CN106039551A - Catheter device and brachytherapy system - Google Patents

Abstract

The present invention provides a catheter device comprising: a tubular structure; a plurality of fluid flow tube structures each having a proximal direction and a distal direction and disposed along a first axial direction of the tubular structure; a plurality of node units arranged along the first axial direction of the tubular structure, wherein a section is formed between every two adjacent node units; and the outer layer element covers the plurality of node units, so that the interval formed between two adjacent node units forms a space. The catheter device can irradiate the whole diffuse tumor in one-time brachytherapy without repeatedly placing a catheter; meanwhile, the patient can be smoothly placed in the narrow cavity of the patient due to the absence of an external air bag. The invention also provides a brachytherapy system employing the catheter apparatus.

Description

Catheter device and brachytherapy system

technical field

The invention relates to a catheter device for brachytherapy, in particular to a brachytherapy catheter device with expandable and contractable elements and a brachytherapy system.

Background technique

Radiation therapy can be divided into two categories, namely external beam radiation therapy and brachytherapy (brachytherapy). Brachytherapy for tumors is to use catheters to enter body cavities or organs, place the catheters close to the tumor tissue, and then use post-loading therapy equipment. It is a technology to transport the radiation source into the catheter so that the radiation emitted by the radiation source can irradiate the tumor area at close range, and let the high-energy radiation transmitted in the form of light waves or high-speed particles destroy tumor cells and inhibit the growth of tumor cells. Brachytherapy is especially suitable for tumors growing in body cavities, such as esophageal cancer, cervical cancer, endometrial cancer, nasopharyngeal cancer, lung cancer, rectal cancer, and other tumors with lumens for catheter placement. In addition, brachytherapy can also be used for non-luminal tumors, such as prostate cancer, breast cancer, malignant sarcoma, brain tumor, etc., by means of tissue insertion.

When performing external beam radiation therapy or brachytherapy, the normal tissues around the tumor will be exposed to radiation and cause side effects. Taking the skin as an example, areas that are often rubbed, such as underarms and crotch, are prone to inflammation and broken skin after radiation exposure. Radiation therapy to the abdomen is often associated with diarrhea as a side effect. Radiation therapy to the head and neck may result in thickened saliva, decreased saliva, altered sense of taste, redness and swelling of the oral mucosa, dry mouth, difficulty swallowing, and even loss of appetite. Chest radiation therapy may produce radiation pneumonitis, esophageal inflammation, etc., and even acute bleeding of the esophagus. Therefore, the ideal situation of radiation therapy is to deliver a dose sufficient to kill tumor cells while sparing normal tissues.

The occurrence of side effects of radiation therapy is related to the site of radiation exposure and the dose of radiation. Taking brachytherapy as an example, the closer the normal tissue is to the radiation source, the higher the dose absorbed by the normal tissue and the greater the side effects. Because the intensity of the radioactive source will decrease inversely proportional to the square of the distance. Therefore, the optimal dose of brachytherapy is the dose that can kill tumor cells without causing damage to normal tissues. As shown in Figure 1 (Hitoshi Ikushima, Radiation therapy: state of the art and the future, The Journal of Medical Investigation Vol.57February 2010). At present, the way of improving dose conformity and homogeneity is mostly used to increase the dose of tumor treatment, and reduce the dose and range of radiation exposure to normal tissues (shifting the normal tissue toxicity curve to the right in Figure 1). , to increase cure rates and reduce normal tissue toxicity. Since each patient's body cavity/organ and tumor size are different, it is the biggest difficulty in clinical personalized medicine to provide the optimal treatment dose according to each patient's normal tissue, tumor and radiation source conditions. In addition, the organs in the body will have a natural internal movement with breathing. For example, when inhaling, the diaphragm descends and the chest cavity expands. All organs in the chest cavity will move due to breathing, resulting in inaccurate radiation therapy. Therefore, it is necessary to take into account the displacement deviation during treatment, as shown in Figure 2 (Hitoshi Ikushima, Radiation therapy: state of the art and the future, The Journal of Medical Investigation Vol.57February 2010), the tumor size GTV (Gross tumor volume) is the tumor in The size and position in the image; the spread range CTV (Clinical target volume) is the possible spread range of the tumor; the movement deviation range ITV (Internal target volume) includes the deviation range of internal displacement; the treatment boundary range PTV (Planning target volume) is the treatment plan The boundary range in . Since external radiotherapy or other externally fixed brachytherapy methods cannot accurately fix the radiation source relative to the tumor, additional normal tissues will be exposed to radiation doses (ITV, PTV range). On the other hand, brachytherapy requires several For each course of treatment, precise positioning is required to ensure that the tumor receives a consistent therapeutic dose in each course of treatment and maintain the consistency and reproducibility of treatment.

In order to make the distribution of radiation dose in the affected area more uniform and avoid side effects, the catheter device has developed a way to increase the diameter of the catheter so that the radiation source is placed in the middle of the catheter. After placing the thickened catheter into the body cavity, the distance between the surrounding tissue and the radiation source is the same. For example, Elekta's Bonvoisin-Gerard Esophageal Applicator product, the catheter is to open the body cavity in a way that the entire catheter is thickened to facilitate the administration of the radiation source. However, although the entire segment is thickened to center the radiation source, the shape of the tumor is different, and the size of the tumor growth in different segments is different. The entire segment of the catheter is thickened with the same range, because the dose of the radiation source is inversely proportional to the square of the distance. , when part of the tumor growth is limited to the superficial part, more normal tissue parts are irradiated, causing side effects. However, in a place with a large tumor and severe stenosis, if the tube wall is stretched with the same size, it may cause the tube wall to rub against the stenotic esophageal wall tumor and cause bleeding, which will make the patient feel uncomfortable. And because the esophagus is a smooth and peristaltic organ, if the whole section of the catheter is thickened without ups and downs, it is easy to cause the catheter to slip, and the fixation effect is not good.

Elekta’s other catheter, the Standard Nasopharyngeal Applicator Set, is to place the catheter into the patient’s body cavity, and then inflate the body cavity with a balloon, as shown in Figure 3(a). However, the additional balloon shrinks before it is inflated As shown in Figure 3(b), it will rub against the wall of the body cavity when it enters the body cavity, which may cause discomfort to the patient and even cause damage to the cavity wall.

Taking the catheter disclosed in US Patent No. US6575932B1 as an example, it has two airbags that can be inflated separately to fix the catheter in the body cavity; the distance between the airbags is determined by stretching the tube in the middle of the two balloons, and the middle tube is provided with an opening Can be administered. However, if this catheter is used for brachytherapy, the middle tube is used for the radiation source to pass through. If the distance between the two balloons is too short, the radiation source is only suitable to stay in this short position to ensure that the radiation source is centered and the dose is uniform. When there is a diffuse tumor in the lumen, and the tumor length is more than 3 cm, it is necessary to repeatedly place the catheter and radiation source, which may easily cause injury to the cavity, and multiple operations consume a lot of time and the patient's energy. Dose connection is quite difficult. Dose overlap is likely to occur at the intersection of two adjacent irradiation ranges, resulting in excessive dose, which may cause irreparable damage and increase unnecessary risks. If the distance between the two airbags is long, it will be difficult to fix the position of the entire tumor. The patient may easily slip the catheter due to breathing or movement, changing the position of the radiation source, so that the tumor cells cannot receive enough therapeutic dose, and normal tissues receive too much Doses cause damage.

The design of the catheter of Chinese Patent Publication No. CN202387089U is to try to fix the tumor when the length of the tumor is more than 3 centimeters. The catheter has a catheter body, a developing ring, at least two balloons, a balloon cavity, a balloon filling channel, a balloon injection port, a guide wire (guide wire) channel, and a guide wire channel injection port. The number of the balloon injection port and the balloon filling channel is the same as that of the balloon. The diameters of the balloons are the same and the shape is a long cylinder. During treatment, the end balloon is filled first, and then the adjacent balloons are filled sequentially on this basis; thus, on the basis of the expansion of the end balloon, the balloon can be extended directly without replacing the balloon catheter. The overall length of the capsule, reaching the tumor when the length of the fixed tumor is more than 3 cm. However, due to the need for guide wires to assist the treatment, it increases the trouble in operation. Moreover, the balloon is an additional long cylindrical airbag. Once the amount of inflation is insufficient during inflation, or the adhesion of the balloon is offset when it is connected to the catheter, the balloon may not inflate evenly, so that the radiation source cannot be maintained at the exact center of the catheter. Reduced reproducibility of treatment plans.

Among the operational difficulties, the treatment of esophageal cancer is the most likely to cause discomfort to patients. Brachytherapy for esophageal cancer may cause side effects such as acute bleeding due to the high dose of radiation therapy, so it must be used with great care in clinical practice. At present, nasogastric tube is often used for treatment in clinic, but because of its small diameter, poor fixation effect, and the inability to center the radiation source in the lumen, the nasogastric tube will be randomly attached to the esophageal wall, making the radiation source consistent with normal The distance between the esophageal wall is too close to cause too high a dose, resulting in radiation hotspots, which are likely to cause serious side effects and affect doctors' willingness to use. In order to avoid the occurrence of serious side effects, the American Brachytherapy Society of the United States proposes that the diameter of the brachytherapy tube should be at least 10 mm. Elekta and Varian have also developed this kind of treatment tubing with thickened diameter, but the thickened tubing needs to be inserted from the mouth instead of the nasal cavity, and may squeeze the tumor. And clinically, it needs to cooperate with gastroenterologists to operate, and with the assistance of endoscope, guide wires are inserted into the body cavity from the mouth. The deployment of the guide wire increases the working procedures, and it is inserted through the mouth, which may easily cause vomiting reflex or swallowing reaction to change the position of the catheter, and cause discomfort to the patient. Therefore, sedatives or anesthesia must be administered, and the patient must also lie on his side. Increase operational inconvenience and risk. However, after obtaining the tumor imaging data, the doctor decides the patient’s treatment plan (determines the location and duration of the radiation source), and then moves the patient to the bed for brachytherapy. At this time, as long as the patient’s lateral curvature changes , the applicability of the doctor's treatment plan will be reduced, making the treatment imprecise.

The multi-balloon catheter also has a catheter provided by US Patent No. US6527692B1. This catheter is used for brachytherapy in blood vessels. It also has more than two balloons and can be inflated/filled separately. The purpose of filling separately is to fix the position of the catheter. At the same time, because the other unused balloons can be expanded in real time, allowing blood to pass through the vessel in the untreated segment without obstruction. However, the shape of the balloon is a donut shape or a spiral shape, and it is added to the catheter. A certain amount of gas/liquid needs to be filled to maintain the supporting shape. Therefore, in the case of small volume filling In this case, it is easy to cause uneven filling and offset, and the source tube cannot maintain the center. However, if the air volume is too large to maintain the shape of the hollow cylindrical body or the helical air bag, if the body cavity is narrowed due to the overgrowth of the tumor, it may cause discomfort to the patient, and even cause the tumor to rupture and bleed. And clinically, when placing the catheter, even if the balloon added to the catheter is not inflated, when it is inserted into the narrow cavity of the patient, the smoothness of the insertion will be affected by the existence of the extra balloon. It will rub against the wall of the body cavity, causing discomfort to the patient and even damage to the cavity wall.

A catheter provided by U.S. Patent Publication No. 5910101 also has more than two airbags and can be inflated/filled respectively. The purpose of more than two airbags is to give brachytherapy even to the bend of the blood vessel. What is important is that the dose of the radiation source is inversely proportional to the square of the distance. Although the multi-balloon design of the catheter gives the possibility of giving treatment at the bend, it also fails to solve the problem of insufficient inflation during inflation, or the adhesion of the balloon to the catheter. There is an offset, which can prevent the balloon from inflating evenly, making it impossible to maintain the source in the exact center of the catheter. Also applicable to vascular proximity therapy, there is also a catheter for proximal therapy provided by US Patent Publication No. US7384411B1. In order to maintain the smooth passage of blood, the catheter uses a channel structure (communication structure) design on the catheter. The channel structure There is a channel on it, so that after the catheter is placed in the body, the patient's blood can pass through smoothly, avoiding blockage of the blood vessel, and it can also be used in the treatment of the respiratory tract to allow the gas required by the patient to pass through. However, when the catheter uses a balloon, it is added to the periphery of the channel structure, which increases the volume of the catheter. When it enters the body cavity, it may also rub against the body cavity wall, causing discomfort to the patient or even damage to the cavity wall.

At present, catheters have the above-mentioned shortcomings. Therefore, how to design a catheter that can reduce the range of normal tissue irradiated by radiation, avoid side effects, and meet the needs of multiple tumors or diffuse tumors without requiring multiple operations. It takes a lot of time and energy of the patient, and does not require the assistance of a guide wire, avoids multiple operations, and does not add an external balloon or increase the diameter of the tube to achieve the above goals, so as to avoid affecting the patient's narrow cavity. A kind of catheter of smoothness or discomfort is actually a problem to be solved urgently at present.

Contents of the invention

This case provides a catheter device, which includes: a tubular structure; a plurality of fluid flow tube structures, each having a proximal direction and a distal direction, and arranged along a first axial direction of the tubular structure; a plurality of node units arranged along the direction of the first axis of the tubular structure, wherein a section is formed between every two adjacent node units; and an outer layer element, the outer layer element covers a plurality of the node units, so that the interval formed between two adjacent node units forms a space.

According to the above idea, there are a plurality of said outer layer elements, and each of the plurality of said outer layer elements respectively wraps a said section formed by two adjacent said node units, so that the two adjacent said node units The intervals formed between the node units form a space.

According to the above idea, the number of the fluid flow tube structures is more than four; the number of the node units is more than five; and the number of the outer elements is more than four.

According to the above concept, wherein said plurality of fluid flow tube structures has a control element in said proximal direction, said control element is used to connect said outer layers of said fluid flow tube structures in said distal direction The components expand and contract independently at the positions of the intervals.

According to the above idea, wherein the plurality of fluid flow tube structures have a plurality of control elements in the proximal direction, and the plurality of control elements are independently arranged in the proximal direction of the plurality of fluid flow tube structures Above; the control element is used to independently expand and contract the outer elements connecting the distal ends of the fluid flow pipe structure at the positions of the intervals.

According to the above idea, wherein the node unit is a hollow cylinder structure, wherein the hollow space allows the tubular structure to pass through the node unit along the first axis direction; and the wall of the hollow cylinder is along the A channel is provided in the first axis direction, and the channel allows the fluid flow pipe structure to pass through the node unit along the first axis direction.

According to the above idea, the outside of the hollow cylinder structure of the node unit also has a connecting ring; the outer element is connected to the node unit through the connecting ring, so that two adjacent The interval formed between the node units is a closed space.

According to the above idea, there is also an outer ring structure, so that the outer layer element is fastened to the connecting ring part.

According to the above idea, wherein the node unit is a hollow cylinder structure, wherein the hollow space allows the tubular structure to pass through the node unit along the first axis direction; and the wall of the hollow cylinder is along the A channel is provided in the direction of the first axis, and the channel allows the fluid flow pipe structure to pass through the node unit along the direction of the first axis; wherein the hollow cylinder structure of the node unit also has a A protruding ring portion; a plurality of the outer layer elements are connected to the protruding ring portions of two adjacent node units along the direction of the first axis, so that two adjacent node units form a The intervals form a space.

According to the above concept, at least two of the fluid flow pipe structures have different lengths, so that the plurality of the fluid flow pipe structures are connected to different intervals.

According to the above idea, each of the plurality of fluid flow tube structures also has an opening, wherein the positions of the openings are respectively set at different positions of the intervals, so that the different fluid flow tube structures pass through the respective The openings deliver fluid to the different intervals.

The present invention further provides a brachytherapy system, comprising: an afterloading treatment apparatus; a catheter device as described in the above concept, connected to the afterloading treatment apparatus; and a radiotherapy source, composed of The afterload therapy device delivers the radiation therapy source into the tubular structure of the catheter device.

According to the above idea, it further has a tumor imaging device, and the afterload therapy device decides to release the radiotherapy source to the position of the interval of the tubular structure according to the tumor imaging device.

According to the above idea, wherein, the tumor imaging equipment includes but not limited to X-ray imaging, fluoroscopy, computerized tomography, positron tomography, single photon emission tomography, and nuclear magnetic resonance imaging.

Description of drawings

Figure 1 is a graph showing the relationship between radiation dose and tissue toxicity.

Fig. 2 is a schematic diagram of radiation range and displacement deviation during external radiotherapy.

Fig. 3(a) is a schematic diagram of the catheter balloon inflated in the prior art.

Fig. 3(b) is a schematic view before inflation of the catheter balloon in the prior art.

FIG. 4 is a schematic structural view of an embodiment of the catheter device of the present invention.

FIG. 5 is a schematic diagram of an embodiment of the fluid flow tube structure with different lengths in the present invention.

Figure 6(a) is a perspective view of a node unit.

Figure 6(b) is a schematic front view of the node unit.

Figure 6(c) is a schematic side view of the node unit.

Fig. 7(a) is a three-dimensional schematic diagram of an embodiment in which the node unit has a connecting ring.

Fig. 7(b) is a schematic front view of an embodiment in which the node unit has a connecting ring.

Fig. 7(c) is a schematic side view of an embodiment in which the node unit has a connecting ring.

Fig. 8(a) is a schematic diagram of an embodiment of the outer ring structure.

FIG. 8( b ) is a schematic diagram of the connecting ring part of the node unit connected to the outer ring structure.

FIG. 8( c ) is a schematic diagram of the connecting ring part of the node unit connected to the outer ring structure.

FIG. 9 is a schematic diagram of an embodiment in which a node unit is connected to an outer ring structure and outer elements.

Fig. 10(a) is a schematic perspective view of an embodiment with protruding rings on the node unit.

Fig. 10(b) is a schematic front view of an embodiment with protruding rings on the node units.

Figure 10(c) is a schematic side view of an embodiment with protruding rings on the node unit.

Fig. 11 is a schematic diagram of a node unit with a protruding ring connected to an outer element.

Figure 12 is a schematic diagram of expansion of the outer layer element.

FIG. 13 is a schematic diagram showing that the outer elements of the catheter device in this case independently expand and contract to control the size to achieve a conformal tumor.

detailed description

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as understood by one of ordinary skill in the art.

This case "a kind of catheter device" will allow those with common knowledge in this field to understand its creative spirit through the following embodiment descriptions, and can be completed accordingly.

The implementation of this case is not limited by the following examples.

Please refer to FIG. 4 , a schematic diagram of an embodiment of the catheter device 10 in this case. There is a tubular structure 11 in the middle for placing the radiation source 12 . A plurality of fluid flow pipe structures 13 are arranged along the first axis direction of the tubular structure 11, wherein the "first axis direction" in the embodiment of this case refers to the long side of the catheter device as the axis direction. There are a plurality of node units 15 on the catheter device 10, which are arranged along the first axial direction of the tubular structure 11, wherein a section 1a is formed between every two adjacent node units 15, and each section 1a is connected to the outer layer element 14 A space 1b is formed. A plurality of fluid flow tube structures 13 each have an opening 17 in its distal direction 18 and each have an independent control element 16 in its proximal direction 19. In some embodiments, the control element 16 can be a medical pump, Syringes, or injection-type devices, etc. The control element 16 sends fluid (not shown) into the fluid flow pipe structure 13 to its opening 17, and the fluid emerges from the interval 1a between two adjacent node units 15 and fills the space 1b, so that the outer layer element 14 expansion and contraction, to achieve the effect of positioning. Since the positions of the openings 17 are set in different intervals 1a, different fluid flow tube structures 13 can send fluids to different intervals 1a through the respective openings 17, so that the expansion and contraction of the outer layer elements 14 can be controlled separately. degree.

The tubular structure 11, the fluid flow pipe structure 13, and the outer layer element 14 are made of soft and bendable materials, such as silicone, latex, plastics such as PVC, PU, PP, PE, PTFE, etc. biocompatible material or its composition, and make the outer layer element 14 expandable after filling. The tubular structure 11 and the fluid flow pipe structure 13 can be designed with different lengths and calibers according to different affected parts, and the interval 1a formed by two adjacent node units 15 can also be designed with unequal distances according to requirements.

In an embodiment for esophageal cancer, the catheter device 10 can be designed to have a length of 900-1400 mm, preferably 900-1200 mm. The outer diameter of the tubular structure 11 can be designed to be 2-6mm, preferably 5.3mm, and the inner diameter can be 1-5mm, preferably 2.0-2.1mm, so that it can be inserted into a white tube (lumencath) (not shown) that assists in placing the radiation source. diagram) size.

If the affected part is the rectum, the length of the catheter device 10 can be designed to be 300-600mm, preferably 400-600mm. The outer diameter of the tubular structure 11 can be designed to be 6-15mm, preferably 10mm, and the inner diameter can be 1-5mm, preferably 2.0-2.1mm, so as to be able to insert a white tube (lumencath) that assists in putting the radiation source (not shown in the figure) Shown) the size is enough.

In some embodiments, the fluid flow pipe structure 13 has the same length as the tubular structure 11, and at least one opening 17 is located in different intervals 1a. The inner diameter of the fluid flow pipe structure 13 may be between 0.2-3 mm, preferably 0.7 mm. In the embodiment for esophageal cancer, the distance between the center of the fluid flow pipe structure 13 and the center of the tubular structure is 0.6-3 mm, preferably 1.8-1.9 mm. In the embodiment for rectal cancer, the distance between the center of the fluid flow pipe structure 13 and the center of the tubular structure is 2-5 mm, preferably 3.9 mm.

The material of the node unit 15 can also be composed of silicone, latex, plastics such as PVC, PU, PP, PE, PTFE, etc. and other biocompatible materials, and can also be further added with X-ray imaging line or add barium sulfate and other developing materials. In the embodiment for esophageal cancer, the length of node unit 15 can be 1-15mm, preferably 1-8mm, in the embodiment for rectal cancer, the length of node unit 15 can be 1-15mm, relatively The best is 5-15mm.

In order to make the space between the tubular structure 11 and the node unit 15, between the fluid flow pipe structure 13 and the node unit 15, and between the outer layer element 14 and the node unit 15 completely airtight, so that the outer layer element can expand and contract smoothly, an adhesive can be used. aids (not shown).

In some embodiments, a plurality of fluid flow pipe structures 13 may be connected by a single control element (not shown), such as a computer-controlled pumping device, to connect multiple fluid flow pipe structures 13, and independently control each remote through a valve. Outer elements 14 joined end-wise 18 . In an embodiment for esophageal cancer, the outer member 14 may have a length of 5-20 mm, preferably 16.5 mm, optionally expanded to a diameter of 30 mm or less. In an embodiment for rectal cancer, the outer layer member 14 may have a length of 20-50 mm, preferably 30 mm, optionally expanded to a diameter of 50 mm or less.

5 is a schematic diagram of another embodiment of the catheter device 10 of the present case, wherein the fluid flow pipe structures 13 have different lengths, so that different fluid flow pipe structures 13 are connected to different intervals 1a and filled into the space 1b. To achieve the respective expansion and contraction of the outer layer elements 14 and the respective regulation of the expansion and contraction degree.

Fig. 6(a), Fig. 6(b) and Fig. 6(c) are respectively a three-dimensional schematic diagram, a front schematic diagram and a side schematic diagram of the node unit 15 of this case. Please refer to Fig. 2 and Fig. 6 (a), Fig. 6 (b), Fig. 6 (c), node unit 15 is a hollow cylinder structure, wherein empty space 33 can be available for tubular structure 11 to pass node unit 15 along, in The column wall 31 of the node unit 15 is provided with a channel 32 so that the fluid flow pipe structure 13 can pass through the node unit 15 . The space 1b formed by the interval 1a between two adjacent node units 15 and the outer layer element 14 can be sealed, and the outer layer element 14 can be expanded and contracted due to being filled with fluid, and the tubular structure 11 can also be connected with the fluid. The flow pipe structure 13 passes through the node unit 15 .

Fig. 7 (a), Fig. 7 (b), Fig. 7 (c) are the three-dimensional schematic diagram, the front schematic diagram, the side schematic diagram that the node unit 15 of this case has the ring portion 41 respectively; Fig. 8 (a), Fig. 8 (b), FIG. 8( c ) is a schematic diagram of connecting the connecting ring portion 41 of the node unit to the outer ring structure 51 . In this embodiment, the connecting ring portion 41 is an annular groove, which can be combined with the outer ring structure 51 of FIG. 8( a ), as shown in FIGS. 8( b ) and 8 ( c ). In some embodiments, the outer ring structure 51 can be a rubber ring with elastic binding force, or an elastic biocompatible material, or an inelastic plastic or metal.

FIG. 9 is a schematic diagram of an embodiment in which the node unit 15 is connected to the outer ring structure 51 and the outer element 14 . As shown in Figure 9, two adjacent node units 15 fix the outer layer element 14 by connecting the ring portion 41 and the outer ring structure 51, and form a space 1b, so that fluid (not shown) can enter the space 1b The outer layer element 14 of the space 1b is expanded and contracted. In this embodiment, the number of the outer layer element 14 can be one, and then the pressure segments given by the outer ring structure 51 and the connecting ring portion 41 of the node unit 15 can reach the outer layer elements 14 of different intervals 1a. The purpose of expansion and contraction respectively.

In the embodiment of FIG. 10, the node unit 15 has a protruding ring portion 71. FIG. 10(a), FIG. 10(b), and FIG. Schematic, side view. FIG. 11 is a schematic diagram of the outer element 14 connected to the protruding ring portion 71 when the node unit 15 has the protruding ring portion 71 . The outer element 14 is connected to the protruding ring portion 71 of two adjacent node units 15, so that the interval 1a formed between the two adjacent node units 15 forms a closed space 1b, allowing the outer The layer element 14 can expand and contract due to filling with fluid. In this embodiment, the number of outer layer elements 14 can be multiple, ranging from 4 to 16 depending on the requirement, and they are respectively connected to the intervals formed between two different adjacent node units 15 . Fig. 8 shows that the outer layer element 14 wraps the intersection 1a in a film shape, wherein the film thickness of the outer layer element 14 can be preferably between 0.1-2 mm. In the embodiment for esophageal cancer, the length of the outer layer element 14 can be 5-50 mm, preferably 5-20 mm, and in the embodiment for rectal cancer, the length of the outer layer element 14 can be 5-50 mm, Preferably it is 20-50mm.

FIG. 12 is a schematic diagram showing that the outer elements 14 of the catheter device 10 of the present invention can expand and contract respectively due to the existence of the node units 15 . In this case, because it can independently control whether different spaces 1b are filled with fluid and the amount of each filling, it can independently control the expansion and contraction degree of each outer layer element 14. When the size of tumor growth in different sections is different, it can be adjusted according to the patient's body cavity. According to the actual demand of the tumor growth situation in the body cavity, a small amount of fluid expansion outer layer element 14 is filled in the narrow part of the body cavity (caused by a larger or more prominent tumor), and the superficial part of the tumor growth (the esophageal lumen is less narrow). Filling with more fluid makes the expansion degree of the outer layer element 14 larger, so as to achieve the purpose of killing tumors with less radiation dose, so as to reduce side effects. And when the outer layer element 14 is attached to the catheter, due to the design of the node unit 15, the outer layer element 14 can be accurately bonded to the catheter after using an adhesive (not shown), which improves the prior art in adding a balloon to the catheter When the airbag is inflated, it is easy to cause the airbag to be inflated unevenly due to the offset of the adhesive, which may cause the problem of radiation hot spots.

In this case, due to the design of the outer layer element 14 and the node unit 15, only a small amount of inflation is required to have an expansion effect, so when determining the degree of expansion, a smaller expansion amount can be selected to improve the prior art shown in Figure 3 (b). The collapsed airbag before inflation needs to be filled with more than a certain amount of fluid to maintain the shape of the airbag. In this case, due to the design of the outer element 14 and the node unit 15, there is no need to add an airbag as in the previous technology, which will cause discomfort to the patient or even damage the cavity wall when entering the body cavity, which improves the insertion into the narrow cavity of the patient. smoothness of time.

FIG. 13 is a schematic diagram of the outer layer elements 14 of the catheter device 10 of the present invention expanding and contracting independently to control the size so as to achieve conformal tumor tissue 101 . After being connected to the afterload therapy device 103, the catheter device 10 (some components omitted) can determine at which position the outer layer component 14 needs to expand and contract, and the size of the expansion and contraction along the size of the tumor tissue 101 in the lumen , put into radiation source 12 again, carry out brachytherapy. Since the outer elements 14 of the catheter device 10 in this case can expand and shrink respectively, the catheter device 10 can conform to the tumor tissue 101, so that when arranging a treatment plan for a patient, the irradiation range of the tumor tissue 101 can be increased and the acceptance rate of the normal tissue 102 can be reduced. dosage, increase the cure rate of patients, and reduce side effects.

Wherein the expansion and contraction position of the outer layer element 14, and the size of the expansion and contraction are determined according to the image taken by the tumor imaging instrument 104. , Positron Tomography (PET), Single Photon Emission Tomography (SPECT), Magnetic Resonance Imaging (MRI), etc.

In the past, a 2D plane system was used for image positioning, and two images of the front and the side may be taken, which may have spatial errors. At present, it has tended to use the stereoscopic orientation method of computerized tomography. At this time, the fixation effect of the catheter device 10 in the lumen is obvious. Very important, because the catheter device 10 conforms to the shape of the tumor tissue 101, the catheter device 10 and the tumor tissue 101 have a similar fitting effect, which has a good fixation effect, making the treatment plan more accurate, and successfully solving the problem of the patient's breathing. 10 Movement, or because of the movement between the tumor imaging irradiation procedure and the radioactive source placement treatment procedure, the problem of reducing the accuracy of the treatment plan.

In summary, with known technologies, such as Elekta's Bonvoisin-Gerard Esophageal Applicator product, Standard Nasopharyngeal Applicator Set product, U.S. Patent No. US7384411B1, U.S. Patent No. US6575932B1, Chinese Patent No. CN202387089U, U.S. Patent No. Compared with the catheters disclosed in Patent Publication No. 5910101, etc., this case increases the fixation effect, reduces the range of normal tissue irradiated by radiation, and reduces side effects. 41 segmented, or segmented with a plurality of outer layer elements 14, the outer layer elements 14 reaching different intervals 1a can be expanded and contracted separately, for example, there are 4-16 outer layer elements 14 that can be expanded and contracted respectively, In the case of multiple tumors or diffuse tumors, the present invention can be fixed where needed, and treat multiple diffuse cancer segments simply by moving the radiation source, without requiring repeated operations to consume a lot of time and disease. Also because the degree of expansion and contraction of the outer layer elements 14 and the size can be independently controlled, the degree and size of the expansion and contraction of different outer layer elements 14 can be determined according to the appearance of the tumor in the affected part during use, so that the entire segment The tumor is fixed in a conformal manner, so that even if the patient moves when breathing or moving, the catheter device 10 has fixed the tumor in a conformal manner, and can move with the tumor tissue without slipping, and will not cause changes in the relative position of the tumor tissue, increasing physician Accuracy of treatment planning.

The technical features of the present invention can be used in any catheter treatment that requires opening the body cavity. The following will take the treatment of esophageal cancer and rectal cancer as an example to describe the application steps to assist those with ordinary knowledge in the technical field to understand the possible aspects of the present invention. Application mode, and under the situation of not exceeding the patent scope of this case, replace other use steps and apply the present invention:

Esophageal cancer:

Catheter device 10 is inserted nasally into the esophagus. In the state where the outer element 14 has not yet expanded or contracted, the catheter device 10 can be smoothly inserted from the nasal cavity to the esophagus without the interference of an external air bag, so it does not need to be inserted from the oral cavity. After the catheter device 10 is inserted into the esophagus, it is fixed outside the nostrils with an adhesive tape.

A white tube (lumen cath, not shown in the figure) is inserted into the tubular structure 11 of the catheter device 10 until the end, and the lumen cath (not shown in the figure) is glued and fixed to the tubular structure 11 with adhesive tape.

Then connect the open end of the white tube (not shown in the figure) to the back-loading therapeutic apparatus 103, and put in a simulated radiation source that can measure the relative depth in the lumen and can be visualized in the CT image.

Capture the image scout view (recombined planar image) of the patient’s part, watch the distribution range of the simulated radiation source, compare the tumor range of the planar image reconstructed from the computerized tomography image of the treatment planning system, and determine the corresponding expanded outer layer component of the catheter device 10 14 positions and degrees of expansion. Because the catheter device 10 of this case has enough outer layer elements 14 (for example: 8 expandable outer layer elements), even if it is a diffuse tumor, it does not need to do any movement after being placed in the catheter device, which enables the patient to Feel comfortable even under anesthesia.

Part of the outer element 14 is inflated and then scanned for computerized tomography to confirm that the expansion is appropriate. If necessary, the size is adjusted, and the computerized tomography is re-scanned after modification.

The computed tomography image is sent to the treatment planning system to depict the tumor location and tumor range when the outer element 14 is inflated, as well as its surrounding normal tissues (such as lungs, heart, spinal cord, etc.).

According to the various tumor sizes and shapes of patients, 3D treatment plans (dose calculation) are made to ensure that the tumor area receives sufficient doses and the normal tissue receives doses within a safe range.

Treatment is performed, irradiation is administered.

rectal cancer:

Put the catheter device 10 from the patient's anus to the rectum, and stick the catheter device 10 outside the anus with an adhesive tape.

Put a white tube (not shown in the figure) into the tubular structure 11 of the catheter device 10 until the end, and stick the white tube (not shown in the figure) to the tubular structure 11 with adhesive tape.

Then connect the open end of the white tube (not shown in the figure) to the back-loading therapeutic apparatus 103, and put in a simulated radiation source that can measure the relative depth in the lumen and can be visualized in the CT image.

Capture the image scout view (recombined planar image) of the patient’s part, watch the distribution range of the simulated radiation source, compare the tumor range of the planar image reconstructed from the computerized tomography image of the treatment planning system, and determine the corresponding expanded outer layer component of the catheter device 10 14 positions and degrees of expansion. Because the catheter device 10 of this case has enough outer layer elements 14 (for example: 8 expandable outer layer elements), even if it is a diffuse tumor, it does not need to do any movement after being placed in the catheter device, which enables the patient to Feel comfortable even under anesthesia.

Part of the outer element 14 is inflated and then scanned for computerized tomography to confirm that the expansion is appropriate. If necessary, the size is adjusted, and the computerized tomography is re-scanned after modification.

The computed tomography image is sent to the treatment planning system to depict the tumor location and tumor range when the outer element 14 expands, as well as its surrounding normal tissues (female such as uterus and ovary; male such as prostate and bladder, etc.).

According to various tumor sizes and shapes of patients, 3D treatment plans (dose calculations) are made to ensure that the tumor area receives sufficient doses and the dose received by normal tissues is within a safe range.

Treatment is performed, irradiation is administered.

The present invention does not require the assistance of a guide wire, can irradiate the entire diffuse tumor in one brachytherapy, does not need to repeatedly place catheters and radiation sources, and can avoid changes in the relative position between the catheter and the tumor caused by breathing or movement of the patient , affecting the accuracy of the treatment plan; in this case, the treatment of esophageal cancer does not need to be inserted from the mouth and does not require anesthesia to the patient, and it is not an external air bag, but has an expandable outer layer element 14 and a node unit 15 and other components achieve the purpose of treatment, there is no general external airbag that will rub against the wall of the body cavity when entering the body cavity, causing discomfort to the patient or even damage to the cavity wall, which greatly improves the smoothness of insertion into the narrow cavity of the patient and solves the problem of the existing technology problems and achieve better results.

Symbol Description

catheter set 10

Tubular structure 11

Source 12

Fluid flow pipe structure 13

Outer element 14

node unit 15

control element 16

opening 17

Distal Direction 18

proximal direction 19

interval 1a

Space 1b

column wall 31

channel 32

Hollow 33

Then ring part 41

Outer ring structure 51

Protruding ring part 71

Tumor Tissue 101

Normal Tissue 102

After-load therapy device 103

Tumor Imaging Instruments 104

tumor sizeGTV

Diffusion Range CTV

Mobile Deviation Range ITV

Treatment Boundary Range PTV

Claims (14)

1. a pipe guide, it is characterised in that including:

One tubular structure；

A plurality of fluid flow tubes structures, respectively have a proximal direction and a distal direction, and along the one of described tubular structure One direction of principal axis is arranged；

A plurality of node units, along the described first direction of principal axis spread configuration of described tubular structure, the wherein adjacent institute of each two State and between node unit, form section between；And

One outer layer element, described outer layer element is coated with a plurality of described node units, makes to be formed between two adjacent node unit Described between section form a space.

2. pipe guide as claimed in claim 1, it is characterised in that described pipe guide has a plurality of described outer layer unit Part, a plurality of described outer layer elements be each respectively coated by by two adjacent described node units formed one described between section, make two Between individual adjacent described node unit formed described between section form a space.

3. pipe guide as claimed in claim 2, it is characterised in that the quantity of described fluid flow tubes structure is more than four； The quantity of described node unit is more than five；The quantity of described outer layer element is more than four.

4. pipe guide as claimed in claim 1 or 2, it is characterised in that described a plurality of fluid flow tubes structures in described closely Having a control element on extreme direction, described control element is for making the described distal direction of described fluid flow tubes structure link Described outer layer element, the most independent breathing of fragment position between described.

5. pipe guide as claimed in claim 1 or 2, it is characterised in that described a plurality of fluid flow tubes structures in described closely Having a plurality of control element on extreme direction, a plurality of described control elements are each independently disposed to described a plurality of fluid flow tubes On the described proximal direction of structure；The institute that described control element links for making the described distal direction of described fluid flow tubes structure State outer layer element, the most independent breathing of fragment position between described.

6. pipe guide as claimed in claim 1 or 2, it is characterised in that described node unit is a hollow cylinder structure, its Middle vacancy passes through described node unit for described tubular structure along described first direction of principal axis；And on the post jamb of described hollow cylinder Being provided with a passage along described first direction of principal axis, described passage passes through along described first direction of principal axis for described fluid flow tubes structure Described node unit.

7. pipe guide as claimed in claim 6, it is characterised in that outside the described hollow cylinder structure of described node unit Portion also has a then ring portion；Described outer layer element links through described then ring portion and described node unit, make two adjacent Between described node unit formed described between Duan Weiyi confined space.

8. pipe guide as claimed in claim 7, it is characterised in that also there is an outer ring structure, make described outer layer element button Together in described then ring portion.

9. pipe guide as claimed in claim 2, it is characterised in that described node unit is a hollow cylinder structure, wherein Vacancy passes through described node unit for described tubular structure along described first direction of principal axis；And edge on the post jamb of described hollow cylinder Described first direction of principal axis and be provided with a passage, described passage passes through institute for described fluid flow tubes structure along described first direction of principal axis State node unit；The outside of the described hollow cylinder structure of described node unit also has one and highlights ring portion；A plurality of described outside Layer elements is connected in the described prominent ring portion of two adjacent described node units along described first direction of principal axis, makes two adjacent institutes State between node unit formed described between section form a space.

10. pipe guide as claimed in claim 6, it is characterised in that the length phase of at least two described fluid flow tubes structures Different so that a plurality of described fluid flow tubes structure each communicate with different described between section.

11. pipe guides as claimed in claim 6, it is characterised in that also each have in a plurality of described fluid flow tubes structures Have an opening, wherein said aperture position be each arranged at different described between fragment position so that different described fluid flow tubes Structure through respective described opening fluid is delivered to different described between section.

12. 1 kinds of proximity radiotherapy systems, including:

Lotus formula therapeutic instrument after one；

A kind of pipe guide as described in any one of claim 1-11, is connected on described rear lotus formula therapeutic instrument；And

One brachytherapy sources, is released the described brachytherapy sources described tubulose to described pipe guide by described rear lotus formula therapeutic instrument In structure.

13. proximity radiotherapy systems as claimed in claim 12, it is characterised in that also there is a tumor imaging instrument, institute State rear lotus formula therapeutic instrument to determine to release described brachytherapy sources to described in described tubular structure according to described tumor imaging instrument Between fragment position.

14. proximity radiotherapy systems as claimed in claim 13, it is characterised in that described tumor imaging instrument includes X-ray In imaging, fluorescent photoscope, CT Scan, positron emission tomography, single photon emission tomographic imaging and NMR (Nuclear Magnetic Resonance)-imaging One or more.