ROTATIONAL ATHERECTOMY DEVICE WITH FLUID INFLATABLE SUPPORT ELEMENTS AND TORQUE TRANSMITTING MEMBRANE

• US 20090318942A1
• Filed: 06/28/2007
• Published: 12/24/2009
• Est. Priority Date: 07/13/2006
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Lela Nadirashvili
• Inventors: Shturman, Leonid
• Granted Patent: US 8,142,458 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient is disclosed. The device comprises a rotatable, flexible, hollow drive shaft having a fluid impermeable wall defining a lumen of the drive shaft and, an abrasive element mounted to a distal end portion of the drive shaft proximal to and spaced away from a distal support element formed at a distal end of the drive shaft. The distal support element is inflatable by pressurized fluid which flows in an antegrade direction through said lumen of the drive shaft and is least partially re-directed into the distal fluid inflatable support element. The distal fluid inflatable support element has an outer wall comprising an outflow opening located such that said outflow opening faces an inner surface of a treated vessel during rotation of the drive shaft so that a flow of fluid through said outflow opening forms a layer of fluid between the outer wall of the rotating fluid inflated distal support element and a wall of the treated vessel to form a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel. The fluid impermeable drive shaft comprises at least one torque transmitting coil and at least one fluid impermeable membrane which extends beyond a distal end of the torque transmitting coil and conveys torque to the abrasive element mounted to the drive shaft distal to and spaced away from the distal end of the torque transmitting coil.

Claims

1-57. -57. (canceled)

58. A rotational atherectomy device for removing a stenotic lesion from a vessel of a patient, the device comprising an abrasive element mounted to a distal end portion of a rotatable, flexible, hollow drive shaft between and spaced away from a pair of support elements located on the drive shaft distal and proximal to the abrasive element, the distal support element being located at a distal end of the drive shaft and having a fluid inflatable space which is in fluid communication with a distal end portion of a guide wire lumen of the drive shaft, the guide wire lumen having a proximal end portion located outside of the patient and a fluid impermeable wall which extends along an entire length of the guide wire lumen, the distal support element being inflatable by pressurized fluid which is pumped into the proximal portion of the fluid impermeable guide wire lumen, flows in an antegrade direction through said lumen and is at least partially re-directed into the distal fluid inflatable support element, the fluid impermeable guide wire lumen being configured for advancement of the drive shaft over a guidewire across the stenotic lesion to be treated and for transfer of pressurized fluid into the fluid inflatable space of the distal support element after crossing the stenotic lesion and removing the guidewire from the drive shaft or withdrawing it into the drive shaft, the drive shaft having a longitudinal axis and the abrasive element and each of the support elements having their individual centers of mass, the center of mass of the abrasive element being spaced radially away from the longitudinal axis of the drive shaft while the center of mass of the distal support element and the centre of mass of the proximal support element each coincide with the longitudinal axis of the drive shaft.

59. A rotational atherectomy device according to claim 58, wherein the drive shaft is provided with a valve located at a distal end of the fluid impermeable guide wire lumen, said valve being configured to occlude the distal end of the guide wire lumen and assist in re-directing flow of fluid into the distal fluid inflatable support element after crossing the stenotic lesion to be treated and removing the guidewire from the drive shaft.

60. A rotational atherectomy device according to claim 58, wherein a flexible leaf valve is formed at a distal end of the fluid impermeable guide wire lumen, the flexible leaf valve having a proximal edge which is free and is movable across the fluid impermeable guide wire lumen between closed and open positions of the leaf valve, the leaf valve is moved to the open position by a guidewire when the drive shaft is advanced over the guidewire and is forced into its closed position by pressure of fluid which is pumped in the antegrade direction through the fluid impermeable guide wire lumen after advancing the drive shaft over the guidewire across the stenotic lesion to be treated and removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

61. A rotational atherectomy device according to claim 58, wherein the distal fluid inflatable support element has an outer wall which comprises an outflow opening located such that said outflow opening faces an inner surface of a treated vessel during rotation of the drive shaft, the outflow opening having an axis which forms an angle of about ninety (90) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated, so that in a rotating fluid inflated distal support element flow of fluid through the outflow opening forms a layer of fluid between the outer wall of the fluid inflated distal support element and a wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel, the fluid bearing permitting safe rotation and back and forth movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

62. A rotational atherectomy device for removing a stenotic lesion from a vessel of a patient, the device comprising an abrasive element mounted to a distal end portion of a rotatable, flexible, hollow drive shaft proximal to and spaced away from a fluid inflatable distal support element formed at a distal end of the drive shaft, the drive shaft having a longitudinal axis and a fluid impermeable wall which extends along an entire length of the drive shaft and defines a fluid impermeable guide wire lumen of the drive shaft, the fluid impermeable guide wire lumen being configured for advancement of the drive shaft over a guidewire across the stenotic lesion and for transfer of pressurized fluid into a fluid inflatable space of the distal support element after crossing the stenotic lesion and removing the guidewire from the drive shaft or withdrawing it into the drive shaft, the distal support element being inflatable by pressurized fluid which enters the fluid impermeable guide wire lumen through its proximal end, flows in an antegrade direction through the lumen and is at least partially re-directed into the distal fluid inflatable support element, the proximal end of the fluid impermeable guide wire lumen being located outside of the patient and pressurized fluid being pumped into the fluid impermeable guide wire lumen in the antegrade direction along the longitudinal axis of the drive shaft, the distal fluid inflatable support element having an outer wall comprising an outflow opening located such that said outflow opening faces an inner surface of a treated vessel during rotation of the drive shaft, the outflow opening having an axis which forms an angle of at least about seventy five (75) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated, so that in a rotating fluid inflated distal support element flow of fluid through the outflow opening forms a layer of fluid between the outer wall of the rotating fluid inflated distal support element and a wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel, the fluid bearing permitting safe rotation and back and forth movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

63. A rotational atherectomy device according to claim 62, wherein the drive shaft is comprised of at least one torque transmitting coil and at least one fluid impermeable membrane which extends beyond a distal end of the torque transmitting coil and conveys torque to the abrasive element mounted to the drive shaft distal to and spaced away from the distal end of the torque transmitting coil.

64. A rotational atherectomy device according to claim 63, wherein the fluid impermeable membrane extends distally beyond the abrasive element and is folded back on itself at the distal end of the drive shaft to form the distal fluid inflatable support element between an inner and outer layers of said folded membrane, the outer layer of the membrane forming an outer wall of the distal fluid inflatable support element and the inner layer of the membrane forming an inner wall of the distal fluid inflatable support element, the inner wall of the inflatable support element having an aperture therein so that a portion of fluid flowing in the antegrade direction through the fluid impermeable guide wire lumen is re-directed through the aperture into the distal fluid inflatable support element to inflate said distal support element.

65. A rotational atherectomy device according to claim 62, wherein a flexible leaf valve is formed at a distal end of the fluid impermeable guide wire lumen, the flexible leaf valve having a proximal edge which is free and is movable across the fluid impermeable guide wire lumen between closed and open positions of the leaf valve, the leaf valve is moved to the open position by a guidewire when the drive shaft is advanced over the guidewire and is forced into its closed position by pressure of fluid which is pumped in the antegrade direction through the fluid impermeable guide wire lumen after advancing the drive shaft over the guidewire across the stenotic lesion to be treated and removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

66. A rotational atherectomy device according to claim 62, wherein the outer wall of the distal fluid inflatable support element has a plurality of outflow openings located such that at least one of said outflow openings faces an inner surface of a treated vessel during rotation of the drive shaft, the outflow openings having axes which form angles of about ninety (90) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated, so that in a rotating fluid inflated distal support element flows of fluid through the outflow openings form a layer of fluid between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel, the fluid bearing permitting safe rotation and back and forth movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

67. A rotational atherectomy device according to claim 62, wherein the drive shaft is provided with a proximal fluid inflatable support element located proximal to and spaced away from the abrasive element, the proximal support element being inflatable by pressurized fluid which flows in the antegrade direction through the fluid impermeable guide wire lumen of the drive shaft and is re-directed into the proximal inflatable support element, the proximal fluid inflatable support element having an outer wall which comprises an outflow opening located such that an axis of the outflow opening forms an angle of at least about seventy five (75) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated, said outflow opening facing an inner surface of a treated vessel during rotation of the drive shaft and a flow of fluid through the outflow opening forming a layer of fluid between the outer wall of the rotating fluid inflated proximal support element and the wall of the treated vessel, the layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated proximal support element and the wall of the treated vessel.

68. A rotational atherectomy device according to claim 62, wherein the drive shaft is provided with a proximal fluid inflatable support element located proximal to and spaced away from the abrasive element, both support elements being inflatable by pressurized fluid which flows in the antegrade direction through the fluid impermeable guide wire lumen and is re-directed into the inflatable support elements, both support elements having fluid inflatable spaces that extend only partially around a circumference of the drive shaft so that, when both support elements are inflated by fluid, their centers of mass become offset from the longitudinal axis of the drive shaft in one direction and the distal and proximal fluid inflatable support elements act as counterweights to the abrasive element which is located on the drive shaft between the support elements and has its centre of mass offset from the longitudinal axis of the drive shaft in the opposite direction.

69. A rotational atherectomy device according to claim 62, wherein a fluid inflatable space within the distal fluid inflatable support element extends uniformly around an entire circumference of the drive shaft to provide the distal support element with a centre of mass which coincides with the longitudinal axis of the drive shaft when said distal support element is fluid inflated.

70. A rotational atherectomy device according to claim 69, wherein the abrasive element has its center of mass spaced away from the longitudinal axis of the drive shaft.

71. A rotational atherectomy device according to claim 62, wherein there is a plurality of outflow openings in the outer wall of the fluid inflatable distal support element, said openings being located around a maximum circumference of the outer wall of the fluid inflatable distal support element such that, during rotation of the drive shaft, at least some of said openings face an inner surface of the treated vessel and flows of fluid through the openings form a layer of fluid between the outer wall of the fluid inflated distal support element and the wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel, the fluid bearing permitting safe rotation and back and forward movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

72. A rotational atherectomy device according to claim 62, wherein the drive shaft is provided with a proximal fluid inflatable support element located proximal to and spaced away from the abrasive element, both the distal and proximal support elements being inflatable by pressurized fluid which flows in the antegrade direction through the fluid impermeable guide wire lumen and is re-directed into the inflatable support elements, both the distal and proximal support elements having fluid inflatable spaces that extend uniformly around an entire circumference of the drive shaft and are defined by outer walls of the support elements, the outer walls of the inflatable support elements comprising multiple outflow openings, said openings being located around a maximum circumference of the outer walls of the fluid inflatable support elements such that, during rotation of the drive shaft, said openings face an inner surface of the treated vessel and flows of fluid through the openings form layers of fluid between the outer walls of the fluid inflated support elements and the wall of the treated vessel, said layers of fluid forming fluid bearings between the outer walls of the rotating fluid inflated support elements and the wall of the treated vessel, the fluid bearings permitting safe rotation and back and forth movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

73. A rotational atherectomy device according to claim 72, wherein the abrasive element has its center of mass spaced away from the longitudinal axis of the drive shaft.

74. A rotational atherectomy device according to claim 62, wherein the drive shaft is provided with a solid proximal support element located proximal to and spaced away from the abrasive element, the solid proximal support element having a rounded outer surface and comprising at least one outflow channel which extends radially outward from the fluid impermeable guide wire lumen of the drive shaft and has an outflow opening in the rounded outer surface of the solid support element, the outflow channel having an axis which forms an angle of at least about seventy five (75) degrees with the longitudinal axis of the drive shaft so that, during rotation of the drive shaft, the outflow opening on the rounded outer surface of the solid support element is facing an inner surface of the treated vessel and a flow of fluid out of said outflow opening forms a layer of fluid between the solid proximal support element and the wall of the treated vessel, said layer of fluid forming a fluid bearing between the rotating solid proximal support element and the wall of the treated vessel.

75. A rotational atherectomy device according to claim 62, wherein the abrasive element has its center of mass spaced away from the longitudinal axis of the drive shaft.

76. A rotational atherectomy device according to claim 62, wherein the centre of mass of the abrasive element coincides with the longitudinal axis of the drive shaft.

77. A rotational atherectomy device according to claim 62, wherein the abrasive element extends around an entire circumference of the drive shaft.

78. A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient, the device comprising an abrasive element mounted to a distal end portion of a rotatable, flexible, hollow drive shaft between a pair of support elements located on the drive shaft distal and proximal to the abrasive element, the distal support element being located at a distal end of the drive shaft and both support elements being spaced away from the abrasive element, the drive shaft having a longitudinal axis and the abrasive element and each of the support elements having their individual centers of mass, the center of mass of the abrasive element being spaced radially away from the longitudinal axis of the drive shaft while the center of mass of the distal support element and the centre of mass of the proximal support element each coincide with the longitudinal axis of the drive shaft.

79. A rotational atherectomy device according to claim 78, wherein the distal support element is fluid inflatable and is in fluid communication with a fluid impermeable guide wire lumen of the drive shaft, said lumen being defined by a fluid impermeable wall of the drive shaft, the distal support element being inflatable by pressurized fluid which flows in an antegrade direction through the fluid impermeable guide wire lumen and is at least partially re-directed into the distal fluid inflatable support element.

80. A rotational atherectomy device according to claim 79, wherein the distal fluid inflatable support element has an outer wall which comprises a plurality of outflow openings located such that said outflow openings face an inner surface of a treated vessel during rotation of the drive shaft, the outflow openings having axes which form angles of about ninety (90) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated, so that in a rotating fluid inflated distal support element flows of fluid through the outflow openings form a layer of fluid between the outer wall of the fluid inflated distal support element and a wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel, the fluid bearing permitting safe rotation and back and forth movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

81. A rotational atherectomy device according to claim 79, wherein the proximal support element is fluid inflatable and is in fluid communication with the fluid impermeable guide wire lumen of the drive shaft, the proximal support element being inflatable by pressurized fluid which flows in the antegrade direction through the fluid impermeable guide wire lumen and is re-directed into the proximal fluid inflatable support element.

82. A rotational atherectomy device according to claim 81, wherein the proximal fluid inflatable support element has an outer wall which comprises a plurality of outflow openings located such that said outflow openings face an inner surface of a treated vessel during rotation of the drive shaft, the outflow openings having axes which form angles of about ninety (90) degrees with the longitudinal axis of the drive shaft when the proximal fluid inflatable support element is inflated, so that in a rotating fluid inflated proximal support element flows of fluid through the outflow openings form a layer of fluid between the outer wall of the fluid inflated proximal support element and a wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated proximal support element and the wall of the treated vessel.

83. A rotational atherectomy device according to claim 80, wherein the proximal support element is solid, the solid proximal support element having a rounded outer surface and a plurality of outflow channels which extend radially outward from the fluid impermeable guide wire lumen of the drive shaft, said outflow channels having outflow openings in the rounded outer surface of the solid proximal support element located such that, during rotation of the drive shaft, said outflow openings on the outer surface of the solid proximal support element are facing an inner surface of the treated vessel, the outflow channels having axes which form angles of about ninety (90) degrees with the longitudinal axis of the drive shaft, so that flows of fluid out of the outflow channels form a layer of fluid between the solid proximal support element and the wall of the treated vessel during rotation of the drive shaft, said layer of fluid forming a fluid bearing between the rotating solid proximal support element and the wall of the treated vessel.