DEVICES AND METHODS FOR PERCUTANEOUS ENDARTERECTOMY

• US 20140296889A1
• Filed: 10/04/2012
• Published: 10/02/2014
• Est. Priority Date: 10/04/2011
• Status: Active Grant

• Current Assignee: Angioworks Medical B.V.
• Original Assignee: Angioworks Medical B.V.
• Inventors: Avneri, Ben-Ami, Avneri, Itzhak, Avneri, Shahar, Lore, Rami
• Granted Patent: US 10,149,697 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• 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 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions

Abstract

Devices and methods are provided for percutaneously treating atherosclerotic plaques within blood vessels. Atherosclerotic plaques cause significant morbidity and mortality by narrowing the arteries, which adversely affects blood flow, and by acting as a source for thrombi and emboli thus causing acute organ ischemia. Current treatments include open surgery with its inherent drawbacks, and stenting, which is less invasive but leaves the plaque material in the artery, which promotes restenosis. The present invention combines the advantages of both approaches. In general, the invention provides tools that enable percutaneously dissecting the plaque from the arterial wall and removing it from the body.

Claims

1-66. -66. (canceled)

67. A device for percutaneous endarterectomy, comprising:

a shaft having a lumen and a distal end, a rod disposable in the lumen;

one or more expandable fingers having a proximal and distal end with the proximal end of the one or more fingers attached to the distal end of the shaft, and the one or more expandable fingers having an exterior surface adapted to face an artery and an interior surface adapted to face the rod; and

one or more spokes connecting the rod to the one or more expandable fingers on the interior surface, wherein the one or more expandable fingers are controllable by the rod through the one or more spokes,

wherein the one or more expandable fingers are configured to be adapted to remove an atherosclerotic plaque by peeling the plaque at a subintimal space without performing an incision into the subintimal space and without use of a blade.

68. The device of claim 67, wherein the fingers are configured so that a radial force applied by the fingers decreases from the proximal end to the distal end.

69. The device of claim 67, wherein the fingers further comprise a centerline running longitudinally from the distal end of the fingers to the proximal end of the fingers, wherein the distal end of the fingers, when expanded, is parallel to the shaft, and wherein the fingers are advanceable in one or more of a forward and a backward direction.

70. The device of claim 67, wherein the fingers are radially expandable and rotatable.

71. The device of claim 67, wherein the one or more spokes are disposed in two or more rows and wherein the two or more rows of the one or more spokes connect the rod to the one or more fingers.

72. The device of claim 71, wherein the two or more rows of the one or more spokes are parallel to each other.

73. The device of claim 72, wherein the two or more rows of the one or more spokes create a parallelogram configuration with two sides of the parallelogram configuration formed by the one or more spokes in a pair of the rows, one side formed by the shaft and the other side formed by the one or more fingers.

74. The device of claim 67, wherein a distal tip of the fingers is sharp and wherein the distal end of the fingers is configured to be adapted to find an edge of the plaque without cutting media or adventitia.

75. The device of claim 67, wherein the distal end of the fingers is blunt and configured to be adapted to find an edge of the plaque without cutting media or adventitia.

76. The device of claim 67, further comprising a catheter having a catheter lumen, wherein the shaft is disposable in the catheter lumen.

77. The device of claim 76, wherein the device further comprises a dissector comprising expandable loops configured to be adapted to separate the plaque from an arterial wall around a circumference and along its whole length of the plaque.

78. The device of claim 77, wherein the dissector is configured to be disposable in the catheter lumen.

79. The device of claim 76 further comprising a cutting tool.

80. The device of claim 79, wherein the cutting tool comprises one or more deployable angled blades at a tip of the cutting tool.

81. The device of claim 80, wherein the cutting tool is configured so that the deployable angled blades are adapted to excise the plaque.

82. A device for percutaneous endarterectomy, comprising:

a shaft;

a catheter having a lumen and a distal end for passing over the shaft;

one or more expandable retrograde fingers having a proximal and distal end with the proximal end of the one or more fingers attached to the distal end of the shaft wherein the distal end of the fingers face the proximal end of the catheter; and

a slideable sheath positioned on the distal end of the catheter configured to cover the one or more retrograde fingers,

wherein the retrograde fingers are configured to be adapted to remove an atherosclerotic plaque by peeling the plaque at a subintimal space without performing an incision into the subintimal space and without use of a blade.

83. The device of claim 82, wherein the fingers are self-expandable and the fingers are rotatable.

84. The device of claim 82, wherein the fingers are adapted to remove the plaque by a backward motion.

85. A method of percutaneous endarterectomy, comprising:

(a) accessing an artery having an atherosclerotic plaque with a device comprising;

a shaft configured to pass through a lumen of a catheter, the shaft having a distal end, and

one or more expandable fingers having a proximal and distal end with the proximal end of the one or more fingers attached to the distal end of the shaft,

wherein the distal end of the one or more expandable fingers when expanded is substantially parallel to the shaft; and

(b) utilizing the one or more expandable finger to peel the plaque at a subintimal space without use of one or more of an incision into the subintimal space and a blade.

86. The method of claim 85, further comprising the step of utilizing a cutting tool to cut the intima connecting a distal part of the plaque to the arterial wall.

87. The method of claim 85, further comprising the step of utilizing a dissection tool to separate the plaque, wherein the dissection tool comprises expandable loops adapted to separate the plaque from an arterial wall around a circumference and along the whole length of the plaque.