A novel balloon catheter
By designing a novel balloon catheter, which utilizes a second balloon to expand the vessel wall and can be equipped with a cutting tool, the problem of blockage after implantation of covered stents has been solved, thereby improving blood flow and distal perfusion.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- 郭亦帆
- Filing Date
- 2025-02-08
- Publication Date
- 2026-05-29
AI Technical Summary
In existing technologies, both arterial bypass surgery and endovascular stent graft implantation for the treatment of vascular occlusive diseases have the problems of large surgical trauma or stent blockage in the later stage, resulting in poor distal perfusion.
A novel balloon catheter is designed, comprising a first balloon and a second balloon that are interlocked. The second balloon is used to expand the vessel wall outward in the occluded segment of the vessel and can be equipped with a cutting tool. Through interventional methods, the covered stent is pushed outward from inside the covered stent to increase the stent diameter and prevent postoperative blockage.
It improves the patency of blood flow within the covered stent, prevents postoperative stent blockage, and improves distal perfusion.
Smart Images
Figure CN224292333U_ABST
Abstract
Description
Technical Field
[0001] This utility model belongs to the field of balloon catheter technology, and specifically relates to a novel balloon catheter. Background Technology
[0002] For vascular occlusion diseases, such as coronary atherosclerotic heart disease (coronary heart disease), cerebrovascular diseases (such as cerebral artery stenosis), and peripheral artery diseases (such as lower extremity artery stenosis), arterial bypass surgery or percutaneous transluminal angioplasty (PTA) or covered stent implantation can be performed to bypass or dilate the arterial blockage caused by atherosclerosis and restore distal blood flow perfusion.
[0003] However, both methods have certain drawbacks. For example, in arterial bypass surgery, patients with longer occluded segments require longer surgical incisions, resulting in greater surgical trauma. Furthermore, proliferation can still occur at both ends of the grafted vessel and the anastomosis site with the artery, leading to blockage of the grafted vessel and subsequent poor distal perfusion. However, the postoperative patency rate of arterial bypass surgery is higher than that of endovascular stent grafting. In endovascular stent grafting, although interventional techniques are used and the trauma is less, the implanted stent can still become blocked in the stent later due to the elastic recoil of the vessel and the formation of proliferative growths, resulting in poor distal perfusion.
[0004] Therefore, how to overcome the above-mentioned technical defects is a problem that urgently needs to be solved by those skilled in the art. Utility Model Content
[0005] The purpose of this invention is to provide a novel balloon catheter that can improve the patency of blood flow within a stent implanted in an occluded segment of a blood vessel and prevent postoperative stent blockage.
[0006] To solve the above-mentioned technical problems, this utility model provides a novel balloon catheter, including a balloon, an inner tube, and an outer tube;
[0007] The balloon includes a first balloon and a second balloon that are fastened to each other. The cross-section of the balloon is a gourd shape formed by two semicircular rings. The center of the first balloon has a guidewire lumen for passing through a guidewire. Except for the guidewire lumen, the balloon is an inflation lumen. The second balloon is used to expand the blood vessel wall outward in the occluded segment of the blood vessel.
[0008] The outer tube is sleeved on the outside of the inner tube, and a balloon inflation cavity is formed between the inner tube and the outer tube. The balloon inflation cavity is connected to the balloon inflation cavity, and the inner lumen of the inner tube is connected to the guidewire lumen of the balloon.
[0009] Optionally, in the above-described novel balloon catheter, the second balloon has a cutting element on the side opposite to the first balloon.
[0010] Optionally, in the novel balloon catheter described above, the cutting element is disposed on the outer wall of the second balloon and arranged in a direction parallel to the axial direction of the second balloon.
[0011] Optionally, in the above-mentioned novel balloon catheter, the cutting element is a metal wire.
[0012] Optionally, in the novel balloon catheter described above, the cutting element is bonded to the outer wall of the second balloon by welding or adhesive.
[0013] Optionally, in the above-mentioned novel balloon catheter, the cross-section of the first balloon is an ellipse with a notch;
[0014] And / or, the cross-section of the second balloon is a circle or ellipse with a notch.
[0015] Optionally, in the above-described novel balloon catheter, the eccentricity of the first balloon is greater than that of the second balloon.
[0016] Optionally, in the above-described novel balloon catheter, the outer diameter of the first balloon is larger than the outer diameter of the second balloon.
[0017] Optionally, the novel balloon catheter described above also includes a handle, and the distal end of the handle or the outer tube is provided with a balloon inflation port for communicating with the balloon inflation cavity.
[0018] This utility model provides a novel balloon catheter, the advantages of which are:
[0019] When performing endovascular stent graft implantation for vascular occlusion using interventional methods, a standard balloon is first used for subendothelial angioplasty. When traversing the occluded segment of the vessel, the guidewire typically penetrates the intima from a normal point proximal to the affected area, then exits through the subintimal region to a normal point distal to the affected area. The stent graft is then implanted along the guidewire. After stent graft implantation, the subintimal space can be expanded to separate the adventitia and part of the lateral media, creating space for blood flow. However, due to the dense atherosclerotic plaque at the affected area, stent graft expansion is often poor. At this point, a second balloon is inserted inside the stent graft, with the second balloon facing the vessel wall. Once in place, the second balloon is filled with filler. The second balloon pushes the stent graft outwards from the vessel wall, effectively expanding the stent graft and causing rupture of the adventitia and part of the lateral media, allowing the stent graft to bulge outwards, increasing its diameter after implantation. The balloon is then withdrawn, allowing blood to flow freely through the stent graft and improving distal perfusion.
[0020] With the above setup, the second balloon can push the occluded vessel wall outward, or even rupture it, so that the covered stent can have space to bulge outward from the vessel, increasing the diameter of the covered stent after implantation, and ultimately improving the patency of blood flow within the covered stent in the occluded segment of the implanted vessel, preventing postoperative blockage of the covered stent. Attached Figure Description
[0021] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.
[0022] Figure 1 A schematic diagram of the structure of a novel balloon catheter provided for an embodiment of this utility model;
[0023] Figure 2 for Figure 1 A schematic diagram of the cross-section of the central balloon;
[0024] Figure 3 A schematic diagram of a guidewire passing through the occluded segment of a blood vessel and placed behind a covered stent, provided in an embodiment of this utility model (the straight shaded area represents the atherosclerotic plaque, and the Z-shaped curved area represents the covered stent).
[0025] Figure 4 This is a schematic diagram of the novel balloon catheter for implanting an occluded segment of a blood vessel in an expanded state, as provided in an embodiment of the present invention (this diagram shows the injection of filling material into the balloon; the balloon is only a schematic diagram and the inner and outer tube structures are not shown).
[0026] Figure 5 In order to be in Figure 4 A schematic diagram of the affected area after the removal of the novel balloon catheter from the occluded segment of the blood vessel, as provided in this embodiment of the present invention (effect diagram after treatment of the occluded segment of the blood vessel).
[0027] exist Figures 3-5 In the diagram: red represents the outer membrane of the blood vessel, purple represents the middle membrane, and blue represents the inner membrane.
[0028] exist Figures 1-5 middle:
[0029] 110 - Balloon; 120 - Inner tube; 130 - Outer tube; 131 - Balloon inflation port; 140 - Cutting piece;
[0030] 200-guidewire;
[0031] 300-Covered Scaffold;
[0032] 400 - Occluded segment of the blood vessel. Detailed Implementation
[0033] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain this utility model, and should not be construed as limiting this utility model.
[0034] In the description of this application, it should be understood that the terms "proximal" and "distal" throughout refer to near and far relative to the operator. In use, the end closer to the doctor or operator is the "proximal" end, i.e., the end where the operator is located, and the end farther from the doctor or operator is the "distal" end, i.e., the end where the balloon is located. The above descriptions of orientation are for ease of description and simplification only, 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 application.
[0035] The core of this invention is to provide a novel balloon catheter that can improve the patency of blood flow within a stent implanted in an occluded segment of a blood vessel and prevent postoperative stent blockage.
[0036] To enable those skilled in the art to better understand the technical solutions provided by this utility model, the present utility model will be further described in detail below with reference to the accompanying drawings and specific embodiments.
[0037] For details, please refer to Figures 1-5 The present invention provides a novel balloon catheter, comprising a balloon 110, an inner tube 120, and an outer tube 130.
[0038] The balloon 110 includes a first balloon and a second balloon that are snapped together. The cross-section of the balloon 110 is a gourd shape formed by two semicircular rings. The center of the first balloon has a guidewire lumen for passing through the guidewire 200. Except for the guidewire lumen, the balloon 110 is an inflation lumen. The second balloon is used to expand the blood vessel wall outward in the occluded segment of the blood vessel.
[0039] The outer tube 130 is sleeved on the outside of the inner tube 120. The distal end of the balloon 110 is connected to the distal end of the inner tube 120, and the proximal end of the balloon 110 is connected to the distal end of the outer tube 130. The proximal ends of the outer tube 130 and the inner tube 120 are both connected to the handle. A balloon inflation cavity is formed between the inner tube 120 and the outer tube 130. The inflation cavity of the balloon 110 is connected to the balloon inflation cavity, and the inner lumen of the inner tube 120 is connected to the guidewire lumen of the balloon.
[0040] It should be noted that the blood vessel wall is generally divided into three layers: 1. The intima, the innermost layer of the blood vessel wall, adjacent to the lumen, and the thinnest layer. 2. The media, located between the intima and adventitia, is responsible for maintaining the elasticity and stability of the blood vessel wall and participates in regulating vasoconstriction and vasodilation. 3. The adventitia, the outermost layer of the blood vessel wall, provides additional support and protection for the blood vessel.
[0041] The term "subendothelial" in this plan refers to the area below the endometrium, that is, between the endometrium and the media.
[0042] This protocol provides a novel balloon catheter, the usage of which is as follows: When performing covered stent implantation for vascular occlusion using interventional methods, subendothelial angioplasty is first performed using a standard balloon. When passing through the occluded segment 400, the guidewire 200 typically penetrates the intima from a normal point proximal to the affected area, entering the subintimal space (between the intima and media). It then exits from the normal point distal to the affected area, and subsequently, the covered stent 300 is implanted along the guidewire 200. After implantation of the covered stent 300, the subintimal space can be expanded to separate the adventitia and part of the lateral media, creating space for blood flow. However, due to the dense atherosclerotic plaque at the affected area, the covered stent 300 may not expand properly (e.g., Figure 3 (As shown). At this point, balloon 110 is pushed into the covered stent 300, with the second balloon facing the vessel wall. After it is in place, filling material is injected into balloon 110. The second balloon can push the covered stent 300 outward from the vessel wall from within the covered stent 300, that is, the covered stent 300 is expanded by balloon 110 (as shown). Figure 4 As shown), the balloon 110 ruptures the adventitia and part of the lateral media, allowing the covered stent 300 to bulge outwards from the blood vessel, increasing the diameter of the stent 300 after implantation. Then, the balloon 110 is withdrawn, allowing blood to flow freely through the covered stent 300, improving distal perfusion (e.g., Figure 5 (As shown).
[0043] With the above setup, the second balloon can push the occluded blood vessel wall outward, or even rupture it, so that the covered stent 300 can have space to bulge outward from the blood vessel, increasing the diameter of the covered stent 300 after implantation, and ultimately improving the patency of blood flow in the covered stent 300 implanted in the occluded segment 400 of the blood vessel, preventing postoperative blockage inside the covered stent 300.
[0044] In a specific embodiment, the second balloon has a cutting element 140 on the side opposite to the first balloon. By using the cutting element 140 to contact the vascular membrane, the pressure generated can cause the adventitia and part of the media on the outer side of the blood vessel to rupture along the direction of pressure accumulation. This can effectively achieve precise alignment of the cutting element 140 with the lesion location, and the cutting element 140 can directionally cut the lesion, greatly improving the vascular stenosis and dilation effect during the angioplasty procedure.
[0045] like Figure 1 The cutting element 140 is disposed on the outer wall of the second balloon and arranged in a direction parallel to the axial direction of the second balloon. Specifically, the cutting element 140 is a metal wire, which can be connected to the second balloon by welding or adhesive bonding.
[0046] In a specific embodiment, the first balloon has an elliptical cross-section with a notch; and / or, the second balloon has a circular or elliptical cross-section with a notch. The first and second balloons are connected to each other at the notch to form a single unit.
[0047] Furthermore, the eccentricity of the first balloon is greater than that of the second balloon, and the first balloon provides effective support for the second balloon. Furthermore, the outer diameter of the first balloon is greater than the outer diameter of the second balloon.
[0048] In this design, the balloon 110 is shaped like a gourd in cross-section, with a metal wire longitudinally bonded to the top of the gourd. The reason for this design is that the balloon 110 needs to generate sufficient pressure during use so that the metal wire can rupture the adventitia and part of the lateral tunica media of the blood vessel.
[0049] If the metal wire is directly installed in a traditional circular balloon, the desired technical effect cannot be achieved. Therefore, the balloon 110 itself is designed with a cross-section consisting of a large ellipse with a large eccentricity and a smaller circle or ellipse (i.e., as shown in the image). Figure 2 The overall shape is like a gourd, so that the balloon 110 has a sufficiently large thickness after being filled with the filling material to generate enough pressure to cut the blood vessel wall.
[0050] The first balloon adopts an elliptical shape with a notch. Because the elliptical part of the "gourd" shaped balloon 110 has a wider long axis design, compared with the traditional circular balloon, the elliptical shape is not easy to rotate and slide in the expanded lumen, and it is easy to position the metal wire.
[0051] This solution also includes a handle, and the distal end of the handle or outer tube 130 is provided with a balloon inflation port 131 for communicating with the balloon inflation cavity, through which liquid / filler is injected to inflate the balloon 110.
[0052] The balloon 110 is delivered to the occluded segment 400 of the narrowed or blocked blood vessel through the handle, inner tube 120 and outer tube 130. Then, the balloon 110 is filled with filling material to dilate the blood vessel, thereby relieving the narrowing or blockage, improving blood flow and relieving symptoms.
[0053] When using the novel balloon catheter described in the above specific embodiments to perform covered stent 300 implantation for the treatment of atherosclerotic disease via interventional methods, the following procedures are followed:
[0054] Subendothelial angioplasty is performed using a conventional balloon, bypassing the atherosclerotic plaque in the occluded segment 400 to prevent it from affecting the expansion of the covered stent 300 and increasing the patency rate by increasing the acquisition rate of the new lumen. At this time, the new lumen formed by the subendothelial angioplasty has a crescent-shaped cross-section under the combined pressure and elasticity of the atherosclerotic plaque, the adventitia, and part of the lateral media of the occluded segment 400. Subsequently, the covered stent 300 is implanted along the guidewire, thus achieving the implantation of the covered stent 300 in the occluded segment 400.
[0055] It should be noted that after implantation of the 300 covered stent, the new lumen created by the subendothelial angioplasty is relatively tight and narrow due to the combined effects of the sclerotic plaque, the adventitia, and part of the media, resulting in poor stent expansion. To address these issues, the following procedures are necessary.
[0056] Balloon 110 is pushed into the covered stent 300, so that the second balloon on balloon 110 faces the blood vessel wall (in the case where the second balloon is fitted with a wire, the wire also needs to face the adventitia of the blood vessel).
[0057] After reaching the occluded segment 400 of the blood vessel, filling material is injected into balloon 110. The second balloon can push outward from the inside of the covered stent 300 to the outside of the blood vessel wall, causing the adventitia and part of the lateral media of the blood vessel to rupture. The covered stent 300 gains space and bulges outward from the blood vessel.
[0058] After increasing the diameter of the covered stent 300 after implantation, the balloon 110 is withdrawn to allow blood to flow smoothly through the covered stent 300.
[0059] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.
[0060] This article uses specific examples to illustrate the principles and implementation methods of this utility model. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this utility model. It should be noted that for those skilled in the art, several improvements and modifications can be made to this utility model without departing from the principles of this utility model, and these improvements and modifications also fall within the protection scope of the claims of this utility model.
Claims
1. A novel balloon catheter, characterized in that, It includes a balloon (110), an inner tube (120), and an outer tube (130); The balloon (110) includes a first balloon and a second balloon that are fastened to each other. The cross-section of the balloon (110) is a gourd shape formed by two semicircular rings. The center of the first balloon has a guidewire lumen for passing through the guidewire (200). Except for the guidewire lumen, the balloon (110) is an inflation lumen. The second balloon is used to expand the blood vessel wall outward in the occluded segment of the blood vessel. The outer tube (130) is sleeved on the outside of the inner tube (120), and a balloon inflation cavity is formed between the inner tube (120) and the outer tube (130). The inflation cavity of the balloon (110) is connected to the balloon inflation cavity, and the inner cavity of the inner tube (120) is connected to the guidewire cavity of the balloon.
2. The novel balloon catheter according to claim 1, characterized in that, The second balloon has a cutting element (140) on the side opposite to the first balloon.
3. The novel balloon catheter according to claim 2, characterized in that, The cutting element (140) is disposed on the outer wall of the second balloon and arranged in a direction parallel to the axial direction of the second balloon.
4. The novel balloon catheter according to claim 2, characterized in that, The cutting element (140) is a metal wire.
5. The novel balloon catheter according to claim 2, characterized in that, The cutting element (140) is bonded to the outer wall of the second balloon by welding or glue.
6. The novel balloon catheter according to claim 1, characterized in that, The first balloon has an elliptical cross-section with a notch; And / or, the cross-section of the second balloon is a circle or ellipse with a notch.
7. The novel balloon catheter according to claim 6, characterized in that, The eccentricity of the first balloon is greater than that of the second balloon.
8. The novel balloon catheter according to claim 6, characterized in that, The outer diameter of the first balloon is larger than the outer diameter of the second balloon.
9. The novel balloon catheter according to claim 1, characterized in that, It also includes a handle, and the distal end of the handle or the outer tube (130) is provided with a balloon inflation port (131) for communicating with the balloon inflation cavity.