Oxygenator

Abstract

A first chamber and a second chamber are formed between the two ends, in the first direction, of a medium exchange module and a shell, a gas inflow cavity and a heat medium inflow cavity are formed between one end, in the second direction, of the medium exchange module and the shell, and a gas outflow cavity and a heat medium outflow cavity are formed between the other end and the shell. Two ends of the first / third gas exchange pad are respectively communicated with the first and second chambers, two ends of the second gas exchange pad are respectively communicated with the gas inflow / outflow cavity, and two ends of the heat exchange pad are respectively communicated with the heat medium inflow / outflow cavity. The first cavity is communicated with the gas inflow cavity, the second cavity is communicated with the gas outlet, the gas inflow cavity is communicated with the gas inlet, the thermal medium inflow cavity is communicated with the thermal medium inlet, and the thermal medium outflow cavity is communicated with the thermal medium outlet.

Description

Technical Field

[0001] The present invention relates to oxygenators. Background Art

[0002] Compared with traditional membrane oxygenators whose exchange pads are wound, the exchange pads of stacked membrane oxygenators adopt a criss-cross overlapping design, which has the advantages of shorter blood flow path, larger cross-section, more uniform blood distribution, and lower transmembrane pressure difference. This can greatly extend the clinical use time and is more suitable for long-term extracorporeal circulation support.

[0003] In the first known embodiment of an oxygenator, such as those in US Pat. No. 5,162,101A and CN115,192,807B, etc., the stacked gas exchange pads and heat exchange pads are located in two separate chambers. All hollow fiber tubes of the same exchange pad are oriented in the same direction, and both types of pads are also oriented in the same direction. Based on this, oxygenators such as those in CN113,350,596A and CN117,339,043B have developed a new stacking method for the exchange pads, namely, all hollow fiber tubes of the same exchange pad are layered and oriented perpendicularly. However, this design still maintains the traditional design of two independent exchange pads located in two chambers. This arrangement offers the advantage of relative independence between the two exchange pads, preventing interference between the gas and heat medium. The gas and heat medium flow paths are relatively pure, resulting in a simpler flow path structure.

[0004] In a second known oxygenator embodiment, as exemplified by CN107929839A, CN113144317A, and CN116999637A, the exchange pad in one chamber is still solely a gas exchange pad, while the exchange pad in the other chamber is a hybrid membrane composed of a vertically oriented gas exchange pad and a heat exchange pad. Blood first passes through the hybrid membrane, where it is heated and partially oxygenated, before passing through the gas exchange pad for further oxygenation, thereby improving oxygenation efficiency. This arrangement of exchange pads requires that gas must flow through the gas exchange pads in both chambers simultaneously, but cannot flow through the heat exchange pad in the same chamber as the gas exchange pad. Furthermore, the heat medium must flow only through the heat exchange pad, not through the gas exchange pad in the same chamber, to prevent the hollow fiber tubes of the gas exchange pad from becoming blocked and ineffective. Therefore, a corresponding structure is required to achieve the aforementioned flow path. However, the aforementioned known embodiments do not provide such an implementation. Although US1 0201649B2, CN116271306B, and others provide solutions for allowing gas to flow through vertically oriented gas exchange pads, this is done without a heat exchange pad, and the flow channel design is clearly easy to implement. EP4426369A1, GB2574015A, and others, even without a heat exchange pad, achieve a gas flow channel by providing two or even multiple groups of gas inlets and outlets, which obviously complicates the gas path structure. JP7190201B2 discloses a solution for achieving the above-mentioned flow channel in a stacked membrane oxygenator, by stacking a gas exchange pad and a heat exchange pad to form a unit, with multiple such units arranged along the direction of blood flow. Furthermore, in each unit, the length of the gas exchange pad is greater than that of the heat exchange pad, so that both ends of the hollow fiber tube of the gas exchange pad communicate with the gas cavity of the housing, and both ends of the hollow fiber tube of the heat exchange pad communicate with the heat medium cavity of the housing, with the two chambers separated by a partition wall. However, this implementation is still applicable to the stacked membrane oxygenator of the first known embodiment, while the flow channel design of the stacked membrane oxygenator of the second known embodiment with higher oxygenation efficiency still needs to be realized. Summary of the Invention

[0005] The present invention provides an oxygenator suitable for a laminated membrane design including a pure gas exchange pad and a mixed membrane composed of a gas exchange pad and a heat exchange pad, and is used to solve at least one of the following technical problems:

[0006] 1. Only one set of gas inlet and outlet is required to supply gas to two sets of gas exchange pads at the same time.

[0007] 2. The heat medium can only flow through the heat exchange pad, but not through the gas exchange pad, so as to avoid the hollow fiber tube of the gas exchange pad being blocked and failing.

[0008] To achieve the above objectives, the present invention provides the following solutions.

[0009] The oxygenator includes a housing and a medium exchange module disposed in the housing. The housing is generally square and has first, second, and third directions perpendicular to each other. The medium exchange module includes a mixing exchange unit and a gas exchange unit. The mixing exchange unit includes a first gas exchange pad and a heat exchange pad stacked along the third direction. The hollow fiber tubes of the first gas exchange pad extend along the first direction, and the hollow fiber tubes of the heat exchange pad extend along the second direction. The gas exchange unit includes second and third gas exchange pads stacked along the third direction. The hollow fiber tubes of the second gas exchange pad extend along the second direction, and the hollow fiber tubes of the third gas exchange pad extend along the first direction. Blood enters the housing through the blood inlet, passes through the medium exchange module along the third direction to achieve oxygenation, and flows out from the blood outlet.

[0010] In one embodiment, a first chamber and a second chamber are formed between the two ends of the medium exchange module along the first direction and the inner wall of the shell. A gas inlet chamber and a heat medium inlet chamber are formed between one end of the medium exchange module along the second direction and the inner wall of the shell, and a gas outflow chamber and a heat medium outflow chamber are formed between the other end and the inner wall of the shell. Both ends of the hollow fiber tubes of the first / third gas exchange pads are connected to the first and second chambers, respectively. Both ends of the hollow fiber tubes of the second gas exchange pads are connected to the gas inlet chamber and the gas outflow chamber, respectively. Both ends of the hollow fiber tubes of the heat exchange pads are connected to the heat medium inlet chamber and the heat medium outflow chamber, respectively. The first chamber is connected to the gas inlet chamber, and the gas inlet is connected to at least one of the first chamber and the gas inlet chamber. The second chamber is connected to the gas outflow chamber, and the gas outlet is connected to at least one of the second chamber and the gas outflow chamber. The heat medium inlet chamber is connected to the heat medium inlet, and the heat medium outflow chamber is connected to the heat medium outlet.

[0011] In another embodiment, the heat medium inflow cavity and the heat medium outflow cavity are sealed and isolated from the hollow fiber tubes of the first, second, and third gas exchange pads. A heat medium inflow compartment and a heat medium outflow compartment are provided on the inner wall of the housing. The heat medium inflow compartment connects the heat medium inlet to the heat medium inflow cavity, and the heat medium outflow compartment connects the heat medium outlet to the heat medium outflow cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a perspective view of the oxygenator according to an embodiment of the present invention from the front side;

[0013] Figure 2 is a perspective view of the rear side of an oxygenator according to an embodiment of the present invention;

[0014] Figure 3 for Figure 1 a front view of the oxygenator shown;

[0015] Figure 4 for Figure 1 and Figure 2 An internal outline of the oxygenator shown;

[0016] Figure 5 for Figure 1 and Figure 2 A perspective exploded view of the oxygenator shown;

[0017] Figure 6 for Figure 1 Stereoscopic view of the section at AA;

[0018] Figure 7 for Figure 1 A three-dimensional view of the cross section at the middle BB;

[0019] Figure 8 is a bottom-up stereogram of the first shell;

[0020] Figure 9 is a top perspective view of the second shell;

[0021] Figure 10 is a three-dimensional cross-sectional view of the third shell;

[0022] Figure 11 A simplified schematic diagram of the media exchange module. DETAILED DESCRIPTION

[0023] Referring to the descriptions in CN116747368A and CN118001064B, the oxygenator 100 of this embodiment can be secured to a support frame on the back of the control unit via a connection assembly 70 located at its bottom. In this state, the oxygenator 100 is in operation, with the heat medium inlet 131 and heat medium outlet 133 pointing obliquely downward, and the blood inlet 151 and blood outlet 161 pointing obliquely upward.

[0024] For the convenience of explanation, the posture of the oxygenator 100 is adjusted so that the heat medium inlet 131 and the heat medium outlet 133 on the same side are approximately horizontal and the blood inlet 151 faces the viewing angle, as shown in FIG. Figure 3 As shown. In this case, the first, second, and third directions L1, L2, and L3 of the square housing 10 are perpendicular to each other and are the horizontal, vertical, and front-to-back directions, respectively. The horizontal and vertical directions define the horizontal and vertical lengths of the housing 10, while the front-to-back direction defines the thickness of the housing 10. The horizontal and vertical lengths of the housing 10 are equal and greater than the thickness.

[0025] The terms "front", "back", "left", and "right" are used by users to Figure 3When viewing the oxygenator 100 from the perspective shown, "front" refers to the direction relatively close to the user, "rear" refers to the direction relatively far from the user, "left" refers to the user's left-hand side, and "right" refers to the user's right-hand side. For example, the gas inlet 112 is located at the upper end or top of the housing 10, the connection assembly 70 is located at the lower end or bottom of the housing 10, the blood inlet 151 is located at the front side of the housing 10, the blood outlet 161 is located at the rear side of the housing 10, and the heat medium inlet 131 and heat medium outlet 133 are located on the right side of the housing 10.

[0026] like Figures 1 to 5 As shown, the housing 10 includes four circumferentially connected shells: a first shell 11, a second shell 12, a third shell 13, and a fourth shell 14, which are arranged opposite each other, and two opposite cover plates: a front cover plate 15 and a rear cover plate 16. The media exchange module 60 has a similar shape to the housing 10 (a square hexahedron) and has six end faces: a first end 601 and a second end 602, a third end 603 and a fourth end 604, and a fifth end 605 and a sixth end 606. The first shell 11, the second shell 12, the third shell 13, the fourth shell 14, the front cover plate 15, and the rear cover plate 16 are located outside the first end 601, the second end 602, the third end 603, the fourth end 604, the fifth end 605, and the sixth end 606 of the media exchange module 60, respectively. The first end 601 and the second end 602 are the two ends of the medium exchange module 60 along the second direction L2, the third end 603 and the fourth end 604 are the two ends of the medium exchange module 60 along the first direction L1, and the fifth end 605 and the sixth end 606 are the two ends of the medium exchange module 60 along the third direction L3. Figure 3 From a perspective, the first shell 11 is the upper shell, the second shell 12 is the lower shell, the third shell 13 is the right shell, the fourth shell 14 is the left shell, the front cover 15 is the blood inlet plate, and the rear cover 16 is the blood outlet plate. The first end 601 is the upper end, the second end 602 is the lower end, the third end 603 is the right end, the fourth end 604 is the left end, the fifth end 605 is the front end, and the sixth end 606 is the rear end.

[0027] The blood inlet 151 is provided on the front cover 15, the blood outlet 161 is provided on the rear cover 16, and the heat medium inlet 131 and heat medium outlet 133 are provided on the third shell 13. The gas inlet 112 is provided on either the first shell 11 or the fourth shell 14, or at the intersection of the first and fourth shells 11 and 14 (as in US Pat. No. 1,020,1649B2), so that the gas inlet 112 communicates with at least one of the first chamber 141 and the gas inflow chamber 101. Since the first chamber 141 is connected to the gas inflow chamber 101, the gas inlet 112 communicates with at least one of them, enabling simultaneous gas supply to both the first chamber 141 and the gas inflow chamber 101. However, preferably, the gas inlet 112 is provided on the first shell 11 to prevent interference with the support frame during operation of the oxygenator 100. Similarly, the gas outlet 121 is provided on either the second shell 12 or the third shell 13, or at the intersection of the second shell 12 and the third shell 13, so that the gas outlet 121 communicates with at least one of the second chamber 132 and the gas outflow chamber 201. However, preferably, the gas outlet 121 is provided at the bottom of the second shell 12, located behind the connecting assembly 70, and is substantially parallel to the heat medium inlet 131 and the heat medium outlet 133, but avoids being in the same cross-section as the heat medium inlet 131 and the heat medium outlet 133. This can minimize interference with the heat medium pipeline.

[0028] like Figure 5 As shown, the frame 20 provided in the housing 10 includes a generally square frame 21 and columns, the columns including: front side columns 22 extending forward from the four corners of the frame 21, and rear side columns 23 extending rearward from the four corners of the frame 21. The four circumferential shells 11, 12, 13, 14 are snap-fitted to the four sides of the frame 20, the front cover plate 15 is connected to the front side columns 22, and the rear cover plate 16 is connected to the rear side columns 23 (via four positioning columns at the corners of the cover plates 15 and 16 that are respectively plugged into the positioning holes on the four columns 22 and 23 for fixed connection).

[0029] like Figure 4 and Figure 5As shown, the housing 10 is further provided with a partition plate 30 fixed to the square frame 21, a front diverter plate 40 located between the partition plate 30 and the front cover plate 15, and a rear diverter plate 50 located between the partition plate 30 and the rear cover plate 16. The partition plate 30 and the diverter plates 40 and 50 are provided with holes for blood to pass through and to homogenize the blood flow field. A mixing exchange chamber 34 is formed between the partition plate 30 and the front diverter plate 40 to accommodate the mixing exchange unit 61, and a gas exchange chamber 35 is formed between the partition plate 30 and the rear diverter plate 50 to accommodate the gas exchange unit 62. After the mixing exchange unit 61 and the gas exchange unit 62 are prepared (membrane filament stacking → sealing → die cutting), they are respectively placed into the front and rear sides of the frame 20, and then the housing 10 is assembled to complete the production of the oxygenator 100.

[0030] The medium exchange module 60 is formed with a sealing material 63 at its edge by a potting glue and centrifugal process well known in the art. Figure 5 and Figure 11 As shown, after the sealing material 63 is die-cut, the hollow fiber tubes GT of the gas exchange pads 611, 622, and 623 and the hollow fiber tubes HT of the heat exchange pad 612 are flush with the outer end surface of the sealing material 63 to allow gas (oxygen or air-oxygen mixture) or heat medium (warm water at 38 to 42°C) to flow in or out, and allow blood to vertically pass through the gap between the hollow fiber tubes GT and HT of the medium exchange module 60, thereby sealing and isolating the blood flow channel, gas flow channel, and heat medium flow channel. Specifically, the sealing material 63 seals and isolates the hollow fiber tubes GT of the gas exchange pads 611, 622, and 623 from the heat medium flow channels (heat medium inflow chamber 102, heat medium outflow chamber 202, and heat medium inflow compartment 134 and heat medium outflow compartment 135). It also seals and isolates the hollow fiber tubes HT of the heat exchange pad 612 from the gas flow channels (first chamber 141, second chamber 132, gas inflow chamber 101, gas outflow chamber 201, heat medium inflow chamber 102, and heat medium outflow chamber 202). Furthermore, it seals and isolates the mixing exchange chamber 34 and gas exchange chamber 35, which are provided in the medium exchange module 60 and allow blood to pass through, from the surrounding heat medium and gas flow channels. In this way, blood flows only through the gaps between the hollow fiber tubes GT and HT of the medium exchange module 60, gas flows only through the interior of the hollow fiber tubes GT of the gas exchange pads 611, 622, and 623, and the heat medium flows only through the interior of the hollow fiber tubes HT of the heat exchange pad 612. Thus, the flow paths of blood, gas and thermal medium are uniquely defined.

[0031] like Figure 11As shown, the gas exchange unit 62 is a pure gas membrane. The hollow fiber tubes GT of the second gas exchange pad 622 extend in the second direction L2, and the hollow fiber tubes GT of the third gas exchange pad 623 extend in the first direction L1. In the exemplary embodiment, the second gas exchange pad 622 and the third gas exchange pad 623 are stacked in an alternating manner. That is, a layer of GT fiber pad is stacked first, then a layer of GT fiber pad is stacked vertically, then a layer of GT fiber pad is stacked vertically, and so on. The mixed exchange unit 61 is a mixed membrane composed of a first gas exchange pad 611 and a heat exchange pad 612. The hollow fiber tubes GT of the first gas exchange pad 611 extend in the first direction L1, and the hollow fiber tubes HT of the heat exchange pad 612 extend in the second direction L2. In the exemplary embodiment, the first gas exchange pad 611 and the heat exchange pad 612 also adopt the same alternating stacking method as described above. That is, a layer of HT fiber pad is stacked first, then a layer of GT fiber pad is stacked vertically, then a layer of HT fiber pad is stacked vertically, and so on. Alternatively, in other feasible embodiments, the first gas exchange pads 611 and the heat exchange pads 612 are not stacked in an interlaced manner, but rather all of the first gas exchange pads 611 are stacked together to form an air film layer, and all of the heat exchange pads 612 are stacked together to form a heat film layer, and then the two film layers are stacked together in a vertical orientation to form a mixed exchange unit 61. Therefore, the hollow fiber tubes GT of the first gas exchange pad 611 are parallel to the hollow fiber tubes GT of the third gas exchange pad 623, and are oriented in a first direction L1 or horizontally. The hollow fiber tubes GT of the second gas exchange pad 622 are parallel to the hollow fiber tubes HT of the heat exchange pad 612, and are oriented in a second direction L2 or vertically. Furthermore, the hollow fiber tubes GT of the first gas exchange pad 611 and the third gas exchange pad 623 are perpendicular to the hollow fiber tubes GT and HT of the second gas exchange pad 622 and the heat exchange pad 612.

[0032] A first chamber 141 and a second chamber 132 are formed between the outer walls of the medium exchange module 60 at both ends (the third end 603 or the fourth end 604, or the left or right end) along the first direction L1 and the inner wall of the housing 10. A gas inlet chamber 101 and a heat medium inlet chamber 102, which are isolated from each other, are formed between the outer wall of one end (the first end 601 or the upper end) of the medium exchange module 60 along the second direction L2 and the inner wall of the housing 10. A gas outlet chamber 201 and a heat medium outlet chamber 202, which are isolated from each other, are formed between the outer wall of the other end (the second end 602 or the lower end) of the medium exchange module 60 and the inner wall of the housing 10. The upper and lower ends of the hybrid exchange unit 61 correspond to the heat medium inlet chamber 102 and the heat medium outlet chamber 202, respectively, and the upper and lower ends of the gas exchange unit 62 correspond to the gas inlet chamber 101 and the gas outlet chamber 201, respectively. Therefore, the heat medium inflow chamber 102 and the heat medium outflow chamber 202 are essentially defined by the upper and lower ends of the mixing exchange unit 61 and the upper and lower inner walls of the shell 10, and the gas inflow chamber 101 and the gas outflow chamber 201 are essentially defined by the upper and lower ends of the gas exchange unit 62 and the upper and lower inner walls of the shell 10.

[0033] One end (left end) of the hollow fiber tubes GT of the horizontally oriented first gas exchange pad 611 and third gas exchange pad 623 is connected to the first chamber 141, and the other end (right end) is connected to the second chamber 132. One end (upper end) of the hollow fiber tubes GT of the vertically oriented second gas exchange pad 622 is connected to the gas inflow chamber 101, and the lower end is connected to the gas outflow chamber 201. One end (upper end) of the hollow fiber tubes HT of the vertically oriented heat exchange pad 612 is connected to the heat medium inflow chamber 102, and the lower end is connected to the heat medium outflow chamber 202. The first chamber 141 is connected to the gas inflow chamber 101, and the gas inlet 112 is connected to at least one of the first chamber 141 and the gas inflow chamber 101. The second chamber 132 is connected to the gas outflow chamber 201, and the gas outlet 121 is connected to at least one of the second chamber 132 and the gas outflow chamber 201. The heat medium inflow chamber 102 is in communication with the heat medium inlet 131 , and the heat medium outflow chamber 202 is in communication with the heat medium outlet 133 .

[0034] Therefore, the gas inflow chamber 101 is aligned with the gas outflow chamber 201 along the second direction (vertical direction), and the two are connected through the second gas exchange pad 622. Similarly, the heat medium inflow chamber 102 is aligned with the heat medium outflow chamber 202 along the second direction (vertical direction), and the two are connected through the heat exchange pad 612. The first chamber 141 is aligned with the second chamber 132 along the first direction (horizontal direction), and the two are connected through the first gas exchange pad 611 and the third gas exchange pad 623.

[0035] like Figure 6 and Figure 7As shown, the gas entering the gas inlet 112 into the gas inlet chamber 101 is divided into two paths: the first path of gas (indicated by the dotted arrow) enters the first chamber 141 connected to the gas inlet chamber 101, then flows through the first gas exchange pad 611 and the third gas exchange pad 623, enters the second chamber 132, and is finally discharged from the gas outlet 121. Figure 6 As shown by the dotted arrows, the gas flows through the third gas exchange pad 623; Figure 7 As shown by the dotted arrow, the gas flows through the first gas exchange pad 611. Therefore, the flow direction of the first gas is: gas inlet 112 → gas inflow chamber 101 → first chamber 141 → first gas exchange pad 611, third gas exchange pad 623 → second chamber 132 → gas outlet 121. Figure 6 As shown by the dotted arrows, the second gas flows through the second gas exchange pad 622, enters the gas outflow chamber 201, and is finally discharged from the gas outlet 121. Therefore, the flow direction of the second gas is: gas inlet 112 → gas inflow chamber 101 → second gas exchange pad 622 → gas outflow chamber 201 → gas outlet 121.

[0036] Both the gas exchange unit 62 and the hybrid exchange unit 61 include gas exchange pads. The gas exchange pad 611 of the hybrid exchange unit 61 (oriented along the second direction L2, or horizontally) is oriented in the same direction as one of the gas exchange pads 623 in the gas exchange unit 62, and is oriented perpendicularly to the other gas exchange pad 622. The two chambers 141 and 132 formed between the medium exchange module 60 and the housing 10 connect the identically oriented gas exchange pads 611 and 623 in the two exchange units 61 and 62. Furthermore, the gas exchange pads 611 and 623 in the two exchange units 61 and 62, oriented in the same direction, are connected via the gas inflow chamber 101 and the gas outflow chamber 201 formed between the medium exchange module 60 and the housing 10. Thus, through the connection between the gas inflow chamber 101 and the first chamber 141, gas can be supplied to the gas exchange pads 611, 622, and 623 in the two exchange units 61 and 62 simultaneously.

[0037] like Figure 8As shown, the inner wall of the first shell 11 is provided with a first partition 111 extending along the first direction L1, and the gas inflow chamber 101 and the heat medium inflow chamber 102 are formed on both sides of the first partition 111. First baffles 1011 are provided at both ends of the gas inflow chamber 101 along the first direction L1. Among them, the first baffle 1011 (the first baffle 1011 on the right side) near the third shell 13 or the second chamber 132 is a sealing plate to isolate the communication between the gas inflow chamber 101 and the second chamber 132, preventing gas from being discharged directly from the gas outlet 121 without passing through the gas exchange pad. The first baffle 1011 (the first baffle 1011 on the left side) near the fourth shell 14 or the first chamber 141 is a grid plate to connect the gas inflow chamber 101 and the first chamber 141, and supply gas to the horizontally oriented first and third gas exchange pads 611 and 623.

[0038] Similarly, third baffles 1023 are provided at both ends of the heat medium inflow chamber 102 along the first direction L1. The third baffle 1023 near the third shell 13 or the second chamber 132 (the third baffle 1023 on the right) is a grid plate, connecting the heat medium inflow chamber 102 with the heat medium inflow compartment 134, providing heat medium to the vertically oriented heat exchange pads 612. The third baffle 1023 near the fourth shell 14 or the first chamber 141 (the third baffle 1023 on the left) is a sealing plate, isolating the heat medium inflow chamber 102 from the first chamber 141, preventing heat medium from entering the first chamber 141 and blocking the first and third gas exchange pads 611 and 623.

[0039] like Figure 9 As shown, the inner wall of the second shell 12 is provided with a second baffle 122 extending along the first direction L1. A gas outflow chamber 201 and a heat medium outflow chamber 202 are formed on either side of the second baffle 122. Second baffles 2012 are provided at both ends of the gas outflow chamber 201 along the first direction L1. The second baffle 2012 (the right-hand second baffle 2012) located near the third shell 13 or the second chamber 132 is a grid plate, connecting the gas outflow chamber 201 with the second chamber 132 to facilitate gas discharge. The second baffle 2012 (the second baffle 2012 on the left) close to the fourth shell 14 or the first chamber 141 is a closed plate to isolate the gas outflow chamber 201 from the first chamber 141, and prevent the gas (the gas exchanged from the blood after oxygenation, with carbon dioxide as the main component) from entering the first chamber 141 in reverse. This will cause the oxygen content of the gas circulating in the first and third gas exchange pads 611 and 623 to decrease, resulting in a decrease in oxygenation efficiency, which is not desired.

[0040] Similarly, fourth baffles 2024 are provided at both ends of the heat medium outflow chamber 202 along the first direction L1. The fourth baffle 2024 near the third shell 13 or the second chamber 132 (the fourth baffle 2024 on the right) is a grid plate, which connects the heat medium outflow chamber 202 with the heat medium outflow compartment 135, allowing for the smooth discharge of partially cooled heat medium. The fourth baffle 2024 near the fourth shell 14 or the first chamber 141 (the fourth baffle 2024 on the left) is a sealing plate, which isolates the heat medium outflow chamber 202 from the first chamber 141, preventing heat medium from entering the first chamber 141 and blocking the hollow fiber tubes GT of the first and third gas exchange pads 611 and 623.

[0041] When the first shell 11 is assembled to the frame 20, the lower end of the first partition 111 abuts the upper side of the frame 21, the first baffles 1011 on the left and right sides abut the two rear side columns 23 on the upper side, and the third baffles 1023 on the left and right sides abut the two front side columns 22 on the upper side. Similarly, when the second shell 12 is assembled to the frame 20, the upper end of the second partition 122 abuts the lower side of the frame 21, the second baffles 2012 on the left and right sides abut the two rear side columns 23 on the lower side, and the fourth baffles 2024 on the left and right sides abut the two front side columns 22 on the lower side. In this way, the gas medium chambers 101, 201 and the heat medium chambers 102, 202 are sealed and isolated from each other, thereby defining a unique flow path for the gas and heat medium and preventing interference between the gas and heat medium.

[0042] This embodiment uses a grid plate to connect the gas medium chambers 101, 201 with the gas chambers 141, 132. This is beneficial to the stability of the oxygenator 100, particularly the internal structure of the housing 10. Compared to the conventional approach of leaving one end of the gas medium chamber 101, 201 open along the first direction L1 to connect with the gas chambers 141, 132, the grid plate with holes or hollows, by abutting against the frame 20, can improve the support of the housing 10, prevent the housing 10 from collapsing when subjected to external forces, and protect the internal structure of the housing 10 from damage.

[0043] Furthermore, the partitions 111 and baffles 1011 and 1023 of the first shell 11 are of the same height, while the partitions 122 and baffles 2012 and 2024 of the second shell 12 are of the same height, adapted to the nearly straight frame 21 and columns 22 and 23 of the frame 20, ensuring a tight contact between the partitions and baffles and the frame 20 without any gaps. Before the circumferential shell is assembled to the frame 20, a biocompatible adhesive material is typically applied to the outer surface of the frame 20 to aid in connecting the shell 10 and the frame 20 and improve the sealing of the chamber.

[0044] Depend on Figure 8 and Figure 9It can be intuitively seen that the partition board and the baffle roughly divide the space inside the shell into a double-chamber structure in the shape of a "day", and the width of the double chamber is equal to the thickness of the two exchange units 61 and 62 of the medium exchange module 60. There is only one connection in all chambers. For example, Figure 8 In the first shell 11 shown, the left side of the gas inlet chamber 101 and the right side of the hot medium inlet chamber 102 are grid plates, and all other parts are closed. Similarly, as Figure 9 shown in the second shell 12, the right side of the gas outlet chamber 201 and the right side of the hot medium outlet chamber 202 are grid plates, and all other parts are closed.

[0045] The connection scheme of the first shell 11 and the second shell 12 to the frame 20 is basically also applicable to the connection of the third shell 13 and the fourth shell 14 to the frame 20. The difference is only that, compared with the inner walls of the first shell 11 and the second shell 12 which need to be separated by partition boards, baffles, etc. to form relatively complex gas medium chambers 101, 201 and hot medium chambers 102, 202, the inner wall structures of the third shell 13 and the fourth shell 14 are relatively simple and there is no structure similar to partition boards and baffles. Therefore, the third shell 13 and the fourth shell 14 are only connected to the frame 20 by flanging on the edge, and there is no other partition structure that needs to abut against the frame 20 inside, so that the first chamber 141 is defined by the fourth shell 14 and the second chamber 132 is defined by the third shell 13.

[0046] For example, Figure 7 and Figure 10 shown, the inner wall of the third shell 13 is provided with a hot medium inlet compartment 134 and a hot medium outlet compartment 135 which are located in the second chamber 132 but isolated from the second chamber 132. The hot medium inlet compartment 134 and the hot medium outlet compartment 135 are in the shape of a flat pocket or sac, and extend as a whole along the second direction L2 (vertical direction), and the two are symmetrically arranged. One end (lower end) of the hot medium inlet compartment 134 along the second direction L2 is connected to the hot medium inlet 131, and the other end (upper end) is connected to the hot medium inlet chamber 102. One end (upper end) of the hot medium outlet compartment 135 along the second direction L2 is connected to the hot medium outlet 133, and the other end (lower end) is connected to the hot medium outlet chamber 202. Among them, the connection between the hot medium inlet compartment 134 and the hot medium inlet chamber 102 is realized by setting the third baffle 1023 close to the hot medium inlet compartment 134 as a grid plate, and the connection between the hot medium outlet compartment 135 and the hot medium outlet chamber 202 is realized by setting the fourth baffle 2024 close to the hot medium inlet compartment 134 as a grid plate.

[0047] The hot medium enters the hot medium inlet compartment 134 through the hot medium inlet 131, then enters the hot medium inlet chamber 102, and then flows through the hollow fiber tube HT of the heat exchange pad 612 and enters the hot medium outlet compartment 135, and finally flows out from the hot medium outlet 133. Therefore, as Figure 7As shown by the solid arrows, the flow direction of the heat medium is: heat medium inlet 131 → heat medium inflow compartment 134 → heat medium inflow cavity 102 → heat exchange pad 612 → heat medium outflow cavity 202 → heat medium outflow compartment 135 → heat medium outlet 133.

[0048] As described above, the gas exchange pad (first gas exchange pad 611) in the same cavity (mixed exchange cavity 34) as the heat exchange pad 612 is oriented perpendicularly thereto, while the remaining gas exchange pads (second and third gas exchange pads 622, 623) are in another cavity (gas exchange cavity 35). Therefore, the heat medium inlet 131 is connected to the heat medium inlet cavity 102 by the heat medium inlet compartment 134 provided in the housing 10, and the heat medium outlet 133 is connected to the heat medium outflow cavity 202 by the heat medium outflow compartment 135, so that the heat medium can only be supplied to the heat exchange pad 612 through the heat medium inflow compartment 134 and the heat medium inflow cavity 102, and finally flows out from the heat medium inflow cavity 102 and the heat medium outflow compartment 135. In this way, the only flow path of the heat medium is defined, preventing the heat medium from flowing through the gas exchange pads 611, 622, 62, which would cause the gas exchange pads to be blocked and fail.

[0049] Furthermore, the heat medium inlet 131 and heat medium outlet 133 are located on the same side of the housing 10 and extend horizontally in the second direction L2, perpendicular to the extension direction of the hollow fiber tubes HT of the heat exchange mat 612. This allows the heat medium to enter through the heat medium inlet 131 and, thanks to the connectivity provided by the heat medium inlet compartment 134, make two nearly 90-degree turns before entering the heat medium inflow chamber 102. Subsequently, the heat medium flows through the inlet end (upper end) of the hollow fiber tubes HT of the heat exchange mat 612 and, after merging into the heat medium outflow chamber 202, also makes two nearly 90-degree turns before entering the heat medium outlet 133. Thus, the heat medium inlet 131 and heat medium outlet 133 are staggered relative to the inlet and outlet ends of the hollow fiber tubes HT of the heat exchange mat 612, preventing the heat medium from directly impacting the hollow fiber tubes HT and causing uneven distribution within the heat exchange mat 612. In addition, the heat medium needs to pass through a tortuous path when entering or flowing out, which can stabilize the pressure of the heat medium (especially the pressure when entering), so that the heat medium can flow smoothly through the heat exchange pad 612 and provide uniform heating / insulation effect for the blood at various locations in the heat exchange pad 612.

[0050] Furthermore, compared to known embodiments such as CN107929839A and CN116999637A, which point the heat medium inlet and outlet downward and are located on two different sides of the oxygenator housing, locating the heat medium inlet 131 and the heat medium outlet 133 on the same side of the housing 10 provides better accessibility. In this embodiment, the heat medium inlet 131 and the heat medium outlet 133 point in a similar direction to the blood inlet 112 when the oxygenator 100 is in operation, making it easier for clinicians to connect the tubing.

[0051] Furthermore, the cross-sectional area of the heat medium inflow compartment 134 gradually increases in the direction away from the heat medium outflow compartment 135 (upward). Similarly, the cross-sectional area of the heat medium outflow compartment 135, which is symmetrically arranged with the heat medium inflow compartment 134, also exhibits the same variation characteristics, namely, gradually increasing in the direction away from the heat medium inflow compartment 134 (downward). In other words, along the direction of heat medium flow, the cross-sectional area of the heat medium inflow compartment 134 gradually widens, while the cross-sectional area of the heat medium outflow compartment 135 gradually narrows. According to Bernoulli's theorem, the gradually widening heat medium inflow compartment 134 results in a higher pressure of the heat medium in the heat medium inflow chamber 102, allowing the heat medium to flow smoothly through the small hollow fiber tubes HT of the heat exchange pad 612. Similarly, the gradually narrowing heat medium outflow compartment 135 also provides high pressure of the heat medium in the heat medium outflow chamber 202, accelerating the outflow of the heat medium and improving heat exchange efficiency.

[0052] like Figure 10 As shown, the heat medium inflow compartment 134 and the heat medium outflow compartment 135 each have an open end 136 facing away from the heat medium inlet 131 and the heat medium outlet 133, respectively. The open end 136 of the heat medium inflow compartment 134 communicates with the heat medium inflow chamber 102, while the open end 136 of the heat medium outflow compartment 135 communicates with the heat medium outflow chamber 202. The open end 136 includes a first end 137 (horizontal end) extending along the first direction L1 and a second end 138 (vertical end) extending along the second direction L2. The first ends 137 of both compartments 134 and 135 abut against the column, the second end 138 of the heat medium inflow compartment 134 abuts against the first shell 11, and the second end 138 of the heat medium outflow compartment 135 abuts against the second shell 12. The inner ends of the third baffle 1023 and the fourth baffle 2024, which serve as grid plates, abut against the column.

[0053] Specifically, each column has two mutually perpendicular outer straight surfaces. Among them, the horizontal first end 137 of the heat medium inflow compartment 134 abuts the right side straight surface of the front side column 22 in the upper right corner, the upper side straight surface of the front side column 22 in the upper right corner abuts the lower end surface of the third baffle 1023 (grid plate), and the vertically upward second end 138 of the heat medium inflow compartment 134 abuts the lower end of the first shell 11. The horizontal first end 137 of the heat medium outflow compartment 135 abuts the right side straight surface of the front side column 22 in the lower right corner, the lower side straight surface of the front side column 22 in the lower right corner abuts the upper end surface of the fourth baffle 2024 (grid plate), and the vertically downward second end 138 of the heat medium outflow compartment 135 abuts the upper end of the second shell 12. Similarly, these end surfaces can also be supplemented with adhesive materials when abutting to facilitate fixation and improve sealing.

[0054] With the above solution, the communication between the heat medium inlet compartment 134 and the heat medium inlet cavity 102, and the heat medium outlet compartment 135 and the heat medium outlet cavity 202 has better sealing performance, preventing the heat medium from entering the second cavity 132 and blocking the gas exchange pad.

[0055] The above is only an implementation method of the present application and does not limit the scope of the present application. Any equivalent structure or equivalent process transformation made using the description and drawings of this application, or directly or indirectly applied in other related technical fields, are also included in the scope of protection of the present application.

Claims

1. Oxygenator, including: The housing is substantially square and has a first direction, a second direction and a third direction perpendicular to each other; The medium exchange module is arranged in a housing and includes a mixing exchange unit and a gas exchange unit; the mixing exchange unit includes a first gas exchange pad and a heat exchange pad stacked along a third direction, the hollow fiber tubes of the first gas exchange pad extending along the first direction, and the hollow fiber tubes of the heat exchange pad extending along the second direction; the gas exchange unit includes a second gas exchange pad and a third gas exchange pad stacked along the third direction, the hollow fiber tubes of the second gas exchange pad extending along the second direction, and the hollow fiber tubes of the third gas exchange pad extending along the first direction; Its characteristics are: A first chamber and a second chamber are formed between the two ends of the medium exchange module along the first direction and the inner wall of the shell; a gas inflow chamber and a heat medium inflow chamber, which are isolated from each other, are formed between one end of the medium exchange module along the second direction and the inner wall of the shell, and a gas outflow chamber and a heat medium outflow chamber, which are isolated from each other, are formed between the other end of the medium exchange module and the inner wall of the shell; Both ends of the hollow fiber tubes of the first gas exchange pad and the third gas exchange pad are connected to the first chamber and the second chamber respectively, both ends of the hollow fiber tube of the second gas exchange pad are connected to the gas inflow chamber and the gas outflow chamber respectively, and both ends of the hollow fiber tube of the heat exchange pad are connected to the heat medium inflow chamber and the heat medium outflow chamber respectively; The first chamber is in communication with the gas inflow chamber, and the gas inlet is in communication with at least one of the first chamber and the gas inflow chamber; The second chamber is in communication with the gas outflow chamber, and the gas outlet is in communication with at least one of the second chamber and the gas outflow chamber; The heat medium inflow cavity is communicated with the heat medium inlet, and the heat medium outflow cavity is communicated with the heat medium outlet.

2. The oxygenator according to claim 1, wherein the gas entering the gas inlet chamber through the gas inlet is divided into two paths: The first gas enters the first chamber connected to the gas inlet chamber, then flows through the hollow fiber tubes of the first gas exchange pad and the third gas exchange pad, enters the second chamber, and is discharged from the gas outlet; The second gas flows through the hollow fiber tube of the second gas exchange pad, enters the gas outflow cavity, and is discharged from the gas outlet.

3. The oxygenator of claim 1 , wherein the housing comprises: The first shell and the second shell are respectively located outside the first end and the second end of the medium exchange module, and the first end and the second end are two ends of the medium exchange module along the second direction; The inner wall of the first shell is provided with a first partition plate extending in a first direction, and the gas inflow cavity and the heat medium inflow cavity are formed on both sides of the first partition plate; The inner wall of the second shell is provided with a second partition plate extending in the first direction, and the gas outflow cavity and the heat medium outflow cavity are formed on both sides of the second partition plate; Preferably, first baffles are provided at both ends of the gas inflow chamber along the first direction; wherein the first baffle close to the first chamber is a grid plate to allow the gas inflow chamber to communicate with the first chamber; and the first baffle close to the second chamber is a closing plate to isolate the gas inflow chamber from communicating with the second chamber. Second baffles are provided at both ends of the gas outflow chamber along the first direction; wherein, the second baffle close to the first chamber is a closing plate to isolate the gas outflow chamber from being connected to the first chamber; the second baffle close to the second chamber is a grid plate to enable the gas outflow chamber to be connected to the second chamber.

4. The oxygenator of claim 3, wherein the housing comprises: The third shell and the fourth shell are respectively located outside the third end and the fourth end of the medium exchange module, and the third end and the fourth end are two ends of the medium exchange module along the first direction; The first chamber is formed in the fourth shell, and the second chamber is formed in the third shell; The heat medium inlet and the heat medium outlet are provided on the third shell, and the inner wall of the third shell is provided with a heat medium inflow compartment and a heat medium outflow compartment isolated from the second chamber; the heat medium inflow compartment is connected to the heat medium inlet and the heat medium inflow chamber, and the heat medium outflow compartment is connected to the heat medium outlet and the heat medium outflow chamber; Preferably, third baffles are provided at both ends of the heat medium inflow cavity along the first direction; wherein the third baffle close to the third shell is a grid plate to connect the heat medium inflow cavity with the heat medium inflow compartment; and the third baffle close to the fourth shell is a closing plate to isolate the heat medium inflow cavity from the first cavity. Fourth baffles are provided at both ends of the heat medium outflow chamber along the first direction; wherein, the fourth baffle close to the third shell is a grid plate to connect the heat medium outflow chamber with the heat medium outflow compartment; the fourth baffle close to the fourth shell is a closing plate to isolate the heat medium outflow chamber from the first chamber.

5. The oxygenator according to claim 4, wherein a frame is provided in the housing, the frame comprising: A roughly square frame, front side pillars extending from the four corners of the frame to the front, and rear side pillars extending from the four corners of the frame to the rear; The heat medium inlet compartment and the heat medium outlet compartment have open ends facing away from the heat medium inlet and the heat medium outlet, respectively, and the open ends include a first end extending in a first direction and a second end extending in a second direction; the first ends of the two compartments abut against the front side column, the second end of the heat medium inlet compartment abuts against the first shell, and the second end of the heat medium outlet compartment abuts against the second shell; The inner ends of the third baffle and the fourth baffle close to the second chamber are both in contact with the front side column.

6. Oxygenator, including: The housing is substantially square and has a first direction, a second direction and a third direction perpendicular to each other; The medium exchange module is arranged in a housing and includes a mixing exchange unit and a gas exchange unit; the mixing exchange unit includes a first gas exchange pad and a heat exchange pad stacked along a third direction, the hollow fiber tubes of the first gas exchange pad extending along the first direction, and the hollow fiber tubes of the heat exchange pad extending along the second direction; the gas exchange unit includes a second gas exchange pad and a third gas exchange pad stacked along the third direction, the hollow fiber tubes of the second gas exchange pad extending along the second direction, and the hollow fiber tubes of the third gas exchange pad extending along the first direction; Its characteristics are: A heat medium inflow cavity is formed between the outer wall of one end of the hybrid exchange unit along the second direction and the inner wall of the shell, and a heat medium outflow cavity is formed between the outer wall of the other end and the inner wall of the shell; the heat medium inflow cavity, the heat medium outflow cavity, and the hollow fiber tubes of the first gas exchange pad, the second gas exchange pad, and the third gas exchange pad are all sealed and isolated; The inner wall of the shell is provided with a heat medium inlet compartment and a heat medium outflow compartment. The heat medium inlet compartment connects the heat medium inlet with the heat medium inlet cavity, and the heat medium outflow compartment connects the heat medium outlet with the heat medium outflow cavity.

7. The oxygenator according to claim 6, wherein the heat medium enters the heat medium inflow compartment through the heat medium inlet, then enters the heat medium inflow cavity, then flows through the hollow fiber tubes of the heat exchange pad, enters the heat medium outflow compartment, and flows out from the heat medium outlet.

8. The oxygenator according to claim 6, A third baffle is provided at both ends of the heat medium inflow cavity along the first direction; wherein, The third baffle plate close to the heat medium inflow compartment is a grid plate to connect the heat medium inflow cavity with the heat medium inflow compartment; Fourth baffles are provided at both ends of the heat medium outflow cavity along the first direction; wherein the fourth baffle close to the heat medium outflow compartment is a grid plate to connect the heat medium outflow cavity with the heat medium outflow compartment.

9. The oxygenator according to claim 6, wherein a frame is provided in the housing, the frame comprising: A roughly square frame with columns extending from the four corners of the frame to the front and back; The heat medium inflow compartment and the heat medium outflow compartment have open ends facing away from the heat medium inlet and the heat medium outlet, respectively. The open ends include a first end extending along a first direction and a second end extending along a second direction. The first end abuts against the column. The inner ends of the third baffle and the fourth baffle close to the heat medium inflow compartment / heat medium outflow compartment abut against the column.

10. The oxygenator according to claim 6, wherein the cross-sectional areas of the flow paths of the heat medium inflow compartment and the heat medium outflow compartment gradually increase in directions away from each other; Preferably, the heat medium inlet and the heat medium outlet are located on the same side of the shell and are perpendicular to the extending direction of the hollow fiber tubes of the heat exchange mat.

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