Occlusion device for occluding an atrial auricula and method for producing same

Abstract

A self-expanding occlusion device for occluding an atrial auricula in the heart of a patient includes a braiding of thin wires or threads given a suitable profile form by means of a molding and heat treatment procedure. The occlusion device includes a proximal retention area, a distal retention area and a center section. The occlusion device holds securely in the atrial auricula of a patient in its expanded and implanted state without damaging the tissue of the patient's heart. The proximal retention area has a flanged area which positions at the inner walls of the atrial auricula when the occlusion device is in an expanded state in the atrial auricula to be occluded, and forms a force-fit connection with the inner walls of the atrial auricula, thus holding the implanted and expanded occlusion device in the atrial auricula, whereby the distal retention area closes the opening in the atrial auricula.

What is claimed is: 
     
       1. A self-expanding occlusion device comprising:
 a braiding of thin wires or threads given a predetermined form by means of a molding and heat treatment procedure, said braiding having:   a proximal retention area comprising a proximal end of the occlusion device that defines an opening to an interior of the occlusion device and a proximal flange biased to deflect towards a distal end of the occlusion device;   a distal retention area comprising the distal end of the occlusion device and a holder in which all ends of the wires or threads converge, the holder positioned interior of the distal end; and   a center section disposed between said proximal and said distal retention areas;   wherein the occlusion device can be introduced into the body of the patient in a collapsed state and positioned in a minimally invasive procedure using a catheter.   
     
     
       2. The occlusion device in accordance with  claim 1 , wherein said flanged area of said proximal retention area is configured to deflect towards said distal retention area when said occlusion device is in said expanded state in said target site. 
     
     
       3. The occlusion device in accordance with  claim 1 , wherein said distal retention area exhibits a recess in which said single holder is arranged. 
     
     
       4. The occlusion device in accordance with  claim 3 , wherein at least one connective element is furthermore provided in said recess at said distal retention area, whereby said connective element can engage with a catheter. 
     
     
       5. The occlusion device in accordance with  claim 1 , wherein said occlusion device is configured to be reversibly collapsible so that the expanded occlusion device can be collapsed by means of an explantation catheter. 
     
     
       6. The occlusion device in accordance with  claim 1 , wherein said braiding comprises a polymer. 
     
     
       7. The occlusion device in accordance with  claim 1 , wherein said occlusion device exhibits a mushroom-shaped profile. 
     
     
       8. The occlusion device in accordance with  claim 1 , wherein said occlusion device exhibits a barbell-shaped profile. 
     
     
       9. The occlusion device in accordance with  claim 1 , wherein said braiding collapses to a diameter of a catheter used in a minimally invasive surgical procedure. 
     
     
       10. The occlusion device in accordance with  claim 1 , further comprising a fabric insert. 
     
     
       11. The occlusion device in accordance with  claim 1 , wherein said distal retention area is flush with said opening of said target site when the occlusion device is in said expanded state. 
     
     
       12. The occlusion device in accordance with  claim 11 , wherein an edge of said distal retention area is flush with said opening of said target site when said occlusion device is in said expanded state. 
     
     
       13. An occlusion device comprising:
 a braiding comprising a plurality of filamentous members having first and second ends;   a proximal retention area comprising a proximal flange that is biased to deflect towards a distal end of the occlusion device and a proximal end of the occlusion device that is open to an interior of the occlusion device;   a distal retention area comprising the distal end of the occlusion device and an outer edge overlapping an opening of a target site when said occlusion device is in a deployed state;   a center section associating said proximal flange and said distal retention area; and   a holder bundling said first and second ends of said plurality of filamentous members together, said holder disposed substantially within said distal retention area when said occlusion device is in a deployed state.   
     
     
       14. The occlusion device of  claim 13  wherein said distal retention area is formed in a shape substantially similar to a shape of an umbrella. 
     
     
       15. The occlusion device of  claim 13  wherein said holder is disposed in a recess formed at said distal retention area. 
     
     
       16. The occlusion device of  claim 13  wherein said plurality of filamentous members comprise a shape-memory material. 
     
     
       17. The occlusion device of  claim 16  wherein said shape-memory material comprises a polymer. 
     
     
       18. The occlusion device of  claim 13  wherein said holder comprises a connective element. 
     
     
       19. The occlusion device of  claim 13  wherein said occlusion device is reversibly collapsible to a diameter of a catheter used in a minimally invasive procedure. 
     
     
       20. The occlusion device of  claim 13  further comprising a fabric insert. 
     
     
       21. A self-expanding occlusion device comprising:
 a structure of thin wires or threads of a shape memory material self-expandable to an expanded shape upon implantation, said structure having:   a proximal retention area comprising a proximal flange biased to deflect outward towards a distal end of the occlusion device, the thin wires or threads of the proximal retention area forming at least one opening;   a distal retention area forming a distal end of the occlusion device and a recess,   a holder in which opposing ends of at least one of the wires or threads of the structure converge, the holder being positioned within said recess; and   a center section disposed between said proximal and said distal retention areas;   wherein the occlusion device can be introduced into the body of the patient in a collapsed state and positioned in a minimally invasive procedure using a catheter.   
     
     
       22. The occlusion device in accordance with claim 21, wherein said distal flange is plate shaped when said occlusion device is in said expanded state in said target site. 
     
     
       23. The occlusion device in accordance with claim 21, wherein at least one connective element is provided in said recess at said distal retention area, whereby said connective element engages a catheter. 
     
     
       24. The occlusion device according to claim 23, wherein the connective element comprises an internal threading devised to engage with an insertion instrument. 
     
     
       25. The occlusion device in accordance with claim 21, wherein said occlusion device is configured to be reversibly collapsible so that the expanded occlusion device can be collapsed by means of an explantation catheter. 
     
     
       26. The occlusion device according to claim 21, wherein the distal retention area is configured as a distal umbrella, and the proximal retention area is configured as a proximal umbrella. 
     
     
       27. The occlusion device in accordance with claim 21, wherein said occlusion device exhibits a mushroom-shaped profile whereby the cap of the mushroom-shaped profile forms the proximal retention area. 
     
     
       28. The occlusion device in accordance with claim 21, wherein said occlusion device exhibits a barbell-shaped profile. 
     
     
       29. The occlusion device according to claim 21, wherein the proximal retention area is umbrella shaped, and the distal retention area is plate shaped. 
     
     
       30. The occlusion device in accordance with claim 21, wherein said occlusion device is collapsible to a diameter of a catheter used in a minimally invasive surgical procedure. 
     
     
       31. The occlusion device in accordance with claim 21, further comprising an insert. 
     
     
       32. The occlusion device according to claim 31, wherein the insert is a fabric insert. 
     
     
       33. The occlusion device according to claim 31, wherein the insert is arranged in the distal retention area. 
     
     
       34. The occlusion device according to claim 33, wherein the insert is stretched over at least a portion of the structure. 
     
     
       35. The occlusion device according to claim 31, wherein the holder comprises an internal threading devised to engage with an insertion instrument. 
     
     
       36. The occlusion device in accordance with claim 21, further comprising a tractive force exerted across the center section by the proximal retention area configured to hold the distal retention area at the opening of said target site, whereby said distal retention area is configured to be flush with said opening of said target site when the occlusion device is in said expanded state. 
     
     
       37. The occlusion device in accordance with claim 36, wherein an edge of said distal retention area is configured to be flush with said opening of said target site when said occlusion device is in said expanded state. 
     
     
       38. The occlusion device in accordance with claim 21, wherein at least a portion of the structure comprises a braiding of the thin wires or threads. 
     
     
       39. An occlusion device comprising:
 a plurality of shape-memory filamentous members;   a self-expanding proximal retention area comprising a flange biased to deflect towards a distal end of the occlusion device and at least one opening therethrough;   a self-expanding distal area comprising an outer edge configured to overlap an opening of a target site when said occlusion device is in a deployed state;   a center section associating said proximal flange and said distal area; and   a holder bundling opposing ends of at least one of said plurality of filamentous members together, said holder disposed substantially proximal of a distal end of said occlusion device when said occlusion device is in a deployed state.   
     
     
       40. The occlusion device of claim 39, wherein said distal area is formed in a shape substantially similar to a shape of an umbrella. 
     
     
       41. The occlusion device according to claim 39, wherein the proximal flange is formed in a shape substantially similar to a shape of an umbrella. 
     
     
       42. The occlusion device of claim 39, wherein said holder is disposed in a recess formed at said distal area. 
     
     
       43. The occlusion device of claim 39, wherein said plurality of filamentous members comprise a metallic shape-memory material. 
     
     
       44. The occlusion device of claim 43, wherein said plurality of filamentous members comprise a polymeric shape-memory material. 
     
     
       45. The occlusion device of claim 39, wherein said holder comprises a connective element. 
     
     
       46. The occlusion device according to claim 45, wherein the connective element comprises an internal threading devised to engage with an insertion instrument. 
     
     
       47. The occlusion device of claim 39, wherein said occlusion device is reversibly collapsible to a diameter of a catheter used in a minimally invasive procedure. 
     
     
       48. The occlusion device of claim 39, further comprising an insert. 
     
     
       49. The occlusion device of claim 48, wherein the insert is a fabric insert. 
     
     
       50. The occlusion device of claim 48, wherein the insert is arranged in the distal area. 
     
     
       51. The occlusion device of claim 50, wherein the insert is stretched over at least a portion of the occlusion device. 
     
     
       52. The occlusion device of claim 39, further comprising a tractive force exerted across the center section by the proximal flange configured to hold the distal area at the opening of said target site, whereby said distal area is configured to be flush with said opening of said target site when the occlusion device is in said deployed state. 
     
     
       53. The occlusion device of claim 39, wherein said proximal flange is configured to deflect towards said distal area when said occlusion device is in said deployed state. 
     
     
       54. The occlusion device in accordance with claim 39, wherein at least a portion of the occlusion device comprises a braiding of the plurality of shape-memory filamentous members. 
     
     
       55. An occlusion device comprising:
 a plurality of shape-memory wires or threads;   a self-expanding proximal area having an opening formed therethrough and a flange folded towards a distal end of the occlusion device to form an open umbrella-like profile;   a self-expanding distal area having an outer edge configured to overlap an opening of a target site when said occlusion device is in a deployed state and a connective element that reversibly engages an insertion instrument, the connective element at least partially recessed from the distal end of the occlusion device when the occlusion device is in a deployed state and binding opposing ends of at least one of the plurality of shape-memory wires or threads; and   a central portion connecting the proximal area to the distal area.   
     
     
       56. The occlusion device of claim 55, wherein the connective element is provided in a recess formed in the distal area. 
     
     
       57. The occlusion device of claim 55, wherein at least a portion of the plurality of shape-memory wires or threads are braided. 
     
     
       58. The occlusion device of claim 55, wherein the distal area has an umbrella-like profile. 
     
     
       59. The occlusion device of claim 55, wherein the proximal area, central portion, and distal area form a barbell-shaped profile. 
     
     
       60. The occlusion device of claim 55, wherein the distal area has a plate-like profile. 
     
     
       61. The occlusion device of claim 55, wherein the self-expanding proximal area, central portion, and distal area are reversibly collapsible from an expanded deployed state to a collapsed state. 
     
     
       62. The occlusion device of claim 55, wherein the distal area comprises an insert.