Suture delivery devices and methods of use thereof

Abstract

A delivery device for suture deployment is disclosed. The delivery device comprises: a distal assembly comprising an elongate member; a proximal housing comprising one or more control elements for controlling one or more components of the delivery device; and a plurality of delivery tubes extending distally from the proximal housing into the elongate member. Each of the plurality of delivery tubes includes a suture anchor stored within a distal portion of the delivery tube, and a pushrod configured to urge the suture anchor distally from the distal portion of the delivery tube to deploy the suture anchor within target tissue.

Description

[0001] Priority Claim

[0002] This application claims priority to U.S. Provisional Application No. 63 / 424,747, filed on November 11, 2022. The disclosure of these priority applications is hereby incorporated by reference in its entirety. Field of the Invention

[0003] The present disclosure generally relates to devices and methods for percutaneous access to a blood vessel lumen and subsequent closure of the access site into the blood vessel. Background Art

[0004] Healthcare providers often use sutures to close various openings, such as cuts, stabs, wounds, incisions, or to join tissues of various parts of the body. Generally, sutures are convenient to use and can effectively close biological tissue openings, thereby promoting blood clotting, healing, and preventing scar formation.

[0005] For example, in many interventional procedures, interventional devices are introduced through a patient's artery or vein (percutaneous access). For example, in the treatment of vascular diseases such as arteriosclerosis, it is common practice to access the artery and insert an instrument (e.g., a balloon or other type of catheter) to perform a procedure within the artery. Such procedures typically involve percutaneous puncture of the artery in order to place an insertion sheath into the artery, and then the instrument (e.g., a catheter) is passed through the sheath and into the surgical position within the vascular system. While these procedures have various medical advantages, the possibility of bleeding during the procedure can pose a danger to the patient. In addition, after a particular interventional procedure, the puncture hole in the vessel wall must be closed. A variety of prior vascular closure devices and methods have been developed in an attempt to provide solutions to the problem of closing the holes in the vessel wall.

[0006] In some cases, a medical suture system "pre-closes" the access site or perforation in the vessel wall by positioning one or more sutures near the interventional device, thereby stopping bleeding during the procedure. After the procedure is completed and the interventional device is removed, the sutures positioned by the medical suture system can be used to permanently or reversibly (e.g., for reinsertion of the interventional device) close the access site. Interventional procedures typically employ minimally invasive methods and / or percutaneous procedures and cannot be directly observed. Due to the inability to directly observe, deploying sutures using traditional sutures and suture systems has become challenging in such procedures.

[0007] The present disclosure describes devices and methods designed to address some of the above problems. Summary of the Invention

[0008] A delivery device for suture deployment is disclosed. The delivery device may include: a distal assembly including an elongate member; a proximal housing including one or more control elements for controlling one or more components of the delivery device; and a plurality of delivery tubes extending distally from the proximal housing to the elongate member. Each of the plurality of delivery tubes may include: a suture anchor stored within a distal portion of the delivery tube; and a pusher configured to push the suture anchor distally from the distal portion of the delivery tube for deploying the suture anchor into a target tissue. A sheath may be removably mounted over at least a distal portion of the elongate member.

[0009] Optionally, a guide wire lumen may extend between a distal end and a proximal end of the delivery device.

[0010] In various embodiments, the delivery device may include a blood return channel extending between a distal port disposed within the distal assembly and a proximal port disposed within the proximal housing. The blood return channel may be configured to provide an indication of proper positioning of the distal assembly within the target tissue based on the presence of blood within the proximal port. Optionally, the blood return channel may be a passage defined by an inner guide wire lumen and an outer tube.

[0011] In certain embodiments, the distal assembly may include a dilator and a stabilizer. Optionally, the stabilizer may be disposed between the dilator and the elongate member, and / or in an undeployed state, the diameter of the stabilizer may be substantially similar to the diameter of the dilator. Additionally and / or alternatively, distal movement of the outer tube within the elongate member may cause deployment of the stabilizer for temporarily fixing the delivery device at a location within the target tissue for proper positioning of the suture anchor upon deployment. The proximal housing may include an actuation mechanism for controlling distal movement of the outer tube to deploy the stabilizer. The stabilizer may be a cylindrical nitinol mesh configured to form a generally disc shape upon deployment of the stabilizer.

[0012] Additionally and / or alternatively, the dilator may be made of a soft material and configured to enlarge an initial puncture opening. The length of the dilator may be from about 0.5 inches to about 1 inch.

[0013] In various embodiments, the elongate member may include a proximal tubular portion and a distal tapered portion. The distal tapered portion may include a plurality of guiding features configured to position the plurality of delivery tubes in a desired configuration upon deployment. Each of the plurality of guiding features may include a generally semi-circular groove configured to receive and guide a delivery tube.

[0014] The passageway can extend from the distal end of the elongate member to the proximal housing. The passageway can be configured to receive a guidewire lumen, a plurality of delivery tubes, and an outer tube configured to define a blood return channel. Each delivery tube can include an elongate tubular member extending distally from a delivery tube retainer in the proximal housing into the passageway. A pusher can extend distally from a pusher retainer in the proximal housing into the lumen of each delivery tube. Optionally, the proximal housing can include a rack and pinion control mechanism configured to be actuated by a flip handle such that rotation of the flip handle causes the delivery tube retainer and the pusher retainer to be advanced distally. Additionally and / or alternatively, the delivery device can include an elastic member configured to stop the distal movement of the delivery tube retainer when in a fully compressed state. Thus, when the distal movement of the delivery tube retainer stops, the distal movement of the pusher retainer causes the pusher to deploy a suture anchor inside the target tissue by pushing the suture anchor out of the distal end of the delivery tube.

[0015] In various embodiments, each of the plurality of delivery tubes is disposed in the passageway so as to radially surround the guidewire lumen at a desired spacing. The delivery tube can include a distal portion that flares outward relative to the passageway upon deployment. Positioning elements disposed within the passageway can be configured to flare the plurality of delivery tubes.

[0016] Optionally, each of the plurality of delivery tubes can include a slot for receiving the distal end of a suture, the distal end of the suture being coupled to the suture anchor.

[0017] In some embodiments, the delivery device can include four delivery tubes.

[0018] The length of one or more of the plurality of delivery tubes can be different from the lengths of the other delivery tubes in the plurality of delivery tubes.

[0019] In various cases, a method of deploying a suture using the above-described delivery device can include advancing the distal end of the delivery device into the target tissue, deploying a stabilizer after observing blood return, advancing the plurality of delivery tubes distally into the target tissue, and, when it is detected that the plurality of delivery tubes have reached a maximum advancement position, advancing each pusher distally into the lumen of that delivery tube to cause deployment of that suture anchor.

[0020] In some other cases, a suture delivery device for suture deployment is disclosed. The delivery device may include an outer tube concentrically disposed around a guide wire lumen to form a blood return channel outside the guide wire lumen, and a passage defined by the delivery device. The passage is configured to accommodate the outer tube and a plurality of delivery tubes. The plurality of delivery tubes may extend distally from a delivery tube holder. Each delivery tube may include a suture anchor stored within a distal portion of the delivery tube, and a push rod extending from a push rod, the push rod being configured to push the suture anchor distally from the distal portion of the delivery tube for deploying the suture anchor into a target tissue. The delivery device may further include an elastic member configured to stop the distal movement of the delivery tube holder when in a fully compressed state. When the distal movement of the delivery tube holder stops, the distal movement of the push rod holder may cause deployment of the suture anchor within the target tissue via the push rod.

[0021] In various embodiments, the delivery device may include a control mechanism configured to advance the delivery tube holder and the push rod holder distally.

[0022] In various cases, a method of deploying a suture using a suture delivery device may include advancing a distal end of the suture delivery device into a target tissue, deploying a stabilizer of the suture delivery device after observing blood return, advancing a plurality of delivery tubes distally into the target tissue, each delivery tube including a suture anchor and a push rod, and when it is detected that the plurality of delivery tubes have reached a maximum advancement position, advancing each push rod distally into the lumen of the delivery tube to cause deployment of the suture anchor. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1A is a perspective view of an exemplary delivery device.

[0024] Figure 1B is Figure 1A a top view of the delivery device of

[0025] Figure 1C is Figure 1A a bottom view of the delivery device of

[0026] Figure 1D is Figure 1A an exploded view of the delivery device of

[0027] Figure 1E is Figure 1A a cross-sectional view of the delivery device of

[0028] Figure 2A is a schematic view showing deployment of an exemplary stabilizer.

[0029] Figure 2B is a schematic view showing deployment of another exemplary stabilizer.

[0030] Figure 3A is Figure 1A an enlarged view of an elongate member of a delivery device of Figure 3B is a cross-sectional view of the elongate member taken along the YZ plane.

[0031] Figure 4A is Figure 3A an enlarged front perspective view of a tapered portion of the elongate member of

[0032] Figure 4B shows a sectional view of the tapered portion with a delivery tube.

[0033] Figure 4C shows a sectional view of the tapered portion without a delivery tube.

[0034] Figure 4D shows a delivery tube without a tapered portion.

[0035] Figure 5 shows an exemplary positioning element.

[0036] Figures 6A to 6E displays various types of suture anchors.

[0037] Figure 7 is a schematic diagram of delivery tubes of unequal lengths deployed within a target tissue.

[0038] Figures 8A to 8C respectively show Figure 1A cross-sectional views of the device housing in a neutral position, a deployed position, and a retracted position in

[0039] Figure 9 shows a suture anchor stored within the distal end of a delivery tube.

[0040] Figure 10 is a flowchart showing an exemplary method of deploying a suture using the delivery device of the present disclosure.

[0041] Figure 11A is Figure 9 a schematic diagram of a part of an exemplary method of

[0042] Figure 11B is Figure 9 a schematic diagram of a part of an exemplary method of

[0043] Figure 11C is Figure 9 a schematic diagram of a part of an exemplary method of

[0044] Figure 11D is Figure 9 a schematic diagram of a part of an exemplary method of DETAILED DESCRIPTION

[0045] The apparatus and method of the present disclosure can be more easily understood by referring to the following detailed description of embodiments in conjunction with the accompanying drawings, which form a part of the present disclosure. It should be understood that the present application is not limited to the specific apparatus, method, conditions or parameters described and / or shown herein, and the terms used herein are for illustrative purposes only and are not intended to be limiting. In some embodiments, as used in the specification (including the appended claims), the singular forms "a", "an" and "the" include the plural, and a reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and / or to "about" or "approximately" another particular value. When expressing such a range, another embodiment includes from one particular value and / or to another particular value. Similarly, when a numerical value is expressed as an approximation using the antecedent "about", it should be understood that the particular value constitutes another embodiment. It should also be understood that all spatial references, e.g., proximal, distal, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and may vary within the scope of the present disclosure. For example, "upper" and "lower" are relative and are used only in context and are not necessarily "above" and "below".

[0046] As used herein, the terms "proximal" and "distal" refer to the location where the operator manipulates the delivery device. As used herein, the term "proximal" refers to the closest to the operator (less into the body), while "distal" refers to the farthest from the operator (more into the body).

[0047] As used herein, the term "suture" may be a single or multifilament elongated flexible tensioning device made of flexible or non-flexible material, having sufficient tensile strength to provide the required force. Sutures may be strands, wires, cords, fibers, yarns, filaments, cables, threads, etc., and these terms may be used interchangeably. Suture materials are generally classified into two categories: absorbable (able to decompose and be absorbed by the body) and non-absorbable (should be manually removed from the body). Exemplary materials include, but are not limited to, polyglycolic acid, polylactic acid (PLA), polypropylene, polyester, silicone, polyurethane, stainless steel, nitinol, nylon, Kevlar fibers, etc.

[0048] As used herein, the terms "closure", "closing", "shutting" refer to reducing the size (e.g., diameter, area, volume, etc.) of an opening in a biological structure (e.g., a blood vessel) from an initial size to a smaller size. The opening may be a naturally formed aperture or passageway, or a surgically formed aperture or passageway. "Entry site" refers to an opening formed surgically in a biological structure, e.g., for an interventional procedure.

[0049] The present disclosure relates to suture deployment methods and systems for closing an opening (e.g., by tightening). While the examples provided in this disclosure generally relate to suture delivery devices (or "delivery devices") for percutaneous management of vascular access sites (i.e., intravascular), the disclosed systems and methods can also be used to deliver or deploy sutures to other access sites or openings, such as, but not limited to, access sites or openings in various visceral organs. For example, the disclosed embodiments can be used to manage access sites or openings in the heart (e.g., inside or outside the heart) or in the gastrointestinal tract. For example, the suture delivery device of the present disclosure can be used to deploy sutures for treating an anatomical valve (e.g., a heart valve), including a heart valve that may be weakened or stretched, or have other structural defects (e.g., congenital defects) that result in improper closure. The suture system includes a suture delivery device for deploying sutures, which can be used to close or reduce various other tissue openings, cavities, hollow organs, or natural or surgically created passages in the body. Specifically, a delivery system for delivering or deploying sutures to close various openings is described herein.

[0050] The delivery system of the present disclosure can be used to deploy sutures to close an opening (e.g., by tightening when the suture is tensioned), using, for example, the closure systems and devices described in U.S. Patent No. 11,382,609, U.S. Patent Application Publication No. 20220175356, U.S. Patent Application Publication No. 20230149005, and U.S. Patent Application Publication No. 20230309979, the disclosures of which are incorporated herein by reference in their entireties. The delivery system of the present disclosure can be used with any currently or future-known suture systems and closure devices.

[0051] In some embodiments, the present disclosure relates to suture deployment methods and devices for "pre-closing" an opening (e.g., a blood vessel, a heart valve, etc.). For example, these methods and devices can be used to deploy sutures to close an access site in a blood vessel, where the suture is applied before using an interventional device (e.g., a sheath or cannula) to access the blood vessel.

[0052] In some cases, a micro-puncture technique is used, where a small needle is first inserted into the blood vessel and then gradually dilated to the size of the puncture device. For percutaneous puncture, it is through the skin, through the subcutaneous tissue layer to reach the blood vessel and finally into the blood vessel itself. In certain types of surgeries, "pre-closure" of the access site is beneficial, for example, if the access site is large, if the access site is difficult to access or if the risk of accidental removal of the sheath is high. "Suture pre-closure" refers to deploying sutures before using an interventional device to access the blood vessel. The ability to quickly control hemostasis at the access site is crucial. In open surgery, sometimes sutures are placed in the blood vessel wall in a U-stitch, Z-stitch or purse-string needle pattern before accessing the blood vessel. The access site is made through the center of this suture pattern. During the surgery, the sutures may be tightened around the interventional device or the sutures may remain loose. If the interventional device is accidentally removed from the access site, rapid hemostasis can be achieved by applying tension to the ends of the sutures. After removing the interventional device from the arteriotomy, the sutures can be appropriately manipulated to achieve reversible and / or permanent homeostasis.

[0053] In percutaneous surgery, sutures cannot be inserted in the above manner. In these surgeries, if suture pre-closure is required, a percutaneous suture-based vascular closure device needs to be used. However, current percutaneous suture-based vascular closure devices require pre-dilation (widening) of the initial needle puncture or access site in order to insert into the blood vessel and are designed to be placed after the interventional device is inserted (and in some cases removed from the access site). In this way, the dilation is done by the interventional device and the dilator itself. Given this, current suture-based vascular closure devices have certain limitations in terms of being used for access site pre-closure. To use these devices for pre-closure, a dilator or dilator / sheath combination needs to be inserted into the blood vessel through a guide wire to dilate the initial puncture point first and then the closure device is replaced, and it is difficult to maintain hemostasis during the replacement process.

[0054] Another limitation is that once the sutures are placed in the blood vessel using a suture-based vascular closure device, it is equally difficult to maintain hemostasis during the removal of the suture-based vascular closure device and the insertion of the interventional device. Similarly, once the interventional device is removed, it is also difficult to maintain hemostasis before tying the last suture knot. Or, if the sutures are pre-tied, it is also difficult to maintain hemostasis before pushing the knot into place. In addition, current suture-based vascular closure devices do not have any way to quickly access the ends of the sutures in order to apply tension in the case of accidental removal of the interventional device.

[0055] Certain procedures, such as, for example, carotid interventions, present additional clinical challenges. When treating the internal carotid artery and / or carotid bifurcation via a trans-cervical approach, the distance from the access site to the treatment site is typically less than 5 - 7 centimeters. For Abbott PROSTAR or PERCLOSE suture-based closure devices, the vascular access device needs to be inserted into the vessel approximately 15 centimeters to retrieve the guidewire. Other devices lack a means or function to limit or control the outflow of these device components within the vessel. Accordingly, there is a need to limit the length of the suture delivery device or any associated accessories (needle puncture device, guidewire, micro-guide, dilator, or the sheath itself) to eliminate the risk of invading the plaque area and to reduce the risk of generating embolic particles.

[0056] The devices and methods disclosed herein are directed to improving at least one of the above problems. However, it should be understood that the disclosure herein is not limited to solving these particular problems. Additionally, while the devices and techniques disclosed herein are described with respect to the human body or patient, it should be understood that these devices and techniques may also be applied to non-human patients (e.g., in veterinary medicine) where appropriate.

[0057] In various embodiments, the present disclosure describes a suture delivery device that can dilate an initial access site (e.g., a needle puncture), thus obviating the need for prior dilation using a separate device or surgical sheath dilator. The suture delivery device can place, anchor, or otherwise deploy one or more sutures near the access site for subsequent tightening of the access site (around an intervention device or other device) using a closure device to effect hemostasis of the access site. Although the devices discussed herein are directed to promoting hemostasis, the devices and methods disclosed herein can be used for other applications to achieve different results, e.g., for managing access sites to the heart or gastrointestinal tract. Similarly, the suture delivery device of the present disclosure can place, anchor, or otherwise deploy one or more sutures near any opening for subsequent tightening of the opening using a closure device. For example, the anchors and sutures of current puncture and closure devices can be deployed near and / or around a cardiac opening.

[0058] The disclosed suture device limits the length of the suture delivery device (or any associated accessories) inserted into the vessel to between approximately 0.5 inches and approximately 1.5 inches, between approximately 0.75 inches and approximately 1.25 inches. Optionally, during suture deployment, the suture is in a relaxed state (i.e., not under tension) to avoid cutting the suture during insertion of the intervention device. After insertion of the intervention device, the suture is tensioned.

[0059] Accordingly, the devices of the present disclosure can reduce the resources (e.g., personnel time, materials, etc.) used to control or substantially eliminate bleeding / effusion / effused fluid. The devices are available for use by a variety of populations to quickly stop leaks and / or promote wound healing. Aspects of the present disclosure can be used percutaneously (i.e., without direct user observation). However, it should be understood that the devices and methods described herein can also be used under direct user observation or under indirect observation by using, for example, a surgical endoscope.

[0060] Reference is now made to the drawings, and in particular Figures 1A to 1E to, in which an exemplary suture delivery device 100 is shown and described.

[0061] The suture delivery device 100 generally includes a distal assembly 101 and a proximal housing 102 having control elements or actuators (e.g., such as a movable actuator rod 127 and / or an actuator button 122) and a control mechanism configured to control one or more components of the delivery device. The type, number, and shape of the control elements can vary. The movable actuator rod 127 is a flip handle that controls the movement of the suture delivery tube and the pusher to deploy the suture through a suture anchor (described below). As described below, the actuator button 122 controls the deployment of the stabilizer. Optionally, the housing 102 can include one or more interface elements (not shown here), such as clips, protrusions, slots, etc., provided on the housing body, for detachably connecting a closure device (e.g., a tensioning device) or its components.

[0062] A continuous guidewire lumen 103 is provided within the device 100 between the distal tip 110 and the proximal tip 120 for tracking the suture delivery device 100 throughout a guidewire (not shown). Optionally, the guidewire lumen can extend between the proximal tip 120 and the proximal end of the dilator 111 such that the dilator lumen is adjacent to the guidewire lumen. The distal exit of the guidewire lumen 103 smoothly transitions to the guidewire, so that the device can be smoothly inserted through the guidewire opening. Accordingly, the diameter of the guidewire lumen 103 can be close to the diameter of the guidewire when it exits the distal tip 110. For example, to be compatible with a 0.035-inch or 0.038-inch guidewire, the distal tip of the device can have a guidewire lumen from 0.039 inches to 0.041 inches when exiting the tip (although for the remainder of the device, the lumen can be slightly larger). Although the present disclosure describes the guidewire lumen as extending along the entire length of the delivery device such that the guidewire can travel along the entire length of the delivery device and exit from the proximal end, it is not limited thereto. The guidewire can exit from a point on the delivery device that is remote from the proximal tip 120. As described below, the suture delivery device allows for the deployment of the suture without removing the guidewire.

[0063] A blood return channel 104 is provided with a distal port 141(a) within the distal assembly (as Figure 2A and Figure 2Bshown) and the proximal port 141(b) within the proximal housing (such as Figure 1E shown). The distal port 141(a) of the blood return channel 104 is positioned relative to and / or proximal to the stabilizer 112 such that when the stabilizer 112 is properly positioned within the blood vessel (e.g., fully within the blood vessel), blood pressure causes blood to flow proximally into the distal port 141(a), through the blood return channel 104, and to the proximal port 141(b) within the proximal housing 102. The presence of blood in the proximal port 141(b) indicates that the stabilizer 112 has entered the blood vessel and it can be actuated to the "open" position (described below). The proximal port 141(b) can include a blood outlet, a transparent tube or container for visible blood, etc. It should be understood that various alternative sensors can be used, including voltage sensors, electrolyte detectors, etc., for determining the correct position of the stabilizer within the blood vessel. In some embodiments, the blood return channel 104 can be a passageway concentrically disposed around at least a portion of the guide wire lumen such that blood flows in the space outside the guide wire lumen wall and inside an outer tube 105 concentrically disposed around the guide wire lumen. For example, Figure 2B shows the outer tube 105, which is disposed around the guide wire lumen 103 to define the blood return channel 104. Optionally, a separate tube can be provided for the blood return channel.

[0064] In various embodiments, the distal assembly 101 includes a dilator 111, a stabilizer 112, and an elongate member 113. A detachable sheath 114 is mounted on the elongate member 113 and configured to cover at least the proximal portion of the elongate member 113. In various embodiments, the sheath 114 can be configured to cover the delivery tube prior to deployment to prevent blockage of the delivery tube (e.g., by tissue, blood clots, etc.) when the delivery device is advanced within the opening to deploy the suture. The sheath can be removed by manual peeling and / or (manually or mechanically) retracting prior to deploying the suture. The sheath can be made of any suitable material, such as, but not limited to, polytetrafluoroethylene (PTFE), silicone, rubber, polyurethane, polyethylene, etc., and can fit tightly to the shape and dimensions of the elongate member 113.

[0065] In various embodiments, the dilator 111 is made of a soft material and is configured to enlarge or expand an initial puncture (e.g., made using a needle) made by a surgeon to access a blood vessel or other opening that needs to be sutured. The dilator is configured to allow a delivery device to be easily inserted into soft tissue and / or through a target tissue (e.g., a blood vessel wall or a septal wall). In this regard, the dilator has features (e.g., including dimensions, shape, material, and / or material properties) that are particularly suitable for dilating a particular opening. For example, when the dilator 111 is configured to expand an initial puncture in a blood vessel when the delivery device enters the blood vessel, the dilator is made of a particular material and is sized to expand the initial puncture within the blood vessel. In various embodiments, the length of the dilator is about 0.5 inches to about 1.5 inches, about 0.75 inches to about 1.25 inches, about 0.5 inches, about 0.75 inches, about 1 inch, about 1.25 inches, about 1.5 inches, about 2 inches, etc. As described above, the length of the dilator is significantly less than that of existing suture delivery devices because the delivery device of the present disclosure does not require removal of a guide wire during suture deployment. Thus, the dilator does not need to have a certain length to provide support for an existing delivery device after removal of the guide wire, which is required for existing delivery devices during suture deployment.

[0066] In various embodiments, the dilator 111 is made of a soft material, such as, for example, polyurethane, polyester, a polymer family / class (e.g., polyamides, including nylon and polyether block amide (PEBAX - 72D)), etc. The soft material allows the dilator to bend when deployed inside a blood vessel. Additionally, the dilator may have a tapered distal portion so that there is no abrupt transition when the dilator enters the opening over a guide wire. For example, the leading edge of the distal dilator tip (i.e., the distal tip 110) may be rounded, e.g., with a radius of 0.050 inches to 0.075 inches, to be compatible with an example 0.035 - inch or 0.038 - inch guide wire and may taper to a slightly larger radius, about 0.080 to about 0.1 inches.

[0067] A stabilizer 112 is provided and is located between the proximal end of the dilator 111 and the distal end of the outer tube 105 and docks with them by a friction fit or other suitable connection to provide a positioning reference for suture deployment. In an undeployed or contracted state, the diameter of the stabilizer 112 is substantially similar (or slightly smaller) to the diameter of the dilator 111. In some embodiments, the distal end of the stabilizer is at least partially inserted within the proximal end of the dilator 111. As described above and as shown in Figure 2A and Figure 2BAs shown, the distal port 141(a) of the blood return channel 104 is positioned relative to and / or near the stabilizer 112 such that blood return indicates the current position of the stabilizer 112. Specifically, the distal port may be within a threshold distance of the proximal end of the stabilizer such that the entire length of the stabilizer 112 passes through the target tissue (e.g., blood vessel wall or heart septal wall) where the suture is to be deployed. After observing blood return, the stabilizer 112 can be deployed by expanding the stabilizer diameter such that in the deployed or expanded state, the stabilizer abuts against the target tissue, thereby temporarily fixing the delivery device at the position where the suture will be correctly positioned after deployment. The expansion of the stabilizer near or against the target tissue prevents unnecessary movement and / or dragging of the stabilizer within the blood vessel (or organ), thereby reducing the risk of damaging the blood vessel wall while also minimizing the length of the dilator.

[0068] In an exemplary embodiment, as Figure 2A shown, the stabilizer comprises a cylindrical mesh made of a suitable material (e.g., nitinol, stainless steel, plastic, or any combination thereof) that expands outwardly (i.e., laterally with respect to the central axis of the delivery device) upon deployment to form a generally disc shape, the longitudinal length of which is less than the longitudinal length of the cylindrical mesh in the contracted state. Optionally, in addition to the anchoring and precise positioning functions, this configuration of the stabilizer can also prevent debris or particles (e.g., tissue, blood clots, etc.) from getting stuck within the stabilizer as it moves from the contracted state to the expanded state (or vice versa).

[0069] Figure 2B Another exemplary stabilizer is shown that includes two arms having a substantially semi-circular profile that are disposed around a guide wire lumen such that it is cylindrical in the contracted state. Upon deployment, the arms can expand outwardly (i.e., laterally with respect to the central axis of the delivery device) to form a generally disc shape (or dish-shaped, diamond-shaped, etc.), the longitudinal length of which is less than the longitudinal length of the cylindrical mesh in the contracted state.

[0070] Optionally, the stabilizer can be coated and / or wrapped in a suitable polymeric material, e.g., Chronoprene, silicone, PUR, PET, etc., in order to provide additional protection to the blood vessel wall or other target tissue. Additionally, the coating can be selected to prevent blood from passing through the stabilizer into the blood return channel, thereby preventing false signals. For example, as Figure 2B shown, the stabilizer 112 is wrapped in a polymer 190 to prevent blood from flowing into the blood return channel between the arms of the stabilizer.

[0071] Without limiting the present disclosure, the stabilizer can be any symmetric or asymmetric stabilizer known now or in the future, such as, but not limited to, a balloon, a stent, an intervertebral disc, a sheath that can expand from a contracted state after deployment, a shape memory (e.g., nitinol) mesh that can be transformed into an intervertebral disc in a deployed state, a polymer arm configured to be symmetrically and / or asymmetrically folded along the longitudinal axis (in a contracted state) or transversely (after deployment) of a delivery device, a shape memory (e.g., nitinol) arm configured to be cylindrical (in a contracted state) or reversibly folded after deployment to create a pattern (e.g., an "X" shape) to create an anchor for the target tissue, etc.

[0072] In various embodiments, the stabilizer 112 can be deployed by moving the outer tube 105 distally such that the distal end of the elongate member pushes against the proximal end of the stabilizer 112, thereby shortening or compressing the axial length (longitudinal) of the stabilizer and causing the stabilizer to expand in the transverse direction (e.g., bend outward as shown in FIG. 2). For example, the outer tube can be directly or indirectly coupled to a control element (e.g., the actuation button 122 in the housing 102) such that a user can slide, rotate, press, or otherwise manipulate the actuation button 122, causing the outer tube 105 (through any suitable linkage - not shown here) to move distally, thereby pushing against the proximal end of the stabilizer 112. Although the control element is illustrated as the actuation button 122, the present disclosure is not so limited, and other types of control elements are also within the scope of the present disclosure. Similarly, the proximal movement of the outer tube 105 can be achieved by the actuator 122 (e.g., by rotating or sliding in the opposite direction) to cause the stabilizer to contract or be undeployed.

[0073] Optionally, the distal movement of the outer tube can cause the sheath 114 to retract proximally automatically. For example, although not shown in the figures, the distal movement of the outer tube can cause an elastic member (e.g., a spring) to be released from a compressed state, causing the sheath to retract proximally (wherein the sheath is configured to be held in an initial state by a compressed elastic spring and is sleeved on the distal end of the elongate member).

[0074] Review Figures 1A to 1E And Figure 3A , the elongate member 113 includes a proximal tubular portion 131 and a distal tapered portion 132. The elongate member 113 defines a passageway or lumen 135 for accommodating (but not limited to) a guidewire lumen, an outer tube, a blood return channel, and a plurality of delivery tubes 133(a)–(d) (collectively 133), which are configured for deploying suture anchors. It should be noted that the passageway 135 and the outer tube 105 extend within the housing 102. Figure 3BA cross-sectional view of the passageway 135 (along the yz plane) is shown. Any number of delivery tubes can be included without departing from the principles of the present disclosure. It should be noted that although the present disclosure describes the proximal tubular portion 131 as having a cylindrical profile, other profiles or shapes (e.g., square, triangular, pentagonal, etc.) are also within the scope of the present disclosure.

[0075] In various embodiments, the distal tapered portion 132 is configured to provide a tapered distal end or tip to the elongate member 113 to facilitate insertion into the target tissue when the delivery device is in the distal position. As Figures 4A to 4C shown, the tapered portion 132 can be configured to include one or more guiding elements or features 134(a)-(d) (e.g., the semi-circular grooves shown in the figure) for receiving the delivery tubes in a desired configuration relative to the guide wire lumen 103. Other types of guiding features, e.g., (but not limited to) channels, ramps, etc., are also within the scope of the present disclosure. In certain embodiments, the tapered portion 132 can also include interface elements (e.g., slots) for detachably connecting a suture system, e.g., a suture tensioning device, a closure device, etc. or components thereof (e.g., suture locks), which suture systems can be disposed within the passageway 135.

[0076] Each delivery tube 133(a)-(d) is a rigid elongate tubular member that extends distally in the passageway 135 from a delivery tube retainer 124 within the housing 102 to the tapered portion 132. Each delivery tube defines a lumen extending between its proximal and distal ends. The cross-sectional shape of the delivery tube can be circular, square, etc.

[0077] In the neutral position, the distal ends of the delivery tubes 133(a)-(d) are configured to be at least a first threshold distance from the stabilizer and are stored in the tapered portion 132 in a desired configuration, around the guide wire lumen (e.g., using the guiding features 134(a)-(d)). For example, the delivery tubes 133(a)-(d) can be configured to radially surround the guide wire lumen 103 at a desired spacing. The first threshold distance can be determined such that the delivery tubes can be easily inserted into the target tissue, the stabilizer can be deployed without interruption, and / or blood reflux can be confirmed without interruption.

[0078] The configuration of the delivery tubes is designed based on the desired configuration of the suture anchor relative to the guide wire and / or when deployed through the opening. Optionally, if it is desired to minimize the size of the delivery device, the delivery tubes can be arranged around the guide wire lumen in a collapsed state and then expanded to the desired shape when ejected from the tapered portion 132. For example, in some embodiments, each delivery tube can include a distal portion that flares out (or bends outwardly) relative to the longitudinal axis of the delivery tube tubular body (as Figure 4Bas shown), but stored in the elongated member 102 in a contracted state. When such a bent delivery tube is pushed out of the tapered portion 132, the bent distal portion expands, allowing the delivery tube and the suture anchor to leave an appropriate spacing relative to the guide wire and / or the opening. In some other examples, the guiding elements 134(a)-(d) can be configured to bring the delivery tube to its desired shape. For example, the guiding feature can be a small ramp to push the anchor delivery tube outward to an appropriate distance from the guide wire lumen.

[0079] In another example, the delivery tube is brought to its target configuration by advancing a positioning element 180 (such as Figure 5 as shown) within the elongated member 102. The anchor delivery tube in this example can be pre-bent or laser cut into a certain shape so that it can be bent into a specific shape by the positioning element. In such embodiments, the positioning element 180 can be advanced within the passageway 135, located between the spaces defined by the delivery tube. When the positioning element 180 expands, the delivery tubes 133(a)-(d) bend or flex outward from the initial state 501 to the bent state 502 (such as Figure 5 as shown). The positioning element can be separated from or integrated with any part of the device 100. They can be detachably or fixedly mounted on the guide wire, the device, and / or its components and / or other devices. Before deploying the suture anchor, the expansion of the positioning element 180 can be selectively controlled to control the positioning of the delivery tubes 133(a)-(d) relative to the opening (and thus control the position of the suture), without increasing the footprint of the delivery device itself. The positioning element can be, for example, an inflatable balloon, a disc, a cage, a ball, a net, a stent, or other structures that are in a first compressed state to be advanced within the passageway into the space between the delivery tubes and can assume a second expanded state to bend the delivery tubes outward.

[0080] After the stabilizer is deployed, the delivery tube can be pushed distally out of the distal end of the tapered portion 132 (in the desired configuration as described above) and advanced toward the stabilizer until the distal ends of the delivery tubes 133(a)-(d) reach a second threshold distance from the deployed stabilizer. The determination of the second threshold distance should allow the stabilizer to control the precise positioning of the delivery tube relative to the opening to facilitate the deployment of the suture. Optionally, to ensure that the anchor is deployed in the target tissue, the delivery tube can be advanced an appropriate distance past the stabilizer located on the other side of the target tissue. Since the anchor delivery tube may pass through soft tissue (e.g., subcutaneous tissue) to deploy the anchored suture on the blood vessel wall, the distal end of the delivery tube can have an appropriate profile (e.g., beveled edge, shaped edge) to facilitate the delivery tube passing through the soft tissue.

[0081] Optionally, as Figure 4B and Figure 4DAs shown, each delivery tube 133(a)-(d) includes a longitudinal slot 137 that extends along the longitudinal length of the delivery tube from the respective distal end (the slot may not extend along the entire length of the delivery tube). Optionally, the slot 137 may be an opening or hole formed in one side of the delivery tube that does not extend to the distal end of the delivery tube. Optionally, the slot may be provided in the portion of the delivery tube facing the guide wire lumen (e.g., when the tensioning tube is stored within the tapered portion 132). However, the slot may also be provided in any portion of the delivery tube (e.g., a portion away from the guide wire lumen). As shown. As Figure 9 As shown, in various embodiments, the distal end of the suture 150 may be connected to the suture anchor 160 and stored within the distal end of the delivery tubes 133(a)-(d), while the proximal end of the suture 150 exits the delivery tube through the respective slot (one suture per delivery tube) and engages with the suture system 900 (e.g., closure device, tensioning tube, etc.). The distal end of the suture 150 connected to the suture anchor 160 may be deployed through the distal end of the delivery tubes 133(a)-(d).

[0082] The delivery tubes 133(a)-(d) may be advanced within the passageway 135 and out of the tapered portion 132 such that the distal end of each delivery tube may be positioned in the tissue region (e.g., within the vessel wall) and / or near or within a structure surrounding the opening to be closed for subsequent deployment, desired positioning, and anchoring of the distal end of the suture around the opening (as described below). In various embodiments, the lengths of the delivery tubes may be configured such that their respective distal ends reach the target tissue simultaneously. Thus, if the delivery device is advanced at an angle (non-90°) relative to the target tissue, the lengths of the delivery tubes may be different from each other to ensure that each delivery tube reaches the target tissue simultaneously. For example, Figure 7 Delivery tubes 133(a)-(d) of unequal lengths are shown such that they reach and / or insert into the target tissue 200 simultaneously.

[0083] In some embodiments, the size of the delivery tube varies depending on the size of the suture anchor used. In some examples, the outer diameter (OD) of the delivery tube is about 0.030 inches, about 0.032 inches, about 0.033 inches, about 0.034 inches, about 0.035 inches, about 0.037 inches, about 0.040 inches, etc.; the inner diameter (ID) is about 0.023 inches, about 0.025 inches, about 0.026 inches, about 0.027 inches, about 0.029 inches, about 0.030 inches, etc. In some other examples, the OD of the anchor delivery tube is about 0.030 inches to 0.040 inches, about 0.032 inches to 0.038 inches, about 0.034 inches to 0.036 inches, etc.; the ID is about 0.020 inches to 0.030 inches, about 0.022 inches to 0.028 inches, about 0.024 inches to 0.026 inches, etc. The inner and outer diameters of the delivery tube may vary depending on the size of the suture anchor disposed within the delivery tube, the size / diameter of the outer tube, the diameter of the passageway, the size of the opening, etc.

[0084] In addition, the present disclosure shows four delivery tubes 133 (a)-(d), but this is for illustrative purposes only. The exact number and spacing of the delivery tubes can be determined based on the specific application. It is foreseeable that the larger the opening, the greater the number of sutures, and therefore the greater the number of delivery tubes required. In some applications, the number of sutures may also depend on, for example, the force required to draw the tissue around the opening, the location of the opening, the type of opening, the shape of the opening, etc. With respect to spacing, the delivery tubes can be evenly distributed (e.g., radially around the guidewire lumen) and / or unevenly distributed within the passage 135.

[0085] Various forms of suture anchors are described in more detail below. In various embodiments, when the suture anchor 160 is located in the corresponding delivery tube 133, it is configured to be in a first compressed state so as to be moved within the delivery lumen and inserted into the tissue. Once inserted or deployed into the tissue, the suture anchor 160 will open or expand and anchor the distal end of the corresponding suture to the tissue.

[0086] The suture anchor 160 can be made of a superelastic or shape memory nitinol wire. The nitinol wire has superelasticity, which enables the suture anchor to assume a compressed state, so that it can be inserted into the blood vessel wall without hooking or damaging the blood vessel wall. For example, the nitinol wire can be preformed into a certain shape, such as a hook shape, by heat treatment and used as a suture anchor. By pulling it into the delivery tube 133, the bent part of the wire can be straightened. Then, the suture is pushed out of the delivery tube, and the bent part is reformed to fix the suture. Similarly, a nitinol tube can be laser cut into a hook shape and shaped by heating the cut tube to a certain temperature. Then, the nitinol tube can be pulled back to its original tubular shape and restored to its bent hook shape when taken out of the tube after deployment. Optionally, the anchor can be arranged within a removable sheath, which can be removed to allow the anchor to return to its hook shape.

[0087] Reference Figures 6A to 6E , various types of suture anchors can be used. For example, a tube-based nitinol anchor 600, a wire-based nitinol anchor 610, and a suture knot anchor 620. The tube-based anchor 600 is located at the end of the suture 602. In the compressed or unexpanded form 604, the diameter of the anchor may be approximately the same as or slightly larger than that of the suture 602. When the anchor 600 is no longer compressed (e.g., within the delivery tube) and is allowed to reach its expanded shape 606 (e.g., when pushed out of the delivery tube), the anchor may have multiple hooks or fingers that open outward and embed into one or more layers of tissue near the opening to be closed.

[0088] Similarly, the wire-based anchor 610 can have a compressed form 612 (e.g., when it is within the delivery tube), and in the expanded form 616, it has multiple small wires that pop out and embed into the tissue. The suture-based anchor 620 (see Figure 6C ) can include a cylindrical suture knot 624 that is inserted into the tissue. When the length of the suture 622 is pulled to tension the suture 622, the knot 624 can be pulled into the expanded form 626 so that it can be attached to the tissue. Figure 6D and Figure 6E shows another exemplary embodiment of a tube-based anchor, in which a three-pronged laser-cut tube-based anchor is shown. As described above, a nitinol tube can be laser cut into a hook shape and shaped by heating the cut tube to a certain temperature. Then, the tube can be pulled back to its original tubular shape, inserted into the delivery tube of the device 100, and then restored to its bent hook shape when taken out of the delivery tube. The tube-based anchor 630 can include a tube body with a through-hole 631 provided therein. The tubular tip 632 and / or the hole 633 can be formed by laser cutting. As described above, the hole 633 can be used to connect the suture to the tube-based anchor 630. For example, a knot or a reflux suture ball can prevent the suture passing through 631 from being pulled back through the hole 633. After the tube-based anchor 630 is cut, it can be thermoformed into Figure 6EThe hook shape shown. For example, the pointed tip 630 can be formed in a hook shape that can engage and attach to one or more layers of the tissue surface. The tube base anchor can be compressed within a deployment device (e.g., the tensioning tube and / or delivery tube of the present disclosure) (e.g., as Figure 6D the shape shown). After being released from the deployment device, the tube base anchor 630 can return to Figure 6E the deployed hook shape shown. Although the anchor in FIG. 6 is described as a nitinol anchor or suture-based anchor, the anchor can also be made of other suitable materials. In addition to facilitating suture anchoring and relative strength, such anchors can also provide other advantages. Although not shown in FIG. 6, other types of anchors are also feasible, such as gauze-based anchors. In some examples, one or more anchors can have additional features to facilitate radial tightening of the opening. For example, holes (or any other openings) can be provided on one side of the anchor (e.g., Figure 6D and Figure 6E 633 on one side of the tube base anchor shown) for suture exit, where the suture coming out from one side (e.g., radially) will generate a radial or lateral force when tensioned, rather than an outward pulling force.

[0089] Although the accompanying drawings show anchor-based sutures, the present disclosure is not limited thereto, and non-anchor-based sutures can be similarly used without departing from the principles of the present disclosure. For example, the sutures can be knotted together and form knots by winding around each other within the tissue to close the opening. In other examples, low-profile suture knots can be fed into the tissue and then pulled to form larger knots to act as anchors.

[0090] Review Figures 1A to 1E , the push rod (136(a)–(d)) (or push rod) that extends distally from the push rod retainer 126 is axially disposed within the lumen of each delivery tube (i.e., each push rod extends distally from the proximal end of the corresponding delivery tube into the delivery tube). In various embodiments, when the delivery tube is properly positioned, the distal end of each push rod 136(a)–(d) is configured to push the corresponding suture anchor 160 out of the distal end of the delivery tube 133(a)–(d). In various embodiments, initially the push rod 136 and the delivery tube 133 are advanced distally synchronously. However, when the delivery tube reaches its maximum allowable advancement position, the delivery tube stops advancing forward, while the push rod continues to advance, thereby pushing the anchor 160 out of the distal end of the delivery tube. The maximum allowable advancement position of the delivery tube is determined relative to the stabilizer already deployed within the target tissue (e.g., blood vessel) to ensure that the anchor is deployed on the wall of the target tissue (e.g., blood vessel wall), rather than in the fascia outside the target tissue. As described below, the maximum allowable advancement position of the delivery tube can be controlled by using an elastic member to limit the advancement of the delivery tube retainer 124.

[0091] After the anchor is deployed, the delivery tube and the push rod automatically retract to avoid applying continuous pressure to the target tissue. Optionally, if a large advancement resistance is encountered (e.g., severe calcification), the delivery tube and the push rod can automatically retract partially to prevent an increase in deployment force when resistance is encountered during deployment (e.g., due to severe calcification).

[0092] The advancement and retraction of the delivery tube and the push rod are controlled by a suitable mechanism disposed within the housing 102. As described above, the housing 102 includes control elements and mechanisms that can be manipulated by the user to advance and trigger various functions of the delivery device, such as, (but not limited to) retracting the sheath, deploying the stabilizer, advancing the delivery tube, advancing the push rod to deploy the anchored suture, retracting the delivery tube and the push rod, retracting the stabilizer, etc. Optionally, the housing is configured to have a specific shape (e.g., handle shape) and / or the position of the control elements such that the user can easily hold the housing and manipulate the control elements with one hand and / or both hands. Examples of such mechanisms or control elements can include, but are not limited to: a slider or a plunger connected to a linear advancement type mechanism; a button connected to a spring or an elastic member type mechanism; a rotary knob based mechanism; a flip handle connected to a rack and pinion type mechanism; a squeeze handle type mechanism; or the like.

[0093] For example, Figures 8A to 8C A flip handle connected to a rack and pinion type mechanism is shown. As shown, the pinion 127(a) is connected to the flip handle 128 such that the rack and pinion mechanism is driven by the flip handle 128. The rack 127(b) is connected to the delivery tube holder 124 and the push rod holder 126. Thus, when the flip handle 128 rotates, it rotates the pinion 127(a), and this rotation is converted into a linear motion of the rack 127(b) to appropriately move and / or position the delivery tube holder 124 and the push rod holder 126. The movement of the delivery tube holder 124 and the push rod holder 126 in the distal direction causes the advancement of the delivery tube and the push rod, while the movement of the delivery tube holder 124 and the push rod holder 126 in the proximal direction causes the retraction of the delivery tube and the push rod.

[0094] As further shown in the figure, an elastic member 129 (e.g., a spring) is configured to limit the distal movement of the delivery tube holder 124. Specifically, when the delivery tube holder 124 moves distally (by the movement of the rack 127(b)), it compresses the elastic member 129. Thus, the maximum advancement position of the delivery tube is determined by the maximum compression amount of the elastic member 129. Once the elastic member 129 is in its maximum compressed state, it will prevent the delivery tube holder 124 from advancing distally (while the pusher holder can still continue to advance distally to deploy the suture anchor by pushing the suture anchor out of the delivery tube). After deploying the suture, continuously rotating the flip handle 128 in the proximal direction will retract the delivery tube holder 124 and the pusher holder 126 into the housing 102 (the elastic member 129 returns to its rest state).

[0095] Figures 8A to 8C Cross-sectional views of the housing 102 in the neutral position, the deployed position, and the retracted position are shown respectively. As Figure 8A shown, in the neutral position, the flip handle 128 is located at the distal end of the delivery device, and the delivery tube is stored within the tapered portion of the elongate member. When the flip handle is rotated towards the proximal end of the device, the delivery tube and the pusher advance distally until the suture is deployed( Figure 8B ). Continuing to rotate the flip handle, after the anchor is deployed, the delivery tube and the pusher will retract( Figure 8C ).

[0096] Figure 10 is a flowchart depicting an example method 1000 of the delivery device 100 of the present disclosure. At step 1005, the delivery device can be advanced distally over a guide wire to advance the dilator distally into a target tissue (e.g., the vessel wall). Once blood return is visually detected through the proximal port of the blood return channel (1010 = yes), the stabilizer can be deployed at 1015.

[0097] Next, at 1020, the delivery tube (including the pusher) can be advanced to the target tissue until the delivery tube reaches its maximum advancement position. Once the delivery tube reaches its maximum advancement position (1025 = yes), the pusher can push the suture anchor into the target tissue for deployment (1030). The specific location where the suture and the suture anchor are deployed around the opening may vary depending on the size, shape, and location of the opening.

[0098] Once the suture is deployed, the delivery tube including the pusher is retracted into the delivery device (1035). Finally, the stabilizer can be undeployed by contraction (1040), and the delivery device is withdrawn (1045).

[0099] When the delivery device is withdrawn, a tensioning device of, for example, a closure system can be used to manipulate the proximal end of the anchored suture to tighten the opening.

[0100] Figure 11 visually illustrates the process of deploying sutures near the entry site within the blood cavity using the delivery device 110 described above. The example in Figure 11 shows four anchor sutures deployed around the entry site 1150 in the vessel wall 1160. For example, Figure 11A shows the dilator being advanced into the blood cavity 1170 while the stabilizer is in a retracted state. The distal portion of the device is advanced within the cavity 1170 until blood reflux is observed. Figure 11B shows the stabilizer in a deployed state to properly position the delivery tube during deployment. Figure 11C shows the delivery tube deployed within the blood cavity and at its maximum advancement position. At this position, the pusher is advanced distally to deploy the suture anchor by pushing the suture anchor out of the distal end of the delivery tube ( Figure 11C where the suture anchor portion is visible). Figure 11D shows the deployed suture anchor and the retracted delivery tube while the proximal end of the suture is manipulated by a suitable closure system (900).

[0101] Each of the multiple sutures can be deployed individually. In various embodiments, the arrangement of the sutures (once deployed around the vascular opening) can be configured to effect radial tightening by pulling the sutures (e.g., via the suture anchors) towards the center of the suture arrangement where the vascular opening is located. For example, the sutures can be deployed into the tissue and / or structure around the opening such that when the sutures are tightened, the sutures effect radial inward tightening of the opening by pulling on the tissue and / or structure. Similarly, the sutures can be deployed such that they form the approximate vertices of a square, triangle, pentagon, hexagon, etc. shape, with the opening located between the arrangements (centrally or off - center). Additionally, the sutures can be deployed asymmetrically around the vascular entry site or opening depending on the size and shape of the vascular entry site or opening. Other arrangements are also within the scope of the present disclosure, for example, allowing linear tightening, etc.

[0102] A kit for closing an opening in a target tissue is also provided. Generally, the kit includes a suture delivery device that includes sutures and suture anchors, and one or more other components (detachably connected) of the delivery device. The distal end of the suture connected to the suture anchor can be disposed within the delivery tube and stored within the distal end of each delivery tube. The proximal end of the suture can be led out of the delivery tube (e.g., through the slots described above) for manipulation using any currently or future - known methods and devices. The kit can also include a suture closure system (e.g., including a tensioning device).

[0103] The kit may include an interventional device for accessing the opening. The kit may also include a guide wire.

[0104] In addition, as described above for the apparatus and method, it may be more advantageous to provide a kit that includes additional tools for practicing the method. For example, the kit may also include cutting filaments for cutting sutures, stabilizers, positioning elements, and / or suture locks.

[0105] The kit may also include instructions on how to use the contents of the kit. For example, the kit may optionally include instructions for deploying sutures using the delivery device. The instructions may include reference materials (including methods of use, etc.) and may be in any suitable format, including written, graphical, visual, electronic, etc., and may be in one or more languages.

[0106] It should be understood that terms such as "same", "equal", "flat", or "coplanar" used herein to refer to directions, layouts, positions, shapes, dimensions, quantities, or other metrics do not necessarily mean exactly the same directions, layouts, positions, shapes, dimensions, quantities, or other metrics, but rather directions, layouts, positions, shapes, dimensions, quantities, or other metrics that are nearly the same within an acceptable deviation (e.g., due to manufacturing processes). Unless the context or other statements clearly indicate otherwise, the term "substantially" may be used herein to emphasize this meaning. For example, an item described as "substantially the same", "substantially equal", or "substantially flat" may be exactly the same, equal, or flat, or may be the same, equal, or flat but within an acceptable deviation (e.g., due to manufacturing processes and / or tolerances). The term "substantially" may be used to cover this meaning, especially where such deviations do not materially alter the function.

[0107] It should be understood that the embodiments disclosed herein may be subject to various modifications. Similarly, the above methods may be performed in other orders. Accordingly, the above description should not be construed as limiting, but should only be considered as examples of various embodiments. Those skilled in the art will be able to envision other modifications within the scope and spirit of the appended claims.

[0108] Some examples of embodiments of the present disclosure may be described according to the following clauses:

[0109] Clause 1. A delivery device for suture deployment, the delivery device comprising:

[0110] A distal assembly, the distal assembly including an elongate member;

[0111] A proximal housing, the proximal housing including one or more control elements for controlling one or more components of the delivery device; and

[0112] A plurality of delivery tubes extending distally from the proximal housing into the elongate member, each of the delivery tubes comprising:

[0113] A suture anchor, which is stored within a distal portion of the delivery tube, and

[0114] A push rod, which is configured to push the suture anchor distally from the distal portion of the delivery tube for deploying the suture anchor within target tissue.

[0115] Clause 2. The delivery device according to Clause 1 further includes a guide wire lumen extending between a distal end and a proximal end of the delivery device.

[0116] Clause 3. The delivery device according to any one of the above clauses further includes a blood return channel extending between a distal port and a proximal port, the blood return channel being configured to provide an indication of correct positioning of the distal component within the target tissue based on the presence of blood in the proximal port.

[0117] Clause 4. The delivery device according to Clause 3, wherein the distal port is disposed within the distal component and the proximal port is disposed within the proximal housing.

[0118] Clause 5. The delivery device according to Clause 3, wherein the blood return channel is a passage defined by an inner guide wire lumen and an outer tube.

[0119] Clause 6. The delivery device according to any one of the above clauses, wherein the distal component further includes a dilator and a stabilizer.

[0120] Clause 7. The delivery device according to Clause 6, wherein the dilator is formed of a soft material and is configured to enlarge an initial puncture opening.

[0121] Clause 8. The delivery device according to Clause 6, wherein the dilator has a length of from about 0.5 inches to about 1 inch.

[0122] Clause 9. The delivery device according to Clause 6, wherein the stabilizer is disposed between the dilator and the elongate member.

[0123] Clause 10. The delivery device according to Clause 6, wherein in an undeployed state, the diameter of the stabilizer is substantially similar to the diameter of the dilator.

[0124] Clause 11. The delivery device according to Clause 6, wherein distal movement of the outer tube causes deployment of the stabilizer for temporarily fixing the delivery device at a location within the target tissue to correctly position the suture anchor upon deployment.

[0125] Clause 12. The delivery device according to Clause 11, wherein the proximal housing includes an actuation mechanism for controlling distal movement of the outer tube to deploy the stabilizer.

[0126] Clause 13. The delivery device according to Clause 6, wherein the stabilizer includes a cylindrical nitinol mesh configured to form a generally disc shape upon deployment of the stabilizer.

[0127] Clause 14. The delivery device according to any one of the above clauses further includes a removable sheath mounted on at least a distal portion of the elongate member.

[0128] Clause 15. The delivery device according to any one of the above clauses, wherein the elongate member includes a proximal tubular portion and a distal tapered portion.

[0129] Clause 16. The delivery device according to Clause 15, wherein the distal tapered portion includes a plurality of guiding features configured to position a plurality of delivery tubes in a desired configuration during deployment.

[0130] Clause 17. The delivery device according to any one of the above clauses, wherein each of the plurality of guiding features includes a generally semi-circular groove configured to receive and guide a delivery tube.

[0131] Clause 18. The delivery device according to any one of the above clauses further includes a passage extending from the distal end of the elongate member to the proximal housing, the passage being configured to receive a guidewire lumen, a plurality of delivery tubes, and an outer tube configured to define a blood return channel.

[0132] Clause 19. The delivery device according to Clause 18, wherein each of the plurality of delivery tubes includes an elongate tubular member extending distally from a delivery tube retainer in the proximal housing into the passage.

[0133] Clause 20. The delivery device according to Clause 19, wherein the pusher extends distally from a pusher retainer in the proximal housing into the lumen of the delivery tube.

[0134] Clause 21. The delivery device according to Clause 20, wherein the proximal housing includes a rack and pinion control mechanism configured to be actuated by a flip handle such that rotational movement of the flip handle causes the delivery tube retainer and the pusher retainer to be advanced distally.

[0135] Clause 22. The delivery device according to Clause 21 further includes an elastic member configured to stop the distal movement of the delivery tube retainer when in a fully compressed state.

[0136] Clause 23. The delivery device according to Clause 22, wherein when the distal movement of the delivery tube retainer stops, the distal movement of the pusher retainer causes the deployment of the suture anchor within the target tissue via the pusher.

[0137] Clause 24. The delivery device according to Clause 18, wherein each of the plurality of delivery tubes is disposed in the passage at a desired spacing radially around the guidewire lumen.

[0138] Clause 25. The delivery device according to Clause 18, wherein each of the plurality of delivery tubes includes a distal portion that flares outwardly relative to the passageway upon deployment.

[0139] Clause 26. The delivery device according to Clause 25, further comprising a positioning element disposed within the passageway and configured to flare the plurality of delivery tubes.

[0140] Clause 27. The delivery device according to any one of the preceding clauses, wherein each of the plurality of delivery tubes includes a slot for receiving the distal end of a suture, the distal end of the suture being coupled to a suture anchor.

[0141] Clause 28. The delivery device according to any one of the preceding clauses, wherein the delivery device includes four delivery tubes.

[0142] Clause 29. The delivery device according to any one of the preceding clauses, wherein the length of one or more of the plurality of delivery tubes is different from the length of the other delivery tubes of the plurality of delivery tubes.

[0143] Clause 30. The delivery device according to any one of the preceding clauses, wherein the suture anchor includes a nitinol anchor.

[0144] Clause 31. A method of deploying a suture using the delivery device according to any one of the preceding clauses, the method comprising:

[0145] Advancing the distal end of the delivery device into the target tissue;

[0146] Deploying a stabilizer after observing blood backflow;

[0147] Advancing the plurality of delivery tubes distally into the target tissue; and

[0148] When it is detected that the plurality of delivery tubes have reached the maximum advancement position, advancing each pusher distally into the lumen of the delivery tube to effect deployment of the suture anchor.

[0149] Clause 32. A delivery device for suture deployment, the delivery device comprising:

[0150] An outer tube concentrically disposed about a guide wire lumen to form a blood backflow channel external to the guide wire lumen;

[0151] A passageway defined by the delivery device and configured to receive the outer tube and a plurality of delivery tubes;

[0152] A plurality of delivery tubes extending distally from a delivery tube holder, each of the plurality of delivery tubes including:

[0153] A suture anchor stored within the distal portion of the delivery tube, and

[0154] A push rod that extends from a push rod retainer and is configured to push a suture anchor distally from the distal portion of the delivery tube for deploying the suture anchor within a target tissue; and

[0155] An elastic member configured to stop the distal movement of the delivery tube retainer when in a fully compressed state,

[0156] wherein when the distal movement of the delivery tube retainer stops, the distal movement of the push rod retainer causes the suture anchor to be deployed within the target tissue via the push rod.

[0157] Clause 33. The delivery device according to Clause 32, further comprising a control mechanism configured to advance the delivery tube retainer and the push rod retainer distally.

[0158] Clause 34. A method of deploying a suture using a suture delivery device, the method comprising:

[0159] Advancing the distal end of the suture delivery device into the target tissue;

[0160] After observing blood reflux, deploying a stabilizer of the suture delivery device;

[0161] Advancing a plurality of delivery tubes distally into the target tissue, each of the plurality of delivery tubes including a suture anchor and a push rod;

[0162] When it is detected that the plurality of delivery tubes have reached a maximum advancement position, advancing each push rod distally into the lumen of the delivery tube to cause deployment of the suture anchor.

Claims

1. A delivery device for suture deployment, the delivery device comprising: A distal assembly, the distal assembly including an elongate member; A proximal housing including one or more control elements for controlling one or more components of the delivery device; And A plurality of delivery tubes extending distally from the proximal housing into the elongate member, each delivery tube of the plurality of delivery tubes including: A suture anchor stored within a distal portion of the delivery tube, and A push rod configured to push the suture anchor distally from the distal portion of the delivery tube for deploying the suture anchor within a target tissue.

2. The delivery device according to claim 1, further comprising a guide wire lumen extending between a distal end and a proximal end of the delivery device.

3. The delivery device according to claim 1, further comprising a blood return channel extending between a distal port and a proximal port, the blood return channel configured to provide an indication of correct positioning of the distal component within the target tissue based on the presence of blood in the proximal port.

4. The delivery device according to claim 3, wherein, The distal port is disposed within the distal assembly and the proximal port is disposed within the proximal housing.

5. The delivery device according to claim 3, wherein, The blood return channel is a passage defined by an inner guide wire lumen and an outer tube.

6. The delivery device according to claim 1, wherein, The distal assembly further includes a dilator and a stabilizer.

7. The delivery device according to claim 6, wherein, The dilator is formed of a soft material and configured to enlarge an initial puncture opening.

8. The delivery device according to claim 6, wherein, The dilator has a length of from about 0.5 inches to about 1 inch.

9. The delivery device according to claim 6, wherein, The stabilizer is disposed between the dilator and the elongate member.

10. The delivery device according to claim 6, wherein, In an undeployed state, the diameter of the stabilizer is substantially similar to the diameter of the dilator.

11. The delivery device according to claim 6, wherein, Distal movement of the outer tube causes deployment of the stabilizer for temporarily fixing the delivery device at a location within the target tissue to properly position the suture anchor during deployment.

12. The delivery device according to claim 11, wherein, The proximal housing includes an actuation mechanism for controlling distal movement of the outer tube to deploy the stabilizer.

13. The delivery device according to claim 6, wherein, The stabilizer includes a cylindrical nitinol mesh configured to form a generally disc shape upon deployment of the stabilizer.

14. The delivery device according to claim 1, further comprising a removable sheath mounted on at least a distal portion of the elongate member.

15. The delivery device according to claim 1, wherein, The elongate member includes a proximal tubular portion and a distal tapered portion.

16. The delivery device according to claim 15, wherein, The distal tapered portion includes a plurality of guiding features configured to position the plurality of delivery tubes in a desired configuration during deployment.

17. The delivery device according to claim 1, wherein,Each guiding feature of the plurality of guiding features includes a generally semi-circular groove configured to receive and guide a delivery tube.

18. The delivery device according to claim 1, further comprising a passage extending from a distal end of the elongate member to the proximal housing, the passage configured to receive a guide wire lumen, the plurality of delivery tubes, and an outer tube configured to define a blood return channel.

19. The delivery device according to claim 18, wherein, Each delivery tube of the plurality of delivery tubes includes an elongate tubular member extending distally from a delivery tube retainer in the proximal housing into the passage.

20. The delivery device according to claim 19, wherein, The push rod extends distally from a push rod retainer in the proximal housing into the lumen of the delivery tube.

21. The delivery device according to claim 20, wherein, The proximal housing includes a rack and pinion control mechanism configured to be actuated by a flip handle such that rotational movement of the flip handle causes distal advancement of the delivery tube retainer and the push rod retainer.

22. The delivery device according to claim 21, further comprising an elastic member configured to stop distal movement of the delivery tube retainer when in a fully compressed state.

23. The delivery device according to claim 22, wherein, When distal movement of the delivery tube retainer stops, distal movement of the push rod retainer causes deployment of the suture anchor within the target tissue via the push rod.

24. The delivery device according to claim 18, wherein, Each delivery tube of the plurality of delivery tubes is disposed within the passage so as to radially surround the guide wire lumen at a desired spacing.

25. The delivery device according to claim 18, wherein, Each delivery tube of the plurality of delivery tubes includes a distal portion that flares outward relative to the passage during deployment.

26. The delivery device according to claim 25, further comprising a positioning element disposed within the passage and configured to cause the plurality of delivery tubes to open.

27. The delivery device according to claim 1, wherein, Each delivery tube of the plurality of delivery tubes includes a slot for receiving a distal end of a suture, the distal end of the suture being coupled to the suture anchor.

28. The delivery device according to claim 1, wherein, The delivery device includes four delivery tubes.

29. The delivery device according to claim 1, wherein, The length of one or more of the plurality of delivery tubes is different from the length of the other delivery tubes of the plurality of delivery tubes.

30. The delivery device according to claim 1, wherein, The suture anchor includes a nitinol anchor.

31. A method of deploying a suture using the delivery device according to claim 1, the method comprising: Advance the distal end of the delivery device into the target tissue; Deploy the stabilizer after observing blood reflux; Advance the plurality of delivery tubes distally into the target tissue; And When it is detected that the plurality of delivery tubes have reached the maximum advancement position, advance each pusher distally into the lumen of the delivery tube to cause deployment of the suture anchor.

32. A delivery device for suture deployment, the delivery device comprising: An outer tube that is concentrically disposed around the guide wire lumen to form a blood reflux channel outside the guide wire lumen; A passage defined by the delivery device, the passage configured to receive the outer tube and the plurality of delivery tubes; The plurality of delivery tubes extend distally from a delivery tube retainer, and each of the plurality of delivery tubes includes: A suture anchor stored within a distal portion of the delivery tube, and A pusher that extends from a pusher retainer and is configured to push the suture anchor distally from the distal portion of the delivery tube for deploying the suture anchor within the target tissue; and An elastic member configured to stop the distal movement of the delivery tube retainer when in a fully compressed state, wherein when the distal movement of the delivery tube retainer stops, the distal movement of the pusher retainer causes deployment of the suture anchor within the target tissue via the pusher.

33. The delivery device according to claim 32, further comprising a control mechanism configured to cause the delivery tube holder and the pusher holder to be advanced distally.

34. A method of deploying a suture using a suture delivery device, the method comprising: Advance the distal end of the suture delivery device into the target tissue; After observing blood reflux, deploy the stabilizer of the suture delivery device; Advance a plurality of delivery tubes distally into the target tissue, each of the plurality of delivery tubes including a suture anchor and a pusher; When it is detected that the plurality of delivery tubes have reached the maximum advancement position, advance each pusher distally into the lumen of the delivery tube to cause deployment of the suture anchor.

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