CN115282436A

CN115282436A - Catheter assembly and device for blood diversion and in-vitro life support system

Info

Publication number: CN115282436A
Application number: CN202110721777.7A
Authority: CN
Inventors: 袁勇; 李建伟; 侯六生; 陈妙莲; 梁宏开; 牛海名
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-05-11
Filing date: 2021-06-28
Publication date: 2022-11-04
Also published as: CN215938702U; CN215938701U; CN115253012A

Abstract

The invention discloses a catheter assembly for blood diversion, comprising: the blood guiding vessel is used for guiding blood, and at least one blood guiding hole is formed in the side wall of the upper part of the blood guiding vessel body; the blood vessel auxiliary body is used for guiding the blood plugging catheter component, and the blood vessel auxiliary body and the blood vessel main body are arranged in parallel and are not communicated with each other; the top opening and the bottom opening of the blood vessel auxiliary body are covered with rubber films, and the rubber films are provided with linear incisions. This a catheter subassembly for blood water conservancy diversion can be used for blood water conservancy diversion and selectivity to place blood shutoff catheter subassembly simultaneously, and nimble strong, and rational in infrastructure, can avoid blood to flow from the blood vessel accessory body, can reduce recirculation phenomenon when this catheter subassembly is used for the ecmo system. The invention also discloses a drainage catheter device and an in vitro life support system which can effectively reduce recirculation.

Description

Catheter assembly and device for blood diversion and in-vitro life support system

Technical Field

The invention relates to the technical field of medical auxiliary instruments, in particular to a catheter assembly and a device for blood diversion and an in-vitro life support system.

Background

Extracorporeal membrane pulmonary oxygenation (ECMO) has a strong cardiopulmonary replacement function, which has been in the clinic for 40 years. With the updating of ECMO devices and the advancement of technology, ECMO has been widely used for the treatment of patients with critical cardiopulmonary failure. The technical principle of ECMO is as follows: firstly, a femoral vein of a patient is cannulated, then venous blood is led out of the body from an inferior vena cava through an 'artificial heart', then the led venous blood is subjected to gas exchange through an 'artificial membrane lung', and the venous blood is changed into arterial blood, namely O ₂ Venous blood and CO ₂ Discharging venous bloodFinally, the oxygenated arterial blood is re-infused back into the patient's body through the femoral artery or the internal jugular vein.

Depending on the mode of blood return to the body, ECMO can be divided into two modes of flow reversal. The first is the venous-arterial mode ECMO (VA-ECMO), which introduces venous blood from the outside of the body through the "artificial heart" and then passes through the "artificial membranefulmonary" to become arterial blood, after which oxygenated hyperoxygenated arterial blood is returned to the patient's body through the femoral artery. The VA-ECMO mode is widely applied to treatment of various cardiogenic shocks, such as acute myocardial infarction, acute fulminant myocarditis, sudden cardiac and respiratory arrest and the like. The second is venous-venous mode ECMO (VV-ECMO), which re-infuses oxygenated hyperoxic arterial blood back into the patient's body through the internal jugular vein, into the right atrial hyperoxic arterial blood through the internal jugular vein, through the right ventricle to the left ventricle, and finally out through the left ventricle for oxygen delivery to participate in systemic circulation. The VV-ECMO mode can improve oxygen transportation of the whole body and improve oxygen supply of tissues and organs, so the VV-ECMO mode is mainly applied to the treatment of severe hypoxemia caused by various respiratory failures, such as severe pneumonia, middle East Respiratory Syndrome (MERS), avian influenza infection of people with H1N1, and COVID-19 critical patients of the worldwide epidemic disease.

The traditional VV-ECMO mode of single-cavity and double-part intubation through femoral vein and internal jugular vein is widely applied to clinic due to simple operation and convenient management. However, the conventional VV-ECMO has the technical defect of 'recycling'. The so-called "recirculation" phenomenon is that the ECMO drainage tube inserted into the inferior vena cava via the femoral vein generates continuous negative pressure suction to the right atrium in order to allow venous blood of the patient to be drained out of the body for gas exchange, so that part of the hyperoxic arterial blood returning to the right atrium via the internal jugular vein is directly drained out of the body again from the inferior vena cava by the ECMO drainage tube, and cannot participate in oxygen delivery of the systemic circulation. The "recirculation" of VV-ECMO can impair the respiratory support efficacy of ECMO, such as the lung of a patient is more diseased, and VV-ECMO is primarily relied on to maintain systemic oxygen supply, such as severe "recirculation" phenomena, which can lead to hypoxemia and can be difficult to correct.

It is generally accepted that the following factors are mainly involved in the VV-ECMO recirculation: 1. the closer the tube ends are, the larger the recirculation quantity is; 2. the sizes of the tube diameters of the ECMO blood leading tube and the blood returning tube are related, and the smaller the tube diameter of the pipeline is, the larger the recirculation quantity is; 3. the higher the rotating speed and the larger the flow, the larger the recirculation amount; 4. the higher the thoracic, abdominal and cardiac pressures are, the larger the amount of recirculation becomes.

To increase the respiratory support effectiveness of VV-ECMO and reduce the risk of ECMO recirculation, recirculation can be reduced by: 1. the method can effectively reduce the recirculation by increasing the tube end distance of the ECMO blood leading tube and the blood returning tube, but the problem of unstable ECMO blood leading tube flow is easy to occur. 2. Although the method can reduce the recirculation, the method is easy to cause insufficient ECMO supporting strength. 3. The diameters of an ECMO blood leading vessel and a blood returning vessel are increased, and although the method can effectively reduce the recirculation, the thick tube intubation is used for patients with thinner blood vessels, so the blood vessel intubation is easy to damage.

The above-described conventional method of reducing the recirculation of VV-ECMO, although capable of reducing the recirculation, has a number of technical drawbacks. Therefore, some foreign scholars try to reduce recirculation more effectively by improving the shape of the ECMO blood return vessel and even changing the way of inserting ECMO into the blood return vessel. These improved methods include: 1. the shape of the ECMO blood return vessel is changed from a straight line shape to a C shape, and then the tip of the blood return vessel is directed to the opening of the tricuspid valve, even the tip of the blood return vessel is directly inserted into the right ventricle or the opening of the pulmonary valve. Although this strategy can reduce recirculation, the risk of damaging the myocardium and even inducing arrhythmia during the catheterization process is somewhat controversial in application. 2. The intubation way of ECMO is changed, the shape of the ECMO blood return tube is improved from a linear type to a 'C' shape, the tip of the blood return tube faces the opening of the tricuspid valve, and meanwhile, the tail end of the blood leading tube is inserted into the superior vena cava and is in a 'chi' shape with the tail end of the blood return tube intubation. Although the method can reduce the recycling, the method is not widely applied clinically due to the problems of complex operation, high difficulty in tube arrangement and the like. 3. Single-site double-lumen venous cannulas, ECMO cervical double cannulas, have been demonstrated to be effective in reducing recirculation, and are now being introduced gradually by developed countries in europe and america. However, the single-tube double-cavity causes the problems of limited pipe flow, high cost and the like, and the wide application of the single-tube double-cavity is limited.

In summary, the conventional single-lumen, dual-site cannulated VV-ECMO via the femoral vein and the internal jugular vein has the technical drawback of recirculation, which significantly impairs the respiratory support efficacy of ECMO and even affects the success rate of treatment. Some effects are obtained after relevant researches of scholars at home and abroad on how to reduce the recycling and the harm of the recycling, but the improvement technology for reducing the recycling is not widely applied for a long time due to the problems of complicated intubation, complication and even cost and the like. It is therefore worth intensive research into how to design simple, safe, efficient devices and methods to reduce recycling.

Disclosure of Invention

In order to overcome the deficiencies of the prior art, it is an object of the present invention to provide a catheter assembly for blood diversion that can be used for both blood diversion and selective placement of a blood occlusion catheter assembly, that is flexible, strong, and structurally sound, that can prevent blood from flowing out of the vascular accessory, and that can reduce recirculation when used on an ecmo system.

It is a further object of the present invention to provide a drainage catheter device which effectively reduces recirculation.

It is a further object of the present invention to provide an extracorporeal life support system in which the blood drainage port employs a catheter assembly for blood drainage as described in one of the objects.

It is a further object of the present invention to provide an extracorporeal life support system, wherein the blood return port employs the catheter assembly for blood drainage.

The fifth objective of the present invention is to provide an extracorporeal life support system, wherein the blood drainage end and the blood return end both adopt the catheter assembly for blood drainage.

One of the purposes of the invention is realized by adopting the following technical scheme:

a catheter assembly for blood diversion, comprising: the blood guiding vessel comprises a blood guiding vessel body for guiding blood, wherein the side wall of the upper part of the blood guiding vessel body is provided with at least one blood guiding hole; a blood vessel auxiliary body used for leading in the blood plugging catheter component, wherein the blood vessel auxiliary body and the blood vessel main body are arranged in parallel and are not communicated with each other; rubber films cover the top opening and the bottom opening of the blood vessel auxiliary body, and linear incisions are formed in the rubber films.

Further, the catheter assembly comprises a double-cavity blood guide tube, wherein the inner cavity of the double-cavity blood guide tube is divided into a blood guide tube main cavity and a blood guide tube side cavity which are mutually isolated, so that the double-cavity blood guide tube forms the blood guide tube main body and the blood guide tube auxiliary body which are not mutually communicated, and a plurality of blood guide holes are formed in the side wall of the upper part of the blood guide tube main body; a side cavity top opening is formed in the top of the blood vessel auxiliary body, a first rubber film covers the side cavity top opening, and a first linear incision is formed in the first rubber film;

the side cavity extension pipe is connected with the tail end of the blood guide pipe auxiliary body and communicated with the blood guide pipe side cavity, a side cavity bottom opening is formed in the tail portion of the side cavity extension pipe, a second rubber film covers the side cavity bottom opening, and a second linear notch is formed in the second rubber film.

Further, the double-cavity catheter comprises a buffer extension tube, wherein the buffer extension tube is arranged at the tail end of the double-cavity catheter and is communicated with the main catheter cavity.

Further, a reinforcing coil is spirally arranged on the inner side wall of the blood vessel main body.

Further, the reinforcing coil is disposed below the blood guide hole and extends spirally to the lower part of the main lumen of the blood guide tube.

Furthermore, the double-cavity blood guide tube is a cylindrical tube body, a cavity-dividing interface is formed in the two-thirds position of the diameter of the double-cavity blood guide tube, and the cavity-dividing interface divides the double-cavity blood guide tube into a blood guide tube main body and a blood guide tube auxiliary body which are not communicated with each other.

Further, the rubber film is covered with an anticoagulation coating.

Further, the thickness of the anticoagulation coating is 0.5-2mm.

Further, the side cavity extension tube extends obliquely outwards from one side of the double-cavity blood guide tube.

Further, the buffering extension pipe is a single-cavity pipe body, and the diameter of the buffering extension pipe is larger than that of the double-cavity blood guide pipe.

Furthermore, the tail part of the buffer extension pipe is provided with a buffer extension pipe tail end interface.

Further, the total length of the double-cavity blood guide pipe and the buffer extension pipe is 55cm, the length of the double-cavity blood guide pipe is 45cm, and the length of the buffer extension pipe is 10cm.

Furthermore, the number of the blood guide holes is 3, and the 3 blood guide holes are vertically arranged on the side wall of the blood guide tube main body in parallel.

Furthermore, the double-cavity blood guide pipe is a polyurethane pipe body, and the buffer extension pipe is a polyurethane pipe body.

The second purpose of the invention is realized by adopting the following technical scheme:

a drainage catheter device effective to reduce recirculation, comprising:

the catheter assembly for blood drainage comprises a blood guide vessel main body and a blood guide vessel auxiliary body which are arranged in parallel and are not communicated with each other, wherein the side wall of the upper part of the blood guide vessel main body is provided with at least one blood guide hole, and the inner side wall of the blood guide vessel main body is spirally provided with a reinforcing coil;

the catheter component comprises a medium tube main body and an introducing tube main body which are arranged in parallel and are not communicated with each other, wherein the upper part of the medium tube main body is provided with a balloon communicated with the medium tube main body, and the balloon can at least cover one part of a vein opening at the drainage end when being expanded; the catheter component for venous blood drainage end plugging movably penetrates into the blood vessel auxiliary body, so that the balloon penetrates out of the top of the blood vessel auxiliary body.

The blood pressure monitoring device further comprises a monitoring component for monitoring blood pressure, wherein a sensing end of the monitoring component is a blood pressure waveform sensing electrode plate which is arranged on the upper part of the inner wall of the main body of the introducing pipe; the inner wall of the leading-in pipe main body extends outwards to be provided with a metal conducting wire, and the metal conducting wire is electrically connected with the sensing end of the monitoring assembly.

Further, the balloon is a visualization balloon.

The third purpose of the invention is realized by adopting the following technical scheme:

an in vitro life support system comprising:

a blood pump and an oxygenator arranged outside the patient body;

the drainage catheter component is arranged in a superior vena cava or an inferior vena cava and used for receiving low-oxygenation blood, and comprises a blood guide vessel main body and a blood guide vessel auxiliary body which are arranged in parallel and are not communicated with each other, wherein the blood guide vessel main body is used for blood drainage, and the blood guide vessel auxiliary body is used for blocking the inlet and outlet of the catheter component; at least one blood guide hole is formed in the side wall of the upper part of the blood guide tube main body; rubber films cover the top opening and the bottom opening of the blood vessel auxiliary body, and linear cuts are formed in the rubber films; the plugging catheter component is used for preventing oxygenated blood from entering a vein opening at the drainage end;

a reflux catheter assembly for oxygenated blood reflux disposed in the superior vena cava or the inferior vena cava.

Further, the occlusion catheter assembly comprises: the medium tube comprises a medium tube main body for medium circulation, wherein a balloon communicated with the medium tube main body is arranged at the upper part of the medium tube main body, and the balloon can at least cover a part of an opening of a vein at a drainage end when being inflated; the medium pipe is at least used for puncture guide wire input, and the medium pipe body are arranged in parallel and are not communicated with each other; the monitoring component is used for monitoring blood pressure, and the sensing end of the monitoring component is arranged on the main body of the introducing pipe.

The fourth purpose of the invention is realized by adopting the following technical scheme:

an in vitro life support system comprising:

a blood pump and an oxygenator arranged outside the patient body;

the backflow conduit component is arranged in the superior vena cava or the inferior vena cava and used for backflow oxygenated blood, the backflow conduit component comprises a blood conduit main body and a blood conduit auxiliary body which are arranged in parallel and are not communicated with each other, and the blood conduit main body is used for backflow of blood; rubber films cover the top opening and the bottom opening of the blood vessel auxiliary body, and linear notches are formed in the rubber films;

a drainage catheter assembly disposed in the superior vena cava or inferior vena cava for receiving low oxygen-synthesized blood.

The fifth purpose of the invention is realized by adopting the following technical scheme:

an in vitro life support system comprising:

a blood pump and an oxygenator arranged outside the patient body;

the drainage catheter assembly is arranged in a superior vena cava or an inferior vena cava and used for receiving low-oxygenation blood, and comprises a blood vessel main body and a blood vessel auxiliary body which are arranged in parallel and are not communicated with each other, wherein the blood vessel main body is used for blood drainage, and the blood vessel auxiliary body is used for blocking the inlet and outlet of the catheter assembly; at least one blood guide hole is formed in the side wall of the upper part of the blood guide tube main body; rubber films cover the top opening and the bottom opening of the blood vessel auxiliary body, and linear notches are formed in the rubber films; the occlusion catheter assembly is used for preventing oxygenated blood from entering a vein opening at the drainage end;

the backflow conduit component is arranged in the superior vena cava or the inferior vena cava and used for backflow oxygenated blood, the backflow conduit component comprises a blood conduit main body and a blood conduit auxiliary body which are arranged in parallel and are not communicated with each other, and the blood conduit main body is used for backflow of blood; rubber films cover the top opening and the bottom opening of the blood vessel auxiliary body, and linear incisions are formed in the rubber films.

Compared with the prior art, the invention has the beneficial effects that:

the catheter assembly for blood diversion provided by the invention has the advantages that the blood vessel main body is used for guiding the fluid to circulate and return blood, and the blood circulates and returns to the ECMO machine for sufficient oxygenation through the blood vessel main cavity. The guide tube auxiliary body and the blood vessel auxiliary body are used for blocking the entrance and exit of the catheter assembly (for example, an entrance and exit channel is provided for a water sac catheter which is used for blocking the right atrium opening of the inferior vena cava). When the catheter assembly is not used, the linear incision on the rubber film is extruded and tightly closed, so that the blood vessel auxiliary body is in a closed vacuum state when not used, and the arrangement mode can ensure that blood cannot flow into the blood vessel auxiliary body in the process of intravenous catheterization. The catheter assembly is simple and novel in structure, high in practicability and good in prospect.

Drawings

Fig. 1 is an overall schematic view of a catheter assembly for venous blood drainage end occlusion according to embodiment 1 of the present invention;

fig. 2 is a view showing the balloon provided in example 1 of the present invention in an inflated state;

FIG. 3 is an enlarged view of the balloon in an inflated state on an occlusion catheter as provided in example 1 of the present invention;

FIG. 4 is a top view of the balloon of the invention provided in example 1 in an inflated state on an occlusion catheter;

FIG. 5 is an enlarged view of the sensing end of the monitoring assembly on the main body of the introducer tube according to embodiment 1 of the present invention;

FIG. 6 is a schematic view of the bifurcation of the occlusion catheter provided in example 1 of the present invention inside the fixator;

fig. 7 is a diagram showing changes in pressure waveform that occur in the pressure waveform receiving and analyzing device during catheterization of the plugging catheter assembly provided in embodiment 1 of the present invention;

FIG. 8 is an assembly view of an occlusion catheter assembly according to example 1 of the present invention in an operative state;

FIG. 9 is another overall schematic view of a catheter assembly for venous blood drainage end occlusion provided in example 1 of the present invention;

fig. 10 is an overall schematic view of a catheter assembly for blood drainage according to example 2 of the present invention;

FIG. 11 is a partial schematic view of a catheter assembly for blood drainage provided in example 2 of the present invention;

FIG. 12 is an assembly view of the drainage catheter device of example 3 of the present invention in an operative condition to effectively reduce recirculation;

FIG. 13 is a schematic view of the tip of a balloon catheter being placed over the tip of an ECMO catheter and at the junction between the inferior vena cava and the right atrium in accordance with an exemplary embodiment of the present invention;

FIG. 14 is a schematic view of the balloon being filled with water and then partially occluding the inferior vena cava in accordance with an exemplary embodiment of the present invention;

FIG. 15 is an ultrasonographic image of the example of the experiment without balloon occlusion of the inferior vena cava;

FIG. 16 is a sonogram demonstrating a significant reduction in the amount of recirculation compared to that before plugging in the experimental examples of the present invention.

In the figure: 1. the top is open; 2. a sensing end; 3. a metal wire; 4. an introducer tube body; 5. a media tube body; 6. a balloon; 7. a side hole; 8. an inflated state balloon; 9. a holder; 10. a fixing hole; 11. a blood pressure sensing lead; 12. a blood pressure sensing lead interface; 13. an introducer bifurcated tube; 14. a medium pipe bifurcated pipe; 15. an introducer tube locking member; 16. a medium pipe locking member; 17. an end interface of the ingress pipe; 18. a medium pipe end interface; 19. a venous vessel opening; 20. the superior vena cava; 21. the inferior vena cava; 22. the right atrium; 23. a vessel main body; 24. a blood vessel auxiliary body; 25. a blood guide hole; 26. the top end of the blood vessel main body is opened; 27. a first rubber film; 28. a first linear cut; 29. the top of the side cavity is opened; 30. a side lumen extension tube; 31. A second rubber film; 32. a second linear cut; 33. a buffer extension tube; 34. buffer the extension pipe end interface.

Detailed Description

The present invention will be further described with reference to the accompanying drawings and the detailed description, and it should be noted that any combination of the embodiments or technical features described below can be used to form a new embodiment without conflict.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", and the like, indicate orientations or positional relationships based on those shown in the drawings, merely for convenience of description and simplicity of description, and do not indicate or imply that the device or element so referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, are not to be construed as limiting the present invention.

The VV-ECMO mode of a single-cavity and double-part intubation through a femoral vein and an internal jugular vein in the prior art has the technical defect of recirculation, the occurrence of recirculation is related to the continuous negative pressure suction of an ECMO blood leading vessel to the blood in the right atrium, for example, if a saccule is applied to the upper part of the tip of the ECMO blood leading vessel to partially block the inferior vena cava, the negative pressure suction of the ECMO blood leading vessel to the blood in the right atrium can be weakened theoretically, and the aim of effectively reducing the recirculation is fulfilled. In view of this assumption, we have devised a balloon catheter specifically for occlusion of the inferior vena cava in an attempt to achieve improved VV-ECMO recirculation through balloon occlusion, as described below.

Example 1

As shown in fig. 1-9, a catheter assembly for venous blood drainage end plugging comprises a medium tube main body 5 for medium circulation, wherein a balloon 6 communicated with the medium tube main body 5 is arranged at the upper part of the medium tube main body 5, and the balloon 6 can cover at least one part of a venous vessel opening 19 at a drainage end when being inflated; when the medium tube main body 5 is used, the medium tube main body 5 is inserted into a patient body and generally enters an inferior vena cava 21 through a femoral vein, finally the saccule 6 is positioned in a right atrium 22 and above an opening of the inferior vena cava 21, when a medium is injected through the medium tube main body 5, the medium reaches the saccule 6 to expand the saccule 6, the expanded saccule 6 at least covers one part of the opening of the inferior vena cava 21, namely, the whole covering and blocking state can be adopted, the partial covering and blocking state can be adopted, the venous opening of a drainage end is at least partially covered through the expanded saccule 6, oxygen-containing arterial blood at a backflow end can be prevented from flowing out from a venous blood drainage end again, the recirculation phenomenon is reduced, the saccule 6 is prepared from a material capable of being developed, the position of the saccule can be judged through the developing technology in the intubation process, and the intubation position can be better and correctly grasped; the medium injected into the medium tube body 5 is most preferably sterile water for injection, and filling the balloon with sterile water for injection ensures that no life-threatening air embolism side effects occur in case of balloon rupture. Of course, the filling medium is not limited to sterilization water for injection, and as the technology is further developed, other kinds of liquid media, even gaseous media, such as air, can be selected to achieve the purpose of the embodiment of the present invention. The catheter assembly further comprises an introducing pipe main body 4 at least used for puncture guide wire input, the introducing pipe main body 4 is not communicated with the medium pipe main body 5, when the catheter assembly is used, the introducing pipe main body 4 is used for puncture guide wire input when a catheter is placed, the introducing pipe main body 4 and the medium pipe main body 5 are simultaneously introduced into a patient body, the introducing pipe main body 4 can also be used for being externally connected with a pressure value measuring sensor, and the pressure value of the right atrium 22 can be measured after the introducing pipe main body 4 is pressurized and dripped by using physiological saline. The catheter assembly further comprises a monitoring assembly for blood pressure monitoring, the sensing end 2 of the monitoring assembly being arranged on the introducer tube body 4.

In a preferred embodiment, the balloon 6 is a visualization balloon, and the balloon 6 is made of a developable material, such as a barium-based material. During actual use, the balloon 6 is developed, so that medical personnel can judge the position of the balloon, and accurate positioning is realized. For example, when the catheter assembly of this embodiment is used in an ecmo treatment, the blood pressure detecting assembly is used for blood pressure monitoring, the catheter can be determined to enter the right atrium through the waveform change of the blood pressure image, and then the balloon is used for positioning, so that whether the balloon reaches the opening of a vein drainage vessel (for example, the inferior vena cava) can be accurately determined, and it is ensured that the balloon 8 in an inflated state can block at least a part of the opening of the vein drainage vessel to prevent oxygenated blood from flowing back to the ecmo system again.

In a preferred embodiment, the catheter assembly comprises an occlusion catheter main body, and a balloon 6 is wrapped around the outer side of the upper part of the occlusion catheter main body; along the extension direction of the plugging catheter main body, the inner cavity of the plugging catheter main body is divided into two parts which are isolated from each other, so that the plugging catheter main body forms a medium pipe main body 5 and an introduction pipe main body 4 which are not communicated with each other; a side hole 7 is formed in the side wall of the upper part of the medium tube main body 5, and the balloon 6 is communicated with the medium tube main body 5 through the side hole 7; leading-in pipe main part 4 is provided with open-top 1, and the inner wall of leading-in pipe main part 4 is provided with wire 3, and the response of monitoring subassembly holds 2 and sets up the inner wall at leading-in pipe main part 4, wire 3 and the response of monitoring subassembly holds 2 electric connection. The medium pipe main body 5 and the leading-in pipe main body 4 are separated at intervals through the inner cavity of the plugging catheter main body, and the plugging catheter main body is of a double-cavity structure, so that the integrity of the arrangement mode is good, and the plugging catheter main body can be conveniently led into a patient. The diameter of the plugging catheter main body can be set to be 3mm (9 Fr), and the diameters of the lumens of the medium tube main body 5 and the introducing tube main body 4 are different and are isolated from each other and are not communicated with each other; the diameter of the guiding tube main body 4 can be 2mm (6F), and the opening of the catheter tube main body is arranged at the top, so that blood flow and puncture guiding guide wires can smoothly pass through the guiding tube main body 4; the diameter of the medium pipe main body 5 can be set to be 1mm (3F), a side hole 7 is formed in the side wall of the upper portion of the medium pipe main body 5, the side hole 7 is formed in the end of the saccule 6, and the saccule 6 can be inflated by injecting water.

In a preferred embodiment, the end of the medium pipe body 5 extends outwardly to form a medium pipe branch pipe 14, the medium pipe branch pipe 14 and the medium pipe body 5 together forming a unitary medium pipe; the tail end of the leading-in pipe body 4 extends outwards to form a leading-in pipe bifurcation 13, and the leading-in pipe bifurcation 13 and the medium pipe body 5 jointly form an integral leading-in pipe; the metal wire 3 extends outwards from the tail end of the guide-in pipe body 4 to form an extension line of the metal wire 3. In use, the occlusion catheter body can be introduced into a patient, while the media tube bifurcation 14, the introduction tube bifurcation 13 and the extension wires of the metal wires 3 are left outside the patient.

In a preferred embodiment, the tail end of the media tube bifurcation 14 is provided with a media tube end interface 18, the media tube end interface 18 is used for guiding the entry of a guide wire by puncture during catheterization and externally connecting a pressure value measuring sensor, and the pressure value of the right atrium 22 can be measured after the pressure drop by using physiological saline through the interface; the tail end of the inlet pipe bifurcated pipe 13 is provided with an inlet pipe tail end interface 17, and the inlet pipe tail end interface 17 is used for injecting water to the saccule 6 and pumping water.

In a preferred embodiment, the tail end of the medium tube branch tube 14 is provided with a first anticoagulant cap, and the tail end of the introduction tube branch tube 13 is provided with a second anticoagulant cap. The tail end of the media tube branch tube 14 and the tail end of the introducing tube branch tube 13 can be twisted and closed by a separate anticoagulant cap, for example, a heparin cap, in the non-use state. Specifically, a heparin cap can be screwed on the medium tube end interface 18 to prevent the medium injection water from flowing out; a heparin cap is screwed on the interface 17 at the tail end of the introducing pipe to prevent the blood from flowing out.

In a preferred embodiment, the sensing end 2 of the monitoring unit is a blood pressure waveform sensing electrode pad. A blood pressure sensing electrode slice made of metal is arranged at a position which is about 1cm below the right of an opening 1 at the top of an ingress pipe main body 4, the blood pressure sensing electrode slice is embedded in the inner wall of the ingress pipe main body 4 and tightly adhered to a guide pipe so as not to be separated, the electrode slice is connected with a metal lead 3 embedded in the wall of the ingress pipe main body 4, an independent metal lead extension line is separated and extended from the inside of a fixer 9, an insulating rubber sheath is coated outside the metal lead extension line to form a blood pressure sensing lead 11, and a blood pressure sensing lead interface 12 is arranged at the tail end of the blood pressure sensing lead 11 and used for being connected with a matched pressure waveform receiving and analyzing device. As the catheter passes or reaches the venous blood vessels and the right atrium 22 during the puncturing procedure, the receiving device may continuously generate corresponding blood flow pressure waveforms to facilitate confirmation of the catheter tip position.

In a preferred embodiment, the medium pipe is further provided with a medium pipe locking piece 16 and an introducing pipe locking piece 15, wherein the medium pipe locking piece 16 is used for blocking the conduction of the medium pipe main body 5, and the introducing pipe locking piece 15 is used for blocking the conduction of the introducing pipe main body 4. More specifically, the medium tube locking member 16 may be disposed on the medium tube bifurcation 14, and after water is injected into the medium tube, the medium tube locking member 16 may be used to fasten the medium tube bifurcation 14 to maintain the filling state of the balloon; an introducer tube locking member 15 may be provided on the introducer tube bifurcation 13, and in use, blood pressure may be measured once every 1-2 hours through the introducer tube body 4, the position may be repeatedly confirmed, and the introducer tube bifurcation 13 may be fastened with the introducer tube locking member 15 after the pressure measurement is completed.

In a preferred embodiment, the medium pipe locking piece 16 is a first locking pipe snap and the introduction pipe locking piece 15 is a second locking pipe snap. The locking piece is arranged to be a buckle, the structure is simple, and the operation is convenient.

As a preferred embodiment, a holder 9; in the situation of use of the catheter assembly, the holder 9 is arranged outside the patient's body for fixation of the catheter assembly. More specifically, the fixator 9 is provided with an upper end opening of the fixator 9 and a lower end opening of the fixator 9, and the plugging catheter main body penetrates out of the upper end opening of the fixator 9; the medium pipe branch pipe 14, the lead-in pipe branch pipe 13 and the metal wire extension line penetrate out from the lower end opening of the fixer 9. The fixer 9 is covered outside the bifurcation part of the catheter and can slide up and down along the catheter. To facilitate the fixation of the holder 9, a fixation means may be provided on the holder 9, for example at least one fixation hole 10 may be provided at the lower end of the holder 9 to facilitate the suture fixation of the holder 9 to the skin surface, thereby achieving a relative fixation of the catheter assembly. In order to improve the fixing stability, the number of the fixing holes 10 is at least two, and the two fixing holes 10 are symmetrically arranged.

In a preferred embodiment, the anchor 9 is a step-like anchor 9, one end face for blocking the exit of the catheter body is a small face, and one end face for the exit of the medium-pipe branch tube 14, the inlet-pipe branch tube 13 and the metal-wire extension line is a large face. The height of the ladder-like holder 9 may be set to 3cm, but may of course also be set to other heights, e.g. 2cm, 4cm, 5cm, etc.

As a preferred embodiment, the outer wall of the balloon 6 is covered with an anti-coagulant coating. The sacculus 6 is made of a barium-based material, preferably, the preparation material comprises nylon 12 and barium sulfate so as to ensure that the sacculus 6 has certain compliance and toughness after being inflated by water injection and can be developed under X rays and severe ultrasound, and the surface of the sacculus 6 is covered with an anticoagulation coating so as to avoid thrombus formation in a region where surface blood flow slowly gathers.

In a preferred embodiment, the balloon 6 is a cylindrical balloon with smooth transitions on each side in the inflated state, and has an oblate shape, and the balloon 8 in the inflated state has a maximum diameter of 3cm and a maximum thickness of 0.5cm. More vividly, the balloon 6 in the inflated state is in the shape of a circular cake. The diameter of the saccule is determined by the water injection amount, the maximum diameter of the saccule after water injection is 3cm, and the maximum thickness is 0.5cm. The right atrium 22 typically measures a radial line of about 40 x 30mm with individual variability, but normal right atrium 22 measures a radial line of no more than 50 x 45mm. The diameter of the whole segment of the inferior vena cava 21 is different and ranges from 1.7 cm to 2.3cm, the diameter of the whole segment of the inferior vena cava can be correspondingly increased or decreased due to disease reasons, and the inferior vena cava 21 is provided with a single semilunar vein valve (Euclidean valve) at the front edge of the opening of the right atrium 22, floats with blood flow and has no obvious structural function. The balloon provided by the embodiment of the invention is arranged according to and by utilizing the structural characteristics of the inferior vena cava 21 and the right atrium 22, so that the vessel wall of the inferior vena cava 21 is prevented from being blocked when the balloon is directly inflated and pressurized, the irreversible damage to the vessel is avoided, and the prognosis of a patient is also prevented from being influenced. The opening of the inferior vena cava 21 in the right atrium 22 is covered and blocked by the disk-shaped saccule 6 which is expanded by water injection, the diameter of the expanded saccule is larger than the maximum diameter of the inferior vena cava 21 of a normal human body, the normal circulation of the right atrium 22 is not influenced by the volume, the expected effect can be achieved, and the unexpected damage to a normal structure is reduced. In the prior art, the balloon is arranged in the venous blood vessel to block the venous blood vessel, and the arrangement mode has the risk of causing pressure damage to the wall of the venous blood vessel.

In a preferred embodiment, the media tube body 5 is a tube body for the circulation of sterile water for injection, and the balloon 6 is a water balloon, and filling the balloon with sterile water for injection ensures that life-threatening air embolism side effects occur in the event of balloon rupture.

In a preferable embodiment, a conical body is formed at the top of the plugging catheter body, and is communicated with the introducing pipe body 4 and isolated from the medium pipe body 5; the top opening 1 of the introducing pipe is arranged at the top end of the conical body; the balloon 6 is wrapped around the upper part of the occlusion catheter body and below the cone, preferably the balloon 6 is wrapped around approximately 2cm below the opening of the tip of the cone (the top opening 1 of the introducer tube). The top of the plugging catheter main body is arranged in a conical shape, so that the plugging catheter main body can be conveniently led into a patient body, when the plugging catheter main body is in a use state, an opening, which penetrates out of a vein, of the top of the conical body is arranged in a right atrium 22, when the plugging catheter main body is in a diastole state, the balloon 6 is not tightly attached to the vein opening 19, and at the moment, the balloon 6 is a small distance away from the vein opening 19; when the heart contracts and the blood return end supplies oxygenated arterial blood to the right atrium 22, the inflated pie-shaped balloon 6 completely covers the opening of the occluded venous vessel.

In a preferred embodiment, the plugging catheter main body, the medium tube bifurcation 14 and the introduction tube bifurcation 13 are made of polyurethane, so that the safety is high, and the preparation is simple; the material of the holder 9, the medium pipe locking element 16, the inlet pipe locking element 15, the medium pipe end connection 18 and the inlet pipe end connection 17 is polycarbonate material, has a certain hardness and is not deformed.

As a preferred embodiment, when the catheter assembly is inserted from the femoral vein, the total length of the catheter assembly may be set to 70cm, 60cm from the tip of the cone (top opening 1 of the introducer tube), and the double lumens may each diverge and extend into two independent, equal length, equal diameter lumen furcations, denoted as media and introducer furcations 14 and 13, respectively. The main body 4 of the introducing tube is provided with a separate blood pressure sensing lead 11 extending outwards, and the blood pressure sensing lead 11 is as long as the bifurcation 13 of the introducing tube. If the catheter assembly is used in the jugular vein, the overall length of the overall assembly may be shortened.

The catheter assembly for venous blood drainage end plugging provided by the embodiment 1 is simple in structure, reasonable in design, safe in material and free of side effects on a human body, and the structure is designed according to the characteristics of the human body organs.

The working principle of the catheter assembly for venous blood drainage end plugging provided by the embodiment 1 is as follows: the opposite femoral vein of the V-V ECMO femoral vein intubation of the patient is used as the puncture point of the water sac catheter in the embodiment of the invention, a guide wire is placed through a steel wire external catheter method (a Seldinger method), and the catheter is placed along the puncture guide wire through an end opening of an introduction tube, an introduction tube branch tube 13, an introduction tube main body 4 and an opening 1 at the top of the introduction tube of the novel water sac double-cavity venous catheter in sequence. According to the "anthropometric methods" and the related literature, the distance between the right femoral vein and the entrance of the inferior vena cava 21 and the right atrium 22Is 33-44cm, therefore, when the catheter enters 30cm, the blood pressure sensing lead interface 12 is connected with a matched pressure waveform receiving and analyzing device, in the process that the water sac venous catheter is continuously preposed, the external device can continuously generate a corresponding pressure waveform change image along with the blood pressure waveform sensing electrode slice which is 1cm below the right of the tip of the catheter and continuously senses the blood flow pressure change, when the pressure waveform shows a special sine waveform of the right atrium 22 (fig. 7, a wave is a contraction waveform of the right atrium 22, c wave is a waveform that the tricuspid valve moves to the right atrium 22, and v wave is a filling waveform of the right atrium 22), the fact that the tip opening reaches the atrium 22 is indicated, and physiological saline is pressurized and dripped through the tail end opening of the catheter, the pressure value of the atrium 22 can be specifically measured, and the pressure value of the atrium 22 can be specifically measured at 0-10cmH ₂ The arrival of the catheter tip (cone tip) at the right atrium 22 is also confirmed in the O range. To ensure safety for the patient, the position of the blood pressure waveform sensing electrode pad near the catheter tip and the position of the balloon 6 are displayed by the bedside ultrasonic machine and the bedside X-ray film, and it is further confirmed that the catheter tip reaches the right atrium 22. Then injecting sterilization injection water into the end opening of the medium tube to expand the balloon into a round cake shape, wherein the round cake-shaped balloon naturally covers and blocks the opening of the right atrium 22 of the inferior vena cava 21, and after injecting water, the medium tube bifurcated tube 14 can be fastened by the medium tube locking piece 16 to maintain the filling state of the balloon. The pressure can be measured once every 1-2 hours through the leading-in pipe main body 4, the position is repeatedly confirmed, and the leading-in pipe locking piece 15 is used for fastening the media pipe branch pipe 14 after the pressure measurement is finished; the introducer and media

tube furcation tubes

13 and 14 can be twist-closed with separate heparin caps in the non-use state.

The catheter assembly for venous blood drainage end plugging provided by the embodiment 1 can also be used for drug delivery, and when the drug delivery is carried out, the drug is fed through the introduction tube main body 4, and finally the drug is output from the top opening 1 of the introduction tube main body 4.

Example 2

As shown in fig. 10 to 12, a catheter assembly for blood transfusion includes a blood vessel main body 23 for blood transfusion and a blood vessel auxiliary body 24 for blood occlusion catheter assembly introduction. At least one blood guide hole 25 is formed in the side wall of the upper portion of the blood guide tube main body 23, the blood guide hole 25 is used for guiding body circulation backflow blood, and the body circulation backflow blood flows to an ECMO machine through the blood guide tube main cavity to be fully oxygenated; the vessel sub-body 24 and the vessel main body 23 are arranged in parallel and are not communicated with each other; rubber films are covered on the top opening and the bottom opening of the blood vessel auxiliary body 24, and linear incisions are formed in the rubber films. In the non-use state of the catheter assembly, due to the elastic extrusion property of rubber, the linear incision on the rubber film is tightly extruded, so that the blood vessel auxiliary body 24 is in a closed vacuum state when not in use, the arrangement mode can ensure that blood does not flow into the blood vessel auxiliary body 24 during the vein catheterization process, but a plugging water sac catheter (such as the plugging catheter of embodiment 1) needs to be placed into the body through the blood vessel auxiliary body 24, the linear incision on the rubber film at the top of the blood vessel auxiliary body 24 and the linear incision on the rubber film at the bottom of the blood vessel auxiliary body 24 can be spread, so that the plugging catheter can conveniently enter from the linear incision at the bottom of the blood vessel auxiliary body 24 and pass through the linear incision at the top of the blood vessel auxiliary body 24 to finally reach the inferior vena cava 21 or the superior vena 20.

The blood vessel main body 23 provided in embodiment 2 of the present invention is mainly used for guiding blood, for example, for leading out venous blood, and the blood vessel auxiliary body 24 is mainly used for plugging the smooth passage of the water sac catheter at the opening of the right atrium 22 of the inferior vena cava 21, and is an access passage of the water sac catheter.

As a preferred embodiment, the catheter assembly comprises a double-cavity blood guide tube, wherein the inner cavity of the double-cavity blood guide tube is divided into a blood guide tube main cavity and a blood guide tube side cavity which are isolated from each other, so that the double-cavity blood guide tube forms a blood guide tube main body 23 and a blood guide tube auxiliary body 24 which are not communicated with each other, and a plurality of blood guide holes 25 are formed in the side wall of the upper part of the blood guide tube main body 23; a side cavity top opening 29 is formed at the top of the blood vessel auxiliary body 24, a first rubber film 27 covers the side cavity top opening 29, and a first linear incision 28 is formed in the first rubber film 27; namely, the vessel guiding main body 23 and the vessel guiding auxiliary body 24 are formed by separating the inner cavities through a tube, and have good integrity and convenient clinical operation. The catheter assembly further comprises a side cavity extension tube 30, the side cavity extension tube 30 is connected with the tail end of the blood guide tube auxiliary body 24 and communicated with the side cavity of the blood guide tube, a side cavity bottom opening is formed in the tail portion of the side cavity extension tube 30, a second rubber film 31 covers the side cavity bottom opening, and a second linear cut 32 is formed in the second rubber film 31; when the blocking water sac catheter needs to be placed into the body from the blood vessel auxiliary body 24, the blocking catheter enters from the first linear incision 28 on the side cavity extension tube 30, passes through the side cavity extension tube 30 and the blood vessel auxiliary body 24 in sequence, then passes out from the second linear incision 32 on the blood vessel auxiliary body 24, and finally reaches the inferior vena cava 21 or the superior vena cava 20. When the catheter assembly is in a non-use state, the first linear incision 28 and the second linear incision 32 are tightly pressed due to the elastic pressing property of the rubber, so that the blood vessel auxiliary body 24 is in an airtight vacuum state when not in use. This arrangement ensures that blood does not flow into the vessel appendage 24 during intravenous administration.

In a preferred embodiment, the catheter assembly further comprises a buffer extension tube 33, and the buffer extension tube 33 is arranged at the tail end of the double-cavity blood guide tube and is communicated with the main cavity of the blood guide tube. Preferably, the buffer extension tube 33 is a single-lumen tube, and the diameter of the buffer extension tube 33 is larger than that of the double-lumen blood catheter. The diameter of the buffer extension tube 33 is slightly larger than that of the double-cavity blood guide tube, and when the buffer extension tube 33 is used, the buffer extension tube 33 does not enter the blood vessel of a human body. The tail part of the buffer extension pipe 33 is provided with a buffer extension pipe tail end interface 34. The main functions of the buffer extension tube 33 include: during the ECMO catheterization process, a guide wire is guided through puncture, and the tail end interface 34 of the external buffer extension tube is connected with the ECMO conveying blood pipeline.

In a preferred embodiment, the inner wall of the blood vessel main body 23 is spirally provided with a reinforcing coil, and more preferably, the reinforcing coil is arranged below the blood guide hole 25 and spirally extends to the lower part of the main lumen of the blood vessel. The even spiral coil of reinforcing coil is around on the inside wall of leading blood vessel main part 23, plays the support and keeps the main cavity structure, maintains the unobstructed effect of blood flow.

In a preferred embodiment, the dual-lumen catheter is a cylindrical tube, and a lumen interface is formed at two thirds of the diameter of the dual-lumen catheter, and the lumen interface divides the dual-lumen catheter into a catheter main body 23 and a catheter auxiliary body 24 which are not communicated with each other. The top openings of the main vessel cavity and the side vessel cavity are on the same horizontal plane, the cross sections of the two openings are two semicircles, one big and one small, the cross section area of the main vessel cavity is larger than that of the side vessel cavity, and the two open cross sections form a circular section.

As a preferred embodiment, the rubber membrane is covered with an anticoagulant coating formed from an anticoagulant composition, which may include heparin, for example. The anticoagulant coating prevents blood that flows through and collects near the top of the vessel appendage 24 from forming a thrombus.

As a preferred embodiment, the thickness of the anticoagulant coating is 0.5-2mm, and may be selected from one of 0.5mm, 0.8mm, 1mm, 1.2mm, 1.5mm, 1.8mm, and 2mm, or other reasonable thicknesses.

In a preferred embodiment, the side lumen extension tube 30 extends obliquely outward from one side of the double lumen catheter and may extend for a length of 2-20cm, preferably 2-10cm, and more preferably 3cm. During the tube placement, the side-lumen extension tube 30 is placed outside the patient's body and does not enter the patient's body.

In a preferred embodiment, the total length of the double lumen blood guide tube and the buffer extension tube 33 is 55cm, the length of the double lumen blood guide tube is 45cm, and the length of the buffer extension tube 33 is 10cm.

In a preferred embodiment, the number of the blood conduction holes 25 is 3, and 3 blood conduction holes 25 are vertically arranged in parallel on the side wall of the blood conduction vessel main body 23. The 3 blood guide holes 25 are used for guiding the body circulation backflow blood, the body circulation backflow blood flows to the ECMO machine through the main cavity of the blood guide tube for sufficient oxygenation, and the blood guide tube mainly depends on siphon and attraction to guide the blood flowing back from the inferior vena cava 21, so that the three blood guide holes 25 can prevent the shearing force generated by the wall attachment of the catheter from influencing the flow rate and the flow velocity of the drainage blood.

In a preferred embodiment, the double-lumen blood guide tube and the buffer extension tube 33 are both made of polyurethane material, so that the safety is high and the manufacturing is simple.

The catheter assembly provided in embodiment 2 of the present invention is preferably used for a venous blood drainage end, for example, for the inferior vena cava 21 to drain venous blood from the inferior vena cava 21 to the outside as a drainage tube. The catheter assembly may also be used in the superior vena cava 20, and may even be used as a blood return line, depending on the actual medical needs. When the catheter assembly provided by the embodiment of the invention is introduced from the femoral vein, in the process of catheterization before the use of the ECMO, the puncture guide wire can pass through the blood vessel main body 23 in sequence and penetrate out from the top opening of the blood vessel main body 23, so that the blood vessel main body 23 and the blood vessel auxiliary body 24 are ensured to reach the inferior vena cava 21 through the femoral vein, and at the moment, the V-V ECMO can be operated for treatment; or the V-V ECMO can be operated to treat the disease after the vessel auxiliary body 24 is placed into the blocking water sac catheter. The plugging water sac catheter can be the catheter component used for plugging the venous blood drainage end in the embodiment 1.

Example 3

As shown in fig. 12, example 3 provides a drainage catheter device effective in reducing recirculation, which is mainly composed of two major parts: a catheter component for sealing off a venous blood drainage end and a catheter component for blood diversion. The plugging catheter component is detachably and movably arranged on the blood diversion component. Preferably, the catheter assembly for venous blood drainage end plugging is an independent water sac catheter which can precisely plug the opening of the right atrium 22 of the inferior vena cava 21. The catheter assembly for blood diversion is a double-lumen ECMO blood-leading catheter. The scheme is described as follows.

A drainage catheter device effective to reduce recirculation, comprising:

the catheter assembly for blood drainage comprises a blood vessel guiding main body 23 and a blood vessel guiding auxiliary body 24 which are arranged in parallel and are not communicated with each other, wherein the side wall of the upper part of the blood vessel guiding main body 23 is provided with at least one blood guiding hole 25;

the catheter component for plugging the venous blood drainage end comprises a medium tube main body 5 and an introducing tube main body 4 which are arranged in parallel and are not communicated with each other, wherein the upper part of the medium tube main body 5 is provided with a balloon 6 communicated with the medium tube main body 5, and the balloon 6 can at least cover one part of a venous blood vessel opening 19 of the drainage end when being expanded;

the catheter component for sealing the venous blood drainage end movably penetrates into the blood vessel auxiliary body 24, so that the saccule penetrates out of the top of the blood vessel auxiliary body 24.

The catheter assembly for plugging the venous blood drainage end further comprises a monitoring assembly for monitoring blood pressure, and the sensing end 2 of the monitoring assembly is arranged on the introducing pipe body 4.

The structural components, the connection relationship of the components and the preferred arrangement scheme of the catheter assembly for venous blood drainage end occlusion in the embodiment 3 are shown in the embodiment 1, which has been described in detail in the embodiment 1, and are not described in detail in the embodiment 3.

The structural components, the connection relationship of the components and the preferred arrangement of the catheter assembly for blood drainage in example 3 are shown in example 2, and the detailed description of example 2 is given, and will not be repeated in example 3.

Example 3 provides a drainage catheter device with effective reduced recirculation operating principle as follows:

when a patient is ready for VV-ECMO treatment, a corresponding femoral vein is selected as an insertion puncture point of the catheter set of the design, a blood guide main body 23 and a blood guide auxiliary body 24 of the double-cavity ECMO blood guide tube are pre-flushed to ensure that two cavities are filled with normal saline, a guide wire is inserted through a steel wire external tube method (a Seldinger method), and the blood guide main body 23 of the ECMO blood guide tube sequentially passes through the double-cavity ECMO blood guide tube along the puncture guide wire and penetrates out from an opening 26 at the top end of the blood guide main body to ensure that the double-cavity ECMO blood guide tube is inserted into a lower vena cava 21, and V-V ECMO can be operated for treatment; or the V-V ECMO can be operated to treat the disease after the vessel auxiliary body 24 is placed into the blocking water sac catheter.

The water sac catheter for plugging the right atrium 22 of the inferior vena cava 21 can firstly open a second linear incision 32 on a second rubber film 31 at the tail end of a side cavity extension tube 30 of the double-cavity ECMO blood-leading catheter, the water sac plugging catheter is slowly sent into a side cavity of a blood-leading vessel of the double-cavity ECMO blood-leading catheter until the tip of the water sac catheter reaches the second rubber film 31 of the side cavity opening of the double-cavity ECMO blood-leading vessel, the second linear incision 32 on the second rubber film 31 is opened, the water sac catheter reaches the inferior vena cava 21 through a blood-leading vessel auxiliary body 24 of the double-cavity ECMO blood-leading catheter, at the moment, a conical body and the following small part of the water sac plugging catheter are positioned in the inferior vena cava 21, the rest part of a main body of the water sac plugging catheter is positioned in the side cavity of the double-cavity ECMO blood-leading vessel, and a bifurcated catheter is left outside the body.

According to "measurement of the human bodyMethod and related documents, the distance between the right femoral vein and the entrance of the inferior vena cava 21 and the right atrium 22 is 33-44cm, therefore, when the catheter enters 30cm, the blood pressure sensing lead interface 12 is used to connect a matched pressure waveform receiving and analyzing device, in the process that the water sac venous catheter is continuously preposed, the external device can continuously generate a corresponding pressure waveform change image along with the continuous sensing of blood pressure changes of a blood pressure waveform sensing electrode plate at the lower right 1cm of the tip of the catheter (fig. 7, a wave is a right atrium 22 contraction wave, c wave is a tricuspid valve moving to the atrium 22 wave, and v wave is an atrium 22 filling wave) when the pressure waveform is expressed as a special sine wave of the right atrium 22, which indicates that the tip opening of the water sac catheter reaches the right atrium 22, and physiological saline is pressurized and dripped through the tail end opening of the introducer catheter, the pressure value of the right atrium 22 can be specifically measured, and the pressure value is 0-10cmH ₂ The arrival of the catheter tip (cone tip) at the right atrium 22 is also confirmed in the O range. To ensure safety for the patient, the position of the blood pressure waveform sensing electrode pad near the catheter tip and the position of the balloon 6 are displayed by the bedside ultrasonic machine and the bedside X-ray film, and it is further confirmed that the catheter tip reaches the right atrium 22. Then injecting sterilization injection water into the opening at the tail end of the medium tube to expand the balloon into a round cake shape, wherein the round cake-shaped balloon naturally covers and seals the opening of the right atrium 22 of the inferior vena cava 21, and after water injection, the medium tube locking piece 16 can be used for fastening the medium tube bifurcated tube 14 to maintain the filling state of the balloon. The pressure can be measured once every 1-2 hours through the leading-in pipe main body 4, the position is repeatedly confirmed, and the leading-in pipe locking piece 15 is used for fastening the media pipe branch pipe 14 after the pressure measurement is finished; the introducer and media

tube furcation tubes

13 and 14 can be twist-closed with separate heparin caps in the non-use state.

Example 4

An in vitro life support system comprising:

a blood pump and an oxygenator arranged outside the patient body;

a drainage catheter assembly for receiving hypooxygenated blood disposed in the superior vena cava 20 or inferior vena cava 21, the drainage catheter assembly comprising a drainage tube for blood drainage, the catheter assembly for sealing the drainage end of the venous blood passing into the drainage tube, the balloon 6 passing out of the top of the drainage tube, the balloon 6 being capable of expanding to cover at least a portion of the venous opening 19 of the drainage end;

a reflux catheter assembly is provided in the superior vena cava 20 or inferior vena cava 21 for oxygenated blood reflux.

The extracorporeal life support system provided in example 4 can prevent the oxygenated blood returning from the ecm system from entering the venous blood drainage port opening by removably attaching a blocking catheter assembly to the drainage catheter assembly for receiving the hypoxic blood, thereby reducing recirculation.

The structural components, the connection relationship of the components and the preferred arrangement scheme of the catheter assembly for sealing the venous blood drainage end in the embodiment 4 are as shown in the embodiment 1, which are already described in detail in the embodiment 1, and are not described in detail in the embodiment 4. The drainage tube for blood drainage in example 4 is not particularly limited, but it is naturally practical to design the drainage tube according to the used plugging catheter assembly, and for example, the catheter assembly for blood drainage provided in example 2 can be used.

Example 5

An in vitro life support system comprising: a blood pump and an oxygenator arranged outside the patient body; a drainage catheter device disposed in the superior vena cava 20 or inferior vena cava 21 for receiving hypooxygenated blood; and a reflux catheter assembly disposed in the superior vena cava 20 or the inferior vena cava 21 for oxygenated blood reflux.

The drainage catheter device of example 5 is preferably the drainage catheter device of example 3 which can effectively reduce recirculation, and the device mainly comprises a catheter component for venous blood drainage end sealing and a catheter component for blood drainage, and the connection relationship of the two components is described in example 3 and is not described herein.

In addition, the structural components, the connection relationship of the components and the preferred arrangement scheme of the catheter assembly for venous blood drainage end occlusion in example 5 are shown in example 1, which has been described in detail in example 1, and are not repeated in this example 5.

The structural components, the connection relationship of the components, and the preferred arrangement of the catheter assembly for blood drainage in example 5 are shown in example 2, and are described in detail in example 2, and are not described in detail in example 5.

Example 6

An in vitro life support system comprising:

a blood pump and an oxygenator arranged outside the patient body;

the drainage catheter component is arranged in the superior vena cava 20 or the inferior vena cava 21 and used for receiving low-oxygenation blood, the drainage catheter component comprises a blood guide vessel main body 23 and a blood guide vessel auxiliary body 24 which are arranged in parallel and are not communicated with each other, the blood guide vessel main body 23 is used for blood drainage, and the blood guide vessel auxiliary body 24 is used for blocking the inlet and outlet of the catheter component; at least one blood guide hole 25 is arranged on the side wall of the upper part of the blood guide tube main body 23; rubber films are covered on the top opening and the bottom opening of the blood vessel auxiliary body 24, and linear notches are formed in the rubber films; the plugging catheter component is used for preventing oxygenated blood from entering a vein opening 19 at the drainage end;

a return line assembly disposed in the superior vena cava 20 or inferior vena cava 21 for oxygenated blood return.

In the extracorporeal life support system provided in example 6, the drainage catheter assembly is of a novel design, and when performing the eco therapy, the main vessel body 23 is used for blood drainage, and the auxiliary vessel body 24 is used for blocking the access of the catheter assembly, which is the access passage of the catheter assembly.

The structural components, connection relationships of the components, and preferred arrangement of the drainage catheter assembly for receiving hypooxygenated blood in example 6 are shown in example 2, and are described in detail in example 2, and are not described in detail in example 6.

The specific structure of the catheter assembly for occlusion in example 6 is not limited, but it is preferable that the catheter assembly for occlusion of the venous blood drainage end provided in example 1, in which the venous blood vessel opening 19 at the drainage end is covered and occluded by the inflated balloon 6. However, the plugging principle is not limited to the embodiment of example 1, as long as it can prevent the oxygenated blood from entering the vein opening 19 at the drainage end. For example, although the occlusion is performed by a balloon, the occlusion position is not at the opening of the drainage end of the vein, and the balloon is not disposed above the opening of the vein but disposed in the vein, as long as the occlusion of the oxygenated blood from the drainage end of the vein is prevented.

Example 7

An in vitro life support system comprising:

a blood pump and an oxygenator arranged outside the patient body;

a reflux catheter component which is arranged in the superior vena cava 20 or the inferior vena cava 21 and used for oxygenating blood by back and forth flow, the reflux catheter component comprises a blood guide main body 23 and a blood guide auxiliary body 24 which are arranged in parallel and are not communicated with each other, and the blood guide main body 23 is used for blood reflux; rubber films are covered on the top opening and the bottom opening of the blood vessel auxiliary body 24, and linear incisions are formed in the rubber films;

a drainage catheter assembly disposed in the superior vena cava 20 or inferior vena cava 21 for receiving low oxygen-containing blood.

In the extracorporeal life support system provided in example 7, the reflux catheter assembly is of a novel design, and the main vessel 23 is used for blood reflux during the ecmo treatment. The structural components, the connection relationship of the components, and the preferred arrangement of the reflux tube assembly for oxygenating blood by back-and-forth flow in embodiment 7 are shown in embodiment 2, and are described in detail in embodiment 2, and are not described in detail in embodiment 7.

In addition, the vessel auxiliary body 24 can be used for placing other suitable medical devices, for example, for blocking the entrance and exit of the catheter assembly, which is the entrance and exit passage of the catheter assembly, the catheter assembly is used for controlling the blood flow perfused into the right atrium 22 of the patient, the state of the catheter assembly should be adjustable, the amount of the oxygenated blood flowing back to the right atrium 22 is changed by adjusting the state of the catheter assembly, and the catheter assembly is not necessarily the water sac catheter provided in example 1, and can be designed reasonably according to actual needs. However, depending on the actual medical level and actual requirements, the vessel appendage 24 may house other types of medical devices, even no medical devices.

Example 8

An in vitro life support system comprising:

a blood pump and an oxygenator arranged outside the patient body;

the drainage catheter component is arranged in the superior vena cava 20 or the inferior vena cava 21 and used for receiving low-oxygenation blood, and comprises a blood vessel guiding main body 23 and a blood vessel guiding auxiliary body 24 which are arranged in parallel and are not communicated with each other, wherein the blood vessel guiding main body 23 is used for blood drainage, and the blood vessel guiding auxiliary body 24 is used for plugging the catheter component to enter and exit; at least one blood guide hole 25 is arranged on the side wall of the upper part of the blood guide tube main body 23; rubber films are covered on the top opening and the bottom opening of the blood vessel auxiliary body 24, and linear notches are formed in the rubber films; the plugging catheter component is used for preventing oxygenated blood from entering a vein opening 19 at the drainage end;

a reflux catheter component which is arranged in the superior vena cava 20 or the inferior vena cava 21 and used for oxygenating blood by back and forth flow, the reflux catheter component comprises a blood guide main body 23 and a blood guide auxiliary body 24 which are arranged in parallel and are not communicated with each other, and the blood guide main body 23 is used for blood reflux; rubber films are covered on the top opening and the bottom opening of the blood vessel auxiliary body 24, and linear incisions are formed in the rubber films.

In the extracorporeal life support system provided in example 8, the drainage catheter assembly is designed in a novel way, and when performing the ecmo treatment, the main vessel body 23 is used for blood drainage, and the auxiliary vessel body 24 is used for blocking the access of the catheter assembly, which is the access passage of the catheter assembly. The structural components, the connection relationship of the components, and the preferred arrangement of the drainage catheter assembly for receiving hypooxygenated blood in example 8 are shown in example 2, and the detailed description of example 2 is given, and will not be repeated in this example 8. In example 8, the specific structure of the catheter assembly for sealing drainage vessels is not limited, but the catheter assembly for sealing drainage end of venous blood provided in example 1 is preferred, and in this case, the opening 19 of venous blood vessel at the drainage end is sealed by covering with the balloon 6 which is inflated. However, the occlusion principle is not limited to the solution of example 1, as long as it blocks the oxygenated blood from entering the drainage end venous vessel opening 19. For example, although the occlusion is performed by a balloon, the occlusion position is not at the opening of the drainage end of the venous blood vessel, and the balloon is not disposed above the opening of the venous blood vessel but disposed in the venous blood vessel as long as the occlusion of the entry of oxygenated blood into the drainage end of the venous blood vessel can be prevented.

In the extracorporeal life support system provided in example 8, the reflux catheter set is of a novel design, and the blood vessel main body 23 is used for blood reflux when performing the eco therapy. The structure, connection and preferred arrangement of the reflux catheter assembly for back-and-forth flow oxygenation of blood in example 8 are shown in example 2, and the detailed description of example 2 is given, and will not be repeated in this example 8. In addition, the vessel auxiliary body 24 on the reflux catheter assembly can be used for placing other suitable medical devices, for example, for blocking the in and out of the catheter assembly, i.e., for blocking the in and out passage of the catheter assembly, the blocking catheter assembly is used for controlling the blood flow perfused into the right atrium 22 of the patient, in which case the state of the blocking catheter assembly should be adjustable, and the amount of oxygenated blood refluxed into the right atrium 22 is changed by adjusting the state of the blocking catheter assembly, in which case the blocking catheter assembly is not necessarily the water sac catheter provided in embodiment 1, and can be designed reasonably according to actual requirements. However, depending on the actual medical level and actual requirements, the vessel appendage 24 may house other types of medical devices, even without any medical devices.

Example 9

A method of intubation for ECMO treatment, comprising the steps of:

a blood guiding tube assembly is inserted into the superior vena cava 20 or the inferior vena cava 21, the blood guiding tube assembly is used for receiving low-oxygen blood, a balloon 6 is arranged on the blood guiding tube assembly, the balloon 6 penetrates out of the opening of the vein and is placed above the opening of the vein, and the balloon 6 can at least cover a part of the drainage end vein opening 19 when being expanded. During use, when the heart relaxes, the balloon 6 is not tightly attached to the venous vessel opening 19, and the balloon 6 is at a short distance from the venous vessel opening 19; when the heart contracts and the blood return end supplies oxygen-containing arterial blood to the right atrium 22, the balloon 8 in the expanded state completely covers the opening for blocking the venous blood vessel.

The vessel guiding component inserted into the superior vena cava 20 or inferior vena cava 21 is preferably the drainage catheter device capable of effectively reducing recirculation provided by embodiment 3, the device mainly comprises a catheter component for sealing the venous blood drainage end and a catheter component for guiding blood, and the connection relationship of the two components is already described in embodiment 3 and is not described in detail herein.

The structural components, the connection relationship of the components and the preferred arrangement scheme of the catheter assembly for venous blood drainage end occlusion in example 9 are shown in example 1, which has been described in detail in example 1, and are not described again in example 9.

The structural components, the connection relationship of the components, and the preferred arrangement of the catheter assembly for blood drainage in example 9 are shown in example 2, which has been described in detail in example 2, and will not be described again in example 9.

Effect verification

The following experiments were performed in the national hospital, zhongshan city, guangdong province, in the following specific operating modes: the applicant clinically designs a balloon catheter special for blood vessel occlusion, a balloon capable of filling water is arranged at the top end of the catheter, and the balloon catheter is placed above the tip of an ECMO (endothelial cell) drainage vessel and in the opening of the right atrium under the guidance of ultrasound. The applicant places a tube in the femoral vein on the opposite side of the ECMO cannula by performing femoral vein puncture with a Seldinger method, places the top end of a balloon catheter above the tip of the ECMO cannula and at the junction of the inferior vena cava and the right atrium of the ECMO cannula under ultrasonic guidance (figure 13), partially blocks the inferior vena cava after the balloon is filled with water (figure 14), and partially blocks the pulmonary artery SvO of a patient after blocking ₂ From 77% to 92% (Table 1), radial PaO ₂ /FiO ₂ From 58 to 103mmHg (Table 2), the hemodynamic index fluctuated but quickly returned to normal levels (Table 3), and a review of ultrasound imaging confirmed a significant reduction in the amount of recirculation (FIG. 16) compared to that before occlusion (FIG. 15). The research result indicates that the method not only can effectively reduce the recirculation, but also has the advantages of simple operation, low cost, short-term application safety and the like, and is expected to become an ideal method for reducing the VV-ECMO recirculation.

TABLE 1 analysis of the change of mixed venous blood gas before and after filling the balloon catheter with water

	Before filling with water	5min after water filling
			pH	7.42	7.43
PO ₂ (mmHg)	41	63
			PCO ₂ (mmHg)	39.8	40.7
SvO ₂ (％)	77	92
			HCO ₃ ^- (mmol/L)	25.8	25.7

As can be seen from the record in Table 1, pulmonary artery mixed venous blood PO was obtained after the balloon catheter was filled with water to partially occlude the inferior vena cava ₂ 、 SvO ₂ Is obviously increased.

TABLE 2 analysis of radial blood gas changes before and after balloon catheter is filled with water

	Before filling with water	5min after water filling
			PH	7.42	7.43
PO ₂ (mmHg)	58	103
			PCO ₂ (mmHg)	37.9	42.5
SaO ₂ (％)	89	98
			HCO ₃ ^- (mmol/L)	25.1	28.5

From the data in table 2, it can be seen that radial blood PO2 and SaO2 increased significantly after the balloon catheter was filled with water to partially occlude the inferior vena cava.

TABLE 3 change of hemodynamic index before and after balloon catheter is filled with water

From the records in table 3, HR, BP, mPAP, PAWP, CO increase after partial occlusion of the inferior vena cava by balloon catheter filling.

As can be seen from fig. 15-16, after the balloon catheter is filled with water to partially block the inferior vena cava, ultrasound imaging shows that the amount of recirculation after the balloon is filled with water (fig. 16) is significantly reduced compared with that before the balloon is filled with water (fig. 15).

The above embodiments are only preferred embodiments of the present invention, and the protection scope of the present invention is not limited thereby, and any insubstantial changes and substitutions made by those skilled in the art based on the present invention are within the protection scope of the present invention.

Claims

1. A catheter assembly for blood diversion, comprising:

the blood vessel guiding device comprises a blood vessel guiding main body for guiding blood, wherein at least one blood guiding hole is formed in the side wall of the upper part of the blood vessel guiding main body;

the blood vessel auxiliary body is used for plugging the introduction of the catheter component, and the blood vessel auxiliary body and the blood vessel main body are arranged in parallel and are not communicated with each other; rubber films cover the top opening and the bottom opening of the blood vessel auxiliary body, and linear incisions are formed in the rubber films.

2. A catheter assembly for blood diversion according to claim 1, said catheter assembly comprising:

the inner cavity of the double-cavity blood guide tube is divided into a blood guide tube main cavity and a blood guide tube side cavity which are mutually isolated, so that the double-cavity blood guide tube forms the blood guide tube main body and the blood guide tube auxiliary body which are not communicated with each other, and the side wall of the upper part of the blood guide tube main body is provided with a plurality of blood guide holes; a side cavity top opening is formed in the top of the blood vessel auxiliary body, a first rubber film covers the side cavity top opening, and a first linear incision is formed in the first rubber film;

the tail end of the blood vessel auxiliary body is connected with the tail end of the blood vessel auxiliary body and communicated with the blood vessel side cavity, a side cavity bottom opening is formed in the tail of the side cavity extension pipe, a second rubber film covers the side cavity bottom opening, and a second linear notch is formed in the second rubber film.

3. The catheter assembly for blood diversion of claim 2, further comprising a buffer extension tube disposed at the trailing end of said dual lumen catheter and in communication with said main lumen of said catheter.

4. The catheter assembly for blood diversion of claim 1, wherein a reinforcing coil is helically disposed on an inner sidewall of said catheter body.

5. A drainage catheter device effective to reduce recirculation, comprising:

the catheter assembly for blood drainage comprises a blood vessel guiding main body and a blood vessel guiding auxiliary body which are arranged in parallel and are not communicated with each other, wherein the side wall of the upper part of the blood vessel guiding main body is provided with at least one blood guiding hole, and the inner side wall of the blood vessel guiding main body is spirally provided with a reinforcing coil;

the catheter component comprises a medium tube main body and an introducing tube main body which are arranged in parallel and are not communicated with each other, wherein the upper part of the medium tube main body is provided with a balloon communicated with the medium tube main body, and the balloon can at least cover one part of a vein opening at the drainage end when being expanded; the catheter component for plugging the venous blood drainage end movably penetrates into the blood vessel auxiliary body, so that the balloon penetrates out of the top of the blood vessel auxiliary body;

the monitoring component is used for monitoring blood pressure, the sensing end of the monitoring component is a blood pressure waveform sensing electrode plate, and the blood pressure waveform sensing electrode plate is arranged on the upper part of the inner wall of the main body of the introducing pipe; the inner wall of the ingress pipe main body extends outwards to be provided with a metal lead, and the metal lead is electrically connected with the blood pressure waveform sensing electrode slice.

6. The drainage catheter device of claim 5, wherein the balloon is a visualization balloon.

7. An in vitro life support system, comprising:

a blood pump and an oxygenator arranged outside the patient body;

the drainage catheter assembly is arranged in a superior vena cava or an inferior vena cava and used for receiving low-oxygenation blood, and comprises a blood vessel main body and a blood vessel auxiliary body which are arranged in parallel and are not communicated with each other, wherein the blood vessel main body is used for blood drainage, and the blood vessel auxiliary body is used for blocking the inlet and outlet of the catheter assembly; at least one blood guide hole is formed in the side wall of the upper part of the blood guide tube main body; rubber films cover the top opening and the bottom opening of the blood vessel auxiliary body, and linear notches are formed in the rubber films; the plugging catheter component is used for preventing oxygenated blood from entering a vein opening at the drainage end;

8. The in vitro life support system of claim 7, wherein said occlusion catheter assembly comprises:

the medium tube comprises a medium tube main body for medium circulation, wherein the upper part of the medium tube main body is provided with a balloon communicated with the medium tube main body, and the balloon can at least cover one part of a drainage end vein opening when being expanded;

the medium pipe is at least used for puncture guide wire input, and the medium pipe body are arranged in parallel and are not communicated with each other;

the monitoring component is used for monitoring blood pressure, and the sensing end of the monitoring component is arranged on the guiding-in pipe main body.

9. An in vitro life support system, comprising:

a blood pump and an oxygenator arranged outside the patient body;

10. An in vitro life support system, comprising:

a blood pump and an oxygenator arranged outside the patient body;