Device and method for sealing a vascular puncture

Abstract

The present invention relates to an apparatus and method for sealing a vascular perforation, and discloses a closure system for delivering a sealant to an arteriotomy. The distal section of the closure system may include overlapping inner and outer sleeves that can expand when the sealant expands. The proximal section of the closure system may include a handle portion and a sheath adapter extending from the handle portion. The handle portion may include one or more actuators that, when depressed or engaged, may assist in the deployment of the sealant in the arteriotomy, and may also include tamping of the sealant and / or retraction of the expandable component. The sheath adapter may removably engage a side port or flush line of a standard procedure sheath. When the sheath adapter is secured to the procedure sheath, movement of the closure system may also move the procedure sheath.

Description

[0001] This application is a divisional application of the Chinese patent application entitled “Device and method for sealing blood vessel perforation” and application number 201580061128.1 filed on May 10, 2017. Technical Field

[0002] Percutaneous devices and methods for sealing a vascular perforation using a plug or sealant. Background Art

[0003] In order to obtain percutaneous access to the patient's vascular system, a hollow needle can be inserted through the patient's skin and into the blood vessel. A guide wire can be passed through the needle lumen into the blood vessel, so the needle can be removed. The introducer sheath can then be advanced into the blood vessel over the guide wire together with one or more dilators or thereafter. A catheter or other device can be advanced through the introducer sheath and over the guide wire to a position for performing the medical procedure. After completing the procedure, the (multiple) devices and the introducer sheath can be removed, leaving a perforation extending between the skin and the blood vessel wall. In order to seal the perforation, external pressure can be applied to the overlying tissue, for example manually and / or using a sandbag, until hemostasis occurs.

[0004] After completion of a diagnostic or therapeutic procedure (e.g., imaging procedure, angioplasty, stent delivery, or other) requiring access to the vascular system, the arteriotomy may be closed by various mechanical or biological solutions, such as by applying external pressure, tightening, suturing, and / or delivering a metal implant, plug, or sealant. However, many of these closure procedures may be time consuming, expensive, and uncomfortable for the patient, requiring the patient to remain immobilized in an operating room, catheterization laboratory, or holding area for a long period of time. In addition, some of these extended closure procedures may increase the risk of hematoma bleeding before hemostasis.

[0005] Some closure procedures may require a sheath exchange between an introducer sheath used during a diagnostic or therapeutic procedure and a sheath compatible with the closure system. This additional step can be time consuming and increase the risk of vascular injury and infection. Therefore, there remains a need for a closure method that eliminates the sheath exchange step. The present disclosure relates to a closure system that is compatible with a standard procedure sheath and integrates the standard procedure sheath into a sealant delivery method. Summary of the invention

[0006] Certain aspects of the present disclosure relate to methods and closure systems for sealing an arteriotomy. The closure system can be introduced through a standard procedure sheath and can include a sheath adapter configured to engage a procedure sheath, particularly a side port or flush line of the procedure sheath.

[0007] The introduction of the closure system through an existing procedural sheath eliminates the need for a custom sheath and eliminates the steps associated with sheath exchanges, including insertion of a guidewire, removal of the existing sheath, and insertion of a custom sheath. The elimination of sheath exchanges reduces the risk of arterial trauma and vascular injury, maintains arterial access, saves time, limits leaks and bleeding, and minimizes the potential for hematoma or infection. To eliminate the need for a custom sheath, an integrated sheath may be provided within the closure system and may include two sleeves, an inner sleeve and an outer sleeve.

[0008] In certain aspects, the method can include advancing a closure system through a procedure sheath extending through the arteriotomy. The method can also include securing a sheath adapter of the closure system to the procedure sheath by releasably attaching an attachment structure of the sheath adapter to a side port or flush line of the procedure sheath, and retracting a handle portion to retract the procedure sheath and the outer catheter relative to the inner catheter to expose the sealant. The method can further include tamping the sealant with a support tube member.

[0009] In certain aspects, the closure system can include a handle portion and a sheath adapter extending from the handle portion. The sheath adapter can include attachment structure for releasably attaching to a procedure sheath.

[0010] In certain aspects, the closure system may include an outer catheter extending from the handle portion. The outer catheter may include a proximal section and a distal section. The distal section may include an inner sleeve and an outer sleeve surrounding the inner sleeve. The inner sleeve may include a first slit, and the outer sleeve may include a second slit circumferentially displaced from the first slit. The slit in the outer sleeve or the primary sleeve may be provided to alleviate clogging of the sleeve / sealant and to facilitate friction when the sleeve is retracted during sealant delivery. The inner sleeve or the secondary sleeve may be provided to help accommodate the sealant when the end of the catheter is introduced into a blood vessel.

[0011] Optionally, any of the closure systems described above may include an inner catheter extending through the outer catheter, a support tube radially between the outer catheter and the inner catheter, and / or a sealant positioned in a distal section of the outer catheter.

[0012] In some embodiments, the closure system may include a first actuator configured to unlock the inner catheter relative to the handle. The handle may include a second actuator configured to advance the support tube or component through the procedure sheath to help compact the deployed sealant. For example, the handle may include a cam drive mechanism, which may be connected to the second actuator and configured to move the support component. In some aspects, the handle may also include a third actuator configured to retract the expandable structure through the sealant. The third actuator may be a retraction slider that moves relative to the inner shell portion.

[0013] In an alternative embodiment, the closure system may include a first actuator configured to retract the outer sleeve, thereby at least partially exposing the sealant, and tamping the sealant against the arteriotomy. A second actuator may be provided to retract the expandable structure.

[0014] Provided herein is a closure system comprising a handle having at least one actuator or other type of controller mechanism that can expose sealant, tamp sealant and / or retract an inflatable structure. In another embodiment, a closure system comprising a handle having at least two actuators or any other type of controller mechanism that can expose sealant, tamp sealant and retract an inflatable structure, either individually or in any combination thereof. In yet another embodiment, provided is a closure system comprising a handle having at least three actuators or any other type of controller mechanism that can expose sealant, then tamp sealant and finally retract an inflatable structure.

[0015] Any feature, structure or step disclosed herein may be replaced or combined with any other feature, structure or step disclosed or omitted herein. In addition, for the purpose of summarizing the present disclosure, certain aspects, advantages and features of the device are described herein. It will be understood that any or all such advantages may not be achieved according to any specific embodiment disclosed herein. Individual aspects of the present disclosure are not necessary or indispensable. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figures 1A-1I A method for delivering a sealant to an arteriotomy site using an embodiment of a closure system is shown.

[0017] Figure 2 Shown is a diagram taken through line 2-2. Figure 1B An enlarged view of the distal portion of the closure system is shown in FIG.

[0018] Figure 3 Shown is a diagram taken through line 3-3. Figure 1C An enlarged view of the sheath adapter of the closure system is shown in FIG.

[0019] Figure 4 Shows that Figures 1A-1I Another embodiment of a sheath adapter for use with a closure system is shown in FIG.

[0020] Figure 5 Shows that Figures 1A-1I Another embodiment of a sheath adapter for use with a closure system is shown in FIG.

[0021] Figure 6 Shows that Figures 1A-1I Another embodiment of a sheath adapter for use with a closure system is shown in FIG.

[0022] Figure 7 Shows that Figures 1A-1I Another embodiment of a sheath adapter for use with a closure system is shown in FIG.

[0023] Figure 8 Shows that Figures 1A-1I Another embodiment of a sheath adapter for use with a closure system is shown in FIG.

[0024] Figures 9A-9G A method for delivering a sealant to an arteriotomy site using a second embodiment of a closure system is shown.

[0025] Figures 10A-10B Show Figures 9A-9G A close-up of an interior cross section of a first actuator of the handle arrangement is shown in FIG.

[0026] Fig. 10C Show Figures 9A-9G A close up view of the distal end of the handle device shown in FIG.

[0027] Fig.11A -C shows Figures 9A-9G One aspect of the visual indication system on the handle is shown.

[0028] Figures 12A-12B Show Figures 9A-9G A close-up of the interior cross section of the second actuator of the handle device is shown in FIG.

[0029] Figures 13A-13D Show Figures 9A-9G A close-up of the interior cross section of the third actuator of the handle arrangement shown in FIG.

[0030] Fig.14A A third embodiment of a closure system for delivering a sealant to an arteriotomy site is shown.

[0031] Fig. 14B Show Fig.14A Internal cross-sectional view of the closure system.

[0032] Fig. 14C Show Fig.14A A close up view of the distal end of the handle device, further depicting the tension indicator.

[0033] Figures 15A-15D Show Fig.14A Internal cross-sectional view of the first actuator of the closing system in.

[0034] Various embodiments are depicted in the drawings for illustrative purposes and should in no way be construed as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments may be combined to form additional embodiments, which are part of the present disclosure. DETAILED DESCRIPTION

[0035] Provided herein are closure systems for delivering sealants to an arteriotomy and methods for sealing the arteriotomy. The closure systems also include a sheath adapter for attaching to an existing procedure sheath and, thus, avoiding the need for sheath exchange by removing the procedure sheath and inserting another sheath. Figures 1A-1I A method of delivering sealant 18 to an arteriotomy site 2 using closure system 20 is shown. Generally, closure system 20 can include a handle portion 30 having a first actuator 32, a second actuator 34, and a third actuator 36 that can be used to control features of closure system 20. Outer catheter 22 can extend from handle portion 30 and can move axially with handle portion 30. Handle portion 30 can include a sheath capture 40 or sheath adapter at a distal section of handle portion 30.

[0036] The inner catheter 24 may extend through the outer catheter 22. The inner catheter 24 may include an expandable structure 26 positioned at a distal section of the inner catheter 24. The inner catheter 24 may be moved axially relative to the outer catheter 22, for example, by actuating a first actuator 32 to release the inner catheter 24 from the outer catheter 22 and by retracting or advancing a third actuator 36 to move the inner catheter 24. Although the examples provided herein will describe the expandable structure 26 as a balloon, the expandable structure may alternatively be a basket, an expandable wire braid, an expandable mesh, an expandable frame, a rotatable structure, etc. In an alternative embodiment, the expandable structure may include a bioabsorbable pedal or other element on one end, for example, to provide tactile feedback to the user during a sealing procedure and / or sealing a puncture.

[0037] The sealant 18 may be positioned radially between the inner catheter 24 and the outer catheter 22 in the distal section 60 of the outer catheter 22. For example, the inner catheter 24 may extend through the sealant 18, while the outer catheter 22 surrounds the sealant 18. The sealant 18 may include a first proximal or main section formed of a freeze-dried hydrogel, and a second distal or terminal section (not shown) formed of a plurality of non-freeze-dried and / or non-cross-linked precursors, for example formed as a solid block or solid plug, fused or otherwise attached to and extending distally from the first section, as disclosed in U.S. Application No. 13 / 354,278, entitled “Apparatus and Methods for Sealing a Vascular Puncture,” filed on January 19, 2012, and incorporated herein by reference in its entirety. Additional details regarding sealant compositions may be found in U.S. Patent No. 7,335,330, entitled "Apparatus and methods for sealing a vascular puncture," filed November 5, 2004, and incorporated herein by reference in its entirety.

[0038] The support tube 28 or support member can be positioned radially proximal to the sealant 18 between the inner catheter 24 and the outer catheter 22. For example, the support member 28 can be tubular so that the inner catheter 24 can extend through the support member 28, and the outer catheter 22 surrounds the support member 28. Thus, the support member 28 can include an inner cavity extending between a proximal end and a distal end to accommodate the inner catheter 24 being slidably received therethrough. The support member 28 can support the sealant 18 during positioning of the sealant 18 and tamp the sealant 18 against the vessel wall V to close the arteriotomy 2. The support member 28 can be substantially rigid, semi-rigid and / or substantially flexible, for example, with sufficient column strength to allow the closure system to move proximally relative to the sealant 18 without bending the support member 28, and / or to allow the distal end of the support member 28 to be advanced to compress the sealant 18 within the perforation. The support member 28 can be moved axially relative to the expandable structures on the outer catheter 22 and the inner catheter 24, for example, by actuating the second actuator 34. In some configurations, actuating the second actuator 34 can release the inner catheter 24 from the support member 28.

[0039] In combination with or in lieu of any of the features described herein, the closure system 20 may include any of the features of the sealant delivery apparatus described in US Publication No. 2014 / 0025103, filed September 25, 2013, which is hereby incorporated by reference in its entirety.

[0040] Figure 1AA procedure sheath 10 is shown extending through the arteriotomy 2. The procedure sheath 10 may be the same sheath used during a diagnostic and / or therapeutic procedure. Figure 1A As shown in FIG. 1 , the procedure sheath 10 may include a hub portion 14 having a side port 16. The side port 16 may be secured to an irrigation and / or aspiration line 12.

[0041] Following a diagnostic and / or therapeutic procedure, the closure system 20 may be introduced through the procedure sheath 10 by introducing the outer catheter 22 through the hub portion 14 (see FIG. Figure 1B ). The outer catheter 22 may be sized to be compatible with a standard procedure sheath of 5F or larger.

[0042] Closure system 20 may be advanced through procedure sheath 10 until sheath adapter 40 engages hub portion 14 of procedure sheath 10 (see FIG. Figure 1C As described in further detail below, the sheath adapter 40 may be designed to removably engage the side port 16 of the hub portion 14 or the irrigation line 12.

[0043] With the closure system 20 coupled to the procedure sheath 10, the expandable structure 26 of the inner catheter 24 can be expanded using a syringe 50 (see Figure 1D ). The inflatable structure 26 may be inflated until the inflation indicator 54 indicates that the inflatable structure 26 is inflated to a predetermined pressure. For example, the inflation indicator 54 may move from the first position to the second position when the inflatable structure 26 is fully inflated. Figure 1D , the inflation indicator 54 in the second position may protrude from the proximal end of the handle portion 30; however, the inflation indicator 54 may be positioned elsewhere on the handle portion 30. Alternatively, any other suitable inflation indicator may be used. An alternative may include a pressure gauge with a dial having a needle indicator that displays the pressure reading and may show the full inflation of the balloon. After the inflatable structure 26 is inflated, the inflation line 56 may be sealed by closing the valve 52.

[0044] With the expandable structure 26 expanded, the closure system 20 and the procedure sheath 10 may be retracted until the expandable structure 26 abuts the inner surface of the vessel wall V (see FIG. Figure 1E ).

[0045] The inner catheter 24 can be released from the outer catheter 22 by actuating or depressing the first actuator 32. After the inner catheter 24 is released, the procedure sheath 10 and the outer catheter 22 can be retracted relative to the inner catheter 24 to expose the sealant 18 (see Figure 1F ). In this configuration, the handle portion 30 can be slid over the first actuator 32 to retract the outer catheter 22 while the inner catheter 24 remains in place.

[0046] With sealant 18 exposed, support member 28 may be advanced to compact sealant 18 against the outer surface of vessel wall V. As described above, actuation or depression of second actuator 34 may advance support member 28 relative to inner catheter 24 and outer catheter 22 .

[0047] After the sealant 18 has been tamped, the inflatable structure 26 may be deflated, for example, by opening the valve 52 and deflating the inflatable structure 26 using the syringe 50 (see FIG. Figure 1H ). In the event that the inflatable structure 26 is deflated, the inflatable structure 26 may be retracted through the sealant 18 by actuating or depressing the third actuator 36. The inner catheter 24 may be retracted relative to the outer catheter 22 and / or the support member 28 (see Fig. 1I ). After the expandable structure 26 is retracted through the sealant 18, the entire closure system 20 and procedure sheath 10 can be removed from the body, leaving the sealant 18 in place against the vessel wall V. Since the sheath adapter 40 is coupled to the procedure sheath 10, the closure system 20 and procedure sheath 10 can be removed together, but the closure system 20 can be detached from the procedure sheath 10 and removed separately.

[0048] Figure 2 An enlarged view of the closure system 20 before sealant delivery is shown. As described above, the sealant 18 may be positioned radially between the inner catheter 24 and the outer catheter 22 in the distal section 60 of the outer catheter 22. The support member 28 may be positioned proximal to the sealant 18. At least the distal section 60 of the outer catheter 22 may include an outer sleeve 62 and an inner sleeve 64. Each of the outer sleeve 62 and the inner sleeve 64 may include at least one slit 62a, 64a (e.g., one slit, two slits, three slits, or more) respectively. The outer sleeve 62 and the inner sleeve 64 may include the same number of slits or different numbers of slits. The slits 62a, 64a may be positioned so that the slits are not aligned with each other. In one aspect, the outer slit 62a may be positioned relative to the inner slit 64a (e.g., about 180 degrees apart). The inner sleeve 64 and the outer sleeve 62 may overlap such that the sealant 18 is circumferentially surrounded by the combination of the inner sleeve 64 and the outer sleeve 62 to minimize exposure to body fluids that enter the outer catheter 22 through the slits 62a, 64a.

[0049] In one aspect, the outer sleeve 62 can be longer than the inner sleeve 64. The outer sleeve 62 can extend back to the handle portion 30, for example so that it is integrated with the outer catheter, and the inner sleeve 64 can be secured to the outer sleeve 62 proximally of the slits 62a, 64a. The inner sleeve 64 and the outer sleeve 62 can be attached using heat attachment, adhesive attachment, mechanical attachment or other suitable attachment methods. In the case where the inner sleeve 64 is disposed within the outer sleeve 62, the inner diameter of the distal section 60 can be smaller than the inner diameter of the proximal section of the outer catheter 22.

[0050] In one case, the inner sleeve 64 can be harder than the outer sleeve 62, to provide support to the outer sleeve 62. For example, the inner sleeve 64 and the outer sleeve 62 can have the thickness of variation and / or be made of different materials. In one embodiment, the inner sleeve 64 can be made of polyimide or similar rigid polymer, and the outer sleeve 62 can be made of softer material (such as polyamide). In another embodiment, the outer sleeve 62 can be made of polyether block amide (such as Pebax®) or made of nylon material. However, any other suitable material can be used for the inner sleeve and the outer sleeve. Although not shown, in another aspect, the outer sleeve 62 can be thermoformed with less radius at the distal end, to provide atraumatic end during transmission.

[0051] The double-layer sleeves 62, 64 can help maintain the sealant in the closure system 20 as the closure system 20 is retracted through the arteriotomy. The slit design of the distal section 60 reduces friction during deployment of the sealant and reduces the risk of clogging the sealant. For example, if the sealant 18 begins to expand while still positioned in the closure system 20 (e.g., due to bodily fluids entering from the distal end), the slit design of the distal section 60 provides space for the sealant 18 to expand without clogging the closure system 20.

[0052] Figures 9A-9G A second embodiment of a closure system 120 is shown. In this embodiment, the closure system 120 may include one or more actuators that facilitate deployment of the sealant, compaction of the sealant, and retraction of the expandable structure, and specifically, three actuators. Figures 1A-1I Like features to those of the first embodiment shown and discussed above have like reference numerals.

[0053] Similar to Figure 1B The closure system 20 in FIG. 1 may be introduced through the procedure sheath 10 (see FIG. 1 ) by introducing the outer catheter 22 through the hub portion 14. Fig. 9A ). The outer catheter 22 may be sized to be compatible with a standard procedure sheath of 5F or larger.

[0054] The closure system 120 may be advanced through the procedure sheath 10 until the sheath adapter 40 engages the hub portion 14 of the procedure sheath 10. As described in further detail below, the sheath adapter 40 may be designed to removably engage the side port 16 of the hub portion 14 or the flush line 12.

[0055] Similar to the first embodiment proposed above, the inner catheter 24 can extend through the outer catheter 22. The inner catheter 24 can include an expandable structure 26 positioned at the distal section of the inner catheter 24, such as a balloon or other suitable element, as discussed above. The inner catheter 24 can be, for example, by actuating or depressing the first actuator 32 to release the inner catheter 24 from the outer catheter 22 and by actuating or depressing the third actuator 36 to move the inner catheter 24 into the support member 28, relative to the outer catheter 22 along the axial movement. In order to provide compatibility with the existing procedure sheath, the sheath of the closed system is integrated with the device handle. This can be achieved by providing an inner sleeve 64 and an outer sleeve 62, which form an inner / outer sleeve assembly, for example, two sleeves at the distal end. The integrated sheath (for example, the outer catheter 22) can be fixed to the handle and retracted during the sealant deployment. The outer catheter 22 can move radially in the handle to minimize the influence of torsional forces on the outer catheter 22 and the outer sleeve 62; This can allow the outer sleeve 62 / catheter 22 to rotate freely in the handle.

[0056] With the closure system 120 coupled to the procedure sheath 10, the expandable structure 26 of the inner catheter 24 may be expanded using the syringe 50 (see Fig. 9B ). The inflatable structure 26 may be inflated until the inflation indicator 154 indicates that the inflatable structure 26 is inflated to a predetermined pressure. For example, the inflation indicator 154 may move from the first position to the second position when the inflatable structure 26 is fully inflated. Fig. 9B , the inflation indicator 154 in the second position may protrude from the proximal end of the handle portion 130; however, the inflation indicator 154 may be positioned elsewhere on the handle portion 130. After the inflatable structure 26 is inflated, the inflation line 56 may be sealed by closing the valve 52. With the inflatable structure 26 inflated, the closure system 120 and the procedure sheath 10 may be retracted until the inflatable structure 26 abuts the inner surface of the vessel wall V.

[0057] The inner catheter 24 can be released from the outer catheter 22 by actuating or depressing the first actuator 132. When the inner catheter 24 is released, the procedure sheath 10 and the outer catheter 22 can also be retracted relative to the inner catheter 24 to expose the sealant 18 by retracting the handle and the procedure sheath simultaneously (see Fig. 9C ). In this configuration, the handle portion 130 slides over the first actuator 132 to retract the outer catheter 22 while the inner catheter 24 remains in place. When the first actuator 132 is depressed and the handle body 130 slides rearwardly, the visual indication 180 becomes visible through the window 182, which is exposed when the handle 130 is slid proximally over the first actuator 132 to display an image indicating whether the sealant is properly deployed.

[0058] With the sealant 18 exposed, the support member 28 may be advanced to tamp the sealant 18 against the outer surface of the vessel wall V. Actuation or depression of the second actuator 134 may advance the support member 28 relative to the inner catheter 24 and the outer catheter 22. Additionally, the visual indicator 180 visible through the window 182 may display different images indicating the successful completion of the tamp of the sealant and the beginning of the dwell period for sealant activation.

[0059] After the second actuator 134 is depressed, but before the third actuator 136 is depressed, the inflation indicator 154 may provide a lockout feature that prevents the third actuator 136 from being depressed when the inflatable structure 26 is in the inflated configuration (see FIG. Fig.9E ). The inflation indicator 154 can extend through the proximal portion of the handle 130 so that the distal portion of the inflation indicator 154 is positioned below the third actuator 136. When the inflation indicator 154 is in the second position (e.g., extending beyond the proximal end of the handle 130), this not only indicates that the inflatable structure 26 is inflated, but also provides a blocking segment 140 that is integrated with the inflation indicator 154 but inside the handle body.

[0060] After the sealant 18 has been tamped, the inflatable structure 26 may be deflated, for example, by opening the valve 52 and deflating the inflatable structure 26 using the syringe 50 (see FIG. Fig.9F ). In the event that the inflatable structure 26 is deflated, the inflatable structure 26 may be retracted through the sealant 18 by actuating the third actuator 136. The inner catheter 24 may be retracted relative to the outer catheter 22 and / or the support member 28 (see Figure 9G ). After the expandable structure 26 is retracted through the sealant 18, the entire closure system 20 and procedure sheath 10 can be removed from the body, leaving the sealant 18 in place against the vessel wall V. Since the sheath adapter 40 is coupled to the procedure sheath 10, the closure system 20 and procedure sheath 10 can be removed together, but the closure system 20 can be detached from the procedure sheath 10 and removed separately.

[0061] Now turn to Figures 10A-13B , further details of the handle portion 130 of the closure system 120 are shown. The interior of the handle 130 houses the proximal 142 and distal 144 slide plate assemblies, which slide or glide within the interior of the handle when actuated, such as Figures 10A-10B The distal slide assembly 144 may be integrated with the first actuator 132 so that when the first actuator is depressed and the handle is retracted, the distal slide assembly moves distally relative to the handle, as shown in FIG. Fig. 10B. The proximal 142 and distal 144 slide assemblies are in a locked position relative to the handle 130 until the first actuator 132 is fully depressed and locked into a second depressed position. When the first actuator 132 is depressed, both the distal slide assembly 144 and the proximal slide assembly 142 are unlocked and can move distally relative to the handle body 130 when the handle is retracted. The proximal slide assembly 142 can house the inner catheter 24 and the inflation indicator.

[0062] Steering Fig. 10C , a close up view of device 120 is shown attached and locked with a procedure sheath at catch 40. Sheath catch or adapter 40 may be oriented in any position or orientation, and alternatively may be provided so that it may be able to rotate about handle 130 so that it may be adjusted to more easily capture a port or flush line of a procedure sheath.

[0063] In addition to actuating the distal sled assembly, the first actuator 132 may also display a visual indication 180 through a window 182 that may provide a storyboard to the user to understand that the outer sleeve has been successfully retracted and the sealant has been deployed, such as Fig.11A - shown in C. Fig.11A A portion of a handle body 130 including a first actuator is shown, wherein the first actuator 130 may also optionally have a visual indication to identify it as the first actuator in a series of actuators. When the first actuator 132 is actuated or depressed, a first image or visual indication may become visible and, for example, a symbol (such as a check mark or other suitable symbol) may be displayed through the window 182 to indicate sealant deployment, such as Fig. 11B Once the second actuator 134 is also depressed, the storyboard may further display another image to convey that the sealant has been successfully tamped, such as Fig. 11C Although check marks and circles with symbols therein are shown, any visual indication or image may be used when appropriate to indicate a completed step.

[0064] like Figures 12A-12B, the second actuator 134 may include a cam drive mechanism that can drive a distal sled assembly 144 associated with the first actuator 132 and the support member 28 in a distal direction to tamp the sealant. The second actuator 134 may interface with a ramp 146 on the proximal end of the distal sled assembly 144 / first actuator 132, which may be overmolded onto the support member 28 so that any distal movement of the distal sled assembly 144 may also move the support member 28 in a distal direction. When the second actuator 134 is depressed, a distal side 148 of the second actuator 134 may contact the ramp 146 of the distal sled assembly 144, pushing it in a distal direction, and may cause the distal sled assembly 144 and the support member 28 to advance in a distal direction, causing the sealant to be compressed and tamped by the advancement of the support member 28.

[0065] The third actuator 136 can be depressed to cause the deflated inflatable structure 26 to retract rearwardly into the support member 28, as in Fig.13A and Fig. 13B In one aspect, as in Fig. 13C and Fig.13D As seen in yet another close-up interior view in FIG. 1 , retraction of the expandable structure 26 can be accomplished by an arm 150 extending from and below the top / outer surface of the third actuator 136. When the third actuator 136 is depressed, it can cause the arm 150 to engage the inner catheter 24, and when engaging the catheter, the arm can bend the inner catheter 24 on the proximal end so that it can bend the catheter 24 away from the central axis of the handle 130, as shown in FIG. Fig.13D As seen in FIG. 2 , it is retracted in the proximal direction, thereby retracting the expandable structure 26 into the support member 28.

[0066] In addition, if the inflatable structure 26 is in an inflated state, as indicated by the inflation indicator 154 (extending beyond the proximal end of the handle 130), the third actuator 136 cannot be depressed due to a locking feature. The locking feature is provided by a portion of the inflation indicator 154, which extends inwardly and distally into the handle 130 and also has a protrusion 140, which extends axially outward away from the central axis of the handle 130 and acts as a lock or stop to prevent the third actuator 136 from being depressed. When the inflatable structure 26 is deflated, the inflation indicator 154 can be shifted in the distal direction so that it is no longer visible proximal to the handle. This movement of the inflation indicator 154 can also shift the position of the protrusion 140 that locks the third actuator 136 in an appropriate position. Once shifted, the third actuator 136 is free to be depressed. This locking feature provided by the inflation indicator 154 is beneficial in preventing accidental depression of the third actuator 136 so that the expandable structure does not retract before being fully deflated. In an alternative aspect, the locking element can be a protrusion that extends axially toward the center of the handle 130 and locks the distal arm on the third actuator 136 so that the third actuator 136 cannot be depressed.

[0067] An alternative embodiment of the closure system 220 is Figures 14A-15D In this embodiment, the closure system 220 may include two actuators that assist in deploying the sealant, tamping, and retracting the expandable structure. Similar features to the first and second embodiments have similar reference numerals.

[0068] Similar to Figure 1B In order to function as the closure system 20 in the embodiment of the present invention, the closure system 220 can be introduced through a procedure sheath (not shown) by introducing the outer catheter 22 through the hub portion 14 (not shown). The outer catheter 22 can be sized to be compatible with a standard procedure sheath of 5F or larger.

[0069] As in Fig.14A As seen in the figure, handle 230 can include at least one actuator, and more specifically, two actuators. Although not shown, closure system 220 can also be advanced through the procedure sheath until sheath adapter 40 engages the hub portion of the procedure sheath, as in the previous embodiments. With respect to advancement through the procedure sheath and locking the handle to the procedure sheath via sheath adapter 40, closure system 220 can be performed in a manner similar to the previous embodiments.

[0070] Steering Fig.14A, handle 230 is shown with a first actuator 222 and a second actuator 224. The first actuator 222 may have a combined function of retracting the outer catheter 22 and tamping the sealant 18 when actuated. The second actuator 224 may have a function similar to the third actuators 36 and 136 from the previous embodiment. When the second actuator 224 is depressed, it may retract the expandable structure 26 into the support member or tube 28. Although Figures 14A-15D Only the closure device is shown, but the device can be used with Figure 1B-1I and Figures 9A-9G A similar approach as depicted in is employed to achieve the closure process in the arteriotomy.

[0071] In addition, if Fig. 14C As shown in FIG. 2 , the tension indicator 206 can be incorporated into the handle 230 design by including a tension indicator window 228 through which a graphic or image can be visible that indicates whether the appropriate tension is applied to the expandable structure 26 upon placement of the expandable structure 26 at the inner surface of the vessel wall V. The tension indicator 206 can provide a visual cue to the user when the appropriate amount of tension is applied to the expandable structure 26 prior to deploying the sealant 18. Knowing when the tension is appropriate is helpful because if too much tension is applied by the expandable structure 26 on the artery wall, it can cause the vessel to open (e.g., dilate), causing the artery to move out of its initial position (e.g., its original anatomical position) during the closure process. If the sealant 18 is deployed with the artery in this open position, when the artery returns to its normal position after the expansion structure 26 is deflated and the device 220 is removed from the patient, the compression of the tissue surrounding the open vessel can cause a slight separation of the hydrogel sealant 18 from the surface of the puncture site.

[0072] Steering Fig. 14B , showing an interior view of the handle 230. The handle 130 may have a proximal slide assembly 242 that can accommodate the inner catheter 24, similar to the other embodiments. When the expandable structure 26 is inflated in the patient's artery and pulled back to the arteriotomy, the expandable structure 26 may encounter resistance as it presses upward against the vessel wall, and the force applied to the expandable structure 26 may be transmitted back to the proximal slide assembly 242. The proximal slide assembly 242 can move in a distal direction when the expandable structure 26 is under tension, thereby compressing the tension spring 202 housed in the tension indicator 206. When the force on the expandable structure 26 exceeds the preload on the tension spring 202, the tension indicator 206 can begin to move in a distal direction. The first actuator 222 can be depressed when the protrusion or black line on the tension indicator 206 is located within or aligned with the appropriate tension area 226 on the device handle 230, showing the tension indicator 206 in a suitable position within the tension indicator window 228, as shown. Fig. 14C As shown in .

[0073] If the tension indicator 206 is not aligned with the appropriate tension region 226, the first actuator 222 may not be actuated or depressed because the tension applied to the inflatable structure 26 is not in the appropriate tension region (e.g., the black band). Therefore, the tension indicator region 226 may include a lockout feature that prevents the first actuator 222 from being depressed when inappropriate tension is applied via the inflatable structure 26. The tension region 226 may be indicated in any manner and may be Fig. 14C , it can be indicated by a black line marked on the handle assembly 230. The location of the black line on the handle 230 is positioned in the appropriate tension zone. The tension indicator 206 can be a slide inside the handle assembly 230 that can slide distally based on the tension applied to the inflatable structure 26. Therefore, to ensure that the correct tension is applied to the inflatable structure 26, the user can adjust the tension on the inflatable structure 26 until the black line on the tension indicator 206 is aligned with the black line on the handle of the tension zone 226. In one aspect, the tension can be adjusted by pulling back on the handle of the closure device or reducing its pressure, whichever is necessary. Alternatively, any other visual indication system can be used when appropriate to indicate the appropriate tension applied to the inflatable structure 26.

[0074] Steering Fig.15A -D, showing interior views of the handle housing, these views do not show the tension indicator 206, however, if desired, the tension indicator 206 may be included, such as Fig.14A - shown in C. Fig.15A The handle 230 is shown at rest (before the first actuator 222 is depressed). It can be seen that, in the rest position, the inner rib 212 on the first actuator 222 can engage or contact the ramp 214 on the pull frame 208. The pull frame 208 can be connected to the outer sleeve assembly 62 (not shown). Upon actuation or depression of the first actuator 222, the pull frame 208 can begin to translate in a proximal direction (e.g., away from the sheath adapter 40). As the pull frame 208 is translated in the proximal direction by actuation of the first actuator 222, the outer sleeve 62 also begins to translate in the proximal direction, thereby exposing the sealant in the tissue tract adjacent to the arteriotomy. Upon initial depression of the first actuator 222, such as in Fig. 15B During this time, the sealant may begin to be exposed by retraction of the sleeve.

[0075] When the first actuator 222 is partially depressed, as in Fig. 15BDuring the movement of the puller frame 208, the distal side 218 of the first actuator 222 can engage the pusher frame 210 and can begin to translate the pusher frame 210 in a distal direction (e.g., toward the sheath adapter 40) at a point where the sealant is at least partially exposed (and in one aspect, about 50% exposed). The pusher frame 210 can be connected to the support member 28 or the tamping tube so that as the pusher frame 210 translates in the distal direction, it also translates the support member 28 in the distal direction, effectively tamping the sealant against the vessel wall of the arteriotomy. After about 50% of the sealant is exposed by the movement of the puller frame 208 (e.g., when the first actuator is initially depressed), both the pusher frame 210 and the puller frame 208 can move simultaneously or relatively simultaneously in their respective directions, exposing the sealant and tamping the sealant. Preferably, at least a portion of the sealant is exposed prior to tamping; this can help alleviate clogging of the sleeve and / or sealant. In this embodiment, approximately 50% of the sealant is exposed prior to engagement of the pusher frame 210 , however, any other suitable amount of sealant may be exposed that is less than or greater than 50% prior to engagement of the pusher frame 210 .

[0076] exist Fig. 15C In FIG. 1 , the pulling frame 214 is shown in its final position, having been translated proximally to its starting position, while the pushing frame 216 is shown in its final position, having been translated distally to its starting position. Fig.15D The first actuator 222 is shown fully depressed, with the ramp 216 on the push frame 210 exposed inside the handle 230. The first actuator 222 or a combination actuator can drive the pull frame 208 and the push frame 210 using a cam drive mechanism similar to the previous embodiments. The first actuator 222 can include features that engage with each frame and can drive them in the desired direction.

[0077] Although not shown, depressing the second actuator 224 can cause the inflatable structure 26 to retract, similar to how the third actuator functions in the previous embodiment, and can further include a lockout mechanism that prevents the second actuator 224 from being depressed while the inflatable structure 26 is still inflated (as indicated by the inflation indicator 254). This lockout feature is similar to the lockout feature described above with respect to the second embodiment, having a blocking segment or protrusion 140 extending from the proximal slide assembly, and as shown in FIG. Fig. 10A , as shown in 10B, 13A and 13B.

[0078] This embodiment shows a handle device 230 with two actuators, however, the handle may have more or fewer actuators than described herein. For example, the handle may be provided with only one actuator that performs all of the functions described herein, or one actuator that performs one or more functions and uses another approach for any remaining functions. Thus, a handle on a closure device may have one or more actuators when appropriate.

[0079] Figure 3 An enlarged view of a sheath adapter 40 is shown that can engage any sheath having a side port or flush line. The sheath adapter 40 can be integrated with the handle portion 30 or a separate component coupled to the handle portion 30, either directly or via an interposed catheter shaft or other attachment structure.

[0080] like Figure 3 As shown in FIG. 1 , the sheath adapter 40 may have any suitable shape, and in particular may have a generally tubular, cylindrical, or generally frustoconical shape. The sheath adapter 40 may include polycarbonate, ABS, silicone, elastomer, or other suitable material. The elastic material may be beneficial in enabling the sheath adapter 40 to clamp the side port 16 or flush line 12 of the sheath 10.

[0081] Sheath adapter 40 may include an attachment structure that may be releasably attached to the procedure sheath, such as a bayonet connector or a hook portion 42 that may hook around a lateral retaining surface, such as a distal-facing surface on side port 16 or flush line 12 of procedure sheath 10. Hook portion 42 may form a passage 44 that may guide side port 16 or flush line 12 into engagement with sheath adapter 40. Hook portion 42 may be shaped such that both axial and rotational movement are required to disengage hook portion 42 from sheath 10.

[0082] Passage 44 can be defined by distal edge 48a, outer lateral edge 48b, proximal edge 48c, inner lateral edge 48d, and hook end edge 48e. The edge defining passage 44 can be substantially straight or curved. Distance D1 between distal edge 48a and hook end edge 48e can be sized to allow side port 16 or flush line 12 to enter passage 44. For example, distance D1 can be within about 10% or about 20% of the diameter of side port 12 or flush line 12, which can be between about 3F and about 11F, such as between about 3F and about 6F, between about 5F and about 8F, or between about 7F and 10F, including about 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, or 11F.

[0083] Distance D1 may be less than distance D2 between distal-facing edge 48a and proximal-facing edge 48c (less than approximately 60% of D2, less than approximately 50% of D2, less than approximately 40% of D2, less than approximately 30% of D2, less than approximately 20% of D2, or more).

[0084] The distance D3 between the outer lateral edge 48b and the inner lateral edge 48d can be sized to receive the side port 16 or the flush line 12 of the procedure sheath 10. For example, the distance D3 can be within 10% of the diameter of the side port 16 or the flush line 12, which can be between about 3F and about 11F, such as between about 3F and about 6F, between about 5F and about 8F, or between about 7F and 10F, including about 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, or 11F. The distance D3 can be less than the distance D1.

[0085] The inner lateral edge 48d can have a length suitable for blocking the side port 16 or the flush line 12 from disengaging from the sheath adapter 40 when the closure system 20 is rotated. For example, the length of the inner lateral edge 48d can be at least as long as the diameter of the side port 16 or the flush line 12. The length of the inner lateral edge 48d can be at least about 20% of the length L of the sheath adapter 40, at least 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 can be at least as long as the distance D3.

[0086] Although not shown, in some embodiments, the distance D3 can narrow from the proximal-facing edge 48c toward the hook end edge 48e. The hook portion 46 can be spring-like and move away from the outer lateral edge 48b to expand the distance D3 between the outer lateral edge 48b and the inner lateral edge 48d to allow the side port 16 or the flushing line 12 to move toward the proximal-facing edge 48c. The hook portion 46 can rebound back toward the outer lateral edge 48b to retain the side port 16 or the flushing line 12.

[0087] Figure 4 Shown is an enlarged view of another sheath adapter 70 that may be used with the closure system 20 to engage any sheath having a side port or flush line. The sheath adapter 70 may be integrated with the handle portion 30 or a separate component coupled thereto.

[0088] like Figure 4 As shown in FIG. 1 , the sheath adapter 70 may have a generally cylindrical or generally frustoconical shape. The sheath adapter 70 may include polycarbonate, ABS, silicone, elastomer, or other suitable material. The elastic material may be beneficial in enabling the sheath adapter 70 to clamp the side port 16 or flush line 12 of the sheath 10.

[0089] The sheath adapter 70 may include an attachment structure (e.g., a bayonet connector) that can be releasably attached to the procedure sheath. For example, the attachment structure may include a first hook portion 72 having a first hook end portion 72a, and a second hook portion 74 having a second hook end portion 74a. At least a portion of the first hook portion 72 and the second hook portion 74 may extend distally beyond a distal-facing edge 76 of the remainder of the sheath adapter 70.

[0090] The first hook portion 72 and the second hook portion 74 may be generally the same shape and size, but inverted relative to each other such that lower surfaces 72b, 74b of the first hook portion 72 and the second hook portion 74 taper inwardly and toward each other to direct the side port 16 or flush line 12 toward the passageway 78. The sheath adapter 70 may be generally symmetrical across a plane extending between the first hook portion 72 and the second hook portion 74 and extending through a longitudinal axis of the sheath adapter 70.

[0091] The distance B1 between the first hook end portion 72a and the second hook end portion 74a can be less than the diameter of the side port 16 or flushing line 12 to prevent the side port 16 or flushing line 12 from being unintentionally separated from the sheath adapter 70. The hook ends 72a, 74a can bend to expand the distance B1 to allow the side port 16 or flushing line 12 to enter the passage 78, but once the side port 16 or flushing line 12 is in the passage 78, it rebounds so that the side port 16 or flushing line 12 is retained between the hook ends 72a, 74a and the distally facing edge 78d. The spring-like hook ends 72a and 74a can be designed to retain the side port 16 or flushing line 12 under normal use, but can be overcome by the user if separation of the sheath adapter 70 is necessary.

[0092] Each hook portion 72, 74 can define a portion of a passage 78. Each hook portion 72, 74 can have an inner lateral edge 78a, a proximally facing edge 78b, an outer lateral edge 78c, and a distally facing edge 78d. The edges defining the passage 78 can be generally straight or curved.

[0093] The distance B2 between the inner lateral edge 78a and the outer lateral edge 78c may be sized to allow for the necessary bending of the hook portions 72 , 74 toward their respective outer lateral edges 78c to allow the side port 16 or flush line 12 to enter the passageway 78 .

[0094] Figure 5 An enlarged view of another sheath adapter 80 that can be used with the closure system 20 to engage any sheath having a side port or flush line is shown. The sheath adapter 80 can be integrated with the handle portion 30 or a separate component coupled to the handle portion 30. Figure 5As shown in FIG. 8 , the sheath adapter 80 may include a proximal flange 82 to engage the handle portion 30 .

[0095] like Figure 5 As shown in FIG. 1 , the sheath adapter 80 may have a generally cylindrical or generally frustoconical shape. The sheath adapter 80 may include polycarbonate, ABS, silicone, elastomer, or other suitable material. The elastic material may be beneficial in enabling the sheath adapter 40 to clamp the side port 16 or flush line 12 of the sheath 10.

[0096] The sheath adapter 80 can include an attachment structure that can be releasably attached to a procedure sheath, such as a bayonet connector or a hook portion 84. A distally facing edge 88 of the sheath adapter 80 can extend distally beyond the hook portion 84.

[0097] The hook portion 84 can form a passage 86. The passage 86 can be defined by a hook end edge 86a, a proximal facing edge 84b, a first inner lateral edge 86c, a first distal facing edge 86d, a second inner lateral edge 86e, a second distal facing edge 86f, and an outer lateral edge 86g. The edges defining the passage 86 can be generally straight or curved.

[0098] The hook end edge 86a may be tapered inwardly toward the passage 86 to guide the side port 16 or flush line 12 toward the passage 86. The distance C1 between the hook end edge 86a and the outer lateral edge 86g may be sized to prevent the side port 16 or flush line 12 from inadvertently leaving the passage 86. The hook portion 84 may be a spring member that may deflect away from the central axis of the sheath adapter 80 to expand C1 to allow the side port 16 or flush line 12 to pass into the passage 106. After the side port 16 or flush line 12 is positioned in the channel 86, the hook portion 84 may return to its initial state so that the side port 16 or flush line 12 is retained between the proximal facing edge 86b and the second distal facing edge 86f.

[0099] The second distal facing edge 86e can be proximal to the first distal facing edge 86c and spaced apart from the first distal facing edge 86c by a second inner lateral edge 86e. The second distal facing edge 86e can be generally curved to direct the side port 16 or flush line 12 toward the inner lateral surface 86c. The distance C2 between the second inner lateral edge 86e and the outer lateral edge 86g can be greater than the distance C1 and be sized to receive the side port 16 or flush line 12. In one aspect, C1 can be approximately 0.126 inches and C2 can be approximately 0.210 inches, however, other suitable dimensions are possible.

[0100] The length of the proximal facing edge 86b and / or the first distal facing edge 86d may be sufficient to enable the hook portion 84 to deflect outward and expand the distance C1 to allow passage of the side port 16 or the flushing line 12. For example, the proximal facing edge 86b and / or the first distal facing edge 86d may extend around at least 20% of the circumference of the sheath adapter 80, at least approximately 30% of the circumference of the sheath adapter, at least approximately 40% of the circumference of the sheath adapter, or at least approximately 50% of the circumference of the sheath adapter 80. The length of the proximal facing edge 86b may be longer than the length of the first distal facing edge 86d.

[0101] Alternatively, the distance C3 of the proximal facing edge 86b to the first distal facing edge 86d may be sized to allow the side port 16 or flush line 12 to traverse the passage 86. The distance C3 may be within 10% or approximately 20% of the diameter of the side port 16 or flush line 12. The distance C3 may be less than the distance C1.

[0102] Figure 6 An enlarged view of another sheath adapter 90 that can be used with closure system 20 to engage any sheath having a side port or flush line is shown. In many respects, sheath adapter 90 is similar to sheath adapter 80 discussed above. Therefore, the references used to identify features of sheath adapter 80 are increased by a factor of ten (10) to identify similar features of sheath adapter 90.

[0103] Unlike sheath adapter 80, hook end edge 96a of sheath adapter 90 is generally straight, and a distal section of outer lateral edge 96h may be tapered inwardly to guide side port 16 or irrigation line 12 into passageway 96. The distal section of outer lateral edge 96h and the proximal section of outer lateral edge 96g are separated by a proximally facing step 96i.

[0104] The sheath adapter 90 may include a protrusion or thumb grip 91 extending radially outward from the sheath adapter 90 that allows a user to bend the hook end 96 a outwardly away from the central axis of the sheath adapter 90 to expand the distance C1 and enable removal of the sheath 10 from the sheath adapter 90 .

[0105] Figure 7 An enlarged view of another sheath adapter 100 that can be used with the closure system 20 to engage any sheath having a side port or flush line is shown. The sheath adapter 100 can be integrated with the handle portion 30 or a separate component coupled to the handle portion 30. Figure 7, sheath adapter 100 may include a proximal flange 102 to engage handle portion 30. Proximal flange 102 may have a detent feature that allows the user to rotate sheath adapter 100 for optimal positioning to accommodate side ports positioned at various angles, but prevents rotation of sheath adapter 100 during the procedure.

[0106] like Figure 7 10, sheath adapter 100 may include an attachment structure, such as a bayonet connector or a hook portion 104, that may be releasably attached to a procedure sheath. Hook portion 104 may protrude radially outward from sheath adapter 100. Hook portion 104 may be shaped such that axial and rotational movement is required to disengage sheath adapter 100 from sheath 10. Alternatively, hook portion 104 may be configured such that it must be depressed to disengage sheath adapter 100 from sheath 10.

[0107] The hook portion 104 can form a passage 106. The passage 106 can be defined by a lower hook edge 106a, a hook end edge 106b, an upper hook edge 106c, an inner lateral edge 106d, a distally facing edge 106e, and an outer lateral edge 106f. The edges defining the passage 106 can be generally straight or curved. The lower hook edge 106a can be generally tapered inwardly to guide the side port 16 or the flush line 12 toward the passage 106.

[0108] The distance E1 between the hook end edge 106b and the outer lateral edge 106f can be sized to prevent the side port 16 or the flush line 12 from inadvertently escaping the passage 106. The hook portion 104 can be a spring member that can deflect toward the inner lateral edge 106d to reduce E3 and increase E1 to allow the side port 16 or the flush line 12 to pass into the passage 106. After the side port 16 or the flush line 12 is positioned in the passage 106, the hook portion 104 can return to its initial state so that the side port 16 or the flush line 12 is retained between the distal-facing edge 106e and the hook end edge 106b.

[0109] The length of the upper hook edge 106c can be sufficient to enable the hook portion 84 to deflect toward the medial edge 106d and allow the side port 16 or the flush line 12 to pass into the passage 106. The length of the upper hook edge 106c can be long enough to enable the hook end edge 106 to facilitate retention of the side port 16 or the flush line 12 and inhibit the sheath 10 from being easily disengaged from the sheath adapter 100 when the closure system is rotated or pulled. For example, the length of the upper hook edge 106c can be at least about 20% of the length L of the sheath adapter 100, at least about 30% of the length L of the sheath adapter 100, or at least about 40% of the length L of the sheath adapter 100.

[0110] The distal facing edge 106e can be generally curved to direct the side port 16 or flush line 12 between the upper hook edge 106c and the inner lateral edge 106d toward the portion of the passageway 106. The distance E2 between the inner lateral edge 106d and the outer lateral edge 106f can be greater than the distance E1. In one aspect, E1 can be approximately 0.115 inches and E2 can be approximately 0.210 inches, however, other suitable dimensions may be possible.

[0111] Figure 8 Another sheath adapter 110 is shown that can engage any sheath having a side port 16 or flush line 12. The sheath adapter 110 can be integral with the handle portion 30 or include a proximal flange 112 to engage the handle portion 30.

[0112] like Figure 8 As shown in FIG. 1 , the sheath adapter 110 may have a generally cylindrical or generally frustoconical shape. The sheath adapter 110 may include polycarbonate, ABS, silicone, and elastomer or other suitable materials. The elastic material may be beneficial in enabling the sheath adapter 110 to clamp the side port 16 or flushing line 12 of the sheath 10.

[0113] The sheath adapter 110 may include an attachment structure that may be releasably attached to the procedure sheath, such as a bayonet connector or a hook portion 114 that may be hooked around the side port 16 or the irrigation line 12 of the procedure sheath 10. The hook portion 116 may extend distally beyond a distal edge 118 of the remainder of the sheath adapter 110. The hook portion 114 may form a passage 116 to retain the side port 16 or the irrigation line 12. The hook portion 114 may be shaped such that both axial and rotational movement are required to disengage the hook portion 114 from the sheath 10.

[0114] The passage 116 may be defined by an outer lateral edge 116a, a proximal facing edge 116b, and an inner lateral edge 116c. The edges defining the passage 116 may be generally straight or curved. The distance F1 between the outer lateral edge 116a and the inner lateral edge 116c may be sized to allow the side port 16 or the flush line 12 to enter the passage 116. For example, the distance F1 may be within about 10% or about 20% of the diameter of the side port 12 or the flush line 12. In one aspect, F1 may be about 0.200 inches, however, other suitable sizes are possible.

[0115] In some embodiments, the distance F1 can narrow from the proximal-facing edge 116b toward the hook end edge 116d. The hook portion 114 can be spring-like and move away from the inner lateral edge 116c to expand the distance D1 between the outer lateral edge 116a and the inner lateral edge 116c to allow the side port 16 or the flushing line 12 to move toward the proximal-facing edge 116b. The hook portion 114 can rebound back toward the inner lateral edge 116c to hold the side port 16 or the flushing line 12.

[0116] Although not shown, any of the sheath adapter embodiments may include barbs, threads, flanges, or other features to facilitate engagement with the sheath 10, such as a snap fit or friction fit. These features may be used to engage the outer or inner surface of a side port, flush line, or procedure sheath hub. The addition of any of these features may also be used to permanently couple any of the sheath adapters described above with the sheath 10.

[0117] term

[0118] As used herein, the relative terms "proximal" and "distal" will be defined from the perspective of the closure system. Thus, proximal refers to the direction of the handle of the closure system, while distal refers to the direction of the distal tip of the closure system.

[0119] Unless expressly stated otherwise, or otherwise understood in the context of use, conditional language used herein, such as, among other things, "may," "could," "can," "might," "for example," and the like, is generally intended to convey that certain embodiments include and other embodiments do not include certain features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way essential to one or more embodiments, regardless of whether such features, elements, and / or steps are included or will be performed in any particular embodiment.

[0120] The terms "comprising," "including," "having," etc. are synonymous and are used inclusively in an open-ended manner and do not exclude additional elements, features, actions, operations, etc. Furthermore, the term "or" is used in its inclusive sense (and not in its exclusive sense) so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list.

[0121] As used herein, the terms "approximately," "about," and "substantially" refer to an amount that is close to the recited amount and still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount that is within less than 10% of the recited amount, as the context may dictate.

[0122] The ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," "between," and the like includes the stated numbers. Numbers preceded by a term such as "about" or "approximately" include the stated numbers. For example, "about 10%" includes "10%."

[0123] Any method disclosed herein does not need to be performed in the order in which it is presented. The methods disclosed herein include certain actions taken by the practitioner; however, they may also include, explicitly or implicitly, any third-party instructions for these actions. For example, an action such as "tamp the sealant" includes "instruct the tamping of the sealant".

[0124] Although certain embodiments and examples are described herein, it will be appreciated by those skilled in the art that many aspects of the closed systems shown and described in this disclosure may be combined and / or modified in various ways to form yet other embodiments or acceptable examples. All such modifications and variations are intended to be included within the scope of this disclosure. Various designs and approaches are possible. The features, structures, or steps disclosed herein are not necessary or indispensable.

[0125] Some embodiments are described in conjunction with the accompanying drawings. However, it should be understood that the drawings are not drawn to scale. Distances, angles, etc. are illustrative only and do not necessarily have an exact relationship to the actual size and layout of the device shown. Components may be added, removed, and / or rearranged. In addition, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. in conjunction with the various embodiments may be used in all other embodiments set forth herein. In addition, it will be appreciated that any method described herein may be practiced using any device suitable for performing the stated steps.

[0126] For purposes of the present disclosure, certain aspects, advantages, and novel features are described herein. It will be understood that not all such advantages may be achieved according to any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be implemented or performed in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0127] In addition, although illustrative embodiments are described herein, the scope of any and all embodiments with equivalent elements, modifications, omissions, combinations (e.g., across aspects of the various embodiments), adaptations, and / or alterations is based on the present disclosure, as will be recognized by those skilled in the art. The limitations in the claims are to be interpreted broadly based on the language employed in the claims, and are not limited to the examples described in this specification or during the examination of the application, which examples are to be interpreted as non-exclusive. In addition, the actions of the disclosed processes and methods may be modified in any way, including by reordering actions and / or inserting additional actions and / or deleting actions. Therefore, it is intended that the description and examples be considered illustrative only, with the true scope and spirit being indicated by the full scope of the claims and their equivalents.

Claims

1. A closure system for closing an arteriotomy, the closure system comprising: Handle part; an outer catheter extending from the handle portion, the outer catheter comprising a proximal section and a distal section, the distal section comprising an inner sleeve and an outer sleeve surrounding the inner sleeve, the inner sleeve comprising a first slit, the outer sleeve comprising a second slit, the second slit being circumferentially displaced from the first slit; an inner conduit extending through the outer conduit, the outer conduit being axially movable relative to the inner conduit; a sealant capable of swelling from exposure to body fluids, the sealant being positioned in the distal section of the outer catheter, wherein the sealant is circumferentially surrounded by the overlapping combination of the inner sleeve and the outer sleeve; and a support tube proximal to the sealant and radially between the outer catheter and the inner catheter, Wherein, the inner sleeve is fixed to the outer sleeve near the first slit and the second slit.

2. The closure system according to claim 1, wherein: The outer catheter is circumferentially continuous in the proximal section, and the slit of the outer sleeve is a longitudinal slit that extends the length of the distal section.

3. The closure system of claim 1, wherein: The proximal section of the outer catheter comprises a single layer.

4. The closure system of claim 1, wherein: The first slit is circumferentially displaced from the second slit by approximately 180 degrees.

5. The closure system of claim 1, wherein: The first slit and the second slit are distal to the support tube prior to deployment.

6. The closure system of claim 1, wherein: The handle portion also includes a first actuator mechanism attached to the handle portion, the first actuator mechanism being actuatable to move the outer catheter in a proximal direction and the support tube in a distal direction.

7. The closure system of claim 1, wherein: The inner catheter includes an expandable structure positioned at a distal section of the inner catheter.

8. The closure system of claim 7, wherein: The handle portion also includes a second actuator mechanism that is actuatable to retract the expandable structure in a proximal direction.

9. The closure system according to claim 8, wherein: The handle portion also includes a lockout mechanism to prevent depression of the second actuator mechanism when the expandable structure is in the inflated state.

10. The closure system of claim 1, further comprising a sheath adapter including attachment structure for releasably attaching to a procedure sheath.

11. The closure system of claim 10, wherein: The sheath adapter includes a proximal flange configured to engage the handle portion.

12. The closure system of claim 10, wherein: The sheath adapter and the handle portion are integrated.

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