U.S. patent application number 13/340561 was filed with the patent office on 2012-12-27 for deep vein thrombosis therapeutic methods using therapeutic ablation devices and systems.
This patent application is currently assigned to Volcano Corporation. Invention is credited to Joe E. Brown, Mary L. Gaddis, Marja Pauliina Margolis.
Application Number | 20120330150 13/340561 |
Document ID | / |
Family ID | 46383856 |
Filed Date | 2012-12-27 |
United States Patent
Application |
20120330150 |
Kind Code |
A1 |
Brown; Joe E. ; et
al. |
December 27, 2012 |
Deep Vein Thrombosis Therapeutic Methods Using Therapeutic Ablation
Devices and Systems
Abstract
Methods and devices are disclosed that, in various embodiments
and permutations and combinations of inventions, diagnose and treat
Deep Vein Thrombosis or associated symptoms. In one series of
embodiments, the invention consists of methods and devices for
identifying patients whose Deep Vein Thrombosis or associated
symptoms are caused or exacerbated, at least in part, by blockages
of one or more of the patient's internal peripheral veins. 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 peripheral 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
|
Family ID: |
46383856 |
Appl. No.: |
13/340561 |
Filed: |
December 29, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61429058 |
Dec 31, 2010 |
|
|
|
Current U.S.
Class: |
600/427 ;
600/407; 600/439 |
Current CPC
Class: |
A61M 2025/105 20130101;
A61B 8/12 20130101; A61M 25/104 20130101; A61B 17/320725 20130101;
A61B 18/245 20130101; A61B 18/1492 20130101; G16H 50/30 20180101;
A61B 8/0891 20130101; A61B 8/5246 20130101; A61B 5/0066 20130101;
A61B 6/507 20130101; A61B 8/5223 20130101; A61B 5/02007 20130101;
A61B 8/463 20130101; A61B 2018/0212 20130101; A61B 8/488 20130101;
A61B 2090/3735 20160201; A61M 2025/1052 20130101; A61B 8/06
20130101; A61B 2018/00577 20130101; A61B 2090/3784 20160201; A61B
17/12136 20130101 |
Class at
Publication: |
600/427 ;
600/407; 600/439 |
International
Class: |
A61B 18/24 20060101
A61B018/24; A61B 8/12 20060101 A61B008/12; A61B 18/02 20060101
A61B018/02; A61B 6/02 20060101 A61B006/02; A61B 6/00 20060101
A61B006/00; A61B 18/18 20060101 A61B018/18 |
Claims
1. A method of treating Deep Vein Thrombosis, comprising: providing
a treatment device comprising an ablation catheter capable of
applying ablation chosen from the group of ablation techniques
consisting of laser, RF, cryoablation or other energy sources to
open or enlarge a lumen defined by a stenosis of a vessel wherein
the ablation catheter has a catheter body with a distal end, a
proximal end, a central lumen through which a guide wire may be
passed, an outer surface and ablation system and wherein the
ablation catheter further comprises an imaging transducer as part
of an imaging system located at its distal end; and applying the
treatment device to an indentified venous outflow obstruction site
of a peripheral vein, including visualizing the identified venous
outflow obstruction site with the imaging transducer and ablating
the identified venous outflow obstruction site to increase a
cross-sectional area of a lumen of the peripheral vein.
2. The method of claim 1, wherein the imaging system is an OCT
system having a light source and distal optics and wherein ablation
system is combined with the distal optics of the imaging
system.
3. The method of claim 2, wherein the ablation provided by the
ablation system is laser ablation that is supplied to the ablation
system from the same light source used by the OCT system to produce
the OCT images.
4. The method of claim 2, wherein the provided treatment device
further comprises optical fibers extending along the length of the
catheter connecting the light source to the distal optics.
5. The method of claim 4, wherein the ablation provided by the
ablation system is laser ablation that is supplied to the ablation
system from the same light source used by the OCT system to produce
the OCT images.
6. The method of claim 4, wherein the light source used to produce
the OCT images is located remotely from the distal optics.
7. The method of claim 4, wherein the light source used to produce
the OCT images is located in close proximity to the distal
optics.
8. The method of claim 7, wherein the light source provides the
light needed to produce the OCT images and the laser light used by
the ablation system.
9. The method of claim 1, wherein the imaging transducer is an
ultrasound transducer.
10. The method of claim 9, wherein the ablation catheter utilizes
RF ablation.
11. A Deep Vein Thrombosis therapeutic method comprising: providing
a treatment device that includes: a catheter having a proximal
portion, a distal portion, and a lumen extending along a length of
the catheter between the proximal and distal portions; an ablation
device coupled to the distal portion of the catheter, the ablation
device configured to apply an ablation energy source selected from
the group of ablation techniques consisting of laser, radio
frequency (RF), and cryoablation, the ablation device configured to
open or enlarge a lumen of a vessel constricted by a stenosis; and
an imaging element of an imaging system coupled to the distal
portion of the catheter; and applying the treatment device to an
indentified venous outflow obstruction site of a peripheral vein,
wherein applying the treatment device includes visualizing the
identified venous outflow obstruction site with the imaging element
and ablating the identified venous outflow obstruction site to
increase a cross-sectional area of a lumen of the peripheral
vein.
12. The method of claim 11, wherein the imaging system is an
optical coherence tomography (OCT) system having a light source in
communication with the imaging element, and wherein the ablation
device is combined with the imaging element of the imaging
system.
13. The method of claim 12, wherein the ablation provided by the
ablation system is laser ablation that is supplied to the ablation
device from the same light source used by the OCT system to produce
OCT images.
14. The method of claim 12, wherein the provided treatment device
further comprises at least one optical fiber extending along the
length of the catheter connecting the light source to the imaging
element and ablation device.
15. The method of claim 14, wherein the ablation provided by the
ablation system is laser ablation that is supplied to the ablation
device from the same light source used by the OCT system to produce
OCT images.
16. The method of claim 14, wherein the light source used to
produce the OCT images is located remotely from the imaging
element.
17. The method of claim 14, wherein the light source used to
produce the OCT images is located in close proximity to the imaging
element.
18. The method of claim 17, wherein the light source provides the
light needed to produce the OCT images and the laser light used by
the ablation device.
19. The method of claim 11, wherein the imaging transducer is an
ultrasound transducer.
20. The method of claim 19, wherein the ablation catheter utilizes
RF ablation.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[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 S5i.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 "System and method for
reducing angular geometric distortion in an imaging device" with
John W. Goodnow and Paul Magnin as inventors and published on May
10, 2007, 20080287801 entitled "IMAGING DEVICE IMAGING SYSTEM AND
METHODS OF IMAGING" with Russell W Bowden, Tse Chen Fong, John W.
Goodnow, Paul Magnin and David G. Miller and published on Nov. 20,
2008, 2004693980 entitled "REAL TIME SD-OCT WITH DISTRIBUTED
ACQUISITION AND PROCESSING" with Nathanial J. Kemp, Austin
Broderick McElroy and Joseph P. Piercy as inventors and published
on Apr. 9, 2009, 20080119701 entitled "ANALYTE SENSOR METHOD AND
APPARATUS" with Paul Castella, Nathaniel J. Kemp and Thomas E.
Milner as inventors and published on May 22, 2008, 2004618393
entitled "CATHETER FOR IN VIVO IMAGING" with Larry Dick, Thomas E.
Milner and Daniel D. Sims as inventors and published on Jan. 15,
2009, 2004646295 entitled "APPARATUS AND METHODS FOR UNIFORM SAMPLE
CLOCKING" issued to Nathaniel J. Kemp, Roman Kuranov, Austin
Broderick McElroy and Thomas E. Milner as inventors and published
on Feb. 19, 2009, 2004884749 entitled "OCT Combining Probes and
Integrated Systems" with Dale C. Flanders and Bartley C. Johnson as
inventors and published on Nov. 19, 2009 and WIPO Published Patent
Application No. WO200483635 entitled "FORWARD-IMAGING OPTICAL
COHERENCE TOMOGRAPHY (OCT) SYSTEMS AND PROBE" with Jonathan C.
Condit, Kuman Karthik, Nathaniel J. Kemp, Thomas E. Milner and
Xiaojing Zhang as inventors and published on Feb. 19, 2009, the
collective teachings of which, in their entirety, are incorporated
herein by reference.
[0008] Such imaging systems 2 may also include systems capable of
identifying the makeup of the tissue and material of a patient's
vasculature including so called virtual histology (VH) systems. An
example of a VH system is the S51.TM. Imaging System with VH
capability sold by Volcano Corporation of San Diego, Calif. The
imaging systems 2 may also include systems for measuring the flow
of blood in a patient's vasculature. An example of such a blood
flow measurement system is a color-Doppler ultrasound imaging
system sold under the brand name of Chromaflow.RTM. by Volcano
Corporation of San Diego Calif.
[0009] In an exemplary imaging system 2, an intra-vascular
ultrasound (IVUS) console 4 is electrically connected to an IVUS
catheter 6 and used to acquire RF backscattered data (i.e., IVUS
data) from a blood vessel. The IVUS console 4 typically includes a
computing device 8 comprising a database 10 and a characterization
application 12 electrically connected to the database 10 and
adapted to receive IVUS data from the IVUS console 4 or directly
from a transducer 14. Specifically, a transducer 14 is attached to
the end of the catheter 6 and is carefully maneuvered through a
patient's arteries to a point of interest along the artery. The
transducer is then pulsed to acquire high-frequency sonic echoes or
backscattered signals reflected from the tissue of the vascular
object. Because different types and densities of tissue absorb and
reflect the ultrasound pulse differently, the reflected data (i.e.,
IVUS data) is used to image the vascular object. In other words,
the IVUS data can be used (e.g., by the IVUS console 4 or a
separate computing device 8) to create an IVUS image.
[0010] An exemplary IVUS image 16 is shown in FIG. 2, where the
light and dark regions indicate different tissue types and/or
densities. It should be appreciated that the IVUS console 4
depicted herein is not limited to any particular type of IVUS
console, and includes all ultrasonic devices known to those skilled
in the art (e.g., a Revolution.RTM. or EagleEye.RTM. IVUS catheter
used in conjunction with an S5.TM. IVUS imaging system, all of
which are sold by Volcano Corporation of San Diego, Calif.). It
should further be appreciated that the IVUS catheter 6 depicted
herein is not limited to any particular type of catheter, and
includes all ultrasonic catheters known to those skilled in the
art. Thus, for example, a catheter having a single transducer
(e.g., adapted for rotation) or an array of transducers (e.g.,
circumferentially positioned around the catheter or longitudinally
along the catheter 6) can be used with the typical imaging system
2.
[0011] It should be appreciated that the database 10 depicted
herein includes, but is not limited to, RAM, cache memory, flash
memory, magnetic disks, optical disks, removable disks, SCSI disks,
IDE hard drives, tape drives and all other types of data storage
devices (and combinations thereof, such as RAID devices) generally
known to those skilled in the art. It should further be appreciated
that the characterization application 12, as depicted and discussed
herein, may exist as a single application or as multiple
applications, locally and/or remotely stored. It should also be
appreciated that the number and location of the components depicted
in FIG. 1 do not limit a typical imaging system 2 but are merely
provided to illustrate a typical imaging system 2. Thus, for
example, a computing device 8 having a plurality of databases 10 or
a remotely located characterization application 12 (either in part
or in whole) or any combination of these may also be found in a
typical imaging system 2.
[0012] In one embodiment of a typical imaging system 2, the
characterization application 12 is adapted to receive and store
characterization data (e.g., tissue type, etc.). The
characterization data was determined prior to using the
tissue--characterization system 2 as follows. After a specimen
vascular object has been interrogated (e.g., IVUS data has been
collected), a histology correlation is prepared. In other words,
the specimen vascular object is dissected or cross-sectioned for
histology. In one method of producing characterization data, the
cross-section is previously marked, for example with a suture, so
that the histology can be corresponded to a portion of the IVUS
image. The cross-section is then prepared with a fixing and
staining process that is well known in the art. The staining
process allows a clinician to identify a tissue type(s), or a
chemical(s) found within (e.g., a chemical corresponding to a
particular tissue type, etc.). The identified tissue type or types
is then correlated to the IVUS data as will be explained below.
[0013] Where the imaging system 2 is or includes an OCT system, the
imaging system 2 typically includes a light source 20 that produces
light of a desired frequency and with other desired characteristics
well understood in the art that is ultimately directed from the
catheter 6 to the patient's vasculature by distal optics 22. A
typical OCT imaging system 2 has the light source 20 located
remotely from or nearby the catheter 6. Optical fibers 24 carry the
light from the light source 20 to the distal optics 22.
[0014] It should be appreciated that there may be many methods used
to identify or characterize the cross-sectional object as is well
understood in the art besides the method just described. Thus, any
identification/characterization method generally known to those
skilled in the art may be used to characterize tissue. The
identified tissue type or characterization (i.e., characterization
data) is then provided to the characterization application 12. In
one embodiment, as shown in FIG. 1, the characterization data is
provided via an input device 18 electrically connected to the
computing device 8. The characterization data is preferably then
stored in the database 10. It should be appreciated that the input
device depicted herein includes, but is not limited to, a keyboard,
a mouse, a scanner and all other data-gathering and/or data-entry
devices generally known to those skilled in the art. It should
further be appreciated that the term tissue type or
characterization, as these terms are used herein, include, but are
not limited to, fibrous tissues, fibro-lipidic tissues, calcified
necrotic tissues, necrotic core, calcific tissues, collagen
compositions, cholesterol, thrombus, compositional structures
(e.g., the lumen, the vessel wall, the medial-adventitial boundary,
etc.) and all other identifiable characteristics generally known to
those skilled in the art.
[0015] In one method of characterizing tissue, the characterization
application is adapted to create a histology image and to identify
at least one corresponding region on an IVUS image. Specifically,
digitized data is provided to the characterization application
(e.g., via the input device 18), where the digitized data
corresponds to the cross-sectioned vascular object. The digitized
data is then used to create a histology image (i.e., a digital
image or outline that substantially corresponds to the vascular
object). A region of interest (ROI) on the histology image can then
be identified by the operator. Preferably, the ROI is characterized
by the characterization data, as previously provided, and may be
the entire histology image or a portion thereof. The
characterization application is then adapted to identify a
corresponding region (e.g., x,y coordinates, etc.) on the IVUS
image.
[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.
[0021] The invention will be described hereafter in detail with
particular reference to the drawings. Throughout this description,
like elements, in whatever embodiment described, refer to common
elements wherever referred to and referenced by the same reference
number. The characteristics, attributes, functions, interrelations
ascribed to a particular element in one location apply to that
element when referred to by the same reference number in another
location unless specifically stated otherwise.
BRIEF DESCRIPTIONS OF THE DRAWINGS
[0022] FIG. 1 is a schematic view of a typical intravascular
ultrasound (IVUS) imaging system.
[0023] FIG. 2 is a schematic view of a typical intravascular
optical coherence tomography (OCT) imaging system.
[0024] FIG. 3 is a flow chart of an embodiment of the diagnostic
method of the present invention.
[0025] FIG. 4 is a flow chart of another embodiment of the
diagnostic method of the present invention.
[0026] FIG. 5 is a flow chart of another embodiment of the
diagnostic method of the present invention.
[0027] FIG. 6 is a flow chart of another embodiment of the
diagnostic method of the present invention.
[0028] FIG. 7 is a schematic view of an embodiment of the
diagnostic device of the present invention.
[0029] FIG. 8 is a flow chart of an embodiment of the therapeutic
method of the present invention.
[0030] FIG. 9 is a flow chart of an alternate embodiment of the
therapeutic method of the present invention.
[0031] FIG. 10 is a flow chart of an embodiment of the therapy
delivered as the therapeutic method of the present invention.
[0032] FIG. 11 is a side cross-sectional schematic view of a device
of a therapy that could be applied as the therapy of the any of the
therapeutic methods of the present invention.
[0033] FIG. 12 is a side cross-sectional schematic view of a device
of a therapy that could be applied as the therapy of the any of the
therapeutic methods of the present invention.
[0034] FIG. 13 is an end schematic view of the device of FIG.
12.
[0035] FIG. 14 is a side cross-sectional schematic view of a device
of a therapy that could be applied as the therapy of the any of the
therapeutic methods of the present invention.
[0036] FIG. 15 is a side cross-sectional schematic view of an
alternate embodiment of the device of FIG. 14.
[0037] FIG. 16 is a side cross-sectional schematic view of a device
of a therapy that could be applied as the therapy of the any of the
therapeutic methods of the present invention.
[0038] FIG. 17 is a schematic view of an embodiment of the
therapeutic device of the present invention.
[0039] FIG. 18 is a flow chart of another embodiment of the
therapeutic method of the present invention.
[0040] FIG. 19 is a flow chart of another embodiment of the
therapeutic method of the present invention.
[0041] FIG. 20 is a flow chart of another embodiment of the
therapeutic method of the present invention.
[0042] FIG. 21 is a flow chart of another embodiment of the
therapeutic method of the present invention.
[0043] FIG. 22 is a flow chart of another embodiment of the
therapeutic method of the present invention.
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.
[0045] Referring to the Figures, the diagnostic method is shown in
the Figures generally referred to by the reference number 26. The
diagnostic method 26, in preferred embodiments described hereafter,
acts according to algorithms having the following steps, as set out
in the flow charts of FIGS. 3-6.
[0046] In the diagnostic method 26 shown in FIG. 3, the diagnostic
method begins at step 36 where venous outflow obstruction sites are
identified. A preferred method of identifying these obstruction
sites is by sequentially accessing the AZV entry into the superior
vena cava and the two Common Jugular veins by selective venography
at each of these sites to confirm or exclude a significant stenosis
or flow disruption. Venography, which is also called phlebography,
involves taking an x-ray of the veins, a venogram, after a special
dye is injected via a catheter into the vein of interest.
Typically, the dye is injected constantly via a catheter. As a
result, a venography is an invasive procedure.
[0047] Although venography has been a preferred method for
selecting sites having significant stenosis or flow disruption,
ultrasonography, including duplex ultrasonography, could also be
used in the alternative or in addition to identify obstructed
outflow sites.
Ultrasonography Incorporates Two Elements:
[0048] 1) Grayscale Ultrasound (e.g., from an IVUS imaging system
2) is used to visualize the structure or architecture of the vein
to identify stenoses (cross-sectional narrowing of the vein);
[0049] 2) Color-Doppler ultrasound imaging (e.g., from Volcano
Corporation) is then used to visualize the flow or movement of a
blood within the vein;
[0050] and typically presents both displays on the same screen
("duplex") to facilitate interpretation. Where ultrasonography is
used, a stenosis having cross-sectional narrowing greater than
about 70% is considered worthy of treatment as are blood flow
velocities greater than 250 cm/sec (which also indicate a region of
narrowing or resistance produced by a major stenosis).
Ultrasonography can also be enhanced by tissue characterization
such as the virtual histology characterization described above, for
example, as part of the S5i.TM. Imaging System with VH capability
sold by Volcano Corporation of San Diego, Calif.
[0051] Besides venography and ultrasonography, transcutaneous
echography applied to an accessible section of the IJV could also
be used to identify venous outflow obstruction sites and to confirm
or exclude a significant stenosis or flow disruption at those
sites. Further, in an embodiment of the invention, radionuclides
that bind to proteins specific to fibrin, such as radionuclides
bound to insulin-like growth factor (IGF) binding proteins (IGFBPs)
are applied intravenously, preferably near where an obstruction is
believed to be located, or orally. Then, external detectors such as
gamma cameras capture and form images from the detected radiation
emitted by the radionuclides that are bound to the proteins of the
fibrin. This allows the areas of venous outflow obstruction caused
by the buildup of thrombus to be located and to confirm or exclude
a significant stenosis or flow disruption at the site. These last
two methods have the desirable characteristic of being
non-invasive.
[0052] In a modification of the invention above where something is
bound to proteins specific to fibrin, plasmin, other plasmids or
any like substance that dissolves fibrin is bound to the same IGFBP
that contains the radionuclide or to an entirely different IGFBP
and then delivered to the site of the fibrin as described above.
The plasmin, plasmid or other substance that dissolves fibrin in
whatever form may be self-activated (i.e., it is active upon
delivery) or may be activated by the exposure to either a specific
light frequency or by ultrasound at a specific frequency or any
like energy source delivered either intravascularly or
noninvasively. Where these substances are active by a specific
light frequency or by ultrasound at a specific frequency, the light
or ultrasound or both may be delivered via the distal optics 22 or
transducer 14, respectively.
[0053] Once the venous outflow obstruction sites have been
identified by whatever method, the method passes to step 38. In
step 38, the nature of the stenotic lesion is assessed. This
assessment is preferably accomplished by applying an imaging system
2 such as an IVUS or OCT system or a system having both IVUS and
OCT or applying both IVUS and OCT imaging to suspected areas of
narrowing or flow disruption to identify intraluminal abnormalities
including webs, flaps, inverted or incompetent valves and membranes
as well as stenoses caused by plaque or the buildup of fibrin or
thrombus. Here, a significant stenosis, of whatever kind, is
defined as luminal reduction greater than 50% of the normal venous
diameter near the stenosis as obtained during step 36 or a
significant flow disruption associated with an intraluminal
abnormality noted during the IVUS or OCT imaging of this step 38.
Both IVUS and OCT will provide vessel information whereby vessel
circumference measurements can be made. This will allow the
physician to check the lumen narrowing to determine whether such
narrowing is significant as defined above (i.e., cross-sectional
narrowing greater than about 70% or blood flow velocities greater
than 250 cm/sec). In a preferred embodiment of the invention,
software is provided on the imaging system 2 to correlate these
measurements. Once IVUS or OCT or both IVUS and OCT has been used
to assess the nature of the stenotic lesion, the method passes to
step 40.
[0054] In step 40, the pressure gradient across the stenosis (as
compared to the superior vena cava) is determined. This pressure
gradient is preferably determined using either a manometer,
pressure wire or any other blood pressure measuring device if the
suspected significant venous stenosis/intraluminal abnormality is
confirmed by any of the methods of step 38. Examples of pressure
wires are the PrimeWire PRESTIGE.TM. guide wire, PrimeWire.RTM.
guide wire and the ComboWire.RTM. XT guide wire all made and sold
by Volcano Corporation of San Diego, Calif. A pressure gradient
larger than 1-2 mm Hg may indicate the presence of a significant
stenosis. Information on the pressure gradient is preferably but
not required to be communicated to the healthcare provider. The
communication in this step 40 may take the form of a message
displayed on console 4, the modifying of an image of a vascular
structure displayed on the console 4 such as by appending a text or
color indicator that the patient's physiology at that location on
the vessel is such that the patient's pressure gradient exceeds the
targeted amount, the communication of the parameter values
themselves separately or by any other means well within the skill
of one skilled in the art to communicate such values.
[0055] In the diagnostic method 26 described above, the listed
steps 36-40 were performed in the order given. However, it is
within the scope of the invention for steps 38 and 40 to be
reversed. In this embodiment of the invention shown in FIG. 4, the
diagnostic method 26 has the form of the steps above performed in
the following sequential order:
[0056] Step 36: Indentify venous outflow obstruction sites;
[0057] Step 40: Determine pressure gradient across the stenosis;
and
[0058] Step 38: Assess the nature of the stenotic lesion.
[0059] Further, in another embodiment of the diagnostic method 26,
the method shown in FIG. 3 could be simplified so that either step
38 or step 40 is done without doing the other so that the method
takes the following forms, shown in FIGS. 5 and 6, respectively, of
the steps above performed in the following sequential order:
[0060] Step 36: Indentify venous outflow obstruction sites; and
[0061] Step 38: Assess the nature of the stenotic lesion. and,
[0062] Step 36: Indentify venous outflow obstruction sites; and
[0063] Step 40: Determine pressure gradient across the
stenosis.
[0064] As mentioned above, the diagnostic method 26 in all forms
assesses whether a patient has a form of MS, or MS symptoms, that
are likely amenable to treatment by a therapy that is directed to
the stenosis in the patient's vein and, as a result, has diagnostic
value as a diagnostic tool. This diagnostic value occurs in all the
embodiments of the diagnostic method 26 described above.
[0065] The diagnostic method 26 is typically run as software on a
computing device 8 and thus the combination of the computing device
8 and the diagnostic methods 20, as described above, becomes the
diagnostic device 28. FIG. 7 shows an embodiment of the diagnostic
device 28 where the steps 36-38 are performed on the computing
device 8. Although the diagnostic device 28 is preferably operated
on a computing device 8, the diagnostic device 28 may also be
operated separately on any system having sufficient computing
capability to perform the steps of the diagnostic method 26 and be
operatively connected to the console 4, computing device 8,
characterization application 12 or database 10 or any combination
of these. In addition, the diagnostic device 28 may also be an
application specific device or hardwired specifically to perform
the functions described herein.
[0066] The diagnostic device 28, in preferred embodiments, acts
according to algorithms described above in connection with the
diagnostic method 26. The diagnostic device 28 may be implemented
on or may be an adjunct to an imaging system 2. The imaging system
2 may take the form of an intravascular ultrasound (IVUS) imaging
system 2 as described above including a console 4, IVUS catheter 6,
a computing device 8 comprising a database 10 and a
characterization application 12 electrically connected to the
database 10 and typically run on the computing device 8.
Alternately or in addition, the imaging system 2 may take the form
of an optical coherence tomography (OCT) system that also includes
a console 4, OCT catheter 6, a computing device 8 comprising a
database 10 and a characterization application 12 electrically
connected to the database 10 and typically run on the computing
device 8.
[0067] Although IVUS and OCT systems singly or in combination have
been described as the imaging system 2, any imaging system that
obtains images of the patient's vascular may be used. Such
alternate imaging systems 2 will also typically include a console
4, a catheter 6 appropriate for that imaging system 2, a computing
device 8 comprising a database 10 and a characterization
application 12 electrically connected to the database 10 and
typically run on the computing device 8. Regardless of the imaging
system 2, the diagnostic device 28 is adapted to communicate, that
is both receive and transmit data and information, with the console
4 or the computing device 8.
[0068] Where it has been determined that a patient has a form of
MS, or MS symptoms, that are likely amenable to treatment by a
therapy that is directed to the stenosis in the patient's vein, it
is also desirable to have a tool that, under the physician's
control, directs a desired therapy to the stenosis. The therapeutic
method 30 and its corresponding therapeutic device 32, as described
hereafter, is such a tool.
[0069] In one embodiment of the therapeutic method 30 shown in FIG.
8, the diagnostic method 26 is included as a diagnostic precursor
to applying a desired therapy. So, the therapeutic method 30 in a
preferred embodiment includes a diagnostic method 26 that operates
as described above in all the variants of diagnostic method 26. In
another embodiment of the therapeutic method 30 shown in FIG. 9,
the therapeutic method 30 does not include a diagnostic method 26
but includes only the delivery of a therapy 42 as will be described
hereafter.
[0070] In the embodiment of the therapeutic method 30 of FIG. 8
including a diagnostic method 26, after the diagnostic steps have
been accomplished and it has been determined that 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 of one or more of the patient's internal jugular veins
(IJV) or azygous veins (AZV), the program passes to step 42. In
step 42, a desired therapy is applied to treat the stenotic lesion.
The therapy applied is preferably one that, as a result of the
application of the therapy, produces a reduction of the stenosis
such that the residual stenosis no longer is flow limiting or that
a pressure gradient exceeding 1-2 mm Hg is no longer observed or
both.
[0071] In one embodiment of the therapeutic method 30, a preferred
therapy in step 42 is angioplasty to open or enlarge the troubling
stenosis. The angioplasty may be either conventional angioplasty or
angioplasty using a cutting or scoring balloon. FIG. 10 shows a
flow chart of the steps involved in the therapeutic method 30 to
accomplish such an angioplasty procedure. The goal of the
angioplasty procedure will be to restore the venous outflow
structure to where it is no longer flow limiting, flow disruption
is resolved and pressure gradient is minimal.
[0072] In FIG. 10, the angioplasty therapy is begun at step 44
where the appropriate angioplasty balloon to be used is determined
based on measurements previously made such as during a venogram. It
is preferable but not required for the balloon to be a
non-compliant balloon that will have a nominal inflated diameter of
at least 80% of the normal proximal non-stenosed vein. The benefit
of using a non-compliant balloon here is to obtain high pressure to
increase the opportunity for compression of the obstruction.
[0073] The balloon is preferably a one piece balloon. Such a
balloon may, but is not required to be, coated with or exuding a
drug such as tissue plasminogen activator, urokinase,
streptokinase, collagenace, hepranoids and any other fibrinolytic
or direct anti-thrombin drug or drugs or antigens or both that may
promote more rapid healing of a vessel.
[0074] Further, as mentioned above, the balloon may be a cutting or
scoring balloon. A cutting balloon is one that has small blades
that are activated (moved outward) by actuation of the balloon. The
cutting blades score the fibrin of a lesion, particularly thrombus
that is attached to and incorporated into the vein wall, thereby
creating space that allows the rest of the fibrin to be compressed
into a larger opening by the opening of the balloon. When the
appropriate balloon to be used to open the stenosis has been
determined, by whatever means, the program then passes to step 46.
The scoring balloon is one that scores the plaque circumferentially
to dilate the obstructed vessel such as the AngioSculpt Scoring
Balloon Catheter made and sold by AngioScore Inc. of Fremont,
Calif.
[0075] At step 46, the patient is loaded with intravenous weight
based load of heparin (50-100 U/kg) to confirm an Activated
Clotting Time (ACT) of at least 250 as is well understood in the
art. After loading the patient with heparin to confirm ACT, the
program then passes to step 48.
[0076] In step 48, the balloon is placed at the stenosis and
inflated as is well understood in the art. After confirmation of
the ACT, an exchange length 0.035'' exchange length glide wire is
advanced into the proximal vein of interest (before the
obstruction) and the non-compliant balloon is placed across the
stenosis. The balloon is slowly inflated, for example, with one
atmosphere per 30 seconds until reaching nominal pressure (e.g.,
8-12 atmospheres) to open the stenosis. The dilated balloon is left
in place for a clinically significant time as is well understood in
the art. After the balloon has been left in place for a clinically
significant time, the method then passes to step 50.
[0077] In step 50, the balloon is deflated and withdrawn. The
balloon is preferably deflated at a moderate rate (e.g., one
atmosphere per 15 seconds) and then withdrawn from the patient's
vascular by techniques well understood in the art.
[0078] FIG. 11 shows a device of another therapy that could be
applied as the therapy in step 42. In this embodiment of the
therapeutic method 30, an occlusive balloon is shown generally
labeled 46. The balloon catheter 52 has a catheter body 54 with a
distal end 56, an ultimate distal end 58, a proximal end 60, a
central lumen 62, a balloon 64 and a balloon lumen 66. The balloon
64 is located a small distance from the ultimate distal end 58 and
the central lumen 62 extends from the proximal end of the balloon
catheter 52 to the ultimate distal end 58.
[0079] The balloon catheter 52 also has an imaging transducer 14
located at the distal end 56 of the balloon catheter 52. The
imaging transducer 14 is preferably an IVUS or OCT imaging
transducer that is part of an imaging system 2 such as has been
described above that allows the user to identify intravascular
stenoses. The imaging system 2 may also include so-called virtual
histology (VH) technology to help the physician recognize and
identify the morphology of tissue, particularly plaque associated
with a lesion, in vivo (i.e., the location and composition of
plaque in the patient's body). The following systems for detecting
and characterizing plaque using IVUS with VH are disclosed in U.S.
Pat. Nos. 6,200,268 entitled "VASCULAR PLAQUE CHARACTERIZATION"
issued Mar. 13, 2001 with D. Geoffrey Vince, Barry D. Kuban and
Anuja Nair as inventors, 6,381,350 entitled "INTRAVASCULAR
ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM" issued
Apr. 30, 2002 with Jon D. Klingensmith, D. Geoffrey Vince and Raj
Shekhar as inventors, 7,074,188 entitled "SYSTEM AND METHOD OF
CHARACTERIZING VASCULAR TISSUE" issued Jul. 11, 2006 with Anuja
Nair, D. Geoffrey Vince, Jon D. Klingensmith and Barry D. Kuban as
inventors, 7,175,597 entitled "NON-INVASIVE TISSUE CHARACTERIZATION
SYSTEM AND METHOD" issued Feb. 13, 2007 with D. Geoffrey Vince,
Anuja Nair and Jon D. Klingensmith as inventors, 7,215,802 entitled
"SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION" issued May 8,
2007 with Jon D. Klingensmith, Anuja Nair, Barry D. Kuban and D.
Geoffrey Vince as inventors, 7,359,554 entitled "SYSTEM AND METHOD
FOR IDENTIFYING A VASCULAR BORDER" issued Apr. 15, 2008 with Jon D.
Klingensmith, D. Geoffrey Vince, Anuja Nair and Barry D. Kuban as
inventors and 7,463,759 entitled "SYSTEM AND METHOD FOR VASCULAR
BORDER DETECTION" issued Dec. 9, 2008 with Jon D. Klingensmith,
Anuja Nair, Barry D. Kuban and D. Geoffrey Vince, as inventors, the
teachings of which are hereby incorporated by reference herein in
their entirety.
[0080] In one embodiment of the present invention, a
characterization application of the IVUS system is adapted to
receive and store venous characterization data (e.g., tissue type,
etc.) that is subsequently utilized to classify the tissue type of
a patient. For example, after a venous vessel has been interrogated
(e.g., IVUS data has been collected), a histology correlation is
prepared. In other words, the venous vessel is dissected or
cross-sectioned for histology. In one embodiment of the present
invention, the cross-section is marked, for example with one or
more sutures, so that the histology can be correlated to a portion
of the IVUS image based on the marker(s). The cross-section is then
prepared with a fixing and staining process that is well known in
the art. The staining process allows a trained clinician to
identify a tissue type(s), or a chemical(s) found within (e.g., a
chemical corresponding to a particular tissue type, etc.). It
should be appreciated that the particular method used to identify
or characterize the cross-sectional venous vessel is not a
limitation of the present invention. Thus, all
identification/characterization methods generally known to those
skilled in the art are within the spirit and scope of the present
invention.
[0081] The identified tissue type or characterization (i.e.,
characterization data) is then provided to the characterization
application for storage and access in future procedures.
Accordingly, in some instances the characterization data is stored
in a venous tissue characteristic database. It should be
appreciated that the data may input to the characterization
application and/or database using any suitable input device(s)
generally known to those skilled in the art. It should further be
appreciated that the term tissue type or characterization, as these
terms are used herein, include, but are not limited to, fibrous
tissues, fibro-lipidic tissues, calcified necrotic tissues,
calcific tissues, collagen compositions, cholesterol, thrombus,
compositional structures (e.g., the lumen, the vessel wall, the
medial-adventitial boundary, etc.) and all other identifiable
characteristics generally known to those skilled in the art.
[0082] One method of populating the venous tissue characteristic
database begins with collecting IVUS data (i.e., RF backscatter
data) from a portion of a venous vessel. This data is then used to
create an IVUS image at step. The interrogated portion of the
venous vessel is cross-sectioned and a tissue type (or a
characterization thereof) is identified. This information (i.e.,
characterization data) is then transmitted to a computing device
(or the equivalent thereof). An image of the cross-sectioned
vascular object is created and at least one region of interest is
identified (e.g., by an operator). This image is then morphed, if
needed, to substantially match it to the initially obtained IVUS
image. This may include identifying at least one landmark and
applying at least one algorithm (e.g., a morphometric algorithm, a
thin plate spline deformation technique, etc.). The region(s) of
interest is mapped to the IVUS image and associated IVUS data is
identified. Spectral analysis is then performed on the associated
IVUS data, and at least one parameter is identified. The at least
one parameter and the characterization data are then stored in the
database. In one embodiment of the present invention, the at least
one parameter is stored such that it is linked to the
characterization data. It should be appreciated that the order in
which these steps are presented is not intended to limit the
present invention. Thus, for example, creating an IVUS image after
the vascular object is cross-sectioned is within the spirit and
scope of the present invention.
[0083] The above-described process is repeated for each tissue
component desired to be identified and repeated for each component
as many times as desired in order to obtain a more accurate range
of signal properties. With the database populated, a tissue type or
characteristic can be automatically and accurately identified if
the acquired parameters substantially match parameters stored in
the database. With the venous tissue characteristic database
populated, the characterization application of the IVUS system can
then be utilized to receive IVUS data, determine parameters related
thereto, and use the venous tissue characteristic parameters stored
in the database (i.e., histology data) to identify tissue type(s)
or characterization(s) thereof.
[0084] The central lumen 62 of the balloon catheter 52 is attached
to a source of suction (not shown) at the proximal end 60 of the
balloon catheter 52 by means well understood in the art. The distal
end 56 of the balloon catheter 52 is advanced in the patient's vein
of interest past the lesion but where the balloon 64 is downstream
of the lesion. The balloon 64 is inflated so that it occludes blood
flow in the vein. In this configuration, the ultimate distal end 58
is located near the lesion. The suction is activates so that
suction is applied at the ultimate distal end 58. Because the
ultimate distal end 58 is located in close proximity of the lesion,
thrombus will be subject to the suction force and sucked into the
balloon catheter to travel through the central lumen 62 to be
removed through the proximal end 60.
[0085] Another embodiment of a device of another therapy that could
be applied as the therapy in step 42 is shown in FIGS. 12 and 13.
In this embodiment, a cutting catheter 68 is shown. The cutting
catheter 68 has a catheter body 70 with a distal end 72, a proximal
end 74, a central lumen 76 through which a guide wire (not shown)
may be passed and an outer surface 78. The cutting catheter 68
includes, but is not limited to, the types disclosed in U.S. Pat.
Nos. 5,421,338 entitled "Acoustic Imaging Catheter and the Like"
issued to Robert J. Crowley, Mark A. Hamm and Charles D. Lennox on
Jun. 6, 1995; 6,283,921 entitled "Ultrasonic Visualization and
Catheters Therefor" issued to Elvin Leonard Nix, Amit Kumar Som,
Martin Terry Rothman and Andrew Robert Pacey on Sep. 4, 2001;
5,800,450 entitled "Neovascularization Catheter` issued to Banning
Gray Lary and Herbert R. Radisch, Jr. on Sep. 1, 1998; 5,507,761
and 5,512,044 both entitled "Embolic Cutting Catheter" issued to
Edward Y. Duer on Apr. 16, 1996 and Apr. 30, 1996, respectively;
5,925,055 entitled "Multimodal Rotary Abrasion and Acoustic
Ablation Catheter" issued to Sorin Adrian and Paul Walinsky on Jul.
20, 1999; 4,917,085 entitled "Drive Cutting Catheter Having a New
and Improved Motor" issued to Kevin W. Smith on Apr. 17, 1990 and
US Published Patent Application No. 2006111704 entitled "Devices,
Systems, and Methods for Energy Assisted Arterio-venous Fistula
Creation" filed by Rodney Brenneman, Dean A. Schaefer and J.
Christopher Flaherty on Nov. 16, 2005, the teachings of which are
incorporated herein in their entirety by reference.
[0086] The cutting catheter 68 preferably has an imaging transducer
14 as part of an imaging system 2 located at its distal end 72.
Further, the cutting catheter 68 includes cutting blades 80 located
on its outer surface 78 near the distal end 72. The cutting blades
80 are preferably anywhere from about 0.5-2 mm in depth and from
about 5-20 mm in length although other lengths can be used
depending on the vessel that the cutting catheter 68 will be used
in. The cutting blades 80 can be spaced radially around the outer
surface 78 for cutting or scoring circumferentially or can be
spaced on one side of the catheter 68 for selective cutting or
scoring. When the catheter 68 is pulled back during an imaging
procedure, the cutting blades 80 contact and score the fibrin of
the lesion, particularly thrombus that is attached to and
incorporated into the vein wall, thereby creating space that allows
the rest of the fibrin to be compressed into a larger opening by
the opening of the balloon.
[0087] Yet another embodiment of a device of another therapy that
could be applied as the therapy in step 42 is shown in FIG. 14. In
this embodiment, an ablation catheter 82 is shown. Such ablation
catheter 82 delivers ablation energy through laser, so-called Radio
Frequency Ablation or "RFA", both ablative and thermal,
cryoablation, ultrasound, microwave or other energy sources.
Examples of such ablation catheters 80 include, but are not limited
to, those disclosed in U.S. Pat. Nos. 6,245,066 entitled "Ablation
Catheter" issued to John Mark Morgan and Andrew David Cunningham on
Jun. 12, 2001; 5,267,954 entitled "Ultra-sound catheter for
removing obstructions from tubular anatomical structures such as
blood vessels" issued to Henry Nita on Dec. 7, 1993; 6,325,797
entitled "Ablation Catheter and Method for Isolating a Pulmonary
Vein" issued to Mark T. Stewart, William J. Flickinger, David E.
Franscischelli, Rahul Mehra and Xiaoyi Min on Dec. 4, 2001;
6,203,537 entitled "Laser-driven Acoustic Ablation Catheter" issued
to Sorin Adrian on Mar. 20, 2001; 5,427,118 entitled "Ultrasonic
Guidewire" issued to John H. Wang, Henry Nita, Timothy C. Mills,
and Douglas H. Gesswin on Jun. 27, 1995; 6,701,176 entitled
"Magnetic-resonance-guided imaging, electrophysiology, and
ablation" issued to Henry R. Halperin, Ronald D. Berger, Ergin
Atalar, Elliot R. McVeigh, Albert Lardo, Hugh Calkins and Joao Lima
on Mar. 2, 2004; 6,231,518 entitled "Intrapericardial
electrophysiological procedures" issued to James R. Grabek, Carl M.
Beaurline, Cecil C. Schmidt, Lawrence A. Lundeen and Patricia J.
Rieger on May 15, 2001; 6,949,094 entitled "Miniature Refrigeration
System for Cryothermal Ablation Catheter" issued to Ran Yaron on
Sep. 27, 2005; 6,592,612 entitled "Method and apparatus for
providing heat exchange within a catheter body" issued to Wilfred
Samson, Hoa Nguyen, Mike Lee, Brady Esch, Eric Olsen and Jeff Valko
on Jul. 15, 2003; 7,291,146 entitled "Selectable Eccentric
Remodeling and/or Ablation of Atherosclerotic Material" issued to
Tom A. Steinke, Corbett W. Stone, Stephen O. Ross, Brian S.
Kelleher, Raphael M. Michel and Donald H. Koenig on Nov. 6, 2007;
7,742,795 entitled "Tuned RF energy for Selective Treatment of
Atheroma and Other Target Tissues and/or Structures" issued to
Corbett W. Stone, Michael F. Hoey, Tom A. Steinke, Raphael M.
Michel and Arthur G. Blanck on Jun. 22, 2010; US Published Patent
Application Nos. 2003092995 entitled "System and method of
positioning implantable medical devices" filed by David L. Thompson
on Feb. 28, 2002; 2006184048 entitled "Tissue Visualization and
Manipulation System" filed by Vahid Saadat on Oct. 25, 2005;
2010256616 entitled "Recanalizing Occluded Vessels Using
Radiofrequency Energy" filed by Osamu Katoh and Wayne Ogata on Apr.
2, 2010, 2008262489 entitled "Thrombus Removal" and filed by Tom A.
Steinke on Apr. 23, 2008; 2008125772 entitled "Tuned RF Energy and
Electrical Tissue Characterization for Selective Treatment of
Target Tissues" filed by Corbett W. Stone, Michael F. Hoey, Tom A.
Steinke, Raphael M. Michel, Arthur G. Blanck, Marlene Kay Truesdale
and Bret Herscher on Oct. 18, 2007 and 2010125268 entitled
"Selective Accumulation of Energy With or Without Knowledge of
Tissue Topography" filed by Rolfe Tyson Gustus, Linas Kunstmanas
and Arthur G. Blanck on Nov. 12, 2009 and WIPO Published Patent
Application No. WO03073950 entitled "Optical Fibre Catheter for
Thermal Ablation" filed by Andrea Venturelli on Jan. 27, 2003, the
teachings of which are incorporated by reference herein in their
entirety. Further examples of RF ablation systems include, but are
not limited to ablative systems such as that sold by Halt Medical
Inc. of Livermore, Calif. that use the heat energy of radio
frequency waves to ablate tissue, those sold by Covidien plc
through its Valleylab brand in Boulder, Colo. and the VNUS.RTM. RF
(radiofrequency) Ablation system sold by AngioDynamics of Latham,
N.Y.
[0088] The ablation catheter 82 has a catheter body 84 with a
distal end 86, a proximal end 88, a central lumen 90 through which
a guide wire (not shown) may be passed, an outer surface 92 and
ablation system 94. The ablation catheter 82 preferably has, but is
not required to have, an imaging transducer 14 as part of an
imaging system 2 located at its distal end 86. As the ablation
catheter 82 is advanced to the site of the lesion, the imaging
system 2, if present, helps the physician to locate the lesion.
Once the ablation catheter 82 is located at the lesion, the
ablation therapy is applied by the ablation system 94 to ablate the
lesion. The imaging system 2 may be particularly useful in helping
the physician apply the ablation therapy and assess the extent of
such ablation.
[0089] In an alternate embodiment of the device of FIG. 14 shown in
FIG. 15, the imaging system 2 is an OCT system and ablation system
94 is combined with the distal optics 22 of the imaging system 2.
In a variant of this embodiment, the ablation provided by the
ablation system 94 is laser ablation that is supplied to the
ablation system 94 from the same light source 20 used by the OCT
system to produce the OCT images, typically through optical fibers
24 connecting the light source 20 to the distal optics 22. Although
the light source 20 used to produce the OCT images would typically
be located remotely from the distal optics 22 supplied light via
the optical fibers 24, it is within the scope of the present
invention in all embodiments for the light source 20 to be located
in close proximity to the distal optics 22. In a variant of this,
this same light source 20 provides not only the light needed to
produce the OCT images but also the laser light used by the
ablation system 94 to do the ablation.
[0090] Yet another embodiment of a device of another therapy that
could be applied as the therapy in step 42 is shown in FIG. 16. In
this embodiment, a therapeutic agent deliver catheter 96 is shown.
Such therapeutic agent deliver catheter 96 delivers a therapeutic
agent to the lesion to dissolve fibrin or thrombus present at or
causing the lesion or otherwise treat the lesion. Examples of such
therapeutic agent delivery catheters 92 include, but are not
limited to, those disclosed in U.S. Pat. Nos. 5,135,516 entitled
"Lubricious Antithrombogenic Catheters, Guidewires and Coatings"
issued to Ronald Sahatjian and Kurt Amplatz on Aug. 4, 1992;
6,535,764 entitled "Gastric treatment and diagnosis device and
method" issued to Mir A. Imran, Olivier K. Colliou, Ted W. Layman,
Deepak R. Gandhi and Sharon L. Lake on Mar. 18, 2003; 5,336,178
entitled "Intravascular Catheter with Infusion Array" issued to
Aaron V. Kaplan, James R. Kermode and Enrique J. Klein on Aug. 9,
1994; 7,063,679 entitled "Intra-aortic Renal Delivery Catheter"
issued to Mark Maguire and Richard Geoffrion on Jun. 20, 2006;
7,292,885 entitled "Mechanical Apparatus and Method for Dilating
and Delivering a Therapeutic Agent to a site of Treatment" issued
to Neal Scott and Jerome Segal on Nov. 6, 2007; 6,179,809 entitled
"Drug Delivery Catheter with Tip Alignment" issued to Alexander
Khairkhahan, Michael J. Horzewski, Stuart D. Harman, Richard L.
Mueller and Douglas R. Murphy-Chutorian on Jan. 30, 2001; 5,419,777
entitled "Catheter for Injecting a Fluid or Medicine" issued to
Berthold Hofling on May 30, 1995; 6,733,474 entitled "Catheter for
Tissue dilatation and drug Delivery" issued to Richard S. Kusleika
on May 11, 2004; and 2010168714 entitled "Therapeutic Agent
Delivery System" filed by Jessica L. Burke, Grant T. Hoffman and
Drew P. Lyons, Ellettsville, Ind. 1US) on Feb. 3, 2010; 2010125238
entitled "Iontophoretic Therapeutic Agent Delivery System" filed by
Whye-Kei Lye and Kareen Looi on Nov. 7, 2009; 2003032936 entitled
"Side-exit Catheter and Method for its Use" filed by Robert J.
Lederman on Aug. 10, 2001, the teachings of which are incorporated
by reference herein in their entirety. Examples of therapeutic
agents that may be delivered to the lesion include, but are not
limited to tissue plasminogen activator, urokinase, streptokinase,
collagenace, hepranoids and any other fibrinolytic or direct
anti-thrombin drug. The therapeutic agent deliver catheter 96 has a
catheter body 98 with a distal end 100, a proximal end 102, a
central lumen 104 through which a guide wire (not shown) may be
passed, an outer surface 106, a balloon 108 and a balloon lumen
110. The therapeutic agent deliver catheter 96 preferably has, but
is not required to have, an imaging transducer 14 as part of an
imaging system 2 located at its distal end 100. The balloon 108 is
inflated and deflated via the balloon lumen 110 as is well
understood in the art.
[0091] The balloon 108 delivers the therapeutic agent. The
therapeutic agent may coat the balloon 108 so that as the balloon
is inflated, the therapeutic agent is brought into contact with a
lesion so that the therapeutic agent may be applied to the lesion.
Alternately, the balloon 108 may be porous or have slits or other
fenestrations to allow therapeutic agent present within the balloon
to pass through the pores, slits or other fenestrations to come
into contact with the tissue at or near a stenosis. As the
therapeutic agent deliver catheter 96 is advanced to the site of
the lesion, the imaging system 2, if present, helps the physician
to locate the lesion. Once the therapeutic agent deliver catheter
96 is located at the lesion, the therapeutic agent to is applied to
the lesion as described above. The imaging system 2 may be
particularly useful in helping the physician apply the therapeutic
agent and assess the extent of such therapy.
[0092] The therapeutic method 30 is also typically run as software
on a computing device 8 and thus the combination of the computing
device 8 and the therapeutic methods 24, as described above,
becomes the therapeutic device 32 (FIG. 17). Although the
therapeutic device 32 is preferably operated on a computing device
8, the therapeutic device 32 may also be operated separately on any
system having sufficient computing capability to perform the steps
of the therapeutic method 30, and diagnostic method 26 if present,
and be operatively to the console 4, computing device 8,
characterization application 12 or database 10 or any combination
of these. In addition, the therapeutic device 32 may also be an
application specific device or hardwired specifically to perform
the functions described herein.
[0093] The therapeutic device 32, in preferred embodiments, acts
according to algorithms described above in connection with the
therapeutic method 30. The therapeutic device 32 may be implemented
on or may be an adjunct to an imaging system 2. The imaging system
2 may take the form of an intravascular ultrasound (IVUS) imaging
system 2 as described above including a console 4, IVUS catheter 6,
a computing device 8 comprising a database 10 and a
characterization application 12 electrically connected to the
database 10 and typically run on the computing device 8.
Alternately or in addition, the imaging system 2 may take the form
of an optical coherence tomography (OCT) system that also includes
a console 4, OCT catheter 6, a computing device 8 comprising a
database 10 and a characterization application 12 electrically
connected to the database 10 and typically run on the computing
device 8.
[0094] In several embodiments of the invention described herein,
the therapy delivery device 26 such as the balloon catheter 52,
cutting catheter 68, ablation catheter 82 and therapeutic agent
deliver catheter 96 included an imaging transducer 14 as part of an
imaging system 2 that allowed the therapy delivery device to be
located with respect to the lesion so that the therapy could be
most effectively applied. In any of the therapy delivery systems
described herein, it is preferable but not required but not
required to add an imaging transducer 14 as part of an imaging
system 2, typically near the distal end of such therapy delivery
devices, to also allow the therapy delivery device to be located
with respect to the lesion so that the therapy can be most
effectively applied.
[0095] In any of the embodiments for administering a therapy
described above, it may also be useful to apply embolic protection
to prevent pieces of fibrin, thrombus or other tissue dislodged by
the application of therapy in step 42 from moving downstream with
the blood flow. Since the primary therapeutic application of the
invention described herein is intended to be applied to a patient's
internal jugular veins (IJV) or azygous veins (AZV), such unwanted
material will move with the blood downstream into the patient's
heart and ultimately into the patient's lungs where such material
may cause an embolism. Consequently, the use of embolic protection
such as the SpiderFX.RTM. Embolic Protection Device made and sold
by ev3, Inc. of Plymouth, Minn. and the FilterWire EZ.TM.Embolic
Protection System for SVG's made and sold by Boston Scientific,
Inc. of Natick, Mass. may help prevent the occurrence of such
embolisms.
[0096] The therapeutic method 30 in another embodiment shown in
FIG. 18 includes a step 114 so that the program passes from step 42
to step 114. In step 114, intraluminal abnormalities are assessed
to see if the therapy of step 42 worked. A preferred way to assess
the intraluminal abnormalities is to reintroduce the diagnostic
catheter over the same exchange wire used as part of the therapy of
step 42 to perform a post-therapy selective venogram and assess the
residual stenosis of the lesion.
[0097] In a variant of all the therapeutic methods 24, as shown in
FIG. 19, it is desirable to assess the pressure gradient across the
stenosis after the therapy of step 42 has been applied.
Consequently, after step 42 has been completed, the method passes
to step 116. At step 116, the pressure gradient across the stenosis
is assessed as described in step 38 to determine, post-therapy,
whether adequate blood flow is now present as a result of the
therapy of step 42.
[0098] Further, it may be desirable to assess the nature of the
stenotic lesion post-therapy. Consequently, in another embodiment
of the therapeutic methods 24, as shown in FIG. 20, this assessment
of the nature of the stenotic lesion post-therapy is preferably
accomplished as step 118 by applying IVUS or OCT or both IVUS and
OCT to the area of the applied therapy in step 42. As mentioned
above, a significant stenosis is defined as luminal reduction
greater than 50% of normal venous diameter as obtained during step
36 or a significant flow disruption associated with an intraluminal
abnormality noted during the IVUS or OCT imaging at step 38.
Consequently, a successful therapy occurs when the stenosis now has
a luminal reduction less than 50% of normal venous diameter as
obtained during step 36 with no significant flow disruption.
[0099] Although embodiments of the therapeutic method 30 have been
described above in connection with a step 42 with may optionally
include either step 116 or 118, an alternate therapeutic method 30
may also include both step 116 and 118 performed in any order.
[0100] In addition, if the therapy of step 42 was not sufficient to
provide the desired blood flow or the desired reduction of the
stenosis, in an additional embodiment of the therapeutic method 30,
additional therapy of any of the types described above may be
applied as shown in FIG. 21. As mentioned above, the desired
reduction of the stenosis is such that the residual stenosis is
less than 75% of the normal proximal diameter of the stenotic vein
or that a pressure gradient exceeding 1 mm Hg is no longer
observed. In this embodiment of the therapeutic method 30,
additional therapy will be performed if these therapy goals are not
observed. Consequently, in this embodiment of the therapeutic
method 30, if the therapy goals are not met, the program passes
from step 42 to step 120 where step 120 is the application of an
additional therapy. The therapy of step 120 may be either the
reapplication of the same therapy that was applied in step 42 or
the application of an entirely new therapy of the types described
above. In this embodiment of the therapeutic method 30, steps 114,
116 may also be applied as described in connection with step 42 or
applied singly or in combination to step 120.
[0101] Further, as shown in FIG. 22, after either step 42 or step
120, additional therapy may also be performed at step 122 on all
affected veins using the same techniques described above in step 42
if there are additional affected veins with significant stenoses in
the IJV or AZV. Further, additional therapies or the reapplication
of any of the therapies listed above in connection with steps 42
and 120 may be applied to these additional affected veins.
[0102] The present invention has been described in connection with
many different diagnostic and therapeutic methods and devices. The
present invention also anticipates that more than one diagnostic
method and device may be applied or combined into a single method
or device. Likewise, the present invention also anticipates that
more than one therapeutic method and device may be applied or
combined into a single method or device. Further, various
permutations and combinations of diagnostic and therapeutic devices
may be combined together, each acting according to the descriptions
above, into a single method or single device.
[0103] Although imaging systems 2 described herein have been either
intravascular ultrasound (IVUS) systems or optical coherence
tomography (OCT) systems, any other system capable of producing an
image of a patient's vasculature may be used as the imaging system
2. Further, although the inventions described herein have been
described as being directed to primarily to the diagnosis and
treatment of MS, it is also within the scope of the invention to be
directed at diagnosing and treating deep vein thrombosis (DVT) and
pulmonary embolisms. To diagnose and treat these maladies, the
devices and methods described herein are placed in the peripheral
veins or pulmonary vessels, respectively, instead of in the IJV or
AZV. For these maladies, embodiments of the invention described
herein that remove thrombus from the vessel wall may be
particularly useful.
[0104] The present invention has been described in connection with
certain embodiments, combinations, configurations and relative
dimensions. It is to be understood, however, that the description
given herein has been given for the purpose of explaining and
illustrating the invention and are not intended to limit the scope
of the invention. In addition, it is clear than an almost infinite
number of minor variations to the form and function of the
disclosed invention could be made and also still be within the
scope of the invention. Consequently, it is not intended that the
invention be limited to the specific embodiments and variants of
the invention disclosed. It is to be further understood that
changes and modifications to the descriptions given herein will
occur to those skilled in the art. Therefore, the scope of the
invention should be limited only by the scope of the claims.
* * * * *