Embolic protection device

• US 20050209635A1
• Filed: 03/01/2005
• Published: 09/22/2005
• Est. Priority Date: 11/07/1997
• Status: Abandoned Application

• Current Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Original Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Inventors: Brady, Eamon, Vale, David, Taylor, Charles, Maher, Padraig, Gilson, Paul
• Application Number:
  US11/068,529
• Publication Number:
  US 20050209635A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2002/015 Stop means therefor
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped

Abstract

An embolic protection device has a collapsible filter element (105) mounted on a carrier such as a guidewire (101). The filter element (105) collapses into the outer end of a catheter (118) for deployment and retrieval through a vascular system of a patient. The filter element (105) has a collapsible filter body with a proximal inlet end and a distal outlet end. The proximal inlet end has inlet openings sized to allow blood and embolic material enter the filter body. The outlet end has outlet openings which allow through passage of blood but retain embolic material within the filter body. After use, the catheter (118) is movable along the guidewire (101) to engage the proximal end of the filter element and close the inlet openings before sliding over the filter element from the proximal end to the distal end to progressively collapse the filter body on the guidewire (101) for retrieval. The filter element (105) may conveniently be mounted on a tubular sleeve (104) which is slidable and rotatable on the guidewire (101) between spaced-apart stops (106, 120) on the guidewire (101) which allows some manipulation of the guidewire independently of the filter when the filter is in use.

Claims

1-42. -42. (canceled)

43. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site; and

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an articulating element, for enabling the filter device to articulate so as to move and flex during insertion through the blood vessel, and to expand against the inner surface of the wall of the blood vessel, and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow.

44. The system of claim 43, wherein the filter device includes a cage, secured to the distal end of the guide wire, and filter material, for filtering embolic material, secured to the cage.

45. The system of claim 43, wherein the cage includes a plurality of struts, each of which includes a plurality of proximal ribs, a plurality of distal ribs, and a ring which extends intermediate the plurality of proximal ribs and the plurality of distal ribs, which forms a proximal junction between the plurality of proximal ribs, and a distal junction between the plurality of distal ribs, and wherein the articulating element includes a proximal articulating element, located at the proximal junction, and a distal articulating element, located at the distal junction.

46. The system of claim 45, further comprising a fitting, secured to the distal end of the guide wire, and wherein the plurality of proximal ribs are connected to the fitting.

47. The system of claim 45, wherein the ring includes a plurality of segments, each of which includes a proximal portion and a distal portion, and wherein each pair of segments which are adjacent to each other at the proximal ends thereof comprise proximal adjacent segments, and each pair of segments which are adjacent to each other at the distal ends thereof comprise distal adjacent segments.

48. The system of claim 47, wherein each of the plurality of proximal ribs includes a distal portion, each of the plurality of distal ribs includes a proximal portion, each pair of proximal adjacent segments form a junction therebetween which comprises a proximal junction, the proximal junction is in the form of a partial loop which comprises a proximal partial loop, the distal portion of each of the plurality of proximal ribs is in the form of a loop which comprises a distal loop, and each distal loop is engaged with each proximal partial loop comprising proximal engaged loops

and partial loops, each pair of distal adjacent segments form a junction therebetween which comprises a distal junction, the distal junction is in the form of a partial loop which comprises a distal partial loop, the proximal end of each of the plurality of distal ribs is in the form of a loop which comprises a proximal loop, and each proximal loop is engaged with each distal partial loop, comprising distal engaged loops and partial loops, and wherein the proximal articulating element comprises the proximal engaged loops and partial loops, and the distal articulating element comprises the distal engaged loops and partial loops.

49. The system of claim 47, wherein the plurality of segments of the ring define a contour thereof.

50. The system of claim 49, wherein the filter device includes filter material, secured to the plurality of segments of the ring, the filter material includes a proximal portion and a distal portion, and the proximal portion of the filter material includes a contour which corresponds generally to the contour defined by the plurality of segments of the ring.

51. The system of claim 49, wherein the contour defined by the plurality of segments of the ring is generally right-angle-bracket shaped.

52. The system of claim 43, wherein the cage includes a plurality of struts, each of which includes a plurality of proximal ribs, a plurality of distal ribs, and a ring which extends intermediate the plurality of proximal ribs and the plurality of distal ribs, which forms a distal junction between the plurality of distal ribs, and

wherein the articulating element comprises a distal articulating element, located at the distal junction.

53. The system of claim 52, wherein the ring includes a plurality of segments, each of which includes a proximal portion and a distal portion, and wherein each pair of segments which are adjacent to each other at the distal ends thereof comprise distal adjacent segments.

54. The system of claim 53, wherein each of the plurality of proximal ribs includes a distal portion, each of the plurality of distal ribs includes a proximal portion, each pair of distal adjacent segments form a junction therebetween which comprises a distal junction, the distal junction is in the form of a partial loop which comprises a distal partial loop, the proximal end of each of the plurality of distal ribs is in the form of a loop, which comprises a proximal loop, and each proximal loop is engaged with each distal partial loop comprising distal engaged loops and partial loops, and wherein the distal articulating element comprises the distal engaged loops and partial loops.

55. The system of claim 53, wherein the plurality of segments of the ring define a contour thereof.

56. The system of claim 55, wherein the filter device includes filter material, secured to the plurality of segments of the ring, the filter material includes a proximal portion and a distal portion, and the proximal portion of the filter material includes a contour which corresponds generally to the contour defined by the plurality of segments of the ring.

57. The system of claim 55, wherein the contour defined by the plurality of segments of the ring is generally right-angle-bracket shaped.

58. The system of claim 43, wherein the cage includes a plurality of struts, each of which includes a plurality of proximal ribs, a plurality of distal ribs, and a ring which extends intermediate the plurality of proximal ribs and the plurality of distal ribs, which forms a proximal junction between the plurality of proximal ribs, and wherein the articulating element comprises a proximal articulating element, located at the proximal junction.

59. The system of claim 58, wherein the ring includes a plurality of segments, each of which includes a proximal portion and a distal portion, and wherein each pair of segments which are adjacent to each other at the proximal ends thereof comprise proximal adjacent segments.

60. The system of claim 59, wherein each of the plurality of proximal ribs includes a distal portion, each of the plurality of distal ribs includes a proximal portion, each pair of proximal adjacent segments form a junction therebetween which comprises a proximal junction, the proximal junction is in the form of a partial loop which comprises a proximal partial loop, the distal portion of each of the plurality of proximal ribs is in the form of a loop, which comprises a distal loop, and each distal loop is engaged with each proximal partial loop comprising proximal engaged loops and partial loops, and wherein the proximal articulating element comprises the proximal engaged loops and partial loops.

61. The system of claim 59, wherein the plurality of segments of the ring define a contour thereof.

62. The system of claim 61, wherein the filter device includes filter material, secured to the plurality of segments of the ring, the filter material includes a proximal portion and a distal portion, and the proximal portion of the filter material includes a contour which corresponds generally to the contour defined by the plurality of segments of the ring.

63. The system of claim 61, wherein the contour defined by the plurality of segments of the ring is generally right-angle-bracket shaped.

64. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site; and

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an articulating element, for enabling the filter device to be inserted through the blood vessel so as to move and flex to articulate therein, for enabling the filter device to navigate through confined spaces therein.

65. The system of claim 64, wherein the filter device includes a cage, secured to the distal end of the guide wire, and filter material, for filtering embolic material, secured to the cage.

66. The system of claim 65, wherein the cage includes a plurality of struts, each of which includes a plurality of proximal ribs, and wherein each of the plurality of proximal ribs includes the articulating element therein.

67. The system of claim 66, wherein each of the plurality of proximal ribs includes a proximal end and a distal end, and the articulating element comprises a generally u-shaped portion of the proximal portion of each of the plurality of proximal ribs, spaced from the proximal end and the distal end thereof.

68. The system of claim 66, wherein each of the plurality of proximal ribs includes a proximal end and a distal end, and the articulating element comprises a generally w-shaped portion of the proximal portion of each of the plurality of proximal ribs, spaced from the proximal end and the distal end thereof.

69. A method of enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site, and a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an

articulating element, for enabling the filter device to articulate so as to move and flex during insertion through the blood vessel, and to expand against the inner surface of the wall of the blood vessel, and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow, wherein the method comprises:

inserting the guide wire, and the filter device secured to the distal end thereof, through the blood vessel, to the position distal to the interventional procedure site; and

deploying the filter device at the position distal to the interventional procedure site, wherein the articulating element articulates, enabling the filter device to expand against the inner surface of the wall of the blood vessel, and seal off the inner surface of the blood vessel wall, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow.

70. A method of enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises, a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site, and a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an articulating element, for enabling the filter device to be inserted through the blood

vessel so as to move and flex to articulate therein, for enabling the filter device to navigate through confined spaces therein, wherein the method comprises:

inserting the guide wire, and the filter device secured thereto and unexpanded within a delivery sheath, through the blood vessel, to the position distal to the interventional procedure site, wherein the articulating element articulates, enabling the filter device to navigate through confined spaces in the blood vessel; and

deploying the filter device at the position distal to the interventional procedure site.

71. A distal protection device disposable within a vessel of a body, comprising:

a filter basket positionable at a desired axial location within the vessel, said filter basket having a closed distal end and an open proximal end;

a guidewire upon which said filter basket is mounted; and

a self-expanding arcuate member that, when expanded, creates a radial force against a vessel wall to control the lateral position of the filter at a desired location in the blood vessel.

72. The device of claim 71, wherein the self-expanding member is carried by the guidewire.

73. The device of claim 72, wherein the self-expanding member resists lateral force of the guidewire to maintain the lateral position of the filter basket.

74. The device of claim 72, wherein the self-expanding member exerts a radial force on the guidewire in proximity to the proximal end of the filter basket.

75. The device of claim 71, wherein the self-expanding member, in its expanded state, is deployed at an angle of between 45°

and 90°

to said guidewire.

76. The device of claim 71, wherein the self-expanding member is in proximity to the proximal end of the filter basket.

77. Apparatus to facilitate proper positioning of a medical device within a generally tubular vessel of the body along a guidewire fed into the vessel, comprising:

an element maintaining the medical device deployed laterally on a defined side of the guidewire; and

a collapsible, quasi-rigid spacer carried by the guidewire proximate a desired axial end of the medical device, and maintained, when expanded, deployed laterally on the defined side of the guidewire, said spacer having a dimension on the defined side of the guidewire sufficient to engage an inner surface of the vessel at a circumferential location and urge the guidewire against the inner surface of the vessel at a generally diametrically opposite location.

78. Apparatus in accordance with claim 77, wherein said spacer has a proximal portion at the guidewire and a distal portion for engagement of the inner surface of the vessel, and wherein said distal portion is configured so as not to injure the inner surface of the vessel.

79. Apparatus in accordance with claim 78, wherein said spacer comprises a wire form, and wherein said distal portion of said spacer comprises an arcuate portion of said wire form.

80. Apparatus in accordance with claim 79, wherein said wire form defines a closed loop.

81. Apparatus in accordance with claim 80, wherein said closed loop generally defines an angle of at least 45°

relative to the guidewire.

82. Apparatus in accordance with claim 79, wherein said wire form defines a generally C shape.

83. Apparatus in accordance with claim 79, wherein said wire form defines a generally J shape.

84. Apparatus in accordance with claim 78, wherein said spacer is radiopaque.

85. Apparatus in accordance with claim 77, wherein said spacer has a distal portion at the guidewire and a proximal portion for engagement of the inner surface of the vessel, and wherein said proximal portion is configured so as not to injure the inner surface of the vessel.

86. Apparatus to facilitate proper positioning of a medical device within a generally tubular vessel of the body along a guidewire fed into the vessel, comprising:

an element mounting the medical device to the guidewire at a defined axial position along the guidewire; and

a collapsible, quasi-rigid spacer carried by the element, wherein said device is generally axially aligned with said spacer, said spacer having a dimension on one side of the guidewire sufficient so that it engages an inner surface of the vessel at a circumferential location thereon and urges the guidewire against the inner surface of the vessel at a generally diametrically opposite location.

87. A distal protection device disposable within a vessel of a body, comprising:

a filter basket positionable at a desired axial location within the vessel, said filter basket having a closed distal end and an open proximal end;

a guidewire upon which said filter basket is mounted; and

a generally radially self-expanding quasi-rigid member associated with said filter basket in proximity to the proximal end thereof, and wherein the filter basket and self-expanding member are each mounted on the guidewire and generally axially aligned with each other, said self-expanding member, in its expanded state, having a dimension on one side of the guidewire sufficient so that it engages an inner surface of the vessel at a circumferential location thereon and urges the guidewire toward the inner surface of the vessel at a generally diametrically opposite location.

88. The distal protection device of claim 87, wherein at least one end of said filter basket is free-floating along said guidewire.

89. The distal protection device of claim 88, wherein an opposite end of said filter basket is fixedly attached to said guidewire.

90. The distal protection device of claim 88, wherein said filter basket is in the shape of a windsock and said guidewire extends axially along said windsock.

91. The distal protection device of claim 90, wherein said guidewire extends axially within the windsock.

92. The distal protection device of claim 88, wherein said filter basket includes a tube through which said guidewire extends, and wherein a proximate end of said filter basket cooperates with said guidewire in a manner which allows said proximate end to move axially on the guidewire until it engages an end of the tube.

93. The distal protection device of claim 87, wherein said self-expanding member comprises a loop, and wherein said loop is generally circular in shape.

94. The distal protection device of claim 87, wherein said self-expanding member is formed in a “

C”

configuration.

95. The distal protection device of claim 87, wherein said self-expanding member is formed in a “

J”

configuration.

96. The distal protection device of claim 87, wherein said self-expanding member is formed in a spiral configuration.

97. The distal protection device of claim 87, wherein the self-expanding member is made of nitinol wire.

98. The distal protection device of claim 87, wherein the self-expanding member is radiopaque.

99. The distal protection device of claim 87, wherein the self-expanding member is covered by a radiopaque material.

100. The distal protection device of claim 87, wherein the self-expanding member, in its expanded state, generally defines a plane substantially perpendicular to said guidewire.

101. The distal protection device of claim 87, wherein said self-expanding member, in its expanded state, is deployed at an angle of between 45°

and 90°

to said guidewire.

102. The distal protection device of claim 87, wherein said filter basket and said self-expanding member are adapted to be collapsed to fit into a small diameter delivery catheter.

103. A distal protection device disposable within a vessel of a body, comprising:

a filter basket positionable at a desired axial location within the vessel, said filter basket having a closed distal end and an open proximal end;

a guidewire upon which said filter basket is mounted, said guidewire extending axially along said filter basket proximate a location on a periphery of a mouth defined by said open proximal end; and

a self-expanding arcuate member that, when expanded, creates a radial force against a vessel wall to control the lateral position of the guidewire at a desired location in the blood vessel.