DEVICES AND METHODS TO TREAT VASCULAR DISSECTIONS

• US 20130253632A1
• Filed: 11/16/2011
• Published: 09/26/2013
• Est. Priority Date: 11/17/2010
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Schreck, Stefan G.
• Granted Patent: US 9,393,100 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

A device system and method for the treatment of aortic dissections comprising placing a stent in the true lumen and displacing the blood in the false lumen with an inflatable bag.

Claims

1. A method of treating an aortic dissection having a true lumen and a false lumen, comprising:

deploying a support structure in the true lumen of a blood vessel adjacent to or overlapping a portion of the dissection to maintain the true lumen in an open state;

advancing a bag in a collapsed state as part of a catheter with a fill lumen into the false lumen; and

inflating the bag while said bag is in the false lumen using a filling medium provided to said bag through the fill lumen; and

;

separating the bag from the catheter while maintaining the bag in the false lumen.

2. The method of claim 1, wherein the support structure is a balloon expandable stent or a self-expandable stent.

3. The method of claim 1, comprising sealing at least one opening into the dissection with a support structure that is partially covered with a graft.

5. The method of claim 1, comprising inflating the bag with an inflation medium through the catheter and detaching the bag from the catheter after inflating the bag.

7. The method of claim 1, comprising inflating the bag with an inflation medium comprising a polymer or monomer that crosslinks after injection.

8. The method of claim 1, wherein the polymer comprises polyethylene glycol comprising advancing the bag into the false lumen through an opening closer to a downstream end of the false lumen than an upstream end of the false lumen.

11. The method of claim 1, wherein the bag is made from ePTFE, polyurethane, Dacron, woven or knitted biocompatible fibers, or other thin-wall biocompatible material.

14. The method of claim 1, wherein the bag comprises an embolization agent.

17. The method of claim 1, further comprising monitoring a pressure in the bag during inflation.

18. The method of claim 1, wherein an inflation medium for inflating the bag is liquid during injection and changes phase to a solid after injection.

19. The method of claim 1, comprising inflating the bag to displace the blood in the false lumen after deploying the support structure in the true lumen of the blood vessel adjacent to or overlapping a portion of the dissection.

4. (canceled)

6. (canceled)

9. (canceled)

10. (canceled)

12. (canceled)

13. (canceled)

15. (canceled)

16. (canceled)

20-38. -38. (canceled)

39. A device system for treating aortic dissections having a false lumen, comprising:

a support structure for deployment in a true lumen of an aorta; and

an inflatable structure for deployment in the false lumen of the aorta;

wherein;

the support structure is supported in a compressed state when the device is in a pre-deployment state and during delivery to the true lumen;

the support structure is expanded in the aorta when deployed to approximately the diameter of a true lumen of the aorta;

the inflatable structure is supported in a compressed state when the device is in a pre-deployment state and during advancement of the inflatable structure into the false lumen; and

the inflatable structure is inflated in the false lumen to displace the blood in the false lumen when deployed.

40. A device system of claim 39, wherein the support structure is a balloon expandable stent or a self-expanding stent.

41. The device system of claim 39, wherein the support structure is partially covered with a graft to at least substantially seal an entry point of the dissection.

42. The device system of claim 39, wherein a flap of the dissection is sandwiched between the support structure and the inflatable structure after the support structure and the inflatable structure have been deployed.

43. The device system of claim 39, wherein the stent is sized to extend along the entire length of the dissection.

46. The device system of claim 39, further comprising an inflation medium for inflating the inflatable structure comprising a polymer or monomer that crosslinks after injection.

54. The device system of claim 39, wherein an inflation medium is injected into the inflatable structure through a detachable fill tube.

55. The device system of claim 39, further comprising a delivery catheter supporting the support structure and the inflatable structure in the pre-deployment state.

44. (canceled)

45. (canceled)

47-53. -53. (canceled)

56. A device system for treating aortic dissections having a false lumen, comprising:

a support structure for positioning in a true lumen of the aorta to support the true lumen when the support structure is deployed; and

an inflatable structure for positioning in the false lumen;

wherein;

the support structure is supported in a compressed state when the device is in a pre-deployment state and during delivery to the true lumen and expandable in the aorta to the approximate diameter of the true lumen;

the inflatable structure is supported in a compressed state when the device is in a pre-deployment state and during advancement into the false lumen and inflatable in the false lumen to displace the blood in the false lumen; and

the inflatable structure is detachable from the device system so that the inflatable structure can remain positioned within the false lumen after removal of the device system.

57-73. -73. (canceled)