Vascular closure device with retraction element for repositioning sealing plug

Abstract

A vascular closure device configured to seal a perforation in an artery or vein includes a suture and a backing plate coupled to the suture. The backing plate is configured for deployment in a lumen of an artery or vein. The vascular closure device further includes a sealing plug movably coupled to the suture. The sealing plug has a front side end, a trailing side end, and a side surface extending from the front side end toward the trailing side end. The vascular closure device further includes a retraction element positioned on the sealing plug. The vascular closure device further includes a tether coupled to the retraction element. When the sealing plug is external to the deployment assembly, tension applied to the tether pulls the retraction element in the proximal direction to move the sealing plug in the proximal direction.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority under 35 U.S.C. § 119(c) to U.S. Provisional Application Serial No. 63 / 518,043, filed August 7, 2023, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present application relates to a vascular closure device having a retraction element for repositioning a sealing plug. BACKGROUND

[0004] Percutaneous access to the vascular system for delivery of vascular devices is a common medical procedure. Typically, this involves using a hollow needle to puncture a blood vessel and then introducing an introducer sheath to open the puncture site for the introduction of catheters and wire guides for navigation through the vascular system to facilitate delivery. For example, in many cases, vascular access requires the introduction of catheters and wire guides through the femoral artery. Once the procedure is complete, the device is removed from the patient and pressure is applied to the puncture site to stop bleeding. Thereafter, a closure device can be used to seal the puncture.

[0005] The closure device typically consists of three basic sealing components: a bolster (or anchor) member; a sealing member (or plug); and a filament (or suture). To lock these components together within the puncture, a locking member can be used. SUMMARY

[0006] Embodiments of the present disclosure include a vascular closure device configured to seal a puncture in an artery or vein. The vascular closure device can include a deployment assembly. The vascular closure device can further include a suture carried by the deployment assembly. The vascular closure device can further include a sealing plug movably coupled to the suture. The sealing plug can have a leading end, a trailing end, and a side extending from the leading end toward the trailing end. The sealing plug can be carried by the deployment assembly in a first configuration, and can be located outside of the deployment assembly in a second configuration. The vascular closure device can further include a retraction element positioned on the sealing plug. The vascular closure device can further include a tether coupled to the retraction element. When the sealing plug is located outside of the deployment assembly in the second configuration, tension applied to the tether can pull the retraction element in a proximal direction to move the sealing plug in the proximal direction.

[0007] Embodiments of the present disclosure include a vascular closure device configured to seal a puncture in an artery or vein. The vascular closure device can include a suture. The vascular closure device can further include a buttress coupled to the suture, wherein the buttress is configured for deployment in a lumen of the artery or vein. The vascular closure device can further include a sealing plug movably coupled to the suture, the sealing plug having a leading end, a trailing end, and a side extending from the leading end toward the trailing end. The vascular closure device can further include a retraction element positioned at the sealing plug. The vascular closure device can further include a tether coupled to the retraction element.

[0008] Embodiments of the present disclosure include a vascular closure device configured to seal a puncture in an artery or vein. The vascular closure device can include a deployment assembly having a proximal end and a distal end opposite the proximal end. The vascular closure device can further include a suture carried by the deployment assembly. The vascular closure device can further include a buttress carried by the deployment assembly and coupled to the suture. The buttress can be configured to exit the distal end of the deployment assembly for deployment in the puncture. The vascular closure device can further include a sealing plug movably coupled to the suture, the sealing plug having a leading end, a trailing end, and a side extending from the leading end toward the trailing end. The sealing plug can be carried by the deployment assembly in a first configuration, and can be located outside the deployment assembly in a second configuration. The vascular closure device can further include a retraction element positioned at the sealing plug. The vascular closure device can further include a tether coupled to the retraction element. According to such embodiments, a tension applied to the tether can pull the retraction element in a proximal direction to move the sealing plug in the proximal direction when the sealing plug is located outside the deployment assembly in the second configuration. BRIEF DESCRIPTION OF DRAWINGS

[0009] The foregoing summary, as well as the following detailed description of the examples embodiments of the present disclosure, will be better understood when read in conjunction with the accompanying drawings, in which: Figure 1 is a perspective view of a vascular closure device according to embodiments of the present disclosure; Figure 2 is Figure 1 is a partial cutaway view of the vascular closure device shown; Figure 3 is a perspective view of a vascular closure device according to embodiments of the present disclosure and with Figure 1is a front view of a sealing device associated with the vascular closure device in Figure 4 is Figure 3 is a side view of the sealing device shown in Figure 5 is Figures 3-4 is a top view of the retraction element shown in Figure 6 is Figure 5 is a side view of the retraction element shown in Figure 7 is a partial cross-sectional view of the sealing device shown in Figures 3-6 is disposed in a distal end of the vascular closure device shown in Figures 1-2 Figure 8 is a schematic perspective view of a guide member for the vascular closure device shown in Figure 1

[0010] Figure 9 is a front view of a sealing device associated with the vascular closure device in Figure 1 Figure 10 is Figure 9 is a front view of the sealing device shown in Figure 11 is Figures 9-10 is a side view of the retraction element shown in Figure 12 is Figure 11 is a top view of the retraction element shown in Figure 13 is a partial cross-sectional view of the sealing device shown in Figures 9-12 is disposed in a distal end of the vascular closure device shown in Figures 1-2 Figure 14 is a schematic view showing an access sheath being partially disposed within a blood vessel across a puncture site in the blood vessel; Figure 15 is a schematic view showing the closure device of Figure 1 being translated into an access channel of the access sheath such that a distal end of the buttress is positioned distal to a distal end of the access sheath and over the guidewire; Figure 16 is a schematic view showing the positioning of the closure device of Figure 1 relative to anatomical structures; Figure 17 is a schematic view showing the actuation of the actuator to release the buttress; ​​​​Figure 18 is a schematic view showing the deployment assembly being pulled in the proximal direction such that the buttress plate abuts the vessel wall; Figure 19 is a schematic view showing the deployment of the plug of the closure device; Figure 20 is a schematic view showing the actuation of the retraction element via the tether to reposition the sealing plug of the closure device; Figure 21 is a schematic view showing the deployment of the locking member against the plug; Figure 22 is a schematic view showing the compaction of the locking member against the plug with the compaction element; and Figure 23 is a schematic view showing the deployment of the sealing device to fully seal the puncture site. DETAILED DESCRIPTION

[0011] Certain terminology is used in the following description for convenience only and is not limiting. The words "right," "left," "lower," and "upper" designate directions in the drawings to which reference is made. The words "proximal" and "distal" refer to directions toward and away from, respectively, an individual operating the system. The terminology includes the words above specifically mentioned above, derivatives thereof and words of similar import.

[0012] Reference Figures 1-13 , an embodiment of the vascular closure device 10 can include a sealing unit 18 disposed at least partially within the deployment assembly 14 and a retraction element 50. The vascular closure device 10 can be configured such that, after the deployment assembly 14 is inserted into the vessel through a puncture site of the vessel, the sealing unit 18 is deployed to thereby seal or otherwise close the puncture site of the vessel. After deployment but before the sealing unit 18 is in its final sealing configuration, a user can retract the sealing plug 88 of the sealing unit 18 in the proximal direction with the retraction assembly 50 and even back into the deployment assembly 14. In particular, the retraction assembly 50 can allow the user to withdraw or pull back the sealing plug 88 in the event of mispositioning or misplacement of the sealing plug 88 during the medical procedure.

[0013] The deployment assembly 14 can be configured to control the orientation of the buttress plate 40 of the sealing unit 18 during use. According to the illustrated embodiment, the deployment assembly 14 can include a release component 22 (in Figure 1 and Figure 2The release member 22 can be operably coupled or associated with the suture 44 such that actuating the deployment actuator 38 causes the release member 22 to: 1) release the buttress 40, and 2) apply tension to the suture 44, which forces the buttress 40 against the delivery member 26 and orients the buttress 40 in the sealing position.

[0014] Turning to Figures 3-7 The sealing unit 18 can include the buttress 40 connected to the suture 44, a plug 88 coupled to the suture 44 and spaced apart from the buttress 40 in the proximal direction 4, and a locking member 230 on the suture 44 proximal of the plug 88.

[0015] The buttress 40 can include or define a distal end 41d and a proximal end 41p opposite the distal end 41d, a first set of holes 56 configured to receive the suture 44, a guide member hole 57, and an engagement member (engagement portion and / or engagement feature) 58. As shown, the suture 44 can extend through the first set of holes 56 such that one end of the suture 44 can form a slidable knot 232. The knot 232 can slide along the suture 44 between the plug 88 and the locking member 230. The guide member 15 can extend through the hole 57. In the implanted state, the buttress 40 can be positioned adjacent to an inner surface of a blood vessel, and the locking member 230 can press the buttress 40 and the plug 88 to an outer surface of the blood vessel to seal the perforation. The guide member 15 can extend through the sealing unit 18 and can be configured to receive a guidewire 150, as will be discussed below.

[0016] The sealing unit 18 can be formed of a material suitable for surgical procedures. For example, the buttress 40 can be made of any biocompatible material, non-limiting examples of which can include or comprise polylactic-co-glycolic acid or other synthetic absorbable polymers that degrade in the presence of water into naturally occurring metabolites. In some embodiments, the buttress can be made of stainless steel, bio-corrodible iron, and / or bio-corrodible magnesium. However, it should be appreciated that the buttress 40 can be made of other materials and can have other configurations so long as it can be disposed against a blood vessel wall inside the blood vessel.

[0017] The sealing plug 88 can include a strip of compressible, resorbable collagen foam and can be made of a fibrous collagen mixture of insoluble collagen and soluble collagen cross-linked together for strength. In the illustrated embodiment, the sealing plug 88 has a leading end 89, a trailing end 90, and a side face 91 extending from the leading end 89 toward the trailing end 90. It will be appreciated, however, that the sealing plug 88 can have any configuration as desired and can be made of any material as desired. The suture 44 can be any elongate member such as, for example, a filament, a thread, a wire, or a braid. The sealing plug 88 can be movably coupled to the suture 44.

[0018] The deployment assembly 14, including the release component 22 and the delivery component 26, can be constructed and function according to one or more devices disclosed in U.S. Patent No. 11,364,024, the entirety of which is incorporated by reference into the present application. Referring again to Figure 1 、 Figure 2 and Figure 7 , the deployment assembly 14 can be elongate along a longitudinal direction L and can include a proximal end 16p and a distal end 16d spaced apart from the proximal end 16p along an axis 6, which can be aligned with the longitudinal direction L. The longitudinal direction L can include and define a distal direction 2 extending from the proximal end 16p toward the distal end 16d. Further, the longitudinal direction L can include and define a proximal direction 4 opposite the distal direction 2 and extending from the distal end 16d toward the proximal end 16p. The deployment assembly 14 can be configured to insert the buttress 40 into the blood vessel along an insertion direction I (see Figure 7 ). During a portion of the sealing procedure, the longitudinal direction L can be aligned with the insertion direction I.

[0019] Turning to Figure 1 and Figure 2 , according to the illustrated embodiment, the deployment assembly 14 can include the handle member 20, the release component 22 supported by the handle member 20, the delivery component 26, the tensioner 28 supported by the handle member 20, and at least one deployment actuator 38. A portion of the release component 22 is shown in dashed lines in Figure 1 and Figure 2 .

[0020] Deployment actuator 38 may be coupled to both handle member 20 and release member 22. Deployment actuator 38 may be configured to 1) move release member 22 in the proximal direction 4 from a first position or initial position relative to delivery member 26 to a second position or release position relative to delivery member 26, and 2) apply tension to suture 44 during or after the movement of release member 22 from the initial position to the release position. The following description relates to the ability of release member 22 to move relative to delivery member 26, but in some examples, deployment assembly 14 may be configured to enable delivery member 26 to move relative to release member 22. Deployment assembly 14 may also include guide member 15 and optional outer sheath 23 (see [link to documentation]). Figure 7 The guide member 15 extends through the deployment assembly 14, and the outer sheath 23 includes and supports portions of the release member 22 and the delivery member 26.

[0021] continue Figure 1 and Figure 2 The handle component 20 may include a housing 21a, a sheath 21b, and a cavity 21c, which is at least partially defined by the housing 21a and the sheath 21b. The cavity 21c may be sized to include a portion of the release component 22 and the delivery component 26, as well as the tensioner 28. The sheath 21b may be configured to mate with the access sheath 208 (see [link to relevant documentation]). Figure 6 and Figure 14 ).

[0022] Release member 22 may be elongated along a first direction or longitudinal direction L and may define a distal end and a proximal end, the proximal end being spaced apart from the distal end along the longitudinal direction L. Release member 22 may include a release tube body extending along the longitudinal direction L. The release tube body may define a release tube channel extending along the longitudinal direction L from the housing toward the proximal end. The size of the release tube channel may be configured to slidably receive a portion of delivery member 26, such that release member 22 is movable relative to delivery member 26. Non-limiting examples of these features and one or more of their components, including additional features of release member 22, are described in U.S. Patent No. 11,364,024.

[0023] Tensioner 28 can be positioned within handle member 20 and coupled to the proximal end of release member 22. In one example, suture 44 can extend around a pulley and into tensioner 28. When release member 22 is pulled in the proximal direction 4, the pulley can pull suture 44 in the proximal direction 4, thereby applying tension to pad 40. Other arrangements can be used to apply tension to suture 44 and pad 40 as needed.

[0024] Delivery member 26 may be coupled to tensioner 28 and may extend along release member 22 toward the distal end 16d of deployment assembly 14. Delivery member 26 may include delivery tube body extending along a first direction L and defining a distal end and a proximal end spaced apart from the distal end in the first direction L. Delivery tube body may define delivery tube channel extending at least partially through delivery tube body along the first direction L. As shown, the proximal end of delivery member may be secured to tensioner 28, and the distal end of delivery member may be configured to retain at least a portion of sealing unit 18 (see Figure 1). Figure 7 Non-limiting examples of these features and one or more of their components are described in U.S. Patent No. 11,364,024, including additional features of the release component 26.

[0025] The delivery tube channel can be sized to retain at least a portion of the sealing unit 18. Specifically, the plug 88 and locking member 230 can be retained within the delivery tube channel, while the pad 40 can be configured to be initially trapped between the delivery member 26 and the release member 22. For example, the distal end of the release tube can define an offset surface 49, such as... Figure 7 As shown, the offset surface can be angled relative to the longitudinal axis 6. The offset surface 49 and the inner surface of the delivery member 26 can define a cavity when the release member 22 is in this initial position (e.g., Figure 7 As shown, the cavity receives the proximal end 41p of the receiving pad 40. The angle of the offset surface 49 can define the orientation of the pad 40 in this initial position, whereby the distal end 41d of the pad 40 can be spaced apart in the distal direction 2 by a distance exceeding the distal ends of the release member 22 and the delivery member 26, respectively. The suture 44 can extend from the pad 40 through the delivery tube channel, passing through the proximal end of the pulley surrounding the tensioner 28. The guide member 15 can extend through the delivery member and exit from the distal end 16d of the vascular closure device 10.

[0026] When the deployment actuator 38 is actuated, the release member 22 can move in the proximal direction 4, thereby releasing the proximal end 41p of the pad 40 from between the release member 22 and the delivery member 26. As the release member 22 moves in the proximal direction 4, the suture 44 can be pulled in the proximal direction 4, thereby placing the suture 44 in a taut state and forcing the pad 40 against the distal end of the delivery member 26. At this time, the pad 40 can be oriented in a sealed position. In the sealed position, the pad 40 has been repositioned such that, compared to its position when constrained by the release member 22, the pad 40 is positioned against the distal end of the delivery member 26 and is oriented more laterally relative to the axis 6.

[0027] Deployment component 14 may include one or more actuators configured to turn release member 22 to a release position and apply tension to suture 44 when pad 40 is released from release member 22, as described above. Deployment actuator 38 may engage release member 22 such that movement of deployment actuator 38 relative to handle member 20 causes the release member to translate in the proximal direction 4 and further apply tension to suture 44. As a result, rotation or movement of deployment actuator 38 may cause release member 22 to translate in the longitudinal direction L. As shown, deployment actuator 38 may be configured as a lever rotatably coupled to handle member 20. However, deployment actuator 38 may be a knob or slider. It should be understood, however, that deployment actuator 38 may have other configurations as needed and is not limited to the disclosed lever.

[0028] refer to Figures 3-7 This describes a sealing assembly or sealing unit 18 having a retractable element 50 according to embodiments of the present disclosure. The retractable element 50 can be configured to retract, for example, in response to manual engagement by a user, the sealing plug 88 in a proximal direction. The retractable element 50 may include a retractable body 51 having a front surface 51a and a rear surface 51b opposite to the front surface, wherein the rear surface 51b is opposite to the front end 89 of the sealing plug 88. Figure 5 and Figures 3-7 As shown, the retractable body 51 may have a plurality of holes 53 configured to allow blood or fluid to pass through the retractable element 50. The retractable element 50 may be positioned at the front end 89 of the sealing plug 88, wherein the retractable body may serve as a support.

[0029] The retraction element 50 (or retraction assembly) may include a tether 52 attached to the retraction body 51. The tether 52 may be any elongated element attached to the retraction body 51. Thus, the tether 52 may be an elongation shaft, suture thread, filament, silk thread, or rod. Figure 6 In the illustrated embodiment, the tether 52 extends through the deployment assembly 14. However, in an alternative configuration, the tether 52 may extend along the deployment assembly 14. When the sealing plug 88 is in a configuration located outside the deployment assembly 14, the tension applied to the tether 52 can pull the retraction element 50 in a proximal direction to move the sealing plug 88 in that proximal direction. In some examples, the retraction element 50 may include or define a tether attachment point or tether attachment portion 73, such as... Figure 7 As shown. Additionally or alternatively, the tether 52 may be wound around the retracted body 51 to form a loop or lasso, as... Figure 8 As shown.

[0030] The retraction element 50 may be porous, allowing blood and other fluids to pass through without degradation or decomposition. Therefore, the retraction element 50 may be configured as a mesh structure. The retraction element 50 may also be substantially bioabsorbable. The retraction assembly may also include a retraction actuator 47 configured to pull the tether 52 in a proximal direction to at least retract the sealing plug 88 in the proximal direction opposite to the distal direction. In one example, the actuator may include a push-pull member, which may include a rod and a thread. In another example, the actuator may be a rotatable knob, a rotatable lever, or a slider. In alternative embodiments, the sealing unit 18 may include more than one retraction element, such as a first retraction element and a second retraction element.

[0031] like Figures 14-18 As shown, the guide member 15 may have an elongated body 60 having a proximal end 62, a distal end 64, and a lumen 66 extending from the proximal end 62 to the distal end 64. The lumen 66 may be configured to receive a guidewire, such as guidewire 150 (see Figure 150), passing through it. Figure 17 The guide member 15 may also include a pad engagement member 68 configured to abut the pad 40. The guide member 15 may also include a push engagement member 70 configured to push the guide member 15 in a distal direction when a force is applied to the push engagement member 70. The guide member 15 may include an actuator 76, which may be configured as a gripping member as shown, and in some examples, this gripping member may be manually engaged by a user.

[0032] In operation, the deployment assembly 14 can initially be configured to insert the pad 40 into a blood vessel. When the deployment actuator 38 is actuated, the release member 22 can move in the proximal direction 4 relative to the delivery member 26 to a release position, thereby releasing the proximal end 41p of the pad 40 from between the release member 22 and the delivery member 26. As the release member 22 moves in the proximal direction 4, the suture 44 can be pulled in the proximal direction 4, thereby placing the suture 44 in a taut state and forcing the pad 40 against the distal end of the delivery member 26. At this time, the pad 40 can be oriented in a sealed position (e.g., see...). Figures 9-13 Therefore, the release member 22 can be configured to constrain the pad 40 of the sealing unit 18 during the insertion of the vascular closure device 10 into the blood vessel, and then release the pad 40 so that the pad 40 can be oriented for the sealing procedure.

[0033] refer to Figure 9This paper describes a sealing unit 18 with a retractable element according to another embodiment of the present disclosure. As shown, the retractable element 54 can be configured to retract the sealing plug 88 in a proximal direction. The retractable element 54 may include a first portion 55 positioned at a front end 89 of the sealing plug 88 and a second portion 59 adjacent to a side surface 91 of the sealing plug 88. The retractable element 54 may further include a distal wall 61 and a side wall 63 extending in a proximal direction relative to the distal end, wherein the distal wall 61 and the side wall 63 define an interior space 65 that includes or receives the front end of the sealing plug 88. The distal wall 61 and the side wall 63 include a plurality of orifices 67 configured to allow blood or fluid to flow through the retractable element, which can be positioned at the front end 89 of the sealing plug 88. Figure 10 The arrangement of the sealing unit 18 with the sealing plug 88 in an uncompressed state is depicted, and Figure 9 Another configuration is depicted in which the sealing unit 18 is located and the sealing plug 88 is in a compressed state. For ease of reference, Figure 10 and Figure 3 Zhongyu Figure 4 and Figure 11 Components that are similar or identical to those shown in the figures are assigned the same reference numerals. Figure 12 A side view of the retracted element 54 is provided, and Figure 13 A top view of the retracted element 54 is provided. Figure 1 This illustrates positioning in a vascular closure device (such as...) Figure 2 and Figures 3-7 The retractable element 54 is located in the distal portion of the vascular closure device 10 and the proximal portion of the bypass tube (BT).

[0034] The retraction element 54 may include or be connected to a tether 69. The tether 69 may be any elongated element connected to the retraction element 54. Therefore, the tether 69 may be an elongated shaft, suture, filament, thread, or rod. In the illustrated embodiment, the tether 69 extends through the deployment assembly 14. However, in an alternative configuration, the tether 69 may extend along the deployment assembly 14. When the sealing plug 88 is configured to be outside the deployment assembly 14, the tension applied to the tether 69 may pull the retraction element 54 in a proximal direction to move the sealing plug 88 in that proximal direction.

[0035] The retraction element 54 may be porous, allowing blood and other fluids to pass through without degradation or decomposition. Consequently, the retraction element 54 may be configured as a cup- or lid-shaped mesh structure, configured to surround, slide onto, and / or wrap around the distal end of the sealing plug 88. The retraction element 54 may also be substantially bioabsorbable. The retraction assembly may also include a retraction actuator (e.g., actuator 47) configured to pull the tether 69 in a proximal direction to at least retract the sealing plug 88 in the proximal direction opposite to the distal direction. In one example, the actuator may include a push-pull member, which may include a rod and a thread. In another example, the actuator may be a rotatable knob, a rotatable lever, or a slider. In some embodiments, the sealing unit 18 may include a first retraction element and a second retraction element.

[0036] Embodiments of this disclosure will now be described with respect to an exemplary large-aperture surgery, which utilizes, as Figures 9-13 The disclosed vascular closure device 10 and sealing unit 18 having retractable element 50. However, it should be noted that, as Figures 14-23 The sealing unit 18 with retractable element 54 disclosed herein can also be used in large-aperture surgeries, examples of which are described herein.

[0037] To perform any related procedure, the user obtains a percutaneous access to, for example, the femoral artery, resulting in a puncture site within the artery. To obtain a percutaneous access to the artery, the Seldinger technique can be used. For example, a hollow needle can be inserted into the artery. A guidewire 150 can then be advanced through the hollow needle and into the femoral artery a sufficient distance to allow the needle to be removed without the guidewire 150 being pulled out of the vessel. Removing the needle leaves the guidewire 150 in place, with a portion of the guidewire 150 extending into the artery. The guidewire 150, extending from outside the patient into the femoral artery, provides access guidance for other medical devices, including the vascular closure device 10. Thus, once the guidewire 150 is positioned in the patient's vessel, a catheter or guide with a gradually increasing diameter can advance over the guidewire and through the perforation into the artery to further open the puncture site. The guide / surgical access sheath assembly (i.e., the guide inside the access tube or sheath) can then be moved along the guidewire 150, allowing the distal end of the sheath to move through the puncture site into the blood vessel. Once positioned, the guide can be removed, allowing the sheath to provide a fairly large access route from outside the body to inside the blood vessel.

[0038] After the relevant surgery is completed, the puncture site created by the percutaneous needle during the percutaneous approach to the artery can be closed. The vascular closure device 10 can be used to seal the puncture site. Figure 14 A schematic diagram of the vascular closure device 10 is shown during the process of closing the puncture site 200 in the wall 204 of a blood vessel (e.g., an artery).

[0039] Now for reference Figure 14 To deliver the vascular closure device 10 to the puncture site 200 so that the closure device 10 can seal the puncture site 200, a closure access sheath 208 can be used to replace the guide / surgical sheath assembly. For example, as... Figure 14 As shown, the surgical sheath can be replaced with a closed access sheath 208 by removing the surgical sheath from the patient, leaving the guidewire 150 in place, and then moving or otherwise positioning the closed access sheath 208 along the guidewire 150, such that a portion of the access sheath 208 is placed within the blood vessel through the puncture site 200. Figure 15 As shown, the ingress sheath 208 defines the distal end D. A Proximal P A and access channel 212, which is along the insertion direction I from the proximal end P A Extending to the distal end D A The access sleeve 208 may be further included at its proximal end P. A The sheath 216 is located at the insertion point. The sheath 216 can be configured to be coupled to the vascular closure device 10 when the vascular closure device 10 is inserted into the access channel 212 along the insertion direction I.

[0040] like Figures 16-18 As shown, the vascular closure device 10 can be positioned by translating, extending, or otherwise advancing the vascular closure device 10 into and through the access channel 212 along the insertion direction I, such that a portion of the pad 40 (e.g., the distal portion 41d) extends from the distal end D of the access sheath 208. A The device protrudes and enters the blood vessel. Once fully inserted, the vascular closure device 10 can be attached to the sheath housing 216. As the vascular closure device 10 moves through the puncture site 200 into the blood vessel, the proximal end of the pad 40 can be attached to the release component 22 and the delivery component 26. When the proximal end of the pad 40 is secured, the pad 40 can be oriented in a pre-sealed position, whereby at least the proximal end of the pad 40 is concealed, and thus prevented from dragging against the vessel wall while the pad 40 is positioned within the blood vessel.

[0041] Once the vascular closure device 10 is correctly positioned within the access sheath 208, the pad 40, and particularly the entire combination of the access sheath 208 and the vascular closure device 10, can be moved proximally, positioning the pad 40 adjacent to the puncture site 200. Figure 17 As shown. In some cases, the pad 40 may not be in the proper position for sealing. In this case, the user can use various visualization techniques or tools (such as a puncture locator, radiography, or other means) to determine the position of the pad 40 to identify its location. The user can then retract the pad 40 in a proximal direction toward the distal end of the deployment assembly 14 and withdraw it from the lumen of the artery or vein. A non-limiting embodiment of the retraction of the pad 40 is disclosed in U.S. Provisional Patent Application No. 63 / 517,979, filed August 7, 2023, entitled “VASCULAR CLOSURE DEVICE WITH RETRACTION ASSEMBLY FORREPOSITIONING A FOOTPLATE,” the entire contents of which are incorporated herein by reference.

[0042] like Figure 18 As shown, once the pad 40 is in place, the deployment actuator 38 is actuated (by moving in the direction of the curved arrow) to release the pad 40 from the release tube and then apply tension to the suture 44 to pull the pad 40 against the distal end of the delivery member 26.

[0043] At the pad 40 Figure 19 In the sealed position shown, the deployment assembly 14, together with the access sheath 208, can be pulled proximally so that the pad 40 abuts against the vessel wall 204. Figures 19-20 As shown, further pulling of the device 14 and the sheath 208 can completely withdraw the sealing unit 18 (including the pad 40, plug 88, locking member 230, suture 44, and compactor 234) from the delivery member 26. By pulling the suture 44 in a direction away from the blood vessel (i.e., in the opposite direction to the insertion direction I), the suture 44 can be tensioned, and the pad 40 can be moved completely to a position abutting against the inner surface of the blood vessel wall 204 at the puncture site 200. The tension in the suture 44 can also pull the plug 88 into the puncture site 200, such that the plug 88 substantially fills the puncture site 200.

[0044] As mentioned above, in some cases, the sealing plug 88 may not be in the proper position for sealing after its insertion. In such cases, the user can use various visualization techniques to determine the position of the plug 88, non-limiting examples of which are also pointed out above. Figures 20-21As shown in the progress diagram, the user can retract the sealing plug 88 proximally toward the distal end of the deployment assembly 14 and from the lumen of the artery or vein. In this case, retraction of the plug 88 proximally can be achieved at least partially by retracting the tether 52 attached to the retraction element 50, which is positioned on the sealing plug 88, for example, at its distal end or surface. The sealing plug 88 can be retracted toward or into the delivery assembly 10 (e.g., delivery member 26). After retracting the plug 88 proximally using the tether 52 and the retraction element 50, the user can advance the plug 88 distally toward the lumen of the artery or vein back to the correct position, such as from... Figure 21 As shown in the progress. After the plug 88 is positioned and comes into contact with blood or other fluid within the puncture site 200, the plug 88 can expand and fill the remainder of the puncture site 200.

[0045] After the user has pulled the suture 44 to create tension within it and allow the plug 88 to enter the puncture site 200, the user can advance the compactor 234 distally along the guide wire 150 and the suture 44. Figure 22 As shown, the compactor 234 can contact the locking member 230 and advance the locking member 230 distally along the suture 44 until the locking member 230 contacts the plug 88 and presses the plug 88 against the outer surface of the blood vessel. When the plug 88 is compressed by the compactor 234, the plug 88 can fold over and within the puncture site 200. However, it should be understood that in some embodiments, the delivery member 26 can be pulled so that the plug 88 is removed from the delivery member 26 within the release member 22, and the compactor 234 is deployed within the release member 22. In such embodiments, the release member 22 can help control the plug 88 as it is compacted against the puncture site.

[0046] like Figure 23 and Figure 22 As shown, the locking member 230, together with the plug 88 and the pad 40, can achieve a seal at the puncture site 200. Tension can be maintained on the suture 44 throughout the deployment of the plug 88 from the delivery member 26. After sealing the puncture site 200, the guide wire 150 can be removed, as... Figure 23 As shown. When the guidewire 150 is removed, the suture 44 can remain taut, and the user can, if necessary, re-compress the plug 88 using the compactor 234 to confirm proper sealing of the puncture site 200. Once properly sealed, the suture 44 can be cut so that the remaining suture 44, the compactor 234, and other components of the sealing unit 18 can be removed from the puncture site 200, as shown. ​As shown. The remaining portion of the sealing unit 18 (including the pad 40, the plug 88, a portion of the suture 44, and the locking member 230 (depending on the material used)) can be reabsorbed into the patient over time.

[0047] While the foregoing description and accompanying drawings illustrate preferred embodiments of the invention, it should be understood that various additions, modifications, combinations, and / or substitutions may be made therein without departing from the spirit and scope of the disclosure as defined in the appended claims. In particular, those skilled in the art will appreciate that the disclosure may be embodied in other specific forms, structures, arrangements, proportions, and other elements, materials, and components without departing from the spirit or essential characteristics of the disclosure. Those skilled in the art will understand that the disclosure can be used with numerous modifications to structure, arrangement, proportion, materials, and components that are particularly suited to specific environments and operational requirements without departing from the principles of the disclosure. Furthermore, the features described herein may be used alone or in combination with other features. For example, a feature described in connection with one component may be used and / or interchanged with a feature described in another component. Therefore, the embodiments disclosed herein are to be considered illustrative rather than restrictive in all respects, and the scope of the disclosure is indicated by the appended claims and is not limited to the foregoing description.

[0048] Those skilled in the art will understand that various modifications and alterations can be made to this disclosure without departing from the broad scope of the appended claims. Some of these have been discussed above, and others will be apparent to those skilled in the art. The following examples provide non-limiting embodiments of various configurations of the apparatuses, components, systems, and methods disclosed herein.

[0049] In Example 1, a vascular closure device is configured to seal a perforation in an artery or vein. The vascular closure device may include a deployment assembly, a suture carried by the deployment assembly, and a sealing plug movably coupled to the suture. The sealing plug may have a front end, a rear end, and a side extending from the front end toward the rear end. The sealing plug may be carried by the deployment assembly in a first configuration and may be located outside the deployment assembly in a second configuration. The closure device may also include a retraction element positioned on or at the front end of the sealing plug. The closure device may also include a tether coupled to the retraction element. When the sealing plug is in the second configuration located outside the deployment assembly, tension may be applied to the tether, which may pull the retraction element in the proximal direction to move the sealing plug in the proximal direction.

[0050] In Example 2, a vascular closure device is configured to seal a perforation in an artery or vein. The vascular closure device may include a suture, a pad attached to the suture, a sealing plug movably attached to the suture, a retractable element positioned at the sealing plug, and a tether attached to the retractable element. The pad may be configured for deployment within the lumen of the artery or vein. The sealing plug may have a front end, a rear end, and a side extending from the front end toward the rear end.

[0051] In Example 3, a vascular closure device is configured to seal a perforation in an artery or vein. The vascular closure device may include a deployment assembly having a proximal end and a distal end opposite to the proximal end. The closure device may also include a suture carried by the deployment assembly and a pad carried by the deployment assembly and attached to the suture. The pad may be configured to be positioned distal to the deployment assembly for deployment in the perforation. The closure device may also include a sealing plug movably attached to the suture. The sealing plug may have a front end, a rear end, and a side extending from the front end toward the rear end. The sealing plug may be carried by the deployment assembly in a first configuration and may be positioned outside the deployment assembly in a second configuration. The closure device may also include a retraction element positioned at the sealing plug and a tether attached to the retraction element. When the sealed plug is in the second configuration outside the deployment assembly, tension applied to the tether may pull the retraction element in a proximal direction to move the sealing plug in that proximal direction.

[0052] In Example 4, the closure device according to any one or any combination of Examples 1 to 3 can be configured such that the retractable element is porous, allowing blood and other fluids to pass through it.

[0053] In Example 5, the closure device according to any one or any combination of Examples 1 to 4 can be configured such that the retractable element includes a retractable body having a front surface and a rear surface opposite to the front surface, wherein the rear surface is opposite to the front end of the sealing plug.

[0054] In Example 6, the closure device according to any one or any combination of Examples 1 to 5 can be configured such that the retractable body has a plurality of holes configured to allow blood or fluid to pass through the retractable element.

[0055] In Example 7, the closure device according to any one or any combination of Examples 1 to 6 can be configured such that the retractable element is substantially bioabsorbable.

[0056] In Example 8, the closing device according to any one or any combination of Examples 1 to 7 can be configured such that the retractable element is a mesh structure.

[0057] In Example 9, the closing device according to any one or any combination of Examples 1 to 4 can be configured such that the retractable element has a first portion positioned at the front end of the sealing plug and a second portion adjacent to the side of the sealing plug.

[0058] In Example 10, the closure device according to any one or any combination of Examples 1 to 4 can be configured such that the retractable element has a distal wall and a sidewall extending in the proximal direction relative to the distal end, wherein the distal wall and the sidewall define an internal space that includes the front end of the sealing plug.

[0059] In Example 11, the closing device according to Example 10 can be configured such that the distal sidewall and the sidewall include a plurality of holes.

[0060] In Example 12, the closure device according to any one or any combination of Examples 9 to 11 can be configured such that the retractable element is substantially bioabsorbable.

[0061] In Example 13, the closing device according to any one or any combination of Examples 9 to 12 can be configured such that the retractable element is a mesh structure.

[0062] In Example 14, the closing device according to any one or any combination of Examples 1 to 13 can be configured such that the retractable element is a first retractable element and further includes a second retractable element.

[0063] In Example 15, the closure device according to any one or any combination of Examples 1 to 14 can be configured such that the tether is a stitching thread.

[0064] In Example 16, the closure device according to any one or any combination of Examples 1 to 14 can be configured such that the tether is a filament.

[0065] In Example 17, the closure device according to any one or any combination of Examples 1 to 14 can be configured such that the tether is a silk thread.

[0066] In Example 18, the closure device according to any one or any combination of Examples 1 to 14 can be configured such that the tether is an extension shaft.

[0067] In Example 19, the closing device according to any one or any combination of Examples 1 to 18 can be configured such that the tether extends through the deployment component.

[0068] In Example 20, the closing device according to any one or any combination of Examples 1 to 18 can be configured such that the tether extends along the deployment component.

[0069] In Example 21, the closure device according to any one or any combination of Examples 1 to 20 can be configured such that it further includes a movable lock along the suture line and a compactor that can slide along the suture line, wherein the compactor is configured to allow the movable lock to slide into engagement with the sealing plug.

[0070] In Example 22, the closing device according to any one or any combination of Examples 1-21 can be configured such that the deployment component further includes a release member and a delivery member, wherein either or both of the release member and the delivery member are movable relative to the other to release the pad.

[0071] In Example 23, the closure device according to Example 1 can be configured to further include a pad attached to a suture, wherein the pad is configured for deployment in the lumen of the artery or vein.

[0072] In Example 24, the closing device according to any one or any combination of Examples 1 to 3 can be configured such that the retractable element is positioned at the front end of the sealing plug.

[0073] In Example 25, a method for sealing a perforation in an artery or vein involves positioning a deployment assembly at the distal end of the perforation relative to the artery or vein, advancing a plug of the sealing unit toward the perforation of the artery or vein along a suture to the outside of the distal end of the deployment assembly, wherein the plug is movably coupled to the suture, and retracting the plug in a proximal direction.

[0074] In Example 26, the method according to Example 25 can be implemented such that the plug of the sealing unit is advanced toward the perforation of the artery or vein to the outside of the distal end of the deployment assembly, further involving pulling the deployment assembly in the proximal direction to induce tension along the suture, thereby causing the plug to leave the distal end of the deployment assembly, and compacting the plug toward the perforation using a compactor capable of sliding along the suture.

[0075] In Example 27, the method according to one or both of Examples 25 or 26 may further involve retracting the plug inside the distal end of the deployment component.

[0076] In Example 28, the method according to one or any combination of Examples 25 to 27 may further involve, after retracting the plug into the distal end of the deployment assembly, disengaging the plug from the distal end of the deployment assembly and inserting it into the perforation of the artery or vein.

[0077] In Example 29, the method according to Example 25 may further involve advancing a pad of the sealing unit away from the distal end of the deployment assembly and into the lumen of the artery or vein, and retracting the pad toward the distal end of the deployment assembly.

[0078] In Example 30, the method according to Example 29 may further involve determining the position of the sealing unit relative to the lumen of the artery or vein.

[0079] In Example 31, the method according to Example 29 may further involve retracting the pad into the distal end of the deployment component.

[0080] In Example 32, the method according to Example 29 may further involve, after retracting the pad toward the distal end of the deployment assembly, moving the pad away from the distal end of the deployment assembly and into the lumen of the artery or vein.

[0081] In Example 33, the method according to any one or any combination of Examples 25 to 32 may further involve inserting an access sheath into a perforation of the artery or vein, the access sheath having a proximal end positioned outside the artery or vein, a distal end located in the lumen of the artery or vein, and a channel extending from the distal end of the access sheath to the proximal end.

[0082] In Example 34, the method according to any one or any combination of Examples 25 to 33 can be implemented such that inserting the distal end of the deployment component into the perforation of the artery or vein further involves inserting the deployment component into the channel of the access sheath until the distal end of the deployment component extends out of the distal end of the access sheath.

[0083] In Example 35, the method according to any one or any combination of Examples 25 to 34 can be implemented such that the pad is restricted by the release and delivery parts of the deployment assembly, wherein moving the pad away from the distal end of the deployment assembly further includes moving either or both of the release and delivery parts relative to each other to release the pad from the deployment assembly.

[0084] In Example 36, the method according to Example 25 may further involve retracting the plug toward the distal end of the deployment component.

[0085] In Example 37, the method according to any one or any combination of Examples 25 to 36 can be implemented using any one or any combination of the vascular closure device or its components from Examples 1 to 24.

Claims

1. A vascular closure device configured to seal a puncture in an artery or vein, the vascular closure device comprising: a suture; a buttress coupled to the suture, wherein the buttress is configured for deployment in a lumen of the artery or vein; a sealing plug movably coupled to the suture, the sealing plug having a leading end, a trailing end, and a side extending from the leading end toward the trailing end; a retraction element positioned at the sealing plug; and a tether coupled to the retraction element. The retraction element is porous such that blood and other fluids are able to pass therethrough.

2. The vascular closure device according to claim 1, wherein, The retraction element includes a retraction body having a front surface and a back surface opposite the front surface, wherein the back surface is opposite the leading end of the sealing plug.

3. The vascular closure device according to claim 1, wherein, The retraction retraction body has a plurality of pores configured to allow blood or fluid to pass through the retraction element.

4. The vascular closure device according to claim 3, wherein, The retraction element is substantially bioabsorbable.

5. The vascular closure device according to claim 1, wherein, The retraction element includes a mesh structure.

6. The vascular closure device according to claim 1, wherein, The retraction element has a first portion positioned at the leading end of the sealing plug and a second portion adjacent the side of the sealing plug.

7. The vascular closure device according to claim 1, wherein, The retraction element has a distal wall and a side wall extending in a proximal direction relative to the distal end, wherein the distal wall and the side wall define an interior space including the leading end of the sealing plug.

8. The vascular closure device according to claim 7, wherein, The distal wall and the side wall of the retraction element include a plurality of pores.

9. The vascular closure device according to claim 8, wherein, The retraction element is substantially bioabsorbable.

10. The vascular closure device according to claim 9, wherein, The retraction element includes a mesh structure.

11. The vascular closure device according to claim 9, wherein, The retraction element is a first retraction element and further includes a second retraction element.

12. The vascular closure device according to claim 1, wherein, The tether includes a suture.

13. The vascular closure device according to claim 1, wherein, The tether is a filament.

14. The vascular closure device according to claim 13, wherein, The tether includes a wire.

15. The vascular closure device according to claim 1, wherein, The tether includes an elongated shaft.

16. The vascular closure device according to claim 1, wherein, The tether extends through the deployment assembly.

17. The vascular closure device according to claim 1, wherein, The tether extends along the deployment assembly.

18. The vascular closure device according to claim 1, wherein, 19. The vascular closure device of claim 1, further comprising a movable lock positioned along the suture and a compaction element slidable along the suture, the compaction element configured to slide the movable lock into engagement with the sealing plug.

20. The vascular closure device of claim 1, further comprising a buttress coupled to the suture, wherein the buttress is configured for deployment in a lumen of the artery or vein. ​

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