50 may be configured to retract the footplate 40 in a proximal direction. The retraction assembly 50 may include a tether 52 coupled to the footplate 40 and the guide member 15 engaged with the footplate 40.

The tether 52 may be or comprise any elongated element coupled to the footplate 40. As such, the tether may be an elongated shaft, suture, filament, wire, or rod. In some examples, the tether 52 may resemble a rip cord in form and/or function, such that pulling the tether 52 proximally may abort, in effect, the deployment of a sealing unit 18 in the event one or more components of which, such as footplate 40, are improperly positioned. In the embodiment shown, the tether 52 extends through the deployment assembly 14. However, in some configurations, the tether may extend alongside the deployment assembly 14. The retraction assembly may also include a retraction actuator 47 configured to pull the tether 52 in a proximal direction in order to retract at least the footplate 40 in a proximal direction that is opposite a distal direction. In one example, the actuator 47 may be a push-pull member, which may include a rod and wire. In another example, the actuator 47 may be a rotatable knob, rotatable lever, or a slide. Proximal pulling of the tether 52, and thus footplate 40, may be prompted by a user in response to a determination that the footplate is not positioned correctly in or near an inner vessel wall. In this manner, the tether 52 may provide a bailout mechanism for retracting the footplate during a procedure.

As shown in FIG. 5, the guide member 15 may have an elongate body 60 having proximal end 62, a distal end 64, and a lumen 66 that extends from the proximal end 62 to the distal end 64. The lumen 66 is configured to receive a guidewire therethrough, such as guidewire 150 (see FIGS. 6-10). The guide member 15 may also include footplate engagement member 68 configured to abut the footplate 40. The guide member 15 may also include an advancement engagement member 70 configured to, when a force is applied to the advancement engagement member 70, advance the guide member 15 in the distal direction. The guide member 15 may also include an actuator 76, which may be configured as a grip member, which in some examples may be manually engageable by a user.

After deployment of the footplate 40, abutment of the footplate engagement member 68 against the footplate 40 may cause the footplate 40 to pivot for retraction in the proximal direction. More specifically, retraction of the tether 52 and advancement of the guide member 15 in a distal direction until the footplate engagement member 68 abuts the proximal surface of the footplate 44 may cause the footplate 40 to pivot for retraction in a proximal direction.

In operation, the deployment assembly 14 may be initially configured to insert the footplate 40 into the vessel. When the deployment actuator 38 is actuated, the release component 22 may move in the proximal direction 4 relative to the delivery component 26 into the releasing position, thereby releasing the proximal end 41p of the footplate 40 from between the release component 22 and the delivery component 26. As the release component 22 moves in the proximal direction 4, the suture 44 may be pulled in the proximal direction 4 to thereby place the suture 44 in tension and urge the footplate 40 against the distal end of the delivery component 26. At this point, the footplate 40 may be oriented in the sealing position (see FIGS. 11 and 12, for example). Accordingly, the release component 22 may be configured to restrain the footplate 40 of the sealing unit 18 during insertion of the vascular closure device 10 into the vessel and subsequently release the footplate 40 so that the footplate 40 can be oriented for the scaling procedure.

In certain cases, the user may need to reposition the footplate 40. In this situation, the user can determine a position of the footplate 40 in the lumen of the artery or vein using typical visualization procedures, such a puncture locators, radiography, or other means to identify the location of the footplate. The user can retract the footplate 40 in a proximal direction toward the distal end of the deployment assembly and out of the lumen of the artery or vein. In this instance, retracting the footplate 40 in the proximal direction may further comprise retracting a tether (e.g., tether 52) coupled to the footplate. In addition, the user can advance the footplate engagement member 68 of a guide member (e.g., guide member 15) against a proximal surface of the footplate 40, thereby causing the footplate 40 to pivot for retraction in the proximal direction. The footplate can be retracted back toward or into the delivery assembly. In certain instances, the user may cause the plug 88 to exit out of the deployment assembly and then cause retraction of the sealing plug 88 back toward the distal end of the deployment assembly. In any event, after retracting the footplate 40 in the proximal direction, the user can readvance the footplate 40 in the distal direction toward the lumen of the artery or vein into the correct position.

Embodiments of the present technology will now be described with respect to exemplary large bore procedures that utilize the vascular closure device 10. In order to perform any of the related procedures, the user gains percutaneous access to, for example, the femoral artery, causing a puncture site in the artery. To gain percutaneous access to the artery, the Seldinger technique may be used. For example, a hollow bore needle may be inserted into the artery. A guidewire 150 may then be advanced through the hollow needle and into the femoral artery a sufficient distance to allow removal of the needle without the guidewire 150 pulling out of the vessel. Removing the needle leaves the guidewire 150 in place, with a portion of the guidewire 150 extending into the artery. The guidewire 150, extending from outside the patient into the femoral artery, provides for an entry guide for other medical devices, including the vascular closure device 10. Therefore, once the guidewire 150 is positioned in the vessel of the patient, catheters or introducers of gradually increasing diameters may be advanced over the guidewire 150 and through the puncture into the artery to further open the puncture site. Then, an introducer/procedure access sheath set (i.e. an introducer inside an access tube or sheath) may be moved along the guidewire 150 such that a distal end of the sheath moves into the vessel through the puncture site. Once properly positioned, the introducer can be removed such that the sheath provides for sizable access to the vessel interior from outside the body.

After the relevant procedure is completed, the puncture site in the artery created by the bore needle during percutaneous access of the artery may be closed. The vascular closure device 10 may be used to seal the puncture site. FIGS. 6-16 show schematic views of the vascular closure device 10 during the process of closing a puncture site 200 in a vessel (e.g. artery) wall 204.

Now in reference to FIG. 6, to deliver the vascular closure device 10 to the puncture site 200 so that the closure device 10 can seal the puncture site 200, the introducer/procedure sheath set or assembly may be replaced with a closure access sheath 208. For example, as shown in FIG. 6, the procedure sheath is exchanged for the closure access sheath 208 by removing the procedure sheath from the patient, leaving the guidewire 150 in place, and subsequently moving the closure access sheath 208 along the guidewire 150 or otherwise positioning the access sheath 208, such that a portion of the access sheath 208 is disposed within the vessel through the puncture site 200. As shown in FIG. 6, the access sheath 208 may define a distal end D_A, a proximal end P_A, and an internal access channel 212 that extends from the proximal end P_Ato the distal end DA along an insertion direction I. The access sheath 208 may further include a sheath hub 216 at its proximal end P_A. The sheath hub 216 may be configured to couple to the vascular closure device 10 when the vascular closure device 10 is inserted into the access channel 212 along the insertion direction I.

As shown in FIG. 7, the vascular closure device 10 can be positioned by translating, extending, or otherwise advancing the vascular closure device 10 into and through the access channel 212 along the insertion direction I, such that a portion of the footplate 40 (e.g. distal portion 41d) may protrude from the distal end D_Aof the access sheath 208 and into the vessel. Once fully inserted, the vascular closure device 10 can couple to the sheath hub 216. A proximal end of the footplate 40 may be coupled to the release component 22 and the delivery component 26 while the vascular closure device 10 is being moved into the vessel through the puncture site 200 of the vessel. While the proximal end of the footplate 40 is fixed, the footplate 40 may be oriented in a pre-sealing position whereby at least the proximal end of the footplate 40 is concealed and thus prevented from dragging against the vessel wall during positioning of the footplate 40 within the vessel.

Once the vascular closure device 10 is properly positioned within the access sheath 208, the footplate 40, and in particular, the entire access sheath 208 and vascular closure device 10 combination, can be moved proximally such that the footplate 40 is positioned adjacent to the puncture site 200, as shown in FIGS. 6-8. As noted above, in some cases the footplate 40 may not be in the proper position for sealing after its insertion in a target vessel. In this situation, the user can determine a position of the footplate 40. As shown in FIGS. 9 and 10, the user can retract the footplate 40 in a proximal direction toward the distal end of the deployment assembly 14 and even out of the lumen of the artery or vein in some examples. In this instance, retracting the footplate in the proximal direction further comprises retracting a tether 52 coupled to the footplate 40. In addition, the user can advance the footplate engagement member of a guide member against a proximal surface of the footplate, thereby causing the footplate 40 to pivot for retraction in the proximal direction, as shown in FIG. 10. The footplate 40 can be retracted back toward or into the delivery assembly 10. After retracting the footplate in the proximal direction, the use can readvance the footplate 40 in the distal direction toward the lumen of the artery or vein into the correct position, as shown in the progression from FIGS. 10 to 11.

Once the footplate 40 is adjusted to a proper position, the deployment actuator 38 may be actuated to release the footplate 40 from the release tube and subsequently apply a tension to the suture 44 so as to pull the footplate 40 against the distal end of the delivery component 26, as shown in FIG. 11. At this point the footplate 40 may be oriented in a scaling position.

With the footplate 40 in the sealing position, the deployment assembly 14 along with the access sheath 208 can together be pulled proximally such that the footplate 40 abuts the vessel wall 204, as shown in FIG. 12. As shown in FIG. 13, further pulling of the device 14 and sheath 208 may cause the sealing unit 18, including the footplate 40, plug 88, locking member 230, suture 44, and a tamper 234, to be fully withdrawn from the delivery component 26. By pulling on the suture 44 in a direction away from the vessel (i.e. in a direction opposite the insertion direction I) the suture 44 may be tensioned and the footplate 40 moved fully into position against an inner surface of the vessel wall 204 at the puncture site 200. The tension in the suture 44 may also pull the plug 88 into the puncture site 200, and may cause the plug 88 to substantially fill the puncture site 200, as shown for instance in FIG. 14. After the plug 88 is in contact with blood or other fluids within the puncture site 200, the plug 88 may expand and fill the remainder of the puncture site 200.

After the user has pulled the suture 44 to cause tension in the suture 44 and to cause the plug 88 to enter the puncture site 200, the user may advance the tamper 234 distally along the guidewire 150 and the suture 44. As shown in FIG. 15, the tamper 234 may contact the locking member 230 and advance the locking member 230 distally along the suture 44 until the locking member 230 contacts the plug 88 and presses the plug 88 against an outer surface of the vessel. As the plug 88 is compressed by the tamper 234 and locking member 230, the plug 88 may fold over the top of and inside the puncture site 200. It should be appreciated, however, that in some embodiments, the delivery component 26 may be pulled such that the plug 88 is removed from the delivery component 26 within the release component 22, and the tamper 234 may be employed within the release component 22. In such an embodiment, the release component 22 may help control the plug 88 as it is being tamped against the puncture site.

As further shown in FIGS. 15 and 16, the locking member 230, together with the plug 88 and the footplate 40, may effect a seal of the puncture site 200. Tension may be maintained on the suture 44 throughout the deployment of the plug 88 from the delivery component 26. After the puncture site 200 is sealed, the guidewire 150 can be removed as shown in FIG. 15. As the guidewire