Low-trauma sheath-free in-aorta balloon catheter

Abstract

The invention provides a low-trauma sheath-free in-aorta balloon catheter, and belongs to the technical field of aorta balloon counterpulsation. Comprising an outer catheter, a main balloon is arranged at the far end of the outer catheter and used for blocking aorta blood flow, and an auxiliary balloon located at the near end of the main balloon is arranged on a catheter body of the outer catheter and used for anchoring the position of the outer catheter when the auxiliary balloon is inflated and expanded. The near end of the outer catheter is provided with a connecting part which is arranged outside the human body and used for sucking, deflating and inflating the main balloon and the auxiliary balloon and allowing a guide wire to penetrate through, an inner tube is arranged in the outer catheter, and an anticoagulant perfusion part is arranged on the outer catheter. A sheathing canal is omitted, direct percutaneous puncture implantation is achieved, blood vessel injury is reduced, through a double-balloon structure, the main balloon is located at the far end of the catheter and used for aorta blood flow blocking, and the auxiliary balloon is located at the near end of the main balloon and can be filled to form an anchoring structure to prevent catheter displacement; and the anticoagulant is conveyed into the aorta from the agent outlet head through the anticoagulant infusion tube, so that the vascular injury and thrombus risk can be effectively reduced.

Description

Technical Field

[0001] The invention provides a low-traumatic sheathless intra-aortic balloon catheter, belonging to the technical field of aortic balloon counterpulsation. Background Art

[0002] Intraaortic balloon pump (IABP) is an interventional therapy that mechanically assists cardiac hemodynamics. It is primarily used in critical conditions such as acute heart failure, cardiogenic shock, and the perioperative period of high-risk cardiac surgery. It works by inflating the balloon during diastole to increase coronary blood flow and deflating it during systole to reduce cardiac afterload, thereby increasing cardiac output and helping patients survive critical periods.

[0003] Existing intra-aortic balloon catheters used for intra-aortic balloon pumping generally meet normal usage requirements, but they still have certain drawbacks: Traditional balloon catheters only achieve hemostasis by physically blocking blood flow and lack active thrombosis prevention mechanisms. Furthermore, traditional catheters require a sheath for placement to prevent catheter migration, increasing the risk of vascular damage and thrombosis. To address these issues, the present invention provides a low-invasive, sheathless intra-aortic balloon catheter. Summary of the Invention

[0004] The technical problem solved by the present invention is: the lack of an active thrombosis prevention mechanism, reliance on sheath placement to prevent catheter displacement, and increased risk of vascular damage and thrombosis.

[0005] In order to solve the technical problem, the technical solution provided by the present invention is: a low-traumatic sheathless intra-aortic balloon catheter, comprising an outer catheter, a main balloon is provided at the distal end of the outer catheter for blocking aortic blood flow, a secondary balloon is provided on the tube body of the outer catheter located at the proximal end of the main balloon, so as to anchor the position of the outer catheter when the secondary balloon is inflated, the proximal end of the outer catheter is provided with a connecting part placed outside the human body for the main balloon and the secondary balloon to be deflated and inflated and for inserting a guide wire, an inner tube is provided in the outer catheter, an anticoagulant perfusion part is provided on the outer catheter, the anticoagulant perfusion part comprises a drug outlet head installed on the tube body of the outer catheter between the main balloon and the secondary balloon, and an anticoagulant perfusion tube is provided in the outer catheter that is connected to the drug outlet head and placed on the outside of the inner tube.

[0006] Furthermore, the connecting portion includes a Y-shaped connector 1 connected to the external catheter, one side interface of the Y-shaped connector 1 is provided with an extracorporeal tube connected to the external catheter, the other side interface of the Y-shaped connector 1 is provided with a Y-shaped connector 2, one side interface of the Y-shaped connector 2 is provided with an anticoagulant connecting pipe connected to the anticoagulant perfusion tube, and the other side interface of the Y-shaped connector 2 is provided with a guide wire inlet connected to the inner tube, which is used to pass the guide wire from the Y-shaped connector 2 and the Y-shaped connector 1 into the inner tube through the guide wire inlet.

[0007] Furthermore, the end of the extracorporeal tube is provided with an electromagnetic valve, which is used to control the connection between the extracorporeal tube and the positive pressure tank or the negative pressure tank, so as to deflate and inflate the main balloon and the auxiliary balloon. A one-way valve is provided on the anticoagulant connecting pipe to prevent backflow.

[0008] Furthermore, the main balloon tip is provided with a hollow tip which is placed at one end of the outer catheter and communicates with the inner tube.

[0009] Furthermore, the main balloon and the auxiliary balloon are both provided with through holes that match the outer catheter, and the surface of the outer catheter is provided with a plurality of air holes that communicate with the main balloon and the auxiliary balloon.

[0010] Furthermore, the outer catheter is made of high molecular weight polyurethane material to reduce platelet adhesion, and the outer surface of the outer catheter is provided with a hydrophilic polymer coating to form a physical barrier to inhibit thrombosis.

[0011] Furthermore, a protective film is provided on the outside of the main balloon and the auxiliary balloon to prevent direct contact with blood and reduce the risk of thrombosis.

[0012] Furthermore, the main balloon and the auxiliary balloon are provided with integrated pressure sensors for real-time monitoring of the abutment pressure.

[0013] The beneficial effects of the present invention are: the sheath is eliminated and the catheter is directly inserted through percutaneous puncture, which reduces vascular damage. Through the double-balloon structure, the main balloon is located at the distal end of the catheter and is used to block the blood flow in the aorta. The secondary balloon is located at the proximal end of the main balloon and can be inflated to form an anchoring structure to prevent the catheter from shifting. Through the anticoagulant perfusion part, the anticoagulant is delivered from the discharge head to the aorta through the anticoagulant perfusion tube, which can more effectively reduce vascular damage and the risk of thrombosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 The figure is a schematic overall plan view of a low-invasive sheathless intra-aortic balloon catheter according to the present invention.

[0015] Figure 2 A partial plan view of a low-invasive sheathless intra-aortic balloon catheter according to the present invention Figure 1 .

[0016] Figure 3 A partial plan view of a low-invasive sheathless intra-aortic balloon catheter according to the present invention Figure 2 .

[0017] 1. External catheter; 2. Main balloon; 3. Secondary balloon; 4. Connecting part; 5. Inner tube; 6. Anticoagulant infusion part; 7. Hollow tip; 10. Air hole; 40. Y-shaped connector 1; 41. Extracorporeal tube; 42. Y-shaped connector 2; 43. Anticoagulant connecting pipe; 44. Guidewire inlet; 45. Solenoid valve; 46. One-way valve; 60. Dispensing head; 61. Anticoagulant infusion tube. DETAILED DESCRIPTION

[0018] The present invention will be further described below with reference to the accompanying drawings.

[0019] According to the attached Figure 1 、 2 3: The present invention provides a low-traumatic sheathless intra-aortic balloon catheter, comprising an outer catheter 1, a main balloon 2 being provided at the distal end of the outer catheter 1 for blocking blood flow in the aorta, a secondary balloon 3 being provided on the body of the outer catheter 1 and being located at the proximal end of the main balloon 2, for anchoring the position of the outer catheter 1 when the secondary balloon 3 is inflated, so as to prevent the outer catheter 1 from shifting, a connecting portion 4 being provided at the proximal end of the outer catheter 1 and being placed outside the human body for deflation and inflation of the main balloon 2 and the secondary balloon 3 and for inserting a guide wire, an inner tube 5 being provided inside the outer catheter 1, an anticoagulant perfusion portion 6 being provided on the outer catheter 1, and the anticoagulant perfusion portion 6 comprising a portion installed on the outer catheter 1 at the main balloon The outer catheter 1 is provided with an anticoagulant perfusion tube 61 which is connected to the dose discharge head 60 and is placed on the outside of the inner tube 5. The connecting part 4 includes a Y-shaped connector 40 which is connected to the outer catheter 1. The other side interface of the Y-shaped connector 40 is provided with a Y-shaped connector 2 42. The one side interface of the Y-shaped connector 2 42 is provided with an anticoagulant connecting pipe 43 which is connected to the anticoagulant perfusion tube 61. A one-way valve 46 is provided on the anticoagulant connecting pipe 43 to prevent backflow. The anticoagulant is injected into the anticoagulant connecting pipe 43 through a syringe and is transported from the dose discharge head 60 to the aorta through the anticoagulant perfusion tube 61 to reduce the risk of thrombosis.

[0020] As the instruction manual Figure 1 、 3As shown: one side interface of the Y-shaped connector 40 is provided with an extracorporeal tube 41 connected to the outer catheter 1, and the other side interface of the Y-shaped connector 2 42 is provided with a guide wire inlet 44 connected to the inner tube 5, which is used to pass the guide wire from the Y-shaped connector 2 42 and the Y-shaped connector 1 40 into the inner tube 5. The end of the extracorporeal tube 41 is provided with a solenoid valve 45, which is used to control the extracorporeal tube 41 to be connected to the positive pressure tank or the negative pressure tank, so as to deflate and inflate the main balloon 2 and the auxiliary balloon 3. The end of the main balloon 2 is provided with a hollow tip 7 placed at one end of the outer catheter 1 and connected to the inner tube 5. The main balloon 2 and the auxiliary balloon 3 are both provided with a through hole that cooperates with the outer catheter 1. Hole, a plurality of air holes 10 connected to the main balloon 2 and the auxiliary balloon 3 are provided on the surface of the tube body of the outer catheter 1. Specifically, a guide wire of appropriate size is passed through the guide wire inlet 44 from the Y-shaped connector 2 42 and the Y-shaped connector 1 40 into the inner tube 5, and finally passes through the hollow tip 7. The guide wire needs to move along the direction of blood flow. When the solenoid valve 45 controls the negative pressure tank to be connected to the extracorporeal tube 41, the negative pressure tank deflates the main balloon 2 and the auxiliary balloon 3 through the outer catheter 1 and the air hole 10. When the solenoid valve 45 controls the positive pressure tank to be connected to the extracorporeal tube 41, the positive pressure tank delivers gas through the outer catheter 1 and the air hole 10 to inflate the main balloon 2 and the auxiliary balloon 3, which can be used to block the aortic blood flow.

[0021] As an optional embodiment, the outer catheter 1 is made of high-molecular polyurethane material to reduce platelet adhesion. The outer surface of the outer catheter 1 is provided with a hydrophilic polymer coating to form a physical barrier to inhibit thrombosis. The main balloon 2 and the auxiliary balloon 3 are provided with a protective film on the outside to block direct contact with blood and reduce the risk of thrombosis. The main balloon 2 and the auxiliary balloon 3 are provided with integrated pressure sensors for real-time monitoring of the contact pressure. The pressure sensor data transmission is transmitted to the external terminal through the built-in wire of the catheter. Specifically, the main balloon 2 and the auxiliary balloon 3 sense the changes in aortic pressure → transmit them to the pressure sensor through the micro-circuit → the control module dynamically adjusts the filling degree of the main balloon 2 and the auxiliary balloon 3 to achieve precise blood flow control of EVAC technology.

[0022] Working principle: When in use, the sheath is eliminated and the catheter is directly inserted through percutaneous puncture. The outer diameter of the catheter is ≤3Fr, and the puncture aperture is reduced by more than 60%, reducing vascular damage. Through the double-balloon structure, the main balloon is located at the distal end of the catheter and is used to block the aortic blood flow. The secondary balloon is located at the proximal end of the main balloon and can be inflated to form an anchoring structure to prevent the catheter from shifting. Through the anticoagulant perfusion part 6, the anticoagulant is injected into the anticoagulant pipe 43 through a syringe, and is delivered to the aorta from the outlet head 60 through the anticoagulant perfusion tube 61, which can more effectively reduce vascular damage and the risk of thrombosis.

[0023] The present invention and its embodiments are described above. This description is not restrictive. The drawings show only one embodiment of the present invention, and the actual structure is not limited thereto. In short, if a person skilled in the art is inspired by this and, without departing from the purpose of the present invention, designs structures and embodiments similar to this technical solution without inventiveness, they shall fall within the scope of protection of the present invention.

Claims

1. A low-invasive sheathless intra-aortic balloon catheter, comprising an outer catheter (1), characterized in that: The distal end of the outer catheter (1) is provided with a main balloon (2) for blocking aortic blood flow, the body of the outer catheter (1) is provided with a secondary balloon (3) located at the proximal end of the main balloon (2), so that the secondary balloon (3) can anchor the position of the outer catheter (1) when it is inflated, the proximal end of the outer catheter (1) is provided with a connecting portion (4) placed outside the human body for the main balloon (2) and the secondary balloon (3) to be deflated and inflated and for inserting a guide wire, an inner tube (5) is provided in the outer catheter (1), an anticoagulant perfusion portion (6) is provided on the outer catheter (1), the anticoagulant perfusion portion (6) includes a drug outlet (60) installed on the body of the outer catheter (1) between the main balloon (2) and the secondary balloon (3), and an anticoagulant perfusion tube (61) is provided in the outer catheter (1) and is connected to the drug outlet (60) and is placed outside the inner tube (5).

2. The low-invasive sheathless intra-aortic balloon catheter according to claim 1, characterized in that: The connecting portion (4) includes a Y-shaped connector 1 (40) connected to the outer catheter (1), a side interface of the Y-shaped connector 1 (40) is provided with an extracorporeal tube (41) connected to the outer catheter (1), and a side interface of the Y-shaped connector 1 (40) is provided with a Y-shaped connector 2 (42), a side interface of the Y-shaped connector 2 (42) is provided with an anticoagulant connecting pipe (43) connected to the anticoagulant perfusion pipe (61), and a side interface of the Y-shaped connector 2 (42) is provided with a guide wire inlet (44) connected to the inner tube (5), for passing the guide wire from the Y-shaped connector 2 (42) and the Y-shaped connector 1 (40) into the inner tube (5) through the guide wire inlet (44).

3. The low-invasive sheathless intra-aortic balloon catheter according to claim 2, characterized in that: The end of the extracorporeal tube (41) is provided with an electromagnetic valve (45), which is used to control the extracorporeal tube (41) to be connected with the positive pressure tank or the negative pressure tank, so as to be used to deflate or inflate the main balloon (2) and the auxiliary balloon (3). The anticoagulant connecting pipe (43) is provided with a one-way valve (46) to prevent backflow.

4. The low-invasive sheathless intra-aortic balloon catheter according to claim 1, characterized in that: The end of the main balloon (2) is provided with a hollow tip (7) which is placed at one end of the outer catheter (1) and is in communication with the inner tube (5).

5. The low-invasive sheathless intra-aortic balloon catheter according to claim 1, characterized in that: The main balloon (2) and the auxiliary balloon (3) are both provided with through holes that match the outer catheter (1), and the surface of the outer catheter (1) is provided with a plurality of air holes (10) that are connected to the main balloon (2) and the auxiliary balloon (3).

6. The low-invasive sheathless intra-aortic balloon catheter according to claim 1, characterized in that: The outer catheter (1) is made of high molecular weight polyurethane material to reduce platelet adhesion, and the outer surface of the outer catheter (1) is provided with a hydrophilic polymer coating to form a physical barrier to inhibit thrombosis.

7. The low-invasive sheathless intra-aortic balloon catheter according to claim 1, characterized in that: The main balloon (2) and the auxiliary balloon (3) are provided with protective films on the outside to prevent direct contact with blood and reduce the risk of thrombosis.

8. The low-invasive sheathless intra-aortic balloon catheter according to claim 1, characterized in that: The main balloon (2) and the auxiliary balloon (3) are provided with integrated pressure sensors for real-time monitoring of the abutment pressure.

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