WO2013131839A1

WO2013131839A1 - Medical device

Info

Publication number: WO2013131839A1
Application number: PCT/EP2013/054239
Authority: WO
Inventors: Richard William JOHN; Gillian John
Original assignee: John Richard William; Gillian John
Priority date: 2012-03-05
Filing date: 2013-03-04
Publication date: 2013-09-12
Also published as: GB201203768D0

Abstract

A medical device, such as a vaginal acceptance trainer, is made substantially of a flexible material which allows the device to flex with body movement and includes an elongate primary portion (1) and a secondary portion (3, 5) provided at an end of the primary portion. A necked portion (6) of reduced diameter compared with that of the primary is formed between the primary portion and the secondary portion. The primary portion, the necked portion, and the end portion are all externally formed to form smooth curves where they adjoin and at the free ends thereof.

Description

MEDICAL DEVICE

This invention relates to a medical device and more particularly relates to a vaginal acceptance trainer which can be used for training of the external and internal vaginal area to accept future insertions of different types.

Vaginal tightness can result from a number of conditions and can give rise to difficulties because it renders external and internal vaginal examination, as well as insertion into and penetration of the vagina, difficult or impossible.

Treatment with dilators is known, but these are rigid devices which can only be used for a few minutes at a time. Consequently, the time required for treatment to be effective can be very considerable.

It is therefore an object of the present invention to provide a medical device which overcomes, or at least ameliorates the above-described problem.

According to the present invention there is provided a medical device made substantially of a flexible material and comprising an elongate primary portion and a secondary portion provided at an end of the primary portion, a necked portion of reduced diameter compared with that of the primary being formed between the primary portion and the secondary portion, the primary portion, the necked portion, and the end portion all being externally formed to form smooth curves where they adjoin and at the free ends thereof.

The flexible material allows the device to flex with body movement.

The device may have a specific gravity less than 1 such that it floats in water.

The primary portion may comprise a plurality, for example two or three or more, bulbous sub-portions, each separated by a necked sub-portion. The surfaces of the bulbous portions and the intervening necked portion(s) may form a sine wave in the axial direction of the device. A sleeve may be provided over the bulbous sub-portions to convert the primary portion to a cylindrical form. Alternatively, the primary portion may be substantially cylindrical.

The secondary portion may be substantially spherical. Alternatively, the secondary portion may be substantially pear-shaped having a tapered region and a rounded region, the pear-shaped portion being joined to the primary portion at the tapered portion of the pear-shaped portion. The secondary portion may be provided with retrieval means, such as one or more holes or a retrieval loop.

The secondary portion may be provided only at one end of the primary portion. Alternatively, the secondary portion may be provided at each end of the primary portion. Each secondary portion may be identical. Alternatively, one secondary portion may be substantially spherical and the other secondary portion may be substantially pear shaped as defined above.

The surface of the device may be substantially smooth. Alternatively, the surface may be textured, such as ribbed or patterned. The surface may be fluorescent or luminescent.

A resilient ring may be removably provided around the or at least one of the necked portions in order to increase the overall diameter of the device.

The device may comprise a vaginal acceptance trainer.

The device may be in modular form. The secondary portion or portions may be removable from the primary portion, for example using a male portion on one of the components and a complementary female portion on the other of the components. The components may be a snap fit, or they may be threaded. Moreover, the primary portion may also be in modular form, allowing one or more of the bulbous sub-portions to be secured end-to-end in order to vary the length of the device, or allowing bulbous sub-portions of different configuration to be used, such as substantially cylindrical portions (with rounded end regions) or curved portions, such as forming a surface in the form of a sine wave.

The invention also relates to a kit comprising three devices as hereinbefore defined, a first of the devices having a substantially cylindrical primary portion, a second of the devices having at least three bulbous sub-portions each separated by a necked sub-portion, and a third of the devices having two bulbous sub-portions separated by a necked sub-portion.

The first device may have a first maximum diameter, the second device may have a second maximum diameter less than the first maximum diameter, and the third device may have a third maximum diameter less than the second maximum diameter.

It has been found that the flexible nature of the device allows it to be used for extended periods, for example overnight, as well as for somewhat shorter periods at other times of the day, such as when resting or becoming familiar with the device. The device can be used in the field of gynecology as well as in association with neuro-linguistic programming and/or cognitive behavioural therapy and/or hypnosis.

For a better understanding of the present invention and to show more clearly how it may be carried into effect reference will now be made, by way of example, to the accompanying drawings in which:

Figure 1 shows one embodiment of a medical device in the form of a vaginal acceptance trainer according to the present invention;

Figure 2 is a cross-sectional view of the device shown in Figure 1;

Figure 3 shows another embodiment of a medical device in the form of a vaginal acceptance trainer according to the present invention; and

Figure 4 shows a further embodiment of a medical device in the form of a vaginal acceptance trainer according to the present invention.

The vaginal acceptance trainer shown in Figure 1 is made of a flexible material, such as medical grade silicone material, which allows the device to flex with body movement. Alternatively, the device may be made of a rubber material or a (closed cell) foam material, which may or may not be of a medical grade. The material may have a Shore A hardness in the range from 5 to 90, preferably in the range from 10 to 50 and most preferably in the range from 30 to 40. If desired, the device could have a specific gravity less than 1 such that it floats in water.

As shown in Figure 1 the device comprises a primary elongate bulbous portion 1 which in Figure 1 is substantially cylindrical. The primary portion 1 may have a diameter of, for example, of about 17.5 mm and is joined at one end to a first secondary portion 3 in the form of a substantially spherical portion and at the other end to a second secondary portion 5 in the form of a substantially pear-shaped portion having a tapered region and a rounded region, the pear-shaped portion being joined to the primary cylindrical portion at the tapered portion of the pear-shaped portion 5. The primary cylindrical portion 1 is joined in each case to the spherical portion 3 and the pear-shaped portion 5 by way of a necked portion 6 of reduced diameter compared with that of the primary cylindrical portion 1 (for example about 13.75 mm between the primary portion and the spherical portion and about 12.5 mm between the primary portion and the pear-shaped portion), the primary cylindrical portion, necked portion, spherical portion and pear-shaped portion all being externally formed to form smooth curves where they adjoin and at the free ends thereof. A hole 7 is formed in the spherical portion 3 in a region thereof remote from the primary cylindrical portion 1 and a hole 9 is formed in the pear-shaped portion 5, also in a region thereof remote from the primary cylindrical portion 1. The holes 7 and 9 serve for retrieval purposes and may be omitted if desired. As an alternative to the holes 7, 9, a pair of diametrically spaced holes (not shown) may be provided in each end piece or a retrieval loop (not shown) may be provided. The maximum diameters of the portions 3 and 5 are substantially the same as the diameter of the primary portion 1, although a different diameter (for example a smaller diameter) is also possible. The overall length of the device is about 120 to 130 mm, preferably about 127 mm, with the primary portion having a length of about 76 mm and the end portions each being of a similar length to each other.

If desired, only one of the end portions 3, 5 may be provided. That is, the primary portion 1 may be provided with either the spherical end portion 3 or with the pear-shaped end portion 5. If appropriate, the device may therefore be made in two forms, one form with each of the end portions.

The surface of the illustrated device is substantially smooth. However, if desired, the surface may be textured, such as ribbed or patterned. If desired the surface could be fluorescent or luminescent.

As shown in Figure 2, the device may be hollow, at least in the region of the primary cylindrical portion 1, although the portions 3 and 5 may also be hollow if desired. If hollow, the device may be adapted to be inflatable. Alternatively, the primary cylindrical portion and, if appropriate, the portions 3 and 5 may be filled with a suitable material, such as a foam or a fluid, or may be formed with internal structural components, such as struts, to determine the properties of the device. When filled with a fluid, a plug (not shown) may be provided to allow the fluid to be drained and replaced.

In use of the device, it may be inserted into the vagina such that one of the end portions and the primary cylindrical portion are within the vagina and the other end portion is positioned at the vaginal opening. In this way the device can be used to train the internal vaginal area, the vaginal opening and the external vaginal area. The user may choose whether the spherical end portion 3 or the pear-shaped end portion 5 is to be inserted. The device may be re-usable or may be disposable after use.

The vaginal acceptance trainer shown in Figure 3 is similar to that shown in Figures 1 and/or 2 and the same references are used to denote the same or similar features. Only the differences will be explained in detail. In this case, the primary portion 1 comprises three bulbous sub-portions 11, 13, 15 (although a greater number of bulbous portions may be provided if desired) each separated by a necked sub-portion 17, 19. The surfaces of the bulbous portions and the intervening necked portions may resemble a sine wave in the axial direction of the device. The bulbous sub-portions 11, 13, 15 and the end portions 3, 5 may have a maximum diameter of about 15 mm, with the device having an overall length of about 120 to 130 mm, preferably about 127 mm, with the primary portion having a length of about 76 mm and the end portions each being of a similar length to each other. That is, the peaks of the bulbous portions are spaced by about 25 mm. The diameter of the necked portions 6 and of the necked sub-portions 17, 19 is about 10 mm.

The vaginal acceptance trainer shown in Figure 4 is similar to that shown in Figure 3 and the same references are used to denote the same or similar features. Only the differences will be explained in detail. In this case, the primary portion 1 comprises two bulbous sub-portions 21, 23 separated by a necked sub-portion 25. The surfaces of the bulbous portions and the intervening necked portion may resemble a sine wave in the axial direction of the device. The bulbous sub-portions may have a maximum diameter of about 12.5 mm, with the device having an overall length of about 100 to 110 mm, preferably about 102 mm, with the primary portion having a length of about 51 mm and the end portions each being of a similar length to each other. That is, the peaks of the bulbous portions may be spaced by about 25 mm. The diameter of the necked portions 6 and of the necked sub-portion 25 may be about 7.5 mm.

Use of the devices of Figures 3 and 4 is essentially the same as for the device of Figures 1 and/or 2 except the bulbous sub-portions allow for intermediate insertion points allowing for controlled insertion by the user and giving the user control over the depth of insertion.

The devices of Figures 3 and 4 may be modified by providing a sleeve (not shown) over the bulbous portions in order to convert the device of Figure 3 and/or 4 into a device substantially the same as that shown in Figures 1 and/or 2.

One of the devices may be employed individually. Alternatively, the three devices may be provided as a kit such that the user can begin with the smallest device of Figure 4 and then progress through the intermediate device of Figure 3 to the largest device of Figure 1 and/or 2.

The device may be modified in a number of ways. For example, the size of the device may be changed to allow it to be inserted into other body openings, such as the ear, nose, mouth or rectum. It follows that the device may be used for purposes other than vaginal acceptance training. A removable resilient ring may be provided, dimensioned to fit in one or more of the necked portions 6, 17, 19, 25 in order to increase the overall diameter of the device.

Moreover, the device may be made in modular form. For example, the secondary portion or portions may be removable from the primary portion, for example using a male portion on one of the components and a complementary female portion on the other of the components. Ideally the interconnecting components are also made of flexible material, but alternatively they may be made of a rigid material because this does not significantly affect the overall flexibility of the device. The components may be a snap fit, or they may be threaded. Moreover, the primary portion may also be in modular form, allowing one or more of the bulbous sub-portions to be secured end-to-end in order to vary the length of the device, or allowing bulbous sub-portions of different configuration to be used, such as substantially cylindrical portions (with rounded end regions) or curved portions, such as in the form of a sine wave. If a ring is used around one or more of the necked portions, it is not essential, although still preferable, for the ring to be resilient, or at least sufficiently resilient to pass over end regions of the device. This is because the components of the device can be separated and reassembled with the ring being added or removed.

Claims

A medical device made substantially of a flexible material and comprising an elongate primary portion (1) and a secondary portion (3, 5) provided at an end of the primary portion, a necked portion (6) of reduced diameter compared with that of the primary being formed between the primary portion and the secondary portion, the primary portion, the necked portion, and the end portion all being externally formed to form smooth curves where they adjoin and at the free ends thereof.
A device as claimed in claim 1 and having a specific gravity less than 1.
A device as claimed in claim 1 or 2, wherein the primary portion (1) comprises a plurality of bulbous sub-portions (11, 13, 15, 21, 23), each separated by a necked sub-portion (17, 19, 25).
A device as claimed in claim 3 and including at least three bulbous sub-portions (11, 13, 15).
A device as claimed in claim 3 or 4, wherein the surfaces of the bulbous portions (11, 13, 15, 21, 23) and the intervening necked portion(s) (17, 19, 25) form a sine wave in an axial direction of the device.
A device as claimed in claim 3, 4 or 5, wherein a sleeve is provided over the bulbous sub-portions (11, 13, 15, 21, 23) to convert the primary portion (1) to a cylindrical form.
A device as claimed in claim 1 or 2, wherein the primary portion (1) is substantially cylindrical.
A device as claimed in any preceding claim, wherein the secondary portion (3) is substantially spherical.
A device as claimed in any one of claims 1 to 7, wherein the secondary portion (5) is substantially pear-shaped having a tapered region and a rounded region, the pear-shaped portion being joined to the primary portion at the tapered portion of the pear-shaped portion.
A device as claimed in any preceding claim, wherein the secondary portion (3, 5) is provided with retrieval means (7, 9).
A device as claimed in claim 10, wherein the retrieval means (7, 9) comprises one or more holes.
A device as claimed in claim 10, wherein the retrieval means comprises a retrieval loop.
A device as claimed in any preceding claim, wherein the secondary portion (3, 5) is provided only at one end of the primary portion (1).
A device as claimed in any one of claims 1 to 12, wherein the secondary portion (3, 5) is provided at each end of the primary portion (1).
A device as claimed in claim 14, wherein each secondary portion (3, 5) is identical.
A device as claimed in claim 14, wherein one secondary portion (3) is substantially spherical and the other secondary portion (5) is substantially pear shaped having a tapered region and a rounded region, the pear-shaped portion being joined to the primary portion (1) at the tapered portion of the pear-shaped portion.
A device as claimed in any preceding claim, wherein the surface of the device is substantially smooth.
A device as claimed in any one of claims 1 to 16, wherein the surface of the device is textured.
A device as claimed in claim 18, wherein the surface of the device is ribbed or patterned.
A device as claimed in any preceding claim, wherein the surface of the device is fluorescent or luminescent.
A device as claimed in any preceding claim, wherein a resilient ring is removably provided around the or at least one of the necked portions (6, 17, 19, 25) in order to increase the overall diameter of the device.
A device as claimed in any preceding claim in the form of a vaginal acceptance trainer.
A device as claimed in any preceding claim, wherein the device is in modular form.
A device as claimed in claim 23, wherein the or each secondary portion (3, 5) is removable from the primary portion (1).
A device as claimed in claim 24, wherein a male portion is provided on one of the components and a complementary female portion is provided on the other of the components.
A device as claimed in claim 24 or 25, wherein the components are a snap fit.
A device as claimed in claim 24 or 25, wherein the components are threaded.
A device as claimed in any one of claims 23 to 27, wherein the primary portion (1) is in modular form.
A kit comprising three devices as claimed in any preceding claim, a first of the devices having a substantially cylindrical primary portion (1), a second of the devices having at least three bulbous sub-portions (11, 13, 15) each separated by a necked sub-portion (17, 19), and a third of the devices having two bulbous sub-portions (21, 23) separated by a necked sub-portion (25).
A kit as claimed in claim 29, wherein the first device has a first maximum diameter, the second device has a second maximum diameter less than the first maximum diameter, and the third device has a third maximum diameter less than the second maximum diameter.