WO2012010857A1

WO2012010857A1 - Speculum

Info

Publication number: WO2012010857A1
Application number: PCT/GB2011/050326
Authority: WO
Inventors: Paul Eakin
Original assignee: Pelican Healthcare Limited
Priority date: 2010-07-21
Filing date: 2011-02-18
Publication date: 2012-01-26
Also published as: GB201012227D0; GB2482284A

Abstract

A speculum is provided, comprising two or more blades moveable between an open and a closed position, and a light mounting device for mounting a light source on the speculum. The light mounting device comprises a first attachment means for attaching the mounting device to the speculum at or towards the speculum mouth; and a second attachment means for attaching the mounting device to a blade of the speculum. The first and second attachment means are in spaced apart relation along the longitudinal axis of a speculum blade.

Description

Speculum

This invention relates to the field of medical tools, in particular to specula. A speculum is a commonly-used medical tool for opening or distending an orifice or cavity of a patient to permit examination of the interior and/or to enable a sample to be taken.

Various forms of specula are known, their designs varying in accordance with the body cavity to be inspected (e.g. vagina, rectum, ear, nostril). However, all forms of specula incorporate the same basic concept: elongate separator elements ('paddles', or 'blades'), typically having a curved cross section, are positioned edge to edge so that in combination they form an elongate channel. The channel narrows towards the end to be inserted into the orifice (the distal end) to aid the insertion process whilst remaining relatively wider at the opposing (proximal) end to facilitate visual examination or insertion of an instrument via the mouth of the speculum.

The two blades are hinged at their broader ends, thus resembling a duck's beak. Thus, the speculum is able to move to move between a closed configuration (i.e. blade edges are adjacent to each other) and an open configuration (i.e. blades are angled away from each other). Handles are attached, usually integrally, at the hinged ends of the blades.

Squeezing of the handles causes the blades to move apart thus dilating the orifice or cavity and enabling examination.

The use of additional tools, implements or medical aids is often required during the examination or surgical procedure. For example, a light source is sometimes required or desired so as to aid visual examination of the cavity or cervix. In other situations, an extraction device may be used to remove or dissipate the smoke generated during certain medical procedures, such as biopsies or induction loop colopscopy, and which would otherwise obscure the practitioner's vision.

Typically, such tools, aids or other accessories are held in proximity to the speculum, either by the practitioner or an assistant. This means that either the practitioner has one less hand free due to holding the accessory, or another person needs to stand close by, potentially crowding the vicinity. Alternatively, the accessory may be placed on a table, bed or a stand nearby. However, this results in the aid being relatively remote from the examination/procedure site, and renders the accessory less effective.

The arrangement described in US 2009/0076334 Al (Chen) attempts to address this problem in relation to the provision of a light source, and discloses an illumination means provided on the blade of a speculum. However, the position of the illumination means is closer to the distal end of the speculum than the proximal (handle) end. This gives rise to the disadvantage that the accessory can only be reached (or, at least, is more easily reached) via the narrower opening at the distal end. This means that access for insertion, cleaning or removal of the accessory is hampered. Moreover, as the accessory is located towards the narrower distal end, where the gap between the blades is smaller than at the mouth or proximal end, the accessory may impede the use or passage of surgical instruments. The accessory becomes, in effect, an obstacle or blockage.

Furthermore, Chen discloses an arrangement wherein the accessory is either 'built into' the internal surface of a blade, or mounted to an external surface via a buckling belt, adhesive or other connection means. Thus, the connection means employed by Chen result in either permanent attachment of the accessory or potentially bulky and cumbersome attachment means. In addition, at least some of the connection means suggested by Chen may serve as traps for dirt or debris, thus posing a hygiene risk.

Another known arrangement is disclosed in US 5,165,387 (Woodson). A light source is mounted within a housing having an integral clip member, the clip member being arranged such that a slot is formed between the housing and the clip member for receiving the speculum. A longitudinally extending ridge is provided on the outside of the housing and is proportioned so as to engage with a slot provided on the interior surface of the speculum. In use, the ridge is received in the slot so as to effect longitudinal alignment of the housing within the speculum and provide resistance against relative lateral rotation. Therefore, any adjustment of the housing to direct light from the light source to a particular area is discouraged. Furthermore, in use the clip member sits on the exterior wall of the speculum blade, resulting in a relatively raised profile and a distal clip end which may cause discomfort or tissue damage if it comes into contact with the patient's body.

An improved arrangement has now been devised.

Thus in accordance with a first aspect of the invention, there is provided a speculum comprising two or more blades moveable between an open and a closed position, and a light mounting device for mounting a light source on the speculum, the light mounting device comprising:

a first attachment means for attaching the mounting device to the speculum at or towards the speculum mouth; and

a second attachment means for attaching the mounting device to a blade of the speculum;

wherein the first and second attachment means are in spaced apart relation along the longitudinal axis of a speculum blade.

Preferably, the light mounting device comprises a body. The body may be a tubular or sheath-like member. The body may be elongate. The elongate body may be arranged to receive, carry or retain the light source, and the first and second attachment means may be provided on the body. The first and second attachment means may be provided at or towards opposing ends of the elongate body.

Preferably, the first attachment means is arranged and configured to permit movement of the light mounting device around the speculum mouth. Thus, the first attachment means may be a hook or clip configured to fit around and/or grip the mouth of the speculum. The first attachment means may be substantially C or U shaped. Thus, the first attachment means permits sliding of one end of the mounting device in relation to the speculum.

Preferably, the second attachment means is a docking member, such as a projection, pin or pivot arranged and configured to mate with a docking formation, such as an aperture, receptacle or recess, provided on the speculum blade. The projection may be configured to snap-fit into the aperture provided on the speculum blade. Thus, the light mounting device may be made to rotate about the projection when the hook is pushed, causing it to slide along the rim of the speculum mouth. In use, this enables the practitioner to direct the light within the speculum to illuminate the cavity exactly as needed. This provides a high degree of control for the practitioner.

Although in a preferred embodiment the body is tubular, other shapes and configurations may be employed to similar effect. Moreover, the tubular body may be a solid tube or may be formed with apertures, recesses or other formations provided in the body.

Preferably, ribs are provided within the elongate body, on the inner surface, the ribs being arranged and configured to hold the light source in a friction- fit relationship. Preferably, the ribs extend in the longitudinal direction of the body.

Preferably, the ribs extend around the entire perimeter of the inner body surface.

Alternatively, the ribs extend around only a portion of the circumference.

Preferably, the ribs extend along the entire length of the body. However, in some embodiments they may only extend along a portion of the body's length. The ribs may be flexible or rigid. The ribs may be tapered towards one end, or may be of constant height.

It is preferred that the body, or at least a portion of the body, is transparent. Preferably, the body may be made entirely or partially of plastic.

Preferably, the body is substantially rigid.

Preferably, the light mounting device is provided on an inner blade surface such that all or part of the light source is mounted within the speculum between the blades. According to a second aspect of the invention, there is provided a speculum comprising two or more blades moveable between an open and a closed position, the light mounting device comprising:

a body having an open first end for receiving the light source and a closed second end comprising a light transmissible window wherein:

i) the mounting device further comprises a first attachment means for attaching the first end of the body to the speculum at or towards the speculum mouth; and

a second attachment means for attaching the second end of the body to a blade of the speculum; and/or

ii) the body is an elongate body arranged to receive, carry or retain the light source positioned between the speculum blades.

Preferably, the first and second attachment means are provided in spaced apart relation along the longitudinal axis of the speculum.

Also in accordance with the present invention, there is provided a method of mounting a light source on a speculum blade, the method comprising the steps of:

i) attaching a first end of a light mounting device to the mouth of the speculum such that limited movement of the first end is permitted around the edge of the mouth;

ii) attaching a second end of the light mounting device to the speculum at a connection point along the longitudinal axis of the speculum blade such that rotational or pivotal movement of the light mounting device is permitted around the connection point. Preferably, the light mounting device of the method is a light mounting device in accordance with the first and/or second aspects of the invention as described above.

These and other aspects of the present invention will now be described by way of example only and with reference to the accompanying drawings in which:

Figure 1 is a side view of a typical speculum, the speculum being in a closed configuration;

Figure 2 shows a light mounting device according to the present invention in isolation from the speculum.

Figure 3 shows an embodiment of the invention comprising the light mounting device of Figure 2 mounted upon the speculum of Figure 1. Figure 4 shows an end view of the light mounting device mounted upon an inner surface of an upper blade of the speculum.

Referring initially to Figure 1, there is shown a vaginal speculum (1) of the type commonly used for dilating the vaginal cavity or orifice of a patient during examination or medical procedure. Such specula are typically manufactured from a plastic or metal material, having a plurality of curved separator elements typically referred to as 'blades' or

'paddles'. In a typical arrangement, there are two blades (4, 5) oriented such that one provides an upper blade (4) and the other provides a lower blade (5). The end of the speculum which will be closest to the practitioner during use of the speculum is typically open and known hereafter as the 'proximal end' or 'mouth' (2). The body cavity may be inspected through the open proximal end or mouth (2). The other end of the speculum, which is inserted into the cavity, is known hereafter as the 'distal end' (3). The blades (4, 5) are coupled such that they can move towards or away from each other. Depending on the coupling arrangement used, this may be angular or lateral movement. In a typical arrangement, as shown in Figure 1, the coupling is a hinge (6) provided at the proximal end (2) of the speculum (1), such that the blades (4, 5) may pivot around the hinge (6) at their proximal ends (2) thus moving the distal ends (3) away from or towards each other. The open mouth (2) formed by the proximal ends of the blades enables a practitioner to insert an examination or surgical device into the speculum through the mouth, and also enabling visual inspection of the cavity or body part.

Thus, the speculum 1 is moveable between a closed configuration (as shown in Figure 1) or in an open (expanded) configuration in which there is angular separation displacement of the blades (4, 5).

The blades (4, 5) are provided, coupled integrally or otherwise, with handles (7, 8). Upper blade (4) is shown as coupled to rear handle (7), and lower blade (8) is coupled to front handle (8). Pivoting the handles (7, 8) together thus causes the blades (4, 5) to move apart into an open (expanded) configuration.

It should be noted that a number of different mechanisms exist for supporting the blades and the present invention is not limited in this regard. The present invention may be used in conjunction with a variety of types or styles of speculum. Turning to Figures 2 and 3, a light mounting device (9) is provided on a speculum (1). The light mounting device has an elongate body (10). The body (10) is a tubular sheath or cylinder having a first end (11) and a second end (12). The first end is open such that a light source can be inserted (wholly or partially) into the body (10). The second end (12) may also be open although it is preferred that the second end is closed in accordance with the second aspect of the present invention. The closed end (12) is provided as a transparent window.

The device (9) is provided with a first attachment (14) means at or towards the first (proximal) end (11) of the body (10). In a preferred embodiment, the first attachment means (14) is a C or U-shaped hook or claw which wraps around and retains a portion of the speculum mouth (2). The hook (14) is configured to permit sliding of the device (9) along the perimeter of the mouth (2) in either direction. The device (9) is also provided with a second attachment means at or towards the second (distal) end (12) of the body (10). The second attachment means (13) is provided along the longitudinal axis of the device in spaced relation from the hook (14).

In a preferred embodiment, the second attachment means is in the form of a docking projection (13) such as a projection or pin which extends away from the body (10) of the light mounting device (9). The docking projection (13) is arranged and configured to cooperate or mate with a complimentary docking formation formed in or provided on one of the speculum blades. A preferred docking formation is shown in Figure 3 as an aperture (15) formed in the upper blade of the speculum, although other forms of docking formation may be used. The docking projection (13) is pushed into and through the aperture (15) formed in the upper blade (4), thus forming a connection between the device (9) and the blade. Thus, when the proximal end of the mounting device is pushed to one side or the other, the body of the device is able to rotate around the projection which acts as a pivot. Thus, the attachment means (13) acts as a pivot around which the device (9) may turn.

In a preferred embodiment, the projection (13) may be pushed back through the aperture (15) is releasable to allow the device to be demounted from the speculum. The connection between the projection and the aperture is a 'snap fit' or push fit engagement, although other types of connection may be employed.

In order to provide the desired snap fit or push fit engagement, the docking projection (13) is provided with a securing means. The securing means may be an enlarged or bulbous portion provided at the distal end of the projection (13) such that upon passage of the enlarged portion through the aperture (15), the device is held in place in a relatively secure manner. Removal of the device (9) is effected by application of sufficient force to urge the enlarged portion of the protrusion (13) back through the aperture, thus releasing the device from the speculum. However, in an alternative embodiment, the light mounting device is not removable from the speculum.

Longitudinal ribs or projecting spines (16) are provided around the inner surface of the light mounting device, as shown in Figure 4. The ribs extend around the entire inner circumference of the body, although in other embodiments the may only extend partially round the body. The ribs grip the light source, and facilitate holding of the light source by providing a friction fit. Typically, the mounting device is positioned within the speculum during use as shown in Figure 3, and is held in place between the two blades (4,5) and towards the mouth (2). The light source (not shown in the Figures) may be held entirely within the speculum, or part of it may protrude from the mouth (2). Alternatively, the light mounting device may be secured to the external surface of a blade, but this is generally less preferred as the mounted device can interfere with insertion into and/or retraction of the speculum from the body cavity.

Typically the device is relatively short such that the second attachment means (13) is provided closer to the mouth end (2) of the speculum than the distal end (3). This provides easy access for mounting and de -mounting of the device.

It will be understood by the skilled addressee that the accessory could be mounted on either of the blades although mounting on the upper blade may generally be preferred. During use, the device (9) is attached to the speculum (1) by hooking the claw (14) around the edge of the speculum mouth (2) and pushing the projection (13) through the aperture (15) formed in the upper blade (4). Thus, the light mounting device is securely mounted to the speculum. A light source (not shown) is then inserted into the open end (11) of the device. The light source may be completely or partially contained within the mounting device. An advantage of the invention is that during use the practitioner may adjust the position of the device (and light source contained therein) because a limited degree of movement is possible as the free end of the mounting device slides along the rim of the mouth, rotating about the projection (13). The practitioner may push the first end (11) of the device to one side or another, sliding the hook (14) along the mouth edge of the speculum and causing rotation of the device about the projection (13). This provides the practitioner with the ability to adjust the light source and provide optimal illumination of the body cavity.

Another advantage provided by this arrangement is that the closed-ended sheath (10) protects the light source during use, and eliminates or reduces the need to sterilise the light source after each use.

Another advantage is that the mounting device is mounted at the mouth (2) of the speculum, providing easy access during use and/or assembly.

Another advantage provided by this arrangement is that the attachment means can be easily and cheaply incorporated into existing speculum and accessory designs.

Another advantage provided by this arrangement is that the mounting device (9) is cheap and easy to manufacture, having a simple design.

Another advantage provided by this arrangement is that the ribs (16) provide retain the light source securely within the device. Another advantage is that the device is easy and simple to use, and provides illumination of the body cavity without the need for the practitioner to hold the device or light source. Thus, the practitioner's hands are free for other purposes.

The device may be adapted to mount other accessories, such as smoke extraction devices etc., to the speculum rather than a light source. -l ilt should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be capable of designing many alternative embodiments without departing from the scope of the invention as defined by the appended claims. In the claims, any reference signs placed in parentheses shall not be construed as limiting the claims. The word "comprising" and "comprises", and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, "comprises" means "includes or consists of and "comprising" means "including or consisting of. The singular reference of an element does not exclude the plural reference of such elements and vice-versa. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

Claims

1. A speculum comprising two or more blades moveable between an open and a closed position, and a light mounting device for mounting a light source on the speculum, the light mounting device comprising:

2. A speculum according to claim 1 wherein the first attachment means is configured to permit movement of the mounting device around the speculum mouth.

3. A speculum according to claim 1 or 2 wherein the mounting device is pivotable or rotatable about the second attachment means, at least to a limited degree.

4. A speculum according to any preceding claim wherein the first and second

attachment means are provided on an elongate body, the body being arranged to receive, carry or retain the light source.

5. A speculum according to claim 4 wherein the body is a tube or cylinder arranged to receive the light source.

6. A speculum according to claim 5 wherein the tube or cylinder has an open end for insertion of the light source and a closed clear window at the opposing end through which light is directed.

7. A speculum according to claims 4 to 6 wherein ribs are provided within the elongate body, the ribs being arranged and configured to hold the light source in a friction- fit relationship.

8. A speculum according to any preceding claim wherein the first attachment means is a hook or clip configured to fit around the mouth edge of the speculum.

9. A speculum according to any preceding claim wherein the second attachment

means is a projection arranged and configured to mate with an aperture, receptacle or recess provided on the speculum blade.

A speculum according to claim 9 wherein the aperture, receptacle or recess is accessed at the inside surface of the speculum blade.

A speculum according to any preceding claim wherein all or part of the light source is mounted within the speculum between the blades.

A speculum comprising two or more blades moveable between an open and a closed position, the light mounting device comprising:

13. A speculum according to claim 12 wherein the first and second attachment means are provided in spaced apart relation along the longitudinal axis of the speculum.

14. A speculum according to claim 13 wherein the light mounting device is removable from the speculum.

15. A speculum according to any of claims 12 to 14 wherein the first attachment means is a hook, claw or clip arranged and configured to fit around the edge of the speculum mouth.

16. A speculum according to any of claims 12 to 15 wherein the second attachment means is a projection arranged and configured to mate with an aperture, receptacle or recess provided on the speculum blade.

17. A method of mounting a light source on a speculum blade, the method comprising the steps of:

ii) attaching a second end of the light mounting device to the speculum at a connection point along the longitudinal axis of the speculum blade such that rotational or pivotal movement of the light mounting device is permitted around the connection point.

18. The method of claim 17 wherein the light mounting device is in accordance with any of claims 1 to 16.