WO2012006670A1

WO2012006670A1 - Intra-vaginal incontinence device and an applicator for same

Info

Publication number: WO2012006670A1
Application number: PCT/AU2011/000882
Authority: WO
Inventors: Angus Taylor; Roxanne Davis; Lee Borg
Original assignee: Contiform International Pty Ltd
Priority date: 2010-07-13
Filing date: 2011-07-13
Publication date: 2012-01-19
Also published as: WO2012006670A8

Abstract

The present invention provides an intra-vaginal incontinence control device formed of elastically deformable or resilient material, the device having a displacement member (1.006) including a compression recess (1.008) whereby the displacement member can be partly deformed by pressing a portion of the displacement member into the recess, the recess wall including an invertible wall portion being part of the wall of the displacement member, the invertible wall portion including a slit (1.012). The present invention also provides an applicator for an intra-vaginal incontinence control device includes an elongate handle (7.022) and a head (7.024) including at least two prongs (7.026, 7.028) adapted for engagement with lobe recesses formed in a compressed intra-vaginal incontinence control device.

Description

intra-vaginal incontinence device and an applicator for same

Field of the invention

[001] This invention relates to an intra-vaginal incontinence control device. This invention also relates to an applicator for an intra-vaginal incontinence control device. The intra- vaginal incontinence control device will also herein be referred to as an IVD. The applicator of this invention is adapted to be used for the insertion of intra-vaginal incontinence control devices described herein or can be used with the intra-vaginal incontinence control device described in US patent 6413206, the whole of which specification is incorporated herein by reference.

Background of the invention

[002] The device of the invention is a modification of a device described in US patent

6413206. US patent 6413206 claims an intra-vaginal device to aid in controlling urinary incontinence, said device comprising: a base adapted to extend between the anterior vaginal wall and the posterior vaginal wall of a patient, so as to apply pressure thereto, said base having a forward convex surface adapted to engage the anterior vaginal wall to support and elevate the anterior vaginal wall and urethra, and a rear part adapted to engage the posterior vaginal wall; and a back portion extending from said rear part so that in use the back portion extends therefrom towards the cervix and is adapted to be supported on the pelvic floor so as to distribute the pressure applied to the posterior wall, said base being generally toroidal in configuration so as to have a central aperture.

[003] The device of the above patent includes an elastic body having a toroidal base and an apertured back, the base and the back being inclined at an slightly obtuse angle. The device is adapted to be inserted into the vagina so that the base rests on the pelvic floor. The base is adapted to exert force on the anterior vaginal wall to displace the bladder and the upper portion of the urethra upwards from the pelvic floor into the abdominal cavity. The back is adapted to distribute the pressure load against the posterior vaginal wall.

[004] In one embodiment, the device is substantially "L" shaped in side elevation. In a further embodiment, the device has a lower cylindrical section forming the base, the back being an extension of the rear side of the cylinder wall. The device is adapted to be inserted vaginally by pressing the forward end of base annulus to elastically deform it so the forward portion is deflected into the annular aperture. [005] Any reference herein to known prior art does not, unless the contrary indication appears, constitute an admission that such prior art is commonly known by those skilled in the art to which the invention relates, at the priority date of this application.

Summary of the invention

[006] The present invention provides an intra-vaginal incontinence control device formed of elastically defonnable or resilient material, the device having a displacement member having a compression recess whereby the displacement member can be partly deformed by pressing a portion of the displacement member into the recess, the recess wall including an invertible wall portion being part of the wall of the displacement member, the invertible wall portion including a slit.

[007] The slit can be oriented transverse to the deflection of the displacement member into the compression recess.

[008] The slit can be oriented to reduce deformation stress when the displacement member is pressed into the compression recess.

[009] The slit can be transverse to the compression recess.

[010] The control device can include a base and a support.

[011] The base can include the displacement member.

[012] The base can have an annular, tubular or cylindrical shape.

[013] The compression recess can be an aperture of an annulus.

[014] The base can include a forward edge adapted to be resiliently deflected into the base aperture, the inner wall of the forward edge including the slit adapted to open when the forward edge is deflected into the aperture.

[015] The device can include a location portion oriented transversely to the base.

[016] The back can be connected to the rear side of the base.

[017] The base and the back can be formed from a common cylinder with the location member.

[018] The present invention also provides an applicator for an intra-vaginal incontinence control device including an elongate handle and a head including at least two prongs adapted for engagement with lobe recesses formed in a compressed I VD.

[019] The handle can have an obround cross-section.

[020] The applicator can include two prongs with a gap therebetween adapted to receive a portion of a compressed IVD. [021] The handle can be straight.

[022] The handle can be flexible.

[023] Alternatively, the handle can be substantially rigid.

[024] The handle can be curved.

[025] The gap between the prongs can taper inwardly.

[026] The outer sides of the prongs can be inwardly curved from the free end of the prongs.

Brief description of the drawings

[027] An embodiment or embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[028] Figure 1 is an illustration showing an intra-vaginal incontinence control device according to an embodiment of the invention.

[029] Figure 2 is an illustration of the device of Figure 1 in the compressed state.

[030] Figure 3 is a side view of the device of Figure 1.

[031] Figure 4 illustrates an alternative embodiment of the invention.

[032] Figure 5 illustrates an applicator according to an embodiment showing use with a compressed IVD.

[033] Figure 6 illustrates the head of an applicator in a compressed intra-vaginal incontinence control device.

[034] Figure 7 illustrates a further embodiment of the applicator.

[035] Figure 8 illustrates an alternate applicator head.

[036] Figure 9 illustrates a further embodiment of the applicator.

[037] The numbering convention used in the drawings is that the digits in front of the full stop indicate the drawing number, and the digits after the full stop are the element reference numbers. Where possible, the same element reference number is used in different drawings to indicate corresponding elements.

[038] It is understood that, unless indicated otherwise, the drawings are intended to be illustrative rather than exact representations, and are not necessarily drawn to scale. The orientation of the drawings is chosen to illustrate the features of the objects shown, and does not necessarily represent the orientation of the objects in use. Detailed description of the embodiment or embodiments

[039] In this specification, the "base" of US patent 6413206 may be referred to as a

"displacement member", and the "rear part" of US patent 6413206 may be referred to as the "location member".

[040] Figure 1 illustrates an intra-vaginal incontinence control device 1.002 according to an embodiment of the invention:

[041 ] The device of this embodiment has two substantially transverse elements, a displacement member 1.006 and a location member 1.004.

[042] The displacement member includes a substantially annular portion defining an aperture 1.008, having a forward arcuate section 1.005. The annular portion includes a wall having a height dimension 1.007 and a thickness dimension 1.009 enclosing an aperture 1.008. As described in the above US patent specification, the height is chosen so that, in use, the forward portion of the exterior wall of the displacement member presses against the anterior wall of the vagina to provide support for the bladder above the pelvic floor.

[043] The dimensions of the aperture and annular portion of the displacement member are chosen to permit the side of the annular portion remote from the location member 1.004 to be pressed inward into the aperture 1.008. A slit 1.012 is provided in the inner portion of the wall of the forward arcuate portion 1.005 of the displacement member 1.006.

[044] The slit is preferably located symmetrically, so that the slit is will be

approximately in the centre of the portion of the displacement member pressed into the compression aperture 1.008 during insertion.

[045] The slit can extend the full height 1.007 of the wall of the annular portion of the displacement member 1.006.

[046] The slit 1.012 is preferably less than half the thickness 1.009 of the annular portion of the displacement member.

[047] The location member 1.004 in this embodiment is a substantially flat element.

Optionally, the location member can have an aperture 1.010.

[048] The location member can have any suitable shape. In this embodiment, it is substantially flat, having a thickness 1.011 over at least a portion of its surface. Optionally, the location member can include an aperture 2.010.

[049] When the device is inserted so the lower end of the displacement member is above the pelvic floor, the displacement member is able to resiliently return to the shape shown in figure 1. In this position, the displacement member presses against the anterior wall of the vagina and lifts the urethra into the stomach cavity. The location member distributes the force from the displacement member against the posterior wall of the vagina.

[050] The displacement member can have a length 3.015 of between about 35 mm to

55 mm, preferably between 40 mm to 50 mm. The height 1.007 of the displacement member can be of the order of 10 mm to 30 mm, preferably between 15 mm to 25 mm. The thickness 1.009 of the displacement member can be within the range of approximately 3 mm to 6mm, preferably within about 4 mm to 5 mm.

[051] The depth of the split .012 is preferably less than half the thickness of the displacement member. Preferably, the split is between 1 mm and 2 mm in depth.

[052] Figure 2 is an illustration of the device of Figure 1 in the compressed state in preparation for insertion. The arcuate forward section 2.005 is shown compressed into the compression aperture, the slit 2.012 is shown as being widened to a "V" groove during the deflection of the forward arcuate portion 2.005.

[053] Figure 3 is a side view of the device of Figure 1 illustrating the angle of inclination

Θ between the displacement member 3.006 and the location member 3.004. The angle Θ can be a slightly obtuse angle.

[054] The device can have various shapes and configurations. For example, the device can be formed of a tubular or cylindrical shape. Figure 4 illustrates an altemative intra-vaginal incontinence control device which can be formed from a cylindrical shape 4.014.

[055] The location member 4.006 is formed by a cut-away portion of the cylinder while the displacement member 4.0067 is formed by a cylindrical portion of the cylinder. In this embodiment, the location member does not include an aperture.

[056] The location member may include one or more transverse ribs to assist in retaining the device in place.

[057] The compression aperture 4.008 is defined by the interior wall of the basic cylindrical shape and the displacement member. .

[058] While the term "location member" and "location member" are used in the description, it is understood that these elements can be formed of a single piece of material.

[059] Figure 5 illustrates an applicator 5.022 according to an embodiment of the invention. The applicator has a handle 5.022 and a head 5.024. The head carries a pair of prongs 5.026, 5.028. The prongs are separated by a gap 5.030, which, in this embodiment is substantially U shaped. However, the inner walls of the gap can be convergent so the gap is narrower at its root than at its opening. [060] As shown in Figure 6, the prongs 6.026, 6.028 are adapted to be received in the side lobes 6.040, 6.042 of the compression recess when the displacement member is compressed into the recess.

[061 ] The convergence of the walls of the gap provide sideways compression on the compressed portion of the displacement member to assist in retaining the IVD during insertion.

[062] The applicator assists in insertion of the infra-vaginal incontinence control device.

The infra-vaginal incontinence control device is inserted into the vagina with the location member oriented towards the posterior wall. When the base of the displacement member is located above the pelvic floor with the forward side facing the anterior wall of the vagina, the user can withdraw the applicator, allowing the displacement member to resiliently assume its uncompressed state and assist in lifting the urethra into the stomach cavity.

[063] The handle of Figure 5 can be substantially rigid. The expression "substantially rigid" should be understood in the context that the intra-vaginal incontinence control device should not be brittle and should have a degree if resilience. Figure 7 illustrates further modifications of the applicator. The handle 7.022 can be curved or flexible to allow the handle to be bent through an angle Θ. The angle can be in a range between 20° and 45°. Preferably the angle is about 30°.

[064] Figure 8 illustrates modifications to the head 8.024 of the applicator. The gap

8.030 between the prongs can be a V shaped gap. The outer sides of the prongs can be recessed as shown at 8.032 to assist in retaining the infra-vaginal incontinence control device during insertion.

[065] Figure 9 illustrates a further embodiment of the applicator including a third prong

9.050. Third prong 9.050 is adapted to fit in the lobe 5.046 of the compressed displacement member to assist in retaining the intra-vaginal incontinence control device during insertion. The prong 9.050 can be located above the prongs 9.026, 9.028 to accommodate the inward curve of the compressed displacement member.

[066] The applicator can be of the order of 160 mm in overall length. The handle can have a round cross-section. However, in a preferred embodiment, the handle can be of an obround section (a rectangle with rounded ends) (see 7.022) of the order of 12 mm in width and 4 mm in depth. The head can be of the order of 18 mm wide, 8 mm deep and 30 mm in length. The width of the head being parallel to the major dimension of the handle. The prongs can be of the order of 20 mm in length and 4 mm wide at their free ends. Where the handle is rigid and curved, the free end can be curved of the order of 38 mm away from the straight handle position. [067] The obround handle provides a tactile indication of the intra-vaginal incontinence control device during insertion.

[068] In an alternative embodiment, the handle can have an "L" shape.

[069] The applicator can be adapted for use with an IVD, the applicator including a handle and two or more prongs, the prongs being adapted for insertion into the lobes of the compression recess to disengageably engage the compressed portion of the displacement member while the displacement member is compressed into the compression recess.

[070] The IVD can be formed of elastically deformable or resilient material, the IVD having a displacement member having a compression recess whereby the displacement member can be partly deformed by pressing a portion of the displacement member into the recess, the recess wall including an invertible wall portion being part of the wall of the displacement member.

[071] The IVD can include a base and a support.

[072] The base can include the displacement member.

[073] The base can have an annular, tubular or cylindrical shape.

[074] The compression recess can be an aperture of an annulus.

[075] The base can include a forward edge adapted to be resiliently deflected into the base aperture.

[076] The IVD can include a location portion oriented transversely to the base.

[077] The back can be connected to the rear side of the base.

[078] The base and the back can be formed from a common cylinder with the location member.

[079] While the term "displacement member" and "location member" are used in the description, it is understood that these elements can be formed of a single piece of material.

[080] While the applicators of Figures 5 to 9 have their operation illustrated by use with the IVD of Figures 1 to 4, it will be readily understood that the applicator can be used with the IVD of US patent 6413206.

[081] Where ever it is used, the word "comprising" is to be understood in its "open" sense, that is, in the sense of "including", and thus not limited to its "closed" sense, that is the sense of "consisting only of. A corresponding meaning is to be attributed to the corresponding words "comprise", "comprised^* and "comprises" where they appear. [082] It will be understood that the invention disclosed and defined herein extends to all alternative combinations of two or more of the individual features mentioned or evident from the text. All of these different combinations constitute various alternative aspects of the invention.

[083] While particular embodiments of this invention have been described, it will be evident to those skilled in the art that the present invention may be embodied in other specific forms without departing from the essential characteristics thereof. Hie present embodiments and examples are therefore to be considered in all respects as illustrative and not restrictive, and all modifications which would be obvious to those skilled in the art are therefore intended to be embraced therein.

Claims

1. An intra-vaginal Incontinence control device formed of elastically deformable or resilient material, the device having a displacement member including a compression recess whereby the displacement member can be partly deformed by pressing a portion of the displacement member into the recess, the recess wall including an invertible wall portion being part of the wall of the displacement member, the invertible wall portion including a slit.

2. A device as claimed in claim 1 , wherein the slit is oriented transversely to the deflection of the displacement member into the compression recess.

3. A device as claimed in claim 1 or claim 2, wherein the slit is oriented to reduce deformation stress when the displacement member is pressed into the compression recess.

4. A device as claimed in any one of the preceding claims, wherein the slit is transverse to the compression recess.

5. A device as claimed in any one of the preceding claims, including a base and a support.

6. A device as claimed in claim 5, wherein the base includes the displacement member.

7. A device as claimed in claim 5 or claim 6, wherein the base has an annular, tubular or cylindrical shape.

8. A device as claimed in any one of the preceding claims, wherein the compression recess is an aperture of an annulus.

9. A device as claimed in any one of the preceding claims, wherein the base includes a forward edge adapted to be resiliently deflected into the base aperture, the inner wall of the forward edge including the slit adapted to open when the forward edge is deflected into the aperture.

0. A device as claimed in any one of the preceding claims, including a location portion oriented transversely to the displacement member.

11. A device as claimed in claim 10, wherein the location portion is connected to the opposite side of the base to the forward portion.

12. A device as claimed in any one of the preceding claims, wherein the displacement member and the location member are formed from a common cylinder.

13. An applicator for an intra-vaginal incontinence control device including an elongate handle and a head including at least two prongs adapted for engagement with lobe recesses formed in a compressed intra-vaginal incontinence control device.

14. An applicator as claimed in claim 13, wherein the handle has an obround cross- section.

15. An applicator as claimed in claim 13 or claim 14, including two prongs with a gap therebetween adapted to receive a portion of a compressed intra-vaginal incontinence control device.

16. An applicator as claimed in any one of claims 13 to 15, wherein the handle is straight.

17. An applicator as claimed in any one of claims 13 to 16, wherein the handle is flexible.

18. An applicator as claimed in any one of claims 13 to 16, wherein the handle is substantially rigid.

19. An applicator as claimed in any one of claims 13 to 18, wherein the handle is curved.

20. An applicator as claimed in any one of claims 13 to 19, wherein the gap tapers inwardly.

21. An applicator as claimed in any one of claims 13 to 20, wherein the outer sides of the prongs are inwardly curved from the free end of the prongs.

22. An applicator for an intra-vaginal incontinence control device substantially as herein described with reference to the accompanying drawings.

23. An intra-vaginal incontinence control device substantially as herein described with reference to the accompanying drawings