Catheter instrument and heart failure treatment instrument

Abstract

Provided in the present disclosure are a catheter instrument and a heart failure treatment instrument. The catheter instrument comprises: a catheter body, having an instrument passing lumen, a balloon catheter passing lumen, a balloon pressurizing lumen and a pressure monitoring lumen, which are not in communication with one another; a balloon, which is connected to an outer wall of the catheter body in a sealing manner and is in communication with a distal end of the balloon pressurizing lumen; a connecting base, which is connected to a proximal end of the catheter body and comprises an end opening in communication with the instrument passing lumen, a first side opening in communication with the balloon catheter passing lumen, a second side opening in communication with the balloon pressurizing lumen and a third side opening in communication with the pressure monitoring lumen, wherein the end opening is configured to allow a medical instrument to pass therethrough, and the first side opening is configured to allow a balloon catheter to pass therethrough; a first side branch tube, which is in communication with the second side opening and is configured to input a balloon pressurizing medium; and a second side branch tube, which is in communication with the third side opening and is configured to input a pressure monitoring medium.

Description

Catheter devices and heart failure treatment devices

[0001] Cross-references

[0002] This disclosure refers to Chinese patent application No. 202310773544.0, filed on June 27, 2023, entitled “Catheter Device 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 catheter device 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 catheter device 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 catheter device is provided, comprising a catheter body having an instrument through lumen, a balloon catheter through lumen, a balloon inflation lumen and a pressure monitoring lumen that are not connected to each other; a balloon, sealedly connected to the outer wall of the catheter body and connected to the distal end of the balloon inflation lumen; a connecting seat, connected to the proximal end of the catheter body and comprising a port connected to the instrument through lumen, a first side port connected to the balloon catheter through lumen, a second side port connected to the balloon inflation lumen, and a third side port connected to the pressure monitoring lumen, wherein the port is used for insertion of diagnostic and treatment instruments, and the first side port is used for insertion of the balloon catheter; a first side branch tube connected to the second side port for inputting a balloon inflation medium; and a second side branch tube connected to the third side port for inputting a pressure monitoring medium.

[0013] In some embodiments, the catheter body is provided with at least one through hole connecting the balloon inflation lumen with the balloon, and the balloon is a compliant tube-walled balloon that fits in contact with the outer wall of the catheter body in a deflated state.

[0014] In some embodiments, the material of the balloon includes at least one of silicone, latex, polyurethane, and polyurethane.

[0015] In some embodiments, the instrument passage lumen, the balloon catheter passage lumen, the balloon inflation lumen and the pressure monitoring lumen are respectively in the shape of circular holes, wherein the center of the cross section of the instrument passage lumen, the center of the cross section of the catheter body, and the center of the cross section of the balloon catheter passage lumen are arranged in sequence along a first straight line direction; the center of the cross section of the balloon inflation lumen and the center of the cross section of the pressure monitoring lumen are arranged in sequence along a second straight line direction orthogonal to the first straight line direction.

[0016] In some embodiments, the aperture R1 of the lumen through which the instrument passes, the aperture R2 of the lumen through which the balloon catheter passes, the aperture R3 of the balloon inflation lumen, and the aperture R4 of the pressure monitoring lumen satisfy: R1>R2>R3=R4.

[0017] In some embodiments, the catheter body includes a main body portion and a tip portion connected to the distal end of the main body portion, wherein the instrument passes through the distal end of the lumen and the pressure monitoring lumen to the side of the tip portion, and the balloon catheter passes through the distal end of the lumen to the end face of the tip portion.

[0018] In some embodiments, the catheter device further comprises: a first visualization element disposed on an outer wall of the main body portion; and / or a second visualization element disposed on a side surface of the tip portion.

[0019] In some embodiments, the catheter device further includes: a first gland disposed at the port, and a first hemostatic valve disposed in the port and fixed by the first gland; and a second gland disposed at the first side port, and a second hemostatic valve disposed in the first side port and fixed by the second gland.

[0020] In some embodiments, the first hemostatic valve is a radial compression hemostatic valve, and the second hemostatic valve is a cross-cut hemostatic valve.

[0021] In some embodiments, the proximal ends of the first side branch and the second side branch are respectively provided with a Luer connector tee.

[0022] In some embodiments, the diagnostic and therapeutic device includes an inspection catheter, a floating catheter, or an ablation catheter.

[0023] According to one aspect of the present disclosure, a heart failure treatment device is provided, comprising the catheter device of the aforementioned aspect.

[0024] According to one or more embodiments of the present disclosure, the balloon of a catheter device and the balloon of a balloon catheter inserted through the catheter device can be used to intermittently block veins, thereby reducing venous blood backflow to the heart, lowering cardiac preload, and reducing ventricular wall stress. During treatment, or before and after treatment, diagnostic and treatment instruments can be inserted through the lumen of the device for relevant testing and treatment, and intravascular pressure can be monitored through the pressure monitoring lumen. The catheter device is used to treat acute congestive heart failure and can achieve good prognostic results.

[0025] 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

[0026] In order 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. For those skilled in the art, other drawings can be obtained based on the drawings without inventive work. 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:

[0027] FIG1 is a schematic diagram of the front structure of a catheter device according to some embodiments of the present disclosure; and

[0028] FIG2 is a schematic diagram of the three-dimensional structure of a catheter device according to some embodiments of the present disclosure.

[0029] Explanation of the reference numerals: 100-catheter instrument; 10-catheter body; 101-instrument passing through the lumen; 102-balloon catheter passing through the lumen; 103-balloon inflation lumen; 104-pressure monitoring lumen; 11-balloon; 12-connecting seat; 121-port; 122-first side port; 123-second side port; 124-third side port; 13-first side branch; 14-second side branch; 105-through hole; 106-main body; 107-tip portion; 15-first developing element; 16-second developing element; 17-first pressure cap; 18-second pressure cap; 19-first hemostatic valve; 20-second hemostatic valve; 21-Luer connector tee. DETAILED DESCRIPTION

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] The embodiments of the present disclosure provide a catheter device and a heart failure treatment device, which can be used to treat acute congestive heart failure and can achieve good prognosis.

[0035] The catheter device provided in some embodiments of the present disclosure is used as a heart failure treatment device. As shown in Figures 1 and 2, the catheter device 100 includes a catheter body 10, a balloon 11, a connector 12, a first side branch 13, and a second side branch 14. The catheter body 10 has a device passage lumen 101, a balloon catheter passage lumen 102, a balloon inflation lumen 103, and a pressure monitoring lumen 104, which are not interconnected. The balloon 11 is sealed to the outer wall of the catheter body 10 and communicates with the distal end of the balloon inflation lumen 103. The connector 12 is connected to the proximal end of the catheter body 10 and includes a port 121 that communicates with the instrument through lumen 101, a first side port 122 that communicates with the balloon catheter through lumen 102, a second side port 123 that communicates with the balloon inflation lumen 103, and a third side port 124 that communicates with the pressure monitoring lumen 104. Port 121 is used to insert a diagnostic instrument (not shown), and first side port 122 is used to insert a balloon catheter (not shown). The first side branch 13 is connected to the second side port 123 and is used to input a balloon inflation medium. The second side branch 14 is connected to the third side port 124 and is used to input a pressure monitoring medium.

[0036] In the disclosed embodiments, the end of the catheter device 100 or a component thereof that is closer to the operator in the direction of extension is defined as the "proximal end." Similarly, the end of the catheter device 100 or a component thereof that is farther from the operator in the direction of extension is defined as the "distal end." The definitions of the "proximal end" and "distal end" of balloon catheters or other devices are as described above and will not be repeated here. A "side port" is defined as an opening provided on the side surface of such a component, and a "port 121" is defined as an opening provided on the end surface of such a component.

[0037] The catheter device 100 of the disclosed embodiment is used to provide a pathway for a balloon catheter and other diagnostic and treatment instruments. It can occlude a blood vessel by inflating the balloon 11 with the aid of an external pressure pump, and can also monitor intravascular pressure during surgery using an external pressure sensor and a pressure monitoring lumen 104. A diagnostic and treatment instrument can be inserted into the instrument passage lumen 101 from the port 121 of the connector 12, and a balloon catheter can be inserted into the balloon catheter passage lumen 102 from the first side port 122 of the connector 12. With the aid of an external device, a pressurized medium can be injected into the balloon inflation lumen 103 using the first side branch 13, and a pressure monitoring medium can be injected into the pressure monitoring lumen 104 using the second side branch 14. In some embodiments, the proximal ends of the first and second side branches 13, 14 are each provided with a Luer connector tee 21, thereby allowing multiple compatible fluids to be managed using the same pipeline.

[0038] In some embodiments of the present disclosure, the diagnostic and treatment instrument may be an examination catheter, a floating catheter, or an ablation catheter, and the pressure monitoring medium may be, for example, heparin saline, etc. The present disclosure does not make specific limitations on this and may be selected according to the actual treatment plan.

[0039] After the catheter device 100 is implanted in the human body, a balloon catheter and / or diagnostic and treatment device can be implanted using the catheter device 100 and the related guide as a guide, so that the balloon 11 of the catheter device 100 and the balloon of the balloon catheter can be used to block the blood vessel, and the diagnostic and treatment device can be used to perform relevant diagnostic and treatment operations, and the intravascular pressure can be monitored through the pressure monitoring lumen 104 (which leads to the distal end of the catheter device 100 and leads to the blood vessel). In some embodiments of the present disclosure, the operation process of implanting the catheter device 100 and the balloon catheter in the human body is as follows: puncture with a puncture needle → insert a short guide wire into the puncture needle → pull out the puncture needle → insert the catheter device 100 using the short guide wire as a guide → pull out the short guide wire → insert the long guide wire into the balloon catheter of the catheter device 100 through the lumen 102 → insert the balloon catheter using the long guide wire as a guide → pull out the long guide wire. Among them, the short guide wire and the long guide wire serve as intermediate auxiliary devices when implanting the catheter device 100 and the balloon catheter.

[0040] According to the design of the disclosed embodiment, the balloon 11 of the catheter device 100 and the balloon of the balloon catheter passing through the catheter device 100 can be used to intermittently block the vein, thereby reducing venous blood backflow to the heart, lowering cardiac preload, and reducing ventricular wall stress. During treatment or before and after treatment, diagnostic and therapeutic instruments can be inserted through the device's lumen 101 for relevant testing and treatment, and intravascular pressure can be monitored through the pressure monitoring lumen 104. The catheter device 100 of the disclosed embodiment can be used to treat acute congestive heart failure and can achieve good prognostic results.

[0041] The cross-sectional shape and arrangement of the lumens of the catheter body 10 are not limited. As shown in FIG1 , in some embodiments of the present disclosure, the instrument passage lumen 101, the balloon catheter passage lumen 102, the balloon inflation lumen 103, and the pressure monitoring lumen 104 are each in the shape of a circular hole, wherein the center O1 of the cross section of the instrument passage lumen 101, the center O2 of the cross section of the catheter body 10, and the center O3 of the cross section of the balloon catheter passage lumen 102 are sequentially arranged along a first linear direction L1, and the center O4 of the cross section of the balloon inflation lumen 103 and the center O5 of the cross section of the pressure monitoring lumen 104 are sequentially arranged along a second linear direction L2 that is orthogonal to the first linear direction L1.

[0042] Since the instrument needs to be passed through the lumen 101 for diagnosis and treatment, its aperture is designed to be relatively large to facilitate smooth passage. The aperture of the balloon catheter through the lumen 102 can be designed accordingly based on the outer diameter of the balloon of the balloon catheter in the deflated state to allow the balloon catheter to pass smoothly. The balloon inflation lumen 103 and the pressure monitoring lumen 104 can be located on both sides of the instrument through lumen 101 and the balloon catheter through lumen 102. In some embodiments, the aperture R1 of the instrument through the lumen 101, the aperture R2 of the balloon catheter through the lumen 102, the aperture R3 of the balloon inflation lumen 103, and the aperture R4 of the pressure monitoring lumen 104 satisfy: R1>R2>R3=R4.

[0043] As shown in Figure 1, in some embodiments of the present disclosure, the catheter body 10 is provided with at least one through hole 105 connecting the balloon inflation lumen 103 with the balloon 11 (for example, a hole can be directly opened on the outer wall of the catheter body 10 to form the at least one through hole 105), and the balloon 11 is a compliant tubular wall balloon that fits with the outer wall of the catheter body 10 in a contracted state.

[0044] The proximal inner wall and the distal inner wall of the compliant tubular-walled balloon can be sealed and bonded to the outer wall of the catheter body 10 , thereby achieving sealing of the balloon 11 .

[0045] Balloon 11 is made of a compliant material, such as at least one of silicone, latex, polyurethane, and polyurethane. This allows it to achieve a larger expanded diameter at relatively low pressures. Furthermore, as pressure increases, its expanded diameter significantly increases, effectively anchoring the balloon 11 after expansion and providing reliable support within the blood vessel. Furthermore, balloon 11 utilizes a tubular wall design that conforms to the outer wall of catheter body 10 in its deflated state, resulting in a smaller outer diameter. This minimizes resistance within the blood vessel and reduces harm to the patient.

[0046] As shown in FIG2 , in some embodiments of the present disclosure, the catheter body 10 includes a main body portion 106 and a tip portion 107 connected to the distal end of the main body portion 106. The instrument passes through the distal ends of the lumen 101 and the pressure monitoring lumen 104 and leads to the side of the tip portion 107, and the balloon catheter passes through the distal end of the lumen 102 and leads to the end surface of the tip portion 107. That is, the diagnostic and treatment instrument can pass through the side of the tip portion 107 of the catheter body 10, and the balloon catheter can pass through the end surface of the tip portion 107 of the catheter body 10.

[0047] The material of the main body 106 can include, for example, at least one of polyamide, polyether block polyamide, acrylonitrile-butadiene-styrene terpolymer, and polyethylene terephthalate. The tip portion 107 can be made of a material that is more flexible than the main body 106, such as at least one of polyurethane, polyurethane, polyether block polyamide, and silicone. The tip portion 107 can be welded to the main body 106. The material selection and shape design of the tip portion 107 can reduce the resistance of the catheter device 100 to passage through the blood vessel, facilitating smoother entry.

[0048] As shown in FIG1 , in some embodiments of the present disclosure, the catheter device 100 may further include a first imaging element 15 disposed on the outer wall of the main body portion 106 and / or a second imaging element 16 disposed on the side of the tip portion 107. During surgery, the imaging element can be detected using external imaging detection equipment (e.g., X-ray detection equipment) to accurately determine its position, enabling precise positioning of the instrument for insertion. The imaging element can be made of one or more materials selected from gold, platinum, iridium, tantalum, tungsten, and the like.

[0049] In the disclosed embodiment, the connector 12 can be made of at least one of acrylonitrile-butadiene-styrene terpolymer, polyamide, polycarbonate, and polyoxymethylene. Connector 12 provides an access channel for other instruments or therapeutic media. Its material is relatively hard compared to the catheter body 10, facilitating assembly and instrument operation. Furthermore, a hemostatic valve can be installed within it.

[0050] As shown in FIG2 , in some embodiments of the present disclosure, the catheter device 100 further includes: a first gland 17 disposed at the port 121; a first hemostatic valve 19 disposed within the port 121 and secured by the first gland 17; a second gland 18 disposed at the first side port 122; and a second hemostatic valve 20 disposed within the first side port 122 and secured by the second gland 18. The hemostatic valves can utilize their own elastic force to squeeze and seal, preventing blood from flowing out and achieving a hemostatic effect. The materials of the first and second hemostatic valves 19, 20 may include, for example, at least one of silicone, latex, polyurethane, and polyurethane.

[0051] The specific structural forms of the first hemostatic valve 19 and the second hemostatic valve 20 are not limited.

[0052] In some embodiments, the first hemostatic valve 19 is a radial compression hemostatic valve with an axial opening, and the first pressure cover 17 cooperates with its outer periphery. When the first pressure cover 17 is tightened, it compresses the outer periphery of the first hemostatic valve 19, causing it to contract and close the hole, thereby achieving a hemostatic effect.

[0053] In some embodiments, the second hemostatic valve 20 is a cross-cut hemostatic valve, which is sheet-shaped and has a cross-cut. In its natural state, the cross-cut is closed. When the balloon catheter passes through the cross-cut, the cross-cut will be pushed open. However, since the hemostatic valve itself has elastic force, it can be squeezed and wrapped around the surface of the balloon catheter, thereby achieving the effect of sealing and hemostasis.

[0054] The present disclosure also provides a heart failure treatment device, comprising the catheter device 100 of any of the aforementioned embodiments.

[0055] The heart failure treatment device may include relevant diagnostic and treatment devices, a balloon catheter, a pump, a pressure sensor, etc. The heart failure treatment device may be used in a venous occlusion treatment program, thereby achieving a good prognosis for the treatment of acute congestive heart failure.

[0056] The treatment implementation cases of the heart failure treatment device according to some embodiments of the present disclosure are as follows:

[0057] First, a channel is established in the femoral vein using a puncture kit, and a guidewire is inserted. Then, the catheter device 100 is introduced into the human body along the guidewire from the femoral vein. The balloon 11 of the catheter device 100 is positioned under angiography in the inferior vena cava, below the renal vein, and the catheter device 100 is fixed.

[0058] Then, a guide wire is inserted into the balloon catheter lumen 102 of the catheter device 100, and the guide wire is passed upward along the inferior vena cava through the heart, superior vena cava, brachiocephalic vein to the subclavian vein; then, the balloon catheter is passed along the guide wire through the balloon catheter lumen 102 to the designated position. During this process, contrast agent can be delivered into the blood vessel through the contrast agent delivery hole of the balloon catheter, so that the balloon of the balloon catheter can accurately reach the occlusion position.

[0059] Afterwards, the catheter device 100 and the balloon catheter are connected to the pressure pumps respectively, and the treatment process begins.

[0060] During the treatment process or before and after treatment, diagnostic and treatment instruments can be inserted through the lumen 101 for relevant testing and treatment. Diagnostic and treatment instruments can be, for example, floating catheters, ablation catheters, etc. In addition, the intravascular pressure can be monitored through the pressure monitoring lumen 104 during treatment.

[0061] It can be seen that for the treatment of venous occlusion, two balloons can be used together to occlude the vein, thereby reducing the blood return from the vein to the heart and alleviating the precardiac load.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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 catheter device, comprising: The catheter body comprises a device passage lumen, a balloon catheter passage lumen, a balloon inflation lumen and a pressure monitoring lumen which are not communicated with each other; A balloon, sealedly connected to the outer wall of the catheter body and communicated with the distal end of the balloon inflation lumen; A connecting seat connected to the proximal end of the catheter body and comprising a port connected to the instrument through a lumen, a first side port connected to the balloon catheter through a lumen, a second side port connected to the balloon inflation lumen, and a third side port connected to the pressure monitoring lumen, wherein the port is used for inserting a diagnostic instrument, and the first side port is used for inserting a balloon catheter; a first side branch tube communicating with the second side port for inputting a balloon inflation medium; and A second side branch pipe communicated with the third side port is used for inputting a pressure monitoring medium.

2. The catheter device according to claim 1, wherein: The catheter body is provided with at least one through hole for connecting the balloon inflation lumen with the balloon, and the balloon is a compliant tube wall balloon which fits with the outer wall of the catheter body in a contracted state.

3. The catheter device according to claim 1 or 2, wherein: The material of the balloon includes at least one of silicone, latex, polyurethane, and polyurethane.

4. The catheter device according to any one of claims 1 to 3, wherein: The instrument passage lumen, the balloon catheter passage lumen, the balloon inflation lumen and the pressure monitoring lumen are respectively in the shape of circular holes, wherein: The center of the cross section of the instrument through the lumen, the center of the cross section of the catheter body, and the center of the cross section of the balloon catheter through the lumen are sequentially arranged along a first straight line direction; The center of the cross section of the balloon inflation lumen and the center of the cross section of the pressure monitoring lumen are arranged in sequence along a second straight line direction orthogonal to the first straight line direction.

5. The catheter device according to claim 4, wherein: The aperture R1 of the lumen through which the instrument passes, the aperture R2 of the lumen through which the balloon catheter passes, the aperture R3 of the balloon inflation lumen and the aperture R4 of the pressure monitoring lumen satisfy: R1>R2>R3=R4.

6. The catheter device according to any one of claims 1 to 5, wherein: The catheter body includes a main body portion and a tip portion connected to the distal end of the main body portion, wherein the instrument leads to the side of the tip portion through a lumen and the distal end of the pressure monitoring lumen, and the balloon catheter leads to the end surface of the tip portion through the distal end of the lumen.

7. The catheter apparatus of claim 6, further comprising: a first developing element disposed on the outer wall of the main body; and / or A second developing member is disposed on a side of the tip portion.

8. The catheter apparatus according to any one of claims 1 to 7, further comprising: a first gland disposed on the port, and a first hemostatic valve disposed in the port and fixed by the first gland; as well as A second pressure cover is provided at the first side port, and a second hemostatic valve is provided in the first side port and fixed by the second pressure cover.

9. The catheter device according to claim 8, wherein: The first hemostatic valve is a radial compression hemostatic valve, and the second hemostatic valve is a cross-cut hemostatic valve.

10. The catheter device according to any one of claims 1 to 10, wherein: The proximal ends of the first side branch tube and the second side branch tube are respectively provided with a Luer connector tee.

11. The catheter device according to any one of claims 1 to 10, wherein: The diagnostic and therapeutic instrument includes an inspection catheter, a floating catheter or an ablation catheter.

12. A heart failure treatment device, comprising: A catheter device according to any one of claims 1 to 11.

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