Inferior vena cava filter on guidewire

• US 20080234722A1
• Filed: 06/13/2007
• Published: 09/25/2008
• Est. Priority Date: 06/14/2006
• Status: Abandoned Application

• Current Assignee: Medrad Incorporated (Bayer AG)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Bonnette, Michael J., Thor, Eric J., Janse, Daniel T., Scherger, Ernest R.
• Application Number:
  US11/811,974
• Publication Number:
  US 20080234722A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A temporary inferior vena cava filter including a guidewire and a doublet cage filter distally located on the guidewire. The doublet cage filter has a proximal cage filter and a distal cage filter, both of resilient and biased toward their expanded or deployed state. The proximal and distal cage filters may be collapsed by actuation, preferably with a sheath. A method of protecting from pulmonary embolism during treatment of a deep vein thrombosis is disclosed. The doublet cage provides stability when deployed in the inferior vena cava, is readily retrieved and readily manufactured. A method of manufacturing the doublet cage filter assembly is also disclosed and involves a nitinol tube with plural cuts to form struts which are heat treated in an expanded state.

Claims

1. A temporary inferior vena cava filter comprising:

a. a guidewire, the guidewire having a distal end and a proximal end; and

,

b. a two-cage filter distally situated on the guidewire, the two-cage filter including;

(1) a first resilient filter cage, the first resilient filter cage actuatable between a collapsed state and a deployed state, and,

(2) a second resilient filter cage, the second resilient filter cage actuatable between a collapsed state and a deployed state, wherein the second resilient filter cage is situated distal to the first resilient filter cage.

2. The temporary inferior vena cava filter of claim 1, wherein the first resilient filter cage and the second resilient filter cage of the two-cage filter are actuated between the collapsed state and the deployed state by a sheath.

3. The temporary inferior vena cava filter of claim 1, wherein the first resilient filter cage and the second resilient filter cage of the two-cage filter are actuated between the collapsed state and the deployed state by a sheath of polyimide material.

4. The temporary inferior vena cava filter of claim 1, wherein the two-cage filter is a doublet filter cage assembly.

5. The temporary inferior vena cava filter of claim 4, wherein the doublet cage is formed from Nitinol tubing material.

6. The temporary inferior vena cava filter of claim 5, wherein the doublet cages are formed in the nitinol tubing by forming a first plurality of parallel cuts in the nitinol tubing at the desired location for one of the doublet cages and a second plurality of parallel cuts for the other of the doublet cages.

7. The temporary inferior vena cava filter of claim 6, wherein at least one of the plurality of parallel cuts are a plurality of helical cuts.

8. The temporary inferior vena cava filter of claim 6, wherein at least one of the plurality of parallel cuts are a plurality of linear, longitudinal, straight cuts.

9. The temporary inferior vena cava filter of claim 6, wherein the doublet cages are heat set in an expanded deployed state.

10. The temporary inferior vena cava filter of claim 5, wherein the proximal end of the nitinol tubing is fixed to the guidewire.

11. The temporary inferior vena cava filter of claim 2, wherein advancing the sheath forces the two-cage filter to a collapsed state and retracting the sheath allows the two-cage filter to resiliently expand to the expanded state.

12. The temporary inferior vena cava filter of claim 1, wherein the guidewire is about a 0.035 inch outer diameter guidewire.

13. The temporary inferior vena cava filter of claim 11, wherein the sheath is a braided polyimide sheath.

14. The temporary inferior vena cava filter of claim 11, wherein the sheath has an internal diameter of about 0.082 inch.

15. The temporary inferior vena cava filter of claim 1, further comprising a transitional cone between the guidewire and the doublet filter assembly.

16. The temporary inferior vena cava filter of claim 15, wherein the transitional cone is plastic or metal.

17. The temporary inferior vena cava filter of claim 5, wherein the nitinol tube is from about 0.062 inch to about 0.047 inch in outer diameter and from about 0.038 inch to about 0.054 inch in inner diameter.

18. The temporary inferior vena cava filter of claim 17, wherein there are from about eight to about 16 cuts in the pluralities of cuts in the nitinol tube.

19. The temporary inferior vena cava filter of claim 17, wherein the resilient cages have a diameter of about 28 mm.

20. A method of providing temporary protective filtering to protect from pulmonary embolism for a patient being treated for deep vein thrombosis, the method comprising the steps of:

a. providing a guidewire with a doublet cage filter, the doublet cage filter including at least two-cage filters actuatable between an expanded/deployable state and a collapsed/removable state and means for actuating the two-cage filters;

b. inserting the two-cage filters on the guidewire into a vein of the patient and advancing the two-cage filters to a protective location relative to the deep vein thrombosis and then deploying the two-cage filters at the protective location;

c. treating the deep vein thrombosis;

d. retracting the two-cage filters to the collapsed state; and

,

e. withdrawing the two-cage filters in the collapsed state with the attached guidewire.

21. The method of claim 20, further comprising the step of:

f. debulking the two-cage filter prior to retraction.

22. The method of claim 20, wherein the step of advancing to a protective location relative to the deep vein thrombosis includes the step of:

g. passing through the deep vein thrombosis.

23. The method of claim 20, wherein the cage filters are resiliently expanded and wherein the guidewire with doublet cage filter further includes a sheath, which sheath may be advanced to collapse the cage filters or retracted to deploy and expand the cage filters and wherein step of deploying the cage filters includes retracting the sheath.

24. The method of claim 20, wherein the cage filters are resiliently expanded and wherein the guidewire with doublet cage filter further includes a sheath, which sheath may be advanced to collapse the cage filters or retracted to deploy and expand the cage filters and wherein step of retrieving the filters includes advancing the sheath to collapse the cage filters.

25. The method of claim 20, wherein the cage filters are formed of nitinol tubing material.

26. The method of claim 25, wherein the cage filters have from eight to 16 struts.

27. The method of claims 26, wherein at least one of the filter cages has struts that are linear when collapsed.

28. The method of claims 26, wherein at least one of the filter cages has struts that are helical when collapsed.

29. The method of claim 26, wherein the filter cages are about 28 mm in diameter in the expanded state.

30. A method of forming a filter cage assembly for attachment to the distal end of a guidewire, the method comprising the steps of:

a. providing a tube; and

,

b. cutting a plurality of parallel slits in the tube to define a plurality of struts.

31. The method of claim 30, wherein the plurality of cuts are longitudinally oriented.

32. The method of claim 30, wherein the plurality of cuts are helically oriented.

33. The method of claim 30, wherein there are from eight to sixteen cuts in the plurality.

34. The method of claim 30, wherein the tube is nitinol and the cuts define a plurality of struts and the struts are heat treated in an expanded state.

35. The method of claim 34, wherein a heat resistant insert holds the struts in the expanded state during heat treatment.

36. The method of claim 34, further comprising the step of attaching to a guidewire.

37. The method of claim 36, further comprising the step of providing an actuator to force the struts into a retracted/collapsed state.

38. The method of claim 37, wherein the actuator is selected from a sheath or a mandrel.

39. The method of claim 30, wherein the filter cage is one of a plurality of filter cages on the same tube, each of the filter cages originating in a separate plurality of cuts to the tube.