U.S. patent application number 15/174345 was filed with the patent office on 2016-09-29 for endoscopic soft tissue working space creation.
This patent application is currently assigned to Amendia, Inc.. The applicant listed for this patent is Amendia, Inc.. Invention is credited to Said G. Osman.
Application Number | 20160278758 15/174345 |
Document ID | / |
Family ID | 43857079 |
Filed Date | 2016-09-29 |
United States Patent
Application |
20160278758 |
Kind Code |
A1 |
Osman; Said G. |
September 29, 2016 |
ENDOSCOPIC SOFT TISSUE WORKING SPACE CREATION
Abstract
A device for creating endoscopic operating space includes an
external cannula, an internal cannula disposed in the external
cannula, and an expandable retractor disposed at a distal end of
the device and cooperable with the external cannula and the
internal cannula. The expandable retractor is displaceable between
an unexpanded position and an expanded position. An actuator is
cooperable with the expandable retractor to displace the expandable
retractor between the unexpanded position and the expanded
position.
Inventors: |
Osman; Said G.; (Frederick,
MD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Amendia, Inc. |
Marietta |
GA |
US |
|
|
Assignee: |
Amendia, Inc.
Marietta
GA
|
Family ID: |
43857079 |
Appl. No.: |
15/174345 |
Filed: |
June 6, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13500330 |
Apr 5, 2012 |
9370379 |
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PCT/US2010/051404 |
Oct 5, 2010 |
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15174345 |
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61248664 |
Oct 5, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00557
20130101; A61B 2017/3484 20130101; A61B 17/0218 20130101; A61B
17/3421 20130101 |
International
Class: |
A61B 17/02 20060101
A61B017/02; A61B 17/34 20060101 A61B017/34 |
Claims
1. A device for creating endoscopic operating space, the device
comprising: an external cannula; an internal cannula disposed in
the external cannula; an expandable retractor disposed at a distal
end of the device and cooperable with the external cannula and the
internal cannula, the expandable retractor being displaceable
between an unexpanded position and an expanded position; an
actuator cooperable with the expandable retractor, the actuator
displacing the expandable retractor between the unexpanded position
and the expanded position, wherein the internal cannula is
displaceable longitudinally relative to the external cannula, and
wherein the actuator displaces the internal cannula relative to the
external cannula to thereby displace the expandable retractor
between the unexpanded position and the expanded position; and
wherein the expandable retractor comprises a plurality of
extensions secured to a distal end of the internal cannula, a cap
secured over a distal end of the external cannula and having
through holes through which the plurality of extensions are
movable, and a membrane positioned over the cap, wherein in the
unexpanded position, distal ends of the extensions are positioned
flush with or adjacent the cap and the membrane is collapsed, and
wherein in the expanded position, the internal cannula is
longitudinally displaced relative to the external cannula, the
extensions are positioned through the through holes, and the
membrane is expanded and covering the extensions.
2. A device according to claim 1, wherein the expandable retractor
comprises a first part-cone member secured to a distal end of the
external cannula and a second part-cone member secured to a distal
end of the internal cannula, the first and second cone members
being secured to each other at distal ends thereof.
3. A device according to claim 2, wherein at least the second cone
member comprises reinforcing ribs.
4. A device according to claim 3, wherein the retractor is formed
of a synthetic fabric or a metal alloy or another biologically
compatible material.
5. A device according to claim 1, wherein the actuator comprises
threads at a proximal end of the internal cannula and a mechanical
expander engaging the threads, wherein rotation of the mechanical
expander effects longitudinal displacement of the internal cannula
relative to the external cannula.
6. A device according to claim 1, wherein the expandable retractor
comprises an extension of the external cannula, wherein a proximal
end of the extension includes an inside diameter that is narrower
than an outside diameter of the internal cannula, and wherein the
internal cannula is longitudinally displaced relative to the
external cannula, and the internal cannula engages the proximal end
of the extension to displace the expandable retractor to the
expanded position.
7. A device according to claim 1, wherein the external cannula and
the internal cannula are formed in one piece with a channel
therebetween, and wherein the expandable retractor comprises a
balloon attached to a distal end of the external and internal
cannula.
8. A device according to claim 7, wherein the actuator comprises a
source of fluid in fluid communication with the balloon via the
channel.
9. A device according to claim 8, wherein a wall of the balloon has
a varied thickness such that when the balloon is inflated to the
expanded position, a distal surface of the balloon expands less
than a proximal wall of the balloon.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a division of co-pending U.S.
application Ser. No. 13/500,330 with is the U.S. national phase of
International Application No. PCT/US2010/051404 filed 5 Oct. 2010
which designated the U.S. and claims priority to U.S. Provisional
Patent Application Ser. No. 61/248,664 filed 5 Oct. 2009, the
entire contents of each of which are hereby incorporated by
reference.
BACKGROUND OF THE INVENTION
[0002] Most endoscopic procedures involve operation in natural
cavities. Examples include laparoscopy, thoracoscopy, cystoscopy,
arthroscopy, bronchoscopy, esophago-gastro-duodenoscopy,
colonoscopy, colopscopy and hysteroscopy. Most other procedures,
until recently have been performed through formal open procedures.
Arthroscopy of the intervertebral disc has been practiced for
nearly three decades now, but the disc space is a syndesmosis and
lacks joint cavity. Attempts have been made to create an operating
space in the retroperitoneal area to perform minimally invasive
fusion of the lumbar spine. Arthroscopic Subacromial decompression
is not an intra-cavitary procedure although one may start in the
subacromial bursa.
[0003] With the successes of endoscopic procedures in most
specialties of surgery, there is an increasing demand by patients
for less invasive procedures, and efforts are being made by
specialists in all surgical fields to find ways to satisfy this
demand. When successful, the benefits are tremendous: the surgical
time may be drastically reduced; surgical trauma is invariably less
with endoscopic approaches; intra-operative and post-operative
blood loss is usually minimal; hospital stay is short;
rehabilitation is short and more complete than in cases of
conventional procedures; the need for pain medication is less both
in terms of the strength and duration of the medication; and return
to productive activities is much earlier in most cases. In areas
where there is no natural cavity, mini-open procedures are often
performed to minimize surgical trauma and blood loss, but the
trade-off may be a technically difficult procedure with less than
satisfactory median or long term clinical outcome. While not always
feasible, a new approach whereby an artificial working space is
created to mimic a natural cavity, where one does not exist, is
possible in many areas especially in the field of orthopedic and
spine surgery, to facilitate endoscopic procedures such as anterior
and posterior cervical spine procedures; posterolateral fusion of
the lumbar spine, bone grafting of non-unions, repair of ruptured
tendons and similar procedures.
SUMMARY OF THE INVENTION
[0004] The device according to described embodiments provides for
minimally invasive operating space. In one arrangement, the device
may include a cannula with an expandable retractor at one end. The
external end is equipped with gadgets currently used for endoscopic
procedures. A similar device may be inserted from the opposite side
such that the two cannulas are in contact or nearly in contact at
the site of the desired working space. Once inside the body--in the
required location--the retractors are expanded, and traction is
applied to each cannula in the opposite direction to create a
cylindrical space between them. The traction on each cannula is
maintained using a variety of techniques. The tubular space in the
cannulas is then used as the access portal for the endoscope and
instruments to perform the intended procedure.
[0005] In an exemplary embodiment, a device for creating endoscopic
operating space includes an external cannula, an internal cannula
disposed in the external cannula, and an expandable retractor
disposed at a distal end of the device and cooperable with the
external cannula and the internal cannula. The expandable retractor
is displaceable between an unexpanded position and an expanded
position. An actuator is cooperable with the expandable retractor
to displace the expandable retractor between the unexpanded
position and the expanded position.
[0006] In one arrangement, the internal cannula is displaceable
longitudinally relative to the external cannula, and the actuator
displaces the internal cannula relative to the external cannula to
thereby displace the expandable retractor between the unexpanded
position and the expanded position. In this context, the expandable
retractor may include a first part-cone member secured to a distal
end of the external cannula and a second part-cone member secured
to a distal end of the internal cannula, where the first and second
cone members are secured to each other at distal ends thereof.
Still further, the actuator may include threads at a proximal end
of the internal cannula and a mechanical expander engaging the
threads, where rotation of the mechanical expander effects
longitudinal displacement of the internal cannula relative to the
external cannula. At the second cone member may include reinforcing
ribs. Preferably, the retractor is formed of a synthetic fabric or
a metal alloy or another biologically compatible material.
[0007] In another arrangement, the expandable retractor includes a
plurality of extensions secured to a distal end of the internal
cannula, a cap secured over a distal end of the external cannula
and having through holes through which the plurality of extensions
are movable, and a membrane positioned over the cap. In the
unexpanded position, distal ends of the extensions are positioned
flush with or adjacent the cap and the membrane is collapsed. In
the expanded position, the internal cannula is longitudinally
displaced relative to the external cannula, the extensions are
positioned through the through holes, and the membrane is expanded
and covering the extensions.
[0008] The expandable retractor may alternatively include an
extension of the external cannula, where a proximal end of the
extension includes an inside diameter that is narrower than an
outside diameter of the internal cannula.
[0009] When the internal cannula is longitudinally displaced
relative to the external cannula, the internal cannula engages the
proximal end of the extension to displace the expandable retractor
to the expanded position.
[0010] The external cannula and the internal cannula may be formed
in one piece with a channel therebetween, where the expandable
retractor includes a balloon attached to a distal end of the
external and internal cannula. In this context, the actuator may
include a source of fluid in fluid communication with the balloon
via the channel. Moreover, a wall of the balloon may have a varied
thickness such that when the balloon is inflated to the expanded
position, a distal surface of the balloon expands less than a
proximal wall of the balloon.
[0011] Preferably, the external cannula and the internal cannula
are formed of a metal alloy or a biocompatible plastic
material.
[0012] In another exemplary embodiment, a method of creating
endoscopic operating space using the device of the described
embodiments includes the steps of, with the expandable retractor in
the unexpanded position, positioning the device within a tissue
space in which the endoscopic operating space is to be created;
displacing with the actuator the expandable retractor to the
expanded position; and applying traction to the device with the
expandable retractor in the expanded position. The method may
further include positioning a second one of the device on an
opposite side in the tissue space, where the step of applying
traction includes applying traction to both devices in opposite
directions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] These and other aspects and advantages will be described in
detail with reference to the accompanying drawings, in which:
[0014] FIGS. 1A and 1B show a first exemplary embodiment of the
device for creating endoscopic operating space, FIGS. 1A1 and 1B1
show respective end views of FIGS. 1A and 1B;
[0015] FIGS. 2A and 2B show an embodiment with a membrane over the
extension members;
[0016] FIGS. 3A and 3B show an embodiment where the retractor is an
extension of the external cannula; and
[0017] FIGS. 4A and 4B show an embodiment using a balloon
retractor, FIGS. 4A1 and 4B 1 show respective end views of FIGS. 4A
and 4B.
DETAILED DESCRIPTION OF THE INVENTION
[0018] The device of the described embodiments includes a cannula
with a distal end (the end inside the body) which is armed with an
expandable retractor, and the proximal end (the end outside the
body) which is armed with gadgets such as irrigation/suction
portal, and water-seal to prevent back-leakage of the irrigation
fluid. In a preferred embodiment, referring to FIGS. 1A, 1A1 and
1B, 1B1 the cannula system 10 is made of an external cannula 12 and
an internal cannula 14 which may be made out of a metal alloy or a
biocompatible plastic material. The two cannulas 12, 14 fit into
each other. At the distal ends, the cannulas are attached to the
retractor 16 which, in an unexpanded state is folded in a manner
similar to a non-deployed umbrella. The retractor 16 is made of two
cones, one 18 fitting inside the other 20, and with the tips or
summits cut off (i.e., part-cones) to permit attachments to the
distal ends of the two cannulas 12, 14, which are fitted into each
other. The distal ends of the cones 18, 20, i.e., the bases, are
attached to each other by any technique currently in general
practice, such that the junction will act as a hinge around which
the expansion and closure of the retractor 16 can take place.
Further, the walls of the retractor 16 may be reinforced radially
with ribs 22 made of the same or different material as the
retractor. The wall of the retractor 16 may be made of a synthetic
fabric or metal alloy or any other material that is biologically
compatible.
[0019] Near the proximal end of the inner cannula 14, at its point
of exit from the outer cannula 12, the inner cannula 14 is
threaded. The threads 24 fit into the threads of a mechanical
expander 26, which is attached to the outer cannula 12, but allowed
to freely rotate on it without being decoupled from it. Hence, by
spinning the mechanical expander 26 in one direction, the inner
cannula 14 extends beyond the distal end of the outer cannula 12
forcing the retractor 16 to expand. Conversely, by spinning the
expander 26 in the opposite direction, the retractor 16 folds like
a non-deployed umbrella. Any other mechanism of expansion/closure
may be used to achieve the desired goal of expansion and folding of
the retractor 16. Moreover, threads acting as guy-ropes running
inside tubular channels in the wall of a single cannula can achieve
the same goal.
[0020] In another embodiment, with reference to FIGS. 2A and 2B,
the retractor 116 comprises a plurality of extensions attached to
the distal end of the inner cannula 114. The tips of the extensions
exit through holes in a cap 128 secured to the distal end of the
outer cannula 112. In the non-deployed state, the tips of the
extensions are not protruding out of the outer cannula cap 128 but
are flush with or adjacent its wall. Tips of the retractor 116 are
attached to a membrane 130 of fine synthetic fabric, which may be
made in the shape of a cone with the base attached to the retractor
tips and the narrower end attached to the outer wall of the outer
cannula 112. The retractor 116 may be deployed into expansion by
using the same or similar mechanism 24, 26 as described in the
first embodiment. As the device is protracted, the membrane 130 is
pulled up from a collapsed position and draped over the extending
retractor 116 into an extended position. The synthetic membrane 130
is designed to prevent intrusion of the soft tissue between the
radially arranged ribs of the retractor. The cap 128 on the end of
the outer cannula 112 is open-ended such than the cannulated device
can be used as an operating channel.
[0021] In another embodiment, with reference to FIGS. 3A and 3B,
the retractor 216 may be the extension of the outer cannula 212.
The cylindrical extension may be split vertically into a plurality
of extension pieces and joined to the end of the cannula by a
variety of methods which permit rotation of the pieces in a manner
that widens or narrows the diameter of the retractor. Proximal ends
215 of the extensions are arranged such that the diameter is
smaller than the inner cannula diameter, and cover the distal end
of the inner cannula 214, such that when the inner cannula 214 is
advanced distally by the mechanism previously described, the
individual extensions will rotate outward retracting the
surrounding tissues. The individual extension may be joined to its
neighbors with membranes made out of fine but strong synthetic
fabrics.
[0022] In yet another configuration, with reference to FIGS. 4A,
4A1 and 4B, 4B1, the cannulas are combined to act as a single
cannula 312 with a balloon 316 attached at its distal end, which
may be used to create soft tissue distraction. The balloon 316 is
in fluid communication with an inflation/deflation channel 332
which runs in the wall of the cannula 312 and exits at some
distance from the proximal tip of the cannula. The channel 332 ends
in a nozzle with a Leur lock and is attached to a fluid source 334
such as syringe. Fluid or air may be used to inflate the retractor
316. The balloon, which is preferably made out of a biocompatible
synthetic material, has a wall which is differentially thickened
such that when it is inflated, its distal wall 336 stretches less
than the proximal wall 338, such that when inflated its distal
surface remains relatively flat. Two cannulas may be deployed into
the desired area, and after inflation, a three-way valve is
deployed to maintain the inflation. Traction is applied in opposite
directions to create a cylindrical working space between them.
[0023] A variation of the above concept involves embedding the
balloon in the wall of the cannula near its distal end. The
inflation channel runs from the interior of the balloon, inside the
cannula wall and exits the wall near the proximal end of the
cannula where it ends in a nozzle. When inflated, the balloon forms
a ring near the distal end of the cannula, performing the task of
retraction. A further variation of this embodiment is where the
balloon, in a cylindrical configuration, overlies the distal end of
the cannula. It is covered by strips of material of which the wall
is made. The strips proximally form junctions with the cannula
wall, and are free-ended distally. When the balloon is inflated,
the extension strips open up, retracting the soft tissue.
APPLICATION OF THE INVENTION
[0024] Generically, the device may be applied in any tissue space
as long as the anatomy permits, but two applications in the spine
are described here.
[0025] A. Postero-lateral endoscopic fusion of the lumbar spine.
The patient is prepared for surgery in the routine fashion and
after induction of endotracheal anesthesia, is placed in prone
position on the operating table.
[0026] a. Fluoroscopic imaging is used to locate the level of the
target transverse processes. The levels are marked on both sides of
the spine.
[0027] b. Portal sites are chosen on each side of the mid-line such
that instrumentation through the sites will permit triangulation at
the mid-point between the transverse processes.
[0028] c. Tissue dilators are inserted through the portals, aiming
the tips of the dilators to the mid-point of the inter-transverse
line.
[0029] d. Two cannulas bearing the retractors in a non-expanded
state are introduced over the dilators into the inter-transverse
position.
[0030] e. The retractors are deployed in the manner described
above, depending on the design.
[0031] f. Manual traction of the cannulas is performed in opposite
directions to create a cylindrical space between the ends of the
cannulas. Traction of each cannula is maintained by application of
a stopper on the cannula at the level of the skin or by attaching
the cannula to a holding frame, which in turn may be attached to
the operating table or through an adhesive or other means to the
patient's torso.
[0032] g. The dilators are removed, and the irrigation and suction
systems are attached to the cannulas as is currently practiced in
arthroscopy.
[0033] h. The arthroscope is inserted through one portal, and the
instruments through the other.
[0034] i. The soft tissue may be debrided from the intertransverse
space, the transverse processes and the lateral walls of the
superior articular processes with graspers, shavers, and diathermy.
Subperiosteal dissection of the transverse processes and the
neighboring bony structures is performed with curettes and other
appropriate instruments.
[0035] j. Automated tools such as diamond burrs and manual
instruments such as fine gauges may be used to decorticate the
graft bed.
[0036] k. The arthroscope and the instruments may be transposed to
accomplish this task.
[0037] l. The graft material (autogenous bone, allografts and bone
substitutes) may then be laid on the prepared graft bed. Similar
procedures may be repeated for the contralateral side.
[0038] It is to be noted that the same portals may be used for
minimally decompressing the foraminal and the spinal canals. By the
same token, the same portals may be used to implant the pedicle
screws using minimally invasive approach. Thus, through two or
three small incisions--each one centimeter or less--decompression
of the spine; posterolateral fusion; and pedicle screw implantation
may be accomplished.
[0039] B. Retro-pharyngeal/esophageal Endoscopic Cervical Spine
Procedures.
[0040] Because of the overhang by the lateral masses, the vertebral
artery which runs through the foramen transversoria, the
disproportionately large cervical nerve roots as compared to the
sizes of the cervical discs, and the uncinate process which
obstruct access to the posterolateral corner of the cervical
intervertebral discs, the posterolateral arthroscopic approach to
the cervical spine is simply impractical and dangerous. The
anterolateral approach, on the other hand, is practical and is
currently used for simple discectomies and annuloplasties. In the
current invention, the following is an exemplary method of practice
for both intra-discal and prevertebral procedures:
[0041] a. The patient is placed in supine position with a bolster
between the shoulder blades to place the neck in extension.
[0042] b. The fluoroscope is angulated in the cephalo-caudal
direction to visualize the target disc space in the plane parallel
to its inclination.
[0043] c. Portal sites are marked under fluoroscopic control on
either side of the midline, as currently practiced.
[0044] d. A stab incision is made at the selected portal site, and
a spinal needle is introduced as currently practiced.
[0045] e. The stylet is removed, and the guide wire is introduced
into the disc through the spinal needle.
[0046] f. The dilator and the cannula are inserted over the guide
wire until the disc is contacted.
[0047] g. For intra-discal procedures, the guide-wire and the
dilator are removed while holding the cannula in place against the
annulus, and trephine is used to perform annulotomy.
[0048] h. The cannula is docked into the disc under fluoroscopic
control, and the necessary intra-discal procedure is performed.
[0049] i. For the retro-esophagial/prevertebral procedures, the
cannula is pulled out of the disc and the retractor is deployed as
described above, or if the cannula is not armed with the retractor,
an exchange of the cannulas is performed over the re-introduced
dilator - replacing a plain cannula with one armed with a
retractor.
[0050] j. Having deployed the cannula-retractor system bilaterally,
traction is applied as previously described to create a cylindrical
space between the two retractors.
[0051] k. The athroscope is introduced through one portal and the
instruments through the other after establishing the
irrigation/suction system.
[0052] l. Pre-vertebral steps in the procedure may now be
undertaken--e.g. anchoring of an intra-discal device, removal of
osteophytes or other structures.
[0053] This approach may be used to perform thyroidectomies and
similar procedures in the neck.
[0054] While the invention has been described in connection with
what is presently considered to be the most practical and preferred
embodiments, it is to be understood that the invention is not to be
limited to the disclosed embodiments, but on the contrary, is
intended to cover various modifications and equivalent arrangements
included within the spirit and scope of the appended claims.
* * * * *