Vascular closure devices and methods

Abstract

To provide favorable vascular closure devices and favorable vascular closure methods.SOLUTION: The invention provides, e.g., favorable vascular closure devices and favorable vascular closure methods. Embodiments regarding a vascular closure assembly disclosed herein may be used to provide hemostasis at vascular puncture sites or at their equivalents. Such vascular puncture or access sites may be created during a variety of percutaneous or minimally invasive medical procedures.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 937,675, filed November 19, 2019 by B. Hauck et al., and entitled "Vascular Closure Devices," which is incorporated by reference in its entirety herein. [Background technology]

[0002] In many percutaneous procedures, a catheter is inserted into an access hole in a blood vessel, such as the femoral artery. Such percutaneous procedures may include minimally invasive cardiovascular procedures, including, for example, balloon angioplasty procedures, atherectomy procedures, cardiovascular stent deployment, heart valve replacement, and others. During such procedures, a therapeutic catheter may typically be inserted directly into the artery over a guidewire, or the catheter may be inserted through a vascular introducer sheath. Once the therapeutic procedure is complete, the physician generally removes the therapeutic catheter and then removes the introducer sheath (if used) from the vessel. The physician must then prevent or limit the amount of blood leaking through the vascular access hole. Physicians currently 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. Still further, some of such procedures, particularly suture-mediated closure devices, are known to have high failure rates in the presence of common vascular diseases such as atherosclerosis and calcification. Summary of the Invention [Means for solving the problem]

[0004] Some embodiments of the vascular closure assembly may include an actuator assembly having an elongated housing with an inner lumen extending along the elongated housing to a distal end of the elongated housing. The elongated housing may also have a distal section and multiple anchor deployer lumens. The actuator assembly may also include multiple anchor deployers, each slidably disposed within a respective anchor deployer lumen of the elongated housing, each anchor deployer including a distal end that is configured to extend and diverge distally and radially outwardly from the distal section of the elongated housing. The vascular closure assembly may also have an inner catheter assembly including an elongated shaft having a proximal end, a distal end, a distal section, an axial length sufficient to extend distally beyond the distal end of the elongated housing when the distal section is disposed within its inner lumen, and an outer surface contour configured to be slidably disposed within the inner lumen of the elongated housing. The inner catheter assembly may further include an inflatable balloon disposed on the distal section of the elongate shaft at an axial location that may 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 may have an interior volume in communication with a balloon inflation lumen extending along the elongate shaft from an inflation port disposed in fluid communication with the interior volume of the self-inflating 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 forming an interior volume disposed within the outer shell. The actuator assembly may further include an elongated housing with 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 elongated housing to the distal end of the elongated housing, a distal section, and multiple anchor deployer lumens. In some cases, each anchor deployer lumen may extend axially along the elongated housing and terminate distally at a distal port disposed within the distal section of the elongated housing. The actuator assembly may also include multiple anchor deployers, each anchor deployer including a distal end slidably disposed within a respective anchor deployer lumen of the elongated housing and configured to extend and diverge 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 elongated elastic configuration with an axial length that exceeds its lateral dimension and a distal end that extends from the distal section of the elongated housing upon distal axial deployment. Each anchor deployer may also have an anchor that is removably secured 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 an elongated shaft with 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 elongated housing when disposed within its inner lumen, and an outer surface contour configured to be slidably disposed within the inner lumen of the elongated housing. The inner catheter assembly may further include an inflatable balloon disposed on the distal section of the elongated shaft at an axial location that may extend distally from the distal end of the elongated housing when the elongated shaft is disposed within the inner lumen of the elongated housing. The inflatable balloon may have an interior volume in fluid communication with the balloon inflation lumen.

[0006] Some embodiments of the actuator assembly may include a chassis portion having an outer shell with an interior volume disposed within the outer shell. The actuator assembly may further include an elongated housing with an axial length that exceeds its lateral dimension, a proximal end secured to a distal end of the chassis portion, a distal end extending away from the chassis portion, and an inner lumen extending along the elongated housing to the distal end of the elongated housing. The elongated housing may also include a distal section, a filament lumen extending along the elongated housing and terminating at a distal port disposed within the distal section of the elongated housing, and a plurality of anchor deployer lumens. In some cases, each anchor deployer lumen may extend axially along the elongated housing and terminate distally at a distal port disposed within the distal section of the elongated housing. The actuator assembly may also include a plurality of anchor deployers, each of which includes a distal end slidably disposed within a respective anchor deployer lumen of the elongate housing and configured to extend and diverge distally and radially outwardly from the distal section of the elongate housing. For some embodiments, each anchor deployer may include a deployment rod having an elongated elastic configuration with an axial length that exceeds the lateral dimension and a distal end that extends from the distal section of the elongate housing upon distal axial deployment. The anchor deployers may also each include an anchor that is removably secured to the distal end of the deployment rod. Each anchor deployer may also include a filament that is slidably disposed within the filament lumen of the elongate housing and has a distal end secured to the anchor. The actuator assembly may also include a filament locking mechanism including a filament lock disposed at the distal end of the filament lumen and in operable alignment with the filament of the respective 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 section, and a proximal chassis secured to the proximal end of the elongate shaft. The catheter assembly may also include a self-inflating balloon disposed on the distal section of the shaft, the self-inflating balloon having a thin compliant shell material and an interior volume in communication with a balloon inflation lumen extending along the elongate shaft from an inflation port disposed in fluid communication with the interior volume of the self-inflating balloon to an inlet port disposed on the elongate shaft at an axial location distal to the distal end of the self-inflating 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 fingers extending proximally from the main body portion. In some cases, the fingers may be of sufficient axial length and resiliently biased toward a central longitudinal axis of the main body portion such that, when the fingers are in a relaxed state, individual distal ends of the fingers are configured to self-contract from an expanded state to a relaxed state and to crimp onto a filament disposed within the inner lumen of the filament locking portion. Additionally, the fingers may be configured to resiliently spread apart in relative lateral separation to an expanded state sufficient to fit onto an outer surface of a distal end of a filament tube.

[0009] Some embodiments of a method for vascular closure may include advancing a vascular closure assembly distally toward an access hole in a blood vessel and a passageway disposed in a tissue layer adjacent to the blood vessel. In some cases, the vascular closure assembly may be so advanced while an inner catheter assembly of the vascular closure assembly is disposed within an inner lumen of an elongated housing of an actuator assembly of the vascular closure assembly. In addition, the vascular closure assembly may be so advanced distally with an inflatable balloon of the inner catheter assembly extending distally beyond a distal end of the elongated housing. The method may also include inflating the inflatable balloon until contact and hemostasis are established between an outer surface of the self-inflating balloon and a surrounding surface of the access hole in 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 a fixed axial position relative to the access hole in the blood vessel until a distal end of the elongated housing of the actuator assembly is disposed adjacent to the passageway in the tissue layer. The multiple anchor deployers may then be deployed using an anchor deployer actuator to extend distally and radially outwardly away from a distal section of the elongate housing of the vascular closure assembly. The anchor deployers may further engage the tissue layer with individual anchors of the multiple anchor deployers at fixed positions centered about the passage in the tissue layer. The method may also include pulling the anchors closer together by applying proximal tension to filaments secured to each of the anchors to pull together the anchors and individual portions of the tissue layer secured to each of the anchors, thereby reducing a lateral dimension of the passage in the tissue layer. For some embodiments, a filament lock may be deployed on the filament at the distal end of the elongate housing by activating a filament locking mechanism while maintaining tension on the filament with a tension spring.

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

[0011] Some embodiments of a method for vascular closure may include advancing the actuator assembly distally until a distal end of an elongated housing of the actuator assembly is disposed adjacent to the passage in the tissue layer. The method may further include deploying a plurality of anchor deployers distally and radially outwardly from the elongated housing in an asymmetric pattern about a longitudinal axis of the elongated housing, and engaging the tissue layer with individual anchors of the plurality of anchor deployers at fixed positions disposed in the asymmetric deployment pattern about the passage in the tissue layer. The anchors may then be pulled closer together by applying tension to filaments secured to each of the individual anchors to pull together the anchors and individual portions of the tissue layer secured to each of the anchors, thereby reducing a lateral dimension of the passage in the tissue layer, and then deploying a filament lock on the filament at the distal end of the elongated housing while maintaining tension on the filament.

[0012] Certain embodiments are further described in the following description, examples, claims, and drawings. These features of the embodiments will become more apparent from the following detailed description when considered in conjunction with the accompanying exemplary drawings. The present invention provides, for example, the following: (Item 1) 1. A vascular closure assembly comprising: An actuator assembly, comprising: an elongated housing with an inner lumen extending along the elongated housing to a distal end of the elongated housing, a distal section, and a plurality of anchor deployer lumens; a plurality of anchor deployers, each anchor deployer being slidably disposed within a respective deployer lumen of the elongate housing and including a distal end configured to extend and diverge from a distal section of the elongate housing; an actuator assembly including: 1. An inner catheter assembly, comprising: an elongated shaft including 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 elongated housing when disposed within its inner lumen, and an outer surface contour configured to be slidably disposed within the inner lumen of the elongated housing; an inflatable balloon disposed on a distal section of the elongate shaft at an axial location that may 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 interior volume in communication with a balloon inflation lumen, the balloon inflation lumen extending along the elongate shaft from an inflation port disposed in fluid communication with the interior volume of the inflatable balloon to an inlet port disposed on the elongate shaft; an inner catheter assembly including: A vascular closure assembly comprising: (Item 2) Item 14. The vascular closure assembly of item 1, wherein the inflatable balloon comprises a self-inflating balloon and further comprises a balloon inflation valve configured to controllably open and close the balloon inflation lumen. (Item 3) 2. The vascular closure assembly of claim 1, further comprising a guidewire lumen extending along the elongate shaft to a distal guidewire port disposed at a distal end of the elongate shaft. (Item 4) 2. The vascular closure assembly of item 1, wherein the self-inflating balloon has an outer profile configured to self-expand from a compressed state sized to fit within an inner lumen of the elongated housing to an expanded state having an outer lateral dimension greater than an outer lateral dimension of the elongated shaft and configured to plug an access hole in a wall of a patient's blood vessel. (Item 5) Item 5. The vascular closure assembly of item 4, wherein the self-inflating balloon has an elongated outer contour such that, in an inflated state, a nominal axial length of the self-inflating balloon exceeds a lateral dimension of the self-inflating balloon. (Item 6) The balloon inflation valve includes: an obturator, the obturator preventing fluid flow through the balloon inflation lumen and having an outer surface contour that matches an inner surface contour of the balloon inflation lumen so as to be slidably disposed within the balloon inflation lumen; an actuator rod having a distal end secured to the obturator; a balloon inflation lever operably coupled to a proximal end of the actuator rod, the balloon inflation lever being disposed on a proximal chassis of the inner catheter assembly, the balloon inflation lever being slidable from a first position in which the obturator is disposed distal to an inflation port of the balloon inflation lumen thereby blocking fluid communication between the inlet portion and the inflation port of the balloon inflation lumen, to a second position 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; 3. The vascular closure assembly of item 2 comprising: (Item 7) 3. The vascular closure assembly of item 2, wherein the balloon inflation valve comprises a tubular member configured to be axially displaced within a balloon inflation lumen of the elongate shaft, the tubular member having a pair of ports coupled in fluid communication with each other and axially positioned to align with an inlet port and an inflation port of the elongate shaft when the tubular member is disposed in the open axial position and positioned out of alignment with the inlet port and inflation port when the tubular member is in the closed axial position. (Item 8) 2. The vascular closure assembly of item 1, further comprising a foot extension disposed on the elongate shaft within the interior volume of the self-inflating balloon, the foot extension configured to extend outward from a retracted position in which the foot extension is disposed substantially within a nominal outer contour of the elongate shaft to a deployed position in which an outer end of the foot extension extends radially outward from the nominal outer contour of the elongate shaft. (Item 9) 9. The vascular closure assembly of item 8, wherein the elongated shaft further comprises an insertion alignment mark visually identifiable by a user, the actuator assembly further comprises a proximal index visually identifiable by a user, and the foot-like extension, in a deployed state, is spaced a predetermined axial separation from the distal end of the elongated housing when the insertion alignment mark is axially aligned with the proximal index. (Item 10) 10. The vascular closure assembly of claim 9, wherein the proximal index and insertion alignment marks are positioned such that the predetermined axial separation is between about 260 mm and about 285 mm. (Item 11) 10. The vascular closure assembly of item 9, wherein the elongated shaft further comprises a retraction alignment mark visually identifiable by a user, and wherein a distal end of the self-inflating balloon is positioned within the inner lumen of the elongated housing when the retraction alignment mark is axially aligned with the proximal index. (Item 12) 1. A vascular closure assembly comprising: An actuator assembly, comprising: a chassis portion having an outer shell with an interior volume disposed within the outer shell; an elongated housing with a proximal end secured to a distal end of the chassis portion, a distal end extending away from the chassis portion, an inner lumen extending along the elongated housing to the distal end of the elongated housing, a distal section, and a plurality of anchor deployer lumens, each anchor deployer lumen extending axially along the elongated housing and terminating distally at a distal port disposed within the distal section of the elongated housing; A plurality of anchor deployers, each anchor deployer being slidably disposed within a respective deployer lumen of the elongate housing and including a distal end configured to extend and diverge from a distal section of the outer housing, each anchor deployer comprising: a deployment rod including an elongated elastic configuration with an axial length that exceeds a lateral dimension and a distal end that extends from a distal section of the elongated housing in response to distal axial deployment; an anchor removably secured to a distal end of the deployment rod and configured to resist proximal retraction within tissue; A plurality of anchor deployers, an actuator assembly including: 1. An inner catheter assembly, comprising: an elongated shaft including 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 elongated housing when disposed within its inner lumen, and an outer surface contour configured to be slidably disposed within the inner lumen of the elongated housing; an inflatable balloon disposed on a distal section of the elongate shaft at an axial location that 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 interior volume in communication with a balloon inflation lumen; an inner catheter assembly including: A vascular closure assembly comprising: (Item 13) Item 13. The vascular closure assembly of item 12, wherein the elongate housing further comprises a filament lumen extending along the elongate housing and terminating in a distal port disposed within a distal section of the elongate housing, and each anchor deployer further comprises a filament, the filament slidably disposed within the filament lumen of the elongate housing and including a distal end secured to the anchor. (Item 14) Item 13. The vascular closure assembly of item 12, further comprising a handle portion having an upper end secured to the chassis portion and a proximal chassis secured to a proximal end of the elongate shaft. (Item 15) Item 13. The vascular closure assembly of item 12, wherein the inflatable balloon comprises a self-inflating balloon and further comprises a balloon inflation valve configured to controllably open and close the balloon inflation lumen. (Item 16) Item 13. The vascular closure assembly of item 12, wherein the actuator assembly further comprises an inner catheter assembly position lock configured to apply a frictional force to an outer surface of the inner assembly disposed within the inner lumen of the elongate body so as to releasably secure the inner catheter assembly to the actuator assembly and temporarily prevent axial displacement of the inner catheter assembly relative to the actuator assembly. (Item 17) 1. An anchor deployer actuator, comprising: an anchor deployer carrier slidably disposed relative to the chassis portion and operably coupled to a proximal section of each of the plurality of deployer rods; an actuator lever extending outside the chassis portion and operatively coupled to the anchor deployer carrier for distally translating the anchor deployer carrier in response to an actuation translation, thereby axially distally translating each of the deployer rods in response to an actuation translation; An anchor deployer actuator comprising: Item 13. The vascular closure assembly of item 12, further comprising: (Item 18) Item 13. The vascular closure assembly of item 12, wherein a distal section of each of the anchor deployer lumens is configured to provide an outward angular deflection of the anchor deployer extending outwardly from a distal port of the anchor deployer lumen. (Item 19) Item 19. The vascular closure assembly of item 18, wherein a distal section of each of the anchor deployer lumens comprises a curved profile relative to a longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen to provide an outward angular deflection of the anchor deployer extending outward from a distal port of the anchor deployer lumen. (Item 20) Item 19. The vascular closure assembly of item 18, wherein the anchor deployer lumen is configured to produce an asymmetric deployment pattern of the anchor deployer relative to a longitudinal axis of the elongate housing. (Item 21) 21. The vascular closure assembly of claim 20, wherein the axial positions and firing axes of each of the anchor deployer lumens are configured to produce the asymmetric deployment pattern relative to the longitudinal axis of the elongate housing. (Item 22) 22. The vascular closure assembly of item 21, wherein the curved profile of the distal section of a first anchor deployer lumen comprises a firing axis that forms a first angle with respect to a longitudinal axis of the nominal anchor deployer lumen section that is disposed proximal to the distal section of the anchor deployer lumen, and the curved profile of the distal section of a second anchor deployer lumen comprises a firing axis that forms a second angle with respect to a longitudinal axis of the nominal anchor deployer lumen section that is disposed proximal to the distal section of the anchor deployer lumen, the second angle being different from the first angle. (Item 23) Item 13. The vascular closure assembly of item 12, wherein each anchor of the plurality of anchor deployers includes a sharp distal tip configured to penetrate distally into tissue. (Item 24) Item 13. The vascular closure assembly of item 12, wherein each deployment rod of the plurality of anchor deployers includes a sharp tissue-piercing tip disposed on a distal end of the deployment rod, and the anchor removably secured to the distal end of the deployment rod has a tubular configuration without a sharp distal tip. (Item 25) Item 13. The vascular closure assembly of item 12, further comprising a filament tensioning mechanism configured to controllably apply axial tension to filaments of the individual plurality of anchor deployers. (Item 26) Item 13. The vascular closure assembly of item 12, further comprising a filament locking mechanism disposed at a distal end of the filament lumen, the filament locking mechanism including a filament locking portion disposed in operable alignment with a filament of the respective plurality of anchor deployers. (Item 27) The filament locking mechanism includes: a filament tube having a distal section slidably disposed within a close-fitting bore in a distal section of the elongated housing, the filament tube having a distal end extending distally beyond a distal shoulder surface of the close-fitting bore, the filament tube having an inner lumen slidably disposed relative to the elongated housing and disposed about the filament, and a proximal section; a filament lock having an inner lumen centered about the distal end of the filament tube at an axial location distal to a distal shoulder surface of the close-fitting bore, the filament lock being configured to self-contract from an expanded state to a relaxed state and to crimp onto the filament disposed within the inner lumen of the filament tube once an outward radial support producing an expanded state of the filament tube is removed; a filament tube actuator operably coupled to a proximal section of the filament tube and configured, upon activation, to push the filament lock from a distal end of the filament tube and axially retract the filament tube against the distal shoulder surface to allow the filament lock to crimp onto the filament disposed within an inner lumen of the filament tube; 27. The vascular closure assembly of claim 26, comprising: (Item 28) 28. The vascular closure assembly of claim 27, wherein the filament locking mechanism comprises a plurality of filament locking portions disposed axially adjacent to one another on the distal end of the filament tube at an axial location distal to a distal shoulder surface of the close-fitting bore. (Item 29) 28. The vascular closure assembly of claim 27, wherein the filament tube comprises a rigid tubular structure made of a high strength material. (Item 30) Item 28. The vascular closure assembly of item 27, wherein the filament lock 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 a distal end of the filament tube. (Item 31) 27. The vascular closure assembly of claim 26, wherein the filament locking portion comprises a tubular structure including a main body portion and including a plurality of fingers extending proximally from the main body portion, the fingers being of sufficient axial length and resiliently biased toward a central longitudinal axis of the main body portion such that when the fingers are in the relaxed state, individual distal ends of the fingers are configured to self-contract from an expanded state to a relaxed state and crimp onto the filament disposed within an inner lumen of the filament locking portion, the fingers being resiliently biased toward a central longitudinal axis of the main body portion, the fingers being resiliently spreadable in relative lateral separation to an expanded state sufficient to fit onto an outer surface of the distal end of the filament tube. (Item 32) Item 32. The vascular closure assembly of item 31, wherein the filament lock comprises between about 3 fingers and about 10 fingers. (Item 33) Item 13. The vascular closure assembly of item 12, wherein the actuator assembly further comprises a filament cutter disposed in operable alignment with the filaments of the individual plurality of anchor deployers. (Item 34) 1. An actuator assembly comprising: a chassis portion having an outer shell with an interior volume disposed within the outer shell; an elongated housing with an axial length that exceeds its lateral dimension, a proximal end secured to a distal end of the chassis portion, a distal end extending away from the chassis portion, an inner lumen extending along the elongated housing to the distal end of the elongated housing, a distal section, a filament lumen extending along the elongated housing and terminating at a distal port disposed in the distal section of the elongated housing, and a plurality of anchor deployer lumens, each anchor deployer lumen extending axially along the elongated housing and terminating distally at a distal port disposed in the distal section of the elongated housing; A plurality of anchor deployers, each anchor deployer being slidably disposed within a respective deployer lumen of the elongate housing and including a distal end configured to extend and diverge from a distal section of the outer housing, each anchor deployer comprising: a deployment rod including an elongated elastic configuration with an axial length that exceeds a lateral dimension and a distal end that extends from a distal section of the elongated housing in response to distal axial deployment; an anchor removably secured to a distal end of the deployment rod; a filament, the filament slidably disposed within a filament lumen of the elongated housing and including a distal end secured to the anchor; a plurality of anchor deployers, a filament locking mechanism disposed at a distal end of the filament lumen, the filament locking mechanism including a filament lock disposed in operative alignment with a filament of each of the plurality of anchor deployers; An actuator assembly comprising: (Item 35) 1. An anchor deployer actuator, comprising: an anchor deployer carrier slidably disposed relative to the chassis portion and operably coupled to a proximal section of each of the plurality of deployer rods; an actuator lever extending outside the chassis portion and operatively coupled to the anchor deployer carrier for distally translating the anchor deployer carrier in response to an actuation translation, thereby axially distally translating each of the deployer rods in response to an actuation translation; An anchor deployer actuator comprising: Item 35. The actuator assembly of item 34, further comprising: (Item 36) Item 35. The actuator assembly of item 34, wherein a distal section of each of the anchor deployer lumens comprises a curved profile relative to a longitudinal axis of the nominal anchor deployer lumen section disposed proximal to the distal section of the anchor deployer lumen to provide an outward angular deflection of the anchor deployer extending outward from a distal port of the anchor deployer lumen. (Item 37) Item 37. The actuator assembly of item 36, wherein the curved profile of the distal section of each of the anchor deployer lumens comprises a firing axis that forms an angle of about 15 degrees to about 35 degrees with respect to a longitudinal axis of the nominal anchor deployer lumen segment that is disposed proximal to the distal section of the anchor deployer lumen. (Item 38) Item 35. The actuator assembly of item 34, wherein a distal end of each of the anchor deployer lumens includes a recessed pocket having an inner surface configured to receive an outer surface contour of an individual anchor disposed therein with a close fit therebetween. (Item 39) Item 37. The actuator assembly of item 36, wherein the curved profile of the distal section of a first anchor deployer lumen comprises a firing axis that forms a first angle with respect to a longitudinal axis of the nominal anchor deployer lumen section that is disposed proximal to the distal section of the anchor deployer lumen, and the curved profile of the distal section of a second anchor deployer lumen comprises a firing axis that forms a second angle with respect to a longitudinal axis of the nominal anchor deployer lumen section that is disposed proximal to the distal section of the anchor deployer lumen, the second angle being different from the first angle. (Item 40) Item 35. The actuator assembly of item 34, wherein each anchor of the plurality of anchor deployers includes a sharp distal tip configured to penetrate distally into tissue. (Item 41) Item 35. The actuator assembly of item 34, wherein each deployment rod of the plurality of anchor deployers includes a sharp tissue-piercing tip disposed on a distal end of the deployment rod, and the anchor removably secured to the distal end of the deployment rod has a tubular configuration without a sharp distal tip. (Item 42) Item 35. The actuator assembly of item 34, further comprising a filament tensioning mechanism configured to controllably apply axial tension to filaments of the individual plurality of anchor deployers. (Item 43) Item 43. The actuator assembly of item 42, wherein the filament tensioning mechanism includes a filament end secured to a filament of the plurality of anchor deployers and a tension spring operably secured to the filament end, the filament end being translatable from a first position in which no tension is applied to the filament by the filament end to a second position in which the tension is applied to the filament through the filament end by the tension spring. (Item 44) The filament locking mechanism includes: a filament tube having a distal section slidably disposed within a close-fitting bore in a distal section of the elongated housing, the filament tube having a distal end extending distally beyond a distal shoulder surface of the close-fitting bore, the filament tube having an inner lumen slidably disposed relative to the elongated housing and disposed about the filament, and a proximal section; a filament lock having an inner lumen centered about the distal end of the filament tube at an axial location distal to a distal shoulder surface of the close-fitting bore, the filament lock being configured to self-contract from an expanded state to a relaxed state and to crimp onto the filament disposed within the inner lumen of the filament tube once an outward radial support producing an expanded state of the filament tube is removed; a filament tube actuator operably coupled to a proximal section of the filament tube and configured, upon activation, to push the filament lock from a distal end of the filament tube and axially retract the filament tube against the distal shoulder surface to allow the filament lock to crimp onto the filament disposed within an inner lumen of the filament tube; Item 35. The actuator assembly of item 34, comprising: (Item 45) Item 45. The actuator assembly of item 44, wherein the filament lock comprises a coiled spring filament, the inner lumen being sized to crimp onto the filament disposed therein when in a contracted state, and the inner lumen being capable of being elastically expanded to a lateral dimension sufficient to fit onto an outer surface of a distal end of the filament tube. (Item 46) Item 45. The actuator assembly of item 44, wherein the filament locking portion comprises a tubular structure including a main body portion and including a plurality of fingers extending proximally from the main body portion, the fingers being of sufficient axial length and resiliently biased toward a central longitudinal axis of the main body portion such that when the fingers are in the relaxed state, individual distal ends of the fingers are configured to self-contract from an expanded state to a relaxed state and crimp onto the filament disposed within an inner lumen of the filament locking portion, the fingers being resiliently biased toward a central longitudinal axis of the main body portion, the fingers being resiliently spreadable in relative lateral separation to an expanded state sufficient to fit onto an outer surface of a distal end of the filament tube. (Item 47) Item 35. The actuator assembly of item 34, further comprising a filament cutter disposed in operative alignment with the filaments of the individual plurality of anchor deployers. (Item 48) Item 48. The actuator assembly of item 47, wherein the filament comprises a suture, and the filament cutter comprises a suture cutter, the suture cutter including a sharp blade angled toward the suture and disposed within a slider configured to translate laterally within a bore relative to the suture such that the blade approaches the suture to contact and cut therethrough prior to completion of a corresponding lateral actuation stroke. (Item 49) 1. A catheter assembly comprising: an elongate shaft including a proximal end, a distal end, and a distal section; a proximal chassis secured to a proximal end of the elongated shaft; a self-inflating balloon disposed on a distal section of the shaft, the self-inflating balloon including a thin compliant shell material and an interior volume in fluid communication with a balloon inflation lumen, the balloon inflation lumen extending from an inflation port disposed in fluid communication with the interior volume of the self-inflating balloon along the elongate shaft to an inlet port disposed on the elongate shaft at an axial location distal to a distal end of the self-inflating balloon; a balloon inflation valve configured to controllably open and close the balloon inflation lumen; A catheter assembly comprising: (Item 50) 50. The catheter assembly of claim 49, further comprising a foot extension disposed on the elongate shaft within the interior volume of the self-inflating balloon, the foot extension configured to extend outward from a retracted position in which the foot is disposed substantially within a nominal outer contour of the shaft to a deployed position in which an outer end of the foot extension extends radially outward from a nominal outer contour of the shaft generally perpendicular to a longitudinal axis of the elongate shaft. (Item 51) Item 51. The catheter assembly of item 50, further comprising a leg extension actuator configured to change the state of the leg extension between the retracted position and the deployed position. (Item 52) 50. The catheter assembly of claim 49, further comprising a blood return lumen extending proximally from a distal end of the elongate shaft to a proximal port of the blood return lumen disposed proximally of the self-inflating balloon. (Item 53) 50. The catheter assembly of claim 49, further comprising a guidewire lumen extending along the elongate shaft to a distal guidewire port disposed at a distal end of the elongate shaft. (Item 54) 1. A filament locking portion comprising a tubular structure with a main body portion and a plurality of fingers extending proximally from the main body portion, the fingers being of sufficient axial length such that when the fingers are in the relaxed state, individual distal ends of the fingers are configured to self-contract from an expanded state to a relaxed state and to crimp onto a filament disposed within an inner lumen of the filament locking portion, the fingers being resiliently biased toward a central longitudinal axis of the main body portion, the fingers being resiliently biased toward a relative lateral separation to the expanded state. (Item 55) Item 55. The vascular closure assembly of item 54, wherein the filament lock comprises between about 3 fingers and about 10 fingers. (Item 56) 1. A method for vascular closure, comprising: advancing a vascular closure assembly distally toward an access hole in a blood vessel and a passageway disposed in a tissue layer adjacent to the blood vessel while an inner catheter assembly of the vascular closure assembly is disposed within an inner lumen of an elongated housing of the vascular closure assembly with an inflatable balloon of the inner catheter assembly extending distally beyond the distal end of the elongated housing; inflating the inflatable balloon until contact and hemostasis are established between an outer surface of the inflatable balloon and a surrounding surface of an access hole in the blood vessel; axially translating the actuator assembly over the inner catheter assembly while holding the inner catheter assembly in a fixed axial position relative to an access hole in the blood vessel until a distal end of an elongated housing of the actuator assembly is positioned adjacent the passage in the tissue layer; deploying a plurality of anchor deployers in a distal and radially outward direction away from a distal section of an elongate housing of the vascular closure assembly with an anchor deployer actuator to engage the tissue layer with individual anchors of the plurality of anchor deployers at fixed locations centered about the passageway in the tissue layer; pulling the anchors closer together by applying proximal tension to the filaments secured to each of the anchors so as to pull together the anchors and the individual portions of the tissue layer secured to each of the anchors, thereby reducing a lateral dimension of a passage in the tissue layer; deploying a filament lock onto the filament at a distal end of the elongated housing by activating the filament locking mechanism while maintaining tension on the filament with the tension spring; A method comprising: (Item 57) 57. The method of claim 56, wherein distally advancing the vascular closure assembly comprises distally advancing the vascular closure system over a guidewire. (Item 58) 58. The method of claim 57, wherein advancing the vascular closure assembly distally over the guidewire comprises advancing the vascular closure assembly distally while an inner catheter assembly is releasably secured to the actuator assembly to prevent relative axial displacement therebetween. (Item 59) 57. The method of claim 56, further comprising deploying the leg extensions from an elongate shaft of the inner catheter assembly from a position within the interior volume of the inflatable balloon such that the leg extensions extend radially outward from the elongate shaft. (Item 60) 60. The method of claim 59, further comprising retracting the vascular closure assembly proximally until contact between the foot extensions and an inner surface of the patient's blood vessel adjacent the access hole prevents further proximal displacement and an axial length of the inflatable balloon overlaps the access hole. (Item 61) Item 61. The method of item 60, wherein the inflatable balloon comprises a self-inflating balloon, and inflating the self-inflating 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 and into an interior volume of the self-inflating balloon. (Item 62) 57. The method of claim 56, wherein deploying the plurality of anchor deployers in a distal and radially outward direction away from a distal section of the elongate housing includes deploying the plurality of anchor deployers in an asymmetric pattern about a longitudinal axis of the elongate housing. (Item 63) 57. The method of claim 56, further comprising anchoring the anchors to the tissue layer at locations centered about the passageways in the tissue layer during deployment of the plurality of anchor deployers. (Item 64) Item 64. The method of item 63, wherein anchoring the anchors to the tissue layer at locations centered about the passage in the tissue layer includes penetrating the tissue layer with each of the anchors of the individual anchor deployers and detaching each anchor from its individual deployment rod at a location beneath the tissue layer. (Item 65) 57. The method of claim 56, further comprising rotating the actuator assembly after deploying the anchor deployer until a longitudinal axis of the elongated housing is approximately perpendicular to a longitudinal axis of the blood vessel prior to proximally retracting a deployment rod of the anchor deployer. (Item 66) 57. The method of claim 56, further comprising, after deploying the plurality of anchor deployers, retracting deployment rods of the anchor deployers proximally into the elongated housing by releasing the anchor deployer actuator. (Item 67) 57. The method of claim 56, wherein applying proximal tension to the filament secured to each of the anchors comprises actuating a filament tensioning mechanism configured to controllably apply tension to the filament. (Item 68) Item 68. The method of item 67, wherein actuating the filament tensioning mechanism includes controllably translating the filament and a filament end that is affixed to a tension spring. (Item 69) 57. The method of claim 56, wherein activating the filament locking mechanism includes depressing a filament tube actuator coupled to a filament tube positioned about the filament within the outer housing, thereby retracting the filament tube proximally and pushing at least one filament lock in an extended state from a distal end of the filament tube and onto the filament. (Item 70) 70. The method of claim 69, further comprising: the filament lock comprises a self-contracting configuration, and once the outward radial support of the filament tube is removed by retracting the distal end of the filament tube proximally past a distal shoulder of a close-fitting bore centered about the distal end of the filament tube, the self-contracting filament lock contracts over the filament to a relaxed state, thereby allowing the at least one filament lock to be crimped onto the filament and to each other. (Item 71) 57. The method of claim 56, further comprising severing the filament proximal to the deployed filament lock by actuating a filament cutter of the actuator assembly disposed in operable alignment with the filament. (Item 72) Item 57. The method of item 56, wherein a sharp blade of the filament cutter is disposed within a slider, and actuating the filament cutter of the actuator assembly includes translating the slider and sharp blade within a bore relative to the filament and approaching the filament during lateral translation to contact the filament, thereby cutting through the filament. (Item 73) 1. A vascular closure device comprising: a filament lock comprising a tubular structure with a main body portion and a plurality of fingers extending proximally from the main body portion, the fingers being of sufficient axial length and resiliently biased toward a central longitudinal axis of the main body portion such that when the fingers are in the relaxed state, individual distal ends of the fingers are configured to self-contract from an expanded state to a relaxed state and to crimp onto the filament disposed within an inner lumen of the filament lock, the fingers being resiliently biased toward a central longitudinal axis of the main body portion, the fingers being resiliently spread apart 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 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 lock; a filament tube actuator configured to axially withdraw the filament tube from within the inner lumen of the filament lock; A vascular closure assembly comprising: (Item 74) Item 74. The vascular closure assembly of item 73, wherein the filament lock comprises between about 3 fingers and about 10 fingers. (Item 75) Item 75. The vascular closure assembly of item 74, wherein the filament lock comprises about 4 fingers to about 6 fingers. (Item 76) Item 74. The vascular closure assembly of item 73, wherein the filament lock comprises a superelastic material. (Item 77) Item 77. The vascular closure assembly of item 76, wherein the superelastic material of the filament lock comprises a nickel titanium alloy. (Item 78) 1. A method for vascular closure, comprising: advancing an actuator assembly distally until a distal end of an elongated housing of the actuator assembly is disposed adjacent the passage in the tissue layer; deploying a plurality of anchor deployers distally and radially outwardly from the elongate housing in an asymmetric pattern about a longitudinal axis of the elongate housing and engaging the tissue layer with individual anchors of the plurality of anchor deployers at fixed positions disposed in the asymmetric deployment pattern about a passage in the tissue layer; pulling the anchors closer together by applying tension to a filament secured to each of the individual anchors so as to pull together the anchors and individual portions of the tissue layer secured to each of the anchors, thereby reducing a lateral dimension of a passage in the tissue layer; deploying a filament lock onto the filament at a distal end of the elongated housing while maintaining tension on the filament; A method comprising: [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 is a perspective view of an embodiment of a vascular closure assembly including an actuator assembly and an inner catheter assembly.

[0014] [Diagram 2] 2 is a perspective view of an inner catheter assembly embodiment of the vascular closure assembly of FIG. 1. FIG.

[0015] [Diagram 3] 3 is a cut away view of an actuator assembly embodiment of the vascular closure assembly of FIG. 1. FIG.

[0016] [Figure 4] 4 is a transverse cross-sectional view of the actuator assembly of FIG. 3 taken along line 4-4 of FIG.

[0017] [Diagram 5] FIG. 5 is a partial cutaway view of a chassis portion of the actuator assembly of FIG. 1 showing an angular alignment mechanism embodiment and an inner lumen of the actuator assembly.

[0018] [Figure 6] 6 is a partial perspective view of the actuator assembly of FIG. 1 showing the filament cutter in an undeployed state.

[0019] [Figure 7] 7 is an enlarged elevational view of an inner catheter assembly position lock embodiment disposed on the proximal end of the chassis portion of the actuator assembly of FIG. 1, including a cam lock arrangement.

[0020] [Figure 8] FIG. 8 is an enlarged partial cross-sectional elevational view showing an embodiment of an inner catheter assembly position lock embodiment including a collet type configuration.

[0021] [Figure 9] 9 is a transverse cross-sectional view of the inner catheter assembly of FIG. 1 taken along line 9-9 of FIG.

[0022] [Figure 10] 10 is a transverse cross-sectional view of the inner catheter assembly of FIG. 1 taken along line 10-10 of FIG.

[0023] [Figure 11] 11 is a longitudinal cross-sectional view of the proximal chassis of the inner catheter assembly of FIG. 2 taken along line 11-11 of FIG. 2.

[0024] [Figure 12] FIG. 12 is a cutaway view of the actuator assembly of FIG. 1 shown with an anchor deployer embodiment deployed into a tissue layer disposed above and adjacent to a patient's blood vessel.

[0025] [Figure 12A] FIG. 12A is a schematic diagram in elevation of an actuator assembly embodiment, including a spring-powered anchor deployer actuator embodiment.

[0026] [Figure 13] FIG. 13 is an elevational view of an anchor deployer carrier embodiment secured to the proximal ends of multiple deployment rods.

[0027] [Figure 14] FIG. 14 is a cutaway view of an actuator assembly embodiment of the vascular closure assembly of FIG. 1 shown with the filament tensioning mechanism partially activated and the filament partially tensioned.

[0028] [Figure 15] 15 is a longitudinal cross-sectional view of the filament tensioning mechanism embodiment of the actuator assembly embodiment of FIG. 14 taken along line 15-15 of FIG.

[0029] [Figure 16] 16 is a transverse cross-sectional view of the filament tensioning mechanism embodiment of FIG. 15 taken along line 16-16 of FIG.

[0030] [Figure 17] 17 is a partial cutaway view of a perspective view of the actuator assembly of FIG. 1 illustrating a tension spring and filament cutter embodiment of the filament tensioning mechanism.

[0031] [Figure 18] 18 is a close-up view of the filament cutting mechanism of the actuator assembly embodiment of FIG. 17.

[0032] [Figure 19] FIG. 19 shows a distal section of the elongated housing of the actuator assembly of FIG. 1 illustrating the firing axis angle of one of the anchor deployer lumens of the actuator assembly.

[0033] [Figure 20] FIG. 20 is a cross-sectional elevation view of a tissue layer positioned across two blood vessels of a patient, including an artery and a vein, and a distal section of an elongated housing embodiment of the actuator assembly positioned adjacent to and engaged with the tissue layer with the anchor deployer of the actuator assembly in a deployed state.

[0034] [Figure 20A] FIG. 20A is a schematic diagram of a deployment pattern embodiment.

[0035] [Figure 21] 21 is a longitudinal cross-sectional elevation view of a distal section of an elongated housing of the actuator assembly of FIG. 1. FIG.

[0036] [Figure 22] 22 is a cutaway view of a chassis portion of the actuator assembly of FIG. 1 illustrating a filament tube actuator embodiment affixed to a proximal portion of the filament tube.

[0037] [Figure 23] FIG. 23 is an elevational view of a filament lock embodiment.

[0038] [Figure 24] 24 is a transverse cross-sectional view of the filament embodiment of FIG. 23 taken along line 24-24 of FIG.

[0039] [Diagram 25] FIG. 25 is an elevational view of another filament lock embodiment.

[0040] [Figure 26] 26 is a longitudinal cross-sectional elevation view of the filament lock of the embodiment of FIG. 25 taken along line 26-26 of FIG.

[0041] [Figure 27] 27 is a transverse cross-sectional view of the filament lock of the embodiment of FIG. 25 taken along line 27-27 of FIG.

[0042] [Figure 28] FIG. 28 illustrates the filament lock embodiment of FIG. 27 in an expanded state.

[0043] [Figure 29] FIG. 29 is a perspective view of a distal section of an anchor deployer embodiment.

[0044] [Diagram 30] FIG. 30 is a perspective view of a distal section of another anchor deployer embodiment.

[0045] [Diagram 31] 31 is a perspective view of a distal portion of a deployment rod embodiment of the anchor deployer of FIG. 30. FIG.

[0046] [Diagram 32] 32 is a transverse cross-sectional view of the deployment rod embodiment and anchor embodiment of the anchor deployer of FIG. 30 taken along line 32-32 of FIG.

[0047] [Diagram 33] FIG. 33 is a perspective view of a distal portion of an anchor deployer embodiment, including a deployment needle.

[0048] [Diagram 34] 34 is a longitudinal cross-sectional elevation view of the anchor deployer of FIG. 33 taken along line 34-34 of FIG.

[0049] [Diagram 35] FIG. 35 is an elevational view of the distal section of an inner catheter assembly embodiment.

[0050] [Diagram 36] FIG. 36 is an enlarged longitudinal cross-sectional view of a distal portion of an inner catheter assembly embodiment shown with the balloon inflation lumen in an open state for self-inflation of the self-inflating balloon.

[0051] [Figure 37] FIG. 37 shows the inner catheter assembly embodiment of FIG. 36 with the balloon inflation lumen in a closed state, preventing self-inflation of the self-inflating balloon and, optionally, allowing venting of the interior volume of the self-inflating balloon.

[0052] [Figure 38] FIG. 38 is an enlarged longitudinal cross-sectional elevation view of a distal portion of an inner catheter assembly embodiment with its self-inflating balloon embodiment in an uninflated state and its foot extensions in a retracted state.

[0053] [Figure 39] FIG. 39 shows the inner catheter assembly embodiment of FIG. 38 with the self-inflating balloon in an inflated state and its leg extensions in an outwardly extended state after its deployment.

[0054] [Diagram 40] FIG. 40 is an enlarged longitudinal cross-sectional view of a distal portion of an embodiment of an inner catheter assembly shown with its balloon inflation lumen in a closed state, preventing inflation of the self-inflating balloon and, optionally, allowing venting of the internal volume of the self-inflating balloon.

[0055] [Diagram 41] FIG. 41 shows the inner catheter assembly embodiment of FIG. 40 with the balloon inflation lumen in an open state for inflation of its self-inflating balloon.

[0056] [Diagram 42] FIG. 42 is an end view of the optional leg extension housing portion of the elongate shaft of an inner catheter assembly embodiment.

[0057] [Diagram 43] 43 is a longitudinal cross-sectional elevation view of the foot extension housing portion of FIG. 42 taken along line 43-43 of FIG.

[0058] [Diagram 44] FIG. 44 is a perspective view of a foot extension embodiment.

[0059] [Diagram 45] 45 is an underside perspective view of the foot extension embodiment of FIG. 44 operably coupled to and extending outwardly from the foot extension housing portion of FIG. 43. FIG.

[0060] [Figure 46] 46 is a perspective view of a distal section of the elongated housing of the actuator assembly of FIG. 1 with its anchor deployer deployed into a tissue layer positioned above a patient's blood vessel.

[0061] [Figure 47] FIG. 47 is a perspective cutaway view of an embodiment of a patient's blood vessel, including an arterial segment and a venous segment.

[0062] [Figure 48] FIG. 48 is a transverse cross-sectional view of the patient's blood vessel of FIG. 47 taken along line 48-48 of FIG.

[0063] [Figure 49] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 50] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 50A]49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 51] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 52] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 53] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 54] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 55] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 56] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 57] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 58] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 59] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 60] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG. [Figure 61] 49-61 illustrate an embodiment of a vascular closure method utilizing the vascular closure assembly embodiment of FIG.

[0064] The drawings are intended to illustrate certain example embodiments, but not to be limiting. 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 an understanding of particular embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0065] Detailed Description As discussed above, after a percutaneous catheter placement procedure or any other procedure that requires vascular access using an access hole in a patient's blood vessel, a physician must typically address the issue of bleeding from the vascular access hole once the therapeutic or diagnostic device or devices are removed from the access hole in the patient's blood vessel. Some suitable device and method embodiments for such procedures are discussed in U.S. patent application Ser. No. 15 / 277,542 (now U.S. Patent No. 10,639,020), filed Sep. 27, 2016 and issued May 5, 2020, entitled "VASCULAR CLOSURE DEVICE," by Thomas Larzon, et al., U.S. patent application Ser. No. 16 / 190,654, filed Nov. 14, 2018, entitled "COLLAPSIBLE TUBE FOR HEMOSTASIS," by Thomas Larzon, et al., and U.S. patent application Ser. No. 16 / 190,694, filed Nov. 14, 2018, entitled "TISSUE CLOSURE DEVICE," 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. In addition, 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 closure assemblies discussed herein may be useful for addressing 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 may include two primary components, directed to an actuator assembly (which may optionally include 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 interior 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 closure procedure. Although the inner catheter assembly is frequently discussed herein as a component of the vascular closure assembly, in some cases such inner catheter assembly embodiments may function as a stand-alone catheter assembly having the same or similar features, dimensions, and materials. Actuator embodiments may include multiple anchor deployers and associated anchors, including four or more such anchor deployers and associated anchors, or any other suitable number of anchor deployers with filaments, such as sutures, each having a distal end secured to one of the multiple anchors. The anchors may be embedded and / or engaged within the tissue layer at locations circumferentially positioned about the access hole in the vessel by a deployment rod actuated by an actuator lever on the actuator assembly. The actuator assembly may also include a spring to apply tension to the filament and close the access hole, and a filament lock to hold the filament in place once the connection to the actuator assembly is severed.

[0067] In general, during use of such embodiments, operation of the device embodiment to close the access hole may begin once the basic therapeutic or diagnostic procedure is completed, generally while the guidewire used for the procedure is still in place. The actuator assembly, along with the inner catheter assembly, may first be 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 (while hemostasis is maintained via manual compression). A lever may then be activated to deploy the foot extension, and the actuator assembly and inner catheter assembly are pulled proximally until the foot extension engages the anterior wall of the blood vessel. Another lever may then be actuated to open the balloon inflation valve, allowing 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 may then be slid distally over the inner catheter assembly until aligned with the insertion alignment mark, thereby positioning the nose of the actuator assembly the correct distance from the blood vessel to the tissue layer, e.g., fascia layer, disposed above the vessel. The actuator lever on the actuator assembly may then be pulled, deploying the anchor deployer and associated anchor. Filament tension may then be applied by turning the large knob at the base of the actuator assembly. The inflatable balloon may then be withdrawn, allowing the filament tension to completely close the access hole. Finally, the filament lock may be deployed by pulling the small lever on the actuator assembly, and the suture filament may be cut by depressing the filament cutter button on the proximal side of the actuator assembly. The device may now be slid off the guidewire, and the skin wound may be closed in standard fashion.

[0069] 1-6, an embodiment of a vascular closure assembly 10 that may be used for such a vascular closure procedure may include an actuator assembly 12 having a chassis portion 14 with an outer shell 16 and an interior volume 18 disposed within the outer shell 16. The actuator assembly 12 may further include an elongated housing 22 having an axial length that exceeds its lateral dimension, a proximal end 24 secured to a distal end 26 of the chassis portion 14, and a distal end 28 extending away from the chassis portion 14. The elongated housing 22 also includes an inner lumen 32 that extends along the elongated housing 22 to the distal end 28 of the elongated housing 22, as shown in FIG. 4, a distal section 34, and a filament lumen 36 that extends along the elongated housing 22, as shown in FIG. 4, and is disposed within a filament tube 37 that terminates at a distal port 38 that is disposed within the distal section 34 of the elongated housing 22, as shown in FIGS. 19-21. The elongated housing 22 further includes a number of anchor deployer lumens 42. Each anchor deployer lumen 42 may extend axially along a curved or straight path along the elongated housing 22 and terminate distally at a distal port 44 disposed within the distal section 34 of the elongated housing 22. In some cases, a handle portion 46 of the actuator assembly 12 may have an upper end 48 that is secured to the chassis portion 14.

[0070] The actuator assembly 12 may also include multiple anchor deployers 52, as shown in FIG. 4, each anchor deployer slidably disposed within a respective anchor deployer lumen 42 of the elongated housing 22 and including a distal end 54 configured to extend and diverge in a distal and radially outward orientation from the distal section 34 of the elongated housing 22, as shown in FIG. 29. For some embodiments, each anchor deployer 52 may include a deployment rod 56 having an elongated resilient configuration with an axial length that exceeds the lateral dimension and a distal end 58 that extends from the distal section 34 of the elongated housing 22 upon distal axial deployment. An 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 mate with the distal end 58 of the deployment rod 56 such that distally directed forces from the distal end 58 of the deployment rod 56 are easily transferred to the anchor 62. However, the anchor 62 may also be configured to resist proximal retraction within the tissue 64 once deployed, such that the distal end 58 of the deployment rod 56 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, as shown in FIG. 46 . The filament 66 is slidably disposed within the filament lumen 36 of the elongated housing 22 and may include a distal end 68, which is secured to the anchor 62. Additionally, the actuator assembly 12 may include a filament locking mechanism 72 disposed at a distal end 74 of the filament lumen 36 and filament tube 37, as shown in FIG. 21, the filament locking mechanism 72 including a filament locking portion 76 disposed in operable alignment with the filaments 66 of the individual anchor deployers 52.

[0071] Some embodiments of the vascular closure assembly may also include an inner catheter assembly 78. The inner catheter assembly 78 may have an elongate shaft 82 including a proximal end 84, a distal end 86, a distal section 88, and an axial length sufficient for the distal section 88 to extend distally beyond the distal end 28 of the elongate housing 22 when disposed within its inner lumen 32. The inner catheter assembly 78 may further include an outer surface contour configured to be slidably disposed within the inner lumen 32 of the elongate housing 22. A proximal chassis 92 may be affixed 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-inflating balloon 94, may be disposed on the distal section 88 of the elongate shaft 82 at an axial location that may extend distally from the distal end 28 of the elongate housing 22 when the elongate shaft 82 is disposed within the inner lumen 32 of the elongate housing 22. 9 and 10, the self-inflating balloon 94 may include a wall portion 96 made from a thin compliant material and an interior volume 98 in communication with a balloon inflation lumen 102. The self-inflating balloon 94 may also have an exterior contour configured to be slidably disposed within the inner lumen 32 of the elongated housing 22 when the self-inflating balloon 94 is in a deflated state.

[0072] The balloon inflation lumen 102 may extend along the elongated shaft 82 from an inflation port 104 disposed in fluid communication with the interior volume 98 of the self-inflating balloon 94 to an inlet port 106 disposed on the elongated shaft 82 at an axial location distal to the distal end 108 of the self-inflating balloon 94, as shown in Figures 35 and 36. Such inner catheter assembly embodiments 78 may also have a balloon inflation valve 112 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, although 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 indications, including providing hemostasis during procedures other than vascular closure procedures, such as coronary artery bypass graft procedures, as well as others.

[0073] The inner catheter assembly 78 of the vascular closure assembly 10 may further include a guidewire lumen 114, as shown in Figures 9 and 10, which extends along the elongated shaft 82 to a distal guidewire port 116 disposed at the distal end 86 of the elongated shaft 82 and accommodates a guidewire 117, as shown in Figures 35 and 36. The inner catheter assembly 78 may further include a blood return lumen 118, as shown in Figures 9 and 10. The blood return lumen 118 may extend proximally from a distal port 120, disposed on the distal section 88 of the elongated shaft 82, to a proximal port 122 of the blood return lumen 118, disposed on the proximal chassis 92, as shown in Figure 2. The distal port 120 may be disposed on the distal section 88 of the elongated shaft 82 at an axial location proximal to the self-inflating balloon 94, as also shown in Figure 2. For embodiments of the inflatable balloon 94 that are not configured to be self-inflating, the balloon inflation lumen may be positioned to be in fluid communication with an inflation pressure source (not shown), such as a syringe or other inflation pump, rather than with the inlet port 106.

[0074] For some embodiments, the self-inflating balloon 94 may have an outer profile that is sized in a transverse dimension to fit within the inner lumen 32 of the elongated housing 22 and configured to self-expand in a transverse dimension from a compressed state to an inflated state with an outer transverse dimension greater than the outer transverse dimension of the elongated shaft 82. The self-inflating balloon 94 in the inflated state may also be sized and configured in a transverse dimension to completely fill and plug an access hole 124 disposed within a wall portion 126 of a patient's blood vessel 128. The self-inflating balloon 94 may further include an outer profile having an elongated shape or profile such that in the inflated state, a nominal axial length of the self-inflating balloon 94 exceeds a transverse dimension of the self-inflating balloon 94 when in the inflated state. In some cases, the self-inflating balloon 94 in the inflated state may have an outer transverse dimension of about 8 mm to about 15 mm and a nominal axial length of about 10 mm to about 25 mm. In some cases, the wall portion 96 of the self-inflating balloon 94 may have a thickness of 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 instances, it may be desirable to control the inflation of the self-inflating balloon 94. Thus, the balloon inflation valve 112 may be configured to reversibly open and close the balloon inflation lumen 102 and control the rate of blood flow therethrough. Some embodiments of the balloon inflation valve 112 may include an obturator 134 having an outer surface contour 136 that is matched to an inner surface contour 138 of the balloon inflation lumen 102 to prevent the flow of fluids such as blood therethrough, as shown in FIGS. 9, 10, 36, and 37. This configuration also allows the obturator 134 to be slidably positioned 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 secured to the obturator 134 and a proximal end 146 operably coupled or otherwise secured 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 obturator 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 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 located on the elongate shaft 82 distal to the distal end 108 of the self-inflating balloon 94 .

[0076] In some cases, during deployment of the self-inflating balloon 94, the self-inflating balloon 94 may fill with fluid, such as blood, from within the interior 150 of the blood vessel 128 and significantly expand, assuming a mushroom-shaped configuration, with the expanded head of the mushroom configuration of the self-inflating balloon 94 disposed outside the blood vessel 128 adjacent the access hole 124 in the blood vessel 128. Such expansion of the outer surface 154 of the self-inflating balloon 94 may increase friction between the surrounding surface 156 of the access hole 124 in the blood vessel 128 and the outer surface 154 of the self-inflating balloon 94. In some instances, this increased friction may in turn impede axial movement of the self-inflating balloon 94 relative to the access hole 124 as well as other structures, such as movement of the inner catheter assembly 78 within the interior lumen 150 of the blood vessel 128. Additionally, in some cases, the self-inflating balloon 94 may become trapped upon withdrawal within the distal end 158 of the inner lumen 32 of the elongated housing 22 of the actuator assembly 12. Accordingly, it may be useful to provide a venting feature with respect to the interior volume 98 of the self-inflating balloon 94 that provides fluid communication between the interior volume 98 of the self-inflating balloon 94 and ambient pressure, the venting feature being disposed about the inner catheter assembly 78 of the vascular closure assembly 10 outside the interior lumen 150 of the blood vessel 128 being treated. Such venting may be performed while the balloon inflation lumen 102, typically disposed between the ports 104 and 106, is in a closed state that prevents flow therethrough.

[0077] Given the foregoing, for some embodiments, there may be a portion of the balloon inflation lumen 102 of the elongated shaft 82 that extends proximally to the balloon inflation port 104, and this proximal portion may be vented to the outside atmosphere. For such embodiments, when the obturator 134 of the balloon inflation valve 112 is positioned distal to the balloon inflation port 104 with fluid communication between the inlet port 106 and the inflation port 104 blocked, the inflation port 104 may thus be vented to the outside ambient atmosphere by the proximal portion of the balloon inflation lumen 102 to allow the interior volume 98 of the self-inflating balloon 94 to vent and contract to a collapsed state when not actively inflated. This arrangement may facilitate axial translation of the self-inflating balloon 94 within the vascular lumen 150 as well as axial withdrawal of the self-inflating balloon 94 into the inner lumen 32 of the elongated housing 22 when not actively inflated.

[0078] Alternatively, similar control of inflation of the self-inflating balloon 94 may be achieved using a balloon inflation valve embodiment 112 including cooperating pairs of lamellae (or tubular members with separate 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 venting 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 disposed such that one lamella, such as the first lamella 162, is seated closely together, optionally with the lamella fixed relative to the elongated shaft 82, but sufficiently loose such that the lamellae 162, 164 may move axially in the distal and proximal directions relative to one another. In one position (e.g., when the foot extensions 166 are retracted, as shown in FIG. 40), fluid communication between the vascular lumen 150 and the interior volume 98 of the self-inflating balloon 94 is blocked, but fluid communication between the interior volume 98 of the self-inflating balloon 94 and vent to the surrounding environment may be open. In a second position (e.g., when the foot extensions 166 are deployed, as shown in FIG. 41), fluid communication between the vascular lumen 150 and the interior volume 98 of the self-inflating balloon 94 is open, and fluid communication between the interior volume 98 of the self-inflating balloon 94 and the surrounding environment is closed or otherwise blocked.

[0079] Also, in some circumstances it may be useful to combine the functions of certain elements of the balloon inflation valve embodiment 112 and the foot 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 obturator 134, may also be used to actuate the deployment of the foot 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 extension 166 is simultaneously deployed by a distally extended portion (not shown) of the actuator rod 142 that is operably coupled to the foot extension 166.

[0080] For some embodiments of such balloon inflation valve embodiment 112, the mated lamellae 162, 164 may include or otherwise be made from the tubular valve member 174 and a portion of the balloon inflation lumen 102 of the elongate shaft 82, configured to be axially displaced relative to one another by axial displacement of the tubular valve member 174 relative to the elongate shaft 82. The tubular valve member 174 may also have a first port 176 and a second port 178, respectively, fluidly coupled to one another, positioned to be aligned with the inlet port 106 and the inflation port 104 of the elongate shaft 82 when the tubular valve member 174 is disposed in an open axial position, as shown in FIG. 41, and positioned out of alignment with the inlet port 106 and the inflation port 104 when the tubular valve member 174 is in a closed axial position, as shown in FIG. 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 venting from the interior volume 98 of the self-inflating balloon 94 to the surrounding atmosphere through a central lumen 181 of the tubular valve member 174, which may extend, 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 close fit with the inner surface contour 138 of the balloon inflation lumen 102 of the elongate shaft 82. Such a close fit may be tight enough to prevent the flow of liquids, such as blood, between the outer contour 182 and the inner contour 138, but spaced far enough apart to allow relative axial displacement between the tubular valve member 174 and the elongate shaft 82.

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

[0082] For some embodiments, the foot extensions 166 may be positioned about an axial midpoint 194 of the self-inflating balloon 94 to help ensure overlap between the outer surface 154 of the self-inflating balloon 94 and the surrounding surface 156 of the access hole 124 when the self-inflating balloon 94 is deployed. For other embodiments, the foot extensions 166 may be positioned distal to the axial midpoint 194 of the self-inflating balloon 94 and proximal to the distal end 108 of the self-inflating balloon 94. For yet other embodiments, the foot extensions 166 may be positioned proximal to the axial midpoint 194 of the self-inflating balloon 94 and distal to the proximal end 196 of the self-inflating balloon 94, as shown in the embodiment of FIGS. 38 and 39 .

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

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

[0085] For some embodiments, the actuator assembly 12 may further include an inner catheter assembly position lock 212, as shown in FIG. 7. In some cases, the inner catheter assembly position lock 212 may be configured to apply a frictional force to an outer surface 214 of the elongated shaft 82 of the inner catheter assembly 78 while the inner catheter assembly 78 is disposed within the inner lumen 32 of the elongated housing 22. This controllable application of frictional force between the inner catheter assembly position lock 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 translate the actuator assembly 12 axially with the inner catheter assembly 78, such as when the vascular closure assembly 10 is initially advanced into a position adjacent the access hole 124 in the blood vessel 128 as well as the passageway 216 in the tissue layer 64 shown in FIG. 46 disposed above the access hole 124. For some embodiments, the inner catheter assembly position lock 212 may include a pivot lever 218 having an offset cam 222 configured to penetrate into the nominal contour of the inner lumen 32 of the elongated housing 22 when disposed in the locked position with a degree of inward radial penetration 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. In addition, the offset cam 222 of the pivot lever 218 may also be configured to overcome the nominal contour of the inner lumen 32 when disposed in the 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 lock may also include a collet type inner catheter assembly position lock 212', as shown in Figure 8. For such an embodiment 212', a threaded cap 219 may include a tapered bore 220 that mates with an outer end of a flexible slotted sleeve 221 having an inner lumen disposed therethrough that is sized to allow passage of the elongated 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.

[0087] When determining the relative axial position between the inner catheter assembly 78 and the actuator assembly 12, it may be useful to have predetermined reference points on each of these structures that are easily identifiable by a user. For example, in some cases, the elongated shaft 82 may include an insertion alignment mark 224 disposed on its outer surface 214 that is visually identifiable by a user, as shown in FIG. 2. The actuator assembly 12 may include a cooperating proximal index 226 that is visually identifiable by a user, as shown in FIG. 7. For such an embodiment, the axial position of the deployed foot extension 166, and more specifically, the axial position of the "v" shaped notch formed between the deployed foot extension 166 and the elongated shaft 82 on the proximal side of the foot extension 166 in the deployed state (see FIGS. 39, 41, and 45), may be spaced a predetermined axial separation from the distal end 28 of the elongated housing 22 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, and more specifically, from about 270 mm to about 275 mm.

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

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

[0090] A ball bearing 248 or similar spherical structure may be disposed within the conical cavity 236. The ball bearing 248 may be sized to rotate freely on an inner surface 252 of the conical cavity 236 and remain centered with the axis of symmetry 238 unless the axis of symmetry 238 deviates from an angular position that is horizontal and perpendicular at an angle that exceeds the cone angle 246 of the conical cavity 236. In other words, when the angular orientation of the angular alignment mechanism 232 is correct, the ball bearing 248 seats in the center of the conical cavity 236, as shown in FIG. 5. If the alignment is not correct, gravity will cause 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, for the embodiment shown, the axis of symmetry 238 and the longitudinal axis 244 are substantially coplanar.

[0091] The angle alignment mechanism 232 may include a window 254 disposed across the conical cavity 236 to prevent escape of the ball bearing 248 while still allowing for visualization thereof. Embodiments of the angle alignment mechanism 232 may be specifically designed to be compatible with various sterilization methods, such as electron beam and ethylene oxide (EtO), some of which may not be suitable for conventional level alignment fixtures. For some embodiments, the cone angle 246 may be between about 5 degrees and 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 between about 15 degrees and about 25 degrees.

[0092] Once the actuator assembly 12 and its elongated housing 22 are properly positioned, deployment of the plurality of anchor deployers 52 may be performed by a variety of mechanisms and methods, including an anchor deployer actuator 256, as shown in Figures 3, 12, and 13. For some embodiments, the anchor deployer actuator 256 of the vascular closure assembly 10 may include an anchor deployer carrier 258, which is slidably disposed relative to the chassis portion 14 and operably coupled to a proximal section 262 of each of the plurality of deployer rods 56, as shown in Figure 13. An actuator lever 264 may extend outside the chassis portion 14 of the outer shell 16 and operably coupled to the anchor deployer carrier 258 for distally translating the anchor deployer carrier 258 in response to an actuation translation. Such axial translation of the anchor deployer carrier 258 from a start position, in which the anchors 62 of the anchor deployer 52 are disposed substantially within the nominal outer surface contour 266 of the elongated housing 22, will axially translate each of the deployer rods 56 and associated anchors 62 in a distal and radially outward direction from the elongated housing 22 in response to the actuation translation, as shown in FIG. 12. In some cases, the actuator lever may be manually operated such that a manually applied compression exerted on the actuator lever 264 is translated 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 be configured to resist the manually applied actuation translation of the actuator lever 264 and / or the anchor deployer carrier 258 and return the actuator lever 264 and the anchor deployer carrier 258 from the displaced position to their start position.

[0093] Although 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, any number of other suitable devices and methods may be used to provide the distally directed force and deploy the anchor deployer 52. In some cases, a compressed spring, such as a deployment spring 275 contained 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, an anchor deployer carrier 258' may be operably coupled to the deployment spring 275 and the respective proximal section 262 of the deployer rod 56. An actuator lever 264' is configured to be operably coupled to the anchor deployer carrier 258' to maintain the deployment spring 275 in a compressed state until an operator is ready to deploy the anchor deployer 52. Once depressed or otherwise actuated, the actuator lever 264' releases the anchor deployer carrier 258' such that the deployment spring 275 is released from its axially compressed state, and the compressed spring force of the deployment spring 275 then provides a distally directed axial force on the deployer rod 56, thereby advancing the anchor deployer 52 in a distal and radially outward direction from the distal section 34 of the elongated housing 22, as discussed above with respect to other embodiments contained herein.

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

[0095] With respect to quantifying the outward angular deflection of the anchor deployer 52, the firing axis 276 is the 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, the distal section 45 of each of the anchor deployer lumens 42 may be configured to provide an outward angular deflection of the anchor deployer 52 having a firing axis 276 that forms an angle 278 of about 15 degrees to about 35 degrees relative to the longitudinal axis 272 of the nominal anchor deployer lumen section 274 disposed proximally of the distal section 45 of the anchor deployer lumen 42 and / or the longitudinal axis 244 of the elongated housing 22. For some embodiments, the curve profile 270 of the distal section 45 of each of the anchor deployer lumens 42 may be configured to produce such a range of firing axes 276 and associated angles 278, as discussed above. For some embodiments, the distal section 45 of each anchor deployer lumen 42 may be configured to provide outward angular deflection of the anchor deployer 52 without the use of a curved profile. For example, an abutment, deflection block, or other suitable structure (not shown) configured to deflect the anchor deployer 52 may be disposed within a distal section 45 of the anchor deployer lumen 42 that has an otherwise straight shape without a curved profile.

[0096] In addition, each distal section 45 of the anchor deployer lumen 42 may have a recessed pocket 282 with an inner surface contour 284 configured to receive the outer surface contour of the individual anchor 62 disposed therein with a close fit therebetween. In such a case, the close fit between the inner surface contour 284 of the recessed pocket 282 and the outer surface contour of the individual anchor 62 may include a snap fit or a close slip 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, which is resiliently bent into a deflected configuration by its curved profile and curvature. This snap fit or close 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] 20, the distal section 34 of the elongated housing 22 is shown disposed above and adjacent to the tissue layer 64, with the longitudinal axis 244 of the elongated housing 22 aligned with the center of the passageway 216 in the tissue layer and the access hole 124 of the blood vessel 128. In some cases, for such an arrangement, the longitudinal axis 192 of the elongated shaft 82 of the inner catheter assembly 78 (the inner catheter assembly 78 is not shown in FIG. 20 for purposes of clarity of illustration) 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 circumstances.

[0098] For such embodiments, the deployment pattern for the anchors 62 of the multiple anchor deployers 52 may be an asymmetric deployment pattern. In some cases, for such asymmetric deployment patterns, the anchor puncture sites may be located in the tissue layer 64 on 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 deployment pattern 243 may be effectively offset laterally or in any other suitable direction such that the puncture sites in the tissue layer 64 for the anchor deployers 52 on one side of the elongated housing 22 are located farther from the longitudinal axis 244 of the elongated housing 22, the longitudinal axis 192 of the elongated shaft 82, and / or the center of the passageway 216 than the puncture sites of the anchor deployers on the other side of the elongated housing 22, as shown in FIGS. FIG. 20A, in particular, diagrammatically illustrates how the axis of symmetry 245 of the rectangular deployment pattern 243 is laterally offset to the right from the longitudinal axis 192, 244 of the elongated shaft 82 and elongated 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 this lateral offset (or offset in any other direction) may depend on a variety of factors, including certain clinical factors and morphology. In some cases, the distance of offset may be equal to or greater than one-half the lateral width measurement of the target vessel, such as the artery 128. The distance of offset may also be up to the distance of separation of the longitudinal axis 406 of the target vessel 128 and the longitudinal axis of an adjacent vessel, such as the vein 130, as shown in FIG. 20. For some embodiments, the distance of 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 asymmetric deployment patterns may include any other desired deployment pattern 243 other than puncture sites at the corners of a square or rectangular pattern that results in a desired clinical outcome.

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

[0100] For some embodiments, as discussed above, to produce an asymmetric deployment pattern 243, the curved profile 270 of the distal segment 45 of a first anchor deployer lumen 42 of the actuator assembly 12 may include a firing axis 276 that forms a first angle 278 relative to a longitudinal axis 272 of a nominal anchor deployer lumen segment 274 that is disposed proximal to the distal segment 45 of the anchor deployer lumen 42. In addition, the curved profile 270' of the distal segment 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' relative to a longitudinal axis 272' of a nominal anchor deployer lumen segment 274' (not shown) that is disposed proximal to the distal segment 45' of the second anchor deployer lumen 42', the second angle 278' being different from the first angle 278, as shown in the asymmetric deployment pattern of FIG. Such an arrangement, in which the axial positions of the individual distal ports 44, 44' relative to the elongated 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 lumens 42 and the individual distal ports 44 may be selected in other ways to produce the same or any other desired deployment pattern, symmetric or asymmetric. For example, to achieve the same or similar asymmetric deployment pattern shown in FIGS. 20 and 20A, the angle 278 of the firing axis 276 of each of the expander lumens 42 may be the same. However, the axial location of the distal ports 44 on one side (the side of the vein 130) may be located further proximally from the distal end 28 of the elongated housing 22 than the distal ports 44 on the side opposite the vein 130. That is, the axial location and firing axis 276 of each of the anchor deployer lumens may be configured in any suitable manner to produce the desired deployment pattern and desired offset from the longitudinal axis 244 of the elongated housing 22 and / or the longitudinal axis 192 of the elongated shaft 82.

[0102] 29 and 30, any number of configurations of anchor embodiments 62 and deployment rod embodiments 56 may be used for multiple anchor deployers 52 that provide useful and reliable anchoring capabilities. In some cases, anchor 62 embodiments may include a sharp distal tip 286, such as a trocar tip, configured to distally penetrate tissue 64, as shown in FIG. 29. Such anchor embodiments 62 may also include a tab 288, which may be raised or otherwise biased radially outward, at a proximal end 290 of the anchor 62. The tab 288 may be configured to create a feature that may serve to aid in 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 engaging the tissue 64 and resisting retrograde translation of the anchor 62 once deployed into the tissue. Such anchor embodiments 62, including their proximal tubular portions, may be releasably disposed on the distal end 58 of an individual deployment rod 56. For such embodiments, 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, such that the distal tip 58 does not directly interact with the tissue 64 upon distal extension and actuation. Each anchor embodiment 62 may further be secured to the distal end 68 of a filament 66 that is used to apply a radially inward tension force to each of the anchors 62 once they are deployed into the target tissue of the tissue layer 64. The anchors 62 having a sharp distal tip 286 may be made from any suitable rigid high strength material configured for tissue penetration and anchoring. In some cases, such anchor embodiments 62 may be made from a metal, such as stainless steel, nickel titanium alloy, or the like, which may be non-bioabsorbable in some cases. In some cases, such anchors may also include a bioabsorbable material.

[0103] In other embodiments, each anchor deployer 52 of the multiple 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, an individual anchor 62' may be removably secured to the distal end 58' of the deployment rod 56', have a tubular configuration, and be devoid of 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, having an outer surface contour 298 configured to mate with an inner surface contour of the inner lumen 302 of the tubular configuration of the anchor embodiment 62'. In addition, the deployment rod embodiment 56' may further include a shoulder 304 facing distally and having a stop surface 306 disposed at a proximal end 308 of the anchor receiving surface 296. In such cases, the stop surface 306 may extend radially outward from the anchor receiving surface 296 and function to fix the axial position of the anchor 62' on the anchor receiving surface 296 during tissue penetration.

[0104] Such anchor embodiments 62' may further include a filament attachment feature or loop 312 disposed on an outer surface 314 of the anchor 62', or any other suitable location, having a filament hole 316 or other suitable feature configured to be secured to a 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 section 68 of the filament 66. Such filament attachment features 312 may also be used on any of the other anchor embodiments 62 discussed herein, including those anchor embodiments having a sharp distal tip 286.

[0105] Anchor embodiments 62' without a sharp distal tip 286 may be made from any suitable rigid high strength material configured for anchoring. In some cases, such anchor embodiments 62' may be made from a metal, such as stainless steel, nickel titanium alloy, or the like, which in some cases may be non-bioabsorbable. In some cases, such anchor embodiments 62' may also include a bioabsorbable material.

[0106] Some anchor deployer embodiments 52 may include anchors 62″, each of which may be secured to an elongated and flexible filament 66 and configured to be ejected distally from a distal end 322 of an inner lumen 326 of a hollow deployment needle 324. For such embodiments, the hollow deployment needle 324 may have a sharp distal tip 328 and be configured to penetrate tissue 64 upon deployment such that the anchor 62″ disposed therein does not require any tissue-piercing characteristics. Thus, the anchor embodiment 62″ may have a variety of configurations due to serving a single purpose, i.e., anchoring only, once deployed into the target tissue 64, without the need to be sharp for tissue penetration or the inclusion of features such as tabs 288 to resist proximal withdrawal within the tissue 64 and facilitate removal from the deployment rod 56, as discussed above. The hollow deployment needle 324 replaces the deployment rod 56 and has its proximal end secured to a carrier such as the anchor deployer carrier 258, and may function in the same or 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, which is disposed within the inner lumen 326 of the hollow deployment needle 324 proximal to the anchor 62''. 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 distally and deployed to deploy the anchor 62'' from the distal end 322 by any suitable means, including an actuator (not shown) similar or identical to the anchor deployer actuator embodiment 256 shown and discussed herein. For such embodiments, a proximal end or section 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 resilient high strength material, such as a slotted hypotube made from stainless steel, nitinol, or the like, that includes a transverse slot 325 disposed through the wall of the deployment needle 324. The anchor embodiments 62'' may include rigid or compliant biocompatible materials, such as stainless steel, nitinol, PTFE pledgets, bioabsorbable polymers, and non-bioabsorbable polymers. In some instances, 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 closure assembly 10 may also include a filament tensioning mechanism 336 configured to controllably apply axial tension to the filaments 66 of the individual anchor deployers 52 to draw the filaments 66 back into the elongated housing 22 and pull the anchors 62 deployed in the tissue layer 64 closer together. In some cases, the filament tensioning mechanism 336 may include a filament terminal 338 secured to a proximal end of the filament 66 of the multiple anchor deployers 52 and a tension spring 342 operably secured to the filament terminal 338. The filament terminal 338 may be translatable from a first position, in which there is no tension applied to the filament 66 by the filament terminal 338, to a second position, in which tension is applied to the filament 66 through the filament terminal 338 by the tension spring 342.

[0109] For some embodiments, the filament tensioning mechanism 336 is disposed on the chassis portion 14 and may further include a threaded rod 344 that is configured to be rotatable about its longitudinal axis 346 but 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 operably coupled to the threaded rod 344. For such embodiments, the tension control block 348 may be rotatably fixed but axially translatable relative to the chassis portion 14 such that rotation of the threaded rod 344 relative to the chassis portion 14 and the tension control block 348 axially translates the tension control block 348 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 counteracts the tension of the tension spring 342 to controllably apply the tension of the tension spring 342 to the filament 66 through the filament end 338. The filament tensioning mechanism 336 may also have a knob 356 secured to an outer end 358 of the threaded rod 344 to provide a comfortable grip for a user to apply a rotational force to the threaded rod 344.

[0110] With this configuration, at the start of the procedure, prior to activation of knob 356, tension control block 348 is positioned in an upper axial position along threaded rod 344, and the entire tension of tension spring 342 is transferred to and countered by tension control block 348 through tension transfer clip 354, with no tension applied to filament 66. As knob 356 is rotated and tension control block 348 translates downward, the counter force to the tension generated by tension spring 342 is reduced against tension control block 348 as any slack in filament 66 is removed and that tension begins to be applied to filament 66. As knob 356 is further rotated and tension control block 348 translates further downward, more and more tension is transferred from tension control block 348 onto filament 66 through filament end 338. Eventually, all of the tension from the tension spring 342 is transferred to the filament 66 and the tension transfer clip 354 is completely decoupled from the tension control block 348, as shown in FIGURE 57 and discussed below. Such a configuration is very useful for controllably applying a consistent and repeatable tension to the filament 66, especially when the tension spring 342 is a constant force type spring that does not vary significantly in tension as a function of small displacements of the ends of the tension spring 342, as in the embodiment shown.

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

[0112] The filament locking mechanism 72 may also include a filament lock 76 (or multiple filament locks 76) having an inner lumen 370 centered about the distal end 364 of the filament tube 37 at an axial location distal to the distal shoulder surface 366 of the close-fitting bore 362. An embodiment of the filament lock 76 may be configured to self-contract from an expanded state to a relaxed state and configured to crimp onto the filament 66 disposed within the filament lumen 36 of the filament tube 37 once the outward radial support that produces the expanded state of the filament tube 37 is removed. In some embodiments, a filament guide 372 may also be disposed on the distal end 364 of the filament tube 37 to provide a smooth radiused transition for the tensioned filament 66 to be delivered into the distal port 38 of the filament lumen 36 of the filament tube 37 and to prevent fraying or other damage to the filament 66 in this location where they undergo right angle bends, in some cases at small radii. A filament lock bushing 373 may also be disposed on the filament tube 37 distal to the proximal and distal shoulder surfaces 366 of the filament lock 76. The filament lock bushing 373 may have an inner lumen similar to that of the close-fitting bore 362 that is adjacent but slidably disposed to mate with the outer surface of the filament tube 37.

[0113] The filament locking mechanism 72 may further include a filament tube actuator 374 that is operatively coupled to the proximal section 368 of the filament tube 37 and configured to, upon activation, axially retract the filament tube 37 proximally against the distal shoulder surface 366 to push the filament lock 76 away from the distal end 364 of the filament tube 37 and allow the filament lock 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 multiple filament locks 76 axially disposed adjacent to one another on the distal end 364 of the filament tube 37 at axial locations distal to the distal shoulder surface 366 of the close-fitting 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 lock 76 may include a "trailing edge lock" type configuration, as shown in FIGS. 21-24, in which the tubular structure includes a main body portion 378 and a plurality of fingers 382 extending proximally from the main body portion 378. In some cases, the fingers 382 may be of sufficient axial length and resiliently biased toward a central longitudinal axis 384 of the main body portion 378 such that individual distal ends 386 of the fingers 382 are configured to self-contract in an inward radially oriented direction. The fingers 382 may so self-contract from an expanded state to a relaxed state such that when the fingers 382 are in a relaxed state, they crimp onto a filament 66 disposed within the inner lumen 370 of the filament lock 76. In the contracted state, the inner surface of the distal ends 386 of the fingers 382 may form a residual lumen 383 in the absence of any filament disposed therein. Additionally, these finger embodiments 382 may be resiliently spread radially outward with a relative lateral separation to generate an expanded state that may be sufficient to fit over the outer surface of the distal end 364 of the filament tube embodiment 37. For the filament lock embodiment 76 shown, the fingers 382 have a generally triangular shape with a base portion disposed adjacent a proximal end of the main body portion 378 opposite the distal end 386 and wider than its respective distal end 386.

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

[0116] Some embodiments of the filament lock 76' may include a coiled spring filament 376, with an inner lumen 370 of the filament lock 76' sized to crimp onto the 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 profile. For example, in some cases, the transverse cross-sectional profile of the coiled spring filament may have a rectangular or diamond-shaped profile such that sharp edges of such a profile may be used to bite into the outer surface of the filament 66 and provide an effective lock therebetween. In some instances, such an arrangement may provide a more secure lock between the filaments than may be provided by a coiled spring filament 376 having a rounded or substantially rounded transverse cross-sectional profile. For such embodiments, the inner lumen 370 may be resiliently expanded in a lateral dimension sufficient to fit over the outer surface of the distal end 364 of the filament tube 37, as shown in FIG.

[0117] Once the retracted filaments 66 of the vascular closure assembly 10 are locked in place relative to one another, it may be useful to cut the filaments 66 at a location proximal to the filament locks 76. Accordingly, some embodiments of the actuator assembly 12 may further include a filament cutter 390 disposed in operative alignment with the filaments 66 of the 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 slider 394 that is angled toward the suture 66 and configured to translate laterally within a bore 396 relative to the suture 66. For such embodiments, the blade 392 may approach the suture 66 during the lateral translation of the blade 392 such that a 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 closure assembly 10 may be used to reduce the size of or eliminate the passageway 216 in the tissue layer 64 disposed above and adjacent the access hole 124 in the blood vessel 128 to provide hemostasis for the access hole 124 in the blood vessel 128 following a minimally invasive vascular procedure or the like. Such devices and procedures 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 particularly useful in situations where the wall portion 126 of the blood vessel 128 is diseased or otherwise compromised, such as by the presence of calcified plaque as well as many other conditions.

[0119] Some embodiments of a method for vascular closure may include advancing the vascular closure assembly 10 distally over the exposed proximal portion 402 of the guidewire 117, the distal section 404 of which is disposed through the access hole 124 in the patient's blood vessel 128 and through a passage 216 in the tissue layer 64 disposed above and adjacent to the access hole 124, as shown in FIG. 49 . The guidewire 117 is also disposed through the patient's skin layer 125 and tissue disposed between the patient's skin 125 and the tissue layer 64. The method may further include advancing the vascular closure assembly 10 distally over the guidewire 117 while the inner catheter assembly 78 of the vascular closure assembly 10 is disposed within the inner lumen 32 of the elongated housing 22 of the actuator assembly 12 of the vascular closure assembly 10.

[0120] In some cases, the vascular closure assembly 10 may be so advanced with the self-inflating balloon 94 of the inner catheter assembly 78 extending distally beyond the distal end 28 of the elongated housing 22, and with the inner catheter assembly 78 releasably secured to the actuator assembly 12 by the inner catheter assembly position stop 212, preventing relative axial displacement therebetween. Additionally, advancing the vascular closure assembly 10 over the guidewire 117 may, in some cases, include advancing the guidewire lumen 114 of the elongated shaft 82 of the inner catheter assembly 78 of the vascular closure assembly 10 distally over the guidewire 117.

[0121] For some embodiments, the vascular closure assembly 10 may continue to be advanced until blood is observed emerging from the proximal port 122 of the blood return lumen 118 of the inner catheter assembly 78, as shown in FIG. 50. The emergence 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 extension 166. Typically, the distal section 34 of the elongated housing 22 is disposed at or below the patient's outer skin layer 125 at this stage as well.

[0122] The method thus includes deploying the foot extension 166 from the elongation shaft 82 of the inner catheter assembly 78. In some instances, the foot extension 166 is deployed from a position within the interior volume 98 of the self-inflating balloon 94, as shown in FIGS. 39 and 50. The foot extension 166, in this case, is disposed along the elongation shaft 82 within the interior volume 98 of the self-inflating balloon 94 such that as the foot extension 166 extends radially outward from the elongation shaft 82, it may also push a portion of the wall 96 of the self-inflating balloon 94 radially outward; however, the wall 96 of the self-inflating balloon 94 may be configured to be thin and flexible enough to conform to the outer contour of the foot extension 166 without interfering with the function of the foot extension 166. As discussed above, in some cases, the leg extensions 166 may be axially disposed such that they are coextensive with the self-inflating balloon 94, but are not within the interior volume 98. For such embodiments, the leg extensions 166 may be deployed from a location outside of the interior volume 98.

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

[0124] Once the self-inflating balloon 94 and the foot extension 166 disposed therein are axially secured 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 Figures 36 and 37, to allow pressurized blood to flow from within the interior volume 150 of the patient's blood vessel 128, through the balloon inflation lumen 102 of the inner catheter assembly 78, and into the interior volume 98 of the self-inflating balloon 94. The self-inflating balloon 94 may continue to be allowed to inflate until contact and hemostasis are established between the outer surface 154 of the self-inflating balloon 94 and the surrounding surface 156 of the access hole 124 in the blood vessel 128, as shown in Figure 51.

[0125] The inner catheter assembly 78 may then be released from the actuator assembly 12 by releasing the inner catheter assembly position lock 212 and allowing the inner catheter assembly 78 to translate axially relative 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 a fixed axial position relative to the access hole 124 in the blood vessel 128 until the distal end 28 of the elongated housing 22 of the actuator assembly 12 is disposed adjacent the passageway 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 an insertion alignment mark 224 disposed on the inner catheter assembly 78.

[0126] The technique may be useful for a variety of patients having different tissue morphologies in the area of ​​the passageway 216 and access hole 124 in the tissue layer 64. Generally, the distance between the tissue layer 64 (e.g., the fascial layer, etc.) and the vessel wall 126 (e.g., the vessel wall 126 of the femoral artery, etc.) will be reasonably consistent from patient to patient, even though the distance between the outer surface of the patient's skin and the fascial layer 64 may vary significantly from patient to patient.

[0127] In some cases, once in 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, and as shown in FIG. 52, it may be useful at this point to orient the longitudinal axis 244 of the elongated housing 22 relative to the longitudinal axis 406 of the patient's blood vessel 128, as indicated by arrow 407. Orienting the longitudinal axis 244 of the elongated housing 22 relative to the longitudinal axis 406 of the patient's blood vessel 128 may include forming an angle between about 50 degrees to about 80 degrees between the longitudinal axis 244 of the elongated housing 22 and the longitudinal axis 406 of the blood vessel 128. Orienting the longitudinal axis 244 of the elongated 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 elongated housing 22 and the longitudinal axis 406 of the blood vessel 128 until the ball bearing 248, located within the conical cavity 236 of the angle alignment mechanism 232, is aligned with the axis of symmetry 238 of the conical cavity 236. It may also be useful at this stage 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 multiple anchor deployers 52 may now be deployed in a distal and radially outward direction away from the distal segment 34 of the elongate housing 22 of the vascular closure assembly 10 by activating an actuation lever 264 of the anchor deployer actuator 256. For some embodiments, activating the actuation lever 264 may include depressing the actuator lever 264, which is coupled to the anchor deployer carrier 258, which is operably coupled to the proximal segment 262 of each of the multiple deployer rods 56, as shown in FIGS. 53 and 54. For some embodiments, depressing the actuator lever 264 results in a rotation of the actuator lever 264, which in turn causes the anchor deployer carrier 258 and the proximal segment 262 of the multiple deployer rods 56 to axially translate in the distal direction. The anchor deployers 52 may be deployed such that the anchors 62 extend distally beyond the distal end 28 of the elongate housing 22 and penetrate or otherwise engage to assist axial tension on the filaments 66 at a location where the tissue layer 64 is centered about a passageway 216 in the tissue layer 64 with the individual anchors 62 of the multiple anchor deployers 52, as shown in FIG. 54. In some cases, deploying the multiple anchor deployers 52 in a distal and radially outward direction away from the distal section 34 of the elongate housing 22 may include deploying the multiple 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 anchors 62 are secured to the tissue layer 64 at these locations that are centered about the passageways 216 in the tissue layer 64. In some cases, securing the anchors 62 to the tissue layer 64 at locations that are centered about the passageways 216 in the tissue layer 64 may include penetrating the tissue layer 64 with each of the anchors 62 of an individual anchor deployer 52 and detaching each anchor 62 from its individual deployment rod 56 at a location beneath the tissue layer 64. Although anchor embodiment 62 is shown as deployed, anchor embodiment 62' or 62'' or any other suitable anchor embodiment and associated anchor deployer embodiment 52 may be used for the present method. At this stage, the actuator assembly 12 may also optionally be rotationally and angularly oriented after deploying the anchor deployer 52 and prior to proximally retracting the deployment rod 56 of the anchor deployer 52 until the longitudinal axis 244 of the elongated housing 22 is approximately perpendicular to the longitudinal axis 406 of the vessel 128. Such a perpendicular or near-perpendicular orientation may be useful in some circumstances to facilitate desired engagement of the anchor deployer 52 with the tissue layer 64.

[0130] The deployment rods 56 of the anchor deployers 52 may then be retracted proximally into the elongated housing 22 by releasing the spring-loaded anchor deployer actuators 256, as shown in FIG. 55, or by any other suitable means. The anchors 62 may now be pulled closer 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 closer together to one another as the filaments 66 are tensioned and translated generally radially inward, as shown in FIG. 56, thereby reducing the lateral dimension of the passage 216 in the tissue layer 64.

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

[0132] The balloon inflation valve 112 of the inner catheter assembly 78 may then be closed at this stage by deactivating the balloon inflation lever 148, thus closing the balloon inflation lumen 102, which prevents fluid communication between the interior volume 150 of the blood vessel 128 and the interior volume 98 of the self-inflating balloon 94. Thus, the inflation pressure from within the interior volume 150 of the blood vessel 128 is excluded from the interior volume 98 of the self-inflating balloon 94, as shown in FIG. 37, and the interior volume 98 may also be vented to the surrounding atmosphere through the inflation port 104 and back towards the proximal chassis 92, thereby allowing the self-inflating balloon 94 to deflate. The inner catheter assembly position lock 212 may then be released and the extension shaft 82 and self-inflating balloon 94 of the inner catheter assembly 78 may be advanced slightly distally to alleviate mechanical interaction between the interior surface 152 of the blood vessel 128 and the deployed foot extension 166. The foot extensions 166 may then be retracted back to the retracted position by deactivating the foot extension actuators 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 elongated 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 elongated shaft 82 of the inner catheter assembly 78. Such axial alignment of the inner catheter assembly 78 and actuator assembly 12 indicates that the deflated self-inflating balloon 94 and the distal end 86 of the elongated shaft 82 have been retracted proximally into the inner lumen 32 of the elongated housing 22 and no longer interact with the access hole 124 or the passageway 216 in the tissue layer 64. This alignment may also indicate that the elongated shaft 82 of the inner catheter assembly 78 has been completely withdrawn with only the guidewire 117 remaining in the passageway 216, as shown in FIG.

[0134] As the inner catheter assembly 78 is removed, the deflated self-inflating balloon 94 is simultaneously withdrawn from the access hole 124 and the passageway 216 in the tissue layer 64, allowing tension on the filament 66, which is affixed to the tissue layer 64, and may completely close the passageway 216 in the tissue layer 64. During this process, it is noted that once the tension of the tension spring 342 is applied to the tethered filament 66, the tissue layer 64, which is disposed about the self-inflating balloon 94, is tightened around the outer surface 154 of the self-inflating balloon 94 to provide hemostasis during whether the self-inflating balloon 94 is in an inflated or deflated state. However, the pressure of the tissue layer 64, which is disposed about the passage 216 that is disposed about the self-inflating balloon 94, is not great enough to prevent the outer surface 154 of the self-inflating balloon 94 and the distal elongate shaft 82 of the self-inflating balloon 94 from sliding axially through the passage 216 in the tissue layer 64 during proximal removal of the inner catheter assembly 78.

[0135] One or more filament locks 76 may then be deployed onto the filament 66 at the distal end 28 of the elongated housing 22 by activating the filament locking mechanism 72 while maintaining tension on the filament 66 with the tension spring 342. In some cases, activating the filament locking mechanism 72 may include depressing a filament tube actuator 374 coupled to a filament tube 37 positioned about the filament 66 within the elongated 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 lock 76 in the expanded state is pushed from the distal end 364 of the filament tube 37 onto the filament 66, as shown in FIG.

[0136] For such embodiments, the filament lock 76 may include a self-retracting configuration, and the deployment method embodiment may further include allowing the self-retracting filament lock 76 to contract to a relaxed state over the filament 66, thereby crimping at least one filament lock 76 onto the outer surface of the filament 66 and against each other once the outward radial support of the filament tube 37 is removed from within the filament lock 76. The outward radial support of the filament tube 37 against the inner surface of the filament lock 76 may be removed by retracting the distal end 364 of the filament tube 37 proximally past a distal shoulder 366 of the close-fitting bore 362 and an optional filament lock bushing 373 disposed about the distal end 364 of the filament tube 37. In some cases, multiple filament locks 76 may be deployed by pushing the multiple filament locks 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 locks 76 may be deployed on the filaments 66 to secure the filaments 66 in a fixed relationship to one another and lock them in tension.

[0137] With respect to the filament lock embodiment 76 shown, crimping at least one filament lock 76 onto the filament 66 may include radially deflecting a plurality of proximally extending fingers 382 of the trailing edge locking filament lock embodiment 76 inwardly to crimp a proximal end 386 of the proximally extending fingers 382 onto the filament 66. In some cases, deployment may include wedging a proximally extending finger 382 of a distal-most trailing edge locking filament lock embodiment 76 into the inner lumen 370 of a proximally adjacent filament lock 76 during deployment.

[0138] The filament 66 may then be optionally severed at a location proximal to the filament lock 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 disposed in operative alignment with the filament 66. In some cases, the sharp blade 392 of the tissue cutter 390 may be disposed within a slider 394, and actuating the filament cutter 390 of the actuator assembly 12 may include translating the slider 394 and sharp blade 392 relative to the filament 66 within a bore 396, thereby approaching the filament 66 during lateral translation and contacting a sharp edge 398 of the blade 392 with the filament 66, thereby cutting through the filament 66. Once the filament 66 has been severed, the vascular closure assembly 10 may be withdrawn from the patient, as shown in FIG. 61, and treatment of the puncture site may be completed.

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

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

Claims

[Claim 1] The invention described in this specification.

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