FR3072293A1 - EXTRACORPORAL OXYGENATOR WITH INTEGRATED AIR CLEANING SYSTEM - Google Patents

Abstract

Extracorporeal blood circulation circuit devices can be used during medical procedures, including open-heart surgery with a pump. For example, extracorporeal heat exchange and oxygenation devices can be used to facilitate surgical procedures such as coronary artery bypass grafting. In some embodiments, such an oxygenator may include an integrated air removal structure. In particular embodiments, the air elimination structure may comprise one or more porous hollow fibers.

Description

EXTRACORPOREAL OXYGENATOR WITH INTEGRATED SYSTEM

AIR ELIMINATION

REFERENCE TO RELATED REQUESTS

The present application claims the benefit of the provisional American application serial number 62/572 754 filed on October 16, 2017. The description of the previous application is considered to be part of the description of the present application (and is incorporated by reference therein) ).

BACKGROUND

L Technical area

This document relates to devices used during surgical procedures for the treatment of cardiac pathologies. For example, this document relates to extracorporeal heat exchange and oxygenation devices which can be used for open heart surgery with a pump to facilitate surgical procedures such as a coronary artery bypass graft. Some extracorporeal heat exchange and oxygenation devices described in this document include an integrated air removal structure.

2. Background information

Hollow fiber oxygenators are used in the extracorporeal circuit to meet the gas exchange needs of a patient during a cardiopulmonary bypass operation. Blood from the patient is drained by gravity or active venous drainage assistance (VAVD) is. used to obtain the amount of circulation required to maintain sufficient volume in a tank. A pump (eg a peristaltic pump or a centrifugal pump coupled to a magnetic drive system) is used in the main line of the circuit in order to pump the blood present in the reservoir, through the oxygenator and finally towards the patient.

Before bridging begins, a priming solution based on crystalloids is pumped into the extracorporeal circuit to move the air present inside the components of the circuit. In some cases, some of the air inside the oxygenator may be difficult to remove during the priming process.

ABSTRACT

This document describes devices used during surgical procedures for the treatment of cardiac pathologies. For example, this ioci irnent describes devices for heat exchange and extracorporeal oxygenation> which can be used for an open heart operation, with a pump in order to fs oilitor of surgical interventions such as a transplant for bypass surgery. The extracorporeal heat and oxygen exchange described herein may include an integrated air removal structure.

In one aspect, the invention relates to a blood oxygenator that includes a blood inlet and a blood outlet. A path of blood circulation extends from the admission of blood to the discharge of blood, the blood oxygenating apparatus also comprises a part of gas exchange spoiée along the path of blood circulation; a spo heat exchange part along the blood circulation path before the gas exchange part: and one or more porous hollow fibers disposed along the circulation path before the heat exchange part.

Such a blood oxygenator may optionally include one or more of the following features. An interior portion of the porous hollow fiber (s) can communicate with an ambient space in or around the blood oxygenator. An interior portion of the porous fibber (s) may communicate with a source of vacuum. The oxygenator of - / year: may also include a circulation distribution element disposed along the blood circulation path before the porous hollow fiber or fibers. In some embodiments, the porous hollow fiber (s) are wrapped around the circulation distribution element. The porous hollow fiber or fibers can be wrapped around the circulation distribution element in a criss-cross helical pattern. The porous hollow fiber (s) may be arranged as a support for the circulation distribution element in a non-crossed pattern. The pores; porous hollow fiber (s) can allow air to enter the porous hollow fiber (s) while preventing liquid from entering the porous hollow fiber (s).

In another aspect, the invention relates to a blood oxygenating apparatus which comprises: (i) a housing defining an inlet port for s mg and a port for discharging blood; (ii) a heat exchanger arranged in the housing, the heat exchanger defining an internal space; (iii) a membrane oxygenator part disposed in the housing, the oxygenator part being arranged concentrically around the heat exchanger; and (iv) one or more porous hollow fibers disposed in the internal space.

Such a blood oxygenator may optionally include one or more of the following features. The blood oxygenator may also include a circulation distribution element disposed in the internal space. The porous hollow fiber (s) can be wrapped around the circulation distribution element. The circulation distribution element can be configured to facilitate a substantially uniform radial circulation distribution of the blood entering the heat exchanger. An inner part of the porous hollow fiber (s) can communicate with an ambient space in or around the blood oxygenator. An interior portion of the porous hollow fiber (s) can communicate with a vacuum source. The porous hollow fiber (s) can be arranged in a crisscross pattern. The porous hollow fiber or fibers can be arranged in a non-crossed pattern.

In another aspect, the invention relates to a method of configuring a blood oxygenator. The method includes: placing a membrane oxygenator in a housing which defines: (i) a blood inlet, (ii) a blood outlet and (iii) a blood circulation path extending from the blood inlet to evacuation of blood; have a heat exchanger along the blood circulation path before the membrane oxygenator; and have one or more porous hollow fibers along the blood flow path before the heat exchanger.

Such a method may possibly include one or more of the following characteristics. The porous hollow fiber (s) may be arranged such that an interior portion of the porous hollow fiber (s) communicates with an ambient space in or around the blood oxygenator. The method may also consist in configuring the oxygenating device to connect the. or porous hollow fibers to a vacuum source. The method may also include placing a circulation distribution element along the blood circulation path before the porous hollow fiber (s). The porous hollow fiber (s) can be wrapped around the circulation distribution element. The porous hollow fiber (s) can be wrapped around the circulation distribution element in a criss-cross helical pattern. At least some interwoven porous hollow fibers may be in fluid communication with each other as a contact between them. The porous hollow fiber or fibers may be arranged around the circulation distribution element in a non-crossed pattern. The pores of the porous hollow fiber (s) can allow air to enter the interior of the porous hollow fiber (s) while preventing liquid from entering the porous hollow fiber (s).

Particular embodiments of the object described in J; this document can be implemented in order to achieve one or more of the following ivæ itages. In some embodiments, using the devices and methods provided herein, patients may undergo an open heart operation which may have fewer adverse effects. For example, by using certain embodiments described herein, a patient will be less exposed to the possibility of receiving gas emboli from the extracorporeal circuit. Thus, the riscue of lack of oxygen (e.g. stroke and other types of tissue iemia) can be reduced. In addition, in some cases, the time not taken by clinicians to initiate the extracorporeal circuit to ensure that the air in the laughing wax is sufficiently removed can be reduced. Therefore, a less expensive clinical intervention is possible, and the risk of clinical error can be reduced. In addition, the use of certain embodiments described herein may allow the use of a simplified extracorporeal circuit in comparison with h s conventional extracorporeal circuits which use additional air elimination devices. In addition, the air removal structure described herein facilitates the use of an oxygenator device with a small priming volume. Such a device with a small priming volume can lead to a decrease in the dilution of the patient's blood compared to conventional extracorporeal circuits. As the hemodilu don is less, the possibility that the patient's hematocrit drops below a critical value is reduced, and the patient is therefore less likely to require blood use.

Unless defined otherwise, all of the technical and scientific terms used herein have the same meaning as that which is generally understood by 1 ’om om ordinary trade, in the field of which this invention. Although processes and materials similar or equivalent to those described herein may be used to carry out the invention, suitable processes and materials are (written here. All publications, patent applications, all patents and others References mentioned herein are incorporated by reference in their entirety.In case of dispute, this request, including definitions, will prevail.Moreover, materials, processes and examples are given for illustrative purposes only and are not intended to be limiting.

The details of one or more embodiments of the invention are indicated in the accompanying drawings and the description herein. Other features, objects and advantages of the invention will become apparent from the description and drawings, as well as from the claims.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a patient undergoing an open heart operation while being assisted by an extracorporeal circuit in accordance with certain embodiments provided here.

FIG. 2 is a schematic illustration of an extracorporeal oxygenator (and of an integrated heat exchanger), in accordance with certain embodiments provided for herein.

FIG. 3 schematically illustrates a priming process for the extracorporeal oxygenator of FIG. 2.

FIG. 4 is a schematic illustration of an extracorporeal oxygenator (and of an integrated heat exchanger) which comprises an integrated structure for removing air, in accordance with certain embodiments provided for herein.

FIG. 5 schematically illustrates a priming process for the extracorporeal oxygenator of FIG. 4.

FIG. 6 is an exploded view in section and in perspective of an extracorporeal oxygenator (and of an integrated heat exchanger).

FIG. 7 is an exploded view, in section and in perspective of an extracorporeal oxygenator (and of an integrated heat exchanger) which comprises an integrated structure for removing air, in accordance with certain embodiments provided for herein.

FIG. 8 is a photograph of a terminal portion of an extracorporeal oxygenator (and an integrated heat exchanger) which includes an integrated air removal structure, in accordance with certain embodiments provided herein.

The same reference numbers represent corresponding parts from start to finish.

DETAILED DESCRIPTION

This document describes devices used during int <rve: surgical links for the treatment of cardiac pathologies. For example, this document describes extracoq ·, oral s heat exchange and oxygenation devices which can be used for an open heart operation with a pump in order to perform surgery such as a coronary bypass graft Certain extracorporeal heat exchange and oxygenation devices described above may include an integrated air elimination structure.

Referring to FIG. 1, a patient 10 can receive medical treatment while using an extracorporeal blood circulation circuit 100 given as an example. In this illustrative example, the patient 10 is in the process of performing a cardiac bypass intervention using the circuit 100 of extracorporeal blood circulation. The circuit 100 is connected to the patient 10 at the level of the heart 12 »u p itient. The blood from patient 10 is drawn from patient 10 at the heart; 12 of the patient; blood is circulated in circuit 100; and the blood is then 2d ivoie to the heart 12 of the patient.

The circuit 100 for extracorporeal blood circulation given by way of example comprises, at least, a venous tube 110, a blood reservoir 120, a pump 130, an oxygenator 140, an arterial filter 150 and an arterial tube 160. The tube ve new .x 110 is in physical contact with the heart 12 and in fluid communication with the venous side of the patient's circulatory system 10. The venous tube 110 is also in fluid communication with an inlet to the reservoir 120. An evacuation coming from the reservoir 120 is connected by hose to an inlet of pump 130. The outlet of pump 130 is connected by hose to an inlet of oxygen generator 140. The outlet of oxygenator 140 is connected by hose to inlet 1 dt arterial filter 150. An evacuation of the arterial filter 150 (which is optional) is connected to the arterial tube 160. The arterial tube 160 is in physical contact with the heart · 12 and in fluid communication with the rib arterial circulatory system pat ent 0.

In short, the circuit 100 of extracorporeal blood circulation works by withdrawing the venous blood from the patient 10 via the venous tube IL 1. The blood coming from the venous tube 110 is deposited in the reservoir 120. At least a certain quantity of blood is intended to be maintained in the reservoir 120 permanently during the medical intervention. The blood from the reservoir 120 is drawn from the reservoir 120 by the pump 130. The pressure generated by the pump 130 propels the blood through the oxygenator 140. In the oxygenator 140, the venous blood is enriched with oxygen. In addition, in certain cases the temperature of the blood can be selectively increased or decreased using a heat exchanger which is integrated into the oxygenator 140. The arterial blood rich in oxygen leaves the oxygenator 140, moves at through the arterial filter 150, and is injected into the patient's heart 12 by the arterial tube 160,

Those skilled in the art will recognize that, before use, the extracorporeal blood circulation circuit 100 initially contains air which must be moved before the circuit 100 can be connected to the patient 10. To move the air in the circuit 100, a priming solution is introduced into circuit 100. This process is called priming of circuit 100.

Referring to FIG. 2, an example of an oxygenator comprising an integrated heat exchanger 200 (or simply "an oxygenator 200") is illustrated diagrammatically. The oxygenator 200 includes a housing 202. The housing 202 defines an inlet port 203i and an outlet port 203o. A blood circulation path extends from the inlet port 203i to the outlet port 203o.

A heat exchanger 206 is disposed along the blood circulation path. As the blood (or priming solution) enters the housing 202 through the inlet port 203i, the blood generally flows radially to the heat exchanger 206, and continues to flow radially into the heat exchanger 206. Thermoregulated water also passes through the heat exchanger 206, from an inlet orifice 207i to an outlet orifice 207o (or in the opposite direction). While the heat exchanger 206 allows heat to be transferred between the thermoregulated water and the blood, the wall (s) of the heat exchanger 206 physically separate the thermoregulated water from the blood (to prevent mixing) in the conventional manner d 'a heat exchanger. The heat exchanger 206 can be made of metallic or polymeric materials. In some embodiments, the heat exchanger 206 is fabricated with multiple small tubes. An internal space 204 is defined by the heat exchanger 206. The incoming blood flows through the internal space 204 before reaching the heat exchanger 206.

In some embodiments, a circulation distribution element 205 is disposed in the internal space 204. The circulation distribution element 205 is configured to facilitate a substantially uniform radial circulation distribution of blood as it enters the internal space 204 and places it in the heat exchanger 206.

A portion 208 of oxygenator (which may also be referred to as a "gas exchange portion") is disposed in the housing 202 along the blood circulation path after the heat exchanger 206. In some: embodiments, the part 208 of the oxygenator is arranged concentrically mtoar of the heat exchanger 206 so that the blood flowing radially around the heat exchanger 206 can continue to flow radially through the part 208 of the oxygenator. The gases also pass through part 208 of ox; manager, from an intake port 209i to an exhaust port 209o. The oxygenator part 208 can be made of hollow fibers (membranes) which allow a transfer of gases (eg, exchanges of oxygen and carbon dioxide in gases and blood while preventing mixing direct from gas and blood.

In certain embodiments, the ends of the individual tube elements of the heat exchanger 206 and / or of the oxygen iteir part 208 are physically bonded together using a coating material 210. The material d coating 210 may be urethane in some cases. After the coating material 210 has been applied (in a flowable state) to the ends of the individual tubular elements of the heat exchanger 206 and / or of the oxygenator part 208, the coating material 210 is solidify. In the solid state, the coating material 210 (enclosing the ends of the elements ub ′; individual areas of the heat exchanger 206 and / or of the part 208 of oxygéi atei r) is sheared. By this means, openings to the inner parts of the individual tubular elements of the heat exchanger 206 and / or of the oxygenator part 208 are made visible. These openings allow the thermoregulated water to flow inside the ends of the air tube elements: s of the heat exchanger 206, and for the gases to circulate inside the tubular elements of the oxygenator part 208.

After flowing through the pair of oxygenators 208 (and an optional filtering medium in certain embodiments), the blood continues to flow radially outward until it meets the wall of the housing 202. Then the san: flows out of the outlet 203o. A drain port 211 may also be included. The bleed port 211 can be used, for example, to let air exit the housing 202 while a liquid (eg, priming solution or blood) enters the housing 202. After that, the bleed port 211 can be closed.

FIG. 3 illustrates a process for priming the oxygenator 200. A priming solution is pumped into the housing 202 through the inlet port 203i. The priming solution enters the internal space 204 where it can arrive on the circulation distribution element 205. Next, the priming solution generally flows radially in the heat exchanger 206. From the heat exchanger 206, the priming solution generally flows radially in the oxygenator part 208. After passing through the oxygenator part 208, the priming solution fills the rest of the space in the housing 202, then leaves the oxygenator 200 through the evacuation orifice 203o.

As the priming solution flows as described above, the air in the housing 202 is displaced by the priming solution. At least part of the displaced air can leave the housing through the purge port 211. When the priming solution begins to exit through the purge port 211, the purge port 211 can be closed. At this point, the clinician can correctly assume that most of the air previously in housing 202 has been removed. That said, some small bubbles or air pockets may still be present in the housing 202.

In some cases, small air bubbles 212 may at least tend at the start to remain near the inlet of the heat exchanger 206. If the priming solution is allowed to flow, after a while , most or all of the small air bubbles 212 may eventually exit the housing 202. In some cases, however, some of the small bubbles 212 may remain, or the clinician may prefer not to prime long enough for all of the small air bubbles 212 flow out of the housing 202.

Referring to FIG. 4, an example of an oxygenator comprising an integrated heat exchanger 220 (or simply "an oxygenator 220") is illustrated diagrammatically. The oxygenator 220 includes a housing 222. The housing 222 defines an intake port 223i and an exhaust port 223o. A blood circulation path extends from the inlet port 223i to the outlet port 223o.

A heat exchanger 226 is disposed along the blood circulation path. As blood (or priming solution) enters housing 222 through the intake port 223i, blood generally flows ra dial .ment to heat exchanger 226, and continues to s flow radially into the heat exchanger 226. Thermoregulated water also passes through the heat exchanger 226 from an inlet port 227i to an outlet port 227o. While the heat exchanger 226 allows to transfer the heat between the thermoregulated water and the blood, the wall or walls of the heat exchanger 22 (physically separate the thermoregulated water from the blood (to prevent mixing) to 11 Conventional way of a heat exchanger. The heat exchanger 226 can be made up of metallic and / or polymeric materials. In certain embodiments, the heat exchanger 226 is manufactured with multiple small tubes. 224 is defined by the heat exchanger 226. The incoming blood flows through the internal space 224 before reaching the heat exchanger 226.

In certain embodiments, in particular the embodiment n il ustré, a circulation distribution element 225 is arranged in the space in ems. 224. Is circulation distribution element 225 configured for fac lite? a substantially uniform radial circulation distribution of blood as it enters the internal space 224 and passes to the heat exchanger 226.

An oxygenator portion 228 (which may also be referred to as a "gas exchange portion") is disposed in the housing 222 along the blood circulation path after the heat exchanger 226. In some. "Embodiments, the oxygenator part 228 is. arranged concentrically around the heat exchanger 226 so that the blood flowing radially through the heat exchanger 226 can continue to flow radially through the oxygenator portion 228. The gases also pass through the oxidizer portion 228, from an intake port 229i to an exhaust port 229o. Oxygenator portion 228 can be made of hollow fibers (membranes) that allow transfer of gases (e.g., exchanges of oxygen and carbon dioxide i re gases and blood while preventing direct mixing gas and blood.

The ends of the individual tubular elements of the hernial exchanger 226 and / or of the oxygenator part 228 can be physically linked together using a coating material 230 as described above by re-peace to the oxygenator 200. A drain port 231 may also be included. In some embodiments, an optional arterial filter medium is also included in the oxygenator 220.

Furthermore, the oxygenator 220 comprises one or more porous hollow fibers 232. In the illustrated embodiment, the porous hollow fiber or fibers 5 232 are arranged in the internal space 224 along the path, of blood circulation before the heat exchanger 226. In certain embodiments, the porous hollow fiber or fibers 232 are arranged inside the heat exchanger 226. That is to say that in certain embodiments, the porous hollow fiber or fibers 232 are interposed with the physical material (s) (eg, tubes, etc.) of the heat exchanger 226. In particular embodiments, the porous hollow fiber (s) 232 are disposed both in the internal space 224 along the blood circulation path before the heat exchanger 226 and inside the heat exchanger 226.

In some embodiments, the porous hollow fiber (s) 232 are made of polypropylene fiber. In particular embodiments, the diameter of the at least one porous hollow fiber 232 may be about 170 _è um, or from about 300 gm, or any other suitable size. The porous hollow fiber (s) 232 have pores which are sized to allow air to enter the interior of the porous hollow fiber (s) 232 while preventing liquid from entering the interior of the hollow fiber (s) Therefore, the porous hollow fiber (s) 232 can help remove air from the internal space 224. The hydrostatic pressure of the priming solution (or blood) and the dynamic pressure (derived from the amount flow movement) can each provide a driving force for air to enter the porous hollow fiber (s) 232.

The porous hollow fiber or fibers 232 have free ends 232e which are open ends. In the illustrated embodiment, the free ends 232e are located at an ambient space or around the blood oxygenator 220. Therefore, an interior portion of the porous hollow fiber (s) 232 is in fluid communication with the ambient space in or around the blood oxygenator 220. That is, the air entering the porous hollow fiber (s) 232 can exit from the free ends 232e to the ambient space in or around of the blood oxygenator 220. In some embodiments, the free ends 232e are located to ventilate in the same space as the oxygenator portion 228. That is, the air which enters the porous hollow fiber (s) 232 can exit from the free ends 232e in the same space as the oxygenator portion 228 and exit the oxygenator 220 from the 229o gas evacuation port.

In some embodiments, the ends 232e are connected: es i mie source of vacuum (not shown). Consequently, the use of the vacuum source can lead to a greater pressure differential (driving force :) in order to facilitate the elimination of air in an improved way (compared to a simple ventilation of the or porous hollow fibers 232 to the ambient atmosphere.

In certain embodiments, the hollow fiber or fibers por> use; 232 can be physically linked to the other parts of the oxygenator 220 using (at least partially) the coating material 230. In the illustrated embodiment, unlike the heat exchanger 226 and the part 228 d As the oxygenator, the ends of the porous hollow fiber or fibers 232 are not exposed by the shearing of the coating material 230 (because the free ends 232c are already exposed to the ambient atmosphere). According to a variant, or in addition, dai s and rtains embodiments the ends of one or more parts (or the early said) are discovered as a result of shearing or otherwise removal of a part ie of the coating material 230.

FIG. 5 illustrates a process for priming the oxygenator 220. A priming solution is pumped into the housing 222 through the orifice of tdm ssion 223i. The priming solution enters the internal space 224 where it can; go to the circulation distribution element 225. Next, the priming solution generally flows radially through the heat exchanger 226. From the heat exchanger 226, the priming solution generally flows radially. in the oxygenator part 228. After passing through the oxygenated portion 228 ir, the priming solution fills the rest of the space in the housing 222, I leave the oxygenator 220 through the discharge port 223o.

As the priming solution flows as described above, the air in the housing 222 is displaced by the priming solution. At black, part of the displaced air can leave the housing through the bleed port 231. When the priming solution begins to flow out through the bleed port 231, the bleed port 231 can be closed. At this point, the clinician can correctly assume that most of the air previously in the housing 222 has been eliminated. However, some small bubbles or air pockets may still be present in the housing 222.

In the illustrated embodiment, the oxygenator 220 comprises the porous hollow fiber or fibers 232. Consequently, if small bubbles or air pockets are still present in the housing 222, the air will tend to enter the or porous hollow fibers 232. After entering the or. the porous hollow fibers 232, the air will flow out of the porous hollow fiber or fibers 232 passing through the free ends 232e and towards the ambient space in or around the blood oxygenator 220. In this way, the hollow fiber or fibers 232 accelerate the elimination of air in the oxygenator 220 during the priming process. In addition, if air is or becomes entrained in the circulating blood during the medical procedure using the oxygenator 220, the porous hollow fiber (s) 232 can be used to facilitate the removal of such air.

Referring to the FÎG. 6, an oxygenator 240 given by way of example (comprising an integrated heat exchanger) is shown in an exploded view, in section and in perspective. The oxygenator 240 includes an inlet 242 for blood extending from an end wall 243, and an outlet 244 for blood extending from a peripheral housing 245. As blood flows between the inlet 242 for blood and the discharge 244 of blood, the blood passes through a heat exchanger 248 and a bundle of fibers 250 of oxygenator. In certain embodiments, one or more filter elements may also be included in the blood circulation path inside the oxygenator module 240. The heat exchanger 248 delimits the interior space 241.

In some embodiments, an optional circulation distribution element 249 may be included in the oxygenator module 240. The circulation distribution element 249 may facilitate a desired circulation distribution (eg, substantially uniform radial circulation distribution in some embodiments) blood as blood passes from the interior space 241 to the heat exchanger 248.

The oxygenator 240 also includes a first water port 246a and a second water port 246b. The water ports 246a and 246b allow the incoming flow and the outgoing flow of water to cool or heat the blood via the heat exchanger 248. The oxygenator 240 also includes a gas inlet (not visible) and a gas outlet 252. The gas inlet and outlet 252 allow the entry and exit of oxygen-rich gas to oxygenate L sai g through the fiber bundle 250 of the oxygenator. The oxvgén; tew 240 includes two end caps 247a and 247b which help structurally to hold the parts of the oxygenator module 240 together, and which delimit annular electors for water and. oxygen-rich gas. The oxygenator 240: also includes other parts such as a drain port 254, and other parts and various characteristics known to those skilled in the art.

In the illustrated embodiment, the oxygenator 240 happily includes an optional circulation distribution element 260 (which may also be referred to as a "heat exchanger body") which is disposed in the space in ern <· 241. Therefore, the circulation distribution member 260 can help the blood circulating in the internal space 241 to flow in a circulating pattern! "N substantially uniform radial after that. The circulation distribution element 26 (/ may have a frustoconical shape. In certain embodiments, the circulation distribution element 260 comprises one or more ribs 262. The: nei vures 262 can be formed and oriented on the surface external of the other parts of the circulation distribution element 260 to allow the blood circulating in the internal space 241 to substantially fill the internal space 241 before it flows in a substantially uniform radial circulation pattern thereafter.

Referring to FIG. 7, in certain embodiments the oxygen generator 240 can also comprise one or more porous hollow fibers 2 70. The porous hollow fiber or fibers 270 can be arranged in the oxygenator 240 relative to other parts of the oxygenator 240 as described above with reference to the oxygenator 220.

In the illustrated embodiment, the porous hollow fiber or fibers 270 are wound around the circulation distribution element 260. In partial embodiment, in the illustrated embodiment, the porous hollow fiber or fibers 270 are wound around the circulation distribution element 260 in a pattern entered. Such a crisscross pattern can be a helical pattern. In certain embodiments, the winding density of the porous hollow fiber or fibers 270 at the level of the terminal parts of the circulation distribution element 260 can be increased relative to the winding density of the at least one hollow fibers poreu -es 270 inside from the terminal parts. Any suitable winding pattern (eg pitch, angle, number of turns, spacing between turns and the like can be used. Any number of filaments (individual hollow fibers) can be used. example, without limitation, in some cases one filament, two filaments, four filaments, eight filaments, sixteen filaments, thirty-two filaments (or any other number of filaments) may be used (and wound in a desired pattern).

When a crisscross pattern is used (eg, as shown without limitation in FIG. 7), cross communication between the filaments of the porous hollow fiber (s) 270 can advantageously be created in some cases. Namely, the intersections of microporous fibers can create a gas communication bridge that can let a gas (e.g., air) pass not only along the longitudinal direction of the fiber, but in the radial direction (between adjacent fibers). This communication can be very useful for ventilating the porous hollow fiber or fibers 270 between the path of blood and the atmosphere. Instead of all the fibers needing to ventilate out of the oxygenator 240, a reduced number of the porous hollow fiber or fibers 270 can be used to evacuate the trapped air. This characteristic can also contribute to the manufacturability in certain cases.

In some embodiments, the porous hollow fiber (s) 270 may be disposed within the oxygenator 240 in an uncrossed pattern. In certain embodiments, the longitudinal axes of the porous hollow fiber or fibers 270 can be parallel to the central longitudinal axis of the oxygenator 240. In certain such embodiments, the longitudinal axes of the hollow fiber or fibers 270 can be oriented at a non-zero angle (e.g., between approximately 0 ° and 10 °, or between approximately 5 ° and 15 °, or between approximately 10 ° and. 20 °, or between approximately 15 ° and 25 °, or between about 20 ° and 30 °, and so on) relative to the longitudinal central axis of the oxygenator 240. In certain embodiments, the porous hollow fiber or fibers 270 may be a mat of hollow fibers. One or more layers of such a hollow fiber mat can be used.

In some embodiments, the hollow fiber (s) 270 may be used for gas transfer purposes such as, but not limited to, oxygenating the blood and / or removing carbon dioxide from the blood.

FIG. 8 is a photograph of a terminal portion of an extracorporeal oxygenator 300 (and of an integrated heat exchanger) which includes an integrated air removal structure, in accordance with certain embodiments provided herein. The end cap of the oxygenator 300 is not included in the photograph in order to allow a better visualization of the following and mps> health of the oxygenator 300.

The oxygenator 300 comprises an oxygenator section 310, a thermal changer 320, a circulation distribution element 330 and one or more porous hollow fibers 340. In the illustrated embodiment, notches 33 / are included in a end of the circulation distribution element / 30. In some embodiments, the notches 332 are created (eg, machined;) after the coating process so that the open ends of the porous hollow fiber (s) 340 are thus created to allow ventilation of the air from the porous hollow fiber or fibers 340 to the atmosphere.

While this description contains many specific implementation details, these should not be interpreted as limitations on the scope of any invention or what can be claimed, but rather as descriptions of features which may be specific. to particular embodiments of particular inventions. Certain characteristics: that are described in the present description in the context of embodiments! dif tincts can also be implemented together in a single embodiment. Conversely, various features which are described in the context of a: an embodiment can also be implemented in multiple realization weddings separately or in any secondary acapt.ee combination. Furthermore, although characteristics may be described here as acting in certain combinations and even claimed initially as such:, one or more characteristics of a claimed combination may in this case be excluded from the combination, and the combination claimed may relate to a secondary combination or a variation of a secondary combination.

Likewise, although operations are illustrated in the drawings d ms: m particular order, this should not be understood as if such operations were necessarily to be carried out in the particular order indicated or in the sequential order, or that all the operations illustrated are carried out, in order to obtain <the desired results. In certain circumstances, the production of several files and a parallel processing may be advantageous. In addition, the separation of the various modules and components of the system in the embodiments described herein should not be interpreted as if such separation were necessary in all embodiments, and it should be understood that the components and the systems described in the program can generally be integrated together in a single product or packaged in several products.

Particular embodiments of the subject have been described. Other embodiments are within the scope of the following claims. For example, the actions set out in the claims can be performed in a different order and still achieve the desired results. For example, the processes illustrated in the accompanying figures do not particularly require the particular order shown, or the sequential order, to achieve desired results. In certain implementations, the performance of several tasks and parallel processing 10 may be advantageous.

Claims (20)

1. Blood oxygenator, comprising: a blood inlet and a blood outlet, a blood circulation path extending from the blood inlet to the blood outlet; a portion of gas exchanges arranged along the path of blood circulation; a heat exchange part disposed along the blood circulation path before the gas exchange part; and one or more porous hollow fibers disposed along the blood flow path before the heat exchange portion. 2. A blood oxygenator according to claim 1, wherein an inner portion of the porous hollow fiber (s) communicates with an ambient space in or around the blood oxygenator. The blood oxygenator according to claim 1, wherein an inner portion of the porous hollow fiber (s) communicates with a source of x ide. 4. A blood oxygenator according to claim 1, also comprising a circulation distribution element disposed along the path of circulation of the blood before the porous hollow fiber or fibers. 5. A blood oxygenator according to claim 4, in which the porous hollow fiber or fibers are wound around the circulating distribution element. 6. The blood oxygenator according to claim 5, wherein the porous hollow fiber or fibers are wound around the circui dior delivery element in a crisscrossed helical pattern. 7. A blood oxygenating device according to claim 4, in which the porous hollow fiber or fibers are arranged around the circulation distribution element in a non-crossed pattern. 8. The blood oxygenator of claim 1, wherein the pores of the porous hollow fiber (s) allow air to enter the interior of the porous hollow fiber (s) while preventing liquid from entering the interior porous hollow fiber (s). 9. Blood oxygenator, comprising: a housing defining a blood intake port and a blood discharge port; a heat exchanger disposed in the housing, the heat exchanger defining an internal space; a membrane oxygenator part disposed in the housing, the oxygenator part being arranged concentrically around the heat exchanger; and one or more porous hollow fibers disposed in the internal space. 10. A blood oxygenator according to claim 9, further comprising a circulation distribution element disposed in the internal space. 11. A blood oxygenator according to claim 10, wherein the porous hollow fiber or fibers are wound around the circulation delivery element. The blood oxygenator according to claim 11, wherein the circulation distribution element is configured to facilitate a substantially uniform radial circulation distribution of the blood entering the heat exchanger. The blood oxygenator according to claim 9, wherein an inner portion of the porous hollow fiber (s) communicates with an ambient space in or around the blood oxygenator. 14. The blood oxygenator of claim 9, wherein an interior portion of the porous hollow fiber (s) communicates with a source of vacuum. 15. The blood oxygenator according to claim 9, wherein the porous hollow fiber or fibers are arranged in a crisscross pattern. 16. The blood oxygenator of claim 9, wherein the porous hollow fibers are arranged in a non-cross pattern. 17. A method of configuring a blood oxygenator, the method consisting in: have a membrane oxygenator in a housing which defines:; : () an admission of blood, (ii) an evacuation of blood and (iii) a sarguine circulation path extending from the admission of blood towards the evacuation of blood; have a heat exchanger along the sarguine circulation path before the membrane oxygenator; and placing one or more porous hollow fibers along the blood circulation path before the heat exchanger. 18. The method of claim 17, wherein the one or more digging fibers are arranged so that an interior portion of the one or more porous fibers communicates with an ambient space in or around the blood oxygenator. 19. The method of claim 17, further providing a blood circulation distribution element along the blood circulation path before the porous hollow fiber (s), and wherein the porous hollow fiber (s) are wrapped around the element circulation distribution. 20. The method of claim 17, wherein the pores of the porous hollow fiber (s) allow air to enter the interior of the porous hollow fiber (s) while preventing liquid from entering the interior. the porous hollow fiber or fibers.