Vascular closure devices and methods

Abstract

A vascular closure assembly may include an actuator assembly having a chassis portion and an elongated housing, the elongated housing having a proximal end fixed to the distal end of the chassis portion, a distal end extending away from the chassis portion, a distal portion, and a plurality of anchor expander lumens. Each anchor expander lumen may extend axially along the elongated housing or in any other suitable path and terminate distally at a distal port located within the distal portion of the elongated housing. The actuator assembly may further include a plurality of anchor expanders, each anchor expander may be slidably positioned within the respective anchor expander lumen of the elongated housing. Each anchor expander may include an expanding rod having an elongated elastic configuration and a pre-formed distal portion that takes on a curved outer shape when relaxed.

Description

Technical Field

[0001] (Related Application) This application claims the benefit of priority from U.S. Provisional Patent Application No. 63 / 420,391, filed on October 28, 2022, by B. Hauck et al. and entitled "Large Bore Closure Devices and Methods", which is incorporated herein by reference in its entirety.

Background Art

[0002] In many percutaneous procedures, a catheter is inserted into an access hole in a blood vessel such as the femoral artery. Such percutaneous procedures can include minimally invasive cardiovascular procedures including, for example, balloon angioplasty procedures, atherectomy procedures, cardiovascular stent deployment, heart valve replacement, stent graft deployment, and others. During such procedures, a therapeutic catheter can typically be inserted directly into the artery by a guidewire or the catheter can be inserted through a vascular introducer sheath. When the therapeutic procedure is complete, the physician generally removes the therapeutic catheter and then removes the introducer sheath from the blood vessel (if it was used). 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 several methods to close the vascular access hole or otherwise limit post-procedure bleeding from the access hole (local external compression, suture-mediated closure devices, open direct suture-mediated, plugs, gels, foams, and similar materials, etc.).

[0003] However, such closure procedures are time-consuming and can consume a significant portion of the procedure's duration. In addition, some existing methods are associated with complications such as hematoma or thrombosis. Furthermore, some of these procedures, particularly suture-mediated closure devices, are known to have high failure rates in the presence of common vascular diseases such as atherosclerosis and calcification. What is needed are methods and devices that can be used to efficiently and conveniently close vascular access openings after the procedure is completed. [Overview of the project] [Means for solving the problem]

[0004] Some embodiments of a vascular closure assembly may include an actuator assembly having a chassis portion and an elongated housing, the elongated housing having a proximal end fixed to the distal end of the chassis portion, a distal end extending away from the chassis portion, a distal portion, and a plurality of anchor expander lumens. Each anchor expander lumen may extend axially along the elongated housing or in any other suitable path and terminate distally at a distal port located within the distal portion of the elongated housing. The actuator assembly may further include a plurality of anchor expanders, each anchor expander may be slidably positioned within the respective anchor expander lumen of the elongated housing. Each anchor expander may include an expanding rod having an elongated elastic configuration and a pre-formed distal portion that takes on a curved outer shape when relaxed. The pre-formed distal portions may have a linear outline while constrained within the respective anchor expander lumen, and may also be configured to extend from each distal port of the anchor expander lumen along a curved path, such that the extensions of the pre-formed distal portions relax and take on a curved outline. The anchor expander may also include anchors that may be removablely fixed to the distal end of the expansion rod and may be configured to resist proximal retraction within the tissue. Each filament may be fixed to each anchor of the anchor expander.

[0005] Some embodiments of a vascular closure assembly have an actuator assembly comprising a chassis portion and a plurality of anchor expanders, each of which may include an expander rod, an anchor removably fixed to the distal end of the expander rod, and filaments fixed to each anchor. The actuator assembly may further include an elongated housing having a proximal end fixed to the distal end of the chassis portion, a distal end, and an inner lumen extending along the elongated housing to the distal end of the elongated housing. The actuator assembly also includes a plurality of anchor expander lumens configured to be slidably positioned around each anchor expander, each anchor expander lumen extending along the elongated housing and terminating distally at a distal port located within the distal portion of the elongated housing. A plurality of filament holders may be positioned on the outer surface of the elongated housing proximal to the distal ports of the anchor expander lumens. In some cases, each filament holder may be configured to removably fix a portion of its respective filament.

[0006] Some embodiments of a vascular occlusion assembly may include an internal catheter assembly having an elongated shaft, the elongated shaft having a proximal end, a distal end, a distal portion, an axial length, and a guidewire lumen extending proximal from a distal port at the distal end of the elongated shaft to a proximal port located in the distal portion. The vascular occlusion assembly also includes an actuator assembly having a chassis portion and a plurality of anchor deployers, each anchor deployer may include a deploying rod, an anchor removably fixed to the distal end of the deploying rod, and a filament fixed to each anchor. The actuator assembly may also have an elongated housing, the elongated housing having a proximal end fixed to the distal end of the chassis portion, a distal end, and an internal lumen extending along the elongated housing to the distal end of the elongated housing, the internal lumen having an internal surface contour configured to be slidably positioned on the outer surface of the elongated shaft. The elongated housing further includes a plurality of anchor expander lumens, each configured to be slidably positioned around its respective anchor expander, with each anchor expander lumen extending along the elongated housing and potentially terminating distally at a distal port located within the distal portion of the elongated housing. The elongated housing may include a guidewire relief slot, which is located within the inner lumen through the wall portion of the elongated housing and extends proximal from the distal end of the inner lumen to the proximal end of the guidewire relief slot. Such a guidewire relief slot may be configured to accommodate a guidewire extending outward from the proximal port of the guidewire lumen of the elongated shaft. The elongated housing may optionally also have a guidewire retaining clip extending outward from the outer surface of the elongated housing and located proximal to the proximal end of the guidewire relief slot.

[0007] Some embodiments of a vascular occlusion assembly may include an actuator assembly comprising a chassis with distal and proximal ends, a plunger that is movable proximal to the chassis over a retinal length starting from the distal position, and a tensioner, the tensioner having a first end fixed to the chassis and a second end releasably fixed to the plunger, and configured to continuously apply tension to the plunger proximal to the chassis over the retinal length. The actuator assembly may also include a trigger latch that releasably fixes the plunger at the distal position opposite to the tensioner, and a platen that is movable distal to the plunger from a proximal cocked position over the extended length to the distal position, the distal position actinguating the trigger latch, releasing the plunger, and allowing proximal translation of the plunger over the retinal length. The actuator assembly may also include a compression spring having a first end operably coupled to a plunger and a second end operably coupled to a platen, and configured to apply a distally directed force to the platen from the proximal cocked position of the platen to the distal position of the platen over its extended length. A platen latch may be operably coupled to the chassis, and the platen latch may be configured to allow the platen latch to actuate but to prevent distal parallel movement of the platen latch relative to the chassis. The platen latch may include a platen catch operably coupled to the platen to fix the platen in a releasably positioned location in the proximal cocked position. An actuation button may be operably coupled to the platen latch and configured to actuate the platen latch to disengage the platen catch from the platen. The actuator assembly is an elongated housing, the elongated housing having a proximal end fixed to the distal end of a chassis, and also having a plurality of anchor deployers, each anchor deployer being slidably positioned within the respective anchor deployer lumen of the elongated housing. Each anchor deployer is a deploying rod having an elongated elastic configuration, the elongated elastic configuration may include a deploying rod operably coupled to a platen such that distal translation of the platen results in distal translation of the deploying rod, and an anchor detachably fixed to the distal end of the deploying rod.

[0008] Some embodiments of a method for operating an actuator assembly of a vascular closure assembly may include using an actuation button operably coupled to the chassis to actuate a platen latch of the actuator assembly, thereby releasing an operably coupled compression spring between the plunger and the platen from a compressed state. Subsequently, under the distal force generated by the released compression spring, the platen and the deployment rod operably fixed to it are moved distally relative to the plunger and chassis, and then the platen is used to actuate a trigger latch that releasably fixes the plunger in a distal position, thereby releasing the plunger from its fixed distal position, so that the plunger moves distally. Finally, the method may include moving the plunger, the platen, and the deployment rod fixed to the platen proximally under a proximal force generated by a tensioner fixed to the chassis and releasably fixed to the plunger.

[0009] Some embodiments of the vascular closure assembly may include a chassis and an elongated housing having a proximal end fixed to the distal end of the chassis. Multiple anchor expanders may be configured to extend from the distal portion of the elongated housing, and each anchor expander may include an anchor and a filament fixed to the anchor. The elongated housing may include a filament lock assembly, which comprises a filament tube and a filament lock having an inner lumen, the inner lumen being positioned to cover the outer surface of the distal portion of the filament tube, and a fairlead having an inner lumen positioned to cover the filament tube axially adjacent to the filament lock. A polymer load transfer bushing may be further positioned between the fairlead and the filament lock.

[0010] Certain embodiments are described further in the following description, examples, claims, and drawings. These features of the embodiments will become more apparent from the following detailed description when considered in conjunction with the accompanying exemplary drawings. [Brief explanation of the drawing]

[0011] [Figure 1] Figure 1 shows a perspective view of an embodiment of a vascular closure assembly that includes a chassis handle portion and an elongated housing extending therefrom, and an actuator assembly that includes an internal catheter assembly positioner positioned within the internal lumen of the actuator assembly.

[0012] [Figure 2] Figure 2 shows an embodiment of the vascular closure assembly of Figure 1 in which the positioner lever embodiment of the internal catheter assembly is in an unfolded configuration.

[0013] [Figure 3] Figure 3 is a perspective view of the vascular closure assembly of Figure 1, in which half of the outer shell of the chassis portion is not shown for illustrative purposes.

[0014] [Figure 4] Figure 4 is a perspective view of the distal portion of the medial catheter assembly of the vascular occlusion assembly of Figure 1, showing the inflatable balloon of the medial catheter assembly in a deflated configuration and the foot extension of the medial catheter assembly in a retracted configuration in a pre-deployment state.

[0015] [Figure 4A] Figure 4A is a schematic elevation view of the distal portion of the internal catheter assembly shown in Figure 4.

[0016] [Figure 5] Figure 5 is a perspective view of the distal portion of the medial catheter assembly of the vascular occlusion assembly of Figure 1, showing the inflatable balloon of the medial catheter assembly in the inflated state and the foot extension of the medial catheter assembly in the axially extended and unfolded state.

[0017] [Figure 5A] Figure 5A is a schematic elevation view of the distal portion of the internal catheter assembly shown in Figure 5.

[0018] [Figure 6] Figure 6 is a perspective view of the distal portion of the inner catheter assembly of the vascular occlusion assembly of FIG. 1, where the expandable balloon is in the deployed state and blood is being discharged out of the expandable balloon.

[0019] [Figure 7] Figure 7 is a perspective view of a one-way valve embodiment of the inner catheter assembly shown in the open configuration.

[0020] [Figure 8] Figure 8 is a perspective view of the one-way valve embodiment of FIG. 7 shown in the closed state.

[0021] [Figure 9] Figure 9 is a perspective view in a partial cross-section illustrating the guide wire path designation in an elongated housing embodiment of the vascular occlusion assembly and the distal portion of the inner catheter assembly.

[0022] [Figure 10] Figure 10 is an elevation view in a partial longitudinal cross-section of the proximal portion of the chassis portion of the vascular occlusion assembly of FIG. 1 and the associated proximal portion of the inner catheter assembly, illustrating a detent latch embodiment of the inner catheter assembly.

[0023] [Figure 11A] Figure 11A shows a perspective view of the proximal portion of the chassis in a longitudinal cross-section where an inner catheter assembly embodiment is engaged with a detent and spring embodiment, pushing an interlock to determinately lock the inner catheter assembly embodiment in a fixed axial location relative to the chassis portion.

[0024] [Figure 11B]Figure 11B shows the proximal portion of the chassis in Figure 11A, illustrating the depressing of the interlock in the embodiment of Figure 11A, which allows the internal catheter assembly embodiment to move outward from its mutual locking position and to move axially parallel to the chassis portion.

[0025] [Figure 12] Figure 12 is a perspective view of a partial cross-section of the distal nose tip of an elongated housing embodiment of the actuator assembly of the vascular closure assembly shown in Figure 1.

[0026] [Figure 12A] Figure 12A is an end view of the filament lock bushing embodiment shown in Figure 12.

[0027] [Figure 13] Figure 13 is an elevation view of the vascular closure assembly of Figure 1, in which half of the outer shell of the chassis portion is not shown for illustrative purposes, and the vascular closure assembly is positioned in a loaded configuration ready for deployment.

[0028] [Figure 13A] Figure 13A is an enlarged view showing the engagement of the trigger latch embodiment and plunger embodiment shown in Figure 13.

[0029] [Figure 14] Figure 14 is an elevation view of the vascular occlusion assembly of Figure 13, in which the vascular occlusion assembly is positioned in its initial deployed state, the deployment rod actuator compression spring is released, and the anchor deployer (not shown) is extended distally as shown in Figure 17 and positioned in the deployed state.

[0030] [Figure 15] Figure 15 is an elevation view of the vascular closure assembly of Figure 14, in which the vascular closure assembly is positioned in the initial filament retraction and withdrawal state of the unfolding rod of the anchor unfolder embodiment.

[0031] [Figure 16] Figure 16 is a perspective view of the vascular occlusion assembly of Figure 15 during secondary tensioning of the filament, using a knob and threaded barrel that engage with a tubular plunger. Deployment of a filament lock (not shown) onto the filament using a filament lock assembly would also occur, as shown in Figure 19.

[0032] [Figure 17] Figure 17 is a perspective view of the distal portion of the elongated housing of the vascular occlusion assembly during deployment of the deployment rod and associated anchor of the anchor deployer of the device embodiment.

[0033] [Figure 18] Figure 18 is a perspective view of the distal nose tip of the elongated housing of the actuator assembly shown in Figure 17 after the proximal retraction and extension of the deployment rod of the anchor deployer after deployment.

[0034] [Figure 19] Figure 19 is a perspective view of the filament, filament lock, and anchor of the vascular closure assembly from Figure 18 after the filament has been properly tensioned and the filament lock has been deployed on the filament.

[0035] [Figure 20] Figure 20 is an elevation view of an elongated housing embodiment of a vascular closure assembly shown for illustrative purposes, without any additional structures.

[0036] [Figure 21] Figure 21 is a cross-section of the elongated housing embodiment of Figure 20 obtained along line 21-21 in Figure 20.

[0037] [Figure 21A] Figure 21A is an enlarged cross-sectional view of the filament holder embodiment of the elongated housing embodiment shown in Figure 21.

[0038] [Figure 22]Figure 22 is a perspective view of the elongated housing embodiment of Figure 20, in which multiple deployment rods are arranged within it in an extended and deployed state, and the proximal ends of the indicated deployment rods are fixed to the platen embodiment.

[0039] [Figure 23] Figure 23 is a perspective view of the multiple deployment rods and platen shown in Figure 22.

[0040] [Figure 24] Figure 24 is an end view of the elongated housing embodiment, deployment rod, and platen shown in Figure 22.

[0041] [Figure 25] Figure 25 is an end view of the deployment rod and platen shown in Figure 24.

[0042] [Figure 26] Figure 26 is a top view of the head-side deployment rod embodiment of Figure 25, which is located in the plane of the page.

[0043] [Figure 27] Figure 27 is a side view of the caudal deployment rod embodiment of Figure 25, in which one of its pre-formed distal portions lies in the plane of the page.

[0044] [Figure 28] Figure 28 is a perspective view of an embodiment of a vascular closure assembly.

[0045] [Figure 29] Figure 29 is an elevation view in a partial cross-section of the vascular closure assembly embodiment shown in Figure 28.

[0046] [Figure 30] Figures 30-32 show schematic representations of the nose tip of elongated housing and chassis embodiments of a vascular closure assembly embodiment with multiple separation points between the operation and retraction of the filament tube embodiment in partial cross-section. [Figure 31]Figures 30-32 show schematic representations of the nose tip of elongated housing and chassis embodiments of a vascular closure assembly embodiment with multiple separation points between the operation and retraction of the filament tube embodiment in partial cross-section. [Figure 32] Figures 30-32 show schematic representations of the nose tip of elongated housing and chassis embodiments of a vascular closure assembly embodiment with multiple separation points between the operation and retraction of the filament tube embodiment in partial cross-section. [Modes for carrying out the invention]

[0047] The drawings are intended to illustrate, and not limit, an exemplary embodiment. For clarity and ease of illustration, the drawings may not be made to scale, and in some cases, various aspects may be exaggerated or enlarged to facilitate understanding of a particular embodiment.

[0048] Embodiments of devices, which may include vascular closure devices or assemblies discussed herein, may be used for percutaneous closure of access openings in body lumens, such as arteries, including the common femoral artery. Embodiments of vascular closure assemblies may function by using an extension wire (sometimes referred to herein as an unfolding rod) to position multiple anchors, such as three, four, or more, through tissue layers, such as the fascial layer, in a pattern circumferentially arranged around a passage in a tissue layer adjacent to the access opening in the vessel at the access site. Filaments, such as sutures or any other suitable filament embodiment, may be connected to or otherwise fixed to each anchor, and the filaments may extend from each anchor and enter the distal nose tip portion of the elongated housing of the device through the distal port of the filament tube at the distal end of the nose tip of the elongated housing. The filaments may then extend proximal through the inner lumen of this filament tube and may ultimately be connected to or otherwise fixed directly or indirectly to a tensioner, such as a spring.

[0049] In some embodiments, during deployment, these filaments can be tensioned proximal to a common point, such as the distal port of the filament tube, from their respective anchoring positions at their distal ends. Such tension thereby pulls the tissue layers together, closing the passage in the tissue layers and simultaneously isolating and preventing blood leakage from the access opening in the patient's blood vessel. As mentioned above, in some embodiments, the access opening in the patient's blood vessel may be located below and adjacent to the associated passage in the tissue layers. The filament locking embodiment can then be deployed onto the filament from the nose tip of the elongated housing, and the filament can then be cut by an internal mechanism in the chassis portion handle or by any other suitable mechanism.

[0050] Embodiments of similar systems and methods are described in U.S. Patent No. 11,179,145, filed November 14, 2018 by T. Larzon et al. and titled "Collapsible Tube for Hemostasis," U.S. Patent Publication No. 2019 / 0142403, filed November 14, 2018 by H. Nyman et al. and titled "Tissue Closure Device," U.S. Patent No. 10,639,020, filed September 27, 2016 by T. Larzon et al. and titled "Vascular Closure Device," U.S. Patent Publication No. 2020 / 0129164, filed October 23, 2019 by T. Larzon et al. and titled "Self-Expanding Hemostatic Devices and Methods for Fascia and Vessel Passages," and B. Hauck et al. This is discussed in U.S. Patent Publication No. 2021 / 0145421, filed by al. on November 18, 2020, and titled “Vascular Closure Devices and Methods” (each of which is incorporated herein by reference as a whole). Any suitable features, dimensions, or materials of the embodiments in these incorporated references may be used in any of the suitable embodiments discussed herein.

[0051] In some cases, an embodiment of a vascular occlusion assembly may include two main components: an actuator assembly and, as herein referred to, a positioner (also referred to as an internal catheter assembly). The actuator assembly may include, as herein referred to, a handle (also referred to as a chassis or chassis portion) and an elongated housing extending distally from the chassis. The internal catheter assembly may include a small lumen extending to its length to indicate that the distal end of the internal catheter assembly is positioned within the lumen of a target vessel, such as an artery, which may include the common femoral artery. An embodiment of the internal catheter assembly may also include a foot extension for positioning against the anterior wall of the vessel from within the internal lumen of the vessel, and an inflatable balloon (which may be inflated by blood pressure from within the artery) for maintaining hemostasis during the procedure. The elongated housing may extend from the chassis portion and may be used to at least partially house and facilitate the deployment of multiple (three, four, or more) anchor deployer embodiments, such as anchor deployers. In some cases, each anchor deployer includes an anchor, and each filament, such as a suture, can be attached to the anchor or otherwise secured.

[0052] In some deployment method embodiments, the anchor may be embedded by a deployment rod at a location circumferentially positioned around a passage through a tissue layer, such as a fascial layer, adjacent to an access opening in a blood vessel. The deployment rod may be advanced distally by the release of a spring, such as a compression spring, or otherwise actuated. The compression spring may be released by a button on a chassis portion, or otherwise deployed. An internal mechanism within the chassis portion may be used to control another spring (which may include a constant-force tension spring in some cases) to automatically retract the deployment rod once the anchor has advanced through the tissue layer. This constant-force spring may be used to apply tension to the filament and close the passage in the tissue layer. A filament locking embodiment may be deployed on the tensioned filament to hold the filament in place and in a fixed relationship with respect to each other when the filament connection to the chassis portion component is cut or otherwise disconnected.

[0053] Some embodiments of vascular occlusion assemblies may include good intuitive ergonomics for ease of use. Some embodiments of such vascular occlusion assembly devices may also include a low-profile or otherwise thin-profile nose tip / distal portion of the elongated housing, which may be configured to allow direct insertion of the nose tip during sheath removal in the deployment procedure without any requirement for preparation (e.g., manual dilation) of tissue tubes such as passages in the tissue layer, access openings in the vessel being used, or dermal tissue or any other associated tissue located above the tissue layer. The thin profile of the nose tip may also allow the entire occlusion procedure to be performed with the longitudinal axis of the device's elongated housing positioned at an angle of approximately 45 degrees (natural guidewire entry angle) with respect to the longitudinal axis of the patient's target vessel. Thus, there is no need to raise (or otherwise modify) the orientation of the vascular occlusion assembly device to alter the angle of the device relative to the target vessel during the deployment procedure, and thus ease of use for the operator can be increased.

[0054] Some embodiments of vascular occlusion assemblies may include a pre-formed deployment rod to facilitate the desired distribution of anchors around the passage in the tissue layer. Some such deployment rod embodiments may be constructed from resilient shaping materials such as nitinol, including superelastic nitinol. Such a pre-curved geometric shape of the distal portion of the deployment rod allows for a desired anchor deployment pattern around the passage, while also maintaining the longitudinal axis of the vascular occlusion assembly at a natural 45-degree angle or any other suitable angle with respect to the longitudinal axis of the targeted vessel. Some such embodiments may include two general types of deployment rods, depending on the circumferential position of the nose tip of the elongated housing with respect to the longitudinal axis. In some cases, the two types of deployment rods may include a cranial deployment rod and a caudal deployment rod. With respect to some embodiments, the cranial deployment rod may have an optimized geometric shape different from that of the caudal deployment rod, as this may be naturally required by the angle of the handle or chassis portion relative to the anatomical structure of the patient during deployment. These molded deployment rods, along with the nose tip configuration, may in some cases allow the same device to be used over either the right or left inguinal region of the patient for several embodiments.

[0055] With respect to some of the vascular occlusion assembly embodiments discussed herein, the deployment rod may be spring-driven for anchor deployment and tissue penetration as discussed above. Spring-driven deployment may, in some cases, eliminate variability in anchor deployer performance due to various operator inputs, etc. With respect to some device embodiments, anchor deployment may be performed by simply pressing down 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 occlusion assembly, thereby making it conveniently accessible from both sides of the device, as some operators prefer to reach across the table for deployment on the opposite side, while others prefer to work from the opposite side of the table for deployment on the opposite side.

[0056] In some embodiments, a feature may be included that includes a single control device for the operation of the foot extension and the balloon inflation valve, which combines both functions and thereby simplifies the user experience. A return stopper may be provided on the inner catheter assembly with an engaging feature that matches onto the chassis handle, making it easier for the operator to slide the chassis along the elongated shaft of the inner catheter assembly to the correct relative axial position for deployment. The return stopper may also be provided to guide the operator regarding how far to retract the inner catheter assembly after the filament has been tensioned. In some cases, this feature may eliminate the need for the operator to visually refer to alignment marks on the inner catheter assembly when translating the chassis up or down along the inner catheter assembly during the deployment sequence.

[0057] In some embodiments of vascular occlusion assemblies, filament lock deployment may be performed using a filament tension knob rather than using a separate control device on the chassis handle. In such embodiments, the operator can simply turn the tension knob a fixed number of rotations (e.g., 4 times) to tension the filament, then retract the inner catheter assembly, and then continue turning the same tension knob until it stops, thereby deploying the filament lock. This can simplify device operation for the user in some situations. An interlock may be integrated into the filament tension knob mechanism so that the filament tension knob stops after a fixed number of rotations (e.g., 4 times), thereby preventing the operator from inadvertently over-turning the knob before withdrawing the inner catheter assembly.

[0058] At the distal end of the elongated shaft of the internal catheter assembly, the guidewire can exit from the elongated shaft immediately posterior to or proximal to the nose cone of the internal catheter assembly ("rapid exchange") and pass through a guide hole in a tab on the posterior surface of the nose tip of the elongated housing. This configuration may allow for a significant reduction in the external shape of the internal catheter assembly, which may be beneficial in allowing for a reduction in the overall external shape of the nose tip (through which the internal catheter assembly passes).

[0059] The operation of some device embodiments discussed herein for closing access holes in patient vessels may begin while the endovascular procedure is complete and the guidewire is in a fixed position through the access hole and through the associated passage through the patient's vascular lumen and the tissue layer covering the vessel. The actuator assembly with the internal catheter assembly may first be loaded by the guidewire and then advanced through the passage into the access hole (while hemostasis is maintained via manual compression) until visible blood return appears at the proximal end of the internal catheter assembly. The lever may then be raised or otherwise actuated to extend the foot extension and allow the inflation of the inflatable balloon, and the actuator assembly and internal catheter assembly may be pulled proximal until the foot extension engages with the medial surface of the anterior wall of the patient's vessel adjacent to the access hole in the vessel. The hemostatic inflatable balloon immediately inflates and expands outward relative to the periphery of the access hole, thereby providing temporary bleeding control at the access site. Manual compression may now be released.

[0060] The actuator assembly is then slid distally over the internal catheter assembly until it engages with the retaining arm, thereby positioning the nose tip at the end of the elongated housing at the correct distance from the blood vessel (and the tissue layer covering and adjacent to the blood vessel). Next, a button on the chassis is pressed down to deploy the anchor deployer and associated anchor through it into the tissue layer, which may include the fascial layer. Filament tension can then be applied by rotating a large knob at the proximal end of the chassis. The foot extension is then retracted, and the balloon inflation valve is closed by lowering the lever, and the internal catheter assembly is then drawn proximal into the internal lumen of the elongated housing, thereby allowing the filament tension to completely close the access hole in the fascial layer. Finally, the filament lock is deployed by the filament lock assembly by the continued rotation of the suture tension knob until the rotation stops, and the filament is cut by pulling a tab / trigger on the bottom of the chassis. The entire vascular occlusion assembly is then slid proximal to the guidewire, the guidewire is withdrawn from the patient's blood vessel, and the skin wound can be closed in a standard manner.

[0061] Some embodiments of vascular occlusion assemblies may include one or more of the following features or any combination thereof. In some cases, the distal portion of the deployment rod may have a pre-set shape, which allows for a desired tissue layer penetration pattern and an angle of incidence at which the longitudinal axis of the device chassis and elongated housing is positioned at an angle of approximately 45 degrees with respect to the axis of the patient's vessel. In some cases, a 45-degree deployment angle may represent a typical and natural angle for guidewire entry into the lumen of the patient's vessel and associated intervention device. In some cases, a single push-button actuated mechanism using stored energy (e.g., a compressed spring) may be used to advance the deployment rod forward distally by a set distance into a tissue layer such as the fascia. A plunger may then be deployed, which allows a second spring to retract the deployment rod and / or apply tension to the filament without any further input from the operator.

[0062] In some embodiments, a rotary knob on the rear (proximal end) of the chassis may be configured to allow slow, progressive tensioning of the filament until a predetermined tension is reached, after which the filament tension is controlled by a constant force spring, and further rotation of the knob does not affect the filament tension. In some embodiments, subsequent rotation of the knob deploys the filament lock. Retraction features on the chassis and internal catheter assembly may be configured to provide clear, decisive feedback to the operator when the components of the vascular occlusion assembly are in the correct position for deploying the anchor, and subsequently when the internal catheter assembly is fully retracted prior to the deployment of the filament lock. In some cases, a single lever at the proximal end of the elongated shaft of the internal catheter assembly may be configured to actuate both the foot extension and, simultaneously, a balloon inflation valve that allows hemodynamic pressure to fill the inflatable balloon. A simple lever-operated filament cutter may be configured to allow the operator to easily cut the filament immediately before withdrawing the vascular occlusion assembly from the patient.

[0063] With respect to some embodiments, the anchor configuration and filament-anchor connection may be the same as or similar to those discussed in U.S. Patent Publication No. 2021 / 0145421, filed November 18, 2020, by B. Hauck et al., entitled “Vascular Closure Devices and Methods” (which is incorporated herein by reference as a whole). In addition, the filament lock embodiments discussed herein may be the same as or similar to those discussed in the same publication. Some vascular closure assembly embodiments may also include one or more or any combination of the following features: for example, instead of four rotations during deployment, the inner catheter assembly is stopped and removed, and then the rotation of the knob is stopped to stop it, i.e., all rotations are completed to stop it in one sequence, and the inner catheter assembly is removed after all rotations. In some cases, the twist knob does not deploy the filament lock with respect to such embodiments. In some cases, the filament cutting lever may be configured to both deploy the filament lock and cut the filament, allowing the chassis to be removed.

[0064] Referring to Figure 1-6, one embodiment of the actuator assembly 9 and associated internal catheter assembly 10 of the vascular occlusion assembly embodiment 8 is shown. The internal catheter assembly 10 may be an elongated cylindrical device that spans entirely through the chassis 42 and elongated housing 44 of the actuator assembly 9. The internal catheter assembly 10 may also have an elongated tube such as an elongated shaft 46, with a larger rounded hub 11 and lever 13 at the proximal end of the chassis 42, the elongated shaft 46 accompanied by an inflatable balloon 15, a foot extension 14, a balloon inflation valve 48, and a guidewire tracking distal portion nose cone 24. The main device deployment button 12 is located on the chassis 42 for easy ambidextrous use in either the operator's right or left hand. Figure 2 shows the positioner lever 13 in the deployed state, which deploys the foot extension 14, which is located inside the inflatable balloon 15 on the distal side of the internal catheter assembly 10. The lever 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.

[0065] Figure 3 is a cross-sectional view through one embodiment of the chassis 42, in which the positioner lever 13 is raised, resulting in the deployment of the foot extension 14. The lever 13 may be operationally coupled to an actuating wire 50, the distal portion of which is shown in Figures 4-6 in conjunction with the structure and function of the balloon inflation valve 48. This actuating wire 50 may be configured to actuate the foot extension 14 and to move two plugs 20, 21 in parallel with the one-way valve 16. Figures 4 and 4A show one embodiment of the tip 24 of the internal catheter assembly 10, in the pre-deployment state, with the positioner lever 13 in the unstretched 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, as indicated by arrow 49, to allow blood to enter the blood return hole 18 and flow proximal through the inner catheter assembly 10, thereby indicating to the operator that the distal end 52 of the inner catheter assembly 10 is within the inner lumen of the patient's blood vessel, and also indicating that the foot extension 14 can be deployed. There are two holes 17a, 17b in the flexible lumen of the elongated shaft 46 contained within the inflatable balloon 15. There is an additional distal hole 19 of the inflatable balloon 15, which allows the inflatable balloon 15 to inflate when the positioner lever 13 is lifted / actuated, resulting in the plugs 20, 21 and the foot extension 14 moving proximal parallel to the filled position (shown in Figures 5 and 5A).

[0066] Figures 5 and 5A show an embodiment of the tip 24 of the internal catheter assembly 10 in the deployed state, with the positioner lever 13 actuated / lifted as shown in Figures 2 and 3. The foot extension 14 is extended, and the distal plug 20 and proximal plug 21 are paralleled across the two holes 17a and 17b contained within the inflatable balloon 15 to their proximal positions. With the internal catheter assembly 10 in the deployed state, blood can enter the distal hole 19 as indicated by arrow 51, flow through the lumen, and fill the inflatable balloon 15 through the internal holes 17a and 17b. Blood is prevented from flowing out of the inflatable balloon 15 and flowing down into the blood return lumen due to the proximal plug 21 blocking the flow path.

[0067] Figure 6 shows an internal catheter assembly embodiment 10 with the foot extension 14 retracted after deployment. The plugs 20 and 21 are translated parallel to each other across the internal holes 17a and 17b, respectively, as shown in Figures 4 and 4A, returning to their distal positions across the holes 17a and 17b. Any other source of arterial blood or pressurized fluid within the blood vessel can no longer fill the inflatable balloon 15, resulting in the distal plug 20 blocking the flow entering through the distal hole 19. The blood contained within the inflatable balloon 15 in the operating state shown in Figures 5 and 5A can now exit through the proximal hole 17b and flow through the one-way valve 16 into the blood return lumen. This configuration may be configured to implement a feature in which, once blood flows into the inflatable balloon 15, it is never returned to the patient's blood vessels, thereby eliminating any potential risk of a thrombus from stagnant blood in the inflatable balloon 15 being returned to the patient's body.

[0068] Figures 7 and 8 show a one-way valve embodiment 16 with the flapper 23 in an open and closed position, respectively. Figure 7 shows the flapper 23 in the open position away from the proximal seal surface 23a, with the flow channel 16a open to allow blood to flow through the flow channel 16a in the proximal direction past the flapper 23. Figure 8 shows the flapper 23 pressed against the proximal seal surface 23a, with the flow channel 16a closed, thereby preventing any distal flow of blood through the flow channel 16a. Figure 9 shows a cross-section of a device embodiment with a nose cone 24 including a “rapid exchange” configuration, where the guidewire 57 enters the distal tip port 54 of the nose cone 24 and exits from the proximal end of the nose cone 24 at the distal proximal port 53 of the inflatable balloon 15, and the guidewire 57 bypasses the rest of the device until it reaches an alignment hole 25 located within a guidewire clip 22. By passing the guidewire 57 through the alignment hole 25, it eliminates the potential for the deployment rod 39 and anchor 28 to deploy on the opposite side of the guidewire 57 (therefore to capture it), which could result in the internal catheter assembly 10 not being able to be removed from the patient without first removing the guidewire 57. In some cases, the alignment hole 25 may include a slotted lumen, which securely holds the guidewire 57 in a releaseable position under normal lateral load, but is configured to allow the guidewire 57 to move in and out through its lateral slot when a greater lateral load than normal is applied by the user. With respect to such embodiments, a resilient snap-type mating can be achieved.

[0069] Figure 10 shows a notch or retainer 25a in the elongated shaft 46 of the internal catheter assembly embodiment 10. These notches 25a, which may be located on only one side of the elongated shaft 46 of the internal catheter assembly 10, may be configured to provide a decisive stop when sliding the chassis 42 axially along the elongated shaft 46 of the internal catheter assembly 10, and when withdrawing the internal catheter assembly embodiment 10 from the artery when the knob 56 is in the vertical position and the spring-loaded retainer tab 58 is facing upward. Figure 11A shows the action of the retainer interlock 60 for defining the position of the internal catheter assembly 10 relative to the chassis 42. The spring pushes the interlock 60 into the notch of the internal catheter assembly 10. Figure 11B shows that pushing down the retainer interlock 58 (relative to the spring) disengages the interlock 60, allowing the internal catheter assembly 10 to move to its next position. It should be noted that since the notch 25a is located on only one side of the elongated shaft 46, and the retaining tab 58 is also on one side of the knob, the notch 25a and the retaining tab 58 must be rotationally aligned for the retaining interlock 60 to function. Therefore, if the knob 56 is rotated away from rotational alignment by an appropriate amount, such as 180 degrees, as shown in Figures 11A and 11B, the elongated shaft 46 and the retaining tab 25a on it will be able to move freely within the knob 56 and the retaining interlock 60.

[0070] Figure 12 shows a nose tip embodiment of an elongated housing embodiment 44. A filament fairlead sleeve 26, a filament lock 27, two components constituting the filament lock, anchors 28 (in four locations), and a filament tube 29 are included within the nose tip. The four anchors 28 are attached to four filaments 40. These filaments 40 are fed through the filament tube 29 and, in some cases, can be attached to a constant force spring 34 using a simple quick disconnect such as a tension transmission clip 34a. The filament lock 27 can be engaged on the filament 40 by retracting the filament tube 29 from the filament lock 27, allowing the filament lock tongue to spring inward and grasp the filament 40. Since there is a backstop surface 62 for the filament lock element 27, the filament lock elements 27 are configured to move axially parallel along the filament tube 29 when they are pulled back proximal to the backstop.

[0071] Furthermore, with respect to embodiments of the elongated housing, referring to Figures 1-6, 12, 20, and 21, some vascular occlusion assembly embodiments 8 may include an internal catheter assembly 10 including an elongated shaft 46, the elongated shaft 46 having a proximal end, a distal end 52, a distal portion, an axial length, and a guidewire lumen 55. In some embodiments, the guidewire lumen extends proximal from a distal port 54 at the distal end 52 of the elongated shaft 46 to a proximal port 53 located in the distal portion, as shown in Figure 9. The vascular occlusion assembly 8 also includes an actuator assembly 9 having a chassis portion 42 and a plurality of anchor deployers 68, each anchor deployer 68 may include a deploying rod 39, an anchor 28 that can be removably fixed to the distal end of the deploying rod 39, and a filament 40 fixed to each anchor 28. The elongated housing 44 of the actuator assembly 9 has a proximal end fixed to the distal end of the chassis portion 42, and the housing 44 may include a distal end 45 and an inner lumen 43 extending along the elongated housing 44 to the distal end 45 of the elongated housing 44. The inner lumen 43 may include an inner surface contour configured to be slidably positioned on the outer surface of the elongated shaft 46 of the inner catheter assembly 10.

[0072] The elongated housing embodiment 44 also includes a plurality of anchor expander lumens 74 configured to be slidably arranged around each anchor expander 68, each anchor expander lumen 74 extending axially along the elongated housing 44 or along any other suitable path along the elongated housing 44, and may terminate distally at a distal port 76 located within the distal portion 72 of the elongated housing 44. Some embodiments of the elongated housing 44 may further include a guidewire relief slot 47, which is located within the inner lumen 43 through a wall portion of the elongated housing 44, and extends proximal from the distal end 106 of the inner lumen 43 to the proximal end 108 of the guidewire relief slot 47, and is configured to accommodate a guidewire extending outward from the proximal port 53 of the guidewire lumen 55 of the elongated shaft 46. In addition, in some cases, a guidewire retaining clip 22 extending outward from the elongated housing 44 may be positioned proximal to the proximal end 108 of the guidewire relief slot 47.

[0073] Some vascular closure assembly embodiments 8 include an actuator assembly 9 having a chassis portion 42 and a plurality of anchor expanders 68, each anchor expander 68 may include an expander rod 39, an anchor 28 which can be removably fixed to the distal end of the expander rod 39, and a filament 40 fixed to each anchor 28. The actuator assembly 9 of such embodiments may also include an elongated housing 44, the elongated housing 44 having a proximal end fixed to the distal end of the chassis portion 42, a distal end 45, and an inner lumen 43 extending along the elongated housing 44 to the distal end 45 of the elongated housing 44. The elongated housing also includes a plurality of anchor expander lumens 74 configured to be slidably positioned around each anchor expander 68, each anchor expander lumen 74 extending axially along the elongated housing 44 or along any other suitable path along the elongated housing 44 and may terminate distally at a distal port 76 located within the distal portion of the elongated housing 44. The elongated housing also includes a plurality of filament holders 110 positioned proximal to the distal port 76 of the anchor expander lumen 74, each filament holder 110 may be configured to releasably secure a portion of the respective filament 40. In some cases, each of the filament holders 110 may include a segmented tube configuration, which may include a tubular structure with a segment 112 in the wall structure of the filament holder, the segment 112 extending entirely through the wall of the tubular structure and along the entire axial length of the tubular structure.

[0074] With respect to such a filament holder embodiment 110, if it is made from a flexible and elastic material, and an inner lumen 114 is positioned around each filament 40, and a division 112 extends along the axial length of the division tube 110, the filaments 40 positioned within the inner lumen 114 can be releasedly fixed within the inner lumen 114 under normal use and tissue interactions during the deployment and positioning of the vascular closure assembly 8, but release the filaments 40 when under load associated with the deployment of the anchor deployer 68 and the subsequent tensioning of the filaments 40. With respect to some embodiments, the division tubes of some filament holder embodiments 110 may include polymers having a durometer hardness range of about 20 Shore D to about 80 Shore D. In some cases, the elongated housing 44 may further include a plurality of anchor pockets 116. The anchor pockets 116 are positioned adjacent to each distal port 76 of the anchor expander lumen 74 and may be configured to receive each anchor 28, allowing the sharp distal tip of each anchor 28 to be positioned below the nominal outer surface shape of the distal portion of the elongated housing 44 while the anchor expander 68 is in an unexpanded state.

[0075] Some vascular occlusion assembly embodiments 8 include a chassis 42, an elongated housing 44 having its proximal end fixed to the distal end of the chassis 42, and a plurality of anchor expanders 68 configured to extend from the distal portion of the elongated housing 44, each anchor expander 68 may include an anchor 28 and a filament 40 fixed to the anchor 28. The vascular occlusion assembly 8 may further include a filament lock assembly 70 including a filament tube 29 and one or more filament locks 27. The filament lock 27 includes an inner lumen, which may be positioned on the outer surface of the distal portion of the filament tube 29. The filament lock assembly 70 may further include a fairlead sleeve 26 positioned on the filament tube 29 and axially adjacent to the filament lock 27, having an inner lumen positioned distal to it. Such embodiments may further include a polymer bushing 66 positioned between the fairlead sleeve 26 and the adjacent filament lock 27. In some cases, the polymer bushing 66 may include a polymer such as nylon or polyimide. Such a polymer bushing 66 may be configured to prevent ohmic contact and possible electrolysis between the filament lock 27 and the axially adjacent fairlead sleeve 26, the fairlead sleeve 26 may, in some cases, be made of a different metallic material than that of the filament lock 27.

[0076] Figure 13 shows a cross-sectional view of the chassis embodiment 42 in the cocked-load position, ready for deployment. The platen catch 30a of the platen latch 30 grips the deployment rod platen 32. The deployment rod platen 32 can be driven forward by a compression spring 33 when the platen latch trigger 30 is pressed or otherwise actuated. A tensioner, which may include a constant force spring 34, is operationally coupled to the plunger 35 using a tension transmission clip 34a. The plunger 35 is held in the loaded position by the trigger latch lever 31. When the deployment rod platen 32 is driven forward by the compression spring 33, the deployment rod 39, to which the anchor 28 is attached, is driven through the fascial tissue layer 64, as shown in Figure 17. In some embodiments, when the deployment rod platen 32 reaches the end of its advance, the deployment rod platen 32 pushes up the latch lever 31, disengaging it from the plunger 35, allowing the plunger 35 to be pulled back by the constant force spring 34 until the plunger 35 engages with the thumb screw 36.

[0077] Some vascular occlusion assembly embodiments 8 may include an actuator assembly 9 which may include a chassis 42 with distal and proximal ends. The plunger 35 may be movable proximal to the chassis 42 over a retinal length starting from the distal position of the plunger 35, as shown in Figure 13. The tensioner 34 has a first end fixed to the chassis 42 and a second end releasably fixed to the plunger 35 using a tension transmission clip 34a, and is configured to continuously apply tension proximal to the plunger 35 relative to the chassis 42 over the retinal length of the deployment rod 39 and filament 40. A trigger latch 31 may be configured to releasably fix the plunger 35 at the distal position against the proximal force applied to the plunger 35 by the tensioner 34. The platen 32 may be able to move distally relative to the plunger 35 from a proximal cocked position to a distal position over its extended length, which activates the trigger latch 31, releases the plunger 35, and allows for the proximal translation of the plunger 35 over its retracted length.

[0078] A compression spring 33 having a first end operably coupled to a plunger 35 and a second end operably coupled to a platen 32 may be configured to apply a distal force to the platen 32 from the proximal cocked position of the platen 32 to the distal position of the platen 32 over its extended length. In some cases, the platen 32 moves in a linear motion constrained to the plunger 35 when the compression spring 33 is actuated or released. A platen latch 30 may be operably coupled to the chassis 42, enabling the operation of the platen latch 30, but with a configuration that prevents distal translation of the platen latch 30 relative to the chassis 42. The platen latch 30 may include a platen catch 30a operably coupled to the platen 32, which fixes the platen 32 in a releasable position in the proximal cocked position. The actuation or deployment button 12 may be operationally coupled to the platen latch 30 and configured to actuate the platen latch 30 to disengage the platen catch 30a from the platen 32.

[0079] The actuator assembly 9 further comprises an elongated housing 44, the elongated housing 44 having its proximal end fixed to the distal end 42 of the chassis, and a plurality of anchor deployers 68. Each anchor deployer 68 may be slidably positioned within its respective anchor deployer lumen 74 of the elongated housing 44. In some cases, each anchor deployer 68 may include a deploying rod 39 having an elongated elastic configuration, which is operably coupled to a platen 32, so that distal translation of the platen 32 results in distal translation of the deploying rod 39. An anchor 28 may, in some cases, be detachably fixed to the distal end of the deploying rod 39. In some cases, a plunger 35 may include a tubular configuration constrained to move proximal in the linear axial direction relative to the chassis 42 from its distal position. The platen 32 may, in some cases, be positioned within the inner lumen of the tubular plunger 35 and be axially movable. In some embodiments, the proximal portion of the plunger 35 may include a threaded barrel portion.

[0080] In some embodiments, the trigger latch 31 may include a pivot configuration having a proximal end 118 pivotably coupled to the chassis 42 and a distal end including a distally facing engaging surface 120, the distally facing engaging surface 120 engaging with the proximal facing latch surface 122 of the plunger 35. In some embodiments, the tensioner 34 may include a constant tension spring, such as a wound ribbon-shaped clock spring. In some embodiments, the compression spring 33 may include a helically wound cylindrical or conical spring.

[0081] With respect to such an actuator assembly embodiment 9, a method for operating the actuator assembly 9 may include using an actuation button 12 operably coupled to the chassis 42 to actuate the platen latch 30 of the actuator assembly 9, thereby releasing the compression spring 33, which is operably coupled between the plunger 35 and the platen 32, from its compressed state. Subsequently, under the distal force generated by the released compression spring 33, the platen 32 and its associated deployment rod 39, which is operably fixed to it, are axially translated distally relative to the plunger 35 and the chassis 42. The trigger latch 31 can then be actuated using the platen 32 as the platen 32 is translated distally, thereby subsequently releasing the plunger 35 from its fixed distal position. The method may then include axially translating the plunger, platen, and deployment rod fixed to the platen in the proximal direction under a proximal force generated by the tensioner 34, the tensioner 34 being fixed to the chassis 42 and releasably fixed to the plunger 35 using a tension transmission clip 34a.

[0082] Figure 14 shows the initial part of an anchor deployment embodiment, where the platen latch 30 is pressed down, which results in a compression spring 33 causing the deployment rod platen 32 to move distally, which releases the latch lever 31. As the deployment rod platen 32 moves distally, it may be configured to drive four anchors 28 distally to a position below the tissue layer 64, as shown in Figure 17, since the anchors 28 are attached to the end of the deployment rod 39. Figure 15 shows a cross-sectional view of the second part of the deployment sequence. After the latch lever 31 is lifted by the deployment rod platen 32, the plunger 35 slides proximal until the plunger 35 engages with the thumb screw 36. During this sequence, as the deployment rod platen 32 slides proximal, it may be configured to pull the deployment rod 39 out of the tissue layer 64, leaving the anchors 28 (with filaments attached) below the tissue layer 64.

[0083] Figure 16 shows the next steps in the deployment sequence embodiment. Once the plunger 35 engages with the thumb screw 36, the thumb screw 36 can be turned, which continues the retraction of the plunger 35 in a controlled manner. The filament 40 is attached to the constant force spring 34 through a tension transmission clip 34a. When the tension in the filament 40 reaches equilibrium with the constant force spring 34, the tension transmission clip 34a and the associated tensioner 34 disengage from the plunger 35. As the plunger 35 is retracted by further rotation of the thumb screw 36, the end of the filament tube 29 engages at a specified distance, resulting in the filament tube 29 retracting (moving proximally) from the filament lock 27, allowing the filament lock 27 to engage with the filament 40, as shown in Figure 19. Finally, the filament 40 is cut by the operation of the filament cutter 38 shown in Figures 14-16, disconnecting them from the constant force spring 34. The filament cutter 38 is configured to be actuated as a separate step by pulling backward a lever on the filament cutter 38 that extends downward from the chassis 42. Pulling backward the lever on the filament cutter 38 causes the filament cutter blade (not shown) to pivot upward into the adjacent tensioned filaments 40 (not shown), thereby cutting them and enabling the withdrawal of the vascular closure assembly 8.

[0084] In some vascular closure assembly embodiments 8, the deployment of the filament lock 27 and the subsequent cutting of the filament 40 can be performed sequentially with a single action by the operator by the operation / retraction of the filament tube 29. Figures 30-32 show schematic representations of the nose tip of an elongated housing 44 and chassis 42 with multiple separations illustrating an embodiment for performing such a process in partial cross-section. Figure 30 shows the filament tube 29 positioned at its most distal location, with the filament lock 27, filament sleeve 26, and bushing 66 positioned above the distal end portion of the filament tube 29 within the elongated housing 44. The axial length of the engagement 126 of the filament lock 27, filament sleeve 26, and bushing 66 with the distal end portion of the filament tube 29 is represented by the bracket 126. The axial length of the engagement 126 represents the amount of proximal retraction of the filament tube 29 required to fully deploy the filament lock 27, filament sleeve 26, and bushing 66 from the filament tube 29.

[0085] The intermediate portion of the filament tube 29, including an elongated passage 128 through the wall portion of the filament tube 29, is also shown in Figure 30, and the distal end of the elongated passage 128 includes a first cutting edge 130. The intermediate portion of the filament tube 29 passes through the lumen 133 of the cutting block 132, which has a second cutting edge 134 located at its distal end. The cutting block 132, the lumen 133, and the associated first cutting edge 130 can take any suitable form, such as a tubular member with a sharp distal end. In some cases, the outer surface of the filament tube 29, the inner surface of the lumen 133, and the first and second cutting edges 130, 134 may be configured to generate a shear cutting function such that, as the filament tube 29 is retracted proximal to the first cutting edge 130 and the second cutting edge 134 become one and eventually pass each other, as indicated by the arrow 136. The axial separation between the first cutting edge 130 and the second cutting edge 134, as shown in Figure 30 when the filament tube 29 is in its most distal position, may be referred to as the cutting stroke length, as indicated by the bracket 137. In some cases, it may be important that the cutting stroke length 137 is greater than the axial length of the engagement 126 in order to achieve proper sequential deployment of the filament anchor 27 and subsequent cutting of the filament 40.

[0086] Figure 30 also shows a schematic representation of the proximal portion of the chassis 42, which illustrates a coupling embodiment between the filament tube 29 and the elongated shaft 46 of the internal catheter assembly 10. The coupling embodiment between them includes a tension block 138 fixed to the elongated shaft 46 and having an internal lumen 140, the tension block 138 being configured to be slidably positioned on the outer surface of the nominal portion of the filament tube 29. A tab 142 is fixed to the filament tube 29 proximal to the tension block 138 and has a lateral dimension that is too large to pass through the internal lumen 140, thereby allowing the filament tube 29 to slide within the lumen 140 of the tension block 138 until contact is made between the tab 142 of the filament tube 29 and the tension block 138. Subsequently, further proximal retraction of the elongated shaft 46 and tension block 138, as indicated by arrow 136, will impart proximal retraction force to the tab 142 and filament tube 29.

[0087] Figure 31 illustrates the effect of proximal retraction of the filament tube embodiment 29 shown in Figure 30 using proximal retraction of the elongated shaft 46. In Figure 31, the filament tube 29 is retracted proximally, thereby completely retracting the distal portion and distal end of the filament tube 29 from the filament lock 27, filament sleeve 26, and bushing 66, and thus fully unfolding these elements onto the suture 40 as shown. The proximal retraction of the filament tube 29 brings the first cutting edge 130 close to the second cutting edge 134, and the filament 40 passes between the first cutting edge 130 and the second cutting edge 134, from the inner lumen of the filament tube 29 to a position inside the chassis 42 but outside the lumen of the filament tube 29. Therefore, in Figure 31, the filament lock 27, filament sleeve 26, and filament bushing 66 are fully deployed, and the first cutting edge 130 and the second cutting edge 134 are prepared to sever the filament 40 as the filament tube 29 retracts further proximally. Figure 32 illustrates the intermediate portion of the filament tube 29 and cutting block 132 after the filament tube 29 has retracted further proximally following the relative positions shown in Figure 31. In Figure 32, the filament 40 has been cut, and the first cutting edge 130 is now positioned proximally to the second cutting edge 134.

[0088] Figure 17 shows the distal end of the nose tip of an elongated housing embodiment 44, with the deployment rod 39 extending distally, and the anchor 28 attached to the end of these deployment rods 39. Figure 17 also shows the filament 40 attached to the anchor 28 and how the filament 40 is fed through a centrally located filament tube 29. Figure 18 shows the deployed anchor 28. The tissue layer 64 and the passage through it are not shown, but the anchor 28 may be engaged below the tissue layer 64, and the anchor 28 may be restricted around the passage. Figure 19 shows the components of the device that remains inside the patient, i.e., the implant. The filament lock 27 is in the deployed state, and the locking tab springs inward over the filament 40, and thus engages with the four filaments 28, tightly tightening them together, preventing relative movement between the tightly tightened portion of the four filaments 40 and the locking tab, and preventing them from loosening. The four anchors 28 attached to the filament 40 will be tensed and pulled, thus generating clusters of tissue layers 64 (not shown) that are positioned across the passage, resulting in occlusion of the access opening in the artery.

[0089] As discussed above, some vascular occlusion assembly embodiments 8 may include an anchor expander 68, which includes an expander rod 39 having a pre-formed (or curved) configuration that may, in some cases, include a smooth, continuous curve. Some such vascular occlusion assembly embodiments 8 may include an actuator assembly 9 having a chassis portion 42 and an elongated housing 44, the elongated housing 44 having its proximal end fixed to the distal end of the chassis portion 42, a distal end extending away from the chassis portion 42, a distal portion 72 which may include a nose tip, and a plurality of anchor expander lumens 74. In some cases, each anchor expander lumen 74 may extend axially along the elongated housing 44 and terminate distally at a distal port 76 located within the distal portion 72 of the elongated housing 44.

[0090] Multiple anchor expanders 68 may each be slidably positioned within their respective anchor expander lumen 74 of an elongated housing 44. Each anchor expander 68 may include an expander rod 39, which includes an elongated elastic structure and a pre-formed distal portion 78, the pre-formed distal portion 78 having a curved shape when relaxed and a straight shape when constrained within their respective anchor expander lumen 74, and the expander rod 39 is configured to extend from each distal port 76 along a curved path such that its extension has a curved shape when relaxed. Each anchor expander 68 also includes an anchor 28 removablely fixed to the distal end of the expander rod 39, some anchor embodiments configured to resist proximal retraction in tissue. A filament 40 may be fixed to each anchor 28. In some such embodiments, the pre-formed distal portion 78 may have a pre-formed outer shape that lies in a plane without compound curvature.

[0091] In some embodiments, the pre-formed distal portion 78 of each deployment rod 39 is configured to extend distally from each distal port 76 until the distal end of the deployment rod 39 is positioned at a tissue penetration position at a tissue penetration angle, with the distal end of the elongated housing 44 positioned adjacent to the tissue layer 64 at an deployment angle inclined with respect to the tissue layer 64. In some embodiments, the elongated housing 44 and each pre-formed distal portion 78 of the deployment rod 39 are configured to extend the deployment rod 39 and engage with the tissue layer 64 at a tissue penetration angle, with the elongated housing 44 positioned at an deployment angle of approximately 40 to 50 degrees relative to the patient.

[0092] In some cases, the deployment rods 39 of a plurality of anchor deployers 68 may include at least two head-side deployment rods 82, whose distal ends extend laterally from the distal portion 72 of the elongated housing 44 and away from each other, as shown in Figure 26. The plurality of anchor deployers 68 may also include at least two tail-side deployment rods 84, which extend away from the distal portion of the elongated housing 44 and below the head-side deployment rods 82. In some cases, the pre-formed distal portions 78 of at least two head-side deployment rods 82 are in the same plane 86 when extended and deployed, as shown in Figures 24 and 25, forming a relative angle 104 between them of about 180 degrees, but this can be between about 160 and about 200 degrees. In some embodiments, the pre-formed distal portions 78 of at least two caudal deployment rods 84 are located in their respective planes, positioned at an angle 88 of about 70 to 125 degrees relative to each other, more specifically, about 70 to 110 degrees, as shown in Figure 24. In some embodiments, the plane of the pre-formed distal portion 78 of a cranial deployment rod 82 is positioned between the plane of the pre-formed distal portion 78 of an adjacent caudal deployment rod 84, and the relative angle 102 may be about 30 to 75 degrees, more specifically, about 30 to 55 degrees. In some cases, the radius of curvature 90 of the pre-formed distal portion 78 of the cranial deployment rod 82, as shown in Figure 26, may be about 22 mm to 30 mm. In some such embodiments, the radius of curvature 92 of the pre-formed distal portion 78 of the caudal deployment rod 84 may be about 12 mm to 18 mm, as shown in Figure 27.

[0093] In some embodiments, the deployment rods 39 are configured to move axially parallel to the elongated housing 44, but can be fixed against rotation around their respective longitudinal axes 92. Figure 22 shows four deployment rods 39, each of which has a proximal end fixed to the platen 32, so that rotation of the deployment rods 39 around their longitudinal axes relative to the platen 32, chassis 42, and elongated housing 44 is prevented. The deployment rod embodiment 39 shown in Figure 22-27 includes an anchor engagement portion 94, which extends proximal to the distal end of the deployment rod 39 and is angled in the opposite direction to that of the curved outer shape of the pre-formed distal portion 78. In some cases, the anchor engagement portion 94 of each deployment rod 39 extends proximal to the distal end of the deployment rod 39 for a distance of up to about 0.5 to about 1.5 times the axial length of the anchor 28. In some embodiments, the anchor engagement portion 94 of each deployment rod 39 is angled in the opposite direction to the curved outer shape of the pre-formed distal portion 78 at an angle 96 of about 16 to 22 degrees.

[0094] In some embodiments, the pre-formed distal portion 78 of the cranial deployment rod 82 is configured to include a nominal distal tip angle 98 (without the anchor engagement portion 94) of about 80 to 90 degrees with respect to the longitudinal axis 92 of the deployment rod 39 positioned proximal to the pre-formed distal portion 78, while the pre-formed distal portion 78 is positioned in a relaxed, unconstrained state, as shown in Figure 26. In some cases, the pre-curved distal portion 78 of the caudal deployment rod 84 is configured to include a nominal distal tip angle 100 (without the anchor engagement portion 94) of about 110 to 130 degrees with respect to the longitudinal axis 92 of the deployment rod 39 positioned proximal to the pre-formed distal portion 78, while the pre-formed distal portion 78 is positioned in a relaxed, unconstrained state, as shown in Figure 27. In some cases, the pre-formed distal portion 78 of the cranial deployment rod 82 may be configured to include a lateral displacement of the distal end of the deployment rod 39 from the longitudinal axis 92 of the deployment rod 39, which is perpendicular to the distal end, by approximately 20 mm to approximately 30 mm, while the pre-formed distal portion 78 of the deployment rod 39 is in a relaxed and unconstrained state. In addition, the pre-formed distal portion 78 of the caudal deployment rod 84 may be configured to include a lateral displacement of the distal end of the deployment rod 39 from the longitudinal axis 92 of the deployment rod 39, which is perpendicular to the distal end, by approximately 20 mm to approximately 30 mm, while the pre-formed distal portion 78 of the deployment rod 39 is in a relaxed and unconstrained state.

[0095] Figures 28 and 29 show an embodiment of the vascular closure assembly 8 that may have the same or similar features, dimensions, or materials as those of the vascular closure assembly embodiment 8 discussed above. The actuator assembly 9 of the shown embodiment may include an actuator button 12 and an associated trigger latch 31 that releasably restrains the platen 32 as discussed above. The actuator assembly 9 also includes a deployable button cover 124 configured to slide against the chassis 42 and mechanically capture the actuator button 12 to prevent accidental operation of the assembly. To equip the actuator assembly 9, the deployable button cover 124 may be slid distally to release the actuator button 12 and allow its movement and operation.

[0096] The embodiments illustrated herein can be adequately practiced in the absence of any elements not specifically disclosed herein. For example, in each example herein, any of the terms “comprising,” “consisting essentially of,” and “consisting of” may be substituted for any of the other two terms. The terms and expressions used are for illustrative purposes only, not limitation, and the use of such terms and expressions does not exclude any equivalents of the features or parts thereof shown and described, and various modifications are possible. The terms “a” or “an” may refer to one or more elements of the elements they modify unless it is evident from the context that one or more of the elements being described are being described (for example, “a reagent” may mean one or more reagents). Therefore, while embodiments are specifically disclosed by representative embodiments and optional features, it should be understood that modifications and variations of the concepts disclosed herein may be used by those skilled in the art, and such modifications and variations are considered within the scope of this disclosure.

[0097] With respect to the description detailed above, similar reference numerals used herein refer to similar elements that may have the same or similar dimensions, materials, and construction. While certain forms of the embodiments are illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the embodiments of the invention. Therefore, the invention is not intended to be limited by the detailed description above.

Claims

1. A vascular closure assembly comprising an actuator assembly, The actuator assembly is The chassis section, An elongated housing, the elongated housing having a proximal end fixed to the distal end of the chassis portion, a distal end extending away from the chassis portion, a distal portion, and a plurality of anchor deployer lumens, each anchor deployer lumen extending along the elongated housing and terminating distally at a distal port located within the distal portion of the elongated housing, Multiple anchor expanders and Includes, Each anchor deployer is slidably positioned within the respective anchor deployer lumen of the elongated housing. Each anchor deployer is, A deployment rod comprising an elongated, elastic structure and a pre-formed distal portion, wherein the pre-formed distal portion is configured to extend from each distal port along a curved path, such that it takes on a curved outer shape when relaxed and a straight outer shape when constrained within the lumen of each anchor deployer, and its extension takes on the curved outer shape when relaxed. An anchor removably fixed to the distal end of the deployment rod, wherein the anchor is configured to resist proximal retraction within the tissue, Each anchor has a fixed filament and A vascular closure assembly equipped with the necessary components.

2. The vascular closure assembly according to claim 1, wherein the pre-formed distal portion of each deployment rod is configured to extend distally from each distal port until the distal end of the deployment rod is positioned at a tissue penetration angle, with the distal end of the elongated housing positioned adjacent to the tissue layer and the longitudinal axis of the elongated housing positioned at an inclined deployment angle relative to the tissue layer.

3. The vascular closure assembly according to claim 2, wherein the pre-formed distal portions of the elongated housing and the deployment rod are configured to extend the deployment rod and engage with the tissue layer at a tissue penetration angle when the elongated housing is positioned at an deployment angle of approximately 40 to 50 degrees relative to the patient.

4. The vascular closure assembly according to claim 1, wherein the pre-formed distal portions of each deployment rod lie in a plane.

5. The vascular closure assembly according to claim 1, wherein the deployment rods of the plurality of anchor deployers comprise at least two cranial deployment rods, the distal ends of which extend laterally from the distal portion of the elongated housing and away from each other, and at least two caudal deployment rods that extend away from the distal portion of the elongated housing and below the cranial deployment rods.

6. The vascular closure assembly according to claim 5, wherein the pre-formed distal portions of the at least two cranial deployment rods are in the same plane when extended and deployed.

7. The vascular closure assembly according to claim 5, wherein the pre-formed distal portions of the at least two caudal deployment rods are located in their respective planes, positioned at angles of approximately 70 to 110 degrees relative to each other.

8. The vascular closure assembly according to claim 5, wherein the radius of curvature of the pre-formed distal portion of the cranial deployment rod is approximately 22 mm to approximately 30 mm.

9. The vascular closure assembly according to claim 5, wherein the radius of curvature of the pre-formed distal portion of the caudal deployment rod is approximately 12 mm to approximately 18 mm.

10. The vascular closure device according to claim 1, wherein the deployment rods are configured to move in parallel with respect to the elongated housing, but are fixed in relation to their respective vertical axes.

11. The vascular closure assembly according to claim 1, wherein each of the deployment rods is provided with an anchor engagement portion extending proximal from the distal end of the deployment rod, the anchor engagement portion being angled in the opposite direction to that of the curved outer shape of the pre-formed distal portion.

12. The vascular closure assembly according to claim 11, wherein the anchor engagement portion of each deployment rod extends proximal from the distal end of the deployment rod for a distance of up to approximately 0.5 to approximately 1.5 times the axial length of the anchor.

13. The vascular closure assembly according to claim 11, wherein the anchor engagement portion of each deployment rod is angled at approximately 16 to 22 degrees opposite to the curved outer shape of the pre-formed distal portion.

14. The vascular closure assembly according to claim 5, wherein the pre-formed distal portion of the cranial deployment rod is configured to include a nominal distal tip angle (without the anchor engagement portion) of about 80 to about 90 degrees with respect to the longitudinal axis of the deployment rod positioned proximal to the pre-formed distal portion while the pre-formed distal portion is positioned in a relaxed, unconstrained state.

15. The vascular closure assembly according to claim 5, wherein the pre-curved distal portion of the caudal deployment rod is configured to include a nominal distal tip angle (without the anchor engagement portion) of about 110 to about 130 degrees with respect to the longitudinal axis of the deployment rod positioned proximal to the pre-formed distal portion, while the pre-formed distal portion is positioned in a relaxed, unconstrained state.

16. The vascular closure assembly according to claim 5, wherein the pre-formed distal portion of the cranial deployment rod is configured to include a lateral displacement of the distal tip of the deployment rod from the longitudinal axis of the deployment rod perpendicular to the distal tip by about 20 mm to about 30 mm, when the pre-formed distal portion of the deployment rod is in a relaxed and unconstrained state.

17. The vascular closure assembly according to claim 5, wherein the pre-formed distal portion of the caudal deployment rod is configured to include a lateral displacement of the distal tip of the deployment rod from the longitudinal axis of the deployment rod perpendicular to the distal tip by about 20 mm to about 30 mm, when the pre-formed distal portion of the deployment rod is in a relaxed and unconstrained state.

18. The vascular closure assembly according to claim 1, wherein each of the pre-formed distal portions of the deployment rod includes a smooth, continuous curve.

19. A vascular closure assembly including an actuator assembly, the actuator assembly is The chassis section, A plurality of anchor unfolders, each anchor unfolder comprising an unfolding rod, an anchor removably fixed to the distal end of the unfolding rod, and a filament fixed to each anchor, Long and slender casing Includes, The aforementioned elongated housing is The proximal end is fixed to the distal end of the chassis portion, The distal end and An inner lumen extending along the elongated housing to the distal end of the elongated housing, A plurality of anchor deployer lumens, wherein the plurality of anchor deployer lumens are configured to be slidably arranged around each anchor deployer, and each anchor deployer lumen extends along the elongated housing and terminates distally at a distal port located within the distal portion of the elongated housing, Multiple filament holders positioned proximal to the distal port of the anchor expander lumen, Includes, A vascular closure assembly in which each filament holder is configured to securely and releasably fix a portion of the respective filament.

20. The vascular closure assembly according to claim 19, wherein each of the filament holders comprises a divided tube made of a flexible and elastic material, the divided tube having an inner lumen arranged around each filament and a divided portion extending along the axial length of the divided tube.

21. The vascular closure assembly according to claim 20, wherein the divided tube comprises a polymer.

22. The vascular closure device according to claim 19, wherein the elongated housing further comprises a plurality of anchor pockets, each anchor pocket positioned adjacent to the respective distal port of the anchor deployer lumen, and configured to receive each anchor such that the sharp distal tip of the anchor is positioned below the nominal outer surface shape of the distal portion of the elongated housing while the anchor deployer is in a non-deployed state.

23. A vascular closure assembly, wherein the vascular closure assembly is An internal catheter assembly comprising an elongated shaft, wherein the elongated shaft has a proximal end, a distal end, a distal portion, an axial length, and a guidewire lumen, the guidewire lumen extending proximal from a distal port at the distal end of the elongated shaft to a proximal port located in the distal portion, Actuator assembly and Equipped with, The actuator assembly is The chassis section, A plurality of anchor unfolders, each anchor unfolder comprising an unfolding rod, an anchor removably fixed to the distal end of the unfolding rod, and a filament fixed to each anchor, Long and slender casing Includes, The aforementioned elongated housing is The proximal end is fixed to the distal end of the chassis portion, The distal end and An inner lumen extending along the elongated housing to the distal end of the elongated housing, the inner lumen having an inner surface contour configured to be slidably positioned on the outer surface of the elongated shaft, A plurality of anchor deployer lumens, wherein the plurality of anchor deployer lumens are configured to be slidably arranged around each anchor deployer, and each anchor deployer lumen extends along the elongated housing and terminates distally at a distal port located within the distal portion of the elongated housing, A guidewire relief slot is positioned within the inner lumen through the wall portion of the inner lumen. Includes, A vascular closure assembly wherein the guidewire relief slot extends proximal from the distal end of the inner lumen to the proximal end of the guidewire relief slot and is configured to accommodate a guidewire extending outward from the proximal port of the guidewire lumen of the elongated shaft.

24. The vascular closure assembly according to claim 23, further comprising a guidewire retaining clip extending outward from the elongated housing and positioned proximal to the proximal end of the guidewire relief slot.

25. A vascular closure assembly, wherein the vascular closure assembly is An actuator assembly, wherein the actuator assembly is A chassis having a distal end and a proximal end, A plunger that is capable of translating proximal to the chassis over a retraction length starting from a distal position, A tensioner having a first end fixed to the chassis and a second end releasably fixed to the plunger, wherein the tensioner is configured to continuously apply tension to the plunger over the set length, proximal to the chassis, A trigger latch that fixes the plunger in a releaseable manner at the distal position, opposite to the tensioner, A platen that is capable of distal parallel movement relative to the plunger from a proximal cocked position to a distal position over its extended length, wherein the distal position activates the trigger latch, releases the plunger, and allows the proximal parallel movement of the plunger over its retracted length. A compression spring having a first end operably coupled to the plunger and a second end operably coupled to the platen, wherein the compression spring is configured to apply a distal force to the platen from the proximal cocked position of the platen to the distal position of the platen over the extended length, A platen latch, wherein the platen latch is operably coupled to the chassis with a configuration that enables the operation of the platen latch but prevents distal parallel movement of the platen latch relative to the chassis, and the platen latch includes a platen catch, the platen catch is operably coupled to the platen, and the platen latch fixes the platen in a releasable position in the proximal cock position, An actuation button is configured to be operationally coupled to the platen latch and to actuate the platen latch in order to disengage the platen catch from the platen. An actuator assembly including, An elongated housing, the elongated housing having a proximal end fixed to the distal end of the chassis, Multiple anchor expanders and Equipped with, Each anchor deployer is slidably positioned within the respective anchor deployer lumen of the elongated housing. Each anchor deployer is, A deploying rod having an elongated and elastic structure, wherein the deploying rod is operably coupled to the platen such that distal parallel movement of the platen results in distal parallel movement of the deploying rod, An anchor is removably fixed to the distal end of the aforementioned deployment rod. A vascular closure assembly, including the vascular closure assembly.

26. The vascular closure assembly according to claim 25, wherein the plunger has a tubular configuration constrained to move axially proximal from the distal position of the plunger, and the platen is positioned in the inner lumen of the tubular plunger and is movable in parallel.

27. The vascular closure assembly according to claim 26, wherein the proximal portion of the plunger includes a threaded barrel.

28. The vascular closure assembly according to claim 25, wherein the trigger latch comprises a pivot configuration having a proximal end and a distal end pivotably coupled to the chassis, the distal end includes a distally facing engaging surface, and the distally facing engaging surface engages with the proximal facing latch surface of the plunger.

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

30. The vascular closure assembly according to claim 25, wherein the compression spring comprises a spirally wound cylindrical spring.

31. A method for operating an actuator assembly of a vascular closure assembly, wherein the method is: The method involves using an actuation button operably coupled to the chassis to activate the platen latch of the actuator assembly, thereby releasing the compression spring from its compressed state, wherein the compression spring is operably coupled between the plunger and the platen. Under the distal force generated by the released compression spring, the platen and the deployment rod operably fixed to the platen are moved in parallel in the distal direction relative to the plunger and chassis, The platen is used to activate a trigger latch that fixes the plunger in a releasable position at the distal position, so that the plunger moves distally in parallel, thereby releasing the plunger from the fixed distal position. Under a proximal force generated by a tensioner fixed to the chassis and releasably attached to the plunger, the plunger, platen, and deployment rod fixed to the platen are moved in a parallel direction in the proximal direction. Methods that include...

32. A vascular closure assembly, wherein the vascular closure assembly is Chassis and An elongated housing having a proximal end fixed to the distal end of the chassis, A plurality of anchor unfolders configured to extend from the distal portion of the elongated housing, each anchor unfolder comprising an anchor and a filament fixed to the anchor, Filament lock assembly and Equipped with, The aforementioned filament lock assembly is Filament tube and, A filament lock having an inner lumen, wherein the inner lumen is positioned to cover the outer surface of the distal portion of the filament tube, A fairlead having an inner lumen, wherein the inner lumen is positioned to cover the filament tube adjacent to the filament lock in the axial direction, A polymer bushing is positioned between the fairlead and the filament lock. A vascular closure assembly, including the vascular closure assembly.

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

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

Images