U.S. patent application number 16/835663 was filed with the patent office on 2020-08-06 for method and apparatus for performing retro peritoneal dissection.
This patent application is currently assigned to Jeffrey B. Kleiner. The applicant listed for this patent is Jeffrey B. Kleiner. Invention is credited to Jeffrey Adair, Jeffrey Kleiner, Kevin Wiggins.
Application Number | 20200245857 16/835663 |
Document ID | / |
Family ID | 1000004769572 |
Filed Date | 2020-08-06 |
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United States Patent
Application |
20200245857 |
Kind Code |
A1 |
Kleiner; Jeffrey ; et
al. |
August 6, 2020 |
METHOD AND APPARATUS FOR PERFORMING RETRO PERITONEAL DISSECTION
Abstract
The foregoing application describes a system and method of
performing a minimally invasive surgical operation. More
specifically, the invention involves the use of disposable cannula
and slender dilators of variable lengths, which incorporate a
source of illumination to carry light to a surgical site and video
capabilities for capturing and displaying images from a CMOS or CCD
camera device. According to one embodiment, fiber optics run
semi-circumferentially or along walls of the cannula/dilator and
terminate at about a centimeter from the distal end of the
cannula/dilator, thereby preventing illumination from "bottoming
out" at the floor of the incision. According to one alternate
embodiment, the light fibers may be fashioned in an annulus around
one or more camera chips to provide illumination and video of the
surgical site. In still another embodiment, the light fibers may be
replaced by light emitting diodes in a more remote light source or
alternatively at the distal-tip of the CMOS or CCD camera
device.
Inventors: |
Kleiner; Jeffrey; (Denver,
CO) ; Adair; Jeffrey; (Highlands Ranch, CO) ;
Wiggins; Kevin; (Denver, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Kleiner; Jeffrey B. |
|
|
US |
|
|
Assignee: |
Kleiner; Jeffrey B.
Aurora
CO
|
Family ID: |
1000004769572 |
Appl. No.: |
16/835663 |
Filed: |
March 31, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15664417 |
Jul 31, 2017 |
10617293 |
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16835663 |
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14519880 |
Oct 21, 2014 |
9717403 |
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15664417 |
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13091024 |
Apr 20, 2011 |
8864654 |
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14519880 |
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14519880 |
Oct 21, 2014 |
9717403 |
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15664417 |
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14507367 |
Oct 6, 2014 |
9427264 |
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14519880 |
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13754042 |
Jan 30, 2013 |
8870882 |
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14507367 |
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12632720 |
Dec 7, 2009 |
8366748 |
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13754042 |
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14519880 |
Oct 21, 2014 |
9717403 |
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15664417 |
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12965654 |
Dec 10, 2010 |
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14519880 |
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61326138 |
Apr 20, 2010 |
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61120260 |
Dec 5, 2008 |
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61186683 |
Jun 12, 2009 |
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61262075 |
Dec 10, 2009 |
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61323984 |
Apr 14, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/0607 20130101;
A61B 90/361 20160201; A61B 1/05 20130101; A61B 1/00135 20130101;
A61B 2017/0262 20130101; A61B 1/00154 20130101; A61B 1/07 20130101;
A61B 1/32 20130101; A61B 2090/309 20160201; A61B 17/0218 20130101;
A61B 2090/306 20160201; A61B 5/4893 20130101; A61B 1/00103
20130101; A61B 1/0684 20130101; A61B 2017/00991 20130101; A61B
2017/00022 20130101; A61B 2017/0256 20130101; A61B 17/3421
20130101 |
International
Class: |
A61B 1/32 20060101
A61B001/32; A61B 1/00 20060101 A61B001/00; A61B 5/00 20060101
A61B005/00; A61B 17/34 20060101 A61B017/34; A61B 17/02 20060101
A61B017/02; A61B 1/06 20060101 A61B001/06 |
Claims
1. A surgical visualization system comprising: a surgical retractor
configured to hold open an incision and thereby provide a pathway
for access of surgical tools to a surgical site, said retractor
comprising portions configured to be disposed about an open region
located between said retractor portions so as to permit access of
surgical tools to the surgical site through said open region; at
least one camera configured to acquire video images of the surgical
site, the at least one camera disposed on the retractor and
configured to acquire video images within said surgical site to
which the retractor provides access, said at least one camera
directed inward toward said open region and directed downward into
the surgical site; and an image processing system in communication
with the at least one camera; wherein: said retractor has proximal
and distal ends, said distal end closer to said surgical site than
said proximal end, and said at least one camera is configured to be
disposed at the distal end of the retractor.
2. The system of claim 1, further comprising one or more
illumination devices comprised of fiber optic strands or bundles
for transmitting light into the surgical site, the one or more
illumination devices disposed within a wall thickness of the
surgical retractor.
3. The system of claim 2, wherein the one or more illumination
devices comprise LEDs.
4. The system of claim 1, wherein the image processing system is
configured to produce a three-dimensional type picture based on the
acquired video images.
5. The system of claim 1, wherein the at least one camera is a CMOS
or CCD camera.
6. The system of claim 1, wherein the at least one camera is a
detachable camera.
7. The system of claim 1, wherein the at least one camera is
attached to the retractor by way of a flexible sleeve.
8. The system of claim 1, wherein the at least one camera comprises
a wireless transmitter providing the communication between the
image processing system and the at least one camera.
9. The system of claim 1, wherein the at least one camera is
encircled by one or more LED illumination devices.
10. The system of claim 1, wherein the three dimensional-type
picture is free of field-flattening effects.
11. A method of presenting a three-dimensional type picture to a
surgeon, the method comprising: providing a surgical visualization
system comprising: a surgical retractor configured to hold open an
incision and thereby provide a pathway for access of surgical tools
to a surgical site, said retractor comprising portions configured
to be disposed about an open region located between said retractor
portions so as to permit access of surgical tools to the surgical
site through said open region; one or more cameras configured to
acquire video images of the surgical site, the one or more cameras
disposed on the retractor and directed into the surgical site; one
or more illumination devices configured to illuminate the surgical
site; and an image processing system that receives the video images
of the surgical site; broadcasting the video images to the image
processing system; and presenting a three-dimensional type picture
based on the video images to a surgeon.
12. The method of claim 11, wherein the broadcasting the video
images step is performed by a wireless transmitter associated with
the one or more cameras.
13. The method of claim 11, wherein the three dimensional-type
picture is free of field-flattening effects.
14. The method of claim 11, wherein the one or more cameras is
encircled by one or more LED illumination devices.
15. The method of claim 11, wherein the one or more illumination
devices is attached to the retractor by way of a flexible
sleeve.
16. The method of claim 15, wherein the one or more cameras is
attached to the retractor by way of a flexible sleeve.
17. The method of claim 11, wherein the one or more illumination
devices are comprised of fiber optic strands or bundles for
transmitting light into the surgical site, the one or more
illumination devices disposed within a wall thickness of the
surgical retractor.
18. The method of claim 11, wherein the one or more illumination
devices comprise LEDs.
19. The method of claim 11, wherein the one or more cameras is a
CMOS or CCD camera.
20. A surgical visualization system comprising: a surgical
retractor configured to hold open an incision and thereby provide a
pathway for access of surgical tools to a surgical site, said
retractor comprising portions configured to be disposed about an
open region located between said retractor portions so as to permit
access of surgical tools to the surgical site through said open
region; one or more cameras configured to acquire and transmit
video images of the surgical site, the one or more cameras disposed
on the retractor and directed into the surgical site, the one or
more cameras comprising at least one of CCD and CMOS cameras; one
or more illumination devices configured to illuminate the surgical
site, the one or more illumination devices encircling the one or
more cameras; and an image processing system that receives the
video images of the surgical site; wherein: said retractor has
proximal and distal ends, said distal end closer to said surgical
site than said proximal end; the one or more cameras is disposed at
the distal end of the retractor by way of a flexible sleeve; and
the image processing system presents a three-dimensional type
picture based on the video images to a surgeon, the three
dimensional-type picture free of field-flattening effects.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 15/664,417, filed Jul. 31, 2017, which is a
continuation of U.S. patent application Ser. No. 14/519,880, filed
Oct. 21, 2014 (now U.S. Pat. No. 9,717,403, issued Aug. 1, 2017),
which is a continuation-in-part of U.S. patent application Ser. No.
13/091,024 filed Apr. 20, 2011 (now U.S. Pat. No. 8,864,654, issued
Oct. 21, 2014), entitled "Method and Apparatus for Performing Retro
Peritoneal Dissection" and claims the benefits of and priority,
under 35 U.S.C. .sctn. 119(e), to U.S. Provisional Application Ser.
No. 61/326,138, filed Apr. 20, 2010, entitled "Method and Apparatus
for Performing Retro Peritoneal Dissection."
[0002] The present application is a continuation of U.S. patent
application Ser. No. 15/664,417, filed Jul. 31, 2017, which is a
continuation of U.S. patent application Ser. No. 14/519,880, filed
Oct. 21, 2014 (now U.S. Pat. No. 9,717,403, issued Aug. 1, 2017),
which is a continuation-in-part of U.S. patent application Ser. No.
14/507,367, filed on Oct. 6, 2014, entitled "Apparatus and Method
of Spinal Implant and Fusion," which is a continuation of Ser. No.
13/754,042, filed on Jan. 30, 2013 (now U.S. Pat. No. 8,870,882,
issued Oct. 28, 2014), which is a continuation of Ser. No.
12/632,720, filed on Dec. 7, 2009 (now U.S. Pat. No. 8,366,748,
issued on Feb. 5, 2013), and which claims priority from provisional
patent application No. 61/186,683, filed Jun. 12, 2009; as well as
provisional patent application No. 61/120,260, filed Dec. 5,
2008.
[0003] The present application is a continuation of U.S. patent
application Ser. No. 15/664,417, filed Jul. 31, 2017, which is a
continuation of U.S. patent application Ser. No. 14/519,880, filed
Oct. 21, 2014 (now U.S. Pat. No. 9,717,403, issued Aug. 1, 2017),
which is a continuation-in-part of U.S. patent application Ser. No.
12/965,654, filed on Dec. 10, 2010, entitled "Lateral Based
Retractor System", which is a non-provisional patent application
which claims the benefit of priority from commonly owned and
co-pending U.S. Provisional Application Nos. 61/262,075, filed Dec.
10, 2009, and 61/323,984, filed Apr. 14, 2010. The entire contents
of all of the above-referenced patent applications are hereby
expressly incorporated by reference in this disclosure as if set
forth fully herein.
FIELD OF THE INVENTION
[0004] This disclosure relates to human surgical procedures
performed percutaneously, and more specifically to a novel
retractor, neuro-monitoring probe and progressive cannula system
that enhances illumination and visibility. The disclosure also
relates to a system and method for providing one or more disposable
or reusable camera/video devices, including camera/video devices
incorporating CCD and/or CMOS technology.
BACKGROUND OF THE INVENTION
[0005] Surgical procedures to address illness, disease or injury
vary depending on a number of factors, including the ability of the
surgeon(s) to access and perform the necessary procedures at the
affected site. As one example, individuals who suffer degenerative
disc disease, natural spine deformations, a herniated disc, spine
injuries or other spine disorders often require surgery on the
affected region to relieve pain or prevent further injury to the
spine and nerves. Spinal surgery may involve removal of damaged
joint tissue, insertion of a tissue implant and/or fixation of two
or more adjacent vertebral bodies. These procedures are often
difficult due to the location of the spine and adjacent nerves,
sensitive anatomy, etc. The surgical procedure will vary in
approach and duration depending on the nature and extent of the
injury.
[0006] One particular type of spinal surgery is referred to as
"fusion." Fusion of vertebral bodies involves fixation of two or
more adjacent vertebrae. This procedure may be performed through
introduction of rods or plates, and screws or other devices into a
vertebral joint to join various portions of a vertebra to a
corresponding portion on an adjacent vertebra. Fusion may occur in
the lumbar, interbody or cervical spine region of a patient. A
fusion is designed to stop and/or eliminate all motion in the
spinal segment by destruction of some or all of the joints in that
segment and further utilizing bone graft material and/or rigid
implantable fixation devices for securing the adjacent vertebrae.
By eliminating movement, back pain and further degenerative disc
disease may be reduced or avoided. Fusion requires tools for
accessing the vertebrae, such as surgical cannulae for
"minimally-invasive" surgical procedures, and other tools for
implanting the desired implant, bioactive material, etc. Such
procedures often require introduction of additional tools to
prepare a site for implantation. These tools may include drills,
drill guides, debridement tools, irrigation devices, vises, clamps,
cannula, and other insertion/retraction tools.
[0007] Spinal surgeries may be performed by a number of different
"minimally-invasive" procedures, as opposed to conventional
surgical procedures and methods, which typically require cutting of
muscles, removal of bone, and retraction of other natural elements.
With minimally invasive spinal surgery, a less destructive approach
to the spine is carried out by using portals, which take advantage
of anatomy and current technology to limit the damage to
intervening structures.
[0008] Typically, skeletal landmarks are established
fluoroscopically and a small incision is made over the landmark(s).
According to methods known in the prior art, a series of dilators
are applied until one or more cannula is placed over the anatomic
structure. A microscope is then placed over the operative site. The
microscope provides illumination and magnification with a three
dimensional view of the anatomical site. While this process
provides substantial advantages relative to open surgery, it
requires the use of an operating microscope. This particular piece
of equipment is extremely expensive (most quality brands are in the
$250,000 range). The microscope is an unwieldy device requiring
uncomfortable gyrations of the surgeon's back and neck in order to
gain the necessary view and is a nuisance to drape (a large,
sterile plastic bag has to be placed over the eight foot tall
structure). The illumination is also difficult to direct due to the
size of the microscope.
[0009] A significant danger of performing intervertebral operations
or accessing an intervertebral space during spine surgery is that
of inadvertently contacting or damaging the para-spinal nerves,
including the exiting nerve roots, traversing nerves and the nerves
of the cauda equina. The exact location of these para-spinal nerves
cannot be determined prior to the commencement of surgery, and
therefore are dependent on a surgeon's ability to visually locate
the same after the initial incision is made. Moreover,
intervertebral spaces in the spine have other sensitive nerves
disposed at locations which are not entirely predictable prior to
insertion of the surgical tool into the intervertebral area.
Accordingly, the danger of pinching or damaging spinal nerves when
accessing an intervertebral space has proven to be quite limiting
to the methods and devices used during minimally invasive spinal
surgery. In addition, as cannula are received through the patient's
back, such as when performing minimally invasive spinal surgery,
minor blood vessels are ruptured, thereby blocking the surgeon's
vision inside the intervertebral region after the cannula has been
inserted. Other anatomical features at a particular patient may
also destruct the surgeon's view or make it difficult to provide
illumination within the cannula.
[0010] Lateral based spinal surgery is a known alternative to
conventional surgical procedures, and is generally referred to as a
"minimally-invasive" procedure. Lateral based procedures offer the
advantages of shorter recovery times, reduced blood loss, reduced
post-operative complications, and shorter operating times than
conventional procedures and methods. For example, one surgical
approach for spinal fusion using a minimally invasive technique is
known as "lumbar interbody fusion" or LIF for short. Other known
examples of lateral based approaches include the Nuvasive XLIF
procedure and Medtronic D-LIF System. However, these systems and
methods have problems and shortcomings, including, but not limited
to, limited visualization and lighting in the surgical area,
increased risk of impinging upon the nerves of the lumbosacral
plexus, and the ilioinguinal and genitofemoral nerves and the risk
of devices and/or instruments becoming dislodged during the various
procedures, among others. These problems, alone or in combination,
may result in post-operative pain and discomfort experienced by
patients of lateral based spinal surgery. In some instances, these
problems require or otherwise lead to additional surgeries, further
complicating the likelihood of recovery and successful fusion.
[0011] Various devices and surgical access systems are known in the
art to facilitate minimally invasive surgical procedures while
allowing for a sufficiently large surgical area. These devices may
include a series of tools which, when consecutively inserted, serve
to gradually expand an area, including cannula. Retractors are
useful for gradually dilating the area of an incision or surgical
opening in order to form a desired amount of space within which
various procedures may be conducted. Retractors may take the form
of a single device that may be inserted into a work area and
expanded at the direction of a user, thus allowing for the creation
and maintaining of a surgical work space. Many retractors fail to
provide independent illumination sources or allow the surgeon to
visualize the path of access to the surgical site. As these
retractors are often the first (or one of the first) tools used in
the procedure, providing adequate illumination and enhancing
visualization are important to the success of the operation. Thus,
there is a present felt need for an improved retractor with
enhanced illumination that otherwise improves the visibility for
the surgeon, and for a method of retrofitting an existing retractor
with apparatus to accomplish this objective.
[0012] Other problems experienced in minimally invasive surgical
procedures include the risk of injury caused during the initial
probing and dissecting of tissue between the incision and the
surgical site. Typically, such probing is done using a finger or a
slender dilator or other tool, which is used to navigate through
the soft tissue, anatomy, and ultimately reach the desired point of
access to the surgical site. During this probing, there is
increased risk to injury to the lumbar plexus, particularly when
the surgeon is attempting to access the lumbar spine. In addition,
there is also an increased risk to the patient's anatomy, and to
undesired dissection of various anatomical features between the
incision and the surgical site. This risk of injury typically
increases as the probe is inserted deeper into the body of a
patient, and continues after the probe has been fully inserted and
continuing through dilation, such as by inserting one or more
progressive surgical cannula around the dilator proceeds. Damage to
the peritoneal membrane, colon perforation, ureteral or great
vessel injury can be the result of the "blind" dissection and is
major reason why the lateral, transpoas approach is not a more
commonly performed surgical procedure. Thus, there is a deep felt
need in the art to mitigate these potentially catastrophic
complications, and to address the other problems associated with
performing these procedures in a "blind" manner.
[0013] Typically, as these processes for accessing the surgical
site are done blind (i.e., without vision of where the probe is
directed), it is not uncommon that the probing instrument(s)
intersect and/or dissect the patient's anatomy, intercept nerves,
sensitive tissue, rupture arteries, etc. Thus, there is also a need
for an improved tool for initially dilating and accessing the
tissue between the incision and the surgical site. There is a
further need for an improved system and method for providing a
surgeon with visibility of this area, to assist with the navigation
through the tissue, anatomy, etc. and to provide enhanced
illumination for a minimally invasive surgical procedure.
[0014] The disclosure of the invention herein addresses these and
other problems by providing a system and method for achieving an
endoscopic approach to a surgical site, coupled with the use of a
unique illumination and video capability. The system of the
invention is preferably achieved by incorporating a camera chip in
the apparatus of the system, thereby obviating the need and
disadvantages of the operating microscope and other expensive and
cumbersome instrumentation. These and other considerations are
addressed by the present disclosure in more detail in the Summary
and Detailed Description.
SUMMARY OF THE INVENTION
[0015] Incorporated by reference in their entireties are the
following U.S. patents and patent applications directed generally
to methods and apparatus related to spinal procedures, thus
providing written description support for various aspects of the
present disclosure. The U.S. patents and pending applications
incorporated by reference are as follows: U.S. Pat. No. 7,406,775
to Funk, et al.; U.S. Pat. No. 7,387,643 to Michelson; U.S. Pat.
No. 7,341,590 to Ferree; U.S. Pat. No. 7,288,093 to Michelson; U.S.
Pat. No. 7,207,992 to Ritland; U.S. Pat. No. 7,077,864 Byrd III, et
al.; U.S. Pat. No. 7,025,769 to Ferree; U.S. Pat. No. 6,719,795 to
Cornwall, et al.; U.S. Pat. No. 6,364,880 to Michelson; U.S. Pat.
No. 6,328,738 to Suddaby; U.S. Pat. No. 6,290,724 to Marino; U.S.
Pat. No. 6,113,602 to Sand; U.S. Pat. No. 6,030,401 to Marino; U.S.
Pat. No. 5,865,846 to Bryan, et al.; U.S. Pat. No. 5,569,246 to
Ojima, et al.; U.S. Pat. No. 5,527,312 to Ray; and 2008/0255564 to
Michelson. These references assist in explaining the current state
of the art for surgical instruments generally, and provide
additional written support for the various apparatus and methods
described herein.
[0016] According to one particular embodiment of the present
disclosure, the invention involves the use of a disposable cannula
of variable lengths, which are applied over the dilator tools.
These cannulas can have a variety of shapes depending upon the
surgical requirement. Ovoid, egg-shaped or round cannulas are
contemplated and may further comprise an angled working edge as
described in greater detail herein. The devices described herein
are unique in that they have incorporated a source of illumination,
preferably attached to the walls of the cannula, which emit light
to the base of the portal and enhance illumination within the
cannula.
[0017] According to yet another aspect of the present disclosure, a
modified retractor according to various embodiments is described
that incorporates illumination and/or video capabilities. The
modified retractor cooperates with cannula described in greater
detail below to permit a surgeon to avoid nerves, aberrant vessels
and other anatomical features such as the kidney, ureter,
peritoneal membrane, etc. According to one embodiment, the
retractor includes an extension or "periscope" feature that moves
longitudinally along the shaft of the blade of the retractor to
exclude retroperitoneal fat or other tissue that otherwise obscures
the view of the surgeon along the outer surface of the blade of the
retractor, where one or more cannula may be mounted.
[0018] According to one embodiment of the disclosure, the
illumination is provided by way of fiber optic strands or bundles.
The fiber optics can run circumferentially or along one or more
walls of the cannula, and preferably terminate at least a
centimeter from the bottom of the device. This prevents the
illumination from "bottoming out" at the floor of the incision.
Additionally, the light fibers may be fashioned in an annulus
around a camera chip device to provide illumination to the surgical
site where images are being captured by the camera chip device. In
still another embodiment, the light fibers may be replaced by one
or more LEDs in a remote light source or at the distal-tip of the
camera chip device. The light source may come from an external
device such as a headlight lamp, or a standard-type light source
commonly found in operating rooms which plugs into an adaptor on
the disposable cannula.
[0019] According to embodiments described herein, the system
comprises a disposable cannula that has at least one slot through
which the camera chip device(s) can be passed and inserted on a
composite insert, which preferably fits in a tongue and groove
fashion down the slot of the cannula. The camera chip device may
have associated wide-angle optics and its composite insert can be
easily removed/adjusted during the course of the operation for
cleaning or when the cannula needs to be re-directed or reoriented
during the course of the surgery.
[0020] The camera chip device, which according to a preferred
embodiment is based on either CCD or CMOS technology, may have the
necessary video-processing circuitry onboard the camera chip device
housing, or the video-processing circuitry may be housed
separately, several meters away from the camera chip device, and
connected by a cable or alternatively via wireless transmission.
For further details on the type of camera chip device according to
a preferred embodiment of the present disclosure, applicant hereby
incorporates by reference in its entirety the disclosure of U.S.
Pat. No. 6,310,642.
[0021] According to one embodiment, an apparatus and method and
provided whereby, instead of the surgeon viewing the operative site
through the oculars of the microscope, the anatomy is presented on
a screen in front of him (or her) and in front of the assistant(s).
Due to the camera chip device and associated optics housing being
placed directly at the operative site, the image collected is free
from the distortions and the "field-flattening" effects found when
using complex optical stacks commonly found in operating
microscopes and endoscopes. This results in a significant increase
in "depth-cues" and color-reproduction and in turn improves
visibility. The camera technology provides a three dimensional-type
picture to the surgeon with enhanced illumination, and without the
extra costs of adding a second camera device and expensive
intra-ocular optical orientations. The costs of the microscope and
its maintenance, plastic draping, sterility/contamination issues
and surgeon fatigue are either eliminated or at least substantially
reduced.
[0022] According to yet another embodiment of the present
disclosure, a tool is provided that comprises at least one CMOS or
CCD video imaging device, which permits a user to view images
captured by the CMOS or CCD imaging device of the disc space or
other surgical area to be operated on. For example, one or more
angled tools may incorporate a video insert (described in greater
detail below), for capturing and viewing images of the
intervertebral disc space during or after dissection has occurred.
This may be accomplished by providing a CMOS or CCD camera device
at the distal end of the one or more angled tools, and either
wirelessly or hardwire transmitting the images captured by that
CMOS or CCD camera to a display. As one other example, one or more
scraping or debridement tools may incorporate the video insert
described in greater detail below, for capturing and viewing images
of the intervertebral disc space after and during dissection. This
capacity allows for a more complete and safe disc space
preparation. A more precise carpentry of the disc space allows for
an increased potential for fusion and a reduction of vertebral
endplate or soft tissue injury. This may be accomplished by
providing a CMOS or CCD camera at the distal end of the one or
debridement tools, and either wirelessly or hardwire transmitting
the images captured by that CMOS or CCD camera to a display.
[0023] One having skill in the art will appreciate that the
apparatus described herein, according to various embodiments of the
present disclosure, may have various sizes. The sizes of the
various elements of embodiments of the present disclosure may be
sized based on factors including, for example, the anatomy of the
patient, the person operating the apparatus, the surgical site
location, physical features of any implanted device required with
the surgical procedure, including, for example, width, length and
thickness, and the size of the drill or other surgical tool being
used with the apparatus, and other factors.
[0024] According to one embodiment, the illumination and
camera/video capabilities described herein may be provided with one
or more cannula having a shape other than round (e.g., oval,
pointed, square cornered, egg-shaped etc.) and having an end (e.g.,
the end inserted into the patient, distal from the user) that is
angled and/or tapered and/or shaped to be ideally seated in a
particular surgical site. Asymmetrical cannulas may allow
visualization of the facet joint of the spine, for example. An
"egg-shaped" cross section may allow for the best view of the facet
joint and further minimizes the medial-lateral dissection that a
round cannula would require. Such shapes are specifically
contemplated for incorporating the illumination and camera/video
apparatus described herein.
[0025] Still other aspects of the invention are directed to cannula
instruments that have a patient contacting end that is adjustable
to assume a predetermined conformation. Thus, in one embodiment,
material forms the end that comes into contact with bone, tissue,
and especially as it nears nerve tissue, with such cannula end
material being malleable to an extent necessary for the surgeon to
mold the end such that it achieves the desired contours or avoids
particular structures encountered in any particular surgery. By way
of example but not limitation, if a bony outcropping, a nerve
fiber, etc. is perceived by the surgeon, the cannula tip end can be
adjusted to avoid undesired contact or interference with such
tissues or structures.
[0026] In particular embodiments, the ability to adjust the
geometric parameters of the cannula end may be achieved by
manipulation of the other end of the instrument. For example,
providing a turnable component at the opposite end of the
instrument, the shape of the other end of the instrument (i.e. the
end inserted into the patient) can be adjusted to either expand
circumference, reduce circumference, render the opening more or
less oblong, etc. In such a manner, it is possible to avoid having
to remove the instrument or cannula from the patient's site to
adjust the morphology of the instrument, thus saving time, avoiding
undesired reinsertion procedures, etc.
[0027] According to another embodiment of the present disclosure, a
system is provided wherein the cannula further include one or more
electrical probes at the exit portal, which are adapted to assist
the surgeon in identifying the presence and location of nerves as
the probe is advanced during minimally-invasive surgery, thereby
providing further assistance and feedback for guiding the path of
the cannula and other surgical instruments to be inserted into the
surgical site.
[0028] An expandable tip cannula or dilator may be provided, which
functions both as an access portal for surgery and as a system for
nerve surveillance, such that the presence and relative position of
para-spinal nerves, for example, can be detected as the expandable
tip cannula is inserted through the patient's facia and
musculature. One particular advantage of determining the position
of the lumbosacral plexus with respect to the distal tip of the
cannula/dilator is that the lumbosacral plexus can be avoided or
gently moved out of the surgeon's way while inserting the
cannula/dilator.
[0029] According to one embodiment, the present disclosure provides
a system of cannulas adapted to assist the surgeon in guiding the
path of surgical instruments received into the intervertebral
space, while identifying the presence and location of para-spinal
nerves as the cannula is advanced to a patient's intervertebral
space during minimally invasive surgery. In various aspects of the
present disclosure, probes of the type described in greater detail
herein may be comprised of one or more electrodes powered at a low
level to sense the position of a para-spinal nerve through
continuous real time electromyographic monitoring. Alternatively,
these electrodes can be powered at a higher level such that they
operate to cauterize blood vessels. Safety systems ensure that
power levels sufficient to cause cauterization are not activated if
a nerve is sensed to be near the electrodes at the distal end of
the cannula.
[0030] According to yet another embodiment of the present
disclosure, a system is provided where the cannula or dilator
further include one or more electrical probes at the exit
portal/patient contacting end, which are adapted to assist the
surgeon in identifying the presence and location of nerves as the
probe is advanced during minimally-invasive surgery, thereby
providing a device for guiding the path of other surgical
instruments to be inserted into the intervertebral space.
[0031] According to one embodiment, the present disclosure provides
a system of cannulas adapted to assist the surgeon in guiding the
path of surgical instruments received into an intervertebral space,
while identifying the presence and location of para-spinal nerves
as the cannula is advanced to a patient's intervertebral space
during minimally invasive surgery. In various aspects of the
present disclosure, the system of cannulas may further comprise of
one or more electrodes powered at a low level to sense the position
of the nerves of the lumbo-sacral plexus through continuous real
time electromyographic monitoring. Alternatively, these electrodes
can be powered at a higher level such that they operate to
cauterize blood vessels. Safety systems ensure that power levels
sufficient to cause cauterization are not activated if a nerve is
sensed to be near the electrodes at the distal end of the
cannula.
[0032] One having skill in the art will appreciate that embodiments
of the present disclosure may be constructed of materials known to
provide, or predictably manufactured to provide the various aspects
of the present disclosure. These materials may include, for
example, stainless steel, titanium alloy, aluminum alloy, chromium
alloy, and other metals or metal alloys. These materials may also
include, for example, PEEK, carbon fiber, ABS plastic,
polyurethane, rubber, latex, synthetic rubber, and other
fiber-encased resinous materials, synthetic materials, polymers,
and natural materials.
[0033] One having skill in the art will appreciate that embodiments
of the present disclosure may be controlled by means other than
manual manipulation. Embodiments of the present disclosure may be
designed and shaped such that the apparatus may be controlled, for
example, remotely by an operator, remotely by an operator through a
computer controller, by an operator using proportioning devices,
programmatically by a computer controller, by servo-controlled
mechanisms, by hydraulically-driven mechanisms, by
pneumatically-driven mechanisms or by piezoelectric actuators.
[0034] The Summary of the Invention is neither intended nor should
it be construed as being representative of the full extent and
scope of the present disclosure. The present disclosure is set
forth in various levels of detail in the Summary of the Invention
as well as in the attached drawings and the Detailed Description of
the Invention and no limitation as to the scope of the present
disclosure is intended by either the inclusion or non-inclusion of
elements, components, etc. in this Summary of the Invention.
Additional aspects of the present disclosure will become more
readily apparent from the Detailed Description, particularly when
taken together with the drawings.
[0035] The above-described benefits, embodiments, and/or
characterizations are not necessarily complete or exhaustive, and
in particular, as to the patentable subject matter disclosed
herein. Other benefits, embodiments, and/or characterizations of
the present disclosure are possible utilizing, alone or in
combination, as set forth above and/or described in the
accompanying figures and/or in the description herein below.
Further details and description of embodiments of the present
disclosure are provided in the Appendix A to this application.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] The present disclosure relates to systems and methods for
accessing intervertebral space and facilitating the use of surgical
tools and inserting spine implants between vertebral bodies. Those
of skill in the art will recognize that the following description
is merely illustrative of the principles of the disclosure, which
may be applied in various ways to provide many different
alternative embodiments. This description is made for illustrating
the general principles of the teachings of this disclosure
invention and is not meant to limit the inventive concepts
disclosed herein.
[0037] The accompanying drawings, which are incorporated in and
constitute a part of the specification, illustrate embodiments of
the disclosure and together with the general description of the
disclosure given above and the detailed description of the drawings
given below, serve to explain the principles of the
disclosures.
[0038] FIG. 1 is a perspective view of a modified retractor
according to one embodiment of the present disclosure; and
[0039] FIG. 2 is another perspective view of the modified retractor
of FIG. 1;
[0040] FIG. 3 is a conceptual diagram of the modified retractor of
FIG. 1 with a means for providing illumination at or near the
distal end of the modified retractor;
[0041] FIG. 4 is a conceptual diagram of the modified retractor of
FIG. 1 mating with a semi-circular cannula and having enhanced
illumination for improving visibility within the cannula;
[0042] FIG. 5 is a side sectional view of a dilator that includes a
neuro-monitoring lead that extends from the body of the dilator,
illumination means, and at least one other lumen for a camera
device according to one embodiment of the present disclosure;
[0043] FIG. 6 shows a cross-sectional view of the dilator of FIG.
5;
[0044] FIG. 7 is a perspective view of a cannula according to a
preferred embodiment of the present disclosure;
[0045] FIG. 8 is a perspective view of an interlocking cannula with
the cannula of FIG. 7;
[0046] FIG. 9 is a cross-sectional view of the cannula shown in
FIG. 8;
[0047] FIG. 10 is a view of the cannula of FIG. 9 in a docked
view;
[0048] FIG. 11 is a perspective view of a cannula with at least one
channel for inserting an anchoring device and at least one slot for
mating with an illumination and/or video insert according to one
embodiment of the present disclosure;
[0049] FIG. 12 is a perspective view of the cannula of FIG. 11 and
the cannula of FIG. 7;
[0050] FIG. 13 is a perspective view of the cannula of FIG. 12 in a
docked view;
[0051] FIG. 14 includes a cross-sectional view of the cannula,
according to one alternative embodiment, with LED illumination
devices and a CMOS/CCD camera slot, and a top plan view of the
cannula according to this embodiment;
[0052] FIG. 15 is a detailed cross-sectional view of the cannula
shown in FIG. 14;
[0053] FIG. 16 is a perspective view of the cannula according to
one embodiment with a hardwired CMOS/CCD camera device insert;
[0054] FIG. 17 is a detailed perspective view of the CMOS/CCD
camera insert according to FIG. 16 with a fiber optic array;
[0055] FIG. 18 includes perspective views of a cannula, according
to another alternative embodiment, with and without the CMOS/CCD
camera insert; and
[0056] FIG. 19 is a perspective view of a dilator tool according to
one alternative embodiment of the present disclosure.
[0057] FIGS. 20A-20F are various views of a surgical cannula and
dilators that are used in conjunction with certain embodiments of
the present disclosure;
[0058] FIG. 21 is a cross-sectional view of various features of the
present invention;
[0059] FIG. 22 is a cross-sectional illustration of a patient
illustrating features and operation of the present invention;
[0060] FIG. 23 is a perspective view of a cannula and working
cannula according to one embodiment of the present invention;
[0061] FIG. 24 is a cross-sectional illustration of a patient
illustrating features and operation of the present invention;
and
[0062] FIG. 25 is a cross-sectional illustration of a patient
illustrating features and operation of the present invention.
[0063] It should be understood that the above-referenced drawing
figures are not necessarily to scale. In certain instances, details
that are not necessary for an understanding of the disclosure or
that render other details difficult to perceive may have been
omitted. It should be understood, of course, that the disclosure is
not necessarily limited to the particular embodiments illustrated
herein.
DETAILED DESCRIPTION
[0064] Various embodiments of the apparatus and methods of the
present disclosure are described in detail below. The following
patents are hereby incorporated by reference for the express
purpose of describing the technology related to the use of
illumination and video capabilities described herein, including the
use of camera chips and CCD or CMOS technology: U.S. Pat. Nos.
6,310,642; 6,275,255; 6,043,839; 5,929,901; 6,211,904; 5,986,693;
and 7,030,904.
[0065] Referring now to FIGS. 1-4, a modified retractor according
to embodiments of the present disclosure is shown, which
incorporates illumination and/or video capabilities of the nature
described herein. This "Sherrill" retractor comprises a
longitudinal blade, which extends longitudinally a length
sufficient for inserting into a patient to assist in retracting
tissue between the incision and the surgical site, and may
incorporate one more lumens internal to the blade for providing
illumination means and/or CMOS or CCD video capabilities. This
"Sherrill" retractor may alternatively be used, or used in
connection with the dilator or wand described below in connection
with FIGS. 5-6. Further details of this modified retractor are
provided below.
[0066] FIG. 1 is a perspective view of the modified retractor 1
according to one embodiment of the present disclosure. The modified
retractor 1 comprises a handle 3 and a generally planar blade 5
that has a length sufficient to reach a variety of surgical sites.
The retractor 1 may further comprise one or more visual landmarks 7
along the length of the blade 5 as shown in FIGS. 1 and 2.
According to one embodiment, the handle 3 may be detachable from
the blade 5 and may also be substantially hollow for housing a
power source, such as a battery, as described in further detail
below in connection with FIG. 3.
[0067] FIG. 2 depicts another perspective view of the modified
retractor 1 of FIG. 1. In a preferred embodiment, the blade 5 of
the modified retractor (such as the one shown in FIG. 4) comprises
two thin edges formed along at least a portion of the sides of the
blade 5, which are convenient for use in attaching a semi-circular
or semi-oval shaped cannula (shown in FIG. 4 as 25) by sliding the
cannula over the two thin edges of the blade 5. Thus, according to
one embodiment shown in FIG. 4, a cannula 25 is provided with two
corresponding grooves or lips 27 along the surface of the cannula
body, and oriented to couple with the two thin edges of the
modified retractor.
[0068] In this manner, a surgeon using the modified retractor may
first insert the retractor, retract any tissue and other anatomical
features between the incision and the surgical site, and then
attach the cannula 25 by sliding the cannula 25 along the two thin
edges in a longitudinal direction relative to the blade 15 of the
retractor. In another embodiment, the two thin edges may have
slightly raised surfaces or bosses for facilitating this attachment
via a tongue and groove connection. In one embodiment, the handle
13 of the modified retractor extends in generally the same
direction as the blade 15 of the modified retractor, or is offset
from the plane of the blade by an angle less than 90 degrees to
facilitate this interconnectivity between the modified retractor
and the cannula described above.
[0069] According to one embodiment of the present disclosure, a
method is disclosed whereby the dissecting finger is followed by
this modified "Sherrill" retractor, which preferably incorporates
one or more light emitting diodes 19 at its distal end as shown in
FIG. 3, and a handle 13 containing the LED power source. According
to this method, as the surgeon advances his blunt finger dissection
of the retroperitoneal space, the Sherrill retractor 11 follows the
finger with a visible path preventing inadvertent damage to intra-
and retroperitoneal structures. The Sherrill retractor 11 is
preferably modified to incorporate one or more camera devices (such
as CMOS camera chips) at its contacting end and secured within a
housing for allowing safe, visual placement through the dissected
retroperitoneal space. This technique and associated apparatus
shown in FIGS. 1-4 may be particularly useful for a surgeon
attempting placement of the retractor onto the psoas muscle while
avoiding the ilioinguinal and genitofemoral nerves on the surface
of the muscle.
[0070] According to one embodiment, a flexible sleeve may be
fabricated to fit over the body of an existing retractor or
distractor device and incorporate the lumens or channels for
inserting one or more fiber optic strands or bundles, and may also
include a slot for inserting a camera insert such as the type
described above. Therefore, existing retractors and distracters
manufactured by various parties such as Medtronic and Nuvasive may
incorporate the concepts of the present disclosure despite having
no prefabricated lumens or slots for accommodating the necessary
illumination and/or video capabilities discussed herein.
[0071] FIGS. 5-6 show a specific dilator or "wand" according to one
preferred embodiment, which may be used for achieving the
objectives described herein. In this embodiment, the dilator or
wand 29 has a generally ovoid cross-sectional shape and is
sufficient in size to accommodate a plurality of lumens, through
which a CMOS or CCD camera insert 31 and/or illumination means 35
such as one or more light emitting diodes may be incorporated.
According to a preferred embodiment, the dilator or wand 29
comprises at least one lumen 33 which extends beyond the length of
the generally ovoid section of the dilator or wand, which may be
used in a tapering configuration (and according to one alternative
embodiment, a telescoping configuration) for gently probing through
tissue, achieving vision (via CMOS or CCD video technology) of the
anatomy through which the surgeon must navigate prior to securing
the cannula to the surgical site, etc. In this embodiment, the
dilator or wand 29 also comprises a lumen 33 through which one or
more conductive materials may be inserted for stimulation of the
various nerves of the psoas. This dilator 29 may also house
illumination means 35, such as fiber optic strands and/or LED
devices, for allowing a light source at the useable end of the
dilator or wand 29.
[0072] In use, this enhanced dilator 29 allows the surgeon to have
direct visualization and illumination of the retroperitoneal space,
and allows simultaneous stimulation of the psoas or other spinal
nerves, via one or more electrical probes which are incorporated
into one of the plurality of lumens of the dilator 29. This dilator
29 therefore serves as a guide, which allows the surgeon to safely
and securely reach the surgical site without causing damage to any
of the patient's anatomy, and continue with application of
progressively larger dilators and working cannula (including those
described herein) without causing injury to the patient.
[0073] The dilator 29 may vary in length, according to the patient
and the unique anatomy presented for the surgical operation.
According to a preferred embodiment, the length dilator 29 is in
the range of 50-500 millimeters in length, and the diameter is
approximately 2-10 millimeters. The material of the dilator 29 is
preferably selected from the group consisting of aluminum, iron,
titanium, steel, stainless steel, surgical stainless steel of the
general alloy type of iron, carbon, chromium (12-20%) molybdenum
(0.2-3%) and nickel (8-12%), martensitic steel, grade 316L
austenitic steel, grade 316LVM austenitic steel, grade 316
stainless steel, medical grade plastic and PEEK.
[0074] According to one embodiment of the present disclosure, the
same distal end of the dilator 29 that comprises a CCD or CMOS
video device 31 further comprises a conductive material, which is
capable of transmitting signals, such as neurological signals to a
measuring device for detecting one or more nerves in-between the
incision and the surgical site. This distal neuro-monitoring tip
may be made of a variety of different conductive materials,
including but not limited to copper, brass, aluminum, metal alloy,
inherently conductive polymers or any of the known polymers having
a conductive filler, such as metal fillers, metal-cooled glass
and/or carbon fiber fillers.
[0075] One or more CCD or CMOS camera devices 31 located at the
distal end of the dilator 29 may be surrounded by a lens, and the
lens made of a conductive glass, wherein the conductivity of the
device and the lens of the device are accomplished in a single
integrated apparatus. According to a preferred embodiment, the
distal end of the dilator 29 is generally ovoid in shape and
provides for a compound radii, which further assists in moving soft
and often sensitive tissue away from the tip of the dilator as it
is inserted into the patient. Similarly, the conductive material at
the distal tip of the dilator 29 is preferably ovoid, and permits
material to be moved gently away from the device at is progressed
deeper into the incision.
[0076] According to various embodiments, the dilator 29 further
comprises one or more fiber optic fibers which extend
longitudinally down the shaft of the dilator for providing
illumination. According to one embodiment, the one or more strands
are positioned proximate to the CCD or CMOS video device 31, such
that the CCD or CMOS video device 31 has adequate illumination for
capturing images at the distal end of the dilator 29. This
illumination also allows a surgeon to achieve adequate
visualization, both with the naked eye and through images captured
by the CCD or CMOS video device 31. In an alternate embodiment, the
illumination is proved by one or more LED devices adjacent the CCD
or CMOS video device 31.
[0077] Referring again to the drawing figures, according to one
embodiment, the dilator 29 may be comprised of a generally
cylindrical body, having a generally ovoid cross-section as shown
in FIG. 6, and may incorporate multiple lumens extending
therethrough. One or more internal lumens may incorporate the fiber
optic illumination strands and/or the CCD or CMOS video device,
while the second lumen may provide a channel for receiving signals
via the conductive material at the distal end of the dilator. This
second lumen may alternately serve as a guide for wire anchors to
be positioned from the end opposite the CCD or CMOS video device,
which allow the surgeon to insert, for example, 0.0625 inch K-wire
or other suitable wire or fastening device to secure to the disc
space.
[0078] According to the embodiment shown in the drawing FIGS. 5-6
and particularly in the alternate embodiment shown in FIG. 19, the
illumination and CCD or CMOS camera device may extend a distance
beyond the generally cylindrical body of the dilator, such that the
illumination and video device precede the navigation of the
generally cylindrical body of the dilator, thereby permitting the
surgeon to see and illuminate tissue, sensitive anatomy, etc. prior
to impact by the dilator.
[0079] In use, a method of retro peritoneal dissection involves
using one or more slender video dilators to gently probe through
the incision and to view the images captured by the CCD or CMOS
video device located on or near the distal end of the one or more
slender dilators. As the surgeon encounters sensitive anatomical
features, such as the patient's intestine, images of those
anatomical features will become apparent to the surgeon via the
display. The images of other anatomical features are also captured
by the CCD or CMOS video device during dissection and insertion of
the one or more slender dilators.
[0080] If certain anatomical features cannot be moved from the path
of the dilator, the approach of the surgeon may be adjusted
accordingly, and the dilator inserted around these features to
avoid undesired dissection. This in turn allows the surgeon to view
the path to the disc space, achieve the desired approach and insure
that any further instrumentation or apparatus that are inserted
through the incision do not encounter the sensitive anatomical
features of the patient, and further insure that the cannula are
properly seated adjacent the disc space.
[0081] Once the slender dilator has been inserted through the
sensitive anatomy of the patient and approaches the desired
surgical cite, the surgeon can further use the images captured from
the CCD or CMOS video device to find the desired location of the
disc space where the operation will proceed, dissection of the disc
space will occur, etc. According to one embodiment, this method
involves incorporating one or more cannula, which may be inserted
over the video dilator, and seated on the disc space using the same
path achieved by insertion of the video dilator. Additional cannula
may then be placed over this initial cannula, until the desired
access has been achieved. Once the cannula are in position over the
slender dilator, the surgeon may remove the dilator and use direct
vision through the cannula, or use the slender dilator to continue
to view the disc space, or both.
[0082] According to varying embodiments, this dilator and cannula
system allows simultaneous illumination and video imaging of the
path through which the surgeon must navigate to reach the surgical
site. This in turn reduces the risk of unwanted dissection,
unwanted exposure and damage to surrounding nerves, soft or
sensitive tissue, etc. In use, the dilator may be further
manipulated in conjunction with the Sherrill retractor (see FIG.
1), wherein this Sherrill retractor provides a narrow yet deep
retracting blade, which may or may not incorporate a illuminated
end, such as by an LED, which allows the surgeon to initially probe
using the blade and remove the initial tissue immediately below the
incision. The Sherrill retractor blade therefore provides an
initial depth of illumination and navigation, and clears a passage
for further insertion of the dilator. Multiple views of the
Sherrill retractor used in combination with the dilator are shown
in the appended drawing FIGS. 1-4.
[0083] This approach and apparatus is further advantageous in that
it alleviates a common problem experienced by surgeons performing
minimally invasive surgical procedures, which is fatigue. Using
this dilator apparatus and method the surgeon is not required to
position himself or herself over the cannula, or over a cumbersome
or bulky microscope, which are frequently required in other
surgical methods. By avoiding the positioning of the surgeon over
the patient's body, the cannula, the microscope, etc., the surgeon
is able to avoid significant discomfort and fatigue, which occurs
naturally over time, particularly due to the surgery exceeding two
hours to complete, or in some cases, 8 to 10 hours to complete.
Using this method, the surgeon further avoids the necessary
precautions required for exposure to radiographic imaging using
this method. For example, the surgeon, by eliminating the use of
x-rays and other radiographic equipment, is not required to wear a
lead vest, a neck shield, a leaded glass face shield, etc. This
further reduces the weight that the surgeon must bear during the
operation, further reducing the stress and fatigue on the surgeon
during the procedure.
[0084] Although not shown in the enclosed drawing figures, the
slender dilator may further comprise one more mechanisms for
cleaning or clearing the lens of the CMOS video camera at the
distal end of the dilator. According to one embodiment, the
clearing of the lens may occur mechanically, such as by a wiping
mechanism, applied to a dilator such as the one shown in FIGS. 5-6
and 19. This wiping mechanism may be mechanically operated from the
opposite distal end of the slender dilator as the one incorporating
the CCD or CMOS video device, such as by a trigger mechanism. In
operation, by moving the trigger longitudinally along the axis of
the dilator, the surgeon can move the wiping device across the lens
of the CCD or CMOS video device, thereby clearing the lens of loose
tissue, mucus, or other fluids.
[0085] According to one particular embodiment of the present
disclosure, the invention involves the use of one or more cannula
of variable lengths, which according to a preferred embodiment are
applied over one or more dilators. These cannulas can have a
variety of shapes depending upon the surgical requirement. Ovoid,
egg-shaped or round have been described, and an angled working edge
is further contemplated. The apparatus of this system are unique in
that they have incorporated a source of illumination built into the
walls of the cannula, which carry the light to the base of the
portal of the cannula, and further incorporate camera/video
capabilities.
[0086] Attention is drawn to FIGS. 7-18. One or more cannula in a
preferred embodiment are disclosed, and are generally tubular in
form, with a support wall which has an open distal end and an open
proximal end. The distal end may be rounded so that tissues are
pushed aside gently as the cannula is inserted through the patient.
A bore runs the length of the cannula from the open distal end to
the open proximal end, and provides access to the targeted spinal
area for instrument insertion, and insertion and removal of implant
devices, arthroscopic devices, graft materials, bone cement, and
other materials and devices.
[0087] A cross-sectional shape of the support wall of the bore may
be round, oval, elliptical, crescent-shaped, a half-sphere or
half-oval or another suitable shape. The cross-sectional shape has
a width, which may have a measurement in the range of about 10-50
millimeters. Preferably the width is in the range of about 15-35
millimeters. The open proximal end may further comprise a plurality
of grip features which allow the surgeon to grip the cannula. The
cannula may be formed of substantially sterile material, and may
further comprise biocompatible polymers, elastomers, ceramics, or
aluminum or other metals. According to one embodiment, the cannula
is disposable. In another embodiment, the cannula is reusable.
[0088] One aspect of the present disclosure is providing a cannula
with an incorporated illumination source that provides enhanced
illumination to the surgical site sufficient to incorporate
camera/video capabilities with the apparatus and system. According
to one particular embodiment, the illumination is provided by
incorporating one or more fiber optic strands in the tubular body
of the cannula. The fiber optics can run circumferentially or along
opposite walls of the cannula and preferably terminate at least a
centimeter from the bottom of the device. The light fibers may be
fashioned in an annulus around a camera device (See FIG. 17) to
provide illumination to the surgical site where images are being
captured by the camera chip device. In still another embodiment,
the light fibers may be replaced by one or more LEDs (See FIGS.
14-16) in a remote light source or at the distal-tip of the camera
chip device. The light source may come from an external device such
as a headlight lamp, or a standard-type light source commonly found
in operating rooms which plugs into an adaptor on the disposable
cannula.
[0089] Referring now in detail to FIGS. 7-13, various cannula
according to one embodiment of the system of the present disclosure
are shown. In FIG. 7, a perspective view of a cannula 2 is shown
having a generally circular first surface 4 and a generally
elliptical second surface 6. About one intersection of the first
surface 4 and second surface 6 is a channel or lumen 8 for
inserting one or more fastening devices, such as a screw, for
securing the cannula 2 to the surgical site. The cannula 2 shown in
FIG. 7 may vary in lengths and widths according to the anatomy of
the patient, the surgical site to be accessed, and other factors
relating to the surgery, including the tools or implants that are
required to be inserted into the cannula 2.
[0090] Referring now to FIG. 8, the cannula 2 shown in FIG. 7 may
be coupled to one or more additional cannula 12, for example, by
way of a compression fit between the two or more cannula 2, 12. As
shown in FIG. 8, the second cannula 12 may be inserted by a
compression relief 14 formed about one distal end of the second
cannula 12 that is dimensioned to fit in compression with the
tubular body 10 of the first cannula 2. According to alternate
embodiments, an interlocking fit may be further accomplished by way
of a snap fitting, a tongue and groove fitting, or other means of
securing the first cannula 2 to the second cannula 12 that are
known in the art. In an alternative embodiment, the cannula (2, 12)
may be interlocked in a predetermined configuration that permits
the cannula (2, 12) to expand in telescoping fashion.
[0091] Referring now to FIG. 9, the first and second cannula 2, 12
are shown in a cross-sectional view. This assembly includes at
least one channel or lumen 8 for inserting at least one fastening
device, such as a screw, as well as two smaller lumens or channels
14, 16 which may be used for inserting one or more fiber optic
strands/bundles for providing enhanced illumination. These channels
14, 16 may run substantially the entire length of the second
cannula 12, and may be greater or fewer in number than shown in
FIG. 9. The objective of providing these channels 14, 16 on the
interior of the cannula assembly is to provide sufficient lighting
to allow the surgeon to view the surgical site and complete the
surgery without visual impairment.
[0092] Referring now in detail to FIG. 10, the first and second
cannula 2, 12 are shown in a docked or assembled state. The second
cannula 12 may vary in length to accommodate surgery taking place
in various portions of the patient's body, and according to
alternate embodiments may be asymmetrical about its length, thereby
providing a larger opening at one end than the distal end which
mates with the first cannula 2. Thus, in operation, the first
cannula 2 is secured by way of a fastening member such as a screw,
and then the second cannula 12 is inserted into the first cannula
2. According to a preferred embodiment, one or more of the cannula
2, 12 shown in FIG. 10 may be disposable. According to alternate
embodiments, the cannula 2, 12 shown in FIG. 10 may be
reusable.
[0093] FIG. 11 shows a perspective view of a cannula 22 with at
least one slot 24 for accommodating compression or expansion of the
tubular body of the cannula 22. Similar to the second cannula 12
discussed above, this cannula may be inserted into the base cannula
2 which is secured to the surgical site. This cannula 22 also
includes channels 26, 28 for inserting one or more fiberoptic
bundles for providing illumination.
[0094] Referring now to FIG. 12, the cannula 22 of FIG. 11 is shown
with the cannula 2 of FIG. 7, and is oriented in a manner to permit
interlocking between the first cannula 2 and this slotted cannula
22. FIG. 13 shows the cannula 22 of FIG. 11 and the cannula 2 of
FIG. 7 in a docked or assembled position. This docking occurs
similar to that described in relation to FIG. 8 above, such that
there is a compression fit between the two cannula 2, 22, although
in FIG. 13 cannula 22 is depicted fitting over cannula 2. In
certain embodiments, the placement of the slotted cannula 22 on the
base cannula 2 does not interfere with the surgeon's ability to
remove or replace the fastening member. This assembly therefore
provides an extended cannula which includes channels 26, 28 for
inserting one ore more fiberoptic bundles to provide adequate
lighting. These channels 26, 28 may also provide a location for
securing an insert which may provide video capabilities within the
tubular body of the cannula assembly, either hardwired or
wirelessly. In another embodiment, multiple slotted cannula,
similar to cannula 22, may be joined such that the slot(s) in a
first slotted cannula aligns with the slot(s) in a second slotted
cannula.
[0095] Referring now in detail to FIG. 16, a camera insert 40 which
may be inserted into a slot of the cannula 22. Accordingly, the
base cannula 2 which has been secured to the operating site is then
coupled to the slotted cannula 22. Once the slotted cannula 22 is
in place, a tool 45 may be used to insert the camera insert 40 into
the cannula 22 as shown in FIG. 16. Subsequently, the tool 45 may
be removed, or alternatively the tool 45 may incorporate electrical
leads to the insert and remain in the slot of the cannula 22 during
the surgery. Additional illumination, including by one or more
fiber optic strands/bundles (not shown in FIG. 16) may also be
provided to accommodate lighting insert. According to one
embodiment, the camera insert 40 provides both video capabilities
and illumination to the surgical site. Further description of the
various camera technologies which may be incorporated in this
design shown in FIG. 16 are described in detail herein, but
expressly include CCD and CMOS technology.
[0096] According to an alternative embodiment, one or more light
fibers/bundles may be fashioned in an annulus around the camera
insert 40 to provide illumination to the surgical site. In still
another embodiment, the light fibers may be replaced by LEDs in a
remote light source or at the distal-tip of the cannula 12 or the
camera insert 40. The light source may come from an external device
such as a headlight lamp, or a standard-type light source commonly
found in operating rooms which plugs into an adaptor on the cannula
12.
[0097] According to a preferred embodiment, the cannula described
herein comprise at least one slot through which one or more camera
device(s) can be inserted on a complimentary thin plastic composite
stem-shaped insert, which preferably fits in a tongue and groove
fashion along the tubular body of the cannula. The camera device(s)
with associated wide-angle optics and its composite holder can be
removed during the course of the operation for cleaning or when the
cannula needs to be re-directed during the course of the surgery.
The camera device, which according to a preferred embodiment is
based on either CCD or CMOS technology, may have the necessary
video-processing circuitry onboard the camera chip housing or the
video-processing circuitry may be housed several meters away from
the camera chip and connected by a cable or via wireless
transmission.
[0098] Referring again the drawing figures, FIG. 14 shows two views
of a cannula which incorporates light emitting diode or "LED"
illumination devices and at least one slot for incorporating a CMOS
or CCD camera insert into the cannula wall. As shown in FIG. 14,
the cannula is generally ovoid in shape (as viewed in cross-section
or in a top plan view), and has at least one inwardly facing
shoulder, through which one or more LED's may be inserted or
secured for providing illumination about the interior of the
cannula. According to a preferred embodiment, the cannula further
comprises at least one planar wall, which breaks the generally
ovoid shape of the cannula, and it is about this planar surface
that the CMOS or CCD camera insert is preferably secured.
[0099] According to a preferred embodiment, the CMOS or CCD camera
insert is inserted into a slot or groove or channel which is formed
about one interior wall of the planar surface of cannula as shown
in FIG. 14. Alternatively, the CMOS or CCD camera insert can be
attached by other means, such as by using fastening devices known
in the art, or by attaching magnetically, for example, by way of
one or more neodymium magnets.
[0100] According to the embodiment shown in FIG. 14, the inwardly
facing shoulder creates an interior plane (as viewed in
cross-section) which accommodates the coupling of a progressive
cannula, thereby extending the overall length of the cannula. Thus,
one or more of the progressive cannula, which may be coupled
together in a telescoping arrangement, may be disposable, reusable,
etc.
[0101] FIG. 15 shows a more detailed view of the location of the
LED devices, which according to a preferred embodiment are at least
three in number. The LED devices are preferably spaced equidistance
from one another and at opposite poles of the generally ovoid
cross-sectional shape of the cannula. According to alternate
embodiments, fewer or greater number of LEDs may be provided for
providing sufficient illumination within the cannula, and it is
expressly understood that locations other than those shown in FIGS.
14-15 are understood to be compatible with the nature of the
invention disclosed herein.
[0102] Referring again to FIG. 16, a CMOS or CCD camera insert,
which may be hardwired to a connector, is shown in a perspective
view in relation to a progressive cannula according to one
embodiment. As shown in FIG. 16, the CMOS or CCD camera insert may
be inserted along the interior portion of the generally planar
surface of cannula, to a certain depth of the cannula, such that it
is positioned to capture images at the distal end of cannula (i.e.,
the end of the cannula closest to the surgical site).
[0103] As shown in FIG. 16, the distal end of the cannula may also
comprise a exterior slot for securing to an anchor or guide wire,
which may be affixed to one or more anatomical features located at
or adjacent the surgical site. Alternatively, this slot may also
facilitate connection of this cannula to one or more progressive
cannula, and according to one embodiment may serve as a guide for
one or more surgical syringes, such as the type typically used for
bone marrow extraction.
[0104] The connector shown in FIG. 16 may be hardwired to the CMOS
or CCD camera device, and is of a nature to connect to one or more
display means, such as an LCD or LED or other video display. Thus,
images captured by the CMOS or CCD camera device are transmitted
via the connector to the display for viewing either still or live
video images captured during the surgery.
[0105] Referring now to FIG. 17, a detailed perspective view of the
CMOS or CCD camera device 31 and fiber optic array of illumination
members are shown. According to this embodiment, the CMOS or CCD
camera device 31 is protected by a housing, which is generally
cylindrical and surrounds a portion of the CMOS or CCD camera
device 31. At one end of the camera housing is an opening for the
lens of the CMOS or CCD camera device 31, and also for the fiber
optic array of illumination members. In this embodiment, the fiber
optic array of illumination members substantially surrounds the
lens of the CMOS or CCD camera device 31. These illumination
members according to a preferred embodiment are fiber optic
strands, which are arranged in one or more layers about the
circumference of the lens of the CMOS or CCD camera device 31. The
overall size of the CMOS or CCD camera device 31, fiber optic array
of illumination members and camera housing are sufficiently small
such that they do not interfere with the insertion of tools,
implants, etc. in the body of the cannula and used by the surgeon
during the surgical procedure. Other details regarding the CMOS or
CCD camera insert are provided above in connection with FIGS.
7-13.
[0106] Additional views of the CMOS or CCD camera insert and the
cannula according to a preferred embodiment are shown in FIG. 18.
As shown in FIG. 18, the CMOS or CCD camera insert is attached to
an insert which operates like a stem and slides longitudinally down
one planar surface of the cannula where it engages a slot. This
engagement between the insert and the slot secures the CMOS or CCD
camera device to the interior of the cannula. The connector shown
in FIG. 18 provides both power and the illumination necessary to
operate the CMOS or CCD camera device, including the fiber optic
array of illumination members.
[0107] Referring now to FIG. 19, a dilator assembly according to
one alternate embodiment is shown. During a surgical procedure, it
may be necessary for a initial probe, such as a slender dilator
(also known as a pilot cannula) to be inserted into a small
incision and used to probe the tissue between the incision and the
surgical site. The pilot dilator may be used for this purpose, and
may incorporate the video and/or illumination capabilities as
described in more detail above. According to this alternative
embodiment, the pilot dilator is approximately 2.5 millimeters to
10 millimeters in diameter.
[0108] Additional dilators/cannula may be inserted beside or over
the first dilator in a progressive fashion until a sufficient
pathway through the patient's tissue and anatomy has been formed
for inserting one or more of the progressive cannula described
above over these progressive dilators. By way of example but not
limitation, a second dilator ranging in diameter from 7.5
millimeters to 12.5 millimeters may be placed over and around the
first dilator, then a third dilator ranging in diameter from 10
millimeters to 15 millimeters may be placed over the second
dilator, and a fourth dilator ranging in diameter from 12.5
millimeters may be placed over the third dilator. This step may be
repeated several times by the surgeon, as necessary, until an
adequate sized pathway is formed for inserting the cannula over the
dilator assembly without causing trauma to the incision, the
patient's anatomy, the surgical site, etc. It is expressly
understood, although not depicted in FIG. 19, the video
capabilities and illumination capabilities described herein may be
incorporated with the pilot cannula and each of the first, second,
third and fourth dilators described above (and any additional
progressive dilators) for facilitating insertion, placement, and
for achieving the other benefits described in the present
disclosure.
[0109] Various figures (shown or incorporated by reference herein),
e.g. FIGS. 20 A-E, show the cannula 64 having an elliptical
cross-section. In one embodiment, the ellipse has a width of about
20 millimeters in its major axis, and a width of about 16
millimeters in its minor axis. It will be appreciated that the
cannula cross-section may be of a different size and have a
different shape including, for example, an oval, a rectangle, a
square, a rhombus, a trapezoid, a parallelogram, a polygon and a
generally oblong shape such as an egg or football shape. As will be
appreciated by one having skill in the art, the cross-sectional
shape of the cannula 60 permits the user to employ instruments in
the cannula that require movement or manipulation in one direction,
preferably along the major axis, but to a lesser extent in the
other direction. The oblong shape of the cannula 60 would permit,
for example, rasps and curettes to be manipulated and used in a
joint in a minimally invasive fashion. Similarly, the tool 32 can
be manipulated and used in a joint even with the head 36 at any
angle relative to the shaft. One having skill in the art will
appreciate that the dimensional requirements of the cannula 60 will
vary based on the length of the cannula, and the items or tools
being inserted therein.
[0110] FIG. 20D shows two vertebrae 20 and a view of the footprint
made by a cannula 60 in one embodiment of the present disclosure.
As will be appreciated, the cannula 60 provides access to adjacent
facets of two adjacent vertebrae. The oval or elliptical shape of
the cannula 60, however, allows the procedure to be performed in a
minimally invasive fashion by reducing the incision required to
gain access to the surgical site and the reducing the tissue
exposed during the procedure. FIG. 20E is a side aspect view of the
cannula 60 placed over two adjacent vertebrae 20 separated by a
joint space. The view in FIG. 20E is the side aspect view of the
cannula 60 in, for example, FIG. 20D. FIG. 20E exemplifies another
advantage provided by certain embodiments of the cannula 60 in the
present disclosure in that it provides optimal access to a surgical
site that may have anatomy or bone features that make it desirable
to have, for example, an angled and/or curved end to the cannula.
One having skill in the art will further appreciate that an ideally
shaped cannula 60 will allow the user to more safely and reliably
access the surgical site and will reduce the risk of injury to the
surrounding tissue.
[0111] FIG. 20F shows the shaft and cross-sectional or end views of
various dilators 66. The various dilators 66 shown are of various
sizes, having various lengths and cross-sectional areas. As can be
seen by the cross-sectional or end view of the dilators 66, the
dilators 66, like the cannulae described above have an oval or
elliptical shape. According to a preferred embodiment, one or more
dilators may be used to dilate the muscle or other tissue of the
patient to access the surgical site. A first slender dilator 66 is
used to probe through the muscle or other tissue and to locate the
desired vertebrae. Once that first slender dilator 66 is seated,
additional dilators 66 may be inserted around the previously seated
dilator 66 until the desired circumference through the muscle or
other tissue is achieved. In this fashion, the first slender
dilator 66 serves as a radiographic marker, and establishes the
path for subsequent dilators 66 of greater circumference than the
first slender dilator 66. This serves to reduce ischemic injury to
the patient and reduces the time necessary to locate and access the
desired vertebrae. The first slender dilator 66 has a sufficient
circumference to be easily viewed by x-ray or other imaging
technology when seating the dilator 66 on the desired vertebrae.
The dilators 66 are variable in length, preferably ranging from
3-14 cm.
[0112] Once the dilators 66 have been used to dilate the muscle
tissue surrounding the path to the desired vertebrae, a cannula 60
may be inserted into the interior circumference of the dilators 66.
The cannula 60 according to a preferred embodiment is ovoid in
shape to permit dissection from caudad to cephalad (as opposed to
from medial to lateral) and further accommodate dissection about
the facet joint. As with the dilators 66, the cannula 60 may be
variable in length, ranging preferably from 3-10 cm, to accommodate
varying depths from skin to bone. As mentioned above, the
cross-sectional geometry of the cannula is preferably ovoid in
shape, and in a preferred embodiment the major diametrical axis of
the cannula is about 20 mm, and the minor diametrical axis of the
cannula is about 16 mm.
[0113] Varying embodiments of the cannula described herein may
further comprise an angled or sloped surface at one distal end of
the cannula for accommodating access and viewing of an implant site
that is not directly below the incision. By way of example but not
limitation, a surgeon may use one or more of the angled cannula
shown in FIGS. 20A-20F in conjunction with the dilators 66
described herein to probe through the muscle or other tissue using
an angled approach, thereby allowing access to a specific vertebrae
either above or below the vertebrae directly below the incision.
Once the dilators have been used to clear a path through the muscle
or other tissue at an angled approach, the angled cannula may be
inserted with the angled or sloped surface oriented so that the
angled or sloped surface rests near horizontally against the
vertebrae, as shown in the appended Figures. This angled cannula
assists the access and visibility of additional vertebrae without
requiring additional incisions, and further permits securing
fastening devices such as screws using an angled approach. As with
the other cannula described above, the cross-sectional shape of the
angled cannula is preferably ovoid in shape, and the entire
longitudinal length of the angled cannula may be slightly greater
than the other cannula described herein.
[0114] According to one particular embodiment of the present
disclosure, a system is provided where the cannula/dilator tools
further include one or more electrical probes 51 at the exit
portal, which are adapted to assist the surgeon in identifying the
presence and location of nerves as the probe is advanced during
minimally-invasive surgery, thereby providing a device for guiding
the path of other surgical instruments to be inserted into the
intervertebral space. For example, an expandable tip cannula 50 may
be provided, which functions both as an access portal for spinal
surgery and as a system for nerve surveillance, such that the
presence and relative position of the nerves of the lumbo-sacral
plexus can be detected as the expandable tip cannula 50 is inserted
through the patient's fascia and musculature. One particular
advantage of determining the position of the nerves with respect to
the distal tip of the cannula is that the nerves can be avoided or
gently moved out of the surgeon's way while inserting the cannula.
This concept may also be incorporated in the one or more slender
dilator tools described in detail herein.
[0115] According to another embodiment, the present disclosure
provides a system of cannulas/dilators adapted to assist the
surgeon in guiding the path of surgical instruments received into
the intervertebral space, while identifying the presence and
location of para-spinal nerves as the cannula/dilator is advanced
to a patient's intervertebral space during minimally invasive
surgery. In various aspects of the present disclosure, the probes
may be comprised of one or more electrodes powered at a low level
to sense the position of the nerves of the lumbo-sacral plexus
through continuous real time electromyographic monitoring.
Alternatively, these electrodes can be powered at a higher level
such that they operate to cauterize blood vessels. Safety systems
ensure that power levels sufficient to cause cauterization are not
activated if a nerve is sensed to be near the electrodes at the
distal end of the cannula/dilator.
[0116] The system according to one embodiment of the present
disclosure includes providing illumination and video capability
with a cannula having a shape other than round (e.g., oval,
pointed, square cornered, etc.) and having an end (e.g., the end
inserted into the patient, distal from the user) that is angled
and/or shaped to be ideally seated in a surgical site. Asymmetrical
cannulas may allow visualization of the facet joint, and an
"egg-shaped" cross section may allow for the best view of the facet
joint and minimizes the medial-lateral dissection that a round
cannula would require.
[0117] Still other aspects of the invention are directed to cannula
instruments that have a patient contacting end that is adjustable
to assume a predetermined conformation. Thus, in one embodiment,
material forms the tip end that comes into contact with bone,
tissue, and especially as it nears nerve tissue, with such cannula
end material being malleable to an extent necessary for the surgeon
to mold the end conformation such that it achieves desired
avoidance of particular structures encountered in any particular
surgery. Thus, if a bony outcropping, a nerve fiber, etc. is
perceived by the surgeon, the cannula tip end can be adjusted to
avoid undesired contact or interference with such tissues or
structures. In particular embodiments, the ability to adjust the
geometric parameters of the tip end is achieved by manipulation of
the other end of the instrument. For example, providing a turnable
component at the opposite end of the instrument, the shape of the
other end of the instrument (i.e. the end inserted into the
patient) can be adjusted to expand circumference, reduce
circumference, render the opening more or less oblong, etc. In such
a manner, it is possible to avoid having to remove the instrument
or cannula from the patient's site to adjust the morphology of the
instrument or cannula operating end, thus saving time, avoiding
undesired reinsertion procedures, etc.
[0118] Certain embodiments of the surgical cannula, which may be
used in conjunction with certain aspects of the present disclosure,
include cannula having a bottom opening that is angled oblique to
the top opening. These cannuale may be in correspondingly larger or
smaller form factors so that they may become nested within one
another for facilitating insertion in the patient. The cannula may
have an elliptical cross-section. In one embodiment, the ellipse
has a width of about 20 millimeters in its major axis, and a width
of about 16 millimeters in its minor axis. It will be appreciated
that the cannula cross-section may be of a different size and have
a different shape including, for example, an oval, a rectangle, a
square, a rhombus, a trapezoid, a parallelogram, a polygon and a
generally oblong shape such as an egg or football shape. As will be
appreciated by one having skill in the art, the cross-sectional
shape of the cannula permits the user to employ instruments in the
cannula that require movement or manipulation in one direction,
preferably along the major axis, but to a lesser extent in the
other direction. The oblong shape of the cannula would permit, for
example, rasps and curettes to be manipulated and used in a joint
in a minimally invasive fashion. Similarly, other tools can be
manipulated and used in a joint at any angle relative to the shaft
of the tool. One having skill in the art will appreciate that the
specific dimensional requirements of the cannula will vary based on
the length of the cannula, and the items or tools being inserted
therein.
[0119] As will be appreciated, the cannula provides access to
adjacent facets of two adjacent vertebrae. The oval or elliptical
shape of the cannula, however, allows the procedure to be performed
in a minimally invasive fashion by reducing the incision required
to gain access to the surgical site and the reducing the tissue
exposed during the procedure. Another advantage provided by certain
embodiments of the cannula of the present disclosure is that it
provides optimal access to a surgical site that may have anatomy or
bone features that make it desirable to have, for example, an
angled and/or curved end to the cannula. One having skill in the
art will further appreciate that an ideally shaped cannula will
allow the user to more safely and reliably access the surgical site
and will reduce the risk of injury to the surrounding tissue.
[0120] Various dilators may be used (in connection with the cannula
of the system described above) having various sizes, various
lengths and cross-sectional areas. The dilators, like the cannula
described above, may have an oval or elliptical shape. According to
a preferred embodiment, one or more dilators may be used to dilate
the muscle or other tissue of the patient to access the surgical
site. According to a preferred embodiment, a first slender dilator
is used to probe through the muscle or other tissue and to locate
the desired vertebrae. Once that first slender dilator is seated,
additional dilators may be inserted around the previously seated
dilator until the desired circumference through the muscle or other
tissue is achieved. In this fashion, the first slender dilator
serves as a radiographic marker, and establishes the path for
subsequent dilators of greater circumference than the first slender
dilator. This serves to reduce ischemic injury to the patient and
reduces the time necessary to locate and access the desired
vertebrae. The first slender dilator has a sufficient circumference
to be easily viewed by x-ray or other imaging technology when
seating the dilator on the desired vertebrae. The dilators are
variable in length, preferably ranging from 3-14 cm.
[0121] Once the dilators have been used to dilate the muscle tissue
surrounding the path to the desired vertebrae, a cannula may be
inserted into the interior circumference of the dilators. The
cannula according to a preferred embodiment is ovoid in shape to
permit dissection from caudad to cephalad (as opposed to from
medial to lateral) and further accommodate dissection about the
facet joint. As with the dilators, the cannula may be variable in
length, ranging preferably from 3-10 cm, to accommodate varying
depths from skin to bone. As mentioned above, the cross-sectional
geometry of the cannula is preferably ovoid in shape, and in a
preferred embodiment the major diametrical axis of the cannula is
about 20 mm, and the minor diametrical axis of the cannula is about
16 mm.
[0122] Varying embodiments of the cannula described herein may
further comprise an angled or sloped surface at one distal end of
the cannula for accommodating access and viewing of an implant site
that is not directly below the incision. By way of example but not
limitation, a surgeon may use one or more of the cannula described
herein in conjunction with the dilators described herein to probe
through the muscle or other tissue using an angled approach,
thereby allowing access to a specific vertebrae either above or
below the vertebrae directly below the incision. Once the dilators
have been used to clear a path through the muscle or other tissue
at an angled approach, the angled cannula may be inserted with the
angled or sloped surface oriented so that the angled or sloped
surface rests near horizontally against the vertebrae. These
cannula assist the access and visibility of additional vertebrae
without requiring additional incisions, and further permits
securing fastening devices such as screws using an angled
approach.
[0123] As with the other cannula described above, the
cross-sectional shape of the angled cannula is preferably ovoid in
shape, and the entire longitudinal length of the angled cannula may
be slightly greater than the other cannula described herein.
According to another embodiment of the present disclosure, a system
is provided where the cannula further include one or more
electrical probes at the exit portal, which are adapted to assist
the surgeon in identifying the presence and location of nerves as
the probe is advanced during minimally-invasive surgery, thereby
providing a device for guiding the path of other surgical
instruments to be inserted into the intervertebral space.
[0124] An expandable tip cannula may be provided, which functions
both as an access portal for spinal surgery and as a system for
nerve surveillance, such that the presence and relative position of
para-spinal nerves can be detected as the expandable tip cannula is
inserted through the patient's facia and musculature. An advantage
of determining the position of the para-spinal nerve with respect
to the distal tip of the cannula in particular is that the
para-spinal nerve can be avoided or gently moved out of the
surgeon's way while inserting the cannula.
[0125] Accordingly, the present disclosure provides a system of
cannulas adapted to assist the surgeon in guiding the path of
surgical instruments received into the intervertebral space, while
identifying the presence and location of para-spinal nerves as the
cannula is advanced to a patient's intervertebral space during
minimally invasive surgery. In various aspects of the present
disclosure, the probes may be comprised of one or more electrodes
powered at a low level to sense the position of a para-spinal nerve
through continuous real time electromyographic monitoring.
Alternatively, these electrodes can be powered at a higher level
such that they operate to cauterize blood vessels. Safety systems
ensure that power levels sufficient to cause cauterization are not
activated if a nerve is sensed to be near the electrodes at the
distal end of the cannula.
[0126] The present disclosure is also directed to an angled tool
for use in performing spinal surgery procedures that includes
illumination and/or video capabilities. According to a preferred
embodiment, the angled tool is comprised of a longitudinal shaft,
and has a first or operating end and a second or working end. The
shaft is preferably tubular and has a bore running through the
length of the angular tool suitable for receiving an insert. The
insert further comprises CMOS or CCD video imaging device(s), which
permit a user to view images captured by the at least one CMOS or
CCD imaging device. According to one embodiment the insert and
CMOS/CCD video imaging device(s) are disposable. In another
embodiment they are reusable. In yet another embodiment, the angled
tool further comprises one or more illumination devices arranged in
an annulus around the one or more CMOS or CCD video imaging devices
to enhance illumination at the surgical site.
[0127] In use, by providing one or more CMOS or CCD video imaging
devices (which according to one embodiment further comprise at
least one wireless transmitter for transmitting data wirelessly to
at least one display) and illumination surrounding the video
imaging devices, the surgeon has the ability to view and illuminate
the patient operating site and/or the interior of the surgical
cannula with the angled tool, in addition to any illumination that
is provided by the cannula.
[0128] According to yet another embodiment of the present
disclosure, a tool (other than the angled tool described above) is
provided that comprises at least one CMOS or CCD video imaging
device, which permits a user to view images captured by the CMOS or
CCD imaging device of the disc space or other surgical area to be
operated on. For example, one or more specula, curettes, awls,
blades, scrapers, or other surgical tools may incorporate the video
insert described in greater detail below, for capturing and viewing
images of the surgical site after dissection has occurred. This may
be accomplished by providing a CMOS or CCD camera at the distal end
of the one or more tools, and either wirelessly or hardwire
transmitting the images captured by that CMOS or CCD camera to a
display.
[0129] According to another embodiment of the present disclosure, a
tool is provided that comprises at least one CMOS or CCD video
imaging device, which permits a user to view images captured by the
CMOS or CCD imaging device of the disc space or other surgical area
to be operated on. For example, one or more disc debridement tools
may incorporate the video insert described in greater detail below,
for capturing and viewing images of the intervertebral disc space
after and during dissection. This capacity allows for a more
complete and safe disc space preparation. A more precise carpentry
of the disc space allows for an increased potential for fusion and
a reduction of vertebral endplate or soft tissue injury. This may
be accomplished by providing a CMOS or CCD camera at the distal end
of the one or debridement tools, and either wirelessly or hardwire
transmitting the images captured by that CMOS or CCD camera to a
display.
[0130] Accordingly, the methods disclosed herein provide a surgeon
viewing the operative site, instead of through the oculars of the
microscope, but rather with the ability to view the patient's
anatomy by presenting the images of the surgical site on a video
screen or other display in front of him (or her) and in front of
any assistant(s), consulting surgeons, hospital staff, etc. Due to
the camera chip device and associated optics being placed directly
at or immediately adjacent the operative site, the image collected
is free from the distortions and the "field-flattening" effect
commonly associated with complex optical stacks commonly used in
operating microscopes and endoscopes. These novel apparatus and
surgical methods result in a significant increase in "depth-cues"
and color-reproduction. The camera device technology (preferably
CCD or CMOS) provides a three dimensional-type picture to the
surgeon with all necessary illumination and without the extra costs
of adding a second camera and expensive intra-ocular optical
orientations. The costs of the microscope and its maintenance,
plastic draping, sterility/contamination issues and surgeon fatigue
are either eliminated or substantially reduced.
[0131] A variety of other apparatus and methods may be employed in
conjunction with the various aspects described herein to achieve
fusion without departing from the spirit of the invention, such as
the following apparatus and methods hereby incorporated by
reference in their entireties: U.S. Patent Publication Nos.
2010/0137690 to Miles, et al.; 2009/0299411 to Laskowitz, et al.;
2009/0299412 to Marino; 2009/0299477 to Clayton, et al.;
2009/0275995 to Truckai, et al.; 2009/0287262 to Bertagnoli; and
U.S. Pat. No. 7,621,955 to Goble, et al. Accordingly, additional
apparatus, such as a retractor or distractor may incorporate the
use of fiberoptic bundles and/or camera inserts described in
relation to FIGS. 6-8 above. In particular, according to one
embodiment of the present disclosure, a retractor device may
incorporate one or more camera inserts along the shaft of the
retractor similar to the camera insert described in relation to
FIG. 16 above. Also, one or more fiberoptic bundles may be
integrated with the insert, or alternatively run along independent
lumens or channels along the arms of the retractor or distractor
device.
[0132] FIG. 21 depicts cross-sectional views of various cannulas
10, 12, 15, 17, 18 and is further illustrative of how these aspects
of the present invention interoperate. Although FIG. 21 depicts a
single pilot cannula 10 and four dilator cannulas 12, 15, 17, 18,
one of ordinary skill in the art will recognize that the present
invention is not limited to any specific number or shape of
cannula. It will further be recognized that cannulas of different
cross-sections would also serve the spirit of the present
invention, so long as that when cannulas of increasing size are
inserted, these larger cannulas do not expand the surgical area
uniformly in all radial directions. For example, cannulas of
triangular, elliptical, ovoid, egg-shaped or other similar
cross-sectional shapes may also achieve objects of the present
invention. In various embodiments, features of the present
invention comprise conical, bullet-shaped, or tapered distal ends
so as to facilitate their insertion and expand tissue rather than
cutting or tearing and thereby reducing injury to a patient.
[0133] These cannulas, which may be inserted in progressively
larger sizes (as will be described later), are constructed or
formed in this manner so as to avoid or mitigate complications
presented with the prior art (as described above). Specifically,
the insertion of these cannulas with asymmetric cross-sections
allows a user to expand the surgical area without expanding into a
specific region(s) where the device may impinge upon nerves and
other tissue.
[0134] Additionally, or in place of a guide pin, a pilot cannula of
slightly larger diameter may be inserted. This pilot cannula may
either be placed around or proximal to the guide pin. The pilot
cannula may further include means, such as conductive wires and
sensors, to detect the proximity of nerves and nerve structures.
Guide pins and/or pilot cannula(s) may further be used to direct
the location of various dilators which may gradually expand the
desired surgical area in a non-concentric or radially non-uniform
fashion so as to allow adequate room for surgical tools and
procedures, with reduced risk of impinging upon nerves.
Specifically, dilators of the present invention are shaped in an
asymmetric fashion so as to expand the surgical area in a defined
radial direction(s) and to avoid impingement of the areas with
higher concentrations of nerve structures.
[0135] Various devices of the present invention include anchoring
means, such as screws and/or tangs and stakes to secure the devices
once located in a desired position. These anchoring means further
operate to reduce the risk of injury to the patient as
repositioning or re-insertion of these and similar devices further
increase the risk of damaging surrounding nerves and tissue. Once a
sufficient degree of dilation of a surgical area is achieved,
smaller cannula disposed within the larger cannula may be removed
to allow for visibility and usable space within devices of larger
diameters. Devices of larger diameters, such as dilators of an
appropriate size, retractors, and working cannulas may be employed
to stabilize the surgical area. These devices, including an outer
working cannula, may be secured by previously discussed anchoring
means or by external mounting devices. Outer working cannula, as
will be apparent from the present disclosure, may include various
additional features such as fiber-optic lighting elements, imaging
equipment, luminescent materials, bioluminescent materials,
etc.
[0136] FIG. 22 is a cross-sectional illustration of a patient
wherein the non-working dilator cannulas have been removed from the
cavity. FIG. 22 further illustrates a formed surgical cavity of
sufficient size with minimal impingement upon the psoas and other
nerves. Specifically, as consecutively larger devices are inserted,
expansion is achieved in a direction away from areas III and IV as
shown in FIG. 22. Expanding the work area in this manner provides
for reduced risk of impinging upon nerves by avoiding areas of the
greatest concentration of nerves.
[0137] FIG. 23 depicts a working cannula 100 and a plurality of
extension cannulas, 116a, 116b, 116c, 116d, which may be fiber
optic cannulas. In one embodiment, the working cannula 100 and a
fiber optic cannula of the present invention comprise means for
engaging one another and/or maintaining communication between the
fiber optic cannula 116 and the working cannula 100. As further
shown in FIG. 23, a plurality of fiber optic cannulas 116a, 116b,
116c, 116d may be provided, each having a different length
(L.sub.1, L.sub.2, L.sub.3, L.sub.4). Different lengths are
provided in order to provide for a final combined structure (i.e.
100 and 116 combined) with a proximal end disposed at an
appropriate distance from a patient and skin edge. In one
embodiment, indicia 300 are provided on a working cannula 100
which, when inserted into a surgical work area to the appropriate
depth, reveal the corresponding fiber optic cannula which should be
utilized.
[0138] FIG. 24 is a cross-sectional illustration of a patient
illustrating features and operation of the present invention. FIG.
24 illustrates features of the previously discussed embodiments
with reference to a patient's spine 3 and nerve structure 24. As
one of ordinary skill in the art will recognize, the present
invention allows for expansion and enlargement of the surgical area
in a non-uniform manner. Accordingly, as shown in FIG. 24,
enlargement of a surgical cavity may be achieved without impinging
upon nerves or specific regions of a patient.
[0139] FIG. 25 is another cross-sectional illustration of a patient
illustrating features and operation of the present invention. FIG.
25 depicts multiple asymmetric cannulas in relation to a patient's
spine 3 and nerve structure 4. Once the working cannula 18 (i.e.
the cannula of largest desired diameter) is secured, remaining
dilator cannulas are removed. In this manner, the psoas and other
tissues are parsed so as to allow for access for spinal surgery and
a working aperture is provided. It will be recognized that the
working cannula need not be of any specific size or order to
achieve the previously described sequence. Various factors,
including patient size, procedure(s) to be performed, and/or tools
to be used may determine the appropriate size of the working
cannula.
[0140] For example, in one embodiment the working cannula 100
comprises a docking ridge 136 which comprises a generally annular
protrusion from either a portion or the entirety of the outer
circumference of the working cannula 100. The fiber optic cannula
116 may comprise a corresponding ridge or recession 140 at a
variety of locations along its longitudinal length, which is
adapted to receive the docking ridge 136 of the working cannula
100. In one embodiment, the outer diameter of the docking ridge of
the working cannula is greater than both the outer diameter of the
main portion of the working cannula and the inner diameter of the
fiber optic cannula.
[0141] The fiber optic cannula is capable of expanding, for
example, due to the inclusion of a compression gap 124. Thus, the
fiber optic cannula may be elastically expanded around both the
working cannula 100 and the docking ridge 136, and be slid or
translated into a position where the docking ridge mates or
corresponds with the receiving portion of the fiber optic cannula
116. In an alternative embodiment, docking between a fiber optic
cannula 116 and a working cannula 100 is accomplished through one
or more non-annular or non-rib like protrusions. For example, one
or more protuberances of various sizes and shapes may be provided
which interact and dock with corresponding features (e.g. female
receiving portions) of a fiber optic cannula 116. One of skill in
the art will recognize that receiving (or female) and corresponding
(male) docking members may be disposed either on the working
cannula 100 and/or the fiber optic cannulas 116a, 116b, 116c, 116d
and the present invention is not limited to an embodiment wherein
male or female docking portions reside on only one of the
contemplated devices. Indeed, male and female portions may reside
on either the working, fiber optic, or both cannulas.
[0142] In one embodiment, the compression gap of the fiber optic
cannula 116 relies on the elastic abilities of the fiber optic
cannula 116 to expand, accommodate a working cannula 100, and
retract to (or approximately to) an initial position. In
alternative embodiments, fiber optic cannulas 116 of the present
invention comprise a compression gap 124 and/or additional devices
useful for and capable of restricting an outer dimension of the
fiber optic cannula 116 and thereby securing or attaching the fiber
optic cannula 116 to a working cannula 100 or similar device. For
example, various known devices may be employed to restrict an outer
dimension of the fiber optic cannula, including but not limited to
various straps comprising buckles, Velcro, teeth and receiving
portions and adjustable strap fasteners.
[0143] As shown, working cannulas 100 are provided with at least
one cylindrical housing 104 disposed on an exterior portion of the
working cannula 100. As will be recognized, and as is described
herein, working cannulas are not limited to any particular
asymmetric geometry. Thus, D-shaped cross sections, U-shaped cross
sections, and a variety of other combinations and alternatives,
including crescent-shaped cross-sections, to the cross-sectional
shapes are contemplated for use with working cannulas of the
present invention.
[0144] While various embodiment of the present disclosure have been
described in detail, it is apparent that modifications and
alterations of those embodiments will occur to those skilled in the
art. However, it is to be expressly understood that such
modifications and alterations are within the scope and spirit of
the present disclosure, as set forth in the following claims.
[0145] The foregoing discussion of the disclosure has been
presented for purposes of illustration and description. The
foregoing is not intended to limit the disclosure to the form or
forms disclosed herein. In the foregoing Detailed Description for
example, various features of the disclosure are grouped together in
one or more embodiments for the purpose of streamlining the
disclosure. This method of disclosure is not to be interpreted as
reflecting an intention that the claimed disclosure requires more
features than are expressly recited in each claim. Rather, as the
following claims reflect, inventive aspects lie in less than all
features of a single foregoing disclosed embodiment. Thus, the
following claims are hereby incorporated into this Detailed
Description, with each claim standing on its own as a separate
preferred embodiment of the disclosure.
[0146] Moreover, though the present disclosure has included
description of one or more embodiments and certain variations and
modifications, other variations and modifications are within the
scope of the disclosure, e.g. the use of disposable components
comprising some or all of the apparatus described herein, as may be
within the skill and knowledge of those in the art, after
understanding the present disclosure. It is intended to obtain
rights which include alternative embodiments to the extent
permitted, including alternate, interchangeable and/or equivalent
structures, functions, ranges or steps to those claimed, whether or
not such alternate, interchangeable and/or equivalent structures,
functions, ranges or steps are disclosed herein, and without
intending to publicly dedicate any patentable subject matter.
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