DEVICES, THERAPEUTIC COMPOSITIONS AND CORRESPONDING PERCUTANEOUS TREATMENT METHODS FOR AORTIC DISSECTION

• US 20120197284A1
• Filed: 01/31/2012
• Published: 08/02/2012
• Est. Priority Date: 01/31/2011
• Status: Active Grant

• Current Assignee: Nectero Medical, Inc.
• Original Assignee: Vatrix Medical, Inc.
• Inventors: Ogle, Matthew F., Carlyle, Wenda C., Anderson, Edward J., Reil, Todd D.
• Granted Patent: US 8,911,468 B2
• Time in Patent Office: Days
• US Class Current: 606/195
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence

Abstract

The methods and devices disclosed herein pertain to the percutaneous treatment of various forms of aortic dissection by at least partially filling the false lumen of the aortic dissection with a stabilization agent percutaneously and steps to decrease the size of the false lumen using the devices. Fluid maybe aspirated from the false lumen to decrease the volume of the false lumen. And the entrance opening between the true lumen and the false lumen may be sealed with a sealing agent such as a biocompatible adhesive. The medical devices disclosed herein generally comprise an extendable sealing element that is used in conjunction with a catheter to expand the true lumen while reducing the size of the false lumen. The device has the ability to aspirate and/or deliver fluid containing the stabilization agent into the false lumen.

Claims

1. A method for percutaneously treating aortic dissection in which diseased aorta comprises a true lumen, a false lumen, and an entrance opening between the true lumen and the false lumen, the method comprising,

at least partially filling the false lumen percutaneously with a stabilization agent that comprises a tissue stabilizer, a bioactive strength enhancers, a filler, an adhesive or combinations thereof.

2. The method of claim 1 further comprising percutaneously decreasing the volume of the false lumen.

3. The method of claim 2 wherein the volume of the false lumen is decreased by deploying an expandable device in the true lumen.

4. The method of claim 3 wherein the expandable device is a balloon.

5. The method of claim 2 wherein the volume of the false lumen is decreased by aspirating fluid from the false lumen.

6. The method of claim 1 wherein the filler comprises fibers, coils, and/or particulates that comprise metal, ceramics and/or polymers.

7. The method of claim 1 wherein the stabilization agent further comprises anti-calcification agent, crosslinking agents, growth factors, antibiotics, anti-inflammatory agents, or a combination thereof.

8. The method of claim 1 wherein the stabilization agent comprises an adhesive with a polymer precursor that cures following delivery.

9. The method of claim 1 wherein the stabilization agent comprises an epoxide, a hydrogel, resorbable fibers, proteins, a fibrous polysaccharide, a biocompatible adhesive, or a combination thereof.

10. The method of claim 1 wherein the filler comprises a resorbable polymer.

11. The method of claim 1 wherein the filler comprises bovine serum albumin, collagen, elastin, or a combination thereof.

12. The method of claim 1 wherein the stabilization agent further comprises pentagalloylglucose, an analog or derivative of pentagalloylglucose, a pharmaceutical salt of pentagalloylglucose, or a combination thereof.

13. A method for percutaneously treating aortic dissection in which diseased aorta comprises a true lumen, a false lumen, a lining between the true lumen and the false lumen, and an entrance opening between the true lumen and the false lumen, the method comprising,

removing fluid from the false lumen percutaneously to decrease the volume of the false lumen;

and

percutaneously sealing the entrance opening between the true lumen and the false lumen.

14. The method of claim 13 wherein the fluid is removed through the entrance opening.

15. The method of claim 13 wherein the fluid is removed by penetrating the lining between the true lumen and the false lumen and accessing the false lumen through the lining percutaneously.

16. The method of claim 13 wherein the fluid is removed after sealing the opening.

17. The method of claim 13 wherein the opening is sealed with a biocompatible adhesive.

18. The method of claim 13 further comprising sealing an exit opening between the true lumen and the false lumen.

19. A medical device comprising,

a device shaft comprising a lumen and a proximal end;

an extendable sealing element supported by the shaft comprising a sealing body, a by-pass channel extending through the sealing body, wherein the extendable sealing element is suitable for deployment in a true lumen of a human aorta;

an access channel configured to provide a path through the sealing body and comprising a side opening; and

a catheter comprising a catheter shaft having a proximal end and a distal end, a proximal delivery element connected at or near the proximal end and a catheter tip at or near the distal end of the catheter shaft, wherein the catheter extends from the proximal end of the device shaft through the access channel and with the catheter tip extending from the side opening, wherein the proximal delivery element comprises a filler delivery system with a filler reservoir.

20. The medical device of claim 19 wherein the catheter tip is configured to enter a false lumen of the aorta through a lining separating the false lumen and true lumen of the aorta or through an entrance opening between the false lumen and true lumen.

21. The medical device of claim 19 wherein the extendable sealing element is a balloon.

22. The medical device of claim 19 wherein the sealing body of the expandable sealing element comprises a proximal sealing element and a distal sealing element that are configured to isolate a portion of a vessel between the proximal sealing element and the distal sealing element.

23. The medical device of claim 22 wherein the proximal sealing element and the distal sealing element each comprise a balloon connected to a common balloon lumen operably connected to a fluid source configured for the delivery of a fluid to inflate the balloons.

24. The device of claim 19 wherein the filler delivery system comprises a stabilization agent reservoir and wherein the catheter comprises a microcatheter with the tip configured for the directed delivery of a stabilization agent.