U.S. patent number 3,815,585 [Application Number 05/340,208] was granted by the patent office on 1974-06-11 for disposable vaginal speculum.
This patent grant is currently assigned to Bio-Analytical Laboratories, Inc.. Invention is credited to John M. Fiore.
United States Patent |
3,815,585 |
Fiore |
June 11, 1974 |
DISPOSABLE VAGINAL SPECULUM
Abstract
A vaginal speculum instrument comprising a pair of molded
synthetic resin frame members each of which includes or defines a
duckbill at one end thereof. Interconnection of the pair of frame
members is provided by means of a sliding interfit relationship
which provides duckbill mating, and adjustable parallel separation
of one duckbill with respect to the other. A flexible hinge section
at the base of one duckbill permits the duckbill not only to be
angularly rotated with respect to the other duckbill, but also to
provide further duckbill opening in one direction.
Inventors: |
Fiore; John M. (Troy, NY) |
Assignee: |
Bio-Analytical Laboratories,
Inc. (Troy, NY)
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Family
ID: |
26803574 |
Appl.
No.: |
05/340,208 |
Filed: |
March 12, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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106346 |
Jan 14, 1971 |
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Current U.S.
Class: |
600/222 |
Current CPC
Class: |
A61B
1/32 (20130101) |
Current International
Class: |
A61B
1/32 (20060101); A61b 001/32 () |
Field of
Search: |
;128/17,18,19
;220/31S |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
advertisement of Welch Allyn, Inc., In Medical-Surgical Research,
Feb. 1970, page 35..
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Primary Examiner: Laudenslager; Lucie H.
Attorney, Agent or Firm: Lichiello; James J.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This invention is a continuation-in-part application of copending
application Ser. No. 106,346 filed Jan. 14, 1971 -- Fiore assigned
to the same assignee as the present invention, now abandoned.
Claims
What I claim as new and desire to secure by Letters Patent of the
United States is:
1. A single use disposable vaginal speculum comprising in
combination
a. first and second synthetic resin frame members,
b. a duckbill part on each of said frame members,
c. adjusting means joining said frame members so that upper and
lower duckbills are defined which may be adjustably separated and
engaged in parallel relationship,
d. a flexible hinge section joining said upper duckbill part to
said second frame member,
e. and lever means on said second frame member to flex said
flexible hinge sections so that said upper duckbill part is
angularly rotated with respect to said second frame member by
flexing said flexible hinge section.
2. The invention as recited in claim 1 wherein said flexible hinge
is integral with both said duckbill part and said second frame
member.
3. The invention as recited in claim 1 wherein said flexible hinge
is integral with said frame member and joined to said duckbill
part.
4. The invention as recited in claim 1 wherein said flexible hinge
is biased to position said duckbills in a predetermined
position.
5. The invention as recited in claim 1 wherein said flexible hinge
section provides a dual hinge action of said upper duckbill with
respect to said second frame member.
6. The invention as recited in claim 1 wherein a spaced pair of
said flexible hinge sections join said upper duckbill part to said
second frame member in angular relationship.
7. The invention as recited in claim 1 including locking means on
said handle means to engage said lever means to lock said upper
duckbill in position.
8. The invention as recited in claim 7 wherein said lever means
comprises a flap member having a series of apertures therein, and
said second frame member includes a pin adapted to be inserted into
one of said apertures to provide locking means.
9. The invention as recited in claim 7 wherein said locking means
is a self-locking biasing means engaging said lever means.
10. A single use disposable vaginal speculum of a synthetic resin
material comprising in combination
a. a first frame member forming a hollow handle part and a lower
duckbill part,
b. a means frame member forming an elongated adjusting section and
an upper duckbill part,
c. said elongated adjusting section being positioned in sliding
coaxial relationship in said hollow handle part so that said
duckbills meet in engaging relationship,
d. integral flexible hinge means in said second frame member to
provide angular rotation of said upper duckbill with respect to
said second frame member.
11. The invention as recited in claim 10 wherein
a. one of said hollow handle part and said adjusting section
defines a series of apertures therein,
b. a lock projection on the other of said handle part and said
adjusting section,
c. and biasing means to engage said lock projection with one of
said apertures to lock the relative position of said frame
members.
12. The invention as recited in claim 11 wherein said handle
portion defines said apertures and said adjusting section defines
said lock projection.
13. The invention as recited in claim 12 wherein a separate member
in said adjusting section is provided with said lock projection,
and fulcrum means in said adjusting section to support said
separate member for oscillating motion.
14. The invention as recited in claim 12 wherein said biasing means
defines a notch portion in one of said members so that a part of
said member can be flexed about said notched portion.
15. A vaginal speculum comprising in combination
a. a first synthetic resin frame member defining a U section and an
elongated handle section depending therefrom,
b. a second synthetic resin frame member defining a U section and
an elongated adjusting section depending therefrom,
c. said sections being adapted to be telescopically interfitted in
sliding register relationship,
d. lower duckbill means extending angularly from said first frame
member,
e. upper duckbill means extending angularly from said second frame
member,
f. a thumb lock depressent means on said second frame member for
disengaging lock projection means between said frame members for
relative sliding relationship thereof,
g. integral hinge means comprising oppositely disposed notched
portions in the U section of said second frame member to permit
dual angular adjustment of said upper duckbill,
h. lever eans extending from said upper duckbill, and
i. lock means extending from said U section of said second frame
member to adjustably interlock with said lever to adjust the upper
duckbill in angular relationship with respect to said lower
duckbill.
16. The invention as recited in claim 10 wherein said second frame
member comprises
a. a yoke member having a pair of upstanding arms,
b. said integral flexible hinge means comprising a flexible hinge
section integral with an end of each of said arms,
c. snap fastener means on the end of each of said flexible hinge
sections,
d. said upper duckbill part having snap fastener apertures therein
into which said snap fastener means project to join said upper
duckbill part to said yoke member,
e. a separate lock member in said elongated adjusting section,
f. fulcrum means in said elongated adjusting section to support
said lock member for oscillating motion,
g. and a lock projection on said lock member adapted to project
into openings in a distal wall of said first frame member.
17. The invention as recited in claim 10 wherein
a. a laterally projecting pin member projects from said elongated
adjusting section,
b. a laterally flexible flap member extends from said upper
duckbill part,
c. said flap member having a series of apertures therein,
d. said integral flexible hinge means permitting said apertures to
be aligned with said pin member so that said flap member can be
laterally flexed and said pin member caused to enter one of said
apertures thereby locking said upper duckbill part in angular
relationship to said elongated adjusting section.
Description
BACKGROUND OF THE INVENTION
This invention relates to a vaginal speculum instrument and more
particularly to an improved single use disposable vaginal speculum
instrument molded from a synthetic resin material.
A vaginal speculum is an important medical instrument which serves
as an expedient means for providing examination and treatment of
the vagina and related areas. Examples of this relatively old
instrument are found in U.S. Pat. Nos. 662,830 and 2,672,859.
A vaginal speculum comprises, briefly, a composite frame assembly
having a pair of protruding mating and adjustable duckbills which,
in their engaged position, are inserted into the vagina, and
thereafter separated or opened to provide a channel for visual
examination and treatment.
In general, the prior vaginal specula of the kind noted were
usually made of permanent or semipermanent material such as metal,
and were not economically single use disposable items. After each
use the instruments were required to be cleaned and sterilized,
before any further use, as a medical necessity to prevent transfer
of harmful bacteria from one patient to another, or from any source
of contamination to the patient. Such cleaning practices are time
consuming as well as undesirable and menial tasks. At the same time
these practices tend to limit the number of vaginal examinations
which may be accomplished in any given time period unless a greater
number of these instruments are immediately available. The number
of vaginal examinations being performed have been drastically
increasing in all areas of medical diagnosis and treatment, such
examination becoming commonplace not only as a part of other
examination procedures, but also as a regular and recommended
practice for preventative medicine. In clinics, hospitals, and
other associations the increased number of such examinations
performed are not being adequately met by more expedient medical
instruments.
Medical practitioners require a vaginal speculum which lends itself
to manual dexterity. Prior specula of a permanent nature included
sufficient moveable parts not only to provide a smooth parallel
adjustment of the duckbills, but also angular adjustment of the
duckbills over a wide range of separation. An important control
feature of the prior specula is smooth angular adjustment at
maximum duckbill separation as well as at intermediate positions.
In a given degree of parallel separation of the duckbills, the
availability of wider angular adjustment is an advantageous control
feature. Also prior vaginal specula could be adjusted so that
starting with parallel separation of the duckbills, the duckbills
could be angularly adjusted so that their distal ends could be
engaged. This dual angular adjustment, i.e. angular adjustment of a
duckbill above and below a horizontal or parallel relationship, is
an important advantage in the mechanics of ease of inserting the
vaginal speculum and adjustment thereafter.
It has been discovered that a single use disposable vaginal
speculum may be conveniently molded from certain synthetic resin
materials not only to have all the control features of existing
permanent instruments, but also to be readily and economically
permanently disposable after being used once. The described vaginal
speculum may require only two parts, a design which contributes to
its economic disposability but at the same time expeditiously
incorporates self locking features therein.
OBJECTS OF THE INVENTION
Accordingly, it is an object of this invention to provide an
improved single use disposable vaginal speculum.
It is a further object of this invention to provide dual angular
adjustment of a duckbill in a single use vaginal speculum.
It is a still further object of this invention to provide a plastic
single use disposable speculum having a flexible hinge section at
the base of one duckbill for angular adjustment thereof.
It is another object of this invention to provide an improved snap
fastener flexible hinge for a duckbill in a plastic single use
disposable speculum.
It is a yet further object of this invention to provide a two piece
single use disposable vaginal speculum having a self locking
arrangement for duckbill parallel separation, and a duckbill
flexible hinge section for dual angular adjustment thereof.
SUMMARY OF THE INVENTION
Briefly described, a preferred form of this invention includes a
vaginal speculum instrument manufactured from a single use
disposable synthetic resin material. The speculum comprises a pair
of frame members each of which defines a duckbill at one end
thereof. Sliding interconnection of these frame members provides
mutual engagement and separation of the duckbills. An integral or
flexible hinge section in one of the duckbills provides angular
adjustment control thereof while a positive lock means locks the
duckbills in a predetermined separated position. During
utilization, the forces to which the duckbills are exposed tending
to cause the duckbills to move together are effectively employed in
the lock means to automatically make the lock means more
positive.
This invention will be better understood when taken in connection
with the following drawing in which
FIG. 1 is an isometric view of a preferred operative embodiment of
this invention.
FIG. 2 is an elevational view of the upper duckbill and sliding
frame assembly of FIG. 1.
FIG. 3 is a front elevational view of a modified sliding frame or
yoke of FIG. 2.
FIG. 4 is a side elevational view of the modified sliding frame of
FIG. 3.
FIG. 5 is an illustration of an upper duckbill section for the
frame of FIGS. 3 and 4.
FIG. 6 is a front elevational and assembly view of the modified
vaginal speculum of FIGS. 3, 4 and 5.
FIG. 7 is a side elevational view of the vaginal speculum of FIG.
6.
PREFERRED EMBODIMENTS OF THE INVENTION
The present invention is more specifically related to a single use
disposable vaginal speculum although the invention may also be
produced in those materials considered as permanent materials, for
example, metal. While various materials may serve as single use
disposable materials including synthetic resin materials,
cellulosic materials and others, synthetic resins are preferred
materials. A particular class of synthetic resins known as the
polyolefins have excellent characteristics for the manufacture of
this invention. A preferred member of this class of resins is
polypropylene resin. Polypropylene resin has exceptional molding
characteristics for molding in complete shapes wherein it retains
its structural integrity.
More particularly, polypropylene has been found to be non-toxic
with respect to body tissues and fluids and also to have a
favorable degree of resilience which under overstress conditions
permits gradual deformation without fracture. Resiliency is an
important feature because materials which are brittle and tend to
fracture with sharp edges are to be avoided.
In addition, polypropylene resin may incorporate a number of color
additives so that the instrument may not only have a pleasing
color, but also will have a texture or opacity which will not
interfere with visual examination.
One preferred embodiment of this invention is illustrated by the
speculum of FIG. 1. Referring now to FIG. 1, speculum 10 comprises
a pair of interfitting and interconnecting angular frame members 11
and 12. Frame members 11 and 12 are expeditiously assembled to
interfit with one another to provide an integral two part vaginal
speculum having plural adjusting capabilities.
Frame member 11 is described as the first or outer or stationary
member, and includes a handle part 13, a laterally extending first
support structure 14, and an angularly extending duckbill part 15.
Handle part 13 is conveniently of an open or frame structure such
as a hollow box or channel section adapted to receive frame member
12 in sliding relationship therein. Support structure 14 also
includes similar structure portions to receive corresponding parts
of frame member 12 therein.
Frame member 12 is the second and sliding or adjusting member, and
includes an adjusting section 16, a second supporting structure 17,
and a duckbill part 18 which is the mating duckbill for duckbill
part 15. The supporting structure 17 is of a channel or other
section which closely interfits within the corresponding sections
of supporting structure 14. Also the adjusting section 16 slidably
interfits within the handle part 13. The mutual engagement of these
parts and structures provides maximum structural integrity of the
instrument throughout its adjusting range.
Frame members 11 and 12 are each expeditiously molded in a single
piece construction in such form that they provide elevational and
angular adjustment of the duckbills together with a positive
locking and adjusting mechanism for each. Each frame member is
therefore provided with details of construction which cooperatively
relate to the other to provide these features.
The handle part 13 of frame member 11 includes a front surface 19
containing a ladder-like arrangement of slot-like apertures 20
therein, and a cutaway aperture 21 thereabove. At the upper
extremity of aperture 21 the support section 14 is generally of a
U-shape with laterally extending shoulder members 22 and 23 and
upstanding arms 24 and 25. Arms 24 and 25 are generally described
as inwardly facing channel sections defining a closed back wall 26.
This closed back wall 26 is conveniently tapered or flared into the
duckbill 15 and serves to provide structural rigidity for duckbill
15.
Referring now to FIG. 2, the adjustable section 16 of frame member
12 is also conveniently formed as a box or channel section to
slidably fit into handle part 13. Section 16 also includes opposite
U or notch openings 27 in the side walls of the channel section so
that the lower part thereof may be resiliently flexed or pivoted
about the apex of the notched section. To aid in this flexure a
thumb stop or raised portion 28 is provided at the notch section to
define an area where an applied force easily pivots the lower part
of section 16 about the notch portion. The lower part of section 16
also includes a locking projection 29 which is adapted to fit with
the slots 20 of handle part 13.
For example, as noted in FIG. 1, section 16 slides into handle part
13, and its lock projection 29 projects into one of the slots 20 to
lock section 16 in handle part 13. Handle part 13 may be a channel
section, and thus not have a rear wall, or it may be a box section
with a part of the rear wall removed. In either event the structure
would provide the space necessary for sufficient rearward flexure
of the lower part of section 16, so that lock projection 29 is
moved out of the slots 20, and section 16 is thus raised or lowered
to a desired position. The adjustment operation is conveniently
carried out by thumb pressure on the thumb stop 28 to flex the
lower part of 16. The aperture 21 provides sufficient clearance for
thumb stop 28 to be raised or lowered the desired amount.
The instrument is easily adjusted with the same hand which holds
the instrument before or after insertion. The thumb stop 28 is
depressed and section 16 is moved upwardly for projection 29 to
engage an upper slot 20. In this operation supporting part 17 which
defines a visual and treating aperture through instrument 10 is
elevated significantly above the lower duckbill 15, and an enlarged
apertured channel is defined through the duckbills.
A most important feature of this one hand adjustment operation is
the self-locking feature of the lock projection 29 and slot 20
arrangement. Ordinarily during its operative function, the vaginal
speculum 10 is subjected to forces tending to constrict the
duckbills, i.e. tending to force them laterally together. This
force is in opposition to the elevational adjustment described.
However, these forces tend to pivot each frame member oppositely so
that handle part 13 tends to pivot forwardly, and sliding member 16
rearwardly. Consequently the lock projection 29 is caused to move
more tightly into engagement with slot 20 to provide more of a
self-locking feature.
Lock projection 29 slopes outwardly and downwardly, as more clearly
shown in FIG. 2, and thus fixes itself in slot 20 as a result of
the downwardly component of forces on the duckbills. There is thus
provided a self-locking non-slip vaginal speculum which will not
suddenly collapse or slip out of adjustment during insertion or
examination manipulations.
The elevational locking arrangement as above described may be
easily reversed so that the slot openings are in a wall of section
16 and lock projection 29 projects inwardly from wall 19. Other
self-locking arrangements utilizing the exerted forces from the
duckbills may also be gainfully employed in this invention.
The supporting section 17 is also generally of a U-shape
construction with a tang member 30 and a pair of upwardly extending
arm members 31 and 32. While these members may be box sections,
they are preferably channel sections with no rear wall. Section 17
is slidably mounted in section 14 so that an easy sliding
relationship is provided in which the interfitting wide stance
arrangement is well braced for structural integrity.
The supporting section 17 defines a framed aperture by means of the
upper duckbill 18 bridging the arm members 31 and 32. The aperture
is transverse to the longitudinal axis of the duckbills and is of
generous dimension. It is through this defined aperture that the
practitioner carries on his examination and treatment. Other
instruments and devices which are employed in conjunction with a
vaginal speculum are conveniently inserted and withdrawn through
this aperture.
It is most important to have duckbill angular adjustment means
associated with one of the duckbills and preferably the upper
duckbill 18. A very great advantage and overall simplicity of
design and manufacture is attained if the adjusting means does not
involve extra parts nor separates a one piece frame member. This
advantage is achieved in this invention by the use of a flexible
hinge section utilizing the material and structure of frame member
12.
In frame member 12, the duckbill 18 bridges the arms 31 and 32 and
forms therewith a pair of flexible hinge sections 33. The hinge
sections 33 are best described as a hinged section for or in each
arm member 31 and 32 and are formed by a pair of shoulder members
34, one on each side of duckbill 18 integrally joining the duckbill
to a respective arm member 31 and 32. The shoulders 34 are of
rectangular cross section at their juncture with the channel shaped
arm members 31 and 32. A respective arm and shoulder is therefore
described as a single member of elongated rectangular cross
section, formed or folded to define a shoulder and arm position
having their longitudinal axis in perpendicular relationship. In
order to provide this juncture with the freedom of a flexing hinge
action, while at the same time providing a single piece stable
construction, there is a removed notch or V section 35 so that the
actual juncture takes place along essentially only the back wall at
36 of the arm members 31 and 32. Since in effect the channel or
rectangular members 31 and 32 are connected together by only a flat
wall portion, this portion is easily flexed without breakage while
providing strong engagement and rigidity of the structure. Equally
important is the fact that the notch section is sufficiently large
to provide a dual angular adjustment, i.e. above and below the
horizontal line of the duckbills. For example, at a given parallel
separation of the duckbills, the upper duckbill may be angularly
directed downwardly so that its distal end touches the distal end
of duckbill 15. It is in this position that the speculum is most
expeditiously inserted and thereafter adjusted. In the embodiment
as shown the hinge sections are formed with the frame member. They
are in effect integral with the frame member and not separate or
discrete parts which are affixed to or joined to the frame member.
This means that the frame members can be molded in a single piece
design. Also the entire hinge action takes place solely by the
flexure of the material of sections 33.
As can be seen in FIG. 1 particularly, the distal end of duckbill
18 may be elevated or rotated counterclockwise about the flexible
hinge section 33 to angularly adjust duckbill 18 with respect to
duckbill 15. It is highly desirable that this adjustment be
adaptable for operation by the practitioner with minimum effort and
with the same hand or fingers which hold the instrument and operate
thumb stop 28. At the same time some provision is necessary to lock
the duckbills in an angular relationship. This angular operation
and lock arrangement is accomplished by means of ratchet lever 37
engaging a locking platform 38.
In FIG. 1 ratchet lever 37 is shown to be an integral part of the
upper duckbill 18 and commences from a shoulder member 34 to define
a wedge shape with a toothed edge surface 39. FIG. 2 shows, more
precisely, the construction whereby the ratchet lever 37 extends
from a shoulder member 34. Lever 37 is conveniently formed with a
thumb surface 40 so that when depressed, the duckbill 18 is rotated
about the two hinge sections 33 for angular adjustment. Also formed
integral with supportion section 17 is a locking platform 38 which
flares horizontally outwardly from section 17 and includes a part
41 which curves in front of toothed surface 39 as more clearly
shown in FIG. 2. In FIG. 2 the part 41 is formed with an upwardly
tapered, edged, front surface 42 which engages the toothed surface
39 of ratchet lever 37. The shape and cantilever construction of
platform 38 are correlated so that it may be easily flexed
downwardly to the point that the toothed surface 39 is freed from
the edged surface 42.
In the operation of the angular locking device a slight but firm
thumb pressure on surface 40 causes the platform 38 to be flexed
downwardly until the toothed surface 39 of lever 37 slips or
ratchets over the edge surface 42 of platform 38. At the same time
duckbill 18 is caused to angularly rotate upwardly about the
flexible hinge sections 33. When the desired angular position is
reached, a relaxation of the applied force on surface 40 permits
platform 38 to unflex or rise upwardly so that its edge surface 42
firmly engages the teeth of toothed surface 39 and locks the
duckbill 18 in position. As can be best seen in FIG. 2, the slope
angle of the tooth surface 39, as well as the teeth thereon, with
respect to edge surface 42 is calculated to provide expedient
ratcheting and slippage in the downward direction, e.g. upward
rotation of duckbill 18, but locking in the upward direction. Also,
the platform 38 is shaped or structurally braced to provide more
resiliency in the downward direction than in the upward direction.
Therefore, there is a positive lock means for the angular
adjustment of duckbill 18. Any force tending to cause the duckbill
18 to close with duckbill 15 causes the lock means to become more
positively engaged. To disengage the lock means, a slight downward
thumb pressure on the outer end 41 of platform 38 causes platform
38 to flex downwardly and disengage the toothed surface 39 from
edge surface 42 so that duckbill 18 is free to be rotated
downwardly.
Note, for example, that the upper duckbill 18 (frame member 16) may
be easily adjusted upwardly for parallel duckbill separation. In
this position, or even in the maximum duckbill separation position,
by means of the angular locking and adjusting means 37 and 38, the
duckbill 18 may be further angularly rotated upwardly. More
importantly, the duckbill 18 may be angularly adjusted so that its
distal end touches the distal end of duckbill 15 while the frame
member 16 is in an upward adjusted position. The latter adjustment
forms somewhat of a triangular shape which is much desired for
instrument insertion. In one respect, after insertion, it is often
much easier to angularly adjust duckbill 18 upwardly rather than to
raise frame member 16. This is particularly true with prior art
permanent instruments which have this dual adjusting feature
provided by other structural means. The triangular position of this
invention is made possible through the flexible hinge sections 33
which also provide for the one piece frame 16 construction.
Each of the foregoing locking and adjusting arrangements, both
elevational and angular, are exemplary of a number of such locking
and releasing arrangements which may be expeditiously employed in
this invention. The disclosed arrangements offer convenience of
location and ease of adjustability by a one hand manipulation. Both
locking arrangements are disposed in series, i.e. the forces
tending to close the duckbills are resisted by both locking means.
Consequently, it is desirable to provide each with quivalent
locking strength so that each will be able to withstand maximum
stress.
One outstanding advantage of the vaginal speculum instrument of
this invention is that it may be molded as a simple two piece
construction which provides all the desirable motions of the prior
metal instruments. In all of the adjustments there is no scissor
action of frame member parts in the handle portions.
This invention thus provides an improved one hand adjustable single
use disposable vaginal speculum having all the required features of
the prior non-disposable or permanent vaginal speculums. At the
same time this invention provides those features in a two piece
device wherein an integral flexible hinge provides angular
adjustment of an upper duckbill.
The flexible hinge section need not be integral with the entire
frame member as it is in FIGS. 1 and 2, but also may serve to
connect two parts of a frame member although the flexible hinge
action is still confined to a hinge section which is formed in the
material of the frame member part and is integral with that part.
For example, in FIG. 3 there is shown a modified yoke or frame part
43 which is similar to part 12 of FIG. 2 without the duckbill part
18 and lever 37. Frame part 43 includes two flexible hinge sections
44. Each hinge section 44 is formed as an integral part of the
frame part 43, that is, each part 43 is formed so that the flexible
hinge section 44 or part that flexes to provide the hinge action,
is integral therewith. The important concept is not so much whether
the hinge section 44 is integral with two or more other parts, but
that the entire hinge action is derived through the flexibility of
a section of material. No moving parts make up the hinge and there
is no pin or bearing relationship. Each hinge section 44 comprises
a reduced or flattened wall part 45. As more clearly shown in FIG.
4 the flattened wall part 45 is a ribbon strip or convolute wall
formed to provide increased flexibility for hinge purposes. The
flattened wall part terminates in a snap fastener 46 which is
employed to join a duckbill section to the frame 43. Each snap
fastener 46 comprises an enlarged head part 47 with a tapered front
48, and a neck part 49. The head and neck parts are divided by a
kerf-like slot 50 so that the defined two sections can be
compressed to a smaller diameter. Each snap fastener 46 is
supported from a bearing support 51.
In FIG. 5 the duckbill section 52 is a single piece with
appropriate apertures which receive the snap fasteners 46 to lock
the two parts as a unitary frame member. However, the flexible
hinge sections 44 operate substantially as described for the hinge
sections 33 of FIGS. 1 and 2. In FIG. 5, a single piece upper
duckbill section 52 comprises a duckbill 53 and a lever assembly
54. Section 52 also includes a pair of snap lock apertures 55 and
56 (not shown) preferably of square cross-section. These apertures
are merely holes in an appropriate plate part of section 52 and are
coincident with snap fasteners 46 of FIG. 3. To join duckbill
section 52 to yoke 43 of FIG. 3 the apertures 55 and 56 are aligned
with fasteners 46 so that fasteners 46 may project into the
apertures 55 and 56. The fasteners 46 are also preferably of a
square cross section. When the tapered parts 48 progress into
apertures 55 and 56 the snap fasteners are laterally compressed,
because of the slots 50 and pass through apertures 55 and 56 until
the head parts 47 pass all the way through or clear the apertures,
at which point they expand and lock the section 52 to yoke 43.
In this locked position as illustrated in FIG. 7, the snap fastener
square cross section necks 49 fit snugly within the square cross
section apertures 55 and 56 and the square cross section bearing
supports 51 fit snugly in square cross section bearing cavities 57
and 58 (not shown).
This arrangement provides all the expediencies of an integral hinge
while permitting the use of a two piece duckbill sub-assembly where
molding problems need to be ameliorated, particularly with respect
to the particular design desired of the integral hinge. The
convoluted hinge section can easily be biased or pretensioned in
the molding operation so that the duckbills in the not used or
packaged condition take up a predetermined position, e.g.
closed.
A completed speculum including the yoke 43, duckbill 52 and an
appropriate stationary frame 59 is illustrated in FIG. 6. The
modified speculum of FIG. 6 also includes a modified duckbill
elevational locking arrangement 60 and a pin lock form of a
duckbill angular adjusting and locking arrangement.
As noted in FIGS. 3 and 4, the elevational locking arrangement 60
includes a lock member 61 which is formed within the yoke 43 in an
integral molding operation. Lock member 61 can rock or oscillate
back and forth in yoke 43 because it is joined to yoke 43 only by
an intermediate fulcrum or support section 62. In the molding
process lock member 61 is biased so that the bottom lock projection
63 of FIG. 4 projects away from yoke 43 as illustrated. Lock
projection 63 projects into a series of openings in an appropriate
distal wall of frame member 59, FIG. 6. Stationary frame member 59
is similar to stationary frame member 11 of FIG. 1, however, with
the apertures 20 of FIG. 1 being provided in a rear or distal
wall.
The duckbill angular adjusting arrangement is also disclosed in
FIGS. 3 through 7. In FIG. 3, the yoke 43 includes a laterally
projecting pin member 64 and the lever arrangement 54 of FIG. 6
includes a series of openings 65 therein. As more clearly
illustrated in FIG. 6, the lever arrangement comprises a thumb
depressor 66 and a flexible flap 67 in which openings 65 are
located. It can be seen from FIG. 6 that flap 67 can be flexed
laterally, by the same thumb used to depress thumb depressor 66, to
disengage pin 64 from an opening 65. This arrangement is the
duckbill angular adjustment and locking means. In operation, flap
67 is flexed sidewise or outwardly to disengage the pin member 64
from an opening 65. At the same time the lever 66 is moved upwardly
or downwardly to register another opening 65 with pin member 64.
Release of the flap 67 permits pin member 64 to project into a
registered opening and lock the lever and duckbills in an angular
position.
This invention thus provides an improved vaginal speculum utilizing
specific locking features and a flexible hinge. The flexible hinge
may be formed integral with a single frame, that is, it is molded
directly into and with the frame. It may, however, be integral with
only one frame part and mechanically or otherwise bonded or joined
to the other part.
While other modifications of this invention and variations of
apparatus may be employed within the scope of this invention and
have not been described or illustrated, the invention is intended
to include all such modifications as may ordinarily be embraced
within the following claims.
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