Patent Description:
The present disclosure relates to a vascular closure device with a locking assembly for a tamper.

Percutaneous access of the vascular system for vascular device delivery is a common medical procedure. Typically this involves using a hollow needle to puncture a vessel, then introducing an introducer sheath to open the puncture site for the introduction of catheters and wire guides for navigation through the vascular system to facilitate delivery. For example, in many cases, vascular access requires introduction of catheters and wire guides through the femoral artery. Once the procedure is completed, the devices are removed from the patient and pressure is applied to the puncture site to stop the bleeding. Thereafter, the puncture may be sealed using a closure device. Closure devices generally consist of three basic sealing components: a toggle (or anchor) member, a sealing member, such as a plug, and a suture. To lock the components together within the puncture, a locking member may be used.

<CIT> to Forsberg involves an automatic suture locking device useable with vascular closure device. The suture locking device in Forsberg includes a housing and a locking mechanism with locked and unlocked positions. International Patent Publication No. <CIT> to Walters is directed to a closure device for sealing a percutaneous puncture in a wall of a body passageway. The device includes an anchor configured to engage an interior surface of the body passageway, a plug, a contiguous elongate filament, coupled to the anchor and the plug, including first and second sections extending from the anchor with the first section extending through a collar connected to the second section such that a loop is formed. The loop extends through an orifice in the plug, a lock frictionally engaged to a portion of the first section extending beyond said loop, wherein the lock is movable along the filament. As the lock is moved towards the anchor, the loop shrinks causing the plug to move toward the anchor, wherein the lock is configured to prevent the loop from expanding after said shrinkage of the loop. International Patent Publication No. <CIT> to Bagaoisan describes an apparatus and methods for sealing a vascular puncture. The apparatus includes a cartridge, a pusher member, a sealant and a tamping device on a proximal end of the cartridge. <CIT> to Ditter is directed to an internal tissue puncture closure method and apparatus. The method and apparatus provide a locking device for compressing and holding an external component such as a collagen sponge at a puncture situs. The locking device facilitates compression of the external component in a first direction, but prevents or locks against retraction.

The present invention is defined in and by the appended claims. A vascular closure device in accordance with the invention includes a deployment assembly that is elongate along a longitudinal direction and that has a distal end and a proximal end spaced from the distal end in a proximal direction that is aligned with the longitudinal direction. The vascular closure device includes a sealing unit carried by the deployment assembly. The sealing unit includes a suture coupled to the deployment assembly. The vascular closure device includes a tamper carried by the deployment assembly and that is disposed along the suture with respect to the sealing unit in the proximal direction. The tamper includes a lumen that receives the suture such that the tamper is slidable along the suture. The vascular closure device includes a locking assembly coupled to the tamper so as to selectively inhibit advancement of the tamper along the suture in the distal direction toward the sealing unit. The locking assembly is adapted to transition from A) a locked configuration where the tamper is inhibited from sliding along the suture, into B) an unlocked configuration where the tamper is slidable along the suture in the distal direction and into contact with the sealing unit. The locking assembly includes a lever coupled to a tensioning element, the lever including an engagement end. When the locking assembly is in the locked configuration the engagement end is disposed in a notch in the tamper such that the tamper is inhibited from sliding along the suture.

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

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>, embodiments of the present disclosure include a puncture closure system <NUM> used to seal puncture in an arterial wall. The puncture closure system <NUM> includes an introducer (not shown), such as a dilator, and a vascular closure device <NUM> that is configured to seal the puncture in an arterial wall. The vascular closure device <NUM> includes a sealing device <NUM>, a deployment assembly <NUM> that releasably carries the sealing device <NUM>, and an access sheath <NUM>. The access sheath <NUM> can be inserted into the puncture along a guidewire <NUM> (<FIG>) and over the introducer to form an insertion assembly. After the introducer is removed from the access sheath <NUM>, the deployment assembly <NUM> can be inserted into, and coupled with, the access sheath <NUM> to position the sealing device <NUM> (<FIG>) in the artery.

Turning to <FIG>, the vascular closure device <NUM> includes a sealing unit <NUM> and a tamper <NUM> at least partially disposed within a deployment assembly <NUM>. The sealing unit <NUM>, which may be referred to as an implantable unit, includes a toggle <NUM>, a suture <NUM> coupled to the toggle <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> disposed on the suture <NUM> proximal to the plug <NUM>. The vascular closure device <NUM> is configured such that after a distal portion of deployment assembly <NUM> is inserted through the puncture site of the vessel, the sealing unit <NUM> can be deployed to seal or otherwise close the puncture site. The deployment assembly <NUM> controls orientation of the toggle <NUM> as the sealing unit <NUM> is advanced through the access sheath <NUM> in an easier and more efficient manner. Furthermore, the deployment assembly <NUM> is also configured to reduce forces required to deploy the sealing unit <NUM> and seal the puncture.

Referring to <FIG>, the toggle <NUM> includes a distal end 41d, 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 to an inner surface of the vessel and the locking member <NUM> squeezes the toggle <NUM> and the plug <NUM> against the vessel to seal the puncture.

The sealing unit <NUM> is formed with materials suitable for surgical procedures. The toggle <NUM> can be made of any biocompatible material. For example, the toggle <NUM> can be made of a polylactic-coglycolic acid or other synthetic absorbable polymer that degrades in the presence of water into naturally occurring metabolites. In other embodiments, the toggle <NUM> 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.

The vascular closure devices includes a tamper <NUM> disposed along the suture <NUM> in a proximal direction with respect to the locking member <NUM>. The tamper <NUM> includes a first lumen that receives the suture <NUM> therethrough and a second lumen that receives the guide member <NUM>. The tamper <NUM> is selectively slideable along the suture <NUM> to tamp the locking member <NUM> into a compressed plug so as to seal the puncture. In accordance with the present disclosure, the vascular closure device <NUM> includes a locking assembly <NUM> that is used to lock the tamper <NUM> in place until a threshold level of tension is applied to the suture <NUM>. After the requisite tension is applied, the locking assembly is unlocked and the tamper <NUM> can be advanced along the suture <NUM> to tamp the locking member <NUM> into position on the plug <NUM>. The locking assembly will be further described below.

Referring to <FIG>, the deployment assembly <NUM> includes a handle member <NUM>, a release component <NUM>, a delivery component <NUM> that contains at least a portion of the toggle <NUM>, a tension element <NUM>, a guide member <NUM>, and one or more actuators <NUM> coupled to the release component <NUM>. The toggle <NUM> is trapped between the release component <NUM> and the delivery component <NUM> as shown in <FIG>. The guide member <NUM> extends through the sealing unit <NUM>, such as the plug <NUM> and toggle <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 to the sealing device <NUM> sealing the puncture.

Referring again to <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. The longitudinal direction L can be aligned with the insertion direction I during a portion of the sealing procedure.

Referring to <FIG>, in accordance with the illustrated embodiment, the deployment assembly <NUM> includes a handle member <NUM>. The handle member <NUM> includes a housing 21a and a cavity 21c defined at least partly by a housing 21a and a hub 21b of the access sheath <NUM>. The cavity 21c is sized to contain a portion of the release component <NUM>, the delivery component <NUM>, and the tension element <NUM>. As shown, the handle member <NUM> supports the release component <NUM> such that the release component <NUM> extends from the handle member <NUM> in the distal direction <NUM>. The delivery component <NUM> also supported by the handle member <NUM> and extends along the distal direction <NUM> within a lumen of the release component <NUM>. The tension element <NUM> is contained in the housing 21a coupled to a proximal end of 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 release 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>.

Turning to <FIG>, the release component <NUM> is elongate along a first or longitudinal direction L. The release component 22defines 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 hub <NUM> and a release tube <NUM> that is fixed to the hub <NUM> and that extends from the hub <NUM> in the distal direction <NUM>. The hub <NUM> is disposed at the proximal end 25p of the release component <NUM>. As illustrated, the release hub <NUM> includes a pair of tabs 29a, 29b, and a pulley <NUM> coupled to and disposed between the tabs 29a, 29b. The pulley <NUM> 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 receive a coupler <NUM> of the tension element <NUM>.

Referring to <FIG>, the release tube <NUM> includes a release tube body that is elongate along the longitudinal direction L. The release tube body defines a release tube channel <NUM> (<FIG>) that extends along the longitudinal direction L from the hub <NUM> toward the distal end 25d. In the illustrated embodiment, the release tube channel <NUM> extends completely through the release tube body from the hub <NUM> to the distal end 25d. The release tube body 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 as desired and that the release tube body can have other configurations as desired. For example, the release tube body 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>. As shown in <FIG>, the suture <NUM> extends around the pulley <NUM> along the guide track and into the tension element <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 tension element <NUM> is positioned alongside the release component <NUM>. It should be appreciated, however, that in some embodiments, the tension element <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 <NUM> and into the tension element <NUM> along the first direction L.

With continued reference to 6A, 6B, and 6D, the release component <NUM> can be operatively coupled to the actuator <NUM>. The release component <NUM> includes at least one mating member 64a, 64b that mates with a corresponding mating member <NUM> of the actuator <NUM>. The mating members 64a, 64b and <NUM> are engaged with other so to 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 64a and 64b defined by the respective pair of tabs 29a and 29b of the hub <NUM>. Each slot 64a and 64b is elongate along a vertical direction V that is perpendicular to the longitudinal direction L. The mating member <NUM>, which can be a pin, is disposed inside the slots 64a and 64b such that actuation of the actuator <NUM> causes the release component <NUM> to translate along the longitudinal direction L. It should be appreciated, however, that the mating member 64a, 64b can have any configuration as desired. For example, the mating member 64a, 64b can be a bore having a diameter that is equal to that of the pin such that translation of the actuator <NUM> causes the release component <NUM> to translate along the first direction L.

As shown in <FIG>, the delivery component <NUM> is coupled to the tension element <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 tension element <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 direction L and defines a distal end 27d and a proximal end 27p spaced from the distal end 27d in the 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>. 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 the delivery component is fixed to the tension element <NUM>. The distal end 27d of the delivery component is configured to hold at least a portion of the sealing device <NUM> (<FIG>).

Referring to <FIG>, the deployment assembly <NUM> releasably carries 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>. As shown, 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 body <NUM> define a cavity <NUM> that receives the proximal end 41p of the toggle <NUM> when the release component <NUM> is in the initial position. The angle of the offset surface <NUM> can define the orientation of the toggle <NUM> in this initial position, whereby the distal end 41d 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 around the pulley <NUM> along the guide track and is coupled to the tension element <NUM>(<FIG>). 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 tension element <NUM> is disposed on the delivery component <NUM> and receives the suture <NUM> as noted above. In accordance with the illustrated embodiment, the tension element <NUM> includes a tension element housing <NUM>, a cartridge <NUM> disposed with the housing <NUM>, and a spring <NUM> between the housing <NUM> and the cartridge <NUM>. The tension element <NUM> also includes 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 tension element housing <NUM>. The suture <NUM> extends into the tension element housing <NUM> through the drag member <NUM> and is attached to the cartridge <NUM> such that a frictional force is applied to the suture <NUM> by the drag member <NUM>. The tension element housing <NUM> is fixed to the housing 21a. The cartridge <NUM> can move with respect to the housing <NUM>. 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> is spooled within the tension element housing <NUM> (not shown). Spooling the suture <NUM> in tension element housing <NUM> allows suture <NUM> to dispense from the deployment assembly <NUM> when the deployment assembly <NUM> is pulled in the proximal direction <NUM> to thereby deploy the sealing device <NUM> from the deployment assembly <NUM>. 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 tension element housing <NUM> when the deployment assembly <NUM> is pulled in the 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 tension element housing <NUM> and drag member <NUM> can be similar to the tension element 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 the toggle <NUM> is released. In accordance with the illustrated embodiment, the actuator <NUM> can be configured as a lever that is rotatably coupled to the handle member <NUM>. Rotation of the lever can cause the release component to translate as to release the toggle <NUM>.

As illustrated in <FIG>, the actuator <NUM> or lever can include a pair of side members 71a and 71b 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 pair of curved housing slots <NUM> that are curved with respect to the pivot axis AP. Only one curved slot <NUM> is shown in the Figures and is described below for illustrative purposes. The curved slots <NUM> are substantially similar to each other. 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 the curved housing slot <NUM> and through the elongate slots 64a and 64b 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 of the curved housing slots <NUM> toward the second end of the curved housing slots <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 the pin <NUM> moves along the curved housing slots <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.

Furthermore, 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.

Referring to <FIG>, the deployment assembly <NUM> described above is inserted into and coupled to the access sheath <NUM>. The access sheath <NUM> is elongate along a longitudinal direction L. The access sheath <NUM> defines a distal end DA, a proximal end PA, and an access channel <NUM> that extends from the proximal end PA to the distal end DA along the longitudinal direction L. The access sheath <NUM> also includes a hub 21b and a shaft 21d that extends from the hub 21b. The proximal end, which can be referred to as the rearward end, of the access sheath includes the hub 21b that is configured to be coupled to a portion of the deployment assembly <NUM>. When the sheath <NUM> is coupled to the deployment assembly, the shaft 21d extends along the release component <NUM> and delivery component <NUM> in a distal direction <NUM>.

The vascular closure device <NUM> as described herein also includes a locking assembly coupled to the tamper <NUM> so as to selectively inhibit advancement of the tamper <NUM> along the suture <NUM>. The locking assembly is adapted to transition from A) a locked configuration where the tamper <NUM> is inhibited from sliding along the suture, into B) an unlocked configuration where the tamper <NUM> is slidable along the suture <NUM> in the distal direction and into contact with the sealing device <NUM>. <FIG> illustrate various embodiments of a locking assembly used to control the tamper <NUM>.

Referring to <FIG>, the vascular closure device <NUM> includes a locking assembly <NUM> used to control release of the tamper <NUM> during use. The locking assembly <NUM> is operatively coupled to the tension element <NUM> so that, in response to the level of tension applied to the suture <NUM>, the locking assembly transitions between the locked configuration and the unlocked configuration. As illustrated, the suture <NUM> is attached to a tension cartridge <NUM> and passes around a pulley <NUM> into a distal end of the tamper <NUM> toward the sealing device <NUM>. As described above, the tension element <NUM> includes the housing <NUM>, a tension cartridge <NUM>, a compression spring <NUM> that fits between the tension cartridge <NUM> and the housing <NUM>. The locking assembly <NUM> includes a biasing plate <NUM> that is coupled to the cartridge <NUM> and the hub <NUM>. A rearward surface on the tension cartridge <NUM> bears against the upper leg <NUM> of the plate <NUM>. A fixed leg <NUM> of the spring plate <NUM> is rigidly attached to the hub <NUM>. In a locked configuration, as shown in <FIG>, the legs <NUM> and <NUM> of the spring plate <NUM> are at an acute angle with respect to each other. The tamper <NUM> extends along the suture <NUM> and passes through an opening <NUM> in the plate <NUM>. The opening in the plate <NUM> has about the same cross-sectional dimension as the tamper <NUM>. The angle of the upper leg <NUM> of the spring plate <NUM> causes the surfaces defining the opening <NUM> to abut the tamper <NUM>, inhibiting movement of the tamper <NUM>.

As shown in <FIG>, when tension is applied to the suture <NUM>, the tension cartridge <NUM> is moved rearward compressing spring <NUM>. The upper leg <NUM> of the spring plate <NUM> is pushed rearward by the rearward facing surface of the cartridge <NUM> until the angle between the upper leg <NUM> of the spring plate <NUM> and the fixed lower leg <NUM> of the plate <NUM> are at a proper angle, releasing the grip of the plate <NUM> on the tamper <NUM>. The tamper <NUM> can then be moved forward through the opening <NUM>.

Another embodiment of a vascular closure device <NUM> and locking assembly is shown in <FIG>. In accordance with an alternative embodiment, a vascular closure device <NUM> includes a locking assembly <NUM>. The vascular closure device <NUM> is substantially similar to the vascular closure device <NUM> and the same reference numbers are used to refer to parts common to vascular closure device <NUM> and vascular closure device <NUM>. The locking assembly <NUM> includes a slide pin <NUM> having an opening <NUM>, and a biasing member <NUM>. The biasing member <NUM> can be a compression spring <NUM>. As illustrated, the suture <NUM> is attached to a tension cartridge <NUM> as described above. The suture <NUM> also passes through the opening <NUM> in a slide pin <NUM>. A compression spring <NUM> applies a downward force on the slide pin <NUM> which, in turn, deflects the suture <NUM> in a downward direction. The slide pin <NUM> is deflected into a notch <NUM> of the tamper <NUM>, which prevents the tamper <NUM> from moving along the longitudinal direction L. When tension is applied to the suture <NUM>, the tension cartridge <NUM> is moved rearward compressing spring <NUM>. Tension in the suture <NUM> applies an upward pressure on the slide pin <NUM>, compressing the spring <NUM> and releasing the slide pin <NUM> from the notch <NUM>. The tamper <NUM> can then be moved forward out of the device to tamp the locking member.

A vascular closure device and locking assembly according to the invention is shown in <FIG>. In accordance with the invention, a vascular closure device <NUM> includes a locking assembly <NUM>. The vascular closure device <NUM> is substantially similar to the vascular closure device <NUM> and the same reference numbers are used to refer to parts common to vascular closure device <NUM> and vascular closure device <NUM>. As illustrated, a locking assembly <NUM> includes a lever <NUM> that includes a fixed or pivoting end <NUM> and a free end <NUM>. The pivoting end <NUM> is pivotably fixed to the hub <NUM> of the release component <NUM>. The lever <NUM> can therefore pivot about end <NUM>. The free end <NUM> of the lever has a projection <NUM> that extends relative to the lever <NUM> at about a right angle. The suture <NUM> is attached to the tension cartridge <NUM>. In accordance with the embodiment shown, the cartridge <NUM> includes a projecting tab <NUM> that defines an opening <NUM>. The lever <NUM> passes through the opening <NUM>. A tamper <NUM> extends along the suture <NUM>. In an initial configuration, the free end <NUM> of the lever <NUM>, e.g. the projection <NUM>, engages a notch <NUM> in the tamper <NUM>, which prevents the tamper <NUM> from moving along the longitudinal direction L. When tension is applied to the suture <NUM>, the tension cartridge <NUM> is moved rearward compressing spring <NUM>. Because the lever <NUM> passes through the opening <NUM> of the tab <NUM>, as the cartridge <NUM> moves rearward, the opening <NUM> (i.e. the tab surface at the lower end of opening <NUM>) rides along the lever <NUM> and lifts the free end <NUM> upwardly (as viewed in the figures). Movement of the free end <NUM> upwardly removes the projection <NUM> from the notch <NUM> in the tamper <NUM>. The tamper <NUM> can then be moved forward.

Another embodiment of a vascular closure device and locking assembly is shown in <FIG>. In accordance with an alternative embodiment, a vascular closure device <NUM> includes a locking assembly <NUM>. The vascular closure device <NUM> is substantially similar to the vascular closure device <NUM> and the same reference numbers are used to refer to parts common to vascular closure device <NUM> and vascular closure device <NUM>. As illustrated, a locking assembly <NUM> includes an engagement tab <NUM>, biasing member <NUM>, and a slide pin <NUM>. The engagement tab <NUM> is disposed on the rearward surface of the tension cartridge <NUM>. The tab <NUM> can engage in the notch <NUM> in the slide pin <NUM>, which fixes the position of the slide pin <NUM>. The biasing member <NUM>, which can be a tension spring, applies an upward force on the slide pin <NUM>, urging the slide pin <NUM> toward the cartridge <NUM>. The tamper <NUM> includes a notch <NUM> and the slide pin <NUM> engages the notch <NUM>, which prevents the tamper <NUM> from moving along the longitudinal direction L. When tension is applied to the suture <NUM>, the tension cartridge <NUM> is moved rearward releasing the engagement tab515 from the notch <NUM> in the slide pin <NUM>. The tension spring <NUM> pulls the slide pin <NUM> upward releasing it from the notch <NUM> in the tamper <NUM>. The tamper <NUM> can then be moved forward as needed.

Another embodiment of a vascular closure device and locking assembly is shown in <FIG>. In accordance with an alternative embodiment, a vascular closure device <NUM> includes a locking assembly <NUM>. The vascular closure device <NUM> is substantially similar to the vascular closure device <NUM> and the same reference numbers are used to refer to parts common to vascular closure device <NUM> and vascular closure device <NUM>. As shown in <FIG>, the locking assembly <NUM> includes a torsion member <NUM>. The torsion member <NUM> has a movable end <NUM>, bent at a right angle, and a fixed end <NUM>, attached to the hub <NUM>. A protrusion <NUM> on the rearward surface of the tension cartridge <NUM> engages the movable end <NUM> of the torsion member <NUM>, holding it in a downward position into engagement with the tamper <NUM>. As illustrated, the moveable end <NUM> is captured by a notch <NUM> of the tamper <NUM>, which prevents the tamper <NUM> from moving along the longitudinal direction L. When tension is applied to the suture <NUM>, the tension cartridge <NUM> is moved rearward disengaging the protrusion <NUM> from the movable end <NUM> of the torsion member <NUM>. The torsion member <NUM> rotates in a counter clockwise direction pulling the moveable end <NUM> out of the notch <NUM> in the tamper <NUM>. The tamper <NUM> can then be moved forward, as needed.

Embodiments of the present technology will now be described with respect to exemplary large bore procedures that utilize the vascular closure system <NUM>. 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 artery. A guide wire <NUM> is then advanced through the hollow needle and into the femoral artery a sufficient distance to allow removal of the needle without the guide wire <NUM> pulling out of the vessel. Removing the needle leaves the guide wire <NUM> in place, with a portion of the guide wire <NUM> extending into the artery. The guide wire <NUM>, extending from outside the patient into the femoral artery, provides for an entry guide for other medical devices including the vascular closure device <NUM>. Therefore, once the guide wire <NUM> 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, an introducer/procedure access sheath set (i.e. an introducer inside an access tube or sheath) is moved along the guide wire <NUM> such that a distal end of the sheath 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 by the bore needle during percutaneous access of the artery may be closed. The vascular closure system <NUM> as describe above and illustrated may be used to seal the puncture site. <FIG> show schematic views of the vascular closure system <NUM> during the process of closing a puncture site <NUM> in a vessel (e.g. artery) wall <NUM>.

Now in reference to <FIG>, to deliver the vascular closure device <NUM> to the puncture site <NUM> so that the sealing element <NUM> can seal the puncture site <NUM>, the introducer/procedure sheath set is replaced with a closure access sheath <NUM>. For example, as shown in <FIG>, the procedure sheath is exchanged for the closure access sheath <NUM> by removing the procedure sheath from the patient, leaving the guide wire <NUM> in place, and subsequently moving the closure access sheath <NUM> along the guide wire <NUM> or otherwise positioning the access sheath <NUM>, such that a portion of the access sheath <NUM> is disposed within the vessel through the puncture site <NUM>. The access sheath <NUM>, e.g. the sheath hub 21b, is configured to couple to the deployment assembly <NUM> when the deployment assembly <NUM> is inserted into the access channel <NUM> along the insertion direction I.

As shown in <FIG>, the vascular closure device <NUM> can be positioned by translating the vascular closure device <NUM> into the access channel <NUM> along the insertion direction I such that the toggle <NUM> protrudes from the distal end DA of the access sheath <NUM> and into the vessel. Once fully inserted, the deployment assembly <NUM> can couple to the sheath hub 21b. As shown in <FIG>, a proximal end the toggle <NUM> is trapped within the release component <NUM> between the release component <NUM> and the delivery component <NUM> while the vascular closure device <NUM> is being moved into the vessel through the puncture site <NUM> of the vessel. While the proximal end of the toggle <NUM> is trapped, the toggle <NUM> is oriented in a pre-sealing position whereby at least the proximal end of the toggle <NUM> is prevented from dragging against the vessel wall during positioning of the toggle <NUM> within the vessel.

Once the vascular closure device <NUM> is properly positioned within the access sheath <NUM>, the toggle <NUM>, and in particular, the entire access sheath <NUM> and vascular closure device <NUM> combination can be moved proximally such that the toggle <NUM> is adjacent the puncture site <NUM>. While the toggle <NUM> is being positioned adjacent the puncture site <NUM> the toggle <NUM> is in the pre-sealing position as shown in <FIG>. And once the toggle <NUM> is in position, the actuator <NUM> is actuated to thereby release the toggle <NUM> from the release tube and subsequently apply a tension to the suture <NUM> so as to pull the toggle <NUM> against the distal end of the delivery component <NUM> as shown in <FIG>. At this point the toggle <NUM> will be oriented in the sealing position as shown in <FIG> and described previously.

With the toggle <NUM> in the sealing position as shown in <FIG>, the deployment assembly <NUM> along with the access sheath <NUM> can together be pulled proximally such that the toggle <NUM> abuts the vessel wall <NUM> as shown in <FIG>. As shown in <FIG>, further pulling of the deployment assembly <NUM> and sheath <NUM> will cause the sealing device <NUM>, including the toggle <NUM>, plug <NUM>, a locking member <NUM>, and suture <NUM> to be withdrawn from the delivery component <NUM>. By pulling on the suture <NUM> in a direction away from the vessel (i.e. in a direction opposite the insertion direction I) the suture <NUM> is tensioned and the toggle <NUM> is moved fully into position against an inner surface of the vessel wall at the puncture site <NUM>. The tension in the suture <NUM> also pulls and/or folds the plug <NUM> proximate the puncture site <NUM>. Thus action causes the plug <NUM> to substantially fill the puncture site <NUM> as shown in <FIG>. After the plug <NUM> is in contact with blood or other fluids within the puncture site <NUM>, the plug <NUM> will expand and fill the remainder of the puncture site <NUM>. When tension reaches a threshold level, the locking assembly will release the tamper <NUM> so that it can be advanced out of the deployment assembly <NUM>.

As shown in <FIG>, after the user has pulled the suture <NUM> to cause tension in the suture <NUM> and to cause the plug <NUM> to enter the puncture site <NUM>, the user advances the tamper <NUM> along the guide wire <NUM> and the suture <NUM>. As shown in <FIG>, the tamper <NUM> contacts the locking member <NUM> and advances the locking member <NUM> along the suture <NUM> until the locking member <NUM> contacts the plug <NUM> and presses the plug <NUM> against an outer surface of the vessel. As the plug <NUM> is compressed by the tamper <NUM> the plug <NUM> folds over the top of and inside the puncture site <NUM>. It should be appreciated, however, that in some embodiments, the delivery component <NUM> is pulled such that the plug <NUM> is removed from the delivery component <NUM> within the release component <NUM> and the tamper <NUM> is employed within the release component <NUM>. In such an embodiment, the release component <NUM> helps control the plug <NUM> as it is being tamped against the puncture site.

As shown in <FIG>, the locking member <NUM>, together with the plug <NUM> and the toggle <NUM> seals the puncture site <NUM>. As shown in <FIG>, tension is maintained on the suture <NUM> throughout the deployment of the plug <NUM> from the delivery component <NUM>. After the puncture site <NUM> is sealed, the guide wire <NUM> can be removed as shown in <FIG>. As the guide wire <NUM> is removed, the suture <NUM> remains in tension and the user can recompress the plug <NUM> with the tamper <NUM> as desired to confirm a proper seal of the puncture site <NUM>. Once properly sealed, the suture <NUM> can be cut so that the remaining suture <NUM>, tamper <NUM>, and other components of the sealing device <NUM> can be removed from the puncture site <NUM>, as shown in <FIG>. Remaining portions of the sealing device <NUM>, including the toggle <NUM>, plug <NUM>, portion of suture <NUM>, and locking member <NUM> (depending on material used) will resorb into the body of the patient over time.

While the foregoing description and drawings represent the preferred embodiment of the present invention, it will be understood that various additions, modifications, combinations and/or substitutions may be made therein without departing from the scope of the present disclosure as defined in the accompanying claims. In particular, it will be clear to those skilled in the art that the present disclosure may be embodied in other specific forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the essential characteristics thereof. One skilled in the art will appreciate that the present disclosure may be used with many modifications of structure, arrangement, proportions, materials, and components, which are particularly adapted to specific environments and operative requirements without departing from the principles of the present disclosure. In addition, features described herein may be used singularly or in combination with other features. For example, features described in connection with one component may be used and/or interchanged with features described in another component. The presently disclosed embodiment is therefore to be considered in all respects as illustrative and not restrictive, the scope of the present disclosure being indicated by the appended claims, and not limited to the foregoing description.

Claim 1:
A vascular closure device (<NUM>), comprising:
a deployment assembly (<NUM>) that is elongate along a longitudinal direction and that has a distal end and a proximal end spaced from the distal end in a proximal direction that is aligned with the longitudinal direction;
a sealing unit (<NUM>) carried by the deployment assembly (<NUM>), the sealing unit (<NUM>) including a suture (<NUM>) coupled to the deployment assembly (<NUM>);
a tamper (<NUM>) carried by the deployment assembly (<NUM>) and disposed along the suture (<NUM>) with respect to the sealing unit (<NUM>) in the proximal direction, the tamper (<NUM>) including a lumen that receives the suture (<NUM>) such that the tamper (<NUM>) is slidable along the suture (<NUM>); and
a locking assembly (<NUM>) configured to selectively inhibit advancement of the tamper (<NUM>) along the suture (<NUM>) in the distal direction toward the sealing unit (<NUM>), wherein the locking assembly (<NUM>) is adapted to transition from A) a locked configuration where the tamper (<NUM>) is inhibited from sliding along the suture (<NUM>), into B) an unlocked configuration where the tamper (<NUM>) is slidable along the suture (<NUM>) in the distal direction and into contact with the sealing unit (<NUM>),
characterized in that the locking assembly (<NUM>) is coupled to the tamper (<NUM>), and the locking assembly (<NUM>) includes a lever (<NUM>) coupled to a tensioning element (<NUM>), the lever (<NUM>) including an engagement end (<NUM>), wherein when the locking assembly (<NUM>) is in the locked configuration the engagement end (<NUM>) is disposed in a notch (<NUM>) in the tamper (<NUM>) such that the tamper (<NUM>) is inhibited from sliding along the suture.