Embolic filter device and related systems and methods

• US 20060030876A1
• Filed: 04/29/2005
• Published: 02/09/2006
• Est. Priority Date: 10/29/2002
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Peacock, James C. III, Wasicek, Lawrence
• Application Number:
  US11/119,398
• Publication Number:
  US 20060030876A1
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An embolic filter system includes a filter device that is adapted to be positioned over a guidewire and locked onto the guidewire at the position. The filter device may be locked over the guidewire outside of the patient, and then the locked assembly is advanced within a delivery sheath to the desired filtering location where the filter is adjusted to an expanded configuration to filter emboli there. Or, the filter device in a radially collapsed configuration may be advanced over an indwelling guidewire by back-loading the guidewire into a guidewire lumen associated with the filter device. Once delivered to the desired filtering location along the guidewire, the filter is locked onto the guidewire and then expanded to the radially expanded configuration for filtering the emboli. A control system cooperates with the embolic filter device to selectively lock the embolic filter device onto the guidewire and to selectively adjust the filter assembly between radially collapsed and expanded configurations for delivery and filtering, respectively. The control system includes a locking system, which in one beneficial embodiment has at least one shape memory member that is adapted to be heated and reshaped to thereby lock onto the guidewire.

Claims

1-3. -3. (canceled)

4. An embolic filter system, comprising:

a delivery member with an elongate body with a proximal end portion and a distal end portion;

a filter assembly with a filter member having a wall with a substantially annular passageway around a circumference, and with a loop-shaped member coupled to the filter member within the annular passageway and along the circumference;

wherein the loop-shaped support member comprises a superelastic material and is adjustable between a radially collapsed condition corresponding with an elastically deformed condition for the superelastic material and a radially expanded condition according to material recovery from the elastically deformed condition to a superelastic shape memory condition for the superelastic material;

wherein adjusting the support member between the radially collapsed condition to the radially expanded condition at least in part adjusts the filter member between a radially collapsed configuration and a radially expanded configuration, respectively;

wherein the distal end portion of the delivery member is adapted to deliver the filter assembly to a location within a body lumen in a body of a patient with the support member radially confined in the radially collapsed condition and the filter member in the radially collapsed configuration and by manipulating the proximal end portion of the delivery member externally of the patient;

wherein the support member and filter member are adjustable from the radially collapsed condition and radially collapsed configuration, respectively, to the radially expanded configuration and radially expanded configuration, also respectively, at the location;

wherein the filter member in the radially expanded configuration at the location spans across a substantial cross-section of the body lumen and is adapted to filter components of fluid flowing through the body lumen at the location above a predetermined size.

5. An embolic filter system, comprising:

a delivery member with an elongate body having a proximal end portion and a distal end portion with a longitudinal axis, and a lumen extending between proximal and distal ports each being located along the distal end portion;

a filter assembly with a filter member that is adjustable from a radially collapsed configuration to a radially expanded configuration according to a material memory recovery from an elastically deformed condition toward a memory condition;

wherein the filter assembly in the radially collapsed configuration is radially confined within the lumen and is adapted to be delivered therein to a location within a body lumen in a body of a patient;

wherein the radially confining lumen has an adjustable position relative to the filter assembly at the location so as to release the filter assembly therefrom such that the filter member self-expands from the radially collapsed configuration to the radially expanded configuration at the location;

wherein the filter member in the radially expanded configuration at the location spans across a substantial cross-section of the body lumen; and

wherein the filter member in the radially expanded configuration at the location is adapted to filter components of fluid flowing through the body lumen at the location above a predetermined size.

6. A method for filtering emboli from fluid flowing across a location within a body lumen in a patient, comprising:

delivering a filter assembly in a radially collapsed configuration over a guidewire to the location;

locking the filter assembly onto the guidewire at the location;

adjusting the filter assembly locked onto the guidewire from the radially collapsed configuration to a radially expanded configuration at the location; and

wherein the filter assembly in the radially expanded configuration at the location spans across a substantial cross-section of the body lumen and is adapted to filter the emboli from the fluid flowing across the location.

7. A method for filtering emboli from fluid flowing across a location within a body lumen in a patient, comprising:

delivering a filter assembly with a delivery member in a radially collapsed configuration over a guidewire to the location;

detaching the filter assembly from the delivery member at the location;

adjusting the filter assembly from the radially collapsed configuration to a radially expanded configuration at the location; and

wherein the filter assembly in the radially expanded configuration at the location spans across a substantial cross-section of the body lumen and is adapted to filter the emboli from the fluid flowing across the location.

8. A method for filtering emboli from fluid flowing across a location within a body lumen in a patient, comprising:

positioning a filter assembly in a radially collapsed configuration within a capture lumen of a radially confining cuff having an adjustable position relative to the filter assembly;

providing the filter assembly in the radially collapsed configuration within the adjustable radially confining cuff along a distal end portion of a delivery member;

delivering the distal end portion of the delivery member and filter assembly in the radially collapsed condition within the cuff to the location;

adjusting the filter assembly from the radially collapsed configuration to a radially expanded configuration at the location by adjusting the relative position of the cuff relative to the filter assembly such that the filter assembly is released from radial confinement and self-expands according to material memory to the radially expanded condition;

wherein the filter assembly in the radially expanded configuration at the location spans across a substantial cross-section of the body lumen and is adapted to filter the emboli from the fluid flowing across the location; and

wherein the capture lumen extends along a length between proximal and distal ports and is adapted to be located entirely within the body lumen.

9-13. -13. (canceled)

22. (canceled)

24. (canceled)

27-28. -28. (canceled)

30-31. -31. (canceled)

33. (canceled)

35-37. -37. (canceled)

39-56. -56. (canceled)

59-61. -61. (canceled)

65-66. -66. (canceled)

67. An embolic filter system, comprising:

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to slideably engage and track over a guidewire to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration; and

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location.

68. An embolic filter system, comprising:

a delivery member;

a filter assembly with a filter member;

wherein the delivery member is detachably coupled to the filter assembly;

wherein the filter assembly is adapted to be advanced over a guidewire with the delivery member to a location within a body lumen in a body of a patient; and

wherein the delivery member is adapted to be detached from the filter assembly at the location.

69. An embolic filter system, comprising:

a delivery member;

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to be advanced over a guidewire with the delivery member to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration;

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location; and

wherein the filter assembly is adapted to be detached from the delivery member at the location.

57. The system of claim 69, wherein:

the delivery member comprises a proximal end portion and a distal end portion that is detachably coupled to the filter assembly; and

the proximal end portion of the delivery member comprises a wire.

58. The system of claim 69, wherein:

the delivery member comprises a proximal end portion and a distal end portion that is detachably coupled to the filter assembly; and

the proximal end portion of the delivery member comprises a tubular member.

62. The system of claim 69, wherein the filter member comprises a porous polymer material.

63. The system of claim 62, wherein the porous polymer comprises a porous polytetrafluoroethylene material.

64. The system of claim 69, wherein the filter member comprises an expandable cage of filament members.

70. An embolic filter system, comprising:

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to slideably engage and track over a guidewire to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration; and

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location; and

wherein the adjustable lock assembly comprises a locking member that is adjustable between a first shape and a second shape, the first shape corresponding with the open configuration, and the second shape corresponding with the locked configuration.

14. The system of claim 70, wherein:

the locking member comprises an annular wall with a circumference around an inner passageway with an inner diameter;

the first shape comprises a first inner diameter; and

the second shape comprises a second inner diameter that is less than the first inner diameter.

15. The system of claim 14, wherein the locking member comprises a composite tube-shaped member.

16. The system of claim 15, wherein the composite tube-shaped member comprises a nickel-titanium support structure coupled to an elastomeric wall.

17. The system of claim 14, wherein the locking member comprises an annular cuff coupled to a portion of a tubular member.

18. The system of claim 14, wherein the adjustable lock assembly comprises a plurality of said locking members, each locking member comprises a discretely located annular cuff coupled to a portion of a tubular member.

19. The system of claim 70, wherein:

the locking member comprises a shape memory material that is adjustable between the first shape and the second shape according to material recovery to a memory shape upon a change of temperature above a predetermined temperature.

20. The system of claim 70, wherein:

the adjustable lock assembly is adapted to apply an electrical current to the locking member at the location; and

the locking member is adapted to heat above the predetermined temperature in response to the applied electrical current at the location.

21. The system of claim 70, wherein

the adjustable lock assembly comprises an electrical conductor and is adapted to form a monopolar electrical lead at the location within the lumen of the patient;

the adjustable lock assembly is adapted to apply a radiofrequency (RF) current between the electrical conductor and a second electrical lead coupled to the patient; and

the locking member is adapted to heat above a predetermined temperature in response to the applied RF current at the location.

23. The system of claim 70, wherein

the locking member comprises an electrical conductor and is adapted to be electrically coupled to an electrical current source in a closed loop electrical circuit through the locking member;

wherein the locking member is adapted to undergo resistance heating above the predetermined temperature in response to an applied electrical current in the closed loop electrical circuit.

25. The system of claim 70, wherein the adjustable lock assembly further comprises:

a convection heater thermally coupled to the locking member;

wherein the convection heater is adapted to be actuated to convect sufficient heat toward the locking member so as to raise the temperature of the locking member above a predetermined temperature at the location.

26. The system of claim 70, wherein the adjustable lock assembly further comprises:

an ultrasound emitter that is adapted to be ultrasonically coupled to the locking member sufficient to raise the temperature of the locking member above the a predetermined temperature at the location.

29. The system of claim 70, wherein the adjustable lock assembly further comprises a microwave element that is adapted to inductively heat the locking member at the location.

32. The system of claim 70, further comprising:

an optical coupler that is adapted to couple light from a light emitter and to transmit the light to the adjustable lock assembly.

34. The system of claim 70, wherein:

the locking member comprises a superelastic material;

the first shape corresponds with a superelastically deformed condition for the superelastic material; and

the adjustment from the first shape to the second shape corresponds with a superelastic material recovery from the deformed condition to a superelastic memory shape condition.

38. The system of claim 70, wherein:

the locking member comprises an inflatable bladder that is adapted to be located between the filter assembly and the distal end portion of the guidewire at the location and to couple to a source of pressurizeable fluid externally of the patient; and

the inflatable bladder is adjustable from a collapsed condition that is substantially uninflated and corresponds with the open configuration for the adjustable lock assembly to an inflated condition that is inflated with fluid from the source and corresponds with the locked configuration for the adjustable lock assembly.

71. An embolic filter system, comprising:

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to slideably engage and track over a guidewire to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration;

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location; and

wherein the adjustable lock assembly is adapted to deliver a material between the filter assembly and the guidewire that secures the filter assembly to the guidewire in the locked configuration.

72. An embolic filter system, comprising:

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to slideably engage and track over a guidewire to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration;

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location; and

wherein the adjustable lock assembly comprises a material and is adapted to melt the material between a first condition corresponding with the open configuration and a second condition corresponding with the locked configuration and that is adapted to secure the filter assembly to the guidewire.

73. An embolic filter system, comprising:

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to slideably engage and track over a guidewire to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration;

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location; and

wherein the adjustable lock assembly in the locked configuration comprises an adhesive located between the filter assembly and the guidewire and securing the filter assembly to the guidewire.

74. An embolic filter system, comprising:

a delivery assembly with a delivery member;

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to be advanced over a guidewire with the delivery member to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration;

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location;

wherein the filter assembly is adapted to be detached from the delivery member at the location;

wherein the delivery assembly further comprises a capture lumen extending between proximal and distal ports located along the distal end portion of the delivery assembly, respectively;

wherein the filter assembly in the radially collapsed configuration is radially confined within the capture lumen and is adapted to be delivered therein to the location; and

wherein the capture lumen has an adjustable position relative to the filter assembly at the location so as to release the filter assembly therefrom such that the filter member self-expands from the radially collapsed configuration to the radially expanded configuration at the location.

75. An embolic filter system, comprising:

a delivery member;

a filter assembly with a filter member;

wherein the delivery member is detachably coupled to the filter assembly;

wherein the filter assembly is adapted to be advanced over a guidewire with the delivery member to a location within a body lumen in a body of a patient;

wherein the delivery member is adapted to be detached from the filter assembly at the location;

wherein the delivery member is detachably coupled to the filter assembly via an electrolytically sacrificial joint; and

wherein the electrolytically sacrificial joint is adapted to be coupled to a current source in an electrical circuit that includes the joint at the location such that the delivery member is detachable from the filter assembly by electrolytic dissolving of the joint.

76. An embolic filter system, comprising:

a delivery member;

a filter assembly with a filter member;

wherein the delivery member is detachably coupled to the filter assembly;

wherein the filter assembly is adapted to be advanced over a guidewire with the delivery member to a location within a body lumen in a body of a patient;

wherein the delivery member is adapted to be detached from the filter assembly at the location;

wherein the delivery member comprises multiple conductors, each conductor being detachably coupled to the filter assembly via an electrolytically sacrificial joint; and

wherein each electrolytically sacrificial joint is adapted to be coupled to a current source in an electrical circuit that includes the joint at the location such that the distal end portion is detachable from the filter assembly by electrolytic dissolving of each joint.

77. An embolic filter system, comprising:

a delivery member;

a filter assembly with a filter member;

wherein the delivery member is detachably coupled to the filter assembly;

wherein the filter assembly is adapted to be advanced over a guidewire with the delivery member to a location within a body lumen in a body of a patient;

wherein the delivery member is adapted to be detached from the filter assembly at the location; and

the delivery member is adapted to be mechanically detached from the filter assembly at the location.

78. An embolic filter system, comprising:

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to slideably engage and track over a guidewire to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration;

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location; and

wherein the adjustable lock assembly is adapted to mechanically engage the guidewire with an applied force onto the guidewire in the locked configuration.

79. An embolic filter system, comprising:

a filter assembly with a filter member and an adjustable lock assembly;

wherein the adjustable lock assembly is adjustable between an open configuration and a locked configuration;

wherein the filter assembly is adapted to slideably engage and track over a guidewire to a location within a body lumen in a body of a patient with the adjustable lock assembly in the open configuration;

wherein the adjustable lock assembly is adjustable at the location from the open configuration to the locked configuration that is adapted to lock the filter assembly at a selected position onto a distal end portion of the guidewire at the location; and

wherein the adjustable lock assembly comprises a pressurizeable bladder that is adapted to mechanically engage the guidewire with an applied force onto the guidewire in the locked configuration.