Integrated puncture hemostasis balloon catheter

Abstract

The integrated puncture hemostasis balloon catheter comprises an inner sheath catheter body and an outer sheath catheter body arranged on the outer side of the inner sheath catheter body in a sleeving mode, the near end of the inner sheath catheter body is fixedly connected with an integrally-formed connecting base, and a hemostasis balloon body capable of being filled is fixedly arranged on the outer side of the far end of the inner sheath catheter body; a sliding locking mechanism used for controlling axial sliding and circumferential locking of the outer sheath catheter relative to the inner sheath catheter is arranged on the connecting base and comprises a Z-shaped sliding rail arranged in the connecting base and a positioning sliding block fixedly connected with the near end of the outer sheath catheter. The positioning sliding block is connected into the Z-shaped sliding rail in a sliding mode. The operation is simplified and the reliability is improved through the integrated structural design and the convenient locking mechanism, the safety blocking time is prolonged and the risk is reduced through pressure real-time monitoring and dynamic liquid path control, and the key and difficult problems of aortic hemorrhage treatment in emergency treatment trauma, battlefield trauma and other scenes are effectively solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an integrated puncture hemostatic balloon catheter. BACKGROUND

[0002] After the end of percutaneous vascular interventional surgery (such as cardiac intervention, peripheral vascular intervention, neural intervention, etc.), effective hemostasis needs to be performed on the arterial puncture point; the traditional manual compression method is time-consuming and labor-intensive, and has a high risk of complications; therefore, vascular occluders and hemostatic balloon catheters and other devices have been widely used; among them, the hemostatic balloon catheter is an effective external compression hemostatic tool, and its basic principle is to fill the balloon in the tissue gap outside the blood vessel puncture, to exert directional and controllable pressure on the blood vessel break from the outside, thereby achieving rapid hemostasis.

[0003] Aortic hemorrhage caused by emergency trauma, battlefield trauma and other scenarios is a key and difficult problem in the field of emergency treatment, and rapid and timely hemostasis is the core and key of the treatment of this type of disease, and is also the bottleneck that needs to be broken through at present; the current clinical treatment methods mainly include traditional open surgery and endovascular surgery, among which endovascular surgery requires multiple independent components such as guide wire, dilator, sheath tube and balloon catheter, which need to be selected and matched according to requirements during operation; the specific process is to complete the guide wire insertion, dilator, sheath tube insertion in turn after puncturing the blood vessel to establish a channel, and finally the balloon catheter is inserted through the sheath tube for subsequent surgical operation, but this operation process has certain defects, not only requires the operator to receive systematic training, but also the whole process is time-consuming, which is difficult to achieve rapid and effective treatment in emergency rescue and special emergency environments such as battlefield; and the traditional resuscitative aortic balloon occlusion is limited by the 30-minute safe occlusion time limit, and can only be used as the last treatment method in clinical application. The method has certain risk hidden dangers, complete blockage can cause ischemia risk, and when the blood pressure of the proximal end above the blockage position rises to ≥180mmHg, the risk of intracranial hemorrhage in patients will increase by 3.7 times, and the absolute value of death will increase by 21%.

[0004] Therefore, an integrated puncture hemostatic balloon catheter is proposed to solve the problems raised in the above. SUMMARY

[0005] The purpose of the present application is to provide an integrated puncture hemostatic balloon catheter to solve the problem of the current treatment method for aortic hemorrhage caused by emergency trauma or battlefield trauma, which is difficult to achieve rapid, safe and effective hemostasis in an emergency environment, whether it is a complex multi-component endovascular surgery or a resuscitative aortic balloon occlusion limited by the safe time limit and blood pressure risk.

[0006] In order to achieve the above object, the application provides the following technical scheme: an integrated puncture hemostasis balloon catheter, comprising an inner sheath catheter and an outer sheath catheter sleeved outside the inner sheath catheter, a one-piece connecting seat fixedly connected to the proximal end of the inner sheath catheter, and a hemostasis balloon body fixedly arranged outside the distal end of the inner sheath catheter and capable of being filled; A sliding locking mechanism for controlling the axial sliding and circumferential locking of the outer sheath catheter relative to the inner sheath catheter is arranged on the connecting seat, the sliding locking mechanism comprising a Z-shaped sliding rail arranged inside the connecting seat and a positioning sliding block fixedly connected to the proximal end of the outer sheath catheter, the positioning sliding block being slidingly connected in the Z-shaped sliding rail; The sliding locking mechanism has at least two locking positions: in a first locking position, the distal end of the outer sheath catheter covers the hemostasis balloon body; in a second locking position, the distal end of the outer sheath catheter is retracted to expose the hemostasis balloon body; An injection channel and a drainage channel communicating with the hemostasis balloon body are arranged inside the inner sheath catheter, one end of each of the injection channel and the drainage channel communicating with an injection pipeline and a drainage pipeline fixedly connected to the connecting seat.

[0007] Preferably, the Z-shaped sliding rail comprises an axial introduction section for axial introduction of the positioning sliding block, and a proximal fixed groove and a distal fixed groove in communication with the axial introduction section and staggered circumferentially, the proximal fixed groove and the distal fixed groove corresponding to the first locking position and the second locking position respectively.

[0008] Preferably, the inside of the connecting seat is arranged with a sheath sliding groove coaxial with the inner sheath catheter, and the proximal end of the outer sheath catheter is slidingly arranged in the sheath sliding groove.

[0009] Preferably, the inner sheath catheter, the connecting seat, the injection pipeline and the drainage pipeline are integrally injection molded as one whole member.

[0010] Preferably, a finger sleeve ring is integrally formed on the connecting seat.

[0011] Preferably, a balloon pressure sensor is further arranged outside the distal end of the inner sheath catheter, the balloon pressure sensor being arranged at one end of the hemostasis balloon body and fixedly connected to the inner sheath catheter.

[0012] Preferably, a drainage valve is arranged inside the drainage pipeline.

[0013] Preferably, a guide wire through hole is arranged in the center of the connecting seat, the guide wire through hole being coaxially and throughly arranged with the lumen of the inner sheath catheter for the guide wire body to pass through.

[0014] Preferably, the injection channel and the drainage channel are micro channels arranged in parallel in the wall of the inner sheath catheter.

[0015] Compared with the prior art, the beneficial effects of the present application are: the integrated puncture hemostasis balloon catheter simplifies the operation and improves the reliability through the integrated structure design and convenient locking mechanism, prolongs the safe blocking time and reduces the risk through real-time pressure monitoring and dynamic liquid path control, effectively solves the key and difficult problems of aortic hemorrhage treatment in emergency trauma, battlefield trauma and other scenes, and the specific contents are as follows: Firstly, the integrated puncture hemostasis balloon catheter simplifies the operation process and improves the structural reliability, effectively adapts to the use requirements of emergency treatment and emergency scenes such as battlefield trauma. Through the structure design of the inner sheath catheter and the connecting seat being integrated, and the injection pipeline, the drainage pipeline and the connecting seat, the inner sheath catheter are integrally injection molded as a whole component, not only the connection nodes between components are reduced, the leakage risk is reduced, but also the selection link of multiple independent components such as guide wire, expansion, sheath tube and balloon catheter in traditional endovascular surgery is avoided; cooperating with the sliding locking mechanism composed of Z-shaped slide rail and positioning slide block arranged on the connecting seat, only through the sliding of the positioning slide block in the Z-shaped slide rail, the quick switching and stable locking of the outer sheath catheter between the first locking position covering the hemostasis balloon body and the second locking position exposing the hemostasis balloon body can be realized, without the need for operators to receive complex system training, which greatly shortens the operation time. In addition, the finger sleeve ring integrally formed on the connecting seat is convenient for the operator to hold and position, and the coaxial through design of the guide wire through hole and the inner sheath catheter lumen ensures the accurate guidance when the guide wire is placed, further improving the operation convenience.

[0016] Secondly, through precise pressure monitoring and flexible liquid path control, the safe blocking time of the hemostasis balloon is effectively prolonged, and the treatment risk is reduced. By arranging the balloon pressure sensor on the outer side of the distal end of the inner sheath catheter and at one end of the hemostasis balloon body, the pressure state of the hemostasis balloon body after inflation can be monitored in real time, providing accurate basis for pressure regulation; cooperating with the independently opened injection channel and drainage channel in the inner sheath catheter, and the liquid discharge valve arranged in the drainage pipeline, the accurate liquid injection and drainage control of the hemostasis balloon body can be realized. When the balloon pressure sensor detects that the blood pressure at the blocking position exceeds the specified value, part of the liquid in the balloon can be discharged through the cooperation of the drainage channel and the liquid discharge valve, so that the hemostasis balloon body shrinks moderately to allow part of the blood to pass through, avoiding the risk of intracranial hemorrhage caused by sudden rise of blood pressure; when the blood pressure returns to the normal range, the liquid in the balloon is supplemented through the injection channel to make the hemostasis balloon body realize complete blockage again. This kind of dynamic regulation mode breaks through the 30-minute safe blocking time limit of traditional resuscitative aortic balloon occlusion, prolongs the effective blocking time to 120 minutes, avoids the risk of ischemia caused by complete blocking, and improves the safety and effectiveness of treatment. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1The structure diagram of the connection seat in the application is shown in the following figure: Figure 2 The structure diagram of the connection seat in the application is shown in the following figure: Figure 3 The structure diagram of the connection seat in the application is shown in the following figure: Figure 4 The structure diagram of the connection seat in the application is shown in the following figure: Figure 5 The structure diagram of the connection seat in the application is shown in the following figure: Figure 4 The structure diagram of the connection seat in the application is shown in the following figure: Figure 6 The structure diagram of the connection seat in the application is shown in the following figure: Figure 2 The structure diagram of the connection seat in the application is shown in the following figure: Figure 7 The structure diagram of the connection seat in the application is shown in the following figure: Figure 3 The structure diagram of the connection seat in the application is shown in the following figure: Figure 8 The structure diagram of the connection seat in the application is shown in the following figure: Figure 3 The structure diagram of the connection seat in the application is shown in the following figure: Figure 9 The structure diagram of the connection seat in the application is shown in the following figure: Figure 4 The structure diagram of the connection seat in the application is shown in the following figure: Figure 10 The structure diagram of the connection seat in the application is shown in the following figure: Figure 5 The structure diagram of the connection seat in the application is shown in the following figure:

[0018] In the figure: 1, inner sheath catheter; 2, balloon pressure sensor; 3, hemostatic balloon body; 4, connection seat; 5, liquid injection pipeline; 6, liquid discharge pipeline; 7, finger sleeve ring; 8, guide wire through hole; 9, guide wire body; 10, liquid injection channel; 11, liquid discharge channel; 12, sheath pipe sliding groove; 13, outer sheath catheter; 14, Z-shaped sliding rail; 1401, axial introduction section; 1402, proximal end fixed groove; 1403, distal end fixed groove; 15, positioning sliding block; 16, liquid leakage valve. DETAILED DESCRIPTION

[0019] The technical solutions in the embodiments of the application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the application. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the application.

[0020] Please refer to Figures 1-10The application provides a technical scheme: an integrated puncture hemostasis balloon catheter mainly composed of core components such as an inner sheath catheter 1, an outer sheath catheter 13, a hemostasis balloon body 3, a connecting seat 4, a sliding locking mechanism, a liquid injection and drainage system, a pressure detection assembly and a guide wire channel, and each component cooperates to realize the functions of accurate hemostasis and dynamic pressure regulation after puncture.

[0021] The inner sheath catheter 1 is made of medical-grade polytetrafluoroethylene material and has good biocompatibility and bending resistance, the inner diameter of the lumen thereof is adapted to the specifications of commonly used guide wires in clinical practice, and the smooth passage of the guide wire is ensured. The outer sheath catheter 13 is sleeved outside the inner sheath catheter 1 and is made of polyurethane material with a slightly lower elastic modulus than the inner sheath catheter 1, which can ensure the structural stability during sliding and avoid scratching the blood vessel wall. The length of the outer sheath catheter 13 is slightly longer than that of the inner sheath catheter 1, and the distal end port thereof is rounded to further improve the safety in use.

[0022] The hemostasis balloon body 3 is made of high-strength nylon elastic film and is fixed to the outer side of the distal end of the inner sheath catheter 1 by heat welding, and the welding position is subjected to sealing detection to ensure no leakage. The hemostasis balloon body 3 is attached to the surface of the inner sheath catheter 1 in the un-inflated state, and becomes a spherical structure after inflation, and the maximum inflation diameter thereof can be designed to be 5-10 mm according to the diameter of the commonly used blood vessels in clinical practice, which is suitable for the hemostasis requirements of different parts.

[0023] A balloon pressure sensor 2 is fixedly arranged on the outer side of the distal end of the inner sheath catheter 1 and the proximal end of the hemostasis balloon body 3, the sensor adopts a miniature piezoresistive structure, is small in size and fast in response, has a detection range of 0-300 mmHg and an accuracy of ±1 mmHg. The balloon pressure sensor 2 is fixedly connected to the inner sheath catheter 1 by medical glue, the sensor lead is integrated in the inner wall of the inner sheath catheter 1 and extends to a signal interface in the connecting seat 4, which is used to be connected with an external monitoring device to realize real-time acquisition and display of blood pressure.

[0024] The connecting seat 4 and the inner sheath catheter 1 are made by integral injection molding process, and the injection molding material is medical-grade ABS resin, which ensures the structural strength and facilitates processing and molding. The connecting seat 4 integrally forms a liquid injection pipeline 5, a liquid drainage pipeline 6 and a finger sleeve ring 7, wherein the inner diameter of the finger sleeve ring 7 is designed to be 20 mm, which is suitable for the fingers of medical staff to operate and hold the catheter for positioning and adjustment. The ports of the liquid injection pipeline 5 and the liquid drainage pipeline 6 are provided with standard luer connectors, which can be quickly connected with commonly used syringes or infusion devices in clinical practice.

[0025] The sliding locking mechanism is arranged inside the connecting seat 4, and is used for realizing axial sliding and circumferential locking of the outer sheath catheter 13 relative to the inner sheath catheter 1, and the core thereof comprises a Z-shaped sliding rail 14 and a positioning sliding block 15. The Z-shaped sliding rail 14 is arranged on the side wall of a sheath sliding groove 12 inside the connecting seat 4, the sheath sliding groove 12 is coaxially arranged with the inner sheath catheter 1, and the inner diameter of the sheath sliding groove 12 is slightly larger than the outer diameter of the outer sheath catheter 13, so that the proximal end of the outer sheath catheter 13 can smoothly slide in the groove.

[0026] The Z-shaped sliding rail 14 specifically comprises an axial leading-in section 1401, a proximal end fixing groove 1402 and a distal end fixing groove 1403, wherein the axial leading-in section 1401 is arranged in the axial direction of the connecting seat 4, and is used for axially leading in the positioning sliding block 15; the proximal end fixing groove 1402 and the distal end fixing groove 1403 are respectively communicated with the proximal end and the distal end of the axial leading-in section 1401, and are arranged at an angle of 90° in the circumferential direction, the groove depth is 3 mm, and the groove width is matched with the positioning sliding block 15, so that the positioning sliding block 15 cannot axially move after being clamped.

[0027] The inner wall of the inner sheath catheter 1 is parallelly provided with an injection channel 10 and a drainage channel 11, both of which have an inner diameter of 0.8 mm, are formed by laser drilling process, and are smooth without burrs, so that the liquid flow resistance is not too large. One end of the injection channel 10 is communicated with the inside of the hemostatic balloon body 3, and the other end is communicated with the injection pipeline 5 on the connecting seat 4; one end of the drainage channel 11 is also communicated with the inside of the hemostatic balloon body 3, and the other end is communicated with the drainage pipeline 6, so as to form independent injection and drainage circuits.

[0028] The drainage pipeline 6 is provided with a liquid discharge valve 16, which is a one-way pressure regulating valve structure, and the opening pressure thereof can be preset to 120-160 mmHg according to clinical requirements (the specific value can be adjusted by the valve spring pre-tightening force), when the pressure in the hemostatic balloon body 3 exceeds the preset value, the liquid discharge valve 16 is automatically opened to discharge liquid and reduce pressure, and when the pressure is reduced to below the preset value, the liquid discharge valve 16 is automatically closed, so as to realize dynamic adjustment of the pressure.

[0029] A guide wire through hole 8 is arranged in the center of the connecting seat 4, the guide wire through hole 8 is coaxially communicated with the lumen of the inner sheath catheter 1, and has an inner diameter of 1.2 mm, so that the guide wire body 9 with a diameter of 0.035 inch can smoothly pass through the guide wire through hole 8, and a guide wire leading-in flared mouth is arranged at the proximal end of the guide wire through hole 8, so as to facilitate insertion of the guide wire.

[0030] Working principle: Before using the integrated puncture hemostatic balloon catheter, the overall device needs to be checked to determine whether it can work normally, and the guide wire is inserted into the guide wire through hole 8 of the connecting seat 4 according to the clinical requirements. Figure 1 Figure 10 ​As shown, first, the tightness of each component is checked before the operation. The positioning slider 15 of the outer sheath catheter 13 is pushed into the axial introduction section 1401 of the Z-shaped slide rail 14 and rotated to the proximal fixed groove 1402. At this time, the sliding locking mechanism is in the first locking position, the distal end of the outer sheath catheter 13 completely covers the hemostatic balloon body 3, and the balloon is prevented from being damaged or contaminated during the puncture process. The guide wire body 9 is sequentially inserted through the guide wire through hole 8 of the connecting seat 4 and the lumen of the inner sheath catheter 1, and the distal end of the catheter is sent to the puncture hemostasis site through the guide wire guide. The connecting seat 4 is held by the finger sleeve ring 7 for accurate positioning.

[0031] After positioning, the medical staff holds the proximal end of the outer sheath catheter 13 and rotates it counterclockwise by 90°, so that the positioning slider 15 is detached from the proximal fixed groove 1402 to the axial introduction section 1401. Then the outer sheath catheter 13 is pulled proximally until the positioning slider 15 slides to the distal end of the axial introduction section 1401, and then it is rotated clockwise by 90° and locked into the distal fixed groove 1403. At this time, the sliding locking mechanism is switched to the second locking position, and the hemostatic balloon body 3 is completely exposed outside the distal end of the outer sheath catheter 13. The injection pipe 5 is connected to the syringe, and physiological saline is slowly injected into the hemostatic balloon body 3 until the balloon is filled to the preset initial pressure (usually 80-100 mmHg), achieving preliminary plugging of the puncture site.

[0032] After the initial plugging of the balloon, the balloon pressure sensor 2 collects the intravascular pressure signal near the puncture site in real time and transmits the signal to the external monitoring device. The medical staff can observe the blood pressure change in real time through the device. When the blood pressure is monitored to exceed the preset threshold (such as 140 mmHg), the drainage valve 16 in the drainage pipe 6 is automatically opened, the physiological saline in the hemostatic balloon body 3 is discharged through the drainage channel 11 and the drainage pipe 6, the balloon volume is appropriately contracted, and part of the blood flow can normally flow, and the blood pressure gradually decreases. When the blood pressure drops to the normal range (such as 90-130 mmHg), the drainage valve 16 is automatically closed, and the medical staff can supplement the physiological saline through the injection pipe 5 to make the hemostatic balloon body 3 re-inflate to the preset plugging pressure, and restore the complete plugging state. Through the above-mentioned "pressure overrun - partial pressure relief - pressure recovery - re-plugging" dynamic adjustment process, the problem of tissue ischemia caused by long-term complete plugging can be effectively avoided, and the effective blocking time is prolonged from the traditional 30 minutes to 120 minutes.

[0033] After the hemostasis is completed (usually within 120 minutes or according to clinical judgment), the physiological saline in the hemostatic balloon body 3 is completely discharged through the drainage pipe 6 to restore the balloon to the fitted state. Then the positioning slider 15 of the outer sheath catheter 13 is detached from the distal fixed groove 1403, pushed to the proximal end along the axial introduction section 1401, and rotated to lock, so that the outer sheath catheter 13 re-covers the hemostatic balloon body 3. Finally, the entire catheter is slowly withdrawn along the aorta to complete the hemostasis operation.

[0034] Although the present application has been described in detail with reference to the foregoing embodiments, the technical solutions recorded in the foregoing embodiments can be modified, or some of the technical features can be replaced by equivalent features, by those skilled in the art, any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An integrated puncture hemostatic balloon catheter, comprising an inner sheath catheter (1) and an outer sheath catheter (13) sleeved outside the inner sheath catheter (1), characterized in that, The proximal end of the inner sheath catheter (1) is fixedly connected with an integrally formed connecting seat (4), and the distal end of the inner sheath catheter (1) is fixedly provided with an inflatable hemostatic balloon body (3). The connecting seat (4) is provided with a sliding and locking mechanism for controlling the axial sliding and circumferential locking of the outer sheath catheter (13) relative to the inner sheath catheter (1), the sliding and locking mechanism comprises a Z-shaped sliding rail (14) formed in the inner part of the connecting seat (4) and a positioning sliding block (15) fixedly connected with the proximal end of the outer sheath catheter (13), and the positioning sliding block (15) is slidingly connected in the Z-shaped sliding rail (14). The sliding and locking mechanism has at least two locking positions: in the first locking position, the distal end of the outer sheath catheter (13) covers the hemostatic balloon body (3); in the second locking position, the distal end of the outer sheath catheter (13) is retracted to expose the hemostatic balloon body (3). The inner part of the inner sheath catheter (1) is formed with a liquid injection channel (10) and a liquid discharge channel (11) which are in communication with the hemostatic balloon body (3), and one end of each of the liquid injection channel (10) and the liquid discharge channel (11) is in communication with a liquid injection pipeline (5) and a liquid discharge pipeline (6) which are fixedly connected to the connecting seat (4).

2. The one-piece puncture hemostatic balloon catheter of claim 1, wherein: The Z-shaped sliding rail (14) comprises an axial introduction section (1401) for axial introduction of the positioning sliding block (15), and a proximal end fixed groove (1402) and a distal end fixed groove (1403) which are in communication with the axial introduction section (1401) and are circumferentially staggered, and the proximal end fixed groove (1402) and the distal end fixed groove (1403) correspond to the first locking position and the second locking position respectively.

3. The monolithic puncture hemostatic balloon catheter of claim 2, wherein: The inner part of the connecting seat (4) is formed with a sheath tube sliding groove (12) which is coaxial with the inner sheath catheter (1), and the proximal end of the outer sheath catheter (13) is slidingly arranged in the sheath tube sliding groove (12).

4. The monolithic puncture hemostatic balloon catheter of claim 1, wherein: The inner sheath catheter (1), the connecting seat (4), the liquid injection pipeline (5) and the liquid discharge pipeline (6) are integrally injection molded as one whole member.

5. The monolithic puncture hemostatic balloon catheter of claim 4, wherein: The connecting seat (4) is further integrally formed with a finger sleeve ring (7).

6. The one-piece puncture hemostatic balloon catheter of claim 1, wherein: The distal end of the inner sheath catheter (1) is further provided with a balloon pressure sensor (2), and the balloon pressure sensor (2) is arranged at one end of the hemostatic balloon body (3) and is fixedly connected with the inner sheath catheter (1).

7. The one-piece puncture hemostasis balloon catheter of claim 1, wherein: The inner part of the liquid discharge pipeline (6) is provided with a liquid discharge valve (16).

8. The one-piece puncture hemostatic balloon catheter of claim 1, wherein: A guide wire through hole (8) is formed in the center of the connecting seat (4), the guide wire through hole (8) is coaxially through the lumen of the inner sheath catheter (1), and is used for passing a guide wire body (9) therethrough.

9. The one-piece puncture hemostasis balloon catheter of claim 1, wherein: The liquid injection channel (10) and the liquid discharge channel (11) are micro channels which are parallelly formed in the tube wall of the inner sheath catheter (1).

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