Expandable curvilinear strut arrangement for deployment with a catheter to repair an aneurysm

Abstract

The vasoocclusive apparatus can be used in a method of interventional therapy and vascular surgery by inserting the apparatus into a portion of a vasculature, for treatment of a body vessel such as an aneurysm in conjunction with a secondary vasoocclusive device to be placed within the vessel. The vasoocclusiveVasooclusive apparatus includes a plurality of strut members connected together at a central hub that extend from a collapsed position to an expanded configuration to cross the neck of the aneurysm, dividing the neck into smaller openings, allowing the deployment of the secondary vasoocclusive device within the aneurysm but preventing migration of the secondary vasoocclusive device from the aneurysm. The strut members can be made from a twisted cable of strands of a superelastic material, such as a shape memory nickel titanium alloy, with at least one radiopaque strand. A shape memory collar is provided for detachably mounting the vasoocclusive apparatus to a pusher member and for detaching the vasoocclusive apparatus for deployment when a desired placement within an aneurysm to be treated and out of a parent vessel is achieved.

1. An occlusive apparatus for treatment of a body vessel, the vessel having a dome portion and a neck opening into the vessel, the apparatus comprising:
 a plurality of strut members centrally connected together and having separate unconnected free ends that are, said plurality of strut members including a stem, and said plurality of strut members being adapted to be deployed within the vessel and that to extend radially and curvilinearly from a collapsed configuration to an expanded configuration to cross the neck of the vessel, dividing the neck into smaller openings, wherein said plurality of strut members are connected together at a central hub, and extend from the central hub from said first collapsed configuration to said expanded configuration, and wherein said strut members are arrayed in a spiral configuration extending from said central hub; and 
 mounting means for detachably mounting the plurality of strut members to a placement catheter shaft and for detaching the plurality of strut members from the placement catheter shaft for deployment within the vessel to be treated, wherein said mounting means comprises a collar of shape memory material and said placement catheter shaft comprises a pusher member, and wherein said collar is disposed on one of the stem of the strut members and the pusher member and detachably connects the stem of the strut members with the pusher member. 
 
     
     
       2. The occlusive apparatus of  claim 1 , wherein said plurality of strut members are connected together at a central hub, and extend curvilinealy from the central hub from said first collapsed configuration to said expanded configuration. 
     
     
       3. The occlusive apparatus of  claim 2 , wherein said strut members are arrayed in a spiral configuration extending from said central hub. 
     
     
       4. The occlusive apparatus of  claim 2 , wherein said strut members have an umbrella-like configuration of spokes extending from the central hub. 
     
     
       5. The occlusive apparatus of  claim 4 , wherein said strut members additionally are crosslinked to adjacent strut members. 
     
     
       6. The occlusive apparatus of claim  2  1, wherein said strut members are randomly arranged. 
     
     
       7. The occlusive apparatus of  claim 1 , wherein said strut members are made from a twisted cable comprising strands of a superelastic material. 
     
     
       8. The occlusive apparatus of  claim 7 , wherein said cable further comprises at least one radiopaque strand of a metal selected from the group consisting of platinum, tungsten and gold. 
     
     
       9. The occlusive apparatus of  claim 1 , wherein said strut members are made from a twisted cable comprising strands of a shape memory nickel titanium alloy. 
     
     
       10. The occlusive apparatus of  claim 9 , wherein said strut members are heat treated to remain superelastic. 
     
     
       11. The occlusive apparatus of  claim 9 , wherein said strut members are heat treated to have shape memory behavior such that the alloy is highly flexible at a temperature appropriate for introduction into the body via a placement catheter, and after placement in the vessel, the apparatus will assume said expanded configuration. 
     
     
       12. The occlusive apparatus of  claim 1 , further comprising mounting means for detachably mounting the plurality of strut members to a placement catheter shaft and for detaching the plurality of strut members from the placement catheter shaft for deployment within the vessel to be treated. 
     
     
       13. The occlusive apparatus of claim  12  1, wherein said mounting means comprises a collar of shape memory material and said placement catheter shaft pusher member comprises a fiber optic pusher member, and wherein said collar is disposed on one of the occlusive apparatus and the fiber optic pusher member and connects the occlusive apparatus and the fiber optic pusher member. 
     
     
       14. The occlusive apparatus of  claim 13 , wherein said collar can be heated to be induced to assume a configuration disconnecting the occlusive apparatus plurality of strut members and the fiber optic pusher member. 
     
     
       15. The occlusive apparatus of  claim 14 , wherein said fiber optic pusher member is connected to an optical light source for conducting coherent light energy to the collar to heat the collar to induce the collar to detach the occlusive device plurality of strut members from the fiber optic pusher member. 
     
     
       16. The occlusive apparatus of  claim 13  An occlusive apparatus for treatment of a body vessel, the vessel having a dome portion and a neck opening into another vessel, the apparatus comprising:
 a plurality of strut members centrally connected together, said plurality of strut members including a stem, and said plurality of strut members being adapted to be deployed within the vessel and to extend radially and curvilinearly from a collapsed configuration to an expanded configuration to cross the neck of the vessel, dividing the neck into smaller openings, wherein said central hub comprises a stem having includes a proximal end adjacent to said strut members and a distal end, and further comprising a coil mechanically attached to the distal end of the stem; and 
 mounting means for detachably mounting the plurality of strut members to a placement catheter shaft and for detaching the plurality of strut members from the placement catheter shaft for deployment within the vessel to be treated, wherein said mounting means comprises a collar of shape memory material and said placement catheter shaft comprises a pusher member, and wherein said collar is disposed on one of the stem of the strut members and the pusher member and detachably connects the stem of the strut members with the pusher member. 
 
     
     
       17. The occlusive apparatus of claim  16  13, wherein the distal end of the fiber optic pusher member has a distal end having a surface defining a plurality of ridges. 
     
     
       18. The occlusive apparatus of  claim 1 , wherein said apparatus is formed of a shape memory plastic material. 
     
     
       19. A vasoocclusive apparatus for treatment of an aneurysm in the vasculature in conjunction with a secondary vasoocclusive device to be placed within the aneurysm, the aneurysm having a dome portion and a neck opening into a parent vessel, the apparatus comprising:
 a plurality of strut members centrally connected together and having separate unconnected free ends adapted to be deployed within the aneurysm, said plurality of strut members including a stem, and said strut members extending radially and curvilinearly from a collapsed configuration to an expanded configuration to cross the neck of the aneurysm, dividing the neck into smaller openings, allowing the deployment of the secondary vasoocclusive device within the aneurysm and preventing migration of the deployed secondary vasoocclusive device from the aneurysm into the parent vessel, wherein said plurality of strut members are connected together at a central hub, and extend radially and curvilinearly from the central hub from said first collapsed configuration to said expanded configuration, and wherein said strut members are arrayed in a spiral configuration extending from said central hub; and 
 mounting means for detachably mounting the plurality of strut members to a pusher member and for detaching the plurality of strut members from the pusher member for deployment within the vessel to be treated, wherein said mounting means comprises a collar of shape memory material disposed on one of the stem of the plurality of strut members and the pusher member and detachably connecting the stem of the plurality of strut members with the pusher member. 
 
     
     
       20. The vasoocclusive apparatus of  claim 19 , wherein said plurality of strut members are connected together at a central hub, and extend radially from the central hub from said first collapsed configuration to said expanded configuration. 
     
     
       21. The vasoocclusive apparatus of  claim 20 , wherein said strut members are arrayed in a spiral configuration extending from said central hub. 
     
     
       22. The vasoocclusive apparatus of  claim 20 , wherein said strut members have an umbrella-like configuration of spokes extending from the central hub, said strut members additionally are crosslinked to adjacent strut members. 
     
     
       23. The occlusive apparatus of claim  20  19, wherein said strut members are randomly arranged. 
     
     
       24. The vasoocclusive apparatus of  claim 19 , wherein said strut members are made from a twisted cable comprising strands of a superelastic material. 
     
     
       25. The vasoocclusive apparatus of  claim 24 , wherein said cable further comprises at least one radiopaque strand of a metal selected from the group consisting of platinum, tungsten and gold. 
     
     
       26. The vasoocclusive apparatus of  claim 19 , wherein said strut members are made from a twisted cable comprising strands of a shape memory nickel titanium alloy. 
     
     
       27. The occlusive apparatus of  claim 26 , wherein said strut members are heat treated to remain superelastic. 
     
     
       28. The occlusive apparatus of  claim 26 , wherein said strut members are heat treated to have shape memory behavior such that the alloy is highly flexible at a temperature appropriate for introduction into the body via a catheter, and after placement in the vessel, the apparatus will assume said expanded configuration. 
     
     
       29. The vasoocclusive apparatus of  claim 19 , further comprising mounting means for detachably mounting the plurality of strut members to a pusher member and for detaching the plurality of strut members from the pusher member for deployment within the vessel to be treated. 
     
     
       30. The vasoocclusive apparatus of  claim 29 , wherein said mounting means comprises a collar of shape memory material disposed on one of the vasoocclusive apparatus and the pusher member and connecting the vasoocclusive apparatus and the pusher member. 
     
     
       31. The vasoocclusive apparatus of claim  30  19, wherein said collar can be heated to be induced to assume a configuration disconnecting the occlusive apparatus plurality of strut members and the pusher member. 
     
     
       32. The vasoocclusive apparatus of  claim 31 , wherein the pusher member comprises a fiber optic catheter shaft connected to an optical light source for conducting coherent light energy to the collar to heat the collar to induce the collar to detach the occlusive device plurality of strut members from the fiber optic catheter shaft. 
     
     
       33. The vasoocclusive apparatus of  claim 20  A vasoocclusive apparatus for treatment of an aneurysm in the vasculature, the aneurysm having a dome portion and a neck opening into a parent vessel, the apparatus comprising:
 a plurality of strut members centrally connected together and having separate unconnected free ends adapted to be deployed within the aneurysm, said plurality of strut members including a stem, and said strut members extending radially and curvilinearly from a collapsed configuration to an expanded configuration to cross the neck of the aneurysm, dividing the neck into smaller openings, wherein said central hub comprises a stem having includes a proximal end adjacent to said strut members and a distal end, and further comprising a coil soldered to the distal end of the stem; and 
 mounting means for detachably mounting the plurality of strut members to a pusher member and for detaching the plurality of strut members from the pusher member for deployment within the vessel to be treated, wherein said mounting means comprises a collar of shape memory material disposed on one of the stem of the plurality of strut members and the pusher member and detachably connecting the stem of the plurality of strut members with the pusher member. 
 
     
     
       34. The vasoocclusive apparatus of claim  33  32, wherein the distal end of the fiber optic catheter shaft has a distal end having a surface defining a plurality of ridges. 
     
     
       35. A method of closing and occluding an opening of an aneurysm from a parent blood vessel, comprising the steps of:
 attaching an occlusive apparatus having radial members extending from a central hub to the distal end of a linear pusher device;   enclosing the pusher device and occlusive apparatus in a lumen of a catheter, with the pusher device proximal of the occlusive apparatus;   positioning the catheter so that the distal opening of the catheter is in the opening between the aneurysm and the parent blood vessel;   pushing the occlusive apparatus into the aneurysm by extending the pusher device towards the distal end of the catheter; and   disconnecting the occlusive apparatus from the pusher device, thereby deploying the occlusive apparatus within the aneurysm and at least partially occluding the opening between the aneurysm and the parent blood vessel   
     
     
       36. The method of  claim 35 , wherein said step of disconnecting the occlusive apparatus from the pusher device comprises causing energy to be transmitted through the pusher device to release the connection between the pusher device and the occlusive apparatus. 
     
     
       37. The method of  claim 35 , further including the steps of:
 attaching a secondary occlusive apparatus to the distal end of a linear pusher device;   enclosing the pusher device and secondary occlusive apparatus in a lumen of a catheter, with the pusher device proximal of the secondary occlusive apparatus;   positioning the catheter so that the distal opening of the catheter is in the opening between the aneurysm and the parent blood vessel;   pushing the secondary occlusive apparatus into the aneurysm through said first occlusive apparatus by extending the pusher device towards the distal end of the catheter; and   disconnecting the secondary occlusive apparatus from the pusher device, thereby deploying the secondary occlusive apparatus within the aneurysm, whereby said first occlusive apparatus prevents migration of said secondary vasoocclusive device from the aneurysm into the parent blood vessel.   
     
     
       38. A method of closing and occluding an opening of an aneurysm from a parent blood vessel, comprising the steps of:
 deploying a first occlusive apparatus within the aneurysm and at least partially occluding the opening between the aneurysm and the parent blood vessel; and   deploying a secondary occlusive apparatus through said first occlusive apparatus within the aneurysm, whereby said first occlusive apparatus prevents migration of said secondary vasoocclusive device from the aneurysm into the parent blood vessel.   
     
     
       39. A method of closing and occluding an opening of an aneurysm from a parent blood vessel, comprising the steps of:
 attaching a first occlusive apparatus having radial members extending from a central hub to the distal end of a linear pusher device;   enclosing the pusher device and first occlusive apparatus in a lumen of a catheter, with the pusher device proximal of the first occlusive apparatus;   positioning the catheter so that the distal opening of the catheter is in the opening between the aneurysm and the parent blood vessel;   pushing the first occlusive apparatus into the aneurysm by extending the pusher device towards the distal end of the catheter;   disconnecting the first occlusive apparatus from the pusher device, thereby deploying the first occlusive apparatus within the aneurysm and at least partially occluding the opening between the aneurysm and the parent blood vessel;   attaching a secondary occlusive apparatus to the distal end of a linear pusher device;   enclosing the pusher device and secondary occlusive apparatus in a lumen of a catheter, with the pusher device proximal of the secondary occlusive apparatus;   positioning the catheter so that the distal opening of the catheter is in the opening between the aneurysm and the parent blood vessel;   pushing the secondary occlusive apparatus into the aneurysm through said first occlusive apparatus by extending the pusher device towards the distal end of the catheter; and   disconnecting the secondary occlusive apparatus from the pusher device, thereby deploying the secondary occlusive apparatus within the aneurysm, whereby said first occlusive apparatus prevents migration of said secondary vasoocclusive device from the aneurysm into the parent blood vessel.   
     
     
       40. The method of  claim 39 , wherein said step of disconnecting the first occlusive apparatus from the pusher device comprises causing energy to be transmitted through the pusher device to release the connection between the pusher device and the first occlusive apparatus.