EP0608315A4

EP0608315A4 - A speculum.

Info

Publication number: EP0608315A4
Application number: EP92921662A
Authority: EP
Inventors: Eddie Muto; Riccardo Santilli; Andrew John Monk
Original assignee: GYNO MEDICAL HOLDINGS Pty Ltd
Current assignee: GYNO MEDICAL HOLDINGS Pty Ltd
Priority date: 1991-10-17
Filing date: 1992-10-16
Publication date: 1995-09-27
Also published as: WO1993007800A1; NZ244769A; CA2121462A1; EP0608315A1

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 The apparatus is withdrawn from the body, leaving the speculum in place.

Description

A SPECULUM

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 that 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 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 doctor to use and provides a proper view of the area under examination while being relatively comfortable for the patient.

According to a first aspect of the present invention there is provided a speculum comprising primary expansion means to expand a body passage or cavity in which said speculum is inserted and a peripheral expansion surface arranged to support an inner peripheral wall area of the body passage or cavity in an expanded condition of the primary expansion means, such that the expansion force applied by the primary expansion means 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.

In a first embodiment of the first aspect the peripheral expansion surface is preferably formed on a secondary expansion means and a fluid passage is provided between the primary expansion means and the secondary expansion means.

Preferably, said primary and said secondary expansion means are arranged to expand in a radial and circumferential direction only. Preferably, said primary and said secondary expansion means are expanded by means of a fluid pressure. Preferably, the fluid is air.

The primary expansion means preferably comprises a tubular member arranged for insertion, in an unexpanded condition, into the body passage or cavity. The secondary expansion means preferably comprises an annular member mounted to the tubular member substantially adjacent the end of the tubular member inserted innermost into the body passage or cavity.

Preferably, the tubular member comprises a plurality of tubular cells extending substantially parallel to the longitudinal axis of the tubular member. Each tubular cell preferably being connected to each of its adjacent cells so as to enable a flow of expansion fluid through the cells.

Preferably, an optical fibre is arranged to be mounted in the speculum so as to provide a light source at the end of the tubular member which is inserted innermost into the body passage or cavity.

Preferably, the tubular member and the annular member are integrally formed.

Preferably, the tubular member and the annular member are made of a flexible plastics material or a rubber type material. The speculum is preferably disposable.

In a second embodiment of the first aspect the peripheral expansion surface is formed as part of the primary expansion means. The primary expansion means preferably comprises a substantially planar body containing at least one cell means arranged to receive means (e.g. a flow of fluid) to expand the body.

The cell means preferably comprises a tubular cell extending in the body substantially parallel to the direction of insertion of the speculum. Each tubular cell is preferably connected to an adjacent cell so as to enable a flow of expansion fluid through the cells.

According to a third embodiment of the first aspect the primary expansion means comprises a flexible tubular member of decreasing external diameter, and the peripheral expansion surface comprises the external peripheral surface of the tubular member_* The tubular member preferably has an internal annular passageway configured to receive an expansion sleeve of substantially constant external diameter, the external diameter of the expansion sleeve being greater than the smallest external diameter of the tubular member. The expansion sleeve being adapted to slide into said annular passageway until the innermost end of the expansion sleeve contacts against a stop means. The introduction of the expansion sleeve causes the expansion of flexible tubular member so that it applies an expansion force to the peripheral wall area of the body passage or cavity via the peripheral expansion surface.

The third embodiment of the invention preferably further comprises means to hold the expansion sleeve in a position wherein the peripheral wall area of the body passage or cavity is in an expanded condition.

Preferably, the peripheral expansion surface comprises the external peripheral surface of the tubular member.

Preferably, the tubular member is made of a flexible material which may be a plastics material or a rubber type material.

Preferably, the tubular member is of a disposable nature and the expansion sleeve is made of a material which may be sterilised. Preferably, the expansion sleeve is made from a stainless steel.

According to a second aspect of the present invention there is provided an introducing apparatus having a body shaped so as to receive a speculum according to the first aspect of the invention when rolled into a substantially cylindrical shape and wherein the introducing apparatus with the speculum received therein can be inserted into a body passage or cavity and the introducing apparatus removed from the body passage or cavity leaving the speculum positioned in the body passage or cavity.

Preferably, the body of the introducing apparatus has a substantially rounded external periphery.

Preferably, a first end of the introducing apparatus is shaped so as to facilitate introduction of the introducing apparatus into a body passage or cavity.

Preferably, 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 passage or cavity.

Although the embodiments of the speculum and introducing apparatus described subsequently are for use in the vagina, the present invention also relates to speculums and introducing apparatus suitable for use in the rectal passage, the ear and nasal passages. The speculum and introducing apparatus described herein can also be used in veterinary procedures.

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 die tubular member;

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 in-use condition;

Figure 8 is an end view of the speculum shown in Figure 7;

Figure 9 is a plan view of the speculum in the unexpanded condition;

Figure 10 is a cross-sectional side view of a speculum according to a third embodiment in an expanded condition; -

Figure 11 is a side view of the speculum shown in Figure 10 in an unexpanded condition;

Figure 12 is an end view of the speculum shown in Figure 10;

Figure 13 is an enlarged view of a locking clip used in the speculum shown in Figures 10 to 12.

Figure 14 is a top view of an introducing apparatus; Figure 15 is a side view of the introducing apparatus shown in Figure 14;

Figure 16 is a front view of the introducing apparatus shown in Figure 14;

Figure 17 is a rear view of the introducing apparatus shown in Figure 14;

Figure 18 is a cross-sectional view along the line A-A shown in Figure 14;

Figure 19 is a cross-sectional view along the line B-B shown in Figure 14; and

Figure 20 is a perspective view of an optical fibre light source suitable for use with the speculums shown in Figures 1, 7 and 10.

Figure 1 shows a speculum 10 according to a first embodiment of the invention. The speculum 10 is shown in the expanded condition. The speculum 10 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.

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. The 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 pumped 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 10 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 10 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 10 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 ° from the horizontal. This angle provides a view to the vaginal mucosa 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 speculum 10. The optical fibre could then be" disinfected and used in another speculum 10.

Figures 7 to 9 illustrate a second embodiment of the invention. The speculum 50 shown in Figures 7 to 9 is similar in operation to the speculum 10 shown in Figure 1 but has a modified body shape. The modified speculum 50 comprises a primary expansion means in the form of an inflatable substantially 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 56a 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 specification 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. 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 14 to 19 be used. The introducing apparatus 200 comprises an elongate body 202 of C-shaped cross- section. The C-shaped 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 docto ^'slides the introducing apparatus 200 out of the vagina leaving the speculum 50 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 20. 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 50. The probe 302 may be held in position within the speculum 50 by virtue of the air pressure of the adjacent cells 54. Alternatively, the probe 302 may be held by hand or clipped to the speculum.

Figures 10 to 13 illustrate a third embodiment of the invention. The speculum 100 of the third embodiment comprises a tubular member 102 of decreasing external diameter and having a peripheral expansion surface 104. The tubular member 102 is arranged for attachment to a handle assembly 106. Handle assembly 106 comprises a pair of handles 108 and a pair of pivotally connected locking clips 110. Each locking clip 110, as shown in Figure 10, is spring loaded by a spring 113 which biases the locking clip 110 inwardly in a direction towards the centre of the tubular member 102. Each locking clip 110 has an internal ratchet 112 with teeth 112a. The handle assembly 106 may be made of a stainless steel or a plastic material which can be sterilised.

Tubular member 102 has an internal annular passageway 114 configured to receive an expansion sleeve 116. The expansion sleeve 116 is of substantially constant external diameter, is of a length greater than the length of the tubular member 102 and has an external diameter greater than the minimum external diameter of the tubular member 102.

To insert the unexpanded speculum 100 into the vagina of the patient the doctor positions the patient and then inserts the tubular member 102 into the vagina. When positioning the tubular member 102 into the vagina the doctor holds the handles 108. The column strength of the tubular member 102 is sufficient to enable insertion of the speculum 100 into the vagina against the muscle tension of the vagina. When the tubular member 102 is in position in the vagina the doctor slides expansion sleeve 116 into the passageway 114 to expand the speculum 100. As the expansion sleeve 16 slides through the passageway 114 the tubular member 102 is caused to expand because the expansion sleeve is of greater diameter than the diametrical spacing of the passageway 114. The amount of expansion of the tubular member 102 is at the innermost end 117 of the tubular member 102 is dependent upon how far the expansion sleeve 116 is inserted into the passageway 116. Maximum expansion of the innermost end 117 of the tubular member 102 occurs when the end 118 of the expansion sleeve 116 contacts against the inner end 120 of the passageway 114. The doctor therefore slides the expansion sleeve 116 into the passageway 114 until the expansion surface 104 of the tubular member 102 supports the vaginal wall of the patient in a sufficiently expanded condition. Sufficient expansion of the vaginal wall is achieved when the doctor is able to adequately view the vagina and cervix and pass instruments through the centre of the tubular member 102. At this point the flange 122 of the expansion sleeve 116 is locked into behind paired teeth 112a of the ratchets 112 of the locking clips 110 (Figure 7). The ratchet locking arrangement holds the speculum 100 in the expanded condition while the doctor performs his examination.

The pressure applied to the vaginal wall upon expansion of the tubular member 102 is substantially peripherally uniform over the expansion surface 104 in any cross-sectional zone of the vagina. Thus, the pressure felt by the patient is a uniform pressure. The force to expand the vaginal wall is exerted over a larger area than in traditional devices and so the pressure to the area is less making the device more comfortable to the patient.

To withdraw the speculum 100 the doctor releases the flange 122 of the expansion sleeve 116 from the ratchets 112 as shown in Figure 8. The doctor then extracts the expansion sleeve 116 from the passageway 114 so as to allow contraction of the inner member 102. Once the flexible sleeve 116 has been completely withdrawn from the passageway 114, the tubular member 102 will contract to its original condition so that the speculum 100 may be simply withdrawn out of the vagina. The tubular member 102 is preferably made of a silicon or rubber material which is flexible but yet provides sufficient column strength to enable the tubular member 102 to be inserted into the vagina in the unexpanded condition. The tubular member 102 must be of sufficient strength so as to not tear when the expansion sleeve 116 is inserted into the passageway 114. The manufacture of the tubular member 102 out of a material such as silicon or rubber also enables the tubular member 102 to be readily disposable. The tubular member 102 is being connected to the handle assembly 106 by location of the flanged end 124 of the tubular member 102 under the rim 126 of the handle assembly 106. A light adhesive may be necessary to secure the tubular member 102 against the rim 126.

The embodiments of the invention described are advantageous because they provide a substantially uniform pressure over the vaginal wall when the speculum 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 speculums and introducing apparatus described in the embodiments are easy to use for the doctor. In their disposable form the speculums and introducing apparatus described are cheap to manufacture and readily disposable.

Claims

CLAIMS:

1. A speculum comprising primary expansion means to expand a body passage or cavity in which said speculum is inserted and a peripheral expansion surface arranged to support an inner peripheral wall area of the body passage or cavity in an expanded condition of the primary expansion means, such that the expansion force applied by the primary expansion means 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.

2. A speculum according to claim 1 wherein the peripheral expansion surface is formed as part of the primary expansion means.

3. A speculum according to claim 2 wherein the primary expansion means comprises a substantially planar body containing at least one cell means arranged to receive means to expand the body.

4. A speculum according to claim 3 wherein the cell means comprises a tubular cell extending in the body substantially parallel to the direction of insertion of the speculum.

5. A speculum according to claim 1 wherein the peripheral expansion surface is formed on a secondary expansion means and a fluid passage is provided between the primary expansion means and the secondary expansion means.

6. A speculum according to claim 5 wherein the primary expansion means comprises a tubular member arranged for insertion, in an unexpanded condition, into the body passage or cavity. 7. A speculum according to claim 5 wherein the secondary expansion means comprises an annular member mounted to the tubular member substantially adjacent the end of the tubular member inserted innermost into the body passage or cavity.

8. A speculum according to claim 8 wherein the tubular member comprises a plurality of tubular cells extending substantially parallel to the longitudinal axis of the tubular member.

9. A speculum according to claim 8 wherein each tubular cell is connected to an adjacent cell so as to enable a flow of expansion fluid through the cells.

10. A speculum according to claim 1 wherein the primary expansion means comprises a flexible tubular member of increasing external diameter, and the peripheral expansion surface comprises the external peripheral surface of the tubular member.

11. A speculum according to claim 10 wherein the tubular member has an internal annular passageway configured to receive an expansion sleeve of substantially constant external diameter, the external diameter of the expansion sleeve being greater than the smallest external diameter of the tubular member.

12. A speculum according to any one of the preceding claims wherein an optical fibre is arranged to be mounted in the speculum so as to provide a light source at the end of the body which is inserted innermost into the body passage or cavity.

13. A speculum according to any one of the preceding claims arranged to expand in a radial and circumferential direction only. 14. A speculum according to any one of the preceding claims made substantially of a plastics or rubber type material.

15. An introducing apparatus having a body shaped so as to receive a speculum when rolled into a substantially cylindrical shape and wherein the introducing apparatus with the speculum received therein can be inserted into a body passage or cavity and the introducing apparatus removed from the body passage or cavity leaving the speculum positioned in the body passage or cavity.

16. An introducing apparatus according to claim 15 wherein the body of the introducing apparatus has a substantially rounded external periphery.

17. An introducing apparatus according to claim 15 or claim 16 wherein a first end of the introducing apparatus is shaped so as to facilitate introduction of the introducing apparatus into a body passage or cavity.

18. An introducing apparatus according to claim 17 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 passage or cavity.