Hollow fiber apparatus for extracorporeal blood circulation

Abstract

An apparatus for extracorporeal blood circulation is provided, comprising: a potting having an oxygenator module comprising at least two of a plurality of circular hollow fiber mats; a heat exchanger module comprising at least two of the plurality of circular hollow fiber mats; a blood inlet adjacent a first end of the potting; and a blood outlet adjacent a second end of the potting. The apparatus includes 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 comprises a plurality of hollow fibers aligned in a direction angled relative to an 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 the same orientation to each other.

Description

Technical Field

[0001] This disclosure relates to the field of devices for extracorporeal blood circulation. More specifically, this disclosure relates to extracorporeal blood oxygenators and components thereof, such as oxygenators and heat exchangers. Background Technology

[0002] Devices for extracorporeal blood circulation may include two parts: an oxygenator and a heat exchanger, for exchanging O2 and CO2 between a blood and gas mixture and heat between the blood and a heating or cooling fluid through the walls of a semi-permeable hollow fiber membrane. As the gas mixture and the heating / cooling fluid (aqueous solution) circulate within the hollow fiber cavity, the blood contacts the outer surface of the hollow fibers. In devices using this technology, the hollow fibers can be organized in various ways. They may be in the form of monofilaments or multifilaments woven around a core, or they may be constructed as pads wound around a core, or stacked in layers of pads (without a core). Various examples of this technology are well known in the art.

[0003] There is still a need for a blood extracorporeal circulation device that can potentially reduce the high blood pressure drop that damages blood cells, as well as a device that reduces the formation of blood clots while enabling a simple formation and manufacturing process. Summary of the Invention

[0004] Embodiments of the present invention include: an oxygenation hollow fiber membrane organized in stacked hollow fiber pads, the structure of which is specifically conceived to provide higher gas exchange efficiency and better oxygenation effect; a method for preparing the hollow fiber membrane; and an oxygenation assembly manufactured using the more easily manufactured hollow fiber membrane.

[0005] According to one example (“Example 1”), an oxygenation device for use in conjunction with extracorporeal blood circulation includes: a potting body including a first alignment feature defining an alignment axis; an oxygenator module including a plurality of circular hollow fiber pads, the plurality of circular hollow fiber pads including a second alignment feature configured to align with the first alignment feature of the potting body such that each of the plurality of hollow fiber pads is oriented relative to the alignment axis; a heat exchanger module including at least two of the plurality of circular hollow fiber pads; a blood inlet near a first end of the potting body; and a blood outlet near a second end of the potting body opposite the first end. The device further includes: a gas inlet and a gas outlet configured to guide a gas mixture through the plurality of hollow fibers of the plurality of hollow fiber pads; and a fluid inlet and a fluid outlet for H / C fluid to enter and exit a portion of the potting body. The device also includes a first layer of a plurality of hollow fiber pads comprising a first plurality of parallel hollow fibers arranged at a first angle relative to a direction orthogonal to the alignment axis, and a second layer of a plurality of hollow fiber pads comprising a second plurality of parallel hollow fibers arranged at a second angle relative to a direction orthogonal to the alignment axis, the first angle and the second angle being arranged on opposite sides of the direction orthogonal to the alignment axis.

[0006] According to the second example (“Example 2”), the device of Example 1 includes at least two of a plurality of hollow fiber pads in an oxygenator module through which a gas mixture passes.

[0007] According to the third example (“Example 3”), the device of Example 1 includes at least two of a plurality of hollow fiber pads through which H / C fluid passes through a heat exchanger module.

[0008] According to the fourth example (“Example 4”), the device of Example 1 includes a blood distribution grid between the blood inlet and the heat exchanger module, wherein the potting body also includes a blood distribution grid between the blood inlet and the heat exchanger module.

[0009] According to the fifth example (“Example 5”), the device of Example 1 includes a blood separation grid between a heat exchanger module and an oxygenator module, wherein the potting body further includes a blood separation grid between the heat exchanger module and the oxygenator module.

[0010] According to the sixth example (“Example 6”), the device of Example 1 includes a blood collection grid between the oxygenator module and the blood outlet, wherein the potting body further includes a blood collection grid between the oxygenator module and the blood outlet.

[0011] According to the seventh example (“Example 7”), the device of Example 1 includes a first housing adjacent to a first end of the potting compound and a second housing adjacent to a second end of the potting compound.

[0012] According to the eighth example (“Example 8”), the device of Example 1 includes a plurality of hollow fiber pads, each including a plurality of wires coupled to a plurality of hollow fibers.

[0013] According to the ninth example (“Example 9”), the device described in Example 8, wherein the plurality of wires are arranged at angles not orthogonal to the arrangement of the plurality of hollow fibers.

[0014] According to the tenth example (“Example 10”), an assembly of multiple hollow fiber pads for an extracorporeal blood circulation device includes a first hollow fiber pad and a second hollow fiber pad positioned adjacent to each other, each of the first and second hollow fiber pads including a plurality of parallel lines and a plurality of parallel hollow fibers. The assembly further includes multiple lines of the first and second hollow fiber pads positioned parallel to an alignment axis, and multiple hollow fibers of the first hollow fiber pad parallel to a second axis intersecting the alignment axis at a first angle, and multiple hollow fibers of the second hollow fiber pad parallel to a third axis intersecting the alignment axis at a second angle and positioned on the side of the alignment axis opposite to the first angle.

[0015] According to the eleventh example (“Example 11”), the components of Example 10 include a first hollow fiber pad and a second hollow fiber pad, both of which are circular in shape.

[0016] According to the twelfth example (“Example 12”), the components of Example 10 include a second axis at an angle between 0 and 50 degrees relative to a third axis.

[0017] According to the thirteenth example (“Example 13”), the component of Example 12 includes each of a plurality of hollow fiber pads comprising at least two grooves that are aligned with at least two grooves of hollow fiber pads positioned adjacent to each other.

[0018] According to Example 14 (“Example 14”), the components of Example 13 include a plurality of hollow fiber pads, each of which is aligned to have the same orientation as each other.

[0019] According to Example 15 (“Example 15”), the components of Example 12 also include a plurality of hollow fiber pads including a third hollow fiber pad positioned directly below a second hollow fiber pad, and a fourth hollow fiber pad positioned directly below the third hollow fiber pad.

[0020] According to the sixteenth example (“Example 16”), the components of Example 15 also include a plurality of hollow fibers of the third hollow fiber pad aligned along the second axis, and a plurality of hollow fibers of the fourth hollow fiber pad aligned with the third axis.

[0021] According to Example 17 (“Example 17”), an oxygenation device for use in conjunction with extracorporeal blood circulation includes: a filling body including a blood inlet disposed near a first end and a blood outlet disposed near a second end opposite to the first end; and a lateral outer surface including a first alignment feature defining an alignment axis. The device also includes an oxygenator module comprising a plurality of circular hollow fiber pads, each comprising a plurality of hollow fibers coupled to a plurality of wires, and each layer including a second alignment feature configured to align with the first alignment feature of the filling body such that each of the plurality of hollow fiber pads is oriented relative to the alignment axis. The device also includes a gas inlet configured to supply a gas mixture to the plurality of hollow fibers, wherein a first layer of the plurality of hollow fiber pads includes a first plurality of parallel hollow fibers intersecting the alignment axis at a first angle, and a second layer of the plurality of hollow fiber pads adjacent to the first layer includes a second plurality of parallel hollow fibers intersecting the alignment axis at a second angle, the first angle and the second angle being located on opposite sides of the alignment axis.

[0022] According to the eighteenth example (“Example 18”), the device of Example 17 also includes a first angle and a second angle that are symmetrical with respect to the alignment axis.

[0023] According to the nineteenth example (“Example 19”), the device of Example 17 also includes a first angle and a second angle, each of which is between 0 degrees and 25 degrees.

[0024] According to the twentieth example (“Example 20”), the device of Example 19 also includes a plurality of lines arranged at an angle not orthogonal to the arrangement of the plurality of hollow fibers in each hollow fiber pad.

[0025] Although several embodiments have been disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description of the exemplary embodiments shown and described. Therefore, the accompanying drawings and detailed description should be considered illustrative rather than restrictive in nature. Attached Figure Description

[0026] This document includes accompanying drawings to further illustrate the invention. The drawings are incorporated in and form a part of this specification and illustrate embodiments, and together with the description serve to explain the principles of this disclosure.

[0027] Figure 1 This is a diagram illustrating a patient undergoing extracorporeal blood circulation.

[0028] Figure 2 This is a schematic front view of an oxygenator apparatus according to some embodiments of this disclosure.

[0029] Figure 3 It is from the implementation scheme disclosed herein. Figure 2 Left view of the oxygenator unit.

[0030] Figure 4 It is an oxygenator equipment along Figure 2 The transverse section intercepted by line AA,

[0031] Figure 5 It is based on the implementation scheme of this disclosure. Figure 2 Exploded view of the oxygenator unit.

[0032] Figure 6 It is based on the implementation scheme of this disclosure. Figure 2 Perspective view of the potting compound of the oxygenator equipment.

[0033] Figure 7 It is produced by stacking multiple hollow fiber pads in a potting mold according to an embodiment of this disclosure. Figure 6 Exploded view of the potting compound before filling.

[0034] Figure 8 The embodiments according to this disclosure are shown. Figure 7 The first hollow fiber pad, consisting of multiple hollow fiber pads,

[0035] Figure 9 The embodiments according to this disclosure are shown. Figure 7 The second hollow fiber pad, consisting of multiple hollow fiber pads, and,

[0036] Figure 10 An embodiment according to this disclosure is shown. Figure 7 One of the multiple hollow fiber pads before it is cut. Detailed Implementation

[0037] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings mentioned herein are not necessarily drawn to scale but may be exaggerated to illustrate various aspects of this disclosure, and in this respect, the drawings should not be construed as limiting.

[0038] Figure 1This is a schematic diagram of a system including a patient 10 requiring extracorporeal blood circulation. In these embodiments, the patient 10 is connected to an extracorporeal blood circulation device 20 (which is also generally referred to herein as an oxygenator device 20) via a first conduit 12, allowing blood to be delivered from the patient 10 to the oxygenator device 20 through the first conduit 12. The oxygenator device 20 includes a second conduit 14 extending from the oxygenator device 20 to the patient 10 for returning blood already circulating within the device 20 to the patient 10. In these embodiments, O2 and CO2 are exchanged within the oxygenator device 20 between the blood and the gas mixture, as will be further described herein. The oxygenator device 20 is also configured to exchange energy (heating or cooling) between the blood and a heating / cooling (H / C) fluid within the oxygenator device 20. In some embodiments, the H / C fluid is water or an aqueous solution.

[0039] Figure 2 This is a front view of an 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 includes: 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 H / C fluid, an H / C fluid outlet 36 for outputting H / C fluid, and a receiver for receiving fluid from a patient 10 (…). Figure 1 The oxygenator device 20 includes a blood inlet 38 and a blood outlet (not shown) for returning blood from the oxygenator device 20 to the patient 10. The oxygenator device 20 also includes a venous sampling port 44 and a first purification port 42a, as will be referred to in... Figure 3 Further described. In some embodiments, the oxygenator device 20 additionally includes a support attachment 46 to allow attachment and rotation of the oxygenator device 20.

[0040] Figure 3 This 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. 52 includes a blood inlet end cap 56, which has a blood inlet end cap configured for supplying blood from a first conduit 12 ( Figure 1 The blood inlet 38 receives blood, and the rear portion 54 includes a blood outlet end cap 58 having a function to provide an outlet for blood to pass through a second conduit 14. Figure 1 Return to patient 10 ( Figure 1 The blood outlet is 40. Additionally, such as... Figure 3As shown, the oxygenator device 20 includes a gas inlet 30 located on a side surface of the oxygenator device 20. The oxygenator device 20 further includes a plurality of purge ports 42, including at least a first purge port 42a and a second purge port 42b. Purge ports 42a and 42b allow air removal during the initial perfusion phase before the oxygenator device 20 is used on a patient. During operation, i.e., while blood and gas flow through the device 20, purge ports 42a and 42b can be reopened to remove entrained air from the blood. Additionally, purge ports 42a and 42b can be opened after operation of the device 20, i.e., when blood is no longer flowing through the device 20, to ensure that any blood is properly evacuated from the device 20 and returned to the patient. The oxygenator device 20 also includes a base 59 positioned on the bottom surface of the device 20 for supporting and stabilizing the device 20.

[0041] As referenced above Figure 2 The oxygenator device 20 includes a front portion 52 and a rear portion 54. In these embodiments and as described above... Figure 3 As shown, 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.

[0042] Figure 4 It is an oxygenator device 20. Figure 2 The transverse section intercepted by line AA. Figure 4In an exemplary embodiment, the oxygenator device 20 includes an oxygenator module 22 and a heat exchanger module 24 positioned adjacent to the oxygenator module 22. Both modules 22 and 24 are provided with hollow fiber pads stacked vertically adjacent to each other. The heat exchanger module 24 abuts a blood inlet distribution grid 60 on its right side facing the front portion 52 of the oxygenator device 20. The blood inlet distribution grid 60 receives blood entering from the blood inlet 38 and distributes the blood within itself before it flows into the heat exchanger module 24. The heat exchanger module 24 abuts a separation grid 62 on its left side facing the rear portion 54. This separation grid provides physical separation between the oxygenator module 22 and the heat exchanger module 24 and distributes blood flowing through the heat exchanger module 24 toward the oxygenator module 22. Thus, the heat exchanger module 24 is located on the opposite side of the separation grid 62 relative to the oxygenator module 22, with the oxygenator module further positioned toward the rear portion 54 of the oxygenator device 20. The heat exchanger module 24 is vertically positioned below the H / C fluid inlet chamber 66 and above the base 59 and the H / C fluid outlet chamber 70. The oxygenator module 22 also has a blood outlet collection grille 64 adjacent to the rear portion 54 of the oxygenator device 20 on its left side; this blood outlet collection grille is configured to collect blood flowing from the oxygenator module 22 before it exits through the blood outlet 40. As shown, the gas inlet chamber 68 and the support attachment 46 are vertically positioned above the oxygenator module 22. The gas outlet chamber 72 is vertically positioned below the oxygenator module 22.

[0043] Thus, each of the oxygenator module 22 and the heat exchanger module 24 typically comprises two sections or two halves. As will be further described below, the oxygenator module 22 has a section configured to communicate with a gas inlet chamber 68 and a section configured to communicate with a gas outlet chamber 72. Similarly, the heat exchanger module 24 has a section configured to communicate with an H / C fluid inlet chamber 66 and a section configured to communicate with an H / C fluid outlet chamber 70. As shown, the front portion 52 of the oxygenator device 20 includes a blood inlet 38, and the rear portion 54 of the oxygenator device 20 includes a blood outlet 40. Due to this configuration, when blood is driven through both the heat exchanger module 24 and the oxygenator module 22 to flow from the blood inlet 38 to the blood outlet 40, the blood is able to contact the fluid mixture and the gas (by inserting suitable hollow fiber membranes in the heat exchanger module 24 and the oxygenator module 22) to achieve adequate heat and gas exchange.

[0044] Figure 5This is an exploded view of the oxygenator device 20, showing the component assemblies within the oxygenator device 20. Referring to this figure, the oxygenator device 20 includes a blood path comprising a blood inlet end cap 56 having a blood inlet 38 and a purification port 42a, a potting body 80, and a blood outlet end cap 58 having 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, these components being embedded together in a single (potting) piece. The hollow fiber openings on the outer surface of the potting body allow H / C fluid and gas to enter the cavities of the heat exchanger 24 and the oxygenator 22.

[0045] The blood inlet end cap 56 is provided with a plurality of peripheral cavities 74, which are mechanically fitted into corresponding peripheral recesses 61 on the blood inlet dispensing grid 60 of the potting body 80. Airtightness between the blood inlet end cap 56 and the blood inlet dispensing grid 60 is achieved by resin casting along the two circular contact surfaces of the blood inlet end cap 56 and the blood inlet dispensing grid 60. Similarly, at the opposite end of the potting body 80, the blood outlet end cap 58 includes a plurality of peripheral cavities 76, which are mechanically fitted into corresponding peripheral recesses 65 on the outlet collection grid 64 of the potting body 80. Airtightness between the blood outlet end cap 58 and the outlet collection grid 64 is achieved by resin casting along the circular contact surfaces of the blood outlet end cap 58 and the outlet collection grid 64. In this manner, the entire blood chamber, including the blood inlet end cap 56, the blood outlet end cap 58, and the potting body 80, is joined in a single airtight component.

[0046] Blood enters the oxygenator device 20 through the blood inlet 38 of the blood inlet end cap 56, passes through the blood inlet distribution grid 60, the stacked hollow fiber pads forming the heat exchanger module 24, the separation grid 62, the stacked hollow fiber pads forming the oxygenator 22, and the outlet collection grid 64, reaching the blood outlet 40 of the blood outlet end cap 58. The blood inlet distribution grid 60, separation grid 62, and outlet collection grid 64 are circular plastic components with relatively large holes (from 1 mm to 8 mm) penetrating 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 through them is evenly distributed. The remainder of the device 20 includes an outer housing surrounding the H / C fluid chamber and the gas chamber, namely the H / C fluid collector 82 (including the H / C fluid inlet 34 and the H / C fluid outlet 36) and the gas collector 78 (including the gas inlet 30 and the gas outlet 32, as shown in the image). Figure 2 As shown, it also includes a bracket accessory 46 and a base 59.

[0047] 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 is assembled to the blood inlet end cap 56 by resin casting 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 sealing gaskets 56a and 56b, namely, the H / C fluid inlet chamber 66 and the H / C fluid outlet chamber 70. Figure 4 As shown in the diagram, the two sealing gaskets are inserted along two alignment features, which are exemplified as two longitudinal grooves 88 that are diametrically opposed. Figure 6 (As shown in the figure), it exists on the outer surface of the potting body 80. The H / C fluid flows through the gap between the inner surface of the H / C fluid collector 82 and the outer surface of the potting body 80 inside the H / C fluid chamber to (and out of) the heat exchanger module 24, thereby forming the H / C fluid inlet chamber 66 and the H / C fluid outlet chamber 70.

[0048] Similarly, the gas collector 78 is externally positioned relative to the outer surface of the oxygenator module 22 and the potting body 80, and is assembled to the blood outlet end cap 58 by resin casting 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 near the H / C fluid collector 82, corresponding to the separation grid 62, and is airtightly joined to the potting body 80 by resin casting. In this way, the gas chamber is completely airtight. Furthermore, the gas chamber is divided into two halves by two sealing gaskets 59a and 59b: a gas inlet chamber 68 and a gas outlet chamber 72. Figure 4 (as shown in the diagram), these sealing gaskets are inserted along two alignment features, which are exemplified as two diametrically opposed longitudinal grooves 88 provided on the outer surface of the potting body 80 (according to...). Figure 6 Gas flows into (and out of) the oxygenator module 22 through the gas chamber formed by the gap between the inner surface of the gas collector 78 and the outer surface of the potting body 80, forming a gas inlet chamber 68 and a gas outlet chamber 72.

[0049] Figure 6 This is a perspective view of the potting body 80 of the oxygenator device 20 after demolding from the potting mold and faceting to form the lateral outer surface 86 of the potting body 80. This lateral outer surface provides the potting body with a multifaceted polygonal shape extending along the Z-axis and opening the ends of the hollow fibers of the two modules 22 and 24, thereby providing passage to the cavities of these two modules for the circulation of H / C fluid and gas. Line 84 indicates some of the faces obtained by faceting. The potting body 80, pre-filled with multiple hollow fiber pads 90, is formed by high-speed centrifugation around the Z-axis of a cylindrical potting mold. Figure 7 As shown in the diagram, these hollow fiber pads are stacked layer by layer to form both the heat exchanger module 24 and the oxygenator module 22. A certain amount of resin (typically polyurethane, initially liquid) is injected into a rotating mold and pressed against the mold wall by centrifugal force. The difference between the outer diameter 89 and the inner diameter 87 of the potting compound is typically in the range of 7 mm to 10 mm (preferably 8 mm). The outer diameter 89 can be between 7 cm and 18 cm, and in a preferred embodiment, is 12 cm. Thus, the potting compound 80 provides a large and unobstructed internal channel for blood flow, thereby providing the oxygenator device 20 with the benefit of a significant reduction in blood pressure drop. The potting compound 80 includes a rear end 81 and a front end 83. The hollow fiber pads of the heat exchanger module 24 are positioned toward the rear end 81, and are stacked adjacent to the hollow fiber pads of the oxygenator module 22 positioned toward the front end 83. A separation grid 62 is inserted between the heat exchanger module 24 and the oxygenator module 22.

[0050] The potting body 80 has an outer surface or periphery 86, which, in various embodiments, is provided with alignment features that coexist with alignment features of a plurality of hollow fiber pads 90 to impart an alignment orientation to the entire oxygenator device 20, as will be further described. 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 Figure 6 In one embodiment, the alignment feature includes two longitudinal grooves 88 parallel to the Z-axis and diametrically opposed. The longitudinal grooves 88 may have a depth of 3 mm to 6 mm. In a preferred embodiment, the depth of the longitudinal grooves 88 may be 4 mm. Figure 6 The image shows the potting compound 80 after the outer periphery 86 has been faceted (sliced), as explained, this results in the ends of the hollow fibers of the multiple potted and stacked hollow fiber pads 90 being opened (according to...). Figure 7 The slice must be deep enough to remove the polyurethane outer layer and expose the end face through-holes of each of the multiple hollow fibers in the multiple hollow fiber pads to allow fluid (gas mixtures and H / C fluids) to flow inside the hollow fiber lumen. Blood flows around the hollow fibers (i.e., on their outside). The slice depth can range from 1 mm to 4 mm. In a preferred embodiment, the slice depth can be approximately 2 mm.

[0051] In various embodiments, the longitudinal grooves 88 of the potting body 80 create two generally half portions of the potting body 80. In such embodiments, after slicing the outer periphery 86 of the potting body 80, the open end of each of the multiple hollow fibers of the multiple hollow fiber pads of the oxygenator device 20 communicates with the respective chambers of the oxygenator device 20, as previously described. For example, the first half of the oxygenator module 22 includes an open hollow fiber terminal communicating with the gas inlet chamber 68, while an open hollow fiber terminal at its opposite end (i.e., the other half of the hollow fiber terminal) communicates with the gas outlet chamber 72. The multiple hollow fibers of the multiple hollow fiber pads of the heat exchanger module 24 are similarly organized, with half of the open hollow fiber terminals closed within the H / C fluid outlet chamber 70, and their opposite open ends closed within the H / C fluid inlet chamber 66. As described above, these four chambers utilize two sealing gaskets 56a, 56b and two sealing gaskets 59a, 59b ( Figure 5 The chambers are separated and sealed from each other, located inside the gas collector 78 and the H / C fluid collector 82, and inserted along the groove 88. A suitable sealing device between the four chambers can be obtained not only by gaskets as described above, but also, for example, by sealing these chambers with resin (epoxy or other resins) or any other suitable sealing material.

[0052] The potting compound is manufactured by directly stacking the various components of the potting compound 80 (i.e., the grid and hollow fiber pad of the oxygenator module 22 and the heat exchanger module 24) into a cylindrical potting mold in a specific order and orientation. Figures 7 to 10 As shown, the components 90 to be stacked are flat, circular layers with an outer diameter equal to the inner diameter of the mold. Each of them has two grooves 98 diametrically opposed, which will be introduced into two corresponding protrusions in the filling mold. The layer of blood inlet dispensing grid 60 is first introduced into the mold, followed by the stacking of multiple hollow fiber pad layers 90 for the heat exchanger module 24. Next, the layer of separation grid 62 is inserted into the mold, followed by the stacking of multiple hollow fiber pad layers 90 for the oxygenator module 22, and finally the layer of blood outlet collection grid 64 is inserted. The number of multiple stacked hollow fiber pad layers 90 depends on the size of the oxygenator device 20 to be implemented. At this point, the filled filling mold is further centrifuged along with polyurethane resin around the longitudinal Z-axis. After centrifugation, the cylindrical filling body 80 is demolded, cut (i.e., facets are formed on its laterally outward surfaces), and assembled with the other parts of the oxygenator device 20 as already described.

[0053] The following will refer to Figures 7 to 10 The multiple hollow fiber pads 90 stacked into the potting compound 80 are described in further detail. Figure 7An exploded view of some layers of a plurality of hollow fiber (HF) pads 90 as stacked into a potting mold is shown. The plurality of hollow fiber pads 90 are circular in shape, and each layer comprises multiple strands 92 (also referred to as warp threads) and multiple hollow fibers (HF) 94 parallel to each other. These pads are obtained by heat-sealing and cutting their circular outer peripheries, as will be shown in reference. Figure 10 Further description.

[0054] In various embodiments, the hollow fibers 94 in the oxygenator module 22 are microporous hydrophobic membranes made of materials such as, but not limited to, polypropylene or polymethylpentene, and in the heat exchanger module 24 are non-microporous membranes made of polyethylene or polyurethane. The multiple microporous hollow fibers 94 of the oxygenator module 22 are configured such that they allow gas to diffuse through the pores of the hollow fibers 94 into the blood (O2) and vice versa (CO2). In the heat exchanger module 24, the multiple hollow fibers 94 allow only heat transfer between the blood and the H / C fluid (and vice versa). The multiple wires 92 may be made of polyester fibers.

[0055] like Figures 7 to 9 As shown, each hollow fiber pad 90 includes multiple parallel lines oriented entirely along the X-axis and includes alignment features to create alignment features for orienting the chambers of the H / C fluid and gas collectors 82 and 78. Figures 7 to 9 In an exemplary embodiment, alignment features are provided by at least two grooves 98 on either side of each pad 90, these two grooves being aligned opposite each other and diametrically opposed to define a transverse X-axis. In this way, the alignment features of each pad 90 are aligned in a direction parallel to the direction of the plurality of lines 92. The specific location and orientation of the two grooves 98 such that the plurality of hollow fibers 94 in each layer are divided into two halves (upper and lower halves), with each individual fiber having one end in the upper half and another end in the lower half. There is no fiber “short-circuiting” (i.e., both ends located in the same half), thus the fibers are fully utilized during exchange. Fluid (H / C fluid or gas) enters the fiber cavity at one end, flows along the entire fiber, and exits at the opposite end, as the grooves 98 create grooves 88 in the potting body 80 once the layer is potted, which align the inlet and outlet chambers of the device 20.

[0056] Figures 7 to 9Another characteristic is illustrated: while the multiple lines 92 of each hollow fiber pad 90 extend along the transverse axis X, indicating the orientation of each of the multiple hollow fiber pads 90, the multiple hollow fibers 94 of each of the multiple hollow fiber pads 90 are tilted at an angle relative to the Y-axis, where the Y-axis is orthogonal to the X-axis. Therefore, the multiple hollow fibers 94 are positioned on each of the multiple hollow fiber pads 90 with their lines 92 parallel to the X-axis, but tilted relative to the Y-axis such that their orientation relative to the Y-axis is approximately at an angle. In these embodiments, as... Figure 7 As shown, compared to the adjacent hollow fiber pads 90, the multiple hollow fibers 94 have alternating tilt angles, while the multiple warp threads 92 are aligned and parallel to the X-axis. This creates a cross-orientation of the hollow fibers 94, which is crucial for maximizing the heat exchange and gas exchange performance of the device 20, depending on the orientation of the multiple pads 90 along the X-axis.

[0057] For example, in Figure 7 In this embodiment, a first hollow fiber pad 90a of a plurality of hollow fiber pads 90 includes a plurality of lines 92 extending parallel to the X-axis and a plurality of hollow fibers 94 extending in a direction parallel to the W-axis, the W-axis extending at an angle α relative to the Y-axis, where α can be greater than 0 degrees up to 25 degrees. In a preferred embodiment, the value of angle α can range from 12.5 degrees to 25 degrees. Furthermore, a second hollow fiber pad 90b of the plurality of hollow fiber pads 90 is placed below the first hollow fiber pad 90a and is shown having a plurality of lines 92 extending along the transverse axis X and a plurality of hollow fibers 94 extending in a direction generally parallel to the V-axis. In these embodiments, the V-axis forms an angle β relative to the Y-axis. In embodiments, angles α and β are positioned on opposite sides of the Y-axis. In various embodiments, the value of angle β can be greater than 0 degrees up to 25 degrees. In a preferred embodiment, the range of angle β can be from 12.5 degrees to 25 degrees. In a further preferred embodiment, the value of angle β can be equal to angle α and the direction is opposite to angle α. For example, angle α may have a value of 10 degrees, while angle β may have a value of -10 degrees (i.e., in opposite directions). In this case, the multiple hollow fibers 94 of each adjacent first hollow fiber pad 90a and second hollow fiber pad 90b are offset by an angle approximately twice the value of α, i.e., 2 × α (i.e., 20 degrees). In another embodiment, the value of angle β may differ from the value of angle α. For example, in some embodiments, angle α may have a value of 10 degrees, while angle β may have a value of -15 degrees. Furthermore, although angles α and β are shown as substantially the same between the layers in the plurality of hollow fiber pads 90, their values ​​may also differ between the layers in the plurality of hollow fiber pads 90.

[0058] The hollow fibers 94 of the adjacent first hollow fiber pad 90a and second hollow fiber pad 90b are in opposite directions relative to direction Y (e.g., Figure 7 The angle between W and V in the stacked hollow fiber pads 90 allows for increased offset between the hollow fibers 94 of adjacent hollow fiber pads 90. The angle between the multiple hollow fibers 94 in the stacked hollow fiber pads 90 is necessary to provide optimized delivery of gas and H / C fluids to the blood flowing through the oxygenator device 20.

[0059] A third hollow fiber pad 90c of a plurality of hollow fiber pads 90 is placed below a second hollow fiber pad 90b. Figure 7 In an exemplary embodiment, the third hollow fiber pad 90c is identical to the first hollow fiber pad 90a, such that it has multiple lines 92 extending along the horizontal axis X, multiple hollow fibers 94 aligned with the W axis, and an angle α between the vertical Y axis and the W axis. Furthermore, a fourth hollow fiber pad 90d may be positioned below the third hollow fiber pad 90c. Figure 7 In an exemplary embodiment, the fourth hollow fiber pad 90d is identical to the second hollow fiber pad 90b, such that multiple lines 92 are parallel to the transverse axis X, and multiple hollow fibers 94 are guided approximately parallel to the V-axis (at an angle β to Y). Typically, the values ​​of degree α and angle β of 90c and 90d may also differ from the corresponding angles of the first hollow fiber pad 90a and the second hollow fiber pad 90b.

[0060] This alternating orientation among the multiple hollow fiber pads 90 allows the multiple hollow fibers 94 in each of the multiple hollow fiber pads 90 to be oriented at an angle that is generally offset from the orientation of the multiple hollow fibers 94 in adjacent positioned hollow fiber pads 90, while the orientation of the multiple lines 92 in all stacked hollow fiber pads 90 remains substantially parallel throughout the device. Among the multiple hollow fiber pads 90, hollow fiber pads 90a-d may comprise one or a group of multiple layers (up to 10 layers) of hollow fiber pads 90, each group of layers characterized in that the hollow fibers 94 are tilted at different angles relative to a Y-axis orthogonal to the orientation of the multiple lines 92 (all lines are parallel).

[0061] Figure 8 yes Figure 7 Front view of the first (or third) hollow fiber pad 90a (or 90c), Figure 9 yes Figure 7 Front view of the second (or fourth) hollow fiber pad 90b (or 90d). Figure 8 and Figure 9The diagram shows the equal tilt angles of the hollow fibers 94 in opposite directions and the equal orientation of the multiple lines 92 in the first hollow fiber pad 90a and the second hollow fiber pad 90b. Each of the plurality of hollow fiber pads 90 is obtained by annular heat sealing, cutting the hollow fiber pads 90, and separating the circular HF pads 90 from the hollow fiber pad material outside the heat-sealed area. The outer periphery 96 includes two diametrically opposed grooves 98 parallel to the multiple lines 92, which, as explained, allow the layers to be properly oriented and aligned in the potting mold and subsequently create longitudinal grooves 88 in the potting body. Heat sealing can be achieved using conventional heat sealing machines or other suitable heat sealing methods.

[0062] Figure 10 This shows the process before it is cut and separated from other pad materials (i.e., upon arrival). Figure 8 and Figure 9 The heat-sealed hollow fiber pad 90e (before the stage shown) is heat-sealed. The heat-sealed crown region 97 is twice the size of the outer periphery 96, and only this outer periphery remains in place after cutting. Typically, the heat-sealed crown region is 2 mm to 4 mm thick, preferably 3 mm. Cutting can be performed in various ways, such as cutting, punching, or any other suitable method. This process can be performed on individual pads or together on many individual (or grouped) hollow fiber pads 90, as needed. The hollow fiber pads 90 can then be... Figure 7 The layers are stacked relative to each other in a potting mold. Before heat-sealing the layers, the hollow fiber pad material must be correctly positioned by making the multiple lines 92 parallel to the X-axis and the hollow fibers 94 tilted at an angle α or β relative to the Y direction (orthogonal to X). Furthermore, the heat-sealing grooves 98 must be diametrically opposed to each other and oriented parallel to the X-axis. Heat sealing is necessary to obtain the layers because it maintains the relative positioning (i.e., creates the tilt angle) between the multiple hollow fibers 94 and the multiple lines 92, and marks the correct positions of the two grooves by fixing them in place, making the subsequent stacking process possible in which all hollow fiber pad layers 90 are aligned with the multiple lines 92 parallel to the first direction, and the multiple hollow fibers 94 in adjacent layers are alternately tilted relative to a direction perpendicular to the first direction. In summary, the stacking process can be completed without any rotation of the multiple hollow fiber pads 90, because the inclination between the hollow fibers 94 in the different hollow fiber pads 90 provides sufficient cross-orientation between the hollow fibers, the grooves being given by the specific formation process of each layer 90 described above. This is key in increasing the ease of assembly (which can be easily automated) of the oxygenator device 20 while improving heat transfer and gas exchange efficiency and reducing the possibility of inconsistencies during manufacturing.

[0063] So far, in this embodiment, the oxygenator module 22 is shown stacked close to the heat exchanger module 24, with neither module rotating relative to the other. Various other embodiments are also possible, such as where the oxygenator module 22 and heat exchanger module 24 are stacked adjacent to each other, or rotated by an angle about the Z-axis. This angle can be zero (e.g., ...). Figures 2 to 6 The value is between 90 degrees (as shown in the diagram). In such embodiments, the potting compound 80 may also be molded in two steps to accommodate the tilted positioning of the heat exchanger module 24 and the oxygenator module 22, instead of being stacked parallel to each other. Furthermore, the orientations of the H / C fluid inlet chamber 66 and the H / C fluid outlet chamber 70, as well as the gas inlet chamber 68 and the gas outlet chamber 72, will be rotated accordingly to maintain communication with the corresponding halves of the hollow fiber terminals within the oxygenator module 22 and the heat exchanger module 24. Additionally, other embodiments are possible where the heat exchanger module 24 is absent and the device 20 includes only the oxygenator module 22.

[0064] Numerous features and advantages, including various alternatives and details of the structure and function of the apparatus and / or method, have been set forth in the foregoing description. Furthermore, the inventive scope of the various concepts set forth in this disclosure has been described generally and with respect to specific examples. This disclosure is intended to be illustrative only and is not intended to be exhaustive. For example, various embodiments of this disclosure are described in the context of medical applications, but they can also be used in non-medical applications. It will be apparent to those skilled in the art that various modifications can be made, particularly in terms of structure, materials, elements, components, shape, size, and arrangement of components (including combinations within the principles of the invention), to reflect the full scope and general meaning of the appended claims. Such various modifications are intended to be included in the appended claims, provided they do not depart from the spirit and scope of the appended claims.

Claims

1. An oxygenation device for use in conjunction with extracorporeal blood circulation, the device comprising: A cylindrical potting compound, the potting compound including a first alignment feature defining an alignment axis of a defined diameter; An oxygenator module comprising a stacked layer formed by stacking multiple single-layer circular hollow fiber pads for oxygen exchange, each of the multiple single-layer circular hollow fiber pads for oxygen exchange including a second alignment feature configured to align and coincide with a first alignment feature of the potting compound, such that each of the multiple hollow fiber pads is oriented relative to the alignment axis. A heat exchanger module, the heat exchanger module comprising a stacked layer formed by stacking multiple single-layer circular hollow fiber pads for heat exchange; The cylindrical potting body is a single unit, and is filled with hollow fiber pads for the oxygenator module and the heat exchange module. The hollow fiber pads in the oxygenator module and the heat exchanger module each include multiple parallel lines coupled to multiple hollow fibers, the multiple lines being aligned with the alignment axis at an angle not orthogonal to the arrangement of the multiple hollow fibers. A blood inlet, said blood inlet being located near the first end of the filling body; A blood outlet is located near the second end of the potting body opposite the first end; A gas inlet and a gas outlet, the gas inlet and the gas outlet being used to guide a gas mixture through multiple hollow fibers of multiple hollow fiber pads in the oxygenator module; and A fluid inlet and a fluid outlet, the fluid inlet and the fluid outlet being used for H / C fluid to enter and exit a portion of the potting compound; The stacking order of each hollow fiber pad in the oxygenator module and the heat exchanger module alternates as follows: the first hollow fiber pad in the plurality of hollow fiber pads is provided with a first plurality of parallel hollow fibers, the first plurality of parallel hollow fibers being arranged at a first angle relative to a direction orthogonal to the alignment axis; the second hollow fiber pad in the plurality of hollow fiber pads is provided with a second plurality of parallel hollow fibers, the second plurality of parallel hollow fibers being arranged at a second angle relative to a direction orthogonal to the alignment axis; the first angle and the second angle are arranged on opposite sides of the direction orthogonal to the alignment axis; wherein, the first angle and the second angle are different, and each of the first angle and the second angle is between 0 degrees and 25 degrees, and is not 0 degrees.

2. The device of claim 1, wherein the fluid inlet and the fluid outlet are configured to guide the H / C fluid through at least two of the hollow fiber pads of the heat exchanger module.

3. The device of claim 1, wherein the potting body further includes a distribution grid between the blood inlet and the heat exchanger module.

4. The device according to claim 1, wherein the potting compound further includes a separation grid between the heat exchanger module and the oxygenator module.

5. The device of claim 1, wherein the filling body further comprises a collection grid between the oxygenator module and the blood outlet.

6. The device according to claim 1, wherein the filling body comprises a circular distribution grid between the blood inlet and the heat exchanger module, a circular separation grid between the heat exchanger module and the oxygenator module, and a circular collection grid between the oxygenator module and the blood outlet.

7. The device of claim 1, further comprising a first housing adjacent to the first end of the potting compound and a second housing adjacent to the second end of the potting compound.

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