Blood vessel closure system, device and method

Abstract

Provided herein are closure devices and systems as well as methods of using the same for facilitating the closing of openings in blood vessels following interventional medical procedures. Further provided herein are systems for treating a blood vessel, which include a closure device and one or more of: an access sheath, a reverse flow device and a suture cutter unit.

Description

[0001] BLOOD VESSEL CLOSURE SYSTEM, DEVICE AND METHOD

[0002] TECHNICAL FIELD

[0003] The present disclosure relates generally to devices, systems and methods for treating a blood vessel. More specifically, the present disclosure relates to a closure device, system and method for closing an opening in a blood vessel, such as a carotid artery.

[0004] BACKGROUND

[0005] Percutaneous Trans Carotid Stenting (PTCS) is a minimally invasive procedure used to treat carotid artery disease. Carotid artery disease occurs when the carotid arteries, which supply blood to the brain, become narrowed or blocked due to a buildup of plaque. This narrowing can lead to strokes or transient ischemic attacks (TIAs), also known as "mini-strokes."

[0006] During the PTCS procedure (also referred to generally as percutaneous transluminal carotid angioplasty (PTCA)), a catheter is introduced to the vascular system at an access location and guided through the vascular system to a target location. In an arterial catheterization procedure, a relatively small percutaneous incision or puncture is made in the femoral, neck or other artery and a catheter is inserted therethrough and directed to the carotid artery (directly or along an arterial path).

[0007] When vascular access is no longer required, and the introducer sheath is removed, closure of the blood vessel should be performed, to stop bleeding. Some methods for providing hemostasis include applying external pressure near and upstream from the puncture site, for example, by manual compression, use of bioabsorbable fasteners, sealing bodies, placement of thrombogenic material, such as collagen, at the superficial arterial wall over the puncture site. Nevertheless, such methods are cumbersome, difficult to apply, time consuming, and in some instances may result in side effects, such as, vascular occlusion, thrombus formation, stenosis, infection, adverse reactions to the collagen or other implant, and the like.

[0008] Additional blood vessel closure method includes suturing of the vessel. Such a procedure involves the use of a suture and needles, to physically close the opening in the vessel. To this aim, directing the needles through the blood vessel wall at a significant di stance from the puncture site is needed, such that the suture is well anchored in the tissue and can provide tight closure. Additionally, needles deployment should take place when the device is properly positioned relative to the vessel wall.

[0009] Therefore, there is a need in the art for enhanced suturing systems, devices and methods for facilitating closure of an incision or opening in blood vessels walls, and in particular, in a wall of the carotid artery, in a safe, reliable and cost effective manner.

[0010] SUMMARY

[0011] Aspects of the disclosure, according to some embodiments thereof, relate generally to devices, systems and methods for closing or suturing openings in blood vessels (e.g., the carotid artery) after interventional medical procedures, such as, percutaneous transcarotid stenting (PTAC) procedures.

[0012] In some embodiments, the advantageous devices and systems disclosed herein are configured to provide a minimally invasive, safe, reliable and cost effective means for suturing an opening in the blood vessel.

[0013] In some embodiments, there is provided herein a closure device, which includes an elongated body, including at a distal region thereof at least one suture deployment mechanism. In some embodiments, the suture deployment mechanism includes two at least partially hollow retractable suturing needles configured to hold a suture or pass a suture within an internal space therewithin, and a hinged and rotatable / pivotable anchor, configured to secure the distal portion of the closure device within the artery, to accept the distal ends (e.g., tips) of the suturing needles received or passed therethrough, and to facilitate the passing of a suture therebetween. In some embodiments, the suturing device may include more than two needles, for example four needles.

[0014] Further provided are systems, kits and methods for performing or facilitating interventional treatment procedures, such as, for example, PTAC procedures, the systems and kits include the closure device disclosed herein and one or more of: a reverse flow device, a catheter / sheath (e.g., transcarotid access catheter), a guidewire, a distal balloon and / or filter, a suture cutter unit, and the like, or any combinations thereof.

[0015] According to some embodiments, there is provided a closure device for deploying a suture on or around an opening in a blood vessel, the closure device includes: a proximal portion and a distal portion, at least part of the distal portion being configured to be positioned within the blood vessel; at least one suture deployment mechanism positioned at the distal portion of the closure device, the at least one suture deployment mechanism including: at least one anchoring element configured for reversible transition between a closed state and an open state, and configured, when in the open state, to secure the at least part of the distal portion of the closure device within the blood vessel and to facilitate passing of a suture therethrough; at least two suturing needles configured for reversible deployment from the distal portion of the closure device; and at least one snare needle including a snare portion configured for engagement with the suture; wherein the at least two suturing needles include at least one giver needle and at least one receiver needle, and wherein the at least one snare needle is configured for reversible deployment from the at least one receiver needle.

[0016] According to some embodiments, the at least one anchoring element may be pivotally deployable.

[0017] According to some embodiments, the at least one anchoring element may include one or more internal passages. The one or more internal passages may include a first internal passage configured to allow passing of the suture therewithin or therethrough.

[0018] According to some embodiments, the snare needle may be configured for passing through the first internal passage, optionally both before and after the engagement with the suture.

[0019] According to some embodiments, passing the suture through the first internal passage may include passing the snare needle through the first internal passage with the suture being engaged with the snare portion of the snare needle.

[0020] According to some embodiments, the one or more internal passages may include a second internal passage. The at least one giver needle may be configured to pass through or within the second internal passage. According to some embodiments, the at least one giver needle may be configured to pass through the snare portion of the snare needle.

[0021] According to some embodiments, the first and second internal passages may be configured to cross or join each other.

[0022] According to some embodiments, the at least one anchoring element may include a slit configured to allow release of the suture from the first internal passage.

[0023] According to some embodiments, the closure device includes a knot formed by winding the suture around the at least one receiver needle. The closure device may be configured to deploy the knot together with the suture.

[0024] According to some embodiments, a distal tip of the distal portion of the closure device may be configured to push the knot against a wall of the blood vessel following deployment of the suture and the knot.

[0025] According to some embodiments, a second internal passage of the one or more internal passages of the at least one anchoring element may be configured to allow passage of the snare needle therethrough.

[0026] According to some embodiments, the snare portion of the at least one snare needle may be configured for passing the suture therethrough.

[0027] According to some embodiments, the snare portion of the at least one snare needle may include a pre-formed opening. The pre-formed opening may be configured to open upon deployment of the snare needle from the at least one receiver needle.

[0028] According to some embodiments, the closure device includes at least one grasper needle configured for reversible deployment from within the at least one giver needle. The grasper needle may include a grasper portion configured to hold an end of the suture. The grasper needle (at least the grasper portion thereof) may be configured for passing through the snare portion of the snare needle.

[0029] According to some embodiments, the at least one anchoring element, when in the closed state, may form part of a wall of the distal portion of the closure device.

[0030] According to some embodiments, the at least one anchoring element, when in the closed state, may form the tip of the distal portion of the closure device. According to some embodiments, the at least one anchoring element may be deployable from the distal portion of the closure device.

[0031] According to some embodiments, at least one of the proximal portion of the closure device and a body portion of the closure device may include a control handle.

[0032] According to some embodiments, the closure device may include one or more operating handles and / or operating knobs. The handles / knobs may be located at the proximal portion and / or a body portion of the closure device.

[0033] According to some embodiments, the one or more operating handles and / or operating knobs may facilitate the transition of the at least one anchoring element from the closed state to the open state and / or from the open state to the closed state.

[0034] According to some embodiments, the one or more operating handles and / or operating knobs may facilitate deployment of the at least two suturing needles from the distal portion of the closure device and / or retraction of the at least two suturing needles into the distal portion of the closure device (e.g., towards and away from the at least one anchoring element).

[0035] According to some embodiments, the one or more operating handles and / or operating knobs may facilitate the deployment of the at least one snare needle from the at least one receiver needle and / or retraction of the at least one snare needle into the at least one receiver needle.

[0036] According to some embodiments, the one or more operating handles and / or operating knobs may facilitate the deployment of the at least one grasper needle from the at least one giver needle and / or retraction of the at least one grasper needle into the at least one giver needle.

[0037] According to some embodiments, at least part of the proximal portion of the device is removable.

[0038] According to some embodiments, at least a distal end of the distal portion of the closure device is curved.

[0039] According to some embodiments, there is provided a method for deploying a suture on or around an opening in a blood vessel wall, the method includes: inserting at least part of the distal portion of a closure device as disclosed herein into the blood vessel; opening at least one anchoring element within the blood vessel; deploying at least two suturing needles from the distal portion of the closure device; deploying at least one snare needle from at least one receiver suturing needle; passing a first suture end from at least one giver needle to the at least one snare needle; retracting the at least one snare needle into the at least one receiver needle to pull the first suture end therewith; retracting the at least two suturing needles into the distal portion of the closure device; closing the at least one anchoring element; and removing the at least part of the distal portion of the closure device from the blood vessel.

[0040] According to some embodiments, the method may include passing the at least one snare needle through the at least one anchoring element.

[0041] According to some embodiments, passing a first suture end from the at least one giver needle to the at least one snare needle includes deploying the at least one grasper needle from the giver needle and passing the at least one grasper needle through the snare portion of the snare needle, with the first suture end being engaged with the grasper portion of the grasper needle.

[0042] According to some embodiments, the method may include deploying (e.g., pushing) at least one securing member on the first suture end and a second suture end.

[0043] According to some embodiments, the at least one securing member may include a pre-formed knot.

[0044] According to some embodiments, the method may include deploying a thrombogenic material (e.g., collagen) on or together with the at least one securing member. According to some embodiments, the method may include passing the first and second suture ends through a snare of a suture cutter unit.

[0045] According to some embodiments, the method may include pulling the first and second suture ends out of the suture cutter unit through a side opening of the suture cutter unit.

[0046] According to some embodiments, the method may include cutting the first and second suture ends proximally to the at least one securing member.

[0047] According to some embodiments, there is provided a suture cutter unit configured to cut suture ends following deployment of a securing member. The suture cutter unit may include a snare configured for passing the suture ends therethrough.

[0048] According to some embodiments, the suture cutter unit may include a snare handle coupled to the snare, and a side opening. Pulling of the snare handle may pull the suture ends out of the cutter unit through the side opening.

[0049] According to some embodiments, the suture cutter unit may be configured to accommodate therein and deploy therefrom a securing member configured to secure together the suture ends.

[0050] According to some embodiments, the suture cutter unit may be configured to accommodate therein and deploy therefrom a thrombogenic material (e.g., collagen).

[0051] According to some embodiments, the suture cutter unit may include a cutter configured to facilitate the cutting of the suture ends.

[0052] According to some embodiments, there is provided a kit for closing an opening in a blood vessel, the kit includes a closure device as disclosed herein and a suture cutter unit as disclosed herein.

[0053] According to some embodiments, there is provided a reverse flow device, the device includes: a reservoir configured for receiving blood from a first blood vessel; a piston configured for movement within the reservoir; a piston rod coupled to the piston, the piston rod being threaded along at least a portion of its length; and a filtering unit including an inlet port configured for coupling to the first blood vessel, an outlet port configured for coupling to a second blood vessel, and a filter configured for filtering the blood received from the first blood vessel prior to its retrieval to the second blood vessel.

[0054] According to some embodiments, a proximal end of the filtering unit includes a reservoir base configured for coupling the reservoir thereto.

[0055] According to some embodiments, the filtering unit may include an inner chamber configured for receiving therein or therethrough blood from the blood vessel. The inner chamber may be disposed between the inlet port and the reservoir base.

[0056] According to some embodiments, the filtering unit includes a first floating member disposed within the inner chamber.

[0057] According to some embodiments, the first floating member is configured to freely move within the inner chamber.

[0058] According to some embodiments, the first floating member is configured to block the inlet port of the filtering unit to prevent blood from exiting the inner chamber through the inlet port.

[0059] According to some embodiments, the filtering unit may include an air vent.

[0060] According to some embodiments, the filtering unit includes an air vent chamber comprising or connected to the air vent, and a second floating member disposed within the air vent chamber.

[0061] According to some embodiments, the second floating member is configured to freely move within the air vent chamber.

[0062] According to some embodiments, the second floating member is configured to block the air vent to prevent blood from exiting the air vent chamber through the air vent.

[0063] According to some embodiments, the reverse flow device may include one or more operational modes. The operational modes may be used independently or in combination with at least one additional operational mode.

[0064] According to some embodiments, the one or more operational modes may include an atmospheric pressure mode, in which the outlet port is closed, the air vent is open, and the piston is displaced proximally within the reservoir, thus maintaining atmospheric pressure within the reservoir. In the atmospheric pressure mode, upon opening the inlet port, blood is drawn into the reservoir due to a pressure gradient between the reservoir and the first blood vessel.

[0065] According to some embodiments, the one or more operational modes may include a passive vacuum mode, in which the outlet port is closed, the air vent is closed, the inlet port is closed, and the piston is displaced proximally within the reservoir, thus creating a vacuum within the reservoir. In the passive vacuum mode, upon opening the inlet port, blood is drawn into the reservoir due to a pressure gradient between the reservoir and the first blood vessel.

[0066] According to some embodiments, the one or more operational modes may include an active vacuum mode, in which the outlet port is closed, the air vent is closed, and the piston is displaced distally within the reservoir such that it rests against the reservoir base. In the active vacuum mode, upon opening the inlet port, blood is drawn into the reservoir by displacement of the piston proximally within the reservoir (i.e., applying suction to draw blood into the reservoir).

[0067] According to some embodiments, the one or more operational modes may include a blood retrieval mode, in which the outlet port is open, and the piston is displaced distally within the reservoir to push blood from the reservoir to the second blood vessel through the outlet port.

[0068] According to some embodiments, the one or more operational modes may include a bypass mode, in which the outlet port is open, and the piston is displaced distally within the reservoir such that it rests against the reservoir base. In the bypass mode, upon opening the inlet port, blood is transferred from the first blood vessel to the second blood vessel, through the filtering unit, due to a pressure gradient between the second blood vessel and the first blood vessel.

[0069] According to some embodiments, there is provided a two-part access sheath for providing access to a blood vessel, the access sheath includes: a proximal part which includes: a first sealing port disposed at the proximal end of the proximal part; and at least a first portion of a connector disposed at the distal end of the proximal part; and a distal part reversibly connectable to the proximal part, the distal part includes; a second sealing port disposed at the proximal end of the distal part; and at least one anchor disposed at or near the distal end of the distal part, the at least one anchor being configured for anchoring the distal part within the blood vessel.

[0070] According to some embodiments, the distal part of the access sheath includes at least a second portion of the connector disposed at or near the proximal end of the distal part and configured for engagement with the at least a first portion of the connector.

[0071] According to some embodiments, the proximal part includes a reverse flow port configured for connecting a reverse flow device thereto.

[0072] According to some embodiments, the at least one anchor includes a balloon, and the distal part includes an inflation port configured for connecting an inflation device thereto.

[0073] According to some embodiments, the at least one anchor includes an expandable structure.

[0074] According to some embodiments, at least one of the first and second sealing ports includes a hemostatic valve.

[0075] According to some embodiments, the distal part of the access sheath is configured to enable insertion of a distal portion of a closure device into the blood vessel therethrough.

[0076] According to some embodiments, the distal part of the access sheath is reversibly couplable to the distal portion of the closure device.

[0077] According to some embodiments, there is provided a system for treating a blood vessel, the system includes a closure device as disclosed herein, and one or more of: a reverse flow device as disclosed herein, a suture cutter unit as disclosed herein and an access catheter / sheath as disclosed herein. Each possibility is a separate embodiment.

[0078] According to some embodiments, the access sheath is a two-part access sheath as disclosed herein.

[0079] According to some embodiments, the system may include at least one distal expandable member (e.g. balloon) and / or distal filter (e.g., embolic filter), for positioning distally to the treated area, for example, in the internal carotid artery or in the external carotid artery.

[0080] According to some embodiments, the at least one distal expandable member and / or distal filter may be part of the two-part access sheath.

[0081] According to some embodiments, the system may include at least one guidewire.

[0082] Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more other technical advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages.

[0083] BRIEF DESCRIPTION OF THE FIGURES

[0084] Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the disclosure. For the sake of clarity, some objects depicted in the figures are not to scale.

[0085] In the figures:

[0086] Figure 1A shows a schematic view of a closure device, according to some embodiments;

[0087] Figure IB shows a schematic view of a closure device having a distal portion with a curved distal end, inserted into a blood vessel, according to some embodiments;

[0088] Figures 2A-2D show schematic views of a distal portion of a closure device, according to some embodiments;

[0089] Figures 3A-3I show schematic views of a suture deployment mechanism of a closure device, at various stages of suture deployment, according to some embodiments;

[0090] Figure 4 shows steps in operating a suturing device, using a control handle, according to some embodiments; Figures 5A-5B show steps in operating a suturing device, using a rotatable control handle, according to some embodiments;

[0091] Figure 6 shows a block diagram of a method for deploying a suture to close an opening in a blood vessel using a closure device, according to some embodiments;

[0092] Figures 7A-7D show schematic opposite side views of a distal portion of a closure device with an anchoring element being part of an external wall of the distal portion, in a closed position (Figs. 7A and 7C), and an open position (Figs. 7B and 7D), according to some embodiments;

[0093] Figures 8A-8L show schematic views of a suture deployment mechanism of a closure device, at various stages of suture deployment, according to some embodiments;

[0094] Figures 9A-9D show schematic views of a knot pushing mechanism located at a distal tip of a closure device, according to some embodiments;

[0095] Figure 10 shows a block diagram of a method for deploying a suture to close an opening in a blood vessel using a closure device, according to some embodiments;

[0096] Figures 11A-11C show schematic views of a distal portion of a closure device used for closing large bore access sites, according to some embodiments;

[0097] Figures 12A-12F show schematic views of a distal portion of a closure device having an anchoring element at a distal tip thereof, according to some embodiments;

[0098] Figures 13A-13B show schematic views of a distal end of a closure device, according to some embodiments;

[0099] Figures 14A-14D show schematic illustrations of a suture deployment mechanism during various stages of suture deployment, according to some embodiments;

[0100] Figure 15 shows a schematic illustration of an exemplary distal end of a suturing needle, according to some embodiments;

[0101] Figure 16 shows a schematic illustration of a suturing needle associated with a suture, according to some embodiments;

[0102] Figures 17A-17D show schematic illustrations of a distal region of a closure device having a pivotable anchoring element deployable from a distal end of the closure device, according to some embodiments; Figures 18A-18B show schematic illustrations of a pivotable anchoring element having two separable body portions, in a closed position (Fig. 18A), and an open position (Fig. 18B), according to some embodiments;

[0103] Figures 19A-19C show schematic illustrations of a closure device, according to some embodiments;

[0104] Figures 20A-20D show schematic illustrations of a pusher-cutter device, according to some embodiments;

[0105] Figures 21A-21F show exemplary configurations of a closing member, according to some embodiments;

[0106] Figures 22A-22B show schematic illustrations of a balloon catheter for providing access to a blood vessel, according to some embodiments;

[0107] Figure 23 shows a schematic illustration of a proximal region of a balloon catheter and a reverse flow device coupled thereto, according to some embodiments;

[0108] Figures 24A-24B show schematic illustrations of a two-part access sheath, according to some embodiments;

[0109] Figures 25A-25C show schematic illustrations of a deployable access port associated with a closure device, according to some embodiments;

[0110] Figures 26A-26C show schematic illustrations of a reverse flow device, according to some embodiments; and

[0111] Figures 27A-27C show schematic illustrations of a filtering unit of a reverse flow device, according to some embodiments.

[0112] DETAILED DESCRIPTION

[0113] The principles, uses, and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout.

[0114] According to some embodiments, there is provided herein an advantageous closure device of a blood vessel, in particular, but not limited to, the carotid artery, which allows a safe, efficient, reliable and cost effective suturing / closure of an opening in the carotid artery following carotid artery treatment.

[0115] As used herein, the term “blood vessel” refers to any of the five types of blood vessels: the arteries, which carry the blood away from the heart; the arterioles; the capillaries, where the exchange of water and chemicals between the blood and the tissues occurs; the venules; and the veins, which carry blood from the capillaries back towards the heart. In some embodiments, a blood vessel is a carotid artery. In some embodiments, a blood vessel is a femoral artery. In some embodiments, a blood vessel is a femoral vein.

[0116] Reference is now made to Fig- 1A, which shows a schematic view of a closure device, according to some embodiments. As shown in Fig. 1A, closure device 100 includes a distal portion 120, the distal end of which is configured to be inserted into a blood vessel and facilitate closing of an opening in the vessel, using a suture deployment mechanism, as detailed hereinbelow. Closure device 100 further includes a central (body) portion 130 configured to house one or more lumens, needles, sutures, driving mechanisms configured to operate or control the operation of the suture deployment mechanism, etc. Closure device 100 further includes a proximal portion 140, which may include at least one handle configured to allow holding and / or operating the device by a user. The closure device may include on or in the body thereof or any of its one or more handles, one or more operating buttons or knobs (such as knob 132), which are configured to control and / or adjust movement, relative position and / or location of one or more elements in the distal portion of the closure device, as further detailed herein below. In some embodiments, the body portion 130 and proximal portion 140 together are formed as a single portion. The body portion 130 and proximal portion 140 together may be referred to herein as a “control handle” of the closure device 100. According to some embodiments, the distal portion 120 of the closure device, or at least the distal end or distal tip thereof, may acquire any desired shape (such as, straight, angled, curved, bended, deviated, etc.), that may be preshaped, or adjusted during use. Fig. IB shows a schematic view of a closure device having a curved distal end, according to some embodiments. Closure device 150 includes a distal portion 180, having a distal end 182, which is curved. Part of the distal portion is shown after having been inserted into a blood vessel 190. Further shown is the central (body) portion 160 of the device, which is configured to house one or more lumens, needles, sutures, driving mechanisms configured to operate or control the operation of the suture deployment mechanism, and the like. Also shown is proximal portion 170, configured to allow holding and / or operating the device by a user (e.g., physician). In some embodiments, the body portion 160 and proximal portion 170 together are formed as a single portion. The body portion 160 and proximal portion 170 together may be referred to herein as a “control handle” of the closure device 150.

[0117] Reference is now made to Figs. 2A-2D, which show schematic views of a distal portion of a closure device, according to some embodiments. Fig. 2A shows a perspective view of a distal portion 200 of a closure device, shown in the form of an elongated body and including a distal tip 202, wherein the distal end of the distal portion, including the distal tip, are configured to be inserted into a blood vessel (not shown). Further shown is opening 204A in the body of the distal portion 200, which is configured to allow (together with corresponding opposing opening 204B, shown in Fig. 2C) deployment / opening of an anchoring element 210 (shown in a closed state in Fig. 2A). At least one pin / hinge (not shown in Figs. 2A-2D) of the anchoring element 210 is moveable along slot / groove 208A (and, in certain embodiments, along a corresponding opposing slot / groove 208B, shown in Figs. 2C-2D), such that hinged movement of the anchoring element 210 results in opening / closing thereof, as further detailed below herein. Also shown is opening 206A (opposing opening 206B is shown in Fig. 2C), through which a suturing needle is deployed. Openings 206A-206B may be positioned essentially on opposite sides of the body of the closure device. In some embodiments, a first opening 206A is positioned distally to a second opening 206B, as shown in Fig. 2C below. Fig. 2B shows a perspective view of distal portion 200, with anchoring element 210 in an open position, after deployment (e.g., by being rotated / pi voted) to protrude through opening 204A (and a corresponding opening on the opposing side). Fig. 2C shows a side view of the distal portion 200 of the closure device with anchoring element 210 in an open position, after being rotated (e.g., by at least one pin moving along slot(s) 208A-208B), to protrude from openings 204A-204B. Also shown are openings 206A-206B, positioned on opposite sides of the elongated body of the distal portion of the closure device, with opening 206A being positioned distally relative to opening 206B. It can be appreciated, that in other embodiments, opening 206A may be positioned proximally relative to opening 206B, or the two openings may be positionally aligned along the length of the closure device’s distal portion. Additionally shown in Fig. 2C is a positioning indicator opening 212, which is configured to provide indication to the user as to the positioning of the distal portion 200 within the blood vessel. Opening 212 allows entry of blood into the distal portion 200 of the closure device (through the opening) when the opening 212 is located within the blood vessel. The blood that enters the distal portion of the closure device then emerges out from a portion of the closure device which is located externally to the patient’s body (e.g., the proximal end of the proximal portion), indicating to the user that the opening 212 is within the blood vessel, and thus that the distal portion 200 is deeper within the blood vessel than the location of the opening. In some embodiments, the user then controllably retracts the closure device proximally (e.g., pulls) until blood no longer emerges from the proximal end of the closure device, indicating that the opening 212 is out of the blood vessel. According to some embodiments, as detailed hereinbelow, after blood has stopped leaking from the proximal portion of the closure device, the anchoring element 210 is opened. The device, or at least the distal portion thereof, may then be slightly proximally retracted (for example, manually by a user), to have the open anchoring element 210 establish contact with an inner wall of the blood vessel, such that the distal end of the device is anchored / secured within the blood vessel. Fig. 2D shows a side view of the distal portion 200 of the closure device after two suturing needles 216A- 216B have been deployed from lumens (not shown) within the distal portion 200. Suturing needles 216A-216B each protrude from its respective opening 206A-206B, such that the distal tip of each of suturing needles 216A-216B, is in close proximity, engages, passes through or positioned within the respective ends (or cavities or openings) of the open anchoring element 210. The engagement with the anchoring element occurs simultaneously with or after the distal tips of the needles penetrate the wall of the blood vessel. As further detailed herein below, the needles are at least partially hollow (e.g., include a lumen), allowing the passage of a suture (thread) or other needles, wires or tools, therethrough.

[0118] According to some embodiments, the distal portion (and / or its end or tip) of the closure device may have any desired shape, including round, edged, straight, and the like, allowing the placement and / or movement of the tip within the blood vessel, but essentially without puncturing or otherwise harming the blood vessel walls. In some embodiments, the distal portion 200 and / or the distal tip 202 thereof may be made of any suitable materials, including, for example, but not limited to, metallic material, polymeric material, plastic, hardened rubber, and the like, or any combinations thereof According to some embodiments, the distal portion of the closure device may be assembled as a single component and be attached to or associated with the body and / or the control handle of the device. In some embodiments, the association or the attachment may be reversible. In other embodiments, the association or the attachment may be permanent. In some embodiments, the distal portion of the device may be integrally formed with one or more other portions of the closure device.

[0119] According to some embodiments, the distal portion of the closure device may be rigid, semiflexible or flexible. In some embodiments, the distal portion is preshaped. In some embodiments, the shape of the distal portion may be adjusted. In some embodiments, the distal portion is straight. In some embodiments, the distal portion and / or the end or tip thereof is curved or angled (relative to the longitudinal axis of the body of the device).

[0120] According to some embodiments, the anchoring element may be made of, or may include, metallic material (such as stainless steel), polymeric material, plastic, hardened rubber, or any combinations thereof.

[0121] According to some embodiments, the closure devices disclosed herein enable the insertion of the distal portion thereof (or at least its distal end or tip) into the blood vessel, thereafter the anchoring element may be deployed / opened to secure the device to its position, such that the distal portion is within the blood vessel, at least in part. After which, the suturing needles may be deployed, simultaneously or sequentially, to facilitate the passage of a suture from a first needle, via passage(s) in the body of the anchoring element, to a second needle, to facilitate the deployment of at least one suture on at least two sides of the opening in the blood vessel, and consequently, the closure thereof. In some embodiments, the deployment of the anchoring element provides counter force against the inner wall of the blood vessel, as the needles penetrate the wall.

[0122] Reference is now made to Figs. 3A-3I, which show a suture deployment mechanism of a closure device, at various stages of suture deployment / placement, according to some embodiments.

[0123] Shown in Fig. 3A is a close up view of a suturing mechanism 350, which is located in distal portion 300 of a closure device. In some embodiments, suture deployment mechanism 350 includes at least two suturing needles 316A-316B, and at least one anchoring element 310. In Fig. 3A, the anchoring element 310 is in its open state, and the suturing needles 316A-316B are deployed. In some embodiments, the suturing needles include a first suturing needle 316A and a second suturing needle 316B, which as detailed above, are configured to be deployed from the body of the closure device, through their respective openings in the distal portion 300 of the device, and into the blood vessel. As detailed above, the needles are at least partially hollow (e.g., include a lumen), allowing the passage of a suture (thread) from the first suture needle to the second suture needle, or vice versa. In some embodiments, a suture end may be initially associated with the first needle (also referred to herein as “giver suturing needle” or “giver needle”) and then passed to the second needle (also referred to herein as “receiver suturing needle” or “receiver needle”). In some embodiments, the suture deployment mechanism further includes a snare needle 322, which is configured to be deployed from the receiver suturing needle 316B, and accept the suture end passed from the giver suturing needle 316A. The passage of the suture is also facilitated, inter alia, via one or more passages in the body of anchoring element 310, as further detailed hereinbelow. As detailed hereinabove, anchoring element 310 is configured to be deployed / opened within the blood vessel, to facilitate anchoring of the device (in particular, the distal portion thereof), within the blood vessel, and passing of the suture from the first suturing needle to the second suturing needle. Further shown in Fig. 3A is indicator opening 312, which, as detailed above, is used to provide indication of the positioning of the distal portion of the device within the blood vessel. In some embodiments, the opening of anchoring element 310 may be facilitated via movement of a pin / hinge 324 along at least one slot 308, to thereby allow the pivoting of the anchoring element and its transition from a closed position to an open position. In some embodiments, when in the open state, the anchoring element is positioned at an angle relative to the longitudinal axis of the distal portion of the closure device, as shown, for example, in Fig. 3 A.

[0124] Fig. 3B shows a partial transparent view of the suturing deployment mechanism 350, showing an internal passage 314 formed in the anchoring element 310 for passing a suture therethrough. Also shown are deployed suturing needles 316A-316B (prior to deployment of the snare needle from the suturing needle 316B).

[0125] Fig. 3C shows a partial cross-sectional perspective view of the suture deployment mechanism, showing snare needle 322 deployed out of the receiver needle 316B. As detailed herein, snare needle 322 may include any type of fixture or structure to allow the gripping or holding of the suture (e.g., a free end of the suture). In some embodiments, the snare needle 322 includes a snare portion 323 at or near the distal tip or distal end thereof, to facilitate gripping or holding of the suture. The snare portion 323 may include a loop or lasso structure, as shown in Fig. 3C.

[0126] According to some embodiments, the snare needle may include one or more structures or fixtures at or near the distal region or at the distal tip thereof, facilitating the holding or gripping of a free end of the suture. In some embodiments, the structure(s) may include a slot or a cut in the body of the snare needle, which can expand or open as the snare needle protrudes from the receiving suturing needle (e.g., forming a loop), to allow gripping of the suture therewith. Thereafter, the slot or formed loop may optionally narrow as the snare needle is being pulled into the suturing needle, thereby securing the gripping of the suture by the snare needle. The snare needle may be made of nitinol, and the snare portion may include a laser-cut slot biased to open to a loop (lasso) when not subjected to external forces (such as those applied by the lumen of the receiver needle when housed therein). In some embodiments, the closure device may include a mechanism for opening and / or closing the snare portion of the snare needle, which can be activated by the user, e.g., via the control handle. In some embodiments, the structure may include one or more perforations or openings in the walls of the snare needle, allowing association and gripping of the suture and the consequent pulling thereof, when entering into the suturing needle. In some embodiments, the snare portion may be made of or include any suitable biocompatible materials, such as, for example, but not limited to, metal (e.g., nitinol), plastic, fiber, and the like, or any combinations thereof.

[0127] Fig. 3D shows a partial transparent view of anchoring element 310, showing the passage (channel) 314 formed in the body of anchoring element 310 and allows / directs the passage of the suture 328, within the anchoring element, from the giver suturing needle 316A towards the receiver suturing needle 316B. Passage 314 is positioned such that it is continuous from the distal tip 326A of giver suturing needle 316A to the snare portion 323 of the snare needle 322 when deployed from receiver suturing needle 316B. After the anchoring element 310 has been opened within the blood vessel and the suturing needles have been deployed to puncture the walls of the blood vessel (by virtue of their pointed or otherwise penetrating tips 326A-326B), the tips of the needles may reside within their corresponding pockets within the body of the anchoring element, or in close proximity thereto. Once the needles are positioned, the suture 328 may be advanced from the giver needle 316A to passage 314. The suture may advance through the lumen of the giver suturing needle 316A to protrude from the distal tip of the needle, or it may be otherwise associated with the giver needle 316A and released therefrom to enter the passage 314. In some embodiments, the suture is advanced from the proximal end of the closure device, or from a depot (for example, in the form of a cartridge) in the body of the closure device, via a corresponding advancement mechanism, as detailed below. In some embodiments, there is provided a support needle 317, which is an inner needle deployed from the giver needle 316A, facilitating the threading of the suture through the giver needle and / or the holding of the suture therewithin. The suture may be coupled thereto, at the proximal end, at the distal end and / or along its length. The suture 328 further advances via passage 314, to protrude from the opposing opening of the passage, in the region of receiver needle 316B, for example, until the free end of the suture is threaded through the open snare portion 323 of the snare needle 322. According to some embodiments, the suturing device may include (for example, in the handle / body thereof), a mechanism for holding and releasing the suture. In some embodiments, such mechanism may be, for example, but not limited to, spring-based or friction-based (for example, using silicone). In some embodiments, the giver needle may include slit(s) (for example, lasercut slits), that can function as one-way valve(s) along its length, allowing the releasing of the suture.

[0128] Fig. 3E shows a close-up cross-sectional perspective view of the suture 328 being threaded through the snare portion 323 of the snare needle 322.

[0129] In some embodiments, the receiver needle itself includes a snare portion, facilitating the threading and gripping of the suture or otherwise associating with the suture. In such embodiments, a separate snare needle may be unnecessary.

[0130] As shown in Fig. 3F, after the snare portion 323 has associated with the suture 328 (for example, by gripping the suture, passing the suture through the snare portion, closing the snare portion on the suture, etc.), the snare needle, with the suture, is retracted into the lumen of receiver suturing needle 316B.

[0131] Shown in Fig. 3G is the suture 328 disposed between the giver suturing needle 316A and the receiver suturing needle 316B, through channel 314, after retraction of the snare needle into the receiver suturing needle 316B. As shown in Fig- 3H, the suturing needles have been fully retraced, leaving threaded suture 328 deployed within the blood vessel (not shown). Anchoring element 310 is still in an open position.

[0132] As shown in Fig. 31, after the suture 328 has been passed from the giver suturing needle (not shown in Fig. 31) to the receiver suturing needle (not shown in Fig. 31), through anchoring element 310, and after the suturing needles have been retracted, the suture is released from the anchoring element by pulling of the needles and / or by closing of the anchoring element. The anchoring element is then closed, e.g., pivots back (for example, by movement of hinge 324 within opening 308) to a closed position (i.e., being housed within the distal portion of the closure device, and being essentially parallel to the longitudinal axis thereof). Thus, the suture can be pulled to tighten on the blood vessel, and close / seal the puncture, after or during the removal of the distal portion of the closure device from the blood vessel. In some embodiments, after or during placement of the suture on or around the puncture in the blood vessel, a knot, or any other suitable securing member, is formed and / or placed over the suture ends, adjacent the wall of the blood vessel (internally and / or externally), to secure the closing of the puncture in the blood vessel, as described in detail hereinbelow.

[0133] According to some embodiments, the movement (for example, deployment, rotation, pivoting, retraction, pulling, pushing, etc.) of any one of elements of the suture deployment mechanism, such as the suturing needles, the snare needle, the anchoring element and / or the suture may be controlled via the control handle of the closure device. In some embodiments, the proximal portion of the closure device serves as the control handle. In some embodiments, the proximal and central (body) portions of the closure device serve as the control handle. In some embodiments, the control is manual. In some embodiments, the control is semi-automatic. In some embodiments, the control is automatic. In some embodiments, the control is facilitated via one or more operating buttons or knobs. In some embodiments, one or more moveable carts (carriages) in the body of the closure device are utilized in order to control the movement of one or more of the above mentioned elements. For example, the movement (deployment, retraction) of the suturing needles may be facilitated by a needle carriage, which is configured to move along a longitudinal axis, in a proximal -distal direction, thereby pushing (deploying) or pulling (retracting) the needles. The operation of the carriage may be performed, for example, by a rotatable knob, pushable or displaceable button or handle, and the like. Similarly, for example, the movement (deployment, retraction) of the snare needle may be facilitated by a snare needle carriage, which is configured to move along a longitudinal axis (e.g., along a track), in a proximal-distal direction, thereby pushing (deploying) or pulling (retracting) the snare needle. The operation of the carriage may be performed, for example, by a rotatable knob, pushable button, displaceable button or handle and the like. In some embodiments, the carriage may be directly connected to the needle. In some embodiments, the carriage may be connected to the needle via an intermediate element, such as a wire or a rod. In some embodiments, the pivotal movement (open / close) of the anchoring element may be facilitated via pushing or pulling the anchoring element, which is hinged onto a dedicated slot in distal end of the closure device by means of a dedicated pin. The pushing / pulling may be facilitated via an operating button, displaceable handle, rotatable knob, and the like, which is connected to the anchoring element by any suitable means, such as, for example, wire, rod, and the like.

[0134] Reference is now made to Fig. 4, which shows steps in operating a closure device, using a control handle, according to some embodiments. Fig. 4 shows procedural steps as carried out by a user using the handle(s) and / or knob(s) of a suturing device. According to some embodiments, the operation may be manual (for example, by pressing / clicking per each step or sub-step). In some embodiments, the operation may be automated or semi-automated, whereby, using an automated handle, at least some of the suture deployment steps are carried out continuously and sequentially, with a single pressing, clicking or actuating of the handle. As shown in Fig. 4, in step 402, turning a rotating knob 420 (e.g., clockwise) opens the anchoring element (as shown, for example, in Figs. 2B-2C, and detailed above herein). In some embodiments, pressing of a button may initiate the rotation of the foot (anchoring element). In step 404, pushing down a handle 430 results in several consecutive actions: 1) The suturing needles are deployed, simultaneously or sequentially, from their respective openings in the body of the closure device (as shown, for example, in Figs. 2D and 3B); 2) The snare needle is deployed out of the receiver needle (as shown, for example, in Figs. 3 A and 3C); 3) The suture is pushed from the giver needle to the receiver needle (more specifically, to the snare needle) (as shown, for example, in Figs. 3D-3E); 4) The snare needle (with the threaded suture) is retracted into the receiver needle (as shown, for example, in Figs. 3F-3G). In step 406, pulling up the handle 430 results in retraction of the suturing needles into the closure device (as shown, for example, in Fig. 3H), and further pulling of the handle out of the closure device body 440 pulls out with it the needles with the suture ends (not shown). In some embodiments, pulling the handle may also cause the suture to be released from the anchoring element. In step 408, turning the rotating knob (e.g., counter-clockwise) closes the anchoring element (as shown, for example, in Fig. 31). Step 410 shows the end state of the closure device body 440, after the suture has been successfully deployed. The closure device is then removed from the blood vessel (e.g., carotid or femoral artery) and the body entirely, leaving the suture around the opening and the suture ends outside the body.

[0135] According to some embodiments, optionally, pushing and / or pulling the handle also opens and / or closes the anchoring element (e.g., instead of the rotating knob).

[0136] According to some embodiments, the device may include a safety (locking) mechanism (not shown), for example, to prevent pushing down the handle and deploying the needles before the foot has been opened (for example, if the foot is opened by the operation of a separate rotating knob). In some embodiments, the safety mechanism may include pressing / pulling / rotating a locking button prior to or together with pushing down the handle. In some embodiments, the safety mechanism may be implemented in the rotating knob 420, such that the handle 430 cannot be pressed down until the knob is rotated, whereby rotating the knob releases the locking of the handle. In some embodiments, there may be a need to press / pull / rotate a locking button to allow the user to continue pushing down the handle after the foot is opened, to make sure the user positions the foot properly against the inner wall of the blood vessel, before continuing the process.

[0137] Reference is now made to Figures 5A-5B, which show a closure device having a rotatable control handle, and steps of using the same, according to some embodiments. Fig. 5A shows procedural steps as carried out by a user using a rotatable handle of a closure device 500. According to some embodiments, the operation may be manual, requiring the user to rotate the rotatable handle separately to execute each step of the procedure. In some embodiments, the operation may be automated or semi-automated. In some embodiments, actuating the rotating handle once (e.g., a full rotation or a partial rotation) in one direction results in the execution of most or all of the deployment steps in a sequence. In some embodiments, actuating the rotating handle once (e.g., a full rotation or a partial rotation) in the opposite direction results in the execution of most or all of the retraction steps in a sequence.

[0138] As shown in Fig. 5A, in step 502, rotating the rotatable handle 520 (e.g., counterclockwise) may result in several consecutive actions: 1) The anchoring element is opened (as shown, for example, in Figs. 2B-2C, and detailed above herein); 2) The suturing needles are deployed, simultaneously or sequentially, from the body of the closure device through their respective openings (as shown, for example, in Figs. 2D and 3B); 3) The snare needle is deployed out of the receiver needle (as shown, for example, in Figs. 3A and 3C); 4) The suture is pushed from the giver needle to the receiver needle (more specifically, to the snare needle) (as shown, for example, in Figs. 3D-3E); 5) The snare needle (with suture) is retracted into the receiver needle (as shown, for example, in Figs. 3F-3G). In step 504, pulling a gripper handle 530 results in retraction of the suturing needles into the closure device (as shown, for example, in Fig. 3H) and, optionally, further pulling of the gripper handle 530 out of the closure device body 540, pulls out with it the needles with the gripped suture ends (not shown). In some embodiments, pulling the gripping handle 530 may also cause the suture to be released from the anchoring element. In step 506, rotating the rotatable handle 520 closes the anchoring element (as shown, for example, in Fig. 31). In some embodiments, the direction of rotation to close the anchoring element may be the same as the direction of rotation to open the anchoring element (step 502), e.g., counter-clockwise. In some embodiments, the direction of rotation to close the anchoring element may be opposite from the direction of rotation to open the anchoring element (step 502), e.g., clockwise. Step 508 shows the end state of the closure device body 540, after the suture has been successfully deployed. The closure device is then removed from the artery and the body entirely, leaving the suture around the opening and the suture ends outside the body. According to some embodiments, the device may include a safety mechanism. For example, a locking pin (or button) 550 is to be pressed and / or pulled and / or rotated to allow rotation of the handle 520. For example, the handle may re-lock after the foot is opened, to make sure the user positions the foot properly against the inner wall of the artery before continuing the process. The user may then be required to press / pull / rotate the locking pin 550 to release the handle 520 and enable its continued rotation for the execution of the next steps in the suture deployment process. Fig. 5B shows a longitudinal cross-sectional view of a closure device 580 having a rotatable control handle 585, according to some embodiments. Shown in Fig. 5B is the driving mechanism of the suture deployment mechanism, which may include, in some embodiments, an anchoring element carriage 582, a suturing needle carriage 584, a snare needle carriage 586 and a suture carriage 588. The driving mechanism may include additional elements, such as springs, latches, etc.

[0139] Reference is now made to Fig. 6, which shows a block diagram of a method for deploying a suture on or around an opening in a blood vessel and / or closure thereof, using a closure device, according to some embodiments. In some embodiments, the suture deployment method is carried out prior to the medical procedure (e.g., placement of a stent), and once the medical procedure is completed, the opening in the blood vessel is closed using the previously placed suture. In some embodiments, the medical procedure is carried out first, and once the medical procedure is completed, the suture deployment method is carried out, and the opening in the blood vessel is closed using the deployed suture immediately thereafter.

[0140] As shown in Fig. 6, method 600 includes at step 602, insertion of the distal portion of a closure device (or at least the distal end thereof), as disclosed herein, into a target blood vessel through an opening or puncture. In some embodiments, the closure device may create the opening or puncture in the blood vessel. After it has been verified that the distal end is positioned as desired within the blood vessel (e.g., using an indicator opening or a port in an access sheath, as described herein), an anchoring element is deployed within the blood vessel, at step 604. At step 606, suturing needles (e.g., two needles, four needles) are deployed from their respective openings in the distal end of the closure device, to enter the blood vessel through the wall of the blood vessel, such that the tips of the needles are positioned in close proximity to the anchoring element or within dedicated cavities within the anchoring element. In some embodiments, the suturing needles are deployed simultaneously. In some embodiments, the suturing needles are deployed sequentially. At step 608, a snare needle is deployed from one of the suturing needles (e.g., a receiver needle), to engage (e.g., grip, receive) a free end of the suture, whereby at step 610, a suture is passed from a first (giver) needle to the second (receiver needle). In some embodiments, the suture is passed via a passage in the body of the anchoring element towards the distal end of the second (receiver) needle, e.g., to pass through a snare portion of the snare needle protruding from the distal end of the receiver needle. Next, at step 612, the snare needle is retracted into the receiver needle, while pulling the suture therewith. At step 614, after the suture has been passed between the suturing needles, the suturing needles are retracted, either simultaneously or sequentially. The suture needles may be retracted into the distal portion of the closure device first and then pulled out (e.g., manually) from the closure device, so as to exit entirely from the patient’s body. In some embodiments, the suturing needles are retracted into the closure device and remain therein until the closure device is removed, with the suturing needles therein, from the patient’s body. At step 616, the anchoring element is retracted (e.g., pivoted to its closed state). In some embodiments, the suture is released from the anchoring element as the needles are retracted or pulled out of the closure device. In some embodiments, the suture is released from the anchoring element during closing of the anchoring element. At step 618, the closure device is removed from the blood vessel (and the patient’s body entirely), leaving the threaded suture on or around the puncture site in the blood vessel. It is noted that method 600 may include some or all of the described steps and that the method steps may be carried out in a different order.

[0141] Reference is now made to Figs. 7A-7D, which show schematic opposite side views of a distal portion of a closure device, with an anchoring element being part of an external wall of the distal portion, in a closed position (Figs. 7A and 7C), and an open position (Figs. 7B and 7D), according to some embodiments. As shown in Figs.7A-7B, distal portion 700 of a closure device includes an anchoring element 710, which is part of the wall of the distal portion. Anchoring element 710 is shown in a closed position in Fig. 7A and in an open position in Fig. 7B. The opening of anchoring element 710 may be facilitated via movement of a pin / hinge 712 of the anchoring element along a groove 720, to thereby allow the pivoting of the anchoring element and its transition to the open position. Shown in Figs. 7C-7D is an opposite side view of Figs 7A-7B, showing groove 720, which allows the opening via pivoting of the anchoring element 710. As shown in Figs. 7C-7D, the groove 720 may have a wavy form (rather than a straight groove). In some embodiments, such a wavy form enables a continuous / smooth outer surface wall, while not interrupting the pivoting movement of the anchoring element 710. As the pin 712 moves along the groove 720, the groove’ s wavy form distances the anchoring element 710 from the side wall of the device’s distal portion, such that the edge of the anchoring element does not touch the side wall of the distal portion as it pivots. Reference is now made to Figs. 8A-8L, which show a suture deployment mechanism of a closure device, at various stages of suture deployment, according to some embodiments. The closure device shown in Figs. 8A-8L includes an anchoring element which is part of an external wall of the distal portion of the closure device.

[0142] Shown in Fig. 8A is a distal portion 800 of the closure device inserted into a blood vessel. In some embodiments, the suture deployment mechanism 850 includes an anchoring element (foot) 810. The anchoring element (foot) 810 is shown in Fig. 8A in its open position, such that it is adjacent and substantially parallel to an inner wall 5 of the blood vessel. In some embodiments, the opening of anchoring element 810 may be facilitated via movement of a pin (not shown) of anchoring element 810 along at least one groove 808 formed in an opposite wall of the distal portion 800, to thereby allow the pivoting of the anchoring element and its transition to an open position.

[0143] In some embodiments, the suture deployment mechanism 850 includes at least two suturing needles, such as a giver suturing needle and a receiver suturing needle. As detailed hereinabove, the suturing needles are configured to be deployed from the body of the closure device through their respective openings in the distal portion 800 of the device. Shown in Fig. 8B is a receiver suturing needle 816A deployed from the body of the closure device and into the blood vessel. In some embodiments, once deployed, the tip 826A of the receiver suturing needle 816A is positioned within a dedicated cavity 812 in the anchoring element 810. In some embodiments, cavity 812 forms, or is positioned at, a first end of an internal passage (not shown in Fig. 8B) running through the length (or at least a portion thereof) of the anchoring element 810. In some embodiments, the closure device may hold and be used for deploying a pre-formed knot on the suture ends as part of the suture deployment process. As shown in Fig. 8B, for example, a knot 830 may be formed by winding the suture several times around the receiver suturing needle 816A.

[0144] As shown in Figs. 8C-8D, the suture deployment mechanism 850 includes a snare needle 822 reversibly deployable from the lumen of the receiver needle 816A. In some embodiments, as shown in Figs. 8C-8D, the snare needle 822 is passed from the receiver suturing needle 816A, through a channel 814 formed in the anchoring element 810, to receive or otherwise engage with the suture end associated with the giver suturing needle. The snare needle 822 may include at or near its distal tip or distal end a snare portion 823, which may be in the form of a loop (lasso) structure, a slot, an opening, or the like, as described in further detail hereinabove. In some embodiments, the snare portion 823 of the snare needle 822 is designed to open upon exiting the receiver needle 816A and / or the internal channel 814 (i.e., when substantially no restricting forces are present). It can be appreciated that in Fig. 8D the anchoring element is shown without a (front) portion thereof, to allow viewing of the internal channel 814 and the passing of the snare needle 822 therethrough.

[0145] Shown in Fig. 8E is a giver suturing needle 816B deployed from the body of the closure device and into the blood vessel. In some embodiments, once deployed, the tip 826B of the giver suturing needle 816B is positioned within a dedicated cavity in the anchoring element 810, in a similar manner as the tip of the receiver suturing needle. In some embodiments, the anchoring element 810 has a second inner passage (shown in Figs. 8D and 8H) which traverses the anchoring element 810 from its upper surface to its bottom surface or side surface, such that it conjoins, or crosses, the longitudinal inner channel of the anchoring element 810. In some embodiments, the longitudinal channel and the transverse passage are substantially perpendicular to each other. In some embodiments, the longitudinal channel and the transverse passage are conjoined, or cross each other, at an angle. In some embodiments, as shown in Fig. 8E, once deployed, the giver suturing needle 816B passes through the transverse passage and through (or otherwise in association with) the snare portion 823 of the deployed snare needle, such that the tip 826B of the giver needle 816B extends beyond the snare portion 823 of the snare needle. Further shown in Fig. 8E is the suture 828 which runs along the length (or at least a portion thereof) of the giver needle 816B, with an end (not shown in Fig. 8E) of the suture 828 positioned within the giver needle 816B.

[0146] Shown in Fig. 8F is a grasper needle 827 deployed from the giver suturing needle 816B, such that a grasper portion 829 of the grasper needle 827 extends beyond the tip 826B of the giver needle 816B. In some embodiments, the grasper portion 829 of the grasper needle 827 is configured to hold and release the end of the suture 828 positioned initially within the giver needle 816B. The grasper portion 829 may include two or more arms which are held together while constrained within the lumen of the giver needle 816B, to grip the end of the suture 828. Once the grasper portion 829 exits the tip 826B of the giver needle 816B, the grasper portion’ s arms move away from each other, resulting in the suture’s end being released therefrom. In some embodiments, the grasper portion may include a single arm which holds (presses) the suture against the lumen of the giver needle (i.e., an inner wall thereof) while being constrained within the lumen. Once the grasper portion exits the giver needle’s lumen, its hold of the suture is released. In some embodiments, the grasper portion 829 of the grasper needle 827 may have a substantially similar design to that of the snare portion of the snare needle, i.e., it may have a loop (lasso) structure, a slot, an opening, or the like. The grasper needle 827 may be made of nitinol, and the grasper portion 829 may include a laser-cut slot biased to open to a loop (lasso) when and it is no longer subjected to external forces, such as those applied by the lumen of the giver needle 816B. In some embodiments, the closure device may include a mechanism for opening and / or closing the grasper portion 829 of the grasper needle 827. In some embodiments, the grasper needle 827 may be made of or include any suitable biocompatible materials, such as, for example, but not limited to, metal (e.g., nitinol), plastic, fiber, and the like, or any combinations thereof.

[0147] Shown in Figs. 8G-8H is the suture 828 threaded through the snare portion 823 of the snare needle, after retraction of the grasper needle and the giver suturing needle. As shown, a suture end 8282 extends beyond the snare portion 823 after having been released from the grasper portion of the grasper needle. In some embodiments, the grasper needle is first retracted into the lumen of the giver suturing needle, and the giver suturing needle is then retracted into the body of the distal portion 800 of the closure device through its deployment (and retraction) opening 802B. In some embodiments, the grasper needle and the giver needle are retracted in an alternate manner. For example, the giver needle may be partially retracted first, then the grasper needle is retracted into the giver needle’s lumen, and only then the giver needle is retracted into the body of the distal portion 800 of the closure device. Such alternate retraction may prevent or at least minimize the risk of the grasper portion of the grasper needle inadvertently re-gripping the suture as it is being retracted into the giver needle and forcibly closed.

[0148] Fig. 81 shows the suture 828 extending between the deployment opening 802B of the giver needle and the receiver needle 816A, through the inner (longitudinal) passage (not shown in Fig. 81) of the anchoring element 810, after retraction of the snare needle into the receiver needle 816A. In some embodiments, the snare needle is retracted into the lumen of the receiver suturing needle 816A and remains therewithin until a later stage of the suture deployment process. In some embodiments, after retraction of the snare needle into the lumen of the receiver suturing needle 816A, the snare needle is further retracted proximally through the lumen of the receiver suturing needle 816A, until it is removed out of the closure device entirely, pulling with it out of the patient’s body the suture end which was initially housed within the giver suturing needle. In some embodiments, retraction of the snare needle, in one or more steps, is carried out automatically, e.g., by actuation of a mechanical mechanism within the closure device using the device’s control handle. In some embodiments, retraction of the snare needle into the lumen of the receiver suturing needle 816A is carried out automatically, whereas retraction of the snare needle out of the lumen of the receiver suturing needle 816A and the closure device entirely is done manually by the user, e.g., by the physician gripping a knob coupled to the snare needle and pulling it proximally, as described hereinbelow.

[0149] Fig. 8J shows the suture 828 threaded between the deployment (and retraction) opening 802B of the giver needle and the deployment (and retraction) opening 802A of the receiver needle, through the inner longitudinal passage (not shown in Fig. 81) of the anchoring element 810, after retraction of the receiver suturing needle into the body of the distal portion 800 of the closure device. It can be seen that retraction of the receiver needle leaves the knot 830 in place, such that the suture 828 is threaded through the knot 830. In some embodiments, the suture 828 can be removed from the anchoring element 810 via a slit 815 formed in the anchoring element 810. Slit 815 connects the inner longitudinal channel of the anchoring element 810 with the environment external to the anchoring element 810, which in Fig. 8J is the lumen of the blood vessel. Removal of the suture 828 from the anchoring element 810 through slit 815 can be done by pulling of the suture ends and / or via closing of the anchoring element 810.

[0150] Shown in Fig. 8K is the suture 828 threaded between the deployment (and retraction) opening 802B of the giver needle and the deployment (and retraction) opening 802A of the receiver needle, after being released from the inner channel of the anchoring element 810, via slit 815, and closing of the anchoring element 810.

[0151] According to some embodiments, after the suture is placed around the opening in the wall of the blood vessel, with the knot 830 thereon, the knot 830 is tightened against the vessel wall, to ensure that the opening in the blood vessel wall is properly closed. In some embodiments, the knot 830 may be pushed against the blood vessel using the distal tip of the closure device. In such embodiments, as shown in Fig. 8L, after the distal portion 800 of the closure device is removed from the patient’s body, it is reinserted into the patient’s body over the portion 8285 of the suture which has been threaded through the knot 830. The threaded portion 8285 of the suture may be received within the distal tip 805 of the distal portion 800, as described hereinbelow. The distal tip 805 may then be moved along the length of the suture portion 8285, pushing the knot 830 toward the blood vessel’s wall, while the second portion of the suture is securely held externally to the patient’s body. In other embodiments, the knot 830 may be tightened / pushed against the blood vessel using a separate device, such as a suture cutter unit, as described in detail hereinbelow.

[0152] Reference is now made to Figs. 9A-9D, which show a distal tip of a closure device which is used to push and / or tighten a suture knot against a wall of the blood vessel following suture deployment, according to some embodiments.

[0153] Shown in Fig. 9A is a distal tip 905 of a distal portion 900 of a closure device, for example, the closure device of Figs. 8A-8L. In some embodiments, a grove 9052 is formed in the distal tip 905, to receive a suture therein. The groove 9052 may have at least one slanted surface, e.g., be V-shaped, as shown in Fig. 9A, to facilitate insertion of the suture into the groove.

[0154] Shown in Fig. 9B is the distal tip 905 of the distal portion 900 of the closure device. In some embodiments, the groove 9052 may terminate in a dedicated slot 9054 shaped to receive therein a portion of the suture. In some embodiments, the groove 9052 may further include a locking mechanism 9056 configured to ensure that the suture portion remains within the groove 9052 (specifically, within slot 9054) once received therein. In some embodiments, the locking mechanism may be in the form of a one-way valve, i.e., it can open in one direction and cannot open in a second opposite direction.

[0155] Shown in Figs. 9C-9D is the distal tip 905 of the distal portion 900 of the closure device before (Fig. 9C) and after (Fig. 9D) engagement with suture portion 9285. It can be appreciated that in Figs. 9C-9D a transverse cross-section of the suture portion 9285 is shown. In some embodiments, the slot 9054 has a substantially circular transverse cross-section, shaped and sized to securely receive the suture therein. The locking mechanism 9056 may be in the form of a one-way valve, positioned within the groove 9052, in proximity to the slot 9054. For example, the lock 9056 can open inwardly, i.e., toward a surface of the groove, but cannot open outwardly, i.e., away from the groove. In some embodiments, pushing the suture portion 9285 against the lock 9056 causes the lock to open, e.g., pivot inwardly about an axis, allowing the suture portion to enter the groove 9052. Once the suture portion 9285 passes the length of the lock (valve) 9056, such that external forces are no longer applied to the lock, the lock pivots back to its initial closed state. As the lock can only pivot inwardly, and cannot pivot outwardly, after the lock 9056 returns to its closed state, the suture portion 9285 is locked within the slot 9054 (or at least within the inner portion of the groove 9052), and it cannot be removed (radially) therefrom.

[0156] According to some embodiments, the movement (for example, deployment, rotation, pivoting, retraction, pulling, pushing, etc.) of any one of elements of the suture deployment mechanism described in Figs. 8A-8L hereinabove, such as the anchoring element, the suturing needles, the snare needle, the grasper needle, etc., may be controlled via a control handle of the closure device. In some embodiments, the control is manual. In some embodiments, the control is semi-automatic. In some embodiments, the control is automatic. The control handle for actuating the suture deployment mechanism described in Figs. 8A-8L may be substantially similar to any of the handles described in Figs. 4-5B hereinabove (with the required changes). In some embodiments, an additional carriage may be added to the rotating handle shown in Figs. 5A-5B, to facilitate separate deployment and / or retraction of the suturing needles (e.g., a giver needle and a receiver needle). In some embodiments, the control handle may include an additional knob coupled to the snare needle to enable manual gripping and pulling of the snare needle out of the closure device together with the threaded suture end.

[0157] Reference is now made to Fig. 10, which shows a block diagram of a method 1000 for deploying a suture on or around an opening in a blood vessel and / or closing thereof, using a closure device, according to some embodiments. In some embodiments, the suture deployment method is carried out prior to the medical procedure (e.g., placement of a stent), and once the medical procedure is completed, the opening in the blood vessel is closed using the previously placed suture. In some embodiments, the medical procedure is carried out first, and once the medical procedure is completed, the suture is deployed and the opening in the blood vessel is closed using the deployed suture immediately thereafter.

[0158] As shown in Fig. 10, at step 1002, a distal portion of a closure device (or at least the distal end thereof), as disclosed herein, is inserted into a target blood vessel through an opening or puncture. In some embodiments, the closure device may create the opening or puncture in the blood vessel. In some embodiments, the user (e.g., physician) then verifies that the distal end is positioned as desired within the blood vessel (e.g., using an indicator opening or a port in an access sheath, as described herein). At step 1004, an anchoring element is deployed within the blood vessel. Opening of the anchoring element may include pivoting or rotating the anchoring element about a rotation axis, as described herein. At step 1006, a first suturing needle (e.g., a receiver suturing needle) is deployed from its respective opening in the distal end of the closure device, to enter the blood vessel through the wall of the blood vessel, such that the tip of the needle is positioned in close proximity to the anchoring element or within a dedicated cavity within the anchoring element. At step 1008, a snare needle is deployed from the lumen of the first suturing needle. The snare needle may have a snare portion at or near its distal end or tip. In some embodiments, the snare needle is then passed through a longitudinal passage formed in the body of the anchoring element, from a first (proximal) end of the passage until its distal end or tip (e.g., snare portion) reaches a second (distal) end of the passage. In some embodiments, the second end of the first passage is at a crossing (or joining) with a second (transverse) passage formed in the body of the anchoring element. Thus, the snare portion of the snare needle may be positioned at the crossing of the two passages (channels) once fully deployed. The deployment of the snare needle and the passing thereof through the anchoring element’s longitudinal passage may be a single step or two separate steps. At step 1010, a second suturing needle (e.g., a giver suturing needle) is deployed from its respective opening in the distal end of the closure device, to enter the blood vessel through the wall of the blood vessel. In some embodiments, once deployed, the tip of the second needle is positioned in close proximity to the anchoring element or within a dedicated cavity within the anchoring element. In some embodiments, during or following deployment, the second needle is passed through the second (transverse) passage in the body of the anchoring element, such that the tip of the second needle extends beyond the anchoring element. As the snare portion of the snare needle is positioned at this stage at the crossing / joining of the first and second passages, passing of the second needle through the second passage includes passing of the second needle through the snare portion of the snare needle. At step 1012, a grasper needle is deployed from the lumen of the second (giver) suturing needle, such that a grasper portion located at or near the distal end or tip of the grasper needle extends beyond the tip of the second needle. In some embodiments, once the grasper needle is deployed, a free end of the suture, which is held by the grasper portion prior to deployment, is automatically released from the grasper portion, as described hereinabove. In some embodiments, release of the end of the suture from the grasper portion requires a separate action. At step 1014, the second needle and the grasper needle are retracted, leaving the suture threaded through the snare portion of the snare needle. In some embodiments, the second needle and the grasper needle are retracted simultaneously. In some embodiments, the grasper needle is first retracted into the lumen of the second suturing needle and the second suturing needle, with the grasper needle housed within its lumen, is retracted thereafter into the distal portion of the closure device. In some embodiments, the grasper needle and the giver needle are retracted in an alternate manner, as described hereinabove. At step 1016, the snare needle is retracted into the lumen of the first needle, through the longitudinal passage in the anchoring element, pulling therewith the threaded suture end. In some embodiments, the snare needle may be retracted / pulled manually out of the closure device (e.g., via its proximal end) together with the suture end threaded therethrough. At step 1018, the first suturing needle is retracted into the distal portion of the closure device. At step 1020, the anchoring element is closed (e.g., pivoted to its closed state). In some embodiments, the suture is released from the anchoring element prior to closing of the anchoring element. In some embodiments, the suture is released from the anchoring element during closing of the anchoring element. At step 1022, the closure device is removed from the blood vessel (and the patient’s body entirely), leaving a threaded suture on or around the puncture site in the blood vessel. According to some embodiments, a knot is deployed together with the suture. In such embodiments, following deployment of the suture and knot, the knot is pushed / tightened against the vessel wall, to ensure that the opening in the blood vessel wall is properly closed. Tightening of the knot may be carried out using the distal tip of the closure device, in which case the distal end of the closure device is reinserted into the patient’s body for this purpose. Alternatively, the knot may be tightened / pushed against the blood vessel using a separate device, such as a suture cutter unit. It is noted that method 1000 may include some or all of the described steps and that the method steps may be carried out in a different order.

[0159] According to some embodiments, a closure device is required for closing larger openings in blood vessels (e.g., carotid artery, femoral artery, femoral vein, etc.). A large bore access site is typically required for procedures involving high flow rates or the need to deliver large devices. For example, a large bore closure device may be required to close a common femoral artery access site after procedures like TAVR (transcatheter aortic valve replacement) or EVAR (endovascular aneurysm repair). In such procedures, catheters or sheaths with a large diameter (e.g., exceeding 8 French, exceeding 12 French) are introduced into the blood vessel. In some embodiments, where closure of a large bore is needed, more than one closure device may be used, so as to deploy more than one suture around the puncture. In some embodiments, a dedicated closure device, which can deploy two or more sutures simultaneously or sequentially, may be used for closing the opening.

[0160] Reference is now made to Figs. 11A-11C, which illustrate an exemplary distal portion of a closure device for use with large bore access sites, according to some embodiments. As shown in Fig. 11 A, the distal portion 1100 of the large-bore closure device may include more than one suture deployment mechanisms 1150A-1150B. it can be appreciated that although two suture deployment mechanisms are shown in Figs. 11 A- 11C, the closure device may have more than two deployment mechanisms (e.g., three, four, etc.), capable of deploying more than two sutures. In some embodiments, the distal portion 1100 of the large-bore closure device may be comprised of two (or more) distal portions as disclosed hereinabove (for example, distal portion 300 shown in Figs. 3A-3I, distal portion 800 shown in Figs. 8A-8L). In such embodiments, the suture deployment mechanisms 1150A-1150B, and the suture deployment process, may be substantially similar to those described hereinabove. In some embodiments, the distal portion of the large bore closure device is manufactured as a single unit having two or more suture deployment mechanisms. The distal portion of the large bore closure device may be in the form of a single tube / catheter accommodating therein or thereon the two or more suture deployment mechanisms, or it may be in the form of two or more tubes / catheters rigidly coupled to each other (e.g., fused, welded, glued), with each tube / catheter accommodating therein or thereon one suture deployment mechanism. In some embodiments, distal portion of the large bore closure device is manufactured as two or more separate distal portions, which are coupled at their proximal ends to a single control handle, for example. The two (or more) separate distal portions may be in contact with each other along at least a portion of their lengths, or they may be spaced apart. In some embodiments, the two or more suture deployment mechanisms (whether accommodated in or on a single tube / catheter or in multiple tubes / catheters) may be substantially parallel to each other, to allow deployment of a plurality of sutures in parallel positions. In some embodiments, the two or more suture deployment mechanisms may be disposed at an angle relative to each other, to allow different sutures to be placed at different positions and / or angles around / across the opening in the blood vessel. Shown in Fig. 11B is the distal portion 1100 of the closure device, with two anchoring elements 1110A-1110B, in an open state. Shown in Fig. 11C is the distal portion 1100 of the closure device, with the two anchoring elements 1110A, 1110B, in an open state, and with suturing needles 1116A-1116C in a deployed state. It can be appreciated that although only three suturing needles are shown, four suturing needles are deployed in Fig. 11C.

[0161] Reference is now made to Figs. 12A-12F, which show schematic side views of a distal portion of a closure device having an anchoring element at a distal tip thereof, according to some embodiments. As shown in Figs. 12A and 12D (which is a cross section of the opposite side of the view presented in Fig. 12A), distal portion 1200 of the closure device includes at a distal tip thereof a pivoting anchoring element 1210. The anchoring element shown in Fig. 12A is in a closed position. In some embodiments, when in a closed state, the anchoring element 1210 itself forms the tip of the closure device. Figs. 12B and 12E (which is a cross section of the opposite side of the view presented in Fig. 12B) show the distal portion 1200 of the closure device, with the distal tip anchoring element 1210 in an open position (prior to deployment of suturing needles). The anchoring element is configured to pivot about axis 1212. 12C and 12G (which is a cross section of the opposite side of the view presented in Fig. 12C) show the distal portion 1200 of the closure device, with the distal tip anchoring element 1210 in an open position, and suturing needles 1216A-1216B deployed. In some embodiments, the suturing needles are deployed substantially simultaneously. In some embodiments, the suturing needles are each deployed separately. The suture deployment process may be, for example, similar to the process described hereinabove in Figs. 3 A-3I, or to the process described hereinabove in Figs. 8A-8L.

[0162] Reference is made to Figs. 13A-13B, which show perspective and transparent side views, respectively, of a distal end of a closure device, according to some embodiments. As shown in Fig. 13A, suturing needles 1316A-1316B are engaged at the distal tip 1312 of the distal region / portion 1300 of the closure device so as to pass a suture (not shown) from a giver suturing needle 1316A to a receiver suturing needle 1316B. In some embodiments, the receiver needle 1316B is configured as a snare needle having a snare portion 1318 at its distal end. In some embodiments a separate snare needle (not shown) is deployed out of the receiver needle 1316B. Fig. 13B shows a transparent view of distal tip 1312, showing needles 1316A-1316B meeting at the tip of the closure device. A suture (not shown) can then be passed from the giver needle 1316A to the snare portion of either the receiver needle 1316B itself or a snare needle protruding out of the receiver needle 1316B, through a dedicated location in the distal tip 1312 of the closure device.

[0163] According to some embodiments, a suture deployment mechanism may make use of various means for passing a suture between suturing needles. Reference is now made to Figs. 14A-14D, schematically illustrating elements of another suture deployment mechanism, during various stages of passing a suture, according to some embodiments. As shown in Fig. 14A, suture deployment mechanism 1400 (located at a distal portion of a closure device), includes housing 1404 (which may be part of an anchoring element), which harbors holder 1414. Holder 1414 may be in the form of a tube or cylinder or an hourglass, and is configured to hold and release suture gripping element 1412. Suture gripping element 1412 is configured to guide and attach to a suture 1428, and enable the passing / exchanging of the suture (or suture end) between suturing needles. As shown in Fig. 14A, at the beginning of the suture deployment process, a giver suture needle 1416A (which may be at least partially hollow) is capable of reversibly attaching to the suture gripping element 1412, and guide it to housing 1404, and in particular, to holder 1414. Giver suturing needle 1416A may protrude / advance from its corresponding lumen in the distal region of the closure device, while being associated (at a distal end thereof) with suture gripping element 1412. Once suture gripping element 1412 engages with holder 1414, the suture gripping element is released from the giver suturing needle, which can consequently retract to its initial position, within the distal region of the closure device, as shown in Fig. 14B. Next, as shown in Fig. 14C, a receiver (taker) suturing needle 1416A may protrude / advance from its corresponding lumen in the distal region of the closure device, such that the distal end thereof reaches housing 1404 at the region of holder 1414, and connects to suture gripping element 1412. Once the suture gripping element 1412 is associated with receiver suturing needle 1416B, the suture gripping element 1412 is released from the holder 1414. As shown in Fig. 14D, once associated with the suture gripping element 1412, the receiver suturing needle 1416B is configured to be retracted, consequently pulling the suture 1428 with it, to thereby pass one end of the suture from side to side (i.e., between the giver needle and the receiver (taker) needle). The threaded suture can then be knotted or secured to each other, by any suitable means, such as, by tying the ends of the suture and / or placing a pre-tied knot, or any other securing member, over the free ends of the suture and tightening thereof on the puncture region, for example using a knot pusher-cutter, and the like, as described in further detail hereinbelow.

[0164] Reference is now made to Fig. 15, which illustrates an exemplary distal end of a suturing needle, according to some embodiments. As shown in Fig. 15, distal end 1502 of suturing needle 1500 includes a plurality of project! ons / arms, such as project! ons / arms 1504A-1504C, which are capable of expending away from each other or collapsing toward each other, thereby facilitating the holding or releasing of a suture or a suture gripping element. In some embodiments, the protrusions may be present in a collapsed state (and having a pointed or penetrating configuration) for penetrating the blood vessel, and may open or expand after inserted into the blood vessel, for example, after a suture or a snare needle is passed within. In some embodiments, the needle may be made of any suitable material, such as metal, plastic, etc. In some embodiments, the arms may be an integral part of the needle body, or they may be associated with the needle body.

[0165] Reference is now made to Fig- 16, which shows a schematic illustration of suturing needle association with a suture, according to some embodiments. As shown in Fig. 16, suture 1608 is associated with (i.e., held, gripped, bound to, etc.) targeting element 1606, at an end thereof. Targeting element 1606 is configured to reach a corresponding opening 1604 of suturing needle 1600. Once reaching the opening, targeting element 1606 may reversibly (or irreversibly) lock into place, for example by associating a groove on the front face of targeting element 1606 with latch 1602 in the body of suturing needle 1600. In some embodiments, the size and shape of targeting element 1606 is designed so as to fit the corresponding opening 1604 of suturing needle 1600, and latch 1602. Thus, by the association of the targeting element and the needle, the suture may be reversibly connected to the needle. In order to release the suture from the needle (for example, for passing to another needle), the latch may be moved (for example, by an internal pushing element, internal needle, etc.) and allow the release of the targeting element and the suture from the needle. In some embodiments, the targeting element 1606 may be initially reversibly coupled to a giver suturing needle (not shown), with its pointed tip 1607 facing distally and through engagement with a receiver suturing needle (e.g., needle 1600), the targeting element 1606, with the suture attached thereto, may be passed to the receiver needle and captured by its latch 1602 (or any other capturing mechanism), resulting in the release of the targeting element 1606 from the giver needle.

[0166] Reference is now made to Figs. 17A-17B illustrating a distal region of a closure device 1700, having a pivotable anchoring element 1710 hingly coupled to a main shaft 1705 by means of at least one hinge 1712, and deployable from a distal end of the distal region. Fig 17A shows the anchoring element 1710 after being deployed from within distal region of the closure device into a blood vessel 1720, still in a folded state. Fig. 17B shows the anchoring element 1710 positioned within a blood vessel 1720, after having been pivoted about hinge 1712 to its open state, and repositioned (e.g., pulled) to as to be substantially adjacent and parallel to the inner wall of the blood vessel. In some embodiments, after deployment, the anchoring element may be substantially perpendicular to the longitudinal axis of the main shaft 1705 and the distal region, as shown in Fig. 17B. In other embodiments, the deployed anchoring element may be positioned at an angle relative to the longitudinal axis of the main shaft 1705 and the distal region. Further shown in Fig. 17A is a passageway 1714 in the anchoring element, through which a suture (not shown) can be threaded. In some embodiments, the distal portion of the closure device may include at least two lumens 1702A-1702B each of which includes a proximal end (not shown) positioned at the proximal end of the closure device, and a distal end configured for positioning against the blood vessel’s outer wall. When the distal ends of the lumens 1702A-1702B are aligned with the passageway 1714 of the deployed anchoring element 1710, a suture may be threaded from the proximal end of one lumen, for example lumen 1702A, to the distal end thereof, through passageway 1714, into the distal end of the second lumen, for example lumen 1702B, to the proximal end thereof. Figs. 17C-17D illustrate a needle 1730 and suture 1740 being threaded through the lumens 1702A-1702B and the passageway 1714 of the anchor element 1710.

[0167] Reference is now made to Figs. 18A-18B illustrating a pivotable anchoring element 1810, having two body portions reversibly coupled to each other, allowing the passing of a suture therewithin, in a closed position (holding the suture) (Fig. 18A), and allowing the release of the suture, in an open position (Fig. 18B). As shown in Fig. 18A, anchoring element 1810 is made of two body portions, 1812A-1812B, which are reversibly coupled to each other. Further shown is suture 1860 passing in a passageway formed by the alignment of grooves of the two body portions when the two portions are coupled. Once the suture 1860 is passed, the two body portions may be decoupled from each other, as shown in Fig. 18B Once decoupled, the two body portions may be retracted back into the closure device, reconfiguring into the retracted configuration, while the suture is left in the blood vessel.

[0168] Reference is now made to Figs. 19A-19C illustrating a distal portion 1900 of a closure device, according to some embodiments. The distal portion 1900 of the closure device may include a fixation member (or - anchoring element) which is initially stored within the body of the distal portion, as shown in Fig. 19A. The fixation member 1910 may be configured as a bendable element, which can, upon deployment, protrude from one of more side walls of the distal portion’s body and assume a pre-shaped configuration, as shown in Fig. 19B The fixation member may include a support element, which is configured to provide counterforce against the inner wall of the blood vessel, and one or more alignment elements, which are configured to facilitate in the alignment between preshaped hollow channels of the distal portion 1900, as shown in Fig. 19C. According to some embodiments, the alignment elements may be configured to guide and facilitate threading of the needle (and suture 1920) directly, e.g., when the distal end of the closure device does not include pre-shaped hollow channels.

[0169] According to some embodiments, after the suture has been threaded and positioned on or around the opening or puncture in the blood vessel, as detailed above, either before or after the medical procedure is carried out, a knot or a different closing member may be formed and / or placed on the suture ends, adjacent the wall of the blood vessel (internally and / or externally), to thereby close and seal the puncture. Forming a knot may be facilitated using any suitable means, such as, by manually tying the ends of the suture, deploying a pre-formed knot, and the like. In some embodiments, the placement and / or tightening of the knot and / or cutting the suture ends thereafter, may be performed using the closure device or using a separate suture cutter unit (also referred to as “knot pusher unit” or “pusher-cutter unit” or “cutter unit”).

[0170] According to some embodiments, the system disclosed herein may include a suture cutter unit, that may be a standalone unit, or associated with the closure device. Such a unit may be used to push a knot or other securing / closing member (such as, a plastic, metal or other substantially flat member having aperture(s) or slot(s), as shown for example, in Figs. 21A-21F), to hold and tighten the suture ends on the blood vessel wall. In some embodiments, the cutter unit may further allow cutting the suture ends at a desired or predetermined distance from the knot (or a different closing member). In some embodiments, the pusher-cutter unit may further allow the pushing or applying of substances, such as collagen, in close proximity to the puncture in the blood vessel (for example, on the external region thereof). The application of such substances may be performed prior to, during and / or after the deployment of the knot or securing / closing member. According to some embodiments, the cutting of the suture ends after tightening the knot (or securing of the securing / closing member) is facilitated after the collagen has been applied.

[0171] According to some embodiments, in order to enhance closure of the opening in the blood vessel, the closure device may be configured to dispense one or more formulations, compositions or solutions of thrombogenic materials, such as collagen, at or in close proximity to the suturing site. In some embodiments, the dispensing may be facilitated via a dispensing tube having a distal opening in close proximity to the positioning of the suturing needles in or relative to the anchoring element. In some embodiments, the thrombogenic material may be dispensed via a dispensing lumen in one or both of the suturing needles. In some embodiments, the thrombogenic material may be provided to the suturing site via the cutter unit, e.g., concomitantly with the tightening of the knot on the puncture region and / or placing of a pre-tied knot, or any other securing member, over the free ends of the suture, and tightening thereof on the puncture region. The thrombogenic material, such as collagen, may be provided in the form of a gel, solid sheets, and the like. In some embodiments, a depot of thrombogenic material may be housed in the closure device body, or in the handle thereof.

[0172] Reference is now made to Figs. 20A-20D, showing a pusher-cutter unit, according to some embodiments. The pusher-cutter unit 2000 allows the pushing of a knot (or other closing member) onto the free ends of the suture adjacent the blood vessel’s external wall, and cutting of the suture ends thereafter. As shown in Fig. 20A, the pusher-cutter unit 2000 may include, at its distal end, a snare 2002 to pass the free suture ends 2060A-2060B therethrough. The unit 2000 may further include at its distal end, proximally to the snare 2002, a pre-formed knot 2040 (or other closing member). In some embodiments, the unit may include thrombogenic material (e.g., collagen) 2050 adjacent to the pre-formed knot 2040, either proximally or distally thereto. After the suture ends 2060A-2060B are passed through the snare 2002, a snare handle 2004 is pulled, to pull the suture ends 2060A- 2060B through the collagen and the closing member (e.g., knot), and out of the unit through a side opening 2006, as shown in Fig. 20B. Further shown in Figs. 20A-20B is a handle 2008 for pushing the closing member (e.g., knot 2040) and, optionally, collagen 2050, over the free ends of the suture, a cutter connector 2010, shown in a retracted position in Figs. 20A-20B, and a cutter knob 2012 which is configured to activate the cutter. After the suture ends are pulled out of the side opening using the snare 2002 and the snare handle 2004, the user presses the handle 2008, thus pushing the knot 2040 and the collagen 2050 out of the distal end of the unit 2000, over the suture ends, and onto the opening in the blood vessel. In some embodiments, further pressing of the handle 2008 also tightens the deployed knot onto the opening in the blood vessel, for example by means of a spring 2014, to secure the closing of the opening. In some embodiments, pushing the handle 2008 also pushes the cutter connector 2010 distally, until it engages with the cutter knob 2012, as shown in Fig. 20C. As shown in Fig. 20D, when the cutter connector 2010 is engaged with the cutter knob 2012, operating the cutter knob 2012, for example, pulling of the cutter knob 2012, activates the cutter, to facilitate the cutting of the suture ends 2060A-2060B proximally to the deployed knot 2040, thereby releasing the knot 2040 from the pusher-cutter unit 2000, and leaving the tight knot 2040 (with or without collagen 2050) on the blood vessel wall, thus closing the puncture in the blood vessel.

[0173] According to some embodiments, in order to secure and tighten the suture ends on the blood vessel opening, a knot (such as a pre-formed knot) may be used. In some embodiments, in addition to or alternatively to the knot, a different securing / closing member may be used. The closing member may be placed on the ends of the suture to thereby secure the suture ends together and tighten the suture on the blood vessel opening. Reference is now made to Fig. 21A-21F, which show exemplary configurations of a closing member which can be used instead of, or in addition to, a pre-formed knot (with or without collagen). In some embodiments, the closing member may have one or more slots and / or openings through which the suture ends can be passed. According to some embodiments, as described, for example, in Figs. 8A-8L, the closure device may be configured to deploy a knot together with the suture. Further, the closure device may include at the distal tip of its distal portion a knot pushing mechanism, as disclosed, for example, in Figs. 9A-9D. Cutter units which are configured for use in conjunction with such closure devices may be used primarily for cutting the suture ends. In some embodiments, the cutter unit may further be used in such cases for applying substances, e.g., collagen, in close proximity to the puncture in the blood vessel and / or onto the deployed suture knot.

[0174] According to some embodiments, the devices and systems disclosed herein may be used for treating carotid artery diseases, and specifically during CAS. Even more specifically, the present disclosure discloses a transcarotid access catheter for use during direct percutaneous access to the common carotid artery CCA (transcarotid access). The transcarotid access catheter may be include a two-part access sheath, as disclosed hereinbelow. According to some embodiments, the transcarotid access catheter may include the closure device, i.e., the closure device may be integral with the catheter, such that it is deployable through one or more lumens of the catheter. More specifically, in some embodiments, the transcarotid access catheter may include elements of the disclosed closure device, such that the suture deployment mechanism, for example, is deploy able through one or more lumens of the catheter. According to other embodiments, the closure device may be separate from the transcarotid access catheter, as described herein.

[0175] According to some embodiments, the disclosed devices and systems may include at least one distal balloon (or another anchoring / blocking member) and / or filter. Such filter(s) is to be positioned, for example, in the internal carotid artery, distal to the region of stenting. The filter is intended to capture embolic particles to prevent passage into the cerebral vasculature. In some embodiments, the distal balloon(s) and / or distal filters may be part of (e.g., integral with) the transcarotid access sheath (e.g., a two-part sheath). In some embodiments, the distal balloon(s) and / or distal filters may be separate components which can be introduced into the desired blood vessel through the transcarotid access sheath (e.g., a two-part sheath).

[0176] According to some embodiments, the devices and systems disclosed herein may include at least one marker (e.g., radiopaque marker), to facilitate visualization of the device, or certain components thereof, using an imaging system. The at least one marker may be positioned, for example, on or adjacent to one or more of the anchoring / blocking members (e.g., balloons), the distal intravascular filter, or the like.

[0177] It is noted that it is within the scope of the present disclosure to provide a femoral carotid access system and / or a jugular carotid access system, which comprises the closure device as disclosed herein (or elements thereof), either as an integral part of the femoral / jugular carotid access catheter or as a separate device of the system.

[0178] According to some embodiments, there are provided herein kits and systems, including the closure device as disclosed herein, and one or more of: an access catheter / sheath (e.g., a transcarotid access catheter), a reverse flow device, a distal balloon (or other occluding member), a distal filter, a guidewire and / or a suture cutter unit. Each possibility is a separate embodiment.

[0179] According to some embodiments, a balloon catheter may be used to provide access to the blood vessel, anchor therein and block the vessel, to enable reversing of the blood flow, as further described hereinbelow. Alternatively, the access and / or the anchoring and / or blocking may be provided using a dedicated sheath or port, as further described hereinbelow.

[0180] Reference is now made to Figs. 22A-22B, showing schematic illustrations of a balloon catheter (e.g., a transcarotid access catheter) for providing access to a blood vessel (e.g., the common carotid artery), according to some embodiments. Shown in Fig. 22A, is balloon catheter 2200, having at a proximal region thereof one or more connectors 2210 (for example, for inflating the balloon, for connecting a reverse flow device, for inserting a stent, and the like), prior to, or after positioning of the suture using the closure device as disclosed herein. Catheter 2200 includes at a distal end thereof a balloon 2220. As shown in Fig. 22B, once the balloon 2220 is positioned within the blood vessel 2205, it may be inflated within the blood vessel, to anchor therein and block the vessel.

[0181] Reference is now made to Fig. 23, showing the proximal region of the catheter, according to some embodiments. The proximal end of the catheter 2300 may include multiple connectors, for example three connectors 2302A-2302C. In some embodiments, the connectors may be used to connect various units / devices for various medical procedures (such as, insertion of medical tools, insertion of stent(s), insertion and / or inflation of balloon(s) or other anchoring / blocking members), and the like. For example, one connector, e.g., connector 2302A, may be used for connecting a reverse-flow device 2310, which is used to draw blood from the blood vessel and, optionally, return the drawn blood, filtered, into a different blood vessel, as described in further detail hereinbelow. The additional connectors (2302B-2302C) may be used, for example, for inserting a stent, for inflating the balloon(s), etc.

[0182] According to some embodiments, the system may include a dedicated access sheath. The dedicated access sheath may include an inflatable balloon for anchoring and occluding the blood vessel, similarly to a balloon catheter. Alternatively, the anchoring and occluding member (also referred to as “anchor”) may be in the form of an expandable structure. In some embodiments, the anchor is mounted on the sheath. In some embodiments, the anchor is housed within the sheath and is deployed from the distal end of the sheath upon positioning of the distal region of the sheath within the blood vessel. In order to occlude the blood vessel and obstruct blood flow, the anchor may be formed as a tight mesh. Additionally or alternatively, the anchor may be covered by a polymer (e.g., polyurethane, polyamide, polyethylene, pibax, silicone, etc.). In some embodiments, the dedicated access sheath includes a single part. In some embodiments, the dedicated access sheath includes at least two parts which can be connected and disconnected to and from each other. In some embodiments, such as when femoral access is desired, the dedicated access sheath may include an expandable portion along at least a part of its length, to reduce resistance of blood flow. The expandable portion may be a flexible structure which is expandable upon pulling of a wire, or it may a pre-shaped structure and the access sheath may be delivered within an additional external sheath such that upon retraction of the external sheath, the expandable portion automatically expands to its pre-shaped form, or the like.

[0183] Reference is made to Figs. 24A-24B, illustrating a two-part access sheath, according to some embodiments. Fig. 24A shows the two-part sheath 2400 when the two parts are disconnected from each other. Fig. 24B shows the two-part sheath 2400 when the two parts are connected to each other. In some embodiments, the sheath 2400 includes a first (proximal) part 2410 and a second (distal) part 2420. In some embodiments, the proximal part 2410 of the sheath may include, at its proximal end, a hemostatic valve 2412 or any other component which can prevent blood backflow (i.e., prevent blood from exiting through the proximal end of the sheath) while allowing insertion of medical tools (e.g., a stent delivery catheter) through the sheath and into the blood vessel. In some embodiments, the proximal part 2410 includes a reverse flow port 2414 for connecting thereto a reverse flow device (not shown in Figs. 24A-24B). The proximal part 2410 may include, at its distal end, a connector 2416 that enables connection of the proximal part 2410 to the distal part 2420 of the sheath, as well as disconnection therefrom. The connection between the two parts may be a snap-fit connection, a threaded connection (e.g., one part may include a pin or a longer protrusion, and the other part may include a rail within which the pin / protrusion can be received and moved as one of the two parts is rotated relative to the second part), or any other suitable connection. In some embodiments, the proximal part includes a first portion of the connector and the distal part includes a second portion of the connector, and engagement between the first and second connector portions establishes the connection between the proximal and distal parts of the sheath. In some embodiments, the distal part 2420 of the sheath may include at or near its distal end a balloon 2422 or another anchor suitable for anchoring the sheath within the blood vessel and preventing blood flow around the sheath. If the access sheath includes a balloon, the distal part 2420 may include an inflation port (not shown), to enable connection of an inflation device, such as a syringe, to the sheath, and inflation of the balloon. In some embodiments, the bottom part 2420 of the sheath may include a hemostatic valve 2424 at its proximal end, to prevent blood from leaking through the proximal end of the distal part 2420 of the sheath, when the proximal part 2410 of the sheath is disconnected from the distal part 2420 of the sheath. In some embodiments, the distal part 2420 may include a flushing port 2426 at or near its proximal end. The flushing port 2426 may be used, for example, for cleaning the distal part 2420 (e.g., by injecting saline), or for injecting contrast. In some embodiments, the flushing port 2426 may further be used for providing indication as to the positioning of the distal part of the sheath relative to the blood vessel and / or to the positioning of the distal portion (or at least its distal end) of the closure device within the blood vessel when the distal portion of the closure device is inserted into the blood vessel through the distal part of the sheath, as disclosed hereinbelow.

[0184] In some embodiments, the medical procedure (e.g., stent placement), is carried out first, and placement of the suture on or around the opening in the blood vessel using the closure device is carried out after completion of the medical procedure. In such embodiments, the two-part access sheath 2400 is initially used in its connected state (i.e., the two parts are connected to each other). After completion of the medical procedure, the proximal part 2410 is disconnected from the distal part 2420, leaving the distal part in place, i.e., such that its distal end remains positioned in the blood vessel. In some embodiments, the distal portion of the closure device is then inserted into the blood vessel through the distal part 2420 of the sheath, and the suture is deployed in its desired position around the opening. In some embodiments, the expandable member (e.g., balloon) is collapsed (e.g., deflated) prior to or following insertion of the distal portion of the closure device into the blood vessel through the distal part 2420 of the sheath. In some embodiments, once the suture is deployed, the closure device is removed from the distal part 2420 of the sheath, and the distal part 2420 of the sheath is then removed from the blood vessel (i.e., the closure device and the distal part of the sheath are removed separately from the blood vessel). In some embodiments, upon insertion of the distal end of the closure device through the distal part 2420 of the sheath, the distal end of the closure device and the distal part 2420 of the sheath are coupled to each other (e.g., via a snap- fit connection, or any other suitable connection), such that following the suture deployment process, removal of the closure device from the blood vessel removes with it the bottom part 2420 of the sheath coupled thereto. In some embodiments, the coupling between the distal portion of the closure device and the distal part 2420 of the sheath is reversible. In such embodiments, if the deployment of the suture failed (e.g., due to a malfunction in the suture deployment mechanism or in the control handle), the distal part of the sheath may be decoupled from the distal portion of the closure device, reinserted into the blood vessel, and used with a new closure device, i.e., the physician may insert the distal portion of a new closure device into the blood vessel through the distal part of the sheath and repeat a suture deployment process with the new closure device.

[0185] In some embodiments, since once coupled to each other the relative position between the distal part 2420 of the sheath and the distal portion of the closure device is known (and fixed while coupled), the flushing port 2426 may be used for providing indication as to the positioning of the distal portion of the closure device within the blood vessel by the providing indication as to the positioning of the distal part 2420 of the sheath relative to the blood vessel. In some embodiments, the coupling is configured such that, when coupled, the distal tip 2428 of the distal part 2420 of the sheath 2400 is located above the anchoring element of the closure device. When the tip 2428 is positioned within the blood vessel, blood can enter the space between the distal part 2420 of the sheath and the distal portion of the closure device through the tip 2428, and drip out of the flushing port 2426 which is located externally to the patient’s body. The user (physician) then controllably retracts proximally (pulls) the closure device and the distal part 2420 of the sheath coupled thereto until blood no longer emerges from the flushing port 2426, indicating that the distal tip 2428 is out of the blood vessel. Once the tip 2428 is out of the blood vessel, the anchoring element, which is located distally to the tip 2428, can be opened.

[0186] In some embodiments, the medical procedure is carried out after placement of the suture around the opening using the closure device. In such embodiments, the two-part access sheath 2400 is initially used in its disconnected state (i.e., the two parts are disconnected from each other), that is, only the distal part 2420 (i.e., its distal end) is initially inserted into the blood vessel. The distal portion of the closure device is then inserted into the blood vessel through the distal part 2400 of the sheath, and the suture is deployed in its desired position around the opening using the closure device. Once the suture is deployed, the closure device is removed from the distal part 2420 of the sheath, and the proximal part 2410 of the sheath is then connected to the distal part 2420, to enable execution of the medical procedure therethrough. In some embodiments, the distal part 2420 of the sheath may be initially coupled to the closure device, such that the closure device and the distal part of the sheath are inserted together into the blood vessel. Once the suture deployment is completed, the closure device is disconnected from the distal part of the sheath, leaving the distal part of the sheath in the blood vessel.

[0187] According to some embodiments, the system may include a dedicated access port. The access port may be initially assembled onto the closure device and left deployed in the blood vessel after the suture has been deployed, until the medical procedure is completed. In some embodiments, after removal of the closure device, the dedicated access port may be left in the blood vessel, such that a distal end thereof resides within the blood vessel (e.g., an artery), and the proximal end thereof resides outside the body. Reference is made to Figs. 25A-25C, illustrating an exemplary access port, according to some embodiments. In some embodiments, the access port may be pre-assembled onto the distal end of a closure device. As shown in Fig. 25A, closure device 2500, is associated with access port 2520, which is configured to be deployed into a blood vessel 2505, as shown in Fig. 25B. The deployment of the access port may be facilitated by dedicated control elements on the closure device (such as, for example, a handle or knob in the control handle). As shown in Fig. 25C, after the closure device is removed from the blood vessel (i.e., after the suture has been deployed, as detailed above herein), the access port 2520 may be left in association with the blood vessel, such that the proximal region thereof is external to the body, and the distal end thereof is positioned within the blood vessel. Such a port may allow access to the blood vessel, for example, for inserting medical tools, stent(s), balloon(s), catheter(s), filter(s), and the like. In some embodiments, the access port may be assembled on the closure device and deployed (i.e., disconnected from the closure device so as to remain with its distal end within the blood vessel) using the device after the suture is deployed and prior to removal of the closure device from the blood vessel. In some embodiments, a balloon catheter may be inserted through the port. In some embodiments, the access port may include a balloon or another anchor at or near its distal end (not shown), such that there is no need for a separate balloon catheter. In the latter case, a catheter / sheath may be coupled to the access port using a dedicated connector. For example, the proximal end of the access port may include a connecting portion (e.g., including a hemostatic valve) that can be engaged by the distal end of the catheter.

[0188] According to some embodiments, during the medical procedure, the flow of blood is reversed using a reverse flow device. Blood may be actively drawn (for example, using a syringe or a pump generating suction) or passively drawn from the blood vessel into a reservoir of the reverse flow device. In some embodiments, the drawn blood it returned (e.g., pushed back from the reservoir) to the patient’s body, at a later stage, after the medical procedure (for example, stenting, clearing of blood clots, suturing, etc.) is performed. In some embodiments, the passive flow of blood to the reservoir may be facilitated by pressure differences between the blood vessel and the reservoir.

[0189] Reference is made to Figs. 26A-26C, illustrating a reverse flow device, according to some embodiments. Fig. 26A shows a perspective view of a reverse flow device 2400 (without its cover, which is shown in Fig. 23), having a syringe barrel (also referred to as “reservoir”) 2602 (shown in Fig. 26 A without its surrounding wall / s, which may be the cover of the reverse flow device)) and a filtering unit 2604. Also shown is a conduit 2606 connecting the device to the blood vessel (e.g., via an access catheter, sheath or port). In some embodiments, the flow reversal mechanism includes a piston rod 2603 and a piston 2605 coupled to the piston rod 2603 at or near its distal end. The piston rod 2603 may be at least partially threaded along its length (e.g., configured as a screw), as shown in Fig. 26A, and the reverse flow device may further include a drive nut 2622, such that when the threaded piston rod 2603 engages with inner threads (not shown) of the drive nut 2622, rotation of the piston rod 2603 results in linear of movement of the piston rod 2603 and the piston 2605 distally or proximally (depending on the direction of rotation) within the syringe barrel 2602. In some embodiments, the piston 2605 can move linearly without rotating. The drive nut 2622 may be positioned in a proximal portion 2620 of the reverse flow device 2600. In some embodiments, the piston rod 2603 can move linearly (i.e., be pushed / pulled) additionally or alternatively to its rotational movement. In some embodiments, the piston rod 2603 may be transitioned between linear movement and rotational movement. In some embodiments, the drive nut 2622 may be moved between a disengaged state, in which it is disengaged from the piston rod 2603, allowing the piston rod to be linearly pushed / pulled, and an engaged state, in which it is engaged with the piston rod 2603, allowing the piston rod to be controllably rotated. In some embodiments, the nut 2622 includes an inner opening (not shown), which includes inner threads traversing a portion of its circumference, such that in the engaged state, the threaded inner portion (not shown) of the nut 2622 engages external threads of the piston rod 2603, and in the disengaged state, the threaded inner portion of the nut 2622 does not engage the threads of the piston rod 2603. In some embodiments, the nut may include at least two conjugated inner openings or slots, a non-threaded slot and a threaded slot having inner threads traversing at least a portion of its circumference, such that in the disengaged state the piston rod is positioned in the non-threaded slot, and in the engaged state the piston rod is positioned in the threaded slot. In some embodiments, the nut 2622 can be moved laterally (e.g., in a plane substantially parallel to the longitudinal axis of the piston rod 2603), to be transitioned between the engaged state and the disengaged state. Shown in Figs. 26B-26C is a filtering unit 2604, according to some embodiments. The filtering unit includes a filtering element (also referred to as “filter”) 2610, which is configured to filter the blood as it is returned into the body after the procedure (if returned into the body). In alternative embodiments, the blood may be filtered as it is drawn from the blood vessel into the reservoir. It can be appreciated that although shown as cone shaped in Figs. 26B- 26C, the filter may assume any suitable configuration. The filtering unit 2604 may further include one or more (for example, three or four) one-way valves positioned between the filter 2610 and the reservoir, some on the way into the reservoir, for example valves 2608A-2608C, and some on the way out of the reservoir, for example valve 2608D. In some embodiments, a higher number of valves are positioned on the way into the reservoir, relative to the number of valves positioned on the way out of the reservoir. This way, blood can be easily drawn out of the blood vessel, but returned into the blood stream after the medical procedure, through the filter, in a slower and more controlled manner. The reverse-flow device 2600 may further include one or more irrigation ports 2612 (for example, for allowing passage of saline, buffers, etc.). After the procedure, the blood in the reservoir may be returned into the body (for example, to a vein in the arm or the leg), by moving (pushing or rotating) the piston rod distally within the syringe barrel).

[0190] Shown in Figs. 27A-27C is a filtering unit, according to some embodiments. Shown in Fig. 27A is a front view of filtering unit 2700. The filtering unit may include a casing 2702 which houses the elements of the filtering unit. A filter access knob 2704 may be disposed in a wall of the casing 2702, to enable access to the filter (shown in Figs. 25B-25C) positioned within the casing. The access knob 2704 may be configured to be rotated and removed from the casing 2702 to allow access to the filter. In some embodiments, the access knob 2704 has to be pushed inwardly first to enable its rotation (while maintained pushed) and removal. In some embodiments, the access knob 2704 may be configured to be opened (e.g., similarly to a door), such as by pivoting about a hinge. The filtering unit 2700 may further include an air vent (also referred to as “air check valve”) 2706, to allow air removal from the filtering unit.

[0191] Shown in Fig. 27B is a cross-sectional view of filtering unit 2700 along line BB shown in Fig. 27A. The filtering unit 2700 includes an inlet port 2708 through which blood from the blood vessel can enter (e.g., be drawn into) the filtering unit 2700. In some embodiments, the filtering unit 2700 includes an inner chamber 2710 which receives the blood drawn (either actively or passively) from the blood vessel. In some embodiments, the filtering unit 2700 includes an outlet port 2712, which allows blood from the inner chamber 2710 to flow out of the filtering unit (and the flow reverse unit entirely), for example, to a different blood vessel, as described in further detail hereinbelow. In some embodiments, the drawn blood is directed from the inner chamber 2710 into the reservoir of the flow reverse unit (the reservoir base 2714 is shown in Fig. 27B) through a reservoir inlet 2716. In some embodiments, the filtering unit 2700 may include at least one floating member, for example, a first floating member 2718 and a second floating member 2720 (shown in Fig. 27B as round members having a circular cross-section, but can have any other suitable shape). The first floating member 2718 may be movable within the inner chamber 2710 to allow or prevent passage of blood between the inlet port 2708 and the reservoir inlet 2716. The second floating member 2720 may be movable within an air vent chamber 2722, which connects between the reservoir base 2714 and the air vent 2706.

[0192] In some embodiments, the reverse flow device may have several possible operational modes, such as, but not limited to: 1) Atmospheric pressure mode - in this mode, the outlet port 2712 is closed, the air vent 2706 is open, and the piston (not shown) is pulled back (proximally) at least partially within the reservoir. In this state, the pressure in the reservoir is atmospheric pressure, whereas the pressure in the blood vessel (e.g., carotid artery, femoral artery) is higher than atmospheric pressure. Once the inlet port 2708 is opened, blood from the blood vessel flows into the reservoir due to the pressure gradient between the blood vessel and the reservoir. The blood flows into the reservoir through the inner chamber 2710, pushing aside the first floating member 2718, and through the reservoir inlet 2716. In some embodiments, when the reservoir is filled with blood (e.g., completely full, depending on the angle in which the reverse flow device is held), blood enters the air vent chamber 2722 and pushes the second floating member 2520 against the air vent 2706, thus preventing leakage of blood through the air vent 2706. 2) Passive vacuum mode - in this mode, all three ports are initially closed (the air vent 2706, the inlet port 2708 and the outlet port 2712). The piston is then pulled (proximally) within the reservoir, creating a vacuum within the reservoir. Once the inlet port 2708 is opened, blood from the blood vessel flows into the reservoir due to the pressure gradient between the blood vessel and the reservoir. 3) Active vacuum mode - in this mode, the air vent 2706 and the outlet port 2712 are closed, and the piston is pushed (distally) within the reservoir until it rests against the reservoir base 2714. Once the inlet port 2708 is opened, the user (e.g., physician) pulls the piston proximally within the reservoir, to actively draw blood from the blood vessel into the reservoir. 4) Blood retrieval mode - in this mode, the blood accumulated in the reservoir is returned into the patient’s body. In this mode, the outlet port 2712 is open and coupled to a different blood vessel (e.g., a vein in the arm or the leg) via a tube / catheter (not shown). The air check valve 2706 and inlet port 2708 may be either open or closed (the air check valve 2706 is effectively closed from inside the filtering unit by floating member 2720, and the inlet port will be effectively closed from inside the filtering unit by floating member 2718, as described hereinbelow). The piston is then pushed (distally) within the reservoir, pushing the blood from the reservoir back into the inner chamber 2710 of the filtering unit 2700. As the blood flows into the chamber 2710, it pushes the floating member 2718 towards the inlet port 2708, thus closing (blocking) the inlet port 2708, and preventing blood from flowing back into the blood vessel from which it was drawn, e.g., the carotid artery (in case the inlet port is open). Since the outlet port 2712 is open, the blood now accumulated in the inner chamber 2710 flows through the filter 2724 and the outlet port 2712 into the second blood vessel (e.g., a vein in the arm or the leg) to which the outlet port is coupled. 5) Bypass mode - in this mode, blood is not drawn into the reservoir, but is returned, filtered, directly into the patient’s body. In this mode, the outlet port 2712 is open and coupled to a different blood vessel (e.g., a vein in the arm or the leg) via a tube / catheter (not shown), the piston is pushed (distally) within the reservoir until it rests against the reservoir base 2714, and the air vent 2706 may be either open or closed (if a small gap is left between the piston and the reservoir base and blood drawn from the blood vessel reaches the reservoir base, it will enter air vent chamber 2722 and push floating member 2720 against the air vent 2706, effectively closing air vent 2706 from inside the filtering unit). In this state, once the inlet port 2708 is opened, blood from the blood vessel (e.g., carotid artery) flows directly into the second blood vessel (e.g., femoral vein), through the filter 2724, due to a pressure gradient between the two blood vessels (blood pressure in the arteries is higher than blood pressure in the veins). In some embodiments, two or more of the operational modes may be combined.

[0193] Shown in Fig. 27C is an exploded view of filtering unit 2700. The filtering unit 2700 may include a filtering unit body 2726 accommodated with the casing 2702. The filtering unit body 2726 may include, for example, the inlet port 2708, the reservoir base 2714, etc. The filtering unit 2700 further includes the filter 2724. In some embodiments, the filter 2724 is positioned such that blood drawn from the blood vessel (e.g., carotid artery) is filtered as it is expelled out of the filtering unit and returned into the patient’s body. In some embodiments, the filter 2724 is positioned such that blood drawn from the blood vessel is filtered as it enters the filtering unit 2700, e.g., before it enters the reservoir. Also shown in Fig. 27C is member 2728, which includes the inner chamber (at least a portion thereof) and the first floating member, and member 2730, which includes the air vent chamber, the air vent and the second floating member.

[0194] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0195] As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.

[0196] Although the disclosure is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the disclosure embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.

[0197] The phraseology and terminology employed herein are for descriptive purposes and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

[0198] As used herein, the term “about” may be used to specify a value of a quantity or parameter (e.g., the length of an element) to within a continuous range of values in the neighborhood of (and including) a given (stated) value. According to some embodiments, “about” may specify the value of a parameter to be between 80 % and 120 % of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 90 % and 110 % of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 95 % and 105 % of the given value. In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

[0199] In the description and claims of the application the expression “at least one of A and B”, (e.g. wherein A and B are elements, method steps, claim limitations, etc.) is equivalent to “only A, only B, or both A and B”. In particular, the expressions “at least one of A and B”, “at least one of A or B”, “one or more of A and B”, and “one or more of A or B” are interchangeable.

[0200] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0201] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0202] Although steps of methods according to some embodiments may be described in a specific sequence, methods of the disclosure may include some or all of the described steps carried out in a different order. A method of the disclosure may include a few of the steps described or all of the steps described. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such.

[0203] The phraseology and terminology employed herein are for descriptive purposes and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

Claims

CLAIMSWhat is claimed is:

1. A closure device for deploying a suture on or around an opening in a blood vessel, the closure device comprising: a proximal portion and a distal portion, at least part of the distal portion being configured for positioning within the blood vessel; at least one suture deployment mechanism positioned at the distal portion of the closure device, the at least one suture deployment mechanism comprising: at least one anchoring element configured for reversible transition between a closed state and an open state, and configured, when in the open state, to secure the at least part of the distal portion of the closure device within the blood vessel and to facilitate passing of a suture therethrough; at least two suturing needles configured for reversible deployment from the distal portion of the closure device; and at least one snare needle comprising a snare portion configured for engagement with the suture; wherein the at least two suturing needles comprise at least one giver needle and at least one receiver needle, and wherein the at least one snare needle is configured for reversible deployment from the at least one receiver needle.

2. The closure device according to claim 1, wherein the at least one anchoring element is pivotally deployable.

3. The closure device according to either one of claims 1 or 2, wherein the at least one anchoring element comprises one or more internal passages, the one or more internal passages comprising a first internal passage configured to allow passing of the suture therethrough.

4. The closure device according to claim 3, wherein the snare needle is configured for passing through the first internal passage.

5. The closure device according to either one of claims 3 or 4, wherein passing the suture through the first internal passage comprises passing the snare needle through the first internal passage with the suture being engaged with the snare portion of the snare needle.

6. The closure device according to any one of claims 3 to 5, wherein the one or more internal passages comprises a second internal passage, and wherein the at least one giver needle is configured to pass through or within the second internal passage.

7. The closure device according to any one of claims 1 to 6, wherein the snare portion of the at least one snare needle is configured for passing the suture therethrough.

8. The closure device according to any one of claims 1 to 7, wherein the snare portion of the at least one snare needle comprises a pre-formed opening, and wherein the preformed opening is configured to open upon deployment of the snare needle from the at least one receiver needle.

9. The closure device according to any one of claims 1 to 8, comprising at least one grasper needle configured for reversible deployment from within the at least one giver needle, the grasper needle comprising a grasper portion configured to hold an end of the suture.

10. The closure device according to any one of claims 1 to 9, comprising a knot formed by winding the suture around the at least one receiver needle, and wherein the closure device is configured to deploy the knot together with the suture.

11. The closure device according to any one of claims 1 to 10, wherein the at least one anchoring element, when in the closed state, forms part of a wall of the distal portion of the closure device.

12. The closure device according to any one of claims 1 to 11, wherein at least one of the proximal portion of the closure device and a body portion of the closure device comprises a control handle.

13. The closure device according to any one of claims 1 to 12, wherein at least a distal end of the distal portion of the closure device is curved.

14. A method for deploying a suture on or around an opening in a blood vessel, the method comprising: inserting at least part of a distal portion of a closure device according to any one of claims 1 to 13 into the blood vessel; opening the at least one anchoring element within the blood vessel; deploying the at least two suturing needles from the distal portion of the closure device; deploying the at least one snare needle from the at least one receiver suturing needle; passing a first suture end from the at least one giver needle to the at least one snare needle; retracting the at least one snare needle into the at least one receiver needle to pull the first suture end therewith; retracting the at least two suturing needles into the distal portion of the closure device; closing the at least one anchoring element; and removing the at least part of the distal portion of the closure device from the blood vessel.

15. The method according to claim 14, comprising passing the at least one snare needle through the at least one anchoring element.

16. The method according to either one of claims 14 or 15, wherein passing a first suture end from the at least one giver needle to the at least one snare needle comprises deploying the at least one grasper needle from the giver needle and passing the at least one grasper needle through the snare portion of the snare needle, with the first suture end being engaged with a grasper portion of the grasper needle.

17. The method according to any one of claims 14 to 16, comprising deploying at least one securing member on the first suture end and a second suture end, wherein the at least one securing member comprises a pre-formed knot.

18. The method according to claim 17, comprising deploying a thrombogenic material on or together with the at least one securing member.

19. A kit for closing an opening in a blood vessel, the kit comprising at least one closure device according to any one of claims 1 to 13 and at least one suture cutter unit configured for cutting suture ends.

20. The kit according to claim 19, wherein the suture cutter unit is configured to accommodate therein and deploy therefrom a thrombogenic material.

21. The kit according to either one of claims 19 to 20, wherein the suture cutter unit comprises a cutter configured to facilitate the cutting of the suture ends.

22. A system for treating a blood vessel, the system comprising the closure device according to any one of claims 1-13, and one or more of: a reverse flow device, a suture cutter device and an access sheath.

23. The system according to claim 22, wherein the suture cutter unit comprises: a snare configured for passing suture ends therethrough; a deployable thrombogenic material; and a cutter configured to facilitate cutting of the suture ends.

24. The system according to either one of claims 22 or 23, wherein the reverse flow device comprises: a reservoir configured for receiving blood from a first blood vessel; a piston configured for movement within the reservoir; a piston rod coupled to the piston, the piston rod being threaded along at least a portion of its length; and a filtering unit comprising an inlet port configured for coupling to the first blood vessel, an outlet port configured for coupling to a second blood vessel, and a filter configured for filtering the blood received from the first blood vessel prior to its retrieval to the second blood vessel.

25. The system according to any one of claims 22 to 24, wherein the access sheath is a two-part access sheath comprising: a proximal part comprising: a first sealing port disposed at the proximal end of the proximal part; and at least a first portion of a connector disposed at the distal end of the proximal part; and a distal part reversibly connectable to the proximal part, the distal part comprising; a second sealing port disposed at the proximal end of the distal part; and at least one anchor disposed at or near the distal end of the distal part, the at least one anchor being configured for anchoring the distal part within the blood vessel.

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