Pulmonary artery balloon hemostasis structure
Patent Information
- Application Number
- CN202522225956.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-10-22
- Publication Date
- 2026-09-22
- Estimated Expiration
- 2035-10-22
AI Technical Summary
[0002]早期球囊导管因缺乏X光显影标记(如钽丝环形缠绕结构),在肺动脉分支病变或解剖变异(如主-肺动脉间隔缺损)场景中易发生球囊移位,导致止血失败或二次损伤风险;压力控制方面,传统手动阀无实时压力反馈与锁止机构,充气操作依赖经验判断,压力波动超过30mmHg可能诱发再灌注肺水肿(RPE),且缺乏声光报警等安全预警功能;材料与功能局限表现为球囊生物相容性差、无肝素/聚乙二醇抗凝涂层,易引发血栓栓塞,同时单一止血功能无法满足合并感染或需局部给药患者的需求,缺乏药物输送通道与微型压力传感器集成设计;并发症防控方面,肺动脉出血常伴随肺水肿、喉返神经损伤等风险,传统装置缺乏辅助内管与快速响应机制,在肺动脉总干损伤等紧急情况下易延误救治,鉴于此,针对上述问题深入研究,遂有本案产生
本实用新型提供了一种肺动脉球囊止血结构。具备以下有益效果,该一种肺动脉球囊止血结构,双球囊结构配合X光标记(钽丝环形缠绕)及连接支撑条设计,显著提升肺动脉出血点的精准定位能力,避免因血管迂曲或解剖变异导致的移位风险;棘轮锁止手动阀与双刻度气压表(标示绝对/相对压力值)集成声光报警装置,构建压力安全控制闭环,有效防止充气操作中的压力骤升,降低再灌注肺水肿等并发症风险;医用高弹性硅胶球囊表面复合肝素抗凝层或聚乙二醇亲水层,结合生物相容性涂层工艺,大幅减少术后血栓栓塞概率;辅助内管集成微型压力传感器与药物输送通道,实现止血-监测-治疗的协同功能扩展,满足复杂病例(如合并感染、需局部给药)的临床需求;防滑硅胶套与凸点纹理设计优化操作稳定性,配合棘爪-棘齿锁止机构确保调节把手精准定位不滑脱,整体提升装置在肺动脉高压、主-肺动脉间隔缺损等高风险场景中的临床适用性与安全性。
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Figure CN224776879U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of balloon hemostasis technology, specifically a pulmonary artery balloon hemostasis structure. Background Technology
[0002] Early balloon catheters, lacking X-ray imaging markers (such as tantalum wire loops), were prone to balloon displacement in pulmonary artery branch lesions or anatomical variations (such as aortopulmonary septal defects), leading to hemostasis failure or secondary injury risks. Regarding pressure control, traditional manual valves lacked real-time pressure feedback and locking mechanisms, relying on experience for inflation operation; pressure fluctuations exceeding 30 mmHg could induce reperfusion pulmonary edema (RPE), and they lacked safety warning functions such as audible and visual alarms. Material and functional limitations included poor balloon biocompatibility, lack of heparin / polyethylene glycol anticoagulant coating, and a high risk of thromboembolism. Furthermore, single hemostasis function could not meet the needs of patients with concurrent infections or requiring local drug administration, and there was a lack of integrated drug delivery channels and miniature pressure sensors. In terms of complication prevention, pulmonary hemorrhage is often accompanied by risks such as pulmonary edema and recurrent laryngeal nerve injury; traditional devices lacked auxiliary inner tubes and rapid response mechanisms, easily delaying treatment in emergencies such as pulmonary trunk injury. Therefore, this case study was developed to address these issues. Utility Model Content
[0003] To achieve the above objectives, this utility model provides the following technical solution: a pulmonary artery balloon hemostasis structure, comprising a catheter body, a hemostasis structure mounted on the catheter body, the hemostasis structure comprising an inner insert tube inserted into the inner side of the catheter body, an auxiliary inner tube mounted on the inner side of the catheter body, a plurality of connecting support strips mounted on the inner side of the catheter body, the connecting support strips being connected to the inner insert tube, the auxiliary inner tube being movably positioned between a pair of connecting support strips and the inner insert tube, an external interface mounted on the catheter body, a pressure gauge mounted on the external interface, a manual valve mounted on the pressure gauge, a squeeze-type inflation ball mounted on the manual valve, a pair of balloons mounted on the catheter body, inflation inner tubes mounted on the balloons, and a pair of inflation inner tubes being movably inserted into the external interface and the manual valve.
[0004] Preferably, the manual valve includes a valve body, on which a pair of inlet ports and an air inlet are provided. A pair of ball grooves are provided on the valve body, and a Y-shaped opening is provided on each of the ball grooves. The pair of inlet ports are respectively connected to the pair of ball grooves, and the air inlet is connected to the Y-shaped opening. Inlet sealing balls are installed inside the ball grooves, and air inlets are provided on the inlet sealing balls. A transmission shaft is installed on the pair of inlet sealing balls and the valve body, and an adjustment handle is installed on the transmission shaft.
[0005] Preferably, the balloon is equipped with an X-ray marker.
[0006] Preferably, the balloon is made of medical-grade high-elasticity silicone, and its surface is coated with a biocompatible coating, which is a heparin anticoagulant layer.
[0007] Preferably, the auxiliary inner tube has a built-in miniature pressure sensor.
[0008] Preferably, the adjusting handle of the manual valve is equipped with a ratchet locking mechanism.
[0009] Beneficial effects This invention provides a pulmonary artery balloon hemostasis structure. It offers the following advantages: the dual-balloon structure, combined with X-ray marking (tantalum wire loop winding) and connecting support strips, significantly improves the precise location of pulmonary artery bleeding points, avoiding the risk of displacement due to vascular tortuosity or anatomical variations; the ratchet-locking manual valve and the dual-scale pressure gauge (indicating absolute / relative pressure values) integrate an audible and visual alarm device, forming a closed-loop pressure safety control system, effectively preventing sudden pressure increases during inflation and reducing the risk of complications such as reperfusion pulmonary edema; and the surface of the medical-grade high-elasticity silicone balloon is composited with a heparin anticoagulant layer. Alternatively, a polyethylene glycol hydrophilic layer, combined with a biocompatible coating process, significantly reduces the probability of postoperative thromboembolism; the auxiliary inner tube integrates a miniature pressure sensor and a drug delivery channel, realizing the synergistic expansion of hemostasis-monitoring-treatment functions to meet the clinical needs of complex cases (such as those with concurrent infection or requiring local drug administration); the anti-slip silicone sleeve and convex texture design optimize operational stability, and the pawl-ratchet locking mechanism ensures precise positioning of the adjustment handle without slippage, thus improving the overall clinical applicability and safety of the device in high-risk scenarios such as pulmonary hypertension and aortopulmonary septal defect. Attached Figure Description
[0010] Figure 1 This is a front sectional view of the pulmonary artery balloon hemostasis structure described in this utility model.
[0011] Figure 2 This is a three-dimensional schematic diagram of a pulmonary artery balloon hemostasis structure according to the present invention.
[0012] In the diagram: 1. Catheter body; 2. Inner tube; 3. Auxiliary inner tube; 4. Connecting support bar; 5. External interface; 6. Pressure gauge; 7. Manual valve; 8. Hand-operated inflatable ball; 9. Balloon; 10. Inflatable inner tube; 11. Drainage port; 12. Inflation port; 13. Ball groove; 14. Y-shaped port; 15. Drainage sealing ball; 16. Inflation hole; 17. Conducting shaft. Detailed Implementation
[0013] Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.
[0014] Those skilled in the art should connect all electrical components and their compatible power supplies in this case via wires. Appropriate controllers and encoders should be selected according to the actual situation to meet control requirements. The specific connection and control sequence should refer to the working principle described below, where the electrical components are connected in sequence. The detailed connection methods are well-known in the art. The following mainly introduces the working principle and process, and will not describe the electrical control further.
[0015] Example Please see Figure 1-2 In the field of pulmonary artery interventional therapy, traditional hemostasis devices face multiple technical bottlenecks: early balloon-9 catheters lacked precise positioning markers (such as structures visible on X-ray), making them prone to displacement during the procedure due to vascular tortuosity, thus affecting hemostasis. For example, in pulmonary artery branch lesions, conventional balloon-9 catheters often struggle to accurately anchor the bleeding point due to anatomical variations (such as aortopulmonary septal defects), leading to hemostasis failure or the risk of secondary injury; early balloon-9 materials had poor biocompatibility, easily causing thrombosis; and the lack of an anticoagulant coating (such as heparin / polyethylene glycol) on the surface increased the risk of postoperative embolism. Therefore, this application protects a pulmonary artery balloon 9 hemostasis structure. The catheter body 1 is inserted into the inner side of the pulmonary artery. A pair of balloons 9 on the catheter body 1 are moved to both sides of the bleeding site. By pressing and squeezing the inflation ball 8, the gas drainage manual valve 7 in the inflation ball 8 is squeezed. By adjusting the adjustment handle on the manual valve 7, the transmission shaft 17 on it is driven by the adjustment handle. The transmission shaft 17 drives the drainage sealing ball 15 on it. By changing the angle of the inflation hole 16 on the moving drainage sealing ball 15, the communication relationship between a pair of drainage ports 11 and inflation ports 12 is changed. By squeezing the inflation ball 8, the gas is drained to the drainage ports 11. Through the cooperation of a pair of drainage ports 11 with a pair of inflation inner tubes 10, the balloons 9 are inflated and expanded, thereby expanding and sealing both sides of the arterial bleeding site. In summary, the procedure involves inserting the catheter body 1 into the pulmonary artery and precisely positioning a pair of balloons 9 on either side of the bleeding site. During operation, squeezing the inflation balloon 8 introduces gas into the manual valve 7. Adjusting the handle controls the angle of the inflation port 16 of the drainage sealing balloon 15, changing the connection between the drainage port 11 and the inflation port 12. Gas enters the balloons 9 through the inflation inner tube 10, causing them to inflate and mechanically compress the blood vessels on both sides of the bleeding site, blocking blood flow and achieving hemostasis. Simultaneously, the pressure gauge 6 monitors the pressure in real time to avoid over-inflation. This structure, based on the mechanical compression principle of the balloons 9 and combined with pressure regulation to ensure safe inflation, is widely used clinically in the treatment of stenotic vascular diseases such as chronic thromboembolic pulmonary hypertension (CTEPH)—restoring hemodynamics of the stenotic vessels and reducing pulmonary artery pressure through balloon 9 expansion. However, it is necessary to be wary of complications such as reperfusion pulmonary edema (RPE). The pulmonary edema predictive index (PEPSI) should be used to assess surgical risk, and a gradual expansion strategy should be adopted to reduce the sudden increase in capillary bed pressure and prevent RPE. Different types of balloon 9 (such as single balloon 9, double balloon 9, and Inoue balloon 9) need to be selected according to the patient's vascular anatomy and lesion characteristics to ensure the accuracy and safety of the operation, and ultimately achieve the dual goals of effective hemostasis and blood flow restoration.
[0016] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.
Claims
1. A pulmonary artery balloon (9) hemostatic structure, characterized in that, The catheter includes a catheter body (1), on which a hemostatic structure is installed. The hemostatic structure includes an inner insert (2), which is inserted into the inner side of the catheter body (1). An auxiliary inner tube (3) is installed on the inner side of the catheter body (1). A plurality of connecting support strips (4) are installed on the inner side of the catheter body (1). The connecting support strips (4) are connected to the inner insert (2). The auxiliary inner tube (3) is movably mounted on a pair of the connecting support strips (4). Between the inner insertion tube (2), an external interface (5) is installed on the catheter body (1), a pressure gauge (6) is installed on the external interface (5), a manual valve (7) is installed on the pressure gauge (6), a hand-squeezable inflation ball (8) is installed on the manual valve (7), a pair of balloons (9) are installed on the catheter body (1), and an inflation inner tube (10) is installed on the balloon (9). The pair of inflation inner tubes (10) are movably inserted into the external interface (5) and the manual valve (7).
2. The pulmonary artery balloon (9) hemostasis structure according to claim 1, characterized in that, The manual valve (7) includes a valve body, on which a pair of drain ports (11) and an air inlet (12) are provided. A pair of ball grooves (13) are provided on the valve body. A Y-shaped port (14) is provided on the pair of ball grooves (13). The pair of drain ports (11) are respectively connected to the pair of ball grooves (13). The air inlet (12) is connected to the Y-shaped port (14). A drain sealing ball (15) is installed on the inner side of the ball groove (13). An air inlet (16) is provided on the drain sealing ball (15). A transmission shaft (17) is installed on the pair of drain sealing balls (15) and the valve body. An adjustment handle is installed on the transmission shaft (17).
3. The pulmonary artery balloon (9) hemostasis structure according to claim 2, characterized in that, The balloon (9) is equipped with an X-ray marker.
4. The pulmonary artery balloon (9) hemostasis structure according to claim 3, characterized in that, The balloon (9) is made of medical high-elasticity silicone and its surface is coated with a biocompatible coating, which is a heparin anticoagulant layer.
5. The pulmonary artery balloon (9) hemostasis structure according to claim 4, characterized in that, The auxiliary inner tube (3) has a built-in miniature pressure sensor.
6. The pulmonary artery balloon (9) hemostasis structure according to claim 5, characterized in that, The adjustment handle of the manual valve (7) is equipped with a ratchet locking mechanism.