EP4731139A1

EP4731139A1 - Anal insert and method of preparing an anal insert

Info

Publication number: EP4731139A1
Application number: EP24738215.3A
Authority: EP
Inventors: Chaban BOUGHERARA
Original assignee: Coloplast AS
Current assignee: Coloplast AS
Priority date: 2023-06-21
Filing date: 2024-06-21
Publication date: 2026-04-29
Also published as: CN121398768A; WO2024260527A1

Abstract

An anal insert comprising a dry foam material, where the foam material is compressed to a smaller volume than when uncompressed. The foam comprises water soluble synthetic or natural polymer being distributed evenly in the foam material and the foam material remains in compressed configuration until wetted. The anal insert may be suitable for an anal plug or closure or for use with an anal irrigation probe.

Description

ANAL INSERT AND METHOD OF PREPARING AN ANAL INSERT

The invention relates to an anal insert for insertion into an artificial or an incontinent natural intestinal opening.

One aspect of the disclosure provides an anal insert in accordance with the appended claim 1. Another aspect of the disclosure provides a method for preparing an anal insert in accordance with the appended claim 12.

Brief Description of the Drawings

The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The figures illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. Like reference numerals designate corresponding similar parts.

Figure 1 illustrates one embodiment of the invention in a non-compressed configuration.

Figure 2 illustrates the embodiment of Figure 1 in a compressed configuration.

Figure 3 illustrates an embodiment of the invention comprising a sleeve.

Figure 4 illustrates another embodiment of the invention, where the anal insert is used with an anal probe. Detailed Description

In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized, and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.

The use of the phrase "substantially" as a qualifier to certain features or effects in this disclosure is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.

From US4981465 is known an anal closure comprising a compressed foam material being held in shape by a wrapping a layer of polyvinyl alcohol (PVA) around the surface.

In one aspect, the present disclosure relates to an anal insert comprising a dry foam material, where the foam material has in a compressed configuration a smaller volume than when in an uncompressed configuration, and wherein the foam material comprises a water soluble synthetic or natural polymer evenly distributed in the foam material.

The anal insert may remain in the compressed configuration until exposed to moisture or wetted, being form-stable in dry state. The content of the water soluble synthetic or natural polymer may act as a glue; by "locking" the shape of the foam material that it is dried in, such as in a compressed configuration. When the foam material is exposed to moisture or wetted, the water soluble synthetic or natural polymer is dissolved, and thereby the foam is released and begins to expand towards its uncompressed configuration. Fully wetted, the foam material may reach a non-compressed configuration in an unrestricted space. In case the anal inset is inserted into a restricted space, the foam may expand to fill the restricted space.

By non-compressed configuration is herein meant a state where the foam material is not influenced by external compressive forces. By compressed is herein meant that the volume of the compressed foam material is smaller than the volume of the noncompressed foam material.

In embodiments, the foam is hydrophilic. In embodiments, the foam material is a polyurethane foam.

In embodiments, the foam material is impregnated with a water soluble synthetic or natural polymer. In embodiments, the water soluble synthetic or natural polymer comprises polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), gelatine, cellulose, starch, a water soluble poly-oxy-alkylene, or mixtures thereof. In embodiments, the water soluble synthetic or natural polymer is incorporated in the foam material during the production of the foam. The water soluble synthetic or natural polymer is evenly distributed in the foam material. In embodiments, the water-soluble poly-oxy-alkylene has a glass transition temperature from 20 C to 70 C, such as from 30 C to 70 C, such as from 37 C to 50 C.

In embodiments, the water soluble synthetic or natural polymer is present in the foam material in an amount of less than 10% w/w, such as at less than 7% w/w or even at less than 5% w/w.

In embodiments, the foam material expands to uncompressed configuration when wetted/exposed to moisture. In embodiments, the foam material will expand to original volume when exposed to moisture/water.

In embodiments, the expansion of volume of the foam material from compressed to non-compressed configuration is at least 50%, such as at least 100% or even 200%. In embodiments, the anal insert is in the form of a disposable closure for an artificial or an incontinent natural intestinal opening. In embodiments, the anal insert is an anal plug. The plug may be provided with a handle. Such handle may be in the form of a withdrawal strap.

In embodiments, the closure or plug is a substantially cylindrical, conical, or bellshaped structure having a cross-sectional area, measured halfway between its ends, of at least the double of the cross-sectional area of the intestinal duct for which it is intended.

When supplied by the manufacturer, this anal insert may be compressed to a substantially cylindrical shape having a cross-sectional area as or slightly below that of the intestinal duct in question. The anal insert is maintained in that compressed configuration by the incorporated content of water soluble synthetic or natural polymer. The shape-maintaining effect is rapidly eliminated upon contact with the moisture content of the intestine of the human body.

In embodiments, the anal insert is a retention part of an anal probe. The retention part is compressed to a small volume around the anal probe before use. When the probe is inserted, the foam material will absorb moisture and the foam will decompress into a wider shape that helps the probe to stay in place. The anal insert may e.g., have the shape of a dome, disc, or a funnel.

In embodiments, the anal insert comprises a sleeve that is removed before use. The sleeve may serve to keep the insert compressed during drying and/or during storage.

In embodiments, the sleeve is rigid/form stable in the sense that it is able to hold the foam in the compressed configuration. In embodiments, the sleeve may comprise polymeric material or cardboard material. The sleeve may comprise multiple holes or slits. The holes allow moisture to evaporate from the foam material. In embodiments, the sleeve has a substantially cylindrical/tubular shape. In aspects, the present disclosure relates to a method of preparing an anal insert, comprising the steps of: a. providing a wetted foam material comprising a water soluble synthetic or natural polymer distributed evenly in the foam material, b. compressing the wet foam material to a desired compressed configuration with a smaller volume than in the uncompressed volume of the foam material, c. drying the foam material in the compressed configuration.

In embodiments, the foam is wetted before step a. by dipping the foam material in a solution of a water soluble synthetic or natural polymer.

By distributing the water soluble synthetic or natural polymer evenly in the foam material, a production step can be spared as the dried, compressed foam will stay in the compressed shape until wetted, whereas a foam material without the water soluble synthetic or natural polymer will expand to original volume as soon as the external compressive forces are removed - unless it is provided with restraining means such as a wrapping of water-soluble material that holds it in place. Providing the anal insert with such wrapping add a cost- and time-consuming extra step to the production of the anal insert.

In embodiments, the wet foam material is dried in a mould the keeps the foam material in the compressed configuration. When the foam material is dried, the anal insert may be removed from the mould.

In embodiments, the method further comprises the step of providing the compressed foam material with a sleeve prior to drying. The compressed wet foam material may be placed in a sleeve and dried there. In embodiments, the anal insert is kept in the sleeve until use.

In embodiments, the sleeve is provided with multiple holes or slits/apertures. This allows the moisture to evaporate from the compressed foam material during drying of the anal insert. The sleeve may be removed after drying of the foam material or it may stay on until use, serving as a protection layer. The sleeve is removed before insertion into the body.

In embodiments, the anal insert is a closure device for insertion into externally debouching, artificial or natural body canals of animal or human beings. It may comprise a resilient compressible plug-like body of moulded foam material, which body when inserted absorbs moisture and expands to a cross-sectional dimension ensuring closure of the body cavity (canal) in question. For withdrawal of the anal insert from the body cavity, it may be provided with a handle means extending from the anal insert and outside the body cavity during use, thereby allowing the user to grip the handle and withdraw the anal insert. In embodiments, the handle maybe in the form of a string, cord or a gauze/knitted structure.

The outer geometrical form and size of the anal insert will of course depend on the purpose of application and in which body canal it is to be used.

Expansions measured by the diameter of the anal insert may lie within the area of 50- 400% depending on the character and the application field of the material.

Detailed description of the drawings

Various exemplary embodiments and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and may be practiced in any other embodiments even if not so illustrated, or if not so explicitly described. Figure 1 is showing an embodiment of an anal insert (10) with handle means (20). The anal insert comprises a foam material wherein water soluble synthetic or natural polymer is evenly distributed in the foam. The anal insert (10) is in non-compressed configuration. The anal insert (10) comprises a resilient foam material and has a substantially conical/bell shaped appearance.

In Figure 2 is shown the same embodiment of the anal insert (10), but in compressed state.

In Figure 3 is shown a compressed anal insert (10) in a sleeve (30). The sleeve (30) is provided with holes (40).

In figure 4 is shown an embodiment of the anal insert (10) where it is a part of an anal probe (50) for irrigation. The anal insert (10) serves as a retention means for the anal probe (50). The figure shows an uncompressed anal insert (10) in a dome-shaped configuration.

Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of anal inserts as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.

Embodiments, and features of the various exemplary embodiments described in this application, may be combined with each other ("mixed and matched"), unless specifically noted otherwise.

Claims

CLAIMS:

1. An anal insert comprising a dry foam material, wherein the foam material has in a compressed configuration a smaller volume than when in an uncompressed configuration, and wherein the foam material comprises a water soluble synthetic or natural polymer evenly distributed in the foam material.

2. The anal insert according to claim 1, wherein the foam material expands to its uncompressed configuration when exposed to moisture.

3. The anal insert according to claim 1 or 2, wherein the water soluble synthetic or natural polymer comprises polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), gelatine, cellulose, starch, a water-soluble poly-oxy-alkylene, or mixtures thereof.

4. The anal insert according to any of the preceding claims, wherein the foam material is impregnated with the water soluble synthetic or natural polymer.

5. The anal insert according to any of the preceding claims, wherein the foam material is configured to remain in compressed configuration until exposed to moisture.

6. The anal insert according to any of the preceding claims, wherein the anal insert is an anal plug.

7. The anal insert according to any of the preceding claims, wherein the anal insert is provided with a handle.

8. The anal insert according to any of the preceding claims, wherein the anal insert is a retention part of an anal probe.

9. The anal insert according to any of the preceding claims, wherein the foam material comprises a polyurethane foam.

10. The anal insert according to any of the preceding claims, wherein the anal insert comprises a sleeve.

11. The anal insert according to claim 10, wherein the sleeve is rigid.

12. A method of preparing an anal insert, comprising the steps of: a. providing a wetted foam material comprising a water soluble synthetic or natural polymer being evenly distributed in the foam material, b. compressing the foam material into a desired compressed configuration with a smaller volume than the uncompressed configuration, c. drying the foam material in the compressed configuration.

13. The method according to claim 12, comprising the step of impregnating the foam material with a solution of a water soluble synthetic or natural polymer prior to compression.

14. The method according to any of claims 12-13, further comprising the step of providing the anal insert with a sleeve prior to drying.

15. The method according to claim 14, wherein the sleeve is provided with multiple holes or slits/apertures.