Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
306 words
A method of performing atherectomy on plaque material at a site within a vessel utilizing a directional atherectomy catheter with a cutter which has a marker which is visualizable with fluoroscopy utilizing an X-ray beam, and which may be used to direct cuts; and an ultrasonic imaging apparatus, said method comprising: (a) positioning the catheter cutter with fluoroscopy in the vessel such that the directional marker is perpendicular to the X-ray beam; (b) making an initial reference cut in the plaque material in the vessel; (c) utilizing the ultrasonic imaging apparatus to locate the initial reference cut to orient the distribution of plaque with respect to the visualized position of the fluoroscopically visualizable directional marker on the cutter window so that subsequent cuts made with the cutter result in plaque removal in a first area having a predetermined spatial relationship to the initial reference cut; (d) performing a first series of organized cuts of said plaque in said first area, said series of organized cuts comprising one or more passes with the cutter in said first area; (e) ultrasonically visualizing said vessel to determine the remaining location of plaque after said first series of organized cuts; (f) performing additional cuts in said first area followed by repetition of step (e) until a desired amount of plaque has been removed in said first area; (g) performing cuts of said plaque at an additional chosen area of said site, said additional chosen area having a predetermined spatial relationship to the initial reference cut and to the first series of organized cuts; (h) ultrasonically visualizing said vessel to determine the location of residual plaque after said additional cuts; and (i) performing additional cuts in said additional chosen area followed by repetition of step (h) until a predetermined desired amount of plaque has been removed from said additional chosen area.
Claim 2
Independent Claim
306 words
A method of performing atherectomy on plaque material at a site within a vessel utilizing a directional atherectomy catheter with a cutter which has a marker which is visualizable with fluoroscopy utilizing an X-ray beam, and which may be used to direct cuts; and an ultrasonic imaging apparatus, said method comprising: (a) positioning the catheter cutter with fluoroscopy in the vessel such that the directional marker is perpendicular to the X-ray beam; (b) making an initial reference cut in the plaque material in the vessel; (c) utilizing the ultrasonic imaging apparatus to locate the initial reference cut to orient the distribution of plaque with respect to the visualized position of the fluoroscopically visualizable directional marker on the cutter window so that subsequent cuts made with the cutter result in plaque removal in a first area having a predetermined spatial relationship to the initial reference cut; (d) performing a first series of organized cuts of said plaque in said first area, said series of organized cuts comprising one or more passes with the cutter in said first area; (e) ultrasonically visualizing said vessel to determine the remaining location of plaque after said first series of organized cuts; (f) performing additional cuts in said first area followed by repetition of step (e) until a desired amount of plaque has been removed in said first area; (g) performing cuts of said plaque at an additional chosen area of said site, said additional chosen area having a predetermined spatial relationship to the initial reference cut and to the first series of organized cuts; (h) ultrasonically visualizing said vessel to determine the location of residual plaque after said additional cuts; and (i) performing additional cuts in said additional chosen area followed by repetition of step (h) until a predetermined desired amount of plaque has been removed from said additional chosen area.
Claim 3
Dependent Claim
23 words
The method of claim 1, further comprising repeating steps (g) through (i) until substantially all of the plaque is removed from the site.
Claim 4
Dependent Claim
60 words
The method according to claim 2, wherein said repeating steps (g) through (i) comprises: (a) performing initial additional cuts in a 180° arc centered about the reference cut, with said cuts being done in a first hemicylindrical area; and (b) performing subsequent additional cuts in a second hemicylindrical area of the plaque which is not in the first hemicylindrical area.
Claim 5
Dependent Claim
58 words
The method according to claim 3, wherein said cuts in the first hemicylindrical area are performed first in a 90-degree segment of said plaque on a first side of the reference cut, and later cuts in the first hemicylindrical area are performed in a second 90-degree segment of the plaque on a second side of the reference cut.
Claim 6
Dependent Claim
77 words
The method according to claim 4, wherein cuts in the second hemicylindrical area are performed first in a 90-degree segment of said plaque on a first side of a point on the opposite side of the vessel from the reference cut, and later cuts in the first hemicylindrical area are performed in a second 90-degree segment of the plaque on a second side of the point on the opposite side of the vessel from the reference cut.
Claim 7
Dependent Claim
31 words
The method according to claim 1, further comprising selecting a cutter based on determination of the internal diameter of the vessel utilizing an ultrasonic image of the vessel prior to atherectomy.
Claim 8
Dependent Claim
43 words
A method according to claim 1, wherein the plaque material is thicker on a first side of the vessel lumen than on the remaining sides of said lumen, and wherein said reference cut is made in the plaque material at said first side.
Claim 9
Dependent Claim
36 words
The improved method of claim 1, further comprising utilizing a balloon pressurized at an initial pressure of about 7.5 pounds per square inch to hold the cutter against the plaque material when the cuts are made.
Claim 10
Dependent Claim
141 words
In a method of performing atherectomy on plaque material at a site within a vessel of the type utilizing a directional atherectomy catheter with a cutter which has a marker visualizable on fluoroscopy and which is used to direct cuts, and utilizing an ultrasonic imaging apparatus, the improvement comprising: (a) making an initial reference cut in the plaque material in the vessel; and (b) utilizing the ultrasonic imaging apparatus to locate the initial reference cut to orient the position of the cutter at a first area of plaque having a predetermined spatial relationship to the initial reference cut; and (c) performing one or more of a series of organized cuts of said plaque in said first area; and (d) following each series of organized cuts of said plaque with ultrasonic visualization of the vessel to determine the remaining location of plaque.
Claim 11
Dependent Claim
141 words
In a method of performing atherectomy on plaque material at a site within a vessel of the type utilizing a directional atherectomy catheter with a cutter which has a marker visualizable on fluoroscopy and which is used to direct cuts, and utilizing an ultrasonic imaging apparatus, the improvement comprising: (a) making an initial reference cut in the plaque material in the vessel; and (b) utilizing the ultrasonic imaging apparatus to locate the initial reference cut to orient the position of the cutter at a first area of plaque having a predetermined spatial relationship to the initial reference cut; and (c) performing one or more of a series of organized cuts of said plaque in said first area; and (d) following each series of organized cuts of said plaque with ultrasonic visualization of the vessel to determine the remaining location of plaque.
Claim 12
Dependent Claim
94 words
The improved method of claim 9, further comprising: (a) performing additional removal cuts of plaque material at additional chosen areas of said site in reference to said initial reference cut; (b) ultrasonically visualizing said vessel to determine the location of residual plaque after said additional cuts; (c) performing additional cuts in said additional chosen area followed by repetition of step 10(b) until a predetermined desired amount of plaque has been removed from said additional chosen area; and (d) repeating steps (a) through (c) until substantially all of the plaque is removed from the site.
Claim 13
Dependent Claim
36 words
The improved method of claim 9, further comprising utilizing a balloon pressurized at an initial pressure of about 7.5 pounds per square inch to hold the cutter against the plaque material while the cuts are made.
Claim 14
Dependent Claim
42 words
A method according to claim 9, wherein the plaque material is thicker on a first side of the vessel lumen on the remaining sides of the lumen, and wherein said reference cut is made in the plaque material at said first side.