High-pressure fatigue-resistant coronary artery dilatation balloon and use method

Abstract

The invention relates to the field of medical instruments, and discloses a high-pressure fatigue-resistant coronary artery dilatation balloon and a using method.The high-pressure fatigue-resistant coronary artery dilatation balloon comprises a balloon body, a catheter rod is arranged in the balloon body in a penetrating mode, two flexible diaphragms are arranged outside the catheter rod, and the two flexible diaphragms are arranged in the balloon body; two flexible diaphragms are arranged in the balloon body and divide the interior of the balloon body into a first cavity, a second cavity and a third cavity, a filling layer is arranged in the catheter rod, and three air delivery pipes are fixedly connected into the filling layer. The interior of the balloon is divided into the three independent expansion cavities through the flexible diaphragm, differential pressure control of the cavities can be achieved through the three independent air delivery pipes in the catheter rod, the two ends of a lesion blood vessel can be expanded firstly during an operation, then the middle of the lesion blood vessel is expanded, pre-expansion and post-expansion are achieved, and the operation efficiency is improved. The functions of a semi-compliant balloon and a non-compliant balloon are integrated, the types of the balloons do not need to be switched in an operation, and the operation efficiency is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a high-pressure fatigue-resistant coronary artery dilation balloon and its usage method. Background Technology

[0002] Against the backdrop of an accelerating global population aging and the normalization of unhealthy lifestyle habits, cardiovascular disease has become the leading cause of threats to human health. The incidence of coronary heart disease continues to rise, placing a heavy burden on patients' families and the social healthcare system. With the rapid development of interventional medicine, minimally invasive interventional therapy, with its advantages of minimal trauma, rapid recovery, and definite efficacy, has become one of the core methods for treating coronary heart disease. Coronary artery dilation balloons, as an indispensable basic device in coronary interventional therapy, play a crucial role in opening narrowed or blocked coronary arteries and restoring myocardial blood supply.

[0003] Existing coronary artery dilation balloons mainly consist of a balloon body, catheter rod, tip, handle, and inflator. During operation, the folded and contracted balloon is delivered to the narrowed coronary artery through the catheter. The inflator injects a pressure medium into the balloon to inflate it. The radial pressure generated by the expansion dilates the narrowed vessel wall and compresses the atherosclerotic plaque. Once the lumen of the vessel is restored to patency, the pressure inside the balloon is released to cause the balloon to retract. The balloon is then withdrawn from the body along with the catheter, thereby achieving coronary revascularization.

[0004] In existing technologies, doctors need to change coronary dilation balloons of different types and specifications multiple times during surgery, which not only increases the complexity of surgical procedures and prolongs the operation time, but also increases the cost of medical consumables due to frequent instrument switching, thus reducing the overall efficiency of surgery. Therefore, a high-pressure fatigue-resistant coronary dilation balloon and its usage method are proposed. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a high-pressure fatigue-resistant coronary artery dilation balloon and its usage method, which solves the problem of low surgical efficiency caused by multiple balloon replacements during surgery.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] The first aspect of this invention provides a high-pressure fatigue-resistant coronary dilation balloon, comprising a balloon body, a catheter rod inserted through the balloon body, two flexible diaphragms disposed outside the catheter rod, the two flexible diaphragms being disposed inside the balloon body, the two flexible diaphragms dividing the interior of the balloon body into a first cavity, a second cavity, and a third cavity, a filling layer disposed inside the catheter rod, and three gas delivery tubes fixedly connected inside the filling layer, each of the three gas delivery tubes having an air outlet, the air outlet communicating with the first cavity, the second cavity, and the third cavity, respectively.

[0008] Preferably, the outer wall of the balloon body is provided with anti-slip anchoring rings at both ends, the anti-slip anchoring rings are integrally blow-molded with the balloon body, and the anti-slip anchoring rings are provided with anti-slip textures.

[0009] Preferably, the outer wall of the middle section of the balloon body is provided with multiple annular protrusions, and the edges of the annular protrusions are designed to be arc-shaped.

[0010] Preferably, the second cavity is disposed between the first cavity and the third cavity, and the air intake of the first cavity, the second cavity and the third cavity can be controlled respectively through the three air supply pipes.

[0011] Preferably, the catheter rod is fixedly connected to a tip, which is a soft tip used to open a vascular channel for the balloon body.

[0012] Preferably, a silicone protective ring is provided between the balloon body and the catheter rod, and the silicone protective ring is integrally connected to the balloon body by a hot-melt process.

[0013] Preferably, the outer wall of the catheter rod is provided with two marking rings, which are respectively disposed inside the first cavity and the third cavity.

[0014] Preferably, the annular protrusion is integrally blow-molded with the balloon body, and the balloon body can support the annular protrusion.

[0015] Preferably, the annular protrusion acts on calcified plaques in blood vessels, and the annular protrusion achieves plaque fragmentation and expansion through radial force.

[0016] A second aspect of the present invention provides a method for using a high-pressure fatigue-resistant coronary dilation balloon, comprising the following steps:

[0017] S1. Positioning and Insertion: The tip of the catheter rod is pushed to open a vascular channel for the balloon body. The gap between the balloon body and the catheter rod is sealed by the silicone protective ring. The balloon body is confirmed to have reached the location of the diseased blood vessel by observing the marking ring.

[0018] S2. Expansion and Anchoring at Both Ends: First, the first cavity and the third cavity are inflated through the two gas delivery tubes respectively to expand the flexible diaphragm and realize the expansion at both ends of the balloon body, so that the anti-slip anchoring ring contacts the inner wall of the blood vessel and prevents the balloon body from sliding along the blood vessel axis during the subsequent high-pressure expansion stage.

[0019] S3. Mid-section dilation and lesion treatment: The second cavity is inflated through another gas inlet tube to dilate the mid-section of the balloon body. The balloon body dilation drives the annular convex ring to act on the hard part of the calcified plaque. The radial force is used to break up and dilate the plaque, completing the pre-dilation and post-dilation of the blood vessel.

[0020] S4. Stent loading and implantation: The gas in the balloon body is released and withdrawn, the stent is placed on the balloon body, the anti-slip anchoring ring is used to prevent the stent from falling off, the balloon body is delivered to the diseased blood vessel again, the balloon body is inflated through the three gas delivery tubes, and the stent is opened to support the inner wall of the blood vessel.

[0021] This invention provides a high-pressure, fatigue-resistant coronary artery dilation balloon and its method of use. It has the following beneficial effects:

[0022] 1. This invention divides the interior of the balloon into three independent expansion chambers through a flexible diaphragm. Each chamber can achieve differentiated pressure control through three independent gas delivery tubes in the catheter rod. During surgery, the two ends of the diseased blood vessel can be expanded first, and then the middle part can be expanded to achieve pre-dilation and post-dilation. It integrates the functions of semi-compliant and non-compliant balloons. There is no need to switch balloon types during surgery, which reduces the workload of doctors and improves surgical efficiency.

[0023] 2. This invention features anti-slip anchoring rings at both ends of the balloon. The anti-slip anchoring rings are integrally blow-molded with the balloon, which does not affect the high-pressure resistance of the overall structure. During the initial low-pressure expansion of the balloon, the anti-slip anchoring rings first adhere to and fix with the blood vessel wall, preventing the balloon from slipping along the blood vessel axis during the high-pressure expansion phase. This avoids damage to the blood vessel wall caused by repeated adjustments to the balloon position. At the same time, during the stent installation process, the anti-slip anchoring rings can fix the position of the stent, preventing the stent from detaching from the balloon during transportation.

[0024] 3. The present invention has multiple annular protrusions on the outer wall of the middle section of the balloon. The protrusions are integrally formed with the balloon body. For eccentric calcified lesions, the protrusions can act on the hard parts of the calcified plaque during high-pressure expansion, and realize the fragmentation and expansion of the plaque through radial force. The arc-shaped edge design of the protrusions can avoid cutting damage to the blood vessel wall. At the same time, the protrusion structure can disperse the circumferential stress of the balloon and reduce fatigue damage caused by repeated expansion. Attached Figure Description

[0025] Figure 1 This is a perspective view of the present invention;

[0026] Figure 2 This is a schematic diagram of the anti-slip anchoring ring of the present invention;

[0027] Figure 3 for Figure 2 Enlarged view of point A in the middle;

[0028] Figure 4 This is a schematic diagram of the flexible diaphragm of the present invention;

[0029] Figure 5 This is a schematic diagram of the marking ring of the present invention;

[0030] Figure 6 for Figure 5 Enlarged view of section B in the middle.

[0031] The components include: 1. balloon body; 2. catheter rod; 3. flexible diaphragm; 4. first cavity; 5. second cavity; 6. third cavity; 7. filling layer; 8. gas delivery tube; 9. anti-slip anchoring ring; 10. annular protrusion; 11. head end; 12. silicone protective ring; and 13. marking ring. Detailed Implementation

[0032] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. 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.

[0033] like Figures 2 to 4 As shown, this embodiment of the invention provides a high-pressure fatigue-resistant coronary artery dilation balloon, including a balloon body 1. The balloon body 1 is made of high-pressure resistant medical nylon material, which has excellent fatigue resistance and can withstand repeated dilation pressure during coronary intervention. A catheter rod 2 is inserted inside the balloon body 1, and the catheter rod 2 is filled with a filling layer 7. Three independent gas delivery tubes 8 are also inserted through it. Two flexible diaphragms 3 are provided outside the catheter rod 2. The flexible diaphragms 3 are made of highly elastic medical silicone, which has good deformation recovery ability. The two flexible diaphragms 3 are located inside the balloon body 1, and the two flexible diaphragms 3 divide the interior of the balloon body 1 into a first cavity 4, a second cavity 5, and a third cavity 6. The three-chamber structure 6 has three chambers: the first chamber 4, located near the operating end, is formed by a flexible diaphragm 3 and the inner wall of the balloon; the second chamber 5, located between two flexible diaphragms 3, is the core expansion chamber; and the third chamber 6, located near the head end 11, is also formed by a flexible diaphragm 3 and the inner wall of the balloon. The catheter rod 2 has a filling layer 7 inside, which fills the hollow interior of the catheter rod 2 and has high stability. Three gas delivery tubes 8 are fixedly connected inside the filling layer 7, each corresponding to one chamber. The tube body is buried in the filling layer 7 and is connected to the corresponding chamber only through the gas outlet. Each of the three gas delivery tubes 8 has a gas outlet, which is connected to the first chamber 4, the second chamber 5, and the third chamber 6, respectively.

[0034] Specifically, with the catheter rod 2 as the core support, the internal filling layer 7 fixes three independent gas delivery tubes 8. Two flexible diaphragms 3 divide the inside of the balloon body 1 into a first cavity 4 near the operating end, a second cavity 5 for core expansion, and a third cavity 6 near the head end 11. The air outlets of the three gas delivery tubes 8 are connected to the three cavities respectively, ultimately achieving the effect of independent and controllable inflation of multiple cavities inside the balloon. This design utilizes the multi-cavity structure to adapt to the local expansion needs of different lesions, and relies on high-pressure resistant materials and independent gas delivery structure to improve the fatigue resistance and expansion accuracy of the balloon.

[0035] like Figure 1 , Figure 4 and Figure 6 As shown, the balloon body 1 has anti-slip anchoring rings 9 at both ends of its outer wall. The anti-slip anchoring rings 9 are distributed on the outer wall of the conical area at both ends of the balloon body 1. The ring surface has fine anti-slip texture. When the balloon is partially inflated, the anti-slip anchoring rings 9 can increase the friction between the balloon and the blood vessel wall, prevent the balloon from sliding at the lesion site, and improve the stability of the inflation operation. The anti-slip anchoring rings 9 and the balloon body 1 are integrally blow-molded. The anti-slip anchoring rings 9 have anti-slip texture. The outer wall of the middle section of the balloon body 1 has multiple annular protrusions 10. When inflated, the annular protrusions 10 can concentrate radial force on the plaque and break up hard calcified tissue. The edge of the annular protrusions 10 is designed to be arc-shaped. The second cavity 5 is located between the first cavity 4 and the third cavity 6. The air intake of the first cavity 4, the second cavity 5 and the third cavity 6 can be controlled by three air supply tubes 8 respectively.

[0036] Specifically, the anti-slip anchoring ring 9 on the outer wall of the balloon body 1 is integrally blow-molded with the balloon and has anti-slip texture. When the balloon is partially expanded, the friction between the ring and the blood vessel wall prevents the balloon body 1 from sliding at the lesion site, thus improving the stability of operation. At the same time, the annular protrusion 10 in the middle section of the balloon body 1 can concentrate radial force on the calcified plaque during expansion, thereby breaking up the plaque. Combined with the compartmentalized structure of the first cavity 4, the second cavity 5, and the third cavity 6, and the independent control of the three gas delivery tubes 8, the balloon body 1 is effectively controlled.

[0037] like Figure 1 , Figure 2 and Figure 5As shown, the catheter rod 2 is fixedly connected to a tip 11 at its front end. During interventional advancement, the tip 11 can gently pass through narrow and tortuous coronary arteries, opening an advance channel for the balloon body 1. This avoids scratching the vascular intima and improves operational safety. The tip 11 is a soft front end used to open the vascular channel for the balloon body 1. A silicone protective ring 12 is provided between the balloon body 1 and the catheter rod 2. The silicone protective ring 12 is used to seal the gap between the inside and outside of the balloon, preventing gas leakage from the connection seam after the cavity is inflated. The silicone protective ring 12 is integrally formed with the balloon body 1 through a heat fusion process. The catheter rod 2 has two marking rings 13 on its outer wall. Under X-ray fluoroscopy during interventional surgery, the marking rings 13 can be clearly visualized, helping the operator to determine the position and expansion range of the balloon in the blood vessel, ensuring that the balloon accurately covers the lesion area. The two marking rings 13 are respectively set inside the first cavity 4 and the third cavity 6. The annular protrusion 10 is integrally blow-molded with the balloon body 1. The balloon body 1 can support the annular protrusion 10. The annular protrusion 10 acts on the calcified plaque in the blood vessel. The annular protrusion 10 achieves plaque fragmentation and expansion through radial force.

[0038] Specifically, the vascular access is gently opened during intervention by using the tip 11 at the front end of the catheter rod 2, avoiding scratching the vascular intima to improve operational safety. The silicone protective ring 12 between the balloon body 1 and the catheter rod 2 seals the gap between the inside and outside of the balloon and prevents leakage of the cavity during inflation. In conjunction with the two marking rings 13 on the outer wall of the catheter rod 2, the balloon position and expansion range are visualized under X-ray fluoroscopy. At the same time, the ring-shaped protrusion 10 integrally blow-molded in the balloon body 1 can break and expand calcified plaques in the blood vessel by radial force after the balloon is inflated.

[0039] The method of using a high-pressure fatigue-resistant coronary artery dilation balloon described below can be referred to in conjunction with the method described above.

[0040] A method for using a high-pressure fatigue-resistant coronary dilation balloon includes the following steps:

[0041] S1. Positioning and insertion: The balloon body 1 opens the vascular channel by pushing the tip 11 of the catheter rod 2, the gap between the balloon body 1 and the catheter rod 2 is sealed by the silicone protective ring 12, and the balloon body 1 is confirmed to reach the diseased blood vessel by observing the marking ring 13.

[0042] S2. Expansion and anchoring at both ends: First, the first cavity 4 and the third cavity 6 are inflated through two gas inlet tubes 8 respectively, which expands the flexible diaphragm 3 and expands both ends of the balloon body 1, so that the anti-slip anchoring ring 9 contacts the inner wall of the blood vessel and prevents the balloon body 1 from sliding along the blood vessel axis during the subsequent high-pressure expansion stage.

[0043] S3, Central dilation and lesion treatment: The second cavity 5 is inflated through another air inlet tube 8 to dilate the middle of the balloon body 1. The balloon body 1 is expanded to drive the annular protrusion 10 to act on the hard part of the calcified plaque. The plaque is broken and dilated by radial force, thus completing the pre-dilation and post-dilation of the blood vessel.

[0044] S4. Stent loading and implantation: The gas in the balloon body 1 is released and withdrawn, the stent is placed on the balloon body 1, the anti-slip anchoring ring 9 is used to prevent the stent from falling off, the balloon body 1 is delivered to the diseased blood vessel again, the balloon body 1 is inflated through the three gas supply tubes 8, and the stent is opened to support the inner wall of the blood vessel.

[0045] The device in this embodiment can be used to execute the above method embodiments, and its principle and technical effects are similar, so they will not be described again here.

Claims

1. A high-pressure fatigue-resistant coronary artery dilation balloon, comprising a balloon body (1), characterized in that, The balloon body (1) is provided with a catheter rod (2) inside. Two flexible diaphragms (3) are provided outside the catheter rod (2). The two flexible diaphragms (3) are located inside the balloon body (1). The two flexible diaphragms (3) divide the interior of the balloon body (1) into a first cavity (4), a second cavity (5) and a third cavity (6). The catheter rod (2) is provided with a filling layer (7). Three gas delivery tubes (8) are fixedly connected inside the filling layer (7). Each of the three gas delivery tubes (8) is provided with an air outlet. The air outlets are respectively connected to the first cavity (4), the second cavity (5) and the third cavity (6).

2. The high-pressure fatigue-resistant coronary dilation balloon according to claim 1, characterized in that, The outer walls of the balloon body (1) are provided with anti-slip anchoring rings (9) at both ends. The anti-slip anchoring rings (9) are integrally blow-molded with the balloon body (1), and the anti-slip anchoring rings (9) are provided with anti-slip textures.

3. The high-pressure fatigue-resistant coronary artery dilation balloon according to claim 1, characterized in that, The outer wall of the middle section of the balloon body (1) is provided with multiple annular protrusions (10), and the edges of the annular protrusions (10) are designed to be arc-shaped.

4. The high-pressure fatigue-resistant coronary dilation balloon according to claim 1, characterized in that, The second cavity (5) is located between the first cavity (4) and the third cavity (6), and the first cavity (4), the second cavity (5) and the third cavity (6) can be controlled to receive air through the three air supply pipes (8).

5. The high-pressure fatigue-resistant coronary dilation balloon according to claim 1, characterized in that, The catheter rod (2) is fixedly connected to a head end (11) at its front end. The head end (11) is a soft front end used to open a vascular channel for the balloon body (1).

6. The high-pressure fatigue-resistant coronary dilation balloon according to claim 1, characterized in that, A silicone protective ring (12) is provided between the balloon body (1) and the catheter rod (2), and the silicone protective ring (12) is integrally connected to the balloon body (1) by a hot-melt process.

7. The high-pressure fatigue-resistant coronary artery dilation balloon according to claim 1, characterized in that, The outer wall of the catheter rod (2) is provided with two marking rings (13), and the two marking rings (13) are respectively located inside the first cavity (4) and the third cavity (6).

8. A high-pressure fatigue-resistant coronary artery dilation balloon according to claim 3, characterized in that, The annular protrusion (10) is integrally blow-molded with the balloon body (1), and the balloon body (1) can support the annular protrusion (10).

9. A high-pressure fatigue-resistant coronary artery dilation balloon according to claim 8, characterized in that, The annular protrusion (10) acts on calcified plaques in blood vessels, and the annular protrusion (10) breaks up and expands the plaques through radial force.

10. A method for using a high-pressure fatigue-resistant coronary dilation balloon, characterized in that, The application of the high-pressure fatigue-resistant coronary dilation balloon according to any one of claims 1-9 includes the following steps: S1. Positioning and insertion: The tip (11) is pushed by the catheter rod (2) to open the blood vessel channel for the balloon body (1), the gap between the balloon body (1) and the catheter rod (2) is sealed by the silicone protective ring (12), and the balloon body (1) is confirmed to have reached the location of the diseased blood vessel by observing the marking ring (13). S2, Expansion and Anchoring at Both Ends: First, the first cavity (4) and the third cavity (6) are inflated through the two gas delivery tubes (8) respectively, which expands the flexible diaphragm (3) and expands both ends of the balloon body (1), so that the anti-slip anchoring ring (9) contacts the inner wall of the blood vessel and prevents the balloon body (1) from sliding along the blood vessel axis during the subsequent high-pressure expansion stage; S3, Central dilation and lesion treatment: The second cavity (5) is inflated through another gas inlet tube (8) to dilate the middle of the balloon body (1). The balloon body (1) is expanded to drive the annular protrusion (10) to act on the hard part of the calcified plaque. The plaque is broken and dilated by radial force, thus completing the pre-dilation and post-dilation of the blood vessel. S4. Stent loading and implantation: The gas in the balloon body (1) is released and withdrawn, the stent is placed on the balloon body (1), the anti-slip anchoring ring (9) is used to prevent the stent from falling off, the balloon body (1) is delivered to the lesion blood vessel again, the balloon body (1) is inflated through the three gas delivery tubes (8), and the stent is opened to support the inner wall of the blood vessel.

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