Surgery – Instruments – Blood vessel – duct or teat cutter – scrapper or abrader
Reexamination Certificate
2001-10-24
2004-01-27
Woo, Julian W. (Department: 3731)
Surgery
Instruments
Blood vessel, duct or teat cutter, scrapper or abrader
Reexamination Certificate
active
06682543
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to methods and apparatus for excising mobile and non-mobile atheromatous plaque from the aortic wall and valve and also other arteries such as the carotid arteries and femoral arteries. The devices include an atherectomy catheter system for operation in the aorta, common carotid artery, external and internal carotid arteries, brachiocephalic trunk, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, vertebral artery, basilar artery, subclavian artery, brachial artery, axillary artery, iliac artery, renal artery, femoral artery, popliteal artery, celiac artery, superior mesenteric artery, inferior mesenteric artery, anterior tibial artery, posterior tibial artery and all other arteries carrying oxygenated blood, and the catheter may optionally include blood filter means which enable the capture of plaque inadvertently dislodged during an atherectomy procedure.
BACKGROUND OF THE INVENTION
The importance of the aorta as a source of emboli has only recently become apparent since the advent of transesophageal echocardiography (TEE). This technique has enabled physicians to visualize the aortic wall in great detail and to quantify atheromatous aortic plaque according to thickness, degree of intraluminal protrusion, and presence or absence of mobile components. See Katz et al.,
Journal of the American College of Cardiology
20:70-77 (1992), this and all other references cited herein are expressly incorporated by reference as if set forth herein in their entirety. Anecdotal reports linking embolic events to the presence of mobile aortic atheroma have lead to large-scale studies aimed at establishing the exact relationship between aortic atheromatosis and cerebral embolization. See Flory,
American Journal of Pathology
21:549-565 (1945); Beal et al.,
Neurology
31:860-865 (1981); Soloway et al.,
Archives of Neurology
11:657-667 (1973); Russell et al.,
Stroke
22:253-258 (1991); and Tunick et al.,
Annals of Internal Medicine
114:391-392 (1991).
In 1992, and again in 1994, Amarenco disclosed an unequivocal association between embolic stroke and TEE-detected aortic plaque, especially in the presence of mobile plaque. See Amarenco et al.,
Stroke
23:1005-1009 (1992); and Amarenco et al.,
New England Journal of Medicine
331:1474-1479 (1994). Amarenco performed a prospective, case-control study of the frequency and thickness of atherosclerotic plaques in the ascending aorta and proximal arch in 250 patients with stroke and in 250 controls. Amarenco found protruding plaque (4 mm) in 14.4% of patients with stroke but only 2% of control. Plaques of all thickness were associated with stroke, but the association was strongest for plaques more than 4 mm in thickness. Protruding plaque was present in 28.2% of 78 patients with stroke of unknown cause, compared with 8.1% of 172 patients with stroke of known or likely causes. Furthermore, mobile plaque was present in 7.7% of patients with stroke of unknown cause, compared with only 0.6% of patients with stroke of known cause. The association between protruding atheroma and stroke was strongest for ascending aorta and proximal arch, but weaker for the distal arch and descending aortic disease.
Ulcerated aortic plaque, the pathologic correlate of TEE-detected mobile plaque, was present in autopsies of 26% of 239 patients with cerebrovascular disease as compared with 5% of 261 patients with other neurologic diseases. The prevalence of ulcerated arch lesions was 61% among 28 patients with no known causes of brain infarction, as compared with 22% among 155 patients with a known cause of infarction. See Amarenco et al.,
New England Journal of Medicine
326:221-225 (1992).
Amarenco and others showed prospectively (following patients for two years) a strong correlation between mobile plaque and embolic stroke or emboli to the legs and/or kidneys. In an attempt to investigate the value of aortic atheroma in predicting future vascular events, Tunick followed 42 patients with TEE-detected protruding atheroma and an equal number of controls for up to two years. See Tunick et al.,
Journal of the American College of Cardiology
23:1085-1090 (1994). Fourteen (33%) patients with protruding plaque had 19 embolic events, as compared with 3 out of 42 (7%) controls. These observations have been independently confirmed by a number of other recent studies on risk factors of embolic stroke. See Tunick et al.,
American Heart Journal
120:658-660 (1990), Karalis et al.,
Journal of the American College of Cardiology
17:73-78 (1991), Tunick et al.,
Annals of Internal Medicine
115:423-427 (1991), Tunick et al.,
American Heart Journal
124:239-241 (1992), Horowitz et al.,
Neurology
42:1602-1604 (1992), Toyoda et al.,
Stroke
23:1056-1061 (1992), Nihoyannopoulos et al.,
American Journal of Cardiology
71:1208-1212 (1993), Davila-Roman et al.,
Stroke
25:2010-2016 (1994), and the French Study of Aortic Plaques in Stroke Group,
New England Journal of Medicine
334(19):1216-1221 (1996).
The danger of embolic stroke from atheroma present in the aorta, especially of mobile plaque, has been shown in patients undergoing cardiac surgery, and this effect is due to mechanical manipulations performed on the aorta during cardiac surgery. See Hartman et al.,
Anesthesia Analgesia
1996 (in press), Gold et al.,
Journal of Thoracic Cardiovascular Surgery
110:1302-1314 (1995), Marshall et al.,
Annals of Thoracic Surgery
48:339-344 (1989), Katz et al.,
Journal of American College of Cardiology
20:70-77 (1992); and Hosoda et al.,
Journal of Cardiovascular Surgery
32:301-306 (1991). In fact, among patients undergoing coronary bypass surgery, aortic atheromatosis has emerged as the single most important factor in perioperative neurologic morbidity. See Tunick et al.,
Annals of Internal Medicine
114:391-392 (1991); Karalis et al.,
Journal of the American College of Cardiology
17:73-78 (1991); Marschall et al.,
Journal of Cardiothoracic Vascular Anesthesia
8:5-13 (1994); Blauth et al.,
Journal of Thoracic Cardiovascular Surgery
103:1104-1112 (1992); Wareing et al.,
Journal of Thoracic Cardiovascular Surgery
103:453-462 (1992); Ribakove et al.,
Annals of Thoracic Surgery
53:758-763 (1992); Brillman,
Neurologic Clinics
11:475-495 (1993); and Amarenco et al.,
Stroke
23:1005-1009 (1992). As the number of elderly patients undergoing bypass surgery has increased, the decline in overall mortality and cardiac morbidity achieved by improvements in surgical and anesthetic techniques has been largely obscured by increasing neurologic complication rates. See Loop et al.,
Cleveland Clinical Journal of Medicine
55:23-24 (1988); Hill et al.,
Annals of Thoracic Surgery
7:409-419 (1969); Gardner et al.,
Annals of Thoracic Surgery
40:574-581 (1985); and Cosgrove et al.,
Journal of Thoracic Cardiovascular Surgery
88:673-684 (1984). Aortic atheroma increases sharply with age, from 20% in the fifth decade at necropsy to 80% over the age of 75 years, and stroke rate increases from 1% in patients 51 to 60 years to 7% or more in those over 75 years. See Fisher et al.,
Journal of Neuropathology and Experimental Neurology
24:455-476 (1965); Amarenco et al.,
Stroke
23:1005-1009 (1992); Marschall et al.,
Journal of Cardiothoracic Vascular Anesthesia
8:5-13 (1994); Blauth et al.,
Journal of Thoracic Cardiovascular Surgery
103:1104-1112 (1992); Wareing et al.,
Annals of Thoracic Surgery
55:1400-1408 (1993); and Davila-Roman et al.,
Circulation
84 III-47-III-53, 1991 [suppl 3]; Wareing et al.,
Journal of Thoracic Cardiovascular Surgery
103:453-462 (1992); Gardner et al.,
Annals of Thoracic Surgery
40:574-581 (1985); Cosgrove et al.,
Journal of Thoracic Cardiovascular Surgery
88:673-684 (1984); Davila-Roman et al.,
Stroke
25:2010-2016 (1994); Bar-El et al.,
Journal of Thoracic Cardiovascular Surgery
104:469-474 (1992); and Saloman et al.,
Journal of Thoracic Cardiovascular Surgery
101:209-218 (1991). Among patients dying after coronary bypass surgery, evidence of atheroembo
Barbut Denise R.
Pastrone Giovanni
Root Jonathan D.
C Edwards Lifesciences Corporation
James John Christopher
Nguyen Victor
O'Melveny & Myers LLP
Woo Julian W.
LandOfFree
Methods for aortic artherectomy does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods for aortic artherectomy, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods for aortic artherectomy will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3257548