Brachytherapy source application device convenient to insert and plant

By designing a close-range treatment source application device that is convenient for implantation, and using preset implantation channels and implantation needle kits, the problems of difficulty in implantation and poor treatment effects in patients with middle and late cervical cancer are solved, and the convenience and accuracy of implantation are achieved, and the accuracy and effect of treatment are improved.

CN222657621UActive Publication Date: 2025-03-25ANHUI PROVINCIAL HOSPITAL
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Patent Information

Application Number
CN202420948557.7
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-04-30
Publication Date
2025-03-25
Estimated Expiration
2034-04-30

AI Technical Summary

Technical Problem

The existing close-range treatment technology has problems such as difficulty in implanting needle implant kits, patient injury, insufficient implant accuracy and poor treatment effect in patients with middle and advanced cervical cancer.

Method used

A close-range therapeutic source application device for easy implantation is designed, including an implant sleeve implanted into the upper part of the cervical mouth. The sleeve is equipped with a uterine cavity canal and an adjustable fixing ring entering the uterine cavity. It is equipped with a multiple spiral implant channels and a needle implant kit inside. These structures are used to facilitate the precise implantation and adjustment of the needle implant kit.

Benefits of technology

The device achieves convenient and precise implantation of the implantation kit through preset implantation channels and implantation kit, overcomes implantation difficulties caused by factors such as vaginal stenosis and large parauterine tumors, and improves the accuracy and effect of treatment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model discloses a brachytherapy source application device convenient to insert and plant, and particularly relates to the technical field of medical treatment, the brachytherapy source application device comprises an insert and plant sleeve, a uterine cavity tube is inserted in the middle of the insert and plant sleeve, and a fixing ring is sleeved in the middle of the insert and plant sleeve; a planting channel is formed in the planting sleeve, and a planting needle suite is placed in the planting channel; the two ends of the planting channel are provided with a planting inlet and a planting outlet respectively, the planting inlet is located in the end face of the planting sleeve, and the planting outlet is located in the side face of the planting sleeve; and the transplanting channel is arranged to be in a spiral shape. According to the utility model, the implanting channel beside the guide grid is pre-arranged in the implanting sleeve, so that the implanting needle suite pre-arranged in the implanting channel is convenient to implant; and the preset implanting channel is designed in an accurate direction changing manner, so that the implanting needle suite is more convenient and accurate to adjust, and the application range is wide.
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Description

Technical Field

[0001] The utility model relates to the field of medical technology, and more specifically to a close-range treatment source device which is convenient for implantation. Background Art

[0002] It is known that cervical cancer is a common malignant tumor in women, and brachytherapy is an indispensable local tumor boosting radiotherapy technology for the treatment of mid- and late-stage cervical cancer, which has irreplaceable therapeutic advantages. Since cervical cancer above stage IIB is mainly treated with radical radiotherapy and chemotherapy, and in clinical practice, many local advanced cervical cancers cannot completely regress after external irradiation therapy. For example, for patients with paracervical invasion or large masses, due to the particularity of their cervical structure, cervical cancer tumors have a significant tendency to expand laterally during progression, and conventional brachytherapy, i.e., a pear-shaped combined intracavitary application therapy of one uterine cavity tube plus two application tubes, is a common treatment option. The dose line coverage is limited, and it is difficult to achieve dose coverage of irregular target areas, which can easily cause missed irradiation of paracervical tumors. According to clinical data, about 42% of patients with advanced cervical cancer who received traditional three-tube treatment had tumor missed irradiation. Therefore, the existing technology generally adopts intracavitary combined with interstitial implantation technology to target such situations as poor tumor regression after external irradiation, large residual tumor volume, irregular shape, and paracervical involvement. By directly implanting the implant needle kit into the tumor, the ideal dose coverage of the target area can be ensured while significantly reducing the dose to the endangered organs.

[0003] Although the choice of treatment mode and source channel type plays a decisive role in the effect of brachytherapy, there are several problems in actual clinical use:

[0004] 1. Due to the poor vaginal conditions of patients with advanced stage disease after external irradiation, the existing applicators are mostly customized for the physiological structure of European and American women, which are large in size and easily cause physical discomfort to patients, resulting in the inability of the implant needle kit to be accurately implanted through the vault into the infiltrated paracervix, affecting the distribution of radiotherapy dose;

[0005] 2. With limited vaginal width, the implantation angle of the implant needle kit is limited, so that tumors with a large parauterine infiltration range cannot be effectively implanted, and the ideal coverage of the target dose cannot be achieved;

[0006] 3. The existing technical means require doctors to conduct multiple CT scans to evaluate the implantation effect, and then manually adjust the position and angle of the implanted applicator and implant needle kit repeatedly, which lacks a convenient and accurate adjustment method;

[0007] 4. Limited by existing hardware conditions, doctors in China often perform manual implantation. However, due to the patient's own condition and operating experience, the implantation needle kit may not be implanted in the ideal position, or the intervals between needle channels may be different, resulting in hot and cold spots in the dose, which in turn affects the treatment effect. At the same time, after the initial implantation, doctors need to repeatedly adjust the implantation depth and angle under CT guidance, which brings a lot of pain to the implanted patients.

[0008] 5. Although the 3D-printed vaginal applicator meets the individualized treatment requirements of patients, it has defects such as high printing material requirements, high treatment costs, and insufficient adjustability. At the same time, given the high cost and long production cycle of 3D-printed phantoms, the pressure of clinical promotion is high and it is difficult to popularize it.

[0009] In view of the limited clinical application of this type of brachytherapy technology with implantation, there is an urgent need to establish a set of comprehensive, convenient and accurate brachytherapy source devices. Therefore, a brachytherapy intrauterine implantation source device that is easy to implant is proposed as a further improvement to maximize the local irradiation capability of the target area of ​​brachytherapy, improve the local control rate of tumors, and effectively improve the survival rate of patients with mid- and late-stage cervical cancer. Utility Model Content

[0010] In order to overcome the above-mentioned defects of the prior art, an embodiment of the present utility model provides a close-range treatment source device that is easy to implant, so as to solve the problems raised in the above-mentioned background technology.

[0011] To achieve the above-mentioned purpose, the utility model provides the following technical solutions: a close-range treatment source device convenient for implantation, the source device comprising: an implantation sleeve implanted in the upper part of the cervical os, a uterine cavity tube entering the uterine cavity is inserted in the middle of the implantation sleeve, and a fixing ring is adjustable and fixedly sleeved in the middle of the implantation sleeve;

[0012] A plurality of implantation channels are provided inside the implantation sleeve, and an implantation needle kit is placed inside the implantation channel;

[0013] The two ends of the implantation channel are respectively arranged as an implantation inlet and an implantation outlet, a number of the implantation inlets are located on the end surface of the implantation sleeve, and a number of the implantation outlets are located on the side surface of the implantation sleeve; one end of the implantation needle kit is passed through the implantation inlet;

[0014] The shape of the implantation channel is set to be a spiral shape.

[0015] Furthermore, channel markings are provided at both ends of the implantation channel.

[0016] Furthermore, the diameter of the implantation channel is greater than the diameter of the implantation needle kit.

[0017] Furthermore, a plurality of the implantation inlets are evenly distributed on the end surface of the implantation sleeve, and a plurality of the implantation outlets are evenly distributed on the side surface of the implantation sleeve.

[0018] Furthermore, the distance between the plurality of implantation channels is set at 0.5-1.5 cm.

[0019] Technical effects and advantages of the utility model:

[0020] 1. Compared with the prior art, the implantation sleeve is designed to be inserted into the designated cervical position, and the implantation sleeve is provided with an implantation channel guiding the paracervix and an implantation needle kit pre-buried in the implantation channel, so as to facilitate the implantation of the implantation needle kit into the designated position; fundamentally overcoming the problems of difficulty in implantation of the source channel and the implantation needle kit, patient injury, and insufficient implantation accuracy caused by factors such as narrow vagina of the patient, large paracervical tumor, and doctor's implantation puncture experience; and the preset implantation channel is a precise change of direction design, so the adjustment of the implantation needle kit is more convenient, and the implantation direction and depth of the implantation needle kit are more accurate; and the preset implantation channel in the implantation sleeve forms a multi-layer implantation channel, which is suitable for a wider range of people.

[0021] 2. The implantation sleeve of the utility model realizes the preliminary implantation of the implantation needle kit simultaneously with the implantation of the uterine cavity tube, thereby reducing the difficulty and risk of implantation at the vault; therefore, under the limited vaginal width, the implantation needle kit can utilize the implantation channels with multiple implantation angles; the effective implantation of the implantation needle kit enables the tumor with a larger parauterine infiltration area to be effectively treated, thereby achieving the ideal coverage of the target dose; and the source application device designed in the utility model changes the need for doctors to conduct multiple CT scans to evaluate the implantation effect, and saves the operating steps that require manual repeated adjustment of the position and angle of the implantation sleeve and the implantation needle kit. Therefore, the utility model has a convenient and precise adjustment method, and is practical and creative. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a schematic diagram of the structure of the utility model without the implant needle kit.

[0023] Figure 2 It is a schematic diagram of part of the internal structure of the implant sleeve of the utility model.

[0024] Figure 3 It is a structural schematic diagram of the implantation needle kit of the utility model being located in the implantation sleeve.

[0025] Figure 4 This is a schematic diagram of the source application device of the utility model being implanted into the uterine cavity.

[0026] Figure 5 It is a schematic diagram of several implant needle kits of the utility model.

[0027] The accompanying drawings are marked as follows:

[0028] 1. Insertion sleeve;

[0029] 11. implantation channel; 111. implantation inlet; 112. implantation outlet;

[0030] 12. Implant needle kit;

[0031] 2. Uterine tube;

[0032] 3. Fixed ring. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical solution and advantages of the utility model more clear, the utility model is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the utility model and are not used to limit the utility model.

[0034] As attached Figure 1-5 The illustrated embodiment is a brachytherapy source device convenient for implantation, the source device comprising: an implantation sleeve 1 implanted in the upper part of the cervical os, a uterine cavity tube 2 inserted into the uterine cavity is inserted in the middle of the implantation sleeve 1, and a fixing ring 3 is adjustable and fixedly sleeved in the middle of the implantation sleeve 1;

[0035] The center of the implant sleeve 1 can be inserted and fixed into the uterine cavity tube 2 of the patient's uterus;

[0036] The fixing ring 3 can be made of silicone material so that the fixing ring 3 can be adjusted on the implantation sleeve 1, and will not easily slide after the position is determined, so as to ensure that when the implantation sleeve 1 and the fixing ring 3 are implanted in the uterine cavity, the fixing ring 3 can prevent the implantation sleeve 1 from being implanted too deeply;

[0037] After the uterine cavity tube 2 is inserted into the implantation sleeve 1, the implantation depth can be determined by using a conventional anti-slip plug to fix the uterine cavity tube 2 and the implantation sleeve 1 into one body, thereby preventing the uterine cavity tube 2 from being implanted too deeply;

[0038] A plurality of implantation channels 11 are provided inside the implantation sleeve 1, and an implantation needle kit 12 is placed inside the implantation channel 11;

[0039] Both ends of the implantation channel 11 are respectively provided as an implantation inlet 111 and an implantation outlet 112, a plurality of implantation inlets 111 are located on the end surface of the implantation sleeve 1, and a plurality of implantation outlets 112 are located on the side surface of the implantation sleeve 1;

[0040] Among them, one end of the implant needle kit 12 is inserted into the implant channel 11 from the implantation port 111. Since the implant needle kit 12 is longer than the implantation channel 11, the excess portion is located outside the implantation channel 11, and the tail of the implant needle kit 12 is designed with a scale to facilitate understanding of the implantation depth of the implant needle kit 12;

[0041] The shape of the implantation channel 11 is set to be a spiral shape.

[0042] Among them, the insertion channel 11 has a spiral shape, and the insertion needle kit 12 can be implanted from the insertion port 111 on the end face of the insertion sleeve 1, and pass through the insertion port 112 on the side of the insertion sleeve 1 along the insertion channel 11, and then implanted inside the parauterine tumor. This device not only helps to adjust the insertion angle and improve the accuracy of implantation, but also facilitates the precise control of the amount of close-range treatment;

[0043] Among them, the size of the implant needle kit 12 needs to match the implant channel 11 opened by the implant sleeve 1, one-to-one correspondence, to avoid shaking or implantation difficulties; the top of the implant needle kit 12 is a metal hard tip to facilitate implantation into human tissue; the main body of the implant needle kit 12 is hollow, bendable, and has a length scale mark; it meets the requirements of the sleeve channel for bending and changing directions, and at the same time needs to have a certain toughness, and its length cannot be compressed or extended by external force to ensure the accuracy of the implant size;

[0044] Embodiment of implantation channel 11:

[0045] For example, the insertion ports 111 on the end surface of the insertion sleeve 1 are distributed in a cross shape, which are represented by a clock reference system as follows: 3 o'clock, 6 o'clock, 9 o'clock, and 12 o'clock;

[0046] If there are five insertion inlets 111 at intervals of 1 cm in the 3 o'clock direction of the uterine cavity tube 2 , then the corresponding five insertion outlets 112 at intervals of 2 cm are on the top surface of the insertion sleeve 1 .

[0047] Among them, the implantation sleeve 1 of the utility model is implanted synchronously with the uterine cavity tube 2, that is, a reserved position is provided for implantation of the implantation needle kit 12, thereby reducing the difficulty and risk of implantation at the vault; therefore, under the limited vaginal width, the implantation needle kit 12 can utilize the implantation channels 11 with multiple implantation angles; and for tumors with larger infiltration, more implantation needle kits 12 can be effectively implanted, so that tumors with larger parauterine infiltration can be effectively implanted, thereby achieving ideal coverage of the target dose;

[0048] Among them, the uterine cavity tube 2 is responsible for the intrauterine cavity administration; and the cervical administration is generally achieved by applying two tubes or a source ring;

[0049] Among them, the mushroom head at the end of the conventional source device is placed at the vaginal fornix, and there is an implantation needle channel on it, and then the implantation needle attached to the application tube or the implantation needle on the source ring is used to insert it into the tumor invading the parauterine part;

[0050] The utility model is a practical source application device. The central hole of the implantation sleeve 1 can provide a channel for the uterine cavity tube 2. The implantation channel 11 inside the implantation sleeve 1 guides the implantation needle kit 12 to the side of the implantation sleeve 1, so as to perform close-range treatment on the tumor beside the uterus, thereby overcoming the limitation of the existing intrauterine combined with close-range treatment technology of transperineal or transvaginal-vault implantation, and fundamentally overcoming the problems of difficulty in implanting the source application channel and the implantation needle kit 12, patient injury, and insufficient implantation accuracy caused by factors such as the patient's narrow vagina, large parauterine tumor, and doctor's implantation puncture experience; it avoids the poor vaginal conditions of most patients, the large commercial dressing tube / ring applicator, and the inability to implant it into the ideal position, thereby avoiding the inability of the implantation needle kit 12 to be accurately implanted into the infiltrated parauterus through the vault position.

[0051] In a preferred embodiment, as shown in the attached Figure 1-5 As shown, both ends of the implantation channel 11 are provided with channel markings, so that the implantation channel 11 can be distinguished by the channel markings, thereby facilitating the corresponding implantation needle kit 12 to be inserted into the corresponding implantation channel 11;

[0052] The channel mark of each implantation channel 11 records the depth, which is convenient for controlling the insertion depth of the implantation needle kit 12.

[0053] In a preferred embodiment, as shown in the attached Figure 1-5 As shown, the diameter of the implantation channel 11 is larger than the diameter of the implantation needle kit 12;

[0054] The diameter of the implantation channel 11 is 0.5-1.5 mm larger than the diameter of the implantation needle kit 12, so that the use of the implantation channel 11 will not affect the insertion of the implantation needle kit 12, and the difference between the two should not be too large to prevent the implantation needle kit 12 from shaking;

[0055] Among them, the common implant needle kit 12 has a diameter of 1.5-2 mm;

[0056] In a preferred embodiment, as shown in the attached Figure 1-5 As shown, a plurality of implantation inlets 111 are evenly distributed on the end surface of the implantation sleeve 1, and a plurality of implantation outlets 112 are evenly distributed on the side surface of the implantation sleeve 1;

[0057] Among them, a plurality of implantation channels 11 form a multi-layer implantation channel design; and the implantation channel 11 can accurately change direction and depth.

[0058] In a preferred embodiment, as shown in the attached Figure 1-5As shown, the distance between the plurality of implantation channels 11 is set at 0.5-1.5 cm, so as to fix the spacing of the implantation needle kits 12 implanted in the implantation channels 11 within a specified range, thereby avoiding uneven hot and cold doses that may occur during manual implantation.

[0059] A method for using a brachytherapy source device that is convenient for implantation includes a brachytherapy source device that is convenient for implantation, and the specific operation steps are as follows:

[0060] Step 1: After placing the patient in the lithotomy position, the doctor uses a vaginal speculum and uterine probe to assess the patient's vaginal and cervical conditions and detect the depth of the patient's uterine cavity;

[0061] Among them, detecting the depth of the patient's uterine cavity can provide reference data for the doctor, so that the doctor can choose the uterine cavity tube 2 and the implantation sleeve 1 of the appropriate size for the patient; for example, if the patient's uterine cavity depth is detected to be 5 cm, then it is determined that the effective implantation depth of the cervical canal 2 needs to be 5 cm, and the width of the cervical position is generally 2 cm-3.5 cm. If it is measured to be 3 cm, it is recommended to select an implantation sleeve 1 with a diameter of 3 cm;

[0062] The implantation channel 11 of the implantation sleeve 1 has different depths, such as 2 cm, 3 cm, and 4 cm.

[0063] Step 2: Based on the patient's pre-treatment diagnostic images, assess the patient's paracervical infiltration range, select the implantation channel 11 in the implantation sleeve 1, determine that the implantation needle kit 12 to be used is inserted from the designated implantation outlet 112, and use the preset implantation channel 11 to ensure uniform needle insertion intervals;

[0064] Among them, the patient's paracervical tumor range is generally in the range of 2-5cm. If the patient's paracervical infiltration range is assessed to be 2cm in depth and the cervical length is 3cm, then the insertion sleeve 1 with a length of 3cm and a needle track interval of 1cm can be selected;

[0065] Step 3: First, the implantation sleeve 1 and the uterine cavity tube 2 are combined and fixed to ensure that the effective length of the uterine cavity tube 2 after being implanted into the uterine cavity is consistent with the detection length of step 1; according to the pre-treatment diagnostic image and the gynecological examination results of step 1, the effective depth of the implantation sleeve 1 to be implanted is clarified, and the fixing ring 3 needs to be installed at this position, on the one hand, to fix the relative position of the uterine cavity tube 2 and the implantation sleeve 1, and on the other hand, to limit the movement of the implantation sleeve 1 to prevent the implantation sleeve 1 and the uterine cavity tube 2 from being implanted too deep;

[0066] Among them, the inner diameter of the fixing ring 3 is 3 cm and the outer diameter is 4 cm;

[0067] After the uterine cavity tube 2 is inserted, an application tube / ring of a suitable size may also be implanted;

[0068] Step 4: With the patient in the lithotomy position and vaginal dilation, implant the source device assembled in step 3 into the patient's body, and fix the entire source device to the patient's transfer bed externally;

[0069] Step 5: Using a transfer bed, transfer the patient who has been implanted with the source device to the CT room or MR room for radiography to acquire images; based on the patient images after the source device is implanted, assess the required implantation depth of the implant needle kit 12 at each angle and keep a record;

[0070] Among them, the source application device designed in the utility model changes the need for doctors to conduct multiple CT scans to evaluate the implantation effect, and saves the operating steps of manually adjusting the position and angle of the implant sleeve 1 and the implant needle kit 12 repeatedly. Therefore, the utility model has a convenient and accurate adjustment method, which is practical and creative.

[0071] Step 6: According to the angle and depth data of the implant needle kit 12 recorded in step 5, use the scale at the tail end of the implant needle kit 12 to adjust the implant depth of the implant needle kit 12 to be used in the implant sleeve 1, and fix the tail end of the implant needle kit 12;

[0072] Among them, each wire of the implant needle kit 12 has a length scale mark to provide a scale reference for the doctor to implant;

[0073] If the judgment is made under medical imaging, the clock is used as a reference system. For example, if the tumor is located at the 3 o'clock direction and the depth is 3 cm, or at the 9 o'clock direction and the depth is 2 cm, the doctor will implant the implant needle guide wires at the 3 o'clock and 9 o'clock directions 3 cm and 2 cm inward at the tail of the implant sleeve 1 according to the implant guide wire scale display, and fix them at the tail.

[0074] Step 7: After the implantation of the implant needle kit 12 is completed, the patient's close-range treatment images are rescanned, and a treatment plan is formulated according to the conventional treatment process;

[0075] Step 8: Push the patient into the close-range treatment room. According to the arrangement order of the source channels in the treatment plan, use the conduction tube to connect the tails of different implant needle kits 12 to the treatment machine in sequence. Then, the staff in the control room uses the computer control program to execute the treatment plan formulated in step 7.

[0076] Among them, the radiation source welded to the end of the guide wire in step eight will be driven by a motor and transported in sequence from the shielded source reservoir of the treatment machine to the inside of different implant needle kits 12, and stay at the designated position in the channel of the implant needle kit 12 for a planned time, ultimately achieving local high-dose treatment of the tumor while greatly reducing damage to surrounding normal tissues.

[0077] In a preferred embodiment, as shown in the attached Figure 1-5 As shown, in step 2, one implantation inlet 111 corresponds to one implantation outlet 112, and one implantation inlet 111 and one corresponding implantation outlet 112 use the same channel mark; the information of the channel mark is represented by letters;

[0078] Among them, when the volume of letters and numbers is the same, if there are more than 9 implantation channels 11, the volume occupied by letters is obviously smaller than that of numbers.

[0079] In order to facilitate the selection of a suitable implantation needle kit 12 for close-range treatment, the length, diameter, position interval and number of the implantation channels 11 are described through channel markings in the instructions for use of the source application device of the utility model.

[0080] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0081] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A brachytherapy source device that is easy to implant, characterized in that: The source application device comprises: an implantation sleeve (1) implanted in the upper part of the cervical os, a uterine cavity tube (2) inserted into the middle of the implantation sleeve (1) for entering the uterine cavity, and a fixing ring (3) adjustable and fixedly sleeved in the middle of the implantation sleeve (1); The implantation sleeve (1) is provided with a plurality of implantation channels (11) inside, and an implantation needle kit (12) is placed inside the implantation channel (11); Both ends of the implantation channel (11) are respectively provided with an implantation inlet (111) and an implantation outlet (112); a plurality of the implantation inlets (111) are located on the end surface of the implantation sleeve (1), and a plurality of the implantation outlets (112) are located on the side surface of the implantation sleeve (1); The shape of the implantation channel (11) is set to be a spiral shape.

2. A brachytherapy source device that is easy to implant according to claim 1, characterized in that: Both ends of the implantation channel (11) are provided with channel markings.

3. A brachytherapy source device that is easy to implant according to claim 2, characterized in that: The diameter of the implantation channel (11) is greater than the diameter of the implantation needle kit (12).

4. The implantable brachytherapy source device according to claim 1, characterized in that: A plurality of the implantation inlets (111) are evenly distributed on the end surface of the implantation sleeve (1), and a plurality of the implantation outlets (112) are evenly distributed on the side surface of the implantation sleeve (1).

5. The brachytherapy source device for easy implantation according to claim 1, characterized in that: The distance between the plurality of implantation channels (11) is set at 0.5-1.5 cm.