Membrane oxygenator and its manufacturing method

Abstract

This disclosure presents a membrane oxygenator and its manufacturing method. The membrane oxygenator includes: a shell; an oxygenation chamber placed within the shell, with air passages on both sides of the chamber; an oxygenation element located within the oxygenation chamber, with sealing sections at both ends; and two liquid-conducting pipes located between the sealing sections, with liquid-conducting pipes having liquid flow channels communicating with the oxygenation chamber on their sidewalls. This technical solution achieves a uniform blood flow path through the hollow fiber tube's outer surface within the oxygenation chamber via the liquid flow channels. Compared to the blood inlet / outlet design typically used in flat-plate oxygenators, this improves the problem of dead zones that easily form when blood flows towards the corners, thus enhancing the oxygenation effect.

Description

Technical Field

[0001] This disclosure relates to the field of oxygenator technology, specifically to a membrane oxygenator and its manufacturing method. Background Technology

[0002] A membrane oxygenator is a medical device that replaces the lungs when the heart stops beating. It has the function of regulating the oxygen and carbon dioxide content in the blood and is an essential medical device for cardiovascular surgery. The principle of a membrane oxygenator is to oxygenate venous blood drained from the body and remove carbon dioxide in the membrane oxygenator, turning it into arterial blood, and then return it to the patient's body to maintain the supply of oxygenated blood to the body's organs and tissues.

[0003] Existing oxygenators can be categorized by shape into cylindrical and flat-plate oxygenators. In cylindrical oxygenators, blood diffuses from the inner core to the cylindrical outer shell; achieving oxygenation and meeting clinical application requirements necessitates a highly sophisticated structural design. Flat-plate oxygenators, while less demanding in design, have blood flow paths closer to the edges, which can create dead zones and negatively impact oxygenation efficiency. Summary of the Invention

[0004] To address the problems in the related technologies, this disclosure provides a membrane oxygenator and a method for manufacturing it.

[0005] In a first aspect, this disclosure provides a membrane oxygenator.

[0006] Specifically, the membrane oxygenator includes:

[0007] case;

[0008] An oxygenation chamber is placed inside the shell, and air passages are located on both sides of the oxygenation chamber.

[0009] The oxygenation element located in the oxygenation chamber has sealing sections at both ends;

[0010] Two liquid inlet tubes are located between the sealing sections, and the sidewalls of the liquid inlet tubes have liquid flow channels that communicate with the oxygenation chamber.

[0011] Optionally, the liquid flow channel extends from the first end of the liquid passage to the last end of the liquid passage.

[0012] Optionally, the first end of the liquid-passing tube is an inlet or an outlet, and the last end is a closed end;

[0013] The diameter of the tail end of the liquid-passing tube is smaller than that of the head end; preferably, the diameter of the liquid-passing tube gradually decreases from the head end to the tail end.

[0014] Optionally, one side edge of the liquid flow channel contacts the adhesive surface of the sealing section, and the other side edge forms a liquid flow channel with the oxygenation element; preferably, the contact surface forms a continuous smooth curved surface.

[0015] Optionally, the adhesive surface is a sloped adhesive surface, preferably, the slope is selected from 10-80 degrees.

[0016] Optionally, the sloping adhesive surface is formed by centrifugal dispensing.

[0017] Optionally, the housing includes two end caps, which are fixed to both sides of the housing respectively; and / or the end caps are provided with vent pipes; the vent pipes are arranged parallel to the liquid inlet pipes.

[0018] Optionally, the end cap is also provided with a liquid discharge port.

[0019] Optionally, the oxygenation element is woven from oxygenation membrane fabric; or

[0020] The oxygenation element is woven from oxygenation membrane filaments.

[0021] Optionally, the interlayer spacing of the oxygenated membrane filaments may be the same or different.

[0022] Optionally, the oxygenated membrane filaments in the same layer may have the same or different gaps; or, the oxygenated membrane filaments in different layers may have the same or different gaps.

[0023] Secondly, this disclosure provides a method for manufacturing a membrane oxygenator.

[0024] Specifically, the method for manufacturing the membrane oxygenator includes the following steps:

[0025] The oxygenation element is placed inside the housing and fixed. The housing is provided with two liquid passages, and the sidewalls of the two liquid passages each have a liquid flow channel that communicates with the inner cavity of the housing.

[0026] After fixing, the oxygenation element is potted with glue to form a sealing section at both ends of the oxygenation element;

[0027] The cutting and sealing section exposes the end hole of the oxygenation element;

[0028] A membrane oxygenator is obtained by setting end caps at both ends of the oxygenation element.

[0029] Optionally, the process of potting the fixed oxygenation element to form sealing sections at both ends of the oxygenation element includes:

[0030] The fixed oxygenation element is placed into the centrifuge, with the side of the shell with the liquid passage tube closer to the center of the centrifuge.

[0031] An overflow hole is made on the side of the housing opposite to where the liquid inlet pipe is located;

[0032] Turn on the centrifuge to centrifuge and apply glue to both ends of the oxygenation element. Excess glue flows out from the overflow hole into the overflow pool set on the centrifuge, thus forming a sealing section at both ends of the oxygenation element.

[0033] Optionally, it also includes:

[0034] Oxygenating elements are woven from oxygenated membrane fabric or oxygenated membrane fibers.

[0035] Optionally, the oxygenation element woven from oxygenation membrane filament cloth includes:

[0036] The oxygen membrane filament cloth is laid on the support plate of the rectangular woven frame, so that the axis of the hollow fiber tube is perpendicular to the support plate.

[0037] On the drawplate of the rectangular braided frame, fix the nylon thread at the first point, then run it in an S-shape until it is fixed at the second point;

[0038] Another oxygenated membrane fabric is laid on the nylon thread, and the above weaving process is repeated to obtain the oxygenated element.

[0039] Furthermore, the interlayer gap of the oxygen membrane fabric can be adjusted by adjusting the tightness of the S-shaped stitching and / or the compression of the nylon thread on the oxygen membrane fabric.

[0040] Optionally, the oxygenation element woven from oxygenation membrane filaments comprises:

[0041] A layer of oxygen-coated fiber is wound onto the support plate of a rectangular braided frame using a winding machine, so that the axis of the hollow fiber tube is perpendicular to the support plate.

[0042] On the drawplate of the rectangular braided frame, fix the nylon thread at the first point, then run it in an S-shape until it is fixed at the second point;

[0043] Another layer of oxygenated film filament is wound around the support plate, and the above weaving process is repeated to obtain the oxygenated element.

[0044] Furthermore, adjust the spacing of the wound oxygen film filaments; and / or

[0045] Adjust the interlayer gap of the oxygen film filaments by adjusting the tightness of the S-shaped routing and / or the compression of the nylon thread on the oxygen film filaments.

[0046] The technical solutions provided in this disclosure may have the following beneficial effects:

[0047] (1) The membrane oxygenator disclosed herein achieves a uniform blood flow path through the outer surface of the hollow fiber tube in the oxygenation chamber through the liquid flow channel. Compared with the blood inlet and outlet design commonly used in flat oxygenators, it improves the problem of fluid dead zone that is easily formed when blood flows to the corners, thus improving the oxygenation effect.

[0048] (2) In the membrane oxygenator disclosed herein, blood flows from the first end to the last end of the inlet tube. By reducing the diameter of the tube at the last end, the blood flow to the last end is reduced, which can prevent blood from being blocked at the last end, reduce the formation of thrombi, and improve the oxygenation effect.

[0049] (3) The membrane oxygenator disclosed herein can control a portion of the gel solution to enter the liquid inlet tube, forming a gel surface covering one side edge of the liquid flow channel, thereby eliminating potentially harmful eddies that may be generated when blood flows through the edge of the liquid flow channel T. In addition to covering one side edge of the liquid flow channel, the formed gel surface can also have a slope, which on the one hand increases the contact area between blood and oxygen, further improving the oxygenation effect; on the other hand, the downward flow of blood from the liquid flow channel along the gel surface can improve the pressure distribution within the oxygenation chamber area.

[0050] (4) The oxygenation element of the membrane oxygenator disclosed herein can be made of oxygenation membrane fabric. During the weaving process, the interlayer gap of the oxygenation membrane fabric can be adjusted to improve the pressure distribution between different layers, so that the blood flow rate is stable and uniform between the layers, thereby improving the oxygenation effect.

[0051] (5) The membrane oxygenator disclosed herein can be made directly from oxygenation membrane fibers. During the weaving process, the gap between oxygenation membrane fibers in the same layer and the gap between oxygenation membrane fibers in different layers can be adjusted, thereby improving the pressure distribution between different layers from two aspects, so that the blood flow rate is stable and uniform between the layers, thereby improving the oxygenation effect.

[0052] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit this disclosure. Attached Figure Description

[0053] Other features, objects, and advantages of this disclosure will become more apparent from the following detailed description of non-limiting embodiments, taken in conjunction with the accompanying drawings. In the drawings:

[0054] Figure 1 A front view of a membrane oxygenator according to an embodiment of the present disclosure is shown.

[0055] Figure 2 Show Figure 1 A cross-sectional view of plane AA.

[0056] Figure 3 A schematic diagram of an entrance / exit seam according to an embodiment of the present disclosure is shown.

[0057] Figure 4 A schematic diagram of a rectangular braided frame for weaving oxygen-coated membrane fabric is shown.

[0058] Figure 5 This diagram illustrates the routing of wires on a rectangular braided frame.

[0059] Figure 6 A flowchart illustrating a method for manufacturing a membrane oxygenator according to an embodiment of the present disclosure is shown.

[0060] Figure 7a , Figure 7b A schematic diagram illustrating the principle of centrifugal dispensing according to an embodiment of the present disclosure is shown.

[0061] Figure 8 A schematic diagram of a winding machine for winding oxygen film filaments is shown.

[0062] Figure 9 A schematic diagram showing the effect of the inlet / outlet suture edge on the blood flow field is shown.

[0063] Figure 10 A schematic diagram showing the simulation results of the pressure distribution in the oxygenation chamber. Detailed Implementation

[0064] In the following, exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings to enable those skilled in the art to readily implement them. Furthermore, for clarity, portions unrelated to the description of exemplary embodiments have been omitted from the drawings.

[0065] In this disclosure, it should be understood that terms such as “comprising” or “having” are intended to indicate the presence of features, figures, steps, behaviors, components, parts or combinations thereof disclosed in this specification, and are not intended to exclude the possibility of the presence or addition of one or more other features, figures, steps, behaviors, components, parts or combinations thereof.

[0066] It should also be noted that, unless otherwise specified, the embodiments and features described in this disclosure can be combined with each other. This disclosure will now be described in detail with reference to the accompanying drawings and embodiments.

[0067] This disclosure is made to at least partially solve the problems in the prior art that the inventors have discovered.

[0068] Figure 1 A front view of a membrane oxygenator according to an embodiment of the present disclosure is shown. Figure 2 Show Figure 1 A cross-sectional view of plane AA. Figure 3 A schematic diagram of an entrance / exit seam according to an embodiment of the present disclosure is shown.

[0069] like Figure 1 ,2 As shown, the membrane oxygenator 1 is flat and includes a housing 10. The housing 10 includes an upper housing 11, a lower housing 12 and two end caps 13. The upper housing 11 and the lower housing 12 form an opening body. The opening body is a semi-enclosed structure and has openings only on both sides. The two end caps 13 are respectively fixed to one side of the opening body.

[0070] The upper housing 11 is provided with two liquid inlet pipes 21 / 22, which serve as channels for blood flow. Blood flows in from one liquid inlet pipe 21 and flows out from the other liquid inlet pipe 22. In this embodiment, either liquid inlet pipe 21 or 22 can be used as a liquid inlet pipe. In the following embodiments, only liquid inlet pipe 21 is used as an example for illustrative purposes.

[0071] The middle part of the shell 10 is an oxygenation chamber where oxygen and carbon dioxide exchange in the blood takes place. An oxygenation element 40, typically a hollow fiber tube or oxygenation membrane filament, is installed within the oxygenation chamber. Oxygen passes through the inner channel of the hollow fiber tube, while blood passes through its outer surface, resulting in gas exchange between the inner and outer surfaces. The two ends of the hollow fiber tube are filled with adhesive to form a sealing section 41, which serves as a gas-liquid barrier. An air passage 31 / 32 is formed between the sealing section 41 and the two end caps 13. Further, after adhesive filling, the side of the sealing section 41 facing the air passage 31 / 32 is cut to expose the end hole of the hollow fiber tube, thereby connecting the inner channel of the hollow fiber tube with the air passage 31 / 32.

[0072] Two vent pipes 131 / 132 are provided on the end cap 13. Vent pipe 131 connects to airway 31, and vent pipe 132 connects to airway 32. In this embodiment, vent pipes 131 / 132 are arranged parallel to liquid inlet pipes 21 / 22. When liquid inlet pipe 21 is used as a liquid inlet pipe, vent pipe 131 is used as an air inlet pipe, thereby ensuring that the gas flow direction in the oxygenation chamber is the same as the blood flow direction, which is beneficial to gas exchange. It can be understood that when liquid inlet pipe 22 is used as a liquid inlet pipe, vent pipe 132 can be used as an air inlet pipe, which will not be elaborated here.

[0073] The sealing section 41 consists of two parts: the left sealing section 41 isolates the liquid passage 21 from the air passage 31, and the right sealing section 41 isolates the liquid passage 22 from the air passage 32. The sidewalls of the liquid passages 21 / 22 have a liquid flow channel T (refer to...) that communicates with the oxygenation chamber. Figure 3 The system achieves a uniform blood flow path through the hollow fiber tube in the oxygenation chamber via the liquid flow channel T. Compared with the blood inlet and outlet design commonly used in flat oxygenators, this improves the problem of flow dead zones that are easily formed when blood flows to the corners, thus enhancing the oxygenation effect.

[0074] In this disclosed method, the fluid flow channel T can extend from the first end of the fluid inlet tube 21 / 22 to the last end of the fluid inlet tube 21 / 22 to reduce the impact of blood backflow along the tube wall of the fluid inlet tube 21 / 22 to both sides of the oxygenation chamber on the blood flow path, thereby further improving the oxygenation effect.

[0075] Please refer to Figure 3 In this disclosure, the diameter of the tail end of the fluid inlet tube 21 / 22 can be smaller than that of the head end, where the head end is the inlet or outlet and the tail end is a closed end. Considering that the blood flow velocity decreases as it flows towards the tail end, reducing the blood flow to the tail end by decreasing the diameter of the tail end can prevent blood blockage at the tail end, reduce thrombus formation, and improve oxygenation. As a preferred embodiment, the diameter of the fluid inlet tube 21 / 22 can gradually decrease from the head end to the tail end.

[0076] In this disclosed method, one side edge of the fluid flow channel T contacts the adhesive surface of the sealing section 41, and the other side edge forms a fluid flow channel T with the oxygenation element 40, so as to reduce the impact of blood backflow along the pipe wall of the fluid passage 21 / 22 to the sealing section on the blood flow path; preferably, the contact surface forms a continuous smooth curved surface to facilitate blood flow.

[0077] In this disclosed method, during the process of forming the sealing section 41 by pouring glue, a portion of the glue can be controlled to enter the liquid pipe 21 / 22 to form a glue surface covering one side edge of the liquid flow channel T, thereby eliminating the harmful eddies that may be generated when blood flows through the edge of the liquid flow channel T. Figure 9 A schematic diagram showing the effect of the edge of the fluid channel T on the blood flow field is shown. Figure 9 As can be seen from the image, the adhesive surface (right side) formed by this disclosure can eliminate harmful eddies generated at the edges.

[0078] In this disclosed embodiment, the adhesive surface formed on one side edge covering the liquid flow channel T can also have a slope, for example, it can be an adhesive surface at an angle of 10-80° with the lower shell 12, preferably at 45°. On the one hand, this can increase the contact area between blood and oxygen, further improving the oxygenation effect; on the other hand, the blood flowing downwards along the adhesive surface from the liquid flow channel T can improve the pressure distribution within the oxygenation chamber area. Figure 10 A schematic diagram showing the simulation results of the pressure distribution in the oxygenation chamber is provided. Figure 10 As can be seen, the pressure distribution is uniform throughout the region (left figure), there are no dead zones in the flow, the blood flow lines are stable and uniform, and the flow velocity tends to be consistent (right figure).

[0079] In this disclosed method, the sloping adhesive surface can be formed by centrifugal glue pouring, which will be explained in detail later.

[0080] When the membrane oxygenator disclosed herein is in use, the ventilation tube 131 is connected to a gas source, such as an oxygen cylinder. Oxygen enters the inner channel of the hollow fiber tube from the airway 31. The liquid inlet tube 21 / 22 is connected to a drainage tube drawn from the patient. Blood enters from the liquid inlet tube 21 and enters the oxygenation chamber from the liquid flow channel T along the sloped rubber surface. In the oxygenation chamber, the blood exchanges gases with the oxygen entering from the inner channel of the hollow fiber tube. Afterward, the blood flows out from the liquid inlet tube 22 and is guided into the patient's body. The waste gas after the exchange is discharged from the ventilation tube 132.

[0081] In this disclosed method, the end cap 13 is provided with a liquid discharge port 133 for discharging waste liquid flowing into the air passages 31 / 32.

[0082] In this disclosure, the oxygenation element 40 is woven from oxygenation membrane filaments, which can be commercially available and have a warp spacing of 10-12 mm and an average weft spacing of 0.3 mm.

[0083] Figure 4 A schematic diagram of a rectangular braided frame for weaving oxygen-coated membrane fabric is shown. Figure 5 This diagram illustrates the routing of wires on a rectangular braided frame. Please refer to... Figure 4 , Figure 5 The rectangular braided frame is formed by symmetrically arranged support plates a and symmetrically arranged drawer plates b. During weaving, the oxygenated membrane fabric is laid on the support plate a of the rectangular braided frame, so that the axis of the hollow fiber tube is perpendicular to the support plate a. On the drawer plate of the rectangular braided frame, a 20D diameter nylon thread is fixed at point A (for example, with quick-drying adhesive), and then the thread is laid in an S-shape until it is fixed again at point B. It is important to note that the nylon yarn should be taut and close to the oxygenated membrane fabric without gaps, but it should not be tightened towards the oxygenated membrane fabric. Then, the oxygenated membrane fabric is moderately pressed, and a small amount of quick-drying adhesive is applied to the upper and lower outer sides of the drawer plate to fix the nylon yarn and prevent it from slipping. Then, another piece of oxygenated membrane fabric is laid on the nylon thread, and the above weaving process is repeated to obtain the oxygenated element.

[0084] In this disclosed method, the oxygenation element is made of oxygenation membrane fabric woven together. During the weaving process, the interlayer gap of the oxygenation membrane fabric can be adjusted to improve the pressure distribution between different layers, so that the blood flow rate is stable and uniform between the layers, thereby improving the oxygenation effect.

[0085] This disclosure also provides an oxygenation element 40 woven from oxygenation membrane filaments. For details, please refer to... Figure 4 One can evenly wind an oxygenated film filament around two support plates a to form a layer of oxygenated film filament, and then use the above-mentioned nylon thread routing method to weave the oxygenated element layer by layer.

[0086] In this disclosed method, the oxygenation element is directly woven from oxygenation membrane fibers. During weaving, the gap between oxygenation membrane fibers in the same layer and the interlayer gap between oxygenation membrane fibers in different layers can be adjusted, thereby improving the pressure distribution between different layers from two aspects, making the blood flow rate stable and uniform between each layer, so as to improve the oxygenation effect.

[0087] Based on the same or similar design concept, this disclosure also provides a method for manufacturing the above-mentioned membrane oxygenator. Figure 6 A flowchart illustrating a method for manufacturing a membrane oxygenator according to an embodiment of the present disclosure is shown. Figure 6 As shown, the manufacturing method of a membrane oxygenator includes the following steps:

[0088] Step 1: Place the oxygenation element into the housing and fix it in place. The housing is provided with two liquid passages, and the side walls of the two liquid passages each have a liquid flow channel that communicates with the inner cavity of the housing.

[0089] Step 2: Apply adhesive to the fixed oxygenation element to form a sealing section at both ends of the oxygenation element;

[0090] Step 3: Cut the sealing section to expose the end hole of the oxygenation element;

[0091] Step 4: Install end caps at both ends of the oxygenation element to obtain a membrane oxygenator.

[0092] In this disclosed method, step two involves potting adhesive into the fixed oxygenation element to form sealing sections at both ends of the oxygenation element. This includes: placing the fixed oxygenation element into a centrifuge, with the side of the housing with the liquid inlet pipe closer to the center of the centrifuge; opening an overflow hole on the opposite side of the housing with the liquid inlet pipe; turning on the centrifuge to centrifugally pot adhesive into both ends of the oxygenation element, with excess adhesive flowing out from the overflow hole into an overflow pool on the centrifuge, thereby forming sealing sections at both ends of the oxygenation element.

[0093] For example Figures 7a-7b As shown, a centrifuge (not shown) is fixed on a centrifuge turntable 10a. After the oxygenation element is placed into and fixed in the housing 10, the housing 10 is placed into the clamping assembly 10b and fixed on the centrifuge turntable 10a. The clamping assembly 10b is equipped with a clamp 10c. One end of the clamp 10c clamps the glue-filling box 10d (containing glue solution), and the other end clamps an opening on one side of the housing 10. The clamp 10c has a channel connecting the glue-filling box 10d and the housing 10. Under centrifugal force, the glue solution enters the housing 10 through this channel, thus achieving glue filling at one end of the oxygenation element. Then, in the same manner, the other opening of the housing 10 is fixed to the clamp 10c to achieve glue filling at the other end of the oxygenation element.

[0094] It should be noted that the side of the housing 10 with the liquid inlet pipe is closer to the centrifuge center (centrifuge turntable 10a). In order to form a sloped adhesive surface, an overflow hole 10f needs to be opened on the opposite side of the opening body where the liquid inlet pipe is located. The position of the overflow hole 10f is adapted to the position of the overflow pool 10e fixed on the clamping assembly 10b in the figure. Under the action of centrifugal force, the adhesive enters the housing 10 from the glue dispensing box 10d through the channel of the clamp 10c, forming a sloped adhesive surface inside the housing 10. The adhesive surface has a sloping design. Excess adhesive flows out from the overflow hole 10f and into the overflow pool 10e. The position of the overflow hole 10f can be flexibly set. For example, moving the overflow hole 10f upwards raises the adhesive level, while moving it downwards lowers it. The slope of the adhesive surface is adjusted using the overflow hole, thereby controlling the amount of adhesive extending into the fluid passage tube on one side and covering one edge of the fluid flow channel T. Simultaneously, it forms a channel for blood passage with the other edge of the fluid flow channel T. After adhesive filling, the overflow hole is filled with putty to ensure the oxygenation chamber is airtight. The putty is composed of medical epoxy resin mixed with body filler. Since the body filler material may come into contact with blood, it must be biocompatible.

[0095] The method for manufacturing the membrane oxygenator disclosed herein also includes:

[0096] Oxygenating elements are woven from oxygenated membrane fabric or oxygenated membrane fibers.

[0097] Specifically, the oxygenation element is woven from oxygenated membrane fabric as raw material, including: laying the oxygenated membrane fabric on the support plate of a rectangular weaving frame, so that the axis of the hollow fiber tube is perpendicular to the support plate; fixing the nylon thread at the first point on the draw plate of the rectangular weaving frame, and then making an S-shaped threading until fixing at the second point; laying another piece of oxygenated membrane fabric on the nylon thread, and repeating the above weaving process to obtain the oxygenation element.

[0098] Please refer to Figure 4 , Figure 5 The rectangular braided frame is formed by symmetrically arranged support plates a and symmetrically arranged drawer plates b. During weaving, the oxygenated membrane fabric is laid on the support plate a of the rectangular braided frame, so that the axis of the hollow fiber tube is perpendicular to the support plate a. On the drawer plate of the rectangular braided frame, a 20D diameter nylon thread is fixed at point A (for example, with quick-drying adhesive), and then the thread is laid in an S-shape until it is fixed again at point B. It is important to note that the nylon yarn should be taut and close to the oxygenated membrane fabric without gaps, but it should not be tightened towards the oxygenated membrane fabric. Then, the oxygenated membrane fabric is moderately pressed, and a small amount of quick-drying adhesive is applied to the upper and lower outer sides of the drawer plate to fix the nylon yarn and prevent it from slipping. Then, another piece of oxygenated membrane fabric is laid on the nylon thread, and the above weaving process is repeated to obtain the oxygenated element.

[0099] In this disclosed method, before fixing the wire guide plate b inside the shell in step one, the gaps between the comb teeth are filled with putty to prevent blood from leaking through the gaps between the comb teeth when it flows through the oxygenated membrane fabric.

[0100] In this disclosed method, in step one, the support plate a is fixed to the oxygenation element by using the shell. Correspondingly, in step three, when the sealing section is cut to expose the end hole of the oxygenation element, the support plate a, together with part of the shell, is cut to expose the end hole of the oxygenation element.

[0101] The method for manufacturing the membrane oxygenator disclosed herein also includes:

[0102] Adjusting the tightness of the S-shaped threads and / or the compression of the nylon threads on the oxygenation membrane fabric can improve the interlayer spacing of the oxygenation membrane fabric, thereby improving the pressure distribution between different layers and making the blood flow rate stable and uniform between layers to enhance the oxygenation effect.

[0103] In this disclosed method, oxygenated elements are woven from oxygenated membrane filaments, including: using a winding machine to wind a layer of oxygenated membrane filaments onto a support plate of a rectangular woven frame, so that the axis of the hollow fiber tube is perpendicular to the support plate; fixing a nylon thread at a first point on a draw plate of the rectangular woven frame, and then running it in an S-shape on the oxygenated membrane filament fabric until fixing it at a second point; winding another layer of oxygenated membrane filaments onto the support plate, and repeating the above weaving process to obtain the oxygenated element.

[0104] Please refer to Figure 4 An oxygen film filament is evenly wound around two support plates a to form a layer of oxygen film filament. The spacing between adjacent oxygen film filaments can be flexibly adjusted as needed, and this disclosure does not impose any restrictions on this. Then, the following steps are taken... Figure 5 The method of routing the nylon thread involves weaving nylon thread onto the oxygen membrane filament, repeating the process of winding the oxygen membrane filament and weaving the nylon thread layer by layer to obtain the oxygenation element.

[0105] Figure 8 A schematic diagram of a winding machine for winding oxygen film filaments is shown. (For example...) Figure 8 As shown, the main shaft 20a of the winding machine is connected to the wire guide 20c via a belt 20b, so that the wire guide 20c moves synchronously with the winding machine. When the wire guide shaft 20d rotates at a constant speed, the wire guide 20c can move at a constant speed along the axial direction, thereby winding the oxygen film filaments onto the support plate a at equal intervals.

[0106] The method for manufacturing the membrane oxygenator disclosed herein also includes:

[0107] Adjusting the gap between the wound oxygenation membrane fibers and / or adjusting the tightness of the S-shaped threads to adjust the interlayer gap of the oxygenation membrane fibers, and / or adjusting the compression of the nylon threads on the oxygenation membrane fibers to adjust the interlayer gap of the oxygenation membrane fibers, thereby improving the pressure distribution between different layers from two aspects, making the blood flow rate stable and uniform between the layers, so as to improve the oxygenation effect.

[0108] The solution of this application has been described in detail above with reference to the accompanying drawings. For parts not described in detail in this embodiment, please refer to the relevant descriptions of other embodiments, which will not be repeated here.

[0109] The above description is merely a preferred embodiment of this disclosure and an explanation of the technical principles employed. Those skilled in the art should understand that the scope of the invention involved in this disclosure is not limited to technical solutions formed by specific combinations of the above-described technical features, but should also cover other technical solutions formed by arbitrary combinations of the above-described technical features or their equivalents without departing from the inventive concept. For example, technical solutions formed by substituting the above-described features with (but not limited to) technical features disclosed in this disclosure that have similar functions.

Claims

1. A membrane oxygenator, characterized in that, include: case; An oxygenation chamber is placed inside the shell, and air passages are located on both sides of the oxygenation chamber. The oxygenation element located in the oxygenation chamber has a sealing section with sloping adhesive surfaces at both ends; Two liquid-conducting pipes are located between the sealing sections, and the sidewalls of the liquid-conducting pipes have liquid flow channels that communicate with the oxygenation chamber; one side edge of the liquid flow channel contacts the adhesive surface of the sealing section, and the other side edge forms a liquid flow channel with the oxygenation element; Two end caps are fixed to both sides of the housing, respectively.

2. The membrane oxygenator according to claim 1, characterized in that, The liquid flow channel extends from the first end of the liquid passage to the last end of the liquid passage.

3. The membrane oxygenator according to claim 1, characterized in that, The first end of the liquid-passing tube is an inlet or outlet, and the last end is a closed end; The diameter of the tail end of the liquid-passing tube is smaller than that of the head end.

4. The membrane oxygenator according to claim 3, characterized in that, The diameter of the liquid-passing tube gradually decreases from the first end to the last end.

5. The membrane oxygenator according to claim 1, characterized in that, The contact surface that comes into contact with the adhesive surface of the sealing section forms a continuous, smooth curved surface.

6. The membrane oxygenator according to claim 1, characterized in that, The slope is selected from 10-80 degrees.

7. The membrane oxygenator according to claim 6, characterized in that, The sloping adhesive surface is formed by centrifugal glue pouring.

8. The membrane oxygenator according to claim 1, characterized in that, The housing includes: The end cap is provided with a vent pipe; the vent pipe is arranged parallel to the liquid inlet pipe.

9. The membrane oxygenator according to claim 8, characterized in that, The end cap is also provided with a liquid discharge port.

10. The membrane oxygenator according to claim 1, characterized in that, The oxygenation element is woven from oxygenation membrane fabric; or The oxygenation element is woven from oxygenation membrane filaments.

11. The membrane oxygenator according to claim 10, characterized in that, The interlayer spacing of the oxygenated membrane filaments may be the same or different.

12. The membrane oxygenator according to claim 10, characterized in that, The oxygenated membrane filaments in the same layer may have the same or different interlayer spacing; or, the oxygenated membrane filaments in different layers may have the same or different interlayer spacing.

13. A method for manufacturing a membrane oxygenator, characterized in that, Includes the following steps: The oxygenation element is placed inside the housing and fixed. The housing is provided with two liquid passages, and the sidewalls of the two liquid passages each have a liquid flow channel that communicates with the inner cavity of the housing. The fixed oxygenation element is potted with glue to form a sealing section with a sloping glue surface at both ends of the oxygenation element; the glue surface of the sealing section contacts one side edge of the liquid flow channel, and the other side edge forms a liquid flow channel with the oxygenation element. The cutting and sealing section exposes the end hole of the oxygenation element; A membrane oxygenator is obtained by setting end caps at both ends of the oxygenation element.

14. The manufacturing method according to claim 13, characterized in that, The process of potting the fixed oxygenation element with adhesive, forming a sealing section with a sloping adhesive surface at both ends of the oxygenation element, includes: The fixed oxygenation element is placed into the centrifuge, with the side of the shell with the liquid passage tube closer to the center of the centrifuge. An overflow hole is made on the side of the housing opposite to where the liquid inlet pipe is located; Turn on the centrifuge to centrifuge and apply glue to both ends of the oxygenation element. Excess glue flows out from the overflow hole into the overflow pool set on the centrifuge, thus forming a sealing section at both ends of the oxygenation element.

15. The manufacturing method according to claim 13 or 14, characterized in that, Also includes: Oxygenating elements are woven from oxygenated membrane fabric or oxygenated membrane fibers.

16. The manufacturing method according to claim 15, characterized in that, The oxygenation element, woven from oxygenation membrane filament cloth, includes: The oxygenation membrane fabric is laid on the support plate of the rectangular woven frame, so that the axis of the oxygenation element is perpendicular to the support plate. On the drawplate of the rectangular braided frame, fix the nylon thread at the first point, then run it in an S-shape until it is fixed at the second point; Another oxygenated membrane fabric is laid on the nylon thread, and the above weaving process is repeated to obtain the oxygenated element. Adjust the interlayer gap of the oxygen membrane fabric by adjusting the tightness of the S-shaped stitching and / or the compression of the nylon thread on the oxygen membrane fabric.

17. The manufacturing method according to claim 15, characterized in that, The oxygenation element, woven from oxygenation membrane filaments, includes: A layer of oxygen-coated fiber is wound onto the support plate of a rectangular braided frame using a winding machine, so that the axis of the hollow fiber tube is perpendicular to the support plate. On the drawplate of the rectangular braided frame, fix the nylon thread at the first point, then run it in an S-shape until it is fixed at the second point; Another layer of oxygenated film filament is wound around the support plate, and the above weaving process is repeated to obtain the oxygenated element. Adjust the gap between the wound oxygen film filaments; and / or Adjust the interlayer gap of the oxygen film filaments by adjusting the tightness of the S-shaped routing and / or the compression of the nylon thread on the oxygen film filaments.

Images