U.S. patent application number 15/501280 was filed with the patent office on 2017-08-03 for surgical access retractor.
The applicant listed for this patent is Paul S. D'URSO. Invention is credited to Paul S. D'URSO.
Application Number | 20170215857 15/501280 |
Document ID | / |
Family ID | 55262922 |
Filed Date | 2017-08-03 |
United States Patent
Application |
20170215857 |
Kind Code |
A1 |
D'URSO; Paul S. |
August 3, 2017 |
SURGICAL ACCESS RETRACTOR
Abstract
There is provided a patient specific access retractor for use in
surgery, for example, minimally invasive spinal surgery. There are
also provided methods of using the access retractor in surgery.
Inventors: |
D'URSO; Paul S.; (Richmond,
Victoria, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
D'URSO; Paul S. |
Richmond, Victoria |
|
AU |
|
|
Family ID: |
55262922 |
Appl. No.: |
15/501280 |
Filed: |
May 20, 2015 |
PCT Filed: |
May 20, 2015 |
PCT NO: |
PCT/AU2015/050258 |
371 Date: |
February 2, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00022
20130101; A61B 2217/005 20130101; A61B 90/39 20160201; A61B
2017/00526 20130101; A61B 2090/3966 20160201; A61B 17/02 20130101;
A61B 2017/0256 20130101; A61B 2018/00595 20130101; A61B 17/0218
20130101; A61B 17/025 20130101; A61B 2034/105 20160201; A61B
5/04001 20130101; A61B 34/10 20160201; A61B 2017/00893 20130101;
A61B 2217/007 20130101; A61B 34/20 20160201; A61B 2017/00889
20130101; A61B 2034/2065 20160201 |
International
Class: |
A61B 17/02 20060101
A61B017/02; A61B 34/20 20060101 A61B034/20; A61B 5/04 20060101
A61B005/04; A61B 34/10 20060101 A61B034/10; A61B 90/00 20060101
A61B090/00 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 5, 2014 |
AU |
2014100879 |
Aug 5, 2014 |
AU |
2014100880 |
Aug 5, 2014 |
AU |
2014903035 |
Claims
1. A surgical access retractor for maintaining an enlarged surgical
corridor, said retractor having a length sufficient to span from a
skin surface through to a region of surgical interest, said
retractor having at least one portion shaped to match with the
region of surgical interest, wherein the shape of said portion is,
at least in part, based on patient specific medical imaging.
2. A surgical access retractor according to claim 1, wherein the
length sufficient to span from a skin surface through to a region
of surgical interest is determined by patient specific medical
imaging.
3. A surgical access retractor according to claim 1, wherein the
region of surgical interest is an anatomical body, such as a
vertebral body.
4. A surgical access retractor according to claim 1, wherein the
region of surgical interest is a pedicle.
5. A surgical access retractor according to claim 1, wherein the
shaped portion of the retractor comprises one or more fixation
means for securing the retractor to the region of surgical
interest.
6. A surgical access retractor according to claim 1, wherein the
retractor comprises a lip on the top face which, in use, is placed
on patient's skin.
7. A surgical access retractor according to claim 1, wherein the
retractor comprises at least one fixation means for securing the
retractor to a patient's skin.
8. A surgical access retractor according to claim 6, wherein the
angle of the lip is customised based on patient medical
imaging.
9. (canceled)
10. (canceled)
11. (canceled)
12. A surgical access retractor according to claim 1, wherein the
retractor comprises antimicrobial substances or surface coatings to
reduce the risk of infection.
13. A surgical access retractor according to claim 1, wherein the
retractor comprises radio-opaque markers to allow verification of
positioning by way of image intensification.
14. (canceled)
15. A surgical access retractor according to claim 1, wherein, in
use, electrophysiological sensors are placed beside the access
retractor in preset locations to facilitate neural monitoring in
the working area.
16. A surgical access retractor according to claim 1, wherein the
retractor comprises ancillary channels to allow suction of fluid
from an internal aperture of the device or irrigation of fluid into
an internal aperture of the device.
17. A method for designing a patient specific access retractor
comprising the steps of: a) determining one or more trajectories
from a region of surgical interest to the skin surface of a patient
using preoperative medical imaging; b) determining the morphology
of the region of surgical interest using preoperative medical
imaging; and c) designing the access retractor, said retractor
having a length sufficient to span from a skin surface through to
the region of surgical interest, said retractor having at least one
portion shaped to dock with the region of surgical interest,
wherein the shape of said portion is based, at least in part, on
patient specific medical imaging.
18. A method for manufacturing a patient specific access retractor
comprising the steps of: a) determining one or more trajectories
from a region of surgical interest to the skin surface of a patient
using preoperative medical imaging; b) determining the morphology
of the region of surgical interest using preoperative medical
imaging; c) designing the access retractor, said retractor having a
length sufficient to span from a skin surface through to the region
of surgical interest, said retractor having at least one portion
shaped to dock with the region of surgical interest, wherein the
shape of said portion is based, at least in part, on patient
specific medical imaging; and d) manufacturing the access
retractor.
19. A method according to claim 17, wherein the region of surgical
interest is an anatomical body, such as a vertebral body.
20. A method according to claim 19, wherein the vertebral body is a
pedicle.
21-30. (canceled)
31. A method for accessing a region of surgical interested
comprising the steps of: a) providing a retractor according to
claim 1; b) docking the shaped portion of the retractor via a
surgical corridor to the region of surgical interest; and c) fixing
said retractor to the region of surgical interest.
32. A method according to claim 31, wherein prior to docking the
shaped portion of the retractor to the region of surgical interest
one or more dilators are utilized to increase the width of the
surgical corridor.
Description
FIELD
[0001] The present disclosure relates generally to a surgical
access retractor. More specifically, the disclosure is directed to
a minimally invasive surgical access retractor and a method of
minimally invasive retraction that expands the field of
operation.
BACKGROUND
[0002] In recent years, minimally invasive surgical (MIS)
approaches have been applied to orthopaedic surgery and more
recently to spine surgery, such as instrumented fusions involving
one or more vertebral bodies.
[0003] The evolution of MIS surgery has been dependent on the
development of new technologies. Such technologies include
prosthetic devices such as screws and rods and interbody fusion
cages and access retractors, to allow the surgeon to perform
placement of such devices via small incisions and openings in the
patient's body.
[0004] In regard to the lumbar spine, minimally invasive surgical
technique may be applied to the operation of transforaminal lumbar
interbody fusion (TLIF). A minimally invasive transforaminal lumbar
interbody fusion may be performed by four small 2 cm incisions in
the lumbar region. The incisions are used to place pedicle screws
and one of the incisions is used to place a retractor system so
that the surgeon can see the anatomical elements such as the nerve
roots and the intervertebral disc. The surgeon uses a retractor to
perform laminectomy to decompress the associated exiting nerve
roots, perform lumbar discectomy and prepare the interbody space
and then place bone graft and an interbody cage to facilitate
interbody fusion. The MIS TLIF has evolved to a stage where a
surgery can be performed in a highly repeatable fashion with a high
degree of safety and reliability of outcome.
[0005] Minimally invasive surgical procedures may involve the use
of a series of muscle dilators that separate the muscle fibers of
the spine to create a pathway to the spine. A Kirschner wire
(K-wire) is initially introduced through a small incision and
directed towards the spinal pathology. The position of the K-wire
may be visualized by a fluoroscopic imaging system to identify its
location. An initial narrow diameter muscle dilator is passed over
the K-wire, and the K-wire is removed and subsequent larger muscle
dilators are continually passed. When the opening is large enough,
an access tube or retractor is positioned around the last muscle
dilator through which the surgery is performed. The inner
sequential muscle dilators are then removed allowing the surgeon to
operate through the tubular retractor
[0006] Furthermore a surgical device company will commonly provide
a retractor set for surgery, and such a retractor set often
requires multiple retractors of varying diameters and lengths as
well as attachment ends to the operating table. As standard surgery
requires many instruments and devices to perform the surgery, it
incurs a substantial logistic cost. This involves: [0007] cleaning,
sterilisation and processing of all components prior to each
procedure; [0008] delivery and transfer of components from the
device company warehouse to and from the hospital is time consuming
and expensive; [0009] such stock must be replaced and accounted for
and can be difficult to track and validate.
[0010] Therefore, a continuing need exists for an improved device,
an improved system, and an improved method for performing surgery,
particularly minimally invasive spinal surgery.
[0011] The reference in this specification to any prior publication
(or information derived from it), or to any matter which is known,
is not, and should not be taken as an acknowledgement or admission
or any form of suggestion that that prior publication (or
information derived from it) or known matter forms part of the
common general knowledge in the field of endeavour to which this
specification relates.
SUMMARY
[0012] In one aspect there is provided a surgical access retractor
for maintaining an enlarged surgical corridor, said retractor
having a length sufficient to span from a skin surface through to a
region of surgical interest, said retractor having at least a
portion thereof shaped to match with the region of surgical
interest, wherein the shaped portion is, at least partly, based on
patient specific medical imaging.
[0013] The region of surgical interest may be a vertebral body. The
region of surgical interest may be a pedicle.
[0014] The access retractor may be patient specific through
matching the shaped portion to the morphology of the region of
surgical interest. As the retractor may dock on patient anatomy in
a specific way, fixation of the retractor to the anatomy may be
facilitated. Fixation of the retractor to the patient anatomy may
provide surgical access in an accurate, reliable and safe fashion.
The specific retractor may be used as a guide to perform, for
example, osteotomy and in the placement of, for example,
intervertebral prosthesis and bone graft.
[0015] Advantageously, the patient specific access retractor
obviates the need to have retractors of various sizes available at
the time of surgery. This substantially reduces the logistics and
cost of preparation of instruments for surgery.
[0016] The access retractor may be patient specific and procedure
specific.
[0017] The shaped portion of the retractor may comprise one or more
apertures or fixation means for securing the retractor to the
region of surgical interest.
[0018] The retractor may comprise a lip on the top face which, in
use, is placed externally on a patient's skin.
[0019] The angle of the lip may be customised based on patient
specific medical imaging.
[0020] The lip may comprise at least one aperture or fixation means
for securing the retractor to a patient's skin.
[0021] Fixation of the retractor both at the region of surgical
interest and at the patient's skin is advantageous as it obviates
the need for extraneous attachment, such as via an arm to a
surgical table.
[0022] As the retractor is patient specific, various features may
be included in the retractor design which are also patient
specific. The placement of features in the retractor may be enabled
through patient imaging and computer aided design. The features may
be, at least partly, located in the shaped portion of the access
retractor.
[0023] Specific grooves or channels may be incorporated into the
retractor to conform with the contour of the retractor and/or
conform with patient specific anatomy, in such a way as to mark,
localise or perform predetermined surgical intervention. In this
way, the access retractor may be used to guide instruments; for
example to perform osteotomy, monitor neural function, guide
instruments to perform intervertebral disc clearance and
preparation or to guide, place and deliver an intervertebral cage
prosthesis in an accurate manner.
[0024] The shaped portion may comprise one or more guides for
cutting bone. The guides may be positioned in the retractor based
on preoperative medical imaging.
[0025] These features are selected and predesigned into the
retractor so that the surgeon may accurately perform
procedures.
[0026] The retractor may be designed by using a combination of
computer aided design software and patient morphological data
obtained by medical imaging. For example, vectors may be determined
to run along the centre of pedicles of the spine. In this way the
intersection of the vector with the surface of the patient's skin
may be precisely determined. Further, the length of the vector from
the surface of the skin to the intersection with a particular
region of surgical interest, such as a bone interface, may be
determined.
[0027] Through the characterisation of the vector, computer design
software may be used to create patient specific dilators to allow
progressive dilation of a patient's tissue to a predetermined depth
and circumference around the vector replicated by, for example, a
wire, such that the patient specific access retractor can be
implanted into the patient.
[0028] The patient specific access retractor may incorporate a
predesignated vector so that it may be guided by way of a K-wire to
allow precise placement of the access retractor onto the anatomy to
be localized, such as the spine. The point of contact of the
retractor with both the skin surface, and the anatomy to be
localised at the base of the retractor may be contoured in a
patient specific manner using computer aided design software.
[0029] Once the patient specific shape of the retractor is
determined, the retractor may be manufactured using
three-dimensional printing.
[0030] One or more fixation points corresponding to the
intersection of the vector with the selected anatomy may be
incorporated into the retractor. The fixation may be by way of a
cannulated screw which is guided down a K-wire and inserted into
the patient's bone in such a way that the retractor is then secured
to the bone. It will be appreciated that a cannulated screw is one
method of securing the retractor. Other methods may include staples
or pins.
[0031] The patient specific retractor may also incorporate
ancillary channels to allow suction of fluid from the internal
aperture of the device or irrigation of fluid into the internal
aperture of the device.
[0032] Dilators may be used to assist in placement of the access
retractor and may incorporate components that allow electrocautery
by way of diathermy to be used at the tip of the dilator where the
interface of tissue and bone occurs. Such dilators may also include
components that allow neurophysiological monitoring of the
surrounding tissue and associated structures. The dilators may also
contain channels to allow irrigation and suction to occur.
[0033] The patient specific retractor may also incorporate
components to allow diathermy and cauterisation of surrounding
tissue.
[0034] The patient specific retractor may be impregnated with
antimicrobial substances or surface coatings to reduce the risk of
infection.
[0035] The patient specific retractor may incorporate radio-opaque
markers to allow verification of positioning by way of image
intensification. Preferably this would not be to the extent that
they would obscure patient anatomy.
[0036] The patient specific retractor may facilitate localisation
to other areas of anatomy, for example to harvest bone graft
without instruments or for reconstructing donor site anatomy.
[0037] The access retractor may also incorporate components to
allow electrophysiological monitoring of surrounding structures and
tissue.
[0038] Furthermore a guide or groove within the retractor may be
used to facilitate suction or aspiration of fluid and gas from the
working area.
[0039] Furthermore an access aperture or groove may be used to
facilitate irrigation of fluid into the working area.
[0040] Electrophysiological sensors may be placed beside the access
retractor in pre-set locations to facilitate neural monitoring in
the working area.
[0041] The retractor may comprise any combination of the
hereinbefore disclosed embodiments.
[0042] In another aspect there is provided a method for designing a
patient specific access retractor comprising the steps of: [0043]
a) determining one or more trajectories from a region of surgical
interest to the skin surface of a patient using preoperative
medical imaging; [0044] b) determining the morphology of the region
of surgical interest using preoperative medical imaging; and [0045]
c) designing an access retractor, said retractor having a length
sufficient to span from a skin surface through to the region of
surgical interest, said retractor having at least one portion
shaped to dock with the region of surgical interest, wherein the
shape of said portion is based, at least in part, on patient
specific medical imaging.
[0046] In another aspect there is provided a method for
manufacturing a patient specific access retractor comprising the
steps of: [0047] a) determining one or more trajectories from a
region of surgical interest to the skin surface of a patient using
preoperative medical imaging; [0048] b) determining the morphology
of the region of surgical interest using preoperative medical
imaging; [0049] c) designing an access retractor, said retractor
having a length sufficient to span from a skin surface through to
the region of surgical interest, said retractor having at least one
portion shaped to dock with the region of surgical interest,
wherein the shape of said portion is based, at least in part, on
patient specific medical imaging; and [0050] d) manufacturing the
access retractor.
[0051] In any of the hereinbefore disclosed embodiments the region
of surgical interest may be an anatomical body.
[0052] In any of the hereinbefore disclosed embodiments the
anatomical body may be a vertebral body. The vertebral body may be
a pedicle.
[0053] In any of the hereinbefore disclose embodiments the medical
imaging may be computed tomography.
[0054] In any of the hereinbefore disclosed embodiments the access
retractor may be manufactured using rapid prototype technology.
[0055] In any of the hereinbefore disclosed embodiments the access
retractor may be manufactured using three-dimensional printing.
[0056] In any of the hereinbefore disclosed embodiments the
trajectories may be represented as three-dimensional images with
the aid of suitable computer software. The trajectories may be
determined to meet the skin at particular entry points.
[0057] The access retractor may be manufactured from a suitable
compatible polymer, such as, for example, polyether ether
ketone.
[0058] In another aspect there is provided a use of an access
retractor as hereinbefore disclosed in a surgical procedure. The
surgical procedure may be spinal surgery. The surgical procedure
may be minimally invasive spinal surgery. The surgical procedure
may be spinal fusion. The surgical procedure may be transforaminal
lumbar interbody fusion (TLIF).
[0059] In another aspect there is provided a method for accessing a
region of surgical interested comprising the steps of: [0060] a)
providing a retractor according to any one of the hereinbefore
disclosed embodiments; [0061] b) docking at least part of the
shaped portion of the retractor via a surgical corridor to the
region of surgical interest; and [0062] c) fixing said retractor to
the region of surgical interest.
[0063] The retractor may also be fixed to the skin of the patient
via a suitable fixation method. For example via an aperture in the
lip of the retractor.
[0064] Throughout this specification, use of the terms "comprises"
or "comprising" or grammatical variations thereon shall be taken to
specify the presence of stated features, integers, steps or
components but does not preclude the presence or addition of one or
more other features, integers, steps, components or groups thereof
not specifically mentioned.
BRIEF DESCRIPTION OF THE DRAWINGS
[0065] FIG. 1(a) is a plan view of an access retractor according to
an embodiment of the present disclosure.
[0066] FIG. 1(b) is a plan view of an access retractor according to
an embodiment of the present disclosure.
[0067] FIG. 1(c) shows a cutaway of an access retractor according
to an embodiment of the present disclosure.
[0068] FIG. 1(d) is a side elevation of an access retractor
according to an embodiment of the present disclosure.
[0069] FIG. 1(e) shows a section through plane A-A of the access
retractor of FIG. 1(a) according to an embodiment of the present
disclosure.
[0070] FIG. 1(e) shows a side elevation of an access retractor
according to an embodiment of the present disclosure.
[0071] FIGS. 2 to 5 show a computer designed access retractor in
use according to an embodiment of the present disclosure.
[0072] FIG. 6 is an enlargement of FIG. 1(c).
DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0073] Before the present devices and/or methods are disclosed and
described, it is to be understood that unless otherwise indicated
this disclosure is not limited to specific devices, components,
designs, methods, or the like, as such may vary, unless otherwise
specified. It is also to be understood that the terminology used
herein is for the purpose of describing particular embodiments only
and is not intended to be limiting.
[0074] It must also be noted that, as used in the specification and
the appended claims, the singular forms `a`, `an` and `the` include
plural referents unless otherwise specified. Thus, for example,
reference to `a guide wire` may include more than one guide wires,
and the like.
[0075] Disclosed herein are advantageous devices and methods for
performing surgery, particularly spinal fusion surgery.
[0076] In an exemplary embodiment a patient specific access
retractor is provided. Once the depth of tissue to be accessed by
the retractor is known from patient medical imaging, standard
design may be applied to the external or top part of the retractor.
This may extend to approximately 80% of the depth of the access
retractor. The final approximately 20% may be designed in a
specific way to contour match the morphology of the patient's
anatomy and in particular, the region of surgical interest.
[0077] A guidance aperture may be within the retractor where a
Nitinol K-wire is used to localise the retractor to the patient
specific anatomy. The guidance aperture may also allow placement of
a cannulated screw to secure the retractor to the patient's spine.
Within the guidance aperture may be specially designed grooves,
which facilitate placement of instruments in locations within the
working area of the access retractor. Such grooves may be used to
place mark-to-mark osteotomy lines on the patient's bone and then
guide instruments into the interbody space. The access retractor
may also comprise an attachment for a Nitinol K-wire on the
rosteral side of the intervertebral disc to be operated on. This
facilitates attachment of the access retractor to the patient. The
access retractor may have apertures or instrument guides such that
a fibre optic light source may be attached. The access retractor
may have a guide or facility for the use of diathermy at the base
of the retractor. The customised portion of the retractor may have
diathermy points or a guide for the use of such points in the
equipment such that the tissue can be cauterised.
[0078] In order to evolve the manufacturing procedure to a greater
level of ergonomic efficiency, safety and best possible patient
outcomes, three-dimensional printing technology has been used to
facilitate these outcomes.
[0079] Three-dimensional printing is a process whereby layer based
polymerisation of a resin or powder is used to produce a solid
object. This technology has been applied to producing solid
replicas of anatomy which has been captured by medical imaging.
[0080] Three-dimensional printing technology has been used
extensively in computerised design product development prototyping
and more recently direct manufacturing of objects. It has been
possible to integrate computer design and anatomical biomodeling
information to provide customised prosthetic implants for the human
body. This disclosure uses rapid prototyping technology to
facilitate interbody fusion by way of the minimally invasive
transforaminal interbody fusion technique. Three-dimensional bench
top printing has been integrated with diagnostic surgical planning,
surgical navigation and by way of patient specific minimally
invasive access retractors.
[0081] The patient specific access retractor may also be used for
harvesting bone graft. A second retractor may be manufactured by
three-dimensional printing to dock on the iliac crest or other part
of the skeleton to harvest bone graft. In this embodiment, a vector
is created from either the right or left iliac crest which crosses
the skin at the same point, if possible, as one of the vectors
identifying the pedicle of the selected vertebra. Alternatively, a
vector exiting at a separate point would be another option. The
depth of tissue from the surface to the iliac crest or bone donor
site is determined. The retractor is again contour matched to the
surface of the iliac crest or bone donor site and the length and
diameter of the retractor is then constructed in three-dimensional
design software. The retractor incorporates a guide for placement
along a K-wire that has been fixed to the iliac crest bone donor
site. The retractor is then manufactured by way of
three-dimensional printing in a bio-compatible material. At the
time of surgery, the surgeon places a Jamshidi needle into the
iliac crest or suitable bone donor site and places a K-wire. The
K-wire is then used to guide the retractor to the iliac crest or
bone donor site and a cannulated screw is then used to secure the
retractor to the crest. The retractor may act to guide instruments
to harvest bone graft by way of specific channels and grooves
within the retractor.
[0082] Referring to FIG. 1(a), access retractor (1) is illustrated.
The retractor has a fixation point (2), located on the shaped
portion of the retractor, for fixing to an anatomical body and
guides (3) to facilitate, for example, the introduction of
instruments. An aperture (4) on the retractor lip is available to
secure the retractor to the patient's skin.
[0083] Referring to FIG. 1(b), a guide (3) for instrument
introduction is highlighted.
[0084] Referring to FIGS. 1(c) and 6, the portion (5) of retractor
(1) is shaped based on patient specific information so as to dock
with a region of surgical interest.
[0085] Referring to FIG. 1(d), lip (6) is angled based on patient
specific medical imaging.
[0086] FIG. 1(e) depicts a section A-A through retractor (1) of
FIG. 1(a). The section shows fixation point (2) and other shaped
structure (7).
[0087] FIG. 1(f) indicates the length of the retractor to be 60 mm,
that is, the length from the region of surgical interest to the
surface of the skin.
[0088] FIGS. 2 to 5 illustrate various computer simulations of
retractor (1) fixed in place on vertebral body (8). FIG. 3 shows a
cutaway of the tissue surrounding the vertebral body with retractor
(1) fixed in place. FIG. 4 is similar to FIG. 3 but the tissue (9)
is now illustrated with the lip (6) of the retractor is located
external to the tissue structure. FIG. 5 shows retractor (1) fixed
in place on a vertebral body (8) with the shaped portion (5)
docking with the vertebral body.
[0089] While the foregoing description has focused on spinal
surgery, it is contemplated that the retractors and methods
described herein may find use in a wide range of surgical
applications. Thus, where it is desired to insert a screw or pin
into bone in a minimally invasive manner, or otherwise to access a
surgical target site via an instrument, the retractors and dilators
of the present disclosure may be used.
[0090] It is to be understood that while the present disclosure has
been described in conjunction with the specific embodiments
thereof, the foregoing description is intended to illustrate and
not limit the scope of the disclosure. Other aspects, advantages
and modifications will be apparent to those skilled in the art to
which the disclosure pertains. Therefore, the above examples are
put forth so as to provide those skilled in the art with a complete
disclosure and description of how to make and use the disclosed
devices, and are not intended to limit the scope of the
disclosure.
[0091] For the sake of brevity, only certain ranges are explicitly
disclosed herein. However, ranges from any lower limit may be
combined with any upper limit to recite a range not explicitly
recited, as well as, ranges from any lower limit may be combined
with any other lower limit to recite a range not explicitly
recited, in the same way, ranges from any upper limit may be
combined with any other upper limit to recite a range not
explicitly recited.
[0092] All documents cited are herein fully incorporated by
reference for all jurisdictions in which such incorporation is
permitted and to the extent such disclosure is consistent with the
description of the present disclosure.
* * * * *