CN111701103B

CN111701103B - Pump-free artificial membrane lung for ECMO

Info

Publication number: CN111701103B
Application number: CN202010602646.2A
Authority: CN
Inventors: 周成斌; 魏信鑫; 林伟东; 张换梅; 袁栋平; 陈寄梅
Original assignee: GUANGDONG CARDIOVASCULAR INSTITUTE; Dongguan Kewei Medical Instrument Co Ltd
Current assignee: GUANGDONG CARDIOVASCULAR INSTITUTE; Dongguan Kewei Medical Instrument Co Ltd
Priority date: 2020-06-29
Filing date: 2020-06-29
Publication date: 2023-03-03
Anticipated expiration: 2040-06-29
Also published as: CN111701103A

Abstract

The invention discloses a pump-free ECMO artificial membrane lung, which comprises a lower cover, an oxygenation part and an upper cover, wherein the oxygenation part is arranged on the lower cover, the oxygenation part comprises a core shaft part, an oxygenation filament membrane part and an oxygenation shell, the core shaft part comprises a core shaft body and a flow guide body, the flow guide body is sleeved outside the core shaft body, the oxygenation shell is sleeved outside the flow guide body, the oxygenation filament membrane part is positioned between the flow guide body and the oxygenation shell, the oxygenation filament membrane part comprises a plurality of oxygenation filament membrane structures, the oxygenation filament membrane structures are sequentially sleeved along the radial direction of the oxygenation shell, the concentration degree of filament membrane pores in a unit area of the oxygenation filament membrane structure from inside to outside is gradually increased, the upper cover is arranged on the oxygenation part, a blood inlet pipe of the upper cover is communicated with the core shaft part, and an air inlet pipe of the upper cover is communicated with a space between the core shaft part and the oxygenation shell. This application is artificial membrane lung for no pump type ECMO can guarantee again that blood accomplishes whole exchange cycle smoothly under the condition of low pressure drop when taking into account blood oxygenation exchange efficiency.

Description

Pump-free artificial membrane lung for ECMO

Technical Field

The invention relates to the technical field of oxygenators, in particular to a pump-free artificial membrane lung for ECMO.

Background

The novel coronavirus pneumonia outbreak at the end of 2019 has extremely strong infectivity, so that critical pneumonia caused by the extremely strong infectivity easily generates pathophysiological changes similar to acute respiratory distress syndrome, a patient is caused to have severe hypoxia and hypercapnia, and the mortality rate of the patient is high. In the scheme for diagnosing and treating severe pneumonia and severe cases with novel coronavirus infection (trial) published by the national Wei Jian committee, it is proposed that Extracorporeal Membrane Oxygenation (ECMO) therapy can be considered for critically ill patients.

ECMO is used for improving severe hypoxia and hypercapnia of patients and avoiding damage of high mechanical ventilation parameters of a breathing machine. However, the existing ECMO devices are imported products, and consist of a centrifugal pump and an oxygenator, so that the cost is high, certain complications exist in the management process, medical staff can repeatedly evaluate and benefit and risk before decision making, and an optimal treatment window can be missed. One of the methods for changing the current situation is to develop a domestic long-time artificial membranous lung capable of temporarily replacing a damaged lung, so that the lung can rest, anoxia and hypercapnia are improved, and the survival rate of a novel coronavirus pneumonia critical patient is improved.

In the conventional extracorporeal circulation operation, the extracorporeal circulation pipeline of blood is long, so that an oxygenator with a pump is needed, and the blood can complete extracorporeal circulation with long pipeline by the pressure provided by the pump (a rolling pump, a centrifugal pump or the like). Moreover, because the extracorporeal circulation circuit is long, a temperature changing area is often arranged in the oxygenator with the pump so as to ensure the temperature of the blood during the extracorporeal circulation. If the extracorporeal circulation pipeline of the blood is short, a pump-free oxygenator can be adopted to provide the pressure of the extracorporeal circulation of the blood through the human body, and the extracorporeal circulation pipeline is short, so that the extracorporeal circulation of the blood can be free of a temperature change region. As disclosed in patent document CN107362399a entitled "spiral flow guide integrated membrane oxygenator", a membrane oxygenator with and without a temperature changing region is disclosed.

Because the pump-free oxygenator needs to perform extracorporeal blood circulation through the pressure of the human body, the pressure drop of the pump-free oxygenator is low so as to reduce the obstruction to the blood, and the extracorporeal blood circulation can be completed under the condition that the pump is free from external pressure. However, in order to ensure the efficiency of oxygen and carbon dioxide exchange after the blood passes through the membrane oxygenator, the extracorporeal blood needs to be in contact with the filament membrane structure of the membrane oxygenator as much as possible, however, the larger the contact area of the blood and the filament membrane structure is, the larger the resistance is, and the higher the requirement on pressure drop is. How to complete the exchange circulation under the condition of low pressure drop while considering the oxygenation exchange efficiency of blood is an urgent problem to be solved.

Disclosure of Invention

Aiming at the defects of the prior art, the invention provides a pump-free artificial membrane lung for ECMO.

The invention discloses a pumpless artificial membrane lung for ECMO, which comprises:

a lower cover including an outlet duct;

an oxygenation part arranged on the lower cover; the oxygenation part comprises a mandrel piece, an oxygenation filament membrane piece and an oxygenation shell; the oxygenation shell is sleeved outside the mandrel component, and the oxygenation filament membrane component is positioned between the mandrel component and the oxygenation shell; the oxygenation silk membrane piece comprises a plurality of oxygenation silk membrane structures, the oxygenation silk membrane structures are sequentially sleeved along the radial direction of the oxygenation shell, and the density of the pores of the oxygenation silk membrane in unit area of the oxygenation silk membrane structure is gradually increased from inside to outside; the oxygenation shell is provided with a blood outlet pipe which is close to the lower cover; and

an upper cover arranged on the oxygenation part; the upper cover comprises a blood inlet pipe and an air inlet pipe; the blood inlet pipe is communicated with the mandrel part, and the air inlet pipe is communicated with the space between the mandrel part and the oxygenation shell.

According to an embodiment of the present invention, the lower cover further comprises a lower cover bottom plate, a lower cover side plate and a mandrel support; the mandrel support piece is arranged on the lower cover bottom plate, and the lower cover side plate is arranged on the lower cover bottom plate and sleeved outside the mandrel support piece; the air outlet pipe is arranged on the bottom plate of the lower cover and communicated with a space between the side plate of the lower cover and the mandrel support piece; the mandrel support piece is arranged on the mandrel piece, the oxygenation shell is arranged on the lower cover side plate, and the lower end face of the oxygenation silk membrane piece is downwards covered on the space between the lower cover side plate and the mandrel support piece.

According to an embodiment of the present invention, the upper cover further comprises an upper cover bottom plate, an upper cover side plate, and a mandrel communicating member; the mandrel communicating piece is arranged on the upper cover bottom plate and communicated with the mandrel piece; the upper cover side plate is arranged on the upper cover bottom plate and sleeved outside the mandrel communicating piece; the air inlet pipe is communicated with a space between the upper cover side plate and the mandrel communicating piece; the upper cover side plate is connected with the oxygenation shell, and the upper end of the oxygenation silk membrane piece faces the space between the upper cover side plate and the mandrel communicating piece.

According to one embodiment of the invention, the mandrel communicating piece comprises a communicating side plate, a breathable film bearing frame and a breathable film; the communicating side plate is arranged on the upper cover bottom plate and communicated with the outer wall of the upper cover bottom plate; the breathable film bearing frame is arranged in the communicating side plate and is positioned above the blood inlet pipe; the ventilated membrane is arranged on the ventilated membrane bearing frame.

According to an embodiment of the invention, the spindle member comprises a spindle body and a flow conductor; the flow guide body is sleeved outside the mandrel body; the blood inlet pipe is communicated with the space between the mandrel body and the flow guide body.

According to one embodiment of the invention, the mandrel body comprises a first end and a second end connected to the first end; the second end is located the below of first end, and the diameter of second end is greater than the diameter of first end, and the first end has the water conservancy diversion cambered surface, and the space between water conservancy diversion cambered surface and the baffle communicates in advancing the blood vessel.

According to an embodiment of the present invention, the flow guiding body includes a flow guiding plate and a plurality of flow guiding holes; the guide plate is sleeved outside the mandrel, and the guide holes are uniformly distributed on the guide plate.

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

According to an embodiment of the present invention, each of the oxygenated filament membrane structures comprises a first fiber layer and a second fiber layer disposed adjacent to each other; 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 crossed mode to form a plurality of silk film pores; along the radial direction of the oxygenation shell, the area of the pores of the silk membrane from the inside to the outside gradually becomes smaller.

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

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

The beneficial effect of this application lies in: the density of the pores of the silk membrane in the unit area of the oxygenation silk membrane structure from inside to outside is gradually increased, so that the density of the pores of the oxygenation silk membrane structure close to the outside is greater than the density of the pores of the oxygenation silk membrane structure close to the inside, the resistance of the oxygenation silk membrane structure close to the inside to blood is smaller than the resistance of the oxygenation silk membrane structure close to the outside to blood, the blood can smoothly and smoothly pass through the oxygenation silk membrane structure close to the inside under the condition of low pressure drop, then enter the oxygenation silk membrane structure close to the outside, and further the blood guided out by the mandrel member is subjected to blood oxygenation exchange mainly by the oxygenation silk membrane structure close to the inside with smaller resistance and subjected to outflow circulation by the oxygenation membrane structure close to the outside, so that the oxygenation exchange efficiency of the blood is considered, and the whole exchange circulation of the blood can be smoothly completed under the condition of low pressure drop; hollow fiber membranes made with poly-4-methyl-1-pentene (PMP) have better oxygen flux and support longer blood circulation cycles.

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 embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. In the drawings:

FIG. 1 is a schematic structural view of an artificial membrane lung for pump-less ECMO in the present embodiment;

FIG. 2 is an exploded view of an artificial membrane lung for pump-less ECMO according to the present embodiment;

FIG. 3 is a sectional view of an artificial membrane lung for pump-less ECMO according to the present embodiment;

FIG. 4 is a schematic structural view of a mandrel body according to the present embodiment;

fig. 5 is a schematic structural diagram of the flow conductor in the present embodiment;

FIG. 6 is a schematic structural view of the structure of the oxygenated filament membrane in the present embodiment;

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

Detailed Description

In the following description, for purposes of explanation, numerous implementation details are set forth in order to provide a thorough understanding of various embodiments of the present invention. It should be understood, however, that these implementation details should not be taken to limit the invention. That is, in some embodiments of the invention, such implementation details are not necessary. In addition, some conventional structures and components are shown in simplified schematic form in the drawings.

It should be noted that all the directional indicators in the embodiment of the present invention, such as up, down, left, right, front, and back … …, are only used to explain the relative position relationship between the components, the motion situation, etc. in a specific posture as shown in the drawing, if the specific posture is changed, the directional indicator is changed accordingly.

In addition, the descriptions related to the first, the second, etc. in the present invention are only used for description purposes, do not particularly refer to an order or sequence, and do not limit the present invention, but only distinguish components or operations described in the same technical terms, and are not understood to indicate or imply relative importance or implicitly indicate the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the feature. In addition, technical solutions between the embodiments may be combined with each other, but must be based on the realization of the technical solutions by a person skilled in the art, and when the technical solutions are contradictory to each other or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

For further understanding of the contents, features and effects of the present invention, the following embodiments are enumerated in conjunction with the accompanying drawings, and the following detailed description is given:

referring to fig. 1 to 3, fig. 1 is a schematic structural view of an artificial membrane lung for pump-less ECMO in the present embodiment, fig. 2 is an exploded view of the artificial membrane lung for pump-less ECMO in the present embodiment, and fig. 3 is a sectional view of the artificial membrane lung for pump-less ECMO in the present embodiment. The pump-less type ECMO artificial membrane lung in this embodiment includes a lower cap 1, an oxygenating portion 2, and an upper cap 3. The lower cover 1 includes an outlet duct 11. The oxygenation section 2 is provided in the lower cover 1. The oxygenation section 2 includes a core shaft member 21, an oxygenation filament membrane member 22, and an oxygenation housing 23. The oxygenation housing 23 is sleeved outside the mandrel member 21, and the oxygenation filament membrane member 22 is located between the mandrel member 21 and the oxygenation housing 23. The oxygenated filament membrane 22 comprises a plurality of oxygenated filament membrane structures 221, the oxygenated filament membrane structures 221 are sequentially sleeved along the radial direction of the oxygenated housing 23, and the density of the filament membrane pores in the unit area of the oxygenated filament membrane structures 221 from inside to outside is gradually increased. The oxygenation housing 23 is provided with a blood outlet tube 231, the blood outlet tube 231 being close to the lower cap 1. The upper cover 3 is provided in the oxygenation section 2. The upper cover 3 includes an intake duct 31 and an intake duct 32. The blood inlet tube 31 communicates with the stem 21, and the air inlet tube 32 communicates with the space between the stem 21 and the oxygenation housing 23.

The density of the pores of the inner filament membrane in the unit area of the inner oxygenation filament membrane structure 221 is gradually increased from inside to outside, so that the density of the pores of the outer oxygenation filament membrane structure 221 close to the outside is greater than the density of the pores of the inner oxygenation filament membrane structure 221 close to the inside, and therefore the resistance of the oxygenation filament membrane structure 221 close to the inside to blood is less than the resistance of the oxygenation filament membrane structure 221 close to the outside to blood, blood can smoothly and smoothly pass through the oxygenation filament membrane structure 221 close to the inside under the condition of low pressure drop, then enter the oxygenation filament membrane structure 221 close to the outside, and further blood guided out by the mandrel member 21 is subjected to blood oxygenation exchange mainly by the oxygenation filament membrane structure 221 close to the inside with small resistance, and then is subjected to outflow circulation by the oxygenation membrane structure 221 close to the outside, so that the oxygenation exchange efficiency of blood is considered, and the whole exchange circulation of blood can be smoothly completed under the condition of low pressure drop.

Referring back to fig. 1 to 3, further, the lower cover 1 further includes a lower cover bottom plate 12, a lower cover side plate 13, and a mandrel support 14. The mandrel support 14 is disposed on the bottom cover 12, and the bottom cover side plate 13 is disposed on the bottom cover 12 and sleeved outside the mandrel support 14. The air outlet pipe 11 is arranged on the bottom plate 12 of the lower cover and communicated with the space between the side plate 13 of the lower cover and the mandrel support 14. The mandrel member 21 is disposed on the mandrel support member 14, the oxygenation housing 23 is disposed on the lower cover side plate 13, and the lower end of the oxygenation silk 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 disc-shaped. The lower cover side plate 13 is a hollow cylindrical shape, is provided on the upper surface of the lower cover bottom plate 12, and is formed into a cover shape in a manner similar to the lower cover bottom plate 12. The mandrel support 14 is a hollow cylindrical member provided on the upper surface of the lower cover bottom plate 12, and has a central axis overlapping with a 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. The outlet pipe 11 is provided on the lower surface of the lower cover bottom plate 12 and communicates with the annular space between the lower cover side plate 13 and the mandrel supporter 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 along the periphery of the lower cover side plate 13 at intervals, and the plurality of lower clamping grooves 131 are used for stably supporting the oxygenation housing 23. The lower cover 1 can also be provided with a lower blocking structure (not shown in the figure) connected with the lower end of the oxygen-containing silk membrane 22 in a centrifugal glue filling mode and other modes, so as to be used for blocking blood in the oxygen-containing silk membrane 22 from moving into the lower cover 1, and the existing blocking structure is adopted in practical application, and the details are not repeated here.

Referring to fig. 3 again, the lower cover bottom plate 12 is disposed obliquely such that one side of the lower cover bottom plate 12 is close to the lower end of the oxygen-doped fiber membrane 22, the other side of the lower cover bottom plate 12 is far from the lower end of the oxygen-doped fiber membrane 22, and the air outlet pipe 11 is disposed on one side of the lower cover bottom plate 12 which is far from the lower end of the oxygen-doped fiber membrane 22. In this way, the annular space between the lower cover side plate 13 and the mandrel support 14 is formed into a deeper part and a shallower part, and the 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 as to facilitate the collection and discharge of exchanged gas.

Preferably, a lower reinforcing plate 14 is further disposed on a surface of the lower cover bottom plate 12 facing away from the lower cover side plate 13. The strength of the lower cover 1 is enhanced by the provision of the lower reinforcement plate 14.

Referring to fig. 4 and 5, fig. 4 is a schematic structural view of the mandrel body in the present embodiment, and fig. 5 is a schematic structural view of the flow guiding body in the present embodiment. Further, the core shaft 21 includes a core shaft body 211 and a current carrier 212. The current carrier 212 is disposed outside the mandrel body 211. The blood inlet tube 31 communicates with the space between the stem body 211 and the flow conductor 212. The mandrel body 211 includes a first end 2111 and a second end 2112 connected to the first end 2111. Second end 2112 is positioned below first end 2111, second end 2112 having a diameter greater than first end 2111, and first end 2111 having a flow directing arc 21111. The space between the diversion arc surface 21111 and the diversion body 212 is communicated with the blood inlet pipe 31. Specifically, the first end portion 2111 is cylindrical, and the diameter of the first end portion 2111 gradually increases from the upper end of the first end portion 2111 to the lower end of the first end portion 2111, so that the outer wall of the first end portion 2111 forms a flow guiding arc surface 21111. The second end portion 2112 is cylindrical, and its upper end is integrally formed with the lower end of the first end portion 2111. The lower end of second end 2112 is connected to the lower end of current carrier 212. Thus, a blood channel is formed between the core shaft body 211 and the flow guiding body 212, and blood entering from the blood inlet tube 31 is uniformly distributed toward the flow guiding body 212 through the flow guiding arc surface 21111 of the first end portion 2111, and then is guided to the outer oxygenated filament membrane 22 by the flow guiding body 212.

The flow guide body 212 includes a flow guide plate 2121 and a plurality of flow guide holes 2122. The guide plate 2121 is sleeved outside the spindle body 211, and a plurality of guide holes 2122 are uniformly distributed on the guide plate 2121. The deflector 2121 is hollow and cylindrical, and is sleeved outside the mandrel body 211, and the deflector 2121 is disposed on the mandrel support 14. A blood passage is formed between the spool body 211 and the baffle 2121, and the lower end of the baffle 2121 is connected to the lower end of the second end 2112. Preferably, current carrier 212 also includes a plurality of helical current carriers 2123. Each of the spiral guide grooves 2123 is disposed on the inner wall of the guide plate 2121 along the height direction of the guide plate 2121, and a plurality of the spiral guide grooves 2123 are sequentially arranged at intervals along the circumferential direction of the guide plate 2121. The plurality of guiding holes 2122 are sequentially arranged in the spiral guiding groove 2123 at intervals from top to bottom. Preferably, the aperture of the flow guide holes 2122 gradually increases from the side close to the inner wall of the flow guide plate 2121 to the side of the outer wall of the flow guide plate 2121, so that the flow guide holes 2122 are approximately trumpet-shaped. By the cooperation of the spiral guiding grooves 2123 and the guiding holes 2122 and the assistance of the trumpet-shaped guiding holes 2122, the blood in the blood channel can be smoothly and smoothly guided to the oxygenated filament membrane 22 under the condition of low pressure drop, and the flow distribution is uniform. The upper and lower ends of the flow guide plate 2121 are provided with bearing clamping grooves 21211, and annular grooves of the bearing clamping grooves 21211 are annularly arranged on the end surfaces of the upper and lower ends of the flow guide plate 2121. The lower end of the deflector 2121 bears a catch 21211 which is engaged with the upper end of the mandrel support 14.

Referring to fig. 6, fig. 6 is a schematic structural view of the structure of the oxygenated filament membrane in this embodiment. Furthermore, a plurality of the oxygenated filament membrane structures 221, which are sequentially sleeved from inside to outside, are hollow cylindrical, and the lower ends of the oxygenated filament membrane structures face the lower cover side plate 13 and form an annular space with the mandrel support 14. Each of the oxygenated filament membrane structures 221 includes a first fiber layer 2211 and a second fiber layer 2212 disposed adjacent to each other. 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 plurality of first fiber tubes 22111 and the plurality of second fiber tubes 22121 are respectively arranged to intersect with each other to form a plurality of filament film apertures 2213. The area of the inner-to-outer silk membrane apertures 2213 gradually becomes smaller along the radial direction of the oxygenation housing 23. Preferably, the silk film apertures 2213 are diamond shaped. The material from which the first fiber tubes 22111 and/or the second fiber tubes 22121 are made is poly-4-methyl-1-pentene (PMP).

Specifically, the first fiber tubes 22111 are arranged at intervals in the circumferential direction, and each of the first fiber tubes 22111 is disposed obliquely, specifically, obliquely from the axial direction of the oxygenation housing 23 to the direction away from the axial direction, so that the first fiber tubes 22111 form an oblique included angle with the central axis of the oxygenation housing 23, and the oblique included angle of the first fiber tubes 22111 in this embodiment is 10 to 20 degrees, preferably 15 degrees. The second fiber tubes 22121 are arranged in the same manner as the first fiber tubes 22111, except that the second fiber tubes 22121 are inclined in the opposite direction to the first fiber tubes 22111, so that the first fiber tubes 22111 and the second fiber tubes 22121 are crossed, and the crossed first fiber tubes 22111 and the second fiber tubes 22121 form diamond-shaped wire film pores 2213.

In this embodiment, the density of the silk film apertures 2213 in a unit area, i.e. the number of the silk film apertures 2213 in a unit area, is greater when the number of the silk film apertures 2213 in a unit area is greater, and is less when the number is greater. For example, the hollow cylindrical oxygenated filament membrane structure 221 is rectangular after being spread, and the greater the number of filament membrane pores 2213 in the rectangular plane, the denser, that is, the greater the degree of density. As the number of silk film apertures 2213 per unit area is greater, the area of a single silk film aperture 2213 is smaller. That is, along the radial direction of the oxygenation housing 23, the density of the filament film apertures 2213 in a unit area gradually becomes larger, and the area of the filament film apertures 2213 gradually becomes smaller. The greater the density of the silk film apertures 2213, the greater the resistance to blood flow, and conversely, the less the density of the silk film apertures 2213, the lower the resistance to blood flow. In this embodiment, the density of the pores of the outer membrane 221 per unit area is less than the density of the pores of the outer membrane 221 per unit area, so that blood can smoothly pass through the inner side under low pressure drop. Compared with the consistent density of the pores of the inner silk membrane in unit area of the outer oxygenation silk membrane structure 221 on the inner side and the outer side, the blood pressure drop required by the blood passing is lower. In other words, the blood guided out from the guiding holes 2122 passes through the oxygenation filament membrane 22 from inside to outside along the radial direction of the oxygenation housing 23, that is, passes through the plurality of oxygenation filament membrane structures 221 from inside to outside, and the area of the filament membrane aperture 2213 through which the blood passes gradually decreases, that is, the blocking pressure of the oxygenation filament membrane structure 221 closer to the inside against the blood decreases, so that the blood can smoothly pass through the oxygenation filament membrane structure 221 closer to the inside under the condition of low pressure drop to complete the main blood exchange function, and then passes through the oxygenation filament membrane structure 221 closer to the outside and flows out from the blood outlet pipe 231 of the oxygenation housing 23, thereby ensuring that the blood smoothly completes the exchange cycle under the condition of low pressure drop while considering the blood exchange efficiency. Both the first fiber tube 22111 and the second fiber tube 22121 in this embodiment are hollow fiber tubes.

Referring to fig. 1 to 3, the oxygenation housing 23 is hollow and cylindrical, and has a plurality of lower stoppers 232 at a lower end thereof and a plurality of upper stoppers 233 at an upper end thereof. The plurality of lower latch 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 latch 233 are disposed on the outer wall of the oxygenation housing 23 along the circumferential direction of the oxygenation housing 23. The lower latch 232 is matched with the lower latch groove 131. During assembly, the lower end of the oxygenation casing 23 is arranged in the lower cover side plate 13, and the plurality of lower clamping blocks 232 are respectively clamped in the plurality of lower clamping grooves 233 in a matching manner. The blood outlet pipe 231 is vertically arranged on the outer wall of the oxygenation housing 23 and communicated with the inner wall of the oxygenation housing 23. The blood outlet 231 is adjacent to the lower cover side plate 13. Preferably, the outer wall of the oxygenation housing 23 is further provided with a circulation exhaust pipe 234, and the circulation exhaust pipe 234 is positioned above the blood outlet pipe 231 and close to the upper cover 3. The circulation exhaust pipe 234 is connected to the inner wall of the oxygenation housing 23, so that the space between the stem member 21 and the oxygenation housing 23 is connected to the circulation exhaust pipe 234, and the blood flowing in the oxygenation part 2 and possibly generated gas floating during oxygenation can be exhausted from the circulation exhaust pipe 234.

Preferably, the oxygenation part 2 further comprises an outer baffle 24. The outer flow guide member 24 is a hollow cylinder, and is located in the oxygenation housing 23 and sleeved outside the oxygenation filament membrane member 22. A plurality of outer guiding holes 241 are uniformly distributed on the outer guiding element 24. The utilization rate of the oxidized silk film piece 22 is enhanced through the outer guide holes 241 of the outer guide piece 24. Preferably, the outer wall of the outer baffle 24 is provided with a plurality of outer guide grooves 242, each outer guide groove 242 is arranged along the height direction of the outer baffle 24, and the plurality of outer guide grooves 242 are sequentially arranged along the periphery of the outer baffle 24. The plurality of outer guide holes 241 are sequentially arranged along the height direction of the outer guide grooves 242. Preferably, the aperture of the outer flow guiding hole 241 is gradually increased from the inner wall close to the outer flow guiding member 24 to the outer wall close to the outer flow guiding member 24, so that the outer flow guiding hole 241 is approximately trumpet-shaped. Thus, the fluency of the blood circulation can be increased.

Referring to fig. 7, fig. 7 is a schematic structural diagram of the upper cover in this embodiment. Further, the upper cover 3 further includes an upper cover bottom plate 33, an upper cover side plate 34, and a spindle communication member 35. The spindle communicating 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 blood inlet tube 31 communicates with the mandrel communicating member 35, and the air inlet tube 32 communicates with a space between the upper cover side plate 34 and the mandrel communicating member 35. The upper cover side plate 34 is connected with the oxygenating housing 23, and the upper end of the oxygenating filament membrane 22 faces the space between the upper cover side plate 34 and the mandrel communicating member 35.

Specifically, the upper cover bottom plate 33 has a disk shape. The upper cover side plate 34 is a hollow cylindrical shape, is perpendicular to the lower surface of the upper cover bottom plate 33, and is formed into a cover shape in cooperation with the upper cover bottom plate 33. The mandrel communication member 35 includes a communication side plate 351, a vented membrane carrier 352, and a vented membrane (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 vented membrane holder 352 is disposed within the communication side plate 351 and above the blood inlet vessel 31. The vented membrane is provided to the vented membrane carrier 352. The communication side plate 351 includes a first through tube 3511 and a second through tube 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. In this embodiment, the first through tube 3511 and the second through tube 3512 are both hollow cylinders, and the diameter of the first through tube 3511 is larger than that of the second through tube 3512. Preferably, the midline axes of the first through barrel 3511, the second through barrel 3512 and the upper cover side plate 34 overlap. The first through tube 3511 and the upper cover side plate 34 form an annular space. The vented membrane carrier 352 is disposed within the first through-tube 3511 and is proximate to the upper cover bottom panel 33. The vented membrane is provided to the vented membrane carrier 352. The blood inlet tube 31 passes through the upper cover side plate 34 and then is communicated with the first through tube 3511. The intake duct 32 communicates with an annular space between the upper cover side plate 34 and the first barrel 3511. A plurality of upper clamping grooves 341 are formed in the upper cover side plate 34 along the circumferential direction of the upper cover side plate, the upper clamping grooves 341 are sequentially arranged at intervals, and the upper clamping grooves 341 are matched with the upper clamping blocks 233. During assembly, the upper end of the oxygenation housing 23 is arranged in the upper cover side plate 34, and the plurality of upper clamping blocks 233 are respectively clamped in the plurality of upper clamping grooves 341 in a matching manner. The first through tube 3511 is opposite to and clamped in a bearing clamping groove 21211 at the upper end of the guide plate 2121. The annular space between the upper cover side plate 34 and the first barrel 3511 is aligned with the upper end of the oxidized silk film material 22. Preferably, an upper reinforcing plate 36 is further disposed on a side of the upper cover bottom plate 33 opposite to the upper cover side plate 34. 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) connected with the upper end of the oxygenated membrane 22 in a centrifugal glue filling manner and the like for blocking blood in the oxygenated membrane 22 from moving into the upper cover 3, and the existing blocking structure is adopted in practical application, which is not described herein again.

The blood circulation process in this example is as follows: blood in a human body enters the first through tube 3511 from the blood inlet tube 31 to form a blood vortex, the gas is separated by centrifugal force generated by the vortex and then discharged through the gas permeable membrane, the blood falls into a blood channel formed between the core shaft body 211 and the flow guide plate 2121, and then is shunted to the oxygenation filament membrane element 22 through the flow guide holes 2122, the oxygenation filament membrane structure 221 close to the inner side diffuses towards the oxygenation filament membrane structure 221 close to the outer side, the blood is oxygenated in the oxygenation filament membrane structure 221 and carbon dioxide is removed, the oxygenated blood circulates to the human body through the blood outlet tube 231, and the removed carbon dioxide gas is discharged from the air outlet tube 11.

In summary, the pump-free ECMO artificial membrane lung in this embodiment has both blood exchange efficiency and ensures that the blood can smoothly complete exchange cycle under low pressure drop, and the hollow fiber membrane made of poly-4-methyl-1-pentene (PMP) has better oxygen flux and supports longer blood circulation cycle.

The above is merely an embodiment of the present invention, and is not intended to limit the present invention. Various modifications and alterations to this invention will become apparent to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A pumpless artificial membrane lung for ECMO, comprising:

the lower cover comprises an air outlet pipe;

the oxygenation part is arranged on the lower cover and comprises a mandrel part, an oxygenation filament membrane part and an oxygenation shell; the mandrel component comprises a mandrel body and a flow guide body; the flow guide body is sleeved outside the mandrel body; the oxygenation shell is sleeved outside the flow guide piece, and the oxygenation silk membrane piece is positioned between the flow guide body and the oxygenation shell; the oxygenation silk membrane piece comprises a plurality of oxygenation silk membrane structures, the oxygenation silk membrane structures are sequentially sleeved along the radial direction of the oxygenation shell, and the density of the silk membrane pores in the unit area of the oxygenation silk membrane structure is gradually increased from inside to outside; the oxygenation housing is provided with a blood outlet pipe which is close to the lower cover; and

an upper cover arranged on the oxygenation part; the upper cover comprises a blood inlet pipe and an air inlet pipe; the air inlet pipe is communicated with a space between the mandrel body and the flow guide body, and the air inlet pipe is communicated with a space between the mandrel body and the oxygenation shell;

the flow guide body comprises a flow guide plate and a plurality of flow guide holes; the guide plate is sleeved outside the mandrel, and the plurality of guide holes are uniformly distributed in the guide plate; the flow guide body also comprises a plurality of spiral flow guide grooves; each spiral flow guide groove is arranged on the inner wall of the flow guide plate along the height direction of the flow guide plate, and the spiral flow guide grooves are sequentially arranged at intervals along the peripheral direction of the flow guide plate; the plurality of flow guide holes are sequentially arranged in the spiral flow guide groove at intervals from top to bottom; the aperture of the guide hole is gradually increased from one side close to the inner wall of the guide plate to one side of the outer wall of the guide plate;

each oxygenated silk membrane 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 tubes, the second fiber layer is provided with a plurality of second fiber tubes, and the first fiber tubes and the second fiber tubes are respectively arranged in a mutually crossed mode to form a plurality of silk film pores; along the radial direction of the oxygenation shell, the area of the silk membrane pores gradually becomes smaller from inside to outside;

oxygenation portion still includes outer water conservancy diversion spare, outer water conservancy diversion spare is located the oxygenation casing, and outside the oxygen silk membrane spare was located to the cover, the equipartition has a plurality of outer water conservancy diversion holes on the outer water conservancy diversion spare, the outer wall of outer water conservancy diversion spare sets up a plurality of outer guiding gutters, each outer guiding gutter sets up along the direction of height of outer water conservancy diversion spare, a plurality of outer guiding gutters are arranged along the periphery of outer water conservancy diversion spare in proper order, a plurality of outer water conservancy diversion holes set gradually along the direction of height of outer guiding gutter, the aperture in outer water conservancy diversion hole is by being close to outer water conservancy diversion spare inner wall towards the direction grow gradually of being close to outer water conservancy diversion spare outer wall.

2. The artificial membrane lung for pump-less ECMO according to claim 1, wherein the lower cover further comprises a lower cover bottom plate, a lower cover side plate, and a mandrel support; the mandrel supporting piece is arranged on the lower cover bottom plate, and the lower cover side plate is arranged on the lower cover bottom plate and sleeved outside the mandrel supporting piece; the air outlet pipe is arranged on the lower cover bottom plate and communicated with a space between the lower cover side plate and the mandrel support piece; the core shaft piece is arranged on the core shaft support piece, the oxygenation shell is arranged on the lower cover side plate, and the lower end of the oxygenation silk film piece faces to a space between the lower cover side plate and the core shaft support piece.

3. The artificial membrane lung for pumpless ECMO of claim 1, wherein the upper cover further comprises an upper cover bottom plate, an upper cover side plate, and a mandrel communicating member; the mandrel communicating piece is arranged on the upper cover bottom plate and communicated with the mandrel piece; the upper cover side plate is arranged on the upper cover bottom plate and sleeved outside the mandrel communicating piece; the air inlet pipe is communicated with the mandrel communicating piece, and the air inlet pipe is communicated with a space between the upper cover side plate and the mandrel communicating piece; the upper cover side plate is connected with the oxygenation shell, and the upper end face of the oxygenation silk membrane piece faces to a space between the upper cover side plate and the mandrel communicating piece.

4. The artificial membrane lung for pumpless ECMO according to claim 3, wherein the mandrel communication member includes a communication side plate, a breathable membrane carrier, and a breathable membrane; the communicating side plate is arranged on the upper cover bottom plate and communicated with the outer wall of the upper cover bottom plate; the breathable film bearing frame is arranged in the communicating side plate and is positioned above the blood inlet pipe; the ventilated membrane is arranged on the ventilated membrane bearing frame.

5. The artificial membrane lung for pump-less ECMO according to claim 1, wherein the mandrel body comprises a first end and a second end connected to 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, the first end part is provided with a flow guide arc surface, and a space between the flow guide arc surface and the flow guide body is communicated with the blood inlet pipe.

6. The artificial membrane lung for pumpless ECMO of claim 1, wherein the silk film pores are diamond-shaped.

7. The artificial membrane lung for pumpless ECMO of claim 1, wherein a material of the first fiber tube and/or the second fiber tube is poly-4-methyl-1-pentene (PMP).