Balloon occlusion microcatheter

Abstract

The application discloses a balloon blocking microcatheter, which comprises a catheter seat, an inner tube, an outer tube, a balloon tube, a developing ring, a soft tip and a stress release tube, and the inner tube has a three-layer structure, namely an inner layer, an intermediate layer and an outer layer. The intermediate layer is a unique hypotube structure, so that the balloon blocking microcatheter has excellent passability in the blood vessel, and the inner cavity is not compressed, so that the subsequent treatment instrument or medicine can enter the body normally and smoothly, thereby improving the treatment effect and safety of the instrument as a whole. The catheter seat has two independent channels, which can avoid the possibility of intercommunication of the two cavities under high injection pressure, thereby improving the use success rate of the instrument. The balloon is made of silicone rubber material and has super high compliance, which can fit and block complex blood vessel channels, thereby improving the overall treatment effect.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a balloon occlusion microcatheter. BACKGROUND

[0002] The balloon occlusion microcatheter is mainly used for treating cell carcinogenesis caused by peripheral, nerve and coronary arteries. The treatment method mainly causes embolism of blood supply arteries of tumors to cause tumor ischemia and hypoxia, so as to achieve the purpose of inhibiting tumor growth, promoting tumor cell necrosis and apoptosis and controlling disease. The specific operation is that the balloon occlusion microcatheter is introduced into a blood vessel through a guide catheter and a micro guide wire, the balloon body is delivered to a diseased blood vessel site, the balloon is inflated to expand the balloon body. When the balloon body is inflated to a certain diameter, it exerts pressure on the blood vessel to block the blood vessel passage, and the head end of the balloon occlusion microcatheter is closer to the tumor site, the micro guide wire in the catheter is withdrawn, and a mixed emulsion of microspheres, iodine oil and various chemotherapy drugs is injected into the tumor site for embolism, so as to cause tumor cell necrosis and apoptosis and control the disease.

[0003] In the prior art, the balloon has poor compliance, the balloon cannot well adhere to the blood vessel after expansion, and the blood flow occlusion effect is poor; when the distal end of the catheter body is bent, the inner cavity is deformed, so that the subsequent instruments and drugs cannot pass normally; the injection cavity of the catheter seat is connected with the inflation cavity, and when used, the liquid in the injection cavity is easily introduced into the inflation cavity, resulting in operation failure; therefore, it is urgent to design a balloon occlusion microcatheter with high compliance, high folding resistance and better treatment effect. SUMMARY

[0004] The purpose of the present application is to overcome the deficiencies in the prior art, provide a balloon occlusion microcatheter, which can improve the balloon occlusion effect and the problem of damage to the blood vessel caused by compression during operation; secondly, the possibility of the drug in the injection cavity entering the inflation cavity under high injection pressure is avoided, so that the operation can be carried out more smoothly; finally, the middle layer of the inner tube of the balloon occlusion microcatheter adopts a special hypotube structure, so that the balloon occlusion microcatheter as a whole has excellent passability in the blood vessel, and the inner cavity of the inner tube is not compressed, so that the subsequent treatment instruments or drugs can enter the body normally and smoothly, thereby improving the treatment effect and safety of the instrument as a whole.

[0005] To achieve the above purpose, the present application provides a balloon occlusion microcatheter and a manufacturing method, which comprises a catheter seat, the catheter seat is arranged at the proximal end of the balloon occlusion microcatheter and has two independent cavities, namely an injection cavity and an inflation cavity, wherein the injection cavity is connected with the inner tube to form a channel for instruments and drugs, and the inflation cavity is connected with the outer tube to form an inflation channel.

[0006] An inner tube having a three-layer composite structure, namely an inner layer, a middle layer and an outer layer, respectively, the middle layer being a hypotube structure; the inner tube having an internal lumen for delivering instruments and drugs.

[0007] An outer tube arranged on the outer surface of the inner tube and coaxial with the inner tube, wherein the gap between the inner surface of the outer tube and the outer surface of the inner tube is 0.03-0.08mm, whereby a lumen is formed between the inner surface of the outer tube and the outer surface of the inner tube, the surface of the outer tube having a hydrophilic coating or a hydrophobic coating, the distal end surface of the outer tube having an annular groove, the distal end of the outer tube being fixedly connected to the proximal end of the balloon tube, and the proximal end of the outer tube being fixedly connected to the catheter seat.

[0008] A balloon tube having high compliance and coated with a silicone oil coating on the outer surface, the proximal end of the balloon tube being fixedly connected to the distal end of the outer tube, and the distal end of the balloon tube being fixedly connected to the distal end of the inner tube, whereby a filling cavity is formed between the balloon tube and the inner tube, and the balloon tube filling cavity forms a spherical filling state after being injected with a filling liquid.

[0009] Two visualization rings, a first visualization ring being radially arranged on the outer surface of the distal end of the balloon tube, and a second visualization ring being radially arranged between the outer surface of the hypotube and the outer layer of the distal end of the inner tube.

[0010] A soft tip arranged at the distal end of the inner tube and fixedly welded to the inner tube, mainly serving to avoid puncturing the blood vessel when entering the blood vessel.

[0011] A stress relief tube mainly serving to buffer and prevent bending at the connection points of the inner tube, the outer tube and the catheter seat, and to release stress.

[0012] Further, the balloon tube is preferably made of silicone rubber material, has a length of 5-15mm, and is coated with a silicone oil coating on the outer surface, and the hardness of the silicone rubber is ≤35A.

[0013] Further, the inner diameter of the balloon tube is smaller than the outer diameter of the inner tube, and the balloon tube needs to be assembled with the inner tube and the outer tube in an expanded state.

[0014] Further, the distal end surface of the balloon tube is 5-7mm away from the distal end surface of the inner tube, the second visualization ring is pressed on the outer surface of the distal end of the balloon tube and is 0.5-1mm away from the distal end surface of the balloon tube, the outer surface of the distal end of the balloon tube and the visualization ring are covered by a heat shrink tube, and the distal end surface of the heat shrink tube exceeds the distal end surface of the balloon tube by 1-2mm, the part of the heat shrink tube exceeding the distal end surface of the balloon tube is covered by the soft tip, and the distal end surface of the soft tip exceeds the distal end surface of the inner tube by 3-5mm.

[0015] Further, the proximal end of the balloon tube is coated on the distal end of the outer tube by 2-4 mm, and the outer surface of the coated area is coated with a heat shrink tube.

[0016] Further, the hypotube is formed by laser cutting of any one of stainless steel, nickel-titanium alloy, platinum-iridium alloy and cobalt-chromium alloy, and the hypotube can be axially stretched and compressed.

[0017] Further, the outer tube material can be any one of thermoplastic polyurethane rubber, polyimide and block polyether amide resin, or two or three material segments are spliced by hot melting. The annular groove shape of the distal end surface of the outer tube is trapezoidal, the ratio of the short side length of the trapezoid to the trapezoid height is 1:2, the ratio of the long side length of the trapezoid to the trapezoid height is 1:1, and the spacing between each trapezoidal groove is less than 0.3 mm, so that the friction coefficient of the distal end surface of the outer tube is greater than 0.6.

[0018] Further, in another example, the distal end surface of the outer tube is subjected to surface etching treatment with potassium dichromate reagent.

[0019] Further, in another example, the catheter seat has two interconnected cavities, and the surface of the injection cavity for connecting and fixing the inner tube is threaded with a pitch of 0.5-1 mm, and the connection is fixed by light-cured glue, and the threaded groove is filled with light-cured glue.

[0020] Further, in another example, the inner tube middle layer is a single layer of stainless steel braided wire structure.

[0021] Further, in another example, the inner tube middle layer is a two-layer structure, which is an inner layer and an outer layer.

[0022] Compared with the prior art, the technical scheme of the present application has the following beneficial effects:

[0023] (1) The balloon tube of the balloon occlusion microcatheter is made of silicone rubber material, so that the balloon tube has high compliance when it is filled, and is closely attached to the inner wall of the blood vessel, and has better blood flow occlusion effect in complex blood vessels.

[0024] (2) The outer surface of the balloon tube is coated with a silicone oil coating, so that the friction in the instrument or blood vessel is smaller, and the connection between the balloon tube and the outer tube is fixed by glue and a heat shrink tube, so that the sealing property is satisfied, and the overall outer diameter is smaller, so that the product has better pushability and safety.

[0025] (3) The middle layer of the distal end of the inner tube adopts a special hypotube structure, so that the size of the inner cavity can be guaranteed when the product is in a curved state, so that the subsequent instruments and drugs can pass normally, and the overall treatment effect is improved.

[0026] (4) The special lumen design of the catheter hub avoids the problem that the injection lumen drug enters the filling lumen when the product is used at a high injection pressure. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 is a structural schematic diagram of a balloon occlusion microcatheter of the present application;

[0028] Figure 2 is an enlarged schematic diagram of the local structure of the proximal end position of the balloon occlusion microcatheter of the present application;

[0029] Figure 3 is an enlarged schematic diagram of the local structure of the distal end position of the balloon occlusion microcatheter of the present application;

[0030] Figure 4 is a cross-sectional schematic diagram of the inner tube of the balloon occlusion microcatheter of the present application;

[0031] Figure 5 is a structural schematic diagram of the hypotube in a compressed state of the balloon occlusion microcatheter of the present application;

[0032] Figure 6 is a structural schematic diagram of the hypotube in a stretched state of the balloon occlusion microcatheter of the present application;

[0033] Figure 7 is a structural schematic diagram of another catheter hub of the balloon occlusion microcatheter of the present application;

[0034] Figure 8 is a cross-sectional schematic diagram of the outer tube of the balloon occlusion microcatheter of the present application;

[0035] In the figure: 01, catheter hub; 02, stress relief tube; 03, outer tube; 04, inner tube; 05, heat shrink tube; 06, heat shrink tube; 07, balloon material tube; 08, first developing ring; 09, second developing ring; 10, soft tip; 11, hypotube (the middle layer of the inner tube); 12, the outer layer of the inner tube; 13, the inner layer of the inner tube. DETAILED DESCRIPTION

[0036] In order to make the above-mentioned purposes, features and advantages of the present application more clear and easy to understand, the specific embodiments of the present application will be described and explained in detail below in combination with the drawings. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative labor are within the scope of protection of the present application.

[0037] In the present application, "proximal end" refers to the end closer to the operator of the balloon occlusion microcatheter, and "distal end" refers to the end farther from the operator of the balloon occlusion microcatheter. In addition, the terms "first", "second", "third" and the like are used to distinguish between different objects, and do not necessarily indicate or imply a chronological order or a specific order.

[0038] "Second", "additional", "another", "one", "other" and "further" are used merely for convenience and are not intended to indicate or imply relative importance or identify a number of a feature. Thus, features defined with "first", "second" or the like can include one or more of the features. In the description of the present disclosure, the meaning of "a plurality" is two or more, unless otherwise specified.

[0039] As shown in Figure 1 and Figure 2 , the proximal and distal ends of the outer tube 03 and the inner tube 04 of the balloon occlusion microcatheter are connected with the catheter seat 01 and the balloon tube 07 respectively to form a coaxial double lumen structure, and the working principle of the balloon occlusion microcatheter is to enter the lesion area under the guidance of the micro guide wire and the catheter after femoral artery or radial artery puncture, inject contrast medium into the balloon to make it fill, occlude the blood vessel and form low pressure in the lesion area, then inject drugs into the lesion area through the inner tube, and after treatment, the balloon is depressurized and the balloon occlusion microcatheter is withdrawn.

[0040] As shown in Figure 1 and Figure 3 , the outer surface of the balloon tube 07 is coated with a silicone oil coating, the distal end surface of the balloon tube 07 is 2-4mm away from the distal end surface of the inner tube 04, the first developing ring 08 on the distal end surface of the balloon tube 07 is 0.5-2mm away from the distal end surface of the balloon tube 07, the distal end surface of the balloon tube 07 and the first developing ring 08 are covered by the heat shrink tube 06, and the distal end surface of the heat shrink tube 06 exceeds the distal end surface of the balloon tube 07 by 1-2mm, the part of the heat shrink tube 06 exceeding the distal end surface of the balloon tube 07 is welded and covered by the soft tip 10, and the distal end surface of the soft tip 10 exceeds the distal end surface of the inner tube 04 by 3-5mm.

[0041] As shown in Figure 7 , another design of the catheter seat, the catheter seat has two communicating cavities, and the injection cavity surface for connecting and fixing the inner tube is threaded, with a pitch of 0.5-1mm, and the connection is fixed by light curing glue, and the thread is filled with light curing glue.

[0042] As shown in Figure 1 , the proximal end of the balloon tube 07 is covered at the distal end of the outer tube 03 with a covering distance of 2-4mm, and the outer surface of the covered area is coated with a heat shrink tube 05, and the proximal end surface of the heat shrink tube 05 exceeds the proximal end surface of the balloon tube 07 by 3-5mm.

[0043] As shown in Figure 8 , the distal end surface of the outer tube has an annular trapezoidal groove, the ratio of the length of the short side of the trapezoid to the height of the trapezoid is 1:2, and the ratio of the length of the long side of the trapezoid to the height of the trapezoid is 1:1, and the distance between each trapezoidal groove is less than 0.3mm, so that the friction coefficient of the distal end surface of the outer tube is greater than 0.6.

[0044] AsFigure 3 As shown, the inner layer 13 of the inner tube 04 is made of polytetrafluoroethylene and the outer surface is etched; the outer layer 12 of the inner tube 04 is made of nylon (PA) and polyamide (Pebax); the middle layer of the inner tube 04 is a hypotube 11 structure, which can be axially stretched and compressed.

[0045] As shown, the balloon tube is made of silicone rubber material, the outer surface is coated with a silicone oil coating, the tube thickness is 0.05-0.2mm, the hardness is less than or equal to 35A, the diameter of the inflated balloon is 3-7mm, and the inflated length is 5-15mm. Figure 1 As shown, the outer surface of the outer tube 03 is coated with a hydrophilic coating or a hydrophobic coating.

[0046] Figure 1 As shown, the distal end is a hypotube 10 structure formed by laser cutting of a stainless steel tube, which can be axially stretched and compressed, is the structure of the hypotube 10 in the compressed state,

[0047] is the structure of the hypotube 10 in the stretched state. Figure 5 Figure 6 As shown, the distal end is a hypotube 10 structure formed by laser cutting of a stainless steel tube, which can be axially stretched and compressed, Figure 2 is the structure of the hypotube 10 in the compressed state, Figure 3 is the structure of the hypotube 10 in the stretched state.

[0048] The above is only the preferred embodiment of the present application, not the limit of the patent scope of the present application, any equivalent structure or equivalent process transformation using the content of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.​

Claims

1. A balloon occlusion microcatheter, comprising a catheter seat, an inner tube, an outer tube, a balloon material tube, a radiopaque ring, a soft tip, and a stress relief tube, characterized in that: The catheter hub has two special cavities: an injection cavity and a filling cavity. The inner tube has a three-layer structure: an inner layer, a middle layer, and an outer layer. The middle layer is a metal submersible tube structure that can undergo axial stretching and compression changes while maintaining a constant inner diameter. The distal end of the balloon tubing is fixed to the surface of the inner tube by a radiopaque ring and a heat-shrink tubing. The proximal end of the balloon tubing covers the distal outer surface of the outer tube and is fixed by heat-shrink tubing. The distal surface of the outer tube has multiple annular grooves.

2. The balloon occlusion microcatheter according to claim 1, characterized in that: The injection cavity and the filling cavity are independent of each other and do not communicate with each other. The injection cavity is connected to the inner tube, and the filling cavity is connected to the outer tube, and they are connected in an integral co-molding form.

3. The balloon occlusion microcatheter according to claim 1, characterized in that: The proximal end of the inner tube is connected and fixed to the injection cavity of the catheter seat; the thiopancreatic tube is formed by laser cutting of a metal tube, and the thiopancreatic tube can undergo axial stretching and compression.

4. The balloon occlusion microcatheter according to claim 1, characterized in that: The proximal end of the outer tube is heated and expanded, then connected and fixed to the filling cavity of the catheter seat; the distal end of the outer tube is connected and fixed to the balloon material tube. The annular groove on the distal surface of the outer tube is trapezoidal in shape, with the ratio of the short side length to the height of the trapezoid being 1:2 and the ratio of the long side length to the height of the trapezoid being 1:

1. The spacing between each trapezoidal groove is less than 0.3 mm, and the coefficient of friction of the distal surface of the outer tube is greater than 0.

6.

5. The balloon occlusion microcatheter according to claim 1, characterized in that: The distal end of the balloon tube is held by the imaging ring and fixed with heat shrink tubing on the outer surface of the balloon tube. The outer surface of the heat shrink tubing is welded and covered by the soft tip. The proximal end of the balloon tube is covered by the distal end of the outer tube and the outer surface of the covered area is fixed with heat shrink tubing.

6. The balloon occlusion microcatheter according to claim 1, characterized in that: The balloon tubing is made of silicone rubber with a thickness of 0.05-0.15 mm and a hardness of 35A or less. The inflated balloon has a diameter of 3-7 mm and an inflated length of 5-15 mm.

7. The balloon occlusion microcatheter according to claim 1, characterized in that: The outer surface of the balloon tube is coated with a silicone oil coating.

8. The balloon occlusion microcatheter according to claim 1, characterized in that: The inner diameter of the balloon material tube is smaller than the outer diameter of the inner tube and the outer tube. The proximal end of the balloon material tube is expanded by heating and then wrapped around the distal surface of the outer tube and fixed by heat shrink tubing.

9. A balloon occlusion microcatheter according to claim 1, characterized in that: The outer tube material can be any one of thermoplastic polyurethane rubber, polyimide, and block polyether amide resin, or it can be formed by hot-melting and splicing two or three material segments.

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