U.S. patent number 3,847,143 [Application Number 05/356,178] was granted by the patent office on 1974-11-12 for speculum.
This patent grant is currently assigned to Medspecs, Inc.. Invention is credited to John Cotey, Jean R. Poirier.
United States Patent |
3,847,143 |
Cotey , et al. |
November 12, 1974 |
SPECULUM
Abstract
A speculum is formed of a stiffly flexible plastic material and
comprises two members. Each member has an elongated blade with a
convex outer surface. In one embodiment, the top member is in the
form of an integral hinge with the blade-like portion forming the
front leaf. A pair of assembly pins are attached to the rear leaf
and are adapted to fit into sockets formed in the rear portion of
the lower member. Laterally spaced, arcuate web-like portions on
the bottom member are adapted to engage slots formed in laterally
spaced arms extending rearwardly from the blade portion of the top
member. A handle may be formed on the lower member to facilitate
the use of the device. The two blade-like portions are disposed by
the hinge in side-by-side relationship for pivotal movement of the
two blades about the hinge axis. In another form of the speculum,
the top member has a pair of sockets formed therein adapted to
receive a pair of assembly pins which are integral with the bottom
member of the speculum. A constricted portion is formed in each pin
to form a "living" hinge which permits the operation of the
speculum. In still another embodiment, both blades and the
interconnecting pins are integrally formed of a material having
sufficient flexure to function as a "living" hinge.
Inventors: |
Cotey; John (Haddonfield,
NJ), Poirier; Jean R. (Frederick, MD) |
Assignee: |
Medspecs, Inc. (Frederick,
MD)
|
Family
ID: |
23400456 |
Appl.
No.: |
05/356,178 |
Filed: |
May 1, 1973 |
Current U.S.
Class: |
600/220 |
Current CPC
Class: |
A61B
1/32 (20130101) |
Current International
Class: |
A61B
1/32 (20060101); A61b 001/32 () |
Field of
Search: |
;128/17,20 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Laudenslager; Lucie H.
Attorney, Agent or Firm: Mortenson & Weigel
Claims
What is claimed is:
1. A speculum which facilitates the examination of certain body
passages comprising:
first and second members each having an elongated blade with a
convex outer surface and a rear portion, and
flexible means for pivotal movement of said blades about said rear
portions between spread and closed positions, said flexible means
being integral with at least one of said members and fixedly
interconnected with the other of said members for disposing said
members in side-by-side relationship.
2. A speculum according to claim 1 wherein said members are
plastic.
3. A speculum according to claim 1 wherein said flexible means
connects said blades together along a pivot axis that is
perpendicular to the movement of said blades.
4. A speculum according to claim 3 wherein said elongated axis has
a physical length approximating the width of said blades, thereby
to reduce yaw in the movement of said blades.
5. A speculum according to claim 1 wherein said flexible means has
an integral linking pin and said other member defines an integral
socket in said rear portion adapted to fixedly receive said linking
pin, thereby to secure said members together.
6. A speculum according to claim 5 which includes:
an arcuate web-like member extending from the rear portion of said
first blade,
latching means having an elongated arm member extending angularly
from the rear portion of said second blade and defining a slot
opening in the direction of said flexible means and adapted to
frictionally engage said web-like member during pivotal movement of
said blades, thereby to releasably maintain the open position of
said blades.
7. A speculum according to claim 1 wherein said flexible means is
integral with each of said members.
8. A speculum according to claim 7 which includes:
latching means having an arcuate web-like member extending from the
rear portion of said second blade and having a toothed edge,
and
an elongated arm member extending angularly from the rear portion
of said first blade and defining a latching protuberance adapted to
engage said edge during pivotal movement of said blades, thereby to
releasably maintain the open position of said blades.
9. A speculum according to claim 8 wherein said members are
plastic.
10. A speculum according to claim 7 which also includes latching
means comprising interengaging parts integral with respective ones
of said blades, and wherein said flexible means interconnects
corresponding sides of said blades.
11. A speculum according to claim 1 which includes:
a pair of laterally spaced, arcuate web-like members extending from
the rear portion of said one blade,
latching means having a pair of laterally spaced arm members
extending angularly from either side of the rear portion of the
other one of said blades and terminating in an integral extension,
each of said arms defining a slot contiguous said integral
extension opening in the direction of said flexible means and
adapted to frictionally engage respective ones of said web-like
members during pivotal movement of said blades, thereby to
releasably maintain the open position of said blades.
12. A speculum according to claim 11 wherein said first member and
said arm members are integral, and said second member and said
web-like members are integral.
13. A speculum according to claim 1 wherein said flexible means is
a linking pin and said other member defines an integral socket
adapted to receive said linking pin, thereby to secure said members
together.
14. A speculum according to claim 13 wherein said socket is located
away from the rear portion of said second member to facilitate
reducing the cross-section of said speculum in the region of said
flexible means when in an open position, thereby to reduce
discomfort caused by the speculum.
15. A speculum which facilitates the examination of certain body
passages comprising:
an integral hinge having a pair of leaves and a pivot axis,
a second member having a rear portion,
one of said leaves and said second member each having an elongated
blade with a convex outer surface, and
the other of said leaves being secured to the rear portion of said
second member to pivotally dispose said blades in side-by-side
relationship for pivotal movement about said hinge.
16. A speculum according to claim 15 wherein said members are
plastic.
17. A speculum according to claim 15 wherein:
said one leaf includes an elongated arm member defining a slot
opening in the direction of the pivot axis, and
said other member includes an arcuate web-like member extending
from the rear portion of said second blade adapted to frictionally
engage said slot during pivotal movement of said blades thereby to
releasably maintain the open position of said blades.
Description
BACKGROUND OF THE INVENTION
This invention relates to an improved speculum which facilitates
the examination of certain body passages and, more particularly, to
a speculum, a portion of which incorporates an integrally formed
hinge.
In the field of gynecology, and for that matter, in the general
practice of medicine, it is often desirable and necessary for the
doctor to examine both visually and with instruments, the interior
of certain body passages. In the case of cancer of the reproductive
organs, for example, 95 percent of all cancer occurs at the cervix.
One of the tests used for the early detection of such cancer is the
so-called "Pap Test" which requires that a vaginal smear be made.
To effect this test the physician must open the vaginal passage or
vault in order to obtain visual access to the cervix. For this
purpose, the physician typically uses one of the many vaginal
speculums that are available today. Most of these speculums are
made of metal and must be washed and sterilized after each use. Due
to excessive vaginal discharge, particularly in women suffering
from an infection, these existing instruments are difficult if not
impossible to thoroughly clean. Particles often remain attached to
the instrument even after washing, cleaning and sterilization. This
tends to leave a doubt in the mind of the doctor and his staff as
to whether or not the instruments are, in fact, cross-infecting the
woman under examination.
Furthermore, the cleaning problem is no small task. Even in the
typical general practioner's office, it is often necessary to make
some 30 or more vaginal smears daily. This requires the stocking of
at least 30 vaginal speculums. After each smear is made, the
speculum must be disassembled, washed and sterilized. This creates
an excessive labor problem not to mention the difficulties
encountered in thoroughly washing the speculums.
To avoid many of these cleaning problems, in recent years many
plastic or disposable speculums have been offered on the market.
Typical of these disposable speculums is one described in U.S. Pat.
No. 3,528,409 issued Sept. 15, 1970, to Samuel M. Bruder. Bruder
uses a pair of pivots and sockets which are snapped together to
provide the pivot necessary to operate the blades of the speculum
in a "duckbill" fashion. Unfortunately, when pivots and sockets of
this type are formed, particularly of plastic, their fit is not
precise and, hence, there is some looseness or "play" between the
tips of the speculum blades. This renders the entire speculum less
than desirable to use.
Accordingly, it is an object of this invention to obviate many of
the disadvantages of the prior art speculums.
Another object of this invention is to provide an improved
disposable speculum that is soundly constructed and has a sure,
precise pivot action.
Still another object of this invention is to provide improved
disposable speculum that facilitates latching the blades in a
spread position.
A further object of this invention is to provide an improved
speculum that can be produced for a relatively low cost.
BRIEF DESCRIPTION OF THE INVENTION
According to a preferred embodiment of this invention, a disposable
speculum includes first and second members each having an elongated
blade with a convex outer surface and a rear portion. One of the
members includes pivot means integral with at least one of the
members disposing said members in a side-by-side relationship for
pivotal movement of the blades about the rear portion between
spread and closed positions. In one form of the invention, the
members are both plastic and the pivot means connects the blades
together along an elongated axis that is perpendicular to the plane
of movement of the blades. In another form of the invention the
members and pivot means are integral.
In still another form of the invention, the pivot means has a
linking pin that is adapted to engage a socket in the rear portion
of the second member adapted to receive the linking pin. With the
two members thus fixedly joined together by the linking pin and by
the use of a pivot means that is integral with the first blade,
little or no sidewise movement or "yaw" of the blades is permitted.
Rather, the blades pivot only within their plane of movement and
the resulting speculum is a relatively stable, sturdy unit.
Alternatively, the pivotal movement may occur by flexing the pins
themselves.
The blades may be latched by forming an elongated arm member
extending angularly from the rear portion of the blade which
defines a slot opening in the direction of the pivot means. Next an
arcuate web-like portion is formed at the rear of the second blade
and is adapted to frictionally engage the slot during pivotal
movement of the blades. This permits the friction between the slot
and the arcuate member to releasably secure the blades in an open
position. Alternatively, latching may be accomplished by forming a
locking protuberance on the arm member that is adapted to engage
teeth formed in the web-like portion. The speculum may be unlatched
by flexing the arm member to disengage the teeth.
BRIEF DESCRIPTION OF THE DRAWINGS
The novel features that are considered characteristic of this
invention are set forth with particularity in the appended claims.
The invention, itself, however, both as to its organization and
method of operation, as well as additional objects and advantages
thereof will be best understood from the following description when
read in connection with the accompanying drawings, in which:
FIG. 1 is a pictorial view of a speculum in closed position
constructed in accordance with this invention;
FIG. 2 is a side elevation view of the speculum illustrated in FIG.
1 in a closed position and phantom representation of the speculum
in an open position;
FIG. 3 is a top plan view of the speculum illustrated in FIG.
1;
FIG. 4 is a front elevation view of the speculum illustrated in
FIG. 1;
FIG. 5 is a rear elevation view of the speculum illustrated in FIG.
1;
FIG. 6 is a fragmentary exploded view of the pin and socket portion
of the speculum illustrated in FIG. 1;
FIG. 7 is a fragmentary side elevation view of a speculum
constructed in accordance with another embodiment of this
invention, the speculum being illustrated in a closed position;
FIG. 8 is a fragmentary top plan view of the speculum illustrated
in FIG. 7;
FIG. 9 is a fragmentary exploded side view of the pin and socket
portion of the speculum illustrated in FIG. 7 particularly
depicting the living hinge that is provided by the pin;
FIG. 10 is a side elevation view of a single piece speculum formed
in accordance with still another embodiment of this invention;
FIG. 11 is a top plan view of the speculum illustrated in FIG. 10;
and
FIG. 12 is a rear elevation view of the speculum illustrated in
FIG. 10.
DESCRIPTION OF THE PREFERRED EMBODIMENT
As can be seen most clearly in FIGS. 1 through 5, the speculum
constructed according to this invention is formed preferably of two
separate members, a first member 10 and a second member 12. The
first or upper member 10 includes an elongated blade 14 having at
the rear portion thereof a hinge or pivot 16 integrally formed with
the blade. The hinge or pivot 16 has a rear leaf 18 (the front leaf
being formed by the blade 14) and pivots about an axis 17.
Extending angularly downwardly (in the drawing) from the rear
portion of the upper blade 14 are a pair of laterally spaced arms
20 which are integrally connected together as at 22 at the rear
portion thereof thereby to form a thumb rest 24. The thumb rest 24
may have a knurled surface. On either arm 20 contiguous the
integral rear portion 22 are a pair of slots 26 lying in a vertical
plane and opening in the direction of the axis 17 of the hinge
16.
Secured to the lower portion of the rear leaf 18 of the hinge are a
pair of assembly pins 30 (FIGS. 2 and 6) which in this embodiment
may be cylindrical in form. These pins are adapted to engage
respective sockets 32 formed in tubular bosses 34 in the rear
portion of a second member 12. The second member 12 has at the
forward end a blade portion 36. Each of the blades 14 and 36 are
generally hollow and shell-like to provide a convex exterior of the
required shape for the purpose intended. Typically, also, the upper
blade 14 may be shorter in length than the lower blade 36 such that
it may fit into the lower blade 36 when the speculum is in a closed
position. This shortened blade 14 is the design typically used for
conventional vaginal speculums.
Arcuate web-like members 38 are formed in generally parallel
relationship on either side of the rear portion of the second
member 12 and are so aligned that their peripheries are adapted to
frictionally engage the slots 26 in the thumb rest 24. When the
two-piece speculum is assembled by inserting the assembly pins 30
into the sockets 32, as will be described hereinafter, and the
thumb rest 24 is depressed, the blades 14 and 36 open in a duckbill
fashion. To complete the speculum, a handle having a U-shaped
cross-section is formed extending downwardly (in the drawing -- 40)
from the rear portion of the second member 12 and the arcuate
web-like members 38. It may be noted that both the first and second
members are formed to have a relatively constant thickness.
Preferably, they are formed of individual pieces of stiffly
flexible plastic material such as polyamid sold under the tradename
"Nylon," a polytetrafluoroethylene sold under the trademark
"TEFLON," or perhaps most preferably, a polypropylene plastic may
be used. Whatever the plastic, they are molded in suitable molds
according to known techniques to have the desired constant
thickness and shape. When formed of a plastic material as
described, the hinge, being integral with one of the blades,
functions by bending the material of which it is formed. A hinge of
this type is often referred to as a "living hinge."
Preferably, multiple capillary sized water retention dimples or
holes 42 may be formed on the front and forward portions of the
blades. This aids in lubricating the speculum for ease of
penetration into the vaginal tract. The use of other lubricating
preparations tends to interfere with the accuracy of the Pap
Test.
As noted hereinbefore, the hinge 16 preferably is formed integrally
with the first member 10 and is formed during the molding or
fabrication to have a relatively thin wall thickness dimension or
groove as seen most clearly at 42. In this manner, the plastic
which is stiffly flexible to begin with, can be more easily flexed
along the groove 40 which provides the axis 17. Preferably, the
hinge has a length corresponding approximately to the width of the
top blade. The hinge, being continuous, prevents the two blades
from undergoing any significant sidewise movement, usually termed
"yaw," as is a characteristic problem of many of the plastic
speculums on the market today.
To manufacture the speculum, the assembly pins 30 are formed to
have a diameter slightly greater than the diameter of the sockets
32. As the two members 10 and 12 are removed from their molds, they
are immediately, while still hot, assembled by forcibly inserting
the assembly pins 30 into the sockets 32. Thus, as the cooling
takes place, the sockets 32 which are normally enlarged because of
the heat, contract as they cool thereby forming a tight, secure
interlock whereby the two members 10, 12 are now rigidly and
fixedly secured together. Alternatively, of course, the pins and
sockets may be secured as by a suitable cement or other
material.
It may be noted that the arc of the arcuate members has a radius,
with respect to the axis 17 of the hinge 16, which is approximately
the same as the radius of the slots 26 with respect to the same
axis 17. The integral hinge utilized in this speculum is capable of
many flexures over an extended period of time without the plastic
material fatiguing or breaking.
In use, the physician or operator need only grasp the handle 40 in
either hand and with the blades 14 and 36 in a closed position as
illustrated in FIG. 1 and in FIG. 2 by phantom lines, introduce the
speculum into the body cavity in a conventional manner. To open the
cavity for better visual access, he places his thumb upon the thumb
rest 24 and presses the thumb rest downwardly. This causes the
upper blade 14 to pivot about the axis 17 of the hinge 16 thereby
pivoting the upper blade 14 upwardly in the drawing. As the opening
continues, the slots 26 frictionally engage the arc-like web member
38 such that when the physician ceases to apply further force to
the thumb rest, the blades are latched in an open position. After
the examination is completed, or the smear taken in the case of a
vaginal smear, the thumb rest may be raised to again close the
blades and the speculum withdrawn. To aid in the initial insertion,
the tip of the speculum may be moistened with water which tends to
collect in the water retention dimples 52 in the front portion of
the blades.
It is to be understood that essential roles of the two members may
be reversed and the integral hinge formed in the lower member.
Also, the hinge may be separately formed of plastic or other
material and secured to the blade, although the integral hinge is
preferred for reasons of ease of manufacture, cost and superiority
of operation.
In an alternative embodiment of the invention, depicted
particularly in FIGS. 7 through 9, a speculum may be constructed
similarly to that previously described. The difference in this case
is the hinge mechanism. In the embodiment of FIGS. 7 through 9,
pins 44 are secured to the upper portions of each of the web-like
members 38 of the bottom member 12. These pins 44 are integrally
formed with the member 12 and have a constricted portion 46 which
is transverse to the axis of the pin to facilitate the bending or
living hinge action of the pin. In the alternative, of course, the
pins themselves being slightly flexible, particularly when formed
of plastic, may be used to provide the hinge action.
The pins 44 are adapted to engage sockets 50 formed in bosses 48
formed on the lower side of the upper member 10. The particular
location of the pins 44 and the sockets 50 on the speculum is
optional. In many cases it may be desirable that they be located
well forward of the handle 40 and away from the rear portion of the
speculum. This location permits the cross-sectional area of the
speculum, when in an open position, to be as small as possible.
This small cross-sectional area often is desirable, since when used
as a vaginal speculum, this is the portion of the speculum which is
at the lip of the vagina. This is the most sensitive part of the
vagina and often causes discomfort to the patients under
examination. The same friction lock previously described in FIGS. 1
through 6 is useful with this embodiment as is seen most easily in
FIG. 8. The manufacture of this speculum is accomplished in the
manner described above. The pins and socket may be assembled either
while the materials are hot, immediately after molding, or they may
be secured by suitable cement or other material.
The important advantages offered by the speculum of this invention
are provided by the "living" hinge in that it provides a great
stability to the operation. Also, the small cross-sectional area at
the hinge point is advantageous. The speculum has a positive action
and little tendency for the blades to slip or to disengage as is
often the case with speculums that are presently available. The
speculum is a relatively stable, simple, low-cost disposable
speculum which is free of the normal yaw problems often encountered
in disposable speculums. The speculum is easy to use and permits
good visual access to the interior of body cavities.
A still further alternative embodiment of the invention is
illustrated in FIGS. 10 and 11 in which there is shown a speculum
formed of a single piece of material, i.e., such that the speculum
is an integral unit. This speculum may be constructed in
substantially the same manner, e.g., by molding, as those
illustrated in the preceding figures. Alternatively, the two blades
10' and 12' may not be contoured and may be straight such as to
have a substantially constant cross-section, if desired. This
constant cross-section or width of the blades facilitates molding
of the unitary speculum. Alternatively, they may be tapered, if
desired, toward the tips. In this embodiment the two blades 10' and
12' are connected by pivot means or a pair of "living" hinges 70
which are integrally formed and join the two blades. The width of
the living hinge 70 is smaller, preferably less than 1/4 inch
measured along the axis of the blade, to permit the necessary
flexure of the material forming the blades. The same material as
previously described may be used, i.e., one of the plastics is
preferred.
The lower blade 12' is integrally connected with a downwardly
extending handle 40 which has a U-shaped cross-section as
previously described. Furthermore, one side, preferably the right
side as viewed from the rear, of the lower blade 12' has a
rearwardly extending, arcuate web-like flange 72, the arcuate edge
of which has teeth 74 formed therein. These teeth 74 are adapted to
engage a locking member or protuberance 76 formed in the side of a
rearwardly extending arm 78 which is integrally formed with the
right side (as viewed from the rear) of the top blade 10'. The
extreme end portion of the arm 78 has a thumb rest 80 formed
therewith to facilitate its use.
In use the speculum is inserted into the body cavity and with the
physician's hand gripping the handle 40, he depresses the thumb
rest 80 causing the blades 10' and 12' to open. The material
forming the hinges 70 flexes to provide the hinge-like action. As
the blades open, the latching protuberance 76 engages the teeth 74
such that the speculum remains latched in a desired open location
during the examination. When it is desired to withdraw the
speculum, the physician merely need press the arm 78 outwardly
thereby disengaging the protuberance 76 from the teeth 74, and the
speculum immediately snaps closed. It will be noted that the
pivoting of the speculum occurs along the center points of the
material forming the living hinge 70, the pivot axis being depicted
by the dash-dot line 82.
Since the blades 10' and 12' are joined by the same material of
which they themselves are formed, which joining material forms the
hinge 70, the two blades are held firmly in their relative
positions and little sidewise movement or yaw is permitted during
operation. Furthermore, it may be noted that the center line 82 of
the pivot action of the speculum is well forward of the rear
portion of the blades. This permits, particularly in the
examination of the vaginal orifice, for the blade opening to occur
within the lips of the vagina thereby reducing the discomfort to
the patient as previously noted. Another advantage accrued from the
unitary speculum is its low cost of production since no labor,
other than molding which is an automated operation, is required in
assembling the speculum -- the speculum is completely formed in the
mold itself.
It is obvious that many embodiments may be made of this inventive
concept, and that many modifications may be made in the embodiments
hereinbefore described. Therefore, it is to be understood that all
descriptive material herein is to be interpreted merely as
illustrative, exemplarly and not in a limited sense. It is intended
that various modifications which might readily suggest themselves
to those skilled in the art be covered by the following claims as
far as the prior art permits.
* * * * *