Balloon sheath and heart failure treatment instrument

Abstract

Provided in the present disclosure are a balloon sheath and a heart failure treatment instrument. The balloon sheath comprises: a main sheath, which is provided with a main sheath cavity, an auxiliary sheath cavity, a first pressurizing sheath cavity and a second pressurizing sheath cavity, wherein the main sheath cavity is used for guiding the passage of a diagnosis and treatment instrument therethrough, and the auxiliary sheath cavity is used for guiding the passage of the balloon catheter therethrough; a first balloon, which is connected to an outer wall of the main sheath in a sealed manner and is in communication with the first pressurizing sheath cavity and the second pressurizing sheath cavity; a main connecting seat, which is connected to a proximal end of the main sheath and comprises a first port in communication with the main sheath cavity, a second port in communication with the auxiliary sheath cavity, a first side opening in communication with the main sheath cavity, and a second side opening in communication with the first pressurizing sheath cavity and the second pressurizing sheath cavity; an auxiliary sheath, which is in communication with the second port; an auxiliary connecting seat, which is connected to a proximal end of the auxiliary sheath and comprises a third port in communication with the auxiliary sheath and a third side opening, wherein the third port is used for allowing the balloon catheter to enter; and a first side branch pipe in communication with the first side opening, a second side branch pipe in communication with the second side opening, and a third side branch pipe in communication with the third side opening.

Description

Balloon sheath and heart failure treatment device

[0001] Cross-references

[0002] This disclosure refers to Chinese Patent Application No. 202310770326.1, filed on June 27, 2023, entitled “Balloon Sheath and Heart Failure Treatment Device,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to the technical field of medical equipment, and in particular to a balloon sheath and a heart failure treatment device. Background Art

[0004] Heart failure refers to a series of symptoms caused by insufficient blood perfusion due to dysfunction of the heart and inability to completely drain blood from the heart. Heart failure is generally divided into acute heart failure and chronic heart failure.

[0005] Acute heart failure is the most common type of acute left ventricular failure, which refers to a clinical syndrome characterized by acute myocardial damage or increased cardiac load, resulting in a sudden drop in cardiac output, increased pulmonary circulation pressure, and increased peripheral circulation resistance, which in turn causes pulmonary circulation congestion and acute pulmonary congestion, pulmonary edema, and may be accompanied by insufficient perfusion of tissues and organs and cardiogenic shock.

[0006] Chronic heart failure is divided into right heart failure and left heart failure. In right heart failure, the right ventricle's ability to eject blood decreases, leaving more blood in the right heart, leading to increased right heart pressure and difficulty in blood flow. Because the blood flowing into the right heart is systemic, it causes systemic congestion. Because the lower limbs are located lower in the body, congestion is most severe in the lower limbs. When water enters the surrounding tissues from the blood vessels in the lower limbs, it causes lower limb edema. In left heart failure, because the blood flowing into the left heart is pulmonary, it causes increased left atrial pressure and pulmonary venous pressure, which in turn causes pulmonary congestion and pulmonary edema.

[0007] In related technologies, depending on the different conditions of acute heart failure, the initial treatment is oxygen inhalation, and diuretics and cardiotonic drugs are given intravenously; if the condition still does not improve, vasoactive drugs are used to dilate and constrict blood vessels; if the condition is serious, blood pressure continues to drop or even cardiogenic shock occurs, it is necessary to monitor hemodynamics and adopt emergency non-drug treatment methods.

[0008] Treatments available in the prior art have limitations. For example, some patients respond well to intravenous diuretics, while others do not. This is because when there is excess fluid in the body, most of the excess fluid is not actually contained within the blood vessels, but rather in the interstitial spaces surrounding cells, a tissue called the interstitium. To fully relieve congestion, excess fluid in the interstitial space must first be moved into the blood vessels. In healthy individuals, this function is achieved through the lymphatic system, which actively drains fluid into the large veins above the heart. However, in patients with acute heart failure, the pressure within the large veins can be very high, slowing or even preventing the flow of lymph fluid into the veins, thereby hindering the decongestion process. Studies have found that incomplete diuresis (i.e., fluid retention) is a strong predictor of hospital readmission and mortality. As many as half of patients with acute heart failure are not fully diureticized upon discharge, resulting in approximately 25% of patients being readmitted within one month and approximately half of patients being readmitted within six months.

[0009] How to improve the effect of heart failure treatment is a technical problem that needs to be solved urgently.

[0010] Summary of the Invention

[0011] The embodiments of the present disclosure provide a balloon sheath and a heart failure treatment device, which can be used to treat acute congestive heart failure and can achieve good prognosis.

[0012] According to one aspect of the present disclosure, a balloon sheath is provided, comprising: a main sheath, having a main lumen, a secondary lumen, a first inflation lumen and a second inflation lumen that are not connected to each other, the main lumen being used to guide the passage of diagnostic and treatment instruments, and the secondary lumen being used to guide the passage of a balloon catheter; a first balloon, sealedly connected to the outer wall of the main sheath and connected to the distal ends of the first inflation lumen and the second inflation lumen; a main connecting seat, connected to the proximal end of the main sheath and comprising a first port connected to the main lumen, a second port connected to the secondary lumen, a first side port connected to the main lumen, and a second side port connected to the first inflation lumen and the second inflation lumen, the first port being used for the insertion of diagnostic and treatment instruments; a secondary sheath, connected to the second port; a secondary connecting seat, connected to the proximal end of the secondary sheath and comprising a third port and a third side port connected to the secondary sheath, the third port being used for the insertion of a balloon catheter; and a first side branch connected to the first side port, a second side branch connected to the second side port for inputting inflation medium, and a third side branch connected to the third side port.

[0013] In some embodiments, the main lumen and the auxiliary lumen are respectively in the shape of circular holes, and the aperture of the main lumen is larger than that of the auxiliary lumen; the first inflation lumen and the second inflation lumen are located on both sides of the main lumen and the auxiliary lumen.

[0014] In some embodiments, the main sheath is provided with at least one through hole connecting the first and second inflation lumens with the first balloon, and the first balloon is a compliant tube-walled balloon that fits in contact with the outer wall of the main sheath in a contracted state.

[0015] In some embodiments, the material of the first balloon includes at least one of silicone, latex, polyurethane, and polyurethane.

[0016] In some embodiments, the main sheath includes a first tip portion adjacent to its distal end, the distal through-hole of the main lumen is exposed at the end surface of the first tip portion, and the distal through-hole of the secondary lumen is exposed at the side surface of the first tip portion.

[0017] In some embodiments, the proximal ends of the first side branch, the second side branch, and the third side branch are respectively provided with a Luer connector tee.

[0018] In some embodiments, the balloon sheath further includes: a main hemostatic valve disposed in the main connecting seat; and a secondary hemostatic valve disposed in the secondary connecting seat.

[0019] According to one aspect of the present disclosure, a heart failure treatment device is provided, comprising the balloon sheath according to the aforementioned aspect.

[0020] In some embodiments, the heart failure treatment device also includes: a balloon catheter nested and assembled with the secondary sheath and the main sheath, the balloon catheter including: a multi-lumen tube, having a guidewire insertion lumen, a pressurized medium delivery lumen and a contrast agent delivery lumen that are not connected to each other, and a contrast agent delivery hole exposed to the outer wall of the multi-lumen tube and connected to the distal end of the contrast agent delivery lumen; a single-lumen tube, connected to the distal end of the guidewire insertion lumen; a second balloon, sealedly connected to the outer wall of the multi-lumen tube and the outer wall of the single-lumen tube and connected to the distal end of the pressurized medium delivery lumen; and a connecting seat, connected to the proximal end of the multi-lumen tube and including a first connector connected to the guidewire insertion lumen, a second connector connected to the pressurized medium delivery lumen, and a third connector connected to the contrast agent delivery lumen, the first connector being used for guidewire insertion, the second connector being used for inputting pressurized medium, and the third connector being used for inputting contrast agent.

[0021] In some embodiments, the guidewire insertion lumen is in the shape of a circular hole and its central axis coincides with the central axis of the multi-lumen tube; the pressurized medium delivery lumen and the contrast agent delivery lumen are respectively in the shape of arc holes surrounding the guidewire insertion lumen.

[0022] In some embodiments, the second balloon is a non-compliant balloon, and the material of the second balloon includes at least one of polyamide, polyether block polyamide, and polyethylene.

[0023] In some embodiments, the contrast agent delivery hole is located on a side of the second balloon distal to the single lumen tube.

[0024] In some embodiments, the single lumen tube includes a second tip portion adjacent to its distal end.

[0025] In some embodiments, the balloon catheter further comprises a visualization element disposed on the outer wall of the single-lumen tube.

[0026] In some embodiments, the balloon catheter further comprises a reinforcing sleeve, which is sleeved over the connection between the multi-lumen tube and the connecting seat and seals the multi-lumen tube and the connecting seat.

[0027] According to one or more embodiments of the present disclosure, on the one hand, the first balloon of the balloon sheath and the second balloon of the balloon catheter passing through the balloon sheath can be used to intermittently block the vein, thereby reducing the venous blood backflow to the heart, reducing the preload of the heart, and reducing the stress on the ventricular wall; on the other hand, the first balloon of the balloon sheath and the second balloon of the balloon catheter passing through the balloon sheath can be synchronously inflated and depressurized according to the cardiac rhythm, thereby producing a dual hemodynamic effect, increasing diastolic pressure and coronary perfusion, reducing cardiac afterload and improving left ventricular ejection. During the treatment process or before and after treatment, the main lumen of the balloon sheath can also be passed through to diagnostic and treatment instruments for relevant testing and treatment. Therefore, the balloon sheath of the embodiment of the present disclosure can be used to treat acute congestive heart failure and can achieve good prognosis.

[0028] These and other aspects of the disclosure will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the embodiments of the present disclosure. Obviously, the drawings described below are only some embodiments of the present disclosure. Those skilled in the art can also derive other drawings based on the drawings without inventive effort. In the following description of exemplary embodiments in conjunction with the drawings, more details, features, and advantages of the present disclosure are disclosed. In the drawings:

[0030] FIG1 is a schematic structural diagram of a heart failure treatment device according to some embodiments of the present disclosure;

[0031] FIG2 is a schematic structural diagram of a balloon sheath tube according to some embodiments of the present disclosure; and

[0032] FIG3 is a schematic structural diagram of a balloon catheter according to some embodiments of the present disclosure.

[0033] Description of reference numerals:

[0034] 100-Balloon sheath; 300-Balloon catheter; 500-Heart failure treatment device; 10-Main sheath; 101-Main lumen; 102-Secondary lumen; 103-First pressure lumen; 104-Second pressure lumen; 11-First balloon; 12-Main connector; 121-First port; 122-Second port; 123-First side port; 124-Second side port; 13-Secondary sheath; 14-Secondary connector; 141-Third port; 142-Third side port; 15-First side branch; 16-Second side branch; 17-Third side branch; 18-Luer connector tee; 1 06-first tip portion; 191-main hemostatic valve; 192-secondary hemostatic valve; 30-multi-lumen tube; 301-guidewire insertion lumen; 302-pressurized medium delivery lumen; 303-contrast agent delivery lumen; 304-contrast agent delivery hole; 31-single-lumen tube; 32-second balloon; 33-connecting seat; 331-first connector; 332-second connector; 333-third connector; 311-second tip portion; 312-developing element; 34-reinforcement sleeve; 193-main dilator; 1931-single-lumen catheter; 1932-dilator seat; 194-secondary dilator. DETAILED DESCRIPTION

[0035] Hereinafter, only certain exemplary embodiments are briefly described. As will be appreciated by those skilled in the art, the described embodiments may be modified in various ways without departing from the spirit or scope of the present disclosure. Therefore, the drawings and description are to be considered as illustrative in nature and not restrictive.

[0036] Heart failure is currently the leading cause of death worldwide, with its incidence increasing annually. Heart failure is caused by a decrease in the ventricular pumping or filling capacity, resulting in an inability of the heart to pump enough blood to meet the body's metabolic needs. This leads to insufficient blood perfusion to organs and tissues, and congestion in the pulmonary or systemic circulation. Heart failure, a syndrome characterized by various heart diseases reaching a severe stage, is also commonly referred to as congestive heart failure.

[0037] Reducing ventricular wall stress by reducing cardiac preload is the cornerstone of treatment for acute congestive heart failure. The Frank-Starling mechanism (a compensatory mechanism in heart failure) suggests that preload is the primary determinant of cardiac output and further suggests that in patients with systolic heart failure who are volume overloaded, reducing volume overload may increase cardiac output, or at least not decrease it. Current research suggests that elevated cardiac filling pressures directly impact both short-term and long-term outcomes in patients with heart failure.

[0038] Current treatments for heart failure often involve reducing cardiac preload through diuresis and vasodilation. Specialized devices designed to reduce cardiac congestion include accelerated water separation, hemodialysis, and innovative approaches such as a pump within the descending aorta. However, due to concerns about decreased cardiac output and systemic blood pressure, few devices are currently designed specifically to reduce cardiac preload.

[0039] The embodiments of the present disclosure provide a balloon sheath and a heart failure treatment device, which can be used to treat acute congestive heart failure and can achieve good prognosis.

[0040] As shown in Figures 1 and 2, the balloon sheath 100 provided in some embodiments of the present disclosure is applied to a heart failure treatment device 500. The balloon sheath 100 includes a main sheath 10, a first balloon 11, a main connecting seat 12, a secondary sheath 13, a secondary connecting seat 14, and three side branches. The main sheath 10 has a main lumen 101, a secondary lumen 102, a first pressurized lumen 103, and a second pressurized lumen 104 that are not connected to each other, wherein the main lumen 101 is used to guide the diagnostic and treatment device (not shown in the figure) to pass through, and the secondary lumen 102 is used to guide the balloon catheter 300 to pass through. The first balloon 11 is sealed and connected to the outer wall of the main sheath 10 and is connected to the distal ends of the first pressurized lumen 103 and the second pressurized lumen 104. The main connecting seat 12 is connected to the proximal end of the main sheath 10 and includes a first port 121 communicating with the main lumen 101, a second port 122 communicating with the auxiliary lumen 102, a first side port 123 communicating with the main lumen 101, and a second side port 124 communicating with the first pressurized lumen 103 and the second pressurized lumen 104, wherein the first port 121 is used for inserting diagnostic and treatment instruments. The auxiliary sheath 13 is connected to the second port 122. The auxiliary connecting seat 14 is connected to the proximal end of the auxiliary sheath 13 and includes a third port 141 and a third side port 142 communicating with the auxiliary sheath 13, wherein the third port 141 is used for inserting the balloon catheter 300. The first side branch 15 is connected to the first side port 123, the second side branch 16 is used to input the pressurized medium and is connected to the second side port 124, and the third side branch 17 is connected to the third side port 142.

[0041] In the disclosed embodiments, using the balloon sheath tube 100 as an example, the end of the balloon sheath tube 100 or its components that is closer to the operator in the extension direction is defined as the "proximal end." Similarly, the end of the balloon sheath tube 100 or its components that is farther from the operator in the extension direction is defined as the "distal end." The definitions of the "proximal end" and "distal end" of the balloon catheter 300 or its components can be referred to in relation to the balloon sheath tube 100 and will not be repeated here. A "side opening" is defined as an opening provided on the side surface of a component, and a "port" is defined as an opening provided on the end surface of a component.

[0042] The balloon sheath 100 of the disclosed embodiment is used to provide a passage for the balloon catheter 300 and other diagnostic and treatment instruments and can block blood vessels through its balloon. The diagnostic and treatment instruments can be inserted into the main lumen 101 from the first port 121 of the main connecting seat 12, and the balloon catheter 300 can be inserted into the secondary lumen 102 from the third port 141 of the secondary connecting seat 14. The main lumen 101 can be filled with flushing fluid using the first side branch 15, the first and second pressurized lumens 103, 104 can be filled with pressurized medium using the second side branch 16, and the secondary lumen 102 can be filled with flushing fluid or blood can be extracted using the third side branch 17. In some embodiments, the proximal ends of the first side branch 15, the second side branch 16, and the third side branch 17 are respectively provided with a Luer connector tee 18, thereby allowing multiple compatible fluids to be managed using the same pipeline.

[0043] After the balloon sheath 100 is inserted into the human body, the balloon catheter 300 and / or diagnostic and treatment equipment can be inserted using the balloon sheath 100 and related guides as a guide, so that the first balloon 11 of the balloon sheath 100 and the second balloon 32 of the balloon catheter 300 can be used to block the blood vessels, and related diagnostic and treatment operations can be performed using the diagnostic and treatment equipment. In some embodiments of the present disclosure, the operation process of inserting the balloon sheath 100 and the balloon catheter 300 into the human body is as follows: use a puncture needle to perform puncture → insert a short guide wire into the puncture needle → pull out the puncture needle → insert the balloon sheath 100 guided by the short guide wire (the first port 121 of the balloon sheath 100 is pre-installed with a main dilator 193 (as shown in Figure 2, the single-lumen catheter 1931 of the main dilator 193 extends out of the distal end of the balloon sheath 100), and the short guide wire passes through the main lumen 101 of the balloon sheath 100) → pull out the short guide wire and the main dilator 193 → insert the long guide wire into the secondary lumen 102 of the balloon sheath 100 through the secondary dilator 194 pre-installed on the third port 141 of the secondary connecting seat 14 → pull out the secondary dilator 194 → insert the balloon catheter 300 guided by the long guide wire → pull out the long guide wire. Among them, the short guide wire, the long guide wire, the main dilator 193 and the auxiliary dilator 194 serve as intermediate auxiliary instruments when inserting the balloon sheath 100 and the balloon catheter 300.

[0044] According to the design of the embodiment of the present disclosure, on the one hand, the first balloon 11 of the balloon sheath tube 100 and the second balloon 32 of the balloon catheter 300 passing through the balloon sheath tube 100 can be used to intermittently block the vein, thereby reducing the venous blood backflow to the heart, reducing the preload of the heart, and reducing the stress on the ventricular wall; on the other hand, the first balloon 11 of the balloon sheath tube 100 and the second balloon 32 of the balloon catheter 300 passing through the balloon sheath tube 100 can be synchronously inflated and depressurized according to the cardiac rhythm, thereby producing a dual hemodynamic effect, increasing diastolic pressure and coronary perfusion, reducing cardiac afterload and improving left ventricular ejection. During the treatment process or before and after treatment, the main lumen 101 of the balloon sheath tube 100 can also be passed through diagnostic and treatment instruments for relevant testing and treatment. Therefore, the balloon sheath tube 100 of the embodiment of the present disclosure can be used to treat acute congestive heart failure and can achieve good prognosis.

[0045] The cross-sectional shape and arrangement of each lumen of the main sheath 10 are not limited. As shown in Figure 2, in some embodiments of the present disclosure, the main lumen 101 and the secondary lumen 102 are respectively in the shape of circular holes, wherein the aperture R1 of the main lumen 101 is larger than the aperture R2 of the secondary lumen 102, and the first charging lumen 103 and the second charging lumen 104 are located on both sides of the main lumen 101 and the secondary lumen 102. Since the main lumen 101 needs to be passed through the diagnostic and treatment equipment, in order to enable it to be passed smoothly, its aperture is designed to be relatively large. The aperture of the secondary lumen 102 can be designed accordingly based on the outer diameter of the second balloon 32 of the balloon catheter 300 in the contracted state, so that the balloon catheter 300 can pass smoothly. The main sheath 10 can be formed by an extrusion process, and the cavity spaces on both sides of the main lumen 101 and the secondary lumen 102 serve as the first charging lumen 103 and the second charging lumen 104.

[0046] As shown in FIG2 , in some embodiments, the main sheath 10 includes a first tip portion 106 adjacent to its distal end, wherein the distal exit hole of the main lumen 101 is exposed on the end surface of the first tip portion 106, and the distal exit hole of the secondary lumen 102 is exposed on the side surface of the first tip portion 106. In other words, diagnostic and treatment instruments can be passed through the end surface of the first tip portion 106 of the main sheath 10, and the balloon catheter 300 can be passed through the side surface of the first tip portion 106 of the main sheath 10. The design of the first tip portion 106 of the main sheath 10 can reduce the resistance of the main sheath 10 in the blood vessel, making entry smoother.

[0047] In some embodiments of the present disclosure, the material of the main sheath 10 and the auxiliary sheath 13 may include at least one of polyamide, polyether block polyamide, acrylonitrile-butadiene-styrene terpolymer, and polyethylene terephthalate.

[0048] In some embodiments of the present disclosure, the main sheath 10 is provided with at least one through hole (not shown in the figure, for example, a hole can be directly opened in the outer wall of the main sheath 10 opposite the first balloon 11) that connects the first and second inflation lumens 103, 104 to the first balloon 11. The first balloon 11 is a compliant tubular-walled balloon that conforms to the outer wall of the main sheath 10 in a deflated state. The compliant tubular-walled balloon is tubular-walled in a deflated state, and its proximal and distal inner walls can be sealed and bonded to the outer wall of the main sheath 10, thereby achieving balloon sealing.

[0049] First balloon 11 is constructed from a compliant material, such as at least one of silicone, latex, polyurethane, and polyurethane. This allows for a larger expanded diameter at relatively low pressures, and its expanded diameter significantly increases with increasing pressure, effectively anchoring the balloon after expansion and providing reliable support within the blood vessel. Furthermore, first balloon 11 utilizes a tubular wall design that conforms to the outer wall of main sheath 10 in its deflated state, resulting in a smaller outer diameter to minimize resistance within the blood vessel and mitigate harm to the human body.

[0050] In the disclosed embodiment, the material of the primary connector 12 and the secondary connector 14 can include at least one of acrylonitrile-butadiene-styrene terpolymer, polyamide, polycarbonate, and polyoxymethylene. The primary connector 12 and the secondary connector 14 provide access for other instruments or therapeutic media. Their material is harder than that of the primary sheath 10 and the secondary sheath 13, facilitating assembly and instrument operation. Furthermore, a hemostatic valve can be installed within them.

[0051] As shown in FIG2 , in some embodiments, the balloon sheath 100 further includes a primary hemostatic valve 191 (illustrated only) disposed within the primary connector 12 and a secondary hemostatic valve 192 (illustrated only) disposed within the secondary connector 14. The primary and secondary hemostatic valves 191 and 192 utilize their own elastic forces to create a seal, preventing blood from flowing out and achieving a hemostatic effect. The primary and secondary hemostatic valves 191 and 192 can be constructed, for example, from at least one of silicone, latex, polyurethane, and polyurethane.

[0052] In the embodiment of the present disclosure, the first side branch 15, the second side branch 16 and the third side branch 17 are single-lumen tubes that are flexible and can withstand a certain pressure. They can provide pathways for various treatment media or flushing media, and can also collect body fluids during treatment. Their materials can, for example, include at least one of polyethylene, polyvinyl chloride, and polyether block polyamide.

[0053] In some embodiments of the present disclosure, the main dilator 193 and the auxiliary dilator 194 serve as intermediate auxiliary instruments when inserting the balloon sheath 100 and the balloon catheter 300. As shown in Figure 2, taking the main dilator 193 as an example, its main structure includes a single-lumen catheter 1931 and a dilator seat 1932, which is used to provide a channel for the guide wire to enter the main sheath 10. The head end of the single-lumen catheter 1931 is provided with a gradient section, which facilitates the assembly of the main dilator 193 with the main sheath 10 through the main hemostatic valve 191. The material of the single-lumen catheter 1931 may include at least one of polyethylene, polyvinyl chloride, and polyether block polyamide, and metal oxides such as barium sulfate may be added to have developability. The dilator seat 1932 may include a Luer connector (not shown in the figure), and its material may be consistent with the material of the single-lumen catheter 1931.

[0054] 1 , an embodiment of the present disclosure further provides a heart failure treatment device 500 , comprising the balloon sheath 100 of any of the aforementioned embodiments.

[0055] The heart failure treatment device 500 may include relevant diagnostic and treatment instruments, a balloon catheter 300, and external equipment (such as a pump). The heart failure treatment device 500 can be used not only for venous occlusion treatment but also for intra-aortic counterpulsation treatment, achieving good prognostic results in the treatment of acute congestive heart failure.

[0056] In some embodiments of the present disclosure, the heart failure treatment device 500 further includes a balloon catheter 300 nested with the secondary sheath 13 and the main sheath 10. The specific structure of the balloon catheter 300 is not limited and can be specifically designed according to actual needs.

[0057] As shown in FIG3 , in some embodiments, the main structure of the balloon catheter 300 includes a multi-lumen tube 30, a single-lumen tube 31, a second balloon 32, and a connector 33. The multi-lumen tube 30 has a guidewire insertion lumen 301, a pressurized medium delivery lumen 302, and a contrast agent delivery lumen 303 that are not connected to each other, and a contrast agent delivery hole 304 exposed on the outer wall of the multi-lumen tube 30 and connected to the distal end of the contrast agent delivery lumen 303. The single-lumen tube 31 is connected to the distal end of the guidewire insertion lumen 301. The second balloon 32 is sealed to the outer wall of the multi-lumen tube 30 and the outer wall of the single-lumen tube 31 and is connected to the distal end of the pressurized medium delivery lumen 302. The connecting seat 33 is connected to the proximal end of the multi-lumen tube 30 and includes a first connector 331 connected to the guide wire insertion lumen 301, a second connector 332 connected to the pressurized medium delivery lumen 302, and a third connector 333 connected to the contrast agent delivery lumen 303, wherein the first connector 331 is used for guide wire insertion, the second connector 332 is used for inputting pressurized medium, and the third connector 333 is used for inputting contrast agent.

[0058] After the balloon catheter 300 is placed into the human body and positioned using the balloon sheath 100 provided in the aforementioned embodiment of the present disclosure, the first balloon 11 and the second balloon 32 can be alternately and intermittently filled using an external pressurized medium input device, thereby achieving alternating and intermittent occlusion of the inferior vena cava and the subclavian vein, thereby reducing the reflux of venous blood to the heart, or the first balloon 11 and the second balloon 32 can be synchronously pressurized and depressurized according to the cardiac rhythm, thereby increasing diastolic pressure and coronary perfusion, reducing cardiac afterload and improving left ventricular ejection. In addition, an external contrast fluid input device can be used to inject contrast fluid into the blood vessel through the contrast agent delivery lumen 303. In some embodiments, the contrast agent delivery hole 304 can be designed on the side of the second balloon 32 away from the single-lumen tube 31.

[0059] The specific internal structure of the multi-lumen tube 30 is not limited. As shown in Figure 3, in some embodiments, the guidewire insertion lumen 301 is circular, with its central axis coinciding with the central axis of the multi-lumen tube 30. The pressurized medium delivery lumen 302 and the contrast agent delivery lumen 303 are each arc-shaped and surround the guidewire insertion lumen 301. The material of the multi-lumen tube 30 can include at least one of polyamide and polyether block polyamide.

[0060] As shown in FIG3 , in some embodiments, the single-lumen tube 31 includes a second tip portion 311 adjacent to its distal end, which helps reduce the resistance of the balloon catheter 300 in the blood vessel, making entry smoother. The single-lumen tube 31 can be made of a relatively soft material, such as at least one of polyurethane, polyurethane, polyether block polyamide, and silicone.

[0061] A developing element 312 can be disposed on the outer wall of the single-lumen tube 31 and can be designed within the second balloon 32. During surgery, the developing element 312 can be detected using external imaging equipment (such as X-ray detection equipment) to accurately determine its position and achieve precise positioning. The developing element 312 can be made of one or more materials selected from gold, platinum, iridium, tantalum, tungsten, and the like.

[0062] In some embodiments, second balloon 32 is a non-compliant balloon, and its material may include at least one of polyamide, polyether block polyamide, and polyethylene. Once inflated to a certain diameter, the non-compliant balloon maintains this diameter regardless of external pressure changes, allowing for precise occlusion of a specific blood vessel without damaging the vessel due to overinflation.

[0063] As shown in FIG3 , in some embodiments, the balloon catheter 300 further includes a reinforcing sleeve 34 that is disposed at the connection between the multilumen tube 30 and the connector 33 and seals the multilumen tube 30 to the connector 33. The reinforcing sleeve 34 is used to securely seal the connection between the multilumen tube 30 and the connector 33 and prevent excessive bending at the connection. The reinforcing sleeve 34 can be made of at least one of polyamide, acrylonitrile-butadiene-styrene terpolymer, polyolefin, and polyether block polyamide, and can also contain metal oxides such as barium sulfate.

[0064] The treatment implementation cases of the heart failure treatment device 500 according to some embodiments of the present disclosure are as follows:

[0065] First, a channel is established in the femoral vein through the puncture kit and a guide wire is inserted; then, the balloon sheath 100 is introduced into the human body from the femoral vein along the guide wire (the guide wire penetrates the main lumen 101 of the balloon sheath 100), and the first balloon 11 is positioned in the inferior vena cava under angiography, and its position is below the renal vein, and the balloon sheath 100 is fixed; then, a guide wire is inserted into the secondary lumen 102 of the balloon sheath 100, and the guide wire is passed along the inferior vena cava upward through the heart, superior vena cava, brachiocephalic vein to the subclavian vein; then, the balloon catheter 300 is passed along the guide wire through the secondary lumen 102 to the designated position. During this process, contrast agent is delivered to the blood vessel through the contrast agent delivery hole 304 of the balloon catheter 300 to monitor that the second balloon 32 accurately reaches the occlusion position.

[0066] Afterwards, the balloon sheath 100 and the balloon catheter 300 are connected to the pressure pumps respectively, and the cyclic treatment process including the following four steps is started:

[0067] Step 1: The first balloon 11 is pressurized in 4-5 seconds and the pressure is maintained for 15 seconds. At this time, the second balloon 32 remains unpressurized.

[0068] Step 2: The first balloon 11 is depressurized within 4-5 seconds, allowing blood to circulate for 1 minute;

[0069] Step 3: The second balloon 32 is fully inflated in 4-5 seconds, and the pressure is maintained for 15 seconds. During this time, the first balloon 11 remains uninflated.

[0070] Step 4: The second balloon 32 is depressurized in 4-5 seconds, allowing blood to circulate for 1 minute. At this time, the first balloon 11 remains in a non-pressurized state.

[0071] Repeat the above treatment process several times until the treatment is completed. Through the above treatment process, the return of venous blood to the heart can be slowed down and the precardiac load can be reduced.

[0072] During or before and after treatment, diagnostic and treatment instruments may be passed through the main lumen 101 for relevant testing and treatment. The diagnostic and treatment instruments may be, for example, floating catheters, ablation catheters, and the like.

[0073] It can be seen that for the treatment of venous occlusion, the vein can be blocked by intermittent inflation and decompression of two balloons, thereby reducing the return of blood from the vein to the heart and alleviating the precardiac load. The main cavity 101 can provide a channel for other diagnostic and treatment equipment.

[0074] The treatment implementation cases of the heart failure treatment device 500 according to other embodiments of the present disclosure are as follows:

[0075] First, a channel is established in the femoral artery through the puncture kit and a guidewire is inserted; then, the balloon sheath 100 is introduced into the human body from the femoral artery along the guidewire (the guidewire penetrates the main lumen 101 of the balloon sheath 100), and the first balloon 11 is positioned below the aortic arch under angiography, and its position is located in the thoracic aorta, and the balloon sheath 100 is fixed; then, a guidewire is inserted into the secondary lumen 102 of the balloon sheath 100, and the guidewire is passed along the femoral artery into one of the left subclavian artery, common carotid artery, and brachiocephalic artery (specific details depend on clinical evaluation); then, the balloon catheter 300 is passed along the guidewire through the secondary lumen 102 to the designated position. During this process, contrast agent is delivered into the blood vessel through the contrast agent delivery hole 304 provided in the balloon catheter 300 to monitor whether the second balloon 32 accurately reaches the occlusion position.

[0076] Afterwards, the balloon sheath 100 and the balloon catheter 300 are connected to the pressure pumps respectively, and the following treatment process begins:

[0077] During diastole, the first and second balloons 11 and 32 are inflated and sealed, while during systole, the pressure is released. This creates a dual hemodynamic effect: inflating the two balloons during diastole allows blood to flow forward, thereby increasing diastolic pressure and coronary perfusion; deflating the two balloons during systole reduces systolic pressure (cardiac afterload), thereby improving left ventricular ejection. The pressure pump can inflate and release the first and second balloons 11 and 32 once per cardiac cycle (in a 1:1 ratio), once every two cardiac cycles (in a 1:2 ratio), or once every three cardiac cycles (in a 1:3 ratio).

[0078] During the treatment process or before and after the treatment, the main lumen 101 can be used to pass diagnostic and treatment instruments for relevant testing and treatment. The diagnostic and treatment instruments may be, for example, a coronary balloon, a coronary stent, etc.

[0079] It can be seen that for the treatment of intra-aortic counterpulsation, the two balloons can be inflated and deflated simultaneously according to the heart rhythm, thereby producing a dual hemodynamic effect, increasing diastolic pressure and coronary perfusion, reducing cardiac afterload and improving left ventricular ejection; in addition, the main lumen 101 can provide a channel for other diagnostic and treatment equipment.

[0080] It should be understood that in this specification, the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships or dimensions based on the orientations or positional relationships or dimensions shown in the accompanying drawings, and these terms are used only for the convenience of description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the scope of protection of the present disclosure.

[0081] Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first," "second," or "third" may explicitly or implicitly include one or more of the features. Throughout the present disclosure, "plurality" means two or more, unless otherwise specifically defined.

[0082] In this disclosure, unless otherwise expressly specified or limited, terms such as "mounted," "connected," "connect," and "fixed" should be understood broadly. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections, electrical connections, or communication; direct connections or indirect connections through an intermediate medium; and internal connections between two components or interactions between two components. Those skilled in the art will understand the specific meanings of these terms in this disclosure based on specific circumstances.

[0083] In the present disclosure, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature includes the first feature being directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0084] This specification provides many different embodiments or examples that can be used to implement the present disclosure. It should be understood that these different embodiments or examples are purely exemplary and are not intended to limit the scope of protection of the present disclosure in any way. Those skilled in the art can conceive of various changes or replacements based on the disclosure of the specification of the present disclosure, all of which should be included within the scope of protection of the present disclosure. Therefore, the scope of protection of the present disclosure should be based on the scope of protection defined by the appended claims.

Claims

1. A balloon sheath, comprising: The main sheath has a main lumen, a secondary lumen, a first pressurized lumen and a second pressurized lumen which are not connected to each other, the main lumen is used to guide the diagnosis and treatment instrument to pass through, and the secondary lumen is used to guide the balloon catheter to pass through; A first balloon is sealed and connected to the outer wall of the main sheath and is in communication with the distal ends of the first and second inflation lumens; a main connecting seat connected to the proximal end of the main sheath and comprising a first port communicating with the main lumen, a second port communicating with the secondary lumen, a first side port communicating with the main lumen, and a second side port communicating with the first and second pressurized lumen, wherein the first port is used for the diagnostic and treatment instrument to penetrate; A secondary sheath tube, connected to the second port; A secondary connection seat, connected to the proximal end of the secondary sheath tube and comprising a third port and a third side port communicated with the secondary sheath tube, wherein the third port is used for the balloon catheter to penetrate; as well as A first side branch pipe communicated with the first side port, a second side branch pipe communicated with the second side port for inputting a pressurized medium, and a third side branch pipe communicated with the third side port.

2. The balloon sheath according to claim 1, wherein: The main lumen and the auxiliary lumen are respectively in the shape of circular holes, and the aperture of the main lumen is larger than the aperture of the auxiliary lumen; The first pressure-inflating lumen and the second pressure-inflating lumen are located on both sides of the main lumen and the secondary lumen.

3. The balloon sheath according to claim 1, wherein: The main sheath is provided with at least one through hole connecting the first and second inflation lumens with the first balloon. The first balloon is a compliant wall-shaped balloon that fits with the outer wall of the main sheath in a contracted state.

4. The balloon sheath according to any one of claims 1 to 3, wherein: The material of the first balloon includes at least one of silicone, latex, polyurethane, and polyurethane.

5. The balloon sheath according to any one of claims 1 to 4, wherein: The main sheath tube comprises a first tip portion adjacent to its distal end, the distal through hole of the main lumen is exposed at the end surface of the first tip portion, and the distal through hole of the secondary lumen is exposed at the side surface of the first tip portion.

6. The balloon sheath according to any one of claims 1 to 5, wherein: The proximal ends of the first side branch tube, the second side branch tube and the third side branch tube are respectively provided with a Luer connector tee.

7. The balloon sheath according to any one of claims 1 to 5, further comprising: A main hemostatic valve disposed in the main connecting seat; as well as A secondary hemostatic valve is arranged in the secondary connecting seat.

8. A heart failure treatment device, comprising: The balloon sheath according to any one of claims 1 to 7.

9. The heart failure treatment device according to claim 8, further comprising: A balloon catheter nested and assembled with the auxiliary sheath tube and the main sheath tube, the balloon catheter comprising: A multi-lumen tube having a guide wire insertion lumen, a pressurized medium delivery lumen and a contrast agent delivery lumen which are not communicated with each other, and a contrast agent delivery hole which is exposed to the outer wall of the multi-lumen tube and communicated with the distal end of the contrast agent delivery lumen; a single lumen tube, connected to the distal end of the guide wire penetrating into the lumen; A second balloon is sealedly connected to the outer wall of the multi-lumen tube and the outer wall of the single-lumen tube and is in communication with the distal end of the pressurized medium delivery lumen; and A connecting seat is connected to the proximal end of the multi-lumen tube and includes a first connector connected to the guide wire insertion lumen, a second connector connected to the pressurized medium delivery lumen, and a third connector connected to the contrast agent delivery lumen, wherein the first connector is used for guide wire insertion, the second connector is used for inputting pressurized medium, and the third connector is used for inputting contrast agent.

10. The heart failure treatment device according to claim 9, wherein: The guide wire is inserted into the tube cavity in the shape of a circular hole and its central axis coincides with the central axis of the multi-lumen tube; The pressurized medium delivery lumen and the contrast agent delivery lumen are respectively in the form of arc-shaped holes surrounding the guide wire penetration lumen.

11. The heart failure treatment device according to claim 9, wherein: The second balloon is a non-compliant balloon, and the material of the second balloon includes at least one of polyamide, polyether block polyamide, and polyethylene.

12. The heart failure treatment device according to claim 9, wherein: The contrast agent delivery hole is located on a side of the second balloon away from the single-lumen tube.

13. The heart failure treatment device according to claim 9, wherein: The single lumen tube includes a second tip portion adjacent a distal end thereof.

14. The heart failure treatment device according to claim 9, wherein: The balloon catheter also includes: A developing element is arranged on the outer wall of the single lumen tube.

15. The heart failure treatment device according to any one of claims 9 to 14, wherein: The balloon catheter also includes: The reinforcing sleeve is sleeved at the connection between the multi-cavity tube and the connecting seat and seals the multi-cavity tube and the connecting seat.

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