Balloon plugging micro catheter

Abstract

The balloon plugging micro catheter comprises a catheter base, an inner tube, an outer tube, a balloon material tube, a developing ring, a soft tip end and a stress release tube, the inner tube is of a three-layer structure which comprises an inner layer, a middle layer and an outer layer, the middle layer is of a unique hypotube structure, and the outer layer is of a unique hypotube structure. According to the balloon plugging micro-catheter, the catheter seat is provided with the two independent channels, so that the whole balloon plugging micro-catheter has excellent trafficability in a blood vessel, meanwhile, the inner cavity can be prevented from being pressed, accordingly, follow-up treatment instruments or medicines can normally and smoothly enter a human body, and the overall treatment effect and safety of the instruments are improved; the possibility that the two cavities communicate with each other under high injection pressure is avoided, the use success rate of the instrument is increased, the balloon is made of silicon rubber materials, has ultrahigh compliance and can be attached to and block a complex blood vessel channel, and therefore the overall treatment effect is improved.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a balloon occlusion microcatheter. Background Art

[0002] The balloon occlusion microcatheter is mainly used to treat cell carcinogenesis caused by peripheral, neural and coronary arteries. The treatment method mainly embolizes the blood supply artery of the tumor, causing tumor ischemia and hypoxia, so as to inhibit tumor growth, promote tumor cell necrosis and apoptosis, and thus control the disease. The specific operation is to pass the balloon occlusion microcatheter into the blood vessel through the guide catheter and micro-guidewire, transport the balloon body to the diseased blood vessel site, and fill the balloon to expand the balloon body. When the balloon body is filled to a certain diameter, it exerts pressure on the blood vessel, thereby closing the vascular pathway and bringing the tip of the balloon occlusion microcatheter closer to the tumor site. The micro-guidewire in the catheter is withdrawn, and a mixed emulsion of microspheres, iodized oil and various chemotherapy drugs is injected into the tumor site for embolization, thereby causing tumor cell necrosis and apoptosis, thereby controlling the disease.

[0003] In the prior art, the balloon has poor compliance, and after expansion, the balloon cannot fit the blood vessel well, resulting in poor blood flow blocking effect; when the distal end of the catheter body is bent, the inner cavity is deformed, resulting in subsequent instruments and drugs cannot pass normally; the injection cavity and the filling cavity of the catheter seat are connected, and when used, it is easy to cause the liquid in the injection cavity to enter the filling cavity, resulting in surgical failure; therefore, it is urgent to design a balloon occlusion microcatheter with high compliance, high folding resistance and better therapeutic effect. Summary of the invention

[0004] The purpose of the present invention is to overcome the deficiencies in the prior art and provide a balloon occlusion microcatheter. Firstly, the balloon occlusion microcatheter can improve the balloon occlusion effect during surgery and the problem of damage to blood vessels caused by compression; secondly, it avoids the possibility of drugs in the injection cavity entering the filling cavity under a higher injection pressure, thereby allowing the surgery to proceed 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 permeability in the blood vessel, while also ensuring that the inner cavity of the inner tube is not compressed, so that the subsequent treatment equipment or drugs can enter the body normally and smoothly, thereby improving the overall treatment effect and safety of the equipment.

[0005] To achieve the above-mentioned objectives, the present invention proposes a balloon occlusion microcatheter and a manufacturing method, comprising a catheter seat, which is arranged at the proximal end of the balloon occlusion microcatheter and has two independent cavities, namely an injection cavity and a filling cavity, wherein the injection cavity is connected to the inner tube to form a channel for introducing instruments and drugs, and the filling cavity is connected to the outer tube to form a filling channel.

[0006] The inner tube has a three-layer composite structure, namely an inner layer, a middle layer and an outer layer, wherein the middle layer is a hypotube structure; the inner tube has an internal cavity for conveying instruments and drugs.

[0007] An outer tube, wherein the outer tube is arranged on the outer surface of the inner tube and is 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 0.03-0.08 mm, thereby forming a cavity between the inner surface of the outer tube and the outer surface of the inner tube, the surface of the outer tube has a hydrophilic coating or a hydrophobic coating, the distal surface of the outer tube has an annular groove, the distal end of the outer tube is connected and fixed to the proximal end of the balloon material tube, and the proximal end of the outer tube is connected and fixed to the catheter seat.

[0008] A balloon tube, which is highly compliant and coated with silicone oil on the outer surface; the proximal end of the balloon tube is connected and fixed to the distal end of the outer tube, and the distal end of the balloon tube is connected and fixed to the distal end of the inner tube, thereby forming a filling cavity between the balloon tube and the inner tube, and after the filling liquid is injected, the filling cavity of the balloon tube is formed into a spherical filled state.

[0009] The developing rings include two developing rings, a first developing ring is radially arranged on the outer surface of the distal end of the balloon material tube, and a second developing ring is radially arranged between the outer surface of the hypotube at the distal end of the inner tube and the outer layer.

[0010] The soft tip is arranged at the distal end of the inner tube and is fixed to the inner tube by welding, and mainly serves to prevent the distal end face from piercing the blood vessel when entering the blood vessel.

[0011] A stress release tube, which mainly serves to buffer and prevent bending and release stress at the connection points of the inner tube, the outer tube and the catheter seat;

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

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

[0014] Furthermore, the distal end face of the balloon tube is 5-7mm away from the distal end face of the inner tube, the second developing ring is pressed on the distal outer surface of the balloon tube and is 0.5-1mm away from the distal end face of the balloon tube, the distal outer surface of the balloon tube and the developing ring are covered by a heat shrink tube and the distal end face of the heat shrink tube protrudes from the distal end face of the balloon tube by 1-2mm, the portion of the heat shrink tube protruding from the distal end face of the balloon tube is covered by the soft tip, and the distal end face of the soft tip protrudes from the distal end face of the inner tube by 3-5mm.

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

[0016] Furthermore, the hypotube is formed by laser cutting a metal tube of any one of stainless steel, nickel-titanium alloy, platinum-iridium alloy and cobalt-chromium alloy, and the hypotube can undergo axial stretching and compression changes.

[0017] Furthermore, the outer tube material can be any one of thermoplastic polyurethane rubber, polyimide and block polyetheramide resin, or two or three material segments can be formed by hot-melt splicing. The annular groove on the distal surface of the outer tube is in the shape of a trapezoid, the ratio of the short side length of the trapezoid to the height of the trapezoid is 1:2, the ratio of the long side length of the trapezoid to the height of the trapezoid is 1:1, and the spacing between each trapezoidal groove is less than 0.3mm, so that the friction coefficient of the distal surface of the outer tube is greater than 0.6.

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

[0019] Furthermore, 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 engraved with threads, the pitch of which is between 0.5-1mm, and the connection is fixed by light-curing glue, and the thread pattern is filled with light-curing glue.

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

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

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

[0023] (1) The balloon material tube of the balloon occlusion microcatheter of the present invention is made of silicone rubber, so that the balloon material tube has strong compliance when it is filled, and fits more closely with the inner wall of the blood vessel, and has a better blood flow occlusion effect in complex blood vessels.

[0024] (2) The outer surface of the balloon tube is coated with silicone oil, which reduces the friction in the device or blood vessel. The connection between the balloon tube and the outer tube is fixed with glue and heat shrink tubing, which ensures that the overall outer diameter is smaller while meeting the sealing requirements, making the product more pushable and safer.

[0025] (3) The middle layer at the distal end of the inner tube adopts a special hypotube structure, which ensures the size of the inner cavity even when the product is in a bent state, allowing subsequent instruments and drugs to pass normally, thereby improving the overall treatment effect.

[0026] (4) The special cavity design of the catheter hub prevents the problem of drugs in the injection cavity entering the filling cavity when the product is used under high injection pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a schematic diagram of the structure of the balloon occlusion microcatheter of the present invention;

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

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

[0030] Figure 4 It is a schematic diagram of the inner tube cross section of the balloon occlusion microcatheter of the present invention;

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

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

[0033] Figure 7 It is a structural schematic diagram of another catheter seat of the balloon occlusion microcatheter of the present invention;

[0034] Figure 8 is a schematic diagram of the outer tube cross section of the balloon occlusion microcatheter of the present invention;

[0035] In the figure: 01, catheter seat; 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, sea wave tube (middle layer of the inner tube); 12, outer layer of the inner tube; 13 inner layer of the inner tube. DETAILED DESCRIPTION

[0036] In order to make the above-mentioned purposes, features and advantages of the present invention more clearly understood, the specific implementation methods of the present invention are described in detail below in conjunction with the accompanying drawings. 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.

[0037] The "proximal end" referred to in this application refers to the end closer to the operator of the balloon occlusion microcatheter, and the "distal end" refers to the end farther from the operator of the balloon occlusion microcatheter.

[0038] "Second", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the present disclosure, unless otherwise specified, "plurality" means two or more.

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

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

[0041] like Figure 7 As shown, another design of the catheter seat is that the catheter seat has two interconnected cavities, and the surface of the injection cavity used to connect and fix the inner tube is engraved with threads, and the pitch is between 0.5-1mm. The connection is fixed by light-curing glue, and the thread pattern is filled with light-curing glue.

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

[0043] like Figure 8 As shown, the distal surface of the outer tube has an annular trapezoidal groove, 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 0.3mm, thereby making the friction coefficient of the distal surface of the outer tube greater than 0.6.

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

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

[0046] like Figure 1 As shown, the outer surface of the outer tube 03 is coated with a hydrophilic coating or a hydrophobic coating.

[0047] like Figure 5 and Figure 6 As shown, the distal end is a hypotube 10 structure formed by laser cutting of a stainless steel tube. The hypotube 10 can undergo axial stretching and compression changes. Figure 2 This is the structure of the hypotube 10 in a compressed state. Figure 3 It is the structure of the hypotube 10 in the stretched state.

[0048] The above description is only a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made by using the contents of the present invention specification and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A balloon occlusion microcatheter, comprising a catheter seat, an inner tube, an outer tube, a balloon material tube, a developing ring, a soft tip and a stress release tube, characterized in that: The catheter seat has two special cavities, namely an injection cavity and a filling cavity; the inner tube has a three-layer structure, namely an inner layer, a middle layer and an outer layer, and the middle layer is a metal sea wave tube structure that can undergo axial stretching and compression changes while keeping the inner diameter constant; the distal end of the balloon material tube is fixed to the surface of the inner tube by a developing ring and a heat shrink tube; the proximal end of the balloon material tube is coated on the distal outer surface of the outer tube and fixed with a heat shrink tube, and the distal surface of the outer tube has a plurality of 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 are not interconnected. 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 hypotube is formed by laser cutting a metal tube, and the hypotube can undergo axial stretching and compression changes.

4. The balloon occlusion microcatheter according to claim 1, characterized in that: The proximal end of the outer tube is heated and expanded and 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, and the annular groove on the distal surface of the outer tube is trapezoidal in shape, the ratio of the short side length of the trapezoid to the height of the trapezoid is 1:2, the ratio of the long side length of the trapezoid to the height of the trapezoid is 1:1, the spacing between each trapezoidal groove is less than 0.3 mm, and the friction coefficient 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 material tube is pressed and gripped by the developing ring, and a heat shrink tube is applied on the outer surface of the balloon material tube for fixation, and the outer surface of the heat shrink tube is welded and covered by the soft tip; the proximal end of the balloon material tube is covered on the distal end of the outer tube and the outer surface of the covered area is fixed with a heat shrink tube.

6. The balloon occlusion microcatheter according to claim 1, characterized in that: The balloon material tube is made of silicone rubber material, the thickness of the tube is 0.05-0.15mm, the hardness is less than or equal to 35A, the diameter of the filled balloon is 3-7mm, and the filled length is 5-15mm.

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 diameters of the inner tube and the outer tube. The proximal end of the balloon material tube is expanded by heating and then covered on the distal end surface of the outer tube and fixed by a heat shrink tube.

9. The 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 polyetheramide resin, or can be formed by hot-melt splicing of two or three material segments.

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