US20230070873A1 - Apparatus and method for sealing a vascular puncture - Google Patents

Abstract

A closure system for delivering a sealant to an arteriotomy. A distal section of the closure system can include overlapping inner and outer sleeves that can expand with expansion of the sealant. A proximal section of the closure system can include a handle portion and a sheath adapter extending from the handle portion. The handle portion can comprise one or more actuators that when depressed or engaged can assist in deployment of the sealant in the 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 or an irrigation line 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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation of U.S. patent application Ser. No. 14/941,222 filed Nov. 13, 2015, which claims priority to U.S. Provisional Patent Application No. 62/079,878 filed Nov. 14, 2014. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
FIELD
• Percutaneous apparatuses and methods for sealing a vascular puncture using a plug or sealant.
BACKGROUND
• To obtain percutaneous access to a patient's vasculature, a hollow needle may be inserted through a patient's skin and into a blood vessel. A guide wire may be passed through the needle lumen into the blood vessel, whereupon the needle may be removed. An introducer sheath may then be advanced over the guide wire into the vessel in conjunction with or subsequent to one or more dilators. A catheter or other device may be advanced through the introducer sheath and over the guide wire into a position for performing a medical procedure. Upon completing the procedure, the device(s) and introducer sheath may be removed, leaving a puncture extending between the skin and the vessel wall. To seal the puncture, external pressure may be applied to the overlying tissue, e.g., manually and/or using sandbags, until hemostasis occurs.
• After completion of a diagnostic or therapeutic procedure requiring access to the vasculature (e.g., imaging procedure, angioplasty, stent delivery, or otherwise), the arteriotomy can be closed by various mechanical or biological solutions, such as by applying external pressure, cinching, suturing, and/or delivering metal implants, plugs, or sealants. However, many of these closure procedures may be time consuming, expensive, and uncomfortable for the patient, requiring the patient to remain immobilized in the operating room, catheter lab, or holding area for long periods of time. Additionally, some of these prolonged closure procedures may increase the risk of hematoma from bleeding prior to hemostasis.
• Some closure procedures may require a sheath exchange between the introducer sheath used during the diagnostic or therapeutic procedure and a sheath that is compatible with the closure system. This additional step may be time consuming and increases the risk of vessel injury and infection. Accordingly, there is still a need for a closure method that eliminates the sheath exchange step. The present disclosure is directed toward a closure system that is compatible with a standard procedural sheath and integrates the standard procedural sheath into a sealant delivery method.
SUMMARY
• Certain aspects of the disclosure are directed toward methods and closure systems for sealing an arteriotomy. The closure system can be introduced through a standard procedural sheath and can include a sheath adapter configured to engage the procedural sheath, particularly a side port or an irrigation line of the procedural sheath.
• Introducing the closure system through the existing procedural sheath eliminates the need for a custom sheath as well as eliminating the steps associated with a sheath exchange, including insertion of a guidewire, removing the existing sheath and inserting the custom sheath. Elimination of sheath exchange reduces risk of arterial trauma and vessel damage, maintains arterial access, saves time, limits leakage and bleeding and minimizes the possibility of hematoma or infection. In order to eliminate the need for a custom sheath, an integrated sheath can be provided within the closure system and can be comprised of two sleeves, an inner and an outer sleeve.
• In certain aspects, the method can include advancing a closure system through a procedural sheath extending through the arteriotomy. The method can also include securing the sheath adapter of the closure system to the procedural sheath by releasably attaching the attachment structure of the sheath adapter to a side port or an irrigation line of the procedural sheath, and retracting the handle portion to retract the procedural sheath and the outer catheter relative to the inner catheter to expose the sealant. The method can further include tamping the sealant with the support tube member.
• 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 an attachment structure for releasable attachment to a procedural sheath.
• In certain aspects, the closure system can include an outer catheter extending from a handle portion. The outer catheter can include a proximal section and a distal section. The distal section can include an inner sleeve and an outer sleeve surrounding the inner sleeve. The inner sleeve can include a first slit, and the outer sleeve can include a second slit circumferentially displaced from the first slit. The slit in the outer sleeve or primary sleeve can be provided to mitigate jamming of the sleeve/sealant and to ease friction as the sleeve is retracted during sealant delivery. The inner sleeve or secondary sleeve can be provided to help contain the sealant when the tip of the catheter is introduced into the vessel.
• Optionally, any of the closure systems described above can include an inner catheter extending through an 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.
• In certain aspects, the closure system can include a first actuator configured to unlock the inner catheter with respect to the handle. The handle can include a second actuator configured to advance a support tube or member through the procedural sheath to help tamp the deployed sealant. For example, the handle can include a cam drive mechanism, the cam can be linked to the second actuator and configured to cause the support member to move. In certain aspects, the handle can further include a third actuator configured to retract the expandable structure through the sealant. The third actuator can be a retraction slider that moves relative to the inner housing portion.
• In an alternative embodiment, the closure system can comprise a first actuator that is configured to both retract the outer sleeve, thus at least partially exposing the sealant, and to tamp the sealant against the arteriotomy. A second actuator can be provided to retract the expandable structure.
• A closure system that comprises a handle that has at least one actuator or other type of controller mechanism that can reveal the sealant, tamp the sealant and/or retract the expandable structure is provided herein. In another embodiment, a closure system that comprises a handle having at least two actuators or any other type of controller mechanism that can reveal the sealant, tamp the sealant and retract the expandable structure, alone or in any combination thereof. In yet another embodiment, a closure system is provided that comprises a handle having at least three actuators or any other type of controller mechanism that can reveal the sealant, then tamp the sealant and finally retract the expandable structure.
• Any feature, structure, or step disclosed herein can be replaced with or combined with any other feature, structure, or step disclosed herein, or omitted. Further, for purposes of summarizing the disclosure, certain aspects, advantages, and features of the devices have been described herein. It is to be understood that not necessarily any or all such advantages are achieved in accordance with any particular embodiments disclosed herein. No individual aspects of this disclosure are essential or indispensable.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS.1A-1I illustrate a method of using an embodiment of a closure system for delivering a sealant to an arteriotomy site.
• FIG.2 illustrates an enlarged view of a distal portion of the closure system shown inFIG.1B taken through line2-2.
• FIG.3 illustrates an enlarged view of a sheath adapter of the closure system shown inFIG.1C taken through line3-3.
• FIG.4 illustrates another embodiment of a sheath adapter that can be used with the closure system shown inFIGS.1A-1I.
• FIG.5 illustrates another embodiment of a sheath adapter that can be used with the closure system shown inFIGS.1A-1I.
• FIG.6 illustrates another embodiment of a sheath adapter that can be used with the closure system shown inFIGS.1A-1I.
• FIG.7 illustrates another embodiment of a sheath adapter that can be used with the closure system shown inFIGS.1A-1I.
• FIG.8 illustrates another embodiment of a sheath adapter that can be used with the closure system shown inFIGS.1A-1I.
• FIGS.9A-9G illustrate a method of using a second embodiment of a closure system for delivering a sealant to an arteriotomy site.
• FIGS.10A-10B illustrate an interior section close-up of a first actuator of the handle device shown inFIGS.9A-9G.
• FIG.10C illustrates a close-up view of a distal end of the handle device shown inFIGS.9A-9G.
• FIGS.11A-C illustrate one aspect of a visual indication system on the handle shown inFIGS.9A-9G.
• FIGS.12A-12B illustrate an interior section close-up of a second actuator of the handle device shown inFIGS.9A-9G.
• FIGS.13A-13D illustrate an interior section close-up of a third actuator of the handle device shown inFIGS.9A-9G.
• FIG.14A illustrates a third embodiment of a closure system for delivering a sealant to an arteriotomy site.
• FIG.14B illustrates an interior section view of the closure system ofFIG.14A.
• FIG.14C illustrates a close-up view of a distal end of the handle device ofFIG.14A, further depicting a tension indicator.
• FIGS.15A-15D illustrate interior section views of the first actuator of the closure system inFIG.14A.
• Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure.
DETAILED DESCRIPTION
• A closure system for delivering a sealant to an arteriotomy and a method of use for sealing same is provided herein. The closure system further includes a sheath adaptor for attachment to an existing procedural sheath and, thus, avoiding the need for a sheath exchange by removing the procedural sheath and inserting another sheath.FIGS.1A-1I illustrate a method of delivering asealant18 to anarteriotomy site2 using aclosure system20. In general, theclosure system20 can include ahandle portion30 having afirst actuator32, asecond actuator34, and athird actuator36 that can be used to control the features of theclosure system20. Anouter catheter22 can extend from thehandle portion30 and can move axially with thehandle portion30. Thehandle portion30 can include asheath catch40, or sheath adaptor, at a distal section of thehandle portion30.
• Aninner catheter24 can extend through theouter catheter22. Theinner catheter24 can include anexpandable structure26 positioned at a distal section of theinner catheter24. Theinner catheter24 can move axially relative to theouter catheter22, for example, by actuating thefirst actuator32 to release theinner catheter24 from theouter catheter22 and by retracting or advancing thethird actuator36 to move theinner catheter24. Although the examples provided herein will describe theexpandable structure26 as a balloon, the expandable structure could alternatively be a basket, expandable wire braid, expandable mesh, expandable frame, rotatable structure, and the like. In an alternative embodiment, the expandable structure may include a bioabsorbable foot plate or other element on one end, e.g., for providing tactile feedback to the user during a sealing procedure and/or sealing the puncture.
• Thesealant18 can be positioned in adistal section60 of theouter catheter22, radially between theinner catheter24 and theouter catheter22. For example, theinner catheter24 can extend through thesealant18, while theouter catheter22 surrounds thesealant18. Thesealant18 may include a first, proximal or main section formed from freeze-dried hydrogel, and a second, distal, or tip section (not shown) formed from a plurality of non-freeze-dried and/or non-cross-linked precursors, e.g., formed as a solid mass or solid plug, fused or otherwise attached to and extending distally from the first section, as disclosed in U.S. application Ser. No. 13/354,278, titled “Apparatus and Methods for Sealing a Vascular Puncture,” filed Jan. 19, 2012, and incorporated herein by reference in its entirety. Additional details regarding sealant composition can be found in U.S. Pat. No. 7,335,330, titled “Apparatus and methods for sealing a vascular puncture,” filed Nov. 5, 2004, and incorporated herein by reference in its entirety.
• Asupport tube28 or support member can be positioned proximal to thesealant18, radially between theinner catheter24 and theouter catheter22. For example, thesupport member28 can be tubular such that theinner catheter24 can extend through thesupport member28, while theouter catheter22 surrounds thesupport member28. Thus, thesupport member28 can include a lumen extending between a proximal end and distal end to accommodate slidably receiving theinner catheter24 therethrough. Thesupport member28 can support thesealant18 during the positioning of thesealant18 and tamp thesealant18 against the vessel wall V to close thearteriotomy2. Thesupport member28 may be substantially rigid, semi-rigid, and/or substantially flexible, e.g., having sufficient column strength to allow proximal movement of the closure system relative to thesealant18 without buckling thesupport member28 and/or to allow the distal end of thesupport member28 to be advanced to compress thesealant18 within a puncture. Thesupport member28 can move axially relative to theouter catheter22 and the expandable structure on theinner catheter24, for example, by actuating thesecond actuator34. In some configurations, actuating thesecond actuator34 can release theinner catheter24 from thesupport member28.
• In combination with or in place of any of the features described herein, theclosure system20 can include any of the features of the sealant delivery apparatuses described in U.S. Publication No. 2014/0025103, filed Sep. 25, 2013, which is hereby incorporated by reference in its entirety.
• FIG.1A illustrates aprocedural sheath10 extending through anarteriotomy2. Theprocedural sheath10 can be the same sheath used during the diagnostic and/or therapeutic procedure. As shown inFIG.1A, theprocedural sheath10 can include ahub portion14 having aside port16. Theside port16 can be secured to an irrigation and/oraspiration line12.
• After the diagnostic and/or therapeutic procedure, theclosure system20 can be introduced through theprocedural sheath10 by introducing theouter catheter22 through the hub portion14 (seeFIG.1B). Theouter catheter22 can be sized to be compatible with 5F or larger standard procedural sheaths.
• Theclosure system20 can be advanced through theprocedural sheath10 until thesheath adaptor40 engages thehub portion14 of the procedural sheath10 (seeFIG.1C). As described in further detail below, thesheath adaptor40 can be designed to removably engage theside port16 orirrigation line12 of thehub portion14.
• With theclosure system20 coupled to theprocedural sheath10, theexpandable structure26 of theinner catheter24 can be expanded using the syringe50 (seeFIG.1D). Theexpandable structure26 can be expanded until theinflation indicator54 indicates theexpandable structure26 has been expanded to a pre-determined pressure. For example, theinflation indicator54 can move from a first position to a second position when theexpandable structure26 is fully expanded. As shown inFIG.1D, theinflation indicator54 in the second position can protrude from a proximal end of thehandle portion30; however, theinflation indicator54 can be positioned elsewhere on thehandle portion30. Alternatively, any other appropriate inflation indicator can be employed. One alternative can include a pressure gauge with a dial that has a needle indicator that displays pressure readings and can show the complete inflation of the balloon. After theexpandable structure26 has been expanded, theinflation line56 can be sealed by closing thevalve52.
• With theexpandable structure26 expanded, theclosure system20 and theprocedural sheath10 can be retracted until theexpandable structure26 abuts an inner surface of the vessel wall V (seeFIG.1E).
• Theinner catheter24 can be released from theouter catheter22 by actuating or depressing thefirst actuator32. After theinner catheter24 has been released, theprocedural sheath10 and theouter catheter22 can be retracted relative to theinner catheter24 to expose the sealant18 (seeFIG.1F). In this configuration, thehandle portion30 can slide over thefirst actuator32 to retract theouter catheter22, while theinner catheter24 remains in place.
• With thesealant18 exposed, thesupport member28 can be advanced to tamp thesealant18 against an outer surface of the vessel wall V. As described above, actuation or depression of thesecond actuator34 can advance thesupport member28 relative to theinner catheter24 and theouter catheter22.
• After thesealant18 has been tamped, theexpandable structure26 can be contracted, for example, by opening thevalve52 and deflating theexpandable structure26 using the syringe50 (seeFIG.1H). With theexpandable structure26 contracted, theexpandable structure26 can be retracted through thesealant18 by actuating or depressing thethird actuator36. Theinner catheter24 can be retracted relative to theouter catheter22 and/or support member28 (seeFIG.1I). After theexpandable structure26 has been retracted through thesealant18, theentire closure system20 andprocedural sheath10 can be removed from the body, leaving thesealant18 in place against the vessel wall V. Since thesheath adapter40 is coupled to theprocedural sheath10, theclosure system20 and theprocedural sheath10 can be removed together, but theclosure system20 could be disengaged from theprocedural sheath10 and removed separately.
• FIG.2 illustrates an enlarged view of theclosure system20 prior to sealant delivery. As described above, thesealant18 can be positioned in adistal section60 of theouter catheter22, radially between theinner catheter24 and theouter catheter22. Thesupport member28 can be positioned proximal to thesealant18. At least thedistal section60 of theouter catheter22 can include anouter sleeve62 and aninner sleeve64. Each of theouter sleeve62 and theinner sleeve64 can include at least one slit62a,64a, respectively (e.g., one slit, two slits, three slits, or more). Theouter sleeve62 and theinner sleeve64 can include the same number of slits or different numbers of slits. Theslits62a,64acan be positioned so that the slits are not aligned with each other. In one aspect, the outer slit62acan be positioned opposite theinner slit64a(e.g., about 180 degrees apart). The inner andouter sleeves62,64 can be overlapping such that thesealant18 is circumferentially surrounded by the combination of the inner andouter sleeves62,64 to minimize exposure to bodily fluids entering theouter catheter22 through theslits62a,64a.
• In one aspect, theouter sleeve62 can be longer than theinner sleeve64. Theouter sleeve62 can extend back to thehandle portion30, for example such that it is integral with the outer catheter, while theinner sleeve64 can be secured to theouter sleeve62 proximal to theslits62a,64a. Theinner sleeve64 and theouter sleeve62 can be attached using a thermal attachment, adhesive bond, mechanical bond, or other appropriate attachment method. With theinner sleeve64 disposed within theouter sleeve62, an inner diameter of thedistal section60 can be less than an inner diameter of a proximal section of theouter catheter22.
• In one instance, theinner sleeve64 can be stiffer than theouter sleeve62 to provide support for theouter sleeve62. For example, theinner sleeve64 and theouter sleeve62 can have varying thicknesses and/or be constructed from different materials. In one embodiment, theinner sleeve64 can be constructed from polyimide or a similarly rigid polymer, while theouter sleeve62 can be constructed from a softer material, such as polyamide. In another embodiment, theouter sleeve62 can be constructed from a polyether block amide, such as Pebax®, or from a nylon material. However, any other appropriate materials may be used for the inner and outer sleeves. Although not shown, in another aspect, theouter sleeve62 can be thermally shaped with a smaller radius at the distal end to provide an atraumatic tip during delivery.
• Thedual layer sleeve62,64 can help maintain the sealant in theclosure system20 when theclosure system20 is being retracted through the arteriotomy. The slit design of thedistal section60 reduces friction during deployment of the sealant and reduces the risk of jamming the sealant. For example, if thesealant18 begins to expand while still positioned in the closure system20 (e.g., from bodily fluids entering from a distal end), the slit design of thedistal section60 provides space for thesealant18 to expand without jamming theclosure system20.
• FIGS.9A-9G illustrate a second embodiment of aclosure system120. In this embodiment, theclosure system120 can comprise one or more actuators that assist in deploying the sealant, tamping the sealant and retracting the expandable structure and, in particular, three actuators. Similar features to the first embodiment illustrated and discussed inFIGS.1A-1I have similar numbers.
• Similar to the function of theclosure system20 inFIG.1B, theclosure system120 can be introduced through theprocedural sheath10 by introducing theouter catheter22 through the hub portion14 (seeFIG.9A). Theouter catheter22 can be sized to be compatible with 5F or larger standard procedural sheaths.
• Theclosure system120 can be advanced through theprocedural sheath10 until thesheath adaptor40 engages thehub portion14 of theprocedural sheath10. As described in further detail below, thesheath adaptor40 can be designed to removably engage theside port16 orirrigation line12 of thehub portion14.
• Similar to the first embodiment presented above, theinner catheter24 can extend through theouter catheter22. Theinner catheter24 can include anexpandable structure26, such as a balloon or other appropriate element as discussed above, positioned at a distal section of theinner catheter24. Theinner catheter24 can move axially relative to theouter catheter22, for example, by actuating or depressing thefirst actuator32 to release theinner catheter24 from theouter catheter22 and by actuating or depressing thethird actuator36 to move theinner catheter24 into thesupport member28. In order to provide compatibility with the existing procedural sheath, the sheath of the closure system is integrated with the device handle. This can be accomplished by providing theinner sleeve64 and theouter sleeve62 which form the inner/outer sleeve assembly, e.g., the two sleeves at the distal end. This integrated sheath, e.g.,outer catheter22, can be fixed to the handle and retracts during sealant deployment. Theouter catheter22 can move radially within the handle to minimize the impact of torsional forces on theouter catheter22 and on theouter sleeve62; this can allow theouter sleeve62/catheter22 to rotate freely within the handle.
• With theclosure system120 coupled to theprocedural sheath10, theexpandable structure26 of theinner catheter24 can be expanded using the syringe50 (seeFIG.9B). Theexpandable structure26 can be expanded until theinflation indicator154 indicates theexpandable structure26 has been expanded to a pre-determined pressure. For example, theinflation indicator154 can move from a first position to a second position when theexpandable structure26 is fully expanded. As shown inFIG.9B, theinflation indicator154 in the second position can protrude from a proximal end of thehandle portion130; however, theinflation indicator154 can be positioned elsewhere on thehandle portion130. After theexpandable structure26 has been expanded, theinflation line56 can be sealed by closing thevalve52. With theexpandable structure26 expanded, theclosure system120 and theprocedural sheath10 can be retracted until theexpandable structure26 abuts an inner surface of the vessel wall V.
• Theinner catheter24 can be released from theouter catheter22 by actuating or depressing thefirst actuator132. As theinner catheter24 is released, theprocedural sheath10 and theouter catheter22 can also be retracted relative to theinner catheter24 to expose thesealant18 by simultaneously retracting the handle and the procedural sheath (seeFIG.9C). In this configuration, thehandle portion130 slides over thefirst actuator132 to retract theouter catheter22, while theinner catheter24 remains in place. As thefirst actuator132 is depressed and thehandle body130 is slid back, avisual indication180 becomes visible through awindow182 that is exposed upon sliding thehandle130 proximally covering thefirst actuator132 to display an image indicating whether the sealant has been properly deployed.
• With thesealant18 exposed, thesupport member28 can be advanced to tamp thesealant18 against an outer surface of the vessel wall V. Actuation or depression of thesecond actuator134 can advance thesupport member28 relative to theinner catheter24 and theouter catheter22. Additionally, thevisual indicator180 visible through thewindow182 can display a different image that indicates the tamping of the sealant has been completed successfully and initiation of dwell period of sealant activation.
• After thesecond actuator134 has been depressed, but before thethird actuator136 has been depressed, theinflation indicator154 can provide a lockout feature that prevents thethird actuator136 from being depressed while theexpandable structure26 is in an expanded configuration (seeFIG.9E). Theinflation indicator154 can extend through a proximal portion of thehandle130 such that a distal portion of theinflation indicator154 is positioned below thethird actuator136. When theinflation indicator154 is in the second position (e.g., extending beyond the proximal end of the handle130) this not only indicates that theexpandable structure26 is inflated but further provides ablocking segment140 integral with theinflation indicator154 but internal to the handle body.
• After thesealant18 has been tamped, theexpandable structure26 can be contracted, for example, by opening thevalve52 and deflating theexpandable structure26 using the syringe50 (seeFIG.9F). With theexpandable structure26 contracted, theexpandable structure26 can be retracted through thesealant18 by actuating thethird actuator136. Theinner catheter24 can be retracted relative to theouter catheter22 and/or support member28 (seeFIG.9G). After theexpandable structure26 has been retracted through thesealant18, theentire closure system20 andprocedural sheath10 can be removed from the body, leaving thesealant18 in place against the vessel wall V. Since thesheath adapter40 is coupled to theprocedural sheath10, theclosure system20 and theprocedural sheath10 can be removed together, but theclosure system20 could be disengaged from theprocedural sheath10 and removed separately.
• Turning now toFIGS.10A-13B, thehandle portion130 of theclosure system120 is illustrated in further detail. The interior of thehandle130 contains a proximal142 and distal144 sled assembly that slides or glides within the interior of the handle as it is actuated, as shown inFIGS.10A-10B. Thedistal sled assembly144 can integrate thefirst actuator132, such that when the first actuator is depressed and the handle is retracted, the distal sled assembly moves distally with respect to the handle, as shown inFIG.10B. The proximal142 and distal144 sled assemblies are in a locked position with respect to thehandle130 until thefirst actuator132 is fully depressed and locked into a second, depressed position. Upon depression of thefirst actuator132, bothdistal sled assembly144 and theproximal sled assembly142 are unlocked and can move distally with respect to thehandle body130 when the handle is retracted. Theproximal sled assembly142 can house theinner catheter24 and the inflation indicator.
• Turning toFIG.10C, a close-up view of thedevice120 is shown attached and locked with the procedural sheath atcatch40. The sheath catch oradaptor40 can be oriented in any position or direction and, alternatively, can be provided such that it may be able to rotate about thehandle130 such that it can be adjusted to more easily catch the port or irrigation line of the procedural sheath.
• In addition to actuating the distal sled assembly, thefirst actuator132 can also display avisual indication180 through awindow182 that can provide a storyboard for the user to understand that the outer sleeve has been successfully retracted and the sealant deployed, as shown inFIGS.11A-C.FIG.11A shows a portion of thehandle body130 containing the first actuator, where thefirst actuator130 can also optionally have a visual indication to identify that it is the first actuator in a series of actuators. Upon actuating or depressing thefirst actuator132, a first image or visual indication can become visible and, for example, can display a symbol such as a check mark or other appropriate symbol through thewindow182 to indicate that the sealant has been deployed, as shown inFIG.11B. Once thesecond actuator134 is also depressed, the storyboard can further display another image to convey that the sealant has been successfully tamped, as shown inFIG.11C. Although a check mark and a circle with a symbol in it are shown, any visual indication or image may be used as appropriate to indicate the step completed.
• Thesecond actuator134 can include a cam drive mechanism, as shown inFIGS.12A-12B, that can drive thedistal sled assembly144 associated with thefirst actuator132 andsupport member28 in a distal direction to tamp the sealant. Thesecond actuator134 can interface with aramp146 on the proximal end of thedistal sled assembly144/first actuator132, which can be overmolded onto thesupport member28 such that any distal movement of thedistal sled assembly144 can also move thesupport member28 in a distal direction. When thesecond actuator134 is depressed, thedistal face148 of thesecond actuator134 can contact theramp146 of thedistal sled assembly144 pushing it in a distal direction and can advance thedistal sled assembly144 and thesupport member28 in a distal direction causing the sealant to be compressed and tamped by advancement of thesupport member28.
• Thethird actuator136 can be depressed to retract the deflatedexpandable structure26 back into thesupport member28, as seen inFIGS.13A and13B. In one aspect, the retraction of theexpandable structure26 can be accomplished by anarm150, as seen in a further close-up interior view inFIGS.13C and13D, that extends from thethird actuator136 and below a top/outer surface of thethird actuator136. As thethird actuator136 is depressed, it can cause thearm150 to engage with theinner catheter24 and upon engaging the catheter, the arm can kink theinner catheter24 on the proximal end, such that it can bend thecatheter24 away from a central axis of thehandle130, as seen inFIG.13D, causing it to retract in the proximal direction, thereby causing theexpandable structure26 to retract into thesupport member28.
• In addition, if theexpandable structure26 is in an inflated state, as indicated by theinflation indicator154 being extended beyond the proximal end of thehandle130, then thethird actuator136 cannot be depressed due to a lock-out feature. The lock-out feature is provided by a portion of theinflation indicator154 that extends internally and distally into thehandle130 and further havingprotrusions140 that extend axially outward away from the central axis of thehandle130 which act as a lock or stop that prevents thethird actuator136 from being depressed. When theexpandable structure26 is deflated, then theinflation indicator154 can be shifted in a distal direction, such that it is no longer visible proximal to the handle. This motion of theinflation indicator154 can also shift the position of theprotrusions140 that lock thethird actuator136 in place. Once shifted, thethird actuator136 is free to be depressed. This lockout feature provided by theinflation indicator154 is beneficial in preventing an accidental depression of thethird actuator136 such that the expandable structure is not retracted prior to being fully deflated. In an alternative aspect, the lockout element can be a protrusion that extends axially toward the center of thehandle130 and locks out the distal arm on thethird actuator136 such that thethird actuator136 cannot be depressed.
• An alternate embodiment of aclosure system220 is illustrated inFIGS.14A-15D. In this embodiment, theclosure system220 can comprise 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.
• Similar to the function of theclosure system20 inFIG.1B, theclosure system220 can be introduced through a procedural sheath (not shown) by introducing theouter catheter22 through the hub portion14 (not shown). Theouter catheter22 can be sized to be compatible with 5F or larger standard procedural sheaths.
• As seen inFIG.14A thehandle230 can contain at least one actuator and, in particular, two actuators. Although not shown, theclosure system220 can also be advanced through the procedural sheath until thesheath adaptor40 engages the hub portion of the procedural sheath, just as in the previous embodiments. Theclosure system220 can perform in a similar manner as the previous embodiments in regard to advancement through the procedural sheath and locking the handle via thesheath adaptor40 to the procedural sheath.
• Turning toFIG.14A, thehandle230 is shown having afirst actuator222 and asecond actuator224. Thefirst actuator222 can have a combined function that both retracts theouter catheter22 and tamps thesealant18 when actuated. Thesecond actuator224 can have a function that is similar to thethird actuators36 and136 from the previous embodiments. When thesecond actuator224 is depressed, it can retract theexpandable structure26 into the support member ortube28. AlthoughFIGS.14A-15D only show the closure device, the device can be employed in a similar manner as depicted inFIGS.1B-1I and9A-9G to effect a closure process in an arteriotomy.
• Additionally, atension indicator206 can be incorporated into thehandle230 design, as shown inFIG.14C, by including atension indicator window228 through which an illustration or image can be visible that indicates whether proper tension has been applied on theexpandable structure26 upon placement of theexpandable structure26 at the inner surface of the vessel wall, V. Thetension indicator206 can provide a visual cue to the user when the proper amount of tension has been applied to theexpandable structure26 prior to deploying thesealant18. It is beneficial to know when the tension is appropriate because if excessive tension is exerted by theexpandable structure26 on the arterial wall it can cause the vessel to tent (e.g., distend) such that the artery is moved out of its initial position, e.g., its original anatomical position, during the closure process. If thesealant18 is deployed with the artery in this tented position, then the tissue compression around the tented vessel may elicit a subtle separation of thehydrogel sealant18 from the surface of the puncture site as the artery returns to its normal position after theexpandable structure26 is deflated and thedevice220 is removed from the patient.
• Turning toFIG.14B, an internal view of thehandle230 is illustrated. Thehandle230 can have aproximal sled assembly242 that can house theinner catheter24, similar to the other embodiments. When theexpandable structure26 is inflated in the patient's artery and pulled back to the arteriotomy, theexpandable structure26 can meet resistance when it is up against the vessel wall and the force exerted on theexpandable structure26 can be transferred back to theproximal sled assembly242. Theproximal sled assembly242 can move in a distal direction when theexpandable structure26 is under tension, thereby compressing atension spring202 housed in thetension indicator206. Thetension indicator206 can begin to move in a distal direction when the force on theexpandable structure26 exceeds the pre-load on thetension spring202. Thefirst actuator222 can be depressed when a protrusion or black line on thetension indicator206 lies within or is aligned with theproper tension zone226 on thedevice handle230, illustrating that thetension indicator206 is in the appropriate position within thetension indicator window228, as illustrated inFIG.14C.
• If thetension indicator206 does not line up with theproper tension zone226, then thefirst actuator222 cannot be actuated or depressed, since the tension applied on theexpandable structure26 is not in the proper tension zone (e.g., black band). Thus, thetension indicator zone226 can include lockout features that can prevent thefirst actuator222 from being depressed when improper tension is applied via theexpandable structure26. Thetension zone226 can be indicated in any manner and, in the embodiment shown inFIG.14C, it is indicated by a black line marked on thehandle device230. The position of the black line on thehandle230 is positioned in the proper tension zone. Thetension indicator206 can be a sliding piece inside of thehandle assembly230 that can slide distally based upon the tension applied on theexpandable structure26. Therefore, to ensure correct tension is being applied to theexpandable structure26, the user can adjust the tension upon theexpandable structure26 until the black line on thetension indicator206 is aligned with the black line on the handle of thetension zone226. The tension can be adjusted, in one aspect, by pulling back or letting up on the handle of the closure device, whichever is necessary. Alternatively, any other visual indication system may be used as appropriate to indicate proper tension applied to theexpandable structure26.
• Turning toFIGS.15A-D, an internal view of the handle housing is shown, these views do not show thetension indicator206, however, it can be included if desired as shown inFIGS.14A-C.FIG.15A illustrates thehandle230 at rest, before thefirst actuator222 has been depressed. It can be seen that in the rest position, aninner rib212 on thefirst actuator222 can engage with or contact aramp214 on thepull rack208. Thepull rack208 can be connected to the outer sleeve assembly62 (not shown). As thefirst actuator222 is actuated or depressed thepull rack208 can begin to shift in a proximal direction, e.g., away from thesheath adaptor40. As thepull rack208 shifts in a proximal direction by actuation of thefirst actuator222, theouter sleeve62 also begins to shift in a proximal direction, thus, exposing the sealant in the tissue tract next to the arteriotomy. As thefirst actuator222 is being initially depressed, as inFIG.15B, the sealant can begin to be exposed by retraction of the sleeve.
• As thefirst actuator222 is depressed partially, as inFIG.15B, thedistal face218 of thefirst actuator222 can engage with thepush rack210 and can begin to shift thepush rack210 in a distal direction, e.g., toward thesheath adaptor40, at a point that the sealant is at least partially exposed and, in one aspect, is exposed about 50%. Thepush rack210 can be connected to thesupport member28, or tamp tube, such that when thepush rack210 is shifted in a distal direction it is also shifting thesupport member28 in a 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 pull rack208 (e.g., as the first actuator is being initially depressed), both thepush rack210 and pullrack208 can move in their respective directions simultaneously or relatively simultaneously revealing the sealant and tamping the sealant. It is preferable that at least a portion of the sealant be exposed prior to tamping; this can help to mitigate jamming of the sleeve and/or sealant. In this embodiment, about 50% of the sealant is exposed before thepush rack210 is engaged, however, any other appropriate amount of the sealant can be exposed that is less than or greater than 50% before engaging thepush rack210.
• InFIG.15C, thepull rack214 is shown in its final position, shifted proximal to where it began, while thepush rack216 is shown in its final position, shifted distal to where it began.FIG.15D shows thefirst actuator222 fully depressed with theramp216 on thepush rack210 exposed internal to thehandle230. Thefirst actuator222, or combination actuator, can drive thepull rack208 and thepush rack210 utilizing a cam drive mechanism similar to the previous embodiment. Thefirst actuator222 can include features that engage with each rack and can drive them in the desired direction.
• Although not illustrated, depressing thesecond actuator224 can retract theexpandable structure26 similar to how the third actuator functions in the previous embodiments and can also further include a lockout mechanism that can prevent thesecond actuator224 from being depressed if theexpandable structure26 is still inflated, as indicated by theinflation indicator254. This lockout feature is similar to that described above in regard to the second embodiment having a blocking segment orprotrusions140 extending from the proximal sled assembly and as shown inFIGS.10A,10B,13A and13B.
• This embodiment illustrates ahandle device230 having two actuators, however, the handle can have more or less actuators than that described herein. For instance, the handle can be provided with only one actuator that carries out all of the functions described herein or one actuator that carries out one or more functions while another method is employed for any remaining functions. Thus, the handle on the closure device can have one or more actuators, as appropriate.
• FIG.3 illustrates an enlarged view of thesheath adapter40 that can engage any sheath having a side port or irrigation line. Thesheath adapter40 can be integral with thehandle portion30 or a separate component coupled to thehandle portion30, either directly or via an intervening catheter shaft or other linking structure.
• As shown inFIG.3, thesheath adapter40 can have any shape that is appropriate and, in particular, can have a generally tubular, cylindrical or generally frustoconical shape. Thesheath adaptor40 can include polycarbonate, ABS, silicone, an elastomer, or other suitable materials. An elastomeric material may be beneficial to enable thesheath adapter40 to grip theside port16 orirrigation line12 of thesheath10.
• Thesheath adapter40 can include an attachment structure that can releasably attach to a procedural sheath, such as a bayonet connector orhook portion42 that can hook around a transverse retention surface such as a distally facing surface on theside port16 orirrigation line12 of aprocedural sheath10. Thehook portion42 can form a passageway44 that can guide theside port16 orirrigation line12 into engagement with thesheath adapter40. Thehook portion42 can be shaped such that both axial and rotational movement is required to disengage thehook portion42 from thesheath10.
• The passageway44 can be defined by a distal facingedge48a, an outerlateral edge48b, a proximal facingedge48c, an inner lateral edge48d, and a hook end edge48e. The edges defining the passageway44 can be generally straight or curved. The distance D₁between the distal facingedge48aand the hook end edge48ecan be sized to permit theside port16 orirrigation line12 to enter the passageway44. For example, the distance D₁can be within about 10% or within about 20% of a diameter of theside port12 or theirrigation line12, 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 D₁can be less than the distance D₂between the distal facingedge48aand the proximal facingedge48c(less than about 60 percent of D₂, less than about 50 percent of D₂, less than about 40 percent of D₂, less than about 30 percent of D₂, less than about 20 percent of D₂, or otherwise).
• The distance D₃between the outerlateral edge48band the inner lateral edge48dcan be sized to receive theside port16 orirrigation line12 of theprocedural sheath10. For example, the distance D₃can be within 10% of a diameter of theside port16 orirrigation line12, 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 D₃can be less than the distance D₁.
• The inner lateral edge48dcan have a length suitable to block theside port16 orirrigation line12 from disengaging from thesheath adapter40 when theclosure system20 is rotated. For example, the length of the inner lateral edge48dcan be at least as long as a diameter of theside port16 or theirrigation line12. The length of the inner lateral edge48dcan be at least about 20% of a length L of thesheath adapter40, at least about 30% of a length L of thesheath adapter40, or at least about 40% of a length L of thesheath adapter40. The length of the inner lateral edge48dcan be at least as long as the distance D₃.
• Although not shown, in some embodiments, the distance D₃can narrow from the proximal facingedge48ctoward the hook end edge48e. Thehook portion46 can be spring-like and move away from the outerlateral edge48bto enlarge the distance D₃between the outerlateral edge48band inner lateral edge48dto permit theside port16 orirrigation line12 to move toward the proximal facingedge48c. Thehook portion46 can rebound back toward the outerlateral edge48bto retain theside port16 orirrigation line12.
• FIG.4 illustrates an enlarged view of anothersheath adapter70 that can be used with theclosure system20 to engage any sheath having a side port or irrigation line. Thesheath adapter70 can be integral with thehandle portion30 or a separate component coupled to thehandle portion30.
• As shown inFIG.4, thesheath adapter70 can have a generally cylindrical or generally frustoconical shape. Thesheath adaptor70 can include polycarbonate, ABS, silicone, an elastomer, or other suitable materials. An elastomeric material may be beneficial to enable thesheath adapter40 to grip theside port16 orirrigation line12 of thesheath10.
• Thesheath adapter70 can include an attachment structure (e.g., a bayonet connector) that can releasably attach to a procedural sheath. For example, the attachment structure can include afirst hook portion72 having a firsthook end portion72aand asecond hook portion74 having a secondhook end portion74a. At least a portion of the first andsecond hook portions72,74 can extend distally beyond a distal facingedge76 of a remaining portion of thesheath adapter70.
• Thefirst hook portion72 and thesecond hook portion74 can be generally the same shape and size but inverted relative to each other, such thatlower surfaces72b,74bof the first andsecond hook portions72,74 are tapered inward and toward each other to guide theside port16 orirrigation line12 toward apassageway78. Thesheath adapter70 can be generally symmetrical across a plane extending between the first andsecond hook portions72,74 and through the longitudinal axis of thesheath adapter70.
• A distance B₁between a firsthook end portion72aand a secondhook end portion74acan be less than a diameter of theside port16 orirrigation line12 to prevent theside port16 orirrigation line12 from inadvertently detaching from thesheath adaptor70. The hook ends72a,74acan bend to enlarge the distance B₁to allow theside port16 orirrigation line12 to enter thepassageway78, but then rebound once theside port16 orirrigation line12 is in thepassageway78 such that theside port16 orirrigation line12 is retained between the hook ends72a,74aand the distal facingedge78d. The spring-like hook ends72aand74acan be designed to retain theside port16 orirrigation line12 under normal use but can be overcome by the user if detachment of thesheath adapter70 is necessary.
• Eachhook portion72,74 can define a portion of thepassageway78. Eachhook portion72,74 can have an innerlateral edge78a, a proximal facingedge78b, an outerlateral edge78c, and a distal facingedge78d. The edges defining thepassageway78 can be generally straight or curved.
• The distance B₂between the inner and outerlateral edges78a,78ccan be sized to permit the necessary bending of thehook portions72,74 toward their respective outerlateral edge78cto allow theside port16 orirrigation line12 to enter thepassageway78.
• FIG.5 illustrates an enlarged view of anothersheath adapter80 that can be used with theclosure system20 to engage any sheath having a side port or irrigation line. Thesheath adapter80 can be integral with thehandle portion30 or a separate component coupled to thehandle portion30. As shown inFIG.5, thesheath adapter80 can include aproximal flange82 to engage thehandle portion30.
• As shown inFIG.5, thesheath adapter80 can have a generally cylindrical or generally frustoconical shape. Thesheath adaptor80 can include polycarbonate, ABS, silicone, an elastomer, or other suitable materials. An elastomeric material may be beneficial to enable thesheath adapter40 to grip theside port16 orirrigation line12 of thesheath10.
• Thesheath adapter80 can include an attachment structure that can releasably attach to a procedural sheath, such as bayonet connector orhook portion84. A distal facingedge88 of thesheath adapter80 can extend distally beyond thehook portion84.
• Thehook portion84 can form apassageway86. Thepassageway86 can be defined by ahook end edge86a, a proximal facing edge84b, a first innerlateral edge86c, a first distal facingedge86d, a second innerlateral edge86e, a second distal facingedge86f, and an outer lateral edge86g. The edges defining thepassageway86 can be generally straight or curved.
• Thehook end edge86acan be tapered inward toward thepassageway86 to guide theside port16 orirrigation line12 toward thepassageway86. A distance C₁between thehook end edge86aand the outer lateral edge86gcan be sized to prevent theside port16 orirrigation line12 from inadvertently exiting thepassageway86. Thehook portion84 can be a spring-member that can be deflected away from the central axis of thesheath adapter80 to enlarge C₁to permit passage of theside port16 orirrigation line12 into thepassageway106. After theside port16 orirrigation line12 is positioned in thepassage86, thehook portion84 can return to its original state such that theside port16 orirrigation line12 is retained between the proximal facingedge86band the second distal facingedge86f.
• The second distal facingedge86ecan be proximal to the first distal facingedge86cand spaced apart from the first distal facingedge86cby the second innerlateral edge86e. The second distal facingedge86ecan be generally curved to guide theside port16 orirrigation line12 toward the innerlateral surface86c. The distance C₂between the second innerlateral edge86eand the outer lateral edge86gcan be greater than the distance C₁and sized to receive theside port16 orirrigation line12. In one aspect, C₁can be about 0.126 inches and C₂can be about 0.210 inches, however, other appropriate dimensions are possible.
• A length of the proximal facingedge86band/or the first distal facingedge86dcan be sufficient to enable thehook portion84 to deflect outward and enlarge the distance C₁to permit passage of theside port16 or theirrigation line12. For example, the proximal facingedge86band/or the first distal facingedge86dcan extend around at least 20% of a circumference of thesheath adapter80, at least about 30% of a circumference of the sheath adapter, at least about 40% of a circumference of the sheath adapter, or at least about 50% of a circumference of thesheath adapter80. A length of the proximal facingedge86bcan be longer than a length of the first distal facingedge86d.
• Alternatively, a distance C₃, between the proximal facingedge86band the first distal facingedge86d, can be sized to permit theside port16 orirrigation line12 to traverse thepassageway86. The distance C₃can be within 10% or within about 20% of a diameter of theside port16 orirrigation line12. The distance C₃can be less than the distance C₁.
• FIG.6 illustrates an enlarged view of anothersheath adapter90 that can be used with theclosure system20 to engage any sheath having a side port or irrigation line. Thesheath adapter90 resembles thesheath adapter80 discussed above in many respects. Accordingly, numerals used to identify features of thesheath adapter80 are incremented by a factor of one ten (10) to identify like features of thesheath adapter90.
• Unlike thesheath adapter80, the hook end edge96aof thesheath adapter90 is generally straight and a distal section of the outerlateral edge96hcan be tapered inward to guide theside port16 orirrigation line12 into thepassageway96. The distal section of the outerlateral edge96hand the proximal section of the outer lateral edge96gare separated by a proximal facing step96i.
• Thesheath adapter90 can include a protruding portion orthumb grip91 extending radially outward from thesheath adapter90, which allows for the user to bend the hook end96aoutward away from the central axis ofsheath adaptor90 in order to enlarge C₁and enable the removal of thesheath10 from thesheath adaptor90.
• FIG.7 illustrates an enlarged view of anothersheath adapter100 that can be used with theclosure system20 to engage any sheath having a side port or irrigation line. Thesheath adapter100 can be integral with thehandle portion30 or a separate component coupled to thehandle portion30. As shown inFIG.7, thesheath adapter100 can include aproximal flange102 to engage thehandle portion30. Theproximal flange102 may have a detent feature that permits the user to rotate thesheath adapter100 for optimal positioning to accommodate side ports positioned at various angles, but prevent rotation of thesheath adaptor100 during the procedure.
• As shown inFIG.7, thesheath adapter100 can include an attachment structure that can releasably attach to a procedural sheath, such as a bayonet connector orhook portion104. Thehook portion104 can protrude radially outward from thesheath adapter100. Thehook portion104 can be shaped such that axial and rotational movement are required to disengage thesheath adapter100 from thesheath10. Alternatively thehook portion104 may be configured such that it must be depressed to disengage thesheath adapter100 from thesheath10.
• Thehook portion104 can form apassageway106. Thepassageway106 can be defined by a lower hook edge106a, ahook end edge106b, anupper hook edge106c, an innerlateral edge106d, a distal facingedge106e, and an outerlateral edge106f. The edges defining thepassageway106 can be generally straight or curved. The lower hook edge106acan be generally tapered inward to guide theside port16 orirrigation line12 toward thepassageway106.
• A distance E₁between thehook end edge106band the outerlateral edge106fcan be sized to prevent theside port16 orirrigation line12 from inadvertently escaping thepassageway106. Thehook portion104 can be a spring-member that can be deflected toward the innerlateral edge106dto decrease the distance E₃and increase the distance E₁to permit passage of theside port16 orirrigation line12 into thepassageway106. After theside port16 or theirrigation line12 is positioned in thepassageway106, thehook portion104 can return to its original state such that theside port16 orirrigation line12 is retained between the distal facingedge106eand thehook end edge106b.
• A length of theupper hook edge106ccan be sufficient to enable thehook portion84 to deflect toward the innerlateral edge106dand permit passage of theside port16 orirrigation line12 into thepassageway106. The length of theupper hook edge106ccan be sufficiently long to enable thehook end edge106 to facilitate the retention of theside port16 orirrigation line12 and inhibit thesheath10 from easily disengaging from thesheath adapter100 when the closure system is rotated or pulled. For example, a length of theupper hook edge106ccan be at least about 20% of a length L of thesheath adapter100, at least about 30% of a length L of thesheath adapter100, or at least about 40% of a length L of thesheath adapter100.
• The distal facingedge106ecan be generally curved to guide theside port16 orirrigation line12 toward the portion of thepassageway106 between theupper hook edge106cand the innerlateral edge106d. The distance E₂between the innerlateral edge106dand the outerlateral edge106fcan be greater than the distance E₁. In one aspect, E₁can be about 0.115 inches and E₂can be about 0.210 inches, however, other appropriate dimensions can be possible.
• FIG.8 illustrates another sheath adapter110 that can engage any sheath having aside port16 orirrigation line12. The sheath adapter110 can be integral with thehandle portion30 or include aproximal flange112 to engage thehandle portion30.
• As shown inFIG.8, the sheath adapter110 that can have a generally cylindrical or generally frustoconical shape. The sheath adaptor110 can include polycarbonate, ABS, silicone, and elastomer or other suitable materials. An elastomeric material may be beneficial to enable the sheath adapter110 to grip theside port16 orirrigation line12 of thesheath10.
• The sheath adapter110 can include an attachment structure that can releasably attach to a procedural sheath, such as a bayonet connector orhook portion114 that can hook around theside port16 orirrigation line12 of aprocedural sheath10. Thehook portion116 can extend distally beyond adistal edge118 of a remaining portion of the sheath adapter110. Thehook portion114 can form apassageway116 to retain theside port16 orirrigation line12. Thehook portion114 can be shaped such that both axial and rotational movement is required to disengage thehook portion114 from thesheath10.
• Thepassageway116 can be defined by an outer lateral edge116a, a proximal facingedge116b, an innerlateral edge116c. The edges defining thepassageway116 can be generally straight or curved. The distance F₁between the outer lateral edge116aand the an innerlateral edge116ccan be sized to permit theside port16 orirrigation line12 to enter thepassageway116. For example, the distance F₁can be within about 10% or within about 20% of a diameter of theside port12 or theirrigation line12. In one aspect, F₁can be about 0.200 inches, however, other appropriate dimensions are possible.
• In some embodiments, the distance F₁can narrow from the proximal facingedge116btoward thehook end edge116d. Thehook portion114 can be spring-like and move away from the innerlateral edge116cto enlarge the distance D₁between the outer lateral edge116aand innerlateral edge116cto permit theside port16 orirrigation line12 to move toward the proximal facingedge116b. Thehook portion114 can rebound back toward the innerlateral edge116cto retain theside port16 orirrigation line12.
• Although not shown, any of the sheath adapter embodiments can include barbs, threads, flanges, or other features to facilitate engagement with thesheath10, for example, a snap fit or a friction fit. These features can be used to engage the side port, irrigation line, or outer or inner surface of the procedural sheath hub. The addition of any of these features can also be used to permanently couple any of the sheath adapters described above and thesheath10.
Terminology
• As used herein, the relative terms “proximal” and “distal” shall be defined from the perspective 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 distal tip of the closure system.
• Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.
• The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.
• The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that 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 stated amount, as the context may indicate.
• The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers. For example, “about 10 percent” includes “10 percent.”
• Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “tamping the sealant” include “instructing tamping of the sealant.”
• Although certain embodiments and examples have been described herein, it will be understood by those skilled in the art that many aspects of the closure system shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable.
• Some embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.
• For purposes of this disclosure, certain aspects, advantages, and novel features are 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, those skilled in the art will recognize that the disclosure may be embodied or carried out 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.
• Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and/or inserting additional actions and/or deleting actions. It is intended, therefore, that the specification and examples be considered as illustrative only, with a true scope and spirit being indicated by the claims and their full scope of equivalents.

Claims (21)

1-26. (canceled)

27. A closure system for closing an arteriotomy, the closure system comprising:

a handle portion;

a sheath adapter comprising an attachment structure for releasable attachment to a procedural sheath;

an outer catheter extending distally from the handle portion, the outer catheter comprising a proximal section and a distal section;

an inner catheter extending through the outer catheter, the outer catheter axially movable with respect to the inner catheter;

a sealant positioned in the distal section of the outer catheter; and

a support tube proximal to the sealant and radially between the outer catheter and the inner catheter.

28. The closure system ofclaim 27, wherein the sheath adapter comprises a proximal flange configured to engage the handle portion.

29. The closure system ofclaim 27, wherein the sheath adapter and the handle portion are integral.

30. The closure system ofclaim 27, wherein the distal section of the outer catheter comprises an inner sleeve and an outer sleeve surrounding the inner sleeve.

31. The closure system ofclaim 30, wherein the proximal section of the outer catheter comprises a single layer.

32. The closure system ofclaim 30, wherein the inner sleeve comprises a first slit and the outer sleeve comprises a second slit.

33. The closure system ofclaim 32, wherein the first slit is circumferentially displaced from the second slit.

34. The closure system ofclaim 32, wherein the first slit is circumferentially displaced from the second slit by about 180 degrees.

35. The closure system ofclaim 27, wherein the inner catheter comprises an expandable structure positioned at a distal section of the inner catheter.

36. The closure system ofclaim 27, wherein the handle portion has an expandable structure at a distal end thereof.

37. The closure system ofclaim 36, wherein the handle portion has a tension indicator configured to indicate information associated with an amount of tension being applied to the vessel wall by the expandable structure.

38. The closure system ofclaim 37, wherein the handle portion comprises an actuator configured to both deploy the sealant within the arteriotomy and to tamp the sealant against a vessel wall of the arteriotomy.

39. The closure system ofclaim 38, wherein the handle portion further comprises a lockout mechanism configured to prevent the actuator from being actuated when the expandable structure is in an expanded state.

40. The closure system ofclaim 39, wherein the handle portion further comprises an inflation indicator at a proximal end thereof, wherein the inflation indicator is configured to move from a first position to a second position when the expandable structure is fully expanded.

41. A closure system for closing an arteriotomy, the closure system comprising:

a handle portion;

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 circumferentially displaced from the first slit;

an inner catheter extending through the outer catheter, the outer catheter removably secured to the inner catheter;

a sealant positioned in the distal section of the outer catheter; and

a support tube proximal to the sealant and radially between the outer catheter and the inner catheter.

42. The closure system ofclaim 41, wherein the proximal section of the outer catheter comprises a single layer.

43. The closure system ofclaim 41, wherein the first slit is circumferentially displaced from the second slit by about 180 degrees.

44. The closure system ofclaim 41, wherein the first slit and the second slit are distal to the support tube prior to deployment.

45. The closure system ofclaim 41, wherein the handle portion has an expandable structure at a distal end thereof.

46. The closure system ofclaim 45, wherein the handle portion has a tension indicator configured to indicate information associated with an amount of tension being applied to the vessel wall by the expandable structure.

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