Apparatus and method for thromboembolic protection

• US 20030158516A1
• Filed: 12/26/2002
• Published: 08/21/2003
• Est. Priority Date: 12/27/2001
• Status: Active Grant

• Current Assignee: Mark H. Wholey, Michael Wholey
• Original Assignee: Mark H. Wholey, Michael Wholey
• Inventors: Wholey, Mark H., Wholey, Michael
• Granted Patent: US 7,322,958 B2
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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: A61F 2230/0006 circular
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes

Abstract

A catheter apparatus captures thromboembolic material in the arterial and venous circulation. The apparatus includes an inner hollow tube and an outer hollow tube in sliding engagement with the inner hollow tube. A radially expandable segment, such as an inflatable balloon, is attached near the distal end of the catheter. One end portion of the balloon is attached to the inner tube and the other end portion is attached to the outer tube. When the catheter is advanced through a vessel to be treated, the balloon is deflated and the outer tube is slidably advanced to a storage position so that the balloon compactly surrounds the catheter. When the catheter is in place within the vessel, the outer tube is slidably advanced to a treatment position and the balloon is inflated. As the vessel is treated, the inflated balloon captures and contains thromboembolic particles that may be released, and the particles are suctioned out of the patient through apertures located in the outer hollow tube proximal to the balloon.

Claims

1. An apparatus for capturing and retrieving embolic material from a blood vessel, the apparatus comprising:

a first hollow tube having a proximal end and a distal end, wherein the distal end is insertable into the vessel;

a second hollow tube coaxially and slidably positioned over the first hollow tube, wherein a wall of the second hollow tube includes a plurality of apertures structured and configured for retrieving the embolic material; and

a radially expandable segment expandable from a deflated position to an inflated position in contact with an inner wall of the blood vessel structured and configured for capturing the embolic material to be retrieved, wherein a proximal portion of the radially expandable segment is attached to the second hollow tube, and a distal portion of the radially expandable segment is attached adjacent the distal end of the first hollow tube.

2. The apparatus of claim 1, wherein the second hollow tube is structured to be coaxially advanced toward the proximal end of the first hollow tube to a storage position when the radially expandable segment is in the deflated position.

3. The apparatus of claim 2, wherein the radially expandable segment is structured to compactly surround at least a portion of the first hollow tube and at least a portion of the second hollow tube when the second hollow tube is in the storage position.

4. The apparatus of claim 3, further comprising means for maintaining tension on the radially expandable segment when the second hollow tube is in the storage position.

5. The apparatus of claim 4, wherein the radially expandable segment is elongated when the tension is maintained thereon.

6. The apparatus of claim 4, wherein the tension is maintained on the radially expandable segment by a seal mounted between the first and second hollow tubes which provides frictional resistance to relative movement of the first and second hollow tubes.

7. The apparatus of claim 2, wherein the diameter of the radially expandable segment is from about 0.8 mm to about 3 mm when the radially expandable segment is in the deflated position and the second hollow tube is in the storage position.

8. The apparatus of claim 2, wherein the diameter of the radially expandable segment is from about 0.85 mm to about 1.4 mm when the radially expandable segment is in the deflated position and the second hollow tube is in the storage position.

9. The apparatus of claim 2, wherein the length of the radially expandable segment is from about 0.25 cm to about 8 cm when the radially expandable segment is in the deflated position and the second hollow tube is in the storage position.

10. The apparatus of claim 2, wherein the length of the radially expandable segment is from about 1 cm to about 4 cm when the radially expandable segment is in the deflated position and the second hollow tube is in the storage position.

11. The apparatus of claim 1, wherein the second hollow tube is structured to be coaxially advanced towards the distal end of the first hollow tube to a treatment position when the radially expandable segment is in an inflated position.

12. The apparatus of claim 11, wherein the diameter of the radially expandable segment is from about 2 mm to about 30 mm when the radially expandable segment is in the inflated position and the second hollow tube is in the treatment position.

13. The apparatus of claim 11, wherein the diameter of the radially expandable segment is from about 3 mm to about 11 mm when the radially expandable segment is in the inflated position and the second hollow tube is in the treatment position.

14. The apparatus of claim 11, wherein the ratio of the diameter of the radially expandable segment in the inflated position when the second hollow tube is in the treatment position to the diameter of the radially expandable segment in a deflated position when the second hollow tube is in a storage position is from about 2.5:

1 to about 10;

1.

15. The apparatus of claim 11, wherein the ratio of the diameter of the radially expandable segment in the inflated position when the second hollow tube is in the treatment position to the diameter of the radially expandable segment in a deflated position when the second hollow tube is in a storage position is from about 3.5:

1 to about 8;

1.

16. The apparatus of claim 11, wherein the length of the radially expandable segment is from about 0.25 cm to about 4 cm when the radially expandable segment is in the inflated position and the second hollow tube is in the treatment position.

17. The apparatus of claim 11, wherein the length of the radially expandable segment is from about 0.5 cm to about 2 cm when the radially expandable segment is in the inflated position and the second hollow tube is in the treatment position.

18. The apparatus of claim 1, wherein a wall of the first hollow tube comprises a plurality of apertures inside the radially expandable segment.

19. The apparatus of claim 1, wherein the distal end of the first hollow tube comprises a flexible material.

20. The apparatus of claim 19, wherein the distal portion of the radially expandable segment is attached to the flexible material.

21. The apparatus of claim 1, wherein the second hollow tube comprises a guidewire.

22. The apparatus of claim 21, wherein the guidewire comprises coiled wire.

23. The apparatus of claim 1, wherein the second hollow tube is structured and arranged to receive a treatment device for treating the blood vessel.

24. The apparatus of claim 1, further comprising a hub at the proximal end of the apparatus in communication with the first hollow tube and the second hollow tube.

25. The apparatus of claim 24, wherein the hub is removeably attached to the first hollow tube and the second hollow tube.

26. An apparatus for capturing and retrieving embolic material from a blood vessel, the apparatus comprising:

a first hollow tube having a proximal end and a distal end, wherein the distal end is insertable into the vessel;

a second hollow tube coaxially positioned over the first hollow tube, wherein a wall of the second hollow tube includes a plurality of apertures structured and configured for retrieving the embolic material;

a radially expandable segment attached to the first hollow tube and the second hollow tube and structured and configured for capturing the embolic material to be retrieved; and

means for compactly surrounding at least a portion of the first hollow tube and at least a portion of the second hollow tube with the radially expandable segment.

27. A method for capturing and retrieving embolic material from a blood vessel, the method comprising the steps of:

inserting a catheter into the blood vessel, wherein the catheter comprises;

a first hollow tube having a proximal end and a distal end;

a second hollow tube coaxially and slidably positioned over the first hollow tube and advanced towards the proximal end of the first hollow tube in a storage position, wherein a wall of the second hollow tube includes a plurality of apertures structured and configured for retrieving the embolic material; and

a radially expandable segment, wherein a proximal portion of the radially expandable segment is attached to the second hollow tube and a distal portion of the radially expandable segment is attached adjacent the distal end of the first hollow tube;

guiding the radially expandable segment past a portion of the blood vessel to be treated;

sliding the second hollow tube towards the distal end of the first hollow tube to a treatment position;

inflating the radially expandable segment;

treating the blood vessel;

deflating the radially expandable segment and sliding the second hollow tube towards the proximal end of the first hollow tube to the storage position; and

removing the catheter from the blood vessel.

28. The method of claim 27, further comprising the steps of:

capturing embolic material with the inflated radially expandable segment; and

suctioning the captured embolic material through the apertures of the second hollow tube to a location outside of the blood vessel.

29. The method of claim 27, wherein the second hollow tube is structured and arranged to receive a treatment device for treating the blood vessel.

30. A method of capturing and retrieving embolic material from a blood vessel, the method comprising the steps of:

inserting a catheter into the blood vessel, wherein the catheter comprises;

a first hollow tube having a proximal end and a distal end;

a second hollow tube coaxially and slidably positioned over the first hollow tube and advanced towards the proximal end of the first hollow tube in a storage position, wherein a wall of the second hollow tube includes a plurality of apertures structured and configured for retrieving the embolic material; and

a radially expandable segment, wherein a proximal portion of the radially expandable segment is attached to the second hollow tube and a distal portion of the radially expandable segment is attached adjacent the distal end of the first hollow tube;

guiding the radially expandable segment past a portion of the blood vessel to be treated;

sliding the second hollow tube towards the proximal end of the first hollow tube to a treatment position;

inflating the radially expandable segment;

treating the blood vessel by advancing the catheter in a proximal direction, wherein the inflated radially expandable segment passes through the portion of the blood vessel to be treated, thereby capturing embolic material;

removing the captured embolic material through the apertures of the second hollow tube to a location outside of the blood vessel;

deflating the radially expandable segment; and

removing the catheter from the blood vessel.

31. The method of claim 30, wherein the inflated radially expandable segment removes embolic material from a wall of the blood vessel as it passes through the portion of the blood vessel to be treated.

32. The method of claim 30, wherein the second hollow tube is structured and arranged to receive a treatment device for treating the blood vessel.