U.S. patent application number 13/248928 was filed with the patent office on 2012-08-16 for minimally obstructive retractor.
This patent application is currently assigned to Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California. Invention is credited to Sudeep Deshpande, Ricardo Hahn, Kelly Jones, Afshin Nadershahi, Carrie Nichols.
Application Number | 20120209076 13/248928 |
Document ID | / |
Family ID | 45890378 |
Filed Date | 2012-08-16 |
United States Patent
Application |
20120209076 |
Kind Code |
A2 |
Hahn; Ricardo ; et
al. |
August 16, 2012 |
MINIMALLY OBSTRUCTIVE RETRACTOR
Abstract
This application presents minimally-obstructive and
structurally-adjustable retractors which afford an open work area
of desirable size and enhanced visualization for a surgeon about
the perineum and the posterior vaginal wall of the patient. The
retractors may be lightweight and compact, and also configured and
dimensioned to minimize slippage during use. The retractors may
retract the engorged labia of the postpartum patient as well as the
vaginal walls. The device may also be used as a speculum.
Inventors: |
Hahn; Ricardo; (Ojai,
CA) ; Nadershahi; Afshin; (Northridge, CA) ;
Nichols; Carrie; (Newport Beach, CA) ; Jones;
Kelly; (Norwalk, CA) ; Deshpande; Sudeep; (Los
Angeles, CA) |
Assignee: |
Alfred E. Mann Institute for
Biomedical Engineering at the University of Southern
California
Los Angeles
CA
90089-1112
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20120083658 A1 |
April 5, 2012 |
|
|
Family ID: |
45890378 |
Appl. No.: |
13/248928 |
Filed: |
September 29, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61/387863 |
Sep 29, 2010 |
|
|
|
61/436119 |
Jan 25, 2011 |
|
|
|
Current U.S.
Class: |
600/205 ;
600/201; 600/226; 600/231; 600/245 |
Current CPC
Class: |
A61B 2017/00407
20130101; A61B 17/0218 20130101; A61B 2017/00849 20130101; A61B
1/32 20130101; A61B 17/42 20130101; A61B 2090/309 20160201 |
Class at
Publication: |
600/205 ;
600/201; 600/231; 600/226; 600/245 |
International
Class: |
A61B 1/32 20060101
A61B001/32 |
Claims
1. A minimally obstructive retractor having a proximal end and a
distal end, and an exterior surface and an interior surface
comprising: a central body portion, at least two wings, and at
least two hinges, each configured to affix a different one of the
at least two wings to the central body portion; wherein the central
body portion, the at least two wings, and the at least two hinges
form a canopy such that the fluid flow through the exterior surface
of the canopy, defined by the exterior surfaces of the body, wings
and hinges, is substantially blocked.
2. The minimally obstructive retractor of claim 1, wherein the at
least two hinges are living hinges.
3. The minimally obstructive retractor of claim 1, further
comprising thinned portions, protrusions, or combinations thereof,
on the exterior surface of the central body portion, the wing, or
both the central body portion and the wing.
4. The minimally obstructive retractor of claim 1, further
comprising a ratchet mechanism.
5. The minimally obstructive retractor of claim 4, wherein the
ratchet mechanism comprises at least one arm that is affixed to the
interior surface of at least one wing.
6. The minimally obstructive retractor of claim 1, further
comprising a gripping proximal tip at the proximal end.
7. The minimally obstructive retractor of claim 1, further
comprising a retractor limiter at the proximal end.
8. The minimally obstructive retractor of claim 1, further
comprising an illumination source comprising at least one
light-emitting diode.
9. The minimally obstructive retractor of claim 8, wherein the at
least one light-emitting diode is located within the canopy.
10. The minimally obstructive retractor of claim 1, further
comprising an illumination source, wherein the illumination source
is located within the canopy.
11. The minimally obstructive retractor of claim 8, wherein the
illumination source is automatically turned on in conjunction with
movement of the ratchet arms away from each other and/or
automatically turned off in conjunction with movement of the
ratchet arms towards each other.
12. The minimally obstructive retractor of claim 1, wherein the
hinge comprises polyethylene, polypropylene, nylon, acetal plastics
or a mixture thereof.
13. The minimally obstructive retractor of claim 1, wherein the
hinge comprises polyethylene, polypropylene, or a mixture
thereof.
14. The minimally obstructive retractor of claim 1, the retractor
further comprises a lubrication source comprising a
lubricant-containing reservoir integrated to the retractor and
configured to provide lubricant to an outer surface of the
retractor.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is related, and claims priority, to U.S.
Provisional Patent Application Ser. No. 61/387,863, filed Sep. 29,
2010, entitled "Minimally Obstructive Surgical Retractor and
Speculum"; and U.S. Provisional Patent Application Ser. No.
61/436,119, filed Jan. 25, 2011, entitled "Minimally Obstructive
Retractor;" the entire contents of both of which are incorporated
herein by reference.
TECHNICAL FIELD
[0002] This invention relates generally to medical surgical
instruments, particularly structurally-adjustable retractors and
speculums for gynecological examinations and operations.
BACKGROUND
[0003] Devices which have been proposed for the purpose of vaginal
examination and gynecological surgical procedures may not be
entirely satisfactory for a variety of reasons. In many cases, they
may obstruct the vision of the deep internal parts of the vaginal
cavity that they are intended to expose. They may also constrain
the movement of the physicians' hands and reduce the open work area
for the surgeon. This often reduces the efficiency and
effectiveness of vaginal examinations and surgical procedures.
[0004] Furthermore, typically the vagina walls, the perineum (which
is the area of tissue between the vagina and the anus), and the
anus are torn during vaginal delivery. Natural perineal tears are
classified by their severity. First-degree tears involve tearing
only the skin. Second-degree tears involve tearing muscle.
Third-degree tears involve tearing the external anal sphincter
muscle. Fourth-degree tears further involve tearing the rectal
mucosa. When fourth-degree tears occur, the mother may require
post-birth surgery to stitch up the torn tissue, often under
general anesthetic.
[0005] Sometimes the perineum is purposely cut by a doctor
performing an episiotomy, which is an incision into the perineum to
enlarge the size of the vaginal opening. An episiotomy is similar
to a first or second-degree natural tear.
[0006] All of the above tearing or incisions usually require
post-delivery operations to stitch up the area. Stitching
fourth-degree tears is particularly difficult using known specula
given that fourth-degree tears typically extend from the vagina
wall all the way to the rectum. Such surgery is extremely difficult
due to the flaccid nature of the surrounding tissue which exists
immediately after birth.
[0007] Episiotomy retractors for retracting friable postpartum
vaginal tissue to facilitate repair of the episiotomy or vaginal
laceration are known. The primary function of the retractor is to
provide an open work area for the surgeon about the perineum and
posterior vaginal wall of the patient so that the surgeon can
conveniently and safely approximate and suture the tissue planes to
complete repair.
[0008] The known episiotomy retractors may not be entirely
satisfactory in use. Existing speculums may not permit access to
the area in which the stitching is required and furthermore may
tend to interfere with the surgeons ability to make the stitches in
the first place.
[0009] Most importantly, conventional retractors may fail to
provide sufficient open work area for the surgeon about the
perineum and the posterior vaginal wall of the patient. During the
delivery process the labia of the patient may become engorged with
blood and thus may tends to interfere with visualization of the
desired work area by the surgeon.
[0010] Furthermore, conventional retractors often include scissor
arms or other elongated portions for gripping and leverage.
However, these elements may increase the size and cost of the
devices, and can constrain the movement of the physicians' hands
and reduce the open work area for the surgeon.
SUMMARY
[0011] This application presents minimally obstructive retractors
and speculums that afford an open work area of desirable size and
enhanced visualization to users about the perineum and the
posterior vaginal wall of the patient. The retractor may be
lightweight, and configured and dimensioned to minimize slippage
during use. The position of various elements of the device may be
adjusted prior to, during, and after the procedure. The device may
retract the engorged labia of the postpartum patient as well as the
vaginal walls. The retractor may be simple and inexpensive to
manufacture, use and maintain.
[0012] The device may provide several benefits, including but not
limited to: permitting two-handed surgical techniques, facilitating
approximation of tissue layers, retaining its angle of retraction,
preventing fluids and tissues from obstructing the posterior
vaginal wall and perineum, and promoting hemostasis.
[0013] The device may be used for improved visualization, access,
and repair in various procedures, including, but not limited to:
obstetrical/gynecological procedures: vaginal inspection; perineal
inspection; vaginal wound repair; perineal wound repair; episiotomy
repair; female pelvic exam; pap smear; cervical biopsy;
vaginal/pelvic reconstruction; urological procedures; colorectal,
general, or other surgery; the device may be turned upside-down,
for example, for female urologic procedures; access to the cervix
(or uterus via cervix); IUD insertion, removal, or adjustment; and
dilatation & curettage (dilatation of cervix and curettage of
uterus).
[0014] The minimally obstructive retractor has a proximal end and a
distal end, and an exterior surface and an interior surface. In one
embodiment, this retractor may comprise a central body portion, at
least two wings, and at least two hinges, each configured to affix
a different one of the at least two wings to the central body
portion. The central body portion, the at least two wings, and the
at least two hinges form a canopy.
[0015] In another embodiment, this canopy is formed such that the
fluid flow through the exterior surface of the canopy, defined by
the exterior surfaces of the body, wings and hinges, is
substantially blocked. In an example of this embodiment, the hinges
may be living hinges.
[0016] The minimally obstructive retractor may further comprise
protruded portions, thinned portions, or combinations thereof. Such
protruded or thinned portions may be formed on the exterior surface
of the central body portion, the wing, or both the central body
portion and the wing.
[0017] The minimally obstructive retractor may also comprise a
ratchet mechanism. This ratchet mechanism may have one arm that is
affixed to the interior surface of at least one wing.
[0018] Furthermore, in one embodiment, the retractor may further
comprise a gripping proximal tip at the proximal end. Also, the
retractor may further comprise a retractor limiter at the proximal
end.
[0019] In some embodiments, the minimally obstructive retractor may
further comprise an illumination source. This illumination source
may comprise at least one light-emitting diode. In one embodiment,
the illumination source may be located within the canopy. In
another embodiment, the light emitting diode may be located within
the canopy. Yet, in another embodiment, the illumination source is
automatically turned on in conjunction with movement of the ratchet
arms away from each other and/or automatically turned off in
conjunction with movement of the ratchet arms towards each
other.
[0020] In other embodiments, the hinge may comprise polyethylene,
polypropylene, nylon, acetal plastics or a mixture thereof. The
hinge may also comprise polyethylene, polypropylene, or a mixture
thereof.
[0021] In an embodiment, the retractor may further comprise a
lubrication source comprising a lubricant-containing reservoir
integrated to the retractor and configured to provide lubricant to
an outer surface of the retractor.
[0022] It is understood that other embodiments of the devices and
methods will become readily apparent to those skilled in the art
from the following detailed description, wherein it is shown and
described only exemplary embodiments of the devices, methods and
systems by way of illustration. As will be realized, the devices,
systems and systems are capable of other and different embodiments
and its several details are capable of modification in various
other respects, all without departing from the spirit and scope of
the invention. Accordingly, the drawings and detailed description
are to be regarded as illustrative in nature and not as
restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Aspects of the minimally obstructive retractor are
illustrated by way of example, and not by way of limitation, in the
accompanying drawings.
[0024] FIG. 1 is an isometric view of an exemplary retractor.
[0025] FIG. 2 is a side view of the exemplary retractor of FIG.
1.
[0026] FIG. 3 is a bottom view of the exemplary retractor of FIG.
1.
[0027] FIG. 4 is a rear view of the exemplary retractor of FIG.
1.
[0028] FIG. 5 is an isometric view of another exemplary
retractor.
[0029] FIG. 6 is a side view of the exemplary retractor of FIG.
5.
[0030] FIG. 7 is a rear view of the exemplary retractor of FIG.
5.
[0031] FIG. 8 is an isometric view of the exemplary retractor of
FIG. 5 without a ratchet mechanism.
[0032] FIG. 9 is a retractor arm of the ratchet mechanism of the
exemplary ratchet system of FIG. 5.
[0033] FIG. 10 is another retractor arm of the ratchet mechanism of
FIG. 5.
[0034] FIG. 11 is an isometric view of separated parts of the
ratchet mechanism of the exemplary retractor of FIG. 5.
[0035] FIG. 12 is an isometric view of another exemplary retractor
comprising a light source.
[0036] FIG. 13 is a close-up view of a ratchet cap, including a
light source, of the exemplary retractor of FIG. 11.
[0037] FIG. 14 is an isometric view of an alternative exemplary
retractor.
[0038] FIG. 15 is an isometric view of separated parts of the
exemplary retractor of FIG. 14.
[0039] FIG. 16 is an exploded, isometric view of separated parts of
the exemplary retractor of FIG. 14.
[0040] FIG. 17 is an exploded, side view of separated parts of the
exemplary retractor of FIG. 14.
DETAILED DESCRIPTION
[0041] The detailed description set forth below in connection with
the appended drawings is intended as a description of exemplary
embodiments and is not intended to represent the only embodiments
in which the retractors and speculums can be practiced. The term
"exemplary" used throughout this description means "serving as an
example, instance, or illustration," and should not necessarily be
construed as preferred or advantageous over other embodiments. The
detailed description includes specific details for the purpose of
providing a thorough understanding of the retractors/speculums.
However, it will be apparent to those skilled in the art that the
retractors/speculums and may be practiced without these specific
details.
[0042] This invention relates generally to medical surgical
instruments, particularly structurally-adjustable retractors and
speculums for gynecological examinations and operations. These
medical devices are hereafter called "minimally obstructive
retractors" or "retractors."
[0043] The minimally obstructive retractor has a proximal end and a
distal end. This retractor may comprise a central body portion, at
least two wings, and at least one hinge configured to affix at
least one wing to the central body portion. The central body
portion, the at least one wing, and the at least one hinge may form
a canopy.
[0044] In some embodiments, the canopy may be formed such that the
fluid flow through the exterior surface of the canopy, defined by
the exterior surfaces of the body, wings and hinges, is
substantially blocked. An example of this embodiment comprises a
so-called "living hinge". In this example, the retractor may be
formed as one piece, by using manufacturing techniques such as
molding, machining or welding. And the thinned section of the
retractor, which is relatively thinner than the central body
portion and the wings, forms the living hinge. Thereby, the
one-piece retractor can easily flex along the line of the living
hinge. A hinge of this type may be capable of many flexures over an
extended period of time without the material fatiguing or
breaking.
[0045] In one embodiment, the width of the living hinge is smaller
than the width of the wing and/or the central body portion. In
another embodiment, the living hinge width is substantially smaller
than the width of the wing and/or the central body portion.
[0046] The living hinge is not the only retractor example that has
a canopy wherein the fluid flow through the exterior surface of the
canopy is substantially blocked. Other examples are as follows. In
one example, a retractor may be formed by substantially reducing
the width of the hinge and/or the width of the gap between the
central body portion and the wing. In another example, the wings
are formed to overlap on the exterior surface of the central body
portion or the central body portion is formed to overlap on the
exterior surface of the wings. Yet, in another example, the
retractor may further comprise a substantially impermeable membrane
that substantially covers the exterior and/or the interior surface
of the canopy, or the exterior and/or the interior surface of the
gap between the central body portion and the wings.
[0047] The wing has a proximal end and a distal end. The wing also
has a top adjacent to the hinge and a bottom.
[0048] FIGS. 1-4 depict various views of an exemplary minimally
obstructive retractor (100). The exemplary device (100) comprises
wings (102, 103). These wings may be solid. These wings may also be
hollow and shell-like to provide a convex exterior and conversely,
a generally concave interior to permit visual as well as manual
access thereto. The wings may be of a shape, contour, thickness,
angle, radius, and size to hold up the vaginal walls during various
procedures.
[0049] The wings (102, 103) may be affixed to a central body
portion (101). The central body portion (101) may be convex on the
exterior of the device (100) and concave on the interior. The
central body portion (101) may be of a shape, contour, thickness,
angle, radius, and size to hold up the vaginal walls during various
procedures.
[0050] The wings (102, 103) may be connected to the central body
portion (101) by hinges (104, 105). The hinges (104, 105) may
comprise the same or different material as the wings (102, 103) and
the central body portion (101). The hinges (104, 105) may permit
the wings (102, 103) to flex or pivot about the central body
portion (101) such that the lower longitudinal wing edges of the
retractor may be pivoted open to permit visual and manual access to
the interior of a body passage.
[0051] The wings (102, 103) may also comprise protruded and/or
thinned portions (120, 121) to provide friction and prevent the
device (100) from undesirable movement during use. These thinned
portions are thinner than the remaining portions of the wing. The
protruded and/or thinned portions (120, 121) may protrude from the
wings (102, 103) or be etched or carved into the wings. The
protruded and/or thinned portions may be anywhere on the wings. The
protruded and/or thinned portions may comprise various shapes or
forms such as grooves, serrations, cross-hatches, bumps, or other
morphologies to provide adequate friction with the tissue, while
not damaging the tissue or causing discomfort to the patient. In
other embodiments, the top portion of the central body portion
(101) may comprise grooves, blunted barbs, or other textures to
provide friction and to resist slippage of the device within the
vaginal cavity. In one exemplary embodiment, the wings comprise
serrated wing edges. This serrated wing edges may be at the
bottom.
[0052] The exemplary device (100) may also comprise a distal tip
(106), which is the first part of the device inserted into the
body. The distal tip (106) may be thick and wide enough to hold the
upper portion of the vaginal walls during various procedures. The
distal end of the distal tip (106) may be round and smooth to
provide comfort and minimize damage to the tissue during use. The
distal tip (106) may also comprise a concave portion (107) that
facilitates insertion into the body and provides better contact
with the tissue by conforming to the body structure. In some
embodiments, the distal tip (106) may also comprise grooves,
blunted barbs, or other textures to provide friction and to resist
slippage of the device within the vaginal cavity.
[0053] The exemplary device (100) may also comprise a ratchet
mechanism (108), as depicted in FIG. 4. This ratchet mechanism
(108) may serve to provide structural support to the wings (102,
103) to counteract the force of the vaginal walls on the wings.
This structural support may also prevent the hinges (104, 105) from
breaking due to the force of the vaginal walls on the wings (102,
103). The ratchet mechanism (108) may also serve to hold the wings
(102, 103) in various positions with respect to each other. For
example, the user may desire to have the wings (102, 103) closer to
each other during insertion and removal of the device (100).
Various wing positions may also be desired for different body
shapes, sizes, or morphologies.
[0054] The ratchet mechanism (108) may comprise ratchet arms (109,
110) that are affixed to the interior surfaces of the wings (102,
103). One ratchet arm (110) may comprise a peg (113) which may be
removably interlocked in different positions to various teeth (114)
on the other ratchet arm (109). In some embodiments, the ratchet
arms (109, 110) may be affixed directly to the wings (102, 103),
not shown, while in other embodiments the arms (109, 110) may be
affixed to bases (111, 112) that are affixed to the wings (102,
103), as shown in FIG. 4. The bases (111, 112) may provide
additional structural support to the wings (102, 103) and may
prevent the ratchet arms (109, 110) from breaking off of the wings
(102, 103). In some embodiments, the ratchet mechanism (108) may be
configured to prevent the wings (102, 103) from moving toward each
other from the force of the vaginal walls, while in other
embodiments the ratchet mechanism (108) may be configured to lock
together to prevent the wings (102, 103) from moving away from each
other (due to the configuration of the hinges).
[0055] In another exemplary embodiment (not shown), the device
(100) may comprise a gripping proximal tip at the proximal end.
This gripping proximal tip may extend from the proximal end of the
central body portion (101). This gripping proximal tip may stick
out of the vagina while the rest of the device is inserted, and
thus allow the user to grab the portion to facilitate removal of
the device from the body.
[0056] FIG. 5 presents an isometric view of another exemplary
retractor (100). In this embodiment, the retractor comprises a
retractor limiter (201). The limiter (201) may be included in the
same molded part as the central body portion (101). The limiter
(201), shown from the side in FIG. 6, may prevent the retractor
(100) from penetrating too far into vagina, and may prevent damage
to the cervix, uterus, or other parts of the female patient. The
limiter (201) may also have a smooth surface free of surface
protrusions or holes in order to prevent painful interaction with
the clitoris.
[0057] The wings (102, 103) of FIG. 5 also comprise lips (202, 203)
at their proximal ends. The lips (202, 203) along with the wings
(102, 103), central body portion (101), and limiter (201) may
prevent blood, tissue, or other materials from entering the area
where the suturing takes place. The lips (202, 203) may also help
to prevent the retractor from penetrating too deeply into the
vagina. The lips may also increase stability of the retractor, and
help to secure its position with respect to the vagina.
[0058] The retractor (100) of FIG. 5 may also comprise a ratchet
mechanism (220) comprising two ratchet arms (222, 223), shown
straight-on in FIG. 7. As shown in the assembled view of FIG. 5,
the ratchet arms (222, 223) may attach to three areas of the
retractor body: at the base of each wing lips (202, 203) and at the
ratchet hub (221). As shown in FIG. 8, the lips (202, 203) may
comprise fasteners (216, 215), which may comprise barbed pins, that
engage the fastener recesses (225, 226) of the ratchet arms.
[0059] The ratchet arms (222, 223) may further attach to the body
of the retractor by means of central ratchet hub fastener (230)
protruding from the left retractor arm (222), as shown in FIG. 9.
The ratchet hub fastener (230) may comprise barbed pins. The
ratchet hub fastener pin (230) may pass through a hole (231) shown
in FIG. 10. The ratchet hub fastener pin (230) may also fasten to a
limiter recess (204) on the proximal side of the limiter (201),
shown in FIG. 8. The limiter recess (204) of FIG. 8 may be
elongated along its vertical axis in order to allow the fastener
pin (230) to slide up and down along the vertical axis of the
limiter. This sliding may be necessary as the ratchet arms (222,
223) move away from each other, since in this embodiment the
fasteners (216, 215) are fixed to the lips (202, 203).
[0060] In other embodiments, the limiter recess may not be
elongated, so that the fastener pin (230) would not move up or down
with respect to the limiter (201). Rather, the fastener recesses
(225, 226) of the ratchet arms could be elongated so that the
fasteners (216, 215) is fixed to the lips (202, 203) and could move
along the elongated fastener recesses (225, 226).
[0061] As shown in FIG. 5, FIG. 6, FIG. 7, and FIG. 11, the ratchet
arms (222, 223) may also comprise ratchet grasps (224, 225). The
ratchet grasps may be useful for spreading the ratchet arms away
from, or closer to, each other. The ratchet grasps may also be
useful for altering the position of the retractor (100), inserting
the retractor, or removing the retractor. The ratchet grasps (224,
225) may further comprise textures, or other protruded and/or
thinned portions, in order to increase friction and facilitate
gripping by the user.
[0062] FIGS. 9 and 10 show additional details of the ratchet
mechanism (220). FIG. 9 shows the left ratchet arm (222) turned
over to show its inner workings. The other ratchet arm (223), shown
in FIG. 10, comprises a ratchet release trigger (241) that
comprises a ratchet release trigger handle (243) and a ratchet
release tooth engager (242). The ratchet release tooth engager
(242) may be configured to latch onto the ratchet teeth (240) of
the ratchet arm (222) of FIG. 9. The tooth engager (242) may
release from the teeth (240) when the user presses the trigger
handle (243).
[0063] In FIG. 9, a carve-out to the right of the ratchet teeth
(241) may serve as a ratchet limiter engaging slot (246) along
which a ratchet limiter stop (245) of FIGS. 10 and 11 may move as
the ratchet arms move relative to each other. This may prevent the
distance between the bases of the of the ratchet arms (222, 223)
from exceeding three inches. In some embodiments, the distance may
be more than three inches, for instance four inches. In other
embodiments, it may be 2.5 inches or less.
[0064] In some embodiments, the retractor may comprise a polymer
such as acrylonitrile butadiene styrene (ABS), polyurethane, acetal
plastics, or another material known to those skilled in the art
that provides both structural rigidity and flexibility. It may
comprise flexible plastic material such as polyamide sold under the
trade name "NYLON," polytetrafluoroethylene sold under the
trademark "TEFLON". Alternatively, a polypropylene plastic or a
high density polyethylene plastic may be used to manufacture the
retractor. The device may be made of a transparent plastic in order
to enhance the viewing area. It may also be made of metal. Mixtures
or composites of these materials may also be used to manufacture
the minimally obstructive retractor.
[0065] The hinge may comprise a polymer. The hinge, for example,
may comprise polyethylene, polypropylene, nylon, acetal plastics or
mixtures thereof. In another example, the hinge material may even
be polyethylene, polypropylene or mixtures thereof.
[0066] The retractor may be sterilizable by ethylene oxide, gamma
radiation or other process known to those skilled in the art. It
may be disposable or reprocessable. Also, the device may be made of
different sizes and/or thicknesses to accommodate different ages
and sizes of patients. The device may be coated with a material to
facilitate inspection and movement. For example, a lubricant can be
used to coat the device to facilitate insertion and retrieval.
[0067] In one embodiment, the minimally obstructive retractor
further comprises an illumination source. The illumination source
may comprise more than one illumination devices.
[0068] Yet, in a further embodiment, one or all device components
forming the illumination source are located within the canopy
formed by the retractor. For example, the illumination source may
comprise a light-emitting diode wherein the light emitting diode is
located within the retractor canopy. Also, in another example, the
whole illumination source is located within the retractor canopy.
In such embodiments, a compact retractor with no illumination
source components dangling beyond the other retractor parts may be
obtained.
[0069] One exemplary embodiment of the minimally obstructive
retractor (100) comprising an illumination source (260) is shown in
FIG. 12. As shown in FIG. 13, an exemplary illumination source
(260) may comprise a light (262), such as battery-powered
light-emitting diode (LED), located within a light source housing
(261). In the embodiment of FIGS. 12 and 13, the light source
housing (261) may be attached to a cap (266) that attaches to the
limiter (201) of FIG. 12. The cap (266) may attach to the limiter
(201) by means of a fastener (263), comprising a pin (264), which
connects to either a ratchet arm or the limiter (201). In some
embodiments, the cap (266) does not have a fastener; rather it may
attach by means of an adhesive. In some embodiments, the
illumination housing (261) may be configured to swivel. In some
embodiments the user may manually operate the light function
externally via a mechanical switch, while in alternative
embodiments, the light function may be turned on and off
automatically.
[0070] FIGS. 14-17 depict various views of another exemplary
retractor with alternative illumination and structural features.
The device may comprise a central body portion (101), wings (102,
103) that may be connected to the central body portion (101) via
living hinges (104, 105), and a ratchet mechanism (108). The
ratchet arms (109, 110) may be assembled together at a ratchet hub
(221). For example, a ratchet hub fastener (230) on ratchet arm
(222) shown in FIG. 16 may fasten to a limiter recess (204) within
a limiter (201) shown in FIG. 15.
[0071] As shown in FIG. 15, to stabilize the sliding motion of the
main body relative to the ratchet arms, the central body portion
(101) may comprise two pegs (281,282) which are able to travel back
and forth within mating grooves (283, 284, respectively) integrated
within the ratchet arms (109, 110), thereby effectively restricting
rotation of the retractor (100) off axis.
[0072] As shown in FIGS. 16 and 17, the wings (102, 103) may flare
outward along a portion of their length. In particular, distance
between the opposing wings may be greater toward the end that is
deeper the body cavity, and may be narrower toward the opening of
the vaginal cavity. Consequently, pressure of the vaginal walls
upon the length of the device's blades may tend to hold the device
within the cavity, thereby preventing the device from sliding out
of the vagina.
[0073] The exemplary embodiment of FIGS. 14 to 17 comprises an
alternative embodiment of an illumination source (260). The
illumination source (260) may comprise a plurality of light
emitting components such as light emitting diodes (LEDs) (400)
capable of producing sufficient visible light to view the area of
interest, a power supply such as coin cell batteries (295) to drive
the LED (400), power management components such as resistors, and
reed sensor switch (294) to activate the LED (400). The LED (400),
resistors, reed switch (294) and power supply batteries (295) may
be assembled on a printed circuit board (299), also known as a
PCB.
[0074] The exemplary embodiment of FIGS. 14 to 17 further comprises
an illumination source that may be automatically turned on and off
in conjunction with movement of the ratchet arms away from, and
towards, each other, respectively.
[0075] In the exploded view of the device in FIG. 17, the LED may
be turned on and off via a reed sensor switch (294). The reed
sensor switch (294) may be turned on in the presence of a magnetic
field generated by a magnet (293), and may turn off in the absence
of the magnetic field generated by the magnet. The reed sensor
switch (294) may be sensitive to the position of the magnet (293).
The magnet (293) may be positioned within a magnet receptacle (292)
within the stem (290). The stem (290) may hold the magnet (293) and
provide the magnet with a path to actuate the LED assembly by
positioning the magnet (293) within close enough proximity to the
reed sensor switch (294) to activate the switch (294).
[0076] The stem may be assembled between the limiter (201) and the
ratchet arms (222, 223). Specifically, the stem (290) may travel
along a vertical path within a recess (204) of the limiter (201) as
it travels along with the ratchet arms (222, 223) when the ratchet
arms are opened and closed to open and close the device wings (102,
103). A stem pin (291) may pass through the hole (231) on ratchet
arm (223) and engage with the ratchet hub fastener pin (230) of
ratchet arm (222). This engagement between the stem pin (291) and
the ratchet hub fastener pin (230) may cause the stem (290) to
slide along the limiter recess (204) of the limiter (201).
[0077] The coin cell batteries (295) may be connected using contact
wires (296) or directly assembled onto the PCB (299).
Alternatively, the electronic components may be brought in contact
to complete the circuit without soldering and connected by
compression of the assembly packaging.
[0078] The LED assembly (290) may be placed onto a plurality of
mounting posts (297) on an LED cover (298), which may comprise a
translucent material, and assembled into mating features (not
shown) located on the underside of the central body portion
(101).
[0079] In FIG. 17, a gasket (301), made of rubber or other
materials, may be placed between the LED cover (298) and an inner
surface of the central body portion (101) to prevent or minimize
the ingress of fluids and dirt into the LED assembly (290). In
addition, in the case of leaking power supply batteries, the gasket
(301) may prevent chemicals from leaking outside the device,
thereby protecting the user. The gasket (301) may be held in place
by mating features in the main body surface, by adhesive, or by
other means.
[0080] The LED cover (298) and LED assembly (298) may also be mated
with the main body via other fastening mechanisms such as screws or
epoxy.
[0081] The stem may travel in a vertical path inside a slot (302)
located with the LED cover (298), thereby making the actuation
mechanism hidden from to the user.
[0082] In another embodiment (not shown), the mechanism of turning
the light on and off may comprise a mechanical push button switch.
The switch may be placed behind the ratchet arms at a location
where the arms interact with each other. When the ratchet arms are
opened outward and pass over each other, the switch may be
triggered, thus completing the electrical circuit and turning on
the light.
[0083] In another embodiment, the mechanical push button switch may
be placed between the ratchet arm surfaces where the mechanical
push switch button may by pressed in the off position when the
ratchet arms are closed, thus keeping the light function off. When
the ratchet arms are opened outwardly, this may release the switch,
thereby turning the switch to the on position, completing the
electrical circuit and turning the light function on.
[0084] Alternatively, the mechanical push button switch may be
accessible to the user to manually turn the light function on or
off. The switch may be located on the ratchet arm hub for easy
access.
[0085] In another embodiment, an optical sensor switch may be used
to activate the light function. The switch may be placed in the
main body or ratchet arm and between the surfaces thereby occluding
the sensor of the switch from ambient light. When the ratchet arms
pass over and expose the optical sensor, the switch turns the light
function on.
[0086] In another embodiment, a breakoff plastic feature may be
used to trigger a switch (or an incomplete circuit by a separated
wire connection) to turn on the light. In the closed position, one
of the ratchet arms may be connected to the switch via a plastic
feature or tab. When the ratchet arms are pulled outward to open
the wings, this plastic tab could break, consequently activating
the switch (or completing the connection between the separated
wire) to turn on the light. With this mechanism, the device light
function could stay on until the batteries are drained of their
power. A variation of this mechanism may use the plastic tab as a
cover over the optical sensor switch. On pulling the ratchet arms
outwardly, the plastic tab could break and expose the optical
sensor, thereby completing the electrical circuit and turning the
light on.
[0087] In other embodiments, the device may comprise a plurality of
LEDs located at various portions of the interior of the device. For
example, the LEDs may be located on or integrated within the
interior surfaces of the central body portion (101), the distal tip
(106), and/or the wings (102, 103).
[0088] In some exemplary embodiments, the retractor may comprise a
lubrication source. This lubrication source may comprise a
lubricant-containing reservoir integrated with the body of the
device, and a channel for delivering the biocompatible lubricant.
For example, the reservoir may be located on, or integrated within,
the interior surfaces of the central body portion (101), the distal
tip (106), and/or the wings (102, 103). The channels may provide
lubrication to the outer surfaces of the retractor (100).
[0089] In some embodiments, a significant portion of the device
(100) may be formed from a single continuous material. That is, the
retractor--is formed from only one component. In these embodiments,
the retractor may be manufactured by molding. For example, in an
exemplary embodiment, the central body portion (101), wings (102,
103), and distal tip (106) may be injection molded to form a single
component. An exemplary material for injection molding may be
polypropylene.
[0090] The device (100) may be used in various procedures,
including episiotomy repair, repair of vaginal lacerations, and
visualization during checkups. For example, the ratchet mechanism
(220) may be adjusted to hold the wings (102, 103) in various
positions with respect to each other. For example, the user may
desire to have the wings (102, 103) closer to each other during
insertion and removal of the device (100), while keeping the wings
(102, 103) farther apart from each other to maximize the viewing
and working fields during procedures. Various positions may also be
desired for different body shapes, sizes, or morphologies. The
position of the wings may be changed during procedures using the
ratchet mechanism (220).
[0091] The device may be used for improved visualization, access,
and repair in various procedures, including, but not limited to:
obstetrical/gynecological procedures: vaginal inspection; perineal
inspection; vaginal wound repair; perineal wound repair; episiotomy
repair; female pelvic exam; pap smear; cervical biopsy;
vaginal/pelvic reconstruction; urological procedures; colorectal,
general, or other surgery; the device may be turned upside-down,
for example, for female urologic procedures; access to the cervix
(or uterus via cervix); IUD insertion, removal, or adjustment; and
dilatation & curettage (dilatation of cervix and curettage of
uterus).
[0092] The previous description of embodiments is provided to
enable any person skilled in the art to make or use the retractors
and speculums. Various modifications to these embodiments will be
readily apparent to those skilled in the art, and the generic
principles defined herein may be applied to other embodiments
without departing from the spirit or scope of the retractors and
speculums. Thus, the retractors and speculums are not intended to
be limited to the embodiments shown herein but are to be accorded
the widest scope consistent with the principles and novel features
disclosed herein.
* * * * *