Vaginal source device

Abstract

The present invention relates to the technical field of medical devices, and discloses a vaginal source applicator, including a slidably connected source applicator and a fixing device, the fixing device is also provided with a locking member for limiting the movement of the source applicator, the source applicator includes a connected source part and an adjustment part, the adjustment part is provided with a scale, and the source part and the adjustment part are provided with a catheter channel that penetrates the source part and the adjustment part for the catheter connected to the source applicator and the radiotherapy machine to pass through; the fixing device includes a fixing plate and a fixing belt, the fixing plate fits the perineum of the patient, the fixing plate is provided with a plurality of fixing grooves, the fixing belt includes a first fixing part and a second fixing part, the first fixing part and the second fixing part are enclosed to form a fixing belt, the fixing belt is looped around the patient's waist, a plurality of fixing drawstrings are connected below the fixing belt, and the fixing drawstrings correspond to the fixing grooves one by one. The vaginal source applicator using the technical solution of the present invention has a simple structure, is easy to use, has a low cost, is accurately positioned, and is easy to position and fix.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a vaginal source applicator. Background Art

[0002] One of the common methods for the treatment of cervical cancer, endometrial cancer, vaginal cancer and perineal cancer is brachytherapy (also known as "short distance therapy") high dose rate radiotherapy. Brachytherapy is a radiotherapy in which the radioactive source is placed inside or adjacent to the target tissue (malignant tumor). During the radiotherapy of cancer patients, the radioactive source is sent into the vagina by an afterloader (brachytherapy machine) through a catheter to reach the cervix and after a predetermined dwell time, it returns to the afterloader. The main challenge when using a cylindrical applicator is the accuracy of the radiation dose received by the target site, which is determined by the relative position of the applicator (source) and the treatment area to the surrounding healthy tissues and organs. In order to accurately obtain the relative position of the applicator and the treatment area, computed tomography (CT) imaging or magnetic resonance imaging (MRI) can be used to generate a 3D model of the applicator and the treatment area. Even a relatively small geometric uncertainty (required to be within 1mm) of a vaginal cylindrical applicator in the treatment area may have a critical impact on the radiation dose delivered to the target tissue and normal organs.

[0003] Misplacement of the applicator may result in insufficient dose to the target tissue (resulting in the recurrence of cancerous tissue) and excessive radiation dose to nearby healthy tissue (resulting in unwanted damage to healthy tissue). However, due to the time interval between the CT (or MRI) scan and the actual radiation therapy (sometimes up to 1-2 hours), especially due to patient movement (such as sneezing) during the treatment, the applicator position may change during this period, directly affecting the treatment results.

[0004] The vaginal cylindrical applicators currently used in the treatment of cervical cancer are composed of many parts and have a complex structure. Sometimes it takes extra time to assemble the applicators before treatment. What's worse, all the cylindrical applicators must be disassembled and cleaned after each use, and they must be sterilized again before use, which greatly reduces the efficiency of post-installation. And repeated disassembly and installation often cause some parts to be lost. Summary of the invention

[0005] The purpose of the present invention is to provide a vaginal source applicator, which has a simple structure, is easy to use, has a low cost, is accurately positioned, and is easy to position and fix.

[0006] In order to achieve the above-mentioned purpose, the present invention provides a vaginal source applicator, comprising a source applicator and a fixing device for fixing the source applicator to the perineum of a patient, the source applicator being slidably connected to the fixing device, the fixing device being further provided with a locking member for limiting the movement of the source applicator, the locking member limiting the movement of the source applicator by point limiting or local limiting; the source applicator comprising a connected source applicator portion and an adjusting portion, the adjusting portion being provided with a scale for locating the insertion depth of the source applicator into the patient's vagina, the source applicator portion and the adjusting portion being provided with at least one catheter channel penetrating the source applicator portion and the adjusting portion for allowing a catheter connected to a radiotherapy machine to pass through; the fixing device comprising a fixing plate and a fixing belt, the fixing plate being fitted with the perineum of the patient, the fixing plate being provided with a plurality of fixing grooves, the fixing belt comprising a first fixing portion and a second fixing portion, the first fixing portion and the second fixing portion being enclosed to form a fixing belt, the fixing belt being arranged around the patient's waist, a plurality of fixing drawstrings being connected below the fixing belt, the fixing drawstrings corresponding one to one to the fixing grooves.

[0007] Preferably, an introduction portion is provided at a top end of the application source portion away from the regulating portion, and the introduction portion has an arc shape.

[0008] Preferably, the outer diameter of the regulating portion is smaller than the outer diameter of the application source portion, and a positioning step is formed at the connection between the regulating portion and the application source portion.

[0009] Preferably, the diameter of the application portion ranges from 20 to 40 mm, and the diameter of the adjustment portion ranges from 10 to 20 mm.

[0010] Preferably, the source portion is provided with an air intake pipe connecting the duct channel with the outside of the source portion, one end of the air intake pipe is connected to the duct channel, and the other end of the air intake pipe is connected to the outer wall of the introduction portion; the adjustment portion is provided with a plurality of ventilation pipes connecting the duct channel with the outside of the adjustment portion, one end of the ventilation pipe is connected to the duct channel, and the other end of the ventilation pipe is connected to the outer wall of the adjustment portion.

[0011] Preferably, the fixing device also includes a connecting buckle, and the fixing drawstring includes a first fixing drawstring, a second fixing drawstring and a third fixing drawstring, the first fixing drawstring bypasses the connecting buckle and is connected to the first fixing part, the second fixing drawstring bypasses the connecting buckle and is connected to the second fixing part, the third fixing drawstring is connected to the fixed waist belt, and the third fixing drawstring is arranged opposite to the connecting buckle.

[0012] Preferably, the source portion and the regulating portion are integrally formed.

[0013] Preferably, the fixing grooves include a first connecting groove and a second connecting groove which are interconnected, the first connecting groove is arranged along the width direction of the fixing plate, the second connecting groove is arranged along the length direction of the fixing plate, the first connecting groove and the second connecting groove form an L-shaped fixing groove, and the groove width of the second connecting groove is smaller than the groove width of the first connecting groove.

[0014] Preferably, the first fixing strap is integrally formed with the first fixing portion, and the second fixing strap is integrally formed with the second fixing portion.

[0015] Preferably, a metal ball is provided at the top of the introduction portion away from the adjustment portion.

[0016] Compared with the prior art, the vaginal source applicator of the embodiment of the present invention has the following beneficial effects:

[0017] The vaginal source applicator of the embodiment of the present invention only needs to insert the source part into the patient's vagina when in use. The depth of the source part inserted into the patient's vagina can be adjusted by adjusting the adjustment part. A plurality of catheter channels are provided inside the source applicator for the catheter connected to the radiotherapy machine to pass through. The catheter can be installed in the catheter channel, and a steel wire with a radiation source is sent into the catheter to transport the radiation source for radiotherapy. In this embodiment, the source applicator is fixed to the patient's perineum by a fixing device, a fixing plate is attached to the patient's perineum and fixes the position of the source applicator, a fixing belt loop is arranged on the patient's waist, the fixing belt is connected to the fixing drawstring, and the fixing drawstring is fixedly connected in the fixing groove, so that the fixing plate is limited to the patient's perineum, thereby limiting the relative movement of the source applicator and the patient, and the relative position relationship between the fixing drawstring of the fixing device and the fixing groove can be adjusted so that the vaginal source applicator in this embodiment can adapt to the body shape of different users, thereby making the positioning of the source applicator more accurate. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 Schematic diagram of the assembly structure of the source applicator and the fixing plate in an embodiment of the present invention;

[0019] Figure 2 is a schematic diagram of the structure of a fixed waist belt and a fixed drawstring in an embodiment of the present invention;

[0020] Figure 3 is a schematic structural diagram of a fixing plate in an embodiment of the present invention;

[0021] Figure 4 is a top view of the assembly structure of the source applicator and the fixing plate in an embodiment of the present invention;

[0022] Figure 5 yes Figure 4 The cross-sectional view at A-A in the middle;

[0023] Figure 6 yes Figure 4 The cross-sectional view at B-B in the middle;

[0024] In the figure, 1. source applicator, 11. source application part, 11a, marker, 12. adjustment part, 13. catheter, 14. steel wire, 15. ventilation duct, 16. air intake duct, 2. fixing plate, 21. first fixing groove, 22. second fixing groove, 23. third fixing groove, 24. fastening screw, 25. connecting through hole, 3. fixing belt, 31. first fixing part, 32. second fixing part, 33. connecting buckle, 34. first fixing pull strap, 35. second fixing pull strap, 36. third fixing pull strap. DETAILED DESCRIPTION

[0025] The specific embodiments of the present invention are further described in detail below in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of the present invention.

[0026] It should be understood that the present invention uses the terms "first", "second", etc. to describe various information, but these information should not be limited to these terms, and these terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of the present invention, "first" information may also be referred to as "second" information, and similarly, "second" information may also be referred to as "first" information.

[0027] like Figures 1 to 6As shown, a vaginal source applicator device according to a preferred embodiment of the present invention comprises a source applicator 1 and a fixing device for fixing the source applicator 1 to the perineum of a patient, the source applicator 1 is slidably connected to the fixing device, the fixing device is also provided with a locking member for limiting the movement of the source applicator 1, the locking member limits the movement of the source applicator 1 by point limiting or local limiting; the source applicator 1 comprises a connected source portion 11 and an adjusting portion 12, the source portion 11 is connected to the adjusting portion 12, the adjusting portion 12 of the source applicator 1 is provided with a scale for locating the insertion depth of the source applicator 1 into the patient's vagina, thereby ensuring the repeatability of positioning during multiple treatments and ensuring the consistency of multiple installation positions. At least one catheter channel is provided in the source part 11 and the adjustment part 12, which runs through the source part 11 and the adjustment part 12 for the catheter 13 connected to the radiotherapy machine to pass through; the fixing device includes a fixing plate 2 and a fixing belt 3, the fixing plate 2 is in contact with the perineum of the patient, and a plurality of fixing grooves are provided on the fixing plate 2, the fixing belt 3 includes a first fixing part 31 and a second fixing part 32, the first fixing part 31 and the second fixing part 32 are enclosed to form a fixing belt, the fixing belt is looped around the patient's waist, and a plurality of fixing drawstrings are connected below the fixing belt, and the fixing drawstrings correspond to the fixing grooves one by one.

[0028] Based on the above technical scheme, when in use, it is only necessary to insert the source part 11 into the patient's vagina. The depth of the source part 11 inserted into the patient's vagina can be adjusted by adjusting the adjustment part 12. A plurality of catheter channels are provided inside the source device 1 for the catheter 13 connected to the radiotherapy machine to pass through. The catheter 13 can be installed in the catheter channel, and a steel wire with a radioactive source is sent into the catheter 13, and the radioactive source is transported for radiotherapy. In this embodiment, the source device 1 is fixed to the perineum of the patient by a fixing device, the fixing plate 2 is attached to the perineum of the patient and fixes the position of the source device 1, the fixing belt loop is arranged on the patient's waist, the fixing belt is connected to the fixing drawstring, and the fixing drawstring is fixedly connected in the fixing groove, so that the fixing plate 2 is limited to the perineum of the patient, thereby limiting the relative movement of the source device 1 and the patient, and the relative position relationship between the fixing drawstring of the fixing device and the fixing groove can be adjusted so that the vaginal source device in this embodiment can adapt to the body shape of different users, thereby making the positioning of the source device 1 more accurate.

[0029] Furthermore, an introduction portion is provided at the top of the source portion 11 away from the adjusting portion 12, and the outer shape of the introduction portion is arc-shaped, thereby facilitating the insertion of the source applicator 1 into the patient's vagina to avoid damage to the vagina. The outer diameter of the adjusting portion 12 is smaller than the outer diameter of the source portion 11, and a positioning step is formed at the connection between the adjusting portion 12 and the source portion 11, thereby limiting the position of the source applicator 1. Furthermore, the cross-sectional size of the adjusting portion 12 is smaller than the cross-sectional size of the source portion 11, thereby further avoiding damage to the patient's vagina.

[0030] In this embodiment, the diameter of the applicator 11 ranges from 20 to 40 mm, and the diameter of the adjustment portion 12 ranges from 10 to 20 mm, thereby meeting the usage requirements of different patients. Applicators of different sizes can be selected according to the size of the patient's vagina.

[0031] Furthermore, the source portion 11 is provided with a plurality of air intake pipes 16 connecting the catheter channel with the outside of the source portion, one end of the air intake pipe 16 is connected to the catheter channel, and the other end of the air intake pipe 16 is connected to the outer wall of the introduction portion; the adjustment portion 12 is provided with a plurality of ventilation pipes 15 connecting the catheter channel with the outside of the adjustment portion, one end of the ventilation pipe 15 is connected to the catheter channel, and the other end of the ventilation pipe 15 is connected to the outer wall of the adjustment portion 12. In this way, the gas generated when the source device 1 is inserted into the vagina can be guided out of the source device 1, eliminating the air pocket between the source device 1 and the vaginal wall.

[0032] Preferably, the fixing device also includes a connecting buckle 33, and the fixing strap includes a first fixing strap 34, a second fixing strap 35 and a third fixing strap 36. The first fixing strap 34 bypasses the connecting buckle 33 and is connected to the first fixing part 31, the second fixing strap 35 bypasses the connecting buckle 33 and is connected to the second fixing part 32, the third fixing strap 36 is connected to the fixed waist belt, and the third fixing strap 36 is arranged opposite to the connecting buckle 33. In this embodiment, the number of fixing grooves on the fixing plate 2 is 3, which are marked as the first fixing groove 21, the second fixing groove 22, and the third fixing groove 23 respectively. The first fixing strap 34 is inserted into the first fixing groove 21, the second fixing strap 35 is inserted into the second fixing groove 22, and the third fixing strap 36 is inserted into the third fixing groove 23. The connecting buckle 33 facilitates the patient to adjust the positions of the first fixing strap 34 and the second fixing strap 35.

[0033] Preferably, the source portion 11 and the adjustment portion 12 are integrally formed, thereby facilitating the manufacture of the source applicator 1 and providing it with sufficient strength, thereby facilitating the insertion of the source applicator 1 into the patient's vagina.

[0034] In this embodiment, the fixing plate 2 is also provided with a connecting through hole 25 and a mounting portion, and the mounting portion is arranged on the side opposite to the fitting surface that fits the patient. In this embodiment, the fixing plate 2 is in an arc shape, so that it fits better with the perineum of the patient, and further ensures the reliability of the installation position of the source applicator 1. The connecting through hole 25 is arranged on the mounting portion of the fixing plate 2, and the mounting portion protrudes from the fixing plate 2, thereby ensuring the strength of the mounting portion after the hole is opened. The source applicator 1 is inserted into the connecting through hole 25. The fixing plate 2 is also provided with a locking member, and the locking member limits the movement of the source applicator 1 by point limiting or local limiting. In this embodiment, the locking member is a fastening screw 24, and a screw hole is provided on the fixing plate 2. The screw hole is arranged on the mounting portion and intersects with the connecting through hole 25. The angle between the axis of the source applicator 1 and the axis of the screw hole is 40-50°, thereby facilitating the use of adjusting the tightness of the fastening screw 24 to change the relative position of the source applicator 1. The adjusting portion 12 is shaped like a circular boss and is provided with two cross-sections, which are parallel to the axial direction of the adjusting portion 12. In the present embodiment, the two cross-sections are symmetrically arranged about the axis of the adjusting portion 12, and the connecting through hole 25 matches the outer shape of the adjusting portion 12, thereby preventing the applicator 1 from rotating and further ensuring that the applicator 1 is accurately positioned. Scale markings are provided on the cross-sections, thereby facilitating the adjustment of the depth of the applicator 1 inserted into the vagina and conveniently recording the depth of the applicator 1 inserted into the vagina.

[0035] Specifically, the fixing grooves on the fixing plate 2 include a first connecting groove and a second connecting groove that are interpenetrating with each other, the first connecting groove is arranged along the width direction of the fixing plate 2, the second connecting groove is arranged along the length direction of the fixing plate 2, the first connecting groove and the second connecting groove form an L-shaped fixing groove, the groove width of the second connecting groove is smaller than the groove width of the first connecting groove, and in this embodiment, the groove width of the second connecting groove is smaller than the diameter of the fixing drawstring. Therefore, when the fixing drawstring enters from the first connecting groove and slides into the second connecting groove, the fixing drawstring is clamped in the fixing groove, which facilitates fixing the source applicator 1 on the perineum of the patient.

[0036] Preferably, the first fixing strap 34 is integrally formed with the first fixing part 31, and the second fixing strap 35 is integrally formed with the second fixing part 32, thereby facilitating the production and manufacture of the fixing device. In this embodiment, the first fixing part 31 and the second fixing part 32 are integrally formed, and the fixing strap and the fixing belt are fixing ropes.

[0037] In this embodiment, the source applicator 1, the fixing plate 2 and the connecting buckle 33 are all made of non-toxic and tasteless hard plastic. Therefore, the vaginal source applicator device in this embodiment has low cost and can be discarded after a single use, avoiding the problem of incomplete cleaning affecting the use, and at the same time eliminating the possibility of component loss and cross infection during repeated use.

[0038] Furthermore, a metal ball is provided at the top of the introduction part away from the adjustment part 12. The metal ball is a positioning marker 11a for marking a suitable position for X-ray, CT and MRI scanning. The positioning marker 11a is made of a marking metal that can be used for X-ray, CT and MRI scanning, such as copper.

[0039] Preferably, a bell is provided at one end of the fixed drawstring away from the fixed waist belt, thereby facilitating the storage of the fixed drawstring and preventing the fixed drawstring from being directly separated from the fixed plate 2. In this embodiment, a connecting piece and a cable tie for fastening the fixed drawstring are also included, and a fixing groove corresponding to the fixed drawstring is provided on the connecting piece. Therefore, after production, the fixed drawstring can be fixed using the connecting piece and the cable tie, avoiding multiple fixed drawstrings and the fixed waist belt being entangled and inconvenient to use.

[0040] In this embodiment, a catheter 13 is installed in the catheter channel inside the applicator 1, and a steel wire 14 with a radiation source is provided in the catheter 13, thereby facilitating the connection of the applicator in this embodiment with the afterloader for radiotherapy.

[0041] In this embodiment, the size of the applicator portion 11 on the applicator can be customized to different specifications according to the usage needs of different patients, thereby increasing the comfort of the patient in using the applicator. Furthermore, the size of the applicator is closer to the size of the patient's vagina, thereby increasing the accuracy of installation and positioning of the applicator during radiotherapy.

[0042] The working process of the present invention is: insert the source part 11 into the patient's vagina, fit the fixing plate 2 to the patient's perineum, wear the fixing belt on the patient's waist, and adjust the adjustment part 12 to adjust the depth of the source part 11 inserted into the patient's vagina. Use the locking screw to lock the source device 1 and the fixing plate 2, and clamp the first fixing strap 34, the second fixing strap 35 and the third fixing strap 36 in the corresponding first fixing groove 21, the second fixing groove 22 and the third fixing groove 23 respectively. Connect the catheter 13 to the close-range radiotherapy machine, control the close-range radiotherapy machine to transport the radiation source for radiotherapy, and the source device can be removed and discarded after use.

[0043] In summary, an embodiment of the present invention provides a vaginal source applicator. When the vaginal source applicator is in use, it is only necessary to insert the source part 11 into the patient's vagina. The depth of the source part 11 inserted into the patient's vagina can be adjusted by adjusting the adjustment part 12. A plurality of catheter channels are provided inside the source applicator 1 for the catheter 13 connected to the radiotherapy machine to pass through. The catheter 13 can be installed in the catheter channel, and a steel wire with a radioactive source is sent into the catheter 13, and the radioactive source is transported for radiotherapy. In this embodiment, the source applicator 1 is fixed to the perineum of the patient by a fixing device, the fixing plate 2 is attached to the perineum of the patient and fixes the position of the source applicator 1, the fixing belt loop is arranged on the patient's waist, the fixing belt is connected to the fixing drawstring, and the fixing drawstring is fixedly connected in the fixing groove, so that the fixing plate 2 is limited to the perineum of the patient, thereby limiting the relative movement of the source applicator 1 and the patient, and the relative position relationship between the fixing drawstring of the fixing device and the fixing groove can be adjusted so that the vaginal source applicator in this embodiment can adapt to the body shape of different users, thereby making the positioning of the source applicator 1 more accurate.

[0044] In the description of the present invention, it is necessary to understand that the orientations or positional relationships indicated by terms such as “upper”, “lower”, “left”, “right”, “top” and “bottom” are based on the orientations or positional relationships shown in the accompanying drawings and are only for the convenience of describing the present invention and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0045] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and substitutions can be made without departing from the technical principles of the present invention. These improvements and substitutions should also be regarded as the scope of protection of the present invention.

Claims

1. A vaginal applicator, characterized in that: It comprises an applicator and a fixing device for fixing the applicator on the perineum of a patient, the applicator is slidably connected to the fixing device, the fixing device is also provided with a locking member for limiting the movement of the applicator, and the locking member limits the movement of the applicator by point limiting or local limiting; The source applicator comprises a source applicator and an adjustment part connected to each other, the adjustment part is provided with a scale for locating the insertion depth of the source applicator into the patient's vagina, and the source applicator and the adjustment part are provided with at least one catheter channel penetrating the source applicator and the adjustment part for a catheter connected to the radiotherapy machine to pass through; The fixing device includes a fixing plate and a fixing belt, the fixing plate is fitted with the perineum of the patient, a plurality of fixing grooves are arranged on the fixing plate, the fixing belt includes a first fixing part and a second fixing part, the first fixing part and the second fixing part are enclosed to form a fixing belt, the fixing belt is looped around the patient's waist, a plurality of fixing drawstrings are connected below the fixing belt, and the fixing drawstrings correspond one-to-one to the fixing grooves.

2. The vaginal applicator according to claim 1, characterized in that: The application source portion is provided with an introduction portion at a top end away from the adjustment portion, and the appearance of the introduction portion is an arc shape.

3. The vaginal applicator according to claim 1, characterized in that: The outer diameter of the adjusting portion is smaller than the outer diameter of the application source portion, and a positioning step is formed at the connection between the adjusting portion and the application source portion.

4. The vaginal applicator according to claim 3, characterized in that: The diameter of the application part ranges from 20 to 40 mm, and the diameter of the adjustment part ranges from 10 to 20 mm.

5. The vaginal applicator according to claim 2, characterized in that: The source portion is provided with an air intake pipe connecting the conduit channel and the outside of the source portion, one end of the air intake pipe is connected to the conduit channel, and the other end of the air intake pipe is connected to the outer wall of the introduction portion; The regulating part is provided with a plurality of ventilation pipes connecting the conduit channel and the outside of the regulating part, one end of the ventilation pipe is connected to the conduit channel, and the other end of the ventilation pipe is connected to the outer wall of the regulating part.

6. The vaginal applicator according to claim 1, characterized in that: The fixing device also includes a connecting buckle, and the fixing drawstring includes a first fixing drawstring, a second fixing drawstring and a third fixing drawstring, the first fixing drawstring bypasses the connecting buckle and is connected to the first fixing part, the second fixing drawstring bypasses the connecting buckle and is connected to the second fixing part, the third fixing drawstring is connected to the fixed waist belt, and the third fixing drawstring is arranged opposite to the connecting buckle.

7. The vaginal applicator according to claim 1, characterized in that: The source application portion and the adjustment portion are integrally formed.

8. The vaginal applicator according to any one of claims 1 to 7, characterized in that: The fixing grooves each include a first connecting groove and a second connecting groove that penetrate each other, the first connecting groove is arranged along the width direction of the fixing plate, and the second connecting groove is arranged along the length direction of the fixing plate, the first connecting groove and the second connecting groove form an L-shaped fixing groove, and the groove width of the second connecting groove is smaller than the groove width of the first connecting groove.

9. The vaginal applicator according to claim 6, characterized in that: The first fixing strap is integrally formed with the first fixing portion, and the second fixing strap is integrally formed with the second fixing portion.

10. The vaginal applicator according to claim 2, characterized in that: A metal ball is arranged at the top of the introduction part away from the regulating part.

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