Vascular occlusion devices with improved safety and hemostasis.

Abstract

A vascular occlusion device for achieving substantially immediate hemostasis at a puncture site in the blood vessel wall is disclosed, comprising an intravascular anchor having one or more suture attachment points, an extravascular cap having a lumen, a sealant, and a suture connected to at least one of the one or more suture attachment points of the intravascular anchor and penetrating the lumen of the extravascular cap, wherein each of the intravascular anchor, extravascular cap, sealant, and suture is formed of a bioabsorbable material. A delivery system for realizing such a vascular occlusion device is also disclosed.

Description

Technical Field

[0001] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 495,360, filed Apr. 11, 2023, and U.S. Utility Patent Application No. 18 / 630,600, filed Apr. 9, 2024, both entitled "VESSEL CLOSURE DEVICE WITH IMPROVED SAFETY AND TRACT HEMOSTASIS". Both applications are hereby expressly incorporated by reference in their entireties.

Background Art

[0002] 1. Field of the Invention The present disclosure generally relates to systems, devices, and methods for closing openings within a body cavity. More particularly, the present disclosure relates to techniques for percutaneous closure of arterial and venous puncture sites that are typically accessed via tissue tracts.

[0003] 2. Related Art Currently, many diagnostic and interventional vascular procedures are performed transvascularly. A catheter is introduced into the vascular system at an appropriate access location and guided through the vascular system to a target location using established techniques. Such procedures require vascular access, and such access is typically established by the well-known Seldinger technique. Vascular access is generally provided via an introducer sheath positioned to extend from outside the patient's body into the vascular lumen. Once vascular access is no longer needed, the introducer sheath is removed and bleeding at the puncture site is stopped.

[0004] One common method for hemostasis (stopping bleeding) is to apply external force near and upstream of the puncture site, typically by manual compression. This technique has several drawbacks. For example, manual compression is time-consuming, often requiring more than 30 minutes of compression to achieve hemostasis. Furthermore, such compression techniques rely on thrombus formation, which can be delayed until the anticoagulant used in vascular treatment procedures (e.g., myocardial infarction, stent placement, non-optical PTCA results) wears off. Anticoagulants can take 2-4 hours to wear off, which increases the time required to complete manual compression.

[0005] Manual compression is uncomfortable for the patient and often requires analgesics to make it bearable. Furthermore, applying excessive pressure can completely occlude the blood vessel, leading to ischemia and / or thrombosis. After manual compression, the patient is usually kept in a supine position for 4 to 12 hours or more, under close observation to ensure hemostasis is maintained. During this period, new bleeding may occur, potentially resulting in vascular blood loss, hematoma and / or pseudoaneurysm formation, and arteriovenous fistula formation. These complications may require blood transfusion and / or surgical intervention.

[0006] The incidence of complications from manual compression increases with larger introducer sheath sizes and / or if the patient is receiving anticoagulation therapy. Compression techniques for arterial occlusion can be risky, costly, and burdensome for patients. While the risk of complications can be mitigated by using highly trained personnel, dedicating such personnel to this task is costly and inefficient. Nevertheless, as the number and effectiveness of enterally performed diagnostic and interventional vascular procedures increase, the number of patients requiring effective hemostasis for vascular puncture continues to rise.

[0007] Vascular occlusion devices have been introduced to shorten the time to hemostasis, enable early ambulation, and improve patient comfort. Initially, these devices primarily involved techniques using sutures or collagen plugs. However, while these techniques close the hole or puncture site, they often leave residual elements within the blood vessel, which can lead to complications, such as residual bleeding or leakage from the tube. Persistent microbleeding is a common phenomenon. This bleeding usually requires direct management by a trained medical professional until it stops completely. Anticoagulants, which are typically administered to patients with catheters, can worsen bleeding and may require management with manual compression until the medication wears off. [Overview of the Initiative] [Means for solving the problem]

[0008] This application relates to a vascular occlusion device for achieving rapid hemostasis at a puncture site in the blood vessel wall. The vascular occlusion device may comprise an intravascular anchor having one or more suture attachment points, an extravascular cap having a lumen, a sealant, and a suture connected to at least one of the one or more suture attachment points of the intravascular anchor, through which the lumen of the extravascular cap is penetrated. Each of the intravascular anchor, extravascular cap, sealant, and suture may be formed from a bioabsorbable material.

[0009] This disclosure relates to a vascular occlusion device for achieving substantially immediate hemostasis at a puncture site in the vessel wall, the occlusion device comprising: an intravascular anchor having one or more suture attachment points; an extravascular cap having a lumen; a sealant; and a suture connected to at least one of the one or more suture attachment points of the intravascular anchor and screwed through the lumen of the extravascular cap and the sealant to connect the intravascular anchor to the extravascular cap and the sealant. Each of the intravascular anchor, extravascular cap, sealant, and suture may be formed from a bioabsorbable material.

[0010] The disclosure also relates to a vascular occlusion device having one or more elongated bodies having a flexible member and a keel. The elongated bodies may optionally include a number of ribs extending radially from the keel to a raised edge of the elongated body. The occlusion device also includes an extravascular cap formed of an elastomer material, a sealant formed of polyethylene glycol (PEG), a suture having a distal suture portion and a proximal suture portion, wherein the diameter of the lumen of the extravascular cap is smaller than the diameter of the distal suture portion, and an intravascular anchor.

[0011] In some embodiments, the closure device includes an intravascular anchor having one or more suture attachment points, an extravascular cap having a lumen, a sealant having a lumen, and a suture connected to at least one of the one or more suture attachment points of the intravascular anchor, passed through the lumen of the extravascular cap, and passed through the lumen of the sealant to connect the intravascular anchor to the extravascular cap and sealant. The suture may include a proximal suture portion and a distal suture portion, the distal suture portion having a diameter greater than the diameter of the lumen of the extravascular cap. The distal suture portion may form a crimp for locking the extravascular cap onto the puncture site, and each of the intravascular anchor, extravascular cap, sealant, and suture is formed of a bioabsorbable material.

[0012] The disclosure also relates to a vascular occlusion device comprising: an extravascular cap formed of a flexible material; a suture which is a braided suture; a sealant threaded through the suture in close proximity to the extravascular cap; the sealant which, when activated, locks the extravascular cap in place, coagulates the access route at the puncture site, and provides substantially immediate hemostasis; and an intravascular anchor which comprises one or more of the following: an elongated body; a raised keel located on the central axis of the elongated body and extending over the length of the elongated body (including optionally one or more suture attachment points); and a sealant formed of polyethylene glycol (PEG).

[0013] This disclosure also relates to a delivery system for realizing a vascular occlusive device to provide substantially immediate hemostasis at a puncture site in the vessel wall. The delivery system may include a handle assembly, a delivery assembly, and a vascular occlusive device. The handle and the delivery assembly are configured to engage with each other detachably to deliver the vascular occlusive device to the puncture site.

[0014] The disclosure also relates to intravascular anchors for vascular occlusion devices for substantially immediate hemostasis at a puncture site in the vascular wall. In some embodiments, the intravascular anchor comprises an elongated body having a flexible membrane for conforming to the wall of a vascular vessel, and a keel having one or more suture attachment points, the keel being an elongated member centrally positioned along the central axis of the elongated body, and the intravascular anchor comprises a bioabsorbable material.

[0015] These and other purposes and features of the present disclosure will become more fully apparent from the following description and the appended claims, or may be known by the practice of the invention in the forms set forth below.

[0016] A description of the various aspects and features of this disclosure is provided by reference to the various representative embodiments shown in the accompanying drawings. It is understood that these drawings illustrate only typical embodiments of the invention and should therefore not be considered to limit its scope. [Brief explanation of the drawing]

[0017] [Figure 1A] This shows a delivery system in which a closure device can be implemented according to one embodiment. [Figure 1B] This shows a delivery system in which a closure device can be implemented according to one embodiment. [Figure 1C] This shows a delivery system in which a closure device can be implemented according to one embodiment. [Figure 1D] This disclosure provides an alternative delivery system for deploying the closure device. [Figure 1E] Figure 1D shows a partial cross-sectional view of the alternative delivery system. [Figure 1F] Shows a schematic diagram of another alternative delivery system according to the present disclosure. [Figure 2A] Shows an exemplary embodiment of a closure device. [Figure 2B] Shows an exemplary embodiment of a closure device. [Figure 3A] Shows an embodiment of a cap of a closure device. [Figure 3B] Shows a cross-sectional view of the cap of FIG. 3A. [Figure 3C] Shows a cap having an adhesive layer similar to that of FIG. 3A. [Figure 3D] Shows a cross-sectional view of the cap of FIG. 3C. [Figure 4] Shows a cross-sectional view of a closure device applied to a blood vessel. [Figure 5] Shows a cross-sectional view of a closure device applied to a blood vessel through an access path. [Figure 6A] Shows a cross-sectional view of a closure device applied to a blood vessel through an access path. [Figure 6B] Shows a cross-sectional view of a closure device applied to a blood vessel through an access path. [Figure 7A] Shows an embodiment of an intravascular anchor of a closure device. [Figure 7B] Shows an embodiment of an intravascular anchor of a closure device. [Figure 7C] Shows an embodiment of an intravascular anchor of a closure device. [Figure 7D] Shows an embodiment of an intravascular anchor of a closure device. [Figure 7E] Shows an alternative embodiment of an intravascular anchor of a closure device. [Figure 7F] Shows an alternative embodiment of an intravascular anchor of a closure device. [Figure 7G] Shows an alternative embodiment of a closure device. [Figure 7H] Shows an alternative embodiment of a closure device. [Figure 8A] Shows the side facing the lumen of an alternative embodiment of an intravascular anchor. [Figure 8B] Shows the side facing the intima of the embodiment of the intravascular anchor of FIG. 8A. [Figure 9A] This shows the side of another embodiment of an intravascular anchor facing the lumen. [Figure 9B] Figure 9A shows the side facing the intima of the intravascular anchor embodiment. [Figure 10A] This shows the side of another embodiment of an intravascular anchor facing the lumen. [Figure 10B] Figure 10A shows the side facing the intima of the intravascular anchor embodiment. [Figure 11A] This shows how to deliver a closure device to the access site of a blood vessel. [Figure 11B] This shows how to deliver a closure device to the access site of a blood vessel. [Figure 11C] This shows how to deliver a closure device to the access site of a blood vessel. [Figure 11D] This shows how to deliver a closure device to the access site of a blood vessel. [Figure 12] An alternative embodiment of the delivery system for occlusion devices is shown. [Figure 13A] Figure 12 shows a side view of the handle assembly of the delivery system. [Figure 13B] Figure 12 shows a side view of the handle assembly of the delivery system. [Figure 13C] Figures 13A and 13B show perspective views of the handle assembly. [Figure 13D] Figures 13A to 13C show top views of the handle assembly. [Figure 13E] Figures 13A to 13D show cross-sectional views of the handle assembly. [Figure 13F] Figure 13E shows an enlarged view of the handle assembly area 13F. [Figure 14A] Figure 13C shows an exploded view of the handle assembly of the delivery system. [Figure 14B] Figures 12 to 14A show enlarged views of the handle assembly chamber. [Figure 14C] Figures 13A to 13E show cross-sectional perspective views of the handle assembly with the implant assembly removed from it. [Figure 14D] Figure 14C shows a cross-sectional view of the slider in the implant assembly. [Figure 14E] Figure 14D shows a perspective view of the slider located inside the handle body. [Figure 14F] Figure 14D shows a perspective view of the slider located inside the handle body. [Figure 15] Figures 14A and 14C show enlarged views of the implant assembly. [Figure 16] Figure 14C shows an exploded view of the implant assembly. [Figure 17A] The diagram shows the dilator tube and dilator hub for placing the occlusion device. [Figure 17B] The diagram shows the dilator tube and dilator hub for placing the occlusion device. [Figure 18A] This shows the delivery sheath and sheath hub of the delivery system. [Figure 18B] This shows the delivery sheath and sheath hub of the delivery system. [Figure 19A] This shows the insertion and mounting of the handle assembly into the delivery sheath and sheath hub. [Figure 19B] This shows the insertion and mounting of the handle assembly into the delivery sheath and sheath hub. [Figure 19C] Figure 19A shows the delivery system in a partially unfolded state. [Figure 19D] Figure 19C shows a close-up view of the implant assembly partially unfolded from the delivery sheath. [Figure 20A] The diagram shows the dilator tube and dilator hub being inserted into the delivery sheath and sheath hub according to the method of delivering the occlusion device to the vascular access site. [Figure 20B] The diagram shows the dilator tube and dilator hub being inserted into the delivery sheath and sheath hub according to the method of delivering the occlusion device to the vascular access site. [Figure 21A]This diagram shows a combination of a dilator tube and a delivery sheath inserted through a tissue pathway, according to the method of delivering a closure device to the vascular access site. [Figure 21B] This shows a delivery sheath within a tissue pathway, following the method for delivering a closure device to the vascular access site. [Figure 21C] The diagram shows the delivery sheath and the handle assembly connected to the sheath hub, according to the method of delivering the closure device to the access site on the blood vessel. [Figure 21D] The diagram shows the delivery sheath and the handle assembly connected to the sheath hub, according to the method of delivering the closure device to the access site on the blood vessel. [Figure 22] This shows a partial deployment of an occluding device according to the method of delivering the occluding device to the access site of a blood vessel. [Figure 23A] The deployment of the closure device and subsequent removal of the handle assembly and delivery sheath are shown according to the method of delivering the closure device to the vascular access site. [Figure 23B] The deployment of the closure device and subsequent removal of the handle assembly and delivery sheath are shown according to the method of delivering the closure device to the vascular access site. [Figure 23C] The deployment of the closure device and subsequent removal of the handle assembly and delivery sheath are shown according to the method of delivering the closure device to the vascular access site. [Figure 24A] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24B] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24C] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24D]This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24E] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24F] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24G] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24H] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24I] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24J] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24K] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24L] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24M] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24N] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24O] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24P] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 24Q] This shows an embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site. [Figure 25A] Figures 24A to 24Q show the bottom views of the latch assemblies. [Figure 25B] Figures 24A to 24Q show the bottom views of the latch assemblies. [Figure 25C] Figures 24A to 24Q show the bottom views of the latch assemblies. [Figure 26A] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 26B] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 26C] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 26D] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 26E] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 26F] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 27A] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 27B] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 27C] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 27D] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 27E] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 27F] Another embodiment of a latch or interlock assembly used with a handle assembly for delivering a closure device to a vascular access site is shown. [Figure 28A] This document describes an alternative embodiment of an external actuator or slider mechanism that can be used as part of a handle assembly for delivering a closure device to a vascular access site. [Figure 28B] This document describes an alternative embodiment of an external actuator or slider mechanism that can be used as part of a handle assembly for delivering a closure device to a vascular access site. [Figure 28C] This document describes an alternative embodiment of an external actuator or slider mechanism that can be used as part of a handle assembly for delivering a closure device to a vascular access site. [Figure 28D] This document describes an alternative embodiment of an external actuator or slider mechanism that can be used as part of a handle assembly for delivering a closure device to a vascular access site. [Figure 29A]Perspective and exploded views of alternative embodiments of a delivery system including a dual slider are shown, respectively. [Figure 29B] Perspective and exploded views of alternative embodiments of a delivery system including a dual slider are shown, respectively. [Figure 29C] Figure 29B shows a cross-sectional view of the delivery system through the chamber assembly. [Figure 29D] Figures 29A and 29B show perspective views of the delivery system after the dilator assembly has been removed and the sheath hub has been coupled to the housing. [Figure 30A] The diagrams show perspective and exploded views of alternative embodiments of a delivery system consisting of a single slider, respectively. [Figure 30B] The diagrams show perspective and exploded views of alternative embodiments of a delivery system consisting of a single slider, respectively. [Figure 30C] Figures 30A and 30B show perspective views of the delivery system after the dilator assembly has been removed and the sheath hub has been coupled to the housing. [Figure 31A] The diagrams show perspective and exploded views of alternative embodiments of a delivery system consisting of a single slider, respectively. [Figure 31B] The diagrams show perspective and exploded views of alternative embodiments of a delivery system consisting of a single slider, respectively. [Figure 31C] Figures 31A and 31B show perspective views of the delivery system after the dilator assembly has been removed and the sheath hub has been coupled to the housing. [Modes for carrying out the invention]

[0018] One or more specific embodiments of this disclosure are described below. To provide a concise description of these embodiments, some features of the actual embodiments can be described herein. It should be understood that in developing such actual embodiments, many embodiment-specific decisions are made, which may differ from embodiment to embodiment, such as compliance with system-related and business-related constraints, in order to achieve the specific goals of the developers, as in engineering or design projects. It should be further understood that although such development efforts may be complex and time-consuming, they are nevertheless routine design, fabrication, and manufacturing tasks for those skilled in the art who are interested in this disclosure.

[0019] One or more embodiments of the present disclosure may generally relate to devices, systems, and methods for delivering occluding devices or occluding implants configured to close an opening formed in tissue (e.g., a puncture into a blood vessel). The occluding devices or occluding implants are configured to provide immediate or substantially immediate hemostasis at the opening. Immediate or substantially immediate homeostasis can be achieved by “clamping” the occluding device or occluding implant around the opening. The disclosed occluding devices or occluding implants are also configured to deliver hemostatic agents or sealants to the access route in the tissue to eliminate or reduce track leakage. The configuration of the disclosed occluding devices or occluding implants is such that the disclosed occluding devices or occluding implants also have improved resistance to disruption and potential embolism, so that extravascular components can be prevented from passing through the puncture site.

[0020] One or more embodiments of the present disclosure may also generally be devices, systems, and methods for closing openings, such as punctures in the wall of a blood vessel. Embodiments of the present disclosure include a closure device or closure implant, a portion of which remains temporarily in the patient to close the opening. The portion remaining in the patient is subsequently broken down, absorbed, or reabsorbed in the tissue over a period of time.

[0021] This disclosure describes specific embodiments of apparatus and systems having associated methods for closing tissue openings, but it should be understood that any of the systems, apparatus, and methods described herein may be applicable to other uses, including but not limited to closing existing or formed openings in tissue or body cavities at other locations within a patient's anatomical structure. Furthermore, elements described in relation to any embodiment illustrated and / or described herein may be combined with elements described in relation to any other embodiment illustrated and / or described herein.

[0022] Vascular occlusion delivery system This disclosure relates to, for example, devices, systems, and methods for closing openings in the walls of blood vessels. For example, in one configuration, this disclosure includes an anchor, such as an intravascular anchor formed from a bioabsorbable, bioreabsorbable, and / or biodegradable material. The anchor can pass through an opening (e.g., a puncture) defined in the wall of a blood vessel and be deployed into the lumen of the blood vessel. The anchor can then be retracted proximally to make contact with the inner surface of the blood vessel wall. A closure element, such as a cap, can then be deployed on the outer surface of the blood vessel wall to close the puncture.

[0023] In at least one example, once placed in a blood vessel, the anchor (and optionally the cap) can be broken down, absorbed, or reabsorbed within a predetermined time. For example, this could be approximately 36–72 hours, less than 48 hours, less than approximately 36 hours, 1 day, less than 1 hour, or any other desired time, or a time within a range established by any two of the aforementioned values. The rate of breakdown, absorption, and / or reabsorption can be selected to correspond to the rate of anticoagulant inactivation. Rapid breakdown, absorption, or reabsorption of one or more components of the device allows the anchor to remain in place after the closure device or closure implant has been deployed, for example, by eliminating the need for anchor removal. By leaving the anchor in place until it breaks down, absorbs, or reabsorbs, damage that could occur by pulling the anchor through the puncture and / or deployed closure element that is currently closing can be reduced or eliminated. The anchor also allows the opening to be closed without cross-contamination from outside the blood vessel and / or other components.

[0024] Furthermore, the time required for the breakdown, absorption, or reabsorption of the anchor may fall within the duration of action of the antithrombotic drug used in conjunction with the patient's treatment. For example, the breakdown, absorption, or reabsorption of the anchor may occur before the administered antithrombotic drug is substantially metabolized by the patient. Therefore, the occlusion devices or occlusion implants of this disclosure can reduce the risk of intraarterial thrombus formation associated with the closure of a vascular puncture site.

[0025] One or more components of a vascular occlusion device may be broken down, absorbed, or reabsorbed within a predetermined time. For example, one or more components of a vascular occlusion device may be broken down, absorbed, or reabsorbed within a period established by 1 to 8 months, 2 months, 3 months, 3.5 months, 6 months, or any two of the aforementioned values.

[0026] While we have discussed anchors that remain within the blood vessels and are subsequently broken down, absorbed, or reabsorbed by the patient's body, it will be understood that in other configurations, the anchor can be deployed and then removed after the puncture has been adequately closed.

[0027] Herein, we refer to Figures 1A to 1B, which show an example of an occlusion device delivery system or occlusion implant delivery system 30. As shown in Figures 1A to 1B, the delivery system 30 may include a delivery sheath 40 having a set of actuators 50, 60, and 70. The set of actuators 50, 60, and 70 may be configured to cooperate in deploying the occlusion device or occlusion implant 100. The occlusion device or occlusion implant 100 may include an anchor 108 such as an intravascular "foot" or anchor, an occlusion element such as a cap 102, a fluid-blocking component 104 such as a sealant (see Figures 1B and 2A to 4), and a suture element 106. The terms fluid-blocking component and sealant are used interchangeably herein.

[0028] In some embodiments, the anchor 108 can be deployed using actuator 50, the cap 102 can be deployed using actuator 60, and the fluid shut-off component 104 can be deployed using actuator 70. In at least one embodiment, the delivery sheath 40 is configured to house the anchor 108, the cap 102, and the fluid shut-off component 104, and the actuators 50, 60, and 70 are configured to deploy the anchor 108, the cap 102, and the fluid shut-off component 104 from the delivery sheath 40, respectively. An exemplary delivery sheath 40, actuators 50, 60, 70, anchor 108, and closing device 100 shown in Figure 1A will be described in more detail with reference to Figure 1B.

[0029] Figures 1A and 1B illustrate a set of actuators 50, 60, and 70 arranged coaxially within a delivery sheath 40, although the actuators 50, 60, and 70 can be arranged non-coaxially within the delivery sheath 40. For example, as shown in Figures 1D and 1E, actuator 50 can be positioned laterally to actuator 60. Furthermore, the following description provides one method in which a particular actuator can be used to deploy the anchor 108, cap 102, and fluid isolation component 104, although it will be understood by those skilled in the art that one of the actuators 50, 60, and 70 can deploy any combination of the anchor 108, cap 102, and fluid isolation component 104 in any order or sequence. For example, actuator 60 can deploy the cap 102 and actuator 70 can deploy the fluid shut-off component 104, but in other configurations, one of the actuators, such as actuator 70, can be omitted, and actuator 60 can deploy the cap 102 and advance the fluid shut-off component 104 toward the cap 102, and the fluid shut-off component 104 can be deployed by a combination of distal and / or proximal movements relative to the anchor 108.

[0030] In other configurations, the delivery system 30 may include two or more actuators, such as two or more of actuators 50, 60, or 70, to deliver or deploy the anchor 108, cap 102, and fluid blocking component 104. Other combinations of deployment functions may also be performed by other individual actuators or combinations thereof.

[0031] Figure 1B shows an exploded view of the delivery system 30. As shown in Figure 1B, the delivery sheath 40 includes an outer housing 42 and a handle or grip portion 44. Each of the actuators 50, 60, and 70 includes a shaft or housing portion 52, 62, and 72, a handle or grip portion 54, 64, and 74, and a distal end that can cooperate with an anchor 108, a cap 102, and a fluid shutoff component 104, respectively. For example, actuator 50 may include a notch 58 for accommodating a suture 106 and optionally a portion of the anchor 108. A lumen 46 configured to accommodate the actuators 50, 60, and 70 is defined within the outer housing 42 so that the actuators 50, 60, and 70 can extend from the distal end 48 of the outer housing 42 and retract from there.

[0032] Each actuator 50, 60, 70 also includes a lumen 56, 66, 76, respectively, to allow parallel movement of the actuators 50, 60, 70 (independently or in combination of two or more actuators) and the delivery sheath 40. One or more lumens of one or more actuators 50, 60, 70 may include one or more valves or seals 55, 65, 75, and the delivery sheath 40 may also include one or more valves or seals 45 to prevent blood from flowing out of the delivery sheath 40 and the ends of the actuators 50, 60, 70. The parallel movement distance of the actuators 50, 60, 70 may be controlled, if necessary, by contact between adjacent handles or grip portions 44, 54, 64, 74. For example, grip portion 44 can restrict the distal movement of grip portions 54, 64, and 74, respectively, associated with actuators 50, 60, and 70; grip portion 74 can restrict the distal movement of grip portions 54 and 64, respectively; and grip portion 64 can restrict the movement of grip portion 54. In this way, excessive parallel movement of individual actuators is restricted, and the anchor 108, cap 102, and fluid blocking component 104 can be effectively deployed to access and close tissue openings.

[0033] While the description refers to a handle or grip portion that restricts the translation of an actuator, it is understood that other methods may be used to control the translation. For example, complementary structures may be formed in the housing and / or lumen to restrict the translation. In another configuration, the handle or grip portion is combined with a single handle assembly having different actuation control units such as switches, knobs, and sliders to enable the independent or combined movement of one or more of the actuators 50, 60, and 70.

[0034] In an alternative configuration, as shown in Figure 1C, the lumen 46' of the housing 42' may include a first portion 46A' configured to accommodate the distal end 52A' and the shaft portion 52' of the actuator 50'. A second portion 46B' of the lumen 46' may be configured to accommodate the proximal shoulder portion 52B' of the shaft portion 52' having the lumen 56'. The proximal shoulder portion 52B' may be part of the handle 54'. More specifically, the second portion 46B' of the lumen 46' may have a widthwise dimension greater than the widthwise dimension of the first portion 46A'. The widthwise dimensions of the first portion 46A' and the second portion 46B' may be their diameters or other cross-sectional profiles that are substantially perpendicular to the central axis C of the delivery sheath 40'. For ease of reference, the central axis C of the delivery sheath 40' is referred to when describing the position and movement of other components described herein. In the illustrated example, the lumen 46' can transition from the smaller diameter of the first section 46A' to the second larger diameter of the second section 46B' in the shoulder portion 46C'.

[0035] Such a configuration allows the actuator 50' to move axially parallel to the delivery sheath 40' within a desired range of motion. In particular, the proximal shoulder portion 52B' moves in parallel within the second portion 46B' of the lumen 46', advancing the shaft portion 52' within the outer housing 42' relative to the handle or grip portion 44', thereby moving the distal end 52A' of the shaft portion 52' relative to the distal end 42A' of the outer housing 42'. The interaction between the handle portion 54' and the shoulder portion 46C' can help prevent the distal end 52A' from extending beyond a desired position within the outer housing 42'.

[0036] In the illustrated example, the first portion 46B' may also be configured to accommodate the anchor 108 and cap 102. Thus, as the distal end 52A' of the shaft portion 52' advances toward the distal end 42A' through the first portion 46B', the distal end 52A' of the shaft portion 52' engages with the anchor 108 and / or cap 102, allowing the anchor 108 and / or cap 102 to move distally from the outer housing 42' and outward from the distal end 42A'. In this way, the anchor 108 and / or cap 102 are delivered to the puncture site.

[0037] Returning to Figure 1A, anchor 108 may be configured to move from a pre-deployment state having a width dimension before deployment to a deployed state having a width dimension after deployment. Anchor 108 is shown in the deployed state. The width dimension after deployment may be greater than the width dimension before deployment. Anchor 108 may have any configuration that allows for this difference in width dimension. In the illustrated example, anchor 108 rotates or is configured to rotate between the pre-deployment state and the deployed state. In other examples, part or all of anchor 108 may be configured to unfold from a pre-deployment state having a width dimension before deployment to a deployed state having a width dimension after deployment that is greater than the width dimension before deployment. For example, anchor 108 may include one or more arms or wings that can be configured to unfold and fold around a plurality of pivot points, hinges, living hinges, bending positions, preferred bending positions, and combinations or modifications thereof.

[0038] As shown in Figure 1A, the anchor 108 includes wing members 132, 134 that form the major axis 136 of the anchor 108. The anchor 108 may further include one or more holes or eyelets 138 arranged along the length of the anchor 108. The holes or eyelets 138 may be positioned to rotate the anchor 108 when a force initially acting parallel to the major axis 136 is applied to the eyelets 138. Such a configuration allows the anchor 108 to move from a state where the major axis 136 is aligned with the central axis C (see Figures 1C and 7A-7H) to a state where the major axis 136 is oriented more obliquely to the central axis C, such as nearly perpendicular to the central axis C. As shown in Figure 1A, the anchor 108 is substantially perpendicular to the central axis C.

[0039] This rotation can be achieved by first applying a distal force to the anchor 108 to move it away from the outer housing 42. Then, a proximal force can be applied to the anchor 108 through the interaction between the suture 106 and the eyelet 138. In at least one example, the distal force applied to the anchor 108 can be provided by the actuator 50, and the proximal force can be applied by the suture element 106. Thus, the anchor 108 can be used to position the delivery system 30 to deploy the closure element 102.

[0040] In one embodiment, the closure element 102 may be configured to close an opening in the blood vessel wall (e.g., a puncture) and at least partially occlude a tissue pathway from the outer surface of the tissue to the opening. The shape of the closure element 102 may be configured to be housed within the lumen 46 (and / or one of the other lumens of actuators 50, 60, 70). For example, the closure element 102 can conform to the shape of the lumen 46. In one embodiment, the closure element 102 may be substantially cylindrical before being deployed from the delivery sheath 40. That is, portions of the closure element 102 (e.g., peripheral portions) are at least partially wrapped around or curved toward the central portion of the closure element 102. These peripheral portions may be curved proximal, distal, and / or transversely with respect to the deployment direction of the closure element 102, such deployment direction toward the previously deployed anchor 108. When deployed from the delivery sheath 40, at least a portion of the closure element 102 can conform at least partially to the shape of the vessel wall, thereby closing the opening of the vessel and / or tissue pathway leading to the lumen opening.

[0041] The suture element 106 can pass through the anchor 108 in a loop such that the suture element 106 passes through or near the closure element 102 and extends proximal to or outward within the housing portion 52 of the actuator 50. In at least one embodiment, the free end of the suture element 106 passes through a separate portion or channel of the closure element 102. The suture element 106 can extend from the closure element 102 through the lumen 56 into the actuator 50.

[0042] In general, the structure and components of the delivery system 30 may be formed from polymers, metals, alloys, combinations thereof, or modifications thereof. For example, the delivery sheath and actuator may be formed from a metal hypo tube, a polymer tube, a composite tube having a multilayer structure, or other tubular structures, optionally including reinforcing members or braids. The outer diameter of the delivery sheath and actuator may be in the range of about 6F to about 10F, about 2mm to about 4mm, about 2mm to about 3.33mm, or other sizes known to those skilled in the art.

[0043] Figure 1F schematically shows an example of a fluid-blocking component or sealant 104 housed in a chamber 103. The chamber 103 is located or positioned at the proximal end of the delivery system 30. The sealant 104 is housed in the chamber 103 and configured to be moved distally through the delivery system 30 via an actuator 70. For example, the actuator 70 engages with the sealant 104 and advances it distally through the chamber 103, distally through the funnel 105, and distally from there. Once the sealant 104 has advanced through the funnel 105, it advances along and through the actuator 60 housed in the delivery sheath 40. As described herein, once distal to the actuator 60 and thus the delivery sheath 40, the sealant 104 may be exposed to blood and / or other body fluids for activation.

[0044] Vascular closure device Figures 2A and 2B show examples of occlusion devices or occlusion implants 100. In some embodiments, the occlusion device 100 may be a fully bioabsorbable vascular occlusion implant including intravascular and extravascular components. The extravascular components may include an occlusion element or cap 102 (hereinafter referred to as the "extravascular cap" or "cap") and a fluid-blocking component 104 such as a bioabsorbable sealant (see Figures 4 to 6B). The intravascular components may include an intravascular foot or anchor 108 and sutures 106, both of which may be bioabsorbable. As described above, in other configurations, the anchor 108 may be temporarily deployed, and the extravascular components may be fully bioabsorbable (e.g., by decomposition, absorption, and / or reabsorption).

[0045] As shown in the figure, the cap 102 includes a central lumen 110, a raised portion 113, and a cap surface 111. In some embodiments, the lumen 110 is sized to accommodate the diameter of the suture 106. In some embodiments, the lumen 110 is sized to accommodate the diameters of the two free ends of the suture 106 (for example, as shown in Figure 2B). The suture 106 can pass distally through the lumen 110, through the anchor 108, then proximal, and then back through the lumen 110 (indicated by the dotted line portion of the suture 106). Thus, both free ends of the suture 106 extend proximal from the cap 102.

[0046] The anchor 108 includes a keel 120 (described in more detail below) and a surface 129. As discussed elsewhere, the suture 106 is passed through a hole or eyelet in the anchor 108, thereby allowing the suture 106 to be fixed to the anchor 108. Such a configuration also allows any force applied to the suture 106 (i.e., pulling or tautting the suture 106) to be transmitted to the anchor 108. For example, if a physician or practitioner applies a proximal tensile or traction force to the suture 106, the proximal tensile or traction force is applied to the anchor 108, causing the anchor 108 to move proximal.

[0047] As shown in Figure 2B, the suture 106 may be braided with itself or otherwise intertwined before looping back through the lumen 110 of the cap 102. This results in a thicker suture portion 112. Additionally, and / or alternatively, the thicker suture portion 112 may be formed by or engaged with an elongated member 107. The thicker suture portion 112 can then form an interlocking fit with the lumen 110. Such a fit prevents the cap 102 from advancing undesirably distally beyond the desired position. In some embodiments, two sutures 106 may be passed through the cap 102 (through the lumen 110) and either pass through or cooperate with the elongated member 107. The two sutures 106 may be braided with and / or together with the elongated member 107 to form a thicker suture portion 112.

[0048] In any case, the formed thick suture portion 112 (i.e., two adjacent non-braided suture rails, two adjacent braided suture rails, a braided suture and an elongated member, or a suture end braided onto another part of the suture after being braided through two or more holes in the anchor 108) can form an interlocking fit with the narrow lumen 110 relative to the thick suture portion 112 in order to secure the cap 102 in the desired position. The thick suture portion 112 can have diameters ranging from approximately 0.020 inches (0.508 mm) to approximately 0.040 inches (1.016 mm), approximately 0.024 inches (0.6096 mm) to approximately 0.034 inches (0.8636 mm), and approximately 0.028 inches (0.7112 mm) to approximately 0.030 inches (0.762 mm).

[0049] The suture 106 may be made from a bioabsorbable material. For example, the suture 106 may be a multifilament or braided absorbable suture, such as those available from VITREX®. In one configuration, the suture is a braided 3-0 suture. It is advantageous that the suture has high tensile strength that can maintain integrity even when a force of about 3 pounds (lbf) to about 6 lbf is applied, but other sutures can accommodate force applications in the range of about 1 lbf to about 16 lbf, about 1 lbf to about 8 lbf, about 2 lbf to about 6 lbf, about 2.5 lbf to about 5 lbf, or about 2 lbf. Any two other ranges between such values ​​are also possible.

[0050] The extravascular cap 102 may be made from a bioabsorbable material and can be sized and shaped to prevent it from passing through the puncture access site 18 on the surface of the blood vessel 10 (see Figures 5 and 6A). The size and geometric shape of the cap 102 can significantly enhance patient safety by preventing the extravascular component from passing through the access site 18 during and / or after deployment. The cap 102 may have a diameter in the range of approximately 1 mm to 10 mm, approximately 3 mm to 8 mm, approximately 4 mm to 5 mm, or a range established by any two of the aforementioned values. The cap 102 may have different sizes and shapes based on the specific dimensions of the access site 18 to prevent the cap 102 from passing through the puncture site or access site 18 and entering the lumen of the blood vessel.

[0051] The cap 102 is thin and can be made from a biodegradable material. The cap 102 can also conform to the anatomical structure of the access site 18 (especially in vessels with significant calcification) and may have the flexibility desired to provide a more effective seal than a rigid material. The cap 102 can be deployed through the access tissue pathway 22 and positioned over the vessel 10 (see Figures 4-6B) to function as a major extravascular seal.

[0052] Looking at Figures 3A and 3B, one configuration of the cap 102 is illustrated. As shown, the shape of the cap 102 is a substantially circular disc shape and can have a consistent outer circumference or circumference. In other embodiments, the shape of the cap 102 can be discontinuous (e.g., star-shaped), which can provide flexibility to the cap 102 and allow it to fit into typically narrow access passages 22. The cap 102 may include an intermediate portion 113 that is raised relative to the surrounding surface 111 of the cap 102. Alternatively, as shown in Figures 3C and 3D, the intermediate portion 113 may provide a dome shape to the cap 102, while the rest may be continuous and smooth with the surrounding surface 111.

[0053] The intermediate portion 113 can have a thickness of approximately 0.050 mm to 5 mm, approximately 0.10 mm to 2 mm, approximately 0.10 mm to 0.5 mm, or various other thicknesses. The cap surface 111 may include relief cuts 115 that facilitate improved flexibility and fit of the cap to the access passage 22 leading to the blood vessel 10.

[0054] The relief cut 115 can extend radially around the longitudinal axis of the cap 102 and may be inclined along the surrounding surface 111, curved, or non-linear, or a combination and / or modified form thereof. Alternatively, or in addition to the relief cut 115, the relief cut 115a may have a generally circular form positioned around the intermediate portion 113, partially penetrating the thickness of the cap 102 and surrounding, enclosing, and / or annularly surrounding all or part of the intermediate portion 113. The relief cut 115a can alter the flexibility of the surface 111 to improve the fit of the cap 102 to the access passage 22 and resist the entry of the cap 102 into the blood vessel. The cap 102 may have a mass in the range of about 4.0 mg to about 10.0 mg (for caps with a diameter of 4 mm to about 6 mm). A smaller overall mass means that, for example, less force is required to hold the cap 102 in place via frictional engagement between the cap 102 and the suture 106. This allows the entire system to be smaller and lighter, thereby making it easier to position the closure device 100 within the patient and potentially reducing its overall impact on the patient's recovery process.

[0055] The access passage 22 (see Figures 4-6B) is typically limited in size, circular, and formed obliquely to the vessel wall. The cap 102 can be configured to slide downward through the access passage 22 via the delivery system 30 and be placed at the top of the vessel 10. The suture 106 can then be pulled to draw the cap 102 and the intravascular anchor 108 toward each other, thereby sealing the access site 18. As shown in Figures 3A-3D, the cap 102 may include a lumen 110 in its middle section 113 through which the suture 106 can be passed to attach the suture 106 to the anchor 108. The lumen 110 can have a diameter ranging from approximately 0.010 inches (0.254 mm) to approximately 0.020 inches (0.508 mm), approximately 0.012 inches (0.3048 mm) to approximately 0.017 inches (0.4318 mm), or approximately 0.014 inches (0.3556 mm) to approximately 0.015 inches (0.381 mm).

[0056] As described above, the lumen 110 can be sized to accommodate a suture 106 having a specific diameter. For example, as shown in Figures 2A-2B, with the suture 106 looped around the anchor 108, two rails or portions of the suture 106 can pass through the lumen 110 and advance proximal along the delivery device 30. Optionally, portions of the two sutures 106 may be braided together with the two suture rails and extended proximal from the cap 102. Alternatively, as shown in Figure 2B, the suture 106 may loop back and braid itself to increase the size (e.g., width) of the portion of the suture 106 that interlocks or engages with the lumen 110, and a single rail may extend proximal along the delivery device 30. In yet another case, two sutures 106 can pass through or cooperate with an elongated member 107 (such as another suture portion or a braided tubular member) shown by dashed lines in Figures 2A and 2B, braided onto the elongated member 107, and increase the size of the portion of the suture 106 that is placed inside the cap 102 and / or lumen 110. Optionally, one or more elongated members 107 can be inserted into one or more sutures 106 to enlarge their dimensions.

[0057] The cap 102 may initially be positioned at the proximal end of the suture 106, that is, the end of the suture 106 that does not have a diameter greater than the diameter of the lumen 110 of the cap 102. In some embodiments, the suture 106 has a diameter that varies along its longitudinal axis. As the cap 102 is advanced distally along the suture 106 toward the lateral vessel surface 20 at the access site 18, the thicker suture portion 112 causes an interlocking fit that can lock the cap 102 in place, achieving immediate (or substantially immediate) dry closure.

[0058] The tightening fit eliminates the need to use knots to maintain the dry closure formed when the closure device 100 is embedded and tightened. The use of knots can pose a significant risk to the patient if the set tension of the suture is excessively tightened. The suture is subjected to stress by the patient walking or coughing, which can cause excessive tension on the suture and lead to breakage. The disclosed tightening fit is advantageous because it is knotless and the flexibility of the cap can adapt to the forces applied to the suture.

[0059] In addition to the interlocking fit between the cap 102 and the thick suture portion 112, or alternatively, the cap 102 may optionally include an adhesive applied to the sides of the cap that contact the vascular surface 20. For example, as shown in Figures 3C-3D, the cap 102 may include an adhesive layer 128 that binds to extravascular tissue as the cap 102 advances toward the anchor 108. The adhesive for the adhesive layer 128 can be a non-moving adhesive in that it does not flow through the puncture site or access site 18 when the extravascular tissue is sandwiched between the cap 102 and the anchor 108. Examples of such adhesives include non-expanding adhesives such as non-expanding polyethylene glycol (PEG), adhesive proteins such as barnacle adhesives, cross-linked gelatin, (non-biological) cyanoacrylate, polyurethane adhesives, other adhesives or adhesives, and / or combinations and modifications thereof. More generally, the adhesive may use a cross-linking mechanism that relies on chemical conjugation between reactive groups, free radical polymerization, redox reactions, and / or biological or biochemical coupling.

[0060] Figures 4 to 6B show examples of deployed closure devices 100 that include a second extravascular component as a fluid-blocking component or sealant 104. The sealant 104 may be an active biological material such as polyethylene glycol (PEG), fibrin sealant, a copolymer of glucosamine and N-acetylglucosamine, dextran (a complex branched glucan (a polysaccharide derived from glucose condensation)), polypeptide adhesive structures, adhesive proteins containing L-3,4-dihydroxyphenylalanine (L-DOPA), adhesive proteins containing DOPA and phosphoserine, collagen, polyacrylic acid, polyacrylic acid crosslinked with allyl sucrose or allyl pentaerythritol, polyacrylic acid, crosslinked with divinyl glycol, an acrylic resin polymer composed of methyl-2-cyanoacrylate units, or optionally incorporated into a molded flexible substrate. The sealant material can be activated by a fluid present in the patient's tissue pathway, such as blood or other body fluids, and can be protectively housed inside either the sheath or actuator or the chamber of the delivery device until placed directly on top of the cap 102.

[0061] Once advanced to the desired position, the fluid-blocking component or sealant 104 may be exposed to blood or other bodily fluids. For example, by removing the sealant 104 from its sheath and positioning it in direct contact with the tissue, a reaction between the sealant 104 and the blood and / or other present fluids is enabled. This reaction can cause the sealant 104 to expand, absorbing the blood and / or other fluids and bonding to the surrounding tissue and cap 102. The sealant 104 can act as an adhesive, helping to "lock" the cap 102 into place on the blood vessel 10. The sealant 104 also actively coagulates the entire access passage 22 due to the reaction with blood and / or other bodily fluids. The chemical composition, quantity, carrier matrix, and / or dimensions of the sealant 104 may be specifically selected to provide one or more of the following functions: the ability to lock the sealant 104 in place (e.g., relative to the cap 102), the ability to lock the cap 102 in place, the ability to provide a fast-acting, leak-free dry close, and the ability to reduce seepage from the tissue pathway.

[0062] For example, the sealant 104 can form a plug having a length of approximately 1 mm to approximately 10 mm, for example, 4, 5, 6, or 8 mm, or a length established by any two of the aforementioned values. The sealant 104 may be trimmed to the patient's length together with the suture 106 after deployment, if necessary. Alternatively, the sealant 104 may extend along the entire length of the tissue pathway 22 and be trimmed to fit the patient. If the sealant 104 is formed in matrix form, the matrix may have an area of ​​approximately 0.012 square inches to approximately 0.12 square inches, approximately 0.12 square inches to 0.6 square inches, or approximately 0.6 to 1.0 square inches. The matrix material may be thin and flexible so that it can be wrapped around the suture 106 in the delivery system to adhere to the inside of the tube for delivery to the implant site. This yields volumes of fluid-blocking components or sealants 104 (including optionally a matrix containing sealant such as PEG or other biocompatible material) of approximately 0.004 to approximately 0.040 cubic inches, approximately 0.040 to approximately 0.100 cubic inches, or approximately 0.100 to approximately 0.400 cubic inches.

[0063] The sealant 104 can be deployed so as to be positioned on or covering the suture 106. Thus, the sealant 104 can be deployed as a fluid composition without a carrier matrix, or it can be formed as part of or together with a carrier matrix. For example, the sealant 104 can be positioned in a generally cylindrical manner around the suture 106, bonded to the suture 106 itself, bonded to the cap 102, and / or a combination or modification thereof. Because the sealant 104 is positioned and deployed proximal to the cap 102, the sealant 104 can actively solidify around, on, and through the access passage 22, and optionally, actively solidify the entire access passage 22 down to the surface of the skin 16.

[0064] As shown in Figures 4 to 6B, the sealant 104 may have a conical shape when deployed. In other embodiments, the sealant 104 may have a continuous or uniform thickness along its length. The cap 102 may be larger than the opening or access site 18 so that the cap 102 can displace tissue at the access site 18. The sealant 104 may also fill the space created by the displaced tissue. The sealant 104 may be formed of a material having the property of swelling from its original size upon contact with blood and / or other bodily fluids, and being able to effectively cover and reinforce the seal formed by the cap 102. The sealant 104 may swell from its original size to a range established by about 1 to 6 times, about 2 to 4 times, or about 2.5 to 3.5 times its original size, or any two of the aforementioned values. Optionally, expanding the access passage 22 as close as possible to the skin 16 (i.e., expanding proximal) may be advantageous in mitigating or reducing any bleeding. Such dilation can occur very quickly (for example, almost instantaneously) after contact with the dilating fluid, for example, in about 15 seconds to 5 minutes, 30 seconds to 4 minutes, 1 minute to 3 minutes, 15 seconds to 1 minute, or 15 seconds to 45 seconds.

[0065] If the sealant 104 has a predetermined conical or tapered shape, it is formed as an independent sealant element having a through hole at the center or elsewhere, thereby allowing the sealant 104 to be passed through the suture 106. More generally, the suture 106 may be passed through the sealant 104 and / or at one or more points around the sealant. The sealant component may be a form matrix or other formed substrate into which a biocompatible material is injected and then formed into a desired shape such as a PEG. The sealant 104 may be a combination of two or more components that can be loaded into any of the actuators 50, 60, or 70. The handle or grip portion of the actuators 50, 60, or 70 is then pressed down to actuate the two or more components simultaneously, exposing the sealant 104 to blood and / or other bodily fluids. The two or more components may include one or more fluid components with or without a matrix having a predetermined shape or a matrix biased to a particular shape.

[0066] In other embodiments, the sealant 104 and the cap 102 can be deployed together as if they were a single component. The cap 102 can cover the access portion 18, and the sealant 104 can be activated on and over the cap 102 to seal the access passage 22.

[0067] In other embodiments, as schematically shown in Figure 1F (for simplicity of explanation, actuator 50, anchor 108, and cap 102 are omitted), the sealant 104 may be stored in a chamber 103 at the proximal end of the delivery system 30. The sealant 104 can be stored in the form of a generally flat or flat sheet and, if necessary, can be biased into the form of a generally flat or flat sheet. The sealant 104 is delivered to the cap 102 through a funnel 105 or other proximal deployment port, and the planar or flat sheet form can be curled, folded, or otherwise deformed to advance toward the cap 102.

[0068] In one configuration, actuator 70 can be used to advance sealant 104 from the chamber (arrow A) along actuator 60 to deploy sealant 104 from within actuator 60. For example, actuator 70 advances distally when actuator 60 is partially pulled proximal to engagement with cap 102 (arrow B). Such partial proximal withdrawal is typically performed via another actuator or structure, or a combination or modification thereof, after tissue has been trapped between cap 102 and anchor 108. This movement exposes sealant 104 to blood and / or other fluids, causing the sealant 104 to react and expand.

[0069] Generally, when introducing a coagulant or sealant, there is a risk of introducing embolic material into the blood vessel 10, which can cause a blood clot and thereby endanger the limb. Emergency surgery may be required to remove the material. This risk can be mitigated by the configuration of the closure device 100, specifically by first covering the access site 18 with the use of a cap 102, thereby preventing the extravascular sealant 104 from entering the blood vessel 10.

[0070] The thin cap component 102 is unique in that it contains a stable, biodegradable, absorbable, or reabsorbable material (i.e., a material that does not swell or actively bond to tissue), and is combined with an active sealant 104 material on top of it, forming an integrated extravascular implant, which distinguishes this design from other closure devices. Specifically, the disclosed design prevents extravascular or other unwanted components from migrating into the punctured vessel, thereby sealing the vessel and preventing infection.

[0071] Next, looking at Figures 7A to 7H, the closure device 100 may include an intravascular anchor 108, such as a graft-type anchor. Figures 7C to 7D show one embodiment of the anchor 108, where Figure 7C shows the lumen-facing side 117 of the anchor 108, and Figure 7D shows the intima-facing side 127 of the anchor 108. Similarly, Figures 7E to 7F show the lumen-facing side 117 and the intima-facing side 127 of the anchor 108, respectively. Figures 7G to 7H show the closure device 100 substantially assembled but not yet implanted.

[0072] The anchor 108 may include one or more of the following elements: 1) a large surface area of ​​an elongated shape, also called an elongated member 117; 2) a central keel 120 that can provide a suture attachment site and overall rigidity; 3) a flexible portion or membrane 122 that can conform to the vessel wall; 4) a hole, eyelet, or other structure 118 that can provide suture attachment to the anchor 108 and the extravascular component (e.g., cap 102) of the closure device 100; 5) a flexible edge 126 of the flexible portion or membrane 122 that can allow storage in a cylindrical state to enable delivery of the closure device 100 to the vessel 10. The anchor 108 may be formed from a plurality of subcomponents joined together. Alternatively, the anchor 108 may be formed as a monolithic component, with one or more of the elements formed as a single component by casting or machining of a base material.

[0073] The anchor 108 may be formed from a bioabsorbable material while having flexibility that allows it to be wound into a smaller profile inside a delivery sheath such as the delivery sheath 40. This ensures a larger sealing surface when released from the delivery sheath 40. The anchor 108 is attached to the suture 106 using a pattern of holes or eyelets 118 that can distribute the tensile load more widely across the width of the anchor 108, thereby preventing breakage due to high force concentration during device deployment.

[0074] The anchor 108 may have a curved contour to better conform to the curvature of the vessel wall. The anchor 108 may also have an enlarged central portion or a keel 120. The keel 120 can help reinforce the seal formed over the access site 18 by the closure device 100 and can help provide one or more suture attachment points. The rigidity of the keel 120 can provide mechanical leverage for advancing and ejecting the anchor 108 from the delivery sheath 40, and a robust position. The keel 120 may have a thickness of about 0.5 mm to about 0.8 mm, about 0.6 mm to about 0.9 mm, about 0.7 mm to about 1.0 mm, or other thicknesses to provide the desired suture attachment points.

[0075] Surrounding the keel 120 is an elongated member 117. The material forming the elongated member 117 may be the same as that of the keel 120, such as a bioabsorbable material, and material a has a durometer in the range of approximately 50 Shore A to approximately 100 Shore A, approximately 80 Shore A to approximately 90 Shore A, a durometer selected based on the closure position, and / or a durometer within a range established by any two of the aforementioned values. The elongated member 117 may have a thinner, more flexible portion relative to the keel 120, which can conform to the curved vessel wall 14. The flexibility of the thinner portion also allows the anchor 108 to conform to any specific calcification accumulation within the vessel 10, which typically occurs after puncture or wounding. The elongated member 117 may have an elliptical or egg shape with a short axis dimension of approximately 2.0 mm to 10.0 mm, approximately 3.0 mm to 5.0 mm, or approximately 4 mm, and the long axis may range from approximately 4.0 mm to 12.0 mm, approximately 6.0 mm to 8.0 mm, or approximately 6.0 mm. The configuration of the anchor 108, more generally the closure device or implant 100, may be modified based on the specific opening in the blood vessel to be closed, and as a result, it is understood that the dimensions may be adjusted to generally correspond to openings of 5F to 8F or openings larger than 8F or smaller than 5F.

[0076] The projection or keel 120 can extend along the central axis of the elongated member 117 over its entire length and may be given rigidity to which a suture 106 can be attached. The suture 106 may be attached via a suture attachment point or hole 118 of the keel 120. One or more holes 118 may provide points for passing the suture 106 to attach the anchor 108 to the cap 102 and sealant 104. The holes 118 may be spaced evenly or unevenly along the length of the keel 120. The spacing of the holes 118 may help distribute the tensile load applied over the desired length of the anchor 108, such as all or part of the length of the anchor 108. The spacing may also prevent the anchor 108 from breaking, tearing, or ripping under load. In the embodiment, as shown in Figures 7A to 7H, the free distal end of the suture 106 can be first passed through each of the outermost holes 118a, then both through the intermediate holes 118b, and then pulled upward from the access or puncture site 18. The free distal end can also be braided back onto the suture 106 to form a thicker suture portion 112 (see Figure 2B).

[0077] The anchor 108 can be formed by injection molding, casting, punching, machining, and combinations or modifications thereof. Depending on the desired strength, stiffness, and absorbency, the anchor 108 may contain one or more bioabsorbable materials, bioabsorbable polymers, or bioabsorbable elastomers. The structure of the anchor 108 may be formed from a homogeneous material mixture whose flexibility is adjusted by a combination of shape and material formulation. A secondary adhesive may be attached to or bonded to the inner lining-facing surface 127 of the anchor 108 to increase adhesive strength and improve sealing performance against the inside of the vascular wall. The anchor 108 provides a safe way for the sealant 104 to interact directly with vascular tissue without the risk of the sealant 104 embolizing into the vascular lumen, since the sealant 104 is attached to the anchor 108. Examples of bioabsorbable materials into which any of the described components may be formed include, but are not limited to, polyglycolic acid (PGA), polylactide (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), poly-DL-lactic acid (PDLLA), polytrimethylene carbonate (PTMC), polyparadioxanone (PPDO), combinations thereof, and / or modifications thereof. An example of bioabsorbable triblock copolymers that may be used with any such component is described in U.S. Provisional Patent Application No. 63 / 505,920, filed May 31, 2023, entitled "ABA TRI-BLOCK COPOLYMER AND BIORESORBABLE IMPLANTS MADE THEREWITH," which is incorporated herein by reference in its entirety. More generally, the material forming the anchor 108 or other components may have a durometer in the range of about 50 Shore A to about 100 Shore A, or about 80 Shore A to about 90 Shore A.When anchor 108 is temporarily deployed, the anchor can be formed from non-bioabsorbable materials such as polyvinyl chloride (PVC), polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), nylon, silicone, urethane, thermoplastic elastomers such as polyether block amide (PEBAX), polyethylene terephthalate (PET), fluoropolymers, or other biocompatible materials, combinations thereof, and / or modifications thereof.

[0078] The anchor 108 can have a mass in the range of approximately 4 mg to 8 mg (for a 4 mm x 6 mm ellipse), approximately 8 mg to approximately 16 mg (for a 5 mm x 7 mm ellipse), or approximately 15 mg to 30 mg (for an 8 x 10 mm ellipse). The lower the overall mass, the less force is required to hold the anchor 108 in place through frictional engagement between the cap 102 and the suture 106. This results in a smaller overall system, which in turn makes it easier to position the anchor 108 within the patient's body and reduces the overall impact on the patient's recovery process.

[0079] Figures 8A to 8B show another exemplary embodiment of the intravascular anchor 108. In Figures 8A to 8B, the anchor 108 includes a side facing the lumen 129 (Figure 8A) and a side facing the intima 127 (Figure 8B). Similar to the anchor 108 in Figures 7A to 7H, the anchor 108 may include an elongated body 117 having a flexible member or membrane 122, and a keel 120 positioned along the central axis of the elongated body 117 and extending along the length of the elongated body 117. The keel 120 can provide adequate rigidity for attaching the intravascular anchor 108 to an extravascular element (e.g., cap 102) of the closure device 100 by a suture 106.

[0080] The keel 120 can be raised against the lumen-facing side 129 of the anchor 108, which can help maintain the anchor 108 on the vessel wall 114. The intimal side 127 of the anchor 108 may include a number of ribs 124 that radiate outward from the keel 120 and extend to a raised rim 126 that forms around the elongated body 117. The ribs 124 and the raised rim 126 provide encapsulation of localized plaque on the vessel wall 114. The stiffness of the raised rim 126 of the anchor 108 can be correlated with the stiffness and / or pattern, number, and / or thickness of the ribs 124 radiating from the keel 120. The width and taper of the ribs 124 can be modified to affect the compliance or stiffness of the rim 126 of the anchor 108.

[0081] Figures 9A and 9B show another embodiment of the anchor 208. Figure 9A shows the surface 229 facing the lumen, and Figure 9B shows the side 227 facing the lumen. The anchor 208 may include an elongated body 217 having a flexible member or membrane 222, and a raised keel 220 located centrally along the length of the elongated body 217. The elongated shape of the anchor 208 is modified to maximize the surface area of ​​the anchor 208. In this depiction, the number of ribs 224 is reduced, which can increase the compliance of the anchor 208 with the vessel wall 14. The anchor 208 may also have a raised edge 226 extending around the elongated body 217. One or more holes 218a, 218b in the keel 218 provide points through which sutures 106 for attaching the anchor 20 to the extravascular component of the closure device 100 can be passed.

[0082] Figures 10A and 10B show another embodiment of the anchor 308. Figure 10A shows the side facing the lumen 329, and Figure 10B shows the intimal side 327. The anchor 308 may include an elongated body 317 having a flexible membrane, and a raised keel 320 located on the central axis of the elongated body 317 and extending along the length of the central axis of the elongated body 317. The keel 320 may include one or more holes 318 through which a suture 106 can be passed. In this embodiment, the ribs (124, 224) are omitted to allow for maximum flexibility of the anchor 308. The raised edge 326 extending around the intimal side of the anchor 308 can provide the anchor 308 with the structural integrity necessary to maintain the shape of the anchor 308 when placed on the vessel wall 14.

[0083] Method of inserting occluding devices Here, we refer to Figure 11A, which shows the steps of the process for deploying anchor 108. As shown in Figure 11A, the delivery sheath 40 can be positioned so that the distal end 42A of the outer housing 42 moves through an access channel 22 formed in the tissue 24 to approach the puncture or access site 18 formed in the lumen 12 and the vessel wall 14. The distal end 42A of the delivery sheath 40 advances into the lumen 12 until pulsating blood is visually observed from a blood outlet port 49 (see Figure 1A) located proximal to the bleedback or blood marker lumen formed in the wall of the delivery sheath 40. Alternatively, the blood outlet port 49 may be formed by a separate bleedback tube formed either inside or outside the delivery sheath 40. A blood inlet port 47 (see Figure 1A) is in fluid communication with the blood outlet port 49 and is positioned toward the distal end 42A of the delivery sheath 40.

[0084] When blood flow is observed, the actuator 50 can be operated as described above to push the anchor 108 out of the distal end 42A of the outer housing 42. Alternatively, the actuator 60 can push the cap 102, which then pushes the anchor 108 distally to the outer housing 42 (as shown in Figure 11B), thereby deploying the anchor 108 from the distal end 42A of the outer housing 42. In such cases, the actuator 50 can be optionally omitted.

[0085] In one embodiment, when deployed, the anchor 108 can rotate or be configured to rotate from a first orientation to a second orientation. In the first orientation, the long axis 136 of the anchor 108 is at a small angle to or nearly parallel with the outer housing 42 and nearly perpendicular to the vessel wall 14, as shown in Figure 11A. In the second orientation, the long axis 136 of the anchor 108 is nearly parallel to the lumen 12 and at a larger angle to or nearly perpendicular to the delivery sheath 40, as shown in Figure 11B.

[0086] In particular, as shown in Figure 11B, when the anchor 108 is pushed from the distal end 42A of the outer housing 42, the anchor 108 can be rotated or made to rotate in a second direction. Such rotation may be caused by the tension that the suture element 106 applies or is applied to the anchor 108 through the central or intermediate hole 118b (see Figures 7C-7F). The anchor 108 can then be pulled proximal to fix it to the inner surface 14A of the vessel wall 14, as shown by the dashed line in Figure 11B. Although the suture 106 is shown in Figures 11A and 11B to extend proximal within the lumen of the actuator 50, if the actuator is non-coaxial, as shown in Figures 15 and 16, the suture 106 does not need to extend within the lumen of the actuator 50, and there is no need to provide a lumen in the actuator 50. The suture 106 can extend into any lumen of the delivery system 30, as schematically shown by the solid and dashed lines of the suture 106 in Figure 1F.

[0087] With the anchor 108 deployed and positioned against the inner surface of the vessel wall 14 and the delivery sheath 40 partially retracted into the access passage 22, the actuator 60 can deploy the cap 102 over the puncture site 18 between the vessel wall 14 and the tissue 24 through which the access passage 22 is formed. In particular, as shown in Figure 11C, the actuator 60 can be advanced distally, the delivery sheath 40 can be drawn proximal, and / or using some combination of such movements, the cap 102 can be moved distally from the outer housing 42 and brought into contact with the proximal or outer surface 14B of the vessel wall 14 adjacent to the puncture 18. The vessel wall 14 is positioned between (i.e., sandwiched between) the anchor 108 and the cap 102, and the cap 102 is positioned on the outer surface of the access site 18 and "locked" in place as a result of the tight fit produced by the thick suture portion 112. Therefore, the cap 102 can be positioned to reduce or stop the outflow of fluid from the conduit 22 by covering the puncture site 18 and / or blocking the conduit 22.

[0088] To confirm that blood flow is reduced or stopped, the operator can observe the blood flow from the blood outlet port 49 (Figure 1A) to determine the degree of hemostasis. Persistent blood flow from the blood outlet port 49 (Figure 1A) indicates that hemostasis has not been adequately achieved and may indicate to the operator that they should continue to reposition the cap 102 relative to the tissue to improve hemostasis. Alternatively, blood flow can also be observed by maintaining one or more valves or seals 55, 65, 75 of the actuators 50, 60, 70, or one or more valves or seals 45 of the delivery sheath 40 in the open position, allowing blood to flow from one or more of the actuators 50, 60, 70, or the end of the delivery sheath 40. In a particular configuration, actuator 60 may include an expansion portion that maintains the valve or seal 45 of the delivery sheath 40 in the open position so that blood can exit from the end of the lumen when hemostasis has not been achieved. As with blood flow from the blood outlet port 49 (Figure 1A), persistent blood flow from one or more of the actuators 50, 60, or 70 or from the end of the delivery sheath 40 indicates that hemostasis has not been adequately achieved and may indicate to the operator that the cap 102 should continue to be repositioned relative to the tissue to adequately achieve hemostasis. By moving the expanded portion of actuator 60 away from or back through one or more valves or seals, the valves or seals (e.g., 45, 55, 65, 75) can be closed after the cap 102 has advanced toward anchor 108, thereby achieving hemostasis and reducing blood flow.

[0089] Returning to Figure 11C, advancing the cap 102 toward the anchor 108 stabilizes the tissue 24 surrounding the puncture site 18, facilitating the closure of the puncture site 18. In particular, once the anchor 108 and cap 102 are deployed, the actuator 60 can apply tension to the suture 106 to fix the anchor 108 against the inner surface 14A of the vessel wall 14 while the cap 102 is advanced distally toward the outer surface 14B of the vessel wall. In one example, a suture lock (not shown) can be used to help maintain tension on the suture element 106. The combined forces exerted on the vessel wall 14 by the anchor 108 and cap 102 apply a compressive force to the tissue 24 near the puncture site 18, i.e., pinching the tissue 24 between the anchor 108 and cap 102. The tension applied to suture 106 is approximately 1 pound-force (lbf) to approximately 16 lbf, approximately 1 lbf to approximately 8 lbf, approximately 2 lbf to approximately 6 lbf, or approximately 2.5 lbf.

[0090] Since the anchor 108 is formed from an elastic, flexible material and the cap 102 can be formed from an elastomer material (e.g., a bioabsorbable polymer, bioabsorbable elastomer, etc.), the material properties allow the anchor 108 and cap 102 to absorb applied forces without breaking, buckling, bending, tearing, or otherwise failing. The suture 106 may also include a visual indicator to show the user when the cap 102 has reached the appropriate depth, i.e., when the cap 102 has reached the blood vessel wall 14. However, if excessive force is applied, this may cause the suture 106 to break, but since there is no knot or other stationary element to hold the cap 102 in place, the cap 102 and anchor 108 are not subjected to excessive tension. This feature means that the practitioner does not need to worry about the degree of force being applied.

[0091] The placement of the cap 102 also pushes the tissue 24 laterally relative to the axis of the conduit 22. This increases the space for the subsequent injection of sealant 104 and increases the surface area of ​​the vessel wall 14 and the cap 102 that can receive the sealant 104. In doing so, the closure efficiency of the puncture site 18 is improved.

[0092] Optionally, in a configuration where actuator 60 can deploy both anchor 108 and cap 102, actuator 60 can maintain continuous contact with cap 102 throughout the deployment process. Such a configuration allows for the deployment of anchor 108 and / or cap 102 by advancing actuator 60 in a single direction. By using the unidirectional movement of actuator 60 to facilitate the deployment of anchor 108 and cap 102 and utilizing a single actuator, the delivery system can quickly and easily deploy anchor 108 and / or cap 102 and sealant 104.

[0093] In an optional configuration, the actuator 60 can deploy the cap 102 and advance the sealant 104 toward the cap 102. As the actuator 60 moves distally, the sealant 104 moves toward the cap 102, and as the actuator 60 subsequently moves proximal, the sealant 104 is released from within the actuator 60. In this configuration, the actuator 70 is optionally omitted.

[0094] Returning to the illustrated configuration, once the cap 102 is in position, the sealant 104 can be deployed from the delivery sheath 40 by proximal withdrawal of the delivery sheath 40 and optionally the actuator 60, and distal advancement of the actuator 70. The sealant 104 can be deployed by any combination of one or more movements that advance or release the sealant 104 from the outer housing 42 and bring it into contact with the vessel wall 14 and the outer surface 14B of the cap 102. As the delivery sheath 40 is moved proximal or retracted, and / or the actuator 60 is moved proximal or retracted, the sealant 104 is exposed to body fluids and activated, as shown in Figure 11D. The activated sealant 104 can act as an adhesive to fix the cap 102 in place and enhance the hemostatic effect of the cap 102 by solidifying the access passage 22 and preventing leakage. To reduce potential bleeding, it may be advantageous to bring the sealant 104 as close to the skin surface as possible.

[0095] During the approximately 15-5 minutes, 30-4 minutes, 1-3 minutes, 15-1 minute, and 15-45 seconds while the sealant is activated, the practitioner can observe for any blood flow from the blood outlet port 49 (Figure 1A) and determine the degree of hemostasis. Based on the force applied to the cap 102 to seal the puncture site 18, the cap 102 can seal or substantially seal the puncture site 18, and as a result, the sealant 104 is used to limit tissue exudation around the cap 102 and from the tissue pathway 22. The sealant 104 also secondarily secures the cap 102 to the suture 106 and the puncture site 18. In other words, primary closure of the puncture site 18 can be achieved through the seal provided by the anchor and cap, while the sealant 104 provides secondary sealing and / or stopping of exudation from the tube.

[0096] However, if blood flow continues from the blood outlet port 49 (Figure 1A), the practitioner can further manipulate the actuator and anchor 108 to tighten the cap 102 over the suture 106, or optionally wait for the sealant 104 to fully actuate and reduce or eliminate the blood flow to the practitioner's preference. More generally, the combination of cap 102 and sealant 104 allows dry closure to be achieved within seconds of activating the sealant 104. The practitioner can also compress the area with gauze to drain the blood and then confirm hemostasis. While exemplary times to hemostasis are provided, the time to hemostasis may be influenced by or correlate with the anticoagulant administered to the patient. The combination of cap 102 and proximal sealant 104 may allow hemostasis to be achieved more quickly than with the use of sealant 104 alone.

[0097] Whether complete or substantially complete hemostasis results from the cap 102 or from the combination of the cap 102 and the sealant 104, after hemostasis is achieved, the suture 106 can be trimmed by pressing down on the skin 16 while holding down the suture 106 and using a suture trimming device (not shown), such as a scalpel or other suture trimming device, to trim the suture 106 as close to the skin as possible. Once the skin is released, the suture 106 is located considerably below the surface of the skin, as shown in Figure 11D.

[0098] While we have referred to anchors 108 (208, 308) that remain in the blood vessel and are broken down, absorbed, or reabsorbed by the patient's body, it will be understood that in other configurations, the anchor 108 may be deployed and then removed once the puncture site 18 is adequately closed. In such cases, the anchor 108 is deployed "temporarily," and other parts of the closure element 100, such as the cap 102 with an adhesive layer 128 (see Figures 3C and 3D) and the sealant 104 described herein, can be used to close the access site after the removal of the anchor 108. The cap 102 with the adhesive layer 128 may or may not cooperate with the suture 106 and optionally lock into the suture 106 attached to the anchor 108. The cap 102 is held in place against the blood vessel wall 14 by the adhesive layer 128 and optionally the sealant 104, the sealant 104 reducing or eliminating leakage from the tissue pathway 22. The delivery of the temporary anchor 108, cap 102, and sealant 104 in this alternative configuration corresponds to the removal of the anchor 108 by pulling the suture 106 or another anchor actuator proximal to remove the anchor 108, and can be carried out using the delivery systems and apparatus described herein. The anchor 108 can optionally pass through the lumen 110 of the cap 102, and the body of the cap 102 has sufficient elasticity or stretchability to return to a closed state to close the puncture site 18. Alternatively, the anchor 108 can be pulled past the side of the cap 102, in which case the cap 102 has sufficient elasticity to temporarily deform and return to a state that seals against the outer surface 14B of the vessel wall 14.

[0099] Vascular occlusion delivery system with handle assembly Figures 12 to 23B illustrate a delivery system and method for inserting the type of occlusal device described herein. The delivery system 430 may include a handle assembly 400 and a delivery sheath 440. The handle assembly 400 may be configured to be selectively attached to the delivery sheath 440 (similar to the delivery sheath 40 in Figures 1A to 1F). Once attached to the delivery sheath 440, the handle assembly 400 can be used to insert an occlusal device, such as an occlusal device 100.

[0100] As shown in Figures 13A to 13E, the handle assembly 400 may include a handle body 402 having a proximal end 404 and a distal end 406, one or more actuators (such as a slider 450), and an elongated opening 408 configured to provide a trajectory for the slider 450. The slider 450 may be configured to slide along the elongated opening 408 when engaged by the operator and to be selectively locked in place by a locking assembly 425. The closure device 100 can be deployed by sliding or moving the slider 450 along the elongated opening 408. The handle assembly 400 may also include a second slide (e.g., a cap slide) 460 configured in a second elongated opening 412 of the handle body 402. The anchor 108 can be deployed by the action of the slider 450, and then the cap 102 can be deployed by the action of the cap slide 460.

[0101] In other embodiments, the handle assembly 400 may have only one actuator element, such as a slider 450, which, when actuated, can then deploy the anchor 108 and cap 102 without requiring a second slide. Any number of slides or other actuators may be provided.

[0102] In some embodiments, such as those shown in the drawings, the handle body 402 may include one or more textured portions 414 to improve the practitioner's grip on the handle assembly 400. The handle assembly 400 may further include a connecting member 416 located at the distal end 406 of the handle body 402. The connecting member 416 may be configured to be selectively attached to and detachable from the delivery sheath 440. The connecting member 416 may also be configured to attach to the sheath hub 418 of the delivery sheath 440 (see Figures 18A-18B). As shown in Figures 13A-13F, the connecting member 416 consists of a pair of locking members 420, each having a hooked end 422. The locking members 420 may be configured to be selectively attached to the sheath hub 418 of the delivery sheath 440. The sheath hub 418 attaches the handle assembly 400 to the delivery sheath 440 to form a delivery system 430.

[0103] As shown in Figure 13B, the handle assembly 400 may also include a release button 424 that can release the suture 106 from the system 430 when the closure device 100 is positioned in the desired location. Activating the release button 424 releases (e.g., detaches or disengages) the delivery system 430 from the embedded closure device 100. The release button 424 may include an engaging element such as a release button fin 419 (see Figure 14A). The release button fin 419 is configured to fit into a release groove 407 and slide along the length of the groove 407 to release the suture 106 of the closure device 100 from the handle assembly 400. In other embodiments, the function of the release button 424 may be incorporated into one or more actuator elements, such as a slider 450 and / or a cap slide 460.

[0104] Figure 13E shows a cross-sectional view of the handle assembly 400. As shown in Figures 13A to 13E, the slider 450 may include a first portion 450a and a second portion 450b. As most clearly shown in Figure 13E, portions 450a and 450b may be selectively connected to each other by linking their ends 466a and 466b. The proximal lock assembly 421 can engage with the slider 450 to "lock" the slider 450 at the proximal end 404 of the handle assembly 400. For example, the proximal lock assembly 421 and a complementary structure on portion 450a of the slider 450 may engage to restrict the movement of the slider 450. When the proximal lock assembly 421 is pressed down, the complementary structure 421a is disengaged or separated from the complementary structure 451a, allowing the slider 450 to move distally. The portions 450a, 450b, their interlock ends 466a, 466b, and the proximal lock assembly 421 can be made of an elastic material such as flexible plastic to allow the components to bend when pressed down by the practitioner. For example, the practitioner can press down the proximal lock assembly 421 to release the slider 450 and slide the slider 450 along the elongated groove 408. The proximal lock assembly 421 can be formed together with the handle body 402, such as having a living hinge connection with the handle body 402, or it can be a separation mechanism connected to or attached to the handle body 402.

[0105] Figures 14A and 14C are exploded perspective views of the handle assembly 400. The handle body 402 may have a first side 402a and a second side 402b, which, when assembled together, form the lumen 428 of the handle body 402. The first side 402a and the second side 402b may be assembled together to form the handle body 402 by using fasteners such as screws 409 inserted into corresponding holes 411. Of course, or alternatively, other mounting mechanisms may be used. The handle body 402 may be configured to house an implant assembly 426. The implant assembly 426 (described in more detail below) includes a tamper tube 442, a carriage 438, a stopper 444, and a closure device 100.

[0106] The handle body 402 can also house a chamber assembly 427 having a chamber body 427a and a chamber cap 427b, as shown in Figures 13F and 14B, and the chamber assembly 427 may be located at the distal end 406 of the handle body 402. Although the chamber assembly 427 is shown as two parts, it will be understood that the chamber assembly 427 can utilize fewer or more parts to form an assembly that can provide the functions described herein. The chamber assembly 427 can also be formed separately from the handle body 402, as shown, but in other embodiments, the chamber assembly 427 may be formed integrally within the handle body 402. The chamber assembly 427, in particular the chamber body 427a, can be aligned with the lumen 428 and the distal opening 436 to form a channel 437 through which the implant assembly 426 can deploy the closure device 100.

[0107] The chamber assembly 427 may include a chamber body 427a having a nozzle 429 and a nozzle ring 439. The nozzle 429 and ring 439 can be coupled with a delivery sheath 440 and molded to form a liquid-tight seal between the handle assembly 400 and the delivery sheath 440. The closure device 100 of the implant assembly 426 may be deployed from the lumen 428 through the channel 437 and then from the chamber body 427a, etc., through the nozzle 429 of the chamber assembly 427 into the delivery sheath 440. In some embodiments, the chamber assembly 427 may include a valve 431. The valve 431 may be a one-way valve that prevents fluid from entering the lumen 428 of the handle body 402. The valve 431 may be fitted into a valve notch 472 at the proximal end of the chamber body 427a. The chamber body 427a may also include a pedestal 433.

[0108] The chamber assembly 427 includes a chamber cap 427b, as shown in Figure 14A. The chamber cap 427b may be located on top of the chamber 427 at the distal end 406 of the handle body 402. The chamber cap 427b may include one or more positioning elements 435 that can help form a channel 437 and hold the chamber cap 427b in the correct orientation and position within the handle body 402. When the chamber body 427a and the chamber cap 427b are connected or joined to each other, they form a cavity 449 for receiving the closure device 100, as shown in Figure 13F. The cavity 449 communicates with and forms part of the lumen 428.

[0109] The implant assembly 426 is housed within the handle body 402. The implant assembly 426 houses the closure device 100 and other elements required to position the closure device 100. The implant assembly 426 may be configured to be located within the lumen 428 of the handle body 402. The lumen 428 may extend along the longitudinal axis 432 from the proximal opening 434 of the proximal end 404 and terminate at the distal opening 436 of the distal end 406 of the handle body 402. The implant assembly 426 may be located within the lumen 428 so as to be mechanically compatible with the elements of the handle body (i.e., the slider 450 and the cap slide 460).

[0110] The implant assembly 426 (shown in detail in Figures 14A, 14C-14F, 15 and 16) includes a closure device such as the closure device 100, a tamper tube 442, a carriage 438, and a stopper 444. The carriage 438 may have a body 446 having a slider 450 (located outside the handle body 402) and a projection 448 that provides a mechanical connection between the body 446 and the tamper tube 442 located in the lumen 428 of the handle body 402. The carriage 438 may also include a groove 447a configured to receive nesting elements of the implant assembly 426 (e.g., the tamper tube 442, the closure device 100, the tube 454, and the push wire 452). The carriage 438 may also include a suture groove 447b, which allows for mechanical communication between the implant assembly 426 and the handle body 402, facilitating the release of the suture 106 from the implant assembly 426 and the handle body 402.

[0111] The stopper 444 may include a stopper elbow 466 configured to engage with the internal locking mechanism 423. When the stopper 444 is moved distally (i.e., toward the distal end 406 of the handle body 402), the stopper 444 passes the internal locking assembly 423. After passing the internal locking assembly 423, the stopper elbow 466 can engage with the internal locking assembly 423, preventing the stopper 444 from moving proximal. The stopper 444 can prevent closing device elements, such as the fluid shutoff component 104, from flowing back into the handle assembly 400. The internal locking mechanism 423 may be formed together with the handle body 402, such as having a living hinge connection with the handle body 402, or it may be a separate mechanism connected to or attached to the handle body 402.

[0112] Figures 14D and 14E are detail views of the carriage 438 of the implant assembly 426. As described above, the carriage 438 may include one or more structures configured to engage with the external elements of the handle body 402 to control the insertion and positioning of the closure device 100 and the disengagement of the closure device 100 from the delivery system 430. For example, the suture groove 447b of the carriage 438 can accommodate a pin 417 located in the hole 415.

[0113] As shown in Figure 14F, the suture 106 can be wrapped in a loop around the pin 417 during assembly. The frictional engagement of the suture 106 between the pin 417 and the suture groove 447b allows the suture 106 to be held within the carriage 438 during insertion of the closure device 100. After the closure device 100 has been deployed around the blood vessel, the delivery system 430 is detached from the closure device 100 by releasing the suture 106 from the carriage 438. A release button 424 (not shown in Figure 14F) slides proximal toward the pin 417, and the release button fin 419 causes the pin 417 to be pushed into the hole 415. Once the pin 417 is pushed into the hole 415, the suture 106 is released from the pin 417, effectively releasing the suture 106 and the closure device 100 from the delivery system 430.

[0114] The tamper tube 442 may include a suture 106 through which it can pass. As shown in Figure 16, the tamper tube 442 may also include a push wire 452 and a support tube 454. The distal tip 457 of the push wire 452 may have a forked or split shape to help push the closure device 100 out of the delivery system (the forked or split shape may be positioned linearly or at an angle to the push wire 452). Of course, other shapes of the tip 457 are also possible. The proximal end of the push wire 452 includes a push wire bend 477 attached to the portion 450a so that the push wire 452 can be moved by the movement of the portion 450a. The support tube 454 may be used to tamp the cap 102 of the closure device 100 after the anchor 108 has been positioned. The stopper 444 may prevent the implant assembly 426 from slipping out of the distal opening 436 of the handle body 402.

[0115] The closure device 100 may have an anchor 108, a cap 102, and a fluid-blocking component or sealant 104, all configured on sutures 106, as described herein. The sealant 104 may be an active biological material such as polyethylene glycol (PEG), fibrin sealant, a copolymer of glucosamine and N-acetylglucosamine, dextran (a complex branched glucan (a polysaccharide derived from glucose condensation)), polypeptide adhesive structures, adhesive proteins containing L-3,4-dihydroxyphenylalanine (L-DOPA), adhesive proteins containing DOPA and phosphoserine, collagen, polyacrylic acid, polyacrylic acid crosslinked with allyl sucrose or allyl pentaerythritol, polyacrylic acid, crosslinked with divinyl glycol, an acrylic resin polymer composed of methyl-2-cyanoacrylate units, or optionally incorporated into a molded flexible substrate. The sealant material can be activated by a fluid present in the patient's tissue pathway, such as blood or other fluids, and can be protectedly housed inside a sheath or actuator or chamber of a delivery device until placed directly on top of the cap 102.

[0116] Once advanced to the desired position, the sealant 104 may be exposed to blood or body fluids, for example, by removing the sealant 104 from the sheath and positioning it so that it is in direct contact with reactive tissue. This reaction can cause the sealant 104 to expand, absorb blood and other fluids, and bond to the surrounding tissue and cap 102. The sealant 104 can act as an adhesive, "locking" the cap 102 in place on the blood vessel and helping to actively coagulate the entire tissue pathway 22. The chemical composition, quantity, carrier matrix, and dimensions of the sealant 104 can be specifically selected to provide one or more of the following functions: the ability to fix the sealing components (e.g., cap 102) in place, the ability to provide a rapid, leak-free dry close, and the ability to reduce exudation of the tissue pathway.

[0117] For example, the sealant 104 can form a plug having a length of approximately 1 mm to 10 mm, and its length can be adjusted in the patient's body together with the suture 106 after deployment, if necessary. Alternatively, the sealant 104 can extend along the entire length of the tissue pathway 22 and be trimmed to fit the patient. If the sealant 104 is formed in matrix form, the matrix can have an area of ​​approximately 0.012 square inches to 0.12 square inches, approximately 0.12 square inches to 0.6 square inches, or approximately 0.6 to 1.0 square inches. The matrix material can be thin and flexible so that it can be wrapped around the suture in the delivery system so that it fits inside the tube for delivery to the implant site. This results in a fluid-blocking component that optionally includes a matrix containing a sealant, such as PEG or other biocompatible material, with a volume of approximately 0.004 to approximately 0.040 cubic inches, approximately 0.040 to approximately 0.100 cubic inches, or approximately 0.100 to approximately 0.4 cubic inches.

[0118] The sealant 104 may be positioned to be placed on the suture 106. Thus, the sealant 104 may be deployed in a fluid composition without a carrier matrix, or may be formed as part of a carrier matrix, or together with a carrier matrix. For example, the sealant 104 may be positioned around the suture 106 as a generally cylindrical component, may be bonded to the suture 106 itself, may be bonded to the cap 102, and / or combinations or variations thereof are possible. Since the sealant 104 is positioned proximal to the cap 102, the sealant 104 can actively solidify the access passage 22, and optionally, the entire access passage 22 leading to the surface of the skin 16.

[0119] Figures 17A and 17B show a dilator assembly 470 having a dilator tube 456 and a dilator hub 458 that can be assembled to the dilator tube 456. The dilator tube 456 can be inserted into the delivery sheath 440 to expand the opening of the skin 16 and access passage 22 and enable the insertion of the delivery sheath 440. The dilator hub 458 may be configured to be selectively attached to or removed from the delivery sheath 440 via the sheath hub 418. The dilator hub 458 may include a locking arm 459 that can selectively engage with a receiving member 468 of the sheath hub 418 by means of an interlocking fit or friction fit, etc. The dilator tube 456 and / or the dilator hub 458 may be formed from biocompatible materials such as nylon, polyethylene, high-density polyethylene (HDPE), or other polymer materials, but are not limited to these.

[0120] The dilator tube 456 includes distal openings 455a, 455b leading to a distal end 467 and a proximal opening 461 leading to a proximal end. The distal openings 455a, 455b communicate with an internal passage to form fluid markers (e.g., blood markers) that help position the dilator tube 456 within a body cavity. For example, fluids from within a body cavity, such as blood, can flow out through one or both of the distal openings 455a, 455b through the internal passage and out of the proximal opening 461, indicating a specific depth in the tube 456. Although the distal openings 455a, 455b are shown as being located on both sides of the dilator tube 456, it will be understood that the position and number of openings may vary.

[0121] Between the locking arms 459 is a mounting member 463 that assists in attaching the dilator hub 458 to the delivery sheath 440. The mounting member 463 also facilitates the connection of the dilator tube 456 to the dilator hub 458. The mounting member 463 is branchable into a first leg 465a and a second leg 465b. The bifurcated structure allows the mounting member 463 to bend when it engages with the delivery sheath 440, while the mounting member 463 fits into the sheath hub 418 by friction or interference fit.

[0122] The delivery sheath 440 shown in Figures 18A and 18B has a sheath 441 for receiving a dilator tube 456 and for delivering the dilator tube 456 and implant assembly 426 through an access passage 22. A sheath hub 418 can be assembled on the sheath 441 to allow selective attachment of other surgical instruments, such as the dilator tube 456, to the delivery sheath 440. The sheath hub 418 may include, but is not limited to, a receiving member 468 configured to receive surgical instruments and selectively hold them on the delivery sheath 440, such as the locking member 420 of a handle assembly 400 and the locking arm 459 of a dilator hub 458. The receiving member 468 may be a channel or passage formed by a wall 471. The proximal end 443 of the sheath 441 may cooperate with a valve 462 to prevent backflow of fluid to the surgical instruments attached to the delivery sheath 440. The valve 462 is held within the sheath hub 418 by the valve cap 464, and the tension relief member 469 extends distally from the valve cap 464. One or more of the sheath hub 418, sheath 441, valve 462, valve cap 464, and tension relief member 469 can be joined to each other by overmolding bonding techniques, or can be attached to each other using a combination of friction or interference fit and adhesive, thermal, chemical, or other bonding techniques.

[0123] When the dilator assembly 470 is attached to the delivery sheath 440, the mounting member 463 passes through the valve cap 464 and valve 462. One or more ports 473, aligned with the distal openings 455a, 455b, form a fluid path that allows for the determination and placement of the depth of the delivery sheath 440. Furthermore, to provide depth indication of the delivery sheath 440, marks 474 (e.g., 474a, 474b) are provided on the sheath 441. For example, letters, numbers, or other symbols can be used to identify the insertion depth. In one configuration, the first marks 474a are spaced approximately 1 cm apart, and the second marks 474b are spaced approximately 0.5 cm apart from adjacent first marks 474a. It will be understood that the fineness of the depth scale can be changed by placing one or more second marks 474b between adjacent first marks 474a. Furthermore, the spacing of the first mark 474a may range from approximately 0.1 cm to approximately 5 cm, approximately 0.25 cm to approximately 2.5 cm, approximately 0.5 cm to approximately 1 cm, less than approximately 5 cm, less than approximately 4 cm, less than approximately 3 cm, less than approximately 2 cm, less than approximately 1 cm, and less than approximately 0.5 cm.

[0124] As shown in Figures 19A and 19B, the handle assembly 400 can be selectively attached to the delivery sheath 440 by inserting the locking member 420 of the handle assembly 400 into the receiving member 468 of the delivery sheath 440 to form the delivery system 430. The locking member 420 can be made of an elastic material such as flexible plastic, allowing it to bend when inserted into the receiving member 468. By bending the locking member 420, the hook-shaped end 422 can be disengaged, and the handle assembly 400 can be detached from the delivery sheath 440. When the locking member 420 cooperates with the receiving member 468, the chamber nozzle 429 penetrates the valve 462, providing access to the sheath 441 for delivery and deployment of the closure device 100. Once the delivery system 430 is engaged and the closure device 100 is deployed, the slider 450 can be moved distally toward the delivery sheath 440, as shown in Figure 19C, thereby deploying the anchor 108 of the closure device 100.

[0125] Figure 19D is a close-up view of the partially deployed closure device of Figure 19C. The fork-shaped end 457 of the push wire 454 deploys the anchor 108 of the closure device 100 from the delivery sheath 441.

[0126] Method for inserting a closure device using a handle assembly Figures 20A to 23C show an example of how to insert an occlusion device using the deployment system 430. First, the dilator tube 456 can be inserted into the delivery sheath 440. The dilator tube 456 can be selectively attached to the sheath 440 by connecting the dilator hub 458 to the sheath hub 418 in order to maintain the position of the dilator tube 456 within the delivery sheath 440 (Figures 20A to 20B). The dilator tube 456 can be used to stretch the opening and access passage 22 in the skin 16 to allow for the placement of the occlusion device 100.

[0127] Next, as shown in Figure 21B, the dilator hub 458 can be disengaged from the sheath hub 418 and the dilator tube 456 can be removed. The delivery sheath 440 can remain in the access path 22. Figures 21C and 21D show how the handle assembly 400 is connected to the delivery sheath 440. The handle assembly 400 can be selectively connected to the delivery sheath 440 by engaging the connecting member of the handle assembly 400 with the receiving member 468 of the sheath hub 418 of the delivery sheath 440.

[0128] Once the handle assembly 400 is connected to the delivery sheath 440, the operator can press down the proximal lock assembly 421 to unlock the slider 450 and push the slider 450 distally toward the distal end 406 of the handle body 400, as shown in Figure 22. This causes the delivery system 430 to release the anchor 108 into the vascular lumen 12 so that the anchor 108 can contact the vessel wall 14 and be positioned over the puncture or access site 18. Once the slider 450 reaches the distal end 406, the anchor 108 should be (completely) ejected from the delivery system 430, and the cap 102 and fluid barrier component 104 remain in the tamper tube 442 of the implant assembly 426 within the delivery sheath 440. The support tube 454 and implant assembly 426 are housed within the delivery sheath 440 and are therefore not shown in Figure 22.

[0129] Referring to Figure 23A, the slider 450 can be configured to slide along the elongated opening 408 until portion 450b slides through the lock assembly 425, at which point the lock assembly 425 can lock the slider portion 450b to the distal end of the elongated opening 408. The lock assembly 425 can be formed together with the handle body 402, such as having a living hinge connection to the handle body 402, or it can be a separation mechanism connected to or attached to the handle body 402. Once portion 450b is locked by the lock assembly 425, the operator can push down portion 450a to release the interlock end 466a from the interlock end 466b, effectively releasing portion 450a from portion 450b. The portion 450a to which the push wire bend 477 of the push wire 452 is attached can be moved proximal to retract the push wire 452 proximal into the handle assembly 400 from the tissue. By retracting the push wire 452, the anchor 108 can be rotated to be substantially parallel to the vessel wall.

[0130] After the anchor 108 is deployed, the operator gently pulls the handle assembly 400 proximal, engaging and seating the anchor 108 against the inner surface of the vessel wall by the tension applied by the suture 106 connecting the anchor 108 to the handle assembly 400. While maintaining this force, the operator can engage the cap slide 460 by pushing down the plunger 476 and pushing the cap slide 460 distally toward the distal end 406 of the handle assembly 400. Figure 23B shows the cap slide 460 engaging with the tamper tube 442 (or part of the carriage 438) to eject the cap 102 from the delivery system 430 and press the cap 102 against the outer surface of the vessel wall. However, the handle assembly 400 also includes a lockout or interlock assembly to prevent the cap slide 460 from being activated prematurely, and consequently the cap 102 and sealant 104 from being deployed prematurely, details of which will be described later. As will be explained in more detail below, this lockout mechanism prevents the cap slide 460 from moving from its initial position until the anchor 108 is deployed and properly positioned within the blood vessel and a predetermined amount of tension is applied to the suture 106 by the operator.

[0131] After the anchor 108 and cap 102 are in place, the sealant 104 is deployed. This is done by moving the cap slide 460 proximal, which also moves the tamper tube 442 proximal while keeping the support tube 454 fixed. This combination of the proximal movement of the cap slide 460 and the fixed position of the support tube 454 exposes the sealant 104 to the blood and tissue in the tissue pathway 22. Once the sealant 104 is positioned proximal to the cap 102 in the tissue pathway 22, the release button 424 can be operated to release the suture 106 and closure device 100 from the delivery system 430, leaving the sealant 104 in the tissue pathway 22 as shown in Figure 23C. The suture 106 can then be cut below the level of the skin or tissue.

[0132] Lock assembly for vascular occlusion delivery system A lockout or latch assembly incorporated into the delivery system 430 is also disclosed. The disclosed lockout assembly is configured, among other things, to (i) provide the operator with audible, visual, and / or tactile feedback during the operation of the device and during the placement of the occlusion device; (ii) prevent the operator from prematurely deploying components of the implant and / or prematurely removing the delivery device from the patient; (iii) ensure that the elements of the occlusion device are properly positioned and in the correct order; (iv) improve the overall safety of the patient; and / or (v) improve the speed, ease, and efficiency of the placement of the occlusion device.

[0133] For example, a first interlock assembly is provided at the proximal end of the handle 402, thereby preventing the slider 450 from moving accidentally or prematurely from its initial position. When the delivery system 430 is properly connected to the delivery sheath 440 and the operator is ready to introduce the occluded implant 100 into the blood vessel through the delivery sheath 440, the operator must first push down the proximal lock assembly 421, thereby unlocking the slider 450 and allowing the slider 450 to move from the proximal end to the distal end of the handle assembly 400, thereby advancing the internal components of the delivery system 430 distally through the delivery sheath 440. While the lock assembly 421 is shown and described in particular, it will be understood that any of various other configurations having a similar function may be provided.

[0134] A second interlock assembly is configured to interact with a carriage assembly 438 housed within the handle assembly 400. The carriage assembly 438 is configured to deploy the closure device 100, thereby providing substantially immediate hemostasis to the puncture site within the vessel wall. The interlock assembly prevents premature deployment of one or more components of the closure device 100. For example, the interlock assembly prevents the full deployment of the cap seal until the anchor seal (deployed into the vessel) is properly positioned against the inside of the vessel wall. Once the anchor is properly positioned and a predetermined tension is applied, the interlock assembly is released, allowing the cap seal to tighten against the outside of the vessel wall.

[0135] By simultaneously applying a predetermined tensile force, at least the following occurs: (i) the cap seal is positioned at the appropriate angle to the outer surface of the vessel wall; (ii) the spring mechanism retracts to secure the deployment path for the sealant; (iii) the components of the carriage assembly are unlocked, causing the latch that tightens the cap against the vessel wall to rotate; and / or (iv) the anchor is properly positioned against the inner surface of the vessel wall. The operator can then actuate the carriage assembly to tighten the cap against the vessel wall and deploy the sealant.

[0136] The interlock assembly also prevents the sealant from being drawn into the handle assembly when various elements of the handle assembly are retracted during the placement of the closure device and during the removal of the handle assembly from the closure device. The sealant must be positioned relative to the cap seal and remain in place relative to the cap seal. Once the cap seal is positioned relative to the puncture site, the interlock assembly unlocks the components of the carriage assembly, allowing the carriage to move proximal. This proximal movement dislodges the sealant from the sheath, ensuring that the sealant remains in place relative to the cap seal within the tissue pathway leading to the puncture site. Only by remaining in place relative to the cap seal within the tissue pathway can the sealant react with body fluids, expand, and seal the tissue pathway.

[0137] When the sealant is removed from the sheath, the components of the interlock assembly move proximal along the handle assembly. This proximal movement of the interlock assembly components allows the handle and dilator assembly to be removed from the patient while leaving the anchor, cap, sealant, and sutures in place, by releasing or detaching the sutures from the handle assembly. During the process of removing the closure device from the delivery device, the delivery device may produce a "snap" or "click" sound inside the handle, allowing the practitioner to perceive, both audibly and tactilely, that the closure device has been completely disengaged from the handle assembly. Without the interlock assembly, the practitioner may attempt to remove the handle and dilator assembly prematurely, potentially tearing the closure device from the patient and causing further tissue damage.

[0138] To assist the operator in properly deploying the occlusion device, the disclosed handle assembly may include various visual markings and indicators. For example, the operator initially inserts the dilator assembly to provide access to the puncture site. The depth indicator on the dilator assembly allows the operator to visually determine how far the dilator assembly has advanced into the blood vessel and / or tissue pathway. This allows the operator to know whether or not the puncture site has been reached. Once the operator has accessed the puncture site and deployed the anchor into the blood vessel, the markings on the distal end of the handle assembly are visually confirmed to the operator when the cap is positioned relative to the puncture. For example, the markings may be in the form of bars indicating distances of 5, 4, 3, and 2 mm from the puncture site. It should be understood that the fineness of the markings may be more or less adjustable as needed.

[0139] These markings help the practitioner understand their distance from the blood vessel. Furthermore, and / or alternatively, the markings help direct the practitioner to determine how deep they are within the tissue pathway. Specifically, if the practitioner feels tactile or other resistance while deploying the occlusion device, the physician can check the markings and "visualize" how far they are from the puncture site. As the practitioner enters the puncture site and deploys the occlusion device, the components of the interlock assembly begin to work in conjunction with the components of the handle assembly and the slider or carriage assembly to ensure proper deployment of the occlusion device components. Markings can be placed on both sides of the handle assembly, allowing both left- and right-handed practitioners to use the disclosed device.

[0140] Other components within the handle assembly may be coupled with components of the interlock assembly to provide the practitioner with audible feedback in addition to visual and tactile feedback. For example, a slider or carriage assembly configured to deploy a closure device may include grooves or protrusions for mechanical coupling with an interlock assembly component. When the interlock assembly component unlocks a component of the slider assembly, the physician will hear the sound of the interlock assembly component striking the groove or protrusion of the slider assembly.

[0141] Figures 24A–24Q illustrate an interlock or latch assembly 500 that can be used in combination with a carriage 438 (such as the carriage 438 illustrated in Figures 14C–14F and 16) to release the suture 106 from the handle assembly 400, as an alternative to the pin 417 and hole 415 mechanism shown in Figures 14D–14F. Figures 24A–24Q also show the corresponding positions of the closure device 100 during the movement and operation of the latch assembly 500. The interlock or latch assembly 500 is configured to perform the functions of the interlock assembly described herein. Specifically, the closure device 100 (including the anchor 108, cap 102, sealant 104, and suture 106) is shown at various stages of deployment.

[0142] Figure 24A shows the anchor 108 having entered the blood vessel via the fork-shaped end 457 of the push wire 452. The length of the push wire 452 is such that when the slider 450 moves to its most distal position on the handle assembly 400, the anchor 108 can advance into the lumen 12 of the blood vessel 10, slightly beyond the distal end of the delivery sheath 440 (as shown in Figure 24C). At this point, the cap 102 is still located outside the blood vessel and housed within the delivery sheath 440, and the sealant 104 is still housed within the tamper tube 442. Figure 24C shows the delivery sheath 441 immediately after the anchor 108 has been deployed into the blood vessel 10. At this point, the operator can pull the handle assembly 400 back proximal. The suture 106 is connected to the anchor 108 at its distal end and to the handle assembly 400 near its proximal end. As the physician pulls the handle assembly 400 proximal, the suture 106 applies tensile force to the anchor 108. The tension applied to the anchor 108 moves it proximal and seats it over the puncture site 18 against the inner wall of the blood vessel 10. In addition, the length of the suture 106 relative to the length of the push wire 452 is selected so that during the initial proximal movement of the handle assembly 400, the forked end 457 of the push wire 452 detaches from the anchor 108 before the slack in the suture 106 is released. This allows the anchor 108 to change orientation by unfolding from its initial folded pre-unfolded configuration or orientation to a fully unfolded configuration or orientation. The anchor 108 is repositioned before the suture 106 applies tension to pull it against the inner surface of the blood vessel wall.

[0143] As shown in Figure 24B, the latch assembly 500 may have internal components including a first latch or lock lever 502 and a second latch or toggle 504. The first latch 502 and the second latch 504 may be maintained by a latch or connecting pin 506 located at the distal end of the handle body 402 and the proximal side of the chamber assembly 427. Both the first latch 502 and the second latch 504 are firmly coupled to the connecting pin 506, which is rotatably coupled inside the carriage 438. Thus, when a lateral force is applied to the proximal end of the first latch 502, such force causes the first latch 502, the second latch 504, and the connecting pin 506 to rotate together around a pivot point formed by the connecting pin 506. The second latch or toggle 504 may interact with or engage with the push wire 452. The latch assembly 500 can interface with the carriage 438 and be configured to interface with elements housed within and / or positioned on the handle body 402. In some embodiments, the latch assembly 500 is housed within the internal slider 438.

[0144] The first latch 502 may include at least one opening 518 through which a suture 106 can be passed through a pin 520 and formed into a loop. The pin 520 can be mechanically coupled to a slider 522 which can be located within a track 524 on the handle body 402. The slider 522 can also be mechanically coupled to a carriage 438 and a support tube 454. When moved distally, the slider 522 can actuate the support tube 454 to tamp the cap 102 of the closure device 100. When moved proximal, the slider 522 moves the pin 520 proximal, thereby releasing the suture 106 from the delivery system 430. Proximal movement of the slider 522 can also retract the support tube 454 to expose and position the sealant 104.

[0145] The second latch 504 may include a hook 524 configured to receive the push wire bend 477 and selectively lock the push wire 452 in the deployed position. The stopper 444 is mechanically coupled to the support tube 454, and proximal movement of the stopper 444 acts on the support tube 454 to deploy the cap 102. The hook 524 can further receive the stopper 444 and lock the stopper 444 in place, preventing the cap 102 from deploying. When tension is applied to the suture 106, the tensioned suture 106 acts to open the first latch 502, and subsequently release or open the second latch 504, allowing the push wire 452 to move. When the suture tension reaches a threshold minimum (e.g., about 0.8 pounds of force (lbf)), the latch assembly 500 trips, the push wire 452 retracts (e.g., about 15 mm), and the slider 522 is released. The suture tension can be in the range of approximately 0.8 lbf ± 0.3 lbf, such as 0.5 lbf to 1.1 lbf. Such suture tension is optimized for gentle delivery and placement of anchor 108 against the inner wall of the blood vessel and is within the acceptable force range applied by a practitioner trained in percutaneous catheterization procedures.

[0146] As described above, Figure 24B shows the initial locked positions of the first latch 502 and the second latch 504. In this position, the relative positions of the push wire 452, the internal slider 522, and the cap slide 460 are locked or fixed in place. This lockout mechanism prevents the operator from deploying the cap 102 and sealant 104 prematurely or unintentionally. The lockout mechanism allows the cap 102 and sealant 104 to be deployed only after the anchor 108 has been properly positioned inside the blood vessel and over the puncture site, and tension has been applied and maintained via the suture 106.

[0147] In the initial locked position, the hook 524 of the first latch 502 is engaged with the stopper 444 (as shown in Figure 24B). This engagement by the hook 524 prevents the slider 522 and the cap slide 460 (see Figure 23A) from moving distally. When a predetermined tension is applied to the suture 106, the tension causes that portion of the suture 106, which has been looped through the hole 518, to exert force on the proximal end of the first latch 502, thereby causing both latches 502 and 504 to rotate around the pivot point of the connecting pin 506 (both latches 502 and 504 are firmly connected to the connecting pin 506). This rotation causes the hook 524 to rotate and disengage from the stopper 444, thereby allowing the operator to move the slider 522 distally via the cap slide 460 (see Figure 24B). As discussed elsewhere, distal movement of the slider 522 causes the tamper tube 442 and support tube 454 to move distally relative to the delivery sheath 440, deploying the cap 102 and / or pushing the cap 102 up to the outer surface of the vessel wall.

[0148] Furthermore, in the initial locked position, the distal end 505 of the second latch 504 engages with the collar 507. The collar 507 is mechanically coupled to the push wire bend 477, which extends laterally through the hole 509 in the collar 507, as shown in Figure 24B. Also as shown in Figure 24B, in the initial locked position, the spring 510 is held in a compressed state between the distal shoulder of the collar 507 and the inner surface formed in the carriage 438. As described, when sufficient tension is applied to the suture 106, the second latch 504 rotates around the connecting pin 506, and the collar 507 moves proximal under the force of the spring 510 as it expands as a result of its spring force. This proximal movement of the collar 507 also retracts the push wire 452 proximal into the chamber assembly 427 (see Figures 14A and 14B). When released, the spring force of spring 510 rapidly propels collar 507 proximal until it collides with the proximal wall of carriage 438. The collision provides the practitioner with audible and tactile feedback indicating that anchor 108 has been deployed and positioned, that the locking mechanism associated with cap slide 460 has been released, and that the practitioner can proceed to the next step of deploying implant 100.

[0149] Figure 24D shows the initial few millimeters of retraction of the push wire 452. As shown in Figure 24E, the hook 524 rotates in response to the applied suture tension. Otherwise, the hook 524 would always remain in the locked position, preventing the slider 522 from moving. The hook 524 unlocks or rotates only in response to appropriately applied suture tension. Furthermore, the tension applied to the suture 106 also rotates the second latch 504, disengaging it from the collar 507, and moving the collar 507 and the push wire 452 proximal.

[0150] In Figure 24F, the push wire 452 is fully retracted and no longer visible. The anchor 108, part of the suture 106, and the cap 102 are clearly visible.

[0151] The latch assembly 500 may also include a rod or spring guide 508 that extends longitudinally and is connected to the carriage 438 via a push wire bend 477. The proximal end of the rod 508 may include a collar 507 having a hole 509 configured to accommodate the push wire bend 477. The rod 508 may have a spring 510 wound around it, which has a proximal end and a distal end. The proximal end of the spring 510 may be fixed to the collar 507. The distal end of the spring 510 remains detached from the rod 508, allowing the spring 510 to be compressed between the distal internal shoulder formed in the carriage 438 and the collar 507. As shown in Figure 24G, in response to the applied suture tension, the spring 510 depresses, retracting the collar 507 and rod 508 proximal, and pulling the push wire 452 together with them. This causes the distal end of the push wire 452 to retract into the chamber 427 (see Figures 14A and 14B). Retracting the push wire 452 also reduces the possibility of interference with the deployment of the sealant 104.

[0152] When the interlock mechanism of the latch assembly 500 is disengaged and unlocked, the operator can proceed to the next step of deploying the implant 100, namely, advancing and tamping the cap 102 against the outer surface of the vessel wall. This can be done by the operator moving the cap slide 460 distally. The cap slide 460 is mechanically coupled to the slider 522, the slider 522 is mechanically coupled to the stopper 444, and the stopper 444 is mechanically coupled to the tamper tube 442. Thus, the cap slide 460, slider 522, stopper 444, and tamper tube 442 move together as a single unit. Therefore, when the stopper 444 is engaged with the first latch 502, none of the aforementioned elements can be moved distally. However, when unlocked, the operator's distal movement of the cap slide 460 also moves the other coupled components. The travel distance of the tamper tube 454 is constrained by the travel distance of the cap slide 460 and the internal dimensions of the carriage 438 (schematically illustrated in Figures 24I and 24K). In any case, as shown in Figures 24H to 24K, when the stopper 444 advances distally, the tamper tube 442 engages with the proximal surface of the cap 102, pushing the cap 102 distally until it is in close contact with the outer surface of the vessel wall.

[0153] The latch assembly 500 may also include a first slider block 521 located inside the carriage 438 and may include a pin 520. The first slider block 521 is mechanically coupled to the proximal end of the support tube 454. The first slider block 521 has a distal shoulder 523 and a proximal shoulder 525, both of which interact with the stopper 444. As the stopper 444 moves distally, the distal surface of the stopper 444 engages with the distal shoulder 523 of the first slider block 521, and as the stopper 444 moves further distally, the first slider block 521 (and thus the support tube 454) also moves distally. Therefore, when the latch mechanism of the latch assembly 500 is disengaged and unlocked, and the operator moves the cap slide 460 distally, all of the following components: the cap slide 460, slider 522, stopper 444, tamper tube 442, first slider block 521, and support tube 454, move together distally as a single unit. Once these components reach the end of their distal movement and the cap 102 is firmly positioned against the outer surface of the vessel wall, the operator can begin to move the cap slide 460 proximal.

[0154] This proximal movement also causes the stopper 444 and tamper tube 442 to move proximal. However, the support tube 454 remains in its distal position until the stopper 444 moves proximal enough distance to engage with the proximal shoulder 525 of the first slider block 521. The distance between the distal shoulder 523 and the proximal shoulder 525 of the first slider block 521 is approximately the same as the length of the sealant 104 (e.g., about 5-8 mm). Thus, this proximal movement of the tamper tube 442 relative to the support tube 454 exposes substantially the entire length of the sealant 104 to the adjacent tissue and blood in the surrounding tissue pathway. The support tube 454 remaining in a fixed position while the tamper tube 442 retracts helps ensure that the sealant 104 remains pressed against the proximal surface of the cap 102 while it absorbs surrounding fluids and expands in the tissue pathway. When the stopper 444 engages with the proximal shoulder 525 of the first slider block 521, further proximal movement of the cap slide 460 causes the tamper tube 442 and the support tube 454 to retract together until the cap slide 460 reaches the proximal end of its movement.

[0155] In some embodiments, the first slider block 521 may house a pin 520 that can hold a suture loop 526. The first slider block 521 may also have a window or channel that can release the suture loop 526 when release is initiated by the slider 522. Furthermore, the latch assembly 500 may also include a pin body 528 that may include a wedge 530 having an inclined surface and a vertical surface. The inclined surface can help maintain the stopper in a locked position when the stopper 444 is latched or accepted by the first latch 502. When the first latch 502 is released by pulling the suture 106, the stopper 444 is released. The slider 522 can then be moved distally to pack the cap 102, and then proximal to release the suture 106 from the bolt or pin 520. For example, Figure 24H shows a cap 102 and a tamper tube 442 configured to move the cap 102 distally toward the anchor 108. As the first slider block 521 moves distally, the cap 102 advances distally. The sealant 104 is positioned adjacent to the cap 102 and remains contained within the tamper tube 442.

[0156] Figures 24J and 24L show the deployment of the sealant 104 and the retraction of the tamper tube 442 to expose the sealant 104 to blood and other bodily fluids. The support tube 454 remains in place (i.e., fixed) and holds the sealant 104 in place relative to the (now deployed) cap 102 even as the tamper tube 442 is retracted. Figure 24N shows the sealant 104 completely removed from its sheath and exposed. At this point, the tamper tube 442 and support tube 454 can move together proximal to each other as a single unit via the proximal movement of the slider 522, stopper 444, and first slider block 521. In Figure 24P, the proximal end of the suture 106 is released from the carriage 438 (described later) by continuing to retract the tamper tube 442 and support tube 454 via the proximal movement of the slider 522, stopper 444, and first slider block 521, thereby allowing for complete separation of the delivery device from the closure device 100.

[0157] Figures 25A and 25C show a bottom view of the latch assembly 500, illustrating the release of the suture loop 526 from the pin 520. Initially, as shown in Figure 25A, the proximal end of the suture 106 terminates in the suture loop 526, which is wound around the pin 520 extending through a recess 529 formed within the carriage 438. At this point, the suture loop 526 is constrained by the pin 520, which is mechanically coupled to the proximal end of the pin body 528. The distal end of the pin body 528 is positioned with an elastic, flexible finger 530 configured to interact with a stopper 444. Figure 25A shows the initial position and positional relationship of the pin body 528 up to the point when the cap 102 and sealant 104 are deployed and the tamper tube 442 and support tube 454 are retracted proximal. At some point during the proximal movement of the tamper tube 442 and support tube 454, the proximal shoulder 445 of the stopper 444 comes into contact with the distal end of the finger 530 of the pin body 528. As the stopper 444 moves further proximal, the pin body 528 also moves proximal. Such proximal movement of the stopper 444, actuated via the cap slide 460 through the slider 522, also causes the pin 520 to move proximal, releasing the suture loop 526 and suture 106 from the device. A "click" is heard, indicating that the suture 106 has been released from the device and that it is safe to remove the device from the patient.

[0158] Figures 26A–26F show another embodiment of the lockout or latch assembly 600. The disclosures and descriptions relating to the latch assembly 500 described herein are also applicable to the latch assembly 600, and similar structures are therefore given the same reference numerals. In some embodiments, the latch assembly 600 is housed within the carriage 438. The latch assembly 600 is configured to prevent proximal movement of the sealant so that the sealant 104 cannot detach from the cap 102 when the tamper tube 442 is retracted to "remove" the sealant 104 from the sheath. For example, after the cap 102 has been pressed against the puncture site of the blood vessel, the practitioner moves the tamper tube 442 proximal to expose the sealant 104 to blood and other bodily fluids, causing the sealant 104 to expand. The latch assembly 600 is configured to ensure that the sealant 104 remains positioned relative to the cap 102 and does not return into the delivery sheath when the tamper tube 442 is retracted.

[0159] The latch assembly 600 may include a bearing surface 625 formed within the carriage 438, the bearing surface 625 comprising a plurality of teeth 620. The number of teeth 620 may vary. For example, Figures 26A–26D illustrate an embodiment in which the bearing surface 625 includes only four teeth 620 positioned close to the distal end of the bearing surface 625, while Figures 26E–26F illustrate an embodiment in which the bearing surface 625 includes a larger number of teeth 620 positioned along a substantial portion of its surface. In either case, the teeth 620 may be angled toward the distal end of the bearing surface 625 to provide a ratcheting action when the ratchet 630 (see below) moves distally relative to the bearing surface 625. In addition, the angle of the teeth 620 also prevents the ratchet 630 from moving in the opposite (proximal) direction whenever a complementary portion of the ratchet 630 engages with any of the teeth 620.

[0160] The ratchet 630 has an elastic, flexible arm 632 that is complementary to the teeth 620 of the bearing surface 625 and terminates with one or more teeth (not shown) configured to mesh. The ratchet 630 also engages with and / or connects with the stopper 444 as well as the tamper tube 442 and the support tube 454. As described elsewhere, the support tube 454 can be coaxially positioned within the tamper tube 442 and can also pass the suture 106 through.

[0161] As the stopper 444 is moved distally, the tamper tube 442 and the support tube 454 move together. During this distal movement, the stopper 444 engages with the ratchet 630, pushing the ratchet 630 distally with it. As the first slider block 630 moves distally, the flexible arm 632 also moves distally, moving along the bearing surface 625 and bending laterally as it moves along the curved path of the bearing surface 625. At a specific point in the distal movement, the teeth (not shown) of the arm 632 engage with the teeth 620 of the bearing surface 625. As it moves further distally, the flexibility and elastic nature of the arm 632 allows its teeth to ratchet from tooth to tooth on the bearing surface 625, thereby providing the operator with both audible and tactile feedback. Once the teeth are engaged, the relative positions of the components are maintained even if the operator releases the device at some point in the process. In other words, the inclined orientation of the engaged teeth prevents premature or undesirable proximal movement of the tamper tube 442 and support tube 454 until they reach the desired position.

[0162] After the cap 102 is properly positioned and tightened by the operator, the stopper 444 is pulled in proximal direction. As will be described later, this proximal movement of the stopper 444 disengages the teeth (not shown) of the arm 632 from the teeth 620 of the bearing surface 625, "unlocking" the ratchet 630. For example, as seen in Figure 26E, the ratchet 630 engages with the teeth 620. In Figure 26F, as the stopper 444 begins to move proximal, it pushes the flexible arm 632 laterally, thereby bending the flexible arm and disengaging it from the teeth 620 of the bearing surface 625. Specifically, the stopper 444 pushes up the ramp 635 and contacts the projection 638. When the stopper 444 moves the ramp 635 upward and mechanically engages with the projection 638, the force applied by the stopper 444 causes the flexible arm 632 of the ratchet 630 to bend away from the teeth 620, disengaging it. The orientation of the teeth 620 is such that it prevents the ratchet 630 from moving proximal. Once the flexible arm 632 of the ratchet 630 is disengaged from the teeth 620, the entire ratchet 630 can be moved proximal without interference from the teeth 620.

[0163] During the initial proximal movement of the stopper 444 in the proximal direction, the latch assembly 600 holds the support tube 454 stationary. For example, the tamper tube 442 may be held stationary during the first approximately 6 mm (e.g., 5–8 mm) of proximal movement of the stopper 444. This action "detaches" the sealant 104 from its sheath, resulting in its complete release within the patient's tissue pathway without movement or deviation from the tissue pathway. As previously mentioned, the sealant 104 may have a length of approximately 5 mm.

[0164] After the initial 6 mm proximal movement is complete, the tamper tube 442 and support tube 454 move together again to the end of the proximal movement for the stopper 444. The latch assembly 600, similar to the embodiments described above and illustrated in Figures 24A to 25C, then unfolds at the final part of the movement of the slider 552 to release the delivery device from the patient's tissue pathway and release the suture 106 from the internal suture pin 520.

[0165] In some embodiments, components of the latch assemblies 500, 600 (e.g., pin 520, first latch 502, and second latch 504) may be held outside the path of the stopper 444 by a release pin (not shown). The release pin can be displaced so that it is in the path of the stopper 444 when the stopper 444 compresses the cap 102 (e.g., near the distal end of the stroke of the stopper 444), releasing the latch assemblies 500, 600. Thus, in the proximal stroke of the stopper 444, the latch assemblies 500, 600 are in the path of the stopper 444 and can be tripped, allowing for the release of the suture 106 and disengagement of the delivery device.

[0166] Figures 27A–27F show another embodiment of the latch assembly 700. Disclosures and descriptions relating to other latch assemblies described herein are also applicable to the latch assembly 700, and similar structures are therefore given the same reference numerals. Similar to the latch assemblies 500 and 600, the components of the latch assembly 700 are housed within a carriage 438 and can be mechanically interlocked with the slider 450. As seen in the figures, the carriage 438 has a grooved or other shaped body, as shown in Figures 14A, 14E–14F, and 16. In some embodiments, these grooves and / or shapes are designed and / or configured to receive and interact with various components of the latch assemblies described herein (e.g., 500–700).

[0167] As shown in Figures 27A to 27B, another embodiment of the latch assembly 700 may include a latch 502 having a hook 524. The hook 524 is configured to receive a stopper 444 and lock the stopper 444 in place. While the latch assemblies 500, 600 described and illustrated in Figures 24A to 26F are described as including a first latch 502 and a second latch 504, the latch assembly 700 may include a single latch 502 that incorporates the functions of both the first and second latches (in a single part) as described in relation to Figures 24A to 26F. The latch assembly 700 also includes a bolt body 521 connected to a pin 520. In some embodiments, the bolt body 521 is similar to both the first slider block 521 and the pin body 528 of the latch assembly 500. The bolt body 521 of the latch assembly 700 can provide similar functionality to both the first slider block 521 and the pin body 528 described herein. Similar to the latch assemblies 500 and 600 described above, the suture thread 106 is looped around the pin 520 and is released from the pin 520 only when the cap 102, anchor 108, and sealant 104 are properly positioned.

[0168] Figure 27C shows an enlarged view of the latch assembly 700. It is clearly visible that the hook 524 of the latch 502 receives and engages with the stopper 444, preventing the stopper 444 from moving distally until the hook 524 rotates and disengages from the stopper 444. The bolt body 521 and pin 520 are also clearly shown. The suture 106 is shown passing through the bolt body 521, but the suture 106 loops around the pin 520. The suture 106 may also be one large loop, with the middle portion of the suture 106 looped around the pin 520, and both ends of the suture 106 passing through the cap 102 and securing to the anchor 108. The bolt body 521 and pin 520 will be described in more detail below.

[0169] The latch assembly 700 also includes a spring 510 wound around a spring guide 508. The spring guide 508 is configured to accommodate a push wire having a bend 477, similar to the rod 508 described with respect to the latch assembly 500. As is better seen in Figure 27A, the spring 510 is also wound around a rod 512 that helps maintain the spring force of the spring 510. Together with the spring 510 and the rod 512, the spring guide 508 sets a certain amount of spring load on the suture 106. When the operator pulls the device back after delivering the anchor 108, cap 102, and sealant 104, the spring force causes the spring guide 508 to retract, pulling the push wire 452 with it (through the movement of the push wire bend 477). When the spring guide 508 retracts by a set amount (and thus the fork-shaped end 457 of the push wire 452 is pulled away from the anchor 108), the spring guide 508 comes into contact with a projection inside the carriage 438, resulting in a "click" sound being heard.

[0170] This audible feedback indicates that the push wire 452 has been removed from the anchor 108, and that the practitioner can proceed to the next step in the procedure. The spring guide 508 also interacts with the latch 502 and the hook 524. Specifically, a notch in the spring guide 508 engages with the latch 502. When the practitioner pulls the device back and applies force to the suture 106, the latch 502 is released, freeing the spring guide 508. As already described, pulling the device back and applying force to the suture 106 also causes the spring guide 508 to retract, and with it the push wire 452 is pulled back. The practitioner hears audible feedback (e.g., a "click") when the spring guide 508 has moved sufficiently proximal to remove the forked end 457 of the push wire 452 from the anchor 108. Unlocking the latch 502 also releases the stopper 444, allowing it to move distally and tighten the cap 102 around the blood vessel.

[0171] As seen in Figures 27D–27F, the stopper 444 also interacts with the ratchet 630. As is most clearly seen in Figure 27F, the ratchet 630 includes a ramp 635 that interacts with a notch 445 of the stopper 444. This ramp 635 prevents the stopper 444 from moving proximal. As the carriage 438 moves distally, the ratchet 630 moves along the arrangement of teeth 620 (see Figures 27D–27E). The ratchet 630 and the stopper 444 move together as a single unit during the distal movement of the carriage 438. When the carriage 438 completes its distal stroke, the stopper 444 deploys the cap 102 and sealant 104.

[0172] The array of teeth 620 includes a ramp 625. As the first slider block 630 moves distally along the array of teeth 620 beyond the ramp 625, the ramp 635 is removed from the proximal path of the stopper 444. The stopper 444 can then be moved proximal, causing the ramp 635 to be moved "upward". The stopper 444 strikes a projection 638 of the ratchet 630, and the stopper 444 and ratchet 630 move proximal together. Moving the stopper 444 (and ratchet 630) proximal causes the tamper tube 442 to move proximal, thereby exposing the sealant 104 from the sheath.

[0173] While the tamper tube 442 is moved proximal, the sealant 104 is held in place within the tissue tract (and maintains its position relative to the cap 102). When the sealant 104 is removed from the sheath in this way, it is exposed to the blood and other bodily fluids within the tissue tract while retaining its position within the tissue tract. The sealant 104 can then react with and absorb these fluids, thereby expanding and coagulating within the tissue tract.

[0174] As briefly stated, the suture 106 is looped around the pin 520 to prevent premature release of the suture 106 from the device, for example, before the anchor 108, cap 102, and / or sealant 104 are properly positioned and clamped around the vessel wall. As is evident from Figure 27C, the pin 520 is attached to a single piece of the bolt body 521. After the stopper 444 disengages the ratchet 630 from the array of teeth 620, the stopper 444 and ratchet 630 can move proximal as a single unit. As briefly stated, the proximal movement of the stopper 444 and ratchet 630 removes the sealant 104 from the tamper tube 442. The proximal movement of the stopper 444 and ratchet 630 also releases the suture 106 from the pin 520.

[0175] Specifically, the stopper 444 engages with the wing of the bolt body 521 such that further proximal movement of the stopper 444 also moves the bolt body 521 proximal. Briefly referring to Figures 28C to 28D, the proximal movement of the bolt body 521 removes the pin 520 from the channel having a distance D1. Once the pin 520 is removed from the channel, the suture 106 can slide off the pin 520, thereby freeing the suture 106 from the device. The practitioner can then remove the device from the patient and cut the suture 106 to the appropriate length. For example, as already described, the practitioner can push down on the patient's skin or tissue and cut the suture 106 so that it is positioned directly beneath the skin or tissue.

[0176] In some embodiments, the channel distance D1 is approximately 0.050 inches. The distance D1 can be a distance in the range of approximately 0.040 to 0.060 inches, or within the range established by any two of the aforementioned values, such as 0.045, 0.048, 0.055, 0.058 inches. In some embodiments, the channel having distance D1 is formed as part of the carriage 438. As described elsewhere, the carriage 438 may have grooves or other shapes for accommodating, coupling, and / or interacting with various components of the disclosed latch assembly.

[0177] Figures 28A–28D show alternative embodiments of the slider, which may be similar to slider 522 (Figures 24A–25C) or cap slide 460 (Figures 13A and 14A). Figure 28A shows a slider 710 integrated into the distal end of a handle assembly, such as handle assembly 400, which will be described elsewhere. The slider 710 is interlocked with the handle. As seen in Figure 28B, the slider 710 has two latches or fingers 712 and 715. The fingers 712 and 715 are configured to engage with internal elements of latch assemblies 500, 600 and / or 700.

[0178] When stopper 444 moves distally, it bends finger 712 and is trapped between fingers 712 and 715. Finger 712 not only allows slider 710 to apply distal force to stopper 444, but also has a shape that locks slider 710 to handle body 402 (in its initial state). When bent, the interlock shape of slider 710 bends outward from the handle interlock shape. The bending element (e.g., finger 712) cannot return to its interlocked geometric shape or position, thereby keeping slider 710 (and handle assembly 400) unlocked. This prevents the practitioner from moving slider 710 until slider 450 has moved distally or forward by a predetermined distance. While separate sliders 450 and 710 (and other sliders, slides, buttons, etc. having similar or related movements and functions) are referenced, it will be understood that the functions and actions associated with sliders 450 and 710 (and other sliders, slides, buttons, etc. having similar or related movements and functions) can be combined with any number of sliders, slides, buttons, etc. (e.g., one slide, two slides, three or more slides, etc.). Therefore, it will be understood that one or more sliders, slides, buttons, etc. can be used to perform various functions and actions described herein. For example, but not limited to, one slider can perform all the functions and actions of sliders 450 and 710 (or other sliders, slides, buttons, etc. having similar or related movements and functions).

[0179] For example, as seen in Figure 28C, the carriage 438 (which moves the stopper 444) is in its final distal position where the stopper 444 is positioned distal to either of the fingers 712 and 715. There is interference between the finger 712 and the stopper 444. As the stopper 444 moves proximal, it passes over the finger 712 and is positioned between the fingers 712 and 715.

[0180] Alternative delivery system Figures 29A–29D and 30A–30C show additional alternative delivery systems. Figures 29A–29D show another dual-slide delivery system similar to those shown and described in relation to Figures 12–28D. Figures 30A–30C show a similar delivery system, but this consists of only a single slide.

[0181] For example, delivery system 430' may be the same as delivery system 430, and therefore the same reference number is used. Delivery system 430' may include a handle assembly 400' and a delivery sheath 440'. The handle assembly 400' may be configured to be selectively attached to the delivery sheath 440'. When attached to the delivery sheath 440', the handle assembly 400' can be used to insert an occlusion device, such as an occlusion device 100.

[0182] The handle assembly 400' may include a handle body 402' having a proximal end 404' and a distal end 406', one or more actuators (such as sliders 450' and slider 460'), and elongated openings (e.g., openings 408' and 412') configured to provide tracks for such sliders. The slider 450' can slide along the elongated opening 408' when engaged by the operator and can be selectively locked in place by a lock assembly in a manner similar to that described with respect to system 430. The closure device 100 can be deployed by sliding or moving the slider 450' along the elongated opening 408'. As described with respect to the previous embodiment, the anchor 108 can be deployed by the operation of the slider 450', and then the cap 102 can be deployed by the operation of the cap slide 460'.

[0183] The handle assembly 400' is shown to similarly include a connecting member 416' at the distal end 406' of the handle body 402'. The connecting member 416' allows for selective attachment of the handle body to the sheath hub 418' of the delivery sheath 440'. Similar to the delivery system 430', the delivery system 430' is shown to have a dilator assembly 470' which includes a dilator tube 456' and a dilator hub 458'.

[0184] Similar to the delivery system 430', an implant assembly 426' is provided, which includes occluding devices such as occluding device 100, a tamper tube 442', and a carriage 438'. A chamber assembly 427' similar to the chamber assembly 427' is also provided. The chamber assembly 427' is shown in a somewhat different configuration, as illustrated. As shown in Figure 29C, the internal structure of the chamber assembly 427' can be configured in a funnel-shaped structure such that the anchor 108 and / or cap 102 fold inward on themselves as they advance from the wider end of the funnel chamber toward the narrower width (e.g., diameter) associated with the distal end of the chamber assembly 427'. This allows the anchor 108 and cap 102 to advance through the associated tube in a folded configuration, and the anchor and cap can unfold once they exit such a tube. When using the delivery system 430', the procedure steps can be very similar to those described with respect to system 430. Referring to the numbers 1-4 and the associated directional arrows on the handle 400', the practitioner can first advance the slider 450' forward (number 1) to advance the closure device 100 relative to the housing body 402'. For example, by advancing the slider 450' forward, the implant component is advanced to a stopping position that produces an audible and tactile "click" sound, and the anchor is fully ejected from the sheath. The practitioner can then move the entire handle body 402' slightly backward, as indicated by number 2 and the associated directional arrow, to pull the anchor 108 against the vessel wall. For example, by moving the entire handle body 402' slightly backward, the anchor 108 is pulled upward against the inner wall of the vessel until the pressing force along the suture is sufficient to trip the interlock latch against the vessel wall. The activation of the interlock latch releases the lock on the side slide 460', simultaneously releasing the spring guide and retracting the push wire fork to a position where it is close to the sealant material located inside the tamper tube 442'.Next, the operator can deploy the cap 102 by pushing the slider 460' forward, as indicated by the number 3 and the associated directional arrow. For example, pushing the slide 460' forward causes the tamper tube 442' and support tube 454 positioned within it to advance, and then the cap 102 advances until it stops against the outer vessel wall, while the instrument handle holds the anchor seal against the inner wall of the vessel by maintaining tension on the suture. Following this, the slider 460' can be pulled backward, as indicated by the reference numeral 4 and the associated directional arrow, to remove the sealant from the sheath and then release the suture 106. In particular, pulling the slider 460' backward first removes the sealant material located inside the tamper tube 442' from the sheath, while the sealant components are held in place on the cap seal 102 by the support tube 454 (see, for example, Figure 24N). Continuing to pull slider 460' backward causes the suture latch to move backward, resulting in the pin located within the suture latch disengaging from the suture loop. In some cases, the support tube may or may not move backward.

[0185] The delivery system 430” shown in Figures 30A and 30B may otherwise be similar to the delivery system 430 etc. described herein, and therefore similar reference numerals are used. The delivery system 430” may include a handle assembly 400” and a delivery sheath 440”. The handle assembly 400” may be configured to be selectively attached to the delivery sheath 440”. When attached to the delivery sheath 440” the handle assembly 400” can be used to insert an occlusion device, such as an occlusion device 100.

[0186] The handle assembly 400” may include a handle body 402” having a proximal end 404” and a distal end 406”; an actuator (such as a single slider 450”); and an elongated opening 408” configured to provide a track for such a slider. When operated by a practitioner, the slider 450” can slide along the elongated opening 408”. The slider 450” can perform multiple functions, such as deploying the closure device 100, as well as pulling the anchor 108 against the vessel wall, and deploying the cap 102.

[0187] The handle assembly 400” is shown to similarly include a connecting member 416” at the distal end 406” of the handle body 402”. The connecting member 416” allows for the selective attachment of the handle body to the sheath hub 418” of the delivery sheath 440”. Similar to the delivery system 430” the delivery system 430” is shown to have a dilator assembly 470” having a dilator tube 456” and a dilator hub 458”.

[0188] Similar to the delivery system 430”, an implant assembly 426”, including an occluding device such as the occluding device 100, a tamper tube 442”, and a carriage 438”, is provided. A chamber assembly 427”, similar to the chamber assembly 427”, is also provided. When using the delivery system 430”, the procedure step may include advancing the first slider 450”, to a first stopping position (figure 1) in order to advance the occluding device 100 relative to the housing body 402”. When the slider 450”, is first advanced, the forward and downward pressure on the slider unlocks the slider from its attachment to the handle body, allowing the slider to move freely forward. Once advanced, the practitioner can pull the entire handle body 402”, slightly backward, as indicated by figure 2 and the associated directional arrow, to pull the anchor 108 against the vessel wall. Next, the practitioner can extend the cap 102 by pushing the slider 450" further forward to a second stopping position, as indicated by the number 3 and the associated directional arrow. Pushing the slider 450" forward to such a stopping position causes the cap 102 to extend, firmly gripping the blood vessel between the anchor and the cap. Subsequently, the slider 450" can be pulled backward, as indicated by the symbol 4 and the associated directional arrow, to detach the sealant from the sheath and release the suture 106. In particular, pulling the slider 450" backward detaches the sealant material on the cap from the sheath, and moving it further backward to the stopping position releases the suture.

[0189] Figures 31A to 31C show a single-slider configuration similar to that shown in Figures 30A to 30C, but the sheath hub, delivery sheath, dilator hub, dilator assembly, and dilator tube are similar to the delivery system shown in Figures 29A to 29D, which includes a double slide.

[0190] It will be understood that various configurations and associated procedural steps are possible, including advancing the closure device 100 into the body cavity, pulling the anchor 108 against the blood vessel wall, deploying the cap 102, and finally releasing the suture 106 after the closure device 100 has closed the puncture access site 18.

[0191] Method for inserting a closure device using a handle assembly with a latch assembly To deliver the occlusion device 100 using a handle assembly 400 having a latch assembly 500, 600, or 700, a dilator tube 456 can first be inserted into the delivery sheath 440. The dilator tube 456 can be selectively attached to the sheath 440 by connecting a dilator hub 458 to a sheath hub 418 to maintain the position of the dilator tube 456 within the delivery sheath 440 (Figures 20A-20B). The dilator tube 456 can be used to expand the opening and access passage 22 in the skin 16 so that the occlusion device 100 can be placed.

[0192] Next, as shown in Figure 21B, the dilator hub 458 can be disengaged from the sheath hub 418 and the dilator tube 456 can be removed. The sheath 441 can remain in the access path 22. Figures 21C and 21D show how the handle assembly 400 is connected to the delivery sheath 440. The handle assembly 400 can be selectively connected to the delivery sheath 440 by engaging the connecting member 420 of the handle assembly 400 with the receiving member 468 of the sheath hub 418 of the delivery sheath 440.

[0193] Once the handle assembly 400 is connected to the delivery sheath 440, the user can press down the proximal lock assembly 421 to unlock the slider 450 and push the slider 450 distally toward the distal end 406 of the handle body 400, as shown in Figure 22. This causes the delivery system 430 to release the anchor 108 into the vascular lumen 12 so that the anchor 108 can be positioned on the puncture site 18 by contacting the inner wall 14A of the vascular vessel. Once the slider 450 reaches the distal end 406, the anchor 108 should be discharged from the delivery system 430, and the cap 102 and sealant 104 remain in the tamper tube 442 of the implant assembly 426 within the delivery sheath 440.

[0194] Referring to Figure 23A, the slider 450 can be configured to slide along the elongated opening 408 until the slider 450 slides distally beyond the lock assembly 425, at which point the lock assembly 425 can lock the slider 450 to the distal end of the elongated opening 408. The lock assembly 425 can be formed together with the handle body 402, such as having a living hinge connection with the handle body 402, or it can be separated from it.

[0195] By moving the slider 450 through the lock assembly 425, the engagement of the lock assembly 425 can activate or trip the latch assembly 500, engaging the first latch 502 with the stopper 444 and locking the stopper 444 (and substantially the implant assembly 426) in place within the delivery sheath 440. The engagement of the first latch 502 activates the second latch 504, moving the second latch 502 to the locked position, which allows selective holding of the push wire bend 477 of the push wire 452 of the implant assembly 426.

[0196] Next, the operator can pull back the handle assembly 400 along the axis of the device (for example, at a 45-degree angle to the tissue path 22) to apply tension to the suture 106 and ensure proper placement of the anchor 108. When tension is applied to the suture 106 by the operator, the suture loop 526, which is wound in a loop around the pin 520, causes the suture 106 to apply downward pressure to the first latch 502, releasing the stopper 444 from the first latch 502. The release of the first latch 502 releases the push wire bend 477 to the second latch 504, allowing the spring 510 to depressurize and push the rod 508 proximal. The proximal movement of the rod 508 retracts the push wire 452 from the closure device 100, so that the fork-shaped end 457 of the push wire 452 is at least near the proximal end of the sealant 104 and does not obstruct the placement of the sealant 104.

[0197] When spring 510 is released, it can pull the push wire 452 back into the tamper tube 442. The user can feel when spring 510 is acting. Slider 522 and tamper slider 528 may not move to tamp cap 102 until spring 510 is actuated. This mechanism ensures that anchor 108 is reliably and optimally sealed against the inner wall of the artery.

[0198] Next, the slider 522 engages with the tamper slider 528 to tamp the cap 102 and securely fit it. Then, the slider 522 is pulled in proximal, retracting the support tube 454 proximal, and the fluid shut-off component 104 can be passively removed from the sheath. The tamper tube 442 can be locked in a position near the fluid shut-off component to maintain the position of the fluid shut-off component 104 while it is in place. The tamper tube can be retracted proximal by the operation of the slider by approximately 4 mm to 8 mm, approximately 5 mm to 7 mm, or approximately 5.5 mm to 6.5 mm. The support tube 454 can be retracted so as not to interfere with the placement of the fluid shut-off component 104.

[0199] When the support tube 454 is retracted by engaging the slider 522, the slider 522 releases the suture loop 526 to the pin 520, thereby freeing the suture 106 and the closure device 100 from the delivery system 430.

[0200] In some embodiments, a method for deploying or inserting an occluding device using a disclosed handle assembly includes advancing the delivery sheath and / or dilator on a wire. This method also includes checking for blood marks and removing the dilator and wire. The method further includes connecting the occluding device to the delivery sheath and engaging the slider to deliver the anchor into the blood vessel. Furthermore, the method may include gently pulling back the handle assembly (about 2 cm) until a second slider (e.g., a cap slide) is released. The practitioner hears and feels a "click" from the locking mechanism indicating that the second slider is released.

[0201] This method includes the steps of advancing a second slider to push the cap toward the blood vessel and tightening the occluding device around the vessel wall. After tightening the occluding device, the degree of hemostasis should be assessed and, if necessary, additional tightening of the occluding device should be performed. Such tightening can be performed by pulling or pulling the handle attached to the occluding device and / or delivery sheath proximal. This method also includes the step of retracting the second slider until a stopper "click" is heard and the device is removed.

[0202] Additional terms and definitions The articles “a,” “an,” and “the” are intended to indicate that there is one or more elements in the preceding description. The terms “comprising,” “including,” and “having” are intended to be comprehensive and mean that there may be additional elements other than those listed. Furthermore, it should be understood that any reference in this disclosure to “one embodiment” or “embodiment” is not intended to be construed as excluding the existence of additional embodiments that also incorporate the listed features. Numbers, percentages, ratios, or other values ​​described herein are intended to include those values ​​and other values ​​that are “about” or “approximately” the stated values, as understood by those skilled in the art as encompassed by the embodiments of this disclosure. Accordingly, the stated values ​​should be interpreted broadly enough to include values ​​that are at least sufficiently close to the stated values ​​in order to perform the desired function or achieve the desired result. The stated values ​​may include values ​​within 5%, 1%, 0.1%, or 0.01% of the stated value, including at least the variation expected in a suitable manufacturing or manufacturing process.

[0203] Those skilled in the art will understand, in consideration of this disclosure, that equivalent structures do not deviate from the spirit and scope of this disclosure, and that various changes, substitutions, and modifications can be made to the embodiments disclosed herein without deviating from the spirit and scope of this disclosure. Equivalent structures including functional “means plus function” clauses are intended to encompass the structures described herein as performing the enumerated functions, including both structural equivalents that operate in the same manner and equivalent structures that provide the same functions. The applicant expressly intends not to use means plus function or other functional claims in any claim except for claims in which the phrase “means for” is expressed together with the relevant function. Any additions, deletions, and modifications to embodiments within the meaning and scope of the claims should be incorporated by the claims.

[0204] As used herein, the terms “approximately,” “about,” and “substantially” refer to quantities close to the stated quantity that still perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to quantities within the range of less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity. Furthermore, it should be understood that any direction or reference frame in the foregoing description is simply a relative direction or movement. For example, expressions such as “up” and “down” or “above” and “below” simply describe the relative position or movement of the elements in question.

[0205] Various values ​​and ranges are disclosed herein. Additional ranges may be established between the values ​​disclosed herein as examples of specific parameters. All such ranges are assumed and included within the scope of this disclosure.

[0206] Any direction or reference frame described herein merely indicates a relative direction (or movement). For example, expressions such as “top,” “bottom,” “up,” “down,” “above,” and “below” simply describe the relative position or movement of the related elements as illustrated, and it should be understood that these may change as the structure is rotated, moved, or the viewpoint changes.

[0207] The following are some further exemplary embodiments of the present invention. These are presented for illustrative purposes only and are not intended to limit the scope of the invention in any way. Furthermore, any exemplary embodiment can be combined with one or more exemplary embodiments.

[0208] Embodiment 1. A vascular occlusion device for achieving substantially immediate hemostasis at a puncture site in the wall of a blood vessel, comprising: an intravascular anchor having one or more suture attachment points; an extravascular cap having a lumen; a sealant; and a suture connected to at least one of the one or more suture attachment points of the intravascular anchor, connecting the intravascular anchor to the extravascular cap and sealant through the lumen of the extravascular cap and the sealant, wherein each of the intravascular anchor, extravascular cap, sealant, and suture is formed of a bioabsorbable material.

[0209] Embodiment 2. The vascular closure device according to Embodiment 1, wherein the intravascular anchor comprises an elongated body having a flexible member and a keel.

[0210] Embodiment 3. A vascular closure device according to any one of Embodiments 1 to 2, wherein the extravascular cap is formed of a flexible material.

[0211] Embodiment 4. A vascular occlusion device according to any one of Embodiments 1 to 3, wherein the sealant comprises polyethylene glycol (PEG).

[0212] Embodiment 5. A vascular closure device according to any one of Embodiments 1 to 4, wherein the suture has a distal suture portion and a proximal suture portion.

[0213] Embodiment 6. A vascular closure device according to any one of Embodiments 1 to 5, wherein the diameter of the lumen of the extravascular cap is smaller than the diameter of the distal suture portion.

[0214] Embodiment 7. A vascular closure device according to any one of Embodiments 1 to 6, wherein the intravascular anchor comprises a bioabsorbable material.

[0215] Embodiment 8. A vascular closure device according to any one of Embodiments 1 to 7, wherein the intravascular anchor has a plurality of ribs that radiate from the keel to the raised edge of the elongated body.

[0216] Embodiment 9. The vascular occlusion device according to any one of Embodiments 1 to 8, wherein the sealant can expand up to four times its original size when introduced into a fluid.

[0217] Embodiment 10. A vascular occlusion device for achieving substantially immediate hemostasis at the puncture site of the blood vessel wall, comprising an intravascular anchor having one or more suture attachment points, an extracorporeal cap having a lumen, a sealant having a lumen, and a suture connected to at least one of the one or more suture attachment points of the intravascular anchor and passed through the lumen of the extracorporeal cap and the lumen of the sealant to connect the intravascular anchor to the extracorporeal cap and the sealant, the suture having a proximal suture portion and a distal suture portion, the distal suture portion having a diameter larger than the diameter of the lumen of the extracorporeal cap, the distal suture portion forming an interference fit for locking the extracorporeal cap onto the puncture site, and the intravascular anchor, the extracorporeal cap, the sealant, and the suture being formed of a bioabsorbable material.

[0218] Embodiment 11. The vascular occlusion device according to any one of Embodiments 10, wherein the extracorporeal cap is formed of a flexible material.

[0219] Embodiment 12. The vascular occlusion device according to any one of Embodiments 10 to 11, wherein the suture is a braided suture.

[0220] Embodiment 13. The vascular occlusion device according to any one of Embodiments 10 to 12, wherein the sealant is screwed onto the suture at a proximal position of the extracorporeal cap.

[0221] Embodiment 14. The vascular occlusion device according to any one of Embodiments 10 to 13, wherein the sealant locks the extracorporeal cap in place and coagulates the access path at the puncture site to provide substantially immediate hemostasis when activated.

[0222] Embodiment 15. The vascular occlusion device according to any one of Embodiments 10 to 14, wherein the intravascular anchor comprises an elongated body having a flexible member.

[0223] Embodiment 16. A vascular closure device according to any one of Embodiments 10 to 15, wherein the intravascular anchor is located on the central axis of an elongated body and has a raised keel that extends along the length of the elongated body.

[0224] Embodiment 17. A vascular closure device according to any one of Embodiments 10 to 16, wherein the raised keel has one or more suture attachment points.

[0225] Embodiment 18. A vascular occlusion device according to any one of Embodiments 10 to 17, wherein the sealant comprises polyethylene glycol (PEG).

[0226] Embodiment 19. An intravascular anchor for a vascular occlusion device for achieving substantially immediate hemostasis at a puncture site in the wall of a blood vessel, comprising: an elongated body including a flexible member for conforming to the wall of a blood vessel; and a keel having one or more suture attachment points, wherein the keel has an elongated member centrally positioned along the central axis of the elongated body.

[0227] Embodiment 20. The intravascular anchor according to claim 19, wherein the elongated body includes a plurality of ribs extending radially from the keel to a raised edge forming the outer circumference of the elongated body.

[0228] Embodiment 21. A delivery system for realizing a vascular occlusive device to provide substantially immediate hemostasis to a puncture site in the wall of a blood vessel, comprising: a handle assembly having a body having a proximal end, a distal end, a lumen extending from the proximal end to the distal end, a first actuator, and an elongated opening configured to provide a path for the first actuator; an implant assembly located within the lumen of the body having a vascular occlusive device, a slider, and a chamber, wherein the slider of the implant assembly is configured to be engageable with the first actuator; an interlock mechanism configured to selectively disengage the delivery system from the vascular occlusive device when the vascular occlusive device is delivered to a puncture site in the wall of a blood vessel, comprising: a handle assembly; and a delivery sheath configured to selectively connect to the distal end of the handle assembly, wherein the vascular occlusive device is delivered through the delivery sheath to a puncture site in the wall of a blood vessel and configured to be fixed around the puncture site, thereby providing substantially immediate hemostasis.

[0229] Embodiment 22. The delivery system according to Embodiment 21, wherein the interlock mechanism comprises a first latch, a second latch connected to the first latch via a latch pin, a bolt for securing at least a portion of the proximal suture portion of the suture of the vascular occlusion device, and a slider mechanically communicating with the bolt, the slider being configured to release at least a portion of the proximal suture portion of the suture, and when at least a portion of the proximal suture portion of the suture is released, the delivery system is disengaged from the vascular occlusion device.

[0230] The present invention may be embodied in other specific forms without departing from its spirit or essential features. The embodiments described should be considered in all respects to be illustrative and not limiting. Accordingly, the scope of the present invention is indicated not by the above description but by the appended claims. All modifications that fall within the meaning and scope of the Equivalents of the claims should be encompassed within those scopes. Although the present invention has been described in relation to vascular closure, it should be further understood that the closure components of the present invention may be used to close other openings in the body, such as PFO openings, or openings formed in organs such as the stomach for certain surgical procedures.

Claims

1. A vascular occlusion device for achieving virtually immediate hemostasis at the puncture site of the blood vessel wall, An intravascular anchor having one or more suture attachment points, An extravascular cap having a lumen, sealant and, A suture connected to at least one of one or more suture attachment points of an intravascular anchor, connecting the intravascular anchor to the extravascular cap and sealant through the lumen and sealant of the extravascular cap, Equipped with, The intravascular anchors, extravascular caps, sealants, and sutures are each formed from bioabsorbable materials. Closure device.

2. The vascular closure device according to claim 1, wherein the intravascular anchor comprises an elongated body having a flexible member and a keel.

3. The vascular closure device according to claim 1, wherein the extravascular cap is formed of an elastomer material.

4. The vascular occlusion device according to claim 1, wherein the sealant comprises polyethylene glycol (PEG).

5. The vascular closure device according to claim 1, wherein the suture has a distal suture portion and a proximal suture portion.

6. The vascular closure device according to claim 5, wherein the diameter of the lumen of the extravascular cap is smaller than the diameter of the distal suture portion.

7. The vascular closure device according to claim 1, wherein the intravascular anchor comprises a bioabsorbable material.

8. The vascular closure device according to claim 1, wherein the intravascular anchor has multiple ribs that radiate from the keel to the raised edge of the elongated body.

9. The vascular occlusion device according to claim 1, wherein the sealant can expand up to four times its original size when introduced into a fluid.

10. A vascular occlusion device for achieving virtually immediate hemostasis at the puncture site of the blood vessel wall, An intravascular anchor having one or more suture attachment points, An extravascular cap having a lumen, A sealant having a lumen, A suture connected to at least one of one or more suture attachment points of an intravascular anchor, which is screwed through the lumen of the extravascular cap and the lumen of the sealant to connect the intravascular anchor to the extravascular cap and sealant, Equipped with, The suture has a proximal suture and a distal suture, with the distal suture having a diameter larger than the diameter of the lumen of the extravascular cap. The distal suture forms a crimp to secure the extravascular cap over the puncture site. Intravascular anchors, extravascular caps, sealants, and sutures are made from bioabsorbable materials. Closure device.

11. The vascular closure device according to claim 10, wherein the extravascular cap is formed of a flexible material.

12. The vascular occlusion device according to claim 11, wherein the sealant, when activated, locks the extravascular cap in place, coagulates the access route at the puncture site, and provides substantially immediate hemostasis.

13. The vascular closure device according to claim 10, wherein the suture is a braided suture.

14. The vascular closure device according to claim 10, wherein the sealant is screwed onto the suture at a position proximal to the extravascular cap.

15. The vascular closure device according to claim 10, wherein the intravascular anchor comprises an elongated body having a flexible member.

16. The vascular closure device according to claim 15, wherein the intravascular anchor is located on the central axis of the elongated body and has a raised keel extending along the length of the elongated body.

17. The vascular closure device according to claim 16, wherein the raised keel has one or more suture attachment points.

18. The closure device according to claim 10, wherein the sealant comprises polyethylene glycol (PEG).

19. An intravascular anchor for a vascular occlusion device that achieves substantially immediate hemostasis at the puncture site of a blood vessel wall, A long, slender body having a flexible membrane to conform to the wall of a blood vessel, A keel having one or more suture attachment points, Equipped with, The keel is a long, slender component positioned in the center along the central axis of the elongated body. Intravascular anchors contain bioabsorbable materials. Intravascular anchors.

20. The intravascular anchor according to claim 19, wherein the elongated body has a plurality of ribs extending radially from the keel to a raised edge forming the periphery of the elongated body.

21. A delivery system for realizing a vascular occlusion device to provide substantially immediate hemostasis at the puncture site in the wall of a blood vessel, A handle assembly, A body having a proximal end, a distal end, a lumen extending from the proximal end to the distal end, a first actuator, and an elongated opening configured to provide a path for the first actuator, An implant assembly located within the lumen of a main body, comprising the vascular occlusion device described in claim 10, a slider, and a chamber, wherein the slider of the implant assembly is configured to be engageable with a first actuator, When the vascular occlusion device is delivered to the puncture site in the blood vessel wall, an interlock mechanism is configured to selectively disengage the delivery system from the vascular occlusion device, A handle assembly comprising, A delivery sheath configured to be selectively connected to the distal end of the handle assembly, It has, The vascular occlusion device is configured to be delivered to the puncture site in the wall of a blood vessel through a delivery sheath and to be fixed around the puncture site, thereby providing substantially immediate hemostasis. Delivery system.

22. The interlock mechanism The first latch and, A second latch connected to a first latch via a latch pin, A bolt for securing at least a portion of the proximal suture portion of the suture of a vascular occlusion device, The device comprises a bolt and a slider that is mechanically in communication with the bolt, the slider being configured to release at least a portion of the proximal suture portion of the suture, and when at least a portion of the proximal suture portion of the suture is released, the delivery system is disengaged from the vascular occlusion device. The delivery system according to claim 21.

Images