Spiral flow guide integrated membrane oxygenator

Abstract

The application relates to a spiral guide integrated membrane oxygenator, which comprises a lower cover with an air outlet pipe, an oxygenation part including a mandrel structure, an oxygenation shell and an oxygenation wire membrane structure, the oxygenation shell being provided with a blood outlet pipe, and an upper cover provided with a blood inlet pipe and an oxygen inlet pipe, the oxygen inlet pipe and the air outlet pipe being communicated with the space between the mandrel structure and the oxygenation shell; wherein the mandrel structure comprises a mandrel body and an annular guide plate, a blood passage is arranged between the first end and the upper cover, the annular guide plate is provided with a plurality of guide holes, and the plurality of guide holes of the annular guide plate are distributed on the annular guide plate; the oxygenation wire membrane structure comprises a plurality of hollow fiber layers, each hollow fiber layer is provided with a plurality of hollow fiber pipes, the plurality of hollow fiber pipes are inclined at an angle relative to a vertical plane, and the inclined directions of the plurality of hollow fiber pipes of each hollow fiber layer are different from and cross the inclined directions of the plurality of hollow fiber pipes of adjacent hollow fiber layers. In this way, the utilization rate of the wire membrane structure and the oxygenation efficiency can be improved.

Description

[0001] This application is a divisional application of application number 201710817792.5, filed on September 12, 2017, entitled "A Spiral Flow Integrated Membrane Oxygenator". Technical Field

[0002] This application relates to the technical field of medical device products, and more particularly to a spiral flow integrated membrane oxygenator. Background Technology

[0003] A membrane oxygenator is a medical device that replaces the lungs during cardiac arrest. It regulates the oxygen and carbon dioxide levels in the blood and is an essential medical device for cardiovascular surgery, as well as for treating acute respiratory illnesses and awaiting lung transplantation. The principle of a membrane oxygenator is to draw venous blood from the body, pass it through the membrane oxygenator for oxygen and carbon dioxide exchange, transforming it into arterial blood, which is then returned to the patient's arterial system. This maintains the oxygenated blood supply to the body's organs and tissues, temporarily replacing the function of the lungs during surgery. It also provides surgeons with a quiet, bloodless, and clear surgical environment to facilitate the procedure.

[0004] However, the utilization rate of the membrane structure in current membrane oxygenators is not high, mainly because its blood diversion and diffusion efficiency is poor. Blood tends to accumulate in a certain place in the membrane oxygenator and only flows through that one part of the membrane structure, without flowing through other parts of the membrane structure. Summary of the Invention

[0005] Therefore, it is necessary to address the problem of low utilization rate of current silk membrane structures by providing a spiral flow integrated membrane oxygenator that can improve the utilization rate of silk membrane structures and ensure the efficiency of blood flow diffusion.

[0006] A spiral-guided integrated membrane oxygenator includes:

[0007] The lower cover has an air vent.

[0008] An oxygenation section, disposed above the lower cover, includes a mandrel structure, an oxygenation shell, and an oxygenation filament membrane structure disposed between the mandrel structure and the oxygenation shell. The oxygenation shell has an outlet vessel, which is located near the lower cover.

[0009] The upper cover is located below the oxygenation section and is opposite to the lower cover. The upper cover has an inlet tube and an oxygen inlet tube. The oxygen inlet tube and the outlet tube connect the space between the spindle structure and the oxygenation shell.

[0010] The mandrel structure includes a mandrel body and an annular guide plate. The mandrel body has a first end and a second end connected to the first end. A blood channel is provided between the first end and the upper cover. The annular guide plate is sleeved on the mandrel body and has multiple flow guiding holes distributed on the annular guide plate.

[0011] The oxygenated fiber membrane structure includes multiple hollow fiber layers. Each hollow fiber layer has multiple hollow fiber tubes. The multiple hollow fiber tubes are tilted at an angle relative to the vertical plane. The tilting direction of the multiple hollow fiber tubes in each hollow fiber layer is different from the tilting direction of the multiple hollow fiber tubes in the adjacent hollow fiber layers and they intersect each other.

[0012] In one embodiment of this application, the hollow fiber tube of each hollow fiber layer forms an angle of 15 degrees with the vertical plane.

[0013] In one embodiment of this application, each of the flow-guiding perforations of the annular guide plate is a tapered hole, and the diameter of the flow-guiding perforation located on the inner side of the annular guide plate is smaller than the diameter of the flow-guiding perforation located on the outer side of the annular guide plate.

[0014] In one embodiment of this application, the plurality of flow guiding holes of the annular guide plate include at least one first flow guiding hole and at least one second flow guiding hole. The at least one first flow guiding hole of the annular guide plate is close to the lower cover, and the at least one second flow guiding hole of the annular guide plate is located above the at least one first flow guiding hole of the annular guide plate and close to the upper cover. The diameter of the at least one second flow guiding hole of the annular guide plate is larger than the diameter of the at least one first flow guiding hole of the annular guide plate.

[0015] In one embodiment of this application, the inner surface of the annular guide plate has a plurality of spiral guide grooves spaced apart, and a plurality of guide perforations are located between the plurality of spiral guide grooves, with each spiral guide groove surrounding more than half a circle around the inner surface of the annular guide plate.

[0016] In one embodiment of this application, the horizontal circumferential length from one end to the other end of each spiral guide groove is greater than the semicircular circumference of the annular guide plate, and the vertical distance from one end to the other end of each spiral guide groove is between one-half and two-thirds of the height of the annular guide plate.

[0017] In one embodiment of this application, the spiral-guided integrated membrane oxygenator further includes an annular partition, which is disposed between the mandrel structure and the oxygenation shell. The annular partition also has a flow-guiding structure for guiding blood diffusion. The lower cover has a water inlet pipe, and the upper cover has a water outlet pipe. The water inlet pipe and the water outlet pipe connect the space between the annular partition and the mandrel structure. The oxygen inlet pipe and the air outlet pipe connect the space between the annular partition and the oxygenation shell. A temperature-changing membrane structure is provided between the annular partition and the mandrel structure, and the oxygenation membrane structure is also provided between the annular partition and the oxygenation shell. The temperature-changing membrane structure has the same structure as the oxygenation membrane structure.

[0018] In one embodiment of this application, the annular partition has a plurality of blood inlets arranged in a ring as a flow guiding structure, and the plurality of blood inlets are close to the lower cover.

[0019] In one embodiment of this application, the outer surface of the annular partition is provided with a plurality of spiral guide grooves as a flow guiding structure, and the spiral guide grooves are located on one side of the plurality of blood inlets of the annular partition.

[0020] In one embodiment of this application, one end of each of the spiral guide grooves is connected to the corresponding blood inlet.

[0021] In one embodiment of this application, the annular partition has at least one flow-guiding perforation as a flow-guiding structure, and the flow-guiding perforation is distributed on the corresponding annular partition.

[0022] In one embodiment of this application, the spiral flow-guided integrated membrane oxygenator further includes a middle annular partition and an outer annular partition. The outer annular partition is disposed outside the middle annular partition and adjacent to the oxygenation shell. The diameter of the middle annular partition is smaller than the diameter of the outer annular partition. The middle annular partition and the outer annular partition each have a plurality of blood inlets arranged in a ring as a flow-guiding structure. The positions of the plurality of blood inlets of the middle annular partition are opposite to the positions of the plurality of blood inlets of the outer annular partition.

[0023] In one embodiment of this application, the spiral flow-guided integrated membrane oxygenator further includes a middle annular partition and an outer annular partition. The outer annular partition is disposed outside the middle annular partition and adjacent to the oxygenation shell. The middle annular partition and the outer annular partition each have a plurality of flow-guided perforations as flow-guided structures. The aperture of the plurality of flow-guided perforations in the middle annular partition is larger than the aperture of the plurality of flow-guided perforations in the annular flow-guided plate of the mandrel structure. The aperture of the plurality of flow-guided perforations in the outer annular partition is smaller than the aperture of the plurality of flow-guided perforations in the middle annular partition.

[0024] In one embodiment of this application, the aperture of the plurality of flow-guiding perforations of the middle annular partition and the outer annular partition, and the plurality of flow-guiding perforations of the annular guide plate is greater than 3 mm, and the shortest distance between the center of the flow-guiding perforation of the outer annular partition adjacent to the outlet blood vessel and the center of the outlet blood vessel is greater than 5 mm.

[0025] In one embodiment of this application, the inner surfaces of the middle annular partition and the outer annular partition are further provided with a plurality of spaced spiral guide grooves as a flow guiding structure, and the plurality of flow guiding holes of the middle annular partition and the outer annular partition are respectively located in the plurality of spiral guide grooves of the middle annular partition and the outer annular partition.

[0026] In one embodiment of this application, the horizontal circumferential length from one end to the other end of each spiral guide groove is greater than the semicircular circumference of the middle annular partition or the outer annular partition, and the vertical distance from one end to the other end of each spiral guide groove is between one-half and two-thirds of the height of the middle annular partition or the outer annular partition.

[0027] In one embodiment of this application, the oxygenation section further includes an upper barrier structure and a lower barrier structure. The lower barrier structure passes through the mandrel structure and covers the lower cover, while the upper barrier structure passes through the mandrel structure and is disposed below the upper cover. The two are disposed opposite to each other and are both located between the mandrel structure and the oxygenation shell.

[0028] The mandrel structure of this application features an annular guide plate. This guide plate, through a perforated flow-guiding structure, directs blood flow and diverts the blood, increasing the diffusion area and contact area between the blood and the membrane structure. This effectively improves the utilization rate of the membrane structure and enhances the oxygenation efficiency of the membrane oxygenator. Simultaneously, the hollow fiber tubes in each hollow fiber layer reduce the amount of blood pre-filled. When blood flows between adjacent hollow fiber layers of the membrane structure, it is diverted into a thinner blood film, increasing the contact area between the blood and oxygen and improving the oxygenation efficiency. Attached Figure Description

[0029] Figure 1 This is a perspective view of the spiral flow integrated membrane oxygenator according to the first embodiment of this application.

[0030] Figure 2 This is an assembly diagram of the spiral flow integrated membrane oxygenator according to the first embodiment of this application.

[0031] Figure 3 This is a cross-sectional view of the spiral flow integrated membrane oxygenator according to the first embodiment of this application.

[0032] Figure 4This is an assembly diagram of the spiral flow integrated membrane oxygenator according to the second embodiment of this application.

[0033] Figure 5 This is a cross-sectional view of the spiral flow integrated membrane oxygenator according to the second embodiment of this application.

[0034] Figure 6 This is a schematic diagram of the mandrel structure according to the third embodiment of this application.

[0035] Figure 7 This is a schematic diagram of the annular partition according to the fourth embodiment of this application.

[0036] Figure 8 This is a cross-sectional view of the spiral flow integrated membrane oxygenator according to the fifth embodiment of this application.

[0037] Figure 9 This is a schematic diagram of the annular partition in the sixth embodiment of this application.

[0038] Figure 10 This is a schematic diagram of the outer annular partition of the sixth embodiment of this application.

[0039] Figure 11 This is a cross-sectional view of the mandrel structure according to the seventh embodiment of this application.

[0040] Figure 12 This is a schematic diagram of the silk film structure according to the eighth embodiment of this application. Detailed Implementation

[0041] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0042] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0043] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0044] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0045] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0046] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0047] Please see Figure 1 , Figure 2 and Figure 3This is a perspective view, assembly view, and cross-sectional view of the spiral flow integrated membrane oxygenator 1 according to the first embodiment of this application. As shown in the figure, this embodiment provides a spiral flow integrated membrane oxygenator 1, which includes a lower cover 10, an oxygenation part 11, and an upper cover 12. The oxygenation part 11 is disposed between the lower cover 10 and the upper cover 12. The lower cover 10 includes a lower cover housing 101, a first lower annular support piece 102a, a second lower annular support piece 102b, an air outlet pipe 103, and a water inlet pipe 104. The lower cover housing 101 has a lower surface 1011 and a lower annular sidewall 1012 surrounding the lower surface 1011. A first lower annular support piece 102a and a second lower annular support piece 102b are disposed on the lower surface 1011 of the lower cover housing 101. The second lower annular support piece 102b is located outside the first lower annular support piece 102a and inside the lower annular sidewall 1012. The diameter of the first lower annular support piece 102a is smaller than the diameter of the second lower annular support piece 102b. The centers of the first lower annular support piece 102a and the second lower annular support piece 102b are on the same line as the center of the lower cover 10, that is, the first lower annular support piece 102a and the second lower annular support piece 102b are arranged in concentric circles inside the lower cover housing 101. An air outlet pipe 103 is disposed on the lower surface 1011 of the lower cover housing 101 and communicates with the space between the second lower annular support piece 102b and the lower annular sidewall 1012. The water inlet pipe 104 is disposed on the lower annular sidewall 1012 and passes through the lower annular sidewall 1012 and the second lower annular support piece 102b. The water inlet pipe 104 connects the space between the second lower annular support piece 102b and the first lower annular support piece 102a.

[0048] The oxygenation section 11 includes a mandrel structure 110, an annular partition 111, an oxygenation shell 112, a lower barrier structure 113, a temperature-changing membrane structure 114, an oxygenation membrane structure 115, and an upper barrier structure 116. The mandrel structure 110 is disposed on and within the first lower annular support plate 102a. The annular partition 111 is disposed on the second lower annular support plate 102b and is located outside the mandrel structure 110. The oxygenation shell 112 is disposed on the lower annular sidewall 1012 of the lower cover shell 101 and has an outlet vessel 1121 and a circulation exhaust pipe 1122. The outlet vessel 1121 is close to the lower cover 10, and the circulation exhaust pipe 1122 is located above the outlet vessel 1121 and away from the lower cover 10. The outlet vessel 1121 and the circulation exhaust pipe 1122 connect the space between the mandrel structure 110 and the oxygenation shell 112. The lower barrier structure 113 passes through the mandrel structure 110 and covers the lower cover 10, and is located between the mandrel structure 110 and the oxygenation shell 112. The variable-temperature filament membrane structure 114 passes through the mandrel structure 110 and is disposed on the lower barrier structure 113, and is located between the mandrel structure 110 and the annular partition 111, thus forming a variable-temperature zone between the mandrel structure 110 and the annular partition 111. The oxygenation filament membrane structure 115 passes through the mandrel structure 110 and is disposed on the lower barrier structure 113, and is located between the annular partition 111 and the oxygenation shell 112, thus forming an oxygenation zone between the annular partition 111 and the oxygenation shell 112. The upper barrier structure 116 passes through the mandrel structure 110 and is disposed on the variable-temperature filament membrane structure 114 and the oxygenation filament membrane structure 115, and is located between the mandrel structure 110 and the oxygenation shell 112.

[0049] The mandrel structure 110 of this embodiment includes a mandrel body 1101 and an annular guide plate 1102. The mandrel body 1101 has a first end 1101a and a second end 1101b connected to the first end 1101a. The outer diameter of the second end 1101b is larger than the outer diameter of the first end 1101a, and the second end 1101b is disposed within a first lower annular support plate 102a. The annular guide plate 1102 passes through the mandrel body 1101 and is disposed on the first lower annular support plate 102a of the lower cover 10. The annular guide plate 1102 has a plurality of flow guiding holes 11021, which are evenly distributed on the annular guide plate 1102. In this embodiment, each flow guiding hole 11021 is a tapered hole, and the diameter of the flow guiding hole 11021 located on the inner side of the annular guide plate 1102 is smaller than the diameter of the flow guiding hole 11021 located on the outer side of the annular guide plate 1102. Of course, the flow guiding perforation 11021 in this embodiment can also be a straight hole, which will not be elaborated here.

[0050] The annular partition 111 of this embodiment has multiple blood inlets 1111 arranged in a ring. These multiple blood inlets 1111 serve as a flow guiding structure and are located near the lower cover 10. The annular partition 111 of this embodiment primarily provides support and extends the blood diffusion path, increasing the contact area and diffusion area between the blood and the temperature-controlled filament membrane structure 114 and the oxygenated filament membrane structure 115, thereby improving the utilization rate of the temperature-controlled filament membrane structure 114 and the oxygenated filament membrane structure 115.

[0051] The upper cover 12 includes an upper cover shell 121, a first upper annular support piece 122a, a second upper annular support piece 122b, an inlet tube 124, an oxygen inlet tube 125, and an outlet tube 126. The upper cover shell 121 has an upper surface 1211 and an upper annular sidewall 1212 surrounding the upper surface 1211. The first upper annular support piece 122a and the second upper annular support piece 122b are disposed on the upper surface 1211 of the upper cover shell 121. The second upper annular support piece 122b is located outside the first upper annular support piece 122a. The first upper annular support piece 122a and the second upper annular support piece 122b are located inside the upper annular sidewall 1212. The centers of the first upper annular support piece 122a and the second upper annular support piece 122b are on the same line as the center of the upper cover shell 121. An inlet tube 124 is disposed on the upper annular sidewall 1212 of the upper cover housing 121, and passes through the upper annular sidewall 1212, the second upper annular support piece 122b, and the first upper annular support piece 122a, and communicates with the space within the first upper annular support piece 122a. An oxygen inlet tube 125 is disposed on the upper annular sidewall 1212 of the upper cover housing 121, and passes through the upper annular sidewall 1212, and communicates with the space between the upper annular sidewall 1212 and the second upper annular support piece 122b. A water outlet tube 126 is disposed on the upper annular sidewall 1212 of the upper cover housing 121, and passes through the upper annular sidewall 1212 and the second upper annular support piece 122b, and communicates with the space between the first upper annular support piece 122a and the second upper annular support piece 122b.

[0052] When the upper cover 12 is disposed on the oxygenation section 11, the first upper annular support piece 122a and the second upper annular support piece 122b are arranged concentrically within the upper cover housing 121. The first lower annular support piece 102a corresponds to the first upper annular support piece 122a, and the second lower annular support piece 102b corresponds to the second upper annular support piece 122b. The upper annular sidewall 1212 of the upper cover housing 121 corresponds to the lower annular sidewall 1012 of the lower cover housing 101. The upper annular sidewall 1212 of the upper cover housing 121, the second upper annular support piece 122b, and the first upper annular support piece 122a are respectively engaged with the oxygenation housing 112, the annular partition 111, and the annular guide plate 1102 of the spindle structure 110 of the oxygenation section 11. The centers of the lower cover 10, the oxygenation section 11, and the upper cover 12 are located on the same line. The outer diameter of the first end 1101a of the spindle body 1101 is smaller than the outer diameter of its second end 1101b, so that a blood passage is formed between the first end 1101a of the spindle body 1101 and the annular guide plate 1102 to flow out of the spindle structure 110, and the blood passage is connected to the upper cover 12.

[0053] The space between the first lower annular support piece 102a and the second lower annular support piece 102b of the lower cover housing 101 and the space between the first upper annular support piece 122a and the second upper annular support piece 122b of the upper cover housing 121 correspond to the space between the mandrel structure 110 and the annular partition 111. The water inlet pipe 104 of the lower cover 10 and the water outlet pipe 126 of the upper cover 12 connect the space between the mandrel structure 110 and the annular partition 111. The space between the lower annular sidewall 1012 of the lower cover housing 101 and the second lower annular support piece 102b and the space between the upper annular sidewall 1212 of the upper cover housing 121 and the second upper annular support piece 122b correspond to the space between the mandrel structure 110 and the oxygenation housing 112. The oxygen inlet pipe 125 of the upper cover 12 and the air outlet pipe 103 of the lower cover 10 connect the space between the mandrel structure 110 and the oxygenation housing 112.

[0054] In this embodiment, when the spiral-guided integrated membrane oxygenator 1 is in use, blood from the extracorporeal blood circuit device enters the blood channel of the spindle body 1101 through the inlet blood vessel 124. When the blood enters the blood channel, it flows from top to bottom along the outer surface of the spindle body 1101. Then, blood flows from the multiple flow-guiding perforations 11021 of the annular guide plate 1102 to the temperature-controlled membrane structure 114. The multiple flow-guiding perforations 11021 divert the blood flow, reducing the blood flow rate and velocity within a single flow-guiding perforation 11021. The blood flowing out from each flow-guiding perforation 11021 can gently contact the temperature-controlled membrane structure 114. In addition, radial flow is achieved through the multiple flow-guiding perforations 11021, increasing the contact area and diffusion area between the blood and the temperature-controlled membrane structure 114, improving the utilization rate of the temperature-controlled membrane structure 114, and reducing the pressure of the spiral flow-guiding integrated membrane oxygenator 1. In other words, the annular guide plate 1102 of this embodiment has a flow-guiding structure composed of multiple flow-guiding perforations 11021 to achieve the above-mentioned effects.

[0055] When blood enters the temperature-regulating membrane structure 114, simultaneously, temperature-regulating water enters through the inlet pipe 104 of the lower cover 10. The temperature-regulating water flows from one end of the temperature-regulating membrane structure 114 near the lower cover 10 to the other end near the upper cover 10, thus adjusting the temperature of the blood diffused into the temperature-regulating membrane structure 114. The blood that has diffused into the temperature-regulating membrane structure 114 and had its temperature adjusted flows back to the lower cover 10 and then flows in through the multiple blood inlets 1111 of the annular partition 111, diffusing towards the oxygenation membrane structure 115.

[0056] When blood flows into the oxygenation membrane structure 115, oxygen is introduced from the oxygen inlet tube 125 into the space between the second upper annular support plate 122b and the oxygenation shell 112. In other words, the oxygen in the oxygen inlet tube 125 oxygenates the blood in the oxygenation membrane structure 115, replacing the carbon dioxide in the blood. Carbon dioxide is generated during the oxygenation process, sinks to the lower cover 10, and is discharged through the vent tube 103 of the lower cover 10. Finally, the oxygenated blood is discharged from the outlet tube 1121 of the oxygenation shell 112.

[0057] The aforementioned temperature-controlled filament membrane structure 114 and oxygenated filament membrane structure 115 each comprise multiple layers of hollow fiber. The cross-section of the hollow fiber tube in each layer is circular, square, or elliptical. When a hollow fiber in each layer ruptures, the resulting gas is discharged through the circulation exhaust pipe 1122 of the oxygenated shell 112. The lower barrier structure 113 and the upper barrier structure 116 prevent blood located within the temperature-controlled filament membrane structure 114 and the oxygenated filament membrane structure 115 from moving towards the lower cover 10 or the upper cover 12.

[0058] Please see Figure 4 and Figure 5This is an assembly diagram and cross-sectional view of the spiral flow integrated membrane oxygenator 1 according to the second embodiment of this application. As shown in the figure, the spiral flow integrated membrane oxygenator 1 of this embodiment differs from the spiral flow integrated membrane oxygenator of the above embodiment in that the spiral flow integrated membrane oxygenator 1 of this embodiment omits the setting of the temperature-changing zone, that is, it omits the water inlet pipe of the lower cover 10, the second lower annular support plate of the lower cover 10, the annular partition, the second upper annular support plate of the upper cover 12, and the water outlet pipe of the upper cover 12. The oxygenation membrane structure 115 is directly disposed between the core shaft structure 110 and the oxygenation shell 112. The air outlet pipe 103 of the lower cover 10 and the oxygen inlet pipe 125 of the upper cover 12 are respectively connected to the space between the core shaft structure 110 and the oxygenation shell 112, thus forming an oxygenation zone in the space between the core shaft structure 110 and the oxygenation shell 112.

[0059] Please see Figure 6 Figure 10 is a schematic diagram of the mandrel structure 110 according to the third embodiment of this application. As shown in the figure, the flow guiding structure of the annular guide plate 1102 of the mandrel structure 110 of this embodiment includes a plurality of first flow guiding holes 11021a and a plurality of second flow guiding holes 11021b. The plurality of first flow guiding holes 11021a are close to the lower cover 10, that is, they are distributed below the annular guide plate 1102. The plurality of second flow guiding holes 11021b are distributed above the annular guide plate 1102, that is, they are located above the plurality of first flow guiding holes 11021a and close to the upper cover 12. The aperture of the plurality of second flow guiding holes 11021b is larger than the aperture of the plurality of first flow guiding holes 11021a.

[0060] Please see Figure 7This is a schematic diagram of the annular partition 111 according to the fourth embodiment of this application. As shown in the figure, following the first embodiment, the outer surface of the annular partition 111 in this embodiment has a flow guiding structure, which is a plurality of spiral flow guiding grooves 1112 spaced apart. The plurality of spiral flow guiding grooves 1112 of the annular partition 111 are located on one side of the plurality of blood inlets 1111 of the annular partition 111, and even one end of each spiral flow guiding groove 1112 is connected to the corresponding blood inlet 1111. The horizontal circumference length of one end and the other end of each spiral flow guiding groove 1112 is greater than the semicircular circumference of the annular partition 111. In other words, each spiral flow guiding groove 1112 surrounds more than half a circle of the annular partition 111. The vertical distance between the two ends of each spiral flow guiding groove 1112 is between one-half the height of the annular partition 111 and two-thirds of the height of the annular partition 111. The annular baffle 111 has multiple spiral guide grooves 1112 that guide blood flow and diffuse to fill the multiple spiral guide grooves 1112, increasing the diffusion area of ​​the blood to ensure full contact with the oxygenated filament membrane structure, thereby increasing the contact area and utilization rate between the oxygenated filament membrane structure and the blood. Each spiral guide groove 1112 has one end connected to a corresponding blood inlet 1111, allowing blood to flow from multiple blood inlets 1111 and immediately into multiple spiral guide grooves 1112, rapidly filling the entire spiral guide groove 1112.

[0061] Please see Figure 8This is a cross-sectional view of the spiral flow integrated membrane oxygenator 1 according to the fifth embodiment of this application. As shown in the figure, the number of annular partitions in this embodiment is two, referred to as the middle annular partition 111a and the outer annular partition 111b. The diameter of the middle annular partition 111a is smaller than the diameter of the outer annular partition 111b. The middle annular partition 111a is fixed by the corresponding second lower annular support plate 102b and the second upper annular support plate 122b. The outer annular partition 111b is fixed by the lower annular sidewall 1012 of the lower cover housing 101 and the upper annular sidewall 1212 of the upper cover housing 121. The outer annular partition 111b surrounds the oxygenation membrane structure 115. In this embodiment, the middle annular partition 111a and the outer annular partition 111b each have a flow guiding structure composed of a plurality of blood inlets 1111 arranged in a ring. The positions of the plurality of blood inlets 1111 in the middle annular partition 111a are opposite to the positions of the plurality of blood inlets 1111 in the outer annular partition 111b. In this embodiment, the plurality of blood inlets 1111 in the middle annular partition 111a are closer to the lower cover 10, and the plurality of blood inlets 1111 in the outer annular partition 111b are closer to the upper cover 12. The spiral flow guiding integrated membrane oxygenator 1 of this embodiment increases the number of annular partitions, increases the diffusion distance of blood in the temperature-varying filament membrane structure 114 and the oxygenation filament membrane structure 115, thereby increasing the contact area and diffusion area of ​​blood with the plurality of temperature-varying filament membrane structures 114 and the oxygenation filament membrane structure 115, and improving the utilization rate of the temperature-varying filament membrane structure 114 and the oxygenation filament membrane structure 115. Furthermore, the multiple blood inlets 1111 of the outer annular septum 111b are located away from the outflow vessel 1121, preventing blood from flowing directly into the outflow vessel 1121 from the multiple blood inlets 1111 of the outer annular septum 111b. This further improves the utilization rate of the temperature-controlled membrane structure 114 and the oxygenated membrane structure 115. In this embodiment, the surface of the outer annular septum 111b is further provided with a filter for removing blood particles and gas microemboli.

[0062] Please see Figure 9 and Figure 10The figure shows a schematic diagram of the middle annular partition 111a and the outer annular partition 111b of the sixth embodiment of this application. As shown in the figure, following the fifth embodiment, the middle annular partition 111a and the outer annular partition 111b of this embodiment each have a plurality of uniformly distributed flow guiding holes 1113. Since the middle annular partition 111a and the outer annular partition 111b of this embodiment each have a plurality of flow guiding holes 1113, the provision of a plurality of blood inlets in the middle annular partition 111a and the outer annular partition 111b can be omitted. The aperture of the plurality of flow-guiding holes 1113 in the middle annular baffle 111a is larger than the aperture of the plurality of flow-guiding holes in the annular guide plate of the mandrel structure. The aperture of the plurality of flow-guiding holes 1113 in the outer annular baffle 111b is smaller than the aperture of the plurality of flow-guiding holes 1113 in the middle annular baffle 111a. The aperture of the plurality of flow-guiding holes 1113 in the middle annular baffle 111a and the outer annular baffle 111b, as well as the plurality of flow-guiding holes in the annular guide plate, is greater than 3 mm. Of course, the outer annular baffle 111b can be omitted, or the outer annular baffle 111b can be the same as the outer annular baffle in the fifth embodiment, which will not be described again here.

[0063] The multiple flow-guiding perforations 1113 of the middle annular septum 111a and the outer annular septum 111b primarily guide blood flow and divert blood. The blood flow rate and velocity within a single flow-guiding perforation 1113 are reduced, allowing the blood flowing out from each flow-guiding perforation 1113 to gently contact the oxygenated filament membrane structure. However, in this embodiment, each flow-guiding perforation 1113 of the middle annular septum 111a is a square hole, so blood collects in the multiple flow-guiding perforations 1113 of the middle annular septum 111a, and the multiple square holes 1113 can buffer the blood. No flow-guiding perforations 1113 are provided at the position of the outer annular partition 111b corresponding to the outlet vessel 1121 of the oxygenation shell 112. That is, the shortest distance between the center of the flow-guiding perforation 1113 of the outer annular partition 111b adjacent to the outlet vessel 1121 and the center of the outlet vessel 1121 is greater than 5mm. This prevents blood from flowing directly out from the multiple flow-guiding perforations 1113 near the outlet vessel 1121, allowing blood to flow out from the multiple flow-guiding perforations 1113 far away from the outlet vessel 1121, improving the utilization rate of the oxygenation membrane structure, and enabling blood to diffuse evenly.

[0064] In this embodiment, the inner surfaces of the middle annular partition 111a and the outer annular partition 111b are further provided with a plurality of spaced spiral guide grooves (such as... Figure 11As shown, the multiple flow guiding holes 1113 of the middle annular partition 111a and the outer annular partition 111b are respectively located within the multiple spiral flow guiding grooves of the middle annular partition 111a and the outer annular partition 111b. Each spiral flow guiding groove surrounds more than half a circle around the inner surface of the middle annular partition 111a or the outer annular partition 111b. In other words, the horizontal circumference length from one end to the other end of each spiral flow guiding groove is greater than the semicircular circumference of the middle annular partition 111a or the outer annular partition 111b. The vertical distance between one end and the other end of each spiral flow guiding groove is between one-half the height of the middle annular partition 111a or the outer annular partition 111b and two-thirds the height of the middle annular partition 111a or the outer annular partition 111b.

[0065] Please see Figure 11 Figure 10 is a cross-sectional view of the mandrel structure 110 according to the seventh embodiment of this application. As shown in the figure, the inner surface of the annular guide plate 1102 of the mandrel structure 110 of this embodiment has a plurality of spiral guide grooves 11022 spaced apart. A plurality of guide holes 11021 are located between the plurality of spiral guide grooves 11022. Each spiral guide groove 11022 surrounds more than half a circle around the inner surface of the annular guide plate 1102. In other words, the horizontal circumference length from one end of each spiral guide groove 11022 to its other end is greater than the semicircular circumference of the annular guide plate 1102. The vertical distance between one end of each spiral guide groove 11022 and its other end is between one-half the height of the annular guide plate 1102 and two-thirds the height of the annular guide plate 1102. The first end 1101a of the mandrel body 1101 has a flow-guiding arc surface 11011, and one end of each spiral flow-guiding groove 11022 is connected to the flow-guiding arc surface 11011. In other words, multiple spiral flow-guiding grooves 11022 are located on one side of the first end 1101a of the mandrel body 1101 and correspond to the second end 1101b of the mandrel body 1101. The flow-guiding arc surface 11011 of the mandrel body 1101 can buffer the blood flow rate and guide the blood to flow smoothly in the blood channel, so that the blood will not accumulate at the first end 1101a of the mandrel body 1101. However, multiple spiral guide grooves 11022 are directly connected to the guide arc surface 11011. The guide arc surface 11011 can directly guide blood to the multiple spiral guide grooves 11022. The blood quickly fills the multiple spiral guide grooves 11022. The multiple spiral guide grooves 11022 guide the blood to divert and flow out from the multiple guide perforations 11021 of the annular guide plate 1102. The multiple guide perforations 11021 of the annular guide plate 1102 can evenly divert the blood again, increasing the contact area and diffusion area between the blood and the variable temperature wire membrane structure, and increasing the utilization rate of the variable temperature wire membrane structure.

[0066] Please see Figure 12This is a schematic diagram of the filament membrane structure 13 according to the eighth embodiment of this application. As shown in the figure, the filament membrane structure 13 of this embodiment can be applied to the temperature-varying filament membrane structure and oxygenated filament membrane structure of the above embodiments. It includes multiple hollow fiber layers 131, each hollow fiber layer 131 having multiple hollow fiber tubes 1311. The multiple hollow fiber tubes 1311 are inclined at an angle relative to the vertical plane. The inclination direction of the multiple hollow fiber tubes 1311 of each hollow fiber layer 131 is different from the inclination direction of the multiple hollow fiber tubes 1311 of the adjacent hollow fiber layer 131. In other words, the multiple hollow fiber tubes 1311 of one hollow fiber layer 131 intersect with the multiple hollow fiber tubes 1311 of another hollow fiber layer 131. The angle between the hollow fiber tubes 1311 of each hollow fiber layer 131 and the vertical plane is 15 degrees. The cross-section of the hollow fiber tubes 1311 of each hollow fiber layer 131 is elliptical, which can reduce the blood prefilling volume. When blood flows into the space between the two adjacent hollow fiber layers 131 of the silk membrane structure 13, the blood can be divided into a thinner blood membrane, increasing the contact area between the blood and oxygen and improving the oxygenation efficiency of the blood.

[0067] In the above-described embodiments, the number of flow-guiding perforations, blood inlets, or spiral flow channels in the annular guide plate, annular partition, middle annular partition, and outer annular partition is one. Furthermore, the shortest distance between the center of the flow-guiding perforation of the middle annular partition 111 adjacent to the outlet blood vessel and the center of the outlet blood vessel is greater than 5 mm.

[0068] In summary, this application provides a spiral-guided integrated membrane oxygenator. The core structure has an annular guide plate, which guides blood flow through a flow-guiding structure with flow-guiding perforations and / or spiral flow-guiding grooves, and diverts the blood flow, increasing the blood diffusion area and the contact area between the blood and the membrane structure, effectively improving the utilization rate of the membrane structure and simultaneously enhancing the oxygenation efficiency of the spiral-guided integrated membrane oxygenator. The spiral-guided integrated membrane oxygenator of this application can be equipped with at least one annular partition, which supports the spiral-guided integrated membrane oxygenator and has a flow-guiding structure with flow-guiding perforations and / or spiral flow-guiding grooves, serving the same function as the flow-guiding structure of the annular guide plate. The small spacing between adjacent hollow fiber layers in the membrane structure of this application allows for further blood diversion, resulting in a thinner blood film and improved oxygenation efficiency. The cross-section of the hollow fiber tubes in each hollow fiber layer is circular, square, or elliptical, thus reducing the amount of pre-filled blood.

[0069] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0070] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A spiral-guided integrated membrane oxygenator, characterized in that, include: The lower cover has an air vent. The oxygenation section is disposed above the lower cover and includes a mandrel structure, an oxygenation shell, and an oxygenation filament membrane structure disposed between the mandrel structure and the oxygenation shell. The oxygenation shell has an outlet vessel, which is close to the lower cover. as well as The upper cover is located below the oxygenation section and is opposite to the lower cover. The upper cover has an inlet tube and an oxygen inlet tube. The oxygen inlet tube and the outlet tube connect the space between the spindle structure and the oxygenation shell. The mandrel structure includes a mandrel body and an annular guide plate. The mandrel body has a first end and a second end connected to the first end. A blood channel is provided between the first end and the upper cover. The annular guide plate is sleeved on the mandrel body and has multiple flow-guiding perforations. These perforations can guide blood radially, diverting blood flow to reduce the blood flow rate and velocity in each perforation. The multiple flow-guiding perforations are distributed on the annular guide plate. The inner surface of the annular guide plate has multiple spiral flow-guiding grooves spaced apart. The multiple flow-guiding perforations are located between the multiple spiral flow-guiding grooves. The spiral flow-guiding grooves guide blood flow and diffuse to fill the multiple spiral flow-guiding grooves, increasing the blood diffusion area and the contact area with the oxygenated fiber membrane structure. The oxygenated fiber membrane structure includes multiple hollow fiber layers, each hollow fiber layer having multiple hollow fiber tubes, the multiple hollow fiber tubes being tilted at an angle relative to the vertical plane, and the tilting direction of the multiple hollow fiber tubes in each hollow fiber layer being different from the tilting direction of the multiple hollow fiber tubes in the adjacent hollow fiber layers and intersecting each other.

2. The spiral-guided integrated membrane oxygenator according to claim 1, characterized in that, The hollow fiber tube of each hollow fiber layer forms an angle of 15 degrees with the vertical plane.

3. The spiral-guided integrated membrane oxygenator according to claim 1, characterized in that, Each of the flow-guiding perforations in the annular guide plate is a tapered hole, and the diameter of the flow-guiding perforation located on the inner side of the annular guide plate is smaller than the diameter of the flow-guiding perforation located on the outer side of the annular guide plate.

4. The spiral-guided integrated membrane oxygenator according to claim 1, characterized in that, The annular guide plate has multiple flow guiding holes, including at least one first flow guiding hole and at least one second flow guiding hole. The at least one first flow guiding hole of the annular guide plate is close to the lower cover, and the at least one second flow guiding hole of the annular guide plate is located above the at least one first flow guiding hole of the annular guide plate and close to the upper cover. The diameter of the at least one second flow guiding hole of the annular guide plate is larger than the diameter of the at least one first flow guiding hole of the annular guide plate.

5. The spiral-guided integrated membrane oxygenator according to claim 1, characterized in that, Each of the spiral guide grooves encircles more than half a circle around the inner surface of the annular guide plate.

6. The spiral-guided integrated membrane oxygenator according to claim 5, characterized in that, The horizontal circumference of each of the spiral guide grooves from one end to the other is greater than the semicircular circumference of the annular guide plate, and the vertical distance between the other end of each of the spiral guide grooves is between one-half and two-thirds of the height of the annular guide plate.

7. The spiral-guided integrated membrane oxygenator according to claim 1, characterized in that, It also includes an annular partition, which is disposed between the mandrel structure and the oxygenation shell, and the annular partition is provided with a flow guiding structure for guiding the diffusion and flow of blood; The lower cover has a water inlet pipe, and the upper cover has a water outlet pipe. The water inlet pipe and the water outlet pipe connect the space between the annular partition and the mandrel structure. The oxygen inlet pipe and the air outlet pipe connect the space between the annular partition and the oxygenation shell. A temperature-changing filament membrane structure is provided between the annular partition and the mandrel structure, and an oxygenation filament membrane structure is provided between the annular partition and the oxygenation shell. The temperature-changing filament membrane structure and the oxygenation filament membrane structure have the same structure.

8. The spiral-guided integrated membrane oxygenator according to claim 7, characterized in that, The annular partition has multiple blood inlets arranged in a ring as a flow guiding structure, and the multiple blood inlets are close to the lower cover.

9. The spiral-guided integrated membrane oxygenator according to claim 8, characterized in that, The outer surface of the annular partition is provided with a plurality of spiral guide grooves at intervals as a flow guiding structure, and the spiral guide grooves are located on one side of the plurality of blood inlets of the annular partition.

10. The spiral-guided integrated membrane oxygenator according to claim 9, characterized in that, One end of each of the spiral guide grooves is connected to the corresponding blood inlet.

11. The spiral-guided integrated membrane oxygenator according to claim 7, characterized in that, The annular partition has at least one flow-guiding perforation as a flow-guiding structure, and the flow-guiding perforation is distributed on the corresponding annular partition.

12. The spiral-guided integrated membrane oxygenator according to claim 1, characterized in that, It also includes a middle annular partition and an outer annular partition. The outer annular partition is disposed outside the middle annular partition and is adjacent to the oxygenation shell. The diameter of the middle annular partition is smaller than the diameter of the outer annular partition. The middle annular partition and the outer annular partition each have a plurality of blood passages arranged in a ring as a flow guiding structure. The positions of the plurality of blood passages in the middle annular partition are opposite to the positions of the plurality of blood passages in the outer annular partition.

13. The spiral-guided integrated membrane oxygenator according to claim 1, characterized in that, It also includes a middle annular partition and an outer annular partition. The outer annular partition is disposed outside the middle annular partition and is adjacent to the oxygenation shell. The middle annular partition and the outer annular partition each have a plurality of flow guiding holes as flow guiding structures. The aperture of the plurality of flow guiding holes in the middle annular partition is larger than the aperture of the plurality of flow guiding holes in the annular flow guiding plate of the mandrel structure. The aperture of the plurality of flow guiding holes in the outer annular partition is smaller than the aperture of the plurality of flow guiding holes in the middle annular partition.

14. The spiral-guided integrated membrane oxygenator according to claim 13, characterized in that, The diameter of the multiple flow-guiding perforations of the middle annular septum and the outer annular septum, as well as the multiple flow-guiding perforations of the annular flow-guiding plate, is greater than 3 mm, and the shortest distance between the center of the flow-guiding perforation of the outer annular septum adjacent to the outlet blood vessel and the center of the outlet blood vessel is greater than 5 mm.

15. The spiral-guided integrated membrane oxygenator according to claim 13, characterized in that, The inner surfaces of the middle annular partition and the outer annular partition are further provided with a plurality of spiral guide grooves spaced apart as a flow guiding structure, and the plurality of flow guiding holes of the middle annular partition and the outer annular partition are respectively located in the plurality of spiral guide grooves of the middle annular partition and the outer annular partition.

16. The spiral-guided integrated membrane oxygenator according to claim 15, characterized in that, The horizontal circumference of each spiral guide groove from one end to the other is greater than the semicircular circumference of the middle annular partition or the outer annular partition, and the vertical distance between one end and the other end of each spiral guide groove is between one-half and two-thirds of the height of the middle annular partition or the outer annular partition.

17. The spiral-guided integrated membrane oxygenator according to claim 15, characterized in that, The oxygenation section further includes an upper barrier structure and a lower barrier structure. The lower barrier structure passes through the mandrel structure and covers the lower cover. The upper barrier structure passes through the mandrel structure and is located below the upper cover. The two are arranged opposite to each other and are both located between the mandrel structure and the oxygenation shell.

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