NZ743570A - Ergonomically designed vaginal speculum - Google Patents
Ergonomically designed vaginal speculumInfo
- Publication number
- NZ743570A NZ743570A NZ743570A NZ74357016A NZ743570A NZ 743570 A NZ743570 A NZ 743570A NZ 743570 A NZ743570 A NZ 743570A NZ 74357016 A NZ74357016 A NZ 74357016A NZ 743570 A NZ743570 A NZ 743570A
- Authority
- NZ
- New Zealand
- Prior art keywords
- speculum
- bill
- pawl
- handle
- locking
- Prior art date
Links
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Abstract
The present disclosure relates to an ergonomically designed vaginal speculum. The speculum includes a body portion comprising a handle configured to be grasped by a user of the speculum, a lower bill, and a transition portion between the handle and the lower bill. The speculum further includes an upper bill rotatably coupled to the lower bill at the transition portion, allowing the upper bill to move relative to the lower bill to move the speculum into an open position, a window frame coupled to the upper bill defining a viewing window, and an actuation mechanism coupled to the upper bill to cause separation of the upper bill from the lower bill. The transition portion creates an angle greater than 90 degrees between the handle and the lower bill. The speculum may further include a locking mechanism and an illumination source. per bill rotatably coupled to the lower bill at the transition portion, allowing the upper bill to move relative to the lower bill to move the speculum into an open position, a window frame coupled to the upper bill defining a viewing window, and an actuation mechanism coupled to the upper bill to cause separation of the upper bill from the lower bill. The transition portion creates an angle greater than 90 degrees between the handle and the lower bill. The speculum may further include a locking mechanism and an illumination source.
Description
/069045
ERGONOMICALLY ED VAGINAL SPECULUM
CROSS-REFERENCE TO RELATED ATIONS
This ation claims the benefit of and priority to US. Provisional Patent
Application No. 62/272,616 filed December 29, 2015, and entitled “Ergonomic Handle for
Medical Speculum.” This application also claims the benefit of and priority to US.
Provisional Patent Application No. 62/281,690 filed January 21, 2016, and entitled
“Ergonomic Handle for Medical um.” This application also claims the benefit of and
priority to US. Provisional Patent Application No. 62/310,602 filed March 18, 2016, and
ed omic Handle for Medical Speculum.” Each of the aforementioned provisional
applications is incorporated herein by reference in its entirety.
BACKGROUND
The present ion relates generally to the field of medical speculum.
A speculum is a medical tool used to provide visualization into a body cavity.
Speculums or specula are traditionally used for viewing the vaginal cavity for gynecology
patients. The traditional vaginal speculum consists of two bills with a hinge and a handle. The
bills are inserted into the body cavity in a closed position and separated by ing two
pieces of the handle together, or depressing a thumb lever, thereby ng the vagina and
providing visualization and accessibility of the vagina, the cervix, and surrounding areas.
Once opened, the speculum can be locked in an open position using a screw based
mechanism so an operator (e.g., physician, nurse, mid-wife, etc.) does not need to continue
squeezing the pieces of the handle, or depressing the thumb lever, during the inspection. The
operator can then proceed with inspecting the vagina, conducting a Pap smear or any other
medical procedures that may need to be provided.
Embodiments herein generally relate to improved speculum devices, components of
the same, and methods of making and using the same. The devices and components
me many drawbacks of existing speculum devices. For example, described herein
according to some embodiments are speculum devices that provide a more comfortable and
easily manipulated handle design, sing the repetitive stress injuries that routinely occur
with providers, while also reducing discomfort for the patient.
SUMMARY OF THE INVENTION
The double bill design of speculum devices has been in use since the 18005 and not
many changes have been made to the original . The biggest changes that have been
seen with the double bill design are the addition of plastic as a speculum material, and the
addition of internal lighting on some models of the plastic speculum so that the operator does
not have to rely on external lighting to get a clear view of the vagina and the cervix. About 15
years ago, an inflatable speculum was developed, but failed to gain any traction in the market
and was y discontinued.
In the traditional design, speculums include a handle portion and a body portion
positioned at substantially 90 degrees relative to one another. In this configuration, insertion
into the vagina and maintenance in that position may be difficult and uncomfortable for the
practitioner and the patient.
rmore, ional designs incorporate two handle portions to be ed
together, or a lever to be depressed, to expand the body portion of the speculum. This, too, is
difficult for the tioner with time, due to the ergonomic issues of repeated , often
times multiple times a day. And finally, to hold the speculum in the opened position,
speculums of the traditional metal design incorporate a screw and locking nut apparatus
wherein once the desired ion is achieved, the practitioner locks it in by screwing the
nut along the shaft until it locks the speculum in place. This is problematic because it requires
the practitioner to use both hands to lock in the opened position.
ums are traditionally made of metal, though some made with disposable
plastic have been increasing in use. When the speculum is made of metal, it can feel cold
upon entry, especially in comparison to the internal temperatures of the body, ing
discomfort for the patient during the procedure, resulting in the patient tensing up and making
the procedure more painful. However, even when made of plastic, the design of the speculum
may be generally the same, but for some differences that may exist in the locking
mechanisms, wall ess, and consistencies between the types of plastic.
As noted above, embodiments herein lly related to improved speculum
devices, components of the same, and method of making and using the same. The devices and
components overcome many drawbacks of existing speculum devices. For example,
described herein according to embodiments are speculum devices that minimize the
discomfort for the operator.
In one embodiment there is a speculum that includes a body portion comprising a
handle configured to be grasped by a user of the speculum, a lower bill, and a tion
portion n the handle and the lower bill. The speculum further includes an upper bill
rotatably coupled to the lower bill at the transition portion, ng the upper bill to move
relative to the lower bill to move the speculum into an open position, a window frame
d to the upper bill defining a viewing window, and an actuation mechanism coupled to
the upper bill to cause separation of the upper bill from the lower bill. The transition portion
creates an angle greater than 90 degrees between the handle and the lower bill. In some
embodiments, the angle is in the range of 100 degrees to 180 degrees.
In some embodiments, the speculum further includes a g mechanism
configured to hold the speculum in the open position by preventing movement of the upper
bill relative to the lower bill when the locking mechanism is engaged. In some embodiments,
the locking mechanism includes a locking strip having an ment t, a pawl for
interacting with the engagement element which, when interacting, prevents nt of the
locking strip in at least one direction relative to the pawl, and a lock switch configured to be
ed to cause interaction of the pawl with the engagement element. In some
embodiments, the engagement element is an aperture in the locking strip configured to
receive a portion of the pawl which, when interacting, ts movement of the locking strip
relative to the pawl. In some embodiments, the engagement element is a tooth extending from
the locking strip configured to interact with a portion of the pawl which, when interacting,
prevents movement of the locking strip in one direction relative to the pawl.
In some embodiments, the actuation mechanism is a thumb tab coupled to the
window frame. In some embodiments, the speculum further includes an nation .
In some embodiments, the illumination source is a lighting module having a housing
comprising a front plate and a back plate, a ng element, a power source, and an
tion mechanism for providing power to the lighting element prior to use. In some
embodiments, the lighting element is an LED. In some embodiments, the power source is a
y. In some embodiments, the activation mechanism is a pull tab provided between a
first and a second battery to prevent discharge of the ies, and wherein when the pull tab
is removed, the first and the second battery become electrically coupled and provide power to
the lighting element.
In some embodiments, all edges and shape transitions on an outer surface of the
handle are rounded. In some embodiments, the speculum further includes a gripping portion.
In some ments, the ng portion es at least a portion made of a different
al than a material of the um. In some embodiments, the gripping portion includes
an overmold placed over the handle. The overmold may be silicone or other similar material.
In another embodiment, there is a locking mechanism for a speculum having a
handle, a first bill, and a second bill, the locking mechanism includes a locking strip having
an engagement element, the locking strip coupled to the first bill and configured to move in
unity with the first bill, a pawl for interacting with the engagement element which, when
interacting, prevents movement of the locking strip in at least one direction relative to the
pawl, thereby ting movement of the first bill relative to the second bill, and a lock
switch configured to be actuated to cause interaction of the pawl with the ment
t and prevent movement of the locking strip in at least one direction relative to the
pawl.
In some embodiments, the engagement element is an aperture in the locking strip
configured to receive a portion of the pawl which, when cting, prevents movement of
the locking strip relative to the pawl. In some embodiments, the engagement element is a
tooth extending from the locking strip configured to interact with a portion of the pawl which,
when interacting, prevents movement of the locking strip in one direction relative to the pawl.
In yet another embodiment, there is a lighting module for a speculum having a
housing comprising a front plate and a back plate, a lighting element, a power source; and an
tion mechanism for providing power to the lighting element prior to use. In some
embodiments, the lighting element is an LED. In some embodiments, the power source is a
battery. In some embodiments, the activation mechanism is a pull tab provided n a
first and a second battery to prevent discharge of the batteries, and wherein when the pull tab
is removed, the first and the second battery become electrically coupled and e power to
the lighting element.
In yet another ment, there is method of performing a medical procedure on a
female, sing, providing a speculum according to any of the embodiments described
above, ing the um into the vagina of a female patient, and performing the medical
procedure.
In yet another embodiment there is a method of reducing hand fatigue or injury in a
medical professional using a speculum, comprising, providing a speculum according to any
of the embodiments described above to the sional for use in a female medical
procedure.
BRIEF DESCRIPTION OF THE DRAWINGS
is a side View of a speculum according to an exemplary embodiment.
FIGS. 2A-2B are end views of various embodiments of the bills of the speculum of
is a cross sectional view of an embodiment of the bills of the speculum of
is a rear perspective view of the speculum of
is a front perspective view of the speculum of
is a cross sectional view of the speculum of
is a rear perspective view of a locking mechanism of the speculum of FIG.
is an inside perspective view of a portion of a handle of the speculum of FIG.
is a perspective view of a speculum according to a second exemplary
embodiment having a lighting module.
is an exploded view of the lighting module of
is a perspective view of a back plate of the ng module of
A depicts a front perspective view of a first alternative actuation feature for
expanding the expandable body of a speculum.
B depicts a side view of the first alternative actuation feature for expanding
the expandable body of a speculum.
A depicts a side view of a second alternative actuation feature for expanding
the expandable body of a speculum.
B s a front perspective View of the second alternative actuation feature
for expanding the expandable body of a speculum.
C depicts a side view of a third alternative actuation feature for expanding
the expandable body of a speculum.
D depicts a front perspective view of the third ative actuation feature
for expanding the expandable body of a speculum.
depicts a front perspective view of the fourth ative actuation feature
for ing the expandable body of a speculum.
DETAILED PTION
In the ing detailed description, reference is made to the accompanying
drawings, which form a part of the present disclosure. In the drawings, similar symbols
typically identify similar components, unless context dictates otherwise. The rative
embodiments described in the detailed description, gs, and claims are not meant to be
limiting. The detailed description is intended as a description of exemplary embodiments and
is not ed to represent the only embodiments which may be practiced. The term
“exemplary,” as used herein, means “serving as an example, instance, or illustration,” and
should not necessarily be construed as preferred or advantageous over other embodiments.
Other embodiments may be ed, and other changes may be made, without departing from
the spirit or scope of the subject matter ted here. It will be readily understood that the
aspects of the present disclosure, as generally described herein, and illustrated in the figures,
can be arranged, tuted, combined, and designed in a wide variety of different
configurations, all of which are itly contemplated and form part of this sure.
Referring to the figure generally, a speculum system is shown. The speculum is an
updated design ve to the ated, traditional two-bill design. The speculum has an
ergonomic handle for increased comfort during use. Without being limited thereto, in some
embodiments, the handles described herein can have one or more features selected from a
greater angle between the grip or the handle portion and the bills of the speculum, a ed
grip on the handle, the size of the handle, etc. As one example, the larger angle can be
beneficial so that the handle does not interfere or contact patient as readily while being
inserted, while ed, or when removed and also can be more comfortable for the user by
providing a neutral position for the wrist. As another example, the ergonomic handle with a
textured grip can provide for improved precision during use, for example, due to ergonomic
touch points. The improvements can minimize hand fatigue or other stresses to the hand
including carpel tunnel problems for the user. In on, an improved locking mechanism
can allow the speculum to be used with one hand, as opposed to locking isms that
require the use of two hands. In some embodiments, the profile of the speculum, for example
the bill portion, may be narrower than traditional speculum while still maintaining an equal or
greater level of usability. In some embodiments, the speculum may be used with a sleeve that
can be placed over the bill portion to provide side wall t. The sleeve may be
disposable, le, lubricated, or include a therapeutic agent.
depicts a speculum 100 having an upper bill 102, a lower bill 104, a handle
106, a viewing window 110, and an actuation mechanism. The speculum 100 shown in has an updated ergonomic design in accordance with certain ments of an updated
speculum. The speculum 100 may be made of any sturdy biomaterial including metals and
plastics. The lower bill 104 and the handle 106 are formed together as a unitary body portion.
The upper bill 102 is rotatably coupled to a tion portion 104a between the lower bill 104
and the handle 106 such that the upper bill is movable between an open position and a closed
position when the actuation mechanism, such as the ion tab 108 is manipulated. When
the bills 102 and 104 are in the closed position, the speculum 100 can be inserted in a
patient’s vagina. The user places the end 118 in line with an opening of the vagina and
applies a force along a longitudinal axis of the bills 102 and 104 to push the bills 102 and 104
into the vagina. The user may position the speculum 100 at a depth of the vagina to provide a
clear view of the cervix when the bills 102 and 104 of the speculum are opened. The
speculum 100 may be inserted with the handle n in a substantially vertical direction, as
in the orientation of Alternatively, the speculum 100 may be inserted with the handle
portion in a substantially horizontal direction and rotated to a al position once inside the
. The speculum may also be inserted with the bills at a downward 45 degree angle for
patient comfort. The speculum 100 may be inserted so that the end 118 of the bills 102 and
104 are located below the cervix. Once the bills 102 and 104 are separated, the cervix may
then fall into the viewing window created by the separation of the bills 102 and 104.
Alternatively, the speculum may need to be shifted in different directions in order to view the
cervix ly.
The bills 102 and 104 each comprise a transition portion 102a, 104a and a main bill
portion 102b, 104b. The main bill portions 102b, 104b form an elongated portion 116 of the
speculum 100. Various embodiments of the elongated portion 116 are shown in the end views
of FIGS. 2A-2B. The ted portion 116 may have a width that is larger than a height of
the elongated portion, creating an oblong shape, as seen in . Alternatively, the height
and width of the elongated portion 116 may be configured in such a way that when the bills
102 and 104 are , a circular cross section is formed, as seen in . At an end 118
of the elongated portion 116, away from the handle 106, the bills 102 and 104 may be
rounded. A rounded end 118 may provide more comfort to a patient whom will be receiving
the speculum 100 in a cavity. The bills 102 and 104 may also be configured such that when in
the closed position, the end 118 of each bill 102 and 104 may abut one another without any
gaps. In other embodiments, the top bill 102 or the bottom bill 104 may be longer than the
other (see to create a gap when the bills are closed, ting tissue from ng
lodged in between the bills 102 and 104 during insertion or closing of the bills. The bills 102
and 104 may have a semi-circular cross section along a length of the bill 102 and 104, where
the flat portions of the semi-circles are moved together when the bills 102 and 104 are in a
closed position, as seen in . In these embodiments, an outer edge and an inner edge of
the bills are preferably each curved such that when the bills 102 and 104 are in the closed
position, a cross n of the bills 102 and 104 forms a cylinder shape, as seen in .
As shown in speculum 100 es a window 110 defined by a window
frame 112. The window frame 112 is y with the upper bill 102 and extends from a
proximal portion of the tion portion 102a of upper bill 102. The transition portion 102a
is slightly curved such that a top portion of the window frame 112 is positioned higher than
the top of upper bill 102. Referring back to from the transition portion 102a, the
window frame 112 extends at an angle CI) away from handle 106. In some embodiments, the
angle CI) is greater than 25 degrees but less than 40 degrees, or any degree value or sub range
of degrees therein. In some ments, the angle may be between 30 and 35 degrees. In
some embodiments the angle CI) is about 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,
39, 40, 41, 42, 43, 44, or 45 s. In some embodiments, the angle CI) may define the
extent to which upper bill 102 is able to separate from lower bill 104. When window frame
112 contacts handle 106 as force 120 is applied (described below), the contact will limit the
range of motion of the upper bill 102 relative to lower bill 104. In other embodiments, a limit
to the range of motion is provided in another way.
Still referring to the speculum 100 has an actuation mechanism, shown as
actuation tab 108, to cause separation of bills 102 and 104. In this embodiment, ion tab
108 is formed unitary with the upper bill 102 at a lower portion of the window frame 112. A
force 120 is applied, preferably by a thumb of the user, to the actuation tab 108 which causes
the bills 102 and 104 to separate. When force 120 is applied to the actuation mechanism, the
g created by the separation of the bills 102 and 104 is caused by the upper bill 102
moving relative to the lower bill 104 and handle 106. For example, the force 120 applied on
the actuation mechanism causes upper bill 102 to move, while lower bill 104 remains
stationary. In other embodiments, the opening may be caused by both bills 102 and 104
moving, or lower bill 104 moving. Upper bill 102 is preferably coupled to the transition
n 104a by a hinge such that force 120 on the actuation mechanism causes a rotational
movement of bill 102 about the hinge, separating the ends of bills 102 and 104.
In the embodiment shown, tab 108 has a concave surface to ate with the
shape of the thumb of the user and provide a more stable area for the thumb to apply force
120. In some embodiments, the tab 108 is a separate element that is coupled to the window
frame 112. In other embodiments, the tab may be formed unitary with the window frame. The
applied force 120 should not need to be a substantial force. As described above, in some
embodiments, a distance the ion mechanism moves correlates to a distance the bills 102
and 104 separate. In this regard, the user would be able to modify the specific distance
between the bills 102 and 104 for each patient. The bills 102 and 104 may open in a
continuous fashion when force 120 is continuously d to the actuation mechanism. The
user may have to hold the actuation mechanism in place in order to maintain the distance
between the bills 102 and 104. Alternatively, the speculum 100 may have a g
mechanism, such that the bills 102 and 104 can be locked in an open position. In this regard,
the user would not have to maintain re on the actuation mechanism to maintain the
ce between bills 102 and 104.
For example, referring to the cross—sectional View of and to ,
speculum 100 has a locking mechanism which includes a locking strip 124, a pawl 126, and
lock switch 128. g strip 124 is coupled to tab 108 or window frame 112. In some
ments, the locking strip 124 and tab 108 are formed together as a unitary element. In
other embodiments, the locking strip 124 and tab 108 are separable coupled together during
construction of the speculum 100. As force 120 is applied to thumb tab 108, thereby g
bills 102, 104, locking strip 124 moves through a window 130 in a back cover 106a of handle
106 (shown in . The locking strip 124 may include aplurality of teeth 125b. As
locking strip 124 moves with the opening of upper bill 102 from lower bill 104, the teeth
125b of the locking strip 124 move into position to engage with end portion 126a of pawl
126. When end portions 126a of pawl 126 engages in one of the plurality of teeth 125b in the
locking strip 124, the locking strip 124 is prevented from moving in a direction such that the
upper bill 102 is prevented from closing, and therefore, the bills 102, 104 are locked in the
open position. When the lock switch 128 is in a locked position, the teeth 125b will allow
WO 17310 2016/069045
movement of the locking strip 124 relative to the pawl 126 in a direction corresponding with
the opening of the bills 102, 104, and will prevent movement of the locking strip 124 relative
to the pawl 126 in an opposite direction, Locking strip 124 further has a plurality of openings
125a therethrough that are red to e flexibility to the locking strip 124.
According to the ment shown, the locking mechanism further includes lock
switch 128. The pawl 126 includes an aperture 127, through which a connection mechanism
of the lock switch 128 passes through to couple the lock switch 128 inside the handle. As
shown in , when the bottom n 128b of lock switch 128 is toggled, or pressed in,
the end portion 126a of pawl 126 is pressed towards the locking strip 124. The end portion
126a may be spring biased towards the lock strip 124. When aligned with one of the ity
of openings 125a, the end portion 126a engages the locking strip 124. In this way, ng
the bottom portion 128b of the lock switch 128 causes the g strip 124 to be held in
place relative to the pawl 126 and prevents the bills 102, 104 from closing. When the top
portion 128a of lock switch is toggled, or pressed in, the top portion 126b of pawl 126 is
caused to be pressed s the locking strip 124. Accordingly, the engagement between the
pawl 126 and the locking strip 124 is released and the locking strip is able to move relative to
the pawl 126. As a result, upper bill 102 is free to move relative to lower bill 104, and the
speculum 100 is no longer locked. In other embodiments, the locking ism could have
an alternative configuration, wherein the toggling of the lock switch functions in opposition,
for example, pressing the top portion 128a of the lock switch 128 locks the mechanism, and
pressing the bottom portion 128b unlocks the mechanism,
The locking mechanism shown in is configured such that when the lock
switch 128 is in a locked position (e.g., the bottom portion 128b is toggled), the bills 102, 104
are still able to open, but the movement will be incremented due to the engagement of the
pawl with the teeth. In this way, there will be resistance and noise associated with opening
the bills 102, 104. As mentioned above, in the locked position, the bills are substantially
prevented from closing unless a force in the opposite direction is applied. In order to open the
bills freely (i.e., limited noise or resistance) and/or to close the bills, the lock switch should
be moved to the unlocked position (e.g., top portion 128a toggled). The ability to open the
speculum with minimal resistance and noise is an improvement over the presently used
um designs.
Once the user has completed the inspection of the vaginal cavity and cervix, the bills
102 and 104 may be ed to the closed or mostly closed position prior to or during
l the speculum 100 from the patient. To return the bills 102 and 104 to the closed
position, the user may release the force 120 from the actuation ism. Removing force
120 would work to close the bills 102 and 104 if the force 120 needed to be applied for the
length of the procedure to maintain the viewing window. However, if the actuation
mechanism locks into place when force 120 is applied, a user will unlock the speculum to
close the bills 102 and 104. For example, using the locking mechanism depicted in a
user would press the lower portion 128b of the lock switch 128 to disengage the pawl 126
from the locking strip 124, and therefore, unlock the speculum 100 to close the bills 102 and
104.
In alternative embodiments, a second force may be applied to the actuation
mechanism to close the bills 102 and 104. The second force may be applied in a ion
opposite of force 120. The second force should be small enough so as to be easy to apply
with an upward movement of the thumb of the user. The user should be able to apply the
second force while maintaining control of the um 100. Alternatively, the actuation
mechanism may be released by applying a second force 120 to the actuation mechanism to
move the actuation mechanism past the g position, releasing the lock and closing the
bills 102 and 104.
Once the bills 102 and 104 of the speculum 100 are closed, the um 100 can be
removed from the patient. When closing the bills 102 and 104, the user should take caution to
ensure no vaginal tissue is between the bills 102 and 104 such that the tissue may become
pinched when closed. The speculum 100 should then be pulled along an axis along the length
of bills 102 and 104 to easily remove the bills 102 and 104 from the t.
The actuation mechanism should be located at a position such that the user is able to
easily reach the actuation mechanism with a thumb when the rest of a hand of the user is
holding handle 106. In the embodiments of FIGS. 1 and 3-5, the actuation mechanism is
located on a proximal end of the upper bill 102, coupled or unitary with the window frame
112. In some alternative embodiments of a speculum, not depicted in the figures, an actuation
mechanism may be located on the handle 106 on a user side (i.e., the side of the handle
opposite the bills 102 and 104). The ion mechanism may be located along a center axis
of the handle 106. In this , the speculum 100 could be used in both a right hand or a left
hand. In the embodiments shown herein, the actuation tab 108 is aligned with a center axis of
the handle 106. Alternatively, the actuation mechanism may be offset from the center axis of
the handle 106. In this regard, the location of the actuation mechanism may cause the
speculum 100 to be suited specifically for either a right hand or a left hand. If the actuation
mechanism is located on the user side of the handle 106 opposite the bills 102 and 104, the
user side of the handle 106 may be substantially flat to facilitate coupling of the actuation
mechanism and the handle 106. In another embodiment, the actuation mechanism lever 108
may be located on an edge of the handle 106. In this regard, the speculum 100 is configured
to be used by either a right hand or a left hand depending on which edge of the handle 106 is
coupled to the actuation mechanism.
Referring to FIGS. 1 and 3-5, it is shown that the speculum 100 employs an obtuse
angle 0 between the bill 104 and the handle 106, which is more comfortable for both the
tioner and the t during use. The transition portion 104a creates the angle 0
between the lower bill 104 and the handle 106. In some embodiments, the angle 0 is greater
than 90 degrees but less than 180 s, or any degree value or sub range of degrees
n. In some ments, the angle may be between 100 and 150 degrees. In some
ments, the angle 6 is about 95, 100, 105, 110, 115, 120, 125, 125, 130, 135, 140, 145,
150, 155, 160, 165, 170 or 180 s. The angle 0 provides a more comfortable angle for
the user to insert the speculum 100 into the vagina of the patient. In addition, the angle 0
provides more room for the hand of the user when inserting the speculum 100. This reduces
the risk of the hand of the user coming into contact with the patient when inserting the
speculum 100, which can be uncomfortable and awkward for the patient. This also can reduce
the possibility or degree of interference during use due to contacting the body of the patient,
as well as the examination table or bed that the patient may be seated or lying upon, for
example. The angle 0 also provides a more comfortable angle for a wrist of the user during
2016/069045
the procedure. This reduces the risk of injury or strain to the hand or wrist of the user,
especially when the user completes multiple procedures in a single day, or day after day.
The handle 106 may also be rounded, lacking sharp comers and edges, and have a
circular cross section to provide a more comfortable and natural fit in the hand of the user.
Alternatively, a patient side of the handle 106 may be rounded while a user side may be flat.
This configuration may provide the user a flat portion to rest a thumb of the user during the
procedure. In another embodiment, both the user and patient sides are rounded, but with
different curvatures such that the cross section is more oblong than circular. The handle 106
may e a grip 114 for comfort and ergonomic benefit. The grip 114 may be of a material
that provides more traction for the hand of the user, for example, the grip 114 may be an
overmold placed over a portion of the handle. The overmold may be silicone or other similar
material. In some ments, the grip 114 is textured to provide more traction for the hand
of the user. For example, the grip 114 may include bumps, dimples, and/or other texturizing
elements, and a rounded or formed body for comfort and ergonomic benefit. The grip texture
can include any suitable feature to permit gripping of the handle. For example, the texture
can include raised elements or protrusions such as bumps, ridges (e.g., vertical or horizontal,
straight or waved, etc), and/or indentations or holes, which can be in the shape of pinholes,
grooves, ls, etc. The grip 114 may allow the user to apply less force with the hand of
the user in order to hold the speculum 100. By allowing the user to use less force to hold the
speculum, the user may become less fatigued when performing the procedure. In addition,
when less force is needed, the user may experience less cramps, strains and/or es caused
by using the speculum 100. The grip 114 may extend the length of the handle 106. In some
ments, the grip 114 only extends a portion of the length of the handle 106. In some
embodiments, the grip 114 may be located only on the user or patient side of the handle 106.
In other embodiments, the grip 114 may be located on both the user and patient side of the
handle 106 in separate pieces. In another embodiment, the grip 114 wraps around the
circumference of the handle 106. In yet another embodiment, the grip 114 is a plurality of
pieces spaced along the handle 106. In another embodiment, the grip 114 is made of s
d along the handle 106, where the grooves align with where fingers of the user would
be located when g the handle 106. The grip 114 may also provide for ning the
practitioner’s hold on the handle, and/or for a more secure grip on the device.
The handle 106 may be made of metal and/or c, including, but not limited to,
um, aluminum, stainless steel, acrylic, hylene, polyester, polyethyleneaphthlate,
polystyrene, polyvinylchloride, hersulfone, polyetherimide, polycarbonate,
polysulfone, polyetheretherketone, polyphenylsulfone, and polymethyl methacrylate. The
handle 106 may be made of a material that can be sterilized. The handle 106 may be made of
material that is biocompatible. The handle 106 may be made using a variety of techniques
including, but not limited to, injection molding, extrusion, machining, blow molding,
rotational molding, compression g, transfer molding, ng, and casting.
depicts another embodiment of the speculum 100 having a lighting module
200. In this embodiment, the lighting module 200 is Y-shaped, having a base section 200a
and two extensions 200b. The lighting module 200 is positioned in the window 110 and held
in place by engagement with the window frame 112. For example, the lighting module 200
may have a snap fit relationship with the window frame 112. In other embodiments, the
lighting module may be attached to the window frame 112 using fixation devices (i.e.,
screws, nails, etc) or adhesive (i.e., tape or glue). The base section 200a is configured to
replace the thumb tab 108, but on in the same way as thumb tab 108 for providing an
actuating mechanism for opening the bills 102 and 104. The lighting module is configured to
illuminate the cavity in which the speculum 100 is placed in order to allow better
visualization of the cavity and execution of procedures in the cavity. The lighting module 200
provides one or more nation elements, such as LEDs 204. The configuration of the
lighting module 200 provides illumination elements at or near the perimeter of the window
110 at window frame 112, so as not to obstruct the view of the user through the window 110.
In the embodiment shown, an illumination element is oned on each side of the window
frame 112. The illumination t(s) may alternatively be positioned near any part of the
window frame 112. In some embodiments, one or more of the illumination elements may be
positioned to interface with one or more light pipes which extends through at least a portion
of the length of the top bill 102, thereby directing light through the bill 102.
As shown in lighting module 200 includes a back plate 202, an LED 204, a
resistor (not shown), a y 206, a front plate 208, and a pull tab 210. The back plate 202
and the front plate 208 form a housing to carry the elements of the lighting module 200. In
some embodiments, the lighting module 200 includes more than one LED 204. In some
red embodiments, the ng module 200 includes two LEDs 204. The LED may be
any color suitable for providing lighting to the cavity. In preferred embodiments, the LED is
clear or white. Various sizes of LEDs 204 can be used in lighting module 200, such as 1 mm,
3mm, 5mm, and 10mm LEDs. In order to limit current into the LED 204, so as not to burn
out the LED 204, a resistor (not shown) is used in series with the LED 204 in the lighting
module 200. The value of the resistor needed depends on the forward current and the forward
voltage specifications of the LED 204 (variable), and on the power source voltage.
Lighting module 200 also es a power source, such as one or more batteries. In
the embodiment shown, two button cell batteries 206 are used to power each LED 204
electrically d thereto gh in line resistors). Each battery 206 preferably has a
voltage of about 3.0V, but batteries having other voltages may also be used. The lighting
module also includes an activation mechanism which can be manipulated to cause the LEDs
to go from an “off” state to an “on” state. In this ment, the activation mechanism is a
pull tab 210 oned between the batteries, thereby preventing rge of the batteries
and keeping the LEDs “of .” The pull tab 210 is configured to be pulled by the user to
dislodge the pull tab 210 from between the batteries 206, thereby allowing the flow of current
and providing power to the LEDs. In this embodiment, there is no mechanism for powering
the LEDs off after they have been turned on. In some embodiments, the same activation
mechanism may be used to power off the LEDs or there may be a second ism for
powering off the LEDs.
shows a perspective view of the back plate 202, which is ured to
receive and hold the elements of the lighting module 200 therein. As shown, the back plate
has an LED aperture 214 at the top of each extension 20% for each LED 204. An LED 204 is
positioned in each aperture 214 and can illuminate through into the cavity. Along each
extension 20% is a passage 216 along which the legs of each LED 204 and the inline
resistors are positioned, to connect with the batteries 206. One passage 216 leads to one pair
of batteries 206 while the other passage 216 leads to the other pair of batteries, as shown in
the figure. The back plate 202 further includes a battery receptacle 218 for receiving the
batteries 206. A slot 220 is located at a bottom edge 222 of the back plate, through which the
pull tab 210 extends before it is removed by the user.
FIGS. 10-12 depict alternative embodiments of a speculum according to the present
invention. It is contemplated that any of the es, or combinations thereof, recited above
may be used with any other features described in other embodiments, ing the features
bed with reference to FIGS. 10-12. Specifically, FIGS. 10-12 relate to various
alternative ments of the actuation feature for opening, locking, and/or closing the bills
102 and 104 ofthe speculum 100.
FIGS. 10A and 10B depict a scroll and press mechanism, in accordance with an
exemplary embodiment. With the scroll and press mechanism, the distance between the bills
102 and 104 can be set while expanding or prior to expanding the speculum within the
patient.
The scroll and press ism includes a scroll wheel 140. The scroll wheel 140
may be embedded into the handle 106 such that only a n of the scroll wheel 140 is
visible and accessible to the user. The scroll wheel 140 can be rotated in two directions.
When the scroll wheel 140 is rotated in a first direction, the diameter of the speculum 100
increases. The increase in diameter moves the bills 102 and 104 further away from one
another while in the closed position. When the scroll wheel 140 is rotated in a second
direction, the diameter of the speculum 100 decreases. The decrease in er moves the
bills 102 and 104 closer to one another. The user may obtain a better view of the cervix by
properly adjusting the diameter of the speculum 100 to the diameter of the cervix in the
vagina. The scroll wheel 140 may also include ridges or grooves 142 to allow the user to
rotate the scroll wheel 140 more easily. In some embodiments, the ridges or grooves 142
provide an indication of the diameter the speculum. The scroll wheel 140 may provide fluid
increases and decreases in er as the scroll wheel 140 is rotated. Alternatively, the scroll
wheel 140 may provide fixed ses and decreases in diameter as the scroll wheel 140 is
rotated. For example, a full 360 degree rotation may be needed to increase or decrease the
er by a set amount. The user may have the ability to lock the scroll wheel 140 into
place when an appropriate diameter is selected. Subsequently, the user may be able to unlock
the scroll wheel 140 when the examination has concluded.
The scroll wheel 140 may be located on the handle 106. The scroll wheel 140 should
be located in such a way that the user can easily rotate the scroll wheel 140 with a thumb
while maintaining a secure grip on the handle 106. The scroll wheel 140 should not interfere
with the ability of the user to move and adjust the placement of the speculum 100 into the
vagina of the patient.
FIGS. 11A-11D depicts an alternative ion or locking feature in accordance
with certain embodiments of the speculum. The actuation feature of FIGS. 11A-4D use a
squeeze and slide mechanism to open and/or lock the speculum.
The squeeze and slide mechanism includes a groove 152. The groove 152 is an
elongated opening that provides a track for a slider 154. The groove 152 may be rounded at
each end. The groove 152 may be located on the handle 106 of the speculum 100. The groove
152 has a length that is shorter than a length of the handle 106. Inside the groove 152 is a
mechanism that opens and closes the bills, basedon the movement of the slide 154. In other
embodiments, an actuation mechanism as described above with respect to speculum 100 may
be used, and the slide 154 is used to move between a locked and an unlocked state.
The slider 154 has an elongated body and can be moved in two directions along the
groove 152. nt in a first ion causes the bills 102 and 104 to separate, increasing
the diameter of the opening created by the speculum 100. Movement in a second direction
causes the bills 102 and 104 to close, sing the diameter of the opening d by the
bills 102 and 104. In other embodiments, where the bills are opened by a separate actuation
mechanism, movement in the first direction causes the speculum to lock and movement in
the second direction causes the speculum to , or vice versa. The slider 154 may have a
rounded, elongated body to tate the placement of the thumb on the slider 154. The slider
154 should be d in such a way that the user can easily apply a force to the slider 154
with the thumb while maintaining a secure grip on the handle 106. The slider 154 should not
interfere with the ability of the user to move and adjust the placement of the speculum 100
into the vagina of the patient.
In one embodiment, the slider 154 includes a spacer 156 to raise the slider 154 out
of the groove 152. In this embodiment, the user applies a force 158 to the slider 154. The
force 158 causes the slider 154 to abut the groove 152 and activate the intemalmechanism,
The user can slide the slider 154 up and down along groove 152 while force 158 is applied to
adjust the diameter of the opening created by the bills 102 and 104 and/or move between a
locked and ed position. Once force 158 is removed from slider 154, spacer 156 is
visible again. The slider 154 is locked into place when no force is d.
In other embodiments, the slider 154 s flush with the groove 152. In this
embodiment, the user applies a force 160 to the slider 154, to slide the slider 154 up and
down along groove 152 to adjust the diameter of the opening created by the bills 102 and 104
and/or move between a locked and unlocked position. Once force 160 is removed from slider
154, the slider 154 is held in place.
Fig. 12 depicts an alterantive actuation or locking feature in accordance with n
embodiments of the speculum. The actuation feature of Fig. 12 uses a guide and lock
mechanismto open and/or lock the speculum.
The mechanism of Fig. 12 includes a base 170, a groove 172, a guiding member 174
and a locking member 176. In some embodiments, the base 170 may be coupled to the
actuation mechanism, such as actuation tab 108, of the um. In another embodiment, the
base 170 may be coupled to the handle 106 of the speculum. The groove 172 may extend
through a depth of the base 170. In some embodiments, the groove 172 may extend
longitudinally for a length of the base 170. In some embodiments, the groove 172 may extend
longitudinally for only a portion of the length of the base 170. The guiding member 174 may
be coupled to the speculum on a first end. A second end of the g member 174 may
extend through the groove 172. The configuration of the guiding member 174 may allow the
base 170 to move up and down at an angle keeping the guiding member 174 positioned in the
groove 172.
The nt of the guiding member 174 in on to the base 170 may cause the
bills of the speculum to separate. To lock the bills in an open position, the locking member
176 may be moved in a first direction (e. g., in an upward direction), along a longitudinal axis
of the base 170. The locking member 176 may use groove 172 as a track to slide.
Alternatively, locking member 176 may use a separate aperture to slide. To unlock the bills
2016/069045
(i.e., return the bills to a closed position), the g member 176 may be moved in a second
direction (e. g., in a downward direction), along the longitudinal axis of the base 170. The
locking member 176 may be shaped to conform to the shape of a thumb or finger of the user.
The locking member 176 may also e a ridge to increase the ease of moving the locking
member 176. The ridge may be centered on the locking member 176 and orientated
perpendicular to the longitudinal axis of the base 170. The locking member 176 may be
shaped to conform to the shape of guiding member 174 when in the locked position.
For the practitioner, the features of the present sure may reduce e and
repetitive stress injury, allow for one-handed opening and locking, allow increased visibility
and accessibility, along with many other benefits. For the patients, these features may reduce
t anxiety because they employ quieter mechanisms than the traditional designs and
because of the updated look of the lever 108 and handle 106.
Some embodiments herein relate to methods of performing obstetric or
gynecological procedures utilizing speculum devices having a handle with one or more of the
features described herein. miting examples of such procedures include pelvic exams,
pap smears, insemination, IUD insertion/removal. In some embodiments, the methods can
include performing a plurality of such procedures in a given period of time, such as an 8 hour
or 24 hour period of time, or any sub period of time n. Other embodiments relate to
methods of reducing hand fatigue or repetitive use injury in a user of a device or handle as
described herein.
The foregoing ption details certain embodiments of the systems, devices, and
methods disclosed herein. It will be appreciated, however, that no matter how detailed the
foregoing appears in text, the devices and methods can be practiced in many ways. As is also
stated above, it should be noted that the use of particular terminology when describing n
features or aspects of the technology should not be taken to imply that the ology is
being redefined herein to be restricted to including any specific characteristics of the features
or aspects of the technology with which that terminology is associated. The scope of the
disclosure should therefore be construed in accordance with the appended claims and any
equivalents thereof.
2016/069045
It will be appreciated by those skilled in the art that various modifications and
changes may be made without departing from the scope of the described technology. Such
modifications and changes are intended to fall within the scope of the embodiments, as
defined by the appended claims. It will also be appreciated by those of skill in the art that
parts included in one embodiment are interchangeable with other embodiments; one or more
parts from a depicted embodiment can be ed with other depicted embodiments in any
combination, For example, any of the various components described herein and/or depicted
in the Figures may be combined, interchanged or excluded from other embodiments.
The devices, components, s and systems described herein can be combined
with one or more of the s, components, methods and systems described in any of US.
Patent Application entitled lum with Secondary Bills,” filed on December 28, 2016
and identified by Atty. Docket No. 112359-0253, US. Patent Application entitled “Insertable
Sleeve for Speculum and Use f,” filed on December 28, 2016 and identified by Atty.
Docket No. 112359-0353, and US. Patent Application entitled “Sleeve for Speculum and
Use Thereof,” filed on December 28, 2016 and identified by Atty. Docket No. 112359-0403,
each of which is incorporated herein by reference in its ty.
With respect to the use of any plural and/or singular terms herein, those having skill
in the art can translate from the plural to the singular and/or from the ar to the plural as
is riate to the context and/or application. The s singular/plural permutations
may be expressly set forth herein for sake of y.
It will be understood by those within the art that, in general, terms used herein, and
especially in the appended claims are lly intended as “open” terms (e.g., the term
“including” should be interpreted as “including but not limited to,” the terms “comprising”
and “having” should, respectively, be interpreted as “comprising at least” and “having at
least,” the term “includes” should be interpreted as “includes but is not limited to,” etc). It
will be r understood by those within the art that if a specific number of an introduced
claim recitation is intended, such an intent will be explicitly recited in the claim, and in the
absence of such recitation no such intent is present. For example, as an aid to understanding,
the following appended claims may contain usage of the introductory phrases “at least one”
and “one or more” to introduce claim recitations. However, the use of such phrases should
-2]-
WO 17310
not be construed to imply that the introduction of a claim recitation by the indefinite articles
“a” or “an” limits any particular claim containing such introduced claim recitation to
embodiments containing only one such recitation, even when the same claim includes the
introductory phrases “one or more” or “at least one” and indefinite articles such as (.4 an
a or
(Can.” In general, “a” and/or “an” should be interpreted to mean “at least one” or “one or
more”, the same holds true for the use of definite articles used to introduce claim recitations.
Furthermore, in those instances where a convention analogous to “at least one of A,
B, and C, etc.” is used, in general, such a construction is intended in the sense one having
skill in the art would understand the convention (e.g., “a system having at least one of A, B,
and C” would include but not be limited to systems that have A alone, B alone, C alone, A
and B er, A and C together, B and C together, and/or A, B, and C together, etc.). In
those ces where a convention analogous to “at least one of A, B, or C, etc.” is used, in
general such a construction is intended in the sense one having skill in the art would
tand the tion (e. g., “a system having at least one of A, B, or C” would include
but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C
together, B and C er, and/or A, B, and C together, etc). It will be further understood
by those within the art that virtually any disjunctive word and/or phrase presenting two or
more alternative terms, whether in the description, claims, or drawings, should be understood
to contemplate the possibilities of including one of the terms, either of the terms, or both
terms. For example, the phrase “A or B” will be understood to e the possibilities of
“A” or “B” or “A and B.”
The technology disclosed herein has numerous ations and while particular
embodiments of the technology have been described in detail, it will be apparent to those
skilled in the art that the disclosed embodiments may be modified given the design
considerations discussed herein. Therefore, the foregoing description is to be considered
exemplary rather than limiting, and the true scope of the invention is that defined in the
ing claims.
2016/069045
Claims (26)
1. A speculum comprising: a body portion comprising a handle configured to be grasped by a user of the speculum, a lower bill, and a transition portion between the handle and the lower bill; an upper bill rotatably d to the lower bill at the transition portion, ng the upper bill to move relative to the lower bill to move the speculum into an open on, a window frame coupled to the upper bill defining a viewing window; and an actuation mechanism coupled to the upper bill to cause separation of the upper bill from the lower bill; wherein the transition portion creates an angle r than 90 degrees between the handle and the lower bill.
2. The speculum of claim 1, wherein the angle is in the range of 100 degrees to 180 degrees.
3. The speculum of claim 1, further comprising a locking mechanism configured to hold the speculum in the open position by preventing movement of the upper bill toward the lower bill when the locking mechanism is engaged.
4. The speculum of claim 3, wherein the g mechanism comprises: a locking strip having an engagement element; a pawl for interacting with the engagement element which, when interacting, prevents movement of the locking strip in at least one direction relative to the pawl; a lock switch configured to be actuated to cause interaction of the pawl with the engagement element.
5. The speculum of claim 4, wherein the engagement t is an aperture in the locking strip configured to receive a portion of the pawl which, when cting, constrains movement of the locking strip relative to the pawl.
The speculum of claim 4, n the engagement element is a tooth extending from the locking strip red to interact with a portion of the pawl which, when interacting, prevents nt of the locking strip in one ion relative to the pawl.
The speculum of claim 3, wherein when the locking element is disengaged, the upper bill moves relative to the lower bill without resistance and without sound.
The speculum of claim 1, wherein the actuation mechanism is a thumb tab d to the window frame.
The speculum of claim 1, r comprising an illumination source.
10. The speculum of claim 9, wherein the illumination source is a lighting module comprising: a housing comprising a front plate and a back plate; a lighting element; a power source, and an activation mechanism for providing power to the lighting element prior to use.
11. The speculum of claim 10, wherein the actuation mechanism is a thumb tab and wherein the thumb tab comprises a n of the lighting module.
12. The speculum of claim 10, wherein the lighting element is an LED.
13. The speculum of claim 10, wherein the power source is a battery.
14. The speculum of claim 10, n the activation mechanism is a pull tab provided between a first and a second battery to prevent discharge of the batteries; and wherein when the pull tab is removed, the first and the second battery become electrically coupled and e power to the lighting element.
15. The speculum of claim 1, wherein all edges and shape transitions on an outer surface of the handle are rounded.
16. The speculum of claim 1, r comprising a gripping portion.
17. The speculum of claim 16, wherein the gripping portion comprises at least a portion made of a different material than a material of the speculum.
18. The speculum of claim 17, wherein the gripping portion comprises an ld placed over the handle.
19. A locking mechanism for a speculum comprising a handle, a first bill, and a second bill, the g mechanism comprising: a locking strip having an engagement element, the locking strip coupled to the first bill and configured to move in unity with the first bill; a pawl for cting with the engagement element which, when interacting, prevents movement of the locking strip in at least one ion relative to the pawl, thereby preventing movement of the first bill relative to the second bill, a lock switch configured to be actuated to cause interaction of the pawl with the engagement element and t movement of the locking strip in at least one direction relative to the pawl.
20. The locking mechanism of claim 19, wherein the engagement element is an aperture in the g strip red to receive a portion of the pawl which, when interacting, prevents movement of the locking strip relative to the pawl.
21. The locking mechanism of claim 19, wherein the engagement element is a tooth extending from the locking strip configured to interact with a portion of the pawl which, when cting, prevents movement of the locking strip in one direction relative to the pawl.
22. A lighting module for a speculum, comprising: a housing comprising a front plate and a back plate; a lighting element; a power source; and an activation mechanism for providing power to the ng element prior to use.
23. The lighting module of claim 22, wherein the lighting element is an LED.
24. The lighting module of claim 22, wherein the power source is a battery.
25. The lighting module of claim 22, wherein the activation mechanism is a pull tab provided between a first and a second battery to prevent rge of the batteries; and wherein when the pull tab is removed, the first and the second battery become electrically d and provide power to the lighting t.
26. Use of a speculum device according to any of claims 1-18, a speculum having a locking mechanism according to any of claims 19- 21, and/or a speculum having a lighting module according to any of claims 22-25 in a medical procedure on a , comprising, providing a speculum according to any of the aforementioned ; inserting the speculum into the vagina of a female patient; and performing the medical procedure. WO 17310
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US62/272,616 | 2015-12-29 | ||
US62/281,690 | 2016-01-21 | ||
US62/310,602 | 2016-03-18 |
Publications (1)
Publication Number | Publication Date |
---|---|
NZ743570A true NZ743570A (en) |
Family
ID=
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