GB2530918A

GB2530918A - Restraining device

Info

Publication number: GB2530918A
Application number: GB1519455.8A
Authority: GB
Inventors: Duncan Douglas Morren
Original assignee: SPLICE CAST Ltd
Current assignee: SPLICE CAST Ltd
Priority date: 2015-11-04
Filing date: 2015-11-04
Publication date: 2016-04-06
Also published as: GB201519455D0

Abstract

A restraining device provided on a medical apparatus such as a speculum 101 consists of an externally screw-threaded securing member 102 and an internally screw-threaded securing element 103. The internal thread of the securing element 103 engages with the external thread of the securing member 102 enabling the securing element 103 to move easily between a released condition and a secured condition on the securing member 102. The securing element 103 has a leading profile 105 which engages with the medical apparatus and a trailing profile 110 which is rotationally operable by a user's fingers. A boundary between the leading profile 105 and trailing profile 110 is rounded to remove sharp edges which could damage packing material, compromising sterility. Preferably the boundary is a rounded ridge 125 and preferably the device is made from plastic such as polycarbonate and is intended to be for a single use.

Description

RESTRAINING DEVICE

The present invention relates to a device for restraining an apparatus for inspecting the human or animal body. In particular, the present invention relates to a device for restraining a speculum in an open position.

Medical apparatus is known that may be restrained in a secured condition by a restraining device comprising an externally threaded securing member extending from the apparatus and an internally threaded securing element. Often the apparatus is deployed by a single clinician and it is preferable for the deployment to be executed in a smooth, unhindered manner, thereby minimising discomfort for the patient.

GB-A-2,482,348 describes a restraining device having an externally threaded securing member and an internally threaded securing element movable between a released condition and a secured condition on the securing member. The securing element has a leading profile and a trailing profile, the diameter of the trailing profile being smaller than the diameter of the leading profile.

Apparatus of this type is often of the single use variety, fabricated from plastic mouldings. Furthermore, such single use apparatus is often wrapped in a thin plastic film or paper pouch for transport and storage. The wrapping maintains sterility of the apparatus and any breach compromises that sterility and the integrity of the apparatus.

In GB-A-2,482,348 there is an immediate transition between the leading profile and trailing profile of the securing member.

This creates a sharp edge which can cut the wrapping, compromising the integrity of the apparatus.

What is needed is a securing member which can be deployed in a smooth manner but that also does not present a risk of damage to packaging material intended to maintain sterility of the apparatus.

According to the present invention there is provided a device for restraining a medical apparatus in an operating position, the device comprising: an externally threaded, elongate member securable to and extending from the apparatils; and an internally threaded securing element rotationally engageable with the elongate member and movable between a released position and a secured position in which the securing element restrains the apparatus in the operating position; wherein the securing element has & leading profile and a trailing profile, the leading profile for engaging with the apparatus when in the secured position and the trailing profile adapted to be operable by the fingers of a user; and wherein a transition between the leading profile and the trailing profile is shaped to remove sharp edges.

Advantageously, embodiments of the present invention do not present a risk of damaging material used to pack the medical apparatus which would compromise the sterility of that medical apparatus.

Preferably, a rounded ridge is provided at the transition between the leading profile and the trailing profile to remove sharp edges. This rounded ridge ensure the securing element is shaped to remove sharp edges.

A preferred embodiment of the present invention will now be described by way of an example and with reference to the accompanying drawings, in which: Figure f shows an apparatus for inspecting the human or animal body in a passive condition; Figure 2 shows the apparatus in an operational condition with a securing element in a released condition; Figure 3 shows a method of transferring a securing element from the released condition to a secured condition; Figure 4 shows the apparatus in the operational condition with the securing element in the secured condition; Figure 5 shows a side view of a prior art securing element; Figure 6 shows a side view of a securing element embodying the invention; Figure 7 shows a sectional view, taken through the line G in Figure 6, of a securing element embodying the invention; and Figure 8 shows an end view of a securing element embodying the invention.

A medical apparatus 101 for inspecting the human or animal body is illustrated in Figure 1. The example of Figure 1 is a vaginal speculum but it should be appreciated that embodiments of the invention have application to other medical inventions.

A device is provided for restraining the apparatus 101 when performing an inspection. The device consists of an externally screw-threaded securing member 102 and an internally screw-threaded securing element 103. The internal thread of the securing element 103 rotationally engages with the external thread of the securing member 102 enabling the securing element 103 to move easily between a released condition and a secured condition on the securing member 102.

Initially, upon insertion into a body cavity such as a vagina, the apparatus is in a passive condition as illustrated in Figure 1.

Having inserted the apparatus, to initiate a medical intervention or inspection, pressure is applied to a handle of the apparatus 101. As illustrated in Figure 2 this places the apparatus in its operational condition. At this point, the securing element 103 is still in its released condition and the removal of manual pressure on the handle of the apparatus 101 would result in the apparatus returning to its former passive condition.

To transfer the securing element 103 from is released condition to its secured condition, a user (typically a clinician) twists the securing element 103 in a manner substantially similar to spinning a top. This causes the securing element 103 to rotate and thereby travel down the securing member 102 in a direction indicated by arrow 301 in Figure 3.

Having twisted the securing element 103, and thereby causing it to travel in the direction indicated by arrow 301, the element 103 reaches a secured condition as illustrated in Figure 4. Pressure on the handle of the apparatus 101 can now be released and the apparatus will remain in its operational conditional. The medical intervention can now be conducted.

A securing element 500 as described in GB-A-2,482,348 is illustrated in detail in Figllre 5. A securing element 103 embodying the invention is illustrated in detail in Figures 6, 7 and 8.

The securing element 500 of Figure 5 has a leading profile 501, ensuring that the apparatus 101 is secured when the securing element has travelled to its secured condition. Tn addition, securing element 500 has a trailing profile 502 with a diameter that is smaller than the diameter of the leading profile so as to be engageable by the clinician's fingers. In this way, the rotational operation of the securing element 500 is facilitated such that it is possible to deploy sufficient rotational energy upon the securing element to ensure that it can be transferred from the released condition to the secured condition under the operation of a single twist. Consequently, the manipillation can be performed quickly and in a very smooth manner causing minimal discomfort to the patient.

The leading profile 501 is a convex leading profile and the trailing profile 502 is a concave trailing profile.

A plurality of grooves 503 are provided in the securing element 500 which extend through the leading profile 501 to the trailing profile 502. The grooves form a corresponding plurality of protrusions 504. The grooves 503 and protrusions 504 enhance gripping characteristics.

As illustrated in Figure 5, there is an immediate transition in the prior art securing element 500 between the convex leading profile 501 and the concave trailing profile 502. This results in the protrusions 504 at the boundary between the leading profile 501 and the trailing profile 502 producing a sharp edge 505. Disadvantageously, this sharp edge 505 can cut, puncture or tear any material used to wrap the apparatus 101, compromising the sterility of the apparatus.

A securing element 103 embodying the present invention is illustrated in Figures 6, 7 and 8.

As in the prior art, the securing element 103 has a leading profile 105 which engages with the medioal apparatus when the securing element has travelled to its secured condition.

Preferably, the leading profile 105 is convex to improve engagement and to help ensure that the apparatus 101 is secured.

In addition, securing element 103 has a trailing profile 110 whioh is rotationally operable by a user's fingers. The trailing profile 110 is shaped and sized to be easily engageable by a userTs fingers, preferably by being concave and having a diameter that is smaller than the diameter of the leading profile. As in the prior art, rotational operation of the securing element 103 is thereby facilitated such that the securing element 103 can be transferred from the released condition to the secured condition following a single twist by a user.

The outer perimeter of the securing element 103 is substantially circular. Optionally, a plurality of grooves 115 are provided in the securing element 103 which extend through the leading profile 105 to the trailing profile 110. The grooves 115 form a corresponding plurality of protrusions 120.

When provided, the grooves 115 and protrusions 120 enhance gripping characteristics.

In order to avoid a sharp edge at the boundary between the leading profile 105 and trailing profile 110, a rounded or beaded formation 125 is provided at the point of transition between the two profiles. This formation removes the edge found in the prior art such that the possibility of damage to any wrapping material is greatly reduced.

Preferably, the rounded formation comprises a small ridge 125 provided on the underside of the concave trailing profile 110 at the cuter perimeter of the trailing profile 110 where it meets the leading profile 105.

Where grooves 115 are provided in the securing element 103, these grooves also pass through the ridge 125. Consequently, this embodiment can alternatively be viewed as comprising a plurality of rounded ridges 125 each provided on a protrusion formed at the boundary between the leading profile 105 and the trailing profile 110. Advantageously, these ridges 125 further improve the gripping characteristics of the securing element 103.

Typically, the apparatus 101 is formed from two pieces of a suitable plastics material such as moulded polycarbonate. The two pieces are connected via a hinge. Using pclycarbonate ensures that significant manual force can be applied to the apparatus 101 to transfer it between its passive condition and its operational without risk of the apparatus breaking or cracking.

Typically, the threaded securing member 102 is also formed from polycarbonate and is moulded as an integral part of one of the two pieces of the apparatus 101. In use, the securing member 102 extends through a hole in the other of the two pieces of the apparatus 101. However, the securing member 102 may be manufactured separately from any suitable material and attached to the apparatus 101 in any suitable manner if desired.

Typically, the securing element 103 is moulded as a separate piece of polycarbonate, although it may be formed from any suitable material as desired. The internally threaded securing element 103 engages with the externally threaded securing member 102 such that, in combination, the securing element and the securing member define & restraining device.

Claims

CLAIMS1. A device for restraining a medical apparatus in an operating position, the device comprising: an externally threaded, elongate member securable to and extending from the apparatus; and an internally threaded securing element rotationally engageable with the elongate member and movable between a released position and a secured position in which the securing element restrains the apparatus in the operating position; wherein the securing element has a leading profile and a trailing profile, the leading profile for engaging with the apparatus when in the secured position and the trailing profile adapted to be operable by the fingers of a user; and wherein a transition between the leading profile and the trailing profile is shaped to remove sharp edges.
2. The device of claim 1 wherein a rounded ridge is provided at the transition between the leading profile and the trailing profile to remove sharp edges.
3. The device of claim 2 wherein the rounded ridge is provided at an outside edge of a perimeter of the trailing profile.
4. The device of claim 2 or claim 3 wherein the securing element is provided with a plurality of grooves through the trailing profile and through the rounded ridge.
5. The device of claim 4 wherein the grooves further extend through the leading profile of the securing element.
6. The device of any preceding claim wherein the leading profile is convex in shape and the trailing profile is concave in shape.
7. The device of any preceding claim wherein the device is formed from a plastics material.
8. The device of claim 7 wherein the plastics material is moulded polycarbonate.
9. A medical apparatus comprising the device of any preceding claim.
10. The apparatus of claim 9 wherein the apparatus is for inspecting the human or animal body.
11. The apparatus of claim 9 or claim 10 wherein the apparatus is a speculum.
12. The apparatus of any of claims 9 to 11 wherein the apparatus is a single use apparatus formed from a plastics material.
13. The apparatus of any of claims 9 to 12 wherein at least a part of apparatus and the elongate member are formed as a single piece of plastics material.
14. A device substantially as hereinbefore described with reference to the accompanying drawings.
15. An apparatus substantially as hereinbefore described with reference to the accompanying drawings.