Gynecological tumor multichannel after-loading radiotherapy source applicator capable of automatically post-expanding

Abstract

The invention relates to a gynecological tumor multichannel after-loading radiotherapy source applicator capable of automatically post-expanding, which comprises a central radioactive source catheter, radioactive source catheter sub-blades, a linkage device, a post-expanding gear knob and a fixed handle, and is characterized in that the fixed handle is arranged at the bottom of the central radioactive source catheter; a rear dilation gear knob is arranged at the upper part of the fixed handle; the rear expansion gear knob is connected with a linkage device; the linkage device is provided with a radioactive source conduit branch blade; planting needle holes are formed in the radioactive source catheter branch blades; the source applicator has the advantages that when expansion is not started, the source applicator is small in size and can be conveniently placed into the vagina; after the afterloading radiotherapy source applicator is placed in the vagina, the expansion degree of the afterloading radiotherapy source applicator in the vagina can be regulated and controlled through an external control key, especially the expansion degree of the top end can be larger than that of the middle rear section, and the top end of the source applicator channel can reach the top end of the vagina and extend towards the outer side of the periphery. The conformity and individualization of the radioactive source channel can be realized by flexibly adjusting the position of the radioactive source catheter leaf division, and the radiotherapy effect of the vagina tip and the cervix uteri is obviously improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more specifically, to a multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-dilated.

Background Art

[0002] Radiotherapy plays a very important role in the treatment of gynecological tumors such as cervical cancer, vaginal cancer, and endometrial cancer. Taking cervical cancer as an example, radiotherapy as the preferred treatment method has the following natural advantages: (1) High radiation sensitivity of squamous cell carcinoma; (2) Good tolerance of adjacent normal organs; (3) The natural body cavities of women (vagina and uterine cavity) are convenient for intracavitary afterloading radiotherapy. Cervical cancer radiotherapy includes the combination of external and internal irradiation, and afterloading radiotherapy is an indispensable and important means, which is the key link for the radical cure of cervical cancer radiotherapy. Intracavitary radiotherapy, also known as afterloading radiotherapy, refers to a method of using a cavity to place a source catheter to deliver a high-dose-rate radioactive element to the tumor center for killing. The combined treatment method of external and internal irradiation for cervical cancer ensures both "extensive irradiation" (pelvic external irradiation) and "accurate irradiation" (afterloading radiotherapy), laying a solid foundation for the radical cure of cervical cancer radiotherapy. At present, most intracavitary afterloading applicators for cervical cancer are of fixed types, and the commonly used applicators at home and abroad are ovoid applicators and single-channel columnar applicators.

[0003] However, the above-mentioned ovoid applicators and single-channel columnar applicators are mostly of fixed types, and they have defects such as poor individualization and conformity during treatment, resulting in underdosage in some target areas and uneven dose distribution. The recurrence rate of tumors caused by underdosage in the target area is very high.

[0004] With technological innovation, 3D-printed individualized vaginal multi-channel applicators have been developed and applied. 3D printing is a new technology that uses reverse reconstruction technology to print all puncture needle tracks. It is more individualized and accurate. The afterloading technology guided by 3D printing templates has been initially applied to interstitial afterloading radiotherapy for cervical cancer and has obtained good application value. However, there is still room for improvement in 3D template printing technology. First, the shape and position of tumors often change uncertainly after multiple radiotherapy sessions, resulting in deviations in the puncture needle tracks and the need to remake templates multiple times. Second, the unit price of 3D printing templates is relatively high, bringing a great economic burden to patients, and the acceptance of patients is poor. At present, it has not been widely promoted and is only carried out in a few units. Given the high price of 3D templates, many patients cannot afford them. For patients with poor conformity that cannot be achieved by traditional applicators, doctors currently mostly use freehand insertion, which requires high doctor skills, but also has disadvantages such as repeated needle insertion and adjustment, resulting in bleeding, infection, long time consumption, and poor patient experience.

[0005] Chinese Patent Application: CN112933424A discloses a source applicator, which includes a source tube and a movable part. The movable part includes a movable airbag and a radiation head. The two ends of the movable airbag are respectively connected to the source tube and the radiation head, and the movable airbag has a through cavity, and the cavity communicates with the source tube and the radiation head; the radiation head can move relative to the source tube. The source applicator provided in this application can accurately locate the source position, can increase the irradiation dose of the lesion area and reduce the irradiation dose of normal tissues.

[0006] Chinese Patent Application: CN117653931A discloses a uterine source applicator, which includes a sleeve, a source applicator body and a radiation source catheter; the source applicator body is coaxially sleeved in the sleeve and is used for inserting into the uterus. The rear section of the source applicator body can extend out of the sleeve and expand into an arc-shaped eight-shaped outward expansion structure or retract into the sleeve. The rear end of the source applicator body is used to support the inner wall of the uterus; the source applicator body includes two guiding and supporting tubes arranged at intervals, and each guiding and supporting tube is inserted with a radiation source catheter. The guiding and supporting tube includes a straight tube section and a bent tube section. When the source applicator body extends out of the sleeve, the bent tube sections of the two guiding and supporting tubes expand in an arc shape in opposite directions to form an eight-shaped outward expansion structure; the radiation source catheter extends into the source applicator body and can inject a radiation source into the uterus, and it is made of an aluminum alloy material. This uterine source applicator is more in line with the uterine structure of Asian women, and has better CT or MRI scanning imaging effects, and can improve the overall radiotherapy treatment effect.

[0007] In summary, there is an urgent need for a multi-channel afterloading source applicator for gynecological tumors that can automatically expand backward, which can not only adjust the top expansion angle according to the vaginal shape and cervical tumor position of different patients, has a higher conformity, can be individualized, but also can be repeatedly disinfected and reused, reduces the radiotherapy cost, and makes the patient acceptance higher.

Summary of the Invention

[0008] The purpose of the present invention is to provide a multi-channel afterloading radiotherapy source applicator for gynecological tumors that can automatically expand backward, which can not only adjust the top expansion angle according to the vaginal shape and cervical tumor position of different patients, has a higher conformity, can be individualized, but also can be repeatedly disinfected and reused, reduces the radiotherapy cost, and makes the patient acceptance higher.

[0009] To achieve the above purpose, the technical solution adopted by the present invention is:

[0010] A multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-expanded, including a central radiation source catheter, radiation source catheter lobes, a linkage device, a post-expansion gear knob, and a fixed handle. It is characterized in that a central radiation source catheter is provided, the bottom of the central radiation source catheter is provided with a fixed handle, and the inside of the central radiation source catheter is hollow; a post-expansion gear knob is provided on the upper part of the fixed handle; the upper part of the post-expansion gear knob is connected to the linkage device; the linkage device and the post-expansion gear knob are both placed on the outer periphery of the central radiation source catheter; the post-expansion gear knob can control the linkage device to slide up and down on the outer periphery of the central radiation source catheter; the linkage device is provided with radiation source catheter lobes; the radiation source catheter lobes are provided with implant needle holes; there are several radiation source catheter lobes, and the several radiation source catheter lobes can be dispersed or combined as the linkage device slides up and down, and different angles of radiation source residence can be achieved by continuously adjusting different angles of the radiation source catheter lobes, and the combined form of the radiation source catheter lobes is a cylinder.

[0011] As a preferred example, the fixed handle is a cylindrical structure made of a flexible material.

[0012] As another preferred example, the post-expansion gear knob is threadedly connected to the central radiation source catheter, and the up and down movement of the post-expansion gear knob is adjusted by left and right thread rotation.

[0013] As another preferred example, the linkage device is provided with a slider, a connecting rod, and a support rod. The slider is sleeved on the periphery of the central radiation source catheter. A support rod is hinged above the slider, and the support rod is hinged to the middle and lower part of the radiation source catheter lobe; the connecting rod is connected to the bottom of the slider and the upper part of the post-expansion gear knob below, and the rod body is placed in a groove on the central radiation source catheter and can slide as the expansion gear knob moves up.

[0014] As another preferred example, a card slot is provided at the lower part of the linkage device. The card slot is provided on the central radiation source catheter and is clamped to the bottom of the radiation source catheter lobe, and the number of the card slots matches the number of the radiation source catheter lobes.

[0015] As another preferred example, the size of the implant needle hole is adapted to the size of the implant needle.

[0016] As another preferred example, anti-slip protrusions are provided on the outer periphery of the post-expansion gear knob.

[0017] The advantages of the present invention are as follows:

[0018] 1. Small and compact in volume, easy to insert: When the expansion is not started, the applicator is small and compact in volume, and can be easily inserted into the vagina, reducing the discomfort and pain of the patient. This design not only simplifies the operation process but also improves the comfort during the treatment.

[0019] 2. Precise control of the expansion shape: The degree of expansion of the applicator can be flexibly adjusted through an external control button, especially achieving a greater expansion amplitude at the top than in the middle and rear sections. The top can accurately reach the vaginal vault and extend laterally to the periphery, fully conforming to the individual anatomical structure and providing a more suitable radiation source channel shape for radiotherapy.

[0020] 3. Personalized adaptation to radiotherapy needs: The position of the catheter lobes can be flexibly adjusted according to the specific radiotherapy plan of the patient, optimizing the distribution shape of the applicator channel and maximizing the satisfaction of treatment needs. This feature significantly enhances the accuracy of target area coverage in the vaginal apex and cervical regions, thereby improving the radiotherapy effect.

Description of the Drawings

[0021] Attached Figure 1 is a schematic diagram of the opening and closing structure of a multi-channel afterloading radiotherapy applicator for gynecological tumors with automatic posterior expansion according to the present invention.

[0022] Attached Figure 2 is a schematic diagram of the internal structure after expansion of a multi-channel afterloading radiotherapy applicator for gynecological tumors with automatic posterior expansion according to the present invention (partial radiation source catheter lobes are omitted).

[0023] Attached Figure 3 is a schematic diagram of the combined internal structure of a multi-channel afterloading radiotherapy applicator for gynecological tumors with automatic posterior expansion according to the present invention (partial radiation source catheter lobes are omitted).

[0024] Attached Figure 4 is a cross-sectional view after expansion of a multi-channel afterloading radiotherapy applicator for gynecological tumors with automatic posterior expansion according to the present invention.

[0025] Attached Figure 5 is a partial enlarged view of the linkage device of a multi-channel afterloading radiotherapy applicator for gynecological tumors with automatic posterior expansion according to the present invention.

[0026] Attached Figure 6 is a partial enlarged view of the separation of the groove and the connecting rod of a multi-channel afterloading radiotherapy applicator for gynecological tumors with automatic posterior expansion according to the present invention.

Detailed Embodiments

[0027] The present invention will be further described below in conjunction with embodiments and with reference to the drawings.

[0028] The reference numerals and components involved in the drawings are as follows:

[0029] 1. Central radiation source catheter 11. Groove 12. Card slot 2. Radiation source catheter lobe 21. Card rod 22. Implantation needle hole 3. Linkage device 31. Slide block 32. Connecting rod 33. Support rod 4. Rear expansion gear knob 5. Fixed handle

[0030] Embodiment 1

[0031] In the description of the present invention, it should be understood that the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0032] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected to", "fixed", etc. should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection, an electrical connection, or communicable with each other; it may be directly connected, or indirectly connected through an intermediate medium, and may be the communication inside two components or the interaction relationship between two components, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0033] Please refer to Figures 1 - 6 , Figure 1 is a schematic diagram of the opening and closing structure of a multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-expanded according to the present invention; Figure 2 is a schematic diagram of the internal structure after expansion of a multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-expanded according to the present invention (partial radioactive source catheter lobes are omitted); Figure 3 is a schematic diagram of the internal structure after combination of a multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-expanded according to the present invention (partial radioactive source catheter lobes are omitted); Figure 4 is a sectional view after expansion of a multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-expanded according to the present invention; Figure 5 is a partial enlarged view of the linkage device of a multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-expanded according to the present invention; Figure 6 is a partial enlarged view of the separation of the groove and the connecting rod of a multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-expanded according to the present invention.

[0034] A multi-channel afterloading radiotherapy applicator for gynecological tumors that can be automatically post-expanded includes a central radioactive source catheter 1, radioactive source catheter lobes 2, a linkage device 3, a post-expansion gear knob 4, and a fixed handle 5; a central radioactive source catheter 1 is provided, a fixed handle 5 is provided at the bottom of the central radioactive source catheter 1, and the inside of the central radioactive source catheter 1 is hollow and can be used to place an intracavitary applicator tube or an implanting needle; grooves 11 are appropriately provided on the whole body of the tube; in this embodiment, preferably, the fixed handle 5 is a cylindrical structure made of a flexible material, which is convenient for the operator to hold.

[0035] In this embodiment, the fixed handle 5 can be fixed to the after-loading operating bed, and its upper part is provided with a rear expansion gear knob 4; the upper part of the rear expansion gear knob 4 is connected to a linkage device 3; both the linkage device 3 and the rear expansion gear knob 4 are arranged outside the central radiation source catheter 1; the rear expansion gear knob 4 can control the linkage device 3 to slide up and down outside the central radiation source catheter 1; the linkage device 3 is provided with radiation source catheter lobes 2; the radiation source catheter lobes 2 are provided with implant needle holes 21; there are several radiation source catheter lobes 2, and the several radiation source catheter lobes 2 can be dispersed or combined as the linkage device 3 slides up and down, and the combined shape of the radiation source catheter lobes 2 is a cylinder; the achieved technical effect is that when the expansion gear knob 4 is controlled, the linkage device 3 can respond, so as to continuously adjust the opening and closing angle of the radiation source catheter lobes 2. When this applicator is not started, the several radiation source catheter lobes 2 are in an unopened state; as Figure 1 shown, in this embodiment, it is preferred that the upper end of the radiation source catheter lobes 2 is cylindrical and the lower end is flared after being closely combined, so as to facilitate the control of the opening and closing angle of the radiation source catheter lobes 2; when the rear expansion gear knob 4 controls the start of the radiation source catheter lobes 2, the radiation source catheter lobes 2 will achieve continuous different opening angles according to the knob adjustment, so as to realize the multi-angle expansion of the radiation source catheter lobes 2 in the vagina; the structures of the above-mentioned several devices are not limited, and any structure that can achieve the above technical effects is acceptable.

[0036] In this embodiment, it is preferred that the rear expansion gear knob 4 is threadedly connected to the central radiation source catheter 1, and the up and down movement of the rear expansion gear knob 4 is adjusted by left and right thread rotation. The outer periphery of the rear expansion gear knob 4 is provided with anti-slip protrusions to increase the friction between the operator and this instrument, so as to facilitate the operator's precise control of the expansion degree.

[0037] In this embodiment, preferably, the linkage device 3 is provided with a slider 31, a connecting rod 32 and a support rod 33. The slider 31 is sleeved around the central radiation source catheter 1. A support rod 33 is hinged above the slider 31, and the support rod 33 is hinged to the middle and lower part of the radiation source catheter lobe 2, and can actively control the opening and closing angle of the radiation source catheter lobe 2 along with the up and down movement of the post-dilation gear knob 4. The connecting rod 32 is connected to the bottom of the slider 31 at the upper part and to the upper part of the post-dilation gear knob 4 at the lower part, and the rod body is placed in the groove 11 on the central radiation source catheter 1. The size of the groove 11 fits the size of the connecting rod 32 and can slide along with the upward movement of the dilation gear knob 4. A clamping groove 12 is provided at the lower part of the linkage device 3. The clamping groove 12 is provided on the central radiation source catheter 1 and is clamped to the bottom of the radiation source catheter lobe 2. The number of the clamping grooves 12 matches the number of the radiation source catheter lobes 2. Corresponding clamping bars 21 are also provided at the lower part of the radiation source catheter lobe 2 to facilitate clamping the clamping groove 12. The connection between the clamping bar 21 and the clamping groove 12 is a movable connection, so that the opening and closing of the radiation source catheter lobe 2 are not restricted.

[0038] In this embodiment, implanting needle holes 22 are provided on each of the radiation source catheter lobes. The implanting needle holes 22 are provided for inserting the guiding source implanting needles, and the size of the needle holes 22 should be adapted to the size of the implanting needles.

[0039] The usage method and principle of the present invention (taking cervical cancer as an example) are as follows:

[0040] The patient takes the lithotomy position. The radiotherapy medical team starts the applicator placement operation under the real-time guidance of the MRI image and ultrasound before afterloading radiotherapy. The nursing staff performs skin preparation and vaginal irrigation. The attending physician first performs routine disinfection and draping of the vulva. After inserting the speculum into the vagina to expose the cervix, disinfection of the cervix and vagina is carried out. Subsequently, the attending physician selects a suitable uterine cavity applicator tube, slowly pushes it along the uterine cavity direction through the cervical os to the uterine fundus, and confirms through the ultrasound image that the top of the applicator tube is closely attached to the uterine fundus. Immediately afterwards, the applicator of the present invention is inserted into the vagina. During the operation, the already placed uterine cavity applicator tube is inserted into the central radiation source catheter 1. At this time, the applicator is not opened, and each radiation source catheter lobe 2 presents a tightly combined state, which is convenient for the operator to insert into the vagina. After the applicator is stably placed, it is fixed by embedding the fixed handle 5 into the fixing device on the afterloading bed. Since the preoperative MRI indicates that the tumor invades the parametrium, it is necessary to combine implanting needles to enhance the local dose. Slowly control the post-dilation gear knob 4. Under the ultrasound guidance, expand the radiation source catheter lobe 2 to an appropriate angle, select the radiation source catheter lobe 2 at a suitable position, insert an implanting needle into the selected radiation source catheter lobe 2, and make the tip of the needle reach the center of the tumor. After the implantation is completed, the patient undergoes a CT positioning image scan, and target area delineation and subsequent radiotherapy plan design are performed on the obtained images. After the plan is reviewed and approved, the radiotherapy technician connects the radiation source to the guiding source tube preset in the patient's body and then performs irradiation.

[0041] It should be noted that the present invention is small in size and easy to be inserted. When the dilation is not activated, the applicator is small in size and can be easily inserted into the vagina, reducing the discomfort and pain of the patient. This design not only simplifies the operation process but also improves the comfort during the treatment; it can also precisely control the dilation form. The degree of dilation of the applicator can be flexibly adjusted through the external control keys, especially achieving different angles of dilation at the top end, and the amplitude is greater than that of the middle and rear sections. The top end can accurately reach the vaginal fornix and the cervix and extend laterally to the periphery, fully conforming to the individual anatomical structure, providing a more suitable radiation source channel form for radiotherapy, and also having personalized adaptation to radiotherapy needs. The lobed position of the radiation source catheter can be flexibly adjusted according to the specific radiotherapy plan of the patient to optimize the distribution shape of the applicator channel, maximizing the satisfaction of the treatment requirements. This feature significantly enhances the accuracy of target area coverage in the vaginal top and cervical regions, thereby improving the radiotherapy effect.

[0042] The above are only the preferred embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art of this technology, without departing from the principle of the present invention, several improvements and supplements can still be made, and these improvements and supplements should also be regarded as the protection scope of the present invention.

Claims

1. A multi-channel afterloading radiotherapy applicator for gynecological tumors with automatic after-expansion, comprising a central radiation source catheter, radiation source catheter leaves, a linkage device, a after-expansion gear knob, and a fixed handle, characterized in that: A central radiation source catheter is provided, a fixed handle is provided at the bottom of the central radiation source catheter, and the interior of the central radiation source catheter is hollow; a rear expansion gear knob is provided on the upper part of the fixed handle; the upper part of the rear expansion gear knob is connected to a linkage device; the linkage device and the rear expansion gear knob are both placed on the periphery of the central radiation source catheter; the rear expansion gear knob can control the linkage device to slide up and down on the periphery of the central radiation source catheter; a radiation source catheter leaf is provided on the linkage device; an implantation pinhole is provided on the radiation source catheter leaf; a plurality of radiation source catheter leaves are provided, and the plurality of radiation source catheter leaves can be dispersed or synthesized as the linkage device slides up and down, and different angles of the radiation source residence can be achieved by continuously adjusting the different angles of the radiation source catheter leaves, and the synthesis form of the radiation source catheter leaves is a cylinder.

2. The multi-channel afterloading radiotherapy applicator for gynecological tumors capable of automatic after-expansion according to claim 1 is characterized in that: The fixed handle is a cylindrical structure made of flexible material.

3. The multi-channel afterloading radiotherapy applicator for gynecological tumors capable of automatic after-expansion according to claim 1 is characterized in that: The rear expansion gear knob is threadedly connected to the central radiation source catheter, and the up and down movement of the rear expansion gear knob is adjusted by rotating the left and right threads.

4. The multi-channel afterloading radiotherapy applicator for gynecological tumors capable of automatic after-expansion according to claim 1 is characterized in that: The linkage device is provided with a slider, a connecting rod and a support rod. The slider is sleeved on the periphery of the central radiation source catheter. A support rod is hinged above the slider, and the support rod is hinged to the middle and lower part of the radiation source catheter leaf. The connecting rod is connected to the bottom of the slider at the top and the upper part of the rear expansion gear knob at the bottom, and the rod body is placed in a groove on the central radiation source catheter and can slide as the expansion gear knob moves upward.

5. The multi-channel afterloading radiotherapy applicator for gynecological tumors capable of automatic after-expansion according to claim 1 is characterized in that: A card slot is provided at the lower part of the linkage device. The card slot is provided on the central radiation source conduit and is clamped at the bottom of the radiation source conduit leaf. The number of the card slots matches the number of the radiation source conduit leaf.

6. The multi-channel afterloading radiotherapy applicator for gynecological tumors capable of automatic after-expansion according to claim 1 is characterized in that: The insertion needle hole size is adapted to the interpolation needle size.

7. The multi-channel afterloading radiotherapy applicator for gynecological tumors capable of automatic after-expansion according to claim 1 is characterized in that: An anti-skid protrusion is arranged on the outer periphery of the rear expansion gear knob.

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