US20190142403A1 - Tissue closure device - Google Patents
Tissue closure device Download PDFInfo
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- US20190142403A1 US20190142403A1 US16/190,694 US201816190694A US2019142403A1 US 20190142403 A1 US20190142403 A1 US 20190142403A1 US 201816190694 A US201816190694 A US 201816190694A US 2019142403 A1 US2019142403 A1 US 2019142403A1
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Abstract
Description
- 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.
- 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.
- 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.
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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 portion 6-6 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 alonglines 7D-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 alonglines 10A-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 alonglines 12A-12A ofFIG. 12 . -
FIG. 13 is an elevation view of a detachable anchor embodiment. -
FIG. 13A is an enlarged view of the encircledportion 13A-13A of the detachable anchor embodiment ofFIG. 13 . -
FIG. 13B is a transverse cross section of the deployment rod embodiment ofFIG. 13 taken alonglines 13B-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 alonglines 14A-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.
- 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 of
FIGS. 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 device 10 is introduced percutaneously over aguide wire 8 into a blood vessel/artery 5, through theskin 1 and thefascia lata 2 of a patient. An optional anvil member 9 may be arranged inside theblood vessel 5 to create a reference point along an axial orientation to theengagement members 11 and/or for controlling bleeding from an inner lumen of theartery 5. Theengagement members 11 may then be placed and released through thevascular closure device 10 and may attach tofascia tissue 3 proximate to theblood vessel 5 and may involve the fascia membrane 3 (fascia iliacus), but, in some instances, not awall 22 of theblood vessel 5. Theengagement members 11 may for example be pushed out of thevascular closure device 10 and into thefascia membrane 3 using deployment members provided aspusher rods 12 arranged in independent lumens provided with thevascular closure device 10, for example through a pusher assembly in a common lumen that simultaneously deploys allengagement members 11, through a spring-loaded mechanism or the like. For some embodiments, theengagement members 11 may be connected with a single filament such as a suture or a plurality of filaments or sutures 13. InFIG. 1 there is further shown afemoral vein 4, afemoral nerve 6 and adjacent/interstitial tissues 7. - With further reference to
FIGS. 2A and 2B , thesuture 13 may for example be routed through each of theengagement members 11 in sequence. In particular, onesuture 13 may be looped through each of theengagement members 11 in sequence, or aseparate suture 13 may be attached to eachengagement member 11. The tissue,e.g. fascia membrane 3, may then pulled together in a radially inward direction towards an access passage in thefascia layer 3 with thesuture 13 connected to theengagement members 11. When pulled together, the tissue/fascia membrane 3 is tightened towards the center and the access passage therethrough and may then create a tissue lock, thereby indirectly sealing the access hole in theartery 5. That is, a distance between the initial position of theengagement members 11 and a distance between the engagement members once theengagement members 11 have been moved radially inward towards each other is thereby reduced. When tightening thefascia membrane 3 the anvil member 9 may be removed from theartery 5. - Referring to
FIGS. 2C and 2D , an embodiment of a vascular closure sequence is shown whereby a passage through awall 22 of thevessel 5 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 artery 5, is disposed in general alignment with a passage through thefascia tissue layer 3 disposed proximate to an outer surface of thefemoral artery 5. For this particular exemplary embodiment, the tissue layer disposed outside of and proximate to the outer surface of thefemoral artery 5 is thefascia iliacus 3. 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 thetissue 3 andartery 5. - In addition, in some cases, the
tissue layer 3 may be disposed sufficiently proximate the outside surface of theblood vessel 5 such that gathering and approximation of thefascia tissue 3 which is disposed about the passage through thetissue 3 so as to close the passage through the tissue/fascia membrane 3 and form a tissue lock is sufficient to tighten and displace the closed gathered tissue/fascia membrane 3 against the outer surface of theartery 5 which is adjacent the passage through theartery 5 as shown inFIG. 2D . - When the gathered
tissue 3 has been displaced and deflected so as to be disposed against the passage of theartery 5 and wall of theartery 5 disposed about the passage in theartery 5, this mechanical approximation will typically be sufficient in order to achieve a clinically sufficient slowing or stoppage of blood leakage from the passage in theartery 5 in order to permit closure of an access site through the patient'sskin 1 adjacent the passages. In some instances, an inner surface of thetissue layer 3 disposed proximate to the outer surface of theblood vessel 5 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 to
FIGS. 3A and 3B , there is conceptually illustrated an engagement member, exemplified as ananchor element 15. InFIG. 3A , theanchor element 15 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 membrane 3 to promote engagement.FIG. 3B shows theanchor element 15 after motion has been reversed toward the deployment point, and theanchor element 15 has embedded into the tissue/fascia membrane 3. That is, atip 17 of theanchors element 15 is in one embodiment hook-shaped, so that it easily slides outward without engaging the tissue/fascia membrane 3. However, once theanchor element 15 is retracted, at least thetip 17 of theanchor element 15 is adapted to mechanically engage with the tissue/fascia membrane 3. -
FIGS. 4A and 4B conceptually illustrate the operation of an anvil member exemplified as adeployable positioning feature 20. InFIG. 4A ,deployable positioning feature 20 may be inserted through thewall 22 and into the interior volume of the blood vessel, such as thefemoral artery 5. Thedeployable positioning feature 20 may be structured similar to an umbrella (using a mesh material), where thedeployable positioning feature 20 in a radially collapsed form may be inserted into theartery 5. Once within theartery 5, with further reference toFIG. 4B , thedeployable positioning feature 20 may be “unfolded” and radially expanded from the collapsed form such that a total surface area proximate to the longitudinal axis of thedeployable positioning feature 20 is increased and thus may be retracted towards the interior wall of theartery 5. Accordingly, a reference point may be thereby established for further operation of thevascular closure device 10. - For the vascular
closure device embodiments 24 shown inFIGS. 5-24 , a mechanical “grabber” type device may be used to grab thefascia tissue layer 3 around anaccess hole 25 in the fascia (seeFIG. 15 ), pull it together, and apply a tissue grip type of device such aslock ring 27 or other tissue grip type retention mechanism such as a tissue adhesive 30 directly to the tissue of thefascia 3 to secure the gatheredfascia tissue 32 disposed around theaccess hole 25 in the closed position to form a tissue lock and achieve vascular closure of an access hole in theadjacent vessel 5.FIGS. 5-24 illustrate embodiments of such grabber-typevascular closure devices 24. The arms, also referred to herein asanchor deployers 26, may be initially retracted into ahousing 28 to achieve a low profile. Once in place above thefascia tissue layer 3, thearms 26 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), thearms 26 may be configured to spread out into a radially dispersed pattern disposed around theaccess hole 25 in thefascia tissue layer 3. - The
arms 26 may then engage thefascia tissue layer 3 at two or more points around theaccess hole 25. This engagement may be accomplished by ananchor 31 such as asmall jaw 34 or the like mounted on thedistal end 36 of adeployment rod 38 of eacharm 26 and adapted to grab thefascia 3, or asmall hook 15, 40 (seeFIGS. 3A and 12 ) could be used to engage thefascia 3. Other similar mechanisms may also be used. Once eacharm 26 of thevascular closure device 24 has secured thefascia 3, thehousing 28 may be advanced down over thearms 26, or the arms retracted proximally into thehousing 28, thereby pulling the distal ends 36 of thearms 26 together in a radially inward and proximal direction, approximating the edges of thefascia tissue layer 3 disposed about theaccess hole 25 therein, and closing or minimizing theaccess hole 25. - In addition, the retention mechanism, such as a tissue grip mechanism that holds the approximated edges of the gathered
fascia tissue 32 in this gathered configuration, such as the ring orclip 27, may then be deployed onto the gatheredtissue 32. Thereafter, thearms 26 or anchors 31 disposed thereon may be disengaged from thefascia tissue layer 3 and thevascular closure device 24 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 ring 27 that is stretched onto the outside of thehousing 28 about an outside circumference of thearms 26 or outside of a translation track of thearms 26. Thelock ring 27, which may include an elastic and resilient self-contractinglock ring 27, may be pushed off of thehousing 28 by adistal end 42 of a larger, concentricouter tube 44 that lies more proximal over aninner tube 46 of thehousing 28. In some cases, theouter tube 44 may be actuated to advance distally relative to theinside tube 46 and deploy thelock ring 27 by advancing a lockring actuator lever 47 which may be operatively coupled to theouter tube 44. Once pushed off theinside tube 46 of thehousing 28 and onto the gatheredtissue 32, such anelastic coil 27 may self-contract to circumferentially compress the gatheredtissue 32 and brought together by thearms 26 in an inner radial direction and retain the gatheredtissue 32 in a bunched or gathered configuration, thereby closing or reducing theaccess hole 25. - Such
elastic coil embodiments 27 may be made from high strength resilient materials such as stainless steel, nitinol, or the like. Someelastic coil embodiments 27 may also be made from or include bioresorbable and/or biodegradable materials. In some embodiments, the gatheredtissue 32 may be held together by a biocompatible, rapidly curing tissue adhesive, such as cyanoacrylate, dispensed from adistal section 48 of thehousing 28. Such a tissue adhesive 30 may be dispensed as the gathered tissue of thefascia tissue layer 3 is coming together, to facilitate the apposition of surfaces containing tissue adhesive 30, or the tissue adhesive 30 may be dispensed onto the gatheredtissue 32 once the tissue is bunched together. - Referring to
FIGS. 5 and 6 , some embodiments of thevascular closure device 24 may include thehousing 28 having an elongate configuration with an axial length greater than a transverse dimension thereof. Such ahousing 28 may further include aproximal end 50, adistal end 52 and adistal section 48. A plurality ofanchor deployers 26 are slidably disposed within thehousing 28 adjacent each other at thedistal section 48 of thehousing 28 and are configured to extend and spread from thedistal section 48 of thehousing 28. Each of theanchor deployers 26 may include thedeployment rod 38 which is slidably disposed relative to thehousing 28 and which includes an elongate resilient configuration. Eachdeployment rod 38 may also include thedistal end 36 that extends distally and radially outward from thedistal section 48 of thehousing 28 so as to spread out from other the distal ends 36 of thedeployment rods 38. In some cases, thedeployment rods 38 may be configured to extend distally at the same time or simultaneously. Eachanchor deployer 26 may also include theanchor 31 which is secured to thedistal end 36 of thedeployment rod 38 and which is configured to grip tissue such as the tissue of afascia tissue layer 3. The vascularclosure device embodiment 24 may further include thelock ring 27 which may be deployable from thedistal end 52 of thehousing 28. The vascular closure device ofFIG. 5 includes 4anchor deployers 26, however any suitable number ofanchor deployers 26 may be used. Some such vascularclosure device embodiments 24 may include about 2anchor deployers 26 to about 8anchor deployers 26, more specifically, about 3anchor deployers 26 to about 5anchor deployers 26. For some embodiments, it may be desirable for thedeployment rods 38 to have a rectangular transverse cross section profile to facilitate distal and radially outward extension while maintaining lateral stability. In some instances, thedeployment rod embodiments 38 may a generally flattened cross section profile with a radial transverse dimension that is less than a circumferentially oriented transverse dimension. - In some cases, the
housing 28 may further include aguidewire lumen 54 extending an axial length thereof and ahandle 56 secured to theproximal end 50 of thehousing 28. Adeployment rod pusher 58 which may optionally be spring loaded with a resilient member such as aspring 60 in either a distally biased or proximally biased direction may be operatively coupled to thedeployment rods 38 for actuation thereof. For deploymentrod pusher embodiment 58 which are proximally biased this may correspond to a bias with thedeployment rods 38 biased towards a retracted position which may be overcome by manual pressure in a distal direction against thedeployment rod pusher 58. The spring, such asspring 60 shown inFIG. 1 , may be used to provide such a resilient biasing force on thedeployment rod pusher 58. As shown, thedeployment rod pusher 58 is operatively coupled to respective proximal ends of thedeployment rods 38 and optionally configured to extend thedeployment rods 38 simultaneously in a distal direction upon actuation. - In some instances, embodiments of a tissue grip mechanism may be disposed on the
distal end 52 of thehousing 28 around theanchor deployers 26 but generally not in contact with theanchor deployers 26 when in an undeployed state. The tissue grip mechanism may be configured to compress and secure gatheredtissue portions 32 relative to each other in some cases. For such embodiments, once the tissue grip is deployed from thedistal end 52 of thehousing 28 over theanchor deployers 26 andrespective anchors 31 thereof and onto the tissue which has been gathered and bunched by the proximally retractedanchor deployers 26, 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 ring 27 disposed about the anchor deployers 26 in the form of a self-retractingcoil 27 with acentral lumen 62 which may be sized to allow movement of the gatheredtissue portions 32 disposed therein while the self-retractingcoil 27 is in an expanded state as shown inFIG. 7C . Theinterior surface 64 of thecentral lumen 62 may be configured to compress and secure the gatheredtissue portions 32 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 adhesive 30 that may be dispensed from an outlet port, such as adistal port 66 of theguidewire lumen 54, in thedistal end 52 of thehousing 28 as shown inFIGS. 20 and 21 . For some embodiments, such as the tissue adhesive 30 may include cyanoacrylate, fibrin glue, PEG-based polymers or the like. - In general, the tissue grip embodiments such as
lock ring 27 and tissue adhesive 30 may optionally include a tissue engagement feature that is configured to stick to a surface of the gatheredtissue 32 such as with the tissue adhesive 30 forming a bond with the gatheredtissue 32 or sharpinner edge 64 of the diamond profiledlock ring 27 mechanically impinging the gatheredtissue 32 so as to effectively secure the tissue portions together. Such tissue engagement features may further include features which may be mechanically captured within the gatheredtissue 32 such as thebarbs 76 of the “castle shaped”lock ring 27′ shown inFIG. 8A . Thebarbs 76 are configured to penetrate the gatheredtissue 32 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 gatheredtissue 32 once deployed. - For some embodiments of
vascular closure devices 24 discussed herein, theanchors 31 may include releasable anchors. For example, some releasable anchor embodiments may include thejaw 34 that can be moved between an open state and a closed state, eachjaw 34 further including an opposed pair oftissue gripping teeth 68 as shown in theanchor embodiment 31 ofFIGS. 9-10A and 16A .Such anchors 31 that include ajaw 34, may be actuated by apull wire 69 or the like that may apply tension to a hingedlever 71 at a proximal end of a hingedjaw portion 73 of thejaw 34 as shown inFIG. 10 . In some instances, thepull wire 69 or any other suitable actuation mechanism may be actuated by anactuation lever 59 which may optionally be disposed on thedeployment rod pusher 58 shown inFIG. 5 . - For some releasable anchor
embodiments 31, each of the releasable anchors may have ashaft 70 with an elongate configuration having an axial length greater than an outer transverse dimension of theshaft 70. Thereleasable anchor 31 may be configured to be actuated between a curved tissue gripping state having the curveddistal end 40 as shown inFIG. 12 and a straightened state as shown inFIG. 11 . In some cases, theshaft 70 of thereleasable anchor 31 may further include a sharpeneddistal end 72 which is configured to penetrate tissue such as thefascia tissue layer 3 when pushed distally, sharpeneddistal end 72 first, into thefascia tissue layer 3. For some embodiments, theshaft 70 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 theshaft 70 may include nickel titanium alloy. For other such embodiments, theshaft 70 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 ends 36 of the
deployment rods 38 andanchor deployers 26. Referring toFIGS. 13-14A ,detachable anchor embodiments 31 are shown wherein theanchor deployers 26 includereleasable junctions 74 disposed between each suchdetachable anchor 31 andrespective deployment rod 38 which is secured thereto. In some cases, thedetachable anchor embodiments 31 may include a proximally orientedbarb 76, and in some cases, a plurality of proximally orientedbarbs 76. For some embodiments, thereleasable junctions 74 used to detach suchdetachable anchors 31 may include areleasable junction 74 released by thermal detachment, mechanical detachment or any other suitable detachment mechanism. Thereleasable junction embodiment 74 shown inFIG. 13A includes atether 78 which secured between thedistal end 36 of thedeployment rod 38 andanchor 31 and which may be melted by aheater element 80 disposed about thetether 78. Theheater element 80 may be actuated by applying electrical power from apower source 82 to theheater element 80 through a first electrically conductingwire 84 and a second electrically conductingwire 86 in electrical communication between thepower source 82 and theheater element 80. - Some embodiments of the vascular closure devices discussed herein may include a lateral surface configured to extend radially from a distal extension of the
housing 28 while the lateral surface is disposed within ablood vessel 5 such as the anvil 9 shown inFIG. 1 and thedeployable positioning feature 20 shown inFIGS. 4A and 4B and discussed above. Such alateral surface 9, 20 that extends radially may be used to provide a reference point between relative axial positions of thewall 22 of theblood vessel 5 and theanchors 31 prior to deployment of theanchors 31. In some cases, embodiments of theanchors 31 may be deployed a predetermined axial distance from thewall 22 of theblood vessel 5 as measured from thelateral surface 9, 20 which is disposed against thewall 22 of theblood vessel 5. - Referring generally to
FIGS. 15-24 , some embodiments of a method for vascular closure may include disposing thedistal end 52 of thehousing 28 of thevascular closure device 24 to a position adjacent thepassage 25 in thetissue layer 3 and deploying a plurality ofanchor deployers 26 from adistal section 48 of thehousing 28. The anchor deployers 26 may be so deployed by distally advancingdeployment rods 38 of the anchor deployers 26 in a distal and radially outward direction from thehousing 28 into thetissue layer 3 in positions disposed about thepassage 25 in thetissue layer 3. Respective anchors 311 of theanchor deployers 26 may then be secured to thetissue layer 3 in positions disposed about thepassage 25 in thetissue layer 3 as shown inFIGS. 16A-16B . Thedeployment rods 38 may then be proximally retracted back into thedistal section 48 of thehousing 28 so as to draw theanchors 31 and respective tissue layer portions secured thereto together adjacent thedistal section 48 of thehousing 28 to gather thetissue 3 and close thepassage 25 in thetissue layer 3. 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 theanchors 31 and onto thetissue layer portions 32 gathered and secured to theanchors 31 so as to secure the tissue layer portions together with theaccess hole 25 closed or reduced. Theanchors 31 may then be released from the tissue layer portions which are secured together as shown inFIGS. 20 and 21 . Thereafter, thedeployment rods 38 and anchors 31 of each of the plurality ofanchor deployers 26 may be proximally withdrawn fromrespective anchors 31 and into thedistal section 48 of thehousing 28. - In some cases, for such method embodiments, it may be desirable after proximally retracting the
anchors 31 anddeployment rods 38 and gathering tissue of thetissue layer 3 and prior to deploying the tissue grip, to release thetissue layer 3 from theanchors 31 and re-deploy theanchor deployers 26 by re-extending thedeployment rods 38 in a distal and radially outward direction and re-gripping thetissue layer 3 about theaccess passage 25 to reset the orientation and/or position of the anchors with respect to theaccess hole 25 before proximally retracting theanchors 31 anddeployment rods 38 back into thehousing 28. This may be particularly useful when the operator is not satisfied with the initial placement of theanchors 31 about theaccess hole 25 in thetissue layer 3. Such repositioning of theanchors 31 may be repeated as many times as is practical by the operator of thevascular closure device 24. - In some instances, the
anchors 31 may include thejaws 34 that can be moved between an open state and a closed state as shown inFIGS. 9-10A . In such cases, securing thejaws 34 of therespective anchors 31 to thetissue layer 3 may include inserting tissue of thetissue layer 3 into thejaws 34 while thejaws 34 are in an open state and then closing thejaws 34 to the closed state to grip the tissue layer between the opposed surfaces of thejaws 34 as shown inFIG. 16A . In some cases, thejaws 34 may include thetissue gripping teeth 68 on the opposed surfaces of thejaws 34 and gripping thetissue 3 between the opposed surfaces of thejaws 34 may include engaging and partially penetrating the tissue layer with thetissue gripping teeth 68. In addition, for such embodiments, releasing theanchors 31 from the tissue layer portions may include moving thejaws 34 from the closed state to the open state such that the tissue is no longer gripped by the opposed surfaces of thejaws 34 ortissue gripping teeth 68 thereof. - For some embodiments of the
vascular closure device 24, theanchors 31 may include theshaft 70 which has the sharpeneddistal end 72 and which has an elongate configuration with an axial length greater than an outer transverse dimension as shown inFIG. 11 . Theshaft 70 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 anchors 31 to thetissue layer 3 may include inserting the sharpened distal ends 72 of theshaft 70 into thetissue layer 3 with theshaft 70 in a straightened state and actuating theshaft 70 to move theshaft 70 into a curved tissue gripping state about tissue of thefascia tissue layer 3 as shown inFIG. 16B . For some such embodiments, releasing theanchors 31 from the tissue layer portions may include actuating theshafts 70 from the curved tissue gripping state to the straightened state and thereafter proximally retracting theshafts 70 from the tissue layer portions. - In some instances, deploying the tissue grip mechanism onto the tissue layer portions may include sliding the self-
contracting ring 27 in an expanded state from thedistal end 52 of thehousing 28 and allowing the self-contracting ring 27 to contact to the relaxed state over thetissue layer portions 3 as shown inFIGS. 20 and 22 . The self-contracting ring 27 may optionally include a non-circular cross section, such as a diamond-shaped cross section, to increase friction with thetissue bundle 32. Such a self-contracting ring 27 may also include a self-contracting ring embodiment 27′ that includesbarbs 76 which point upward and radially inward towards a longitudinal axislongitudinal axis 88 of the self-contracting ring 27′ as shown inFIGS. 8A-8 c. Once deployed overtissue 32 and allowed to self-contract to a relaxed constrained state, as shown inFIGS. 8A and 8B , thebarbs 76 may penetrate into the gatheredtissue 32 and prevent thelock ring 27′ from sliding off of the gatheredtissue 32 as shown inFIGS. 23 and 24 . In some instances, deploying the tissue grip mechanism onto the gatheredtissue 32 of thetissue layer portions 3 may include applying thetissue adhesive 30, such as cyanoacrylate to the gatheredtissue 32 of the tissue layer portions as shown inFIGS. 20 and 21 .FIG. 20 shows a tissue grip mechanism combination of the self-contracting ring 27 disposed over the gatheredtissue 32 as well as the tissue adhesive 30 disposed thereon and in between different portions of thefascia tissue layer 3. - Referring again to
FIGS. 15-24 , some embodiments of a method for vascular closure may include disposing adistal end 52 of thehousing 28 of thevascular closure device 24 to a position adjacent theaccess passage 25 in thetissue layer 3 and deploying a plurality ofanchor deployers 26 from adistal section 52 of thehousing 28. The anchor deployers 26 may be so deployed by distally advancingdeployment rods 38 of the anchor deployers 26 in a distal and radially outward direction from thehousing 28 into the tissue layer in positions disposed about thepassage 25 in thetissue layer 3.Respective anchors 31 of theanchor deployers 26 may then be secured to thetissue layer 3 in positions disposed about thepassage 25 in thetissue layer 3 as shown inFIGS. 16C-16D . Thedeployment rods 38 may then be proximally retracted back into thedistal section 48 of thehousing 28 so as to draw theanchors 31 and respective tissue layer portions secured thereto together adjacent thedistal section 48 of thehousing 28 to gather thetissue 3 and close thepassage 25 in thetissue layer 3. Thereafter, the tissue grip embodiment may be deployed over theanchors 31 and onto thetissue layer portions 3 gathered and secured to theanchors 31 so as to secure the tissue layer portions together with theaccess hole 25 closed or reduced. Theanchors 31 may then be detached from each of therespective deployment rods 38 secured thereto and left in the patient secured to thetissue layer 3. In some cases, theanchor deployers 26 may include thereleasable junctions 74 disposed between eachrespective deployment rod 38 andanchor 31 thereof. In such cases, detaching eachanchor 31 from therespective deployment rod 38 secured thereto may include heating atether 78 of thereleasable junction 74 until it melts. In some instances, theanchor deployers 26 may be mechanically attached to theanchors 31 via a quarter-turn lock. In such cases, a cam or similar mechanism in thehandle 56 may be used to rotate each of the deployment rods 38 a quarter turn or other suitable angular displacement to disengage thedeployment rods 38 from theirrespective anchors 31. - 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)
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US10639020B2 (en) | 2015-09-28 | 2020-05-05 | M-V Arterica AB | Vascular closure device |
US11179145B2 (en) | 2017-11-16 | 2021-11-23 | M-V Arterica AB | Collapsible tube for hemostasis |
IT202000020383A1 (en) * | 2020-08-25 | 2022-02-25 | Biodismed S R L | MEDICAL DEVICE FOR MECHANICAL HEMOSTASIS OF BLOOD VESSELS IN VIDEO-ASSISTED EMERGENCY SURGERY |
US11938288B2 (en) | 2019-11-19 | 2024-03-26 | Arterica Inc. | Vascular closure devices and methods |
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US20070083231A1 (en) * | 2005-10-07 | 2007-04-12 | Benjamin Lee | Vascular closure |
US9089311B2 (en) * | 2009-01-09 | 2015-07-28 | Abbott Vascular Inc. | Vessel closure devices and methods |
US9295463B2 (en) * | 2009-10-08 | 2016-03-29 | Covidien Lp | Shape memory fasteners and method of use |
EP2811913B1 (en) * | 2012-01-24 | 2017-11-01 | St. Jude Medical Puerto Rico LLC | Bioresorbable tip with low force release |
WO2017019525A1 (en) * | 2015-07-24 | 2017-02-02 | The Johns Hopkins University | Method and device for tissue acquisition or closure |
CN108135594B (en) * | 2015-09-28 | 2022-04-05 | 阿特里卡有限公司 | Vascular closure device |
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- 2018-11-14 US US16/190,694 patent/US20190142403A1/en active Pending
- 2018-11-14 WO PCT/SE2018/051173 patent/WO2019098922A1/en active Application Filing
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10639020B2 (en) | 2015-09-28 | 2020-05-05 | M-V Arterica AB | Vascular closure device |
US11723639B2 (en) | 2015-09-28 | 2023-08-15 | Arterica Inc. | Vascular closure device |
US11179145B2 (en) | 2017-11-16 | 2021-11-23 | M-V Arterica AB | Collapsible tube for hemostasis |
US11938288B2 (en) | 2019-11-19 | 2024-03-26 | Arterica Inc. | Vascular closure devices and methods |
IT202000020383A1 (en) * | 2020-08-25 | 2022-02-25 | Biodismed S R L | MEDICAL DEVICE FOR MECHANICAL HEMOSTASIS OF BLOOD VESSELS IN VIDEO-ASSISTED EMERGENCY SURGERY |
EP3960113A1 (en) * | 2020-08-25 | 2022-03-02 | Biodismed s.r.l | Medical device for mechanical hemostasis of blood vessels in video assisted emergency surgery |
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US20240108321A1 (en) | 2024-04-04 |
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