Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-07-13
2001-07-10
Jaworski, Francis J. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S504000
Reexamination Certificate
active
06258032
ABSTRACT:
BACKGROUND OF THE INVENTION
I. Field of the Invention
This invention deals with medicine and the diagnosis and treatment of certain types of blood vessel diseases and a variety of disorders which all have been discovered to have in common a condition called “Vasospasm” or “Narrowing of the Blood Vessels.”
II. Description of the Prior Art
The most relevant prior art appears to be:
1. Roger P. Woods, Marco Iacoboni, M.D., Ph.D., and John C. Mazziotta, M.D., Ph.D.; Brief Report: Bilateral Spreading Cerebral Hypoperfusion during Spontaneous Migraine Headache. N Engl J Med 1994; 331; 1689-92.
2. M. Hennerici, M.D., W. Rautenberg, M.D., G. Sitzer, M.D., and A. Schwartz, M.D.; Transcranial Doppler Ultrasound for the Assessment of Intracranial Arterial Flow Velocity—Part 1, Examination Technique and Normal Values; Surg Neurol 1987; 27; 439-48.
3. U.S. Pat. No. 5,309,923 to Leuchter and Cook, U.S. Pat. No. 5,307,807 to Sosa et al, U.S. Pat. No. 5,287,859 to Erwin describe “qEEG” devices and techniques useful with the invention.
4. U.S. Pat. No. 5,163,444 to Braverman discusses the P300 brain waves mentioned below.
III. Problems Presented by Prior Art
Prior treatment regimens have generally focused on the acute disease while the present invention embodies the discovery that the vasospasms and vascular narrowings are commonly chronic in nature. Further, past dosages have often been excessive and such over-dosages are found by applicant's investigations to actually be harmful in patients at some stages, because such dosages can themselves subtlety promote vasospasms.
SUMMARY OF THE INVENTION
I. General Statement of the Invention
It is an object of this invention to treat vascular spasm as identified primarily from ultrasound, but which may be suspected on the clinical grounds, with the use of vasodilators in a progressive step-wise fashion, preferably titrated against continuing testing. The introduction usage of the medications and tapering of the medications must be done in a specific fashion in order to result in a clinical improvement of the patient in a variety of conditions which all have in common the presence of vascular spasm. Certain of these conditions have not previously been identified as having vascular spasm as a component of their disorder, and these conditions have been identified in applicant's clinical practice and thus will be named further under the section that deals with claims. It has been recognized that patients with vascular spasm have a typical clinical presentation of symptoms, and that these symptoms follow a progression in substantially direct correlation to the vascular spasm identified on Transcranial Doppler (TCD), a technique using ultrasound imaging of the brain for evaluation of vascular size. It is further recognized clinically that vascular dilation medications may have paradoxical responses depending upon dose. In essence, there is a therapeutic window, a dose which is the proper dose for treatment of the condition which changes over time. Initially under dosing the patient will result in no change of their symptoms, as well as overdosing the patient will result in the exact same symptoms as under dosing the patient or giving the patient no medication at all. Thus vascular dilation medications tend to have a paradoxical response with overdose. The proper dosage for a patient is based upon clinical response in association with objective data as may be identified from Transcranial Doppler ultrasound as well as other imaging modalities.
Essentially the preferred methodology is to obtain an image or measurement of the intracranial blood vessels in the diseased conditions to be noted under claims, and then introduce low dose vasodilation medications. Repeat ultrasounds or other imaging modalities are used to titrate the patient's medical response. As vascular dilatation occurs, medications hen become altered in a stepwise tapering fashion, using ultrasound or other imaging modalities to identify the redevelopment of vasospasm and the appropriate dosage of medication. It is recognized that patients' metabolism may vary across the course of the time that they are on these medications, and it is further recognized that patients' clinical symptoms may not be a useful guide to their response to medication. Accordingly, repeat evaluations with the use of imaging modalities are used to assess pharmacological response.
The invention comprises a method of treating a patient presenting with symptoms suggestive of a stroke or multiple sclerosis (MS) and/or reporting trauma to the neck and/or head e.g. whiplash or concussion from a fall or any other disease discovered to be alleviatable by relaxation of smooth muscle or to comprise vasospasm, preferably intracranial vasospasm as a symptom; comprising in combination:
a) testing by determining rate of blood flow, preferably intercranially or in the arteries of the neck and or upper back, and/or determining relative diameter of those vessels e.g. by magnetic resonance imaging (NMRI) and/or determining evoked potential;
b) treating the patient with an effective dosage of a vasodilator, preferably nitroglycerin administered by patch, preferably at a rate less than about 0.8 mg/hr;
c) re-determining said rate or diameter or potential (collectively “blood flow”) after said treatment, to evaluate recurrence of vasospasm;
d) adjusting the dosage in response to the results of the re-determining;
whereby symptoms comprising headache, burning sensation or pain in the head dizziness, or fainting, etc., or other symptoms of the disease treated, are alleviated.
Disease:
The technique and associated compositions are valuable in the treatment of any condition in which vasospasms, preferably cerebral vasospasms are detected as a component, including without limitation, those conditions listed under Utility of the Invention.
Symptoms:
The common symptom to all these conditions is the vasospasm, particularly cerebral vasospasm.
Testing:
Transcranial Doppler is the most preferred test, both for diagnosis and also for titrating dosage of the vasodilators preferred for treatment. Other tests will preferably be used as discussed under Methodology. Generally intracranial blood velocities greater than 0.6 meters/ second, are indicative of vasospasm. Generalized cerebral vasospasm is identified by TCD Mean Flow Velocities (MFV) of greater than 0. 1, more preferably than 0.3 and particularly greater than 0.4 meters/second in intracranial vessels (about 0.07, 0.2 and 0.4 meters/second, respectively, for vertebrobasilar system) and prolonged diastolic flow component in which continued elevation of diastolic flow beyond end diastolic velocity occurs throughout substantially the entire course of diastole. This prolonged diastole is the most preferred indicator of vasospasm. Other presently available tests which are valuable for vasospasm detection and dosage titration comprise SPECT nuclear medicine testing, angiograms, EEG, qEEG, P300, and other neuropsycological, psychological and electrophysiological tests which can monitor mental impairment due to vasospasm.
Vasodilator:
Nitroglycerine is the most preferred vasodilator for the treatment of the invention, both because of its ready availability in a variety of forms; pill, patch, ointment, cream, spray, inhaler, etc., and because its pharmacology is so well known. The many Nitroglycerine equivalents and substitutes, such as p.o. clonidine, Dynacirc (isradipine), hydrazine, or long acting nifedipine and others known to the art, can be used to replace or to supplement Nitroglycerine. For patients exhibiting Nitroglycerine intolerance, a combination of Nitroglycerine (spray or patch) with Nifedipine is particularly preferred.
Alpha blockers have been tried. Hytrin (Terazosin) has not been found to be effective. Catapress (Clonidine) has been extremely effective. Minipress (Prazosin) has been significantly effective and frequently better tolerated in the long run than Clonidine, although in Applicant's patients, it seems to treat the problem successfully enough to prev
Hammesfahr William M.
Jaworski Francis J.
Willson, Jr. Richard Coale
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