A bull-nose balloon and balloon dilatation catheter

Abstract

The present application relates to the technical field of medical devices, and provides a papillary balloon and a balloon dilatation catheter, the papillary balloon comprising: a balloon body; a papillary structure arranged on the outer surface of the balloon body; the papillary structure comprising a papillary point and an inner support, the inner support being at least partially arranged in the papillary point, and the end of the inner support away from the balloon body being a sharp part; after the balloon body is inflated, the sharp part of the inner support is in an external leakage state and is used for piercing into a lesion tissue. The papillary balloon, the papillary structure comprising the papillary point and the inner support, and the inner support being at least partially arranged in the papillary point, can increase the hardness and strength of the papillary point; in addition, the end of the inner support away from the balloon body is a sharp part, in use, the balloon body is delivered to a lesion area, and after the balloon body is inflated, the sharp part pierces into the lesion tissue. In this way, the balloon body can not only prevent sliding, but also cut the lesion tissue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a mastoid balloon and a balloon dilation catheter. Background Technology

[0002] For many years, arterial blockage has been a major medical problem. This is because arterial blockage reduces blood flow through the arteries, leading to various serious complications. Arterial stenosis is mainly caused by the deposition of cholesterol, calcium, and fibrotic tissue, and angioplasty is perhaps the most common treatment for this condition. The angioplasty procedure involves using an inflatable balloon to dilate the blocked artery. Existing balloons are basically smooth balloon bodies. During treatment, because calcified lesions are relatively hard, they are easily squeezed out of the balloon during inflatation, causing the balloon to be squeezed into the normal blood vessel. This not only risks vascular trauma but also fails to dilate the narrowed area. To address these issues, existing technologies add protrusions to the outer surface of the balloon in hopes of reducing balloon slippage; however, the strength and rigidity of these protrusions are insufficient, and the anti-slip effect is not very good. Summary of the Invention

[0003] Therefore, the present invention aims to solve the problem in the prior art that adding protrusions to the outer surface of the balloon in order to reduce balloon slippage, but the strength and hardness of the protrusions are insufficient, and the anti-slip effect is not very good, thereby providing a mastoid balloon and balloon dilation catheter.

[0004] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0005] This invention provides a mastoid balloon, comprising: a balloon body; a mastoid structure disposed on the outer surface of the balloon body; the mastoid structure includes a mastoid point and an inner support member, the inner support member being at least partially disposed within the mastoid point, and the end of the inner support member away from the balloon body being a sharp portion; after the balloon body is inflated, the sharp portion of the inner support member is exposed and used to pierce into the lesion tissue.

[0006] Furthermore, the remaining portion of the inner support member, except for the sharp part, is enclosed by the nipple protrusion.

[0007] Furthermore, the inner support is completely enclosed within the mastoid process. After the balloon body is delivered to the lesion area and inflates, the mastoid process is compressed by the lesion tissue, and the sharp part of the inner support pierces the mastoid process and extends out from within the mastoid process.

[0008] Furthermore, the papillae are papillae made using a radiopaque material.

[0009] Furthermore, the inner support is made of metal; or, the sharp part is made of metal.

[0010] Furthermore, the inner support member is a conical structure, a blade-shaped structure, or a columnar structure; the sharp part is a pointed structure, a toothed structure, or a blade-shaped structure.

[0011] Furthermore, the mastoid balloon also includes an ultrasound device disposed within the balloon body, used to generate high-frequency vibrations in the internal support member.

[0012] Furthermore, the outer surface of the balloon body is provided with a plurality of papillary structures, and two adjacent papillary structures are staggered from each other along the circumferential direction of the balloon body.

[0013] The present invention also provides a balloon dilation catheter, comprising the mastoid balloon described in any one of the above descriptions, and further comprising: a catheter and a catheter seat; the catheter comprises an inner tube and an outer tube, the inner tube passing through the interior of the outer tube and inserted into the lumen of the balloon body, wherein an inflation channel communicating with the lumen of the balloon body is formed between the inner tube and the outer tube; the distal end of the balloon body is connected to the distal end of the inner tube, and the proximal end of the balloon body is connected to the distal end of the outer tube; the proximal end of the outer tube is connected to the catheter seat.

[0014] Furthermore, the catheter hub has a first interface, a second interface, a third interface, and a fourth interface; the proximal end of the outer tube is connected to the first interface; the second interface serves as a balloon inflation port, which is connected to the inflation channel; the third interface serves as a guidewire outlet, the inner lumen of the inner tube is a guidewire lumen, and the guidewire outlet is connected to the proximal end of the inner tube; the fourth interface serves as an ultrasound interface, through which an ultrasound device is connected to external equipment.

[0015] The technical solution of this invention has the following advantages:

[0016] The mastoid balloon provided by this invention includes a mastoid structure comprising a mastoid point and an internal support member. The internal support member is at least partially disposed within the mastoid point, increasing its rigidity and strength. Furthermore, the end of the internal support member furthest from the balloon body is a sharp portion. During use, the balloon body is delivered to the lesion area, and after inflation, the sharp portion penetrates the lesion tissue. This design not only prevents the balloon body from slipping but also effectively cuts the lesion tissue. Attached Figure Description

[0017] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the mastoid balloon in an embodiment of the present invention;

[0019] Figure 2 This is a front view of the mastoid balloon in an embodiment of the present invention;

[0020] Figure 3 This is a cross-sectional view of a mastoid balloon in one embodiment of the present invention;

[0021] Figure 4 for Figure 3 Enlarged diagram of section A in the middle;

[0022] Figure 5 for Figure 4 A diagram illustrating the sharp part of the needle piercing the mastoid point;

[0023] Figure 6 This is an enlarged schematic diagram of the mastoid structure in the mastoid balloon in another embodiment of the present invention;

[0024] Figure 7 for Figure 6 A diagram illustrating the sharp part of the needle piercing the mastoid point;

[0025] Figure 8 This is an enlarged schematic diagram of the mastoid structure in the mastoid balloon in another embodiment of the present invention;

[0026] Figure 9 This is a schematic diagram of a mastoid balloon in another embodiment of the present invention.

[0027] Explanation of reference numerals in the attached figures:

[0028] 1. Balloon body; 2. Mastoid structure; 201. Mastoid point; 202. Internal support; 2021. Sharp part; 3. Ultrasonic device. Detailed Implementation

[0029] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0031] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0032] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0033] like Figure 1 , Figure 2 , Figure 3 , Figure 4 as well as Figure 5 As shown, this embodiment provides a mastoid balloon, including: a balloon body 1; a mastoid structure 2 disposed on the outer surface of the balloon body 1; the mastoid structure 2 includes a mastoid point 201 and an inner support member 202, the inner support member 202 being at least partially disposed within the mastoid point 201, and the end of the inner support member 202 away from the balloon body 1 being a sharp portion 2021; after the balloon body 1 is inflated, the sharp portion 2021 of the inner support member 202 is exposed, for piercing into the lesion tissue.

[0034] The mastoid balloon provided in this embodiment includes a mastoid structure 2 comprising a mastoid point 201 and an inner support 202. The inner support 202 is at least partially disposed within the mastoid point 201, increasing the rigidity and strength of the mastoid point 201. Furthermore, the end of the inner support 202 furthest from the balloon body 1 is a sharp portion 2021. During use, the balloon body 1 is delivered to the lesion area, and after inflation, the sharp portion 2021 penetrates the lesion tissue. This design not only prevents the balloon body 1 from slipping but also cuts the lesion tissue.

[0035] like Figure 9As shown, the inner support member 202, except for the sharp portion 2021, is entirely enclosed by the nipple protrusion 201. That is, in this embodiment, in the initial state, the root and middle portion of the inner support member 202 can be enclosed within the nipple protrusion 201, while the sharp portion 2021 at the top of the inner support member 202 is exposed outside the nipple protrusion 201.

[0036] like Figure 6 , Figure 7 As shown, the inner support member 202 is completely enclosed within the papillary point 201. After the balloon body 1 is delivered to the lesion area and inflates, the papillary point 201 is compressed by the lesion tissue, and the sharp part 2021 of the inner support member 202 pierces the papillary point 201 and protrudes from within it. That is, in this embodiment, in the initial state, the inner support member 202 is completely enclosed within the papillary point 201, and only when the balloon body 1 inflates is the sharp part 2021 exposed after piercing the top of the papillary point 201.

[0037] Multiple papillary structures 2 can be provided on the outer surface of the balloon body 1. These papillary structures 2 can be uniformly arranged in an array on the outer surface of the balloon body 1, with adjacent papillary structures 2 staggered from each other along the circumferential direction of the balloon body 1. The specific number of papillary structures 2 is not limited; for example, each balloon body 1 can have at least two rows of papillary structures 2, with at least two papillary structures 2 in each row. The spacing between the papillary structures 2 is determined by the length of the balloon body 1 and the number of papillary structures 2.

[0038] The papillae 201 are made of a developing material. For example, the papillae 201 can have a sac-like structure, with a diameter ranging from 0.2 mm to 1 mm and a height ranging from 0.05 mm to 0.50 mm. The material of the papillae 201 can be polyurethane, nylon, or polyether block polyamide, and it can be doped with materials such as barium sulfate for development. With this configuration, the papillae 201 can be used for development.

[0039] The inner support 202 is made of a metal material; or the sharp part 2021 is made of a metal material. For example, the inner support 202 can be made of stainless steel, titanium alloy, nickel-titanium alloy, or other metals. Similarly, the sharp part 2021 can be made of stainless steel, titanium alloy, nickel-titanium alloy, or other metals.

[0040] like Figure 5 , Figure 7 as well as Figure 8As shown, the inner support member 202 is a conical structure, a blade-shaped structure, or a columnar structure; for example, the diameter of the inner support member 202 can range from 0.2mm to 1mm, and the height can range from 0.05mm to 0.60mm. The sharp part 2021 is a pointed structure, a toothed structure, or a blade-shaped structure. For example, the sharp part 2021 can be a needle tip, a sharp edge, a serration, or a blade. For example, different papillary structures 2 of the sharp part 2021 can be provided on the balloon body 1.

[0041] The diameter of the balloon body 1 can range from 0.75mm to 30.0mm, and the length of the balloon body 1 can range from 5mm to 300mm.

[0042] The mastoid balloon also includes an ultrasonic transducer 3, which is disposed within the balloon body 1 to induce high-frequency vibration in the inner support member 202. For example, the distal end of the ultrasonic transducer 3 can be designed as a ring structure, which can be fitted onto the outer wall of the inner tube, while the proximal end of the ultrasonic transducer 3 can extend outward from the inflation channel and connect to external equipment. This configuration allows the inner support member 202 within the mastoid point 201 to vibrate at high frequency using ultrasonic waves, resulting in better cutting performance.

[0043] Another embodiment also provides a balloon dilation catheter, comprising the papillary balloon described in any one of the above embodiments.

[0044] The balloon dilation catheter further includes: a catheter and a catheter seat; the catheter includes an inner tube and an outer tube, the inner tube passes through the inside of the outer tube and is inserted into the lumen of the balloon body 1, and an inflation channel communicating with the lumen of the balloon body 1 is formed between the inner tube and the outer tube; the distal end of the balloon body 1 is connected to the distal end of the inner tube, and the proximal end of the balloon body 1 is connected to the distal end of the outer tube; the proximal end of the outer tube is connected to the catheter seat.

[0045] The catheter hub has a first interface, a second interface, a third interface, and a fourth interface; the proximal end of the outer tube is connected to the first interface; the second interface serves as a balloon inflation port, which is connected to the inflation channel; the third interface serves as a guidewire outlet, the inner lumen of the inner tube is a guidewire lumen, and the guidewire outlet is connected to the proximal end of the inner tube; the fourth interface serves as an ultrasound interface, and the ultrasound device is connected to external equipment through the inflation channel and the ultrasound interface.

[0046] In summary, the mastoid balloon and balloon dilation catheter in this application can not only prevent the balloon body 1 from sliding, but also cut the lesion. At the same time, the mastoid point 201 itself can be visualized.

[0047] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A papillary balloon, characterized by, It comprises: a balloon body (1); a papillary structure (2) arranged on the outer surface of the balloon body (1); the papillary structure (2) comprises papillary points (201) and inner support members (202), the inner support members (202) are arranged at least partially in the papillary points (201), and the end of the inner support members (202) away from the balloon body (1) is a sharp part (2021); after the balloon body (1) is inflated, the sharp part (2021) of the inner support member (202) is in an exposed state and is used for penetrating into a lesion tissue; the papillary point (201) is a papillary point (201) made of a developing material; it further comprises an ultrasonic device (3) arranged in the balloon body (1) and used for generating high-frequency vibration of the inner support member (202); the inner support member (202) is in a conical structure, a blade structure or a columnar structure; the sharp part (2021) is in a pointed structure, a toothed structure or a blade structure; a plurality of papillary structures (2) are arranged on the outer surface of the balloon body (1), and two adjacent papillary structures (2) along the circumferential direction of the balloon body (1) are arranged staggeredly.

2. The papillary balloon according to claim 1, wherein the rest of the inner support member (202) except the sharp part (2021) is wrapped in the papillary point (201).

3. The papillary balloon according to claim 1, wherein the inner support member (202) is wrapped in the papillary point (201) entirely, after the balloon body (1) is inflated and delivered to a lesion area, the papillary point (201) is extruded by a lesion tissue, the sharp part (2021) of the inner support member (202) pierces the papillary point (201) and extends out of the papillary point (201).

4. The papillary balloon according to claim 1, wherein the inner support member (202) is made of a metal material; or, the sharp part (2021) is made of a metal material.

5. A balloon dilatation catheter characterized by, The papillary balloon according to any one of claims 1-4 further comprises: a catheter and a catheter seat; the catheter comprises an inner tube and an outer tube, the inner tube passes through the inner part of the outer tube, and the inner tube is inserted into the inner cavity of the balloon body (1), and a filling channel is formed between the inner tube and the outer tube and is communicated with the inner cavity of the balloon body (1); the distal end of the balloon body (1) is connected with the distal end of the inner tube, and the proximal end of the balloon body (1) is connected with the distal end of the outer tube; the proximal end of the outer tube is connected with the catheter seat.

6. The balloon dilatation catheter according to claim 5, wherein the catheter seat has a first interface, a second interface, a third interface and a fourth interface; the proximal end of the outer tube is connected with the first interface; the second interface is a balloon filling port and is communicated with the filling channel; the third interface is a guide wire outlet, the inner cavity of the inner tube is a guide wire cavity, and the guide wire outlet is communicated with the proximal end of the inner tube. The fourth interface is an ultrasonic interface, and an ultrasonic device is connected to an external device through the ultrasonic interface. The fourth interface is an ultrasonic interface, and an ultrasonic device is connected to an external device through the ultrasonic interface.

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