GB2424585A

GB2424585A - Speculum with attached flexible wall member

Info

Publication number: GB2424585A
Application number: GB0506745A
Authority: GB
Inventors: Howard Clarke
Original assignee: Pelican Healthcare Ltd
Current assignee: Pelican Healthcare Ltd
Priority date: 2005-04-02
Filing date: 2005-04-02
Publication date: 2006-10-04
Anticipated expiration: 2025-04-02
Also published as: GB2424585B; GB0506745D0

Abstract

The speculum comprises blades 2, 3. The blades are moved relative to one another by pressure being applied on the handles 4,5. Attached to the upper blade 2 at attachment point 8 is a flexible wall member. The structure of the wall member allows for expansion of the blades while still maintaining a wall between the blades to avoid body material extending into the cavity/area between the blades. Once the expandable tubular sheath is expanded to its fullest extent it does not retract back to an original form when the speculum is removed from the body.

Description

Speculum The present invention relates to a speculum for viewing an

internal passage or cavity of the body by enlarging the opening to the passage or cavity. In particular but not exclusively, the invention relates to a vaginal speculum.

A speculum allows a healthcare worker such as a medical practitioner or a nurse to view the interior of the body to check for physical abnormalities or signs of disease, such as cervical or rectal cancers. Typically, a speculum comprises a pair of blades, pivotally hinged together towards one end of the blades with there being handles at one end of the blades to cause pivoting of the blades.

In use, the speculum is inserted in a body passage such as the vagina. The handles are brought towards one another to separate the blades to keep the anterior and posterior walls of the vagina apart. Typically, control of the opening of the blades is by way of a nut and screw-thread arrangement, with there being a shank having a screw-thread on a first handle and a nut, which is on an outer side of a second handle. Screwing the nut along the thread against the second handle causes pivoting of the handles away from one another, which in turn, opens the blades. On withdrawal of the device, the nut is moved away from the handle so that the blades can close.

Other mechanisms can be used to alter the position of the handles relative to one another, such as ratchet mechanisms.

Some patients have excess tissue in the body passage. In the case of the vagina, women who have had several pregnancies, a prolapse uterus or other uterine or vaginal damage may have excess vaginal tissue. Also, women who are obese may have an increase in the loose connective tissue beneath the pelvic peritoneum.

In such cases, when such patients have a vaginal speculum examination, the loose vaginal tissue can collapse towards the midline of the blades as the blades attempt to keep the anterior and posterior walls apart.

The collapse of the vaginal walls results in an obscuring of the visualization of the cervix for the purpose of cervical cultures, ruptured membranes, pap smears, biopsy or the visual assessment of the degree of dilation.

The problem of vaginal wall collapse has been addressed. For example, it is known to encase the blades of a speculum with a condom, where the distal end of the condom has been removed. However, this has the disadvantage that the condom may slip off the blades and also, as condoms are made of latex, there is the risk that allergic reactions to the condom material may occur.

US6432048 discusses a speculum including a flexible membrane structure, such as a pair of membranes which extend between the inner edges of each blade. The membranes are expandable but are configured to return to a generally collapsed configuration when the blades are in the close position due to the resilience of the material out of which the membrane is made, such as a latex.

Both of these known pieces of prior art have the

disadvantage that the condom or membrane, being formed of an elastic material naturally force the blades into the closed position. This has the disadvantage that force has to be applied by the medical practitioner or nurse to expand the blades outwardly against the resilient material. It also becomes difficult for the operator to distinguish whether the resilient force acting on the blades is due to the membrane or due to the fact that the blades are pushing against the vaginal wall. If too much force is applied, this may either have the effect of putting strain on the speculum and it failing or it may harm the patient by stretching the vaginal wall.

The current invention seeks to overcome the problems associated with the prior art by providing a speculum having a sheath, extending around the blades to support vaginal tissue but which avoids undue forces from being placed on the speculum and which provides optimum safety and comfort for the patient.

According to the present invention there is provided a speculum comprising two or more blades moveable between an open and a closed position, with there being a flexible wall member being attached to at least one of the blades, the flexible wall member being arranged to retain the lateral walls of the body cavity when the blades are in the open position, wherein the flexible wall member is deformable such that when the blades are expanded into the open position, the flexible wall member expands but on moving the blades to the closed position the flexible wall member remains at least partially in its expanded form.

It is preferred that the flexible wall member is a mesh material such as a woven mesh or a membrane having perforations. The woven structure allows the wall member to stretch and deform in one direction, while the blades expand. However, once deformed, unlike rubber based materials, the flexible wall member does not return to its original formation and remains in an expanded or stretched state.

According to a preferred aspect of the invention, there is provided a speculum comprising two or more blades moveable between an open and a closed position, with the flexible wall member being a flexible tubular sheath attached to at least one of the blades and being extendable around the other of the blades, the sheath being arranged to retain the lateral walls of a body cavity when the blades are in the open position. The flexible tubular sheath is deformable such that when the blades are expanded into the open position, the sheath expands but on moving the blades to the closed position the sheath remains at least partially in its expanded form.

It is preferred that the flexible wall member is fixedly secured to an outer lateral edge of at least one of the blades. However the wall member could be secured to an inner lateral face of the or each blade.

In a preferred arrangement the flexible wall member such as the tubular sheath is secured to each of the two or more blades.

The flexible member may be provided as two elements, each extending from lateral sides of the blades to form wall members extending down each side of the blade.

Alternatively, the flexible wall may be provided as a single body in the form of a sheath, which again provides flexible walls extending between and substantially along the length of the blades.

Advantageously the speculum is a disposable speculum.

Preferably the flexible tubular sheath is formed of a gauze material. A preferred gauze material is made predominantly of a fabric, preferably a man-made material.

It is envisaged that on withdrawal of the speculum from the body opening, the flexible wall member! tubular sheath is arranged to slide along the length of the blades.

It is advantageous that the flexible wall member is affixed to the blade by a method selected from one or more of heat sealing, the application of a non-toxic adhesive, the application of a solvent cement, the application of pressure, RF welding or ultrasonic welding.

It is preferred that the speculum includes handle members associated with the blades that are releasably lockable to maintain the blades in a desired position relative to one another.

Preferably, the speculum is a vaginal speculum.

However, the invention is suitable to other types of speculae such as nasal or rectal speculae.

According to another aspect of the invention, there is provided a flexible wall member such adapted to be used with a speculum as previously described.

Preferably, the flexible wall member is a tubular sheath.

It is envisaged that the flexible wall member such as the tubular sheath comprises a length of material having weakened portions that allow a section of the sheath material to be detached from the length. This provides a form of "tear off" material that can be used as and when required with a speculum. However, it is also envisaged that the flexible wall member may be provided as individual units, which could have on them an area of adhesive so that the unit can be affixed to a speculum by a manufacturer, for example by heating or RF welding. An individual unit could be a flexible tubular sheath of a predetermined length so that it can substantially cover the blades of a speculum.

An embodiment of the invention will now be described with reference to the accompanying figures by way of example only, in which: Figure 1 shows a view of a speculum where the blades are in the closed position; Figure 2 shows a speculum where the blades are in the open position; Figure 3a shows a flexible wall member in the form of a woven mesh; and Figure 3b shows a flexible wall member in the form of a perforate sheet material.

A speculum is generally shown as 1 in Figure 1. The speculum comprises in this case two blades 2, 3 each having a respective handle 4, 5. The jaws are tapered and of a curved profile. However, speculae having jaws of other configurations for example duck-billed speculae or speculae having more than two blades or jaws. The blades are moved relative to one another by pressure being applied on the outer handle 4 and the blades can be held in a fixed position by moving a nut 7 on a threaded stem 6 which is attached to blade 3.

Attached to the upper blade 2 at attachment point 8 is a flexible wall member, which in this case is shown as a flexible sheath or sock 9 which in this case is shown as a gauze material. The gauze material has perforations and has a natural springiness that allows the sheath to be positioned over the end of the blades when in proximity to one another and pulled lengthways down the blade as shown in Figure 2. The attachment point 8 may be either on the upper or the lower blade, or both blades. It is also envisaged that other configurations for attaching the sock to the blade or blades can be used. It is also envisaged that the sheath may be attached on both blades at attachment points or position which are positioned towards the end of each blade.

As shown in Figure 2, the sheath extends from the outer edge of upper blade 2 and is passed around the lower surface of lower blade 3 so that the sheath, which is shown as a flexible tubular sheath can be rolled towards the end of the blades that are held together by the pivot point 10. The sheath can be rolled back fully or partially along the blades. As can be seen, the knitted structure of the flexible tubular sheath allows for expansion of the blades while still maintaining a wall between the blades which avoids body material from extending into the cavity or area between the blades.

Also, where a gauze material is used, it avoids the potential for toxic shock syndrome being induced in an individual that may be sensitive to other materials such as latex which are often used in the medical devices field. Once the blades are expanded, the expandable tubular sheath is expanded to its fullest extent and does not retract back to an original form so that when the speculum is removed from the body, the sheath is retracted back along the blades by friction contact with the body cavity so that the blades are withdrawn easily from the body.

The expanded tubular sheath or sock is useable not only with disposable plastic type speculae but can also be affixed to for example metal speculae which are to be resterilised or composite speculae comprising a mixture of molecules e.g. plastic and metal. The fixing may be either by a mechanical fixing which secures the tubular sheath in position or by a glue or as part of the moulding process when producing the speculum.

As shown in Figure 3a, the flexible wall member of sock can be provided as a woven mesh, having interlacing warp and weft threads. Alternatively, the flexible wall member can be a perforable membrane having holes or cut outs or even slits in it as shown in Figure 3b. The cut outs weaken the sheet/membrane so that it expands in one direction and remains deformed once expanded, so avoiding returning to its original configuration.

Although the invention is particularly adapted for use with vaginal speculae, it is envisaged that the invention is easily applicable to speculae for examination of other bodily orifices such as nasal or rectal speculae.

The invention covers not only individual embodiments as discussed but combinations of embodiments as well. It is to be understood that modifications and variations of the present invention will become apparent to those skilled in the art and it is intended that all such modifications will be included within the scope of the present invention. /

Claims

Claims 1. A speculum comprising two or more blades moveable between an

open and a closed position, with there being a flexible wall member being attached to at least one of the blades, the flexible wall member being arranged to retain the lateral walls of the body cavity when the blades are in the open position, wherein the flexible wall member is deformable such that when the blades are expanded into the open position, the flexible wall member expands but on moving the blades to the closed position the flexible wall member remains at least partially in its expanded form.
2. A speculum according to claim 1, wherein the flexible wall member is selected from a mesh material, a membrane having perforations, or a membrane or fabric having holes or slits within its structure.
3. A speculum according to claim 1 or claim 2, wherein the flexible wall member is a flexible tubular sheath attached to at least one of the blades and being extendable around the other of the blades, the sheath being arranged to retain the lateral walls of a body cavity when the blades are in the open position.
4. A speculum according to claim 4, wherein the flexible tubular sheath is deformable such that when the blades are expanded into the open position, the sheath expands but on moving the blades to the / closed position the sheath remains at least partially in its expanded form.
5. A speculum according to any preceding claim, wherein the flexible wall member is fixedly secured to an outer lateral edge of at least one of the blades.
6. A speculum according to any of claims 1 to 4, wherein the wall member is secured to an inner lateral face of the or each blade.
7. A speculum according to any preceding claim, wherein the flexible wall member is secured to each of the two or more blades.
8. A speculum according to any preceding claim, wherein the flexible member is provided as two elements, each extending from lateral sides of the blades to form wall members extending between each side of the blades.
9. A speculum according to any claims 1 to 7, wherein the flexible wall is provided as a single body in the form of a sheath, which provides flexible walls extending between and substantially along the length of the blades.
10. A speculum according to any preceding claim, provided as a disposable speculum.
11. A speculum according to any preceding claim, wherein the flexible tubular sheath is formed of a gauze material.
12. A speculum according to claim 11, wherein the gauze material is made predominantly of a man-made fabric material.
13. A speculum according to any preceding claim, wherein on withdrawal of the speculum from the body opening, the flexible wall member/ tubular sheath is arranged to slide along the length of the blades.
14. A speculum according to any preceding claim, where the flexible wall member is affixed to the blade by a method selected from one or more of heat sealing, the application of a non-toxic adhesive, the application of a solvent cement, the application of pressure, RF welding or ultrasonic welding.
15. A speculum according to any preceding claim, wherein the speculum includes handle members associated with the blades that are releasably lockable to maintain the blades in a desired position relative to one another.
16. A speculum according to any preceding claim adapted for use as a nasal speculum or rectal speculum.
17. A flexible wall member adapted to be used with a speculum according to any preceding claim.
18. A flexible wall member according to claim 17 comprising a length of material having weakened portions that allow a section of the sheath material to be detached from the length.
19. A speculum as substantially described herein, with reference to and as illustrated in the accompanying figures.
20. A flexible wall member as substantially described herein, with reference to and as illustrated in the accompanying figures.