Apparatus for thromboembolic protection

• US 7,322,958 B2
• Filed: 12/26/2002
• Issued: 01/29/2008
• Est. Priority Date: 12/27/2001
• Status: Expired due to Fees

• Current Assignee: Mark H. Wholey, Michael Wholey
• Original Assignee: Mark H. Wholey, Michael Wholey
• Inventors: Wholey, Mark H., Wholey, Michael
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US10/329,585
• Publication Number:
  US 20030158516A1
• Time in Patent Office: 1,860 Days
• Field of Search: 604 9503- 9504, 604/96.01, 604/97.01, 604/98.01, 604/103.05, 604/109, 604/102.01, 604/102.03, 604/103.14, 604/164.13, 604506-510, 604915-920, 604/97.07, 606192-200, 600/585
• US Class Current: 604/102.01
• 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 having inflation apertures, 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 aspiration apertures structured and configured for retrieving the embolic material;

a seal preventing fluid communication between the inflation apertures of the first hollow tube and the aspiration apertures at the distal end of the second hollow tube; 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 at a position distal to the aspiration apertures, and a distal portion of the radially expandable segment is attached to the first hollow tube at a position distal to the inflation apertures.

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 an o-ring 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 aff ached 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 having inflation apertures, 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 aspiration apertures structured and configured for retrieving the embolic material;

a radially expandable segment attached to the first hollow tube at a position distal to the inflation apertures and the second hollow tube at a position distal to the aspiration apertures and structured and configured for capturing the embolic material to be retrieved;

a seal preventing fluid communication between the inflation apertures and the aspiration apertures at the distal end of the second hollow tube; 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.