Vascular closure methods and apparatuses

Abstract

A vascular closure device comprised of a sheath-delivered expandable, umbrella-like device with structural radial members with terminal and non-terminal hooks that engage the vessel wall. Unlike other vascular closure umbrella-type devices that effect closure by opening of the umbrella to cover an opening, the present invention effects closure of the aperture with closure of the umbrella. The closure can be maintained by a retainer lock that slides down the members, causing contraction, bringing the members into a compressed configuration (e.g., a parallel orientation of linear members) and the wound edges together, permitting immediate vascular closure and healing of the blood vessel. The device can be delivered and recovered by an intravascular sheath.

1 ) A tissue closure device, comprising: 
 a) A junction body;    b) A plurality of tissue engagement elements, each having first and second ends, each mounted with the junction body near its first end in a manner that allows the tissue engagement elements to assume first and second configurations, and each comprising a portion spaced from the first end adapted to engage the tissue in both the first and second configurations, wherein: 
 i) In the first configuration, the second ends of the tissue engagement elements are spaced from each other by at least a first distance;  
 ii) In the second configuration, the second ends of the tissue engagement elements are spaced from each other by no more than a second distance, where the second distance is less than the first distance.  
   
   
   
       2 ) A tissue closure device, comprising a plurality of tissue engagement elements, mounted with each other such that in a first compressed configuration the tissue engagement elements can pass through a tissue opening to be closed, and such that in a second compressed configuration the tissue engagement elements bring the edges of the opening into apposition, and such that in an expanded configuration the tissue engagement elements span the opening, wherein the tissue engagement elements engage the tissue in both the compressed configuration and in the expanded configuration.  
   
   
       3 ) A device as in  claim 2 , wherein the tissue engagement elements comprise hooks.  
   
   
       4 ) A device as in  claim 2 , wherein the tissue engagement elements comprise wires each having a hook at a first end and slidably mounted with a lock device at a second end, wherein the wires assume the expanded configuration when not constrained by the lock device and assume the compressed configuration when constrained by the lock device.  
   
   
       5 ) A device as in  claim 4 , wherein the wires mount together at their second ends with a string receiving element adapted to engage a string such that tension on the string opposed to force on the lock device urges the wires through the lock device substantially along the direction of the tension on the string.  
   
   
       6 ) A tissue closure device, comprising: 
 a) A junction element, having a string engagement portion;    b) A plurality of members, where each member has a tissue engagement feature at a first end, and mounted with the junction element such that the members extend away from the junction element defining a truncated cone;    c) A lock element comprising a collar defining an interior passage, wherein passage of the junction element through the interior passage manipulates the members such that the area of the base of the truncated cone defined by the members is reduced.    
   
   
       7 ) A device as in  claim 6 , wherein the members comprise wires each having a hook at its first end.  
   
   
       8 ) A device as in  claim 6 , wherein the members comprise wires each having a plurality of hooks at its first end.  
   
   
       9 ) A device as in  claim 6 , wherein the lock element comprises a tissue engagement portion adapted to engage tissue over an area more than three times the area of the interior passage.  
   
   
       10 ) A device as in  claim 6 , wherein the junction element comprises a collar defining an interior passage suitable for passage of a guidewire therethrough.  
   
   
       11 ) A device as in  claim 6 , wherein each member further comprises one or more secondary tissue engagement features mounted with the member not at the first end.  
   
   
       12 ) A device as in  claim 6 , wherein the secondary tissue engagement members comprise projections from the member oriented toward the first end.  
   
   
       13 ) A device as in  claim 6 , further comprising a covering extending between the members.  
   
   
       14 ) A device as in  claim 6 , wherein the covering comprises a therapeutic material eluted when the device is placed in tissue.  
   
   
       15 ) A device as in  claim 6 , wherein the members comprise elongated diamond shaped elements.  
   
   
       16 ) A device as in  claim 6 , wherein the members are connected to each other by intermember struts.  
   
   
       17 ) A tissue closure device, comprising: 
 a) A junction element, having a string engagement portion;    b) A plurality of members, where each member has a tissue engagement feature at a first end, and mounted with the junction element such that the members extend away from the junction element defining a truncated cone, and having one or more secondary tissue engagement features mounted with the member and oriented toward the first end.    
   
   
       18 ) A device to close openings in blood vessels comprising an expandable umbrella-like device that in the compressed state resides in a sheath; after being expelled from the sheath assumes a planar or conical shape; after being brought into contact with a vessel wall engages the vessel wall; and can be collapsed to bring the edges of the opening into apposition.  
   
   
       19 ) A method of closing an opening in tissue, comprising: 
 a) passing a device, as in  claim 2 , while in the first compressed condition through a sheath that penetrates the proximal surface of the tissue;    b) expelling the device from the sheath into space beyond the proximal surface of the tissue such that the device assumes the expanded configuration;    c) manipulating the device such that the tissue engagement elements engage the tissue;    d) causing the device to assume the second compressed configuration, bringing the edges of the opening into apposition.    
   
   
       20 ) A method as in  claim 19 , further comprising configuring the device such that it will remain in the second compressed configuration.  
   
   
       21 ) A method as in  claim 19 , wherein causing the device to assume the second compressed configuration comprises applying traction to the device.  
   
   
       22 ) A device as in  claim 6 , wherein the junction element defines a lumen suitable for passage of a guidewire therethrough.  
   
   
       23 ) A device as in  claim 2 , wherein the tissue engagement elements comprise a shape memory material such that the tissue engagement elements assume the expanded configuration unless forced to another configuration.  
   
   
       24 ) A method of as in  claim 19 , wherein: 
 a) The device comprises a string attachment portion, to which a string is attached;    b) Manipulating the device such that the tissue engagement elements engage the tissue comprises pulling the string to encourage the device towards the tissue;    c) Causing the device to assume the second compressed configuration comprises passing the string through a central passageway of a locking element, passing the locking element down the string to the device, pulling the string such that a portion of the device engages the locking element, which engagement causes the device to assume the second compressed configuration.    
   
   
       25 ) A tissue closure device as in  claim 2 , wherein 
 a) the tissue engagement elements comprise elongated members, where each elongated member defines a first portion and a second portion along the length of the member, and are mounted with each other near the boundaries of the first and second portions of the members;    b) each tissue engagement element is shaped such that, absent external restraining force, the first portion and second portion of the member form an angle less than 180 degrees to each other, and the mounting of the tissue engagement elements is such that, when the first portions of the members are substantially parallel to each other, the second portions extend approximately radially outward from the mounting, defining the expanded configuration;    c) each tissue engagement element comprises a resilient material, such that the members can be forced to a configuration where the first portions of the members and the second portions of the members can be contemporaneously contained within a sheath, defining the compressed configuration.