Calcified dissection balloon and balloon catheter

Abstract

The utility model provides a kind of calcification fragmentation balloon, including balloon body, the outer surface of balloon body is provided with several stress protrusions, stress protrusion is hemispheroid and is made of metal, several stress protrusions are in the outer surface of balloon body spiral type distribution, its pitch P is 1mm-2mm, the structure of this calcification fragmentation balloon is simple and can effectively expand calcification lesion in blood vessel, better through sex, reduce the risk of vascular injury and thrombosis;The utility model further provides a kind of balloon catheter, which does not need to be connected with active equipment, is easy to operate, and can reduce the cost of operation.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a calcified fragmentation balloon and balloon catheter. Background Technology

[0002] Coronary artery disease is usually caused by narrowing of blood vessels. Currently, endovascular interventional treatment usually uses balloon dilation. However, narrowing of blood vessels is often accompanied by calcification, which makes it impossible for ordinary balloon catheters to dilate effectively.

[0003] In existing technologies, the following treatment methods are commonly used to treat intravascular calcified stenosis: (1) Cutting balloon: The calcified plaque is cut by the blade on the balloon, making it easier for the balloon to dilate blood vessels and improve vascular stenosis.

[0004] (2) Rotary atherectomy: This technique uses a high-speed rotating atherectomy head to grind up calcified plaques. It is suitable for severe calcified lesions.

[0005] (3) Shockwave balloon: The shockwave balloon applies extracorporeal shock wave lithotripsy technology to blood vessels. The device that generates shock waves is delivered to the calcified lesion site of the blood vessel through a balloon catheter, and then releases high-energy shock waves. These shock waves can act on calcified plaques and use their powerful energy to cause micro-rupture of calcifications, thereby improving the compliance of blood vessels and facilitating subsequent balloon dilation and stent implantation, while reducing damage to the blood vessel wall.

[0006] However, all of the above treatment methods have certain drawbacks. Cutting balloons have shortcomings such as poor permeability and limited cutting efficiency, and are prone to complications such as vascular damage and thrombosis. Rotational atherectomy is prone to problems such as micro-damage to the vascular wall and distal vascular embolism. Shockwave balloons have disadvantages such as high technical operation requirements, limited applicability, and high price. Utility Model Content

[0007] The purpose of this invention is to provide a calcification fragmentation balloon and balloon catheter, which aims to solve or at least partially solve the shortcomings of the above-mentioned background technology. Its structure is simple and can effectively dilate calcified lesions in blood vessels. It not only has good passability and reduces the risk of vascular damage and thrombosis, but also does not require connection to active equipment, is easy to operate, and reduces surgical costs.

[0008] This invention provides a calcification fragmentation balloon, including a balloon body. The outer surface of the balloon body is provided with several stress protrusions. The stress protrusions are hemispherical and made of metal. The stress protrusions are spirally distributed on the outer surface of the balloon body, and the pitch P is 1mm-2mm.

[0009] Optionally, the distance L between two adjacent stress protrusions is 0.1mm-0.5mm.

[0010] Optionally, the diameter D of the stress protrusion is 0.1 mm to 0.5 mm.

[0011] Alternatively, the stress protrusions may be made of stainless steel, hard alloy, or cobalt-chromium alloy.

[0012] Optionally, stress protrusions are bonded to the outer surface of the balloon body.

[0013] Optionally, the nominal diameter of the balloon body is 1mm-14mm.

[0014] Optionally, the balloon body is made of an elastomeric material, including but not limited to nylon and Pebax.

[0015] Optionally, the balloon body has a straight segment, a proximal conical segment, and a distal conical segment, with the proximal and distal conical segments located at opposite ends of the straight segment. The straight segment is cylindrical, and stress protrusions are provided on the straight segment.

[0016] This utility model also provides a balloon catheter, including a catheter body, a stress diffusion tube, a catheter connector, and the aforementioned calcified fragmented balloon. The balloon body is connected to the catheter body and located at the distal end of the catheter body. The proximal end of the catheter body is connected to the stress diffusion tube. The distal end of the catheter connector is connected to the stress diffusion tube. The proximal end of the catheter connector is connected to a pressurization device.

[0017] Optionally, the distal end of the catheter body has a catheter tip, which is connected to the distal conical segment of the balloon body.

[0018] The calcification fragmentation balloon provided by this invention, by setting the stress protrusions as metal hemispheres, has two advantages. First, the surface of the stress protrusions is smooth and the contact area with the calcified lesion is extremely small. According to the Hertzian contact stress principle, the stress protrusions can act on the calcified lesion, causing it to deform and crack. Second, the smooth surface of the stress protrusions can improve the permeability of the calcification fragmentation balloon in blood vessels and reduce the risk of vascular injury. By distributing several stress protrusions in a spiral shape on the outer surface of the balloon body, the calcified lesion can be made to produce spiral cracks. Thus, the calcified lesion is no longer a circumferential whole. When the balloon body expands, the cracks of the calcified lesion expand spirally, and the calcified plaque is not easy to fall off, reducing the risk of thrombosis. This allows the calcification fragmentation balloon to effectively dilate the calcified lesion and blood vessels. In addition, the calcification fragmentation balloon has a simple structure. When applied to balloon catheters, it does not require connection to active devices, making operation simple and reducing surgical costs. Attached Figure Description

[0019] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of a calcified fragmentation balloon according to the present invention.

[0021] Figure 2 for Figure 1 A magnified diagram of point A in the middle.

[0022] Figure 3 for Figure 1 The diagram shows a three-dimensional view of the stress protrusion.

[0023] Figure 4 This is a schematic diagram of a balloon catheter according to the present invention.

[0024] The attached diagram lists the components represented by each number as follows: 10. Calcified fragmented balloon; 11. Balloon body; 111. Straight segment; 112. Proximal conical segment; 113. Distal conical segment; 12. Stress protrusion; 20. Catheter body; 21. Catheter tip; 30. Stress diffusion tube; 40. Catheter connector. Detailed Implementation

[0025] The specific embodiments of this utility model will now be described in detail with reference to the accompanying drawings. Obviously, the described embodiments are merely some, not all, of the embodiments of this utility model. Based on the description of this utility model, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this utility model.

[0026] Unless otherwise explicitly specified and limited, the terms "setup," "installation," and "connection" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium. Those skilled in the art can understand the specific meaning of these terms based on the specific circumstances.

[0027] The terms “upper,” “lower,” “left,” “right,” “front,” “back,” “top,” “bottom,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are used only for the convenience of description and simplification, 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 this utility model.

[0028] The terms “first,” “second,” “third,” etc., are used merely to distinguish elements with similar attributes, not to indicate or imply relative importance or a specific order.

[0029] The terms “include,” “comprising,” or any other variation thereof are intended to cover non-exclusive inclusion, which includes not only the elements listed but also other elements not expressly listed.

[0030] Please see Figure 1 A calcified fragmentation balloon 10 includes a balloon body 11, the outer surface of which is provided with several stress protrusions 12, the stress protrusions 12 being hemispherical and made of metal.

[0031] Several stress protrusions 12 are spirally distributed on the outer surface of the balloon body 11, with a pitch P of 1mm-2mm. It is understood that if the pitch P is too large, the calcification fragmentation effect of the calcification fragmentation balloon 10 will be significantly reduced, preventing the calcified lesion from developing spiral cracks and thus insufficient to expand the calcified lesion. If the pitch P is too small, the number of stress protrusions 12 used will increase, significantly increasing production costs. Moreover, as the pitch P further decreases, the enhancement of the calcification fragmentation effect of the calcification fragmentation balloon 10 is not significant. Through multiple experiments, it is preferred that the pitch P be controlled within the range of 1mm-2mm, which can accommodate both the requirements of calcification fragmentation effect and production cost. Those skilled in the art can specifically set the pitch P to 1mm, 1.25mm, 1.5mm, 1.75mm, 2mm, etc., and no unique limitation is made here.

[0032] As described above, the calcification fragmentation balloon 10 provided by this utility model, by setting the stress protrusions 12 as metal hemispheres, has the following advantages: Firstly, the surface of the stress protrusions 12 is smooth and the contact area with the calcified lesion is extremely small. According to the Hertzian contact stress principle, the stress protrusions 12 can act on the calcified lesion, causing it to deform and generate cracks. Secondly, the smooth surface of the stress protrusions 12 can improve the permeability of the calcification fragmentation balloon 10 in blood vessels and reduce the risk of vascular damage. By distributing several stress protrusions 12 in a spiral shape on the outer surface of the balloon body 11, the calcified lesion can generate spiral cracks. Thus, the calcified lesion is no longer a circumferential whole. When the balloon body 11 expands, the cracks of the calcified lesion expand in a spiral shape, and the calcified plaque is not easy to fall off, reducing the risk of thrombosis. This allows the calcification fragmentation balloon 10 to effectively dilate the calcified lesion and blood vessels. In addition, the calcification fragmentation balloon 10 has a simple structure. When applied to balloon catheters, it does not require connection to active devices, making operation simple and reducing surgical costs.

[0033] Furthermore, please refer to Figure 2 The distance L between two adjacent stress protrusions 12 is 0.1mm-0.5mm. It is understood that if the distance L is too large, the calcification fragmentation effect of the calcification fragmentation balloon 10 will be greatly reduced, resulting in the inability to generate continuous cracks in the calcified lesion, which is insufficient to expand the calcified lesion. If the distance L is too small, the number of stress protrusions 12 used will increase, greatly increasing production costs. Moreover, as the distance L further decreases, the enhancement of the calcification fragmentation effect of the calcification fragmentation balloon 10 is not significant. Through multiple experiments, it is preferred that the distance L be controlled within the range of 0.1mm-0.5mm, which can accommodate both the requirements of calcification fragmentation effect and production cost. Those skilled in the art can specifically set the distance L to 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, etc., and no single limitation is made here.

[0034] Furthermore, please refer to Figure 3 The diameter D of the stress protrusion 12 is 0.1mm-0.5mm. It is understood that if the diameter D is too large, it will affect the overall size of the calcified fragmentation balloon 10, resulting in poorer passage; if the diameter D is too small, it will increase the difficulty of manufacturing the stress protrusion 12, or even make it impossible to manufacture, greatly increasing production costs. Through multiple experiments, it is preferred that the diameter D be controlled within the range of 0.1mm-0.5mm, which can accommodate both the passage requirements and production cost requirements of the calcified fragmentation balloon 10. Those skilled in the art can specifically set the diameter D to 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, etc., and no single limitation is made here.

[0035] Furthermore, the stress protrusion 12 is made of stainless steel, hard alloy, or cobalt-chromium alloy.

[0036] Furthermore, the stress protrusions 12 are bonded to the outer surface of the balloon body 11 with biocompatible adhesive.

[0037] Furthermore, the nominal diameter of the balloon body 11 is 1mm-14mm.

[0038] Furthermore, the balloon body 11 is made of an elastomeric material, including but not limited to nylon and Pebax.

[0039] Furthermore, please refer to Figure 1 The balloon body 11 has a straight segment 111, a proximal conical segment 112, and a distal conical segment 113. The proximal conical segment 112 and the distal conical segment 113 are located at opposite ends of the straight segment 111, respectively. The proximal conical segment 112 and the distal conical segment 113 can improve the permeability of the calcified fragmented balloon 10 in blood vessels. The straight segment 111 is cylindrical, and stress protrusions 12 are provided on the straight segment 111.

[0040] Additionally, please see Figure 4 The present invention also provides a balloon catheter, including a catheter body 20, a stress diffusion tube 30, a catheter connector 40, and the calcified fragmentation balloon 10 in the above embodiments. The balloon body 11 is connected to the catheter body 20 and is located at the distal end of the catheter body 20. The proximal end of the catheter body 20 is connected to the stress diffusion tube 30. The distal end of the catheter connector 40 is connected to the stress diffusion tube 30. The proximal end of the catheter connector 40 is connected to a pressurization device (not shown).

[0041] Furthermore, the distal end of the catheter body 20 has a catheter tip 21, which is connected to the distal conical segment 113 of the balloon body 11. The catheter tip 21 is responsible for guiding the catheter body 20 through the calcified lesion area.

[0042] The working principle of the calcified fragmentation balloon provided by this utility model: When the calcification fragmentation balloon 10 reaches the calcified lesion, it is inflated to 5 atm-10 atm by the inflator connected to the catheter connector 40. The balloon body 11 will expand under certain pressure, and the stress protrusions 12 will come into contact with the calcified lesion. According to the Hertzian contact stress principle, the calcified lesion in contact with the stress protrusions 12 will develop cracks. Since several stress protrusions 12 are spirally distributed on the outer surface of the balloon body 11, the calcified lesion will develop spiral cracks. At this time, the calcified lesion is no longer a circumferential whole. The calcification fragmentation balloon 10 can expand the calcified lesion, thereby dilating the blood vessel.

[0043] The above description is merely a specific embodiment of this utility model, but the protection scope of this utility model is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this utility model should be included within the protection scope of this utility model. Therefore, the protection scope of this utility model should be determined by the protection scope of the claims.

Claims

1. A calcification fracturing balloon comprising a balloon body (11), characterized in that, The outer surface of the balloon body (11) is provided with several stress protrusions (12). The stress protrusions (12) are hemispherical and made of metal. The stress protrusions (12) are spirally distributed on the outer surface of the balloon body (11) with a pitch P of 1mm-2mm.

2. The calcification busting balloon of claim 1, wherein, The distance L between two adjacent stress protrusions (12) is 0.1 mm to 0.5 mm.

3. The calcification busting balloon of claim 1, wherein, The diameter D of the stress protrusion (12) is 0.1mm-0.5mm.

4. The calcification busting balloon of claim 1, wherein, The stress protrusion (12) is made of stainless steel, hard alloy or cobalt-chromium alloy.

5. The calcific-fragmentation balloon of claim 1, wherein, The stress protrusion (12) is bonded to the outer surface of the balloon body (11).

6. The calcific crumbler balloon of claim 1, wherein, The nominal diameter of the balloon body (11) is 1mm-14mm.

7. The calcific crumbler balloon of claim 1, wherein, The balloon capsule (11) is made of an elastomeric material, including but not limited to nylon and Pebax.

8. The calcific crumbler balloon of claim 1, wherein, The balloon body (11) has a straight section (111), a proximal conical section (112) and a distal conical section (113), the proximal conical section (112) and the distal conical section (113) are located at both ends of the straight section (111), the straight section (111) is cylindrical, and the stress protrusion (12) is provided on the straight section (111).

9. A balloon catheter characterized by, The device includes a catheter body (20), a stress diffusion tube (30), a catheter connector (40), and a calcification fragmentation balloon (10) as described in any one of claims 1-8. The balloon body (11) is connected to the catheter body (20) and located at the distal end of the catheter body (20). The proximal end of the catheter body (20) is connected to the stress diffusion tube (30). The distal end of the catheter connector (40) is connected to the stress diffusion tube (30). The proximal end of the catheter connector (40) is connected to a pressurization device.

10. The balloon catheter of claim 9, wherein, The distal end of the catheter body (20) has a catheter tip (21) which is connected to the distal conical segment (113) of the balloon body (11).

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