CN111744065B

CN111744065B - Oxidized fiber film, oxidized part and oxygenator for ECMO

Info

Publication number: CN111744065B
Application number: CN202010602654.7A
Authority: CN
Inventors: 魏信鑫; 林伟东; 张换梅; 袁栋平
Original assignee: Dongguan Kewei Medical Instrument Co Ltd
Current assignee: Dongguan Kewei Medical Instrument Co Ltd
Priority date: 2020-06-29
Filing date: 2020-06-29
Publication date: 2023-07-18
Anticipated expiration: 2040-06-29
Also published as: CN111744065A

Abstract

The invention discloses an oxygenation silk membrane piece, which comprises a plurality of oxygenation silk membrane structures sleeved in sequence along the radial direction, wherein the density of silk membrane pores in unit area of the oxygenation silk membrane structures from inside to outside is gradually increased; the invention also discloses an oxygenation part which comprises a core shaft piece, an oxygenation wire film piece and an oxygenation shell; the oxygenation shell is sleeved outside the core shaft piece, and the oxygenation wire film piece is positioned between the core shaft piece and the oxygenation shell; the invention also discloses an oxygenator for ECMO, which comprises an oxygenation part. According to the blood exchange device, blood is subjected to blood oxygenation exchange mainly by the oxygenation membrane structure close to the inner side, which is smaller in resistance, and outflow circulation is performed by the oxygenation membrane structure close to the outer side, so that blood oxygenation exchange efficiency is considered, and meanwhile, the blood can be ensured to smoothly complete the whole exchange circulation under the condition of low pressure drop.

Description

Oxidized fiber film, oxidized part and oxygenator for ECMO

Technical Field

The invention relates to the technical field of oxygenators, in particular to an oxygenator for an oxygenating wire membrane, an oxygenating part and an ECMO.

Background

The membrane oxygenator is a medical instrument for replacing lungs by cardiac arrest, has the function of regulating the oxygen and carbon dioxide content in blood, is a necessary medical device for cardiovascular surgery, and is also a necessary medical device for treating acute respiratory diseases and waiting for a lung transplantation stage. The membrane oxygenator is based on the principle that venous blood in a body is led out of the body, oxygen and carbon dioxide are exchanged after passing through the membrane oxygenator to become arterial blood, and then arterial system of a patient is returned, so that supply of oxygenated blood of organ tissues of the human body is maintained, lung effect is temporarily replaced in the operation process, and meanwhile, a quiet, bloodless and clear operation environment is provided for doctors, so that the operation is conveniently implemented.

Because of the long period of blood circulation (a minimum of 24 hours, and possibly a maximum of more than one month) using the ECMO device, in order to ensure the temperature change and/or oxygen exchange efficiency of the blood after passing through the membrane oxygenator, the extracorporeal blood needs to be contacted with the silk membrane structure of the membrane oxygenator as much as possible, however, the larger the contact area between the blood and the silk membrane structure is hindered, the higher the pressure drop requirement is. How to ensure the completion of the circulation of the blood under the condition of low pressure drop while simultaneously taking the temperature change of the blood and/or the oxygen exchange efficiency into consideration is an urgent problem to be solved.

Disclosure of Invention

In order to overcome the defects in the prior art, the invention provides an oxidized fiber membrane piece, an oxidized part and an oxygenator for ECMO.

The invention discloses an oxygenation silk membrane, an oxygenation part and an oxygenator for ECMO, which comprises the following components:

an oxygenation silk membrane piece comprises a plurality of oxygenation silk membrane structures which are sleeved in sequence along the radial direction, and the density of silk membrane pores in unit area of the oxygenation silk membrane structures is gradually increased from inside to outside.

According to one embodiment of the invention, the oxidized fiber film structure comprises a first fiber layer and a second fiber layer which are adjacently arranged; the first fiber layer is provided with a plurality of first fiber pipes, the second fiber layer is provided with a plurality of second fiber pipes, and the first fiber pipes and the second fiber pipes are respectively arranged in a crossing manner to form a plurality of silk membrane pores; the area of the silk membrane pores gradually becomes smaller from inside to outside along the radial direction.

According to an embodiment of the invention, the cross section of the first fiber tube and/or the second fiber tube is a circular or non-circular closed cross section.

According to an embodiment of the invention, the first fiber tube and/or the second fiber tube are radially directed from the inside to the outside, the inner zone being a circular closed cross-section and the outer zone being a non-circular closed cross-section.

According to one embodiment of the invention, the first fiber tube and the second fiber tube are arranged from inside to outside along the radial direction, the inner side area adopts a hollow fiber membrane (such as a Polyester (PET) membrane) capable of realizing a temperature changing effect, and the outer side area adopts a hollow fiber membrane (such as a polypropylene (PP) membrane and a poly (4-methyl-1-pentene) (PMP) membrane) capable of realizing an oxygen and carbon dioxide exchanging effect.

According to one embodiment of the invention, the silk film pores are diamond-shaped.

According to an embodiment of the invention, the material from which the first fiber tube and/or the second fiber tube is made is poly 4-methyl-1-pentene (PMP).

According to one embodiment of the invention, the first fiber tube and the second fiber tube form an inclined angle with the central axis of the oxidized fiber membrane element respectively.

According to one embodiment of the invention, the inclination angle is 10-20 degrees.

An oxygenation part comprises a core shaft piece, the oxygenation wire film piece and an oxygenation shell; the oxygenation shell is sleeved outside the core shaft piece, and the oxygenation film piece is positioned between the core shaft piece and the oxygenation shell.

According to one embodiment of the invention, the mandrel member comprises a mandrel body and a fluid conductor; the mandrel body comprises a first end and a second end connected with the first end; the second end part is positioned below the first end part, the diameter of the second end part is larger than that of the first end part, and the first end part is provided with a diversion cambered surface; the flow guide body comprises a flow guide plate and a plurality of flow guide holes; the plurality of guide holes are uniformly distributed on the guide plate; the guide plate is sleeved outside the mandrel body.

According to an embodiment of the present invention, the flow guide body further comprises a plurality of spiral flow guide grooves; each spiral diversion trench is arranged on the inner wall of the diversion plate along the height direction of the diversion plate, and a plurality of spiral diversion trenches are sequentially arranged at intervals along the peripheral direction of the diversion plate; the plurality of diversion holes are sequentially arranged in the spiral diversion trenches at intervals from top to bottom.

According to an embodiment of the present invention, the oxygenation portion further includes an outer baffle; the outer flow guiding piece is positioned in the oxygenation shell and sleeved outside the oxygenation wire membrane piece, and a plurality of outer flow guiding holes are uniformly distributed on the outer flow guiding piece.

An oxygenator for ECMO includes the above-described oxygenating portion.

The beneficial effects of the application are that: the density of the silk membrane pores in the unit area of the inner to outer oxidized fiber membrane structure is gradually increased, so that the density of the silk membrane pores of the oxidized fiber membrane structure close to the outer side is higher than that of the silk membrane pores of the oxidized fiber membrane structure close to the inner side, the resistance of the oxidized fiber membrane structure close to the inner side to blood is smaller than that of the oxidized fiber membrane structure close to the outer side, the blood can smoothly and smoothly pass through the oxidized fiber membrane structure close to the inner side under the condition of low pressure drop, then enters the oxidized fiber membrane structure close to the outer side, and further, the blood guided out by the mandrel is subjected to blood oxygenation exchange mainly by the oxidized fiber membrane structure close to the inner side with smaller resistance, and then flows outwards through the oxidized fiber membrane structure close to the outer side, so that the whole exchange cycle of the blood can be smoothly completed under the condition of low pressure drop while the temperature change and/or the oxygenation exchange efficiency of the blood are simultaneously realized, and the hollow fiber membrane manufactured by poly 4-methyl 1-pentene (PMP) has better oxygen flux and supports a longer blood cycle period.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiments of the application and together with the description serve to explain the application and do not constitute an undue limitation to the application. In the drawings:

FIG. 1 is a schematic structural view of an oxidized fiber membrane structure according to a first embodiment;

FIG. 2 is a cross-sectional view of an oxygenator for ECMO in an embodiment I;

FIG. 3 is an exploded view of an oxygenator for ECMO in accordance with the first embodiment;

FIG. 4 is a schematic structural diagram of a mandrel body in a second embodiment;

FIG. 5 is a schematic diagram of a flow guide body in a second embodiment;

FIG. 6 is a schematic structural view of an oxygenator for ECMO in a third embodiment;

fig. 7 is a schematic structural diagram of an upper cover in the third embodiment.

Detailed Description

Various embodiments of the invention are disclosed in the following drawings, in which details of the practice are set forth in the following description for the purpose of clarity. However, it should be understood that these practical details are not to be taken as limiting the invention. That is, in some embodiments of the invention, these practical details are unnecessary. Moreover, for the purpose of simplifying the drawings, some conventional structures and components are shown in the drawings in a simplified schematic manner.

It should be noted that all directional indications such as up, down, left, right, front, and rear … … in the embodiments of the present invention are merely used to explain the relative positional relationship, movement, etc. between the components in a particular posture such as that shown in the drawings, and if the particular posture is changed, the directional indication is changed accordingly.

In addition, the descriptions of the "first," "second," and the like, herein are for descriptive purposes only and are not intended to be specifically construed as order or sequence, nor are they intended to limit the invention solely for distinguishing between components or operations described in the same technical term, but are not to be construed as indicating or implying any relative importance or order of such features. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In addition, the technical solutions of the embodiments may be combined with each other, but it is necessary to base that the technical solutions can be realized by those skilled in the art, and when the technical solutions are contradictory or cannot be realized, the combination of the technical solutions should be considered to be absent and not within the scope of protection claimed in the present invention.

For a further understanding of the invention, its features and advantages, reference is now made to the following examples, which are illustrated in the accompanying drawings in which:

example 1

Referring to fig. 1 to 3, fig. 1 is a schematic structural view of an oxygenating filament membrane structure in the first embodiment, fig. 2 is a sectional view of an oxygenator for ECMO in the first embodiment, and fig. 3 is an exploded view of the oxygenator for ECMO in the first embodiment. The oxidized fiber membrane piece 22 in this embodiment includes a plurality of oxidized fiber membrane structures 221 sleeved in sequence along the radial direction, and the density of the fiber membrane pores per unit area of the oxidized fiber membrane structures 221 is gradually increased from inside to outside.

Specifically, the plurality of oxidized fiber membrane structures 221 sequentially sleeved from the inside to the outside have a hollow cylindrical shape, so that the oxidized fiber membrane member 22 is a hollow cylinder having a radial direction and an axial direction. Each of the oxidized fiber film structures 221 includes a first fiber layer 2211 and a second fiber layer 2212 disposed adjacently. The first fiber layer 2211 has a plurality of first fiber tubes 22111, the second fiber layer 2212 has a plurality of second fiber tubes 22121, and the cross section of the first fiber tubes 22111 and/or the second fiber tubes 22121 is a circular or non-circular closed cross section.

Further, the first fiber tube 22111 and/or the second fiber tube 22121 are radially from inside to outside, the first fiber tube 22111 and/or the second fiber tube 22121 of the inner region (not shown) is a circular closed section, and the first fiber tube 22111 and/or the second fiber tube 22121 of the outer region (not shown) is a non-circular closed section; furthermore, the inner side area adopts a hollow fiber membrane (such as a polyester PET membrane) capable of realizing a temperature change effect, and the outer side area adopts a hollow fiber membrane (such as a polypropylene PP membrane, a poly 4-methyl 1-pentene PMP membrane and the like) capable of realizing an oxygen and carbon dioxide exchange effect. According to the principle of equal circumference: when the area enclosed by the closed curves on the plane is fixed, the circumference of the circular curve is minimum, so that a non-circular closed section fiber tube is adopted to realize that a larger contact area exists between gas molecules and blood under the same flow, so that more gas molecules and blood are exchanged, and further the oxygenation efficiency of the blood and oxygen is improved; hollow fiber membranes made with poly-4-methyl-1-pentene (PMP) have better oxygen flux and support longer blood circulation cycles.

The first fiber tubes 22111 and the second fiber tubes 22121 are respectively arranged in a crossing manner, so as to form a plurality of silk film pores 2213. Along the radial direction of the oxidized fiber membrane element 22, the area of the inner to outer fiber membrane aperture 2213 becomes gradually smaller. Preferably, the wire film apertures 2213 are diamond-shaped.

The first fiber tubes 22111 are sequentially arranged at intervals along the circumferential direction, and each first fiber tube 22111 is obliquely arranged, specifically, the first fiber tube 22111 and the central axis of the oxidized fiber membrane 22 form an oblique included angle by being obliquely arranged from the axial direction of the oxidized fiber membrane 22 to the direction away from the axial direction, and the oblique included angle of the first fiber tube 22111 in the embodiment is 10-20 degrees, preferably 15 degrees. The arrangement of the plurality of second fiber tubes 22121 is identical to the arrangement of the plurality of first fiber tubes 22111, and the difference is that the inclination direction of the second fiber tubes 22121 is opposite to the inclination direction of the first fiber tubes 22111, so that the plurality of first fiber tubes 22111 and the plurality of second fiber tubes 22121 intersect, and the plurality of first fiber tubes 22111 and the plurality of second fiber tubes 22121 which are arranged in an intersecting manner form a plurality of diamond-shaped wire film holes 2213.

In the present embodiment, the density of the silk film pores 2213 in a unit area, that is, the number of the silk film pores 2213 in a unit area is small, when the number of the silk film pores 2213 in a unit area is large, the density is large, otherwise, the density is small. For example, the hollow cylindrical oxidized fiber membrane structure 221 is rectangular after being laid out, and the larger the number of fiber membrane pores 2213 in the rectangular surface, the more densely the structure, i.e., the higher the degree of densification. When the number of the wire film holes 2213 per unit area is greater, the area of the single wire film hole 2213 is smaller. That is, the density of the wire film holes 2213 per unit area becomes gradually large, and the area of the wire film holes 2213 becomes gradually small along the radial direction of the oxygenation casing 23. The greater the concentration of the wire membrane pores 2213, the greater the resistance to blood passage, whereas the lesser the concentration of the wire membrane pores 2213, the lower the resistance to blood passage. In this embodiment, the density of the silk membrane pores in the unit area of the outer oxidized fiber membrane structure 221 near the inner side is smaller than that of the silk membrane pores in the unit area of the outer oxidized fiber membrane structure 221 near the outer side, so that the blood can smoothly and smoothly pass through the inner side under the condition of low pressure drop. The pressure drop required for blood to pass through is lower when the density of silk membrane pores per unit area is uniform relative to the inner and outer oxygenation silk membrane structures 221. In other words, when blood flows radially along the oxidized fiber membrane member 22 from inside to outside, that is, the blood passes through the oxidized fiber membrane structures 221 from inside to outside, the area of the fiber membrane pores 2213 passing through the oxidized fiber membrane structures is gradually reduced, that is, the blocking pressure of the oxidized fiber membrane structures 221 close to the inner side to the blood is smaller, so that the blood can smoothly pass through the oxidized fiber membrane structures 221 close to the inner side under the condition of low pressure drop, the main blood exchange function is completed, and then flows out through the oxidized fiber membrane structures 221 close to the outer side, thereby ensuring that the exchange cycle of the blood can be smoothly completed under the condition of low pressure drop while the blood exchange efficiency is considered. The first fiber tube 22111 and the second fiber tube 22121 in the present embodiment are hollow fiber tubes.

Example two

Referring to fig. 4 and fig. 5 together, fig. 4 is a schematic structural diagram of the mandrel body in the second embodiment, and fig. 5 is a schematic structural diagram of the fluid guide body in the second embodiment. The oxygenation section 2 in this embodiment includes a core shaft member 21, an oxygenation filament membrane member 22, and an oxygenation housing 23. The oxygenation casing 23 is sleeved outside the mandrel 21, and the oxygenation film 22 is located between the mandrel 21 and the oxygenation casing 23. The oxidized fiber membrane 22 is the oxidized fiber membrane in the first embodiment, and will not be described herein.

Specifically, the mandrel 21 includes a mandrel body 211 and a fluid director 212. The flow guide body 212 is sleeved outside the mandrel body 211. Wherein the mandrel body 211 includes a first end 2111 and a second end 2112 connected to the first end 2111. The second end portion 2112 is located below the first end portion 2111, the diameter of the second end portion 2112 is larger than the diameter of the first end portion 2111, and the first end portion 2111 has a diversion arc surface 21111. Specifically, the first end portion 2111 is columnar, and from an upper end of the first end portion 2111 to a lower end of the first end portion 2111, a diameter of the first end portion 2111 becomes gradually larger, so that an outer wall of the first end portion 2111 forms a diversion cambered surface 21111. The second end portion 2112 has a cylindrical shape, and an upper end thereof is integrally formed with a lower end of the first end portion 2111. The lower end of second end portion 2112 is connected to the lower end of current carrier 212. Baffle 212 includes a baffle 2121 and a plurality of baffle holes 2122. The guide plate 2121 is sleeved outside the mandrel body 211, and a plurality of guide holes 2122 are uniformly distributed on the guide plate 2121. The baffle 2121 is hollow and cylindrical, and is sleeved outside the spindle body 211. A blood channel is formed between the spindle body 211 and the baffle 2121, and the lower end of the baffle 2121 is connected to the lower end of the second end portion 2112. Preferably, the baffle 212 further includes a plurality of helical baffle slots 2123. Each spiral guide groove 2123 is disposed on the inner wall of the guide plate 2121 along the height direction of the guide plate 2121, and the plurality of spiral guide grooves 2123 are sequentially arranged at intervals along the circumferential direction of the guide plate 2121. The plurality of diversion holes 2122 are sequentially arranged in the spiral diversion trench 2123 at intervals from top to bottom. Preferably, the aperture of the baffle 2122 gradually increases from a side near the inner wall of the baffle 2121 toward a side of the outer wall of the baffle 2121, so that the baffle 2122 is approximately horn-shaped. Through the cooperation of spiral guiding gutter 2123 and water conservancy diversion hole 2122 and the supplementary of water conservancy diversion hole 2122 loudspeaker form shape for under the low pressure drop's the circumstances, the blood in the blood passageway can be smooth and smooth water conservancy diversion to oxygenation silk membrane piece 22, and the reposition of redundant personnel is even. The upper and lower ends of the baffle 2121 are provided with bearing clamping grooves 21211, and the bearing clamping grooves 21211 are annular grooves which are annularly arranged on the end surfaces of the upper and lower ends of the baffle 2121.

The oxygenation casing 23 is hollow and cylindrical, and has a blood outlet tube 231 formed in the outer wall thereof, the blood outlet tube 231 being located near the lower end of the oxygenation casing 23, and the blood outlet tube 231 being in communication with the inner wall of the oxygenation casing 23. The oxygenation housing 23 is provided at a lower end thereof with a plurality of lower clamping blocks 232 and at an upper end thereof with a plurality of upper clamping blocks 233. The plurality of lower clips 232 are disposed on the outer wall of the oxygenation housing 23 along the circumferential direction of the oxygenation housing 23, and the plurality of upper clips 233 are disposed on the outer wall of the oxygenation housing 23 along the circumferential direction of the oxygenation housing 23. Preferably, the outer wall of the oxygenation housing 23 is further provided with a circulation exhaust duct 234, the circulation exhaust duct 234 being located above the outlet vessel 231, close to the upper end of the oxygenation housing 23. The circulation exhaust pipe 234 is communicated with the inner wall of the oxygenation casing 23 such that the space between the mandrel 21 and the oxygenation casing 23 is communicated with the circulation exhaust pipe 234, and the gas generated by the rupture of the plurality of first fiber pipes 22111 and the plurality of second fiber pipes 22121 is exhausted from the circulation exhaust pipe 234.

Preferably, the oxygenation 2 further comprises an outer flow guide 24. The outer flow guide member 24 is hollow and cylindrical, is positioned in the oxygenation casing 23, and is sleeved outside the oxygenation wire membrane 22. A plurality of outer guide holes 241 are uniformly distributed on the outer guide member 24. The utilization of the oxywire membrane 22 is enhanced by the outer baffle orifice 241 of the outer baffle 24. Preferably, the outer wall of the outer guide 24 is provided with a plurality of outer guide grooves 242, each outer guide groove 242 is disposed along the height direction of the outer guide 24, and the plurality of outer guide grooves 242 are sequentially arranged along the circumference of the outer guide 24. The plurality of outer guide holes 241 are sequentially provided along the height direction of the outer guide groove 242. Preferably, the aperture of the outer guide hole 241 is gradually increased from the inner wall near the outer guide 24 to the outer wall near the outer guide 24, so that the outer guide hole 241 is approximately horn-shaped. In this way, the smoothness of the blood circulation flow can be increased.

Referring to fig. 6 and 7 together, fig. 6 is a schematic structural view of an ECMO oxygenator according to a third embodiment, and fig. 7 is a schematic structural view of an upper cover according to the third embodiment. The ECMO oxygenator in this embodiment includes a lower cap 1, an oxygenating portion 2, and an upper cap 3. The oxygenation section 2 is provided in the lower cover 1. The upper cover 3 is provided on the oxygenation portion 2. The oxygenation portion 2 is the oxygenation portion in the second embodiment, and will not be described here again.

The lower cover 1 comprises an outlet duct 11, a lower cover bottom plate 12, a lower cover side plate 13 and a spindle support 14. The mandrel support 14 is arranged on the lower cover bottom plate 12, and the lower cover side plate 13 is arranged on the lower cover bottom plate 12 and sleeved outside the mandrel support 14. The air outlet pipe 11 is arranged on the lower cover bottom plate 12 and is communicated with the space between the lower cover side plate 13 and the mandrel support piece 14. The mandrel member 21 is provided on the mandrel support member 14, the oxygenation casing 23 is provided on the lower cover side plate 13, and the lower end surface of the oxygenation wire film member 22 faces the space between the lower cover side plate 13 and the mandrel support member 14. Specifically, the lower cover bottom plate 12 is approximately disk-shaped. The lower cover side plate 13 is hollow and cylindrical, is provided on the upper surface of the lower cover bottom plate 12, and is approximately formed in a cover shape in cooperation with the lower cover bottom plate 12. The mandrel support 14 is hollow and cylindrical, and is provided on the upper surface of the lower cover bottom plate 12, the central axis of the mandrel support overlaps the central axis of the lower cover side plate 13, and an annular space is formed between the lower cover side plate 13 and the mandrel support 14. An annular space is formed between the lower end of the oxidized fiber membrane element 22, which is aligned with the lower cover side plate 13 and the mandrel support 14. The air outlet pipe 11 is arranged on the lower surface of the lower cover bottom plate 12 and is communicated with an annular space between the lower cover side plate 13 and the mandrel support piece 14. Preferably, the lower cover side plate 13 is provided with a plurality of lower clamping grooves 131, the plurality of lower clamping grooves 131 are sequentially arranged at intervals along the periphery of the lower cover side plate 13, and the lower clamping blocks 232 are matched with the lower clamping grooves 131. The plurality of lower clamping grooves 131 are used for stably bearing the oxygenation casing 23. The lower cover 1 is further provided with a lower blocking structure (not shown in the figure) connected with the lower end of the oxygenation wire film member 22, which is formed by centrifugal glue filling and the like, so that blood in the oxygenation wire film member 22 can be blocked from moving into the lower cover 1, and the existing blocking structure is adopted in practical application and is not repeated here. Preferably, the lower cover bottom plate 12 is obliquely arranged, so that one side of the lower cover bottom plate 12 is close to the lower end of the oxidized fiber membrane element 22, the other side of the lower cover bottom plate 12 is far away from the lower end of the oxidized fiber membrane element 22, and the air outlet pipe 11 is arranged on one side of the lower cover bottom plate 12 far away from the lower end of the oxidized fiber membrane element 22. In this way, the annular space between the lower cover side plate 13 and the mandrel support 14 forms a deeper part and a shallower part, and the air outlet pipe 11 is communicated with the deeper part of the annular space between the lower cover side plate 13 and the mandrel support 14, so that the carbon dioxide gas after exchange can be collected and discharged conveniently. Preferably, the side of the lower cover bottom plate 12 facing away from the lower cover side plate 13 is also provided with a lower reinforcing plate 14. The strength of the lower cover 1 is enhanced by the provision of the lower reinforcing plate 14.

The upper cover 3 includes a blood inlet tube 31, an air inlet tube 32, an upper cover bottom plate 33, an upper cover side plate 34, and a spindle communication 35. The spindle communication member 35 is provided on the upper cover bottom plate 33 and communicates with the spindle member 21. The upper cover side plate 34 is arranged on the upper cover bottom plate 33 and sleeved outside the mandrel communicating piece 35. The intake duct 31 communicates with the spindle communication member 35, and the intake duct 32 communicates with a space between the upper cover side plate 34 and the spindle communication member 35. The upper cover side plate 34 is connected to the oxygenation casing 23, and the upper end face of the oxygenation wire film 22 faces the space between the upper cover side plate 34 and the spindle communication member 35. Specifically, the upper cover bottom plate 33 has a disk shape. The upper cover side plate 34 is hollow and cylindrical, is perpendicular to the lower surface of the upper cover bottom plate 33, and is formed in a cover shape by being matched with the upper cover bottom plate 33. The mandrel communication 35 includes a communication side plate 351, a breathable film carrier 352, and a breathable film (not shown). The communication side plate 351 is provided on the upper cover bottom plate 33 and communicates with the outer wall of the upper cover bottom plate 33. The air permeable membrane carrier 352 is disposed in the communicating side plate 351 and above the blood inlet tube 31. The breathable film is disposed on the breathable film carrier 352. Wherein, the communication side plate 351 includes a first through cylinder 3511 and a second through cylinder 3512. The first through cylinder 3511 is vertically disposed on the lower surface of the upper cover bottom plate 33, the second through cylinder 3512 is vertically disposed on the upper surface of the upper cover bottom plate 33, and the first through cylinder 3511 is communicated with the second through cylinder 3512. The first through cylinder 3511 and the second through cylinder 3512 in the present embodiment are hollow cylinders, and the diameter of the first through cylinder 3511 is larger than the diameter of the second through cylinder 3512. Preferably, the centerline axes of the first through-tube 3511, the second through-tube 3512, and the upper cover side plate 34 overlap. The first through-tube 3511 forms an annular space with the upper cover side plate 34. The air permeable membrane carrier 352 is disposed in the first through cylinder 3511 and is close to the upper cover bottom plate 33. The breathable film is disposed on the breathable film carrier 352. The blood inlet tube 31 passes through the upper cover side plate 34 and then communicates with the first through tube 3511. The air inlet pipe 32 is specifically connected to the annular space between the upper cover side plate 34 and the first through cylinder 3511. The upper cover side plate 34 is provided with a plurality of upper clamping grooves 341 along the peripheral direction of the upper cover side plate, the plurality of upper clamping grooves 341 are sequentially arranged at intervals, and the upper clamping grooves 341 are matched with the upper clamping blocks 233. The annular space between the upper cover side plate 34 and the first through cylinder 3511 is opposite the upper end of the oxidized wire film member 22. Preferably, the side of the upper cover bottom plate 33 facing away from the upper cover side plate 34 is also provided with an upper reinforcing plate 36. The strength of the upper cover 3 is enhanced by the provision of the upper reinforcing plate 36. Correspondingly, the upper cover 3 is further provided with an upper blocking structure (not shown in the figure) connected with the upper end of the oxygenation wire membrane piece 22, which is formed by centrifugal glue filling and the like, so that blood in the oxygenation wire membrane piece 22 can be blocked from moving into the upper cover 3, and the existing blocking structure is adopted in practical application, so that the repeated description is omitted.

When assembled, the bearing clamping groove 21211 at the lower end of the guide plate 2121 is clamped at the upper end of the mandrel support 14. The first through cylinder 3511 is opposite to and clamped in the bearing clamping groove 21211 at the upper end of the guide plate 2121. The upper end of the oxygenation casing 23 is disposed in the upper cover side plate 34, and a plurality of upper clamping blocks 233 are respectively and adaptively clamped in a plurality of upper clamping grooves 341. The lower end of the oxygenation casing 23 is disposed in the lower cover side plate 13, and a plurality of lower clamping blocks 232 are respectively and adaptively clamped in a plurality of lower clamping grooves 233.

The blood circulation process in this example is as follows: blood in a human body enters the first through cylinder 3511 from the blood inlet tube 31 to form a blood vortex, gas in the blood is separated and ventilated through the ventilated membrane by centrifugal force generated by vortex, the blood falls into a blood channel between the mandrel body 211 and the deflector 2121, the blood is uniformly split towards the deflector 2121 from the deflector cambered surface 21111 of the first end 2111, then split into the oxidized fiber membrane piece 22 from the deflector hole 2122, the oxidized fiber membrane structure 221 close to the inner side is diffused towards the oxidized fiber membrane structure 221 close to the outer side, the blood and oxygen are oxidized in the oxidized fiber membrane structure 221 and carbon dioxide is removed, the oxidized blood circulates into the human body from the blood outlet tube 231, and the carbon dioxide gas is discharged from the air outlet tube 11.

In summary, the density of the silk membrane pores in the unit area of the inner to outer oxidized fiber membrane structure is gradually increased, so that the density of the silk membrane pores of the oxidized fiber membrane structure close to the outer side is higher than that of the silk membrane pores of the oxidized fiber membrane structure close to the inner side, the resistance of the oxidized fiber membrane structure close to the inner side to blood is smaller than that of the oxidized fiber membrane structure close to the outer side, the blood can smoothly and smoothly pass through the oxidized fiber membrane structure close to the inner side under the condition of low pressure drop, then enters the oxidized fiber membrane structure close to the outer side, and the blood guided out by the mandrel is subjected to blood oxygenation exchange mainly by the oxidized fiber membrane structure close to the inner side with smaller resistance, and then flows outwards through the oxidized fiber membrane structure close to the outer side, so that the whole exchange cycle of the blood can be smoothly completed under the condition of low pressure drop while the temperature change and/or the oxygenation exchange efficiency of the blood is guaranteed, and the hollow fiber membrane manufactured by poly 4-methyl 1-pentene (PMP) has better oxygen flux and supports a longer blood cycle period.

The above are merely embodiments of the present invention, and are not intended to limit the present invention. Various modifications and variations of the present invention will be apparent to those skilled in the art. Any modification, equivalent replacement, improvement, or the like, which is within the spirit and principles of the present invention, should be included in the scope of the claims of the present invention.

Claims

1. An oxygenation part is characterized by comprising a core shaft piece, an oxygenation wire film piece and an oxygenation shell; the oxygenation shell is sleeved outside the core shaft piece, and the oxygenation wire film piece is positioned between the core shaft piece and the oxygenation shell; the oxygenation wire membrane piece comprises a plurality of oxygenation wire membrane structures which are sleeved in sequence along the radial direction, and the density of wire membrane pores in the unit area of the oxygenation wire membrane structure is gradually increased from inside to outside; the oxidized fiber film structure comprises a first fiber layer and a second fiber layer which are adjacently arranged; the first fiber layer is provided with a plurality of first fiber pipes, the second fiber layer is provided with a plurality of second fiber pipes, and the first fiber pipes and the second fiber pipes are respectively arranged in a mutually crossing way to form a plurality of silk membrane pores; the oxidized fiber membrane element is configured to: the areas of the silk membrane pores of the plurality of the oxidized silk membrane structures gradually decrease from inside to outside along the radial direction; the first fiber tube and the second fiber tube respectively form an inclined included angle with the central axis of the oxygenation wire film; the first fiber tube and/or the second fiber tube are/is in a circular closed section along the radial direction from inside to outside, and the first fiber tube and/or the second fiber tube in the inner side area are/is in a non-circular closed section;

the core shaft piece comprises a core shaft body and a current carrier; the mandrel body comprises a first end and a second end connected with the first end; the second end part is positioned below the first end part, the diameter of the second end part is larger than that of the first end part, and the first end part is provided with a diversion cambered surface; the fluid director comprises a fluid director plate and a plurality of fluid director holes; the plurality of flow guide holes are uniformly distributed on the flow guide plate; the guide plate is sleeved outside the mandrel body; the flow guide body further comprises a plurality of spiral flow guide grooves; each spiral diversion trench is arranged on the inner wall of the diversion plate along the height direction of the diversion plate, and a plurality of spiral diversion trenches are sequentially arranged at intervals along the peripheral direction of the diversion plate; the plurality of diversion holes are sequentially arranged in the spiral diversion trench at intervals from top to bottom; the aperture of the deflector hole gradually increases from one side close to the inner wall of the deflector to one side of the outer wall of the deflector; the oxygenation portion further comprises an outer flow guiding piece, the outer flow guiding piece is located in the oxygenation shell and sleeved outside the oxygenation wire film piece, a plurality of outer flow guiding holes are uniformly distributed in the outer flow guiding piece, a plurality of outer flow guiding grooves are formed in the outer wall of the outer flow guiding piece, each outer flow guiding groove is arranged along the height direction of the outer flow guiding piece, the plurality of outer flow guiding grooves are sequentially arranged along the periphery of the outer flow guiding piece, the plurality of outer flow guiding holes are sequentially arranged along the height direction of the outer flow guiding grooves, and the aperture of each outer flow guiding hole is gradually increased from the inner wall of the outer flow guiding piece to the direction close to the outer wall of the outer flow guiding piece.

2. The oxygenation of claim 1 wherein the silk membrane pores are diamond-shaped.

3. The oxygenation of claim 1, wherein the material of the first fiber tube and/or the second fiber tube is poly 4-methyl-1-pentene (PMP).

4. An oxygenator for ECMO, comprising: an oxygenating part as claimed in any one of claims 1 to 3.