Apparatus and Method for Sealing a Vessel Puncture Opening

Abstract

A device for sealing a puncture opening in a wall of a blood vessel may include a base frame including a first bi-stable material having a first stable state corresponding to a delivery configuration of the base frame, in which the base frame is retracted to have a relatively smaller overall profile, and a second stable state corresponding to a deployed configuration of the base frame, in which the base frame is extended to have a relatively larger overall profile. The base frame is sized to engage an interior surface of the blood vessel wall when in the deployed configuration. A sealing section is coupled to the base frame and includes a second bi-stable material having a first stable state corresponding to an initial configuration of the sealing section, in which the sealing section permits fluid flow, and a second stable state corresponding to a barrier configuration of the sealing section, in which the sealing section prevents fluid flow. The sealing section in the barrier configuration is sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration.

1 . A device for sealing a puncture opening in a wall of a blood vessel, the sealing device comprising:
 a base frame movable between a delivery configuration, in which the base frame is retracted to have a relatively smaller overall profile, and a deployed configuration, in which the base frame is extended to have a relatively larger overall profile, the base frame being sized to engage an interior surface of the blood vessel wall when in the deployed configuration, and the base frame being configured to have a first stable state corresponding to the deployed configuration; and   a sealing section coupled to the base frame and having an initial configuration which permits fluid flow through the sealing section and a barrier configuration which prevents fluid flow through the sealing section, the sealing section in the barrier configuration being sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration.   
   
   
       2 . The sealing device of  claim 1 , in which the sealing section comprises a bi-stable sealing structure having a first stable state corresponding to the initial configuration and a second stable state corresponding to the barrier configuration. 
   
   
       3 . The sealing device of  claim 2 , in which the sealing section comprises a plurality of braided sealing filaments. 
   
   
       4 . The sealing device of  claim 3 , in which the sealing filaments comprise an expandable material, wherein each filament has a smaller volume in the initial configuration and a larger volume in the barrier configuration. 
   
   
       5 . The sealing device of  claim 4 , in which the expandable material comprises a shape memory polymer that automatically moves from the initial configuration to the barrier configuration when the sealing section is disposed in the blood vessel. 
   
   
       6 . The sealing device of  claim 4 , in which the expandable material comprises an electroactive polymer that selectively moves from the initial configuration to the barrier configuration based on a current level supplied to the expandable material. 
   
   
       7 . The sealing device of  claim 2 , in which the sealing section comprises a plurality of slats, each slat being coupled to the base frame by a joint, each joint permitting the associated slat to move between initial and configuration positions, wherein the slats are spaced from one another in the initial configuration and wherein at least some of the slats contact one another to form a composite barrier in the barrier configuration. 
   
   
       8 . The sealing device of  claim 7 , in which each joint is formed of a bi-stable material to actuate the sealing section between the initial and barrier configurations. 
   
   
       9 . The sealing device of  claim 8 , in which the bi-stable material comprises an electroactive polymer. 
   
   
       10 . The sealing device of  claim 8 , in which the bi-stable material comprises a shape memory polymer. 
   
   
       11 . The sealing device of  claim 1 , in which the base frame includes an anchor section adapted to grip the blood vessel wall when the base frame is in the deployed configuration. 
   
   
       12 . The sealing device of  claim 1 , in which the sub-frame comprises a self-expanding stent. 
   
   
       13 . The sealing device of  claim 1 , in which the base frame comprises a bi-stable base frame having a first stable state corresponding to the delivery configuration and a second stable state corresponding to the deployed configuration. 
   
   
       14 . The sealing device of  claim 13 , in which the bi-stable base frame comprises a shape memory polymer that automatically actuates the base frame from the initial configuration to the deployed configuration. 
   
   
       15 . The sealing device of  claim 13 , in which the bi-stable base frame comprises an electroactive polymer that selectively actuates the base frame from the initial configuration to the deployed configuration in response to an activator. 
   
   
       16 . The sealing device of  claim 15 , in which the activator comprises a source of electric current. 
   
   
       17 . The sealing device of  claim 1 , in which the base frame comprises a plurality of radially oriented supports hingedly coupled to a stem so that the supports are pivotable between the delivery and deployed configurations, and in which the sealing section comprises a seal membrane coupled to the supports. 
   
   
       18 . The sealing device of  claim 17 , further comprising a series of pawls formed on the stem and a clamp ring configured to engage the pawls. 
   
   
       19 . A device for sealing a puncture opening in a wall of a blood vessel, the sealing device comprising:
 a base frame movable between a delivery configuration, in which the base frame is retracted to have a relatively smaller overall profile, and a deployed configuration, in which the base frame is extended to have a relatively larger overall profile, the base frame being sized to engage an interior surface of the blood vessel wall when in the deployed configuration, and the base frame being configured to have a first stable state corresponding to the deployed configuration; and   a sealing section coupled to the base frame and including a bi-stable material having a first stable state corresponding to an initial configuration of the sealing section, in which the sealing section permits fluid flow, and a second stable state corresponding to a barrier configuration of the sealing section, in which the sealing section prevents fluid flow, the sealing section in the barrier configuration being sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration.   
   
   
       20 . The sealing device of  claim 19 , in which the bi-stable material comprises a shape memory polymer. 
   
   
       21 . The sealing device of  claim 20 , in which the sealing section comprises braided sealing filaments formed of the shape memory polymer. 
   
   
       22 . The sealing device of  claim 20 , in which the sealing section comprises a plurality of slats, each slat being coupled to the base frame by a joint formed of the shape memory polymer, each joint permitting an associated slat to move between initial and configuration positions, wherein the slats are spaced from one another in the initial configuration and wherein at least some of the slats contact one another to form a composite barrier in the barrier configuration. 
   
   
       23 . The sealing device of  claim 19 , in which the bi-stable material comprises an electroactive polymer. 
   
   
       24 . The sealing device of  claim 23 , in which the sealing section comprises braided sealing filaments formed of the electroactive polymer. 
   
   
       25 . The sealing device of  claim 23 , in which the sealing section comprises a plurality of slats, each slat being coupled to the base frame by a joint formed of the electroactive polymer, each joint permitting an associated slat to move between initial and configuration positions, wherein the slats are spaced from one another in the initial configuration and wherein at least some of the slats contact one another to form a composite barrier in the barrier configuration. 
   
   
       26 . A device for sealing a puncture opening in a wall of a blood vessel, the sealing device comprising:
 a base frame including a first bi-stable material having a first stable state corresponding to a delivery configuration of the base frame, in which the base frame is retracted to have a relatively smaller overall profile, and a second stable state corresponding to a deployed configuration of the base frame, in which the base frame is extended to have a relatively larger overall profile, the base frame being sized to engage an interior surface of the blood vessel wall when in the deployed configuration; and   a sealing section coupled to the base frame and including a second bi-stable material having a first stable state corresponding to an initial configuration of the sealing section, in which the sealing section permits fluid flow, and a second stable state corresponding to a barrier configuration of the sealing section, in which the sealing section prevents fluid flow, the sealing section in the barrier configuration being sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration.   
   
   
       27 . The sealing device of  claim 26 , in which the first and second bi-stable materials comprise first and second shape memory polymers. 
   
   
       28 . The sealing device of  claim 27 , in which the first and second shape memory polymers expand in response to an elevated temperature. 
   
   
       29 . The sealing device of  claim 26 , in which the first and second bi-stable materials comprise first and second electroactive polymers operatively coupled to a source of electrical current. 
   
   
       30 . The sealing device of  claim 29 , in which the first and second electroactive polymers expand in response to a change in a current level provided by the electrical current source.