Balloon catheter for releasing medicine in human body cavity

Abstract

The invention discloses a balloon catheter for releasing medicine in a human body cavity. The balloon catheter comprises an outer balloon and an inner balloon located in the outer balloon. The diameter of two ends of the outer balloon is larger than that of the middle; a plurality of rows of semi-through holes are formed in the outer balloon, each row of inner semi-through holes are formed in the longitudinal direction of the outer balloon, and a cutting mark is arranged between every two adjacent semi-through holes in each row; and the inner balloon is a three-stage expansion balloon. The double-layer balloon structure is adopted, in the process that the internal pressure of the inner balloon is gradually increased to push the outer balloon to be gradually expanded, two treatment means of medicine spraying and dilation are executed at the same time, and therefore the treatment effectiveness is improved; the use efficiency of the medicine can be ensured while the medicine can accurately act on the focus; compared with an existing treatment means, the application is wider in application range and non-invasive in treatment, foreign matter does not need to be implanted, an instrument does not need to enter a human body cavity for multiple times, and discomfort of a patient during treatment can be greatly reduced.

Description

Technical Field

[0001] The invention relates to the technical field of benign cavity stenosis treatment equipment, in particular to a balloon catheter for releasing drugs in a human cavity. Background Art

[0002] Benign airway stenosis is a common respiratory disease with various causes, including tumor compression, infection, granuloma, etc. Patients often experience cough, pain, foreign body sensation and other discomforts, which can affect normal breathing in severe cases. Traditional treatment methods mainly rely on surgical removal of tumors, which has certain limitations and a long recovery period after surgery.

[0003] In order to solve the technical problems brought about by traditional surgery, technicians in this field have proposed two treatment methods: stent implantation and drug spraying:

[0004] Stent implantation therapy: Stent implantation is an effective method for treating external pressure airway stenosis. Stents are placed in the trachea to open the cavity and improve the patient's breathing status. However, this therapy has strict requirements on the selection of stent materials to avoid complications, and the stent may shift in the cavity, thus affecting the treatment effect.

[0005] Drug spray therapy: The drug spray catheter can spray the drug directly on the lesion site to treat recurrent luminal stenosis. However, there is a technical problem that the amount of drug cannot be accurately controlled and the drug can easily enter the alveoli with the patient's breathing, causing the body to absorb too much drug. Summary of the invention

[0006] To solve the above technical problems, the present invention provides a balloon catheter for drug release in a human cavity. In order to have a basic understanding of some aspects of the disclosed embodiments, a simple summary is given below. This summary is not a general review, nor is it intended to identify key / important components or describe the scope of protection of these embodiments. Its only purpose is to present some concepts in a simple form as a preface to the detailed description that follows.

[0007] The present invention adopts the following technical solution:

[0008] The present invention provides a balloon catheter for releasing drugs in a human body cavity, comprising: an outer balloon and an inner balloon located inside the outer balloon, and a drug temporary storage cavity is formed between the inner balloon and the outer balloon;

[0009] The diameters of the two ends of the outer balloon are larger than the diameter of the middle part;

[0010] The outer balloon is provided with a plurality of rows of semi-permeable holes, the semi-permeable holes in each row are opened along the longitudinal direction of the outer balloon, and a cutting mark is provided between two adjacent semi-permeable holes in each row;

[0011] The inner balloon is a three-stage expansion balloon, so that:

[0012] When the internal pressure of the inner balloon gradually increases and before reaching the first level pressure, the inner balloon pushes the outer balloon to gradually open until the two end areas of the outer balloon are in contact with the inner wall of the human body cavity, and a certain gap is left between the middle area of ​​the outer balloon and the inner wall of the human body cavity, and at the same time, the semi-permeable hole is opened, and the drug solution in the drug temporary storage cavity enters the gap through the semi-permeable hole;

[0013] When the internal pressure of the inner balloon continues to increase and reaches the first level pressure, the volume of the drug temporary storage cavity reaches a minimum value;

[0014] When the internal pressure of the inner balloon exceeds the first level pressure due to continuous increase, the outer balloon pressure will reach the second threshold in this process. At this time, if the liquid medicine in the outer balloon cannot be discharged from the micropores, the cutting marks of the outer balloon will rupture as the inner balloon expands.

[0015] Furthermore, the balloon catheter for drug release in a human body cavity further comprises: a three-lumen catheter, the outer balloon and the inner balloon are both arranged on the three-lumen catheter, a drug injection cavity is provided in the three-lumen catheter, and a drug injection hole connected to the drug injection cavity is provided on the tube wall of the three-lumen catheter;

[0016] The outer balloon comprises an outer balloon body and an outer balloon tube corner. The length of the outer balloon body is consistent with the length of the inner balloon. The injection hole is located inside the outer balloon tube corner.

[0017] Furthermore, the three-lumen catheter is divided into a handle section, a reducing section and a balloon section from the proximal end to the distal end, and the outer balloon and the inner balloon are both arranged on the balloon section of the three-lumen catheter; the outer diameter of the handle section of the three-lumen catheter is 2.6 mm, the outer diameter of the reducing section of the three-lumen catheter gradually decreases from the proximal end to the distal end, and the outer diameter of the balloon section of the three-lumen catheter is 1.8 mm to 2.0 mm.

[0018] Furthermore, the difference between the maximum diameters at both ends of the outer balloon and the minimum diameter in the middle of the outer balloon is 3 mm to 4 mm.

[0019] Furthermore, the cutting mark is a cut groove opened on the surface of the balloon wall between two adjacent semi-permeable holes in each column of the outer balloon, and the depth of the cut groove is 0.02 mm to 0.05 mm.

[0020] Furthermore, a main channel is opened in the three-lumen catheter; the distal end of the three-lumen catheter passes through the outer balloon and the inner balloon, and a head end tube is arranged at the distal end of the three-lumen catheter, the head end tube is connected with the main channel, and a first drug recovery hole is opened at the distal tube opening of the head end tube; a second drug recovery hole is opened on the three-lumen catheter, the second drug recovery hole is connected with the main channel, and the second drug recovery hole is opened on the side of the outer balloon close to the proximal end.

[0021] Furthermore, a medium cavity is provided in the three-cavity catheter, an inner balloon pressurizing hole connected to the medium cavity is provided on the tube wall of the three-cavity catheter, and the inner balloon pressurizing hole is provided inside the inner balloon.

[0022] Furthermore, the balloon catheter for releasing drugs in a human cavity further includes: two identification rings, which are arranged on the three-lumen catheter and located inside the inner balloon.

[0023] Furthermore, the balloon catheter for releasing drugs in a human cavity also includes: a drug administration handle, a main handle, a pressurizing handle and a connecting piece, and the drug administration handle, the main handle and the pressurizing handle are connected to the proximal end of the three-lumen catheter through the connecting piece, the drug administration handle is connected to the drug injection cavity, the main handle is connected to the main channel, and the pressurizing handle is connected to the medium cavity.

[0024] Furthermore, the main channel is a cylindrical cavity with an inner diameter of 1 mm, and the drug injection cavity and the medium cavity are arc-shaped cavities respectively located on both sides of the main channel.

[0025] The beneficial effects brought by the present invention are:

[0026] 1. The present application adopts a double-layer balloon structure, an outer balloon and an inner balloon are used in combination, and the structural design of the outer balloon and the inner balloon is optimized, so that when the internal pressure of the inner balloon gradually increases and the outer balloon gradually opens, the two treatment methods of spraying and expansion are performed simultaneously, thereby improving the effectiveness of the treatment;

[0027] 2. While ensuring that the drug can act accurately on the lesion, it can also ensure the efficiency of drug use, and it is convenient for doctors to accurately control the dosage of the drug, which can avoid excessive drug use and cause harm to the human body;

[0028] 3. Not limited by the type of liquid medicine, compared with the existing drug balloon and drug stent treatment methods, the application scope of this application is wider, and the treatment is non-invasive, not only does it not require the implantation of foreign objects, but it also does not require the instrument to enter the human cavity multiple times, which is less harmful to the human body and can greatly reduce the patient's discomfort during treatment;

[0029] 4. The application has a stable structure, simple operation, repeatable operation, and reduces the risk of cavity scratches. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. 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 creative work.

[0031] Figure 1 It is a schematic structural diagram of a balloon catheter for releasing drugs in a human cavity according to the present invention;

[0032] Figure 2 It is a schematic structural diagram of the balloon section of the three-lumen catheter of the present invention;

[0033] Figure 3 is a cross-sectional schematic diagram of a three-lumen catheter of the present invention;

[0034] Figure 4 is a schematic diagram of the semi-transparent hole and the cutting mark of the present invention;

[0035] Figure 5 is a schematic diagram of the second liquid recovery hole and the main channel of the present invention;

[0036] Figure 6 It is a schematic diagram of a balloon catheter for drug release in a human cavity of the present invention when it is located in a human cavity;

[0037] Figure 7 yes Figure 6 A magnified view of part A;

[0038] Figure 8 It is a schematic diagram of the outer balloon and the inner balloon when the volume of the temporary drug storage cavity of the present invention reaches a minimum value;

[0039] Fig. 9 This is a schematic diagram when the lengths of the outer balloon and the inner balloon are inconsistent and the injection hole is located inside the outer balloon;

[0040] Fig.10 It is a distribution diagram of the handle section, the diameter-changing section and the balloon section of the three-lumen catheter of the present invention. DETAILED DESCRIPTION

[0041] The embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. It should be clear that the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0042] In this embodiment, the proximal end mentioned refers to the end closer to the outside of the body, and the distal end refers to the end closer to the inside of the body.

[0043] like Figure 1-10 As shown, in some illustrative embodiments, a balloon catheter for releasing drugs in a human cavity is provided, which is suitable for treating diseases such as benign cavity stenosis, and specifically includes: a drug administration handle 100, a main handle 200, a pressurizing handle 300, a connector 400, a three-lumen catheter 500, an identification ring 600, an inner balloon 700, an outer balloon 800 and a head end tube 900.

[0044] The present application adopts a double-layer balloon structure, which is composed of an outer balloon 800 and an inner balloon 700. Specifically, the outer balloon 800 and the inner balloon 700 are both arranged on the three-lumen catheter 500, the inner balloon 700 is located inside the outer balloon 800, and a drug temporary storage cavity 1000 is formed between the inner balloon 700 and the outer balloon 800 to temporarily store the drug solution. During treatment, the drug solution is transported to the double-layer balloon structure through the three-lumen catheter 500 and stays in the drug temporary storage cavity 1000, and then discharged through the channel on the outer balloon 800 to directly act on the lesion site. Among them, the drug solution can be paclitaxel, rapamycin, hormones, etc.

[0045] The double-layer balloon structure utilizes two balloons for use together. When the internal pressure of the inner balloon 700 gradually increases and pushes the outer balloon 800 to gradually open, the volume of the double-layer balloon structure increases to provide support and the drug solution is discharged from the drug temporary storage cavity 1000 to act on the lesion site. Therefore, both spraying and expansion treatment methods can be performed simultaneously, thereby achieving dual treatment, reducing the treatment steps, and improving the treatment effect.

[0046] like Figure 3 As shown, three independent lumens are defined in the three-lumen catheter 500 , namely a main channel 510 , a drug injection channel 520 , and a medium channel 530 .

[0047] The main channel 510 is used to accommodate the guide wire when the balloon is placed to help guide the balloon catheter to the treatment site accurately, and to recover excess liquid medicine, that is, the excess liquid medicine is transported through the main channel 510 and discharged from the body in time. The injection cavity 520 is used to transport liquid medicine and inject the liquid medicine into the temporary drug storage cavity 1000. The medium cavity 530 is used to inject the medium into the inner balloon 700 to increase the internal pressure of the inner balloon 700, thereby expanding the inner balloon 700 and pushing the outer balloon 800 to open, thereby expanding the double-layer balloon structure and releasing the drug, wherein the medium can be selected to use physiological saline.

[0048] The drug administration handle 100 is used to operate and control the drug injection process. Specifically, the drug administration handle 100 is connected to the proximal end of the three-lumen catheter 500 through the connector 400, and the drug administration handle 100 is connected to the drug injection cavity 520. The tube wall of the three-lumen catheter 500 is provided with a drug injection hole 540 connected to the drug injection cavity 520. The drug solution is injected into the drug injection cavity 520 through the drug administration handle 100, transported by the drug injection cavity 520, and finally discharged into the drug temporary storage cavity 1000 through the drug injection hole 540.

[0049] The main handle 200 is used as a component for operating the balloon catheter to control the movement and positioning of the catheter, and is used to connect to a negative pressure suction device to extract residual liquid medicine left in the human body cavity. Specifically, the main handle 200 is connected to the proximal end of the three-lumen catheter 500 through a connector 400, and the main handle 200 is connected to the main channel 510 to form a continuous channel so that the guide wire can pass smoothly, and also provides a path for the recovery of liquid medicine. When the catheter is inserted before treatment, the guide wire passes through the main channel 510 through the main handle 200, and the doctor inserts the balloon catheter into the target cavity by operating the main handle 200; when the liquid medicine needs to be recovered after the treatment is completed, the negative pressure suction device connected to the main handle 200 is activated to generate negative pressure, so that the residual liquid medicine enters the main channel 510, and then the liquid medicine in the main channel 510 is extracted and discharged to the body.

[0050] The distal end of the three-lumen catheter 500 passes through the outer balloon 800 and the inner balloon 700, and a head end tube 900 is provided at the distal end of the three-lumen catheter 500, and the head end tube 900 is connected to the main channel 510 for the passage of the guide wire and the recovery of the liquid medicine. The head end tube 900 is made of a soft material to reduce the risk of damage to the inner wall of the cavity when the balloon catheter is inserted, and can improve the comfort and safety of the patient during treatment.

[0051] The distal end of the head end tube 900 is provided with a first liquid recovery hole 560 for recovering excess liquid in the distal direction of the double-layer balloon structure. Figure 5 As shown, a second drug recovery hole 570 is opened on the three-lumen catheter 500, and the second drug recovery hole 570 is connected to the main channel 510. The second drug recovery hole 570 is opened on the side of the outer balloon 800 close to the proximal end of the three-lumen catheter 500, and is used to recover excess drug in the proximal direction of the double-layer balloon structure.

[0052] When the treatment is completed and the drug needs to be recovered, the negative pressure suction device is started, so that the main channel 510 is in a negative pressure state. At this time, the drug sprayed outside the lesion can be discharged from the body through the first drug recovery hole 560 and the second drug recovery hole 570 through the main channel 510, so that the excess drug in the proximal and distal directions of the double-layer balloon structure can be discharged in time, ensuring that the drug can be recovered from different positions of the balloon catheter, thereby improving the efficiency and thoroughness of drug recovery, reducing the residue of drug in the body, and further reducing the harm of the drug to the human body.

[0053] The pressurizing handle 300 is used to inject a medium into the inner balloon 700 to increase its internal pressure. Specifically, the pressurizing handle 300 is connected to the proximal end of the three-lumen catheter 500 through the connector 400, and the pressurizing handle 300 is connected to the medium cavity 530. An inner balloon pressurizing hole 550 connected to the medium cavity 530 is provided on the tube wall of the three-lumen catheter 500, and the opening position of the inner balloon pressurizing hole 550 is located inside the inner balloon 700. The medium is injected into the medium cavity 530 through the pressurizing handle 300, transported by the medium cavity 530, and finally discharged into the inner balloon 700 through the inner balloon pressurizing hole 550. As the amount of injected medium gradually increases, the internal pressure of the inner balloon 700 will gradually increase, and the volume will also gradually increase, thereby achieving the expansion of the inner balloon 700, and then pushing the outer balloon 800 to gradually open.

[0054] like Figure 3 As shown, the main channel 510 is a cylindrical cavity with an inner diameter of 1 mm, which can pass a 0.035-inch guide wire, and the injection cavity 520 and the medium cavity 530 are arc-shaped cavities located on both sides of the main channel 510, that is, the cross-sections of the injection cavity 520 and the medium cavity 530 are arc-shaped. The above structural design, first, makes the structure of the balloon catheter more compact, which is convenient for operation and insertion into the human cavity; second, it ensures that the drug solution and the medium can be evenly and quickly transported in the three cavities to improve the treatment efficiency; third, it is convenient to determine the opening positions of the drug injection hole 540, the inner balloon pressurization hole 550, the first drug solution recovery hole 560 and the second drug solution recovery hole 570 to ensure the smooth entry and discharge of the drug solution and the medium.

[0055] like Fig.10 As shown, the three-lumen catheter 500 is a reducer tube. Specifically, the three-lumen catheter 500 is divided into a handle section 501, a reducer section 502 and a balloon section 503 from the proximal end to the distal end.

[0056] The proximal end of the handle segment 501 is connected to the medication handle 100, the main handle 200, and the pressurizing handle 300 respectively through the connector 400. The outer diameter of the handle segment 501 of the three-lumen catheter is 2.6 mm, which can provide sufficient strength and stability for easy operation.

[0057] The outer diameter of the reducing section 502 gradually decreases from the proximal end to the distal end, thereby achieving a smooth transition from the handle section 501 to the balloon section 503 and reducing damage to the inner wall of the cavity when inserting and withdrawing the balloon catheter.

[0058] The balloon segment 503 is the part where the double-layer balloon structure is located, that is, the outer balloon 800 and the inner balloon 700 are both arranged on the balloon segment 503 of the three-lumen catheter, and when the double-layer balloon structure is not opened, the outer balloon 800 and the inner balloon 700 are folded on the surface of the balloon segment 503, thereby increasing the overall outer diameter of the balloon segment 503. In this embodiment, the outer diameter of the balloon segment 503 of the three-lumen catheter is designed to be 1.8 mm to 2.0 mm. This size range ensures that the overall outer diameter of the balloon segment 503 can still be controlled within 2.6 mm while accommodating the double-layer balloon structure, so that the overall outer diameter of the balloon segment 503 will not increase significantly, thereby helping the balloon catheter to pass through the narrow cavity smoothly and facilitate insertion.

[0059] The diameters of the two ends of the outer balloon 800 are larger than the diameter of the middle part, specifically, the diameters of the two ends of the outer balloon 800 when it is in the open state are larger than the diameter of the middle part, so that the outer shape of the outer balloon 800 during the expansion process is dog-bone shaped, characterized by being large at both ends and small in the middle. This structural feature allows the two end regions of the outer balloon 800 to first contact the inner wall of the cavity and quickly form support during the process of gradually injecting the liquid medicine into the temporary drug storage cavity 1000, and can also stabilize the position of the balloon while opening the cavity. At this time, a certain gap 810 will be left between the middle region of the outer balloon 800 and the inner wall of the cavity, providing a certain space for the liquid medicine to be sprayed, that is, the gap 810 can be used as a residence space for the medicine, so that the liquid medicine can be concentrated in the treatment area. Moreover, since the two end regions are closely fitted with the inner wall of the cavity, the gap 810 is in a closed state, so that the liquid medicine entering the gap 810 will not flow out from both sides, thereby preventing the drug from leaking out. Since the drug is confined to a specific space, it can act more effectively on the treatment area, improving the utilization rate of the drug. At the same time, the drug will not diffuse to other areas of the cavity at will, thereby reducing the residue of the drug in the body and reducing the risk of potential side effects.

[0060] The difference between the maximum diameter at both ends of the outer balloon 800 and the minimum diameter in the middle of the outer balloon 800 is 3 mm to 4 mm, which helps to control the distribution of the drug in the cavity so that the drug acts more evenly on the treatment area.

[0061] The inner balloon 700 is made of a semi-compliant material, usually PA or PEBAX, and the outer balloon 800 is made of a non-compliant material, usually nylon or PEBAX.

[0062] The outer balloon 800 is provided with a plurality of rows of semi-permeable holes, and the semi-permeable holes 820 in each row are evenly opened along the longitudinal direction of the outer balloon 800, and the longitudinal direction of the outer balloon 800 refers to the extension direction of the three-lumen catheter 500. The semi-permeable holes 820 mean that when the pressure on the inner wall of the outer balloon 800 does not reach the first threshold, the semi-permeable holes 820 remain closed to prevent the drug solution from flowing out in advance, and when the pressure on the inner wall of the outer balloon 800 reaches the first threshold, the semi-permeable holes 820 rupture, and the drug solution in the drug temporary storage cavity 1000 will be ejected through the semi-permeable holes 820, enter the gap 810 and be evenly distributed in the treatment area. Among them, the first threshold can be 1atm.

[0063] The semi-permeable hole 820 is designed to open only under a specific pressure threshold. This pressure-sensitive property allows doctors to accurately control the timing and rate of release, ensuring that the drug is released at the correct time and location, thereby improving the safety of the treatment process. Furthermore, since the semi-permeable holes 820 are evenly opened along the longitudinal direction of the outer balloon 800, the drug can evenly cover a larger treatment area.

[0064] A cutting mark 830 is set between two adjacent semi-permeable holes 820 in each column. The cutting mark 830 is a cut groove opened on the surface of the outer balloon 800 between two adjacent semi-permeable holes 820 in each column. The depth of the cut groove is 0.02mm to 0.05mm. This numerical range not only ensures the strength of the balloon, but also makes it easy to rupture when a specific pressure is reached. When the pressure on the inner wall of the outer balloon 800 does not reach the second threshold, the cutting mark 830 remains in the original unruptured state, and when the pressure on the inner wall of the outer balloon 800 reaches the second threshold, the cutting mark 830 ruptures, and the remaining liquid medicine in the drug temporary storage cavity 1000 will enter the gap 810 through the gap formed after the cutting mark 830 ruptures. Among them, the second threshold can be 3atm.

[0065] When the pressure on the inner wall of the outer balloon 800 reaches the first threshold, it is possible that the semi-permeable holes 820 are not ruptured or not completely ruptured, and the semi-permeable holes 820 may be adsorbed on the inner wall of the human body cavity, so that the liquid medicine cannot be discharged in time. Therefore, in this embodiment, a cutting mark 830 is designed between two adjacent semi-permeable holes 820 in each row. When the pressure on the inner wall of the outer balloon 800 reaches the first threshold and the pressure continues to increase under the push of the inner balloon 700, when it reaches the second threshold, the outer balloon 800 will rupture along the cutting mark 830 and discharge all the liquid medicine.

[0066] The cutting mark 830 provides a backup release path for the drug solution, ensuring that the drug can be completely discharged, avoiding the problem of treatment failure and low drug utilization rate caused by the failure of the semi-permeable hole 820 to work properly. This dual pressure threshold design provides a more reliable and safe drug release mechanism. In addition, since the outer balloon 800 is ruptured along the opening direction of the cutting mark 830, it is a regular longitudinal rupture, and no balloon fragments will fall into the cavity, reducing the risk of complications. At the same time, the longitudinal rupture makes it easier to remove the endoscope from the balloon, improving the convenience of the operation.

[0067] The inner balloon 700 is a three-stage expansion balloon, that is, the inner balloon 700 is designed to expand gradually under three different prescribed pressures, each pressure corresponding to a prescribed value of the balloon diameter. When the medium is continuously injected into the inner balloon 700, the inner balloon 700 will reach the first prescribed diameter value under the first pressure, then reach the second prescribed diameter value under the second pressure, and finally reach the third prescribed diameter value under the third pressure. Through this graded expansion, the expansion process can be controlled more accurately, avoiding the damage that may be caused by excessive expansion at one time, and enabling medical personnel to better control the expansion process, thereby improving the safety of treatment.

[0068] The three-stage balloon is designed to:

[0069] When the internal pressure of the inner balloon 700 gradually increases and before reaching the first level pressure, the inner balloon 700 pushes the outer balloon 800 to gradually open until the two end areas of the outer balloon 800 fit the inner wall of the human cavity and form a support, and a certain gap 810 is left between the middle area of ​​the outer balloon 800 and the inner wall of the human cavity. In this process, the outer balloon 800 will reach the first threshold, so that the semi-permeable hole 820 is gradually opened, and then the liquid in the temporary drug storage cavity 1000 enters the gap 810 through the semi-permeable hole 820 and acts on the lesion on the inner wall of the cavity. At this time, the inner balloon 700 has not been fully opened, that is, the pressure has not reached the first level pressure.

[0070] When the internal pressure of the inner balloon 700 continues to increase and reaches the first level pressure, the volume of the drug storage cavity 1000 reaches the minimum value, that is, the outer wall of the inner balloon 700 and the inner wall of the outer balloon 800 are almost completely in contact, and the drug solution is completely discharged. At this time, the inner balloon 700 has expanded the inner wall of the human body cavity.

[0071] When the internal pressure of the inner balloon 700 continues to increase, from the first level pressure to the second level pressure, and finally to the third level pressure, the diameter of the inner balloon 700 also gradually expands to the maximum value. Since the inner balloon 700 pushes the outer balloon 800 to open further, the volume of the gap 810 gradually decreases until it reaches the minimum value. The opening action of the outer balloon 800 in this process will compress the liquid medicine on the surface of the lesion, so that the liquid medicine is further absorbed, and the use efficiency of the liquid medicine is increased. When the volume of the gap 810 reaches the minimum value, the middle area of ​​the outer wall of the outer balloon 800 is almost completely fitted with the inner wall of the human body cavity. Moreover, in the process that the internal pressure of the inner balloon 700 reaches the second level pressure from the first level pressure to the second level pressure, and finally reaches the third level pressure, the outer balloon 800 will reach the second threshold value, so that the cutting mark 830 gradually breaks, and then the remaining liquid medicine in the temporary drug storage cavity 1000 enters the gap 810 through the gap generated after the cutting mark 830 breaks, and acts on the lesion on the inner wall of the cavity.

[0072] The marking ring 600 is arranged on the three-lumen catheter 500 and is located inside the inner balloon 700. The marking ring 600 is made of platinum-iridium alloy and is used for balloon positioning, that is, the marking ring 600 can observe the balloon position under X-ray.

[0073] like Fig. 9 As shown in FIG. 1 , if the injection hole 540 is located inside the outer balloon 800 and the inner balloon 700 and the outer balloon 800 are not of equal length, the liquid medicine at both ends of the temporary drug storage cavity 1000 cannot be discharged, resulting in low utilization of the liquid medicine. Figure 8 As shown, the outer balloon 800 includes: an outer balloon body 840 and an outer balloon tube corner 850. The outer balloon body 840 is arranged on the three-lumen catheter 500 through the outer balloon tube corner 850. The length of the outer balloon body 840 is consistent with the length of the inner balloon 700, and the opening position of the injection hole 540 is located in the outer balloon tube corner 850. This design does not occupy the internal space of the outer balloon 800, and an outer balloon with the same length as the inner balloon 700 can be used, so that the liquid medicine is discharged more thoroughly, the treatment effect is guaranteed, and the utilization rate of the liquid medicine is improved. At the same time, the outer balloon tube corner 850 needs to be thickened to provide stronger support performance.

[0074] Directions:

[0075] Step 1: Use an endoscope to find the narrow part of the cavity.

[0076] Step 2: Use the marking ring 600 for positioning, and pass the catheter through the endoscope to reach the narrow position, so that the center of the double-layer balloon structure is located in the middle of the narrow position of the cavity.

[0077] Step 3: Ensure that the medication handle 100 is in a passage state, and use a syringe to inject about 2 ml of medication solution into the medication temporary storage chamber 1000 through the medication handle 100. At this time, the inner balloon 700 is in a folded state, the pressure in the outer balloon 800 is very small, and the semi-permeable hole 820 is not broken. Use a stopcock to close the medication handle 100.

[0078] Step 4: inject physiological saline into the inner balloon 700 through the pressure handle 300 to expand the inner balloon 700. As the inner balloon 700 expands, the pressure in the outer balloon 800 will gradually increase. When the pressure increases to the first threshold, the semi-permeable hole 820 ruptures, and the liquid medicine is sprayed out and sprayed onto the inner wall of the cavity. At this time, the inner balloon 700 has not been fully opened, and the pressure has not reached the first level. At the same time, because the outer balloon 800 adopts a dog bone shape, the two end areas reach the inner wall of the cavity first, playing a supporting role, and the middle area is concave to form a gap 810, providing space for liquid medicine spraying.

[0079] Step 5: Continue to increase the pressure of the inner balloon 700. When the pressure of the inner balloon 700 reaches the first level, the inner balloon 700 has expanded the inner wall of the cavity, and the liquid medicine has been completely discharged. Continue to increase the pressure inside the inner balloon 700 to reach the second level and the third level respectively, the diameter of the inner balloon 700 also gradually expands to the maximum value, and the outer balloon 800 compresses the liquid medicine on the surface of the lesion, so that the liquid medicine is further absorbed, increasing the use efficiency of the liquid medicine.

[0080] Step 6: After the pressure in the inner balloon 700 reaches the third level pressure, a negative pressure suction device can be connected to the main handle 200 to form negative pressure in the main channel 510. The medicine sprayed outside the lesion can be discharged from the body through the first medicine recovery hole 560 and the second medicine recovery hole 570, further reducing the harm of the medicine to the human body.

[0081] Step 7: After the expansion is completed, remove the negative pressure suction device and retract the balloon.

[0082] By adopting a double-layer balloon structure, when the internal pressure of the inner balloon 700 gradually increases and pushes the outer balloon 800 to gradually open, the two treatment methods of spraying and expansion are performed simultaneously, thereby improving the effectiveness of the treatment; while ensuring that the drug can act accurately on the lesion, the efficiency of drug use can also be guaranteed; it is not limited by the type of drug solution, and compared with the existing drug balloon and drug stent treatment methods, the scope of application of this application is wider, and the treatment is non-invasive. Not only does it not require the implantation of foreign objects, but it also does not require instruments to enter the human cavity multiple times. It causes less harm to the human body and can greatly reduce the patient's discomfort during treatment.

[0083] The balloon catheter of the present invention can be manufactured in various specifications and is suitable for human digestive tract, airway, bile duct and other human cavities.

[0084] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A balloon catheter for drug release in a human cavity, characterized in that: include: An outer balloon and an inner balloon located inside the outer balloon, wherein a drug temporary storage cavity is formed between the inner balloon and the outer balloon; The diameters of the two ends of the outer balloon are larger than the diameter of the middle part; The outer balloon is provided with a plurality of rows of semi-permeable holes, the semi-permeable holes in each row are opened along the longitudinal direction of the outer balloon, and a cutting mark is provided between two adjacent semi-permeable holes in each row; The inner balloon is a three-stage expansion balloon, so that: When the internal pressure of the inner balloon gradually increases and before reaching the first level pressure, the inner balloon pushes the outer balloon to gradually open until the two end areas of the outer balloon are in contact with the inner wall of the human body cavity, and a certain gap is left between the middle area of ​​the outer balloon and the inner wall of the human body cavity, and at the same time, the semi-permeable hole is opened, and the drug solution in the drug temporary storage cavity enters the gap through the semi-permeable hole; When the internal pressure of the inner balloon continues to increase and reaches the first level pressure, the volume of the drug temporary storage cavity reaches a minimum value; When the internal pressure of the inner balloon exceeds the first level pressure due to continuous increase, the outer balloon pressure will reach the second threshold in this process. At this time, if the liquid medicine in the outer balloon cannot be discharged from the micropores, the cutting marks of the outer balloon will rupture as the inner balloon expands.

2. A balloon catheter for drug release in a human cavity according to claim 1, characterized in that: Also includes: A three-lumen catheter, the outer balloon and the inner balloon are both arranged on the three-lumen catheter, a drug injection cavity is provided in the three-lumen catheter, and a drug injection hole connected to the drug injection cavity is provided on the tube wall of the three-lumen catheter; The outer balloon comprises an outer balloon body and an outer balloon tube corner. The length of the outer balloon body is consistent with the length of the inner balloon. The injection hole is located inside the outer balloon tube corner.

3. A balloon catheter for drug release in a human cavity according to claim 2, characterized in that: The three-lumen catheter is divided into a handle section, a reducing section and a balloon section from the proximal end to the distal end, and the outer balloon and the inner balloon are both arranged on the balloon section of the three-lumen catheter; the outer diameter of the handle section of the three-lumen catheter is 2.6mm, and the outer diameter of the reducing section of the three-lumen catheter gradually decreases from the proximal end to the distal end, and the outer diameter of the balloon section of the three-lumen catheter is 1.8mm~2.0mm.

4. A balloon catheter for drug release in a human cavity according to claim 3, characterized in that: The difference between the maximum diameters of the two ends of the outer balloon and the minimum diameter of the middle portion of the outer balloon is 3 mm to 4 mm.

5. A balloon catheter for drug release in a human cavity according to claim 4, characterized in that: The cutting marks are incision grooves formed on the surface of the outer balloon wall between two adjacent semi-permeable holes in each row, and the depth of the incision grooves is 0.02 mm to 0.05 mm.

6. A balloon catheter for drug release in a human cavity according to claim 5, characterized in that: A main channel is provided in the three-lumen catheter; the distal end of the three-lumen catheter passes through the outer balloon and the inner balloon, and a head end tube is provided at the distal end of the three-lumen catheter, the head end tube is connected to the main channel, and a first drug recovery hole is provided at the distal tube opening of the head end tube; a second drug recovery hole is provided on the three-lumen catheter, the second drug recovery hole is connected to the main channel, and the second drug recovery hole is provided on the side of the outer balloon close to the proximal end.

7. A balloon catheter for drug release in a human cavity according to claim 6, characterized in that: A medium cavity is provided in the three-cavity catheter, and an inner balloon pressurizing hole connected with the medium cavity is provided on the tube wall of the three-cavity catheter. The inner balloon pressurizing hole is provided inside the inner balloon.

8. The balloon catheter for drug release in a human cavity according to claim 7, characterized in that: Also includes: Two identification rings are arranged on the three-lumen catheter and are located inside the inner balloon.

9. The balloon catheter for drug release in a human cavity according to claim 8, characterized in that: Also includes: A medication handle, a main handle, a pressurizing handle and a connecting piece, wherein the medication handle, the main handle and the pressurizing handle are connected to the proximal end of the three-lumen catheter via the connecting piece, the medication handle is connected to the injection cavity, the main handle is connected to the main channel, and the pressurizing handle is connected to the medium cavity.

10. The balloon catheter for drug release in a human cavity according to claim 9, characterized in that: The main channel is a cylindrical cavity with an inner diameter of 1 mm, and the drug injection cavity and the medium cavity are arc-shaped cavities respectively located on both sides of the main channel.

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