Embolic protection device

• US 6,695,865 B2
• Filed: 04/29/2002
• Issued: 02/24/2004
• Est. Priority Date: 03/20/2000
• Status: Expired due to Fees

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Bailey, Steven R., Boyle, Christopher T.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/136,246
• Publication Number:
  US 20020165576A1
• Time in Patent Office: 666 Days
• Field of Search: 606/200, 606/114, 606/113, 606/127, 606/159
• US Class Current: 606/200
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: Y10S 977/876 Nanotube tip

Abstract

An embolic protection device includes a catheter body having a central longitudinal lumen, a guidewire positioned within the central longitudinal lumen, and a graft member that is generally tubular in shape in an undeployed state and generally frustroconical in shape in a deployed state. A plurality of openings are formed in the graft member and a plurality of arm members interconnect a proximal end of the graft member with the catheter body. A distal end of the graft member is connected to the guidewire or the atraumatic tip. The graft member may be fabricated of superelastic materials, plastically deformable materials or self-expanding materials and the plurality of openings are capable of diametric expansion and reduction proportionate to the degree of diametric expansion and reduction of a corresponding transverse cross-sectional region of the graft member when in the deployed state to capture emboli or particulate matter and minimize extrusion of the captured material through the openings in the graft member when the graft member is collapsed.

Claims

1. An embolic protection device, comprising:

a first elongate member having a lumen;

a second elongate member extending through the lumen and being movable with respect to the first elongate member; and

a graft member constructed from a metal having a characteristic that is at least one of a superelastic material, a plastically deformable material and an elastic material, the graft member having a proximal end portion connected to the first elongate member and a distal end portion connected to the second elongate member, and a plurality of openings extending through the graft member along a length thereof;

the graft member being expandable from an undeployed generally tubular state to a deployed generally frustroconical state upon relative movement between the first and second elongate members in a first direction, the openings decreasing in size from the proximal end toward the distal end when the graft member is in the deployed state to thereby capture and retain emboli and other particulate matter of different sizes.

2. An embolic protection device according to claim 1, wherein the openings are substantially uniform in size when the graft member is in the undeployed state.

3. An embolic protection device according to claim 1, and further comprising a plurality of arm members extending between the first elongate member and the proximal end of the graft member, such that relative movement of the first and second elongate members in the first direction causes the arm members to move from a generally axial orientation to a generally radial orientation to thereby radially expand the proximal end of the graft member.

4. An embolic protection device according to claim 3, wherein the distal end of the graft member is substantially restrained against radial expansion such that the diameter of the graft member decreases from the proximal end toward the distal end when the graft member is in the deployed state.

5. An embolic protection device according to claim 4, wherein the size of each opening is proportional to the diameter of the graft member at which each opening is located.

6. An embolic protection device according to claim 5, wherein relative movement of the first and second elongate members in a second direction opposite the first direction causes the graft member to return to the undeployed state, thereby reducing the size of the openings at least at the proximal end, such that the emboli and other particulate matter can be entrapped within the graft member.

7. An embolic protection device according to claim 6, wherein the openings are substantially uniform in size when the graft member is in the undeployed state.

8. An embolic protection device according to claim 1, wherein the distal end of the graft member is substantially restrained against radial expansion such that the graft member decreases in diameter from the proximal end toward the distal end when the graft member is in the deployed state.

9. An embolic protection device according to claim 8, wherein the size of each opening is proportional to the diameter of the graft member at which each opening is located.

10. An embolic protection device according to claim 1, wherein relative movement of the first and second elongate members in a second direction opposite the first direction causes the graft member to return to the undeployed state, thereby reducing the size of the openings at least at the proximal end, such that the emboli and other particulate matter can be entrapped within the graft member.

11. An embolic protection device according to claim 1, wherein the graft member is constructed of a thin film metal.

12. An embolic protection device according to claim 11, wherein the thin film metal comprises a nickel titanium alloy.

13. An embolic protection device according to claim 1, wherein the graft member is constructed of braided wire.

14. An embolic protection device according to claim 1, wherein the first elongate member is a catheter.

15. An embolic protection device according to claim 14, wherein the second elongate member is a guide wire.

16. An embolic protection device according to claim 15, wherein the guide wire has an atraumatic tip at a distal end thereof.

17. An embolic protection device according to claim 1, wherein the second elongate member has a tubular distal portion, and further comprising a plurality of arm members integrally formed in the tubular portion in proximity with the proximal end of the graft member, the plurality of arm members being biased toward an expanded arm position and normally restrained in a retracted arm position by the first elongate member, such that relative movement of the first and second elongate members in the first direction causes the arm members to move from the retracted arm position toward the expanded arm position to thereby radially expand the proximal end of the graft member.

29. An embolic protection device according to claim 1, wherein when the graft member expands during movement from the undeployed state to the deployed state, both the geometry of the openings vary compared to the undeployed state and the size of the openings expand.

30. An embolic protection device according to claim 1, wherein the openings are longitudinal slots formed in a thin film metal when the graft member is in the undeployed state.

31. An embolic protection device according to claim 30, wherein when the graft member expands during movement from the undeployed state to the deployed state, both the geometry of the openings vary compared to the undeployed state and the size of the openings expand.

18. An embolic protection device comprising:

a catheter body having a central longitudinal lumen;

a guidewire having an atraumatic tip positioned at a distal end thereof, the guidewire being coaxially positioned within the central longitudinal lumen of the catheter body; and

a graft member movable between an undeployed state and a deployed state, the graft member being of a generally tubular shape in the undeployed state and of a generally frustroconical shape in the deployed state, the graft member comprising a plurality of openings extending along a longitudinal axis thereof, the openings decreasing in size from the proximal end toward the distal end when the graft member is in the deployed state, with a distal end of the graft member being connected to one of the guidewire and the atraumatic tip, the graft member being movable between the undeployed and deployed states upon relative movement between the catheter body and the guide wire, the graft member being constructed of a metal having a characteristic that is at least one of a superelastic material, a plastically deformable material and an elastic material such that each opening expands and reduces in size in proportion to an amount of radial expansion and reduction, respectively, of a corresponding transverse cross sectional region of the graft member with which the opening is associated, to thereby capture emboli and other particulate matter when the graft member is in the deployed state and minimize extrusion of the captured material through the openings in the graft member when the graft member is in the undeployed state.

19. An embolic protection device according to claim 18, wherein the openings are substantially uniform in size when the graft member is in the undeployed state.

20. An embolic protection device according to claim 18, wherein the distal end of the graft member is substantially restrained against radial expansion such that the graft member decreases in diameter from the proximal end toward the distal end when the graft member is in the deployed state.

21. An embolic protection device according to claim 18, wherein the graft member is constructed of a thin film metal.

22. An embolic protection device according to claim 21, wherein the thin film metal comprises a nickel titanium alloy.

23. An embolic protection device according to claim 18, wherein the graft member is constructed of braided wire.

24. An embolic protection device according to claim 18, wherein the guidewire has a tubular portion, and further comprising a plurality of arm members integrally formed in the tubular distal portion in proximity with the graft member, the tubular arm members being biased toward an expanded arm position and normally restrained in a retracted arm position by the catheter body, such that relative movement of the guidewire and catheter body direction causes the arm members to move from the retracted arm position toward the expanded arm position to thereby radially expand the proximal end of the graft member.

25. An embolic protection device according to claim 24, wherein the arm members are constructed of braided wire.

26. An embolic protection device according to claim 18, wherein when the graft member expands during movement from the undeployed state to the deployed state, both the geometry of the openings vary compared to the undeployed state and the size of the openings expand.

27. An embolic protection device according to claim 18, wherein the openings are in the form of longitudinal slots in a thin film metal when the graft member is in the undeployed state.

28. An embolic protection device according to claim 27, wherein when the graft member expands during movement from the undeployed state to the deployed state, both the geometry of the openings vary compared to the undeployed state and the size of the openings expand.