WO2021254262A1

WO2021254262A1 - Pulmonary artery catheter

Info

Publication number: WO2021254262A1
Application number: PCT/CN2021/099620
Authority: WO
Inventors: 高猛; 许冠哲; 叶乐
Original assignee: 杭州未名信科科技有限公司; 浙江省北大信息技术高等研究院
Priority date: 2020-06-16
Filing date: 2021-06-11
Publication date: 2021-12-23
Also published as: CN111760172A

Abstract

A pulmonary artery catheter (100), comprising: a catheter body (10), which has a head part and a tail part, the catheter body (10) being internally provided with a drug perfusion channel (101) and a balloon inflation channel (102) that are independent from one another, and the catheter body (10) being provided with a drug release hole (103) that communicates with the drug perfusion channel (101); a balloon (11), which is sealedly connected to the head part of the catheter body (10) and communicates with the balloon inflation channel (102); and a sensor (12), which is disposed on the outer wall surface of the catheter body (10) close to the head part and is used to measure the pressure of a pulmonary artery in real time. By integrating the drug perfusion channel (101) and the balloon inflation channel (102), a long-term implantation method or short-term interventional method can be used for pulmonary artery pressure monitoring and pulmonary hypertension targeted drug delivery treatment. The sensor (12) is directly integrated and packaged on the head part of the catheter body (10) to directly measure pulmonary artery pressure, thus the speed of response is fast and measurement is accurate. In addition, the catheter has a compact structure, does not require a guide wire, is small in size, and causes less percutaneous puncture damage.

Description

Pulmonary artery catheter

Technical field

The present invention relates to the field of medical equipment, in particular to a pulmonary artery catheter.

Background technique

Pulmonary hypertension is a highly malignant, extremely difficult to diagnose and incurable pulmonary vascular disease. Ordinary patients will have symptoms such as dyspnea, shortness of breath, suffocation, and hemoptysis. In severe cases, pulmonary artery stiffness, right heart failure or even death will occur. The mortality rate exceeds that of lung cancer and other malignant tumors. According to the statistics of the Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension (2018), the prevalence rate of the general population is 1%, and the prevalence rate is more than 10% for people over 65 years old. There are nearly 30 million patients nationwide, and nearly 12 million patients with severe pulmonary hypertension. Hospitalizations in cardiovascular clinical departments accounted for 6.63%, and the situation is very serious.

The diagnosis of pulmonary hypertension is mainly based on imaging and hemodynamics. Ultrasound/CT/MRI is used to initially diagnose the degree of vascular deformation and vascular wall disease. The hemodynamics of pulmonary artery floating catheter is used to accurately diagnose the final degree of pulmonary hypertension. . This pulmonary artery floating catheter is punctured into the heart through the superior jugular vena cava. The blood-filled catheter directly contacts the external machine's built-in sensor to sense the conduction pressure. The proximal opening of the catheter measures the right atrium pressure, the distal opening measures the pulmonary artery pressure, combined with blood flow measurement. Temperature can also assess cardiac output. It is mainly used in ICU/operating room/cardiac catheterization room to monitor cardiopulmonary blood pressure/blood flow, temperature, blood oxygen, etc. However, this kind of pulmonary artery floating catheter is expensive, integrated with multi-lumen tubing, and large in size. (Outer diameter 2-3mm), large puncture trauma, and intermittent infusion of heparin saline to prevent blood clotting and thrombus (caused by the direct filling of the catheter with blood, which should be replaced at most 5 days), and there are many complications (thrombosis, lung Embolism, arrhythmia, etc.), careless operation can easily cause vascular rupture, which requires doctors to operate.

The treatment of pulmonary hypertension is based on drugs. The poor effect of oral and injected antihypertensive drugs can also easily cause side effects such as edema, vasodilation and rupture, liver and kidney failure. In recent years, the treatment of pulmonary hypertension with catheter intervention and infusion of targeted drugs has received clinical attention. China Statistics from the Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension (2018) show that the three-year survival rate of patients with a confirmed cause after this targeted therapy can be increased from 38.9% to 75.1%.

Summary of the invention

The present invention aims to solve the above-mentioned technical problems in the related art at least to a certain extent. For this reason, the present invention proposes a pulmonary artery catheter.

In order to achieve the above objective, the first aspect of the present invention provides a pulmonary artery catheter, including:

A tube body; has a head and a tail, the tube body is provided with independent drug perfusion channels and balloon inflation channels, and the tube body is provided with a drug release hole communicating with the drug perfusion channel;

A balloon, hermetically connected with the head of the tube body, and connected with the balloon inflation channel;

The sensor is arranged on the outer wall surface of the tube body close to the head, and is used to measure the pressure of the pulmonary artery in real time.

In addition, the above-mentioned pulmonary artery catheter according to the present invention may also have the following additional technical features:

According to an embodiment of the present invention, the drug perfusion channel and the balloon inflation channel are arranged along the length of the tube body, the balloon inflation channel runs through the entire tube body, and the drug perfusion channel starts from the tail. Through a part of the tube body.

According to an embodiment of the present invention, the drug perfusion channel and the balloon inflation channel are integrally formed in the tube body.

According to an embodiment of the present invention, the integral molding process is selected from any of injection molding, extrusion or 3D printing.

According to an embodiment of the present invention, the balloon is hermetically connected to the head of the tube body through a process of over-injection molding, bonding or stitching.

According to an embodiment of the present invention, the pipe body further includes a sensor lead connected to the sensor, and the sensor and the sensor lead are fixed on the outer wall surface of the pipe body by plastic packaging.

According to an embodiment of the present invention, a groove is formed on the outer wall surface of the pipe body, the depth of the groove is smaller than the thickness of the sensor, and the sensor is fixed in the groove.

According to an embodiment of the present invention, the groove is formed on the tube body through a secondary micromachining, primary injection molding, extrusion or 3D printing process.

According to an embodiment of the present invention, the pulmonary artery catheter further includes a protective film for covering the sensing surface of the sensor.

According to an embodiment of the present invention, the thickness of the protective film is nanometer or micrometer, the protective film is selected from biosilica gel or parylene; the material of the tube body and the balloon is selected from polyethylene, Any of polypropylene, nylon, polyether ether ketone, polytetrafluoroethylene, polyoxymethylene, ABS, PBT, or polyphenylene sulfide.

Description of the drawings

By reading the detailed description of the preferred embodiments below, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only used for the purpose of illustrating the preferred embodiments, and are not considered as a limitation to the present invention. Also, throughout the drawings, the same reference symbols are used to denote the same components. In the attached picture:

Figure 1 is a partial longitudinal cross-sectional view of a pulmonary artery catheter in some embodiments of the present invention;

Figure 2 is a cross-sectional view of a pulmonary artery catheter in some embodiments of the present invention.

detailed description

Hereinafter, exemplary embodiments of the present disclosure will be described in more detail with reference to the accompanying drawings. Although the drawings show exemplary embodiments of the present disclosure, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

It should be understood that the terms used in the text are only for the purpose of describing specific example embodiments, and are not intended to be limiting. Unless the context clearly dictates otherwise, the singular forms "a", "an" and "said" as used in the text may also mean that the plural forms are included. The terms "including", "including" and "having" are inclusive and therefore indicate the existence of the stated features, elements and/or components, but do not exclude the existence or addition of one or more other features, elements, and components , And/or their combination.

In the description of the present invention, unless otherwise clearly specified and limited, the terms "set" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be It can be directly connected or indirectly connected through an intermediary. For those skilled in the art, the specific meaning of the above-mentioned terms in the present invention can be understood according to specific circumstances.

In addition, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of these features. In the description of the present invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise specifically defined.

For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature as shown in the figure. These relative terms are, for example, "bottom", "front", and "upper". ", "tilt", "down", "top", "inner", "horizontal", "outer", etc. This spatial relative relationship term is intended to include different positions of the mechanism in use or operation other than those depicted in the figure. For example, if the mechanism in the figure is turned over, then elements described as "below other elements or features" or "below other elements or features" will then be oriented as "above other elements or features" or "below other elements or features" Above features". Therefore, the example term "below" can include an orientation of above and below.

1-2, some embodiments of the present invention provide a pulmonary artery catheter 100, the pulmonary artery catheter 100 includes a tube body 10 with a head and a tail, a balloon 11 and a sensor 12, wherein the tube body 10 and the balloon The material of 11 can be selected from any one of polyethylene, polypropylene, nylon, polyether ether ketone, polytetrafluoroethylene, polyoxymethylene, ABS, PBT or polyphenylene sulfide, and there are independent drugs in the tube body 10 The perfusion channel 101 and the balloon inflation channel 102, the tube body 10 is provided with a drug release hole 103 that communicates with the drug infusion channel 101; the balloon 11 is hermetically connected to the head of the tube body 10, and communicates with the balloon inflation channel 102; The sensor 12 is arranged on the outer wall surface of the tube body 10 close to the head, and is used to measure the pressure of the pulmonary artery in real time.

Specifically, in some embodiments of the present invention, the drug perfusion channel 101 and the balloon inflation channel 102 are arranged along the length of the tube body 10. The balloon inflation channel 102 runs through the entire tube body 10, and the drug perfusion channel 101 runs through the tube from the tail. A part of the body 10, that is, the length of the balloon inflation channel 102 is greater than that of the drug perfusion channel 101.

Further, the drug infusion channel 101 and the balloon inflation channel 102 are integrally formed in the tube body 10 by any one of injection molding, extrusion or 3D printing, and the balloon 11 can be molded, bonded or stitched by over-injection molding. The process is hermetically connected with the head of the tube body 10.

It is worth mentioning that the tube body 10 also includes a sensor lead (not shown in the figure) connected to the sensor 12. The sensor 12 and the sensor lead are integrated and embedded on the outer wall of the tube body 10 through a secondary film plastic encapsulation method. The sensor lead Lead out of the body along the outer wall of the tube body 10. It should be noted that since the sensor 12 has a certain thickness and a pressure sensing surface in direct contact with the blood flow, in order not to increase the tube diameter after the tube body 10 and the sensor 12 are packaged, it can be processed through secondary micromachining, primary injection molding, and extrusion. In a 3D printing process, a groove is formed on the outer wall surface of the tube body 10, and the depth of the groove is less than the thickness of the sensor 12, and the sensor 12 is fixed in the groove by bonding.

In addition, the pulmonary artery catheter 100 also includes a protective film (not shown in the figure) for covering the sensing surface of the sensor 12. The protective film can be used to isolate and protect the sensor 12. The thickness of the protective film is nanometer or micrometer to maximize To reduce the influence of the protective film on the pressure strain of the sensor surface, the material of the protective film is selected from biological silica gel or parylene.

It is worth mentioning that, in the embodiment of the present invention, the balloon 11 is used to float and guide the tube 10 from the right ventricle of the heart into the pulmonary artery. On the one hand, the pulmonary artery blood flow can be cut off for a short time to measure the maximum total pulmonary artery pressure.

During the use of the pulmonary artery catheter 100, the tube body 10 can be implanted into the heart through the superior jugular vena cava, the drug perfusion channel 101 is implanted at the end of the superior jugular vena cava (not into the heart), and the drug perfusion channel 101 is injected under the action of external pump pressure. The drug is released from the drug release hole 103. The drug is released from the end of the superior jugular vena cava and flows through the heart to the pulmonary artery for absorption. The head of the tube 10 is implanted into the pulmonary artery blood vessel, and the sensor is packaged and integrated on the head of the tube 10. Used to monitor the real-time pressure of the pulmonary artery blood flow, the balloon 11 is integrated in the head of the tube 10. After the head of the tube 10 is implanted into the right ventricle of the heart, it is inflated by an extracorporeal air pump (the outer diameter of the balloon does not exceed the blood vessel after inflation). Half of the inner meridian), float to the pulmonary artery under the buoyancy of the right ventricle-pulmonary artery blood flow to reduce the damage of the tube body 10 to the vessel wall (the right ventricle-pulmonary artery vessel becomes thinner and has a bend); in addition, the total pulmonary artery pressure needs to be measured At this time, continue to pressurize and inflate the balloon 11, which can be used to block the blood flow of the pulmonary artery.

Compared with the prior art, the pulmonary artery catheter of the present invention can simultaneously integrate a drug perfusion channel and a balloon inflation channel, and can be implanted for a long time or in a short-term intervention mode for pulmonary artery pressure monitoring and pulmonary hypertension targeted drug delivery treatment, and the sensor can be directly integrated The head encapsulated in the tube body can achieve the effect of directly measuring the pulmonary artery pressure, with fast response speed and accurate measurement, and the catheter has a compact structure, no guide wire, small size, and less percutaneous puncture damage.

The above are only the preferred specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or changes within the technical scope disclosed by the present invention. All replacements shall be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

A pulmonary artery catheter is characterized in that it comprises:

A tube body; has a head and a tail, the tube body is provided with independent drug perfusion channels and balloon inflation channels, and the tube body is provided with a drug release hole communicating with the drug perfusion channel;

A balloon, hermetically connected with the head of the tube body, and connected with the balloon inflation channel;

The sensor is arranged on the outer wall surface of the tube body close to the head, and is used to measure the pressure of the pulmonary artery in real time.
The pulmonary artery catheter according to claim 1, wherein the drug perfusion channel and the balloon inflation channel are arranged along the length of the tube, the balloon inflation channel runs through the entire tube, and the drug The perfusion channel penetrates a part of the tube body from the tail.
The pulmonary artery catheter according to claim 1, wherein the drug perfusion channel and the balloon inflation channel are integrally formed in the tube.
The pulmonary artery catheter according to claim 3, wherein the integral molding process is selected from any of injection molding, extrusion or 3D printing.
The pulmonary artery catheter according to claim 3, wherein the balloon is hermetically connected to the head of the tube body through a process of over-injection molding, bonding or suture.
The pulmonary artery catheter according to claim 1, wherein the tube body further comprises a sensor lead connected to the sensor, and the sensor and the sensor lead are fixed on the outer wall surface of the tube body by plastic sealing superior.
The pulmonary artery catheter according to claim 6, wherein a groove is formed on the outer wall surface of the tube body, and the depth of the groove is less than the thickness of the sensor, and the sensor is fixed in the groove .
The pulmonary artery catheter according to claim 7, wherein the groove is formed on the tube body through a secondary micromachining, primary injection molding, extrusion or 3D printing process.
The pulmonary artery catheter according to claim 7, wherein the pulmonary artery catheter further comprises a protective film for covering the sensing surface of the sensor.
The pulmonary artery catheter according to claim 9, wherein the thickness of the protective film is nanometer or micrometer, and the protective film is selected from the group consisting of biological silica gel or parylene; The material is selected from any one of polyethylene, polypropylene, nylon, polyether ether ketone, polytetrafluoroethylene, polyoxymethylene, ABS, PBT or polyphenylene sulfide.