Vascular closure devices and methods

Abstract

A vascular closure assembly may include an actuator assembly having a chassis portion and an elongated housing having a proximal end secured to a distal end of the chassis portion, a distal end distal from the chassis portion, a distal section, and a plurality of anchor deployer lumens. Each anchor deployer lumen extends in an axial direction of the elongated housing or in other suitable path and terminates distally at a distal port disposed in a distal section of the elongated housing. The actuator assembly may also include a plurality of anchor deployers, each anchor deployer slidably disposed within a corresponding anchor deployer lumen of the elongated housing. Each anchor deployer may include a deployment rod having an elongate resilient configuration and a preformed distal section that assumes a curved profile when in a relaxed state.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 420,391, filed Oct. 28, 2022, by B. Hauck et al., entitled "Large Bore Closure Devices and Methods", the entire disclosure of which is incorporated herein by reference. Background of the Invention

[0003] In many percutaneous procedures, a catheter is inserted into an access hole in a blood vessel (e.g., the femoral artery). Such percutaneous procedures may include minimally invasive cardiovascular procedures such as, for example: balloon angioplasty procedures, atherectomy procedures, cardiovascular stent deployments, heart valve replacements, stent graft deployments, and others. During such procedures, a treatment catheter may typically be inserted directly into the artery over a guide wire, or the catheter may be inserted through a vascular introducer sheath. When the treatment procedure is complete, the physician typically removes the treatment catheter and then, if an introducer sheath was used, removes the introducer sheath from the blood vessel. The physician must then prevent or limit the amount of blood leaking through the vascular access hole in the wall of the affected blood vessel. Physicians currently use a variety of methods to close the vascular access hole or otherwise limit bleeding through the access hole after the procedure, such as local external compression, suture-mediated closure devices, direct suture-mediated incision, plugs, gels, foams, and similar materials.

[0004] However, such closure procedures can be time-consuming and may consume a significant portion of the procedure time. In addition, some existing methods are associated with complications such as hematomas or thrombi. Further still, some such procedures, particularly suture-mediated closure devices, are known to have a high failure rate in the presence of common vascular diseases such as atherosclerosis and calcification. There is a need for methods and devices that can be used to effectively and conveniently close the vascular access hole after the procedure is complete. Summary of the Invention

[0005] Some embodiments of a vascular closure assembly may include an actuator assembly having a chassis portion and an elongate housing, a proximal end of the elongate housing being fixed to a distal end of the chassis portion, a distal end extending away from the chassis portion, a distal section, and a plurality of anchor deployer lumens. Each anchor deployer lumen may extend axially along the elongate housing or along any other suitable path and terminate distally at a distal port disposed in the distal section of the elongate housing. The actuator assembly may further include a plurality of anchor deployers, each anchor deployer being slidably disposed within a respective anchor deployer lumen of the elongate housing. Each anchor deployer may include a deployment rod having an elongate elastic configuration and a preformed distal section that presents a curved profile when in a relaxed state.

[0006] The preformed distal segment may also have a straightened profile when in a constrained state within a corresponding anchor deployer lumen and may be configured to extend along a curved path from a corresponding distal port of the anchor deployer lumen when an extension portion of the preformed distal segment relaxes and assumes a curved profile. The anchor deployer may also include an anchor removably secured to the distal end of the deployment rod and configured to resist proximal retraction within tissue. A respective wire may be secured to each anchor of the anchor deployer.

[0007] Some embodiments of a vascular closure assembly may have an actuator assembly including a chassis portion and a plurality of anchor deployers, each anchor deployer including a deployment rod, an anchor removably secured to the distal end of the deployment rod, and a wire secured to each anchor. The actuator assembly may also include an elongate housing having a proximal end, a distal end, and a lumen extending along the elongate housing to the distal end of the elongate housing, the proximal end being secured to the distal end of the chassis portion. The actuator assembly may also include a plurality of anchor deployer lumens configured to be slidably disposed about respective anchor deployers, each anchor deployer lumen extending along the elongate housing and terminating distally in a distal port disposed in a distal segment of the elongate housing.

[0008] A plurality of wire retainers may be disposed on an outer surface of the elongate housing, proximate the distal ports of the anchor deployer lumens. In some instances, each wire retainer may be configured to releasably secure a portion of a respective wire.

[0009] Some embodiments of a vascular closure assembly may include an inner catheter assembly having a longitudinal axis with a proximal end, a distal end, a distal segment, an axial length, and a guidewire lumen extending proximally from a distal port at the distal end of the longitudinal axis to a proximal port disposed in the distal segment. The vascular closure assembly may also include an actuator assembly having a chassis portion and a plurality of anchor deployers, each anchor deployer including a deployment rod, an anchor removably secured to the distal end of the deployment rod, and a wire secured to each anchor.

[0010] The actuator assembly may also have an elongate housing that includes a proximal end, a distal end, and a lumen extending along the elongate housing to the distal end of the elongate housing. The proximal end is fixed to the chassis portion. The lumen has an inner surface profile configured to slidably receive an outer surface of the long shaft. The elongate housing may also include a plurality of anchor deployer lumens configured to slidably receive corresponding anchor deployers. Each anchor deployer lumen extends along the elongate housing and terminates distally in a distal port disposed in the distal section of the elongate housing. The elongate housing may include a guidewire release slot disposed in the lumen through a wall portion of the lumen and extending proximally from the distal end of the lumen to a proximal end of the guidewire release slot.

[0011] Such a guidewire release slot may be configured to receive a guidewire extending outwardly from a proximal port of a guidewire lumen of the long shaft. The elongate housing may also optionally have a guidewire retention clip extending outwardly from an outer surface of the elongate housing and disposed proximal to the proximal end of the guidewire release slot.

[0012] Some embodiments of a vascular closure assembly may include an actuator assembly having: a chassis having a distal end and a proximal end; a plug capable of translating proximally relative to the chassis over a retracted length starting from a distal position; and a tensioner having a first end fixed to the chassis, a second end releasably fixed to the plug, and the tensioner configured to continuously apply a proximally directed tension to the plug relative to the chassis over the retracted length. The actuator assembly may also include a trigger latch capable of releasably fixing the plug in the distal position, opposite the tensioner; and a plate capable of translating distally from a proximal cocked position to a distal position relative to the plug over a deployed length, the distal position actuating the trigger latch and releasing the plug, thereby allowing the plug to translate proximally over the retracted length.

[0013] The actuator assembly may also include a compression spring having a first end operably connected to the plug, a second end operably connected to the plate, and the compression spring configured to apply a distally directed force to the plate from the proximal cocked position of the plate to the distal position of the plate over the deployed length. A plate latch may be operably connected to the base having a configuration that allows braking of the plate latch but prevents distal translation of the plate latch relative to the base. The plate latch may include a plate catch operably connected to the plate to releasably fix the plate in the proximal cocked position. An actuation button may be operably connected to the plate latch and configured to actuate the plate latch to disengage the plate catch from the plate.

[0014] The actuator assembly may also have an elongate housing and a plurality of anchor deployers, with the proximal end of the elongate housing fixed to the distal end of the chassis, and each anchor deployer slidably disposed within a respective anchor deployer lumen of the elongate housing. Each anchor deployer may include: a deployment rod having an elongate resilient structure operably connected to a plate such that distal translation of the plate causes distal translation of the deployment rod; and an anchor removably fixed to the distal end of the deployment rod.

[0015] Some embodiments of a method of actuating an actuator assembly of a vascular closure assembly may include actuating a platen latch of the actuator assembly with an actuation button operably connected to a base, thereby releasing a compression spring operably connected between a plug and the platen from a compressed state. Thereafter, under a distal force generated by the released compression spring, translate the platen and a deployment rod operably fixed to the platen in a distal direction relative to the plug and the base, and then actuate a trigger latch that releasably fixes the plug to the platen in a distal position when the platen translates distally, thereby releasing the plug from the fixed distal position. Finally, the method may include translating the plug, the platen, and the deployment rod fixed to the platen in a proximal direction under a proximal force generated by a tensioner fixed to the base and releasably fixed to the plug.

[0016] Some embodiments of a vascular closure assembly may include a base and an elongate housing having a proximal end fixed to the distal end of the base. A plurality of anchor deployers may be configured to extend from a distal section of the elongate housing, where each anchor deployer includes an anchor and a wire fixed to the anchor. The elongate housing may include: a wire lock assembly having a wire tube and a wire lock member having a lumen disposed over an outer surface of a distal section of the wire tube; and a guide wire member having a lumen disposed over the wire tube, axially adjacent to the wire lock member. A polymer load transfer bushing may also be disposed between a guide pulley and the wire lock member.

[0017] Certain embodiments are further described in the following description, examples, claims, and drawings. These features of the embodiments will become more apparent from the following detailed description in conjunction with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 A perspective view of an embodiment of a vascular closure assembly is shown, the vascular closure assembly embodiment including an actuator assembly having a chassis handle portion and an elongate housing extending therefrom and an inner catheter assembly locator disposed within a lumen of the actuator assembly.

[0019] Figure 2 An embodiment of a vascular closure assembly is shown having a locator rod of an inner catheter assembly in a deployed configuration Figure 1 of.

[0020] Figure 3 isFigure 1 Perspective view of a vascular closure assembly, where, for illustrative purposes, half of the outer shell of the chassis portion is not shown.

[0021] Figure 4 is Figure 1 Perspective view of the distal portion of the inner catheter assembly of the vascular closure assembly, where the inflatable balloon of the inner catheter assembly is shown in a deflated configuration and the foot extension of the inner catheter assembly is shown in a retracted configuration in a pre-deployed state.

[0022] Figure 4A is Figure 4 Front elevational schematic view of the distal segment of the inner catheter assembly.

[0023] Figure 5 is for the inner catheter assembly of the vascular closure assembly in an axially extended deployed state Figure 1 Perspective view of the distal portion of the inner catheter assembly of the vascular closure assembly, where the inflatable balloon of the inner catheter assembly is shown in an inflated state and the foot extension of the inner catheter assembly is shown in an axially deployed state.

[0024] Figure 5A is Figure 5 Front elevational schematic view of the distal segment of the inner catheter assembly.

[0025] Figure 6 is Figure 1 Perspective view of the distal portion of the inner catheter assembly of the vascular closure assembly, where the inflatable balloon is in a post-deployed state and where blood has been drained from the inflatable balloon.

[0026] Figure 7 Perspective view of an embodiment of a one-way valve of the inner catheter assembly shown in an open configuration.

[0027] Figure 8 is shown in a closed state Figure 7 Perspective view of an embodiment of the one-way valve.

[0028] Figure 9 Perspective view shown in a partial cross-section, showing the guide wire path in an elongate housing embodiment of the vascular closure assembly and the distal segment of the inner catheter assembly.

[0029] Figure 10 is Figure 1 Front view of a partial longitudinal section of the proximal segment of the chassis portion of the vascular closure assembly and the associated proximal portion of the inner catheter assembly, showing an embodiment of a stop latch of the inner catheter assembly.

[0030] Figure 11AA perspective view of a proximal section of a chassis in a longitudinal cross-section is shown, where an inner catheter assembly embodiment is engaged with a brake and spring embodiment that pushes an interlock to lock the inner catheter assembly embodiment in a fixed axial position relative to the chassis portion determinately.

[0031] Figure 11B is shown Figure 11A of the proximal section of the chassis, showing Figure 11A depressing of the interlock of the embodiment causes the inner catheter assembly embodiment to move out of the interlock position and translate axially relative to the chassis portion.

[0032] Figure 12 is Figure 1 A perspective view of a partial cross-section of the distal tip of an elongate housing embodiment of an actuator assembly of a vascular closure assembly of.

[0033] Figure 12A is Figure 12 An end view of a wire lock bushing embodiment of.

[0034] Figure 13 is Figure 1 A front view of a vascular closure assembly, where half of the outer shell of the chassis portion is not shown for illustrative purposes, and where the vascular closure assembly is set in a loaded configuration ready for deployment.

[0035] Figure 13A is a view showing Figure 13 An enlarged view of the engagement of a trigger latch embodiment and a plug embodiment of.

[0036] Figure 14 is Figure 13 A front view of a vascular closure assembly, where the vascular closure assembly is set in an initial deployment state where a deployment rod actuator compression spring is released, and where an anchor deployer (not shown) will be in a state of extending and deploying distally as shown in Figure 17 shown.

[0037] Figure 15 is Figure 14 A front view of a vascular closure assembly, where the vascular closure assembly is set in an initial wire retraction and withdrawal state of a deployment rod of an anchor deployer embodiment.

[0038] Figure 16 is Figure 15 A perspective view of a vascular closure assembly during use for secondary tensioning of a wire using a knob and threaded barrel engaged with a tubular plug, and where a deployment of a wire lock component (not shown) onto the wire using a wire lock assembly will also occur, as shown in Figure 19 shown.

[0039] Figure 17Perspective view of the distal segment of the elongate housing of the vascular closure assembly of the device embodiment during deployment of the deployment rod and the associated anchor of the anchor deployer.

[0040] Figure 18 Is Figure 17 Perspective view of the distal tip segment of the elongate housing of the actuator assembly after proximal retraction and withdrawal of the deployment rod of the anchor deployer after deployment is complete.

[0041] Figure 19 Is Figure 18 Perspective view of the wires, wire locks, and anchors of the vascular closure assembly after the wires have been properly tensioned and the wire locks have been deployed onto the wires.

[0042] Figure 20 Front view of an elongate housing embodiment shown for illustrative purposes without any additional structure of the vascular closure assembly.

[0043] Figure 21 Is along Figure 20 Of the line 21-21 taken Figure 20 Cross-section of the elongate housing embodiment.

[0044] Figure 21A Is Figure 21 Magnified cross-section of the wire retainer embodiment of the elongate housing embodiment.

[0045] Figure 22 Is Figure 20 Perspective view of the elongate housing embodiment with a plurality of deployment rods set therein in an extended deployment state, wherein the proximal ends of the deployment rods are shown fixed to a plate embodiment.

[0046] Figure 23 Is Figure 22 Perspective view of the plurality of deployment rods and the plate.

[0047] Figure 24 Is Figure 22 End view of the elongate housing embodiment, the deployment rods, and the plate.

[0048] Figure 25 Is Figure 24 End view of the deployment rods and the plate.

[0049] Figure 26 Is Figure 25 Top view of the cranial deployment rod embodiment, the deployment rod embodiment being in the plane of the paper.

[0050] Figure 27 Is Figure 25 Side view of the caudal deployment rod embodiment, one of the preformed distal segments of the preformed distal segment of the deployment rod embodiment being in the plane of the paper.

[0051] Figure 28 is a perspective view of an embodiment of a vascular closure assembly.

[0052] Figure 29 is Figure 28 a partial cross-sectional front view of an embodiment of the vascular closure assembly of

[0053] Figures 30 to 32 shows a schematic view of the tip of an elongate housing embodiment and a chassis embodiment of an embodiment of a vascular closure assembly, the elongate housing embodiment and the chassis embodiment of the embodiment of the vascular closure assembly being in partial cross-section during actuation / retraction of its wire tube embodiment and having a plurality of separation portions.

[0054] The drawings are intended to illustrate certain exemplary embodiments and not to limit. For clarity and ease of illustration, the drawings may not be to scale, and in some cases, aspects may be enlarged or magnified to facilitate understanding of a particular embodiment. Detailed Description

[0055] Embodiments of the devices discussed herein (which may include vascular closure devices or assemblies) may be used to percutaneously close access holes into body cavities such as arteries including the common femoral artery. Embodiments of the vascular closure assembly may work by using an extension wire (sometimes referred to herein as a deployment rod) to place a plurality of anchors (such as three, four, or more anchors) in a pattern circumferentially disposed around a channel in a tissue layer (such as a fascia layer), adjacent to the access hole in the blood vessel at the access location. A wire such as a suture or any other suitable wire embodiment may be connected or otherwise fixed to each anchor, wherein the wire extends from the respective anchor and enters the distal nasal end portion of the elongate housing of the device through the distal port of the wire tube at the distal end of the nasal tip of the elongate housing. The wire may then extend proximally through the lumen of the wire tube and may ultimately be directly or indirectly connected or otherwise fixed to a tensioner such as a spring or the like.

[0056] For some embodiments, during deployment, these wires may be tensioned proximally from their respective anchor positions at their distal ends to a common point such as the distal port of the wire tube. This tension thus pulls the tissue layer together to close the channel in the tissue layer and at the same time isolates and prevents blood leakage from the access hole in the patient's blood vessel. As described above, for some embodiments, the access hole in the patient's blood vessel may be disposed below and adjacent to the relevant channel in the tissue layer. A wire lock embodiment may then be deployed from the nasal tip of the elongate housing onto the wire, and the wire may then be cut by an internal mechanism in the base portion handle or by any other suitable mechanism.

[0057] Examples of similar systems and methods are discussed in the following documents: U.S. Patent 11,179,145, titled "Collapsible Tube for Hemostasis," filed by T. Larzon et al. on November 14, 2018; U.S. Patent Publication 2019 / 0142403, titled "Tissue Closure Device," filed by H. Nyman et al. on November 14, 2018; U.S. Patent 10,639,020, titled "Vascular Closure Device," filed by T. Larson et al. on September 27, 2016; U.S. Patent Publication 2020 / 0129164, titled "Self-Expanding Hemostatic Devices and Methods for Fascia and Vessel Passages," filed by T. Larzon et al. on October 23, 2019, and U.S. Patent Publication 2021 / 0145421, titled "Vascular Closure Devices and Methods," filed by B. Hauck et al. on November 18, 2020. Each of these documents is hereby incorporated by reference in its entirety. Any suitable features, dimensions, or materials of the embodiments of these incorporated references can be used in any suitable embodiments discussed herein.

[0058] In some cases, embodiments of the vascular closure assembly can include two main components consisting of an actuator assembly and a locator (also referred to herein as an inner catheter assembly). The actuator assembly can include a handle (also referred to herein as a chassis or chassis portion) and an elongate housing extending distally from the chassis. The inner catheter assembly can include a small lumen extending along its length to provide an indication that the distal end of the inner catheter assembly is within the lumen of a target blood vessel, such as an artery, which can include the common femoral artery. Embodiments of the inner catheter assembly can also include a foot extension for positioning against the anterior wall of the blood vessel from within the lumen of the blood vessel, and an inflatable balloon for maintaining hemostasis during the procedure (which can be inflated by the blood pressure within the artery). The elongate housing can extend from the chassis portion and can be used to at least partially house a plurality of anchor deployer embodiments (such as three, four, or more anchor deployers) and facilitate the deployment of the plurality of anchor deployers. In some cases, each anchor deployer can include an anchor to which a respective wire (such as a suture) is attached or otherwise secured.

[0059] For some embodiments of the deployment method, the anchor can be implanted at a position circumferentially disposed around a passage through a tissue layer (such as a fascia layer) that is adjacent to an access hole in a blood vessel. The deployment rod can be advanced distally or otherwise actuated by a release spring (such as a compression spring in some cases). In some cases, the compression spring can be released or otherwise deployed by a button on the chassis portion. An internal mechanism in the chassis portion can be used to control another spring (which can include a constant-force type tension spring in some cases) to automatically retract the deployment rod once the anchor has been advanced through the tissue layer. The constant-force spring can also be used to apply tension to the suture to close the passage in the tissue layer. Once the suture connection to the components of the base portion has been cut or otherwise disconnected, the suture lock embodiment can be deployed onto the tensioned suture to hold the suture in place and in a fixed relationship with each other.

[0060] Some embodiments of the vascular closure assembly can include good intuitive ergonomics for ease of use. Some such embodiments of the vascular closure assembly device can also include a reduced or otherwise low-profile nose / distal portion of the elongate housing that can be configured to allow direct insertion of the nose after sheath removal during the deployment procedure without the need for preparation of the tissue tract (such as manual dilation), such as the passage in the tissue layer, the access hole of the blood vessel in use, or the dermal tissue or any other relevant tissue disposed above the tissue layer. The low profile of the nose can also enable the entire closure procedure to be completed with the longitudinal axis of the elongate housing of the device set at an angle of approximately 45 degrees (natural guidewire entry angle) relative to the longitudinal axis of the patient's target blood vessel. Thus, during the deployment procedure, it may not be necessary to elevate or otherwise change the orientation of the vascular closure assembly device to change the angle of the device relative to the target blood vessel, thereby increasing the ease of use for the operator.

[0061] Some embodiments of the vascular closure assembly can include a preformed deployment rod to facilitate a desired distribution of the anchors around the passage in the tissue layer. Some such embodiments of the deployment rod can be constructed of an elastically shape-set material such as nitinol (including superelastic nitinol). This pre-bent geometry of the distal segment of the deployment rod can allow a desired pattern of anchor deployment around the passage while also maintaining the longitudinal axis of the vascular closure assembly at a natural 45-degree angle or any other suitable angle relative to the longitudinal axis of the target blood vessel. Some such embodiments can include two general types of deployment rods, depending on the circumferential position relative to the longitudinal axis of the nose of the elongate housing. In some cases, these two types of deployment rods can include a cephalic deployment rod and a caudal deployment rod.

[0062] For some embodiments, the cephalad deployment shaft may have an optimized geometry that is different from the geometry of the caudad deployment shaft, which may be naturally required by the angle of the handle or chassis portion relative to the patient's anatomy during deployment. In some cases, for some embodiments, these shaped deployment shafts and the nose tip configuration may allow the same device to be used on the patient's right groin or left groin.

[0063] For some embodiments of the vascular closure assemblies discussed herein, the deployment shaft may be spring-driven for deployment of the anchor and tissue penetration as described above. In some cases, spring-driven deployment may eliminate variability in anchor deployer performance due to different operator inputs, etc. For some device embodiments, deployment of the anchor may be accomplished by simply pressing an actuator button on the chassis of the device. In some cases, the actuator button may be located on the top of the chassis of the vascular closure assembly such that it can be conveniently reached from either side of the device, as some operators prefer contralateral deployment across the table while other operators prefer contralateral deployment from the other side of the table.

[0064] For some embodiments, a feature may include a single control for both foot extension actuation and balloon inflation valve actuation, which combines the two functions and thus simplifies user operation. A stop may be provided on the inner catheter assembly with a matching engagement feature on the chassis handle to make it easier for the operator to slide the chassis down the long axis of the inner catheter assembly to the correct relative axial position for deployment. The stop may also be arranged to guide the operator as to how far to retract the chassis relative to the inner catheter assembly after the wire has been tensioned. In some cases, this feature may eliminate the need for the operator to visually reference alignment marks on the inner catheter assembly when translating the chassis up or down along the inner catheter assembly during the deployment sequence.

[0065] For some embodiments of the vascular closure assembly, wire lock deployment may be performed with a wire tensioning knob rather than using a separate control on the chassis handle. For such embodiments, the operator may simply turn the tensioning knob a fixed number of turns (e.g., four) to tension the wire, then retract the inner catheter assembly, and then continue to turn the same tensioning knob until it stops, thereby deploying the wire lock. This may simplify the user's operation of the device in certain cases. An interlock may be integrated into the wire tensioning knob mechanism such that the wire tensioning knob stops after a fixed number of turns (e.g., four), so that the operator does not inadvertently turn the knob too far before retracting the inner catheter assembly.

[0066] At the distal end of the long axis of the inner catheter assembly, the guide wire can just leave the long axis behind or proximal to the nose cone of the inner catheter assembly ("quick exchange" type) and pass through the guide holes in the tabs on the rear side of the tip of the elongate housing. This configuration can significantly reduce the profile of the inner catheter assembly, which may be beneficial for reducing the overall outer profile of the tip through which the inner catheter assembly passes.

[0067] The operation of some of the device embodiments discussed herein for closing the access hole in a patient's blood vessel can begin when the endovascular procedure is complete and when the guide wire is set to pass through the access hole and within the patient's blood vessel lumen and the associated passageway through the tissue layer disposed over the blood vessel. The actuator assembly with the inner catheter assembly can first be loaded onto the guide wire and then advanced through the passageway and into the access hole (while maintaining hemostasis via manual compression) until visible blood return appears at the proximal end of the inner catheter assembly. Then the rod can be elevated or otherwise actuated to deploy the foot extension and allow inflation of the inflatable balloon, and the actuator assembly and the inner catheter assembly can be pulled in the proximal direction until the foot extension engages the inner surface of the anterior wall of the patient's blood vessel, which anterior wall is adjacent to the access hole in the blood vessel. The hemostatic inflatable balloon is quickly inflated and expands outwardly against the periphery of the access hole, thereby providing temporary bleeding control at the access site. Manual compression can then be released.

[0068] Then, the actuator assembly can be slid distally on the inner catheter assembly until it engages the stopper, thereby positioning the nose tip at the correct distance from the blood vessel (and the tissue layer above and adjacent to the blood vessel) at the end of the elongate housing. Next, the button on the chassis is pressed to deploy the anchor deployer and the associated anchor into the tissue layer and through the tissue layer, which tissue layer can include the fascia layer. Then the wire tension can be applied by rotating the large knob at the proximal end of the chassis. Then, the foot extension is retracted and the balloon inflation valve is closed by lowering the rod, and subsequently the inner catheter assembly is retracted proximally into the lumen of the elongate housing, thereby allowing the wire tension to fully close the access hole in the fascia layer. Finally, the wire lock is deployed by the wire lock assembly, by continued rotation of the suture tensioning knob until it stops, and the wire is cut by pulling on the tab / trigger at the bottom of the chassis. At this time, the entire blood vessel closure assembly can be slid proximally off the guide wire, the guide wire can be withdrawn from the patient's blood vessel, and the skin wound can be closed in a standard manner.

[0069] Some embodiments of the vascular closure assembly may include one or more or any combination of the following features. In some cases, the distal segment of the deployment rod may have a preset shape that enables a desired tissue layer penetration pattern and an entry angle relative to the longitudinal axis of the device's chassis and elongate housing, where the device's chassis and elongate housing are positioned at an angle of approximately 45 degrees relative to the axis of the patient's blood vessel. In some cases, a 45-degree deployment angle may represent a typical and natural angle for guidewire entry and related intervention device entry into the lumen of the patient's blood vessel. In some cases, a single-button activated mechanism may be used that uses stored energy (e.g., a compression spring) to advance the deployment rod a set distance in the forward distal direction into a tissue layer (such as a fascia layer). Thereafter, a plug may be deployed that allows a second spring to retract the deployment rod and / or apply tension to the wire without further input from the operator.

[0070] For some embodiments, a knob on the rear (proximal) portion of the chassis may be configured to allow slow, progressive tightening of the wire until a specified predetermined tension is reached, after which the wire tension is controlled by a constant force spring and further rotation of the knob does not affect the wire tension. For some embodiments, subsequent rotation of the knob deploys a wire lock. Stopping features on the chassis and inner catheter assembly may be configured to provide clear, unambiguous feedback to the operator when the components of the vascular closure assembly are in the correct position for deploying the anchor and subsequently when the inner catheter assembly is fully retracted prior to wire lock deployment. In some cases, a single rod on the proximal end of the long axis of the inner catheter assembly may be configured to actuate a foot extension and simultaneously actuate a balloon inflation valve that allows hemodynamic pressure to fill an inflatable balloon. A simple rod-actuated wire cutter may be configured to allow the operator to easily cut the wire prior to withdrawing the vascular closure assembly from the patient.

[0071] For some embodiments, the anchor configuration and wire-anchor connection may be the same as or similar to those discussed in U.S. Patent Publication No. 2021 / 0145421, titled “Vascular Closure Device and Method,” filed by B. Hauck et al. on Nov. 18, 2020, the entire disclosure of which is incorporated herein by reference. Additionally, the wire lock embodiments discussed herein may be the same as or similar to those discussed in that same disclosure. Some embodiments of the vascular closure assembly may also include one or more or any combination of the following features. For example, during deployment, instead of 4 rotations, stop and remove the inner catheter assembly and then complete rotation of the knob to stop - complete all rotations to stop in one sequence and remove the inner catheter assembly after all rotations. In some cases, for such embodiments, twisting the knob does not deploy the wire lock. In some cases, the wire cutting rod may be configured to deploy the wire lock and cut the wire, thereby allowing removal of the base.

[0072] Reference Figures 1 to 6 shows an embodiment of the actuator assembly 9 and the associated inner catheter assembly 10 of the vascular closure assembly embodiment 8. The inner catheter assembly 10 can be an elongated cylindrical device that passes completely through the chassis 42 and the elongate housing 44 of the actuator assembly 9. The inner catheter assembly 10 can also have a large circular hub 11 and a rod 13 and a thin tube at the proximal end of the chassis 42, such as a long axis 46 having an inflatable balloon 15, a foot extension 14, a balloon inflation valve 48, and a guide wire tracking distal segment nose cone 24. The main device deployment button 12 is located on top of the chassis 42 to facilitate left- and right-handed operation by the operator using either the right or left hand. Figure 2 shows the locator rod 13 in the deployed state, and this deploys the foot extension 14 inside the inflatable balloon 15 located on the distal aspect of the inner catheter assembly 10. The rod 13 is also configured to open the balloon inflation valve 48 distal to the foot extension 14, which allows blood to enter and fill the inflatable balloon 15 to provide hemostasis during the procedure.

[0073] Figure 3 is a cross-sectional view of an embodiment through the chassis 42, where the locator rod 13 is lifted, which causes the foot extension 14 to be deployed. The rod 13 can be operably connected to an actuation wire 50, the distal segment of which is shown in Figures 4 to 6 in combination with the structure and function of the balloon inflation valve 48. The actuation wire 50 can be configured to actuate the foot extension 14 and translate the two plugs 20, 21 together with the one-way valve 16. Figure 4 and Figure 4A shows an embodiment of the distal end 24 of the inner catheter assembly 10 in the pre-deployed state, where the locator rod 13 is in the non-pulled state as shown in Figure 1 . The inflatable balloon 15 is deflated, and the plugs 20, 21 and the one-way valve 16 are positioned to allow blood to enter the blood return hole 18 and flow proximally through the inner catheter assembly 10 as shown by the arrow 49, to provide an indication to the operator of the distal end 52 of the inner catheter assembly 10 within the lumen of the patient's blood vessel, and also indicate that the foot extension 14 can be deployed. There are two holes 17a, 17b in the flexible lumen of the long axis 46 within the inflatable balloon 15. There is an additional hole 19 distal to the inflatable balloon 15, which allows the inflatable balloon 15 to expand when the locator rod 13 is lifted / actuated, resulting in the plugs 20, 21 and the foot extension 14 being translated proximally to the filling position, as shown in Figure 5 and Figure 5A .

[0074] Figure 5 and Figure 5A shows an embodiment of the distal end 24 of the inner catheter assembly 10 in the deployed state, where the locator rod 13 is actuated / lifted, as shown in Figure 2 and Figure 3As shown. The foot extension 14 is deployed, and the distal plug 20 and the proximal plug 21 have been translated across two holes 17a, 17b within the inflatable balloon 15 respectively to positions proximal to those holes 17a, 17b. With the inner catheter assembly 10 in the deployed state, blood can enter the distal hole 19 as shown by arrow 51 and flow through the lumen via the internal holes 17a, 17b and fill the inflatable balloon 15. Since the proximal plug 21 blocks the flow path, it prevents blood from flowing out of the inflatable balloon 15 and flowing downward along the blood return lumen.

[0075] Figure 6 An embodiment 10 of an inner catheter assembly with a retracted foot extension 14 is shown after deployment has been performed. The plugs 20, 21 have been translated back across the internal holes 17a, 17b respectively to positions distal to the holes 17a, 17b, as Figure 4 and Figure 4A shown. Since the distal plug 20 blocks the flow entering through the distal hole 19, arterial blood or any other pressurized fluid source within the blood vessel no longer fills the inflatable balloon 15. During Figure 5 and Figure 5A the actuation state shown, the blood contained within the inflatable balloon 15 can now leave through the proximal hole 17b, flow through the one-way valve 16, and exit from the blood return lumen. This configuration can be configured to achieve the feature that once blood flows into the inflatable balloon 15, it never returns to the patient's blood vessel, thus eliminating any potential risk of thrombosis caused by the stagnant blood in the inflatable balloon 15 returning to the patient's body.

[0076] Figure 7 and Figure 8 show an embodiment 16 of a one-way valve, where the baffle 23 is in the open position and the closed position respectively. Figure 7 The baffle 23 is shown in the open position away from the proximal sealing surface 23a, where the flow channel 16a is open to allow blood to flow through the baffle 23 in the proximal direction. Figure 8 The baffle 23 is shown pressed against the proximal sealing surface 23a, where the flow channel 16a is closed, thus preventing blood from flowing distally through the flow channel 16a. Figure 9A cross-section of a device embodiment is shown, where the nose cone 24 includes a "quick-change" configuration, in which the guide wire 57 enters the distal end port 54 of the nose cone 24 and exits the proximal end of the nose cone 24 at the proximal port 53 that is distal to the inflatable balloon 15, and bypasses the remainder of the device until it reaches the alignment hole 25 provided within the guide wire clip 22. By passing the guide wire 57 through the alignment hole 25, the possibility that the deployment rod 39 and the anchor 28 are deployed on opposite sides of the guide wire 57 (thereby trapping it), which would cause the inner catheter assembly 10 to be unable to be removed from the patient without first removing the guide wire 57, is eliminated. In some cases, the alignment hole 25 may include a slotted lumen that is configured to releasably hold the guide wire 57 therein under normal lateral loads, but allows the guide wire 57 to pass in and out through its lateral slots when the user applies a lateral load greater than the nominal lateral load. For such an embodiment, a snap-fit can be achieved.

[0077] Figure 10 Notches or pawls 25a in the long axis 46 of the inner catheter assembly embodiment 10 are shown. These notches 25a can be provided only on one side of the long axis 46 of the inner catheter assembly 10 and can be configured to provide a definite stop when axially sliding the chassis 42 along the long axis 46 of the inner catheter assembly 10 and when removing the inner catheter assembly embodiment 10 from the artery with the knob 56 in the vertical position and the spring-loaded pawl tab 58 facing upward. Figure 11A The action of the pawl interlock 60 to define the position of the inner catheter assembly 10 relative to the chassis 42 is shown. The spring forces the interlock 60 upward into the notch of the inner catheter assembly 10. Figure 11B Pressing the pawl interlock 58 (against the spring) to disengage the interlock 60 to allow the inner catheter assembly 10 to move to its next position is shown. It should be noted that since the notch 25a is provided only on one side of the long axis 46 and the stop tab 58 is also on one side of the knob, the notch 25a and the stop tab 58 must be rotationally aligned in order for the stop interlock 60 to function. Thus, if the knob 56 rotates away from the proper rotational alignment by a suitable amount, such as 180 degrees, as shown in Figure 11A and Figure 11B the long axis 46 and the stops 25a thereon will be able to freely translate within the knob 56 and the stop interlock 60.

[0078] Figure 12Illustrates the tip embodiment of the elongate housing embodiment 44. The tip contains a guidewire sleeve 26, a wire lock 27, two components including the wire lock, an anchor 28 (at four positions), and a wire tube 29. Four anchors 28 are attached to four wires 40. These wires 40 can be fed through the wire tube 29 and then attached to a constant force spring 34 in some cases using a simple quick disconnect such as a tension transfer clip 34a. The wire lock 27 can be engaged to the wire 40 by retracting the wire tube 29 from the wire lock 27 and allowing the wire lock shanks to be spring loaded inwardly to grip the wire 40. Due to the presence of a check surface 62 for the wire lock 27, they are configured to translate axially along the wire tube 29 when they are pulled back in the proximal direction against the check.

[0079] Further with respect to embodiments of the elongate housing and referring to Figures 1 to 6 , 12, 20, and 21, some embodiments of the vascular closure assembly 8 can include an inner catheter assembly 10 that includes a long axis 46 having a proximal end, a distal end 52, a distal segment, an axial length, and a guidewire lumen 55. For some embodiments, the guidewire lumen extends proximally from a distal port 54 at the distal end 52 of the long axis 46 to a proximal port 53 disposed in the distal segment, as Figure 9 shown. The vascular closure assembly 8 can also include an actuator assembly 9 having a chassis portion 42 and a plurality of anchor deployers 68, each anchor deployer 68 including a deployment rod 39, an anchor 28 that can be removably fixed to the distal end of the deployment rod 39, and a wire 40 fixed to each anchor 28. The elongate housing 44 of the actuator assembly 9 can have a proximal end fixed to the distal end of the chassis portion 42 and includes a distal end 45 and a lumen 43 that extends along the elongate housing 44 to the distal end 45 of the elongate housing 44. The lumen 43 can include an inner surface profile that is configured to slidably receive the outer surface of the long axis 46 of the inner catheter assembly 10.

[0080] The elongate housing embodiment 44 may also include a plurality of anchor deployer lumens 74 configured to be slidably disposed about respective anchor deployers 68, each anchor deployer lumen 74 extending axially along the elongate housing 44, or along any other suitable path of the elongate housing 44, and terminating distally at a distal port 76 disposed in the distal segment 72 of the elongate housing 44. Some embodiments of the elongate housing 44 may also include a guidewire release slot 47 disposed within the lumen 43 through a wall portion of the lumen 43, the guidewire release slot 47 extending proximally from the distal end 106 of the lumen 43 to the proximal end 108 of the guidewire release slot 47, and the guidewire release slot 47 being configured to receive a guidewire extending outwardly from the proximal port 53 of the guidewire lumen 55 of the long axis 46. Additionally, in some instances, a guidewire retention clip 22 extending outwardly from the elongate housing 44 may be disposed proximal to the proximal end 108 of the guidewire release slot 47.

[0081] Some embodiments of a vascular closure assembly 8 may include an actuator assembly 9 having a chassis portion 42 and a plurality of anchor deployers 68, each anchor deployer 68 including a deployment rod 39, an anchor 28 removably fixable to the distal end of the deployment rod 39, and a filament 40 secured to each anchor 28. The actuator assembly 9 of such embodiments may also include an elongate housing 44 having a proximal end fixed to the distal end of the chassis portion 42, a distal end 45, and a lumen 43 extending along the elongate housing 44 to the distal end 45 of the elongate housing 44. The elongate housing may also include a plurality of anchor deployer lumens 74 configured to be slidably disposed about respective anchor deployers 68, each anchor deployer lumen 74 extending axially along the elongate housing 44, or along any other suitable path of the elongate housing 44, and terminating distally at a distal port 76. The elongate housing may also include a plurality of filament retainers 110 disposed proximal to the distal port 76 of the anchor deployer lumen 74, each filament retainer 110 being configured to releasably secure a portion of a respective filament 40. In some instances, each filament retainer 110 may include a split tube configuration, which may include a tubular structure having a split portion 112 in its wall structure, the split portion 112 extending completely through the wall of the tubular structure and along the entire axial length of the tubular structure.

[0082] For such a wire retainer embodiment 110, if made of a flexible and elastic material, having a lumen 114 disposed around a corresponding wire 40 and a separation portion 112 extending along the axial length of the separation tube 110, the wire 40 disposed within the lumen 114 can be releasably fixed therein during the deployment and positioning of the vascular closure assembly 8 under normal use and tissue interaction, and the wire 40 is released under the loads associated with the deployment of the anchor deployer 68 and subsequent tensioning of the wire 40. For some embodiments, the separation tube of some wire retainer embodiments 110 can include a polymer having a hardness range such as from about 20 Shore D hardness to about 80 Shore D hardness. In some cases, the elongate housing 44 can also include a plurality of anchor recesses 116. The anchor recesses 116 can be disposed adjacent corresponding distal ports 76 of the anchor deployer lumen 74 and are configured to receive the corresponding anchors 28 such that the sharp distal ends of the anchors 28 are allowed to be disposed below the nominal outer surface profile of the distal section of the elongate housing 44 when the anchor deployer 68 is in the undeployed state.

[0083] Some vascular closure assembly embodiments 8 can include a base 42, an elongate housing 44, and a plurality of anchor deployers 68, with the proximal end of the elongate housing 44 fixed to the distal end of the base 42, and each anchor deployer 68 including an anchor 28 and a wire 40 fixed to the anchor 28. The vascular closure assembly 8 can also include a wire locking assembly 70, the wire locking assembly 70 including a wire tube 29 and one or more wire locks 27. The wire lock 27 can include a lumen disposed on the outer surface of the distal section of the wire tube 29. The wire locking assembly 70 can also include a guide sleeve 26 having a lumen disposed on the wire tube 29 and axially disposed near and distal to the wire lock 27. Such an embodiment can also include a polymer bushing 66 disposed between the guide sleeve 26 and the adjacent wire lock 27. In some cases, the polymer bushing 66 can include a polymer such as nylon, polyimide, etc. Such a polymer bushing 66 can be configured to prevent ohmic contact and possible electrolysis between the wire lock 27 and the axially adjacent guide sleeve 26, and in some cases, the guide sleeve 26 can be made of a metal material different from that of the wire lock 27.

[0084] Figure 13A cross-sectional view of chassis embodiment 42 in a to-be-launched position is shown, where chassis embodiment 42 is ready for deployment. The plate catcher 30a of the plate latch 30 secures the deployment rod plate 32. When the plate latch trigger 30 is pressed or otherwise actuated, the deployment rod plate 32 can be driven forward by a compression spring 33. A tensioner that may include a constant force spring 34 is operably connected to the plug 35 via a tension transfer clip 34a. The plug 35 is held in the loaded position by the trigger latch lever 31. When the deployment rod plate 32 is driven forward by the compression spring 33, the deployment rod 39 attached with the anchor 28 is driven through the fascial tissue layer 64, as Figure 17 shown. For some embodiments, when the deployment rod plate 32 reaches the end of its stroke, it pushes the latch lever 31 upward and disengages it from the plug 35, allowing the plug 35 to be pulled back by the constant force spring 34 until the plug 35 engages the hand-tightening screw 36.

[0085] Some vascular closure assembly embodiments 8 may include an actuator assembly 9, and the actuator assembly 9 may include a chassis 42 having a distal end and a proximal end. The plug 35 may translate proximally relative to the chassis 42 over a retraction length starting from a distal position of the plug 35, as Figure 13 shown. The tensioner 34 has a first end fixed to the chassis 42, a second end releasably fixed to the plug 35 using a tension transfer clip 34a, and is configured to continuously apply a proximally oriented tension to the plug 35 relative to the chassis 42 over the retraction length of the deployment rod 39 and the wire 40. The trigger latch 31 may be configured to releasably fix the plug 35 in the distal position contrary to the proximal force applied to the plug 35 by the tensioner 34. The plate 32 may be translatable distally relative to the plug 35, from a proximal cocked position through a deployment length to a distal position that actuates the trigger latch 31 and releases the plug 35, thereby allowing the plug 35 to translate proximally over the retraction length.

[0086] The compression spring 33 has a first end operably connected to the plug 35 and a second end operably connected to the plate 32. The compression spring 33 may be configured to apply a distally directed force to the plate 32 from the proximal cocked position of the plate 32 to the distal position of the plate 32 over the deployment length. In some cases, when the compression spring 33 is actuated or released, the plate 32 translates with a restricted linear motion relative to the plug 35. The plate latch 30 is operably connected to the chassis 42, and its configuration allows actuation of the plate latch 30 but prevents the plate latch 30 from translating distally relative to the chassis 42. The plate latch 30 may include a plate catcher 30a, and the plate catcher 30a is operably connected to the plate 32 and releasably fixes the plate 32 in the proximal cocked position. The actuation or deployment button 12 may be operably connected to the plate latch 30 and is configured to actuate the plate latch 30 to disengage the plate catcher 30a from the plate 32.

[0087] The actuator assembly 9 may also include an elongate housing 44 having a proximal end thereof secured to the distal end of the chassis 42 and including a plurality of anchor deployers 68. Each anchor deployer 68 may be slidably disposed within a respective anchor deployer lumen 74 of the elongate housing 44. In some instances, each anchor deployer 68 may include a deployment rod 39 having an elongate resilient configuration, the deployment rod 39 being operably connected to the plate 32 such that distal translation of the plate 32 causes distal translation of the deployment rod 39. In some instances, the anchor 28 may be removably secured to the distal end of the deployment rod 39. In some instances, the plug 35 may include a tubular configuration that is constrained to translate proximally in a linear axial direction relative to the chassis 42 from a distal position of the plug 35. In some instances, the plate 32 may be disposed within the lumen of the tubular plug 35 and may translate axially within the lumen of the tubular plug 35. For some embodiments, the proximal segment of the plug 35 may include a threaded barrel segment.

[0088] For some embodiments, the trigger latch 31 may include a pivot configuration having a proximal end 118 pivotally connected to the chassis 42 and a distal end including a distally facing engagement surface 120 that engages a proximally facing latch surface 122 of the plug 35. For some embodiments, the tensioner 34 may include a constant tension spring, such as a wound ribbon clock spring or the like. For some embodiments, the compression spring 33 may include a helically wound cylindrical or conical spring.

[0089] For such an actuator assembly embodiment 9, a method of actuating an actuator assembly 9 may include actuating a platen latch 30 of the actuator assembly 9 with an actuation button 12 operably connected to the base 42, thereby releasing a compression spring 33 operably connected between the plug 35 and the plate 32 from a compressed state of the compression spring 33. Thereafter, under a distal force generated by the released compression spring 33, the plate 32 and associated deployment rod 39 operably secured thereto are axially translated in a distal direction relative to the plug 35 and the base 42. Then, as the plate 32 is translated distally, the trigger latch 31 may be actuated with the plate 32, thereby subsequently releasing the plug 35 from a fixed distal position. Thereafter, the method may include axially translating the plug, the plate, and the deployment rod secured to the plate in a proximal direction under a proximal force generated by the tensioner 34, the tensioner being secured to the chassis 42 and releasably secured to the plug 35 using a tension transfer clip 34a.

[0090] Figure 14Shows an initial portion of an anchor deployment embodiment, where the platen latch 30 has been depressed, which causes the compression spring 33 to force the deployment lever plate 32 distally, which releases the latch lever 31. As the deployment lever plate 32 moves distally, since the anchors 28 are attached to the ends of the deployment rods 39, the deployment lever plate 32 can be configured to drive the four anchors 28 distally to a position beneath the tissue layer 64, as Figure 17 shown. Figure 15 Shows a cross-sectional view of the second part of the deployment sequence. After the latch lever 31 has been lifted by the deployment lever plate 32, the plug 35 slides proximally until the plug 35 engages the hand-tightening screw 36. During this sequence, as the deployment lever plate 32 slides proximally, it can be configured to withdraw the deployment rod 39 from the tissue layer 64, leaving the anchors 28 (connected to the wire) beneath the tissue layer 64.

[0091] Figure 16 Shows the next step in the deployment sequence embodiment. Once the plug 35 engages the hand-tightening screw 36, the hand-tightening screw 36 can be rotated, which enables the plug 35 to continue retracting in a controlled manner. The wire 40 is attached to the constant force spring 34 by the tension transfer clip 34a. Once the tension in the wire 40 balances with the constant force spring 34, the tension transfer clip 34a and the associated tensioner 34 disengage from the plug 35. As the plug 35 retracts by further rotation of the hand-tightening screw 36, at a specified distance, the end of the wire tube 29 is engaged, causing the wire tube 29 to retract (move proximally) from the wire lock 27, thereby allowing the wire lock 27 to engage the wire 40, as Figure 19 shown. Finally, by actuating Figures 14 to 16 the wire cutter 38 shown, the wire 40 is cut, disconnecting the wire 40 from the constant force spring 34. The wire cutter 38 is configured to be actuated individually by pulling the rod of the wire cutter 38 extending downward from the chassis 42 backward. Pulling the rod of the wire cutter 38 backward pivots the wire cutter blade (not shown) upward and into the adjacent tensioned wire 40 (not shown), thereby cutting them and allowing the withdrawal of the vascular closure assembly 8.

[0092] For some vascular closure assembly embodiments 8, by the operator actuating / retracting the wire tube 29, the deployment of the wire lock 27 and subsequent cutting of the wire 40 can be performed sequentially in one action. Figures 30 to 32 Shows a schematic view of the nose end of the elongate housing 44 and the chassis 42 in partial cross-section and having a plurality of separation portions, which shows an embodiment for performing such a process. Figure 30The wire tube 29 is shown in the most distal position, where the wire lock 27, the wire sleeve 26, and the bushing 66 are disposed on the distal portion of the wire tube 29 within the elongate housing 44. The engagement axial length 126 of the distal portion of the wire tube 29 with the wire lock 27, the wire sleeve 26, and the bushing 66 is represented by the bracket 126. The engagement axial length 126 represents the proximal retraction amount of the wire tube 29 required to fully deploy the wire lock 27, the wire sleeve 26, and the bushing 66 from the wire tube 29.

[0093] Figure 30 An intermediate portion of the wire tube 29 is also shown, which includes an elongate channel 128 passing through the wall portion of the wire tube 29. The distal end of the elongate channel 128 includes a first cutting edge 130. The intermediate portion of the wire tube 29 passes through the inner cavity 133 of the cutting block 132, which has a second cutting edge 134 disposed at its distal end. The cutting block 132, the inner cavity 133, and the associated first cutting edge 130 can be in any suitable form, such as a tubular member with a sharp distal end. In some cases, the outer surface of the wire tube 29, the inner surface of the inner cavity 133, and the first cutting edge 130 and the second cutting edge 134 can be configured to produce a shearing cutting function when the wire tube 29 is retracted proximally as shown by the arrow 136, such that the first cutting edge 130 and the second cutting edge 134 come together and ultimately pass by each other. Figure 30 The axial spacing between the shown first cutting edge 130 and the second cutting edge 134 (where the wire tube 29 is in the most distal position) can be referred to as the cutting stroke length indicated by the bracket 137. In order to achieve proper sequential deployment of the wire anchor 27 and subsequent cutting of the wire 40, it may be crucial in some cases that the cutting stroke length 137 is greater than the engagement axial length 126.

[0094] Figure 30 A schematic view of the proximal portion of the base 42 is also shown, which shows an embodiment of the connection between the wire tube 29 of the inner catheter assembly 10 and the long axis 46. The embodiment of the connection includes a tension block 138 fixed to the long axis 46 and having an inner cavity 140, which is configured to be slidably disposed on the outer surface of the nominal section of the wire tube 29. A tab 142 is fixed to the wire tube 29 proximal to the tension block 138 and has a transverse dimension that is too large to pass through the inner cavity 140, such that when the operator retracts the long axis 46 and the associated tension block 138 proximally, the wire tube 29 will slide within the cavity 140 of the tension block 138 until the tab 142 of the wire tube 29 contacts the tension block 138. Thereafter, further proximal retraction of the long axis 46 and the tension block 138 as shown by the arrow 136 will apply a proximal retraction force to the tab 142 and the wire tube 29.

[0095] Figure 31 Shows the proximal retraction of the long axis 46 on Figure 30The wire tube embodiment 29 shown has the effect of proximal retraction. Figure 31 In the embodiment, the wire tube 29 has been retracted proximally so that the distal section and distal end of the wire tube 29 have been completely retracted from the wire lock 27, the wire sleeve 26 and the bushing 66, thereby fully deploying these components onto the suture 40, as shown. The proximal retraction of the wire tube 29 also brings the first cutting edge 130 into close proximity with the second cutting edge 134, wherein the wire 40 passes through the lumen of the wire tube 29 to a position located within the chassis 42 but outside the lumen of the wire tube 29. Therefore, in Figure 31 In the embodiment shown in FIG. 1 , the proximal end of the wire 40 has been completely retracted from the inner cavity of the wire tube 29 and has been cut by the cutting edges 130 , 134 . Figure 31 Shown in Figure 30 The intermediate cross-section of the wire tube 29 and the cutting block 132 after the wire tube 29 is further retracted proximally after the relative position shown. Figure 31 , the wire lock 27, the wire sleeve 26 and the wire bushing 66 have been fully deployed, and the first cutting edge 130 and the second cutting edge 134 are ready to cut the wire 40 when the wire tube 29 is further retracted proximally.

[0096] Figure 17 The distal end of the nose tip of the elongated housing embodiment 44 is shown with the deployment rods 39 extending distally and the anchors 28 attached to the ends of these deployment rods 39. Figure 17 Also shown is the wire 40 attached to the anchor 28 and how the wire 40 is fed upwardly through the centrally located wire tube 29 . Figure 18 Anchor 28 is shown deployed. Tissue layer 64 and the passage therethrough are not shown, but anchor 28 would be engaged beneath tissue layer 64, and anchor 28 may define a passage therearound. Figure 19 The implant, a component of the device, is shown remaining in the patient's body. The wire lock 27 is in a deployed state, wherein the locking tabs spring inward onto the wire 40, thereby engaging the four wires 28 to clamp them together, thereby avoiding relative movement between the clamping portions of the four wires 40 and the locking tabs and preventing them from loosening. The four anchors 28 attached to the wires 40 will be tightened, thereby causing a gathering of the tissue layer 64 (not shown) placed above the passage, which causes the access hole in the artery to be blocked.

[0097] As described above, some embodiments of the vascular closure assembly 8 can include an anchor deployer 68 that includes a deployment rod 39 having a preformed or curved configuration that, in some instances, can have a smooth continuous curvature. Some such embodiments of the vascular closure assembly 8 can include an actuator assembly 9 having a chassis portion 42 and an elongate housing 44, the proximal end of the elongate housing 44 being fixed to the distal end of the chassis portion 42, the distal end extending away from the chassis portion 42, the distal section 72 can include a nose end, and a plurality of anchor deployer lumens 74. In some instances, each anchor deployer lumen 74 can extend axially along the elongate housing 44 and terminate distally in a distal port 76 disposed in the distal section 72 of the elongate housing 44.

[0098] A plurality of anchor deployers 68 can each be slidably disposed within a respective anchor deployer lumen 74 of the elongate housing 44. Each anchor deployer 68 can include a deployment rod 39 that includes an elongate resilient configuration and a preformed distal section 78 that presents a curved profile when in a relaxed state and a straightened profile when in a constrained state within the respective anchor deployer lumen 74 and is configured to extend along a curved path from the respective distal port 76 when its extension is relaxed and presents a curved profile. Each of the anchor deployers 68 further includes an anchor 28 that is removably fixed to the distal end of the deployment rod 39, where some anchor embodiments are configured to resist proximal retraction within tissue. A wire 40 can be fixed to each anchor 28. For some such embodiments, the preformed distal section 78 can have a preformed profile that lies in a plane (without compound curvature).

[0099] For some embodiments, the preformed distal section 78 of each deployment rod 39 is configured to extend distally from its respective distal port 76 until the distal end of the deployment rod 39 is disposed at a tissue penetration angle at a tissue penetration location, where the distal end of the elongate housing 44 is disposed near the tissue layer 64 and where the longitudinal axis of the elongate housing 44 is set at an angled deployment angle relative to the tissue layer 64. For some embodiments, the elongate housing 44 and the preformed distal section 78 of each deployment rod 39 are configured to cause the deployment rod 39 to extend at a tissue penetration angle and engage the tissue layer 64, where the elongate housing 44 is set at a deployment angle of about 40 degrees to about 50 degrees relative to the patient.

[0100] In some instances, the deployment rods 39 of the plurality of anchor deployers 68 can include at least two cephalad deployment rods 82 whose distal ends extend away from the distal section 72 of the elongate housing 44 and laterally away from each other, as Figure 26As shown. The plurality of anchor deployers 68 may also include at least two caudal deployment rods 84 that extend away from and below the distal segment of the elongate housing 44 and extend below the cranial deployment rods 82. In some cases, when in the extended deployment state, the preformed distal segments 78 of at least two cranial deployment rods 82 lie in the same plane 86, as Figure 24 and Figure 25 shown, forming a relative angle 104 of about 180 degrees therebetween, but which can also be from about 160 degrees to about 200 degrees. For some embodiments, the preformed distal segments 78 of at least two caudal deployment rods 84 lie in respective planes that are set at an angle 88 of from about 70 degrees to about 125 degrees, more specifically from about 70 degrees to about 110 degrees, with respect to each other, as Figure 24 shown. For some embodiments, the relative angle 102 between the plane of the preformed distal segment 78 of the cranial deployment rod 82 and the plane of the preformed distal segment 78 of an adjacent caudal deployment rod 84 can be from about 30 degrees to about 75 degrees, more specifically from about 30 degrees to about 55 degrees. In some cases, as Figure 26 shown, the radius of curvature 90 of the preformed distal segment 78 of the cranial deployment rod 82 can be from about 22 mm to about 30 mm. For some such embodiments, as Figure 27 shown, the radius of curvature 92 of the preformed distal segment 78 of the caudal deployment rod 84 can be from about 12 mm to about 18 mm.

[0101] For some embodiments, the deployment rod 39 can be configured to translate axially relative to the elongate housing 44, but be fixed against rotation about its respective longitudinal axis 92. Figure 22 Four deployment rods 39 are shown, with their respective proximal ends fixed to the plate 32 such that rotation of the deployment rods 39 about their longitudinal axes 92 relative to the plate 32, the chassis 42, and the elongate housing 44 is prevented. Figures 22 to 27 The deployment rod embodiment 39 shown includes an anchor engagement portion 94 that extends proximally from the distal end of the deployment rod 39 and is angled in a direction opposite to the direction of the curved profile of the preformed distal portion 78. In some cases, the anchor engagement portion 94 of each deployment rod 39 extends proximally from the distal end of the deployment rod 39 a distance of at most about 0.5 to about 1.5 times the axial length of the anchor 28. For some embodiments, the anchor engagement section 94 of each deployment rod 39 is angled 96 in a direction opposite to the curved profile of the preformed distal segment 78, from about 16 degrees to about 22 degrees.

[0102] For some embodiments, the preformed distal segment 78 of the cranial deployment rod 82 is configured to have a nominal distal end angle 98 (without the anchor engagement segment 94) relative to the longitudinal axis 92 of the deployment rod 39, from about 80 degrees to about 90 degrees; the deployment rod 39 is disposed proximal to the preformed distal segment 78, and the preformed distal segment 78 is disposed as Figure 26in the shown relaxed and unconstrained state. In some cases, the pre-bent distal segment 78 of the caudal deployment rod 84 is configured to have a nominal distal end angle 100 (without the anchor engagement section 94) relative to the longitudinal axis 92 of the deployment rod 39, from about 110 degrees to about 130 degrees; the deployment rod 39 is disposed proximal to the preformed distal segment 78, and the preformed distal segment 78 is disposed as Figure 27 in the shown relaxed and unconstrained state. In some cases, the preformed distal segment 78 of the cranial deployment rod 82 can be configured to have a lateral displacement of about 20 mm to about 30 mm from the longitudinal axis 92 of the deployment rod 39 perpendicular to the distal end of the deployment rod 39 when the preformed distal segment 78 of the deployment rod 39 is in a relaxed and unconstrained state. Additionally, the preformed distal segment 78 of the caudal deployment rod 84 can be configured to have a lateral displacement of about 20 mm to about 30 mm from the longitudinal axis 92 of the deployment rod 39 perpendicular to the distal end of the deployment rod 39 when the preformed distal segment 78 of the deployment rod 39 is in a relaxed and unconstrained state.

[0103] Figure 28 and Figure 29 illustrates an embodiment of the vascular closure assembly 8, which may have features, dimensions, or materials that are the same as or similar to those of the above-described vascular closure assembly embodiment 8. The actuator assembly 9 of the illustrated embodiment may include an actuator button 12 and an associated trigger latch 31, which releasably constrains the plate 32 as described above. The actuator assembly 9 further includes a deployment button cover 124, which is configured to slide relative to the chassis 42 and mechanically capture the actuator button 12 to prevent accidental actuation of the assembly. To ready the actuator assembly 9, the deployment button cover 124 can be slid distally to release the actuator button 12 to allow its movement and actuation.

[0104] The embodiments illustratively described herein may suitably be practiced in the absence of any element not specifically disclosed herein. Thus, for example, in each instance herein, any one of the terms "comprising", "consisting essentially of", and "consisting of" may be replaced with any one of the other two terms. The terms and expressions that have been employed are used as descriptive terms and not as restrictive terms, and the use of such terms and expressions does not exclude any equivalents of the features shown and described or portions thereof, and various modifications are possible. The term "a" or "an" can refer to one or more of the elements it modifies (e.g., "a reagent" can mean one or more reagents), unless the context clearly describes one of the elements or more than one of the elements.

[0105] Accordingly, it should be understood that although embodiments have been specifically disclosed by way of representative embodiments and alternative features, those skilled in the art may adopt modifications and variations of the concepts disclosed herein, and such modifications and variations are considered to be within the scope of this disclosure.

[0106] Regarding the foregoing detailed description, like reference numerals used therein refer to the same elements that may have the same or similar dimensions, materials, and configurations. Although particular forms of the embodiments have been shown and described, it will be apparent that various modifications may be made without departing from the spirit and scope of the embodiments of the present invention. Accordingly, it is not intended that the present invention be limited to the foregoing detailed description.

Claims

1. A vascular closure assembly, comprising: An actuator assembly, comprising: A chassis portion; An elongate housing having a proximal end fixed to a distal end of the chassis portion, a distal end extending away from the chassis portion, a distal section, and a plurality of anchor deployer lumens, each of the anchor deployer lumens extending along the elongate housing and terminating distally at a distal port disposed in the distal section of the elongate housing; and A plurality of anchor deployers, each of the anchor deployers slidably disposed within a corresponding one of the anchor deployer lumens of the elongate housing, each of the anchor deployers comprising: A deployment rod having an elongate elastic configuration and a preformed distal section that presents a curved profile when in a relaxed state and a Straightened profile when in a constrained state within the corresponding one of the anchor deployer lumens, and configured to extend along a curved path from the corresponding distal port when its extended portion is relaxed and presents a curved profile, An anchor removably fixed to the distal end of the deployment rod and configured to resist proximal retraction within tissue; and A filament fixed to each anchor.

2. The vascular closure assembly according to claim 1, wherein, The preformed distal section of each deployment rod is configured to extend distally from the corresponding distal port until the distal end of the deployment rod is disposed at a tissue penetration location at a tissue penetration angle, wherein the distal end of the elongate housing is disposed adjacent to a tissue layer, and wherein the longitudinal axis of the elongate housing is disposed at an angled deployment angle relative to the tissue layer.

3. The vascular closure assembly according to claim 2, wherein, The elongate housing and the preformed distal section of each deployment rod of the elongate housing are configured to extend the deployment rod and engage the tissue layer at a tissue penetration angle, wherein the elongate housing is disposed at a deployment angle of about 40 degrees to about 50 degrees relative to the patient.

4. The vascular closure assembly according to claim 1, wherein, The preformed distal sections of the respective deployment rods lie in a plane.

5. The vascular closure assembly according to claim 1, wherein, The deployment rods of the plurality of anchor deployers include at least two cephalad deployment rods and at least two caudal deployment rods, the distal ends of the at least two cephalad deployment rods extending laterally away from the distal section of the elongate housing and away from each other, and the at least two caudal deployment rods extending away from the distal section of the elongate housing and below the cephalad deployment rods.

6. The vascular closure assembly according to claim 5, wherein, When in a deployed state, the preformed distal sections of the at least two cephalad deployment rods lie in the same plane.

7. The vascular closure assembly according to claim 5, wherein, The preformed distal sections of the at least two caudal deployment rods lie in respective planes that are angled relative to each other by about 70 degrees to about 110 degrees.

8. The vascular closure assembly according to claim 5, wherein, The radius of curvature of the preformed distal section of the cephalad deployment rod is about 22 mm to about 30 mm.

9. The vascular closure assembly according to claim 5, wherein, The radius of curvature of the preformed distal section of the caudal deployment rod is about 12 mm to about 18 mm.

10. The vascular closure device according to claim 1, wherein, The deployment rods are configured to translate relative to the elongate housing but are fixed against rotation about their respective longitudinal axes.

11. The vascular closure assembly according to claim 1, wherein, Each of the deployment rods includes an anchor engagement section that extends proximally from the distal end of the deployment rod and is angled in a direction opposite to the direction of the curved profile of the preformed distal section.

12. The vascular closure assembly according to claim 11, wherein, The anchor engagement section of each deployment rod extends proximally from the distal end of the deployment rod by a distance that is at most about 0.5 to about 1.5 times the axial length of the anchor.

13. The vascular closure assembly according to claim 11, wherein, The anchor engagement section of each said deployment rod forms an opposite angle of about 16 degrees to about 22 degrees with the curved profile of the preformed distal section.

14. The vascular closure assembly according to claim 5, wherein, The preformed distal section of the cephalic deployment rod is configured to have a nominal distal end angle of about 80 degrees to about 90 degrees (without the anchor engagement section) relative to the longitudinal axis of the deployment rod, the longitudinal axis of the deployment rod being proximal to the preformed distal section, and the preformed distal section being in a relaxed and unconstrained state.

15. The vascular closure assembly according to claim 5, wherein, The pre-bent distal section of the caudal deployment rod is configured to have a nominal distal end angle of about 110 degrees to about 130 degrees (without the anchor engagement section) relative to the longitudinal axis of the deployment rod, the longitudinal axis of the deployment rod being proximal to the preformed distal section, and the preformed distal section being in a relaxed and unconstrained state.

16. The vascular closure assembly according to claim 5, wherein, The preformed distal section of the cephalic deployment rod is configured to have a lateral displacement of about 20 mm to about 30 mm of the distal end of the deployment rod from the longitudinal axis of the deployment rod perpendicular to the distal end when the preformed distal section of the deployment rod is in a relaxed and unconstrained state.

17. The vascular closure assembly according to claim 5, wherein, The preformed distal section of the caudal deployment rod is configured to have a lateral displacement of about 20 mm to about 30 mm of the distal end of the deployment rod from the longitudinal axis of the deployment rod perpendicular to the distal end when the preformed distal section of the deployment rod is in a relaxed and unconstrained state.

18. The vascular closure assembly according to claim 1, wherein, The preformed distal section of each said deployment rod has a smooth and continuous curvature.

19. A vascular closure assembly, comprising an actuator assembly, the actuator assembly including: A chassis portion; A plurality of anchor deployers, each anchor deployer including a deployment rod, an anchor removably fixed to the distal end of the deployment rod, and a wire fixed to each anchor; And An elongate housing, which includes A proximal end fixed to the distal end of the chassis portion, A distal end, An inner lumen extending along the elongate housing to the distal end of the elongate housing, A plurality of anchor deployer lumens configured to be slidably disposed around respective anchor deployers, each anchor deployer lumen extending along the elongate housing and terminating distally at a distal port disposed in the distal section of the elongate housing, and A plurality of wire retainers disposed proximal to the distal ports of the anchor deployer lumens, each wire retainer being configured to releasably fix a portion of a corresponding wire.

20. The vascular closure assembly according to claim 19, wherein, Each said wire retainer includes a separating tube made of a flexible and elastic material, the separating tube having an inner lumen disposed around the respective wire and a separating portion extending along the axial length of the separating tube.

21. The vascular closure assembly according to claim 20, wherein, The separating tube includes a polymer.

22. The vascular closure device according to claim 19, wherein, The elongate housing further includes a plurality of anchor recesses, each of which is disposed adjacent a respective distal port of the anchor deployer lumen and is configured to receive a respective anchor such that, when the anchor deployer is in an undeployed state, a sharp distal end of the anchor is permitted to be disposed below a nominal outer surface profile of the distal section of the elongate housing.

23. A vascular closure assembly, comprising: An inner catheter assembly including a long axis having a proximal end, a distal end, a distal section, an axial length, and a guidewire lumen that extends proximally from a distal port at the distal end of the long axis to a proximal port disposed at the distal section; And An actuator assembly including: A chassis portion; A plurality of anchor deployers including a deployment rod, an anchor removably fixed to a distal end of the deployment rod, and a wire fixed to each of the anchors; and An elongate housing including A proximal end fixed to a distal end of the chassis portion, A distal end, An inner lumen that extends along the elongate housing to the distal end of the elongate housing, the inner lumen having an inner surface profile configured to slidably disposed over an outer surface of the long axis, A plurality of anchor deployer lumens configured to slidably disposed around respective anchor deployers, Each of the anchor deployer lumens extending along the elongate housing and terminating distally at a distal port disposed in the Distal section of the elongate housing, and A guidewire release slot disposed in the inner lumen through a wall portion thereof, the guidewire release slot extending proximally from a distal end of the inner lumen to a proximal end of the guidewire release slot and being configured to receive a guidewire extending outwardly from a proximal port of the guidewire lumen of the long axis.

24. The vascular closure assembly according to claim 23, further comprising a guidewire retention clip that extends outwardly from the elongate housing and is disposed proximal to a proximal end of the guidewire release slot.

25. A vascular closure assembly, comprising: An actuator assembly including: A base having a distal end and a proximal end, A plug that is translatable proximally relative to the base over a retracted length starting from a distal position, A tensioner having a first end fixed to the chassis, a second end releasably fixed to the plug, and being configured to continuously apply a proximally directed tension to the plug relative to the chassis over the retracted length, A trigger latch that releasably fixes the plug in the distal position, opposite the tensioner, A plate that is translatable distally relative to the plug, from a proximal cocked position over a deployed length to a distal position that actuates the trigger latch and releases the plug, allowing the plug to translate proximally over the retracted length, A compression spring having a first end operatively connected to the plug, a second end operatively connected to the plate, and being configured to apply a distally directed force to the plate from the proximal cocked position of the plate to the distal position of the plate over the deployed length, A plate latch, which is operably connected to the base, has a configuration that allows the plate latch to be actuated but prevents the plate latch from translating distally relative to the base. The plate latch includes a plate catch, which is operably connected to the plate, thereby releasably fixing the plate in a proximal cocked position, and an actuation button, which is operably connected to the plate latch and is configured to actuate the plate latch to disengage the plate catch from the plate; an elongate housing, the proximal end of which is fixed to the distal end of the base; and a plurality of anchor deployers, each of the anchor deployers being slidably disposed within a respective anchor deployer lumen of the elongate housing, and each of the anchor deployers including a deployment rod, which has an elongate resilient configuration, the deployment rod being operably connected to the plate such that distal translation of the plate causes distal translation of the deployment rod, and an anchor, which is removably fixed to the distal end of the deployment rod.

26. The vascular closure assembly according to claim 25, wherein, The plug includes a tubular configuration that is restricted from translating proximally in the axial direction from the distal position of the plug, and the plate is disposed within the lumen of the tubular plug and is capable of translating within the lumen of the tubular plug.

27. The vascular closure assembly according to claim 26, wherein, The proximal section of the plug includes a threaded cylinder.

28. The vascular closure assembly according to claim 25, wherein, The trigger latch includes a pivot configuration having a proximal end pivotally connected to the chassis and a distal end including a distally facing engagement surface that engages a proximally facing latch surface of the plug.

29. The vascular closure assembly according to claim 25, wherein, The tensioner includes a constant tension spring.

30. The vascular closure assembly according to claim 25, wherein, The compression spring includes a helically wound cylindrical spring.

31. A method of actuating an actuator assembly of a vascular closure assembly, comprising actuating a plate latch of the actuator assembly using an actuation button operably connected to a chassis, thereby releasing a compression spring operably connected between a plug and a plate from a compressed state; translating the plate and a deployment rod operably fixed thereto relative to the plug and the base in a distal direction under a distal force generated by the released compression spring; actuating a trigger latch that, when the plate translates distally, releasably fixes the plug together with the plate in a distal position, thereby releasing the plug from a fixed distal position; translating the plug, the plate, and the deployment rod fixed to a platen in a proximal direction under a proximal force generated by a tensioner fixed to the base and releasably fixed to the plug.

32. A vascular closure assembly, comprising a base; an elongate housing having a proximal end fixed to the distal end of the base; a plurality of anchor deployers configured to extend from a distal section of the elongate housing, each of the anchor deployers including an anchor and a wire fixed to the anchor; a wire lock assembly, which includes a wire tube, a wire lock member having a lumen disposed over an outer surface of a distal section of the wire tube, a guide wire member having a lumen disposed over the wire tube and axially adjacent to the wire lock member, and a polymer bushing disposed between the guide wire member and the wire lock member.

33. The vascular closure assembly according to claim 32, wherein, The polymer bushing includes a polymer.

34. The vascular closure assembly according to claim 33, wherein, The polymer includes polyimide.

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