Apparatus and methods for sealing a vascular puncture
Inventors
Hundertmark, Ronald R. • Uchida, Andy H. • Zilversmit, Moshe • Fiscella, David L. • Fell, Brandon • Ku, Vincent
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10245012-B2
Publication Date
2019-04-02
Expiration Date
Abstract
An apparatus for sealing a puncture through a vessel wall including a positioning assembly, a sheath releasably engaged with the positioning assembly, and a support member axially advanceable through the sheath. The positioning assembly includes a positioning element positioned at a distal portion of the positioning assembly and a sealant disposed at a distal portion of the positioning assembly. The sheath guides the sealant and positioning assembly to the puncture in the vessel wall.
Core Innovation
The invention relates to an apparatus for sealing a puncture through a vessel wall. The apparatus includes a positioning assembly with an expandable member disposed at a distal portion of the positioning assembly, where the expandable member is configured to move between an unexpanded state and an expanded state. The positioning assembly is configured to move axially within a support member.
The apparatus further includes a tubular member through which the support member is axially advanceable. A handle includes an outer housing portion and a depressible button, where the button is provided in a first position in which the button is operatively coupled to the tubular member and operatively uncoupled from the support member. The button is moveable from the first position to a second position so as to retract the tubular member and advance the support member, with a partially depressed position that couples the button to the support member and positions the tubular member proximally compared to its first position.
When the button is in the partially depressed position, the sealant disposed at the distal portion of the positioning assembly is at least partially exposed, and the support member is in substantially the same position as it is when the button is in the first position. The documented embodiments describe sequential mechanical actuation in which retracting a tubular member relative to a sealant sleeve exposes the sealant, and advancing the support member tamp/compresses sealant adjacent the vessel wall after expansion and collapse of the positioning member.
Additional described features include rack-and-pinion deployment states to create retraction/advance timing and optional locking or catch arrangements to inhibit unintended re-advancement and provide positioning or visual confirmation. The apparatus is documented with operative methods for delivering sealant to an arteriotomy site and leaving the sealant adjacent a vessel wall after the expandable positioning element is collapsed. The disclosed mechanical arrangements include an introducer sheath to guide the components to the puncture and embodiments that use hub abutment and sleeve retraction to control sealant exposure, including optional bleed-back confirmation systems.
Claims Coverage
The independent claim identified is directed to a vascular puncture sealing apparatus with a handle actuation sequence that first retracts a tubular member and then advances a support member via a partially depressed button position, producing sealant exposure at the distal positioning assembly. The dependent claims refine the coupling mechanics, the relative motion of components between button positions, sealant interaction, and optional locking to prevent proximal movement.
Handle with depressible button for staged coupling and sealant exposure
A handle comprising an outer housing portion and a depressible button, wherein the button is provided in a first position in which the button is operatively coupled to the tubular member and operatively uncoupled from the support member, and wherein the button is moveable relative to the outer housing portion from the first position to a second position to retract the tubular member and advance the support member, and wherein the button has a partially depressed position in which the button is operatively coupled to the support member, the tubular member is positioned proximally compared to its position when the button is in the first position, a sealant disposed at the distal portion of the positioning assembly is at least partially exposed, and the support member is in substantially the same position as it is when the button is in the first position.
Axial movement of positioning assembly within support member
A support member, the positioning assembly configured to move axially within the support member.
Expandable positioning assembly at a distal portion
A positioning assembly including an expandable member disposed at a distal portion of the positioning assembly, the expandable member configured to move between an unexpanded state and an expanded state.
Tubular member through which support member is advanceable
A tubular member through which the support member is axially advanceable.
Rack-and-pinion coupling at the first button position
When the button is in the first position, the tubular member is operatively coupled to the button via a first rack and at least one pinion.
Rack-and-pinion coupling at the partially depressed button position
When the button is partially depressed, the support member is operatively coupled to the button via a second rack and the at least one pinion.
Rack and pinion shapes to create a delay between retraction and advancement
The shapes of at least one of the first rack, second rack, and pinion vary to create a delay between retraction of the tubular member and advancement of the support member.
Support member compresses sealant upon distal movement
The support member is configured to compress the sealant when the support member is moved distally.
Locking feature engaging a rack to prevent proximal support movement
A locking feature is configured to engage the second rack to prevent proximal movement of the support member.
Across the independent claim and identified dependent refinements, the central claim coverage is the staged handle actuation using a depressible button with first/partially depressed positions that shift operative coupling between the tubular member and the support member, thereby exposing sealant at the distal portion. Additional covered refinements include rack-and-pinion coupling in different button positions, rack/pinion shape variation to create delay between tubular retraction and support advancement, compression of the sealant by distal movement of the support member, and optional locking to prevent proximal movement of the support member.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?