Independently inflatable double-balloon drug delivery construct for biliary ducts

Abstract

The utility model provides a kind of independent inflatable double-balloon drug release structure for bile duct, including one pipe body has opposite two end surfaces, and a central wire channel is set through the two end surfaces;The pipe body has a first inflation hole, a dosing hole and a second inflation hole, and the dosing hole is arranged between the first inflation hole and the second inflation hole in the length direction;From one end surface, a first inflation channel, a dosing channel and a second inflation channel are extended in the pipe body, the first inflation channel is communicated with the first inflation hole, the dosing channel is communicated with the dosing hole, and the second inflation channel is communicated with the second inflation hole, and the first inflation channel, the dosing channel and the second inflation channel are not communicated with each other;A first balloon body is arranged at the position corresponding to the first inflation hole;A second balloon body is arranged at the position corresponding to the second inflation hole;A dosing space is arranged adjacent to the first balloon body and / or the second balloon body.

Description

Technical Field

[0001] This utility model relates to a drug release structure, and more particularly to a double-balloon drug release structure for bile ducts that can be independently inflated. Background Technology

[0002] Based on the location of the tumor within the bile duct, bile duct cancer is classified into upper, middle, and lower segment bile duct cancer. Upper segment bile duct cancer, also known as hilar bile duct cancer, is located above the openings of the left and right hepatic ducts to the cystic duct. It can be further divided into five types based on its location: Type I: Tumor located in the common bile duct, without invading the confluence of the left and right hepatic ducts; Type II: Tumor invading the confluence, without invading the left or right hepatic duct; Type IIIa: Tumor invading the right hepatic duct; Type IIIb: Tumor invading the left hepatic duct; Type IV: Tumor invading both the left and right hepatic ducts. Middle segment bile duct cancer is located from the opening of the cystic duct to the upper border of the duodenum, while lower segment bile duct cancer is located from the upper border of the duodenum to the duodenal papilla.

[0003] Tumors grow within the bile ducts, and treatment primarily involves intravenous or oral medications. However, these medications circulate throughout the body, potentially causing significant side effects. For instance, intravenous injection of Cisplatin can cause nausea, vomiting, tinnitus, and low blood cell counts. Intravenous injection of Oxaliplatin can lead to peripheral sensory nerve damage, resulting in abnormal nerve endings, fatigue or weakness, nausea, and vomiting. Oral administration of Capecitabine can cause edema, dermatitis, constipation, and diarrhea.

[0004] To replace intravenous or oral medications and avoid systemic drug circulation, Chinese Patent Publication No. CN118320191A, "Drug-Coated Balloon Catheter for Non-vascular Stenosis," provides a method for treating non-vascular cavities with stenosis, such as urethral stricture, benign prostatic hyperplasia (BPH) stricture, ureteral stricture, esophageal stricture, sinus tract stricture, and biliary stricture. The aforementioned patent provides a method for treating at least one of the following: benign prostatic hyperplasia (BPH), prostate cancer, asthma, and chronic obstructive pulmonary disease (COPD). The method may include, for example, delivery of anti-inflammatory and anti-proliferative drugs (e.g., rapamycin, paclitaxel, and analogues thereof) and one or more additives via a drug-coated balloon catheter.

[0005] Although the aforementioned case involved using a balloon catheter to penetrate deep into the lesion and directly applying medication placed on the surface of the balloon to the lesion, this method could replace intravenous or oral medication and reduce the chance of side effects.

[0006] However, the aforementioned case involved applying medication to the surface of a balloon to treat tumors within the bile duct. During use, a duodenoscope was inserted through the mouth, passing through the esophagus, stomach, and duodenum into the bile duct. The medication already applied to the surface of the balloon would inevitably come into contact with the duct wall during the movement, allowing the medication to remain in a non-lesion location rather than being directly applied to the lesion.

[0007] If the medication is not applied directly to the lesion, it will not be able to effectively treat the tumor. If the medication comes into contact with the vessel wall, it will be absorbed by the body and produce side effects. As a result, it is impossible to achieve 100% local treatment of the tumor and may produce side effects, which will cause pain to the patient.

[0008] In addition, when the tumor is large, balloons need to be used repeatedly, which inevitably puts a burden on the patient by repeatedly inserting the duodenoscope into the patient's body. Utility Model Content

[0009] Therefore, the purpose of this invention is to provide a dual-balloon drug release structure for bile ducts that can be inflated independently, so that the drug can be reliably applied to the tumor site and the balloon will not leave the drug on the tube wall when passing through the tube, and the duodenoscope does not need to be repeatedly inserted into the body.

[0010] This invention provides an independently inflatable double-balloon drug delivery structure for bile ducts, characterized in that it comprises:

[0011] A tube body extends along a length direction and has a central tube section. An outer surface covers the central tube section. The central tube section has two opposing end faces. A central guide channel is disposed in the central tube section and passes through the two end faces. A first inflation hole, a drug delivery hole, and a second inflation hole are disposed on the outer surface. The drug delivery hole is disposed between the first inflation hole and the second inflation hole along the length direction. A first inflation channel, a drug delivery channel, and a second inflation channel extend from one end face of the central tube section. The first inflation channel extends and connects to the first inflation hole. The drug delivery channel extends and connects to the drug delivery hole. The second inflation channel extends and connects to the second inflation hole. The first inflation channel, the drug delivery channel, and the second inflation channel are not interconnected.

[0012] A first bladder is disposed on the outer surface and corresponds to the position of the first inflation hole, and the first bladder is connected to the first inflation hole;

[0013] A second bladder is disposed on the outer surface and corresponds to the position of the second inflation hole, and the second bladder is connected to the second inflation hole;

[0014] The first capsule can be inflated through the first inflation channel and the first inflation hole, and / or the second capsule can be inflated through the second inflation channel and the second inflation hole, forming a drug delivery space at the position corresponding to the drug delivery hole, the drug delivery space being adjacent to the first capsule and / or the second capsule;

[0015] This allows the drug to flow into the drug delivery space through the drug delivery channel and the drug delivery orifice.

[0016] Furthermore, the central lead channel is located at the center of the central tube, and the first inflation channel, the drug delivery channel, and the second inflation channel are arranged around the central tube.

[0017] Furthermore, the angle between the line connecting the center of any two of the first inflation channel, the drug delivery channel, and the second inflation channel and the center of the central guide channel is 120 degrees.

[0018] Furthermore, the first cyst and the second cyst are spherical or columnar.

[0019] Furthermore, the other end of the tube is conical.

[0020] Furthermore, the tube body has four extension tube sections extending from one of its end faces, and the central guide channel, the first inflation channel, the drug delivery channel and the second inflation channel extend to the four aforementioned extension tube sections respectively.

[0021] The following effects can be achieved based on the above technical features:

[0022] 1. Using a double balloon to expand within the bile duct and define the drug delivery space at the location of the lesion can reduce the area of ​​drug distribution on the body during administration, and directly apply the drug to the lesion, which can effectively reduce the side effects on the human body when the drug takes effect.

[0023] 2. The medication can be continuously administered to the lesion through the administration port, without the need to repeatedly remove the tube and thus avoid additional burden on the patient.

[0024] 3. When the lesion area is large, it can control the dilation of only one balloon, isolate the part of the bile duct without lesions, and allow the drug to be delivered only to the bile duct with lesions, thus providing greater flexibility in use. Attached Figure Description

[0025] Figure 1 This is a three-dimensional view of the present invention.

[0026] Figure 2 This is a cross-sectional view of the first air inlet and the first bladder of the tube body in this utility model.

[0027] Figure 3 This is a cross-sectional view of the drug delivery port located in the tube body of this utility model.

[0028] Figure 4 This is a cross-sectional view of the second air inlet and the second bladder body of the present invention.

[0029] Figure 5 This is a schematic diagram illustrating the use of this invention to penetrate the bile duct and expand the second cyst.

[0030] Figure 6 This is a schematic diagram illustrating the use of this utility model to penetrate into the bile duct and expand the first and second cysts.

[0031] Figure 7 This is a schematic diagram illustrating the use of the drug delivery space formed between the first and second capsules, where the drug is delivered through the drug delivery channel and the drug delivery port.

[0032] Figure 8 This is a schematic diagram illustrating the use of a catheter fixed to the bile duct using only the second capsule.

[0033] Figure 9 This is a schematic diagram illustrating the use of a catheter fixed to the bile duct using only the second capsule.

[0034] Figure 10 This is a partial view of another embodiment of the present invention.

[0035] Figure 11 The first and second capsules of this utility model are spherical in appearance.

[0036] Explanation of reference numerals in the attached drawings: 1, 1A - tube body; 11 - central tube section; 12 - outer surface; 121 - first inflation port; 122 - drug delivery port; 123 - second inflation port; 13 - central lead wire channel; 14 - first inflation channel; 15 - drug delivery channel; 16 - second inflation channel; 17A - extension tube section; 2, 2A - first capsule; 3, 3A - second capsule; D - bile duct; E - lesion. Detailed Implementation

[0037] Based on the above technical features, the main functions of the independently inflatable double-balloon drug release structure for bile ducts of this invention will be clearly demonstrated in the following embodiments.

[0038] Please see Figure 1 As shown, this utility model provides a double-balloon drug release structure for bile ducts that can be independently inflated, comprising a tube body 1, a first balloon body 2 and a second balloon body 3.

[0039] Please see Figure 2 , Figure 3 and Figure 4As shown, the tube body 1 extends along a length direction and has a central tube portion 11, and an outer surface 12 covers the central tube portion 11. The central tube portion 11 has two opposing end faces, and a central guide channel 13 is disposed in the central tube portion 11 and passes through the two end faces. A first inflation port 121, a drug delivery port 122, and a second inflation port 123 are provided on the outer surface 12. The drug delivery port 122 is disposed between the first inflation port 121 and the second inflation port 123 along the length direction. A first inflation channel 14, a drug delivery channel 15, and a second inflation channel 16 extend from one of the end faces of the central tube portion 11. The first inflation channel 14 extends and connects to the first inflation port 121, the drug delivery channel 15 extends and connects to the drug delivery port 122, and the second inflation channel 16 extends and connects to the second inflation port 123. The first inflation channel 14, the drug delivery channel 15, and the second inflation channel 16 are not interconnected. Specifically, the cross-section of the central tube 11 is circular with a central position, and the central guide channel 13 is located at the central position. The first inflation channel 14, the drug delivery channel 15, and the second inflation channel 16 are arranged around the central tube 11, and the angle between the line connecting the center of any two of the first inflation channel 14, the drug delivery channel 15, and the second inflation channel 16 and the center of the central guide channel 13 is 120 degrees, so that the first inflation channel 14, the drug delivery channel 15, and the second inflation channel are distributed in an equidistant array around the central guide channel 13. The cross-section of the central guide channel 13, the first inflation channel 14, the drug delivery channel 15, and the second inflation channel 16 is circular, and the other end face of the tube 1 is conical.

[0040] The first bladder 2 is disposed on the outer surface 12 and corresponds to the position of the first inflation hole 121, and the first bladder 2 is connected to the first inflation hole 121; the second bladder 3 is disposed on the outer surface 12 and corresponds to the position of the second inflation hole 123, and the second bladder 3 is connected to the second inflation hole 123; specifically, the first bladder 2 and the second bladder 3 are columnar.

[0041] Please see Figure 2 , Figure 4 , Figure 5 , Figure 6 and Figure 7As shown, when using this invention, the tube 1 is inserted through the central guide channel 13 into the guide wire that has already been inserted into the human body. The tube 1 is then moved along the guide wire, and the portion of the guide wire containing the first capsule 2 and the second capsule 3 is moved to the lesion E position within the bile duct D. Upon reaching the lesion E position within the bile duct D, the second capsule 3 is inflated through the second inflation channel 16 and the second inflation port 123. This causes the second capsule 3, which has already entered the bile duct D, to expand and press against the bile duct D, thereby slightly fixing the tube 1 in place. Within the bile duct D, the first capsule 2 is inflated through the first inflation channel 14 and the first inflation port 121, causing the first capsule 2 to expand and press against the bile duct D, thus forming a drug delivery space at the position corresponding to the drug delivery port 122. The lesion E located within the bile duct D is located within this drug delivery space, which is adjacent to the first capsule 2 and the second capsule 3. Finally, the drug is delivered through the drug delivery channel 15 and the drug delivery port 122 into the drug delivery space, allowing the drug to be directly applied to the lesion E located within the bile duct D.

[0042] Please see Figure 1 , Figure 8 and Figure 9 As shown, when the lesion E in bile duct D has spread and distributed in the common bile duct and the confluence between the common bile duct and the right or left hepatic duct, or spread from the common bile duct to the right or left hepatic duct, the location and spread range of the lesion E are relatively large, and the range may be larger than the space formed between the first capsule 2 and the second capsule 3 of this invention. Therefore, in another usage of this invention, only the first capsule 2 can be expanded without expanding the second capsule 3, so that the first capsule 2 is against the common hepatic duct in bile duct D. After expansion is completed, the medicine is directly sprayed into the lesion E through the drug delivery channel 15 and the drug delivery hole 122. The medicine will not overflow into the middle or lower part of bile duct D. The medicine is blocked by the first capsule 2 and will only remain in the upper part of bile duct D. The use of this invention to treat the lesion E in bile duct D is highly flexible, and the usage method can be adjusted according to the spread range of the lesion E.

[0043] Please see Figure 10 As shown, another embodiment of the present invention includes four extension tube sections 17A with extending branches from one end face of a tube body 1A. The central guide channel 13, the first inflation channel 14, the drug delivery channel 15, and the second inflation channel 16 extend to the four aforementioned extension tube sections 17A respectively. By means of the four aforementioned extension tube sections 17A, it is convenient to mark on the aforementioned extension tube sections 17A whether they are connected to any one of the central guide channel 13, the first inflation channel 14, the drug delivery channel 15, and the second inflation channel 16, making the operation more convenient.

[0044] Please see Figure 11As shown, in another embodiment of the present invention, the first capsule 2A and the second capsule 3A may also be spherical.

[0045] Based on the above description of the embodiments, it should be fully understood that the operation, use and effects of this utility model are as follows. The above embodiments are only preferred embodiments of this utility model and should not be used to limit the scope of implementation of this utility model. That is, any simple equivalent changes and modifications made based on the content of this utility model specification are within the scope of this utility model.

Claims

1. A dual-balloon drug delivery system for bile ducts that can be independently inflated, characterized in that, include: A tube body extends along a length direction and has a central tube section. An outer surface covers the central tube section. The central tube section has two opposing end faces. A central guide channel is disposed in the central tube section and passes through the two end faces. A first inflation hole, a drug delivery hole, and a second inflation hole are disposed on the outer surface. The drug delivery hole is disposed between the first inflation hole and the second inflation hole along the length direction. A first inflation channel, a drug delivery channel, and a second inflation channel extend from one end face of the central tube section. The first inflation channel extends and connects to the first inflation hole. The drug delivery channel extends and connects to the drug delivery hole. The second inflation channel extends and connects to the second inflation hole. The first inflation channel, the drug delivery channel, and the second inflation channel are not interconnected. A first bladder is disposed on the outer surface and corresponds to the position of the first inflation hole, and the first bladder is connected to the first inflation hole; A second bladder is disposed on the outer surface and corresponds to the position of the second inflation hole, and the second bladder is connected to the second inflation hole; The first capsule can be inflated through the first inflation channel and the first inflation hole, and / or the second capsule can be inflated through the second inflation channel and the second inflation hole, forming a drug delivery space at the position corresponding to the drug delivery hole, the drug delivery space being adjacent to the first capsule and / or the second capsule; This allows the drug to flow into the drug delivery space through the drug delivery channel and the drug delivery orifice.

2. The independently inflatable double-balloon drug delivery structure for bile ducts as described in claim 1, characterized in that, The central lead channel is located at the center of the central tube, and the first inflation channel, the drug delivery channel, and the second inflation channel are arranged around the central tube.

3. The independently inflatable double-balloon drug delivery structure for bile ducts as described in claim 2, characterized in that, The angle between the line connecting the center of any two of the first inflation channel, the drug delivery channel, and the second inflation channel to the center of the central guide channel is 120 degrees.

4. The independently inflatable double-balloon drug delivery structure for bile ducts as described in claim 1, characterized in that, The first and second cysts are spherical or columnar.

5. The independently inflatable double-balloon drug delivery structure for bile ducts as described in claim 1, characterized in that, The other end of the tube is conical.

6. The independently inflatable double-balloon drug delivery structure for bile ducts as described in claim 1, characterized in that, The tube body has four extension tube sections extending from one of its end faces, and the central lead channel, the first inflation channel, the drug delivery channel and the second inflation channel extend to the four aforementioned extension tube sections respectively.

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