GB2557979A

GB2557979A - Speculum

Info

Publication number: GB2557979A
Application number: GB1621819.0A
Authority: GB
Inventors: Martin Ford Jonathan
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-12-21
Filing date: 2016-12-21
Publication date: 2018-07-04
Anticipated expiration: 2036-12-21
Also published as: WO2018115890A1; GB2557979B; GB201621819D0; EP3558089A1

Abstract

A speculum 10 comprising a first part 100 - preferably comprising a first blade 110 and a first handle 120 - and a second part 200 - preferably comprising a second blade 210 and a second handle 220 - and wherein the first part 100 and second part 200 are releasably coupled. A releasable coupling member - which preferably comprises a male part 130 provided on the first part 100 and a female part (300, Fig 8) provided on the second part 200 is also taught. A releasable coupling member of this sort may further form the pivot point about which the blades 110, 210 pivot. The releasable coupling member may further be arranged to be released through movement of the first part and/or the second part, preferably through deformation of the first 100 or second 200 part relative to the other. A method of using a speculum of this sort is also taught.

Description

(71) Applicant(s):

Jonathan Martin Ford (56) Documents Cited:

WO 2012/056254 A1 WO 1990/008499 A1 US 20020022771 A1

A61B 1/303 (2006.01)

WO 2011/033333 A1 US 4206750 A

West Drive, Neston, Cheshire, CH64 OSA, United Kingdom (72) Inventor(s):

(58) Field of Search:

INT CL A61B Other: WPI, EPODOC

Jonathan Martin Ford (74) Agent and/or Address for Service:

Appleyard Lees IP LLP

Clare Road, HALIFAX, West Yorkshire, ΗΧ1 2HY, United Kingdom (54) Title ofthe Invention: Speculum

Abstract Title: Speculum having detachable blades (57) A speculum 10 comprising a first part 100 - preferably comprising a first blade 110 and a first handle 120 - and a second part 200 - preferably comprising a second blade 210 and a second handle 220 - and wherein the first part 100 and second part 200 are releasably coupled. A releasable coupling member - which preferably comprises a male part 130 provided on the first part 100 and a female part (300, Fig 8) provided on the second part 200 - is also taught. A releasable coupling member of this sort may further form the pivot point about which the blades 110, 210 pivot. The releasable coupling member may further be arranged to be released through movement ofthe first part and/or the second part, preferably through deformation of the first 100 or second 200 part relative to the other. A method of using a speculum of this sort is also taught.

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FIG. 1

FIG. 2

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FIG. 4

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FIG. 5

FIG. 6

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200

240

FIG. 7

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FIG. 9

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FIG. 10

FIG. 11

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Release coupling \_>

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FIG. 12

Speculum

Field

The present invention relates to a speculum and a method of using a speculum.

Background to the invention

Specula (alternatively speculums; singular: speculum; also known as diopter or dioptra) are medical devices for facilitating inspection, examination and/ or investigation of orifices or lumens, such as vaginal, rectal, nasal, aural or oral orifices in animals, including humans. Generally, specula allow for direct inspection ofthe orifices. In contrast, endoscopes generally allow for indirect inspection via optics, for example. Forms, shapes and/or other functional aspects of specula may be designed to be appropriate for particular characteristics of the particular orifice with which they are intended to be used. Typically, a speculum comprises one or more blades having handles, which may be inserted into an orifice to dilate the orifice for inspection. For example, a bivalved or two blade vaginal speculum, such as a Cusco speculum, comprises two hinged blades. This two blade speculum may be closed to facilitate entry into an orifice and subsequently opened to dilate the orifice. Alternatively, a single blade speculum, such as a Sims speculum, may be inserted into the orifice and subsequently manipulated to view the orifice and tissue forming walls of the orifice.

Specula may be used to dilate orifices such that other procedures beyond just inspection may be facilitated. For example, a speculum may be used to dilate an orifice to permit insertion of another medical device, for example an endoscope, into the orifice and/or to perform operative procedures, for example a biopsy. While two blade specula may better facilitate inspection of orifices compared with single blade specula, a range of movement afforded by the two blade specula may be more limited compared with the single blade specula. For example, an inspection passageway provided by a two blade vaginal speculum may restrict or limit movement of a hysteroscope inserted into an orifice via or through the inspection passageway. In contrast, while single blade specula may afford greater range of movement of the hysteroscope compared with two blade specula, inspection of the orifices when single blade specula are used may be more limited, for example a more limited field of view may be achieved compared with the two blade specula.

Hence, there is a need to improve specula, to facilitate inspection and to facilitate other procedures.

Summary of the Invention

It is one aim of the present invention, amongst others, to provide a speculum which at least partially obviates or mitigates at least some of the disadvantages of the prior art, whether identified herein or elsewhere. For instance, it is an aim of embodiments of the invention to provide a speculum that may facilitate inspection of an orifice. For instance, it is an aim of embodiments of the invention to provide a speculum that may facilitate other procedures.

A first aspect of the invention provides a speculum comprising:

a first part; and a second part; and wherein the first part and the second part are releasably coupled.

A second aspect of the invention provides a method of using a speculum according to the first aspect, wherein the method comprises: releasing the coupling.

Detailed Description of the Invention

According to the present invention there is provided a speculum and a method of using a speculum, as set forth in the appended claims. Other features of the invention will be apparent from the dependent claims, and the description that follows.

Throughout this specification, the term “comprising” or “comprises” means including the component(s) specified but not to the exclusion of the presence of other components. The term “consisting essentially of’ or “consists essentially of” means including the components specified but excluding other components except for materials present as impurities, unavoidable materials present as a result of processes used to provide the components, and components added for a purpose other than achieving the technical effect of the invention, such as colourants, and the like.

The term “consisting of” or “consists of’ means including the components specified but excluding other components.

Whenever appropriate, depending upon the context, the use of the term “comprises” or “comprising” may also be taken to include the meaning “consists essentially of” or “consisting essentially of’, and also may also be taken to include the meaning “consists of’ or “consisting of’.

The optional features set out herein may be used either individually or in combination with each other where appropriate and particularly in the combinations as set out in the accompanying claims. The optional features for each aspect or exemplary embodiment of the invention, as set out herein are also applicable to all other aspects or exemplary embodiments of the invention, where appropriate. In other words, the skilled person reading this specification should consider the optional features for each aspect or exemplary embodiment of the invention as interchangeable and combinable between different aspects and exemplary embodiments.

The first aspect of the invention provides a speculum comprising:

In this way, the speculum may be inserted into an orifice and the orifice dilated using the first part and the second part, thereby facilitating inspection, for example. Subsequently, the first part and the second part may be uncoupled, for example separated and/or completely separated, while inserted in the orifice i.e. in situ. The uncoupled first part or the uncoupled second part may be subsequently retracted from the orifice, while the uncoupled second part or the uncoupled first part may remain inserted in the orifice, respectively, thereby facilitating other procedures, for example endoscopy or the insertion of instruments for measurements or for operative procedures. The uncoupled first part or the uncoupled second part may be subsequently reinserted into the orifice and recoupled with the uncoupled second part or the uncoupled first part remaining inserted in the orifice, respectively, thereby facilitating reinspection, for example.

In an example embodiment, the speculum comprises a vaginal speculum. In an example embodiment, the speculum is a vaginal speculum.

In an example embodiment, the first part comprises a first blade and a first handle and the second part comprises a second blade and a second handle. The first blade may be coupled to the first handle, for example non-releasably coupled, rigidly coupled, weldably coupled, adhesively coupled and/or mechanically coupled. The first blade may be formed with the first handle, for example integrally formed, monolithically formed, moulded, cast and/or machined. The second blade and the second handle may be coupled and/or formed similarly to the first blade and the first handle. In this way, the first part and/or the second part may be readily provided, for example economically manufactured.

For example, the speculum may comprise a bivalved vaginal speculum, related to and/or having a form and/or having a shape and/or having a basic function according to a Collin, a Cusco, a DeVilbiss, a Grave, a Pederson, a Semm, a Seyffert, a Trelat or a Winterton speculum.

In an example embodiment, the speculum comprises a releasable coupling member arranged to releasably couple the first part and the second part. In an example embodiment, the releasable coupling member is released by movement of the first part and/or the second part. The releasable coupling member may be provided by the first part and/or the second part. Additionally and/or alternatively, the releasable coupling member may be provided in addition to the first part and/or the second part, for example, an independent and/or separable component or assembly. The movement of the first part may be relative to the second part. The movement of the first part may be independent of the second part. The movement of the first part may be transverse or orthogonal to an axis of the first part. The movement of the first part may be acute or oblique to the axis of the first part. The movement of the first part may be aligned or parallel with the axis of the first part. The movement of the first part may be a linear movement. The movement of the first part may be a non-linear movement, for example an arcuate movement. The movement of the first part may comprise a single movement. The movement of the first part may comprise a plurality of movements, for example movements in different directions. The movement of the second part may be similar to the movement of the first part. In this way, the releasable coupling member may be readily released while the speculum is in situ.

In an example embodiment, the movement of the first part and/or the second part comprises a single-handed movement. In this way, for example, the second part may be held in one hand, so that the speculum may remain in situ, and the releasable coupling member may be released by the movement of the first part using the other hand, thereby facilitating release of the releasable coupling member.

In an example embodiment, the releasable coupling member is coupled and/or recoupled by a reverse movement of the first part and/or the second part. In other words, the coupling and/or recoupling reverse movement of the first part and/or the second part is a reverse of the uncoupling movement of the first part and/or the second part, described herein.

In an example embodiment, the releasable coupling member is released by deformation of the first part and/or the second part. The deformation of the first part may be an elastic deformation, such that the first part may tend to move back to an original shape after deformation. The deformation of the first part may be due to an external force, for example a tensile or compressive force applied to the first part. The deformation of the first part may comprise decreasing a spacing between portions of the first part, for example opposed portions of the first part and/or opposed portions of the first blade. The deformation of the first part may comprise increasing the spacing between the portions of the first part, for example the opposed portions of the first part and/or the opposed portions of the first blade. In this way, the releasable coupling member may be readily released, for example single handedly.

In an example embodiment, the speculum comprises a portion arranged to tend to increase a flexibility and/or reduce a stiffness of the first part or the second part, thereby facilitating release of the releasable coupling member by the movement of the first part and/or the second part. In this way, the external force required to deform the first part or the second part may be decreased.

In an example embodiment, the speculum comprises an actuator arranged to release the releasable coupling member. For example, the speculum may comprise a switch, a button, a lever and/or a latch arranged to release the releasable coupling member.

In an example embodiment, the first part and the second part are rotatable relative to one another, about the releasable coupling member. The releasable coupling member may define and/or provide an axis of rotation for the relative rotation of the first part and the second part. The axis of rotation may be transverse or orthogonal to the axis of the first part and/or the axis of the second part. In this way, the speculum may be opened and/or closed, according to the relative rotation of the first part and the second part about the releasable coupling member.

In an example embodiment, the releasable coupling member comprises:

a female part provided by the first part; and a male part provided by the second part;

wherein the male part and the female part are arranged to control the relative position of the first part and the second part as they rotate relative to one another.

Additionally and/or alternatively, the male part may be provided by the first part and the female part may be provided by the second part.

For example, the female part may be arranged to mate with or receive the male part. In this way, coupling the first part and the second part may be by inserting the male part in the female part. Conversely, uncoupling the first part and the second part may be by removing the male part from the female part. The male part and the female part may define and/or provide the axis of rotation for the relative rotation of the first part and the second part. The male part may comprise a protrusion or projection, for example a pin, a pivot or a trunnion, provided on the first part. The female part may comprise a recess or perforation, for example a blind hole, a through perforation, a cup or a socket, arranged in the second part.

For example, the male part may comprise a pair of trunnions and the female part may comprise a pair of corresponding sockets.

In an example embodiment, the releasable coupling member comprises:

a female part provided by the first part;

and a plurality of male parts provided by the second part;

wherein the female part and the plurality of male parts are arranged to control the relative position of the first part and the second part as they rotate relative to one another.

In an example embodiment, the releasable coupling member comprises:

a plurality of female parts provided by the first part;

and a male part provided by the second part;

wherein the plurality of female parts and the male part are arranged to control the relative position of the first part and the second part as they rotate relative to one another.

In this way, the male part may be received in one of the plurality of female parts, thereby varying a relative spacing between the first part and the second part and defining and/or providing a plurality of axes of rotation for the relative rotation of the first part and the second part. For example, the relative spacing between the first part and the second part may be decreased or increased according a size of an orifice and/or as required for inspection. The male part may be arranged to be moveable from a first of the plurality of female parts to a second of the plurality of female parts, for example an adjacent female part, while the speculum is in situ.

In an example embodiment, the releasable coupling member comprises:

a plurality of male parts provided by the first part;

and a plurality of female parts provided by the second part;

wherein the plurality of male parts and the plurality of female parts are arranged to control the relative position of the first part and the second part as they rotate relative to one another.

Additionally and/or alternatively, one or more male parts may be provided by the first part and/or by the second part and/or one or more female parts may be provided by the second part and/or the first part.

In an example embodiment, the releasable coupling member is arranged to be released by movement of the first part and/or the second part generally transverse to an axis of the releasable coupling member, said axis defining the relative rotation of the first part and the second part. For example, the movement of the first part may be parallel to an axis of the first part. For example, the movement of the first part may be towards or away from the orifice when the speculum is in situ i.e. by insertion of the first part further into the orifice or retraction of the first part from the orifice, relative to the second part.

In an example embodiment, the releasable coupling member is arranged to be released by a movement of the first part and/or the second part parallel to an axis of the releasable coupling member, said axis defining the relative rotation of the first part and the second part. For example, uncoupling the first part and the second part may be by removing the male part from the female part, in a direction parallel to the axis of the releasable coupling member.

In an example embodiment, the movement of the first part or the second part is provided by changing a spacing of opposed walls of the first part or the second part, respectively.

For example, the movement of the first part may be provided by pressing the opposed walls of the first part together. Conversely, the movement of the first part may be provided by pulling the opposed walls of the first part apart, for example. Changing the spacing of the opposed walls of the first part may be elastic, such that the spacing of the opposed walls of the first part tends to be restored after the movement. For example, the movement of the first part may be provided by pressing the opposed walls of the first blade of the first part together. Conversely, the movement of the first part may be provided by pulling the opposed walls of the first blade of the first part apart, for example. Changing the spacing of the opposed walls of the first blade of the first part may be elastic, such that the spacing of the opposed walls of the first blade of the first part tends to be restored after the movement. For example, the movement of the first part may be provided by pressing opposed portions of the first handle of the first part together. Conversely, the movement of the first part may be provided by pulling the opposed portions of the first handle of the first part apart, for example. Changing the spacing of the opposed portions of the first handle of the first part may be elastic, such that the spacing of the opposed portions of the first handle of the first part tends to be restored after the movement. Similarly, the movement may additionally and/or alternatively be provided for the second part.

In an example embodiment, the speculum is arrangeable in:

a first configuration, wherein the first part and the second part are coupled by the releasable coupling member; and a second configuration, wherein the releasable coupling member is released and wherein the first part and the second part are uncoupled, wherein the speculum is arranged to move from the first configuration to the second configuration by releasing the releasable coupling member.

For example, in the first configuration, the first part and the second part may be arrangeable in an open configuration and/or a closed configuration. By moving from the first configuration to the second configuration, for example in situ, the first part or the second part may be retracted from the orifice, while the second part or the first part may remain in situ. The speculum may be arranged to move from the first configuration to the second configuration by singlehandedly releasing the releasable coupling member, thereby improving a convenience of use of the speculum.

In an example embodiment, the speculum is arranged to define an inspection passageway in the first configuration and wherein the first part or the second part comprises a transverse aperture, arranged to permit a device to remain in the inspection passageway during conversion from the first configuration to the second configuration.

For example, the inspection passageway may provide for direct inspection of the orifice, via the inspection passageway, in the open configuration. The inspection passageway may provide for insertion of another medical device, for example an endoscope, into the orifice, via the inspection passageway, in the open and/or closed configuration. The transverse aperture may allow the inserted medical device to remain in the inspection passageway during the movement or conversion from the first configuration to the second configuration. The transverse aperture may allow the inserted medical device to remain in the inspection passageway during retraction of the first part or the second part from the orifice, while the second part or the first part may remain in situ. In this way, other procedures requiring or benefiting from dilation of the orifice by the speculum may be facilitated.

The transverse aperture may tend to increase a flexibility and/or reduce a stiffness of the first part or the second part, thereby facilitating movement of the speculum from the first configuration to the second configuration.

In an example embodiment, the speculum comprises a biasing member arranged to bias the speculum in the first configuration. The biasing member may be a part of the releasable coupling member.

In an example embodiment, the speculum comprises a metal, for example, steel, stainless steel, surgical stainless steel, 316 stainless steel, 316L stainless steel or 316LVM stainless steel. Stainless steel specula may be repeatedly sterilized, allowing for reusable specula.

In an example embodiment, the speculum comprises a polymeric composition comprising a thermoplastic polymer. In an example embodiment, the speculum comprises a polymeric composition comprising a thermoplastic polymer. The thermoplastic polymer may be a homopolymer or a copolymer.

Polymeric compositions comprising thermoplastics may be readily formed, for example by extrusion, moulding or injection moulding. Such polymeric compositions may have appropriate mechanical properties suitable for use in speculums. Such polymeric compositions may have appropriate chemical properties suitable for chemical and/or biological resistance. Such polymeric compositions may be of relatively low cost and/or environmental cost, allowing for single-use and/or disposable specula.

The thermoplastic polymer may be selected from a group consisting of poly(methyl methacrylate) (PMMA), acrylonitrile butadiene styrene (ABS), aliphatic or semi-aromatic polyamides, polylactic acid (polylactide) (PLA), polybenzimidazole (PBI), polycarbonate (PC), polyether sulfone (PES), polyetherimide, polyethylene (PE), polypropylene (PP), polymethylpentene (PMP) polybutene-1 (PB-1), polystyrene (PS) and polyvinyl chloride (PVC).

The thermoplastic polymer may be a thermoplastic polyolefin. The thermoplastic polyolefin may be selected from a group consisting of: polyethylene (PE), polypropylene (PP), polymethylpentene (PMP) and polybutene-1 (PB-1).

The polyethylene may be selected from a group consisting of high-density polyethylene (HDPE), medium-density polyethylene (MDPE), linear low-density polyethylene (LLDPE), lowdensity polyethylene (LDPE) and very-low-density polyethylene (VLDPE).

The thermoplastic polymer may have a crystallinity of more than 30%, more than 35%, more than 40%, more than 45%, more than 50%, more than 55%, more than 60%, more than 65%, more than 70%, more than 75%, more than 80%, more than 85%, more than 90%.

The thermoplastic polymer may have an amorphicity of more than 30%, more than 35%, more than 40%, more than 45%, more than 50%, more than 55%, more than 60%, more than 65%, more than 70%, more than 75%, more than 80%, more than 85%, more than 90%.

The polymeric composition may comprise additives, such as fillers and/or colourants. The polymeric composition may be opaque, translucent or transparent. Preferably, the speculum comprises a transparent material.

The polymeric composition may be treated, for example, with antimicrobial compositions. In this way, a cleanliness or hygiene ofthe speculum may be increased.

The polymeric composition may be treated or coated, for example with a lubricant, to reduce a coefficient of friction of a surface of the speculum.

In an example embodiment, a surface of the speculum is untextured. For example, the outer surface may be smooth or polished, without discernible texture. In an example embodiment, the inner surface and/or the outer surface is untextured.

Speculums comprising a polymeric composition as described above may be coupled by adhesive coupling or welding, such as solvent or thermal welding, for example.

In an example embodiment, the speculum comprises a PMMA speculum.

In an example embodiment, the speculum comprises a composite material, for example glassreinforced plastic (GRP).

The second aspect of the invention provides a method of using a speculum according to the first aspect, wherein the method comprises:

releasing a coupling between the first part and the second part.

In an example embodiment, the method comprises:

inserting a device into an inspection passageway before releasing the coupling;

wherein the device remains in the inspection passageway during releasing the coupling.

In an example embodiment, the method comprises:

inserting a device into an inspection passageway before releasing the coupling;

wherein the device remains in the inspection passageway during releasing the coupling and, wherein the first part or the second part comprises a transverse aperture that passes over a device remaining in the inspection passageway after conversion from the first configuration to the second configuration such that said first or second part is thereby freed from said device.

Brief description of the drawings

For a better understanding of the invention, and to show how exemplary embodiments of the same may be brought into effect, reference will be made, by way of example only, to the accompanying diagrammatic Figures, in which:

Figure 1 schematically depicts a side elevation view of a speculum according to an exemplary embodiment of the invention, in use;

Figure 2 schematically depicts a side elevation view ofthe speculum of Figure 1, in use;

Figure 3 schematically depicts a cross-sectional view ofthe speculum of Figure 1 on X-X, in use;

Figure 4 schematically depicts a cross-sectional view ofthe speculum of Figure 1 on X-X, in use;

Figure 5 schematically depicts a rear elevation view ofthe speculum of Figure 1, in use;

Figure 6 schematically depicts a rear elevation view ofthe speculum of Figure 1, in use;

Figure 7 schematically depicts a rear elevation view ofthe speculum of Figure 1, in use;

Figure 8 schematically depicts a side elevation view ofthe speculum of Figure 1, in use;

Figure 9 schematically depicts a side elevation view ofthe speculum of Figure 1, in use;

Figure 10 schematically depicts a cross-sectional view ofthe speculum of Figure 1 on X-X, in use;

Figure 11 schematically depicts a cross-sectional view ofthe speculum of Figure 1 on X-X, in use;and

Figure 12 schematically depicts a method of using the speculum of Figure 1.

Detailed Description of the Drawings

Figure 1 schematically depicts a side elevation view of a speculum 10 according to an exemplary embodiment ofthe invention, in use. Particularly, the speculum 10 comprises a first part 100 and a second part 200. The first part 100 and the second part 200 are releasably coupled.

In this way, the speculum 10 may be inserted into an orifice and the orifice dilated using the first part 100 and the second part 200, thereby facilitating inspection, for example. Subsequently, the first part 100 and the second part 200 may be uncoupled, for example separated, while inserted in the orifice i.e. in situ. The uncoupled first part 100 or the uncoupled second part 200 may be subsequently retracted from the orifice, while the uncoupled second part 200 or the uncoupled first part 100 may remain inserted in the orifice, respectively, thereby facilitating other procedures, for example endoscopy or operative procedures. The uncoupled first part 100 or the uncoupled second part 200 may be subsequently reinserted into the orifice and recoupled with the uncoupled second part 200 or the uncoupled first part 100 remaining inserted in the orifice, respectively, thereby facilitating reinspection, for example.

In more detail, the speculum 10 is a bivalved vaginal speculum. The first part 100 comprises a first blade 110 and a first handle 120 and the second part 200 comprises a second blade 210 and a second handle 220. The first blade 110 is formed with the first handle 120, by moulding. The second blade 210 and the second handle 220 are formed similarly to the first blade 110 and the first handle 120.

The speculum 10 comprises a transparent material, specifically a polymeric composition comprising PMMA, a thermoplastic polymer. An outer surface of the speculum 10 is smooth, without discernible texture. An inner surface of the speculum 10 is also smooth, without discernible texture.

The first blade 110 and the second blade 210 are ergonomically shaped, to be inserted into an orifice. The first handle 120 and the second handle 220 are ergonomically shaped, to be used to single-handedly dilate the orifice.

The first blade 110 is generally bill-shaped, having a length of approximately 120 mm, a width of approximately 40 mm at an open end proximal the first handle 120 tapering to a width of approximately 30 mm at a closed end opposed to the open end, and a height of approximately 20 mm at the open end tapering to a height of 10 mm at the closed end. A cross section of the first blade 110, transverse to a longitudinal axis of the first blade 110, is generally U-shaped, thereby providing an open side. The closed end of the first blade 110 is smoothly rounded. A wall thickness of the first blade 110 is approximately 3 mm. Edges of the wall of the first blade at the open side are flat. The second blade 210 is similarly shaped to the first blade 110.

The first handle 120, having an arcuate I form and a length of approximately 70 mm, extends away from the first blade 110, approximately 10 mm from the open end of the first blade 110, from an outer surface of the first blade 110, opposed to the open side. The second handle 220, having an arcuate Y form and a length of approximately 100 mm, extends away from the open side of the second blade 210 at the open end of the second blade 210. In this way, the curved legs of the arcuate Y form of the second handle 220 and the open end of the second blade define a generally circular form according to a rear elevation view, as described below.

The speculum comprises a releasable coupling member 300 arranged to releasably couple the first part 100 and the second part 200, wherein the releasable coupling member 300 is released by movement of the first part 100 and/or the second part 200. The releasable coupling member 300 is provided by the first part 100 and the second part 200. Specifically, the releasable coupling member 300 comprises a female part 130 provided by the first part 100 and a male part 230 provided by the second part 200. The female part 130 and the male part 230 are arranged to control the relative position of the first part 100 and the second part 200 as they rotate relative to one another. The female part 130 is arranged to mate with or receive the male part 230. In this way, coupling the first part 100 and the second part 200 is by inserting the male part 230 in the female part 130. Conversely, uncoupling the first part 100 and the second part 200 is by removing the male part 230 from the female part 130. The male part 230 and the female part 130 define and provide the axis of rotation for the relative rotation of the first part 100 and the second part 200. The male part 230 comprises a pair of trunnions and the female part 130 comprises a pair of corresponding sockets arranged in the second part 200.

The female part 130 is arranged proximal the outer surface at the open end of the first blade 110, proximal the open side. The male part 230 is arranged proximal an inner surface at the open end of the second blade 210, proximal the open side.

As schematically depicted in Figure 1, the speculum 10 is arrangeable in a first configuration, wherein the first part 100 and the second part 200 are coupled by the releasable coupling member 300. In the first configuration, the first part 100 and the second part 200 are arrangeable in an open configuration and a closed configuration. In the closed configuration, the edges of the open sides of the first blade 110 and the second blade 210 confront. The speculum 10 is moved from the closed configuration to the open configuration by pulling the first handle 120 and the second handle 220 together.

The first part 100 and the second part 200 are rotatable relative to one another, about the releasable coupling member 300. The releasable coupling member 300 defines and provides an axis of rotation for the relative rotation of the first part 100 and the second part 200. The axis of rotation is orthogonal to the axis of the first part 100 and the axis of the second part 200. In this way, the speculum 10 may be opened and/or closed, according to the relative rotation of the first part 100 and the second part 200 about the releasable coupling member 300.

Figure 2 schematically depicts a side elevation view of a speculum 10 according to an exemplary embodiment of the invention, in use. Particularly, the speculum 10 is arrangeable in a second configuration, wherein the releasable coupling member 300 is released and wherein the first part 100 and the second part 200 are uncoupled. The speculum 10 is arranged to move from the first configuration to the second configuration by releasing the releasable coupling member 300.

By moving from the first configuration to the second configuration, for example in situ, the first part 100 or the second part 200 may be retracted from the orifice, while the second part 200 or the first part 100 may remain in situ. The speculum 10 is arranged to move from the first configuration to the second configuration by single-handedly releasing the releasable coupling member 300, thereby improving a convenience of use of the speculum 10.

Figure 3 schematically depicts a cross-sectional view of the speculum 10 of Figure 1, in use. Particularly, Figure 3 schematically depicts the speculum 10 in the first configuration in which an external force F is applied to move the speculum 10 from the first configuration to the second configuration.

The releasable coupling member 300 is released by deformation of the first part 100. The deformation of the first part 100 is an elastic deformation, such that the first part 100 tends to move back to an original shape after deformation. The deformation of the first part 100 comprises decreasing a spacing between portions of the first part, specifically opposed portions of the first part 100. In this way, the releasable coupling member may be readily released, for example single handedly.

In more detail, the movement of the first part 100 is provided by changing a spacing of opposed walls of the first blade 110 of the first part 100, by pressing the opposed walls of the first blade 110 of the first part together. Changing the spacing of the opposed walls of the first part 100 is elastic, such that the spacing of the opposed walls of the first part 100 tends to be restored after the movement.

The movement of the first part 100 is relative to the second part 200. The movement of the first part 100 is independent of the second part 200. The movement of the first part 100 is transverse or orthogonal to an axis of the first part 100. The movement of the first part is a linear movement. The movement of the first part comprises a single movement. In this way, the releasable coupling member may be readily released while the speculum is in situ.

The movement of the first part 100 comprises a single-handed movement. In this way, the second part 200 may be held in one hand, so that the speculum 10 may remain in situ, and the releasable coupling member 300 may be released by the movement of the first part 100 using the other hand, thereby facilitating release of the releasable coupling member 300.

The releasable coupling member 300 is arranged to be released by a movement of the first part 100 parallel to an axis of the releasable coupling member 300, said axis defining the relative rotation of the first part 100 and the second part 200. For example, uncoupling the first part 100 and the second part 200 is by removing the male part 230 from the female part 130, in a direction parallel to the axis of the releasable coupling member 300.

The releasable coupling member 300 is arranged to be coupled and recoupled by a reverse movement of the first part 100.

Figure 4 schematically depicts a cross-sectional view of the speculum 10 of Figure 1, in use. Particularly, Figure 4 schematically depicts the speculum 10 in the second configuration, wherein the releasable coupling member 300 is released and wherein the first part 100 and the second part 200 are uncoupled.

Figure 5 schematically depicts a rear elevation view of the speculum 10 of Figure 1, in use. Particularly, Figure 5 schematically depicts the first part 100 of the speculum 10 in the second configuration, wherein the releasable coupling member 300 is released and wherein the first part 100 and the second part 200 are uncoupled.

Figure 6 schematically depicts a rear elevation view of the speculum of Figure 1, in use Particularly, Figure 6 schematically depicts the second part 200 of the speculum 10 in the second configuration, wherein the releasable coupling member 300 is released and wherein the first part 100 and the second part 200 are uncoupled.

In more detail, the second part 200 comprises a transverse aperture 240 provided in a leg of the arcuate Y form of the second handle 220. In this way, the curved legs of the arcuate Y form of the second handle 220 and the open end of the second blade define the generally circular form according to the rear elevation view, wherein the circular form is interrupted by the transverse aperture 240 provided in the leg of the arcuate Y form of the second handle 220. That is, in contrast with a conventional Cusco speculum, the generally circular form according to the rear elevation view is discontinuous, rather than continuous as is conventionally provided. Furthermore, the transverse aperture 240 tends to increase a flexibility of the second part 200, thereby facilitating release of the releasable coupling member 300 by the movement of the first part 100. In this way, the external force F required to deform the first part 100 is decreased.

Figure 7 schematically depicts a rear elevation view of the speculum of Figure 1, in use. Particularly, Figure 7 schematically depicts the first part 100 and the second part 200 of the speculum 10 in the first configuration, wherein the first part 100 and the second part 200 are coupled by the releasable coupling member 300.

In more detail, the speculum 10 is arranged to define an inspection passageway 400 in the first configuration. The second part 200 comprises the transverse aperture 240, as described above, arranged to permit a device to remain in the inspection passageway 400 during conversion from the first configuration to the second configuration.

The inspection passageway 400 provides for direct inspection of the orifice, via the inspection passageway 400, in the open configuration. The inspection passageway 400 provides for insertion of another medical device 1, for example an endoscope, into the orifice, via the inspection passageway 400, in the open and/or closed configuration. The transverse aperture 240 allows the inserted medical device 1 to remain in the inspection passageway 400 during the movement or conversion from the first configuration to the second configuration. The transverse aperture 240 allows the inserted medical device 1 to remain in the inspection passageway 400 during retraction of the first part 100 or the second part 200 from the orifice, while the first part 100 remains in situ. In this way, other procedures requiring or benefiting from dilation of the orifice by the speculum may be facilitated.

Figure 8 schematically depicts a side elevation view of the speculum of Figure 1, in use, for example inserted into an orifice or lumen. Particularly, Figure 8 schematically depicts the first part 100 and the second part 200 of the speculum 10 in the first, closed configuration, wherein the first part 100 and the second part 200 are coupled by the releasable coupling member 300. Further, Figure 8 schematically depicts the medical device 1 inserted into the inspection passageway 400.

Figure 9 schematically depicts a side elevation view of the speculum of Figure 1, in use, for example inserted into an orifice or lumen. Particularly, Figure 9 schematically depicts the first part 100 of the speculum 10 in the second configuration, wherein the releasable coupling member 300 is released and wherein the first part 100 and the second part 200 are uncoupled. Further, Figure 9 schematically depicts the inserted medical device 1, inserted into the inspection passageway 400, remaining in the inspection passageway 400 during the movement or conversion from the first configuration, as described above, to the second configuration. Specifically, during the movement from the first configuration to the second configuration, the inserted medical device 1 remains in the inspection passageway 400 as the transverse aperture 240 passes over the inserted medical device 1. In the absence of the transverse aperture 240, complete separation of the first part 100 and the second part 200 would either require retraction of the inserted medical device 1, thus contrary to an objective of insertion of the medical device 1, or threading the second part along a full length of the inserted medical device 1. For example, if the inserted medical device comprises forceps, retraction ofthe forceps is required. For example, if the inserted medical device 1 comprises a cable coupled to an apparatus, threading the second part along the full length of the inserted medical device 1, including the cable, and removing the second part 200 from the inserted medical device is not possible without uncoupling the cable from the apparatus. That is, the transverse aperture 240 facilitates complete separation ofthe first part 100 and the second part 200 when the medical device 1 is inserted into the inspection passageway 400.

Figure 10 schematically depicts a cross-sectional view ofthe speculum of Figure 1, in use, for example inserted into an orifice or lumen. Particularly, Figure 10 schematically depicts the first part 100 and the second part 200 ofthe speculum 10 in the first configuration, wherein the first part 100 and the second part 200 are coupled by the releasable coupling member 300. Further, Figure 10 schematically depicts the medical device 1 inserted into the inspection passageway 400.

Figure 11 schematically depicts a cross-sectional view of the speculum of Figure 1, in use, for example inserted into an orifice or lumen. Particularly, Figure 11 schematically depicts the first part 100 of the speculum 10 in the second configuration, wherein the releasable coupling member 300 is released and wherein the first part 100 and the second part 200 are uncoupled. Further, Figure 11 schematically depicts the inserted medical device 1, inserted into the inspection passageway 400, remaining in the inspection passageway 400 during the movement or conversion from the first configuration, as described above, to the second configuration.

In this way, for example, the first part 100 and the second part 200 may be separated completely once a hysteroscope is sited, for example, inserted into the orifice via the inspection passageway 400, thereby reducing and/or removing a limitation of movement ofthe hysteroscope and thereby allowing greater views and ease of surgery. Furthermore, for example, the separating speculum 10 facilitates evaluation of vaginal prolapse, where a single blade, for example the first blade 100 or the second blade 200, is advantageous and in management of obstetric vaginal trauma. In one practical example, in obstetric trauma, including vaginal side wall trauma, instruments such as Spencer Wells Artery forceps may be applied more easily under vision via the inspection passageway 400 and the speculum 10 subsequently separated to facilitate suturing and ensuring an apex of any injury is adequately sutured. Additionally, the speculum 10 allows correct placement of vaginal packs in the management of haemostasis. In other words, the speculum 10 provides the advantages of both conventional single blade and bivalved or two blade specula, without their disadvantages, as described above.

Figure 12 schematically depicts a method of using the speculum 10 of Figure 1.

At step S120, the method comprises releasing a coupling between the first part 100 and the second part 200.

The method may further comprise inserting a device 1 into the inspection passageway 400 before releasing the coupling, wherein the device 1 remains in the inspection passageway 400 during releasing the coupling.

The method may further comprise inserting the device 1 into the inspection passageway 400 before releasing the coupling, wherein the device 1 remains in the inspection passageway 400 during releasing the coupling and, wherein the first part 100 or the second part 200 comprises a transverse aperture 240 that passes over the device 1 remaining in the inspection passageway 400 after conversion from the first configuration to the second configuration such that said first part 100 or second part 200 is thereby freed from said device 1.

In summary, the invention provides a speculum comprising a first part and a second part. The first part and the second part are releasably coupled. In this way, inspection of an orifice may be facilitated.

Although a preferred embodiment has been shown and described, it will be appreciated by those skilled in the art that various changes and modifications might be made without departing from the scope ofthe invention, as defined in the appended claims and as described above.

Attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

All of the features disclosed in this specification (including any accompanying claims and drawings), and/or all ofthe steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1. A speculum comprising: a first part; and a second part; and wherein the first part and the second part are releasably coupled.

2. A speculum according to claim 1, wherein the first part comprises a first blade and a first handle and wherein the second part comprises a second blade and a second handle.

3. A speculum according to any previous claim, wherein the speculum comprises a releasable coupling member arranged to releasably couple the first part and the second part, wherein the releasable coupling member is released by movement ofthe first part and/or the second part.

4. A speculum according to claim 3, wherein the releasable coupling member is released by deformation ofthe first part and/or the second part.

5. A speculum according to any of claims 3 to 4, wherein the first part and the second part are rotatable relative to one another, about the releasable coupling member.

6. A speculum according to claim 5, wherein the releasable coupling member comprises:

a male part provided by the first part; and a female part provided by the second part;

7. A speculum according to claim 6, wherein the releasable coupling member comprises:

a plurality of male parts provided by the first part;

and a plurality of female parts provided by the second part;

8. A speculum according to any of claims 6 to 7, wherein the releasable coupling member is arranged to be released by movement of the first part and/or the second part generally transverse to an axis of the releasable coupling member, said axis defining the relative rotation of the first part and the second part.

9. A speculum according to any of claims 5 to 8, wherein the releasable coupling member is arranged to be released by a movement of the first part and/or the second part parallel to an axis of the releasable coupling member, said axis defining the relative rotation of the first part and the second part.

10. A speculum according to claim 9, wherein the movement of the first part or the second part member is provided by changing a spacing of opposed walls of the first part or the second part, respectively.

11. A method according to claim 10, wherein the method comprises: inserting a device into an inspection passageway before releasing the coupling; wherein the device remains in the inspection passageway during releasing the coupling.

30

12. A method according to claim 10 or 11, wherein the method comprises:

inserting a device into an inspection passageway before releasing the coupling; wherein the device remains in the inspection passageway during releasing the coupling and, wherein the first part or the second part comprises a transverse aperture that passes over a device remaining in the inspection passageway after conversion from the first configuration

35 to the second configuration such that said first or second part is thereby freed from said device.

Intellectual

Property

Office

Application No: GB1621819.0 Examiner: Mr Geraint Davies

11. A speculum according to any of claims 5 to 10, wherein the speculum is arrangeable in:

12. A speculum according to claim 11, wherein the speculum is arranged to define an inspection passageway in the first configuration and wherein the first part or the second part comprises a transverse aperture, arranged to permit a device to remain in the inspection passageway during conversion from the first configuration to the second configuration.

13. A method of using a speculum according to any of claims 1 to 12, wherein the method comprises:

releasing a coupling between the first part and the second part.

14. A method according to claim 13, wherein the method comprises: inserting a device into the inspection passageway before releasing the coupling; wherein the device remains in the inspection passageway during releasing the coupling.

15. A method according to claim 13 or 14, wherein the method comprises: inserting a device into the inspection passageway before releasing the coupling; wherein the device remains in the inspection passageway during releasing the coupling and, wherein the first part or the second part comprises a transverse aperture that passes over a device remaining in the inspection passageway after conversion from the first configuration to the second configuration such that said first or second part is thereby freed from said device.

Amendments to the claims have been filed as follows:

1601 18

1. A speculum comprising: a first part; and

5 a second part;

wherein the first part and the second part are releasably coupled;

wherein the first part comprises a first blade and a first handle and wherein the second part comprises a second blade and a second handle;

wherein the speculum comprises a releasable coupling member arranged to releasably

10 couple the first part and the second part, wherein the releasable coupling member is released by movement of the first part and/or the second part, wherein the movement is provided by deformation ofthe first part and/or the second part.

2. A speculum according to claim 1, wherein the first part and the second part are

15 rotatable relative to one another, about the releasable coupling member.

3. A speculum according to claim 2, wherein the releasable coupling member comprises:

a male part provided by the first part; and

20 a female part provided by the second part;

4. A speculum according to claim 3, wherein the releasable coupling member

25 comprises:

a plurality of male parts provided by the first part;

and a plurality of female parts provided by the second part;

wherein the plurality of male parts and the plurality of female parts are arranged to control the relative position of the first part and the second part as they rotate relative to one

30 another.

5. A speculum according to any of claims 3 to 4, wherein the releasable coupling member is arranged to be released by movement of the first part and/or the second part generally transverse to an axis of the releasable coupling member, said axis defining the

35 relative rotation ofthe first part and the second part.

6. A speculum according to any of claims 2 to 5, wherein the releasable coupling member is arranged to be released by a movement of the first part and/or the second part parallel to an axis of the releasable coupling member, said axis defining the relative rotation of the first part and the second part.

7. A speculum according to claim 6, wherein the movement of the first part or the 5 second part member is provided by changing a spacing of opposed walls of the first part or the second part, respectively.

8. A speculum according to any of claims 2 to 7, wherein the speculum is arrangeable in:

10 a first configuration, wherein the first part and the second part are coupled by the releasable coupling member; and a second configuration, wherein the releasable coupling member is released and wherein the first part and the second part are uncoupled, wherein the speculum is arranged to move from the first configuration to the second 15 configuration by releasing the releasable coupling member.

OO o

co

9. A speculum according to claim 8, wherein the speculum is arranged to define an inspection passageway in the first configuration and wherein the first part or the second part comprises a transverse aperture, arranged to permit a device to remain in the inspection

20 passageway during conversion from the first configuration to the second configuration.

10. A method of using a speculum according to any of claims 1 to 9, wherein the method comprises:

releasing a coupling between the first part and the second part.