114  slidably positioned in the outer housing  112 . A sealant sleeve  130  may extend distally from the pull rack  120 . A support member  150  may extend distally from the push rack  140 . The support member  150  may be inserted into the sealant sleeve  130 . The sealant  2  may be positioned in the sealant sleeve  130 , distal to the support member  150 . The device  100  may include a deployment actuator  170  that, when depressed or otherwise actuated, exposes and/or tamps the sealant  2 . The device  100  may include a sheath adapter  106  that allows the device to interface with a procedural sheath. The device  100  may include an elongate member  102  and positioning element  104  to position the device  100  before exposing the sealant  2 . The device  100  may also include a retraction actuator  180  that retracts the positioning element  104  and the elongate member  102  relative to the support member  150  to withdraw the positioning element  104  and the elongate member  102  through the sealant  2 . The device  100  may include various features (described below) to prevent unintended movement of the outer housing  112 , deployment actuator  170 , retraction actuator  180 , pull rack  120 , push rack  140 , and/or frame  114  relative to one another or relative to other components in the device  100 . 
     The device  100  may include a pull rack  120  and a sealant sleeve  130 , shown in  FIGS. 2A-2B . The sealant sleeve  130  may be a tubular member having a proximal section  131 , a distal section  132 , and a lumen  133 . The sealant sleeve  130  may extend along the longitudinal axis  3  of the device  100  as shown in  FIG. 1 . The sealant  2  may be positioned in the lumen  133  of the sealant sleeve  130 , preferably in the distal section  132 . The distal section  132  of the sealant sleeve  130  may be rounded or tapered at the distal end to enclose the sealant  2 . The proximal section  131  of the sealant sleeve  130  may be coupled to the pull rack  120 , such that when the pull rack  120  moves proximally away from the sealant  2 , the sealant sleeve  130  also moves proximally, thereby exposing the sealant  2 . In one exemplary embodiment,  FIGS. 2A-2B  show the sealant sleeve  130  indirectly coupled to the pull rack  120  using a connector  138 . However, the pull rack  120  and sealant sleeve  130  may be integrally formed, directly coupled, or indirectly coupled using various techniques known in the art. The pull rack  120  may be slidably positioned in the outer housing  112 . The pull rack  120  may have an actuating feature  121  (shown as an actuating groove  121  in  FIGS. 2A-2B ) that is engageable with the deployment actuator  170  (described below) and a push rack lock unlocking feature  123  (shown as a wall  123  protruding from the pull rack  120  in  FIGS. 2A-2B ) that is engageable with the push rack lock  160  (described below). 
     The device  100  may include a push rack  140  and a support member  150 , shown in  FIG. 3 . The support member  150  may be a tubular member (and may be referred to as a tamp tube or tamping member). The support member  150  having a proximal section  151 , a distal section  152 , and a lumen  153 . The support member  150  may extend along the longitudinal axis  3  of the device  100  as shown in  FIG. 1 . The distal section  152  of the support member  150  may be slidably positioned in the lumen  133  of the sealant sleeve  130 , proximal to the sealant  2 . The support member  150  may prevent the sealant  2  from moving proximally when the sealant sleeve  130  is withdrawn. The proximal section  151  of the support member  150  may be coupled to the push rack  140 , such that when the push rack  140  moves distally toward the sealant  2 , the support member  150  also moves distally, thereby tamping or compressing the sealant  2 . In an exemplary embodiment,  FIG. 3  shows the push rack  140  directly coupled to the support member  150 . However, the push rack  140  and support member  150  may be integrally formed, directly coupled, or indirectly coupled using various techniques known in the art. The push rack  140  may be slidably positioned in the outer housing  112 . The push rack  140  may have an actuating feature  143  (shown as an actuating ramp  143  in  FIG. 3 ) that is engageable with the deployment actuator  170  and a push rack lock engaging feature  144  (shown as a latch-contacting surface  144  in  FIG. 3 ) that is engageable with the push rack lock  160  (described below). The push rack lock engaging feature  144  may have a distal-facing surface that engages with the push rack lock  160 . 
     The device  100  may include a deployment actuator  170 , shown in  FIG. 9 . The deployment actuator  170  may be actuatable to move the pull rack  120  (and sealant sleeve  130 ) proximally and/or move the push rack  140  (and support member  150 ) distally. The deployment actuator  170  may have a locked position, an unlocked position, a partially actuated position, and a fully actuated position. The deployment actuator  170  may be coupled to the outer housing  112  such that axial movement of the outer housing  112  results in axial movement of the deployment actuator  170 . The deployment actuator  170  may be movable relative to the outer housing  112  upon actuation. 
     The device  100  may include a frame  114 , as shown in  FIGS. 4A-4C . The frame  114  (also referred to as an inner frame) may be positioned inside, and axially movable relative to, the outer housing  112 . The frame  114  may initially engage the pull rack  120  and push rack  140  such that moving the outer housing  112  proximally relative to the frame  114  also moves outer housing  112  proximally relative to the pull rack  120  and push rack  140 . A spring  101 , shown in  FIG. 5B , may be provided in the device  100  to apply a biasing force that biases the frame  114  proximally relative to the outer housing  112  and the deployment actuator  170 , and therefore the spring  101  also applies a biasing force that biases the outer housing  112  and the deployment actuator  170  distally relative to the frame  114 . The frame  114  may include a deployment feature  115  (for example, a slot or a groove) which may be engageable with a portion of the deployment actuator  170 . 
     The deployment actuator  170  is shown as a depressible button in  FIG. 9 , but may alternatively be a slidable button, a lever, a rotating knob, a wheel, or any other actuator that is capable of moving the pull rack  120  proximally and the push rack  140  distally. The deployment actuator  170  may have an actuator locking surface  171  that selectively prevents (or allows) actuation of the deployment actuator  170 . In  FIG. 9 , the actuator locking surface  171  is shown as a pin, but it can be any protrusion or other feature that selectively engages a groove  115  in the frame  114  to selectively allow (or prevent) actuation of the deployment actuator  170 . The deployment actuator  170  may have a pull rack actuating surface  172  that drives the pull rack  120  proximally. In  FIG. 9 , the pull rack actuating surface  172  is shown as a pin that selectively engages a groove  121  in the pull rack  120  to move the pull rack  120  proximally. The deployment actuator  170  may have a push rack actuating surface  173  that drives the push rack  140  distally. In  FIG. 9 , the push rack actuating surface  173  is shown as a wall that selectively engages the actuating ramp  143  on the push rack  140  to move the push rack  140  distally. 
     The deployment actuator  170  may be provided in the locked position, shown in  FIG. 5B , in which actuation of the deployment actuator  170  is prevented. The deployment actuator  170  may contact the frame  114  to prevent actuation. More specifically, the actuator locking surface  171  may rest on a surface of the frame  114  (in other words, the actuator locking surface  171  may be offset from the groove  115  in the frame  114 ), thereby preventing the user from actuating the deployment actuator  170 . The push rack actuating surface  173  of the deployment actuator  170  may be spaced from the actuating ramp  143  on the push rack. 
     When the deployment actuator  170  is in the unlocked position, shown in  FIG. 6B , the deployment actuator  170  may be actuatable. The deployment actuator  170  may be moveable relative to the frame  114 . More specifically, the actuator locking surface  171  may be positioned at an opening of, and may align with, the groove  115  in the frame  114  to allow actuation of the deployment actuator  170 . The push rack actuating surface  173  of the deployment actuator  170  may be spaced from the actuating ramp  143  on the push rack. Compared to their respective positions when the deployment actuator  170  is in the locked position, the outer housing  112  and deployment actuator  170  may be positioned slightly proximally relative to the frame  114 , pull rack  120 , and push rack  140  when the deployment actuator  170  is in the unlocked position. 
     When the deployment actuator  170  is in the partially actuated position (also referred to as a partially depressed position), shown in  FIG. 7B , the actuator locking surface  171  may be positioned in the groove  115  in the frame  114 . The push rack actuating surface  173  of the deployment actuator  170  may be in contact with the actuating ramp  143  on the push rack  140 . As the deployment actuator  170  is actuated, the actuator locking surface  171  may move along the groove  115  in the frame  114 . 
     When the deployment actuator  170  is in the fully actuated position (also referred to as a fully depressed position), shown in  FIG. 8B , the actuator locking surface  171  may be positioned in the groove  115  in the frame  114 . When the deployment actuator  170  is in the fully actuated position, the actuator locking surface  171  may be positioned farther from the opening in the groove  115  in the frame  114  compared to its position when the deployment actuator  170  is in the partially actuated position. The push rack actuating surface  173  of the deployment actuator  170  may be in contact with the actuating ramp  143  on the push rack  140 , and the push rack actuating surface  173  may be positioned farther down the ramp  143  on the push rack  140  compared to its position when the deployment actuator  170  is in the partially actuated position. 
     The device  100  may have a pull rack lock movable between a locked position and an unlocked position. In the locked position, the pull rack lock may engage the pull rack  120  to prevent proximal movement of the pull rack  120 . In the unlocked position, the pull rack lock may be spaced from the pull rack  120 , and the pull rack  120  and sealant sleeve  130  may be proximally movable relative to the outer housing  112 , frame  114 , and/or the pull rack lock to expose the sealant  2 . The pull rack lock may be initially provided in the locked position. Moving the deployment actuator  170  from the locked position to the unlocked position may also move the pull rack lock from the locked position to the unlocked position. In the embodiment shown in  FIG. 9 , the pull rack actuating surface  172  on the deployment actuator  170  may also function as the pull rack lock because the pull rack actuating surface  172  contacts a proximal-facing surface of the pull rack  120  when the deployment actuator  170  is in the locked position, thereby preventing proximal movement of the pull rack. 
     The device  100  may have a push rack lock  160 , shown in  FIGS. 4A-4C , that is deflectable or otherwise movable between a locked position and an unlocked position. The push rack lock  160  may have a push rack engaging portion  164 . In the locked position, shown in  FIGS. 5A-5B , the push rack lock  160  may engage the push rack  140  to prevent distal movement of the push rack  140  and the support member  150 . Specifically, the push rack engaging portion  164  of the push rack lock  160  may contact a latch-contacting surface  144  of the push rack  140 . In the unlocked position, shown in  FIGS. 7A-7B , the push rack lock  160  may be spaced from the push rack  140  such that the push rack  140  and the support member  150  are distally movable relative to the push rack lock  160 . 
     The push rack lock  160  may be initially provided in the locked position to prevent advancement of the support member  150  in the event that distal forces are applied to the push rack  140  prematurely. For example, the push rack lock  160  may be in the locked position during shipping, handling, and preparation of the device  100  in advance of a procedure. The push rack lock  160  may also be in the locked position during the procedure until the sealant  2  is at least partially exposed in the puncture. The push rack lock  160  may be in the locked position when the deployment actuator  170  is in both the locked and unlocked positions. Moving the deployment actuator  170  from the unlocked position to the partially actuated position may also move the push rack lock  160  from the locked position to the unlocked position. The push rack lock  160  may be in the unlocked position when the deployment actuator  170  is in the partially actuated position. 
     When the push rack lock  160  is in the locked position, it may preferably remain in the locked position upon axial movement of the push rack  140  (or upon application of axial forces to the push rack  140 ). A push rack lock unlocking feature  123 , shown in  FIG. 2A , may be movable relative to the push rack  140  and the push rack lock  160  to move the push rack lock  160  from the locked position to the unlocked position. Axial (and preferably proximal) movement of the push rack lock unlocking feature  123  may cause lateral movement of a portion of the push rack lock  160 . Lateral movement of a portion of the push rack lock  160  may unlock the push rack lock  160 , thereby allowing axial (and preferably distal) movement of the push rack  140 . In the embodiment shown in  FIGS. 6A-7B , the push rack lock unlocking feature  123  is included on the pull rack  120  such that proximal movement of the pull rack  120  may unlock the push rack lock  160 . When the push rack lock  160  is in the locked position, the pull rack  120  may be movable proximally relative to the push rack  140  and the push rack lock  160 . When the push rack lock  160  is in the unlocked position, the pull rack  120  and the push rack  140  may both be axially movable relative to the push rack lock  160 . Instead of being included on the pull rack  120 , the push rack lock unlocking feature  123  may be included on another component, including the deployment actuator  170 , outer housing  112 , and/or frame  114 . The push rack lock  160  may move from the locked position to the unlocked position upon actuation of the deployment actuator  170  and/or movement of the frame  114  relative to the outer housing  112 . The device  100  may include a feature that prevents or limits premature movement of the push rack lock unlocking feature  123 . For example, the pull rack  120  may have a pull rack lock provided in a locked position, the deployment actuator  170  may be provided in a locked position, and/or the spring  101  may limit movement of the frame  114  relative to the outer housing  112 . 
     The push rack  140  and the support member  150  may be substantially unbiased in the axial direction, and more specifically, may be substantially unbiased relative to the sealant  2 . Therefore, moving the push rack lock  160  from the locked position to the unlocked position does not automatically cause the push rack  140  to move distally toward the sealant  2 . The push rack  140  may be able to maintain the same position before and after the push rack lock  160  is unlocked, until the deployment actuator  170  begins moving from a partially actuated position to a fully actuated position to advance the push rack  140 . After the push rack lock  160  is moved from the locked position to the unlocked position, further movement of the deployment actuator  170  may move the push rack  140  distally. 
     The push rack lock  160  may be integrally formed with (or coupled to) various components of the device  100 , including but not limited to the outer housing  112 , the frame  114 , the deployment actuator  170 , or other components of the device  100 . In one embodiment shown in  FIG. 4A , the push rack lock  160  is integrally formed with the frame  114 . 
     In the embodiment shown in  FIGS. 4A-4C , the push rack lock  160  may comprise a pull rack engaging portion  163  (shown as an arm  163  in  FIGS. 4A-4C ) and a push rack engaging portion  164  (shown as a latch  164  near one end of the arm  163  in  FIGS. 4A-4C ). The latch-contacting surface  144  on the push rack  140  may be a protrusion, as shown in  FIG. 3 . When the push rack lock  160  is in the locked position, as shown in  FIGS. 5A-5B , the latch-contacting surface  144  of the push rack  140  may engage the latch  164  to prevent distal movement of the push rack  140 . The push rack lock  160  may be deflected from the locked position to the unlocked position. When the push rack lock  160  is in the unlocked position, as shown in  FIGS. 7A-7B , the latch-contacting surface  144  of the push rack  140  may be spaced or disengaged from the latch  164 , allowing the push rack  140  to move distally relative to the latch  164 . To unlock the push rack lock  160 , the wall  123  on the pull rack  120  may slide along the arm  163  of the push rack lock  160 , which may deflect the arm  163  and cause the latch  164  to move laterally and become spaced or disengaged from the latch-contacting surface  144  of the push rack  140 . The latch  164  may contact at least a distal-facing surface of the latch-contacting surface  144  on the push rack  140 . The latch  164  may also contact additional surfaces of the push rack  140 . For example, the latch  164  may also contact a top-facing surface and/or a bottom-facing surface of the latch-contacting surface  144  on the push rack  140  to further limit movement of the latch  164  to a single direction, preferably a direction that is substantially perpendicular to the longitudinal axis  3  of the device  100  (also referred to as a radial direction or a lateral direction). In an exemplary embodiment shown in  FIG. 5B , the latch  164  may comprise a u-shaped groove or slot having an opening at the proximal end of the slot such that movement of the latch  164  is limited to the radial direction when the latch  164  engages the latch-contacting surface  144 . 
     During use, actuating the deployment actuator  170  may cause the pull rack  120  to move proximally and unlock the push rack lock  160 . One benefit of the devices described herein is a gradual increase in the actuation force of the deployment actuator  170  while unlocking the push rack lock  160 . The angle θ of the arm  163  of the push rack lock  160  (see  FIG. 4B ) may ensure a gradual increase in the actuation force. The angle θ of the arm  163  may be measured from a plane extending through the longitudinal axis  3 , and may be less than about 60°. In another embodiment, the angle θ may be less than about 45°, less than about 40°, less than about 35°, less than about 30°, less than about 25°, or less than about 20°. In another aspect, the angle θ of the arm  163  may be between about 10° and about 60°, between about 20° and about 45°, between about 25° and about 40°, between about 30° and about 40°, or between about 32° and about 36°. In one embodiment, the angle θ of the arm  163  of the push rack lock  160  may be about 34°. 
     If the angle θ of the arm  163  is too high, the user may experience a sudden increase in the actuation force of the deployment actuator  170  as the pull rack  120  moves proximally and the push rack lock  160  moves to the unlocked position. However, if the angle θ of the arm  163  is too low, it may not provide enough resistance to prevent premature advancement of the push rack  140  if a proximal force is applied to the pull rack  120 . Therefore, the device may include a feature that prevents or limits premature movement of the push rack lock unlocking feature  123  (as discussed above) to minimize the risk of prematurely unlocking the push rack lock  160  without creating an excessively high actuation force of the deployment actuator  170 . For example, if the push rack lock unlocking feature  123  is provided on the pull rack  120 , then the pull rack lock also limits or prevents premature movement of the push rack lock unlocking feature  123 . The actuation force of the deployment actuator  170  may be between about 5N and about 40N. In another aspect, the actuation force may be between about 10 N and about 30 N, or between about 15 N and about 20 N. 
     The device  100  may also have a feature to position the sealant  2  in the puncture. For example, the device  100  may include an elongate member  102  coupled to the frame  114 . The elongate member  102 , shown in  FIG. 5C , may extend along the longitudinal axis  3  of the device  100  shown in  FIG. 1 . The elongate member  102  may extend through the lumen  153  of the support member  150  and a lumen of the sealant  2 . A radially-expandable positioning element  104  (including but not limited to a balloon, wire mesh, or foot plate, for example) may be provided on a distal section of the elongate member  102 . The proximal end of the positioning element  104  may be connected to the elongate member  102 , and the distal end of the positioning element  104  may be connected to a core wire  103 , as shown in  FIG. 5C . The core wire  103  may extend along the longitudinal axis  3  of the device  100 , in a lumen of the elongate member  102 , and may move axially as the positioning element  104  moves between the radially-expanded configuration and the radially-contracted configuration. The positioning element  104  may be inserted into the vessel in a radially-contracted configuration. When the positioning element  104  is in the vessel, it may be moved to a radially-expanded configuration and the device  100  may be withdrawn proximally until the positioning element  104  contacts the vessel wall, which may provide tactile confirmation that the device has been positioned properly. If the positioning element  104  is a balloon, the balloon may be moved to the radially-expanded configuration by inflating the balloon. Moving the positioning element  104  to the radially-expanded configuration may also move the core wire  103  proximally relative to the elongate member  102 . Once the positioning element  104  contacts the vessel wall, continuing to apply a proximal force to the outer housing  112  may compress the spring  101 , move the outer housing  112  (and the deployment actuator  170 ) proximally relative to the frame  114 , and apply tension to the frame  114  and/or elongate member  102 . Moving the deployment actuator  170  relative to the frame  114  may move the deployment actuator  170  to the unlocked position, thereby allowing deployment of the sealant  2 . After the sealant  2  is deployed, the positioning element  104  may be moved to the radially-contracted configuration and the device  100  may be withdrawn from the puncture. If the positioning element  104  is a balloon, the balloon may be moved to the radially-contracted configuration by deflating the balloon. 
     The device  100  may also include a positioning element indicator  190 , shown in  FIG. 10 . The positioning element indicator  190  may have a first position that provides a visual indication that the positioning element  104  is in a radially-contracted configuration. The positioning element indicator  190  may have a second position that provides a visual indication that the positioning element  104  is in a radially-expanded configuration. The positioning element indicator  190  may be coupled to the core wire  103 , such that axial movement of the core wire  103  also moves the positioning element indicator  190  axially between the first and second positions. 
     An exemplary embodiment of the sealant  2  is shown in  FIGS. 5C, 6C, 7C, and 8C , and may comprise known materials used for sealing punctures, including but not limited to collagen, freeze-dried hydrogels, non-cross-linked hydrogel precursors, chitosan, and combinations thereof. A lumen may extend through the sealant  2 . The sealant  2  may be positioned in the distal section  132  of the sealant sleeve  130 , radially between the elongate member  102  and the sealant sleeve  130 . For example, the elongate member  102  may extend through the lumen of the sealant  2 , and the sealant sleeve  130  may surround the sealant  2 . The support member  150  may be proximal to the sealant  2 , such that a distal surface of the support member  150  may contact the sealant  2 .  FIG. 5D  shows the same device having an alternative embodiment of a sealant. The sealant of  FIG. 5D  may include a proximal section  2 a formed from freeze-dried hydrogel, and a distal section  2 b formed from a plurality of non-freeze-dried and/or non-cross-linked precursors. The distal section  2 b may face or contact the positioning element  104 . 
       FIGS. 5A-8C  show an exemplary method for deploying the sealant  2  in a puncture. The device  100  may be provided in a resting configuration. The device  100  is not shown in the resting configuration in  FIGS. 5A-8C ; however, the resting configuration is similar to the locating configuration shown in  FIGS. 5A-5C , except the positioning element  104  may be in a radially-contracted configuration when the device is in the resting configuration. The deployment actuator  170 , pull rack lock and/or push rack lock  160  may be in their respective locked positions. The pull rack actuating surface  172 , shown in  FIG. 9 , may function as a pull rack lock, and may contact a stop  122  on the pull rack  120  shown in  FIG. 2A  and/or may be offset from the opening  125  in the groove  121  in the pull rack  120  to prevent proximal movement of the pull rack  120 . The push rack lock  160  may engage the push rack  140  to prevent distal movement of the push rack  140 . The push rack  140  may be spaced or disengaged from the deployment actuator  170 . When the device  100  is in the resting configuration, the positioning element indicator  190  may be in the first position, indicating that the positioning element  104  is in a radially-contracted configuration. 
     The distal end of the device  100  may be inserted into the puncture while the device  100  is in the resting configuration. When the positioning element  104  is in the vessel, the positioning element  104  may be moved to the radially-expanded configuration, bringing the device to a locating configuration, shown in  FIGS. 5A-5C . The positioning element indicator  190  may move to the second position, indicating that positioning element  104  is in the radially-expanded configuration. The device  100  may be withdrawn proximally until the expanded positioning element  104  contacts the vessel wall. 
     Once the positioning element  104  contacts the vessel wall, continuing to withdraw the device  100  may move the device  100  from the locating configuration to a pre-deployment configuration. In the embodiment shown in  FIGS. 5B and 6B , continuing to withdraw the outer housing  112  may move the device  100  from the locating configuration to the pre-deployment configuration by compressing the spring  101  and applying tension to the frame  114  and/or elongate member  102 . Tension may be applied when the vessel wall applies a distal force to the frame  114  and elongate member  102  (via the positioning element  104 ) while the spring  101  applies a proximal force to the frame  114  and elongate member  102 . The deployment actuator  170  and/or the pull rack lock may move from their respective locked positions to their respective unlocked positions. The push rack lock  160  may remain in the locked position. The deployment actuator  170  (together with the outer housing  112 ) may move proximally relative to the frame  114 , pull rack  120 , and push rack  140 . The device  100  may include a tension indicator, which can indicate that an appropriate amount of tension is being applied to the frame  114 , and also indicate that the device  100  is in the pre-deployment configuration. An exemplary tension indicator  105 , shown in  FIG. 1 , may comprise a marking on the frame  114  that aligns with markings adjacent a window in the outer housing  112  to indicate that the frame  114  is under tension, however any other appropriate tension indicator can be used that provides a similar function. Therefore, the device  100  in  FIG. 1  is in the pre-deployment configuration because the frame  114  and/or elongate member  102  is under tension and the deployment actuator  170  has not been actuated. 
     When the device  100  is in the pre-deployment configuration, shown in  FIGS. 6A-6C , the deployment actuator  170  and/or the pull rack lock may be in their respective unlocked positions. The push rack lock  160  may be in the locked position. The pull rack actuating surface  172  of the deployment actuator  170  may align with an opening  125  in a groove  121  in the pull rack  120 , allowing for proximal movement of the pull rack  120 . The push rack  140  may be spaced from the deployment actuator  170 . Compared to their respective positions when the device is in the resting and locating configurations, the outer housing  112  and deployment actuator  170  may be positioned slightly proximally relative to the frame  114 , pull rack  120 , and push rack  140  when the device is in the pre-deployment configuration. The position of the frame  114 , pull rack  120 , and push rack  140  relative to one another may be substantially the same when the device  100  is in the resting, locating, and pre-deployment configurations. 
     The device  100  may be moved from the pre-deployment configuration to the partially deployed configuration, preferably by moving the deployment actuator  170  from the unlocked position to the partially actuated position. Moving the device  100  from the pre-deployment configuration to the partially deployed configuration may move the pull rack  120  and the sealant sleeve  130  proximally to expose at least a portion of the sealant  2 . The pull rack actuating surface  172  may move into and slide along at least part of the groove  121  in the pull rack  120 . Moving the device  100  from the pre-deployment configuration to the partially deployed configuration may move the push rack actuating surface  173  of the deployment actuator  170  toward the push rack  140 , and may move the push rack lock  160  from the locked position to an unlocked position. The push rack  140  and the support member  150  may remain substantially stationary relative to the push rack lock  160  when the device  100  is moved from the pre-deployment configuration to the partially deployed configuration. A distal surface of the support member  150  may contact the sealant  2 , such that the support member  150  prevents proximal movement of the sealant  2  and maintains the position of the sealant  2  as the sealant sleeve  130  is retracted, thereby exposing the sealant  2 . 
     When the device  100  is in the partially deployed configuration, shown in  FIGS. 7A-7C , the sealant sleeve  130  may be at least partially retracted and the sealant  2  may be at least partially exposed. The deployment actuator  170  may be in the partially actuated position. The pull rack actuating surface  172  may be positioned in the groove  121  in the pull rack  120 . The pull rack  120  may be positioned proximally compared to its position when the device  100  is in the pre-deployment configuration, such that the pull rack  120  and sealant sleeve  130  are at least partially retracted. The push rack lock  160  may be in an unlocked position, such that the push rack lock  160  is spaced from the push rack  140 . The deployment actuator  170  may now engage the push rack  140 , although the position axial position of push rack  140  relative to the frame  114  and/or push rack lock  160  may be substantially the same when the device  100  is in the pre-deployment configuration and the partially deployed configuration. Specifically, the push rack actuating surface  173  of the deployment actuator  170  may contact the actuating ramp  143  on the push rack  140 . 
     The device  100  may then be moved from the partially deployed configuration to the fully deployed configuration, preferably by moving the deployment actuator  170  from the partially actuated position to the fully actuated position. The push rack  140  may move distally and the support member  150  may move to a fully advanced position. Specifically, the push rack actuating surface  173  of the deployment actuator  170  may slide along the actuating ramp  143  and move the push rack  140  distally. The pull rack  120  and sealant sleeve  130  may move proximally to the fully retracted position, or they may remain in the fully retracted position if they were fully retracted in the partially deployed configuration. 
     When the device  100  is in the fully deployed configuration, shown in  FIG. 8A-8C , the sealant  2  may be exposed and compressed (or tamped) in the puncture. The deployment actuator  170  may be in a fully actuated position. The pull rack  120  may be positioned either in the same position or proximal to its position when the device  100  is in a partially deployed configuration, such that the pull rack  120  and sealant sleeve  130  are retracted from the sealant  2  and the sealant  2  is exposed in the puncture. The push rack  140  may be moved distally relative to the frame  114  and/or push rack lock  160  compared to their respective positions when the device  100  is in the partially deployed configuration, such that the push rack  140  and support member  150  are advanced toward the sealant  2  and the sealant  2  is tamped. 
     After the sealant  2  is exposed and compressed, the device  100  may be withdrawn from the puncture. The retraction actuator  180 , shown in  FIGS. 1 and 10 , may be actuated to retract the positioning element  104 , elongate member  102 , and core wire  103  relative to the support member  150 , such that the positioning element  104  may be withdrawn through the sealant  2  while the support member  150  prevents the sealant  2  from moving proximally. The retraction actuator  180  may cause the elongate member  102  and core wire  103  to slide proximally. Alternatively, the retraction actuator  180  may bend or kink the elongate member  102  and core wire  103 , causing the distal ends of the elongate member  102  and core wire  103  to move proximally. 
     One or more lockout mechanisms may prevent the user from prematurely depressing the retraction actuator  180 . First, the push rack  140  may include a first retraction actuator locking surface  145 , shown in  FIG. 10 , that prevents the retraction actuator  180  from being actuated before the sealant  2  has been tamped. When the device  100  is in the resting, locating, pre-deployment, and partially deployed configurations, the first retraction actuator locking surface  145  may contact the retraction actuator  180  to prevent actuation of the retraction actuator  180 . When the push rack  140  moves distally and the device  100  is in the fully deployed configuration, the first retraction actuator locking surface  145  may be spaced from the retraction actuator  180  to allow actuation of the retraction actuator  180 . Second, the positioning element indicator  190  may include a second retraction actuator locking surface  191 , also shown in  FIG. 10 . When the positioning element indicator  190  is in the second position and the positioning element  104  is in the radially-expanded configuration, the second retraction actuator locking surface  191  may contact the retraction actuator  180  to prevent actuation of the retraction actuator  180 . When the positioning element indicator  190  is in the first position and the positioning element  104  is in the radially-contracted configuration, the second retraction actuator locking surface  191  may be spaced from the retraction actuator  180  to allow actuation of the retraction actuator  180 . Therefore, the retraction actuator  180  may be actuated after the sealant  2  has been tamped and the positioning element  104  has been returned to the radially-contracted configuration. Once the retraction actuator  180  has been actuated and the positioning element  104  has been retracted through the sealant  2 , the device  100  may be withdrawn from the puncture. 
     As used herein, the relative terms “proximal” and “distal” shall be defined from the perspective of the closure system. Thus, proximal refers to the direction of the handle of the closure system and distal refers to the direction of the distal tip of the closure system. The term “axial” refers to a direction parallel to the longitudinal axis of the device. The terms “radial” and “lateral” refer to a direction lying in a plane perpendicular to the longitudinal axis of the device. The terms “retracting” and “withdrawing” indicate proximal movement, and the term “advancing” indicates distal movement. 
     Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “tamping the sealant” include “instructing tamping of the sealant.” 
     Although certain embodiments and examples have been described herein, it will be understood by those skilled in the art that many aspects of the closure system shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable. 
     Some embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps. 
     For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. 
     Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and/or inserting additional actions and/or deleting actions. It is intended, therefore, that the specification and examples be considered as illustrative only, with a true scope and spirit being indicated by the claims and their full scope of equivalents.