Patent Description:
<CIT> (hereinafter, the '<NUM> patent), entitled Hemostatic Puncture Closure System and Method of Use, discloses systems for sealing a percutaneous incision or puncture in a blood vessel. The systems of the '<NUM> patent comprise a closure device, an introducer, and a deployment instrument including a carrier for the closure device. The closure device has three basic components, namely, a sealing member, an intra-arterial anchor, and a positioning member.

The sealing member is in the form of an elongate, rod-like plug, e.g., a compressed hemostatic, resorbable collagen sponge or foam. This plug member is arranged for sealing the puncture. The anchor is an elongate, stiff, low-profile member which is arranged to be seated inside the artery against the artery wall contiguous with the puncture. The anchor is molded of non-hemostatic resorbable polymer similar to conventional resorbable sutures.

The positioning member comprises a filament, e.g., a resorbable suture. The filament connects the anchor and the collagen plug (sealing member) in a pulley-like arrangement, and includes a portion extending outside the patient's body. The outwardly located filament portion is arranged to be pulled, i.e., tension applied thereto, after the anchor is located within the interior of the artery and in engagement with the inner wall of the artery contiguous with the incision or puncture. The pulling on the filament causes its pulley arrangement to move the plug in the puncture tract toward the anchor. A tamper forming a portion of the deployment instrument is slid down the filament while the filament is maintained in tension to gently tamp the plug in the puncture tract to cause the plug to deform so that its diameter increases. Tension is maintained on the filament by use of an externally located spring during the tamping procedure.

The expansion of the plug within the tract is enhanced by the fact that it is formed of a compressed collagen so that it expands in the presence of blood within the puncture tract. The expansion of the plug within the puncture tract serves to hold it in place. Moreover, the closure device quickly becomes locked in place through the clotting of the hemostatic collagen plug within the puncture tract. The spring serves to hold the plug in its deformed state until such time that the plug is locked in place by the hemostatic clotting action. Once this has occurred, so that the plug is effectively locked within the puncture tract, the externally located spring can be removed. This typically occurs after approximately <NUM> minutes. After the spring is removed, the filament is severed at the top of the tamper. The tamper is then removed and the remaining portion of the filament is cut subcutaneously prior to the discharge of the patient. The portion of the filament connecting the anchor to the plug remains in tension, thereby holding the closure device permanently in place until it is eventually absorbed by the patient's body.

<CIT> (hereinafter, the '<NUM> patent), entitled Self-locking Closure for Sealing Percutaneous Punctures, also teaches systems for sealing a percutaneous incision or puncture in a blood vessel. <CIT>, hereinafter the '<NUM> patent, entitled Hemostatic puncture closure system and method of use, discloses a system, closure, and method of use for determining the position of a blood vessel via a percutaneous puncture and for sealing the percutaneous puncture in the blood vessel. <CIT>, hereinafter the '<NUM> patent, entitled Plug device with pulley for sealing punctures in tissue and methods of use, discloses an instrument, a closure, and method of use for sealing an opening, e.g., a percutaneous incision or puncture, in a living being. <CIT>, hereinafter the '<NUM> publication, entitled Vascular puncture seal anchor nest, discloses a method and apparatus for sealing a subcutaneous tissue puncture that increases the reliability of device function by creating a multilevel anchor nest in a carrier tube of a tissue puncture closure device. <CIT>, hereinafter the '<NUM> publication, entitled Rapidly eroding anchor, discloses an anchor for using a closure device that includes a body being configured to move from a pre-deployed state to a deployed state. <CIT>, hereinafter the '<NUM> publication, entitled Method and apparatus for soft tissue fixation, discloses a positioning member released to move an anchor member to a holding position. The positioning member is operable to be held in a selected orientation until the anchor member is in a selected position. <CIT>, hereinafter the '<NUM> publication, entitled Vascular hole closure device, discloses a device for closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall. <CIT>, hereinafter the '<NUM> publication, entitled Vascular hole closure device, discloses a device for closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall.

The present invention is defined in and by the appended claims. According to an aspect, there is a deployment instrument for sealing a percutaneous puncture in a wall of a body passageway, the deployment instrument comprising a closure device configured to seal the percutaneous puncture in the wall of a body passageway, the closure device configured to permit a guidewire to pass therethrough; and a carrier assembly configured to hold the closure device in a pre-deployment state.

The methods described in the present disclosure are not claimed.

Examples of the present disclosure are described herein with reference to the attached drawing sheets in which:.

The disclosure is directed towards wound (puncture) closure devices, systems and methods, and wound (puncture) closure device deployment instruments and methods and systems of utilization thereof, associated with closing a relatively large puncture (wound) of an artery, such as by way of example, a femoral artery. Such a large puncture may exist as a result of a balloon aortic valvulopasty (BAV) and/or percutaneous aortic valve replacement (PAVR) procedure and/or a related procedure, which utilize access sheaths from the <NUM> to 24F size. Hereinafter, these procedures (BAV, PAVR and related procedures) may be referred to as the "referenced vascular treatment procedures.

An exemplary embodiment of the wound closure system detailed below and some variations thereof interface with an intravascular guide wire. Accordingly, some exemplary embodiments of use of thereof will first be detailed, followed by a discussion of some specific features to the wound closure system of some exemplary embodiments.

In an exemplary embodiment, a needle cannula usable in a valvulopasty and/or percutaneous aortic valve replacement procedure is inserted into an artery. Such a needle may correspond to, by way of example and not by way of limitation, a needle usable in the Seldinger method.

While the needle cannula is in place (extending into the artery), a guide wire is passed through the cannula of the needle a desired distance into the artery (sufficient for the teachings detailed herein and/or variations thereof to be practiced, and/or other procedures to be practiced). In an exemplary embodiment, the guide wire is a so-called <NUM> millimeters (thirty-five thousandths of an inch) guide wire. In an exemplary embodiment, the guide wire is an access guide wire). Once the guide wire is in place, the needle cannula is removed by pulling the needle away from the artery over the guide wire. This leaves the guide wire in place, with a portion thereof extending the desired distance (or thereabouts) into the artery. This further leaves an incision through which the guide wire extends. As will be detailed below, in an exemplary embodiment, the guide wire is part of a wound closure device deployment instrument, although in other exemplary embodiments, the guide wire is a separate element.

An introducer sheath, such as a large bore sheath, is passed over the guidewire, through the incision and into the artery, as depicted in <FIG>, where element <NUM> is a large bore sheath, element <NUM> is a guide wire, element <NUM> is a femoral artery (depicted in cross-sectional view), element <NUM> is the puncture in the artery (wound in the artery), element <NUM> is the tract leading to the puncture <NUM> and element <NUM> is the skin. By tract it is meant the passageway in the tissue located between the artery <NUM> and the skin <NUM> of the being, and which is formed when the artery is punctured percutaneously.

It is noted that the scene depicted in <FIG> may be achieved through other steps than those just depicted by way of example. Any method or methods that result in the human tissue-medical device interface regime depicted in <FIG> and/or variations thereof, which enable the teachings herein and/or variations thereof and/or result in the utility of the teachings detailed herein and/or variations thereof, may be used in some embodiments. Indeed, the aforementioned actions may be part of or be substituted by actions that are part of the referenced vascular treatment procedures. In any event, after executing such actions, a large bore sheath <NUM> remains in a vessel, such as the common femoral artery, as depicted by <FIG> and/or a variation thereof.

As can be understood by the diagram of <FIG> and attention to the sizing (unless otherwise noted, the drawings herein are drawn to scale), the sheath <NUM> is relatively large in relation to the inner diameter of the vessel (e.g., it has an inner diameter and/or an outer diameter of about. <NUM> and/or. <NUM> or more times the size of the inner diameter of the artery, as measured on a plane lying normal to the longitudinal axes of these tubular structures). In this regard, the sheath <NUM>, as it is a large bore sheath, requires a transverse slit (i.e., a slit extending axially) in the artery which will be relatively large (sufficient to receive the sheath <NUM> therethrough, after the elastic nature of the artery is taken into account).

In an exemplary embodiment, the guidewire <NUM> is utilized for advancement of a wound closure device deployment instrument through the sheath <NUM> in general, and movement of a wound closure device in particular along the guide wire. It is noted that some exemplary details of the deployment instrument and closure device are provided below. However, in some embodiments, the deployment instrument and/or closure device may correspond to the deployment instrument and/or wound closure device of any of the above referenced applications as modified to interface with the large bore sheath <NUM> and/or closure device and/or deployment instrument detailed below, wherein the closure device may correspond to the closure device of any of the above referenced applications as modified to close such a large opening in the artery (e.g., an opening large enough to permit a sheath of 18F to fit through as depicted in the FIGs.

Also shown in <FIG> is a PTA balloon <NUM> inserted proximally or from a contralateral puncture site. This balloon is utilized to block blood flow proximal to the large bore puncture site (i.e., the site depicted in <FIG>), and as an entry for contrast dye. Balloon <NUM> is depicted in an uninflated or semi-inflated state coupled to guidewire <NUM>. In use, inflation fluid is pumped to the balloon, to inflate the balloon <NUM>. It is noted that some embodiments may not include the balloon <NUM> / may not utilize the balloon <NUM>.

An exemplary embodiment of a closure device will now be briefly described in the context of the environment of <FIG>, with some additional details of the closure device being provided further below.

At some point during the aforementioned procedure, the incision in the artery is utilized for whatever medical purposes associated with the utility of the incision. After such utilization, there is utilitarian value in closing the incision. An exemplary embodiment of a closure device for closing the incision will now be described in the context of the artery <NUM>.

<FIG> depicts an exemplary closure device <NUM> closing puncture <NUM>. The closure device <NUM> includes toggle <NUM>, plug <NUM> (often referred to in the art and herein as a sealing member or collagen pad, or simply collagen), lock <NUM>, and suture (also referred to in the art and herein as filament) <NUM>, in the fully deployed state with the suture <NUM> cut below the skin level <NUM> (the occlusion balloon is depicted in the uninflated / deflated condition. <FIG> depicts a cross-sectional view of the artery <NUM>, which details the fit of the toggle <NUM> to the internal diameter of the artery, and also depicts the profile of the toggle <NUM> with respect to the longitudinal axis of the artery <NUM>.

<FIG> and <FIG> depict by way of example the closure unit <NUM> (comprising toggle <NUM>, collagen <NUM>, lock <NUM>, and suture <NUM>) in the fully deployed state with the suture <NUM> cut below the skin level, and the occlusion balloon deflated to re-establish blood flow in the vessel and depict the fit of the toggle <NUM> to the internal diameter of the vessel, highlighting the low profile of the toggle design, as seen along the longitudinal axis of the vessel.

In an exemplary embodiment, the closure device <NUM> can correspond to any of the above referenced applications as modified to close such a large opening in the artery (e.g., an opening large enough to permit a sheath of 18F to fit through as depicted in the FIGs. ) and/or to provide an alternate access pathway if needed during the procedure in which the method is executed.

For example, suture (filament) <NUM> can correspond to filament <NUM> of <CIT>, entitled DEPLOYMENT INSTRUMENT FOR CLOSURE DEVICE FOR PERCUTANEOUSLY SEALING PUNCTURES. Lock <NUM> can correspond to lock <NUM> of the aforementioned '<NUM> application (or any other lock detailed therein and variations thereof). Collagen <NUM> can correspond to plug <NUM> of the aforementioned '<NUM> application, although it is noted that the size of plug <NUM> may vary from that disclosed in the '<NUM> application.

While the toggle <NUM> is different in size and geometry from that explicitly disclosed in the '<NUM> application with respect to that anchor <NUM> detailed therein, in an exemplary embodiment, the toggle <NUM> corresponds to the anchor <NUM> of the '<NUM> application in a modified form in accordance with the teachings detailed herein and/or variations thereof.

In an embodiment, the suture <NUM> is a braided multifilament size <NUM>-<NUM> PLLA suture. The suture <NUM> can be made from any synthetic absorbable plastic material that degrades as needed.

The plug <NUM> comprises a strip of a compressible, resorbable, collagen foam which includes one or more apertures through which portions of the suture <NUM> extend. In an embodiment, the plug <NUM> is a collagen pad made of a fibrous collagen mix of insoluble and soluble collagen that is cross linked for strength. In an embodiment, the collagen may be obtained from the connective tissue of animals. The collagen may be purified from the subdermal layer of cowhide.

The lock <NUM> comprises a cylindrical piece of resorbable iron and/or stainless steel crimped in a manner to provide a limited amount of resistance to movement along the suture <NUM>.

An embodiment of the toggle <NUM> is constructed of a <NUM>/<NUM> polylactic-cogycolic acid or other synthetic absorbable polymer that degrades in the presence of water into naturally occurring metabolites (e.g., water and CO2). In an embodiment, the toggle <NUM> is a monolithic structure formed by a bio-absorbable polymer.

It is noted that the aforementioned closure device <NUM> is an exemplary closure device, and alternate embodiments of such may be used in some embodiments. By way of example only and not by way of limitation, the aforementioned crimped lock may not be present, and instead, the filament is looped and/or suturing is utilized to hold the relative locations of the elements of the closure device <NUM> (e.g., plug <NUM> and toggle <NUM>). By way of example and not by way of limitation, the closure device may correspond to, scaled for application with large bore application or unscaled, that detailed in <CIT> (hereinafter, the '<NUM> patent) and/or variations thereof. Further by way of example and not by way of limitation, the closure device may correspond to, scaled for application with large bore application or unscaled, that detailed in <CIT> (hereinafter, the '<NUM> patent) and/or variations thereof. Any device, system and/or method of closing the puncture that utilizes a component that fits into the artery to provide a reaction element (e.g., toggle <NUM>) against a force applied thereto associated with closing the puncture and/or any device, system and/or method of closing the puncture that utilizes a plug (e.g., collagen plug <NUM>) may be used in some embodiments. In some other embodiments, any device, system and/or method of closing the puncture may be utilized.

An exemplary puncture (wound) of which the teachings detailed herein and/or variations thereof can be utilized to close or otherwise be associated with is a puncture in an artery having a diameter (inner or outer) of about <NUM>, although such teachings can also be applicable to such having a diameter (inner or outer) of about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or about <NUM> or more, or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values). In an exemplary embodiment, the puncture extends over an arc, transverse to a longitudinal axis of the artery (about the circumference normal to the longitudinal axis) of about <NUM> degrees, although in some embodiments, the arc extends <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or about <NUM> degrees, or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values). By way of example, the puncture may extend along an arc having a length of <NUM>, although in some embodiments, the length is about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or about <NUM> or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values).

As noted above, some additional exemplary features of the components that make up the closure device <NUM> are further detailed herein. Prior to that, however, a brief discussion of an exemplary deployment instrument is provided (with additional details pertaining to the deployment instrument being provided further below) for deploying a closure device such as closure device <NUM> and/or other equivalents thereof and/or variations thereof.

<FIG> depicts an exemplary deployment instrument <NUM> according to an exemplary embodiment, configured to deploy the closure device <NUM>. As described herein, deployment instrument <NUM> includes a closure device <NUM> and a guide wire <NUM>. However, in other embodiments, the deployment instrument may not include one or both of these elements.

Briefly, deployment instrument <NUM> is configured to be inserted into sheath <NUM>. Deployment instrument <NUM> includes a release tube <NUM> and a handle <NUM>. Release tube <NUM> is configured to move relative to handle <NUM> and release tube support <NUM> along longitudinal axis <NUM> via actuation of lever <NUM> clockwise or counter-clockwise relative to the handle, as depicted by arrow <NUM>. That is, movement of lever <NUM> moves release tube <NUM> (sometimes referred to herein as restraining tube <NUM>) inward / proximal to release the toggle <NUM>.

More particularly, <FIG> depicts a cross-sectional view of the distal end of the deployment instrument <NUM>, depicting additional components of the deployment instrument <NUM>. As may be seen, deployment instrument <NUM> includes a delivery tube <NUM> that is located within release tube <NUM>. The plug <NUM> of closure device <NUM> is located in the delivery tube <NUM>, with filament <NUM> extending past plug <NUM> to toggle <NUM>. It is noted that plug <NUM> may partially extend outside of tube <NUM>. In an exemplary embodiment, delivery tube <NUM> corresponds to a carrier assembly (which can include only the delivery tube or can include additional components).

As may be seen, toggle <NUM> is located such that it is at least partially located in the release tube <NUM>. In some embodiments, it may be fully located in the release tube <NUM> (i.e., no part of the toggle <NUM> extends past the distal tip of the tube <NUM>. Toggle <NUM> is held in place by filament <NUM>. As will be described in more detail below, guide wire <NUM> extends through delivery tube <NUM> and release tube <NUM>, as well as through toggle <NUM> and/or plug <NUM>. In this regard, <FIG> depicts a top view of the distal end of deployment instrument <NUM>, with <FIG> depicting a side view thereof for comparison purposes. As may be clearly seen in <FIG>, the guide wire <NUM> extends through toggle <NUM> (through the longitudinal center of the toggle <NUM>). In an exemplary embodiment, the association of the guide wire <NUM> with the toggle <NUM> as detailed herein and/or variations thereof can have utility in that such may ensure or otherwise effectively and/or substantially increase the statistical probability (at least with respect to that in the absence of the guide wire association) that the toggle is at least generally if not substantially or about perfectly centered relative to the incision in the artery.

In an exemplary embodiment, irrespective of the presence or absence of the guide wire <NUM>, the plug <NUM> is held within delivery tube <NUM> in a manner that is similar to and/or a manner that is the same as that associated with the plug <NUM> tubular carrier <NUM> of the '<NUM> application.

<FIG> depicts an end view of the deployment instrument <NUM> looking at the distal end thereof.

In operation, movement of lever <NUM> on the delivery handle <NUM> of the deployment instrument <NUM> in the direction of arrow <NUM> moves the release tube <NUM> in the proximal direction to about the location depicted in <FIG> (although the tube <NUM> may be moved to other locations in other embodiments, such as to a more distal location). As may be seen, the toggle <NUM> is now completely outside the release tube <NUM>, and is thus "released.

In an exemplary embodiment, the deployment instrument <NUM> is a fully integrated system that includes the deployment device <NUM> and the guide wire <NUM>. In an exemplary embodiment, it is packaged (in, by way of example, a sterilized manner). In an exemplary embodiment, it is packaged in a hermetically sealed package. The guide wire <NUM> may be wound in a winding with a relatively large radius to avoid kinking the guide wire. <FIG> depicts an exemplary closure device kit <NUM>, including deployment instrument <NUM>, closure device <NUM> and guide wire <NUM> sterilized and hermetically sealed in package <NUM>. In an exemplary embodiment, kit <NUM> may further include an insertion sheath <NUM> in package <NUM> and/or in a separate package attached thereto.

It is noted that in an alternate embodiment, the guide wire <NUM> is not part of the kit and/or the delivery instrument <NUM>. Instead, it is a separate component that is threaded through the toggle <NUM> and/or the plug <NUM> after access to the delivery instrument <NUM> (and thus the closure device <NUM>) is obtained. Accordingly, an exemplary embodiment includes a method whereby a user, such as a physician or an operation room nurse or other professional passes an end of a guide wire through a hole in the toggle <NUM> or otherwise associates the toggle <NUM> with the guide wire, followed by deployment of the closure device <NUM>.

Use of the deployment instrument <NUM> will now be detailed with respect to an exemplary deployment method of deploying the closure device <NUM>.

With the sheath <NUM> in place as seen in <FIG>, the deployment instrument <NUM> is inserted into a proximal end (not shown) of sheath <NUM>, and moved through the sheath <NUM> until the distal end of the instrument <NUM> end extends out of the distal end of the sheath <NUM>, approximately as shown in <FIG>. In an exemplary embodiment, the guide wire <NUM> extends through the deployment instrument <NUM>, and the deployment instrument <NUM> slides along the guide wire <NUM> (guide wire <NUM> and sheath <NUM> are generally held stationary, relative to artery <NUM>, while deployment instrument <NUM> is moved through the sheath <NUM>). In an alternate embodiment, the guide wire <NUM> moves with the deployment instrument <NUM>, at least to a certain extent.

More particularly, <FIG> depicts the relative locations of toggle <NUM>, the end of the delivery tube <NUM>, and the release tube <NUM> of the deployment instrument <NUM> with respect to the distal end of the sheath <NUM>. This positioning is achieved by driving the deployment instrument <NUM> through sheath <NUM>, over the guide wire <NUM> and/or with the guide wire <NUM>, until the release tube <NUM>, along with the closure device <NUM> in general and the toggle <NUM> in particular, as detailed herein and/or variations thereof (where toggle <NUM> and plug <NUM> and some of filament <NUM> is visible in <FIG>), is positioned as shown. The positioning can be determined via the use of one or more radiopaque markers <NUM> and/or <NUM> on the release tube <NUM>. The user, utilizing fluoroscopic methods, can determine the position of radiopaque marker <NUM>, and thus the release tube <NUM>, relative to the end of the sheath <NUM>. In an exemplary embodiment, the user stops driving the deployment instrument <NUM> into the sheath <NUM> upon the marker <NUM> emerging from the sheath <NUM> (imaged using fluoroscopic methods). It is noted that other devices, systems and/or methods may be utilized to determine or otherwise estimate the position of the end of the release tube <NUM> relative to the insertion sheath <NUM>. For example, a channel which permits blood to follow through / along the instrument <NUM> to a location that is visible by the user upon the instrument <NUM> being so positioned may be used in some embodiments. An exemplary embodiment utilizes some and/or all of the teachings associated with determining or otherwise positioning introducer sheath <NUM> and/or device <NUM> of <CIT>. Any device, system and/or method that will enable the position of the instrument <NUM> to be determined or otherwise estimated may be used in some embodiments. In an alternate embodiment, the sheath <NUM> is sized and dimensioned and/or the delivery instrument <NUM> is sized and dimensioned such that movement of the deployment instrument <NUM> through the sheath <NUM> stops at a certain point (e.g., a wall of the deployment instrument <NUM> abuts the sheath <NUM>) such that the distal end of the deployment instrument <NUM> extends a distance past the distal end of the sheath <NUM> a distance having utilitarian value.

As may be seen in <FIG>, the toggle <NUM>, which in this exemplary embodiment, is smoothly shaped, is partially covered by the release tube <NUM> upon its emergence from the sheath <NUM>. Because it is exposed, the smoothness has utility in that it can permit relatively smooth entry into the artery and can allow for rearward movement of the closure device within the artery without risk of the toggle <NUM> catching on any plaque or other obstruction. Given the anatomical nature of the access site and puncture, the release tube <NUM> (and the delivery tube <NUM>, sheath <NUM> and guidewire <NUM> will be slightly curved as may be seen in <FIG>. This curvature provides a biasing force on the toggle <NUM> for the release actions.

Upon positioning of the deployment instrument <NUM> at the desired position relative to the distal end of the sheath <NUM> (i.e., at the position depicted in <FIG>), the lever <NUM> is rotated relative to the rest of the instrument <NUM> in a direction and by a sufficient amount to retract the release tube <NUM> a utilitarian distance relative to delivery tube <NUM>, thereby entirely exposing the toggle <NUM>. <FIG> depicts such an exemplary retraction, with delivery tube <NUM> not shown for clarity. As may be seen, guide wire <NUM> extends through toggle <NUM> after retraction of the release tube <NUM>.

Next, sheath <NUM> is withdrawn from the approximate position depicted in <FIG>. However, prior to this, balloon <NUM> optionally can be inflated as shown in <FIG>. Because the sheath <NUM> may exit the puncture <NUM> when the sheath <NUM> is withdrawn from the artery, the balloon is inflated under a low pressure to block blood flow from a proximal position at least prior to fully withdrawing the distal end of the sheath <NUM> from the artery (where blood flow flows from left to right with respect to the frame of reference of <FIG>).

As just noted the insertion sheath <NUM> is withdrawn from its previous position, either partially and/or fully out of the artery <NUM>. <FIG> depicts withdrawal of the insertion sheath <NUM>. While the sheath <NUM> is withdrawn, the relative position of the deployment instrument <NUM> relative to the artery can change, either by the same amount or by a lesser or greater amount, although in other embodiments, its location relative to the artery may remain the same. Any movement or lack thereof of the instrument <NUM> relative to the artery may exist in some embodiments providing that it does not negate the utilitarian value of the embodiment. Some such movement may be seen by comparing <FIG>. In this regard, <FIG> depicts the deployment instrument <NUM> in general, and the closure device <NUM> carried thereby, in a position relative to the puncture <NUM> having utilitarian value.

It is noted that in an exemplary embodiment, plug <NUM> can be withdrawn from tube <NUM> without contacting the sheath <NUM> and/or at least without contacting the interior of the sheath <NUM>. This may, in some embodiments, eliminate the possibility that the plug <NUM> might become stuck in the sheath <NUM>- during the deployment procedure as it expands once leaving the tube <NUM>.

In an exemplary embodiment, a contrast agent is injected distal to the balloon <NUM>. Contrast agent can indicate any leakage at the puncture site and can additionally provide for an outline of the toggle <NUM> using fluoroscopic methods.

The sheath <NUM> and/or the tube <NUM>, are retracted (moved in the direction that would withdraw them from the patient) until the distal radiopaque marker aligns with the puncture, as will be seen fluoroscopically.

Still referring to <FIG> depicts how the toggle <NUM> will be released from the biased state with retraction of the release tube <NUM>. The release orients the toggle <NUM> parallel to the vessel axis. Release is confirmed by the alignment of the distal radiopaque marker <NUM> with the end of the sheath <NUM> and/or markings on the handle (not shown). Note that vessel occlusion is maintained during this action, and an outline of the toggle will be visible to the user on the fluoroscope (as will be detailed below, the toggle <NUM> may include material that is readily apparent through fluoroscopy. Note further that, in an exemplary embodiment, the contact of the most distal portion of the toggle <NUM> with the artery wall forces the toggle <NUM> to rotate clockwise upon sufficient movement of the release tube <NUM>, thus aligning the toggle <NUM> in a manner that will statistically improve the chances that the toggle <NUM> will be sufficiently aligned so as to statistically reduce the likelihood (at least in comparison to the absence of such alignment), if not substantially eliminate or completely eliminate the likelihood that it will be pulled out of the artery during subsequent actions. It is noted that in some embodiments, radiopaque marker(s) may be located on the sheath <NUM>, such as, by way of example, at the distal end / tip of the sheath <NUM>. Such may be used, in some exemplary embodiments, to determine the position of the sheath <NUM>. For example, a sheath marker may be utilized to determine the position / estimate the position of the distal end of the sheath relative to the puncture. Such may have utility in determining whether or not to further retract the sheath <NUM> from the artery based on the location of the marker. Still further by example, such may be used to determine the location of certain components of the deployment instrument <NUM> (e.g., the release tube <NUM> and/or the deployment tube <NUM>, such as, by way of example, based on radiopaque markers thereon, etc.), relative to the sheath <NUM>.

Next, the delivery instrument <NUM> is moved proximally such that the distal tip thereof is moved from the location depicted in <FIG> to at least about the location depicted in the functional schematic of <FIG> (with sheath <NUM> not shown for clarity). This results in plug <NUM> being completely withdrawn from the artery and toggle <NUM> being drawn closer to the puncture <NUM> and/or substantially or completely against the puncture <NUM>. Guide wire <NUM> may move along with delivery instrument <NUM> partially and/or fully, or may remain stationary while the delivery instrument <NUM> is moved to the location of <FIG> and locations thereabouts. Continued movement of the delivery instrument <NUM> away from the puncture, to a location such as that depicted by way of example in <FIG>, pulls toggle <NUM> closer to the puncture and/or completely against the puncture, and also pulls plug <NUM> out of the delivery tube <NUM> and, as a result of a pulley action / synching action / lassoing action between the filament <NUM>, the toggle <NUM> and the plug <NUM>, the plug is pulled towards the toggle <NUM> and thus the puncture <NUM> (in some embodiments such that it contacts the artery wall), with guide wire <NUM> having the movements or lack of movements detailed above. Below, an exemplary device that has utilitarian value in moving the plug <NUM> relative to the toggle <NUM> is described.

Next, the delivery instrument <NUM> is moved further away from the puncture to expose some additional components therein, such as, for example, a tamper, the lock if not already exposed, and additional filament <NUM> (by exposed, it is meant that the delivery tube <NUM> (or other component of the delivery instrument <NUM>) is pulled past these components such that the components emerge from the distal end of the tube <NUM> (or other component that carries these components)). It is noted that such exposure may be achieved by pulling the handle <NUM> of the delivery instrument <NUM>, which results in pulling of the delivery tube <NUM> (and the release tube <NUM>), and other components.

<FIG> depicts an exemplary result of such movement of delivery instrument <NUM>, where tamper <NUM> has been exposed from the delivery tube <NUM> (not shown in <FIG>, as it is exemplary moved out of the field represented by <FIG>). It is noted that the procedure for exposing the tamper <NUM> and the tamper <NUM> itself may correspond to the teachings of such exposure and the tamper detailed in the '<NUM> patent, the '<NUM> patent and/or the '<NUM> application (although it is noted that below, an alternate tamper and an alternate method of exposure and an alternate device for achieving such exposure is detailed).

More particularly, <FIG> represents by way of example how the retracting the sheath <NUM> and deployment instrument <NUM> can position the toggle <NUM> to cover the interior of the puncture. <FIG> represents how further retraction of the deployment instrument <NUM> will deploy the contents of the delivery tube <NUM>, namely the collagen <NUM>, lock <NUM>, and tamper tube <NUM>, which will allow the user to compress the collagen <NUM> in place and deploy the lock <NUM> (in embodiments that utilize such a lock). In an exemplary embodiment, these components correspond to those disclosed in the '<NUM> patent, the '<NUM> patent and/or the '<NUM> application, and variations thereof, as might be scaled for use to procedures disclosed herein. Moreover, the steps of achieving the results depicted in these FIGs. may include some and or all of the method steps disclosed in any of the '<NUM> patent, the '<NUM> patent and/or the '<NUM>. As noted above and is further detailed below, toggle <NUM> position can be confirmed fluoroscopically.

After utilitarian placement of the plug <NUM> relative to the toggle <NUM> and/or puncture <NUM>, the plug <NUM> is locked in place by tamping lock <NUM> with tamper <NUM> in the distal direction (as represented by arrow <NUM>) as described by way of example in the '<NUM> application. Again, an exemplary device that has utilitarian value in tamping lock <NUM> is described below.

It is noted that in an exemplary embodiment, some or all of the features associated with the methods of delivering the closure device <NUM> (including securing the closure device in place) can correspond to those variously taught in the '<NUM> patent, the '<NUM> patent and/or the '<NUM> application as implemented utilizing the teachings detailed herein in general and/or the teachings applicable to the delivery instrument <NUM> and sheath <NUM> in particular. By way of example, the teachings of the '<NUM> application associated with pulling the plug towards the toggle prior to locking the plug in place may be used in some embodiments.

As detailed above, an exemplary embodiment utilizes a toggle that maintains an association with a guide wire. Some exemplary associations will now be described.

<FIG> depicts an exemplary embodiment of a toggle 30A, which can be in some embodiments a large bore toggle, usable in at least some embodiments herein and methods herein. As may be seen, toggle 30A includes two holes <NUM> through which filament <NUM> may extend, as described in greater detail below. (Additional features of the structural arrangement of the toggle are also described below. ) Toggle 30A may be utilized in an embodiment where there is no association between the toggle and the guide wire.

In an exemplary embodiment, toggle 30A and/or the other toggles detailed herein and/or variations thereof are configured to utilitarianly fit to a <NUM> diameter (interior) artery. The toggle 30A has a curved profile, as may be seen in <FIG>, which depicts both a top view and a side view of the toggle 30A. In an exemplary embodiment, the top profile of the toggle 30A has a generally circular profile having a radius of R1, which can be about <NUM>, in an unrestrained configuration, although in some embodiments, the profile may be a radius of about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or about <NUM>, or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values). It is noted that in an exemplary embodiment, the aforementioned radii encompass a profile that is not exactly circular, but instead is elliptical (hence the use of the term "about", which, as used herein with respect to any teaching herein, unless otherwise noted, does not exclude exact values and the use of about also includes embodiments not so qualified (i.e., includes exact numbers, tolerance as would be understood in the art). In an exemplary embodiment, the toggle has an unrestrained width W1 of about <NUM>, although in some embodiments, the width W1 may be about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or about <NUM>, or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values).

In an exemplary embodiment, the radius R1 and/or the width W1 and/or other pertinent dimensions are such that when applied to a given artery, the wing tips 37A and 37B, as opposed to the longitudinal tips 38A and 38B, which run parallel to the longitudinal axis of the artery) contact the artery wall prior to the center <NUM> of the toggle 30A. In an exemplary embodiment, the toggle 30A is made of elastomeric material and/or is of a material such that, when sized and dimensioned for use, allows the toggle 30A to flex (elastically and/or plastically) such that the radius R1 and/or width W1 decreases slightly (to about the interior diameter of the artery - with or without expansion of the artery (in some cases, the artery is about a zero elasticity tissue, such as may be the case for statistically very elderly patients for a population in the United States of America or Europe)) to conform to or about conform to the interior diameter, upon tensioning of the filament as detailed herein and/or variations thereof. In this regard, the upper surface may be characterized as being slightly less curved and/or slightly flatter than the interior surface of the artery (as taken on a plane normal to the longitudinal axis of the toggle and the artery, which in some embodiments, will be parallel or substantially parallel and/or effectively parallel during application).

In an exemplary embodiment, the longitudinal distance of the toggle 30A (tip 38A to tip 38B) is about <NUM>, although in some embodiments, this distance may be about <NUM>, <NUM>, <NUM>, <NUM><NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or about <NUM>, or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values).

<FIG> depicts an alternate toggle, toggle 30B, which includes a hole <NUM>, as may be seen, which accommodates the guide wire <NUM>. Particularly, guide wire <NUM> extends through hold <NUM>, and hole <NUM> permits guide wire <NUM> to slide or otherwise move therethrough. As may be seen, Hole <NUM> is located at about the lateral center of the toggle 30B (lateral center being on the lateral axis 301B, as may be seen) as well as or in the alternative, centered along the axis of the suture holes <NUM>, which may be slightly offset from the lateral axis 301B.

In an exemplary embodiment, the location of hole <NUM> is different than that depicted in <FIG>. For example, <FIG> depicts hole <NUM> located in the longitudinal center of the toggle 30C (longitudinal center being on the longitudinal axis 301C, as may be seen), and/or, the hole <NUM> is longitudinally in between the holes <NUM> in the toggle. Any placement of hole <NUM> in the toggle that will enable the teachings detailed herein and/or variations thereof to be practiced or otherwise to have utilitarian value may be implemented in some embodiments. Also, in some embodiments, association of the toggle with the guide wire is achieved not by a hole through the toggle, but via a notch on the edge of the toggle, as may be seen in <FIG>, where toggle 30D has a notch <NUM>. Such an embodiment can further include one or more holes through which the guide wire extends. An exemplary embodiment that achieves association with the guide wire and the tamper via a notch that has a C-Shaped cross-section (or other equivalent cross-section that achieves the following functional result) such that the guide wire is "trapped" or otherwise retained therein. For example, if the C-shaped interior of the notch is such that the distance between the ends of the C is less than the maximum diameter of the guide wire <NUM>, the guide wire should be retained therein. Alternatively, the notch exists, but the guide wire is not trapped or otherwise retained in the notch. Any device, system and or method of achieving and/or maintaining an association between the guide wire and the toggle may be practiced in some embodiments detailed herein and/or variations thereof.

In an alternate embodiment, a suture hole may be utilized as a hole to achieve association between the toggle and the guide wire / a hole for the guide wire may be utilized to pass a filament <NUM> therethrough. <FIG> depicts such an exemplary toggle 30E. Such may be achieved by making a suture hole with a larger diameter than that which is would otherwise be the case for association with a suture alone.

<FIG> depicts an alternate embodiment where two holes <NUM> are utilized to respectively associate two guide wires <NUM> with the toggle 30F. Accordingly, such an exemplary embodiment may utilize two guide wires. In some embodiments, three or more guide wires and a corresponding number or different number of association devices (e.g., holes, notches, etc.) are utilized.

<FIG> depicts an exemplary filament <NUM> weave through holes <NUM> of an exemplary toggle 30F, with element <NUM> corresponding to, for example, loop 50A and winding <NUM> as detailed in the '<NUM> application. It is noted that the exemplary embodiment of <FIG> includes a suture hole <NUM> spacing width W2 that is wider than that depicted in the exemplary toggle of <FIG>. In an exemplary embodiment, the holes <NUM> are about <NUM> from one another (W2 equals about <NUM>), although in some embodiments, W2 is about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or about <NUM> or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values). It is noted that the spacing between the holes <NUM> of the toggle of <FIG> correspond to about <NUM>. In an exemplary embodiment, the hole spacing is sized so as to provide sufficient structure that provides utilitarian value with respect to providing sufficient material to react against the tension applied to the filament (e.g., it will not break the toggle during tensioning).

It is noted that the weave depicted in <FIG> is applicable to the toggles detailed above and/or below. In exemplary embodiment, element <NUM> is a collar as detailed in the '<NUM> application. Any device system and or method of achieving the utilitarian value of element <NUM> (e.g., its use as a collar), which can include permitting the loop <NUM> established by filament <NUM> to reduce in diameter (like a lasso or the like) can be used in some embodiments.

<FIG> depicts an alternate embodiment utilizing more than two toggle holes <NUM>. As may be seen, four holes <NUM> are used, through which filament <NUM> is threaded. Such an exemplary embodiment can have utility by improving pulley action for compressing the plug <NUM> (not shown in <FIG>), as compared to that resulting from the configuration of <FIG> and/or <FIG>.

<FIG> depicts an alternate embodiment including a washer (resorbable and/or nonresorbable washer) <NUM> interposed as seen in the loop <NUM> formed with toggle 30A (or any other toggles described herein and/or variations thereof). Such may provide for utilitarian management of the wound / puncture at the access site. In an exemplary embodiment, washer <NUM>, upon deployment of the closure device <NUM>, becomes located between the vessel wall and the plug <NUM> (which is interposed in the loop between the toggle 30A and washer <NUM>, but not shown in <FIG>), or, alternatively, proximally of the plug <NUM>. In an exemplary embodiment, the distance between the holes of the washer <NUM> corresponds to the distance between the holes of the toggle 30A, although in an alternate embodiment, the holes have a different spacing than that of the toggle. (It is noted that the aforemementioned hole spacings for the toggle and/or the washer are centerline to centerline dimensions.

In an exemplary embodiment, the holes of the washer are about <NUM> from one another (W2 equals about <NUM>), although in some embodiments, the distance is about <NUM>, about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or about <NUM> or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values). It is noted that the spacing between the holes <NUM> of the toggle of <FIG> correspond to about <NUM>. In an exemplary embodiment, the hole spacing is sized so as to provide sufficient structure that provides utilitarian value with respect to providing sufficient material to react against the tension applied to the filament (e.g., it will not break the toggle during tensioning).

It is noted that an exemplary embodiment includes a toggle having three holes <NUM> or more holes. In an exemplary embodiment, the three holes are utilized with a threaded double suture.

As noted above, delivery instrument <NUM> includes a tamper <NUM> therein. While some embodiments include a tamper and are otherwise configured according to the tamper of the '<NUM> patent, the '<NUM> patent and/or the '<NUM> application, an exemplary embodiment includes a tamper <NUM> that provides association between the tamper and the guide wire <NUM>, as will now be described.

An exemplary embodiment of tamper <NUM> is depicted in <FIG>, and includes a double-lumen. Specifically, tamper <NUM> includes lumen <NUM>', through which filament <NUM> extends, and lumen <NUM>', through which guide wire <NUM> extends. Lumen <NUM>' is sized and dimensioned, relative to the guide wire <NUM> and the filament <NUM>, to permit movement of the tamper <NUM> relative to the filament <NUM>, and lumen <NUM>', in some embodiments, is sized and dimensioned to permit movement of the tamper relative to the guide wire <NUM>, while in other embodiments, it does not permit movement relative thereto.

<FIG> depicts an alternate embodiment of a tamper, tamper <NUM>, which achieves association with the guide wire via the use of guide wire carriers <NUM>", through which guide wire <NUM> extends, the functional features of tamper <NUM> being the same as and/or similar to that of tamper <NUM>. <FIG> depicts another alternate embodiment of a tamper, tamper <NUM>, which includes guide wire slot <NUM>‴, through which guide wire <NUM> extends, and is retained therein (slidably or otherwise) via bridges <NUM> attached to the body of the tamper, the functional features of tamper <NUM> being the same as and/or similar to that of tamper <NUM>. An exemplary embodiment that achieves association with the guide wire and the tamper does not include the bridges <NUM>, while including the slot. The slot may have a C-shaped cross-section (or other equivalent cross-section that achieves the following functional result) such that the guide wire is "trapped" or otherwise retained therein even in the absence of the bridges <NUM>. For example, if the C-shaped interior of the slot is such that the distance between the ends of the C is less than the maximum diameter of the guide wire <NUM>, the guide wire should be retained therein. Alternatively, the slot exists, but the guide wire is not trapped or otherwise retained in the slot. Any device, system and or method of achieving and/or maintaining an association between the guide wire and the tamper may be practiced in some embodiments detailed herein and/or variations thereof. It is noted that the embodiment of <FIG> can have utility in that it provides a level of safeguard against a user inadvertently gripping the guide wire or the like during tamping, where in an exemplary embodiment, the tamper slides relative to the guidewire during tamping.

<FIG> functionally depicts the environment in which tamper <NUM> is utilized. More particularly, after the delivery instrument <NUM> is withdrawn as detailed above to expose the tamper and the other components, tamper <NUM> is exposed as depicted in <FIG>. In the exemplary embodiment depicted in <FIG>, guide wire <NUM> and filament <NUM> extend through respective lumens <NUM>' and <NUM>'. (<FIG> depicts a cross-section of tamper <NUM> taken at line A- A- of <FIG>, where the guide wire <NUM> and the filament <NUM> have been removed for clarity.

In an exemplary embodiment, the tamper <NUM> (or <NUM> or <NUM> or variations thereof) enables tamping action over/along the guide wire <NUM> and suture <NUM>, running through separate lumens <NUM>' and <NUM>' in the double lumen tamper, until the tamper <NUM> contacts the lock <NUM>. Upon contact, the user pushes down (continues to push down) on the lock <NUM> to compress the plug <NUM> in place / to lock the already compressed plug <NUM> in place (such as is done by way of example and not by way of limitation, as detailed in the '<NUM> patent, the '<NUM> patent, the '<NUM> application, at least with respect to movement along the filament thereof), without affecting the placement of the guide wire <NUM>. The double lumen tamper <NUM> enables utilitarian support of the guide wire <NUM>, as compared to the absence of the lumen for the guide wire (or the absence of the alternate components to achieve association with the guide wire) during the deployment of the device and and/or can statistically improve user experience when tamping as compared to tamping without such an association feature.

<FIG> functionally depicts an alternate embodiment of a delivery instrument <NUM>. It is noted that some and/or all of the additional features (e.g., the tensioner apparatus, described below) described with respect to instrument <NUM> may be included in instrument <NUM>. It is further noted that an exemplary embodiment of deployment instrument <NUM> includes some or all of the features of instrument <NUM> detailed above.

Briefly, movement of the release tube <NUM> relative to the delivery tube <NUM> is achieved by applying force to section <NUM> of the release tube <NUM> in the proximal direction of the deployment instrument <NUM>, as indicated by arrow <NUM>, while applying a reaction force to the delivery tube <NUM> at section <NUM> in the direction of arrow <NUM>. Application of sufficient force thereto drives the release tube <NUM> towards the proximal end of the instrument <NUM>, and moves it relative to the deployment tube <NUM>, until section <NUM> abuts section <NUM> or until the force is reduced / eliminated. In this regard, the exemplary embodiment of <FIG> is such that there is a slight friction fit between the tubes <NUM> and <NUM>, although in an alternate exemplary embodiment, the fit is a slip fit. Alternatively or in addition to this, additional components, such as an O ring or the like, may be interposed between the tubes to generate a modicum of friction. Any device system and/or method of moving the tubes relative to one another may be practiced in some embodiments.

In an exemplary embodiment, aside from the different mechanisms utilized to move the tubes relative to one another, the functionality of the deployment instrument <NUM> corresponds to that of the deployment instrument <NUM>, as well as its use.

An exemplary embodiment includes a device, system and/or method of gauging or controlling the application of tension on filament <NUM> while deploying the closure device <NUM> described herein. Specifically, the application of high tension on filament <NUM> may result in the toggle pulling out. Alternatively, insufficient tension will not compress the plug <NUM> onto the exterior vessel wall.

Prior to describing an exemplary embodiment of a tensioner assembly of the delivery instrument <NUM>, some actions associated with deployment of the closure device <NUM> by the deployment instrument <NUM> will be briefly described (some of which includes redescription and/or variations of the description above) in the context of the function of the tensioner assembly.

As detailed above, movement of the deployment instrument <NUM> in the proximal direction causes toggle <NUM> to engage the artery wall. As the toggle <NUM> catches / engages, resistance will be felt by the user with increased movement of the deployment instrument <NUM> in the proximal direction.

With increased movement of the deployment instrument <NUM> away from the puncture, the plug <NUM> is deployed into the puncture tract with the toggle <NUM> engaging or catching the inner surface of the artery wall contiguous with the puncture. The instrument <NUM> is then pulled further outward. Inasmuch as the toggle <NUM> trapped against the interior of the artery wall, the continued retraction of the deployment instrument <NUM> causes the filament <NUM> to pull the plug <NUM> out of the delivery tube <NUM> of the deployment instrument <NUM> and into the puncture tract. As the deployment instrument comes out of and/or is moved further away from the puncture tract, continuous steady resistance will be felt as the tensioner assembly of the deployment instrument controls the force on the filament <NUM> during the retraction procedure.

Continued retraction of the instrument <NUM> brings the tamper <NUM> out of the distal end of the deployment instrument <NUM> (thus exposing the tamper <NUM>).

The retraction of the deployment instrument <NUM> carries the plug <NUM> into engagement with the exterior of the artery wall immediately adjacent the puncture. Continued retraction causes the filament <NUM> to deform the plug <NUM>, i.e., cause it to deform radially outward, in an exemplary embodiment, as detailed by way of example in the '<NUM> patent, the '<NUM> patent and/or the '<NUM> application. In an embodiment, the plug <NUM> (which may be a collagen pad, as noted above) is forced to fold down after exiting the delivery tube <NUM> (in some embodiments, it begins to fold down immediately upon exiting the delivery tube <NUM>). The existence of blood within the puncture tract can further contribute to the deformation of the plug <NUM>, because, in some embodiments, it is collagen foam that expands and softens in the presence of blood. The retraction procedure continues to pull the deployment instrument <NUM> up the filament <NUM> until the user stops pulling. At this point the plug <NUM> should be located in the puncture tract contiguous with the opening in the artery, and the lock <NUM> (if utilized) located immediately proximally of the plug.

The plug <NUM> is now ready to be positioned in the tract. To achieve that end, the user compacts the plug <NUM> by gently tensioning the filament by, for example, pulling on the handle <NUM> of the delivery instrument <NUM> in the proximal direction with one hand. This moves loop element <NUM> down along the filament as a result of tension on filament. Here, toggle <NUM> acts in an analogous manner to a pulley as described in, for example, the '<NUM> application. This has the effect of tightening the loop
<NUM>. As element <NUM> moves down filament section to tighten loop <NUM>, it compacts plug <NUM>. This forces plug <NUM> to conform to the artery contiguous with the puncture in the artery.

Next, the tamper <NUM> is manually slid down the filament <NUM> by the user's other hand so that it enters the puncture tract and engages the proximal side of the lock <NUM>, if present. A force is applied to tamper <NUM> sufficient to overcome the resistance to movement of the lock <NUM> relative to the filament, at least if the lock <NUM> corresponds to the lock of the '<NUM> application. This causes the lock <NUM> to slide down filament section until it abuts element <NUM>. An exemplary embodiment of the lock <NUM> is configured, when used in conjunction with filament <NUM>, to provide a certain amount of resistance to movement along filament <NUM>. This locks element <NUM> in place, as, for example, taught in the '<NUM> application, thus preventing loop <NUM> from expanding. This feature causes the plug <NUM> to be secured in the compact position until hemostasis occurs (which happens relatively very quickly, thereby locking the closure device in place). That is, because the plug <NUM> is compressed between the toggle <NUM> and the lock <NUM>, plug <NUM> is retained or locked in position within the puncture tract and cannot move away from the toggle, even before the blood clots in the plug.

In an exemplary instrument the deployment instruments detailed herein and/or variations thereof include a tensioner assembly. Such a tensioner assembly will be described in terms of deployment instrument <NUM>, but are readily applicable to deployment instrument <NUM>, as will now be described.

<FIG> depicts a cross-sectional view of deployment instrument <NUM>, including tensioner assembly <NUM> in the form of a tensioner cartridge <NUM>. Tensioner cartridge <NUM> configured to gauge / measure and/or to control the forces (e.g., tension in filament <NUM>) resulting from deployment of closure device <NUM>. The tensioner cartridge <NUM> provides the user with visual and/or tactile and/or auditory feedback during deployment. The construction of the tensioning cartridge includes a spring <NUM> located inside a retractable tube <NUM> that allows for the passage of filament <NUM> therethrough. The cartridge <NUM> includes a retractable member <NUM>. In an exemplary embodiment, the retractable member <NUM> is fixedly attached to the filament <NUM>, such that tension on the filament <NUM> imparts a force onto the retractable member <NUM>, and thus spring <NUM>. In an alternate embodiment, the filament <NUM> is attached to one or more of the coils of spring <NUM> (e.g., the most proximal coil / last coil), such that tension on the filament <NUM> imparts a force onto the spring <NUM>. In an alternate embodiment, the retractable member <NUM> may include a soft tensioning member <NUM> through which the filament <NUM> extends. The tensioner assembly <NUM> one or more utilitarian functions. For example, it controls the force applied to the filament <NUM> (and thus the tension) by holding the filament taut during pull back of the instrument <NUM> (or <NUM>) while providing a system for allowing the user to guard against the application of too much force. By utilizing the tensioner assembly <NUM> as detailed below, a user may apply adequate filament tension for compressing the plug <NUM> and/or during tamping the lock <NUM> or other component.

The tensioner assembly may also provide tactile and/or visual and/or auditory indication for the user to stop pulling back and/or to stop applying additional (increasing) force to the deployment instrument in the distal direction when the end of suture length has been reached through change in color, shape, etc., visible on the instrument. In an exemplary embodiment, this can prevent or otherwise enable safeguarding against excessive force being applied to the toggle, preventing the toggle from pulling out of the blood vessel.

During use, application of a force onto deployment instrument <NUM> that results in a first tension on the filament is sufficient to withdraw the cartridge <NUM> out of the delivery tube <NUM>, exposing the cartridge <NUM> such that the user may handle the cartridge <NUM> with his or her hand. In particular, cartridge <NUM> is carried within delivery tube <NUM> such that there is a slight friction fit between the two components. This may be achieved, by way of example, via, elastomeric O- ring <NUM>, as may be seen. Application of the first tension (by applying a sufficient withdrawal force on the instrument <NUM> in the proximal direction) is sufficient to overcome the friction forces and pull the cartridge <NUM> out of the tube <NUM>. Alternatively or in addition to this, a snap fit is utilized to retain the cartridge, and a sufficient force applied to the instrument resulting in sufficient tension on the filament is sufficient to release the snap fit. In yet another alternative embodiment, a positive retention mechanism, such as an actuating cylinder or box beam, etc., that extends into the tube <NUM>, and thus blocks the cartridge <NUM> until it is moved out of the tube <NUM>, or at least from in front of the cartridge <NUM>, may be utilized to retain and then release the cartridge. Any device, system and/or method that can provide the modicum of friction between the cartridge <NUM> and the delivery tube <NUM> and/or that provides the modicum of securement so as to releasably retain the cartridge <NUM> in the delivery tube <NUM> until it should be exposed can be utilized in some embodiments. In this regard, it is noted that the first tension may vary between embodiments. By way of example, the tension associated with overcoming the friction fit utilizing, for example, the O-ring, may be different from that associated with overcoming the snap-fit. Moreover, the tension may be variable or generally constant. For example, the tension during withdrawal of the cartridge <NUM> from the delivery tube <NUM> will be generally constant during the withdrawal process with respect to the friction fit utilizing the O-ring, whereas the tension may vary during withdrawal with respect to the snap-fit or the like. Embodiments where the tension is relatively constant, or at least moderately increases within a range that does not result in damage to the artery wall and/or dislodgement of the toggle, can have utility in that this results in a tension that generally maintains the toggle in place against the puncture on the interior of the artery.

With respect to the embodiment of <FIG>, where the O-ring results in a friction fit between the tube <NUM> and the cartridge <NUM>, application of the first tension results in the ejectment / exposure of the cartridge <NUM>. This is schematically represented by way of example in <FIG>. Upon sufficient exposure of the cartridge <NUM>, the user grips the cartridge <NUM> with a free hand and gradually or abruptly begins to apply force to the cartridge in the proximal direction at a level that is in equilibrium, in an exemplary embodiment, to that applied to the instrument <NUM>, until the cartridge <NUM> is completely free of the delivery tube <NUM>, at which point the tension in the filament <NUM> is a result of force applied to the cartridge <NUM> in the proximal direction.

An exemplary embodiment of the present invention includes a deployment instrument <NUM> including an exemplary tensioner assembly <NUM> as may be seen conceptually in <FIG>. In an exemplary embodiment, the tensioner assembly <NUM> conceptually corresponds to the cartridge <NUM> detailed above, although as will be detailed below, in an exemplary embodiment of the cartridge <NUM>, there are different features between the two.

A portion of the procedure involving deployment of the closure device <NUM> in a recipient using the exemplary tensioner assembly <NUM> of <FIG> will now be described. As may be seen in <FIG> and <FIG>, the tensioner assembly <NUM> includes a frame <NUM> in which a hub assembly <NUM> is slidably retained. Frame <NUM> includes protrusions <NUM> that interact with O-ring <NUM>. In this regard, frame <NUM> corresponds to element <NUM> of <FIG>. The frame <NUM> serves as a handle that the user may grasp during application of the closure device <NUM> to the recipient. In some embodiments, the handle is provided with knurling or tread grips or the like to facilitate grasping by the user. The hub assembly <NUM> includes a hub <NUM> and a tensioner insert <NUM>. The hub assembly is spring loaded by spring <NUM> (which corresponds to spring <NUM> of the device of <FIG>) in the proximal direction of the deployment instrument <NUM>. That is, with respect to <FIG>, the spring <NUM> forces the hub assembly <NUM> upward, relative to the frame <NUM>. Another way of describing this is that the spring <NUM> forces the frame <NUM> to the downward, relative to the hub assembly <NUM>.

It is noted that alternate embodiments include structure that is different from that detailed herein. Indeed, a visual comparison between the embodiment of <FIG> and that of <FIG> reveals that there are differences. It is thus again noted that the structure detailed herein is exemplary and conceptual, and can and/or will vary in implementation. In this regard, while the embodiment of <FIG> depicts a hub <NUM> that extends into the interior of spring <NUM>, the embodiment of <FIG>. Hub <NUM> corresponds to retractable member <NUM> of <FIG>. However, retractable member <NUM> does not so extend into the spring <NUM>, as may be seen.

In an exemplary embodiment, the spring <NUM> permits the tension on filament <NUM> to be controlled / ensures that sufficient tensioning and not too much tensioning is applied to the filament during deployment of the closure device <NUM>, as will now be detailed.

Referring to <FIG>, the tensioner assembly <NUM> includes a filament recess between the tensioner insert <NUM> and a filament cap <NUM> in which filament <NUM> is wound in a coil section 80E, from which the filament <NUM> travels to the closure device <NUM>. The end of the filament 80E is threaded through a hole 1240A in the filament cap <NUM> and is trapped between the filament cap <NUM> and a filament lock <NUM> to hold the end of the filament <NUM> in place. Filament lock <NUM> may be held to filament cap <NUM> via a screw fit or a snap fit or through the use of an adhesive or a weld, etc. That said, in an alternate embodiment, the filament <NUM> extends completely from one side of the hub <NUM> (or the retractable member <NUM>) to the other side thereof, and further proximally out of the frame <NUM> (or element <NUM>).

As may be seen in <FIG>, a friction block <NUM> is located in a cut-out section of the tensioner insert <NUM>. In an exemplary embodiment, the friction block <NUM> is a silicon block that is dimensioned such that when inserted in the hub <NUM> along with tensioner insert <NUM>, a compressive force on filament <NUM> is applied by the friction block <NUM> and the hub <NUM>. In some exemplary embodiments, as will be described in greater detail below, as the filament <NUM> (filament from section 80E) is drawn from the spool of the tensioner assembly <NUM>, the user feels a relatively constant resistance and/or a relatively consistent resistance as compared to other deployment instruments <NUM> (i.e., the resistance felt with one deployment instrument <NUM> used during a given procedure will be about the same as that felt during a prior procedure with another deployment instrument <NUM>). That is, the friction block <NUM> in combination with the tensioner insert <NUM> and hub <NUM> function to control the force required to at least initially withdraw the filament <NUM> from the spool.

In an exemplary embodiment, friction block <NUM> corresponds to soft tensioning member <NUM> detailed above with respect to <FIG>. As has been noted above, the specific structure of various embodiments can vary, while utilizing the principles detailed herein.

As noted above, a force applied to deployment instrument <NUM> sufficient to result in a first tension in the filament can result in the cartridge <NUM> (or tensioner assembly <NUM>) being exposed (withdrawn/released from inside delivery tube <NUM>). As noted above, inasmuch as the toggle <NUM> is trapped (anchored) against the interior of the artery wall, the continued retraction of the deployment instrument <NUM> causes the filament <NUM> to pull the plug <NUM> out of the deployment tube <NUM> of the deployment instrument <NUM>. Also, once the toggle <NUM> catches on the wall of the artery, the filament <NUM> (filament from section 80E or other location where the filament is stored) will be drawn from the spool of the tensioner assembly <NUM>. Some resistance will be felt, at least in embodiments utilizing the friction block <NUM> (or its corresponding structure <NUM>) described above (as opposed to other embodiments where no drag force is applied to the filament as a result of compression of the filament by the friction block, such as in the case where no friction block <NUM> / structure <NUM> is used and a bore or other space of the tension insert <NUM> through which the filament <NUM> passes is oversized relative to the filament <NUM>). This resistance may require the user to apply about <NUM>/4ths of a pound of force to the deployment instrument <NUM> to pull the filament <NUM> out of / through hub <NUM> / structure <NUM>. The user continues to pull the deployment instrument <NUM> away from the recipient with a force sufficient to overcome the friction resulting from the compressive force applied to the filament <NUM> by the friction block <NUM>. At a given distance of the deployment instrument <NUM> from the recipient / from the puncture, the filament <NUM> will be completely unwound from the spool (or otherwise withdrawn through structure <NUM> until stop <NUM> strikes structure <NUM> in the case of cartridge <NUM>). <FIG> depicts the tensioner assembly <NUM> in the state where the filament <NUM> is about <NUM>/<NUM> way unwound from the spool and <FIG> depicts the tensioner assembly <NUM> in the state where all of the filament <NUM> has been unwound from the spool. The tension on filament <NUM> is high enough to unwind the filament from the spool, and potentially compresses spring <NUM> by a corresponding amount.

At this point, with increasing force applied to the deployment instrument <NUM>, the tension in filament <NUM> reaches a high enough value (the first amount detailed above) to overcome the friction forces between the O-ring and delivery tube <NUM>, and thus the cartridge <NUM> (or tensioner assembly <NUM>) becomes exposed exposed (withdrawn/released from inside delivery tube <NUM>).

At this point, the user grips the cartridge <NUM> or frame <NUM>, and continues to withdraw the cartridge <NUM> or frame <NUM> away from the recipient with a steady or increasing force. When the tensioner assembly <NUM><NUM> is located a first linear distance from the vessel wall, because the end of the filament <NUM> (or other part of the filament <NUM>) is trapped between filament cap <NUM> and the filament lock <NUM> (or element <NUM> abuts structure <NUM>), continued pulling of the tensioner assembly away from the recipient (past the first distance), when the user holds the frame <NUM> (or element <NUM>) causes the filament <NUM> to become more tensioned because the "unwinding" of the filament <NUM> from the spool has stopped (there is no more filament from section 80E to be unwound) and the end of the filament <NUM> is held in place as it is attached to the tensioner assembly. Accordingly, this increase in tension as the user moves the deployment tensioner assembly from the first distance from the vessel wall causes frame <NUM> (or element <NUM>) to move relative to hub assembly <NUM> and thus causes spring <NUM> (or spring <NUM>) to compress or further compress. The force compressing the spring is substantially equal to the tension in the filament <NUM>. As the tension of the filament <NUM> progressively increases as the user continues to pull the tensioner assembly <NUM> away from the recipient (via pulling on the frame <NUM> or element <NUM>), the spring <NUM> continues to be compressed, thus resulting in a gradual increase in the tension of the filament <NUM> as the tensioner assembly is continued to be pulled away from the recipient. This as compared to the relatively sudden increase in tension that would exist if the hub assembly <NUM> were instead rigidly fixed to the tensioner assembly <NUM> and/or the spring <NUM> were not present (or if structure <NUM> were instead rigidly fixed to the tensioner assembly <NUM> and/or the spring <NUM> were not present. In this regard, the spring <NUM> / spring <NUM> provides a dampening or cushioning effect with respect to the force applied to the inner wall of the blood vessel or other body passageway which reacts against the toggle <NUM> at the time that the filament <NUM> is fully unwound from the spool. Thus, there should be no sudden increase in the force /pressure on the wall at the location of the toggle <NUM>. Instead, there should be a gradual increase in the force / pressure on the wall at the location of the toggle <NUM>. In an exemplary embodiment, the hub assembly <NUM> may travel about eight (<NUM>) millimeters upon the application of about two (<NUM>) pounds of tension force in the filament <NUM> before bottoming out (i.e., the hub assembly <NUM> cannot move further downward / frame <NUM> cannot move further to the upward with respect to <FIG>). Thus, an embodiment provides a mechanically induced increasing tension force applied to the filament that increases with increasing distance of the tensioner assembly away from the puncture at a rate of less than about <NUM> pounds per <NUM> of increased distance of the deployment instrument away from the puncture. Accordingly, in an exemplary embodiment, pulling the tensioner assembly away from the puncture while the filament is connected thereto results in an initial contact of the anchor to the wall of the body passageway followed by a gradual increase in pressure applied to the wall by the anchor while tension in the filament is less than about two (<NUM>) pounds. Thus, via a mechanical device of the deployment instrument <NUM>, a sudden increase in pressure applied to the wall of a body passageway by the toggle <NUM> is avoided.

<FIG> depicts spring <NUM> fully compressed upon the application of two (<NUM>) pounds of tension force in the filament <NUM> by the user while filament <NUM> is connected to toggle <NUM> (which, as noted above, is lodged in the artery). By bottoming out the hub assembly <NUM>, and not pulling on the tensioner assembly too much more after that, the user can ensure that he or she has applied about two (<NUM>) pounds of tension force on the filament <NUM>, and not too much more. This ensures that sufficient tension has been applied to the filament to properly deploy the closure device <NUM>, and not too much more. Also, the spring <NUM>/ spring <NUM> at least partially reduces what otherwise might be a spike in the force applied to the wall of the artery upon the filament <NUM> becoming completely unwound from the spool and becoming unslackened due to movement of the tensioner assembly away from the recipient.

In an exemplary embodiment, the user feels / senses the gradual increase in tension as the spring <NUM> / spring <NUM> is compressed (as compared to the relatively static tension resulting from friction block <NUM> / element <NUM>), and thus is provided an indication that the tensioner assembly will soon reach the mechanical limits of its withdrawal away from the recipient, after which any further withdrawal will be due to the plastic and/or elastic nature of the filament and the recipient. In some embodiments, the spring <NUM> is a linearly compressible spring, and thus the gradual increase in tension as the spring <NUM> is compressed is linear. Non-linear compressible springs may also be used, in which case the gradual progressive increase in tension is not linear. In an exemplary scenario of use, the user continues pulling the tensioner assembly away from the recipient until the spring <NUM> / spring <NUM> bottoms out, and then halts further movement of the tensioner assembly away from the recipient. Alternatively, the user can continue to pull the tensioner assembly away from the recipient, thereby further increasing the tension in the filament <NUM>. Even with respect to this latter scenario, the indication afforded to the user by the spring <NUM> / spring <NUM> provides the user with an opportunity to adjust the deployment procedure to avoid injury to the recipient and/or damage to the closure device, etc..

It is noted that as the tensioner assembly <NUM> is pulled away from the recipient, and by the time that the spring <NUM> has bottomed out, the pulley arrangement of the filament <NUM> connecting toggle <NUM> and the plug <NUM> causes the plug <NUM> to be moved into engagement with the exterior of the artery wall contiguous with the puncture. The tension in the filament <NUM> resulting from pulling the tensioner assembly away from the recipient causes the filament <NUM> to somewhat deform the plug, i.e., cause it to deform radially outward and, in some embodiments, twist. Because the spring <NUM> / spring <NUM> permits the tension on filament <NUM> to be controlled / ensures that sufficient tensioning and not too much tensioning is applied to the filament during deployment of the closure device <NUM>, the user is provided with some reassurance that the proper amount of tensioning has been applied to the filament <NUM> to deform the plug and properly deploy the closure device <NUM>.

It is noted that an exemplary embodiment includes an indicator that provides an indication to the user that the hub assembly <NUM> has bottomed out within the frame <NUM> (or corresponding structure). In an exemplary embodiment, the indicator corresponds to, at least conceptually and/or functionally, to the indicator taught in the '<NUM> application.

Accordingly, in an example, referring to the flowchart of <FIG>, there is a method of sealing a percutaneous puncture in a wall of a body passageway, comprising, at step <NUM>, providing a deployment instrument <NUM> including a tensioner assembly <NUM> / <NUM> and carrying a closure device <NUM>, the closure device <NUM> including a toggle, a plug <NUM> and a contiguous elongate filament <NUM> configured to draw the plug <NUM> towards the toggle <NUM> upon the application of tension to the filament <NUM> in a direction away from the toggle <NUM>. At step <NUM>, the distal end of the deployment instrument <NUM> is positioned through the puncture into the body passageway such that the toggle <NUM> is located in the body passageway. At step <NUM> the deployment instrument <NUM> is pulled away from the puncture while the filament <NUM> is connected to the deployment instrument. This results in the application of a mechanically induced increasing tension force to the filament <NUM> that increases with increasing distance of the deployment instrument <NUM> away from the puncture, thereby drawing the toggle <NUM> and the plug <NUM> towards each other and into engagement with the wall of the body passageway at respectively opposite sides of the wall. In an exemplary embodiment, the mechanically induced increasing tension force is a result of spring, as detailed above.

<FIG> depicts an embodiment that utilizes two plugs <NUM> and <NUM>', each located on a portion of loop <NUM>, with a single toggle <NUM>. An exemplary embodiment of such a configuration provides utility in that two plugs may better seal a relatively large puncture. In this regard, some punctures will extend a relatively great distance about the artery wall in a direction normal to the longitudinal axis thereof. For example, the puncture may extend over an arc that extends about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM><NUM> and/or about <NUM> degrees or more and/or angles in between these in one degree increments. A single plug may bunch at the apex of the puncture, thus leaving portions of the large puncture exposed on either side of the plug. The use of two plugs covers more area, and thus can cover more of the puncture. By way of example, a single plug may cover a puncture extending over an arc of <NUM> or <NUM> degrees, whereas two plugs may cover a puncture extending over an arc of about <NUM>, or <NUM> or <NUM> or <NUM> or more degrees. Along these lines, the use of two holes <NUM> for the filament spread relatively far apart can space the plugs over the full area of the puncture.

It is noted that the washer <NUM> detailed above can be used to spread out the filament <NUM> so as to avoid or otherwise reduce the tendency of the plug to bunch at the apex of the puncture in a manner the same as or similar to the manner by which the more widely spaced holes <NUM> prevents or otherwise reduces the bunching tendency.

<FIG> depicts a cross-sectional view of a closure device according to the embodiment of <FIG> after delivery.

As can be seen in <FIG>, the exemplary embodiment utilizing two plugs <NUM> and <NUM>' can include two tampers <NUM> and <NUM>' to tamp locks <NUM> and <NUM>'. Use of these additional components may correspond to the teachings detailed above, albeit sequentially (tamping lock <NUM> first with tamper <NUM>, and then tamping lock <NUM>' with tamper <NUM>').

Still referring to <FIG>, an exemplary embodiment includes an alternate embodiment of a tensioner apparatus. Specifically, <FIG> depicts a tensioning apparatus <NUM>. In an exemplary embodiment, tensioning apparatus <NUM> corresponds to a spring that is biased such that the ends <NUM> and <NUM> of the spring are separated as shown in <FIG>. Specifically, ends <NUM> and <NUM> can be wrapped about filament <NUM> as conceptually shown, or otherwise may include devices at the ends that permits the filament <NUM> to slide relative therethrough while holding the filament <NUM>. Upon tensioning the filament <NUM> as detailed herein, the two portions of filament <NUM> between element <NUM> and the toggle <NUM> will tend to move towards each other. The tensioning apparatus <NUM> will resist this movement owing to the spring bias just mentioned. The more tension applied to the filament <NUM>, the greater the tendency for these portions of filament <NUM> to move towards each other, thus compressing the spring / moving the ends <NUM> and <NUM> closer together. Accordingly, a user can view the degree of closure of the spring / movement of ends <NUM> and <NUM> closer to one another, and thereby determine or otherwise estimate / gauge how much tension is being applied. In an exemplary embodiment, a gauge may be included with tensioning apparatus <NUM> that permits the user to read the tension on the filament <NUM> owing to the location of the ends <NUM> and <NUM> (or the arms that support the ends) relative to the gauge. In yet an alternate embodiment, a spacer element may be present between the ends (or arms) that functionally permits the spring to bottom out in a manner akin to that detailed above with respect to spring <NUM> /<NUM>, and thus having the functionality / utilitarian value of that configuration.

<FIG> depicts a variation of the embodiment of <FIG>, where instead of two separate tampers, a single tamper <NUM> is present that includes two lumens through which the two sides of the filament that forms loop <NUM> extends the same embodiment with a double lumen tamper used to include the double sutures.

In another embodiment, the occlusion balloon <NUM> is moved distally from the occlusive position to the puncture site, whereby the occlusive balloon <NUM> is utilized to assist with positioning the toggle <NUM> and/or the plug <NUM> and sealing the puncture. Such is depicted by way of example and not by way of limitation in <FIG>. Exemplary actions associated with such a procedure can include first position toggle intra-arterially as detailed herein and/or variations thereof in general, and, in particular, with respect to <FIG>. Once the toggle <NUM> is positioned proximate the puncture, the occlusion balloon is deflated. Next, the occlusion balloon <NUM> is moved from its occlusion position to a location corresponding to a longitudinally proximate position of the puncture. After this, the occlusion balloon <NUM> is re-inflated to occluding pressure and/or another pressure that will enable the teachings detailed herein and/or variations thereof to be practiced. This can push the toggle <NUM> against the interior of the artery as shown in <FIG>. The user can then double check the final position of the toggle <NUM> (using fluoroscopy or the like) and/or make adjustments to the tension or positioning of the plug <NUM> before deflating the balloon <NUM>. (Before deflating the balloon, the closure device <NUM> may be secured in place according to the teachings detailed herein and/or variations thereof, or such may be done after deflating the balloon. ) <FIG> depicts an action of this method, where it can be seen how the balloon <NUM> covers the toggle <NUM> and puncture site. This the action associated with <FIG> can allow for full compaction of the plug <NUM> without any risk of or otherwise significantly statistically reducing the chances of reinsertion of the plug within the artery as compared to that which would exist without use of the balloon <NUM>.

An exemplary embodiment includes the use of a double balloon catheter, where the proximal balloon serves to occlude flow, while the second, and moveable (slideable) balloon is utilized to assist with toggle and collagen placement as above. <FIG> depicts an action associated with a method of such an embodiment, where balloon <NUM>' is the occluding balloon and balloon <NUM> is the balloon that is used to position the toggle <NUM>.

<FIG> depict an alternate embodiment of a toggle. Specifically, these FIGs. depict a toggle <NUM> having hinged wings or flaps <NUM> and <NUM> via hinge features 136A and 137A. Hinge features may be barrel hinges or may be areas of relative weakness that enables the wings to hingedly move (or flap). Toggle <NUM> has a width W1 that is larger than the maximum internal diameter of the sheath <NUM> on a plane normal to the longitudinal axis thereof. In this regard, wings <NUM> and <NUM> of the toggle <NUM> (e.g., portions outboard of the dashed lines seen in <FIG>), are located outboard of the inboard portion of the toggle represented by main body <NUM>. In an exemplary embodiment, the outboard portions are flexibly connected or otherwise hingedly connected to the rest of the toggle <NUM>.

In an exemplary embodiment, the toggle <NUM> is configured to elastically deform at the areas of the hinges and/or thereabouts. By way of example, width W1 of <FIG> is a first value, corresponding to any of the values detailed above with respect to the tip to tip distance and/or variations thereof, and this value corresponds to the value when the toggle <NUM> is in the relaxed state. Upon the application of a force to the wings, the value of W1 increases, by about <NUM> (about <NUM> for each wing), although in alternate embodiments, the value W1 increases by about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or any value in between these values and/or any ranges encompassing some or all of these values (including ranges being bounded by the in between values).

This increase in value of W1 , or at least a portion thereof, elastically deforms the toggle <NUM>, such that it retains the new value of W1 or something close to that or something in between, depending on the elastic properties that come into play associated with the plastic properties.

<FIG> depicts a cross-sectional view of toggle <NUM> through section A-A of <FIG>. As can be seen, hinge features 136A and 137A are notched sections in the top surface of the toggle <NUM>. In an alternate embodiment, the notches are located in the bottom surface. In an alternative embodiment, the notches are located both above and below. In an exemplary embodiment, hinge feature 136A is a notch located on the top and hinge feature 137A is a notch located on the bottom, or visa-versa. (The holes <NUM> are not depicted in the cross-sectional view of <FIG>.

Any device, system and/or method that enables the folding functions detailed herein and/or variations thereof with respect to the wings may be utilized in some embodiments.

In an exemplary embodiment, the toggle <NUM> is such that the resistance to flexture of the toggle along lines 136A and/or 137A is substantially and/or effectively less than resistance to flexture of the toggle at locations generally proximately inboard and outboard thereof. In an exemplary embodiment, the toggle <NUM> is such that the elastic modulus of the toggle along lines 136A and/or 137A is substantially and/or effectively less than that of the toggle at locations generally proximately inboard and outboard thereof.

As noted above, the wings may expand upon the application of sufficient force thereto. In this regard, an exemplary embodiment of the toggle <NUM> is utilized in conjunction with a balloon <NUM> in a manner similar to and/or the same as that detailed above with respect to <FIG>. More particularly, <FIG> schematically illustrate a sequence according to an exemplary embodiment combining the above teachings. <FIG> depicts the toggle <NUM> positioned at the puncture, with the wings <NUM> and <NUM> drooping downward prior to applying tension to the filament beyond about that which is used to hold the toggle <NUM> against the puncture (e.g., prior to cinching the loop <NUM>, etc.) Balloon <NUM> is depicted in a deflated or semi-deflated state, and is located longitudinally proximally to the puncture (and toggle <NUM>).

<FIG> depicts inflation of the balloon <NUM>. As the balloon expands outward, wings <NUM> and <NUM> are forced outward towards the wall of the artery <NUM>. <FIG> depicts the balloon <NUM> inflated to at least about its maximum inflation dimensions. As can be seen, the wings <NUM> and <NUM> are trapped against the wall of the artery between the wall and the balloon <NUM>. At this time, additional tension is applied to the filament <NUM> to move the plug <NUM> (not shown) towards the toggle <NUM>, etc. More particularly, <FIG> depicts how balloon <NUM> (single or double embodiment) may be used to orient the wings <NUM> and <NUM> of the toggle <NUM> to assist with internal closure.

Exemplary embodiments of <FIG> and/or <FIG> can be used to substantially and/or effectively statistically reduce the chances of the toggle <NUM> dislodging and/or passing through the puncture and into the tract relative to the other embodiments detailed herein and/or variations thereof. This statistical phenomenon may be, for example, because the additional area of the toggle <NUM> owing to the wings because the wings can be folded for insertion into the sheath <NUM>. This as compared to a toggle without folding wings, where the maximum size of the toggle is limited by the internal diameter of the sheath <NUM>.

Exemplary embodiments of <FIG> and/or <FIG> can be used in applications where the puncture extends over a larger arcuate distance as compared to toggles having smaller widths. For example, the puncture may extend over an arc that extends about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM><NUM> and/or about <NUM> degrees or more and/or angles in between these in one degree increments. The embodiments of <FIG> and/or <FIG> can substantially and/or effectively statistically reduce the chances of the toggle <NUM> dislodging and/or passing through such punctures puncture and into the tract relative to the other embodiments detailed herein and/or variations thereof.

<FIG> and <FIG> depict another embodiment, where the filament is utilized to apply the above-mentioned force to the wings to expand the wings. In this regard, <FIG> is a cross-sectional view of section AA of the the toggle <NUM> depicted in <FIG>. In this embodiment, the holes <NUM> of the toggle <NUM> for the filament <NUM> are angled relative to the lateral axis <NUM> or positioned so as to aid in the support of the widened portion, or 'wings'. In an exemplary embodiment, this can aid in opening the toggle <NUM>, which has hinge sections 300A and 300B extending along the midline. In an exemplary embodiment, loop <NUM> extends through holes <NUM> as may be seen. The angle of the holes relative to axis <NUM> has utility in that as the loop <NUM> is closed due to the tensioning of filament <NUM>, the filament <NUM> applies a force onto wings 302A and 302B, lifting the wings upward and against the artery. It is noted that such utility can also be achieved without the angling of the holes <NUM> relative to axis <NUM>. In this regard, because the holes <NUM> are outboard of the hinge sections 300A and 300B, the force resulting from the tensioning of the filament <NUM> is applied to the wings, thus forcing the wings upward and against the artery.

In addition to radiopaque marking schemes mentioned above, some embodiments detailed herein and/or variations thereof may include additional markers to ensure or otherwise substantially and/or effectively statistically improve the chances of utilitarianly deploying the toggles. Radiopaque markings on the tubes can aid in enabling the user to estimate the amount of delivery tube and/or release tube that has been pushed into the vessel. This can help the user avoid unutilitarian advancement of the toggle into the vessel (e.g., too much advancement), thereby obviating any adverse situations during deployment such as catching of the toggle on the inner wall downstream. The delivery tube and/or the release tube may have radiopaque strips or rings at fixed distances. It may also have rings with increasing thicknesses. The gradient may be designed in proportion to a qualitative assessment of distance advanced. The tube(s) may also have dots in place of rings to differentiate between the radiopaque sheath tip and the delivery tube.

In a similar vein, an exemplary embodiment includes a toggle or other degradable intraluminal sealing member that includes a radiopaque marker. In an exemplary embodiment, one or more or all of the embodiments of toggles detailed herein and/or variations thereof may include therein a relatively thin stainless steel radiopaque marker (thickness of <NUM> - <NUM> (<NUM>" - <NUM>")). In some exemplary embodiments, the marker may have hollow features. <FIG> depict such an exemplary embodiment of a marker <NUM>, having hollow holes <NUM> in arms <NUM> extending from a core <NUM>. Embedded in or otherwise attached to a toggle, the hollow features can be utilized to indicate toggle orientation during deployment. By way of example, depending on the orientation of the toggle relative to a viewing perspective, the holes will appear anywhere from circular to highly elliptical. More particularly, under fluoroscopic guidance, the holes appear circular at <NUM>° relative to the viewing perspective (<FIG>), elliptical at <NUM>° relative to the viewing perspective (<FIG>), more elliptical at <NUM>° relative to the viewing perspective (<FIG>) and highly-elliptical and/or closed off completely (i.e., one cannot see through the hole as the wall of the hole blocks the view) at <NUM>° (<FIG>). Accordingly, there is a method of fluoroscopically confirming the orientation of the toggle relative to a viewing perspective based on how the holes look relative to a viewing perspective prior to initiating any of the actions detailed herein and/or variations thereof associated with deployment of the toggle.

More particularly, in an exemplary embodiment, during deployment of the toggle, the holes may appear closed (or highly elliptical) as the toggle is released from the delivery instrument and hangs in the intraluminal space. As the toggle is brought closer to the vessel wall as detailed herein, the varying degrees of circularity of the holes relative to a viewing perspective via fluoroscopy can provide the user with a visual confirmation of accurate positioning and/or utilitarian positioning of the toggle.

In an exemplary embodiment, the marker can also be used as a reinforcing element that reinforces the toggle and improves resistance to the tensioning of the filament as detailed above. This can have utilitarian value in that it can substantially and/or effectively statistically increase the likelihood that the toggle stays in contact with the inner wall of the vessel throughout the period of resorption. This as compared to that which would be the case in a similarly situated toggle without the marker. In an exemplary embodiment, the "marker" need never be used as a marker, but instead simply only as a reinforcing device.

As noted above, an exemplary embodiment includes a guide wire <NUM> that passes through holes in the plug <NUM>. <FIG> and <FIG> depict exemplary embodiments, of such a configuration. In a further embodiment, there is an extra luminal sealing component <NUM>, as depicted in <FIG>, that is in the form of a stainless steel plate or bar about <NUM> (<NUM>") long or less and about <NUM> (<NUM>") thick or less placed between the hemostatic pad <NUM> and the lock <NUM>. The plate <NUM> can have utilitarian value in that it can increase or otherwise result in utilitarian distribution of compression forces on the plug <NUM> more evenly in order to achieve statistically and/or effective reliable hemostasis.

Claim 1:
A deployment instrument (<NUM>) for sealing a percutaneous puncture (<NUM>) in a wall of a body passageway (<NUM>), the deployment instrument comprising:
a closure device (<NUM>) configured to seal the percutaneous puncture in the wall of a body passageway, the closure device (<NUM>) configured to permit a guidewire (<NUM>) to pass therethrough; and
a carrier assembly (<NUM>) configured to hold the closure device (<NUM>) in a pre-deployment state.