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EP-4742269-A2 - METHODS AND SYSTEMS FOR VAGINAL THERAPEUTIC DEVICE FITTING

EP4742269A2EP 4742269 A2EP4742269 A2EP 4742269A2EP-4742269-A2

Abstract

A variety of medical and non-medical devices are exploited by users to address a wide range of conditions. However, in the vast majority of instances the device has a limited number of options with respect to its fit for the user and its performance. Further, the determination of target performance and fit are established on a qualitative basis rather than a quantitative basis. In many instances these combinations lead to low user acceptance of the device due to the resulting performance and fit issues. Accordingly, it would enhance performance and user acceptance if a quantitative determination provided a recommended type where options exist, and this determination provided the basis of a custom designed device to the user's specific anatomical and/or performance requirements.

Inventors

  • SHAM, Derek

Assignees

  • COSM Medical Corp.

Dates

Publication Date
20260513
Application Date
20180918

Claims (15)

  1. A method of providing a customized vaginal therapeutic device, VTD for a user comprising: receiving user-specific data characterizing one or more anatomical measurements of a user's anatomy; generating a model based on the received user-specific data, the model including one or more anatomical features of the user; designing the customized VTD based on the generated model, the customized VTD having a defined geometry and a defined material composition to treat at least one ailment of the user; and providing data characterizing the defined geometry and the defined material composition of the designed customized VTD.
  2. The method of claim 1, wherein the model is generated at least in part with a computational model or algorithm; and optionally, wherein the computational model or algorithm comprises a machine-learning algorithm and/or an artificial intelligence engine.
  3. The method of claim 1, wherein the provided data comprises a CAD file containing a virtual three-dimensional model of the designed second VTD.
  4. The method of claim 1, wherein the one or more anatomical measurements include data derived from a clinical assessment.
  5. The method of claim 4, wherein the clinical assessment comprises a Pelvic Organs Prolapse Quantification (POP-Q).
  6. The method of claim 1, wherein the one or more anatomical measurements include ultrasoundderived data.
  7. The method of claim 1, wherein the defined geometry and the defined material composition include at least one biometric sensor.
  8. The method of claim 1, further comprising fabricating the customized VTD according to the defined geometry and defined material composition; and optionally, wherein the fabricating is accomplished via at least one additive manufacturing technique or wherein the fabricating is accomplished via at least one non-additive manufacturing technique.
  9. The method of claim 1, wherein the user-specific data includes user quality-of-life information characterizing; and optionally, wherein the user quality-of-life information includes one or more performance goals of the user.
  10. A method of providing a customized vaginal therapeutic device, VTD, for a user comprising: receiving user-specific data including clinical information characterizing user response information for a first VTD designed to treat a first user ailment; updating at least one model based on the user-specific data; designing a second VTD based on the updated at least one model, the second VTD having a defined geometry and a defined material composition designed to treat the first user ailment; and providing data characterizing the defined geometry and the defined material composition of the designed second VTD; wherein the defined geometry and/or the defined material composition of the designed second VTD is different than a corresponding geometry and/or material composition of the first VTD.
  11. The method of claim 100, wherein the clinical information comprises one or more of professional assessment information and quality-of-life information.
  12. The method of claim 100, wherein the user quality-of-life information includes symptoms related to the first user ailment while the first VTD is worn by the user.
  13. The method of claim 100, wherein the user quality-of-life information includes one or more performance goals of the user.
  14. The method of claim 100, further comprising fabricating the customized VTD according to the defined geometry and defined material composition; and optionally, wherein the fabricating is accomplished via at least one additive manufacturing technique or wherein the fabricating is accomplished via at least one non-additive manufacturing technique.
  15. The method of claim 10, wherein the provided data comprises a CAD file containing a virtual three-dimensional model of the designed second VTD.

Description

FIELD OF THE INVENTION The present invention relates to vaginal therapeutic devices and more methods and systems for establishing a custom fitting or an enhanced fitting of such vaginal therapeutic devices. BACKGROUND OF THE INVENTION For women within these medical conditions pelvic organ prolapse (POP) and urinary incontinence (UI) are common and often distressing conditions. Research indicates that in the United States alone there are 3.3 million women with pelvic organ prolapse and approximately 300,000 surgeries are performed annually in the United States. Additionally, between approximately 25% of all women, 33% of older women, have some degree of urinary incontinence. Further, male urinary incontinence whilst it exists has only recently become perhaps evident to the general population with the advent of advertisements for male and female incontinence underwear. An aging population at this point would not indicate any reduction in such figures in the near term whilst a massive expenditure and ease of availability of ultra-thin liners for women's underwear, male and female incontinence underwear and emerging products such as liners for male underwear within supermarkets and pharmacies indicate that the demand and market are high enough for multinational household product and pharmaceutical enterprises to have product lines and brands in this area. As a result, POP studies frequently have prominent numbers of women over the age of 50 and Caucasian, rather than including young women who have given birth and a more diverse balance of women from multiple races and nationalities. Accurate data related to occurrence and impact of POP will be more readily attainable after POP becomes common knowledge and as studies related to POP are now beginning to become more widespread. Today, it is not uncommon for women to not disclose indicators of POP to physicians because of embarrassment related to the symptoms. POP encompasses the widest demographic of all women's health issues and the dynamics behind POP are likely to be more diverse than any other health condition women will experience. Multiple types of POP display a variety of symptoms; women's unique childbirth, occupation, genetics, general health, and social activities history vary significantly, and the demographic variables are diverse. There are a range of surgical treatment options for POP as well as non-surgical treatments. Non-surgical treatment options include Kegel exercises, Kegel assist devices, pessaries, core/floor strengthening exercises, biofeedback, electrical stimulation, hormone replacement therapy, tibial nerve stimulation and support garments. However, despite the wide demographic, the multiple types of POP, and the uniqueness of every woman the non-surgical solutions available such as Kegel assist devices and pessaries etc. are fitted today by best guess, trial-and-error, or incorrectly. The Internet is replete with articles either explaining to medical personnel how to fit a pessary or explaining to users how to tell if their pessary fits correctly. Whilst manufacturers understand the need for a range of sizes the result is a plethora of types and sizes for the medical personnel to select from and employ. For example, the "Folding Smith" pessary design is available in 10 standard sizes as outlined below in Table 1. Repeat such a number of options for each different pessary design and the result is a logistical nightmare for a medical facility offering fitting of pessaries, a bewildering number of options with different characteristics per design, and either lots of trial-and-error to achieve a successful outcome or more likely a series of fittings and a patient stopping from frustration. Even amongst the medical profession, most clinicians tend to view the pessary with a mixture of reluctance and disregard. Against this study data indicates that approximately 90% of patients can be successfully treated with a non-pharmaceutical and/or non-surgical solution that has very few contraindications. Table 1: Exemplary Size Options for Folding Smith PessarySizeLength (inch)Width (inch)03 ⅛213 ¼2 ⅛23 ½2 ¼33 ¾2 ⅜44 ¼2 ½54 ½2 ⅝64 ¾2 ¾752 ⅞85 ½395 ¾3 ⅛ Accordingly, it would be beneficial to provide medical personnel with a quantitative rather than a qualitative basis for the determination of the size of a pessary vaginal therapeutic device (VTD), or other VTD. It would be further beneficial for the quantitative based determination to provide a recommended type where multiple types are options. It would be further beneficial for the quantitative based determination to provide the basis of a custom designed pessary VTD or other VTD to the user's specific anatomical requirements and/or POP/UI characteristics. It would also be evident that a variety of user specific therapeutic devices (USTDs) such as orthotics and orthopedics exhibit similar issues in respect of them benefitting from the application of a design and simulation process exploiting user spe