A balloon dilatation catheter

Abstract

The present invention relates to the field of medical devices, and in particular to a balloon dilatation catheter, the balloon dilatation catheter comprises a balloon body and a delivery assembly, the balloon body extends axially and has openings at both ends, the delivery assembly comprises an inner tube and an outer tube, the inner tube penetrates the balloon body through the openings at both ends of the balloon body, the outer tube is provided with a guidewire cavity, a first liquid cavity and a first liquid outlet cavity which are not connected to each other, the guidewire cavity is connected to the inner tube, the first liquid cavity is connected to the inner cavity of the balloon body, the first end of the first liquid outlet cavity is a liquid inlet, the second end is a liquid outlet, the liquid outlet is close to the balloon body and is not connected to the inner cavity of the balloon body. The balloon dilatation catheter of the present invention has angiography function, and the cavity for passing contrast fluid can be opened immediately after the balloon body is expanded, which can reduce the damage to cerebral blood vessels, and at the same time can shorten the operation time, reduce the dose of contrast agent, and reduce medical expenses.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a balloon dilatation catheter. Background Art

[0002] Neurointervention is the diagnosis and treatment of lesions involving the human neurovascular system through selective angiography, embolization, dilatation, mechanical removal, drug delivery, etc., with the support of a digital subtraction angiography (DSA) system and the use of intravascular catheter operation technology. Neurointervention is a method of treating vascular diseases in the neck or intracranial region by puncturing the femoral artery or femoral vein and using a special balloon catheter to reach the neck or intracranial vessels.

[0003] Neurointervention is mainly related to cerebrovascular disease, and is more difficult to implement than cardiovascular disease. Cerebrovascular disease is thinner than cardiovascular disease, and cerebral arteries are thin, long, tortuous, and lack elastic pulsation.

[0004] The existing technology has the following defects: 1) In traditional treatment methods, an angiography catheter is required after the balloon works to determine the effect of balloon dilation on the lesion. Various catheters, guide wires, and balloons are often switched during the operation, which may cause varying degrees of damage to the cerebral blood vessels; 2) Traditional treatment methods also prolong the operation time while replacing the device, causing the doctor to be exposed to radiation for a long time. Summary of the invention

[0005] In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide a balloon dilatation catheter for solving the problems in the prior art.

[0006] To achieve the above-mentioned purpose and other related purposes, the present invention provides a balloon dilatation catheter, which includes a balloon body and a conveying assembly. The balloon body extends axially and has openings at both ends. The conveying assembly includes an inner tube and an outer tube. The inner tube penetrates the balloon body through the openings at both ends of the balloon body. The outer tube is provided with a guidewire cavity, a first liquid cavity and a first liquid outlet cavity that are not connected to each other. The guidewire cavity is connected to the inner tube, the first liquid cavity is connected to the inner cavity of the balloon body, the first end of the first liquid outlet cavity is a liquid inlet, and the second end is a liquid outlet. The liquid outlet is close to the balloon body and is not connected to the inner cavity of the balloon body.

[0007] Preferably, a liquid outlet hole connected to the first liquid outlet cavity is provided at the liquid opening of the first liquid outlet cavity. The liquid outlet hole comprises an inflow section, a transition section and an outflow section connected in sequence, the inflow section is connected to the first liquid outlet cavity, the transition section transitions in a direction away from the axial direction of the first liquid outlet cavity, and the outlet of the outflow section faces the outer surface of the balloon body. The transition section is a right-angle transition or an arc transition.

[0008] Preferably, the conveying assembly further comprises a connecting pipe, in which a second liquid passage cavity and a second liquid outlet cavity are provided, the second liquid passage cavity is communicated with the first liquid passage cavity, and the second liquid outlet cavity is communicated with the first liquid outlet cavity.

[0009] Preferably, the conveying assembly further comprises a hypotube, wherein a third liquid passage cavity and a third liquid outlet cavity are provided in the hypotube, wherein the third liquid passage cavity is connected to the second liquid passage cavity, and the third liquid outlet cavity is connected to the second liquid outlet cavity.

[0010] Preferably, the balloon dilatation catheter is an intracranial angiography balloon dilatation catheter.

[0011] As described above, the balloon dilatation catheter of the present invention has the following beneficial effects: the balloon dilatation catheter has an angiography function, and the cavity for passing the contrast fluid can be opened immediately after the balloon body is expanded. There is no need to replace the guide wire and the angiography catheter as in the prior art, which can reduce the damage to the cerebral blood vessels caused by replacing the guide wire, catheter, and balloon; at the same time, it shortens the operation time and the time the doctor is exposed to radiation; and because the angiography position is closer to the lesion position, compared with the angiography catheter, the present invention can reduce the dose of contrast agent and reduce medical expenses. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 Shown is an overall schematic diagram of the balloon dilatation catheter of the present invention.

[0013] Figure 2 Shown is an enlarged schematic diagram of a section of the balloon dilatation catheter of the present invention.

[0014] Figure 3 Display as Figure 1 Schematic diagram of the cross section of the outer tube at the middle BB, the three figures respectively show three different implementation methods of the outer tube.

[0015] Figure 4 It shows a partial enlarged view of the liquid outlet hole, in which a is the liquid outlet direction of the first liquid outlet cavity of the balloon dilatation catheter of the present invention, and b is the liquid outlet direction of the first liquid outlet cavity of the balloon dilatation catheter in the prior art.

[0016] Figure 5 Display as Figure 1 The schematic cross-sectional view of the outer tube at AA in the middle, the three figures respectively show three different implementations of the outer tube.

[0017] Figure 6 Display as Figure 1 A schematic cross-sectional view of the connecting pipe at CC in the middle, with the three figures showing three different implementations of the connecting pipe.

[0018] Figure 7 Display as Figure 1Schematic diagram of the cross-section of the hypotube at DD in the middle, and the three figures respectively show three different implementation methods of the hypotube.

[0019] Component number description

[0020] 1 Balloon body

[0021] 21 Inner tube

[0022] 22 outer tube

[0023] 221 Guidewire Lumen

[0024] 222 First liquid chamber

[0025] 223 First liquid outlet cavity

[0026] 2231 Liquid outlet

[0027] 2231a Inflow section

[0028] 2231b Transition

[0029] 2231c Outflow segment

[0030] 23 Connecting pipe

[0031] 231 Second liquid chamber

[0032] 232 Second liquid outlet cavity

[0033] 24 Hypotube

[0034] 241 Third liquid chamber

[0035] 242 Third liquid outlet cavity

[0036] 25 Tip

[0037] 3 Y-type seat

[0038] 31 First connecting piece

[0039] 32 Second connecting piece

[0040] 4 Development Marks DETAILED DESCRIPTION

[0041] The following is a description of the implementation of the present invention by means of specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0042] Please refer to the drawings in the specification. It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings in this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change in the proportional relationship, or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the effects and purposes that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. The change or adjustment of their relative relationship should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0043] The "proximal end" in this application generally refers to the end of the corresponding component close to the operator, for example Figure 1 The lower end; "distal end" refers to the end of the corresponding component away from the operator, such as Figure 1 Upper mid-range.

[0044] like Figure 1 As shown, the present application provides a balloon dilatation catheter, which includes a balloon body 1 and a conveying assembly, wherein the balloon body 1 extends axially and has openings at both ends, and the conveying assembly includes an inner tube 21 and an outer tube 22, wherein the inner tube 21 penetrates the balloon body 1 through the openings at both ends of the balloon body 1, and the outer tube 22 is provided with a guidewire cavity 221, a first liquid passage cavity 222 and a first liquid outlet cavity 223 which are not connected to each other, wherein the guidewire cavity 221 is connected to the inner tube 21, wherein the first liquid passage cavity 222 is connected to the inner cavity of the balloon body 1, wherein the first end of the first liquid outlet cavity 223 is a liquid inlet, and the second end is a liquid outlet, wherein the liquid outlet is close to the balloon body 1 and is not connected to the inner cavity of the balloon body 1.

[0045] The material of the balloon body 1 is a heat-shrinkable elastomer. The heat-shrinkable elastomer is selected from nylon, Pebax or polyurethane. The balloon body 1 is prepared by a blow molding process.

[0046] The proximal end of the balloon body 1 is fixedly connected to the inner tube 21 and / or the outer tube 22 by laser welding or thermal welding. In one embodiment, the distal end of the balloon body 1 is fixedly connected to the distal end of the inner tube 21 and the tip 25. The fixed connection is selected from laser welding or thermal welding.

[0047] In one embodiment, the inner tube 21 is made by co-extrusion of three layers of materials. Usually, the inner layer of the inner tube 21 is a HDPE layer, the middle layer is a low-density medical grade polyethylene, and the outer layer is Pebax 7233. The inner tube 21 formed by the three layers of materials has good hardness and smoothness.

[0048] In one embodiment, the inner tube 21 is a single-lumen tube structure.

[0049] In one embodiment, the proximal end of the inner tube 21 is fixedly connected to the distal end of the guidewire cavity 221 by laser welding or thermal welding.

[0050] The inner tube 21 is connected with the guidewire cavity 221 and is used together for passing the delivery guidewire when delivering the balloon dilatation catheter. The common specifications of the delivery guidewire are 0.014 inch, 0.018 inch, 0.035 inch, etc.

[0051] In one embodiment, the outer tube 22 is made of a single layer of material. The material of the outer tube 22 is Pebax 7233, for example.

[0052] Figure 3 Three different shapes of the first liquid passage cavity 222 and the first liquid outlet cavity 223 are shown.

[0053] The liquid outlet of the first liquid outlet cavity 223 is close to the balloon body 1 and is not connected to the inner cavity of the balloon body 1, so that the liquid in the first liquid outlet cavity 223 can flow to the lesion position through the opening at the end of the first liquid outlet cavity for contrast imaging. This can prevent the contrast fluid from flowing out of the hole on the wall of the liquid outlet cavity (i.e. Figure 4 b) thereby impacting the blood vessels and causing mechanical damage to the blood vessels. That is, the outflow direction of the contrast fluid in the present invention is changed from the direction perpendicular to the blood vessels in the prior art (i.e. Figure 4 The direction of b in the figure is optimized to be parallel to the blood vessel (i.e. Figure 4 By changing the flow direction of the contrast fluid, the impact of the contrast fluid on the blood vessels when it flows out is reduced, thus protecting the blood vessels from mechanical damage.

[0054] In such Figures 2 to 4 In the preferred embodiment shown, a liquid outlet hole 2231 is provided at the liquid opening of the first liquid outlet cavity 223. The liquid outlet hole 2231 includes an inflow section 2231a, a transition section 2231b and an outflow section 2231c connected in sequence, the inflow section 2231a is connected to the first liquid outlet cavity 223, the transition section transitions to a direction away from the axial direction of the first liquid outlet cavity 223, and the outlet of the outflow section 2231c faces the outer surface of the balloon body 1.

[0055] The transition section 2231b is a right-angle transition (such as Figure 4 As shown in the right figure) or arc transition (as shown Figure 4 As shown in the left figure). One end of the liquid outlet hole 2231 is fixedly connected to the first liquid outlet cavity 223. The fixed connection is selected from laser welding, glue spotting or thermal welding.

[0056] The material of the liquid outlet 2231 is selected from medical grade PC, Nylon, Pebax and other polymer materials. The liquid outlet 2231 is used to guide the outflow of contrast fluid, and its right angle conversion structure or curved surface structure makes the outflow position of the contrast fluid closer to the blood vessel wall, which can further reduce the impact of the contrast fluid on the blood vessel when it flows out, and protect the blood vessel from mechanical damage.

[0057] In one embodiment, the conveying assembly further includes a connecting tube 23, in which a second liquid passage cavity 231 and a second liquid outlet cavity 232 are provided, wherein the second liquid passage cavity 231 is in communication with the first liquid passage cavity 222, and the second liquid outlet cavity 232 is in communication with the first liquid outlet cavity 223. The connecting tube 23 and the outer tube 22 are fixedly connected at all locations to realize the communication of the cavities. The fixed connection is selected from laser welding or thermal welding.

[0058] The connecting tube 23 is made of a single-layer material. The material of the connecting tube 23 is selected from Nylon 12, L25, ML21 or Nylon 11. In one embodiment, the connecting tube 23 is made of the above-mentioned materials through an extrusion molding process.

[0059] In one embodiment, the delivery assembly further comprises a hypotube 24, wherein a third liquid passage cavity 241 and a third liquid outlet cavity 242 are provided in the hypotube 24, wherein the third liquid passage cavity 241 is in communication with the second liquid passage cavity 231, and the third liquid outlet cavity 242 is in communication with the second liquid outlet cavity 232. The hypotube 24 and the connecting tube 23 are fixedly connected at all locations to realize the communication of the cavities. The fixed connection is selected from laser welding, thermal welding or glue dispensing.

[0060] The hypotube 24 is made of medical grade stainless steel metal pipe as the main body, and is obtained by cutting a variable diameter spiral line by laser cutting. The above structure makes the hypotube 24 rigid and anti-bending.

[0061] The shapes of the guidewire cavity 221, the first liquid-passing cavity 222 and the first liquid-discharging cavity 223, the second liquid-passing cavity 231 and the second liquid-discharging cavity 232, the third liquid-passing cavity 241 and the third liquid-discharging cavity 242 described in the present application are not specifically limited, and the cross-sections are, for example, circular, elliptical, fan-shaped, etc. However, the shapes of the interconnected cavities match each other, specifically, the guidewire cavity 221 matches the cavity shape of the inner tube 21; the third liquid-passing cavity 241 and the second liquid-passing cavity 231 match the cavity shape of the first liquid-passing cavity 222; the third liquid-discharging cavity 242 and the second liquid-discharging cavity 232 match the cavity shape of the first liquid-discharging cavity 223.

[0062] In one embodiment, the balloon dilatation catheter further comprises a Y-shaped seat 3. The Y-shaped seat 3 can be a catheter seat in the prior art. The Y-shaped seat 3 is provided with a first connecting member 31 and a second connecting member 32 which are respectively fixedly connected to the third liquid passage cavity 241 and the third liquid outlet cavity 242. The fixed connection is selected from epoxy glue bonding, UV curing, etc.

[0063] The Y-shaped seat 3 can be connected to a pressure pump for injecting contrast agent.

[0064] In one embodiment, the delivery assembly further comprises a tip 25, and the tip 25 is fixedly connected to the distal end of the inner tube 21. The fixed connection is selected from processes such as laser welding or thermal welding.

[0065] The material of the tip 25 is selected from any one or more of the following: Pebax2533, Pebax3533, Pebax5533, Nylon12L25, ML21. The tip 25 is soft and small in size, which is conducive to passing through the thrombus lesion. The tip 25 is conical. The length of the tip 25 is 3 to 5 mm, and the outer diameter is between 0.3 mm and 0.6 mm.

[0066] The balloon dilatation catheter also includes a developing mark 4, which is a developing element provided on the outer wall of the inner tube 21, or the inner tube 21 is formed with a developing mark 4. Preferably, the developing mark 4 is a developing element provided on the inner tube section inside the balloon body 1, or the inner tube section inside the balloon body 1 is formed with a developing mark 4. The developing element can be a metal ring. There are multiple developing elements. For example, there are two developing elements. Both developing elements are located on the inner tube section inside the balloon body 1. The inner tube section inside the balloon body 1 can be made of a material with a developing function to form the developing mark 4, or by coating a developer on the inner tube section inside the balloon body 1, or winding a developing wire, or forging it on the inner tube 21, etc. The material of the developing wire is selected from gold, platinum, tantalum metal, radiopaque, PtW alloy or PtIr alloy.

[0067] The balloon dilatation catheter is an intracranial angiography balloon dilatation catheter.

[0068] The balloon dilatation catheter of the present application needs to be used in conjunction with auxiliary devices such as the balloon pressurizing device in the prior art. The specific method of use is as follows:

[0069] After the delivery guide wire passes through the inner tube 21 and enters the balloon body 1, it passes through the end of the guide wire cavity 221 close to the connecting tube 23. Figure 1As shown near AA in the figure. The tip 25 enters the lesion site along the guide wire. The operator uses X-ray fluoroscopy, and the development mark 4 can indicate the position of the balloon body 1, guiding the balloon dilatation catheter to enter the blood vessel, so as to locate it at the vascular lesion; then the first connecting piece 31 connected to the Y-shaped seat 3 inputs contrast fluid into the third liquid cavity 241 through the balloon pressurizing device. The contrast fluid passes through the connecting tube 23 and the first liquid cavity 222, and enters the balloon body 1 from the distal end of the first liquid cavity 222, so that the balloon body 1 is expanded, thereby squeezing the narrow plaque at the lesion site and expanding the blood vessel lumen. The contrast fluid filled in the balloon body 1 makes it easy for the operator to observe the complete shape of the entire balloon in the blood vessel. After the balloon body 1 is expanded, the negative pressure is generated by the balloon pressurizing device to shrink the balloon body 1; after the balloon body 1 shrinks, the second connecting piece 32 connected to the Y-shaped seat 3 is controlled by the balloon pressurizing device to inject contrast fluid, so that the contrast fluid flows out from the liquid outlet 2231 to the lesion site for contrast imaging, and the balloon dilatation catheter is removed after the contrast imaging.

[0070] In summary, the balloon dilatation catheter of the present invention combines the function of contrast imaging, and also has a double-lumen structure of the hypotube and a three-lumen structure of the outer tube. After implantation, the effect of the lesion after the balloon body is expanded can be determined by contrast imaging. The function of the balloon dilatation catheter itself combined with the contrast imaging function can greatly reduce the operation time, reduce the exposure time to radiation, reduce the dosage of contrast agents, and of course, can also reduce the patient's medical expenses. At the same time, the liquid outlet changes the direction of the contrast fluid flow to reduce the impact of the contrast fluid on the blood vessels when it flows out, thereby protecting the blood vessels from mechanical damage. Therefore, the present invention effectively overcomes the various shortcomings of the prior art and has a high industrial utilization value.

[0071] The above embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Anyone familiar with the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by a person of ordinary skill in the art without departing from the spirit and technical concept disclosed by the present invention shall still be covered by the claims of the present invention.

Claims

1. A balloon dilatation catheter, characterized in that: The balloon dilatation catheter comprises a balloon body (1) and a conveying assembly. The balloon body (1) extends axially and has openings at both ends. The conveying assembly comprises an inner tube (21) and an outer tube (22). The inner tube (21) penetrates the balloon body (1) through the openings at both ends of the balloon body (1). The outer tube (22) is provided with a guidewire cavity (221), a first liquid passage cavity (222) and a first liquid outlet cavity (223) which are not connected to each other. The guidewire cavity (221) is connected to the inner tube (21). The first liquid passage cavity (222) is connected to the inner cavity of the balloon body (1). The first end of the first liquid outlet cavity (223) is a liquid inlet and the second end is a liquid outlet. The liquid outlet is close to the balloon body (1) and is not connected to the inner cavity of the balloon body (1). The liquid opening of the first liquid outlet cavity (223) is provided with a liquid inlet which is connected to the inner cavity of the balloon body (1). A connected liquid outlet hole (2231), the liquid outlet hole (2231) comprises an inflow section (2231a), a transition section (2231b) and an outflow section (2231c) which are connected in sequence, the inflow section (2231a) is connected to the first liquid outlet cavity (223), the transition section (2231b) transitions in a direction away from the axial direction of the first liquid outlet cavity (223), and the outlet of the outflow section (2231c) faces the outer surface of the balloon body (1); the conveying component also comprises a connecting tube (23) and a hypotube (24), the connecting tube (23) is provided with a second liquid outlet cavity (232), the second liquid outlet cavity (232) is connected to the first liquid outlet cavity (223); the hypotube (24) is provided with a third liquid outlet cavity (242), the third liquid outlet cavity (242) is connected to the second liquid outlet cavity (232).

2. The balloon dilatation catheter according to claim 1, characterized in that: The transition section (2231b) is selected from a right-angle transition or an arc transition.

3. The balloon dilatation catheter according to claim 1, characterized in that: A second liquid passage cavity (231) is also provided in the connecting pipe (23), and the second liquid passage cavity (231) is communicated with the first liquid passage cavity (222).

4. The balloon dilatation catheter according to claim 3, characterized in that: A third liquid passage cavity (241) is also provided in the hypotube (24), and the third liquid passage cavity (241) is communicated with the second liquid passage cavity (231).

5. The balloon dilatation catheter according to claim 4, characterized in that: The guidewire cavity (221) matches the cavity shape of the inner tube (21); and / or, the third liquid passage cavity (241), the second liquid passage cavity (231) and the first liquid passage cavity (222) all match each other in cavity shape; and / or, the third liquid outlet cavity (242), the second liquid outlet cavity (232) and the first liquid outlet cavity (223) all match each other in cavity shape.

6. The balloon dilatation catheter according to claim 4, characterized in that: The balloon dilatation catheter further comprises a Y-shaped seat (3), on which a first connecting piece (31) and a second connecting piece (32) are provided, which are respectively fixedly connected to the third liquid passage cavity (241) and the third liquid outlet cavity (242).

7. The balloon dilatation catheter according to claim 1, characterized in that: The delivery assembly further comprises a tip (25), wherein the tip (25) is fixedly connected to the distal end of the inner tube (21).

8. The balloon dilatation catheter according to claim 7, characterized in that: The distal end of the balloon body (1) is fixedly connected to the distal end and the tip (25) of the inner tube (21).

9. The balloon dilatation catheter according to claim 1, characterized in that: The balloon dilatation catheter further comprises a developing mark (4), wherein the developing mark (4) is a developing element arranged on the outer wall of the inner tube (21), or the inner tube (21) is formed with the developing mark (4).

10. The balloon dilatation catheter according to any one of claims 1 to 9, characterized in that: The balloon dilatation catheter is an intracranial angiography balloon dilatation catheter.

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