Sheathed Speculum

Abstract

A speculum is provided, comprising two or more blades moveable between an open and a closed position. A polyisoprene or silicone tubular sheath is attached to at least one of the blades, the sheath being arranged to retain the lateral walls of the body cavity when the blades are in the open position. Sheath attachment means provided on one of the speculum blades facilitate attachment of the sheath to the blade, the attachment means comprising at least one patch or strip of adhesive material extending in a longitudinal direction of the blade.

Claims

1. A speculum comprising two or more blades moveable between an open and a closed position; a tubular sheath comprising polyisoprene or silicone; and an elongate area of adhesive for attaching the sheath to at least one of the blades.

2. A speculum according to claim 1, wherein the sheath is a dip-molded sheath.

3. A speculum according to claim 1, wherein the width of the elongate area of adhesive is less than 10 mm.

4. A speculum according to claim 1, wherein the sheath is greater than 50 microns in thickness.

5. A speculum according to claim 1, wherein the elongate area of adhesive extends in a longitudinal direction of the blade.

6. A speculum according to claim 1, wherein the elongate area of adhesive is provided with a removable protective member.

7. A speculum according to claim 6, wherein the protective member is substantially U-shaped.

8. A speculum according to claim 1, wherein the elongate area of adhesive is spaced from a peripheral feature of the speculum blade such that a non-adhered margin is formed around at least a portion of the attachment means.

9. A speculum according to claim 1, wherein the elongate area of adhesive comprises a double-sided adhesive strip, the first side of the adhesive strip being configured for adhesion to the speculum blade and the second side being configured for adhesion to the sheath.

10. A speculum according to claim 1, wherein the elongate area of adhesive comprises a plurality of spaced blobs of adhesive material, or a spot weld comprising impulse welding, ultrasonic welding or thermal welding.

11. A method of manufacturing a speculum, comprising: forming a polyisoprene or silicone sheath using a dip-molding process; and providing at least one elongate area of adhesive on at least one of the speculum's blades; and bringing the sheath into contact with the adhesive to attach the sheath to the speculum.

12. A method according to claim 11, further comprising applying soapy water to the sheath prior to attaching it to the speculum.

13. A method according to claim 11, wherein the sheath greater than 50 microns.

14. A method according to claim 11, wherein the elongate area of adhesive has a width less than 10 mm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] FIG. 1 is a side view of a typical speculum, the speculum being in a closed configuration.

[0053] FIG. 2 shows a side view of a speculum in accordance with a preferred embodiment of the invention, the speculum being in the closed position and the sheath attached to both the top and the bottom blades.

[0054] FIG. 3 shows the speculum of FIG. 2 in the open position.

[0055] FIG. 4 shows an alternative embodiment of the invention in which the sheath is attached only to the top blade of the speculum.

[0056] FIG. 5 shows an alternative embodiment of the invention in which the sheath is attached only to the bottom blade of the speculum.

[0057] FIG. 6 shows a detailed view of the adhesive strip, protective shield and sheath provided on the speculum in accordance with an embodiment of the invention.

[0058] FIG. 7 shows a plan view of a speculum in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] Referring initially to FIG. 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).

[0060] 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). A longitudinal axis extends between the proximal and distal ends of each blade.

[0061] 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 FIG. 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 at the proximal end 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.

[0062] Thus, the speculum 1 is moveable between a closed configuration (as shown in FIG. 1) or in an open (expanded) configuration in which there is angular separation displacement of the blades (4, 5).

[0063] 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.

[0064] 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.

[0065] Turning to FIGS. 2 to 7, a speculum is provided according to the invention and has a flexible sheath (9) wrapped around a portion of the blades (4, 5). The sheath is a polyisoprene or silicone sheath which is generally tubular in shape, and formed by dip moulding. The thickness of the sheath is approximately 150 microns.

[0066] The sheath (9) has two ends: a proximal (10) end which, in use, is oriented towards the proximal end of the blades 2; and a distal end (11) which, in use, is oriented towards the distal end of the blades (3). A longitudinal axis extends between the opposing (distal and proximal) ends of the sheath. Both ends (10, 11) of the tubular sheath (9) are open to enable the speculum blades to pass through both ends. The distal end 11 of the sheath (9) has a slightly smaller diameter than that of the proximal end (10), such that the sheath (9) is tapered. The nature of the elastic sheath (9) is such that the sheath conforms to and clings to the speculum (1) in a skin-like fashion.

[0067] When the speculum 1 is closed as shown in FIG. 2, the sheath (9) is in its initial, unexpanded form. The sheath may be arranged and configured to resiliently bias the blades (4, 5) towards the closed position, although the urging force and resilience of the sheath may vary according to a variety of factors, such as dimensions, material and so on. The sheath (9) is transparent or semi-transparent such that visualisation of the cavity is not impeded during use.

[0068] FIGS. 3, 4 and 5 show the speculum (1) in an open configuration. With the speculum in this position, the sheath (9) is stretched into an expanded form by the blades. Thus, the diameter of the sheath has increased at the distal end relative to its diameter when in its initial, contracted form. In this position, the resilient sheath may apply a force to the blades to urge them towards the closed position of FIG. 2.

[0069] The sheath (9) is attached to or carried on at least one blade. FIGS. 2 and 3 show the sheath attached to the external surfaces of both the top and bottom blades (4, 5). However, alternative embodiments are shown in FIGS. 4 and 5 which show the sheath (9) attached to only the top (4) and bottom (5) blades respectively. The embodiment of FIGS. 2 and 3 is generally preferred because the attachment to both blades provides a more secure attachment of the sheath and reduces the likelihood that the sheath will rip, wrinkle or bunch up or detach from the speculum (1) during insertion/withdrawal into/from the body cavity.

[0070] The thickness of the sheath is greater than 50 microns, although a thickness in the region of 150 to 300 microns may be preferably. A thickness of 150 microns has been found to be particularly advantageous in reducing the likelihood of damage whilst retaining comfort for the patient and stretching properties.

[0071] The sheath (9) is attached to the blades by an adhesive strip (12) as shown in the Figures although other types of attachment means may be used to similar effect. The strip (12) is an elongate area of adhesive. However, other forms or shapes may be used. For example, a blob or dot of adhesive (or series of spaced blobs or dots of adhesive) may be used instead of an elongate, generally rectangular strip. However, the elongate strip (12) provides enhanced hold of the sheath (9) due to its configuration and shape. Advantageous adhesive materials have been found to include rubber based adhesives, double sided PET tape and high tack transfer adhesive because these work well with the polyisoprene/silicon material of the sheath.

[0072] The strip (12) extends in the longitudinal direction of the blade and/or sheath. If being used with a speculum having curved blades, the adhesive strip may be provided at the apex of the curve.

[0073] FIG. 7 shows an adhesive strip which is spaced from the terminal edges of the sheath 10, 11 such that a narrow adhesive-free margin is provided at the edges of the sheath. Preferably, the margin is as narrow as possible e.g. about 0.5 mm. Thus, the adhesive strip extends substantially the length of the sheath, from one terminal edge to the other. This prevents rolling back of the sheath during insertion, and reduces the likelihood of the sheath being retained in the body during removal. In another embodiment the adhesive extends the entire length of the sheath.

[0074] The adhesive strip does not extend width-wise to the longitudinal edges of the speculum blades. Thus, the area of sheath adjacent the longitudinal side of the adhesive strip is not attached to the speculum, there being a non-adhered margin around the strip which is not in contact with the adhesive. Ideally the strip is as narrow as possible whilst still providing a secure attachment of the sheath. The narrower the strip of adhesive, the more freely the sheath is able to stretch during use. This freedom to stretch provides an enhanced performance because it reduces the force required to open the blades, thus reducing the likelihood of breakage.

[0075] The sheath may be removably attached to the speculum. In such embodiments, the adhesive is selected such that the flexible sheath can be detached and possibly re-attached (for example, for re-positioning of the sheath). In other embodiments, the sheath may only be attached to the speculum once, such that removal and/or re-attachment are not possible.

[0076] During assembly or manufacture, the adhesive strip (12) is attached to an external surface of the speculum blade (4). This may be performed during manufacture of the speculum, such that the speculum is already provided with the adhesive strip in position on the speculum blade. Alternatively, a double-sided adhesive strip may be provided separately from the speculum such that one side of the adhesive strip is applied to a speculum blade prior to fitting the sheath around the speculum on top of the other side of the adhesive strip.

[0077] The adhesive strip (12) is protected by a substantially U-shaped, peel-off shield (14) which is folded over onto itself, having two arms (14 a, 14b). This is shown in FIG. 6. The first arm (14a) of the U is applied to the adhesive strip to cover it. Thus, the adhesive strip is not exposed and cannot stick to the inner surface (9a) of sheath (9) during application of the sheath. The second arm (14b) rests on top of the first arm (14a). The second arm (14b) is of sufficient length to extend beyond the edge of the sheath when the sheath is applied, to enable the second arm (14b) to be easily accessible.

[0078] The sheath (9) is then fitted around the speculum in the desired position. The second arm (14b) of the shield may then be gripped and pulled to peel the shield away from the adhesive strip (12), exposing it. The inner surface (9a) of the sheath is then brought into contact with the adhesive to attach the sheath securely to the speculum blade.

[0079] In cases where a double sided adhesive strip is used, a protective shield can be provided for each adhesive surface of the strip. The protective shield (14) is peeled away from one side of the adhesive strip, and the strip is attached to the blade prior to peeling off the protective shield from the second side of the strip. The exposed second side of the adhesive strip then adheres to the internal surface of the sheath when the sheath (9) is fitted around the speculum (1). Thus, the adhesive strip is sandwiched between the sheath and the speculum blade. Assembly of the sheathed speculum may be performed by the manufacturer or by a practitioner.

[0080] During use (i.e. after manufacture and/or assembly as described above) the distal end (3) of the closed, sheathed speculum shown in FIG. 2 is inserted into the body cavity. The blades (4, 5) are then urged apart to open the speculum as per FIGS. 3, 4 and 5. As the blades open, they push against and retain the cavity walls to enable examination. During this process, the sheath (9) is stretched by the opening blades, thus providing two retaining walls or barriers (13) on either side of the speculum between the edges of the blades. The stretched sheath (9) prevents the cavity walls from collapsing into the speculum between the open blades so that the examination or medical procedure may be carried out without impediment, as most clearly seen in FIGS. 3, 4 and 5.

[0081] After the examination is complete, the practitioner allows the blades (4, 5) to return to their initial, closed position (as per FIG. 2) prior to withdrawing the speculum (1). As the blades close, the elastic sheath (9) contracts back to its original form and size. Thus, the sheath (9) is biased towards its initial, un-stretched configuration. Thus, sagging or ballooning of the sheath (9) is eliminated or at least minimised.

[0082] After use, the sheath (9) may be disposed of along with a disposable speculum. Alternatively, if the sheath is used with a non-disposable speculum, it may be removed and discarded. The non-disposable speculum may then be sterilised prior to re-use.

[0083] The polyisoprene or silicone sheath is made using a dip moulding process. Prior art techniques include welding the sheath together using ultrasonic welding. However, due to the fragile nature of the material and the force required to open the speculum such sheaths are liable to break during assembly or use. The dip moulding process eliminates the potential fragile weld issue and allows the adhesive strip size to be reduced to a minimum amount, thus allowing the maximum surface area of the sheath material to be left un-adhered to the speculum allowing for maximum stretch. This, in turn, reduces the force exerted on the speculum handles.

[0084] Prior to applying the sheath to the speculum, the sheath is rinsed or immersed in soapy water. This removes residue from the surface of the sheath and enables the sheath to glide over the surface of the speculum without sticking to it. This facilitates the assembly process.

[0085] It 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.