New vaginal pessary for pelvic organ prolapse and stress incontinence

Abstract

In some example embodiments, there is provided a pessary apparatus configured to alleviate pelvic organ prolapse and urinary incontinence. This pessary may a urethral support knob having a first opening and a second opening; a cylindrical stem having a proximate end, a distal end, an exterior surface, and an interior surface that forms a hollow interior of the cylindrical stem, wherein the proximate end is coupled to the second opening of the urethral support knob; and a pessary. Related apparatus, systems, methods, and / or articles of manufacture are also disclosed.

Description

NEW VAGINAL PESSARY FOR PELVIC ORGAN PROLAPSE AND STRESS INCONTINENCECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 683,469, filed August 15, 2024, entitled “NEW VAGINAL PESSARY FOR PELVIC ORGAN PROLAPSE AND STRESS INCONTINENCE”. The disclosure of which is incorporated herein by reference in their entirety.TECHNICAL FIELD

[0002] The present disclosure generally relates to a medical device and, in particular, a vaginal pessary.BACKGROUND

[0003] Pelvic organ prolapse refers to a condition where one or more pelvic organs descend from their normal positions in the vagina. This condition may be treated surgically or non-surgically. In the case of a non-surgical approach, a pessary may be inserted into the patient’s vagina to address the pelvic organ prolapse by providing support to the prolapsing organs. However, the pessary can be difficult for some to insert and / or remove, in which case a patient may go to a clinician to remove, clean, and / or replace the pessary. When this is the case, the patient’s quality of life may suffer as the patient may not be able to remove the pessary at home for cleaning, sexual activity, and / or for other reasons.SUMMARY

[0004] In some example embodiments, there is provided a pessary apparatus configured to alleviate pelvic organ prolapse and urinary incontinence. This pessary may a urethral support knob having a first opening and a second opening; a cylindrical stem having a proximate end, a distal end, an exterior surface, and an interior surface that forms a hollow interior of the cylindrical stem, wherein the proximate end is coupled to the second opening of the urethral support knob; and a pessary.

[0005] One or more of the following variations may be included. For example, the pessary may be inflatable and deflatable to enable insertion and / or removal from a vagina. The hollow interior of the cylindrical stem may be configured to enable a rod of a pessary applicator to be inserted through the hollow interior including the proximate end and the distal end of the cylindrical stem. The pessary may include a plurality of arms radiating from a first portion of the pessary and converging on a second portion of the pessary. One or more of the arms may have a variable thickness. The first portion may be formed at the distal end of the exterior surface of the cylindrical stem and the second portion is opposite, along a longitudinal axis, to the first portion. The pessary may be configured to provide an elongated state having a first diameter to enable insertion into or extraction from a vagina. The pessary may be configured to provide an expanded state having a second diameter to enable support of at least one vaginal organ. The first diameter may be smaller than the second diameter. The apparatus may further include a string coupled to pessary apparatus to enable extraction of the pessary apparatus from a vagina. The apparatus may further include a pessary applicator configured to insert at least the pessary into or extract at least the pessary from a vagina. The pessary applicator may further include a sleeve including an opening having a first end and an opposite, second end; a rod configured to slide within an interior of the sleeve; and a collar disposed on the first end of the sleeve, whereinthe collar includes a coupling mechanism to retain at least the pessary during insertion and / or extraction from the vagina.

[0006] In some example embodiments, there is provided an apparatus for inserting and / or extracting a pessary. The apparatus may include a sleeve that includes an opening having a first end and an opposite, second end; a rod configured to slide within an interior of the sleeve; a collar disposed on the first end of the sleeve; and a coupling mechanism disposed on the collar, the coupling mechanism configured to retain at least the pessary during insertion and / or extraction from a vagina.

[0007] One or more of the following variations may be included. The coupling mechanism may include a snap fit fixture. The snap fit fixture may include a plurality claws extending from the collar, wherein the plurality of claws are configured to retain the pessary in an elongated state to enable insertion and / or extraction of the pessary from the vagina. The rod may include a mechanical stop to limit advancement of the rod within the sleeve. When in a first position, the rod may be positioned within the sleeve to configure the pessary in an expanded state. When in a second position, the rod may be positioned within the sleeve to configure the snap fit fixture to retain the pessary in an elongated state. The apparatus may further include a bulb coupled to a distal end of the rod, wherein the bulb is used to apply force to the rod to move the rod between the first position and the second position.

[0008] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations. In the drawings,

[0010] FIG. 1 depicts an example of a pessary apparatus, in accordance with some embodiments;

[0011] FIGs. 2 and 3 A, 3B, and 3C depict views of the pessary apparatus of FIG. 1, in accordance with some embodiments;

[0012] FIGs. 4A, 4B, 4C, and 4D depict a pessary applicator, in accordance with some embodiments; and

[0013] FIGs. 5A-5B depict an example of an inflatable pessary, in accordance with some embodiments.DETAILED DESCRIPTION

[0014] FIG. 1 depicts an example of a pessary apparatus 100 configured to provide a pessary to alleviate pelvic organ prolapse, in accordance with some embodiments. Alternatively, or additionally, the apparatus 100 may alleviate urinary incontinence associated with the pelvic organ prolapse. FIGs. 2 and 3 A, 3B, and 3C depict additional views of the pessary apparatus 100, in accordance with some embodiments.

[0015] Referring to FIG. 1, the pessary apparatus 100 may include a urethral support knob 102. The urethral support knob (or “knob,” for short) is configured to provide support to (e.g., apply pressure to) a patient’s urethra, which may alleviate the patient’s urinary incontinence.

[0016] The urethral support knob 102 may be shaped as a donut (e.g., a toms), with a hollow, central opening 104 comprising a first opening 106A and a second, opposite opening 106B. The central opening 104 is sized to enable an applicator’s rod to be inserted into the central opening and through the first and second openings.

[0017] The apparatus 100 further includes a stem, such as a cylindrical stem 110. The cylindrical stem includes a hollow interior to enable an applicator’s rod to be inserted through the cylindrical stem. The cylindrical stem includes a proximate end 112A and a distal end 112B. The proximate end 112A is fixedly coupled to the second opening 106B of the urethral support knob 102.

[0018] The apparatus 100 further includes a pessary 120. In some embodiments, the pessary 120 includes a plurality of arms, such as arms 122A-H. In the example of FIGs. 1-3A, 3B, and 3C, the arms 122A-H radiate outward (e.g., in a longitudinal direction defined by a longitudinal axis 150A) from a first portion 124A of the pessary and converge on a second portion 124B of the pessary. The first portion 124A is formed at the distal end 112B of an exterior surface 114 of the cylindrical stem 110. The second portion 124B is opposite (along the longitudinal axis 150A which is perpendicular to an orthogonal axis 150B) to the first portion 124A.

[0019] Referring to FIG. 3C, one or more of the arms 122A-H of the pessary 120 may have a variable thickness as the arm extends and radiates from the first portion 124A of the pessary towards an apex 124C of the arm 122C and returns to the second portion 124B of the pessary. This variable thickness may facilitate the elongation of the arms during use. In the example of FIG. 3C for example, the thickness at 366B is greater than the thickness 366A at the apex 124C of the arm 122C. Likewise, the thickness at 366C is greater than the thickness 366Aat the apex 124C. The thicker areas at 366B and 366C (when compared to the apex 366 A) allow the arm to more readily elongation during insertion and / or extraction. To illustrate further, the thickness may vary within the range of 2 millimeters to 2 centimeters (although other thicknesses can be implemented as well).

[0020] Referring again to the urethral support knob 102, the urethral support knob (or “knob,” for short) is configured to, as noted, press against (e.g., apply pressure to) the patient’s urethra, which may alleviate the patient’s incontinence by providing support. The urethral support knob 102 (which in the example of FIGs. 1-3A-C is configured as a donut or torus) may have a diameter 152A of about 2 centimeters to enable (when in operation and thus inserted into the vagina) the application of pressure to the patient’s urethra. In this way, the apparatus 100 may alleviate the patient’s incontinence. An advantage of the apparatus is that it can alleviate a patient’s pelvic organ prolapse and incontinence. The width 152B of the urethral support knob 102 may be in the range of 1-3 centimeters, although other widths may be implemented as well.

[0021] Although some of the examples refer to a knob having a 2 centimeter diameter and a width of 1 centimeter to 3 centimeters, other diameters and widths may be implemented as well to provide the noted pressure to the patient’s urethra. For example, the diameter 152A may be in a range of 1 centimeter to 3 centimeters and the width within a range of Icentimeter to 3 centimeters.

[0022] Moreover, the urethral support knob’s 102 hollow, central opening 104 may have an inner diameter 152C of 1 centimeter, although other sized openings may be used as well. For example, the inner diameter 152C of the central opening may be in a range of 0.5 cm - 3 cm.

[0023] In some embodiments, the urethral support knob 102, stem 110, and pessary 120 are an integral apparatus composed of the same material, such as silicon. For example, theurethral support knob 102, stem 110, and pessary 120 may be molded out of material. The material may comprise silicon and / or other materials (e.g., polymers, thermoplastic elastomers, thermoplastic polyurethanes, poly etheretherketones, polyethylenes, and / or the like). Although the previous example described an integral urethral support knob 102, stem 110, and pessary 120, the components may be separately manufactured and assembled to form the pessary apparatus 100 (and / or may be composed of the same or different materials as well).

[0024] Although the urethral support knob 102 is described in some examples as having a torus shape, the knob may take other shapes as well, such as a rectangular cuboid, a cube, and / or other shape. Moreover, the cuboid may be symmetrical or asymmetrical.

[0025] Referring again to the pessary 120, the pessary may be composed of silicon or some other type of elastic material as noted above. In operation, the silicon enables the pessary 120 to elongate (which reduces the diameter of the pessary when compared to its normal, nonelongated state), so that the pessary can be inserted into the patient’s vagina. In the example of FIG. 4A, an applicator 400 is used to elongate the pessary 120 for insertion into the patient. Once inserted, the applicator disconnects from the pessary, such that the pessary expands to the shape shown at FIG. 1 for example and the applicator can be removed from the patient.

[0026] In some embodiments, the pessary 120 is sufficiently elastic to enable elongation as shown at FIG. 4A so that it can be readily inserted into a patient’s vagina, but the pessary is sufficiently rigidity to provide support for pelvic organ(s), such that there is little or no prolapse. For example, the pessary 120 may be composed of a medical-grade silicone elastomer having a Shore A hardness between approximately 30 and 80, an elastic modulus with sufficient elasticity to allow temporary elongation of the support arms during insertion, while possessing sufficient stiffness to maintain vaginal wall support and suburethral support during use, and avariable elongation capacity of its unstressed length to allow temporary axial elongation during insertion and removal. Upon deployment, the material provides sufficient stiffness to support pelvic organs and suburethral tissue, while maintaining a compression set of less than 20% after repeated cycles of insertion and removal.

[0027] In some implementations, the pessary 120 may be coupled to a string, such as a lanyard, thread, lasso, and / or the like. This string may be used to help remove the pessary from the patient’s vagina. The string may be fixedly attached to the pessary and / or detachably coupled to the pessary. For example, the string may be at various locations on the pessary (see, e.g., 110, 112A, 112B, 122A-H, or other locations on the pessary apparatus 100). The string may be composed of silicone or other materials.

[0028] Although some of the examples refer to the applicator 400 being used to insert and extract the pessary from a patient’s vagina, the applicator may be used to insert the pessary while the string is used to extract the pessary.

[0029] Referring again to FIGs, 1, 2, and 3 A, 3B, and 3C, the plurality of arms 122A-H may have openings between each pair of arms. Referring to FIG. 2 for example, the arms 122A- B have an opening 123A therebetween; the arms 122B-C have an opening 123B therebetween; the arms 122C-D have an opening 123C therebetween, and so forth around the pessary. In some embodiments, the openings (e.g., 152D of FIG. 2) between adjacent support arms may have range from approximately 5 mm to 30 mm (although other sized openings may be implemented as well), to facilitate drainage of bodily fluids while accommodating anatomical variation.

[0030] In some embodiments, each arm 122A-H may have a radius 186 of about 1 cm to 8 cm, although the arms may have another radius as well. As noted, an arm may be thickernear the base adjacent to the central stem to provide structural support, and thinner towards the apex to enhance flexibility and responsiveness to dynamic intra-abdominal and pelvic pressures during patient movement. This non-uniform geometry enables controlled deformation, optimizes load distribution, and improves comfort and retention during in vivo use.

[0031] In some embodiments, the plurality of arms 122A-H provide structural support, such that the pelvic organ(s) do not prolapse, while advantageously the openings 123A-C enable vaginal discharge to drain out of the pessary.

[0032] The pessary 120 may be sized to accommodate the amount of prolapse in a patient. For example, the pessary 120 may have a diameter 156A of about 5 centimeters (cm), 7 cm, or 9 cm, although the pessary may have other diameters as well. For example, the greater degree of prolapse may require a larger diameter such as 7 cm, when compared to a lesser degree of prolapse fitted with a 5 cm pessary. Alternatively, or additionally, the pessary 120 may have a width 156B of about 1 centimeter to 5 centimeters, although other widths may be used as well.

[0033] Advantageously, the applicator mechanism (see, e.g., applicator 400) elongates the pessary 120 such that it has a smaller diameter 199, when compared to the diameter 156A of the pessary in a non-elongated, normal (or expanded) state. The applicator mechanism elongates the pessary (e.g., the applicator’s rod). A pessary having for example a 5 cm diameter 156A may be elongated, so the insertion diameter 199 (see, e.g., FIG. 4A) is reduced to about 2 cm to 3 cm, for example. This reduction in diameter may facilitate atraumatic insertion and removal by the patient with or without the assistance of a trained clinician, improve ease of self-management, and / or reduce the potential for discomfort, mucosal trauma, or tissue irritation during placement or removal. The ability to self-manage insertion and removal may improve patient autonomy,reduce the burden on healthcare providers, and improve long-term patient adherence to pessary therapy for the treatment of pelvic organ prolapse and stress urinary incontinence.

[0034] Referring again to FIG. 1, the pessary 120 (when in a normal, expanded, nonelongated state) may be shaped as an oblate sphere (e.g., a sphere flattened at the poles), although other shapes may be used as well. However, the oblate sphere shape may provide geometric advantages in optimizing load distribution within the vaginal cavity. For example, the flattened polar regions minimize axial displacement under intra- abdominal pressure while the expanded equatorial region permits circumferential contact with the vaginal walls, thereby maximizing surface area engagement and stabilizing the device against rotational migration. This geometry reduces localized stress concentrations along the vaginal mucosa, which can mitigate the risk of tissue irritation, pressure necrosis, or device erosion. In addition, the plurality of elongatable support arms are configured to dynamically respond to varying intra- abdominal and pelvic forces generated by different pelvic organs during differing levels of activity. The individual arms deform and absorb localized loads, thereby distributing transient pressure fluctuations across the full contact surface of the device and reducing peak stresses applied to any single anatomic region.

[0035] Although the pessary 120 of FIG. 1 is depicted as having openings and arms, the pessary may be implemented in other forms. For example, the pessary may be implemented as a solid oblate sphere, which can be deflated for insertion or removal from the vagina but then inflated when inserted to provide the organ support. An example of such an embodiment is described below with respect to FIGs. 5A-5B.

[0036] Referring to FIG. 1 , the cylindrical stem 110 may have a length of about 1 to 4 centimeters, although the cylindrical stem may be larger or smaller in length as well. For example, the cylindrical stem may be shortened such that the knob is proximate to the arms.

[0037] FIG. 4A depicts an applicator 400 for a pessary, in accordance with some embodiments. Referring to the applicator 400 at FIG. 4A, the applicator 400 may be used to insert and / or extract the pessary apparatus 100 into a patient’s vagina, although other types of applicators may be implemented as well. FIG. 4A shows the pessary 120 in an elongated state as a result of using the applicator 400, while the pessary 120 is shown in it expanded (e.g., nonelongated or normal state) at FIG. 1A, for example. As noted, in the elongated state, the pessary has a smaller diameter 199, when compared to the diameter 156A of the pessary in the expanded state. As noted, the elongated state of the pessary facilitates the insertion and / or removal of the pessary. FIG. 4B depicts the applicator 400 configured to allow the pessary to be inserted into the applicator 400. FIG. 4C depicts the applicator 400 without the pessary. FIG. 4D depicts an exploded view of the applicator 400.

[0038] The applicator 400 includes an outer sleeve 410 including an opening comprising a first end 412A and an opposite, second end 412B. Disposed on the first end 412A is a collar 414. The collar includes including a snap fit fixture 416 configured to removably attach (e.g., grip, snap to, seat etc.) to the pessary apparatus 100.

[0039] The applicator 400 also includes a rod 420. The rod slides within the interior of the sleeve 410. The rod 420 may include a mechanical stop 422 to limit the rods longitudinal 450A sliding action within the sleeve’s hollow interior. The rod includes a proximal end 424A and a distal end 424B. The proximal end inserts into an opening 412B of the sleeve 410 andextends past the snap fit fixture 416 to enable the apparatus 100 including the pessary 120 to be elongated as shown at FIG. 4A.

[0040] The applicator 400 also includes a bulb 430 and a handle 435. In the example of FIGs. 4A-4C, the bulb 430 couples to the distal end 424B of the rod 420. For example, the bulb 430 may be affixed (e.g., via a thread or other mechanism) to the rod 420. The handle 435 is disposed proximate to second end 412B of the sleeve 410 (although it may be located at other locations along the sleeve as well). The bulb and handle enable a user of the applicator to advance the rod longitudinally 450A though the sleeve 410 to engage and / or disengage the pessary 120 from the snap fit fixture 416. The snap fit fixture may comprise claws as shown at FIG. 4A that extend from the collar 414, although other types of mechanical fixtures may be used as well to removably couple the pessary to the applicator.

[0041] In operation of the applicator 400, the snap fit fixture 416 extends over the knob 102 and snaps into place over the knob 102 as depicted at FIG. 4A to place the pessary 120 in an elongated state, which enables vaginal insertion or vaginal removal of the pessary. Pushing the bulb 430 towards the handle 435, detaches the pessary 120 from the snap fixture 416 and allows the pessary to return to a normal expanded state in a patient’s vagina. To illustrate further, the rod 420 is inserted into the apparatus 100 as shown at FIG. 4B as far as a mechanical stop 422. The bulb 430 (at the distal end 424B of the rod 420) is pulled away 450C from the handle 435 until the snap lit fixture 416 snaps over the knob 102 as shown at FIG. 4A and thus places the apparatus 100 including the pessary 102 in an elongated state. To disengage the apparatus 100 from the applicator 400, the bulb 430 is moved longitudinally 450B towards the handle 435 as shown in FIG. 4B.

[0042] FIG. 5A depicts an example an apparatus 500 including a pessary 520 (which is inflatable and deflatable) and a urethral support knob 502, in accordance with some embodiments. The pessary 520 and knob 502 are similar in some respects to the pessary 120 and knob 102 of FIG. 1 A, but the pessary 520 is inflatable. For example, the pessary 520 may be inflated as shown at FIG. 5 A and deflated as shown at FIG. 5B. In the deflated state of FOG. 5B, the pessary 520 has a smaller diameter, when compared to the inflated pessary of FIG. 5A. As such, the pessary may be inserted in a deflated state into a patient’s vagina, and then inflated to provide the pelvic organ support for prolapse and incontinence. In the example of FIG. 5A, the air source 550 may be switched 552 on to inflate the pessary 520. The pessary 520 and knob 502 may decouple from air tube 554 leaving the pessary 520 and knob 502 in the patient’s vagina. In some implementations, the pessary 520 may be coupled to a string, such as a lanyard, thread, lasso, and / or the like, to enable extraction from the vagina.

[0043] Referring again to FIGs. 1-3A, 3B, and 3C, although these depict 8 arms, the pessary may have other quantity of arms, such as 4, 2, or other quantities.

[0044] The subject matter described herein can be embodied in systems, apparatus, methods, and / or articles of manufacture depending on the desired configuration. The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail above, other modifications or additions are possible. In particular, further features and / or variations can be provided in addition to those set forth herein. For example, the implementations described above can be directed to various combinations and subcombinations of the disclosed features and / or combinations and subcombinations of severalfurther features disclosed above. Other implementations may be within the scope of the following claims.

[0045] Although ordinal numbers such as first, second and the like can, in some situations, relate to an order; as used in a document ordinal numbers do not necessarily imply an order. For example, ordinal numbers can be merely used to distinguish one item from another. For example, to distinguish a first event from a second event, but need not imply any chronological ordering or a fixed reference system (such that a first event in one paragraph of the description can be different from a first event in another paragraph of the description).

[0046] The foregoing description is intended to illustrate but not to limit the scope of the invention, which is defined by the scope of the appended claims. Other implementations are within the scope of the following claims.

[0047] In the descriptions above and in the claims, phrases such as “at least one of’ or “one or more of’ may occur followed by a conjunctive list of elements or features. The term “and / or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features. For example, the phrases “at least one of A and B;” “one or more of A and B;” and “A and / or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including three or more items. For example, the phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and / or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” Useof the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.

[0048] In view of the disclosure above, various examples are set forth below. It should be noted that one or more features of an example, taken in isolation or combination, should be considered within the disclosure of this application.

[0049] Example 1. A pessary apparatus configured to alleviate pelvic organ prolapse and urinary incontinence, the pessary apparatus comprising a urethral support knob having a first opening and a second opening; a cylindrical stem having a proximate end, a distal end, an exterior surface, and an interior surface that forms a hollow interior of the cylindrical stem, wherein the proximate end is coupled to the second opening of the urethral support knob; and a pessary.

[0050] Example 2. The pessary apparatus of Example 1, wherein the pessary is inflatable and deflatable to enable insertion and / or removal from a vagina.

[0051] Example 3. The pessary apparatus of any of Examples 1-2, wherein the hollow interior of the cylindrical stem is configured to enable a rod of a pessary applicator to be inserted through the hollow interior including the proximate end and the distal end of the cylindrical stem.

[0052] Example 4. The pessary apparatus of any of Examples 1-3, wherein the pessary comprises a plurality of arms radiating from a first portion of the pessary and converging on a second portion of the pessary.

[0053] Example 5. The pessary apparatus of any of Examples 1 -4, wherein one or more of the arms have a variable thickness.

[0054] Example 6. The pessary apparatus of any of Examples 1 -5, wherein the first portion is formed at the distal end of the exterior surface of the cylindrical stem and the second portion is opposite, along a longitudinal axis, to the first portion.

[0055] Example 7. The pessary apparatus of any of Examples 1-6, wherein the pessary is configured to provide an elongated state having a first diameter to enable insertion into or extraction from a vagina.

[0056] Example 8. The pessary apparatus of any of Examples 1-7, wherein the pessary is configured to provide an expanded state having a second diameter to enable support of at least one vaginal organ.

[0057] Example 9. The pessary apparatus of any of Examples 1-8, wherein the first diameter is smaller than the second diameter.

[0058] Example 10. The pessary apparatus of any of Examples 1-9 further comprising a string coupled to pessary apparatus to enable extraction of the pessary apparatus from a vagina.

[0059] Example 11. The pessary apparatus of any of Examples 1-10 further comprising a pessary applicator configured to insert at least the pessary into or extract at least the pessary from a vagina.

[0060] Example 12. The pessary apparatus of any of Examples 1-11, wherein the pessary applicator further comprises: a sleeve including an opening having a first end and an opposite, second end; a rod configured to slide within an interior of the sleeve; and a collar disposed on the first end of the sleeve, wherein the collar includes a coupling mechanism to retain at least the pessary during insertion and / or extraction from the vagina.

[0061] Example 13. An apparatus for inserting and / or extracting a pessary, the apparatus comprising: a sleeve including an opening having a first end and an opposite, second end; a rod configured to slide within an interior of the sleeve; a collar disposed on the first end of the sleeve; and a coupling mechanism disposed on the collar, the coupling mechanism configured to retain at least the pessary during insertion and / or extraction from a vagina.

[0062] Example 14. The apparatus of Example 13, wherein the coupling mechanism comprises a snap fit fixture.

[0063] Example 15. The apparatus of any of Examples 13-14, wherein the snap fit fixture comprises a plurality claws extending from the collar, wherein the plurality of claws are configured to retain the pessary in an elongated state to enable insertion and / or extraction of the pessary from the vagina.

[0064] Example 16. The apparatus of any of Examples 13-15, wherein the rod includes a mechanical stop to limit advancement of the rod within the sleeve.

[0065] Example 17. The apparatus of any of Examples 13-16, wherein when in a first position, the rod is positioned within the sleeve to configure the pessary in an expanded state.

[0066] Example 18. The apparatus of any of Examples 13-17, wherein when in a second position, the rod is positioned within the sleeve to configure the snap fit fixture to retain the pessary in an elongated state.

[0067] Example 19. The apparatus of any of Examples 13-18, further comprising a bulb coupled to a distal end of the rod, wherein the bulb is used to apply force to the rod to move the rod between the first position and the second position.

[0068] The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail above, other modifications or additions are possible. In particular, further features and / or variations can be provided in addition to those set forth herein. For example, the implementations described above can be directed to various combinations and sub-combinations of the disclosed features and / or combinations and sub-combinations of several further features disclosed above. In addition, the logic flows depicted in the accompanying figures and / or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. Other implementations can be within the scope of the following claims.

Claims

CLAIMSWhat is claimed:

1. A pessary apparatus configured to alleviate pelvic organ prolapse and urinary incontinence, the pessary apparatus comprising a urethral support knob having a first opening and a second opening; a cylindrical stem having a proximate end, a distal end, an exterior surface, and an interior surface that forms a hollow interior of the cylindrical stem, wherein the proximate end is coupled to the second opening of the urethral support knob; and a pessary.

2. The pessary apparatus of claim 1, wherein the pessary is inflatable and deflatable to enable insertion and / or removal from a vagina.

3. The pessary apparatus of claim 1, wherein the hollow interior of the cylindrical stem is configured to enable a rod of a pessary applicator to be inserted through the hollow interior including the proximate end and the distal end of the cylindrical stem.

4. The pessary apparatus of claim 1, wherein the pessary comprises a plurality of arms radiating from a first portion of the pessary and converging on a second portion of the pessary.

5. The pessary apparatus of claim 4, wherein one or more of the arms have a variable thickness.

6. The pessary apparatus of claim 4, wherein the first portion is formed at the distal end of the exterior surface of the cylindrical stem and the second portion is opposite, along a longitudinal axis, to the first portion.

7. The pessary apparatus of claim 4, wherein the pessary is configured to provide an elongated state having a first diameter to enable insertion into or extraction from a vagina.

8. The pessary apparatus of claim 4, wherein the pessary is configured to provide an expanded state having a second diameter to enable support of at least one vaginal organ.

9. The pessary apparatus of claim 8, wherein the first diameter is smaller than the second diameter.

10. The pessary apparatus of claim 1 further comprising a string coupled to pessary apparatus to enable extraction of the pessary apparatus from a vagina.

11. The pessary apparatus of claim 1 further comprising a pessary applicator configured to insert at least the pessary into or extract at least the pessary from a vagina.

12. The pessary apparatus of claim 11, wherein the pessary applicator further comprises: a sleeve including an opening having a first end and an opposite, second end; a rod configured to slide within an interior of the sleeve; and a collar disposed on the first end of the sleeve, wherein the collar includes a coupling mechanism to retain at least the pessary during insertion and / or extraction from the vagina.

13. An apparatus for inserting and / or extracting a pessary, the apparatus comprising:a sleeve including an opening having a first end and an opposite, second end; a rod configured to slide within an interior of the sleeve; a collar disposed on the first end of the sleeve; and a coupling mechanism disposed on the collar, the coupling mechanism configured to retain at least the pessary during insertion and / or extraction from a vagina.

14. The apparatus of claim 13, wherein the coupling mechanism comprises a snap fit fixture.

15. The apparatus of claim 14, wherein the snap fit fixture comprises a plurality claws extending from the collar, wherein the plurality of claws are configured to retain the pessary in an elongated state to enable insertion and / or extraction of the pessary from the vagina.

16. The apparatus of claim 13, wherein the rod includes a mechanical stop to limit advancement of the rod within the sleeve.

17. The apparatus of claim 13, wherein when in a first position, the rod is positioned within the sleeve to configure the pessary in an expanded state.

18. The apparatus of claim 17, wherein when in a second position, the rod is positioned within the sleeve to configure the snap fit fixture to retain the pessary in an elongated state.

19. The apparatus of claim 18, further comprising a bulb coupled to a distal end of the rod, wherein the bulb is used to apply force to the rod to move the rod between the first position and the second position.

Images