CN113069680B - Applicator brachytherapy device with balloon fixation device and method of use - Google Patents
Applicator brachytherapy device with balloon fixation device and method of use Download PDFInfo
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- CN113069680B CN113069680B CN202110284492.1A CN202110284492A CN113069680B CN 113069680 B CN113069680 B CN 113069680B CN 202110284492 A CN202110284492 A CN 202110284492A CN 113069680 B CN113069680 B CN 113069680B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1014—Intracavitary radiation therapy
- A61N5/1016—Gynaecological radiation therapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1007—Arrangements or means for the introduction of sources into the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N2005/1092—Details
- A61N2005/1097—Means for immobilizing the patient
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Abstract
The applicator short-distance treatment tool comprises an inserting and planting template, an object holding rod, a uterine cavity tube and an air bag, wherein the air bag is an integral air bag arranged on the peripheral edge of the inserting and planting template, air needles are arranged on two sides of the top end of the object holding rod, which are in contact with the inserting and planting template, a control knob and an inflating bag are arranged at the tail part of the object holding rod, the control knob is used for controlling the opening or closing of the air needles, the air needles are inserted into the air bag after being opened, and the inflating bag is used for inflating or deflating the air bag through the object holding rod and the air bag. The invention can obviously improve the fixing performance of the applicator, reduce the displacement of the applicator, expand the air bag after being inflated, surround and cling to the vaginal wall, push the normal tissues and organs such as rectum, bladder and the like away by the air bag, reduce the irradiation dose of the air bag, and reduce the cost of the applicator and the treatment cost.
Description
Technical Field
The invention relates to the technical field of cervical cancer treatment appliances, in particular to a source applicator brachytherapy appliance with an air bag fixing device for cervical cancer and a using method thereof.
Background
Because the local tumor shapes of the cervix uteri of the cervical cancer patient are mostly not completely symmetrical geometric shapes, especially for eccentric tumors or patients accompanied with obvious invasion beside one side of the uterus, the traditional applicator with a single uterine tube cannot achieve good dose distribution, and a dose curve cannot completely wrap irregular tumor ranges, so that the dose curve can better wrap focuses and reduce normal tissue receiving amount, and the brachytherapy of intra-cavity combined inter-tissue interpolation is needed. The most representative applicator for intra-cavity united tissue interpolation in the world is the udler applicator.
The Udele tributary applicator has the following problems in the current clinical use process in China:
(1) the two dome balls of the udler tube applicator are very easy to displace, often do not fix well on a horizontal line after being placed on the vaginal vault, and the insertion needle on the dome ball is also displaced accordingly, so that dose curve optimization cannot be performed well when a physicist makes a brachytherapy plan.
(2) The Udele applicator is relatively single and fixed in size, and cannot realize the individual treatment. And most patients have poor vagina elasticity after external irradiation, and the applicator cannot be placed in the vagina. In addition, when the udler limb applicator is placed, the operation under general anesthesia cannot be realized due to the limitation of medical conditions, and the patient adaptability is poor; in addition, the vaginal extensibility and the vaginal width of Chinese women are smaller than those of European and American women, so that the applicator is very difficult to place, and only a few people can place the applicator smoothly.
(3) The imported Wudele applicator is very expensive, and the inserting needle is also very expensive as a consumable material, which is not beneficial to popularization.
(4) The applicator cannot be fixed well after being placed. In addition to the udler support applicator, most other applicators commonly used in hospitals, such as a single uterine tube applicator, a flat three-way applicator, and the fixation of the applicator after placement, have been a difficult problem. The physician will typically use an intravaginal yarn tamponade to secure the applicator and act to push the bladder rectum open. However, this method often results in uneven filling of the yarns in the vagina and sometimes does not function well in pushing away the bladder and rectum, and the patients are painful and have poor tolerance.
Disclosure of Invention
The technical purpose is as follows: aiming at the technical problems, the invention discloses a 3D printing implantation applicator brachytherapy appliance with an air bag fixing device and a using method thereof, the air bag fixing device is arranged, the fixing performance of the applicator can be obviously improved, the displacement of the applicator is reduced, meanwhile, an implantation template is individually designed, the size of the template can be designed according to the vaginal elasticity and the treatment needs of a patient, the operability and the patient tolerance are greatly improved, compared with the traditional mode of filling yarn strips in the vagina, the fixation is more uniform, the adjustment can be properly carried out according to the needs, and the pain of the patient is obviously reduced.
The technical scheme is as follows: in order to achieve the technical purpose, the invention adopts the following technical scheme:
a source applicator brachytherapy apparatus with an air bag fixing device is used for afterloading radiotherapy in a uterine cavity, and is characterized in that: the uterine cavity tube fixing device comprises an inserting and planting template, an object holding rod, a uterine cavity tube and an air bag, wherein a first channel is arranged at the top end of the inserting and planting template and used for fixing the uterine cavity tube, and a second channel is arranged at the bottom end of the inserting and planting template and used for fixing the top end of the object holding rod; the object holding rod is of a hollow pipeline structure and is used for conveying the inserting template to an affected part; the surface of the transplanting template is provided with a plurality of through holes used as transplanting needle channels;
the air bag is an integral air bag arranged at the peripheral edge of the inserting and planting template, air needles are arranged at two sides of the top end of the object holding rod, which are in contact with the inserting and planting template, one end of each air needle is communicated with the inside of the object holding rod, and the other end of each air needle is a needle tip; the tail part of the object holding rod is provided with a control knob and an inflation bag, the control knob is used for controlling the air needle to open or close, the air needle is inserted into the air bag after being opened, and the inflation bag is used for inflating or deflating the air bag through the object holding rod and the air needle.
Preferably, the peripheral edge of the inserting template is provided with a groove, and the air bag is fixed in the groove through viscose; the inflated air bag is inflated and then expanded to form an inflated structure surrounding the inserting and planting template.
Preferably, the control knob is connected with the tail part of the air needle through a spring, when the air needle is not inflated, the whole air needle is parallel to the object holding rod and is attached to the side wall of the object holding rod, when the air needle needs to be inflated, the spring control button on the object holding rod is unscrewed, the air needle is vertically opened towards two sides, and the tip of the opened air needle is over against the air hole of the air bag and extends into the air hole to inflate the air bag.
Preferably, the air bag is made of thin rubber materials.
Preferably, the implanting template is manufactured by adopting a 3D printing technology according to the specific tumor shape of the patient, and the shape of the implanting template is determined by the specific tumor shape.
Preferably, the first channel is an open-sided hollow structure extending a preset length into the interior of the template for insertion, and the second channel is an open-sided porous structure extending into the interior of the template for insertion.
Preferably, the number of the first channels is two, and the first channels are symmetrically arranged on two sides of one end, opposite to the second channel, of the transplanting template.
A method of using an applicator brachytherapy applicator having a balloon attachment device, comprising the steps of:
(1) the shape of the insertion template and the insertion needle path are designed in advance according to the elasticity of the vagina of a patient, the size and the shape of a tumor and the degree of parauterine invasion;
(2) the vaginal speculum is used for placing the applicator brachytherapy device on a tumor part of a patient for irradiation, namely after a uterine cavity tube, an inserting and planting template and an inserting and planting needle are sequentially placed, the vaginal speculum is taken out, a doctor continuously inflates or deflates the tail part of the object holding rod according to needs, air bags arranged on the peripheral edge of the inserting and planting template can be slowly opened after inflation, and the opening state of the air bags on the vaginal wall and the fixing state of the inserting and planting plate are adjusted;
(3) after the treatment is finished, the tail part of the object holding rod is deflated, the air in the air bag is released, and the applicator brachytherapy device is taken out.
Has the advantages that: due to the technical characteristics, the invention has the following technical effects:
(1) the invention adopts an individual design to insert the template, the size of the template can be designed according to the vagina elasticity and treatment requirements of the patient, and the operability and the tolerance of the patient are greatly improved.
(2) The invention can obviously improve the fixing performance of the applicator and reduce the displacement of the applicator by arranging the air bag fixing device. Compared with the yarn strip filling and fixing in the vagina, the air bag fixing device is more uniform in filling and fixing, can be properly adjusted according to needs, and obviously reduces the pain of a patient.
(3) The fixed air bag of the invention has 2 functions: immobilization: fixing the uterine cavity tube and the inserting template to the head side of the patient; the air bag is inflated to fill the vagina and the periphery of the air bag is encircled and tightly attached to the vaginal wall, so that the functions of further fixing the inserting and planting template, the inserting and planting needle and the uterine cavity tube can be achieved; 2. the functions of protecting normal tissues and organs are as follows: the air bag pushes away normal tissues and organs such as rectum and bladder, and reduces the irradiation dose to the tissues and organs.
(4) The applicators imported from abroad are expensive, some consumables can not be reused, and the burden of patients and countries is greatly increased. The invention can greatly reduce the cost of the applicator and the treatment cost and lighten the burden of patients and countries by improving and self-making the applicator.
Drawings
FIG. 1 is a schematic diagram of a first embodiment of an applicator brachytherapy device of the present invention with a balloon attachment mechanism;
FIG. 2 is a schematic view of the balloon of FIG. 1 after deployment;
FIG. 3 is a schematic view of the structure of the holding rod;
FIG. 4 is a cross-sectional view of the connection of the holding rod, the insertion template and the air bag in an uninflated state;
FIG. 5 is a cross-sectional view of the connection of the object holding rod, the insertion template and the air bag in an inflated state;
FIG. 6 is a schematic diagram of a regular shape of the template, wherein (a) is a symmetrical structure, (b) is a right structure, and (c) is a left structure;
1-inserting and planting template, 2-holding rod, 3-uterine cavity tube, 4-air bag, 5-first channel, 6-second channel, 7-inserting and planting needle channel, 8-air needle, 9-control knob, 10-air bag, 11-groove, 100-vaginal side wall, 40-air bag bottom, 101-air bag switch valve and 102-spring;
200-original plastic flat mold part, 201-added implant mold plate part.
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings.
Example one
As shown in fig. 1 and 2, the applicator brachytherapy device with the air bag fixing device comprises an insertion template 1, an object holding rod 2, a uterine cavity tube 3 and an air bag 4, wherein a first channel 5 at the top end of the insertion template 1 is used for fixing the uterine cavity tube 3, a second channel 6 is arranged at the bottom end of the insertion template 1 and is used for fixing the object holding rod 2, the object holding rod 2 is of a hollow pipeline structure, a plurality of through holes used as insertion needle channels 7 are arranged on the surface of the insertion template 1, and the air bag 4 is expanded after being inflated to form an inflation structure surrounding the insertion template. Wherein, first passageway 5 is outside opening, to inserting the interior hollow out construction that extends preset length of template 1, and second passageway 6 is outside opening, to inserting the poroid structure that the template 1 is inside to be planted, and the quantity of first passageway 5 is two, and the symmetry sets up in inserting the both sides of planting template 1 and the opposite one end of second passageway 6.
The peripheral edge of the inserting template 1 is provided with a groove 11, the air bag 4 is an integral air bag arranged on the peripheral edge of the inserting template 1, as shown in fig. 3, the air bag is arranged on the peripheral edge part of the inserting template, namely, a hollow groove 11 can be arranged on the edge of the template, and the air bag 4 is arranged in the groove 11 in advance. The air bag can be made of thin medical-grade rubber materials which are not easy to break. In the uninflated state, the air bag is arranged in a shrinking state in a groove at the edge of the transplanting template, and the groove and the air bag bottom 40 can be fixed by using a special adhesive.
As shown in fig. 4, the insertion template 1 is placed on the L-shaped structure holding rod on the surface of the tumor, and is a hollow pipeline. When the top end of the object holding rod is fixed on the inserting and planting template 1, two sides of the top end of the object holding rod, which are contacted with the inserting and planting template, are respectively provided with a small air needle 8, the tail part of the object holding rod is provided with a control knob device, the small air needles are unfolded and inserted into air bag small holes on two sides of the template, then the tail part of the object holding rod is provided with an air inflation bag similar to a mercury sphygmomanometer, a switch valve is arranged on the air inflation bag, the air inflation and air deflation can be carried out on the air inflation bag, and the size of the air inflation bag can be adjusted according to requirements. When the air bag reaches a satisfactory inflation state, a switch valve on the air bag is screwed to keep the air bag in an inflated state.
As shown in figure 3, the two sides of the top end of the object holding rod 2, which are contacted with the inserting and planting template 1, are provided with air needles 8, one end of each air needle 8 is communicated with the inside of the object holding rod, and the other end is a needle tip. The tail part of the object holding rod 2 is provided with a control knob 9 and an inflating bag 10, the control knob 9 is used for controlling the air needle 8 to open or close, the air needle 8 is inserted into the air bag 4 after opening, and the inflating bag 10 is used for inflating or deflating the air bag 4 through the object holding rod 2 and the air needle 8. In this embodiment, the control of the air pin 8 is connected to the tail of the air pin by a spring 102. Fig. 3 and 4 are the non-inflated state, and the whole air needle is parallel to the object holding rod and clings to the inner wall of the object holding rod. When inflation is required, the spring control button 9 on the holding rod is unscrewed, the air needle 8 is vertically opened towards two sides and extends into the air hole of the air bag 4 for inflation, and the inflated state is shown in fig. 5.
In this embodiment, the shape of the insertion template 1 is irregular. However, for irregular tumors or when the existing template can not meet the treatment requirement, the number and the positions of the inserting needles can be designed according to the shape of the cervical tumor of the patient, and the inserting template applicator is printed in an individualized 3D mode. According to the elasticity of the vagina of a patient, the size and the shape of a tumor and the degree of parauterine invasion, the shape of an insertion template and an insertion needle channel are designed in advance, and the device is particularly suitable for the conditions of irregular shape, eccentric tumor, parauterine invasion and the like; through the 3D printing technology, the individualized inserting and implanting template is prepared, a near-distance radiotherapy plan can be better optimized and formulated, the local control rate of tumors is improved, and the damage to normal tissues and organs is reduced.
Example two
For the comparison of tumor shapes, some commonly used implantation templates are usually prepared for clinical selection: for example, the insertion template with the diameter of 2 cm or 3cm is symmetrically distributed on two sides of the insertion needle channel, or is deviated from the left side or the right side, and a plurality of combined templates are designed approximately. As shown in FIGS. 6 (a) - (c).
The steps of inserting the template and 3D printing and manufacturing are as follows:
(1) firstly, the needle distribution template required by the brachytherapy is designed according to gynecological examination and imaging examination (C T/MRI and the like). This template is generally matched to the general shape of the patient's cervical tumor and the location and number of insertion needle holes required is designed according to the plan.
(2) The fixed position of the uterine cavity tube is arranged at a certain position of the template, the position is not necessarily positioned at the center, the fixed channel of the uterine cavity tube can be arranged at a certain position of the template according to the requirement of the needle arrangement of the inserting needle, for example, the tumor is deviated to the right side, the inserting needle is basically arranged at the right side, the fixed channel of the uterine cavity tube can be arranged at the deviated left part of the inserting template, the other end of the template is provided with a pore channel, a rod of a holding object is fixed at the position, and the template can be delivered to the surface of the cervical tumor.
When the applicator brachytherapy device is used, the air bags are arranged at the edges of the periphery of the pre-designed and manufactured inserting template, and the tail of the object holding rod for placing the inserting template is provided with the trigger switch. After the vagina speculum is opened, the vagina is disinfected, the uterine cavity tube, the inserting template and the inserting needle are sequentially placed, the vagina speculum is taken out after the uterine cavity tube, the inserting template and the inserting needle are sequentially placed, the air bag switch is started, and the air bags arranged on the peripheral edges of the inserting template in advance can be slowly popped out and unfolded. Then along with the entering of the air, the air bag is slowly expanded to fill the vagina along the vaginal wall, so as to achieve the functions of fixing the inserting and planting template and inserting and planting needle. The placement of the inserting and planting needles is to insert the needles according to the distribution of needle channels on the pre-designed inserting and planting template. The air bag not only plays a role of inserting a needle uterine cavity tube into a fixed template, but also can uniformly open mucosa around the vaginal wall, is similar to a clinical vaginal model, can push normal tissues and organs such as rectum and bladder away, can push tissues such as bladder and rectum away, and can adaptively adjust the inflation degree of the air bag to adjust the pushing distance according to treatment needs. Meanwhile, the doctor can continuously inflate or deflate the tail part of the object holding rod according to the requirement, and the expansion of the air bag to the vaginal wall and the fixation of the inserting plate are adjusted to the optimal state.
The above description is only of the preferred embodiments of the present invention, and it should be noted that: it will be apparent to those skilled in the art that various modifications and adaptations can be made without departing from the principles of the invention and these are intended to be within the scope of the invention.
Claims (4)
1. A source applicator brachytherapy apparatus with an air bag fixing device is used for afterloading radiotherapy in a uterine cavity, and is characterized in that: the device comprises an inserting template (1), an object holding rod (2), a uterine cavity tube (3) and an air bag (4), wherein a first channel (5) is formed in the top end of the inserting template (1) and used for fixing the uterine cavity tube (3), and a second channel (6) is formed in the bottom end of the inserting template (1) and used for fixing the top end of the object holding rod (2); the object holding rod (2) is of a hollow pipeline structure and is used for conveying the inserting template (1) to an affected part; the surface of the transplanting template (1) is provided with a plurality of through holes used as transplanting needle channels (7);
the air bag (4) is an integral air bag arranged on the peripheral edge of the inserting and planting template (1), air needles (8) are arranged on two sides of the top end of the object holding rod (2) which are in contact with the inserting and planting template (1), one end of each air needle (8) is communicated with the inside of the object holding rod, and the other end of each air needle is a needle tip; the tail part of the object holding rod (2) is provided with a control knob (9) and an inflating bag (10), the control knob (9) is used for controlling the opening or closing of the air needle (8), the air needle (8) is inserted into the air bag (4) after being opened, and the inflating bag (10) is used for inflating or deflating the air bag (4) through the object holding rod (2) and the air needle (8);
the peripheral edge of the transplanting template (1) is provided with a groove (11), and the air bag (4) is fixed in the groove (11) through viscose; the air bag (4) is expanded after being inflated to form an inflation structure surrounding the inserting and planting template;
the control knob (9) is connected with the tail part of the air needle (8) through a spring (102), when the air needle is not inflated, the whole air needle (8) is parallel to the object holding rod (2) and is attached to the side wall of the object holding rod (2), when the air needle needs to be inflated, the spring control knob (9) on the object holding rod is unscrewed, the air needle (8) is vertically opened towards two sides, and the tip of the opened air needle (8) is over against the air hole of the air bag (4) and extends into the air hole to inflate the air bag;
the inserting template (1) is manufactured by adopting a 3D printing technology according to the specific tumor shape of a patient, and the shape of the inserting template (1) is determined by the specific tumor shape.
2. The applicator brachytherapy applicator with balloon attachment means of claim 1, wherein: the air bag (4) is made of thin rubber materials.
3. The applicator brachytherapy applicator with balloon attachment means of claim 1, wherein: the first channel (5) is a hollow structure with an opening at the outer side and a preset length extending towards the inside of the inserting template (1), and the second channel (6) is a hole-shaped structure with an opening at the outer side and extending into the inside of the inserting template (1).
4. The applicator brachytherapy applicator with balloon attachment means of claim 1, wherein: the number of the first channels (5) is two, and the two first channels are symmetrically arranged on two sides of one end, opposite to the second channel (6), of the planting template (1).
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| CN202110284492.1A CN113069680B (en) | 2021-03-17 | 2021-03-17 | Applicator brachytherapy device with balloon fixation device and method of use |
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| CN202110284492.1A CN113069680B (en) | 2021-03-17 | 2021-03-17 | Applicator brachytherapy device with balloon fixation device and method of use |
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| CN113069680B true CN113069680B (en) | 2021-10-26 |
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