Closure system for closing arteriotomy in vessel wall

Abstract

To provide a closure system for delivering a sealant to an arteriotomy.SOLUTION: A distal section of a closure system 20 can include overlapping inner and outer sleeves that can expand with expansion of a sealant 18. A proximal section of the closure system can include a handle portion 30 and a sheath adapter 40 extending from the handle portion. The handle portion can comprise one or more actuators 32, 34, 36 that when depressed or engaged can assist in deployment of the sealant in an arteriotomy and can further include tamping of the sealant and / or retraction of an expandable member. The sheath adapter can removably engage a side port 16 or an irrigation line 12 of a standard procedural sheath. When the sheath adapter is secured to the procedural sheath, movement of the closure system can also move the procedural sheath.SELECTED DRAWING: Figure 1C

Description

[Technical Field]

[0001] A percutaneous device and method for sealing a vascular puncture with a plug or sealant. [Background technology]

[0002] A hollow needle is inserted through the patient's skin into the vasculature to gain percutaneous access to the patient's vasculature. A guide wire can be passed through the needle lumen into the blood vessel, and After this, the needle can be removed. Then, the needle is inserted with or without one or more inflators. After the device, an introducer sheath can be advanced into the vessel over the guidewire. A catheter or other device is inserted through the medical sheath and along the guidewire to a location where a medical procedure will be performed. The device can be advanced. Once the procedure is complete, the device and introducer sheath are removed. This leaves a puncture extending between the skin and the vessel wall. To seal the puncture, the patient must wait until hemostasis occurs. External pressure can be applied to the overlying tissue, for example by hand and / or with a sandbag. .

[0003] Diagnostic or therapeutic procedures requiring access to the vasculature (e.g., imaging procedures, angioplasty) After completion of the procedure (surgery, stent delivery, etc.), the arteriotomy is closed by applying external pressure, clamping, suturing, etc. and / or deliver various mechanical or biological implants, such as metal implants, plugs or sealants. However, many of these closure procedures are time-consuming and require extensive repair. It is time-consuming, expensive, and uncomfortable for the patient, requiring the patient to spend long periods of time in the operating room, catheterization, and other procedures. These devices must remain fixed in the laboratory or holding area. Some prolonged closure procedures may increase the risk of hematoma due to bleeding before hemostasis. There is. Some closure procedures involve an introducer sheath and closure system used during a diagnostic or therapeutic procedure. This additional step may require a sheath exchange with a compatible sheath. This can be time-consuming and can increase the risk of vascular injury and infection. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, there remains a need for a closure method that eliminates the sheath exchange step. The disclosure is compatible with and incorporates standard procedural sheaths into sealant delivery methods. It is intended for closed systems where [Means for solving the problem]

[0005] Some aspects of the present disclosure are directed to methods and closure systems for sealing an arteriotomy. The closure system can be inserted through a standard procedural sheath and is Specifically, the device is configured to engage a side port or irrigation line of a procedural sheath. The sheath adapter may include a sheath adapter.

[0006] Inserting the closure system through an existing procedural sheath eliminates the need for a custom sheath. Includes the removal of the existing sheath and insertion of a custom sheath, as well as the insertion of a guidewire. Eliminates the steps associated with sheath exchange. Eliminating sheath exchange reduces arterial trauma and vascular injury. Reduces the risk of hematoma, maintains arterial access, saves time, and limits leakage and bleeding Minimize the chance of infection. A sheath may be provided within the closure system, which may include two sleeves, an inner sleeve and an outer sleeve. The sleeve may be configured.

[0007] In some embodiments, the method includes inserting a closure sheath through a procedure sheath extending through the arteriotomy. The method may also include attaching a sheath adapter to the stem. Releasably attaching the structure to a side port or irrigation line of a procedural sheath The sheath adapter of the closure system is secured to the treatment sheath by exposing the sealant. The hand is used to retract the treatment sheath and outer catheter relative to the inner catheter to allow the treatment sheath and outer catheter to be inserted. and retracting the support tube portion. The method may include tamping with a tamping member.

[0008] In some embodiments, the closure system includes a handle portion and a seal extending from the handle portion. The sheath adapter may include a releasable attachment to a treatment sheath. It may include mounting structure for mounting.

[0009] In some embodiments, the closure system includes an outer catheter extending from the handle portion. The outer catheter can include a proximal portion and a distal portion. The sleeve may include an inner sleeve and an outer sleeve surrounding the inner sleeve. The tube may include a first slit, and the outer sleeve may extend circumferentially from the first slit. The outer sleeve or primary sleeve may include a second slit offset therefrom. Retracts sleeve to reduce sleeve / sealant snagging and during sealant delivery The inner sleeve or secondary sleeve may be provided to reduce friction when the inner sleeve is inserted. The catheter tip should be provided to help insert the sealant when inserting the tip into the blood vessel. can be done.

[0010] Optionally, any of the above-described closure systems may include an inner catheter extending through an outer catheter. a support tube radially between the outer and inner catheters; and / or a sealant disposed on the distal portion of the outer catheter.

[0011] In some embodiments, the closure system unlocks the inner catheter relative to the handle. The handle may include a first actuator configured to A support tube or member may be inserted through the procedural sheath to aid in tamping the sealant. For example, the hand may include a second actuator configured to advance the hand. The actuator may include a cam drive mechanism, the cam being coupled to and supported by the second actuator. In some embodiments, the handle can be configured to move the supporting member. a third actuator configured to retract the expandable structure through the sealant; The third actuator may further comprise a third actuator adapted to move relative to the inner housing portion. It can be a retractable slider.

[0012] In another embodiment, the closure system can include a first actuator: The first actuator retracts the outer sleeve, thereby at least partially sealing the seal. The sealant is configured to selectively expose the arteriotomy and tamp the sealant toward the arteriotomy. A second actuator may be provided for retracting the expandable structure.

[0013] As used herein, structures that expose the seal, tamp the seal, and / or allow expansion At least one actuator or other type of controller that can retract the body. In another embodiment, a closure system is provided that includes a handle having a roller mechanism. The sealant can be exposed, the sealant tamped, and the expandable structure retracted. At least two actuators or other types of controller mechanisms, either alone or in combination A closure system is provided that includes a handle having any combination of these. In an embodiment, the sealant is exposed, then the sealant is tamped, and finally the expandable structure is At least three actuators or any other type of controller that can retract the A closure system is provided that includes a handle with a control mechanism.

[0014] Any feature, structure, or step disclosed herein may be combined with any other feature, structure, or step disclosed herein. Any feature, structure, or step may be substituted, combined, or omitted. Additionally, for purposes of summarizing the disclosure, certain aspects, advantages, and features of the device are described herein. It is understood that some or all of these advantages may not necessarily be realized in accordance with any particular implementation disclosed herein. It should be understood that no particular embodiment of the present disclosure is necessarily achieved according to the specific form. Not essential or required. [Brief explanation of the drawings]

[0015] [Figure 1A] 10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site. [Figure 1B] 10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site. [Figure 1C]10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site. [Figure 1D] 10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site. [Figure 1E] 10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site. [Figure 1F] 10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site. [Figure 1G] 10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site. [Figure 1H] 10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site. [Figure 1I] 10 illustrates a method of using an embodiment of the closure system to deliver a sealant to an arteriotomy site.

[0016] [Figure 2] FIG. 2B shows an enlarged view of the distal portion of the closure system shown in FIG. 1B through line 2-2.

[0017] [Figure 3] 3D shows an enlarged view of the sheath adapter of the closure system shown in FIG. 1C through line 3-3.

[0018] [Figure 4] 1A-1I illustrate another embodiment of a sheath adapter that can be used with the closure system shown in FIGS.

[0019] [Figure 5] 1A-1I illustrate another embodiment of a sheath adapter that can be used with the closure system shown in FIGS.

[0020] [Figure 6] 1A-1I illustrate another embodiment of a sheath adapter that can be used with the closure system shown in FIGS.

[0021] [Figure 7] 1A-1I illustrate another embodiment of a sheath adapter that can be used with the closure system shown in FIGS.

[0022] [Figure 8] 1A-1I illustrate another embodiment of a sheath adapter that can be used with the closure system shown in FIGS.

[0023] [Figure 9A] 10 illustrates a method of using a second embodiment of a closure system to deliver a sealant to an arteriotomy site. [Figure 9B] 10 illustrates a method of using a second embodiment of a closure system to deliver a sealant to an arteriotomy site. [Figure 9C] 10 illustrates a method of using a second embodiment of a closure system to deliver a sealant to an arteriotomy site. [Figure 9D] 10 illustrates a method of using a second embodiment of a closure system to deliver a sealant to an arteriotomy site. [Figure 9E] 10 illustrates a method of using a second embodiment of a closure system to deliver a sealant to an arteriotomy site. [Figure 9F] 10 illustrates a method of using a second embodiment of a closure system to deliver a sealant to an arteriotomy site. [Figure 9G] 10 illustrates a method of using a second embodiment of a closure system to deliver a sealant to an arteriotomy site.

[0024] [Figure 10A] FIG. 10 shows an enlarged view of the inside of a first actuator of the handle device shown in FIGS. 9A to 9G. [Figure 10B] FIG. 10 shows an enlarged view of the inside of a first actuator of the handle device shown in FIGS. 9A to 9G.

[0025] [Figure 10C] FIG. 10 shows an enlarged view of the distal end of the handle device shown in FIGS. 9A-9G.

[0026] [Figure 11A] 9A-9G show one embodiment of a visual indicator system for the handle shown in FIG. 9A-9G. [Figure 11B] 9A-9G show one embodiment of a visual indicator system for the handle shown in FIG. 9A-9G. [Figure 11C] 9A-9G show one embodiment of a visual indicator system for the handle shown in FIG. 9A-9G.

[0027] [Figure 12A] FIG. 10 shows an enlarged view of the inside of a second actuator of the handle device shown in FIGS. 9A to 9G. [Figure 12B] FIG. 10 shows an enlarged view of the inside of a second actuator of the handle device shown in FIGS. 9A to 9G.

[0028] [Figure 13A] FIG. 10 shows an enlarged view of the inside of a third actuator of the handle device shown in FIGS. 9A to 9G. [Figure 13B] FIG. 10 shows an enlarged view of the inside of a third actuator of the handle device shown in FIGS. 9A to 9G. [Figure 13C] FIG. 10 shows an enlarged view of the inside of a third actuator of the handle device shown in FIGS. 9A to 9G. [Figure 13D] FIG. 10 shows an enlarged view of the inside of a third actuator of the handle device shown in FIGS. 9A to 9G.

[0029] [Figure 14A] 10 illustrates a third embodiment of a closure system for delivering a sealant to an arteriotomy site.

[0030] [Figure 14B] 14B shows an internal view of the closure system of FIG. 14A.

[0031] [Figure 14C] 14B shows an enlarged view of the distal end of the handle device of FIG. 14A, further showing the tension indicator.

[0032] [Figure 15A]14B shows an internal view of the first actuator of the closure system of FIG. 14A. [Figure 15B] 14B shows an internal view of the first actuator of the closure system of FIG. 14A. [Figure 15C] 14B shows an internal view of the first actuator of the closure system of FIG. 14A. [Figure 15D] 14B shows an internal view of the first actuator of the closure system of FIG. 14A.

[0033] Various embodiments are shown in the accompanying drawings for purposes of illustration and in no way limit the scope of the embodiments. It should not be construed as limiting, nor should it be construed as limiting, to various features of different disclosed embodiments. These may be combined to form further embodiments that are part of this disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0034] A closure system for delivering a sealant to an arteriotomy and a method for sealing the arteriotomy are provided. The closure system can be attached to an existing procedural sheath. The present invention further includes a sheath adapter for the procedure sheath, so that the procedure sheath can be removed and replaced with another sheath. 1A-1I show a closure system 20. 1 illustrates a method for delivering a sealant 18 to an arteriotomy site 2 using a closure system 20. a first actuator, which can be used to control the function of the closure system 20; a handle portion having a first actuator 32, a second actuator 34, and a third actuator 36; The outer catheter 22 may include a handle portion 30. The outer catheter 22 may extend from the handle portion 30. The handle portion 30 can move axially with the handle portion 30. The distal portion of the handle portion 30 may include a sheath catch 40 or a sheath adapter. Cut.

[0035] The inner catheter 24 can extend through the outer catheter 22. The inner catheter 24 includes an expandable structure 26 disposed in a distal portion of the inner catheter 24. The inner catheter 24 can be, for example, connected to the outer catheter 22. and actuating the first actuator 32 to release the inner catheter 24. By retracting or advancing the third actuator 36 to move the The catheter 22 can move axially relative to the catheter 22. The examples provided herein are Although the expandable structure 26 is described as a balloon, the expandable structure may alternatively be Basket, Expandable Wire Braid, Expandable Mesh, Expandable Frame, Rotatable In another embodiment, the expandable structure can be, for example, For example, to provide tactile feedback to the user during the sealing procedure and / or to seal the puncture site. A bioabsorbable footplate or other element may be included at one end to provide a seal.

[0036] The sealant 18 is attached to the distal portion 60 of the outer catheter 22 and radially extends from the inner catheter. For example, the inner catheter 24 may be positioned between the outer catheter 22 and the inner catheter 24. 4 can extend through the sealant 18, while the outer catheter 22 removes the sealant 18. The sealant 18 is a 2012 patent entitled "Devices and Methods for Sealing a Vascular Puncture." U.S. patent application Ser. No. 10 / 199,494, filed Jan. 19, 2002, and incorporated herein by reference in its entirety. 3 / 354278, formed from freeze-dried hydrogels. a proximal or main first portion and a plurality of lyophilized and / or non-crosslinked precursors; For example, the first portion may be formed as a solid mass or plug and fused or otherwise attached to the first portion. and a distal or tip second portion (not shown) extending distally from the first portion. Further details regarding the composition of the present invention are provided in the "Devices and Methods for Sealing a Vascular Puncture" patent application Ser. No. 2005 / 0109999, entitled "Devices and Methods for Sealing a Vascular Puncture." No. 6,200,000, filed Nov. 5, 2004, and incorporated herein by reference in its entirety. This is described in specification No. 7335330.

[0037] The support tube 28 or support member is located proximal to the seal 18 and radially adjacent to the inner catheter. For example, the support member 28 may be disposed between the support 24 and the outer catheter 22. In this example, the inner catheter 24 extends through a support member 28 while the outer catheter 22 is supported by The support member 28 may be tubular so as to surround the inner cover. It includes a lumen extending between its proximal and distal ends for slidably receiving the catheter 24. The support member 28 supports the sealant 18 during positioning and prevents the sealant 18 from entering the artery. The sealant 18 can be tamped against the vessel wall V to close the incision 2. The support member 28 can be substantially rigid, semi-rigid, and / or substantially flexible, e.g. For example, proximal movement of the closure system relative to the seal 18 without buckling the support member 28 may be achieved. the distal end of the support member 28 to allow movement and / or compress the sealant 18 within the puncture. The support member 28 has sufficient column strength to allow the end to be advanced. For example, actuation of the second actuator 34 causes the outer catheter 24 to It can move axially relative to the side catheter 22 and the expandable structure. In this configuration, actuation of the second actuator 34 supports the inner catheter 24. The retaining member 28 can be released.

[0038] In combination with or in place of any of the features described herein, closure system 2 No. 6,250,490, filed September 25, 2013, and incorporated herein by reference in its entirety. Features of the sealant delivery device described in Patent Application No. 2014 / 0025103 It may include any of the following:

[0039] FIG. 1A shows a procedural sheath 10 extending through an arteriotomy 2. The procedural sheath 10 This can be the same sheath used during the transectomy and / or treatment procedure. Thus, the procedural sheath 10 may include a hub portion 14 having a side port 16. The side port 16 is connected to the irrigation line and / or the aspiration line 12. It can be fixed.

[0040] After the diagnostic and / or therapeutic procedure, the closure system 20 is inserted through the hub portion 14 and the outer catheter. The catheter 22 can be inserted through the procedural sheath 10 (FIG. 1). (See B). The outer catheter 22 is sized to fit a standard procedural sheath of 5F or larger. It can be made smaller.

[0041] The closure system 20 is configured such that the sheath adapter 40 engages with the hub portion 14 of the procedural sheath 10. The procedural sheath 10 can be advanced through the procedural sheath 10 until the procedural sheath 10 is fully extended (see FIG. 1C). As will be described in detail, the sheath adapter 40 is adapted to fit into the side port 16 or inlet of the hub portion 14. It can be designed to removably engage the ligation line 12 .

[0042] With the closure system 20 connected to the procedure sheath 10, the expandable inner catheter 24 The expandable structure 26 can be expanded using a syringe 50 (see FIG. 1D). The expandable structure 26 may have an expansion indicator to indicate that the expandable structure 26 has expanded to a predetermined pressure. For example, the inflation indicator 54 may be When the expandable structure 26 is fully expanded, it can be moved from a first position to a second position. As shown in FIG. 1D, in the second position, the inflation indicator 54 is positioned relative to the handle portion 30. The inflation indicator 54 may protrude from the proximal end of the handle portion 30. It may be located elsewhere, or any other suitable inflation indicator may be used. One alternative is to display a pressure reading and indicate full inflation of the balloon. The pressure gauge may include a dial with a needle indicator that can be adjusted to measure the pressure. After expanding the expandable structure 26, the inflation line 56 is closed by closing the valve 52. It can be sealed by this.

[0043] With the expandable structure 26 expanded, the closure system 20 and the procedure sheath 10 The expandable structure 26 can be retracted until it abuts the inner surface of the vessel wall V (FIG. 1E reference).

[0044] The inner catheter 24 is moved by actuating or depressing the first actuator 32. The inner catheter 24 is then released from the outer catheter 22. After this, the procedural sheath 10 and outer catheter 22 are removed from the inner cover to expose the sealant 18. The handle 24 can be retracted relative to the catheter 24 (see FIG. 1F). The sleeve portion 30 holds the outer catheter 22 in place while the inner catheter 24 remains in place. It can slide over the first actuator 32 to retract it.

[0045] With the sealant 18 exposed, the sealant 18 is tamped against the outer surface of the vessel wall V. As described above, the second actuator 3 4 acts to push the support member 4 against the inner catheter 24 and the outer catheter 22. 28 can be advanced.

[0046] After the sealant 18 is tamped, the expandable structure 26 may, for example, open the valve 52. and deflating the expandable structure 26 using a syringe 50. In the state where the expandable structure 26 is contracted, the expandable structure 26 activates or depresses the third actuator 36 to release the seal 18. The inner catheter 24 can be retracted through the outer catheter 22 and / or It can be retracted against the support member 28 (see FIG. 1I). After retraction of the occlusion structure 26, the sealant 18 is left in place against the vessel wall V. The stem 20 and the entire procedural sheath 10 can be removed from the body. 40 is connected to the treatment sheath 10, so that the closure system 20 and the treatment sheath 10 can be simultaneously The closure system 20 can be removed from the procedural sheath 10 and removed separately. It can also be removed.

[0047] 2 shows an expanded view of the closure system 20 prior to sealant delivery. As mentioned above, the sealant 18 The outer catheter 22 has a distal portion 60 radially extending from the inner catheter 24 to the outer catheter 22. The support member 28 can be disposed between the catheter 22 and the sealant 18. At least the distal portion 60 of the outer catheter 22 can be positioned within the outer sleeve. The outer sleeve 62 and the inner sleeve 64 may be included. Each of the four has at least one slit 62a, 64a (e.g., one slit The outer slit may include one slit, two slits, three slits, or more. The sleeve 62 and inner sleeve 64 may contain the same number of slits or different numbers of slits. The slits 62a and 64a are arranged so that the positions of the slits do not match each other. In one embodiment, the outer slit 62a is opposite the inner slit 64a. The inner and outer sleeves 62 may be positioned to the side (e.g., about 180 degrees apart). , 64 are the bodies through which the sealant 18 enters the outer catheter 22 through the slits 62a and 64a. The combination of inner and outer sleeves 62, 64 minimizes exposure to fluids. They can overlap so as to be surrounded in the circumferential direction.

[0048] In one embodiment, the outer sleeve 62 can be longer than the inner sleeve 64. The side sleeve 62 may be extended back to the handle portion 30 so as to be integral with the outer catheter, for example. The inner sleeve 64 can extend toward the outer periphery proximal to the slits 62a, 64a. The inner sleeve 64 and the outer sleeve 62 can be fixed to the side sleeve 62. It can be attached using thermal bonding, adhesive, mechanical bonding, or other suitable attachment methods. With the inner sleeve 64 positioned within the outer sleeve 62, the inner diameter of the distal portion 60 may be smaller than the inner diameter of the proximal portion of outer catheter 22.

[0049] In one example, the inner sleeve 64 is an outer sleeve that provides support to the outer sleeve 62. For example, the inner sleeve 64 and the outer sleeve 62 may be stiffer than the inner sleeve 64 and the outer sleeve 62. can have various thicknesses and / or be made of different materials. In one embodiment, the inner sleeve 64 is constructed from polyimide or a similarly rigid polymer. while the outer sleeve 62 can be made of a softer material such as polyamide. In another embodiment, the outer sleeve 62 can be made of Pebax ( Constructed from polyether block amides such as POLYETHER (PRODUCT NAME) or nylon materials. However, any other suitable material may be used for the inner and outer sleeves. In another embodiment, not shown, the outer sleeve 62 may be The tip may be thermoformed with a smaller radius at the distal end to provide an atraumatic tip for can.

[0050] The double layer sleeves 62, 64 are positioned such that the closure system 20 is retracted through the arteriotomy. The distal portion 60 may be configured to have a slit at the distal end 62 and a slit at the distal end 62. The lit design reduces friction during seal placement, reducing the risk of plugging the seal. For example, while the sealant 18 is still positioned within the closure system 20 (e.g., the distal When the sealant begins to expand (due to fluids entering from the end), the slit design of the distal portion 60 allows the sealant 1 8 provides space for the closure system 20 to expand without clogging.

[0051] 9A-9G show a second embodiment of a closure system 120. In this embodiment, the closure The tether system 120 is used to position the sealant, tamp the sealant, and secure the expandable structure. One or more actuators, specifically three actuators, that help to retract the The same features as those of the first embodiment shown and described in FIGS. 1A to 1I can be provided. have similar signs.

[0052] Similar to the function of the closure system 20 of FIG. 1B, the closure system 120 is configured to operate through the hub portion 14. the outer catheter 22 through the procedural sheath 10. (See FIG. 9A.) The outer catheter 22 is compatible with standard procedural sheaths of 5F or larger. It can be sized to fit the size.

[0053] The closure system 120 is configured such that the sheath adapter 40 engages the hub portion 14 of the treatment sheath 10. The procedural sheath 10 may be advanced through the procedural sheath 10 until the procedural sheath 10 is fully extended. Thus, the sheath adapter 40 is connected to the side port 16 or irrigation port of the hub portion 14. It can be designed to removably engage the line 12 .

[0054] As in the first embodiment described above, the inner catheter 24 is inserted through the outer catheter 22. The inner catheter 24 can be extended. It may also include an expandable structure 26, such as the balloon or other suitable element described above. The inner catheter 24 may be, for example, activating or depressing the first actuator 32 and the inner catheter 24 Activating or depressing the third actuator 36 to move the This allows for axial movement relative to the outer catheter 22. The closure system sheath is integrated into the device handle to provide compatibility with the placement sheath. This is done by forming an inner / outer sleeve assembly, e.g., two sleeves at the distal end. This can be achieved by providing an inner sleeve 64 and an outer sleeve 62 that This integral sheath, e.g., outer catheter 22, can be secured to a handle. The outer catheter 22 is retracted during placement of the sealant. radial movement within the handle to minimize the effect of twisting forces on the tube 62. This allows the outer sleeve 62 / catheter 22 to rotate freely within the handle. It becomes possible to do this.

[0055] With the closure system 120 connected to the procedure sheath 10, expansion of the inner catheter 24 The flexible structure 26 can be expanded using a syringe 50 (see FIG. 9B). The expandable structure 26 may have an inflation indicator to indicate that the expandable structure 26 has expanded to a predetermined pressure. For example, the inflation indicator 154 When the expandable structure 26 is fully expanded, it can move from the first position to the second position. As shown in FIG. 9B, the inflation indicator 154 is in the second position. The inflation indicator 154 may protrude from the proximal end of the portion 130. The expandable structure 26 may be positioned elsewhere in the expandable portion 130. The inflation line 56 can then be sealed by closing the valve 52. With the closure structure 26 expanded, the closure system 120 and the procedure sheath 10 are The proximal end of the ... vessel wall V can be retracted until the proximal end of the vessel wall V abuts the inner surface of the vessel wall V.

[0056] The inner catheter 24 is moved by actuating or depressing the first actuator 132. Thus, it can be released from the outer catheter 22. When the inner catheter 24 is released, When the procedural sheath 10 and outer catheter 22 are inserted, the handle and procedural sheath are also simultaneously 1. The seal 18 is then retracted back relative to the inner catheter 24 to expose the seal 18. In this configuration, the handle portion 130 can be retracted (see FIG. 9C). A first access is used to retract outer catheter 22 while catheter 24 remains in place. The first actuator 132 slides over the first actuator 132. When the first actuator 132 is depressed, When the handle body 130 is slid rearward, it is possible to determine whether the seal is properly positioned. To display the image shown, the handle 130 covering the first actuator 132 is Sliding proximally exposes a window 182 through which visual indication 180 is visible. .

[0057] With the sealant 18 exposed, the sealant 18 is brought into contact with the outer surface of the blood vessel wall V and tamped. The support member 28 can be advanced to move the second actuator 134 forward. The lowering advances the support member 28 relative to the inner catheter 24 and the outer catheter 22. Also, a visual indicator 180 visible through a window 182 indicates the sealant's Shows different images indicating successful completion of tamping and start of seal activation downtime. It can be shown.

[0058] After the second actuator 134 is depressed, the third actuator 136 is depressed. Before being lowered, the inflation indicator 154 indicates that the expandable structure 26 is in an expanded configuration. A lockout mechanism is provided to prevent the third actuator 136 from being depressed while the (See FIG. 9E.) The inflation indicator 154 is located near the handle 130. The distal portion of the inflation indicator 154 passes through the distal portion of the third actuator 136. When the inflation indicator 154 is in the second position, When the handle 130 is extended beyond its proximal end (e.g., extending beyond the proximal end of the handle 130), it is an expandable structure. In addition to indicating that the body 26 is inflated, the inflation indicator 154 is integral with the There is further provided a blocking portion 140 located inside the handle body.

[0059] After the sealant 18 is tamped, the expandable structure 26 may, for example, open the valve 52. and deflating the expandable structure 26 using a syringe 50. (See FIG. 9F.) When the expandable structure 26 is in a contracted state, the expandable structure 26 is retracted through the seal 18 by actuating the third actuator 136. The inner catheter 24 can be connected to the outer catheter 22 and / or the support member 2. 8 (see FIG. 9G). Expandable structure through sealant 18 After retraction of body 26, sealant 18 is left in place against vessel wall V, and closure system 20 is The entire treatment sheath 10 can be removed from the body. Since the closure system 20 is connected to the sheath 10, the closure system 20 and the procedural sheath 10 can be removed simultaneously. Alternatively, the closure system 20 can be detached from the procedural sheath 10 and removed separately. can.

[0060] 10A-13B, the handle portion 130 of the closure system 120 has been further The inside of the handle 130 is shown in detail in FIGS. 10A-10B. The proximal 142 and distal 144 springs slide or glide within the handle when actuated. The distal sled assembly 144 includes a first actuation sled assembly 144, as shown in FIG. 10B. When the actuator 132 is depressed and the handle is retracted, the distal sled assembly The first actuator 132 may be integral with the handle so that the first actuator 132 moves distally relative to the handle. The proximal 142 and distal 144 sled assemblies are connected to the first actuator 132. handle 130 until it is fully depressed and locked in the depressed second position. When the first actuator 132 is depressed, the remote Both the distal sled assembly 144 and the proximal sled assembly 142 are unlocked and the hand When the proximal stem is retracted, it can move distally relative to the handle body 130. The red assembly 142 can house the inner catheter 24 and an inflation indicator. Cut.

[0061] Referring to FIG. 10C, the device is attached and locked to the procedural sheath with catch 40. An enlarged view of the position 120 is shown. The sheath catch or adapter 40 can be placed in any position or The port or irrigation line of the procedural sheath can be oriented The handle 130 can be rotated to adjust the grip for easier capture. It can be provided so that this can be done.

[0062] In addition to actuating the distal sled assembly, the first actuator 132 also As shown in 1A-C, the outer sleeve is successfully retracted and the seal is removed through the window 182. Visual guidance that can provide a storyboard for users to understand the placement 11A shows the first actuator of the handle body 130. 1 shows a portion including a first actuator 130, which is optionally A visual indicator to identify the first actuator in a series of actuators. When the first actuator 132 is actuated or depressed, A first image or visual indication becomes visible, e.g., as shown in FIG. 11B, indicating that the sealant A symbol such as a check mark or other suitable symbol may be inserted through window 182 to indicate placement. When the second actuator 134 is also depressed, the The leeboard further confirms that the sealant has been successfully tamped, as shown in FIG. 11C. You can display different images to communicate this: a check mark and a circle with a symbol inside it Although steps are shown, any visual cues or images may be used as appropriate to indicate completed steps. It can be used.

[0063] The second actuator 134 is connected to the first actuator 132 as shown in FIGS. 12A and 12B. 132 and a distal sled assembly 144 coupled to the support member 28 in a distal direction. The second actuator may include a cam drive mechanism that can tap the seal. The actuator 134 is located at the proximal end of the distal sled assembly 144 / first actuator 132. The angled surface 146 can interface with any of the distal sled assemblies 144. Support member 28 is secured to the support shaft 21 so that any distal movement can move support member 28 distally. 8. The second actuator 134 is depressed. When engaged, the distal surface 148 of the second actuator 134 tilts the distal sled assembly 144. The distal thread assembly 144 is pushed distally against the beveled surface 146, and the distal thread assembly The solid body 144 and the support member 28 are advanced distally, and the advancement of the support member 28 causes the sealant is compressed and tamped.

[0064] The third actuator 136 is a deflated air pump, as seen in FIGS. 13A and 13B. The expandable structure 26 can be depressed to retract into the support member 28. In an embodiment, retraction of the expandable structure 26 is shown in further enlarged internal views of FIGS. 13C and 13D. As can be seen in the figure, the third actuator 136 is This can be achieved by an arm 150 extending below the outer surface. 36 is depressed to allow arm 150 to engage inner catheter 24, Upon engagement with the catheter, the arms handle the catheter 24, as seen in FIG. 13D. 130 and retract the inner catheter 24 proximally. thereby allowing the expandable structure 26 to be retracted into the support member 28. The inner catheter 24 can be kinked at the proximal end.

[0065] Also indicated by an inflation indicator 154 extending beyond the proximal end of the handle 130. As shown, when the expandable structure 26 is in an expanded state, the third actuator 136 The lockout function prevents the inflation indicator from being pressed down. The indicator 154 extends distally and into the handle 130 and further includes a plurality of protrusions 14 0, and a plurality of protrusions 140 are provided at a distance from the central axis of the handle 130. The third actuator 136 is connected to the locking mechanism 136 and extends axially outward, preventing the third actuator 136 from being pushed down. acts as a stop. When the expandable structure 26 is deflated, the inflation indicator 1 54 can be moved distally so that it is no longer visible proximal to the handle This movement of the inflation indicator 154 locks the third actuator 136 in place. The position of the plurality of protrusions 140 can also be moved. The actuator 136 is freely depressed. This lockout feature allows the expandable structure to be retracted before it is fully deflated. This is useful to prevent accidental depression of the third actuator 136 so that In this embodiment, the lockout element extends axially toward the center of the handle 130 and At the same time, the third actuator 136 is provided with a support member 136a on the upper surface thereof so that the third actuator 136 is not pushed down. The distal arm of the stud may be a protrusion.

[0066] Another embodiment of the closure system 220 is shown in Figures 14A-15D. In the present invention, the closure system 220 includes a sealant placement, tamping, and expandable structure. Two actuators can be provided to help retract the vehicle. Similar features of the configuration have similar reference numbers.

[0067] Similar in function to the closure system 20 of FIG. 1B, the closure system 220 is configured to include a hub portion 14 (FIG. A procedural sheath (not shown) is inserted by inserting an outer catheter 22 through the procedural sheath (not shown). The outer catheter 22 can be inserted through a standard treatment sheath of 5F or larger. It can be sized to fit.

[0068] As seen in FIG. 14A, the handle 230 includes at least one actuator, In particular, it may include two actuators. Although not shown, a closing system 220 also has a sheath adapter 40 attached to the hub portion of the treatment sheath, similar to the previous embodiment. The closure system 220 can be advanced through the procedural sheath until it engages. and advancing the implant through the implant sheath and inserting the implant into the treatment sheath through the sheath adapter 40. Locking the rule can be done in the same way as in the previous embodiment.

[0069] Referring to FIG. 14A, the first actuator 222 and the second actuator 224 The handle 230 is shown having a first actuator 222 that, when actuated, The combined function of retracting the catheter 22 and tamping the sealant 18 is The second actuator 224 can be the same as the third actuator in the previous embodiment. The second actuator 224 may have the same function as the first actuator 36 and the second actuator 136. When lowered, the second actuator 224 moves the expandable structure 26 toward the support member or It can be retracted into the tube 28. Figures 14A-15D show only the closure device. However, the device is not shown in FIGS. 1B-1I and 9A-9C to perform the closure process at the arteriotomy. It can be used in a similar manner to that shown in G.

[0070] Also, by including a tension indicator window 228, the tension indicator window 228 can be easily adjusted to show the tension, as shown in FIG. 14C. The indicator 206 can be incorporated into the design of the handle 230, and the tension indicator - Expandable when the expandable structure 26 is placed on the inner surface of the vessel wall V through the window 228 A diagram or image can be seen that indicates whether the structure 26 has been properly tensioned. The force indicator 206 allows the expandable structure 26 to be pressed to the appropriate amount prior to placing the sealant 18. A visual cue can be provided to the user when the required tension is applied. If excessive tension is applied to the arterial wall by the structure 26, the artery may lose its initial pressure during the closure process. widening (e.g., dilating) a blood vessel so that it is displaced from its original anatomical location, e.g., It is useful to know when the tension is appropriate, as this dilation of the artery With the sealant 18 in place, the expandable structure 26 is evacuated and The expanded blood vessels are then drawn into the artery as it returns to its normal position after the device 220 is removed from the patient. Tissue compression around the tube causes the hydrogel sealant 18 to separate slightly from the surface of the puncture site. There is a possibility.

[0071] Referring to Figure 14B, an internal view of the handle 230 is shown. The handle 230 As with the other embodiments, a proximal thread assembly capable of accommodating the inner catheter 24 The expandable structure 26 may be expanded within the patient's artery and may include a catheter 242. When pulled back into the opening, the expandable structure 26 provides resistance when it is pressed against the vessel wall. The force applied to the expandable structure 26 is transmitted to the proximal sled assembly 24. 2. The proximal thread assembly 242 is configured to allow the expandable structure 26 to It can move distally when under force, thereby acting as a tension indicator The tension indicator 206 compresses the tension spring 202 housed within the tension indicator 206. When the force on the flexible structure 26 exceeds the preload on the tension spring 202, it begins to move distally. The first actuator 222 can be connected to the protrusion or black The wire is within the appropriate tension zone 226 of the device handle 230 or is in the appropriate tension zone 22 6, and the tension indicator 206 is aligned with the tension indicator window 206 as shown in FIG. 14C. It can be pressed down when it indicates that it is in the proper position within 228.

[0072] If the tension indicator 206 is not aligned with the appropriate tension zone 226, the expandable The tension applied to the structure 26 is not in the proper tension zone (e.g., the black band). The actuator 222 cannot be actuated or depressed. The rotor zone 226 may be inflated when inadequate tension is applied by the expandable structure 26. A lockout function that can prevent the first actuator 222 from being depressed is provided. The tension zone 226 can be depicted in any manner, and may include a In this embodiment, the handle device 230 is shown with a black line. The position is located within the appropriate tension zone. The tension indicator 206 is an expandable structure. a handle assembly that can slide distally based on tension applied to the body 26; The inner sliding element of the body 230 can be used to apply the correct tension to the expandable structure. To ensure that tension is applied to the structure 26, the user may adjust the tension indicator 206 Extend the expandable structure 26 until the black line on the top coincides with the black line on the handle of the tension zone 226. The tension can be adjusted as needed, in one embodiment, by adjusting the handle of the closure device. Alternatively, the expandable structure can be adjusted by pulling back or loosening the Any other visual indicator system may be used as appropriate to indicate the appropriate tension being applied to the body 26. It is possible.

[0073] Referring to Figures 15A-D, an internal view of the handle housing is shown. Although the tension indicator 206 is not shown, it may be installed as needed as shown in FIGS. 14A-C. The first actuator 2 may include a tension indicator 206. FIG. 2 shows the handle 230 at rest, before the first actuator 22 is depressed. The inner rib 212 of the actuator 222 engages or abuts the inclined surface 214 of the pull rack 208. The pull rack 208 is connected to the outer sleeve assembly 62 (not shown). When the first actuator 222 is actuated or depressed, the pull The rack 208 may begin to move proximally, for example, away from the sheath adapter 40. The pull rack 208 is moved proximally by actuation of the first actuator 222. As a result, the outer sleeve 62 also begins to move proximally, causing the adjacent set of arteriotomy to The first actuator 222 is depressed first, exposing the sealant in the fabric path. When the sealant is removed, as shown in FIG. 15B, the sealant can begin to be exposed by retracting the sleeve. .

[0074] As shown in FIG. 15B, when the first actuator 222 is partially depressed, the first actuator The distal surface 218 of the actuator 222 is capable of engaging with the push rack 210; At the point where the sealant is at least partially exposed, in one embodiment about 50%, the push rack 210 The prongs can begin to move distally, for example, toward the sheath adapter 40. The push rack 210 is supported by a support member 214 when the push rack 210 is moved distally. 28 is also moved distally to bring the sealant closer to the vessel wall at the arteriotomy site, effectively tamping it down. The pull rack 208 can be connected to the support member 28 or the tamping tube. After approximately 50% of the seal is exposed by the movement (e.g., the first actuator is pressed When the push rack 210 and the pull rack 208 are in their respective The seals are moved in the directions simultaneously or relatively simultaneously to expose and tamp the seal. It is preferable to expose at least a portion of the sealant before tamping. This may help alleviate blockage of the pump and / or seal. Approximately 50% of the sealant is exposed before engaging the shell 210. and exposing any other suitable amount less than or greater than 50% of the sealant before engaging the sealant. It is possible.

[0075] In FIG. 15C, the pull rack 214 has been moved proximally relative to its starting position. is shown in its final position, while the push rack 216 is shown in its distal position relative to its starting position. FIG. 15D shows the fully depressed first position. The actuator 222 is connected to the tilting lever of the push rack 210 exposed inside the handle 230. Shown with ramp 216. First actuator 222, or combination actuator The pull rack 208 and the push rack 209 are driven by a cam drive mechanism similar to that of the previous embodiment. The first actuator 222 can drive the racks 210. The rack may include a mechanism for driving the rack in a desired direction.

[0076] Although not shown, by depressing the second actuator 224, the previous embodiment The third actuator functions in the same way as the third actuator in the and an expandable structure, as indicated by expansion indicator 254. 26 is still inflated, preventing the second actuator 224 from being depressed. The lockout mechanism can further include a lockout mechanism that can As shown in A, 10B, 13A and 13B, a blocking portion or is similar to that described above with respect to the second embodiment having multiple protrusions 140.

[0077] This embodiment illustrates a handle device 230 having two actuators. The handle may have more or fewer actuators than those described herein. For example, the handle may be a single object that performs all of the functions described herein. It may have only one actuator, or one that performs one or more functions. The actuator is provided with the remaining functions, and other methods are used for the closing device. The handle may have one or more actuators as required.

[0078] Figure 3 can be fitted to any sheath with a side port or irrigation line. The sheath adapter 40 can be directly or The handle portion 30 or the handle 32 is connected to the catheter shaft or other connecting structure via an intervening catheter shaft or other connecting structure. It may be integral with a separate component connected to portion 30 .

[0079] As shown in FIG. 3, the sheath adapter 40 can have any suitable shape. In particular, it may have a generally tubular, cylindrical, or generally frusto-conical shape. The adapter 40 may be made of polycarbonate, ABS, silicone, elastomer, or other suitable material. The elastomeric material may be used to allow the sheath adapter 40 to fit the sheath 10. It is useful for allowing gripping of the side port 16 or irrigation line 12. could be.

[0080] The sheath adapter 40 is adapted to connect to the side port 16 or irrigation line of the treatment sheath 10. bayonet connectors that can clip around lateral retention surfaces, such as the distally facing surfaces on the stent 12. a mounting portion, such as a connector or hook portion 42, that can be releasably attached to the procedural sheath; The hook portion 42 may include a hooking structure. The sheath adapter 40 may be configured to form a passageway 44 that can guide the sheath 12 into engagement with the sheath adapter 40. The hook portion 42 can be rotated axially and rotationally to disengage the hook portion 42 from the sheath 10. The shape can be such that both movements are required.

[0081] The passageway 44 has a distally facing edge 48a, an outer lateral edge 48b, a proximally facing edge 48c, and an inner lateral edge 48d. The edges defining the passageway 44 may be generally The distally facing edge 48a and the hook edge 48e may be straight or curved. The distance D1 between the side port 16 and the irrigation line 12 is set to 0.5 mm. For example, the distance D1 can be sized to allow for the side port 12 or the The diameter of the ligation line 12 may be within about 10% or about 20% of the diameter of the ligation line 12. is about 3F to about 3F, including about 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, or 11F. between about 3F and about 6F, between about 5F and about 8F, or between about 7F and about 11F, for example, between about 3F and about 6F, between about 5F and about 8F, or between about 7F and about 11F The temperature can be between 10°F and 10°C.

[0082] Distance D1 is less than distance D2 between distally facing edge 48a and proximally facing edge 48c (approximately 60% of D2). less than about 50 percent of D2, less than about 40 percent of D2, less than about 3 0 percent, less than about 20 percent of D2, etc.

[0083] The distance D3 between the outer lateral edge 48b and the inner lateral edge 48d is 16 or irrigation line 12. For example, The distance D3 should be within 10% of the diameter of the side port 16 or irrigation line 12. The diameter can be approximately 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F or 11F. Including, between about 3F and about 11F, for example, between about 3F and about 6F, between about 5F and about 8F , or between about 7 F and 10 F. Distance D3 is less than distance D1. can be done.

[0084] The inner lateral edge 48d is adapted to prevent the side port 16 or the irrigation port from being in contact with the closure system 20 when rotated. The length of the sheath adapter 40 is set to a length suitable for preventing the connection line 12 from coming off the sheath adapter 40. For example, the length of the inner lateral edge 48d can be at least as long as the side port 16 or The length of the inner lateral edge 48d can be the same as the diameter of the irrigation line 12. The length is at least about 20% of the length L of the sheath adapter 40, -About 30% of the length L of the sheath adapter 40, or at least about 40% of the length L of the sheath adapter 40 The length of the inner lateral edge 48d must be at least as long as the distance D3. can be done.

[0085] Although not shown, in some embodiments, the distance D3 is from the proximally facing edge 48c to the hook. The hook portion 46 may be spring-like. 16 or irrigation line 12 can be moved toward proximal edge 48c. to move away from outer lateral edge 48b to allow movement of outer lateral edge 48a. The distance D3 between the hook portion 46 and the inner lateral edge 48d can be increased. To hold the side port 16 or irrigation line 12, You can bounce back like this.

[0086] FIG. 4 is for engaging any sheath with a side port or irrigation line. 1 shows an enlarged view of another sheath adapter 70 that can be used with the closure system 20. The sheath adapter 70 may be attached to the handle portion 30 or a separate part connected to the handle portion 30. It can be integral with the components of.

[0087] As shown in FIG. 4, the sheath adapter 70 has a generally cylindrical or generally frustoconical shape. The sheath adapter 70 can be made of polycarbonate, ABS, silicone, The sheath may include an elastomer or other suitable material. The adapter 40 grips the side port 16 of the sheath 10 or the irrigation line 12. It may be useful to enable

[0088] The sheath adapter 70 is an attachment structure that can be releasably attached to a treatment sheath. For example, the mounting structure may include a first A first hook portion 72 having a hook end 72a and a second hook portion 74a. At least one of the first and second hook portions 72, 74 may be included. portion extends distally beyond the distally facing edge 76 of the remainder of the sheath adapter 70. can be done.

[0089] The first hook portion 72 and the second hook portion 74 have roughly the same shape and size, but the first The lower surfaces 72b, 74b of the second hook portions 72, 74 are tapering inward and toward each other to guide the connection lines 12 toward the passages 78. The sheath adapter 70 can be inverted relative to the first hook portion. 72 and the second hook portion 74 and through the longitudinal axis of the sheath adapter 70. It may be generally symmetrical across the plane of extension.

[0090] The distance B1 between the first hook end 72a and the second hook end 74a is Or to prevent the irrigation line 12 from accidentally coming off the sheath adapter 70 It can be smaller than the diameter of the side port 16 or the irrigation line 12. The lock ends 72a, 74a are positioned such that the side port 16 or irrigation line 12 passes through the passage 78. The deflection can be increased to increase the distance B1 to allow the vehicle to enter the side pocket. When the side port 16 or irrigation line 12 enters the passage 78, The connection line 12 is held between the hook ends 72a, 74a and the distally facing edge 78d. The spring-like hook ends 72a and 74a are positioned such that they are in contact with the side port 1 during normal use. 6 or irrigation line 12, but the sheath If the adapter 70 needs to be removed, the user may be overwhelmed.

[0091] Each hook portion 72, 74 may define a portion of a passageway 78. 2, 74 have an inner lateral edge 78a, a proximally facing edge 78b, an outer lateral edge 78c, and a distally facing edge 78 The edges defining the passageway 78 may be generally straight or curved. This can be done.

[0092] The distance B2 between the inner lateral edge 78a and the outer lateral edge 78c is of the hook portions 72, 74 to allow the connection line 12 to enter the passage 78. It can be sized to allow for the necessary bending to each outer lateral edge 78c.

[0093] FIG. 5 is for engaging any sheath with a side port or irrigation line. 1 shows an enlarged view of another sheath adapter 80 that can be used with the closure system 20. The sheath adapter 80 may be attached to the handle portion 30 or to a separate device connected to the handle portion 30. As shown in FIG. 5, the sheath adapter 80 can be integral with the It may include a proximal flange 82 that engages the handle portion 30 .

[0094] As shown in FIG. 5, the sheath adapter 80 has a generally cylindrical or generally frustoconical shape. The sheath adapter 80 can be made of polycarbonate, ABS, silicone, The sheath may include an elastomer or other suitable material. The adapter 40 grips the side port 16 of the sheath 10 or the irrigation line 12. It may be useful to enable

[0095] The sheath adapter 80 is configured to connect a procedural sheath, such as a bayonet connector or hook portion 84. The sheath adapter may include an attachment structure that can be releasably attached to the sheath adapter. A distally facing edge 88 of the hook 80 may extend distally beyond the hook portion 84 .

[0096] The hook portion 84 may define a passageway 86. The passageway 86 may include a hook edge 86a. , proximally facing edge 84b, first medial lateral edge 86c, first distally facing edge 86d, second medial lateral edge 86e , a second distally facing edge 86f, and an outer lateral edge 86g. The edges defining 6 can be generally straight or curved.

[0097] The hook edge 86a guides the side port 16 or irrigation line 12 toward the passage 86. For ease of guidance, the nozzle may taper inwardly toward the passageway 86. The distance C1 between the end edge 86a and the outer lateral edge 86g is The hook portion can be sized to prevent the line 12 from inadvertently exiting the passage 86. Portion 84 allows side port 16 or irrigation line 12 to enter passageway 106. In order to expand C1 to make it possible to The side port 16 or irrigation line may be a spring member. After the nozzle 12 is placed in the passage 86, the hook portion 84 is so that the connection line 12 is held between the proximally facing edge 86b and the second distally facing edge 86f. It can return to its original state.

[0098] The second distally facing edge 86e is adjacent to the first distally facing edge 86c and is bounded by a second inner lateral edge 86e. The second distal edge 86e is spaced from the first distal edge 86c by a 16 or irrigation line 12 toward the inner lateral surface 86c. The distance C2 between the second inner lateral edge 86e and the outer lateral edge 86g is The distance C1 is larger than the distance C1 and is large enough to accommodate the side port 16 or irrigation line 12. In one embodiment, C1 can be about 0.126 inches (3.20 mm). C2 can be approximately 0.210 inches (5.33 mm). However, other suitable dimensions are possible.

[0099] The length of the proximal facing edge 86b and / or the first distal facing edge 86d may be adjusted to fit the length of the side port 16 or the inlet port 16a. The hook portion 84 deflects outward a distance C to allow passage of the ligation line 12. For example, the proximal-facing edge 86b and / or the first distal edge 86c may be sufficient to enlarge the first distal edge 86d. The facing edge 86d is at least about 20% of the circumference of the sheath adapter 80, at least about 10% of the circumference of the sheath adapter 80. about 30% of the circumference of the sheath adapter, at least about 40% of the circumference of the sheath adapter 80, or The proximal-facing edge 8 can extend at least about 50% of the circumference of the sheath adapter 80. The length of 6b can be greater than the length of the first distally facing edge 86d.

[0100] Alternatively, the distance C3 between the proximally facing edge 86b and the first distally facing edge 86d is 16 or irrigation line 12 may be sized to allow passage 86 to cross. The distance C3 is 10 times the diameter of the side port 16 or irrigation line 12. % or about 20%. Distance C3 may be smaller than distance C1. Cut.

[0101] FIG. 6 is for engaging any sheath with a side port or irrigation line. 1 shows an enlarged view of another sheath adapter 90 that can be used with the closure system 20. The sheath adapter 90 is similar in many respects to the sheath adapter 80 described above. Therefore, the symbols used to identify features of the sheath adapter 80 are - Incremented by 10 to identify 90 similar features.

[0102] Unlike the sheath adapter 80, the hook edge 96a of the sheath adapter 90 is generally straight. The distal portion of the outer lateral edge 96h is connected to the side port 16 or the irrigation line 1 The outer lateral edge 96h may be tapered inward to guide the outer lateral edge 96h into the passage 96. The distal portion and the proximal portion of outer lateral edge 96g are separated by a proximally facing step 96i.

[0103] The sheath adapter 90 has a protrusion or projection extending radially outward from the sheath adapter 90. may include a thumb grip 91, and the protruding portion or thumb grip 91 may be configured to allow the user to 1 to allow removal of the sheath 10 from the sheath adapter 90. The lock end 96a is bent outward away from the central axis of the sheath adapter 90. Make it possible.

[0104] FIG. 7 is for engaging any sheath with a side port or irrigation line. 1 shows an enlarged view of another sheath adapter 100 that can be used with the closure system 20. The sheath adapter 100 is attached to the handle portion 30 or to a portion connected to the handle portion 30. As shown in FIG. 7, the sheath adapter 100 The proximal flange 102 may include a proximal flange 102 that engages the handle portion 30. 102 allows users to choose the optimal position to accommodate side ports positioned at various angles. The sheath adapter 100 is rotated for setting, but the sheath adapter 100 during treatment The locking mechanism may have a detent mechanism that allows the locking mechanism to prevent rotation.

[0105] As shown in FIG. 7, the sheath adapter 100 includes a bayonet connector or hook portion. 104. The procedural sheath may include an attachment structure that can be releasably attached to a procedural sheath such as 104. The hook portion 104 can protrude radially outward from the sheath adapter 100. The hook portion 104 can be axially rotated to remove the sheath adapter 100 from the sheath 10. Alternatively, the hook portion 1 may be shaped such that rotational movement is required. 04 must be pushed down to remove the sheath adapter 100 from the sheath 10. It can be configured as follows.

[0106] The hook portion 104 may define a passageway 106. The passageway 106 may extend from the lower hook Edge 106a, hook edge 106b, upper hook edge 106c, inner lateral edge 106d, distally facing The passageway 106 may be defined by an edge 106e, an outer lateral edge 106f, and an outer lateral edge 106f. The hooking edge can be generally straight or curved. To guide the outlet port 16 or the irrigation line 12 toward the passage 106, Generally, it can be tapered gradually inward.

[0107] The distance E1 between the hook end edge 106b and the outer lateral edge 106f is The ligation line 12 may be sized to prevent it from inadvertently slipping out of the passageway 106. The hook portion 104 is configured to allow the side port 16 or irrigation line 12 to pass through the passage 1. In order to allow the vehicle to enter the 06 position, the distance E3 is decreased and the distance E1 is increased. The side poles 106a and 106b may be spring members that can be deflected toward the side lateral edges 106d. After the outlet 16 or irrigation line 12 is placed in the passageway 106, the hook portion 104 The side port 16 or irrigation line 12 is connected to the distal edge 106e and the hook edge 106f. 106b.

[0108] The length of the upper hook edge 106c is such that the hook portion 84 diverges toward the inner lateral edge 106d. and allows passage of the side port 16 or irrigation line 12 into the passage 106. The length of the upper hook edge 106c can be sufficient to allow the hook edge 1 06 to facilitate retention of side port 16 or irrigation line 12 When the closure system is rotated or pulled, the sheath 10 is pulled into the sheath adapter 10. 0. For example, the upper hook edge 1 The length of 06c should be at least about 20% of the length L of the sheath adapter 100, Approximately 30% of the length L of the sheath adapter 100, or at least The length can be about 40% of L.

[0109] The distally facing edge 106e allows the side port 16 or irrigation line 12 to pass through the passage 106. generally so as to guide the hook toward the portion between the upper hook edge 106c and the inner lateral edge 106d. The distance E2 between the inner lateral edge 106d and the outer lateral edge 106f is The distance E1 can be greater than the distance E1. In one embodiment, E1 is about 0.115 inches (2.9 2 mm) and E2 is approximately 0.210 inches (5.334 mm) However, other suitable dimensions may be possible.

[0110] FIG. 8 is a side port 16 or irrigation line 12 engaging any sheath. 1 shows another sheath adapter 110 that can be used to a proximal flange 112 that is integral with or engages the handle portion 30; It is possible.

[0111] As shown in FIG. 8, the sheath adapter 110 has a generally cylindrical or generally truncated cone shape. The sheath adapter 110 may be made of polycarbonate, ABS, silicone, or the like. The material may include a silicone, an elastomer, or other suitable material. The side adapter 110 connects the side port 16 of the sheath 10 or the irrigation line 12 This can be useful to allow for grasping.

[0112] The sheath adapter 110 is adapted to connect to the side port 16 or irrigation lab of the treatment sheath 10. 12. A bayonet connector or hook portion 114 that can fasten around the connector 12. The hook may include an attachment structure that can be releasably attached to a suitable treatment sheath. The sheath portion 116 extends distally beyond the distal end 118 of the remainder of the sheath adapter 110. The hook portion 114 can be attached to the side port 16 or the irrigation line 1 2. The hook portion 42 may be formed with a passage 116 for retaining the hook portion 42. 42 from the sheath 10 requires both axial and rotational movement. It can be made into a shape.

[0113] The passageway 116 is bounded by an outer lateral edge 116a, a proximally facing edge 116b, and an inner lateral edge 116c. The edges defining the passageway 116 may be generally straight or curved. The distance F1 between the outer lateral edge 116a and the inner lateral edge 116c is 6 or irrigation line 12 into the passageway 116. For example, the distance F1 can be determined by the diameter of the side port 12 or the irrigation line 12. In one embodiment, F1 is about 0.2 00 inches (5.08 mm), but other suitable dimensions are possible. do.

[0114] In some embodiments, the distance F1 is from the proximally facing edge 116b to the hook edge 116d. The hook portion 114 is spring-like and can be attached to the side port 16 or allows the irrigation line 12 to move toward the proximal-facing edge 116b. In order to increase the distance D1 between the outer lateral edge 116a and the inner lateral edge 116c, The hook portion 114 can be moved away from the side port 116c. 6 or springs back toward the inner lateral edge 116c to retain the irrigation line 12. It is possible.

[0115] Although not shown, an embodiment of the sheath adapter may be adapted for engagement with the sheath 10, e.g., Including barbs, threads, flanges, or other features to facilitate a snap or friction fit These features may include side ports, irrigation lines, or procedural sheaths. It can be used to engage the exterior or interior surface of the hub. It may also be used to permanently connect the sheath 10 to the sheath adapter described above.

[0116] term As used herein, the relative terms "proximal" and "distal" refer to the location of the closure system. Thus, proximal refers to the direction of the handle of the closure system and distal refers to the direction of the closure. It points towards the distal tip of the chain system.

[0117] Conditional language used herein, such as, among other things, "can," "might," "could," "could" "may," "may," "for example," etc., unless otherwise noted or used. Generally, some embodiments may refer to some features, elements, and and / or steps, but other embodiments are not. Therefore, such conditional language may be used to clarify whether the features, elements, and / or steps are of any particular interest. Generally, these features, elements, and methods are used in conjunction with the present invention, regardless of whether they are included or implemented in a particular embodiment. It is not intended to imply that elements and / or steps are in any way required by one or more embodiments. It is not intended to be.

[0118] Terms such as "comprise," "include," and "have" are synonymous and are used to refer to an inclusive, open and does not exclude additional elements, features, acts, operations, etc. " is used in an inclusive (and not exclusive) sense, e.g., to describe a list of elements. When used in conjunction, the term "or" refers to one, some, or all of the elements in a list. means everything.

[0119] As used herein, the terms "generally," "about," and "substantially" remain the same. It represents an amount close to the stated amount that performs the desired function or achieves the desired result. For example, The terms "approximately," "about," and "substantially" mean, as the context indicates, within 10% of the stated amount. It can refer to an amount less than %.

[0120] The ranges disclosed herein also include any and all overlaps, subranges, and combinations thereof. "up to," "at least," "greater than," "less than," " Words such as "between" and "and the like include the recited numbers. For example, "approximately 10%" should be replaced with "10%." Includes:

[0121] The methods disclosed herein do not have to be performed in the order presented. The method includes actions taken by the actor, but does not explicitly or implicitly include those actions by third parties. For example, an action such as "tamp the seal" can be "Instructing the tamping of the seal."

[0122] While certain embodiments and examples are described herein, those skilled in the art will appreciate that the present disclosure provides Many aspects of the closure system shown and described may be used in further alternative or acceptable implementations. It is understood that the various aspects of the present invention may be combined and / or modified differently to form various embodiments. All such modifications and variations are included herein within the scope of this disclosure. It is intended that various designs and approaches be included. No feature, structure, or step is essential or required.

[0123] Some embodiments are described with reference to the accompanying drawings, which, however, are not to scale. Please understand that the distances, angles, etc. are merely illustrative and are not necessarily The components shown do not bear precise relation to the actual dimensions and layout of the apparatus. Any changes or modifications relating to the various embodiments may be made without departing from the spirit or scope of the present invention. The disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. It can be used in all other embodiments described herein. Any of the methods described can be performed using any apparatus suitable for carrying out the steps described. It will be appreciated that this can be implemented.

[0124] For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, it will be apparent to those skilled in the art that the present disclosure will be readily apparent to those skilled in the art from the following detailed description of the present invention, as well as from other aspects of the present invention that may be taught or suggested herein. Achieving one advantage or group of advantages taught herein without necessarily achieving all advantages is not It will be appreciated that the present invention may be embodied or carried out in any manner.

[0125] Additionally, while exemplary embodiments are described herein, the scope of any and all embodiments is , equivalent elements, modifications, omissions, etc. (e.g., various The present invention includes any combination, adaptation and / or modification of aspects across various embodiments. Any limitations in scope should be interpreted broadly based on the language used in the claims. The present invention is not limited to the examples described herein, and these The examples should not be construed as being exclusive. The operation may involve rearranging actions and / or inserting additional actions and / or removing actions. Therefore, the present specification and examples may be modified in any way, including by deleting the content. The following claims and their equivalents should be construed as illustrative only and the true scope and spirit of the invention will be determined by the appended claims. It is intended that the full range of

Claims

1. 1. A method of sealing an arteriotomy, comprising: The handle and a sheath adapter extending from the handle portion and including an attachment structure; an outer catheter extending from the handle portion; a catheter extending through the outer catheter and removably secured to the outer catheter; An inner catheter; A support tube located radially between the outer catheter and the inner catheter. Bu and, a sealant disposed in a distal portion of the outer catheter; a closure system comprising: a procedural sheath extending through the arteriotomy; And, The attachment structure of the sheath adapter is attached to a side port or an irrigation port of the treatment sheath. The sheath attachment of the closure system is releasably attached to a connection line. fixing an adapter to the treatment sheath; The procedure sheath and the outer catheter are then moved toward the inner catheter to expose the sealant. retracting said handle portion to retract relative to the tail; A method comprising:

2. The sheath adapter is fixed to the treatment sheath. the sheath adapter for attachment to the side port or the irrigation line.

10. The method of claim 1, further comprising rotating and axially moving the

3. and expanding the distal portion of the outer catheter by expanding the sealant. The method of claim 1 .

4. During advancement of the closure system through the procedural sheath, the inner catheter The method of claim 1, wherein the hydroxyl group is immobilized on a hydroxyl group.

5. The method of claim 4 further comprising releasing the inner catheter from the outer catheter. How to post.

6. The method of claim 1 further comprising tamping the seal with the support tube. Law.

7. The method of claim 1 further comprising releasing the closure system from the procedure sheath. Law.

8. 1. A closure system for closing an arteriotomy, comprising: The handle and Sheath adapter including attachment structure for removable attachment to a procedural sheath and, an outer catheter extending distally from the handle portion, the outer catheter having a proximal portion and a distal portion; an outer catheter including: an inner catheter extending through the outer catheter, an inner catheter axially movable relative to the side catheter; a sealant disposed in a distal portion of the outer catheter; The outer catheter and the inner catheter are adjacent to and radially adjacent to the sealant. and the support tube between A closure system comprising:

9. The sheath adapter has a proximal flange configured to engage the handle portion. The closure system of claim 8 , comprising:

10. 9. The closure system of claim 8, wherein the sheath adapter and the handle portion are integral. Tem.

11. The distal portion of the outer catheter comprises an inner sleeve and an outer catheter surrounding the inner sleeve.

9. The closure system of claim 8, comprising a sleeve.

12. The closure system of claim 11 , wherein the proximal portion of the outer catheter comprises a single layer.

13. the inner sleeve having a first slit and the outer sleeve having a second slit; The closure system of claim 11.

14. 14. The method of claim 13, wherein the first slit is circumferentially offset from the second slit. The closure system described.

15. the first slit is circumferentially offset from the second slit by approximately 180 degrees.

14. The closure system of claim 13.

16. The inner catheter includes an expandable structure disposed in a distal portion of the inner catheter. The closure system of claim 8 , comprising:

17. 1. A closure system for closing an arteriotomy, comprising: The handle and an outer catheter extending from the handle portion, the outer catheter including a proximal portion and a distal portion; the distal portion includes an inner sleeve and an outer sleeve surrounding the inner sleeve; The inner sleeve has a first slit, and the outer sleeve extends from the first slit to a circumferential an outer catheter including a second slit offset in the direction of the catheter; an inner catheter extending through the outer catheter, a releasably secured inner catheter; a sealant disposed in a distal portion of the outer catheter; The outer catheter and the inner catheter are adjacent to and radially adjacent to the sealant. and the support tube between A closure system comprising:

18. The closure system of claim 17 , wherein the proximal portion of the outer catheter comprises a single layer.

19. the first slit is circumferentially offset from the second slit by approximately 180 degrees.

18. The closure system of claim 17.

20. The first slit and the second slit are positioned distally relative to the support tube prior to deployment.

18. The closure system of claim 17.

21. 1. A method of sealing an arteriotomy, comprising: The handle and a sheath adapter extending from the handle portion and including an attachment structure; an outer catheter extending from the handle portion; a catheter extending through the outer catheter and removably secured to the outer catheter; An inner catheter; an expandable member disposed in a distal portion of the inner catheter; a first actuator mechanism attached to the handle portion; a sealant disposed in a distal portion of the outer catheter; a closure system comprising: a procedural sheath extending through the arteriotomy; And, The sealant is placed in the arteriotomy and the sealant is applied to the blood vessel of the arteriotomy. depressing the first actuator mechanism to tamping against a wall; A method comprising:

22. The attachment structure of the sheath adapter is attached to a side port or an irrigation port of the treatment sheath. The sheath attachment of the closure system is releasably attached to a connection line.

22. The method of claim 21, further comprising securing an adapter to the procedure sheath.

23. Depressing the first actuator causes the outer seal to be exposed.

22. The method of claim 21, comprising moving the side catheter proximally.

24. 22. The method of claim 21, wherein the handle portion further comprises a second actuator mechanism.

25. the second actuator for retracting the expandable member into the handle portion; 25. The method of claim 24, further comprising depressing the mechanism.

26. The closure system is configured to radially separate the outer catheter from the inner catheter. The method of claim 21 further comprising a support tube disposed therebetween.

27. 27. The method of claim 26, wherein the seal is tamped by actuation of the support tube. How to do it.

28. The support tube is actuated by depressing the first actuator mechanism.

28. The method of claim 27,

29. The handle portion is adapted to engage the second actuator when the expandable structure is in an expanded state.

26. The device of claim 25, further comprising a lockout mechanism to prevent depression of the actuator mechanism. How to post.

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