Disposable Vaginal Speculum

Fiore June 11, 1

Patent Grant 3815585

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)
Family ID: 26803574
Appl. No.: 05/340,208
Filed: March 12, 1973

Related U.S. Patent Documents

Application Number Filing Date Patent Number Issue Date
106346 Jan 14, 1971

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
596399 December 1897 Fox
1300756 April 1919 Moyer
3332414 July 1967 Gasper
3417897 December 1968 Johnson
3421654 January 1969 Hexel

Other References

advertisement of Welch Allyn, Inc., In Medical-Surgical Research, Feb. 1970, page 35..

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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