Apparatus and method for sealing a vascular puncture
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.
1 . A sealant delivery system for closing a puncture in a vessel wall, the sealant delivery system comprising:
an inner catheter extending through an outer catheter and having an expandable structure at a distal end thereof; and,
a handle portion at a proximal end of the inner catheter operatively connected to and movable with the outer catheter, the handle portion having a tension indicator configured to indicate information associated with an amount of tension being applied to the vessel wall by the expandable structure;
wherein the tension indicator comprises a sliding piece disposed entirely within the handle portion and operatively coupled to the inner catheter such that the sliding piece is movable relative to the handle portion based on the tension applied to the vessel wall by the expandable structure.
2 . The sealant delivery system of claim 1 , wherein the tension indicator comprises a visual cue to a user when proper tension is applied on the expandable structure.
3 . The sealant delivery system of claim 2 , wherein the visual cue is exposed through a window provided in the handle portion.
4 . The sealant delivery system of claim 1 , wherein the tension indicator comprises a tension spring, wherein the tension indicator can move in a distal direction relative to the handle portion when a force on the expandable structure exceeds a pre-load on the tension spring.
5 . The sealant delivery system of claim 1 , wherein the inner catheter is configured to receive a sealant positionable therein near a distal end thereof proximal to the expandable structure.
6 . The sealant delivery system of claim 5 , further comprising a deployment actuator configured to both deploy the sealant within the puncture and to tamp the sealant against the vessel wall surrounding the puncture, wherein the handle portion further includes a lockout feature to prevent the deployment actuator from being actuated unless a predetermined amount of tension is being applied to the vessel wall by the expandable structure.
7 . The sealant delivery system of claim 6 , wherein the deployment actuator comprises a first visual indication that becomes visible through a window in the handle portion after at least a portion of the sealant has been exposed by the outer catheter being retracted in the first direction.
8 . The sealant delivery system of claim 7 , wherein the deployment actuator comprises a second visual indication that becomes visible through the window in the handle portion after the inner catheter is moved in the second direction to tamp the sealant.
9 . The sealant delivery system of claim 1 , wherein tension is adjustable via the handle portion.
10 . The sealant delivery system of claim 1 , further comprising a sheath adapter having an attachment structure, wherein the attachment structure defines a passageway for releasable attachment to a procedural sheath by positioning a side port or an irrigation line of the procedural sheath into the passageway of the attachment structure.
11 . A system for closing a puncture, the system comprising:
a housing;
a first rack member positioned within the housing and slidable within the housing;
a sealant sleeve coupled to the first rack member and movable with the first rack member;
a second rack member positioned within the housing and slidable within the housing;
a support member coupled to the second rack member and movable with the first rack member, and wherein at least a portion of the support member is positioned within a lumen of the sealant sleeve;
a sealant positioned in a distal end of the sealant sleeve, and wherein a distal end of the support member is positioned adjacent a proximal end of the sealant; and
a deployment actuator configured to both:
engage the first rack member to actuate the first rack member in a first direction;
engage the second rack member to actuate the second rack member in a second direction opposite the first direction;
wherein the deployment actuator includes a first actuation feature configured to actuate the first rack member and wherein the deployment actuator includes a second actuation feature configured to actuate the second rack member, and wherein the second actuation feature of the deployment actuator is spaced from the first actuation feature of the deployment actuator such that the first actuation feature of the deployment actuator is configured to engage an actuation feature of the first rack member before the second actuation feature of the deployment actuator engages an actuation feature of the second rack member.
12 . The system of claim 11 , wherein actuation of the first rack member in the first direction retracts the sealant sleeve, thereby exposing at least a portion of the sealant; and wherein actuating the second rack member in the second direction causes the support member to tamp the sealant.
13 . The system of claim 12 , wherein the deployment actuator comprises a first visual indication that becomes visible through a window in the housing after at least a portion of the sealant has been exposed by the sealant sleeve being retracted in the first direction.
14 . The system of claim 13 , wherein the deployment actuator comprises a second visual indication that becomes visible through the window in the housing after the support member is moved in the second direction to tamp the sealant.
15 . The system of claim 11 , wherein a proximal end of the deployment actuator is pivotably coupled to the housing.
16 . The system of claim 11 , wherein the second actuation feature of the deployment actuator is provided at a distal end thereof and is configured to actuate the second rack member in the second direction.
17 . The system of claim 11 , wherein the second actuation feature of the deployment actuator includes a wall and wherein the actuation feature of the second rack member includes a ramp.
18 . The system of claim 17 , wherein the first actuation feature of the deployment actuator is provided at a distal end thereof and is configured to actuate the first rack member in the first direction.
19 . The system of claim 11 , wherein the housing comprises a sheath adapter at a distal end thereof, the sheath adapter having an attachment structure defining a passageway for releasable attachment to a procedural sheath by positioning a side port of an irrigation line of the procedural sheath into the passageway of the attachment structure.
20 . The system of claim 11 , further comprising an inner catheter extending through the sealant sleeve, wherein the inner catheter comprises an expandable structure at a distal end thereof.
21 . The system of claim 20 , wherein the housing comprises a lockout mechanism configured to prevent the deployment actuator from being actuated when the expandable structure is in an expanded state.
22 . The system of claim 20 , wherein the housing 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.
23 . The system of claim 20 , wherein the housing comprises a tension indicator configured to indicate information associated with an amount of tension being applied to a vessel wall by the expandable structure.
24 . The system of claim 23 , wherein the tension indicator comprises a sliding piece disposed entirely within the housing and operatively coupled to the inner catheter such that the sliding piece is movable relative to the housing based on the tension applied to the vessel wall by the expandable structure.
25 . The system of claim 24 , wherein the housing comprises a lockout feature to prevent the deployment actuator from being actuated unless a predetermined amount of tension is being applied to the vessel wall by the expandable structure.
26 . The system of claim 25 , wherein the lockout feature is operatively coupled to the sliding piece of the tension indicator.