GB2500241A

GB2500241A - Speculum with mounting unit

Info

Publication number: GB2500241A
Application number: GB1204595.1A
Authority: GB
Inventors: Karen Cheetham; Anthony Thorne
Original assignee: Evexar Medical Ltd
Current assignee: Evexar Medical Ltd
Priority date: 2012-03-15
Filing date: 2012-03-15
Publication date: 2013-09-18
Anticipated expiration: 2032-03-15
Also published as: GB2500241B; WO2013136081A1; GB201204595D0

Abstract

An examination device such as a speculum 10 with a mounting unit 30 comprising a locking device mount for attaching a locking device to the mounting unit 30. The locking device may be a pawl 42 and ratchet 40 or a nut 48 and screw arrangement. The mounting device 30 may also have mounts for a light transmitting member 34, an illuminator or an evacuator tube. Also disclosed is a speculum made of a composition comprising ABS, and a vaginal speculum having a light source and a light transmitting member.

Description

Medical Device

Field of the Invention

5 The invention relates to medical devices, especially for examining body cavities. In particular, the invention relates to a speculum, especially a vaginal speculum. Alternatively, it may relate to other devices, such as endoscopes.

Background to the Invention

10 Vaginal specula are commonly used in examination of the vagina, especially of the cervix. A number of different styles of speculum are available, including tubular, one, two and three bladed devices. Two bladed specula include the Graves-type vaginal speculum and the Pederson-type vaginal speculum both of which comprises two blades which can move relative to one another between open and closed positions, like a duckbill. In use, the blades 15 are inserted into the vagina in the closed position and adjusted into an open position. The blades may be temporarily locked in the open position, allowing the vagina to be held open and enabling access to the region of interest, such as the cervix.

Vaginal specula often employ a lock in the form of a ratchet and pawl arrangement. A 20 ratchet is associated with one of the blades and a pawl with the other. Alternatively, the lock may be in the form of a or a threaded lead screw and locking nut. The lead screw is associated with one of blades and the nut engages with the other to hold the blades in position in relation to each other. The choice of the type of lock to use is generally down to the clinician using the device in question, as some will prefer one over the other. As a 25 result, speculum manufacturers may make the same speculum with different lock mechanisms.

Specula may be provided with a light source to illuminate the area to be accessed. The light source may form part of the speculum, or may be a separate unit. In whatever way the light 30 source is provided, the speculum may comprise a light pipe or other light conducting region

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to transmit light from the source through the speculum. Not all specula require a light source, or light conducting region.

Vaginal specula may be used to allow biopsy or removal of tissue, especially by laser or by 5 high heat cauterisation. Such procedures can generate a large amount of smoke which can be removed via a smoke tube, connected to a vacuum. Again, not all specula require a smoke tube.

It would be particularly advantageous to provide a speculum in which the inclusion features 10 such as the light tube, light source and smoke pipe is optional and that said speculum could be made without requiring significant retooling. It would further be useful if a speculum could be made to accept any locking mechanism, without requiring different designs and tooling to be used for each type of lock.

15 It would further be advantageous to provide a speculum having a light conducting region that is capable of transmitting the light to the distal end of the blades of the speculum.

Most existing specula and other examination devices are made of plastic or metal. As specula are used to hold the vaginal muscles open, and are therefore under a reasonable 20 amount of force, there is a risk, particularly with plastic specula, of shattering. It would be advantageous to provide a speculum made from substantially shatterproof material.

Summary of the Invention

According to the invention, there is provided a mounting unit, for use with an examination 25 device for examining or accessing a body cavity, the examination device being moveable between closed and open positions and lockable in an open position using a locking device; wherein the mounting unit comprises a locking device-mount for mounting the locking device on the mounting unit.

30 The examination device is preferably a speculum, especially a two bladed vaginal speculum.

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Such specula may be used to open the vaginal canal, for examination or treatment purposes. Such vaginal specula generally comprise an upper and a lower blade which are moveable relative to one another between closed and open positions, the blades usually being connected by a hinge. Each blade is usually provided with a handle, the blades being 5 hinged such that when the handles are brought together, the blades are moved into an open position. In order to allow the vaginal canal to be held open, the blades may be temporarily locked into an open position using a locking device, the locking device usually being mounted on one of the handles and interacting with the other handle. As indicated previously, the locking device usually takes one of two forms: a ratchet or a lead screw and 10 nut. The locking device mount is preferably arranged such that either a ratchet or a lead screw can be mounted on it, especially without requiring any modification of the mount.

In use, the mounting unit is preferably attached to, or mounted upon one of the blade handles, usually the lower blade handle, of the speculum. Accordingly, the mounting unit 15 allows the ratchet or lead screw of the locking device to be attached, via the unit, to the blade handle.

The locking device mount is preferably a socket, into which a ratchet or lead screw may be inserted and held in place. The ratchet or screw may be adapted so as to mate with the 20 socket

Preferably the socket is square or rectangular in shape. The socket is preferably provided by an aperture formed in the mounting unit, into which a correspondingly shaped portion of the screw or ratchet may be inserted. The socket is preferably shaped to fit with the end of 25 the screw or ratchet inserted therein.

The mounting unit preferably further comprises a mount for a light transmitting member, especially light pipe mount. A light pipe is a pipe of light transmitting material that transmits light from light source to a region to be illuminated. The light pipe mount may 30 take any appropriate form to allow a light pipe or other light transmitting member to be attached, especially fixedly attached, to the mounting unit. For example, the light pipe

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mount may be shaped to receive a light pipe, such that the light pipe may simply be snap-fitted into the mount. It is particularly useful to be able to mount a light pipe on an instrument handle as such a pipe allows light to be effectively transmitted to the distal part of the instrument. Such a pipe cannot be glued in place as this would alter the refractive 5 index of the pipe and reduce the transmission of light. Accordingly providing a mount for said light pipe is advantageous.

The mounting unit may further comprise an illuminator mount. An illuminator is a light source which may be attached to a speculum and cause light to be transmitted along or 10 through the light pipe to the area to be illuminated. The illuminator mount may take any appropriate form to allow a illuminator to be attached, especially fixedly attached, to the mounting unit. For example, the illuminator mount may be shaped to receive a illuminator, such that the illuminator may simply be snap-fitted into the mount.

15 In one embodiment the illuminator is fitted onto rails allowing it to slide into place. In order to prevent the illuminator from being removed, a detent mechanism may be provided. This inhibits the propensity for re use which reduces the likelihood of cross-contamination from one subject to another. Alternatively, the mount may merely locate or support the illuminator and the illuminator be glued in place if necessary. It is particularly 20 advantageous to be able to attach the illuminator to the mount just prior to use of the instrument. . It is likely that the instrument will need to be sterilised prior to use and this cannot easily occur with an illuminator in place. By allowing the illuminator to be fitted to the mount, the instrument can be supplied sterile and the illuminator fitted at the time of use.

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As an alternative, the mounting unit may comprise an illuminator, especially an integrally formed, such as moulded, illuminator.

The mounting unit preferably further comprises an evacuator tube mount. An evacuator 30 tube is a tube provided to remove fluid and the like from the area being examined or treated. It may be for the removal of bodily fluids, such as blood or saliva, or to remove gas

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or liquid generated during treatment, such as smoke generated by cauterisation or laser treatment of tissue to be removed. Such a tube may be connected to a suction device to allow the fluid to be evacuated. It is particularly preferred that the evacuator tube is a smoke tube. The evacuator tube mount may take any appropriate form to allow a evacuator 5 tube to be attached, especially fixedly attached, to the mounting unit. For example, the evacuator tube mount may be shaped to receive a evacuator tube, such that the evacuator tube may simply be snap-fitted into the mount. In that embodiment, the mount may comprise a barbed hose type fitting onto which the evacuator tube may simply be pushed. Alternatively, the mount may merely locate or support the evacuator tube and the evacuator 10 tube be glued in place if necessary. The mounting unit may be further adapted to allow an evacuator tube mounted thereon to interact with a vacuum to apply suction to the evacuator tube. For example, the mounting unit may be provided with a nozzle to allow connection of a vacuum.

15 Also provided is a mounting unit comprising at least one, preferably at least two, preferably at least three, most preferably all four of a locking device mount, a light pipe mount, a evacuator tube mount and an illuminator mount.

By providing a mounting unit for attachment to an examination device, such as a speculum, 20 endoscope or laryngoscope, which has mounts for the various components that may form part of the device, the inventors have been able to reduce the overall production costs and requirements. One style of mounting unit may be produced and can be used with a variety of different devices, especially for example, with differently sized devices. The mounting unit may be used to mount the components required for a particular batch of devices, 25 without the moulds or other tools used to produce the devices being changed. Accordingly, overall tooling costs are vastly reduced. For example, by using the mounting unit, or a speculum handle with the locking device mount, each style or size of speculum may be offered with any locking device that can be adapted to fit the mount, without having to produce new tools for each speculum-locking device combination. The same can be said for 30 each of the light pipe, evacuator tube and illuminator.

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Further provided is a medical device for examining a body cavity comprising a mounting unit according to the invention. The medical device may be, for example a laryngoscope, proctoscope or a endoscope, but is preferably a speculum, especially a two-bladed speculum, particularly a vaginal speculum, such as that described above. In particular, the 5 speculum preferably comprises an upper and a lower blade, the blades being relatively moveable and each being provided with a handle. The blades are preferably pivotably connected at a hinge region, and are moveable between open and closed positions. Movement between open and closed positions is preferably effected by movement of the handles. The mounting unit is preferably attached to the handle of the lower blade, but may 10 be attached to the upper blade handle. The blade handles preferably have outer and inner sides, the inner side of one handle facing the inner side of the other handle. It is particularly preferred that the mounting unit is mounted to the inner side of one of the handles, especially the inner side of the lower blade handle.

15 When the mounting unit is mounted on one handle (such as the lower blade handle) and is provided with a screw or ratchet of the locking device, the second handle (the upper blade handle) is arranged to interact with the screw or ratchet so as to allow locking of the handles in their relative positions. This may be achieved in any appropriate manner. For example, the second handle may be provided with an aperture or passage through which the 20 screw or ratchet may pass. When a screw is used, a locking nut may be threaded onto to the screw and turned until it rests against the outside of the second handle, thereby preventing movement of the handles away from each other and maintaining the open position of the blades. To enable the screw and nut to interact most effectively, a nut mount having a tapered face may be provided to seat the nut against the blade handle. By seating the nut in 25 such a way, the screw and nut may be positioned so that the nut thread matches up with the thread of the screw. The angle of the threaded portion of the nut in relation to the handle may be changed. This may also be achieved by shaping the nut, such that the it can be appropriately positioned against the handle. When a ratchet is used, the ratchet may latch on to the wall of the aperture through the handle, that wall acting as a pawl for the ratchet, 30 again holding the handles in their relative positions. To improve the interaction between the ratchet, the aperture on the second handle may be provided with a pawl unit which slots

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into the aperture and engages the ratchet. In order to return the blades to the closed position, the handles must be released. This is achieved either by undoing the locking nut, or by applying pressure to the ratchet to cause it to disengage from the pawl.

5 The handle to which the mounting unit is attached may comprise an additional socket region located to correspond with the socket region on the mounting unit. For example, when the mounting unit socket is an aperture through the mounting unit, the handle socket region may be an aperture or recess positioned adjacent the mounting unit aperture, forming either an aperture right though both the mounting unit and the handle, or where the handle 10 socket is a recess, a deeper socket. Alternatively, the handle may not comprise such a region.

Also provided is a handle for an examination device, especially for a speculum blade, or a speculum blade having a handle, wherein the handle comprises at least one, preferably at 15 least two, preferably at least three, most preferably all four of a locking device mount, a light pipe mount, a evacuator tube mount and an illuminator mount, as described above.

Further provided is a speculum comprising two relatively moveable blades as previously described, the speculum being provided with at least one, preferably at least two, preferably 20 at least three, most preferably all four of a locking device mount, a light pipe mount, a evacuator tube mount and an illuminator mount. The various mounts are preferably provided on the handles of the speculum, especially on one of the handles of the speculum.

Also provided is a kit for use in producing a medical examination device comprising a 25 mounting unit according to the invention or a speculum handle, especially a speculum blade having a handle, according to the invention, further comprising at least one, preferably at least two, preferably at least three, most preferably all four of: a screw or ratchet type locking device; a light pipe, a evacuator tube; and an illuminator.

30 Preferably the kit comprises a screw or ratchet type locking device. When it does, the screw or ratchet is preferably arranged to interact with the locking device mount. In particular, the

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screw or ratchet preferably comprises a plug region, and the locking device mount preferably comprises a socket, the plug region fitting into, preferably fixedly interacting with, the socket. For example, the socket may be an aperture into which or through which the plug region may be placed. The plug region may comprise one or more compressible or 5 moveable tabs which compress or move as the plug region is inserted into the socket. When the socket is an aperture, the tabs may expand or return to their original position, when the plug region reaches or exits the far side of the aperture. Alternatively, when the socket is an aperture or when it is a recess, it may be provided with one or more cavities on the inner walls of the aperture or the recess, the tabs expanding or moving into the cavities to lock 10 the plug in place. In this embodiment, the ratchet or screw may be attached to the mounting unit after the mounting unit has been attached to the device handle. Similar arrangements may be provided on the other mounts, where appropriate.

In an alternative embodiment, the screw or ratchet may be arranged to be mounted on the 15 mounting unit before the unit is attached to an examination device. For example, the screw or ratchet may be mounted on the unit by passing the screw or ratchet through the unit from the side of the unit which attaches to the handle or other part of the examination device. The screw or ratchet may be wider at one of its ends than the width of the socket and so not pass fully through the socket, being locked in place when the mounting unit is attached to 20 the examination device. Any appropriate shape of socket and screw or ratchet may be used. For example, the screw or ratchet may flare at its end and the diameter of the socket may vary to match. Or the screw or ratchet may be provided with a flange or shoulder that abuts against the back of the mounting unit or against a shoulder in the socket. When the mounting device is attached to the device handle, the widest part of the screw or ratchet 25 may be sandwiched between the handle and part of the mounting device. It is particularly preferred that the screw and mounting unit are arranged to interact so that the screw can pivot in relation to the mounting unit. The screw comprises a head region and a threaded shaft which may interact with a nut. The screw is preferably allowed to pivot so that the shaft moves in an arc. The screw is preferably allowed to pivot so that, in use, the shaft can 30 be positioned to best interact with the nut as the two handles of the instrument with which it is used they are bought together.

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Pivoting of the screw may be achieved by providing the screw with a cylindrical or part cylindrical head. In particular, the screw head may be curved in the region which interacts with the mounting unit. A matching concave socket may be provided in the mounting unit, 5 the socket having a curved inner wall. The two parts can interact allowing the screw head to roll or pivot in the socket.

The features described above may be present on the mounting unit of the invention, whether or not it is part of the kit of the invention.

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The kit preferably comprises a light pipe. It preferably comprises a evacuator tube.

Also provided is a medical device for examining or accessing a body cavity, comprising an insertion region for insertion into the body cavity, wherein at least a portion of the insertion 15 region is made of a composition comprising ABS. Preferably the medical device is a speculum, especially a vaginal speculum. The device is preferably made from a polystyrene ABS composite. Preferably the device comprises at least 23%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80% or 85% ABS. Preferably it comprises less than 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45% or 40% ABS. Preferably it comprises 20 between 20 & 80%, 30 & 80%, 40 & 80%, 30 & 70%, 30 & 60%, 40 & 70%, or 40 & 60%. The insertion region is the region of the device which is for insertion into the body cavity to be examined or treated. When the medical device is a speculum, particularly a two-bladed speculum, the insertion region is one or both of the blades of the speculum.

25 Another aspect of the invention provides a vaginal speculum comprising two or more blades, the blades being moveable between closed and open positions, the blades having proximal and distal ends; the speculum being further provided with a light source and a light transmitting member, wherein the light transmitting member is arranged to transmit light to the distal end of one or both of the blades. Preferably the speculum comprises a 30 light pipe having a proximal and distal end, the proximal end being suitable for receiving light from a light source. The distal end is preferably within 30mm, more preferably within

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25mm, even more preferably within 20mm, even more preferably within 15mm, even more preferably within 10mm, even more preferably within 5mm of the distal in of one of the blades.

5 The invention will now be described in detail, by way of example only, with reference to the drawings in which:

Detailed description of the invention

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Referring to figure 1, in one embodiment, a speculum 10 according to the invention comprises an upper blade 12, having a handle 14, and a lower blade 16, also having a handle 18. The blades are pivotably connected at hinge region 20. In the embodiment shown, this is achieved by providing a short shaft 22 on each side of the lower blade at 15 hinge region, the shafts fitting into corresponding apertures 24 on the upper blade. The shafts define an axis about which the upper blade pivots in relation to the lower blade. Locking pivot pins, rivets or other such fasteners may be provided to ensure that the two blades do not disengage at the hinge region.

20 Figure 1A shows a speculum 10 comprising the mounting unit 30 and ratchet 40, the ratchet interacting with a pawl unit 42 on the upper blade handle 14 so as to lock the handles in position relative to one another.

Figure 1A shows a speculum 10 comprising the mounting unit 30 and screw 44, the screw 25 passing through an aperture 46 in the upper blade handle 14. A locking nut 48 mates with the screw and has been turned so as to meet the upper blade handle so as to lock the handles in position relative to one another.

30 Turning to figure 2, a mounting unit 30 is provided for attachment to a speculum as shown in figure 1. The mounting unit comprises a socket 32 for attaching a locking device to the

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mounting unit. Also provide on the mounting unit is a light pipe mount 34, for attaching a light pipe to the mounting unit and an illuminator mount 36 for mounting an illuminator to provide a light source for the light pipe. The two mounts are arranged in relation to each other to allow the illuminator and light pipe to be in communication and for light to be 5 transmitted from the illuminator to the light pipe. Further provided is a evacuator tube mount 38 to allow an evacuator tube to be attached to the mounting unit. The mounting unit is also provided with a nozzle to allow an attached evacuator tube to communicate with a vacuum to apply suction to the evacuator tube.

10 The lower blade 16 of a speculum according to the invention with a mounting unit 30 attached thereto is shown in figure 3.

The screw 44 or ratchet 40 can both mounted on the mounting unit in the same fashion. They are shown in figures 5 and 6. The screw or ratchet is passed though the socket 32, 15 from the back of the mounting unit, in the direction of arrow A (see figure 1G). The screw or ratchet is provided with a head 47 at its end, which in use abuts against a corresponding shoulder 49 in the socket, preventing further movement of the screw or ratchet through the unit. The mounting unit may then be mounted onto the handle of the device, holding the screw or ratchet in place. In a particular embodiment, the head 47 is in the form of a 20 segment of a cylinder. The socket 32 is shaped so as to fit with the part cylindrical head, having a curved internal wall, so that the screw can pivot slightly within the socket, changing the angle of the shaft of the 49.

Figure 7 shows the lower blade 16, with the mounting unit 30 attached. Mounted on the 25 mounting unit is a light pipe 50. The light pipe extends along the lower blade towards the distal end 52 thereof. The distal end 54 of the light pipe is in close proximity to the distal end 52 of the lower blade, allowing light to be transmitted from the illuminator, along the light pipe, to the end of the speculum and to illuminate the deeper parts of the vaginal canal.

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Referring back to figure 3, a smoke pipe 56 is also mounted on the mounting unit. It is in communication with a nozzle 58, which allows it to be connected to a vacuum so that, in use, smoke may be evacuated from the vaginal canal.

5 The speculum shown may be made of any appropriate sterilisable material. In accordance with one aspect of the invention, the upper and lower blades 12 and 16, and optionally the handles 14 and 18 are made of a plastic composition comprising ABS. The composition may also comprise polystyrene.

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Claims

Claims

1. An examination device for examining or accessing a body cavity, the examination device being moveable between closed and open positions and lockable in an open position using a locking device; wherein the examination device comprises a 5 mounting unit comprising a locking device-mount for mounting the locking device on the mounting unit.

2. A mounting unit for an examination device for examining or accessing a body cavity, the examination device being moveable between closed and open positions 10 and lockable in an open position using a locking device; wherein the mounting unit comprises a locking device-mount for mounting the locking device on the mounting unit.

3. An examination device according to claim 1, or a mounting device according to 15 claim 2, wherein the examination device is a two bladed vaginal speculum.

4. An examination device according to claim 1, or a mounting device according to claim 2, wherein the locking device is a ratchet or a lead screw.

20 5. An examination device according to claim 1, or a mounting device according to claim 2, wherein the mounting unit further comprises a mount for a light transmitting member.

6. An examination device according to claim 1, or a mounting device according to 25 claim 2, wherein the mounting unit further comprises an illuminator mount.

7. An examination device according to claim 1, or a mounting device according to claim 2, wherein the mounting unit further comprises an integrally formed illuminator.

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8. An examination device according to claim 1, or a mounting device according to claim 2, wherein the mounting unit further comprises an evacuator tube mount.

9. A mounting unit comprising at least two of a locking device mount, a light pipe 5 mount, a evacuator tube mount and an illuminator mount.

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10. A handle for an examination device wherein the handle comprises at least two, of a locking device mount, a light pipe mount, a evacuator tube mount and an illuminator mount.

11. A kit for use in producing a medical examination device comprising a mounting unit according to any of claims 2 to 9, further comprising at least two, preferably at least three, most preferably all four of: a screw or ratchet type locking device; a light pipe, a evacuator tube; and an illuminator.

12. A medical device for examining or accessing a body cavity, comprising an insertion region for insertion into the body cavity, wherein at least a portion of the insertion region is made of a composition comprising ABS.

20 13. A medical device according to claim 12, wherein the portion of the insertion region contains at least 30% ABS.

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14. A medical device according to claim 12 or 13, wherein the device is a vaginal speculum.

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15. A vaginal speculum comprising two or more blades, the blades being moveable between closed and open positions, the blades having proximal and distal ends; the speculum being further provided with a light source and a light transmitting member, wherein the light transmitting member is arranged to transmit light to the

30 distal end of one or both of the blades.

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