Patent Description:
The present disclosure relates to vascular closure system with an introducer configured for sheath transfer.

During an interventional cardiovascular procedure a puncture may be made in the femoral artery. Advanced cardiovascular procedures may obtain access to the aorta via the vena cava in situations where the femoral artery is not a suitable approach path. In one example, the procedure is a trans-caval aortic valve replacement procedure, or "trans-caval" procedure. Vascular closure devices composed of an absorbable intra-arterial toggle, an extra-vascular folding sealing plug, and a connecting suture, such as a filament, have been developed and may be used to seal these punctures. These devices function by compressing the intra and extraarterial components together around the puncture, with sufficient tension within the connecting suture. However, as the size of percutaneous sheaths become larger to accommodate larger cardiovascular devices, the size of the resulting puncture increases. Larger punctures are harder to seal because of the larger vessel wall defect or puncture. In the case of sealing blood pressure with an external plug, larger defects expose the plug to increased forces, which must be supported through the connecting suture by the intra-arterial toggle. <CIT> describes a vascular closure device and an introducer/procedure access sheath for use with the device. The vascular closure device including a release component, a delivery component, a sealing device and at least one actuator. The release component is elongate along a longitudinal direction, and defines a distal end and a proximal end. The delivery component extends along the release component such that at least the release component is movable relative to the delivery component. The delivery component includes a delivery tube body and defines a delivery tube channel. The sealing device has a toggle that is at least partially disposed within the release tube, a suture that is attached to the toggle and extends through the delivery tube channel, and a plug that is attached to the suture proximal to the toggle. The actuator is coupled to the release component and is in communication with the suture such that actuation of the actuator causes (i) the release component to move the proximal direction relative to the delivery component so as to release the toggle from the release component, and (ii) the suture to be pulled in a proximal direction to thereby place the filament in tension and urge the toggle against a distal end of the delivery component such that the toggle is oriented in a sealing position. <CIT> describes an apparatus for delivering a closure element, including an introducer sheath, a locator and an actuator assembly. <CIT> discloses systems and methods for closing vascular access ports.

An embodiment of the present disclosure is a system configured to seal a puncture in a vessel according to claim <NUM>. Optional features are defined in the dependent claims.

The use of the introducer limits blood loss during an exchange of a procedure access sheath used to guide a catheter (or other medical device) into the vessel, e.g. the femoral artery or the aorta, with an access sheath for use with a vascular closure device.

The foregoing summary, as well as the following detailed description of an exemplary embodiments of the application, is better understood when read in conjunction with the appended figures. The figures illustrate exemplary embodiments for the purposes of illustration. It should be understood, however, that the application is not limited to the precise arrangements and systems shown.

Certain terminology is used in the following description for convenience only and is not limiting. The words "right", "left", "lower" and "upper" designate directions in the drawings to which reference is made. The words "proximally" and "distally" refer to directions toward and away from, respectively, the individual operating the system. The terminology includes the above-listed words, derivatives thereof and words of similar import.

Referring to <FIG>, the vascular closure system <NUM> includes an introducer <NUM> and a closure device <NUM> that is configured to seal the puncture in a vessel wall. The introducer <NUM> is configured to facilitate placement of the closure device <NUM> into the desired position within a puncture site of a vessel wall following a surgical procedure. The closure device <NUM> includes a deployment assembly <NUM> and an access sheath <NUM>. The access sheath <NUM> can be inserted into the vessel and the deployment assembly <NUM> can be inserted into the access sheath <NUM> to position a sealing device or implantable unit <NUM> (<FIG>) into the vessel. The access sheath <NUM> and introducer <NUM> can be referred to as insertion assembly <NUM>.

<FIG> illustrates the embodiments of an introducer <NUM>. The introducer <NUM> is configured to be inserted through the puncture along a guidewire <NUM> (<FIG>) that extends through the puncture into the vessel. The introducer <NUM> includes an introducer body <NUM> that is elongate along a central axis <NUM>, a proximal tapered tip <NUM> a distal tapered tip <NUM> that is opposite to the proximal tapered tip <NUM> along the central axis <NUM>, and a bore <NUM> that extends from the proximal tapered tip <NUM> to the distal tapered tip <NUM> along the central axis <NUM>. The bore is sized to receive the guidewire <NUM> (not shown) therethrough. The distal tapered tip of the introducer is configured to be inserted into the vessel along the guidewire <NUM>.

In one embodiment as shown in <FIG>, the introducer <NUM> includes a proximal component <NUM> that defines the proximal tapered tip <NUM>, and a distal component <NUM> that defines the distal tapered tip <NUM>. The proximal component <NUM> and the distal component <NUM> are configured to be coupled together to define the introducer body <NUM> of the introducer. The proximal component defines a proximal portion of the bore <NUM>. The distal component defines a distal portion of the bore <NUM> that is aligned with the proximal portion of the bore when the proximal and distal components are coupled together.

The introducer body <NUM> defines an outer surface <NUM> and outer cross-sectional dimension C that is perpendicular to the central axis <NUM>. As illustrated, the outer cross-sectional dimension C does not vary along an entirety of the introducer body <NUM> between the proximal tapered tip <NUM> and the distal tapered tip <NUM>. The proximal tapered tip <NUM> tapers from the outer surface <NUM> toward the central axis <NUM> along a proximal direction <NUM> away from the distal tapered tip <NUM>. Furthermore, the distal tapered tip <NUM> tapers from the outer surface <NUM> toward the central axis <NUM> along a distal direction <NUM> that is opposite to the proximal direction <NUM>. The introducer <NUM>(or introducer body <NUM>) is configured to be inserted through the front end 21f and into the lumen of access sheath <NUM> such that a movable interference fit is attained between the access sheath <NUM> and the introducer <NUM>. A moveable interference fit is where the introducer can be inserted into the access sheath <NUM> so as to permit the introducer <NUM> to move through the access sheath but does it not prevent its effective use. A user can therefore exert some level of force to advance the introducer along the guidewire into and partially through the access sheath <NUM> while still prevent free passage of blood or other fluids between the introducer <NUM> and the access sheath <NUM>. Likewise, the access sheath <NUM> can be removed from the introducer <NUM> as needed. Thus, an interference fit interferes with free passage of blood or other fuilds between the access sheath and introducer. However, a person of ordinary skill would understand that there may be some small amount of fluid loss even with such an interference fit.

As shown in <FIG> and <FIG>, the introducer body <NUM> further defines an introducer length L1 that extends from the proximal tapered tip <NUM> to the distal tapered tip <NUM> along the central axis <NUM>. The access sheath <NUM> defines a sheath length L2 that extends from the front end 21f to the rear end 21r. The length L1 of the introducer <NUM> is at least two times longer than the length L2 of the sheath <NUM>. In one embodiment of the present disclosure, such when the system is used to seal puncture deep in thoracic cavity following a trans-caval procedure, the introducer length L1 is between about <NUM> and about <NUM>. In one example of such an embodiment, the introducer length is between about <NUM> and about <NUM>. In another example, the introducer length is about <NUM>. In another embodiment, such as when the system is used to seal puncture in vessel within patient's limb, the introducer length L1 can be between about <NUM> and about <NUM>. In one example of such an embodiment, the introducer length is between about <NUM> and about <NUM>. In another such example, the introducer length is about <NUM>.

As shown in <FIG>, the introducer body <NUM> includes at least one marker <NUM>. Thus, there may be a single marker <NUM> or a plurality of markers. In an event, the marker <NUM> can be positioned to aid in identifying the location of the introducer <NUM> in the vessel. The marker <NUM> is one of a radio opaque band, a radio opaque ink, or a radio opaque paint. In accordance with one embodiment, a distance D1 from the distal tapered tip <NUM> to the marker <NUM> is less than a distance D2 from the marker <NUM> to the proximal tapered tip <NUM>.

Referring to <FIG>, the proximal component <NUM> and the distal component <NUM> are configured to be coupled together. In accordance with the illustrated embodiment, the proximal component <NUM> defines a first engagement member <NUM> opposite to the proximal tapered tip <NUM>, and the distal component <NUM> defines a second engagement member <NUM> opposite to the distal tapered tip. The first engagement member <NUM> is configured to engage the second engagement member <NUM> so as to couple the proximal and distal components together.

The proximal component <NUM> and the distal component <NUM> are configured to be coupled together via one an interference fit. Accordingly, as illustrated in <FIG>, the first engagement member <NUM> defines a projection <NUM>, and the second engagement member <NUM> defines a cavity <NUM> sized to receive the projection <NUM>. However, it should be appreciated that one of the first engagement member <NUM> and the second engagement member <NUM> defines a cavity, and the other of the first engagement member <NUM> and the second engagement member <NUM> defines a projection that is sized to fit in the cavity. Accordingly, either component <NUM>, <NUM> may have the projection or cavity as needed.

<FIG> illustrates another embodiment an introducer <NUM> that couples the proximal component and the distal component via a snap-fit connection. The introduce <NUM> is substantially similar to the introducer <NUM> described above and shown in <FIG>. For this reason, similar reference numbers are used to identify features that are common to introducer <NUM> and introducer <NUM>. The introducer <NUM> includes a proximal component <NUM> and a distal component <NUM>. In accordance with the embodiment shown in <FIG>, a first engagement member <NUM> includes a ridge <NUM> and the second engagement member <NUM> includes a groove <NUM> that is sized to receive the ridge <NUM>. However, it should be appreciated that one of the first engagement member <NUM> and the second engagement member <NUM> defines a ridge, and the other of the first engagement member <NUM> and the second engagement member <NUM> defines a groove that is sized to receive the ridge.

In another alternative embodiment, the proximal component and the distal component an introducer may be configured to be coupled together via a threaded connection (not shown). For instance, one of the first engagement member and the second engagement member define external threads, and the other of the first engagement member and the second engagement member define internal threads configured to threadably mate with the external threads.

<FIG> illustrates another embodiment an introducer <NUM> that couples the proximal component and the distal component via a coupler <NUM>. The introducer <NUM> is substantially similar to the introducer <NUM> described above and shown in <FIG>. For this reason, similar reference numbers are used to identify features that are common to introducer <NUM> and introducer <NUM>. As shown in <FIG>,the introducer <NUM> includes a coupler <NUM> having a first end <NUM> and a second end <NUM> opposite the first end <NUM>. The first end <NUM> is configured to be coupled to the proximal component <NUM> and the second end <NUM> is configured to be coupled to the distal component <NUM>. The first and second ends <NUM> and <NUM> have first and coupling members <NUM> and <NUM>, respectively. The first coupling member <NUM> can connect to the first engagement member <NUM> of the proximal component <NUM>. The second coupling member <NUM> can connect to the second engagement member <NUM> of the distal component <NUM>. The proximal component <NUM>, the coupler <NUM>, and the distal component <NUM> when coupled together can define the introducer <NUM>. The engagement members <NUM>, <NUM> and the coupling members <NUM>,<NUM> can be ridges, projections, tabs, or other structures or devices that can coupled parts to each other. Accordingly, the coupler <NUM> and ends of the distal component <NUM> and proximal component <NUM> may be configured for any type of connection, such as an interference fit, snap-fit, threaded connection, or the like.

Referring generally to <FIG>, the proximal tapered tip <NUM> of the introducer <NUM> is configured to be inserted into the front end 21f and of the access sheath <NUM> and through the lumen of access sheath <NUM>. The sealing element <NUM> extends out from the front end 21f of the access sheath when the portion of the vascular device is coupled to the hub 21b.

As shown in <FIG> and <FIG>, the access sheath <NUM> is configured to be inserted over the introducer <NUM> and into the vessel. The access sheath <NUM> includes a hub 21b and shaft 21d that extends from the hub 21b in the distal direction <NUM>. The access sheath <NUM> has a front end 21f, a rear end 21r opposite to the front end 21f, and a lumen (not numbered) that extends from the front end 21f to the rear end 21r. The rear end 21r of the access sheath includes the hub 21b that is configured to be coupled to a portion of the deployment assembly <NUM>. When sheath <NUM> is coupled to the deployment assembly <NUM>, the shaft 21d extends along the release component <NUM> and delivery component <NUM> in the distal direction <NUM>.

Referring to <FIG>, a vascular closure device <NUM> includes a sealing device or implantable unit <NUM> at least partially disposed within a deployment assembly <NUM>. The vascular closure device <NUM> can be configured such that after a distal portion of deployment assembly <NUM> is inserted through a puncture site of the vessel, the sealing device <NUM> is deployed to thereby seal or otherwise close the puncture site of the vessel. The deployment assembly <NUM> is configured to control orientation of a toggle <NUM> of the sealing device <NUM> in an easier and more efficient manner during deployment of the sealing device <NUM>. Furthermore, the deployment assembly <NUM> is configured to reduce forces required to deploy the sealing device <NUM> and seal the puncture.

In accordance with the illustrated embodiment, the deployment assembly <NUM> includes a release component <NUM> that restrains the toggle <NUM>, a delivery component <NUM> that contains at least a portion of the toggle <NUM> and a suture <NUM> of the sealing device <NUM>, a guide member <NUM>, and one or more actuators <NUM> coupled to the release component <NUM>. The deployment assembly <NUM> may also include a tamper <NUM>, in the form a tube, that extend along the suture <NUM> is a located proximal with respect to the locking member <NUM> (See <FIG>). The guide member <NUM> extends through the sealing device <NUM> and is configured to receive a guidewire <NUM> as will be discussed below. In another example, the deployment assembly <NUM> can be configured so that the guidewire <NUM> extends along the side of the toggle <NUM>. The release component <NUM> is operatively associated with the suture <NUM> such that actuation of the actuator <NUM> causes the release component <NUM> to <NUM>) release the toggle <NUM>, and <NUM>) apply tension to the suture <NUM>, which urges the toggle <NUM> against the delivery component <NUM> and orients the toggle <NUM> in the sealing position. The guide member <NUM> is configured to be removed from at least the sealing device <NUM> prior the sealing device <NUM> sealing the puncture.

Turning to <FIG>, the sealing device <NUM> includes the toggle <NUM> connected to the suture <NUM>, a plug <NUM> coupled to the suture <NUM> and spaced from the toggle <NUM> in a proximal direction <NUM>, and a locking member <NUM> proximal to the plug <NUM>. The toggle <NUM> includes a distal end 45d and a proximal end 41p opposite to the proximal end 41p, and a plurality of apertures (not numbered) extending therethrough. The suture <NUM> extends through the apertures as illustrated such that an end of the suture <NUM> is formed into a slidable knot <NUM>. The knot <NUM> is slidable along the suture <NUM> between the plug <NUM> and the locking member <NUM>. In an implanted state, the toggle <NUM> is adjacent an inner surface of the vessel and the locking member <NUM> squeezes the toggle <NUM> the plug <NUM> against the vessel to seal the puncture. See for example <FIG>.

The sealing device <NUM> is formed with materials suitable for surgical procedures such as any biocompatible material. For example, the toggle <NUM> can be made of a polylacticcoglycolic acid or other synthetic absorbable polymer that degrades in the presence of water into naturally occurring metabolites. In other embodiments, the toggle can be made of stainless steel, biocorrodible iron, and biocorrodible magnesium. It should be appreciated, however, that the toggle <NUM> can be made of other materials and can have other configurations so long as it can be seated inside the vessel against the vessel wall. The plug <NUM> can comprise a strip of compressible, resorbable, collagen foam and can be made of a fibrous collagen mix of insoluble and soluble collagen that is cross linked for strength. It should be appreciated, however, that the plug member <NUM> can have any configuration as desired and can be made from any material as desired. The suture <NUM> can be any elongate member, such as, for example a filament, thread, or braid.

Referring again <FIG> and <FIG>, the deployment assembly <NUM> is elongate along a longitudinal direction L and includes a rear end 16p and a front end 16d spaced from the rear end 16p along an axis <NUM> that is aligned with the longitudinal direction L. The longitudinal direction L can include and define a distal direction <NUM> that extends from the rear end 16p toward the front end 16d. Further, the longitudinal direction L can include and define a proximal direction <NUM> that is opposite the distal direction <NUM> and that extends from front end 16d toward the rear end 16p. The deployment assembly <NUM> is configured to insert the toggle <NUM> into the vessel along an insertion direction I (see <FIG>). The longitudinal direction L can be aligned with the insertion direction I during a portion of the sealing procedure.

Turning to <FIG>, in accordance with the illustrated embodiment, the deployment assembly <NUM> includes a handle member <NUM>, the release component <NUM> supported by the handle manner <NUM> and extending from handle member <NUM> in the distal direction <NUM>, the delivery component <NUM> also supported by the handle member <NUM> and extending along the distal direction <NUM>, and a tensioner <NUM> supported by the handle member <NUM> and positioned adjacent to the release component <NUM>. A portion of delivery component <NUM> is shown in dashed lines in <FIG>.

The actuator <NUM> is coupled to both the handle member <NUM> and the release component <NUM>. As noted above the actuator <NUM> is configured to <NUM>) cause the release component <NUM> to move in the proximal direction <NUM> from a first or initial position relative to the delivery component <NUM> into a second or releasing position relative to the delivery component <NUM>, and <NUM>) apply a tensile force to the suture <NUM> during or subsequent to movement of the release component <NUM> from the initial position into the released position. The description below refers to the release component <NUM> being moveable relative to the delivery component <NUM>. But the deployment assembly <NUM> can be configured so that the delivery component <NUM> is moveable relative to the release component <NUM>. The deployment assembly <NUM> also includes the guide member <NUM> that extends through the deployment assembly <NUM>, and an outer sheath <NUM> that contains and supports portions of the release component <NUM> and delivery component <NUM>. Furthermore, the actuator <NUM> may be adapted to operate, or cause move the tamper <NUM> along the suture <NUM> to tamp the sealing unit into a tamped, deployed configuration. In alternative embodiment, an separate actuator may be used to control the tamper <NUM>.

Continuing with <FIG>, the handle member <NUM> includes a housing 21a and a cavity 21c defined at least partly by housing 21a and a nose 21b of the access sheath <NUM>. The cavity 21c is sized to contain a portion of the release component <NUM>, delivery component <NUM>, and the tensioner <NUM>.

Turning to <FIG>, <FIG>, the release component <NUM> is elongate along a first or longitudinal direction L defines a distal end 25d and a proximal end 25p spaced from the distal end 25d along the longitudinal direction L. In accordance with the illustrated embodiment, the release component <NUM> includes a release hub <NUM> and a release tube <NUM> that is fixed to the release hub <NUM> extends from the release hub <NUM> in the distal direction <NUM>. The release hub <NUM> includes a pair of tabs 29a, 29b disposed at the proximal end 25p of the release component <NUM>. A pulley <NUM> is coupled to the tabs 29a, 29b and defines a curved track that receives the suture <NUM> as will be explained below. The hub <NUM> defines a slot <NUM> that is elongate along the longitudinal direction L and is aligned with the release tube <NUM>. The slot <NUM> is sized to receiver a coupler <NUM> of the tensioner <NUM>.

The release tube <NUM> includes a release tube body <NUM> that is elongate along the longitudinal direction L. The release tube body <NUM> defines a release tube channel <NUM> that extends along the longitudinal direction L from the hub <NUM> toward the proximal end 25p. In the illustrated embodiment, the release tube channel <NUM> (<FIG>) extends completely through the release tube body <NUM> from the hub <NUM> to the distal end 25d. Furthermore, in the illustrated embodiment the release tube body <NUM> is cylindrical such that the release tube channel <NUM> is radially enclosed. It should be appreciated, however, that the release tube channel <NUM> can extend partially through the release tube body <NUM> as desired and that the release tube body <NUM> can have other configurations as desired. For example, the release tube body <NUM> can be U-shaped such that the release tube channel <NUM> is partially radially open. As shown, the release tube channel <NUM> is sized to slidably receive a portion of the delivery component <NUM> such that the release component <NUM> is movable relative to the delivery component <NUM>.

Referring to <FIG>, <FIG>, and <FIG>, the pulley <NUM> is disposed at the proximal end 25p of the release component <NUM>. As shown, the suture <NUM> extends around the pulley <NUM> along the guide track and into the tensioner <NUM>. As the release component <NUM> is pulled in the proximal direction <NUM>, the pulley <NUM> pulls the suture <NUM> in proximal direction <NUM> thereby applying a tensile force to the toggle <NUM>. In such an embodiment, the tensioner <NUM> is positioned alongside the release component <NUM>. It should be appreciated, however, that in some embodiments, the tensioner <NUM> is positioned proximal to the release tube and is in-line with the release component <NUM> such that the suture <NUM> extends through the release tube and into the tensioner <NUM> along the first direction L.

With continued reference to 6A, 6B, 6D, and 6I, the release component <NUM> can include at least one mating member <NUM> that mates with a corresponding mating member <NUM> of the actuator <NUM> to thereby transfer the motion of the actuator <NUM> to the release component <NUM>. In the illustrated embodiment, the release component mating member <NUM> is a pair of slots 65a and 65b defined by the respective pair of tabs 29a and 29b. Each slot 65a and 65b is elongate along a direction a vertical direction V that is perpendicular to the first direction L. The actuator <NUM> mating member <NUM> can be operatively engaged with elongate slots 65a and 65b of release component <NUM> such that actuation of the actuator <NUM> causes the release component <NUM> to translate along the first direction L. It should be appreciated, however, that the mating member <NUM> can have any configuration as desired. For example, the mating member <NUM> can be a bore having a diameter that is equal to that of the pin such that translation of the actuator <NUM> along the first direction L causes the release component <NUM> to translate along the first direction L.

As shown in <FIG>, <FIG>, the delivery component <NUM> is coupled to the tensioner <NUM> and extends along the release component <NUM> toward the front end 16d of the deployment assembly <NUM>. In accordance with the illustrated embodiment, because the tensioner <NUM> is fixed to the housing 21a, the delivery component <NUM> is fixed to the housing 21a and thus the handle member <NUM>. The delivery component <NUM> includes a delivery tube body <NUM> that is elongate along the first direction L and defines a distal end 27d and a proximal end 27p spaced from the distal end 27d in the first direction L. The delivery tube body <NUM> defines an inner surface <NUM>, which in turns defines a delivery tube channel <NUM> that extends at least partially through the delivery tube body <NUM> along the first direction L. As illustrated embodiment, the delivery tube channel <NUM> extends completely through the delivery tube body <NUM> from the proximal end 27p to the distal end 27d. However, the channel <NUM> can extend along a portion of the delivery tube body <NUM>. Furthermore, in the illustrated embodiment the delivery tube body <NUM> is cylindrical such that the delivery tube channel <NUM> is radially enclosed. It should be appreciated, however, that the delivery tube channel <NUM> can extend partially through the delivery tube body <NUM> as desired and that the delivery tube body <NUM> can have other configurations as desired. For example, the delivery tube body <NUM> can be U-shaped such that the delivery tube channel <NUM> is partially radially open. As illustrated, the proximal end 27p of delivery component is fixed to the tensioner <NUM> and the distal end 27d of delivery component is configured to hold at least a portion of the sealing device <NUM> (<FIG>).

The delivery tube channel <NUM> is sized to retain at least a portion of the sealing device <NUM>. In particular, the plug <NUM> and locking member <NUM> are retained within the delivery tube channel <NUM>, while the toggle <NUM> is configured to be initially trapped between the delivery component <NUM> and the release component <NUM>. For instance, the distal end 25d of the release tube <NUM> defines an offset surface <NUM>, which can be angled with respect to the longitudinal axis <NUM>. The offset surface <NUM> and inner surface <NUM> of the delivery tube <NUM> define a cavity <NUM> that receives the proximal end 41p of the toggle <NUM> when release component <NUM> is in the initial position (as shown in <FIG>). The angle of the offset surface <NUM> can define the orientation of the toggle <NUM> in this initial position, whereby the distal end 45D of the toggle <NUM> is spaced some distance in the distal direction <NUM> beyond the distal ends 25d and 27d of the release component <NUM> and delivery component <NUM>, respectively. The suture <NUM> extends from the toggle <NUM> through the delivery tube channel <NUM>, through the proximal end 27p (<FIG>) around the pulley <NUM> along the guide track and is coupled to the tensioner <NUM>. The guide member <NUM> extends through the channel <NUM> and exits the front end 16d of the vascular closure device <NUM>. When the actuator <NUM> is actuated as will be further detailed below, the release component <NUM> moves in the proximal direction <NUM> thereby releasing the proximal end 41p of the toggle <NUM> from between the release component <NUM> and the delivery component <NUM>. As the release component <NUM> moves in the proximal direction <NUM>, the suture <NUM> will be pulled in the proximal direction <NUM> to thereby place the suture <NUM> in tension and urge the toggle <NUM> against the distal end 27d of the delivery component <NUM>. At this point, the toggle <NUM> is oriented in the sealing position (see <FIG>). In the sealing position, the toggle <NUM> has been repositioned so that the toggle <NUM> is placed against the distal end 27d of the delivery component <NUM> and is oriented more transversely with respect to the axis <NUM> compared to the position when the toggle <NUM> is restrained by the release component <NUM>.

As shown in <FIG>, the tensioner <NUM> disposed on the delivery component <NUM> and is positioned alongside the release component <NUM> so as to receive the suture <NUM> as noted above. In accordance with the illustrated embodiment, the tensioner <NUM> includes a tensioner housing <NUM>, a coupler <NUM> that extends from the housing <NUM> and is attached to the delivery component <NUM>, and a drag member <NUM> disposed within the tensioner housing <NUM>. The suture <NUM> extends into the tensioner housing <NUM> through the drag member <NUM> and such that a frictional force is applied to the suture <NUM> by the drag member <NUM>. The tensioner housing <NUM> is coupled the housing 21a and fixed thereto. The coupler <NUM> as illustrated is a tubular component that receives the proximal end 27p of the delivery tube body <NUM>. As illustrated, the delivery tube body <NUM> is fixed to the coupler <NUM> which indirectly fixes the delivery component <NUM> to the housing 21A.

The suture <NUM> extends from the proximal end 27p of the delivery tube body <NUM>, through the coupler <NUM>, around the pulley <NUM> and into the drag member <NUM> and is spooled within the tensioner housing <NUM> (not shown). Spooling the suture <NUM> in tensions housing <NUM> allows suture <NUM> to dispends from the deployment assembly <NUM> when the deployment assembly <NUM> is pulled is proximal direction <NUM> to thereby deploy the sealing device <NUM> (see <FIG> and <FIG>). The frictional force applied to the suture <NUM> by the drag member <NUM> can be high enough to maintain the suture <NUM> in tension after the actuator <NUM> has been actuated and the toggle <NUM> has been urged against the distal end 27d of the delivery component <NUM>. At the same time the frictional force applied to the suture <NUM> by the drag member <NUM> can be low enough to allow the suture <NUM> to dispense from the tensioner housing <NUM> when the deployment assembly <NUM> is pulled in a proximal direction <NUM> relative to the toggle <NUM>. In the illustrated embodiment, the drag member <NUM> is a silicon member that pinches the suture <NUM>. The tensioner <NUM> and drag member <NUM> can be similar the tensioner described in <CIT>. It should be appreciated, however, that the drag member <NUM> can have other configurations as desired.

Turning to <FIG>, the deployment assembly <NUM> can include one or more actuators that are configured to transition the release component <NUM> into to releasing position and to cause a tension to be applied to suture <NUM> when toggle <NUM> is released from the release component <NUM> as described above. As noted above, the actuator <NUM> can include the mating member <NUM> that operatively engages the mating member <NUM> of the release component <NUM> such that motion of the actuator <NUM> relative to the handle member <NUM> causes the release component to translate in the proximal direction <NUM> and further applies a tension to the filament.

In accordance with the illustrated embodiment, the actuator <NUM> can be configured as a lever that is rotatably coupled to the handle member <NUM>. The actuator <NUM> or lever can include a pair of side members 71a and <NUM> rotatably coupled to each side of the housing 21a, a first leg 37a that extends from one of the side members 71a, a second leg 37b that extends from the other side member 71b, and a transverse member <NUM> that connects the first leg 37a to the second leg 37b. The actuator <NUM> is configured to pivot about a pivot axis AP that is perpendicular to the axis <NUM>. The pivot axis AP may or may not intersect axis <NUM>. The housing 21a defines a curved housing slot <NUM> that is curved with respect to the pivot axis AP. The curved housing slot <NUM> has a first end 69a (<FIG>) and second end (not numbered) spaced apart from the first end along the proximal direction <NUM>. The mating member <NUM> of the actuator <NUM> can be a pin <NUM> that is coupled to and extends between the side members <NUM> and 71b at a location that is offset from the pivot axis AP. The pin <NUM> extends through curved housing slot <NUM> and through the elongate slots 64a and 64a of the hub <NUM> of the release component <NUM> such that the actuator <NUM> is operatively coupled to the release component <NUM>.

In use, as the actuator <NUM> pivots about the pivot axis AP, the pin <NUM> moves from the first end 69a the curved housing slot <NUM> toward the second end of the curved housing slot <NUM>, and also moves along the slots 64a and 64b along the vertical direction V. Because the release component <NUM> is moveable relative to housing 21a, as pin <NUM> moves along the curved housing slot <NUM>, the pin <NUM> advances the hub <NUM> of the release component <NUM> in the proximal direction <NUM>. The result in accordance with the illustrated embodiment is that rotation of the actuator <NUM> causes the release component <NUM> to translate in the longitudinal direction L. It should be appreciated, however, that the actuator <NUM> can have other configurations as desired and is not limited to the disclosed lever.

In operation, the deployment assembly <NUM> is initially configured to insert the toggle <NUM> into the vessel. When the actuator <NUM> is actuated, the release component <NUM> moves in the proximal direction <NUM> relative to the delivery component <NUM> into the releasing position (not illustrated) thereby releasing the proximal end 41p of the toggle <NUM> from between the release component <NUM> and the delivery component <NUM>. As the release component <NUM> moves in the proximal direction <NUM>, the suture <NUM> will be pulled in the proximal direction <NUM> to thereby place the suture <NUM> in tension and urge the toggle <NUM> against the distal end 27d of the delivery component <NUM>. At this point, the toggle <NUM> is oriented in the sealing position (see <FIG>). Accordingly, the release component <NUM> is configured to restrain the toggle <NUM> of the sealing device <NUM> during insertion of the vascular closure device <NUM> into the vessel and subsequently release the toggle <NUM> so that the toggle <NUM> can be oriented for the sealing procedure.

The release component <NUM> is also in communication the suture <NUM> via the pulley <NUM> such that when the actuator <NUM> is actuated the release component <NUM> pulls the suture <NUM> in the proximal direction to thereby place the suture <NUM> in tension. Application of tension along the suture <NUM> urges the toggle <NUM> against the distal end 27d of the delivery component <NUM> and orients the toggle <NUM> into the sealing position. In the illustrated embodiment, the actuator <NUM> and release component <NUM> are configured such that continuous movement of the actuator <NUM> relative to the housing 21a will move the release component <NUM> in the proximal direction <NUM>, thereby releasing the toggle <NUM> from the release component <NUM> and subsequently apply tension to the suture <NUM>. It should be appreciated, however, that in some embodiments the suture <NUM> can be tensioned as the toggle <NUM> is being released. It should further be appreciated that in some embodiments, the deployment assembly <NUM> can include a first actuator to release the toggle <NUM> and a second actuator that tensions the suture <NUM>.

The release component <NUM> and delivery components <NUM> are described above has having tubular shaped bodies. It should be appreciated that the release and delivery components can have other configurations. For instance, the release component can be elongate rod, or an elongate rod with a tubular ring coupled to its distal end. The delivery component can be configured such that only a portion thereof has a tubular shape.

Embodiments of the present technology will now be described with respect to exemplary large bore procedures that utilize the vascular closure system <NUM> illustrated in <FIG>. 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 is inserted into the vessel <NUM> through a procedure sheath PS (referred to as the first access sheath). A guidewire is then advanced through the hollow needle into the femoral artery a sufficient distance to allow removal of the needle without the guidewire pulling out of the vessel. Removing the needle leaves the guidewire in place, with a portion of the guidewire extending into the artery and proximal end PE of the sheath PS extending out patient. The guidewire, extending from outside the patient into the femoral artery, provides for an entry guide for other medical devices including the access sheath <NUM>, introducer <NUM>, and vascular closure device <NUM>. Therefore, once the guidewire is positioned in the vessel of the patient, catheters, or introducers, of gradually increasing diameters are advanced over the guidewire and through the puncture into the artery to further open the puncture site. Then, a procedure access sheath set (i.e. an introducer <NUM> inside a procedure sheath PS) is moved along the guidewire such that a distal end DE of the sheath PS moves into the vessel through the puncture site. And once 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 during percutaneous access of the artery may be closed. The vascular closure system may be used to seal the puncture site.

In some instances, however, access through the femoral artery as described above is not indicated due to condition of the vessel between the femoral artery and the aorta. In such cases, a trans-caval procedure can be used to access the aorta. As shown in <FIG>, the trans-caval procedure includes guiding a guidewire <NUM> through into through a first puncture <NUM> in a femoral vein <NUM> and further into and a portion of the inferior vena cava <NUM>. The method include creating a second puncture <NUM> in the portion of the inferior vena cava <NUM> and creating a third puncture <NUM> in a femoral artery <NUM> and a portion of the aorta <NUM>. The punctures can formed with a tip of the guidewire <NUM>, such as by burning. Next, the distal end DE of the procedure access sheath PS is guided along the guidewire <NUM> through the second and third punctures. When the sheath PS is in place, a medical device, such as a catheter, is inserted through the first access sheath PS. When the procedure is completed, the catheter is removed from the procedure access sheath PS and the guidewire <NUM>.

Continuing with <FIG>, a method includes positioning a tapered distal end <NUM> of an introducer over a proximal end <NUM> of a guidewire <NUM> that extends through a puncture <NUM> in a vessel <NUM>, e.g. a vena cava, such that the guidewire <NUM> enters a bore <NUM> of the introducer. In the example illustrated, the procedure sheath PS and guidewire <NUM> extends from the outside the patient into the femoral venal cava.

Next, as shown in <FIG>, the method includes advancing the introducer 100along the guidewire <NUM> in a distal direction <NUM> so that the tapered distal end enters the proximal end PE of the first access sheath PS. The introducer <NUM> further advanced out of a distal end DE of the access sheath PS that is spaced from the proximal end PE of the access sheath PS in the distal direction <NUM>. The introducer <NUM> is advanced in the distal direction until a marker <NUM> disposed toward the tapered distal end is positioned within a predetermined distance of the puncture of the vessel.

As shown in <FIG> and <FIG>, the method includes removing the access sheath PS from the punctures <NUM>, <NUM> and <NUM> while maintaining a portion of the tapered distal end <NUM> of the introducer <NUM> in the aorta <NUM> (or some other vessel as the case may be).

As shown in <FIG>, after the removing step, the procedure includes the step of inserting the access sheath <NUM> of system <NUM> (also referred to as the second access sheath) over the tapered proximal end of the introducer until a distal or front end <NUM> of the access sheath <NUM> extends through the puncture of the vessel.

As shown in <FIG>, the method includes the step of removing the introducer <NUM> from the access sheath <NUM> and the guidewire <NUM>. The exchange of sheaths PS and <NUM> limits blood loss and ensure smooth transition between the interventional procedure and sealing the puncture site.

As shown in <FIG>, the method includes advancing a vascular closure device, for instance the deployment assembly <NUM>, into the access sheath <NUM> to seal the puncture. In one example, the method can also include the steps of sealing the puncture <NUM>, sealing puncture <NUM> and sealing puncture <NUM>. In most cases, the sealing device <NUM> is deployed as illustrated in <FIG>. As deployed, the toggle <NUM> is adjacent the vessel wall <NUM>, the plug <NUM> is collapses against the outer surface of the wall <NUM> and opposite the toggle <NUM>. The knot <NUM> and lock member <NUM> secure the plug <NUM> in place, compressing the plug <NUM> and toggle <NUM> together.

It should be appreciated that the introducer <NUM> can be assembled during manufacture or at the surgical site prior to its use as described above. The method can include coupling a distal component <NUM> of the introducer <NUM> to a proximal component <NUM> of the introducer, wherein the distal component <NUM> defines the tapered distal end <NUM> and the proximal component <NUM> defines the tapered proximal end <NUM>.

Claim 1:
A system configured to seal a puncture in a vessel, comprising:
an introducer (<NUM>) configured to be inserted through the puncture along a guidewire (<NUM>) that extends through the puncture into the vessel, the introducer including an introducer body (<NUM>) that is elongate along a central axis (<NUM>), a proximal tapered tip (<NUM>), a distal tapered tip (<NUM>) that is opposite to the proximal tapered tip (<NUM>) along the central axis (<NUM>), and a bore (<NUM>) that extends from the proximal tapered tip (<NUM>) to the distal tapered tip (<NUM>) along the central axis (<NUM>), the bore (<NUM>) sized to receive the guidewire (<NUM>) therethrough, wherein the distal tapered tip (<NUM>) is configured to be inserted into the vessel along the guidewire (<NUM>);
an access sheath (<NUM>) configured to be inserted over the introducer (<NUM>) and into the vessel, the access sheath (<NUM>) including a front end (21f) , a rear end (21r) opposite to the front end (21f), and a lumen that extends from the front end (21f) to the rear end (21r), wherein the proximal tapered tip (<NUM>) of the introducer (<NUM>) is configured to be inserted through the front end (21f) and into the lumen of access sheath (<NUM>) such that an interference fit allowing relative movement between the access sheath (<NUM>) and the introducer (<NUM>) is attained; and
a vascular closure device (<NUM>) including a sealing element (<NUM>) configured to seal the puncture of the vessel, wherein when the introducer (<NUM>) has been removed from the lumen of the access sheath (<NUM>), the rear end (21r) of the access sheath (<NUM>) is configured to receive the vascular closure device (<NUM>) such that the sealing element extends out of the front end (21f) of the access sheath (<NUM>).