Spiral enhanced coronary balloon dilatation catheter

Abstract

The utility model discloses a spiral enhanced coronary balloon dilatation catheter which comprises a catheter body, a guide wire cavity and a filling cavity are arranged in the catheter body, the guide wire cavity is located in the middle of the catheter body and penetrates through the two ends of the catheter body, the filling cavity is located on the outer side of the guide wire cavity, one end of the filling cavity is connected with a balloon, and the other end of the filling cavity is located at the near end of the catheter body. The balloon is located at the far end of the catheter body and close to the end, the balloon is fixed to the outer wall of the catheter body, and a spiral reinforcing structure is arranged on the surface of the balloon and protrudes out of the surface of the balloon. The spiral reinforcing structure is of a spiral structure and spirally surrounds the surface of the balloon in the length direction of the catheter body. According to the balloon dilator, a lesion area can be uniformly expanded under high pressure, the risk of balloon rupture is reduced, and the balloon is effectively prevented from shifting or slipping in the treatment process, so that the safety and the success rate of a coronary intervention operation are improved.

Description

TECHNICAL FIELD

[0001] The utility model relates to a kind of spiral reinforced coronary balloon dilatation catheter, belong to medical product technical field. BACKGROUND

[0002] Coronary intervention surgery (PCI) is one of the important means of treating coronary heart disease, and usually through balloon dilatation catheter to dilate stenosis or occluded coronary artery to restore blood flow. However, the existing coronary balloon dilatation catheter faces many challenges in dealing with complex lesions, especially calcified lesions, stubborn plaques and curved vessels. With the development of interventional technology, the requirements for balloon dilatation catheter are also increasing, requiring higher mechanical strength, more precise expansion control and greater safety.

[0003] The existing coronary balloon dilatation catheter adopts ellipsoidal or other conventional shapes, and selects appropriate balloon size according to the diameter of the lesion vessel. These catheters perform well in daily PCI surgery, but some important shortcomings are exposed when dealing with complex lesions: ① Difficulty in dealing with calcified lesions: In highly calcified coronary artery lesions, traditional balloon dilatation catheters often have difficulty in effectively expanding plaques, resulting in poor treatment effect. In addition, when high pressure is expanded, the traditional balloon is prone to local overexpansion or rupture at the calcified lesion, increasing the risk of surgery. ② Uneven balloon displacement and expansion: During expansion, the balloon is prone to displacement or slipping due to the complex shape of the blood vessel (such as acute bending, bifurcated lesions), resulting in uneven expansion and inability to accurately relieve stenosis, affecting treatment effect. ③ High pressure operation risk: To ensure sufficient expansion of the lesion, high pressure operation is often required. Traditional balloon is prone to deformation or rupture under high pressure, especially when dealing with stubborn lesions, increasing the risk of surgical complications. ④ Insufficient mechanical support: The existing balloon provides limited mechanical support during expansion, especially when dealing with hardened or calcified lesions, it is difficult to maintain a stable expansion shape and cannot evenly distribute expansion force, resulting in unsatisfactory treatment effect. In order to cope with these challenges, it is an urgent need to develop a balloon dilatation catheter with higher mechanical performance. SUMMARY

[0004] The technical problem to be solved by the utility model is how to avoid balloon displacement and ensure uniform expansion to fully expand the lesion area, while preventing overexpansion or rupture.

[0005] To solve the above technical problems, the technical scheme of the utility model provides a kind of spiral reinforced coronary balloon dilatation catheter, including catheter body, catheter body is equipped with guide wire cavity and filling cavity, guide wire cavity is located in the middle position of catheter body, and it is through the both ends of catheter body, filling cavity is located in the outside of guide wire cavity, filling cavity one end is connected balloon, the other end is located in the proximal end of catheter body, balloon is located in catheter body distal end near end position, balloon is fixed on the outer wall of catheter body, its characterized in that, the surface of the balloon is equipped with spiral reinforcing structure, and protrude from the surface of balloon;The shape of spiral reinforcing structure is spiral structure, and spiral is wound on the surface of balloon along the length direction of catheter body.

[0006] Preferably, the other end of the filling cavity is connected with a balloon expansion pressure pump for filling the balloon with a contrast agent;A groove is formed on the outer wall of the catheter body to accommodate the balloon;After the balloon is filled with the contrast agent, the balloon protrudes from the outer wall of the catheter body.

[0007] Preferably, the elastic strength of the spiral reinforcing structure is less than that of the balloon;The spiral reinforcing structure provides radial support force and anti-torsion ability to ensure uniform pressure distribution during balloon expansion.

[0008] Preferably, a radiopaque ring is embedded in the catheter body and covers the balloon.

[0009] The catheter overcomes the deficiencies of existing coronary balloon dilatation catheters in handling complex lesions, such as calcified lesions, stubborn plaques and curved blood vessels, which include uneven expansion, balloon rupture and high risk of displacement.

[0010] The spiral reinforced coronary balloon dilatation catheter is mainly used in coronary intervention surgery (PCI), especially in handling complex lesions, such as calcified lesions, stubborn plaques and curved blood vessels, by providing uniform expansion force and high pressure resistance to help restore the blood flow of stenotic or occluded coronary arteries.

[0011] The utility model has high mechanical strength and stability, and is specially used to solve the challenges faced by traditional balloons in handling complex lesions. The utility model can uniformly expand the lesion area under high pressure, reduce the risk of balloon rupture, and effectively prevent the balloon from shifting or slipping during treatment, thereby improving the safety and success rate of coronary intervention surgery.

[0012] The utility model discloses a spiral reinforcing structure integrated on the surface of the balloon, which provides additional radial support force and torsional strength, allowing more uniform dispersion of pressure during expansion, preventing balloon rupture or displacement. In addition, the spiral structure can also enhance the stability of the balloon under high pressure, ensuring better treatment effect when dealing with complex and stubborn lesions, thereby greatly improving the safety and success rate of coronary intervention surgery.

[0013] The utility model discloses a spiral reinforcing structure integrated on the surface of the balloon, which provides additional radial support force and torsional strength, allowing more uniform dispersion of pressure during expansion, preventing balloon rupture or displacement. In addition, the spiral structure can also enhance the stability of the balloon under high pressure, ensuring better treatment effect when dealing with complex and stubborn lesions, thereby greatly improving the safety and success rate of coronary intervention surgery.

[0014] The utility model discloses at least one advantage as follows:

[0015] a. Uniform expansion force: the spiral reinforcing structure provides uniform radial support force, effectively disperses pressure during expansion, avoids excessive local pressure, and reduces the risk of damage to the blood vessel wall.

[0016] b. High pressure resistance: the spiral reinforced balloon can withstand higher expansion pressure, especially suitable for dealing with stubborn plaques and highly calcified lesions, ensuring sufficient expansion of the lesion area.

[0017] c. Strong anti-torsion ability: the spiral reinforcing structure improves the anti-torsion ability of the balloon, ensuring stable operation under curved and complex anatomical conditions, and reducing deformation or damage.

[0018] d. Precise positioning: the embedded imaging ring in the balloon allows precise positioning of the balloon position under X-ray, ensuring the accuracy of treatment during surgery.

[0019] e. Flexibility and compliance: despite the addition of the spiral reinforcing structure, the balloon still maintains high flexibility, allowing smooth passage through complex coronary anatomical structures, improving the flexibility of surgical operation.

[0020] f. Reduce surgical risk: by improving the mechanical properties and operation accuracy of the balloon, the risk of balloon rupture and displacement during surgery is significantly reduced, improving the success rate of coronary intervention surgery and patient safety. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 This is a schematic diagram of a spiral-enhanced coronary balloon dilation catheter. Detailed Implementation

[0022] To make this utility model more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0023] This invention provides a spiral-enhanced coronary balloon dilation catheter, such as... Figure 1 As shown, it includes a catheter body 5, which has a guidewire lumen 1 and an filling lumen 2. The guidewire lumen 1 is located in the middle of the catheter body 5 and passes through both ends of the catheter body 5. The filling lumen 2 is located outside the guidewire lumen 1. One end of the filling lumen 2 is connected to a balloon 3, and the other end is located at the proximal end of the catheter body 5. The other end of the filling lumen 2 can be connected to the balloon expansion pressure pump to inject contrast agent. The balloon 3 is located at the distal end of the catheter body 5 near the end. The balloon 3 is fixed on the outer wall of the catheter body 5, and the outer wall of the catheter body 5 has a groove to accommodate the balloon 3. After the balloon 3 is filled with contrast agent, it can protrude from the outer wall of the catheter body 5.

[0024] The surface of the balloon 3 integrates a helical reinforcement structure 4, which protrudes from the surface of the balloon 3. The helical reinforcement structure 4 is made of an elastic material with a certain strength (e.g., MED-4750 silicone rubber). The specific elastic value of the material of the helical reinforcement structure 4 is not limited, as long as it meets the following conditions: the elastic strength of the material of the helical reinforcement structure 4 is less than the elastic strength of the material of the balloon 3, and the helical reinforcement structure 4 is stretched a certain distance by the expansion of the balloon 3, while limiting the external uniformity of the balloon 3 to a certain extent. The helical reinforcement structure 4 has a helical shape and spirals around the surface of the balloon 3 along the length of the catheter body 5. The helical reinforcement structure 4 can provide additional radial support and anti-torsional capacity to ensure uniform pressure distribution during expansion.

[0025] The spiral reinforcement structure 4 adopts a single-layer design, and the pitch can be adjusted according to clinical needs to adapt to different types of vascular lesions, further improving the expansion effect and adaptability of balloon 3.

[0026] The catheter body 5 has a guidewire lumen 1 and a filling lumen 2. The guidewire lumen 1 is used to guide the direction of the catheter's advance in the blood vessel, while the filling lumen 2 is connected to the inside of the balloon 3 and is used to inject or withdraw contrast agent to control the expansion or contraction of the balloon 3.

[0027] A contrast-enhancing ring is embedded on the catheter body 5 within the area covered by the balloon 3, ensuring accurate positioning of the balloon 3 under X-ray and providing precise treatment results. This means it has a contrast-enhancing positioning function.

[0028] The spiral reinforcing structure 4 not only improves the pressure resistance of the balloon 3, but also maintains a certain flexibility, enabling it to smoothly pass through complex coronary artery anatomical structures, with high pressure resistance and flexibility.

[0029] The manufacturing process of the present utility model is as follows:

[0030] a. Material preparation: Select the material for manufacturing the spiral reinforced balloon. The balloon 3 is usually made of nylon, PEBAX, polyethylene terephthalate or polyurethane, with semi-compliance, good passability and fatigue resistance.

[0031] b. Manufacturing of spiral reinforcing structure 4: According to the design requirements, use precision molding equipment to generate spiral reinforcing structure on the outer surface or inside of the balloon 3. The spiral reinforcing structure 4 can adopt a single-layer structure, and the pitch is adjusted according to the needs of different lesion types. Ensure that the spiral reinforcing structure 4 is tightly combined with the surface of the balloon 3, providing uniform radial support force.

[0032] c. Integration of guidewire lumen 1 and inflation lumen 2: The catheter body 5 is composed of multiple layers of material, with a polytetrafluoroethylene lining in the inner layer to ensure smooth passage of the guidewire. The guidewire lumen 1 is provided in the middle of the catheter body 5, and the outer layer is the inflation lumen 2, which is in communication with the inside of the balloon 3, used to inject or extract contrast agent during the operation to control the expansion or contraction of the balloon 3.

[0033] d. Embedding of the developing ring: Embed multiple developing rings in the balloon 3 covering area. The developing ring is made of opaque metal (such as platinum or tungsten), with its axis parallel to the catheter axis. The developing ring ensures accurate display of the balloon position under X-ray, which helps to achieve precise positioning during the operation.

[0034] e. Assembly of the balloon 3: Install the spiral reinforced balloon that has been processed to the outside of the catheter front end, ensuring that the balloon 3 completely covers the catheter. Check the tightness of the catheter and the patency of the guidewire lumen 1 to ensure that it can smoothly pass through the blood vessels and reach the target lesion site.

[0035] f. Testing and quality control: Perform high-pressure expansion test on the assembled spiral reinforced balloon catheter to ensure that it can uniformly expand under high pressure and maintain a stable shape. Perform anti-twist test to ensure that it is not easily deformed or damaged under complex anatomical conditions. Finally, perform developing positioning test to confirm the normal function of the developing ring.

[0036] g. Packaging and sterilization: After all tests are completed, the spiral reinforced balloon catheter is packaged and sterilized using standard medical device sterilization methods (such as ethylene oxide sterilization). The packaging should comply with the relevant specifications of medical devices to ensure that the product is not damaged during transportation and storage.

[0037] h. Method of use: During the actual operation, use vascular intervention techniques to send the guide wire to the target lesion site. Guide the helical reinforced balloon dilation catheter along the guide wire to the lesion, and under X-ray fluoroscopy, observe the positioning of the developing ring and confirm the position of the balloon. Then, inject the developing agent into the inflation lumen to expand the balloon, complete the dilation treatment of the lesion. After dilation is completed, the developing agent is extracted to make the balloon shrink, and the catheter and guide wire are withdrawn.

[0038] The specific method of use of the utility model is as follows:

[0039] a. Preparation: First, confirm the integrity and sealing of the catheter and balloon 3. Check whether the guide wire lumen 1 is unobstructed, and select a guide wire of appropriate size. Select and prepare the balloon dilation pressure pump, and prepare enough developing agent.

[0040] b. Guide wire guidance: Through vascular intervention techniques, insert a guide wire with a diameter of 0.035 inches or less into the coronary artery lesion site of the patient. The guide wire needs to accurately pass through the stenosis or occlusion area and reach the distal end of the target lesion.

[0041] c. Catheter positioning: advance the helical reinforced balloon dilation catheter along the guide wire until the developing ring of the balloon 3 is aligned with the target lesion area under X-ray fluoroscopy. By fine-tuning the catheter position, ensure that the balloon 3 is located in the ideal dilation position.

[0042] d. Balloon 3 expansion: use the balloon dilation pressure pump to inject developing agent into the inflation lumen 2, causing the balloon 3 to gradually expand. Due to the support of the helical reinforcement structure 4, the balloon 3 will uniformly expand, forming a stable expansion shape, and expanding the stenotic blood vessel area. The expansion pressure is gradually increased according to the degree of stubbornness of the lesion, but should avoid exceeding the maximum pressure limit of the balloon 3.

[0043] e. Developing inspection: after dilation is completed, check the effect of balloon 3 expansion through X-ray fluoroscopy. Ensure that the lesion area has been fully expanded and there is no residual stenosis or plaque. If necessary, repeat the expansion or replace a larger size balloon to perform expansion again.

[0044] f. Balloon 3 shrinkage: after expansion is completed and the effect is confirmed, extract the developing agent through the balloon dilation pressure pump to make the balloon quickly shrink. The shrunken balloon 3 will return to a state of being tightly wrapped on the catheter, so that it can be smoothly withdrawn.

[0045] g. Catheter and guide wire withdrawal: fix the guide wire, and slowly withdraw the catheter and shrunken balloon along the guide wire. Confirm that the withdrawal of the balloon and guide wire does not cause vascular damage or other complications.

[0046] h. Postoperative treatment: after the operation, evaluate the blood flow recovery of the expanded area to ensure unobstructed blood flow. After the treatment is completed, according to the operation situation, the patient is given postoperative care and observation.

Claims

1. A spiral-enhanced coronary balloon dilation catheter, comprising a catheter body (5), wherein the catheter body (5) has a guidewire lumen (1) and an filling lumen (2), the guidewire lumen (1) is located in the middle of the catheter body (5) and extends through both ends of the catheter body (5), the filling lumen (2) is located outside the guidewire lumen (1), one end of the filling lumen (2) is connected to a balloon (3), and the other end is located at the proximal end of the catheter body (5), the balloon (3) is located at the distal end of the catheter body (5) near the distal end, and the balloon (3) is fixed to the outer wall of the catheter body (5), characterized in that, The surface of the balloon (3) is provided with a spiral reinforcement structure (4) that protrudes from the surface of the balloon (3); the spiral reinforcement structure (4) is spiral in shape and spirally wraps around the surface of the balloon (3) along the length of the catheter body (5).

2. The spiral-enhanced coronary balloon dilation catheter as described in claim 1, characterized in that, The other end of the filling cavity (2) is connected to a balloon expansion pressure pump that fills the balloon (3) with contrast agent; the outer wall of the catheter body (5) is provided with a groove that can accommodate the balloon (3); after the balloon (3) is filled with contrast agent, the balloon (3) protrudes out of the outer wall of the catheter body (5).

3. The spiral-enhanced coronary balloon dilation catheter as described in claim 1, characterized in that, The elastic strength of the spiral reinforcement structure (4) is less than that of the balloon (3); the spiral reinforcement structure (4) provides radial support and anti-torsion capability to the balloon (3), ensuring that the pressure of the balloon (3) is evenly distributed during expansion.

4. The spiral-enhanced coronary balloon dilation catheter as described in claim 1, characterized in that, A contrast ring is embedded on the catheter body (5) and within the area covered by the balloon (3).

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