Double-balloon vaginal dilation device for cervical cancer focus MRI development and operation method

Abstract

The invention discloses a double-balloon vaginal dilation device for cervical cancer focus MRI (Magnetic Resonance Imaging) development and an operation method, and relates to the field of II-type medical instruments. The main balloon is elliptical and is made of a polyurethane material, the long diameter of the main balloon after water injection is 3.5-4.5 cm, and the short diameter of the main balloon after water injection is 2.5-3.5 cm; according to the invention, through the design of cooperative dilation of the double balloons, the accuracy and efficiency of MRI development of cervical cancer lesions are significantly improved; the main balloon is made of an oval polyurethane material and is regularly expanded to be matched with the anatomical form of the vagina fornix, the oval corrugated design of the anti-skid balloon is combined, the vagina wall is effectively expanded, slippage is prevented, and attaching interference of the front wall and the rear wall of the vagina is eliminated. The dielectric constant epsilon r of the balloon material is 55 + / -5 and is highly matched with the dielectric constant epsilon r of a vaginal tissue of 50-60, normal saline containing 0.5% of Gd-DTPA is adopted as a developing solution, the focus display definition is improved to 92% + / -5% from 65% + / -12% of a traditional method, the misjudgment rate is remarkably reduced from 35%, and the examination efficiency and the patient safety are effectively improved.

Description

Technical Field

[0001] The present invention relates to the field of Class II medical devices, and specifically to a double-balloon vaginal dilator for MRI imaging of cervical cancer lesions and an operation method thereof. Background Art

[0002] In the diagnosis and treatment process of cervical cancer, MRI examination is of great significance for judging the invasion of cervical cancer lesions into the vaginal fornix and vaginal wall. However, there are many problems with current examination techniques and related instruments.

[0003] Among patients with advanced cervical cancer, 68% of cases have invasion and infiltration of the vaginal fornix and vaginal wall. When performing MRI examination on such patients, the fitting images of the anterior and posterior vaginal walls and the cervical fornix will seriously interfere with the examination results, making it difficult to clearly show the lesions of the cervical lesions invading the vaginal fornix and vaginal wall. The traditional MRI boundary misjudgment rate is as high as 35%. This high misjudgment rate will directly affect the doctor's accurate judgment of the condition, and further affect the formulation and implementation of subsequent treatment plans.

[0004] Compared with other existing types of balloon dilators for uterine cavity hemostasis, when used for MRI examination of cervical cancer, they have obvious defects. First, the size of the uterine cavity balloon does not match the size of the vaginal space, and it is difficult to closely fit with the vaginal fornix. Artifacts are easily generated during MRI imaging, which will further interfere with the doctor's observation and judgment of the lesions. Second, the single-balloon design is prone to slippage and cannot be fixed in the appropriate position, which will not only increase the examination time but also may lead to inaccurate examination results. Finally, the ordinary materials used in ordinary balloons do not match the dielectric constant of the vaginal wall, which will generate artifact areas and also affect the quality of MRI images, making it difficult to accurately observe the lesion conditions.

[0005] In addition, traditional methods such as using tamponade gauze to expand the vagina increase the patient's pain and infection risk. At the same time, the tamponade of vaginal gauze is prone to cause massive bleeding of cervical cancer lesions. In addition, vaginal gauze cannot be imaged by MRI, and signal artifacts occur after the gauze gets wet.

[0006] In view of this, a double-balloon vaginal dilator for MRI imaging of cervical cancer lesions and an operation method thereof are provided to overcome the above problems. Summary of the Invention

[0007] The purpose of the present invention is to provide a double-balloon vaginal dilator for MRI imaging of cervical cancer lesions and an operation method thereof to solve the problems raised in the above background art.

[0008] To solve the above technical problems, the double-balloon vaginal dilator for MRI imaging of cervical cancer lesions provided by the present invention includes:

[0009] Double balloon system: It includes a main balloon and an anti-slip balloon; the main balloon is oval-shaped, made of polyurethane material. After being filled with water, its major axis is 3.5 - 4.5 cm, minor axis is 2.5 - 3.5 cm, and the bursting pressure is ≥ 4 kPa, which is used for regular dilation to match the anatomical shape of the vaginal vault; the anti-slip balloon is oblate-shaped designed according to the structure of the vagina that is wider inside and narrower outside. After being filled with water, its diameter is 4.0 - 5.0 cm, the depth of the surface corrugation is 0.4 mm, and the friction coefficient μ = 0.8;

[0010] Catheter system: It is a silicone catheter with an outer diameter of 3.5 mm / inner diameter of 2.0 mm, and laser engraved scales every 1 cm from the head end;

[0011] Dual-chamber injection valve: The outside of the injection port is a Luer connector for connecting a syringe. Inside, it is equipped with a one-way valve core, made of an elastic silicone membrane, and a sealing ring is provided;

[0012] MRI compatibility: The dielectric constant ε of the balloon material r = 55 ± 5, matching the vaginal tissue ε r = 50 - 60, and the injected liquid is physiological saline containing 0.5% Gd-DTPA;

[0013] The main balloon and the anti-slip balloon are filled with water through independent channels.

[0014] Furthermore, the double balloon system further includes a double balloon pressure collaborative control algorithm, and the algorithm controls the pressure of the main balloon to be 10 kPa and the pressure of the anti-slip balloon to be 2 kPa.

[0015] Furthermore, the surface of the anti-slip balloon adopts a corrugated anti-slip quantitative design, with a corrugation depth of 0.4 mm and a wavelength of 2 mm.

[0016] Furthermore, the device has three series of sizes S / M / L, which are used to cover and match 95% of the vaginal anatomical types.

[0017] Operating method of the double balloon vaginal dilator for MRI imaging of cervical cancer lesions, including the following steps:

[0018] Preoperative preparation: Select the balloon model according to the vaginal depth. The S model is suitable for a vaginal depth ≤ 8 cm, the M model is suitable for a vaginal depth of 8 - 10 cm, and the L model is suitable for a vaginal depth ≥ 10 cm; Prepare the injection liquid by adding 0.5% Gd-DTPA to physiological saline to make a solution with a temperature of 37 ± 1 °C;

[0019] Intraoperative operation: Align the "0" point of the catheter scale with the vaginal orifice; Inject 8 ± 1 ml of injection liquid into the anti-slip balloon, control the pressure at 2 ± 0.5 kPa, and monitor through a pressure sensor; Inject 35 ± 5 ml of injection liquid into the main balloon, control the pressure at 10 ± 2 kPa;

[0020] MRI scanning: T1W I sequence scanning was used. After the scan was completed, the region of interest was outlined in the DI COM image, and the invasion volume of cervical cancer lesions was automatically calculated using software.

[0021] Furthermore, the errors during the intraoperative operation and MRI scanning were controlled to ≤0.5cm and ≤0.5mm respectively. 3 .

[0022] Furthermore, during the intraoperative operation, the ellipticity of the main balloon expansion morphology is ≥90%.

[0023] Furthermore, during the T1WI sequence scanning process, the parameters were set as TR=500ms, TE=15ms, and a slice thickness of 3mm.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] 1. Improve inspection accuracy

[0026] Clearly display the lesion: Through the coordinated water injection of the two balloons, the main balloon expands in an elliptical shape to match the anatomical morphology of the vaginal vault. The non-slip balloon fits tightly with the vaginal structure to open the vaginal wall, avoiding interference with the image of the anterior and posterior vaginal walls and the cervical vault. The dielectric constant of the balloon material matches the vaginal tissue (ε r =55±5, matching vaginal tissue ε r =50-60) and MRI compatibility design containing 0.5% Gd-DTPA saline as injection fluid (T1 signal intensity increased by 2-3 times), effectively reducing the artifact area and clearly showing cervical cancer lesions invading the vaginal wall and vault lesions. In clinical trials, 10 cases of II-

[0027] The clarity of lesion display in stage III cases has been improved from 65%±12% of traditional methods to 92%±5%, an improvement of 41.5%. This has significantly improved the lesion detection rate and the accuracy of tumor imaging staging, helping doctors to more accurately judge the condition and formulate reasonable treatment plans.

[0028] Reduce the risk of misjudgment: The traditional MRI examination has a misjudgment rate of 35% for cervical lesions invading the vaginal vault and the boundaries of the vaginal wall. The present invention effectively solves the problem of blurred lesion boundaries caused by vaginal wall adhesion, reduces the risk of misjudgment, and provides a more reliable basis for clinical diagnosis.

[0029] 2. Improve inspection efficiency

[0030] Shorten operation time: The device has a clear operation process, selects the appropriate balloon model according to the vaginal depth, and accurately locates and injects water during the operation, making the inspection process more standardized and efficient. Clinical trials have shown that the operation time is shortened from 12.3±2.8min (or 15.3±2.8min) of the traditional method to 4.1±0.9min (or 5.1±0.9min), a reduction of 66.7% (or 67.3%), reducing patient inspection time and improving the utilization rate of medical resources.

[0031] Reduce the number of repeated examinations: Since the lesions can be clearly displayed, repeated examinations due to unclear images can be avoided, further saving patients' time and medical costs and reducing their burden.

[0032] 3. Enhance user experience and security

[0033] Not easy to slip off: The anti-slip balloon adopts an oblate design, with a surface corrugation depth of 0.4mm, a friction coefficient of μ=0.8, and a diameter of 4.0-5.0cm after water injection. The structure of the vagina is wide inside and narrow outside to effectively prevent the device from slipping off. In clinical trials, there were 5 cases of slipping off with the traditional method, but no slipping occurred with the device of the present invention, which improves the stability and safety of the examination process and reduces patient discomfort and potential risks.

[0034] Improve comfort and safety: The device is reasonably designed. While stretching the vaginal wall, it will not cause additional harm to the patient, thereby improving the patient's comfort during the examination. The operation process is standardized and safe, reducing medical risks. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a schematic diagram of the double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions and the operating method of the present invention;

[0036] Figure 2 It is a schematic diagram of the structure of the balloons in the double-balloon vaginal dilation device and operation method for MRI imaging of cervical cancer lesions of the present invention.

[0037] In the figure:

[0038] 1. Main balloon; 2. Anti-slip balloon;

[0039] 3. Catheter system; 301, silicone catheter;

[0040] 4. Double-chamber injection valve; 401. One-way valve core; 402. Luer connector. DETAILED DESCRIPTION

[0041] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0042] Please refer to Figure 1 - Figure 2 , the present invention provides a technical solution:

[0043] Refer to Figure 1 -

[0044] Figure 2 As shown, a double-balloon vaginal dilator for MRI imaging of cervical cancer lesions and an operation method:

[0045] Device structure:

[0046] Double-balloon system:

[0047] (1) Main balloon 1: Oval, with a major axis of 3.5 - 4.5 cm / minor axis of 2.5 - 3.5 cm after water injection (polyurethane, Shore 85A ± 5A), burst pressure ≥ 4 kPa, regular oval expansion, matching the anatomical shape of the vaginal fornix;

[0048] (2) Anti-slip balloon 2: Designed using the structure of the vagina that is wider inside and narrower outside. The anti-slip balloon 2 is oblate, with a diameter of 4.0 - 5.0 cm after water injection (surface corrugation depth 0.4 mm, friction coefficient μ = 0.8);

[0049] (3) The two balloons are filled with water through independent channels, and the pressures are respectively controlled at 5 - 15 kPa (main balloon 1) and 1 - 3 kPa (anti-slip balloon 2).

[0050] (4) Catheter system 3: Silicone catheter 301 (outer diameter 3.5 mm / inner diameter 2.0 mm), laser engraved with scales every 1 cm from the head end (error ± 0.2 mm);

[0051] (5) Double-chamber liquid injection valve 4: The external of the liquid injection port is a Luer connector 402 for connecting a syringe; 2. One-way valve core 401: Usually made of an elastic silicone membrane, allowing liquid to flow into the balloon unidirectionally without leakage. Sealing ring: Prevent liquid from leaking from the liquid injection port. The double-chamber valve has a pressure resistance ≥ 0.5 MPa and a plug and unplug life ≥ 5000 times.

[0052] (6) MRI compatibility design: The dielectric constant ε of the balloon material r = 55 ± 5 (matching the vaginal tissue ε r = 50 - 60); The injected liquid is normal saline containing 0.5% Gd-DTPA (the T1 signal intensity is increased by 2 - 3 times).

[0053] (7) Dual-balloon pressure coordinated control algorithm (main balloon 110 kPa / anti-slip balloon 22 kPa);

[0054] (8) Quantitative design of surface corrugation anti-slip (corrugation depth 0.4mm / wavelength 2mm);

[0055] (9) Three serialized sizes (S / M / L) cover and match 95% of vaginal anatomical types.

[0056] Example 1

[0057] Preoperative preparation: A patient with stage II cervical cancer with a vaginal depth of 9 cm was selected. According to the vaginal depth, an M-type double-balloon vaginal dilation device was selected. The injection solution was prepared as required, and 0.5% Gd-DTPA was added to normal saline to prepare a solution with a temperature of 37°C.

[0058] Intraoperative procedures:

[0059] Insertion positioning: Align the catheter scale "0" point with the vaginal opening, and strictly control the error within 0.5cm during the operation. Ensure that the device is accurately placed in the vagina, laying the foundation for subsequent operations.

[0060] Water injection of anti-skid balloon 2: Use a syringe to inject 8 ml of water injection liquid into the anti-skid balloon 2 through the double-chamber injection valve 4, and use a pressure sensor to monitor the pressure to stabilize the pressure at 2 kPa. Since the anti-skid balloon 2 adopts an oblate design, the surface corrugation depth is 0.4 mm, and the friction coefficient μ = 0.8, the diameter after water injection reaches 4.5 cm (4.0-5.0 cm, here the middle value is taken), which can effectively utilize the wide inside and narrow outside structure of the vagina, closely fit the vaginal wall, and prevent the device from slipping off.

[0061] Water injection of main balloon 1: 35 ml of water injection liquid is injected into the main balloon 1, and the pressure is controlled at 10 kPa. The main balloon 1 is elliptical, made of polyurethane material (Shore85A±5A), with a bursting pressure of ≥4 kPa. After water injection, the long diameter is 4 cm (within 3.5-4.5 cm, the middle value is taken here), the short diameter is 3 cm (within 2.5-3.5 cm, the middle value is taken here), and the ellipticity of the expanded shape reaches 92%. It expands regularly to match the anatomical shape of the vaginal vault, expands the vaginal vault, and fully expands the vaginal wall.

[0062] MRI scan: The recommended T1W I sequence was used for scanning, and the parameters were set as TR = 500ms, TE = 15ms, and the slice thickness was 3mm. After the scan was completed, the region of interest (ROI) was outlined in the DI COM image, and the volume of cervical cancer lesions was automatically calculated using the software, with a measurement error of 0.4mm 3 .

[0063] Effect evaluation: By comparing with the traditional inspection method, after the patient used the device of the present invention, the comparison of various data of the patient after using the device of the present invention and the traditional inspection method is as follows:

[0064] Index Traditional method The present invention Promotion rate Clarity of lesion display 66±12％ 92％±5％ 41.5％ Operation time 15.3 ± 2.8 min 5.1 ± 0.9 min 67.3％ Slippage 5 0

[0065] The clarity of lesion display is increased from 66% of the traditional method to 92%, and the improvement rate reaches 41.5%; the operation time is shortened from 15.3 min to 5.1 min, a shortening of 67.3%; and the device does not show a slippage phenomenon during the inspection process, while there is a certain slippage situation in the traditional method. This shows that the double-balloon vaginal dilatation device of the present invention has significant advantages in improving the clarity of lesion display, shortening the operation time and preventing slippage.

[0066] Example 2

[0067] Preoperative preparation: Select a stage III cervical cancer patient with a vaginal depth of 7 cm, and select a double-balloon vaginal dilatation device of model S. Similarly, prepare normal saline containing 0.5% Gd-DTPA as the injection fluid, and keep the temperature at 37°C.

[0068] Intraoperative operation:

[0069] Insertion and positioning: Align the "0" point of the catheter scale precisely with the vaginal orifice, and control the actual error within 0.3 cm.

[0070] Inflation of the anti-slip balloon 2: Inject 7 ml of injection fluid, and maintain the pressure at 1.8 kPa. After the anti-slip balloon 2 is inflated, its diameter is 4.2 cm, and the corrugations on its surface are in full contact with the vaginal wall, enhancing the friction force and stabilizing the device.

[0071] Inflation of the main balloon 1: Inject 33 ml of injection fluid, and the pressure is 9.5 kPa. After the main balloon 1 is inflated, its major axis is 3.8 cm, its minor axis is 2.8 cm, and the ellipticity of the inflated shape is 91%, effectively dilating the vaginal fornix.

[0072] MRI scan: Use the same T1WI scan sequence, and measure the volume of lesion invasion after the scan is completed, with an error of 0.3 mm 3 。

[0073] Effect evaluation: Compared with the traditional inspection, the clarity of lesion display of this patient is increased from 65% to 92%. The following shows the effect difference between the patient using the device of the present invention and the traditional inspection method through specific data comparison:

[0074] Index Traditional method The present invention Promotion rate Clarity of lesion display 65％±12％ 92％±5％ 41.5％ Operation time 12.3 ± 2.8 min 4.1 ± 0.9 min 66.7％ Whether there is slippage Yes No

[0075] The clarity of lesion display was improved by 41.5%; the operation time was shortened from 12.3 minutes to 4.1 minutes, a reduction of 66.7%; and the device did not slip during the examination. This further verified the effectiveness and stability of the device of the present invention in patients with different vaginal depths, and could effectively improve the accuracy and efficiency of cervical cancer MRI examination.

Claims

1. A double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions, characterized in that: include: The double balloon system comprises a main balloon (1) and an anti-slip balloon (2); the main balloon (1) is oval in shape and made of polyurethane material, with a long diameter of 3.5-4.5 cm and a short diameter of 2.5- 3.5cm, bursting pressure ≥4kPa, used for regular expansion to match the anatomical shape of the vaginal vault; the anti-slip balloon (2) is an oblate shape designed using the structure of the vagina that is wide inside and narrow outside, with a diameter of 4.0- 5.0cm, surface corrugation depth 0.4mm, friction coefficient μ = 0.8; Catheter system (3): a silicone catheter (301) with an outer diameter of 3.5 mm and an inner diameter of 2.0 mm, and laser engraved scales every 1 cm from the tip; Double-chamber injection valve (4): the injection port is provided with a Luer connector (402) on the outside for connecting a syringe, and a one-way valve core (401) is provided on the inside, and an elastic silicone diaphragm is used, and a sealing ring is provided; MRI compatibility: Balloon material dielectric constant ε r =55±5, matching vaginal tissue ε r =50-60, the injection liquid is physiological saline containing 0.5% Gd-DTPA; The main balloon (1) and the anti-slip balloon (2) are filled with water through independent channels.

2. The double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions according to claim 1, characterized in that: The dual-balloon system also includes a dual-balloon pressure cooperative control algorithm, and the algorithm controls the pressure of the main balloon (1) to be 10 kPa and the pressure of the anti-slip balloon (2) to be 2 kPa.

3. The double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions according to claim 1, characterized in that: The surface of the anti-skid balloon (2) adopts a corrugated anti-skid quantitative design, with a corrugation depth of 0.4 mm and a wavelength of 2 mm.

4. The double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions according to claim 1, characterized in that: The device comes in three serialized sizes S / M / L to cover and match 95% of vaginal anatomies.

5. A method for operating a double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions, characterized in that: The following steps are involved: Preoperative preparation: Select the balloon model according to the vaginal depth. The S model is suitable for vaginal depths ≤ 8 cm, and the M model is suitable for vaginal depths of 8- 10cm, L model is suitable for vaginal depth ≥10cm; prepare the injection solution, add 0.5% Gd-DTPA into normal saline to make a solution with a temperature of 37±1℃; Intraoperative operation: Align the "0" point on the catheter scale with the vaginal opening; inject 8±1 ml of water injection liquid into the anti-slip balloon (2), and control the pressure at 2±0.5 kPa, which is monitored by the pressure sensor; inject 35±5 ml of water injection liquid into the main balloon (1), and control the pressure at 10±2 kPa; MRI scan: Use T1WI sequence scanning. After the scan is completed, outline the region of interest in the DICOM image and use the software to automatically calculate the invasion volume of cervical cancer lesions.

6. The method for operating the double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions according to claim 5, characterized in that: The errors during the operation and MRI scanning were controlled to ≤0.5cm and ≤0.5mm respectively. 3 .

7. The method for operating the double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions according to claim 5, characterized in that: During the operation, the ellipticity of the main balloon (1) in the expanded shape is ≥90%.

8. The method for operating the double-balloon vaginal dilation device for MRI imaging of cervical cancer lesions according to claim 5, characterized in that: During the T1WI sequence scanning process, the parameters were set as TR=500ms, TE=15ms, and layer thickness 3mm.

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