Disposable rectal protection double-lumen balloon kit for radiotherapy

Abstract

The utility model discloses a kind of disposable rectal protection double-cavity air bag kits for radiotherapy, it includes the air bag extension pipe of being internally provided with gas injection pipe and water injection pipe, gas injection pipe is equipped with air inlet and gas outlet, the air bag extension pipe located at gas outlet is equipped with inflatable air bag;Water injection pipe is equipped with water inlet and water outlet, the air bag extension pipe located at water outlet is equipped with water-filled water bag, inflatable air bag is equipped on water-filled water bag, water-filled water bag and inflatable air bag form double-cavity shielding area, the air bag extension pipe between inflatable air bag and water inlet is equipped with scale line, the air bag extension pipe equipped with scale line is equipped with slidable rubber ring, air inlet and water inlet are all equipped with irreversible valve.The utility model has the advantages of optimizing radiation shielding performance, improving air bag adaptability, and effectively improving pressure uniformity and patient comfort.

Description

Technical Field

[0001] This utility model relates to a medical device, and in particular to a disposable radiotherapy rectal protection double-cavity balloon kit for treating pelvic tumors. Background Technology

[0002] Radiation proctitis is a common complication of radiotherapy for pelvic malignancies such as cervical cancer and prostate cancer. It is caused by direct damage to the rectal mucosa and surrounding microvessels from ionizing radiation. Clinical manifestations include mucosal edema, erosion, ulceration, and bleeding. In severe cases, it can progress to intestinal wall fibrosis, stenosis, or even perforation. Studies have shown that approximately 30%-60% of patients undergoing pelvic radiotherapy develop acute radiation proctitis, of which 10%-20% develop chronic conditions, significantly reducing patients' quality of life and increasing the risk of secondary surgery.

[0003] Currently, rectal balloon technology is used to reduce the radiation dose to the rectum during radiotherapy. Its protective mechanism includes two aspects: first, anatomical displacement effect: by inflating the balloon to expand the rectal lumen, the physical distance between the rectal wall and the radiotherapy target area (such as the cervix and prostate) is increased, reducing the radiation scattering dose; second, radiation shielding effect: by using the filling material inside the balloon to absorb or scatter part of the radiation energy, the radiation dose to the rectal mucosa is reduced. Current rectal balloon techniques are divided into two categories based on the type of filling material: one is air-filled balloons. Air has weak radiation shielding ability (mass attenuation coefficient is approximately 0.001 cm² / g), requiring an increase in balloon volume (usually inflated to a diameter ≥ 5 cm) to increase the target area-rectum distance. However, over-expansion can easily lead to discomfort such as anal tenesmus and hyperactive defecation reflex. Furthermore, the balloon shape is fixed and difficult to adapt to individualized rectal anatomical curvature. The other is saline-filled water balloons. Saline has a high density (≈1 g / cm³) and excellent radiation shielding performance (mass attenuation coefficient ≈ 0.03 cm² / g), reducing the required water balloon volume. However, its incompressibility leads to uneven pressure distribution between the inflated balloon and the rectal wall. Local high-pressure areas (>30 mmHg) may compress intestinal wall microvessels, causing ischemic mucosal damage. In addition, the weight of saline (approximately 200-300 g) can easily cause traction pain in the lower rectum, affecting the patient's postural stability. In summary, existing technologies using only air or saline filling methods have significant drawbacks: air-filled balloons have low shielding efficiency and poor patient tolerance, while saline-filled balloons offer improved shielding, but their weight and pressure distribution limitations restrict their clinical application. There is an urgent need for a novel rectal protection device that optimizes radiation shielding performance while improving the anatomical fit, pressure uniformity, and patient comfort of the balloon. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of the existing technology by providing a disposable radiotherapy rectal protection double-lumen balloon kit that can optimize radiation shielding performance, improve balloon anatomical adaptability, and effectively enhance pressure uniformity and patient comfort.

[0005] To achieve the above objectives, this utility model adopts the following technical solution: It includes an airbag insertion tube, an air injection tube and a water injection tube inside the airbag insertion tube, an air inlet and an air outlet on the air injection tube, and an inflatable airbag fitted onto the airbag insertion tube located at the air outlet; the water injection tube has a water inlet and a water outlet, and a water-filled airbag fitted onto the airbag insertion tube located at the water outlet, with the inflatable airbag fitted onto the water-filled airbag, the water-filled airbag and the inflatable airbag forming a double-cavity shielding zone; the airbag insertion tube located between the inflatable airbag and the water inlet has a scale line, and the airbag insertion tube with the scale line has a sliding rubber ring, the sliding rubber ring and the scale line can achieve precise control of the airbag insertion depth, ensuring that the shielding zone covers the high-risk area of ​​the anterior rectal wall; both the air inlet and the water inlet are equipped with irreversible valves.

[0006] Both ends of the inflatable airbag are provided with inflatable airbag fixing rings between them and the airbag insertion tube; both ends of the water-filled airbag are provided with water-filled airbag fixing rings between them and the airbag insertion tube.

[0007] The airbag insertion tube is provided with an arc-shaped entry end.

[0008] The surface of the inflatable airbag is provided with a threaded pattern, which allows the airbag to form a local low-pressure area after inflation, thereby improving the uniformity of the contact pressure distribution on the rectal wall.

[0009] Due to the adoption of the above technical solution, this utility model has the following advantages: the double-cavity air-water bag composed of an inflatable air bag and a water-filled bag can effectively optimize radiation shielding performance; the inner water-filled bag can form a cylindrical radiation barrier after being filled with physiological saline; the outer inflatable air bag wraps the inner water-filled bag and injects air to form an air gap layer, and adapts to the curvature of the rectal wall through the deformation of the gas in the inflatable air bag, which can effectively reduce pressure fluctuations, further improve the adaptability of the air bag, and effectively improve pressure uniformity and patient comfort. Attached Figure Description

[0010] Figure 1 This is a schematic diagram of the structure of this utility model; Figure 2 This is a cross-sectional structural diagram of the present invention.

[0011] In the diagram, 1. Airbag insertion tube; 2. Inflation tube; 3. Water injection tube; 4. Air inlet; 5. Air outlet; 6. Inflatable airbag; 7. Water inlet; 8. Water outlet; 9. Inflatable waterbag; 10. Scale line; 11. Sliding rubber ring; 12. Arc-shaped entry end; 13. Inflatable waterbag retaining ring; 14. Inflatable airbag retaining ring; 15. Threaded pattern. Detailed Implementation

[0012] As shown in Figures 1-2, the present invention provides a disposable rectal protection double-lumen balloon kit for radiotherapy, comprising a balloon insertion tube 1, an air injection tube 2 and a water injection tube 3 inside the balloon insertion tube 1, an air inlet 4 and an air outlet 5 on the air injection tube 2, an inflatable balloon 6 fitted onto the balloon insertion tube 1 at the air outlet 5, the surface of the inflatable balloon 6 having a threaded texture 15; a water inlet 7 and a water outlet 8 on the water injection tube 3, a water-filled balloon 9 fitted onto the balloon insertion tube 1 at the water outlet 8, the inflatable balloon... Six sets are installed on the water-filled bladder 9. The air bladder extension tube 1 located between the air bladder 6 and the water inlet 7 is provided with a scale line 10. The air bladder extension tube 1 with the scale line 10 is provided with a sliding rubber ring 11. The air inlet 4 and the water inlet 7 are both provided with irreversible valves. The two ends of the air bladder 6 are provided with air bladder fixing rings 14 between the air bladder extension tube 1 and the two ends of the water-filled bladder 9 are provided with water bladder fixing rings 13 between the air bladder extension tube 1 and the air bladder extension tube 1 is provided with an arc-shaped entry end 12.

[0013] In specific usage, after sterilizing the present invention, the liquid syringe, and the gas syringe, they are packaged together in a sealed bag for later use. During use, the sealed bag is opened, and the liquid syringe and gas syringe are filled with saline and air, respectively. Then, the patient is placed in a lateral decubitus position. The medical staff holds the balloon insertion tube 1, applies medical lubricant to the patient's anus and the surface of the curved entry end 12 of the balloon insertion tube 1, and slowly inserts the balloon insertion tube 1 into the anus of the radiotherapy patient to a length of 10cm (corresponding to the mid-rectum). The sliding rubber ring 11 is firmly placed against the patient's anus, and the insertion depth is clearly recorded using the graduation line 10. The position of the inflated balloon 6 is verified by CT scan, ensuring that the inflated balloon 6 covers the anterior rectal wall area corresponding to the radiotherapy target area.

[0014] Next, remove the pre-prepared sealing cap of the liquid syringe and insert the pre-filled liquid syringe into the inlet 7 and connect it tightly. Similarly, remove the pre-prepared sealing cap of the gas syringe and insert the gas syringe into the air inlet 4 and connect it tightly. Slowly push the piston rod of the gas syringe to inject air. The air flows from the gas syringe through the air inlet 4, the air injection tube 2, and the air outlet 5 in sequence, and finally into the inflatable air bag 6. After the air bag 6 is filled with gas and expands, it forms a gas cylindrical barrier and evenly wraps the inner water-filled bag 9. Slowly push the piston rod of the liquid syringe to inject all the pre-filled saline solution. The saline solution flows from the liquid syringe through the inlet 7, the water injection tube 3, and the water outlet 8 in sequence, and finally into the water-filled bag 9. After filling, the inner saline-filled water-filled bag 9 forms a stable liquid cylindrical barrier.

[0015] Finally, remove the liquid syringe and gas syringe from the water inlet and air inlet respectively, and the radiotherapy procedure can begin. After the radiotherapy is completed, insert the two syringes back into the air inlet and water inlet respectively, draw out the air and saline, then remove the balloon insertion tube 1 from the patient's anus and dispose of it properly.

Claims

1. A disposable rectal protection double lumen balloon set for radiotherapy, characterized by, It includes an airbag insertion tube, inside which are an air injection tube and a water injection tube. The air injection tube has an air inlet and an air outlet, and an inflatable airbag is fitted onto the airbag insertion tube located at the air outlet. The water injection tube has a water inlet and a water outlet, and a water-filled airbag is fitted onto the airbag insertion tube located at the water outlet. The inflatable airbag is fitted onto the water-filled airbag. The airbag insertion tube between the inflatable airbag and the water inlet has graduation lines, and the airbag insertion tube with graduation lines has a sliding rubber ring. Both the air inlet and the water inlet are equipped with irreversible valves.

2. The disposable rectal protection double lumen balloon set for radiotherapy according to claim 1, wherein, Both ends of the inflatable airbag are provided with inflatable airbag fixing rings between them and the airbag insertion tube; both ends of the water-filled airbag are provided with water-filled airbag fixing rings between them and the airbag insertion tube.

3. The disposable rectal protection double lumen balloon kit for radiotherapy of claim 1, wherein, The airbag insertion tube is provided with an arc-shaped entry end.

4. The disposable rectal protection double lumen balloon kit for radiotherapy of claim 1, wherein, The surface of the inflatable airbag is provided with a threaded pattern.

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