Vascular occlusion device and method

Abstract

Vascular closure assembly embodiments can be used to provide hemostasis at a vascular puncture site or the like. Such vascular puncture or access sites can be created during various percutaneous or minimally invasive medical procedures. Some embodiments of the vascular closure assemblies discussed herein can be useful to address certain clinical issues that may arise during the use of vascular closure devices, such as rapid deployment, convenience, ease of use, and the like. Some of the device embodiments can include two primary components, directed to an actuator assembly (which may optionally include a handle portion) and an inner catheter assembly.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 62 / 937,675, filed on November 19, 2019, by B. Hauck et al. and titled "Vascular Closure Devices", which is incorporated herein by reference in its entirety.

Background Art

[0002] In many percutaneous procedures, a catheter is inserted into an access hole within a blood vessel, such as the femoral artery. Such percutaneous procedures can include minimally invasive cardiovascular procedures, such as, for example, balloon angioplasty procedures, atherectomy procedures, cardiovascular stent deployment, heart valve replacement, and others. During such procedures, a therapeutic catheter can typically be inserted directly into the artery over 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 (if used) from the vasculature. The physician must then prevent or limit the amount of blood leaking through the vascular access hole. Currently, physicians use several methods, such as localized external compression, suture - mediated closure devices, plugs, gels, foams, and similar materials, to close the vascular access hole or otherwise limit post - procedure bleeding from the access hole.

[0003] However, such closure procedures can be time - consuming and can occupy a significant portion of the procedure time. In addition, existing methods are associated with complications such as hematoma or thrombosis. Even further, some of such procedures, particularly suture - mediated closure devices, are known to have a high failure rate in the presence of common vascular diseases such as atherosclerosis and calcification.

Summary of the Invention

Means for Solving the Problems

[0004] Some embodiments of the vascular closure assembly may include an actuator assembly having an elongate housing with an inner lumen that extends along the elongate housing to the distal end of the elongate housing. The elongate housing may also have a distal section and a plurality of anchor deployment lumens. The actuator assembly may also include a plurality of anchor deployers, each of which is slidably disposed within an individual anchor deployment lumen of the elongate housing, and each of which includes a distal end that is configured to extend and flare distally and radially outwardly from the distal section of the elongate housing. The vascular closure assembly may also include an inner catheter assembly having a proximal end, a distal end, a distal section, an axial length sufficient for the distal section to extend distally beyond the distal end of the elongate housing when disposed within its inner lumen, and an outer profile configured to be slidably disposed within the inner lumen of the elongate housing. The inner catheter assembly may further include an inflatable balloon disposed on the distal section of the elongate shaft at an axial position where the elongate shaft may extend distally from the distal end of the elongate housing when disposed within the inner lumen of the elongate housing. The inflatable balloon may have an internal volume that communicates with a balloon inflation lumen, and the balloon inflation lumen extends along the elongate shaft from an inflation port disposed to fluidly communicate with the internal volume of the self-expanding balloon to an inlet port disposed on the elongate shaft.

[0005] Some embodiments of the vascular closure assembly may include an actuator assembly having a chassis portion with an outer shell that forms an internal volume disposed within the outer shell. The actuator assembly may further include an elongate housing having a proximal end fixed to the distal end of the chassis portion, a distal end extending away from the chassis portion, an inner lumen extending along the elongate housing to the distal end of the elongate housing, a distal section, and a plurality of anchor deployer lumens. In some cases, each anchor deployer lumen may axially extend along the elongate housing and terminate distally at a distal port disposed within the distal section of the elongate housing. The actuator assembly may also include a plurality of anchor deployers, each anchor deployer being slidably disposed within an individual anchor deployer lumen of the elongate housing and having a distal end configured to extend and spread distally and radially outwardly from the distal section of the outer housing. For some embodiments, each anchor deployer may include a deployment rod having an axial length greater than its lateral dimension and a distal end extending from the distal section of the elongate housing in response to distal axial deployment, having an elongate resilient configuration. Each anchor deployer may also have an anchor removably fixed to the distal end of the deployment rod and configured to resist proximal retraction within tissue. The vascular closure assembly may also include an inner catheter assembly having a proximal end, a distal end, a distal section, an axial length sufficient for the distal section to extend distally beyond the distal end of the elongate housing when disposed within its inner lumen, and an outer profile configured to be slidably disposed within the inner lumen of the elongate housing. The inner catheter assembly may further include an inflatable balloon disposed on the distal section of the elongate shaft at an axial position where the elongate shaft may extend distally from the distal end of the elongate housing when disposed within the inner lumen of the elongate housing. The inflatable balloon may have an internal volume in fluid communication with a balloon inflation lumen.

[0006] Some embodiments of the actuator assembly may include a chassis portion having an outer shell and an internal volume disposed within the outer shell. The actuator assembly may further include an elongate housing having an axial length greater than its lateral dimension, a proximal end secured to the distal end of the chassis portion, a distal end extending away from the chassis portion, and an inner lumen extending along the elongate housing to the distal end of the elongate housing. The elongate housing may also include a distal section and a filament lumen extending along the elongate housing and terminating at a distal port disposed within the distal section of the elongate housing, and a plurality of anchor deployer lumens. In some cases, each anchor deployer lumen may extend axially along the elongate housing and terminate distally at a distal port disposed within the distal section of the elongate housing. The actuator assembly may also include a plurality of anchor deployers, each anchor deployer being slidably disposed within an individual anchor deployer lumen of the elongate housing and including a distal end configured to extend and splay distally and radially outwardly from the distal section of the elongate housing. With respect to some embodiments, each anchor deployer may include a deployment rod having an axial length greater than its lateral dimension and a distal end extending from the distal section of the elongate housing in response to distal axial deployment, and having an elongate resilient configuration. Each anchor deployer may also include an anchor, respectively, removably secured to the distal end of the deployment rod. Each anchor deployer may also include a filament slidably disposed within the filament lumen of the elongate housing and having a distal end secured to the anchor. The actuator assembly may also include a filament locking mechanism including a filament locking portion disposed at the distal end of the filament lumen and arranged in an operative array with the filaments of the individual plurality of anchor deployers.

[0007] Some embodiments of the catheter assembly may include an elongate shaft having a proximal end, a distal end, a distal segment, and a proximal chassis secured to the proximal end of the elongate shaft. The catheter assembly may also include a self-expanding balloon disposed on the distal segment of the shaft, the self-expanding balloon having a thin compliant shell material and an internal volume in communication with a balloon inflation lumen, the balloon inflation lumen extending along the elongate shaft from an inflation port disposed to be in fluid communication with the internal volume of the self-expanding balloon at an axial position distal to the distal end of the self-expanding balloon to an inlet port disposed on the elongate shaft at an axial position distal to the distal end of the self-expanding balloon. Additionally, the catheter assembly may include a balloon inflation valve configured to controllably open and close the balloon inflation lumen.

[0008] Some embodiments of the filament locking portion may include a tubular structure with a main body portion and a plurality of finger-like portions extending proximally from the main body portion. In some cases, the finger-like portions are configured to be of sufficient axial length and elastically biased toward the central longitudinal axis of the main body portion such that when the finger-like portions are in a relaxed state, the individual distal ends of the finger-like portions self-contract from an expanded state to a relaxed state and crimp onto a filament disposed within the inner lumen of the filament locking portion. Additionally, the finger-like portions may be configured to elastically spread apart in a relative lateral separation to an expanded state sufficient to fit onto the outer surface of the distal end of the filament tube.

[0009] Some embodiments of the method for vascular occlusion may include advancing a vascular occlusion assembly distally toward an access aperture within a blood vessel and a passage disposed within a tissue layer adjacent to the blood vessel. In some cases, the vascular occlusion assembly may be advanced in such a manner while the inner catheter assembly of the vascular occlusion assembly is disposed within the inner lumen of the elongate housing of the actuator assembly of the vascular occlusion assembly. Additionally, the vascular occlusion assembly may be advanced distally in such a manner with the inflatable balloon of the inner catheter assembly extending distally beyond the distal end of the elongate housing. The method may also include inflating the inflatable balloon until contact and hemostasis are established between the outer surface of the self-expanding balloon and the circumferential surface around the access aperture within the blood vessel. The method may further include axially translating the actuator assembly over the inner catheter assembly while holding the inner catheter assembly in an axially fixed position relative to the access aperture within the blood vessel until the distal end of the elongate housing of the actuator assembly is disposed adjacent to the passage within the tissue layer. Thereafter, a plurality of anchor deployers may be deployed using an anchor deployer actuator to extend distally and radially outwardly away from the distal section of the elongate housing of the vascular occlusion assembly. The anchor deployers may further engage at a fixed position disposed about the passage within the tissue layer using the individual anchors of the plurality of anchor deployers. The method may also include applying proximal tension to filaments secured to each of the anchors to pull the anchors closer together by pulling the anchors and the individual portions of the tissue layer secured to each of the anchors together, thereby reducing the lateral dimension of the passage within the tissue layer. For some embodiments, the filament locking portion may be deployed onto the filaments at the distal end of the elongate housing by activating a filament locking mechanism using a tensioning spring to maintain tension on the filaments.

[0010] Some embodiments of the vascular occlusion device may include a filament locking portion having a tubular structure with a main body portion and a plurality of finger-like portions extending proximally from the main body portion. In some cases, the finger-like portions are configured such that when the finger-like portions are in a relaxed state, the individual distal ends of the finger-like portions self-contract from an expanded state to a relaxed state and crimp onto a filament disposed within the inner lumen of the filament locking portion. Additionally, the finger-like portions may be elastically biased toward the central longitudinal axis of the main body portion and have a sufficient axial length such that they elastically spread radially outwardly in a relative lateral separation to an expanded state sufficient to fit onto the outer surface of the distal end of the filament tube. The vascular occlusion assembly may further include a filament tube disposed within the inner lumen of the filament locking portion and a filament disposed within the inner lumen of at least one of the filament locking portions, with the filament locking portion in an expanded state. The vascular occlusion assembly may also have a filament tube actuator configured to axially withdraw the filament tube from within the inner lumen of the filament locking portion.

[0011] Some embodiments of a method for vascular occlusion may include advancing a distal end of an elongate housing of an actuator assembly distally until it is disposed adjacent to a passage within a tissue layer. The method may further include deploying a plurality of anchor deployers from the elongate housing in an asymmetric pattern distally and radially outwardly about the longitudinal axis of the elongate housing, and engaging individual anchors of the plurality of anchor deployers at a fixed position disposed in an asymmetric deployment pattern about the passage within the tissue layer. The anchors are then pulled together, thereby pulling the individual portions of the tissue layer to which each of the anchors and the anchors are attached closer together by applying tension to filaments attached to each of the individual anchors so as to reduce the lateral dimension of the passage within the tissue layer. Next, while maintaining the tension on the filaments, a filament locking portion may be deployed onto the filaments at the distal end of the elongate housing.

[0012] One embodiment will be further described in the following description, examples, claims, and drawings. These features of the embodiment will become clearer from the forms for carrying out the following invention by being considered in connection with the accompanying exemplary drawings. The present invention provides, for example, the following. (Item 1) A vascular occlusion assembly, An actuator assembly, wherein the actuator assembly An elongate housing, the elongate housing having an inner lumen extending along the elongate housing to a distal end of the elongate housing, a distal section, and a plurality of anchor deployer lumens, the elongate housing; A plurality of anchor deployers, each anchor deployer being slidably disposed within an individual deployer lumen of the elongate housing and including a distal end configured to extend and spread from a distal section of the elongate housing, the plurality of anchor deployers An actuator assembly including; An inner catheter assembly, the inner catheter assembly An elongate shaft, the elongate shaft having a proximal end, a distal end, a distal section, an axial length sufficient for the distal section to extend distally beyond a distal end of the elongate housing when disposed within its inner lumen, and an outer profile configured to be slidably disposed within the inner lumen of the elongate housing, the elongate shaft; An inflatable balloon, the inflatable balloon being disposed on the distal section of the elongate shaft at an axial position where it can extend distally from a distal end of the elongate housing when the elongate shaft is disposed within the inner lumen of the elongate housing, the inflatable balloon including an internal volume in communication with a balloon inflation lumen, the balloon inflation lumen extending along the elongate shaft from an inflation port disposed to be in fluid communication with the internal volume of the inflatable balloon to an inlet port disposed on the elongate shaft, the inflatable balloon An inner catheter assembly including; A vascular occlusion assembly comprising. (Item 2) The vascular occlusion assembly according to Item 1, wherein the inflatable balloon comprises a self-expanding balloon and further comprises a balloon inflation valve configured to controllably open and close the balloon inflation lumen. (Item 3) The vascular occlusion assembly according to Item 1, further comprising a guide wire lumen extending along the elongate shaft to a distal guide wire port disposed at a distal end of the elongate shaft. (Item 4) The self-expanding balloon is sized to fit within the inner lumen of the extension housing and is configured to self-expand from a compressed state having a lateral dimension smaller than the outer lateral dimension of the extension shaft to an expanded state having an outer lateral dimension greater than the outer lateral dimension of the extension shaft and configured to occlude an access hole in the wall of a patient's blood vessel, the vascular occlusion assembly of claim 1 having an outer profile. (Item 5) The vascular occlusion assembly of claim 4, wherein the self-expanding balloon has an extended outer profile in the expanded state such that the nominal axial length of the self-expanding balloon exceeds the lateral dimension of the self-expanding balloon. (Item 6) The balloon inflation valve is a plug, the plug having an outer profile that matches the inner profile of the balloon inflation lumen so as to prevent fluid flow through the balloon inflation lumen and is slidably disposed within the balloon inflation lumen, the plug an actuator rod having a distal end fixed to the plug, and a balloon inflation lever, the balloon inflation lever being operably coupled to the proximal end of the actuator rod and disposed on the proximal chassis of the inner catheter assembly, the plug being disposed distal to the inflation port of the balloon inflation lumen such that the plug is slidable from a first position that blocks fluid communication between the inlet portion and the inflation port of the balloon inflation lumen to a second position, the second position being proximal to the first position and proximal to the inflation port such that fluid communication between the inlet port and the inflation port through the balloon inflation lumen is enabled, the balloon inflation lever comprising the vascular occlusion assembly of claim 2. (Item 7) The balloon inflation valve comprises a tubular member configured to be axially displaced within the balloon inflation lumen of the extension shaft, the tubular member having a pair of ports coupled to fluidly communicate with each other and axially positioned to align with the inlet port and the inflation port of the extension shaft when the tubular member is disposed in the open axial position and positioned not to align with the inlet port and the inflation port when in the closed axial position, the vascular occlusion assembly of claim 2. (Item 8) The vascular occlusion assembly according to item 1, further comprising a foot-like extension disposed on the extension shaft within the internal volume of the self-expanding balloon, wherein the foot-like extension extends outwardly from a retracted position where the foot-like extension is substantially disposed within the nominal outer contour of the extension shaft to a deployed position where an outer end portion of the foot-like extension extends radially outwardly from the nominal outer contour of the extension shaft. (Item 9) The vascular occlusion assembly according to item 8, wherein the extension shaft further comprises an insertion alignment mark visually distinguishable by a user, the actuator assembly further comprises a proximal index visually distinguishable by a user, and in the deployed state, the foot-like extension is spaced apart from the distal end of the extension housing by a predetermined axial separation when the insertion alignment mark is axially aligned with the proximal index. (Item 10) The vascular occlusion assembly according to item 9, wherein the proximal index and the insertion alignment mark are positioned such that the predetermined axial separation is between about 260 mm and about 285 mm. (Item 11) The vascular occlusion assembly according to item 9, wherein the extension shaft further comprises a retraction alignment mark visually distinguishable by a user, and the distal end of the self-expanding balloon is disposed within the inner lumen of the extension housing when the retraction alignment mark is axially aligned with the proximal index. (Item 12) A vascular occlusion assembly, An actuator assembly, wherein the actuator assembly comprises An outer shell and a chassis portion having an internal volume disposed within the outer shell, An extension housing having a proximal end fixed to the distal end of the chassis portion, a distal end extending away from the chassis portion, an inner lumen extending along the extension housing to the distal end of the extension housing, a distal section, and a plurality of anchor deployer lumens, each anchor deployer lumen extending axially along the extension housing and terminating distally at a distal port disposed within the distal section of the extension housing, the extension housing; A plurality of anchor deployers, each anchor deployer being slidably disposed within an individual deployer lumen of the extension housing and including a distal end configured to extend and spread from the distal section of the outer housing, each anchor deployer An expansion rod, the expansion rod including an elongate elastic configuration having an axial length greater than a lateral dimension and a distal end extending from a distal section of the elongate housing in response to distal axial expansion, the expansion rod An anchor removably fixed to the distal end of the expansion rod and configured to resist proximal retraction within tissue Comprising a plurality of anchor deployers Including an actuator assembly An inner catheter assembly, the inner catheter assembly An elongate shaft, the elongate shaft including a proximal end, a distal end, a distal section, and an axial length sufficient for the distal section to extend distally beyond the distal end of the elongate housing when disposed within its inner lumen, and an outer profile configured to be slidably disposed within the inner lumen of the elongate housing, the elongate shaft An inflatable balloon, the inflatable balloon being disposed on the distal section of the elongate shaft at an axial position where it can extend distally from the distal end of the elongate housing when the elongate shaft is disposed within the inner lumen of the elongate housing, the inflatable balloon including an internal volume in communication with a balloon inflation lumen, the inflatable balloon Including an inner catheter assembly Comprising a vascular occlusion assembly (Item 13) The vascular occlusion assembly according to item 12, wherein the elongate housing further comprises a filament lumen extending along the elongate housing and terminating at a distal port disposed within the distal section of the elongate housing, each anchor deployer further comprises a filament, the filament being slidably disposed within the filament lumen of the elongate housing and including a distal end fixed to the anchor (Item 14) The vascular occlusion assembly according to item 12, further comprising a handle portion having an upper end fixed to the chassis portion and a proximal chassis fixed to the proximal end of the elongate shaft (Item 15) The vascular occlusion assembly according to item 12, wherein the inflatable balloon comprises a self-expanding balloon and further comprises a balloon inflation valve configured to controllably open and close the balloon inflation lumen (Item 16) The actuator assembly further comprises an inner catheter assembly position locking portion, and the inner catheter assembly position locking portion is configured to releasably fix the inner catheter assembly to the actuator assembly and apply a frictional force to the outer surface of the inner assembly disposed within the inner lumen of the extension body so as to temporarily prevent axial displacement of the inner catheter assembly relative to the actuator assembly. The vascular occlusion assembly according to item 12. (Item 17) An anchor deployer actuator, An anchor deployer carrier, the anchor deployer carrier being slidably disposed relative to the chassis portion and operably coupled to the proximal section of each of the plurality of deployer rods. An anchor deployer carrier, An actuator lever, the actuator lever extending outside the chassis portion and operably coupled to the anchor deployer carrier to translate the anchor deployer carrier distally in response to an actuating translation, thereby axially translating each of the deployer rods distally in response to the actuating translation. An actuator lever Comprising an anchor deployer actuator The vascular occlusion assembly according to item 12, further comprising. (Item 18) The distal section of each of the anchor deployer lumens is configured to provide an outward angular deflection of the anchor deployer extending outwardly from the distal port of the anchor deployer lumen. The vascular occlusion assembly according to item 12. (Item 19) The distal section of each of the anchor deployer lumens has a curved profile relative to the longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen, providing an outward angular deflection of the anchor deployer extending outwardly from the distal port of the anchor deployer lumen. The vascular occlusion assembly according to item 18. (Item 20) The anchor deployer lumen is configured to produce an asymmetric deployment pattern of the anchor deployer relative to the longitudinal axis of the extension housing. The vascular occlusion assembly according to item 18. (Item 21) The axial position and firing axis of each of the anchor deployer lumens are configured to produce the asymmetric deployment pattern relative to the longitudinal axis of the extension housing. The vascular occlusion assembly according to item 20. (Item 22) The curved contour of the distal section of the first anchor deployer lumen comprises a firing axis that forms a first angle with the longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen. The curved contour of the distal section of the second anchor deployer lumen comprises a firing axis that forms a second angle with the longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen. The second angle is different from the first angle. The vascular closure assembly according to item 21. (Item 23) Each anchor of the plurality of anchor deployers includes a sharp distal tip configured to penetrate tissue in a distal direction. The vascular closure assembly according to item 12. (Item 24) Each deployment rod of the plurality of anchor deployers comprises a sharp tissue-piercing tip disposed on the distal end of the deployment rod. The anchor removably fixed to the distal end of the deployment rod has a tubular configuration without a sharp distal tip. The vascular closure assembly according to item 12. (Item 25) The vascular closure assembly according to item 12 further comprises a filament tensioning mechanism configured to controllably apply axial tension to the filaments of the individual plurality of anchor deployers. (Item 26) The vascular closure assembly according to item 12 further comprises a filament locking mechanism disposed at the distal end of the filament lumen. The filament locking mechanism includes a filament locking portion arranged in an operable arrangement with the filaments of the individual plurality of anchor deployers. (Item 27) The filament locking mechanism comprises a filament tube having a distal section slidably disposed within a snug bore in the distal section of the elongate housing, the filament tube having a distal end extending distally beyond the distal shoulder surface of the snug bore, the filament tube being slidably disposed relative to the elongate housing and having an inner lumen centered on the filament and a proximal section; a filament locking portion having an inner lumen centered on the distal end of the filament tube at an axial position distal to the distal shoulder surface of the snug bore, the filament locking portion self-shrinking from an expanded state to a relaxed state when an outward radial support producing the expanded state of the filament tube is removed and configured to crimp onto the filament disposed within the inner lumen of the filament tube. A filament tube actuator, wherein the filament tube actuator is operably coupled to a proximal section of the filament tube and, in response to activation, pushes the filament locking portion from a distal end of the filament tube, and the filament locking portion is configured to axially retract the filament tube relative to the distal shoulder surface so as to be able to crimp onto the filament disposed within an inner lumen of the filament tube. A filament tube actuator The vascular occlusion assembly according to item 26, comprising (Item 28) The vascular occlusion assembly according to item 27, wherein the filament locking mechanism comprises a plurality of filament locking portions disposed axially adjacent to each other on a distal end of the filament tube at an axial position distal to a distal shoulder surface of the closely fitting bore. (Item 29) The vascular occlusion assembly according to item 27, wherein the filament tube comprises a rigid tubular structure made of a high-strength material. (Item 30) The vascular occlusion assembly according to item 27, wherein the filament locking portion comprises a coiled spring filament, and the inner lumen is sized to crimp onto the filament disposed therein when in a contracted state, and the inner lumen can be elastically expanded to a sufficient lateral dimension to fit onto an outer surface of a distal end of the filament tube. (Item 31) The vascular occlusion assembly according to item 26, wherein the filament locking portion comprises a tubular structure, the tubular structure includes a main body portion, and a plurality of finger portions extending proximally from the main body portion, and the finger portions are such that when the finger portions are in a relaxed state, individual distal ends of the finger portions self-contract from an expanded state to a relaxed state and are configured to crimp onto the filament disposed within an inner lumen of the filament locking portion, and have a sufficient axial length and are elastically biased toward a central longitudinal axis of the main body portion, and the finger portions can elastically spread to a sufficient relative lateral separation to an expanded state to fit onto an outer surface of a distal end of the filament tube. (Item 32) The vascular occlusion assembly according to item 31, wherein the filament locking portion comprises from about 3 to about 10 finger portions. (Item 33) The vascular closure assembly of item 12, wherein the actuator assembly further comprises a filament cutter disposed in an operable array with the filaments of the plurality of individual anchor deployers. (Item 34) An actuator assembly, A chassis portion having an outer shell and an internal volume disposed within the outer shell, and An elongate housing having an axial length greater than its lateral dimension, a proximal end secured to the distal end of the chassis portion, a distal end extending away from the chassis portion, an inner lumen extending along the elongate housing to the distal end of the elongate housing, a distal section, a filament lumen extending along the elongate housing and terminating distally at a distal port disposed within the distal section of the elongate housing, and a plurality of anchor deployer lumens, each anchor deployer lumen extending axially along the elongate housing and terminating distally at a distal port disposed within the distal section of the elongate housing. A plurality of anchor deployers, each anchor deployer slidably disposed within an individual deployer lumen of the elongate housing and including a distal end configured to extend and splay from the distal section of the outer housing. A deployment rod including an elongate resilient configuration having an axial length greater than its lateral dimension and a distal end extending from the distal section of the elongate housing in response to distal axial deployment. An anchor removably secured to the distal end of the deployment rod. A filament slidably disposed within the filament lumen of the elongate housing and including a distal end secured to the anchor. A plurality of anchor deployers comprising: A filament locking mechanism disposed at the distal end of the filament lumen and including a filament locking portion disposed in an operable array with the filaments of the plurality of individual anchor deployers. An actuator assembly comprising: (Item 35) An anchor deployer actuator, An anchor deployer carrier slidably disposed relative to the chassis portion and operably coupled to the proximal section of each of the plurality of deployment rods. An actuator lever, wherein the actuator lever extends outside the chassis portion and translates the anchor deployer carrier distally in response to an actuating translation, thereby operably coupling to the anchor deployer carrier for axially translating each of the deployer rods distally in response to the actuating translation, and an actuator lever An anchor deployer actuator comprising The actuator assembly according to item 34, further comprising (Item 36) Each distal section of the anchor deployer lumen has a curved profile relative to the longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen, providing an outward angular deflection of the anchor deployer extending outwardly from the distal port of the anchor deployer lumen. The actuator assembly according to item 34 (Item 37) The curved profile of each distal section of the anchor deployer lumen has a launch axis forming an angle of about 15 degrees to about 35 degrees relative to the longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen. The actuator assembly according to item 36 (Item 38) Each distal end of the anchor deployer lumen has a recessed pocket, the recessed pocket having an inner surface configured to receive the outer surface contour of an individual anchor disposed within the recessed pocket with a tight fit therebetween. The actuator assembly according to item 34 (Item 39) The curved profile of the distal section of the first anchor deployer lumen has a launch axis forming a first angle relative to the longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen, and the curved profile of the distal section of the second anchor deployer lumen has a launch axis forming a second angle relative to the longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen, the second angle being different from the first angle. The actuator assembly according to item 36 (Item 40) Each anchor of the plurality of anchor deployers includes a sharp distal tip configured to penetrate distally into tissue. The actuator assembly according to item 34 (Item 41) Each deployment rod of the plurality of anchor deployers comprises a sharp tissue piercing tip disposed on the distal end of the deployment rod, and the anchor removably fixed to the distal end of the deployment rod has a tubular configuration without a sharp distal tip, the actuator assembly according to item 34. (Item 42) The actuator assembly according to item 34, further comprising a filament tensioning mechanism configured to controllably apply axial tension to the filaments of the individual plurality of anchor deployers. (Item 43) The filament tensioning mechanism includes a filament end fixed to the filaments of the plurality of anchor deployers and a tensioning spring operably fixed to the filament end, and the filament end is movable in parallel from a first position where tension is not applied to the filaments by the filament end to a second position where the tension is applied to the filaments through the filament end by the tensioning spring, the actuator assembly according to item 42. (Item 44) The filament locking mechanism a filament tube having a distal section slidably disposed within a closely fitting bore in the distal section of the elongate housing, the filament tube having a distal end extending distally beyond the distal shoulder surface of the closely fitting bore, being slidably disposed relative to the elongate housing, having an inner lumen disposed about the filament, and having a proximal section; a filament tube a filament locking portion having an inner lumen centered on the distal end of the filament tube at an axial position distal to the distal shoulder surface of the closely fitting bore, self - contracting from an expanded state to a relaxed state when the outward radial support producing the expanded state of the filament tube is removed, and configured to crimp onto the filament disposed within the inner lumen of the filament tube; a filament locking portion A filament tube actuator, wherein the filament tube actuator is operably coupled to a proximal section of the filament tube and, in response to activation, pushes the filament locking portion from a distal end of the filament tube and is configured to axially retract the filament tube relative to the distal shoulder surface so as to enable the filament locking portion to crimp onto the filament disposed within an inner lumen of the filament tube. The actuator assembly according to item 34, comprising the above. (Item 45) The actuator assembly according to item 44, wherein the filament locking portion comprises a coiled spring filament, the inner lumen is sized to crimp onto the filament disposed therein when in a contracted state, and the inner lumen can elastically expand to a lateral dimension sufficient to fit over an outer surface of a distal end of the filament tube. (Item 46) The actuator assembly according to item 44, wherein the filament locking portion comprises a tubular structure including a main body portion and a plurality of finger-like portions extending proximally from the main body portion, the finger-like portions being of sufficient axial length such that when the finger-like portions are in a relaxed state, individual distal ends of the finger-like portions self-contract from an expanded state to a relaxed state and are configured to crimp onto the filament disposed within an inner lumen of the filament locking portion, being elastically biased toward a central longitudinal axis of the main body portion, and the finger-like portions can elastically spread to a relative lateral separation to an expanded state sufficient to fit over an outer surface of a distal end of the filament tube. (Item 47) The actuator assembly according to item 34, further comprising a filament cutter disposed in an operable arrangement with filaments of the plurality of individual anchor deployers. (Item 48) The filament comprises a suture, the filament cutter comprises a suture cutter, the suture cutter includes a sharp blade, the sharp blade is angled towards the suture, and the blade is configured to translate laterally within a sliding portion disposed within a bore with respect to the suture such that the blade approaches the suture such that it contacts the suture during lateral translation and cuts through it prior to the end of a corresponding lateral actuation stroke, the actuator assembly of claim 47. (Claim 49) A catheter assembly comprising an elongate shaft including a proximal end, a distal end, and a distal segment, a proximal chassis secured to the proximal end of the elongate shaft, a self-expanding balloon disposed on the distal segment of the shaft, the self-expanding balloon including a thin compliant shell material and an internal volume in fluid communication with a balloon inflation lumen, the balloon inflation lumen extending from an inflation port disposed along the elongate shaft in fluid communication with the internal volume of the self-expanding balloon to an inlet port disposed on the elongate shaft at an axial position distal to the distal end of the self-expanding balloon, and a balloon inflation valve configured to controllably open and close the balloon inflation lumen The catheter assembly comprising. (Claim 50) The catheter assembly of claim 49, further comprising a foot-like extension disposed on the elongate shaft within the internal volume of the self-expanding balloon, the foot-like extension being configured to extend outwardly from a retracted position in which the foot-like portion is substantially disposed within the nominal outer profile of the shaft to a deployed position in which an outer end of the foot-like extension extends radially outwardly from the nominal outer profile of the shaft substantially perpendicular to the longitudinal axis of the elongate shaft. (Claim 51) The catheter assembly of claim 50, further comprising a foot-like extension actuator configured to vary the state of the foot-like extension between the retracted position and the deployed position. (Claim 52) The catheter assembly of claim 49, further comprising a blood return lumen extending proximally from the distal end of the elongate shaft to a proximal port of the blood return lumen disposed proximal to the self-expanding balloon. (Claim 53) The catheter assembly of item 49, further comprising a guide wire lumen extending along the elongating shaft to a distal guide wire port disposed at the distal end of the elongating shaft. (Item 54) A filament locking portion, the filament locking portion comprising a tubular structure with a main body portion and a plurality of finger-like portions extending proximally from the main body portion, the finger-like portions being such that when the finger-like portions are in the relaxed state, the individual distal ends of the finger-like portions self-contract from an expanded state to a relaxed state and are configured to crimp onto a filament disposed within the inner lumen of the filament locking portion, having a sufficient axial length such that, elastically biased towards the central longitudinal axis of the main body portion, the finger-like portions can be elastically diffused to a relative lateral separation up to the expanded state, a filament locking portion. (Item 55) The vascular occlusion assembly of item 54, wherein the filament locking portion comprises from about 3 to about 10 finger-like portions. (Item 56) A method for vascular occlusion, advancing a vascular occlusion assembly distally towards an access hole in a blood vessel and a passage disposed within a tissue layer adjacent to the blood vessel while the inflatable balloon of the inner catheter assembly of the vascular occlusion assembly extends distally beyond the distal end of the elongating housing and the inner catheter assembly of the vascular occlusion assembly is disposed within the inner lumen of the elongating housing of the vascular occlusion assembly; inflating the inflatable balloon until contact and hemostasis are established between the outer surface of the inflatable balloon and the circumferential surface around the access hole in the blood vessel; while holding the inner catheter assembly in an axially fixed position relative to the access hole in the blood vessel, axially translating the actuator assembly over the inner catheter assembly until the distal end of the elongating housing of the actuator assembly is disposed adjacent to the passage within the tissue layer; using an anchor deployer actuator to deploy a plurality of anchor deployers distally and radially outwardly away from a distal section of the elongating housing of the vascular occlusion assembly and engaging the individual anchors of the plurality of anchor deployers at a fixed position disposed about the passage within the tissue layer. Pulling both the anchor and the individual portions of the tissue layer fixed to each of the anchors, thereby applying a proximal tension to the filaments fixed to each of the anchors so as to reduce the lateral dimension of the passage within the tissue layer, and pulling the anchors closer together; Deploying a filament locking portion onto the filament at the distal end of the elongate housing by activating the filament locking mechanism while maintaining tension on the filament using the spreading spring; A method comprising. (Item 57) The method according to item 56, wherein advancing the vascular occlusion assembly distally comprises advancing the vascular occlusion system distally over a guide wire. (Item 58) The method according to item 57, wherein advancing the vascular occlusion assembly distally over the guide wire comprises advancing the vascular occlusion assembly distally with the inner catheter assembly releasably fixed to the actuator assembly and preventing relative axial displacement therebetween. (Item 59) The method according to item 56, further comprising deploying the foot-like extension from the elongate shaft of the inner catheter assembly from a position within the internal volume of the inflatable balloon such that the foot-like extension extends radially outwardly from the elongate shaft. (Item 60) The method according to item 59, further comprising retracting the vascular occlusion assembly proximally until contact between the foot-like extension and the inner surface of the patient's blood vessel adjacent to the access hole prevents further proximal displacement and the axial length of the inflatable balloon overlaps the access hole. (Item 61) The method according to item 60, wherein the inflatable balloon comprises a self-expanding balloon, and expanding the self-expanding balloon comprises opening a balloon inflation valve of the inner catheter assembly and allowing pressurized blood from within the patient's blood vessel to flow through a balloon inflation lumen of the inner catheter assembly into the internal volume of the self-expanding balloon. (Item 62) Deploying the plurality of anchor deployers distally and radially outwardly away from the distal section of the elongate housing includes deploying the plurality of anchor deployers in an asymmetric pattern about the longitudinal axis of the elongate housing, the method of claim 56. (Claim 63) The method of claim 56, further comprising securing the anchors to the tissue layer at a location disposed about a passageway within the tissue layer while the plurality of anchor deployers are being deployed. (Claim 64) Securing the anchors to the tissue layer at a location disposed about a passageway within the tissue layer includes penetrating the tissue layer with each of the anchors of the respective individual anchor deployers and removing each anchor from its respective deployment rod at a location directly beneath the tissue layer, the method of claim 63. (Claim 65) The method of claim 56, further comprising rotating the actuator assembly until the longitudinal axis of the elongate housing is substantially perpendicular to the longitudinal axis of the blood vessel prior to retracting the deployment rods of the anchor deployers proximally after the anchor deployers have been deployed. (Claim 66) The method of claim 56, further comprising retracting the deployment rods of the anchor deployers proximally into the elongate housing by releasing the anchor deployer actuator after the plurality of anchor deployers have been deployed. (Claim 67) Applying proximal tension to the filaments secured to each of the anchors includes operating a filament tensioning mechanism configured to controllably apply tension to the filaments, the method of claim 56. (Claim 68) Operating the filament tensioning mechanism includes controllably translating a filament end secured to the filament and the tensioning spring, the method of claim 67. (Claim 69) Activating the filament locking mechanism includes depressing a filament tube actuator coupled to a filament tube disposed about the filament within the outer housing, thereby retracting the filament tube proximally and urging at least one filament locking portion in an expanded state from the distal end of the filament tube onto the filament, the method of claim 56. (Claim 70) The filament locking portion has a self - contracting configuration, and once the outward radial support of the filament tube is removed by retracting proximally past the distal shoulder of a snug - fitting bore centered on the distal end of the filament tube, the self - contracting filament locking portion contracts in a relaxed state across the filament, thereby further enabling the at least one filament locking portion to be crimped onto and against each other on the filament, the method according to item 69. (Item 71) The method according to item 56, further comprising cutting the filament proximal to the deployed filament locking portion by actuating a filament cutter of the actuator assembly disposed in an operable array with the filament. (Item 72) The sharp blade of the filament cutter is disposed within a sliding portion, and actuating the filament cutter of the actuator assembly comprises translating the sliding portion and the sharp blade parallel to the filament within a bore and approaching the filament during the lateral translation and contacting the filament, thereby cutting through the filament, the method according to item 56. (Item 73) A vascular occlusion device, A filament locking portion, the filament locking portion comprising a tubular structure with a main body portion and a plurality of finger - like portions extending proximally from the main body portion, the finger - like portions having an axial length sufficient such that when the finger - like portions are in the relaxed state, the individual distal ends of the finger - like portions self - contract from an expanded state to a relaxed state and are configured to crimp onto a filament disposed within an inner lumen of the filament locking portion, elastically biased toward a central longitudinal axis of the main body portion, and the finger - like portions being elastically diffused in relative lateral separation to an expanded state sufficient to fit onto an outer surface of a distal end of a filament tube; a filament locking portion; A filament tube disposed within an inner lumen of the filament locking portion with the filament locking portion in the expanded state; At least one filament disposed within an inner lumen of the filament locking portion; A filament tube actuator configured to axially remove the filament tube from inside the lumen of the filament locking portion A vascular occlusion assembly comprising the same. (Item 74) The vascular occlusion assembly according to item 73, wherein the filament locking portion includes about 3 to about 10 finger-like portions. (Item 75) The vascular occlusion assembly according to item 74, wherein the filament locking portion includes about 4 to about 6 finger-like portions. (Item 76) The vascular occlusion assembly according to item 73, wherein the filament locking portion is made of a superelastic material. (Item 77) The vascular occlusion assembly according to item 76, wherein the superelastic material of the filament locking portion is a nickel-titanium alloy. (Item 78) A method for vascular occlusion, comprising: Advancing the actuator assembly distally until the distal end of the extension housing of the actuator assembly is disposed adjacent to a passage in the tissue layer; Deploying a plurality of anchor deployers from the extension housing in a distal and radially outward direction in an asymmetric pattern about the longitudinal axis of the extension housing, and engaging the individual anchors of the plurality of anchor deployers at fixed positions disposed in an asymmetric deployment pattern about the passage in the tissue layer with the tissue layer; Applying tension to the filaments fixed to each of the individual anchors to pull the anchors together so as to reduce the lateral dimension of the passage in the tissue layer by pulling together the anchors and the individual portions of the tissue layer fixed to each of the anchors; Deploying a filament locking portion onto the filament at the distal end of the extension housing while maintaining tension on the filament; A method including the above steps.

Brief Description of the Drawings

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[0064] The drawings are intended to illustrate, but not limit, certain exemplary embodiments. For clarity and ease of illustration, the drawings may not be drawn to scale, and in some instances, various aspects may be shown exaggerated or enlarged to facilitate understanding of a particular embodiment.

Mode for Carrying Out the Invention

[0065] Detailed Description As discussed above, after a percutaneous catheterization procedure or any other procedure that requires vascular access using an access pore in a patient's blood vessel, a physician typically must address the issue of bleeding from the vascular access pore once a therapeutic or diagnostic device or devices have been removed from the access pore in the patient's blood vessel. Some suitable device and method embodiments for such procedures are discussed in U.S. Patent Application No. 15 / 277,542 (now U.S. Patent No. 10,639,020), entitled "VASCULAR CLOSURE DEVICE," filed on September 27, 2016, and issued on May 5, 2020, by Thomas Larzon, et al.; U.S. Patent Application No. 16 / 190,654, entitled "COLLAPSIBLE TUBE FOR HEMOSTASIS," filed on November 14, 2018, by Thomas Larzon, et al.; and U.S. Patent Application No. 16 / 190,694, entitled "TISSUE CLOSURE DEVICE," filed on November 14, 2018, by Henrik Nyman, et al. (each of which is incorporated herein by reference in its entirety). Any of the features, dimensions, or materials of the embodiments discussed in these incorporated references may be combined with, or substituted for, any suitable features, dimensions, or materials of the device and method embodiments discussed herein. Additionally, the embodiments discussed herein may be used, or combined with each other, in any suitable manner. In particular, any of the features, dimensions, or materials of any of the embodiments discussed herein may be combined with, or substituted for, any of the features, dimensions, or materials of any other suitable embodiment discussed herein.

[0066] Some embodiments of the vascular occlusion assemblies discussed herein may be useful for addressing certain clinical issues that can arise during the use of vascular occlusion devices, such as rapid deployment, convenience, ease of use, and equivalents. Some of the device embodiments may include two primary components that are directed to an actuator assembly (optionally including a handle portion) and an inner catheter assembly. The inner catheter assembly may include a small blood return lumen for providing an indication that the distal tip is in fluid communication with the internal lumen of the blood vessel, a foot-like extension for positioning against the anterior wall of the blood vessel, and an inflatable balloon for maintaining hemostasis during the vascular occlusion procedure. The inner catheter assembly is frequently discussed herein as a component of the vascular occlusion assembly, but in some cases, such inner catheter assembly embodiments may function as stand-alone catheter assemblies having the same or similar features, dimensions, and materials. Actuator embodiments may include a plurality of anchor deployers and associated anchors, or any other suitable number of anchor deployers, including four or more such anchor deployers and associated anchors, or filaments such as sutures having a distal end secured to one of the plurality of anchors each. The anchors may be embedded and / or engaged within the tissue layer at locations circumferentially disposed about an access hole within the blood vessel by a deployment rod actuated by an actuator lever on the actuator assembly. The actuator assembly may also include a spring for applying tension to the filament and closing the access hole, and a filament locking portion for holding the filament in place once the connection to the actuator assembly is severed.

[0067] Generally, during use of such an embodiment, the operation of the device embodiment for closing the access hole can commence once the underlying therapeutic or diagnostic procedure is complete and generally while the guidewire used for the procedure remains in place. The actuator assembly, along with the inner catheter assembly, is first loaded over the guidewire and then advanced into the access hole until visible blood return appears on the proximal end of the blood return lumen of the inner catheter assembly (during which time hemostasis is maintained via manual compression). The lever is then activated to deploy the foot-like extension, and the actuator assembly and inner catheter assembly are pulled proximally until the foot-like extension engages the anterior wall of the blood vessel. Next, another lever is actuated to open the balloon inflation valve, enabling blood pressure to fill the inflatable hemostasis balloon, thereby providing temporary blood leak control or hemostasis control at the access site. Manual compression may then be reduced or released.

[0068] The actuator assembly is then slid distally over the inner catheter assembly until it is aligned with the insertion alignment mark, thereby positioning the nose tip of the actuator assembly at the correct distance from the blood vessel to the tissue layer disposed above the blood vessel, such as the fascia layer. The actuator lever on the actuator assembly is then pulled to deploy the anchor deployer and associated anchor. Filament tension can then be applied by rotating the large knob at the base of the actuator assembly. The inflatable balloon is then removed, enabling the filament tension to completely close the access hole. Finally, the filament lock can be deployed by pulling the small lever on the actuator assembly, and the suture filament is cut by pressing the filament cutter button on the proximal side surface of the actuator assembly. The device is now slid off the guidewire, and the skin wound can be closed in a standard manner.

[0069] Generally, referring to FIGS. 1-6, an embodiment of a vascular occlusion assembly 10 that can be used for such vascular occlusion techniques may include an actuator assembly 12 having a chassis portion 14 with an outer shell 16 and an internal volume 18 disposed within the outer shell 16. The actuator assembly 12 may further include an elongate housing 22 having an axial length that exceeds its lateral dimension, a proximal end 24 secured to the distal end 26 of the chassis portion 14, and a distal end 28 extending away from the chassis portion 14. The elongate housing 22 may also include an inner lumen 32 that extends along the elongate housing 22 to the distal end 28 of the elongate housing 22, a distal section 34, and a filament lumen 36 disposed within a filament tube 37 that extends along the elongate housing 22 and terminates distally at a distal port 38 disposed within the distal section 34 of the elongate housing 22 as shown in FIGS. 19-21. The elongate housing 22 may further include a plurality of anchor deployer lumens 42. Each anchor deployer lumen 42 may extend axially along a curved or straight path along the elongate housing 22 and terminate distally at a distal port 44 disposed within the distal section 34 of the elongate housing 22. In some cases, the handle portion 46 of the actuator assembly 12 may have an upper end 48 secured to the chassis portion 14.

[0070] As shown in FIG. 4, the actuator assembly 12 may also include a plurality of anchor deployers 52, each of which is slidably disposed within an individual anchor deployer lumen 42 of the elongate housing 22 and includes a distal end 54 that, as shown in FIG. 29, is configured to extend and spread from the distal section 34 of the elongate housing 22 in a distal and radially outward orientation. For some embodiments, each anchor deployer 52 may include a deployment rod 56 having an axial length that exceeds a transverse dimension and a distal end 58 that extends from the distal section 34 of the elongate housing 22 in response to distal axial deployment, and having an elongate resilient configuration. The anchor 62 is removably or otherwise releasably secured to the distal end 58 of the deployment rod 56. In some cases, the tubular structure at the proximal end of the anchor embodiment 62 may be configured to slide over and engage the distal end 58 of the deployment rod 56 such that a distally directed force from the distal end 58 of the deployment rod 56 is readily transmitted to the anchor 62. However, as shown in FIG. 46, once the anchor 62 is deployed within the tissue layer 64, the distal end 58 of the deployment rod 56 may be configured to resist proximal retraction within the tissue 64 after deployment such that it slides out of the tubular structure at the proximal end of the anchor embodiment 62 in response to proximal retraction of the deployment rod 56. The filament 66 is slidably disposed within the filament lumen 36 of the elongate housing 22 and may include a distal end 68 that is secured to the anchor 62. Additionally, as shown in FIG. 21, the actuator assembly 12 may include a filament locking mechanism 72 disposed at the distal ends 74 of the filament lumen 36 and the filament tube 37, the filament locking mechanism 72 including filament locking portions 76 that are arranged in an operable array with the filaments 66 of the individual plurality of anchor deployers 52.

[0071] Some embodiments of the vascular occlusion assembly may also include an inner catheter assembly 78. The inner catheter assembly 78 may have an elongate shaft 82 that includes a proximal end 84, a distal end 86, a distal section 88, and an axial length sufficient such that when disposed within its inner lumen 32, the distal section 88 extends distally beyond the distal end 28 of the elongate housing 22. The inner catheter assembly 78 may further include an outer profile that is configured to be slidably disposed within the inner lumen 32 of the elongate housing 22. The proximal chassis 92 may be secured to the proximal end 84 of the elongate shaft 82 of the inner catheter assembly 78. Optionally, an inflatable balloon, which may be configured as a self-expanding balloon 94, may be disposed on the distal section 88 of the elongate shaft 82 in an axial position such that when the elongate shaft 82 is disposed within the inner lumen 32 of the elongate housing 22, the inflatable balloon extends distally from the distal end 28 of the elongate housing 22. The self-expanding balloon 94 may include a wall portion 96 made of a thin compliant material and an internal volume 98 that communicates with a balloon inflation lumen 102, as shown in FIGS. 9 and 10. The self-expanding balloon 94 may also have an outer profile that is configured to be slidably disposed within the inner lumen 32 of the elongate housing 22 when the self-expanding balloon 94 is in a contracted state.

[0072] As shown in FIGS. 35 and 36, the balloon inflation lumen 102 may extend from an inflation port 104, which is disposed along the elongating shaft 82 and in fluid communication with the interior volume 98 of the self-expanding balloon 94, to an inlet port 106, which is disposed on the elongating shaft 82 at an axial position distal to the distal end 108 of the self-expanding balloon 94. Such an inner catheter assembly embodiment 78 may also have a balloon inflation valve 112, which is configured to controllably open and close the balloon inflation lumen 102. As discussed above, the inner catheter assembly embodiments 78 discussed herein are generally referred to as components of the vascular closure assembly embodiment 10, but the inner catheter assembly embodiments 78 discussed herein may also function and be used as stand-alone catheter assembly embodiments 78 having the same or similar features, dimensions, and materials. Such stand-alone catheter assembly embodiments may be used for a variety of suitable applications, including providing hemostasis during coronary artery bypass graft procedures as well as procedures other than vascular closure procedures such as the like.

[0073] As further shown in FIGS. 9 and 10, the inner catheter assembly 78 of the vascular occlusion assembly 10 may further include a guidewire lumen 114 that extends along the elongate shaft 82 to a distal guidewire port 116 disposed at the distal end 86 of the elongate shaft 82 and that houses a guidewire 117, as shown in FIGS. 35 and 36. The inner catheter assembly 78 may further include a blood return lumen 118, as shown in FIGS. 9 and 10. The blood return lumen 118 may extend proximally from a distal port 120 disposed on the distal segment 88 of the elongate shaft 82, as shown in FIG. 2, to a proximal port 122 of the blood return lumen 118 disposed on the proximal chassis 92. The distal port 120 may similarly be disposed on the distal segment 88 of the elongate shaft 82 at an axial position proximal to the self-expanding balloon 94, as also shown in FIG. 2. With respect to embodiments of the inflatable balloon 94 that are not configured as self-expanding, the balloon inflation lumen may be arranged to be in fluid communication with an inflation pressure source (not shown), such as a syringe or other inflation pump, rather than the inlet port 106.

[0074] For some embodiments, the self-expanding balloon 94 may have an outer profile that is configured to self-expand from a compressed state having an outer lateral dimension that, in the lateral dimension, is sized to fit within the inner lumen 32 of the elongate housing 22 and that is larger than the outer lateral dimension of the elongate shaft 82 in the expanded state. The self-expanding balloon 94 in the expanded state may also be sized and configured in the lateral dimension to completely fill and occlude the access hole 124 that is disposed within the wall portion 126 of the patient's blood vessel 128. The self-expanding balloon 94 may further include an outer profile having an elongate shape or contour such that, in the expanded state, the nominal axial length of the self-expanding balloon 94 exceeds the lateral dimension of the self-expanding balloon 94 when in the expanded state. In some cases, the self-expanding balloon 94 in the expanded state may have an outer lateral dimension of from about 8 mm to about 15 mm and a nominal axial length of from about 10 mm to about 25 mm. In some instances, the wall portion 96 of the self-expanding balloon 94 may have a thickness of from about 0.02 mm to about 0.06 mm and may be made from one or more materials including urethane, polyurethane, and silicone.

[0075] In some cases, it may be desirable to control the inflation of the self-expanding balloon 94. Thus, the balloon inflation valve 112 may be configured to reversibly open and close the balloon inflation lumen 102 and control the flow rate of blood therethrough. Some embodiments of the balloon inflation valve 112 may include a plug 134, which has an outer contour 136 that conforms to the inner contour 138 of the balloon inflation lumen 102 to prevent the flow of fluid, such as blood, therethrough, as shown in FIGS. 9, 10, 36, and 37. This configuration also allows the plug 134 to be slidably disposed within the balloon inflation lumen 102 between an axial position that blocks the flow of blood from the inlet port 106 to the inflation port 104 and an axial position that allows the flow of blood through the balloon inflation lumen 102. The actuator rod 142 may have a distal end 144 that is fixed to the plug 134 and a proximal end 146 that is operably coupled or otherwise fixed to a balloon inflation lever 148 on the proximal chassis 92, as shown in FIG. 11. The balloon inflation lever 148 may be slidable from a first position in which the plug 134 is disposed distal to the inflation port 104 of the balloon inflation lumen 102, thereby blocking fluid communication between the inlet portion 106 and the inflation port 104 of the balloon inflation lumen 102. The balloon inflation lever 148 may also be slidable to a second position that is proximal to the first position and proximal to the inflation port 104 to allow fluid communication between the inlet port 106 and the inflation port 104 through the balloon inflation lumen 102. For some embodiments, the inlet port 106 may be disposed on the extension shaft 82 distal to the distal end 108 of the self-expanding balloon 94.

[0076] In some cases, during deployment of the self-expanding balloon 94, the self-expanding balloon 94 is filled with a fluid such as blood from within the interior 150 of the blood vessel 128, expands significantly, and may assume a mushroom shape configuration. The expanded head of the mushroom configuration of the self-expanding balloon 94 is disposed outside the blood vessel 128 adjacent to the access hole 124 within the blood vessel 128. Such an expansion of the outer surface 154 of the self-expanding balloon 94 can increase the friction between the peripheral surface 156 of the access hole 124 within the blood vessel 128 and the outer surface 154 of the self-expanding balloon 94. In some instances, this increased friction can, in turn, impede the axial movement of the self-expanding balloon 94 with respect to the access hole 124 and other structures, such as the movement of the inner catheter assembly 78 within the inner lumen 150 of the blood vessel 128. Additionally, in some cases, the self-expanding balloon 94 can become trapped when withdrawn into the distal end 158 of the inner lumen 32 of the elongate housing 22 of the actuator assembly 12. Thus, with respect to the internal volume 98 of the self-expanding balloon 94, it may be useful to provide a venting feature that provides fluid communication between the internal volume 98 of the self-expanding balloon 94, which is disposed centrally about the inner catheter assembly 78 of the blood vessel occlusion assembly 10 outside the inner lumen 150 of the blood vessel 128 being treated, and the ambient pressure. Such venting can typically occur while the balloon inflation lumen 102, which is disposed between ports 104 and 106, is in a closed state that prevents flow therethrough.

[0077] Based on the foregoing, with respect to some embodiments, a portion of the balloon inflation lumen 102 of the extension shaft 82 that extends proximal to the balloon inflation port 104 may be present, and this proximal portion may be vented to the outside atmosphere. With respect to such embodiments, when the stopper 134 of the balloon inflation valve 112 is disposed distal to the balloon inflation port 104 with the fluid communication between the inlet port 106 and the inflation port 104 blocked, the inflation port 104 can thus be vented by the proximal portion of the balloon inflation lumen 102 to the outside ambient atmosphere in order to allow the internal volume 98 of the self-expanding balloon 94 to contract to a collapsed state when not actively inflated. This arrangement can facilitate the axial translation of the self-expanding balloon 94 within the blood vessel lumen 150 and the axial withdrawal of the self-expanding balloon 94 into the inner lumen 32 of the extension housing 22 of the self-expanding balloon 94 when not actively inflated.

[0078] Alternatively, similar control of the inflation of the self-expanding balloon 94 may be achieved using a balloon inflation valve embodiment 112 that includes a cooperating pair of lamellae (or a tubular member with individual interacting lamella layer portions) configured with a plurality of ports that interact in response to translation between two or more relative axial positions to achieve the inflation and optional ventilation functions of the balloon inflation valve features discussed above. In some cases, a first lamella 162 disposed parallel to a second lamella 164 may be seated tightly together, with one lamella such as the first lamella 162 optionally fixed in relation to the elongate shaft 82, but the lamellae 162, 164 are sufficiently free to be axially movable relative to each other in distal and proximal directions. In one position (e.g., when the foot-like extension 166 is stowed as shown in FIG. 40), fluid communication between the blood vessel lumen 150 and the internal volume 98 of the self-expanding balloon 94 is blocked, but fluid communication between the internal volume 98 of the self-expanding balloon 94 and ventilation to the surrounding environment may be open. In a second position (e.g., when the foot-like extension 166 is deployed as shown in FIG. 41), fluid communication between the blood vessel lumen 150 and the internal volume 98 of the self-expanding balloon 94 is open, and fluid communication between the internal volume 98 of the self-expanding balloon 94 and the surrounding environment is closed or otherwise blocked.

[0079] Also, in some situations, it may be useful to combine the functions of certain elements of the balloon inflation valve embodiment 112 and the foot-like extension actuator embodiment 168. For example, in some cases, the actuator rod 142 of the balloon inflation valve 112 discussed above, which is used to axially translate the plug 134, may also be used to actuate the deployment of the foot-like extension 166 (discussed in more detail below) such that when the balloon inflation valve 112 is opened by retracting the actuator rod 142 proximally, the foot-like extension 166 is simultaneously deployed by a portion (not shown) of the actuator rod 142 that extends distally and is operably coupled to the foot-like extension 166.

[0080] Regarding some embodiments of such balloon inflation valve embodiment 112, the mated lamellae 162, 164 are configured to be axially displaced relative to each other by the axial displacement of the tubular valve member 174 relative to the extension shaft 82 and include or alternatively may be made from a portion of the balloon inflation lumen 102 of the tubular valve member 174 and the extension shaft 82. The tubular valve member 174 may also be positioned such that when the tubular valve member 174 is disposed in the open axial position, as shown in FIG. 41, it is aligned with the inlet port 106 and the inflation port 104 of the extension shaft 82, and when in the closed axial position, as shown in FIG. 40, it is positioned such that it is not aligned with the inlet port 106 and the inflation port 104 and may have a first port 176 and a second port 178 that are coupled to be in fluid communication with each other. Additionally, the vent port 179 of the first lamella 162 may be aligned with a third port 180 of the tubular valve member 174 in the closed state, which may be configured to provide ventilation to the ambient atmosphere through the central lumen 181 of the tubular valve member 174, which may extend from the internal volume 98 of the self-expanding balloon 94 and in some cases to the proximal chassis 92. Flow through the central lumen 181 may be restricted by a seal 183 disposed within the central lumen 181 proximal to the second port 178 and distal to the first port 180. In some cases, the outer surface contour 182 of the tubular valve member 174 may be configured to have a tight fit with the inner surface contour 138 of the balloon inflation lumen 102 of the extension shaft 82. Such a tight fit is tight enough to prevent the flow of liquids such as blood between the outer surface contour 182 and the inner surface contour 138, but may be spaced apart enough to allow relative axial displacement between the tubular valve member 174 and the extension shaft 82.

[0081] The inner catheter assembly 78 may further include a foot-like extension 166, which is disposed on the extension shaft 82, and the foot-like extension 166 is substantially disposed within the nominal outer contour 184 of the shaft 82 as shown in FIG. 38. From the retracted position, the outer end 186 of the foot-like extension 166 may be configured to extend radially outwardly from the nominal outer contour 184 of the extension shaft 82 to an extended position. In some cases, the foot-like extension 166 may be disposed substantially perpendicular to the longitudinal axis 192 of the extension shaft 82 when deployed and extended. In one case, the foot-like extension 166 may extend radially outwardly and proximally from the nominal outer contour 184 of the extension shaft 82 as shown in FIG. 39, forming an angle 185 of about 60 degrees to about 90 degrees with the longitudinal axis 192 of the extension shaft 82. For some embodiments, the foot-like extension 166 may have an axial position on the extension shaft 82 that keeps the foot-like extension 166 disposed within the internal volume 98 of the self-expanding balloon 94. In other embodiments, the foot-like extension 166 may be axially coextensive with the self-expanding balloon 94 but disposed in a position such that it is not disposed within the internal volume 98 of the self-expanding balloon 94. For such embodiments, the self-expanding balloon may include an open slot (not shown) disposed centered about the foot-like extension 166 within its structure. Such an open slot within the outer profile of the self-expanding balloon 94 may allow the foot-like extension 166 to be axially coextensive with the self-expanding balloon 94 while still being deployed outwardly without interfering with the wall portion 96 of the self-expanding balloon 94 or any other suitable version of the inflatable balloon embodiment.

[0082] Regarding some embodiments, the foot-like extension 166 is disposed about the axial center point 194 of the self-expanding balloon 94 and may serve to ensure an overlap between the outer surface 154 of the self-expanding balloon 94 and the peripheral surface 156 of the access hole 124 when the self-expanding balloon 94 is deployed. Regarding other embodiments, the foot-like extension 166 may be disposed distal to the axial center point 194 of the self-expanding balloon 94 and proximal to the distal end 108 of the self-expanding balloon 94. Regarding still other embodiments, the foot-like extension 166 may be disposed proximal to the axial center point 194 of the self-expanding balloon 94 and distal to the proximal end 196 of the self-expanding balloon 94, as shown in the embodiments of FIGS. 38 and 39.

[0083] The foot-like extension actuator 168 may be configured to vary the state of the foot-like extension 166 between a retracted position and a deployed position. In some cases, the foot-like extension actuator 168 may include a foot-like extension actuator rod 198 disposed within the actuator rod lumen 204 of the extension shaft 82, as shown in FIGS. 9-11. The foot-like extension actuator rod 198 may have a distal end 199 that is operably and / or pivotally secured to the foot-like extension 166. The foot-like extension actuator rod 198 may be configured to rotate or otherwise extend the foot-like extension 166 in a generally outward radial direction in response to an axial translation of the foot-like extension actuator rod 198. The foot-like extension actuator rod 198 may further have a proximal end 206 that is secured to a foot-like portion actuating lever 208 on the proximal chassis 92. The foot-like portion actuating lever 208 may have a first position in which the foot-like extension 166 is disposed in the retracted position and a second position in which the foot-like extension 166 is disposed in the deployed position.

[0084] Regarding some embodiments, the foot-like extension 166 may be operably coupled to a foot-like extension housing 170, as shown in FIGS. 42-45. Such a foot-like extension housing 170 may be configured to form a portion 82' of the extension shaft 82 of the inner catheter assembly 78. Some embodiments of the foot-like extension housing 170 and the foot-like extension 166 may be configured such that the curved slots 171 of the foot-like extension 166 engage corresponding curved rails 172 of the foot-like extension housing 170, each having the same or a similar radius of curvature. This sliding and meshing coupling between the individual curved slots 171 and the curved rails 172 allows the outer end 186 of the foot-like extension 166 to rotate and extend radially outward in response to an axial translation in the proximal direction of the inner end 187 of the foot-like extension 166 due to the force applied thereto by the actuation of the foot-like extension actuator 168 and the associated axial translation of the foot-like extension actuator rod 198, as shown in FIG. 45. In other embodiments of the foot-like extension 166 and the foot-like extension actuator rod 198, the foot-like extension 166 may be configured to pivot about a pivot axis in response to the actuation and axial translation of the foot-like extension actuator rod 198, which may have a distal end thereof operably and rotatably coupled to the foot-like extension 166 at a position radially outward from the pivot axis, as shown in any of the foot-like extension embodiments 166 of FIGS. 38-41. The embodiments of the inner catheter assembly 78 shown in FIGS. 38-41 may also include a foot-like extension housing 170 and an associated portion 82' of the extension shaft 82, as shown in FIGS. 42-45 and discussed above.

[0085] With respect to some embodiments, the actuator assembly 12 may further include an inner catheter assembly position latch 212, as shown in FIG. 7. In some cases, the inner catheter assembly position latch 212 may be configured to apply a frictional force to the outer surface 214 of the extension shaft 82 of the inner catheter assembly 78 while the inner catheter assembly 78 is disposed within the inner lumen 32 of the extension housing 22. The controllable application of this frictional force between the inner catheter assembly position latch 212 (secured to the chassis portion 14) and the inner catheter assembly 78 may be used to releasably secure the inner catheter assembly 78 to the actuator assembly 12 and temporarily prevent axial displacement of the inner catheter assembly 78 relative to the actuator assembly 12. This arrangement may be useful when it is desirable to axially translate the actuator assembly 12 in parallel with the inner catheter assembly 78, such as when the vascular closure assembly 10 is first advanced into a position adjacent to the access hole 124 within the blood vessel 128 and the passage 216 within the tissue layer 64 shown in FIG. 46 disposed above the access hole 124. With respect to some embodiments, the inner catheter assembly position latch 212 is arranged in a latched position with a degree of inward radial intrusion sufficient to contact the outer surface 214 of the inner catheter assembly 78 so as to resist axial translation of the inner catheter assembly 78 relative to the actuator assembly 12 without causing permanent deformation or damage to the inner catheter assembly 78, and is configured to intrude into the nominal profile of the inner lumen 32 of the extension housing 22. It may include a pivot lever 218 having an offset cam 222. Additionally, the offset cam 222 of the pivot lever 218 may also be configured to clear the nominal profile of the inner lumen 32 when arranged in a released position so as to allow relative axial translation between the inner catheter assembly 78 and the actuator assembly 12.

[0086] Some embodiments of the inner catheter assembly position locking portion may also include a collet type inner catheter assembly position locking portion 212’ as shown in FIG. 8. For such an embodiment 212’, a threaded cap 219 is sized to allow passage of the extension shaft 82 of the inner catheter assembly 78 when the threaded cap 219 is relaxed, but to crimp onto the outer surface 214 of the inner catheter assembly 78 when the threaded cap 219 is tightened, and may include a tapered bore 220 that engages the outer end of a flexible slotted sleeve 221 having an inner lumen disposed therethrough.

[0087] When determining the relative axial position between the inner catheter assembly 78 and the actuator assembly 12, it may be useful for each of these structures to have a predetermined reference point that is easily distinguishable by the user. For example, in some cases, the extension shaft 82 may include an insertion alignment mark 224 disposed on its outer surface 214 that is visually distinguishable by the user as shown in FIG. 2. The actuator assembly 12 may include a cooperating proximal index 226 that is visually distinguishable by the user as shown in FIG. 7. For such embodiments, the axial position of the deployed foot-like extension 166, more specifically, the axial position of the “v”-shaped notch formed between the deployed foot-like extension 166 and the extension shaft 82 on the proximal side of the deployed foot-like extension 166 in the deployed state (see FIGS. 39, 41, and 45) may be separated from the distal end 28 of the extension housing 22 by a predetermined axial separation when the insertion alignment mark 224 is axially aligned with the proximal index 226. In some cases, the proximal index 226 and the insertion alignment mark 224 may be axially positioned on their respective structures such that the predetermined axial separation may be from about 260 mm to about 285 mm, more specifically, from about 270 mm to about 275 mm.

[0088] In some cases, the extension shaft 82 may further include a retraction alignment mark 228 disposed on its outer surface 214 that is visually distinguishable by a user, as shown in FIG. 2. For some such embodiments, when the retraction alignment mark 228 is axially aligned with the proximal index 226, this alignment may be used to indicate the relative axial relationship, and the distal end 86 of the extension shaft 82 of the inner catheter assembly 78 is disposed within the inner lumen 32 of the extension housing 22. This arrangement can be useful when it is important to determine that the distal end 86 of the extension shaft 82 of the inner catheter assembly 78 is no longer disposed within the passage 216 adjacent to the access hole 124 within the blood vessel 128. In some cases, it may be desirable for the insertion alignment mark 224 and the retraction alignment mark 228 to be visually distinct from each other. In some cases, the insertion alignment mark 224 may be a single band of color that is different from the color of the outer surface 214 of the extension shaft 82, and the retraction alignment mark 228 may be a double band of the same or different color as that of the insertion alignment mark 226.

[0089] Prior to deployment of the anchor deployer 52, in order to ensure proper angular alignment of the actuator assembly 12, in some instances it may be useful to include an angular alignment mechanism 232 as part of the blood vessel occlusion assembly 10, as shown in FIG. 5. In some instances, the actuator assembly 12 of the blood vessel occlusion assembly 10 includes a boss 234 extending from the chassis portion 12 and a substantially shallowly configured conical cavity 236 disposed within the boss 234 having a symmetry axis 238 that forms a predetermined angle 242 with the longitudinal axis 244 of the extension housing 22. The conical cavity 236 may include a predetermined conical angle 246 defined between a plane perpendicular to the inner surface 252 of the conical cavity and the symmetry axis 238. The predetermined conical angle 246 may be configured to determine the sensitivity of the angular alignment mechanism 232, with a smaller conical angle 246 being more sensitive to angular variations and a larger conical angle 246 being less sensitive to angular variations.

[0090] A ball bearing 248 or a similar spherical structure may be disposed within the conical cavity 236. The ball bearing 248 rotates freely on the inner surface 252 of the conical cavity 236 and may be sized such that the axis of symmetry 238 remains centered on the axis of symmetry 238 as long as the axis of symmetry 238 deviates from an angular position that is horizontal and vertical by an angle greater than the conical angle 246 of the conical cavity 236. In other words, when the angular orientation of the angle alignment mechanism 232 is correct, the ball bearing 248 seats at the center of the conical cavity 236 as shown in FIG. 5. If the alignment is incorrect, gravity causes the ball bearing 248 to roll away from the center of the conical cavity 236 due to the tapered bottom surface 252 of the conical cavity 236. Although referred to herein as a conical cavity 236, any other suitably configured cavity such as a spherical cavity, a parabolic cavity, or the like may also be used. Additionally, with respect to the embodiment shown, the axis of symmetry 238 and the longitudinal axis 244 are substantially in the same plane.

[0091] The angle alignment mechanism 232 may include a window 254 that is disposed across the conical cavity 236 and prevents escape of the ball bearing 248 while still allowing its visualization. Embodiments of the angle alignment mechanism 232 may be specifically designed to be compatible with various sterilization methods such as electron beams and ethylene oxide (EtO) (some of which may not be suitable for conventional level alignment fixtures). For some embodiments, the conical angle 246 may be from about 5 degrees to about 10 degrees. Additionally, the predetermined angle 242 formed between the axis of symmetry of the conical cavity and the longitudinal axis of the elongated housing may be from about 15 degrees to about 25 degrees.

[0092] Once the actuator assembly 12 and its extension housing 22 are properly positioned, the deployment of the plurality of anchor deployers 52 may be performed by various mechanisms and methods including an anchor deployer actuator 256, as shown in FIGS. 3, 12, and 13. For some embodiments, the anchor deployer actuator 256 of the vascular occlusion assembly 10 may include an anchor deployer carrier 258, which is slidably disposed relative to the chassis portion 14 and operably coupled to the proximal segment 262 of each of the plurality of deployer rods 56, as shown in FIG. 13. An actuator lever 264 may extend outside of the chassis portion 14 of the outer shell 16 and be operably coupled to the anchor deployer carrier 258 to translate the anchor deployer carrier 258 distally in a parallel motion in response to an actuating translation. Such an axial translation of the anchor deployer carrier 258 from its starting position, where the anchors 62 of the anchor deployers 52 are substantially disposed within the nominal outer surface profile 266 of the extension housing 22, will axially translate each of the deployer rods 56 and associated anchors 62 distally and radially outwardly from the extension housing 22 in response to the actuating translation, as shown in FIG. 12. In some cases, the actuator lever may be manually operated such that a manually applied compression applied over the actuator lever 264 is converted into an axial translation of the anchor deployer carrier 258 in the distal direction. A return spring 268, operably coupled between the actuator lever 264 and the chassis portion 14, may resist the manually applied actuating translation of the actuator lever 264 and / or the anchor deployer carrier 258 and be configured to return the actuator lever 264 and the anchor deployment carrier 258 from their displaced positions to their starting positions.

[0093] The anchor deployer actuator 256 discussed above uses manual compression of the actuator lever 264 to provide a distally-directed force on the deployer rod 56 through the anchor deployer carrier 258. However, any number of other suitable devices and methods may be used to provide a distally-directed force and deploy the anchor deployer 52. In some cases, a compressed spring, such as the deployment spring 275, included within the anchor deployer actuator 256' may be used to provide the distally-directed force used to deploy the anchor deployer 52, as shown in FIG. 12A. With respect to the deployer actuator embodiment 256' shown in FIG. 12A, the anchor deployer carrier 258' may be operably coupled to the proximal segments 262 of the deployment spring 275 and the deployer rod 56, respectively. The actuator lever 264' is configured to be operably coupled to the anchor deployer carrier 258' so as to maintain the deployment spring 275 in a compressed state until the operator is ready to deploy the anchor deployer 52. Once depressed or otherwise actuated, the actuator lever 264' allows the deployment spring 275 to be released from its axially compressed state, as discussed above with respect to other embodiments included herein, and the compressed spring force of the deployment spring 275 then provides an axially distally-directed force on the deployer rod 56, thereby releasing the anchor deployer carrier 258' to advance the anchor deployer 52 from the distal segment 34 of the elongate housing 22 in a distal and radially outward direction.

[0094] Referring to FIGS. 19-21, in some cases, each distal segment 45 of the anchor deployer lumen 42 is configured such that when the anchor deployer 52 translates distally and extends outwardly from or otherwise is disposed within and extends from the distal port 44 of the anchor deployer lumen 42, an outward angular deflection of the anchor deployer 52 is provided. In some cases, each distal segment 45 of the anchor deployer lumen 42 may include a curved profile 270 relative to the longitudinal axis 272 of the nominal anchor deployer lumen segment 274 disposed proximal to the distal segment 45 of the anchor deployer lumen 42. The curved profile 270 may be configured to provide an outward angular deflection of the anchor deployer 52 when the anchor deployer 52 translates distally and extends outwardly from the distal port 44 of the anchor deployer lumen 42, as described above. In some cases, such a curved profile 270 may form a helical profile relative to the distal segment 34 of the elongate housing 22.

[0095] Regarding quantification of the outward angular deflection of the anchor deployer 52, the launch axis 276 is an axis defined by the longitudinal axis of that portion of the deployment rod 56 extending from the distal port 44 of the anchor deployer lumen 42. In some cases, each distal segment 45 of the anchor deployer lumen 42 is configured to provide an outward angular deflection of the anchor deployer 52 having a launch axis 276 that forms an angle 278 of from about 15 degrees to about 35 degrees relative to the longitudinal axis 272 of the nominal anchor deployer lumen segment 274 disposed proximal to the distal segment 45 of the anchor deployer lumen 42 and / or the longitudinal axis 244 of the elongate housing 22. For some embodiments, the curved profile 270 of each distal segment 45 of the anchor deployer lumen 42 may be configured to produce such a range of the launch axis 276 and associated angle 278 as described above. For some embodiments, each distal segment 45 of the anchor deployer lumen 42 may be configured to provide an outward angular deflection of the anchor deployer 52 without using a curved profile. For example, a contact, deflection block, or other suitable structure (not shown) configured to deflect the anchor deployer 52 may be disposed within the distal segment 45 of the anchor deployer lumen 42 that does not have a curved profile and otherwise has a linear shape.

[0096] In addition, each distal segment 45 of the anchor deployer lumen 42 may have a recessed pocket 282 with an inner contour 284 configured to receive the outer contour of an individual anchor 62 disposed therein with a snug fit therebetween. In such a case, the snug fit between the inner contour 284 of the recessed pocket 282 and the outer contour of the individual anchor 62 may include a snap fit or a tight sliding fit, and the anchor 62 is held in place within the individual recessed pocket 282 by a lateral force generated by the distal end 58 of the deployer rod 56 that is resiliently bent into a deflected configuration by its curved contour and curvature. This snap fit or tight fit may be configured to hold the anchor 62 in place until the anchor deployer 52 is deployed by the anchor deployer actuator 256.

[0097] Referring to FIG. 20, the distal segment 34 of the elongate housing 22 is shown disposed above and adjacent to the tissue layer 64 with the longitudinal axis 244 of the elongate housing 22 aligned with the center of the passage 216 within the tissue layer and the access hole 124 of the blood vessel 128. In some cases, with respect to such an arrangement, the longitudinal axis 192 of the elongating shaft 82 of the inner catheter assembly 78 (the inner catheter assembly 78 is not shown in FIG. 20 for purposes of illustration clarity) may also be so aligned. The deployed anchor deployer 52 shown in FIG. 20 illustrates an asymmetric deployment pattern that may be useful in certain situations.

[0098] For such embodiments, the deployment pattern for the anchors 62 of the plurality of anchor deployers 52 may be an asymmetric deployment pattern. In some cases, for such an asymmetric deployment pattern, the anchor piercing sites may be disposed within the tissue layer 64 at the corners of a generally square or rectangular pattern 243 (or any other suitable pattern) in the plane of the tissue layer 64. However, the axis of symmetry 245 of such a deployment pattern 243 is such that, as shown in FIGS. 20 and 20A, the piercing sites within the tissue layer 64 for the anchor deployers 52 on one side of the elongate housing 22 are further from the longitudinal axis 244 of the elongate housing 22, the longitudinal axis 192 of the elongate shaft 82, and / or the center of the passage 216 than the piercing sites of the anchor deployers on the other side of the elongate housing 22, and may in fact be offset laterally or in any other suitable direction. FIG. 20A schematically shows, in particular, how the axis of symmetry 245 of the rectangular deployment pattern 243 is offset laterally to the right from the longitudinal axes 192, 244 of the elongate shaft 82 and the elongate housing 22, as indicated by the distance shown between the axis of symmetry 245 and the axes 192, 244. The desired amount or distance of such lateral offset (or offset in any other direction) may depend on various factors, including certain clinical factors and morphological structures. In some cases, the distance of the offset may be equal to or greater than one half of the lateral width measurement of a target vessel such as the artery 128. The distance of the offset may also be up to the distance of separation of the longitudinal axis 406 of the target vessel 128 and the longitudinal axes of adjacent vessels such as the vein 130, as shown in FIG. 20. For some embodiments, the distance of the offset of the deployment pattern 243 from the axis 192 or 244 may be from about 3 mm to about 15 mm, more specifically from about 5 mm to about 10 mm. Such an asymmetric deployment pattern may include any other desired deployment pattern 243 other than the piercing sites at the corners of the square or rectangular pattern that provides the desired clinical result.

[0099] In some cases, the asymmetric deployment pattern 243 of the anchor deployer 52 may be wider on the side of the target vessel 128 that includes another vascular structure to be avoided and narrower on the side of the target vessel 128 that does not include such a structure. For example, if the target vessel 128 is the femoral artery, the deployment pattern may be wider on the side of the elongate housing 22 corresponding to the location of the associated vein 130 (to be avoided by the anchor deployer) as shown in FIG. 20 and narrower on the side of the elongate housing facing the associated vein 130.

[0100] For some embodiments, as discussed above, to produce the asymmetric deployment pattern 243, the curved profile 270 of the distal section 45 of the first anchor deployer lumen 42 of the actuator assembly 12 may include a firing axis 276 that forms a first angle 278 with respect to the longitudinal axis 272 of the nominal anchor deployer lumen section 274 disposed proximal to the distal section 45 of the anchor deployer lumen 42. Additionally, the curved profile 270' of the distal section 45' of a second anchor deployer lumen 42' (not shown) of the same actuator assembly 12 may include a firing axis 276' that forms a second angle 278' with respect to the longitudinal axis 272' of a nominal anchor deployer lumen section 274' (not shown) disposed proximal to the distal section 45' of the second anchor deployer lumen 42', and the second angle 278' may be different from the first angle 278 as shown in the asymmetric deployment pattern of FIG. 20. Such an arrangement, where the axial positions of the individual distal ports 44, 44' with respect to the elongate housing 22 are the same but the firing axes 276 of the distal ports 44, 44' vary, may be used to produce an asymmetric deployment pattern as shown.

[0101] However, the overall configuration of the anchor deployer lumen 42 and the individual distal ports 44 may be selected in other ways to produce the same or any other desired deployment pattern, which may be symmetric or asymmetric. For example, to achieve the same or a similar asymmetric deployment pattern as shown in FIGS. 20 and 20A, the angles 278 of the respective launch axes 276 of the deployer lumens 42 may be the same. However, the axial position of the distal ports 44 on one side (the side of the vein 130) may be disposed proximally further from the distal end 28 of the elongate housing 22 than the distal ports 44 on the side facing the vein 130. That is, the respective axial positions and launch axes 276 of the anchor deployer lumens may be configured in any suitable manner to produce the desired deployment pattern and the desired offset from the longitudinal axis 244 of the elongate housing 22 and / or the longitudinal axis 192 of the elongate shaft 82.

[0102] Referring to FIGS. 29 and 30, any number of configurations of the anchor embodiment 62 and the deployment rod embodiment 56 may be used for the plurality of anchor deployers 52 that provide a useful and reliable mooring function. In some cases, an embodiment of the anchor 62 may include a sharp distal tip 286, such as a trocar tip, which is configured to penetrate the tissue 64 in the distal direction. Such an anchor embodiment 62 may also include a tab 288 at the proximal end 290 of the anchor 62 that can be raised or otherwise deflected radially outward. The tab 288 engages the tissue 64 and, once deployed into the tissue, may be configured to create a feature that assists in preventing separation of the anchor 62 from the distal end 58 of the deployment rod 56 during retraction of the deployment rod 56 from the anchor embodiment 62 by resisting retrograde translation of the anchor 62. Such an anchor embodiment 62, including its proximal tubular portion, may be releasably disposed on the distal end 58 of an individual deployment rod 56. For such an embodiment, the distal tip 58 of the deployment rod 56 may have any suitable shape, such as flat, blunt, or the like, and need not be sharp so that the distal tip 58 does not directly interact with the tissue 64 in response to distal extension and actuation. Each anchor embodiment 62 may further be secured to the distal end 68 of a filament 66, which is used to apply a radially inward tension to each of the anchors 62 once they are deployed into the target tissue of the tissue layer 64. The anchor 62 having the sharp distal tip 286 may be made of any suitable rigid high-strength material configured for tissue penetration and mooring. In some cases, such an anchor embodiment 62 may be made of a metal such as stainless steel, a nickel-titanium alloy, or the like, which may, in some cases, be non-bioabsorbable. In some cases, such an anchor may also include a bioabsorbable material.

[0103] In other embodiments, each anchor deployer 52 of the plurality of anchor deployers 52 may include a deployment rod 56' having a sharp tissue piercing tip 294 disposed on the 'distal end 58' of the deployment rod 56, as shown in FIG. 30. For such embodiments, the individual anchors 62' are removably secured to the distal end 58' of the deployment rod 56', may have a tubular configuration, and may not be accompanied by a sharp distal tip 286. Such a deployment rod embodiment 62' may further include an anchor receiving surface 296 disposed proximal to the sharp tissue piercing tip 294, which has an outer surface contour 298 configured to engage the inner surface contour of the inner lumen 302 of the tubular configuration of the anchor embodiment 62'. Additionally, the deployment rod embodiment 56' may further include a shoulder 304 having a stop surface 306 disposed distally and proximal to the proximal end 308 of the anchor receiving surface 296. In such cases, the stop surface 306 may extend radially outwardly from the anchor receiving surface 296 and may function to fix the axial position of the anchor 62' on the anchor receiving surface 296 during tissue penetration.

[0104] Such an anchor embodiment 62' may further include a filament attachment feature or loop 312 disposed on the outer surface 314 of the anchor 62' or at any other suitable location, which has a filament hole 316 or other suitable feature configured to be secured to the distal end 68 of a filament 66 such as a suture. In some cases, the filament hole 316 may be secured to the distal end 68 of the filament 66 by squeezing or crimping the loop material of the filament attachment feature 312 onto the distal segment 68 of the filament 66. Such a filament attachment feature 312 may also be used on any other anchor embodiment 62 discussed herein, including those anchor embodiments having a sharp distal tip 286.

[0105] The anchor embodiment 62' without a sharp distal tip 286 may be made of any suitable rigid, high-strength material configured for tethering. In some cases, such an anchor embodiment 62' may be made of a metal such as stainless steel, nitinol alloy, or the like, which may, in some cases, be non-bioabsorbable. In some cases, such an anchor embodiment 62' may also include a bioabsorbable material.

[0106] Some anchor deployer embodiments 52 may include an anchor 62'', which may each be secured to an elongate and flexible filament 66 and configured to be driven distally from the distal end 322 of the inner lumen 326 of a hollow deployment needle 324. For such embodiments, the hollow deployment needle 324 has a sharp distal tip 328 and may be configured to penetrate tissue 64 upon deployment such that the anchor 62'' disposed therein does not require any tissue-penetrating characteristics. Thus, the anchor embodiment 62'' may have various configurations, as discussed above, due to serving a single purpose, namely, tethering only, once deployed into the target tissue 64, without the need for features such as being sharp for tissue penetration or including tabs 288 to resist proximal extraction within the tissue 64 and facilitate removal from the deployment rod 56. The hollow deployment needle 324 has its proximal end secured to a carrier such as the anchor deployer carrier 258, replacing the deployment rod 56, and may function in the same or a similar manner as the anchor deployer actuator 256 discussed herein.

[0107] These anchor embodiments 62’’ may be deployed from the distal end 322 of the inner lumen 326 of the hollow deployment needle 324 by distal translation of a pusher rod 332 disposed within the inner lumen 326 of the proximal hollow deployment needle 324. The pusher rod embodiment 332 may have a flexible configuration and be disposed within and along the inner lumen 326 of the hollow deployment needle 324. The pusher rod 332 may be advanced and deployed distally by any suitable means, including an actuator (not shown) that is similar or identical to the anchor deployer actuator embodiment 256 shown and discussed herein, to deploy the anchor 62’’ from the distal end 322. With respect to such embodiments, the proximal end or segment of the pusher rod 332 may be operably coupled to a carrier such as the anchor deployer carrier 258 and associated structures. Some hollow deployment needle embodiments 324 may include a slotted tube of a highly elastic material, such as a slotted hypodermic tube made of stainless steel, nitinol, or the like, including lateral slots 325 disposed through the wall of the deployment needle 324. The anchor embodiments 62’’ may include a rigid or compliant biocompatible material such as stainless steel, nitinol, PTFE fluff, bioabsorbable polymers, and non-bioabsorbable polymers. In some cases, the anchor 62’’ may be configured to expand after deployment from the distal end 322 of the inner lumen 326 of the hollow deployment needle 324.

[0108] The actuator assembly 12 of the vascular occlusion assembly 10 may also include a filament tensioning mechanism 336, which is configured to controllably apply axial tension to the filaments 66 of the individual anchor deployers 52 to pull the filaments 66 back into the elongate housing 22 and to pull the anchors 62 deployed in the tissue layer 64 closer together. In some cases, the filament tensioning mechanism 336 may include a filament end 338 that is secured to the proximal ends of the filaments 66 of the plurality of anchor deployers 52, and a tensioning spring 342 that is operably secured to the filament end 338. The filament end 338 may be translatable from a first position where there is no tension applied to the filament 66 by the filament end 338 to a second position where tension is applied to the filament 66 through the filament end 338 by the tensioning spring 342.

[0109] Regarding some embodiments, the filament tensioning mechanism 336 is disposed on the chassis portion 14 and may further include a threaded rod 344, which is rotatable about its longitudinal axis 346 but is configured to be axially fixed relative to the chassis portion 14. The filament tensioning mechanism 336 may also include a tension control block 348 having a threaded bore 352 operatively coupled to the threaded rod 344. Regarding such embodiments, the tension control block 348 is rotatably fixed, but the rotation of the threaded rod 344 relative to the chassis portion 14 and the tension control block 348 may be axially translatable relative to the chassis portion 14 such that the tension control block 348 is axially translated relative to the chassis portion 14. Additionally, a tension transfer clip 354 may be used to releasably couple the filament end 338 to the tension control block 348 in an orientation that opposes the tension of the tensioning spring 342 to controllably apply the tension of the tensioning spring 342 to the filament 66 through the filament end 338. The filament tensioning mechanism 336 may also have a knob 356 secured to the outer end 358 of the threaded rod 344 to provide a comfortable grip for the user to apply a rotational force to the threaded rod 344.

[0110] Regarding this configuration, at the start of the procedure, prior to activation of the knob 356, the tension control block 348 is disposed at an upper axial position along the threaded rod 344, and the entire tension of the bridging spring 342 is transmitted through the tension transmission clip 354 to the tension control block 348 and thereby counteracted in a state where the tension is not applied to the filament 66. As the knob 356 is rotated and the tension control block 348 translates downward in parallel, the counterforce against the tension generated by the bridging spring 342 is reduced with respect to the tension control block 348 because any slack within the filament 66 is removed and that tension begins to be applied to the filament 66. As the knob 356 is further rotated and the tension control block 348 further translates downward in parallel, an increasing amount of tension is transmitted from the tension control block 348 onto the filament 66 through the filament end 338. Eventually, all of the tension from the bridging spring 342 is transmitted to the filament 66, and the tension transmission clip 354 is completely decoupled from the tension control block 348 as shown in FIG. 57 and discussed below. Such a configuration is very useful for controllably applying a consistent and reproducible tension to the filament 66, particularly when the bridging spring 342 is a constant force type spring that does not vary significantly in bridging tension as a function of small displacements of the ends of the bridging spring 342 as in the illustrated embodiment.

[0111] Once the anchor 62 is deployed by the anchor deployer 52 to reduce or close the passageway within the tissue layer 64, it may be useful to fix the filament 66 in a retracted configuration when the filament 66 is retracted. Some embodiments of the actuator assembly 12 of the vascular occlusion assembly 10 may include a filament locking mechanism 72, as shown in FIGS. 3, 21-23, and 59-60. Embodiments of the filament locking mechanism 72 may include a filament tube 37 having a distal section 40 that is slidably disposed within a snug bore 362 in the distal section 34 of the elongate housing 22. The filament tube 37 may also have a distal end 364 that extends distally beyond the distal shoulder surface 366 of the snug bore 362. The filament tube 37 is axially slidable relative to the elongate housing 22 and the distal shoulder surface 366 and may include an inner filament lumen 36 that is centered about the filament 66. The filament tube 37 may further include a proximal section 368, as shown in FIG. 22.

[0112] The filament locking mechanism 72 may also include a filament locking portion 76 (or a plurality of filament locking portions 76), which has an inner lumen 370 that is disposed about the distal end 364 of the filament tube 37 at the distal axial position of the distal shoulder surface 366 of the press fit bore 362. Embodiments of the filament locking portion 76 are configured to self - contract from an expanded state to a relaxed state and, once the outward radial support that produces the expanded state of the filament tube 37 is removed, are configured to crimp onto the filament 66 that is disposed within the filament lumen 36 of the filament tube 37. In some embodiments, the filament guide 372 may also be disposed on the distal end 364 of the filament tube 37 to provide a smoothly rounded transition for the tensioned filament 66 to be fed into the distal port 38 of the filament lumen 36 of the filament tube 37, preventing wear or other damage to the filament 66 at this location where they may, in some cases, undergo a right - angle bend at a small radius. The filament locking portion bushing 373 may also be disposed on the filament tube 37 at the distal side of the proximal and distal shoulder surfaces 366 of the filament locking portion 76. The filament locking portion bushing 373 may have an inner lumen that is similar to that of the press fit bore 362 but is slidably disposed to fit with the outer surface of the filament tube 37 in proximity thereto.

[0113] The filament locking mechanism 72 may further include a filament tube actuator 374, which is operably coupled to the proximal section 368 of the filament tube 37, and is configured to axially retract the filament tube 37 in the proximal direction relative to the distal shoulder surface 366 in response to activation, so as to push the filament locking part 76 away from the distal end 364 of the filament tube 37 and enable the filament locking part 76 to crimp onto the filament 66 disposed within the filament lumen 36 of the filament tube 37. Some embodiments of the filament locking mechanism 72 may have a plurality of filament locking parts 76 that are axially arranged adjacent to each other on the distal end 364 of the filament tube 37 at the distal axial position of the distal shoulder surface 366 of the press fit bore 362. In some cases, the filament tube 37 may have a rigid tubular structure made of a high-strength material. In some cases, the high-strength material of the filament tube 37 may include stainless steel.

[0114] Some embodiments of the filament locking portion 76 may include a "trailing edge locking" type configuration in which, as shown in FIGS. 21 - 24, the tubular structure includes a main body portion 378 and a plurality of finger portions 382 extending proximally from the main body portion 378. In some cases, the finger portions 382 are of sufficient axial length such that the individual distal ends 386 of the finger portions 382 are configured to self - contract in a direction oriented radially inwardly and are elastically biased toward the central longitudinal axis 384 of the main body portion 378. The finger portions 382 may self - contract from an expanded state to a relaxed state so as to crimp onto the filament 66 disposed within the inner lumen 370 of the filament locking portion 76 when the finger portions 382 are in the relaxed state. In the contracted state, the inner surface of the distal end 386 of the finger portion 382 may form a residual lumen 383 in the absence of any filament disposed therein. Additionally, these finger embodiments 382 may be elastically diffused radially outwardly for relative lateral separation to generate an expanded state that may be sufficient to fit onto the outer surface of the distal end 364 of the filament tube embodiment 37. With respect to the filament locking portion embodiment 76 shown, the finger portions 382 have a generally triangular shape, and the base portion is disposed adjacent to the proximal end of the main body portion 378, opposite the distal end 386 and wider than its individual distal end 386.

[0115] For some embodiments, the axial length of the main body portion 378 may be the same as or similar to the axial length of the finger portions 382. For such embodiments, the overall axial length of the filament locking portion embodiment 76 may be from about 0.06 inches to about 0.1 inches, more specifically, from about 0.075 inches to about 0.085 inches. Such a filament locking portion embodiment may have an inner lumen 370 with an inner diameter from about 0.04 inches to about 0.06 inches, more specifically, from about 0.045 inches to about 0.055 inches. The same embodiment may, in some cases, have a wall thickness of the tubular structure of the main body portion 378 and the finger portions 382 from about 0.013 inches to about 0.023 inches, more specifically, from about 0.016 inches to about 0.020 inches. For some embodiments, the ratio of the axial length of the finger portions 382 to the inner diameter of the inner lumen 370 may be from about 0.6 to about 1.5. In some cases, in the absence of any filament 66 disposed therein, the residual lumen formed by the distal end 386 of the finger portions 382 in the relaxed state may have a lateral dimension from about 0.010 inches to about 0.015 inches, and the ratio of such a residual lumen to the inner lateral dimension of the inner lumen 370 may be from about 0.1 to about 0.7. For some embodiments, the ratio of the wall thickness of the tubular structure of the main body portion 378 to the outer diameter of the tubular structure of the main body portion 378 may be from about 0.05 to about 0.25. For the filament locking portion embodiment 76 shown, the finger portions 382 are substantially uniformly spaced about the circumference of the main body portion 378, however, any suitable circumferential spacing may be used. In some instances, embodiments of the filament locking portion 76 may have from about 3 finger portions 382 to about 10 finger portions 382, more specifically, from about 4 finger portions 382 to about 6 finger portions 382. Some embodiments of such a filament locking portion 76 may be made of, or include, a highly elastic material, including a superelastic material. Such a superelastic material may include a superelastic polymer or a superelastic metal alloy such as a nickel-titanium alloy or the like.

[0116] Some embodiments of the filament locking portion 76' may include a coiled spring filament 376, and the inner lumen 370 of the filament locking portion 76' is sized to crimp onto a filament 66 disposed therein when in a contracted state, as shown in FIGS. 25 - 28. In some such embodiments, the coiled spring filament 376 may have a non-rounded transverse cross-sectional outer shape. For example, in some cases, the transverse cross-sectional outer shape of the coiled spring filament may have a rectangular or diamond-shaped outer shape such that the sharp edges of such an outer shape can be used to bite into the outer surface of the filament 66 to provide an effective lock therebetween. In some instances, such an arrangement may provide a more secure lock between the filaments than can be provided by a coiled spring filament 376 having a rounded or substantially rounded transverse cross-sectional outer shape. With respect to such embodiments, the inner lumen 370 may be elastically expanded to a sufficient transverse dimension to fit onto the outer surface of the distal end 364 of the filament tube 37, as shown in FIG. 28.

[0117] Once the retracted filaments 66 of the vascular occlusion assembly 10 are locked in a fixed position relative to each other, it may be useful to cut the filaments 66 at a position proximal to the filament locking portion 76. Thus, some embodiments of the actuator assembly 12 may further include a filament cutter 390 disposed in an operable array with the filaments 66 of the plurality of individual anchor deployers 52, as shown in FIGS. 12, 17, and 18. In some cases, the filament embodiment 66 may include a suture, and the filament cutter 390 may include a suture cutter including a sharp blade 392 disposed within a sliding portion 394 that is angled toward the suture 66 and configured to translate laterally within a bore 396 parallel to the suture 66. For such embodiments, the blade 392 may approach the suture 66 during lateral translation of the blade 392 such that the sharp edge 398 of the blade 392 contacts the suture 66 and cuts through the suture 66 prior to the end of the corresponding lateral actuation stroke. In some cases, the suture cutter 390 may be disposed on the chassis portion 14 of the actuator assembly 12.

[0118] In use, embodiments of the vascular occlusion assembly 10 may be used to reduce or eliminate the size of the passage 216 in the tissue layer 64 disposed above and adjacent to the access hole 124 in the blood vessel 128 so as to provide hemostasis with respect to the access hole 124 in the blood vessel 128 after a minimally invasive vascular procedure or the like. Such devices and techniques discussed herein for providing such hemostasis may do so indirectly, without directly closing the access hole 124 in the blood vessel 128 or suturing or otherwise penetrating the wall portion 126 of the blood vessel 128 during the hemostasis process. This may be useful, particularly in situations where the wall portion 126 of the blood vessel 128 is affected or otherwise impaired by the presence of calcified plaque as well as many other situations.

[0119] Some embodiments of the method for vascular occlusion may include advancing the vascular occlusion assembly 10 distally over the exposed proximal portion 402 of the guidewire 117 such that its distal segment 404 is disposed through the access hole 124 in the patient's blood vessel 128 and through the passageway 216 in the tissue layer 64 disposed above and adjacent to the access hole 124. The guidewire 117 is also disposed through the patient's skin layer 125 and the tissue disposed between the patient's skin 125 and the tissue layer 64. The method may further include advancing the vascular occlusion assembly 10 distally over the guidewire 117 while the inner catheter assembly 78 of the vascular occlusion assembly 10 is disposed within the inner lumen 32 of the extension housing 22 of the actuator assembly 12 of the vascular occlusion assembly 10.

[0120] In some cases, the vascular occlusion assembly 10 may be advanced such that the self-expanding balloon 94 of the inner catheter assembly 78 extends distally beyond the distal end 28 of the extension housing 22 and the inner catheter assembly 78 is releasably secured to the actuator assembly 12 by the inner catheter assembly position lock 212 to prevent relative axial displacement therebetween. Additionally, the step of advancing the vascular occlusion assembly 10 over the guidewire 117 may, in some cases, include advancing distally the guidewire lumen 114 of the extension shaft 82 of the inner catheter assembly 78 of the vascular occlusion assembly 10 over the guidewire 117.

[0121] Regarding some embodiments, the vascular occlusion assembly 10 may continue to be advanced, as shown in FIG. 50, until blood is observed being discharged from the proximal port 122 of the blood return lumen 118 of the inner catheter assembly 78. Discharge of blood 123 from the proximal port 122 indicates that the distal port 120 of the blood return lumen 118 is disposed within the inner lumen 150 of the patient's blood vessel 128 and is suitably positioned for deployment of the foot-like extension 166. Typically, the distal section 34 of the elongate housing 22 is also disposed at or below the patient's outer skin layer 125 at this stage.

[0122] The method thus includes the step of deploying the foot-like extension 166 from the elongate shaft 82 of the inner catheter assembly 78. In some instances, the foot-like extension 166 is deployed from a position within the internal volume 98 of the self-expanding balloon 94, as shown in FIGS. 39 and 50. In this case, the foot-like extension 166 is disposed along the elongate shaft 82 within the internal volume 98 of the self-expanding balloon 94 such that as the foot-like extension 166 extends radially outwardly from the elongate shaft 82, it may radially outwardly push a portion of the wall 96 of the self-expanding balloon 94. However, the wall 96 of the self-expanding balloon 94 may be thin and flexible enough to conform to the outer contour of the foot-like extension 166 and be configured not to interfere with the function of the foot-like extension 166. As discussed above, in some cases, the foot-like extension 166 may be axially disposed such that it is coextensive with the self-expanding balloon 94 but not within the internal volume 98. For such embodiments, the foot-like extension 166 may be deployed from a position outside the internal volume 98.

[0123] Once the foot-like extension 166 is deployed, the vascular occlusion assembly 10 may be retracted proximally until contact or other mechanical interaction or abutment between the foot-like extension 166 and the inner surface 152 of the inner lumen 150 of the patient's blood vessel 128 adjacent to the access hole 124 prevents further proximal displacement of the inner catheter assembly 78, as shown in FIG. 50A. In this configuration, generally, the axial portion of the self-expanding balloon 94 overlaps the access hole 124. Additionally, it should be noted that in this configuration where the foot-like extension 166 is deployed and the vascular occlusion assembly 10 (or only the inner catheter assembly 78 if the inner catheter assembly 78 is not releasably fixed to the actuator assembly 12 at will) is in a state of preventing further proximal retraction, even when the surfaces mechanically face each other, the layer of the wall 96 of the self-expanding balloon 94 will be disposed between the outer surface of the foot-like extension 166 and the inner surface 152 of the blood vessel 128.

[0124] Once the self-expanding balloon 94 and the foot-like extension 166 disposed therein are axially fixed in place, the balloon inflation valve 112 of the inner catheter assembly 78 may be opened using the balloon inflation lever 148, as shown in FIGS. 36 and 37, allowing pressurized blood to flow from within the internal volume 150 of the patient's blood vessel 128 through the balloon inflation lumen 102 of the inner catheter assembly 78 into the internal volume 98 of the self-expanding balloon 94. The self-expanding balloon 94 may continue to be allowed to expand until contact and hemostasis are established between the outer surface 154 of the self-expanding balloon 94 and the surrounding surface 156 of the access hole 124 within the blood vessel 128, as shown in FIG. 51.

[0125] The inner catheter assembly 78 may then be released from the actuator assembly 12 by releasing the inner catheter assembly position locking portion 212 and enabling the inner catheter assembly 78 to translate axially parallel to the actuator assembly 12. The actuator assembly 12 is then advanced distally over the inner catheter assembly 78 while holding the inner catheter assembly 78 in an axially fixed position relative to the access hole 124 in the blood vessel 128 until the distal end 28 of the extension housing 22 of the actuator assembly 12 is positioned adjacent to the passage 216 in the tissue layer 64, as shown in FIG. 52. In some cases, the actuator assembly 12 may be advanced distally over the inner catheter assembly 78 until the proximal index 226 of the actuator assembly 12 is aligned with the insertion alignment mark 224, which is positioned on the inner catheter assembly 78.

[0126] This technique may be useful for a variety of patients having a variety of tissue morphological structures in terms of the area of the passage 216 and the access hole 124 in the tissue layer 64. Generally, the distance between the tissue layer 64 (e.g., fascia layer, etc.) and the blood vessel wall 126 (e.g., the blood vessel wall 126 of the femoral artery, etc.) is reasonably consistent for each patient, even though it may vary significantly from patient to patient depending on the distance between the outer surface of the patient's skin and the fascia layer 64.

[0127] In some cases, once in a fixed position, the inner catheter assembly 78 may then be releasably secured to the actuator assembly 12 by activating the inner catheter assembly position lock 212. In some instances, also at this point, as shown in FIG. 52, it may be useful to orient the longitudinal axis 244 of the elongate housing 22 relative to the longitudinal axis 406 of the patient's blood vessel 128, as indicated by arrow 407. The step of orienting the longitudinal axis 244 of the elongate housing 22 relative to the longitudinal axis 406 of the patient's blood vessel 128 may include the step of forming an angle of about 50 degrees to about 80 degrees between the longitudinal axis 244 of the elongate housing 22 and the longitudinal axis 406 of the blood vessel 128. The step of orienting the longitudinal axis 244 of the elongate housing 22 relative to the longitudinal axis 406 of the patient's blood vessel 128 may also include observing the angle alignment mechanism 232 and adjusting the angle between the longitudinal axis 244 of the elongate housing 22 and the longitudinal axis 406 of the blood vessel 128 until the ball bearing 248, which is disposed within the conical cavity 236 of the angle alignment mechanism 232, is centered on the axis of symmetry 238 of the conical cavity 236. Also at this stage, it may be useful to orient the axis 408 of the handle 46 of the actuator assembly 12 relative to the longitudinal axis 406 of the patient's blood vessel 128.

[0128] The plurality of anchor deployers 52 may here be deployed distally and radially outwardly away from the distal section 34 of the elongate housing 22 of the vascular occlusion assembly 10 by activating the actuator lever 264 of the anchor deployer actuator 256. For some embodiments, the step of activating the actuator lever 264 may include the step of depressing the actuator lever 264, which is operably coupled to the proximal section 262 of each of the plurality of deployer rods 56, as shown in FIGS. 53 and 54, to a carrier 258 of the anchor deployer. For some embodiments, depressing the actuator lever 264 results in rotation of the actuator lever 264, which in turn axially translates the carrier 258 of the anchor deployer and the proximal section 262 of the plurality of deployer rods 56 in the distal direction. The anchor deployers 52 may be deployed, as shown in FIG. 54, such that the anchors 62 extend distally beyond the distal end 28 of the elongate housing 22 and the tissue layer 64 is engaged, either pierced or otherwise, to assist in axial tension on the filament 66 at a location where the tissue layer 64 is positioned about the passage 216 within the tissue layer 64 using the individual anchors 62 of the plurality of anchor deployers 52. In some cases, deploying the plurality of anchor deployers 52 distally and radially outwardly away from the distal section 34 of the elongate housing 22 may include the step of deploying the plurality of anchor deployers 52 in an asymmetric pattern about the longitudinal axis 244 of the elongate housing 22, as shown in FIG. 20 and discussed above.

[0129] The anchor 62 is disposed about the passage 216 within the tissue layer 64 and, at these locations, is secured to the tissue layer 64. In some cases, the step of securing the anchor 62 to the tissue layer 64 at locations disposed about the passage 216 within the tissue layer 64 may include the step of penetrating the tissue layer 64 using each of the anchors 62 of the individual anchor deployer 52 and the step of removing each anchor 62 from its respective deployment rod 56 at a location directly beneath the tissue layer 64. Although the anchor embodiment 62 is shown as being deployed, the anchor embodiment 62' or 62'' or any other suitable anchor embodiment and associated anchor deployer embodiment 52 may be used for the method. At this stage, the actuator assembly 12 may also optionally be rotated and angularly oriented until the longitudinal axis 244 of the elongate housing 22 is substantially perpendicular to the longitudinal axis 406 of the blood vessel 128 prior to retracting the deployment rod 56 of the anchor deployer 52 proximally after deploying the anchor deployer 52. Such a perpendicular or substantially perpendicular orientation may be useful in some situations to facilitate the desired engagement of the anchor deployer 52 with the tissue layer 64.

[0130] The deployment rod 56 of the anchor deployer 52 may then be retracted proximally into the elongate housing 22 by releasing the spring-loaded anchor deployer actuator 256 as shown in FIG. 55 or by any other suitable means. The anchors 62 may here be pulled together by applying proximal tension to the filaments 66 secured to each of the anchors 62. The anchors 62 and the individual portions of the tissue layer 64 secured to each of the anchors 62 are thus pulled together to move closer to each other as the filaments 66 are generally radially spanned and translated inwardly, thereby reducing the transverse dimension of the passage 216 within the tissue layer 64.

[0131] In some instances, applying the proximal tension to the filaments 66 secured to each of the anchors 62 may include actuating a filament tensioning mechanism 336 configured to controllably apply the tension to the filaments 66. For some embodiments, the step of actuating the filament tensioning mechanism 336 may include controllably translating a filament end 338 secured to the filaments 66 and the tensioning spring 342. Additionally, for some embodiments, the step of controllably translating the filament end 338 may include rotating a knob 356 secured to a threaded rod 344 operatively coupled to a threaded bore 352 of a tension control block 348, and a tension transmission clip 354 releasably couples the filament end 338 to the tension control block 348 in an orientation opposing the tension of the tensioning spring 342. Additionally, for such embodiments, the step of rotating the knob 356 may reduce the counterforce of the tension applied by the tension control block 348 to controllably apply the tension of the tensioning spring 342 to the filaments 66. For such embodiments, the knob 356 may be rotated such that the tension control block 348 disengages the filament end 338 and all of the tension from the tensioning spring 342 is applied to the filaments 66 through the filament end 338, as shown in FIG. 57.

[0132] The balloon inflation valve 112 of the inner catheter assembly 78 then, at this stage, deactivates the balloon inflation lever 148 and thus may be closed by closing the balloon inflation lumen 102, which prevents fluid communication between the internal volume 150 of the blood vessel 128 and the internal volume 98 of the self-expanding balloon 94. Thus, the inflation pressure from within the internal volume 150 of the blood vessel 128 is excluded from the internal volume 98 of the self-expanding balloon 94, as shown in FIG. 37, and the internal volume 98 is also vented to the ambient atmosphere so as to return towards the proximal chassis 92 through the inflation port 104, thereby allowing the self-expanding balloon 94 to contract. The inner catheter assembly position locking portion 212 is then released, and the extension shaft 82 of the inner catheter assembly 78 and the self-expanding balloon 94 may be advanced slightly distally to relieve the mechanical interaction between the inner surface 152 of the blood vessel 128 and the deployed foot-like extension 166. The foot-like extension 166 may then be retracted back to the retracted position by deactivating the foot-like extension actuator 168 on the proximal chassis 92.

[0133] The inner catheter assembly 78 is then withdrawn proximally within and relative to the inner lumen 32 of the extension housing 22 of the actuator assembly 12 until the proximal index 226 of the actuator assembly 12 is aligned with the retraction alignment mark 228 on the extension shaft 82 of the inner catheter assembly 78. Such axial alignment of the inner catheter assembly 78 and the actuator assembly 12 indicates that the distal end 86 of the contracted self-expanding balloon 94 and the extension shaft 82 have been retracted proximally into the inner lumen 32 of the extension housing 22 and no longer interact with the access hole 124 or the passage 216 within the tissue layer 64. This alignment may also indicate that the extension shaft 82 of the inner catheter assembly 78 has been completely withdrawn with only the guide wire 117 remaining within the passage 216, as shown in FIG. 58.

[0134] As the inner catheter assembly 78 is withdrawn, the contracted self-expanding balloon 94 is simultaneously withdrawn from the access hole 124 and the passage 216 in the tissue layer 64, enabling tensioning to the filament 66 that is fixed to the tissue layer 64, and may completely close the passage 216 in the tissue layer 64. During this process, once the tension of the tensioning spring 342 is applied to the tethered filament 66, the tissue layer 64 disposed around the self-expanding balloon 94 is tightened around the outer surface 154 of the self-expanding balloon 94 to provide hemostasis during that time, regardless of whether the self-expanding balloon 94 is in the inflated or deflated state. However, the pressure of the tissue layer 64 disposed around the self-expanding balloon 94 and around the passage 216 is not large enough to prevent the outer surface 154 of the self-expanding balloon 94 and the distal extension shaft 82 of the self-expanding balloon 94 from sliding axially through the passage 216 of the tissue layer 64 during proximal withdrawal of the inner catheter assembly 78.

[0135] One or more filament locking portions 76 may then be deployed onto the filament 66 at the distal end 28 of the extension housing 22 by activating the filament locking mechanism 72 while maintaining the tension on the filament 66 using the tensioning spring 342. In certain cases, the step of activating the filament locking mechanism 72 may include depressing a filament tube actuator 374 coupled to a filament tube 37 disposed around the filament 66 within the extension housing 22, thereby retracting the filament tube 37 proximally as shown by arrow 375 in FIG. 59. The proximal retraction may continue until at least one filament locking portion 76 in the expanded state is pushed onto the filament 66 from the distal end 364 of the filament tube 37, as shown in FIG. 60.

[0136] With respect to such embodiments, the filament locking portion 76 may include a self - contracting configuration, and the deployment method embodiments may further include enabling the self - contracting filament locking portion 76 to contract to a relaxed state across the filament 66, such that once the outward radial support of the filament tube 37 is removed from within the filament locking portion 76, at least one filament locking portion 76 may be crimped onto the outer surface of the filament 66 and against each other. The outward radial support of the filament tube 37 against the inner surface of the filament locking portion 76 may be removed by retracting the distal end 364 of the filament tube 37 proximally past the distal shoulder 366 of the press - fit bore 362 and an optional filament locking portion bushing 373 disposed about the distal end 364 of the filament tube 37. In some cases, a plurality of filament locking portions 76 may be deployed onto the filament 66 by pushing the plurality of filament locking portions 76 from the distal end 364 of the filament tube 37 onto the filament 66. For example, in some cases, two, three, four, five, or more filament locking portions 76 may be deployed onto the filament 66 to fix the filaments 66 in a fixed relationship with each other and lock them in a tensioned state.

[0137] With respect to the illustrated filament locking portion embodiment 76, the step of crimping at least one filament locking portion 76 onto the filament 66 may include deflecting a plurality of proximally extending finger portions 382 of the trailing - edge locking filament locking portion embodiment 76 in an inward radial direction and crimping the proximal ends 386 of the proximally extending finger portions 382 onto the filament 66. In some cases, the deployment may include wedging a proximally extending finger portion 382 of the most distal trailing - edge locking filament locking portion embodiment 76 into the inner lumen 370 of a proximally adjacent filament locking portion 76 during deployment.

[0138] The filament 66 may then optionally be cut at a position proximal to the filament locking portion 76 by actuating the filament cutter 390 of the actuator assembly 12. As discussed above, the filament cutter 390 and its sharp blade 392 may be arranged in an operable array with the filament 66. In some cases, the sharp blade 392 of the tissue cutter 390 may be disposed within the sliding portion 394, and the step of actuating the filament cutter 390 of the actuator assembly 12 may include translating the sliding portion 394 and the sharp blade 392 parallel to the filament 66 within the bore 396, thereby approaching the filament 66 during the lateral translation and bringing the sharp edge 398 of the blade 392 into contact with the filament 66, thereby cutting through the filament 66. Once the filament 66 has been cut, the vascular closure assembly 10 may be removed from the patient and the treatment of the puncture site may be completed, as shown in FIG. 61.

[0139] The embodiments illustratively described herein in a preferred manner can be practiced in the absence of any element not specifically disclosed herein. Thus, for example, in each instance herein, any one of the terms "comprising", "consisting essentially of", and "consisting of" can be replaced with any one of the other two terms. The terms and expressions employed are used as terms of description and not of limitation, and the use of such terms and expressions does not exclude any equivalents or portions thereof of the features shown and described, and various modifications are possible. The term "a" or "an" can refer to one or more of the elements it modifies as long as it is not clear from the context that only one or more than one of the elements is being described (e.g., "a reagent" can mean one or more than one reagent). Thus, although embodiments have been specifically disclosed by way of representative embodiments and optional features, it should be understood that modifications and variations of the concepts disclosed herein can be used by those skilled in the art, and such modifications and variations are considered to be within the scope of this disclosure.

[0140] With respect to the foregoing detailed description, like reference numerals used therein refer to like elements that can have the same or similar dimensions, materials, and configurations. Although specific forms of embodiments have been illustrated and described, it will be apparent that steps can be made without departing from the spirit and scope of the embodiments of the present invention. Thus, the present invention is not intended to be limited by the foregoing details.

Claims

**Claim 1** A vascular occlusion assembly, an actuator assembly, wherein the actuator assembly comprises an elongate housing having an inner lumen extending along the elongate housing to a distal end of the elongate housing, a distal section, and a plurality of anchor deployer lumens, a plurality of anchor deployers, each anchor deployer being slidably disposed within an individual deployer lumen of the elongate housing and including a distal end configured to extend and expand from the distal section of the elongate housing, an actuator assembly including an inner catheter assembly, wherein the inner catheter assembly comprises an elongate shaft having a proximal end, a distal end, a distal section, and an axial length sufficient for the distal section to extend distally beyond the distal end of the elongate housing when disposed within its inner lumen, and an outer profile configured to be slidably disposed within the inner lumen of the elongate housing, an inflatable balloon disposed on the distal section of the elongate shaft at an axial position where the inflatable balloon can extend distally from the distal end of the elongate housing when the elongate shaft is disposed within the inner lumen of the elongate housing, the inflatable balloon including an internal volume in communication with a balloon inflation lumen, the balloon inflation lumen extending along the elongate shaft from an inflation port disposed to be in fluid communication with the internal volume of the inflatable balloon to an inlet port disposed on the elongate shaft, a balloon inflation valve configured to controllably open and close the balloon inflation lumen, an inner catheter assembly including a vascular occlusion assembly comprising. **Claim 2** The vascular occlusion assembly according to claim 1, wherein the inflatable balloon comprises a self-expanding balloon. **Claim 3** The vascular occlusion assembly according to claim 1, further comprising a guide wire lumen extending along the elongate shaft to a distal guide wire port disposed at the distal end of the elongate shaft. **Claim 4** The self-expanding balloon is sized to fit within the inner lumen of the extension housing and is configured to self-expand from a compressed state having a lateral dimension smaller than the outer lateral dimension of the extension shaft to an expanded state having an outer lateral dimension greater than the outer lateral dimension of the extension shaft and configured to occlude an access hole within the wall of a patient's blood vessel, and the vascular occlusion assembly according to claim 2, comprising an outer outer shape.

5. The self-expanding balloon, in an expanded state, has an elongated outer profile in which the nominal axial length of the self-expanding balloon exceeds the lateral dimension of the self-expanding balloon, and the vascular occlusion assembly according to claim 4.

6. The balloon inflation valve is a plug, the plug having an outer profile that matches the inner profile of the balloon inflation lumen so as to prevent fluid flow through the balloon inflation lumen and be slidably disposed within the balloon inflation lumen, the plug an actuator rod having a distal end fixed to the plug, a balloon inflation lever, the balloon inflation lever being operably coupled to the proximal end of the actuator rod and disposed on the proximal chassis of the inner catheter assembly, the plug being disposed distal to the inflation port of the balloon inflation lumen, whereby the plug is slidable from a first position that blocks fluid communication between the inlet port and the inflation port of the balloon inflation lumen to a second position, the second position being proximal to the first position and proximal to the inflation port so as to allow fluid communication between the inlet port and the inflation port through the balloon inflation lumen, the balloon inflation lever and the vascular occlusion assembly according to claim 2.

7. The balloon inflation valve comprises a tubular member configured to be axially displaced within the balloon inflation lumen of the extension shaft, having a pair of ports, the pair of ports being coupled to communicate with each other, and when the tubular member is disposed in an open axial position, being axially positioned to align with the inlet port and the inflation port of the extension shaft, and when in a closed axial position, being positioned so as not to align with the inlet port and the inflation port, and the vascular occlusion assembly according to claim 2.

8. The vascular occlusion assembly according to claim 2, further comprising a foot-like extension disposed on the extension shaft within the internal volume of the self-expanding balloon, the foot-like extension being from a retracted position where the foot-like extension is substantially disposed within the nominal outer contour of the extension shaft, to a deployed position where the outer end of the foot-like extension extends radially outwardly from the nominal outer contour of the extension shaft, configured to extend outwardly.

9. The extension shaft further comprises an insertion alignment mark visually distinguishable by a user, the actuator assembly further comprises a proximal index visually distinguishable by a user, and in the deployed state, the foot-like extension is spaced a predetermined axial separation from the distal end of the extension housing when the insertion alignment mark is axially aligned with the proximal index. The vascular occlusion assembly according to claim 8.

10. The vascular occlusion assembly according to claim 9, wherein the proximal index and the insertion alignment mark are positioned such that the predetermined axial separation is between about 260 mm and about 285 mm.

11. The extension shaft further comprises a retraction alignment mark visually distinguishable by a user, and the distal end of the self-expanding balloon is disposed within the inner lumen of the extension housing when the retraction alignment mark is axially aligned with the proximal index. The vascular occlusion assembly according to claim 9.

12. A vascular occlusion assembly, An actuator assembly, the actuator assembly comprising An outer shell, a chassis portion having an internal volume disposed within the outer shell, An extension housing, the extension housing having a proximal end fixed to the distal end of the chassis portion, a distal end extending away from the chassis portion, an inner lumen extending along the extension housing to the distal end of the extension housing, a distal section, and a plurality of anchor deployer lumens, each anchor deployer lumen extending axially along the extension housing and terminating distally at a distal port disposed within the distal section of the extension housing. An extension housing, A plurality of anchor deployers, each anchor deployer being slidably disposed within an individual deployer lumen of the extension housing and including a distal end configured to extend and spread from the distal section of the extension housing. Each anchor deployer A deployment rod, the deployment rod including an elongate elastic configuration having an axial length greater than a lateral dimension and a distal end extending from a distal section of the elongate housing in response to distal axial deployment, the deployment rod An anchor removably secured to the distal end of the deployment rod and configured to resist proximal retraction within tissue Comprising a plurality of anchor deployers Including an actuator assembly An inner catheter assembly, the inner catheter assembly An elongate shaft, the elongate shaft including a proximal end, a distal end, a distal section, the distal section having an axial length sufficient to extend distally beyond the distal end of the elongate housing when disposed within its inner lumen, and an outer profile configured to be slidably disposed within the inner lumen of the elongate housing, the elongate shaft An inflatable balloon, the inflatable balloon disposed on the distal section of the elongate shaft at an axial position where the inflatable balloon can extend distally from the distal end of the elongate housing when the elongate shaft is disposed within the inner lumen of the elongate housing, the inflatable balloon including an internal volume in communication with a balloon inflation lumen, the inflatable balloon A balloon inflation valve configured to controllably open and close the balloon inflation lumen Including an inner catheter assembly Comprising a vascular occlusion assembly

13. A vascular occlusion assembly, the vascular occlusion assembly An actuator assembly, the actuator assembly Having an outer shell and a chassis portion having an internal volume disposed within the outer shell An elongate housing, the elongate housing including a proximal end secured to the distal end of the chassis portion, a distal end extending away from the chassis portion, an inner lumen extending along the elongate housing to the distal end of the elongate housing, a distal section, and a plurality of anchor deployer lumens, each anchor deployer lumen extending axially along the elongate housing and terminating distally at a distal port disposed within the distal section of the elongate housing, the elongate housing further comprising a filament lumen extending along the elongate housing and terminating at a distal port disposed within the distal section of the elongate housing, the elongate housing A plurality of anchor deployers, each anchor deployer slidably disposed within an individual deployer lumen of the elongate housing and including a distal end configured to extend and spread from the distal section of the elongate housing, each anchor deployer A deployment rod, the deployment rod including an elongate resilient configuration having an axial length that exceeds a lateral dimension and a distal end that extends from a distal segment of the elongate housing in response to distal axial deployment, the deployment rod An anchor removably secured to the distal end of the deployment rod and configured to resist proximal retraction within tissue A filament, the filament being slidably disposed within a filament lumen of the elongate housing and including a distal end secured to the anchor Comprising a plurality of anchor deployers Including an actuator assembly An inner catheter assembly, the inner catheter assembly An elongate shaft, the elongate shaft including a proximal end, a distal end, a distal segment, and an axial length sufficient for the distal segment to extend distally beyond the distal end of the elongate housing when disposed within its inner lumen, and an outer profile configured to be slidably disposed within the inner lumen of the elongate housing, the elongate shaft An inflatable balloon, the inflatable balloon being disposed on the distal segment of the elongate shaft at an axial position where it can extend distally from the distal end of the elongate housing when the elongate shaft is disposed within the inner lumen of the elongate housing, the inflatable balloon including an internal volume in communication with a balloon inflation lumen Including an inner catheter assembly Comprising a vascular occlusion assembly

14. The vascular occlusion assembly according to claim 12, further comprising a handle portion having an upper end secured to the chassis portion and a proximal chassis secured to the proximal end of the elongate shaft

15. The vascular occlusion assembly according to claim 12, wherein the inflatable balloon comprises a self-expanding balloon

16. A vascular occlusion assembly, An actuator assembly, the actuator assembly Having an outer shell and a chassis portion having an internal volume disposed within the outer shell An elongate housing, the elongate housing having a proximal end fixed to the distal end of the chassis portion, a distal end extending away from the chassis portion, an inner lumen extending along the elongate housing to the distal end of the elongate housing, a distal section, and a plurality of anchor deployer lumens, each anchor deployer lumen extending axially along the elongate housing and terminating distally at a distal port disposed within the distal section of the elongate housing, the elongate housing and A plurality of anchor deployers, each anchor deployer including a distal end slidably disposed within an individual deployer lumen of the elongate housing and configured to extend and spread from the distal section of the elongate housing, each anchor deployer and A deployment rod, the deployment rod including an elongate resilient configuration with an axial length greater than a transverse dimension and a distal end extending from the distal section of the elongate housing in response to distal axial deployment, the deployment rod and An anchor removably fixed to the distal end of the deployment rod and configured to resist proximal retraction within tissue Comprising a plurality of anchor deployers Including an actuator assembly An inner catheter assembly, the inner catheter assembly and An elongate shaft, the elongate shaft having a proximal end, a distal end, a distal section, and an axial length sufficient for the distal section to extend distally beyond the distal end of the elongate housing when disposed within its inner lumen, and an outer profile configured to be slidably disposed within the inner lumen of the elongate housing, the elongate shaft and An inflatable balloon, the inflatable balloon disposed on the distal section of the elongate shaft at an axial position where it can extend distally from the distal end of the elongate housing when the elongate shaft is disposed within the inner lumen of the elongate housing, the inflatable balloon including an internal volume in communication with a balloon inflation lumen, the inflatable balloon and Including an inner catheter assembly Comprising The actuator assembly further includes an inner catheter assembly position locking portion, and the inner catheter assembly position locking portion releasably secures the inner catheter assembly to the actuator assembly and applies a frictional force to the outer surface of the inner catheter assembly disposed within the inner lumen of the extension housing so as to temporarily prevent axial displacement of the inner catheter assembly relative to the actuator assembly. A vascular occlusion assembly configured as such.

17. An anchor deployer actuator, An anchor deployer carrier, wherein the anchor deployer carrier is slidably disposed relative to the chassis portion and operably coupled to a proximal section of each of the plurality of deployer rods. An anchor deployer carrier, An actuator lever, wherein the actuator lever extends outside the chassis portion and operably couples to the anchor deployer carrier to translate the anchor deployer carrier distally in response to an actuating translation, thereby causing each of the deployer rods to translate axially distally in response to the actuating translation. An actuator lever An anchor deployer actuator comprising The vascular occlusion assembly according to claim 12, further comprising

18. The vascular occlusion assembly according to claim 12, wherein each distal section of the anchor deployer lumen is configured to provide an outward angular deflection of the anchor deployer extending outwardly from a distal port of the anchor deployer lumen.

19. The vascular occlusion assembly according to claim 18, wherein each distal section of the anchor deployer lumen has a curved profile with respect to a longitudinal axis of a nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen, and provides an outward angular deflection of the anchor deployer extending outwardly from a distal port of the anchor deployer lumen.

20. The vascular occlusion assembly according to claim 18, wherein the anchor deployer lumen is configured to produce an asymmetric deployment pattern of the anchor deployer with respect to a longitudinal axis of the extension housing.

21. The vascular occlusion assembly according to claim 20, wherein each axial position and firing axis of the anchor deployer lumen is configured to produce the asymmetric deployment pattern with respect to a longitudinal axis of the extension housing.

22. The curved contour of the distal section of the first anchor deployer lumen comprises a firing axis that forms a first angle with the longitudinal axis of a nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen. The curved contour of the distal section of the second anchor deployer lumen comprises a firing axis that forms a second angle with the longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen, and the second angle is different from the first angle. The vascular occlusion assembly according to claim 21.

23. Each anchor of the plurality of anchor deployers includes a sharp distal tip configured to penetrate tissue in a distal direction. The vascular occlusion assembly according to claim 12.

24. Each deployment rod of the plurality of anchor deployers comprises a sharp tissue-penetrating tip disposed on the distal end of the deployment rod, and the anchor removably fixed to the distal end of the deployment rod has a tubular configuration without a sharp distal tip. The vascular occlusion assembly according to claim 12.

25. The vascular occlusion assembly according to claim 12, further comprising a filament tensioning mechanism configured to controllably apply axial tension to the filaments of the individual plurality of anchor deployers.

26. The vascular occlusion assembly according to claim 13, further comprising a filament locking mechanism disposed at the distal end of the filament lumen, the filament locking mechanism including a filament locking portion disposed in an operable arrangement with the filaments of the individual plurality of anchor deployers.

27. The filament locking mechanism is a filament tube having a distal section slidably disposed within a snug bore in the distal section of the elongate housing, the filament tube having a distal end extending distally beyond the distal shoulder surface of the snug bore, being slidably disposed relative to the elongate housing, having an inner lumen disposed about the filament, and having a proximal section; a filament tube A filament locking portion, wherein the filament locking portion has an inner lumen disposed about a distal end of the filament tube at an axial position distal to a distal shoulder surface of the snug bore, and once an outward radial support that produces an expanded state of the filament tube is removed, self - contracts from the expanded state to a relaxed state and is configured to crimp onto the filament disposed within the inner lumen of the filament tube, a filament locking portion; A filament tube actuator, wherein the filament tube actuator is operably coupled to a proximal segment of the filament tube and is configured to axially retract the filament tube relative to the distal shoulder surface such that activation causes the filament locking portion to be pushed distally from the distal end of the filament tube and enables the filament locking portion to crimp onto the filament disposed within the inner lumen of the filament tube, a filament tube actuator; The vascular occlusion assembly according to claim 26, comprising the above.

28. The filament locking mechanism of claim 27, wherein the filament locking mechanism comprises a plurality of filament locking portions disposed axially adjacent to each other on a distal end of the filament tube at an axial position distal to a distal shoulder surface of the snug bore.

29. The vascular occlusion assembly according to claim 27, wherein the filament tube comprises a rigid tubular structure made of a high - strength material.

30. The vascular occlusion assembly according to claim 27, wherein the filament locking portion comprises a coiled spring filament, the inner lumen is sized to crimp onto the filament disposed therein when in a contracted state, and the inner lumen can be elastically expanded to a lateral dimension sufficient to fit onto an outer surface of the distal end of the filament tube.

31. The filament locking portion has a tubular structure, the tubular structure includes a main body portion, and also includes a plurality of finger portions extending proximally from the main body portion. The finger portions are such that the individual distal ends of the finger portions self-shrink from an expanded state to a relaxed state, and are configured to crimp onto the filament disposed within the inner lumen of the filament locking portion when the finger portions are in the relaxed state. The finger portions have a sufficient axial length and are elastically biased toward the central longitudinal axis of the main body portion. The finger portions can elastically spread to a relative lateral separation to the expanded state sufficient to fit onto the outer surface of the distal end of the filament tube. The vascular occlusion assembly according to claim 27.

32. The vascular occlusion assembly according to claim 31, wherein the filament locking portion includes about 3 to about 10 finger portions.

33. The vascular occlusion assembly according to claim 12, wherein the actuator assembly further includes a filament cutter disposed in an operable arrangement with the filaments of the individual plurality of anchor deployers.

34. A catheter assembly, an elongate shaft including a proximal end, a distal end, and a distal section, a proximal chassis secured to the proximal end of the elongate shaft, a self-expanding balloon disposed on the distal section of the shaft, the self-expanding balloon including a shell material that is thin enough and compliant enough to conform to the outer contour of the foot-like extensions, and an internal volume in communication with a balloon inflation lumen. The balloon inflation lumen extends along the elongate shaft from an inflation port disposed to be in fluid communication with the internal volume of the self-expanding balloon to an inlet port disposed on the elongate shaft at an axial position distal to the distal end of the self-expanding balloon. A self-expanding balloon, a balloon inflation valve configured to controllably open and close the balloon inflation lumen The catheter assembly comprising.

35. The catheter assembly according to claim 34, further comprising a foot-like extension disposed on the extension shaft within the internal volume of the self-expanding balloon, the foot-like extension extending outwardly from a retracted position in which the foot-like portion is substantially disposed within the nominal outer contour of the shaft to a deployed position in which an outer end of the foot-like extension extends radially outwardly from the nominal outer contour of the shaft that is substantially perpendicular to the longitudinal axis of the extension shaft. **Claim 36** The catheter assembly according to claim 35, further comprising a foot-like extension actuator configured to vary the state of the foot-like extension between the retracted position and the deployed position. **Claim 37** The catheter assembly according to claim 34, further comprising a blood return lumen that extends proximally from a distal end of the extension shaft to a proximal port of the blood return lumen disposed proximal to the self-expanding balloon. **Claim 38** The catheter assembly according to claim 34, further comprising a guide wire lumen that extends along the extension shaft to a distal guide wire port disposed at a distal end of the extension shaft.

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