US20190142403A1 - Tissue closure device - Google Patents

Abstract

Collapsible tube embodiments may be used to promote hemostasis at surgical sites or any other suitable location. In some cases, vascular closure device embodiments may include collapsible tube embodiments in order to promote hemostasis at a surgical site during a vascular closure procedure.

Description

RELATED APPLICATIONS
• This application claims priority from U.S. Provisional Patent Application Ser. No. 62/587,353, filed on Nov. 16, 2017, by Henrik Nyman et al. titled “Device for Mechanical Approximation of Fascia”, which is incorporated by reference herein in its entirety.
BACKGROUND
• In many percutaneous cardiovascular procedures, a catheter is inserted into an artery, such as the femoral artery, through a percutaneous vascular access. The catheter may be inserted, typically over a guidewire, directly into an artery (a “bareback” procedure), or the catheter may be inserted through a vascular introducer. When the procedure is complete, the physician removes the catheter and then removes the introducer from the vessel (if one was used). The physician then must prevent or limit the amount of blood that leaks through the vascular access. Physicians currently use a number of methods to close the vascular access, such as localized external compression, suture-mediated closure devices, plugs, gels, foams and similar materials.
• However, such closure procedures may be time consuming, and may consume a significant portion of the time of the procedure. In addition, existing methods are associated with complications such as hematoma or thromboses. Still further, some of such procedures, particularly suture-mediated closure devices, are known to have high failure rates in the presence of common vascular disease such as atherosclerosis and calcification.
SUMMARY
• Some embodiments of a vascular closure device may include a housing having an elongate configuration with an axial length greater than a transverse dimension thereof. Such a housing may further include a proximal end, a distal end and a distal section. A plurality of anchor deployers are slidably disposed within the housing adjacent each other at the distal section of the housing and are configured to extend and spread from the distal section of the housing. Each of the anchor deployers may include a deployment rod which is slidably disposed relative to the housing and which includes an elongate resilient configuration. Each deployment rod may also include a distal end that extends distally and radially from the distal section of the housing so as to spread out from other deployment rod distal ends. In some cases, the deployment rods may be configured to extend distally at the same time or simultaneously. Each anchor deployer may also include an anchor which is secured to the distal end of the deployment rod and which is configured to grip tissue such as the tissue of a fascia tissue layer. The vascular closure device embodiment may further include a tissue grip which is deployable from the distal end of the housing.
• Some embodiments of a method for vascular closure may include disposing a distal end of the housing of the vascular closure device to a position adjacent the passage in the tissue layer and deploying a plurality of anchor deployers from a distal section of the housing. The anchor deployers may be so deployed by distally advancing deployment rods of the anchor deployers in a distal and radially outward direction from the housing into the tissue layer in positions disposed about the passage in the tissue layer. Respective anchors of the anchor deployers may then be secured to the tissue layer in positions disposed about the passage in the tissue layer. The deployment rods may then be proximally retracted back into the distal section of the housing so as to draw the anchors and respective tissue layer portions secured thereto together adjacent the distal section of the housing to gather the tissue and close the passage in the tissue layer. Thereafter, a tissue grip may be deployed over the anchors and onto the tissue layer portions gathered and secured to the anchors so as to secure the tissue layer portions together with the access hole closed or reduced. The anchors may then be released from the tissue layer portions which are secured together.
• Some embodiments of a method for vascular closure may include disposing a distal end of the housing of the vascular closure device to a position adjacent the passage in the tissue layer and deploying a plurality of anchor deployers from a distal section of the housing. The anchor deployers may be so deployed by distally advancing deployment rods of the anchor deployers in a distal and radially outward direction from the housing into the tissue layer in positions disposed about the passage in the tissue layer. Respective anchors of the anchor deployers may then be secured to the tissue layer in positions disposed about the passage in the tissue layer. The deployment rods may then be proximally retracted back into the distal section of the housing so as to draw the anchors and respective tissue layer portions secured thereto together adjacent the distal section of the housing to gather the tissue and close the passage in the tissue layer. Thereafter, a tissue grip may be deployed over the anchors and onto the tissue layer portions gathered and secured to the anchors so as to secure the tissue layer portions together with the access hole closed or reduced. The anchors may then be detached from each of the respective deployment rods secured thereto and left in the patient secured to the tissue layer.
• Some embodiments of a method for vascular closure may include disposing a vascular closure device adjacent a passage in a tissue layer which is disposed above and adjacent an access hole in a blood vessel of a patient and deploying a plurality of anchors from a distal section of the vascular closure device in a distal and radially outward direction therefrom. The method may also include engaging the tissue layer in positions disposed about the passage in the tissue layer with the anchors and securing the anchors to the tissue layer in the positions disposed about the passage in the tissue layer. Thereafter, the anchors may be proximally retracted closer together so as to draw the anchors and respective tissue layer portions secured thereto together thereby closing the passage in the tissue layer. A tissue grip may then be deployed onto the tissue layer portions drawn together by the anchors so as to secure the drawn together tissue layer portions thereby closing the passage in the tissue layer and achieving vascular closure of the access hole in the blood vessel.
• Certain embodiments are described further in the following description, examples, claims and drawings. These features of embodiments will become more apparent from the following detailed description when taken in conjunction with the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 schematically exemplifies a first embodiment of a vascular closure device according to a possible embodiment of the present disclosure.
• FIGS. 2A and 2B show a detailed view of the creation of a tissue lock using the vascular closure device.
• FIGS. 2C and 2D illustrate a closure sequence for treatment of an unwanted passage through a wall of a blood vessel without directly engaging the blood vessel.
• FIGS. 3A and 3B conceptually illustrate an engagement member, exemplified as an anchor element.
• FIGS. 4A and 4B illustrate the operation of an anvil member that functions as a deployable positioning feature.
• FIG. 5 is an elevation view of a vascular closure device embodiment.
• FIG. 6 is an enlarged view of the encircled portion6-6 of the vascular closure device embodiment ofFIG. 5.
• FIG. 6A is a front view of the vascular closure device embodiment ofFIG. 5.
• FIG. 7A is an elevation view of a lock ring embodiment.
• FIG. 7B is a top view of the lock ring embodiment ofFIG. 7A.
• FIG. 7C shows a top view of the lock ring embodiment ofFIG. 7A in a radially expanded state.
• FIG. 7D is a transverse cross section of the lock ring embodiment ofFIG. 7B taken alonglines7D-7D ofFIG. 7B.
• FIG. 8A is an elevation view of a lock ring embodiment.
• FIG. 8B is a top view of the lock ring embodiment ofFIG. 8A.
• FIG. 8C is a top view of the lock ring embodiment ofFIG. 8A in a radially expanded state.
• FIG. 9 is an elevation view of a releasable anchor embodiment in a closed state.
• FIG. 10 is an elevation view of the releasable anchor embodiment ofFIG. 9 in an open state.
• FIG. 10A is a transverse cross section of the deployment rod ofFIG. 10 taken alonglines10A-10A ofFIG. 10.
• FIG. 11 is an elevation view of a releasable anchor embodiment in a straightened state.
• FIG. 12 is an elevation view of the releasable anchor embodiment ofFIG. 11 in a curved, tissue gripping state.
• FIG. 12A is a transverse cross section of a deployment rod embodiment ofFIG. 12 taken alonglines12A-12A ofFIG. 12.
• FIG. 13 is an elevation view of a detachable anchor embodiment.
• FIG. 13A is an enlarged view of the encircledportion13A-13A of the detachable anchor embodiment ofFIG. 13.
• FIG. 13B is a transverse cross section of the deployment rod embodiment ofFIG. 13 taken alonglines13B-13B ofFIG. 13.
• FIG. 14 is an elevation view of a detachable anchor embodiment.
• FIG. 14A is a transverse cross section of the deployment rod embodiment ofFIG. 14 taken alonglines14A-14A ofFIG. 14.
• FIG. 15 is an elevation view in partial section of a distal section of a housing of a vascular closure device disposed adjacent an access hole of a fascia tissue layer.
• FIG. 16 shows the vascular closure device ofFIG. 15 with the anchor deployers distally extended and with anchors thereof secured to the fascia tissue layer.
• FIG. 16A shows the releasable anchor embodiment ofFIG. 9 in a closed state and secured to fascia tissue.
• FIG. 16B shows the releasable anchor embodiment ofFIG. 11 in a curved tissue gripping state secured to fascia tissue.
• FIG. 16C shows the detachable anchor embodiment ofFIG. 14 disposed in and secured to fascia tissue.
• FIG. 16D shows the detachable anchor embodiment ofFIG. 13 disposed in and secured to fascia tissue.
• FIG. 17 shows the anchor deployers of the vascular closure device ofFIG. 16 being proximally retracted and closing the access passage in the fascia tissue layer.
• FIG. 18 is an elevation view in partial section showing the lock ring being deployed from the distal end of the housing of the vascular closure device ofFIG. 5.
• FIG. 19 shows the lock ring ofFIG. 18 disposed around and securing portions of the fascia tissue layer gathered by the anchors of the vascular closure device ofFIG. 5.
• FIG. 20 shows portions of the fascia tissue layer disposed about the access hole in a gathered and secured state with the lock ring and tissue adhesive disposed thereon.
• FIG. 21 shows portions of the fascia tissue layer disposed about the access hole in a gathered and secured state with tissue adhesive only disposed thereon.
• FIG. 22 shows portions of the fascia tissue layer disposed about the access hole in a gathered and secured state with the lock ring disposed thereon, the lock ring being further secured in fixed relation to the portions of fascia tissue by detachable anchors which are secured to the fascia tissue above the lock ring which may be mechanically captured by the deployed detachable tissue anchors.
• FIG. 23 shows a lock ring embodiment in a relaxed self-constrained state disposed about and securing portions of gathered fascia tissue layer.
• FIG. 24 shows upward and inward facing barb embodiments of the lock ring embodiment ofFIG. 23 penetrating into gathered tissue of the portions of fascia tissue layer and mechanically preventing upward movement of the lock ring relative to the fascia tissue.
• The drawings are intended to illustrate certain exemplary embodiments and are not limiting. For clarity and ease of illustration, the drawings may not be made to scale, and in some instances, various aspects may be shown exaggerated or enlarged to facilitate an understanding of particular embodiments.
DETAILED DESCRIPTION
• After a minimally invasive vascular procedure, a hole in the form of an access passage or the like may be left in a major vessel at an access site that must be closed. Methods for percutaneous closure of such a hole may include remote suturing of the vessel, plugging the hole, and remote suturing of the fascia adjacent to the vessel. Certain device and method embodiments discussed herein are directed to mechanical closure of an access passage in the fascia tissue layer adjacent to an access hole in a vessel such as an artery or vein of a patient. Some of these embodiments may also be applicable to direct closure of an arterial wall in some instances. Some vascular closure device and method embodiments discussed herein may provide a robust and easy-to-use device for closing a vascular access hole after a minimally invasive procedure. In some cases, vascular closure device embodiments discussed herein may be useful for closing large vascular access holes. In addition, certain vascular closure device and method embodiments are discussed in U.S. patent application Ser. No. 15/277,542, filed Sep. 27, 2016, by Thomas Larzon, et al., entitled VASCULAR CLOSURE DEVICE, which is incorporated by reference in its entirety.
• The following discussion of the device and method embodiments ofFIGS. 1-4B is directed generally to closure of a vascular access passage as well as axial positioning of certain portions of vascular closure device embodiments during such a closure procedure. Such axial positioning devices and methods may be applied to and used with any appropriate vascular closure device or method of embodiment discussed herein. Turning now to the drawings, and toFIG. 1 in particular, an embodiment of avascular closure device10 is introduced percutaneously over aguide wire8 into a blood vessel/artery5, through theskin1 and thefascia lata2 of a patient. An optional anvil member9 may be arranged inside theblood vessel5 to create a reference point along an axial orientation to theengagement members11 and/or for controlling bleeding from an inner lumen of theartery5. Theengagement members11 may then be placed and released through thevascular closure device10 and may attach tofascia tissue3 proximate to theblood vessel5 and may involve the fascia membrane3 (fascia iliacus), but, in some instances, not awall22 of theblood vessel5. Theengagement members11 may for example be pushed out of thevascular closure device10 and into thefascia membrane3 using deployment members provided aspusher rods12 arranged in independent lumens provided with thevascular closure device10, for example through a pusher assembly in a common lumen that simultaneously deploys allengagement members11, through a spring-loaded mechanism or the like. For some embodiments, theengagement members11 may be connected with a single filament such as a suture or a plurality of filaments or sutures13. InFIG. 1 there is further shown afemoral vein4, afemoral nerve6 and adjacent/interstitial tissues7.
• With further reference toFIGS. 2A and 2B, thesuture13 may for example be routed through each of theengagement members11 in sequence. In particular, onesuture13 may be looped through each of theengagement members11 in sequence, or aseparate suture13 may be attached to eachengagement member11. The tissue,e.g. fascia membrane3, may then pulled together in a radially inward direction towards an access passage in thefascia layer3 with thesuture13 connected to theengagement members11. When pulled together, the tissue/fascia membrane3 is tightened towards the center and the access passage therethrough and may then create a tissue lock, thereby indirectly sealing the access hole in theartery5. That is, a distance between the initial position of theengagement members11 and a distance between the engagement members once theengagement members11 have been moved radially inward towards each other is thereby reduced. When tightening thefascia membrane3 the anvil member9 may be removed from theartery5.
• Referring toFIGS. 2C and 2D, an embodiment of a vascular closure sequence is shown whereby a passage through awall22 of thevessel5 such as the blood vessel shown is treated such that leakage of blood from the interior volume of the blood vessel (not shown) is slowed or stopped to a clinically acceptable degree. As seen inFIG. 2C, a passage in the wall of the blood vessel, specifically, thefemoral artery5, is disposed in general alignment with a passage through thefascia tissue layer3 disposed proximate to an outer surface of thefemoral artery5. For this particular exemplary embodiment, the tissue layer disposed outside of and proximate to the outer surface of thefemoral artery5 is thefascia iliacus3. For purposes of this general discussion, the phrase “in general alignment” as applied to the respective passages may mean at least that an appropriately sized elongate device such as a catheter or sheath may pass through both passages without significant relative lateral displacement between thetissue3 andartery5.
• In addition, in some cases, thetissue layer3 may be disposed sufficiently proximate the outside surface of theblood vessel5 such that gathering and approximation of thefascia tissue3 which is disposed about the passage through thetissue3 so as to close the passage through the tissue/fascia membrane3 and form a tissue lock is sufficient to tighten and displace the closed gathered tissue/fascia membrane3 against the outer surface of theartery5 which is adjacent the passage through theartery5 as shown inFIG. 2D.
• When the gatheredtissue3 has been displaced and deflected so as to be disposed against the passage of theartery5 and wall of theartery5 disposed about the passage in theartery5, this mechanical approximation will typically be sufficient in order to achieve a clinically sufficient slowing or stoppage of blood leakage from the passage in theartery5 in order to permit closure of an access site through the patient'sskin1 adjacent the passages. In some instances, an inner surface of thetissue layer3 disposed proximate to the outer surface of theblood vessel5 may be separated from the outer surface of the blood vessel in the region of the respective passages therethrough by a distance of up to about 10 mm, more specifically, up to about 5 mm.
• With further reference toFIGS. 3A and 3B, there is conceptually illustrated an engagement member, exemplified as ananchor element15. InFIG. 3A, theanchor element15 is shown as initially deployed, so that it slides easily in the direction away from a deployment point. Note that the deployment point may optionally be deflected toward the tissue/fascia membrane3 to promote engagement.FIG. 3B shows theanchor element15 after motion has been reversed toward the deployment point, and theanchor element15 has embedded into the tissue/fascia membrane3. That is, atip17 of theanchors element15 is in one embodiment hook-shaped, so that it easily slides outward without engaging the tissue/fascia membrane3. However, once theanchor element15 is retracted, at least thetip17 of theanchor element15 is adapted to mechanically engage with the tissue/fascia membrane3.
• FIGS. 4A and 4B conceptually illustrate the operation of an anvil member exemplified as adeployable positioning feature20. InFIG. 4A,deployable positioning feature20 may be inserted through thewall22 and into the interior volume of the blood vessel, such as thefemoral artery5. Thedeployable positioning feature20 may be structured similar to an umbrella (using a mesh material), where thedeployable positioning feature20 in a radially collapsed form may be inserted into theartery5. Once within theartery5, with further reference toFIG. 4B, thedeployable positioning feature20 may be “unfolded” and radially expanded from the collapsed form such that a total surface area proximate to the longitudinal axis of thedeployable positioning feature20 is increased and thus may be retracted towards the interior wall of theartery5. Accordingly, a reference point may be thereby established for further operation of thevascular closure device10.
• For the vascularclosure device embodiments24 shown inFIGS. 5-24, a mechanical “grabber” type device may be used to grab thefascia tissue layer3 around anaccess hole25 in the fascia (seeFIG. 15), pull it together, and apply a tissue grip type of device such aslock ring27 or other tissue grip type retention mechanism such as a tissue adhesive30 directly to the tissue of thefascia3 to secure the gatheredfascia tissue32 disposed around theaccess hole25 in the closed position to form a tissue lock and achieve vascular closure of an access hole in theadjacent vessel5.FIGS. 5-24 illustrate embodiments of such grabber-typevascular closure devices24. The arms, also referred to herein asanchor deployers26, may be initially retracted into ahousing28 to achieve a low profile. Once in place above thefascia tissue layer3, thearms26 may be extended distally and radially outward. Due to their preformed curved shape formed from an elastic resilient material (such as stainless steel or nitinol), thearms26 may be configured to spread out into a radially dispersed pattern disposed around theaccess hole25 in thefascia tissue layer3.
• Thearms26 may then engage thefascia tissue layer3 at two or more points around theaccess hole25. This engagement may be accomplished by ananchor31 such as asmall jaw34 or the like mounted on thedistal end36 of adeployment rod38 of eacharm26 and adapted to grab thefascia3, or asmall hook15,40 (seeFIGS. 3A and 12) could be used to engage thefascia3. Other similar mechanisms may also be used. Once eacharm26 of thevascular closure device24 has secured thefascia3, thehousing28 may be advanced down over thearms26, or the arms retracted proximally into thehousing28, thereby pulling the distal ends36 of thearms26 together in a radially inward and proximal direction, approximating the edges of thefascia tissue layer3 disposed about theaccess hole25 therein, and closing or minimizing theaccess hole25.
• In addition, the retention mechanism, such as a tissue grip mechanism that holds the approximated edges of the gatheredfascia tissue32 in this gathered configuration, such as the ring orclip27, may then be deployed onto the gatheredtissue32. Thereafter, thearms26 or anchors31 disposed thereon may be disengaged from thefascia tissue layer3 and thevascular closure device24 withdrawn from the patient. Suitable tissue retention may be accomplished in some cases by use of the elastic resilient coil in the form of alock ring27 that is stretched onto the outside of thehousing28 about an outside circumference of thearms26 or outside of a translation track of thearms26. Thelock ring27, which may include an elastic and resilient self-contractinglock ring27, may be pushed off of thehousing28 by adistal end42 of a larger, concentricouter tube44 that lies more proximal over aninner tube46 of thehousing28. In some cases, theouter tube44 may be actuated to advance distally relative to theinside tube46 and deploy thelock ring27 by advancing a lockring actuator lever47 which may be operatively coupled to theouter tube44. Once pushed off theinside tube46 of thehousing28 and onto the gatheredtissue32, such anelastic coil27 may self-contract to circumferentially compress the gatheredtissue32 and brought together by thearms26 in an inner radial direction and retain the gatheredtissue32 in a bunched or gathered configuration, thereby closing or reducing theaccess hole25.
• Suchelastic coil embodiments27 may be made from high strength resilient materials such as stainless steel, nitinol, or the like. Someelastic coil embodiments27 may also be made from or include bioresorbable and/or biodegradable materials. In some embodiments, the gatheredtissue32 may be held together by a biocompatible, rapidly curing tissue adhesive, such as cyanoacrylate, dispensed from adistal section48 of thehousing28. Such a tissue adhesive30 may be dispensed as the gathered tissue of thefascia tissue layer3 is coming together, to facilitate the apposition of surfaces containing tissue adhesive30, or the tissue adhesive30 may be dispensed onto the gatheredtissue32 once the tissue is bunched together.
• Referring toFIGS. 5 and 6, some embodiments of thevascular closure device24 may include thehousing28 having an elongate configuration with an axial length greater than a transverse dimension thereof. Such ahousing28 may further include aproximal end50, adistal end52 and adistal section48. A plurality ofanchor deployers26 are slidably disposed within thehousing28 adjacent each other at thedistal section48 of thehousing28 and are configured to extend and spread from thedistal section48 of thehousing28. Each of theanchor deployers26 may include thedeployment rod38 which is slidably disposed relative to thehousing28 and which includes an elongate resilient configuration. Eachdeployment rod38 may also include thedistal end36 that extends distally and radially outward from thedistal section48 of thehousing28 so as to spread out from other the distal ends36 of thedeployment rods38. In some cases, thedeployment rods38 may be configured to extend distally at the same time or simultaneously. Eachanchor deployer26 may also include theanchor31 which is secured to thedistal end36 of thedeployment rod38 and which is configured to grip tissue such as the tissue of afascia tissue layer3. The vascularclosure device embodiment24 may further include thelock ring27 which may be deployable from thedistal end52 of thehousing28. The vascular closure device ofFIG. 5 includes 4anchor deployers26, however any suitable number ofanchor deployers26 may be used. Some such vascularclosure device embodiments24 may include about 2anchor deployers26 to about 8anchor deployers26, more specifically, about 3anchor deployers26 to about 5anchor deployers26. For some embodiments, it may be desirable for thedeployment rods38 to have a rectangular transverse cross section profile to facilitate distal and radially outward extension while maintaining lateral stability. In some instances, thedeployment rod embodiments38 may a generally flattened cross section profile with a radial transverse dimension that is less than a circumferentially oriented transverse dimension.
• In some cases, thehousing28 may further include aguidewire lumen54 extending an axial length thereof and ahandle56 secured to theproximal end50 of thehousing28. Adeployment rod pusher58 which may optionally be spring loaded with a resilient member such as aspring60 in either a distally biased or proximally biased direction may be operatively coupled to thedeployment rods38 for actuation thereof. For deploymentrod pusher embodiment58 which are proximally biased this may correspond to a bias with thedeployment rods38 biased towards a retracted position which may be overcome by manual pressure in a distal direction against thedeployment rod pusher58. The spring, such asspring60 shown inFIG. 1, may be used to provide such a resilient biasing force on thedeployment rod pusher58. As shown, thedeployment rod pusher58 is operatively coupled to respective proximal ends of thedeployment rods38 and optionally configured to extend thedeployment rods38 simultaneously in a distal direction upon actuation.
• In some instances, embodiments of a tissue grip mechanism may be disposed on thedistal end52 of thehousing28 around theanchor deployers26 but generally not in contact with theanchor deployers26 when in an undeployed state. The tissue grip mechanism may be configured to compress and secure gatheredtissue portions32 relative to each other in some cases. For such embodiments, once the tissue grip is deployed from thedistal end52 of thehousing28 over theanchor deployers26 andrespective anchors31 thereof and onto the tissue which has been gathered and bunched by the proximally retractedanchor deployers26, different portions of the gathered tissue are secured in a fixed position relative to each other to form a tissue lock and, in some instances, vascular closure. In some cases, the tissue grip mechanism may include thelock ring27 disposed about the anchor deployers26 in the form of a self-retractingcoil27 with acentral lumen62 which may be sized to allow movement of the gatheredtissue portions32 disposed therein while the self-retractingcoil27 is in an expanded state as shown inFIG. 7C. Theinterior surface64 of thecentral lumen62 may be configured to compress and secure the gatheredtissue portions32 relative to each other when in a retracted compressed state as shown inFIGS. 7A, 7B, 20, and 22. In some cases, embodiments of the tissue grip may include the tissue adhesive30 that may be dispensed from an outlet port, such as adistal port66 of theguidewire lumen54, in thedistal end52 of thehousing28 as shown inFIGS. 20 and 21. For some embodiments, such as the tissue adhesive30 may include cyanoacrylate, fibrin glue, PEG-based polymers or the like.
• In general, the tissue grip embodiments such aslock ring27 and tissue adhesive30 may optionally include a tissue engagement feature that is configured to stick to a surface of the gatheredtissue32 such as with the tissue adhesive30 forming a bond with the gatheredtissue32 or sharpinner edge64 of the diamond profiledlock ring27 mechanically impinging the gatheredtissue32 so as to effectively secure the tissue portions together. Such tissue engagement features may further include features which may be mechanically captured within the gatheredtissue32 such as thebarbs76 of the “castle shaped”lock ring27′ shown inFIG. 8A. Thebarbs76 are configured to penetrate the gatheredtissue32 and be mechanically captured thereby as shown inFIG. 24. All of these tissue engagement feature embodiments may generally be used to keep the tissue grip embodiments from slipping off of the gatheredtissue32 once deployed.
• For some embodiments ofvascular closure devices24 discussed herein, theanchors31 may include releasable anchors. For example, some releasable anchor embodiments may include thejaw34 that can be moved between an open state and a closed state, eachjaw34 further including an opposed pair oftissue gripping teeth68 as shown in theanchor embodiment31 ofFIGS. 9-10A and 16A.Such anchors31 that include ajaw34, may be actuated by apull wire69 or the like that may apply tension to a hingedlever71 at a proximal end of a hingedjaw portion73 of thejaw34 as shown inFIG. 10. In some instances, thepull wire69 or any other suitable actuation mechanism may be actuated by anactuation lever59 which may optionally be disposed on thedeployment rod pusher58 shown inFIG. 5.
• For some releasable anchorembodiments31, each of the releasable anchors may have ashaft70 with an elongate configuration having an axial length greater than an outer transverse dimension of theshaft70. Thereleasable anchor31 may be configured to be actuated between a curved tissue gripping state having the curveddistal end40 as shown inFIG. 12 and a straightened state as shown inFIG. 11. In some cases, theshaft70 of thereleasable anchor31 may further include a sharpeneddistal end72 which is configured to penetrate tissue such as thefascia tissue layer3 when pushed distally, sharpeneddistal end72 first, into thefascia tissue layer3. For some embodiments, theshaft70 may be made from or include an optional shape memory metal that can be actuated between the curved tissue gripping state shown inFIG. 16B and the straightened state shown inFIG. 11. For such embodiments, the shape memory metal of theshaft70 may include nickel titanium alloy. For other such embodiments, theshaft70 may include an optional a bi-metal structure that can be actuated between the curved tissue gripping state and the straightened state.
• In some cases, it may be desirable to use detachable anchors at the distal ends36 of thedeployment rods38 andanchor deployers26. Referring toFIGS. 13-14A,detachable anchor embodiments31 are shown wherein theanchor deployers26 includereleasable junctions74 disposed between each suchdetachable anchor31 andrespective deployment rod38 which is secured thereto. In some cases, thedetachable anchor embodiments31 may include a proximally orientedbarb76, and in some cases, a plurality of proximally orientedbarbs76. For some embodiments, thereleasable junctions74 used to detach suchdetachable anchors31 may include areleasable junction74 released by thermal detachment, mechanical detachment or any other suitable detachment mechanism. Thereleasable junction embodiment74 shown inFIG. 13A includes atether78 which secured between thedistal end36 of thedeployment rod38 andanchor31 and which may be melted by aheater element80 disposed about thetether78. Theheater element80 may be actuated by applying electrical power from apower source82 to theheater element80 through a first electrically conductingwire84 and a second electrically conductingwire86 in electrical communication between thepower source82 and theheater element80.
• Some embodiments of the vascular closure devices discussed herein may include a lateral surface configured to extend radially from a distal extension of thehousing28 while the lateral surface is disposed within ablood vessel5 such as the anvil9 shown inFIG. 1 and thedeployable positioning feature20 shown inFIGS. 4A and 4B and discussed above. Such alateral surface9,20 that extends radially may be used to provide a reference point between relative axial positions of thewall22 of theblood vessel5 and theanchors31 prior to deployment of theanchors31. In some cases, embodiments of theanchors31 may be deployed a predetermined axial distance from thewall22 of theblood vessel5 as measured from thelateral surface9,20 which is disposed against thewall22 of theblood vessel5.
• Referring generally toFIGS. 15-24, some embodiments of a method for vascular closure may include disposing thedistal end52 of thehousing28 of thevascular closure device24 to a position adjacent thepassage25 in thetissue layer3 and deploying a plurality ofanchor deployers26 from adistal section48 of thehousing28. The anchor deployers26 may be so deployed by distally advancingdeployment rods38 of the anchor deployers26 in a distal and radially outward direction from thehousing28 into thetissue layer3 in positions disposed about thepassage25 in thetissue layer3. Respective anchors311 of theanchor deployers26 may then be secured to thetissue layer3 in positions disposed about thepassage25 in thetissue layer3 as shown inFIGS. 16A-16B. Thedeployment rods38 may then be proximally retracted back into thedistal section48 of thehousing28 so as to draw theanchors31 and respective tissue layer portions secured thereto together adjacent thedistal section48 of thehousing28 to gather thetissue3 and close thepassage25 in thetissue layer3. The deployment rods may be withdrawn with a spring or similar mechanism to apply a desired tension, or alternatively may be withdrawn with a lead screw, cam or similar mechanism to withdraw the deployment rods a desired distance independent of required tension. Thereafter, a tissue grip mechanism may be deployed over theanchors31 and onto thetissue layer portions32 gathered and secured to theanchors31 so as to secure the tissue layer portions together with theaccess hole25 closed or reduced. Theanchors31 may then be released from the tissue layer portions which are secured together as shown inFIGS. 20 and 21. Thereafter, thedeployment rods38 and anchors31 of each of the plurality ofanchor deployers26 may be proximally withdrawn fromrespective anchors31 and into thedistal section48 of thehousing28.
• In some cases, for such method embodiments, it may be desirable after proximally retracting theanchors31 anddeployment rods38 and gathering tissue of thetissue layer3 and prior to deploying the tissue grip, to release thetissue layer3 from theanchors31 and re-deploy theanchor deployers26 by re-extending thedeployment rods38 in a distal and radially outward direction and re-gripping thetissue layer3 about theaccess passage25 to reset the orientation and/or position of the anchors with respect to theaccess hole25 before proximally retracting theanchors31 anddeployment rods38 back into thehousing28. This may be particularly useful when the operator is not satisfied with the initial placement of theanchors31 about theaccess hole25 in thetissue layer3. Such repositioning of theanchors31 may be repeated as many times as is practical by the operator of thevascular closure device24.
• In some instances, theanchors31 may include thejaws34 that can be moved between an open state and a closed state as shown inFIGS. 9-10A. In such cases, securing thejaws34 of therespective anchors31 to thetissue layer3 may include inserting tissue of thetissue layer3 into thejaws34 while thejaws34 are in an open state and then closing thejaws34 to the closed state to grip the tissue layer between the opposed surfaces of thejaws34 as shown inFIG. 16A. In some cases, thejaws34 may include thetissue gripping teeth68 on the opposed surfaces of thejaws34 and gripping thetissue3 between the opposed surfaces of thejaws34 may include engaging and partially penetrating the tissue layer with thetissue gripping teeth68. In addition, for such embodiments, releasing theanchors31 from the tissue layer portions may include moving thejaws34 from the closed state to the open state such that the tissue is no longer gripped by the opposed surfaces of thejaws34 ortissue gripping teeth68 thereof.
• For some embodiments of thevascular closure device24, theanchors31 may include theshaft70 which has the sharpeneddistal end72 and which has an elongate configuration with an axial length greater than an outer transverse dimension as shown inFIG. 11. Theshaft70 may be configured to be actuated between the curved tissue gripping state as shown inFIG. 12 and the straightened state as shown inFIG. 11. For such embodiments, securing suchrespective anchors31 to thetissue layer3 may include inserting the sharpened distal ends72 of theshaft70 into thetissue layer3 with theshaft70 in a straightened state and actuating theshaft70 to move theshaft70 into a curved tissue gripping state about tissue of thefascia tissue layer3 as shown inFIG. 16B. For some such embodiments, releasing theanchors31 from the tissue layer portions may include actuating theshafts70 from the curved tissue gripping state to the straightened state and thereafter proximally retracting theshafts70 from the tissue layer portions.
• In some instances, deploying the tissue grip mechanism onto the tissue layer portions may include sliding the self-contracting ring27 in an expanded state from thedistal end52 of thehousing28 and allowing the self-contracting ring27 to contact to the relaxed state over thetissue layer portions3 as shown inFIGS. 20 and 22. The self-contracting ring27 may optionally include a non-circular cross section, such as a diamond-shaped cross section, to increase friction with thetissue bundle32. Such a self-contracting ring27 may also include a self-contracting ring embodiment27′ that includesbarbs76 which point upward and radially inward towards a longitudinal axislongitudinal axis88 of the self-contracting ring27′ as shown inFIGS. 8A-8c. Once deployed overtissue32 and allowed to self-contract to a relaxed constrained state, as shown inFIGS. 8A and 8B, thebarbs76 may penetrate into the gatheredtissue32 and prevent thelock ring27′ from sliding off of the gatheredtissue32 as shown inFIGS. 23 and 24. In some instances, deploying the tissue grip mechanism onto the gatheredtissue32 of thetissue layer portions3 may include applying thetissue adhesive30, such as cyanoacrylate to the gatheredtissue32 of the tissue layer portions as shown inFIGS. 20 and 21.FIG. 20 shows a tissue grip mechanism combination of the self-contracting ring27 disposed over the gatheredtissue32 as well as the tissue adhesive30 disposed thereon and in between different portions of thefascia tissue layer3.
• Referring again toFIGS. 15-24, some embodiments of a method for vascular closure may include disposing adistal end52 of thehousing28 of thevascular closure device24 to a position adjacent theaccess passage25 in thetissue layer3 and deploying a plurality ofanchor deployers26 from adistal section52 of thehousing28. The anchor deployers26 may be so deployed by distally advancingdeployment rods38 of the anchor deployers26 in a distal and radially outward direction from thehousing28 into the tissue layer in positions disposed about thepassage25 in thetissue layer3.Respective anchors31 of theanchor deployers26 may then be secured to thetissue layer3 in positions disposed about thepassage25 in thetissue layer3 as shown inFIGS. 16C-16D. Thedeployment rods38 may then be proximally retracted back into thedistal section48 of thehousing28 so as to draw theanchors31 and respective tissue layer portions secured thereto together adjacent thedistal section48 of thehousing28 to gather thetissue3 and close thepassage25 in thetissue layer3. Thereafter, the tissue grip embodiment may be deployed over theanchors31 and onto thetissue layer portions3 gathered and secured to theanchors31 so as to secure the tissue layer portions together with theaccess hole25 closed or reduced. Theanchors31 may then be detached from each of therespective deployment rods38 secured thereto and left in the patient secured to thetissue layer3. In some cases, theanchor deployers26 may include thereleasable junctions74 disposed between eachrespective deployment rod38 andanchor31 thereof. In such cases, detaching eachanchor31 from therespective deployment rod38 secured thereto may include heating atether78 of thereleasable junction74 until it melts. In some instances, theanchor deployers26 may be mechanically attached to theanchors31 via a quarter-turn lock. In such cases, a cam or similar mechanism in thehandle56 may be used to rotate each of the deployment rods38 a quarter turn or other suitable angular displacement to disengage thedeployment rods38 from theirrespective anchors31.
• Embodiments illustratively described herein suitably may be practiced in the absence of any element(s) 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 either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof, and various modifications are possible. The term “a” or “an” can refer to one of or a plurality of the elements it modifies (e.g., “a reagent” can mean one or more reagents) unless it is contextually clear either one of the elements or more than one of the elements is described. Thus, it should be understood that although embodiments have been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered within the scope of this disclosure.
• With regard to the above detailed description, like reference numerals used therein refer to like elements that may have the same or similar dimensions, materials and configurations. While particular forms of embodiments have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the embodiments of the invention. Accordingly, it is not intended that the invention be limited by the forgoing detailed description.

Claims (38)

What is claimed is:

1. A vascular closure device, comprising:

a housing having an elongate configuration with an axial length greater than a transverse dimension thereof, a proximal end, a distal end and a distal section;

a plurality of anchor deployers which are slidably disposed within the housing adjacent each other at the distal section of the housing and which are configured to extend and spread from the distal section of the housing, each anchor deployer comprising:

an deployment rod which is slidably disposed relative to the housing and which includes an elongate resilient configuration and a distal end that extends distally and radially from the distal section of the housing, and

an anchor which is secured to the distal end of the deployment rod and which is configured to grip tissue; and

a tissue grip which is deployable from the distal end of the housing.

2. The vascular closure device ofclaim 1 wherein the housing further comprises a guidewire lumen extending an axial length thereof.

3. The vascular closure device ofclaim 1 further comprising a handle secured to the proximal end of the housing.

4. The vascular closure device ofclaim 1 further comprising a deployment rod pusher which is spring loaded and biased towards a retracted position and which is operatively coupled to the deployment rods.

5. The vascular closure device ofclaim 4 wherein the deployment rod pusher is operatively coupled to a proximal end of the deployment rods and configured to extend the deployment rods in a distal direction upon actuation.

6. The vascular closure device ofclaim 5 wherein the deployment rods are configured to extend and retract simultaneously.

7. The vascular closure device ofclaim 1 wherein the tissue grip is disposed on the distal end of the housing around the anchor deployers and which is configured to compress and secure tissue portions relative to each other once deployed from the distal end of the housing.

8. The vascular closure device ofclaim 7 wherein the tissue grip comprises a lock ring disposed about the anchor deployers which includes a self-retracting coil with a central lumen which is sized to allow movement of the tissue portions while the self-retracting coil is in an expanded state and which has an interior surface of the central lumen that is configured to compress and secure the tissue portions relative to each other when in a retracted state.

9. The vascular closure device ofclaim 1 wherein the tissue grip comprises a tissue adhesive that may be dispensed from an outlet port in the distal end of the housing.

10. The vascular closure device ofclaim 9 wherein the tissue adhesive comprises cyanoacrylate.

11. The vascular closure device ofclaim 1 wherein the anchors comprise releasable anchors.

12. The vascular closure device ofclaim 11 wherein each of the releasable anchors comprises a jaw that can be moved between an open state and a closed state, each jaw further including an opposed pair of tissue gripping teeth.

13. The vascular closure device ofclaim 11 wherein each of the releasable anchors comprises a shaft having an elongate configuration with an axial length greater than an outer transverse dimension that is configured to be actuated between a curved tissue gripping state and a straightened state, the shaft further including a sharpened distal end.

14. The vascular closure device ofclaim 13 wherein the shaft comprises a shape memory metal that can be actuated between the curved tissue gripping state and the straightened state.

15. The vascular closure device ofclaim 14 wherein the shape memory metal of the shaft comprises nickel titanium alloy.

16. The vascular closure device ofclaim 13 wherein the shaft comprises a bi-metal structure that can be actuated between the curved tissue gripping state and the straightened state.

17. The vascular closure device ofclaim 1 wherein the anchors comprise detachable anchors and the anchor deployers comprise releasable junctions disposed between each detachable anchor and deployment rod secured thereto.

18. The vascular closure device ofclaim 17 wherein each of the detachable anchors comprises a proximally oriented barb.

19. The vascular closure device ofclaim 18 wherein the detachable anchors comprise a plurality of proximally oriented barbs.

20. The vascular closure device ofclaim 17 wherein the releasable junctions comprise a junction released by thermal detachment.

21. The vascular closure device ofclaim 17 wherein the releasable junctions comprise a junction released by mechanical detachment.

22. The vascular closure device ofclaim 1 further comprising a lateral surface configured to extend radially from a distal extension of the housing while the lateral surface is disposed within a blood vessel to provide a reference point between axial relative positions of the wall of the blood vessel and the anchors prior to deployment of the anchors.

23. The vascular closure device ofclaim 22 wherein the anchors can be deployed a predetermined axial distance from the wall of the blood vessel as measured from the lateral surface which is disposed against the wall of the blood vessel.

24. A method for vascular closure, comprising:

disposing a distal end of a housing of a vascular closure device to a position adjacent a passage in a tissue layer;

deploying a plurality of anchor deployers from a distal section of the housing by distally advancing deployment rods of the anchor deployers in a distal and radially outward direction from the housing into the tissue layer in positions disposed about the passage in the tissue layer;

securing respective anchors of the anchor deployers to the tissue layer in positions disposed about the passage in the tissue layer;

proximally retracting the deployment rods back into the distal section of the housing so as to draw the anchors and respective tissue layer portions secured thereto together adjacent the distal section of the housing;

deploying a tissue grip over the anchors and onto the tissue layer portions secured to the anchors so as to secure the tissue layer portions together; and

releasing the anchors from the tissue layer portions.

25. The method ofclaim 24 further comprising releasing the anchors from the tissue layer portions prior to deploying the tissue grip and re-deploying the plurality of anchor deployers from a distal section of the housing by distally advancing deployment rods of the anchor deployers in a distal and radially outward direction from the housing into the tissue layer in positions disposed about the passage in the tissue layer, re-securing respective anchors of the anchor deployers to the tissue layer in positions disposed about the passage in the tissue layer; and proximally retracting the deployment rods back into the distal section of the housing a second time so as to draw the anchors and respective tissue layer portions secured thereto together adjacent the distal section of the housing.

26. The method ofclaim 24 wherein the anchors comprise jaws that can be moved between an open state and a closed state, wherein securing respective anchors to the tissue layer comprises inserting tissue of the tissue layer into the jaws while in an open state and then closing the jaws to the closed state to grip the tissue layer.

27. The method ofclaim 26 wherein releasing the anchors from the tissue layer portions comprises moving the jaws from the closed state to the open state.

28. The method ofclaim 24 wherein the anchors comprise a shaft including a sharpened distal end and having an elongate configuration with an axial length greater than an outer transverse dimension, the shaft being configured to be actuated between a curved tissue gripping state and a straightened state, and wherein securing respective anchors to the tissue layer comprises inserting the sharpened distal ends of the shaft into the tissue layer with the shaft in a straightened state and actuating the shaft to move the shaft into a curved tissue gripping state.

29. The method ofclaim 28 wherein releasing the anchors from the tissue layer portions comprises actuating the shafts from the curved tissue gripping state to the straightened state and proximally retracting the shafts from the tissue layer portions.

30. The method ofclaim 24 further comprising proximally withdrawing deployment rods and anchors of each of the plurality of anchor deployers from respective anchors and into the distal section of the housing.

31. The method ofclaim 24 wherein deploying the tissue grip onto the tissue layer portions comprises sliding a self-contracting ring in an expanded state from a distal end of the housing and allowing the self-contracting ring to contact to a relaxed state over the tissue layer portions.

32. The method ofclaim 24 wherein deploying the tissue grip onto the tissue layer portions comprises applying a tissue adhesive to the tissue layer portions.

33. The method ofclaim 32 wherein applying a tissue adhesive to the tissue layer portions comprises applying cyanoacrylate adhesive to the tissue layer portions.

34. A method for vascular closure, comprising:

disposing a distal end of a housing of a vascular closure device to a position adjacent a passage in a tissue layer;

deploying a plurality of anchor deployers from a distal section of the housing by distally advancing deployment rods of the anchor deployers in a distal and radially outward direction from the housing into the tissue layer in positions disposed about the passage in the tissue layer;

securing respective anchors of the anchor deployers to the tissue layer in positions disposed about the passage in the tissue layer;

proximally retracting the deployment rods back into the distal section of the housing so as to draw the anchors and respective tissue layer portions secured thereto together adjacent the distal section of the housing;

deploying a tissue grip over the anchors and onto the tissue layer portions secured to the anchors so as to secure the tissue layer portions together; and

detaching each anchor from the respective deployment rod secured thereto.

35. The method ofclaim 34 wherein the anchor deployers comprise releasable junctions disposed between each respective deployment rod and anchor thereof, and wherein detaching each anchor from the respective deployment rod secured thereto comprises heating a tether of the releasable junction until it melts.

36. A method for vascular closure, comprising:

disposing a vascular closure device adjacent a passage in a tissue layer which is disposed above and adjacent an access hole in a blood vessel of a patient;

deploying a plurality of anchors from a distal section of the vascular closure device in a distal and radially outward direction therefrom and engaging the tissue layer in positions disposed about the passage in the tissue layer with the anchors;

securing the anchors to the tissue layer in the positions disposed about the passage in the tissue layer;

proximally retracting the anchors closer together so as to draw the anchors and respective tissue layer portions secured thereto together thereby closing the passage in the tissue layer; and

deploying a tissue grip onto the tissue layer portions drawn together by the anchors so as to secure the drawn together tissue layer portions thereby closing the passage in the tissue layer and achieving vascular closure of the access hole in the blood vessel.

37. The method ofclaim 36 wherein deploying the tissue grip onto the tissue layer portions drawn together by the anchors comprises deploying a lock ring onto the drawn together tissue layer portions.

38. The method ofclaim 36 wherein deploying the tissue grip onto the tissue layer portions drawn together by the anchors comprises deploying a tissue adhesive onto the drawn together tissue layer portions.

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