Self-adaptive sliding rotary type modularized after-loading source applicator

Abstract

The invention relates to a self-adaptive sliding rotation type modularized after-loading source applicator which comprises a uterine cavity catheter and at least two fornix catheters, a central positioning base is arranged at the end, away from the uterus, of the uterine cavity catheter, and at least two sliding rotation mechanisms are arranged on the surface of the central positioning base. Each set of sliding and rotating mechanism comprises a T-shaped sliding groove and a rotating column, the T-shaped sliding groove is formed in the length direction of the central positioning base, the rotating column is fixedly connected with one fornix guide pipe, a T-shaped column matched with the T-shaped sliding groove in size is arranged at one end of the rotating column, and the rotating column is screwed on the groove bottom face of the T-shaped sliding groove through a locking bolt. Through functional combination of multiple modules such as sliding adjustment, angle rotation and limiting control, adaptive adjustment of a non-standard uterus anatomical structure is realized, high modularization, individualization and image guide compatibility are realized, and conformity, safety and repeated operation consistency of close-range radiotherapy of gynecological tumors in complex patients are remarkably improved.

Description

Technical Field

[0001] This invention belongs to the field of applicator technology, and in particular relates to an adaptive sliding rotary modular post-applicator. Background Technology

[0002] Cervical cancer and endometrial cancer are two common and serious malignant tumors of the reproductive system among women worldwide. According to the World Health Organization, cervical cancer ranks fourth in incidence among female cancers globally, with over 600,000 new cases annually, particularly high in developing countries. The incidence of endometrial cancer is continuously rising in high-income countries, including my country, and has become the most common gynecological malignancy in some high-income countries. Its incidence is increasing year by year due to population aging and the prevalence of obesity. Radiation therapy is one of the important treatment methods for both types of cancer, especially playing a central role in the standard treatment of cervical cancer, and is also widely used in patients with inoperable or recurrent endometrial cancer.

[0003] Brachytherapy, also known as intracavitary therapy, plays an irreplaceable role in the treatment of gynecological tumors due to its high-dose, concentrated effect on the tumor target area while reducing radiation to adjacent normal tissues. Currently, the commonly used three-tube afterloading applicator in clinical practice includes one uterine catheter and two vaginal fornix catheters. Its structure is mostly rigidly connected and symmetrically designed, primarily suitable for cases where the uterus is anatomically centered.

[0004] However, in actual clinical practice, a significant number of patients have physiological uterine displacement, postoperative malformations, adhesions, or other anatomical variations. Traditional catheter devices cannot be adjusted independently, and the fornix and uterine cavity catheters often have a forced symmetrical relationship, posing challenges in positioning, fixation, and target dose distribution. For example, it is difficult to achieve a targeted dose distribution in actual treatment, resulting in the deeper fornix not receiving the ideal dose. This necessitates invasive techniques involving intracavitary three-tube insertion combined with interstitial implantation in some cases with complex anatomical structures, further increasing patient pain and infection risks. Existing three-tube afterloading applicator technology only has partial degrees of freedom and cannot freely adjust the relative position of the uterine cavity catheter and the fornix catheter, affecting the protection of adjacent organs such as the rectum and bladder, and limiting the consistency control in individualized treatment and repeated treatment processes. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide an adaptive sliding rotary modular afterloading applicator that adaptively adjusts the catheter position according to the position of the patient's uterine fornix, thereby improving the individualized treatment effect and consistency in repeated treatments.

[0006] The technical solution adopted by the present invention to solve its technical problem is as follows: an adaptive sliding rotary modular afterloading applicator is provided, including a uterine catheter and at least two dome catheters. The end of the uterine catheter away from the uterus is provided with a central positioning base. The surface of the central positioning base is provided with at least two sets of sliding rotation mechanisms. Each set of sliding rotation mechanisms includes a T-shaped groove arranged along the length direction of the central positioning base and a rotating column fixedly connected to one of the dome catheters. One end of the rotating column is provided with a T-shaped column that matches the size of the T-shaped groove. The neck and end of the T-shaped column are both cylindrical. The center of the rotating column is also provided with a threaded through hole coaxial with the T-shaped column. The rotating column is tightened to the bottom surface of the T-shaped groove by a locking bolt that matches the threaded through hole.

[0007] Preferably, one side of the T-shaped groove is provided with a long axis scale arranged along the length direction.

[0008] Preferably, the end of the central positioning base furthest from the uterus is provided with a horizontal axis scale.

[0009] Preferably, a limiting slider is slidably fitted outside the uterine catheter, and the limiting slider has a threaded through hole on its surface. The limiting slider is tightened to the outer periphery of the uterine catheter by a locking bolt that matches the threaded through hole.

[0010] Preferably, the end of the dome duct facing the uterus is provided with a cap-shaped pad.

[0011] The present invention also provides a method of using the above-described adaptive sliding rotary modular post-loading applicator, comprising the following steps:

[0012] (1) Based on the preoperative images of the brachytherapy, determine the appropriate position of the limiting slider and tighten it.

[0013] (2) Insert the uterine catheter into the patient’s uterine cavity, try to touch the uterine cavity wall, and confirm and record the appropriate position of the limiting slider a second time.

[0014] (3) Insert the two dome catheters into the patient's dome area while ensuring that the locking bolts are not tightened;

[0015] (4) After the end of the fornix catheter adapts to the patient's anatomical deviation, tighten the locking bolt to fix the relative position between the fornix catheter and the uterine catheter;

[0016] (5) Read the scale position on the central positioning base and the uterine catheter to complete the marking and recording of the source path;

[0017] (6) Take positioning images, formulate a treatment plan based on the images and delineate the target area, and finally load the afterloading radiation source into the catheter for radiotherapy.

[0018] (7) In subsequent treatment, the catheter is repositioned according to the recorded scale to maintain the consistency of dose distribution.

[0019] The beneficial effects are as follows: This invention achieves adaptive adjustment to non-standard uterine anatomical structures through a combination of multiple modular functions such as sliding adjustment, angle rotation, limit control, and scale visualization. It possesses high modularity, individualization, and image-guided compatibility, significantly improving the conformity, safety, and repeatability of brachytherapy for gynecological tumors in complex patients. Compared to existing products, this invention offers significant improvements in structural flexibility, adjustment precision, and image visualization. Furthermore, its adjustable sliding and rotation functions provide an asymmetric source distribution path, enhancing target conformity and dose distribution uniformity, demonstrating promising prospects for industrial transformation and clinical application value. Attached Figure Description

[0020] Figure 1 This is a main view of an adaptive sliding rotary modular post-installation applicator.

[0021] Figure 2 An exploded view of an adaptive sliding rotary modular post-installation source generator.

[0022] Figure 3 for Figure 1 Enlarged view of the sliding rotation mechanism.

[0023] Figure 4 for Figure 1 Enlarged view of the central positioning base.

[0024] Among them, 1-uterine cavity catheter; 101-limiting slider; 102-locking bolt; 103-limiting scale; 2-fornix catheter; 201-cap-shaped top pad; 3-central positioning base; 301-long axis scale; 302-horizontal axis scale; 4-sliding rotation mechanism; 401-T-shaped groove; 402-rotating column; 403-T-shaped column.

[0025] The same markings in each diagram represent the same component. Detailed Implementation

[0026] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the teachings of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0027] like Figure 1 , 2As shown, this invention provides an adaptive sliding rotary modular afterloading applicator, mainly applicable to non-standard uterine anatomical structures, including a uterine cavity catheter 1 and two dome catheters 2. The end of the uterine cavity catheter 1 away from the uterus is provided with a central positioning base 3. The surface of the central positioning base 3 is provided with two sets of sliding rotation mechanisms 4. Each set of sliding rotation mechanisms 4 includes a T-shaped groove 401 arranged along the length direction of the central positioning base 3 and a rotating column 402 fixedly connected to one of the dome catheters 2. One end of the rotating column 402 is provided with a T-shaped column 403 that matches the size of the T-shaped groove 401. The neck and end of the T-shaped column 403 are both cylindrical. The center of the rotating column 402 is also provided with a threaded through hole coaxial with the T-shaped column 403. The rotating column 402 is tightened to the bottom surface of the groove of the T-shaped groove 401 by a locking bolt 102 that matches the threaded through hole.

[0028] In a kind of Figure 1 In the specific embodiment shown, one side of the T-shaped groove 401 is provided with a long axis scale 301 arranged along the length direction. Additionally, in another embodiment... Figure 4 In the specific embodiment shown, the central positioning base 3 has a horizontal axis scale 302 at the end furthest from the uterus. By directly observing the long axis scale 301 and the horizontal axis scale 302 on the surface of the central positioning base 3 outside the body, the consistent recording and reproduction of the depth of the uterine fundus probed by the uterine catheter 1 in a single patient can be achieved.

[0029] In a kind of Figure 1 , 2 In the specific embodiment shown, a limiting slider 101 is slidably fitted around the uterine catheter 1. The limiting slider 101 has a threaded through hole on its surface. The limiting slider 101 is tightened onto the outer periphery of the uterine catheter 1 by a locking bolt 102 that matches the threaded through hole, serving as a limiter to control the insertion depth into the uterus and prevent dose deviation caused by excessive insertion. A limiting scale 103 is provided on the surface of the end of the uterine catheter 1 closest to the uterus to record the position of the limiting slider 101, achieving consistent recording and reproduction of the limiting slider for a single patient. The limiting scale 103 starts from the tip of the uterine catheter, with increments of 0.5 cm, totaling 8 cm. The limiting scale 103 is an imaging scale, made of a radiopaque material to ensure correct locking position during positioning image capture.

[0030] In a kind of Figure 1 , 2 In the specific embodiment shown, the end of the vaginal fornix catheter 2 facing the uterus is provided with a cap-shaped top pad 201, which naturally stops in place on the inner wall of the vaginal fornix after insertion, thus achieving stable positioning of the catheter.

[0031] In other embodiments, the end of the uterine catheter 1 and the fornix catheter 2 facing the uterus is provided with a flexible pre-bent section with a bending angle range of 0 to 30°, which is used to conform to the anatomical shape of the uterus in different flexed positions. At the same time, it cooperates with the sliding rotation mechanism 4 to realize multi-angle and multi-position adjustment of the catheter tip, so that the catheter exit direction can be flexibly adjusted according to the patient's anatomical characteristics, optimize the radiation source distribution path, improve the target area dose concentration, and reduce non-specific irradiation of adjacent important organs such as rectum and bladder.

[0032] In one specific embodiment, the maximum stroke of the T-shaped groove 401 is 4 cm. An angle limiting block is provided on the outer periphery of the T-shaped column 403, and the dome conduit 2 has a rotation angle range of ±30° with its angle parallel to the uterine cavity conduit 1 defined as 0°. This stroke can accommodate most non-standard uterine anatomical structures.

[0033] The components of this invention are made of one or more of polyetheretherketone (PEEK), titanium alloy, or other medical-grade metal materials, and can withstand high-pressure steam sterilization for repeated use. The internal channels of the uterine catheter 1 and the fornix catheter 2 are polished and have a low-friction coating to facilitate the smooth passage of the loaded radiation source. The long axis scale 301, horizontal axis scale 302, and limiting scale 103 are made of materials that are visible in MRI or CT images, enabling this invention to support image-guided brachytherapy (IGBT). The catheter placement path is recorded during the first treatment and can be further used for reference positioning and repeated placement in subsequent treatments.

[0034] The operation steps of this invention are as follows:

[0035] (1) Based on the pre-treatment images, determine the appropriate position of the limiting slider 101 and tighten it.

[0036] (2) Insert the uterine catheter 1 into the patient's uterine cavity, try to touch the uterine cavity wall, and confirm and record the appropriate position of the limiting slider 101 a second time.

[0037] (3) Insert the two dome catheters 2 into the patient's dome while ensuring that the locking bolt 102 is not tightened;

[0038] (4) After the end of the dome catheter 2 adapts to the patient's anatomical deviation, tighten the locking bolt 102 to fix the relative position between the dome catheter 2 and the uterine catheter 1;

[0039] (5) Read the scale positions on the central positioning base 3 and the uterine catheter 1, and complete the source path marking and recording;

[0040] (6) Take positioning images, formulate a treatment plan based on the images and delineate the target area, and finally load the afterloading radiation source into the catheter for radiotherapy.

[0041] (7) In subsequent treatment, the catheter is repositioned according to the recorded scale to maintain the consistency of dose distribution.

[0042] It should be noted that the current implementation does not include interstitial implantation catheters or puncture structures, but the present invention does not exclude the future expansion of implantation catheter structures according to clinical needs, and this is not limited to an essential technical feature in the current claims.

Claims

1. An adaptive sliding rotary modular afterloading applicator, comprising a uterine catheter and at least two dome catheters, characterized in that, The end of the uterine catheter furthest from the uterus is provided with a central positioning base, and the surface of the central positioning base is provided with at least two sets of sliding and rotating mechanisms. Each set of the sliding rotation mechanism includes a T-shaped slide groove arranged along the length of the central positioning base and a rotating column fixedly connected to one of the dome guide tubes. One end of the rotating column is provided with a T-shaped column that matches the size of the T-shaped groove. The neck and end of the T-shaped column are both cylindrical. The center of the rotating column is also provided with a threaded through hole coaxial with the T-shaped column. The rotating column is tightened to the bottom surface of the T-shaped groove by a locking bolt that matches the threaded through hole.

2. The adaptive sliding rotary modular post-installation source device according to claim 1, characterized in that, The T-shaped groove has a long axis scale arranged along its length on one side.

3. The adaptive sliding rotary modular post-loading applicator according to claim 1, characterized in that, The central positioning base has a horizontal axis scale at the end furthest from the uterus.

4. The adaptive sliding rotary modular post-loading applicator according to claim 1, characterized in that, The uterine catheter is slidably fitted with a limiting slider, the surface of which has a threaded through hole. The limiting slider is tightened onto the circumference of the uterine catheter by a locking bolt that matches the threaded through hole.

5. The adaptive sliding rotary modular post-loading applicator according to claim 1, characterized in that, The dome duct has a cap-shaped pad at the end facing the uterus.

6. A method for using an adaptive sliding rotary modular post-loading applicator, characterized in that, The adaptive sliding rotary modular post-loading applicator as described in any one of claims 1 to 5 includes the following steps: (1) Based on the preoperative images of the brachytherapy, determine the appropriate position of the limiting slider and tighten it. (2) Insert the uterine catheter into the patient’s uterine cavity, try to touch the uterine cavity wall, and confirm and record the appropriate position of the limiting slider a second time. (3) Insert the two dome catheters into the patient's dome area while ensuring that the locking bolts are not tightened; (4) After the end of the fornix catheter adapts to the patient's anatomical deviation, tighten the locking bolt to fix the relative position between the fornix catheter and the uterine catheter; (5) Read the scale position on the central positioning base and the uterine catheter to complete the marking and recording of the source path; (6) Take positioning images, formulate a treatment plan based on the images and delineate the target area, and finally load the afterloading radiation source into the catheter for radiotherapy. (7) In subsequent treatment, the catheter is repositioned according to the recorded scale to maintain the consistency of dose distribution.

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