Instrument and methods for surgically closing percutaneous punctures

A closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device including at least one of a toggle configured to engage an interior surface of the body passageway or a plug configured to engage an exterior surface of the body passageway and a guide wire configured to extend from an outside of the body to inside the body passageway, wherein at least one of the toggle and the plug is associated with the guide wire.

BACKGROUND

Field of the Invention

The present invention relates generally to closing percutaneous punctures.

Related Art

U.S. Pat. No. 5,282,827 (hereinafter, the '827 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 '827 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 30 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.

U.S. Pat. No. 5,662,681 (hereinafter, the '681 patent), entitled Self-locking Closure for Sealing Percutaneous Punctures, also teaches systems for sealing a percutaneous incision or puncture in a blood vessel.

SUMMARY

According to one aspect there is a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device comprising at least one of an anchor configured to engage an interior surface of the body passageway or a plug configured to engage an exterior surface of the body passageway and a guide wire configured to extend from an outside of the body to inside the body passageway, wherein at least one of the anchor and the plug is associated with the guide wire.

According to another aspect, there is a deployment instrument for deploying a closure device for sealing a percutaneous puncture in a wall of a body passageway, the deployment instrument comprising the closure device a carrier device, wherein the carrier device is configured to hold the closure device in a pre-deployment state and a guide wire, the guide wire passing through at least a portion of the closure device.

According to another aspect, there is a deployment instrument for deploying a closure device for sealing a percutaneous puncture in a wall of an artery, the deployment instrument comprising the closure device, wherein the closure device includes a toggle and a plug connected to the toggle and an actuatable assembly having a portion configured to extend into the artery such that the toggle is located in the artery while, in a first state, effectively maintaining a relative position of the toggle with respect to an actuatable component of the deployment instrument.

DETAILED DESCRIPTION

Some exemplary embodiments are 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 18 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 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 inFIG. 1, where element10is a large bore sheath, element20is a guide wire, element1026is a femoral artery (depicted in cross-sectional view), element1024is the puncture in the artery (wound in the artery), element1025is the tract leading to the puncture1024and element1028is the skin. By tract it is meant the passageway in the tissue located between the artery1026and the skin1028of the being, and which is formed when the artery is punctured percutaneously.

It is noted that the scene depicted inFIG. 1may 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 inFIG. 1and/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 sheath10remains in a vessel, such as the common femoral artery, as depicted byFIG. 1and/or a variation thereof.

As can be understood by the diagram ofFIG. 1and attention to the sizing (unless otherwise noted, the drawings herein are drawn to scale), the sheath10is 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 0.4, 0.5, 0.6, 0.7 and/or 0.8 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 sheath10, 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 sheath10therethrough, after the elastic nature of the artery is taken into account).

In an exemplary embodiment, the guidwire20is utilized for advancement of a wound closure device deployment instrument through the sheath10in 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 sheath10and/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 inFIG. 1is a PTA balloon600inserted 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 inFIG. 1), and as an entry for contrast dye. Balloon600is depicted in an uninflated or semi-inflated state coupled to guidewire610. In use, inflation fluid is pumped to the balloon, to inflate the balloon600. It is noted that some embodiments may not include the balloon600/may not utilize the balloon600.

An exemplary embodiment of a closure device will now be briefly described in the context of the environment ofFIG. 1, 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 artery1026.

FIG. 2Adepicts an exemplary closure device85closing puncture1024. The closure device85includes toggle30, plug50(often referred to in the art and herein as a sealing member or collagen pad, or simply collagen), lock60, and suture (also referred to in the art and herein as filament)80, in the fully deployed state with the suture80cut below the skin level1028(the occlusion balloon is depicted in the uninflated/deflated condition.FIG. 2Bdepicts a cross-sectional view of the artery1026, which details the fit of the toggle30to the internal diameter of the artery, and also depicts the profile of the toggle30with respect to the longitudinal axis of the artery1026.

FIGS. 2A and 2Bdepict by way of example the closure unit85(comprising toggle30, collagen50, lock60, and suture80) in the fully deployed state with the suture80cut below the skin level, and the occlusion balloon deflated to re-establish blood flow in the vessel and depict the fit of the toggle30to 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 device85can 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)80can correspond to filament 34 of U.S. patent application Ser. No. 13/111,653 (hereinafter, the '653 application) filed on May 19, 2011, entitled DEPLOYMENT INSTRUMENT FOR CLOSURE DEVICE FOR PERCUTANEOUSLY SEALING PUNCTURES, the teachings of the '653 application relating to the construction and features of the filament being incorporated by reference herein for use in an embodiment herein. Lock60can correspond to lock 36 of the aforementioned '653 application (or any other lock detailed therein and variations thereof), the teachings of the '653 application relating to the construction and features of the lock being incorporated by reference herein for use in some embodiments herein. Collagen50can correspond to plug 30 of the aforementioned '653 application, although it is noted that the size of plug30may vary from that disclosed in the '653 application, the teachings of the '653 application relating to the construction and features of the plug30being incorporated by reference herein for use in an embodiment herein.

While the toggle30is different in size and geometry from that explicitly disclosed in the '653 application with respect to that anchor 32 detailed therein, in an exemplary embodiment, the toggle30corresponds to the anchor 32 of the '653 application in a modified form in accordance with the teachings detailed herein and/or variations thereof, the applicable teachings of the '653 application relating to the construction and features of the anchor 32 being incorporated by reference herein for use in an embodiment herein.

In an embodiment, the suture80is a braided multifilament size 2-0 PLLA suture. The suture80can be made from any synthetic absorbable plastic material that degrades as needed.

The plug50comprises a strip of a compressible, resorbable, collagen foam which includes one or more apertures through which portions of the suture80extend. In an embodiment, the plug50is 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 lock60comprises 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 suture80.

An embodiment of the toggle30is constructed of a 50/50 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 toggle30is a monolithic structure formed by a bio-absorbable polymer.

It is noted that the aforementioned closure device85is 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 device85(e.g., plug30and toggle30). 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 U.S. Pat. No. 5,282,827 (hereinafter, the '827 patent) and/or variations thereof, the contents of which are incorporated herein by reference in their entirety with respect to the closure device taught therein. 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 U.S. Pat. No. 5,662,681 (hereinafter, the '681 patent) and/or variations thereof, the contents of which are incorporated herein by reference in their entirety with respect to the closure device taught therein. 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., toggle30) 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 plug50) 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 10 mm, although such teachings can also be applicable to such having a diameter (inner or outer) of about 5, 6, 7, 8, 9, 10, 11, 12 and/or about 13 mm 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 90 degrees, although in some embodiments, the arc extends 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175 and/or about 180 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 8 mm, although in some embodiments, the length is about 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and/or about 15 mm 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 device85are 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 device85and/or other equivalents thereof and/or variations thereof.

FIG. 3Adepicts an exemplary deployment instrument100according to an exemplary embodiment, configured to deploy the closure device85. As described herein, deployment instrument100includes a closure device85and a guide wire20. However, in other embodiments, the deployment instrument may not include one or both of these elements.

Briefly, deployment instrument100is configured to be inserted into sheath10. Deployment instrument100includes a release tube40and a handle110. Release tube40is configured to move relative to handle110and release tube support42along longitudinal axis101via actuation of lever90clockwise or counter-clockwise relative to the handle, as depicted by arrow102. That is, movement of lever90moves release tube40(sometimes referred to herein as restraining tube40) inward/proximal to release the toggle30.

More particularly,FIG. 3Bdepicts a cross-sectional view of the distal end of the deployment instrument100, depicting additional components of the deployment instrument100. As may be seen, deployment instrument100includes a delivery tube120that is located within release tube40. The plug50of closure device85is located in the delivery tube120, with filament80extending past plug50to toggle30. It is noted that plug50may partially extend outside of tube120. In an exemplary embodiment, delivery tube120corresponds to a carrier assembly (which can include only the delivery tube or can include additional components).

As may be seen, toggle30is located such that it is at least partially located in the release tube40. In some embodiments, it may be fully located in the release tube40(i.e., no part of the toggle30extends past the distal tip of the tube40. Toggle30is held in place by filament80. As will be described in more detail below, guide wire20extends through delivery tube120and release tube40, as well as through toggle30and/or plug50. In this regard,FIG. 3Cdepicts a top view of the distal end of deployment instrument100, withFIG. 3Ddepicting a side view thereof for comparison purposes. As may be clearly seen inFIG. 3C, the guide wire20extends through toggle30(through the longitudinal center of the toggle30). In an exemplary embodiment, the association of the guide wire20with the toggle30as 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 wire20, the plug50is held within delivery tube120in a manner that is similar to and/or a manner that is the same as that associated with the plug30tubular carrier 102 of the '653 application, the teachings thereof relating to such being incorporated by reference herein for use in an embodiment herein.

FIG. 3Edepicts an end view of the deployment instrument100looking at the distal end thereof.

In operation, movement of lever90on the delivery handle110of the deployment instrument100in the direction of arrow102moves the release tube40in the proximal direction to about the location depicted inFIG. 3F(although the tube40may be moved to other locations in other embodiments, such as to a more distal location). As may be seen, the toggle30is now completely outside the release tube40, and is thus “released.”

In an exemplary embodiment, the deployment instrument100is a fully integrated system that includes the deployment device85and the guide wire20. 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 wire20may be wound in a winding with a relatively large radius to avoid kinking the guide wire.FIG. 3Gdepicts an exemplary closure device kit1000, including deployment instrument100, closure device85and guide wire20sterilized and hermetically sealed in package900. In an exemplary embodiment, kit1000may further include an insertion sheath10in package900and/or in a separate package attached thereto.

It is noted that in an alternate embodiment, the guide wire20is not part of the kit and/or the delivery instrument100. Instead, it is a separate component that is threaded through the toggle30and/or the plug50after access to the delivery instrument100(and thus the closure device85) 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 toggle30or otherwise associates the toggle30with the guide wire, followed by deployment of the closure device85.

Use of the deployment instrument100will now be detailed with respect to an exemplary deployment method of deploying the closure device85.

With the sheath10in place as seen inFIG. 1, the deployment instrument100is inserted into a proximal end (not shown) of sheath10, and moved through the sheath10until the distal end of the instrument100end extends out of the distal end of the sheath10, approximately as shown inFIG. 4. In an exemplary embodiment, the guide wire20extends through the deployment instrument100, and the deployment instrument100slides along the guide wire20(guide wire20and sheath10are generally held stationary, relative to artery1026, while deployment instrument100is moved through the sheath10). In an alternate embodiment, the guide wire20moves with the deployment instrument100, at least to a certain extent.

More particularly,FIG. 4depicts the relative locations of toggle30, the end of the delivery tube120, and the release tube40of the deployment instrument100with respect to the distal end of the sheath10. This positioning is achieved by driving the deployment instrument100through sheath10, over the guide wire20and/or with the guide wire20, until the release tube40, along with the closure device85in general and the toggle30in particular, as detailed herein and/or variations thereof (where toggle30and plug50and some of filament80is visible inFIG. 4), is positioned as shown. The positioning can be determined via the use of one or more radiopaque markers44and/or45on the release tube40. The user, utilizing fluoroscopic methods, can determine the position of radiopaque marker45, and thus the release tube40, relative to the end of the sheath10. In an exemplary embodiment, the user stops driving the deployment instrument100into the sheath10upon the marker45emerging from the sheath10(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 tube40relative to the insertion sheath10. For example, a channel which permits blood to follow through/along the instrument100to a location that is visible by the user upon the instrument100being 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 28 and/or device 28 of U.S. Pat. No. 5,282,827, the contents of which associated with such teachings are incorporated herein by reference for use in some embodiments. Any device, system and/or method that will enable the position of the instrument100to be determined or otherwise estimated may be used in some embodiments. In an alternate embodiment, the sheath10is sized and dimensioned and/or the delivery instrument100is sized and dimensioned such that movement of the deployment instrument100through the sheath10stops at a certain point (e.g., a wall of the deployment instrument10abuts the sheath10) such that the distal end of the deployment instrument10extends a distance past the distal end of the sheath10a distance having utilitarian value.

As may be seen inFIG. 4, the toggle30, which in this exemplary embodiment, is smoothly shaped, is partially covered by the release tube40upon its emergence from the sheath10. 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 toggle30catching on any plaque or other obstruction. Given the anatomical nature of the access site and puncture, the release tube40(and the delivery tube100, sheath10and guidewire20will be slightly curved as may be seen inFIG. 5. This curvature provides a biasing force on the toggle30for the release actions.

Upon positioning of the deployment instrument100at the desired position relative to the distal end of the sheath10(i.e., at the position depicted inFIG. 4), the lever90is rotated relative to the rest of the instrument100in a direction and by a sufficient amount to retract the release tube40a utilitarian distance relative to delivery tube120, thereby entirely exposing the toggle30.FIG. 5depicts such an exemplary retraction. As may be seen, guide wire20extends through toggle30after retraction of the release tube40.

Next, sheath10is withdrawn from the approximate position depicted inFIG. 5. However, prior to this, balloon600optionally can be inflated as shown inFIG. 5. Because the sheath10may exit the puncture1024when the sheath10is 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 sheath10from the artery (where blood flow flows from left to right with respect to the frame of reference ofFIG. 5).

As just noted the insertion sheath10is withdrawn from its previous position, either partially and/or fully out of the artery1026.FIG. 6depicts withdrawal of the insertion sheath10. While the sheath10is withdrawn, the relative position of the deployment instrument100relative 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 instrument100relative 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 comparingFIG. 6toFIG. 5. In this regard,FIG. 6depicts the deployment instrument100in general, and the closure device85carried thereby, in a position relative to the puncture1024having utilitarian value.

It is noted that in an exemplary embodiment, plug50can be withdrawn from tube120without contacting the sheath10and/or at least without contacting the interior of the sheath10. This may, in some embodiments, eliminate the possibility that the plug30might become stuck in the sheath10—during the deployment procedure as it expands once leaving the tube120.

In an exemplary embodiment, a contrast agent is injected distal to the balloon600. Contrast agent can indicate any leakage at the puncture site and can additionally provide for an outline of the toggle30using fluoroscopic methods.

FIG. 4Ashows the device including radiopaque marker44positioned near the puncture. Because the sheath10may exit the puncture during this step, balloon60is inflated under a low pressure to block blood flow from a proximal position. Contrast is injected distal to balloon60, which indicates any leakage at the puncture site and additionally provides for an outline of toggle30on the fluoroscope. The sheath10and/or the tube40, 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. Given the anatomical nature of the access site and puncture, release tube40and sheath10will be curved slightly, as may be seen inFIG. 5. This curvature provides a biasing force on the toggle30for the release step, discussed with respect toFIG. 6.

Still referring toFIG. 6,FIG. 6depicts how the toggle30will be released from the biased state with retraction of the release tube40. The release orients the toggle30parallel to the vessel axis. Release is confirmed by the alignment of the distal radiopaque marker44with the end of the sheath10and/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 toggle30may include material that is readily apparent through fluoroscopy. Note further that, in an exemplary embodiment, the contact of the most distal portion of the toggle30with the artery wall forces the toggle30to rotate clockwise upon sufficient movement of the release tube40, thus aligning the toggle30in a manner that will statistically improve the chances that the toggle30will 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 sheath10, such as, by way of example, at the distal end/tip of the sheath10. Such may be used, in some exemplary embodiments, to determine the position of the sheath10. 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 sheath10from 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 instrument100(e.g., the release tube40and/or the deployment tube120, such as, by way of example, based on radiopaque markers thereon, etc.), relative to the sheath10.

Next, the delivery instrument100is moved proximally such that the distal tip thereof is moved from the location depicted inFIG. 6to at least about the location depicted in the functional schematic ofFIG. 7(with sheath10not shown for clarity). This results in plug50being completely withdrawn from the artery and toggle30being drawn closer to the puncture1024and/or substantially or completely against the puncture1024. Guide wire20may move along with delivery instrument100partially and/or fully, or may remain stationary while the delivery instrument100is moved to the location ofFIG. 7and locations thereabouts. Continued movement of the delivery instrument100away from the puncture, to a location such as that depicted by way of example inFIG. 8A, pulls toggle30closer to the puncture and/or completely against the puncture, and also pulls plug50out of the delivery tube120and, as a result of a pulley action/synching action/lassoing action between the filament80, the toggle30and the plug50, the plug is pulled towards the toggle30and thus the puncture1024(in some embodiments such that it contacts the artery wall), with guide wire20having the movements or lack of movements detailed above. Below, an exemplary device that has utilitarian value in moving the plug50relative to the toggle30is described.

Next, the delivery instrument100is 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 filament80(by exposed, it is meant that the delivery tube120(or other component of the delivery instrument100) is pulled past these components such that the components emerge from the distal end of the tube120(or other component that carries these components)). It is noted that such exposure may be achieved by pulling the handle110of the delivery instrument100, which results in pulling of the delivery tube120(and the release tube40), and other components.

FIG. 8Bdepicts an exemplary result of such movement of delivery instrument10, where tamper70has been exposed from the delivery tube100(not shown inFIG. 8B, as it is exemplary moved out of the field represented byFIG. 8B). It is noted that the procedure for exposing the tamper70and the tamper70itself may correspond to the teachings of such exposure and the tamper detailed in the '827 patent, the '681 patent and/or the '653 application, the contents of which related to such exposure and the tamper being incorporated by reference herein for use in some embodiments (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. 8Arepresents by way of example how the retracting the sheath10and deployment instrument100can position the toggle30to cover the interior of the puncture.FIG. 8Brepresents how further retraction of the deployment instrument100will deploy the contents of the delivery tube100, namely the collagen50, lock60, and tamper tube70, which will allow the user to compress the collagen50in place and deploy the lock60(in embodiments that utilize such a lock). In an exemplary embodiment, these components correspond to those disclosed in the '827 patent, the '681 patent and/or the '653 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 '827 patent, the '681 patent and/or the '653. As noted above and is further detailed below, toggle30position can be confirmed fluoroscopically.

After utilitarian placement of the plug50relative to the toggle30and/or puncture1024, the plug50is locked in place by tamping lock60with tamper70in the distal direction (as represented by arrow17) as described by way of example in the '653 application. Again, an exemplary device that has utilitarian value in tamping lock60is described below.

It is noted that in an exemplary embodiment, some or all of the features associated with the methods of delivering the closure device85(including securing the closure device in place) can correspond to those variously taught in the '681 patent, the '827 patent and/or the '653 application as implemented utilizing the teachings detailed herein in general and/or the teachings applicable to the delivery instrument100and sheath10in particular, the applicable teachings of those patents and applications being incorporated by reference herein for use in some embodiments. By way of example, the teachings of the '653 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. 9Adepicts an exemplary embodiment of a toggle30A, which can be in some embodiments a large bore toggle, usable in at least some embodiments herein and methods herein. As may be seen, toggle30A includes two holes31through which filament80may extend, as described in greater detail below. (Additional features of the structural arrangement of the toggle are also described below.) Toggle30A may be utilized in an embodiment where there is no association between the toggle and the guide wire.

In an exemplary embodiment, toggle30A and/or the other toggles detailed herein and/or variations thereof are configured to utilitarianly fit to a 10 mm diameter (interior) artery. The toggle30A has a curved profile, as may be seen inFIG. 9A, which depicts both a top view and a side view of the toggle30A. In an exemplary embodiment, the top profile of the toggle30A has a generally circular profile having a radius of R1, which can be about 5 mm, in an unrestrained configuration, although in some embodiments, the profile may be a radius of about 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm and/or about 12 mm, 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 W1of about 6 mm, although in some embodiments, the width W1may be about 2 mm, 3, 4, 5, 6, 7, 8, 9 and/or about 10 mm, 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 R1and/or the width W1and/or other pertinent dimensions are such that when applied to a given artery, the wing tips37A and37B, as opposed to the longitudinal tips38A and38B, which run parallel to the longitudinal axis of the artery) contact the artery wall prior to the center39of the toggle30A. In an exemplary embodiment, the toggle30A is made of elastomeric material and/or is of a material such that, when sized and dimensioned for use, allows the toggle30A to flex (elastically and/or plastically) such that the radius R1and/or width W1decreases 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 toggle30A (tip38A to tip38B) is about 16 mm, although in some embodiments, this distance may be about 6 mm, 7, 8, 9 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26 and/or about 27 mm, 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. 9Bdepicts an alternate toggle, toggle30B, which includes a hole32, as may be seen, which accommodates the guide wire20. Particularly, guide wire20extends through hold32, and hole32permits guide wire20to slide or otherwise move therethrough. As may be seen, Hole32is located at about the lateral center of the toggle30B (lateral center being on the lateral axis301B, as may be seen) as well as or in the alternative, centered along the axis of the suture holes31, which may be slightly offset from the lateral axis301B.

In an exemplary embodiment, the location of hole32is different than that depicted inFIG. 9B. For example,FIG. 9Cdepicts hole32located in the longitudinal center of the toggle30C (longitudinal center being on the longitudinal axis301C, as may be seen), and/or, the hole32is longitudinally in between the holes31in the toggle. Any placement of hole32in 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 inFIG. 9D, where toggle30D has a notch33. 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 toggle 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 wire20, 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 filament80therethrough.FIG. 9Edepicts such an exemplary toggle30E. 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. 9Fdepicts an alternate embodiment where two holes32are utilized to respectively associate two guide wires20with the toggle30F. 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. 10Adepicts an exemplary filament80weave through holes31of an exemplary toggle30F, with element81corresponding to, for example, loop 50A and winding 52 as detailed in the '653 application, the contents of which related to the loop and winding thereof being incorporated herein by reference in an exemplary embodiment. It is noted that the exemplary embodiment ofFIG. 10Aincludes a suture hole31spacing width W2that is wider than that depicted in the exemplary toggle ofFIG. 9A. In an exemplary embodiment, the holes31are about 4 mm from one another (W2equals about 4 mm), although in some embodiments, W2is about 2 mm, 2.5, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm and/or about 10 mm 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 holes31of the toggle ofFIG. 9Acorrespond to about 1.5 mm. 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 inFIG. 10Ais applicable to the toggles detailed above and/or below. In exemplary embodiment, element81is a collar as detailed in the '653 application. Any device system and or method of achieving the utilitarian value of element81(e.g., its use as a collar), which can include permitting the loop82established by filament80to reduce in diameter (like a lasso or the like) can be used in some embodiments.

FIG. 10Bdepicts an alternate embodiment utilizing more than two toggle holes31. As may be seen, four holes31are used, through which filament80is threaded. Such an exemplary embodiment can have utility by improving pulley action for compressing the plug50(not shown inFIGS. 10A and 10B), as compared to that resulting from the configuration ofFIG. 10Aand/orFIG. 9A.

FIG. 10Cdepicts an alternate embodiment including a washer (resorbable and/or nonresorbable washer)500interposed as seen in the loop82formed with toggle30A (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, washer500, upon deployment of the closure device85, becomes located between the vessel wall and the plug50(which is interposed in the loop between the toggle30A and washer500, but not shown inFIG. 10C), or, alternatively, proximally of the plug50. In an exemplary embodiment, the distance between the holes of the washer500corresponds to the distance between the holes of the toggle30A, 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 4 mm from one another (W2equals about 4 mm), although in some embodiments, the distance is about 1 mm, about 2 mm, 2.5, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm and/or about 10 mm 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 holes31of the toggle ofFIG. 9Acorrespond to about 1.5 mm. 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 holes81or more holes. In an exemplary embodiment, the three holes are utilized with a threaded double suture.

As noted above, delivery instrument100includes a tamper70therein. While some embodiments include a tamper and are otherwise configured according to the tamper of the '827 patent, the '681 patent and/or the '653 application, an exemplary embodiment includes a tamper71that provides association between the tamper and the guide wire20, as will now be described.

An exemplary embodiment of tamper71is depicted inFIG. 11, and includes a double-lumen. Specifically, tamper71includes lumen80′, through which filament80extends, and lumen20′, through which guide wire20extends. Lumen80′ is sized and dimensioned, relative to the guide wire20and the filament80, to permit movement of the tamper71relative to the filament80, and lumen20′, in some embodiments, is sized and dimensioned to permit movement of the tamper relative to the guide wire20, while in other embodiments, it does not permit movement relative thereto.

FIG. 11Bdepicts an alternate embodiment of a tamper, tamper72, which achieves association with the guide wire via the use of guide wire carriers20″, through which guide wire20extends, the functional features of tamper72being the same as and/or similar to that of tamper71.FIG. 11Cdepicts another alternate embodiment of a tamper, tamper73, which includes guide wire slot20′″, through which guide wire20extends, and is retained therein (slidably or otherwise) via bridges21attached to the body of the tamper, the functional features of tamper73being the same as and/or similar to that of tamper71. An exemplary embodiment that achieves association with the guide wire and the tamper does not include the bridges21, 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 bridges21. 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 wire20, 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 ofFIG. 11Acan 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. 12functionally depicts the environment in which tamper71is utilized. More particularly, after the delivery instrument100is withdrawn as detailed above to expose the tamper and the other components, tamper71is exposed as depicted inFIG. 12A. In the exemplary embodiment depicted inFIG. 12, guide wire20and filament80extend through respective lumens20′ and80′. (FIG. 12Bdepicts a cross-section of tamper71taken at line A-A- ofFIG. 12B, where the guide wire12and the filament80have been removed for clarity.)

In an exemplary embodiment, the tamper71(or72or73or variations thereof) enables tamping action over/along the guide wire20and suture80, running through separate lumens20′ and80′ in the double lumen tamper, until the tamper71contacts the lock60. Upon contact, the user pushes down (continues to push down) on the lock60to compress the plug50in place/to lock the already compressed plug50in place (such as is done by way of example and not by way of limitation, as detailed in the '827 patent, the '681 patent, the '653 application, at least with respect to movement along the filament thereof), without affecting the placement of the guide wire20. The double lumen tamper71enables utilitarian support of the guide wire20, 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/or can statistically improve user experience when tamping as compared to tamping without such an association feature.

FIG. 13functionally depicts an alternate embodiment of a delivery instrument200. It is noted that some and/or all of the additional features (e.g., the tensioner apparatus, described below) described with respect to instrument200may be included in instrument100. It is further noted that an exemplary embodiment of deployment instrument200includes some or all of the features of instrument100detailed above.

Briefly, movement of the release tube40relative to the delivery tube120is achieved by applying force to section214of the release tube40in the proximal direction of the deployment instrument200, as indicated by arrow201, while applying a reaction force to the delivery tube120at section212in the direction of arrow202. Application of sufficient force thereto drives the release tube40towards the proximal end of the instrument200, and moves it relative to the deployment tube120, until section214abuts section212or until the force is reduced/eliminated. In this regard, the exemplary embodiment ofFIG. 13is such that there is a slight friction fit between the tubes40and120, 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 instrument200corresponds to that of the deployment instrument100, as well as its use.

An exemplary embodiment includes a device, system and/or method of gauging or controlling the application of tension on filament80while deploying the closure device85described herein. Specifically, the application of high tension on filament80may result in the toggle pulling out. Alternatively, insufficient tension will not compress the plug50onto the exterior vessel wall.

Prior to describing an exemplary embodiment of a tensioner assembly of the delivery instrument100, some actions associated with deployment of the closure device85by the deployment instrument100will 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 instrument100in the proximal direction causes toggle30to engage the artery wall. As the toggle30catches/engages, resistance will be felt by the user with increased movement of the deployment instrument100in the proximal direction.

With increased movement of the deployment instrument100away from the puncture, the plug50is deployed into the puncture tract with the toggle30engaging or catching the inner surface of the artery wall contiguous with the puncture. The instrument100is then pulled further outward. Inasmuch as the toggle30trapped against the interior of the artery wall, the continued retraction of the deployment instrument100causes the filament80to pull the plug50out of the delivery tube120of the deployment instrument100and 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 filament80during the retraction procedure.

Continued retraction of the instrument100brings the tamper70out of the distal end of the deployment instrument100(thus exposing the tamper70).

The retraction of the deployment instrument100carries the plug50into engagement with the exterior of the artery wall immediately adjacent the puncture. Continued retraction causes the filament80to deform the plug50, i.e., cause it to deform radially outward, in an exemplary embodiment, as detailed by way of example in the '827 patent, the '681 patent and/or the '653 application, the contents of which relating to such deployment/expansion/positioning of the plug incorporated by reference herein for use in embodiments associated with deployment of the closure device85. In an embodiment, the plug50(which may be a collagen pad, as noted above) is forced to fold down after exiting the delivery tube120(in some embodiments, it begins to fold down immediately upon exiting the delivery tube120). The existence of blood within the puncture tract can further contribute to the deformation of the plug50, 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 instrument100up the filament80until the user stops pulling. At this point the plug50should be located in the puncture tract contiguous with the opening in the artery, and the lock60(if utilized) located immediately proximally of the plug.

The plug50is now ready to be positioned in the tract. To achieve that end, the user compacts the plug50by gently tensioning the filament by, for example, pulling on the handle110of the delivery instrument100in the proximal direction with one hand. This moves loop element81down along the filament as a result of tension on filament. Here, toggle30acts in an analogous manner to a pulley as described in, for example, the '653 application, the contents of which associated with that pulley action being incorporated herein by reference for use in an exemplary embodiment utilizing such pulley action. This has the effect of tightening the loop82. As element81moves down filament section to tighten loop81, it compacts plug50. This forces plug50to conform to the artery contiguous with the puncture in the artery.

Next, the tamper71is manually slid down the filament80by the user's other hand so that it enters the puncture tract and engages the proximal side of the lock60, if present. A force is applied to tamper71sufficient to overcome the resistance to movement of the lock71relative to the filament, at least if the lock60corresponds to the lock of the '653 application. This causes the lock60to slide down filament section until it abuts element81. An exemplary embodiment of the lock60is configured, when used in conjunction with filament80, to provide a certain amount of resistance to movement along filament80. This locks element81in place, as, for example, taught in the '653 application, thus preventing loop82from expanding. This feature causes the plug50to 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 plug50is compressed between the toggle30and the lock60, plug50is 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 instrument200, but are readily applicable to deployment instrument100, as will now be described.

FIG. 13depicts a cross-sectional view of deployment instrument200, including tensioner assembly140in the form of a tensioner cartridge160. Tensioner cartridge160configured to gauge/measure and/or to control the forces (e.g., tension in filament80) resulting from deployment of closure device85. The tensioner cartridge160provides the user with visual and/or tactile and/or auditory feedback during deployment. The construction of the tensioning cartridge includes a spring150located inside a retractable tube162that allows for the passage of filament80therethrough. The cartridge160includes a retractable member170. In an exemplary embodiment, the retractable member170is fixedly attached to the filament80, such that tension on the filament80imparts a force onto the retractable member170, and thus spring150. In an alternate embodiment, the filament80is attached to one or more of the coils of spring150(e.g., the most proximal coil/last coil), such that tension on the filament80imparts a force onto the spring150. In an alternate embodiment, the retractable member170may include a soft tensioning member172through which the filament80extends. The tensioner assembly140one or more utilitarian functions. For example, it controls the force applied to the filament80(and thus the tension) by holding the filament taut during pull back of the instrument200(or100) while providing a system for allowing the user to guard against the application of too much force. By utilizing the tensioner assembly140as detailed below, a user may apply adequate filament tension for compressing the plug50and/or during tamping the lock60or 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 instrument100that results in a first tension on the filament is sufficient to withdraw the cartridge160out of the delivery tube120, exposing the cartridge160such that the user may handle the cartridge160with his or her hand. In particular, cartridge160is carried within delivery tube120such that there is a slight friction fit between the two components. This may be achieved, by way of example, via, elastomeric O-ring174, as may be seen. Application of the first tension (by applying a sufficient withdrawal force on the instrument200in the proximal direction) is sufficient to overcome the friction forces and pull the cartridge160out of the tube120. 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 tube120, and thus blocks the cartridge160until it is moved out of the tube120, or at least from in front of the cartridge160, 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 cartridge160and the delivery tube120and/or that provides the modicum of securement so as to releasably retain the cartridge160in the delivery tube120until 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 cartridge160from the delivery tube120will 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 ofFIG. 13, where the O-ring results in a friction fit between the tube120and the cartridge160, application of the first tension results in the ejectment/exposure of the cartridge160. This is schematically represented by way of example inFIG. 14. Upon sufficient exposure of the cartridge160, the user grips the cartridge160with 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 instrument200, until the cartridge160is completely free of the delivery tube120, at which point the tension in the filament80is a result of force applied to the cartridge160in the proximal direction.

An exemplary embodiment of the present invention includes a deployment instrument100including an exemplary tensioner assembly1110as may be seen conceptually inFIG. 15. In an exemplary embodiment, the tensioner assembly1110conceptually corresponds to the cartridge160detailed above, although as will be detailed below, in an exemplary embodiment of the cartridge160, there are different features between the two.

A portion of the procedure involving deployment of the closure device80in a recipient using the exemplary tensioner assembly1110ofFIG. 15will now be described. As may be seen inFIGS. 15 and 16, the tensioner assembly1110includes a frame1120in which a hub assembly1140is slidably retained. Frame1120includes protrusions1121that interact with O-ring174. In this regard, frame1120corresponds to element161ofFIG. 13. The frame1120serves as a handle that the user may grasp during application of the closure device85to 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 assembly1140includes a hub1180and a tensioner insert1200(and silicone tension block1210, which provides friction to the filament as it uncoils). The hub assembly is spring loaded by spring1220(which corresponds to spring150of the device ofFIG. 13) in the proximal direction of the deployment instrument200. That is, with respect toFIG. 15, the spring1220forces the hub assembly1140upward, relative to the frame1120. Another way of describing this is that the spring1220forces the frame1120downward, relative to the hub assembly1140.

It is noted that alternate embodiments include structure that is different from that detailed herein. Indeed, a visual comparison between the embodiment ofFIG. 13and that ofFIG. 15reveals 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 ofFIG. 15depicts a hub1140that extends into the interior of spring1220, the embodiment ofFIG. 13. Hub1140corresponds to retractable member170ofFIG. 13. However, retractable member170does not so extend into the spring150, as may be seen.

In an exemplary embodiment, the spring1220permits the tension on filament80to be controlled/ensures that sufficient tensioning and not too much tensioning is applied to the filament during deployment of the closure device85, as will now be detailed.

Referring toFIG. 15, the tensioner assembly1110includes a filament recess between the tensioner insert1200and a filament cap1240in which filament85is wound in a coil section80E, from which the filament80travels to the closure device85. The end of the filament80E is threaded through a hole1240A in the filament cap1240and is trapped between the filament cap1240and a filament lock1260to hold the end of the filament80in place. Filament lock1260may be held to filament cap1240via 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 filament80extends completely from one side of the hub1140(or the retractable member170) to the other side thereof, and further proximally out of the frame1120(or element161).

As may be seen inFIG. 15, a friction block1210is located in a cut-out section of the tensioner insert1200. In an exemplary embodiment, the friction block1210is a silicon block that is dimensioned such that when inserted in the hub1180along with tensioner insert1200, a compressive force on filament80is applied by the friction block1210and the hub1140. In some exemplary embodiments, as will be described in greater detail below, as the filament80(filament from section80E) is drawn from the spool of the tensioner assembly1110, the user feels a relatively constant resistance and/or a relatively consistent resistance as compared to other deployment instruments100(i.e., the resistance felt with one deployment instrument100used during a given procedure will be about the same as that felt during a prior procedure with another deployment instrument100). That is, the friction block1210in combination with the tensioner insert1200and hub1140function to control the force required to at least initially withdraw the filament80from the spool.

In an exemplary embodiment, friction block1210corresponds to soft tensioning member172detailed above with respect toFIG. 13. 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 instrument200sufficient to result in a first tension in the filament can result in the cartridge160(or tensioner assembly1110) being exposed (withdrawn/released from inside delivery tube120). As noted above, inasmuch as the toggle30is trapped (anchored) against the interior of the artery wall, the continued retraction of the deployment instrument200causes the filament80to pull the plug50out of the deployment tube120of the deployment instrument200. Also, once the toggle30catches on the wall of the artery, the filament80(filament from section80E or other location where the filament is stored) will be drawn from the spool of the tensioner assembly1110. Some resistance will be felt, at least in embodiments utilizing the friction block1210(or its corresponding structure172) 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 block1210/structure172is used and a bore or other space of the tension insert1200through which the filament80passes is oversized relative to the filament80). This resistance may require the user to apply about ¾ths of a pound of force to the deployment instrument200to pull the filament80out of/through hub1180/structure170. The user continues to pull the deployment instrument200away from the recipient with a force sufficient to overcome the friction resulting from the compressive force applied to the filament80by the friction block1210. At a given distance of the deployment instrument200from the recipient/from the puncture, the filament80will be completely unwound from the spool (or otherwise withdrawn through structure172until stop176strikes structure172in the case of cartridge160).FIG. 16depicts the tensioner assembly1110in the state where the filament80is about ½ way unwound from the spool andFIG. 17depicts the tensioner assembly1110in the state where all of the filament80has been unwound from the spool. The tension on filament80is high enough to unwind the filament from the spool, and potentially compresses spring1220by a corresponding amount.

At this point, with increasing force applied to the deployment instrument200, the tension in filament80reaches a high enough value (the first amount detailed above) to overcome the friction forces between the O-ring and delivery tube120, and thus the cartridge160(or tensioner assembly1110) becomes exposed exposed (withdrawn/released from inside delivery tube120).

At this point, the user grips the cartridge160or frame1120, and continues to withdraw the cartridge160or frame1120away from the recipient with a steady or increasing force. When the tensioner assembly1401110is located a first linear distance from the vessel wall, because the end of the filament80(or other part of the filament80) is trapped between filament cap1240and the filament lock1260(or element176abuts structure172), continued pulling of the tensioner assembly away from the recipient (past the first distance), when the user holds the frame1120(or element162) causes the filament80to become more tensioned because the “unwinding” of the filament80from the spool has stopped (there is no more filament from section80E to be unwound) and the end of the filament80is 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 frame1120(or element162) to move relative to hub assembly1140and thus causes spring1220(or spring150) to compress or further compress. The force compressing the spring is substantially equal to the tension in the filament80. As the tension of the filament80progressively increases as the user continues to pull the tensioner assembly200away from the recipient (via pulling on the frame1120or element162), the spring1220continues to be compressed, thus resulting in a gradual increase in the tension of the filament80as 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 assembly1140were instead rigidly fixed to the tensioner assembly1110and/or the spring1220were not present (or if structure170were instead rigidly fixed to the tensioner assembly140and/or the spring150were not present. In this regard, the spring1220/spring150provides 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 toggle30at the time that the filament80is fully unwound from the spool. Thus, there should be no sudden increase in the force/pressure on the wall at the location of the toggle30. Instead, there should be a gradual increase in the force/pressure on the wall at the location of the toggle30. In an exemplary embodiment, the hub assembly1140may travel about eight (8) millimeters upon the application of about two (2) pounds of tension force in the filament80before bottoming out (i.e., the hub assembly1140cannot move further downward/frame1120cannot move further to the upward with respect toFIG. 15). 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 1.5 pounds per 4 mm 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 (2) pounds. Thus, via a mechanical device of the deployment instrument200, a sudden increase in pressure applied to the wall of a body passageway by the toggle30is avoided.

FIG. 18depicts spring1120fully compressed upon the application of two (2) pounds of tension force in the filament80by the user while filament80is connected to toggle30(which, as noted above, is lodged in the artery). By bottoming out the hub assembly1140, and not pulling on the tensioner assembly too much more after that, the user can ensure that he or she has applied about two (2) pounds of tension force on the filament80, and not too much more. This ensures that sufficient tension has been applied to the filament to properly deploy the closure device85, and not too much more. Also, the spring1220/spring150at least partially reduces what otherwise might be a spike in the force applied to the wall of the artery upon the filament80becoming 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 spring1220/spring150is compressed (as compared to the relatively static tension resulting from friction block1210/element174), 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 spring1220is a linearly compressible spring, and thus the gradual increase in tension as the spring1220is 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 spring1220/spring150bottoms 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 filament80. Even with respect to this latter scenario, the indication afforded to the user by the spring1220/spring150provides 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 assembly100is pulled away from the recipient, and by the time that the spring1220has bottomed out, the pulley arrangement of the filament80connecting toggle30and the plug50causes the plug50to be moved into engagement with the exterior of the artery wall contiguous with the puncture. The tension in the filament80resulting from pulling the tensioner assembly away from the recipient causes the filament80to somewhat deform the plug, i.e., cause it to deform radially outward and, in some embodiments, twist. Because the spring1220/spring150permits the tension on filament80to be controlled/ensures that sufficient tensioning and not too much tensioning is applied to the filament during deployment of the closure device20, the user is provided with some reassurance that the proper amount of tensioning has been applied to the filament80to deform the plug and properly deploy the closure device20.

It is noted that in an exemplary embodiment, plug50can be withdrawn from tube120without contacting the sheath10and/or at least without contacting the interior of the sheath10. This may, in some embodiments, eliminate the possibility that the plug30might become stuck in the sheath10—during the deployment procedure as it expands once leaving the tube120.

It is noted that an exemplary embodiment includes an indicator that provides an indication to the user that the hub assembly1140has bottomed out within the frame1120(or corresponding structure). In an exemplary embodiment, the indicator corresponds to, at least conceptually and/or functionally, to the indicator taught in the '653 application, the contents of which pertaining to the indicator being incorporated herein by reference in their entirety for use in an embodiment.

Accordingly, in an exemplary embodiment, referring to the flowchart ofFIG. 19, there is a method of sealing a percutaneous puncture in a wall of a body passageway, comprising, at step1, providing a deployment instrument100including a tensioner assembly1110/140and carrying a closure device80, the closure device80including a toggle, a plug50and a contiguous elongate filament80configured to draw the plug50towards the toggle30upon the application of tension to the filament80in a direction away from the toggle30. At step2, the distal end of the deployment instrument100is positioned through the puncture into the body passageway such that the toggle30is located in the body passageway. At step3the deployment instrument100is pulled away from the puncture while the filament80is connected to the deployment instrument. This results in the application of a mechanically induced increasing tension force to the filament80that increases with increasing distance of the deployment instrument100away from the puncture, thereby drawing the toggle30and the plug50towards 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. 20Adepicts an embodiment that utilizes two plugs50and50′, each located on a portion of loop82, with a single toggle30. 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 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160 170 and/or about 180 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 10 or 20 degrees, whereas two plugs may cover a puncture extending over an arc of about 25, or or 35 or 40 or more degrees. Along these lines, the use of two holes31for the filament spread relatively far apart can space the plugs over the full area of the puncture.

It is noted that the washer500detailed above can be used to spread out the filament80so 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 holes31prevents or otherwise reduces the bunching tendency.

FIG. 20Bdepicts a cross-sectional view of a closure device according to the embodiment ofFIG. 20Aafter delivery.

As can be seen inFIG. 20A, the exemplary embodiment utilizing two plugs50and50′ can include two tampers70and70′ to tamp locks60and60′. Use of these additional components may correspond to the teachings detailed above, albeit sequentially (tamping lock60first with tamper70, and then tamping lock60′ with tamper70′).

Still referring toFIG. 20A, an exemplary embodiment includes an alternate embodiment of a tensioner apparatus. Specifically,FIG. 20Adepicts a tensioning apparatus400. In an exemplary embodiment, tensioning apparatus400corresponds to a spring that is biased such that the ends401and402of the spring are separated as shown inFIG. 20A. Specifically, ends401and402can be wrapped about filament80as conceptually shown, or otherwise may include devices at the ends that permits the filament80to slide relative therethrough while holding the filament80. Upon tensioning the filament80as detailed herein, the two portions of filament80between element81and the toggle30will tend to move towards each other. The tensioning apparatus400will resist this movement owing to the spring bias just mentioned. The more tension applied to the filament80, the greater the tendency for these portions of filament80to move towards each other, thus compressing the spring/moving the ends401and402closer together. Accordingly, a user can view the degree of closure of the spring/movement of ends401and402closer 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 apparatus400that permits the user to read the tension on the filament80owing to the location of the ends401and402(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 spring1120/150, and thus having the functionality/utilitarian value of that configuration.

FIG. 21depicts a variation of the embodiment ofFIG. 20A, where instead of two separate tampers, a single tamper75is present that includes two lumens through which the two sides of the filament that forms loop82extends the same embodiment with a double lumen tamper used to include the double sutures.

In another embodiment, the occlusion balloon600is moved distally from the occlusive position to the puncture site, whereby the occlusive balloon600is utilized to assist with positioning the toggle30and/or the plug50and sealing the puncture. Such is depicted by way of example and not by way of limitation inFIG. 22. 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 toFIG. 6. Once the toggle30is positioned proximate the puncture, the occlusion balloon is deflated. Next, the occlusion balloon600is moved from its occlusion position to a location corresponding to a longitudinally proximate position of the puncture. After this, the occlusion balloon600is 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 toggle30against the interior of the artery as shown inFIG. 22. The user can then double check the final position of the toggle30(using fluoroscopy or the like) and/or make adjustments to the tension or positioning of the plug50before deflating the balloon600. (Before deflating the balloon, the closure device20may be secured in place according to the teachings detailed herein and/or variations thereof, or such may be done after deflating the balloon.)FIG. 22depicts an action of this method, where it can be seen how the balloon600covers the toggle30and puncture site. This the action associated withFIG. 22can allow for full compaction of the plug50without 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 balloon600.

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. 23depicts an action associated with a method of such an embodiment, where balloon600′ is the occluding balloon and balloon600is the balloon that is used to position the toggle30.

FIGS. 24A, 24B and 24Cdepict an alternate embodiment of a toggle. Specifically, these FIGS. depict a toggle135having hinged wings or flaps136and137via hinge features136A and137A. Hinge features may be barrel hinges or may be areas of relative weakness that enables the wings to hingedly move (or flap). Toggle135has a width W1that is larger than the maximum internal diameter of the sheath10on a plane normal to the longitudinal axis thereof. In this regard, wings136and137of the toggle135(e.g., portions outboard of the dashed lines seen inFIGS. 24A-24C), are located outboard of the inboard portion of the toggle represented by main body138. In an exemplary embodiment, the outboard portions are flexibly connected or otherwise hingedly connected to the rest of the toggle135.

In an exemplary embodiment, the toggle135is configured to elastically deform at the areas of the hinges and/or thereabouts. By way of example, width W1ofFIG. 24Ais 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 toggle135is in the relaxed state. Upon the application of a force to the wings, the value of W1increases, by about 4 mm (about 2 mm for each wing), although in alternate embodiments, the value W1increases by about 0.5 mm, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 2.4, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.25, 6.5, 6.75 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 toggle135, such that it retains the new value of W1or something close to that or something in between, depending on the elastic properties that come into play associated with the plastic properties.

FIG. 24Ddepicts a cross-sectional view of toggle135through section A-A ofFIG. 24C. As can be seen, hinge features136A and137A are notched sections in the top surface of the toggle135. 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 feature136A is a notch located on the top and hinge feature137A is a notch located on the bottom, or visa-versa. (The holes31are not depicted in the cross-sectional view ofFIG. 24D.)

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 toggle135is such that the resistance to flexture of the toggle along lines136A and/or137A 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 toggle135is such that the elastic modulus of the toggle along lines136A and/or137A 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 toggle135is utilized in conjunction with a balloon600in a manner similar to and/or the same as that detailed above with respect toFIG. 22. More particularly,FIGS. 25A, 25B and 25Cschematically illustrate a sequence according to an exemplary embodiment combining the above teachings.FIG. 25Adepicts the toggle135positioned at the puncture, with the wings136and137drooping downward prior to applying tension to the filament beyond about that which is used to hold the toggle135against the puncture (e.g., prior to cinching the loop80, etc.) Balloon600is depicted in a deflated or semi-deflated state, and is located longitudinally proximally to the puncture (and toggle135).

FIG. 25Bdepicts inflation of the balloon600. As the balloon expands outward, wings136and137are forced outward towards the wall of the artery1026.FIG. 25Cdepicts the balloon600inflated to at least about its maximum inflation dimensions. As can be seen, the wings136and137are trapped against the wall of the artery between the wall and the balloon600. At this time, additional tension is applied to the filament80to move the plug50(not shown) towards the toggle135, etc. More particularly,FIG. 25Cdepicts how balloon600(single or double embodiment) may be used to orient the wings136and137of the toggle135to assist with internal closure.

Exemplary embodiments ofFIGS. 24A-Dand/or25A-C can be used to substantially and/or effectively statistically reduce the chances of the toggle135dislodging 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 toggle135owing to the wings because the wings can be folded for insertion into the sheath10. This as compared to a toggle without folding wings, where the maximum size of the toggle is limited by the internal diameter of the sheath10.

Exemplary embodiments ofFIGS. 24A-Dand/or25A-C 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 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160 170 and/or about 180 degrees or more and/or angles in between these in one degree increments. The embodiments ofFIGS. 24A-Cand/or25A-C can substantially and/or effectively statistically reduce the chances of the toggle135dislodging and/or passing through such punctures puncture and into the tract relative to the other embodiments detailed herein and/or variations thereof.

FIGS. 26A and 26Bdepict another embodiment, where the filament is utilized to apply the above-mentioned force to the wings to expand the wings. In this regard,FIG. 26Bis a cross-sectional view of section AA of the toggle300depicted inFIG. 26A. In this embodiment, the holes311of the toggle300for the filament80are angled relative to the lateral axis301or positioned so as to aid in the support of the widened portion, or ‘wings’. In an exemplary embodiment, this can aid in opening the toggle300, which has hinge sections300A and300B extending along the midline. In an exemplary embodiment, loop82extends through holes311as may be seen. The angle of the holes relative to axis301has utility in that as the loop82is closed due to the tensioning of filament80, the filament80applies a force onto wings302A and302B, lifting the wings upward and against the artery. It is noted that such utility can also be achieved without the angling of the holes311relative to axis301. In this regard, because the holes311are outboard of the hinge sections300A and300B, the force resulting from the tensioning of the filament80is 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 0.005″-0.010″). In some exemplary embodiments, the marker may have hollow features.FIGS. 27A-Ddepict such an exemplary embodiment of a marker2700, having hollow holes2701in arms2702extending from a core2703. 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 0° relative to the viewing perspective (FIG. 27A), elliptical at 15° relative to the viewing perspective (FIG. 27B), more elliptical at 30° relative to the viewing perspective (FIG. 27C) 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 45° (FIG. 27D). 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 wire20that passes through holes in the plug50.FIGS. 28, 29 and 30depict exemplary embodiments, of such a configuration. In a further embodiment, there is an extra luminal sealing component550, as depicted inFIG. 30, that is in the form of a stainless steel plate or bar about 0.5″ long or less and about 0.010″ thick or less placed between the hemostatic pad50and the lock60. The plate550can have utilitarian value in that it can increase or otherwise result in utilitarian distribution of compression forces on the plug50more evenly in order to achieve statistically and/or effective reliable hemostasis.

Embodiments disclosed herein and variations thereof include various interventional cardiology procedures which utilize large access sheaths to accommodate large devices. Non-exhaustive examples may include methods that include steps of balloon aortic valvuloplasty (BAV) and percutaneous aortic valve replacement (PAVR), both of which are utilized with sheaths ranging from 12-24F. Closure of access sites involving sheaths this large are accomplished with the closure devices and deployment instruments disclosed herein and variations thereof, as well as methods for closing such access sites disclosed herein (which includes those disclosed in the above referenced applications, scaled for such closure) instead of and/or in addition to surgical closure procedures and/or the use of multiple traditional vascular closure devices. In an exemplary embodiment, the devices and methods disclosed herein and variations thereof reduce by 50%, 75%, 90%, 95%, and/or 99% or more the failure rates associated with closure of access sites of the just-mentioned procedures (i) such as those disclosed by, for example, Herrmann et al, discusses the successful use of multiple 8F Angio-Seal devices (St Jude Medical, Minnetonka, Minn.) to close the arterial access site from BAV procedures, combating historical vascular complication rates from various studies ranging from 11-23%, (ii) and/or such as those disclosed by the Ramy et a12 report on the use three Perclose devices utilized for the closure of PAVR arterial access sites, suggesting deployment of the devices at 60 degree offsets to completely close the arteriotomy around the periphery.

It is noted that some embodiments include methods of utilizing the devices and/or systems and/or components detailed herein and/or variations thereof. Such methods can include individual method actions associated with/corresponding to the movement, positioning, use, etc., of the devices and systems and components detailed herein and/or variations thereof.

In an exemplary embodiment, there is a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device comprising:

at least one of an:anchor configured to engage an interior surface of the body passageway, anda plug configured to engage an exterior surface of the body passageway; and

a guide wire configured to extend from an outside of the body to inside the body passageway,

wherein the at least one of the anchor and the plug is associated with the guide wire.

In an exemplary embodiment, there is a closure device as described above and/or below, wherein the anchor is associated with the guide wire such that the anchor is slidingly coupled to the guide wire.

In an exemplary embodiment, there is a closure device as described above and/or below, wherein the anchor includes a cavity, and the guide wire extends through the cavity.

In an exemplary embodiment, there is a closure device as described above and/or below, wherein the cavity is an orifice through the anchor.

In an exemplary embodiment, there is a closure device as described above and/or below, wherein the cavity is a notch on a periphery of the anchor.

In an exemplary embodiment, there is a closure device as described above and/or below, wherein the plug is associated with the guide wire such that the plug is slidingly coupled to the guide wire.

In an exemplary embodiment, there is a deployment instrument for deploying a closure device for sealing a percutaneous puncture in a wall of a body passageway, the deployment instrument comprising:

the closure device;

a carrier device, wherein the carrier device is configured to hold the closure device in a pre-deployment state; and

a guide wire, the guide wire passing through at least a portion of the closure device.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the closure device includes a toggle, wherein the guide wire passes through the toggle.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the closure device includes a plug, wherein the guide wire passes through the plug.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, further comprising:

a tamper, wherein the guide wire is associated with the tamper.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the tamper includes a plurality of lumens, wherein the guide wire extends through one of the lumens.

In an exemplary embodiment, there is a deployment instrument for deploying a closure device for sealing a percutaneous puncture in a wall of an artery, the deployment instrument comprising:

the closure device, wherein the closure device includes a toggle and a plug connected to the toggle; and

an actuatable assembly having an actuatable portion configured to extend into the artery such that the toggle is located in the artery while, in a first state, effectively maintaining a relative position of the toggle with respect to the actuatable portion.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the actuatable assembly is configured to, upon actuation from the first state to a second state, permit the toggle to move relatively freely relative to the actuatable portion while connected to the plug and while the toggle is in the artery.
In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the actuatable assembly is configured to extend into the artery such that at least a portion of the plug is located in the artery; and

the actuatable assembly is configured to, upon actuation from the first state to a second state, permit the toggle to move relatively freely relative to the plug while connected to the plug and while the toggle and at least a portion of the plug is in the artery.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the actuatable assembly includes a first lumened component in which the plug is located and a second lumened component in which the first lumened component is located; and

wherein the instrument is configured to, upon actuation of the actuatable assembly, move the second lumened component relative to the first lumened component and/or visa-versa, thereby actuating from the first state to the second state and thereby permitting the toggle to move relatively freely relative to the actuatable portion while connected to the plug.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein at least a portion of the toggle is located within the lumen of the second lumened component; and

wherein movement of the second lumened component relative to the first lumened component and/or visa-versa, upon actuation from the first state to the second state, results in the toggle being fully exposed outside the second lumen component.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, further comprising:

a knob configured to turn relative to at least one of the first lumened component or the second lumened component to actuate the actuatable assembly.

In an exemplary embodiment, there is a deployment instrument for deploying a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device including an anchor, a plug and a contiguous elongate filament configured to draw the plug towards the anchor upon the application of tension to the filament in a direction away from the anchor, the deployment instrument comprising:

a carrier assembly, wherein the carrier assembly is configured to hold the closure device in a pre-deployment state; and

a tensioner assembly located inside the carrier assembly.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the carrier assembly includes a first lumened component, wherein the first lumened component is configured to hold the closure device in a lumen thereof; and

wherein the tensioner assembly is located in the lumen.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the tensioner assembly includes a cartridge comprising a handle, a spring, and a suture interface that moves relative to the handle, movement relative to the handle causing at least one of compression or extension of the spring; and

wherein the handle, the spring and the suture interface are located within the lumen.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the tensioner assembly is configured to increase the tension in the filament upon linear movement of the tensioner assembly away from the wall of the body passageway when the closure device is anchored to the wall via the anchor such that the tension is gradually increased as the tensioner assembly is moved between a first linear distance and a second linear distance greater than the first linear distance from the wall of the body passageway.
In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the deployment instrument is configured such that movement of the carrier assembly away from the wall of the body passageway when the closure device is anchored to the wall via the anchor with the cartridge in the carrier assembly while the filament is under tension withdraws the cartridge from the carrier assembly; and

wherein the deployment instrument is configured such that the movement withdrawing the carrier assembly results in movement of the tensioner assembly from a first location that is a linear distance from the wall of the body passageway less than the first linear distance to a second location that is greater than the linear distance from the wall to the first location and less than or about equal to the first linear distance from the wall of the body passageway.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the deployment instrument is configured such that movement of the carrier assembly away from the wall of the body passageway when the closure device is anchored to the wall via the anchor between a first linear distance from the wall to a second linear distance from the wall greater than the first linear distance while the filament is under tension results in withdrawal of the cartridge out of the first lumen; and

wherein the tensioner assembly is configured to increase the tension in the filament upon linear movement of the handle away from the wall of the body passageway when the closure device is anchored to the wall via the anchor such that the tension is gradually increased as the tensioner assembly is moved between a third linear distance and a fourth linear distance greater than the third linear distance from the wall of the body passageway, wherein the third linear distance is greater than or about equal to the second linear distance.

A closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device comprising:

a toggle configured to engage an interior surface of the body passageway; and

a filament threaded through three or more orifices in the toggle.

In an exemplary embodiment, there is a closure device as described above and/or below, wherein the filament is threaded through four orifices in the toggle.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein in the following order:

the filament enters a first orifice at a first side of the toggle and exits the first orifice at a second side opposite the first side of the toggle;

the filament enters a second orifice at a second side of the toggle and exits the second orifice at the first side of the toggle;

the filament enters a third orifice at the first side of the toggle and exits the third orifice at the second side opposite the first side of the toggle; and

the filament enters a fourth orifice at the second side of the toggle and exits the fourth orifice at the first side of the toggle.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, wherein the four orifices are generally linearly arranged across the toggle in an order of the first orifice, the second orifice, the third orifice and the fourth orifice.
In an exemplary embodiment, there is a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device comprising:

a toggle configured to engage an interior surface of the body passageway;

a looped filament extending through the toggle; and

a washer spanning across the loop and associated with the filament at two locations such that the filament of the look cannot constrict on itself proximate the washer.

In an exemplary embodiment, there is a closure device as described above and/or below, further comprising:

a first plug, wherein the filament is threaded through the first plug between the washer and the toggle on a first side of the loop; and

a second plug, wherein the filament is threaded through the second plug between the washer and the toggle on a second side of the loop opposite the first side.

In an exemplary embodiment, there is a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device comprising:

a toggle configured to engage an interior surface of the body passageway;

a looped filament extending through the toggle;

a first plug, wherein the filament is threaded through the first plug on a first side of the loop; and

a second plug, wherein the filament is threaded through the second plug on a second side of the loop opposite the first side.

In an exemplary embodiment, there is a deployment instrument for deploying a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device including an anchor, a plug and a contiguous elongate filament configured to draw the plug towards the anchor upon the application of tension to the filament in a direction away from the anchor, the deployment instrument comprising:

a closure device including an anchor and a pad connected to the anchor via a looped filament;

a first tamper lumen, the filament extending through the first tamper lumen on a first side of the loop; and

a second tamper lumen, the filament extending through the second tamper lumen on a second side of the loop.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, further comprising:

a first tamper, the first tamper including the first tamper lumen; and

a second tamper, the second tamper including the second tamper lumen.

In an exemplary embodiment, there is a deployment instrument as described above and/or below, further comprising:

a tamper, wherein the first and second tamper lumens extend through the tamper.

In an exemplary embodiment, there is a deployment instrument for deploying a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device including an anchor, a plug and a contiguous elongate filament configured to draw the plug towards the anchor upon the application of tension to the filament in a direction away from the anchor, the deployment instrument comprising:

a closure device, the closure device including a toggle and a plug connected to the toggle via a looped filament; and

a tensioner assembly, the tensioner assembly spanning the loop and being spring biased to resist closure of the loop.

In an exemplary embodiment, there is a deployment instrument as described above and/or below wherein the tensioner assembly includes a first and second arm, the arms being spring biased away from one another, the arms being respectively connected to sides of the loop, such that closure of the loop imparts a force onto the arms that drives the arms towards one another.
In an exemplary embodiment, there is a method of closing a puncture in an artery wall, comprising:

inserting an anchor through the puncture into the artery;

moving an expandable device along the longitudinal direction of the artery to a location longitudinally proximate the puncture and longitudinally proximate the anchor; and

expanding the expandable device, thereby applying a compressive force to the anchor.

In an exemplary embodiment, there is a method as described above and/or below, wherein the compressive force compresses the anchor against the artery wall.

In an exemplary embodiment, there is a method as described above and/or below, wherein the expandable device is an occlusion balloon.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

moving a second occlusion balloon along the longitudinal direction of the artery; and

occluding the artery.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

while the expandable device is applying the compressive force, moving a plug against the artery wall proximate the anchor.

In an exemplary embodiment, there is a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device comprising:

an anchor configured to engage an interior surface of the body passageway, wherein the anchor includes a first portion and a second portion, the first portion extending away from the second portion, and wherein at least one of the first portion and the second portion is hinged.

In an exemplary embodiment, there is a closure device as described above and/or below,

wherein the anchor includes a main body between the first portion and the second portion, wherein the hinge is between the first portion and the main body.

In an exemplary embodiment, there is a closure device as described above and/or below,

wherein the anchor includes a main body between the first portion and the second portion; the first portion and the second portion are hinged; the hinge of the first portion is between the first portion and the main body; and

wherein the hinge of the second portion is between the second portion and the main body.

In an exemplary embodiment, there is a closure device as described above and/or below,

wherein the hinge comprises a notch in the anchor.

In an exemplary embodiment, there is a closure device as described above and/or below,

wherein the anchor includes a plurality of orifices through which a filament is looped, one side of the loop extending through one orifice and the other side of the loop extending through the other orifice; and

wherein the hinge is between the orifices.

In an exemplary embodiment, there is a closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device comprising:

an anchor configured to engage an interior surface of the body passageway, wherein the anchor includes a fluoroscopic marker, the marker including a hole having a circular cross-sectional area extending therethrough.

In an exemplary embodiment, there is a closure device as described above and/or below,

wherein the marker includes a plurality of holes having respective circular cross-sectional areas extending therethrough.

In an exemplary embodiment, there is a closure device as described above and/or below, wherein the marker includes arms extending from one another, the respective arms having respective holes.

In an exemplary embodiment, there is a method of sealing a percutaneous puncture in a body passageway of a living being, the method comprising:

inserting an anchor into the body passageway;

inserting at least a portion of a plug coupled to the anchor into the body passageway; and

closing the puncture by moving the plug towards the anchor.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

inserting in its entirety the plug into the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the anchor is held effectively rigidly relative to the plug while inserting at least a portion of the plug into the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

at least a portion of the anchor is enclosed within a delivery apparatus while inserting at least a portion of the plug into the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the delivery apparatus is a delivery tube.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

releasing the anchor after it is held effectively rigidly relative to the plug such that the anchor is effectively movably connected to the plug while at least a portion of the plug is in the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the action of inserting the anchor into the body passageway is executed while the anchor is associated with a guidewire extending into the body passageway through the puncture from outside the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

passing the anchor completely through an insertion sheath while at least a portion of the anchor is enclosed within the delivery apparatus.

In an exemplary embodiment, there is a method of sealing a percutaneous puncture in a body passageway of a living being, the method comprising:

inserting a guidewire into the body passageway such that the guidewire extends from outside the body passageway, through the puncture and into the body passageway; and

inserting an anchor into the body passageway while the anchor is associated with the guidewire extending from outside the body passageway, through the puncture and into the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the guidewire extends through the anchor, and the anchor slides along the guidewire while inserting the anchor into the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the guidewire extends through a plug that is coupled to the anchor, and the plug slides along the guidewire while inserting the anchor into the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

associating the guidewire with the anchor prior to inserting the anchor into the body passageway.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the action of associating the guidewire is executed while the puncture is open.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the action of associating the guidewire is executed in relatively close temporal proximity to at least one of forming the puncture and closing the puncture.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

obtaining access to a deployment instrument including a closure device including the anchor and the guidewire while the anchor is associated with the guidewire.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the action of obtaining access includes opening a package containing the deployment instrument including the closure device including the anchor and the guidewire while the anchor is associated with the guidewire.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the package is at least one of a hermetically sealed.

In an exemplary embodiment, there is method of sealing a percutaneous puncture in a body passageway of a living being, the method comprising:

inserting a distal end section of a deployment instrument into the puncture from outside of the passageway, wherein the distal end section of the deployment instrument rigidly supports an anchor, the distal end section including a first component and a second component being in actuatable relationship to one another.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

actuating the deployment instrument to move the first component relative to the second component and/or visa-versa, wherein the actuation relieves the rigid support of the anchor, thereby enabling the anchor to effectively move relative to the distal end section.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

inserting the distal end section into an insertion sheath extending through the puncture from outside of the passageway to inside of the passageway while the distal end section of the deployment instrument rigidly supports the anchor.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

inserting the insertion sheath into the puncture.

In an exemplary embodiment, there is a method as described above and/or below, wherein:

the insertion sheath is inserted into the puncture such that the insertion sheath substantially deforms from a linear configuration.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

after inserting the insertion sheath into the puncture such that the insertion sheath substantially deforms from the linear configuration, moving the insertion sheath relative to the deployment instrument and/or visa-versa so that the anchor is exposed from the insertion sheath and in the passageway.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

actuating the deployment instrument to move the first component relative to the second component and/or visa-versa, wherein the actuation relieves the rigid support of the anchor, thereby enabling the anchor to effectively move relative to the distal end section.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

after actuating the deployment instrument, moving the deployment instrument in a distal direction so that the anchor abuts a wall of the passageway proximate the puncture.

In an exemplary embodiment, there is a method as described above and/or below, further comprising:

after actuating the deployment instrument, moving the deployment instrument in a distal direction so that the anchor abuts a wall of the passageway proximate the puncture and so that a plug contained in the deployment instrument moves towards the anchor and towards the puncture.

In an exemplary embodiment, there is method of sealing a percutaneous puncture in a wall of a body passageway, comprising:

providing a deployment instrument carrying a tensioner assembly and a closure device within the deployment instrument, the closure device including an anchor, a plug and a contiguous elongate filament configured to draw the plug towards the anchor upon the application of tension to the filament in a direction away from the anchor;

positioning a distal end of the deployment instrument through the puncture into the body passageway such that the anchor is positioned in the body passageway;

pulling the deployment instrument away from the puncture while the filament is connected to the tensioner assembly such that a mechanically induced tension force is applied to the filament causing the tensioner assembly to be withdrawn from an interior of the deployment instrument; and

pulling the tensioner assembly away from the puncture while the filament is connected to the tensioner assembly such that the mechanically induced tension force is applied to the filament such that the tension force increases with increasing distance of the tensioner assembly away from the puncture to draw the anchor and the seal towards each other and into engagement with the wall of the body passageway at respectively opposite sides of the wall.

In an exemplary embodiment, there is a method as described above and/or below, wherein pulling the tensioner assembly away from the puncture while the filament is connected to the tensioner assembly results in the application of a linearly increasing mechanically induced tension force to the filament.
In an exemplary embodiment, there is a method as described above and/or below, wherein the mechanically induced increasing tension force is produced via compression of a spring.
In an exemplary embodiment, there is a method as described above and/or below, wherein the tensioner assembly includes a handle that is movable relative to a first location on the tensioner assembly to which the filament is connected, the method further comprising continuing to pull the tensioner assembly away from the puncture by pulling on the handle until the handle no longer moves relative to the first location on the tensioner assembly.