U.S. patent application number 12/269770 was filed with the patent office on 2010-05-13 for minimally invasive imaging systems.
Invention is credited to James S. Cybulski, Xiaolong OuYang, Fred R. Seddiqui.
Application Number | 20100121139 12/269770 |
Document ID | / |
Family ID | 42165839 |
Filed Date | 2010-05-13 |
United States Patent
Application |
20100121139 |
Kind Code |
A1 |
OuYang; Xiaolong ; et
al. |
May 13, 2010 |
Minimally Invasive Imaging Systems
Abstract
Aspects of the invention include minimally invasive imaging
system. Systems according to embodiments of the invention include:
an access device having a proximal end and distal end and an
internal passageway extending from the proximal to distal end; and
an elongated member dimensioned to be slidably moved through the
internal passageway of the access device and having a proximal and
distal end. In the systems of the invention, at least one of
multiple visualization elements and multiple illumination elements
are positioned among the distal ends of the access device and the
elongated member. Also provided are methods of using the systems in
imaging applications, as well as kits for performing the
methods.
Inventors: |
OuYang; Xiaolong; (Palo
Alto, CA) ; Cybulski; James S.; (Menlo Park, CA)
; Seddiqui; Fred R.; (Los Altos, CA) |
Correspondence
Address: |
BOZICEVIC, FIELD & FRANCIS LLP
1900 UNIVERSITY AVENUE, SUITE 200
EAST PALO ALTO
CA
94303
US
|
Family ID: |
42165839 |
Appl. No.: |
12/269770 |
Filed: |
November 12, 2008 |
Current U.S.
Class: |
600/104 ;
600/160 |
Current CPC
Class: |
A61B 1/00094 20130101;
A61B 1/00087 20130101; A61B 2018/00982 20130101; A61B 5/0084
20130101; A61B 1/042 20130101; A61B 1/00193 20130101; A61B 1/00181
20130101; A61B 1/015 20130101; A61B 1/00154 20130101; A61B 1/0125
20130101; A61B 2017/00296 20130101 |
Class at
Publication: |
600/104 ;
600/160 |
International
Class: |
A61B 1/06 20060101
A61B001/06; A61B 1/00 20060101 A61B001/00 |
Claims
1. A minimally invasive imaging system, the imaging system
comprising: (a) an access device having a proximal end and distal
end and an internal passageway extending from the proximal end to
the distal end; and (b) an elongated member dimensioned to be
slidably moved through the internal passageway of the access device
and having a proximal and distal end; wherein at least one of
multiple visualization elements and multiple illumination elements
are positioned among the distal ends of the access device and the
elongated member.
2. The minimally invasive imaging system according to claim 1,
wherein multiple visualization elements are positioned among the
distal ends of the access device and the elongated member.
3. The minimally invasive imaging system according to claim 2,
wherein the multiple visualization elements are positioned at the
distal end of the elongated member.
4. The minimally invasive imaging system according to claim 3,
wherein the multiple visualization elements are positioned to
provide for at least one of enhanced field of view and stereoscopic
view.
5. The minimally invasive imaging system according to claim 2,
wherein the multiple visualization elements are positioned at the
distal end of the access device.
6. The minimally invasive imaging system according to claim 2,
wherein a first visualization element is positioned at the distal
end of the elongated member and a second visualization element is
positioned at the distal end of the access device.
7. The minimally invasive imaging system according to claim 1,
wherein multiple illumination elements are positioned among the
distal ends of the access device and the member.
8. The minimally invasive imaging system according to claim 7,
wherein multiple illumination elements are positioned at the distal
end of the elongated member.
9. The minimally invasive imaging system according to claim 7,
wherein multiple illumination elements are positioned at the distal
end of the access device.
10. The minimally invasive imaging system according to claim 1,
wherein the visualization elements are selected from CCD and CMOS
sensors.
11. The minimally invasive imaging system according to claim 1,
wherein the illumination elements are light emitting diodes.
12. The minimally invasive imaging system according to claim 1,
wherein the elongated member further comprises a tissue
modifier.
13. The minimally invasive imaging system according to claim 1,
wherein the tissue modifier is chosen from an electrode, cutting
element and laser.
14. The minimally invasive imaging system according to claim 1,
wherein the elongate member further includes an irrigation lumen
and an aspiration lumen.
15. A method of imaging an internal target tissue of a patient, the
method comprising: (a) positioning a minimally invasive access
device having a proximal end and distal end and an internal
passageway so that the distal end is near the target tissue; and
(b) slidably moving an elongated member having a proximal and
distal end through the internal passageway of the access device so
that the distal end of the elongated member is operably positioned
relative to the target tissue; wherein at least one of multiple
visualization elements and multiple illumination elements are
positioned among the distal ends of the access port and the
elongated member; (c) illuminating the target tissue with at least
one of the multiple illumination elements; and (d) obtaining image
data of the target tissue with at least one of the visualization
elements.
16-28. (canceled)
29. A kit comprising: (a) a minimally invasive access device having
a proximal end and distal end and an internal passageway extending
from the proximal to distal end; and (b) elongated member
dimensioned to be slidably moved through the internal passageway of
the access device and having a proximal and distal end; wherein at
least one of multiple visualization elements and multiple
illumination elements are positioned among the distal ends of the
access device and the catheter.
30-42. (canceled)
43. A minimally invasive access device having a proximal end and
distal end and an internal passageway extending from the proximal
to distal end, wherein at least one of multiple visualization
elements and multiple illumination elements are positioned at the
distal end of the access device.
44. The minimally invasive access device according to claim 43,
wherein the access device comprises multiple illumination
elements.
45. The minimally invasive access device according to claim 43,
wherein the access device comprises multiple visualization
elements.
46. The minimally invasive access device according to claim 43,
wherein the access device comprises multiple illumination elements
and multiple visualization elements.
47-48. (canceled)
Description
[0001] Many pathological conditions in the human body may be caused
by enlargement, movement, displacement and/or a variety of other
changes of bodily tissue, causing the tissue to press against (or
"impinge on") one or more otherwise normal tissues or organs. For
example, a cancerous tumor may press against an adjacent organ and
adversely affect the functioning and/or the health of that organ.
In other cases, bony growths (or "bone spurs"), arthritic changes
in bone and/or soft tissue, redundant soft tissue, or other
hypertrophic bone or soft tissue conditions may impinge on nearby
nerve and/or vascular tissues and compromise functioning of one or
more nerves, reduce blood flow through a blood vessel, or both.
Other examples of tissues which may grow or move to press against
adjacent tissues include ligaments, tendons, cysts, cartilage, scar
tissue, blood vessels, adipose tissue, tumor, hematoma, and
inflammatory tissue.
[0002] The intervertebral disc 10 is composed of a thick outer ring
of cartilage (annulus fibrosus, 12) and an inner gel-like substance
(nucleus pulposus 14). A three-dimensional view of an
intervertebral disc is provided in FIG. 1. The annulus 10 contains
collagen fibers that form concentric lamellae 16 that surround the
nucleus and insert into the endplates of the adjacent vertebral
bodies. The nucleus pulposus 14 comprises proteoglycans entrapped
by a network of collagen and elastin fibers which has the capacity
to bind water. When healthy, the intervertebral disc keeps the
spine flexible and serves as a shock absorber by allowing the body
to accept and dissipate loads across multiple levels in the
spine.
[0003] With respect to the spine and intervertebral discs, a
variety of medical conditions can occur in which it is desirable to
ultimately surgically remove at least some of if not all of an
intervertebral disc. As such, a variety of different conditions
exist where partial or total disc removal is desirable.
[0004] One such condition is disc herniation. Over time, the
nucleus pulposus becomes less fluid and more viscous as a result of
age, normal wear and tear, and damage caused from an injury. The
proteoglycan and water from within the nucleus decreases which in
turn results in the nucleus drying out and becoming smaller and
compressed. Additionally, the annulus tends to thicken, desiccate,
and become more rigid, lessening its ability to elastically deform
under load and making it susceptible to disc fissures.
[0005] A fissure occurs when the fibrous components of the annulus
become separated in particular areas, creating a tear within the
annulus. The most common type of fissure is a radial fissure in
which the tear is perpendicular to the direction of the fibers. A
fissure associated with disc herniation generally falls into three
types of categories: 1) contained disc herniation (also known as
contained disc protrusion); 2) extruded disc herniation; and 3)
sequestered disc herniation (also known as a free fragment.) In a
contained herniation, a portion of the disc protrudes or bulges
from a normal boundary of the disc but does not breach the outer
annulus fibrosis. In an extruded herniation, the annulus is
disrupted and a segment of the nucleus protrudes/extrudes from the
disc. However, in this condition, the nucleus within the disc
remains contiguous with the extruded fragment. With a sequestered
disc herniation, a nucleus fragment separates from the nucleus and
disc.
[0006] As the posterior and posterolateral portions of the annulus
are most susceptible to herniation, in many instances, the nucleus
pulposus progresses into the fissure from the nucleus in a
posteriorly or posterolateral direction. Additionally, biochemicals
contained within the nucleus pulposus may escape through the
annulus causing inflammation and irritating adjacent nerves.
Symptoms of a herniated disc generally include sharp back or neck
pain which radiates into the extremities, numbness, muscle
weakness, and in late stages, paralysis, muscle atrophy and bladder
and bowel incontinence.
[0007] Conservative therapy is the first line of treating a
herniated disc which includes bed rest, medications to reduce
inflammation and pain, physical therapy, patient education on
proper body mechanics and weight control.
[0008] If conservative therapy offers no improvement then surgery
is recommended. Open discectomy is the most common surgical
treatment for ruptured or herniated discs. The procedure involves
an incision in the skin over the spine to remove the herniated disc
material so it no longer presses on the nerves and spinal cord.
Before the disc material is removed, some of the bone from the
affected vertebra may be removed using a laminotomy or laminectomy
to allow the surgeon to better see the area. As an alternative to
open surgery, minimally invasive techniques have been rapidly
replacing open surgery in treating herniated discs. Minimally
invasive surgery utilizes small skin incisions, thereby minimizing
the damaging effects of large muscle retraction and offering rapid
recovery, less post-operative pain and small incisional scars.
SUMMARY
[0009] Aspects of the invention include minimally invasive imaging
system. Systems according to embodiments of the invention include:
an access device having a proximal end and distal end and an
internal passageway extending from the proximal to distal end; and
an elongated member dimensioned to be slidably moved through the
internal passageway of the access device and having a proximal and
distal end. In the systems of the invention, at least one of
multiple visualization elements and multiple illumination elements
are positioned among the distal ends of the access device and the
elongated member. Also provided are methods of using the systems in
imaging applications, as well as kits for performing the
methods.
BRIEF DESCRIPTION OF THE FIGURES
[0010] FIG. 1 provides a three-dimensional view of an
intervertebral disc according to one embodiment of the
invention.
[0011] FIG. 2 provides a view of a cross section of the proximal
end of a surgical device configured to remove the nucleus pulposus
of an intervertebral disc (IVD) according to an embodiment of the
invention.
[0012] FIG. 3 provides a view of an access device according to an
embodiment of the invention.
[0013] FIG. 4 illustrates a visualization device according to one
embodiment of the invention viewing the nucleus pulposus of an
intervertebral disc through an access port provided by a access
device, such as a retractor tube.
[0014] FIG. 5 provides a diagrammatic view of the positioning of
two imaging sensors to provide a stereoscopic view of an internal
target tissue site.
[0015] FIG. 6 provides a schematic representation of the
operational framework of a processor that may be present in a
device according to embodiments of the invention.
DETAILED DESCRIPTION
[0016] Aspects of the invention include minimally invasive imaging
system. Systems according to embodiments of the invention include:
an access device having a proximal end and distal end and an
internal passageway extending from the proximal to distal end; and
an elongated member dimensioned to be slidably moved through the
internal passageway of the access device and having a proximal end
and a distal end. In the systems of the invention, at least one of
multiple visualization elements and multiple illumination elements
are positioned among the distal ends of the access device and the
elongated member. Also provided are methods of using the systems in
imaging applications, as well as kits for performing the
methods.
[0017] Before the present invention is described in greater detail,
it is to be understood that this invention is not limited to
particular embodiments described, as such may, of course, vary. It
is also to be understood that the terminology used herein is for
the purpose of describing particular embodiments only, and is not
intended to be limiting, since the scope of the present invention
will be limited only by the appended claims.
[0018] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limit of that range and any other stated or intervening
value in that stated range, is encompassed within the invention.
The upper and lower limits of these smaller ranges may
independently be included in the smaller ranges and are also
encompassed within the invention, subject to any specifically
excluded limit in the stated range. Where the stated range includes
one or both of the limits, ranges excluding either or both of those
included limits are also included in the invention.
[0019] Certain ranges are presented herein with numerical values
being preceded by the term "about." The term "about" is used herein
to provide literal support for the exact number that it precedes,
as well as a number that is near to or approximately the number
that the term precedes. In determining whether a number is near to
or approximately a specifically recited number, the near or
approximating unrecited number may be a number which, in the
context in which it is presented, provides the substantial
equivalent of the specifically recited number.
[0020] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
any methods and materials similar or equivalent to those described
herein can also be used in the practice or testing of the present
invention, representative illustrative methods and materials are
now described.
[0021] All publications and patents cited in this specification are
herein incorporated by reference as if each individual publication
or patent were specifically and individually indicated to be
incorporated by reference and are incorporated herein by reference
to disclose and describe the methods and/or materials in connection
with which the publications are cited. The citation of any
publication is for its disclosure prior to the filing date and
should not be construed as an admission that the present invention
is not entitled to antedate such publication by virtue of prior
invention. Further, the dates of publication provided may be
different from the actual publication dates which may need to be
independently confirmed.
[0022] It is noted that, as used herein and in the appended claims,
the singular forms "a", "an", and "the" include plural referents
unless the context clearly dictates otherwise. It is further noted
that the claims may be drafted to exclude any optional element. As
such, this statement is intended to serve as antecedent basis for
use of such exclusive terminology as "solely," "only" and the like
in connection with the recitation of claim elements, or use of a
"negative" limitation.
[0023] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual embodiments
described and illustrated herein has discrete components and
features which may be readily separated from or combined with the
features of any of the other several embodiments without departing
from the scope or spirit of the present invention. Any recited
method can be carried out in the order of events recited or in any
other order which is logically possible.
[0024] In further describing various aspects of the invention,
embodiments of the minimally invasive imaging systems and
components thereof are reviewed first in greater detail, followed
by a review of embodiments of methods of using the devices.
Minimally Invasive Imaging Systems
[0025] As summarized above, aspects of the invention include
minimally invasive imaging systems. The imaging systems of the
invention are minimally invasive, such that they may be introduced
to an internal target site of a patient, e.g., a spinal location
that is near or inside of an intervertebral disc, through a minimal
incision, e.g., one that is less than the size of an incision
employed for an access device having a outer diameter of 20 mm or
larger, e.g., less than 75% the size of such an incision, such as
less than 50% of the size of such an incision, or smaller.
[0026] Imaging systems of the invention include both an access
device and an elongate member. The access device is a device having
a proximal end and a distal end and an internal passageway
extending from the proximal to distal end. Similarly, the elongated
member has a proximal end and a distal end and is dimensioned to be
slidably moved through the internal passageway of the access
device. Aspects of the invention include at least one of multiple
visualization elements and multiple illumination elements that are
positioned among the distal ends of the access device and the
elongated member.
[0027] Access devices of the invention are elongated elements
having an internal passageway that are configured to provide access
to a user (e.g., a health care professional, such as a surgeon)
from an extra-corporeal location to an internal target tissue site,
e.g., a location near or in the spine or component thereof, e.g.,
near or in an intervertebral disc, inside of the disc, etc.,
through a minimally invasive incision. Access devices of the
invention may be cannulas, components of retractor tube systems,
etc. As the access devices are elongate, they have a length that is
1.5 times or longer than their width, such as 2 times or longer
than their width, including 5 or even 10 times or longer than their
width, e.g., 20 times longer than its width, 30 times longer than
its width, or longer.
[0028] Where the access devices are configured to provide access
through a minimally invasive incision, the longest cross-sectional
outer dimension of the access devices (for example, the outer
diameter of a tube shaped access device, including wall thickness
of the access device, which may be a port or cannula in some
instances) ranges in certain instances from 5 mm to 50 mm, such as
10 to 20 mm. With respect to the internal passageway, this passage
is dimensioned to provide passage of the tools, e.g., imaging
devices, tissue modifiers, etc., from an extra-corporeal site to
the internal target tissue location. In certain embodiments, the
longest cross-sectional dimension of the internal passageway, e.g.,
the inner diameter of a tubular shaped access device, ranges in
length from 5 to 30 mm, such as 5 to 25 mm, including 5 to 20 mm,
e.g., 7 to 18 mm. Where desired, the access devices are
sufficiently rigid to maintain mechanical separation of tissue,
e.g., muscle, and may be fabricated from any convenient material.
Materials of interest from which the access devices may be
fabricated include, but are not limited to: metals, such as
stainless steel and other medical grade metallic materials,
plastics, and the like.
[0029] The systems of the invention further include an elongate
member having a proximal and distal end, where the elongate member
is dimensioned to be slidably moved through the internal passageway
of the access device. As this component of the systems is elongate,
it has a length that is 1.5 times or longer than its width, such as
2 times or longer than its width, including 5 or even 10 times or
longer than its width, e.g., 20 times longer than its width, 30
times longer than its width, or longer. When designed for use in
IVD procedures, the elongate member is dimensioned to access an
intervertebral disc. By "dimensioned to access an intervertebral
disc" is meant that at least the distal end of the device has a
longest cross-sectional dimension that is 10 mm or less, such as 8
mm or less and including 7 mm or less, where in certain embodiments
the longest cross-sectional dimension has a length ranging from 5
to 10 mm, such as 6 to 9 mm, and including 6 to 8 mm. The elongate
member may be solid or include one or more lumens, such that it may
be viewed as a catheter. The term "catheter" is employed in its
conventional sense to refer to a hollow, flexible or semi-rigid
tube configured to be inserted into a body. Catheters of the
invention may include a single lumen, or two or more lumens, e.g.,
three or more lumens, etc, as desired. Depending on the particular
embodiment, the elongate members may be flexible or rigid, and may
be fabricated from any convenient material.
[0030] As summarized above, aspects of the invention include at
least one of multiple visualization elements and multiple
illumination elements that are positioned among the distal ends of
the access device and the elongated member. By "at least one of
multiple visualization elements and multiple illumination elements"
is meant that, over all, the system includes two or more
visualization elements and/or two or more illumination elements
that are located among the distal ends of access device and
elongated member. Accordingly, embodiments of the systems include
those systems where two or more visualization elements are located
at the distal end of the elongated member. Embodiments of the
systems also include those systems where one visualization element
is located at the distal end of the elongated member and another
visualization element is located at the distal end of the access
device. Furthermore, embodiments of the systems include those
systems where two or more visualization elements are located at the
distal end of the access device.
[0031] Similarly, with respect to the illumination elements,
embodiments of the systems include those systems where two or more
illumination elements are located at the distal end of the
elongated member. Embodiments of the systems also include those
systems where one illumination element is located at the distal end
of the elongated member and another illumination element is located
at the distal end of the access device. Furthermore, embodiments of
the systems include those systems where two or more illumination
elements are located at the distal end of the access device.
[0032] Accordingly, the phrase "among the distal ends of the access
device and elongated member" means that between the two distal
ends, there is positioned at least one of multiple visualization
elements and multiple illumination elements. By "located among the
distal ends" is meant that the item of interest (e.g., the
visualization element, the illumination element) is present at the
distal end of the elongate member and/or access device, or near the
distal end of the elongate member and/or access device, e.g.,
within 10 mm or closer to the distal end, such as within 5 mm or
closer to the distal end and including within 3 mm or closer to the
distal end.
[0033] Of interest as visualization elements are imaging sensors.
Imaging sensors of interest are miniature in size so as to be
positionable at the distal end of the elongate member or the access
device. Miniature imaging sensors of interest are those that, when
integrated at the distal end of an elongated structure along with
an illumination source, e.g., such as an LED as reviewed below, can
be positioned on a probe having a longest cross section dimension
of 6 mm or less, such as 5 mm or less, including 4 mm or less, and
even 3 mm or less. In certain embodiments, the miniature imaging
sensors have a longest cross-section dimension (such as a diagonal
dimension) of 5 mm or less, such 3 mm or less, where in certain
instances the sensors may have a longest cross-sectional dimension
ranging from 2 to 3 mm. In certain embodiments, the miniature
imaging sensors have a cross-sectional area that is sufficiently
small for its intended use and yet retain a sufficiently high
matrix resolution. Certain imaging sensors of the invention have a
cross-sectional area (i.e. an x-y dimension, also known as packaged
chip size) that is 2 mm.times.2 mm or less, such as 1.8
mm.times.1.8 mm or less, and yet have a matrix resolution of
400.times.400 or greater, such as 640.times.480 or greater. In some
instances, the imaging sensors have a sensitivity that is 500
mV/Lux-sec or greater, such as 700 mV/Lux-Sec or greater, including
1000 mV/Lux-Sec or greater, where in some instances the sensitivity
of the sensor is 2000 mV/Lux-Sec or greater, such as 3000
mV/Lux-Sec or greater. The imaging sensors of interest are those
that include a photosensitive component, e.g., array of
photosensitive elements, coupled to an integrated circuit, where
the integrated circuit is configured to obtain and integrate the
signals from the photosensitive array and output the analog data to
a backend processor. The image sensors of interest may be viewed as
integrated circuit image sensors, and include complementary
metal-oxide-semiconductor (CMOS) sensors and charge-coupled device
(CCD) sensors. The image sensors may further include a lens
positioned relative to the photosensitive component so as to focus
images on the photosensitive component. A signal conductor may be
present to connect the image sensor at the distal and to a device
at the proximal end of the elongate member, e.g., in the form of
one or more wires running along the length of the elongate member
from the distal to the proximal end. Imaging sensors of interest
include, but are not limited to, those obtainable from: OminVision
Technologies Inc., Sony Corporation, Cypress Semiconductors. The
imaging sensors may be integrated with the component of interest,
e.g., the access device or the elongated structure. As the imaging
sensor(s) is integrated at the distal end of the component, it
cannot be removed from the remainder of the component without
significantly compromising the structure of component. As such, the
integrated visualization element is not readily removable from the
remainder of the component, such that the visualization element and
remainder of the component form an inter-related whole.
[0034] While any convenient imaging sensor may be employed in
devices of the invention, in certain instances the imaging sensor
is a CMOS sensor. Of interest as CMOS sensors are the OmniPixel
line of CMOS sensors available from OmniVision (Sunnyvale, Calif.),
including the OmniPixel, OmniPixel2, OmniPixel3, OmniPixel3-HS and
OmniBSI lines of CMOS sensors. These sensors may be either
frontside or backside illumination sensors, and have sufficiently
small dimensions while maintained sufficient fun; ctionality to be
positioned at the distal end of the minimally invasive devices of
the invention. Aspects of these sensors are further described in
one or more the following U.S. patents, the disclosures of which
are herein incorporated by reference: U.S. Pat. Nos. 7,388,242;
7,368,772; 7,355,228; 7,345,330; 7,344,910; 7,268,335; 7,209,601;
7,196,314; 7,193,198; 7,161,130; and 7,154,137.
[0035] A variety of different types of lights sources may be
employed as illumination elements, so long as their dimensions are
such that they can be positioned at the distal end of the access
device and/or elongated member. The light sources may be integrated
with a given component (e.g., access device, elongated member) such
that they are configured relative to the component such that the
light source element cannot be removed from the remainder of the
component without significantly compromising the structure of the
component. As such, the integrated illumination element of these
embodiments is not readily removable from the remainder of the
component, such that the illumination element and remainder of the
component form an inter-related whole. The light sources may be
light emitting diodes configured to emit light of the desired
wavelength range, or optical conveyance elements, e.g., optical
fibers, configured to convey light of the desired wavelength range
from a location other than the distal end of the elongate member,
e.g., a location at the proximal end of the elongate member, to the
distal end of the elongate member. As with the image sensors, the
light sources may include a conductive element, e.g., wire, optical
fiber, which runs the length of the elongate member to provide for
control of the light sources from a location outside the body,
e.g., an extracorporeal control device. Where desired, the light
sources may include a diffusion element to provide for uniform
illumination of the target tissue site. Any convenient diffusion
element may be employed, including but not limited to a translucent
cover or layer (fabricated from any convenient translucent
material) through which light from the light source passes and is
thus diffused. In those embodiments of the invention where the
system includes two or more illumination elements, the illumination
elements may emit light of the same wavelength or they may be
spectrally distinct light sources, where by "spectrally distinct"
is meant that the light sources emit light at wavelengths that do
not substantially overlap, such as white light and infra-red light,
such as the spectrally distinct light sources described in
copending U.S. application Ser. No. ______ titled "Minimally
Invasive Imaging Device" filed on even date herewith (Attorney
docket no. AXIS-003); the disclosure of which is herein
incorporated by reference. In certain embodiments, the elongate
member of the system further includes a tissue modifier. Tissue
modifiers are components or sub-devices that interact with tissue
in some manner to modify the tissue in a desired way. The term
modify is used broadly to refer to changing in some way, including
cutting the tissue, ablating the tissue, delivering an agent(s) to
the tissue, freezing the tissue, etc. As such, of interest as
tissue modifiers are tissue cutters, tissue ablators, tissue
freezing/heating elements, agent delivery devices, etc. Tissue
cutters of interest include, but are not limited to: blades, liquid
jet devices, lasers and the like. Tissue ablators of interest
include, but are not limited to ablation devices, such as devices
for delivery ultrasonic energy (e.g., as employed in ultrasonic
ablation), devices for delivering plasma energy, devices for
delivery radiofrequency (RF) energy, devices for delivering
microwave energy, etc. Energy transfer devices of interest include,
but are not limited to: devices for modulating the temperature of
tissue, e.g., freezing or heating devices, etc.
[0036] In certain embodiments, the elongated member may further
include one or more lumens that run at least the substantial length
of the device, e.g., for performing a variety of different
functions. In certain embodiments where it is desired to flush
(i.e., wash) the location of the target tissue at the distal end of
the elongate member (e.g., to remove cut tissue from the location,
etc.), the elongated member may include both an irrigation and
aspiration lumen. During use, the irrigation lumen is operatively
connected to a fluid source (e.g., physiologically acceptable
fluid, such as saline) at the proximal end of the device, where the
fluid source is configured to introduce fluid into the lumen under
positive pressure, e.g., at a pressure ranging from 0 to 500 mm Hg,
so that fluid is conveyed along the irrigation lumen and out the
distal end. While the dimensions of the irrigating lumen may vary,
in certain embodiments the longest cross-sectional dimension of the
irrigation lumen ranges from 1 to 3 mm. During use, the aspiration
lumen is operatively connected to a source of negative pressure
(e.g., vacuum source) at the proximal end of the device, where the
negative pressure source is configured to draw fluid from the
tissue location at the distal end into the irrigation lumen under
positive pressure, e.g., at a pressure ranging from 50 to 600 mm
Hg, so that fluid is removed from the tissue site and conveyed
along the irrigation lumen and out the proximal end, e.g., into a
waste reservoir. While the dimensions of the aspiration lumen may
vary, in certain embodiments the longest cross-sectional dimension
of the aspiration lumen ranges from 1 to 4 mm, such as 1 to 3
mm.
[0037] In certain embodiments, the systems of the invention are
used in conjunction with a controller configured to control
illumination of the illumination elements and/or capture of images
(e.g., as still imaged or video output) from the image sensors.
This controller may take a variety of different formats, including
hardware, software and combinations thereof. The controller may be
physically located relative to the elongated member and/or access
device at any convenient location, where the controller may be
present at the distal end of the system components, at some point
between the distal and proximal ends or at the proximal ends of the
system components, as desired. In certain embodiments, the
controller may be distinct from the system components, i.e., access
device and elongated member, such the access device and/or
elongated member includes a controller interface for operatively
coupling to the distinct controller, or the controller may be
integral with the device.
[0038] FIG. 2 provides a cross-sectional view of the distal ends of
the elongated member and access device of a system according to one
embodiment of the invention, where the system is configured to be
employed in the surgical removal of the nucleus pulposus of an
intervertebral disc. In FIG. 2, distal end of elongated member 20
(in this embodiment a catheter) includes first imaging sensor 21
while distal end of access device 22 includes a second imaging
sensor 23. Also shown at the distal end of elongated member 20 are
first and second LEDs, 24 and 25. Also shown is an irrigation lumen
26 and aspiration lumen 27. In addition, the device includes a
tissue modifier in the form of a dissection electrode 28. In the
system shown in FIG. 2, the first imaging sensor 21 provides
visualization of the target tissue site. The second imaging sensor
23 is positioned on the access device (although it could be
positioned at a variety of locations on the access device or the
elongated member). The orientation of second imaging sensor 23 is
such that imaging sensor 23 provides imaged data of the elongated
member, e.g., of the distal end of the elongated member during
placement, etc. Any convenient positioning as use may be
achieved.
[0039] FIG. 3 provides different views of an access device
according to an embodiment of the invention. As shown in FIG. 3,
access device 30 includes a distal end 31. Positioned at distal end
31 are two cameras 32A and 32B and two illumination sources, e.g.,
LEDs or light fibers, 33A and 33B. Running the length of the access
device and exiting the proximal end are wires 34 and 35 for provide
power and control to the cameras and visualization elements, e.g.,
via coupling to a control device.
[0040] The multiple visualization and/or illumination elements of
the devices may be positioned relative to each other in a variety
of different ways. By selective positioning of these elements
coupled, as desired, with specific image data processing
techniques, unique views of the target tissue site may be obtained.
For example, as illustrated in FIG. 4, two cameras 42 and 44 may be
positioned in the same cross-section of the distal end of the
imaging device. Image data from the two cameras can, in such an
embodiment, be combined to obtain a panoramic view of the target
tissue site, in this case the nucleus pulposus. This configuration
also allows one to obtain a stereoscopic view of the target tissue
site, as illustrated in FIG. 5, e.g., by synchronizing the image
data from the two cameras. As illustrated in FIG. 5, by image
processing the depth of the circle object can be distinguished from
the square object. For embodiments where stereovision is desired,
the ratio of object distance (i.e., distance of object of interest
from the camera) to stereo baseline (i.e., camera to camera
distance) may vary, and in certain instances ranges from 10 to 30,
such as 15 to 25, e.g., 20 (e.g., where the object depth is 20 mm
and the two cameras are 1 mm apart).
[0041] Placement of the visualization elements in different cross
sections of the devices and/or on different devices can also
provide for advantages in imaging. For example, FIG. 2 provides an
illustration of a distal end of a system made up of a catheter
visualization device slidably positioned within an internal
passageway of an access device, such as a retractor tube. In the
embodiment depicted in FIG. 2, the primary camera 21 is on the
cross section of the catheter, and the secondary camera 23 is on
the wall of the access device. Both cameras can be arranged to have
certain orientations, as desired, such as forward viewing or angled
or side viewing. Illuminations can also be arranged such that
different views of the same object can be revealed. For example,
the light source can be somewhat collimated or focused in a certain
direction to give a better view of the surgical blades, electrodes
or the local tissue appearance.
[0042] The devices or components thereof may be configured for one
time use (i.e., disposable) or re-usable, e.g., where the
components are configured to be used two or more times before
disposal, e.g., where the device components are sterilizable.
Methods
[0043] Aspects of the invention further include methods of imaging
an internal tissue site with imaging devices of the invention. A
variety of internal tissue sites can be imaged with devices of the
invention. In certain embodiments, the methods are methods of
imaging an intervertebral disc in a minimally invasive manner. For
ease of description, the methods are now primarily described
further in terms of imaging IVD target tissue sites. However, the
invention is not so limited, as the devices may be used to image a
variety of distinct target tissue sites.
[0044] With respect to imaging an intervertebral disc or portion
thereof, e.g., exterior of the disc, nucleus pulposus, etc.,
embodiments of such methods include positioning a distal end of a
minimally invasive intervertebral disc imaging device of the
invention in viewing relationship to an intervertebral disc or
portion of there, e.g., nucleus pulposus, internal site of nucleus
pulposus, etc. By viewing relationship is meant that the distal end
is positioned within 40 mm, such as within 10 mm, of the target
tissue site of interest. Positioning the distal end in viewing
device in relation to the desired target tissue may be accomplished
using any convenient approach, including through use of an access
device, such as a cannula or retractor tube, which may or may not
be fitted with a trocar, as desired. Following positioning of the
distal end of the imaging device in viewing relationship to the
target tissue, the target tissue, e.g., intervertebral disc or
portion thereof, is imaged through use of the illumination and
visualization elements to obtain image data. Image data obtained
according to the methods of the invention is output to a user in
the form of an image, e.g., using a monitor or other convenient
medium as a display means. In certain embodiments, the image is a
still image, while in other embodiments the image may be a
video.
[0045] In certain embodiments, the methods include a step of tissue
modification in addition to the tissue viewing. For example, the
methods may include a step of tissue removal, e.g., using a
combination of tissue cutting and irrigation or flushing. For
example, the methods may include cutting a least a portion of the
tissue and then removing the cut tissue from the site, e.g., by
flushing at least a portion of the imaged tissue location using a
fluid introduce by an irrigation lumen and removed by an aspiration
lumen.
[0046] FIG. 4 provides a view of one embodiment of a method of
visualizing an intervertebral disc. In the embodiment illustrated
in FIG. 4, an access device, e.g., cannula, trocar, etc. is
employed to provide access of the device to the internal body site,
e.g., via a minimally sized incision. FIG. 4 shows a visualization
device according to an embodiment of the invention viewing the
nucleus pulposus of an intervertebral disc through an access port
provided by an access device, such as a cannula. In FIG. 4, the
visualization elements are positioned at the distal end of a
catheter member, and are located in the same cross-sectional plane.
Image data from the two visualization elements may be obtained and
processed to provide for an enhanced field of view, e.g., a
panoramic view, where the enhanced field of view may be one that is
wider than the view obtained from a signal visualization element
and/or provide for stereoscopic view, as illustrated in FIG. 5.
[0047] FIG. 6 provides a flow chart representation of a
stereoscopic image processing algorithm according to an embodiment
of the invention, where the algorithm is configured to derived
depth or "range" map on a two-dimensional scene. In the process
depicted in FIG. 6, left and right images 61a and 61b obtained by
two distinct visualization elements, e.g., sensors 42 and 44 as
depicted in FIG. 5, are first warped as shown at 62a and 62b via
calibration element 63 to remove lens distortion. The resultant
undistorted left and right images 64a and 64b are then processed
with stereo and image fusion algorithms 65 and 66 to derive a
disparity line 67. Finally, triangulation computations 68 are
applied to derive range data. The range (or depth) map 69 can be
overlay on the image display, as desired.
[0048] Methods of invention may find use in any convenient
application, including diagnostic and therapeutic applications.
Specific applications of interest include, but are not limited to,
intervertebral disc diagnostic and therapeutic applications. For
example, methods of the invention include diagnostic applications,
where a disc is viewed to determine any problems with the disc, if
present. Methods of the invention also include treatment methods,
e.g., where a disc is modified in some manner to treat and existing
medical condition. Treatment methods of interest include, but are
not limited to: annulotomy, nucleotomy, discectomy, annulus
replacement, nucleus replacement, and decompression due to a
bulging or extruded disc. Additional methods in which the imaging
devices find use include those described in United States Published
Application No. 20080255563
[0049] Methods and devices of the invention may be employed with a
variety of subjects. In certain embodiments, the subject is an
animal, where in certain embodiments the animal is a "mammal" or
"mammalian." The terms mammal and mammalian are used broadly to
describe organisms which are within the class mammalia, including
the orders carnivore (e.g., dogs and cats), rodentia (e.g., mice,
guinea pigs, and rats), lagomorpha (e.g. rabbits) and primates
(e.g., humans, chimpanzees, and monkeys). In certain embodiments,
the subjects (i.e., patients) are humans.
Kits
[0050] Also provided are kits for use in practicing the subject
methods, where the kits may include one or more of the above
devices, and/or components of the subject systems, as described
above. As such, a kit may include a visualization device and an
access device, e.g., a cannula configured to be employed with the
visualization device. The kit may further include other components,
e.g., guidewires, stylets, etc., which may find use in practicing
the subject methods. Various components may be packaged as desired,
e.g., together or separately.
[0051] In addition to above mentioned components, the subject kits
may further include instructions for using the components of the
kit to practice the subject methods. The instructions for
practicing the subject methods are generally recorded on a suitable
recording medium. For example, the instructions may be printed on a
substrate, such as paper or plastic, etc. As such, the instructions
may be present in the kits as a package insert, in the labeling of
the container of the kit or components thereof (i.e., associated
with the packaging or subpackaging) etc. In other embodiments, the
instructions are present as an electronic storage data file present
on a suitable computer readable storage medium, e.g. CD-ROM,
diskette, etc. In yet other embodiments, the actual instructions
are not present in the kit, but means for obtaining the
instructions from a remote source, e.g. via the internet, are
provided. An example of this embodiment is a kit that includes a
web address where the instructions can be viewed and/or from which
the instructions can be downloaded. As with the instructions, this
means for obtaining the instructions is recorded on a suitable
substrate.
Computer Readable Storage Media
[0052] Also of interest is programming that is configured for
operating a visualization device according to methods of invention,
where the programming is recorded on physical computer readable
media, e.g. any medium that can be read and accessed directly by a
computer. Such media include, but are not limited to: magnetic
storage media, such as floppy discs, hard disc storage medium, and
magnetic tape; optical storage media such as CD-ROM; electrical
storage media such as RAM and ROM; and hybrids of these categories
such as magnetic/optical storage media. One of skill in the art can
readily appreciate how any of the presently known computer readable
mediums can be used to create a manufacture comprising a storage
medium having instructions for operating a minimally invasive in
accordance with the invention.
[0053] Programming of the invention includes instructions for
operating a device of the invention, such that upon execution by
the programming, the executed instructions result in execution of
the imaging device to: illuminate a target tissue site, such as an
intervertebral disc or portion thereof; and capture one or more
image frames of the illuminated target tissue site with the imaging
sensor.
[0054] All publications and patent applications cited in this
specification are herein incorporated by reference as if each
individual publication or patent application were specifically and
individually indicated to be incorporated by reference. The
citation of any publication is for its disclosure prior to the
filing date and should not be construed as an admission that the
present invention is not entitled to antedate such publication by
virtue of prior invention.
[0055] Although the foregoing invention has been described in some
detail by way of illustration and example for purposes of clarity
of understanding, it is readily apparent to those of ordinary skill
in the art in light of the teachings of this invention that certain
changes and modifications may be made thereto without departing
from the spirit or scope of the appended claims.
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