Systems and methods for vascular access and closure

Abstract

Devices, systems, and methods are provided for sealing a puncture through a wail of a body lumen using a closure implant. In one example, the closure implant includes a sealant; a footplate; and a filament coupled between the sealant and the footplate, wherein the footplate comprises a frame comprising an elongate sheet including first and second ends, the frame formed from elastic material such that the frame is biased to a deployed configuration to facilitate positioning the frame against a wall of a body lumen and resiliently compressible to a delivery / configuration for loading into the passage of the bypass tube; and a cover at least partially covering the frame.

Description

SYSTEMS AND METHODS FOR VASCULAR ACCESS AND CLOSURERELATED APPLICATION DATA

[0001] The present application claims benefit of and priority to co-pending U. S. provisional applications Serial Nos. 63 / 753,946, filed February 5, 2025, and 63 / 817,956, filed June 4, 2025, the entire disclosures of which are expressly incorporated by reference herein.TECHNICAL FIELD

[0002] The present application relates generally to medical devices; and more particularly to devices and systems for providing vascular access to perform a medical procedure within a patient’s body from a percutaneous access site; devices and systems for sealing punctures in a patient’s body, e.g., a vascular puncture extending through tissue into a blood vessel after performing a procedure; and methods for using such devices and systems.BACKGROUND

[0003] Apparatus and methods are known for accessing a patient’s vasculature percutaneously to perform a procedure within the vasculature, and for sealing the puncture that results after completing the procedure. For example, a hollow needle may be inserted through a patient’s skin and overlying tissue into a blood vessel. A guide wire may be passed through the needle lumen into the blood vessel, whereupon the needle may be removed. An introducer sheath may then be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to one or more dilators.

[0004] A catheter or other device may be advanced through the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate accessing and / or introducing various devices into the vessel, while minimizing trauma to the vessel wall and / or minimizing blood loss. Upon completing the procedure, the device(s) and introducer sheath may be removed, leaving a puncture extending between the skin and the vessel wall.

[0005] To seal the puncture, external pressure may be applied to the overlying tissue, e.g., manually and / or using sandbags, until hemostasis occurs. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a medical professional's time. It is also uncomfortable for the patient and may require the patient to- - remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.

[0006] Various apparatus and methods have been suggested for sealing a percutaneous puncture instead of using external pressure. For example, U. S. Pat. No.5,222,974 issued to Kensey et al. describes a system and method for sealing a percutaneous puncture in an artery. The system includes a sealing member consisting of a resorbable plug, a rigid resorbable anchor member, and a resorbable positioning member in the form of a filament. The disclosed sealing member is designed to resorb completely within sixty to ninety (60-90) days. An advantage of the system described by Kensey et al. is that the resorbable anchor member resides within the lumen of the vessel and, combined with a suture knot on the filament, secures the resorbable plug between them and over the arteriotomy. This arrangement prevents the resorbable plug from separating from the arteriotomy post implantation. The resorbable plug is comprised of collagen, a prothrombotic material that can absorb blood leaking through the arteriotomy, initiate the clotting cascade, and promote formation of a hemostatic plug above the arteriotomy.

[0007] U. S. Pat. No. 8,617, 204 issued to Khosravi et al. describes a system and methods for sealing a percutaneous puncture in an artey'. The system comprises an elongate member with an expandable balloon located on its distal portion, a cartridge carrying an occlusion member slidably disposed about the elongate member, and a tamping tube slidably disposed about the elongate member. The elongate member is inserted into the artery, the balloon is expanded, and the balloon is retracted until it abuts the vessel wall immediately below the arteriotomy. The cartridge is advanced down the elongate member and the occlusion member is positioned against the outer surface of the vessel immediately above the arteriotomy. The cartridge is retracted, exposing the occlusion member, and the tamping tube is advanced down the elongate member to push the occlusion member against the arteriotomy and hold it in position as the balloon is deflated and the elongate member is removed. The tamping tube is then removed from the patient leaving the occlusion member in place above the arteriotomy. The occlusion member may be a permanent or degradable freeze dried hydrogel comprised of polyethylene glycol. The occlusion member (or sealant) is made of a material that is not inherently prothrombotic. Polyethylene glycol hydrogels are very biocompatible and can be designed to absorb liquid and swell; these characteristics are well suited towards use as a vascular sealant as the hydrogel can be placed above thearteriotomy in a dry state, where it subsequently absorbs blood and / or interstitial fluid to swell in place and fix itself in position above the arteriotomy,

[0008] Another commercially available vascular closure device is the Celt ACD (Vasorum Ltd., Ireland). The Celt is a non-degradable, permanent implant comprising a stainless steel member that acts as both the intravascular and extravascular components of the closure device. The implantable member is initially maintained in an elongated state for insertion into the target artery through the introducer sheath. Once resident within the vessel, the distal most portion of the implantable member is transformed into a generally disk-shaped configuration comprising multiple blades that fold out from the central member (the distal end of the implantable member retracts in the proximal dimension as the blades fan out to form the disk). The device is then withdrawn until the expanded disk is pulled into position against the inner wall of the artery at the arteriotomy. The proximal portion of the expandable member is then transformed into a generally disk-shaped configuration in a similar manner to the distal disk. This action secures the implant within the arteriotomy as the two disks are now positioned internal to and external to the vessel wall, and the disks have a diameter that substantially exceeds that of the arteriotomy itself. The implant is then disconnected from the delivery device to provide hemostasis and closure of the arteriotomy. As a result, the implantable component is secured in the arteriotomy from both the intravascular and extravascular sides of the vessel. This prevents the implant from dislocating from the arteriotomy and keeps it securely in position after the conclusion of the procedure mitigating concerns related to embolization of the implantable component.

[0009] Each of these closure devices has one or more disadvantages that prevents them from maximizing the potential of a percutaneous vessel closure device. The system of Kensey U. S. Pat. No. 5,222,974 (AngioSeal, Terumo, Japan) utilizes a material for the resorbable anchor component that is relatively low in strength. This, in turn, requires the anchor to be relatively large in order to achieve the tensile strength needed to withstand the forces associated with advancing the sealant (i.e., resorbable plug) into position above the arteriotomy. The drawback to this implementation is that the resorbable anchor intrudes or occupies a significant cross sectional area of the lumen of the vessel and can elicit an undesired alteration of blood flow or its hemodynamics. It is well known that the clotting cascade can be initiated when flowing blood stagnates or enters into a low shear state which can then lead to the formation of thrombus. In this case, the thrombus can form on or about the anchor with the potential for subsequent embolization of downstream vessels. A furtherdisadvantage of this system is that the extravascular sealant (i.e. resorbable plug) material is fabricated from collagen, a prothrombotic material. While the prothrombotic characteristic can be useful in coagulating blood that leaks through the arteriotomy or resides in the interstitial space above the arteriotomy, potential intrusion of the plug through the arteriotomy and into the lumen of the blood vessel or inadvertent deployment of sealant in the vessel potentially introduces a prothrombotic material into the bloodstream which is highly undesired. In particular, collagen that resides within the blood vessel will serve as a perpetual nidus for thrombus formation and other serious clinical sequelae.

[0010] A significant disadvantage of the system of Khosravi et al. is that it does not comprise a component or feature that secures the sealant in position relative to the arteriotomy. This type of vascular closure mechanism relies on the expansion of the hydrogel sealant to fill the potential space above the arteriotomy and apply outward pressure (or local tamponade) on the surrounding tissue to maintain its position relative to the arteriotomy. Relative motion of the tissue above the vessel with respect to the artery can loosen or fully dislodge the sealant from its original position, potentially resulting in the formation of pseudoaneurysms, hematomas or other post procedural bleeding. Once blood is allowed to circulate in the extravascular tissue, the opportunity for more tissue planes to dissect and allow expansion of the bleeding is exacerbated, all of which are highly undesirable clinically. Subsequent iterations of the design, such as those disclosed in U. S. Patent No. 11,103,224, issued to Uchida et al., attempt to mitigate this deficiency by introducing reactive polyethylene glycol components that crosslink at the time of implantation with the intention of fixing the sealant to the vessel above the arteriotomy. This technique relies on an environment that enables the crosslinking constituents to react without being diluted or overwhelmed by the amount of blood present about the arteriotomy during placement of the sealant. An excess of blood can prohibit the desired crosslinking and thereby elicit the same issue of the plug losing its relative position with respect to the arteriotomy. Even when accounting for these additional measures, the lack of an intravascular component places the sealant at risk of dislocation.

[0011] While the Celt ACD is designed to provide a secure closure by placing an intravascular and extravascular anchor on either side of the vessel wail, the design of the intravascular anchor comprises several fins or blades arranged into a disk shape that extend into the lumen of the vessel. As previously discussed, disturbances in the blood flow paths can result in the creation of low shear, stagnating flow, or recirculating flow states. Each ofthese states can promote the formation of thrombus and raises the risk of subsequent embolization of the thrombus. Additionally, the two anchors form at a set di stance apart and therefore do not account for variable vessel wall thicknesses from patient to patient. As such, the closure device may be too loose and not provide an adequate seal, or too tight and potentially cause tissue necrosis. Furthermore, a significant amount of force is required to deploy the implant from the delivery device, which potentiates malpositioning of the implant relative to the arteriotomy including inadvertent embolization of the implant which is highly undesired. When fully deployed, the surface area of the intravascular and extravascular disks that is in contact with the arteriotomy is minimal, thereby increasing the opportunity of the implant to be maldeployed or embolized.

[0012] Therefore, improved devices and methods for providing vascular access and / or sealing vascular punctures after a medical procedure would be useful.SUMMARY

[0013] The present application relates generally to medical devices. For example, devices and systems are provided for facilitating vascular access to perform a medical procedure within a patient’s body from a percutaneous access site. In addition, devices and systems are provided for sealing punctures in a patient’s body, e.g., for sealing a vascular puncture extending through tissue into a blood vessel after performing a procedure.Methods for using such devices and systems are also provided.

[0014] A phenomenon that is not addressed by any of the commercially available or historically envisioned vascular closure devices is tearing of the intimal layer of an artery inherently induced by the traditional Seidinger technique used for vessel access followed by placement of an introducer sheath. These intimal tears are typically oriented in the radial direction (i.e., perpendicular to the direction of flow) and the size of the tear correlates to the largest diameter of the needle or sheath that has been inserted into the vessel. For example, the radial tear associated with the insertion of a twenty one (21) gauge micropuncture needle is smaller than that associated with an eighteen (18) gauge needle or subsequent insertion of a four French (4F) introducer sheath into the access site initially opened by the needle. Similarly, the tear associated with a six French (6F) introducer sheath is smaller than that associated with a seven or eight French (7-8F) introducer sheath. The radial orientation of these intimal tears can dispose them to progress into an arterial dissection, which can in turn reduce blood flow to downstream organs or develop into ananeurysm. An example of these radial tears obtained from necroscopic examination of tissue from acute preclinical experiments conducted in an ovine model is provided in FIG. A. The black arrow illustrates the direction of blood flow within the vessel. The radial tear is denoted by the letter “A,” and the black bar to the right of the “A” displays the length of the radial tear. As can be seen in Figure A, the tear is generally ellipsoidal in shape with the longitudinal axis perpendicular to the direction of flow (i.e., a radial orientation). These same radial tears were observed in controlled benchtop experiments conducted on ex vivo porcine tissue, as shown in FIGS. B-l to B-4. FIG. B-l shows a representative tear in the intimal of the vessel after the insertion of a twenty one (21) gauge micropuncture needle. The white bar to the right of the tear provides a visual reference of the length of the tear (the measured length was.032”). FIG. B-2 shows a representative tear in the intimal of the vessel after the insertion of an eighteen (18) gauge needle. The white bar to the right of the tear provides a visual reference of the length of the tear (the measured length was.071”). FIG. B-3 shows a representative tear in the intimal of the vessel after the insertion of an 18 gauge needle, placement of a.035” guidewire, removal of the needle, and insertion of a 6 French introducer sheath. The white bar to the right of the tear provides a visual reference of the length of the tear (the measured length was.182”). FIG. B-4 shows a representative tear in the intimal of the vessel after the insertion of an eighteen (18) gauge needle, placement of a.035” guidewire, removal of the needle, and insertion of an eight French (8F) introducer sheath. The white bar to the right of the tear provides a visual reference of the length of the tear (the measured length was.206”). In addition to concerns about arterial dissection and other clinical impacts, the exposure of subintimal tissue signals an injury to the body and elicit the clotting cascade due to exposure of the collagen, the extracellular matrix, and other constituents to the blood flowing through the vessel. Based on these findings, devices, systems, and methods that minimize the creation of radial tears in the intima of the target vessel, or of mitigating the propagation of a tear once formed if the radial tearing cannot be eliminated, would be useful.

[0015] Another aspect of the design of existing vascular closure devices that may be improved upon is the visibility of such devices (or components of said devices) under interrogation by using various non-invasive imaging modalities such as ultrasound (US) or fluoroscopy. There would be clinical utility in providing a device that can be directly observed during deployment as many of the commercially available device designs rely on secondary feedback or surrogate information to inform the operator of the position ofdiffering components of the device within the vessel. For example, the AngioSeal device relies on monitoring bleedback (i.e., blood dripping) from a side port of a custom introducer sheath to help the operator determine how far the tip of the sheath is inserted into the target vessel, effectively acting as a surrogate depth finder pinpointing the location of the arteriotomy. While this process is relatively effective when done correctly under controlled conditions, the relative location of the introducer sheath can shift as part of the closure procedure. As the operator does not have direct visualization of the tip of the exchanged introducer sheath, they can inadvertently lose track of where the device components are during the procedure. As a further example, the AngioSeal device relies on tactile feedback of the footplate (or intravascular component) catching against the inner wall of the artery' directly below the arteriotomy to signal to the operator that the footplate is in the correct position to enable delivery of the collagen sealant outside of the vessel above the arteriotomy. The tactile (surrogate) signal that the operator looks for during this part of the closure procedure is a resistance to tension applied to the handle of the device. Under normal circumstances, a steady increase in tension with little to no corresponding retraction of the handle indicates that the footplate is properly apposed to the vessel wall at the arteriotomy. However, this tactile signal can also be elicited by the footplate getting hung up on calcific plaque or on a side branch vessel upstream of the arteriotomy. If the operator is unable to view the location of the footplate and mistakenly believes that the device is correctly positioned based on the tactile (surrogate) signal, they may continue the steps of the closure procedure per the instructions for use and inadvertently deliver the resorbable plug (i.e. collagen sealant) into the lumen of the artery inducing a potentially catastrophic clinical failure.

[0016] Designing echogenicity and / or radiopacity (or visibility under an alternative visualization modality) into some or all of the components of a vascular closure device would allow the operator to have a direct measure of the location of those components during the procedure. As an example, consider the utility of an echogenic intravascular component (either as an inherent property of the material of construction or as the result of a secondary operation that imparts echogenicity to the component) when that component is used to locate the arteriotomy. An operator can use ultrasound guidance to directly monitor / observe the location of the intravascular component within the vessel and verify that it is in the proper location and not hung up on calcific plaques or branch vessels prior to proceeding to the next step of the closure procedure, such as deploying a sealant at or abovethe arteriotomy. Similarly, the use of a sealant that has echogenic properties would allow the operator to directly observe the position of the sealant with respect to the intravascular component; this would enable the operator to ensure that the sealant is correctly or desirably positioned prior to the end of the procedure. If available, color flow Doppler could optionally then be used to interrogate the final result and rule out the formation of undesirable pseudoaneurysms, hematomas or other potential signs of blood leaking through the arteriotomy target for the closure. Similarly, materials that possess inherent or engineered radiopacity at an optimized level could be employed in much the same manner if visualization via fluoroscopy is preferred.

[0017] As an example, a device comprising a footplate or anchor component with a substantially lower profile may intrude less into the flow field in the vessel, and may (or can be designed to) minimize stagnant or recirculating areas of flow that could be sources of thrombus. The footplate may include one or more echogenic or radiopaque materials to enable ultrasonic or fluoroscopic visualization during some or all portions of the vascular closure procedure. Optionally, the footplate may include one or more features such as macroscopic or microscopic protrusions on the surface of the footplate facing the vessel wall that act to secure the intima and mitigate or prevent propagation of an existing intimal tear that may have been created, e.g., during access using the Seidinger technique. This exemplary device may optionally include one or more other features and / or components intended to secure or stabilize an intimal tear, such as sutures that may be placed during or prior to the start of the closure procedure. In one example, the device may include a plug or sealant material that is inherently echogenic or radiopaque to aid in the visibility of the operation of the device using ultrasound or fluoroscopic guidance respectively during a vascular closure procedure.

[0018] In accordance with one example, a device is provided for sealing a puncture through a wall of a body lumen that includes an outer first member comprising a first proximal end, a first distal end sized for introduction into the puncture, and a first lumen extending between the first proximal end and the first distal end; a bypass tube carried on the first distal end such that a tubular portion of bypass tube extends distally beyond the first end, the tubular portion comprising a passage communicating with the first lumen; an inner second member slidably disposed within the first lumen, the second member comprises a second proximal end, a second distal end positioned within the first lumen adjacent the first distal end; a handle on the second proximal end comprising an actuator coupled to the firstproximal end; a tamping member within the second lumen; and a closure implant comprising a biodegradable sealant within the second lumen adjacent the second distal end, a footplate disposed distal to the sealant within the passage distal to the first distal end, and a filament coupled between the sealant and the footplate and extending proximally through the second lumen to the handle. The bypass tube may be slidable proximally over the first member to deploy the footplate from the passage, the actuator movable to direct the first member proximally relative to the second member to expose the second distal end within the puncture, and the second member movable proximally relative to the tamping member to expose the sealant within a puncture and expose the tamping member to allow advancement of the tamping member to compress the sealant toward s the footplate.

[0019] In accordance with another example, a closure implant is provided for sealing a puncture through tissue communicating with a body lumen that includes a sealant; a footplate; and a filament coupled between the sealant and the footplate, wherein the footplate comprises a frame comprising an elongate sheet including first and second ends, the frame formed from elastic material such that the frame is biased to a deployed configuration to facilitate positioning the frame against a wall of a body lumen and resiliently compressible to a delivery configuration for loading into the passage of the bypass tube; and a cover at least partially covering the frame.

[0020] In accordance with still another example, a closure implant for sealing a puncture through tissue communicating with a body lumen that includes a sealant; a footplate; and a filament coupled between the sealant and the footplate, wherein one or more components of the closure implant comprise echogenic and / or radiopaque material.

[0021] In accordance with yet another example, a closure implant for sealing a puncture through tissue communicating with a body lumen that includes a sealant; a footplate; and a filament coupled between the sealant and the footplate, wherein one or more components of the closure implant comprise one or more surface treatments to enhance echogenicity of the one or more components.

[0022] In accordance with another example, a closure implant is provided for sealing a puncture through tissue communicating with a body lumen that includes a footplate; a filament coupled to the footplate; a stop attached to the filament spaced apart from the footplate; an anchor slidably disposed on the filament distal to the stop; a sealant on the filament between the anchor and the footplate such that a proximal end of the sealant abuts the anchor and a distal end of the sealant is positioned adjacent the footplate, e.g.,against an upper surface of the footplate; and a tamp lock slidably disposed over the filament proximal to the anchor such that distal advancement of the tamp lock directs the anchor distally to compress the sealant between the anchor and the footplate.

[0023] In accordance with still another example, a device is provided for sealing a puncture through a wail of a body lumen that includes an outer first member comprising a first proximal end, a first distal end sized for introduction into the puncture, and a first lumen extending between the first proximal end and the first distal end; a bypass tube earned on the first distal end such that a tubular portion of bypass tube extends distally beyond the first end, the tubular portion comprising a passage communicating with the first lumen; an inner second member slidably disposed within the first lumen, the second member comprises a second proximal end, a second distal end positioned within the passage and sized for introduction through the puncture into the body lumen, and a second lumen extending between the second proximal end and the second distal end; a closure implant comprising a footplate; a filament coupled to the footplate; a stop attached to the filament spaced apart from the footplate; an anchor slidably disposed on the filament distal to the stop; a sealant on the filament between the anchor and the footplate such that a proximal end of the sealant abuts the anchor and a distal end of the sealant is positioned adjacent the footplate; and a tamp lock slidably disposed over the filament proximal to the anchor, the sealant, and the footplate; and the tamp lock is positioned within the second lumen with a distal end of the sealant positioned immediately adjacent an outlet of the second distal end and the filament extends proximally through the second lumen, and the footplate is positioned within the passage such that an attachment location of the filament is located immediately adjacent the outlet; and a tamping member within the second lumen proximal to the tamp lock. The bypass tube may be slidable proximally over the first member, e.g., when the device is introduced into an introducer sheath, to deploy the footplate from the passage within the body lumen and the second member is movable proximally relative to the tamping member to expose the sealant within a puncture and expose the tamping member to allow advancement of the tamping member to advance the tamp lock to direct the anchor distally to compress the sealant between the anchor and the footplate.

[0024] For example, the arteriotomy through the wall of a blood vessel may be the source of bleeding between the artery and the surrounding tissue space in a percutaneous vascular closure procedure. The closure implant and devices herein may block, close, or limit the potential pathways for blood flow at the arteriotomy by placing a component of the- Il - closure implant, e.g., the distal end of the sealant, partially or fully within the arteriotomy itself such that the component fills the potential space created by the removal of the introducer sheath. In one example, the component that “corks” the arteriotomy in such a manner may be pliable and / or conformable to allow the component to fill any non-uniform spaces within the arteriotomy.

[0025] Optionally, the component may able to be introduced into the arteriotomy at a size that is equal to or smaller than the area of the arteriotomy, then expands to fill any remaining space within the arteriotomy; for example, the distal end of the sealant may have a diameter or other cross-section similar to the arteriotomy such that the distal end fills the arteriotomy. This may promote good approximation of the component against the arteriotomy-facing surfaces of the arterial wall and provide a secure seal between the component and the vessel wall. Furthermore, the placement of a closure device component within the arteriotomy may promote durable hemostasis over the longer timeline of patient recovery. A conformable material that is secured within the arteriotomy may be more resistant to shear forces that may result from patient movement during the post procedural or recovery period. For example, a material that has a degree of plastic or elastic deformation may be able to withstand or absorb transient loads without dislodging due to its ability to distribute and reduce the applied load via deformation, whereas a stiffer material may be separated from the arteriotomy as it can transmit a substantially larger fraction of the applied load to the interface between the component and the tissue.

[0026] Optionally, a conformable, swellable, corking component may be used in conjunction with the mechanical application of local tamponade over the arteriotomy, such as via advancement of a self-tightening suture knot to secure an extravascular segment of the corking member to an intravascular member or footplate to further promote hemostasis. In some cases the use of multiple closure mechanisms in a single device may be beneficial, as each individual mechanism may address a different aspect of the closure procedure. For example, local tamponade may provide acute hemostasis while the expansion of an expandable member within the arteriotomy may provide longer term hemostasis.

[0027] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0028] It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0029] FIG. A shows exemplary radial tears obtained from necroscopic examination of tissue from acute preclinical experiments conducted in an ovine model,

[0030] FIGS. B-l to B-4 show examples of tears in the intimal of a vessel after the insertion of different size needles and vascular introducer sheaths.

[0031] FIG. C shows differing degrees of radiopacity that can be imparted to a PEG sealant when differing quantities of tantalum powder are added to a solution of PEG monomers prior to the crosslinking process that forms a sealant.

[0032] FIG. 1 shows an example of a closure implant for closing a vascular puncture.

[0033] FIG. 2-1 is a perspective view of an example of a device for closing a vascular puncture, e.g. using the closure implant shown in FIG. 1.

[0034] FIG. 2- la is a detail showing components of a closure implant loaded into the device of FIG. 2-1.

[0035] FIG. 2- lb is a longitudinal cross-section of the device of FIG. 2-1.

[0036] FIG. 2-lb(A) is a detail of a distal end of the device of FIG. 2- lb showing the components of the closure implant.

[0037] FIG. 2-lb(B) is a detail of a handle on the proximal end of the device of FIG.2-lb.

[0038] FIG. 2-lc is a side view of the device of FIG. 2-1.

[0039] FIG. 2-1 c(A) is a cross-section taken at AA-AA in FIG. 2-lc.

[0040] FIG. 2-lc(B) is a cross-section taken at BB-BB in FIG. 2-lc.

[0041] FIGS. 2-2 to 2-9 show exemplary methods for closing a vascular puncture, e.g., using the device of FIG. 2-1.

[0042] FIGS, 2-4a to 2-8a are details of the closure implant during steps of the method shown in FIGS. 2-2 to 2-9.

[0043] FIG. 3-1 shows another example of a closure implant.

[0044] FIGS. 3-2 to 3-4 are cross-sectional views of the implant of FIG. 3-1 showing an exemplary method for closing a puncture in a blood vessel.

[0045] FIG. 3-5 shows yet another example of a closure implant.

[0046] FIG. 3-5a is a detail of a footplate of the implant of FIG. 3-5.

[0047] FIGS. 4-1 to 4-4 show another example of a footplate that may be included in a closure implant.

[0048] FIGS. 4-5a-4-5c shown yet another example of a footplate that may be included in a closure implant.

[0049] FIG. 4-6 shows another example of a footplate that includes anchor spikes, which may stabilize the intima contacted by the footplate after deployment.

[0050] FIG. 5 A is a side view of still another example of a closure implant.

[0051] FIGS. 5B and 5C are cross-sectional and transparent views showing the closure implant of FIG. 5 A loaded within a delivery device.

[0052] FIGS. 6A-6D show steps of an exemplary method of deploying the closure implant from the delivery device of FIGS. 5A-5C.

[0053] FIGS. 6A-1 to 6D-1 are cross-sectional details the steps shown in FIGS. 6A-6D, respectively.

[0054] FIGS. 7A and 7B show exemplary methods for placing sutures to minimize the length of intimal tear during a procedure involving percutaneous access of a blood vessel.

[0055] FIG. 8-1 is a transparent view showing still another example of a closure implant loaded within a delivery device.

[0056] FIGS. 8-2 to 8-4 show the closure implant of FIG. 8-1 in the sheathed, unsheathed, and fully deployed states, respectively.

[0057] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.DETAILED DESCRIPTION

[0058] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in theart from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0059] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0060] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0061] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[0062] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0063] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately aspecifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0064] Examples of devices and systems are described herein for sealing punctures in a patient’s body, i.e., for sealing a vascular puncture extending through tissue into a blood vessel after performing a procedure. Although separate examples are described below, it will be appreciated that components of the different examples may be combined with the other examples and / or multiples of each example may be combined.

[0065] Turning to the drawings, FIG. 1 shows an example of a closure implant that may be delivered using any of the delivery devices described herein, e.g., the closure device 200 shown in FIG. 2-1. Generally, the implant includes a sealant 208, a footplate 210, and one or more filaments 209 coupled between the sealant 208 and the footplate 210.Optionally, the implant may include one or more additional components, e.g., a gasket 211 that may at least partially surround or overlie the footplate 210, i.e., between the footplate 210 and the sealant 208; and / or a lock member 212 proximal to the sealant 208, which may be slidable distally over the filament / s) 209 to compress the sealant 208 between the lock member 212 and the footplate 210, as described further elsewhere herein.

[0066] The sealant 208 may be formed from biodegradable material, e.g., a polymer such as polyethylene glycol (“PEG”) that has been rendered biodegradable using methods well known in the art such as the inclusion of chemical groups that are susceptible to varying forms of lysis (e.g. groups that are enzymatically degradable, groups that are hydrolytically degradable, etc.). Alternatively, the sealant 208 may be formed from a non-degradable material such as PEG or other biocompatible materials known to the art. The sealant may take the form of a sheet that may be rolled or otherwise compressed to facilitate loading into a delivery device, such as the device 200 shown in FIG. 2-1. The footplate 210 may be formed from biocompatible materials, e.g,, metallic or non-metallic non-degradable materials; biodegradable materials such as PL GA, PLLA, or other polymers; and degradable metals or alloys thereof including but not limited to magnesium alloys, iron alloys, zinc alloys, and the like. All components of the closure implant, for example shown in FIG. 1, may be degradable, non-degradable, or a combination thereof. The degradation profile of all degradable components may be dialed or tuned at different timeframes, for example, intravascular components footplate 210 fully degrades first, followed by gasket 211, then sealant 208, then filament 209, then lock 212.

[0067] The sealant, footplate, and other components of the systems herein may possess echogenic or radiopaque properties, as visualizing the various components of the device during deployment may prove beneficial to the patient and operating physician. The echogenicity and / or radiopacity of the device components m ay be achieved by any number of techniques known to the art; as an example, the addition of micronized or nanoscale metallic powders to a polyethylene glycol based sealant can provide a controlled degree of echogenicity and / or radiopacity to the sealant. The irregular nature of the solids dispersed within the relatively homogenous polymeric network serves to scatter incoming ultrasound waves and render the sealant visible to ultrasound. Similarly, the incorporation of materials that are radiopaque into the body of the sealant will render the sealant radiopaque as well. The degree of radiopacity and / or echogenicity exhibited by the sealant can be tuned to a desired degree by controlling the amount of echogenic or radiopaque dopant added to the sealant. In some cases, the choice of the doping material may provide echogenicity, radiopacity, or both. The use of micronized tantalum powder would provide both echogenic and radiopaque properties to the sealant. Echogenicity is obtained via the physical characteristics of the doped sealant (i.e., the dispersion of small particles within the polymer matrix) while radiopacity is achieved via the materials characteristics (i.e. the high density, 16.7 g / cm3) of the particles themselves.

[0068] As an example, FIG. C illustrates some of the differing degrees of radiopacity that can be imparted to a PEG sealant when differing quantities of tantalum powder are added to a solution of PEG monomers prior to the crosslinking process that forms the sealant. The black arrows indicate the location of a cylindrical segment of dry PEG sealant that has been doped with differing amounts of micronized tantalum powder. The intensely black segments to the left and the right of the test segment (annotated as “B”) are stainless steel rods that have been included as positive controls. The sealant in Row 1 of FIG. C was doped with a 9.1% (by mass) quantity of tantalum when the sealant was fabricated (i.e. prior to drying). The sealant in Row 2 of FIG. C was doped with a 16.7% (by mass) quantity of tantalum when the sealant was fabricated. The sealant in Row 3 of FIG. C was doped with a 23.1% (by mass) quantity of tantalum when the sealant was fabricated. As expected, the radiopacity of the PEG segments increases along with the amount of tantalum powder in the sealant composition.

[0069] As another example, the footplate could be rendered echogenic by modifying one or more surfaces to have a repeating or irregular texture or pattern. Examples mayinclude a pattern of through-holes, dimples or depressions in a surface, linear scratches or hatching on a surface, and the like. The textured surfaces may optionally be covered by a thin film that is transparent to ultrasound. This may prove beneficial if the textured surface needs to have secure apposition to a tissue surface, or if having a smooth surface presents a less turbulent intrusion into the flow field of blood within the vessel lumen. Other techniques may be appliable as well, such as using two or more materials to provide complementary physical characteristics to the footplate. For example, an echogenic material may be embedded within a non-echogenic, but high tensile strength material to produce a footplate that has both characteristics. The fundamental radiopacity of the footplate is established by its material composition, however, that fundamental radiopacity could be augmented through incorporating additional components or materials that are in themselves radiopaque. For example, a footplate fabricated from poly lactic-co-glycolic acid (PLGA) could be doped with powdered tantalum during the fabrication process (e.g., the molding or casting of the footplate) to enhance the overall radiopacity of the component. While the examples described herein have focused on the footplate and sealant components of the device, the use of similar techniques can be extended to some or all of the device components, if desired,

[0070] Returning to FIG. 1, in the example shown, the filament(s) 209 may be coupled at a central or other intermediate location on the footplate 210, i.e., such that the footplate 210 and filament(s) 209 generally define an oblique angle with the footplate 210 being pivotable relative to the filament(s) 209. In the example shown, a first end 210a of the footplate 210 (i.e., the distal end when loaded in the closure device 200, as shown in FIG. 2-lb(A)) may be rounded and a second end 210b of the footplate 210 (i.e., the proximal end when loaded in the closure device 200) may be tapered to provide atraumatic ends and / or facilitate deployment and / or manipulation of the footplate 210. Alternatively, both first end 210a and second end 210b may have similar profile,

[0071] The footplate 210 may have a cylindrical, flat, or other desired cross- sectional shape between the first and second ends. For example, as shown in FIG. 1, the footplate 210 may have a flat upper surface (closest to the sealant) and rounded side surfaces that extend at least partially between the first and second ends 210a, 210b, which may facilitate positioning the footplate 210 during delivery, as described elsewhere herein. The footplate 210 may be substantially rigid, i.e., maintaining its shape during delivery; or may be semi-rigid or flexible, or combination of rigid and flexible, to allow the shape toadapt and conform to anatomy, e.g., the inner wall of a body lumen within which the footplate is delivered, as also described elsewhere herein. Alternatively, the footplate 210 may be formed from a substantially thin and / or flat sheet, such as the footplate shown in FIGS. 4-1 to 4-4, as described elsewhere herein.

[0072] The filament(s) 209 may be permanently attached to the footplate 210, to allow deployment and / or manipulation of the footplate during delivery of the implant. In the example shown in FIG. 1, the filament(s) 209 may be received through one or more passages or openings in the footplate 210. For example, the footplate 210 may include a passage extending between two openings (e.g., openings 210c shown in FIG. 2-lb(A)) in the upper surface such that an intermediate region 209b of a filament 209 may be received through the passage such that ends 209a of the filament 209 may extend from the footplate 210, e.g., through other components of the implant and, optionally, proximally through the delivery device, as described elsewhere herein.

[0073] The filament(s) 209 may be a flexible elongate member, e.g., a suture, mono¬ filament, thread, wire, tether, and the like, formed from biocompatible material. In one example, the filament 209 may be formed from non-degradable material; such as polyethylene (PE), polycarbonate (PC), nylon, or other plastics; or may be formed from biodegradable material, such as poly lactic-co-glycolic acid (PLGA), polylactic acid (PLA or PLLA), gut, and the like.

[0074] The filament 209 may pass through the sealant 208 one or more times along the length of the sealant 208 and then into or through the lock member 212. For example, as shown in FIG. 1, the filament 209 passes from one side of the sealant 208 to the other, back and forth multiple times between the proximal and distal ends of the sealant 208, and then at least one end 209a may extend proximally from the sealant 208.

[0075] The lock member 212 may be formed from similar materials as the footplate 210 and / or sealant 208, e.g., non-degradable or degradable materials, such as PE, PC, nylon, polyether-block-amide (PEBA), PLLA, PLGA, and the like. In one example, the lock member 212 includes a single passage therethrough and both ends 209a of the filament 209 passes through the single passage. Alternatively, the lock member 212 may include two passages such that the ends 209a pass through separate passages (not shown).

[0076] The ends 209a of the filament 209 may be secured together proximal to the locking member 212, e.g., knotted together at knot 217 and / or otherwise attached together. At least one of the ends 209a of the filament 209 may then extend from the locking member212 to the proximal end of the delivery device (not shown), to facilitate positioning and / or otherwise delivering the implant, as described further elsewhere herein,

[0077] Optionally, the closure implant may also include a gasket 211, positioned between the footplate 210 and the sealant 208. For example, the gasket 211 may be formed as a flexible sheet of material, e.g., from metal, plastic, or composite materials, which may be non-degradable or degradable, similar to the other components of the implant. In the example shown, the gasket 211 may be a generally round, oval, square, rectangle or other compound shape sheet of flexible material that may be wrapped at least partially around the footplate 210, as shown in FIG. 2-lc(B). The diameter or maximum dimension of the gasket 211 may be equal to or smaller than the length of the footplate 210 but sufficiently large to enhance sealing against a puncture through the wall of a body lumen, or may completely cover the puncture tear that is created in the vessel intima (not shown) during the procedure, e.g., as described elsewhere herein. Covering the intimal tear may prevent the direct interaction of blood to the injured vessel (i.e. vessel tear) that can initiate thrombus formation. Opti onally, the gasket 211 and / or the other components of the implants described herein may incorporate drugs such as, but not limited to, an anti¬ thrombotic drug, antiplatelet drug, anti-inflammatory drug, anti-proliferative drug, antibiotics, combinations thereof, etc.

[0078] Turning to FIG. 2-1, an exemplary closure device 200 is shown, which may be used to deliver a closure implant, such as the implant shown in FIG. 1 or any of the other examples or combinations thereof described herein. Generally, the device 200 includes an outer jacket or tubular member 206, a bypass tube 207 on the outer jacket 206 to provide a seal assembly 203 within which a closure implant may be initially carried, an inner jacket or tubular member 213 (not shown, refer to FIG. 2-la), a tamping tube or member 214 (not shown, refer to FIG. 2-la), and a handle or hub 201. The outer jacket 206, inner jacket 213, bypass tube 207, and tamping tube 214 may be formed from a variety of similar or different biocompatible materials, e.g., metal, plastic, or composite materials. For example, these components may be formed from polymeric materials, such as polyethylene (PE), polycarbonate (PC), nylon, polyether-block-amide (PEBAX), and the like.

[0079] With additional reference to FIGS. 2-la and 2-lb, the outer jacket 206 includes a proximal end 206a within the handle 201, a distal end 206b sized for introduction into a patient’s body, and a lumen 206c extending between the proximal end 206a and the distal end 206b. In one example, the distal end 206b may have an outer diameter betweenabout six French and ten French (2.0-3.3 mm) or between about five and eight French (1.6-2,7 mm). As best seen in FIG. 2-lb(A), the bypass tube 207, carried on the distal end 206b of the outer jacket 206, has an inner diameter or other cross-section larger than an outer diameter or other cross-section of the outer jacket 206 such that the bypass tube 207 is slidable proximally over the outer member 206. For example, the bypass tube 207 may include a passage 207a extending between opposite ends thereof, which may communicate with the lumen 206c of the outer jacket 206 to provide the seal assembly 203 for receiving the closure implant. For example, a portion of the distal end 206b of the outer jacket 206 may be initially received within the passage 207a such that the closure implant may be initially provided within the passage 207a and / or within the lumen 206c.

[0080] With additional reference to FIGS. 2-la and 2-lb(A), in the example shown, the bypass tube 207 includes a tubular portion 207b, e.g., sized to be received within a hub of an introducer sheath (not shown), as described elsewhere herein, including an outlet 207c communicating with the passage 207a, and an annular hub or other enlarged portion 207d, e.g., opposite the outlet 207c. The diameter or cross-section of the passage 207a may be slightly larger than the distal end 206b of the outer jacket 206 to accommodate the bypass tube 207 sliding proximally over the distal end 206b, as described further elsewhere herein.

[0081] The inner jacket 213 includes a proximal end 213a coupled to the handle 201 and a distal end 213b received within the outer jacket lumen 206c, e.g., initially spaced coaxially with the outer jacket distal end 206b, as best seen in FIGS. 2-la and 2-lb(A).?\s shown, the inner jacket 213 includes a lumen 213c extending between the inner jacket proximal and distal ends 213a, 213b, e.g., that receives the sealant 208, lock member 212, and tamping tube 214, for example, with the sealant 208 initially immediately adjacent to an outlet at the inner jacket distal end 213b.

[0082] As best seen in FIGS. 2-lb(A) and 2-lb(B), the tamping tube 214 is an elongate tubular member, slidably received within the lumen 213c of the inner jacket 213, including a proximal end 214a (not shown), a distal end 214b, and a lumen 214c extending therebetween. The tamping tube 214 may have a length substantially shorter than the inner jacket 213 such that, with the tamping tube distal end 214b initially located proximal to the lock member 212 within the inner jacket lumen 213c, e.g., as shown in FIG. 2-lb(A), the proximal end 214a is located at an intermediate location within the inner jacket lumen 213c distal to the inner jacket proximal end 213a. Thus, with the tamping tube 214 positioned distally within the inner jacket lumen 213c, the end(s) 209a of the filament 209 may passthrough the tamping tube lumen 214c, exit the tamping tube proximal end 214a and then pass proximally through the inner jacket lumen 213c into the handle 201,

[0083] Optionally, a stop may be provided on the end(s) of the filament 209 proximal to the tamping tube proximal end 214a, to prevent proximal migration of the tamping tube 214 when the inner jacket 213 is directed proximally, For example one or more knots (not shown) may be provided on the filament immediately proximal to the tamping tube proximal end 214a having a profile larger than the diameter of the tamping tube lumen 214c and smaller than the diameter of the inner jacket lumen 213c, Alternatively, a separate stop member (also not shown) may be attached, e.g., by one or more of bonding with adhesive, fusing, interference fit, and the like, to the filament 209.

[0084] With particular reference to FIG. 2-1 b(A), the device 200 may be initially provided to a surgeon or other user with the closure implant within the seal assembly 203, i.e., loaded within the passage 207a of the bypass tube 207 and / or partially within the lumen 213c of the inner jacket 213. For example, as shown, the footplate 210 may be loaded with the first end 210a immediately adjacent the outlet 207c of the bypass tube 207 and with the second end 210b immediately distal to the sealant 208, i.e., distal to the coaxial distal ends 206b, 213b of the outer and inner jackets 206, 213. The sealant 208 may be loaded into the inner jacket lumen 213c immediately adjacent to an outlet in the inner jacket distal end 213b, and the lock member 212 may be positioned immediately proximal to the sealant 208, within the inner jacket lumen 213c. The filament 209 may extend from the knot 217 through the lock member 212, sealant 208, and footplate 209 and back to couple the components together to facilitate deployment, as described elsewhere herein. At least one end 209a of the filament 209 may then extend proximally through the tamping tube lumen 214c, into the inner jacket lumen 213c, and into the handle 201, as best seen in FIGS. 2-lb(A) and 2-lb(B).

[0085] As shown in FIG. 2-lb(B), the proximal end 209a of the filament 209 may be coupled to a pulley 215 mounted within the handle 201. The proximal-most end of the filament 209 may be fixed to the pulley 215 and then the filament 209 may be wrapped one or more times around the pulley 215. The pulley 215 may be mounted on an axle 215a within handle 201 that allows the pulley 215 to rotate about the axis 215a. For example, the proximal end 209a of the filament 209 may be wrapped multiple times around the pulley 215 to take-up initial slack of the filament 209 when the device 200 is provided to the user, and the pulley 215 may be free to rotate to accommodate the filament 209 unwinding fromaround the pulley 215 during deployment of the closure implant, as described further elsewhere herein. Alternatively, the pulley may be stationary and the pulley surface may be sufficiently slippery to allow the filament 209 to slide freely around the pulley 215 to accommodate unwinding.

[0086] In addition, an actuator 205 may be provided on the handle 201, which may be coupled to the proximal end 206a of the outer jacket 206. For example, as best seen in FIG. 2-lb(B), the actuator 205 includes a slider member 205a mounted within slots or other guides 205b in the handle 201 that is attached, e.g., by one or more of interference fit, bonding with adhesive, fusing, sonic welding, cooperating connectors, and the like, to the proximal end 206a of the outer jacket 206. Initially, the slider member 205a may be provided in a distal position within the slots 205b and may include finger grips 205c that extend from the housing 201 to facilitate gripping and / or otherwise manipulating the actuator 205, i.e., to direct the slider member 205a proximally within the slots 205b to direct the outer jacket 206 proximally, as described further elsewhere herein. Optionally, the actuator 205 and / or handle 201 may include one or more cooperating locking members (not shown), that may be initially engaged to prevent the actuator 205 from moving relative to the handle 201, For example, the locking member(s) may include one or more detents or other features on the actuator 205 and / or handle that automatically disengage when a predetermined proximal force is applied to the actuator 205 to prevent accidental movement. Alternatively, a locking member may be provided that must be affirmatively disengaged before the actuator 205 may be moved.

[0087] Turning to FIGS. 2-lc, 2-lc(A), and 2-1 c(B), additional details are shown of an exemplary closure implant loaded within the closure device 200. In the example shown in FIG. 2-1 c(A), the sealant 208 may include a sheet of material folded and / or rolled to accommodate loading into the inner jacket lumen 213c with the locking member 212 proximal to the sealant 208, e.g., as shown in FIG. 2- la. The footplate 210 may be loaded with the gasket 211 wrapped around the footplate 210 such that the footplate 210 is aligned axially within the tubular portion 207b of the bypass tube 207, e.g., as shown in FIG. 2-la.

[0088] During use, the closure device 200 may be used to seal a puncture through tissue communicating with a body lumen, such as an artery or other body lumen. For example, as shown in FIG. 2-2, a puncture 90 may extend from a patient's skin 92 through intervening tissue to a body lumen 94. In one example, the puncture 90 may be apercutaneous puncture communicating with a blood vessel 94, such as a femoral artery, carotid artery, and the like.

[0089] In an exemplary method, the puncture 90 may be created using known procedures, e.g., using one or more needles, guidewires, dilators, and the like (not shown). Then, an introducer sheath 218 may be advanced through the puncture 90 into the vessel 94, i.e., over a guide wire, dilator, and the like (not shown) placed through the puncture 90 into the vessel 94, which may create intimal tears, as described elsewhere herein. Generally, the introducer sheath 218 includes a tubular member including a proximal end 218a, a distal end 218b, and a hub 218c on the proximal end 218a, which may include one or more hemostatic seals and / or other components (not shown).

[0090] The introducer sheath 218 may provide access into the vessel 94 for one or more instruments, to allow one or more diagnostic and / or interventional procedures to be performed via the vessel 94. Upon completing the procedure(s) via the vessel 94, any such instrument(s) may be removed from the puncture 90, leaving the introducer sheath 218 extending through the puncture 90 into the vessel 94, as shown in FIG. 2-2,

[0091] The closure device 200 may then be inserted into the introducer sheath 218 to deliver and deploy the closure implant. Initially, as shown in FIGS. 2-2 and 2-3, the bypass tube 207 may be inserted into the hub 218c of the introducer sheath 218 until the bypass tube hub 207d abuts the sheath hub 218c. The tubular portion 207b of the bypass tube 207 may have sufficient length to open any valves within the sheath hub 218c, to facilitate access into the lumen 218d of the sheath 218. Optionally, the bypass tube 207 and / or sheath hub 218c may include one or more connectors (not shown) for securing the bypass tube 207 to the sheath 218, to prevent relative axial and / or rotation movement.Alternatively, the bypass tube hub 207d may be sufficiently larger than the sheath hub 218c such that, when the sheath 218 is directed proximally, the sheath hub 218c may push against the bypass tube hub 207d to also direct the bypass tube hub 207 and, consequently the bypass tube 207, proximally.

[0092] As shown in FIG. 2-4, once the bypass tube 207 is received within the sheath hub 218c, the closure device 200 (other than the bypass tube 207) may be advanced distally to introduce the closure implant into the lumen 218d of the introducer sheath 218, i.e., advance the closure implant through the puncture 90 towards the vessel 94. For example, the outer jacket 206 (and inner jacket 213, etc. therein) may be advanced distally relative to the bypass tube 207 (stationary due to abutting the sheath hub 218c), thereby advancing thefootplate 210 (and gasket 211 if included) from the passage 207a of the bypass tube 207 into the sheath lumen 218d as the distal end 206b of the outer jacket 206 itself passes through the passage 207a and into the sheath lumen 218d. For example, the inner diameter of the inner jacket 213 may be smaller than the cross-section of the footplate 210 such that the inner jacket distal end 213b pushes the footplate distally through the sheath lumen 218d as the closure device 200 is advanced.

[0093] As best seen in FIG. 2-4a, as the outer jacket 206 is advanced, the footplate 210 passes through the sheath lumen 218d until released from the sheath distal end 218b into the vessel 94. If the gasket 211 is provided, the gasket 211 may resiliency unfurl or otherwise expand within the vessel 94, as shown.

[0094] Turning to FIG. 2-5, once the footplate 210 is deployed within the vessel 94, the entire closure device 200 (other than the bypass tube 207) may be directed proximally relative to the introducer sheath 218, thereby pulling the footplate 210 (and gasket 211) into contact with the distal end 218b of the sheath 218. Continued proximal movement of the closure device 200 may retract the footplate and sheath 218 until the footplate 210 (and gasket 211) contact the wall of the vessel 94 immediately adjacent the puncture. The shape of the footplate 210 may automatically adjust the orientation of the footplate 210, e.g., to align the ends 210a, 210b along the length of the vessel 94, e.g., as shown in FIG. 2-5a. If the gasket 211 is included, the gasket 211 may seat against the arteriotomy, which may enhance sealing.

[0095] Turning to FIG. 2-6, with the handle 201 under tension, the outer jacket 206 may be withdrawn relative to the introducer sheath and the other components of the closure device 200. For example, the actuator slider 205 may be directed proximally (i.e., after releasing a locking member if a locking member is present), thereby directing the outer jacket proximal end 206a proximally within the handle 201, and retracting the outer jacket distal end 206b to expose the inner jacket distal end 213b, as best seen in FIGS. 2-6a and 2-6b. Thus, at this step, the inner jacket distal end 213b remains within the introducer sheath 218 immediately adjacent the footplate 210 at the arteriotomy,

[0096] Turning to FIG. 2-7, with continued tension on the handle 201, the introducer sheath 218 may be retracted proximally and the handle 201 retracted away from the patient, thereby directing the inner jacket 213 proximally to expose the sealant 208, the lock member 212, and the tamping tube 214 from the inner jacket distal end 213b, as best seen in FIG. 2-7a. During this action, with the filament 209 coupled to the footplate 210,the end 209a of the filament 209 wrapped around the pulley 215 may unwind, thereby increasing the length of filament 209 extending between the handle 201 and the footplate 210.

[0097] When the filament 209 completely unwinds from the pulley 215, the user may feel resistance to further retraction, thereby providing a positive indication to the user that the sealant 209 and lock member 212 have been fully deployed. The length of the filament 209 may be set such that, when the filament 209 has fully unwound from the pulley 215, the inner member distal end 213b has been withdrawn proximally sufficient to fully expose the tamping tube 214, as shown in FIG. 2-7.

[0098] Turning to FIG. 2-8, with the handle 201 under continued tension, the proximal end 214a of the tamping tube 214 may be gripped and advanced to direct the distal end 214b of the tamping tube 214 distally within the puncture. Consequently, the lock member 212 may be advanced distally over the filament 209 to compress the sealant 208 within the puncture above the arteriotomy, thereby squeezing the wall of the vessel and adjacent external tissue between the sealant 208 and the footplate 210 (and gasket 211 if included), providing a seal in the arteriotomy, as best seen in FIG. 2-8a. Optionally, the filament 209 may include one or more markers (not shown) that provide indication to the user that the sealant has been sufficiently compressed, e.g., under ultrasound, fluoroscopy, or other external imaging. The marker(s) may be printed on to the filament 209, or may be a separate component attached (e.g., glued, swagged, crimped, or the like) to the filament 209.

[0099] Once the closure implant is fully seated, the tamping tube 214 may be removed, and any excess filament 209 may be cut or otherwise severed above the implant, i.e., below skin level, and the device 200 may be removed, as shown in FIG. 2-9. The procedure may then be completed using conventional methods.[000100] Optionally, the sealant, footplate, and / or other components of closure device 200 may possess echogenic or radiopaque properties. The echogenicity and / or radiopacity of the device components may be achieved by any number of techniques known to the art; as an example, the addition of micronized or nanoscale metallic powders to a polyethylene glycol based sealant may provide a controlled degree of echogenicity and / or radiopacity to the sealant. The irregular nature of the solids dispersed within the relatively homogenous polymeric network serves to scatter incoming ultrasound waves and render the sealant visible to ultrasound. Similarly, the incorporation of materials that are radiopaque into thebody of the sealant may render the sealant radiopaque as well. The degree of radiopacity and / or echogenicity exhibited by the sealant may be tuned to a desired degree by controlling the amount of echogenic or radiopaque dopant added to the sealant during its fabrication. In some cases, the choice of the doping material may provide echogenicity, radiopacity, or both. Alternatively, the surface of a given component may be modified to impart echogenicity, such as through the creation of a concentrated or disperse grouping of regular or irregular elevations and / or depressions, scratches or channels, dimples, through holes, and the like using methods well known in the art (e.g,, sandblasting, machining, etching, etc.).[000101] Additionally, the individual components of closure device 200 may be optionally modified to enhance the endothelization and eventual integration of the components into the vessel wall. Such modifications may include bonding cell signaling moieties (e.g., vascular endothelial growth factor(s) and the like) to the individual components of closure device 200 or incorporating such moieties into the internal structure of the components themselves. For example, the sealant component of the closure device may include cell signaling ligands (e.g., growth factors, cytokines, chemokines, etc.) to improve the integration of the sealing component into the surrounding tissue and accelerate wound healing.[000102] Turning to FIG. 3-1, another example of a closure implant 300 is shown that generally includes a footplate 301 and sealant 303, which may be coupled together by one or more filaments 302, similar to other devices herein. In this example, the footplate 301 may be a disc or sheet, having a circular or oval shape, which may be biased to a convex shape or may be flexible to conform to vessel wall that is similar to the curvature of the inner surface of a blood vessel or other body lumen. The footplate 302 may be formed from similar materials to other footplates herein, but may be relative thin and substantially uniform, to facilitate placing the footplate 301 against the wall of a vessel at an arteriotomy.[000103] The sealant 303 may be formed as a plug having a cylindrical or otherwise shaped elongate body made from a degradable or non-degradable polymer, such as PEG. In the example shown, a single filament 302 extends from the footplate 301 and passes through the sealant 303 along its length, e.g., between proximal and distal ends 303a, 303b of the sealant 303, such that the sealant 303 may be slidable along the filament 302 towards the footplate 301 during deployment, as described further elsewhere herein.- 21 - [000104] Optionally, the sealant 303 may include an annular groove or other undercut 306, e.g., extending around the circumference of the sealant 303 adjacent the distal end 303b, which may enhance engagement with a wall of the vessel being sealed. In addition or alternatively, the sealant 303 may include a slit or other feature 307 formed in the proximal end 303a, if desired.[000105] In addition, the implant 300 may also include a flange member 304 that may also be coupled to filament 302, such that the sealant 303 is positioned between the flange 304 and the footplate 301. The filament 302 may pass through a central portion of the flange 304, such that the flange 304 is slidable along the filament 302 towards the sealant 303, as described further below. The flange 304 may have a substantially flat disc extending radially from the central portion, i.e., having a circular or other outer shape, and having a uniform or variable thickness.[000106] Optionally, the flange 304 may include a tapered cone or other extension 308 extending distally from the central portion towards the sealant 303. The extension 308 may be sized to be received within the slit(s) 307 in the proximal end 303a of the sealant 303, which may facilitate expansion and / or otherwise enhance sealing with the sealant 303. For example, the flange 304, particularly, the extension 308, may have greater rigidity than the sealant material to facilitate expansion of the sealant 303 during deliver, as described further below[000107] Optionally, a flange lock 309 may be provided on the filament 302, e.g., initially between the sealant 303 and the flange 304, as shown in FIG. 3-2. The flange lock 309 may be attached to the filament 302 such that the flange lock 309 cannot move axially relative to the filament 302. The flange lock 309 may be formed from degradable or non-degradable materials, e.g., metal, plastic or composite materials, similar to other implant components described elsewhere herein, which may be permanently attached to the filament, for example, by one or more of interference fit, bonding with adhesive, fusing, sonic welding, and the like. In one example, the flange lock 309 may have a tapered proximal end and a blunt distal end, which may facilitate the flange 304 passing distally over the flange lock 309 while resisting the flange 304 thereafter passing proximally back over the flange lock 309.[000108] In another example, shown in FIG. 3-5, the filament 302 may be formed with an integral flange lock 309, i.e., attached to or formed in the filament 302. In this example, the footplate 312 includes a wire frame or thin sheet scaffold (not shown), e.g., formed fromnon-degradable material such as stainless steel, Nitinol, or other metal, or degradable material, such as those described elsewhere herein. The frame may have any desired shape, e.g., a round, rectangular, oblong, oval, or other shape. A cover 312a may be provided over the frame, e.g., a liner or sheet attached to the frame over the outer and / or inner surfaces of the frame, which may be formed from thermoplastic or thermoset polymers, such as silicone, ePTFE, polyurethane (PU), and the like, or other flexible materials. For example, the frame may be sufficiently flexible to allow the footplate to be rolled, folded, and / or otherwise compressed for loading in a delivery device, yet resiliently expandable to return to its open or expanded shape when deployed.[000109] Turning to FIGS. 3-2 to 3-4, an exemplary method is shown for sealing a puncture through tissue communicating with a blood vessel or other body lumen 94, e.g., similar to other closure implants and delivery devices described elsewhere herein. The implant 300 may be initially provided within a delivery device, e.g., similar to the closure device 200 shown in FIGS. 2-1 to 2-lc. For example, the footplate 301 may be rolled, folded, and / or otherwise compressed such that the footplate 301 may be provided within the bypass tube 207 and the sealant 303 and flange 304 (if included) may be provided within the inner jacket 213. Alternatively, the implant 300 may be delivered using other delivery devices that allow the footplate 301 to be initially deployed and manipulated before deploying the sealant 303 and flange 304.[000110] For example, as shown in FIG. 3-2, the footplate 301 has been introduced and deployed within the vessel 94 and then positioned against the vessel wall adjacent the arteriotomy 311. The sealant 303 may then be deployed and advanced against the footplate 301, e.g., through the arteriotomy 311. For example, a tamping tube 305 may be provided (i.e., introduced, exposed, and advanced using methods similar to the closure device 200), which may be advanced over the filament 302 to direct the sealant 303 through the arteriotomy against the footplate 301. For example, initially, the tamping tube 305 may be advanced to push the flange 304 and sealant 303 distally until the distal end 303 passes through the arteriotomy 311. Optionally, if the sealant 303 includes the annular groove 306, the wall of the vessel surrounding the arteriotomy 311 may be at least partially received within the groove 306.[000111] Turning to FIG. 3-3, the tamping tube 305 may be advanced further to push the flange 304 against and / or into the sealant 303. For example, as shown, the tamping tube 305 may push the flange 304 to direct the cone or extension 308 into the proximal end 303aof the sealant 303. If the sealant 303 includes the slit 307, the extension 308 may force the slit 307 to open, thereby expanding the proximal end 303a of the sealant 303, as shown in FIG. 3-4.[000112] Continued advancement of the tamping tube 305 may cause the sealant 303 to expand radially to engage the wall of the vessel 94 and other external tissue surrounding the arteriotomy 311, which may create a robust seal.[000113] In addition, if the flange lock 309 is provided on the filament 302, the tamping tube 305 may push the flange 304 distally to pass over the flange lock 309, as shown in FIG. 3-3. The blunt distal end of the flange lock 309 may subsequently prevent the flange 304 from migrating proximally away from the footplate 301, thereby securing the sealant 303 between the flange 304 and the footplate 301, as shown in FIG. 3-4. Once the sealant 303 is compressed, the tamping tube 305 may be removed and excess filament 302 severed, similar to other devices and methods described herein.[000114] Optionally, the sealant, footplate, and / or other components of closure device 300 may possess echogenic or radiopaque properties. The echogenicity and / or radiopacity of the device components may be achieved by any number of techniques known to the art; as an example, the addition of micronized or nanoscale metallic powders to a polyethylene glycol based sealant can provide a controlled degree of echogenicity and / or radiopacity to the sealant. The irregular nature of the solids dispersed within the relatively homogenous polymeric network selves to scatter incoming ultrasound waves and render the sealant visible to ultrasound. Similarly, the incorporation of materials that are radiopaque into the body of the sealant may render the sealant radiopaque as well. The degree of radiopacity and / or echogenicity exhibited by the sealant may be tuned to a desired degree by controlling the amount of echogenic or radiopaque dopant added to the sealant. In some cases, the choice of the doping material may provide echogenicity, radiopacity, or both. Alternatively, the surface of a given component may be modified to impart echogenicity, such as through the creation of a concentrated or disperse grouping of regular or irregular elevations and / or depressions, scratches or channels, dimples, through holes, and the like using methods well known in the art (e.g., sandblasting, machining, etching, etc.).[000115] Additionally, the individual components of closure device 300 may be optionally modified to enhance the endothelization and eventual integration of the components into the vessel wall. Such modifications may include bonding cell signaling moieties (e.g., vascular endothelial growth factor(s) and the like) to the individualcomponents of closure device 300 or incorporating such moieties into the internal structure of the components themselves. For example, the sealant component of the closure device may include cell signaling ligands (e.g., growth factors, cytokines, chemokines, etc.) to improve the integration of the sealing component into the surrounding tissue and accelerate wound healing.[000116] Turning to FIGS. 4-1 to 4-4, another example of a footplate 400 is shown that may be included in a closure implant, e.g., in place of any of the footplates described elsewhere herein. For example, the footplate 400 may replace the footplate 210 (and gasket 211) in the implant shown in FIG. 1, e.g., to provide a closure implant including the sealant 208, lock member 212, and footplate 400 coupled together by one or more filaments 209 including knot 217, e.g., as shown in its delivered state in FIG. 4-4.[000117] Generally, the footplate 400 includes a frame 401, which may be formed from non-degradable or degradable material, similar to other components herein. For example, the frame 401 may be formed from elastic or superelastic material, which may be heat treated or otherwise processed such that the frame 401 is biased to a predetermined shape, e.g., the shape shown in FIGS. 4-2 and 4-3, yet may be resiliently rolled, folded, and / or otherwise compressed for loading in a delivery device, such as the bypass tube 207 of closure device 200 shown in FIG. 2-1.[000118] For example, the frame 401 may be formed from a metallic or nonmetallic sheet and / or tubing, e.g., Nitinol, magnesium, zinc, and / or iron, or a plastic sheet of non- degradable or degradable material, similar to other implant components described herein, which may have a thickness between about 0.001-0.010 inch (0.025-0.25 mm), or between about 0.002-0.005 inch (0.05-0.125 mm). The sheet may be processed to provide the desired elements shown, e.g., by one or more of laser cutting, stamping, casting, molding and the like. In one particular example, the frame 401 may be formed from Nitinol (or other material), which may be heat treated to provide a temperature-activated shape memory in the frame 401, which may be soft and flexible below body temperature, e.g., in a martensitic state, and may transform to an austenitic state, e.g., having an Af temperature range of between thirty three and thirty seven degrees Celsius (33-37°C).[000119] For example, the Ar temperature may be set such that the frame 401 fully recovers its programmed shape when exposed to body temperature, e.g., when deployed within a blood vessel or other body lumen. At or below room temperature, the frame maybe in a fully martensitic state, which may facilitate compressing and loading the frame 401 into the bypass tube or other delivery device without permanent plastic deformation.[000120] Optionally, frame 401 and / or liner 402 may possess echogenic or radiopaque properties. The echogenicity and / or radiopacity of the device components may be achieved by any number of techniques known to the art; as an example, the addition of micronized or nanoscale metallic powders to a polyethylene glycol based sealant can provide a controlled degree of echogenicity and / or radiopacity to the sealant. The irregular nature of the solids dispersed within the relatively homogenous polymeric network serves to scatter incoming ultrasound waves and render the sealant visible to ultrasound. Similarly, the incorporation of materials that are radiopaque into the body of the sealant may render the sealant radiopaque as well. The degree of radiopacity and / or echogenicity exhibited by the sealant may be tuned to a desired degree by controlling the amount of echogenic or radiopaque dopant added to the sealant. In some cases, the choice of the doping material may provide echogenicity, radiopacity, or both. Alternatively, the surface of a given component may be modified to impart echogenicity, such as through the creation of a concentrated or disperse grouping of regular or irregular elevations and / or depressions, scratches or channels, dimples, through holes, and the like using methods well known in the art (e.g,, sandblasting, machining, etching, etc.).[000121] Optionally, the frame 401 may be at least partially covered with a liner, sheet, or other material 402, e.g., covering the surfaces and / or openings of the frame 401, as represented by the hatching in FIG. 4-1. The liner 402 may provide coverage of an intimal tear and thereby prevent the direct interaction of blood to the injured vessel (i.e., vessel tear) that may initiate thrombus formation. The liner 402 may be formed from porous or nonporous material, which may be non-degradable or degradable, as desired. For example, the liner 402 may be formed from a polymeric material, such as ePTFE, urethane, and the like. Optionally, the liner 402 (and / or frame 401) and / or the other components of closure device 300 may include one or more coatings, e.g., antithrombotic drugs, such as heparin, antibiotics, and / or other drugs that promote healing. Additionally, frame 401 and / or liner 402 may be optionally modified (e.g., via imparting a surface texture or other means known to the art) to either reduce turbulent flow over the frame 401 or liner 402, or to enhance the endothelization and eventual integration of the components into the vessel wall. Such modifications may include bonding cell signaling moi eties (e.g., vascular endothelial growth factor(s) and the like) to the surface of frame 401 or liner 402 or incorporating suchmoieties into the internal structure of the components themselves. For example, the sealant component of the closure device may include cell signaling ligands (e.g., growth factors, cytokines, chemokines, etc.) to improve the integration of the sealing component into the surrounding tissue and accelerate wound healing.[000122] The liner 402 may cover one or more of the upper and lower surfaces of the frame 401 and may be attached to the frame 401 by one or more of heat fusing, spin coating, dip coating, spray coating, deposition, adhesive bonding, and the like, to provide a cover having a desired thickness, e.g., between about 0.0005-0.010 inch (0,0125-0.25 mm).[000123] With particular reference to FIGS. 4-2 and 4-3, the frame 401 may include an elongate spine or central region 404 including opposite ends 404a aligned along a longitudinal axis 400a of the footplate 400. The spine 404 may have sufficient length to facilitate orienting the footplate 400 within a body lumen, e.g., to automatically align the ends 404a and axis 400a along the length of the body lumen when the footplate 400 is deployed and pulled against the wall of the body lumen, similar to other footplates herein.[000124] One or more openings 403 may be formed in the spine 404, e.g,, for receiving one or more filaments 209, as shown in FIG. 4-1. For example, as shown in FIG.4-2, two axial slots 403 may be formed in the spine 404, e.g., to provide an elongate tab 406 within each slot 403 that extend the length of each slot 403, yet accommodate inserting a filament through the slot 403 to couple the footplate 400 to the other components of the closure implant. Alternatively, as shown in FIG. 4-3, relatively short tabs 406 may be formed in the spine 404, which may be bent or otherwise deformed out of the plane of the spine 404, such that the slots 403 remain open.[000125] Optionally, the frame 401 may include a pair of fins or wings 405 extending from opposite sides of the spine 404 between the ends 404a. The fins or wings 405 may be configured to cover the intimal tear and prevent the direct interaction of blood to the injured vessel (i.e., vessel tear), which may initiate thrombus formation. In the example shown in FIGS. 4-2 and 4-3, the fins 405 include curved elements extending from the spine 404 including a channel or opening between the fins 405 and the spine 404, which may facilitate shaping the fins 405 in a desired shape. For example, as best seen in FIG. 4-3, the fins 405 may curve out of a plane of the spine 404, e.g., to provide a curved surface for facilitating placement against the wall of the body lumen. Optionally, the spine 404 may also be curved in a direction orthogonal to the axis 400a to further facilitate placement against a vessel wall.- JJ[000126] Optionally, as shown in FIGS. 4-5a to 4-5c, the spine 404 may include additional openings, such as a pair of channels 409 extending axially along the spine 404 on opposite sides of the slots 403, which may enhance flexibility of the footplate 400.[000127] Optionally, the fins 405 may include one or more spikes or other projections, e.g., a plurality of anchor spikes 410 spaced apart from one another along each fin 405, as shown in FIG. FIG 4-6, which may facilitate securement of the footplate to the vessel wall to prevent potential migration of the footplate in the blood stream. The anchor spikes 410 may also stabilize the intima to the media / extema and prevent propagation of intimal tears as discussed herein. The anchor spikes may be formed as part of the footplate by a variety of methods, including one or more of laser cutting, stamping, injection molding, and the like. The anchor spikes 410 may also be added to the footplate using a joining method that may include, but not limited to, welding, soldering, gluing, and the like.[000128] Turning to FIGS. 5A-5C, another example of a closure implant 360 and delivery catheter or device 370 are shown that may be used to seal a vascular puncture, similar to other examples herein. Similar to other closure implants herein, the implant 360 generally includes a sealant 363 and a footplate 361, which may be constructed similar to any of the examples described elsewhere herein. Unlike other examples, the sealant 363 is coupled to the footplate 361 by one or more filaments 362, e.g., such that the sealant 363 initial contacts an upper surface of the footplate 361. In various examples, the footplate 361 may be a disc or sheet; having a circular, oval, or composite shape; which may be biased to a convex shape or may be flexible to conform to a vessel wall that is similar to the curvature of the inner surface of a blood vessel or other body lumen. The footplate 361 may be formed from similar materials to other footplates herein, and, in one particular example, may be relatively thin and have a substantially uniform thickness, e.g., to facilitate placing the footplate 361 against the wall of a vessel at an arteriotomy.[000129] The sealant 363 may be formed as a plug or other cylindrical or otherwise shaped elongate body made from a degradable or non-degradable polymer, such as PEG. In the example shown, a single filament 362 extends from the footplate 361 and passes through the sealant 363 along its length, e.g., between a proximal end 363a and distal end 363b of the sealant 363. The filament 362 also secures the sealant 363 to the footplate 361 to inhibit separation between the sealant 363 and the footplate 361, e.g., to prevent a substantial gap from forming between the distal end 363b and the footplate 361.[000130] In addition, the implant 360 may also include an external anchor 364 that may also be coupled to filament 362, such that the sealant 363 is positioned between the external anchor 364 and the footplate 361. The filament 362 may pass through a central portion of the external anchor 364, such that the external anchor 364 is slidable along the filament 362 towards the sealant 363, as described further below. The external anchor 364 may have one or more arms 364a that expand outwards from a compressed state to aid in the securement of the sealant and ensure hemostasis. The arms 364a may be formed from wire, tubes, flaps, or the like. The arm material may be elastic, superelastic, or have shape memory properties that allow the arms to compress or fold to a lower profile when sheathed in the delivery catheter 370 and expand to a larger profile when unsheathed. For example, the arms may be formed from material that is polymeric, metal, or a combination thereof; and may be resorbable or non-resorbable.[000131] Disposed proximal to the external anchor 364 is a tamp stop 366 that is secured to the filament 362 by adhesive bonding, fusing, and the like such that the tamp stop 366 does not move axially relative to the filament 362, The distal end 366b of the tamp stop 366 may initially abut the proximal end of the external anchor 364, e.g., preventing proximal movement of the external anchor 364 and sealant 363 during the closure procedure.[000132] Also abutting the proximal end of the external anchor 364 is a tamp lock 365, which is disposed slidably over the tamp stop 366. Distal movement of the tamp lock 365 drives the external anchor 364 forward to compress the sealant 363 against the footplate 361. The proximal end 365a of the tamp lock 365 comprises one or more detents, ratchets, locks, or other features that allow the tamp lock 365 to traverse distally over the tamp stop 366 but prevent the tamp lock 365 from traversing proximally over the tamp stop 366 once the proximal end 365 a of the tamp lock 365 has traversed the distal end 366b of the tamp stop 366,[000133] The tamp lock 365 is advanced using a tamping tube 367 that is disposed proximal to the tamp lock 365, as shown in FIGS, 5B and 5C. FIG. 5B shows a cross sectional view of the distal portion of the closure device 360. FIG. 5C further shows the distal components of the closure device delivery system (not including the handle and other components, e.g., which may be similar to those shown in FIGS. 2-1 b and 2-lc), showing the tamping tube 367, an inner jacket or tubular member 368, and an outer jacket or tubular member 369 of the delivery device 370 in their initial positions. The inner jacket 368 isslidably disposed over the filament 362, sealant 363, external anchor 364, tamp lock 365, tamp stop 366, and tamping tube 367. The outer jacket 369 is slidably disposed over the inner jacket 368. Both the inner jacket 368 and outer jacket 369 serve to sheath the inner components during the delivery of the closure implant 360. Optionally, the inner jacket 368 may include one or more longitudinal slits (not shown) extending distally from the distal tip of the inner jacket 368, e g., at least partially along the sealant 363, which may facilitate withdrawing the inner jacket 368 from over the sealant 363, as described elsewhere herein.[000134] Turning to FIGS. 6A-6D, an exemplary method is shown for sealing a puncture 90 through tissue communicating with a blood vessel or other body lumen 94, similar to other closure implants and delivery devices described elsewhere herein. The closure implant 360 may be initially provided within a delivery device similar to the closure device 200 as shown in FIGS. 2-1 to 2-lc.[000135] In FIGS. 6A and 6A-1, the footplate 361 has been deployed from the introducer sheath 218 within the vessel 94 and positioned against the vessel wall adj cent to the puncture 90, e.g., using steps similar to the other devices herein. Next, as shown in FIGS. 6B and 6B-1, the introducer sheath 218, outer jacket 369, and inner jacket 368 are then retracted proximally to expose the sealant 363, the external anchor 364, tamp lock 365, and tamping tube 367. Once exposed, the sealant 363 will begin to imbibe bodily fluid, both interstitial fluid in the tissue tract, and more so, blood from the puncture 90. In doing so, the sealant 363 will begin to expand and fill the space in the tissue tract. In this particular embodiment, the sealant 363 is secured to the footplate 361 to prevent separation between the two components. As such, the sealant 363 traverses the wall thickness of the puncture 90 and into the tissue tract. Upon expansion, the sealant 363 will therefore cork the puncture in filling the void in the body lumen wall. Once corked, the securement of the sealant 363 to the footplate 361 also minimizes the probability of the sealant 363 from being displaced due to relative motion between the body lumen and the surrounding tissue upon patient ambulation.[000136] Retraction of the introducer sheath 218, outer jacket 369, and inner jacket 368 also releases the external anchor arm(s) 364a of the external anchor 364, allowing the arms 364a to deploy radially. The deployed arms 364a enhance engagement of the external anchor 364 with the sealant 363 when the external anchor 364 is advanced distally to compress the sealant 363 against the wall of the vessel 94, as shown in FIGS. 6C and 6C-1, as well as expand the sealant radially to engage wall of the tissue tract.[000137] Compression of the sealant 363 is facilitated by advancing the tamping tube 367 distally until the tamp lock 365 traverses completely over the tamp stop 366. Once the tamp lock 365 has traversed the tamp stop 366; the tamp lock 365, external anchor 364, and sealant 363 are secured in place between the tamp stop 366 and the footplate 361. The footplate 361 prevents expulsion of the sealant 363 from the arteriotomy, while the arms 364a of the external anchor prevents the ingress of the sealant 363 into the body lumen.[000138] After compressing the sealant 363 and confirming hemostasis, the closure device delivery system components proximal to the tamp stop 366 are removed from the tissue tract. The filament 362 is then trimmed below the skin level leaving just the closure implant 360, as shown in FIGS. 6D and 6D-1.[000139] Optionally, the sealant, footplate, and / or other components of closure devices 360 or 370 may possess echogenic or radiopaque properties. The echogenicity and / or radiopacity of the device components may be achieved by any number of techniques known to the art; as an example, the addition of micronized or nanoscale metallic powders to a polyethylene glycol based sealant can provide a controlled degree of echogenicity and / or radi opacity to the sealant. The irregular nature of the solids dispersed within the relatively homogenous polymeric network serves to scatter incoming ultrasound waves and render the sealant visible to ultrasound. Similarly, the incorporation of materials that are radiopaque into the body of the sealant may render the sealant radiopaque as well. The degree of radiopacity and / or echogenicity exhibited by the sealant may be tuned to a desired degree by controlling the amount of echogenic or radiopaque dopant added to the sealant. In some cases, the choice of the doping material may provide echogenicity, radiopacity, or both. Alternatively, the surface of a given component may be modified to impart echogenicity, such as through the creation of a concentrated or disperse grouping of regular or irregular elevations and / or depressions, scratches or channels, dimples, through holes, and the like using methods well known in the art (e.g., sandblasting, machining, etching, etc.).[000140] Additionally, the individual components of closure device 360 or 370 may be optionally modified to enhance the endothelization and eventual integration of the components into the vessel wall. Such modifications may include bonding cell signaling moieties (e g., vascular endothelial growth factor(s) and the like) to the individual components of closure device 360 or 370, or incorporating such moieties into the internal structure of the components themselves. For example, the sealant component of the closure device may include cell signaling ligands (e.g., growth factors, cytokines, chemokines, etc.)to improve the integration of the sealing component into the surrounding tissue and accelerate wound healing.[000141] Optionally, in any of the exemplary devices and systems herein, one or more sutures may be placed through tissue, e.g., through the wall of the vessel being closed, to limit the progression of the intimal tear created and / or assist in targeting the vessel. For example, before or after initial introduction of a needle to initially access the vessel, one or more sutures may be placed. This initial intimal tear typically propagates in the radial direction while inserting an access sheath, which substantially dilates the arteriotomy to a larger size. These sutures may serve as a fence or guard to stop or limit the propagation of intimal tear in the radial direction usually created when a large access sheath is inserted. The advantages of limiting or reducing the length of intimal tear may include reducing trauma or minimizing vessel dissection that may potentially lead to undesirable clinical events. A smaller intimal tear may also provide an improved hemostasis outcome after deployment of a closure device. In one example, shown in FIG. 7A, after the introduction of the needle 501 in the vessel 502, a pair of suture loops 503 may be pl aced substantially parallel with each other and positioned on either side of the arteriotomy 504, e.g., with each suture loop orthogonal to the radial plane that is in line with the arteriotomy 504 created by the needle 501. The extravascular suture knot 505 for each suture loop 503 may then be tightened to secure the sutures in place. The suture loops 503 may be approximately the same length as the distance between the parallel sutures to ensure coverage of the tear 506 propagating radially. The pair of sutures are placed about equidistant from the arteriotomy 504 and spaced apart to accommodate the largest device (e.g., access sheath) to be inserted through the arteriotomy 504. As the pair of sutures are placed after the initial needle stick, the accuracy of suture placement relative to the arteriotomy is greatly enhanced since the arteriotomy can be used as the central point of reference. After the procedure, a closure device may be used to close the puncture site, e.g., similar to the devices and methods described elsewhere herein.[000142] In another example, prior to introduction of an access needle, a pair of sutures may be placed substantially parallel with each other and orthogonal to the radial plane. Similar to the first example, the stitch loops may be approximately the same length as the distance between the parallel sutures. The pair of sutures may be spaced substantially apart to accommodate the needle puncture and the largest device (e.g., introducer access sheath) to be inserted through the arteriotomy.?\s the sutures are placed substantiallyperpendicular to the direction of the intimal tear, the sutures thereby inhibit the tear propagation.[000143] In a third example, the pair of sutures may overlap each other near orthogonally, thereby creating a target location for the arteriotomy, such that, when the sutures are cinched / tightened, the intimal tear is limited in its progression. Upon completion of the interventi onal procedure, the set of sutures may be tied to close the arteriotomy. Subsequently, the extravascular sutures extending from the vessel wall may be used as a rail to deliver and secure a sealant such as PEG, collagen, and the like, on top of the arteriotomy to further ensure hemostasis.[000144] In a fourth example, a needle is used to create the initial arteriotomy, and with the needle still in place, a pair of sutures are placed orthogonal to each other and crossing over the needle, e.g., as shown in FIG. 7B. When the sutures are cinched / tightened, the intimal tear is limited in its progression. Upon completion of the interventional procedure, the set of sutures may be tied to close the arteriotomy.Subsequently, the extravascular sutures extending from the vessel wall may be used as a rail to deliver and secure a sealant such as PEG, collagen, and the like, on top of the arteriotomy to further ensure hemostasis.[000145] Turning to FIGS. 8-1 to 8-4, another example of a closure implant 601 and delivery catheter or device 600 are shown that may be used to seal a vascular puncture, similar to other embodiments provided herein. FIG. 8-1 provides an isometric transparent view of the distal components of the closure device delivery system (not including the handle and other components, as those were provided previously in FIGS. 2-lb and 2-1 c), showing bypass tube 621, inner jacket or tubular member 617, and outer jacket or tubular member 613 of delivery device 600 in their initial positions. In FIG, 8-1, bypass tube 621 is slidably disposed over all the distal components of the closure device delivery system, inner jacket 617 is slidably disposed over filament 603, sealant 615, external anchor 611, compression spring 609, tamp lock 605, tamp stop 607, and tamping tube 602, and outer jacket 613 is slidably disposed over the inner jacket 617. Both inner jacket 617 and outer jacket 613 serve to sheath the inner components during the delivery of the closure implant 601. Optionally, inner jacket 617 may include one or more longitudinal slits (not shown) extending distally from the distal tip of the inner jacket 617, e.g., at least partially along the sealant 615, to facilitate withdrawing the inner jacket 617 from over the sealant 615, as previously described herein. Optionally, the tip of inner jacket 617 and outer jacket 613may be formed by trimming, tipping, crimping, die forming, and the like, to provide distal coverage of the sealant 615. The formed tip may also facilitate positioning of footplate 619 when footplate 619 abuts the tip.[000146] FIGS. 8-2 to 8-4 provide a sequential illustration of the deployment of delivery catheter or device 600. FIG. 8-2 shows a cross sectional view of the distal portion of delivery catheter 600 in its initial, sheathed configuration with footplate 619 shown in apposition against vessel wall 623. FIG. 8-3 shows a cross section view of the distal portion of delivery catheter 600 in its unsheathed configuration, wherein sealant 615 is exposed within the arteriotomy and the extravascular tissue bed, and external anchor arms 612 of the external anchor are released within the tissue track, fully exposing closure implant 601. FIG. 8-4 then shows a cross section view of closure implant 601 in the fully deployed state, wherein tamp lock 605 has been advanced over tamp stop 607, sealant 615 and spring 609 are in a compressed state, and external anchor arms 612 of external anchor 611 are expanded and engaged with surrounding extravascular tissue 625 above vessel wall 623.[000147] Similar to other closure implant embodiments provided herein, implant 601 generally includes a sealant 615 and a footplate 619, which may be constructed similar to any of the examples described elsewhere herein. Similar to closure implant 360 in FIG 5 A, sealant 615 is coupled to footplate 619 by one or more filaments 603, e.g., such that the sealant 615 initially contacts an upper surface of footplate 619.[000148] As described previously, the geometry of footplate 619 may be a sheet having a circular, oval, or composite shape; which may be biased to a convex shape or may be flexible to conform to a vessel wall that is similar to the curvature of the inner surface of a blood vessel or other body lumen. The footplate 619 may be formed from similar materials to other footplates herein, and, in one particular example, may be relatively thin and have a substantially uniform thickness, e.g., to facilitate placing the footplate 619 against the wall of a vessel at an arteriotomy.[000149] The sealant 615 may be formed, as previously described herein, as a plug or other cylindrical or otherwise shaped elongate body made from a degradable or non-degradable polymer, such as PEG. As described previously, a single filament 603 extends from footplate 619 and passes through sealant 615 along its length, e.g., between a proximal end 615a and distal end 615b of sealant 615. The filament 603 also secures the sealant 615 to footplate 619 to inhibit separation between sealant 615 and the footplate 619, e.g., to prevent a substantial gap from forming between the distal end 615b and footplate 619.[000150] In addition, as previously described, implant 601 may also include an external anchor 611 that may also be coupled to filament 603, such that the sealant 615 is positioned between external anchor 611 and footplate 619. Filament 603 may pass through external anchor 611, such that external anchor 611 is slidable along filament 603 towards the sealant 615, as described further below. External anchor 611 may have one or more external arms 612 that expand outwards from a compressed state to aid in the securement of the sealant and ensure hemostasis. External arms 612 may be formed from wire, tubes, flaps, or the like and may comprise features such as flares, barbs, spikes, changes in surface roughness, and the like that may enhance the ability of external anchor 611 to maintain a desired position within the tissue tract. External arms 612 may further comprise membranes or coverings to increase the surface area of external arms 612 that are contact with either the sealant 615 or the tissue tract. The material used to construct external arms 612 may include, but is not limited to, those that possess elastic, superelastic, or shape memory properties allowing external arms 612 to compress or fold to a lower profile when sheathed in inner jacket 617 and outer jacket 613, and then expand to a larger profile when unsheathed. For example, external arms 612 may be formed from material that is polymeric, metallic, or combinations thereof well characterized in the art; and may be resorbable or non-resorbable. External arms 612 may be fabricated using methods well known to the art, including but not limited to, wire forming, injection molding, laser cutting, additive manufacturing, overmolding, heat treating, combinations thereof, and the like.[000151] As shown in FIGS 8-2 to 8-4, compression spring 609 is disposed proximal to external anchor 611 and may be positioned over, or within, the proximal end 611 a of the external anchor 611. Compression spring 609 may be formed from material that is polymeric, metallic, or combinations thereof well characterized in the art; and may be resorbable or non-resorbable. The distal end 609b of compression spring 609 may be secured to external anchor 611 using manufacturing methods well characterized in the art, including but not limited to, adhesive bonding, thermal fusing, soldering, and the like. The distal end 609b of the compression spring 609 may also be freely coupled to the proximal end 611a of the external anchor 611 by having an overlapping length over the proximal body of the external anchor 611 or within the proximal body of the external anchor 611.[000152] Disposed proximal to compression spring 609 is tamp lock 605, wherein the proximal end 609a of compression spring 609 may be positioned over, or within, the distal end 605b of the tamp lock 605. The proximal end 609a of the compression spring 609 maybe secured to tamp lock 605 using manufacturing methods well characterized in the art, including but not limited to, adhesive bonding, thermal fusing, soldering, and the like. The proximal end 609a of the compression spring 609 may also be freely coupled to the distal end 609b of the tamp lock 605 by having an overlapping length over the distal body 609b of tamp lock 605, or within the distal body 609b of tamp lock 605.[000153] Also disposed between external anchor 611 and tamp lock 605 is tamp stop 607 that is secured to filament 603 by using manufacturing methods well characterized in the art, including but not limited to, adhesive bonding, thermal fusing, and the like such that tamp stop 607 does not move axially relative to filament 603. The distal end 607b of tamp stop 607 may initially abut the proximal end of external anchor 611, e.g., preventing proximal movement of external anchor 611 and sealant 615 during the closure procedure. However, tamp stop 607 may be positioned anywhere between external anchor 611 and tamp lock 605, wherein the tamping distance is determined as the distance between the distal end 607b of tamp stop 607 and the proximal end 605a of tamp lock 605 in the initial assembled state. Tamp lock 605 is disposed slidably over the tamp stop 607 such that tamp stop 607 may be positioned within the body of the tamp lock 605 distal to proximal end 605a in the initial assembled state.[000154] Tamp lock 605 is advanced using tamping tube 602 that is disposed proximal to tamp lock 605, as shown in FIGS. 8-1 and 8-2. Distal movement of tamp lock 605 drives compression spring 609 and external anchor 611 forward to compress the sealant 615 against footplate 619. The proximal end 605a of tamp lock 605 comprises one or more detents, ratchets, locks, or other features that allow tamp lock 605 to traverse distally over tamp stop 607, but prevents tamp lock 605 from traversing proximally over tamp stop 607 once the proximal end 605a of tamp lock 605 has traversed the distal end 607b of tamp stop 607. In this locked state, sealant 615, external anchor 611, compression spring 609, and tamp lock 605 are secured between footplate 619 and tamp stop 607.[000155] In the locked state, if the columnar strength of sealant 615 is higher than the spring rate of the compression spring 609, the spring 609 will compress before the sealant 615. However, sealant 615 softens, and its columnar strength decreases, as it imbibes blood and / or interstitial fluid. As such, when the columnar strength of sealant 615 decreases below the spring rate of spring 609, spring 609 will advance external anchor 611 to compress sealant 615 against footplate 619 and further embeds at least a portion of external anchor arms 612 into the surrounding extravascular tissue 625. In turn, compression spring609 also exerts an equal and opposite force on tamp lock 605 and tamp stop 607. When the distal advancement force from spring 609 onto the external anchor 611 and sealant 615 plateaus and external anchor 611 is substantially fixed in position within the tissue tract, the proximal force exerted by spring 609 onto tamp lock 605 and tamp stop 607 will tension filament 603, via the secured tamp stop 607, so as to pull footplate 619 proximally against vessel wall 623 to enhance hemostasis. The spring rate of the compression spring 609 may be selected to achieve the desired compression of the sealant 615 and the tensioning of the footplate 619 against the vessel wall 623. An advantage of this embodiment is that the design enables a method in which the active application of continuous force via the potential energy stored within compression spring 609 maintains the apposition of footplate 619 against the inside of vessel wall 623 to ensure hemostasis in cases where articulation or movement of the implant alters the initial implant geometry. For example, a device that does not comprise a mechanism to provide the active application of continuous force on the vessel in the face of articulation or movement may be prone to permitting pathways for blood to extravasate around the footplate if the relative force between the intravascular anchor and extravascular anchor (or other means of securement) diminishes over time.[000156] Although the embodiments of this invention described herein comprise a sealant material, it is envisioned that the device constructs described herein may be constructed to be functional without said sealant. In these alternative embodiments, hemostasis of the artery is achieved through the application of a continuous force between the footplate and the external anchor.[000157] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

1. WE CLAIM:

1. A device for sealing a puncture through a wall of a body lumen, comprising: an outer first member comprising a first proximal end, a first distal end sized for introduction into the puncture, and a first lumen extending between the first proximal end and the first distal end;a bypass tube carried on the first distal end such that a tubular portion of bypass tube extends distally beyond the first end, the tubular portion comprising a passage communicating with the first lumen;an inner second member slidably disposed within the first lumen, the second member comprises a second proximal end, a second distal end positioned within the first lumen adjacent the first distal end, and a second lumen extending between the second proximal end and the second distal end;a handle on the second proximal end comprising an actuator coupled to the first proximal end;a tamping member within the second lumen; anda closure implant comprising a biodegradable sealant within the second lumen adjacent the second distal end, a footplate disposed distal to the sealant within the passage distal to the first distal end, and a filament coupled between the sealant and the footplate and extending proximally through the second lumen to the handle,the bypass tube slidable proximally over the first member to deploy the footplate from the passage,the actuator movable to direct the first member proximally relative to the second member to expose the second distal end within the puncture,the second member movable proximally relative to the tamping member to expose the sealant within a puncture and expose the tamping member to allow advancement of the tamping member to compress the sealant towards the footplate.2, The device of claim 1, wherein the sealant comprises a sheet of biodegradable polymer rolled, folded, and / or otherwise compressed within the second lumen.

3. The device of claim 1, wherein the footplate is non-degradable.

4. The device of claim 1, wherein the footplate is biodegradable.

5. The device of claim 1, wherein the filament is non-degradable.

6. The device of claim 1, wherein the filament is biodegradable.

7. The device of any preceding claim, wherein the closure implant further comprises a lock member proximal to the sealant within the second lumen and slidable distally over the filament when the tamping member is advanced to compress the sealant between the lock member and the footplate.

8. The device of claim 7, wherein the lock member is non-degradable.

9. The device of claim 7, wherein the lock member is biodegradable.

10. The device of claim 7, further comprising a knot on the filament proximal to the lock member to prevent proximal movement of the lock member away from the sealant.

11. The device of any preceding claim, further comprising a pulley within the handle coupled to the filament such that, when the handle is moved proximally, filament wrapped around the pulley is released to accommodate directing the second member proximally to fully expose the tamping member.

12. The device of any preceding claim, wherein the closure implant further comprises a gasket at least partially surrounding the footplate within the passage.

13. The device of claim 12, wherein the gasket is configured to automatically open when the footplate is deployed within the body lumen.

14. The device of any one of claims 1-11, wherein the footplate comprises: a frame comprising an elongate sheet including first and second ends, the frame formed from elastic material such that the frame is biased to a deployed configuration tofacilitate positioning the frame against a wall of a body lumen and resiliently compressible to a delivery configuration for loading into the passage of the bypass tube; anda cover at least partially covering the frame.

15. The device of claim 14, wherein the frame comprises a central region extending between the first and second ends along an axis and a pair of fins extending laterally from opposite sides of the central region between the first and second ends.

16. The device of claim 15, wherein the central region lies within a plane in the deployed configuration and the fins curved out of the plane in the deployed configuration.

17. The device of claim 15, wherein the central region and the fins are curved orthogonal to the axis in the deployed configuration.

18. The device of claim 15, further comprising one or more openings through the central region for receiving the filament.

19. The device of claim 18, wherein the one or more openings comprise a slot through the central region aligned along the axis.

20. The device of claim 18, wherein the one or more openings comprise a pair of slots through the central region spaced apart from one another and aligned along the axis.

21. The device of claim 19, further comprising a tab extending from each slot.

22. The device of claim 21, wherein the tab extends from the slot laterally relative to the central region.

23. The device of claim 15, wherein the fins comprise a plurality of anchor spikes or other projections configured to facilitate securement of the footplate to the wall of the body lumen to prevent potential migration of the footplate and / or to stabilize the intima of the body lumen.

24. The device of claim 14, wherein the elastic material comprises superelastic Nitinol with an Af temperature set such that the elastic material is in an austenitic state at body temperature and in a martensitic state at or below room temperature.

25. The device of claim 14, wherein the cover comprises a coating including one or both of an antithrombotic drug or a drug that promotes healing.

26. The device of any one of claims 1 -11, wherein one or more components of the closure implant comprise echogenic and / or radiopaque material.

27. The device of claim 26, wherein the echogenic material comprises doping material within the sealant to provide echogenicity and / or radiopacity to the sealant.

28. The device of claim 27, wherein the material comprises micronized tantalum powder.

29. The device of any one of claims 1 -11, wherein one or more components of the closure implant comprise one or more surface treatments to enhance echogenicity of the one or more components.

30. The device of claim 29, wherein the one or more surface treatments comprise one or more of through-holes, dimples, depressions, and textured surfaces on the footplate.

31. A closure implant for sealing a puncture through tissue communicating with a body lumen, comprising:a sealant;a footplate; anda filament coupled between the sealant and the footplate,wherein the footplate comprises:a frame comprising an elongate sheet including first and second ends, the frame formed from elastic material such that the frame is biased to a deployed configuration to facilitate positioning the frame against a wall of a body lumen and resiliently compressible to a delivery configuration for loading into the passage of the bypass tube; anda cover at least partially covering the frame.

32. The closure implant of claim 31, wherein the frame comprises a central region extending between the first and second ends along an axis and a pair of fins extending laterally from opposite sides of the central region between the first and second ends.

33. The closure implant of claim 32, wherein the central region lies within a plane in the deployed configuration and the fins curved out of the plane in the deployed configuration.

34. The closure implant of claim 32, wherein the central region and the fins are curved orthogonal to the axis in the deployed configuration.

35. The closure implant of any of claims 32-34, further comprising one or more openings through the central region for receiving the filament.

36. The closure implant of claim 35, wherein the one or more openings comprise a slot through the central region aligned along the axis.

37. The closure implant of claim 35, wherein the one or more openings comprise a pair of slots through the central region spaced apart from one another and aligned along the axis.

38. The closure implant of claim 36, further comprising a tab extending from each slot.

39. The closure implant of claim 38, wherein the tab extends from the slot laterally relative to the central region.

40. The closure implant of any one of claims 32-34, wherein the fins comprise a plurality of anchor spikes or other projections configured to facilitate securement of thefootplate to the wall of the body lumen to prevent potential migration of the footplate and / or to stabilize the intima of the body lumen.

41. The closure implant of any one of claims 31-34, wherein the elastic material comprises superelastic Nitinol with an Af temperature set such that the elastic material is in an austenitic state at body temperature and in a martensitic state at or below room temperature.

42. The closure implant of any one of claims 31-34, wherein the sealant is biodegradable.

43. The closure implant of any one of claims 31-34, wherein the sealant is non-degradable.

44. The closure implant of any one of claims 31 -34, wherein one or more components of the closure implant comprise echogenic and / or radiopaque material.

45. The closure implant of claim 44, wherein the echogenic material comprises doping material within the sealant to provide echogenicity and / or radiopacity to the sealant.

46. The closure implant of claim 45, wherein the material comprises micronized tantalum powder.

47. The closure implant of any one of claims 31 -34, wherein one or more components of the closure implant comprise one or more surface treatments to enhance echogenicity of the one or more components.

48. The closure implant of claim 47, wherein the one or more surface treatments comprise one or more of through-holes, dimples, depressions, and textured surfaces on the footplate.

49. A closure implant for sealing a puncture through tissue communicating with a body lumen, comprising:a sealant;a footplate; anda filament coupled between the sealant and the footplate,wherein one or more components of the closure implant comprise echogenic and / or radiopaque material.

50. The closure implant of claim 49, wherein the echogenic material comprises doping material within the sealant to provide echogenicity and / or radiopacity to the sealant.

51. The closure implant of claim 50, wherein the material comprises micronized tantalum powder.

52. A closure implant for sealing a puncture through tissue communicating with a body lumen, comprising:a sealant;a footplate; anda filament coupled between the sealant and the footplate,wherein one or more components of the closure implant comprise one or more surface treatments to enhance echogenicity of the one or more components.

53. The closure implant of claim 52, wherein the one or more surface treatments comprise one or more of through-holes, dimples, depressions, and textured surfaces on the footplate.

54. A closure implant for sealing a puncture through tissue communicating with a body lumen, comprising:a footplate;a filament coupled to the footplate;a stop attached to the filament spaced apart from the footplate;an anchor slidably disposed on the filament distal to the stop;a sealant on the filament between the anchor and the footplate such that a proximal end of the sealant abuts the anchor and a distal end of the sealant is positioned adjacent the footplate; anda tamp lock slidably disposed over the filament proximal to the anchor such that distal advancement of the tamp lock directs the anchor distally to compress the sealant between the anchor and the footplate.

55. The closure implant of claim 54, wherein the anchor comprises one or more expandable arms that overly the proximal end of the sealant in a compressed state and are biased to expand away from the sealant.

56. The closure implant of claim 55, wherein the one or more arms comprise a pair of arms including first ends coupled to the anchor and second free ends that extend distally over the sealant in the compressed state.

57. The closure implant of any one of claims 54-56, wherein the tamp lock comprises one or more features that engage the stop when the tamp lock is advanced to prevent subsequent proximal movement of the tamp lock.

58. The closure implant of claim 57, wherein the tamp lock comprises a tubular member sized to slide over the stop and wherein the one or more features comprise one or more detents on a proximal end of the tubular member.

59. The closure implant of claim 58, wherein the tubular member has an inner passage that slidably receives the stop when the tubular member is advanced distally, and wherein a distal end of the tubular member is configured to abut the anchor to advance the anchor when the tubular member is advanced distally.

60. The closure implant of any one of claims 54-56, wherein the sealant is attached to the filament such that the distal end of the sealant is positioned against an upper surface of the footplate.

61. A device for sealing a puncture through a wall of a body lumen, comprising: an outer first member comprising a first proximal end, a first distal end sized for introduction into the puncture, and a first lumen extending between the first proximal end and the first distal end;a bypass tube carried on the first distal end such that a tubular portion of bypass tube extends distally beyond the first end, the tubular portion comprising a passage communicating with the first lumen;an inner second member slidably disposed within the first lumen, the second member comprises a second proximal end, a second distal end positioned within the passage and sized for introduction through the puncture into the body lumen, and a second lumen extending between the second proximal end and the second distal end;a closure implant comprising a footplate; a filament coupled to the footplate; a stop attached to the filament spaced apart from the footplate; an anchor slidably disposed on the filament distal to the stop; a sealant on the filament between the anchor and the footplate such that a proximal end of the sealant abuts the anchor and a distal end of the sealant is positioned adjacent the footplate; and a tamp lock slidably disposed over the filament proximal to the sealant, anchor, and the footplate; and the tamp lock is positioned within the second lumen with a distal end of the sealant is positioned immediately adjacent an outlet of the second distal end and the filament extends proximally through the second lumen, and the footplate is positioned within the passage such that an attachment location of the filament is located immediately adjacent the outlet; anda tamping member within the second lumen proximal to the tamp lock, wherein the bypass tube is slidable proximally over the first member to deploy the footplate from the passage within the body lumen and the second member is movable proximally relative to the tamping member to expose the sealant within a puncture and expose the tamping member to allow advancement of the tamping member to advance the tamp lock to direct the anchor distally to compress the sealant between the anchor and the footplate.

62. The device of claim 61, wherein the anchor comprises one or more expandable arms that overly the proximal end of the sealant in a compressed state within the second lumen and are biased to expand away from the sealant when exposed within the puncture.

63. The device of claim 62, wherein the one or more arms comprise a pair of arms including first ends coupled to the anchor and second free ends that extend distally over the sealant in the compressed state.

64. The device of any one of claims 61-63, wherein the tamp lock comprises one or more features that engage the stop when the tamp lock is advanced by the tamping member to prevent subsequent proximal movement of the tamp lock,65. The device of claim 64, wherein the tamp lock comprises a tubular member sized to slide over the stop and wherein the one or more features comprise one or more detents on a proximal end of the tubular member,66. The device of claim 65, wherein the tubular member has an inner passage that slidably receives the stop when the tubular member is advanced distally, and wherein a distal end of the tubular member is configured to abut the anchor to advance the anchor when the tubular member is advanced distally.

67. The device of any one of claims 61-63, wherein the sealant is attached to the filament such that the distal end of the sealant is positioned against an upper surface of the footplate such that the distal end of the sealant is positioned within the puncture in the wall of the body lumen when the footplate is positioned against the wall.

68. A closure implant for sealing a puncture through tissue communicating with a body lumen, comprising:a footplate;a filament coupled to the footplate;a stop attached to the filament spaced apart from the footplate;an anchor slidably disposed on the filament distal to the stop;a sealant on the filament between the anchor and the footplate such that a proximal end of the sealant abuts the anchor and a distal end of the sealant is positioned adjacent the footplate;a compression spring slidably disposed over the filament proximal to the anchor; and,a tamp lock slidably disposed over the filament proximal to the compression spring such that distal advancement of the tamp lock directs the compression spring and anchor distally to compress the sealant between the anchor and the footplate.

69. The closure implant of claim 68, wherein the anchor slidably receives the distal end of the compression spring.

70. The closure implant of claim 68, wherein the anchor is rigidly coupled to the distal end of the compression spring.

71. The device of claim 69 or 70, wherein the tamp lock slidably receives the proximal end of the compression spring.

72. The device of claim 69 or 70, wherein the tamp lock is rigidly coupled to the proximal end of the compression spring.

73. The closure implant of claim 68, wherein the compression spring has a spring constant greater than the stiffness of the sealant in the hydrated and non-hydrated state.

74. The closure implant of claim 68, wherein the compression spring has a spring constant greater than the stiffness of the sealant in the hydrated state, but less than the stiffness of the sealant in the non-hydrated state.

75. The device of claim 73 or 74, wherein the compression spring has a spring constant sufficient to tension the footplate against body lumen wall.

76. The device of claim 73 or 74, wherein the compression spring applies continuous tension to the footplate against body lumen wall.

77. A closure implant for sealing a puncture through tissue communicating with a body lumen, comprising:a footplate;a filament coupled to the footplate;a stop attached to the filament spaced apart from the footplate;an anchor slidably disposed on the filament distal to the stop;a compression spring slidably disposed over the filament proximal to the anchor; and,a tamp lock slidably disposed over the filament proximal to the compression spring such that distal advancement of the tamp lock directs the compression spring and anchor distally to compress the spring between the anchor and the footplate.

78. A method for sealing a puncture through tissue communicating with a body lumen, using a system comprising:a footplate;a filament coupled to the footplate;a stop attached to the filament spaced apart from the footplate;an anchor slidably disposed on the filament distal to the stop;a sealant on the filament between the anchor and the footplate such that a proximal end of the sealant abuts the anchor and a distal end of the sealant is positioned adjacent the footplate;a compression spring slidably disposed over the filament proximal to the anchor; and,a tamp lock slidably disposed over the filament proximal to the compression spring such that distal advancement of the tamp lock directs the compression spring and anchor distally to compress the sealant between the anchor and the footplate,wherein, the compression spring provides active application of a continuous force via the potential energy stored within the compression spring to maintain hemostasis via apposition of the footplate against the inside of the vessel wall.

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