CN113384764B - Extracorporeal Membrane Oxygenation Cannula Transatrial Septal - Google Patents

Abstract

The invention discloses an extracorporeal membrane pulmonary oxygenation cannula for puncturing atrial septum, which comprises an insertion part, a bending part, a drainage leading-out part and a connecting part which are sequentially connected. The part of the drainage leading-out part close to the bending part is used as a lower vena cava drainage part. The insertion part, the bending part and the inferior vena cava drainage part are provided with openings. The insertion part, the bending part, the drainage guiding-out part and the connecting part comprise an outer layer and an inner layer. Superelastic reinforcing wires are arranged between the outer layer and the inner layer of the insertion part, the bending part and the drainage leading-out part. The outer layer and the inner layer of the insertion part, the bending part, the drainage guide-out part and the connecting part are integrally formed through a liquid plastic-dipping process. The periphery of the openings on the insertion part, the bending part and the inferior vena cava drainage part is provided with a super-elastic strengthening ring. A resettable super-elastic wire is arranged between the outer layer and the inner layer of the bending part. The invention has the advantages of ultra-thin thickness, high mechanical strength, good flexibility, good blood drainage effect, capability of releasing pressure to the left ventricle and the like.

Description

Extracorporeal Membrane Oxygenation Cannula Transatrial Septal

technical field

The invention relates to a medical intubation tube, in particular to an extracorporeal membrane oxygenation (ECMO) intubation tube for piercing the atrial septum.

Background technique

Intubation is an important device for extracorporeal circulation that directly contacts human organs and tissues and realizes the designed function at a specific position. The structure and performance of the cannula largely determine the function and efficiency of the entire blood circulation system.

In recent years, with the development of ECMO systems, whether it is VV-ECMO or VA-ECMO, they have more and more demands for high-efficiency and high-energy intubation. Generally, the wall thickness of the cannula is required to be small, so that under the same outer diameter condition, the thinner the cannula wall, the stronger the blood flow capacity, the smaller the required circulatory driving force, and the less possible damage to the blood. smaller. However, when the wall of the cannula becomes thinner, its mechanical strength and flexibility will decrease, and the mechanical strength and flexibility are the guarantees to ensure that the cannula can smoothly enter the complex structure of the human heart. Moreover, since the inner and outer surfaces of the cannula are in contact with human blood or human tissue, the surface needs to be made of a material with good biocompatibility. However, there is no intubation tube with the above characteristics at the same time.

In addition, taking VA-ECMO as an example, it is easy to cause left ventricular dilatation and pulmonary congestion. However, VA-ECMO itself does not have the function of left ventricular decompression, so the conventional practice is to use additional treatment methods to alleviate the problem of left ventricular pressure. Such as IABP, Impella or surgery to directly reduce blood pressure. However, these treatment methods will bring treatment complexity and additional adverse reactions.

Contents of the invention

The purpose of the present invention is to provide an extracorporeal membrane oxygenation cannula for transatrial septum, which has the characteristics of ultra-thin, high mechanical strength, good flexibility, good blood drainage effect, and can effectively release the left ventricle. Pressure, and in the process of operation, the trauma caused to the patient is minimized, which is suitable for promotion.

In order to achieve the above object, the present invention adopts the following technical solutions:

An extracorporeal membrane oxygenation cannula for transatrial septum, characterized in that it includes a circular tubular insertion part, a curved part, a drainage outlet part and a connecting part connected in sequence, and the part close to the curved part on the drainage outlet part is used as The inferior vena cava drainage part, the insertion part, the bending part and the side wall of the inferior vena cava drainage part are provided with openings, wherein: the insertion part, the bending part, the drainage outlet part and the connection part all include an outer layer and an inner layer; the insertion part , The outer layer of the bending part and the drainage outlet part and the inner layer are provided with a flat superelastic reinforcing wire; the outer layer of the insertion part, the bending part, the drainage outlet part and the connection part is integrally formed by a liquid dipping process, and the insertion part, The inner layer of the bending part, the drainage outlet part and the connecting part is integrally formed by the liquid dipping process; each opening on the insertion part, the bending part and the drainage part of the inferior vena cava is provided with a circle of superelastic reinforcing rings along its outer periphery, and each superelastic The reinforcing ring is connected with the superelastic reinforcing wire adjacent to it; a resettable superelastic wire is arranged between the outer layer and the inner layer of the bending part along the length direction of the bending part, and the resettable superelastic wire is not connected with the superelastic reinforcing wire.

The advantages of the present invention are:

On the one hand, the present invention realizes an ultra-thin foundation with high mechanical strength and good flexibility through the liquid dipping process; Effective pressure relief. On the other hand, the design of the curved part and the repositionable superelastic wire ensures smooth and minimally invasive access to the left ventricle, greatly reducing the trauma to the patient.

Description of drawings

Fig. 1 is a schematic structural view of an extracorporeal membrane oxygenation cannula of the present invention.

Fig. 2 is a partially enlarged schematic view of the front end of the extracorporeal membrane oxygenation catheter of the present invention shown in Fig. 1 .

Fig. 3 is a schematic cross-sectional view of the drainage outlet part.

FIG. 4 is an enlarged schematic view of part A in FIG. 2 .

Fig. 5 is a schematic view illustrating the use of the extracorporeal membrane oxygenation catheter of the present invention.

Detailed ways

As shown in Fig. 1 to Fig. 5, the extracorporeal membrane oxygenation cannula 10 used in the interatrial septum of the present invention comprises a circular tubular insertion part 11, a curved part 12, a drainage outlet part 13 and a connecting part 14 connected in sequence, and the drainage outlet The part near the curved part 12 on the part 13 is used as the inferior vena cava drainage part 16, the side walls of the insertion part 11, the curved part 12 and the inferior vena cava drainage part 16 are provided with openings, and the drainage outlet part 13 removes the inferior vena cava drainage There are no holes on the part of the part 16 and the side wall of the connecting part 14, wherein: the insertion part 11, the bending part 12, the drainage outlet part 13 and the connecting part 14 all include an outer layer 21 and an inner layer 23, the outer layer 21 is outside, and the inside Layer 23 inside; For insertion part 11, bending part 12 and drainage outlet part 13, also be provided with very thin flat superelastic reinforcing wire 22 between their outer layer 21 and inner layer 23 (for clearly showing opening , the insertion part 11 shown in Figure 1, the inferior vena cava drainage part 16 does not show the superelastic reinforcing wire 22); The plastic process is integrally formed, and similarly, the inner layer 23 of the insertion part 11, the bending part 12, the drainage outlet part 13 and the connection part 14 is integrally formed by the liquid dipping process; the insertion part 11, the bending part 12 and the inferior vena cava drainage part 16 Each opening on the top is provided with a circle of superelastic reinforcing ring 24 along its own periphery, and each superelastic reinforcing ring 24 is connected with its adjacent superelastic reinforcing wire 22; A resettable superelastic wire 17 is provided along the length direction of the bending part 12 , and the resettable superelastic wire 17 is not connected with the superelastic reinforcing wire 22 .

In the present invention, the outlet of the insertion part 11 is defined as the front, and the inlet of the connecting part 14 is defined as the rear.

In the actual design, the insertion part 11, the bending part 12, the drainage outlet part 13 and the connection part 14 are all in the form of a circular catheter, the insertion part 11, the drainage outlet part 13 are straight or roughly straight, and the bending part 12 is a circular arc shape, the insertion part 11 and the drainage outlet part 13 are smoothly transitioned through the bending part 12, that is, the insertion part 11, the drainage outlet part 13 and the connecting part 14 are all straight tubes without bending. As shown in Figure 2, the bending part 12 The turning angle is usually an obtuse angle.

FIG. 3 only shows the cross-sectional structure of the drainage outlet part 13. The cross-sectional structures of the insertion part 11 and the curved part 12 are basically the same as the cross-sectional structure of the drainage outlet part 13, so please refer to FIG. 3 for understanding.

As shown in Figure 1, the tube diameters of the insertion part 11, the curved part 12 and the drainage outlet part 13 can be designed to be the same, and the tube diameter of the connecting part 14 is larger than the tube diameter of the drainage outlet part 13. Such a tube diameter design can achieve good blood circulation. flow performance.

In addition, in the actual design, the length of the cannula 10 of the present invention is much longer than that of the common venous cannula, and the lengths of the insertion part 11, the curved part 12 and the drainage part 16 of the inferior vena cava should be reasonably designed according to actual needs, such as according to the patient's heart Parameters are designed and will not be described in detail here.

In actual design, the openings are used for blood dispersion and drainage, and the shape, size, quantity, and arrangement of the openings can be flexibly designed without limitation. Usually, as shown in FIG. 2 , the opening is designed as a circular opening.

In addition, preferably, the openings 151, 152, 153 on the insertion part 11, the bending part 12 and the inferior vena cava drainage part 16 are multiple and evenly distributed, and the number of openings 151 on the insertion part 11 is greater than that of the bending part. 12, the number of openings 152 on the curved part 12 is greater than the number of openings 153 on the inferior vena cava drainage part 16, in other words, the openings 151 on the insertion part 11 are arranged most densely, followed by is the opening 152 on the curved part 12, and the most loosely arranged is the opening 153 on the inferior vena cava drainage part 16, wherein: the cross-sectional area of the opening 151 on the insertion part 11 is smaller than that of the curved part 12 and the lower The cross-sectional areas of the openings 152 , 153 on the vena cava drainage part 16 , and the cross-sectional areas of the opening 152 of the curved part 12 and the opening 153 of the inferior vena cava drainage part 16 can be designed to be equal. Such a design ensures that the blood drainage flow rate of the three parts of the insertion part 11 , the curved part 12 and the inferior vena cava drainage part 16 decreases sequentially, thereby ensuring a good extracorporeal membrane oxygenation cycle effect.

In actual design, although the shape, size and quantity of the openings are not limited, the preferred design is that the cross-sectional area of all the openings on the insertion part 11, the bending part 12 and the inferior vena cava drainage part 16 and should be much larger than the cross-sectional area of the outlet of the insertion part 11. In this way, when the outlet of the insertion part 11 is blocked, the blood can also be introduced into the cannula 10 of the present invention more dispersedly and evenly, thereby avoiding the accumulation of blood in the left ventricle and causing excessive pressure in a certain part.

As shown in FIG. 2 , the resettable superelastic wire 17 is arranged on the convex side of the bending portion 12 , wherein there is one resettable superelastic wire 17 , or multiple resettable superelastic wires 17 are arranged in parallel. Usually two resettable superelastic wires 17 are designed to meet the elastic resettable requirements.

In the present invention, the superelastic reinforcing wires 22 can be arranged continuously in a helical shape (three-dimensional) along the length direction of the cannula 10 of the present invention, and of course other arrangements can also be designed, without limitation.

In the present invention, the superelastic reinforcing wire 22, the superelastic reinforcing ring 24 and the resettable superelastic wire 17 are used to ensure the mechanical strength of the cannula 10 of the present invention, so that the overall force is reliable, and their materials can be designed to be the same.

Furthermore, the superelastic reinforcing wire 22 , the superelastic reinforcing ring 24 and the resettable superelastic wire 17 should be made of metal, preferably made of superelastic nickel-titanium alloy.

In actual production, the superelastic reinforcing ring 24 is connected to the superelastic reinforcing wire 22 by means of electrochemical corrosion or laser processing.

In the present invention, the outer layer 21 and the inner layer 23 are made of a new polymer material with high blood compatibility—organic silicon/polyurethane composite material. In actual design, the outer layer 21 and the inner layer 23 may be translucent or transparent, without limitation.

Before use, punch a hole on the patient's atrial septum 53 by a puncher, and the size of the aperture should be designed according to the diameter of the cannula 10 of the present invention (i.e. the diameter of the insertion part 11, the bending part 12 and the drainage outlet part 13). .

5 to understand that when manipulating and using the cannula 10 of the present invention, a catheter introducer (catheter introducer) is inserted into the cannula 10 of the present invention, so that the insertion part 11, the bending part 12 and the drainage outlet part 13 are linear as a whole ( Or roughly straight) into the inferior vena cava 60 from the femoral vein. When continuing to enter the right ventricle 51, the cannula 10 of the present invention is inserted, and the introducer is gradually withdrawn outward, so that the curved portion 12 can be gradually extended by virtue of the curved structure of the curved portion 12 itself and the shape memory performance of the resettable superelastic wire 17. The bending is restored, so that the insertion part 11 can pass from the right ventricle 51 through the opening on the interatrial septum 53 to enter the left ventricle 52 smoothly. And during this whole insertion process, the cannula 10 of the present invention will not produce great stress on the interatrial septum 53, thereby avoiding unnecessary damage to the left and right ventricles 52, 51 of the heart 50 and other human tissues.

When the insertion part 11 is inserted into the left ventricle 52 and put in place, the introducer is pulled out completely, and the connection part 14 is connected with the relevant extracorporeal blood diversion device, and then blood drainage can be started (as shown by the arrow in FIG. 5 ). At this time, most of the insertion part 11 is in the left ventricle 52, most of the curved part 12 is in the right ventricle 51, and the inferior vena cava drainage part 16 is in the inferior vena cava 60, so the left ventricle 52, right ventricle 51, The blood in the inferior vena cava 60 is designed according to the size and number of openings on the insertion part 11, the curved part 12, and the drainage part 16 of the inferior vena cava, and the blood is drained out to the extracorporeal circulation system in a certain proportion among the three. Thereby effectively avoiding the accumulation of blood in the left ventricle 52 and causing the pressure of the left ventricle to rise, achieving a good extracorporeal membrane oxygenation cycle effect.

The advantages of the present invention are:

1. Compared with the existing single-lumen femoral vein cannula that can only realize femoral vena cava drainage, the present invention realizes the drainage of the inferior femoral vein, right atrium, and left atrium in addition to achieving a good extracorporeal membrane oxygenation cycle effect. The simultaneous drainage of the blood realizes effective pressure relief to the left ventricle, so the present invention can also be called the left ventricle pressure relief femoral vein cannula.

2. In the present invention, the curve design of the curved part and the design of the resettable superelastic wire make the curvature of the cannula of the present invention controllable in the process of entering the left ventricle from the inferior femoral vein and right ventricle, ensuring the The cannula of the present invention can pass through the interatrial septum without twisting force. Specifically, with the assistance of the introducer, after entering the right ventricle from the inferior vena cava in a straight line (or roughly in a straight line), the cannula of the present invention The tube can be gradually bent to pass smoothly from the right ventricle through the opening in the atrial septum and into the left ventricle without exerting great stress on the opening in the atrial septum and avoiding stress during the upward insertion into the heart. Damage to the right ventricle, as well as avoiding unnecessary damage to human tissue within the heart.

3. In the present invention, the insertion part is used to insert into the left atrium, and the small diameter and large density of the holes on the insertion part are evenly distributed, so that the blood flow in the left atrium can be controlled by controlling the depth of the insertion part inserted into the left atrium. Effective control, and then to achieve effective control of left ventricular pressure, to avoid left ventricular pressure increase.

4. The outer layer and inner layer of the present invention are made of organic silicon/polyurethane composite material, which has high blood compatibility, greatly improves safety on the basis of ensuring mechanical strength and flexibility, and meets the requirements of extracorporeal circulation of blood. Moreover, the outer layer and the inner layer of the cannula of the present invention are integrally formed by a liquid dipping process, which simplifies the difficulty of making the cannula. Although the liquid dipping process (also known as a solution casting process) is a well-known polymer material forming technology , but the present invention applies it to the making of medical intubation for the first time.

5. The superelastic reinforcing wire, superelastic reinforcing ring and resettable superelastic wire of the present invention are made of nickel-titanium alloy material, which has superelasticity (10 times superelasticity compared to stainless steel), and relatively low hardness It can be made ultra-thin, it has both mechanical strength and stability, and also has super anti-torque, low density, non-magnetic, good overall mechanical properties and super anti-deformation ability, and also has good blood compatibility.

6. The present invention adopts the superelastic reinforcing ring made of nickel-titanium alloy to strengthen the firmness of the opening, increases the mechanical strength without losing the flexibility, and ensures the drainage effect.

The above are the preferred embodiments of the present invention and the technical principles used therein. For those skilled in the art, without departing from the spirit and scope of the present invention, any technical solution based on the present invention, etc. Obvious changes such as effective conversion and simple replacement all fall within the protection scope of the present invention.

Claims (5)

1. A kind of extracorporeal membrane oxygenation intubation that is used to pass through the interatrial septum, is characterized in that: it comprises the circular tubular insertion part that is connected successively, bending part, drainage outlet part and connecting part, on the drainage outlet part near the bending part Part of it serves as the inferior vena cava drainage part, and openings are provided on the side walls of the insertion part, the bending part and the inferior vena cava drainage part, wherein: the insertion part, the bending part, the drainage outlet part and the connection part all include an outer layer and an inner layer; There is a flat superelastic reinforcing wire between the outer layer and the inner layer of the insertion part, the bending part and the drainage outlet part; The inner layer of the inner part, the bending part, the drainage outlet part and the connection part are integrally formed by the liquid dipping process; the openings on the insertion part, the bending part and the drainage part of the inferior vena cava are provided with a circle of superelastic reinforcement rings along their outer circumference, each The superelastic reinforcing ring is connected with the superelastic reinforcing wire adjacent to it; a resettable superelastic wire is arranged between the outer layer and the inner layer of the bending part along the length direction of the bending part, and multiple resettable superelastic wires are arranged in parallel and can be reset The superelastic wire is not connected with the superelastic reinforcing wire, and the resettable superelastic wire is arranged on the convex side of the bending part; with the help of the curved structure of the bending part itself and the shape memory performance of the resettable superelastic wire, the overall linear insertion part , the curved part and the drainage outlet part gradually recover the curved part as the introducer is gradually drawn out, wherein, when manipulating and using the extracorporeal membrane oxygenation catheter for transcardiac septum, the introducer is inserted into the In the extracorporeal membrane oxygenation catheter through the interatrial septum; the openings on the insertion part, bending part and inferior vena cava drainage part are multiple and evenly distributed, and the number of openings on the insertion part is larger than that on the bending part Quantity, the number of openings on the curvature is greater than the number of openings on the inferior vena cava drainage, the cross-sectional area of the openings on the insertion portion is smaller than the cross-sectional area of the openings on the curvature and the inferior vena cava drainage, insertion The sum of the cross-sectional areas of the openings on the part, the curved part and the drainage part of the inferior vena cava is much larger than the cross-sectional area of the outlet of the insertion part. 2. The extracorporeal membrane oxygenation catheter for passing through the interatrial septum as claimed in claim 1, characterized in that: The materials of the superelastic reinforcing wire, the superelastic reinforcing ring and the resettable superelastic wire are the same. 3. The extracorporeal membrane oxygenation catheter for passing through the interatrial septum as claimed in claim 1 or 2, characterized in that: The superelastic reinforcing wire, the superelastic reinforcing ring and the resettable superelastic wire are made of nickel-titanium alloy. 4. The extracorporeal membrane oxygenation catheter for passing through the interatrial septum as claimed in claim 3, characterized in that: The superelastic reinforcing ring is connected with the superelastic reinforcing wire by electrochemical corrosion method or laser processing method. 5. The extracorporeal membrane oxygenation catheter for passing through the interatrial septum as claimed in claim 1 or 2, characterized in that: The outer layer and the inner layer are made of silicone/polyurethane composite material.

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