Expansion plugging balloon catheter, manufacturing method and using method thereof

Abstract

The invention relates to an expanding and plugging balloon catheter, a manufacturing method and a using method thereof, the expanding and plugging balloon catheter comprises a three-cavity tube and a first balloon, and the first balloon is made of a non-compliant material; the second balloon is made of compliant materials, one end of the second balloon is in sealed connection with the surface of the first balloon, and the other end of the second balloon is in sealed connection with the surface of the catheter body. A manufacturing method of the dilatation and plugging balloon catheter comprises the following steps: mounting the first balloon on the three-cavity tube; the positions, needing the second balloon, of the first balloon and the catheter body are lined with sleeves, liquid made of polyurethane materials is soaked on the surfaces of the first balloon and the catheter body through a soaking method, then the opening of the membrane and the catheter body of the three-cavity catheter are sealed in a dispensing mode or a polyurethane material dip-coating mode, and installation of the second balloon is completed. Different expansion modes can be selected according to the condition of a diseased region of a patient, a doctor is helped to better treat the diseased region, the operation time of the doctor is saved, and the patient is benefited.

Description

Technical Field

[0001] The present invention relates to the field of medical equipment, and in particular to an expansion and occlusion balloon catheter, a manufacturing method and a use method thereof. Background Art

[0002] The rapid economic growth has brought about changes in lifestyle, bad living habits and eating habits, etc., which have led to infections, scars, cancer, blockage or narrowing of the body's natural cavities, scarring, cancer, and atherosclerosis. Digestive tract stenosis has led to symptoms such as difficulty eating and pain, urinary tract stenosis has led to symptoms such as difficulty urinating, and cardiovascular stenosis has led to insufficient blood supply to the heart, causing chest tightness, shortness of breath, angina pectoris and other symptoms. These diseases have seriously affected the life and health of patients. For stenosis, if drugs are difficult to relieve, balloon dilatation is often required. This surgery is an emerging interventional treatment method in recent years. It has the advantages of less trauma, quick recovery, and short hospitalization time, and has a good therapeutic effect in clinical use.

[0003] The schematic diagram of the balloon dilatation catheter currently on the market is shown in Figure 1 The invention is composed of a front soft head 12, a balloon 11, a developing marker, a catheter 10, and a handle. The balloon 10 is made of a non-compliant material (such as PA / Pebax). The balloon catheter of this structure can only dilate the stenosis. When the blood flow rate or airflow needs to be controlled during the operation, other instruments need to be inserted for blocking. This operation is complicated and takes a long time. Summary of the invention

[0004] The technical problem to be solved by the present invention is: to overcome the shortcomings of the existing technology, to provide an expansion and blocking balloon catheter, a manufacturing method and a use method thereof, to solve the technical problem that the balloon catheters currently on the market can only play the role of expanding stenosis, and when it is necessary to control the blood flow rate or the airflow during the operation, other instruments need to be inserted for blocking, and this operation is complicated and the operation time is long.

[0005] The technical solution adopted by the present invention to solve its technical problem is:

[0006] First aspect:

[0007] Provided is a dilatation and occlusion balloon catheter, comprising

[0008] A three-lumen tube comprising a first expansion lumen, a second expansion lumen, and a guidewire lumen;

[0009] A first balloon, which is made of a non-compliant material, with both ends of the first balloon sealedly connected to the surface of the tube body, and the first balloon is in communication with the first expansion cavity;

[0010] The second balloon is made of compliant material, one end of the second balloon is sealed to the surface of the first balloon, and the other end is sealed to the surface of the tube body, part of the first balloon surface and part of the tube body surface are located inside the second balloon, and the second balloon is connected to the second expansion cavity.

[0011] Furthermore, the second balloon is made of a polyurethane membrane.

[0012] Furthermore, the second balloon and the tube body are sealed by dispensing or dipping with polyurethane material.

[0013] Second aspect:

[0014] A method for manufacturing the above-mentioned dilatation and occlusion balloon catheter is provided, comprising:

[0015] Step S01, selecting a three-lumen tube and installing a first balloon on the three-lumen tube;

[0016] Step S02, a sleeve is lined on the first balloon and the tube body where the second balloon is needed, and a liquid of polyurethane material is used to impregnate the surface of the first balloon and the catheter through an immersion method. After the immersion is completed, the lining sleeve is pulled out, and the polyurethane film is covered on the first balloon. Then, the opening of the film is sealed with the tube body of the three-lumen tube by dispensing or dipping with polyurethane material, and the second balloon is installed.

[0017] The third aspect:

[0018] Provided is a method for using the above-mentioned dilatation and occlusion balloon catheter, wherein a guide wire is sent to the distal end of the stenosis and left there, and then the guide wire is inserted into the guide wire cavity of the balloon catheter, and the balloon catheter is placed at the lesion site through the guide wire. If the lesion site is stenosis, a pressure pump is used to inject liquid into the first dilatation cavity, the first balloon is slowly expanded, and the stenosis is slowly torn open. After the working pressure is reached, the pressurization is stopped, and the pressure is maintained. After the expansion reaches an ideal effect, the pressure of the first balloon is relieved and the balloon catheter is taken out.

[0019] If bleeding occurs at the lesion site during the operation, the second balloon will be placed at the bleeding site, and liquid will be injected into the second expansion cavity. The second balloon will slowly expand to block the bleeding site to control bleeding and prevent blood from flowing into a specific area, providing a clear field of view and working space for surgical operations.

[0020] The beneficial effects of the present invention are:

[0021] The expansion and blocking balloon catheter of the present invention combines a non-compliant balloon and a compliant balloon into a balloon catheter structure, which has the functions of expansion and blocking. A balloon catheter can achieve multiple functions. Doctors can choose different expansion methods according to the condition of the patient's lesion site, which helps doctors to better treat the lesion site, saves doctors' surgical operation time, and benefits patients. At the same time, one device can achieve the functions of two devices, which can save manufacturing costs. A compliant balloon is formed by impregnating a layer of polyurethane film on the non-compliant balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The present invention is further described below in conjunction with the accompanying drawings.

[0023] Figure 1 It is the balloon dilatation catheter structure currently on the market;

[0024] Figure 2 Schematic diagram of the dilatation and occlusion balloon catheter of the present invention (first balloon dilation state);

[0025] Figure 3 Schematic diagram of the dilatation and occlusion balloon catheter of the present invention (two balloon dilation states);

[0026] Figure 4 It is a stereoscopic diagram of the dilatation and occlusion balloon catheter of the present invention;

[0027] Among them, 1. front end soft head, 2. first balloon, 3. development mark, 4. second balloon, 5. three-lumen tube, 6. connector, 7. handle. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, not 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.

[0029] The present application provides an expansion and occlusion balloon catheter, which is described in detail below. It should be noted that the description order of the following embodiments does not limit the preferred order of the embodiments of the present application. In the following embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, please refer to the relevant description of other embodiments.

[0030] In order to solve the technical problem that the balloon catheter in the prior art can only play the role of dilating and blocking the stenosis, when the blood flow rate or air flow needs to be controlled during the operation, other instruments need to be inserted for blocking, and this operation is complicated and the operation time is long, an embodiment of the present application provides a dilating and blocking balloon catheter. The following is a detailed description.

[0031] like Figure 2 , Figure 3 as well as Figure 4 As shown, a dilatation and occlusion balloon catheter comprises

[0032] A three-lumen tube 5, comprising a first expansion lumen, a second expansion lumen and a guidewire lumen;

[0033] A first balloon 2, which is made of a non-compliant material, with both ends of the first balloon 2 sealedly connected to the surface of the tube body, and the first balloon 2 is in communication with the first expansion cavity;

[0034] The second balloon 4 is made of a compliant material, one end of the second balloon 4 is sealed and connected to the surface of the first balloon 2, and the other end is sealed and connected to the surface of the tube body, part of the surface of the first balloon 2 and part of the surface of the tube body are located inside the second balloon 4, and the second balloon 4 is connected to the second expansion cavity.

[0035] A front soft head 1 is provided at the front end of the three-lumen tube 5, and a developing mark 3 is provided on the three-lumen tube 5.

[0036] Specifically, as an optional implementation in this embodiment, Figures 2 to 4 As shown, the second balloon 4 is made of a polyurethane film.

[0037] Specifically, as an optional implementation in this embodiment, Figures 2 to 4 As shown, the second balloon 4 and the tube body are sealed by dispensing glue or dipping with polyurethane material.

[0038] Non-compliant materials such as PA, Pebax, etc.

[0039] The front end of the second balloon 4 is connected to the outer surface of the first balloon 2 , and the rear end thereof is connected to the three-lumen tube 5 .

[0040] The first expansion cavity, the second expansion cavity and the rear end of the guidewire cavity are respectively connected to the corresponding connecting piece 6 and the handle 7.

[0041] Liquid or gas is injected into the second expansion cavity through the corresponding handle 7 and connector 6, and the second balloon 4 expands.

[0042] Another embodiment of the present application provides a method for manufacturing the above-mentioned dilatation and occlusion balloon catheter, which is described in detail below.

[0043] A method for manufacturing the above-mentioned expansion and occlusion balloon catheter comprises:

[0044] Step S01, select a three-lumen tube 5, and install the first balloon 2 on the three-lumen tube 5;

[0045] Step S02, the first balloon 2 and the tube body are lined with a sleeve where the second balloon 4 is needed, and a liquid of polyurethane material is used to impregnate the first balloon 2 and the surface of the catheter through an immersion method. After the immersion is completed, the lining sleeve is pulled out, and the polyurethane film is covered on the first balloon 2. Then, the opening of the film is sealed with the tube body of the three-lumen tube 5 by dispensing or dipping with polyurethane material, and the second balloon 4 is installed.

[0046] The installation of the first balloon 2 on the three-lumen tube 5 is a conventional method, which will not be described in detail here. The core of the manufacturing method is how to manufacture the second balloon 4.

[0047] Another embodiment of the present application provides a method for using the above-mentioned dilatation and occlusion balloon catheter, which is described in detail below.

[0048] The method for using the above-mentioned expansion and occlusion balloon catheter is to send the guide wire to the distal end of the stenosis and leave it there, then insert the guide wire into the guide wire cavity of the balloon catheter, and place the balloon catheter at the lesion site through the guide wire. If the lesion site is stenosis, use a pressure pump to inject liquid into the first expansion cavity, the first balloon 2 is slowly expanded, the stenosis is slowly torn open, and the pressurization is stopped after reaching the working pressure, and the pressure is maintained. After the expansion reaches the ideal effect, the first balloon 2 is depressurized and the balloon catheter is taken out;

[0049] If bleeding occurs at the lesion site during the operation, the second balloon 4 is placed at the bleeding site, and liquid is injected into the second expansion chamber. The second balloon 4 slowly expands to block the bleeding site to control bleeding and prevent blood from flowing into a specific area, thereby providing a clear field of vision and working space for surgical operations.

[0050] The expansion and blocking balloon catheter of the present invention can also be used in interventional treatment of the urinary system. The operating steps are the same as above. The first balloon 2 can be used to expand ureteral stenosis, and the second balloon 4 can be used to temporarily block the urethra, ureter or bladder to facilitate surgery or treatment operations. It can help doctors control urine flow and prevent urine contamination and leakage.

[0051] The expansion and blocking balloon catheter of the present invention can also be used in interventional treatment of the digestive system. The operation steps are the same as above. The first balloon 2 can be used to expand the digestive tract stenosis, and the second balloon 4 can be used to temporarily block the common bile duct, gallbladder, etc. for surgical treatment or sampling. It can help doctors better locate and treat the lesion site and reduce liquid leakage or contamination.

[0052] The dilatation and blocking balloon catheter of the present invention can also be used in bronchial interventional treatment. The operation steps are the same as above. The first balloon 2 can be used to dilate airway stenosis, and the second balloon 4 can be used to block the bronchus and control the airflow rate of the patient's breathing.

[0053] The various devices selected in this application (components whose specific structures are not described) are all universal standard parts or components known to technical personnel in this field, and their structures and principles can be known to technical personnel through technical manuals or through conventional experimental methods.

[0054] In the description of the embodiments of the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0055] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0056] In the several embodiments provided in the present application, it should be understood that the disclosed systems, devices and methods can be implemented in other ways. The device embodiments described above are merely schematic. For example, the division of the units is only a logical function division. There may be other division methods in actual implementation. For example, multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some communication interfaces, and the indirect coupling or communication connection of devices or units can be electrical, mechanical or other forms.

[0057] The units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed on multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0058] In addition, each functional unit in each embodiment of the present invention may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit.

[0059] Based on the above ideal embodiments of the present invention, the relevant staff can make various changes and modifications without departing from the technical concept of the present invention through the above description. The technical scope of the present invention is not limited to the contents of the specification, and its technical scope must be determined according to the scope of the claims.

Claims

1. A dilatation and occlusion balloon catheter, characterized in that: include A three-lumen tube (5), comprising a first expansion lumen, a second expansion lumen, and a guidewire lumen; A first balloon (2) is made of a non-compliant material, both ends of the first balloon (2) are sealedly connected to the surface of the tube body, and the first balloon (2) is in communication with the first expansion cavity; The second balloon (4) is made of a compliant material, one end of the second balloon (4) is sealedly connected to the surface of the first balloon (2), and the other end of the second balloon (4) is sealedly connected to the surface of the tube body, part of the surface of the first balloon (2) and part of the surface of the tube body are located inside the second balloon (4), and the second balloon (4) is connected to the second expansion cavity.

2. The dilatation and occlusion balloon catheter according to claim 1, characterized in that: The second balloon (4) is made of a polyurethane film.

3. The dilatation and occlusion balloon catheter according to claim 1, characterized in that: The second balloon (4) and the tube body are sealed by dispensing glue or dipping with polyurethane material.

4. A method for manufacturing the dilatation and occlusion balloon catheter according to claim 1, characterized in that: include Step S01, selecting a three-lumen tube (5), and installing the first balloon (2) on the three-lumen tube (5); Step S02, a sleeve is placed on the first balloon (2) and the tube body where the second balloon (4) is needed, and a liquid made of polyurethane material is impregnated on the surface of the first balloon (2) and the catheter by an impregnation method. After the impregnation is completed, the sleeve is pulled out, and a polyurethane film is placed on the first balloon (2). Then, the opening of the film is sealed with the tube body of the three-lumen tube (5) by dispensing or dipping with polyurethane material, and the second balloon (4) is installed.

5. A method for using the dilatation and occlusion balloon catheter according to claim 1, characterized in that: The guide wire is sent to the distal end of the stenosis and left there, and then the guide wire is inserted into the guide wire cavity of the balloon catheter, and the balloon catheter is placed at the lesion site through the guide wire. If the lesion site is stenotic, a pressure pump is used to inject liquid into the first expansion cavity, and the first balloon (1) is slowly expanded, and the stenosis is slowly torn open. After reaching the working pressure, the pressure is stopped and maintained. After the expansion reaches the ideal effect, the pressure of the first balloon (1) is relieved and the balloon catheter is removed; If bleeding occurs at the lesion site during the operation, the second balloon (4) is placed at the bleeding site, and liquid is injected into the second expansion chamber. The second balloon (4) slowly expands to block the bleeding site, thereby controlling the bleeding and preventing the blood from flowing into a specific area, thereby providing a clear field of vision and working space for the surgical operation.

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