GB2153684A

GB2153684A - Tampon insertion device

Info

Publication number: GB2153684A
Application number: GB08502055A
Authority: GB
Inventors: Nigel Charles Reynolds
Original assignee: Smith and Nephew Associated Companies PLC
Current assignee: Smith and Nephew PLC
Priority date: 1984-02-01
Filing date: 1985-01-28
Publication date: 1985-08-29
Also published as: GB2153684B; GB8502055D0

Abstract

A device for aiding the insertion of a tampon into a body cavity comprises an insertion tube containing a tampon towards the front end thereof and a plunger which is movable axially within the insertion tube for ejecting the tampon which insertion tube has attached to its front portion a flexible sleeve which is adapted to cover the opening at the front end of the insertion tube characterised in that the sleeve is inverted and twisted about the nose of the tampon to form a cover therefor, whereby on ejection of the tampon from the insertion tube, optionally with some rotation of the tampon, the sleeve untwists and everts to uncover the tampon. The insertion tube may have a deformable projection or projections or its inner surface.

Description

SPECIFICATION Tampon insertion device The present invention relates to a device for aiding the insertion of a tampon into a body cavity, process of forming the device and method of inserting a tampon into a body cavity employing the device.

Tampons can be inserted into a body cavity to provide a depot for a medicament or to absorb body fluids. Absorbent tampons are commonly used to absorb menstrual and other body fluids which are discharged into the vagina. When used for this purpose the absorbent tampon is preferably inserted to a position well within the vagina.

Such tampon insertion however can cause discomfort or pain. This is due in part to the absorption of moisture by the front end of the tampon from the mucous which lines the walls of the vagina and which would normally lubricate the insertion of an object into the vagina. Furthermore it is desirable that the tampon be inserted in a hygienic manner.

Devices for aiding the insertion of an absorbent tampon into a vagina which overcome some of the above problems are well known in the art. These devices normally comprise an insertion tube containing a tampon towards the front thereof and a plunger which is movable axially within the insertion tube for ejecting the tampon. A tampon can be inserted into the vagina by means of a device of this type by inserting the tube into the vagina, ejecting the tampon from the tube using the plunger and removing the insertion tube from the vagina to leave the tampon in place. The insertion tube normally has a smooth outer surface to make it more comfortable to insert into the vagina. The use of these insertion devices to position a tampon within the vagina reduces the distance the tampon has to travel in contact with the walls of the vagina thus reducing the pain or discomfort of its insertion.Furthermore these insertion devices eliminate the necessity of using a finger to insert the tampon thus enabling the tampon to be inserted in a more hygienic manner. The front open end of the insertion tube of these devices can, however scrape the wall of the vagina and collect mucous and other fluids or debris within its opening which may increase the pressure requuired to insert the tube. In addition the front open end of such devices exposes the nose of the tampon and gives the impression that the tampon is not in a hygienic condition. It would therefore be desirable to have an insertion device which has a cover for the nose of the tampon and preferably also for the front end of the insertion tube.

British Patent Specification No. 1,262,887-A5R discloses a tampon inserting device which has a thin open ended sleeve of plastic film attached to a forward portion of the insertion tube, which extends beyond the front end of the tube and which is flattened and folded back along a single line to cover the front opening and leading edge of the tube. The patent further discloses that the film of the sleeve is sufficiently thin and flexible to maintain its folded configuration without becoming permanently deformed so that ejection of the tampon through the folded portion causes it to unfold without rupturing. The folded film cover of the tampon inserting device of BP 1,262,887, however may accidentally become unfolded, prior to the device being used to insert a tampon, to expose the nose of the tampon.

A tampon insertion device has now been found in which the attached sleeve is arranged and held in position over the nose of the tampon in a more secure manner.

The present invention provides a device for aiding the insertion of a tampon into a body cavity which device comprises an insertion tube containing a tampon towards the front thereof and a plunger which is movable axially within the insertion tube for ejecting the tampon which insertion tube has attached to its front portion a flexible sleeve which is adapted to cover the opening at the front end of the insertion tube characterised in that the sleeve is inverted and is twisted about the nose of the tampon to form a cover therefor, whereby on ejection of the tampon from the insertion tube the sleeve untwists and everts to uncover the tampon.

The inverted and twisted sleeve of the device of the invention is held in position over the nose of the tampon mainly by frictional forces between, for example, adjacent portions of the sleeve, the sleeve and the tampon or the sleeve and the insertion tube. The cover over the nose of the tampon which is provided by the frictionally held sleeve of this invention is more secure to accidental opening than that provided by the simple folded sleeve of the prior art device. These frictional forces holding the sleeve in position are overcome during the ejection of the tampon from the insertion tube whereby the sleeve untwists and everts to uncover the tampon.

The sleeve used in the invention will comprise a flexible material. Naturally the flexible material of the sleeve will be biologically compatible with the membranes of the body cavity into which the sleeve will be inserted. Suitable flexible materials include flexible apertured materials such as thin bonded non-woven fabrics, however for hygienic reasons it is preferred that the flexible material is non-apertured. Preferred sleeves used in the invention therefore comprise a non-apertured flexible material such as a flexible polymer film or flexible polymer coated fabric.

Suitable polymer films for the sleeve used in the invention can be any of the water insoluble, pharmaceutically acceptable flexible films known in the art, including films of low density polyethylene, plasticised polyvinyl chloride and polyurethane.

These polymer films will suitably have a thickness of 0.006mm to 0.150mm and preferably will have a thickness of 0.012 mm to 0.075mm. Apt polymer films for the sleeve used in the invention comprise a 0.010mm to 0.030mm thick film of low density polyethylene.

Suitable flexible polymer coated materials for the sleeve used in the invention include thin bonded non-woven fabric layers coated with low density polyethylene, plasticised polyvinyl chloride or polyurethane. The thickness of the polymer coating will normally be less than 0.030mm and will preferably be between 0.005mm and 0.012mm.

As explained hereinbefore the frictional forces holding the sleeve in position over the nose of the tampon have to be overcome during the ejection of the tampon from the insertion tube to allow the sleeve to untwist and to evert to uncover the tampon. In order to reduce these frictional forces and thereby facilitate the untwisting of the sleeve it is preferred that the sleeve used in the invention comprises a lubricated flexible material. Such lubricated flexible materials will have a 'slippery surface' and therefore their use will reduce the frictional forces between the surfaces of these materials and other adjacent components of the device of the invention.

The lubricated flexible material used for the sleeve of the invention can have a lubricant incorporated into the material composition or coated on the surface of the material.

Suitable lubricant additives or coatings for the lubricated flexible material can be any of the pharmaceutically acceptable lubricants or coatings conventionally used in polymer processing as antiblocking agents or release coatings. Apt lubricant additives or coatings include silicones and organic compounds containing long chain aliphatic groups such as derivatives of fatty acids, for example stearamide and oleamide.

A favoured lubricated material for use in the sleeve of the invention comprises a 0.010mm to 0.030mm thick low density polyethylene film containing 0.1 to 1% by weight of oleamide.

Alternatively the lubricated flexible material used in the sleeve of the invention can be self-lubricating. Such materials can be made of a polymer which inherently provides a surface with a low coefficient of friction. Typical polymers of this type are fluorinated polymers such as polytetrafluoroethylene (PTFE) and fluorinated ethylene-propylene (FEP). A sleeve which comprises a film of polytetrafluoroethylene or fluorinated ethylene-propylene is a preferred aspect of the invention.

The sleeve of the device of the invention will cover and contact the nose of the tampon. The sleeve will normally have an outer portion covering the opening at the front end of the insertion tube and an inner portion which is inverted and contacts the nose of the tampon and a collapsed twisted portion between the inner and outer portions which effectively closes the opening in the sleeve. The outer portion of the sleeve may also be inverted when the nose of the tampon is within the front end of the insertion tube.

The inner inverted portion of the sleeve used in the invention can be sufficiently long to surround the tampon. When the tampon is in its preferred position inside the insertion tube with its nose projecting beyond the end of the tube, the inner inverted and outer portions of the sleeve can form a double wall cover for the nose of the tampon.

However in preferred devices of the invention the inner inverted portion of the sleeve does not surround the tampon but only contacts the nose of the tampon in order to reduce the pressure required to untwist the sleeve during ejection of the tampon from the insertion tube.

A device in which a portion of the sleeve surrounds the tampon can advantageously have means to aid the untwisting of the closed sleeve during ejection of the tampon from the insertion tube as described hereafter.

The sleeve used in the invention will be attached to the front portion of the insertion tube. The sleeve can be attached to the outside, the inside or the end of the front portion of the insertion tube.

Normally and preferably the sleeve will be attached to the outside of the front portion of the tube. Such an attachment will allow the sleeve to cover the leading edge of the tube during its insertion into a body cavity and thus reduce the possibility of these edges scraping the walls of the body cavity.

The sleeve used in the invention, depending on its nature, can be attached to the insertion tube by any convenient method which includes heat sealing, adhesive bonding or simple friction fit. The attachment should be strong enough to prevent the sleeve being detached from the insertion tube during manufacture of the device, ejection of the tampon or withdrawal of the insertion tube from the body cavity.

The sleeve used in the invention will have a portion which can extend beyond the front end of the insertion tube. This extended portion of the sleeve is adapted to allow the passage of a tampon and also to cover and close the opening at the front end of the insertion tube.

The length of the extended portion of the sleeve must be sufficient to enable the sleeve to close the opening at the front end of the insertion tube. The minimum length of the extended portion of the sleeve will therefore be greater than the radius of the opening and will preferably be greater than the diameter of the opening at the front end of the insertion tube. It is preferred that the length of the extended portion of the sleeve is less than the length of the tampon so that the tampon projects beyond the end of the sleeve when it is ejected from the insertion tube. The maximum length of the extended portion of the sleeve therefore will preferably be less than that of the tampon.

The absorbent tampons used in the invention will usually have a length of 40mm to 50mm and a maximum cross-section of lOmm to 18mm. The size of the opening at the front end of the insertion tube will normally be similar to that of the tampon cross-section. The extended portion of the sleeve used in the invention can therefore suitably have a length of 15 to 40mm and preferably have a length of 20mm to 30mm. The diameter of the sleeve can be from lOmm to 20mm.

The insertion tube used in the invention should have sufficient structural strength and rigidity and preferably also have sufficient resistance to water and aqueous body fluids to prevent collapse during its insertion into the body cavity such as the vagina. Desirably the insertion tube has also a smooth surface to aid insertion.

Suitable insertion tube can be made of paper, cardboard or a plastics material. The paper or cardboard is preferably coated with a wax or water insoluble polymer to render it water resistant. Suitable plastics materials include polyolefines such as high density polyethylene or polypropylene.

The plunger used in the invention can suitably be a hollow tube which will slide telescopically inside the insertion tube. The plunger can be made of the same materials as described hereinbefore in relation to the insertion tube.

It is desirable that both plunger and insertion tube are made of pharmaceutically acceptable materials.

The tampon used in the invention can be any of the medicated or absorbent tampons which are commonly inserted into a body cavity. The absorbent tampon can comprise an absorbent fibre or foam structure which is preferably compressed into a compact self sustaining form. The front end or nose of the tampon will usually have a smooth round surface to aid insertion of the tampon into the body cavity. Normally the tampon will have a withdrawal cord attached to and preferably stored within its rear end. The tampon may also have a series of parallel grooves along its length to enable it to expand in a regular manner over its width inside the vagina.

In the device of the invention the tampon will be inside and towards the front of the insertion tube.

Preferably the nose of the tampon projects beyond the front end of the insertion tube so that the front end of the device presents an smooth round surface during its insertion into the body cavity.

In favoured embodiments of the invention the device will have means which will cause the tampon to rotate during its ejection from the insertion tube to aid the untwisting of the twisted sleeve cover and to uncover the tampon.

Accordingly in another aspect of the device of the invention the outer surface of the tampon has means which can cooperate with means on the inner surface of the insertion tube to cause the tampon to rotate about its longitudinal axis during its ejection from the insertion tube.

Suitable cooperating means include helical grooves or ribs on one surface cooperating with similar helical grooves or ribs or a projection or indentation on the other surface.

Alternatively the device can have means which will cause the plunger to rotate which in turn can have means to transfer the rotation to the tampon during its ejection from the insertion tube. Accordingly in yet another aspect of the device of the invention the outer surface of the plunger has means which can cooperate with means on the inner surface of the insertion tube to cause the plunger to rotate when moved axially inside the tube which plunger also has means at its front end which can cooperate with means at the rear end portion of the tampon to transfer the axial rotation to the tampon.

Suitable cooperating means to cause rotation of the plunger are those means hereinbefore described in relation to the applicator and tampon.

Suitable cooperating means between the plunger and the tampon include projections on the front end of the plunger which can project into the rear end of the tampon or can cooperate with the indentations at the rear end portion of the tampon.

Advantageously the device of the invention can be within a bacteria proof pack for example a plastics or paper pouch and made sterile by conventional sterilising methods such as gamma or electron irradiation, ethylene oxide gas or steam autoclaving. The use of such a sterile device can reduce the chance of causing an infection in the body cavity by insertion of a tampon therein.

In yet another aspect the invention provides a method of inserting a tampon into a body cavity which method employs a device which comprises an insertion tube containing a tampon towards the front thereof and a plunger which is movable axially within the insertion tube for ejecting the tampon which insertion tube has attached to its front portion a flexible sleeve which is adapted to cover the opening at the front end of the insertion tube characterised in that the sleeve is inverted and twisted about the nose of the tampon to form a cover therefor whereby on ejection of the tampon from the insertion tube the sleeve untwists and everts to uncover the tampon.

In the method of the invention the insertion tube of the device is inserted into a body cavity, the tampon ejected from the insertion tube by means of the plunger and the insertion tube removed from the body cavity. The attached sleeve provides a cover for the nose of the tampon. Preferably the nose of the tampon projects beyond the front end of the insertion tube of the device used in the method of the invention so that the sleeve cover over the nose of the tampon has a rounded shape to aid insertion of the tube into the body cavity.

The portion of the sleeve which can extend beyond the front end of the insertion tube of the device used in the method of the invention is also preferably shorter than the length of the tampon so that a portion of the tampon ejected from the insertion tube can be gripped by the walls of the body cavity to allow the tampon to remain in position when the insertion tube is withdrawn.

In a further aspect the invention provides a process of forming the device of the invention which comprises inserting a tampon into an insertion tube which has a sleeve attached to and inverted within its front portion so that the nose of the tampon faces the front end of the insertion tube and the inverted sleeve surrounds the tampon and rotating the tampon along its longitudinal axis to cause the inverted sleeve to twist and cover the nose of the tampon.

In the process of the invention the twisting of the inverted sleeve normally reduces the length of the portion of the sleeve surrounding the tampon. In a process of forming a preferred device of the invention the twisting of the inverted sleeve reduces the length of the portion of the sleeve surrounding to tampon to zero so that the inner portion of the sleeve covers only the nose of the tampon.

Preferably the tampon is partially ejected from the insertion tube during the rotation process so that the nose of the tampon projects from the front end of the tube. The tampon can be rotated by a suitable tool, for example driven machine tool or by a plunger which has projections which can cooperate with the rear portion of the tampon as hereinbefore described.

The insertion tube can have a projection or projections on its inner surface to limit the distance into which the tampon can be inserted into the tube during the manufacturing process. Such a projection or projections should be deformable to allow the plunger to eject the tampon from the insertion tube.

The invention will now be illustrated by reference to the following drawings: Figure 1 shows a cross-section of a device of the invention.

Figure 2 shows an enlarged cross-section of the front end portion of the device of Figure 1.

Figure 3 shows a cross-section of the device of Figure 1 with the tampon partially ejected from the insertion tube.

The device (1) shown in Figure 1 has an insertion tube (2) containing a tampon (3) towards its front and a hollow tubular plunger (4) which is movable axially in a telescopic sliding manner within the insertion tube (1) in a direction shown by arrow (A) for ejecting the tampon (3). Tampon (3) has a withdrawal thread (5) attached at its rear end. The insertion tube has a flexible sleeve (6) attached to the outside of its front portion (7) by adhesive layer (8). The portion of the sleeve (6) which can extend beyond the front end of the insertion tube (2) is inverted and twisted about the nose (9) of the tampon (3) to form a cover therefor. Tampon (3) is shown in Figure 1 with its nose (9) projecting slightly beyond the front end of the insertion tube (10).Sleeve (6) shown more clearly in Figure 2 has an inverted portion (11) adjacent to the nose (9) of the tampon (3), an outer portion (12) which overlies the inverted portion (11) and a twisted collapsed portion (13) between portion (11) and (12) which effectively closes the sleeve (6). The inverted and twisted sleeve (6) has shown in Figures 1 and 2 can provide relatively smooth cover for the nose (9) of the tampon (3) to facilitate insertion of the tampon into a body cavity.

In Figure 3 the tampon (3) is shown partially ejected from the insertion tube (2) with its nose projecting beyond the end of the sleeve (6) which has untwisted and everted during ejection of the tampon.

When used to insert a tampon into a body cavity such as the vagina, the insertion tube of the device is partially or wholly inserted into the body cavity, the tampon ejected from the insertion tube and attached sleeve removed from the body cavity. During the withdrawal of the insertion tube the wall of the body cavity grips the portion of the tampon which projects beyond the end of the sleeve and thus causes the tampon to remain in place during the withdrawal.

Claims

1. A device for aiding the insertion of a tampon into a body cavity which device comprises an insertion tube containing a tampon towards the front thereof and a plunger which is movable axially within the insertion tube for ejecting the tampon which insertion tube has attached to its front portion a flexible sleeve which is adapted to cover the opening at the front end of the insertion tube characterised in that the sleeve is inverted and twisted about the nose of the tampon to form a cover therefor, whereby on ejection of the tampon from the insertion tube the sleeve untwists and everts to uncover the tampon.

2. A device as claimed in claim 1 in which the sleeve comprises a flexible polymer film.

3. A device as claimed in claim 2 in which the flexible polymer film is a low density polyethylene film.

4. A device as claimed in any of claims 1 to 3 in which the sleeve is attached to the outside of the front portion of the insertion tube.

5. A device as claimed in any of claims 1 to 4 in which a portion of the sleeve surrounds the tampon.

6. A device as claimed in any of claims 1 to 5 which has a means to cause the tampon to rotate during its ejection from the insertion tube to aid the untwisting of the twisted sleeve cover.

7. A device as claimed in any of claims 1 to 6 in which the nose of the tampon projects beyond the front end of the insertion tube.

8. A sterile device of claims 1 to 7 within a bacteria proof pack.

9. A process of forming the device as claimed in claims 1 to 8 which comprises inserting a tampon into an insertion tube which has a sleeve attached to and inverted within its front portion so that the nose of the tampon faces the front end of the insertion tube and the inverted sleeve surrounds the tampon and rotating the tampon along its longitudinal axis to cause the inverted sleeve to twist and cover the nose of the tampon.

10. A method of inserting a tampon into a body cavity employing the device as claimed in claims 1 to 8.