WO2006086849A1 - Insertable device with a digit protection sheath - Google Patents

Abstract

There is described an insertable member (10) for digital insertion into an orifice of a human or animal subject. The insertion member may be a tampon, suppository or other type of device which is configured to be inserted into the vagina and/or rectum of a subject. The insertion member (10) comprises an elongate insertion body (11) to be received within the orifice and a sheath member (12) which is detachably connectable to at least a portion of the elongate insertion body (11). The sheath member (12) is moveable relative to the elongate insertion body (11) between a first configuration and a second configuration such that when the sheath member (12) is in the second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

Description

"Insertable device with a digit protection sheath"

Cross-Reference to Related Applications

The present application claims priority from Australian Provisional Patent

2005900761 filed on 18 February 2005, the content of which is incorporated herein by reference.

Field of the Invention

The present invention relates to insertable members for insertion into a bodily orifice and particularly to tampons, suppositories and the like.

Background to the Invention

The insertion of a variety of devices into the vagina and/or the rectum for the treatment of a variety of conditions is well established. Suppositories, in the form of an excipient carrying an active medicine inserted into the rectum of an individual are an accepted alternative form of medicine delivery, particularly for treating rectal problems and for delivering treatment to small children who have difficulty taking medicine orally. Similarly, vaginal suppositories are employed to treat a variety of gynaecological ailments, and have been used as vaginal contraceptives.

The procedure for inserting suppositories into the associated bodily orifice in a manner that ensures maximum benefit from the device, generally requires digital assistance. In this regard, there is a potential for foreign micro-organisms to be introduced into the orifice with the suppository, together with an increased likelihood of the procedure soiling the user's or inserter's fingers.

Similarly, the use of tampons designed to be worn by females during their menstrual period to absorb menstrual fluid and the like is widespread.

Generally, there are two types of tampons on the market. The first type have an applicator which is typically made from a cardboard or plastic material. The problems with such tampons are that they are difficult to handle (often requiring multiple movable parts) and require relatively bulky packaging. Further, the applicator often causes pinching of the vaginal wall.

The second type of tampon is the digitally insertable tampon. The user, therefore, inserts the tampon into the vagina with a finger(s). However, such contact between finger and vaginal wall may result in the introduction of foreign material including micro-organisms into the vagina. Further, digital insertion results in soiling of the finger.

There is therefore a need to provide a device which can be inserted into an orifice of an individual in a relatively simple and hygienic manner.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

Summary of the Invention

Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

In a first aspect, the present invention provides an insertable member for digital insertion into an orifice of a human or animal subject, said insertable member comprising an elongate insertion body and a sheath member, said sheath member detachably connectable to at least a portion of the elongate insertion body and moveable relative to the elongate insertion body between a first configuration and a second configuration wherein when in its second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

In a second aspect, the present invention provides a tampon comprising an elongate absorbent body and a sheath member wherein the sheath member is detachably connectable to at least a portion of the elongate absorbent body and moveable relative to the elongate absorbent body between a first configuration and a second configuration wherein in its second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

In a third aspect, the invention provides a digital insertion system comprising: an elongate insertion body; and a sheath member detachably connectable to the elongate insertion body and moveable relative to the elongate insertion body between a first configuration and a second configuration wherein when in its second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

In a fourth aspect, the present invention provides a digit protection member for an insertable member said insertable member adapted for insertion into an orifice of a human or animal body, said digit protection member comprising: a sheath member detachably connectable to at least a portion of the insertable member and movable relative to the insertable member between a first configuration and a second configuration wherein when in its second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

In a fifth aspect, the invention provides a method of digitally inserting an insertable member into an orifice of a human or animal subject, the insertable member comprising an elongate insertion body that extends from a proximal end to a distal end and a sheath member detachably connected to the elongate insertion body, the method comprising;

(i) placing the distal end of the elongate insertion body substantially adjacent to the orifice and positioning one or more digits adjacent to the proximal end of the elongate insertion body;

(ii) causing the sheath member to move from a first position to a second position such that it covers at least part of the one or more digits; and

(iii) applying pressure to the proximal end of the elongate insertion body to insert said insertion body into the orifice.

The sheath member may then be detached from the elongate insertion body and the one or more digits and the sheath member withdrawn from the orifice. While embodiments describing a tampon will be discussed further below, it is to be understood that the insertable member of the first, third and fourth aspects may be used for other applications. For example, the insertable member may comprise a suppository or other like member that requires insertion into an orifice of a subject. In such cases, it is desirable that one or more digit(s) of a user is/are at least partially covered during insertion of the suppository or other like device into the orifice.

As described in the first to the fifth aspect, the insertion body extends from a proximal end to a distal end. The sheath member is typically connected to the proximal end of the insertion body.

The sheath member is typically a substantially fluid impermeable member. The sheath member is also preferably made from a suitable flexible material such that in its first configuration, it may be in a folded or a rolled configuration. The sheath member may be rolled relatively tightly against the proximal end of the elongate insertion body such as to occupy a minimum space. The sheath member may be moved from this rolled configuration in a direction away from the proximal end of the elongate insertion body to its second, unrolled/extended position. Alternatively, the sheath member may substantially cover the elongate insertion body in its first position. In its second position, the sheath member may extend away from the proximal end of the elongate insertion body such as to leave the elongate insertion body exposed.

In its second position, the sheath member extends from a first end connected to the elongate insertion body to a second free end. The sheath member in its second position defines a receptacle to receive one or more digits of a user. Typically, the sheath member is dimensioned so as to receive a single digit of a user. The sheath member may rolled down over a finger of a user during use of the insertable member.

In a further embodiment, the sheath member may be made from a biodegradable or dissolvable material. Particularly, the material may dissolve or degrade upon exposure to water.

The sheath member may be connected to the elongate insertion body by a digit engagement member. The digit engagement member is preferably connected to the proximal end of the elongate insertion body. The digit engagement member may be made from the same material as the sheath member. Alternatively, the digit engagement member may be made from a different material. For example, the digit engagement member may be made from a relatively more rigid material than the sheath member.

The digit engagement member may comprise a main body having an inner digit receiving surface and an outer insertion body receiving surface. The outer insertion body receiving surface may slidingly receive the elongate insertion body such that it is held in engagement with the digit engagement member prior to, and during, insertion into the orifice. The sliding fit between the digit engagement member and the elongate insertion member is preferably such that the insertion member does not disengage from the digit engagement member unless sufficient force is applied by a user to release the elongate insertion body.

A portion of the sheath member may be received by the digit engagement member. Typically, the first end of the sheath member is received in a groove of the digit engagement member. Preferably, the digit engagement member is made from an elastic material and both the elongate insertion body and the sheath member may be held in place by the elasticity of the material of the digit engagement member.

The inner digit receiving surface may be suitably configured to receive the tip of at least one digit of a user. Preferably, the digit engagement member provides a barrier between the digit of the user and the elongate insertion body such that there is no contact between the digit and the elongate insertion body at any time prior to, or during use of the insertable member.

The sheath member may, alternatively, be connected to the elongate insertion body by a frangible region. The frangible region may be broken to release the sheath member. Typically, the frangible region is broken by pulling the sheath member with sufficient force in a direction away from the elongate insertion body.

The sheath member may further comprise tab members at or adjacent to its free end to enable a user to grip the sheath member and pull it with sufficient force to release the sheath member and/or the digit engagement member from the elongate insertion body. In the embodiment wherein the sheath member substantially covers the insertion body in its first configuration, a user may also pull said tabs to move the sheath member into its second position, that is, extending from the proximal end of the elongate insertion body.

The sheath member and the digit engagement member may be made from any suitable biocompatible material including medical grade materials.

The sheath member and the digit engagement member may be made from a translucent material or may be semi-opaque or opaque.

The insertable member may also comprise a string member. The string member may be connected to the elongate insertion body and typically extends from the proximal end of the elongate insertion body. Prior to insertion of the elongate insertion body into an orifice of the subject, a user typically moves the string member from a first stored position wherein the string is positioned adjacent the proximal end of the elongate insertion body to a second extended position. The string member typically extends a suitable distance from the proximal end of the elongate insertion body to allow retrieval of the insertion body from the orifice. The string member, therefore, has a length that is sufficient to extend from the elongate insertion body to an end that extends from the orifice. The length of the string member may be varied depending upon the depth of the orifice and/or the required depth of insertion of the elongate insertion body.

The insertable member may further comprise an outer protective member. The outer protective member typically encases the elongate insertion body, the sheath member and the digit engagement member if present. The outer protective member therefore prevents contamination of the insertable member prior to insertion into the orifice. When required for use, the protective member may be readily removed by a number of means. In one embodiment, the protective member may comprise two components connected to each other by a release member. A first component substantially surrounds the elongate insertion body and a second component substantially surrounds the sheath member and, in certain embodiments, the digit engagement member. The release member may comprise a breakable tab member that may be broken by a user prior to release. The user may then remove the components of the protective member. Preferably, once the breakable tab member is broken, a user removes the second component of the protective member to expose the sheath member and, in certain embodiments, the digit engagement member. The sheath member may then be moved to its second configuration by the user and over one or more digits of the user. The second component of the protective member may then be removed to expose the elongate insertion body. This embodiment has the advantage that the insertion body is protected against any contamination during the actuation of the sheath member from its first to its second configuration.

The elongate insertion body and the sheath member may be manufactured as one unit, with the sheath member detachably connected to the insertion body. Alternatively, the insertion body and the sheath member and, in certain embodiments the digit engagement member may be provided separately such that a user may connect the sheath member and/or digit engagement member to the elongate insertion body prior to use.

Brief Description of the Drawings

By way of example only, preferred embodiments of the invention are now described with reference to the accompanying drawings, in which:

Figure 1 is a perspective view of an embodiment of the invention in packaged form;

Figure 2 is a further perspective view of the embodiment of Figure 1;

Figure 3 is a perspective view of another embodiment of the present invention;

Figure 4 depicts various components of one embodiment of the invention;

Figures 5a and 5b are views of one embodiment of the invention with the sheath member in its first configuration;

Figure 6 depicts the embodiment of Figure 5 with the sheath member in its second configuration; Figure 7 depicts the insertable member of the present invention ready for use; and

Figures 8 to 11 depict a further embodiment of the invention.

Detailed Description of Exemplary Embodiments

An insertion assembly is generally depicted as 10 in the accompanying drawings.

As shown in exploded form in Figure 4, the insertion assembly 10 comprises an insertion body 11 and a sheath member 12. The sheath member 12 is detachably connectable to part of the insertion body 11 and moveable relative to the insertion body 11 between a first configuration depicted, for example, in Figures 5 a and 5b and a second configuration depicted in, for example, Figure 6. In its second configuration, the sheath member is shaped to receive at least part of one or more fingers of a user.

The embodiments depicted and described herein relate to a tampon system to be typically worn and used by women during their menstrual period to absorb menstrual fluid and the like. In this regard, the insertion body 11 comprises a tampon 14 that extends from a proximal end 15 to a distal end 16. However it will be appreciated that the insertion body 11 may also comprise a suppository or other like member that requires insertion into an orifice of a subject and the present invention is not limited to the exemplary embodiment depicted in the drawings.

The sheath member 12 comprises a fluid impermeable member that is suitably flexible to be rolled when in its first configuration. As depicted in Figures 5a and 5b, the sheath member 12 is rolled relatively tightly adjacent to the proximal end 15 of the tampon 14 such as to occupy a minimum space. The sheath member 12 is movable from this rolled configuration in a direction away from the proximal end 15 of the tampon 14 to its second, unrolled position depicted in Figure 6.

In its second position, the sheath member extends from a first end 17 which is connected to the proximal end 15 of tampon 14 to a second free end 18. In its second position, the sheath member 12 defines a receptacle 20 to receive one or more fingers of a user. In normal use, the sheath member is rolled down over a finger of a user. The first end 17 of the sheath member 12 is blind ended and has a tampon engaging surface 20a and a finger engaging surface (not depicted). Therefore, the finger of a user does not come into contact with the tampon 14 during insertion of the tampon 14.

The sheath member 12 is connected to the tampon by frangible region 23.

Frangible region 23 is breakable to release the sheath member 12 from the tampon 14. The frangible region 23 is broken by pulling the sheath member 12 with sufficient force in a direction away from the tampon as indicated by arrow A.

The tampon 14 also has a string 24 attached thereto. When the tampon is packaged, the string is positioned adjacent the proximal end 15 of the tampon and when required for use can be pulled away from the tampon to an extended position. When the tampon is inserted into the vagina of a user, the string has sufficient length to extend from the tampon and from the vagina such that it may be gripped by a user.

As shown in Fig. 3, the tampon 14 and the sheath member 12 are encased by a protective casing 25. The protective casing 25 comprises a first component 26 and a second component 27 that are connected to each other by a release tab 28. The first component 26 substantially surrounds the tampon 14 and the second component substantially surrounds the sheath member 12.

The release tab 28 is broken by a user prior to release. The user may then remove the individual components of the protective casing as required.

Typically, a user removes the second component of the protective casing to expose the sheath 12. The string is also exposed at this stage. A user pulls the string to extend it away from the tampon and then the sheath member 12 is rolled down over the finger of a user and the string. The second component 27 of the protective casing is then removed to expose the tampon. The tampon is, therefore, protected against any contamination by the user's fingers during the actuation of the sheath member from its first to its second configuration.

As shown in Fig. 7, when the components of the protective casing 25 are removed and the assembly is ready for use, the finger of the user is inserted into and is covered by the sheath member 12 and the tip of the finger abuts with the proximal end of the tampon. The user may then insert the tampon into the vagina. When suitably placed, the user exerts a force in direction A to cause release of the sheath member 12 from the tampon such that the sheath member 12 can be removed leaving the tampon and string in position fur use and later removal.

It will be appreciated that in the arrangement of the present invention, during insertion of the tampon, the tampon is protected from contamination including contamination by the fingers of the user. This prevents the introduction of bacteria into the vagina and reduces the risk of infection. Further, the user avoids soiling of their fmger(s) during the step of inserting the tampon.

A further embodiment of the invention is depicted in Figures 8, 9, 10 and 11.

In this embodiment, the sheath member 12 is connected to the tampon 14 by a digit engagement member 31. The digit engagement member 31 is connected to the proximal end 15 of the tampon 14 and provides an interface between the sheath member 12 and the tampon 14.

The digit engagement member 31 is shown in more detail in Fig. 11, and comprises a main body 32 having an inner digit receiving surface 33 and an outer tampon receiving surface 34. The outer tampon receiving surface 34 slidingly receives the tampon 14 such that it is held in engagement with the digit engagement member 31 prior to, and during, insertion into the orifice. The sliding fit between the digit engagement member 31 and the tampon 14 is such that the tampon does not disengage from the digit engagement member 31 unless sufficient force is applied by a user to release the tampon.

A first end 17 of the sheath member 12 is received in groove 35 provided on the outer surface of the digit engagement member 31, such that the sheath member 12 extends over the portion of the digit engagement member 31. In this arrangement, the sheath member 12 and the digit engagement member 31 are relatively securely attached together such that any removal force applied by the user against the sheath member 12 will be transferred to the digit engagement member 31 thereby facilitating removal of both the sheath member 12 and the digit engagement member 31 from the tampon in a single action. Inner digit receiving surface 33 is configured to receive the tip of at least one digit of a user to aid the user in inserting the tampon 14. As is shown in Fig.11, to accommodate the string 24 of the tampon 14, a recess is provided in the inner digit receiving surface 33 through which the string 24 passes. In this arrangement, when the sheath member 12 and digit engagement member 31 are detached from the tampon following insertion, the string 24 will provide a ready means of removing the tampon following use, and will be appropriately positioned for gripping by the user. As will be appreciated, the digit engagement member 31 provides a barrier between the digit of the user and the tampon such that there is no contact between the digit and the tampon at any time prior to, or during insertion of the tampon.

As shown in Figures 8 and 9, prior to use, the sheath member 12 is arranged in a first position whereby it substantially covers and protects the tampon 14. In order to expose the tampon 14 for insertion, the sheath member 12 is moved to its second configuration as shown in Figure 10. The sheath member 12 has tabs 36 at its second end 18 to facilitate movement from its first to its second configuration and to further facilitate removal of the sheath 12 from the tampon 14 once the tampon is fully inserted in the vagina. As discussed above, as the sheath member 12 is relatively securely attached to the digit engagement member 31, following insertion of the tampon the user provides a force against the sheath member 12 by pulling the tabs 36 such that the tampon slidingly disengages from the outer tampon receiving surface 34.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS:

1. An insertable member for digital insertion into an orifice of a human or animal subject, comprising: an elongate insertion body; and a sheath member detachably connectable to at least a portion of the elongate insertion body and moveable relative to the elongate insertion body between a first configuration and a second configuration; wherein when said sheath member is in said second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

2. An insertable member according to claim 1, wherein the elongate insertion body extends from a proximal end to a distal end.

3. An insertable member according to claim 2, wherein the sheath member is detachably connectable to the proximal end of the insertion body.

4. An insertable member according to claim 3, wherein in said first configuration the sheath member is in a folded or a rolled configuration.

5. An insertable member according to claim 4, wherein in said first configuration said sheath member is rolled relatively tightly against the proximal end of the elongate insertion body.

6. An insertable member according to claim 4 or claim 5, wherein the sheath member is moveable from the first configuration to the second configuration by unrolling the sheath member in a direction away from the proximal end of the elongate insertion body.

7. An insertable member according to claim 3, wherein in said first configuration the sheath member substantially covers the elongate insertion body.

8. An insertable member according to claim 7, wherein in said second configuration the sheath member extends away from the proximal end of the elongate insertion body thereby exposing the elongate insertion body.

9. An insertable member according to claim 6 or claim 7, wherein in said second configuration the sheath member extends from a first end connected to the elongate insertion body to a second free end.

10. An insertable member according to claim 9, wherein in said second configuration the sheath member defines a receptacle to receive one or more digits of a user.

11. An insertable member according to claim 10, wherein the sheath member is dimensioned so as to receive a single digit of a user.

12. An insertable member according to claim 11, wherein the sheath member is configured to be rolled over a finger of a user during use of the insertable member.

13. An insertable member according claim 11 wherein the sheath member is a substantially fluid impermeable member.

14. An insertable member according to claim 10 wherein the sheath member is connected to the elongate member by a digit engagement member.

15. An insertable member according to claim 14, wherein the digit engagement member is connected to the proximal end of the elongate insertion body.

16. An insertable member according to claim 15, wherein the digit engagement member comprises a main body having an inner digit receiving surface and an outer insertion body receiving surface.

17. An insertable member according to claim 16, wherein the outer insertion body receiving surface slidingly receives the elongate insertion body such that it is held in engagement with the digit engagement member prior to, and during, insertion of the member into the orifice.

18. An insertable member according to claim 17, wherein the engagement between the digit engagement member and the elongate insertion body is such that the elongate insertion body does not disengage from the digit engagement member unless sufficient force is applied by a user to release the elongate insertion body.

19. An insertable member according to claim 14, wherein a portion of the sheath member is received by the digit engagement member.

20. An insertable member according to claim 19, wherein the first end of the sheath member is received in a groove of the digit engagement member.

21. An insertable member according to claim 20, wherein the digit engagement member is made from an elastic material and both the elongate insertion body and the sheath member are held in place by the elasticity of the material of the digit engagement member.

22. An insertable member according to claim 16, wherein the inner digit receiving surface is configured to receive the tip of at least one digit of a user.

23. An insertable member according to claim 22, wherein the digit engagement member provides a barrier between the digit of the user and the elongate insertion body such that there is no contact between the digit and the elongate insertion body at any time prior to, or during use of the insertable member.

24. An insertable member according to claim 10, wherein the sheath member is connected to the elongate insertion body by a frangible region.

25. An insertable member accoring to claim 24, wherein the frangible region is broken to release the sheath member from the elongate insertion body.

26. An insertable member according to claim 25, wherein the frangible region is broken by pulling the sheath member with sufficient force in a direction away from the elongate insertion body.

27. An insertable member according to claim 26, wherein the sheath member comprises tab members at or adjacent to its free end to enable a user to grip the sheath member and pull it with sufficient force to release the sheath member from the elongate insertion body.

28. An insertable member according to any one of the preceding claims, wherein a string member is connected to the elongate insertion body and extends from the proximal end of the elongate insertion body.

29. An insertable member according to claim 28, wherein prior to insertion of the elongate insertion body into an orifice of the subject, the string member is moved from a first stored position wherein the string is positioned adjacent the proximal end of the elongate insertion body to a second extended position.

30. An insertable member according to claim 29, wherein the string member extends a suitable distance from the proximal end of the elongate insertion body to allow retrieval of the insertion body from the orifice.

31. An insertable member according to any one of the preceding claims, further comprising an outer protective member adapted to encase at least the elongate insertion body.

32. An insertable member according to claim 31, wherein the outer protective member is removed prior to use.

33. An insertable member according to any one of the preceding claims, wherein the insertable member is a tampon.

34. An insertable member according to any one of claims 1 to 32, wherein the insertable member is a suppository.

35. A tampon comprising: an elongate absorbent body; and a sheath member detachably connected to at least a portion of the elongate absorbent body and moveable relative to the elongate absorbent body between a first configuration and a second configuration wherein in its second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

36. A digital insertion system comprising: an elongate insertion body; and a sheath member detachably connectable to the elongate insertion body and moveable relative to the elongate insertion body between a first configuration and a second configuration wherein when in its second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

37. A digit protection member for an insertable member said insertable member adapted for insertion into an orifice of a human or animal body, said digit protection member comprising: a sheath member detachably connectable to at least a portion of the insertable member and movable relative to the insertable member between a first configuration and a second configuration wherein when in its second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user.

38. A method of digitally inserting an insertable member into an orifice of a human or animal subject, the insertable member comprising an elongate insertion body that extends from a proximal end to a distal end and a sheath member detachably connected to the elongate insertion body, the method comprising;

(i) placing the distal end of the elongate insertion body substantially adjacent to the orifice and positioning one or more digits adjacent to the proximal end of the elongate insertion body;

(ii) causing the sheath member to move from a first position to a second position such that it covers at ieast part of the one or more digits; and

(iii) applying pressure to the proximal end of the elongate insertion body to insert said insertion body into the orifice.