Universal applicator for transvaginal parauterine implantation

Abstract

The present invention relates to the technical field of medical devices, specifically to a universal source applicator for transvaginal parauterine implantation, comprising a cylindrical source applicator body, a uterine cavity channel arranged in the direction of the central axis of the body; a needle insertion channel group is arranged on the body, the needle insertion channel group comprises a vertical needle insertion area and an oblique needle insertion area, a vertical channel arranged along the axial direction of the body is arranged in the vertical needle insertion area, the entrance end of the vertical channel is located on the lower end face of the body, and the central angle corresponding to the area where the entrance ends of the vertical channels converge is 60-90°; a side wall channel is arranged in the oblique needle insertion area, the side wall channel does not intersect with the vertical channel, the outlet of the side wall channel is located on the upper side wall of the body, and the outlet of the vertical channel is arranged on a side close to the outlet of the side wall channel. The present invention can solve the technical problem that the existing implantation needle is easily deviated when it is inserted into the tumor from the perineal tissue, thereby reducing the accuracy of the implantation needle penetrating the tumor area.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a universal source applicator for transvaginal parauterine implantation. Background Art

[0002] Radiotherapy is one of the main means of treating gynecological tumors (cervical cancer, vaginal cancer, endometrial cancer, etc.). Radical radiotherapy includes external radiation therapy (EBRT) and intracavitary afterloading radiotherapy. Intracavitary afterloading radiotherapy is irreplaceable. Intracavitary afterloading radiotherapy is used to further increase the radiation dose of the tumor to achieve a radical dose level, while reducing the dose to surrounding normal organs, further protecting normal tissues and reducing complications. The specific operation method of intracavitary afterloading therapy is: first place the applicator without a radioactive source into the uterine cavity or vagina, and then send the radioactive source from the source tank into the applicator through a pipe, and remotely control the radioactive source through a computer to reach the tumor area; clinically, the method of inserting an implant needle into the tumor is often used to provide a passage for the radioactive source, so as to accurately place the radioactive source in the cancerous tumor area, so that the radiation only affects a very limited area around the radioactive source, and reduces the radiation dose to normal tissues far away from the radioactive source.

[0003] The needle track on most existing applicators is parallel to the applicator body. The implant needle is inserted into the tumor in the cervix along the needle track. However, clinically, it is found that most cervical tumors are irregular, and the tumors can spread to the paracervical tissue and even reach the pelvic wall. Since this part of the tumor is located in a relatively biased position, it is difficult to use existing applicators for radiotherapy. The traditional treatment method is to use external irradiation boost, but external irradiation often cannot reach the radical dose and causes great damage to the surrounding normal tissue. Therefore, the commonly used method is to insert the implant needle from the perineum, and use this part of the implant needle to boost the paracervical tumor. Figure 1 As shown, for the tumor 200 growing in the cervix 101, it is irradiated and treated by an applicator, and for the tumor 200 that spreads to the paracervical tissue 102, it is necessary to use an additional implantation needle 300 for supplementary treatment. When the implantation needle 300 is inserted from the perineal tissue 100 into the tumor 200, the perineal tissue 100 has a certain resistance to the insertion of the implantation needle 300, which can easily cause the implantation needle 300 to deviate, reducing the accuracy of the implantation needle 300 inserting into the tumor 200 area. At the same time, directly inserting the implantation needle 300 from the perineal tissue 100 will also cause greater damage to the patient's perineal tissue 100 and normal paracervical tissue 102. Summary of the invention

[0004] The present invention aims to provide a universal source applicator for transvaginal parauterine implantation, which can solve the technical problem that the existing implantation needle is easily deviated when inserted into the tumor through the perineal tissue, thereby reducing the accuracy of the implantation needle entering the tumor area.

[0005] In order to achieve the above object, the present invention adopts the following technical scheme:

[0006] A universal applicator for transvaginal parauterine implantation comprises a cylindrical applicator body, a uterine cavity channel is arranged in the direction of the central axis of the body; a pin insertion channel group is arranged on the body, the pin insertion channel group comprises a vertical pin insertion area and an oblique pin insertion area, a vertical channel is arranged in the vertical pin insertion area and is arranged along the axial direction of the body, the inlet end of the vertical channel is located on the lower end face of the body, and the central angle corresponding to the area where the inlet ends of the vertical channels converge is 60-90°; a side wall channel is arranged in the oblique pin insertion area, the side wall channel does not intersect with the vertical channel, the outlet of the side wall channel is located on the upper side wall of the body, and the outlet of the vertical channel is arranged on a side close to the outlet of the side wall channel.

[0007] The principles and beneficial effects of this solution are:

[0008] 1. This scheme sets up vertical and oblique needle insertion areas. When in use, the insertion needles can be placed in the vertical and oblique needle insertion areas according to the location of the tumor, thereby achieving radiotherapy for tumors inside and around the cervix, ensuring that the radiotherapy can reach the required dose, and providing a possibility for close-range radiotherapy of paracervical tumors.

[0009] 2. The inventors have studied a large number of clinical cases and discovered the location where parametrial tumors are prone to grow, namely, the area where the entrances or exits of the vertical channels converge. This area is fan-shaped, and its corresponding central angle is 60-90°. Since the side wall channel and the vertical channel are located on the same side of the center of the main body, the exit end of the insertion needle inserted from the side wall channel is located in the fan-shaped area. Inserting the insertion needle from this area can perform close-range treatment on more than 90% of parametrial tumors; when the side wall channel and the vertical channel are not on the same side of the center of the main body, the insertion ranges of the vertical channel and the side wall channel are separated, but in actual practice, the tumor always extends from the cervix to the parametrial, that is, the growth area of ​​the tumor is usually continuous. If the insertion ranges of the vertical channel and the side wall channel are separated, some tumors will always be unable to obtain the required radiation dose.

[0010] 3. When the central angle of the corresponding fan-shaped area is less than 60°, when the parauterine tumor is located outside this area, it is difficult to ensure accurate radiotherapy for this part of the tumor. The dose of the radiation source can only be increased on the basis of the original implant needle. However, since the radiation source is a point source, when the dose increases, the radiation area of ​​the radiation source increases (the radiation area is always a circular area), which will cause damage to the surrounding normal tissues; when the central angle of the corresponding fan-shaped area is greater than 90°, when the implant needle is inserted from the boundary of the fan, it will cause damage to the patient's bladder and rectum to a great extent.

[0011] 4. During use, the side wall channel and the vertical channel cannot intersect. When they intersect, the inserted implant needles will also intersect. On the one hand, it is difficult for the intersecting implant needles to pass through the intersection of the channels. On the other hand, the intersection of the implant needles will cause the radiation source to be unable to select the normal radiation path, which will lead to procedural failures and cause the termination of radiotherapy.

[0012] In summary, the inventor sets the insertion range of the needle channel group to be the same as the tumor area. The doctor can select a specific needle channel according to the tumor area, thereby increasing the accuracy of the insertion of the needle into the tumor by at least 10%. Compared with setting the insertion channel on the entire applicator, the present application is more suitable for clinical radiotherapy. When used, it can effectively reduce the doctor's choices and reduce the cognitive resources occupied by the doctor during insertion, thereby reducing the difficulty of operating technology, improving the insertion efficiency, and at the same time improving the accuracy and reducing the psychological and physiological harm to the patient.

[0013] Preferably, as an improvement, a plurality of needle-compensating channels are provided in the vertical needle insertion area, and the vertical channels and the needle-compensating channels are distributed outward in sequence along the radial direction of the main body, and the distance between the center of the needle-compensating channel and the center of the main body is greater than the distance between the circle of the vertical channel and the center of the main body, and the distance between adjacent vertical channels or needle-compensating channels in the same radial direction is equal.

[0014] Beneficial effects: Since the radiation source is a point source, the irradiation range expands as its residence time increases during treatment. The radiation range is a regular circle, while the tumor is generally irregular in shape. By setting a supplementary needle channel outside the vertical channel, and the distance between the center of the supplementary needle channel and the center of the main body is greater than the distance between the vertical channel circle and the center of the main body, at least two layers of channels are set up, which can well achieve the compensation and superposition of the radiation source dose, so that the treatment reaches the required dose, and can effectively reduce the damage to the normal tissue around the tumor.

[0015] Preferably, as an improvement, the outlet ends of the side wall channels are arranged in layers from top to bottom, the vertical distance between the outlet ends of each layer of the side wall channels is equal, and the horizontal distance between the outlet ends of adjacent implant needles inserted by the same row of side wall channels is 1-2 cm. The centers of adjacent vertical channels in the same radial direction are 1-2 cm apart, and the centers of adjacent supplementary needle channels in the same radial direction are 1.5-3 cm apart.

[0016] Beneficial effects: Since the radiation dose for each time is fixed and the radiation range of the radiation source is regular, the center distances between adjacent side wall channels, vertical channels and supplementary needle channels are limited so that adjacent center distances are set at equal distances, which makes it easier for doctors to calculate the radiation dose during actual operation and further improves the accuracy of needle insertion; if the same type of implantation channels are not equidistant, the source applicator template will be chaotic and disordered for the doctor, which will reduce the doctor's accuracy of implantation and increase the damage to the patient.

[0017] Preferably, as an improvement, the side wall channel comprises a straight needle channel or a curved needle channel.

[0018] Beneficial effect: By setting the side wall channel as a straight needle channel or a curved needle channel, it is convenient for doctors to choose to use one of them according to the patient's condition, further improving the practicality of the applicator and making it suitable for the general public.

[0019] Preferably, as an improvement, the bending needle channel includes an oblique channel and a vertical channel located inside the main body, and the curvature of the connection between the oblique channel and the vertical channel is less than 1, or the bending angle of the bending needle channel is 130-140°.

[0020] Beneficial effects: By setting the bending angle of the side wall channel within the above-mentioned range, the path of the implant needle penetrating into the tumor area can be further shortened, the accuracy of insertion can be improved, and damage to the patient's normal tissue can be reduced; by setting the curvature of the connection between the oblique channel and the vertical channel to be less than 1, the smoothness of the curved needle insertion into the curved part can be further improved.

[0021] Preferably, as an improvement, the outlet and the inlet of the straight needle channel are respectively located on both sides of the central axis of the body, and the inclination angle between the central axis of the straight needle channel and the horizontal plane is 50-70°.

[0022] Beneficial effect: When the implant needle is inserted from the side wall channel, more area of ​​the implant needle is located in the source device body, and less area penetrates into the tumor area from normal tissue, which can effectively reduce the path of the implant needle penetrating into the human body, alleviate the patient's pain, and reduce damage to the patient's normal tissue.

[0023] Preferably, as an improvement, the diameters of the vertical channel, the needle-filling channel and the side wall channel are 1.5-2.5 mm.

[0024] Beneficial effects: ensure that the implant needle does not deviate when inserted into the channel, improve the accuracy of the implant needle penetrating the tumor, and further reduce the error caused by the implant path.

[0025] Preferably, as an improvement, there are two groups of pin channel groups, and the two groups of pin channel groups are located on both sides of the center of the body, and the side wall channels in the two groups of pin channel groups do not intersect.

[0026] Beneficial effects: By setting up two groups of needle channel groups, it is possible to use one applicator to perform radiotherapy on tumors in the cervix and paracervical tumors that have spread to the left and right sides of the cervix. It is also possible to selectively insert needles into any one of the two needle channel groups according to the patient's condition, so that the applicator can be suitable for a wider range of people, while reducing the difficulty of needle insertion for doctors and generally improving the accuracy of radiotherapy for cervical and paracervical tumors. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a schematic diagram of the use of the source applicator in the prior art;

[0028] Figure 2 This is a physical picture of the growth of a paracervical tumor;

[0029] Figure 3 It is a three-dimensional schematic diagram of the source applicator of the present invention;

[0030] Figure 4 A top view of the source applicator of the present invention;

[0031] Figure 5 A bottom view of the source applicator of the present invention;

[0032] Figure 6 is a side view of the source applicator of the present invention;

[0033] Figure 7 This is a schematic diagram of the use of embodiment 1;

[0034] Figure 8 This is a schematic diagram of the use of the second embodiment. DETAILED DESCRIPTION

[0035] The following is further described in detail through specific implementation methods:

[0036] The marks in the drawings of the specification include: main body 1, uterine cavity channel 10, vertical channel 11, supplementary needle channel 12, side wall channel 13, curved needle channel 131, straight needle channel 132, perineal tissue 100, cervix 101, paracervix 102, tumor 200, implant needle 300, insertion point 301, inclination angle a, bending angle b.

[0037] Embodiment 1

[0038] like Figure 2As shown in FIG. 1 , the figure is a physical picture of a tumor growing in the cervix and paracervix, wherein the shadow in the middle of the figure is the tumor, the bladder is above the tumor, the distance between the center of the cervix and the bladder is L, and the length is 1.25 cm. It can be seen that tumors growing in the cervix and paracervix are often very close to normal organs around the human body, so it is necessary to be precise during radiotherapy to reduce damage to normal tissues of the patient and alleviate the patient's pain. In order to achieve the above purpose, this embodiment discloses a method as follows: Figure 3 The universal applicator for transvaginal parauterine implantation shown in the figure comprises a cylindrical applicator body, the diameter of the body 1 is 2-3.5 cm, and the length is 6-8 cm. In the present embodiment, the diameter of the body 1 is 3 cm, and the length is 6 cm. A uterine cavity channel 10 is arranged in the central axis direction of the body 1. In the present embodiment, the diameter of the uterine cavity channel 10 is 5 mm; a needle insertion channel group is arranged on the body 1, and the needle insertion channel group comprises a vertical needle insertion area and an oblique needle insertion area. A vertical channel 11 is arranged along the axial direction of the body 1 in the vertical needle insertion area. The inlet end of the vertical channel 11 is located on the lower end surface of the body 1. The central angle corresponding to the area where the inlet ends of the vertical channels 11 converge is 60-90°. In the present embodiment, the central angle is 60°. Figure 4-5 As shown in β; a side wall channel 13 is provided in the oblique needle insertion area, the side wall channel 13 does not intersect with the vertical channel 11, the outlet of the side wall channel 13 is located on the upper side wall of the body 1, and the outlet of the vertical channel 11 is located on the side close to the outlet of the side wall channel 13 (that is, when the implantation needle 300 is inserted from the side wall channel 13, the insertion point 301 of the implantation needle 300 is located in the fan-shaped area corresponding to the vertical channel 11, as shown in FIG. Figure 4 shown).

[0039] like Figure 3-5 As shown, a plurality of complementary needle channels 12 are further provided in the vertical needle insertion area, and the vertical channels 11 and the complementary needle channels 12 are arranged in rows outwardly along the radial direction of the main body 1, and the distance between the center of the circle of the complementary needle channel 12 and the center of the main body 1 is greater than the distance between the circle of the vertical channel 11 and the center of the main body 1; optimally, in this embodiment, the vertical channels 11 and the complementary needle channels 12 are each in a row, wherein three vertical channels 11 form a row, and four complementary needle channels 12 form a row; the center of each vertical channel 11 is 1 cm away from the center of the main body 1, and the center of each complementary needle channel 12 is 1.5 cm away from the center of the main body 1. In other embodiments other than this embodiment, the vertical channels 11 can be arranged in multiple rows, so that the acupuncture area is wider, and the distances between adjacent rows of vertical channels 11 are equal; similarly, the supplementary needle channels 12 can also be arranged in multiple rows, and the distances between adjacent rows of supplementary needle channels 12 are equal, so that the doctor can calculate the dose of the radiation source during actual operation to ensure that all locations of the tumor receive radiotherapy and that the radiation dose reaches the required amount; it is worth noting that the set channels still need to be ensured to be within the range corresponding to the aforementioned central angle β.

[0040] like Figure 6 As shown, the outlet ends of the side wall channels 13 are all located on the side wall of the body 1, and are arranged in rows and layers from top to bottom. The vertical distance between the outlet ends of each layer of the side wall channels 13 is equal, and the horizontal distance between the outlet ends of adjacent implant needles 300 inserted by the same row of side wall channels 13 is 1-2 cm, and 1 cm in this embodiment; Figure 7 As shown, the side wall channel 13 of this embodiment is a curved needle channel 131, and the curved needle channel 131 is in three rows, each row has three channels. Specifically, the curved needle channel 131 includes an oblique channel and a vertical channel located inside the body 1, and the curvature of the oblique channel and the vertical channel at the connection is less than 1, or the bending angle b of the curved needle channel 131 is 130-140°. In this embodiment, the bending angles b of the three groups of curved needle channels 131 are 130°, 135°, and 140°, respectively. Specifically, the diameters of the vertical channel 11, the supplementary needle channel 12, and the side wall channel 13 are 1.5-2.5 mm, and the diameter of each channel in this embodiment is 1.5 mm.

[0041] The specific implementation process is as follows: first, the source applicator body is inserted from the patient's perineal channel so that the front end of the body 1 is located at the cervix 101, and then the patient's cervix 101 and paracervix 102 are scanned by CT to confirm the location of the tumor 200, and then one or more channels in the vertical needle insertion area and the oblique needle insertion area are selected to insert the implantation needle 300 according to the location of the tumor 200. In this process, only the channel needs to be selected without evaluating the angle of insertion of the implantation needle 300, which can effectively reduce the offset after insertion and improve the accuracy of the implantation needle 300 penetrating the tumor 200, which is very suitable for clinical radiotherapy. After the implantation needle 300 is determined, the radiation source is first allowed to reach the tumor 200 area from the uterine cavity channel 10, and then the radiation source is allowed to reach the tumor 200 area of ​​the paracervix 102 from the implantation needle 300. In this process, the residence time of the radiation source is selected according to the size of the tumor 200 to ensure that the radiation source reaches the required dose.

[0042] To sum up, the number of insertion channels on the applicator in this embodiment is the optimal choice, which can meet the treatment principle of using the least number of insertion needles 300, and the use of the applicator of the present invention can not only ensure that each part of the cervical 101 tumor 200 receives the radiation dose required for treatment, but also improve the accuracy of inserting the insertion needle 300 into the paracervical 102 tumor 200, reduce the technical difficulty of the paracervical 102 insertion operation, reduce the damage of the radiation source and the insertion needle 300 to the patient's normal tissue, and ensure the treatment effect at the same time.

[0043] Embodiment 2

[0044] The difference between this embodiment and the first embodiment is that Figure 8As shown, the side wall channel 13 is a straight needle channel 132; specifically, the outlet and the inlet of the straight needle channel 132 are respectively located on both sides of the central axis of the main body 1, and the inclination angle a between the central axis of the straight needle channel 132 and the horizontal plane is 50-70°, and the specific inclination angles a of the three groups of straight needle channels 132 are 50°, 60°, and 70°, respectively; in this embodiment, the inlet ends of the straight needle channels 132 are all located on the lower side wall of the main body 1, which is convenient for doctors to quickly distinguish the entrances of the vertical channel 11 and the side wall channel 13 during actual operation. In other embodiments other than this embodiment, the inlet end of the straight needle channel 132 can also be set on the end of the main body 1.

[0045] Embodiment 3

[0046] The difference between this embodiment and the first and second embodiments is that there are two needle channel groups, and the two needle channel groups are located on both sides of the center of the body 1, and the side wall channels 13 in the two needle channel groups do not intersect. By setting two needle channel groups, it is possible to use one applicator to perform radiotherapy on the tumor 200 in the cervix 101 and the paracervical 102 tumor 200 that spreads to the left and right sides of the cervix 101, and it is also possible to choose to insert needles into any one of the two needle channel groups according to the patient's condition, so that the applicator can be applied to a wider range of people, while reducing the difficulty of needle insertion for doctors, and generally improving the accuracy of radiotherapy for the cervix 101 and paracervical 102 tumors 200.

[0047] The above is only an embodiment of the present invention, and the common knowledge such as the known specific technical solutions and / or characteristics in the solution is not described in detail here. It should be pointed out that for those skilled in the art, without departing from the technical solution of the present invention, several modifications and improvements can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A universal applicator for transvaginal parauterine implantation, comprising a cylindrical applicator body, a uterine cavity channel being arranged in the central axis direction of the body, characterized in that: The main body is provided with a pin channel group, which includes a vertical pin area and an oblique pin area. The vertical pin area is provided with a vertical channel that is arranged to penetrate the main body axially. The inlet end of the vertical channel is located on the lower end surface of the main body, and the central angle of the area where the inlet ends of the vertical channels converge is 60-90°, and the area is fan-shaped; the oblique pin area is provided with a side wall channel, the side wall channel does not intersect with the vertical channel, the outlet of the side wall channel is located on the upper side wall of the main body, and the outlet of the vertical channel is arranged on a side close to the outlet of the side wall channel, and the outlet end of the implant needle inserted from the side wall channel is located in the fan-shaped area; A plurality of needle-supplementing channels are also provided in the vertical needle insertion area, and the vertical channels and the needle-supplementing channels are sequentially distributed outwardly along the radial direction of the main body, and the distance between the center of the needle-supplementing channel and the center of the main body is greater than the distance between the circle of the vertical channel and the center of the main body, and the distances between adjacent vertical channels on the same row of vertical channels that are equal to the center of the main body are equal, and the distances between adjacent needle-supplementing channels on the same row of vertical channels that are equal to the center of the main body are equal; the outlet ends of the side wall channels are sequentially layered from top to bottom, the vertical distances between the outlet ends of the side wall channels of each layer are equal, and the horizontal distance between the outlet ends of adjacent implant needles inserted by the same column of side wall channels is 1-2 cm.

2. The universal applicator for transvaginal parauterine implantation according to claim 1, characterized in that: The center of each vertical channel is 1 cm away from the center of the body, and the center of each supplementary needle channel is 1.5 cm away from the center of the body.

3. The universal applicator for transvaginal parauterine implantation according to any one of claims 1 to 2, characterized in that: The side wall channel includes a straight needle channel or a curved needle channel.

4. The universal applicator for transvaginal parauterine implantation according to claim 3, characterized in that: The curved needle channel includes an oblique channel and a vertical channel located inside the body, and the curvature of the connection between the oblique channel and the vertical channel is less than 1, or the bending angle of the curved needle channel is 130-140°.

5. The universal applicator for transvaginal parauterine implantation according to claim 4, characterized in that: The outlet and the inlet of the straight needle channel are respectively located on both sides of the central axis of the body, and the inclination angle between the central axis of the straight needle channel and the horizontal plane is 50-70°.

6. The universal applicator for transvaginal parauterine implantation according to claim 5, characterized in that: The diameters of the vertical channel, the needle-filling channel and the side wall channel are 1.5-2.5 mm.

7. The universal applicator for transvaginal parauterine implantation according to claim 1, characterized in that: There are two groups of pin channel groups, and the two groups of pin channel groups are located on both sides of the center of the body, and the side wall channels in the two groups of pin channel groups do not intersect.

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