Retrievable inferior vena cava filter system and method for use thereof

• US 5,893,869 A
• Filed: 02/19/1997
• Issued: 04/13/1999
• Est. Priority Date: 02/19/1997
• Status: Expired due to Fees

• Current Assignee: Iowa State University Research Foundation Incorporated (Iowa State University)
• Original Assignee: University of Iowa Research Foundation
• Inventors: Lang, Elvira V., Barnhart, William H.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US08/802,061
• Time in Patent Office: 783 Days
• Field of Search: 606/198, 606/200, 604/174, 604/264, 604/280
• US Class Current: 606/200
• 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: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A percutaneous filter system for providing temporary filtering of emboli from the blood is disclosed, the filter system including a delivery catheter having a first working access lumen and a second filter deployment/retrieval lumen containing a filtering device which is deployable therefrom. The filtering device includes a deployment/retrieval wire section and a filtering element formed at the distal end of said deployment/retrieval wire section. The filtering element is made of shape memory/superelastic material and is formed to have a distally expanding frustoconical pre-disposed shape which, when the filtering element is deployed by being extended distally from the delivery catheter through the filter deployment/retrieval lumen thereof, defines a filtering channel that is offset from said deployment/retrieval axis and extends about the extended axis of the working access lumen of the delivery catheter. When the filtering element is so deployed within a blood vessel, emboli trapped within the filtering element are funneled toward working access lumen of the delivery catheter and can easily be aspirated or otherwise removed therethrough. With the filtering element in place in its deployed position, other instrumentation may also be passed through the working access lumen of the delivery catheter and the filtering channel to gain access into the blood vessel as desired.

Claims

1. A filtering system for filtering emboli from blood within a blood vessel, said filtering system comprising:

a delivery catheter having a first working access lumen defining a working access axis, and a second filter deployment/retrieval lumen defining a filter deployment/retrieval axis; and

a filtering device receivable within said filter deployment/retrieval lumen, said filtering device including a deployment/retrieval wire section and a filtering element formed at the distal end of said deployment/retrieval wire section, said filtering element being made of shape memory/superelastic material and being formed to have a pre-disposed shape which, when said filtering element has been deployed by being extended distally from said delivery catheter through said filter deployment/retrieval lumen thereof, defines a filtering channel that is offset from said deployment/retrieval axis and which extends about the extended axis of the working access lumen of the delivery catheter, whereby when said filtering element is so deployed within a blood vessel, emboli trapped within the filtering element are funneled toward the working access lumen of said delivery catheter for removal therethrough.

2. The filtering system for filtering emboli from blood within a blood vessel of claim 1 wherein the filtering channel defined by said filtering element is at least as large as the diameter of said working access lumen of said delivery catheter.

3. The filtering system for filtering emboli from blood within a blood vessel of claim 1 wherein said filtering element is generally expanding in the distal direction away from said delivery catheter.

4. The filtering system for filtering emboli from blood within a blood vessel of claim 1 wherein said filtering element forms a generally frustoconical shape.

5. The filtering system for filtering emboli from blood within a blood vessel of claim 1 wherein the filter axis is offset from said deployment/retrieval wire an amount approximately equal to the distance between the axes of the filter deployment/retrieval lumen and the working access lumen at the distal end of said catheter.

6. The filtering system for filtering emboli from blood within a blood vessel of claim 1 wherein the diameter of the working access lumen is substantially larger than the diameter of the filter deployment/retrieval lumen.

7. The filtering system for filtering emboli from blood within a blood vessel of claim 1 wherein said filtering element includes a series of turns and wherein each turn successively increases in diameter from the most proximal to the most distal of said turns.

8. The filtering system for filtering emboli from blood within a blood vessel of claim 7 wherein there are a total of between 4 to 8 of said turns.

9. The filtering system for filtering emboli from blood within a blood vessel of claim 8 wherein the diameter of the most distal of said turns is greater than the inner diameter of the blood vessel.

10. The filtering device for filtering emboli from blood within a blood vessel of claim 1 wherein the shape memory/superelastic alloy from which said filtering element is made is in its superelastic temperature range at blood temperature.

11. The filtering system for filtering emboli from blood within a blood vessel of claim 10 wherein said filtering device is an integrally formed, one-piece wire made of Nitinol.

12. The filtering system for filtering emboli from blood within a blood vessel of claim 1 wherein the filter deployment/retrieval lumen is enlarged at the distal end of said catheter.

13. The filtering system for filtering emboli from blood within a blood vessel of claim 1 wherein said catheter has an outer surface that is tapered at the distal end of said catheter.

14. A method for filtering emboli from blood within a blood vessel, said method comprising the steps of:

introducing a delivery catheter into the blood vessel, the delivery catheter having a first working access lumen defining a working access axis, and a second filter deployment/retrieval lumen defining a filter deployment/retrieval axis, and a filtering device received within the filter deployment/retrieval lumen, the filtering device including a deployment/retrieval wire section and a filtering element formed at the distal end of the deployment/retrieval wire section, the filtering element being made of shape memory/superelastic material and being formed to have a pre-disposed shape which, when the filtering element has been deployed by being extended distally from the delivery catheter through the filter deployment/retrieval lumen thereof, defines a filtering channel that is offset from the deployment/retrieval axis and which extends about the extended axis of the working access lumen of the delivery catheter;

advancing the distal end of the delivery catheter to a desired location within the blood vessel; and

advancing the filtering device relative to the delivery catheter so that the filtering element exits the filter deployment/retrieval lumen at the distal end of the catheter and expands into its pre-disposed shape within the blood vessel, whereby emboli trapped within the filtering element are funneled toward the working access lumen of the delivery catheter for removal therethrough.

15. The method for filtering emboli from blood within a blood vessel of claim 14 in which the filtering channel defined by said filtering element is at least as large as the diameter of the working access lumen of the delivery catheter.

16. The method for filtering emboli from blood within a blood vessel of claim 14 in which the filtering element is generally expanding in the distal direction away from the delivery catheter.

17. The method for filtering emboli from blood within a blood vessel of claim 14 in which the filtering element forms a generally frustoconical shape.

18. The method for filtering emboli from blood within a blood vessel of claim 14 further includes the step of applying suction to the desired location through the working access lumen.

19. The method for filtering emboli from blood within a blood vessel of claim 18 wherein said applying suction step includes advancing a catheter having proximal and distal ends through the working access lumen, said catheter having a suction source connected at its proximal end.

20. The method for filtering emboli from blood within a blood vessel of claim 14 which additionally includes the step of passing another instrument through the working access lumen of the delivery catheter and the filtering channel to gain access into the blood vessel.

21. The method for filtering emboli from blood within a blood vessel of claim 14 in which the shape memory/superelastic alloy from which the filtering element is made is in its superelastic temperature range at blood temperature.