Low profile emboli capture device

• US 8,236,024 B2
• Filed: 10/28/2004
• Issued: 08/07/2012
• Est. Priority Date: 02/20/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Stanford, Ulf Harry, Chin, Yem, Zhong, Sheng-Ping, Griego, John A
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US10/975,851
• Publication Number:
  US 20050101988A1
• Time in Patent Office: 2,840 Days
• Field of Search: 623/1.11, 606/200
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• 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 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: B29C 53/66 with axially movable winding feed member , e.g. lathe type winding

Abstract

A low profile emboli capture device is provided for use in angioplasty and other intravascular procedures. A standard guidewire is utilized having a reduced cross-sectional area formed near its distal end. A filter and self-expanding stent are packaged on the reduced cross-sectional area of the guidewire. A movable sleeve extends over the guidewire and holds the self-expanding stent and filter in their retracted positions while the device is being positioned in the artery. The sheath is moved relative to the self-expanding stent and filter, whereupon the self-expanding stent and filter become deployed.

Claims

1. A low profile emboli capture device comprising:

a guidewire having a proximal end and a distal end, wherein the guidewire includes a mounting region proximate the distal end, wherein the guidewire has a cross-sectional profile and the mounting region has a cross-sectional profile less than the cross-sectional profile of the guidewire, the filter disposed about at least a portion of the mounting region;

a filter disposed about a distal portion of the guidewire, the filter having a retracted position and an expanded position, the filter being adapted to capture emboli in its expanded position;

a stent attached to the filter; and

a sleeve extending over at least a portion of the filter in the retracted position, the sleeve infolded such as to form an inner layer and an outer layer, wherein the inner layer of the sleeve is secured to the guidewire.

2. The device of claim 1, wherein when the outer layer of the sleeve is moved from the first position to the second position, at least a portion of the inner layer becomes a portion of the outer layer.

3. The device of claim 1, wherein the inner layer of the sleeve is secured to the guidewire at a location proximal the filter.

4. The device of claim 1, wherein the stent is self-expanding.

5. The device of claim 1, wherein the stent floats on at least a portion of the guidewire.

6. The device of claim 1, wherein the filter includes a first emboli collection chamber and a second emboli collection chamber.

7. The device of claim 1, wherein the filter includes a multi-layered mesh comprising a plurality of filaments, each filament having a width that is greater than its height.

8. The device of claim 1, wherein in the retracted position the filter has a cross-sectional profile approximately the same as the cross-sectional profile of the guidewire.

9. The device of claim 1, wherein the sleeve includes a plurality of distal openings for providing lubricants or medications.

10. The device of claim 1, further comprising a handle attached to the sleeve for manipulation of the sleeve.

11. The device of claim 1, wherein the filter includes a filter mesh having a non-thrombogenic coating.

12. The device of claim 1, wherein the filter includes a filter mesh having a hydrogel coating.

13. The device of claim 1, wherein the sleeve includes a longitudinally extending line of weakening.

14. A low profile emboli capture device comprising:

a guidewire having a proximal end, a distal end and a cross-sectional profile, the guidewire including a mounting region having a cross-sectional profile less than the guidewire cross-sectional profile;

a filter disposed about at least a portion of the mounting region, the filter having a retracted position and an expanded position, wherein in the retracted position the filter has a cross-sectional profile approximately the same as the cross-sectional profile of the guidewire;

a stent attached to the filter; and

a sleeve disposed about at least a portion of the guidewire and slidable thereon, the sleeve including an inverted, double folded end portion extending over the filter, wherein the sleeve is movable between a first position for retaining the filter in the retracted position and a second position for releasing the filter in the expanded position, further wherein the inner layer of the sleeve is secured to the guidewire at a location proximal the mounting region.

15. The device of claim 14, wherein the inverted, double folded end portion of the sleeve defines an inner layer, an outer layer and a fold.

16. The device of claim 15, wherein as the sleeve is moved from the first position to the second position, at least a portion of the inner layer becomes a portion of the outer layer.

17. The device of claim 15, wherein a distal end of the sleeve includes the fold.

18. The device of claim 17, wherein when the sleeve is moved from the first position to the second position, the fold moves to allow the filter to expand to the expanded position.

19. The device of claim 15, wherein the inner layer, outer layer and fold are a single continuous member.

20. The device of claim 14, wherein the filter further comprises a self-expanding expansion member disposed about at least a portion of the mounting region.