GB2578771A

GB2578771A - Vaginal speculum

Info

Publication number: GB2578771A
Application number: GB1818183.4A
Authority: GB
Inventors: Gauden Neil
Original assignee: Robinson Healthcare Ltd
Current assignee: Robinson Healthcare Ltd
Priority date: 2018-11-08
Filing date: 2018-11-08
Publication date: 2020-05-27
Also published as: GB201818183D0; WO2020099854A1

Abstract

A vaginal speculum comprising a pair of pivotally connected plastic components A, B, each of which comprises a handle 11, 13 and a beak element 12, 14. In which a plastic threaded nut and runner mechanism D, C is provided for effecting controlled relative movement of the two components A, B. The runner C being pivotally connected to one of the handles and arranged to pass through an opening 16 in the other handle. The opening 16 is provided with inwardly extending guide formations 17, 18 that engage the runner. The runner may comprise projecting cylindrical pins for pivotal connection to a handle. A handle may be provided with a recess to receive the nut.

Description

Vaginal Speculum

Field of the Invention

This invention relates to vaginal specula and is concerned with the provision of an improved form of vaginal speculum. It is also an object of the present invention to provide a range of specula (of a number of sizes) having enhanced features to improve clinical effectiveness, patient comfort and safety, aesthetics and ergonomics.

A vaginal speculum is essentially a hand-operated medical device comprising a pair of pivotally connected components, including an upper beak and a lower beak, which are movable by means of handles between closed and open positions and are used to facilitate access to the vaginal cavity, cervix and uterus for examination and interventional clinical procedures.

Many specula at present in use are made of metal and can be reusable. The present invention is, however, more specifically concerned with the provision of an improved design of single use vaginal speculum in which the pivotally connected components are formed as plastic mouldings.

The speculum can incorporate a device such as a threaded nut and runner mechanism for holding the beaks in a desired relative position. The speculum must possess sufficient mechanical strength to retain the vaginal musculature in a desired position during the conduct of a procedure.

The beaks are inserted into the vaginal cavity in their closed position and a lubricating gel or water is typically used to facilitate more comfortable insertion of the speculum. After insertion, a gentle force is applied to open the beaks within the vaginal cavity and, if a nut and runner mechanism is included, the nut can be rotated along the thread to rest securely against the adjacent handle, thereby holding the beaks in the required open position.

It is an object of the present invention to provide a new and improved form of vaginal speculum that provides enhanced clinical effectiveness, patient comfort, aesthetics and ergonomics.

Summary of the Invention

According to the present invention there is provided a vaginal speculum comprising a pair of pivotally connected plastic components, each of which comprises a handle and a beak element, and in which a plastic threaded nut and runner mechanism is provided for effecting controlled relative movement of the two components, the runner being pivotally connected to one of the handles and arranged to pass through an opening in the other handle, which opening is provided with inwardly extending guide formations that engage the runner.

Said other handle is preferably provided with a recess surrounding the opening through which the runner passes, the nut being designed to fit in said recess.

Brief Description of the Drawings

Figure 1 is an exploded perspective view of a speculum, Figure 2 is a perspective view of the speculum, Figure 3 is a side view of the speculum, Figure 4 is a sectional view of the speculum, Figure 5 is an enlarged view of the part of the speculum high-lighted in Figure 4, Figure 6 is a perspective view of a nut which forms part of the speculum, Figure 7 comprises end and side views of the nut shown in Figure 6, Figure 8 is a perspective view of a runner which forms part of the speculum, Figure 9 comprises plan, side and end views of the runner shown in Figure 8, Figure 10 shows details of the runner slots and guides in the rear handle of the speculum, Figure 11 shows details of the runner slots and guides in the rear handle of the speculum plus the runner pivot, Figure 12 is a side view of the speculum in its closed condition illustrating the unimpeded view that is available to the user of the speculum, and Figure 13 is a side view of the speculum in its open condition, again illustrating the unimpeded view that is available to the user of the speculum.

Description of the Preferred Embodiment

The speculum shown in the drawings includes two moulded plastic components A and B, a moulded plastic threaded runner C and a moulded plastic locking nut D. The two components A and B are pivotally connected at pivot point 10. Component A comprises a handle 11 and a beak element 12, while component B comprises a handle 13 and a beak element 14. When the handles 11 and 13 are squeezed manually from their open positions, as shown in Figures 2, 3 and 5, towards their closed positions, the beak elements 12 and 14 will be opened.

The beak elements 12 and 14 blend seamlessly into the handles 11 and 13 ensuring that, on insertion of the speculum into a vagina, there is a smooth, comfortable surface in contact with the patient. This is particularly important if the speculum is rotated during insertion or when fully inserted into the vaginal cavity, thereby minimising discomfort whilst in contact with the mucosal surfaces of the vulva and the vaginal wall.

In use, the beak elements 12 and 14 are inserted into a vagina in their closed positions and then opened. Once the beak elements 12 and 14 have been opened to the required extent, they can be kept in this position by rotation of the nut D along the runner C. The nut D is designed with smooth edges for comfort and safety and has an ergonomic hexagonal grip for ease of use. The front of the nut D has a domed profile.

The runner C is rotatably mounted within the handle 13 with projecting cylindrical pins E at the end of the runner C fitting in pivot mountings 15. Between the two cylindrical pins E there is a slot F and the provision of the slot F and the flexible nature of the runner C allows for movement of the pins E towards one another to facilitate engagement of the runner C within the handle 13. Handle 11 is formed with an opening 16 through which the threaded runner C is arranged to pass and upper and lower runner guides 17 and 18 are provided within the opening 16. There is a dished recess 19 in the rear handle 11 and the nut D sits comfortably within this recess 19 when the handles 11 and 13 are in their open positions. This ensures that the nut D is located securely in position within the recess 19 when locking the beak elements 12 and 14 in their open condition.

There is a slightly larger diameter thread 20 at the end of the runner C adjacent the nut D and this end of the runner C is formed with upper and lower guide channels 21 and 22 There is a domed profile 23 at the end of the runner C (see Figures 2 and 5) and the upper and lower guides 17 and 18 within the opening 16 engage in the guide channels 21 and 22 to guide the runner C through the opening 16. This prevents the threads on the runner C catching on the edges of the opening 16 and avoids any mechanical "ratcheting" noise which could be distressing to the patient and could result in a "stop-start" action when opening and closing the beak elements 12 and 14.

The threaded runner and nut C and D are designed with a "nut retention" feature. A portion of the final turn of the runner thread has a larger profile to create an interference fit engagement with the internal thread in the nut D. The nut D is attached to the runner C by forcing it over the thicker thread thus ensuring that, in normal use, the nut D will not accidentally spin off the end of the runner C. The domed end of the runner C provides a lead-in to facilitate fitment of the nut D and provides a smooth and inherently safe shape for patient and user safety.

As can be seen from the drawings, the runner C is pivotally connected to the rear face of handle 13 and, as such, is encapsulated within the "U" section of the handle 13 and a safety feature is thereby provided in that it ensures that the threaded runner C cannot come in contact with the patient when the speculum is within the patient's vagina.

The outer surfaces of tip portions of the beak elements 12 and 14 are moulded with a precise pattern of small elliptical indents 30 with atraumatic radiused margins and these form lubricating gel pockets which are designed specifically to retain lubricating gel applied to the speculum prior to insertion in a vagina. The enhanced flow, distribution and quantity of lubricating gel serves to effect a significant reduction in patient discomfort during insertion of the speculum.

The closed edges 26 and 27 of the beak elements 12 and 14, which face one another as shown in the drawings, are located inboard of the outer elliptical beak profile 28 to avoid pinching any body tissue during use of the speculum. This is of particular importance if the speculum is rotated after insertion in a vagina.

The speculum is inserted into a vagina in the condition shown in Figure 12 and the nut D is then rotated relative to the runner C to effect closing movement of the handles 11 and 13 and simultaneous opening movement of the beak elements 12 and 14, the position of maximum opening of the beak elements 12 and 14 being shown in Figure 13. The range of line of sight of the user of the speculum is indicated by the broken lines in Figures 12 and 13 and, as can be seen from these figures, the positions and dimensions of the runner C and the nut D are such that at no time do the nut D or the runner C obstruct the user's ability to see the procedure that is being carried out.

Claims

Claims:- 1. A vaginal speculum comprising a pair of pivotally connected plastic components, each of which comprises a handle and a beak element, and in which a plastic threaded nut and runner mechanism is provided for effecting controlled relative movement of the two components, the runner being pivotally connected to one of the handles and arranged to pass through an opening in the other handle, which opening is provided with inwardly extending guide formations that engage the runner.
2. A vaginal speculum as claimed in Claim 1, in which said other handle is preferably provided with a recess surrounding the opening through which the runner passes, the nut being designed to fit in said recess.
3. A vaginal speculum as claimed in either of the preceding claims, in which the profiles of the beak elements blend seamlessly into the handles.
4. A vaginal speculum as claimed in any one of the preceding claims, in which the pivotal connection of the runner to said one of the handles is effected by means of projecting cylindrical pins at the end of the runner.
5. A vaginal speculum as claimed in any one of the preceding claims, in which the nut is of a hexagonal configuration.