AU662177B2 - A speculum - Google Patents

Description

0qT I(TE 21/05/93 APPLN. ID 27859/92 11111 AOJP DATE 22/07/93 PCT NUMBER PCT/AU92/00549 11111 1111111111 AU9227859 ir-,IL Ii i LI IVI'I II I I4iii j I I L rliL IZi N I v1. rr.11 r tlUl lf'J ir lY (51) International Patent Classification 5 (11) International Publication Number: WO 93/07800 A61B 1/32 Al (43) International Publication Date: 29 April 1993 (29.04.93) (21) International Application Number: PCT/AU92/00549 (74)Agents: YEILDS, Karen, Ann et al.; Davies Collison Cave, 1 Little Collins Street, Melbourne, VIC 3000 (22) International Filing Date: 16 October 1992 (16.10.92) (AU).

Priority data: (81) Designated States: AT, AU, BB, BG, BR, CA, CH, CS, PK 8963 17 October 1991 (17.10.91) AU DE, DK, ES, FI, GB, HU, JP, KP, KR, LK, LU, MG, MN, MW, NL, NO, PL, RO, RU, SD, SE, US, European patent (AT, BE, CH, DE, DK, ES, FR. GB, GR.

(71)Applicant (for all designated States except US): GYNO IE, IT, LU, MC, NL, SE), OAPI patent (BF, BJ, CF, MEDICAL HOLDINGS PTY. LTD. [AU/AU]; 960 CG, CI, CM, GA, GN, ML, MR, SN, TD. TG).

Whitehorse Road, Suites 4-6, 1st Floor, Box Hill, VIC 3128 (AU).

Published (72) Inventors; and With international search report.

Inventors/Applicants (for US only) MUTO, Eddie [AU/ AU]; 16/34 Kensington Road, South Yarra, VIC 3141 SANTILLI, Riccardo [AU/AU]; 3 Nicholson Avenue, Reservoir, VIC 3073 MONK, Andrew, John [AU/AU]; 37 Kenmare Street, Box Hill, VIC 3128 6 (54) Title: A SPECULUM Ii (57) Abstract A speculum (10) having a primary expansion means (12) to expand a body passage or cavity in which the speculum (10) is inserted. The speculum (10) has a peripheral expansion surface (12, 14) arranged to support an inner peripheral wall area of the body passage or cavity when the primary expansion means (12) is in an expanded condition. The expansion force applied by the primary expansion means (12) is distributed at least at one cross-sectional zone of the body passage or cavity substantially evenly about the inner peripheral wall area of the expanded body passage or cavity. Also described is an apparatus to receive and introduce a rolled cylindrical speculum into a body passage. The apparatus is withdrawn from the body, leaving the speculum in place.

4 -i ~i P'CEU 6 0 '2075 U 993 -1- A SPECLUM i The present invention relates to a speculum, and more particularly to a speculum for use in gynaecological procedures. The invention also relates to an introducing apparatus for use with a speculum.

A complete pelvic examination comprises an examination of the external genitalia, a speculum examination and a rectovaginal examination. However, a standard pelvic examination normally only comprises an examination of the external genitalia and a speculum examination.

A speculum examination involves the insertion of a speculum into the vagina so IPEA/SUBSTITUTE SHEET 7C i-' -2that the doctor may examine the cervix, obtain a Pap smear, and any other cervical or vaginal culture required by the doctor. During withdrawal of the speculum the doctor also inspects the vaginal mucosa for colour, inflammation, discharge, ulcers and masses.

'Some patients find this procedure quite painful because of the pressure applied i to the walls of the vagina by the speculum. If the patient is anxious about the procedure and is thus particularly tense or if the speculum is used without care the pain felt by the patient can be quite severe. For this reason many patients avoid speculum examinations and therefore place their health at risk.

It is an object of the present invention to provide a speculum which is easy for the i doctor to use and provides a proper view of the area under examination while i 15being relatively comfortable for the patient.

According to the present invention there is provided a vaginal speculum comprising a body member which when located in the vagina is adapted to adopt a substantially tubular configuration, said body member having an expansion surface arranged to support a portion of the vaginal wall, and said body member being divided into a plurality of longitudinal cells, with adjacent cells being interconnected by passage means, said cells being arranged to receive an i- expansion fluid, such that upon introduction of the expansion fluid into said cells the expansion surface of the body member is caused to push the vaginal walls i outwardly so as to enable access to the cervix, the force applied by the expansion 25 surface to the vaginal walls being distributed substantially evenly so as to avoid 4 "distinct points of extreme pressure.

In a first embodiment of the first aspect the speculum has a first end wihich is arranged to be positioned innermost of the vagina and a second end which is distal from the first end and wherein the body member is divided into said plurality of cells by means of a plurality of elongate joints which extend from said i' i i i is

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i-CI i. i I ^--lsC~ -3second end towards said first end, each said joint having a free end which is spaced from said first end.

Preferably, the vaginal speculum is arranged to expand in a radial and circumferential direction only.

Preferably, one longitudinal cell is arranged to be attached to a source of expansion fluid. Preferably, the expansion fluid is air.

Preferably, the body member is formed from two sheets of material which are welded together and wherein said cells are provided by welding portions of the two sheets together.

Preferably, an optical fibre is arranged to be mounted in the speculum so as to provide a light source at the first end of the body.

Preferably, the vaginal speculum is made of a flexible plastics material or a rubber type material. The speculum is preferably disposable.

Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings in which: Figure 1 is a part-sectional side view of a first embodiment of a speculum in an expanded condition; Figure 2 is a side view of the speculum shown in Figure 1 in an unexpanded condition; Figure 3 is a part cross-sectional view along the line marked X-X on Figure 1; Figure 4 is an enlarged view of a number of the cells of the tubular member; i i Figure 5 is a plan view of the tubular member and integrally formed annular member in a flattened out condition; Figure 6 is a side view of the tubular member showing the configuration of the end of the tubular member.

Figure 7 is a side view of a second embodiment of a speculum in an expanded inuse condition; Figure 8 is an end view of the spec-alum shown in Figure 7;

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,It 44 41 4 4 e4 0 i r.t PCT/Au 9 2/00 54 9 RECEIVEL 2 7J UL 19 Figure 9 is a plan view Of the speculum in the unexpandedkondition; Figure 10 is a top view of an introducing apparatus; Figure 11 is a side view of the introducing apparatus shown in Figure Figure 12 is a front view of the introducing apparatus shown in Figure Figure 13 is a rear view of the introducing apparatus shown in Figure Figure 14 is a cross-sectional -view along the line A-A shown in Figure Figure 15 is a cross-sectional view along the line B-B shown in Figure 10; and Figure 16 is a perspective view of an optical fibre light source suitable for use with the speculums shown in Figures 1 and 7.

Figure 1 shows a speculum 10 in the expanded condition. The speculum. comprises a primary expansion means in the form of an inflatable tubular member 12, a secondary expansion means in the form of an inflatable ring 16 and a peripheral expansion surface 14 on the inflatable ring 16.

The speculum 10 is arranged to be inserted into the vagina of a patient when in a collapsed condition. Once the speculum is positioned in the vagina fluid, typically air, is pumped into the tubular member 12 and the inflatable ring 16.

This air expands the speculum 10 such that the peripheral expansion surface 14 is arranged to support the inner wall of the vagina with the vaginal wall in an expanded condition. With the speculum 10 in position and the vaginal wall in this expanded condition the doctor is able to perform the necessary examination of the vagina and the cervix area.

IPEA/SUBSTITUTE SHEET SPCT/AU 9 2 /00 5 49 RECEIVED 27 JUL 1993 -6- The tubular member 12 comprises a plurality of tubular cells 18 which extend substantially parallel to the longitudinal axis of the tubular member 12. Each tubular cell 18 is connected to its adjacent cell by an internal air passage 19. Air passages 19 are preferably located substantially adjacent inflatable ring 16. This internal air passage 19 enables air pumped into a main cell 18a to pass into each of the adjacent cells 18 so as to expand the tubular member 12 when it is positioned in the vagina. A fluid passage 20 is also provided between a cell 18b of the tubular member 12 and the inflatable ring 16. Thus, air pumped through main cell 18a and through adjacent cells 18 eventually passes through fluid passage 20 and into the inflatable ring 16. In this manner inflatable ring 16 may be expanded. Both the internal air passage 19 and the fluid passage 20 are located on the end 22 of the tubular member which is positioned innermost in the vagina.

Inflatable ring 16 is positioned on the end 22 of the tubular member 12.

Inflatable ring 16 is preferably integrally moulded with the tubular member 12.

The inflatable ring 16 is shaped and sized such that when the inflatable ring 16 and the tubular member 12 are expanded, the peripheral expansion surface 14 supports the vaginal wall in an expanded condition. Th peripheral expansion surface 14 extends fully around the inflatable ring 16 such that support and expansion pressure is distributed peripherally evenly over an area of the vaginal wall having substantially the same surface area and circumference as the peripheral expansion surface 14. In this manner, a substantially even expansion force is felt by the patient around her vagina at that cross-sectional zone and there are no points of extreme pressure.

In the expanded condition of the speculum 10 the doctor must have adequate vision through the centre of the tubular member 12 as well as being able to pass instruments such as a swab through the centre of the tubular member 12.

The tubular member 12 and the inflatable ring 16 are expanded by air which is 0EM.^ I IPEA/SUBSTITUTE SHEET p I 9PCT/AU /00 r 49 RECEIVED 2 7 J 199 -7pumped into the main cell 18a of the tubular member 12. The air pumping mechanism 24 is preferably of the type used on standard manual blood pressure testing apparatus.

The speculum 10 is preferably made of a flexible plastics material or a rubber type material. The use of such materials ensures that the cost of the speculum is minimised so that it may be used as a disposable item.

To insert the speculum 10 into the vagina of a patient the doctor properly positions the patient and then, after moving the labia to the side, simply inserts the unexpanded speculum 10 into the vagina. In the unexpanded condition of the speculum 10, the walls of the tubular member 12 are collapsed. Thus the speculum 10 in this condition has a small external diameter. The column strength or strength of the speculum 10 in the longitudinal direction of the unexpanded tubular member 12 is sufficient to enable the doctor to insert the speculum into the vagina. Once the speculum 10 is in position in the vagina the doctor expands the speculum 10 using the pumping mechanism 24. Air passes through the main cell 18a of the tubular member 12 and expansion of the speculum occurs firstly at the innermost end 22 of the tubular member 12. Inflatable ring 16 also expands. The doctor continues pumping the pumping mechanism 24 until the peripheral expansion surface 14 is positioned so as to support the vaginal wall in an expanded condition and there is sufficient access to the cervix and vagina through the centre of the tubular member 12. At this point, the inflatable ring 16 is generally fully expanded and will hold the speculum 10 in the vagina until the doctor releases the valve of the pumping mechanism 24. The expanded external diameter of the inflatable ring 16 is one arrangement of the invention is approximately 50 to 55 millimetres.

Figures 4 and 5 of the drawings highlight the shape of the innermost end 22 of the speculum 10. As best seen in Figure 5 the innermost end 22 is angled at approximately 30 0 from the horizontal. This angle provides a view to the vaginal

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IIPEA/SUBSTITUTE SHEET PCT~ATT q- 9/PA RECEVWZ L~~ -8mucosa so that the doctor may inspect the mucosa for colour, inflammation, discharge, ulcers and masses. The angled end also enables the doctor to examine the entire vaginal wall as the speculum 10 is rotated and withdrawn.

In a preferred arrangement of the invention an optical fibre is passed through one of the cells 18 of the tubular member 12 and is provided with a ground lens at the innermost end 22 of the tubular member 12. In this way, a light source can be provided at the innermost end 22 of the speculum 10. In this arrangement the optical fibre would be arranged in the tubular member 12 such that it may be removed before disposal of the speculumn 10. The optical fibre could then be disinfected and used in another speculuma The sp-.culum 50 shown in Figures 7 to 9 is similar in operation to the speculumn shown in Figure 1 but has a modified body shape. The modified speculum. comprises a primary expansion means in the form of an inflatable subystantially planar thin hollow body 52. The planar hollow body 52 is made of a plastics material and is divided into six cells 54 by means of five elongate joints 56. Joints 56 extend from a first end 58 of the speculum. 50 in a direction substantially parallel to the direction of insertion of the speculum. 50. The free end 56a of each joint 56 is of a rounded configuration and is spaced from the innermost or second end 60 of the speculum 50. The spacing 62 between the free end 5,6a. of each joint 56 and the second end 60 enables a flow of air to be pumped through cell 54a around the free end 56a of the joint 56 and into all of the other cells 54.

The rounded configuration of the free end 56a of each joint 56 facilitates the proper shaping of the second end 60 of the speculumn 50 when it is fully inflated.

The shape of the second end 60 when the speculum 50 is fully inflated is best illustrated in Figure 7. The second end 60 is also shaped so as to provide a proper view of the vaginal mucosa and to enable the vaginal walls to be examined as the speculum 50 is withdrawn.I IPEASUITUTE SHEET ESBTUL SrPT/AU 9 2/00 5 49 RECEIVED 2 7JUL 1993 -9- The planar hollow body 52 is shaped and sized such that when body 52 is inflated the external surface 64 of the planar body 52 supports the vaginal wall in an expanded condition. The shaping of the external surface 64 of the planar body 52 is such as to provide a substantially even expansion force on the vaginal wall so that there are no points of extreme or uncomfortable pressure.

To insert the speculum 50 into the vagina it is recommended that an introducing apparatus 200 of the type shown in Figures 10 to 15 be used. The introducing apparatus 200 comprises an elongate body 202 of C-shaped cross-section. The Cshaped cross-section defines a curved receiving portion 203. The first end 204 of the body 202 is shaped so as to facilitate introduction of the introducing apparatus 200 into the vagina. The second end 206 of the body 202 is shaped so as to provide a handle or gripping portion at which the doctor can hold the introducing apparatus 200 and manoeuvre it in and out of the vagina.

To insert the speculum 50 into the vagina using the introducing apparatus 200 the speculum 50 must be rolled in a direction perpendicular to the longitudinal direction of the cells 54. The speculum 50 when rolled so as to form a substantially cylindrical body is then slid longitudinally into the curved receiving portion 203 of the body 202 of the introducing apparatus 200. The introducing apparatus 200 is then introduced into the vagina. When the introducing apparatus 200 with the speculum 50 therein is correctly positioned in the vagina the doctor slides the introducing apparatus 200 out of the vagina leaving the speculum within. The speculum 50 can then be inflated to enable examination of cervix and vaginal walls. The cervix and adjacent wall area can be illuminated by means of an optical fibre light source 300 of the type shown in Figure 16. The optical fibre light source 300 comprises an optical fibre probe 302 and a light box 304. The probe 302 is sized such that it can be slid between adjacent expanded cells 54 of the speculum The probe 302 may be held in position within the speculum 50 by virtue of the IPEA/SUBSTITUTE SHEET R~iEvLI2 7 JUL 1993 airprssreof the adjacent cells 54. Alternatively, the probe 302 mybe held by hand or clipped to the speculum.

The embodiments of the invention described are advantageous because they provide a substantially uniform pressure over the vaginal wall when the speculumn is in its expanded condition. In this way the patient should feel a continuous expansion of the vagina walls over a large area as opposed to specific pressure points where expansion occurs. Furthermore, the speculumns and introducing apparatus described in the embodiments are easy to use for the doctor. In their disposable forn the speculums and introducing apparatus described are cheap to manufacture and readily disposable.

IIPEN/SUBSTITUTE SHEET

Claims (16)

1. A vaginal speculum. comprising a body member which when located in the vagina is adapted to adopt a substantially tubular configuration, said body member having an expansion surface arranged to support a portion of the vaginal wall, and said body member being divided into a plurality of longitudinal cells, with adjacent cells being interconnected by passage means, said cells being arranged to receive an expansion fluid, such that upon introduction of the expansion fluid into said cells the expansion surface of the body member is caused to push the vaginal walls outwardly so as to enable access to the cerviy, the force applied by the expansion surface to the vaginal walls being distributed substantially evenly so as to avoid distinct points of extreme pressure.

2. A vaginal speculum according to claim 1 having a first end which is arranged to be positioned innermost of the vagina and a second end which is distal from the first end and wherein the body member is divided into said plurality of cells by means of a plurality of elongate joints which extend from said second end towards said first end, each said joint having a free end which is spaced from said first end. :to of

3. A vaginal speculum according to claim 2 wherein the free ends have a rounded end configuration and are of an increased width when compared to the width of the joint. 25

4. A vaginal speculumn according to claim 2 wherein said passage means is located adjacent the first end of the body member and is partially defined by the free ends of the joints. A vaginal speculum. according to claim 4 wherein the expansion of the speculumn at an area adjacent the passage means is greater than in the area adjacent the second end.

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6. A vaginal speculum. according to ay one of tbhe preceding claims wherein at least one said cell is attached to a source of expansion fluid.

7. A vaginal speculum. according to any one of claims 2 to 6 wherein the external diameter of the first end is greater than the external diameter of the front end.

8. A vaginal speculum. according to any one of the preceding claims wherein the body member is formed from a plastics material and wherein said cells are provided by welding portions of the plastics material together.

9. A vaginal speculum. according to any one of the preceding claims wherein an optical fibre is arranged to be mounted in the speculumn so as to provide a light source at the first end of the body.

A vaginal speculum. according to any one of the preceding claims arranged to expand in a radial and circumferential direction only.

11. A vaginal speculum. according to any one of the preceding claims made substantially of a plastics or rubber type material.

12. A combination comprising a vaginal speculum. according to any one of the preceding claims and an introducing apparatus having a body shaped so as to receive said speculum. when rolled into a substantially cylindrical shape and wherein the introducing apparatus with the speculum received therein can be inserted into a vagina and the introducing apparatus removed from the vagina leaving the speculum positioned in the vagina.

13. A combination according to claim 12 wherein the body of the introducing apparatus has a substantially rounded external periphery.I F I1 -13

14. A combination according to claim 12 or claim 13 wherein a first end of the introducing apparatus is shaped so as to facilitate introduction of the introducing apparatus into the vagina.

15. A combination apparatus according to claim 14 wherein a second end of the introducing apparatus distal from said first end is shaped so as to provide a handle or gripping portion at which a doctor can hold the introducing apparatus and manoeuvre it in and out of the body vagina.

16. A vaginal speculum substantially as hereinbefore described with reference to the accompanying drawings. DATED this 21st day of June, 1995. GYNO MEDICAL HOLDINGS PTY. LTD. By its Patent Attorneys SDAVIES COLLISON CAVE t i I I I t pg 4 i