Balloon catheter applied to endoscopic surgery and capable of being quickly disassembled in vivo

Abstract

A balloon catheter applied to endoscopic surgery and capable of being quickly detached in vivo mainly comprises two independent units, namely an anchoring balloon and a pushing tube, and the two independent units can be quickly combined and detached in vivo. The anchoring balloon has the advantages that in an endoscopic surgery or an interventional surgery, the anchoring balloon and the pushing pipe can be freely combined or detached, an endoscopic channel is prevented from being occupied, the efficiency and convenience of the endoscopic surgery or the interventional surgery are greatly improved, and the anchoring balloon is easy to operate, safe, reliable and worthy of clinical application and popularization.

Description

Technical Field

[0001] The present application relates to a balloon catheter used in endoscopic surgery and capable of being quickly disassembled in vivo, which is a disposable sterile medical device used in hospitals. Background Art

[0002] Endoscopic surgery refers to surgery to remove lesions, stop bleeding, drain or reconstruct channels under direct endoscope vision. According to subject classification, the clinical applications of endoscopic surgery include digestive endoscopy, thoracoscopy, laparoscopy, respiratory endoscopy, cystoscopy, pyeloscopy, hysteroscopy, arthroscopy, ventriculoscopy, nasopharyngeal endoscopy, angioscope and cardioscopy. Endoscopic surgery has the advantages of simplicity, efficiency, safety, little damage to patients, low mortality and short recovery period. In recent years, its clinical application scope has been continuously expanded.

[0003] Balloon catheters are commonly used medical devices in endoscopic surgery. Their clinical uses include but are not limited to dilation of narrow areas, cavitary blockage, bleeding point blockage, or expansion of the local surgical field. During endoscopic surgery, due to the limitations of the external dimensions of the endoscope, the endoscope usually has only one instrument channel that does not exceed 2.6 mm. After the balloon catheter enters the human body, the instrument channel of the endoscope is occupied and no other operations can be performed, affecting the progress of the operation. In particular, when multiple balloons are required for blocking or hemostasis, the operation is very inconvenient. The shortcomings of existing balloon catheters have become a bottleneck and pain point in endoscopic surgery, and new technical solutions are urgently needed. Summary of the invention

[0004] In order to solve the problem that the existing balloon catheter occupies the endoscopic instrument channel after being anchored in the human body, the present application proposes a balloon catheter used in endoscopic surgery that can be quickly disassembled in the body, including two independent units: an anchoring balloon and a push tube, and the two independent units can be quickly combined and disassembled in the body. Among them, the anchoring balloon of the first unit includes an expansion balloon, a balloon support tube, and an elastic sealing body, and the push tube of the second unit is mainly composed of a micro puncture needle, a needle protection cap, a capillary catheter, an infusion interface, and a sealing cover.

[0005] The expansion balloon of the anchoring balloon is made of medical high-elasticity and high-reducibility polymer materials, including nylon, polyurethane, natural latex, silicone and polymer composite materials. According to the different clinical application sites and intended purposes, the expansion balloon has a variety of specifications and models. The length of the expansion balloon covers the range of 10mm-200mm, and the outer diameter of the expansion balloon should cover the range of 3mm-80mm (calculated as the maximum value after expansion). For example, the expansion balloon used for bronchial bleeding plugging uses a length of about 10mm and an outer diameter of about 5mm (diameter after expansion); and when used to plug gas leakage in the rectum and expand the surgical field, the length of the expansion balloon used is 40mm-60mm, and the outer diameter of the expansion balloon is 60mm-80mm (diameter after expansion).

[0006] The balloon support tube is arranged inside the expansion balloon, and the two ends of the expansion balloon are tightly bonded to the outer periphery of the balloon support tube. The balloon support tube of the anchored balloon is a tube with an injection channel inside. The head of the balloon support tube is a blocked dead space, 1-2 guide holes are arranged in the middle of the balloon support tube, and a liquid inlet is arranged at the tail of the balloon support tube. The function of the balloon support tube is to serve as a channel for injecting liquid into the expansion balloon. At the same time, it plays a supporting role when the expansion balloon is injected and expanded to prevent the expansion balloon from twisting or irregular deformation. The balloon support tube is made of polymer materials, such as nylon, polyurethane, polyvinyl chloride, and polypropylene materials, which are extruded and molded. The outer diameter of the balloon support tube is 1.5mm-2mm, and the length is defined according to the corresponding expansion balloon length. Usually, the balloon support tube is 8mm-15mm longer than the expansion balloon.

[0007] The elastic sealing body of the anchoring balloon is an elastomer that can quickly restore the seal after the puncture needle penetrates, and the elastic sealing body is sealed with the liquid inlet at the tail of the balloon support tube. The sealed combination method includes medical glue bonding and high-frequency heat sealing. The elastic sealing body is made of elastic materials including latex, silicone rubber or nylon. In one embodiment, for example, the outer diameter of the elastic sealing body is 1mm-2.3mm, and the thickness is 2mm-6mm. A puncture point is provided at the center point of the elastic sealing body. In order to facilitate identification by medical staff, the puncture point is provided with a visible mark or graphic symbol, and the thickness of the puncture point is 0.2mm-1.5mm. Preferably, the specific size of the elastic sealing body is an outer diameter of 2.0mm-2.2mm, and a thickness of 0.8mm-1.0mm at the puncture point.

[0008] Furthermore, in order to better identify the progress or placement of the anchoring balloon in the body, a developing marker is also provided on the anchoring balloon, and the developing marker is provided at one of the expansion balloon, the balloon support tube, and the elastic sealing body. The developing marker includes but is not limited to a barium sulfate wire, a platinum-iridium alloy wire, and a fluorescent dye (such as IRDye 800CW).

[0009] The micro-puncture needle of the push tube is a micro-metal needle with an injection channel in the middle, and the micro-puncture needle is tightly combined with the head of the capillary catheter. The micro-puncture needle is made of stainless steel or titanium alloy. According to the size of the anchoring balloon, the size of the micro-puncture needle is divided into a variety of specifications and models. For example, the overall length of the micro-puncture needle is divided into a variety of specifications of 5mm-15mm, the outer diameter is divided into a variety of specifications of 0.3mm-1.2mm, and the inner diameter is divided into a variety of specifications of 0.15mm-0.9mm. Preferably, the size of the micro-puncture needle is 6mm-8mm long, the outer diameter of the micro-puncture needle is 0.6mm-0.9mm, and the inner diameter is 0.3mm-0.6mm.

[0010] The needle protection cap is made of medical polyvinyl chloride or polypropylene plastic and is in the shape of a cone cap, matching the shape of the micro-puncture needle; the needle protection cap is arranged on the periphery of the micro-puncture needle.

[0011] The capillary catheter of the push tube is a slender tube with an injection channel inside, which is required to be smooth, elastic and have a certain rigidity. The head of the capillary catheter is sealed with a micro-puncture needle, and the tail of the capillary catheter is combined with an infusion interface. The function of the capillary catheter is, on the one hand, to push the anchoring balloon into the target part of the human body through the endoscopic channel, and on the other hand, to infuse liquid into the expansion balloon through the micro-puncture needle. The capillary catheter is extruded and molded with medical nylon, polyurethane, polyvinyl chloride and other polymer materials. According to different clinical application scenarios and target sites, the capillary catheter is divided into a variety of specifications and models. For example, the outer diameter of the capillary catheter is divided into a variety of specifications of 1.0mm-2.0mm, and the length of the capillary catheter is divided into a variety of specifications of 1000mm-1800mm.

[0012] The infusion interface of the push tube is sealed and combined at the tail of the capillary catheter, and a matching sealing cover is provided at the opening of the infusion interface. The shapes of the infusion interface and the sealing cover are not limited, and the infusion interface includes a tapered joint and a Luer joint. The opening of the head of the infusion interface matches the size of the sealing cover and can be sealed and combined, the tail size of the infusion interface matches the capillary catheter and can be sealed and combined, and the infusion interface and the sealing cover are injection molded by medical polymer materials, for example, medical nylon, polyurethane, polyvinyl chloride, etc.

[0013] The clinical uses of this application include but are not limited to dilation of stenosis, cavitary blockage, identification of responsible bronchus, blockage of bleeding points or expansion of local surgical field. Furthermore, in view of the innovative point that the anchoring balloon and the push tube can be quickly separated in vivo, the technical solution of this application is applicable to interventional surgery in addition to endoscopic surgery.

[0014] The technical feature of the present application is that the anchoring balloon and the push tube are two relatively independent units, and the anchoring balloon can be quickly combined with the push tube and connected as a whole. The specific combination method of the anchoring balloon and the push tube is: the micro-puncture needle pierces the elastic sealing body, so that the injection channel of the micro-puncture needle is connected with the injection channel of the balloon support tube, and the anchoring balloon and the push tube can smoothly enter the instrument channel of the endoscope after being combined, and pushed to the patient's target site. After reaching the target site, the anchoring balloon and the push tube can also be quickly separated in the patient's body. The anchoring balloon and the push tube are separated in the patient's body as follows: after the anchoring balloon is delivered to the patient's target site through the instrument channel of the endoscope, a medical pusher is used to inject liquid into the infusion interface to expand the anchoring balloon and fix it at the target site, and the push tube exposed outside the instrument channel is gently pulled to pull the micro-puncture needle out of the elastic sealing body, and the elastic sealing body automatically closes the puncture port to prevent liquid leakage, so that the expansion balloon maintains its original expansion state and is fixed at the target site, and the push tube is withdrawn from the endoscopic instrument channel as a whole, so that the endoscopic instrument channel can perform other medical operations. The beneficial effect of the present application is that in endoscopic surgery or interventional surgery, the anchoring balloon can be freely combined or separated with the push tube to avoid occupying the endoscopic channel, which greatly improves the efficiency and convenience of endoscopic surgery or interventional surgery, is simple to operate, safe and reliable, and is worthy of clinical promotion and use. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present application.

[0016] Figure 2 This is a schematic diagram of the structure of an anchoring balloon according to an embodiment of the present application.

[0017] Figure 3 This is a schematic diagram of the structure of an elastic sealing body according to an embodiment of the present application.

[0018] As shown in the figure: anchoring balloon 10, push tube 20, expansion balloon 101, balloon support tube 102, elastic sealing body 103, diversion hole 104, puncture point 105, micro puncture needle 201, capillary catheter 202, infusion interface 203, sealing cover 204 DETAILED DESCRIPTION

[0019] The present application is described in detail below with reference to the accompanying drawings and embodiments.

[0020] Example 1: A balloon catheter used for bronchial occlusion and hemostasis

[0021] (I) Preparation of anchoring balloon 10

[0022] 1. Prepare a dilatation balloon 101 with a length of 30 mm and a diameter of 30 mm (calculation of maximum expansion value)

[0023] (1) Prepare a plastic extrusion mold for the expansion balloon 101 tube embryo. The expansion balloon 101 tube embryo has an outer diameter of 8 mm and an inner diameter of 3 mm. Select nylon 12 material, use precision extrusion equipment to extrude and mold, and cut into 20 mm long tubes as the expansion balloon 101 tube embryo for standby use.

[0024] (2) Prepare a blow molding mold for the expansion balloon 101 tube embryo, and perform secondary molding of the expansion balloon 101 tube embryo under low temperature and low pressure conditions. Specifically, place the expansion balloon tube embryo into the blow molding mold, introduce nitrogen, maintain the low pressure at 2.6MPa, and gradually increase the mold temperature to 110°C. The stretching speed of the clamps at both ends is 70mm / s, and the stretching distance is 50mm to produce a thinner cone and neck wall thickness. Then, heat and maintain pressure to complete the crystallization orientation of the molded balloon. Cool and demold, take out the expansion balloon 101, cut off the excess tube embryo for pulling at both ends, the overall length of the balloon is 30mm, the neck length of both ends of the balloon is 8mm, and the inner diameter of the neck is 2.1mm for standby.

[0025] 2. Preparation of balloon support tube 102

[0026] The extrusion die for preparing the balloon support tube 102 is made of nylon 6, and the outer diameter and inner diameter of the balloon support tube 102 are 2.0 mm and 1.0 mm, respectively. The balloon support tube 102 is processed by high-precision plastic extrusion equipment, and after cooling and shaping, it is cut into balloon support tubes 102 with a length of 70 mm.

[0027] Two 1.0 mm flow guide holes 104 are formed on the outer circumference of the balloon support tube 102 using a tube punching device.

[0028] The tube head hot-melt sealing processing equipment is used to hot-melt the A end of the balloon support tube 102 into an R angle, and the injection channel of the balloon support tube 102 is completely closed. The B end of the balloon support tube 102 maintains its original shape for standby use.

[0029] 3. Preparation of elastic sealing body 103

[0030] like Figure 3 As shown, a latex processing mold is prepared, and natural latex is used to prepare an elastic sealing body 103. The elastic sealing body 103 has an outer diameter of 2.2 mm, an inner diameter of 2.0 mm, and a height of 6 mm. The puncture point 105 is circular, 1.0 mm thick, and 1.2 mm in diameter.

[0031] 4. Use medical glue to seal the elastic sealing body 103 with the B end of the balloon support tube 102 in an internal connection manner. Insert the expansion balloon 101 prepared in step 1 from the A end of the balloon support tube 102, and seal the expansion balloon 101 on the outer periphery of the balloon support tube 102 using a high-frequency heat-sealing device.

[0032] 5. Check the tightness of the combined or bonded parts and put them into storage only if they meet the requirements.

[0033] (II) Preparation of the push tube 20

[0034] 1. Prepare the extrusion die of the capillary tube 202. The material is nylon 6. The outer diameter of the balloon support tube 102 is 2.2 mm and the inner diameter is 1.6 mm. Use high-precision plastic extrusion equipment to process. After cooling and shaping, cut into capillary tubes 202 with a length of 1600 mm for standby use.

[0035] 2. Make an injection mold for the infusion interface 203 and the sealing cover 204.

[0036] The infusion interface is a one-piece design, and the infusion interface is trumpet-shaped. The trumpet opening of the infusion interface 203 is tightly matched with the sealing cover 204, and the inner diameter is 6mm. The bottom of the infusion interface 203 is bonded to the capillary tube 202, and the inner diameter is 2.4mm-2.1mm. The injection molding equipment is used and the traditional injection molding process is used for preparation.

[0037] 3. The micro-puncture needle 201 is processed by conventional infusion needle technology. The specific dimensions are: the overall length of the micro-puncture needle 201 is 7 mm, wherein the base of the micro-puncture needle 201 is 5 mm long and has an outer diameter of 1.6 mm. The outer diameter of the needle is 1.2 mm, the length is 2 mm, and the inner diameter is 0.8 mm.

[0038] 4. Heat the A end of the capillary tube 202 at low temperature until it is soft, and insert the base of the micro-puncture needle 201 into the inner cavity of the capillary tube 202. Use medical glue to bond the B end of the capillary tube 202 to the bottom of the infusion interface 203.

[0039] 5. Check the tightness of the combined or bonded parts and put them into storage only if they meet the requirements.

[0040] Example 2: Clinical application of the present application in bronchial occlusion (SBO)

[0041] Refractory pneumothorax is a common clinical problem. Selective bronchial occlusion (SBO) is a new bronchoscopic interventional technology for the treatment of refractory pneumothorax that has been developed and matured in the past two decades. The use of the product prepared in Example 1 of the present application for SBO is a new clinical choice and is particularly suitable for clinical scenarios with multiple occlusion points.

[0042] 1. Matching endoscope: Olympus bronchoscope, the working channel diameter is required to be above 2.5 mm, so as to facilitate the detection of the passage of the balloon catheter prepared in Example 1. The balloon catheter prepared in Example 1 is quickly assembled by piercing the puncture point of the elastic sealing body 103 with a micro puncture needle 201.

[0043] 2. Searching for responsible drainage bronchus (balloon method): The product prepared in Example 1 of the present application is placed in the instrument channel of the bronchoscope to search for the responsible drainage bronchus, which refers to the bronchus leading to the lobe or segment of the lung to which the pleural fistula belongs. The basic principle of balloon exploration is: under the direct vision of the bronchoscope, the anchoring balloon 10 is sent into the bronchus through the instrument channel of the bronchoscope, and 5ml-10ml of sterile saline is injected into the infusion interface 203 of the push tube 20 to expand the anchoring balloon 10. The expanded anchoring balloon 10 fills each bronchi in turn, blocking the airflow of the responsible drainage bronchus, thereby stopping the leakage of the pleural fistula and screening and identifying the responsible drainage bronchus.

[0044] 3. After finding the responsible drainage bronchus, temporarily fix the anchoring balloon 10 in the responsible drainage bronchus to stop air leakage from the pleural fistula.

[0045] 4. After the anchoring balloon 10 is fixed to the pleural fistula, slowly pull the rear end of the push tube 20 exposed outside the bronchoscope instrument channel, pull out the micro puncture needle 201, separate the anchoring balloon 10 from the push tube 20, push the push tube 20 out of the instrument channel, and remove the bronchoscope from the human body.

[0046] 5. When more than two responsible drainage bronchi need to be blocked, repeat the above steps. When more than two responsible drainage bronchi need to be blocked, the advantage of this application that it does not occupy the instrument channel is more significant.

[0047] 6. Removal of anchoring balloon 10: After SBO is completed, the bronchoscope is inserted into the responsible drainage bronchus again. After the anchoring balloon 10 is found, the foreign body forceps are inserted into the instrument channel and the dilation balloon 101 is scratched with the foreign body forceps to leak the liquid in the dilation balloon 101. The anchoring balloon 10 is clamped with the foreign body forceps and removed from the body together with the bronchoscope.

[0048] The above drawings and embodiments are only used to illustrate the technical solution of the present application and are not intended to limit it. Although the present application is described in detail with reference to the preferred embodiments, a person skilled in the art should understand that the technical solution of the present application can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present application, which should be included in the scope of the claims of the present application. It does not constitute any limitation on the scope of protection of the present application.

Claims

1. A balloon catheter used in endoscopic surgery and capable of being quickly disassembled in vivo, comprising two independent units, an anchoring balloon (10) and a push tube (20), wherein the two independent units can be quickly combined and disassembled in vivo; wherein: The anchoring balloon (10) of the first unit comprises an expansion balloon (101), a balloon support tube (102), and an elastic sealing body (103), and the pushing tube (20) of the second unit mainly comprises a micro-puncture needle (201), a needle protection cap, a capillary catheter (202), an infusion interface (203), and a sealing cover (204); the characteristics are: the balloon support tube (102) is arranged inside the expansion balloon (101), and the two ends of the expansion balloon (101) are sealed and bonded to the outer periphery of the balloon support tube (102); the balloon support tube (102) of the anchoring balloon (10) is a tube having an injection channel inside The head of the balloon support tube (102) is a blocked dead space, the middle of the balloon support tube (102) is provided with 1-2 guide holes (104), and the tail of the balloon support tube (102) is provided with a liquid inlet; the elastic sealing body (103) of the anchoring balloon (10) is an elastic body that can quickly restore the seal after the puncture needle penetrates, and the elastic sealing body (103) is tightly combined with the liquid inlet at the tail of the balloon support tube (102); the micro puncture needle (201) of the push tube (20) is a micro metal needle with an injection channel in the middle, and the micro puncture needle (201) is tightly combined with the head of the capillary catheter (202).

2. The balloon catheter that can be quickly disassembled in vivo for use in endoscopic surgery according to claim 1, characterized in that: The expansion balloon (101) has a variety of specifications and models according to different clinical application sites and intended purposes. The length of the expansion balloon (101) ranges from 10 mm to 200 mm, and the outer diameter of the expansion balloon (101) should range from 3 mm to 80 mm.

3. The balloon catheter capable of being quickly disassembled in vivo for use in endoscopic surgery according to claim 1, characterized in that: The elastic sealing body (103) has an outer diameter of 1 mm to 2.3 mm and a thickness of 2 mm to 6 mm. A puncture point (105) is provided at the center of the elastic sealing body (103). To facilitate identification by medical personnel, the puncture point (105) is provided with a visible mark. The thickness of the puncture point (105) is 0.2 mm to 1.5 mm.

4. The balloon catheter capable of being quickly disassembled in vivo for use in endoscopic surgery according to claim 1, characterized in that: The anchoring balloon (10) is also provided with a developing marker, which is arranged at one of the expansion balloon (101), the balloon support tube (102), and the elastic sealing body (103).

5. The balloon catheter for endoscopic surgery according to claim 1, which can be quickly disassembled in vivo, is characterized by: The overall length of the puncture needle (201) is divided into multiple specifications of 5 mm to 15 mm, the outer diameter is divided into multiple specifications of 0.3 mm to 1.2 mm, and the inner diameter is divided into multiple specifications of 0.15 mm to 0.9 mm.

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