Ovaloccludus balloon catheter

Abstract

The utility model provides an oval hole frozen closure balloon catheter belongs to medical instrument technical field, its structure includes catheter and frozen ablation air bag, the lead wire approach channel is set up to the centre axis of catheter, and the lead wire approach channel is worn and is connected with the guide wire in, the injection channel along the catheter length direction is set up on the surrounding pipe wall of lead wire approach channel, and the end of injection channel is set up as the blind end in the approach distal end of catheter, the working section fixedly connected with frozen ablation air bag is set up in the approach distal end of catheter, and the injection hole is through between injection channel and outer pipe wall, and the injection hole is connected with the space in frozen ablation air bag and injection channel, the utility model does not have implant, avoids foreign body related complication, promotes the cicatrization closure between the primary septum and secondary septum of the tissue around oval hole through frozen ablation, does not need to implant the occluder, and thoroughly eliminates the risk of metal allergy, thrombosis or material degradation, especially suitable for the patient who is sensitive to foreign body or needs future interventional therapy.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a cryo-closure balloon catheter for the foramen ovale. Background Technology

[0002] Generally, for patients with patent foramen ovale (PFO), the traditional interventional surgery using metallic occluders has limitations that are becoming increasingly apparent, including foreign body residue and complications. Traditional metallic occluders often use nickel-titanium alloy occluders, which need to be permanently left in the body, potentially leading to long-term complications such as thrombosis, metal allergies, and cardiac tissue erosion. Some patients refuse surgery due to allergies or concerns about long-term risks. Furthermore, after the metallic occluder is inserted, it can also affect future interventional procedures in the heart: the metallic occluder may hinder subsequent atrial septal puncture, limiting treatment options.

[0003] Traditional metal occluder intervention requires X-ray guidance, which poses a risk of radiation exposure, especially for adolescents and pregnant women.

[0004] Traditional metal occluder interventions also carry risks of residual shunt or delayed endothelialization, as well as risks of device dislodgement, pericardial effusion, and postoperative complications. Summary of the Invention

[0005] The technical objective of this invention is to overcome the shortcomings of existing technologies and provide a cryo-closure balloon catheter for the foramen ovale.

[0006] The technical solution of this utility model is achieved as follows: the foramen ovale cryo-closure balloon catheter of this utility model includes a catheter and a cryoablation balloon. A guidewire access channel is provided through the central axis of the catheter, and a guidewire is inserted into the guidewire access channel; An injection channel is provided on the wall surrounding the guidewire access channel along the length of the catheter, and the injection channel is set as a blind end at the distal end of the catheter access. At least two injection channels are provided on the catheter wall, and each injection channel is symmetrically distributed around the guidewire entry channel around the central axis. A cryoablation balloon is fixedly connected to the working section at the distal end of the catheter entry. The cryoablation balloon is tubular in the zero-pressure, uninflated state. The two ends of the cryoablation balloon are fixedly connected and airtightly sealed to the outer walls of the two ends of the working section of the catheter. The inner wall of the balloon between the two fixed ends of the cryoablation balloon is free from the outer wall of the working section of the catheter. In the working section of the catheter, there is an injection hole between the injection channel and the outer wall of the catheter, and the injection hole connects the space inside the cryoablation balloon and the injection channel. The end of the catheter's injection channel is connected to an external cryoablation device via an interventional extension tube; The end of the guidewire is connected to the external actuator of the cardiac access system.

[0007] Two injection channels are provided, one of which is set as a cryogenic gas inlet and the other as a cryogenic gas exhaust channel. The cryogenic gas inlet and the cryogenic gas exhaust channel are respectively connected to the gas distribution mechanism of the cryoablation device.

[0008] Multiple injection holes are spaced at equal intervals along the working section of the catheter.

[0009] The cryoablation balloon expands into a flattened ellipsoid when inflated and contracts to fit the working section of the catheter when under zero pressure.

[0010] On the working section of the catheter, multiple injection holes are arranged in different areas: one part is the inlet area for the cryoablation balloon cryo-gas, which is concentrated at the proximal end of the working section of the catheter; the other part is the outlet area for the cryoablation balloon cryo-gas, which is concentrated at the distal end of the working section of the catheter, and an airflow path is formed between the inlet area and the outlet area.

[0011] The application of the aforementioned foramen ovale cryoclosure system in surgical instruments for the treatment of patent foramen ovale.

[0012] The application of the foramen ovale cryoclosure system in cardiac interventional surgical instruments.

[0013] The beneficial effects of this utility model compared with the prior art are: This invention relates to a cryo-closure balloon catheter for the foramen ovale. It is implant-free, avoiding foreign body-related complications. Through cryoablation, it promotes scarring closure between the primary and secondary septa around the foramen ovale. It eliminates the need for implanted occluders, thus completely eliminating the risks of metal allergy, thrombosis, or material degradation. It is especially suitable for patients who are sensitive to foreign bodies or require future interventional treatment.

[0014] This invention employs a minimally invasive design, resulting in less trauma from cryoablation. After intervention in the right atrium via a cardiac intervention system, a cryoablation balloon is inserted into the foramen ovale and inflated with cryo-gas. The balloon directly and instantly freezes and ablates the primary and secondary septa of the foramen ovale. After the system is detached from the heart, the primary and secondary septa heal and close with scarring, resulting in rapid postoperative recovery. This aligns with the trend of minimally invasive surgery with "intervention without implantation."

[0015] This invention induces the natural healing and closure of the primary and secondary septa of the foramen ovale through low temperature, which is closer to the physiological repair process, reduces endothelialization delay, and reduces the risk of residual blood flow shunting.

[0016] This invention provides cryoclosure of the foramen ovale, completely eliminating the need for metal or non-metal occluders and achieving a completely implant-free procedure. The implementation of this invention reduces radiation dependence and maximizes the safety of the surgery and postoperative period.

[0017] This invention targets high-risk patients with patent foramen ovale. Cryoclosure can effectively reduce the risk of embolism, and there is no interference with long-term treatment due to the absence of metal occluders, resulting in superior long-term safety.

[0018] The patent foramen ovale cryoclosure system overcomes traditional technical bottlenecks with its advantages of non-implantation, physiological closure, and low radiation, making it particularly suitable for high-risk patients with patent foramen ovale and individuals sensitive to foreign bodies.

[0019] The foramen ovale cryoclosure balloon catheter of this invention is reasonably designed, simple in structure, safe and reliable, easy to use and maintain, and has great value for widespread application. Attached Figure Description

[0020] Appendix Figure 1 This is a schematic diagram of the structure of this utility model; Appendix Figure 2 This is a schematic diagram of the structure of this utility model; Appendix Figure 3 This is a schematic diagram of the structure of this utility model; Appendix Figure 4 This is a schematic diagram of the structure of this utility model; Appendix Figure 5 This is a schematic diagram of the structure of this utility model; Appendix Figure 6 This is a schematic diagram of the system structure of this utility model.

[0021] The markings in the attached diagram represent: 1. Catheter, 2. Cryoablation balloon, 3. Guide wire access channel; 4. Guide wire; 5. Injection channel; 6. Blind end; 7. Cryoablation of the airbag wall. 8. Injection port 9. Cryoablation device; 10. External actuator for cardiac access system. 11. Refrigeration air inlet duct; 12. Refrigeration air outlet duct. 13. Working section. Detailed Implementation

[0022] The following is a detailed description of the foramen ovale cryo-closure balloon catheter of this utility model, with reference to the accompanying drawings.

[0023] As shown in the attached figure, the foramen ovale cryoclosure system of this invention includes a catheter and a cryoablation balloon. A guidewire access channel is provided through the central axis of the catheter, and a guidewire is inserted into the guidewire access channel; An injection channel is provided on the wall surrounding the guidewire access channel along the length of the catheter, and the injection channel is set as a blind end at the distal end of the catheter access. At least two injection channels are provided on the catheter wall, and each injection channel is symmetrically distributed around the guidewire entry channel around the central axis. A cryoablation balloon is fixedly connected to the working section at the distal end of the catheter entry. The cryoablation balloon is tubular in its uninflated state, with its two ends fixedly connected to the outer walls of the working section of the catheter. The inner wall of the balloon between the two fixed ends is free from the outer wall of the working section of the catheter. In the working section of the catheter, there is an injection hole that runs between the injection channel and the outer wall of the catheter. The injection hole connects the space inside the cryoablation balloon and the injection channel. The end of the catheter's injection channel is connected to an external cryoablation device via an interventional extension tube; The end of the guidewire is connected to the external actuator of the cardiac access system.

[0024] Two injection channels are provided, one of which is set as a cryogenic gas inlet and the other as a cryogenic gas exhaust channel. The cryogenic gas inlet and the cryogenic gas exhaust channel are respectively connected to the gas distribution mechanism of the cryoablation device.

[0025] Multiple injection holes are spaced at equal intervals along the working section of the catheter.

[0026] When inflated, the cryoablation airbag expands into a flattened ellipsoid shape.

[0027] The application of the aforementioned foramen ovale cryoclosure system in surgical instruments for the treatment of patent foramen ovale.

[0028] The application of the foramen ovale cryoclosure system in cardiac interventional surgical instruments.

[0029] This invention relates to a cryoablation balloon catheter for the foramen ovale. First, using an external actuator from a cardiac access system, a guidewire is inserted from the femoral vein into the right atrium and into the foramen ovale. The catheter of this cryoablation system is positioned at the tip of the delivery sheath. The catheter is pushed along the guidewire through the delivery sheath, allowing the uninflated cryoablation balloon to reach the space between the primary and secondary septa of the foramen ovale. Using a cryoablation device, a certain amount of cryogas (-50℃ to -60℃, N2O, helium, or nitrogen) is injected into the cryoablation balloon at the catheter tip, causing the balloon to inflate into a flattened ellipsoid shape. The two sides of the cryoablation balloon make extensive contact with the inner walls of the primary and secondary septa of the foramen ovale, achieving short-term cryoablation. After the inflator is deflated, the cryoablation device uses vacuum to re-evacuate the cryogas, allowing the balloon to warm up. The balloon deflates and naturally withdraws from the catheter, and finally, the guidewire naturally withdraws. The procedure is complete.

[0030] Because the pressure in the left atrium is higher than that in the right atrium, the primary and secondary septa of the foramen ovale adhere and fuse after cryoablation, eventually healing over time and closing the foramen ovale.

[0031] It has a good surgical effect on patent foramen ovale (PFO).

[0032] Cryoablation devices use high-pressure argon or nitrogen to cool the target tissue to -140 to -160°C. After freezing, helium or nitrogen is used to rapidly raise the target tissue from -140°C to +20 to +40°C. This temperature gradient change can cause protein denaturation, cell lysis, and tissue ischemia and necrosis in the target tissue.

[0033] This invention utilizes the cryoablation device to control the temperature of a small amount of cryogas entering the cryoablation balloon at a safe range of -50℃ to -60℃, thereby cryoablating the inner walls of the primary and secondary septa of the foramen ovale. The operation is safe and stable, effectively ensuring a high success rate.

[0034] like Figure 3 As shown, there can be two cryogenic gas inlet channels and two cryogenic gas outlet channels. The cryogenic gas from the two cryogenic gas inlet channels enters the cryoablation balloon from the injection hole at the proximal end of the working section of the conduit. After cryoablation and warming, the gas enters the two cryogenic gas outlet channels through the injection hole at the distal end of the working section of the conduit (as an outlet) and returns to the gas distribution mechanism of the cryoablation device.

Claims

1. A cryo-closure balloon catheter for the foramen ovale, characterized in that... Including catheters and cryoablation balloons, A guidewire access channel is provided through the central axis of the catheter, and a guidewire is inserted into the guidewire access channel; An injection channel is provided on the wall surrounding the guidewire access channel along the length of the catheter, and the injection channel is set as a blind end at the distal end of the catheter access. At least two injection channels are provided on the catheter wall, and each injection channel is symmetrically distributed around the guidewire entry channel around the central axis. A cryoablation balloon is fixedly connected to the working section at the distal end of the catheter entry. The cryoablation balloon is tubular in the zero-pressure, uninflated state. The two ends of the cryoablation balloon are fixedly connected and airtightly sealed to the outer walls of the two ends of the working section of the catheter. The inner wall of the balloon between the two fixed ends of the cryoablation balloon is free from the outer wall of the working section of the catheter. In the working section of the catheter, there is an injection hole between the injection channel and the outer wall of the catheter, and the injection hole connects the space inside the cryoablation balloon and the injection channel. The end of the catheter's injection channel is connected to an external cryoablation device via an interventional extension tube; The end of the guidewire is connected to the external actuator of the cardiac access system.

2. The foramen ovale cryoclosure balloon catheter according to claim 1, characterized in that: Two injection channels are provided, one of which is set as a cryogenic gas inlet and the other as a cryogenic gas exhaust channel. The cryogenic gas inlet and the cryogenic gas exhaust channel are respectively connected to the gas distribution mechanism of the cryoablation device.

3. The foramen ovale cryoclosure balloon catheter according to claim 1, characterized in that: Multiple injection holes are spaced at equal intervals along the working section of the catheter.

4. The foramen ovale cryoclosure balloon catheter according to claim 1, characterized in that: The cryoablation balloon expands into a flattened ellipsoid when inflated and contracts to fit the working section of the catheter when under zero pressure.

5. The foramen ovale cryoclosure balloon catheter according to claim 1, characterized in that: On the working section of the catheter, multiple injection holes are arranged in different areas: one part is the inlet area for the cryoablation balloon cryo-gas, which is concentrated at the proximal end of the working section of the catheter; the other part is the outlet area for the cryoablation balloon cryo-gas, which is concentrated at the distal end of the working section of the catheter, and an airflow path is formed between the inlet area and the outlet area.

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