VAGINAL PESSARY

Abstract

The present invention relates to a vaginal pessary having a circumferentially closed base body which has two side wall sections, a front (anterior) wall section and a rear (posterior) wall section and wherein a central opening of the base body in a cross-sectional view transverse to the height of the base body is bounded by a closed, inner oval contour line of the wall sections. According to the invention, it is provided that the inner contour line of the wall sections is delimited by a central opening deviating from the circular shape or by an essentially trapezoidal opening with rounded edges. The special feature of these designs is that there are one or more indentations in the walls, whereby the walls adhere better to the vaginal wall and thus provide a more secure hold.

Claims

1. A vaginal pessary comprising: a circumferentially closed base body, wherein the base body has two side wall sections, a front, anterior wall section and a rear, posterior wall section, and wherein a central opening of the base body in a cross-sectional view transversely to the height of the base body is delimited by a closed, inner contour line of the wall sections; wherein the inner contour line of the wall sections has a substantially egg-shaped opening which deviates from the circular shape, or wherein the inner contour line of the wall sections delimits a substantially trapezoidal opening, the opening preferably having rounded edges with a pointed end on the anterior wall section and a blunt end on the posterior wall section and/or the contour line having a substantially elliptical shape.

2. The vaginal pessary according to claim 1, wherein the front, anterior wall section and/or the rear, posterior wall section on the side of the opening is substantially convexly curved in the cross-sectional view, and wherein the front, anterior wall section and/or the rear, posterior wall section on the side of the opening is substantially differently convexly curved in the cross-sectional view.

3. The vaginal pessary according to claim 1, wherein the inner contour line of the wall sections is mirror-symmetrical to a central longitudinal axis and/or to a central transverse axis.

4. The vaginal pessary according to claim 1, wherein the base body is formed by wall sections.

5. A vaginal pessary comprising: a circumferentially closed base body, wherein the base body has two side wall sections, a front, anterior wall section and a rear, posterior wall section and wherein a central opening of the base body in a cross-sectional view transverse to the height of the base body is delimited by a closed, inner contour line of the wall sections; wherein the base body has a height which changes continuously in the circumferential direction, a minimum height being reached at the anterior wall section and/or a maximum height being reached at the posterior wall section and/or wherein at least one side wall section is raised relative to the anterior wall section and/or the posterior wall section.

6. A vaginal pessary comprising: a circumferentially closed base body, wherein the base body has two side wall sections, a front, anterior wall section and a rear, posterior wall section, and wherein a central opening of the base body, in a cross-sectional view transverse to the height of the base body, is delimited by a closed inner contour line of the wall sections; wherein the base body, in at least one side wall section, has a pocket-like deepening opened on the outside of the base body in order to form a suction or adhesion zone for adjacent tissue in an insertion state of the vaginal pessary.

7. The vaginal pessary according to claim 6, wherein the deepening is formed on an inner side of a side wall section on the side of the central opening.

8. The vaginal pessary according to claim 6, wherein the deepening is closed or open on an inner side of the base body, on the side of the central opening.

9. The vaginal pessary according to claim 6, wherein the deepening on an inner side of the base body is delimited by a thin-walled wall section which has a higher elasticity and/or lower wall thickness than side wall sections adjacent to the deepening of the base.

10. The vaginal pessary according to claim 1, wherein at least one deepening is provided in the rear, posterior wall section, wherein the receiving volume of the deepening is between 1 and 10 milliliters.

11. The vaginal pessary according to claim 10, wherein the receiving volume of the deepening is between 2 and 4 milliliters.

12. The vaginal pessary according to claim 1, wherein the side wall sections are substantially uniformly convexly curved on the side of the opening.

13. The vaginal pessary according to claim 1, wherein the contour line has a continuously convex course along the opening; and wherein the contour line is more curved and/or convexly bent in a region of the front, anterior wall section than in a region of the rear, posterior wall section.

14. The vaginal pessary according to claim 1, wherein the contour line has a continuously convex course along the opening; and wherein the thickness of the side wall sections decreases starting from a proximal outer side of the base body in the direction of a distal outer side of the base body.

15. The vaginal pessary according to claim 6, wherein the deepening is directed radially inwards.

16. The vaginal pessary according to claim 6, wherein the deepening is delimited on an inner side of the base body by a thin-walled wall section which is turned out inwards with respect to the side wall sections of the base body adjoining the deepening.

17. The vaginal pessary according to claim 6, wherein at least one deepening is provided in each side wall section, the deepenings preferably being arranged opposite one another.

18. The vaginal pessary according to claim 1, wherein at least one deepening is provided in the rear, posterior wall section, wherein an opening surface of the deepening is between 1 and 8 cm.sup.2.

19. The vaginal pessary according to claim 18, wherein the opening surface of the deepening is between 2 and 3 cm.sup.2.

20. The vaginal pessary according to claim 1, wherein at least one deepening is provided in the rear, posterior wall section, wherein an opening surface of the deepening has a convex and/or oval inner contour deviating from the circular shape in a side view.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0073] FIG. 1 is a perspective view of a vaginal pessary of the invention according to a first embodiment.

[0074] FIG. 2 is a schematic top view of the vaginal pessary according to FIG. 1.

[0075] FIG. 3 is a cross-sectional view of the vaginal pessary from FIG. 2 along section line III-III.

[0076] FIG. 4 is a front view of the vaginal pessary of the invention according to the first embodiment.

[0077] FIG. 5 is a side view of the vaginal of the invention according to the first embodiment.

[0078] FIG. 6 is a perspective front view of the vaginal pessary of the invention according to a second embodiment.

[0079] FIG. 7 is a perspective side view of the vaginal pessary according to the invention from FIG. 6.

[0080] FIG. 8 is a perspective side view of the vaginal pessary of the invention according to a third embodiment.

[0081] FIG. 9 is a top view of the vaginal pessary from FIG. 8.

[0082] FIG. 10 is a top view of the vaginal pessary of the invention according to a fourth embodiment.

[0083] FIG. 11 is a perspective side view of the vaginal pessary from FIG. 10.

[0084] FIG. 12 is a top view of the vaginal pessary according to a fifth embodiment.

[0085] FIG. 13 is a perspective rear view of the vaginal pessary according to a sixth embodiment.

[0086] FIG. 14 is a further rear view of the vaginal pessary from FIG. 13.

[0087] FIG. 15 is a perspective view of the vaginal pessary of the invention according to a sixth embodiment.

[0088] FIG. 16 is a side view of the vaginal pessary from FIG. 15.

[0089] FIG. 17 is a table showing tensile measurements on the porcine vagina model.

DETAILED DESCRIPTION

[0090] FIGS. 1 to 5 show a vaginal pessary 1 according to a first embodiment, which is used as a vaginally insertable support structure for prolapse complaints, for example after childbirth and/or as a recovery or fixation aid.

[0091] The vaginal pessary 1 has a circumferentially closed base body 2, which is designed or dimensioned for vaginal insertion for the purpose of support in the introitus area (entrance to the vagina) and/or with a lowered uterus.

[0092] The base body 2 has two side wall sections 3, 4, a front or anterior wall section 5 and a rear, posterior wall section 6.

[0093] In an inserted state of the base body 2, the anterior wall section 5 is in an orientation or alignment directed towards the front of the body, whereas the rear or posterior wall section 6 is in an orientation or alignment directed towards the rear or back of the body.

[0094] The lateral or side wall sections 3, 4 located between the anterior wall section 5 and the posterior wall section 6 are accordingly assigned to opposite sides of the patient's body, i.e. the left or right side of the body. In the inserted state, the base body 2 rests directly or circumferentially on the outside against adjacent tissue sections, in particular in such a way that body areas or organs to be supported, such as the uterus, are held or supported in the opposite direction to the direction of gravity by means of the vaginal pessary 1 or the base body 2.

[0095] The base body 2 has a central opening 7 which, in a cross-sectional view transverse to the height of the base body 2, is bounded by a closed, inner contour line 8 of the wall sections 3, 4, 5 and 6. The cross-sectional view transverse to the height of the base body 2 is ultimately to be understood as parallel to the plan view of the base body 2 shown in FIG. 2.

[0096] The inner contour line 8 defines an essentially oval-shaped opening 7 that deviates from the circular shape, as shown in FIG. 2.

[0097] The deviation from the circular shape can ultimately be of any shape, whereby circular contour sections can be provided along the inner contour line 8. However, at least one section is then provided along the inner contour line 8 in such a way that an opening 7 deviating from the circular shape is created, in particular in relation to the top view of the base body 2 shown in FIG. 2. The opening 7, which deviates from the circular shape, can be asymmetrical and ultimately take the form of any oval in order to form an inner contour line 8 that deviates from the circular shape.

[0098] In the illustrated and preferred embodiment example, the inner contour line 8 is symmetrical to a central longitudinal axis 9 of the base body 2 and has, in particular, an essentially egg shape.

[0099] It is shown and preferred that the contour line 8 has a pointed or short end on the side of the anterior wall section 5 and a long or blunt end on the side of the posterior wall section 6. Accordingly, the opening 7 in the region of the anterior wall section 5 has a smaller width, i.e. opening width, than in the region of the posterior wall section 6.

[0100] The different width of the opening 7 is to be understood in particular in relation to a central transverse axis 10 of the opening 7 and/or the base body 2 running transversely to the central longitudinal axis 9.

[0101] With reference to the same distance to the central transverse axis 10, the opening 7 in the area of the anterior wall section 5 has a reduced opening width b1 than in the area of the posterior wall section 6 with a larger width b2.

[0102] Starting from the central transverse axis 10, the width of the opening 7 decreases towards the anterior wall section 5, whereas the width initially increases starting from the central transverse axis 10 towards the posterior wall section 6 and then decreases significantly immediately before the posterior wall section 6.

[0103] The base body 2 has an outer contour line 11 opposite the inner contour line 8, with the outer contour line 11 following the course of the inner contour line 8 at least substantially and/or in sections. In other words, the base body 2 is at least substantially ring-shaped with contour lines 8, 11 that are adapted to one another, in particular parallel to one another at least in sections.

[0104] The inner contour line 8 and/or the outer contour line 11 is or are at least substantially mirror-symmetrical to the central longitudinal axis 9 and/or the central transverse axis 10 of the base body 2. In the case of mirror symmetry in relation to the central longitudinal axis 9, a preferably egg-shaped opening 7 is provided. If the mirror symmetry is present in relation to both central axes 9, 10, the opening 7 or the contour lines 8, 11 are preferably elliptical in shape. The shape to be selected is therefore varied and can be individually adapted to the intended application.

[0105] The opposing side wall sections 3, 4 are preferably curved in a substantially uniform convex manner, in particular wherein the inner contour line 8 and the outer contour line 11 are each curved in a uniform convex manner in the region of the side wall sections 3, 4.

[0106] However, it is also possible for the inner contour line 8 and/or the outer contour line 11 to be straight in the area of the side wall sections 3, 4.

[0107] As can be seen from FIG. 3, the thickness of the wall sections, preferably the side wall sections 3, 4, decreases starting from a proximal outer side 12 of the base body 2 in the direction towards a distal outer side 13 of the base body 2. In the inserted state, the proximal outer side 12 is directed towards the center of the body, whereas the distal outer side 13 is directed away from the center of the body. The decreasing thickness of the base body 2 towards the distal outer side 13 allows further improvement or adaptation of the base body 2 in the area of use, particularly with regard to close contact between the base body 2 and the adjacent tissue. This ensures secure support of the tissue sections on the vaginal pessary 1.

[0108] As illustrated in FIG. 1, the base body 2 has a height that preferably changes continuously in the circumferential direction. With a constantly changing height, there is preferably no abrupt transition or no abrupt change in height in the circumferential direction of the base body 2.

[0109] In the illustrated and preferred embodiment example, the side wall sections 3, 4 are raised relative to the anterior wall section 5 and/or the posterior wall section 6.

[0110] As illustrated in FIGS. 4 and 5, the side wall sections 3, 4 have the same maximum height. In particular, the side wall sections 3, 4 form protruding flaps with a curved upper side in relation to the posterior wall section 5 and the anterior wall section 6. This makes it easier to insert the base body 2 into the vagina. However, the side wall sections 3, 4 can also have different heights.

[0111] The posterior wall section 5 and the anterior wall section 6 preferably have the same, in particular minimal, height compared to the side wall sections 3, 4. However, a different height between the anterior wall section 5 and the posterior wall section 6 is also possible.

[0112] According to a further special feature of the present invention, which can also be realized independently, the base body 2 has a pocket-shaped deepening 14 opened on the outside of the base body 2 in order to form a better attachment for adjacent tissue in the insertion state of the vaginal pessary 1.

[0113] In the illustrated and preferred embodiment example, the side walls 3, 4 each have a deepening 14, which is designed to project radially inwards and/or radially into the opening 7, as shown in FIG. 2.

[0114] The aspect of the pocket-shaped deepening 14 is particularly preferred in conjunction with an egg-shaped inner contour line 8. In this way, an improved adaptability can be achieved in combination with a secure connection of the vaginal pessary 1.

[0115] FIG. 3 illustrates that the deepenings 14 on the inside of the base body 2, namely on the side of the central opening 7, are closed. In this case, the deepenings 14 on the inside of the base body 2 are bounded by a further or thin-walled wall section 15, which has a reduced material thickness and/or elasticity compared to the wall sections, preferably side wall sections 3, 4 of the base body 2, adjacent to the deepenings 14. Particularly preferably, the deepenings 14 are turned out inwards at the wall sections 15.

[0116] Preferably, the thin-walled wall section 15 has a material thickness that is reduced by at least 40%, preferably at least 60%, particularly preferably at least 80%, very particularly preferably at least 90%, compared to the wall section adjacent to the deepening 14, preferably an associated side wall section 3, 4.

[0117] The thin-walled wall sections 15 make it possible to reduce the suction volume within the deepenings 14 in the run-up to the operational state in order to achieve a suction effect on this basis when the wall sections 15 align themselves radially inwards again in the operational state due to their elasticity and a negative pressure builds up within the deepenings 14 as a result.

[0118] The thin-walled wall sections 15 preferably have a thickness in the range from 0.1 mm to 4 mm, preferably from 0.5 mm to 3 mm, in particular from 0.5 mm to 2 mm, particularly preferably from 0.5 mm to 1 mm, especially in the center.

[0119] The base body 2 can be manufactured using conventional production methods, for example by injection molding, casting and/or pressing with an elastomeric plastic and/or silicone.

[0120] In the embodiment shown in FIG. 6, the base body 2 has a height that changes continuously in the circumferential direction, with a minimum height being reached at the anterior wall section 5 and a maximum height being reached at the posterior wall section 6. The constantly changing height is preferably to be understood in relation to the distal outer side 13 of the base body 2, with the proximal outer side 12 preferably having a constant height and/or providing for small height changes in the circumferential direction.

[0121] The distal outer side 13 or upper side of the base body 2 is preferably beveled.

[0122] It is understood that the features shown above with regard to the first embodiment, insofar as they do not contradict the second embodiment of the vaginal pessary 1 according to FIG. 6, also apply correspondingly to the vaginal pessary 1 according to the second embodiment.

[0123] Accordingly, with reference to FIG. 7, the vaginal pessary 1 according to the second embodiment has a central opening 7 whose inner contour line 8 of the wall sections 3, 4, 5 and 6 has an essentially oval shape that deviates from the circular shape.

[0124] The third embodiment of the vaginal pessary 1 according to the invention shown in FIGS. 8 and 9 essentially corresponds to the second embodiment, with the base body 2 having more than two deepenings 14, three in the example shown. One deepening 14 is located on each of the opposing side wall sections 3, 4. In addition, a further deepening 14 is also arranged on the posterior wall section 6.

[0125] However, it is understood that, as described in connection with the second embodiment, only two deepenings 14 can be provided on the opposing side wall sections 3, 4.

[0126] As can be seen in FIG. 9, the deepenings 14 can be of different sizes and/or have different receiving volumes. Particularly preferably, the deepenings 14 assigned to the side walls 3, 4 are of the same size, whereas the deepening 14 assigned to the posterior wall section 6 has a larger receiving volume in comparison.

[0127] In the fourth embodiment shown in FIGS. 10 and 11, it is provided that at least one deepening 14 is open radially or on the inside.

[0128] Accordingly, at least one, preferably each, deepening 14 has a breakthrough 16, as illustrated in FIG. 11.

[0129] Despite the breakthroughs 16, a sufficient suction effect is ensured when the vaginal pessary 1 is inserted. At the same time, this results in further increased elasticity, as the thin-walled wall section 15 of the deepening 14 is further weakened and/or made more elastic by the breakthrough 16. At the same time, the breakthrough 16 allows fluid to drain out of the base body 2.

[0130] In the following, FIGS. 12 to 14, embodiments are described in which the inner contour line 8 is delimited by a substantially trapezoidal opening 17.

[0131] The contour line 8 is essentially straight in the area of the opposing side wall sections 3, 4. However, it is also possible for the contour line 8 to be preferably slightly convex in the area of the opposing side wall sections 3, 4, whereby a trapezoidal opening 17 is also present.

[0132] The contour line 8 is correspondingly convexly curved in the area of the anterior wall section 5 and the posterior wall section 6. However, it is also possible to form the anterior and/or posterior wall section 5, 6 in a straight line, in particular to form an exactly trapezoidal inner contour line 8 or central opening 17.

[0133] In the sixth embodiment shown in FIG. 13, the base body 2 with the trapezoidal inner opening 17 or inner contour line 8 has at least one notch 18. In the illustrated and preferred embodiment example, this notch 18 is formed on the posterior wall section 6.

[0134] In addition, in this embodiment, as shown in FIG. 14, a further notch 18 is also provided on each of the side wall sections 3, 4.

[0135] In the seventh embodiment shown in FIGS. 15 and 16, the posterior wall section 6 and the side wall sections 3, 4 have the same maximum height. In particular, the posterior wall section 6 together with the side wall sections 3, 4 form a plateau area.

[0136] The minimum height of the base body 2 is present at the anterior wall section 5, in particular whereby, starting from the anterior wall section 5, the height of the base body 2 increases on both sides in the direction of the side wall sections 3, 4 and finally reaches the maximum height at the side wall sections 3, 4.

[0137] In the embodiment example shown, the side wall sections 3, 4 and the posterior wall section 6 each have a closed recess 14.

[0138] The following features can preferably be realized equally in relation to all embodiments:

[0139] The base body 2 has a width in the range from 50 to 80 mm, preferably from 55 to 65 mm, most preferably around 60 mm.

[0140] The base body 2 has a length in the range of 55 to 90 mm, preferably in the range of 60 to 75 mm.

[0141] The base body 2 has a maximum height in the range of 15 to 45 mm, preferably in the range of 25 to 35 mm.

[0142] The base body 2 has a minimum height in the range of 5 to 15 mm, preferably in the range of 8 to 12 mm.

[0143] The maximum width, i.e. opening width, of the opening 7 and/or 17 is in the range of 30 to 50 mm, preferably in the range of 35 to 40 mm.

[0144] The base body 2 has a front, preferably bead-like, reinforcement, in particular where the reinforcement is formed on the anterior wall section 5.

[0145] The deepening 14 or the receiving volume of the deepening 14 is semi-elliptical and/or dome-shaped. The receiving volume can also be hemispherical and/or semi-elliptical.

[0146] Individual aspects and features of the present invention, in particular of the various embodiments, may be realizable and advantageous individually and in various combinations.

Validation: Production of custom-made products for individual patients at the request of doctors under confidentiality provisions, also as part of a ZIM project and summary of the findings:

General Impression:

[0147] 1) The application of models with indentations on the side walls is particularly suitable for younger women with complaints after childbirth, as the models have a high adhesive force and also allow the fluorine to drain away. [0148] 2) The application with additional indentation on the posterior wall is more suitable for older patients after prolapse surgery for additional support, [0149] 3) The prolapse symptoms were significantly improved in both groups [0150] 4) All the models used were suitable for self-management, i.e. they could be easily changed by the patient herself. [0151] 5) During a specialist examination (Prof. Dietz), transperineal ultrasound also showed contractions of the pelvic floor muscles in high-risk patients with previous damage and a reduction in the hiatus opening.

LIST OF REFERENCE SIGNS

[0152] 1 Vaginal pessary [0153] 2 Base body [0154] 3 Side wall section [0155] 4 Side wall section [0156] 5 anterior wall section [0157] 6 posterior wall section [0158] 7 Central opening [0159] 8 Inner contour line [0160] 9 Central longitudinal axis [0161] 10 Central transverse axis [0162] 11 Outer contour line [0163] 12 proximal outer side [0164] 13 distal outer side [0165] 14 Deepening [0166] 15 thin-walled wall section [0167] 16 Breakthrough [0168] 17 trapezoidal opening [0169] 18 Notch [0170] b1 Width [0171] b2 Width

LITERATURE

[0172] 1) Harvey M A, Lemieux M C, Robert M, Schulz J A. Guideline No. 411: Vaginal Pessary Use. J Obstet Gynaecol Can. 2021; 43 (2): 255-66 el. doi: 10.1016/j.jogc.2020.11.013. [0173] 2) Tunn R, Albrich S, Beilecke K, Kociszewski J, Lindig-Knopke C, Reisenauer C, et al. Interdisciplinary S2k Guideline: Sonography in Urogynecology: Short VersionAWMF Registry Number: 015/055. obstetrics gynecology. 2014; 74(12):1093-8. doi: 10.1055/s-0034-1383044. [0174] 3) Sant HAd. Prolapsus gnital de la femme-des solutions pour le traiter. 2022. doi: https://www.has-sante.fr/upload/docs/application/pdf/2022-04/reco443_fiche_patient_principale_prolapsus_cd_2022_04_28_v0.pdf. Accessed: 21.12.2022. [0175] 4) National Institute for Health and Care Excellence. NICE GuidanceUrinary incontinence and pelvic organ prolapse in women: management: (c) NICE (2019) Urinary incontinence and pelvic organ prolapse in women: management. BJU Int. 2019; 123(5):777-803. doi: 10.1111/bju.14763. [0176] 5) Lone F, Thakar R, Sultan A H. One-year prospective comparison of vaginal pessaries and surgery for pelvic organ prolapse using the validated ICIQ-VS and ICIQ-UI (SF) questionnaires. Int Urogynecol J. 2015; 26(9):1305-12. doi: 10.1007/s00192-015-2686-9. [0177] 6) Dietz H P, Walsh C, Subramaniam N, Friedman T. Levator avulsion and vaginal parity: do subsequent vaginal births matter? Int Urogynecol J. 2020; 31(11):2311-5. doi: 10.1007/s00192-020-04330-4. [0178] 7) Hilde G, Str-Jensen J, -Siafarikas F, Ellstrm M, B K: Postpartum pelvic floor muscle training, levator ani avulsion and levator hiatus area: a randomized trial. Int Urogynecol J 2023; 34:413-23. doi: 10.1007/s00192-022-05406-z