Hollow fiber mass transfer drive for extracorporeal blood circulation.

Abstract

An apparatus for extracorporeal blood circulation comprising: a potting body including an oxygenator module comprising at least two of a plurality of circular hollow fiber mat layers; a heat exchanger module comprising at least two of the plurality of circular hollow fiber mat layers; a blood inlet adjacent a first end of the potting body; and a blood outlet adjacent a second end of the potting body. The apparatus comprises a gas inlet and a gas outlet, and a fluid inlet and a fluid outlet. A first hollow fiber mat of the plurality of hollow fiber mats includes a plurality of hollow fibers aligned in a direction that is angled with respect to the alignment direction of a plurality of hollow fibers of a second hollow fiber mat of the plurality of hollow fiber mats, and the plurality of hollow fiber mats are aligned to have similar orientations to one another.

Description

[Technical field]

[0001] The present disclosure relates to the field of devices for extracorporeal blood circulation. More specifically, the present disclosure relates to an extracorporeal blood oxygenator and its components, such as an oxygenator and a heat exchanger. [Background technology]

[0002] The device for extracorporeal blood circulation can include two parts, an oxygenator and a heat exchanger, for exchanging O2 and CO2 between blood and a gas mixture through the walls of a semi-permeable hollow fiber membrane, as well as exchanging heat between blood and a heating or cooling fluid. When the gas mixture and the heating / cooling fluid (aqueous solution) circulate inside the hollow fiber chamber, the blood comes into contact with the outer surface of the hollow fibers. In devices using such technology, the hollow fibers can be woven in different ways. They can be in the form of monofilaments or multifilaments woven around a core, or can be constructed as a mat wound around a core, or can be stacked in mat layers built up one by one (without a core). Various examples of this technology are known in the art.

[0003] However, there remains a need for an extracorporeal blood circulation device that reduces the high blood-side pressure drop that can damage blood cells, and a device that provides a simplified formation and manufacturing process while reducing the formation of clots in the blood. Summary of the Invention

[0004] Embodiments of the present invention include an oxygen-delivery hollow fiber membrane woven into a stacked hollow fiber mat layer, the structure of which is specifically envisioned to provide higher gas exchange efficiency and better oxygen delivery, a method for manufacturing the hollow fiber membrane, and an oxygen-delivery assembly made with the hollow fiber membrane, which is more easily manufactured.

[0005] According to one example ("Example 1"), an oxygenator for use in conjunction with extracorporeal blood circulation includes a potting body having a first alignment feature defining an alignment axis, an oxygenator module including a plurality of circular hollow fiber mat layers having a second alignment feature configured to align with the first alignment feature of the potting body to define an orientation of each of the plurality of hollow fiber mat layers relative to the alignment axis, a heat exchanger module including at least two of the plurality of circular hollow fiber mat layers, a blood inlet positioned proximate a first end of the potting body, and a blood outlet positioned proximate a second end of the potting body opposite the first end. The apparatus further includes a gas inlet and a gas outlet configured to direct a gas mixture through a plurality of hollow fibers of the plurality of hollow fiber mat layers, and a fluid inlet and a fluid outlet configured to supply and exhaust a heater / cooler (H / C) fluid through a portion of the potting body. In the apparatus, a first layer of the plurality of hollow fiber mat layers includes a first plurality of parallel hollow fibers oriented at a first angle relative to the alignment axis, and a second layer of the plurality of hollow fiber mat layers includes a second plurality of parallel hollow fibers oriented at a second angle relative to the alignment axis, the first angle and the second angle being on opposite sides of the alignment axis.

[0006] According to a second example ("Example 2"), the apparatus of Example 1 is configured such that the gas mixture passes through at least two of the plurality of hollow fiber mat layers in the oxygenator module.

[0007] According to a third example ("Example 3"), in the apparatus described in Example 1, the H / C fluid is configured to pass through at least two of the plurality of hollow fiber mat layers in the heat exchanger module.

[0008] According to a fourth example ("Example 4"), in the device described in Example 1, the potting body further comprises a blood distribution grid positioned between the blood inlet and the heat exchanger module.

[0009] According to a fifth example ("Example 5"), in the device described in Example 1, the potting body further comprises a blood separation grid positioned between the heat exchanger module and the oxygenator module.

[0010] According to a sixth example ("Example 6"), in the device described in Example 1, the potting body further comprises a blood collection grid positioned between the oxygenator module and the blood outlet.

[0011] According to a seventh example ("Example 7"), the device described in Example 1 comprises a first case portion positioned adjacent to a first end of the potting body and a second case portion positioned adjacent to a second end of the potting body.

[0012] According to an eighth example ("Example 8"), in the apparatus described in Example 1, each of the plurality of hollow fiber mat layers includes a plurality of yarns coupled to a plurality of hollow fibers.

[0013] According to a ninth example ("Example 9"), in the device described in Example 8, the multiple threads are arranged at a non-orthogonal angle to the arrangement of the multiple hollow fibers.

[0014] According to a tenth example ("Example 10"), an assembly of multiple hollow fiber mat layers for use in an extracorporeal blood circulation device includes a first hollow fiber mat layer and a second hollow fiber mat layer positioned adjacent to each other and each including a plurality of parallel threads and a plurality of parallel hollow fibers, in which the threads in the first hollow fiber mat and the second hollow fiber mat are positioned parallel to an alignment axis, the hollow fibers in the first hollow fiber mat layer are parallel to a second axis that is disposed at a first angle to the alignment axis, and the hollow fibers in the second hollow fiber mat layer are parallel to a third axis that is disposed at the second angle to the alignment axis and is located on an opposite side of the alignment axis from the first angle.

[0015] According to an eleventh example ("Example 11"), in the assembly described in Example 10, the first hollow fiber mat layer and the second hollow fiber mat layer are circular in shape.

[0016] According to a twelfth example ("Example 12"), in the assembly described in Example 10, the second axis forms an angle with the third axis that is greater than 0 degrees and less than or equal to 50 degrees.

[0017] According to a thirteenth example ("Example 13"), in the assembly described in Example 12, each of the multiple hollow fiber mat layers has at least two grooves that align with at least two grooves of a hollow fiber mat layer positioned adjacent to each other.

[0018] According to a fourteenth example ("Example 14"), in the assembly described in Example 13, each of the multiple hollow fiber mat layers is aligned to have a similar orientation to one another.

[0019] According to a fifteenth example ("Example 15"), in the assembly described in Example 12, the multiple hollow fiber mat layers include a third hollow fiber mat layer positioned directly below the second hollow fiber mat layer and a fourth hollow fiber mat layer positioned directly below the third hollow fiber mat layer.

[0020] According to a sixteenth example ("Example 16"), in the assembly described in Example 15, the plurality of hollow fibers of the third hollow fiber mat layer are aligned along a second axis, and the plurality of hollow fibers of the fourth hollow fiber mat layer are aligned along a third axis.

[0021] According to a seventeenth example ("Example 17"), an oxygenator for use in conjunction with extracorporeal blood circulation includes a potting body including a blood inlet near a first end, a blood outlet near a second end opposite the first end, and a lateral exterior surface including a first alignment feature defining an alignment axis. The apparatus further includes an oxygenator module including a plurality of circular hollow fiber mat layers including a plurality of hollow fibers coupled to a plurality of yarns, each of the layers including a second alignment feature configured to align with the first alignment feature of the potting body to define an orientation of each of the plurality of hollow fiber mat layers relative to the alignment axis. The apparatus further comprises a gas inlet configured to supply a gas mixture to the plurality of hollow fibers, and a first layer of the plurality of hollow fiber mat layers includes a first plurality of parallel hollow fibers disposed at a first angle relative to the alignment axis, and a second layer of the plurality of hollow fiber mat layers adjacent to the first layer includes a second plurality of parallel hollow fibers disposed at a second angle relative to the alignment axis, the first angle and the second angle being on opposite sides of the alignment axis.

[0022] According to an eighteenth example ("Example 18"), in the apparatus of Example 17, the first angle and the second angle are diagonal with respect to the alignment axis.

[0023] According to a nineteenth example ("Example 19"), in the device described in Example 17, both of the first angle and the second angle are greater than 0 degrees and less than or equal to 25 degrees.

[0024] According to a twentieth example ("Example 20"), in the device described in Example 19, in each of the hollow fiber mat layers, the multiple yarns are arranged at an angle that is not perpendicular to the arrangement of the multiple hollow fibers.

[0025] While multiple embodiments are disclosed, other embodiments will become apparent to those skilled in the art based on the following detailed description, which shows and describes illustrative embodiments. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief description of the drawings]

[0026] This specification includes drawings for a further understanding of the invention, which are incorporated in and constitute a part of this specification, and which illustrate embodiments and, together with the description, serve to explain the principles of the present disclosure.

[0027] [Figure 1] FIG. 1 is a schematic diagram of a patient undergoing extracorporeal blood circulation. [Diagram 2] FIG. 1 is a schematic front view of an oxygenator device according to some embodiments of the present disclosure. [Diagram 3] FIG. 3 is a left lateral axial side view of the oxygenator device of FIG. 2 according to an embodiment of the present disclosure. [Figure 4] 3 is a transverse cross-section of the oxygenator device taken along line AA in FIG. 2. [Diagram 5] FIG. 3 is an exploded view of the oxygenator device of FIG. 2 according to an embodiment of the present disclosure. [Figure 6] FIG. 3 is a perspective view of the potting body of the oxygenator device of FIG. 2 according to an embodiment of the present disclosure. [Figure 7] FIG. 7 is an exploded view of multiple hollow fiber mat layers according to an embodiment of the present disclosure before being stacked in a potting mold to form the potting body of FIG. 6. [Figure 8] 8 illustrates a first element of multiple hollow fiber mat layers of FIG. 7 according to an embodiment of the present disclosure. [Figure 9]8 illustrates a second element of the multiple hollow fiber mat layers of FIG. 7 according to an embodiment of the present disclosure. [Figure 10] 8 illustrates one of the hollow fiber mat layers of FIG. 7 prior to cutting in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] As will be readily appreciated by those skilled in the art, the various aspects of the present disclosure may be implemented by any number of methods and apparatus arranged to perform the intended functions. It should be noted that the drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate the various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0029] FIG. 1 is a schematic diagram of a system including a patient 10 requiring extracorporeal blood circulation. In these embodiments, the patient 10 is connected by a first conduit 12 to an extracorporeal blood circulation device 20 (also generally referred to herein as an oxygenator device 20) through which blood can be transported from the patient 10 to the oxygenator device 20. The oxygenator device 20 includes a second conduit 14 extending from the oxygenator device 20 to the patient 10 for returning the blood circulating in the device 20 back to the patient 10. In these embodiments, O2 and CO2 are exchanged between the blood and a gas mixture in the oxygenator device 20, as described further herein. The oxygenator device 20 is also configured to exchange temperature (hot or cold) between the blood and a heating / cooling (H / C) fluid in the oxygenator device 20. In some embodiments, the H / C fluid is water or an aqueous solution.

[0030] FIG. 2 is a front view of the oxygenator device 20 having an oxygenator module (not shown) and a heat exchanger module (not shown). The oxygenator device 20 has an upper portion 26 and a lower portion 28. In various embodiments, the oxygenator 20 comprises a gas inlet 30 configured to receive a gas mixture, a gas outlet 32 ​​configured to output a gas mixture, an H / C fluid inlet 34 for receiving an H / C fluid, an H / C fluid outlet 36 for outputting an H / C fluid, a blood inlet 38 for receiving blood from the patient 10 (FIG. 1), and a blood outlet (not shown) for outputting blood from the oxygenator device 20 back to the patient 10. The oxygenator device 20 further comprises a venous sampling port 44 and a first purification port 42a, as will be further described with reference to FIG. 3. In some embodiments, the oxygenator device 20 further comprises a bracket attachment 46 to allow mounting and rotation of the oxygenator device 20.

[0031] FIG. 3 is a side view of the oxygenator device 20. As shown, the oxygenator device 20 includes a front portion 52 and a rear portion 54. The front portion 52 includes a blood inlet end cap 56 having a blood inlet 38 configured to receive blood from the first line 12 (FIG. 1), and the rear portion 54 includes a blood outlet end cap 58 having a blood outlet 40 for providing an outlet for blood to be returned to the patient 10 (FIG. 1) via the second line 14 (FIG. 1). As also shown in FIG. 3, the oxygenator device 20 includes a gas inlet 30 located on a side of the oxygenator device 20. The oxygenator device 20 includes a plurality of purge ports 42, including at least a first purge port 42a and a second purge port 42b. The purge ports 42a, 42b can allow for air removal during an initial irrigation stage before the oxygenator device 20 is used on a patient. During operation, i.e., when blood and gases are flowing through the device 20, the purge ports 42a, 42b can be reopened to remove entrained air from the blood. The purge ports 42a, 42b can also be opened after operation of the device 20, i.e., when blood is no longer flowing through the device 20, to ensure that all blood is properly drained from the device 20 and returned to the patient. The oxygenator device 20 further comprises a pedestal 59 positioned on its bottom surface to support and stabilize the device 20.

[0032] 2, the oxygenator device 20 includes a front portion 52 and a rear portion 54. In these embodiments, the front portion 52 surrounds at least a portion of the heat exchanger module 24, and the rear portion 54 surrounds at least a portion of the oxygenator module 22, as shown in FIG.

[0033] 4 shows a transverse cross-section of the oxygenator device 20 taken along line AA in FIG. 2. In the exemplary embodiment of FIG. 4, the oxygenator device 20 comprises an oxygenator module 22 and a heat exchanger module 24 positioned adjacent to the oxygenator module 22. Both modules 22, 24 are provided with hollow fiber mat layers stacked vertically adjacent to each other. The heat exchanger module 24 is adjacent to a blood inlet distribution grid 60 on the right side toward the front portion 52 of the oxygenator device 20. The blood inlet distribution grid 60 receives blood input from the blood inlet 38 and distributes the blood within the blood inlet distribution grid 60 before it enters the heat exchanger module 24. The heat exchanger module 24 is adjacent to a separation grid 62 on the left side toward the rear portion 54, which provides a physical separation between the oxygenator module 22 and the heat exchanger module 24 and distributes the blood flowing through the heat exchanger module 24 towards the oxygenator module 22. As such, the heat exchanger module 24 is positioned on the opposite side of the separation grid 62 from the oxygenator module 22, which is positioned further toward the rear portion 54 of the oxygenator device 20. The heat exchanger module 24 is positioned vertically below the H / C fluid inlet chamber 66 and vertically above the pedestal 59 and the H / C fluid outlet chamber 70. The oxygenator module 22 is adjacent to the blood outlet collection grid 64 on the left side further toward the rear portion 54 of the oxygenator device 20, which is configured to collect blood exiting the oxygenator module 22 before the blood is discharged through the blood outlet 40. As shown, the gas inlet chamber 68 and bracket attachment 46 are positioned vertically above the oxygenator module 22. The gas outlet chamber 72 is positioned vertically below the oxygenator module 22.

[0034] Thus, each of the oxygenator module 22 and the heat exchanger module 24 typically includes two portions or two halves. As will be further described below, the oxygenator module 22 has a portion configured to communicate with the gas inlet chamber 68 and a portion configured to communicate with the gas outlet chamber 72. Similarly, the heat exchanger module 24 has a portion configured to communicate with the H / C fluid inlet chamber 66 and a portion configured to communicate with the H / C fluid outlet chamber 70. As shown, the front portion 52 of the oxygenator device 20 includes the blood inlet 38 and the rear portion 54 of the oxygenator device 20 includes the blood outlet 40. With this configuration, when blood is driven to flow through both the heat exchanger module 24 and the oxygenator module 22 from the blood inlet 38 to the blood outlet 40, the blood comes into contact with the fluid mixture and gas (by inserting appropriate hollow fiber membranes in the heat exchanger module 24 and the oxygenator module 22) to provide sufficient heat and gas exchange.

[0035] 5 is an exploded view of the oxygenator device 20, showing the assembly of parts within the oxygenator device 20. Referring to this figure, the oxygenator device 20 includes a blood pathway including a blood inlet end cap 56 with a blood inlet 38 and a purification port 42a, a potting body 80, and a blood outlet end cap 58 with a blood outlet 40 and a purification port 42b. The potting body 80 includes a blood inlet distribution grid 60, a heat exchanger module 24, a separation grid 62, an oxygenator module 22, and a blood outlet collection grid 64, which are fitted together into a single (potting) part. The open ends of the hollow fibers on the outer surface of the potting body allow H / C fluids and gases to enter the cavities of the heat exchanger 24 and the oxygenator 22.

[0036] The blood inlet end cap 56 is provided with a number of peripheral cavities 74, which are mechanically fitted into corresponding peripheral notches 61 in the blood inlet distribution grid 60 of the potting body 80. The airtightness between the blood inlet end cap 56 and the blood inlet distribution grid 60 is obtained by casting resin along the two circular contact surfaces of the blood inlet end cap 56 and the blood inlet distribution grid 60. Similarly, at the opposite end of the potting body 80, the blood outlet end cap 58 is provided with a number of peripheral cavities 76, which are mechanically fitted into corresponding peripheral notches 65 in the outlet collection grid 64 of the potting body 80. The airtightness between the blood outlet end cap 58 and the outlet collection grid 64 is obtained by casting resin along the circular contact surfaces of the blood outlet end cap 58 and the outlet collection grid 64. In this way, the entire blood chamber including the blood inlet end cap 56, the blood outlet end cap 58 and the potting body 80 is joined by one airtight member.

[0037] Blood enters the oxygenator device 20 through the blood inlet 38 in the blood inlet end cap 56, passes through a blood inlet distribution grid 60, layers of hollow fiber mat that are laminated to form the heat exchanger module 24, a separation grid 62, layers of hollow fiber mat that are laminated to form the oxygenator 22, and an outlet collection grid 64, before reaching the blood outlet 40 in the blood outlet end cap 58. The blood inlet distribution grid 60, separation grid 62, and outlet collection grid 64 are circular plastic parts with relatively large holes (1 mm to 8 mm) through their surfaces and are configured to hold the elements of the heat exchanger module 24 and oxygenator module 22 in place and ensure that the blood flowing therethrough is evenly distributed. The remainder of the apparatus 20 includes an outer case that encloses the H / C fluid chamber and the gas chamber, i.e., an H / C fluid collector 82 (including an H / C fluid inlet 34 and an H / C fluid outlet 36) and a gas collector 78 (which includes a gas inlet 30 and a gas outlet 32, and further includes a bracket attachment 46 and a pedestal 59, as shown in FIG. 2).

[0038] The H / C fluid collector 82 is externally positioned above the portion of the potting body 80 corresponding to the heat exchanger module 24, and assembled with the blood inlet end cap 56 by resin casting so as to make the circular right side of the H / C fluid chamber airtight. The left circular edge of the H / C fluid collector 82 is externally positioned to correspond to the separation grid 62, and is airtightly joined to the potting body 80 by resin casting. In this way, the entire H / C fluid chamber is airtight. The H / C fluid chamber is divided into two halves by two seal gaskets 56a, 56b, i.e., includes the H / C fluid inlet chamber 66 and the H / C fluid outlet chamber 70 (shown in FIG. 4), and the two seal gaskets are inserted along two alignment features, which are illustratively two diametrically opposed longitudinal grooves 88 on the outer surface of the potting body 80 (shown in FIG. 6). The H / C fluid flows to (and away from) the heat exchanger module 24 through the gap between the inner surface of the H / C fluid collector 82 and the outer surface of the potting body 80 within the H / C fluid chamber, forming an H / C fluid inlet chamber 66 and an H / C fluid outlet chamber 70.

[0039] Similarly, the gas collector 78 is externally positioned correspondingly to the oxygenator module 22 and the outer surface of the potting body 80, and assembled with the blood outlet end cap 58 by resin casting so as to make the circular left side of the gas chamber of the device 20 airtight. The right circular edge of the gas collector 78 is externally positioned correspondingly to the separation grid 62 and adjacent to the H / C fluid collector 82, and is airtightly joined to the potting body 80 by resin casting. In this way, the gas chamber is completely airtight. Also, the gas chamber is divided into two halves, the gas inlet chamber 68 and the gas outlet chamber 72 (shown in FIG. 4), by two sealing gaskets 59a, 59b, which are inserted along two alignment features, which are illustratively two diametrically opposed longitudinal grooves 88 on the outer surface of the potting body 80 (see FIG. 6). Gas enters (and exits) the oxygenator module 22 through a gas chamber formed by the gap between the inner surface of the gas collector 78 and the outer surface of the potting body 80, thereby forming a gas inlet chamber 68 and a gas outlet chamber 72.

[0040] 6 is a perspective view of the potting body 80 of the oxygenator device 20 after it has been released from the potting mold and the lateral exterior surfaces 86 of the potting body 80 have been faceted to provide the potting body with a multi-sided polygonal shape extending along the Z axis and open ends of the hollow fibers of the two modules 22 and 24, thereby providing passages to the cavities of the two modules for circulation of H / C fluids and gases. Lines 84 indicate some of the many surfaces provided by the faceting. The potting body 80 is formed by high speed centrifugation about the Z axis of a cylindrical potting mold, and the potting body is pre-filled with a plurality of hollow fiber mat layers 90 (shown in FIG. 7), which are stacked one by one to form both the heat exchanger module 24 and the oxygenator module 22. A certain amount of resin (usually polyurethane, initially liquid) is poured into the rotating mold and hardened against the mold wall by pressing with centrifugal force. The difference between the potting outer diameter 89 and the potting inner diameter 87 is usually in the range of 7 mm to 10 mm, preferably 8 mm. The potting outer diameter 89 may be in the range of 7 cmm to 18 cm, and is 12 cm in the preferred embodiment. Thus, the potting body 80 provides a large and unobstructed internal passage for blood flow, whereby the oxygenator device 20 provides the advantage of a significantly reduced value of blood pressure drop. The potting body 80 comprises a rear end 81 and a front end 83. The hollow fiber mat layer of the heat exchanger module 24 is positioned towards the rear end 81 and is stacked adjacent to the hollow fiber mat layer of the oxygenator module 22 positioned towards the front end 83. A separation grid 62 is inserted between the heat exchanger module 24 and the oxygenator module 22.

[0041] The potting body 80 has an outer surface or periphery 86 which, in various embodiments, is provided with alignment features on the outer surface that coexist with the alignment features of the plurality of hollow fiber mat layers 90 to provide an aligned orientation for the entire oxygenator device 20, as described further below. In embodiments, the alignment features of the potting body 80 include at least one groove extending longitudinally along the outer surface 86 of the potting body 80. For example, in the embodiment of FIG. 6, the alignment features include two diametrically opposed longitudinal grooves 88 that are parallel to the Z-axis. The longitudinal grooves 88 may have a depth of 3 mm to 6 mm. In a preferred embodiment, the longitudinal grooves 88 may be 4 mm deep. FIG. 6 illustrates the potting body 80 after the periphery 86 has been faceted (sliced), which, as described above, opens up the ends of the hollow fibers of the plurality of potted and stacked hollow fiber mat layers 90 (see FIG. 7). The slice should be deep enough to remove the outer layer of polyurethane to expose the open cavities of each of the hollow fibers of the hollow fiber mat layers, allowing fluids (gas mixture and H / C fluid) to circulate inside the hollow fiber cavities. Blood flows around (i.e., outside) the hollow fibers. The slice depth can be in the range of 1 mm to 4 mm. In a preferred embodiment, the slice depth may be about 2 mm.

[0042] In various embodiments, the longitudinal grooves 88 in the potting body 80 define two approximate halves of the potting body 80. In such embodiments, after slicing the periphery 86 of the potting body 80 as described above, the open ends of each of the hollow fibers in the hollow fiber mat layers of the oxygenator device 20 communicate with the respective chambers of the oxygenator device 20. For example, a first half of the oxygenator module 22 includes open fiber ends that communicate with the gas inlet chamber 68 and the open fiber ends at the opposite end (i.e., the hollow fiber ends of the other half) communicate with the gas outlet chamber 72. The hollow fibers in the hollow fiber mat layers of the heat exchanger module 24 are woven in a similar manner, with half of the open fiber ends enclosed in the H / C fluid outlet chamber 70 and the opposite open ends enclosed in the H / C fluid inlet chamber 66. As mentioned above, the four chambers are separated and sealed from each other by two sealing gaskets 56a, 56b and two sealing gaskets 59a, 59b (FIG. 5), located inside the gas collector 78 and the H / C fluid collector 82 and inserted along the groove 88. A suitable sealing arrangement between the four chambers can be obtained not only by gaskets as mentioned above, but also by sealing the chambers by, for example, resin (epoxy or other resin) or any other suitable sealing material.

[0043] The potting body 80 is manufactured by stacking the various elements (i.e., the grids and hollow fiber mat layers of the oxygenator module 22 and the heat exchanger module 24) of the potting body 80 directly into a cylindrical potting mold according to a certain sequence and orientation. As shown in Figs. 7-10, the stacking elements 90 are flat circular layers, the outer diameter of which is equal to the inner diameter of the mold. Each of them has two diametrically opposed grooves 98, which are guided into two corresponding protrusions in the potting mold. First, a layer of blood inlet distribution grid 60 is guided into the mold, and then a plurality of hollow fiber mat layers 90 used for the heat exchanger module 24 are stacked. Next, a layer of separation grid 62 is inserted into the mold, followed by a plurality of hollow fiber mat layers 90 used for the oxygenator module 22, and finally a layer of blood outlet collection grid 64 is inserted. The number of the plurality of stacked hollow fiber mat layers 90 depends on the size of the oxygenator device 20 to be realized. In this case, the filled potting mold together with the polyurethane resin is centrifuged about the vertical Z-axis. After centrifugation, the cylindrical potting body 80 is demolded, sliced ​​(i.e., small faces are formed on its lateral outer surfaces), and assembled with the other parts of the oxygenator device 20 as previously described.

[0044] The multiple hollow fiber mat layers 90 laminated to the potting body 80 will be described in more detail below with reference to Figures 7 to 10. Figure 7 shows an exploded view of some layers of the multiple hollow fiber (HF) mat layers 90 when laminated to a potting mold. The multiple hollow fiber mat layers 90 are circular in shape, and each layer includes multiple threads 92 (also called warp threads) and multiple hollow fibers (HF) 94 parallel to each other. As will be further described with reference to Figure 10, such mat layers are obtained by heat sealing and cutting on their circular periphery.

[0045] In various embodiments, the hollow fibers 94 are microporous hydrophobic membranes made of materials such as, but not limited to, polypropylene or polymethylpentene in the oxygenator module 22 and non-microporous membranes made of polyethylene or polyurethane in the heat exchanger module 24. The microporous hollow fibers 94 in the oxygenator module 22 are configured to allow gas (O2) to diffuse through the pores of the hollow fibers 94 into the blood and vice versa (CO2). In the heat exchanger module 24, the hollow fibers 94 only allow heat transfer between the blood and the H / C fluid (and vice versa). The threads 92 may be made of polyester fibers.

[0046] As shown in FIGS. 7-9, each hollow fiber mat layer 90 includes parallel threads that are all oriented along the X-axis direction, and includes alignment features to form the alignment features of the potting body 80 (for orienting the chambers of the H / C fluid and gas collectors 82 and 78). In the exemplary embodiment of FIGS. 7-9, the alignment features are provided by at least two grooves 98 on either side of each mat layer 90, which are aligned opposite each other and diametrically opposed to each other to define the transverse X-axis. In this manner, the alignment features of each mat layer 90 align along a direction parallel to the direction of the threads 92. The specific location and orientation of the two grooves 98 divides the hollow fibers 94 in each layer into two halves (upper and lower halves), in which each single fiber has one end in the upper half and another end in the lower half. Since there are no "short circuits" of fibers (i.e., two ends located in the same half), the fibers are fully utilized in the exchange process. Once the layers are potted, the grooves 98 form the grooves 88 in the body 80, which also align with the inlet and outlet chambers of the device 20, so that fluid (H / C fluid or gas) enters the fiber cavity at one end and flows along the entire fiber and out the opposite end.

[0047] 7-9 illustrate another feature, namely, that the yarns 92 of each hollow fiber mat layer 90 extend along a transverse axis X, representing the orientation of each of the hollow fiber mat layers 90, but the hollow fibers 94 of each of the hollow fiber mat layers 90 are skewed at an angle relative to the Y axis, where the Y axis is perpendicular to the X axis. Thus, the hollow fibers 94 are positioned in each of the hollow fiber mat layers 90 with the yarns 92 therein parallel to the X axis, but skewed relative to the Y axis, such that they are at an approximate angle relative to the Y axis. In these embodiments, as compared to hollow fiber mat layers 90 positioned adjacent to one another, as shown in FIG. 7, the orientation of the hollow fibers 94 has alternating skew angles, but the orientation of the warp yarns 92 is consistent and parallel to the X axis. This allows the hollow fibers 94 to be cross-oriented, which is very important for maximizing the heat and gas exchange performance of the device 20, while the multiple mat layers 90 are oriented in the direction of the X-axis.

[0048] For example, in FIG. 7, a first hollow fiber mat layer 90a of the plurality of hollow fiber mat layers 90 includes a plurality of threads 92 extending parallel along an X-axis and a plurality of hollow fibers 94 extending in a direction parallel to a W-axis, the W-axis extending at a skew angle α with respect to the Y-axis, where α can be greater than 0 degrees and less than or equal to 25 degrees. In preferred embodiments, the value of the angle α can range from 12.5 degrees to 25 degrees. A second hollow fiber mat layer 90b of the plurality of hollow fiber mat layers 90 is also shown disposed below the first hollow fiber mat layer 90a and having a plurality of threads 92 extending along a transverse axis X and a plurality of hollow fibers 94 extending in a direction generally parallel to a V-axis. In these embodiments, the V-axis forms an angle β with respect to the Y-axis. In embodiments, the angles α and β are on opposite sides of the Y-axis. In various embodiments, the value of the angle β can be greater than 0 degrees and less than or equal to 25 degrees. In a preferred embodiment, the angle β may range from 12.5 degrees to 25 degrees. In a further preferred embodiment, the angle β may be equal to the angle α and opposite in direction to the angle α. For example, the angle α may have a value of 10 degrees and the angle β may have a value of -10 degrees (i.e., in the opposite direction). In this case, the hollow fibers 94 of the first hollow fiber mat layer 90a and the second hollow fiber mat layer 90b adjacent to each other are offset by an angle of about twice the value of α or 2×the value of α (i.e., 20 degrees). In other embodiments, the value of the angle β may be different from the value of the angle α. For example, in some embodiments, the angle α may have a value of 10 degrees and the angle β may have a value of -15 degrees. Also, although the angles α and β are shown to be essentially the same among the layers in the plurality of hollow fiber mat layers 90, their values ​​may be different among the layers in the plurality of hollow fiber mat layers 90.

[0049] The offset between the hollow fibers 94 of adjacent first and second hollow fiber mat layers 90a, 90b can be increased by angling the hollow fibers 94 in opposite directions relative to the Y direction (e.g., W and V directions in FIG. 7). The angle between the hollow fibers 94 in the stacked hollow fiber mat layers 90 is necessary to provide optimized mass transfer between the gas and H / C fluids and the blood flowing through the oxygenator device 20.

[0050] A third hollow fiber mat layer 90c of the plurality of hollow fiber mat layers 90 is disposed below the second hollow fiber mat layer 90b. In the exemplary embodiment of FIG. 7, the third hollow fiber mat layer 90c, like the first hollow fiber mat layer 90a, has a plurality of threads 92 extending along a transverse axis X, a plurality of hollow fibers 94 aligned with a W axis, and an angle between the transverse Y axis and the W axis is α. A fourth hollow fiber mat layer 90d can be positioned below the third hollow fiber mat layer 90c. In the exemplary embodiment of FIG. 7, the fourth hollow fiber mat layer 90d, like the second hollow fiber mat 90b, is guided such that the plurality of threads 92 are parallel to the transverse axis X and the plurality of hollow fibers 94 are approximately parallel to the V axis (at an angle β with Y). In general, the values ​​of angles α and β of 90c and 90d may be different from the corresponding angles of first and second hollow fiber mat layers 90a and 90b.

[0051] Such alternating orientation of the hollow fiber mat layers 90 allows the hollow fibers 94 in each of the hollow fiber mat layers 90 to be oriented at an angle that is typically offset from the orientation of the hollow fibers 94 in an adjacently positioned hollow fiber mat layer 90, while the orientation of the yarns 92 in all stacked hollow fiber mat layers 90 is essentially parallel throughout the device. In the hollow fiber mat layers 90, the hollow fiber mat layers 90a-90d can include one layer or a set of multiple layers (up to 10 layers) of hollow fiber mat layers 90, with each set of layers being characterized in that the hollow fibers 94 are skewed at a different angle with respect to the Y-axis, which is perpendicular to the orientation of all yarns 92 (all yarns are parallel to each other).

[0052] FIG. 8 is a front view of the first (or third) hollow fiber mat layer 90a (or 90c) of FIG. 7, and FIG. 9 is a front view of the second (or fourth) hollow fiber mat layer 90b (or 90d) of FIG. 7. FIGS. 8 and 9 show that the hollow fibers 94 of the first hollow fiber mat layer 90a and the second hollow fiber mat layer 90b have equal skew angles in opposite directions and similar orientation of the threads 92. Each of the hollow fiber mat layers 90 is obtained by annular heat sealing, cutting into the hollow fiber mat layer 90, and separating the circular HF mat layer 90 from the material of the hollow fiber mat layer 90 outside the heat seal area. The outer periphery 96 includes two diametrically opposed grooves 98 parallel to the threads 92, which allow for accurate orientation and alignment of the layers in the potting mold as described above, and can subsequently form the longitudinal grooves 88 in the potting body. Heat sealing can be achieved by known heat sealing equipment or other suitable heat sealing methods.

[0053] FIG. 10 shows the heat sealed hollow fiber mat layer 90e before it is cut and separated from the other mat material (i.e., before it reaches the stage shown in FIG. 8 and FIG. 9). The heat sealed crown area 97 is twice the size of the perimeter 96, and only the perimeter is retained in place after cutting. Typically, the thickness of the heat sealed crown area 97 is 2 mm to 4 mm, preferably 3 mm. Cutting can be done in various ways, such as slicing, press cutting, or any other suitable way. The process can be done on a single mat layer as needed, or on multiple single (or grouped) hollow fiber mat layers 90 together. The hollow fiber mat layers 90 can then be stacked in a potting mold facing each other as shown in FIG. 7. Before the layers can be heat sealed, the hollow fiber mat material needs to be accurately positioned by aligning the threads 92 parallel to the X axis and skewing the hollow fibers 94 at an angle α or β with respect to the Y direction (perpendicular to X). Also, the heat seal grooves 98 must be oriented diametrically opposite each other and parallel to the X-axis. The reason why it is necessary to use heat seal to obtain the layers is that in this way the relative positioning between the hollow fibers 94 and the threads 92 can be maintained (i.e., a skew angle can be formed), and the exact positions of the two grooves 98 can be marked by fixing them in the appropriate positions, allowing the subsequent lamination process in which all the hollow fiber mat layers 90 are aligned with the threads 92 parallel to the first direction, and the hollow fibers 94 in adjacent layers are alternately skewed with respect to the direction perpendicular to the first direction. In short, the skew offset between the hollow fibers 94 in the different hollow fiber mat layers 90 provided sufficient cross-orientation between the hollow fibers so that the lamination process can be completed without the need for any rotation of the hollow fiber mat layers 90, which skew offset is provided by the specific forming process of each layer 90 described above. This is important to increase ease of assembly of the oxygenator device 20 (which is easily automated) while improving heat and gas transfer efficiency, and reducing the potential for manufacturing variations.

[0054] Although the oxygenator module 22 has been shown in the embodiments thus far as being stacked adjacent to the heat exchanger module 24, the two modules do not have any rotational angle relative to each other. Various other embodiments are possible, for example, in which the oxygenator module 22 and the heat exchanger module 24 are stacked adjacent to each other, but rotated at an angle about the Z axis. This angle can have a value ranging from 0 degrees (as shown in FIGS. 2-6) to 90 degrees. In such an embodiment, the potting body 80 is molded in two steps to accommodate the offset positioning of the heat exchanger module 24 and the oxygenator module 22, eliminating the need to stack them parallel to each other. Additionally, the orientations of the H / C fluid inlet chamber 66 and H / C fluid outlet chamber 70 and the gas inlet chamber 68 and gas outlet chamber 72 are correspondingly rotated to maintain communication with the corresponding halves of the hollow fiber ends in the oxygenator module 22 and the heat exchanger module 24. Also, other embodiments are possible in which the heat exchanger module 24 is absent and the device 20 includes only the oxygenator module 22 .

[0055] In the above description, many features and advantages have been described, including details of the structure and function of various alternative means and devices and / or methods. Also, the scope of the invention of various concepts proposed in the present disclosure has been described with general and specific examples. The present disclosure is illustrative only and is not exhaustive. For example, various embodiments of the present disclosure have been described in the context of medical applications, but may be used in non-medical applications. As will be apparent to those skilled in the art, various modifications may be made, particularly in terms of structure, materials, elements, parts, shapes, sizes, and part arrangements (including combinations within the principles of the present invention), to embody all the contents set forth in the broad and general sense of the appended claims. These various modifications are intended to be included within the scope of the appended claims, unless they depart from the substance and scope of the appended claims.

Claims

1. 1. An oxygen supply device for use in conjunction with extracorporeal blood circulation, comprising: a potting body having a first alignment feature defining an alignment axis; an oxygenator module comprising a plurality of circular hollow fiber mat layers, the plurality of circular hollow fiber mat layers comprising second alignment features configured to align with the first alignment feature of the potting body to define an orientation of each of the plurality of hollow fiber mat layers relative to the alignment axis; a heat exchanger module comprising at least two of the plurality of circular hollow fiber mat layers; a blood inlet positioned adjacent a first end of the potting body; a blood outlet positioned adjacent a second end of the potting body opposite the first end; a gas inlet and a gas outlet configured to direct a gas mixture through the plurality of hollow fibers of the plurality of hollow fiber mat layers; a fluid inlet and a fluid outlet configured to supply and discharge H / C fluid through a portion of the potting body; a first layer of the plurality of hollow fiber mat layers includes a first plurality of parallel hollow fibers inclined at a first angle with respect to a direction perpendicular to the alignment axis, and a second layer of the plurality of hollow fiber mat layers includes a second plurality of parallel hollow fibers inclined at a second angle with respect to a direction perpendicular to the alignment axis, one of the first plurality of parallel hollow fibers and the second plurality of parallel hollow fibers having a positive inclination with respect to a line perpendicular to the alignment axis and the other having a negative inclination; The potting body further comprises a distribution grid disposed between the blood inlet and the heat exchanger module, the distribution grid being a perforated circular structure configured to distribute blood flow toward the heat exchanger module. the potting body further comprises a separation grid disposed between the heat exchanger module and the oxygenator module, the separation grid being a perforated circular structure arranged to separate blood flow toward the oxygenator module; The oxygenator, wherein the potting body further comprises a collection grid disposed between the oxygenator module and the blood outlet, the collection grid being a perforated circular structure configured to collect blood flowing from the oxygenator module toward the blood outlet.

2. The apparatus of claim 1 , wherein the gas mixture is configured to pass through the at least two of the plurality of hollow fiber mat layers in the oxygenator module.

3. The apparatus of claim 1 , wherein the H / C fluid is configured to pass through the at least two of the plurality of hollow fiber mat layers in the heat exchanger module.

4. 10. The apparatus of claim 1, further comprising a first case portion disposed proximate the first end of the potting body and a second case portion positioned proximate the second end of the potting body.

5. The apparatus of claim 1 , wherein each of the plurality of hollow fiber mat layers includes a plurality of threads coupled to the plurality of hollow fibers.

6. The apparatus of claim 5 , wherein the plurality of threads are arranged at a non-orthogonal angle to the arrangement of the plurality of hollow fibers.

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