Organic fluid oxygenator

Abstract

The present invention provides an organic fluid oxygenator (10) comprising a container body (20); a first hole (21) for oxygen entry and a second hole (22) for exhaust gas exit; a third hole (23) for entry of organic fluid to be oxygenated and a fourth hole (24) for exit of oxygenated organic fluid; an oxygenation chamber (30) for oxygenating the organic fluid to be oxygenated, defined within the container body (20); and a mass (31) of capillary fibers (32) impermeable to liquids but permeable to gases, arranged parallel to each other in a first direction (X) to be wrapped by the organic fluid within the oxygenation chamber (30).

Description

Technical Field

[0001] This invention relates to an organic fluid oxygenator, particularly for oxygenating blood flowing in an extracorporeal circulation loop. Background Technology

[0002] Oxygenation devices (hereinafter referred to as oxygenators) have been known for some time for oxygenating organic fluids, particularly blood flowing in a cardiopulmonary bypass circuit. Oxygenators are installed on the cardiopulmonary bypass circuit and connected to a patient receiving cardiopulmonary support therapy, etc. An example of an oxygenator of a known type in the art is described in WO 00 / 06357.

[0003] Typically, an oxygenator consists of a container, which may be cylindrical or parallelepiped in shape, and its interior defines a gas exchange chamber or oxygenation chamber containing clumps of hollow fibers.

[0004] Hollow fibers are, in practice, capillary segments, and depending on the standard configuration, have open cavities at their opposite ends. The fibers are made of a gas-permeable but liquid-impermeable material, allowing only gas to pass through the fiber's interior. Under these specific conditions, only oxygen can coat the outer surface of the fiber in a direction orthogonal to its longitudinal axis during blood flow.

[0005] All ends of the fiber clumps are open and open to the corresponding chambers to accumulate oxygen to be transported and carbon dioxide released from the blood during the gas exchange process.

[0006] Oxygen flows within each fiber and is released into the bloodstream during gas exchange to perform oxygenation. Simultaneously, the blood releases carbon dioxide that permeates through the membrane thickness of the hollow fibers, thus drawing waste gas into the collection chamber, from which it is then discharged outside.

[0007] The container forming the body of the oxygenator includes at least two holes for oxygen to enter and for carbon dioxide released during gas exchange to exit, and at least two other holes for blood to be treated to enter and for blood to be treated to exit.

[0008] The hollow fiber clumps are then retained at both ends by what is called “encapsulation”, whereby an integral element made of polyurethane-based material binds its ends together, thus blocking it in a fixed position within the oxygenation chamber.

[0009] Hollow fiber clumps are typically made in bundles, which are rolled onto a core or on themselves in a direction transverse to the fibers to form a generally cylindrical and elastically deformable body to accommodate the size and shape of the oxygenation chamber defined by a cylindrical container via interference fit on the rolled bundle. Other known solutions provide folding hollow fiber sheets onto a sheet, such as a corrugated tube method in which the hollow fibers are interconnected by threads typically on the micrometer scale, where the threads determine whether they are warp or weft. In any case, once installed, the hollow fibers will always be in contact with each other.

[0010] Because hollow fibers are very expensive and require delicate handling, their installation is a critical aspect of oxygenators. During fiber installation, there are inherent risks: if the fibers are compressed too tightly, they can be crushed, causing one or more fibers to close; this can also impair the uniformity of the hydraulic flow through which blood passes, reducing the useful contact area with blood due to excessive surface contact between capillaries or layers; or, more seriously, the fibers may break and rupture, causing blood leakage within the capillary lumen.

[0011] Document WO2018173092A1 discloses an oxygenator in which a hollow fiber mass consists of a set of hollow fiber sheets arranged in parallel and folded in a corrugated manner, and is equipped with one or more spacers located between two consecutive layers to form a space between them designed to allow blood to flow out correctly. The spacers have planar elements with a central aperture defining a hydraulic section that facilitates blood flow. The oxygenator, corresponding to a pretreatment chamber into which blood enters, also includes a dynamic dispensing device and two perforated diaphragms that accommodate the hollow fiber mass located upstream and downstream of it relative to the direction of blood flow, thereby also performing the function of dispensing blood flow.

[0012] This solution cannot fully meet the requirements of this part because the insertion of spacers makes the assembly of hollow fiber clusters more complex and slower. Furthermore, according to the ideal hydraulic model, the fiber setup cannot be fully controlled and faithfully reproduced, potentially leading to irregular fiber networks and uneven blood flow.

[0013] Another disadvantage of using spacers is that the overall size of the oxygenator cannot be reduced, especially the internal volume of the oxygenation chamber. In fact, the volume occupied by the spacers themselves cannot be reduced.

[0014] Therefore, it is necessary to improve an oxygenator that can overcome at least one of the shortcomings of the existing technology.

[0015] In particular, one object of the present invention is to provide an oxygenator that makes the assembly of hollow fiber clumps easier, faster, and more controllable, while ensuring their integrity.

[0016] Another object of the present invention is to provide an oxygenator that can reduce the risk of allergic reactions that may occur when blood comes into contact with external surfaces.

[0017] Another objective is to provide an oxygenator whose size and therefore the volume that must be filled are smaller than those of known oxygenators.

[0018] Another objective is to provide an oxygenator that, compared to known oxygenators, minimizes the total exchange surface area of ​​the capillaries in contact with blood, given the same performance requirements.

[0019] Another objective is to refine a method for manufacturing clumps of capillary fibers that is easier, faster, and more controllable than known methods.

[0020] The applicant has designed, tested and implemented the present invention to overcome the shortcomings of the prior art and to obtain these and other objectives and advantages. Summary of the Invention

[0021] The independent claims set forth and describe the invention. The dependent claims describe other features or variations of the main inventive concept of the invention.

[0022] In accordance with the above objectives, an organic fluid oxygenator is described below, which overcomes the limitations of the prior art and eliminates the defects present therein.

[0023] According to some embodiments, an organic fluid oxygenator is provided, comprising a container body that internally defines an oxygenation chamber. The container body includes a first port for gas inlet and a second port for exhaust gas outlet. Advantageously, the gas is oxygen, and the exhaust gas also contains carbon dioxide.

[0024] The container body also includes a third port for the inlet of the organic fluid and a fourth port for the outlet of the organic fluid. Advantageously, the organic fluid is blood. The third and fourth ports are preferably located upstream and downstream of the oxygenation chamber, respectively, relative to the outlet of the organic fluid.

[0025] The oxygenator also includes multiple capillary fibers or clumps of capillary fibers contained within the oxygenation chamber. The capillary fibers are made of a gas-permeable but liquid-impermeable material, thus allowing only gas to exchange with the organic fluid being treated. The capillary fibers are oriented parallel to each other along a first direction and configured such that their exterior is enveloped by the organic fluid.

[0026] The clump of capillary fibers comprises at least two capillary fiber sheets in contact with each other along their respective surfaces. In each sheet, the capillary fibers are connected and equidistant from each other by at least two connecting lines oriented along a second direction. The second direction is orthogonal or oblique to the first direction in which the capillary fibers are oriented. Advantageously, the connecting lines are wound or entangled around each individual capillary fiber. The two sheets are offset from each other along the first direction.

[0027] Preferably, each fiber sheet is a single-layer sheet, that is, it consists of a single layer of capillary fibers.

[0028] Preferably, the two sheets are also offset along the second direction. In this way, the capillary fibers of each sheet are not in the same position as the capillary fibers of the other sheet, thereby making the distance between the two sheets more uniform.

[0029] According to some embodiments, the oxygenator includes a chamber for the inflow of organic fluid, the chamber being disposed between a third inlet port for the organic fluid and the oxygenation chamber. Preferably, the inlet chamber includes a static distribution device configured to uniformly distribute the flow of organic fluid.

[0030] In a preferred embodiment, the oxygenator further includes a chamber for discharging organic fluid, located between the oxygenation chamber and a fourth discharge port for the organic fluid. More preferably, the discharge chamber includes a second static distribution device configured to uniformly distribute blood flow and direct it to the fourth discharge port for the organic fluid.

[0031] According to one aspect, a method for forming a clump of capillary fibers in the oxygenation chamber of an oxygenator to be inserted is also provided. The method provides at least two capillary fiber sheets, each sheet comprising a plurality of capillary fibers arranged parallel to each other along a first direction, and at least two connecting lines for connecting the capillary fibers, the connecting lines being oriented in a second direction perpendicular or inclined to the first direction. The at least two sheets are then brought into contact with each other with their respective surfaces facing each other and offset along the first direction such that the lines of one sheet are offset relative to the lines of the other sheet. In this way, externally woven threads are formed on the various capillary fibers to contact the capillary fibers of the other sheet.

[0032] According to some embodiments, these sheets are supplied by corresponding rolls. Such rolls are preferably offset along a first direction.

[0033] According to some embodiments, the method provides a way of arranging the sheets such that contact between the sheets occurs only between the lines of one sheet and the capillaries of the other sheet. Attached Figure Description

[0034] These and other aspects, features, and advantages of embodiments of the present invention will become apparent from the non-limiting examples in the accompanying drawings, wherein:

[0035] - Figure 1 This is a perspective view of an organic fluid oxygenator according to an embodiment described herein;

[0036] - Figure 2 yes Figure 1 A cross-sectional view of the oxygenator shown.

[0037] - Figure 3 yes Figure 1 Bottom perspective view of the oxygenator component shown;

[0038] - Figure 4A and Figure 4B They are Figure 1 Perspective view and plan view of the second component of the oxygenator shown;

[0039] - Figure 5A This is a schematic diagram of two rolls of capillary sheets used in the detailed steps of manufacturing the oxygenator;

[0040] - Figure 5B yes Figure 5A A magnified view of detail A;

[0041] - Figure 5C yes Figure 5B Two side views of a portion of a capillary sheet;

[0042] - Figure 6 It is a cross-sectional view of an oxygenator based on a variant; and

[0043] - Figure 7 Is making Figure 6 A perspective view of the steps of the oxygenator shown.

[0044] For ease of understanding, identical reference numerals are used to identify identical common elements in the figures where possible. It will be understood that elements and features of one embodiment can be readily combined or incorporated into other embodiments without further clarification. Detailed Implementation

[0045] Reference will now be made in detail to possible embodiments of the invention, one or more of which are illustrated by way of non-limiting example in the accompanying drawings. The phrases and terms used herein are also intended to provide non-limiting examples.

[0046] Figure 1 An organic fluid oxygenator is shown, generally indicated by the numeral 10. The oxygenator 10 includes a container body 20, within which an oxygenation chamber 30 is defined. Figure 2 ).

[0047] Advantageously, the container body 20 defines a longitudinal axis A and is preferably in the shape of a parallelepiped, that is, the container body 20 includes an upper wall 20A and a lower wall 20B, wherein the upper wall 20A and the lower wall 20B are opposite to and perpendicular to the longitudinal axis A; and four side walls 20C, wherein the four side walls 20C are connected to the upper wall 20A and the lower wall 20B, and preferably extend along their respective axes parallel to the longitudinal axis A.

[0048] The container body 20 includes a first port 21 for gas inlet and a second port 22 for the same gas to exit in the exhaust state. In the specific case of the oxygenator, the gas is oxygen, while the exhaust gas may include oxygen and contain carbon dioxide.

[0049] In the illustrated example, the first hole 21 and the second hole 22 correspond to two opposite sidewalls 20C, allowing gas flow to pass from one side of the oxygenation chamber 30 to the other. Figure 2 However, other locations for the first orifice 21 and the second orifice 22 may also be provided, provided that they can determine the path of the gas passing through the oxygenation chamber 30 at least once.

[0050] The container body 20 also includes a third hole 23 for the entry of organic fluid and a fourth hole 24 for the discharge of organic fluid. Figure 2 and Figure 3 In this case, the organic fluid to be processed (i.e., to be oxygenated) is blood, but the oxygenator is compatible with other types of organic fluids.

[0051] It should be noted that each of holes 21, 22, 23, and 24 is provided with a corresponding connecting pipe 21A, 22A, 23A, or 24A for connection to the corresponding system supplying gas or organic fluid. Figure 1 , Figure 2 and Figure 3 ).

[0052] In one advantageous manner, a connecting pipe 24A providing a fourth hole 24 may have one or more connecting elements 24B, 24C. Figure 1 , Figure 2 and Figure 4A The connecting elements 24B and 24C are configured to connect instruments or accessories (e.g., devices for measuring organic fluid parameters).

[0053] Preferably, the third hole 23 and the fourth hole 24 are located upstream and downstream of the oxygenation chamber 30, respectively, relative to the direction of organic fluid outflow, and are parallel or longitudinal to the longitudinal axis A.

[0054] Specifically, in a preferred embodiment, the third hole 23 is located in the upper wall 20A of the container body 20, and the fourth hole 24 is located in the lower wall 20B. Figure 1 and Figure 2In this way, the organic fluid flows from top to bottom through the oxygenation chamber 30.

[0055] As can be seen, the fourth hole 24 is preferably located at the center relative to the lower wall 20B, that is, at the center relative to the vertical axis A. Figure 2 , Figure 4A and Figure 4B Conversely, the third hole 23 is preferably spaced from the longitudinal axis A and is located on the upper wall 20A in any case, more preferably on the dome 40A. Figure 3 ).

[0056] The third opening 23 leads to the container body 20 and advantageously to the entry chamber 40 located between the third opening 23 and the oxygenation chamber 30. In the example shown, the entry chamber 40 is formed in the upper wall 20A of the container body 20, thereby forming a dome 40A extending outward from the container body 20. Preferably, the dome is coaxial with respect to the container body 20, i.e., their longitudinal axes coincide.

[0057] Advantageously, the entry chamber 40 is provided with a static dispensing device 41. According to some embodiments, the dispensing device 41 is integrally formed in the upper wall 20A of the container body 20 and protrudes from its inner surface. Figure 3 The dispensing device 41 may be fin-shaped, preferably curved, with its concave surface facing the interior of the dome 40A.

[0058] More advantageously, the fins 41 are configured to have a flat lower surface 42, so that the flat lower surfaces 42 of all the fins 41 are disposed on the same plane, which defines the inlet chamber 40 of the organic fluid at the bottom. Figure 2 Preferably, the lower surface 42 of the fin 41 is perpendicular to the longitudinal axis A.

[0059] The dome 40A allows for the accumulation of air that may be present in the organic fluid, preventing air buildup in the oxygenation chamber 30 and preventing potential embolisms in the case of blood as the organic fluid. For air venting purposes, an upper opening 43, preferably a tubular upper opening, may be provided at the top of the dome 40A extending toward the exterior of the container body 20, and may be provided with a connecting device 44 for connecting it to an external system. Figure 1 and Figure 2 ).

[0060] Similarly, the lower wall 20B preferably defines an organic fluid discharge chamber 50 located between the oxygenation chamber 30 and the fourth hole 24. Figure 2 The discharge chamber 50 is suitably provided with its own static distribution device 51, which is configured as fins protruding from the inner surface of the lower wall 20B. Advantageously, the fins 51 are integrally formed in the lower wall 20B.

[0061] Advantageously, fin 51 is vertical and radially oriented relative to the fourth hole 24 (i.e., relative to the longitudinal axis A). Figure 4B In this way, the outflow of organic fluid at the outlet of oxygenator 10 is improved. The fins 51 can have different lengths depending on their position, particularly their distance from the fourth hole 24.

[0062] The fin 51 has a flat upper surface 52, preferably perpendicular to the longitudinal axis A. Preferably, the fin 51 is configured such that its upper surface 52 lies in the same plane, advantageously perpendicular to the longitudinal axis A that defines the discharge chamber 50 at the top.

[0063] It can be inferred that the oxygenation chamber 30 is contained between the lower surface 42 of the fin 41 of the upper wall 20A and the upper surface 52 of the fin 52 of the lower wall 20B. Figure 2 The surfaces 42 and 52 of the fins 41 and 51 are joined together to form upper and lower stationary planes for the insertion of the capillary fiber 32 clumps 31 into the oxygenation chamber. This eliminates the need for the perforated distribution plate present in the prior art.

[0064] It should be noted that the lower surface 20B may be defined to have the same shape and size as the dome 40A. Figure 3 and Figure 4B The dome 40A and the internal region 50A define a useful hydraulic section through which organic fluid flows through the oxygenation chamber 30. The dome 40A and the internal region 50A define an inlet chamber 40 and an outlet chamber 50 for the organic fluid, respectively, at their peripheries.

[0065] Within the oxygenation chamber 30, a cluster 31 of capillary fibers 32 made of a gas-permeable but liquid-impermeable material is disposed. All capillary fibers 32 are oriented in the same first direction X, preferably perpendicular to the longitudinal axis A. Figure 2 Both ends of the capillary fiber 32 are open, allowing gas to enter and exit from its interior. Therefore, the open ends of the fiber can be isolated from the oxygenation chamber 30 to prevent organic fluids from clogging them.

[0066] For this purpose, the oxygenator 10 may include a support 25 to support the capillary fibers 32, the support only engaging the two ends of the capillary fibers. Figure 2 The support member 25 is referred to as "potting". Advantageously, the "potting" is configured so as not to interfere with or only slightly interfere with the useful hydraulic parts of the oxygenator 10.

[0067] The capillary fibers 32 are configured to provide fluid communication between the first side chamber 60 and the second side chamber 70. The first side chamber 60 is located on the side opposite to the oxygenation chamber 30, while the second side chamber 70 is also located on the side opposite to the oxygenation chamber 30, but on the opposite side of the first side chamber 60.

[0068] Advantageously, the first side chamber 60 is defined externally by the side wall 20C where the first hole 21 is located, while the second side chamber 70 is defined externally by the side wall 20C where the second hole 22 is located. Figure 2 In other words, the first side chamber 60 is located between the first orifice 21 and the oxygenation chamber 30, and the second side chamber 70 is located between the second orifice 22 and the oxygenation chamber 30.

[0069] The side chambers 60 and 70 can be configured as two halves that can be sealed together and combined to form the container body 20. For example, the halves can be generally semi-annular to limit the hydraulic components when they are joined together.

[0070] The clumps of fiber 31 are obtained using two sheets 33A and 33B of capillary fibers 32. Each sheet 33A and 33B consists of multiple capillary fibers 32 arranged parallel to each other along a first direction X, and interconnected by at least two lines 34A and 34B wound on the outer surface of the capillary fibers 32 and oriented in a second direction Y at an angle relative to the first direction X (preferably perpendicular to the first direction X). Figure 5B and Figure 5C The second direction Y is also perpendicular to the longitudinal axis A. Lines 34A and 34B also help maintain the equidistant spacing between capillary fibers 32.

[0071] It should be noted that the capillary fibers 32 are preferably formed in a single layer in each sheet 33A, 33B. The diameter of the capillary fibers 32 can be on the order of several hundred micrometers, for example, 380 μm, while the thickness of the fibers 34A, 34B can be on the order of 10 μm.

[0072] Each sheet 33A, 33B preferably includes multiple lines 34A, 34B regularly distributed along the length of the capillary fiber 32 at a predetermined spacing P1. The spacing P1 can be on the order of several millimeters, for example, 10 mm.

[0073] Two sheets 33A and 33B are in contact with each other along the corresponding surfaces defined by capillary fiber 32. Figure 5B In principle, the capillary fibers 32 never come into contact with each other, because contact only occurs between the lines 34A, 34B of one sheet 33A, 33B and the capillary fibers 32 of the other sheet 33A, 33B, with the lines protruding from the outer surface of the capillary due to their thickness. In this way, they form a sheet with a double layer of capillary fibers 32. The sheets 33A, 33B are configured such that the lines 34A of the first sheet 33A are offset relative to the lines 34B of the second sheet 33B along a first direction X. Obviously, the offset value is preferably not equal to the spacing P between the lines 34A, 34B of the same sheet.

[0074] Therefore, the contact between the two sheets 33A and 33B actually occurs only between the threads 34A and 34B of one sheet and the fibers 32 of the other sheet. Furthermore, there is no predetermined spacing (e.g., 10 mm) between the threads 34A and 34B between the capillary fibers 32 of the two sheets; instead, the threads 34A and 34B alternate, with a smaller spacing, for example, less than 10 mm. This alternation of threads 34A and 34B forms a layer of threads interspersed between the capillary fibers 32 of the two sheets 33A and 33B.

[0075] By doing so, installing capillary fibers 32 in the oxygenation chamber 30 is easier, faster, and more controllable than with existing techniques. The capillary fibers 32 are spaced regularly apart, forming a uniform and repeatable three-dimensional matrix. This three-dimensional matrix defines hydraulic sections that facilitate the passage of organic fluid while preventing the capillary fibers 32 from contacting each other. Furthermore, it releases the contact surface of the organic fluid. With the same number of capillary fibers 32, the contact surface is higher, thus reducing the useful contact area between the fibers and the organic fluid. In the case of blood, this is an advantage because it reduces the risk of allergic reactions between blood and fibrous materials.

[0076] All of these also reduce the size of the oxygenator 10, especially its internal volume.

[0077] One method to achieve the offset of lines 34A and 34B is to simply offset two sheets 33A and 33B along a first direction X. For example, two rolls 330A and 330B that provide sheets 33A and 33B of capillary fibers 32 can be offset from each other along the first direction X so that the already offset sheets can be supplied. Figure 5A ).

[0078] The offset between lines 34A and 34B of the two sheets 33A and 33B is advantageously smaller than the spacing P1 between lines 34A and 34B of the same sheet 33A and 33B, thus making the distance between the lines smaller than the spacing P1. Advantageously, lines 34A and 34B are offset by half a spacing P1, so that they are regularly spaced at a distance equal to half a spacing P. When the spacing P1 is 10mm, the distance between lines 34A and 34B in a double-layered sheet is 5mm. Figure 5C ).

[0079] According to some embodiments, sheets 33A and 33B are also offset relative to each other along the second direction Y.

[0080] In each sheet 33A, 33B, capillary fibers 32 are appropriately spaced along the second direction Y at a second distance P2. Particularly advantageously, sheets 33A, 33B are offset by half of the second distance P2, such that the capillary fibers 32 of the first sheet 33A are located between two capillary fibers 32 of the second sheet 33B. Figure 5C In this way, the capillary fibers 32 form a more compact and stable three-dimensional network.

[0081] exist Figure 2 In the embodiment shown, the clump 31 of capillary fiber 32 is composed of two sheets 33A and 33B as described above, and is folded in a corrugated manner to fill the oxygenation chamber 30.

[0082] Figure 6 Another embodiment of the arrangement of capillary fibers 32 in subgroups 310 is shown. Each subgroup 310 includes a support 311, around which two sheets 33A, 33B of capillary fibers 32, configured as described above, are wound around several loops. Figure 7 ).

[0083] Advantageously, the support 311 is generally annular in shape, and the shape and size of its inner hole are larger than the shape and size of the dome 40A, so as not to interfere with the useful hydraulic parts of the oxygenator 10.

[0084] The following describes the assembly mode and operation mode of the oxygenator.

[0085] First, a removable or openable container body 20 is provided to make the oxygenation chamber inside available.

[0086] Subsequently, the agglomerates 31 of capillary fibers 32 are prepared by providing two sheets 33A and 33B, which are placed in contact with each other corresponding to their surfaces, and are configured such that the line 34A of the first sheet 33A is offset relative to the line 34B of the second sheet 33B. Figure 5B For example, two sheets 33A and 33B can be provided, preferably smaller than the distance P between lines 34A and 34B of the same sheet 33A and 33B, offset from each other along the first direction X.

[0087] Preferably, the two sheets 33A and 33B are fed in by their respective offset reels 330A and 330B, so that the sheets 33A and 33B are already offset when they are provided.

[0088] Advantageously, the two sheets 33A and 33B are also offset along the second direction Y, so that each capillary fiber 32 of one sheet 33A is positioned on a corresponding line resting between two capillary fibers 32 of the other sheet 33B. Figure 5C Therefore, the capillary fibers 32 of the two sheets 33A and 33B are symbolically spaced 10 μm apart from each other.

[0089] The two sheets 33A and 33B placed together (forming a single sheet with double-layered capillary fibers 32 in this way) are then shaped to be inserted into the oxygenation chamber 30 for filling. According to one embodiment, the sheets 33A and 33B are folded in a corrugated form to obtain different double-layered capillary fibers 32 stacked on top of each other. The resulting clump 31 is then inserted into the oxygenation chamber 30.

[0090] Alternatively, the sub-assembly 310 can be prepared by fabricating a support element 311 on a pair of sheets 33A and 33B, and repeatedly winding the sheets around the support element 311 until a sub-assembly 310 with a predetermined thickness is obtained. The thickness can be any thickness depending on the requirements or size of the oxygenation chamber 30 to be filled, or the number of sub-assemblies 310 to be used.

[0091] Then, as Figure 6 As shown, subgroup 310 is stacked in oxygenation chamber 30.

[0092] Once the clump 31 of capillary fibers 32 is installed, the container body 20 is sealed.

[0093] Subsequently, the oxygenator is connected to a suitable circuit, such as an extracorporeal circulation circuit for blood circulation or another organic fluid circulation, via connecting pipes 21A, 22A, 23A, 24A, and possibly also via upper hole 43 (if present).

[0094] The function of oxygenator 10 is similar to that of known oxygenators 10.

[0095] Obviously, modifications and / or additions to the oxygenator and the foregoing method may be made without departing from the scope and range of the invention as defined in the claims.

[0096] In the following claims, the markings in parentheses are for ease of reading only: they shall not be considered limiting factors with respect to the field of protection claimed in the particular claim.

Claims

1. An organic fluid oxygenator (10), the organic fluid oxygenator (10) comprising: - Container body (20); - A first hole (21) for oxygen to enter and a second hole (22) for exhaust gas to exit, both the first hole (21) and the second hole (22) are formed in the container body (20); - A third hole (23) for the oxygenated organic fluid to enter and a fourth hole (24) for the oxygenated organic fluid to exit, both the third hole (23) and the fourth hole (24) are formed in the container body (20); - An oxygenation chamber (30), said oxygenation chamber (30) for oxygenating the organic fluid to be oxygenated, and is confined within the container body (20); and - A mass (31) of capillary fibers (32) that are impermeable to liquids but permeable to gases, the mass of capillary fibers being arranged to be parallel to each other in a first direction (X) so as to be enveloped by the organic fluid within the oxygenation chamber (30). The clump (31) of the capillary fibers (32) comprises at least two sheets (33A, 33B) of capillary fibers (32), the at least two sheets of capillary fibers being interconnected by at least two connecting lines (34A, 34B) extending along a second direction (Y) perpendicular to the first direction (X), the sheets (33A, 33B) being in contact with each other along their respective surfaces, and the oxygenator (10) being characterized in that the sheets (33A, 33B) are configured such that the line (34A) of the first sheet (33A) is offset relative to the line (34B) of the other sheet (33B) along the first direction (X).

2. The oxygenator (10) according to claim 1, characterized in that, The two sheets (33A, 33B) are offset relative to each other along the first direction (X).

3. The oxygenator (10) according to claim 1 or 2, characterized in that, The two sheets of capillary fibers (32) (33A, 33B) are also offset along the second direction (Y).

4. The oxygenator (10) according to claim 1, characterized in that, The contact between the two sheets (33A, 33B) occurs only between the lines (34A, 34B) of each sheet (33A, 33B) and the capillary fibers (32) of the other sheet (33A, 33B).

5. The oxygenator (10) according to claim 1, characterized in that, The connecting lines (34A, 34B) of the same sheet (33A, 33B) are separated by a predetermined first spacing (P1), and the distance by which the two sheets (33A, 33B) are offset along the first direction (X) is equal to half of the first spacing (P1).

6. The oxygenator (10) according to claim 3, characterized in that, The capillary fibers (32) of the same sheet (33A, 33B) are separated by a second spacing (P2), and the distance by which the two sheets (33A, 33B) are offset along the second direction (Y) is equal to half of the second spacing (P2).

7. The oxygenator (10) according to claim 1, characterized in that, The oxygenator (10) includes an inlet chamber (40) for the organic fluid to be treated to enter, the inlet chamber (40) being located between the third hole (23) and the oxygenation chamber (30), and the inlet chamber (40) including a static dispensing device.

8. The oxygenator (10) according to claim 7, characterized in that, The static dispensing device includes fins (41) integrally formed with the upper surface (20A) of the container body (20).

9. The oxygenator (10) according to claim 8, characterized in that, The fins (41) have a flat lower surface (42), and the flat lower surface (42) of all the fins (41) is disposed on the same plane.

10. The oxygenator according to claim 1, characterized in that, The oxygenator includes a discharge chamber (50) for the organic fluid to be treated, the discharge chamber (50) being located between the oxygenation chamber (30) and the fourth hole (24), and the discharge chamber (50) including a second static dispensing device.

11. The oxygenator (10) according to claim 10, characterized in that, The second static dispensing device includes a second fin (51) of the second static dispensing device, which is integrally formed with the lower surface (20B) of the container body (20).

12. The oxygenator (10) according to claim 11, characterized in that, The second fin (51) has a flat upper surface (52), and the flat upper surface (52) of all the second fins (51) is disposed on the same plane.

13. A method of forming a mass (31) of capillary fibers (32) in an oxygenation chamber (30) to be inserted into an oxygenator (10), the method providing at least two sheets (33A, 33B) of capillary fibers (32), wherein each sheet comprises a plurality of capillary fibers (32) oriented parallel to a first direction (X), and at least two lines (34A, 34B) for connecting the capillary fibers (32), the two lines (34A, 34B) being oriented along a second direction (Y) perpendicular to the first direction (X) and contacting the sheets (33A, 33B) with each other along their respective surfaces, wherein the sheets (33A, 33B) are configured such that the line (34A) of the first sheet (33A) is offset relative to the line (34B) of the other sheet (33B) along the first direction (X).

14. The method according to claim 13, characterized in that, The sheets (33A, 33B) are provided by corresponding rolls (330A, 330B) offset along the first direction (X).

15. The method according to claim 13 or 14, characterized in that, The sheets (33A, 33B) are configured such that contact between them occurs only between the lines (34A, 34B) of each sheet (33A, 33B) and the capillary fibers (32) of the other sheet (33A, 33B).

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