Spinous process type micro-injection balloon suitable for hemodialysis internal arteriovenous fistula stenosis treatment

Abstract

The invention relates to a spinous process type micro-injection balloon suitable for hemodialysis internal arteriovenous fistula stenosis treatment, and the balloon adopted by the invention has a double-layer structure which is a layered balloon cavity structure and is provided with an inner layer and an outer layer. And the inner layer is used for injecting liquid so as to expand and support the internal balloon. A space is reserved between the outer balloon and the inner balloon and serves as a medicine cabin, and the anti-proliferation medicine is pre-filled in the space in a liquid state or a jelly state. The outer surface of the outer balloon is provided with a plurality of spinous process micro-injection heads with certain hardness, the spinous process micro-injection heads protrude and pierce into the deep layer of the blood vessel wall when the balloon is pressurized, after the balloon is expanded and pressurized to a certain degree, the spinous process micro-injection heads are expanded and exploded to form openings, and medicine is injected into the blood vessel wall; the drugs injected into the deep layer of the blood vessel can be in contact with cells in the deep layer and the superficial layer of the blood vessel wall through diffusion, proliferation of the cells is inhibited, thickening of the blood vessel wall is reduced, and relapse of vascular stenosis is reduced.

Description

Technical Field

[0001] The present disclosure relates to the technical field of clinical medical devices, and particularly to a spine-type micro-injection balloon applicable to the treatment of arteriovenous fistula stenosis in hemodialysis. Background Art

[0002] Currently, the treatment of arteriovenous fistula stenosis in hemodialysis mainly relies on balloon dilation. In addition to ordinary balloons, drug-coated balloons are emerging in recent years. As shown in the figure, drugs are coated on the surface of the balloon. When dilating, the drugs on the surface of the balloon penetrate into the blood vessel wall, and these drugs can play a role in inhibiting the proliferation of cells in the wall, thereby reducing the probability of restenosis. Figure 1 However, the conclusions drawn from clinical studies are inconsistent. Some studies believe that the balloon is effective, while others believe that the effect is not obvious. Among them, the main reasons for the poor effect are as follows: Due to the stenosis part of the arteriovenous fistula, intimal hyperplasia, smooth muscle thickening, and the structure is relatively dense, the depth of drug penetration is limited, that is, the position of the blood vessel wall reached by the drug is too superficial to inhibit the proliferation of deep cells.

[0003] Therefore, it is necessary to inject drugs into the deep layer of blood vessels. These drugs mainly inhibit proliferation, reduce blood vessel wall thickening, and reduce blood vessel stenosis. However, the existing drug-coated balloons cannot achieve this deep blood vessel wall inhibition effect, so further optimization and upgrading are needed.

[0004] Summary of the Invention

[0005] To solve the above problems, the present application proposes a spine-type micro-injection balloon applicable to the treatment of arteriovenous fistula stenosis in hemodialysis.

[0006] The present application proposes a spine-type micro-injection balloon applicable to the treatment of arteriovenous fistula stenosis in hemodialysis, which is used based on the detected blood pressure of the arteriovenous fistula in hemodialysis. The balloon includes a push rod and a balloon, wherein:

[0007] The balloon is a layered cavity structure, and an anti-proliferation drug for inhibiting the proliferation of cells in the blood vessel wall is stored therein;

[0008] The layered cavity structure is provided with spine micro-injection heads that can be in non-planar contact with the blood vessel wall, and the spine micro-injection heads are used to release the anti-proliferation drug to the blood vessel wall when the balloon expands to a preset bursting pressure.

[0009] As an optional implementation scheme of the present application, optionally, the layered cavity structure includes:

[0010] An inner balloon, which is arranged on the push rod and is used for pressurized expansion and supporting the outer balloon;

[0011] An outer balloon, disposed outside the inner balloon, for forming a drug cavity for storing the anti-proliferative drug between the outer balloon and the inner balloon;

[0012] The anti-proliferative drug is pre-filled in the outer balloon in a liquid or gel state;

[0013] The spinous micro-injection head is disposed on the surface of the outer balloon.

[0014] As an alternative embodiment of the present application, optionally, the liquid storage capacity of the drug cavity is: 0.5 - 5.5 ml.

[0015] As an alternative embodiment of the present application, optionally, the spinous micro-injection heads are arranged in an array and are equidistantly disposed on the surface of the outer balloon, and the spacing is: 0.10 - 2.00 mm.

[0016] As an alternative embodiment of the present application, optionally, the spinous micro-injection head is a papillary structure, and the hardness of the POC, PE, PET, PA or TPU material used is as follows:

[0017] Shore A (spinous micro-injection head) ≥ (1.2 - 1.5) Shore A (balloon),

[0018] Shore A represents the hardness of a medical POC, PE, PET, PA or TPU balloon.

[0019] As an alternative embodiment of the present application, optionally, the interior of the spinous micro-injection head is hollow and forms a temporary liquid storage chamber;

[0020] After the outer balloon is inflated by the inner balloon, the anti-proliferative drug enters the temporary liquid storage chamber.

[0021] As an alternative embodiment of the present application, optionally, the head of the spinous micro-injection head is a bursting film, and the bursting pressure it can withstand is: 5 - 15 atm; the bursting pressure of the inner / outer balloon is 20 - 30 atm;

[0022] When the bursting film is squeezed and inflated by the outer balloon and reaches the bursting pressure it can withstand, the bursting film ruptures and releases the anti-proliferative drug.

[0023] As an alternative embodiment of the present application, optionally, the anti-proliferative drug is paclitaxel.

[0024] The technical effects of the present invention:

[0025] The balloon used in the balloon of the present invention has a double-layer structure, which is a layered cavity structure with an inner layer and an outer layer. The inner layer is used to inject air or liquid to expand and support the outer balloon. There is a space between the outer balloon and the inner balloon as a drug compartment, and a sustained-release drug is injected into it in advance. On the outer surface of the outer balloon, a number of spine micro-injection heads are provided (also made of POC, PE, PET, PA or TPU materials, but the material hardness is higher than that of the balloon to facilitate protruding and piercing into the blood vessel wall). After the balloon expands, each spine micro-injection head can burst open by squeezing the drug (with a certain pressure) to inject the drug into the blood vessel wall and inject the drug deep into the blood vessel. These drugs mainly inhibit hyperplasia, reduce blood vessel wall thickening, and reduce blood vessel stenosis.

[0026] Other features and aspects of the present disclosure will become apparent from the following detailed description of exemplary embodiments with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The drawings included in and constituting a part of this specification, together with the specification, illustrate exemplary embodiments, features, and aspects of the present disclosure and are used to explain the principles of the present disclosure.

[0028] Figure 1 Shown is a schematic diagram of the application structure of an existing balloon;

[0029] Figure 2 Shown is a schematic diagram of the support of an existing balloon in a blood vessel;

[0030] Figure 3 Shown is a schematic diagram of the composition structure of the balloon of the present invention (cross-sectional view);

[0031] Figure 4 Shown is a schematic cross-sectional structure diagram of the spine micro-injection head of the present invention;

[0032] Figure 5 Shown is a schematic diagram of the spine micro-injection head bursting open to release the drug of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0033] Various exemplary embodiments, features, and aspects of the present disclosure will be described in detail below with reference to the accompanying drawings. The same reference numerals in the drawings denote elements having the same or similar functions. Although various aspects of the embodiments are shown in the drawings, the drawings are not necessarily drawn to scale unless otherwise specified.

[0034] The special word "exemplary" herein means "serving as an example, embodiment, or illustration". Any embodiment described herein as "exemplary" is not necessarily to be construed as superior to or better than other embodiments.

[0035] In addition, for a better illustration of the present disclosure, numerous specific details are provided in the following detailed implementation manners. Those skilled in the art should understand that the present disclosure can also be implemented without certain specific details. In some instances, means, elements, and circuits well-known to those skilled in the art are not described in detail to highlight the gist of the present disclosure.

[0036] The balloon sustained-release technology can effectively inhibit the proliferation of vascular wall cells by controlling the drug release rate. In the drug formulation, the balloon sustained-release technology can extend the action time of the drug in the blood vessel, reduce the systemic side effects of the drug, and improve the treatment effect at the same time.

[0037] In this embodiment, it mainly aims to inhibit the proliferation of cells on the vascular wall where the arteriovenous fistula for hemodialysis is located. The inhibitory liquid medicine is sent to the vascular wall of the arteriovenous fistula for hemodialysis by using a balloon and sustained-release is carried out.

[0038] Compared with the coated balloon, the balloon of the present invention can store the liquid medicine for a long time, avoiding drug loss caused by the friction between the drug and the vascular wall or blood dilution during the transportation process.

[0039] As Figure 3 shown, the present application proposes a spine-type micro-injection balloon applicable to the treatment of stenosis of arteriovenous fistulas for hemodialysis, which is used based on the detected blood pressure of arteriovenous fistulas for hemodialysis. The balloon includes a push rod 1 and a balloon 2, wherein:

[0040] The balloon 2 is a layered cavity structure, which stores an anti-proliferation drug for inhibiting the proliferation of cells in the vascular wall; it is mainly divided into an inner balloon and an outer balloon. The inner balloon provides support and the outer balloon stores the anti-proliferation drug. The anti-proliferation drug is pre-filled in the outer balloon in a liquid or jelly state.

[0041] The layered cavity structure is provided with spine micro-injection heads 3 that can be in non-planar contact with the vascular wall. The spine micro-injection heads are used to release the anti-proliferation drug to the vascular wall when the balloon expands to reach a preset bursting pressure.

[0042] Generally, a balloon has a push rod and a balloon. The balloon is pushed to the corresponding target position by the push rod, and the balloon is inflated by blowing air or injecting liquid through the push rod to make the balloon fit the inner wall of the blood vessel (see the description principle of the prior art for details).

[0043] Traditional balloons use the drug coating on the balloon to fit the vascular wall, so that the drug can be back-fed and penetrate into the vascular wall to inhibit the proliferation of vascular cells.

[0044] The balloon used in the present invention has a double-layer structure, which is a layered cavity structure with an inner layer and an outer layer. The inner layer is used to inject air or liquid to expand and support the outer balloon. There is a space between the outer balloon and the inner balloon as a drug chamber, and a sustained-release drug is injected into it in advance. On the outer surface of the outer balloon, several spine micro-injection heads (also made of POC, PE, PET, PA or TPU materials, but the material hardness is higher than that of the balloon, which is convenient for protruding and piercing into the blood vessel wall) are provided. Each spine micro-injection head can pierce into the deep layer of the blood vessel wall after the balloon expands, and the drug (with a certain pressure) is used to burst and explode the spine micro-injection head by extrusion, so as to inject the drug into the blood vessel wall and inject the drug into the deep layer of the blood vessel. These drugs mainly inhibit proliferation, reduce blood vessel wall thickening, and reduce blood vessel stenosis.

[0045] Through the balloon of the present invention, it is possible to avoid drug loss caused by being diluted by blood or scraped by the blood vessel wall during the process of transporting the balloon to the target position. After reaching the target position, the balloon stent can be expanded, and the drug can be reflected to the blood vessel wall by the explosion of the spine micro-injection head, enabling targeted treatment, avoiding drug loss, and improving the treatment effect of the balloon.

[0046] The present invention needs to be used in combination with the detected blood pressure of the arteriovenous fistula for hemodialysis. If it is detected that the blood pressure of the arteriovenous fistula for hemodialysis increases to a certain value (such as exceeding 105 - 130 mmHg), then it is used, and specifically, it is used by a clinician according to the patient's condition.

[0047] As an optional implementation scheme of the present application, optionally, the layered cavity structure includes:

[0048] The inner balloon 202 is arranged on the push rod and is used for pressurized expansion and support of the outer balloon;

[0049] The outer balloon 201 is arranged outside the inner balloon and is used to form a drug cavity for storing the anti-proliferation drug between it and the inner balloon;

[0050] The spine micro-injection head is arranged on the surface of the outer balloon.

[0051] Combined with the attached Figure 3 As shown, the balloon is divided into two layers:

[0052] The cavity inside the inner layer is a pressurized cavity, which is the same as a general balloon;

[0053] Between the outer layer and the inner layer is a drug chamber for storing the liquid medicine to be perfused, such as paclitaxel. There are many papillary protrusions on the surface of the outer balloon, serving as "spine micro-injection heads" for drug injection. These spine micro-injection heads have a certain hardness and height. The tip of the spine micro-injection head is closed, and the material of the closed tip has the property of bursting when reaching a certain pressure, that is, when the internal pressure of the balloon rises to a certain level and these protrusions are embedded in the blood vessel wall, the top ruptures, and the drug is released and enters the blood vessel wall. Because of the protrusions of the spine micro-injection heads, they can penetrate into the blood vessel wall after the balloon expands and supports. Compared with ordinary drug-coated balloons, they can reach deeper into the blood vessel wall and have a wider range of inhibiting hyperplasia.

[0054] The balloon material is such as POC, PE, PET, PA or TPU, and the thickness and size are not limited.

[0055] The spine micro-injection heads are made of POC, PE, PET, PA or TPU materials with a hardness greater than that of the balloon and are compounded (such as by hot melt pasting) with the balloon.

[0056] As an optional implementation scheme of the present application, optionally, the liquid storage capacity of the drug chamber is: 0.5 - 5.5 ml.

[0057] The liquid storage capacity of the drug chamber can be adjusted according to requirements.

[0058] As an optional implementation scheme of the present application, optionally, the spine micro-injection heads are arranged in an array and are equally spaced on the surface of the outer balloon, and the spacing is: 0.10 - 2.00 mm.

[0059] The spine micro-injection heads are distributed on the surface of the outer balloon and need to maintain a certain spacing, and a spacing of 0.10 - 2.00 mm is sufficient.

[0060] As an optional implementation scheme of the present application, optionally, the spine micro-injection head 3 is a papillary structure, and the hardness of the POC, PE, PET, PA or TPU material used is as follows:

[0061] Shore A (spine micro-injection head) ≥ (1.2 - 1.5) Shore A (balloon),

[0062] Shore A represents the hardness of medical POC, PE, PET, PA or TPU balloons.

[0063] Specifically, according to the hardness of the POC, PE, PET, PA or TPU material selected for the balloon stent, the POC, PE, PET, PA or TPU material of the spine micro-injection head with a corresponding range of hardness is selected.

[0064] Medical POC, PE, PET, PA or TPU balloons usually use Shore A hardness to represent their hardness characteristics. The higher the hardness value, the greater the stiffness of the product. The hardness value is generally selected between 20 and 80. Different medical applications require POC, PE, PET, PA or TPU balloons with different hardnesses, and POC, PE, PET, PA or TPU balloons with different hardnesses are needed.

[0065] In this embodiment, if the spinous process micro-injection head and the balloon stent are made of the same material, they can be made into structures with different thicknesses. The thickness of the spinous process micro-injection head should be greater than that of the balloon stent, so as to have higher hardness in use. If the spinous process micro-injection head and the balloon stent are made of different materials, the spinous process micro-injection head needs to be made of a material with a hardness higher than that of the balloon stent.

[0066] Regarding the specific balloon manufacturing process, this embodiment will not be elaborated. It only needs to meet that the hardness of the spinous process micro-injection head is higher than that of the stent balloon; and meet: before being delivered to the target position, it remains in a contracted state; when it is delivered to the target position and the stent balloon expands, prompting the outer balloon to expand, and the liquid fills the spinous process micro-injection head to the explosive state.

[0067] As Figure 4 shown, as an alternative implementation of the present application, optionally, the inside of the spinous process micro-injection head 3 is hollow and forms a temporary liquid storage chamber 301;

[0068] After the outer balloon is expanded by the inner balloon, the anti-proliferation drug enters the temporary liquid storage chamber.

[0069] The spinous process micro-injection head 3 lies flat or contracts when the balloon is not pressurized, and stands up or protrudes after pressurization.

[0070] Combined with the pressurized expansion state shown in the attached Figure 5 figure, it can be seen that the spinous process micro-injection head 3 protrudes after the balloon is pressurized. When the bursting pressure that the head can withstand is reached, it will burst and release drug molecules.

[0071] As Figure 5 shown, as an alternative implementation of the present application, optionally, the head of the spinous process micro-injection head 3 is a bursting film 302, and the bursting pressure it can withstand is: 5 - 15 atm; the bursting pressure of the inner / outer balloon is 20 - 30 atm;

[0072] When the bursting film is squeezed and expanded by the outer balloon and reaches the bursting pressure it can withstand, the bursting film ruptures and releases the anti-proliferation drug.

[0073] The bursting pressure that the balloon body can withstand should be 1-3 times that of the bursting film. It is necessary to ensure that when the bursting film opens, the body balloon is in a safe state. The bursting opening is 0.5-2 mm.

[0074] The bursting film 302 is a balloon-expandable valve (valve), with at least 3 symmetrically arranged in the center and capable of sealing and anastomosing.

[0075] Each spine micro-injection head is a papillary structure, and its head is a bursting film composed of several valves (a structure similar to the aortic valve that can explode when a certain pressure is reached). Inside the spine micro-injection head, when the anti-proliferative drug is not filled, the valves close to form a sealed chamber; after the balloon is inflated with gas or liquid, the anti-proliferative drug will enter the inside of the spine micro-injection head. When the balloon continues to be inflated with liquid or gas, the liquid medicine generates a continuously increasing hydraulic pressure inside the spine micro-injection head. When the limit bursting pressure that the bursting film can withstand is reached, the valves open, the drug is released, contacts the vascular wall tissue cells, and the drug contacts and reflects into the cells to inhibit cell proliferation, etc. In the present invention, the valves at the top of the spine micro-injection head can adopt an integrated structure.

[0076] As an alternative implementation of this application, optionally, the anti-proliferative drug is paclitaxel.

[0077] When the balloon of the present invention is used, if it is found that the stenosis site of the arteriovenous fistula is a superficial site, a drug coating can also be added to the surface of the balloon. For specific reference, see the application of existing balloons.

[0078] It should be noted that although the above balloon sustained-release liquid is introduced by taking paclitaxel as an example, those skilled in the art can understand that the present disclosure should not be limited to this. In fact, users can flexibly set the sustained-release liquid according to the actual application scenario (such as docetaxel, fluorouracil, platinum drugs, doxorubicin, gefitinib, erlotinib, etc.), as long as the technical functions of this application can be achieved according to the above technology.

[0079] The above has described the embodiments of the present disclosure. The above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes are obvious to those of ordinary skill in the art in the technical field without departing from the scope and spirit of the described embodiments. The selection of the terms used herein is intended to best explain the principles of the embodiments, the actual application, or the improvement of the technology in the market, or to enable other ordinary skill in the art in the technical field to understand the embodiments disclosed herein.

Claims

1. A spinous process microinjection balloon suitable for treating arteriovenous fistula stenosis in hemodialysis, characterized in that: The balloon comprises a push rod and a balloon, wherein: The balloon is a layered cavity structure, in which anti-proliferation drugs for inhibiting cell proliferation in the blood vessel wall are stored; The layered balloon cavity structure is provided with a spinous process microinjection head that can make non-planar contact with the blood vessel wall. The spinous process microinjection head is used to release the anti-proliferation drug to the blood vessel wall when the balloon expands to a preset bursting pressure.

2. The spinous process microinjection balloon suitable for treating hemodialysis arteriovenous fistula stenosis according to claim 1, characterized in that: The layered cystic cavity structure comprises: An inner balloon, arranged on the push rod, for pressurizing and expanding and supporting the outer balloon; An outer balloon, disposed outside the inner balloon, and used to form a drug cavity for storing the anti-proliferative drug between the outer balloon and the inner balloon; The antiproliferative drug is pre-filled in the outer balloon in a liquid or jelly state; The spinous process microinjection head is arranged on the surface of the outer balloon.

3. The spinous process microinjection balloon suitable for treating hemodialysis arteriovenous fistula stenosis according to claim 2, characterized in that: The liquid storage capacity of the medicine chamber is 0.5-5.5 ml.

4. The spinous process microinjection balloon suitable for treating hemodialysis arteriovenous fistula stenosis according to claim 2, characterized in that: The spinous process microinjection heads are arranged in an array manner and are arranged on the surface of the outer balloon at equal intervals, with a spacing of 0.10-2.00 mm.

5. The spinous process microinjection balloon suitable for treating hemodialysis arteriovenous fistula stenosis according to claim 2, characterized in that: The spinous process microinjection head is a nipple-shaped structure, and the hardness of the POC, PE, PET, PA or TPU material used is as follows: Shore A (spinous process microinjection head) ≥ (1.2-1.5) Shore A (balloon), Shore A indicates the hardness of medical POC, PE, PET, PA or TPU balloons.

6. The spinous process microinjection balloon suitable for treating hemodialysis arteriovenous fistula stenosis according to claim 5, characterized in that: The spinous process microinjection head is hollow inside and forms a temporary liquid storage tank; After the outer balloon is inflated by the inner balloon, the anti-proliferative drug enters the temporary liquid storage tank.

7. The spinous process microinjection balloon suitable for treating hemodialysis arteriovenous fistula stenosis according to claim 6, characterized in that: The head of the spinous process microinjection head is an explosive film, which can withstand a bursting pressure of 5-15atm; the bursting pressure of the inner / outer balloon is 20-30atm; When the bursting membrane is squeezed and expanded by the outer balloon and reaches a bursting pressure that it can withstand, the bursting membrane ruptures to release the anti-proliferation drug.

8. The spinous process microinjection balloon suitable for treating hemodialysis arteriovenous fistula stenosis according to claim 7, characterized in that: The antiproliferative drug is paclitaxel.

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