Vascular embolism prevention device employing filters

• US 6,485,502 B2
• Filed: 03/12/2001
• Issued: 11/26/2002
• Est. Priority Date: 03/10/2000
• Status: Expired due to Term

• Current Assignee: Don Michael International, LLC, Memory Metal Holland BV.
• Original Assignee: Peter Besselink, T. Anthony Don Michael
• Inventors: Don Michael, T. Anthony, Besselink, Peter
• Primary Examiner(s): Worrell, Danny
• Application Number:
  US09/803,641
• Publication Number:
  US 20010044634A1
• Time in Patent Office: 624 Days
• Field of Search: 606/191, 606/200, 606/159, 606/198, 604/104, 604/105, 604/106, 604/107
• US Class Current: 606/200
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A method and system for preventing embolism and optimizing flow to downstream organs in a blood flow circuit incident to performance of a treatment at a location in a blood vessel, by: introducing a first filter element into the blood vessel downstream of the location so that the first filter element obturates the blood vessel; performing the treatment; introducing a second filter element into the blood vessel upstream of the location so that the second filter element obturates the blood vessel; and, after the step of performing a treatment, bringing the first and second filter elements close to one another, radially collapsing the first and second filter elements and withdrawing the first and second filter elements from the blood vessel.

Claims

1. A system for preventing embolism and microembolism in a vascular system, said system comprising:

an elongated support element;

a first filter element with millipores carried by said support element and radially expandable from a closed condition to an open condition;

a second filter element surrounding said support element and radially expandable from a closed condition to an open condition; and

means coupled to at least one of said filter elements for moving said at least one said filter elements between its respective closed and open conditions independently of movements of the other one of said filter elements between its respective closed and open conditions,

wherein each of said filter elements has a filter surface structured to prevent passage of particles and permit passage of blood.

2. The system of claim 1 wherein each of said filter elements has an outer edge concentric with said support element.

3. The system of claim 2 wherein at least one of said filter elements comprises:

an armature of a resiliently deformable material; and

a sheet of filter material secured to said armature and providing said filter surface.

4. The system of claim 3 wherein said at least one of said filter elements has a generally conical or trumpet shape form with a vertex, said vertex being located adjacent said support element.

9. The system of claim 1 wherein at least one of said filter elements comprises a basket of a resiliently deformable material having pores dimensioned to prevent passage of particles and permit passage of blood.

10. The system of claim 1 wherein:

said device is adapted to be inserted into a blood vessel of a patient;

said elongated support element has a distal end adapted to be inserted into the blood vessel and a proximal end adapted to be located outside the patient when said device is in use;

said first filter element is located in proximity to said distal end of said elongated support element; and

said second filter element is disposed at a location proximal to said first filter element and is movable relative to said support element.

11. The system of claim 10, further comprising a displacement member secured to said second filter element for displacing said second filter element relative to said support element.

12. The system of claim 11 further comprising a sheath surrounding said support element, wherein at least one of said filter elements is movable into said sheath in order to radially contract said at least one of said filter elements into the closed condition.

23. The system of claim 1 further comprising means for monitoring blood pressure in the vascular system.

5. A system for preventing embolism and microembolism in a vascular system, said system comprising:

an elongated support element;

a first filter element with millipores carried by said support element and radially expandable from a closed condition to an open condition; and

a second filter element surrounding said support element and radially expandable from a closed condition to an open condition,

wherein;

each of said filter elements has a filter surface structured to prevent passage of particles and permit passage of blood;

each of said filter elements has an outer edge concentric with said support element;

at least one of said filter elements comprises;

an armature of a resiliently deformable material; and

a sheet of filter material secured to said armature and providing said filter surface; and

the material of said armature is an expandable memory metal and said armature is shaped to be in an unstressed state when said one of said filter elements is in the open condition.

6. The system of claim 5 wherein said armature is formed by shape setting.

7. The system of claim 6 wherein said memory metal is nitinol.

8. The system of claim 5 wherein said support element has two opposed ends and a lumen that extends between said ends, and said system further comprises a pressure sensor in communication with the lumen at one of said ends.

13. A method for preventing embolism and microembolism in a blood flow circuit incident to performance of a treatment at a location in a blood vessel, said method comprising:

introducing a first filter element into the blood vessel downstream of the location so that the first filter element obturates the blood vessel;

performing the treatment;

introducing a second filter element into the blood vessel upstream of the location so that the second filter element obturates the blood vessel; and

after the step of performing a treatment, bringing the first and second filter elements close to one another, radially collapsing the first and second filter elements and withdrawing the first and second filter elements from the blood vessel.

14. The method of claim 13, further comprising applying a suction between the first and second filter elements at least after the step of performing a treatment.

15. A method for performing angioplasty comprising:

aligning a first balloon with an obstruction in a blood vessel, the first balloon being radially outwardly expandable;

interposing a second balloon between the first balloon and the obstruction, the second balloon being annular and radially outwardly expandable;

expanding the first balloon to support the second balloon; and

expanding the second balloon to dilate the obstruction.

16. The method of claim 15 further comprising:

before said expanding steps, aligning a stent with the obstruction; and

wherein said step of expanding the second balloon is carried out to fully expand the stent.

17. The method of claim 16 wherein said step of aligning the stent includes conveying the stent to the vicinity of the obstruction while the stent is initially retained by the second balloon within the region enclosed by the second balloon, and then advancing the stent away from the region enclosed by the second balloon and into alignment with the obstruction.

18. The method of claim 16 further comprising trapping, at a location downstream of the obstruction, debris produced during dilation of the obstruction, and removing the debris from the blood vessel.

19. The method of claim 18 wherein said step of removing is carried out by applying suction upstream of the trapping location.

20. A system for performing angioplasty comprising:

a first balloon movable into alignment with an obstruction in a blood vessel, the first balloon being radially outwardly expandable;

a second balloon movable into a position where the second balloon is interposed between said first balloon and the obstruction, said second balloon being annular and radially outwardly expandable;

means coupled to said first balloon for expanding said first balloon to support the second balloon; and

means coupled to said second balloon for expanding said second balloon to dilate the obstruction.

21. The system of claim 20, further comprising a radially outwardly expandable stent initially retained by the second balloon within the region enclosed by the second balloon and displaceable away from the region enclosed by the second balloon and into alignment with the obstruction.

22. A filter element for use in a blood vessel during angioplasty, said element being made of a flexible, radially compressible, radially expandable material, said element being formed to have a conical configuration when radially expanded and being composed of a plurality of circumferential, curved strips and a plurality of longitudinal struts interconnecting said strips, said strips and struts delimiting filter openings.