Apparatus and methods for stent delivery with embolic protection

• US 8,814,925 B2
• Filed: 03/20/2008
• Issued: 08/26/2014
• Est. Priority Date: 03/20/2007
• Status: Active Grant

• Current Assignee: Envision Scientific Pvt Ltd.
• Original Assignee: Minvasys
• Inventors: Hilaire, Pierre, Van De Leest, Machiel
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US12/532,141
• Publication Number:
  US 20100087908A1
• Time in Patent Office: 2,350 Days
• Field of Search: 606/191, 606/192, 606/194, 606/195, 606/198, 606/200, 623/1.11, 623/1.13, 623/1.15, 623/1.32, 623/1.39, 623/1.4, 623/1.44
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• 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 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A catheter system including: a stent delivery catheter (2) having a proximal end and a distal end and an interior lumen extending between the proximal end and the distal end; a stent (1) having a proximal end and a distal end and a stent lumen extending between the proximal end and the distal end, the stent having an expanded state and an unexpanded state; and an embolic protection filter (3) having an expanded state and an unexpanded state; the catheter system having a deployed position and an undeployed position. When the catheter system is in the undeployed position, the stent (1) is in its unexpanded state and positioned within the interior lumen of the stent delivery catheter (2) and the embolic protection filter (3) is in its unexpanded state and positioned within the stent lumen of the stent.

Claims

1. A catheter system, comprising:

a stent delivery catheter having a proximal end and a distal end and an interior lumen extending between the proximal end and the distal end;

a stent having a proximal end and a distal end and a stent lumen extending between the proximal end and the distal end, the stent having an expanded state and an unexpanded state;

and an embolic protection filter having an expanded state and an unexpanded state;

the catheter system having a deployed position and an undeployed position,

a guidewire having a guidewire shaft, wherein the embolic protection filter is slidably mounted on the guidewire shaft;

wherein the embolic protection filter comprises;

a filter member connected to a distal filter cylinder having an inner diameter D₁ larger than an outer diameter d₂ of the guidewire shaft;

a plurality of connecting wires having a first end connected to an outer periphery of the filter member and a second end connected to a proximal filter cylinder having an inner diameter D₂ larger than the outer diameter d₂ of the guidewire shaft;

and an actuation member attached to the guidewire shaft, the actuation member having an outer diameter d₁ that is larger than the outer diameter d₂ of the guidewire shaft and larger than the inner diameter D₂ of the proximal filter cylinder;

wherein, when the catheter system is in the undeployed position, the stent is in its unexpanded state and positioned within the interior lumen of the stent delivery catheter and the embolic protection filter is in its unexpanded state and positioned within the stent lumen of the stent.

2. The catheter system of claim 1, wherein, when the catheter system is in the deployed position, the stent is in its expanded state and positioned exterior to the interior lumen of the stent delivery catheter and the embolic protection filter is in its expanded state and positioned within the stent lumen of the expanded stent.

3. The catheter system of claim 2, further comprising a stent pusher catheter having a catheter shaft with a proximal end and a distal end and sized to fit within the interior lumen of the stent delivery catheter proximal to the stent, wherein the stent pusher catheter is configured to selectively deploy the catheter system by urging the stent from its unexpanded state within the interior lumen of the stent delivery catheter to its expanded state exterior to the interior lumen of the stent delivery catheter.

4. The catheter system of claim 3, further comprising an inflatable angioplasty balloon mounted near the distal end of the catheter shaft of the stent pusher catheter.

5. The catheter system of claim 4, wherein the stent pusher catheter has a shoulder at the distal end of the catheter shaft configured to bear against the proximal end of the stent.

6. The catheter system of claim 1, wherein the stent is a self-expanding stent.

7. The catheter system of claim 1, wherein the actuation member comprises a radiopaque material.

8. The catheter system of claim 1, further comprising a catheter tip member attached to the embolic protection filter, wherein, when the catheter system is in the undeployed position, the catheter tip member is positioned to provide a smooth transition on the distal end of the stent delivery catheter for insertion of the catheter system into a patient.

9. The catheter system of claim 1, further comprising a stent pusher catheter having a catheter shaft with a proximal end and a distal end and sized to fit within the interior lumen of the stent delivery catheter proximal to the stent, wherein the stent pusher catheter is configured to selectively deploy the catheter system by urging the stent from its unexpanded state within the interior lumen of the stent delivery catheter to its expanded state exterior to the interior lumen of the stent delivery catheter.

10. The catheter system of claim 1, further comprising:

a stent pusher catheter having a catheter shaft with a proximal end and a distal end, the catheter shaft sized to fit within the interior lumen of the stent delivery catheter proximal to the stent, a shoulder at the distal end of the catheter shaft configured to bear against the proximal end of the stent,

and an inflatable angioplasty balloon mounted near the distal end of the catheter shaft of the stent pusher catheter,

wherein the stent pusher catheter is configured to selectively deploy the catheter system by urging the stent from its unexpanded state within the interior lumen of the stent delivery catheter to its expanded state exterior to the interior lumen of the stent delivery catheter.

11. A catheter system, comprising:

a stent delivery catheter having a proximal end and a distal end and an interior lumen extending between the proximal end and the distal end;

a stent having a proximal end and a distal end and a stent lumen extending between the proximal end and the distal end, the stent having an expanded state and an unexpanded state;

and an embolic protection filter having an expanded state and an unexpanded state;

the catheter system having a deployed position and an undeployed position,

a guidewire having a guidewire shaft, wherein the embolic protection filter is slidably mounted on the guidewire shaft;

wherein the embolic protection filter comprises;

a filter member connected to a distal filter cylinder having an inner diameter D₁ larger than an outer diameter d₂ of the guidewire shaft;

a plurality of connecting wires having a first end connected to an outer periphery of the filter member and a second end connected to a proximal filter cylinder having an inner diameter D₂ larger than the outer diameter d₂ of the guidewire shaft;

and an actuation member attached to the guidewire shaft, the actuation member having an outer diameter d₁ that is larger than the outer diameter d₂ of the guidewire shaft and larger than the inner diameter D₂ of the proximal filter cylinder;

wherein the inner diameter D₁ of the distal filter cylinder is larger than the outer diameter d₁ of the actuation member.

12. The catheter system of claim 11, wherein the actuation member comprises a radiopaque material.

13. The catheter system of claim 11, further comprising a catheter tip member attached to the embolic protection filter, wherein, when the catheter system is in the undeployed position, the catheter tip member is positioned to provide a smooth transition on the distal end of the stent delivery catheter for insertion of the catheter system into a patient.

14. A catheter system, comprising:

a stent delivery catheter having a proximal end and a distal end and an interior lumen extending between the proximal end and the distal end;

a self-expandable stent having a proximal end and a distal end and a stent lumen extending between the proximal end and the distal end, the stent having an expanded state and an unexpanded state;

and a self-expandable embolic protection filter having an expanded state and an unexpanded state;

a stent pusher catheter having a catheter shaft with a proximal end and a distal end and sized to fit within the interior lumen of the stent delivery catheter proximal to the stent, the stent pusher catheter having a shoulder at the distal end of the catheter shaft configured to bear against the proximal end of the stent, wherein the stent pusher catheter is configured to selectively deploy the catheter system by urging the stent from its unexpanded state within the interior lumen of the stent delivery catheter to its expanded state exterior to the interior lumen of the stent delivery catheter;

an inflatable angioplasty balloon mounted near the distal end of the catheter shaft of the stent pusher catheter;

the catheter system having a deployed position and an undeployed position, wherein, when the catheter system is in the undeployed position, the stent is in its unexpanded state and positioned within the interior lumen of the stent delivery catheter and the embolic protection filter is in its unexpanded state and positioned within the stent lumen of the stent.

15. The catheter system of claim 14, wherein, when the catheter system is in the deployed position, the stent is in its expanded state and positioned exterior to the interior lumen of the stent delivery catheter and the embolic protection filter is in its expanded state and positioned within the stent lumen of the expanded stent.

16. The catheter system of claim 14, further comprising a guidewire having a guidewire shaft, wherein the embolic protection filter is mounted on the guidewire shaft.

17. The catheter system of claim 16, wherein the embolic protection filter is slidably mounted on the guidewire shaft.

18. A method of deploying a stent with embolic protection utilizing the catheter system of claim 14, the method comprising:

introducing the catheter system into a patient;

and deploying the catheter system to the deployed position wherein the stent is in its expanded state and positioned exterior to the interior lumen of the stent delivery catheter and the embolic protection filter is in its expanded state and positioned within the stent lumen of the expanded stent.

19. The method of claim 18, further comprising:

collapsing the embolic protection filter to its unexpanded state and withdrawing the embolic protection filter from the stent lumen of the expanded stent.

20. The method of claim 18, wherein the catheter system is deployed using the stent pusher catheter positioned within the interior lumen of the stent delivery catheter to urge the stent from its unexpanded state within the interior lumen of the stent delivery catheter to its expanded state exterior to the interior lumen of the stent delivery catheter.

21. The method of claim 20, further comprising:

advancing the angioplasty balloon mounted on the stent pusher catheter into the stent lumen of the expanded stent and inflating the angioplasty balloon within the stent lumen.

22. The method of claim 21, further comprising:

deflating the angioplasty balloon and withdrawing the stent pusher catheter from the stent lumen of the expanded stent.

23. The method of claim 18, wherein the catheter system further comprises a guidewire having a guidewire shaft, wherein the embolic protection filter is mounted on the guidewire shaft.

24. The method of claim 23, wherein the embolic protection filter is slidably mounted on the guidewire shaft.

25. The method of claim 24, wherein the embolic protection filter comprises:

a filter mesh connected to a distal filter cylinder having an inner diameter D₁ larger than an outer diameter d₂ of the guidewire shaft;

a plurality of connecting wires having a first end connected to an outer periphery of the filter mesh and a second end connected to a proximal filter cylinder having an inner diameter D₂ larger than the outer diameter d₂ of the guidewire shaft;

and an actuation member attached to the guidewire shaft, the actuation member having an outer diameter d₁ that is larger than the outer diameter d₂ of the guidewire shaft and larger than the inner diameter D₂ of the proximal filter cylinder;

and wherein the method further comprises;

withdrawing the guidewire shaft in a proximal direction with respect to the embolic protection filter such that the actuation member engages the proximal filter cylinder and collapses the embolic protection filter into a lumen of a filter retrieval catheter.

26. The method of claim 25, wherein the catheter system further comprises a catheter tip member attached to the embolic protection filter, wherein, when the catheter system is in the undeployed position, the catheter tip member is positioned to provide a smooth transition on the distal end of the stent delivery catheter for insertion of the catheter system into a patient.

27. The method of claim 18, wherein the catheter system further comprises a catheter tip member attached to the embolic protection filter, wherein, when the catheter system is in the undeployed position, the catheter tip member is positioned to provide a smooth transition on the distal end of the stent delivery catheter for insertion of the catheter system into a patient.