Systems and methods for custom-designing a gynecological prosthetic

Abstract

A method of custom designing a gynecological prosthetic for a patient, the method configured to be executed by at least one processor of a computer system, the method comprising: acquiring patient data pertaining to the patient, the patient data including data indicative of shape and / or dimensions of the patient's vaginal canal into which the gynecological prosthetic will be disposed; acquiring a digital model of the gynecological prosthetic, the gynecological prosthetic having at least a portion configured to rest on one or more lateral walls of the vaginal canal of the patient; determining a customized digital model of the gynecological prosthetic by adapting the digital model of the gynecological prosthetic using the acquired patient data; and generating a digital file for manufacture of at least a portion of the gynecological prosthetic based on the customized digital model.

Description

[0001] SYSTEMS AND METHODS FOR CUSTOM-DESIGNING A GYNECOLOGICAL PROSTHETIC

[0002] Field of the Disclosure

[0003] [1] The presently disclosed subject matter is directed to the design and development of gynecological prosthetics (also referred to as vaginal devices / pessaries) for the treatment of various women’s pelvic health conditions.

[0004] Background

[0005] [2] Pelvic organ prolapse (POP) is the abnormal descent or herniation of the pelvic organs from their normal attachment sites to or beyond the vaginal walls leading to discomfort in the vagina, leakage of urine and bowel problems. These symptoms can dramatically affect a woman’s quality of life and can have a social, psychological and sexual impact. Pelvic organ prolapse (POP) generally occurs when the normal anatomical support of the pelvic organs in women which is provided by the balanced interaction between pelvic floor muscles and connective tissue attachments is lost or weakened. This is typically due to childbirth, advancing age, obesity and pelvic surgery. It is regarded as a progressive disease, as mild prolapse can eventually lead to advanced stage disease. Women with symptomatic pelvic organ prolapse can be managed expectantly or treated conservatively or surgically.

[0006] [3] Although, POP is likely to have a more diverse dynamic than other health conditions in women, it is treated as a "one-size-fits-all" problem in all cases. First-line treatments for POP include lifestyle and behavioral interventions, pelvic floor muscle training, and vaginal pessaries. The second line of treatment involves surgical intervention (e.g., pelvic reconstruction); however, these interventions may not be pursued as an option, particularly when an individual does not wish to undergo surgery or is an unsuitable candidate. It is estimated that 20% of patients will undergo pelvic floor surgery, which has lifelong risks such as incontinence, infertility, dyspareunia, and a 30% chance of developing another prolapse. Additionally, there have been several reported risks of complications associated with transvaginal mesh implants, which were banned by the United States Food and Drug Administration (FDA) in April 2019.

[0007] [4] Due to these risks, it is imperative to focus on first-line treatments, such as gynecological prosthetics (e.g. pessaries), to facilitate the management of POPs. A conservative option for treating women suffering from POP are vaginal pessaries, which are effective in alleviating symptoms of POP and preventing unnecessary surgeries especially in lower stages of prolapse. Pessaries can be divided into two main categories including support and space-filling pessaries. Support pessaries are preferred for patients as they tend to be easier to remove and insert. Space-filling pessaries are primarily used to support severe POP, especially when the vagina drops after a hysterectomy. As current pessaries are not designed to account for the natural variations within a female's pelvic anatomy, they often displace and do not provide effective symptomatic relief. In fact, pessary fittings have a 30% failure rate; and those that are successfully fitted, report a 50% reported drop rate within the first year, and a 56% complication rate. It is believed that the reason for such a high rate of discontinued use is due to the fact that commercially produced pessaries do not take into consideration anatomic variations of the patient attributed to their general health, genetics, pregnancy experiences, lifestyles, and more. In fact, common pessaries are manufactured in a standard set of sizes and basic geometric / symmetrical shapes which thus limits their efficacy.

[0008] [5] Although pessaries are considered a conservative option, these vaginal devices have some drawbacks, which contribute to discontinuation of use and failure of this treatment. Common complications reported by pessary users, including bleeding and discharge, infection, extrusion, and pain. Moreover, generally two to three pessaries must be fitted per patient in order to maximize comfort, often due to factors such as high BMI and elevated intra-pelvic pressure. Therefore, the pessary tends to slip out of the vagina when these patients walk, perform Valsalva Maneuvers, or void. Other characteristics of women leading to the failure of a vaginal pessary are related to Total Vaginal Length (TVL). When the TVL is short, maintaining the pessary above the levator plate in the middle of the vagina is difficult, causing expulsion or discomfort. Studies have shown that the shape and dimension of the vaginas vary amongst women.

[0009] [6] In addition, the vagina shows dynamic characteristics during various activities and postures. The lower part of the vagina is constrained by muscles, pubic bones, and the perineal body, reducing the variability displacement. However, the upper part of the vagina is relatively burdened less by spatial constraints and causes more shape and location deviations. Moreover, the vaginal canal changes rheological behavior in women with POP overtime. These biochemical changes inside the vagina would consequently change the biomechanical properties of vaginal canal tissues. For instance, prolapsed tissues are stiffer in POP patients compared to non-POP women. The stiffer behavior of tissue would noticeably increase displacement and disorientation of inserted pessaries. Also, there is a correlation between the biomechanical characteristics of the vaginal tissue and parameters like age or parity of patients. These parameters can change the biomechanical behavior of the vaginal tissue over time, causing issues for inserted pessaries like dislocating or falling out. [7] There is a clear unmet need in the market to improve current gynecological prosthetics and prevent surgical intervention. It is an object of the disclosure to improve upon the conventional approaches to address or mitigate some or all of the shortcomings noted above. Therefore, there is a need to develop personalized pessaries that account for the variations in anatomical characteristics between each woman.

[0010] Summary of the Disclosure

[0011] [8] In a first aspect, a method of custom designing a gynecological prosthetic for a patient is provided. The method is configured to be executed by at least one processor of a computer system. The method includes acquiring patient data pertaining to the patient, the patient data including data indicative of shape and / or dimensions of the patient’s vaginal canal into which the gynecological prosthetic will be disposed. The method includes acquiring a digital model of the gynecological prosthetic. The gynecological prosthetic may include at least one portion configured to rest on one or more lateral walls of the vaginal canal of the patient. The method includes determining a customized digital model of the gynecological prosthetic by adapting the digital model of the gynecological prosthetic using the acquired patient data. The method further includes generating a digital file for manufacture of at least a portion of the gynecological prosthetic based on the customized digital model. The acquiring the digital model of the gynecological prosthetic may include retrieving a predetermined digital model of the gynecological prosthetic from a database for future adaptation.

[0012] [9] In another aspect, a non-transitory computer readable medium having recorded thereon instructions that, when executed by a processor of a computing device, configure a processor to implement the methods described herein

[0013]

[0010] In a further aspect, a computing device is provided. The computing device comprises a processor; and a non-transitory computer readable medium having recorded instructions that, when executed by the processor, configure the processor to implement methods as described herein.

[0014]

[0011] 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 the various embodiments of the disclosure. Brief Description of the Drawings

[0015]

[0012] Embodiments will now be described with reference to the attached drawings in which:

[0016] FIGs. 1 A and 1 B are schematics of a vagina in which a gynecological prosthetic has been installed, in accordance with an embodiment of the disclosure;

[0017] FIGs. 2A to 2E are schematics of the gynecological prosthetic of FIGs. 1A and 1 B;

[0018] FIGs. 3A to 3C are schematics of another gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0019] FIGs. 4A to 4D are schematics of another gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0020] FIG. 5 is a block diagram of a gynecological prosthetic customization system having a computing device, in accordance with an embodiment of the disclosure ;

[0021] FIG. 6 is a flowchart of a method of custom-designing a gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0022] FIGs. 7A and 7B are flowcharts of another method of custom-designing a gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0023] FIG. 8 is a schematic of a vaginal canal simulated model and shows where a gynecological prosthetic may rest, in accordance with an embodiment of the disclosure;

[0024] FIGs. 9A and 9B are schematics of a pelvic bony structure including a top view and a bottom view and including measurement parameters, in accordance with an embodiment of the disclosure;

[0025] FIG. 10 is a schematic of the vaginal canal including measurement parameters, in accordance with an embodiment of the disclosure;

[0026] FIG. 11 is a graph of a cervical angle vs. position within the vagina;

[0027] FIG. 12 is a flowchart of an exemplary process for providing a user with a custom therapeutic device, in accordance with an embodiment of the disclosure; FIG. 13 is a schematic of an applicator for installing a gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0028] FIG. 14 is a flowchart of a method of installing a gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0029] FIG. 15 is a functional block diagram of a gynecological prosthetic customization system, in accordance with an embodiment of the disclosure;

[0030] FIG. 16 is a flow chart of a method of gynecological prosthetic customization, in accordance with an embodiment of the disclosure;

[0031] FIGs. 17A to 17D are schematics of another gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0032] FIGs. 18A and 18B are schematics of another gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0033] FIGs. 19A to 19D are schematics of another gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0034] FIGs. 20A to 20D are schematics of another gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0035] FIGs. 21 A to 21 D are schematics of another gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0036] FIGs. 22A to 20C are schematics of another gynecological prosthetic, in accordance with an embodiment of the disclosure;

[0037] FIG. 23 is a schematic of another gynecological prosthetic, in accordance with an embodiment of the disclosure; and

[0038] FIG. 24 is a schematic of another gynecological prosthetic, in accordance with an embodiment of the disclosure.

[0039] Detailed Description of Embodiments

[0040]

[0013] It should be understood at the outset that although illustrative implementations of one or more embodiments of the present disclosure are provided below, the disclosed systems and / or methods may be implemented using any number of techniques. The disclosure should in no way be limited to the illustrative implementations, drawings, and techniques illustrated below, including the exemplary designs and implementations illustrated and described herein, but may be modified within the scope of the appended claims along with their full scope of equivalents.

[0041] Example Gynecological Prosthetics

[0042]

[0014] Referring first to FIGs. 1A and 1 B, shown are schematics of a vagina 100 in which a gynecological prosthetic 200 has been installed, in accordance with an embodiment of the disclosure. The gynecological prosthetic 200 can be installed in the vagina 100 to treat Pelvic Organ Prolapse (POP), by providing support for pelvic organs (not shown) and thereby avoid or mitigate abnormal descent of the pelvic organs beyond vaginal walls. Additionally, or alternatively, the gynecological prosthetic 200 can be installed in the vagina 100 to treat urinary and / or fecal incontinence, or for control of vesicovaginal fistula. The gynecological prosthetic 200 may comprise a vaginal dilator or a stent for post-operative treatment from vaginal reconstruction surgery or for the prevention of vaginal stenosis from post-cancer therapy, or Vaginismus. The gynecological prosthetic 200 may comprise one or more of a sexual wellness device, a contraceptive device or a menstrual device. The gynecological prosthetic 200 may comprise a cerclage pessary for the prevention of pre-term labour for women with cervical incompetence for women. Such gynecological prosthetics 200 may be adapted for women with wider or shorter cervixes than an average size. In some implementations, the gynecological prosthetic 200 is positioned in an upper portion of the vagina 100 and rests on iliococcygeus and pubococcygeus muscles (not shown), which serve as anchor points within the vagina 100. However, other positions within the vagina 100 are possible, such that the gynecological prosthetic 200 can sit anywhere in the vaginal canal, and this may depend on the patient's anatomical characteristics and which pelvic organs are being targeted. Also shown is cervical angle 121 between a vaginal axis 101 and a cervical axis 111.

[0043]

[0015] Referring now to FIGs. 2A to 2E, shown are schematics of the gynecological prosthetic 200 of FIGs. 1A and 1 B. The gynecological prosthetic 200 has a plurality of anchor members 201-204 configured to rest on the anchor points within the vagina 100, and a plurality of connecting links 211 that couple the anchor members 201-204 together. The connecting links 211 are configured to be compressible to enable a compact state when the gynecological prosthetic 200 is being installed in the vagina 100. Also, the connecting links 211 are configured to be expandable from the compact state after the gynecological prosthetic 200 is installed in the vagina 100 so as to push the anchor members 201-204 outward against inside surfaces of the vagina 100 to resist displacement of the gynecological prosthetic 200. The connecting links 211 are designed to provide flexibility and connect the anchor members 201- 204 and prevent them from bending or deformation. The anchor members 201-204 are configured to rest on the anchor points within the vagina 100, and are designed to apply pressure on surrounding muscles and tissues in order to help support the pelvic organs and to hold the whole gynecological prosthetic 200 in place.

[0044]

[0016] In some implementations, the anchor members 201-204 and the connecting links 211 form a base plate 250, and the gynecological prosthetic 200 also has an upper plate 240 coupled to the base plate 250 via a plurality of upper links 212. In some implementations, the upper links 212 can be compressed (or rotated, etc.) to make insertion of the gynecological prosthetic 200 into the vagina 100 possible. In some implementations, the upper plate 240 is to be positioned under the uterus such as a cervix area to hold the uterus and provide support to cervix area. In some implementations, the base plate 250 is designed to provide support to the whole pelvic area and prevent the pelvic organs from descending. The upper links 212 are positioned such that, when a force is applied to the upper plate 240, the upper links 212 redirect at least some of that force to push the anchor members 201-204 of the base plate 250 outward against the inside surfaces of the vagina 100 to further resist displacement of the gynecological prosthetic 200.

[0045]

[0017] Therefore, any downward force that may be applied to the upper plate 240 of the gynecological prosthetic 200 can contribute to the anchor members 201-204 being pushed outward to resist displacement of the gynecological prosthetic 200. The upper plate 240 and its upper links 212 can redistribute pressure toward a white line (tendinous arch), which is a medical term to name the thickening of the parietal fascia of levator ani muscles along the straight line from the pubic arch to the ischial spine bilaterally. The manner in which the anchor members 201-204 are pushed outward will depend on many factors such as the anchor members 201-204, the upper plate 240, the connecting links 211 , the upper links 212, overall geometry of the gynecological prosthetic 200, materials used, and the downward and surrounding pressures such as abdominal pressure or intravaginal pressure in each patient. The upper plate 240 can be positioned at any suitable distance from the base plate 250 and its position and size can vary for each patient.

[0046]

[0018] In some implementations, the upper plate 240 is smaller than the base plate and the upper links 212 connect a periphery of the upper plate to a periphery of the base plate 250. Thus, each upper link 212 is tilted towards the upper plate 240 at an angle 231 , which enables any downward and surrounding force that may be applied to the upper plate 240 of the gynecological prosthetic 200 to contribute to the anchor members 201-204 being pushed outward. Note that force might not only come from above the upper plate 240, but also it may come from the anterior (e.g. bladder) or posterior (e.g. rectum) walls as well as from apical (e.g. uterus), so this might also have an effect not only on the upper plate 240 but also on one of more of the upper links 212. Nonetheless, forces can be redistributed to the lateral walls. The angle 231 can be different for each upper link 212 and can for example include any suitable value in a range between a = 0° to 90°.

[0047]

[0019] In some implementations, the anchor members 201-204 include an anterior member 201 configured to rest on an anterior wall of the vagina 100, a posterior member 202 configured to rest on a posterior wall of the vagina 100, and side members 203 and 204 configured to rest on lateral walls of the vagina 100. The anterior and posterior members 201 and 202 can provide outward force against the anterior and posterior walls of the vagina 100. Meanwhile, the side members 203 and 204 can provide outward force against the side walls of the vagina 100. The amount of force for each anchor member 201-204 can be designed by geometry, material and force of the gynecological prosthetic 200, for example via the angle 231 of each Iink 212. The anchor members 201-204 can thus distribute pressure among the anterior, posterior and lateral walls of the vagina 100. Although four anchor members 201-204 are shown, it is noted that other implementations are possible in which more or fewer anchor members are present. Such anchor members can distribute pressure among the lateral walls of the vagina via side members, and among the anterior and / or posterior walls of the vagina depending on whether anterior and posterior members are present.

[0048]

[0020] In some implementations, the upper plate 240 is tilted by an angle 230 relative to the base plate 250, such that the upper plate 240 and the base plate 250 are not parallel to one another. This tilt can be designed based on geometry and / or characteristics of the vagina 100, such that the upper plate 240 is suitably positioned to transfer any downward or surrounding force to the anchor members 201-204. In some implementations, the angle 230 corresponds to the cervical angle 121 between the cervical axis 111 and the vaginal axis 101. The angle 230 can for example be between 9 = 0° to 80°, with an anterior portion of the upper plate 240 being lowered towards the base plate 250. However, for abnormal situations in which the uterus is positioned in the opposite direction towhat is shown in FIG. 1 A, the upper plate 240 can be designed with a tilt in the opposite direction to what is shown in FIG. 2B, such that the angle 230 is between 9 = -80° to 0°, with the anterior portion of the upper plate 240 being raised away from the base plate 250. In other implementations, the upper plate 240 is parallel to the base plate 250, such that the angle 230 is 9 = 0°. More generally, the angle 230 can be designed between 9 = -80° to 80°, depending the geometry and / or characteristics of the vagina 100 and positioning of the uterus.

[0049]

[0021] The gynecological prosthetic 200 has a design that is based on and / or fitted to the anatomical shape of the upper vagina. The gynecological prosthetic 200 can have a better fit to the anatomical shape of the vagina 100 compared to current gynecological prosthetics, in part because its design and flexibility enable it to expand in certain directions and rest on the anchor points in the vaginal canal, for example anterior, posterior and side directions. It is possible to balance pressure applied to the anterior, posterior and side walls. This is an improvement over conventional gynecological prosthetics that may focus pressure on only anterior and posterior walls and are not expandable.

[0050]

[0022] In particular, the gynecological prosthetic 200 implements an expansion mechanism toward specific resting / anchor points to resist displacement, a pressure redistribution mechanism to redirect the pressure from the anterior and posterior walls of the vaginal canal to the lateral walls of the vaginal canal, and a certain angle 230 in the design adapted to the cervical angle formed by the cervical axis and the anterior wall of the vagina. This is an improvement over some conventional gynecological prosthetics that lack such features.

[0051]

[0023] In some implementations, the anchor members 201-204 differ from the connecting links 211 in terms of thickness and / or material. For example, in some implementations, the anchor members 201-204 are formed of a first material and the connecting links 211 are formed of a second material, such that the first material is more rigid than the second material. That being said, it is noted that the second material can be the same as the first material in nature but with different flexibility. The first material is selected such that the anchor members 201-204 are rigid enough to engage with the inside surfaces of the vagina 100. The second material is selected such that the connecting links 211 are compressible to enable the compact state when the gynecological prosthetic 200 is being installed in the vagina 100, and expandable from the compact state after the gynecological prosthetic 200 is installed in the vagina 100. More generally, the gynecological prosthetic 200 can be formed of one or more materials, including but not limited to various types of elastomers such as medical-grade silicone, flexible plastics such as Agilus 30, hard plastic, steel, metal alloys and biocompatible materials such as silicone, etc. In some implementations, the anchor members 201-204 are thicker than the connecting links 211 . Other implementations are possible.

[0052]

[0024] In some implementations, the gynecological prosthetic 200 has a silicone layer coating. The silicone layer coating can cover all surfaces of the gynecological prosthetic 200. In other implementations, there is no silicone layer coating. In some implementations, there is no silicone layer coating when the gynecological prosthetic 200 is directly 3D printed using silicone. In some implementations, the gynecological prosthetic 200 has a biocompatible coating other than silicone. In some implementations, the gynecological prosthetic 200 is coated with one or multiple coatings including but not limited to anti-fungus / anti-infection drugs, hormones and ph-balancers, to prevent balance the vaginal acidity and prevent odor-causing bacteria, infections and / or extreme discharge, and / or pigments for aesthetic purposes because silicone is normally clear. In some implementations, the gynecological prosthetic 200 is coated with hormonal drugs to help decrease failure rate of the gynecological prosthetic 200 or can be used as a contraceptive method, letting patients have simultaneous therapies (i.e. hormonal therapy along with prosthetic therapy). Other coatings are possible. In other implementations, there is no such coating.

[0053]

[0025] In some implementations, the connecting links 211 and the anchor members 201-204 are connected in series around a periphery of the gynecological prosthetic 200, and the gynecological prosthetic 200 has a structural mesh 270 connecting the anchor members 201-204 to mitigate deformation of the gynecological prosthetic 200 when installed in the vagina. In other implementations, there is no such structural mesh 270.

[0054]

[0026] In some implementations, the base plate 250 and the upper plate 240 enable a vaginal discharge to pass through the gynecological prosthetic 200. For example, in some implementations, the upper plate 240 is a torus shape through which a vaginal discharge can pass through. Also, in some implementations, the structural mesh 270 of the base plate 250 has holes to enable a vaginal discharge to pass through. Other implementations are possible for allowing a vaginal discharge to pass through the gynecological prosthetic 200. By enabling a vaginal discharge to pass through the gynecological prosthetic 200, the gynecological prosthetic 200 can be used during menstruation. However, alternative implementations are possible in which the gynecological prosthetic 200 does not enable a vaginal discharge to pass through, such that the gynecological prosthetic 200 might be removed for any menstruation.

[0055]

[0027] In some implementations, the gynecological prosthetic 200 has a removing feature (not shown), for example a knob or a string attached to the gynecological prosthetic 200 to collapse and withdraw the gynecological prosthetic 200 compactly at some later time. Other removing features are possible and are within the scope of the disclosure. In some implementations, the gynecological prosthetic 200 is disposable. In some implementations, the gynecological prosthetic 200 is biodegradable when using a material as a wrap for the gynecological prosthetic 200 after its usage that corrupts plastic / silicone and turns the gynecological prosthetic 200 into compost. In other implementations, the gynecological prosthetic 200 is not disposable and can be re-used, for example up to two years or some other suitable time-frame. In some implementations, the gynecological prosthetic 200 is multi-use and can be repeatedly removed and reinserted for up to 29 days or more for example.

[0056]

[0028] It is to be understood that the gynecological prosthetic 200 of FIGs. 2A to 2E is shown with very specific features for exemplary purposes only. Other gynecological prosthetics are possible and are within the scope of the disclosure.

[0029] With reference to FIGs. 3A to 3C, FIGs. 4A to 4D, FIGs. 17A to 17D, FIGs. 18A to 18D, FIGs. 19A to 19D, FIGs. 20A to 20D, FIGs. 21 A to 21 D, FIGs. 22A to 22C, FIG. 23 and FIG, 24, other example gynecological prosthetics 300, 400, 1700, 1800, 1900, 2000, 2100, 2200, 2300 and 2400, respectively, are described below.

[0057]

[0030] The gynecological prosthetics 300, 400, 1700, 1800, 1900, 2000, 2100, 2200, 2300 and 2400 are examples of prosthetic designs that can be customized to a patient according to embodiments of the present technology. These gynecological prosthetics may be used to manage one or more of uterine prolapse, urinary incontinence symptoms, rectocele (displacement of rectum), and cystocele (displacement of bladder), to name a few. Customization and manufacture of other gynecological prosthetics are within the scope of the present technology.

[0058]

[0031] These gynecological prosthetics 300, 400, 1700, 1800, 1900, 2000, 2100, 2200, 2300 and 2400 have a dynamic structure where they expand differently and in different directions based on each patient's anatomy and the direction and the place where the pressure is being applied. They are designed to change configuration responsive to pressure in order to remain in situ, stay comfortable, stay safe, etc. The pressure may come from various activities of the patient such as sneezing, coughing, exercising, laughing, defecating, etc. In some embodiments, the gynecological prosthetic is configured to direct a force from a top portion to a bottom portion to cause an increase in a spread of the gynecological prosthetic. The gynecological prosthetics 300, 400, 1700, 1800, 1900, 2000, 2100, 2200, 2300 and 2400 have at least portion configured to support a lateral vaginal wall.

[0059]

[0032] Referring first to FIGs. 3A to 3C, the gynecological prosthetic 300 of FIGs. 3A to 3C has a plurality of anchor members 301-303 configured to rest on anchor points within a vagina, and a plurality of connecting links 311 that couple the anchor members 301-303 together. Also, the gynecological prosthetic 300 has an upper plate 340 coupled to a base plate 350 via upper links 312, such that angles 330 and 331 are formed. The gynecological prosthetic 300 is similar to what has already been described above for the gynecological prosthetic 200 of FIGs. 2A to 2E and thus much of the description is not repeated here.

[0060]

[0033] However, there are notable differences between the gynecological prosthetic 300 of FIGs. 3A to 3C and the gynecological prosthetic 200 of FIGs. 2A to 2E. For example, the gynecological prosthetic 300 of FIGs. 3A to 3C has only three anchor members 301-303, and the anchor members 301-303 and the connecting links 311 do not span an entire periphery of the gynecological prosthetic 300. This is because the anchor members 301-303 of the gynecological prosthetic 300 do not include a posterior member. As such, the gynecological prosthetic 300 is designed to avoid or mitigate force applied to the posterior wall of the vagina 100, and to instead apply force to the anterior and side walls of the vagina 100. In another embodiment, there is no anterior member, such that forces are not distributed to the anterior wall of the vagina 100. The gynecological prosthetic 300 of FIGs. 3A to 3C also does not have a structural mesh, although in other implementations it can be equipped with one.

[0061]

[0034] Referring now to FIGs. 4A to 4D, the gynecological prosthetic 400 of FIGs. 4A to 4D has a plurality of anchor members 401-404 configured to rest on anchor points within a vagina, and a plurality of connecting links 411 that couple the anchor members 401-404 together. Also, the gynecological prosthetic 400 has an upper plate 440 coupled to a base plate 450 via upper links 412, such that angles 430 and 431 are formed. The gynecological prosthetic 400 is similar to what has already been described above for the gynecological prosthetic 200 of FIGs. 2A to 2E and thus much of the description is not repeated here.

[0062]

[0035] However, there are notable differences between the gynecological prosthetic 400 of FIGs. 4A to 4D and the gynecological prosthetic 200 of FIGs. 2A to 2E. For example, some of the anchor members 401-404 have a concave shape. In particular, the anchor members 401-404 include anterior and posterior members 401 and 402 which are concaved, such that the connecting links 411 may protrude outward to some extent. These connecting links 411 nonetheless operate in a similar manner as the connecting links 211 of the gynecological prosthetic 200 of FIGs. 2A to 2E. The anterior member 401 along with adjacent links 411 create a contour 405 which may provide a better fit against the anterior wall of the vagina 100. Similarly, the posterior member 402 along with adjacent links 411 may provide a better fit against the posterior wall of the vagina 100. The concave shape can mimic the vaginal canal’s shape as much as possible and prevent the gynecological prosthetic 400 from blocking the urethra in the anterior part and the rectum in the posterior part. The gynecological prosthetic 400 of FIGs. 4A to 4D also does not have a structural mesh, although in other implementations it can be equipped with one.

[0063]

[0036] After conducting research and development on pelvic floor characteristics, the gynecological prosthetics 200, 300 and 400 disclosed herein have been designed with all relevant information of the pelvic floor and muscles in mind.

[0064]

[0037] In another embodiment, there is provided a gynecological prosthetic configured to rest on anchor points within a vaginal canal. The gynecological prosthetic need not resemble the gynecological prosthetics 200, 300 and 400 depicted and described above. In some implementations, the gynecological prosthetic has geometry and / or materials designed based on a cervical angle.

[0038] FIGs. 17A to 17D depict a gynecological prosthetic (pessary) 1700 viewable from various angles. The pessary offers targeted support at three levels to address Pelvic Organ Prolapse (POP) and related conditions. It can also assist with urinary and fecal incontinence, rectocele, and cystocele. The pessary's positioning in the upper vaginal region is based on the patient's anatomy and the specific pelvic organs being addressed. The cervical angle, which can vary from -180 to 180 degrees, influences its placement and angles as shown in A1 to A4.

[0065]

[0039] This pessary design incorporates unique features to provide dynamic support when experiencing pressure variations, like during a Valsalva maneuver, laughing, contractions, coughing, sneezing, exercising, etc. Anchors at the front and back (1 and 6 in FIG. 17A) exert dynamic pressure on the vaginal walls. These anchors have sizes and curvature that are customized for rectocele, cystocele, or other conditions. Curvature 5 evenly distributes pressure. The pessary's narrower central part (FIG 17A.2) allows expansion from sides (4 and 5) when pressure is applied from the front or back. Expansion is controlled by angles A1 to A4 (ranging from 0 to 180 degrees), and legs 4 and 5 can expand from 1 mm to 20 cm through design parameter adjustments. Varying A1 and A2 influences the degree of leg expansion, concentrating material in the central part. A4's angle between legs affects the sample's size, with a smaller angle bringing the legs closer and increasing height. All surfaces (7) are curved for comfort and fit. Shifting angle A3 affects pressure distribution on the vaginal walls, essential for various prolapse types.

[0066]

[0040] The gynecological prosthetic features multiple anchor members (legs) in FIG. 17A.5, designed to rest on vaginal anchor points and expand from a compact state after installation to resist displacement. These parts withstand pressure from organs above, expanding toward surrounding muscles and tissues to support pelvic organs and hold the prosthetic in place. In certain implementations, curved legs (FIG. 17A.5) distribute pressure evenly on the vaginal wall. The legs can be compressed for easier insertion. The upper plate 3 can be positioned beneath the uterus or cervix to offer support similar to the first level. Angles A3 and A4 enable dynamic expansion, particularly under excessive pressure conditions like coughing. The leg placement directs force applied to the upper surface towards pushing the legs against the vaginal walls to prevent displacement. The legs can redistribute pressure towards a tendinous arch (level 2 support), a term denoting the thickening of the parietal fascia of levator ani muscles along the pubic arch to the ischial spine bilaterally.

[0067]

[0041] FIGs. 18A-18E present a two-level pessary with multiple components: a connector of bottom curve (a.1), connecting links in the sides (a.2), a top level (b.3), connecting links in the back (rear) (b.4), a channel for rods (c.5), channels in the links (d.6), and a bottom level (e.7). It is worth noting that this configuration serves as an example and can be customized. Components such as the connector of the bottom curve, connecting links, top level, rear connecting links, channel for rods, link channels, and the bottom level can all be modified as needed.

[0068]

[0042] In FIGs. 18A-18D, a two-level pessary is designed to support the uterus. The angle adjustment between the top and bottom levels (0 to 80 degrees) allows the uterus to rest on the top level as desired. By employing connecting links (1 to 20 mm thickness), pressure from the upper level is transferred to the lower level, expanding the pessary (adjustable from 0 to 100% of initial dimensions). The curvature of the lower level is customizable to fit each patient's unique anatomy. The diameter can vary (1 cm to 20 cm) based on individual conditions.

[0069]

[0043] The functionality of the pessary can be influenced by the choice of material. For instance, stiffer materials can be used for the connecting links to enhance force transmission and side expansion. This can be achieved through various methods, such as 3D printing with different materials for the links, inserting stiff rods into channels within the links, or integrating stiff rods into the molding process. Materials like plastics, springs, metal, and hard resins can be used for these rods.

[0070]

[0044] Two-level pessary designs can also feature a membrane to support the bladder or rectum. The membrane's design can vary based on the patient's clinical condition, covering different portions between links on the front and back sides. The membrane can be made of biocompatible materials and have a thickness ranging from 1 to 10 mm.

[0071]

[0045] Additionally, the expansion amount can be adjusted by modifying the front and back of the bottom level, either by disconnecting them or connecting them through various means like a connecting shaft, curve shape, triangle shape, thread, spring, or lattice structure. These adjustments can result in expansions ranging from 5 mm to 150 mm.

[0072]

[0046] FIGs. 19A-19D and 20A-20D present an alternative two-level pessary 1900, 2000. In FIGs. 19A-19D, a flexible structure is introduced at the pessary's bottom. This flexible structure, which may incorporate a partial or full spring with a lattice structure, enables easier expansion and quicker return to the initial resting position. While plastic is a suggested material for the spring, other materials are also suitable. This feature allows the pessary to adapt its shape when subjected to excessive force, such as during coughing. In FIG. 20A-20D, a knob is incorporated into the pessary 2000. The knob enhances the pressure applied to the urethra, offering potential relief to patients with urinary incontinence.

[0047] Example pessary 2100 in FIGs. 21A-21 D comprises a U-shaped frame with arms having free ends. The arms are connected by a belt portion. The pessary 2100 has a dynamic design in that pressure applied downwardly to the pessary would cause the free ends of the arms to move laterally relative to each other.

[0073]

[0048] Example pessary 2200 in FIGs. 22A-22C comprises an inflatable body having a first portion housed within a sleeve and having a restricted movement and a second portion which is not restricted by the sleeve. Like the other example pessary designs described herein, pessary 2200 is dynamic in that pressure applied to one part of the pessary can cause movement or expansion of another part of the pessary.

[0074]

[0049] Example pessary 2300 in FIG. 23 comprises a pessary configured to take measurements from within the vaginal canal. Pessary 2300 has at least one sensor disposed on a body.

[0075]

[0050] Example pessary 2400 in FIG. 24 comprises a pessary which is donut shaped and inflatable.

[0076]

[0051] The customization of pessaries with a myriad of design parameters, as is evident by the various pessary designs described above with reference to FIGS. 1 to 4 and 17 to 24, necessitates a sophisticated solution to navigate the large, multivariate design space. These diverse design elements serve as the building blocks for tailoring pessaries to individual patient needs, reflecting the intricate, and patient specific, nature of pelvic organ prolapse and other gynecological conditions.

[0077]

[0052] Within this expansive design space, two-level designs, expandability, spreadability, and specific anchor locations are useful tools for addressing a wide spectrum of anatomical variations and clinical scenarios. However, there is significant complexity of these design parameters that requires an advanced customization approach.

[0078]

[0053] The systems and methods described herein, feature simulation and machine learning (ML) models in order to arrive at a patient customized, high performing gynecological prosthetic. The simulation provides insights into the interplay between the design parameters and their impact on patient-specific outcomes. Through an iterative process (in some embodiments), the customization systems and methods described herein explore many combinations to fine-tune the pessary design.

[0054] The ML model, part of an optimization stage, harnesses the data from simulations, refining the design parameters based on predefined performance indicators. It navigates this multifaceted design space with efficiency, to converge on an optimized solution.

[0079]

[0055] As will be described further below, the customization systems and methods described herein allow dimensions and geometry of the pessary to be customized to fit the patient's specific anatomy, such as width, height, and perimeter of the vaginal canal. The overall shape of the pessary may be customized by the ML model, including its curvature and contours. Additional optimization parameters include any of the following. The location of anchor points or legs on the pessary can be tailored to provide support where needed and avoid discomfort. Two-level designs can be customized to provide different levels (relative heights) of support to address specific anatomical conditions, such as uterine prolapse. The choice of materials used in the pessary design can be customized for optimal flexibility, stiffness, or force transmission. Some pessary designs incorporate flexible elements or springs to adapt to changing pressure and provide a dynamic response and the degree of flexibility can be adjusted. The ability to adjust the pessary's expansion under certain loads can be adapted to accommodate various levels of abdominal and intravaginal pressure. Additional features, such as membranes, can be added to support the bladder or rectum and can be customized in design and material as a further design parameter for optimization. The configuration of criss-cross / zig-zag elements or connecting links can be customized to control pressure distribution. Supplementary features like knobs can be added to provide specific support for conditions like urinary incontinence.

[0080]

[0056] In some implementations, the geometry and / or materials of the gynecological prosthetic are designed based on at least some of the following parameters:

[0081] • abdominal pressure;

[0082] • intra-vaginal pressure;

[0083] • pressure from pelvic floor muscles (PFM);

[0084] • atmospheric pressure (AP);

[0085] • pressure from bladder towards vaginal canal;

[0086] • pressure from rectum towards vaginal canal;

[0087] • intra-abdominal pressure including both transvaginal and transrectal pressure;

[0088] • intravesical pressure;

[0089] • intra-abdominal pressure including transvaginal pressure;

[0090] • distance between ischial spines;

[0091] • distance between ischial spines and coccyx;

[0092] • distance between ischial spines and pubic symphysis;

[0093] • anterior fornix distance; • posterior fornix distance;

[0094] • cervical size; and

[0095] • cervical angle.

[0096] Method for Custom-Designing a Gynecological prosthetic

[0097]

[0057] It is to be understood that the vagina 100 as depicted in FIGs. 1A and 1 B is merely exemplary and that varying shapes and sizes are not only possible but are expected among a population of women based on genetics, ethnicity, parity, age, Body Mass Index (BMI), and other factors. A woman’s vagina is generally unique in terms of exact shape and size. As such, it is generally advantageous to custom-design a gynecological prosthetic for a woman’s vagina so that the gynecological prosthetic may suitably fit. A gynecological prosthetic can be customized in terms of shape and / or size according to a specific patient.

[0098]

[0058] Referring now to FIG. 5, shown is a block diagram of a gynecological prosthetic customization system 500 having a computing device 510. The computing device 510 is cloudbased and has gynecological prosthetic customization circuitry 514. In some implementations, the computing device 510 also has a user interface 511 for interacting with a user, and / or a network adapter 512 for communicating with client computing devices 531-534 over a network 502. The computing device 510 can have additional components, but these are not shown for simplicity. The client computing devices 531-534 can for example include a desktop computer 531 , a tablet computer 532, a smartphone 533, a laptop 534, and / or any other appropriate client computing devices.

[0099]

[0059] The gynecological prosthetic customization circuitry 514 of the computing device 510 operates to customize a gynecological prosthetic. Such operation will be described below with reference to FIG. 6, which is a flowchart of a method of custom-designing a gynecological prosthetic. Although the method of FIG. 6 is described below with reference to the computing device 510 in the gynecological prosthetic customization system 500 shown in FIG. 5, it is to be understood that the method of FIG. 6 is applicable to other systems. In general, the method of FIG. 6 is applicable to the computing device 510 in any appropriately configured system.

[0100]

[0060] At step 601 , the computing device 510 acquires patient data pertaining to a subject, for example from the user interface 511 and / or one or more of the client computing devices 531-534. A patient’s vaginal canal can be measured by a physician using manual measurements, for example by using a POP-Q interactive assessment tool. In some embodiments, measurements of the patient’s vaginal canal may be obtained using measurement devices and methods described in WO2024 / 113063 published on 6 June 2024, the contents of which are herein incorporated in their entirety. The computing device 510 can receive these measurements, BMI values, and additional patient-specific metrics.

[0101]

[0061] At step 602, the computing device 510 selects a type of gynecological prosthetic out of a plurality of types of pre-defined gynecological prosthetics. Each pre-defined gynecological prosthetic has been designed using pre-clinical data and is configured to expand differently and in different directions based on received pressure from surrounding tissues and organs. The pre-defined gynecological prosthetics can for example include any one or more of the gynecological prosthetics 200, 300, 400, 1700, 1800, 1900, 2000, 2100, 2200, 2300 or 2400, and / or other gynecological prosthetics. The computing device 510 can select which one of these predefined gynecological prosthetics would be most suitable, based on the patient data.

[0102]

[0062] At step 603, the computing device 510 calculates geometry and / or material of the gynecological prosthetic based on the patient data that has been acquired. In this way, the gynecological prosthetic can be customized based on characteristics of the subject, such as a size of the upper vagina for example, and the gynecological prosthetic can be tailored specifically to the subject’s anatomy and body habitus. In doing so, the gynecological prosthetic isn’t necessarily designed from scratch, because it is based on the pre-defined gynecological prosthetic that has been selected. The patient data can be fitted onto findings and predetermined gynecological prosthetic geometry and materials.

[0103]

[0063] In some implementations, the computing device 510 maintains pre-clinical data, such that the selecting and the calculating steps are based on both the pre-clinical data and the patient data. The pre-clinical data can for example include existing CT scans, MRI images, ultrasound scans, and other existing patient data / information that could influence the geometry of the design.

[0104]

[0064] In some implementations, the computing device 510 generates a vaginal canal model based on the patient data, and simulates the gynecological prosthetic in the vaginal canal model to evaluate suitability of the gynecological prosthetic in accordance with a target function. The target function is a mathematical function that is used to calculate suitability based on a defined criteria. The defined criteria can for example include reducing size of the gynecological prosthetic while simultaneously enabling enough outward forces by parts of the gynecological prosthetic, such as the anchor members, to avoid the gynecological prosthetic from being dislodged and while reducing a maximum force on any one surface. Other defined criteria are possible. The computing device 510 can calculate the geometry and / or material of the gynecological prosthetic in a manner that adjusts the geometry and / or material of the gynecological prosthetic to enhance the suitability of the gynecological prosthetic based on the target function. An Artificial Neural Network (ANN) or other Machine Learning (ML) method can be employed in this regard. ANN and ML methods can be used to find solutions by tweaking variables in such a way that reduces or increases a target function until convergence at a solution.

[0105]

[0065] An automated finite element analysis (FEA) study has been developed. During an automated FEA study, called parametric study, simulation software (Finite Element Analysis Software and topology optimization) can be coupled with ML algorithms such as ANN algorithms to find a suitable performing and topologically suitable design. The customized design is based on the patient’s anatomy and is capable of distributing the forces and stresses in the direction of supporting vaginal tissues. Topology optimization can be performed to reduce weight of the gynecological prosthetic without compromising functionality. In some implementations, calculation of material is part of the topology optimization in which how much material is used can be designed, but the material itself may be the same for everyone. However, the material can be designed in other implementations depending on ability to directly 3D print biocompatible silicone.

[0106]

[0066] There are many possibilities for the gynecological prosthetic customisation circuitry 514 of the computing device 510. In some implementations, the gynecological prosthetic customisation circuitry 514 includes a processor 516 that executes software, which can stem from a computer readable medium 518. In some implementations, the computer readable medium 518 also has a database 520 for storing data as described herein. However, other implementations, besides software implementations, are possible and are within the scope of this disclosure. It is noted that other implementations can include additional or alternative hardware components, such as any appropriately configured FPGA (Field- Programmable Gate Array), ASIC (Application-Specific Integrated Circuit), and / or microcontroller, for example. More generally, the gynecological prosthetic customisation circuitry 514 of the computing device 510 can be implemented with any suitable combination of hardware, software and / or firmware.

[0107]

[0067] According to another embodiment of the disclosure, there is provided a non- transitory computer readable medium having recorded thereon statements and instructions that, when executed by the processor 516 of the computing device 510, implement a method as described herein. The non-transitory computer readable medium can be the computer readable medium 518 of the computing device 510 shown in FIG. 5, or some other non-transitory computer readable medium. The non-transitory computer readable medium can for example include an SSD (Solid State Drive), a hard disk drive, a CD (Compact Disc), a DVD (Digital Video Disc), a BD (Blu-ray Disc), a memory stick, or any appropriate combination thereof.

[0068] In the context of the present specification, unless expressly provided otherwise, the expression “computer-readable medium” and “memory” are intended to include media of any nature and kind whatsoever, non-limiting examples of which include RAM, ROM, disks (CD- ROMs, DVDs, floppy disks, hard disk drives, etc.), USB keys, flash memory cards, solid statedrives, and tape drives.

[0108]

[0069] In the context of the present specification, a “database” is any structured collection of data, irrespective of its particular structure, the database management software, or the computer hardware on which the data is stored, implemented or otherwise rendered available for use. A database may reside on the same hardware as the process that stores or makes use of the information stored in the database or it may reside on separate hardware, such as a dedicated server or plurality of servers.

[0109]

[0070] The computing device 510 of FIG. 5 may be used to implement and / or execute any of the methods described herein. In some embodiments, the computing device 510 may be implemented by any of a conventional personal computer, a network device and / or an electronic device (such as, but not limited to, a mobile device, a tablet device, a server, a controller unit, a control device, etc.), and / or any combination thereof appropriate to the relevant task at hand. In some embodiments, the computing device 510 comprises various hardware components including one or more single or multi-core processors collectively represented by processor 516, a solid-state drive (represented by computer readable medium 518), a random access memory (represented by computer readable medium 518), and an input / output interface. The computing device 510 may be a computer specifically designed to operate a machine learning algorithm (MLA) to perform the machine learning aspects of the present disclosure. The computing device 510 may be a generic computer system.

[0110]

[0071] The computing device 510 may also be a subsystem of one of the above-listed systems. In some other embodiments, the computing environment 510 may be an “off-the-shelf’ generic computer system. In some embodiments, the computing device 510 may also be distributed amongst multiple systems. The computing device 510 may also be specifically dedicated to the implementation of the present technology. As a person in the art of the present technology may appreciate, multiple variations as to how the computing device 510 is implemented may be envisioned without departing from the scope of the present technology.

[0111]

[0072] Those skilled in the art will appreciate that the processor 516 is generally representative of a processing capability. In some embodiments, in place of or in addition to one or more conventional Central Processing Units (CPUs), one or more specialized processing cores may be provided. For example, one or more Graphic Processing Units (GPUs), Tensor Processing Units (TPUs), and / or other so-called accelerated processors (or processing accelerators) may be provided in addition to or in place of one or more CPUs.

[0112]

[0073] The computer readable medium 518 may provide system memory will typically include random access memory, but is more generally intended to encompass any type of non- transitory system memory such as static random access memory (SRAM), dynamic random access memory (DRAM), synchronous DRAM (SDRAM), read-only memory (ROM), or a combination thereof. The computer readable medium 518 may include a solid-state drive as an example of a mass storage device, but more generally such mass storage may comprise any type of non-transitory storage device configured to store data, programs, and other information, and to make the data, programs, and other information accessible via a system bus. For example, mass storage may comprise one or more of a solid state drive, hard disk drive, a magnetic disk drive, and / or an optical disk drive.

[0113]

[0074] Communication between the various components of the computing device 510 may be enabled by a system bus comprising one or more internal and / or external buses (e.g., a PCI bus, universal serial bus, IEEE 1394 “Firewire” bus, SCSI bus, Serial-ATA bus, ARINC bus, etc.), to which the various hardware components are electronically coupled.

[0114]

[0075] The input / output interface (not shown) may allow enabling networking capabilities such as wired or wireless access. As an example, the input / output interface may comprise a networking interface such as, but not limited to, a network port, a network socket, a network interface controller and the like. Multiple examples of how the networking interface may be implemented will become apparent to the person skilled in the art of the present technology. For example, the networking interface may implement specific physical layer and data link layer standards such as Ethernet, Fibre Channel, Wi-Fi, Token Ring or Serial communication protocols. The specific physical layer and the data link layer may provide a base for a full network protocol stack, allowing communication among small groups of computers on the same local area network (LAN) and large-scale network communications through routable protocols, such as Internet Protocol (IP).

[0115]

[0076] The input / output interface may be coupled to a touchscreen or other display screen of the exemplary client devices of desktop 531 , tablet 532, smartphone 533 and laptop 534 and / or to the one or more internal and / or external buses. The display screen may be part of the display. In some embodiments, the touchscreen is a display. In some embodiments, the input / output interface may be connected to a keyboard (not shown), a mouse (not shown) or a trackpad (not shown) allowing the user to interact with the computing device 510 or any of the connected devices of desktop 531 , tablet 532, smartphone 533 and laptop 534.

[0077] According to some implementations of the present technology, the computer readable medium 518, e.g. a solid-state drive stores program instructions suitable for being loaded into the random access memory of the computer readable medium 518 and executed by the processor 516 for executing acts of one or more methods described herein. For example, at least some of the program instructions may be part of a library or an application.

[0116]

[0078] Referring now to FIGs. 7A and 7B, there is shown is a flowchart of another method of custom-designing a gynecological prosthetic. Although the method of FIGs. 7A and 7B is described below with reference to the computing device 510 in the gynecological prosthetic customization system 500 shown in FIG. 5, it is to be understood that the method of FIGs. 7A and 7B is applicable to other systems. In general, the method of FIGs. 7A and 7B is applicable to the computing device 510 in any appropriately configured system.

[0117]

[0079] At step 701 , the computing device 510 acquires patient data pertaining to a subject, for example from the user interface 511 and / or one or more of the client computing devices 531-534. The patient data can include BMI, cervical size, measurements from POP-Q, whether uterus is inverted, and measurements from a measuring tape or a Caliper. However, additional and / or alternative patient data is possible. In some embodiments, measurements of the patient’s vaginal canal may be obtained using measurement devices and methods described in WO2024 / 113063 published on 6 June 2024, the contents of which are herein incorporated in their entirety.

[0118]

[0080] At step 702, the computing device 510 executes software to process the patient data. The software can perform various processes at step 703, such as translating BMI to intravaginal pressure, applying measurements to a vaginal canal simulated model, changing a gynecological prosthetic size according to the measurements and the distance of the ischial spines to each other and to the pubis and coccyx, and creating a diamond shape and calculating a desired reaction force and its direction. However, additional and / or alternative processes are possible.

[0119]

[0081] Regarding steps 702 and 703, FIG. 8 is a schematic of the vaginal canal simulated model and show where a gynecological prosthetic may rest. Also, FIGs. 9A and 9B are schematics of a pelvic bony structure including a top view (FIG. 9A) and a bottom view (FIG. 9B). Distances between ischial spines, coccyx and pubic symphysis are shown. These distances can be determined and used in calculating the diamond shape (or two triangles) and the desired reaction force and its direction. The vertices of the diamond shape include the ischial spines, pubic and coccyx. This creates a boundary of a 3D modeling space. The diamonds’ sides (including but not limited to one or a combination of multiple sides) can be where the gynecological prosthetics side sections can rest on. In some implementations, there is provided image recognition to recognize the ischial spines.

[0120]

[0082] Referring back to FIG. 7, at step 704, the computing device 510 places a gynecological prosthetic inside the vaginal canal simulated model, and simulation iterations are started. The outputs of the model can include but are not limited to: displacements, reaction forces, total deformations, stress distribution, etc. The iterations can include steps 705 to 708, which can involve topology optimization and parametric study (step 705) as described above, simulation iteration results (step 706), machine learning to evaluate and modify the gynecological prosthetic based on the simulation iteration results (step 707), and calculating output parameters based on the machine learning (step 708).

[0121]

[0083] After completion of the iterations, for example upon steady-state convergence of the output parameters, the output parameters for the gynecological prosthetic should result in a gynecological prosthetic that should suitably fit the subject. The gynecological prosthetic can then be manufactured, for example using 3D printing or by other manufacturing means. The gynecological prosthetic can be directly 3D printed, or a mold of its shape can be 3D printed and optionally coated. In some implementations, the gynecological prosthetic is manufactured using a medical-grade silicone and / or a biocompatible one or combination of multiple materials or to be molded and / or cast with the mentioned materials.

[0122]

[0084] In some implementations, the gynecological prosthetic is 3D printed using PolyJet technology to combine at least two polymers in the gynecological prosthetic, and then the gynecological prosthetic is coated with a medical grade silicone or any other silicone based material. PolyJet technology is a 3D printing technology that can produce smooth, accurate parts, prototypes and tooling. With microscopic layer resolution and high accuracy, it can produce thin walls and complex geometries using a wide range of materials. In some implementations, the at least two polymers includes Agilus30 and Vero, which can be used to create flexible rubbers with varying and designed flexibility. Other polymers are possible. Note that this manufacturing method can be used to manufacture other gynecological prosthetics besides the gynecological prosthetics 200, 300 and 400 that have been depicted and described herein. More generally, the manufacturing method can be used to manufacture any suitable gynecological prosthetic.

[0123]

[0085] After the gynecological prosthetic is manufactured, it can be sent to a clinician for validation. In some implementations, for ongoing management, a digital health platform can be provided by the computing device 510 so that clinicians can manage the patients' treatment plans etc. The clinicians can access the digital health platform through the client computing devices 531-534. The digital health platform can be implemented using cloud software on the computing device 510 to show treatment plans online and support digital health management.

[0124]

[0086] This method can enable an intravaginal customized gynecological prosthetic to treat feminine pelvic organ prolapse and urinary / fecal incontinence, amongst other clinical needs. Clinicians can obtain patient-specific measurements of the vaginal canal (through any available method they use). They can input the measurements into the computing device 510. These measurements can be fit to the vaginal canal model and the design of the gynecological prosthetic will adapt to this vaginal canal’s anatomical characteristics as described above.

[0125]

[0087] There are many possibilities for the patient data. Specific example details for the patient data, including measuring tools for measuring the patient data, are provided in Table 1 below. It is to be understood that Table 1 is very specific and is provided merely for exemplary purposes.

[0126] Table 1 - Patient Data and Measuring Tools for the Same

[0127] *P: Pearson correlation coefficient.

[0128]

[0088] The “POP-Q Interactive Assessment Tool” referenced in Table 1 refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women as is known to those skilled in the art. FIG. 10 is a schematic with variables measured using the POP-Q measurement system. The variables are listed below.

[0129] Table 2 - Variables Measured using POP-Q

[0130]

[0089] The POP-Q measurement system can be used to approximate the cervical angle 121. FIG. 1 1 is a graph of the cervical angle 121 vs. position within the vagina 100. On the left side 1 101 , the cervical angle 121 is indicated for various positions (i.e. lower region, middle region, and upper region) within the vagina 100. On the right side 1 102, for each position, a range of values is provided for the cervical angle 121 in percentile form based on a sampling of many vaginas, because vaginas can vary in terms of size and shape. In particular, for each position within the vagina 100, five cervical angles 121 are provided for 5thpercentile, 25thpercentile, 50thpercentile, 75thpercentile, 95thpercentile. For example, for the upper region, the cervical angles 121 include 10° for 5thpercentile, 28° for 25thpercentile, 41 ° for 50thpercentile, 56° for 75thpercentile, and 76° for 95thpercentile. Such variability in the cervical angle 121 bolsters the usefulness of obtaining patient-specific measurements with a view of customizing gynecological prosthetics. As shown by FIG. 1 1 , the cervical angle 121 in the upper region varies between 9 = 10° to 9 = 76° for most vaginas (i.e. excluding bottom 5% and top 5%), but as noted above a gynecological prosthetic can be designed for any cervical angle between 9 = -80° to 80°.

[0131]

[0090] The “Weighing Scale, Tape Measure, Calculator, BMI Table” referenced in Table 1 refers to any suitable means for assessing BMI of the subject as would be known to those skilled in the art.

[0132]

[0091] The “Software” referenced in Table 1 refers to the software that calculates geometry and / or material of the gynecological prosthetic based on patient data. See for example FIGs. 7A and 7B. The software can take inputs from clinicians. Clinicians can fill in the software with their obtained measurements including the digital measurements and POP-Q (shown in Table 1). These measurements may include vaginal hiatus, vaginal canal’s length, depth and width, the position of the anterior and the posterior fornix, width of the upper vagina, the width of the anterior and posterior fornix, the distance from posterior fornix to the pubis, distance between the ischial spines, position of the bones and other organs or tissues including but not limited to the sacrum, Pubic, ischial spines and the distance between them.

[0133]

[0092] These measurements along with other inputs including but not limited to BMI of the patient can be inserted into the software and be transferred to a mechanical model of the vagina. The BMI will be translated to the vaginal pressure. This vaginal pressure will be applied to the vaginal canal model in a simulation software / environment. The vaginal pressure is up to 106kPa and the Valsalva pressure is up to 58.87kPa. In some implementations, the customized gynecological prosthetic should not exceed these pressures + / -20kPa. The algorithm then will adapt our predetermined design of the gynecological prosthetic or any other design suitable for the patient and determine the final gynecological prosthetic according to the vaginal model and these input measurements.

[0134]

[0093] The “Measuring Tape or Caliper Tool” referenced in Table 1 can be a measuring tape which is a retractable finger size measuring tape that can be placed on one or more fingers and can be used to measure any distance and dimensions inside the pelvic cavity. One side of this tape can be fixed on a desired point and the other side can be expanded and locked in any desired point. Additionally, or alternatively, the “Measuring Tape or Caliper Tool” referenced in Table 1 can be a caliper that can be inserted and placed on the ischial spines and show the distance between them. In some embodiments, the “Measuring Tape or Caliper Tool” referenced in Table 1 is as described in WO2024 / 113063 published on 6 June 2024, the contents of which are herein incorporated in their entirety.

[0135]

[0094] The “Cervical Sizer Tool” referenced in Table 1 refers to a tool for measuring the cervix as would be known to those skilled in the art.

[0136]

[0095] In some implementations, the inputs from POP-Q (e.g. vaginal hiatus, vaginal canal’s length and depth, the position of the anterior and the posterior fornix) and digital / manual measurements (e.g. width of the upper vagina, width of the anterior, and posterior fornix, the distance from posterior fornix to the pubis, distance between the ischial spines, distance from symphysis pubis to ischial spines, and distance from coccyx to ischial spines) are transferred to a mechanical model of the vagina.

[0137]

[0096] There are many possibilities for the geometry and / or material of the gynecological prosthetic that can be calculated. Specific example possibilities for the geometry of the gynecological prosthetic are provided in Table 3 below. It is to be understood that Table 3 is very specific and is provided merely for exemplary purposes.

[0138] Table 3 - Gynecological Prosthetic and Vaginal Dimensions

[0139]

[0097] After the vaginal canal model is created based on these measurements, dimensions of the gynecological prosthetic can be calculated for both the upper plate and the bottom plate: length, width, height, angles of the upper plate and the upper links, length of the upper links, amount of material needed and direction of reaction force. For example, the cervical angle referenced in Table 3 can be used to design a tilt of an upper plate relative to a base plate as previously described.

[0140]

[0098] In some implementations, the mechanical and structural design is simulated using a numerical method, which is an approach of solving mathematical or physical equations using computers. This can be done by converting differential equations defined in continuous space and time to a large system of equations in discretized domain. See for example Brian H. Hahn, Daniel T. Valentine, Chapter 14 - Introduction to Numerical Methods, Editor(s): Brian H. Hahn, Daniel T. See also Valentine, Essential MATLAB for Engineers and Scientists (Sixth Edition), Academic Press, 2017, Pages 295-323, ISBN9780081008775, https: / / doi.Org / 10.1016 / B978-0-08-100877-5.00016-5.

[0141]

[0099] In some implementations, digital measurements are transformed into data usable by a predetermined shape based on initial design parameters of the patient specific gynecological prosthetic and the predetermined shape will change to the mentioned measurements. In some implementations, the vaginal model is parametric and it will depend and change based on each patient’s specific measurements. The parametric design can produce a customized design based on each patient’s specific measurements. In some implementations, the parametric design can be imported to finite element software to simulate the deformation of the gynecological prosthetic and the vagina under relevant environment in order to find suitable geometry. In some implementations, the vaginal model employs topology optimization in order to create a lighter gynecological prosthetic with the same functionality (i.e. reduce weight of the gynecological prosthetic without compromising functionality).

[0100] In some implementations, the inputs include: BMI, POP-Q measurements, Digital (manual) measurements (as shown in Table 1). In some implementations, the inputs may include any available data inputs obtained from clinicians including but not limited to any kind of medical imaging including but not limited to MRI, CT scans, ultrasound, or any device used for pelvimetry, or obtaining vaginal measurements. In some implementations, the BMI is translated into any form of vaginal pressure according to the correlation between BMI and intravaginal pressure or force.

[0142]

[0101] In some implementations, the mentioned measurements (shown in Table 1) are used in an Al / machine learning model. This model can be trained based on this data. The mechanical parameters of the gynecological prosthetic (either predetermined or not) can be designed by this algorithm resulting in finding a suitable model of the gynecological prosthetic for each particular patient. To find the suitable customized design ML / AI models can be trained on the data from measurements and mathematical models (e.g. Finite element analysis). ML / AI models can predict the suitable input design parameters (including but not limited to shape, dimension, angles, materials) to reach the best performing customized design. Algorithms can be based on Neural Networks and / or other optimization algorithms. In some implementations, parameters and hyperparameters are used in the Al. Hyperparameters of the ML models can be tweaked using different optimization algorithms. For example, in neural networks, these involve a number of layers and number of iterations, etc.

[0143]

[0102] In some implementations, the geometry of the gynecological prosthetic that can be calculated includes at least some of length of anterior anchor member, length of posterior anchor member, gynecological prosthetic length, gynecological prosthetic width, an angle of upper plate relative to base plate, length of connecting links, length of upper links, size of the upper plate, position of the upper plate in relation to the base plate, length of side anchor members, dimensions of the upper plate, thickness of connecting links, and thickness of the upper links. Other implementations are possible.

[0144]

[0103] In some implementations, there is provided an anatomical model of the vaginal canal that includes the position of the ischial spines, cervical angle which is the angle between the uterus and vaginal axis or between the cervical axis and vaginal axis. This cervical angle can vary between 10° and 76° (or 9 = -80° to 80° as described earlier). Also, the middle region of the vaginal axis can vary between 45° and 114°. The lower region of the vaginal axis can vary between 73° and 107°.

[0145]

[0104] Referring now to FIG. 12, shown is a flowchart of an exemplary process for providing a user with a user specific therapeutic device (USTD), in accordance with an embodiment of the disclosure. The process can reduce a bewildering array of USTD types and dimensions to a single USTD option without significant effort from either the patient or the clinician. Accordingly, at step 1210 the process begins with the step of Measurement and Characterisation (M&C) 1210 before progressing to Analysis and Modelling (A&M) 1220 and Custom Device Manufacturing and Fitting (CUDEMAF) 1230 wherein the patient (user) is now provided and fitted with a custom USTD. Next, the process proceeds to step 1240 wherein ongoing monitoring of quality of life (QoL) and performance of the USTD wherein a decision process 1250 may determine whether the objectives of the USTD are being met or still being met on an ongoing basis and hence determine whether monitoring should continue or whether the process should begin again with step 1210. An ongoing monitoring and cyclic process may be appropriate for a variety of USTD use cases including, but not limited to, changing physical characteristics of the user, changing physiology of the user, and degradation of the USTD. Accordingly, as depicted M&C 1210 comprises three sub-processes, these being, Structural 1212, Force, Strain and Distension 1214, and Quality of Life 1216.

[0146]

[0105] Within embodiments of the disclosure, the custom USTD 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 disclosure, a USTD according to an embodiment of the disclosure may exploit an energy delivery system such as infrared irradiation or ultraviolet irradiation for example. A custom USTD may also be employed in conjunction with other medical procedures and / or treatment regimens including, for example, exploitation of stem cells.

[0147]

[0106] Structural 1212 may comprise one or more measurements 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. Examples of such measurements have been described above and are not repeated here.

[0148]

[0107] Force, Strain and Distension 1214 may comprise one or more measurements of characteristics of the user's anatomy and / or measurements of the user's physical characteristics, for example to ascertain BMI and calculate pressure based on the same, as previously described. The measurements performed within Structural 1212 and Force, Strain and Distension 1214 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 walking, exercising, running, lifting, bending, etc. In contrast to the Structural 1212 and Force, Strain and Distension 1214 the Quality of Life 1216 is an assessment.

[0108] Quality of Life (QoL) 1216 may include, but not limited to, current QoL data for the user (patient), QoL goals for the user (patient), symptoms experienced by the user, and user lifestyle. Accordingly, QoL 1216 can establish baseline QoL data which may be employed subsequently for the monitoring, QoL and performance of the USTD once manufactured and employed according to embodiments of the disclosure. Accordingly, for one user a QoL goal may be the elimination of a symptom that occurs only during sexual activity whilst for another it may during a specific exercise, sporting activity, etc. or for another over specific periods of time and / or generally monitored etc. Additionally, the USTD in terms of being permanent, semi - permanent, or temporary is established wherein for temporary use at least the installation I removal means and / or mechanisms are established with the user. For permanent and semipermanent the installation I removal means are geared primarily to the clinician rather than the user.

[0149]

[0109] In establishing the QoL 1216 a user may employ an application upon a PED and / or FED in order to track the user's (patient's) perceived QoL, to monitor and / or log even occurrences such incontinence, pain, prolapse, gynecological prosthetic fall out, etc. From M&C 1210 the process proceeds to A&M 1220 wherein sub-processes of Assessment 1222 and Performance Goals 1224 are undertaken. Within Assessment 1222 the data obtained within the M&C 1210 step are analysed, for example, through their entry into a human body (anatomical) model (HBM) of the appropriate body region or body regions to define a series of two-dimensional (2D) and / or three-dimensional (3D) perspectives of the user's anatomy as well as other parameters.

[0150]

[0110] Within Performance Goals 1224 the QoL 1216 data is established as specific static and dynamic performance goals for the USTD, axes of motion, motional limits, rotational limits, loading, pressure etc. These aspects may include, but are not limited to, whether the USTD is to address long term or short term issues, whether the USTD is to address recurring episodes together with frequency etc., degree of comfort level desired, will or can the user perform self-removal I cleaning I insertion etc., will this involve periodic visits to a physician or clinic, and will any coatings involve the user periodically dispose of the USTD and use a new USTD. Additionally, additional characteristics may be established with respect to providing an antimicrobial coating, providing controlled pharmaceutical product release(s) such as proteins, regenerative medicine(s), pain killers, or other drugs for the user. These together with the data from Assessment 1222 are employed in defining the custom USTD for the user in terms of physical geometry, e.g. dimensions of any ring structure, knob, support etc. Additionally, the mechanical properties of the custom USTD are defined in respect of the flexibility, dimensional stability, installation / removal means, physical characteristics of the USTD such as smooth / contoured surfaces and / or regions, etc. as well as other aspects such as any locking and / or release mechanisms.

[0151]

[0111] Based upon the established mechanical and physical specifications together with appropriate aspect of the QoL specifications the process in CUDEMAF 1230 proceeds with a sequence comprising Manufacture 1232 and Fitting 1234. The accumulated data from the Analysis & Modelling 1220 as defined within Assessment 1222 and Performance Goals 1224 is coupled to an Artificial Intelligence (Al) Engine 1260 which employs a plurality of algorithms which may exploit one or more approaches including, but not limited to, those based on symbol manipulation, cognitive simulation, logic-based programming, anti-logic programming, natural language processing, knowledge based, sub-symbolic, embodied intelligence, computational intelligence and soft computing, and statistical either individually or in combination such as within methodologies such as the intelligent agent, multiple interacting agents in a multi-agent system, and a hybrid intelligent system.

[0152]

[0112] Within Manufacture 1232 the custom USTD is defined in respect of the materials providing its physical geometry with the desired mechanical properties as well as external characteristics. Accordingly, the custom USTD may be defined by one or more aspects including, but not limited to:

[0153] • Scaffold structure by dimension(s), material(s) etc.

[0154] • Shell structure by dimension(s), material(s) etc.

[0155] • Casing structure by dimension(s), property or properties, material(s).

[0156] • Passive - active integration such as is USTD passive or does it embed sensor(s), control and / or data logging circuitry, wireless interface(s) etc.

[0157] • Lock-release structure.

[0158] • Coatings.

[0159]

[0113] Accordingly, a CAD model is established from which the Manufacture 1232 process is undertaken. Within an embodiment of the disclosure, an initial CAD model may be established by combining three-dimensional (3D) modelling with computational fluid dynamics (CFD), finite element analysis (FEA), finite element model (FEM), and / or multi-organ free-body diagram models. The CAD model may be simplified to reduce the computational power and complexity of the processing applied priorto the Al Engine 1260 executes. The Al Engine 1260 may process based upon this initial pre-processing solely or may apply the preprocessing to a more complete human body (anatomical) model and USTD model in order to define the USTD design, CAD, and materials specifications. Optionally, the pre-processing may be bypassed where appropriate levels of computing resources are available. Accordingly, a USTD as designed and manufactured may range from a passive USTD through to an active USTD, with lock-release structure, anti-microbial coating, and wireless interface for transmitting data logging data relating to the user.

[0160]

[0114] Optionally, within embodiments of the disclosure, the USTD may in addition to sensors include actuators that apply pressure to predetermined regions of the user or may support the user's body motion. Optionally, the USTD may provide controlled release of one or more pharmaceutical agents such as by opening a reservoir to expose said one or more pharmaceutical agents, employ microneedles to inject one or more pharmaceutical agents, etc.

[0161]

[0115] Within Fitting 1234 the custom USTD is provided to the user and either fitted by themselves, e.g. for temporary use USTD that the user will insert / remove as desired, or by a clinician, e.g. semi-permanent or permanent use. At this point one or more assessments may be carried out such as outlined previously in respect of Structural 1212 and / or Force, Strain and Distension 1214 whereby mechanical, imaging, static and / or dynamic assessment etc. are performed to assess the USTD fit against the target design I user physiology etc. This stage may also include device monitoring, e.g. via internal sensors to the USTD, as well as user monitoring, e.g. by personally noting performance of the USTD etc. Based upon these results a determination is made as to whether the USTD meets the initial specifications wherein if the determination is positive then the process proceeds to step 1240. If not, then the process proceeds to loop back to either A&M 1220 or CUDEMAF 1230 according to the nature and / or complexity of the modifications I amendments to be made.

[0162]

[0116] In step 1240 the user employs the USTD on an ongoing basis wherein device monitoring, e.g. via internal sensors to the USTD, as well as user monitoring, e.g. by personally noting performance of the USTD etc. are performed wherein periodically this data is employed in determining whether the objectives for the USTD were met in step 1250. If yes, then the process loops back to step 1240 otherwise it proceeds back to step 1210. For example, a young user may have multiple USTDs within the space of a few years I decade during their childhood, adolescence, puberty, etc. with evolving dimensions and considerations whereas an elderly user may get by with a single adjustment or no adjustment according to their circumstances.

[0163]

[0117] FIG. 15 describes a gynecological prosthetic customization system 1500 in accordance with various embodiments of the present disclosure. The gynecological prosthetic customization system 1500 builds on the gynecological customization system 500 described above with reference to FIG. 5. Additional reference is made to FIGS. 6 to 12 in that the features described in the foregoing with reference to these figures are implemented by the gynecological prosthetic customization system 1500 of FIG. 15.

[0118] The gynecological customization system 1500 provides a medical technology system designed for the customized design and fitting of gynecological prosthetics, such as pelvic organ prolapse (POP) pessaries, to address the needs and unique physical characteristics of individual patients in some embodiments. However, other gynecological prosthetics can benefit from the customization methods described herein such as, but not limited to, diaphragms, contraceptive rings, disks or cups, vaginal stents, vaginal dilators, hormone delivery prosthetics, cervical drains, vaginal prosthesis for control of vesicovaginal fistula, etc., customized vaginal dilators and stents for post-operative treatment from vaginal reconstruction surgery or for the prevention of vaginal stenosis from post-cancer therapy, customized sexual wellness and menstrual products not limited to menstrual cups, menstrual rings or disks for women with wider or shorter cervixes, contraceptive vaginal rings, and more, customized cerclage pessaries for the prevention of pre-term labour for women with cervical incompetence.

[0164]

[0119] The gynecological customization system 1500 combines various technologies and processes to ensure an optimal fit and performance of a pessary (or other gynecological prosthetic) within a patient's vaginal canal. The pessary may be a prosthetic according to any of the foregoing pessaries 200, 300, 400, 1700, 1800, 1900, 2000, 2100, 2200, 2300 or according to some other base design. As such, the description of the pessary provided above is applicable to the gynecological customization system 1500.

[0165]

[0120] The gynecological customization system 1500 receives a set of measurements and data for an individual patient, including anatomical measurements related to their vaginal canal and optionally pelvic organ prolapse conditions. The measurements include parameters such as POP-Q measurements, Total Vaginal Length (TVL), Anterior and Posterior wall measurements, width of the vaginal canal including but not limited to the width of the upper vagina, mid vagina and lower vagina, BMI, Intra-Abdominal Pressure (IAP), Intravesical Pressure (IVP), and other relevant anatomical data as described previously. The gynecological customization system 1500 may optionally use this patient-specific data to create a parametric design of the patient's vaginal canal. This parametric model adapts to the patient's unique measurements and conditions, ensuring a personalized fit.

[0166]

[0121] The gynecological customization system 1500 performs a (FEA) simulation to analyze how the pessary interacts with the patient's vaginal canal. The simulation provides insights into mechanical performance, including displacement, reaction forces, deformation, safety factors, stress and strain distribution, and potential energy. A machine learning algorithm is utilized to optimize the pessary design. The machine learning algorithms iteratively or non iteratively adjust pessary parameters, such as height, dimensions (including volume), and angles, to achieve the best fit and performance for the patient. The ML model outputs the optimized pessary parameters based on the simulation results / response. These parameters guide the design of a custom pessary tailored to the patient’s specific needs. The custom pessary design is 3D printed using advanced printing techniques such as DLP (Digital Light Processing) or SLA (Stereolithography), selective laser sintering (SLS), fused deposition modeling (FFF), FDM to ensure accuracy and quality. The printed pessary is ready for clinical use after required post processing such as cleaning. After fitting the customized pessary, patients can undergo follow-up evaluations and, if necessary, further adjustments to ensure the best fit and comfort.

[0167]

[0122] The gynecological prosthetic customization system 1500 can include a variety of modules including a vaginal canal model module 1506, a pessary design module 1512, a Finite Element Analysis (FEA) module 1510, a Machine Learning model module 1518 and a 3D printing module 1524. As used herein, the term module refers to any hardware, software, firmware, electronic control component, processing logic, and / or processor device, individually or in any combination, including without limitation: application specific integrated circuit (ASIC), an electronic circuit, a processor (shared, dedicated, or group) and memory that executes one or more software or firmware programs, a combinational logic circuit, and / or other suitable components that provide the described functionality. The modules described herein may be implemented as software programming instructions stored on computer readable medium 518 (see FIG. 5) and executed by the processor 516.

[0168]

[0123] The gynecological prosthetic customization system 1500 receives input data 1502. The input data 1502 can originate from various sources (as described previously), both locally and remotely, and may be transmitted over the network 502 to a central computing device (e.g., computing device 510). The input data 1502 is used for tailoring pessaries to individual patients. The input data 1502 may include patient demographics such as personal information, including age, gender, and contact details, which can be manually entered by the patient or a clinician through the user interface 511 or any of the connected client devices of desktop 531 , tablet 532, smartphone 533 and laptop 534.

[0169]

[0124] The input data 1502 can include anatomical measurements, which may be taken manually by a clinician, such as using measurement devices including but not limited to mechanical tools (e.g. calipers, measurement gloves, tapes) or digital tools, or derived from one or more scanning devices such as ultrasound, CT, MRI, etc. The anatomical measurements can include POP-Q measurements whereby a clinician can manually assess the Pelvic Organ Prolapse Quantification (POP-Q) parameters, which include (with reference to FIG. 10) Point Aa, Point Ba, Point C, Point D, Point Ap, Point Bp, GH (Genital Hiatus), PB (Perineal Body), and TVL (Total Vaginal Length). These measurements may be obtained during a pelvic examination.

[0170]

[0125] The input data 1502 may include urodynamic measurements and reports of the patient (these measurements also indicate the pressure of the different pelvic organs in relation to one another). These measurements usually involve the insertion of a catheter into the urethra or rectum. These measurements can also go under mathematical operations and / or equations and get translated to a useful applicable value for the pressure to the vaginal canal module or the pessary design module.

[0171]

[0126] The input data 1502 can include BMI (Body Mass Index). The patient's weight and height may be manually measured to calculate their BMI, providing an estimate of their body composition and abdominal pressure. Other indicators of body composition may be provided in the input data 1502 in addition to, or as an alternative to, BMI. Various scanning technologies may be used to assess body composition. This assessment of body composition may provide body composition data as part of the input data 1502 or can be used to determine BMI. Exemplary technologies include: Dual-energy X-ray Absorptiometry (DXA) and Bioelectrical Impedance Analysis (BIA). DXA scans can provide detailed information about bone density, muscle mass, and body fat percentage. BIA devices measure the impedance (resistance) of electrical currents as they pass through the body. This technology can estimate body fat and lean mass, which can be used in conjunction with weight and height to calculate BMI (for example).

[0172]

[0127] The input data 1502 may include vaginal canal measurements. Exemplary vaginal canal measurements may include distance between ischial spines (as described above with reference to FIGS. 9A and 9B). The distance between the patient’s ischial spines may be measured manually to define the vaginal canal’s maximum expansion or this distance may be derived, by automated algorithm or manually, from a scan of that region. Vaginal canal measurements may include the distance between ischial spines and pubic symphysis (as described above with reference to FIGS. 9A and 9B). The distance between the ischial spines and the pubic symphysis is measured to help determine the placement of the pessary. The input data 1502 may include vaginal canal width data. The width of the vaginal canal may be measured through its length (lower vagina, mid vagina and upper vagina) to help determine the dimensions of the pessary design module (1512).

[0173]

[0128] The patient input data can include vaginal tactile imaging (VTI) data or parameters derived therefrom. Data from vaginal tactile imaging devices, if available, can be remotely transmitted. VTI data can provide pressure profiles and may include information on the vaginal canal's physical characteristics and response to applied pressure. VTI is a medical probing technique that can provide valuable data related to the mechanical properties of the vaginal canal and surrounding tissues. Exemplary parameters that can be obtained from VTI and included as part of the input data 1502 can include any of the following. One parameter may be tissue stiffness. The VTI can assess the stiffness or elasticity of vaginal tissues. It provides information about how soft or firm the tissues are. Stiffness data supports understanding conditions like pelvic organ prolapse (POP) and evaluating the effectiveness of treatments or interventions. Another parameter may be pressure distribution. VTI can measure pressure distribution within the vaginal canal. This information supports evaluating the impact of interventions such as pessaries or surgical procedures on pressure management. Tissue deformation is another parameter that may be provided by VTI. VTI allows forthe measurement of tissue deformation or strain when external forces are applied. This data supports understanding how the vaginal canal responds to various loads or mechanical stresses. Another exemplary parameter includes tissue displacement. VTI can track the movement or displacement of vaginal tissues during different activities or interventions. This data is useful for assessing the effectiveness of treatments and interventions aimed at addressing prolapse or incontinence. VTI may allow data describing dynamic behavior to be provided by capturing dynamic changes in vaginal tissue properties, such as how they respond during activities like coughing, sneezing, or physical exertion. This information supports understanding the dynamics of pelvic floor function. VTI can provide support and prolapse data to help evaluate the level of support provided by pelvic floor muscles and assess the degree of prolapse (e.g., cystocele, rectocele, uterine prolapse). The VTI data can provide data about the location and extent of tissue descent. The VTI data can include pressure profiles. For example, VTI can generate pressure profiles related to intra-abdominal, intra-vaginal, and intra-rectal pressures. These profiles support understanding the interaction of pressures within the pelvic region.

[0174]

[0129] The input data 1502 can include imaging data (MRI, CT scans, ultrasound) or parameters derived therefrom. Radiological imaging data, such as MRI or CT scans, or other imaging data can be obtained remotely and transmitted over the network 502. These images can provide detailed information about the patient's anatomy, which will be useful for accurate modelling. Transvaginal or transabdominal ultrasound can provide dimensional data on various pelvic structures, including the vaginal canal, uterus, ovaries, and bladder. It is commonly used for prenatal care and gynecological evaluations. Magnetic Resonance Imaging (MRI) can offer detailed three-dimensional images of the female pelvis, allowing for measurements and assessments of pelvic organs, vaginal dimensions, and other anatomical structures. Computed Tomography (CT) scans can provide detailed cross-sectional images of the pelvis and other areas of the body. They are valuable for diagnosing conditions and assessing anatomical dimensions.

[0130] The input data 1502 can include pressure indicative data derived from BMI or measured. The pressure indicative data can include Intravesical Pressure (IVP). The pressure indicative data can include Intra-Abdominal Pressure (IAP): representing the pressure inside the abdominal cavity and can be used to simulate the effect of intra-abdominal pressure on the pessary with respect to ensuring that the pessary remains in place and functions properly, especially when dealing with conditions like pelvic organ prolapse. The pressure indicative data can include intravaginal pressure, which can support understanding how the pessary interacts with the vaginal walls and the pressure exerted by the vaginal canal on the pessary. The pressure indicative data can include pressure from adjacent organs, such as the bladder or rectum, which can influence the behavior of the pessary. The pressure indicative data can include pressure from muscle contractions such as pressures exerted by pelvic floor muscles, which can be used to evaluate the pessary's response to muscle contractions and its ability to provide the necessary support. The pressure indicative data can include pressure changes during activities, which may be collected during different activities (e.g., coughing, sneezing, exercising) and can support assessing how the pessary performs under varying conditions and to make adjustments for optimal support. The simulations described below may also provide pressure distribution on a pessary surface by evaluating how pressure is distributed across the surface of the pessary, helping to ensure that it exerts the intended pressure on the vaginal walls and provides support where needed. A function of using this pressure indicative data in simulation is to replicate real-world conditions and behaviors of the pessary within the vaginal canal. It helps in fine-tuning the pessary design and ensuring that it meets its intended purpose, whether that's providing support for pelvic organ prolapse, managing stress urinary incontinence, or addressing other gynecological conditions. The pressure data aids in optimizing the pessary's performance and minimizing any discomfort or complications for the patient. The pressure indicative data is described further below.

[0175]

[0131] Pressure indicative data may also be measured more directly than based on BMI measurements for the patient. For example, vaginal manometry is a tool used to measure pressures within the vaginal canal and pelvic floor muscles. It can assess muscle function and detect abnormalities in pressure patterns. Perineal pressure sensors are placed in the perineal region to measure pressures in the area between the vaginal and anal openings. They can provide information about pelvic muscle tone and function. Intravaginal pressure sensors may be inserted into the vaginal canal to measure pressures at specific locations. They may be used to evaluate conditions like pelvic organ prolapse (POP) and stress urinary incontinence (SUI), Other specialized diagnostic devices may be used for measuring pressures within the vaginal and pelvic area. These devices can provide comprehensive data for diagnosing and managing pelvic health issues.

[0132] The input data 1502 may also include machine learning predictions. Over time, the gynecological prosthetic customization system 1500 may use machine learning models to predict certain parameters based on the available data, reducing the need for manual measurements.

[0176]

[0133] The input data 1502 provides a comprehensive patient profile. This profile guides the parametric design of the patient's vaginal canal (which is an optional step) and the customization of the pessary (or other gynecological prosthetic) to address their unique pelvic organ prolapse condition (or other gynecological condition) effectively.

[0177]

[0134] In some embodiments, the vaginal canal model module 1506 creates a 3D model of the vaginal canal tailored to individual patients. The creation of the vaginal canal 3D model may comprise adapting a template vaginal canal model with the patient’s data. The vaginal canal model module 1506 receives the input data 1502 in the form of patient data 1504. As described with respect to the input data 1502, the patient data 1504 includes patient-specific measurements. The patient data 1504 includes, for example, parameters such as total vaginal length (TvL), genital hiatus (GH), perineal body (Pb), vaginal canal width, distances between various anatomical landmarks, and pressure profile data. The vaginal canal model module 1506 utilizes these measurements to create a personalized model. The patient data 1504 may include (if available) data from a preclinical bone detection algorithm to incorporate bony structures into the model, enhancing anatomical accuracy. These measurements are usually obtained from medical imaging techniques like CT scans and can be algorithmically detected and measured or determined by manual marking of bone locations and algorithmic measurement. In some embodiments, the measurements may be obtained from a predetermined and pre-detected CT scan from other datasets that adapts to each patient's data using obtained measurements such as distance between ischial spines or ischial spines to pubis and coccyx.

[0178]

[0135] The vaginal canal model module 1506 outputs a 3D vaginal canal model in the form of 3D vaginal canal model data 1508. The 3D digital model of the patient's vaginal canal represents the patient's anatomy based on the provided measurements included in the patient data 1504. The vaginal canal model module 1506 may also provide data regarding anatomical landmarks within the vaginal canal, such as the positions of the cervix, bladder, rectum, and other structures, which are included in the 3D vaginal canal model data 1508.

[0179]

[0136] The vaginal canal model module 1506 may perform various algorithmic processes to generate the 3D vaginal canal model. The processes may include parameter integration in which patient-specific measurements included in the patient data 1504 are integrated into 3D modeling software. For example, measurements such as TvL are used to determine an overall length of the vaginal canal in the model. The vaginal canal model module 1506 ensures that the 3D model accurately reflects the patient's anatomy, taking into account the dimensions, landmarks, and conditions specified by the measurements in the patient data 1504. The vaginal canal model module 1506 may adjust the model's dimensions, curvature, and shape accordingly. If preclinical bone detection data is available, the vaginal canal model module 1506 incorporates this information to include bony structures such as the pelvic bones in the 3D model. This may be relevant for simulating interactions between the pessary and bony structures within the pelvis. The pressure profile data included in the patient data 1504, which is typically derived from Vaginal Tactile Imaging (VTI) and / or translated from the patient's BMI, may be used to simulate pressure variations within the vaginal canal. The module incorporates this information to model how the vaginal tissues respond to different pressures. This may also be performed during the FEA simulation. In embodiments, the vaginal canal model module 1506 generates a mesh representation of the 3D model, allowing for finite element analysis (FEA) simulations. The mesh divides the model into smaller elements for accurate mechanical simulations.

[0180]

[0137] In some embodiments, the vaginal canal model module 1506 is not present and FEA simulations and pessary design are performed based on the patient data 1504 without generating a model, as will be described further below.

[0181]

[0138] In some embodiments, the pessary design module 1512 is a component of the gynecological prosthetic customization system 1500 responsible for generating customized designs for pessaries based on a patient's anatomical and physiological data. The pessary design module 1512 (or other gynecological prosthetic design module) may receive the 3D vaginal canal model data 1508 providing a 3D model of the patient's vaginal canal. This digital model serves as a foundation for designing a pessary (or other gynecological prosthetic) tailored to the patient's anatomy. The 3D vaginal canal model data 1508 embodies patient-specific measurements including parameters like Total Vaginal Length (TvL), Genital Hiatus (GH), Perineal Body (Pb), and other anatomical data. In other embodiments where the vaginal canal model module 1506 is not present, the pessary design module 1512 operates directly on the patient data 1504.

[0182]

[0139] In some embodiments, reference pessary data 1530 is provided embodying a reference pessary (or other gynecological prosthetic) design. The reference pessary serves as a starting point for design optimization. The reference pessary may be randomly selected from a database of reference pessaries (e.g. database 520 in FIG. 5) and placed inside the vaginal canal model to initiate a parametric design optimization iteration. The reference pessary's characteristics, including its shape and / or dimensions, influence the initial design parameters. In other embodiments, the reference pessary is selected by finding a closest match with the 3D vaginal canal model (or a closest match with selected parameters in the patient data 1504) based on one or more parameters defining physical dimensions of the vaginal canal. For example, the width of the mid vaginal canal may be used to select an appropriate reference pessary.

[0183]

[0140] In some embodiments, adjusted pessary data 1520 is provided from the ML model module 1518 to instruct changes in certain parameters according to optimization loops performed between the FEA module 1510 and ML model module, as described in further detail below.

[0184]

[0141] The pessary design module 1512 outputs 3D pessary model data 1514 digitally defining a fully customized pessary (or other gynecological prosthetic) design. This design includes specific dimensions, shape, and features tailored to the patient's anatomy and condition. The design is in a digital format and can be used for further processing in an optimization loop including the FEA module 1510 or it can be used in 3D printing if the optimization loop has been completed upon a convergence condition being achieved. The 3D pessary model data 1514 provides detailed specifications for the pessary design, including dimensions, angles, fillet radii, and any other relevant design parameters. These specifications guide the manufacturing of the physical pessary.

[0185]

[0142] In some embodiments, the FEA module 1510 receives a 3D pessary model in the form of 3D pessary model data 1514 digitally representing a customized pessary (or other gynecological prosthetic) in the form of a digital model that represents the physical geometry of the pessary. The FEA module 1510 further receives a 3D vaginal canal model (as an optional feature) in the form of 3D vaginal canal model data 1508, which serves as the environment in which the pessary will be placed for simulation. Patient-specific measurements may further be provided in the form of patient data 1504, which include parameters such as Total Vaginal Length (TvL), Genital Hiatus (GH), Perineal Body (Pb), and other anatomical data as listed in Table 1 and described herein. These measurements inform the simulation by defining the patient's unique anatomy and condition. Pressure profile data (or any pressure indicative data as described above), which may be translated from the patient's BMI, is provided in the patient data 1504 for simulating the distribution of intra-abdominal and intra-vaginal pressures within the vaginal canal. This data helps assess how the pessary responds to specific pressure conditions.

[0186]

[0143] Alternatively, the simulation is performed without simulating the vaginal canal, but by use of the pressure indicative data and / or one or more of the measurement data from 1504.

[0144] The FEA module 1510 may output a set of performance indicators that assess how the pessary interacts with the patient's vaginal canal. These indicators may include displacement, deformation, stress distribution, reaction forces, safety factors, strain, and more and any combination of two or more of these indicators. These indicators help evaluate the performance and effectiveness of the pessary (or other gynecological prosthetic).

[0187]

[0145] The FEA module 1510 simulates how the customized pessary interacts with the patient's vaginal canal. The simulation process may include the following steps. A mesh generation step may be performed in which the 3D models of the pessary and vaginal canal are divided into smaller elements or nodes to create a finite element mesh. This mesh helps in representing the geometry accurately and solving simulation equations. The FEA may access (from a database) or generate boundary conditions that are defined based on the interaction between the pessary and the vaginal canal. This includes specifying how the pessary is anchored or placed within the vaginal canal. The FEA module may incorporate material properties (accessed from a database or provided as inputs by a human designer), such as the mechanical characteristics of the pessary material and the vaginal tissue, into the simulation. These properties influence the pessary's behavior under different conditions. The pressure indicative data, which may include intra-abdominal and intra-vaginal pressures, is applied to the simulation. The FEA module 1510 simulates how these pressures affect the pessary's position and deformation. The FEA module 1510 may employ a finite element solver to calculate the pessary's response to the applied loads, material properties, and boundary conditions. It computes various performance indicators, such as displacement, stress, and deformation. The FEA module 1510 outputs performance indicators in the form of pessary performance data 1516 as a result of the simulation. The pessary performance data 1516 describes how the pessary performs within the patient's vaginal canal. These indicators include measures of displacement, deformation, pressure distribution, reaction forces, stress and strain levels, safety factors, and more and combinations of any two thereof. The pessary performance data 1516 obtained from the FEA module 1510 is then used to guide further adjustments in the pessary design (or other gynecological prosthetic) through the ML model module 1518, creating an iterative optimization loop.

[0188]

[0146] In some embodiments, the ML model module 1518 receives the pessary performance data 1516 providing a set of performance indicators generated by the FEA module 1510. The ML model module 1518 may further receive patient-specific data in the form of patient data 1504, which includes anatomical measurements (e.g., Total Vaginal Length, Genital Hiatus, Perineal Body, BMI, etc.) and clinical information about the type and stage of pelvic organ prolapse. This data helps customize the pessary design for each patient. The ML model module 1518 provides a set of optimized parameters for the pessary design in the form of adjusted pessary data 1520. These parameters define adjustments to the pessary's dimensions, shape, and other characteristics, which may be provided to the pessary design module 1512 to adjust the 3D pessary model, which may then be fed back to the FEA module 1510 to begin the optimization loop anew. The ML model module 1518 determines the adjustments required to make the pessary perform optimally based on the FEA performance indicators and patient-specific data.

[0189]

[0147] The ML model module 1518 optimizes the pessary design based on the FEA simulation and patient-specific data. The ML model module 1518 may include a data initialization step by preprocessing the pessary performance data 1516, cleaning the data, and ensuring its consistency. Patient-specific data is also prepared for input into the ML model. Feature engineering may be employed to extract relevant features from the pessary performance data 1516 and the patient data 1504. The ML model module may employ machine learning models, such as Neural Networks, Support Vector Machines (SVM), Random Forest, or other regression models or any other Machine learning I Deep learning model. The chosen ML model can be trained to optimize the pessary parameters.

[0190]

[0148] In embodiments, the ML model is trained using reference preprocessed data. The model learns the relationships between the FEA performance indicators, patient-specific data, and the adjustments needed for the pessary parameters. The loss function used during training quantifies the difference between the actual FEA performance indicators’ ideal values and the model's predictions. In this way, the ML model is trained to predict performance parameters to adjusted pessary design parameters and thus to optimize the pessary parameters within the design space to reduce a difference between target performance and predicted performance. Hyperparameters of the ML model may be tuned to improve its performance. Hyperparameter optimization aims to achieve the best possible convergence and accuracy of the model.

[0191]

[0149] The ML model recommends adjustments to the pessary design parameters, such as dimensions, shape, angles, thickness, or material properties. These adjustments are determined to optimize the pessary's performance within the patient's vaginal canal. The ML model module 1518 operates in an iterative feedback loop. After each iteration, it assesses whether the recommended pessary parameters have led to improved performance, as indicated by the FEA performance indicators of the pessary performance data 1516. If convergence is reached, meaning the recommended pessary parameters consistently yield optimal performance according to a certain threshold of stability, the optimization loop stops. Otherwise, the optimization process continues. Advantageously, unlike prior art systems, a full factorial with all the different combinations is avoided. Therefore, by means of the embodiments of the present technology, a computational requirement is reduced. Instead, in embodiments of the present method, a subset of all the combinations are reviewed which are those that are most likely.

[0192]

[0150] A final output of the ML model module 1518 is a set of optimized pessary parameters in the form of adjusted pessary data 1520. These parameters are then used to create the final 3D design of the pessary (or other gynecological prosthetic) by the pessary design module 1512, which is suitable for 3D printing and deployment in clinical practice.

[0193]

[0151] In the foregoing, the ML model module 1518 operates in an indirect optimization method. A direct optimization method is also envisaged, as will be described below. In the indirect optimization method, the ML model interacts with the FEA module 1510 in an iterative process. The ML model uses the FEA simulation's responses in the form of pessary performance data 1516 to guide the adjustment of design parameters to provide adjusted pessary data 1520, with the goal of achieving desired performance within specified response ranges. That is, an input of the simulation by the FEA module 1510 will be the design initial parameters according to a first instance of the 3D pessary model data 1514. Then, the FEA simulation is run for a single round, to provide responses of the vaginal canal to the input parameters in the form of pessary performance data (such as displacement amount, etc). The pessary performance data 1516 along with the design inputs in the form of 3D pessary model data 1514 are input to the ML algorithm embodied by the ML model module 1518 and the ML model will be trained on these. An optimum(desired) response range for the pessary performance data 1516 may be defined according to settings made by a clinician’s target and the condition of the patient. These ranges are ideal scenarios (labels). The machine learning model module 1518 provides a new design parameter suggestion in the form of adjusted pessary data 1520 that gets back to the simulation by the FEA module 1510 for the next run. These exchanges happen iteratively until a convergence condition is satisfied. After all the iterations are complete, the final optimized parameters for the pessary are output in the form of 3D print data.

[0194]

[0152] In an alternative embodiment, a direct optimization method is implemented, whereby the ML model module 1518 directly maps design parameter ranges to response ranges without the need for an iterative exchange with the FEA module 1510. The ML model module operates based on predefined parameter ranges and response ranges. In this case, the ML model may not interact with the FEA module 1510 iteratively as it does in an indirect optimization method. That is, another possible optimization option is to give a range of each of the design parameters for the pessary as inputs and feed these into a simulation by the FEA module 1510. Then, after the run for these values, a range of pessary performance values in the pessary performance data 1516 is output. These output ranges in pessary performance data 1516 along with the pessary design input range is input to the ML model module 1518 to be trained on. Such a ML model module 1518 can operate without iterative returning to the FEA module 1510 on the basis that a range of pessary performance values are provided that can be associated with a range of input 3D pessary model parameters. The ML model module 1518 is functionally searching the trained space of input 3D pessary model data ranges and associated pessary performance data 1516 generated by the single instance of the FEA module to directly find a function that fits these input parameters and to find optimum output parameters for the pessary design without recurrence to the FEA module 1510.

[0195]

[0153] The 3D printing module 1524 in the gynecological prosthetic customization system 1500 is responsible for translating the optimized pessary design defined by 3D print data 1522 into a 3D printable file or a physical, tangible object. The tangible object may comprise one or more of: a physical pessary 1526, a mold of the physical pessary 1526, or a physical model of the vaginal canal. The 3D print data 1522 may be provided by computing device 510 over the network 502 to a 3D printing tool. The 3D printing module 1524 may utilize various 3D printing techniques to create the final pessary by controlling a 3D printing tool (not shown). The 3D print data 1522 defines the dimensions, shape, and other characteristics of the pessary (or mold of the physical pessary 1526, or a physical model of the vaginal canal). The 3D printing module 1524 converts the optimized design parameters into an actual pessary (or mold of the physical pessary 1526, or a physical model of the vaginal canal) via a 3D printing tool. The 3D printing tool may use an appropriate 3D printing material that is safe for medical use and suitable for creating a pessary or (mold of the physical pessary 1526, or a physical model of the vaginal canal). Common materials for medical 3D printing include biocompatible plastics like PLA, ABS, or medical-grade silicone or any other silicone based material.

[0196]

[0154] The 3D printing module 1524 may use a variety of 3D printing techniques including any of the following. Fused Deposition Modeling (FDM) involves extruding a thermoplastic material layer by layer to build the object. Stereolithography (SLA) uses a liquid resin that is solidified layer by layer using UV light. Digital Light Processing (DLP) is similar to SLA but uses a digital light projector for curing the resin. Selective Laser Sintering (SLS) utilizes a laser to fuse powdered material to create the object. The 3D printer follows the design specifications of the 3D print data 1522, layer by layer, to produce an accurate and detailed pessary.

[0197]

[0155] After printing, the 3D-printed pessary may undergo a quality control process. This involves examining the physical pessary to ensure that it matches the design parameters and is free of defects or inaccuracies.

[0156] In some alternative embodiments, a mold can be 3D printed based on the optimized pessary design of the 3D print data 1522, and the pessaries (or other gynecological prosthetic) can be cast using a biocompatible material, such as medical-grade silicone. This method is often used in traditional pessary production.

[0198]

[0157] In FIG. 16, an exemplary method of gynecological prosthetic customization 1600 is provided. The exemplary method can be performed by the computing device 510 by running computer program instructions retrieved from the computer readable medium 518 on the processor 516. Further, the method steps are performed by the corresponding software modules described with reference to FIG. 15. The following method 1600 is described with an object of custom designing a pessary. However, other gynecological prosthetics that could benefit from custom design with respect to the vaginal canal could be designed and manufactured. In some embodiments, the method 1600 applies to gynecological prosthetics that are dynamic, such as the gynecological prosthetics described herein in which applied pressure causes a reconfiguration of the prosthetic such as to expand (i.e. increase a spread) of the prosthetic. In some embodiments, the method 1600 is used to customize gynecological prosthetics which are configured to direct a force from a portion of a prosthetic body on which the pressure is incident to another portion of the prosthetic to cause an increase in a spread (e.g. width) of the gynecological prosthetic.

[0199]

[0158] In step 1610 of the method 1600, input data 1502 is acquired. That is, measurements obtained from a pelvic exam may be provided to the computing device 510 through a user interface 511 or through a user interface of an external device and transmitted over the network 502. In some embodiments, the measurements are obtained using measurement devices and methods described in WO2024 / 113063 published on 6 June 2024, the contents of which are herein incorporated in their entirety. In the input data acquisition step 1610, relevant patient-specific data is gathered including anatomical measurements of the patient's pelvic region, such as vaginal dimensions and anatomical markers, as well as Vaginal Tactile Imaging (VTI) results and parameters derived therefrom. Additionally, the patient's Body Mass Index (BMI) is received. Optionally, the type and stage of the patient's prolapse condition, along with any relevant medical history, are also received to initiate the customization process. These measurements, along with (or without) measurement results of a preclinical bone detection algorithm performed on a scan of the patient, are provided to describe the 3D dimensions and shape of the vaginal canal of the patient along with other characteristics indicating the stage and type of the prolapse. Various pressure indicative data may be included to support modelling of the pressure conditions to which the pessary is subject when placed in situ in the vaginal canal.

[0159] Any combination of the following parameters may be measured for the patient and provided to the computing device 510 as part of the input data acquisition step 1610: gh (Genital Hiatus), TvL (Total Vaginal Length), Aa (Anterior Wall), (Ba) (Anterior Prolapse Degree), Ap (Posterior Wall), Bp (Posterior Prolapse Degree), Pb (Perineal Body), D (Posterior Fornix), C (Cervix / Cuff), BMI (Body Mass Index), IAP / BMI (Intra-Abdominal Pressure (both transvaginal and transrectal)), IVP / BMI (Intravesical Pressure), IAP / BMI (Intra-Abdominal Pressure (Transvaginal)), Distance Between Ischial Spines, Distance Between Ischial Spines and Coccyx, Distance Between Ischial Spines and Pubic Symphysis, Anterior Fornix Distance, Posterior Fornix Distance, Cervical Size, and Width of vaginal canal.

[0200]

[0160] With reference to FIG. 10, an explanation of POP-Q parameters can be provided. Point Aa is at the midline of anterior vaginal wall. Where no prolapse is present this location is 3cm up from the hymen (merely interior to the vaginal opening). Parameters from the hymen can be -3cm indicating no anterior vaginal prolapse or +3cm, which is a full prolapse. Point Ba refers to the most distal portion of the remaining upper anterior side of the vaginal wall. This location coexists with Aa (-3cm) in a woman with no anterior prolapse. However, in a woman with full prolapse, this location coexists with point C. Its location can range from -3 to +6 or +7 in severe cases. Point C is the lowest edge of the cervix or the vaginal cuff (i.e. hysterectomy scar). This location identifies if the cervix is descending. Point D is the topmost point of the posterior vaginal wall. This location can be contrasted with Point C to assess if the entry to the cervix has been extended. Point Ap is located midline of posterior vaginal wall 3cm proximal to hymen. The parameters for this point can range from -3cm to +3cm relative to hymen. Point Bp refers to the most distal portion of the remaining upper posterior side of the vaginal wall. Its location can range from -3 to +6 or +7 in severe cases. Furthermore, three anatomical markers (GH, PB, TVL) can be examined: GH is the 'Genital hiatus' that records the length from the urethral opening to the posterior vaginal opening / hymen. The hiatus refers to the opening in puborectalis muscle, a component of the levator ani muscle group. A larger distance here may indicate laxity in this area. PB is the 'perineal body' and is recorded from the posterior aspect of hymen to the mid-anal opening. This will give an insight to the tonicity of superficial pelvic floor. Through vaginal birth the perineal body can be injured via tears or by an episiotomy. TVL refers to 'total vaginal length' measured from hymen to the most distal point. Knowing this allows the depth of prolapse to be assessed and reassessed post surgical repair.

[0201]

[0161] In one embodiment, a step 1620 of generating a 3D vaginal canal model is implemented. In an alternative embodiment, the patient data 1504 may be sufficient to describe the vaginal canal without generating a full model so that an optimally fitting and performing pessary is generated by the machine learning model or the FEA simulation using the patient data 1504 as an input rather than the 3D vaginal canal model. The patient data 1504 provided by the step 1610 of input data acquisition is imported into the vaginal canal model module 1506 so that vaginal canal dimensions and shape are defined. In order to generate a vaginal canal model for each patient, a predetermined shape of the vaginal canal may be used that has been segmented from literature and other patient’s Vaginal MRIs (e.g. prolapsed and healthy). This model is parametric and may be adapted to each patient’s values as defined by the patient data 1504 each time a customization is taking place. There are 3 values in Pop-q measurements which are anatomical markers, GH, Tvl, and Pb. These parameters may be added to the vaginal canal CAD model generated in step 1620. For example, the Tvl and GH values from the POP- Q measurements may be used to adjust the length and the size of the introitus of the vaginal canal model respectively. As an example, if the Tvl is 8cm the vaginal canal model may be changed to become 8cm and mimic the closest shape of the real patient vaginal canal. Also, other values from the POP-Q data such as Aa, Ap, Ba and Bp, C,D, etc will provide insight about the type and the stage and / or grade of each patient’s prolapse. Therefore, the CAD model can be adjusted to simulate those conditions. As another example, a width of vaginal canal provided in the patient data 1504 provides insight about the size and perimeter of the pessary being used and the vaginal canal model will be adapted based on that. In some embodiments, a predetermined shape of the vaginal canal is adapted based on various measurements included in the patient data 1504 to mimic the prolapse and the vaginal canal.

[0202]

[0162] In some embodiments, a predetermined shape of each kind of prolapse is provided as a reference model (which may be extracted from MRI measurements). The appropriate reference predetermined shape may be selected based on patient specific prolapse information. This reference model may then be adapted based on dimensional and shape information included in the patient data 1504 such as size parameters (width of different parts of vaginal canal and the TVL and gh measurements from POP-Q) to make the model an exact copy of a real patients vaginal canal as the model is parametric.

[0203]

[0163] Along with the shape of the vaginal canal, another factor in creating the model of the condition of the vaginal canal, is to include pressure data for the patient, e.g. a user specific pressure profile. In order to customize the pressure profile for each patient, the BMI value for the patient is transferred to pressure (including but not limited to intra abdominal pressure, intravaginal pressure, etc) in the model. BMI may also be translated to force and / or direction of force / pressure. BMI may be translated with the formula: IAP / BMI = 0.76(P*<0.0001) CmH2O to obtain the intra abdominal pressure (both transvaginal and transrectal). BMI may be translated with the formula: IVP / BMI= 0.71(P<0.0001) CmH2O to obtain the intervesical pressure. BMI may be translated with the formula: IAP / BMI = 0.73(P<0.0001) CmH2O to obtain the transvaginal pressure. This pressure profile (or different types of pressure estimation) is applied on the vaginal canal model generated as part of step 1620 to simulating the condition of the patient. The pressure indicative data may be applied to the vaginal canal model and / or included as part of the FEA simulation. Any pressure indicative data relating to the vaginal canal as described above may be used, whether derived from BMI or not.

[0204]

[0164] An alternative to performing step 1620 of generating the 3D vaginal canal model is to design a pessary outside the vaginal canal and use the patient measurements directly on the pessary model as constraints. That is, the vaginal canal dimension and shape information is incorporated directly into the pessary model. In this example, the vaginal canal model is not built. Instead, the anatomical measurements of each patient provided in the patient data 1504 are used to set dimensions of the pessary model (such as width of the different parts of the vaginal canal, distance of the ischial spines to each other and to Pubic Symphysis and Coccyx (to calculate the maximum expansion and resting points of the pessary), TVL (to calculate the height of the pessary) and Gh (to know the minimum dimensions of the pessary as well as the size of the pessary in order for it not to dislodge)). Pressure profile (previous VTI and the BMI translation) values along with their directions (extracting from the Aa, Ap, Ba, Bp, C and D) towards the pessary are used by the FEA simulation on the pessary alone. The same procedure of ML model optimization is performed. The output parameters of the simulation may be different and not include performance parameters describing an interaction between the pessary and the vaginal canal.

[0205]

[0165] In step 1630, a pessary model is provided. In a first iteration (where an iterative process is being used), some of the patient data 1504 is used to select a reference pessary design to be subsequently adapted. For example, the reference pessary design may be selected depending on the type of prolapse of the patient, the size of a previous pessary that the patient has already used and / or also depending on the measured parameters including, but not limited to, the width of the mid vaginal canal and / or other patient specific vaginal canal dimensions. The reference pessary model may be selected from multiple predetermined shapes for the pessary including initial dimensions of the pessary. In other embodiments, a random reference pessary design is selected from a plurality of reference pessary designs. The selected reference pessary design is adjusted and optimized by the ML model, possibly in an iterative process. The 3D pessary model may describe at least pessary height, dimensions, angles and fillet of the edges and the dynamic mechanism of the pessary. The reference pessary design may be topology optimized in subsequent steps by changing shape and size to become the most suitable design for the application based on the defined environment it is situated in according to the vaginal canal model or the patient data.

[0206]

[0166] In an indirect customization process embodiment, step 1640 is provided by which the performance of the pessary model is assessed using an FEA simulation. During an automated FEA simulation (or parametric simulation), FEA software (implemented by the FEA module 1510) places the 3D pessary model into the 3D vaginal canal model so that mechanical performance measurements such as displacements, reaction forces, safety factors, vector of reaction force, stress, strain, potential energy of the pessary, etc. can be explored and the values of these performance measurements are output by the FEA simulation in the form of pessary performance data 1516. Step 1640 models an interaction of the vaginal canal and the pessary including evaluating how pressure (provided in pressure indicative data) impacts the anchoring, displacement, load distribution, etc. of the pessary in the vaginal canal.

[0207]

[0167] In step 1650, pessary model adjustments are generated using the ML (Al) model. That is, the pessary performance data 1516 provided by the FEA simulation of step 1640 is input to the ML model along with the 3D pessary model and the 3D vaginal canal model. The ML model recommends adjusted pessary data 1520 by which changes are made to the pessary model to reduce a difference between a target pessary performance and a simulated pessary performance according to the FEA simulation. The adjusted pessary model generated in step 1650 is fed back to the FEA simulation in step 1640 in an iterative process 1660 until a convergence condition is satisfied such as optimum performance parameters for the pessary model (height, dimension, angles, etc) is found or sufficiently optimal performance parameters according to a threshold relative to respective target values.

[0208]

[0168] In alternative embodiments, a direct customization process is implemented in which the pessary model adjustments of step 1650 are generated directly by the ML model. In such embodiments, the FEA simulation of step 1640 is excluded, as is the iterative process step 1660. Instead, the ML model may generate the final pessary model in a single step. In the direct customization process, the ML model is trained to define a function between a variety of input value combinations for the pessary design (e.g. a range of possible input values) and resulting pessary performance for many different patients by using an FEA simulation during training. At run time, the ML model so trained is able to predict the optimum pessary design based on a range of input values for the pessary model. The range of input values may be clinician set or algorithmically set based on the patient data 1504 or the 3D vaginal canal model.

[0209]

[0169] Accordingly, method 1600 customizes the design of the pessary (including the dimensions, angles, and design features) utilizing a multi-dimension topology design optimization algorithm that incorporates a ML model. Design parameters for pessaries can vary across a range of variables, and effect the overall performance of the device in the vaginal canal. This produces a vast design space involving multiple combinations of design variables which will be time-consuming to independently study. The machine leaning algorithm is able to predict the best performing pessary for particular patients in order to streamline this process based on the 3D vaginal canal model and a pessary model as inputs.

[0210]

[0170] In step 1670, 3D print data 1522 is provided based on the adjusted pessary model resulting from step 1670. The 3D print data 1522 may be in the form of STL files or other digital data for a production phase. The 3D print data 1522 may be transferred to a 3D printing tool over the network 502 or by wired connection.

[0211]

[0171] In step 1680, the pessary is manufactured, such as by 3D printing, casting, or any other method. 3D printing can include DLP and SLA (direct printing). In other embodiments, 3D printing can include indirect printing which involves printing a shell or mold defining the pessary and subsequent casting of the pessary in the shell or mold. In yet other embodiments, the pessary and / or a mold of the pessary can be manufactured by one or more of casting, film processing, blow molding and overmolding.

[0212] Gynecological Prosthetic Installation

[0213]

[0172] Referring now to FIG. 13, shown is a schematic of an applicator 1300 for installing a gynecological prosthetic as disclosed herein. The applicator 1300 has a tubular body 1310 including a rounded opening 1320 with flaps, and a plunger 1330. Operation of the applicator 1200 will be described below with reference to FIG. 13, which is a flowchart of a method of installing a gynecological prosthetic. The applicator 1300 can be used with a wide variety of gynecological prosthetics, such as any of the gynecological prosthetics 200, 300 and 400 depicted and described herein.

[0214]

[0173] At step 1401 , with the plunger 1330 removed from the tubular body 1310, a gynecological prosthetic is loaded into the tubular body 1310. Patients and doctors can fold / collapse the gynecological prosthetic and put it into the applicator 1300 themselves. The gynecological prosthetic is in the compact state while inside the tubular body 1310. The plunger 1330 can then be re-inserted into the tubular body 1310. At step 1402, the applicator 1300 (with the gynecological prosthetic therein) is inserted into a vagina and moved into a suitable position within the vagina. Then, at step 1403, the gynecological prosthetic is released from the applicator 1300 by pushing plunger 1330 further into the tubular body 1310 thereby pushing the gynecological prosthetic out of the rounded opening 1320 and into the vagina. The gynecological prosthetic can be deployed by the applicator 1300 to automatically rest on the anchor points within the vagina based on geometry of the gynecological prosthetic.

[0215]

[0174] Also disclosed is a kit having a gynecological prosthetic as described and / or depicted herein, and an applicator as described and / or depicted herein. Both the applicator and the gynecological prosthetic can be multi-use for 2-years and 29+ days (disposable gynecological prosthetic) respectively. The gynecological prosthetic can also be made to have a shelf life of 2 years if it is not disposable.

[0216]

[0175] Numerous modifications and variations of the present disclosure are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the disclosure may be practised otherwise than as specifically described herein.

Claims

CLAIMS1. A method of custom designing a gynecological prosthetic for a patient, the method configured to be executed by at least one processor of a computer system, the method comprising: acquiring patient data pertaining to the patient, the patient data including data indicative of shape and / or dimensions of the patient’s vaginal canal into which the gynecological prosthetic will be disposed; acquiring a digital model of the gynecological prosthetic, the gynecological prosthetic having at least a portion configured to rest on one or more lateral walls of the vaginal canal of the patient; determining a customized digital model of the gynecological prosthetic by adapting the digital model of the gynecological prosthetic using the acquired patient data; and generating a digital file for manufacture of at least a portion of the gynecological prosthetic based on the customized digital model.

2. The method of claim 1 , wherein the gynecological prosthetic comprises a first portion and a second portion, wherein the gynecological prosthetic is configured to direct a force from the top portion to the bottom portion to cause an increase in a spread of the gynecological prosthetic.

3. The method of claim 1 or claim 2, wherein the gynecological prosthetic is configured to be deformable about at least one predetermined deformation point or at least one predetermined region.

4. The method of any of claims 1 -3, wherein at least a portion of the gynecological prosthetic is configured to flare outwardly responsive to the force.

5. The method of any of claims 1-4, wherein the gynecological prosthetic is configured so that a distance between first and second anchor members is expandable to anchor against opposed lateral walls of the vaginal canal.

6. The method of any of claims 1-5, wherein the gynecological prosthetic is configured so that load is distributed among a plurality of anchor members to lateral walls of the vaginal canal more than to posterior and anterior walls of the vaginal canal.

7. The method of any of claims 1-6, wherein the acquiring the digital model of the gynecological prosthetic comprises selecting from a plurality of reference digital models of different gynecological prosthetics.

8. The method of claim 7, wherein the selecting comprises a random selection.

9. The method of claim 7, wherein the selecting is based on the patient data.

10. The method of claim 9, wherein the selecting is based on geometric measurements of vaginal canal of the patient included in the patient data.

11. The method of any of claims 1-10, wherein the patient data includes pressure indicative data indicating pressure / force estimations or measurements.

12. The method of claim 11 , wherein the pressure indicative data comprises Body Mass Index (BMI) of the patient from which a pressure / force estimation is derivable.

13. The method of claim 11 , wherein the pressure indicative data includes vaginal tactile imaging data of the vaginal canal from which pressure / force estimations may be derived.

14. The method of any of claims 1-11 , wherein the patient data comprises Body Mass Index (BMI).

15. The method of any of claims 1-14, wherein the patient data comprises transvaginal intraabdominal pressure representing pressure exerted on the pessary through a vaginal wall of the patient.

16. The method of claim 15, comprising deriving the transvaginal intra-abdominal pressure from BMI of the patient.

17. The method of any of claims 1-16, wherein the patient data comprises intravesical pressure representing pressure within a bladder of the patient.

18. The method of claim 17, wherein the method further comprises deriving the intravesical pressure from BMI of the patient.

19. The method of any of claims 1-18, wherein the patient data comprises intra-abdominal pressure representing pressure within an abdominal cavity of the patient.

20. The method of claim 19, wherein the method further comprises deriving the intra- abdominal pressure from BMI of the patient.

21. The method of any of claims 1-20, wherein the patient data comprises one or pressure measurements of the vaginal canal of the patient.

22. The method of any of claims 1-21 , wherein the patient data comprises at least one or any combination of two or more of:BMI; abdominal pressure; intra-vaginal pressure; pressure from pelvic floor muscles (PFM); atmospheric pressure (AP); pressure from bladder towards vaginal canal; pressure from rectum towards vaginal canal; intra-abdominal pressure including both transvaginal and transrectal pressure; intravesical pressure; intra-abdominal pressure including transvaginal pressure; distance between ischial spines; distance between ischial spines and coccyx; distance between ischial spines and pubic symphysis; anterior fornix distance; posterior fornix distance; cervical size; a width of lower, mid and / or upper vaginal canal; and any one or more of the measurements within POP-Q measurements including one or more of Aa, Ba, Ap, Bp, D, C, Pb, Gh(width and length), tvl.

23. The method of any of claims 1-22, wherein the adapting the digital model of the gynecological prosthetic using the acquired patient data comprises simulating differentpressure profiles and assessing the physical reaction of the gynecological prosthetic in the vaginal canal according to the patient data.

24. The method of claim 23, wherein the physical reaction of the gynecological prosthetic that is assessed is one or more of a displacement of the gynecological prosthetic relative to a reference position, a deformation of the gynecological prosthetic, a force / pressure distribution within the gynecological prosthetic.

25. The method of claim 23, further comprising optimizing the geometry and / or material of the gynecological prosthetic based on the determined physical reaction, and a target physical reaction.

26. The method of claim 25, wherein optimizing the geometry of the gynecological prosthetic comprises one or more of adapting dimensions of the gynecological prosthetic to custom fit a periphery of the vaginal canal, adapting a relative angle of the spaced first and second portions that are spaced from each other along the vaginal canal.

27. The method of claim 25, wherein the optimizing comprises: iteratively, providing an output of the simulation to a machine learning algorithm as an input, and obtaining a new target physical reaction as an output from the MLA, and inputting the new target physical reaction into the simulation.

28. The method of claim 27, wherein the simulation is a finite element analysis simulation.

29. The method of any of claims 1 -28, wherein adapting the digital model of the gynecological prosthetic comprises performing a simulation of the gynecological prosthetic based on the patient data describing the vaginal canal to provide performance data; and providing the performance data to a machine learning model to determine adjustments to the digital model aiming to reduce a difference between target performance and performance predicted by the simulation to thereby provide an adjusted digital model of the gynecological prosthetic; and feeding the adjusted digital model back to the simulation in an iterative process of simulation and determining adjustments by the machine learning model.

30. The method of claim 29, wherein the simulation is a finite element analysis simulation.

31. The method of claim 29, wherein the iterative process continues until a convergence condition is fulfilled.

32. The method of claim 29, wherein the performance data includes one or any combination of:displacement of the gynecological prosthetic within the vaginal canal; reaction forces exerted on the gynecological prosthetic; safety factors including stability of the gynecological prosthetic within the vaginal canal; stress and strain distribution for the gynecological prosthetic; deformation of the gynecological prosthetic under different loads; force / pressure distribution within the gynecological prosthetic and its contact points with the vaginal canal; gynecological prosthetic movement and rotation within the vaginal canal; and dynamic or static behavior under dynamic or static conditions.

33. The method of claim 31 , wherein the convergence condition includes the adjusted physical model being insufficiently different to that of a previous iteration or the performance prediction being insufficiently different to that of a previous iteration.

34. The method of claim 29, wherein a first iteration of the iterative process is performed on a reference digital model of the gynecological prosthetic that has been randomly selected or selected based on a closest match with one or more geometric parameters of the vaginal canal included in the patient data.

35. The method of any of claims 1 -34, wherein adapting the digital model of the gynecological prosthetic comprises providing a range for each of a variety of adjustable parameters of the digital model as an input to a machine learning model that has been trained based on combinations of adjustable parameters of the digital model and resulting performance data generated by a Finite Element Analysis simulation of the digital model relative to the patient data, the machine learning model generating an adjusted digital model of the gynecological prosthetic configured to achieve target performance.

36. The method of any of claims 1-35, comprising generating a 3D vaginal canal model based on the patient data.

37. The method of claim 36, wherein generating the 3D vaginal canal model comprises retrieving a reference vaginal canal model and adapting the reference vaginal canal model based on the patient data.

38. The method of claim 36, comprising performing a simulation of the digital model of the gynecological prosthetic, which is a 3D digital model, in place in the 3D vaginal canal model to generate performance data, wherein the performance data is utilized to adjust the digital model of the gynecological prosthetic.

39. The method of any of claims 1-38, comprising generating the digital model of the gynecological prosthetic based on the patient data including geometric information of the vaginal canal of the patient.

40. The method of claim 39, comprising performing a simulation on the digital model to determine performance data.

41. The method of claim 40, wherein the performance data includes one or any combination of: pressure distribution within the gynecological prosthetic, stress and strain within the gynecological prosthetic, deformation of the gynecological prosthetic under different loads, and force distribution about the distribution of forces or pressures acting on the gynecological prosthetic.

42. The method of any of claims 1-41 , comprising manufacturing the gynecological prosthetic based on the digital file.

43. The method of Claim 42, wherein the manufacturing comprises 3D printing based on the digital file.

44. The method of claim 42, wherein the manufacturing comprises 3D printing a cast based on the digital file and molding the gynecological prosthetic.

45. The method of claim 36 or claim 37, further comprising manufacturing a physical model of the 3D vaginal canal model and using the physical model of the 3D vaginal canal model to physically evaluate a physical model of the gynecological prosthetic.

46. A non-transitory computer readable medium having recorded thereon instructions that, when executed by a processor of a computing device, configure a processor to implement a method according to any of the preceding claims.

47. A computing device, comprising: a processor; anda non-transitory computer readable medium having recorded instructions that, when executed by the processor, configure the processor to implement a method according to any of the preceding claims.

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