Vascular Closure Devices

Abstract

To provide a device to be used to close an opening of a blood vessel.SOLUTION: A vascular closure device includes: a self-expanding blood vessel sealing element 12; a holding element which encircles the blood vessel sealing element 12 and is configured to hold the blood vessel sealing element in a lumen of a holding element 14 with a structure that the blood vessel sealing element does not completely self-expand; and a tether which passes the lumen of the holding element and is configured to destruct the holding element so that the blood vessel sealing element freely expands when a first force greater than a threshold force is applied to a tether 16. The current invention relates to a system for delivering such a vascular closure device and a method for closing a vascular access hole 15 by using a corresponding device.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] The present invention relates to devices used to close openings in blood vessels (i.e., vascular closure devices). The present invention further relates to systems for deploying such vascular closure devices and methods of closing openings in blood vessels using such devices. [Background technology]

[0002] During endovascular procedures, surgeons typically enter a patient's vascular system through a vascular access hole that establishes a connection between the lumen of the patient's blood vessel and the surroundings. Through this vascular access hole, devices such as catheters are introduced into the vascular system and advanced to the treatment site.

[0003] After the procedure is completed, the device introduced into the vascular system is withdrawn, but the vascular access hole remains. This vascular access hole needs to be closed to stop bleeding. To close the vascular access hole, prior art documents such as U.S. Pat. No. 9,375,215 report that a vascular stent graft is placed inside the blood vessel and pressed against the vascular access hole, thereby closing the vascular access hole from the inside.

[0004] However, it should be noted that the technology can also be used in applications outside the operating room, for example, in the treatment of road or battlefield accidents where urgent bleeding control is required in critical situations. Summary of the Invention [Problem to be solved by the invention]

[0005] It has been recognized that there is still a need for improvement in prior art vascular closure devices. In particular, it has been found that hematomas greater than 5 cm in diameter, pseudoaneurysms, arteriovenous fistulas, access site-related bleeding, acute ipsilateral limb ischemia, and other complications sometimes occur, which are undesirable and may require further surgical / interventional treatment. It has also been found that there is a need to minimize the risk of causing local infection. The inventors have further recognized a need to simplify the structure of vascular closure devices.

[0006] The present invention aims to alleviate or overcome at least some of the problems mentioned above. [Means for solving the problem]

[0007] The invention is defined by independent claims 1, 10 and 11. Optional features are defined in the respective dependent claims. According to claim 1, the vascular closure device comprises a self-expanding tubular vascular closure element. Such a self-expanding tubular vascular closure element can take the form of, for example, a stent at least partially covered by a cover configured to be pressed against a vascular access hole to close the hole. This pressing then serves to close and thus seal the vascular access hole from the inside. Generally speaking, the vascular closure element can be any tubular-shaped element having a wall sufficiently impermeable to seal the vascular access hole against blood leakage. By the vascular closure element being self-expanding, we mean that the vascular closure element expands by itself when heated to a temperature on the order of human body temperature, without the need for, for example, an inflatable balloon or other type of external means for expanding it. This expansion force presses the cover of the vascular closure element against the vascular access hole, closing it. Furthermore, this expansion force secures the vascular closure element within the patient's blood vessel, thereby preventing it from migrating, similar to the way a typical stent or stent-graft is secured within a blood vessel by pressing against the vessel wall.

[0008] Further, in embodiments, a retention element is provided that can have the form of a tube made of a single layer. In embodiments, the tube has a circular cross section. The retention element surrounds the vascular closure element when the vascular closure element is disposed within the lumen of the retention element, and holds the vascular closure element in a configuration in which the vascular closure element is not fully self-expanded. That is, the retention element restrains the vascular closure element and holds the vascular closure element in a configuration in which the vascular closure element is not fully self-expanded. This restraining function also functions while the assembly of the vascular closure element and retention element is inserted into the patient's vascular system. That is, the retention force of the retention element is strong enough to prevent self-expansion of the vascular closure element while the retention element is disposed to surround the vascular closure element.

[0009] Additionally, a tether is provided. The tether is arranged such that upon application of a first force greater than a threshold force to the tether, the retention element collapses to the extent that the vascular closure element can freely expand. In other words, in such a configuration, the retention element no longer retains the vascular closure element in an unexpanded configuration. In this context, the term "collapse" means that the retention element loses its shape to the extent that it is no longer able to retain the vascular closure element in an unexpanded configuration. For example, if the vascular closure element is a tube made from a single sheet rolled into a tubular shape, this may mean that the tube splits longitudinally. If the tube is made from a fabric made from one or more woven / braided yarns, "collapse" means that the yarns rearrange to the extent that they no longer constitute a fabric capable of restraining the vascular closure element. In embodiments, this rearrangement may mean that the yarns completely unravel, but it should be noted that complete unraveling is not required.

[0010] The use of a vascular closure device configured in this manner allows for a simplified structure. In particular, compared to prior art devices such as those of U.S. Patent No. 9,375,215, it is possible to use much simpler retention elements, which can have the form of simple tubes. Because a tether is used to collapse the retention elements, it is not necessary to provide the other rather complex structure shown in U.S. Patent No. 9,375,215, in which a thread is threaded through a series of pre-made openings. Therefore, the corresponding vascular closure device is easier to manufacture.

[0011] As noted above, the tether serves two functions. When a force below a threshold force is applied to the tether, the tether does not collapse the retention element. Thus, if a sufficiently small force is applied, the vascular closure element is moved. Only when a second, larger force above the threshold force is applied does the tether collapse the retention element. Thus, the tether has the dual purpose of acting as a positioning element for assembly of the retention element and vascular closure element for a sufficiently small force, and as a collapse unit for a larger force to collapse the retention element, thereby allowing (further) expansion of the vascular closure element.

[0012] In some embodiments, a tether is threaded through the lumen of the retention element, and in further embodiments, it extends between the vascular closure element and the retention element. The tether is configured to sever the retention element upon application of a first force greater than a threshold force to the tether, allowing the vascular closure element to freely self-expand. That is, when the vascular closure element is held in place (e.g., by being pulled against the wall of a blood vessel), if a sufficiently strong force is applied to the tether, the tether severs the retention element, thereby allowing the vascular closure element to self-expand. On the other hand, if the force is less than the threshold force, the tether does not sever the retention element, but instead moves the assembly of the retention element and the vascular closure element. Such a system is easy to implement, as collapse of the retention element is achieved by a relatively simple cutting action.

[0013] In embodiments, the tether is configured to extend from a first longitudinal end of the retention element to an opposite second longitudinal end of the retention element. "Longitudinal" means in the axial direction of the retention element (i.e., if the retention element is typically tubular, the axis of the tube). Both ends of the tether are positioned outside the assembly of the vascular closure element and the retention element. Because both ends of the tether are positioned outside the assembly of the vascular closure element and the retention element, and in embodiments, the ends of the tether are positioned at opposite longitudinal ends of the retention element, simultaneous pulling on both ends of the tether allows for easy centering of the retention element and the vascular closure element. When both ends of the tether are guided through the vascular access hole, this centers the retention element at the vascular access hole.

[0014] When the vascular closure element is positioned such that the portion of the vascular closure element operable to close the vascular access hole is positioned so that it is covered by the retention element, this allows the vascular closure element to be positioned so that it closes the vascular access hole. Thus, the vascular closure device is particularly easy to use, as it is relatively easy to position the vascular closure element simply by exerting a pulling force on both ends of the tether.

[0015] In that context, in embodiments, the ends of the tether are connected together so that the tether forms a loop. Because they are connected together, it is particularly easy to apply tension, i.e., by simply pulling on the looped tether. As noted above, this allows for easy positioning of the vascular closure element.

[0016] In embodiments, a pull-out tether is further provided that is coupled to the retention element and configured such that, once the retention element is severed, e.g., by applying a sufficiently large force to the tether, the retention element can be easily withdrawn from the patient's vasculature by using the pull-out tether to pull it through the vascular access hole, making the corresponding vascular closure device particularly user-friendly.

[0017] In an embodiment, the retention element is made from PET (polyethylene terephthalate). Such a material is well characterized and found to be widely used in intravascular surgery. Furthermore, with PET, application of a sufficiently large force to the tether leads to crack propagation through the PET sleeve, improving cutting behavior.

[0018] In another embodiment, the retention element comprises a knitted sleeve disposed to surround the vascular closure element. The tether is coupled to the knitted sleeve such that upon application of a first force greater than a threshold force, the knitted sleeve collapses to allow the vascular closure element to expand. The tether is thus coupled to a loop of knitted fabric in the sleeve. The knit is such that the fabric collapses when the tether is pulled. In this configuration, the number of parts can be reduced because the tether and retention element are made from the same yarn.

[0019] In that context, in a further embodiment, the knitted sleeve comprises yarns made from UHMWPE (ultra-high molecular weight polyethylene), such as Dyneema™. As such, because the fabric is knitted from yarns made from UHMWPE, the knitted fabric is particularly suitable for use in surgery.

[0020] In embodiments, the vascular closure element comprises a stent graft. The stent graft may be covered by a covering material along the entire base stent, although it is sufficient for the base stent to be only partially covered. That is, the stent graft does not necessarily have to be covered along its entire length, but in embodiments may be covered only along a portion of its longitudinal and / or circumferential extent. Such stent grafts are well characterized and widely used in endovascular procedures, which means that by applying expertise in the manufacture of such devices, reliable vascular closure devices can be manufactured. In embodiments, the base stent may have a sufficiently coarse mesh so that it can be penetrated after deployment using a syringe or other type of medical and / or surgical device, if desired. Covering materials for stent grafts include: Therefore, it is possible to use ePTFE.

[0021] In embodiments, the vascular closure element comprises a bioabsorbable material. A bioabsorbable material is a material that dissolves after a period of time after being provided within a patient's vascular system. An example of such a bioabsorbable material is polylactic acid (PLLA). Another type of material that can be used is magnesium, which can be in the form of a web or foil. In embodiments, the bioabsorbable material is configured as a patch on the surface of the vascular closure element at the location where the vascular closure element will be used to close the vascular access hole. By having the vascular closure element made from a bioabsorbable material, the vascular closure element dissolves over time, typically over the course of several days to several weeks. During that time frame, the vascular access hole is typically closed by the body's natural healing process, reducing the cross-section of the vascular closure device and therefore its impact on the vessel in which it is implanted. In further embodiments, substantially the entire vascular closure element is made from a bioabsorbable material (i.e., the meshwork of the base stent as well as the material designed for wound closure). In this regard, PLLA is particularly useful because it is bioabsorbable and can be used to manufacture self-expanding stents.

[0022] In some embodiments, the tether is positioned between the first and second longitudinal ends of the retention element so that the tether extends entirely inside the retention element. That is, the tether is not threaded through the retention element so that it extends partially inside and partially outside the retention element. Such a vascular closure device is easier to manufacture.

[0023] In an embodiment, the tether is disposed between the retaining element and a portion of the vascular closure element suitable for closing (sealing) the vascular access hole, thereby allowing for particularly easy positioning of the vascular closure device relative to the vascular access hole.

[0024] According to another aspect of the present invention, there is provided a system for delivering the aforementioned vascular closure device. The system includes a catheter for introduction into a patient's blood vessel. The catheter is configured so that the vascular closure device can be delivered into the patient's blood vessel by first introducing a catheter sheath into the blood vessel (e.g., through a vascular access hole) and then advancing the vascular closure device through the sheath. The assembly of the vascular closure element and the retention element is disposed at the distal end of the catheter for easy deployment.

[0025] According to another aspect of the present invention, a method for closing a vascular access hole in a blood vessel is provided. The method includes deploying a vascular closure device as described above into a patient's vasculature through a vascular access hole so that a tether extends through the vascular access hole and out of the patient's body. A first tensile force less than a threshold force is then applied to the tether. This serves to pull the assembly of the vascular closure element and retention element against the vessel wall adjacent the vascular access hole so as to position the portion of the vascular closure element intended to seal the vascular access hole relative to the hole. After this step, a second tensile force greater than the threshold force is applied to the tether. This application of force causes the tether to collapse the retention element. Once the retention element collapses, the vascular closure element is released from the retention element and can then self-expand. During this self-expansion step, the vascular closure element presses against the wall of the blood vessel containing the vascular access hole, thereby sealing the vascular access hole. The vascular access hole is therefore sealed. Such a method is easy for surgeons to perform and, in particular, in embodiments, reduces the amount of tension the tether needs to be applied compared to U.S. Patent No. 9,375,215.

[0026] In embodiments, the method further comprises withdrawing the tether from the patient's body, which method prevents the tether from unnecessarily interfering with the patient's body. In a further embodiment, the method further comprises removing the collapsed retention element from the patient's body. This prevents the collapsed retention element from interfering with the patient's body. [Brief explanation of the drawings]

[0027] [Figure 1] 1A-1C illustrate a system for delivering a vascular closure device according to one embodiment in a delivery configuration. [Figure 2] FIG. 2 shows the system according to FIG. 1 and the view in which the catheter is in the process of being withdrawn. [Figure 3] 3A and 3B show a further step in the deployment of the vascular closure elements of the system according to FIGS. 1 and 2. [Figure 4] 3A and 3B show a further step in the deployment of the vascular closure elements of the system according to FIGS. 1 and 2. [Figure 5] FIG. 10 shows the vascular closure element fully deployed. DETAILED DESCRIPTION OF THE INVENTION

[0028] FIG. 1 shows, in subfigure a), a vascular closure device 10 during a first stage of deployment in a blood vessel 22. A catheter 20 is placed in the blood vessel 22, connecting the blood vessel 22 to the outside of the patient's body and having a vascular access hole 15 that may be created during a procedure, such as an endovascular procedure. The blood vessel 22 may be, for example, the femoral artery. The catheter 20 includes a sheath (introducer / guide sheath) 25 that extends into the blood vessel 22 through the vascular access hole 15. The distal end of the sheath 25 is located inside the blood vessel 22, and the proximal end is located outside the blood vessel and includes a gate 24 for selective introduction and removal of components into and out of the sheath 25. In this context, the term "proximal" refers to the direction along the sheath 25 toward the surgeon, and "distal" refers to the opposite direction, away from the surgeon.

[0029] As can be seen in Figure 1, a vascular closure device 10 is positioned inside a blood vessel 22. The vascular closure device 10 includes a vascular closure element (stent graft) 12, shown in more detail in Figure 1b. A tubular retention element 14 made from a single-layer PET sheath is wrapped around the vascular closure element 12 to retain the vascular closure element 12 in a non-fully expanded configuration. In that configuration, the assembly of the vascular closure element 12 and the sheath-form retention element 14 can be placed within the lumen of a sheath 25, which is the delivery configuration of the vascular closure device 10 (not shown).

[0030] Also shown is a pusher wire 11 extending through the lumen of the vascular closure element 12 and through the lumen of the sheath 25. Proximal to the stent graft 12 is a pusher cone 28 sized to enable the vascular closure element 12 to be pushed out of the lumen of the sheath 25. Such a pusher wire 11 may be made of nitinol and, in embodiments, may have a thickness of 0.02 inches to 0.035 inches. The pusher wire 11 enables the vascular closure element 12 to be pushed out of the lumen of the sheath 25 during deployment.

[0031] The tether 16, which may be made of a metal wire, extends through the sheath 25 and is sandwiched between the vascular closure element 12 and the retention element 14. The tether 16 may also be referred to as a looped split tether. The ends of the tether 16, which may also be referred to as a looped split wire in some embodiments, are guided through the lumen of the sheath 25 to a position beyond the proximal end of the sheath 25, where they are joined together. A pull ring 30 is positioned so that the tether 16 can slide freely through it. The pull ring 30 may be used to apply tension to the tether 16. It should be noted that the pull ring 30 is entirely optional and need not be present. It should also be noted that the pull ring 30 need not have a circular shape. By pulling the tether 16, the vascular closure element 12 can be pulled adjacent to the vascular access hole 15, as described in more detail below. The holding element 14 can be positioned in the holding element 14 and can be released from the holding element 14. Details of this positioning and release will be explained later with reference to Figures 2 to 5.

[0032] Additionally, a pull-out tether 18, which may also be referred to as a split sheath removal line, is provided. The pull-out tether 18 is connected to the retention element 14 and is routed within the sheath 25 such that the pull-out tether 18 extends beyond the proximal end of the sheath 25. As will be explained more fully when describing subsequent figures, the pull-out tether 18 may be used to remove the severed retention element 14 from the patient's vasculature.

[0033] FIG. 1b shows the structure of the vascular closure element (vascular plug) 12 in more detail. As can be seen from the drawing, in an embodiment, a base stent 13 is provided, onto which a patch 19, which may be made of polylactic acid (PLLA), is placed. However, as previously mentioned, other materials can also be used. The base stent 13 itself is made of a self-expanding material. In an embodiment, Nitinol was used for the base stent 13, which was cut using femto-laser technology for selective material ablation. In an embodiment, the base stent 13 had an expanded diameter of approximately 9-12 mm and was circumferentially half-covered with a PLLA patch 19 having a length of approximately 10 mm. Such a length has been found to cover a femoral artery access site with a large margin of safety.

[0034] In the embodiment currently shown in FIG. 1 a), tether 18 is looped between PLLA patch 19 and retaining element 14. This allows for more precise positioning of patch 19 adjacent vascular access hole 15, as pulling tether 18 automatically positions patch 19 adjacent vascular access hole 15.

[0035] In an embodiment, a catheter with an outer diameter of 5F was used as the sheath 25. An exemplary system was the Halo 1 catheter sheath provided by Becton Dickinson and Company, which has an inner diameter of 4F.

[0036] While FIG. 1a) shows a configuration in which the vascular closure element 12 and retention element 14 assembly has just been pushed out of the distal end of the catheter 20, FIG. 2 shows a configuration that occurs slightly later during deployment of the vascular closure element 12. As can be seen in FIG. 2, the sheath 25 has been substantially withdrawn from the blood vessel 22 while still promoting hemostasis. The sheath 25 still extends through the vascular access hole 15, but in the configuration shown in FIG. 1a), it extends much less into the blood vessel 22. In the configuration shown in FIG. 2, the vascular closure element 12 is still constrained by the retention element 14 such that its cross-sectional diameter is significantly smaller than the diameter of the blood vessel 22. Thus, the vascular closure element 12 is free to move within the blood vessel 22 and can therefore be repositioned within the blood vessel 22 by applying a tension force to the tether 16.

[0037] 3 shows the next step in the deployment of vascular closure element 12. As can be seen in that figure, tether 16 extends from the distal end of sheath 25 and is sandwiched between vascular closure element 12 (more precisely, PLLA patch 19) and retention element 14. However, as can be seen in that figure, pusher wire 11 has been withdrawn from blood vessel 22.

[0038] Now, when a pulling force is applied to the pull ring 30, the tether 16 is pulled through the sheath 25, transitioning the system from the configuration shown in Figure 3 to the configuration shown in Figure 4. Because the force applied to the tether 16 is symmetrical, the vascular closure element 12 becomes positioned so that the vascular closure element 12 is centered in the vascular access hole 15. Thus, because the tether 16 is sandwiched between the retention element 14 and the patch 19, the patch 19 is positioned adjacent to the vascular access hole 15, thus closing the vascular access hole 15 from the inside. 4, in that configuration, vascular closure element 12 is still too small in diameter to be fixed in position relative to blood vessel 22 by the presence of retention element 14. That is, without tether 16 (as well as pull-out tether 18), the assembly of vascular closure element 12 and retention element 14 would move freely within blood vessel 22, which is undesirable if one wishes to close vascular access hole 15.

[0039] 4 is reached, the surgeon applies a stronger pulling force to tether 16. This pulling force causes tether 16 to sever retention element 14 where it contacts retention element 14. Because tether 16 extends along the entire length of retention element 14, tether 16 severs the entire length of retention element 14. As a result, the severed retention element 14 no longer exerts a restraining force on the self-expansion of vascular closure element 12. The vascular closure element 12 then self-expands by being exposed to the patient's blood flow and thereby pressed against the wall of blood vessel 22. This causes vascular closure element 12 to press patch 19 against vascular access hole 15, thereby sealing it. The surgeon then uses tether 16 and the pull-out tether 18 to pull the severed remainder of retention element 14 out of the patient's body through sheath 25 of catheter 20.

[0040] In this way, the configuration shown in Figure 5 is achieved in which the vascular closure element 12 has fully self-expanded to press the patch 19 against the vascular access hole 15, which is shown as partially healed in the configuration shown in Figure 5. The closed vascular access hole 15 is then sealed from the inside to prevent blood leakage. Because the patch 19 is made of a bioabsorbable material, the patch 19 dissolves over time such that the cross section of the vascular closure element 12 decreases until it eventually has only the cross section of the base stent 13, thereby reducing its impact on blood flow through the blood vessel 22.

[0041] It should be noted that natural blood pressure also serves to press the patch 19 against the vascular access hole 15, thereby improving sealing and limiting bleeding. Furthermore, since there are no components extending outside the blood vessel 22 after deployment of the vascular closure element 12 and withdrawal of the tether 16 and pull-out tether 18, the risk of infection is reduced. Furthermore, having such a wound closure method is believed to reduce the risk of subcutaneous bleeding, as well as the development of hematomas and pseudoaneurysms. Furthermore, the lack of small parts and sealants that can become dislodged also reduces the risk of ipsilateral limb ischemia. As described above, the present invention has the following aspects. Form 1 A vascular closure device (10), comprising: - a self-expanding tubular vascular closure element (12); a retention element (14) surrounding the vascular closure element (12), the retention element (14) being configured to retain the vascular closure element (12) within the lumen of the retention element (14) when the vascular closure element (12) is in a fully unexpanded configuration; - a tether (16) configured to collapse the retention element (14) to such an extent that the vascular closure element (12) is free to expand upon application of a first force greater than a threshold force to the tether (16); and A vascular closure device (10). Form 2 A vascular closure device (10) according to aspect 1, A vascular closure device (10) in which the tether (16) is threaded through the inner lumen of the retention element (14), and the tether (16) is configured to sever the retention element (14) upon application of a first force greater than the threshold force to the tether, allowing the vascular closure element (12) to freely expand. Form 3 A vascular closure device (10) according to aspect 1 or 2, A vascular closure device (10) in which the tether (16) is configured to extend from a first longitudinal end of the retention element (14) to an opposite second longitudinal end of the retention element (14), and both ends of the tether (16) are positioned outside the assembly of the vascular closure element (12) and the retention element (14). Form 4 A vascular closure device (10) according to aspect 3, The ends of the tether (16) are connected together, forming a vascular closure device (10). Form 5 The vascular closure device (10) according to any one of aspects 1 to 4, The vascular closure device (10) further comprises a pull-out tether (18) coupled to the retention element (14) and configured to pull the retention element (14) out of the patient's vasculature when the retention element (14) is severed. Form 6 The vascular closure device (10) according to any one of aspects 1 to 5, A vascular closure device (10), wherein the retention element (14) is made from PET. Form 7 A vascular closure device (10) according to aspect 1, A vascular closure device (10), wherein the retention element (14) comprises a knitted sleeve arranged to surround the vascular closure element (12), and the tether (16) is coupled to the knitted sleeve such that upon application of the first force greater than the threshold force, the knitted sleeve collapses to allow the vascular closure element (12) to expand. Form 8 A vascular closure device according to aspect 7, A vascular closure device, wherein the knitted sleeve comprises yarns made from UHMWPE. Form 9 The vascular closure device (10) according to any one of aspects 1 to 8, A vascular closure device (10), wherein the vascular closure element (12) comprises a stent graft. Form 10 The vascular closure device (10) according to any one of aspects 1 to 9, A vascular closure device (10), wherein the vascular closure element (12) comprises a bioabsorbable material. Form 11 A vascular closure device (10) according to any one of aspects 1 to 6, 9 and 10, When the vascular closure device (10) has the features described in form 2, the tether (16) is positioned between the first longitudinal end and the second longitudinal end of the retention element (14) so ​​that the tether (16) extends throughout the inside of the retention element (14). Form 12 A vascular closure device (10) according to any one of aspects 1 to 6, 9, 10 and 11, When the vascular closure device (10) has the features described in form 2, the tether (16) is routed between a portion of the vascular closure element (12) suitable for sealing the vascular access hole (15) and the retaining element (14). Form 13 A system for delivering the vascular closure device (10) according to any one of aspects 1 to 12, comprising: - a catheter (20) for introduction into a patient's blood vessel; - A system comprising a vascular closure device (10) according to any one of aspects 1 to 12, wherein an assembly of the vascular closure element (12) and the retaining element (14) is disposed at the distal end of the catheter. Form 14 A method of closing a vascular access hole (15) in a blood vessel (22), comprising: - deploying the vascular closure device (10) of any one of aspects 1 to 12 into the patient's vascular system through the vascular access hole with the tether (16) extending outside the patient's body through the vascular access hole; - applying a first tension force below a threshold force to the tether (16) to pull the vascular closure element and retention element (14) assembly against a blood vessel wall adjacent the vascular access hole; - applying a second tensile force greater than the threshold force to the tether (16) to collapse the retention element (14), thereby releasing the vascular closure element (10) and allowing the vascular closure element to self-expand; A method comprising: Form 15 15. The method of claim 14, The method further includes withdrawing the tether (16) from the patient's body. Form 16 16. The method of claim 14 or 15, The method further comprises removing the collapsed retention element (14) from the patient's body.

Claims

1. A vascular closure device (10), comprising: a self-expanding tubular vascular closure element (12) comprising a patch for closing a vascular access hole (15); a retention element (14) surrounding the self-expanding tubular vascular closure element (12), the retention element (14) being configured to retain the self-expanding tubular vascular closure element (12) within the lumen of the retention element (14) when the self-expanding tubular vascular closure element (12) is in a fully unexpanded configuration; a tether (16) configured to collapse the retention element (14) to such an extent that the self-expanding tubular vascular closure element (12) is free to expand upon application of a first force to the tether (16) that is greater than a threshold force; a pull-out tether (18) coupled to said retention element (14) and configured to withdraw said retention element (14) from the patient's vasculature when said retention element (14) is severed; and Equipped with The tether (16) is threaded through the lumen of the retention element (14), and the tether (16) is configured to sever the retention element (14) upon application of a first force greater than the threshold force to the tether (16), allowing the self-expanding tubular vascular closure element (12) to freely expand. A vascular closure device (10).

2. A vascular closure device (10) according to claim 1, A vascular closure device (10) in which the tether (16) is configured to extend from a first longitudinal end of the retention element (14) to an opposite second longitudinal end of the retention element (14), and both ends of the tether (16) are positioned outside the assembly of the self-expanding tubular vascular closure element (12) and the retention element (14).

3. A vascular closure device (10), a self-expanding tubular vascular closure element (12) comprising a patch for closing a vascular access hole (15); a retention element (14) surrounding the self-expanding tubular vascular closure element (12), the retention element (14) being configured to retain the self-expanding tubular vascular closure element (12) within the lumen of the retention element (14) when the self-expanding tubular vascular closure element (12) is in a fully unexpanded configuration; a tether (16) configured to collapse the retention element (14) to such an extent that the self-expanding tubular vascular closure element (12) is free to expand upon application of a first force to the tether (16) that is greater than a threshold force; a pull-out tether (18) coupled to said retention element (14) and configured to withdraw said retention element (14) from the patient's vasculature when said retention element (14) is severed; and Equipped with the tether (16) is configured to extend from a first longitudinal end of the retention element (14) to an opposite second longitudinal end of the retention element (14), and both ends of the tether (16) are disposed outside the assembly of the self-expanding tubular vascular closure element (12) and the retention element (14); The two ends of the tether (16) are connected together, forming a vascular closure device (10).

4. A vascular closure device (10) according to any one of claims 1 to 3, A vascular closure device (10), wherein said retention element (14) is made from PET.

5. A vascular closure device (10), comprising: a self-expanding tubular vascular closure element (12) comprising a patch for closing a vascular access hole (15); a retention element (14) surrounding the self-expanding tubular vascular closure element (12), the retention element (14) being configured to retain the self-expanding tubular vascular closure element (12) within the lumen of the retention element (14) when the self-expanding tubular vascular closure element (12) is in a fully unexpanded configuration; a tether (16) configured to collapse the retention element (14) to such an extent that the self-expanding tubular vascular closure element (12) is free to expand upon application of a first force to the tether (16) that is greater than a threshold force; a pull-out tether (18) coupled to said retention element (14) and configured to withdraw said retention element (14) from the patient's vasculature when said retention element (14) is severed; and Equipped with The vascular closure device (10) includes a retaining element (14) that includes a knitted sleeve that is arranged to surround the self-expanding tubular vascular closure element (12), and the tether (16) is coupled to the knitted sleeve such that upon application of the first force that is greater than the threshold force, the knitted sleeve collapses to allow the self-expanding tubular vascular closure element (12) to expand.

6. The vascular closure device of claim 5, A vascular closure device, wherein the knitted sleeve comprises yarns made from UHMWPE.

7. A vascular closure device (10) according to any one of claims 1 to 6, A vascular closure device (10), wherein the self-expanding tubular vascular closure element (12) comprises a stent graft.

8. A vascular closure device (10) according to any one of claims 1 to 7, A vascular closure device (10), wherein the self-expanding tubular vascular closure element (12) comprises a bioabsorbable material.

9. A vascular closure device (10), comprising: a self-expanding tubular vascular closure element (12) comprising a patch for closing a vascular access hole (15); a retention element (14) surrounding the self-expanding tubular vascular closure element (12), the retention element (14) being configured to retain the self-expanding tubular vascular closure element (12) within the lumen of the retention element (14) when the self-expanding tubular vascular closure element (12) is in a fully unexpanded configuration; a tether (16) configured to collapse the retention element (14) to such an extent that the self-expanding tubular vascular closure element (12) is free to expand upon application of a first force to the tether (16) that is greater than a threshold force; a pull-out tether (18) coupled to said retention element (14) and configured to withdraw said retention element (14) from the patient's vasculature when said retention element (14) is severed; and Equipped with the tether (16) is threaded through the lumen of the retention element (14), and the tether (16) is configured to sever the retention element (14) upon application of a first force greater than the threshold force to the tether (16) so as to allow the self-expanding tubular vascular closure element (12) to freely expand; A vascular closure device (10) in which the tether (16) is positioned between a first longitudinal end and a second longitudinal end of the retention element (14) so ​​that the tether (16) extends entirely inside the retention element (14).

10. A vascular closure device (10), comprising: a self-expanding tubular vascular closure element (12) comprising a patch for closing a vascular access hole (15); a retention element (14) surrounding the self-expanding tubular vascular closure element (12), the retention element (14) being configured to retain the self-expanding tubular vascular closure element (12) within the lumen of the retention element (14) when the self-expanding tubular vascular closure element (12) is in a fully unexpanded configuration; a tether (16) configured to collapse the retention element (14) to such an extent that the self-expanding tubular vascular closure element (12) is free to expand upon application of a first force to the tether (16) that is greater than a threshold force; a pull-out tether (18) coupled to said retention element (14) and configured to withdraw said retention element (14) from the patient's vasculature when said retention element (14) is severed; and Equipped with the tether (16) is threaded through the lumen of the retention element (14), and the tether (16) is configured to sever the retention element (14) upon application of a first force greater than the threshold force to the tether (16) so as to allow the self-expanding tubular vascular closure element (12) to freely expand; A vascular closure device (10), wherein the tether (16) is routed between the retaining element (14) and a portion of the self-expanding tubular vascular closure element (12) suitable for sealing the vascular access hole (15).

11. A system for delivering a vascular closure device (10) according to any one of claims 1 to 10, comprising: a catheter (20) for introduction into the patient's blood vessel; - a vascular closure device (10) according to any one of claims 1 to 10, wherein the assembly of the self-expanding tubular vascular closure element (12) and the retaining element (14) is arranged at the distal end of the catheter (20).

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