A multifunctional Leipzig applicator for the detection and treatment of potential tumors on body surfaces with varying topological characteristics.

Abstract

The invention relates to a Leipzig applicator (1) that can easily adapt to different topological surfaces and is used in particular for the treatment and detection of skin cancers, such as skin cancer. Thanks to its special structural features, the applicator (1) can easily adapt to any area and topology, including indented and protruding surfaces. This adaptability allows the applicator to reach cancer lesions located in irregular areas on the skin directly and effectively. In addition, thanks to the perfect fit, it provides a seal in the area in contact with the cancerous tissue, allowing the radioactive rays to penetrate the desired area in a controlled manner without any leakage. These features enhance the therapeutic effect of the Leipzig applicator (11) by applying radiation directly to the targeted cancerous cells without damaging the surrounding tissues.

Description

1 TARIFF POTENTIAL ON BODY SURFACES WITH DIFFERENT TOPOLOGICAL PROPERTIES A MULTIFUNCTIONAL LEIPZIG FOR THE DETECTION AND TREATMENT OF TUMOR. APPLICATOR Technical Area The invention could be used in the treatment of many types of cancer, especially skin cancer. It relates to a Leipzig applicator developed for use in applied brachytherapy. This applicator is designed for use on uneven (protruding) surfaces such as hands, face, and spine. It has a structure that also adapts to the topological feature, and thus the treatment 10 It prevents radiation leaks that occur during the process. State of the Art Cancer occurs when cells in the body grow and multiply uncontrollably. This is a serious group of diseases that develop. Normal cells divide according to a specific cycle and produce 15... They eventually die; however, cancer cells disrupt this order and behave abnormally. It grows and multiplies, damaging surrounding tissues. There are many types of cancer. They are available; each with its own unique characteristics targeting different parts of the body. and has mechanisms. For example, breast cancer begins in breast tissue, Lung cancer affects the respiratory system. Brain cancer affects the central nervous system. While other cancers affect blood cells, leukemia targets blood cells. Skin cancers, such as melanoma, develop on the skin. Cancers, on the other hand, originate in skin cells. These different types affect the affected area. It can manifest with different symptoms depending on the individual, and therefore treatment methods also vary. is doing. Skin cancer is the development of malignant (cancerous) cells in skin cells. It is a type of cancer characterized by its growth. The most common types of skin cancer These are basal cell carcinoma, squamous cell carcinoma, and melanoma. Basal and squamous While cellular cancers usually develop in the upper layers of the skin (epidermis), melanoma In deeper layers, melanocytes, which produce the melanin pigment, emerge. 30 Skin cancer most commonly occurs on areas more exposed to the sun, such as the face, neck, hands, and arms. It is seen in the remaining areas. Visually, skin cancer lesions, discoloration, It can manifest as swelling, bleeding, or ulcer-like lesions, and especially 2 Melanoma appears as dark moles with asymmetrical, irregular borders. This is becoming apparent. According to the World Health Organization, approximately 2-3 million basal and 132,000 cases of squamous cell carcinoma and 132,000 cases of melanoma are reported. Treatment Treatment methods vary depending on the type, stage, and spread of cancer; surgical excision, radiotherapy (such as brachytherapy), cryotherapy (freezing), immunotherapy 5 And targeted therapies are frequently used methods in the treatment of skin cancer. It is among them. High-dose rate (HDR) brachytherapy is commonly used in the treatment of skin cancer. It is a system that, during treatment, delivers a radioactive source (usually Iridium-192) to the tumor 10 It is directed directly to the region. The Leipzig applicators used in this system, Especially in tumors close to the skin surface, the radioactive source must be in the correct position. It ensures that the radiation is contained and effectively delivered to the targeted area. This method makes it possible to deliver radiation only to the cancerous area. By enabling its implementation, it helps to protect the surrounding tissues, short 15 By reducing the treatment duration and applying high doses, it increases patient comfort and reduces tumor... It effectively targets the cells. However, the use of Leipzig applicators... There may be limitations depending on the size and shape of the tumor; irregular or large. It can be difficult to cover the entire tumor in lesions. The applicator must be correct. Placement and securing require experience, and the applicator comes into contact with the skin for 20 minutes. The implanted part is unable to adapt to the treated area. This lack of adaptation can lead to certain problems. In some cases, it causes radiation leakage, while in others, the treatment is not effective at all. This prevents its implementation. In the known state of the technique, Perez-Calatayud and colleagues at Leipzig 25 There is a study on applicators [1]. In this study, skin cancer Dose distribution of Leipzig applicators used in treatment, Monte Carlo (MC) method It is evaluated with these. These applicators, integrated into the HDR system, are superficial. This makes it possible to treat tumors with high-dose rate (HDR) brachytherapy. In this study, six different applicators with diameters of 1, 2, and 3 cm were analyzed; these applicators contained 30 The radioactive source should be positioned parallel or perpendicular to the treatment surface. It can be installed. Simulation results obtained using the MC method show PMMA. This was confirmed by experimental measurements made in the phantom, thus the dose rates Its reliability and sensitivity have been confirmed. Dose distributions are close to the tumor surface. 3 It offers a suitable structure for high-dose applications, while the dose in deeper regions... A decrease has been observed. The advantages of the Leipzig applicators mentioned in this study. their ability to deliver high doses of radiation to a limited area and to affect surrounding tissues While ensuring minimal impact can be considered, these applicators... There are significant disadvantages. Especially if the tumor is irregular or large. 5 In this case, inconsistencies in dose distribution may occur, affecting the entire tumor. Coverage can become difficult. Also, during application, the area being applied by the applicator may become problematic. Inability to adapt to the region (especially hilly areas) negatively affects treatment effectiveness. This affects and causes leaks. The compatibility of the applicators with the surface contact is crucial. In cases where it is insufficient, dose rates may be reduced, and this situation 10 This can jeopardize clinical outcomes. Patent number TR 2019 / 21282, which is included in the prior art. This relates to the brachytherapy applicator. This applicator is used in surgery for medical reasons. 15 used in brachytherapy treatment of patients diagnosed with incurable endometrial cancer It has been developed for this purpose. This applicator is inserted into the vagina and uterus to deliver high doses. It is designed to deliver radiation. It can be implanted as a single piece and is used for treatment. The fact that it has a 3-channel system that can be opened during the treatment process benefits both the patient and the patient. It increases comfort and also makes the job easier for healthcare professionals. Tandem (allowing the passage of radioactive sources inside) and cylindrical structures at various angles 20 It can be positioned and this feature can be adapted to the patient's anatomy and the tumor region. It allows for homogeneous dose distribution. However, the applicator must be applied to all patients. Further size and angle options to perfectly match their anatomy. The need for expansion stands out. Furthermore, despite being installed as a single piece... Positioning difficulties may be encountered during application; this is 25 This highlights the need for a more flexible and user-friendly design. The limitations and inadequacies of the solutions in the current technology, in the known state of the technology... The rough and protruding structure commonly found in Leipzig applicators The inability to perfectly fit surfaces means these applicators can cause radiation leakage. 30 and these leaks disrupt treatment and affect the patient and healthcare. due to reasons such as the exposure of employees to radiation leaks in this field An improvement is needed. 4 Brief Description and Objectives of the Invention The invention features a Leipzig design that adapts to different topological surfaces during application. The applicator is described. This applicator is used for types of cancer such as skin cancer. in the treatment and detection of tumors (determining parameters such as depth, width, etc.) It uses. Thanks to the structure of the applicator that is the subject of the invention, it has an indented-5 adapting to the area and topology of protruding surfaces and located in these regions It can effectively penetrate cancer lesions without any leakage. The main purpose of the invention is to create a leak-proof system that adapts to different topological surfaces. The invention concerns the provision of a Leipzig applicator. The Leipzig applicator, which is the subject of the invention, is primarily described in volume 10. Brachytherapy is used during the treatment of many cancers, including craniopharmacy. It can be used in its application. The applicator, which is the subject of the invention, has a structure... Thanks to this, it conforms perfectly to the uneven surfaces of areas such as the hands, neck, and spine. This ensures complete compatibility, unlike existing techniques, without any radiation. No leakage is occurring. No radiation leakage is occurring. 15 ensuring all of the applied radiation is delivered directly to the targeted area. This makes it possible. Moreover, thanks to this complete compatibility, the targeted region It is possible to interact with all cancer cells. Furthermore, the invention is the subject of this study. The Leipzig applicator can completely cover uneven surfaces during treatment. Thanks to this, the applied radiation does not leak and only affects the targeted area. 20 This ensures that healthy cells are not exposed to any radiation during treatment. Exposure to the Leipzig applicator, which is the subject of this invention, is also prevented. the structure in which the applicator is applied depends on the topological structure of the area where it is applied during treatment. This allows for a complete adaptation. Therefore, the applicator allows the body to reach the cancerous tissue. It has a structure that can be applied to each region. The current technique includes 25 Due to the shortcomings of other Leipzig applicators, problems occurred in areas such as the nose and spine. Some cancer lesions require the current applicators to adapt to these areas. Therefore, treatment with brachytherapy is either not possible or is interrupted. However The discovery concerns every lesion that can be treated with brachytherapy. It has a structure that can be used. Thus, patients can access different treatment methods. They are not referred elsewhere and their treatments are carried out with brachytherapy. Another objective of the invention is to provide a reliable Leipzig applicator. The subject of the invention is... The applicator's design prevents any radiation leakage from occurring. This prevents the structure in question from being fully compatible with the application area. This ensures that the radiation remains between the applicator and the application area, and It prevents leaks. Preventing such radiation leaks from occurring both exposure of both the patient and the practitioner (healthcare personnel) to radiation This prevents leaks. Preventing these leaks makes the treatment more effective. 5 This ensures both the safety of the patient and the safety of the healthcare worker. Explanation of the Figures Figure 1: Assembly view of the Leipzig Applicator. Figure 2: Cross-sectional view of the Leipzig Applicator 10 Figure 3: Cross-sectional view of the movable tip structure of the Leipzig Applicator. Figure 4: Isometric view of the movable tip in the structure of the Leipzig Applicator. Descriptions of the Elements / Components Constituting the Invention 1. Leipzig applicator 15 2. Source link section 3. Support 4. Applicator connection part 5. Applicator body 6. Applicator body opening 20 10. Movable ends 11. Movable end pad 12. Movable end cap 13. Global flight 14. Movable end spring 25 15. Movable end plate 16. Movable end plate 17. Movable end wedge 18. Movable end channel 6 Detailed Description of the Invention The invention is a multifunctional Leipzig applicator that can adapt to different topological surfaces. It is related to the applicator described in the invention, which is particularly used in the treatment of cancer types such as skin cancer. in tumor detection (determining parameters such as depth, width, etc.) It is used. Thanks to the structural features of the aforementioned applicator, indentations and 5 It easily adapts to the area and topology of surfaces with protrusions (unevenness) and effectively treats cancer lesions in these areas without any leakage. It is available for use. There are 10 different types of brachytherapy devices used particularly in cancer treatment. Leipzig applicator (1) which can adapt to topological surfaces; - to establish the connection between the radiation source and the applicator (1) a source link part (2), - the source link section (2) is followed by the source link located between part (2) and applicator connection part (4), containing 15 a cylindrical and hollow retaining support for radiation to pass through (3), - applicator connector that connects the holder support (3) and the applicator body (5) part (4), - Radiation coming from the retaining support (3) reaches the cancerous tissue 20 a round and hollow structure for transmission, all around its circumference Movable tips (10) positioned on the applicator body opening (6) applicator body (5), containing - at its very tip, it is about to come into contact with cancerous tissue, and this contact During this time, the spherical tip (13) with a 360 degree swivel structure, the spherical tip (13) 25 located on it and between the spherical end (13) and the movable end spring (14) The movable end plate (16) located on the spherical end (13) applies pressure. inside the movable end cap (12) and the movable end base (11) movable end spring (14) that enables it to enter, movable end cap (12) 30 which stops its progress inside the movable end base (11) plate (15), located on the edge of the movable end cap (12) and movable by inserting the end cap (12) into the movable end base (11) The movable end wedge (17) and movable end that enters the end channel (18) 7 at least one containing a movable end channel (18) located next to the base (11). number of movable ends (10) It includes. The Leipzig applicator (1), which is the subject of the invention, contains 36 movable tips (10). 5 The application method of the Leipzig applicator (1) which is the subject of the invention; i. connecting the retaining support (3) to the radiation source, ii. the spherical end (13) of the movable ends (10) will touch the cancerous tissue placement in this way, iii. with the opening of the radiation source, the radiation is applied with the Leipzig applicator (1) 10 application to cancerous tissue It includes the steps involved in the process. The Leipzig applicator (1), which is the subject of the invention, is used for tumor detection and in addition to brachytherapy. in its localization, in photodynamic therapy, in heat therapy (thermotherapy) and placement and 15 It can also be used as a fastening device. In one application of the invention, the inner diameter of the Leipzig applicator (1) is 1 cm, 2 cm or 3 cm. The inner diameter of the applicator (1) depends on the location and size of the area where the cancerous tissue has spread. are selected. The preferred sizes provide the best fit for uneven body surfaces. It has been determined in such a way as to provide the most compatible Leipzig tissue with cancerous tissue. The applicator (1) can be selected. The Leipzig applicator (1) has different inner diameter values. Thanks to its being the subject of the invention, the applicator (1) is both the other in the existing art. It can be integrated into applicators as well as a single, standalone product. It can be used. The applicator (1) subject to the invention has an inner diameter of 25, regardless of its length. It contains 36 movable tips (10). In other words, the Leipzig applicator (1) Movable end when the inner diameter length is 1 cm, 2 cm or 3 cm (10) The number is the same, 36 pieces. Although the inner diameter length changes, the movable tip (10) the number remains the same, the movable tip is directly proportional to the inner diameter length (10) It is also a change in dimensions. For example, 30 where the inner diameter length is short. In applications, the movable end (10) is small in size, while the inner diameter length is large. In such cases, the movable tip (10) is large in size. Thus, in every application There are a total of 36 movable tips (10). 8 The channels carrying the radiation source in the Leipzig applicator (1) which is the subject of the invention Made from medical-grade biocompatible stainless steel, machined with high precision. These materials are used for the effective transmission and accurate direction of radiation. It is of critical importance for the part of the applicator (1) that comes into direct contact with the patient. The global end (13) is made of medical grade biocompatible stainless steel and the outer parts are 5 It is coated with biocompatible plastic or silicone. These materials are suitable for application. to increase patient comfort and provide a tissue-compatible surface during the procedure is preferred. The movable end spring (14) is also made of medical grade biocompatible stainless steel. is manufactured here in very thin sections due to the brittle material properties. Medical-grade biocompatible stainless steel will be preferred over tungsten for the springs to be produced. It is made of medical-grade biocompatible stainless steel, offering flexibility, durability, and It is a suitable material for spring production due to its biomedical compatibility. Medical and These springs, used in biomedical applications, are both long-lasting and body-friendly. It can function safely within it. The Leipzig applicator (1), which is the subject of the invention, source connection part (2), holder support (3), applicator connection part (4), applicator 15 body (5), applicator body opening (6), movable tips (10), movable tip base (11), movable end cap (12), movable end bottom plate (15), movable end top plate (16), Movable end wedge (17) and movable end channel (18) medical grade biocompatible stainless steel It is made of steel. The Leipzig applicator (1), which is the subject of the invention, can be attached to existing applicators and has new functions. It has at least one movable end structure (10) that provides a win. This structure is a retaining support (3) and the applicator body (5) and the applicator connection part (4) connect to each other. by attaching to the skin's surface, radioactive rays from the radiation source are transmitted to the skin's surface. It enables application. To the applicator body (5), the applicator body opening (6) 25 at least one fully enclosed movable end (10), movable end holder (11), movable end header (12), spherical end (13), movable end spring (14), movable end lower plate (15), movable end top plate (16), movable end wedge (17) and movable end channel (18) It includes. The movable ends (10) formed by the combination of these elements, movable 30 through the tip base (11) to the applicator body (5), to the applicator body mouth (6) part. They are mounted side by side. The movable end pad (11), movable end pad It serves as a housing for the plate (15) and the movable end spring (14), while the movable end a movable end channel (18) that supports the vertical movement of the head (12) It contains a movable end wedge located on the movable end cap (12). 9 (17) prevents radiation leakage for different heights. This movable end wedge (17) moves along the movable end channel (18) on the movable end base (11). By doing so, it enables access to the desired height. The movable end spring (14) has different protrusions. for body surfaces with amounts of spherical tip (13) to reach the required height The spherical tip (13) is connected to the skin surface by the movable tip spring (14). it makes contact and, thanks to the force applied by the spring, a certain amount of pressure is applied to the skin tissue. It provides a leak-proof seal by applying pressure, thus making it suitable for radiation applications. It offers high accuracy and safety. All of the movable tips (10) are 1 piece. It is attached to the applicator body (5). In the final product, each spherical tip (13) is a It is integrated into the movable ends (10). In other words, in each application of the invention, 10 Each of the movable ends (10) includes one spherical end (13). Therefore, each of the invention In the application, the number of movable ends (10) and the number of spherical ends (13) are the same. The invention is a in its application 36 movable tips (10) and the same number 36 spherical tips (13) However, this number may change depending on the inner diameter of the applicator. The Leipzig applicator (1), which is the subject of the invention, determines the location of the tumor during brachytherapy. an indirect role as a tool to help determine its size and boundaries It plays a role. This supportive function is especially important in targeting the tumor with radiation. directing it to the tissue and protecting healthy tissues is of great importance It carries. The aforementioned Leipzig applicator (among the other 20 in the current technology) to ensure effective use (as in the use of Leipzig applicators) First, the exact location and size of the tumor must be determined. This In this regard, computed tomography (CT), magnetic resonance imaging (MRI) or Advanced imaging techniques such as ultrasound are used. Leipzig applicators. It is generally preferred in the treatment of superficial or near-superficial tumors. 25 Radiation planning is carried out based on imaging results. and tumor areas are clearly defined. The aforementioned Leipzig applicator (1), During treatment, it is placed in the area where the tumor is located. In this process, the specialist The team determines the boundaries of the tumor by palpation (manual examination) or imaging data. It ensures accurate positioning by matching. The applicator (1) has a precise 30° placement allows radiation to be effectively focused on the tumor. This facilitates the treatment process. During the treatment process, the Leipzig applicator (1) must be in the correct position. to check if it is not present, fluoroscopy (real-time X-ray imaging) or Radiation planning systems are used. These methods aim radiation at the tumor. ensuring that it is distributed within the defined limits and the effectiveness of the treatment The Leipzig applicator (1) increases the distance between the radiation source and the tumor. By stabilizing it, it helps to determine the location of the tumor more clearly. Simulations and dose distribution calculations performed before treatment assess both the tumor's size. both in determining the boundaries and in directing radiation to the correct target 5 It plays a critical role. As a result, the applicator (1) that is the subject of the invention is included in the current art. Like Leipzig applicators, its role in tumor detection has shifted from being a direct diagnostic tool. Furthermore, it helps to clarify tumor boundaries during treatment planning. It is used as an auxiliary tool that provides this. This process is carried out by an experienced oncologist. Integration of advanced imaging technologies with the team's multidisciplinary approach 10 Thanks to this, it is becoming more precise and effective. However, it differs from the current technique. As such, the applicator (1) which is the subject of the invention does not allow any radiation leakage and this This allows for much more effective treatment and diagnosis. The Leipzig applicator (1), which is the subject of the invention, is mainly used in brachytherapy and especially in 15 Although it was designed for use in the treatment of superficial tumors, it is suitable for various clinical settings. depending on the requirements, device design specifications and approved protocols It can also be adapted to other areas of use. The applicator (1) that is the subject of the invention, tumor It can be used for detection and localization of radiation. The aforementioned applicator (1) Besides treatment, determining the location of superficial tumors or lesions is also important. 20 This can be helpful. For example, radiological simulations or radiation planning. It can be used to clarify the boundaries of the area to be biopsied during the procedure. This feature contributes to the precise localization of superficial tumors. The Leipzig applicator (1), which is the subject of the invention, provides during photodynamic therapy (PDT). It can also be used. Photodynamic therapy uses a light-sensitive substance to treat cancer. 25 It is a method aimed at destroying the cells. The aforementioned applicator (1), superficial or to precisely deliver the light source to lesions near the surface It is possible to modify it. This feature is particularly important in superficial cancers such as skin cancers. It is beneficial in the treatment of malignancies. The Leipzig applicator (1) is the subject of the invention. It can also be used during heat therapy (thermotherapy). Heat therapy, cancer 30 a device used to destroy cells or increase the effectiveness of radiotherapy This is the method. The applicator (1) in question applies heat to the target tissue. They can be modified to provide this. For example, microwave or ultrasound. It can be used as a guiding device to direct the waves. The subject of the invention 11 The Leipzig applicator (1) also serves as a placement and fixing device. It can be used. The aforementioned applicator (1) is used for non-invasive diagnosis or treatment. It can be used as a stabilizing or positioning tool in these methods. For example, fixing an ultrasound probe or other medical device to a specific area and It can provide support for proper guidance. The 5 items that are the subject of the invention. The applicator (1) possible areas of use other than brachytherapy depend on the modification of the device and It is adaptable to suit clinical needs and is applicable in these areas. It offers a structure that is open to various technical improvements in order to enhance it. 15 25 12 REFERENCES [1] Pérez-Calatayud J, Granero D, Ballester F, Puchades V, Casal E, Soriano A, Crispín V. A dosımetrıc study of leıpzıg applıcators. Int. J. Radiation Oncology Biol. Phys., Vol. 62, No. 2, pp. 579–584, 2005 10 20 30

Claims

13 REQUESTS 1. Particularly used during brachytherapy, which is applied in cancer treatment, and The Leipzig applicator (1) can adapt to different topological surfaces. Feature; 5 - to establish the connection between the radiation source and the applicator (1) a source link section (2), - the source link section (2) is followed by the source link located between part (2) and applicator connection part (4), through which The retaining support, which is cylindrical and hollow, allows radiation to pass through. 10 (3), - applicator connector that connects the holder support (3) and the applicator body (5) part (4), - Radiation coming from the retaining support (3) to the cancerous tissue It is round and hollow in shape, with 15 mm around its entire circumference, for the purpose of transmitting the signal. Movable tips (10) positioned on the applicator body opening (6) applicator body (5), containing - at its very tip, it is about to come into contact with cancerous tissue, and this contact During this time, the spherical tip (13) has a 360 degree movable structure, the spherical tip (13) located on it and between the spherical end (13) and the movable end spring (14) 20 The movable end plate (16) located on the spherical end (13) applies pressure. inside the movable end cap (12) and the movable end base (11) movable end spring (14) that enables it to enter, movable end cap (12) movable end pad (11) stops its progress inside the movable end pad plate (15), located on the edge of the movable end cap (12) and movable 25 by inserting the end cap (12) into the movable end base (11) The movable end wedge (17) and movable end that enters the end channel (18) at least one containing a movable end channel (18) located next to the base (11). number of movable ends (10) It includes. 30 2. According to claim 1, a Leipzig applicator (1) has 36 movable tips. (10) is included. 14 3. According to claim 1, a Leipzig applicator (1) is characterized by its ability to perform brachytherapy in addition to other treatments. In tumor detection and localization, in photodynamic therapy, in heat therapy. (thermotherapy) and its use as a stabilization and fixation device.

4. According to claim 1, a Leipzig applicator (1) is characterized by the applicator body (5) its inner diameter is 1, 2 or 3 cm. 5 5. A Leipzig applicator (1) according to any of claims 1-4, and its characteristic is: The spherical tip (13) is made of medical grade biocompatible stainless steel, Their outer parts are coated with biocompatible plastic or biocompatible silicone.

6. A Leipzig applicator (1) according to any of claims 1-4, and its characteristic is: source connection part (2), holder support (3), applicator connection part (4), 10 applicator body (5), applicator body nozzle (6), movable tips (10), movable end pad (11), movable end cap (12), movable end bottom plate (15), movable end top plate (16), movable end wedge (17) and movable end channel (18) It is manufactured from medical-grade biocompatible stainless steel.

7. The method of use of a Leipzig applicator (1) according to claim 1 is characterized by; 15 i. connecting the retaining support (3) to the radiation source, ii. the spherical end (13) of the mobile ends (10) onto the cancerous tissue placed in such a way that it touches, iii. by switching on the radiation source, radiation is applied via the Leipzig applicator (1) application to cancerous tissue 20 It includes the steps of the process. 30 35

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