SINGLE ACCESS FLOW-REVERSAL CATHETER DEVICES AND METHODS

• US 20130317409A1
• Filed: 03/14/2013
• Published: 11/28/2013
• Est. Priority Date: 04/16/2012
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Trapp, Benjamin M., Vonesh, Michael J.
• Granted Patent: US 9,084,857 B2
• Time in Patent Office: Days
• US Class Current: 604/6.09
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Embodiments herein include devices and methods directed toward creating reverse flow within a vessel and thereby providing protection against embolic debris. Embodiments comprise a catheter and a plurality of occluders that are expandable and adjustable within a lumen to create low-pressure areas that reroute blood flow and embolic debris therein.

Claims

1. A single-access catheter device comprising:

a first catheter having a proximal and distal opening with a lumen therethrough;

a first occluder located within a distal region of the first catheter;

a second occluder located proximal to the first occluder;

a return port located proximal to the second occluder; and

a conduit connecting the distal opening of the first catheter to return port,

wherein the distance between the first occluder and the second occluder is adjustable and

wherein when the first occluder is expanded in a vessel, blood will flow into the conduit.

2. The device of claim 1, further comprising a second catheter concentric around the first catheter wherein the second occluder is coupled to the second catheter.

3. The device of claim 2, wherein the second catheter is slideably coupled to the first catheter.

4. The device of claim 3, further comprising an introducer sheath wherein the introducer sheath is concentric around the first catheter and the second catheter.

5. The device of claim 4, wherein the introducer sheath is slideably coupled to the first catheter and the second catheter.

6. The device of claim 5 wherein the return port comprises an opening along the sidewall of the introducer sheath.

7. The device of claim 5, wherein the return port comprises a distal opening of the introducer sheath.

8. The device of claim 7, further comprising a third occluder coupled to an elongate member, wherein the distance between the third occluder and the first occluder is adjustable.

9. The device of claim 7, further comprising a third occluder and a strut projecting from the distal end of the catheter, wherein the third occluder is coupled to distal portion of strut and is expandable and collapsible.

10. The device of claim 8, further comprising a filter inline of the conduit or about the return port.

11. The device of claim 10, wherein the filter is removable.

12. The device of claim 11, wherein the conduit comprises additional tubing and wherein the filter comprises a mesh basket inline of the additional tubing.

13. The device of claim 12, further comprising an external pump fluidly connected to the conduit.

14. The device of claim 13, wherein an external pump comprises an aspirator.

15. A method for providing embolic protection comprising the steps of providing a single access catheter device comprising:

a catheter having a proximal and distal region with a lumen therethrough;

a first occluder located within the distal region of the catheter;

a second occluder located proximal to the first occluder;

a return port located proximal to the second occluder; and

a conduit connecting the distal end of catheter to return port;

locating a first occluder in a vessel proximate to a treatment site;

locating a second occluder in an aorta downstream of a renal artery;

expanding the first occluder and the second occluder whereby blood flows through the conduit from a distal end of the catheter to the return port.

16. The method of claim 15, wherein the conduit comprises the lumen of the catheter and the interstitial space between an introducer sheath and the catheter.

17. The method of claim 16, further comprising the step of filtering the blood flowing through the conduit to remove at least a portion of embolic debris therein.

18. The method of claim 15, wherein the vessel is a cerebral vessel.

19. The method of claim 18, further comprising the step of expanding a third occluder distal to the first occluder to occlude a branch vessel.

20. The method of claim 19, wherein the branch vessel is the external carotid artery.

21. The method of claim 20, further comprising the step of delivering a medical device through the lumen to the treatment site.

22. The method of claim 21, wherein the medical device comprises a stent.

23. A single-access catheter device comprising:

a first catheter having a proximal and distal region with a lumen therethrough;

a first occluder located within the distal region of the first catheter;

a second occluder located proximal to the first occluder;

a return port located proximal to the second occluder; and

a conduit connecting the distal end of the first catheter to return port, and

an introducer sheath having a lumen through which the first catheter passes through,

wherein when the first occluder is expanded in a vessel, blood will flow into the conduit; and

wherein the conduit comprises at least a portion of the interstitial space between the introducer sheath and the first catheter.

24. The device of claim 23, further comprising a second catheter concentric around the first catheter wherein the second occluder is coupled to the second catheter.

25. The device of claim 24, wherein the second catheter is slideably coupled to the first catheter.

26. The device of claim 25, wherein the introducer sheath is concentric around the first catheter and the second catheter.

27. The device of claim 26, wherein the introducer sheath is slideably coupled to the first catheter and the second catheter.

28. The device of claim 27, wherein the return port comprises an opening along the sidewall of the introducer sheath.

29. The device of claim 27, wherein the return port comprises a distal opening of the introducer sheath.

30. The device of claim 29, further comprising a third occluder coupled to an elongate member, wherein the distance between the third occluder and the first occluder is adjustable.

31. The device of claim 29, further comprising a third occluder and a strut projecting from the distal end of the catheter, wherein the third occluder is coupled to distal portion of strut and is expandable and collapsible.

32. The device of claim 30, further comprising a filter inline of the conduit or about the return port.

33. The device of claim 32, wherein the filter is removable.

34. The device of claim 33, wherein the filter comprises a mesh basket inline of the conduit.

35. The device of claim 34, further comprising an external pump fluidly connected to the conduit.

36. The device of claim 35, wherein an external pump comprises an aspirator.

37. A single-access catheter device comprising:

a first catheter having a proximal and distal region with a lumen therethrough;

a first occluder located within the distal region of the first catheter;

an introducer sheath having a proximal and distal region with a lumen through which the first catheter passes;

a second occluder located on the introducer sheath and located proximal to the first occluder;

a return port located proximal to the second occluder; and

a conduit connecting the distal end of the first catheter to return port.

38. The device of claim 37, wherein the return port further comprises an opening in the wall of the introducer sheath.

39. A single-access catheter device comprising:

a first catheter having a proximal and distal region with a lumen therethrough;

a first occluder located within the distal region of the first catheter;

a second occluder located within proximal of the first occluder;

a return port located proximal to the second occluder; and

a conduit connecting the distal end of first catheter to return port,

wherein the return port comprises an opening located in a wall of the first catheter.

40. The device of claim 39, further comprising an introducer sheath, wherein the return port further comprises an opening in the wall of the introducer sheath.

41. A single-access catheter device comprising:

a first catheter having a proximal and distal region with a lumen therethrough;

a first occluder located within the distal region of the first catheter;

a second occluder located within the proximal region of the first catheter;

a return port located proximal to the second occluder; and

a conduit connecting the distal end of catheter to return port,

wherein the second occluder is located on the first catheter.

42. The device of claim 41, wherein a position of the second occluder on the first catheter is adjustable.