Vaginal Rehabilitation Dilator After Pelvic Radiotherapy and Brachytherapy

Abstract

The invention relates to medical devices, biomaterial technologies, women's health, and rehabilitation techniques after oncological treatment. It concerns vaginal dilator systems developed for the rehabilitation of fibrosis, loss of elasticity, vaginal stenosis, and associated functional limitations that may develop after pelvic radiotherapy and / or brachytherapy. The system will be used to reduce cervicovaginal tissue changes caused by radiotherapy, preserve vaginal patency, and facilitate clinical examination and recurrence monitoring.

Description

VAGINAL IMPACT AFTER PELVIC RADIOTHERAPY AND BRACHYTHERAPY REHABILITATION DILATOR TECHNICAL FIELD The invention relates to medical devices, biomaterial technologies, women's health, and oncology. This relates to post-treatment rehabilitation techniques, including pelvic radiotherapy and / or Fibrosis, loss of elasticity, vaginal stenosis, and other complications can develop after brachytherapy. vaginal developed for use in the rehabilitation of associated functional limitations. This is related to dilator systems. The system in question is used to treat cervicovaginal tissue dilation caused by radiotherapy. minimizing changes, preserving vaginal patency, clinical examination and recurrence It will be used to facilitate tracking. PREVIOUS TECHNIQUE Gynecological cancers include cancers of the cervix, endometrium, ovaries, vagina, and vulva. a heterogeneous disease encompassing malignancies of the female reproductive system This is a group of diseases that have clinical, psychosocial, reproductive, and other impacts on women's health. It constitutes a multifaceted and high-level burden encompassing dimensions of quality of life. According to global cancer statistics, cervical cancer will cause approximately 661,000 new cases in 2022. With 348,000 cases and 348,000 deaths, it is among the most common cancers in women; The mortality burden is particularly increasing in low- and middle-income countries. Treatment of gynecological cancers includes surgery, radiotherapy, chemotherapy, and brachytherapy. Multimodal approaches, including those involving multiple methods, are among the standard treatment methods. In particular, pelvic radiotherapy and brachytherapy applications provide local tumor control and While offering significant advantages in terms of survival, radiation-induced fibrosis, pathophysiological effects include microvascular damage, epithelial thinning, and loss of elasticity. This can cause changes. As a result of these changes, vaginal problems may develop. Stenosis; vaginal narrowing, dryness, dyspareunia, sexual dysfunction, and penetration. This can lead to complications such as difficulty in quality of life for patients and gynecological problems. This can negatively affect monitoring processes. Narrowing of the vaginal opening and tissue Decreased elasticity can make gynecological examinations and follow-up for recurrence more difficult; some It can cause irritation, microtrauma, and an increased risk of infection in patients. Additionally, painful experiences and challenging examination processes can lead to anxiety and avoidance behavior. and is associated with decreased adherence to rehabilitation practices. Clinical 1 In practice, this is the most commonly recommended approach for the prevention and management of vaginal stenosis. The use of vaginal dilators is recommended after radiotherapy according to international guidelines. Dilators should be used 2-3 times a week, for 5-10 minutes each time, and for at least... It is recommended to continue for 6–12 months. Current vaginal dilators are generally manufactured in standard sizes and firmness levels, individual development of cervicovaginal tissue problems after radiotherapy and brachytherapy adequately considering sensitivities, anatomical changes and biological tissue responses They do not include it. These products mostly only have a mechanical expansion function. focusing on post-radiation fibrosis, loss of elasticity, tissue a fragile, adaptable form that responds to pathophysiological changes such as dryness and sensitivity It does not offer a structural solution. Therefore, existing options are made from rigid or semi-rigid materials. The use of dilators can cause pain, discomfort, microtrauma, and sensitivity in vaginal tissues. This can lead to issues such as denial of use. Vaginal dilators used in current practices mostly require gradual adjustment. behavior that does not provide, depending on the temperature, sensitivity and elasticity of the tissue. They have structures that do not change. This situation affects tissue after radiotherapy and brachytherapy. In patients with reduced tolerance, the dilation process becomes more difficult and rehabilitation becomes more challenging. This leads to a disruption of continuity. Furthermore, existing products, for the user... providing systematic usage guidance, making the application process more controlled and clinical efficacy and patient care are affected because it does not offer a sustainable usage approach. It remains limited in terms of its softness. Radiotherapy and brachytherapy applied to the pelvic region target the tumor. It affects not only the cellular tissue but also the surrounding healthy cervicovaginal tissues. It causes damage at this level. Ionizing radiation damages the double helix of cellular DNA. It causes fractures, suppresses epithelial cell renewal, and inhibits tissue regeneration. This reduces its capacity. This process occurs in the vaginal epithelium, which has a rapid regeneration capacity. It leads to a disruption of physiological integrity after radiation exposure. epithelial thinning in the vaginal mucosa, decreased glandular secretion, and changes in vascular structures. Narrowing occurs. Tissue constriction results from impaired capillary circulation. Oxygenation decreases and irregular accumulation develops in collagen fibers. This situation Over time, vaginal atrophy, dryness, loss of elasticity, and tissue fragility may occur. It concludes. Activation of chronic inflammatory response after pelvic irradiation and Increased fibroblast proliferation leads to fibrotic changes in cervicovaginal tissues. 2 This prepares the ground for its development. Increased collagen synthesis and decreased elastin production. This results in hardening of the vaginal walls, narrowing of the lumen, and progressive stenosis. This can occur. Developing atrophy and fibrosis lead to decreased vaginal elasticity. sexual dysfunction, dyspareunia, and difficulties during gynecological examinations Vaginal narrowing and shortening negatively affect the quality of life of patients. and makes regular follow-up and examination processes more difficult. Therefore, long term Cervicovaginal rehabilitation is an important clinical need in cancer survivors. This is how it appears. Pathophysiological and pathological changes that develop as a result of radiotherapy are spontaneous. These are processes with limited potential for recovery. Appropriate rehabilitation approaches... In its absence, atrophy, fibrosis, and stenosis can progress. This Therefore, it is compatible with cervicovaginal tissues, reduces the risk of trauma, and protects the patient. taking into account the level of sensitivity and gradual expansion within physiological limits. Supportive vaginal dilator systems are needed. THE PURPOSE OF THE INVENTION The aim of the invention is to provide guidance after radiotherapy, brachytherapy, and pelvic floor irradiation. Fibrosis, loss of elasticity, and stenosis can develop in sensitized cervicovaginal tissues. tissue compatibility for the prevention and rehabilitation of functional limitations. The aim is to offer an enhanced vaginal dilator system with reduced risk of trauma. The vaginal dilator system developed within the scope of this invention features an elastic body structure and Thanks to its thermosensitive hydrogel-coated surface designed to reduce trauma, it protects against radiation. a more compatible contact surface with sensitized cervicovaginal tissues It is formed by a thermosensitive hydrogel coating that partially dissolves when it comes into contact with body heat. softening and thus reducing the formation on the cervicovaginal tissues during application. It contributes to reducing mechanical pressure. This structure improves patient comfort. improved usability compared to standard rigid or semi-rigid dilators. is supported and the rehabilitation process is carried out in a more sustainable way. that is intended. Another aim of the invention is to consider the patient's anatomical structure, tissue sensitivity, and tolerance. a gradual and controlled approach, taking into account the level, treatment phase and clinical requirements The aim is to offer a rehabilitation approach. Within this scope, the vaginal dilator system is used for small to medium-sized vaginal dilators. The fact that it can be produced in different sizes, including large ones, ensures that the dilation process is beneficial to the patient. It allows for gradual progress, starting from an appropriate size. 3 Thus, accustoming the cervicovaginal tissues to expansion within physiological limits reduces pain. The aim is to reduce discomfort and increase patient compliance. The invention also includes dilator variants with a thermosensitive hydrogel-coated surface. alongside, there is also a fixed-surface dilator option that does not have thermosensitive properties. It is designed as a system. This allows different patient groups to accommodate different sensitivities. alternative application options for different levels and clinical use scenarios This structure provides a more efficient alternative to existing single-size and single-type dilators. It offers a flexible, controlled, and individualized usage approach. In these respects, the invention addresses cervicovaginal problems after radiotherapy and brachytherapy. Increasing tissue adaptation during the rehabilitation process, reducing the risk of mechanical trauma, supporting patient comfort and contributing to long-term continuity of use It aims to offer a patient-centered vaginal dilator system. DETAILED DESCRIPTION OF THE INVENTION The invention takes into account the patient's individual needs, anatomical structure, and tissue. to adapt to its sensitivity and the different phases of the rehabilitation process It is designed as a system consisting of multiple vaginal dilators. The aforementioned The vaginal dilator system comes in three thermosensitive hydrogel-coated tubes in small, medium, and large sizes. along with the dilator, it has a constant surface hardness and thermosensitive softening properties. It is presented in a package containing one dilator, which is not present in this invention. thermosensitive hydrogel coating used; temperature-sensitive phase transition behavior Poloxamer 407 and Poloxamer 188 based hydrogel formulation capable of demonstrating It contains Poloxamer 407 and Poloxamer 188, poly(ethylene oxide)-poly(propylene oxide)- They are nonionic triblock copolymers with a poly(ethylene oxide) (PEO-PPO-PEO) structure. It is used in the creation of biocompatible thermosensitive hydrogel systems. The hydrogel structure contains a water-based polymeric network system that is warm to human body temperature. formulated to exhibit physical property changes within the range, preferably 35–37°C. The hydrogel coating in question provides a controlled surface within the specified temperature range. It softens and gels upon contact with the vaginal mucosa. It helps to reduce friction and increase surface slipperiness. The main body of the dilator is made of biocompatible latex, suitable for vaginal mucosal contact. medical-grade silicone elastomer that does not contain and exhibits elastic deformation properties. It is manufactured from this material. The silicone elastomer structure used allows for application during the process. By providing controlled flexibility, it helps to reduce the effect of rigid pressure. 4 Comparative standard dilator materials exhibit temperature-dependent physical softening. exhibiting non-reactive behavior, maintaining constant surface hardness properties, and lacking thermosensitive properties. It consists of medical polymer-based materials that do not contain [substances]. Materials include polyethylene (PE), polypropylene (PP), polycarbonate (PC), or rigid medical grade polycarbonate. It includes plastic derivatives. The surface hardness of these materials corresponds to the Shore D hardness scale. It is defined according to and exhibits significant elasticity within the human body temperature range (36–38°C). It does not exhibit any increase, surface softening, or gelling behavior. In contrast, this The thermosensitive hydrogel coating used in the invention is controlled by the effect of body temperature. By providing surface adaptation, it reduces mucosal irritation and vaginal irritation. It allows for increased tolerability of use in rehabilitation applications. This behavior exhibited by the hydrogel coating affects the tissue during application. It contributes to reducing the mechanical stress transmitted to the surface and is beneficial during radiotherapy or After brachytherapy, sensitized, atrophied, and trauma-prone tissues are left behind. This creates a more balanced and harmonious contact environment. This allows for expansion. the process is carried out in a more comfortable and easily tolerated way, same supporting the continuity of use during the rehabilitation process over time This is the aim. Thanks to this structure, the system can be used for radiotherapy, brachytherapy, and pelvic floor therapy. Sensitivity and loss of elasticity that may develop in cervicovaginal tissues after irradiation. In the rehabilitation of loss, stenosis and functional limitations, gradual, controlled and It can provide patient-centered use. The invention includes thermosensitive devices offered in small, medium and large sizes. Hydrogel-coated dilators allow for a gradual approach to the rehabilitation process. This provides an opportunity. During the usage process, the patient's anatomical structure, tissue sensitivity, appropriate size taking into account the post-treatment recovery phase and clinical tolerance level A dilator can be used, and a controlled transition to larger sizes is possible if needed. This is possible. Thanks to this structure, the physiological limits of cervicovaginal tissues can be maintained. accustoming it to expansion inside, functional impairment due to narrowing and loss of elasticity. The aim is to reduce limitations and increase patient compliance. The invention includes a fixed-surface dilator that does not have thermosensitive properties. however, depending on clinical requirements, patient tolerance, or application preference It offers an alternative usage option. This dilator, due to its hydrogel coating... It is a structure that does not exhibit softening behavior and maintains a constant surface hardness. Thus The system is not limited to thermosensitive hydrogel-coated variants only, but also includes different A complementary dilator option that can be used in rehabilitation scenarios It includes. In this respect, the invention is unique among existing inventions that have a single dimension and a uniform surface structure. A more individualizable system compared to dilators, and more adaptable to clinical needs. It reveals. The invention includes thermosensitive hydrogel-coated elastic vaginal dilators; Available in small, medium, and large sizes, approximately 2×8 cm, 2.5×10 cm, and 3×12 cm. They can be designed in various sizes. The total length of the small size dilator is approximately 80. mm, with a maximum outer diameter of approximately 20 mm and a hydrogel coating exhibiting active softening. The length of the dilator region can be approximately 40–50 mm. In a medium-sized dilator... Total length approximately 100 mm, maximum outer diameter approximately 25 mm, and active hydrogel. The length of the covered area can be designed to be approximately 50–60 mm. Large In the case of a dilator, the total length is approximately 120 mm, and the maximum outer diameter is approximately 30 mm. and the length of the hydrogel-coated area showing active softening is approximately 60–70 mm. It can be within this range. Common to all sizes, the dilator consists of an elastic inner body structure with a base layered on top of it. from the applied thermosensitive hydrogel coating approximately 1–2 mm thick This can occur. The hydrogel coating in question is located on the active surface that comes into contact with the tissue. By providing temperature-dependent controlled softening and moisture retention behavior, it reduces friction. While contributing to reduction, the elastic inner body structure of the dilator's mechanical properties It ensures the preservation of its integrity and form stability. Thus, the elastic inner The body and thermosensitive hydrogel coating work together to provide both mechanical support. an integrated system that provides both functional and mucosal tissue-compatible surface behavior. It forms a dilator structure. 6

Claims

1. The patient's individual needs, anatomical structure, tissue sensitivity, and to adapt to different phases of the rehabilitation process It is a structured vaginal dilator system, the feature of which is; - with three thermosensitive hydrogel-coated dilators, having a constant surface hardness. and one dilator that does not have thermosensitive softening properties, - each of these thermosensitive hydrogel-coated vaginal dilators has a vaginal... Suitable for mucosal contact, biocompatible, latex-free, and elastic. made of medical-grade silicone elastomer material that exhibits deformation properties with an elastic inner body structure manufactured with the aforementioned elastic inner body structure It consists of a thermosensitive hydrogel coating applied to it. It is characteristic.

2. A dilator system conforming to Claim 1, characterized by its temperature-sensitive phase transition. a water-based polymeric network structure capable of exhibiting the same behavior as human body temperature Controlled surface softening and gelling behavior at 35–37°C. demonstrating, reducing the friction force during contact with the vaginal mucosa, increasing surface lubrication, reducing mucosal irritation and tissue in contact with tissue in order to reduce the mechanical pressure transmitted to its surface Temperature-dependent controlled surface adaptation and moisture retention on the active surface. In order to provide this behavior, poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene Poloxamer containing nonionic triblock copolymer in oxide (PEO-PPO-PEO) structure Three dilators containing thermosensitive hydrogel coatings based on 407 and Poloxamer 188. It is characterized by its inclusion. 7