You know an idea's time has come when someone seeks to patent it.
Dr. Sclafani has been doing exemplary work studying CCSVI, treating patients and sharing his ideas, knowledge and discoveries. Not to mention Dr. Zamboni who "invented" the idea that MS is essentially a vascular pathology. After the FDA created treatment road blocks, CCSVI researchers have been very careful not to say they are treating MS except under tightly controlled conditions. I hope pioneers like Dr. Zamboni and Dr.Sclafani will be well rewarded for their efforts.
Quotes below were taken directly from the Patent Application: (Thanks to mike70)
"United States Patent Application 20120232382 Kind Code A1 Brown; Joe E. ; et al. September 13, 2012
Multiple Sclerosis Diagnostic Devices and Associated Methods and Systems
Abstract
Methods and devices are disclosed that, in various embodiments and permutations and combinations of inventions, diagnose and treat Multiple Sclerosis or associated symptoms. In one series of embodiments, the invention consists of methods and devices for identifying patients whose Multiple Sclerosis or associated symptoms are caused or
exacerbated, at least in part, by blockages of one or more of the patient's internal jugular veins (IJV) or azygous veins (AZV). In some instances, stenoses or other flow limiting structures or lesions in the patient's affected veins are
identified. Further, in some instances the nature of such lesions and whether there is a significant disruption of blood pressure, or both, is ascertained. In some embodiments, methods and devices for applying one or more therapies to the blockages in the patient's IJV or AZV veins are provided.
Inventors:
Brown; Joe E.; (Lilburn, GA) ; Margolis; Marja Pauliina; (Coral Gables, FL) ; Gaddis; Mary L.; (Newport Beach, CA)
Assignee:
Volcano Corporation San Diego CA
Claims
1. A Multiple Sclerosis diagnostic
device comprising: a computing device configured to perform the steps of:
identifying venous outflow obstruction sites; assessing the nature of the
stenotic lesion; and determining the pressure gradient across the stenosis as
compared to the superior vena cava…
…17. A Multiple Sclerosis diagnostic
device comprising: a pressure sensing device sized and shaped for insertion into
a patient's veins; a computing device in communication with the pressure sensing
device, the computing device configured to perform the steps of: identifying
venous outflow obstruction sites; assessing the nature of a stenotic lesion
associated with the venous outflow obstruction sites; and determining a pressure
gradient across the stenosic lesion as compared to the superior vena cava based
on pressure measurements obtained by the pressure sensing device. ..
[0001] This application claims priority to and the benefit
of U.S. Provisional Patent Application No. 61/429,058, filed on Dec. 31, 2010,
which is hereby incorporated by reference in its entirety.
FIELD OF INVENTION
[0002] The present disclosure relates to improved methods and
devices for diagnosing and treating CCSVI (chronic cerebrospinal venous
insufficiency) in patients with multiple sclerosis or other diseases that are
due to or exacerbated by obstructions to blood flow and, more particularly, to
methods and devices for identifying patients particularly likely to benefit from
the delivery of one or more therapies to treat such patients and methods and
devices for delivering such therapies.
BACKGROUND
[0003]
Multiple sclerosis (MS) is an inflammatory disease of the nervous system where
the fatty myelin sheaths around the axons of the brain and spinal column are
damaged. As a result of this damage, the ability of nerve cells in the brain and
spinal cord to communicate with each other is compromised. Almost any
neurological symptom, including physical and cognitive disability, can appear
with the disease. MS affects more than 350,000 people in the United States and
2.5 million worldwide. In the United States, prevalence estimates are
approximately 90 per 100,000 people.
[0004] Beginning with the first
description of the anatomy associated with MS by Jean-Martin Charcot in 1868, MS
plaques associated with MS have been known to be centered or located around
veins. Further, it has been recently shown that MS is significantly correlated
with a condition called chronic cerebrospinal venous insufficiency (CCSVI).
CCSVI is a condition where people have obstructed blood flow in the veins that
drain the central nervous system (the brain and spinal cord) and is
characterized by multiple stenoses of the principal pathways of extracranial
venous drainage, the internal jugular veins (IJV) and the azygous veins (AZV),
with opening of collaterals, clearly demonstrated by means of selective
venography and magnetic resonance venography (MRV).
[0005] Stenosis
literally means a "narrowing." Here "stenosis" or its plural "stenoses" is an
abnormal narrowing of the vein that restricts blood flow. This abnormal
narrowing may be the result of many things. For example, the abnormal narrowing
maybe the result of a collapse of the vein, twisting of the vein, ring-like
narrowings in the vein and other similar obstructions. Further, the abnormal
narrowing may be the result of severe venous problems including veins that are
partially closed, underdeveloped, minimally formed or almost entirely missing.
In addition, an abnormal or defective valve, septum, flap or membrane may
narrow, blocks or inhibit blood flow through the veins. Finally, the build up of
plaque, fibrin or thrombus may cause an abnormal narrowing of the vein. With
respect to MS, a consequence of a stenosis in a vein leads to problems with
normal or efficient blood drainage from the brain and spine back to the heart.
[0006] Intravascular ultrasound ("IVUS") combined with a technique
called virtual histology ("VH") has been particularly successful in recognizing
the morphology of atherosclerotic plaque in vivo (i.e., the location and
composition of plaque in the patient's body). Current developments are underway
to also be able to recognize thrombus in vivo. FIG. 1 illustrates a typical
intravascular imaging system 2 that uses intravascular ultrasound (IVUS). FIG. 2
illustrates a typical intravascular imaging system 2 that uses optical coherence
imaging (OCT).
[0007] An example of an IVUS system is the s51.TM.
Imaging System sold by Volcano Corporation of San Diego, Calif. Examples of OCT
imaging systems include, but are not limited to, those disclosed in U.S. Pat.
No. 5,724,978 issued Mar. 10, 1998 entitled "Enhanced accuracy of
three-dimensional intraluminal ultrasound (ILUS) image reconstruction" with Harm
Tenhoff as inventor, US Published Patent Application Nos. 20070106155 entitled
…,
[0016] In view of the foregoing, what is needed is an effective method
and device for assisting a healthcare provider to identify patients whose MS, or
MS symptoms, are likely exacerbated if not caused, at least in part, by
blockages of one or more of the patient's internal jugular veins (IJV) or
azygous veins (AZV) and for those patients, methods and devices for applying one
or more therapies to the blockages in the patient's IJV or AZV veins.
SUMMARY
[0017] Methods and devices are disclosed that, in various
embodiments and permutations and combinations of inventions, diagnose and treat
MS or MS symptoms. In one series of embodiments, the invention consists of
methods and devices for identifying patients whose MS, or MS symptoms, are
likely exacerbated if not caused, at least in part, by blockages of one or more
of the patient's internal jugular veins (UV) or azygous veins (AZV). In
preferred embodiments of the diagnostic methods, the stenoses in the patient's
affected veins are identified. In other embodiments of the present diagnostic
methods, the nature of such lesions and whether there is a significant
disruption of blood pressure or flow, or both, is ascertained.
[0018] In
another series of embodiments, the invention consists of methods and devices for
applying one or more therapies to the blockages in the patient's IJV or AZV
veins. In preferred embodiments of such methods and devices, therapy is
delivered to open the stenosis causing such blockages.
[0019] It is an
object of this invention in one or more embodiments to identify blockages of a
patient's vasculature or flow limiting or interrupting structures that have
likely exacerbated if not caused, at least in part, MS, or MS symptoms, in that
patient.
[0020] It is an object of this invention in one or more
embodiments to treat blockages of a patient's vasculature or flow limiting or
interrupting structures that have likely exacerbated if not caused, at least in
part, MS, or MS symptoms, in that patient.
DETAILED DESCRIPTION
[0044] The present invention includes several embodiments. In particular,
the present invention includes a Multiple Sclerosis Diagnostic Method 26, its
corresponding Multiple Sclerosis Diagnostic Device 28, a Multiple Sclerosis
Treatment Diagnostic and Treatment Method 30 and its corresponding Multiple
Sclerosis Treatment Diagnostic and Treatment Device 32. The diagnostic method
26 and diagnostic device 28 determine whether a patient's physiology indicates
that the patient has a form of MS, or MS symptoms, that are exacerbated if not
caused, at least in part, by blockages or flow limiting or interrupting
structures of one or more of the patient's internal jugular veins (IJV) or
azygous veins (AZV). The therapeutic method 30 and therapeutic device 32
provide one or more therapies to treat the patient's MS, or MS symptoms. In
embodiments of the invention, the therapeutic method 30 includes a diagnostic
method 26 and, in addition, applies a therapy to treat the MS, or MS symptoms.
In other embodiments of the invention, the therapeutic device 32 includes a
diagnostic device 28 that, in addition, also applies a therapy to treat the MS,
or MS symptoms. Examples of flow limiting or interrupting structures include,
but are not limited to, physiological defects,stenoses and faulty valves…”.
For additional information on this patent application, see: Brown, Joe E.; Margolis, Marja Pauliina; Gaddis, Mary L.
Multiple Sclerosis Diagnostic Devices and Associated Methods and Systems. U.S. Patent Serial Number 340028, filed December 29, 2011, and posted September 20, 2012. Patent URL:
http://appft.uspto.gov/netacgi/nph-Pars ... D/20120913 "
See MS Cure Enigmas.net
.
