U.S. patent application number 12/024642 was filed with the patent office on 2008-08-14 for spinal surgery methods using a robotic instrument system.
This patent application is currently assigned to Hansen Medical, Inc.. Invention is credited to Frederic H. Moll.
Application Number | 20080195081 12/024642 |
Document ID | / |
Family ID | 39661452 |
Filed Date | 2008-08-14 |
United States Patent
Application |
20080195081 |
Kind Code |
A1 |
Moll; Frederic H. |
August 14, 2008 |
SPINAL SURGERY METHODS USING A ROBOTIC INSTRUMENT SYSTEM
Abstract
Methods of performing various minimally invasive spinal surgical
applications with a flexible, robotically controlled catheter
instrument are disclosed. In one embodiment, a surgical method
comprises inserting a robotically controlled, flexible catheter
instrument through the sacral hiatus and into the epidural space of
the spine, and advancing the catheter instrument toward the lumbar
spine, to an area of the spine to be treated. The catheter
instrument is then used to perform a therapeutic procedure on the
spine, such as (without limitation), the delivery of a spinal
stabilization device, or performing a lumbar discectomy,
laminectomy, forminotomy, kyphoplasty, or spineoplasty.
Inventors: |
Moll; Frederic H.; (San
Francisco, CA) |
Correspondence
Address: |
VISTA IP LAW GROUP LLP
12930 Saratoga Avenue, Suite D-2
Saratoga
CA
95070
US
|
Assignee: |
Hansen Medical, Inc.
Mountain View
CA
|
Family ID: |
39661452 |
Appl. No.: |
12/024642 |
Filed: |
February 1, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60899048 |
Feb 2, 2007 |
|
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|
60900584 |
Feb 8, 2007 |
|
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Current U.S.
Class: |
604/510 ;
604/264; 604/35; 604/508 |
Current CPC
Class: |
A61B 34/71 20160201;
A61B 2034/102 20160201; A61G 7/0503 20130101; A61B 2017/00261
20130101; A61B 2034/2061 20160201; A61G 13/10 20130101; A61B 34/20
20160201; A61B 2034/2051 20160201; A61G 13/101 20130101; A61B 90/50
20160201; A61B 34/30 20160201; A61B 90/361 20160201 |
Class at
Publication: |
604/510 ;
604/508; 604/264; 604/35 |
International
Class: |
A61M 31/00 20060101
A61M031/00; A61M 5/00 20060101 A61M005/00; A61M 1/00 20060101
A61M001/00 |
Claims
1. A method for performing a medical procedure on a patient's
spine, comprising: inserting a robotically controlled, flexible
catheter instrument through the sacral hiatus and into the epidural
space of the spine; robotically maneuvering a distal end portion of
the catheter instrument toward the lumbar spine; and performing a
therapeutic procedure on the spine using said catheter
instrument.
2. The method of claim 1, wherein the therapeutic procedure is a
lumbar discectomy.
3. The method of claim 1, wherein performing the therapeutic
procedure comprises: puncturing a herniated disc using a needle
coupled to the catheter instrument; removing a part of the
herniated disc using an end effector coupled to the catheter
instrument; and draining an area of the herniated disc using a
suction port disposed on the catheter instrument.
4. The method of claim 1, wherein the therapeutic procedure
comprises a laminectomy.
5. The method of claim 1, wherein performing the therapeutic
procedure comprises removing a portion of the lamina of the spine
using an end effector coupled to the catheter instrument to relieve
pressure on the spinal cord of the spine.
6. The method of claim 5, wherein said end effector comprises a
drill bit or a router bit.
7. The method of claim 1, wherein the therapeutic procedure
comprises a forminotomy.
8. The method of claim 1, wherein performing the therapeutic
procedure comprises removing material from the bones of the
vertebrae that pass nerve bundles to the body from the spinal cord
of the spine using an end effector coupled to the catheter
instrument.
9. The method of claim 8, wherein the end effector comprises a
drill bit or a router bit.
10. The method of claim 1, wherein the therapeutic procedure
comprises the delivery of a spinal stabilization device.
11. The method of claim 1, wherein performing the therapeutic
procedure comprises: robotically maneuvering the distal end portion
of the catheter instrument to an interstitial space between two
spinous processes of the spine; inserting a deflated spinal
stabilization device carried by the catheter instrument into the
interstitial space; and inflating the spinal stabilization
device.
12. The method of claim 1, wherein performing the therapeutic
procedure comprises: robotically maneuvering the distal end portion
of the catheter instrument to an interstitial space between two
spinous processes of the spine; removing at least a part of an
intervertebral disc using an end effector coupled to the catheter
instrument; inserting a deflated spinal stabilization device
carried by the catheter instrument into the interstitial space; and
inflating the spinal stabilization device.
13. The method of claim 1, wherein the therapeutic procedure is a
kyphoplasty procedure.
14. The method of claim 1, wherein performing the therapeutic
procedure comprises: drilling a hole into a damaged vertebra of the
spine using an end effector coupled to the catheter instrument;
inserting a balloon carried by the catheter instrument through the
hole and into an interior cavity of the vertebra; inflating the
balloon to displace damaged vertebral tissue located in the
interior of the vertebra to thereby enlarge the cavity; deflating
and removing the balloon from the cavity; and introducing a filling
material into the cavity through the hole using the catheter
instrument.
15. The method of claim 1, wherein the therapeutic procedure is a
spineoplasty.
16. The method of claim 1, wherein performing a therapeutic
procedure comprises: drilling a hole into a damaged vertebra of the
spine using a first end effector coupled to the catheter
instrument; creating a cavity in the damaged vertebra using a
second end effector coupled to the catheter instrument; inserting a
porous retainer into the cavity using the catheter instrument; and
introducing bone graft material into the retainer via a working
lumen of the catheter instrument.
17. A method for performing a medical procedure on a patient's
spine, comprising: inserting two or more robotically controlled,
flexible catheter instruments through the sacral hiatus and into
the epidural space of the spine; robotically maneuvering the two or
more catheter instruments toward the lumbar spine; and performing a
therapeutic procedure on the spine using the two or more catheter
instruments.
18. The method of claim 17, wherein respective one or more end
effectors are coupled to respective distal end portions of each of
the two or more catheter instruments.
Description
RELATED APPLICATION DATA
[0001] The present application claims the benefit under 35 U.S.C.
.sctn. 119 to U.S. Provisional Patent Application Ser. Nos.
60/899,048, filed on Feb. 2, 2007, and 60/900,584, filed on Feb. 8,
2007. The foregoing applications are hereby incorporated by
reference into the present application in its entirety.
FIELD OF INVENTION
[0002] The invention relates generally to robotically controlled
systems, such as telerobotic surgical systems, and more
particularly to a using a robotic instrument system for performing
spinal surgery procedures.
BACKGROUND
[0003] Robotic interventional systems and devices are well suited
for use in performing minimally invasive medical procedures, as
opposed to conventional techniques wherein the patient's body
cavity is open to permit the surgeon's hands access to internal
organs. For example, there is a need for a highly controllable yet
minimally sized system to facilitate imaging, diagnosis, and
treatment of tissues which may lie deep within a patient, and which
may be accessed transcutaneously (through a surgical port) or via
naturally-occurring pathways such as blood vessels, other lumens,
via surgically-created wounds of minimized size, or combinations
thereof.
SUMMARY OF THE INVENTION
[0004] The present invention is directed to methods of performing
various surgical procedures using such robotic instrument systems.
The methods include various, minimally invasive spinal surgical
applications with a flexible, robotically controlled catheter
instrument. In one embodiment, the method comprises inserting a
robotically controlled, flexible catheter instrument through the
sacral hiatus and into the epidural space of the spine. A distal
end portion of the catheter instrument is advanced toward the
lumbar spine to an area of the spine to be treated. Then, the
catheter instrument is used to perform a therapeutic procedure on
the spine. Examples of spinal procedures that can be performed
using the present invention include a lumbar discectomy, a
laminectomy, a forminotomy, the delivery of a spinal stabilization
device, a kyphoplasty, a spineoplasty, or other spinal surgery.
[0005] The catheter instrument may be equipped with a tool,
illumination fiber, image capture device, laser, irrigation port,
suction port, needle, working cannula, grasper, shaving port,
blade, drill or other end-effector useful for the particular spinal
procedure being performed. In addition, two or more such catheter
instruments may be utilized in the methods of the present
invention. As used herein, the term "disposed on" or "carried by"
relative to a structure shall include without limitation, attached
to, coupled to, inserted through, integral with, the structure, and
shall not be limited to any particular mounting method or location
relative to the structure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The drawings illustrate the design and utility of
illustrated embodiments of the invention, in which similar elements
are referred to by common reference numerals.
[0007] FIG. 1A illustrates one embodiment of a robotic catheter
system;
[0008] FIG. 1B illustrates another embodiment of a robotic catheter
system;
[0009] FIGS. 2A-2D illustrate one embodiment of a method wherein a
flexible, robotically steerable catheter instrument is driven
through the sacral hiatus and into the epidural space;
[0010] FIGS. 3A-3D illustrate one embodiment of a method for a
lumbar discectomy procedure using a flexible, robotically steerable
catheter instrument;
[0011] FIGS. 4A-4D illustrate one embodiment of a method for a
lumbar laminectomy procedure using a flexible, robotically
steerable catheter instrument;
[0012] FIGS. 5A-5E illustrate one embodiment of a method for a
foraminotomy procedure using a flexible, robotically steerable
catheter instrument;
[0013] FIGS. 6A-6D illustrate one embodiment of a method for
delivering a spinal stabilization device using a flexible,
robotically steerable catheter instrument;
[0014] FIGS. 7A-7F illustrate one embodiment of a method for a
kyphoplasty procedure using a flexible, robotically steerable
catheter instrument; and
[0015] FIGS. 8A-8E illustrate one embodiment of a method for a
spineoplasty procedure using a flexible, robotically steerable
catheter instrument.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0016] The present invention is directed to robotic catheter
systems and methods of performing various back and spinal surgical
procedures using such robotic catheter systems. Injury, aging,
improper body mechanics, and normal wear and tear can all cause
injury to the spine. And damage to any part of the back, especially
to the nerves, can cause pain and other symptoms. Although most
back problems are successfully handled with non-surgical
treatments, such as anti-inflammatory medication, ice, heat, gentle
massage or physical therapy, a percentage of back problems require
surgery for relief. For example, some of the spine conditions that
may be treated with spinal surgery include spondylolisthesis,
stenosis, degenerative disc disease, herniated disc, sciatica,
spine fractures, spine tumors, scoliosis, and osteoporosis. In
general, spine surgery may be used to help decompress a nerve root
or the spinal cord, stabilize an unstable or painful segment with
fusion surgery, or reduce a deformity.
[0017] FIGS. 1A and 1B illustrate example of embodiments of robotic
catheter systems (32) suitable for use in performing the surgical
procedures described herein. Referring first to FIG. 1A, one
embodiment of a robotic catheter system (32), includes an operator
control station (2) located remotely from an operating table (22),
and a robotic catheter assembly (1002) (also referred to as a
catheter instrument). The robotic catheter assembly (1002) is
coupled to the operating table (22) by an instrument driver
mounting brace (20). The robotic catheter assembly (1002) comprises
a robotic instrument driver (16) and an instrument (18), such as a
guide instrument (18) (also referred to herein as an instrument
guide catheter, guide catheter, robotic guide instrument, robotic
guide catheter, catheter instrument or the like). A communication
link (14) transfers signals between the operator control station
(2) and instrument driver (16). The instrument driver mounting
brace (20) of the depicted embodiment is a relatively simple,
arcuate-shaped structural member configured to position the
instrument driver (16) above a patient (not shown) lying on the
table (22).
[0018] In FIG. 1B, another embodiment of a robotic catheter system
(32) is depicted, wherein the arcuate-shaped member (20) is
replaced by a movable support assembly (26). The support assembly
(26) is configured to movably support the instrument driver (16)
above the operating table (22) in order to position the instrument
driver (16) for convenient access into desired locations relative
to a patient (not shown). The support assembly (26) in FIG. 1B is
also configured to lock the instrument driver (16) into position
once it is positioned.
[0019] The instrument (18) is typically an elongate, flexible
device configured to be inserted into a patient's body. As
non-limiting examples, an instrument (18) may comprise an
intravascular catheter, an endoscopic surgical instrument or other
medical instrument. The instrument (18) may also comprise an
instrument assembly (28) (also referred to herein as a catheter
assembly (28)) comprising a robotic guide instrument (18), or a
coaxially coupled and independently controllable robotic sheath
instrument (30) (also referred to as a sheath catheter (30)) and a
robotic guide instrument (18), as described in the U.S. Patent
Applications incorporated by reference below. The instrument (18)
or instrument assembly (28) is configured to be operable via the
instrument driver (16) such that the instrument driver (16) can
operate to steer the instrument (18) or instrument assembly (28)
and also to operate tools and devices which may be provided on the
instrument assembly (18) or instrument assembly (28) (e.g. an
imaging device or cutting tool disposed on the distal end of the
instrument (18) or instrument assembly (28)). The guide instrument
(18) may be movably positioned within the working lumen of the
sheath instrument (30) to enable relative insertion of the two
instruments (30, 18), relative rotation, or "roll" of the two
instruments (30, 18), and relative steering or bending of the two
instruments (30,18) relative to each other, particularly when a
distal portion of the guide instrument (18) is inserted beyond the
distal tip of the sheath instrument (30).
[0020] The procedures described herein may be performed with
robotically steerable instruments, such as those described in the
below-referenced patent application, U.S. patent application Ser.
No. 11/481,433.
[0021] Exemplary embodiments of an operator control station (2), an
instrument driver (16), an instrument (18) and instrument assembly
(28), a robotic sheath instrument (30), a robotic guide instrument
(18), and various instruments (50), are described in detail in the
following U.S. Patent Applications, and are incorporated herein by
reference in their entirety:
[0022] U.S. patent application Ser. Nos. 10/923,660, filed Aug. 20,
2004; 10/949,032, filed Sep. 24, 2005; 11/073,363, filed Mar. 4,
2005; 11/173,812, filed Jul. 1, 2005; 11/176,954, filed Jul. 6,
2005; 11/179,007, filed Jul. 6, 2005; 11/202,925, filed Aug. 12,
2005; 11/331,576, filed Jan. 13, 2006; U.S. Provisional Patent
Application Nos. 60/785,001, filed Mar. 22, 2006; 60/788,176, filed
Mar. 31, 2006; U.S. patent application Ser. Nos. 11/418,398, filed
May 3, 2006; 11/481,433, filed Jul. 3, 2006; 11/637,951, filed Dec.
11, 2006; 11/640,099, filed Dec. 14, 2006; and U.S. Provisional
Patent Applications Nos. 60/833,624, filed Jul. 26, 2006, and
60/835,592, filed Aug. 3, 2006.
[0023] For clarity, the sheath and guide catheter instruments
described in the exemplary embodiments below may be described as
having a single lumen/tool/end-effector, etc. However, it is
contemplated that alternative embodiment of catheter instruments
may have a plurality of lumens/tools/end-effectors/ports, etc.
Furthermore, it is contemplated that in some embodiments, multiple
catheter instruments may be delivered to a surgical site via a
single multi-lumen sheath, each of which is robotically driven and
controlled by via an instrument driver. Some of the catheter
instruments described herein, are noted as flexible. It is
contemplated that different embodiments of flexible catheters may
be designed to have varying degrees of flexibility and control. For
example, one catheter embodiment may have controlled flexibility
throughout its entire length whereas another embodiment may have
little or no flexibility in a first portion and controlled
flexibility in a second portion. Similarly, different embodiments
of these catheters may be implemented with varying degrees of
freedom.
[0024] Turning now to FIGS. 2A-2E illustrate a number of
embodiments of methods for various minimally invasive spinal
surgeries that may be performed with a robotic catheter system (32)
such as that described above and in aforementioned U.S. patent
application Ser. No. 11/481,433. Furthermore, a robotic catheter
system (32) may be used to control one or more catheter assemblies
(28) into the spine. In some embodiments, a guide catheter (18) may
be introduced into the spine without a sheath catheter (30), or
vice versa. In other embodiments, a guide catheter (18) and sheath
catheter (30) are both introduced into the spine. In alternative
embodiments, the guide and/or sheath may be used to deliver other
catheter devices or tools or end-effectors into the spine to
perform spinal surgeries. This and the surgical procedures
disclosed below may be performed with the aid of various medical
imaging modalities such as X-ray, fluoroscopy, MR, CT, ultrasound,
etc.
[0025] FIG. 2A illustrates one embodiment of a method wherein a
flexible, robotically steerable catheter (18) being driven through
the sacral hiatus and into the epidural space. FIGS. 2B-2C
illustrate the catheter (18) traveling up towards the lumbar spine
via the epidural space. FIG. 2D is a cross-sectional view of the
catheter (18) in the epidural space between the spinal cord and the
lamina of the vertebral body.
[0026] One common condition is a spinal disc herniation or more
commonly known as a slipped disc. Many types of problems can reduce
the amount of space in the spine, resulting in pinched nerves. As
people age, the spinal discs may dry out and shrink, thus reducing
their effectiveness as shock absorbers. These discs also act to
prevent the vertebrae from rubbing against each other. Throughout
the length of the spine is a central tube, surrounded by bone and
discs, called the spinal canal. Inside the spinal canal are the
spinal cord, the cauda equine, and spinal nerves. A pair of spinal
nerves brand out at each vertebral level. The intervertebral discs
lie in front of the spinal nerves and are situated between the
vertebrae. Disc herniation can occur in any disc in the spine, but
the two most common forms are the cervical disc herniation and the
lumbar disc herniation, the latter being more common, causing
lumbago and often leg pain as well. Cervical disc herniations occur
in the neck, most often between the sixth and seventh cervical
vertebral bodies. Thoracic discs are very stable and herniations in
this region are quite rare. Lumbar disc herniations occur in the
lower back, most often between the fourth and fifth lumbar
vertebral bodies or between the fifth and the sacrum. The lowermost
discs (L4/5 and L5/S1) are most prone to wear and tear and
potential rupture. Discs may also bulge or rupture, causing nearby
nerves to become irritated. Once an annular tear occurs, it may
heal or it may allow nucleus to come out of the center of the disc
into the spinal canal. This may be referred to by a variety of
terms including disc prolapse, ruptured disc, slipped disc,
extruded disc, etc. To relieve pressure on the spinal cord or
nerves, portions of bone and/or discs may need to be removed.
Lumbar discectomy is a surgical procedure to remove part of a
problem intervertebral disc in the lower back, for example, removal
of herniated disc material, usually in the lumbar region of the
spine. This procedure is commonly used when a herniated or ruptured
disc in the lower back is putting pressure on a nerve root.
[0027] The main goal of discectomy surgery is to relieve pressure
on the spinal cord or spinal nerve by widening the spinal canal or
removing the part of the disc that is putting pressure on a spinal
nerve root. Taking out the injured portion of the disc also reduces
chances that the disc will be herniated again. The two main parts
of a disc are the annulus fibrosis and the nucleus pulposus. The
lamina bone forms the protective covering over the back of the
spinal cord. A traditional procedure may consist of a laminotomy
and discectomy, but a minimally invasive method called
microdiscectomy or microendoscopic discectomy is often now
performed instead. Whereas a traditional laminotomy involves taking
off part of the lamina bone to provide greater room for the surgeon
to take out part of the disc during the discectomy, a surgeon
performs a lumbar microdiscectomy procedure through a very small
incision in the posterior region of the patient's low back directly
over the problem disc.
[0028] Typically, a small window is made on one side of a spinous
process through the removal of some bone and ligament to allow
visualization of the disc bulge and involved root. In some
procedures, the skin and soft tissues may be separated to expose
the bones along the back of the spine and a retractor used to
spread apart the lamina bones above and below the disc. Through
gentle dissection, the interface between the root and the disc
bulge is identified and the offending fragment can be removed. The
method of one embodiment involves deploying thin wires or dilators
through the incision to the region of interest. This way, a
flexible catheter or endoscope may be driven to the area. In order
to access the nerve, the lamina may be removed with a small,
high-speed drill or small bone-biting tool (Kerrison rongeur)
mounted at the distal tip of a flexible catheter. The surgeon may
also make a tiny slit in the ligamentum flavum, exposing the spinal
nerves. All the nerves, except the exciting nerve, are grouped
together in the thecal sac where they float loosely in spinal
fluid. A special hook or retractor may be placed under the spinal
nerve root to lift it so that the surgeon can see the injured disc
or source of pressure (i.e., disc fragment, osteophyte or bone
spur, protruding/degenerating disc, facet arthritis, cysts,
tumors). The outer annulus fibrosis of the disc is sliced open and
material from inside nucleus pulposus of the disc is scooped out.
Various tools may be used with the catheter to remove the ruptured
disc and other loose fragments of disc in the surrounding area.
Because only the injured portion is removed, the disc is left
intact and functioning. The surgeon may also check the spinal
nerves where they travel from the spinal canal through the neural
foramina. The surgeon inspects the area about the nerve root to
ensure that the nerve root is free to move, otherwise the neural
foramen may also be cleaned. In some instances, a spinal fusion
with instrumentation may be performed to help stabilize the spine.
A spinal fusion involves grafting a small piece of bone onto the
spine and using spinal hardware, such as screws and rods, to
support the spine and provide stability. The wound may be irrigated
with antibiotics and the catheter withdrawn. The muscles and soft
tissues are put back in place and the skin is stitched together.
The incision may be closed using either absorbable sutures or skin
sutures or Steri-Strips.
[0029] Because of the proximity of the spinal cord and associated
nerves during these types of surgical procedures, precise control
and maneuverability of any surgical tools or catheter being used is
desirable to avoid unintentional injury. The methods for a lumbar
discectomy or microdiscectomy surgical procedure such as that
described above may be performed with one or more flexible,
robotically steerable catheter instruments and robotic catheter
system such as those described in detail in U.S. patent application
Ser. No. 11/176,598, incorporated by reference herein in its
entirety. In some embodiments, the catheters may also be equipped
with a tool, illumination fiber, image capture device, laser,
irrigation port, suction port, needle, working cannula, grasper,
shaving port, blade, drill, or other end-effector, etc, but are not
limited as such. It is contemplated that other types of instruments
may be attached and/or used at the distal portion of other
embodiments of the catheter. Similarly, one or more instruments may
be deployed through the one or more lumens that may exist within
these catheters.
[0030] FIGS. 3A-3D illustrate one embodiment of a method for a
lumbar discectomy procedure using a flexible, robotically steerable
catheter (18). FIG. 3A illustrates a flexible, robotically
steerable catheter (18) being driven to a herniated disc in the
lumbar spine. Access was taken through the sacral hiatus and along
through the epidural space. FIG. 3B illustrates a needle (816)
being used to puncture the herniated disc to allow drainage. FIG.
3C illustrates removal of parts of the herniated disc. This may be
done via a variety of tools, in this case a grasper (802) is being
used. FIG. 3D illustrates a catheter (18) with a working lumen
through which a variety of treatments can be applied: suction,
drainage, lavage, and/or delivery of medication.
[0031] Laminectomy is a surgical procedure for treating spinal
stenosis or neural impingement by relieving pressure on the spinal
cord. Laminectomy involves the removal of the lamina area of the
vertebral body to alleviate spinal stenosis, i.e. numbness in the
legs. Conditions such as spinal stenosis or spondylolisthesis may
be remedied with a lumbar laminectomy. The lamina of the vertebra
is removed or trimmed to widen the spinal canal and create more
space for the spinal nerves. A laminectomy is often performed to
permit removal of, or reshaping of, a spinal disc as part of a
lumbar discectomy as described above. Note that laminotomy and
laminectomy are both surgical procedures involving the lamina, the
thin bony layer covering the spinal canal. During back surgery,
this lamina may obstruct the viewing of an intervertebral disc. In
contrast to a laminotomy procedure, which involves the partial
removal of the lamina, a laminectomy procedure involves the
complete removal of the lamina.
[0032] During a laminectomy, a patient is lying prone on the
operating table. The skin and muscle are cut to obtain access to
the vertebrae. A flexible catheter may be inserted into the opening
to remove the lamina. By using a catheter to perform the procedure,
the size of the incision necessary and the resulting trauma to the
patient may be reduced. Depending on the particular situation, the
surgeon may continue to drive the robotically controlled catheter
about the vertebrae to trim protruding bits of a herniated disc as
discussed above. Once the surgery is completed, the muscle and skin
are sutured close.
[0033] FIGS. 4A-4D illustrate one embodiment of a method for a
lumbar laminectomy procedure using a flexible, robotically
steerable catheter (18). As discussed above, different embodiments
of a catheter may be equipped with various types of tools at the
distal end and a varying number of through lumens may be provided.
FIG. 4A illustrates a flexible, robotically steerable catheter (18)
being driven through the epidural space to the area of treatment
for spinal stenosis. FIG. 4B illustrates a drill bit tip (996) and
a router bit tip (995) which can be advanced via a catheter (18) to
the area of treatment and used to remove the lamina. FIG. 4C
illustrates removal of part of the lamina using the router bit tip
(995) to relieve pressure on the spinal cord. FIG. 4D illustrates a
posterior view of the spine with the removed section of lamina.
[0034] Foraminotomy is a surgical operation for relieving pressure
on nerves that are being compressed by the intervertebral foramina.
Foraminotomy involves the removal of bone material along the spine
to take pressure off the spinal nerve, thereby alleviating a spinal
stenosis. The intervertebral foramina are passages through the
bones of the vertebrae that pass nerve bundles to the body from the
spinal cord. During a foraminotomy, the passageway may be enlarged
to ease the pressure on a nerve. In some instances, a foraminotomy
may be combined with other procedures such as a laminotomy or
laminectomy. One type of foraminotomy is a keyhole foraminotomy.
This is a minimally invasive procedure in which an incision is made
in the back of the neck or another posterior position of the
patient's back. The muscle is peeled away to reveal the bone
underneath and a small hole is cut into the vertebra. A flexible
catheter may be inserted through this opening to visualize the
foramen and to remove the impinging bone or disk material. Special
cutting instruments and/or a drill may be used to remove bone
spurs, thickened ligaments, and debris. The process of nerve root
decompression comprises removing these tissues from the
neuroforamen to increase the space for the nerve root. In some
instances, cortisone may also be applied over the nerve root via a
port on the flexible catheter. Once pressure on the nerve is
released, the catheter instrument may be withdrawn and the muscles
move back into place. The incision may be closed using absorbable
sutures, Steri-Strips, non-absorbable sutures, surgical staples,
etc. Foraminotomy procedures may be used to treat conditions
including: foraminal stenosis, herniated disc, bulging disc,
pinched nerve or nerve root compression, scar tissue formation,
bone spurs, arthritis of the spine, and sciatica.
[0035] FIGS. 5A-5E illustrate one embodiment of a method for a
foraminotomy procedure using a flexible, robotically steerable
catheter (18). As discussed above, different embodiments of a
catheter may be equipped with various types of tools at the distal
end and a varying number of through lumens may be provided. FIG. 5A
illustrates a flexible, robotically steerable catheter (18) being
driven through the epidural space to the area of treatment to
remove pressure off the spinal nerve. FIG. 5B illustrates a drill
bit tip (996) and a router bit tip (995) which can be driven via a
catheter (18) to the area of treatment. FIG. 5C is a
cross-sectional view of the removal of bone material to alleviate
pressure on the spinal nerve. FIG. 5D is a side view of the router
bit tip catheter tool (995) being used to remove bone material.
FIG. 5E is a posterior view of the spine showing the removed
section of bone material to allow room for the spinal nerve.
[0036] A common technique for correcting spinal problems is spinal
fusion, which essentially welds or couples together specific bony
segments of the spine to enhance bone growth into a solid and
stable construct. The spinal fusion may be facilitated by the
delivery of a spinal stabilization device. Spinous processes are
located in the very back of the spinal column near the skin
surface. A wide variety of spinal stabilization devices have been
developed to facilitate spinal fusion. For example, these devices
may include special plates, rods (i.e., Harrington or Knodt rods),
hooks, screws, spacers, crosslinking devices, and many others.
There are also several types of interspinous devices on the market
including the X-STOP Interspinous Process Decompression device made
by St. Francis Medical Technologies of Concord, Calif., the Wallis
Mechanical Normalization device of Abbott Spine of Austin, Tex.,
the DIAM Spinal Stabilization System available from Medtronic
Sofamor Danek of Memphis, Tenn., and the Coflex Interspinous
Implant available from Paradigm Spine of New York, N.Y., all of
which may be surgically implanted into a patient with the use of a
flexible, robotically controlled catheter instrument and
system.
[0037] With a minimally invasive surgical procedure, one or more
interspinous process spacers may be implanted to open the foramen,
thus relieving the nerve endings and unloading the intervertebral
discs. A surgeon may utilize a catheter device to access the
surgical space on the spine and to deliver one or more
stabilization devices. In some situations, a plurality of catheter
devices may be utilized to perform the device implant or
installation.
[0038] One situation wherein a method for spinal fusion may be used
is a discectomy procedure that actually removes an intervertebral
disc because the herniated disc is so badly damaged. After the disc
is removed, a spinal instrumentation and fusion procedure may be
performed to restore the lost disc height as a result of the
removed disk and to join the adjacent vertebrae together to
stabilize those segments of the spine. A low profile segmental
spinal instrumentation system such as the X10 Crosslink Plate
Spinal System also available from Medtronic Sofamor Danek of
Memphis, Tenn. may be deployed with a flexible catheter in one
embodiment. Crosslinking devices are transverse implants that
connect an implanted rod on one side of the spine to an implanted
rod on the other side. In some instances, a drill or scraper at the
distal tip of the catheter may remove an amount of bone from the
spinal segment so that the crosslinking devices or bone graft may
be implanted.
[0039] Another method for spinal stabilization is a DIAM Spinal
Stabilization System available from Medtronic Sofamor Danek. The
DIAM system is an alternative to spinal fusion. Through a small
incision, a flexible catheter may be used to insert an H-shaped
silicone DIAM implant between two spinous processes to treat spinal
stenosis. The outer mesh band and tether of the DIAM implant are
fabricated from polyester and the crimp is made of titanium.
Because the implant device is available in a variety of sizes to
accommodate individual patient anatomy, different embodiments of a
flexible catheter may be adapted to handle different devices. For
example, one implementation of a catheter may be designed to handle
multiple models of an implant device.
[0040] FIGS. 6A-6D illustrate one embodiment of a method for
delivering a spinal stabilization (993) device using a flexible,
robotically steerable catheter (18). As discussed above, different
embodiments of a catheter may be equipped with various types of
tools at the distal end and a varying number of through lumens may
be provided. FIG. 6A illustrates a flexible, robotically steerable
guide catheter (18) entering the interstitial space between two
spinous processes. FIG. 6B illustrates the catheter (18) with an
inflatable/fillable pre-formed spinal stabilization device (993)
being inserted into the interstitial space between the two spinous
processes. FIG. 6C illustrates the inflated/filled device (993)
being deployed and taking shape between the two spinal processes.
FIG. 6D illustrates a posterior view of the spinal stabilization
device (993) fully inflated/filled and in place between the two
spinous processes.
[0041] One minimally invasive surgical technique for stabilizing
fractured vertebra is a vertebroplasty procedure wherein bone
cement is percutaneously injected into a fractured vertebra.
However, a kyphoplasty procedure developed primarily by Kyphon Inc.
of Sunnyvale, Calif. has improved upon that. Kyphoplasty is a
treatment of osteoporotic vertebral compression fractures (VCF)
using balloon catheters. Kyphoplasty is a minimally invasive spinal
surgery procedure where the original height and angle of kyphosis
of a fractured vertebra may be restored, followed by its
stabilization using injected bone filler material.
[0042] Kyphoplasty is generally used to treat painful progressive
vertebral body collapse/fractures (VCFs), which may be caused by
osteoporosis or the spread of tumor to the vertebrae body. Some
vertebral compression fractures (VCFs) are clinically unstable.
Some VCFs may involve significant loss of function due to bone
pressing on the spinal cord or spinal nerves. Kyphoplasty is
designed to stop the pain caused by the bone fracture, to stabilize
the bone, and to restore some or all of the lost vertebral body
height due to the compression fracture. In a number of
applications, the height and angle restoration is accomplished
through hydraulic or mechanical intravertebral expansion.
[0043] During a kyphoplasty procedure, one or more small incisions
are made on the patient's back. One or more catheters with a
through lumen is inserted into the vertebral body and a balloon is
deployed at the distal tip. The balloon is inflated via a port on
the catheter, thus pushing the bone back towards its normal height
and shape. Once a cavity is created, the inflatable balloon bone
tamp may be removed. Bone cement is then delivered through a
catheter instrument to fill the cavity. For one embodiment, the
bone cement is comprised of a vinyl polymer such as polymethyl
methacrylate (PMMA). The catheters and surgical instruments are
removed from the patient and the incisions closed.
[0044] One of the perceived benefits of kyphoplasty over
vertebroplasty is that kyphoplasty uses a balloon to create a void
in the cancellous part of the collapsed vertebral body that can
then be filled with a more viscous bone cement. The viscous
properties of this bone cement decrease the likelihood that the
cement will leak out of the vertebral body and affect other parts
of the vertebra, especially the spinal cavity which contains the
sensitive spinal nerves. Inflating the balloon within the bone can
also help reduce the deformity created by the collapsed bone, as
the balloon helps restore some or most of the vertebral height and
shape. By restoring some percentage of the vertebral body's
pre-fracture height, it may be possible to alleviate some of the
pain caused by compression of the thoracic cavity.
[0045] FIGS. 7A-7F illustrate one embodiment of a method for a
kyphoplasty procedure using a flexible, robotically steerable
catheter (18). In this example, the procedure is performed with a
sheath catheter (30) and a guide catheter (18) instrument set. As
discussed above, different embodiments of a catheter may be
equipped with various types of tools at the distal end and a
varying number of through lumens may be provided. FIG. 7A
illustrates a small hole being drilled into the affected vertebra
with an end-effector (19) mounted to the distal tip of a flexible,
robotically steerable catheter (18). FIG. 7B illustrates insertion
of a balloon (102) through a flexible, robotically steerable
catheter (18) into the hole. FIG. 7C illustrates inflation of the
balloon (102) to create a void and to return the affected vertebra
to its proper position/height. FIG. 7D illustrates the deflated
balloon catheter (102) being removed and leaving behind a
cavity/void to be filled within the affected vertebra. FIG. 7E
illustrates the void being filled with a material such as bone
cement via the working lumen of a catheter (18). FIG. 7F
illustrates the finished view of the hardened material in the void
to restore the affected vertebra to its original position.
[0046] As disclosed above, minimally invasive procedures such as
vertebroplasty or kyphoplasty have been performed to remedy VCFs.
These procedures use an injection of bone cement to support the
vertebra. While these procedures have been effective for many
patients, some procedures have also resulted in unintended events
including cement leakage, toxicity reactions, and an increased
potential for fracture of an adjacent vertebral body.
[0047] An alternative minimally invasive spinal repair technique is
a spineoplasty developed by Spineology of St. Paul, Minn.
Spineoplasty is a minimally invasive procedure that uses the
OptiMesh Deployable Grafting System and biologically-friendly bone
graft. Spineoplasty is similar to Kyphoplasty, but this time the
void/cavity is dug out and a mesh bag (such as an Optimesh device,
described below) is inserted. The bag is filled with bone graft
material and left in the cavity to harden.
[0048] The OptiMesh, also available from Spineology, is a
three-dimensional deployable mesh pouch for implantation into
skeletal defects. Once implanted into place, the empty pouch is
filled to the desired size. By using bone graft instead of bone
cement, the center of the vertebra is allowed to heal. In
Spineoplasty, the OptiMesh implant contains the graft, enabling the
graft to potentially reduce deformity and support the vertebra. The
contained bone graft, in addition to having the potential to
incorporate, provides support to the vertebral body that can
significantly reduce pain and increase mobility while healing
occurs. With a spineoplasty, the size and shape of the damaged
vertebra may be restored.
[0049] FIGS. 8A-8E illustrate one embodiment of a method for a
spineoplasty procedure using a flexible, robotically steerable
catheter (18). As discussed above, different embodiments of a
catheter may be equipped with various types of tools at the distal
end and a varying number of through lumens may be provided. The
patient is sedated and lies prone on the surgical bed. A very small
incision is made along the spine. A catheter (18) is inserted
through the incision to create a cavity in the vertebra. FIG. 8A
illustrates a small hole being drilled into the affected vertebra
with a drill bit (996) mounted on the distal tip of a flexible,
robotically steerable catheter (18). FIG. 8B illustrates a cavity
being created using router bit tip (995) on the end of the flexible
catheter (18) through the hole. In alternative embodiments, a
cavity may be created with an expanding shape tool or a bone
scraper. FIG. 8C illustrates the delivery of the OptiMesh pouch
device (994) into the cavity via the robotically controlled
catheter (18) inserted through the hole. The empty OptiMesh pouch
device (994) is implanted into position. FIG. 8D illustrates the
OptiMesh device (994) being filled with bone graft material (21)
via the working lumen of the catheter (18). The mesh pouch (994) is
inflated with bone graft to support the damaged vertebra and then
released. FIG. 8E illustrates the cavity filled by the OptiMesh
pouch being allowed to harden and also shows the removal of the
catheter (18).
[0050] While multiple embodiments and variations of the many
aspects of the invention have been disclosed and described herein,
such disclosure is provided for purposes of illustration only. Many
combinations and permutations of the disclosed system are useful in
minimally invasive surgery, and the system is configured to be
flexible. While multiple embodiments and variations of the many
aspects of the invention have been disclosed and described herein,
such disclosure is provided for purposes of illustration only. Many
combinations and permutations of the disclosed system are useful in
minimally invasive surgery, and the system is configured to be
flexible. Many combinations and permutations of the disclosed
system are useful in minimally invasive surgery, and the system is
configured to be flexible, and it should be understood that the
invention generally, as well as the specific embodiments described
herein, are not limited to the particular forms or methods
disclosed, but also cover all modifications, equivalents and
alternatives falling within the scope of the appended claims.
* * * * *