Intermittent occlusion balloon catheter system for treating heart failure

Abstract

The invention discloses an intermittent occlusion balloon catheter system for treating heart failure. The system comprises a five-cavity double-balloon catheter, the five-cavity double-balloon catheter comprises a cavity tube body, a first balloon arranged in a pulmonary artery and a second balloon arranged in a superior vena cava, and the first balloon and the second balloon are both fixed to the surface of the cavity tube body; a round head is arranged at the far end of the cavity tube body, and the diameter of the round head is not larger than the outer diameter of the catheter. The near end is connected with the extension tube assembly through an injection molding head; the cavity tube body is provided with five cavity channels which are respectively communicated with the first balloon extension tube, the second balloon extension tube, the thermistor extension tube, the far-end extension tube and the near-end extension tube; the injection pump is driven by the stepping motor, and the controller adjusts the advancing and retreating motion period of the stepping motor, so that the injection pump is controlled to charge and discharge liquid to the second balloon. By intermittently blocking the superior vena cava, the heart filling pressure is reduced, and therefore heart hyperemia and volume overload are prevented.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and particularly relates to an intermittent occlusion balloon catheter system for treating heart failure. BACKGROUND

[0002] Heart failure is the ultimate end of heart diseases, which has the characteristics of high morbidity, high mortality, high re-hospitalization rate, and has become the most important cardiovascular disease in the 21st century. Without heart transplantation, it is difficult for heart failure patients to achieve long-term prognosis, and drug treatment can only play a role in alleviating symptoms.

[0003] Heart failure can be caused by ischemic heart disease, hypertension, valvular heart disease, infection, genetic cardiomyopathy or pulmonary hypertension. Heart failure can also occur without a clear diagnosis, also known as idiopathic cardiomyopathy. Although the heart can initially successfully respond to the increased load caused by hypertension or loss of contractile tissue, over time, this stress leads to compensatory hypertrophy of cardiomyocytes and ventricular wall remodeling. This often leads to overwork of the myocardium, making the myocardium of the damaged area gradually thin, enlarge and further overload. At the same time, the ejection fraction of the damaged ventricle decreases, leading to a decrease in cardiac output and an increase in the average pressure and volume of the ventricle throughout the cardiac cycle, which is a hallmark of heart failure.

[0004] Reducing cardiac preload is the cornerstone of heart failure treatment. Existing methods to reduce cardiac filling pressure include diuretics, ultrafiltration, and vasodilator therapy. These treatments do not provide clear clinical benefits and can cause worsening renal function or hypotension. However, there is currently no medical device that reduces preload to limit the progression of heart failure. Therefore, a new method of rapidly and safely reducing cardiac filling pressure can improve patient symptoms and shorten hospital stays and reduce cardiac overload, thereby limiting the progression of heart failure.

[0005] Since cardiac preload is controlled by venous return through the inferior vena cava or superior vena cava, an intermittent occlusion balloon catheter system for treating heart failure is designed in the present application and implanted in the superior vena cava to play the role of intermittent occlusion of the superior vena cava, so that the device system can prevent or reverse cardiac remodeling that leads to a series of effects associated with the disease. SUMMARY

[0006] The purpose of the present application is to provide an intermittent occlusion balloon catheter system for treating heart failure, which can achieve the effect of intermittent occlusion of the superior vena cava of heart failure patients, thereby reducing cardiac load and filling pressure, and thereby treating acute decompensated heart failure.

[0007] In order to achieve the above-mentioned purpose, the present application adopts the following technical solutions:

[0008] An intermittent occlusion balloon catheter system for treating heart failure, the system comprising a five-lumen double balloon catheter, the five-lumen double balloon catheter comprising a lumen body, a first balloon arranged in a pulmonary artery and a second balloon arranged in a superior vena cava, the first balloon and the second balloon are both fixed to the surface of the lumen body; the distal end of the lumen body is provided with a round head, and the diameter of the round head is not greater than the outer diameter of the catheter; the proximal end is connected with an extension tube assembly through an injection head; the lumen body is provided with five lumen channels, and is in communication with a first balloon extension tube, a second balloon extension tube, a thermistor extension tube, a distal end extension tube and a proximal end extension tube respectively; the injection pump is driven by a stepping motor, and the controller adjusts the movement cycle of the stepping motor to forward and backward, so as to control the injection pump to charge and discharge liquid for the second balloon.

[0009] According to an aspect of the present application, the lumen body is provided with five lumen channels, which are respectively connected to a distal end outflow hole, a proximal end outflow hole, a thermistor mounting hole, a second balloon liquid hole and a first balloon gas hole arranged at different circumferential positions of the lumen body, and then communicated with the corresponding extension tube.

[0010] According to an aspect of the present application, the outer diameter of the five-lumen double balloon catheter is in the range of 2.3-3mm, the cross-sectional shape of the five lumen channels can be circular, elliptical or crescent, preferably circular; the diameters of the proximal end lumen channel and the distal end lumen channel are equal and maximum, and the diameter of the second balloon lumen channel is greater than that of the first balloon lumen channel.

[0011] According to an aspect of the present application, the length of the lumen body is in the range of 1100-1200mm, and black scale lines are arranged on the surface of the lumen body every 100mm along the length direction.

[0012] According to an aspect of the present application, the distal end outflow hole is arranged at the round head, the distance between the first balloon gas hole and the distal end outflow hole is 6-7mm; the distance between the thermistor mounting hole and the distal end outflow hole is 30-40mm; the distance between the proximal end outflow hole and the distal end outflow hole is 290-300mm; the distance between the second balloon liquid hole and the distal end outflow hole is 340-350mm.

[0013] According to an aspect of the present application, the first balloon is fixed at the first balloon gas hole and can cover the round head after inflation; the second balloon is fixed at the second balloon liquid hole, and the fixing mode of the balloon is preferably adhesion.

[0014] According to an aspect of the present application, the material of the first balloon is latex or modified silicone rubber, and the maximum diameter after inflation is in the range of 12-13mm; the material of the second balloon is non-compliant material, and the diameter after inflation is in the range of 26-30mm.

[0015] According to an aspect of the present application, the cavity tube body is made of medical polymer material, such as polyvinyl chloride; the injection head is made of polyethylene material and is provided with a suture ring groove for fixing the position of the five-cavity double-balloon catheter in clinic.

[0016] According to an aspect of the present application, the injection pump mainly comprises a lead screw stepping motor, a clamp assembly, a sliding block, a mounting frame and a medical syringe. The medical syringe is selected from 10-20 mL specifications.

[0017] According to an aspect of the present application, the controller is provided with the functions of adjusting the motion law of the sliding block module in the injection pump, measuring the temperature of the thermistor and the blood pressure.

[0018] The present application has the following advantages:

[0019] The present application provides an intermittent occlusion balloon catheter system for treating heart failure, which adjusts the flow of venous blood returning to the ventricle by intermittent expansion of the balloon in the superior vena cava, and reduces the heart load and pulmonary artery pressure without increasing the renal vein pressure. At the same time, the venous regulation principle of the superior vena cava can also reduce the left ventricular end-diastolic pressure, left ventricular end-diastolic volume and other parameters, thereby reversing ventricular myocardial remodeling. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 Final effect diagram for clinical implantation of the intermittent occlusion balloon catheter system.

[0021] Figure 2 Structural diagram of the five-cavity double-balloon catheter in the balloon deflated (non-working condition) state.

[0022] Figure 3 Structural diagram of the five-cavity double-balloon catheter in the balloon inflated (working condition) state.

[0023] Figure 4 Structural diagram of the round head portion of the cavity tube body.

[0024] Figure 5 Positioning diagram of the cavity tube body. Figure 3 Cross-sectional view of the cavity tube body in position 1-1.

[0025] Figure 6 Diagram showing the positions of the openings on the cavity tube body.

[0026] Figure 7 Diagram showing the positional relationship of the openings on the cavity tube body.

[0027] Figure 8 Structural diagram of the first balloon and the second balloon.

[0028] Figure 9 Structure diagram of injection head.

[0029] Figure 10 Structure diagram of injection pump.

[0030] Figure 11 Structure diagram of installation of thermistor in cavity. DETAILED DESCRIPTION

[0031] The application will be further described below in conjunction with the drawings and specific embodiments. It should be noted that these embodiments are only used to illustrate the application and not to limit the scope of the application.

[0032] As Figures 1 to 10 shown, the application discloses an intermittent occlusion balloon catheter system for treating heart failure, comprising a five-lumen double balloon catheter 1, the five-lumen double balloon catheter 1 comprising a first balloon 13 placed in a pulmonary artery PA and a second balloon 14 placed in a superior vena cava SVC. The five-lumen double balloon catheter 1 further comprises a lumen body 11, an injection head 12 and an extension tube assembly 15. The first balloon 13 and the second balloon 14 are fixed on the surface of the lumen body 11, and the lumen body 11 is connected to the extension tube assembly 15 through the injection head 12. In the present application, it is particularly pointed out that "distal end" refers to the direction close to the first balloon 13, and "proximal end" refers to the direction close to the injection head 12.

[0033] As Figure 2 and Figure 3 shown, the first balloon 13 and the second balloon 14 of the five-lumen double balloon catheter 1 are in a contracted state and closely adhere to the surface of the lumen body 11 in a non-working state. In a clinical implantation operation, the five-lumen double balloon catheter 1 is implanted into the patient's body in a non-working state through the skin, and the implantation position can be selected through the patient's left subclavian vein. Figure 3 As Figure 1 shown, the surface of the lumen body 11 close to the proximal end of the injection head 12 of the five-lumen double balloon catheter 1 can be coated or impregnated with an antibacterial agent, so that the five-lumen double balloon catheter 1 can be used for a long time, while reducing the risk of infection at the percutaneous passage part of the five-lumen double balloon catheter 1; in addition, the whole five-lumen double balloon catheter 1 can be treated with an anticoagulant coating, which can be heparin or other means. The specific implantation effect of the present application is shown in Figure 1 shown, the first balloon 13 passes through the superior vena cava SVC, the right atrium RA, the right ventricle RV and is placed in the left or right pulmonary artery PA in sequence, and at the same time the second balloon 14 is located in the superior vena cava SVC; wherein the first balloon 13 and the second balloon 14 are respectively placed in the pulmonary artery PA and the superior vena cava SVC and then inflated to reach the working state. As Figure 4As shown, in order to prevent the five-cavity double-balloon catheter 1 from causing mechanical damage to the blood vessel wall, valve or other ventricular structure during implantation in the human body, a round head 112 is provided at the distal end of the cavity tube body 11, and the diameter of the round head is not greater than the outer diameter of the cavity tube body 11. When the five-cavity double-balloon catheter 1 is implanted in the human body and fixed in position, the injection pump 2 and the controller 3 are connected through the extension tube assembly 15.

[0034] In the present application, in order to facilitate the percutaneous implantation of the five-cavity double-balloon catheter 1 into the blood vessel, the outer diameter of the cavity tube body 11 is controlled to be between 2.3-3.0mm, and the total length of the cavity tube body 11 is set to be in the range of 1100-1200mm. As shown in the figure, Figure 5 As shown, the cross section 1-1 of the cavity tube body 11 contains five cavities that are not connected to each other, specifically the distal end cavity A, the proximal end cavity B, the thermistor cavity C, the second balloon cavity D and the first balloon cavity E; among them, the cross-sectional shape of the five cavities can be circular, elliptical or crescent, and in the example of the present application, the circular shape is preferred for easy processing. The diameters of the proximal end cavity A and the distal end cavity B are equal and the largest, with a diameter in the range of 0.9-1.0mm; the diameter of the second balloon cavity D is greater than that of the first balloon cavity E, but both are smaller than the diameters of the proximal end cavity A and the distal end cavity B; at the same time, the diameter of the thermistor cavity C is controlled to be in the range of 0.7-0.8mm. In combination with Figure 3 As shown, the five cavities are in communication with the extension tube assembly 15 at the proximal end, and the corresponding relationship between the cavities and the extension tubes is as follows: distal end cavity A-distal end extension tube 152, proximal end cavity B-proximal end extension tube 154, thermistor cavity C-thermistor extension tube 153, second balloon cavity D-second balloon extension tube 151 and first balloon cavity E-first balloon extension tube 155. Among them, the extension tube assembly 15 is made of tubes with the same outer diameter, different colors and different lengths, which is convenient for clinicians to use and functionally distinguish. At the same time, the ends of the second balloon extension tube 151, the distal end extension tube 152, the proximal end extension tube 154 and the first balloon extension tube 155 are all connected with standard luer female connectors. In combination with Figure 1 As shown, the second balloon extension tube 151 is connected with the injection pump 2, the distal end extension tube 152, the thermistor extension tube 153 and the proximal end extension tube 154 are all connected with the controller 3, and the first balloon extension tube 155 is connected with a standard medical syringe for use (which is a standard part and not listed in the figure). Among them, the gas used to inflate the first balloon 13 is air, and the maximum volume of air injection is 1.5mL. In the present application, in order to measure the blood pressure, the distal end extension tube 152 and the proximal end extension tube 154 are connected with the controller through a disposable medical invasive pressure sensor (which is a standard part and not listed in the figure).

[0035] In combination with Figure 6 ( Figure 6 a- Figure 6 d) andFigure 7 As shown, five small holes are provided on the cavity tube body 11 in the circumferential direction, which are a distal outlet hole a, a proximal outlet hole b, a thermistor mounting hole c, a second balloon liquid hole d and a first balloon gas hole e. Among them, the distal cavity A, the proximal cavity B, the thermistor cavity C, the second balloon cavity D and the first balloon cavity E respectively lead to the distal outlet hole a, the proximal outlet hole b, the thermistor mounting hole c, the second balloon liquid hole d and the first balloon gas hole e in the distal direction. In the present application, there is a certain distance between the five small holes provided on the cavity tube body 11. As shown, Figure 7 As shown, taking the round head 112 as the starting point, the distal outlet hole a is provided at the center of the end face of the round head 112, the first balloon gas hole e is spaced apart from the distal outlet hole a by a distance of 6-7mm; the thermistor mounting hole c is spaced apart from the distal outlet hole a by a distance of 30-40mm; the proximal outlet hole b is spaced apart from the distal outlet hole a by a distance of 290-300mm; the second balloon liquid hole d is spaced apart from the distal outlet hole a by a distance of 340-350mm.

[0036] As shown, Figure 3 and Figure 8 As shown, the first balloon 13 is made of medical latex or medical modified silicone material, and the second balloon 14 is made of non-compliant or semi-compliant material; at the same time, the cavity tube body 11 is made of medical polymer material, such as polyvinyl chloride, nylon, polyurethane, etc. The first balloon 13 and the second balloon 14 are respectively fixed on the surface of the cavity tube body 11 through the first balloon interface 131 and the second balloon interface 141, and the connection mode is preferably the bonding process with biocompatible glue. Of course, other ways can be selected as long as the balloon is airtight and does not leak. At the same time, the first balloon 13 covers the first balloon gas hole e, and the second balloon 14 covers the second balloon liquid hole d. The maximum size range of the first balloon 13 after expansion is 12-13mm, and the maximum size range of the second balloon 14 after expansion is 26-30mm. As shown, Figure 3 As shown, the first balloon 13 after expansion can cover the round head 112 for the best effect. As shown, Figure 3 and 9 As shown, the injection head 12 is made of medical polyethylene or other medical polymer materials, and is provided with a suture ring groove 121 for fixing the position of the five-cavity double-balloon catheter 1 in the clinic.

[0037] In the present application, the specific process of implanting the five-lumen double-balloon catheter 1 into the human body is as follows: first, a guide wire (a medical surgical accessory, not shown in the figure) is inserted into the left subclavian vein LSCV of the patient and guided to the pulmonary artery PA based on ultrasound imaging technology; second, a tearable sheath tube with a hemostatic valve (a medical surgical accessory, not shown in the figure) is inserted along the guide wire to dilate the vascular access, and the distal outlet hole a of the five-lumen double-balloon catheter 1 is inserted into the guide wire; finally, the first balloon 13 and the second balloon 14 of the five-lumen double-balloon catheter 1 reach the positions as shown in Figure 1 , the guide wire and the tearable sheath tube are removed.

[0038] As shown in Figure 10 , the structure of the injection pump 2 includes a stepping motor 21, a transmission screw rod 22, a front fixed frame 23, a base 24, a rear fixed frame 25, a slider module 26, a clamp rear back plate 27, a clamp front cover plate 28, a bearing 29, a medical syringe 210, and a piston 211. Among them, the medical syringe 210 is selected to have a range of 10-20 mL. The slider module 26 is provided on the transmission screw rod 22, and the clamp rear back plate 27 and the clamp front cover plate 28 are fixedly installed on the upper surface of the slider module 26. The medical syringe 210 and the piston 211 are fixedly installed in the front fixed frame 23 and the slider module 26, respectively. The working principle of the injection pump 2 is that the stepping motor 21 drives the transmission screw rod 22 to rotate, so that the slider module 26 moves linearly along the transmission screw rod 22, and then drives the piston 211 to move forward or backward. Before use, the medical syringe 210 needs to be filled with the liquid to be delivered, and the liquid is preferably physiological saline contrast medium, and the pressure range of the delivered liquid is 50-60 kPa. The forward movement of the slider module 26 in the injection pump 2 is the process of injecting the delivery liquid into the second balloon 14 (the required delivery liquid flows into the second balloon through the second balloon extension tube 151, passes through the second balloon lumen D, and finally flows out from the second balloon liquid hole d), which makes the second balloon 14 expand and become larger; on the contrary, the backward movement of the slider module 26 in the injection pump 2 is the process of emptying the delivery liquid from the second balloon 14, which makes the second balloon 14 shrink and become smaller. The forward and backward movement of the slider module 26 is controlled by the controller 3, that is, the inflation-shrinkage time of the second balloon 14 is controlled, so that the second balloon 14 intermittently expands and shrinks in the superior vena cava SVC. In the present application, the inflation duration of the second balloon 14 is at least 4 times longer than the shrinkage duration of the second balloon 14. For example, the inflation duration of the second balloon 14 can be 5 minutes, and the shrinkage duration of the second balloon 14 is 30 seconds.

[0039] As shown in Figure 6 and Figure 11As shown, the thermistor 111 is fixed in the thermistor mounting hole c, and the thermistor mounting hole c is filled and bonded with the biocompatible glue 113, which plays a role of protecting and fixing the thermistor 111. The thermistor 111 needs to be completely exposed at the mounting hole c and cannot be blocked by the outer wall of the lumen, so as not to affect the heat transfer effect. Among them, the type of the thermistor 111 is selected as a two-wire NTC thermistor. The thermistor 111 is used to measure the blood temperature in the ventricle, so as to indirectly measure the cardiac output based on the heat dilution principle.

[0040] The above describes the preferred embodiment of the present application and the technical principles used thereby, and for those skilled in the art, any equivalent transformation, simple replacement and the like based on the technical solutions of the present application without departing from the spirit and scope of the present application shall belong to the protection scope of the present application.

Claims

1. An intermittent occlusion balloon catheter system for treating heart failure, characterized in that: The system includes a five-lumen double-balloon catheter, which includes a lumen body, a first balloon placed in the pulmonary artery, and a second balloon placed in the superior vena cava, wherein the first balloon and the second balloon are both fixed to the surface of the lumen body; a round head is provided at the distal end of the lumen body, and the diameter of the round head is no greater than the outer diameter of the catheter; the proximal end is connected to the extension tube assembly through an injection molding head; the lumen body is provided with five lumens, which are respectively connected to the first balloon extension tube, the second balloon extension tube, the thermistor extension tube, the distal extension tube, and the proximal extension tube; the injection pump is driven by a stepper motor, and a controller adjusts the forward and backward motion cycle of the stepper motor, thereby controlling the injection pump to fill and discharge the second balloon.

2. The intermittent occlusion balloon catheter system for treating heart failure according to claim 1, wherein: The lumen body is provided with five lumens, which respectively lead to the distal outflow hole, the proximal outflow hole, the thermistor mounting hole, the second balloon liquid hole and the first balloon air hole arranged at different circumferential positions of the lumen body, and then communicate with the corresponding extension tube.

3. The intermittent occlusion balloon catheter system for treating heart failure according to claim 2, wherein: The outer diameter of the five-lumen double-balloon catheter ranges from 2.3 to 3 mm, and the cross-sectional shapes of the five lumens are circular, elliptical or crescent-shaped; the diameters of the proximal and distal lumens are equal and largest, and the diameter of the second balloon lumen is larger than that of the first balloon lumen.

4. The intermittent occlusion balloon catheter system for treating heart failure according to claim 1, wherein: The length of the lumen body ranges from 1100 to 1200 mm, and a black scale line is provided on the surface of the lumen body every 100 mm along the length direction.

5. The intermittent occlusion balloon catheter system for treating heart failure according to claim 2, wherein: The distal outflow hole is arranged at the round head, the first balloon air hole is 6-7 mm away from the distal outflow hole; the thermistor mounting hole is 30-40 mm away from the distal outflow hole; the proximal outflow hole is 290-300 mm away from the distal outflow hole; and the second balloon liquid hole is 340-350 mm away from the distal outflow hole.

6. The intermittent occlusion balloon catheter system for treating heart failure according to claim 5, wherein: The first balloon is fixed at the air hole of the first balloon and can cover the round head after expansion; the second balloon is fixed at the liquid hole of the second balloon, and the balloon is fixed by bonding.

7. The intermittent occlusion balloon catheter system for treating heart failure according to claim 6, wherein: The first balloon is made of latex or modified silicone material, and its maximum diameter after expansion is 12-13 mm; the second balloon is made of non-compliant material, and its diameter after expansion is 26-30 mm.

8. The intermittent occlusion balloon catheter system for treating heart failure according to claim 1, wherein: The lumen body is made of medical polymer material; the injection head is made of polyethylene material and is provided with a suture ring groove for fixing the position of the five-lumen double-balloon catheter in clinical practice.

9. The intermittent occlusion balloon catheter system for treating heart failure according to claim 1, wherein: The injection pump mainly includes a screw stepping motor, a clamp assembly, a slider, a mounting frame and a medical syringe, wherein the medical syringe has a measuring range of 10-20 mL.

10. The intermittent occlusion balloon catheter system for treating heart failure according to claim 1, wherein: The controller has the functions of adjusting the movement law of the slider module in the injection pump and measuring the temperature of the thermistor and blood pressure.

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