Constant-temperature heating balloon system and using method thereof

Abstract

The invention discloses a constant temperature heating balloon system and a using method thereof, the system comprises at least two balloon elements to form a closed space corresponding to a target position, a heating element is arranged in the closed space, and a temperature measuring element and a control element are respectively connected with the heating element. During use, the far-end balloon is pushed to the far end of a target and is filled, then the near-end balloon is pushed to the near end of the target and is filled, after a medicine solution is injected, the heating element heats the medicine solution at constant temperature through the control element, meanwhile, the balloon emits ultrasonic waves to act on the target position, and after treatment, the system is closed and exits. A lesion area is isolated through a double-balloon coaxial structure, a heating coil and a temperature sensor are integrated at the front end of the catheter to achieve accurate constant-temperature control, ultrasonic vibration is matched, absorption of medicine molecules in lesion tissue can be accelerated, a fixed-point efficient treatment interval is formed, and the safety and effectiveness of natural orifice obstruction treatment are remarkably improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a constant temperature heating balloon system and a method of using the same. Background Art

[0002] Obstruction of the body's natural cavities is a common clinical condition, both acute and chronic, and can be caused by tumors, inflammation, postoperative stenosis, foreign bodies, or congenital malformations. Prolonged obstruction can lead to severe damage to vital organs such as the heart, liver, and kidneys. Treatment options include radical surgical resection or minimally invasive interventional therapy, which has become the primary treatment approach. Minimally invasive treatments typically include stent implantation for malignant obstruction or balloon dilatation.

[0003] Current stent treatments primarily utilize two types of stents. Bare stents cannot prevent tumor growth into the stent, leading to high restenosis rates. Drug-eluting stents, while capable of long-term drug release, can provide targeted therapy for malignant obstructive lesions and reduce restenosis. However, drug-eluting stents have limitations, such as slow drug release and low absorption by lesion tissue, resulting in suboptimal treatment outcomes. Summary of the Invention

[0004] The purpose of the present invention is to provide a constant temperature heating balloon system and a method of using the same to solve the problems in the prior art.

[0005] To this end, the present invention provides, in one aspect, a constant temperature heating balloon system, comprising: at least two balloon elements, wherein a closed space is formed between the balloon elements, and the closed space corresponds to a target position;

[0006] a heating element, the heating element being disposed in the enclosed space and radiating heat to the surroundings when turned on;

[0007] a temperature measuring element connected to the heating element;

[0008] a control element, the control element being electrically connected to the heating element and the temperature measuring element;

[0009] When in use, the temperature measuring element detects the temperature of the target position and feeds back the temperature signal to the control element, and the control element controls the heating element to adjust the temperature.

[0010] In one embodiment, the balloon system further comprises a catheter, and the balloon element, the heating element, and the temperature measuring element are all disposed on the catheter;

[0011] The drug injection hole is provided on the catheter, and the drug solution flows out of the drug injection hole and enters the target position.

[0012] In one embodiment, the drug injection holes are provided on the catheter corresponding to the balloon components, and there are at least two drug injection holes.

[0013] In one embodiment, the injection holes are arranged axially or circumferentially around the catheter.

[0014] In one embodiment, the balloon member includes a balloon body and an ultrasonic generator disposed inside the balloon body.

[0015] In one embodiment, the sonotrode is angled toward the enclosed space.

[0016] In one embodiment, the heating element is a heating coil, which is spirally wound around the outside of the catheter, and the injection hole is provided on the outside of the catheter corresponding to at least one end of the heating coil.

[0017] In one embodiment, the heating coils are distributed outside the catheter at equal or unequal intervals.

[0018] In one embodiment, the temperature measuring element is a temperature sensor, and the temperature sensor is integrated with the heating element.

[0019] On the other hand, a method for using the balloon system is also provided, comprising the steps of:

[0020] Pushing the balloon system to push the distal balloon component to the distal end of the target position and filling the distal balloon component;

[0021] Pushing the balloon system again to push the proximal balloon component to the proximal end of the target position and inflate the proximal balloon component;

[0022] injecting a drug solution so that the drug solution enters the target location through the drug injection hole;

[0023] Turning on the control element to enable the heating element to heat the drug solution at the target location at a constant temperature;

[0024] The balloon member emits ultrasonic waves, and the ultrasonic waves act on the target position;

[0025] The balloon system is closed and withdrawn to the outside.

[0026] Beneficial effects:

[0027] The present invention provides a constant temperature heating balloon system and a method for using the same. The system isolates the diseased area through a double-balloon coaxial structure, and the heating coil and temperature sensor are integrated into the front end of the catheter to achieve precise constant temperature control. Combined with ultrasonic vibration, it can accelerate the absorption of drug molecules in the diseased tissue, forming a fixed and efficient treatment range. It avoids the problems of high restenosis rate and poor drug absorption in traditional balloon dilatation and stent treatment, and ensures the balloon dilatation performance through the independent setting of the heating element, reduces thermal damage to normal tissue, and significantly improves the safety and effectiveness of natural cavity obstruction treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0029] Figure 1 This is a schematic structural diagram of the constant temperature heating balloon system provided by the present invention.

[0030] Figure 2 This is a partial schematic diagram of the head end of the constant temperature heating balloon system provided by the present invention.

[0031] Figure 3 Schematic diagram of the distribution of drug solution in the constant temperature heating balloon system provided by the present invention.

[0032] Figure 4 This is a flow chart of a method for using the constant temperature heating balloon system provided by the present invention.

[0033] In the figure: 1. Balloon element 1; 2. Balloon element 2; 3. Heating element; 4. Drug injection hole; 5. Temperature measuring element; 6. Drug solution; 7. Catheter; 8. Control element. DETAILED DESCRIPTION

[0034] The present invention may be more readily understood by referring to the following detailed description of preferred embodiments of the present invention and the included Examples. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present invention pertains. In the event of a conflict, the definitions in this specification shall prevail.

[0035] The present invention provides a constant temperature heating balloon system and a method for using the same, which solves the problems mentioned in the background art in the existing stent treatment methods, namely, the high restenosis rate when using bare stents, and the slow release and low absorption rate of diseased tissue when using drug-eluting stents. In order to solve this problem, the existing technology generally provides a heating component inside the balloon, and controls the temperature of the drug balloon to increase the drug release rate. At the same time, the existing technology generally does not provide a heating component outside the balloon, because the heating process of the electronic components will have a certain impact on the relevant tissues, resulting in certain safety risks.

[0036] The technical concept of this application is that by setting a heating element on the outside of the balloon, the released drug solution can be heated to improve the efficiency of drug molecules being absorbed by the diseased tissue. This application sets a heating element between at least two balloon elements, and the two balloon elements are limited at both ends of the diseased tissue, so that the heating element can heat the drug solution at the target tissue more specifically during the heating process, thereby improving the absorption efficiency. At the same time, the two balloon elements are blocked at both ends of the target position, and the space between the two balloon elements is a closed area. The heating element is located in this closed area to prevent heat from diffusing to the surrounding normal tissue, thereby improving the heating efficiency and reducing the thermal damage to non-target tissue. At the same time, by expanding the balloon elements at both ends, the heating element is fixed at the target position, and the distance between the heating element and the surrounding target tissue is increased, further reducing the thermal damage to the surrounding tissue and improving safety.

[0037] Based on the above content, embodiments of the present invention are proposed.

[0038] According to the first aspect of the present invention, Figure 1-4 As shown, the present invention provides a constant temperature heating balloon system, comprising:

[0039] At least two balloon elements form a closed space between the balloon elements, and the closed space corresponds to the target position; wherein the balloon element includes a balloon structure and an internal ultrasonic generating component.

[0040] As an example, the present invention includes two balloon elements, and after the two balloon elements are expanded, they adhere to the surrounding tissues to form a closed space. By forming a closed space, the subsequently released drug solution 6 can be confined within the closed space, thereby performing targeted treatment on the diseased tissues within the closed space, which can effectively improve the treatment effect.

[0041] As an example, the present invention includes three, four or even five balloon elements, which can form a closed space between two adjacent balloon elements. Multiple closed spaces can then be formed by cooperating with multiple balloon elements, allowing for simultaneous treatment of multiple diseased tissues, thereby improving treatment efficiency.

[0042] Through the above embodiment, after the balloon element moves to the target position, multiple balloons can be used to block the target position, i.e., both ends of the diseased tissue, so that the location of the diseased tissue is a closed space, and the diseased tissue can be treated in a targeted manner, thereby improving the efficiency and effect of the treatment.

[0043] The heating element 3 is disposed in the enclosed space and radiates heat to the surroundings when the heating element 3 is turned on;

[0044] As an example, heating element 3 is exposed and disposed within an enclosed space. It should be understood that there is no obstruction between heating element 3 and the diseased tissue, such as by the inner wall of the balloon. Heating element 3 can directly heat drug solution 6 within the enclosed space. After heating drug solution 6 to an appropriate temperature, such as 40°C, the absorption efficiency of the drug by the diseased tissue can be improved. Furthermore, since heating element 3 is also within the enclosed space, when operating, it only heats the enclosed space, minimizing the heating effect on normal tissue and reducing thermal damage to normal tissue.

[0045] The temperature measuring element 5 is connected to the heating element 3;

[0046] As an example, the temperature measuring element 5 is also in a closed space. During the heating process of the heating element 3, the temperature can be detected in real time by the temperature measuring element 5, thereby controlling the heating temperature of the heating element 3 to be within a preset range.

[0047] Through the above embodiment, the temperature is detected by the temperature measuring element 5, which ensures that the drug absorption can be effectively promoted while minimizing the thermal damage to normal tissues.

[0048] A control element 8, the control element 8 is electrically connected to the heating element 3 and the temperature measuring element 5;

[0049] As an example, the control element 8 is the host computer. The temperature measuring element 5 detects the temperature at the target location and feeds the temperature signal back to the host computer. The host computer controls the heating element 3 to adjust the temperature. For example, when the preset temperature is 40°C and the temperature measuring element 5 detects that the temperature has risen to 42°C, the temperature measuring element 5 feeds the temperature signal back to the host computer. The host computer controls the heating element 3 to reduce the heating temperature or temporarily stop heating. After the temperature drops to the preset temperature, the host computer controls the heating element 3 to resume heating.

[0050] like Figure 3 As shown, in one embodiment, the balloon system further includes a catheter 7, the balloon element, the heating element 3 and the temperature measuring element 5 are all arranged on the catheter 7, and an injection hole 4 is also provided on the catheter 7, and the drug solution 6 can enter the target position after flowing out of the injection hole 4.

[0051] As an example, the balloon elements are arranged axially along the catheter 7. A portion of the catheter 7, spaced a certain distance apart from the other balloon elements, is provided with a heating element 3, a temperature measuring element 5, and a drug injection port 4. After the drug solution 6 flows out of the drug injection port 4, it can directly enter the enclosed space. After filling the entire enclosed space, or substantially filling the entire space, the heating element 3 heats the internal drug solution 6 to promote drug absorption by the diseased tissue.

[0052] like Figure 2 As shown, in one embodiment, the drug injection holes 4 are provided on the corresponding catheters 7 between the balloon components, and at least two drug injection holes 4 are provided.

[0053] As an example, two injection holes 4 are provided, one above and one below the catheter 7. It should be understood that the "above" and "below" refer to the 12 o'clock and 6 o'clock directions of the catheter 7's cross section. When the drug solution 6 is released through the injection holes 4, the release rate of the drug solution 6 can be significantly increased. In another example, multiple injection holes 4 can be provided, such as four, located at the 3 o'clock and 9 o'clock directions of the catheter 7's cross section, to further increase the release rate of the drug solution 6.

[0054] In one embodiment, the injection holes 4 are arranged axially or axially around the catheter 7. Circumferential arrangement refers to the aforementioned injection holes 4. Multiple injection holes 4 may also be provided, such as four, located at 3 and 9 o'clock on the cross section of the catheter 7. Axial arrangement refers to the provision of multiple injection holes along the axial direction, i.e., the length direction, of the catheter 7. This can increase the injection rate of the drug solution 6 into the enclosed space, thereby improving injection efficiency.

[0055] In one embodiment, the balloon component includes a balloon body and an ultrasonic generator disposed inside the balloon body, wherein the ultrasonic generator is oriented toward the closed space.

[0056] As an example, at least one end of the balloon body, i.e., the section facing the enclosed space, can be set to a conical structure. At the same time, the angle of the ultrasonic generator is facing the enclosed space, and the ultrasonic waves emitted by the ultrasonic generator can be directed toward the enclosed space, so that the effect of the ultrasonic waves can be concentrated within the enclosed space. The drug molecules are accelerated due to heating and ultrasonic vibrations and are directionally absorbed by the diseased tissue, thereby preventing the drug from diffusing with body fluids and improving the targeted treatment effect.

[0057] In one embodiment, heating element 3 is a heating coil, which is spirally wound around the outside of catheter 7, and injection port 4 is provided on the outside of catheter 7, corresponding to at least one end of the heating coil. The heating coil can be wound around the outside of catheter 7 at equal or unequal intervals, depending on the needs, allowing for more targeted treatment of lesion groups.

[0058] For example, for relatively evenly distributed lesions, the heating coils can be wound around the outside of the catheter 7 at equal intervals to achieve uniform heating of the drug solution 6. For unevenly distributed lesions, the coils can be wound around the outside of the catheter 7 at unequal intervals based on the characteristics of the lesions, allowing for more targeted heating of the drug solution 6 and improving the therapeutic effect on the lesions.

[0059] As an example, a plurality of heating coils may be provided, wherein each heating coil is evenly distributed and wound around the outside of the catheter 7, and the spacing between adjacent heating coils may be set according to the distribution characteristics of the diseased tissue and actual needs.

[0060] In one embodiment, the temperature measuring element 5 is a temperature sensor, and the temperature sensor is integrated with the heating element 3 .

[0061] For example, integrating a temperature sensor into the front end of heating element 3 allows for accurate real-time monitoring of the temperature of the heated area and feedback to the host device, achieving constant temperature control and preventing temperature fluctuations from damaging tissue or affecting drug activity. Simultaneously, integrating the temperature sensor with heating element 3 focuses heating energy on the lesioned area isolated by the dual balloons, reducing heat diffusion into normal tissue and improving heating efficiency. When combined with ultrasound, this stabilizes the temperature environment to accelerate drug molecular movement, significantly enhancing drug absorption by lesioned tissue and ensuring the safety and effectiveness of treatment.

[0062] According to a second aspect of the present invention, the present invention provides a method for using a balloon system, comprising the steps of:

[0063] Pushing the balloon system to push the distal balloon component to the distal end of the target position and inflate the distal balloon component;

[0064] Push the balloon system again to push the proximal balloon component to the proximal end of the target position and inflate the proximal balloon component;

[0065] Injecting the drug solution 6 so that the drug solution 6 enters the target location through the injection hole 4;

[0066] Turning on the control element 8 to enable the heating element 3 to heat the drug solution 6 at the target location at a constant temperature;

[0067] The balloon element emits ultrasonic waves, which act on the target location;

[0068] Close the balloon system and withdraw it to the outside.

[0069] As an example: the specific steps include:

[0070] Confirm that the host is well connected to the balloon catheter 7, the proximal end of the heating coil is docked with the host energy interface, and the temperature sensor circuit is conductive.

[0071] The host presets the heating temperature, usually set to 38-42°C, and adjusts the ultrasonic output power.

[0072] A targeted drug solution 6 is prepared and introduced through the proximal injection channel of the balloon catheter 7 to ensure that the injection hole 4 is unobstructed.

[0073] The balloon catheter 7 is pushed to the lesion area through the natural cavity of the human body (such as the esophagus, bile duct, etc.), and with the guidance of medical images (such as endoscopes, X-rays), the balloon is pushed to the distal end of the lesion location.

[0074] Liquid or gas is injected into the balloon and filled to the working pressure (such as 8-12atm), so that it adheres to the cavity wall and is fixed at the distal end of the lesion to prevent the drug from diffusing distally.

[0075] The catheter 7 is continuously pushed to deliver the balloon to the proximal end of the lesion and also inflated to the working pressure, so that the lesion area is completely isolated between the two balloons, forming a closed treatment area.

[0076] The targeted drug solution 6 is injected from outside the body through the drug injection channel. The drug is released through the upper and lower drug injection holes 4 on the catheter 7, filling the lesion cavity between the two balloons, ensuring that the drug is in full contact with the lesion tissue.

[0077] The main unit is turned on, and the heating coil heats the drug solution 6 in the lesion area at a constant temperature. The temperature sensor monitors in real time and feeds back to the main unit to maintain the preset temperature (such as 40° C.) and accelerate the movement of drug molecules.

[0078] At the same time, the host synchronously emits ultrasonic waves, which are transmitted to the diseased area through the catheter 7, and use ultrasonic vibrations to further destroy the cell membrane of the diseased tissue, thereby enhancing the drug penetration and absorption efficiency.

[0079] After the treatment is completed (the duration is set according to the condition of the lesion, such as 10-15 minutes), turn off the host heating and ultrasonic functions.

[0080] The pressure of the balloon is released one by one in turn to restore it to its deflated state.

[0081] Slowly withdraw the balloon catheter 7 from the natural cavity, observe the reaction of the lesion area and the patient's condition, and confirm that there are no complications such as bleeding and perforation.

[0082] Through the above steps, the combined design of double-balloon isolation, targeted drug injection and constant-temperature ultrasound can achieve precise treatment of the lesion area, reduce drug waste and systemic side effects, and is suitable for minimally invasive interventional treatment of natural cavity obstruction.

[0083] Finally, it should be noted that the above are only preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or make equivalent replacements for some of the technical features therein. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A constant temperature heating balloon system, characterized in that: include: at least two balloon elements, wherein a closed space is formed between the balloon elements, and the closed space corresponds to the target position; a heating element, the heating element being disposed in the enclosed space and radiating heat to the surroundings when turned on; a temperature measuring element connected to the heating element; a control element, the control element being electrically connected to the heating element and the temperature measuring element; When in use, the temperature measuring element detects the temperature of the target position and feeds back the temperature signal to the control element, and the control element controls the heating element to adjust the temperature.

2. The balloon system according to claim 1, wherein: Comprising a catheter, the balloon element, the heating element and the temperature measuring element are all arranged on the catheter; The drug injection hole is provided on the catheter, and the drug solution flows out of the drug injection hole and enters the target position.

3. The balloon system according to claim 2, wherein: The drug injection holes are arranged on the corresponding catheters between the balloon components, and at least two drug injection holes are provided.

4. The balloon system according to claim 3, wherein: The injection holes are arranged around the axial direction or the circumference of the catheter.

5. The balloon system according to claim 1, wherein: The balloon element includes a balloon body and an ultrasonic generator arranged inside the balloon body.

6. The balloon system according to claim 5, characterized in that The sonotrode is angled toward the enclosed space.

7. The balloon system according to claim 2, wherein: The heating element is a heating coil, which is spirally wound around the outside of the catheter, and the drug injection hole is arranged on the outside of the catheter corresponding to at least one end of the heating coil.

8. The balloon system according to claim 7, wherein: The heating coils are distributed outside the catheter at equal or unequal intervals.

9. The balloon system according to claim 1, wherein: The temperature measuring element is a temperature sensor, and the temperature sensor is integrated with the heating element.

10. A method for using the balloon system according to any one of claims 1 to 9, characterized in that the steps include: Pushing the balloon system to push the distal balloon component to the distal end of the target position and filling the distal balloon component; Pushing the balloon system again to push the proximal balloon component to the proximal end of the target position and inflate the proximal balloon component; injecting a drug solution so that the drug solution enters the target location through the drug injection hole; Turning on the control element to enable the heating element to heat the drug solution at the target location at a constant temperature; The balloon member emits ultrasonic waves, and the ultrasonic waves act on the target position; The balloon system is closed and withdrawn to the outside.

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