Vascular closure device with retraction assembly for repositioning backing plate

Abstract

A vascular closure device is configured to seal a perforation in an artery or vein. The vascular closure device includes a deployment assembly having a proximal end and a distal end opposite the proximal end, a suture carried by the deployment assembly, and a backing plate carried by the deployment assembly and coupled to the suture. The backing plate is configured to exit the distal end of the deployment assembly for deployment in the aperture. The vascular closure device includes a retraction assembly coupled to a backing plate, the retraction assembly configured to retract the backing plate in a proximal direction after deployment of the backing plate.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 517,979, filed August 7, 2023, pursuant to 35 U.SC §119(c), the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to a vascular closure device having a retraction component for repositioning a pad. Background Technology

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

[0005] This closure device typically consists of three basic sealing components: a gasket (or anchor) member; a sealing member (or plug); and a filament (or suture). Locking members can be used to secure these components together within the perforation. Summary of the Invention

[0006] Embodiments of this disclosure include a vascular closure device configured to seal a perforation in an artery or vein. Examples of the vascular closure device may include a deployment assembly having a proximal end and a distal end opposite to the proximal end, a suture carried by the deployment assembly, and a pad carried by the deployment assembly and coupled to the suture. The pad may be configured to be located away from the distal end of the deployment assembly for deployment in the perforation. The vascular closure device may include a retraction assembly coupled to the pad, the retraction assembly being configured to retract the pad in a proximal direction after deployment.

[0007] In some embodiments, the vascular closure device may include a deployment assembly having a proximal end and a distal end opposite to the proximal end, a suture carried by the deployment assembly, and a pad carried by the deployment assembly and coupled to the suture. The pad may be configured to be disengaged from the deployment assembly for deployment in the perforation. The vascular closure device may include a tether coupled to the pad. The tether may be configured to retract the pad in a proximal direction, for example, in response to manual engagement by a user, after the pad has been disengaged from the deployment assembly.

[0008] In some embodiments, the vascular closure device may include a deployment assembly having a proximal end and a distal end opposite to the proximal end, a suture carried by the deployment assembly, and a pad carried by the deployment assembly and coupled to the suture. The pad may be configured to 1) exit the deployment assembly for deployment, and 2) retract in a proximal direction after deployment. The vascular closure device may further include a guide member having an elongated body and a pad engaging member configured to abut the pad. After deployment of the pad, the abutment of the pad engaging member against the abutment of the pad may cause the pad to pivot to retract in the proximal direction.

[0009] Embodiments of this disclosure include methods for sealing perforations in arteries or veins. Examples of the method may involve inserting the distal end of a disclosed deployment assembly into the perforation of the artery or vein. The method may also involve disengaging a gasket of a sealing unit from the distal end of the deployment assembly and into the lumen of the artery or vein. The method may further involve determining the position of the gasket within the lumen of the artery or vein. The method may also involve retracting the gasket proximally toward the distal end of the deployment assembly and disengaging the gasket from the lumen of the artery or vein. Attached Figure Description

[0010] The foregoing summary and the following detailed description of exemplary embodiments of this disclosure will be better understood when read in conjunction with the accompanying drawings, in which exemplary embodiments are shown for illustrative purposes. However, it should be understood that this application is not limited to the precise arrangements and systems shown in the drawings, wherein: Figure 1 This is a perspective view of a blood vessel closure device according to an embodiment of the present disclosure; Figure 2 yes Figure 1 A partial cross-sectional view of the vascular closure device shown; Figure 3 Is with Figure 1 A perspective view of the sealing device associated with the illustrated vascular closure device; Figure 4 It is shown Figure 3 A partial cross-sectional view of the sealing device shown, wherein the sealing device is arranged... Figure 1 In the distal end of the vascular closure device shown; Figure 5 It is used for Figure 1 A perspective view of the guide member and gripping part of the vascular closure device shown; Figure 6 This is a schematic diagram showing an access sheath that partially positions the puncture site within a blood vessel. Figure 7 This shows the access channel that is translated into the access sheath. Figure 1 A schematic diagram of the closure device, in which the distal end of the pad is positioned distal to the distal end of the inlet sheath and on the guidewire; Figure 8 This is a schematic diagram illustrating how the closing device is positioned by pulling in the proximal direction; Figure 9 This is a schematic diagram showing the actuation of the actuator to release the pad and apply tension to the filament; Figure 10 This is a schematic diagram showing the tether that retracts the pad in the proximal direction; Figure 11 This is a schematic diagram showing the release of the pad after disengagement; Figure 12 This is a schematic diagram showing the deployment component being pulled in the proximal direction so that the pad is adjacent to the blood vessel wall; Figure 13 This is a schematic diagram showing the plug for deploying the closing device; Figure 14 This is a schematic diagram showing the locking component deployed by the plug; Figure 15 This is a schematic diagram showing the locking member being pressed firmly onto the plug using a compactor; and Figure 16 This is a schematic diagram showing a sealing device deployed to completely seal the puncture site. Detailed Implementation

[0011] The use of certain terms in the following description is for convenience only and not for limitation. The words “right,” “left,” “down,” and “up” indicate directions in the referenced figures. The words “proximal” and “farthest” refer to directions toward and away from the individual operating system, respectively. Terms include the words listed above, their derivatives, and words with similar meanings.

[0012] refer to Figures 1 to 4Embodiments of the vascular closure device 10 may include a sealing unit 18 and a retraction assembly 50, the sealing unit 18 being at least partially disposed within the deployment assembly 14. The vascular closure device 10 may be configured such that after the deployment assembly 14 is inserted into the vascular puncture site through the vascular puncture site, the sealing unit 18 may be deployed to thereby seal or otherwise close the vascular puncture site. After deployment but before the sealing unit 18 is in its final sealing configuration, the user can retract the pad 40 of the sealing unit 18 in a proximal direction using the retraction assembly 50. In particular, the retraction assembly 50 allows the user to withdraw or pull back the pad 40 in case of incorrect positioning or placement. Furthermore, the retraction assembly 50 also provides the ability to release from the deployment procedure and completely remove the pad 40 from the puncture site during use.

[0013] Deployment assembly 14 can be configured to control the orientation of the gasket 40 of sealing unit 18 during use. According to the illustrated embodiment, deployment assembly 14 includes a release member 22 that restricts the release of the gasket 40 (in... Figure 1 and Figure 2 (shown in dashed lines), delivery member 26, and one or more actuators, such as deployment actuator 38, wherein the delivery member 26 includes at least a portion of the pad 40 and the suture 44 of the sealing unit 18. Release member 22 may be operatively coupled or associated with the suture 44 such that actuating deployment actuator 38 causes release member 22 to: 1) release the pad 40, and 2) apply tension to the suture 44, which forces the pad 40 against the delivery member 26 and orients the pad 40 in a sealed position.

[0014] Go to Figure 3 The sealing unit 18 may include a pad 40 connected to the suture 44, a plug 88 connected to the suture 44 and spaced apart from the pad 40 in the proximal direction 4, and a locking member 230 on the suture 44 and proximal to the plug 88.

[0015] The pad 40 may include or define a distal end 41d and a proximal end 41p opposite to the distal end 41d, a first set of holes 56 configured to receive a suture 44, a guide member hole 57, and an engagement member (engagement portion or engagement feature) 58. As shown, the suture 44 may extend through the first set of holes 56 such that one end of the suture 44 can be formed as 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 may extend through the hole 57. In the implanted state, the pad 40 may be positioned adjacent to the inner surface of the blood vessel, and the locking member 230 may compress the pad 40 and the plug 88 against the outer surface of the blood vessel to seal the perforation. The guide member 15 may extend through the sealing unit 18 and may be configured to receive a guidewire 150, as will be discussed below. The retraction assembly 50 may be coupled to the pad 40 via the engagement member 58. Figure 4 As shown, in one example, the connecting member 58 may be or may include a hole through which the tether 52 may be knotted to the pad 40.

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

[0017] The plug 88 may comprise a compressible, reabsorbable collagen foam strip and may be made of a fibrous collagen mixture of insoluble and soluble collagen cross-linked together for strength. However, it should be understood that the sealing plug 88 may have any configuration as needed and may be made of any material as required. The suture 44 may be any elongated member, such as, for example, filaments, threads, or braids.

[0018] The deployment assembly 14, including the release component 22 and the delivery component 26, can be constructed and function according to the apparatus, system, and method disclosed in U.S. Patent No. 11,364,024, the entire contents of which are incorporated herein by reference. See again Figure 1 , Figure 2 and Figure 4The deployment component 14 may be elongated along the longitudinal direction L and may include a proximal end 16p and a distal end 16d spaced apart from the proximal end 16p along an axis 6 aligned with the longitudinal direction L. The longitudinal direction L may include and define a distal direction 2 extending from the proximal end 16p toward the distal end 16d. Furthermore, the longitudinal direction L may include and define a proximal direction 4 opposite to the distal direction 2 and extending from the distal end 16d toward the proximal end 16p. The deployment component 14 may be configured along the insertion direction I (see...). Figure 4 Insert the pad 40 into the blood vessel. During part of the sealing procedure, the longitudinal direction L can be aligned with the insertion direction I.

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

[0020] Deployment actuator 38 can be coupled to both handle member 20 and release member 22. Deployment actuator 38 can 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 deployment assembly 14 can be configured such that delivery member 26 is movable relative to release member 22. Deployment assembly 14 may also include guide member 15 and optional outer sheath 23 (see [link to documentation]). Figure 4 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 ).

[0022] Go to Figure 1 and Figure 2The 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. The 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 the delivery member 26, such that the release member 22 is movable relative to the delivery member 26. Embodiments of one or more of these features, including additional features of the 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] like Figures 2 to 4 As shown, the delivery component 26 can be coupled to the tensioner 28 and can extend along the release component 22 toward the distal end 16d of the deployment assembly 14. The delivery component 26 may include a delivery tube body that extends along a first direction L and defines a distal end and a proximal end, the proximal end being spaced apart from the distal end in the first direction L. The delivery tube body may define a delivery tube channel that extends at least partially through the delivery tube body along the first direction L. As shown, the proximal end of the delivery component can be secured to the tensioner 28, and the distal end of the delivery component can be configured to retain at least a portion of the sealing unit 18 (see Figure 1). Figure 4 Embodiments of one or more of these features are described in U.S. Patent No. 11,364,024, including additional features of the release member 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 4As 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 can define a cavity that receives the proximal end 41p of the pad 40 when the release member 22 is in this initial position. 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 is spaced apart in the distal direction 2 by a distance beyond the distal ends of the release member 22 and the delivery member 26, respectively. A suture 44 can extend from the pad 40 through the delivery tube channel and through the proximal end of the pulley surrounding the tensioner 28. A 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 will 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...). Figure 11 and Figure 12 In the sealed position, the gasket 40 has been repositioned such that, compared to its position when constrained by the release member 22, the gasket 40 is placed 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. For example, deployment actuator 38 may engage release member 22 such that movement of deployment actuator 38 relative to handle member 20 may cause release member 22 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] The retraction assembly 50 can be configured to retract the pad 40 in the proximal direction. The retraction assembly 50 may include a tether 52 attached to the pad 40 and a guide member 15 engaged with the pad 40.

[0029] The tether 52 can be or includes any elongated or extended element coupled to the pad 40. Thus, the tether can be an elongating or extended shaft, a suture, a filament, a thread, or a rod. In some examples, the tether 52 can resemble a release cord in form and / or function, such that pulling the tether 52 proximally can effectively abort the deployment of the sealing unit 18 if one or more components of the sealing unit 18 (such as the pad 40) are improperly positioned. In the illustrated embodiment, the tether 52 extends through the deployment assembly 14. However, in some configurations, the tether may extend along the deployment assembly 14. The retraction assembly may also include a retraction actuator 47 configured to pull the tether 52 in a proximal direction to retract the pad 40 at least in the proximal direction opposite to the distal direction. In one example, the actuator 47 can be a push-pull member that may include a rod and a thread. In another example, the actuator 47 can be a rotatable knob, a rotatable lever, or a slider. The tether 52, and therefore the proximal pull of the pad 40, can be triggered by the user in response to determining that the pad is not properly positioned in or near the vessel wall. In this way, the tether 52 can provide a disengagement mechanism for retracting the pad during surgery.

[0030] like Figure 5 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 is configured to receive a guidewire, such as guidewire 150 (see Figure 150), passing through it. Figures 6 to 10 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, in some examples, which may be manually engaged by a user.

[0031] After the pad 40 is deployed, the pad engagement member 68 abutting against the abutment of the pad 40 can cause the pad 40 to pivot in the proximal direction. More specifically, the retraction of the tether 52 and the advancement of the guide member 15 in the distal direction until the pad engagement member 68 abuts the proximal surface of the pad 44 can cause the pad 40 to pivot in the proximal direction.

[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...). Figure 11 and Figure 12 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] In some cases, the user may need to reposition the pad 40. In this case, the user can use typical visualization procedures (such as a puncture locator, radiography, or other means to identify the position of the pad) to determine the position of the pad 40 in the lumen of an artery or vein. The user can retract the pad 40 and remove it from the lumen of the artery or vein in a proximal direction toward the distal end of the deployment assembly. In this case, retracting the pad 40 in the proximal direction may further include retracting the tether (e.g., tether 52) attached to the pad. Alternatively, the user can advance the pad engagement member 68 of the guide member (e.g., guide member 15) against the proximal surface of the pad 40, causing the pad 40 to pivot for retraction in that proximal direction. The pad can retract rearward toward or into the delivery assembly. In some cases, the user can disengage the plug 88 from the deployment assembly, and this then causes the sealing plug 88 to retract rearward toward the distal end of the deployment assembly. In any case, after retracting the pad 40 in the proximal direction, the user can push the pad 40 back into the correct position in the distal direction toward the lumen of the artery or vein.

[0034] Embodiments of the present technology will now be described with reference to an exemplary large-aperture procedure utilizing the vascular closure device 10. To perform any relevant 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 to a sufficient distance to allow removal of the needle without pulling the guidewire 150 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 150 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 be moved into the blood vessel through the puncture site. Once properly positioned, the guide can be removed, leaving the sheath providing a fairly large access route from outside the body to inside the blood vessel.

[0035] 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. Figures 6 to 16 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).

[0036] Now for reference Figure 6 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 or component. For example, as Figure 6 As shown, the surgical sheath is 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 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 6 As shown, the ingress sleeve 208 can limit the distal end D. A Proximal P A and internal access channel 212, which is inserted 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.

[0037] like Figure 7 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) can be positioned 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.

[0038] 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. Figures 6 to 8 As shown. As mentioned above, in some cases, the pad 40 may not be in the correct position for sealing after it has been inserted into the target blood vessel. In this case, the user can determine the position of the pad 40. Figure 9 and Figure 10 As shown, in some examples, the user can retract the pad 40 proximally toward the distal end of the deployment assembly 14 and even exit from the lumen of an artery or vein. In this case, retracting the pad in this proximal direction further includes retracting the tether 52 attached to the pad 40. Furthermore, the user can advance the pad engagement member of the guide member against the proximal surface of the pad, causing the pad 40 to pivot to retract in this proximal direction, as shown. Figure 10 As shown. The pad 40 can retract rearward toward or into the delivery assembly 10. After retracting the pad in the proximal direction, the user can push the pad 40 back into the correct position in the distal direction toward the lumen of the artery or vein, as from... Figures 10 to 11 The progress is shown.

[0039] Once the pad 40 is adjusted to the correct position, the deployment actuator 38 can be actuated to release the pad 40 from the release tube, and tension is subsequently applied to the suture 44 to pull the pad 40 against the distal end of the delivery member 26, as... Figure 11As shown. At this point, the gasket 40 can be oriented in the sealing position.

[0040] With the pad 40 in the sealed position, the deployment assembly 14, together with the access sheath 208, can be pulled proximally so that the pad 40 is adjacent to the vessel wall 204, as... Figure 12 As shown. Figure 13 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, and can cause the plug 88 to substantially fill the puncture site 200, for example as... Figure 14 As shown. After the plug 88 comes into contact with the blood or other fluid within the puncture site 200, the plug 88 can expand and fill the remaining portion of the puncture site 200.

[0041] 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 15 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 and the locking member 230, 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 can be 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.

[0042] like Figure 15 and Figure 16 As further 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 15As 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, compactor 234, and other components of the sealing unit 18 can be removed from the puncture site 200, as shown. Figure 16 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.

[0043] 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.

[0044] 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.

[0045] 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 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 coupled to the suture. The pad may be configured to be located away from the distal end of the deployment assembly for deployment in the perforation. The closure device may also include a retraction assembly coupled to the pad, configured to retract the pad in a proximal direction after deployment.

[0046] 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 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 exit the deployment assembly for deployment in the perforation. The closure device may also include a tether attached to the pad, the tether being configured to retract the pad in a proximal direction after the pad has exited the deployment assembly.

[0047] 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, and a suture carried by the deployment assembly. The closure device may further include a pad carried by the deployment assembly and coupled to the suture. The pad may be configured to 1) exit from the deployment assembly for deployment, and 2) retract in a proximal direction after deployment. The closure device may also include a guide member having an elongated body and a pad engaging member configured to abut the pad. After deployment of the pad, the abutment of the pad engaging member against the abutment of the pad may cause the pad to pivot for retraction in the proximal direction.

[0048] In Example 4, the vascular closure device according to any one or any combination of Examples 1-3 can be configured such that the retraction assembly includes a tether attached to the pad.

[0049] In Example 5, the vascular closure device according to any one or any combination of Examples 1, 2 or 4 can be configured such that the retraction assembly includes a guide member that engages with the pad.

[0050] In Example 6, the vascular closure device according to one or both of Examples 2 or 4 can be configured such that the tether is a filament.

[0051] In Example 7, one or both of the vascular closure devices according to Example 2 or 4 can be configured such that the tether is a silk thread.

[0052] In Example 8, the vascular closure device according to one or both of Examples 2 or 4 can be configured such that the tether is an elongation axis.

[0053] In Example 9, one or both of the vascular closure devices according to Example 2 or 4 can be configured such that the tether extends through the deployment assembly.

[0054] In Example 10, one or both of the vascular closure devices according to Example 2 or 4 can be configured such that the tether extends along the deployment assembly.

[0055] In Example 11, the vascular closure device according to any one or any combination of Examples 1-10 can be configured such that the pad includes a coupling member, coupling portion or coupling feature attached to the distal end of the tether.

[0056] In Example 12, the vascular closure device according to any one or any combination of Examples 1-11 can be configured to further include a guiding member having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen is configured to receive a guidewire passing through it.

[0057] In Example 13, the vascular closure device according to one or both of Examples 3 or 12 can be configured such that the pad includes a hole through which the distal end of the guide member extends.

[0058] In Example 14, the vascular closure device according to any one or any combination of Examples 3, 12 and / or 13 can be configured such that the guiding member includes a pad engagement member, wherein the retraction of the tether and the adjacency of the pad engagement member with the proximal surface of the pad cause the tail end of the pad to pivot rearward toward the distal end of the deployment assembly.

[0059] In Example 15, the vascular closure device according to Example 14 can be configured such that advancement of the guide member in the distal direction until the pad engaging member abuts the proximal surface of the pad causes the pad to pivot in the distal direction toward the distal end of the deployment assembly.

[0060] In Example 16, the vascular closure device according to any one or any combination of Examples 3 and 12-15 can be configured such that the guide member includes a push engagement member configured to push the guide member in the proximal direction when a force is applied to the push engagement member.

[0061] In Example 17, the vascular closure device according to any one or any combination of Examples 2, 4 and 12-16 can be configured to further include an actuator configured to pull the tether in a proximal direction so as to retract the pad in at least a proximal direction opposite to the distal direction.

[0062] In Example 18, the vascular closure device according to Example 17 can be configured such that the actuator is a push-pull member.

[0063] In Example 19, the vascular closure device according to Example 17 can be configured such that the actuator is a rotatable knob.

[0064] In Example 20, the vascular closure device according to Example 17 can be configured such that the actuator is a rotatable lever.

[0065] In Example 21, the vascular closure device according to Example 17 can be configured such that the actuator is a slider.

[0066] In Example 22, the vascular closure device according to any one or any combination of Examples 1-21 can be configured to further include a sealing unit comprising a pad and a sealing plug coupled to the suture and positioned proximal to the pad.

[0067] In Example 23, the vascular closure device according to any one or any combination of Examples 1-22 can be configured to further include a movable lock along the suture and a compaction member capable of sliding along the suture, the compaction member being configured to cause the movable lock to slide into engagement with the sealing plug.

[0068] In Example 24, the vascular closure device according to any one or any combination of Examples 1-23 can be configured such that the deployment assembly 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 from the deployment assembly.

[0069] In Example 25, a vascular closure device according to any one or any combination of Examples 1-24 can be configured such that during retraction, the proximal end of the pad is aligned with the axis of the delivery device assembly.

[0070] In Example 26, a method for sealing a perforation in an artery or vein may involve inserting the distal end of a deployment assembly into the perforation of the artery or vein, causing a gasket of a sealing unit to exit the distal end of the deployment assembly and enter the lumen of the artery or vein. The method may further involve determining the position of the gasket within the lumen of the artery or vein, and causing the gasket to retract proximally toward the distal end of the deployment assembly and exit the lumen of the artery or vein.

[0071] In Example 27, the method according to Example 26 further involves pushing the sealing plug out of the deployment assembly and retracting the sealing plug toward the distal end of the deployment assembly.

[0072] In Example 28, the method according to Example 26 can be implemented such that retracting the pad in the proximal direction further involves retracting the tether attached to the pad.

[0073] In Example 29, the method according to Example 28 can be implemented such that retracting the pad toward the distal end of the deployment component further involves advancing a pad engagement member of the guide lumen or component against the proximal surface of the pad, thereby causing the pad to pivot to retract in the proximal direction.

[0074] In Example 30, the method according to Example 26 may further involve retracting the pad in the proximal direction and then advancing the pad toward the lumen of the artery or vein in the distal direction.

[0075] In Example 31, the method according to any one or any combination of Examples 26-30 may further involve inserting an access sheath into the 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.

[0076] In Example 32, the method according to any one or any combination of Examples 26-31 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.

[0077] In Example 33, the method according to any one or any combination of Examples 26-32 can be implemented such that the pad is limited by the release and delivery parts of the deployment assembly, wherein moving the pad away from the distal end of the deployment assembly may further involve moving either or both of the release and delivery parts relative to each other to release the pad from the deployment assembly.

[0078] In Example 34, the method according to any one or any combination of Examples 26-33 can be implemented such that retracting the pad in the proximal direction involves retracting the proximal end of the pad toward the distal end of the deployment assembly and exiting the lumen of the artery or vein.

[0079] In Example 35, the method according to any one or any combination of Examples 26-34 can be performed using a vascular closure device or a component thereof according to any one or any combination of Examples 1-25.

Claims

1. A vascular closure device configured to seal a perforation in an artery or vein, the vascular closure device comprising: A deployment component having a proximal end and a distal end opposite to the proximal end; A suture, the suture being carried by the deployment component; A pad, which is carried by the deployment assembly and coupled to the suture, wherein the pad is configured to be located away from the distal end of the deployment assembly for deployment in the perforation; and A retraction assembly is attached to the pad and configured to retract the pad in a proximal direction after the pad has been deployed.

2. The vascular closure device according to claim 1, wherein, The retraction assembly includes a tether attached to the pad.

3. The vascular closure device according to claim 1, wherein, The retraction assembly includes a guide member that engages with the pad.

4. The vascular closure device according to claim 2, wherein, The tether consists of fine filaments.

5. The vascular closure device according to claim 2, wherein, The tethering rope includes silk thread.

6. The vascular closure device according to claim 2, wherein, The tether includes an extension shaft.

7. The vascular closure device according to claim 2, wherein, The tether extends through the deployment component.

8. The vascular closure device according to claim 2, wherein, The tether extends along the deployment component.

9. The vascular closure device according to claim 2, wherein, The pad includes a connecting member that is attached to the distal end of the tether.

10. The vascular closure device of claim 1, further comprising a guiding member having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen is configured to receive a guidewire passing through it.

11. The vascular closure device according to claim 10, wherein, The pad includes a hole through which the distal end of the guide member extends.

12. The vascular closure device according to claim 11, wherein, The guiding member includes a pad engagement member, and wherein the retraction of the tether and the adjacency of the pad engagement member with the proximal surface of the pad cause the tail end of the pad to pivot rearward toward the distal end of the deployment assembly.

13. The vascular closure device according to claim 12, wherein, The advancement of the guide member in the distal direction until the pad engagement member abuts the proximal surface of the pad causes the pad to pivot, so as to retract in the distal direction toward the distal end of the deployment assembly.

14. The vascular closure device according to claim 13, wherein, The guiding member includes a propulsion engagement member configured to propel the guiding member in the proximal direction when a force is applied to the propulsion engagement member.

15. The vascular closure device of claim 14, further comprising an actuator configured to pull the tether in a proximal direction to retract at least the pad in a proximal direction opposite to the distal direction.

16. The vascular closure device according to claim 15, wherein, The actuator includes a push-pull member, a rotatable knob, a rotatable lever, or a slider.

17. The vascular closure device of claim 1, further comprising a sealing unit, the sealing unit including the pad and a sealing plug connected to the suture and positioned proximal to the pad.

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

19. The vascular closure device of claim 1, wherein the deployment component includes a release member and a delivery member, and wherein either or both of the release member and the delivery member are movable relative to the other to release the pad from the deployment component.

20. The vascular closure device according to claim 19, wherein, During retraction, the proximal end of the pad is aligned with the axis of the delivery device assembly.

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