Devices and methods for personalized pelvic care

Abstract

The present disclosure relates to pessary devices and methods of facilitating the use of pessary devices. In an embodiment, a pessary device comprises a central spine and four wing elements connected to the central spine. Each of the four wing elements are configured to be folded relative to the central spine to transform the pessary device between a deployed configuration and a folded configuration. There is also described a method comprising slidably inserting a plunger into an insert to form a plunger assembly, joining a pessary device into the insert to couple the pessary device to the plunger assembly, inserting the coupled pessary device and plunger assembly through a cover sleeve to form an applicator assembly, inserting the applicator assembly and pessary device into a vaginal canal of a patient, and sliding the plunger through the insert to deploy the pessary device into the vaginal canal.

Description

DEVICES AND METHODS FOR PERSONALIZED PELVIC CAREFIELD

[0001] The present disclosure relates to therapeutic devices and more specifically to vaginal therapeutic devices as well as methods and systems for patient measurement for designing and manufacturing patient specific therapeutic devices and vaginal therapeutic devices.BACKGROUND

[0002] Pelvic organ prolapse (POP) refers to a medical condition where the bladder, rectum, and / or uterus protrudes into the vaginal area or extends beyond the vaginal opening, sometimes leading to complete eversion of the vagina.

[0003] Risk factors for this condition include childbirth, hysterectomy, the natural process of aging, and obesity. It is estimated that approximately 40-50% of women will experience some degree of pelvic organ prolapse at some point in their life, and that 3-6% of women experience symptomatic POP.

[0004] The symptoms associated with POP can be distressing and include severe discomfort, vaginal ulceration resulting from organ protrusion, difficulties with urination or defecation, frequent urination, and urinary incontinence. These symptoms can significantly impact a woman's quality of life and overall well-being.

[0005] Currently, the treatment options for symptomatic pelvic organ prolapse include surgical interventions, the use of a pessary, and in some cases, physical therapy.

[0006] Surgical procedures aim to restore the proper position of the affected organs, often with the use of structure and mesh to attach prolapsed organs to ligaments in the pelvis and recreate pelvic support. Surgical procedures commonly include a hysterectomy.

[0007] A pessary is a medical device inserted into the vagina to provide support and alleviate the symptoms of pelvic organ prolapse. Unsuccessful fitting of the pessary is the primary reason why many patients discontinue treatment, with discontinuation rates ranging from 30% to 70% for stress urinary incontinence and pelvic organ prolapse.

[0008] Numerous vaginal pessary devices are widely recognized and readily available in the market, including rigid objects like rings, dishes, donuts, Gellhorn pessaries, cube pessaries, inflatable pessaries, Shaatz pessaries, and the like. They are typically made of biocompatible materials including rubber and silicone. Pessaries are manually inserted into and removed fromthe vagina, posing challenges for patients attempting to perform these actions on their own. Often, the difficulty involved in insertion and removal necessitates the assistance of a physician or nurse. However, even healthcare professionals may encounter difficulties, resulting in significant discomfort for the patients.

[0009] Current pessaries are difficult for a patient to remove and insert. Therefore, it is often required to visit a doctor / healthcare professional to have the pessary removed and cleaned, and then reinserted. In these instances, patients often leave the pessary in place for up to three months, which can lead to vaginal discharge, odor, infection, and other complications.

[0010] Ring pessaries are often assumed to be properly fitted when positioned posterior the pubic bone, which acts as a supportive base. However, pessary retention fundamentally relies on the support provided by level III (hiatal) structures. Level III support structures include pubic ramus, pubic symphysis and puborectal muscles and fascias. Therefore, an enlarged genital hiatus, measured in 2D from the mid-urethra to the posterior fourchette as in the POP-Q system, poses a risk factor for pessary retention failure. There remains a need for improved pessary retention and efficacy, and pessary designs that incorporate the unique dimensions of the genital hiatus.

[0011] Gellhorn pessaries are often assumed to function by a suction mechanism. Pessaries that are reliable in preventing dislodgement should be positioned in a way that maximizes the effective area overlap between the pessary and the genital hiatus (i.e., maximizing the dot product between the two). There remains a need for pessaries which can accommodate for excessive vaginal capacity, which is influenced by factors such as the length of the anterior and posterior vaginal walls and the vaginal width, especially when dealing with severe prolapse.

[0012] It is often assumed that the predominant force in POP is on the anterior vaginal wall and apex. The primary mechanical role of a pessary is to mitigate a pressure imbalance by redirecting the pressure from prolapsing pelvic floor structures through the pessary to level III (hiatal) support structures, which also maintains the pessary in place.

[0013] Customized pessaries prove particularly beneficial in cases where standard sizes or shapes may not offer adequate support or comfort. They offer personalized solutions tailored to the individual's needs. Healthcare professionals specializing in pessary fitting can evaluate the patient's condition and recommend the most suitable customized pessary option.

[0014] Although research surrounding customized pessaries is increasing, there are no commercially available customized pessaries, nor does the prior art include methods of developing and designing customized pessaries.

[0015] As discussed by the inventors previously, see for example World Intellectual Property Office patent applications 2019 / 051579 and 2022 / 147611, which are herein incorporated by reference in their entirety, it may be beneficial to replace the current manual processes of sizing, fitting etc. as well as pessary design with a personal pelvic health characterization and provisioning approach that factors user specific anatomy and physiology, user lifestyle, user experiences, automated assessments etc. into provisioning custom vaginal therapeutic devices.

[0016] Despite recent advances in the personalization of modern pessaries, there remains a need in the field for customizable pessaries that are tailored to each individual patient's unique anatomy.

[0017] There remains a need for pessaries that are optimally fit to a variety of patient requirements, including, but not limited to, unique anatomical features and / or special requirements, and patients who may not be able to find a suitable fit with standard pessaries or who are unable and / or unwilling to undergo surgery. Such a need extends to pessaries which can be customizable to accommodate the varying severity, combination, and configuration of different compartments, including the genital opening.

[0018] There remains a need for personalized pessaries made from biocompatible, flexible, material, which offers the desired flexibility and elasticity, with improved effectiveness and comfort.

[0019] There is a need in the field for tailored pessary designs based on patients' specific measurements, obtained by clinical assessment or ultrasound imaging, including assessments of the genital hiatus, vaginal width, with dimensions adjusted for individual shapes in genital hiatus, anterior and posterior vaginal wall length, and vaginal width.

[0020] There is a need in the field for customizable manufacturing methods for manufacturing personalized pessaries, including single volume manufacturing, additive and non-additive manufacturing, 3D printing, and injection molding, where pessary dimensions and characteristics can be adjusted in real-time and easily manufactured to patients' specific anatomical dimensions, for example through relation of the pessary dimensions to a patient's transperineal ultrasound measurements.

[0021] Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.BRIEF SUMMARY

[0022] It is an object of the present disclosure to mitigate limitations within the prior art relating to therapeutic devices and more specifically to vaginal therapeutic devices as well as methods and systems for patient measurement for designing and manufacturing patient specific therapeutic devices and vaginal therapeutic devices.

[0023] In accordance with one aspect, there is provided a pessary device comprising: a central spine; and four wing elements positioned around and connected to the central spine, each of the four wing elements configured to be folded relative to the central spine to transform the pessary device between a deployed configuration and a folded configuration, wherein, when the pessary device is in the deployed configuration, the central spine and the four wing elements together form a three-dimensional structure having an x-shaped transverse cross-section.

[0024] In some embodiments, the pessary device further comprises four walls each connecting a respective wing element to the central spine.

[0025] In some embodiments, each wall of the four walls is concave.

[0026] In some embodiments, each wall of the four walls is configured to be folded such that a connected wing element is also folded about the central spine.

[0027] In some embodiments, the central spine is hollow, and the pessary device further comprises a bridge extending between a first internal surface of the central spine and a second internal surface of the central spine that is opposite the first internal surface.

[0028] In some embodiments, the bridge is shaped like a rectangular prism.

[0029] In some embodiments, the pessary device further comprises at least four ribs, at least one rib extending between each wing element and the central spine.

[0030] In some embodiments, the at least four ribs comprise four pairs of ribs, each pair of ribs extending between a different one of the four wing elements and the central spine.

[0031] In some embodiments, each of the four pairs of ribs comprises: a distal-facing rib angled toward a distal end of the central spine; and a proximal-facing rib angled toward a proximal end of the central spine.

[0032] In some embodiments, the four wing elements are formed from a first material and the at least four ribs are formed from a second material that is more rigid than the first material.

[0033] In some embodiments, each of the at least four ribs comprise a convex muscle element.

[0034] In some embodiments, the central spine comprises at least four divots, each divot being positioned adjacent to a rib of the at least four ribs and configured to receive the convex muscle element of the rib when the pessary device is in the collapsed configuration.

[0035] In some embodiments, each of the four wing elements comprises a divot, wherein, when the pessary device is in the collapsed configuration, each divot of each wing element is configured to receive the convex muscle element of a rib of the at least four ribs that extends between the wing element and the central spine.

[0036] In some embodiments, at least two of the four ribs have different widths.

[0037] In some embodiments, at least two of the four ribs have different thicknesses.

[0038] In some embodiments, the four wing elements have equal lengths.

[0039] In some embodiments, at least two of the four wing elements have different lengths.

[0040] In some embodiments, a first wing element and a second wing element of the four wing elements have a first length, and a third wing element and a fourth wing element of the four wing elements have a second length that is less than the first length.

[0041] In some embodiments, a thickness of each wing element of the four wing elements varies along a longitudinal axis of the wing element.

[0042] In some embodiments, in the collapsed configuration, a transverse cross-sectional area of the pessary device is between 30% and 50% smaller than the transverse cross-sectional area of the pessary device in the deployed configuration.

[0043] In some embodiments, the pessary device is configured to be inserted into a vagina of a patient to mitigate prolapse of an organ of the patient or to mitigate incontinence.

[0044] In some embodiments, the four wing elements are configured to collapse toward the central spine when a longitudinally-directed force is applied to the central spine.

[0045] In accordance with another aspect, there is provided a pessary device comprising: a central spine; a plurality of wing elements positioned on opposed sides of the central spine, each of the plurality of wing elements being configured to be folded about the central spine to transform the pessary device from a deployed configuration to a folded configuration; aconnector positioned between respective distal ends of the plurality of wing elements; and a knob coupled to a connector.

[0046] In some embodiments, the knob is removably coupled to the connector.

[0047] In some embodiments, the knob comprises a curved surface.

[0048] In some embodiments, the curved surface is saddle shaped.

[0049] In some embodiments, the curved surface curves distally along a direction perpendicular to the central spine and curves proximally along a direction parallel to the central spine.

[0050] In some embodiments, the curved surface is uniformly curved.

[0051] In some embodiments, the pessary device is configured to be inserted into a vagina of a patient, wherein, when the pessary device is inserted into the vagina, the knob is configured to provide support to a urethra of the patient.

[0052] In some embodiments, the plurality of wing elements are connected to the central spine.

[0053] In some embodiments, the connector extends from a distal end of the central spine.

[0054] In some embodiments, the connector comprises: a first notch formed in a first side of the connector; and a second notch formed in a second side of the connector opposite the first side, wherein the knob couples to the first and second notches.

[0055] In some embodiments, the first notch and the second notch are laterally aligned.

[0056] In some embodiments, the first notch is at least partially longitudinally offset from the second notch.

[0057] In some embodiments, the first notch is longitudinally offset from the second notch by between 2.5 mm and 7.5 mm.

[0058] In some embodiments, the pessary device further comprises a plurality of ribs, each rib extending between one of the plurality of wing elements and the central spine.

[0059] In some embodiments, the plurality of ribs comprises a plurality of pairs of ribs, each pair of ribs extending between a different one of the plurality of wing elements and the central spine.

[0060] In some embodiments, each of the plurality of pairs of ribs comprises: a distal-facing rib angled toward a distal end of the central spine; and a proximal-facing rib angled toward a proximal end of the central spine.

[0061] In some embodiments, the central spine extends from the knob.

[0062] In some embodiments, the plurality of wing elements are connected to the connector.

[0063] In some embodiments, the connector comprises a pair of arms defining a gap therebetween, wherein a portion of the central spine adjacent to the knob is positioned in the gap when the knob is coupled to the connector.

[0064] In some embodiments, the pessary device further comprises a rib that extends between proximal portions of the plurality of wing elements.

[0065] In some embodiments, the distal end of the central spine comprises an indent that engages with the rib when the knob is removably coupled to the connector.

[0066] In accordance with another aspect, there is provided a system, comprising: a pessary device comprising: a central spine, and a plurality of wing elements disposed around and connected to the central spine, the wing elements being movable toward and away from to transform the pessary device between a deployed configuration and a folded configuration; and an applicator, comprising: a cover sleeve, an insert defining a central hole therethrough and having a face corresponding to a form of the pessary device in the folded configuration, the insert being configured to seat the pessary device on the face and within the lumen of the sleeve, and a plunger configured to extend through the central hole and contact a seated pessary device, the plunger being configured to slide relative to the insert to deploy the pessary device from the sleeve, thereby causing the pessary device to transform from the folded configuration to the deployed configuration.

[0067] In some embodiments, the face of the insert is configured to seat a portion of the central spine and each of the plurality of wing elements.

[0068] In some embodiments, a distal end of the plunger comprises a loop configured to receive a user’s finger.

[0069] In some embodiments, the cover sleeve comprises a flexible material, a rigid material, or a combination thereof.

[0070] In some embodiments, the cover sleeve includes a distal opening and a proximal opening, and wherein an area of the proximal opening is smaller than an area of the distal opening.

[0071] In some embodiments, a transverse cross-sectional shape of the cover sleeve is a round-cornered rectangle, a round-cornered square, or a round-cornered trapezoid.

[0072] In some embodiments, the face comprises a first notch formed in an outer surface thereof; the cover sleeve comprises a second notch formed in an outer surface thereof; and the first notch and the second notch are configured to be aligned when the insert is coupled to the cover sleeve.

[0073] In some embodiments, the pessary device comprises four wing elements.

[0074] In some embodiments, the pessary device further comprises at least four ribs, at least one rib extending between each wing element and the central spine.

[0075] In some embodiments, the at least four ribs comprise four pairs of ribs, each pair of ribs extending between a different one of the four wing elements and the central spine.

[0076] In some embodiments, each of the four pairs of ribs comprises: a distal-facing rib angled toward a distal end of the central spine; and a proximal-facing rib angled toward a proximal end of the central spine.

[0077] In some embodiments, the four wing elements are formed from a first material and the at least four ribs are formed from a second material that is more rigid than the first material.

[0078] In some embodiments, each of the at least four ribs comprises a convex muscle element.

[0079] In some embodiments, the central spine comprises at least four divots, each divot being positioned adjacent to a rib of the at least four ribs and configured to receive the convex muscle element of the rib when the pessary device is in the collapsed configuration.

[0080] In some embodiments, each of the four wing elements comprises a divot, wherein, when the pessary device is in the collapsed configuration, each divot of each wing element is configured to receive the convex muscle element of a rib of the at least four ribs that extends between the wing element and the central spine.

[0081] In some embodiments, the plurality of wing elements have equal lengths.

[0082] In some embodiments, at least two of the plurality of wing elements have different lengths.

[0083] In some embodiments, a first wing element and a second wing element of the plurality of wing elements have a first length, and a third wing element and a fourth wing element of the plurality of wing elements have a second length that is less than the first length.

[0084] In some embodiments, in the collapsed configuration, a transverse cross-sectional area of the pessary device is between 30% and 50% smaller than the transverse cross-sectional area of the pessary device in the deployed configuration.

[0085] In some embodiments, the plurality of wing elements are configured to collapse toward the central spine when a longitudinally-directed force is applied to the central spine.

[0086] In accordance with another aspect, there is provided a method comprising: slidably inserting a plunger into a central through-hole of an insert to form a plunger assembly; joining a distal end portion of a pessary device into a corresponding cavity of a face of the insert to couple the pessary device to the plunger assembly; inserting the coupled pessary device and plunger assembly through a lumen of a cover sleeve to couple the plunger assembly to the cover sleeve to form an applicator assembly; inserting the applicator assembly and pessary device into a vaginal canal of a patient; and sliding the plunger through the central through- hole relative to the insert to deploy the pessary device into the vaginal canal through a proximal end of the cover sleeve.

[0087] In some embodiments, slidably inserting the plunger into the central through-hole of the insert comprises inserting a protrusion extending from an internal surface of the central through-hole into a corresponding groove formed in a proximal end portion of the plunger.

[0088] In some embodiments, the method further comprises folding a plurality of wing elements of the pessary device about a central spine of the pessary device prior to inserting the distal end portion of each of the plurality of wing elements into the corresponding cavity of the face of the insert.

[0089] In some embodiments, deploying the pessary transforms the pessary device from a folded configuration to a deployed configuration such that the plurality of wing elements of the pessary device unfold relative to the central spine.

[0090] In some embodiments, the method further comprises while the pessary device is disposed in the vaginal canal, re-folding the plurality of wing elements of the pessary device about the central spine to transform the pessary device from the deployed configuration to the folded configuration; and removing the pessary device from the vaginal canal.

[0091] In some embodiments, re-folding the plurality of wing elements comprises applying a longitudinal pulling force to the pessary device.

[0092] In some embodiments, the method further comprises aligning a first notch formed in an outer side surface of the insert with a second notch formed in an outer surface of the cover sleeve prior to inserting the coupled pessary device and plunger assembly through the cover sleeve.

[0093] In some embodiments, the method further comprises removing the applicator assembly from the vaginal canal; and de-coupling the plunger assembly from the cover.

[0094] In some embodiments, de-coupling the plunger assembly from the cover sleeve comprises simultaneously: compressing a pair of notches formed in opposing outer side surfaces of the cover sleeve; and sliding the plunger distally from the central through-hole.

[0095] Other aspects and features of the present disclosure will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0096] To easily identify the discussion of any particular element or act, the most significant digit or digits in a reference number refer to the figure number in which that element is first introduced.

[0097] FIG. 1 A illustrates a cross-section of a u-shaped pessary device, in accordance with one embodiment.

[0098] FIG. IB illustrates a side view of a u-shaped pessary device, in accordance with one embodiment.

[0099] FIG. 1C illustrates a perspective view of a u-shaped pessary device, in accordance with one embodiment.

[0100] FIG. ID illustrates a photograph of transperineal ultrasound measurements, in accordance with one embodiment.

[0101] FIG. IE illustrates a cross-section of a 3D printed u-shaped pessary device, in accordance with one embodiment.

[0102] FIG. IF illustrates a cross-section of a 3D printed u-shaped pessary device, in accordance with one embodiment.

[0103] FIG. 1G illustrates a u-shaped pessary device deployed in a user's body, in accordance with one embodiment.

[0104] FIG. 1H illustrates a u-shaped pessary device deployed in a user's body, in accordance with one embodiment.

[0105] FIG. II illustrates an image of a u-shaped pessary in a folded configuration, in accordance with one embodiment.

[0106] FIG. 2A illustrates a cross-section of an x-shaped pessary device, in accordance with one embodiment.

[0107] FIG. 2B illustrates a side view of an x-shaped pessary device, in accordance with one embodiment.

[0108] FIG. 2C illustrates an x-shaped pessary device deployed in a user's body, in accordance with one embodiment.

[0109] FIG. 2D illustrates an exemplary computer program to customize an x-shaped pessary device, in accordance with one embodiment.

[0110] FIG. 2E illustrates a perspective view of an x-shaped pessary device in deployed configuration, in accordance with one embodiment.[OHl] FIG. 2F illustrates a perspective view of an x-shaped pessary device in compressed configuration, in accordance with one embodiment.

[0112] FIG. 2G illustrates a cross-section of an H-shaped pessary, in accordance with one embodiment.

[0113] FIG. 2H illustrates a perspective view of a first scaffold-x: a 2-material, scaffold x- shaped pessary in a deployed configuration, in accordance with one embodiment.

[0114] FIG. 21 illustrates an additional perspective view of a first scaffold-x: a 2-material, scaffold x-shaped pessary in a deployed configuration, in accordance with one embodiment.

[0115] FIG. 2J illustrates a perspective view of a first scaffold-x: a 2-material, scaffold x- shaped pessary in a compressed configuration, in accordance with one embodiment.

[0116] FIG. 2K illustrates a perspective view of a second scaffold-x: a 1 -material, scaffold x- shaped pessary, in accordance with one embodiment.

[0117] FIG. 3 A illustrates a perspective view of a third scaffold-x: a 1 -material, scaffold-x shaped pessary with a 3D parallelepiped structure, in accordance with one embodiment.

[0118] FIG. 3B illustrates a perspective view of an alternate embodiment of a third scaffold-x, in accordance with one embodiment.

[0119] FIG. 3C illustrates an additional perspective view of an alternate embodiment of a third scaffold-x, in accordance with one embodiment.

[0120] FIG. 3D illustrates an additional perspective view of an alternate embodiment of a third scaffold-x, in accordance with one embodiment.

[0121] FIG. 3E illustrates a perspective view of another alternate embodiment of a third scaffold-x, in accordance with one embodiment.

[0122] FIG. 3F illustrates an additional perspective view of another alternate embodiment of a third scaffold-x, in accordance with one embodiment.

[0123] FIG. 3G illustrates a perspective view of a disassembled scaffold saddle pessary and a removable interchangeable knob, in accordance with one embodiment.

[0124] FIG. 3H illustrates a side view of a collapsed scaffold saddle pessary, in accordance with one embodiment.

[0125] FIG. 31 illustrates a perspective view of a removable interchangeable knob, in accordance with one embodiment.

[0126] FIG. 3 J illustrates a side view of a scaffold saddle pessary, in accordance with one embodiment.

[0127] FIG. 3K illustrates a front view of a scaffold saddle pessary, in accordance with one embodiment.

[0128] FIG. 3L illustrates a rear view of a removable interchangeable knob, in accordance with one embodiment.

[0129] FIG. 4A illustrates a perspective view of a stress urinary incontinence anchor pessary assembled with a removable interchangeable knob, in accordance with one embodiment.

[0130] FIG. 4B illustrates a perspective view of a stress urinary incontinence anchor pessary with a removable interchangeable knob in an assembled configuration, in accordance with one embodiment.

[0131] FIG. 4C illustrates a perspective view of a stress urinary incontinence anchor pessary with a removable interchangeable knob in a disassembled configuration, in accordance with one embodiment.

[0132] FIG. 4D illustrates a perspective view of a stress urinary incontinence anchor pessary assembled with a removable interchangeable knob, in accordance with another embodiment.

[0133] FIG. 4E illustrates a schematic of a stress urinary incontinence anchor pessary assembled with a removable interchangeable knob, deployed in a user's body, in accordance with one embodiment.

[0134] FIG. 5 A illustrates a top-down view of a cube shaped pessary, in accordance with one embodiment.

[0135] FIG. 5B illustrates a top-down view of a compressed cube shaped pessary, in accordance with one embodiment.

[0136] FIG. 6A illustrates a perspective view of a jellyfish design pessary, in its deployed configuration, in accordance with one embodiment.

[0137] FIG. 6B illustrates a perspective view of a jellyfish design pessary, in its configuration for insertion, in accordance with one embodiment.

[0138] FIG. 7 illustrates a perspective view of a c-shape pessary, in accordance with one embodiment.

[0139] FIG. 8 illustrates a perspective view of a bowtie accessory, in accordance with one embodiment.

[0140] FIG. 9A illustrates a top-down view of a retention component of a bowtie accessory, in accordance with one embodiment.

[0141] FIG. 9B illustrates a top-down view of a retention component of a bowtie accessory, in accordance with another embodiment.

[0142] FIG. 9C illustrates a top-down view of a retention component of a bowtie accessory, in accordance with another embodiment.

[0143] FIG. 9D illustrates a top-down view of a retention component of a bowtie accessory, in accordance with another embodiment.

[0144] FIG. 9E illustrates a top-down view of a retention component of a bowtie accessory, in accordance with another embodiment.

[0145] FIG. 9F illustrates a top-down view of a retention component of a bowtie accessory, in accordance with another embodiment.

[0146] FIG. 9G illustrates a top-down view of a retention component of a bowtie accessory, in accordance with another embodiment.

[0147] FIG. 9H illustrates a top-down view of a retention component of a bowtie accessory, in accordance with another embodiment.

[0148] FIG. 10A illustrates a perspective view of a foldable chair device in its deployed configuration, in accordance with one embodiment.

[0149] FIG. 10B illustrates a perspective view of a foldable chair device in its folded configuration, in accordance with one embodiment.

[0150] FIG. 11 A illustrates a side view of a scaffold x-shaped pessary, in accordance with another embodiment.

[0151] FIG. 1 IB illustrates a perspective view of a scaffold x-shaped pessary, in accordance with one embodiment.

[0152] FIG. 11C illustrates an additional perspective view of a scaffold x-shaped pessary, in accordance with one embodiment.

[0153] FIG. 1 ID illustrates a top-down view of a scaffold x-shaped pessary, in accordance with one embodiment.

[0154] FIG. 12A illustrates a perspective view of a scaffold saddle pessary with a removable interchangeable knob, in accordance with another embodiment.

[0155] FIG. 12B illustrates a perspective view of a scaffold saddle pessary with a removable interchangeable knob assembly shown in FIG. 12 A, in accordance with one embodiment.

[0156] FIG. 12C illustrates a top-down view of the scaffold saddle pessary with a removable interchangeable knob assembly shown in FIG. 12 A, in accordance with one embodiment.

[0157] FIG. 12D illustrates a side view of the scaffold saddle pessary with a removable interchangeable knob assembly shown in FIG. 12 A, in accordance with one embodiment.

[0158] FIG. 12E illustrates a top-down view of the scaffold saddle pessary shown in FIG. 12 A, in accordance with one embodiment.

[0159] FIG. 12F illustrates a bottom-up view of the scaffold saddle pessary shown in FIG.12 A, in accordance with one embodiment.

[0160] FIG. 12G illustrates a perspective view of a scaffold saddle pessary with a removable interchangeable knob, in accordance with another embodiment.

[0161] FIG. 12H illustrates a perspective view of a scaffold saddle pessary with a removable interchangeable knob, in accordance with another embodiment.

[0162] FIG. 121 illustrates a perspective view of a scaffold saddle pessary, in accordance with another embodiment.

[0163] FIG. 12J illustrates wing elements and a central spine of the scaffold saddle pessary shown in FIG. 12H, in accordance with one embodiment.

[0164] FIG. 12K illustrates a rear view of an interchangeable knob of the scaffold saddle pessary of FIG. 12H, in accordance with one embodiment.

[0165] FIG. 13 A illustrates a perspective view of a pessary applicator device with its components, in accordance with one embodiment.

[0166] FIG. 13B illustrates a top-down and a bottom-up view of an insert component of a pessary applicator device, in accordance with one embodiment.

[0167] FIG. 13C illustrates a bottom-up view of an insert component of a pessary applicator device, in accordance with one embodiment.

[0168] FIG. 13D illustrates a side view of an insert component of a pessary applicator device, in accordance with one embodiment.

[0169] FIG. 13E illustrates a perspective view of a pessary applicator device in use, in accordance with one embodiment.

[0170] FIG. 13F illustrates an additional perspective view of a pessary applicator device in use to deploy a pessary device, in accordance with one embodiment.

[0171] FIG. 13G illustrates an additional perspective view of a pessary applicator device in use to deploy a pessary device, in accordance with one embodiment.

[0172] FIG. 14A illustrates a side view of an x-shaped pessary device in a deployed configuration, in accordance with another embodiment.

[0173] FIG. 14B illustrates a side view of an x-shaped pessary device in a folded configuration, in accordance with another embodiment.

[0174] FIG. 15A illustrates a perspective view of a pessary applicator device in use to deploy an x-shaped pessary device, in accordance with another embodiment.

[0175] FIG. 15B illustrates a perspective view of a pessary applicator device that has deployed an x-shaped pessary device, in accordance with another embodiment.

[0176] FIG. 16 illustrates a method of inserting a pessary device using a pessary applicator device, in accordance with one embodiment.DETAILED DESCRIPTION

[0177] The present disclosure is directed to therapeutic devices and more specifically to vaginal therapeutic devices as well as methods and systems for patient measurement for designing and manufacturing patient specific therapeutic devices and vaginal therapeutic devices.

[0178] The ensuing description provides representative embodiment(s) only, and is not intended to limit the scope, applicability, or configuration of the disclosure. Rather, the ensuing description of the embodiment(s) will provide those skilled in the art with an enabling description for implementing an embodiment or embodiments of the disclosure. It being understood that various changes can be made in the function and arrangement of elements without departing from the spirit and scope as set forth in the appended claims. Accordingly, an embodiment is an example or implementation of the disclosure and not the sole implementation. Various appearances of “one embodiment,” “an embodiment” or “some embodiments” do not necessarily all refer to the same embodiments. Although various features of the disclosure may be described in the context of a single embodiment, the features may also be provided separately or in any suitable combination. Conversely, although the disclosure may describe separate embodiments for clarity, the described features can also be implemented in a single embodiment or any combination of embodiments.

[0179] Reference in the specification to “one embodiment,” “an embodiment,” “some embodiments” or “other embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiments is included in at least one embodiment, but not necessarily all embodiments, of the disclosure. The phraseology and terminology employed herein is not to be construed as limiting but is for descriptive purposes only. It is to be understood that where the claims or specification refer to “a” or “an” element, such reference is not to be construed as there being only one of that element. It is to be understood that where the specification states that a component feature, structure, or characteristic “may,” “might,” “can” or “could” be included, that particular component, feature, structure, or characteristic is not required to be included.

[0180] Reference to terms such as “left,” “right,” “top,” “bottom,” “front” and “back” are intended for use in respect to the orientation of the particular feature, structure, or element within the figures depicting embodiments of the disclosure. It would be evident that such directional terminology with respect to the actual use of a device has no specific meaning as the device can be employed in a multiplicity of orientations by the user or users. Reference to terms “including,”“comprising,” “consisting,” and grammatical variants thereof do not preclude the addition of one or more components, features, steps, integers, or groups thereof and that the terms are not to be construed as specifying components, features, steps, or integers. Likewise, the phrase “consisting essentially of,” and grammatical variants thereof, when used herein is not to be construed as excluding additional components, steps, features integers or groups thereof but rather that the additional features, integers, steps, components, or groups thereof do not materially alter the basic and novel characteristics of the claimed composition, device, or method. If the specification or claims refer to “an additional” element, that does not preclude there being more than one of the additional element.

[0181] “ Artificial intelligence” (Al, also machine intelligence, MI) as used herein may refer to, but is not limited to, intelligence exhibited by machines rather than humans or other animals which exhibit so-called natural intelligence (NI). Colloquially, the term Al is employed when a machine mimics “cognitive” functions which humans associate with other human minds, such as "learning" and "problem solving". Al may employ one or more tools, including, but not limited to search and optimization, logic, probabilistic methods for uncertain reasoning, classifiers and statistical learning methods, neural networks, deep feedforward neural networks, deep recurrent neural networks, and control theory. Al may be employed in the present disclosure by training a machine learning model to assign pessary characteristics (such as length, width, material, coating type, etc.) to a pessary within a CAD design interface, based on a plurality of patient measurements and their assigned pessary characteristics.

[0182] A “portable electronic device” (PED) as used herein and throughout this disclosure, refers to a wireless device used for communications and other applications that requires a battery or other independent form of energy for power. This includes devices, but is not limited to, such as a cellular telephone, smartphone, personal digital assistant (PDA), portable computer, pager, portable multimedia player, portable gaming console, laptop computer, tablet computer, a wearable device, an electronic reader, a vaginal therapy device (VTD), and a user specific therapeutic device (USTD).

[0183] A “fixed electronic device” (FED) as used herein and throughout this disclosure, refers to a wireless and / or wired device used for communications and other applications that requires connection to a fixed interface to obtain power. This includes, but is not limited to, a laptop computer, a personal computer, a computer server, a kiosk, a gaming console, a digital set-topbox, an analog set-top box, an Internet enabled appliance, an Internet enabled television, and a multimedia player.

[0184] An “application” (commonly referred to as an “app”) as used herein may refer to, but is not limited to, a “software application,” an element of a “software suite,” a computer program designed to allow an individual to perform an activity, a computer program designed to allow an electronic device to perform an activity, and a computer program designed to communicate with local and / or remote electronic devices. An application thus differs from an operating system (which runs a computer), a utility (which performs maintenance or general-purpose chores), and programming tools (with which computer programs are created). Generally, within the following description with respect to embodiments of the disclosure an application is generally presented in respect of software permanently and / or temporarily installed upon a PED and / or FED.

[0185] A “user” as used herein may refer to, but is not limited to, an individual exploiting a vaginal therapeutic device according to an embodiment or embodiments of the disclosure. As such an individual may be employing a vaginal therapeutic device with respect to one or more conditions, requirements, and / or preventions. As such an individual may include, but not be limited to, a person with a vagina, an animal with a vagina, a recipient of gender affirming surgery (also known as sex reassignment surgery, gender confirmation surgery, gender specific reconstruction surgery, and sex realignment surgery). In its broadest sense the user may further include, but not be limited to, mechanical systems, robotic systems, android systems, etc. that may be characterized by a requirement to exploit one or more embodiments of the disclosure. A user may be associated with biometric data which may be, but not limited to, monitored, acquired, stored, transmitted, processed and analyzed either locally or remotely to the user. A user may also be associated through one or more accounts and / or profiles with one or more of a service provider, third party provider, enterprise, social network, social media etc. via a dashboard, web service, website, software plug-in, software application, and graphical user interface.

[0186] The terms “woman” or “female” as used herein, and throughout this disclosure, refers to a human having a vagina or surgically formed vaginal structure and optionally a clitoris or clitoral region, uterus, bladder, a urethra, rectum, and / or an anus. The terms “woman” and “female” are used interchangeably herein.

[0187] “ User information” as used herein may refer to, but is not limited to, user behavior information and / or user profile information. It may also include a user's biometric information,an estimation of the user's biometric information, or a projection / prediction of a user's biometric information derived from current and / or historical biometric information.

[0188] A “vaginal therapeutic device” (VTD), also known as a vaginal orthosis or more commonly as a pessary, refers to a medical device and is a specific form of a user specific therapeutic device (USTD). A USTD may be used to support the uterus, vagina, bladder, or rectum for example. A USTD may be employed to treat a pelvic organ prolapse (POP), such as prolapse of the uterus for example, treat an intestinal issue, an enterocele (herniation of the bowel into the vaginal space), reduce the impact of an evolving POP, treat and / or reduce the impact of urinary incontinence (UI), treat and / or reduce the impact of stress UI, and treat and / or reduce the impact of urge UI. Alternatively, a USTD may be employed during pregnancy to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early) as an alternative to cervical cerclage since there are fewer potential complications. A USTD may also be used to address constipation, fecal incontinence, retroverted uterus, address cystocele, address rectocele, manage menstruation, induce an abortion, or provide and / or support contraception. A USTD may be placed temporarily or permanently. A pharmaceutical USTD may provide an effective means for the delivery of one or more pharmaceutical substances which are easily absorbed through the mucosa / epithelium of the vagina, or intended to have action in the locality, for example to delivery hormones or act against inflammation or infection, or on the uterus. An occlusive USTD may perform similarly to a cervical cap and may be used in combination with spermicide as a contraceptive. A stem USTD, a type of occlusive USTD, is an early form of the cervical cap shaped like a dome to cover the cervix but with a central rod or "stem" entering the dome to hold it in place. USTDs within the prior art are offered in a variety of forms including, but not limited, ring USTDs, lever USTDs, Gehrung USTDs, inflatable USTDs, doughnut USTDs, cube USTDs, Gellhorn USTDs, and incontinence USTDs. USTDs according to embodiments of the disclosure are designed in dependence upon the user for custom fitting and / or applications including, but not limited to, prolapse, urinal incontinence, and fecal incontinence.

[0189] “ Gender affirming surgery” (also known as gender reassignment surgery, gender confirmation surgery, genital reconstruction surgery, gender-affirming surgery, or gender realignment surgery) as used herein may refer to, but is not limited to, one or more surgical procedures that adjust a user’s physical appearance and function with respect to their genitalia which may require the user to use a vaginal therapeutic device according to an embodiment of the disclosure.

[0190] A “wearable device” or “wearable sensor” relates to miniature electronic devices that are worn by the user including those under, within, with or on top of clothing and are part of a broader general class of wearable technology which includes “wearable computers” which in contrast are directed to general or special purpose information technologies and media development. Such wearable devices and / or wearable sensors may include, but not be limited to, smartphones, smart watches, e-textiles, smart shirts, activity trackers, smart glasses, environmental sensors, medical sensors, biological sensors, physiological sensors, chemical sensors, ambient environment sensors, position sensors, neurological sensors, drug delivery systems, medical testing and diagnosis devices, and motion sensors. The wearable devices and / or wearable sensors may include, but not be limited to, devices that can stimulate and / or measure parameters related to the function of the vagina, urethra, uterus, bladder, cervix, rectum, anal sphincter, urethral sphincter, and abdominal cavity. It may also be used to measure intraabdominal pressure which can be correlated to the amount of force that the USTD will need to support.

[0191] “Biometric” information as used herein may refer to, but is not limited to, data relating to a user characterized by data relating to a subset of conditions including, but not limited to, their environment, medical condition, biological condition, physiological condition, chemical condition, ambient environment condition, position condition, neurological condition, drug condition, and one or more specific aspects of one or more of these said conditions. Accordingly, such biometric information may include, but not be limited, blood oxygenation, blood pressure, blood flow rate, heart rate, temperate, fluidic pH, viscosity, particulate content, solids content, altitude, vibration, motion, perspiration, EEG, ECG, energy level, etc. In addition, biometric information may include data relating to physiological characteristics related to the shape and / or condition of the body wherein examples may include, but are not limited to, fingerprint, facial geometry, baldness, DNA, hand geometry, odour, and scent. Biometric information may also include data relating to behavioral characteristics, including but not limited to, typing rhythm, gait, and voice. Biometric information may be measurable via wearable devices and / or sensors employed with a pessary device.

[0192] A “profile” as used herein, and throughout this disclosure, refers to a computer and / or microprocessor readable data file comprising data relating to a USTD according to an embodiment of the disclosure and / or biometric data of a user.

[0193] A “scaffold” or “scaffolds” as used herein, and throughout this disclosure, refers to a structure that is used to hold up, interface with, or support another material or element(s). This includes, but is not limited to, such two-dimensional (2D) structures such as substrates and films, three-dimensional (3D) structures such as geometrical objects, non-geometrical objects, combinations of geometrical and non-geometrical objects, naturally occurring structural configurations, and manmade structural configurations. A scaffold may be solid, hollow, and porous or a combination thereof. A scaffold may contain recesses, pores, openings, holes, vias, and channels or a combination thereof. A scaffold may be smooth, textured, have predetermined surface profiles and / or features. A scaffold may be intended to support one or more other materials, one or more films, a multilayer film, one type of particle, multiple types of particles etc. A scaffold may include, but not be limited to, a spine of a device and / or a framework, for example, which also supports a shell and / or a casing.

[0194] A “shell” as used herein, and throughout this disclosure, refers to a structure that is used to contain and / or surround at least partially and / or fully a number of elements within devices according to embodiments of the disclosure. A shell may include, but not limited to, a part or parts that are mounted to, attached to, and / or surround all or part of a scaffold or scaffolds that support elements within a device according to an embodiment of the disclosure.

[0195] A “casing” or “skin” as used herein, and throughout this disclosure, refers to a structure surrounding a scaffold and / or shell. This includes structures typically formed from an elastomer and / or silicone to provide a desired combination of physical tactile surface properties to the device it forms part of and other properties including, but not limited to, hermeticity, liquid ingress barrier, solid particulate ingress barrier, surface sheen, and colour. A casing may include, but not limited to, a part or parts that are mounted to a scaffold or scaffolds and / or a casing or casings forming part of a device according to an embodiment of the disclosure.

[0196] A "resin" as used herein may refer to, but is not limited to, a solid or highly viscous substance which is typically convertible into polymers. Resins may be plant-derived or synthetic in origin.

[0197] A "polymer" as used herein may refer to, but is not limited to, is a large molecule, or macromolecule, composed of many repeated subunits. Such polymers may be natural and synthetic and typically created via polymerization of multiple monomers. Polymers through their large molecular mass may provide unique physical properties, including toughness,viscoelasticity, and a tendency to form glasses and semi-crystalline structures rather than crystals.

[0198] A “polyester” as used herein, and throughout this disclosure, refers to a category of polymers that contain the ester functional group in their main chain. This includes but is not limited to polyesters which are naturally occurring chemicals as well as synthetics through stepgrowth polymerization, for example. Polyesters may be biodegradable or not. Polyesters may be a thermoplastic or thermoset or resins cured by hardeners. Polyesters may be aliphatic, semiaromatic or aromatic. Polyesters may include, but not be limited to, those exploiting polyglycolide, polylactic acid (PLA), polycaprolactone (PCL), polyhydroxyalkanoate (PHA), polyhydroxybutyrate (PHB), polyethylene adipate (PEA), polybutylene succinate (PBS), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PTT), and polyethylene naphthalate (PEN).

[0199] A “thermoplastic” or “thermosoftening plastic” as used herein and throughout this disclosure, refers to a category of polymers that become pliable or moldable above a specific temperature and solidify upon cooling. Thermoplastics may include, but not be limited, polycarbonate (PC), polyether sulfone (PES), polyether ether ketone (PEEK), polyethylene (PE), polypropylene (PP), poly vinyl chloride (PVC), polytetrafluoroethylene (PTFE), polyimide (PI), polyphenylsulfone (PPSU), polychlorotrifluoroethene (PCTFE or PTFCE), fluorinated ethylene propylene (FEP), and perfluoro alkoxy alkane (PF A).

[0200] An “aramid” as used herein, and throughout this disclosure, refers to an aromatic polyamide. Aramids are a class of materials fibers in which the chain molecules are highly oriented along the fiber axis, so the strength of the chemical bond can be exploited. Examples include but are not limited to fibers distributed under brand names such as Kevlar™, Technora™, Twaron™, Heracron™, Nomex™, Innegra S™ and Vectran™ as well as nylon and ultra-high molecular weight polyethylene.

[0201] A “silicone” as used herein, and throughout this disclosure, refers to a polymer that includes any inert, synthetic compound made up of repeating units of siloxane.

[0202] An “elastomeric” material or “elastomer” as used herein, and throughout this disclosure, refers to a material, generally a polymer, with viscoelasticity. Elastomers may include, but not be limited to, unsaturated rubbers such as polyisoprene, butyl rubber, ethylene propylene rubber, silicone rubber, fluorosilicone rubber, fluoroelastomers, perfluoroelastomers, and thermoplastic elastomers. 1

[0203] The term “flexible,” as used herein, refers to the ability of a body that is capable of being bent or flexed and refers to the ability of a body that has been subjected to an external force to return to its original size and / or shape once the external force has been removed or reduced to below a particular level. Something that is flexible can be, for example, resilient or malleable. A “flexible” material, such as a rubber for example, may be characterized by a low Young’s modulus.

[0204] The term “resilient,” as used herein, refers to the ability of a body that has been subjected to an external force to recover, or substantially recover, its original size and / or shape, following deformation. The term “malleable,” as used herein, refers to the ability of a body that has been subjected to an external force to deform and maintain, or substantially maintain, the deformed size and / or shape. Accordingly, a malleable material supports plastic deformation. A resilient material, such as polytetrafluorethylene for example, may be characterized by a moderate Young’s modulus. A rigid material, for example steel, may be characterized by a high Young’s modulus but may under appropriate conditions undergo plastic deformation.

[0205] The terms “folded” or “collapsed” as used herein, may be used interchangeably to refer to a flexible body configured to be in a smaller, more compact form due to the application of an external force or pressure.

[0206] A “CAD model” as used herein may refer to, but is not limited to, an electronic file containing information relating to a component, piece-part, element, assembly to be manufactured. A CAD model may define an object within a two-dimensional (2D) space or a three-dimensional (3D) space and may in addition to defining the internal and / or external geometry and structure of the object include information relating to the material(s), process(es), dimensions, tolerances, etc. Within embodiments of the disclosure the CAD model may be generated and transmitted as electronic content to a system providing manufacturing according to one or more embodiments of the disclosure. Within other embodiments of the disclosure the CAD model may be derived based upon one or more items of electronic content directly, e.g., a 3D model may be created from a series of 2D images or extracted from electronic content. The model may be designed by a clinician, or may be designed by a code, that, when given user measurements, assigns pessary characteristics.

[0207] A “fluid” as used herein may refer to, but is not limited to, a substance that continually deforms (flows) under an applied shear stress. Fluids may include, but are not limited to, liquids, gases, plasmas, and some plastic solids.

[0208] A “powder” as used herein may refer to, but is not limited to, a dry, bulk solid composed of a large number of very fine particles that may flow freely when shaken or tilted. Powders may be defined by both a combination of the material or materials they are formed from and the particle dimensions such as minimum, maximum, distribution etc. A powder may typically refer to those granular materials that have fine grain sizes but may also include larger grain sizes depending upon the dimensions of the part being manufactured, the characteristics of the additive manufacturing system etc.

[0209] “ Additive manufacturing” (AM) as used herein may refer to, but is not limited to, a process or processes used to create a three-dimensional object in which layers of material are formed under computer control. Commonly referred to as “3D printing” the processes of AM are currently defined in ISO / ASTM52900-15, which defines several categories of AM processes although others may also be viewed as AM processes. These categories being binder jetting, directed energy deposition, material extrusion, material jetting, powder bed fusion, sheet lamination and vat photopolymerization. “3D printers” exploiting custom “inkjet” print heads are a special application of plastic extrusion known as fused deposition modelling. AM processes may be applied to plastics, ceramics, and metals. AM processes for AM sintering or melting include selective laser sintering, direct metal laser sintering, and selective laser melting whilst those for deposition may include microcasting and sprayed materials. In some instances, sacrificial and / or support materials may be employed in conjunction with AM processes to achieve the desired geometry and / or combination of materials.

[0210] “Non-additive manufacturing” (NAM) as used herein may refer to, but is not limited to, a process or processes used to create a three-dimensional object by subtractive or transformative manufacturing. NAM processes may include, but are not limited to, hydroforming, stamping, injection molding, casting, machining, and welding.

[0211] The present disclosure aims to introduce a customizable pessary that is specifically designed to address the symptoms of pelvic organ prolapse (POP). Considering the unique nature of each patient and the varying severity, combination, and configuration of their different compartments, including the genital opening, it is crucial to have pessaries that can effectively accommodate these individual differences. In some cases, patient dimensions are determined using transperineal ultrasound measurements. The pessary having these custom dimensions may then be produced using manufacturing methods including, but not limited to,injection molding, non-additive manufacturing, additive manufacturing, single volume manufacturing, 3D printing, and the like.

[0212] Patient dimensions may include, but are not limited to, measurements relating to the patient's Introital Width (IW), genital hiatus (gH), Total Vaginal Length (TVL), and Vaginal Width (VW). Measurements may be taken using ultrasound (transperineal or not), manually (including using hand tools), with sensors. Dimensions may be determined during clinical assessment of the patient.

[0213] Other measurements may relate to one or more dynamic characteristics, including force, strain, and distension measurements of the user’s anatomy and / or measurements of the user’s physical characteristics, such as compliance / resilience of the user’s tissues, the movement(s) and strength of user’s musculature within the appropriate anatomical regions. These may involve mechanical and / or imaging testing discretely or in combination with other tests. Such tests may include, but not are not limited to:• Vaginal manometry.• Vaginal distension with imaging from any imaging modality such as, but not• limited to, ultrasound, magnetic resonance imaging (MRI), endoscope, LIDAR• and X-ray for example.• Urodynamic measurements including, but not limited to: o Tactile imaging for force and strain measurements, o Post-void residual volume via insertion of a urinary catheter or with the aid of a bladder scanner; o Uroflowmetry where “free” uroflowmetry measures the rate of bladder evacuation, “pressure” uroflowmetry combines rate of voiding measurements with simultaneous assessment of bladder and rectal pressures; o Multichannel cystometry which exploits a pair of pressure monitoring catheters to measure the pressure in the rectum and in the bladder to deduce the presence of contractions of the bladder wall, during bladder filling, or during other provocative maneuvers. The strength of the urethra can also be tested, using a cough or Valsalva maneuver, to confirm genuine stress incontinence; and o Urethral pressure profilometry which measures the strength of sphincter contraction.Elastography from ultrasound or MRI as well as other intravaginal measurements• and perineal measurements.• Electromyography (EMG) measurements of electrical activity of the pelvic floor• muscles.• Fluoroscopy, dynamic X-ray sequences, of the bladder and bladder neck during• voiding.• Hand tool measurements.• Intravaginal molding or casts.• Finger palpation.

[0214] Techniques may include those identified supra and others including, but not be limited, leak point pressure, vaginal manometry, ultrasound, elastography, strain sensor array, acoustic analysis, tactile imaging, and photoacoustic (optoacoustic) imaging. The measurements performed within Structural and Force, Strain and Distension may be statically acquired, i.e. with the user sitting / laying / standing within a clinic or another environment and / or dynamically acquired with the user performing one or more routine aspects of their life such as Valsalva effort, walking, exercising, running, lifting, bending, etc.

[0215] The pessary is crafted from a flexible, biocompatible medical grade material, ensuring optimal flexibility and elasticity. By tailoring the pessary to the individual's anatomy, it offers an improved fit and effectiveness compared to standard commercially available pessaries. This innovation provides a non-surgical treatment option for patients who are unable or unwilling to undergo surgery due to underlying health conditions.

[0216] The methods of obtaining measurements for a pessary by ultrasound, various adjustments that can be made to the properties of a pessary (including, but not limited to, dimensions, wall thickness, layer thickness, infill thickness, wall lines, and the like), are described in great detail with reference to FIGS 1 A-1H for a u-shaped pessary, but may be applied to any of the various structural embodiments disclosed herein: one of the advantages of the present disclosure is that a healthcare professional or a computer program, may determine which structural embodiment may be the best fit for a patient, based on their measurements or health history, and develop a specific fit in response to the patient's needs, in real-time, prior to sending the measurements to be embodied in a pessary device.

[0217] FIG. 1 A illustrates a cross-section of a u-shaped pessary 102, having a crescent-shaped opening 150 through its center, and wing elements 104 extending perpendicular to the central axis from the long sides of the body. At the tips of the wing elements 104, there are flexibleand soft appendage element 106 that run parallel to the surface of the body, increasing the contact angle and surface.

[0218] Between the attachment points of the wing elements 104 to the body and the appendages, there are thin sections 108 that allow for bending, and between the wing elements 104, there are concave, flexible walls 110 that create a thin barrier. Pressure against the convex wall 112 on the opposite side provides resistance against the vaginal wall.

[0219] When the patient is ready to insert the vaginal pessary 102, they will bend and shrink the wing elements 104 from the thinnest section of the wings 108. The patient may use a waterbased lubricant to assist with insertion of the 102 into the vagina. The patient inserts the pessary 102 into the vagina and pushes it forward until it reaches and passes the levator hiatus. Once the levator hiatus is passed, the wing elements 104 will open, and the appendage elements 106 will rest on the sulci of the anterior and posterior vaginal walls.

[0220] The u-shaped pessary 102 comprises a crescent-shaped opening 150 in its design in order to effectively support and counteract the effects of organ prolapse by providing stabilizing structures. It ensures a secure and stable fit within the vaginal cavity during movement, effectively addressing the impact of any prolapsing organ. Furthermore, the u- shaped pessary, also referred to as a vaginal pessary tube, allows for easy insertion, adjustment, and removal, eliminating common complications associated with traditional pessaries which stay in place for a long period of time, such as erosion, irritation, bleeding, and displacement.

[0221] Additionally, the pessary 102 features two flexible wing elements 104 that radially extend to anterior vaginal sulci formed by attachment of arcus tendinous fascia pelvis. The wing elements 104 are designed in crescent shape, spreading out to the sulcus of the vaginal tube. The wing elements 104 terminate as thickened pads, ensuring a secure fit and distributing the contact area. Elastic membranes are formed between the wing elements 104, which conform to the vaginal walls.

[0222] The u-shaped pessary 102 is specifically sized to smoothly pass through the levator hiatus, which is formed by the levator ani muscles. The significant axial extension of the pessary 102 prevents it from passing through the levator hiatus when the wing elements 104 are open, facilitating in-situ expansion. According to an aspect of the disclosure, the u-shaped pessary 102 may be adjusted to accommodate the individual requirements of each patient through adjusting the walls 110, 112, and wing elements 104.

[0223] In some variations, the u-shaped pessary 102 is one piece, and is made of one material. However, if desired, multiple materials may be utilized, and additional pieces, such as a knob or loop on a lower (distal) end of the device, may be employed for additional support or removal properties.

[0224] FIG. IB illustrates a side view of a u-shaped pessary 102.

[0225] The u-shaped pessary comprises rounded corners 114 and rounded edges 116 in order to facilitate insertion and removal.

[0226] The u-shaped pessary 102 comprises an elastic supporting tube with a removal hole 118 in convex wall 112 for easy insertion and removal through the vaginal canal.

[0227] The removal hole 118 allows for the insertion of the fingertip, which is used to pull and remove the pessary 102. The removal hole 118 also aids collapsing and in the separation from the vaginal wall by reducing negative pressure, along with the convex walls 112.

[0228] When the patient is ready to remove the pessary, they will insert their fingertip into the removal hole 118 in the pessary and pull it outward, simultaneously, folding the wing elements 104 at the thin sections 108, thus facilitating the contraction of the pessary for easier removal. Alternatively, a mechanical removal means may be attached through the removal hole 118, providing additional material for a user to pull on, enabling easier removal of the pessary 102. The mechanical removal means may include, but is not limited to, string, floss, hook, or an applicator / removal device. These mechanical removal means may be attached to the pessary 102 while in use, or may be employed for the sole purpose of inserting or removing the device, and are not, in that case, permanently attached to the removal hole 118.

[0229] The u-shaped pessary 102 may then undergo cleaning and be properly stored until it is required by the patient again.

[0230] FIG. 1C illustrates a u-shaped pessary 102 from a side view.

[0231] The thin section 108, whose thickness may vary, allows for folding the bendable, flexible pessary 102 over itself, in order to aid insertion.

[0232] The mechanism for expanding, retaining, and bending the vaginal tube pessary, or u- shaped pessary 102, is of a mechanical nature. The mechanism for expanding, retaining, and bending in the u-shaped pessary 102 is not restricted and can encompass various mechanical and / or material properties.

[0233] To ensure that the wing elements 104 are evenly spaced when the pessary 102 is in an expanded state, a concave and thin membrane layer, or wall, is incorporated between the wing elements 104. This membrane layer provides support to the vaginal walls while contributing to the stability of the wing openings. In the preferred configuration, both the pessary body and wing elements are constructed from biocompatible, impermeable, and non-toxic materials. These materials exhibit flexible and elastic properties, including, but not limited to, thermoplastic polyurethane, thermoplastic polyelastane, and silicone.

[0234] In order to determine the appropriate size of the innovative vaginal pessary 102 based on the patient's pelvic floor ultrasound images, specific measurements are taken. Methods of obtaining measurements from transperineal ultrasound images, involve drawing four transverse lines at the minimal hiatal dimensions on the axial image, are illustrated in FIG. ID.

[0235] Patient dimensions may include, but are not limited to, measurements relating to the patient’s Introital Width (IW), genital hiatus (gH), and Total Vaginal Length (TVL). Measurements may be taken using ultrasound (transperineal or not), manually, with a hand tool, with sensors. Additional methods of taking measurements of a user's vaginal anatomy may include those developed by the owners of the present application, for example, those taught in PCT / CA2018 / 000173, the contents of which are hereby incorporated by reference.

[0236] The pessary having these custom dimensions may then be produced using manufacturing methods including, but not limited to, injection molding, non-additive manufacturing, additive manufacturing, single volume manufacturing, 3D printing, and the like.

[0237] Accordingly, the dimensions acquired during measurement may be sent to a computer program, which may determine the optimal materials, geometry, dimensions, etc. of the pessary. When manufactured, the custom pessary may be defined in respect of the materials providing its physical geometry with the desired mechanical properties as well as external characteristics. Accordingly, the custom pessary may be defined by one or more aspects including, but not limited to:• Scaffold structure by dimension(s), material(s) etc.,• Shell structure by dimension(s), material(s) etc.,• Casing structure by dimension(s), property or properties, material(s),• Passive - active integration such as is pessary passive or does it embed sensor(s),• Control and / or data logging circuitry, wireless interface(s) etc.,• Lock-release structure,Coatings.

[0238] The first transverse line 120 is positioned below the urethra 128, while the second line 122 connects the most medial aspect of the muscle insertion on the inferior pubic ramus. The third line 124 passes through the midpoint of the anteroposterior diameter, and the fourth line 126 is placed just superior to the anal verge, between the two medial borders of the puborectalis muscle.

[0239] These transverse lines serve as reference points for sizing the pessary 102. The diameter of the vaginal tube is determined by measuring the distance between the second and third lines. The diameter at the first and fourth transverse lines, as well as the distance between the first and fourth lines, are used to determine the size of the wing openings.

[0240] Additionally, the transvaginal length is measured in the sagittal plane, extending from the echo of the cervix to the minimal hiatal plane. Based on these measurements, the height of the pessary 102 is determined, taking into account both the resting and reduced prolapse states.

[0241] By accurately measuring these dimensions, whether through ultrasound measurements or other methods of measuring user dimensions, the sizing of the u-shaped pessary 102 can be precisely customized to fit the individual patient's needs. As previously mentioned, the collapsible and expandable pessary possesses the necessary rigidity to maintain its shape even when subjected to pressure from the vaginal walls. However, it also demonstrates sufficient flexibility and resilience, allowing it to easily decrease in size for insertion into and removal from the vagina. Although the aforementioned method of taking patient measurements and creating a custom pessary is described with reference to the u-shaped pessary 102, this method may also apply to creating other embodiments of custom pessaries, some of which are further described herein.

[0242] FIG. IE and FIG. IF illustrate cross sections of u-shaped pessaries 102 according to various embodiments.

[0243] In additive manufacturing processes, including 3D printing, various properties of the u-shaped pessary 102 may be adapted or adjusted in order to provide and modify the functions of flexion, expansion, and rigidity:(a) Infill Design: The infill design refers to the pattern used to fill the interior of the printed vaginal pessary. Different infill patterns, such as rectilinear, triangles 134, cubic, concentric, gyroid 140, honeycomb, grid, or Hilbert curve, have varying degrees of flexibilityand rigidity. A pattern with more open space or gaps can increase flexibility, while a denser pattern can enhance rigidity.(b) Infill Ratio: The infill ratio determines the amount of interior fill material compared to the total volume of the object. A higher infill ratio (ranges generally from 20-80%) means a solid interior, resulting in more rigidity. Lower infill ratios create a more flexible structure by leaving more open space inside.(c) Adjusting the wall thickness 130, wall lines 132, layer thickness 136 and infill thickness 138 of the vaginal pessary 102 can impact its flexibility and rigidity. Thicker walls generally increase rigidity, while thinner walls provide more flexibility. Layer thickness 136 refers to the height of each printed layer. Thicker layers tend to make the object stiffer, while thinner layers can enhance flexibility. The infill thickness 138 specifically refers to the thickness of the internal fill material. By adjusting the infill thickness 138, the density of the interior structure may be adjusted, which affects both flexibility and rigidity. Thicker infill can increase rigidity, while thinner infill allows for more flexibility.

[0244] These features may readily be adjusted through a variety of manufacturing methods, including, but not limited to, additive / nonadditive manufacturing, and injection molding.

[0245] FIG. 1G illustrates a u-shaped pessary 102 deployed in a patient's vaginal canal.

[0246] The u-shaped pessary allows anatomical fascial support structures to reproduce native vaginal shapes. The wing elements 104 in the deployed state spread to the anterior sulci formed by the attachment of the arcus tendinous fascia to the pelvis.

[0247] Preferably, the u-shaped pessary 102 comprises elastic material, and hollow internal shape (the crescent-shaped opening 150), which allows the u-shaped pessary 102 to deform in response to intra-abdominal loads.

[0248] When positioned in the vaginal canal, the u-shaped pessary 102 takes on an expanded crescent shape, effectively supporting the natural X-shaped structure of the vagina while effectively supporting the prolapsed vaginal wall.

[0249] As depicted in the illustrative sagittal cross-sectional view of the female urogenital system in FIG. 1H, the deployed pessary 102, when positioned within the vagina, against the arcus tendinous fascia pelvis 144 and arcus tendinous fascia rectovaginalis 146, effectively mitigates, and counteracts the impact of any prolapsed organ, such as the urinary bladder,uterus 142, or rectum (anal canal 148 shown), by providing comprehensive support and containment within the vaginal cavity or vault.

[0250] The device 102 targets posterior wall support effectively, its curved shape allowing for dynamic response to loads.

[0251] FIG. II illustrates a u-shaped pessary 102 in a folded configuration 152. A user presses on the wing elements 104, which then fold over the thin section 108, the crescent-shaped opening 150 accommodating the inside of the wing elements 104.

[0252] The thickness of thin section 108, may vary, depending on the needs of the user.

[0253] A pessary device can also be x-shaped. As described in further detail below, an x-shaped pessary device can include a central spine and a plurality of wing elements positioned around and connected to the central spine. The wing elements can be configured to fold relative to the central spine to transform the pessary device between a deployed configuration and a folded configuration. In the deployed configuration, the central spine and the wing elements together form a three-dimensional structure having an x-shaped transverse cross-section.

[0254] FIGS. 2A-2K show exemplary x-shaped pessaries 212. The unique geometric structure of these pessary devices ensures that the devices fit securely and stably within the vaginal cavities of users.

[0255] The x-shaped pessary 212 can be personalized to fit each patient’s anatomy, according to the measurement methods illustrated and described in FIG. ID, and manufacturing methods illustrated and described in FIG. IE and FIG. IF. Asymmetry can be incorporated into the shape of the x-shaped pessary 212 to accommodate different anatomic features.

[0256] Patient dimensions may include, but are not limited to, measurements relating to the patient’s Introital Width (IW), genital hiatus (gH), and Total Vaginal Length (TVL).Measurements may be taken using ultrasound (transperineal or not), manually, with sensors, and during other clinical assessments.

[0257] In some cases, patient dimensions are determined using transperineal ultrasound measurements. The pessary having these custom dimensions may then be produced using manufacturing methods including, but not limited to, injection molding, non-additive manufacturing, additive manufacturing, single volume manufacturing, 3D printing, and the like.

[0258] The x-shaped pessary 212 and its various alternate embodiments is particularly useful in treating patients who cannot access standard pessaries, including, but not limited to, patientswith a short total vaginal length (TVL), and large genital hiatus (gH), as the length of the pessary along the vaginal axis and lateral dimensions of the x-shape portion can be personalized to the patient’s TVL and genital hiatus dimensions, respectively.

[0259] FIG. 2 A illustrates a cross-section of an embodiment of the x-shaped pessary 212 that is formed from a single material.

[0260] In an embodiment, the x-shaped pessary 212 is capable of bending, expanding and supporting, and comprises a rectangular prism-shaped rectangular prism shaped body 206 at its center a plurality of wing elements 208, extending perpendicular to the central axis from the long sides of the body. At the tips of the wings, the device comprises flexible appendages or corners 210, or corners that run parallel to the surface of the body. Between the attachment points of the wing elements 104 to a central spine 254 of the pessary body, and the appendages, there are thin sections 202, in concave, flexible walls 204, that allow for bending. The concave, flexible walls 204 create a thin barrier. The concave, flexible walls 204 provide support to the vaginal walls while helping to maintain the stability of the wing openings.

[0261] More wing elements 208 may be added for added support, however the illustrated embodiment has the particular advantage of two sets of parallel wing elements, spaced such that the shape of the device mimics the X-shape of the vagina.

[0262] The wing elements 208 are fitted to vaginal corners formed by arcus tendinous fascia pelvis, arcus tendinous fascia rectovaginalis and maximum outer transverse diameter that exceeds the transverse diameter in minimal levator hiatus.

[0263] As described with reference to FIG. ID, methods for sizing and designing a pessary, such as the pessary 212 of FIG. 2A, may be based on the patient's pelvic floor ultrasound images, where four transverse lines can be drawn at the minimal hiatal dimensions on an axial image. After making measurements, the pessary 212 may be 3D printed or manufactured using other manufacturing methods (such as injection molding), with custom dimensions.

[0264] In an embodiment, the pessary body 212 and wing elements 208 are made of biocompatible, impermeable, non-toxic materials that exhibit flexible and elastic properties, including, but not limited to, thermoplastic polyurethane, thermoplastic poly elastane, silicone, or any combination thereof.

[0265] The mechanism for expanding, retaining, and bending in the first embodiment of the vaginal pessary is not restricted and can encompass various mechanical and / or material properties.

[0266] FIG. 2B illustrates a side view of an x-shaped pessary 212. Preferably, the x-shaped pessary 212 comprises an elastic supporting core, and a removal hole 118 in core for digit to insert or remove pessary through vaginal canal.

[0267] The x-shaped pessary 212 may further comprise a plurality of corners 214 and edges 216 of the vaginal pessary, which are rounded to facilitate insertion and removal. The removal hole 118 in the rectangular prism shaped body 206 allows for the insertion of the fingertip, and pulling downwards, simultaneously folding the wing elements 208 at the thin sections 202, facilitating the contraction of the pessary into a compressed configuration, for easier removal, and avoidance of abrasion / erosion of nearby tissue. The hole 118 also aids in the separation from the vaginal wall by reducing negative pressure, along with the concave, flexible walls 204.

[0268] Alternatively, a mechanical removal means may be attached through the removal hole 118, providing additional material for a user to pull on, enabling easier removal of the pessary 102. The mechanical removal means may include, but is not limited to, string, floss, hook(s), or an applicator / removal device. These mechanical removal means may be attached to the pessary 102 while in use, or may be employed for the sole purpose of inserting or removing the device, and are not, in that case, permanently attached to the removal hole 118.

[0269] When positioned in the vaginal canal as depicted in FIG. 2C, the deployed x-shaped pessary 212 forms an expanded X shape, effectively supporting the natural X-shaped structure of the vagina. The overall rectangular-prism form of the deployed device registers to the natural shape of the vagina and tissue structures of the pelvic floor. This results in a pessary shape that resists rotation which further aids in its retention.

[0270] Preferably, the design of the vaginal pessary 212 allows for flexibility and adjustable sizing of its wing elements 208, enhancing ease of insertion and passage through the vagina. In a configuration, the body of the pessary is specifically sized to ensure smooth passage, in its folded configuration, through the levator hiatus formed by levator ani muscle as depicted in FIG. 2C. When the wing elements 208 are open, the pessary facilitates in-situ expansion due to its significant axial extension that prevents it from passing through the levator hiatus.

[0271] As depicted in the view of the female urogenital system in FIG. 2C, the x-shaped pessary 212, when positioned within the vagina, effectively mitigates, and counteracts the impact of any prolapsed organ, such as the urinary bladder, uterus, or rectum, by providing comprehensive support and containment within the vaginal cavity or vault.

[0272] The self-deploying action of this device aids in retention as once inserted past the genital hiatus the device expands to feature a cross-section larger than the genital hiatus, which inhibits it from falling out.

[0273] The device also features 4 dedicated registration / anchor points at the corners 210, which make contact with the levator muscles around the introitus, distributing the load.

[0274] FIG. 2D illustrates device customization 242 for an x-shaped pessary 212, for example using a computer program. The measured dimensions may be entered into a computer program, and a schematic of a device may be adjusted on the fly in real-time. The schematic may be sent to manufacture the device, for example through non additive or additive manufacturing processes including injection molding or 3D printing.

[0275] FIG. 2E and FIG. 2F illustrate an embodiment of an x-shaped pessary in a deployed configuration and folded configuration, respectively.

[0276] When the patient is ready to insert the x-shaped pessary 212, they will bend and shrink the wing element 208 using their fingers from the thin sections 202, to form the folded configuration 246. The patient may then insert the x-shaped pessary 212 in its folded configuration 246 into the vagina and push it forward with their finger until it reaches and passes the levator hiatus. Once the levator hiatus is passed, the wing elements 208 will open, and the corners 210 will rest on the sulci of the anterior and posterior vaginal walls, the device in its deployed configuration 244.

[0277] In some embodiments, the x-shaped pessary 212 is configured to be inserted using an applicator device. The applicator device may be configured to receive the pessary 212 in the folded configuration 246. When the patient is ready to insert the x-shaped pessary 212, they can insert the x-shaped pessary 212, in the folded configuration, into the applicator. The coupled pessary and applicator can then be inserted into the patient’s vagina. The pessary can then be ejected from the applicator so that it can expand into its deployed configuration 244. Example applicator devices are discussed in further detail below, for example with respect to FIGS. 13A- 13E.

[0278] The deployed configuration 244 of the various embodiments disclosed herein are generally stable within the vaginal canal, and do not slip out, unless pulled back into the folded configuration 246 by the user.

[0279] When the patient is ready to remove the pessary, they will insert their fingertip in the removal hole 118, or grip a removal loop 222, and pull downwards on the device, causing it to fold into its folded configuration 246.

[0280] FIG. 2G illustrates a perspective view of a variation of an x-shaped pessary 212 in a deployed configuration according to an embodiment.

[0281] The x-shaped pessary 212 may comprise a modified, “H” shape 240 with four wing elements 208, and an additional bridge 226. Unlike the x-shaped pessary 212 as shown in FIG. 2A, the H-shape 240 comprises a hollow center, where concave, flexible walls 204 between the wing elements 208 are formed to support the prolapsed vaginal walls.

[0282] Rectangular prism shaped bridge 226 supports concave, flexible walls 204 to inhibit collapse. Adjusting the wall thickness 232, wall lines 230, layer thickness 228 and infill thickness 238 of the x-shaped pessary 212 can also impact its flexibility and rigidity.

[0283] Multiple attachment points within the internal structure mean it is highly unlikely for the pessary 212 to break into multiple pieces within a user.

[0284] FIG. 2H and FIG. 21 illustrate a first scaffold-x 234, with multiple materials, in a deployed configuration.

[0285] The scaffold structures disclosed herein typically comprise an external structure 252, which in this case forms an X, the external structure 252 having wing elements 208 connected to a central spine 254 by a plurality of scaffold ribs 250.

[0286] Rather than thin, flexible, solid walls, the present embodiment comprises scaffold ribs 250 as the wall, connecting the external structure 252 to the spine 254.

[0287] The internal scaffold ribs 250 may comprise a more rigid, second material 220, when compared with the external structure 252, in order to provide more structure than a flexible, external, first material 218.

[0288] The first scaffold-x 234 may comprise hinges 260 on an inner side off the wing elements 208, at each of the proximal and distal ends of the wing elements, in order to leave room for sliding the scaffold ribs 250, which fit cooperatively into the hinges 260, upwards or downwards towards the proximal end 256 and distal end 258, respectively, during collapse (illustrated in FIG. 2J).

[0289] The second scaffold-x 236 may comprise soft, biocompatible silicone covering all surfaces.

[0290] Other embodiments may comprise one single material.

[0291] FIG. 2J illustrates the first scaffold-x 234 in a collapsed or compressed configuration 224. The inner, second material 220 may slide into the outer first material 218 for easy insertion.

[0292] The first scaffold-x 234 may be removed by pulling on a removal loop 222, collapsing the device into its compressed configuration 224, where it can be seen that the device 234 has a large collapse ratio (between deployed to collapsed cross-sectional area).

[0293] The scaffold-x 234 has many different variations, not only depending on the materials selected, but also depending on whether the external material is covered. It can be quite light, and self-deploying.

[0294] In an embodiment, magnets 248 placed internally and symmetrically at a center of the spine 254 of the scaffold-x 234 may hold the scaffold-x 234 in a deployed configuration during use. The magnets 248 are configured to be oriented to align their opposite poles towards the center of the spine 254. This provides a force that securely holds the spine 254 together, holding the scaffold-x 234 in the deployed configuration. Pulling the magnets 248 apart allows for the scaffold-x 234 to collapse into a folded configuration for removal.

[0295] FIG. 2K illustrates a perspective view of a second scaffold-x 236 device, comprising a single material, which deploys and contracts using the same mechanism of action as the 2- material first scaffold-x 234, but is simpler to manufacture with one single biocompatible material. Scaffold ribs 250 may be cast or printed to be biased to expand into a deployed configuration.

[0296] In the illustrated embodiment, the first scaffold-x 234 comprises four wing elements 208, each defining a corner of a parallelogram-shaped structure.

[0297] The second scaffold-x 236 has a large collapse ratio (between deployed to folded cross-sectional area). It is generally light, and intuitive to insert and remove, similar to other embodiments of the X-structure. It is self-deploying.

[0298] The scaffold-x devices 234 and 236 may comprise removal loops, strings, or hooks, on a lower or distal end 258 (directly opposite a proximal end 256), which a user may pull to collapse the scaffold-x devices 234, 236.

[0299] Pulling on the device(s) in this instinctive manner causes the double parallelogram structure of this device to fold into itself, effectively reducing the cross-section to -35% of its original value, for a more comfortable insertion and removal.

[0300] Alternatively, a finger may be placed in a space between the scaffold ribs 250 and the external structure 252 to pull the device 234, 236 out of a patient.

[0301] The second scaffold-x 236 may be compressed by folding the wing elements 208 over one another. Alternatively, as in the first scaffold-x 234, a pair of hinges 260 on the insides of the wing elements 208 may be employed, sufficiently spaced from one another so that the scaffold ribs 250, cooperatively attached to the hinges 260, can be collapsed into the hinges 260, without the scaffold ribs 250 getting in each other's way.

[0302] The dimensions (length, width, diameter) of the wing elements 208 and corners 214 can be modified to personalize overall dimensions (more trapezoidal shape than cube, distal end larger than proximal or conversely, posterior side larger than anterior side, etc.).

[0303] As noted above, an applicator can be used to ease insertion. The applicator may assist the patient in properly orienting the device such that the device adapts to the specific shape of the vagina (for instance, posterior width larger than anterior width).

[0304] FIGS. 3A-J illustrate various embodiments of unique scaffolded pessary shapes for POP.

[0305] FIG. 3 A illustrates a third scaffold-x device 312 (or pessary 312, used interchangeably), according to an embodiment. This pessary 312 is similar in nature to the second scaffold-x 236 pessaries, having four wing elements 306, each defining a corner 336 of an external 3D structure. The illustrated embodiment portrays a scaffold-x device 312 having four corners 336, each of an equal size, and being each an equal distance from a central spine 304. The wing elements 306 are connected to the central spine 304 by a plurality of scaffold ribs 314 to form a 3D rectangular prism or parallelepiped structure.

[0306] In the illustrated embodiment, scaffold ribs 314 are deployed in pairs. Each respective pair includes a downward facing rib 302 facing towards a distal end 328 of the pessary 312, and an upward facing rib 320 facing towards a proximal end 330 of the pessary 312. The ribs 302 and 320 are angled away from the spine 304 and parallel wing elements 306 at an angle of approximately 30 degrees.

[0307] It is the angle of the scaffold ribs 302, 320 relative to the spine 304, that results in a bias of the device 312 to the deployed configuration.

[0308] The illustrated embodiment has two pairs of scaffold ribs. In other embodiments, more than two ribs or fewer than two ribs may be employed in attaching the wing elements 306 to the spine 304. The more ribs, the greater the rigidity. The number of ribs may be increased / decreased based on severity of a patient’s POP and / or the requirements of the patient.

[0309] In order to fold the pessary along the spine 304, the spine 304 may have a concave divot element 322 configured to receive a protruding, convex muscle element 324 from scaffold ribs 314 during folding. Alternatively, the wing elements 306 may have divots (not pictured in this figure) to receive scaffold ribs 314 during folding.

[0310] FIG. 3B, FIG. 3C, FIG. 3D, FIG. 3E, and FIG. 3F illustrate perspective views of the third scaffold-x device 312, according to different embodiments.

[0311] In an embodiment, the scaffold-x device 312 may have varying corner shapes or wing lengths.

[0312] For example, a scaffold device 312 having four corners 336, the corners 336 at the distal end 328, may be a shorter distance apart than the corners 336 at the proximal end 330. The difference in distance can be attributed to an increase in the diameter / cross-section of the proximal corners 346 or conversely, the distal corners 348.

[0313] Alternatively, the wing elements 306 may have varying lengths. In the illustrated example shown in FIG. 3E and FIG. 3F, the anterior wing elements 344 are shorter in length than the posterior wing elements 342.

[0314] The result is that the wing elements 306 connected to the central spine 304 by a plurality of scaffold ribs 314 form a 3D rectangular prism or parallelepiped structure with a smaller distal end diameter than proximal end diameter and / or a distal corner distance 332 that is less than a proximal corner distance 334, or a longer posterior end versus anterior end, for example.

[0315] The wing elements 306 can be customized to define a more trapezoidal shape of the external 3D structure, by expanding / reducing the distal end’s 328 versus proximal end’s 330 width. The wing elements may also have varying widths. For example, as illustrated in FIG. 3B, FIG. 3C, and FIG. 3D, the wing elements are thicker at the proximal end 330 than the distal end 328.

[0316] It may be preferable to adjust corner size and wing length rather than rib length / size since the size and angle of the ribs to the spine enables an easily foldable and deployable device.

[0317] FIG. 3G illustrates a scaffold saddle device 310 having two wing elements 306 on either side of a central spine 304. The wing elements 306 are connected to the spine 304 by scaffold ribs 314. The scaffold saddle device 310 can have fewer wing elements 306 than other illustrated embodiments. The two corners 360 defining a flatter, rectangular 2D body 326, resulting in a smaller / lighter structure, and enables the addition of an interchangeable knob 338.

[0318] At a distal end 328, the device 310 comprises an interchangeable knob 338, connectable by cooperating a knob connection mechanism 316 and a body connection mechanism 308.

[0319] Preferably, the scaffold saddle device 310 comprises scaffold ribs 314 in pairs having one downward facing rib and one upward facing rib.

[0320] FIG. 3H illustrates a collapsed scaffold saddle device 318. The collapsed scaffold saddle device 318, is collapsible / foldable about its spine 304, by pressing on an external side of the wing elements 306. When inserted into the vagina, it naturally deploys into an expanded state.

[0321] FIG. 31 illustrates a perspective view 358 of a removable interchangeable knob 338. In the illustrated embodiment, the knob 338 includes a curved outer surface. In other embodiments, a knob for a pessary device may include surfaces having different curved geometries.

[0322] FIG. 3 J illustrates a scaffold saddle device 310 from a side view. The body 326, as shown, is connected to another embodiment of the interchangeable knob 338, this one being located more distally compared to the body 326 than that illustrated in FIG. 3H. In other embodiments, the knob 338 is located more proximally compared to the body 326, depending on the specific anatomy of the patient.

[0323] FIG. 3K illustrates a scaffold saddle device 310 from a front view, in deployed configuration, with the interchangeable knob 338 having a greater height than the embodiment illustrated in figure 31. When in compressed configuration the wings 340 are compressed behind the knob 338 to offer the minimal cross sectional area to facilitate insertion as shown in figure 3H. In other embodiments the knob 338 sits lower compared to the body 326 and it ismore integrated in the arms 340 on either side which create more support at the distal end of the pessary.

[0324] FIG. 3L illustrates an interchangeable knob 338 in a posterior cube shape, according to an embodiment, from a rear perspective, illustrating a knob connection mechanism 316, which cooperates with the body connection mechanism 308 when connecting the knob 338 to the pessary body at its distal end.

[0325] The interchangeable knobs 338 are removable and swappable, allowing a doctor or a user to change size, position, tilt of the knob to adapt to urethra position.

[0326] FIGS. 4A-E illustrate a stress urinary incontinence anchor device 406, according to an embodiment.

[0327] Stress Urinary Incontinence (SUI) is characterized by the involuntary leakage of urine during activities such as laughing, coughing, and sneezing, which involve sudden increases in intra-abdominal pressure (IAP). Biomechanically, it is linked to the loss of support in the tissues surrounding the urethra, resulting in the urethra's inability to close and maintain continence during these activities. As intra-abdominal pressure rises, the pressure within the bladder overcomes the resistance of the urethra, leading to leakage. When support from the anterior vaginal wall and connective tissue is weakened, the urethra may become "hypermobile" (i.e., having the ability to move more than the expected normal range of motion).

[0328] FIG. 4 A illustrates an anchor device 406 having a knob 338 for bladder support. In the illustrated embodiment, the knob 338 is permanently affixed at a distal end 428 of the device 406. However, in alternate embodiments such as FIG. 4B, the knob 338 is interchangeable.

[0329] The SUI anchor device 406 further comprises at a distal end 428 of a body 426, mechanical arms 408 on either side of the device's body, the arm 408 being larger than the introital width of a patient for retention above their levator plate, and a stem 410 (oriented superiorly), to prevent the anchor device 406 from rotating into an orientation where it will easily fall out of the patient.

[0330] The stem 410 may comprise a divot 412, located on proximal ends 430 for increased comfort. The divot 412 allows the anchor device 406 to fit below the cervix, when the user is in a supine position.

[0331] The anchor device 406 is easier to fit than other embodiments, due to the arms’ 408 sizing being decoupled from the device width 414.

[0332] FIG. 4B and FIG. 4C illustrates a folding anchor device 416 for SUI support, in its assembled configuration and disassembled configuration, respectively.

[0333] The folding anchor device 416 comprises an interchangeable knob 338 for customizability. The clicking mechanism 404 for folding is incorporated into the mechanical arms 402. A user presses a body 418 into the interchangeable knob 338, causing the arms to fold inwards, and collapsing the device.

[0334] As compared to the anchor device 406, the folding anchor device 416 is easier to remove and insert, due to its decreased diameter.

[0335] Having a removable and interchangeable knob 338 results in customizable bladder support - various sizes, shapes, angles, and positions may be tried on by the patient. The knob 338 may not always be tied to a measurable anatomical property, and allowing the patient to try multiple sizes of the device 416 allows them to find the best fit that meets their needs.

[0336] The anchor device 406 and folding anchor device 416 are preferably of a single material.

[0337] FIG. 4D illustrates another embodiment of a collapsible anchor device 420. The device 420 comprises a long, flat body 422, for increased support, and foldable arms 424. The arms 424 may be pressed inwards in order to compress the device 420, for easy insertion.

[0338] FIG. 4E illustrates a deployed anchor device, inside the vagina, where the increase in intra-abdominal pressure pushes down on top of the stem 410, causing the device to rotate about a pivot point on anchor arms 408 (or mechanical arms 402) and push the knob 338 into the urethra with the divot 412 resting below the cervix.

[0339] The pessary positioned below the cervix acts as lever to push the knob 338 anteriorly, providing dynamic urethral support. The anchor devices 406, 416, 420, have a unique lever mechanism by virtue of their positioning below the cervix with the arms 424 providing an anchor point. As intraabdominal pressure increases, downward force 432 from the cervix pushes on the proximal end of the device body, causing distal end (knob 338) to move upward. As a result, the knob 338 provides an upward force 434 against the urethra, providing support and inhibiting leakage.

[0340] Other designs of the anchor device may comprise similar fulcrum mechanisms for dynamic urethral support (i.e., support when needed, including during movement or a cough for example).

[0341] FIG. 5A-5B illustrates a cube-shaped pessary 502.

[0342] Using design principles according to Jifei Ou, Zhao Ma, Jannik Peters, Sen Dai, Nikolaos Vlavianos, Hiroshi Ishii, kinetiX: Designing auxetic-inspired deformable material structures, Computers & Graphics, Volume 75, 2018, Pages 72-81, ISSN 0097-8493, combined with a patient's particular anatomical characteristics, an external cube shape 502, having a rectangular prism external wall 508, or external “shell,” surrounding and connecting an internal x-shape formed from “hinge elements 504" (similar in shape and mechanical features to the wing elements 208), results in a pessary having a reduced cross-sectional area with living hinge elements 504 running through the axes of the device, allowing for a flexible, auxetic lattice structure possessing unconventional stress-strain behavior. The hinge elements 504 expand laterally when stretched and shrink when compressed (exhibiting a negative Poisson ratio).

[0343] Auxetic patterns are not limited to auxetic materials. While the material itself might not be auxetic, applying certain patterns (like a rotating square pattern, re-entrant honeycomb structure, or other 3D printed configurations) can induce auxetic behavior.

[0344] When external forces are applied at hinge elements 504, they generate a twisting force to prompt the hinge elements 504 to fold inward. Consequently, the ends are also pushed inward, leading to a reduction in the cross-sectional area.

[0345] Increasing the thickness of the hinge elements 504 could enhance the structural stability, reflecting the original X-shaped design, while simultaneously offering flexibility because of the hinge elements 504. Compared to wing elements in the x-design, the hinge elements 504 disclosed herein are more flexible and bendable, and may be connected uniformly to the rest of the device by 3D printing.

[0346] The pessary 502 can be inserted more effectively than prior art pessaries, since the cross-sectional area is smaller.

[0347] As the auxetic pattern allows the pessary to adjust its shape, this could result in a better fit within the patient's anatomy, potentially reducing the risk of device migration or dislodgement.

[0348] The auxetic structure may distribute pressure more evenly, thus reducing localized pressure points that could cause discomfort or tissue damage.

[0349] Other geometric patterns known in the art may be employed in the design or manufacture of the cube-shape 502 with living hinge elements 504, in order to improve structural integrity while maintaining the need for easy insertion and removal of the device.

[0350] FIG. 5B illustrates the cube shape 502 in a compressed configuration 506, where a user presses on the external wall 508 to compress the hinge elements 504, thereby collapsing the device 502 in on itself.

[0351] FIG. 6A and FIG. 6B illustrate another embodiment of the x design pessary - a jellyfish design 602 in its deployed configuration and configuration for insertion, respectively.

[0352] FIG. 6A illustrates a jellyfish design 602 in its deployed configuration. Once the device 602 is inserted, the user pushes and “pops” the internal wall 604 in the center of the external wall 606, to provide wall support. A removal hole 118 hole is included in the center of the device, for a user to insert their finger, first popping out the internal wall 604, thus allowing the device 602 to collapse for easier removal or insertion.

[0353] The illustrated embodiment is advantageous in its use of double layer walls 604, 606, which provide more rigidity thus more support, as compared to single-layered walls, especially if the internal wall 604 is kept in place versus external wall 606 through specific features such as ridges which provide greater rigidity.

[0354] FIG. 6B illustrates a jellyfish design 602 comprising an internal wall 604 “popped” out for insertion and removal.

[0355] FIG. 7 illustrates a c-shape device 704, for SUI-only patients. The c-shape device 704 can have two appendage elements 702, defining a c-shaped proximal end 714 between the arc of the appendage elements 702, to provide support to the urethra. The unique design of the c- shaped distal end allows the device to stay in place while a user is in motion, using the arms 708 at a distal end 716 of the device 704, which rests below the cervix.

[0356] The device 704 is foldable about its body 706, which has a ridge element 712 running down its center and two arms 708 extending out from the body 706 perpendicular to the appendage elements 702. The body 706 and arms 708 are foldable about the ridge element 712 and a thin section 710, situated in between the arms 708.

[0357] FIG. 8 illustrates a bowtie accessory 802 device, configured to provide modular and customizable apical support, for sizing and fitting pessaries.

[0358] The bowtie accessory 802 comprises a plurality of parallel bands 804, 806 that are removably connected at either end of each of the plurality of bands 804, 806 to a retention component 808 at openings in a plurality of corners 810. The plurality of corners 810 form the external shape of the retention component 808.

[0359] There may be two or more bands, and as shown in FIG. 8, the bands 804, 806 need not all be the same length. Extendable bands 804, 806 are configured to independently size the lengths of anterior wall and posterior wall, for example, to account for a user whose anterior wall is longer than their posterior wall.

[0360] The bands may be customized based on user measurements to account for longer anterior walls. The bands may be customized on-site in a room by a clinician cutting them smaller, and inserting them into the openings 812 of corners 810 of the retention component 808.

[0361] The retention component 808 is preferably made of a hollow, flexible and / or foldable material to ease insertion and removal. It is sized so that, when in a collapsed configuration, it fits into the introitus and naturally deploys to an expanded configuration to be larger than the hiatus.

[0362] In some embodiments, the retention component 808 does not receive or hold another pessary device. It would rather be considered a pessary itself if it was used not only for measurement but made to stay longer in the body. In that case, corners 810 of the retention component 808 would have rounder edges, with parallel bands 804, 806 cut to fit, once the right size is determined, and inserted into the openings 812 of the retention component 808. The bands 804 may be glued to the retention component 808 once the right size is determined.

[0363] In an embodiment, the retention component 808 is positioned on the levator plate of a user, and one band 804 is used to measure the length of the posterior wall while one other band 806 is used to measure the length of the anterior wall. After taking measurements, the final pessary may be 3D printed with custom dimensions. Alternatively, the measurements are used to determine the dimensions of a u-pessary, x-pessary, scaffold-x, SUI saddle, etc. as described herein.

[0364] The bowtie accessory 802 may therefore be employed during methods relating to the fitting, testing, and adapting of a pessary device. For example, the bowtie accessory 802 whensimulating a pessary, is inserted in a user's vaginal canal. The fit is assessed by a clinician, and the bands 804, 806 are adapted in length by the clinician and reinserted in the user's vaginal canal, until the right fit is determined to provide the optimal support for each of the compartments of the vagina.

[0365] FIGS. 9A-9H illustrate customizable pessaries. More specifically, the illustrated 2D depictions show various embodiments of the retention component 808 of a bowtie accessory 802. It can be seen that a plurality of different combinations of wing elements, bridges, openings, and the like, may be employed. The embodiments presented in this disclosure should be considered in no way an exhaustive list of the possibilities for design. The pessary devices are highly customizable, may be applicable to a variety of patient needs, and can be combined with various additional supports and removal elements.

[0366] FIG. 10A and FIG. 10B illustrate a perspective view of a foldable chair device in a deployed configuration 1002 and a flattened configuration 1014, respectively, in accordance with one embodiment. The foldable chair device has a past-center mechanism 1004 to allow the device to go from the flattened configuration 1014 for insertion and removal to the deployed configuration 1002.

[0367] When deployed, the device comprises a set of long arms 1006, angled away from a set of short arms 1008, and a set of chair legs 1010 at introitus, preferably sized and configured to be larger than the user's gH, so that the device does not slip out. The chair device may comprise a removal loop 1012, which a user may pull on in order to collapse and subsequently remove the device.

[0368] The chair device is generally thin and lightweight relative to other embodiments, and is preferably manufactured from a single material.

[0369] FIG. 11 A, FIG. 1 IB, FIG. 11C, and FIG. 1 ID illustrate side views (1102, 1106), a perspective view 1104 and a top-down view 1108 of another embodiment of a scaffold x- shaped pessary device, respectively. As shown in the illustrated figure, this embodiment is similar to that of the third scaffold- x 312 device, having four wing elements 1110, each defining a corner 1116 of an external 3D structure. It depicts a scaffold pessary device having four corners 1116, each of an equal size, and being each an equal distance to a central spine 1112. The wing elements 1110 are connected to the central spine 1112 by a plurality of scaffold ribs 1114, forming a 3D rectangular prism or parallelepiped structure.

[0370] In the illustrated embodiment, scaffold ribs 1114 are deployed in pairs. Each pair has a downward facing rib 1118 facing towards a distal end 1128 of the pessary, and an upward facing rib 1120 facing towards a proximal end 1126 of the pessary. The scaffold ribs 1114 are angled away from the central spine 1112 and its parallel wing elements 1110 are disposed at an angle of approximately 30 degrees relative to the central spine 1112. It is this angle that results in bias of the pessary device to transform into its deployed configuration.

[0371] Some embodiments may have more scaffold ribs 1114 which adds to greater rigidity of the pessary device. The number of scaffold ribs 1114 may be increased / decreased based on severity of POP and / or the requirements of the patient. The wing elements 1110 may have a plurality of concave divot elements 1122, each configured to receive a bulbous element 1124 from a respective scaffold rib 1114 when the pessary is folded or compressed. Alternative embodiments may comprise complementary elements similar to that of the concave divot elements 1122 and bulbous elements 1124, which are configured to be nested together when the scaffold x-shaped pessary is folded or compressed.

[0372] FIG. 12A, FIG. 12B, FIG. 12C, and FIG. 12D illustrate perspective views 1202, 1204, a top-down view 1206, and a side view 1208 of a scaffold saddle pessary with a removable interchangeable knob assembly 1210, respectively, in accordance with another embodiment. FIG. 12E and FIG. 12F further illustrate a top-down view and a bottom-up view of the scaffold saddle pessary with reference to the embodiments shown in FIGS. 12A-12D.

[0373] The scaffold saddle pessary has two wing elements 1212. A proximal end scaffold rib 1214 extends between proximal ends of the two wing elements 1212 and a distal end scaffold rib 1216 extend between distal ends of the two wing elements 1212. The proximal end rib 1214 and the distal end rib 1216 have a generally flat central portion. The width of the rib 1214 is smaller near the ends of the rib 1214 that are connected to the wing elements 1212. Similarly, the width or the rib 1216 is smaller near the ends of the rib 1216 that are connected to the wing elements 1212. The decrease in the widths of ribs 1212, 1216 may enable the pessary device to fold.

[0374] Extending perpendicularly from the central portion of the distal rib 1216 are two arms 1218. The arms 1218 define a gap therebetween which is clearly illustrated in FIG. 12E and FIG. 12F.

[0375] The knob assembly 1210 includes a knob 1226 and a central spine 1220 that extends from the knob 1226. The proximal end of the central spine 1220 includes an indented engagingmember 1222. When the knob assembly 1210 is coupled to the pessary, the engaging member 1222 connects or otherwise engages with the proximal end scaffold rib 1214, and the distal end 1224 of the central spine 1220 is positioned in the gap defined between the arms 1218 by rotating the knob assembly 1210, clicking it in place within the gap between the arms arm 1218.

[0376] The knob 1226 has an approximately cylindrical geometry that is configured to provide support to a user’s urethra when the pessary is inserted. The knob 1226 can be truncated at one quarter of its radius to limit the size of the pessary to facilitate insertion and minimize user discomfort by restricting the weight of the pessary.

[0377] The interchangeable knob assembly 1210 is removable and swappable, allowing a doctor or a user to change size, position, tilt of the knob to adapt to a urethra position. Different knob assemblies may include knobs with different features (e.g., different geometries, weights, etc.) than the knob 1226 of the knob assembly 1210.

[0378] FIG. 12G and FIG. 12H illustrates perspective views of additional example scaffold saddle pessaries, each with a removable interchangeable knob assembly (1228, 1230). Similarly to FIG. 12 A, the scaffold saddle pessaries shown in FIG. 12B each have two wing elements 1232, distal end scaffold ribs 1234, and proximal end scaffold ribs 1236. However, the scaffold ribs have a different configuration in that they are relatively wider. The proximal end scaffold rib 1236 of each pessary has a generally flat central portion. Extending from the flat central portion to the wing elements 1232 are inverted scalene triangular portions. The distal end scaffold rib 1234 of each pessary has the same width as that of the proximal end scaffold rib 1236 between the two wing elements 1212.

[0379] Each knob assembly (1228, 1230) includes a knob 1240 and a central spine 1238 that extends from the knob 1240. When each knob assembly (1228, 1230) is coupled to its respective pessary, the distal end of the central spine 1238 of the knob assembly (1228, 1230) is configured to engage with the distal end scaffold rib 1234 on the respective pessary and the proximal end of the central spine 1238 is configured to engage with the proximal end scaffold rib 1236 on the respective pessary.

[0380] The knob 1240 has an approximately cylindrical geometry that is configured to provide support to a user’s urethra when the pessary is inserted. The knob 1240 can be truncated at one quarter of its radius to limit the size of the pessary to facilitate insertion and minimize user discomfort by restricting the weight of the pessary.

[0381] The knob assemblies (1228, 1230) are removable and swappable. This interchangeability allows a doctor or a user to change size, position, tilt of the knob to adapt to a urethra position. In some embodiments, a knob assembly for a pessary device can include knobs with shapes different than those shown in FIG. 12G and FIG. 12H, for example, knobs that have a droplet shape.

[0382] FIG. 121 shows a perspective view of another embodiment 1260 of a scaffold saddle pessary device. The pessary device 1260 includes a pair of wing elements 1262, a knob 1264, a plurality of ribs 1266, and a central spine 1268. The central spine 1268 is positioned between the pair of wing elements 1262.

[0383] The plurality of ribs 1266 extend between and connect the central spine 1268 and the wing elements 1262. In the illustrated embodiment, each rib 1266 is angled toward the distal end of the pessary device 1260 and is thinner adjacent to the point where the rib connects to the central spine 1268 to facilitate folding of the pessary device 1260. In other embodiments, the plurality of ribs 1266 includes a plurality of pairs of ribs extending between a different one of the wing elements and the central spine, and each pair of ribs includes a distal-facing rib that is angled toward the distal end of the pessary device and a proximal-facing rib that is angled toward the proximal end of the pessary device.

[0384] The knob 1264 includes a curved outer surface 1280. In the illustrated embodiment, the curved surface 1280 is saddle shaped. The curved surface 1280 curves proximally along a direction perpendicular to the central spine 1268 and curves distally along a direction parallel to the central spine 1268. In other embodiments, a knob for a pessary device may include surfaces having different curved geometries, for example a surface having uniform curvature.

[0385] In other embodiments, an interchangeable knob is approximately cylindrical in shape and has a diameter of between 15 mm and 30 mm (e.g., a diameter of approximately 16 mm, 18 mm, 20 mm, 22 mm, 24 mm, 26 mm, or 28 mm). The outer surface of the knob can include a depressed flat portion that extends approximately 2 mm along the outer surface of the knob.

[0386] The knob 1264 is removably coupled to the distal end of the central spine 1268. As shown in FIG. 12J, a connector comprising a pair of notches 1270, 1272 extends from the distal end of the central spine 1268. The first notch 1270 is formed on a first side of the connector and the second notch 1272 is formed on a second side of the connector that is opposite the first side. In the illustrated embodiment, the first notch 1270 is longitudinally offset from the second notch 1272. The longitudinal offset distance between the notches 1270, 1272 can be between2.5 mm and 7.5 mm, for example about 3 mm, about 4 mm, about 5 mm, about 6 mm, or about 7 mm.

[0387] The knob 1264 is configured to engage with the notches 1270, 1272. As shown in FIG. 12K a channel 1278 is formed in a rear surface of the knob 1264. A pair of protrusions 1274, 1276 extend into the channel 1278 from either side. The protrusion 1274 is configured to engage with the connector notch 1270 and the protrusion 1276 is configured to engage with the connector notch 1272 to affix the knob 1264 to the central spine 1268.

[0388] As discussed above, the disclosed pessary devices can be configured to be inserted using an applicator device. FIG. 13 A illustrates a perspective view of a pessary applicator device 1302 with its components disassembled applicator 1302, in accordance with one embodiment.

[0389] The illustrated applicator 1302 comprises three components: a cover sleeve 1314, insert 1312, and plunger 1310. As discussed in further detail below, the insert 1312 is configured to seat a folded pessary device within the sleeve 1314, and the plunger 1310 is configured to slide relative to the insert to contact a seated pessary device to deploy the pessary device from the sleeve, thereby causing the pessary device to transform from the folded configuration to a deployed configuration.

[0390] In the illustrated embodiment, the plunger 1310 is approximately key-shaped and comprises a grip 1316 and a cylindrical shaft 1318. The grip 1316 is configured to be held by a user who is inserting the pessary device. In the illustrated embodiment, the grip 1316 is a loop that is configured to receive at least one of the user’s fingers. The cylindrical shaft 1318 comprises two sets of grooves 1320, 1322 along its length that are connected by a third groove (not shown). The first set of grooves 1320 is formed in a distal end portion of the cylindrical shaft 1318 adjacent to the grip 1316. The second set of grooves is formed in a proximal end portion of the cylindrical shaft 1318 and comprises grooves that are shorter than those of the first set of grooves.

[0391] The insert 1312 is configured to maintain a pessary device in a proper folded configuration for insertion into the vagina. The insert 1312 defines a central hole 1330. A pair of notches 1332 extend between a distal-facing face of the insert 1312 and a proximal-facing face of the insert are formed in an outer surface of the insert 1312. Each notch 1332 narrows toward the proximal-facing face of insert 1312, forming a groove 1334.

[0392] FIGS. 13B-13D show various additional views of the insert 1312. As illustrated in the distal-facing view 1304 of the insert 1312 (FIG. 13B), a pair of protrusions 1340 extend into the central hole 1330 of the insert 1312. As shown in the proximal-facing view 1306 of the insert 1312 (FIG. 13C), the proximal-facing face of the insert 1312 includes a pessary seat 1342 comprising the proximal opening of the central hole 1330 and a plurality of cavities 1344. As illustrated in the side view 1308 of the insert 1312 (FIG. 13D), a second pair of notches 1358 are formed adjacent to a distal-facing face of the insert 1312.

[0393] The sleeve 1314 defines a lumen and includes a distal opening 1326 and a proximal opening 1328. The area of the proximal opening 1328 is smaller than the area of the distal opening 1326, and the transverse cross-sectional area of the sleeve 1314 narrows between the proximal opening 1328 and the distal opening 1326. In the illustrated embodiment, the transverse cross-sectional shape of the sleeve 1314 is round-cornered rectangle. In other embodiments, the transverse cross-sectional shape of a sleeve for a pessary applicator device can be another polygon or polygon-like shape, for example a round-cornered trapezoid or a round-cornered square. A pair of notches 1324 are formed on the outer surface of the sleeve 1314 adjacent to the distal opening 1326. The sleeve 1314 can be formed from a rigid material, a flexible material, or a combination thereof.

[0394] To assemble the applicator device and insert the pessary, the plunger 1310 is first slidably inserted into the central hole 1330 of the insert 1312 such that the cylindrical shaft 1318 of the plunger 1310 extends through the central hole 1330. When the plunger 1310 is inserted into the central hole 1330 of the insert 1312, the protrusions 1340 engage with the second set of grooves 1322 formed in the cylindrical shaft 1318 of the plunger 1312. In some embodiments, grooves 1320, 1322 are shaped such that, after insertion into the central hole 1330, the plunger 1312 must be rotated approximately ninety degrees clockwise (or counterclockwise) in order to engage the grooves 1322 with the protrusions 1340.

[0395] Once the plunger 1310 is inserted into the central hole 1330, the pessary device, in its folded configuration, can be seated in the pessary seat 1342 of the insert 1312. The plurality of cavities 1344 are configured to seat distal end portions of a respective plurality of wing elements on the pessary device when the pessary device is in its folded configuration, and the proximal opening of the central hole 1330 is configured to seat a distal end portion of the central spine of the pessary device.

[0396] In some embodiments, the central spine of the pessary device may include a transverse through-hole. To seat the pessary in the pessary seat 1342 of the insert, the user can thread a string through the transverse through-hole in the central spine of the pessary, then pull both ends of the string toward the distal end of the pessary to apply a longitudinal pulling force to the central spine. This pulling force may transform the pessary to its folded configuration. The user can maintain the pessary in the folded configuration by holding the ends of the string taught while inserting the distal end portions of the wing elements into the cavities 1344 of the pessary seat 1342. To prevent tangling of the string, the ends of the string can be positioned within the grooves 1334 in the outer surface of the insert 1312.

[0397] As shown in FIG. 13E, a coupled pessary device 1352, insert 1312, and plunger 1310 together form a pessary, insert, and plunger assembly 1354. The assembly 1354 can be inserted through the distal opening 1326 of the cover sleeve 1314 such that the pessary device and the insert 1312 are positioned within the lumen defined by the cover sleeve 1314. The inner surface of the sleeve 1314 can be configured to engage with the notches 1358 near the distal-facing face of the insert 1312 to secure the sleeve 1314 to the insert 1312.

[0398] Inserting the coupled pessary, insert 1312, and plunger 1310 in the sleeve 1314 may require aligning the notches 1324 on the outer surface of the sleeve 1314 with the notches 1332 in the outer surface of the insert 1312. Requiring such alignment of the notches 1324, 1332 may ensure that the pessary is properly oriented when it is inserted. The narrowing of the transverse cross-sectional area of the sleeve 1314 forces the pessary to remain in the folded configuration.

[0399] After the assembly 1354 is inserted into the sleeve 1314, the applicator is fully assembled and can be inserted into a vaginal canal of a patient. To deploy the pessary device from the applicator, the plunger 1310 is depressed into the central hole 1330 of the insert, as shown in view FIG. 13F. As the plunger 1310 slides through the central hole 1330 relative to the insert 1312, it engages with the central spine of the pessary 1352 and pushes the pessary from the pessary seat 1342, thereby ejecting the pessary through the proximal opening 1328 of the sleeve 1314. The pessary device 1352 automatically transforms into its deployed configuration as it passes through the proximal opening 1328 of the sleeve 1314, as shown in FIG. 13G.

[0400] After the pessary device is deployed, the applicator device can be removed from the user’s vaginal canal and disassembled. The sleeve 1314 can be decoupled from the insert 1312 and the plunger 1310 by compressing the notches 1324 on the outer surface of the sleeve 1314to cause the inner surface of the sleeve 1314 to disengage from the notches 1358 in the insert 1312. After the sleeve 1314 is decoupled, the plunger 1310 can be removed from the central hole 1330 of the insert 1312.

[0401] The deployed pessary device can be removed from the user’s vaginal canal by transforming the pessary device to the folded configuration and sliding the pessary device out of the canal. The pessary device can be transformed to the folded configuration by applying a longitudinal pulling force to the central spine. In embodiments where the central spine includes a transverse through-hole through which a string was threaded prior to insertion of the pessary, this pulling force can be applied by pulling the ends of the string.

[0402] FIG. 14A illustrates a side view of an x-shaped pessary 1408 in a deployed configuration, in accordance with another embodiment. Similar to the embodiment depicted in FIG. 2D, the illustrated embodiment has four wing elements 1402, 1404 and a central body 1406. However, although symmetric around a central axis, the dimensions of the wing elements 1402, 1404 are not equal in that there are two short wing elements 1402 and two long wing elements 1404. The configuration of this x-shaped pessary 1408 allows for a different mechanism by which it can be folded or compressed as compared to the other x-shaped pessary devices described previously.

[0403] FIG. 14B illustrates a side view of the x-shaped pessary 1408 in a folded configuration. The x-shaped pessary 1408 is folded such that the short wing elements 1402 are first folded into the central body 1406 towards the direction of the long wing elements 1404. Once the short wing elements 1402 are folded, the user transiently holds them in place and subsequently folds the long wing elements 1404 into the central body 1406 towards the direction of the short wing elements 1402. When all wing elements 1402, 1404 are in their folded configuration, the x-shaped pessary 1408 is ready to be inserted into the vagina either directly using a user's fingers or with assistance of an applicator.

[0404] FIG. 15A illustrates a perspective view of a pessary applicator device 1502 in use to deploy an x-shaped pessary 1408, in accordance with another embodiment. In this embodiment, the pessary applicator device 1502 comprises an insertion end 1506, a deployment end 1508, a tapered rectangular shaped body with a hollow center, and a notch 1510 on one side of the insertion end 1506. The notch 1510 increases the extent to which the pessary can be pushed out of the applicator 1502.

[0405] Once a pessary is in its folded configuration 1504 after the user folds it as shown in FIG. 14B, a user can insert it into insertion end 1506 of the applicator device 1502, and push it forward with their finger or fingers through the hollow body for it to be released through the deployment end 1508 of the applicator device. The user may also use a lubricant to help facilitate the insertion and deployment of the x-shaped pessary into the vagina. In some embodiments, the applicator device 1502 may be used with pessaries comprising different structures, dimensions, and / or configurations.

[0406] FIG. 15B illustrates a perspective view of a pessary applicator device 1502 that has deployed a deployed x-shaped pessary device 1512, in accordance with another embodiment. In this embodiment, the deployed x-shaped pessary device 1512 is shown to have a small hole 1514 at a distal end of its central body in which a loop 1516 is inserted. This loop 1516 is configured to be a means for the user to remove the deployed x-shaped pessary device 1512 from the vagina. The user can grip the loop 1516 and pull it to have the deployed x-shaped pessary device 1512 change to a compressed configuration through the vaginal canal before changing back to its deployed configuration once it is outside the vagina.

[0407] FIG. 16 shows a method 1600 for inserting a disclosed pessary device using a disclosed pessary applicator device. The depicted embodiment of the method 1600 is provided as an example; it will be apparent to those skilled in the art that, in other embodiments, one or more of the steps of the method 1600 may be omitted, one or more steps may be added to the method 1600, or one or more steps of the method 1600 may be performed in a different order than that which is shown in FIG. 16.

[0408] In a step 1602, a plunger is slidably inserted into a central through-hole of an insert to form a plunger assembly. Slidably inserting the plunger into the central through-hole of the insert may involve inserting a protrusion extending from an internal surface of the central through-hole into a corresponding groove formed in a proximal end portion of the plunger.

[0409] In a step 1604, a distal end portion of a pessary device is joined into a corresponding cavity of a face of the insert to couple the pessary device to the plunger assembly. Prior to inserting the distal end portion of each of the plurality of wing elements into the corresponding cavity of the face of the insert, a plurality of wing elements of the pessary device may be folded about a central spine of the pessary device.

[0410] In a step 1606, the coupled pessary device and plunger assembly are inserted through a lumen of a cover sleeve to couple the plunger assembly to the cover sleeve to form anapplicator assembly. A first notch formed in an outer side surface of the insert may be aligned with a second notch formed in an outer surface of the cover sleeve prior to inserting the coupled pessary device and plunger assembly through the cover sleeve.

[0411] In a step 1608, the applicator assembly and pessary device are inserted into a vaginal canal of a patient. In a step 1610, the plunger is slid through the central through-hole relative to the insert to deploy the pessary device into the vaginal canal through a proximal end of the cover sleeve. Deploying the pessary transforms the pessary device from a folded configuration to a deployed configuration such that the plurality of wing elements of the pessary device unfold relative to the central spine.

[0412] In some embodiments, following step 1610, the applicator assembly is removed from the vaginal canal, and the plunger assembly is decoupled from the cover sleeve. Decoupling the plunger from the cover sleeve can involve compressing a pair of notches formed in opposing outer side surfaces of the cover sleeve and sliding the plunger distally from the central through- hole.

[0413] In some embodiments, following step 1610, while the pessary device is disposed in the vaginal canal, the plurality of wing elements of the pessary device is re-folded about the central spine to transform the pessary device from the deployed configuration to the folded configuration. Re-folding the pessary device may comprise applying a longitudinal pulling force to the central spine of the pessary device. The pessary device is then removed from the vaginal canal.

[0414] The materials disclosed herein are preferable biocompatible, and easy to clean, with inaccessible gaps avoided in the design and manufacture of the various devices.

[0415] Any of the devices described herein may be sized and configured to a particular user, using the methods described in FIG. ID, as well as clinician measurements, hand tool measurements, sensor measurements, and the like.

[0416] Methods for sizing and designing a pessary may be based on the patient's pelvic floor ultrasound images, where four transverse lines are drawn at the minimal hiatal dimensions on axial image. After making measurements, the pessaries may be 3D printed with custom dimensions.

[0417] The inherent flexibility and relatively low surface area of the devices disclosed herein allow for them to move with a user, therefore reducing tissue abrasion and reducing discharge in the patient.

[0418] Other device parameters that may be adjusted may include, but are not limited to, additional webbing or scaffold ribs, in order to increase stability, adaptation of the core diameter, increased thickness, to increase support, and the like.

[0419] The devices may be adaptable for easier manufacturing, easier personalization, and / or mass manufacturing (based on averages of user dimensions).

[0420] The devices disclosed herein may incorporate an applicator to ease insertion. Applicators may comprise off-the-shelf designs or may be custom-made for a user.

[0421] The devices disclosed herein may incorporate a string or tactile feature to ease removal.

[0422] Length is typically related to the total vaginal length.

[0423] In addition to the ultrasound measurements disclosed above, a clinician may combine user measurements and other anatomical dimensions from other methods and measurements.

[0424] Measurements performed by a clinician and included in the determination of device dimensions, may include one or more of the user's anatomy and / or measurements of the user’s physical characteristics such that one or more characteristics such as the dimensions of the user’s major anatomical structures, anatomical geometry, etc. are defined. For example, a Pelvic Organs Prolapse Quantification (POP-Q) may be performed, this being a standardized tool for documenting the examination findings recognized by International Continence Society (ICS) and International Urogynecological Association (IUGA). Within the POP-Q system six principal landmarks are defined to describe the degree (quantity) of Pelvic Organ Prolapse (POP). These points (Aa, Ba, C, D, Ap, Bp) are located on vaginal walls and cervix and are related to the hymen which is considered a fixed point of reference. Another three distances (GH, TVL, and PB) may also be defined for more detailed description. The “stage” of prolapse is typically defined according to the evaluation of these points. These nine points are defined by letters Aa, Ba, C, D, Ap, Bp, GH, TVL, and PB respectively, these being:• Point Aa: This point is located in the midline anterior vaginal wall approximately 3cm proximal from the external urethral meatus. The range of its position relative to hymen is typically from -3cm to +3cm.• Point Ba: The most distal position of any part in the anterior vaginal wall from the vaginal cuff or anterior vaginal fornix to Point Aa. In absence of prolapse, this point is at - 3cm.• Point C: The most distal edge of the cervix or vaginal cuff (hysterectomy scar) after total hysterectomy.• Point D: Represents the pouch of Douglas or the location of posterior vaginal fornix. It is also a point of measurement for differentiation apical compartment prolapse from cervical elongation. Accordingly, in the absence of a cervix point D is omitted.• Point Ap: Located in the middle of posterior vaginal wall 3cm proximal to the hymen. The range of its position relative to hymen is typically from -3cm to +3cm.• Point Bp: Represents the most distal position of any part in the posterior vaginal wall from the vaginal cuff or posterior vaginal fornix to point Ap.• Genital hiatus (gH): The distance between external urethral meatus and posterior margin of the hymen.• Total Vaginal Length (TVL): The deepest length of the vagina (cm) measured when point D (or the vaginal cuff) are reduced to normal position.• Perineal Body (PB): The distance measured from posterior margin of the hymen to the mid-anal opening.

[0425] All measurements are taken on Valsalva except TVL. A clinician may employ a manual procedure to measure the basic six or full nine points Aa, Ba, C, D, Ap, Bp, GH, TVL, and PB, respectively. This may be via the use of a ruler, swab, or other mechanical measuring device. The necessary user-specific structural / anatomical parameters may also be derived from one or more imaging techniques including, but not limited to, ultrasound imaging, magnetic resonance imaging (MRI), elastography, acoustic analysis, tactile imaging, photoacoustic (optoacoustic) imaging, tomography, echocardiography, functional near-infrared spectroscopy, and electrical impedance tomography. Alternatively, mechanical based devices may be employed to perform measurements and / or support one or more transducers for one or more imaging techniques, manual processes etc. Further these measurements may be at least one intravaginal, translabial, and transperineal.

[0426] Within embodiments of the invention the custom pessaries may be employed in combination with other therapies and / or pharmaceutical coatings etc. in order to combine a custom USTD with regenerative medicine. Accordingly, within other embodiments of the invention a USTD according to an embodiment of the invention may exploit an energy delivery system such as electrical stimulation, infrared irradiation or ultraviolet irradiation for example. A custom USTD may also be employed in conjunction with other medical procedures and / ortreatment regimens including, for example, exploitation of biological therapies including recombinant proteins, recombinant peptides, and stem cells for example.

[0427] The devices disclosed herein may be provided or embedded with, wearable devices and / or sensors. The wearable devices and / or wearable sensors may include, but not be limited to, devices that can stimulate and / or measure parameters related to the function of the vagina, urethra, uterus, bladder, cervix, rectum, anal sphincter, urethral sphincter, and abdominal cavity. It may also be used to measure intra-abdominal pressure which can be correlated to the amount of force that a pessary will need to support.

[0428] The pessaries and SUI devices disclosed herein may be designed using computer implemented technologies.

[0429] Various materials may be employed in the manufacture of the pessaries and their applicators, including, but not limited to resins, polymers, polyesters, thermoplastics, aramids, silicone, elastomers, and the like.

Claims

CLAIMSWhat is claimed is:

1. A pessary device comprising: a central spine; and four wing elements positioned around and connected to the central spine, each of the four wing elements configured to be folded relative to the central spine to transform the pessary device between a deployed configuration and a folded configuration, wherein, when the pessary device is in the deployed configuration, the central spine and the four wing elements together form a three-dimensional structure having an x-shaped transverse cross-section.

2. The pessary device of claim 1, further comprising four walls each connecting a respective wing element to the central spine.

3. The pessary device of claim 2, wherein each wall of the four walls is concave.

4. The pessary device of claim 2, wherein each wall of the four walls is configured to be folded such that a connected wing element is also folded about the central spine.

5. The pessary device of claim 1, wherein the central spine is hollow, and the pessary device further comprises a bridge extending between a first internal surface of the central spine and a second internal surface of the central spine that is opposite the first internal surface.

6. The pessary device of claim 5, wherein the bridge is shaped like a rectangular prism.

7. The pessary device of claim 1, further comprising at least four ribs, at least one rib extending between each wing element and the central spine.

8. The pessary device of claim 7, wherein the at least four ribs comprise four pairs of ribs, each pair of ribs extending between a different one of the four wing elements and the central spine.

9. The pessary device of claim 8, wherein each of the four pairs of ribs comprises: a distal-facing rib angled toward a distal end of the central spine; and a proximal-facing rib angled toward a proximal end of the central spine.

10. The pessary device of claim 7, wherein the four wing elements are formed from a first material and the at least four ribs are formed from a second material that is more rigid than the first material.

11. The pessary device of claim 7, wherein each of the at least four ribs comprise a convex muscle element.

12. The pessary device of claim 11, wherein the central spine comprises at least four divots, each divot being positioned adjacent to a rib of the at least four ribs and configured to receive the convex muscle element of the rib when the pessary device is in the collapsed configuration.

13. The pessary device of claim 11, wherein each of the four wing elements comprises a divot, wherein, when the pessary device is in the collapsed configuration, each divot of each wing element is configured to receive the convex muscle element of a rib of the at least four ribs that extends between the wing element and the central spine.

14. The pessary device of claim 7, wherein at least two of the four ribs have different widths.

15. The pessary device of claim 7, wherein at least two of the four ribs have different thicknesses.

16. The pessary device of claim 1, wherein the four wing elements have equal lengths.

17. The pessary device of claim 1, wherein at least two of the four wing elements have different lengths.

18. The pessary device of claim 17, wherein a first wing element and a second wing element of the four wing elements have a first length, and a third wing element and a fourth wing element of the four wing elements have a second length that is less than the first length.

19. The pessary device of claim 1, wherein a thickness of each wing element of the four wing elements varies along a longitudinal axis of the wing element.

20. The pessary device of claim 1, wherein, in the collapsed configuration, a transverse cross- sectional area of the pessary device is between 30% and 50% smaller than the transverse cross- sectional area of the pessary device in the deployed configuration.

21. The pessary device of claim 1, wherein the pessary device is configured to be inserted into a vagina of a patient to mitigate prolapse of an organ of the patient or to mitigate incontinence.

22. The pessary device of claim 1, wherein the four wing elements are configured to collapse toward the central spine when a longitudinally-directed force is applied to the central spine.

23. A pessary device comprising: a central spine; a plurality of wing elements positioned on opposed sides of the central spine, each of the plurality of wing elements being configured to be folded about the central spine to transform the pessary device from a deployed configuration to a folded configuration; a connector positioned between respective distal ends of the plurality of wing elements; and a knob coupled to a connector.

24. The pessary device of claim 23, wherein the knob is removably coupled to the connector.

25. The pessary device of claim 23, wherein the knob comprises a curved surface.

26. The pessary device of claim 25, wherein the curved surface is saddle shaped.

27. The pessary device of claim 26, wherein the curved surface curves distally along a direction perpendicular to the central spine and curves proximally along a direction parallel to the central spine.

28. The pessary device of claim 25, wherein the curved surface is uniformly curved.

29. The pessary device of claim 23, wherein the pessary device is configured to be inserted into a vagina of a patient, wherein, when the pessary device is inserted into the vagina, the knob is configured to provide support to a urethra of the patient.

30. The pessary device of claim 23, wherein the plurality of wing elements are connected to the central spine.

31. The pessary device of claim 30, wherein the connector extends from a distal end of the central spine.

32. The pessary device of claim 31, wherein the connector comprises: a first notch formed in a first side of the connector; and a second notch formed in a second side of the connector opposite the first side, wherein the knob couples to the first and second notches.

33. The pessary device of claim 32, wherein the first notch and the second notch are laterally aligned.

34. The pessary device of claim 32, wherein the first notch is at least partially longitudinally offset from the second notch.

35. The pessary device of claim 32, wherein the first notch is longitudinally offset from the second notch by between 2.5 mm and 7.5 mm.

36. The pessary device of claim 30, further comprising a plurality of ribs, each rib extending between one of the plurality of wing elements and the central spine.

37. The pessary device of claim 36, wherein the plurality of ribs comprises a plurality of pairs of ribs, each pair of ribs extending between a different one of the plurality of wing elements and the central spine.

38. The pessary device of claim 37, wherein each of the plurality of pairs of ribs comprises: a distal-facing rib angled toward a distal end of the central spine; and a proximal-facing rib angled toward a proximal end of the central spine.

39. The pessary device of claim 23, wherein the central spine extends from the knob.

40. The pessary of claim 23, wherein the plurality of wing elements are connected to the connector.

41. The pessary of claim 40, wherein the connector comprises a pair of arms defining a gap therebetween, wherein a portion of the central spine adjacent to the knob is positioned in the gap when the knob is coupled to the connector.

42. The pessary device of claim 39, further comprising a rib that extends between proximal portions of the plurality of wing elements.

43. The pessary device of claim 42, wherein the distal end of the central spine comprises an indent that engages with the rib when the knob is removably coupled to the connector.

44. A system, comprising: a pessary device comprising: a central spine, and a plurality of wing elements disposed around and connected to the central spine, the wing elements being movable toward and away from to transform the pessary device between a deployed configuration and a folded configuration; and an applicator, comprising: a cover sleeve, an insert defining a central hole therethrough and having a face corresponding to a form of the pessary device in the folded configuration, the insert being configured to seat the pessary device on the face and within the lumen of the sleeve, and a plunger configured to extend through the central hole and contact a seated pessary device, the plunger being configured to slide relative to the insert to deploy the pessary device from the sleeve, thereby causing the pessary device to transform from the folded configuration to the deployed configuration.

45. The system of claim 44, wherein the face of the insert is configured to seat a portion of the central spine and each of the plurality of wing elements.

46. The system of claim 44, wherein a distal end of the plunger comprises a loop configured to receive a user’s finger.

47. The system of claim 44, wherein the cover sleeve comprises a flexible material, a rigid material, or a combination thereof.

48. The system of claim 44, wherein the cover sleeve includes a distal opening and a proximal opening, and wherein an area of the proximal opening is smaller than an area of the distal opening.

49. The system of claim 44, wherein a transverse cross-sectional shape of the cover sleeve is a round-cornered rectangle, a round-cornered square, or a round-cornered trapezoid.

50. The system of claim 44, wherein: the face comprises a first notch formed in an outer surface thereof; the cover sleeve comprises a second notch formed in an outer surface thereof; and the first notch and the second notch are configured to be aligned when the insert is coupled to the cover sleeve.

51. The system of claim 44, wherein the pessary device comprises four wing elements.

52. The system of claim 51, wherein the pessary device further comprises at least four ribs, at least one rib extending between each wing element and the central spine.

53. The system of claim 52, wherein the at least four ribs comprise four pairs of ribs, each pair of ribs extending between a different one of the four wing elements and the central spine.

54. The system of claim 53, wherein each of the four pairs of ribs comprises: a distal-facing rib angled toward a distal end of the central spine; and a proximal-facing rib angled toward a proximal end of the central spine.

55. The system of claim 52, wherein the four wing elements are formed from a first material and the at least four ribs are formed from a second material that is more rigid than the first material.

56. The system of claim 52, wherein each of the at least four ribs comprises a convex muscle element.

57. The system of claim 56, wherein the central spine comprises at least four divots, each divot being positioned adjacent to a rib of the at least four ribs and configured to receive the convex muscle element of the rib when the pessary device is in the collapsed configuration.

58. The system of claim 56, wherein each of the four wing elements comprises a divot, wherein, when the pessary device is in the collapsed configuration, each divot of each wing element is configured to receive the convex muscle element of a rib of the at least four ribs that extends between the wing element and the central spine.

59. The system of claim 44, wherein the plurality of wing elements have equal lengths.

60. The system of claim 44, wherein at least two of the plurality of wing elements have different lengths.

61. The system of claim 60, wherein a first wing element and a second wing element of the plurality of wing elements have a first length, and a third wing element and a fourth wing element of the plurality of wing elements have a second length that is less than the first length.

62. The system of claim 44, wherein, in the collapsed configuration, a transverse cross- sectional area of the pessary device is between 30% and 50% smaller than the transverse cross- sectional area of the pessary device in the deployed configuration.

63. The system of claim 44, wherein the plurality of wing elements are configured to collapse toward the central spine when a longitudinally-directed force is applied to the central spine.

64. A method comprising: slidably inserting a plunger into a central through-hole of an insert to form a plunger assembly; joining a distal end portion of a pessary device into a corresponding cavity of a face of the insert to couple the pessary device to the plunger assembly; inserting the coupled pessary device and plunger assembly through a lumen of a cover sleeve to couple the plunger assembly to the cover sleeve to form an applicator assembly; inserting the applicator assembly and pessary device into a vaginal canal of a patient; and sliding the plunger through the central through-hole relative to the insert to deploy the pessary device into the vaginal canal through a proximal end of the cover sleeve.

65. The method of claim 64, wherein slidably inserting the plunger into the central through- hole of the insert comprises inserting a protrusion extending from an internal surface of the central through-hole into a corresponding groove formed in a proximal end portion of the plunger.

66. The method of claim 64, further comprising: folding a plurality of wing elements of the pessary device about a central spine of the pessary device prior to inserting the distal end portion of each of the plurality of wing elements into the corresponding cavity of the face of the insert.

67. The method of claim 66, wherein deploying the pessary transforms the pessary device from a folded configuration to a deployed configuration such that the plurality of wing elements of the pessary device unfold relative to the central spine.

68. The method of claim 67, further comprising: while the pessary device is disposed in the vaginal canal, re-folding the plurality of wing elements of the pessary device about the central spine to transform the pessary device from the deployed configuration to the folded configuration; and removing the pessary device from the vaginal canal.

69. The method of claim 68, wherein re-folding the plurality of wing elements comprises applying a longitudinal pulling force to the pessary device.

70. The method of claim 64, further comprising: aligning a first notch formed in an outer side surface of the insert with a second notch formed in an outer surface of the cover sleeve prior to inserting the coupled pessary device and plunger assembly through the cover sleeve.

71. The method of claim 64, further comprising: removing the applicator assembly from the vaginal canal; and de-coupling the plunger assembly from the cover.

72. The method of claim 71, wherein de-coupling the plunger assembly from the cover sleeve comprises simultaneously: compressing a pair of notches formed in opposing outer side surfaces of the cover sleeve; and sliding the plunger distally from the central through-hole.

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