Percutaneous vascular access site management system

Abstract

The present disclosure provides a dynamic vascular access and closure device for radially tightening an access site. The device includes a tensioning tube, a resilient member disposed within the tensioning tube, and a plurality of sutures extending axially between a distal end of the tensioning tube and a proximal end of the tensioning tube. The proximal end of each of the plurality of sutures may be configured to attach to the resilient member such that movement of the sutures causes the resilient member to compress or stretch within the tensioning tube to tighten the sutures.

Description

[0001] Priority Claim

[0002] This application claims priority to U.S. Provisional Application No. 63 / 424,706, filed on November 11, 2022. The disclosure of the priority application is hereby incorporated by reference in its entirety. Technical Field

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

[0004] Minimally invasive catheter-based interventions have revolutionized the treatment of vascular diseases in many ways. In many interventional procedures, interventional devices are introduced into the body 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 (such as 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 passing an instrument (such as a catheter) through the sheath and to the operative location within the vascular system. While these procedures have various medical advantages, the possibility of bleeding during the procedure poses a risk to the patient. Thus, an inevitable problem in endovascular and endoluminal procedures is how to stop bleeding at the percutaneous puncture site after the procedure is completed, after removing the instrument (and any insertion sheath used therewith).

[0005] In addition, many such interventional procedures often require multiple accesses to the blood vessel, and thus the percutaneous access site must remain open for an extended period of time without causing excessive bleeding. A physician may need to manually prevent excessive bleeding when temporarily closing the blood vessel, such as when changing a catheter, dilator, or sheath. Existing devices generally do not have access site management capabilities to prevent bleeding (e.g., during placement and removal of a vascular sheath) without manual intervention and / or are not convenient for multiple accesses to the interior of the blood vessel. Such devices can close the access site at the end of the procedure, but require a new access site for subsequent re-entry.

[0006] These problems are exacerbated when large-bore access is needed (e.g., in transcatheter structural heart therapies (transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement / repair (TMVR / r), etc.), temporary mechanical circulatory support implantation (percutaneous ventricular assist device or pVAD), and percutaneous endovascular aortic abdominal aortic aneurysm repair (PEVAR), etc., where the catheter size is typically in the range of 10-24 French or larger). Existing vascular closure devices are designed for small-bore access, while many new interventional procedures require larger and more complex catheters. Therefore, some interventional procedures using larger catheters rely on surgical incisions to access veins or arteries. Using surgical incisions to access blood vessels undermines the minimally invasive nature of the interventional procedure. Additionally, the blood vessels of elderly patients are often severely calcified, which can lead to difficulties in closure and a high failure rate of traditional closure methods.

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

[0008] The disclosed solution provides a dynamic vascular access and closure device and a method of using the same.

[0009] For example, some disclosed solutions include a dynamic vascular access and closure device for radial tightening, the device including a tensioning tube that may contain an elastic member disposed within the tensioning tube; and a plurality of sutures that axially extend between the distal and proximal ends of the tensioning tube. The proximal end of each suture may be configured to be attached to the elastic member such that movement of the suture causes the elastic member to compress or extend within the tensioning tube. The elastic member may include a spring.

[0010] The distal end of each suture may be coupled to a vascular anchor. The vascular anchor may be a nitinol tube anchor (e.g., having three hooks) or a nitinol wire anchor.

[0011] The dynamic vascular access and closure device may further include a suture lock. In some embodiments, the suture, the vascular anchor, and the suture lock may be made of a bioabsorbable material. The vascular anchor may be a nitinol anchor. In some embodiments, the proximal end of each of the plurality of sutures may include a suture stopper.

[0012] The dynamic vascular access and closure device may further include an elastic member stopper located within the tensioning tube (e.g., a step defined by a change in the inner diameter of the tensioning tube). Optionally, an applicator may be provided at the proximal end of the elastic member. Compression or extension of the elastic member against the elastic member stopper may be the applicator compressing the spring against the elastic member stopper.

[0013] In some embodiments, at least one suture may be configured to attach to a blood vessel, and a distal end of the at least one suture may be configured to attach to a tensioning tube. In a further embodiment, an elastic member may be configured to be in a first position to tighten a blood vessel entry site located between sutures when the sutures are attached to the blood vessel; or, when the sutures are pulled to open the blood vessel entry site, the elastic member is in a second position, wherein a first length of the elastic member in the first position is greater than a second length of the elastic member in the second position.

[0014] Another alternative may include a dynamic blood vessel entry and closure device, the device comprising: a plurality of sutures having proximal and distal ends, each of the plurality of sutures being provided with a suture stopper at a respective proximal end; and a tensioning tube assembly, the tensioning tube assembly comprising: a body having a distal end and a proximal end, and a spring. The sutures may extend axially through the tensioning tube body, and pulling the sutures may apply pressure to the spring through the suture stoppers. When the plurality of sutures are deployed into the blood vessel, the opening of the blood vessel entry site located between the plurality of sutures may cause the plurality of sutures to be tensioned.

[0015] The distal end of each suture may include a blood vessel anchor. The blood vessel anchor may be a nitinol tube anchor (e.g., having three hooks) or a nitinol wire anchor.

[0016] The suture stopper may be a knot located at the proximal end of the suture. The dynamic blood vessel entry and closure device may further include an applicator, which may be a hollow tube coaxial with the tensioning tube body and at least partially disposed inside the tensioning tube body such that the distal end of the applicator contacts the proximal end of the spring. In some embodiments, the suture stopper is disposed outside the proximal end of the applicator. Optionally, the position of the applicator relative to the tensioning tube may be adjusted to increase or decrease the pressure applied to the spring.

[0017] The dynamic blood vessel entry and closure device may further include a suture lock. The suture lock may be disposed at the distal end of the tensioning tube and may be locked onto the sutures when the sutures are tensioned. The suture lock may be a ferrule configured to crimp onto the plurality of sutures. In other embodiments, the suture lock may be a semi-permanent suture lock.

[0018] Another scenario may include a dynamic vascular access and closure device for radial suture tightening, comprising: a plurality of vascular anchors configured to attach to a blood vessel; a plurality of sutures having proximal and distal ends, the proximal end provided with a suture stopper and the distal end connected to the vascular anchor; a tensioning tube having a distal end and a proximal end, the distal diameter of the tensioning tube being smaller than the proximal diameter of the tensioning tube; and an inner biasing tube at least partially disposed within the proximal end of the tensioning tube. The dynamic vascular access and closure device may further include a compression spring having a distal end and a proximal end, the spring being disposed inside the tensioning tube, between the distal end of the tensioning tube and the inner biasing tube, wherein the distal end of the spring contacts a shoulder of the tensioning tube, and the proximal end of the spring contacts the distal end of the biasing tube and a suture lock disposed between the distal end of the tensioning tube and the anchor. The sutures may extend axially through the tensioning tube, the inner biasing tube, the spring, and the suture lock. The proximal end of the inner biasing tube may contact the suture stopper. The inner biasing tube may be configured to transmit spring force from the compression spring to the plurality of sutures to cause opening or closing of the vascular access site located between the plurality of anchors when deployed on the blood vessel.

[0019] In various scenarios, a method of using any dynamic vascular access and closure device may include: deploying a plurality of sutures around a vascular access site (e.g., via vascular anchors), inserting an intervention device into the vascular access site, and removing the intervention device from the vascular access site. Inserting the intervention device into the vascular access site may cause the plurality of sutures to be tensioned due to an increase in the diameter of the vascular access site and compression of the compression spring. Removing the intervention device may cause the compression spring to expand and effect dynamic closure of the vascular access site by tightening the plurality of sutures.

[0020] Other embodiments include a dynamic vascular access and closure device for radial tightening, the device including a tensioning tube within which an elastic member is disposed; a plurality of sutures that axially extend between the distal and proximal ends of the tensioning tube; and a tension lock having a first position and a second position. The proximal end of each of the plurality of sutures may be configured to attach to the elastic member such that movement of the plurality of sutures causes the elastic member to be compressed or extended within the tensioning tube. In the first position, the tension lock may be configured to hold the elastic member in a compressed state, thereby slackening the sutures; in the second position, the tension lock may be configured to allow the elastic member to extend, thereby tensioning the sutures. The tension lock may be a frangible bridge or a trigger suture.

[0021] The tensioning tube may further include slots, and the applicator may further include pins. In the first position, the pins may engage a stop on the tensioning tube. In the second position, the applicator may be rotated to cause the pins to engage the slots.

[0022] Other embodiments include a dynamic vessel access and closure device that includes a plurality of sutures, each suture having a proximal end and a distal end, with each suture of the plurality of sutures having a suture stop at its respective proximal end; a tensioning tube that includes a body having a distal end and a proximal end, and a protrusion; and a spring assembly that includes: a body having a distal channel and a longitudinal slot, the channel being configured to receive the protrusion of the tensioning tube; a spring disposed within the body; and a rod at least partially disposed within the body and connected to the spring. Each suture of the plurality of sutures can axially extend through the body of the tensioning tube; and the proximal end of each suture of the plurality of sutures can extend through the longitudinal slot of the body and be connected to the rod.

[0023] The spring can be a constant force spring. The rod can also include a pin that can be connected to the spring. The longitudinal slot can open onto the body surface such that the proximal portion of the tensioning tube and the proximal portion of each suture can be placed within the body through the slot. The spring assembly can also include a lock release device. The tension lock can include at least one of a button, a slide switch, or a pin.

[0024] The proximal portion of the rod can extend outside the body. The dynamic vessel access and closure device can also include suture anchors, where the suture anchors are configured to attach each of the plurality of sutures to the rod of the spring assembly. The rod can have a recess; and the suture anchor can have a protrusion configured to be received within the recess.

[0025] In various cases, other methods of using a vessel access and closure device can include deploying a plurality of sutures around a vessel access site, inserting an intervention device into the vessel access site, attaching a spring assembly to the sutures, using the spring assembly to tension the sutures, removing the intervention device from the vessel access site, using the tensioned sutures to automatically close the vessel access site and lock the sutures. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a perspective view of an exemplary dynamic vessel access and closure device.

[0027] Figure 2 is Figure 1 an enlarged view of the distal end of the dynamic vessel access and closure device of

[0028] Figure 3 is Figure 1 an enlarged view of the proximal end of the dynamic vessel access and closure device of

[0029] Figure 4A is Figure 1 a cross-sectional view of the dynamic vessel access and closure device of

[0030] Figure 4BA cross-sectional view showing an alternative arrangement of the dynamic vessel access and closure device.

[0031] Figure 5A Various examples of vessel anchors are shown.

[0032] Figure 5B An exemplary tube-based vessel anchor is shown.

[0033] Figure 5C An exemplary tube-based vessel anchor in a deployed state is shown.

[0034] Figure 6A An example of a semi-permanent suture lock is shown.

[0035] Figure 6B Additional exemplary semi-permanent suture locks are shown.

[0036] Figure 7 Various examples of suture placement configurations on the vessel wall are shown.

[0037] Figure 8 A schematic diagram showing an example method of using a dynamic vessel access and closure device.

[0038] Figure 9 A flowchart showing an exemplary method of using a dynamic vessel access and closure device.

[0039] Figure 10A A perspective view of an alternative arrangement of an exemplary dynamic vessel access and closure device.

[0040] Figure 10B Is Figure 10A A cross-sectional view of the exemplary dynamic vessel access and closure device in the first position in

[0041] Figure 10C Is Figure 10A A cross-sectional view of the exemplary dynamic vessel access and closure device in the second position in

[0042] Figure 11A An enlarged view of the proximal end of the exemplary dynamic vessel access and closure device in the first position in Figure 10.

[0043] Figure 11B An enlarged view of the proximal end of the exemplary dynamic vessel access and closure device in the second position in Figure 10.

[0044] Figure 12A A side view of an alternative arrangement of the exemplary dynamic vessel access and closure device in the first position.

[0045] Figure 12B Is Figure 12ASide view of an alternative arrangement of the exemplary dynamic vessel access and closure device in the second position.

[0046] Figure 12C Is Figure 12A Cross-sectional view of a part of the exemplary dynamic vessel access and closure device.

[0047] Figure 13A Perspective view of an alternative arrangement of the exemplary dynamic vessel access and closure device in the first position.

[0048] Figure 13B Is Figure 13A Perspective view of the exemplary dynamic vessel access and closure device in the second position in

[0049] Figure 14A Perspective view of an alternative arrangement of the exemplary dynamic vessel access and closure device in the first position.

[0050] Figure 14B Is Figure 14A Perspective view of the exemplary dynamic vessel access and closure device in the second position in

[0051] Figure 14C Is Figure 14A Perspective view of the exemplary dynamic vessel access and closure device in the third position in

[0052] Figure 15A Flowchart showing another exemplary method of using the dynamic vessel access and closure device.

[0053] Figure 15B Is Figure 15A Schematic diagram of a part of the exemplary method.

[0054] Figure 15C Is Figure 15A Schematic diagram of a part of the exemplary method.

[0055] Figure 15D Is Figure 15A Schematic diagram of a part of the exemplary method.

[0056] Figure 15E Is Figure 15A Schematic diagram of a part of the exemplary method.

[0057] Figure 15F Is Figure 15A Schematic diagram of a part of the exemplary method.

[0058] Figure 15G Is Figure 15A Schematic diagram of a part of the exemplary method.

[0059] Figure 15H IsFigure 15A Schematic diagram of a part of an exemplary method.

[0060] Figure 16 Is a perspective partial exploded view of an alternative arrangement of an exemplary dynamic vascular access and closure device in a first position.

[0061] Figure 17 Is Figure 16 Perspective view of an alternative arrangement of the exemplary dynamic vascular access and closure device in a second position in

[0062] Figure 18 Is a flowchart showing another exemplary method of using a dynamic vascular access and closure device.

[0063] Figure 19A Is a perspective view of the distal end of an exemplary dynamic vascular access and closure device with a tensioned suture.

[0064] Figure 19B Shows a side view of an exemplary dynamic vascular access and closure device, where the tensioned suture shows the direction of the force. Detailed Description

[0065] The devices and methods of the present disclosure can be more easily understood by reference 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 devices, methods, 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 references to a specific numerical value include at least that specific value, unless the context clearly dictates otherwise. Ranges can be expressed herein as from "about" or "approximately" one specific value and / or to "about" or "approximately" another specific value. When expressing such a range, another embodiment includes from one specific value and / or to another specific value. Similarly, when a numerical value is expressed as an approximation using the antecedent "about", it should be understood that the specific value constitutes another embodiment. It should also be understood that all spatial references, such as proximal, distal, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can vary within the scope of the present disclosure. For example, the references "upper" and "lower" are relative and are used only in context and are not necessarily "above" and "below". Although the examples provided in the present disclosure generally relate to percutaneous management of vascular access sites (i.e., within blood vessels), the disclosed systems and methods can be used for the management of other access sites, such as but not limited to access sites in various visceral organs. For example, the disclosed embodiments can be used to manage access sites in the heart (e.g., inside or outside the heart) or the gastrointestinal tract.

[0066] As used herein, the term "proximal" refers to the closest to the operator (less into the body), and "distal" refers to the farthest from the operator (more into the body). When positioning a medical device from a downstream access site, "distal" refers to more upstream, and "proximal" refers to more downstream.

[0067] As used herein, the term "suture" can be a single - filament or multi - filament elongated flexible tensioning device made of flexible or non - flexible materials, having sufficient tensile strength to provide the required force. Sutures can be strands, wires, cords, fibers, yarns, filaments, cables, threads, etc., and these terms can be used interchangeably. Suture materials are generally divided 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, etc.

[0068] As used herein, the terms "close", "closed", "closing" 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.

[0069] Medical procedures may require access to the internal space of a blood vessel. This can be achieved by inserting an interventional device (e.g., a dilator or catheter) through the vessel wall. In some procedures, it may be necessary to temporarily remove the interventional device and / or insert another interventional device. Since the interventional device creates an opening in the vessel wall, there is a risk of bleeding when it is removed. Manually clamping the blood vessel is feasible, but this requires the doctor (and / or assistant) to continuously clamp the blood vessel before closing the vessel and / or inserting another interventional device, which can be difficult and still result in some blood loss. Then, the doctor still has to close the opening after the procedure is completed. Additional blood loss may occur during the closing process. In addition, the interventional device may cut the suture used to close the vessel access site. The devices and methods disclosed herein are intended to improve at least one of the above problems. However, it should be understood that the disclosure herein is not limited to solving these specific problems. Moreover, although the devices and techniques disclosed herein are described with respect to humans or patients, it should be understood that these devices and techniques can be applied to non - human patients (i.e., in veterinary medicine) where appropriate.

[0070] In various embodiments, the present disclosure describes a vascular access and closure device that places a tightening suture in the vessel wall and creates an access site through the vessel wall within the region defined by the tightening suture. One or more intervention devices can be inserted directly through the access site or through a catheter sheath to perform an intervention procedure within the patient's vascular system. Once the intervention device is withdrawn temporarily and / or permanently, the tightening suture automatically tightens, closing the access site into the vessel. Optionally, during suture deployment, the suture is in a relaxed state (i.e., without tension) to avoid the intervention device cutting the suture during insertion. After the intervention device is inserted, the suture is tightened. Once the intervention procedure is complete and access to the vessel is no longer needed, optionally, a suture lock or knot can be used to lock the tightened suture. The tightening suture also allows repeated access to the vessel while minimizing, inhibiting, and / or preventing substances from flowing through the vessel opening during and / or after the procedure. Thus, the device of the present disclosure can reduce the resources (e.g., personnel time, materials, etc.) used to control or substantially eliminate bleeding / effusion / exudate. The device can be used by various populations to quickly stop leakage and / or promote wound healing. The disclosed aspects 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 using, for example, a surgical endoscope.

[0071] Furthermore, the vascular access and closure device of the present disclosure allows the use of a single device to provide access to the vascular lumen, regardless of the diameter of the intervention device. Specifically, embodiments of the present disclosure can be used with intervention devices having a diameter of approximately 8 French to approximately 30 French. However, the present disclosure is not limited to such a size range of intervention devices. In some embodiments, intervention devices of other sizes can be used. For example, the devices of certain embodiments can be used in conjunction with devices having sizes of 12 - 24 French, 6 - 12 French, 9 - 24 French, 10 - 30 French, and larger or smaller sizes. Although the devices discussed herein are related to promoting hemostasis, the devices and methods disclosed herein can also be used for other applications to achieve different results, such as for managing access sites to the heart or gastrointestinal tract. For example, the anchors and sutures of the current access and closure device can be deployed near and / or around an opening in the heart and can be controlled as disclosed herein to provide access and hemostasis for such an opening.

[0072] Now referring to the drawings, and in particular Figure 1-5, which shows and describes an exemplary dynamic vascular access and closure device 10. The dynamic vascular access and closure device 10 can be used to facilitate selective access to the interior of a blood vessel in the body by dynamically opening, closing, and reopening an access site (e.g., a hole or opening) in the blood vessel. For example, suture anchors can be deployed around the access site in the vessel wall. Sutures attached to the suture anchors can be selectively tightened and relaxed by an elastic member disposed within a tensioning tube, as described below, to dynamically open and close the hole. In various embodiments, the arrangement of the suture anchors (once deployed around the blood vessel opening) can be configured to radially tighten the blood vessel opening dynamically and automatically by pulling the suture anchors towards the center of the suture arrangement (where the blood vessel opening is located) (discussed below in connection with Figure 19A and 19B . For example, the suture anchors can be deployed in a ring around the blood vessel opening such that when the suture is tensioned, the suture anchors tighten around the opening like a drawstring. Similarly, the suture anchors can be deployed at the vertices of a shape approximating a square, triangle, pentagon, hexagon, etc., with the blood vessel opening located approximately at the center of the structure. However, other arrangements are also within the scope of the present disclosure, such as allowing linear tightening, etc.

[0073] As Figure 1 shown in - FIG. 5, the dynamic vascular access and closure device 10 includes a tensioning tube 20 having a distal end 22 and a proximal end 24. The distal end 22 is the working end placed near the blood vessel. One or more suture filaments 40A-D (also interchangeably referred to as sutures or threads) extend axially between the distal end 22 and the proximal end 24 through the tensioning tube 20, with the distal end of each suture coupled to a suture anchor (suture anchors 50A-D). An elastic member 90 and an applicator 30 are at least partially disposed within the tensioning tube 20.

[0074] As shown, the tensioning tube 20 includes an elongated hollow tubular outer shaft 201 that defines a lumen 202 through which other components can pass or be placed. Although the tensioning tube 20 shown in the figures has a circular cross-section, other cross-sections, such as square, rectangular, oval, etc., are also within the scope of the present disclosure. The lumen 202 can include a first portion 202(a) having a diameter smaller than a second portion 202(b). The smaller diameter of the first portion 202(a) is large enough to allow the suture filaments 40A-D to pass freely. The larger diameter of the second portion 202(b) is large enough to accommodate the elastic member 90 and the applicator 30 (as Figure 4Aas shown). For example, the smaller inner diameter of the first portion 202(a) can be from about 0.020 inches to about 0.030 inches, while the larger inner diameter of the second portion 202(b) can be from about 0.035 inches to about 0.050 inches. However, other larger and / or smaller sizes are also possible. For example, the inner diameter of the first portion can vary according to the number and / or diameter of the sutures, while the inner diameter of the second portion can vary according to the size of the elastic member.

[0075] In various embodiments, the tensioning tube 20 can include an elastic member stopper 70. The elastic member stopper 70 can take various forms. For example, a step defined by the tensioning tube diameter changing from a larger cavity diameter to a smaller cavity diameter (as Figure 1 shown), the tensioning tube 20 tapering from a larger cavity diameter to a smaller cavity diameter, a pin or other structure extending perpendicular to the main axis of the tensioning tube 20 through the cavity 202, or other suitable forms.

[0076] The tensioning tube 20 can be made of various materials, such as polymers (e.g., plastics, rubbers, etc.), metals or alloys (e.g., titanium, stainless steel), or any other suitable material or combination of materials that have sufficient stiffness to prevent deformation under the compressive loads applied by the tensioned sutures 40A-D.

[0077] The applicator 30 can be an inwardly biased tube that is at least partially disposed within the inner cavity 202 of the proximal end 24 of the tensioning tube 20 such that the distal end of the applicator can be located within the inner cavity 202 while the proximal end is outside the inner cavity 202. In various embodiments, the applicator 30 can be an empty tube. In various embodiments, the applicator 30 can move freely relative to the tensioning tube 20. Although the applicator 30 shown in the figures has a circular cross-section, other cross-sectional shapes can also be used, such as square, rectangular, oval, or other shapes. The applicator 30 and the tensioning tube 20 can have similar or different cross-sectional shapes. The applicator 30 can also be made of various materials, such as plastics or metals, having sufficient stiffness to prevent deformation under the compressive loads applied by the tensioned sutures 40A-D.

[0078] The tubular elastic member 90 can be disposed within the tensioning tube 20, between the elastic member stop 70 and the distal end of the applicator. In various embodiments, the elastic member can be a helix, such as a spring and / or other types of elastic members that can be compressed against the elastic member stop 70, as discussed in more detail below. For example, the elastic member 90 can be an elastic tube or other structure that can be repeatedly compressed and decompressed when an axial force is applied at one or both of its ends, such as but not limited to an air spring, a hydraulic / gas spring, a motor, or any elastic member known now or hereafter. For example, the elastic member 90 can be a linear actuator configured to tension the sutures 40A-D. In such examples, the sutures 40A-D can be disposed around the perimeter of the actuator and pass through the applicator member 30.

[0079] Optionally, the elastic member 90 can be replaced with a suture tensioning motor. In some such embodiments, the applicator member 30 may not be required. For example, the interior of the tensioning tube 20 can contain a motor with a shaft to which the sutures 40A-D can be attached. The shaft can be rotated to tension the sutures. The motor can be configured to apply a specific amount of torque, which can effectively close the vascular opening, but can also be overcome by an instrument (such as a dilator) that separates the suture anchors and dilates the opening.

[0080] Figure 4A is a cross-sectional profile view of the center of the dynamic vascular access and closure device 10. This view shows the sutures 40A-D extending axially through the length of the tensioning tube 20 and the applicator 30. The elastic member 90 is disposed between the applicator 30 and the elastic member stop 70. As Figure 4A shown, the elastic member 90 can be a helical spring or a compression spring, and the sutures 40A-D are configured to pass through the helical spring.

[0081] In some embodiments, the applicator member 30 can be a tube that also contains internal steps or tapers for defining a change in the inner diameter of the tube (not shown here). The larger inner diameter can be provided at the distal end of the applicator member 30 and can be configured to fit around the elastic component 90. For example, if the elastic component 90 is a spring, the proximal end of the spring can be mounted within a recess of the applicator member 30. This configuration helps to reduce or eliminate any jamming that may occur between the tensioning tube 20 and the elastic component 90.

[0082] As shown, suture(s) 40A-D can extend axially through tension tube 20, applicator 30, and elastic member 90. Suture 40A-D can be a monofilament or multifilament thread. The suture can use a variety of materials. Suture materials can generally be divided into two categories: absorbable materials (which can decompose and be absorbed by the body) and non-absorbable materials (which should be manually removed from the body). Suture materials include, but are not limited to, polyglycolic acid, polylactic acid (PLA), polypropylene, stainless steel, nylon, or other materials. Although the drawings of the present disclosure show four sutures, in various embodiments, more or fewer sutures can be used, depending, for example, on the access site and / or the diameter of the intervention device. For example, Figure 7 Exemplary embodiments with two, four, and six sutures are shown. The number of sutures and suture anchors may depend, for example, on the size of the vascular access site (which in turn may depend on the size of the intervention device to be used). For example, when the diameter of the intervention device is 6-12 French, 2 sutures can be used; when the diameter of the intervention device is 12-24 French, 4 sutures can be used; when the diameter of the intervention device is greater than 24 French, 6 sutures can be used.

[0083] As Figure 1 and Figure 2 shown, the distal end of each suture is coupled to a corresponding suture anchor 50A-D. Suture anchors 50A-D can be deployed on the vascular surface to attach suture 40A-D to the vascular surface. Various forms of suture anchors 50A-D will be described in more detail below. First, suture anchors 50A-D are configured to be located within a deployment device so that, as an insertion mechanism (such as a needle tip) of the deployment device, when suture anchors 50A-D pass through the vascular wall in the distal direction (to create an access site or hole), suture anchors 50A-D will smoothly move forward to the outside of the deployment device (without hooking tissue). After the deployment device is deployed, suture anchors 50A-D will open or expand and anchor the distal end of suture 40A-D to the vascular wall. When the deployment device is withdrawn, suture 40A-D will remain in the vascular wall and be anchored by suture anchors 50A-D. Those skilled in the art should understand that any currently or hereafter known deployment device can be used to deploy suture anchors around the access site of the vascular wall. In addition, before and / or after deploying the suture anchors, the suture(s) coupled to the suture anchors can be passed through the tension tube of the present disclosure device.

[0084] In various embodiments, a suture lock 60 can be provided for locking suture 40A-D after the vascular access site is permanently closed (described in more detail below). Figure 2 The distal end 22 of the dynamic vascular access and closure device 10 is shown, where a close-up view of suture anchors 50A-D and suture lock 60 is shown. As Figure 2As shown, the distal ends of suture lines 40A - D can be fixed to one of the suture anchors 50A - D. The suture anchors 50A - D can be deployed after being inserted into the blood vessel wall, thereby providing support for the fixation of the suture line in the blood vessel wall.

[0085] The suture anchors 50A - D can be made of superelastic or shape - memory nitinol wire and / or tube. The nitinol tube / wire can have superelasticity, making the anchor in a compressed state for insertion into the blood vessel wall without hooking or damaging the blood vessel wall. For example, the nitinol wire can be pre - formed into a certain shape, such as a hook shape, through heat treatment, as Figure 1 and Figure 2 shown, and used as a suture anchor. The bent part of the wire can be straightened by pulling it into a deployment device. After the deployment device is advanced to the blood vessel wall, the wire is pushed out and the bent part reforms, thus anchoring the suture line. Similarly, the 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, placed in the deployment device, and restored to its bent hook shape after being taken out of the deployment device. For example, Figure 2 the hook - shaped suture anchors 50A - D in

[0086] Although Figure 1-2 the forks or filaments of the anchors 50A - D in Figure 5A are shown as three forks, the number of forks of the anchor can be more or fewer. Referring to Figure 5B and 5CAnother exemplary embodiment of an exemplary tube-based anchor, where an exemplary trifurcated laser-cut tube-based anchor is illustrated. 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 tube shape, placed in a deployment device, and upon removal from the deployment device, it resumes its curved hook shape. The tube-based anchor 500 can include a tube body with a through-hole 510 provided thereon. Forks 530 and / or holes 520 can be laser-cut on the tube. The hole 520 can be used to connect a suture to the tube-based anchor 500, as described above. For example, a knotted or refluxed suture ball can prevent the suture passing through 510 from being pulled back through the hole 520. After the tube-based anchor 500 is cut, it can be heated and formed into Figure 5C the hook shape shown. For example, the forks 530 can be formed into hooks that can engage the blood vessel wall. Then, the tubular anchor can be compressed within the deployment device (e.g., in the shape as Figure 5B shown). When released from the deployment device, the tubular anchor 500 can resume to Figure 5C the deployed hook shape shown.

[0087] Review Figure 5A , similarly, the wire-based anchor 110 can have a compressed form 114 (e.g., when it is located within the tube for deployment), and in the expanded form 116, it has various fine wires that pop out and contact the blood vessel wall. Without departing from the principles of the present disclosure, non-anchor-based sutures can be used similarly. For example, the sutures can be tied to each other and form knots by winding around themselves within the tissue to close the opening. In other examples, a low-profile suture knot can be delivered into the tissue and then pulled to form a larger knot that can act as an anchor. For example, the suture-based anchor 120 can include a cylindrical suture knot 124 inserted into the interior of the blood vessel. When the length of the suture 122 is pulled to tighten the suture 122, the knot 124 can be pulled into the expanded form 126 so that it can contact the interior of the blood vessel wall. Although the anchors in FIG. 5 are described as nitinol anchors or suture-based anchors, the anchors can also be made of other suitable materials. In addition to being easy to deploy and having relative strength, such vascular anchors can also offer other advantages. For example, in elderly patients, the blood vessels of the patient are often calcified, which makes it more difficult for traditional sutures to penetrate the blood vessels percutaneously. The disclosed vascular anchors can still penetrate the calcified blood vessel wall, thus closing the blood vessel more easily than without an anchor.

[0088] In some examples, one or more anchors can have additional structures to facilitate radially tightening the opening. For example, holes (or any other openings) can be provided on one side of the anchor for suture exit, so that the suture pulled from one side (e.g., radially) will generate a radial or lateral force when tensioned, rather than an outward pulling force.

[0089] Although not shown in FIG. 5, other types of anchors are also feasible, such as pledget-based anchors. A pledget-based anchor may include a suture that forms a loop through the vessel wall and is tied or otherwise secured to a pledget outside the vessel wall. In this example, the pledget can serve both as a fixation point for the suture and as a reinforcement point for the vessel wall. In some embodiments, sutures 40A-D, anchors 50A-D, and suture locks 60 can dissolve in the patient's body. One or more of sutures 40A-D, anchors 50A-D, and suture locks 60 can be made of a bioabsorbable material that can decompose in the human body (such as, but not limited to, PLA).

[0090] Although the accompanying drawings illustrate anchor-based sutures, the present disclosure is not so limited, and non-anchor-based sutures can equally be used without departing from the principles of the present disclosure. Optionally, sutures 40A-D may not include an attachment device or anchor attached to the vessel wall (e.g., for elderly patients with vessel wall calcification / thickening, which makes it difficult to use anchor-based sutures). Instead, the suture can be inserted into the vessel, extend through a portion of the internal space of the vessel, and exit at a different location on the vessel. Figure 7 This non-anchor-based suture connection is also illustrated (e.g., as shown by suture attachment devices 170-190 in Figure 7 . In some embodiments where no anchor is used, the suture can pass through the vessel and reconnect to the tensioning tube.

[0091] Sutures 40A-D may also include suture stops at the corresponding proximal ends or nearby. Figure 3 The proximal end 24 of the tensioning tube 20 is shown, where the proximal ends of sutures 40A-D are exposed at the proximal end of the force application member 30. The suture stop can take various forms, including but not limited to knots on the suture, ferrules crimped onto the suture, reusable suture locks (such as Figure 9 shown) or other suitable alternatives. Consistent with the disclosed embodiments, the suture stop can be made of a variety of materials, including suture material, plastic (such as PLA), titanium, etc. Optionally, the suture stop can also be an attachment and / or connector of the tensioning tube body.

[0092] The suture stopper is arranged such that the lengths of the sutures 40A-D between the suture anchors 50A-D and the suture stopper always remain unchanged. Additionally, the suture stopper is locked in a fixed position relative to the elastic member 90 and / or the applicator 30 such that the suture stopper can compress or release the elastic member 90 between the applicator 30 and the elastic member stopper 70. When the suture and the suture anchor are initially inserted into the vascular access site, the elastic member 90 is in a semi-compressed state (and / or a stationary state), and the access site is tightened by the sutures 40A-D (the length of the sutures 40A-D between the suture anchors 50A-D and the suture stopper and / or the semi-compressed state of the elastic member is configured to cause the tightening). However, when an interventional device (e.g., a catheter, a dilator, a sheath, etc.) is inserted through the access site, as the diameter of the access site increases, the sutures 40A-D are pulled apart and tensioned, such that the suture stopper causes further compression of the elastic member 90. In the tensioned state, the sutures can close the vascular membrane at the access site, wrapping the interventional device, thereby minimizing leakage when entering the vascular lumen, while expanding the access site opening as needed to allow the interventional device to enter the vascular lumen. Once the interventional device is removed from the access site, the diameter of the access site decreases, and the kinetic energy stored in the compressed elastic member 90 is released, causing the sutures 40A-D to tighten the access site and the elastic member 90 to move back to its semi-compressed state (and / or stationary state). Thus, the vascular access and closure device 10 can provide dynamic vascular access through the access site, allowing the interventional device to be repeatedly inserted into the access site, while automatically (temporarily and / or permanently) closing the access site in the absence of the interventional device.

[0093] See Figure 4B , alternative configurations of the tensioning tube, the elastic member, the elastic member stopper, and / or the applicator can be used. In some embodiments, the tension of the suture may not be adjustable based on factors other than the spring force of the elastic member (e.g., as described below with respect to configurations 410, 412, and 414). In some other embodiments, the tension of the suture can be adjusted based on factors other than the spring force of the elastic member (e.g., as described below with respect to configurations 420 and 422).

[0094] For example, configuration 410 may include the proximal ends of sutures 40A-D being directly coupled or attached to a portion of the elastic member 90 (e.g., near or at the distal end), while the proximal end of the elastic member 90 is connected to the closed proximal end of the tensioning tube 20. In such an embodiment, a force applicator or an elastic member stopper may not be provided. Instead, in such a configuration 410, the elastic member 90 is configured to withstand an elastic force (e.g., tension) by stretching against the closed proximal end of the tensioning tube 20 (compared to the rest state of the elastic member). For example, the suture length may be configured such that when the access site opening expands to insert the intervention device, the elastic member will stretch. When the intervention device is removed, the elastic member will automatically return to its rest state, thereby tightening and closing the access site. Other non-adjustable configurations, such as configuration 412 and 414, may cause the elastic member 90 to withstand a compressive force when the access site opening expands to insert the intervention device. For example, in configuration 412, sutures 40A-D may axially extend through the center of the elastic member 90, bypass the proximal end of the elastic member 90, and then fold back and connect to the inner surface of the tensioning tube 20, such as at the elastic member stopper 70. Thus, in configuration 412, when the sutures 40A-D are pulled distally due to the expansion of the access opening, the sutures 40A-D will cause the elastic member 90 to compress against the elastic member stopper 70. When the intervention device is removed, the elastic member will automatically return to its rest state, thereby tightening and closing the access opening. It should be noted that in configuration 416, a compression distance "x" of the elastic member 90 will cause the connected suture to elongate "2x". As another exemplary configuration, configuration 414 may include a suture stopper 416 located at the proximal end of the elastic member 90, such as a knot, a ball, a crimped stopper, or other suitable member. In this configuration, sutures 40A-D may axially extend through the elastic member 90, and the stopper 416 contacts the elastic member 90 and transfers the tension in the sutures 40A-D to the elastic member 90, thereby causing the elastic member to compress when the access site opening expands.

[0095] As described above, configurations 420 and 422 illustrate embodiments where the suture tension also depends on other factors than the spring force of the elastic member. For example, the suture tension may be adjusted by moving the force applicator 30 relative to the position of the sutures 40A-D within the tensioning tube 20, thereby allowing the elastic member 90 to apply a greater or lesser tension to the sutures 40A-D. In configurations 420 and 422, the sutures 40A-D may both axially pass through the elastic member 90 and be coupled to the force applicator 30, which is movable relative to the sutures within the tensioning tube. For example, the force applicator 30 may be a tube or a ferrule that is crimped onto the sutures 40A-D in a manner that allows the force applicator 30 to slide on the sutures 40A-D. In Figure 4BIn the example, by sliding the force applicator 30 to the left, the user can compress the elastic member 90, thereby increasing the tension applied to the sutures 40A-D during use. For example, in some cases, additional tightening force may be required to fully stop bleeding (i.e., the force is greater than that allowed by the elastic member itself), and the user can increase the suture tension by adjusting the position of the force applicator relative to the elastic member. Conversely, if the force applicator 30 is slid to the right in Figure 4B Figure 4B , the force applicator 30 can expand, thereby reducing the tension placed on the sutures 40A-D. In some embodiments, as shown in configuration 420, the elastic member 90 can also be attached to the force applicator 30. In other embodiments, as shown in configuration 422, the force applicator 30 may not be attached to the elastic member 90. Thus, the user can utilize the adjustability of the position of the force applicator relative to the elastic member to further dynamically adjust the tightening force according to the specific application (i.e., in addition to the force provided by the elastic member). For example, a larger entry site or larger blood vessel may require a greater tightening force (i.e., higher suture tension) to stop bleeding compared to a relatively smaller entry site or blood vessel.

[0096] In some embodiments, the elastic member 90 can be modular. For example, the elastic member 90 can be detached from the tensioning tube 20. Elastic members 90 of different strengths or sizes can be interchanged within the system to provide tension for different applications. The elastic member 90 can also be modularly connected to the tensioning tube 20 on which the sutures 40A-D are pre-installed. In another embodiment, the sutures can be fed into the tensioning system after placement of the sutures.

[0097] Optionally, when the sutures 40A-D are tightened to close the entry site, the guide wire can continue to extend from the entry site. When access to the blood vessel is required, a new interventional device can be placed on the guide wire and pushed into the opening. Optionally, instead of using a guide wire, the tensioning tube 20 can be used as a positioning tool to guide the interventional device towards the entry site.

[0098] In some example embodiments, a suture stopper may be coupled to the proximal end of the force application member 30 and prevent the proximal ends of the sutures 40A-D from slipping past the force application member 30 and beyond the stopper. Thus, when the sutures around the access site are pulled apart, the suture stopper will tension the sutures 40A-D and cause the elastic member 90 to compress (or stretch) via the force application member 30. In some embodiments, the force application member 30 may include a suture stopper. For example, the force application member 30 may be crimped or clamped at or near its proximal end while the sutures 40A-D are located therein. Such crimping may cause the force application member to clamp the sutures and act as a suture stopper. In further embodiments, the force application member may include a stop structure, such as a hook or a thin notch, for engaging the sutures to thereby secure the sutures to the elastic member. For example, a thin slot or notch may be cut at an angle to the tube axis at the proximal end of the tube wall of the force application member 30. The sutures 40A-D may slide into the notch to inhibit their movement relative to the force application member 30. Similarly, the force application member 30 may include a hook or other structure for winding or tying the sutures 40A-D to thereby secure them to the force application member 30.

[0099] Those of ordinary skill in the art will understand that the level of tension on the suture 40 can be changed in a variety of ways. The tension on the suture 40 may be affected by at least the following factors: the relative strength of the elastic member 90; the spring constant of the elastic member 90 (e.g., if it is a spring); the relative lengths of the sutures 40A-D, the tensioning tube 20, the elastic member 90, and the force application member 30; the type of suture material (e.g., the amount of stretch of the suture material); the position of the elastic member stopper 70 within the tensioning tube 20; the adjustment of the force application member 30 by the user (in an adjustable tension configuration); and so on. In the various embodiments described herein, the tension applied to the sutures 40A-D may be within various ranges, such as 0.1 to 4 pounds, 0.1 to 2 pounds, 0.25 pounds to 2 pounds, or others. The required tightening force may depend on the specific application. For example, the required tightening force for the femoral artery and femoral vein may be different because the intravascular pressures may be different.

[0100] Returning to Figure 1-Figure 2 , the distal end 22 of the tensioning tube 20 optionally includes a suture lock 60. The suture lock 60 may hold the sutures 40A-D in a tensioned state to permanently close the access site when additional access to the vascular lumen is no longer needed and the tensioning tube 20 has been removed. Additionally and / or optionally, the suture lock may be placed on the sutures 40A-D after the sutures 40A-D have been removed from the tensioning tube when additional access to the vascular lumen is no longer needed. Such permanent or semi-permanent closure may allow the access site to heal and prevent rebleeding before healing is complete. As Figure 2As shown, the suture lock 60 can be a ferrule that is slidably sleeved over the sutures 40A-D. The ferrule can be crimped so that it is tightened and clamped onto the suture, thereby securing it in place. Optionally, the suture lock 60 can contact the tensioning tube 20, but can still be crimped when the tensioning tube is in place, thereby securing the sutures 40A-D in the tensioned position. After crimping the suture lock 60, the user can cut the sutures 40A-D at the proximal end of the suture lock 60. This will separate the anchors 50A-D, the distal ends of the sutures 40A-D, and the suture lock 60 from the rest of the dynamic vascular access and closure device 10 and permanently close the access site. The locking mechanism (e.g., suture lock) can be separate from or integrated with any component of the device 10. They can be removably or fixedly mounted on the device 10 (and / or its components) and / or other devices. In some examples, the suture lock is disposed at or near the distal end of the tensioning tube 20 and can be advanced along the tensioned suture to a position between the distal end of the tensioning tube and the access point. The advanced suture lock optionally provides an additional inward radial tightening force on the anchored suture. Optionally, the suture lock is included on and / or is advanceable on the tensioning tube 20 and / or the suture so that the suture lock can be properly positioned on the suture to be locked.

[0101] As described herein, the suture lock 60 can take any existing or future form without departing from the principles of the present disclosure. Figure 6A Such examples of the suture lock 60 are shown. Figure 6A An alternative suture lock having an open position 600 and a closed position 620 is shown. As shown in the side view and top view, the suture lock can include an inner body 602 and a housing 604 disposed around the inner body 602. The inner body 602 can be slidably connected to the housing 604. The housing 604 can include holes 608 that pass through the top and bottom of the housing 604. The inner body 602 can include a hole 612 that passes completely through the inner body 602. In the open position 600, the holes 608 can be coaxially aligned with the hole 612 to allow the suture to pass through the suture lock. The housing can include a lasso 606 that can be used to move the inner body 602 relative to the housing 604, thereby placing the suture lock in the closed position 620. When the lasso 606 is pushed and laterally moved to the axis of the hole 612, it can cause the inner body 602 to move laterally relative to the housing 604. Thus, in the closed position 620, the holes 608 and 612 may be misaligned. This misalignment can clamp the suture between the inner body 608 and the housing 612, thereby locking the suture in place and preventing the suture lock from moving along the suture.

[0102] Figure 6BIllustrate other exemplary suture locks. For example, suture locks 630 and 640 are two-component optional suture locks with two channels through which the suture can pass. When the two-component lock is in the closed position, the two locking members will clamp the suture and prevent the suture from slipping out of the lock. In the open configuration, the channels are aligned and the suture can move freely. When in the closed configuration, the channels may be misaligned, preventing the suture from moving freely. In some embodiments, if re-entry into the access site is required after tightening the suture lock, the suture lock can be unlocked to allow the suture to move freely. Lock 630 includes two separate suture holes, while lock 640 includes a single hole through which the suture can pass.

[0103] Figure 6B Lock 650 in [description] illustrates a three-component suture lock design. Lock 650 includes a body 652 with two holes that allow the suture to pass through freely. A stop element 654 can move within the channel to prevent the suture from moving freely. The stop element can be moved from the closed position to the open position by an adjustment knob 656. Although lock 650 shown in the figure has two suture holes, more or fewer suture holes can be used.

[0104] Suture locks can also be of other types. For example, suture locks can also be in the form of a single-piece, single-channel lock, such as a metal ferrule that is irreversibly crimped at the end of the surgery to lock the distal end of the suture under tension.

[0105] Figure 7 Illustrate various exemplary arrangements of suturing on the blood vessel wall consistent with the disclosed embodiments. Examples 170, 180, and 190 illustrate non-anchored suture arrangements. As Figure 7 shown, a non-anchored suture connection can include a suture loop running within the blood vessel. In the case of arrangement 170, suture filaments 172 can be laterally spaced on the blood vessel surface with entry / exit points 174, 176. The distance between these points can vary depending on, for example, the size of the blood vessel, the size of the suture, the size of the interventional device introduced into the blood vessel lumen, etc. The suture can be looped around the blood vessel such that when the free end of the suture outside the blood vessel is pulled, the entry points of the suture are pulled together, closing the entry opening between the two entry points. Example 180 depicts a four-point closure arrangement using two sutures. Two sutures 182, 184 can each have laterally spaced entry / exit points. The two sutures can also be axially spaced along the blood vessel. For example, in configuration 180, entry holes 186, 188 are axially spaced on the blood vessel. The lateral spacing between the entry / exit points of the two sutures can be substantially the same. Similarly, the axial spacing between the two sutures can be substantially the same as the lateral spacing between the entry and exit, such that the four pull points of the sutures form a square on the blood vessel. Figure 7The exemplary configuration 190 therein is a six - point closure structure using three sutures. As with structures having fewer points, the points of each suture can also be laterally spaced apart. For example, the entry points 192, 194 of the middle suture in configuration 190 are laterally spaced apart. Additionally, the outer sutures of configuration 190 can be spaced along the main axis of the blood vessel. As shown in arrangement 190, even if the number of connection points to the blood vessel exceeds four, the tensioning tube 20 assembly can still be maintained at the center of the connection points to ensure proper closure and apply substantially equal tension to each suture. Although the drawings typically depict symmetric arrangements of sutures, these arrangements are not necessarily symmetric. Additionally, although Figure 7 arrangements with 2, 4, or 6 sutures are shown, other numbers of sutures (including an odd number of sutures) can also be used.

[0106] Figure 7 Examples of anchor - based suture arrangements are also illustrated. For example, instead of using a single suture that passes through the blood vessel and exits at another point in the blood vessel, multiple sutures can be used, with an anchor provided at the distal end of each suture. As described herein, the anchor can be attached to the blood vessel wall. The sutures can then be tightened, pulling the anchored ends together and closing the blood vessel opening or access site. In exemplary arrangement 200, two sutures 202, 204 are used together with anchors 206, 208 respectively. The anchors 206, 208 are placed on the transverse axis passing through the blood vessel and are spaced apart along that axis. Arrangement 210 uses four anchors 212, 214, 216, 218, which are spaced in a square pattern, each anchor having its own connecting suture. Similarly, arrangement 220 uses six anchors. In some embodiments, as shown in arrangement 220, the arrangement can have more than four anchors but still have a substantially square form. In this case, even though two additional anchor points are provided between anchors 222, 226 and anchors 224, 228, the spacing between the corner anchors 222, 224, 226, 228 is substantially the same, thus forming a square. As with the non - anchor suture forms described above, symmetric anchor forms can allow the tensioning tube 20 assembly to be positioned at the center of the anchor points to ensure proper closure and make the tension on each suture substantially equal. Other suture arrangements and numbers of sutures (e.g., circular, star - shaped, etc.) are also within the scope of the present disclosure.

[0107] The choice of suture arrangement may depend on, for example, the size of the blood vessel to be accessed and / or the size of the interventional device used. Larger blood vessels and dilators may pose a greater potential bleeding risk to the patient. Smaller blood vessels may also have limited space for accommodating sutures or anchors, thereby restricting the number or type of suture arrangements. For example, a large catheter of 24 - 30 French may require, for example, a six - anchor arrangement such as 220. Smaller catheters, such as those of 12 - 24 French, may require fewer anchors, such as a four - anchor arrangement 210. Even smaller catheters (e.g., 6 - 12 French catheters used in certain arterial applications) may only require a linear two - suture pattern, such as arrangement 200.

[0108] Figure 9 FIG. is a flow chart depicting an example method 900 of using the dynamic vascular access and closure device 10 of the present disclosure. In step 910, the anchors and / or sutures can be deployed into the vessel wall using any currently or hereafter known deployment device. Step 910 can also include deploying a guide wire. In this step, the dynamic vascular access and closure device can tension the guide wire and / or the sutures around the access site or hole in the blood vessel.

[0109] In step 920, method 900 can include inserting an interventional device into the blood vessel through the guide wire. In other embodiments, the sutures and the tensioning device can be deployed prior to vascular access. Thus, the anchors can be placed without a guide wire and the guide wire can be inserted after the placement device. As described herein, when the interventional device is inserted, the sutures may shift or be pulled, thereby dilating the access site in the blood vessel. The force applied by the interventional device to the sutures causes the elastic member within the tensioning tube to compress (or stretch in applicable embodiments). The force exerted by the elastic member on the sutures will keep the anchors close to the device, thereby sealing the vessel wall around the device and preventing or reducing any unnecessary bleeding. In step 930, the interventional device can be withdrawn from the blood vessel. When the device is withdrawn, due to the decompression of the elastic member, the access hole is automatically closed by the sutures, thereby pushing the suture stop device and causing the sutures to tighten together. This automatic closure function of the access site prevents bleeding when the interventional device is removed from the blood vessel. This automatic hemostasis technique is a significant improvement over the prior art because the user does not need to manually pinch the blood vessel to prevent bleeding. Sometimes, a doctor may need to use a cross - balloon, which can be inserted from another access site and temporarily inflated to stop bleeding. The automatic tightening function provided by the embodiments of the present invention can reduce the need for such a technique. Thus, by using the dynamic vascular access and closure device, the surgeon can perform the operation more easily and the patient is safer.

[0110] As described herein, the dynamic vascular access and closure device 10 of the present disclosure also allows for reinsertion of an interventional device through the same access site. Thus, method 900 may include determining in step 940 whether an additional interventional device needs to be inserted. If an additional interventional device needs to be inserted, step 920 may be repeated. If an additional interventional device does not need to be inserted, step 950 may be performed. In step 950, the suture lock may be locked. As described herein, the suture lock may be locked by crimping a ferrule or locking an optional lock, etc. In step 960, the suture may be cut. The suture may be cut at any desired location, such as at the distal end of the tensioning tube between the tensioning tube and the suture lock, so as to keep the amount of additional suture connected to the patient's blood vessel relatively minimal. Thereafter, the tensioning tube assembly may be removed. In other embodiments, the suture may be cut at the proximal end of the elastic member, leaving a relatively long additional suture extending out of the suture lock between the elastic member and the suture stopper (which may be used to tie a knot at the end of the suture lock to provide additional security against suture unraveling).

[0111] Figure 8 Intuitively illustrate the process of using the dynamic vascular access and closure device 10 to access the vascular lumen through the access site as described above. Figure 8 The example in shows four anchor-based sutures connected to the blood vessel around the access site 800. Illustration 801 shows four sutures (collectively 840) anchored to the blood vessel wall by anchors (collectively 850), while the access site 800 is tightened and closed. The sutures 840 extend through the suture lock 860 and the tensioning tube 820 (including the above components). Arrows 832 and 834 show the direction of the tightening force exerted by the sutures around the access site. As described above, this force may be a radial force that pulls each anchor 850 towards the access site located between the anchors. Arrow 836 shows the direction of the reaction force acting on the tensioning tube, which pushes the tensioning tube towards the blood vessel wall. Although Figure 8 shows a configuration in which the anchors 850 are substantially symmetric with respect to the access site, the present disclosure is not so limited, and the anchors may be placed in any suitable position. When the anchors are placed in a substantially symmetric arrangement and the suture lengths are approximately the same, the tensioning tube 820 is located at the center between the anchors, such that substantially equal tension is applied to the sutures. In some embodiments, during anchor deployment, a guide wire (not shown) may be inserted into the access site 800. Then, the guide wire may be used to guide the insertion of an interventional device into the access site. Optionally, the guide wire may not be present, and the tensioning tube 820 may be used as a positioning tool to guide the interventional device towards the access site (as shown by 840).

[0112] Illustration 802 shows that interventional device 842 is being inserted into the blood vessel lumen through access site 800. When interventional device 842 is inserted into access site 800, the diameter of access site 800 increases, causing suture 840 to be tightened. At this time, the elastic member in tensioning tube 820 is compressed to maintain the tension of suture 840, thereby closing the blood vessel wall around interventional device 842 and ensuring that there is no external bleeding around interventional device 842.

[0113] When interventional device 842 is removed from access site 800, the elastic member in tensioning tube 820 will expand, pulling sutures 840 toward each other, thereby closing access site 800 as shown at 803. The interventional device (same or different) can then be reinserted into the access site using the steps shown at 802.

[0114] When the procedure is complete and access to the vessel lumen is no longer required, the access site 800 can be more permanently closed using a suture lock 860. As described herein, the suture lock 880 can be crimped or otherwise locked. The suture can then be cut, releasing the tension tube 820 assembly. Thus, as shown at 804, the anchor 850, the distal end of the suture 840, and the suture lock 880 remain to keep the vessel opening closed. If a guide wire was used during the procedure, it can also be removed before locking the suture lock 860.

[0115] The various figures and embodiments discussed below illustrate various methods for providing dynamic tension to close the access site for the suture. These embodiments allow the installation of suture anchors and sutures when the sutures are loose, which can also allow, for example, large sheaths and catheters to be installed in the access site without worrying about cutting, severing or breaking the pre-tensioned sutures. Optionally, the embodiments described below allow greater tension or tightening forces to be applied to the sutures. In addition, the sutures can be loosened any number of times so that the interventional device can be inserted or reinserted into the access site without causing the sutures to break due to the potential additional force on the tensioned sutures. Since the sutures can be dynamically tensioned, greater tension can also be applied. The tension of the sutures can vary according to the size, application, type of elastic member, etc. of the sutures. For example, a force of about 1 to about 2 pounds can be applied to each suture. For another example, a force of about 1.5 pounds can be applied to each suture. As previously described, a greater or lesser force can be applied according to the specific application of the disclosed embodiments. Each of the embodiments described below can be implemented in combination with the aforementioned embodiments.

[0116] FIG. 10 is a perspective view of an alternative arrangement of an exemplary dynamic vascular access and closure device. Figure 10A , Figure 10B and Figure 10CAs shown, the dynamic vessel access and closure device 1000 includes a tensioning tube 1020 having a distal end 1022 and a proximal end 1024. The distal end 1022 is the working end close to the blood vessel. One or more sutures 1040A-D (also interchangeably referred to as sutures or suture threads) axially extend through the tensioning tube 1020 between the distal end 1022 and the proximal end 1024, and the distal end of each suture is connected to a suture anchor (not shown). The elastic member and applicator 1012 are at least partially disposed within the tensioning tube 1020.

[0117] As shown in the figure and as described above with respect to other embodiments (e.g., with respect to Figure 1 -5 shown and described embodiments), the tensioning tube 1020 includes an elongated hollow tubular outer shaft that defines a lumen through which other components can pass or be placed. Although the tensioning tube 1020 shown in the figure has a circular cross-section, other cross-sections, such as square, rectangular, oval, etc., are also within the scope of the present disclosure. The lumen may include a first portion with a diameter smaller than a second portion. The smaller diameter of the first portion is large enough to allow the sutures 1040A-D to pass freely. The larger diameter of the second portion is large enough to accommodate the elastic member and the applicator 1012.

[0118] In various embodiments, the tensioning tube 1020 may include an elastic member stopper 1070. The elastic member stopper 1070 can take various forms, for example, a step defined by the tensioning tube diameter changing from a larger lumen diameter to a smaller lumen diameter (as shown in FIG. 10), the tensioning tube 1020 tapering gradually from a larger lumen diameter to a smaller lumen diameter, a pin or other structure passing through the lumen and orthogonal to the main axis of the tensioning tube 1020, or other suitable forms. As described above, the tensioning tube 1020 can be made of various materials, such as polymers (e.g., plastics, rubbers, etc.), metals or alloys (e.g., titanium, stainless steel), or any other suitable material having sufficient stiffness to prevent deformation under the compressive load applied by the tensioned sutures 1040A-D.

[0119] The applicator 1012 can be an internally biased tube that is at least partially disposed within the lumen of the proximal end 1024 of the tensioning tube 1020 such that the distal end of the applicator can be located within the lumen while the proximal end is outside the lumen. In various embodiments, the applicator 1012 can be a hollow tube. The applicator 1012 can move freely relative to the tensioning tube 1020. Although the applicator 1012 shown in the figure has a circular cross-section, other cross-sectional shapes, such as square, rectangular, oval, or other shapes, can also be used. The applicator 1012 and the tensioning tube 1020 can have similar or different cross-sectional shapes. The applicator 1012 can also be made of various materials, such as plastics or metals, having sufficient stiffness to prevent deformation under the compressive load applied by the tensioned sutures 1040A-D.

[0120] As Figure 10B-10C shown, the elastic member 1090 may be disposed within the tensioning tube 1020, between the elastic member stop 1070 and the distal end of the applicator, as described in more detail above. In various embodiments, the elastic member 1090 may be a helix, such as a spring and / or other type of elastic member that can be compressively abutted against the elastic member stop 1070. For example, the elastic member 1090 may be an elastic tube or other structure that can be repeatedly compressed and decompressed when an axial force is applied at one or both ends thereof, such as, but not limited to, an air spring, a hydraulic / gas spring, a motor, or any elastic member known now or hereafter. For example, the elastic member may be a linear actuator for tensioning the sutures 1040A-D.

[0121] In various embodiments, the applicator 1012 may be held in a first position by the tension lock 1050. Exemplary tension locks will be described in more detail below and are configured to hold the applicator 1012 relative to the tensioning tube 1020 in one or more positions. For example, the tension lock 1050 may hold the applicator in Figure 10B the first position shown such that the elastic member is in a compressed state. By compressing the elastic member, the sutures 1040A-D can be relaxed. This initial relaxation of the sutures has several advantages. This relaxation can allow a large-sized sheath to be placed in the blood vessel between the sutures while reducing the risk of suture breakage or cutting. Once the large-sized sheath is inserted into the blood vessel and tension needs to be applied to the sutures (e.g., for closing the access site), the tension lock can be manipulated (e.g., the bridging structure can be cut or otherwise disrupted), causing the elastic member to expand, which in turn causes the applicator 1012 to move proximally towards the second position and tighten the sutures. As described in more detail below, the tension lock 1050 can take various forms, such as a frangible bridge, a suture bridging structure (also referred to as a trigger suture), a reversible mechanical structure (e.g., a combination of a rotatable pin and slot). These variants will be discussed in more detail below in connection with Figure 11A-13B more detail. The relaxation of the sutures should be sufficient to easily insert the large-sized sheath. In some embodiments, the relaxation may be the suture length that is at least about half the circumference of the sheath to about 3 inches. Other embodiments may include a suture length corresponding to a relaxation of about 1 inch to about 4 inches.

[0122] In Figure 10B 、 10C, in the specific examples of 11A and 11B, the tension lock 1050 includes an end cap 1010 connected to the proximal end of the applicator 1012 and a frangible bridge 1015 extending distally from the end cap 1010 and connected to the proximal end of the tensioning tube 1020. Optionally, a suture knot 1045 or a similar connector can be provided to hold or otherwise connect the proximal ends of the sutures 1040A-D within the end cap 1010 such that movement of the end cap proximally causes the sutures to be tensioned. The frangible bridge can be made of a suitable polymer, metal, or other suitable material. During the installation of the suture anchor and the initial access site (e.g., the introducer sheath), the dynamic vessel access and closure device 1000 is configured to be in a first state in which the tension lock is configured to hold the elastic member in a compressed state, thereby causing the sutures to be slack. Specifically, when the bridge 1015 is intact, it is configured to hold the applicator in a first position, thereby causing the elastic spring to be compressed (as Figure 10B and Figure 11A shown), and shortening the length of the sutures fixed within the tensioning tube (thereby causing the sutures around the access site to be slack).

[0123] When the user is ready to tighten the sutures, as Figure 10C and Figure 11B shown, the bridge 1015 can be disconnected, thereby placing the dynamic vessel access and closure device 1000 in a second state in which the sutures anchored around the access site are tightened. When the bridge 1015 is disconnected, the applicator is no longer restricted to its first position, thereby releasing the compressive force within the elastic member and causing the applicator to move to a second position (as Figure 10C and Figure 11B shown). Specifically, when the bridge is disconnected, the compressed elastic member can at least partially expand such that the spring force stored in the compression spring causes the end cap (and the applicator) of the tension lock to move to a second position (as Figure 10C and Figure 11B shown), which in turn causes the anchored sutures to be tightened (due to the pulling force of the proximal ends of the sutures in the proximal direction). In Figure 10C and Figure 11B , the movement of the end cap 1010 and the applicator 1012, as well as the creation of the gap 1017 and the resulting tension, can be seen. In some embodiments, the bridge 1015 can break into multiple parts 1050A and 1050B. In this example, the bridge can be broken by cutting (e.g., using a knife, scissors, scalpel, or other blade), breaking, or twisting (e.g., by hand or using a tool such as a hemostat). In various embodiments, the bridge can be manually broken (e.g., directly cut with a scalpel) or automatically broken (e.g., by a machine or electronic device or by the user pressing a button to break the bridge).

[0124] Figure 12AA side view of an alternative arrangement of the exemplary dynamic vessel access and closure device 1200 in a first state; Figure 12B The device is then shown in a second state. In the present embodiment, the outer elastic member 1210 (illustrated as a compression spring) has a distal cap 1212 and a proximal cap 1214. The elastic spring 1210 is mounted on the smaller diameter portion 1216 of the tensioning tube 1220 because mounting the elastic member 1210 allows for the use of a larger spring as the elastic member 1210. The remainder of the tensioning tube assembly may remain the same, but the size of the elastic member 1210 (and thus the resulting tightening force) may be adjusted. In some embodiments, the larger diameter distal portion of the tensioning tube 1220 may be made of an axially flexible material, such as a polymer, to provide flexibility around the access site without concern for distortion or bending of a rigid metal tube. In contrast, the smaller diameter proximal portion 1216 may be made of a stiffer material, such as a metal like a higher rigidity stainless steel. One or more sutures extend between the distal and proximal ends of the tensioning tube and may protrude from the proximal end to form suture knots 1226. The suture knots 1226 may be formed externally proximal to the proximal cap 1214 such that compression / expansion of the spring causes movement of the suture knots, thereby tightening or loosening the sutures. An optional sheath may cover the elastic spring and / or Figure 12A and Figure 12B other components of the device shown (not shown here). Although Figure 12A and Figure 12B the dynamic vessel access and closure device 1200 in contains an outer spring design, the present disclosure is not limited thereto, and similar tension locks may be used in other embodiments of the present disclosure. Similarly, the above-described tension locks may be used in conjunction with the outer spring configuration of the dynamic vessel access and closure device.

[0125] The tension lock 1218 is in the form of a trigger suture that extends from the distal cap 1212 to the proximal cap 1214 (i.e., from the suture knot or stop 1222 to 1224). The tension lock 1218 holds the elastic member 1210 in a compressed position. The suture length of the tension lock 1218 will control the amount of compression applied to the elastic member 1210 (i.e., a shorter suture will result in greater compression and relaxation, while a longer suture will result in less compression and relaxation, thereby reducing the relaxation of the sutures used to close the access hole (shown by the suture knot or stop 1226)). During the installation of the suture anchor and the initial access site (e.g., installation of the sheath), the dynamic vessel access and closure device 1200 may be maintained in the first state (as Figure 12A shown), where the tension lock is configured to hold the elastic member in a compressed state, resulting in a shorter length of the sutures within the tensioning tube and thus causing relaxation of the sutures near the vessel access site.

[0126] The proximal cap 1214 may include a window 1228 that may expose a portion of the tension lock suture 1218. Thus, when a user desires to release the tension lock suture 1218 and tighten the access site suture, the tension lock suture 1218 may be cut or otherwise disengaged through the window 1228, as Figure 12B shown. When the suture is cut or disengaged, the compressed elastic member will at least partially expand such that the spring force stored in the compression spring causes the proximal cap 1214 and the suture knot 1226 to move to a second position (as Figure 12B shown). As the length of the suture within the tensioning tube increases, this in turn causes the anchor suture around the access site to be tightened. Figure 12B The elongation of the elastic member 1210 can be seen in Figure 12A and, less visibly, 10 degrees (compared to

[0127] Figure 13A is a perspective view of an alternative arrangement of an exemplary dynamic vessel access and closure device 1300 in a first state. Figure 13B is a perspective view of an alternative arrangement of an exemplary dynamic vessel access and closure device 1300 in a second state. The dynamic vessel access and closure device 1300 includes an external elastic member design similar to that of the dynamic vessel access and closure device 1200 in Figure 12A-12B . However, the tension lock may be used with any embodiment of the present disclosure.

[0128] In this example, the elastic member 1310 is placed around a tensioning tube (not shown here). Additionally, the tension lock 1350 includes an inner tube 1312 coupled to the distal end of the elastic member 1310. The control tube section 1316 is slidably disposed around the outer tube 1314. The control tube section 1316 is also rigidly connected to the inner tube 1312. Thus, the outer tube 1314 acts as a guide rail for the sliding of the control tube section 1316. Since the control tube section 1316 is fixed at the proximal end of the elastic member 1310, when the control tube section 1316 moves in the proximal direction (i.e., away from the entry site and towards the end cap 1318), the elastic member 1310 is compressed. This compression causes the suture to slacken. Specifically, when the control tube section moves proximally, the tensioning tube actually shortens, reducing the length of the suture within the tensioning tube. The shortening of the suture length within the tensioning tube causes the suture around the entry site to slacken. Conversely, when the control tube section 1316 moves distally (i.e., towards the entry site and away from the end cap 1318), the elastic member 1310 expands and applies tension to the suture closing the entry site. The suture 1328 is located within the inner tube, and its proximal end may be provided with a knot or stopper 1326 that can contact the end cap 1318. The end cap 1318 may be fixed around the proximal end of the outer tube 1314.

[0129] The suture bridge tension lock 1320 can hold the control tube section 1316 in a first retracted position. For example, the tension lock 1320 is in the form of a trigger suture that extends from the end cap 1318 to the proximal end of the control tube section 1316 (i.e., from the knot or stopper 1322 to 1324). Thus, during the installation of the suture anchor and the initial entry site (e.g., the installation of the sheath), the dynamic vascular access and closure device 1300 can be held in a first position (as Figure 13A shown), in which the tension lock 1320 is configured to hold the elastic member 1310 in a compressed state, thereby slackening the suture. The suture length of the tension lock 1320 will control the amount of compression experienced by the elastic member 1310 (i.e., a shorter suture will result in more compression and more slack, while a longer suture will result in less compression and less slack of the suture 1328).

[0130] When the user wishes to release the tension lock 1320 and tighten the suture at the entry site, the tension lock suture 1320 can be cut or otherwise disconnected, for example, at the exposed portion between the end cap 1318 and the control tube section 1316. When the user is ready to tighten the suture, as Figure 13B shown, the bridging is disconnected. When the bridging is disconnected, the compressed elastic member can at least partially expand, causing the suture knot to move proximally, thereby increasing the length of the suture within the tensioning tube and increasing the tension of the anchor suture around the entry site. Figure 13BThe tension generated when the control tube section 1316 (remote from the end cap 1318) moves distally can be seen. If the user wishes to release the tension on the suture 1328, the control tube section 1316 can simply be pulled proximally towards the end cap 1318, compressing the elastic spring and shortening the length of the suture within the tensioning tube, thereby causing the anchor sutures around the entry site to slacken. Thus, the device 1300 also has the additional advantage that the suture slack can be easily increased after initial installation.

[0131] Figure 14A FIG. 4 is a perspective view of an alternative arrangement of an exemplary dynamic vessel entry and closure device 1400 in a first state. Figure 14B FIG. 5 is a perspective view of an exemplary dynamic vessel entry and closure device 1400 in a second state. Figure 14C FIG. 6 is a perspective view of an exemplary dynamic vessel entry and closure device 1400 in a third state. The dynamic vessel entry and closure device 1400 includes an easily reversible tensioning system using pins and slots. The dynamic vessel entry and closure device 1400 includes a tensioning tube 1420 and an applicator 1412. An elastic member 1490 is disposed within the tensioning tube 1420 and is engageable with an elastic member stop 1470. Sutures 1440A-D axially pass through the tensioning tube 1420 and may terminate at the proximal end 1495 of the elastic member 1490. In other embodiments, the proximal ends of the sutures 1440A-D may be connected to the applicator 1412. The tensioning tube 1420 includes a slot or recess 1430 extending axially along its length at or near its proximal end. The slot 1430 is sized and shaped to receive a pin 1425 or projection extending from the applicator 1412. At the distal end of the slot 1430, the tensioning tube 1420 may include a pin stop or catch 1435, which may be a flat or recessed area for securing the pin 1425. In Figure 14A the first position shown, the pin stop 1435 holds the pin 1425. In this position, the applicator 1412 is held in a distally forward position by the pin 1425, thereby compressing the elastic member 1490 and causing the sutures 1440A-D to slacken. When the user desires to tension the sutures 1440A-D, the user can place the device 1400 and the tension locking mechanism in a second position and rotate the applicator 1412 until the pin 1425 aligns with the slot 1430, as Figure 14B shown. Then, the elastic member 1490 expands as the pin 1425 slides along the slot 1430, tensioning the sutures 1440A-D until the pin 1425 reaches the proximal end of the slot 1430. The resulting third position is as shown in Figure 14CAs shown. This easy - to - use rotary - sliding pin mechanism allows the user to add slack to the suture 1440A - D by simply pushing the proximal end of the applicator 1412 until the pin 1425 exits the slot 1430 and then rotating the applicator 1412 until it clears the slot. This action returns the device to the initial position (as Figure 14A shown), enabling the device to hold the slack on the suture without the user having to grip a part of the device (i.e., by continuously manually compressing the elastic member).

[0132] Although some of the above - described embodiments include different tensioning mechanisms (e.g., external spring vs. internal spring design), any tensioning mechanism can be configured to work with the various disclosed suture tension locks.

[0133] Figure 15A is a flowchart depicting an example method 1500 of using the dynamic vascular access and closure devices 1000, 1200, 1300, 1400 of the present disclosure. Additionally, Figure 15B-Figure 15H shows the various steps of method 1500 of using the dynamic vascular access and closure device 1000, but method 1500 can be implemented using the various devices described above. In step 1510, an anchor and / or suture can be deployed into the vessel wall using any presently or hereafter known deployment device. Step 1510 can also include deploying a guide wire. In this step, the dynamic vascular access and closure device can tension the suture around the guide wire and / or the access site or hole in the vessel. Figure 15B is a schematic view of step 1510, showing the situation after the suture anchors 1042A - D have been deployed through a deployment tube around the access site 1004 in the vessel 1002. Figure 15C shows the suture 1040A - D and the guide wire 1006 in a slack state after installation. The suture extends through the tensioning tube 1020.

[0134] In step 1520, method 1500 can include inserting an interventional device (e.g., a sheath) into the vessel through the guide wire. In other embodiments, the suture and tensioning device can be deployed before vessel access. Thus, the anchor can be placed without a guide wire, and the guide wire can be inserted after the device is placed. As described herein, when the interventional device is inserted, the suture may shift or be pulled, thereby dilating the access site in the vessel. The force applied by the interventional device to the suture causes the elastic member within the tensioning tube to compress (or stretch in applicable embodiments). The force exerted by the elastic member on the suture will hold the anchor close to the instrument, thereby sealing the vessel wall around the instrument and preventing or reducing any unnecessary bleeding. In other embodiments, as Figure 15DAs shown, prior to and during the insertion of the intervention device 1008, the sutures 1040A-D may be slack. As described above, this can enable the installation of the intervention device 1008 without the risk of cutting or breaking the sutures 1040A-D. Since the sutures 1040A-D are slack, the access site 1004 can be allowed to expand, thereby enabling the intervention device 1008 to enter the blood vessel 1002.

[0135] In step 1525, method 1500 may include tightening the sutures, for example, by releasing the tension locks as described above with respect to any of the dynamic vessel access and closure devices 1000, 1200, 1300, 1400. Figure 15E The tightened sutures 1040A-D are shown, closing the access site 1004 around the intervention device 1008.

[0136] In step 1530, the intervention device may be withdrawn from the blood vessel. When withdrawing the instrument, due to the decompression of the elastic member, the access hole will be automatically closed by the sutures, which in turn will push the suture stop device and cause the sutures to tighten together. This automatic closure function of the access site can prevent bleeding when the intervention device is removed from the blood vessel. This automatic hemostasis technique is a significant improvement over the prior art because the user does not need to manually pinch the blood vessel to prevent bleeding. In other cases, the doctor may need to use a crossover balloon, which can be inserted from another access site and temporarily inflated to stop bleeding. The automatic tightening function provided by the embodiments of the present invention can reduce the need for such techniques. Therefore, by using the dynamic vessel access and closure device, the procedure is easier for the surgeon and safer for the patient. Figure 15F Step 1530 is shown, in which the intervention device 1008 is removed along the guidewire 1006. As shown, the tension on the sutures 1040A-D causes the access site 1002 to tightly close around the guidewire 1006.

[0137] As described herein, the dynamic vessel access and closure devices 1000, 1200, 1300, 1400 of the present disclosure also allow for the reinsertion of an intervention device through the same access site. Therefore, method 1500 may include determining in step 1540 whether an additional intervention device needs to be inserted. If an additional intervention device needs to be inserted, then method 1500 may include step 1545 of loosening the sutures (e.g., to prevent the sutures from being cut or broken during the insertion of the additional device). Loosening the sutures in step 1545 may include slackening the sutures by, for example, manually compressing the elastic member (or other methods disclosed above). After loosening the sutures, step 1520 may be repeated. Figure 15G The loosened sutures 1040A-D are shown, allowing the access site 1006 to expand to receive the intervention device 1008 inserted into the blood vessel 1002.

[0138] If no additional intervening device needs to be inserted, step 1550 can be performed. In step 1550, the suture lock can be locked. As described herein, the suture lock can be locked by means such as a crimp ferrule or a locking optional lock. In step 1560, the suture can be cut. The suture can be cut at any desired location, such as at the distal end of the tensioning tube between the tensioning tube and the suture lock, so as to keep the amount of additional suture connected to the patient's blood vessel to a relatively minimum. Then the tensioning tube assembly can be removed. Figure 15H Illustrates a locking suture lock 1060 around sutures 1040A-D. In this example, the suture lock 1060 is a ferrule that is crimped around the cut sutures 1040A-D. In other embodiments, the suture can be cut at the proximal end of the elastic member, leaving a longer additional suture extending from the suture lock between the elastic member and the suture stopper (which can be used to tie a knot at the end of the suture lock to provide additional security against suture unraveling).

[0139] Figure 16 Is a perspective partial exploded view of an alternative arrangement of the exemplary dynamic vascular access and closure device 1600 in a first position. Figure 17 Is a perspective view of an alternative arrangement of the exemplary dynamic vascular access and closure device 1600 in a second position. As Figure 16 and Figure 17 shown, the dynamic vascular access and closure device 1600 includes a tensioning tube 1620 having a distal end 1622 and a proximal end 1624. The distal end 1622 is the working end placed near the blood vessel. One or more suture filaments 1640A-D (also interchangeably referred to as sutures and sutures) axially extend from the distal end 1622 to the proximal end 1624 through the tensioning tube 1620, and the distal end of each suture is connected to a suture anchor (not shown).

[0140] The proximal end 1624 of the tensioning tube 1620 includes a protrusion 1630. The protrusion 1630 can take various shapes and sizes. For example, as shown, the protrusion 1630 can be a hub having three planes and a rounded edge. In other embodiments, the protrusion 1630 can be a circular hub having a circular cross-section. In further embodiments, the protrusion 1630 can be a pin or a protrusion that does not extend to cover the entire surface of the tensioning tube 1620. Each of the plurality of sutures 1640 axially extends through the body of the tensioning tube 1620 and can be connected to a suture anchor 1635. The suture anchor is configured to connect each of the plurality of sutures to a rod 1660 of a spring assembly, as described in more detail below.

[0141] The dynamic vessel access and closure device 1600 also includes a spring assembly 1610. The spring assembly may have a body 1650 that can serve as a housing for other components such as a spring 1655. The distal end of the body 1650 may include a channel 1645 that is configured (i.e., sized and shaped) to receive a protrusion 1630 of the tensioning tube 1620. The body 1650 may also include a longitudinal slot 1665. The longitudinal slot may open on the top surface of the body such that the proximal portion of the tensioning tube and the proximal portion of each suture can be placed in the body through the slot. The axial slot may also expose a longitudinal channel. The longitudinal channel may be configured to receive an elongate rod 1660. The rod 1660 may be at least partially disposed within the body 1650 and connected to the spring 1655. As shown, the spring 1655 may be a constant force spring. Other types of springs are also feasible, such as a helical tension spring or a compression spring. In some embodiments, the spring 1655 may be a motor. The rod 1160 may also include a pin 1662. The pin 1662 may be connected to the spring 1655, such as through a hole in the spring or other suitable connection means. The rod 1660 may also include a recess 1670 that is configured to engage a suture anchor 1635. The suture anchor 1635 may include a protrusion that is configured to be received by the recess 1670.

[0142] When the user desires to connect the suture and the tensioning tube to the spring assembly 1610 (i.e., after the suture has been anchored in the vessel and the suture needs to be tensioned), the protrusion 1630 of the tensioning tube can be pressed into the channel 1645 of the body 1650 of the spring assembly 1610. The proximal end of the suture 1640 can be placed in the spring assembly 1610 through the slot 1665 and connected to the rod 1660 by engaging the suture anchor 1635 with the recess 1670 of the rod 1660. Thus, the proximal end of each of the plurality of sutures 1640 can extend through the longitudinal slot 1665 of the body 1650 of the spring assembly 1610 and be connected to the rod 1660. Accordingly, the proximal portion of the rod 1660 can extend out of the body 1650 such that the suture anchor 1635 does not interfere with the body 1650. The proximal extension of the rod 1660 also provides a surface for the user to pull or push, thereby moving the rod 1660 relative to the body 1650 to tighten or loosen the suture 1640. The distal portion of the rod 1660 can remain within the body 1650 and be located in its corresponding longitudinal channel. The body 1660 may also include a longitudinal channel in which the suture 1640 can be received to protect the suture 1640 from being pinched or cut when tightened or loosened.

[0143] The spring assembly 1610 may also include a spring or tension release device 1675. The tension lock 1675 may include at least one of a button, a slide switch, or a pin. For example, the tension lock 1675 may include a hole in the body 1650 and a corresponding hole or recess in the rod 1660. A pin may be received in both the body hole and the rod recess to lock the body 1650 and the rod 1660 in place relative to each other. In other embodiments, a button or a slide switch may be used to lock the rod 1660 relative to the body 1650. The tension lock 1675 may be positioned such that when the tension lock 1675 is engaged, the suture is in a slack state. When the tension release device 1675 is released, the spring 1655 may pull the rod 1660 and move it proximally, thereby causing the same movement of the suture 1640 and creating tension in the suture. If the user wishes to release the suture, the proximal end of the rod 1660 may be pushed distally (toward the entry site). Once the rod 1660 is fully depressed (e.g., as shown by the position of the rod 1660 in Figure 16 ), the user may re-engage the tension lock 1675 to lock the rod 1660 in place and keep the suture 1640 slack. When the user is ready to tighten the suture 1640 again, the user may disengage the tension lock 1675 and the rod 1660 will return to its extended position (as shown in Figure 17 ).

[0144] The body 1650, the rod 1660, and the suture anchor 1635 may be made of a suitable metal or plastic material. As described above, the tensioning tube 1020 may be made of a variety of materials, such as polymers (e.g., plastics, rubbers, etc.), metals or alloys (e.g., titanium, stainless steel), or any other suitable material with sufficient stiffness to prevent deformation under the compressive loads applied by the tensioned sutures 1040A-D.

[0145] Figure 18 is a flow chart depicting an example method 1800 of using the dynamic vascular access and closure device 1600 of the present disclosure. In step 1810, an anchor and / or suture may be deployed into the vessel wall using any presently or hereafter known deployment device. Step 1810 may also include deploying a guide wire. In this step, the dynamic vascular access and closure device may tension the guide wire and / or the suture around the access site or hole in the vessel.

[0146] In step 1820, method 1800 may include inserting an intervention device through the guide wire into the vessel. In other embodiments, the suture and tensioning device may be deployed before establishing vascular access. Thus, the anchor may be placed without a guide wire and the guide wire may be inserted after the placement device. As described herein, when the intervention device is inserted, the suture may be displaced or pulled, thereby dilating the access site in the vessel.

[0147] In step 1822, method 1800 may include attaching an elastic member. For example, step 1822 may include placing a tension tube and a suture into a spring assembly (e.g., spring assembly 1610 as described above).

[0148] In step 1825, method 1800 may include tensioning the suture, e.g., by releasing the tension lock described above with respect to the dynamic vessel access and closure device 1600. The force applied to the suture by the intervention device may cause the elastic member within the tension tube to compress (or stretch in applicable embodiments). The force applied by the elastic member to the suture will bring the anchor closer to the instrument, thereby sealing the vessel wall around the instrument and preventing or reducing any unnecessary bleeding.

[0149] In step 1830, the intervention device may be withdrawn from the blood vessel. When the instrument is withdrawn, due to the decompression of the elastic member, the access hole will be automatically closed by the suture, which in turn will push the suture stopper and cause the sutures to tighten together. This automatic closure function of the access site can prevent bleeding when the intervention device is removed from the blood vessel. This automatic hemostasis technique is a significant improvement over the prior art because the user does not need to manually pinch the blood vessel to prevent bleeding. In other cases, the doctor may need to use a crossover balloon, which can be inserted from another access site and temporarily inflated to stop bleeding. The automatic tightening function provided by the embodiments of the present invention can reduce the need for such techniques. Therefore, by using the dynamic vessel access and closure device, the surgeon's operation is more convenient and the patient is safer.

[0150] As described herein, the dynamic vascular access and closure device 1600 of the present disclosure also allows for reinsertion of an interventional device through the same access site. Thus, method 1800 may include determining in step 1840 whether an additional interventional device needs to be inserted. If an additional interventional device needs to be inserted, method 1800 may include step 1845 of loosening the suture (e.g., to prevent the suture from being cut or broken during insertion of the additional device). Loosening the suture in step 1845 may include relaxing the suture by manually compressing the distal compression rod 1660 and optionally replacing or locking the tension lock. After loosening the suture, step 1820 may be repeated. If an additional interventional device does not need to be inserted, step 1850 may be performed. In step 1850, the suture lock may be locked. As described herein, the suture lock may be locked by crimping a ferrule or locking an optional lock, etc. In step 1860, the suture may be cut. The suture may be cut at any desired location, such as at the distal end of the tension tube between the tension tube and the suture lock, leaving a relatively minimal amount of excess suture connected to the patient's blood vessel. Thereafter, the tension tube assembly may be removed. In other embodiments, the suture may be cut at the proximal end of the elastic member (between the elastic member and the suture stopper), leaving a longer excess suture extending from the suture lock (which may be used to tie a knot at the end of the suture lock to provide additional security against suture unraveling).

[0151] The disclosed devices and methods can be used to close a vascular access site using a suture with a radially tightening function (described below in conjunction with Figure 19A and Figure 19B . In some examples, the suture is anchored by deploying suture anchors at two or more locations around the opening of the access site. After the suture is anchored distally, it extends through the tension tube such that the proximal end of the suture can be manipulated after leaving the proximal end of the tension tube. When the suture is tensioned, they cause the tissue around the opening of the access site to radially contract inward (as shown by the inwardly pointing arrows in Figure 19B , because the distal end of the tension tube is located near the opening, causing the suture to generate a radial force while preventing the suture from moving outward, thereby closing the opening. In some examples, the tension tube is axially rigid (while having flexible bendability) to prevent the tension tube from collapsing or kinking in a direction perpendicular to the longitudinal axis of the tube. As described above, when the tension tube is placed against (or near) the opening, it causes the suture to pull the anchored suture and tissue toward the opening (rather than pulling the tissue outward toward the proximal end of the suture), resulting in radial contraction of the opening. These radial contraction forces are represented by the horizontal arrows pointing toward each other in Figure 19B . The tension tube converts the axial force in the suture (in Figure 19BThe conversion (represented by the vertical arrow in the middle) into these radially tightening forces. Optionally, when the distal end of the structure is at or near the access site (regardless of whether a tensioning tube is used), other structures such as suture locks can also similarly assist in radially tightening the access site.

[0152] Each of the multiple sutures can be individually deployed, tensioned, advanced, and / or otherwise controlled to selectively tighten the opening located between the suture anchors. For example, when four sutures are anchored around the perimeter of the opening in an approximate square, applying similar tension to the four sutures will cause the opening to radially tighten symmetrically (i.e., generally towards the center of the opening). On the other hand, variations in the tension between the sutures may cause the opening to radially tighten asymmetrically (i.e., offset relative to the center of the opening). In various embodiments (e.g., as Figure 19A shown), the arrangement of the sutures (once deployed around the vascular opening) can be configured to achieve radial tightening by pulling the sutures (e.g., through 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 radially inwardly tighten the opening by pulling on the tissue and / or structure. Similarly, the sutures can be deployed to form approximate vertices of shapes such as a square, triangle, pentagon, hexagon, etc., with the opening located between these shapes (centrally or off-center). Additionally, the sutures can be asymmetrically deployed around the vascular access site or opening according to the size and shape of the vascular access site or opening. Other arrangements are also within the scope of the present disclosure, such as allowing linear tightening, etc.

[0153] It should be understood that terms such as "same", "equal", "planar", or "coplanar" used herein when referring to directions, layouts, positions, shapes, sizes, quantities, or other metrics do not necessarily mean exactly the same directions, layouts, positions, shapes, sizes, quantities, or other metrics, but rather refer to directions, layouts, positions, shapes, sizes, quantities, or other metrics that are nearly the same within an acceptable deviation (e.g., deviations that occur due to manufacturing processes). Unless the context or other statements clearly indicate otherwise, the term "substantially" can be used herein to emphasize this meaning. For example, items described as "substantially the same", "substantially equal", or "substantially planar" can be exactly the same, equal, or planar, or they can be the same, equal, or planar but within an acceptable deviation (e.g., deviations that occur due to manufacturing processes and / or tolerances). The term "substantially" can be used to cover this meaning, especially in cases where such deviations do not materially change the function.

[0154] It should be understood that the embodiments disclosed herein can be variously modified. Similarly, the above method can be performed in other orders. Accordingly, the above description should not be construed as limiting, but should be regarded only as examples of various embodiments. Those skilled in the art will be able to conceive of other modifications within the scope and spirit of the appended claims.

Claims

1. A dynamic vascular access and closure device for radial tightening, comprising: A tensioning tube, the tensioning tube including an elastic member disposed within the tensioning tube; A plurality of sutures, the plurality of sutures extending axially between a distal end and a proximal end of the tensioning tube, wherein a proximal end of each suture of the plurality of sutures is configured to be attached to the elastic member such that movement of the plurality of sutures causes the elastic member to be compressed or extended within the tensioning tube, and A tension lock, the tension lock having a first position and a second position; Wherein: In the first position, the tension lock is configured to hold the elastic member in a compressed state, thereby causing the sutures to be slack; and In the second position, the tension lock is configured to allow the elastic member to extend, thereby causing the sutures to be tensioned.

2. The dynamic vascular access and closure device according to claim 1, wherein, A distal end of each suture of the plurality of sutures is attached to a vascular anchor, and a proximal end of each suture of the plurality of sutures includes a suture stopper.

3. The dynamic vascular access and closure device according to claim 2, further comprising: A suture lock; And Wherein, the plurality of sutures, the vascular anchor and the suture lock comprise a body-absorbable material.

4. The dynamic vessel access and closure device according to claim 2, wherein, Each vascular anchor of the vascular anchors includes a nitinol anchor.

5. The dynamic vascular access and closure device according to claim 1, wherein, The tension lock is a trigger suture.

6. The dynamic vascular access and closure device according to claim 1, wherein, The tension lock is a frangible bridge.

7. The dynamic vessel access and closure device according to claim 1, wherein, The tensioning tube includes an elastic member stopper.

8. The dynamic vascular access and closure device according to claim 7, further comprising an applicator disposed at a proximal end of the elastic member, and wherein compression or extension of the elastic member within the tensioning tube includes compressing or extending the elastic member relative to the elastic member stopper via the applicator.

9. The dynamic vascular access and closure device according to claim 8, wherein: The tensioning tube further includes a groove; The applicator further includes a pin; In the first position, the pin engages a stopper on the tensioning tube; and In the second position, the applicator rotates such that the pin engages the groove.

10. The dynamic vascular access and closure device according to claim 7, wherein, The elastic member stopper includes a step defined by a change in the inner diameter of the tensioning tube.

11. The dynamic vascular access and closure device according to claim 1, wherein, The elastic member is configured to: Be in a first position to tighten a vascular access site between proximal ends of the plurality of sutures when proximal ends of the plurality of sutures are attached to a blood vessel; or Be in the second position when proximal ends of the plurality of sutures are pulled apart to open the vascular access site, wherein a first length of the elastic member in the first position is greater than a second length of the elastic member in the second position.

12. A dynamic vascular access and closure device, comprising: A plurality of sutures, each suture having a proximal end and a distal end, each suture of the plurality of sutures having a suture stopper at a corresponding proximal end; A tensioning tube, including: A body having a distal end and a proximal end, and A protrusion; A spring assembly, including: A body having a distal channel and a longitudinal groove, the channel being configured to receive the protrusion of the tensioning tube; A spring disposed within the body; and a rod, the rod being at least partially disposed within the body and connected to the spring; wherein each of the plurality of sutures axially extends through the body of the tensioning tube; and wherein the proximal end of each of the plurality of sutures extends through the longitudinal slot of the body and is connected to the rod.

13. The dynamic vessel access and closure device according to claim 12, wherein, The spring is a constant force spring.

14. The dynamic vessel access and closure device according to claim 12, wherein, The rod further includes a pin, and the pin is connected to the spring.

15. The dynamic vascular access and closure device according to claim 12, wherein, The longitudinal slot opens on the surface of the body such that the proximal portion of the tensioning tube and the proximal portion of each of the sutures can be placed into the body through the slot.

16. The dynamic vascular access and closure device according to claim 12, wherein, The spring assembly further includes a locking release device.

17. The dynamic vessel access and closure device according to claim 16, wherein, The tension lock includes at least one of a button, a slide switch, or a pin.

18. The dynamic vessel access and closure device according to claim 12, wherein, The proximal portion of the rod extends outside the body.

19. The dynamic vascular access and closure device according to claim 12, further comprising a suture anchor, wherein the suture anchor is configured to attach each of the plurality of sutures to the rod of the spring assembly.

20. The dynamic vascular access and closure device according to claim 19, wherein: the rod includes a recess; and the suture anchor includes a protrusion configured to be received in the recess.

21. A method of using a vascular access and closure device, comprising: deploying a plurality of sutures around a vascular access site; inserting an intervention device into the vascular access site; attaching a spring assembly to the sutures; using the spring assembly to tension the sutures; removing the intervention device from the vascular access site; automatically closing the vascular access site using the tensioned sutures; locking the sutures.

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