AORTIC ARCH FILTRATION SYSTEM FOR CAROTID ARTERY PROTECTION

• US 20130184742A1
• Filed: 01/16/2013
• Published: 07/18/2013
• Est. Priority Date: 01/17/2012
• Status: Active Grant

• Current Assignee: Lumen Biomedical, Inc.
• Original Assignee: Lumen Biomedical, Inc.
• Inventors: Ganesan, Kavitha, Ogle, Matthew F.
• Granted Patent: US 9,795,470 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/012 Multiple filtering units
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Filtration systems with integrated filter element(s) forming portions of the wall of the filtration catheter are disclosed. The filtration catheters disclosed herein are designed to be used alone or in conjunction with another filter device to provide embolic protection of both carotid arteries. Occlusive element such as balloon is placed on the exterior of the filtration catheter to redirect blood flow in the vessels during the filtration process as well as to help anchor the filtration catheter inside the vessel. The integrated filter element(s) does not require collapsing thus significantly reduces the complexity of the filtration system retrieval process and the chances of releasing emboli back into the blood stream. The compact design of the filtration systems makes them particularly suitable for embolic protection during endovascular procedures on or close to the heart.

Claims

1. A biocompatible filtration catheter comprising:

a shaft having a proximal end and a distal end with a distal opening;

an integrated filter element integrated as part of a wall of the catheter at or near the distal end of the shaft, wherein the integrated filter element provides for fluid flow out from the catheter interior;

a distal section extending in a distal orientation from the integrated filter element;

an occlusive element associated with the exterior of the distal section at or near the distal end of the catheter that can extend radially outward from the exterior of and around the circumference of the shaft; and

a conduit extending within the shaft from the distal end through at least the distal section to the integrated filter element to provide fluid communication between the distal opening and the integrated filter element.

2. The filtration catheter of claim 1 wherein the integrated filter element comprises interwoven fibers.

3. The filtration catheter of claim 2 wherein the interwoven fibers further comprises metal filaments.

4. The filtration catheter of claim 2 wherein the interwoven fibers further comprises surface capillary fibers.

5. The filtration catheter of claim 1 wherein the integrated filter element having a length from about 10 mm to about 70 mm.

6. The filtration catheter of claim 1 wherein the integrated filter element has pore sizes of about 50 micron to about 500 micron.

7. The filtration catheter of claim 1 wherein the integrated filter element comprises approximately the same outer diameter as the shaft.

8. The filtration catheter of claim 1 wherein the occlusive element is a balloon, which has an extended configuration with a diameter suitable to occlude a human brachiocephalic artery.

9. The filtration catheter of claim 8 wherein the balloon comprises a compliant deformable material connected to the shaft to provide for inflation of the balloon.

10. The filtration catheter of claim 8 wherein the shaft comprises a balloon lumen providing fluid communication between a proximal port and the interior of the balloon.

11. The filtration catheter of claim 1 wherein the catheter has a diameter between about 5 Fr to about 7 Fr.

12. The filtration catheter of claim 1 further comprising a sheath slidably positioned over the catheter having a configuration extended in a distal direction relative to the catheter covering the integrated filter element.

13. A filtration system comprising:

the filtration catheter of claim 1; and

a filter device comprising a guide structure and an independent filter element supported by the guide structure,

wherein the filtration catheter comprises a central lumen that is suitable for the delivery of the independent filter element mounted on the guide structure through the distal opening of the shaft.

14. The filtration system of claim 13 wherein the independent filter element comprises surface capillary fibers having a first configuration in a bundle with a low profile and an extended configuration with the centers of the fibers flaring outward from the guide structure, wherein the guide structure comprises a corewire and an overtube with the corewire extending through a lumen of the overtube, and wherein the relative movement of the corewire and the overtube transitions the fibers from the low profile configuration to the extended configuration.

15. The filtration system of claim 13 wherein the independent filter element comprises a filter basket.

16. The filtration system of claim 15 wherein the filter basket comprises an opening into the filter basket oriented toward the proximal end of the guide structure.

17. The filtration system of claim 13 further comprising an aspiration catheter with dimension providing for placement over the guide structure and delivery through the lumen of the filtration catheter.

18. A method for providing embolic protection during an endovascular procedure on or near a patient'"'"'s heart using a filtration system comprising a filtration catheter that comprises a shaft with an inflow opening and a flow conduit, a first integrated filter element replacing a portion of the shaft and an occlusive element distal to the integrated filter element and proximal to the inflow opening with the flow conduit extending from the inflow opening to the integrated filter element, the method comprising,

delivering the filtration catheter through the right subclavian artery to position the occlusive element in the brachiocephalic artery, and

deploying the occlusive element to redirect blood to enter the inflow opening, flow through the flow conduit, and exit as filtered flow through the first integrated filter element into the brachiocephalic artery, bypassing the occlusive element.

19. The method of claim 18 wherein the filtration catheter comprises a second integrated filter element and a second occlusive element distal to the first integrated filter element and proximal to the second integrated filter element with a distal flow conduit providing fluid communication between the inflow opening and the second integrated filter element past the second occlusive element, and wherein delivery of the catheter positions the second occlusive element within the left carotid artery, and further comprising

deploying the second occlusive element to redirect blood to enter the inflow opening, flow through the conduit, and exit as filtered flow through the second integrated filter element into the left carotid artery, bypassing the second occlusive element.

20. The method of claim 19 wherein the occlusive elements are balloons and deployment of the occlusive elements comprises inflating the balloons.

21. The method claim 18 further comprising delivering a filter device with an independent filter element through a lumen of the filtration catheter into the left carotid artery, and

deploying the independent filter element to filter blood flowing into the left carotid artery.

22. The method of claim 18 wherein the flow rate of filtered blood flow into the right carotid artery is at least about 50% of the natural blood flow.

23. The method of claim 18 wherein the positioning of occlusive element is assisted with x-ray visualization.

24. The method of claim 18 further comprising applying aspiration to the integrated filter element through a main lumen of the filtration catheter to remove the emboli trapped inside the integrated filter element.

25. The method of claim 18 further comprising collapsing the occlusive element followed by removing the filtration catheter from the patient.

26. The method of claim 18 further comprising performing an endovascular procedure on the heart, delivering a heart valve delivery catheter through the descending aorta or the subclavian artery to the heart to effect at least a step related to removal of a heart valve or the placement of a prosthetic heart valve, or performing a surgical procedure on the heart while the filtration system is filtering flow into the carotid arteries.

27. The method of claim 26 wherein the procedure comprises replacement of the aortic valve.

28. A biocompatible filtration catheter comprising:

a proximal section;

a proximal filter element integrated as part of a wall of the catheter at or near the distal end of the proximal section;

a bridge section extending in a distal direction relative to the proximal filter and comprising a proximal conduit, a distal conduit and an inflow opening between the proximal conduit and the distal conduit;

a distal filter element integrated as part of the wall of the catheter at or near the distal end of the distal conduit;

a distal section extending in a distal orientation from the distal filter element,

wherein the inflow opening is between the distal filter element and the proximal filter element, the proximal conduit provides fluid communication between the proximal filter element and the inflow opening and the distal conduit provides fluid communication between the distal filter element and the inflow opening;

a proximal occlusive element associated with the exterior of the proximal conduit between the proximal filter element and the inflow opening; and

a distal occlusive element associated with the exterior of the distal conduit between the distal filter element and the inflow opening,

wherein the occlusive elements can extend radially outward from the exterior of the conduits around the circumference of the catheter and

wherein the filter elements provide fluid communication between the inflow opening and the exterior of the catheter through the conduits.

29. The filtration catheter of claim 28 further comprising a distal guide port at or near the distal end of the distal section.

30. The filtration catheter of claim 28 wherein the distal section comprises a closed tubing section.

31. The filtration catheter of claim 28 wherein the catheter has a diameter between about 5 Fr to about 7 Fr.

32. The filtration catheter of claim 28 wherein the filter elements comprises approximately the same diameter as the catheter.

33. The filtration catheter of claim 28 wherein the occlusive elements are compliant balloons.

34. The filtration catheter of claim 33 further comprising at least one balloon lumen inside the catheter to inflate the balloons.

35. The filtration catheter of claim 28 wherein the filter elements comprises interwoven fibers.

36. The filtration catheter of claim 35 wherein the interwoven fibers further comprises metal filaments.

37. The filtration catheter of claim 35 wherein the interwoven fibers further comprises surface capillary fibers.

38. The filtration catheter of claim 28 wherein the proximal filter element having a length of from about 10 mm to about 80 mm while the distal filter element having a length from about 5 mm to about 30 mm.

39. The filtration catheter of claim 28 wherein the filter elements have pore sizes of about 50 micron to about 500 micron.

40. The filtration catheter of claim 28 wherein the distance between the occlusive elements is about 30 mm to about 120 mm.

41. The filtration catheter of claim 28 further comprising a sheath slidably positioned over the catheter having a configuration extended in a distal direction relative to the catheter covering occlusive elements in an unextended configuration.

42. A biocompatible filtration catheter comprising:

a proximal section;

a proximal filter element;

a bridge section extending in a distal direction relative to the proximal section and comprising a proximal conduit, a distal conduit and an inflow opening;

a distal filter element;

a distal section extending in a distal orientation relative to the distal filter element and comprising a guide port at the distal end,

wherein the inflow opening is between the distal filter element and the proximal filter element, the proximal conduit provides fluid communication between the proximal filter element and the inflow opening, and the distal conduit provides fluid communication between the distal filter element and the inflow opening;

a proximal occlusive element associated with the exterior of the proximal conduit, and

a distal occlusive element associated with the exterior of the distal conduit,

wherein the occlusive elements can extend radially outward from the exterior of the conduit around the circumference of the catheter, and

wherein the conduits provide fluid communication between the inflow opening and the exterior of the catheter through the filter elements.

43. A method for restricting emboli from entering the carotid arteries in a patient using a filtration catheter that comprises a proximal section, a distal filter element, a proximal filter element at or near the distal end of the proximal section, a bridge section connecting the proximal filter element and the distal filter element and comprising a proximal conduit and a distal conduit, and an inflow opening between the distal filter element and the proximal filter element, wherein the proximal conduit allows fluid communication between the proximal filter element and the inflow opening and the distal conduit allows fluid communication between the distal filter element and the inflow opening, a proximal occlusive element associated with the exterior of the proximal conduit between the proximal filter element and the inflow opening and a distal occlusive element associated with the exterior of the distal conduit between the distal filter element and the inflow opening, the method comprising:

delivering a guidewire from the right subclavian artery, through the brachiocephalic artery, along the aortic arch to the left carotid artery;

tracking the filtration catheter over the guidewire to position the distal occlusive element inside the left carotid artery, the proximal occlusive element inside the brachiocephalic artery, and the inflow opening inside the aortic arch; and

expanding the proximal occlusive element and the distal occlusive element to make sealing engagements with the walls of the brachiocephalic artery and the left carotid artery respectively to inhibit direct blood flow from entering into respective arteries while redirecting the blood flow to enter the inflow opening, to flow through the conduits and then to exit the filter elements to provide filtered blood flow into the left carotid artery and the right carotid artery from the aorta, wherein the flow rate of filtered blood flow is at least about 50% of the natural blood flow in respective arteries.

44. The method of claim 43 wherein the flow rate of filtered blood flow is at least about 70% of the natural blood flow in respective arteries.

45. The method of claim 43 wherein the positioning of occlusive elements are assisted with x-ray visualization.

46. The method of claim 43 further comprising applying aspiration to the filter elements through a main lumen of the filtration catheter to remove the emboli trapped inside the filter elements.

47. The method of claim 43 further comprising collapsing the occlusive elements followed by removing the filtration catheter from the patient.