JP2019072489A - Extracorporeal oxygenator with integrated ventilation system - Google Patents

Abstract

To provide extracorporeal heat exchange and oxygenation devices which can be used for on-pump open-heart surgery to facilitate surgical procedures such as coronary artery bypass surgery.SOLUTION: An oxygenator apparatus 220 comprises a gas exchange unit 228, a heat exchange unit 226, and an integrated ventilation structure disposed in front of the heat exchange unit. The integrated ventilation structure includes one or more porous hollow fibers 232.SELECTED DRAWING: Figure 4

Description

[Cross-reference to related applications]
This application claims the benefit of US Provisional Application No. 62 / 572,754, filed Oct. 16, 2017. The disclosure of the prior application is considered part of the disclosure of the present application (and is incorporated into the present application by reference).

  The present application relates to a device used during surgery for the treatment of heart disease. For example, the present application relates to extracorporeal heat exchange and oxygen delivery devices that can be used for on-pump open-heart surgery to facilitate surgery such as coronary artery bypass surgery. Some extracorporeal heat exchange and oxygenation devices described herein include integrated air removal structures.

  Hollow fiber oxygenators are utilized in the extracorporeal circuit to meet the patient's gas exchange requirements during cardiopulmonary bypass surgery. The blood from the patient may be drained by gravity or used to obtain the flow required to maintain a sufficient volume in the vessel by vacuum assisted venous drainage (VAVD). A pump (eg, a peristaltic pump or centrifugal pump coupled to a magnetic drive) is used in the main line of the circuit to draw blood from the container and finally back to the patient via the oxygenator.

  Prior to the onset of bypass, crystalloid priming fluid is pumped through the extracorporeal circuit to remove air from the circuit components. In some cases, it may be difficult to remove a significant amount of air in the oxygenator during the priming process.

  The present application describes a device used during surgery for the treatment of heart disease. For example, the present application describes extracorporeal heat exchange and oxygen delivery devices that can be used for on-pump open-heart surgery to facilitate surgery such as coronary artery bypass surgery. The extracorporeal heat exchange and oxygen delivery devices described herein can include an integrated air removal structure.

  According to one aspect, the present disclosure is directed to a blood oxygenator including a blood inlet and a blood outlet. A blood flow path extends from the blood inlet to the blood outlet. The blood oxygen supply apparatus further includes a gas exchange unit disposed along the blood flow path, a heat exchange unit disposed before the gas exchange section along the blood flow passage, and a heat exchange along the blood flow path. And one or more porous hollow fibers disposed prior to the part.

  Such a blood oxygenator may optionally include one or more of the following features. The interior of the one or more porous hollow fibers may be in communication with the environmental space inside or around the blood oxygenator. The interior of the one or more porous hollow fibers may be in communication with a vacuum source. The blood oxygenator may also include a flow distribution element positioned along the blood flow path prior to the one or more porous hollow fibers. In some embodiments, one or more porous hollow fibers are wound on the flow distribution element. One or more porous hollow fibers may be wound around the flow distribution element in a spiral pattern that intersects. One or more porous hollow fibers may be arranged around the flow distribution element in a non-intersecting helical pattern. The pores of the one or more porous hollow fibers allow air to enter inside the one or more porous hollow fibers while the liquid enters the inside of the one or more porous hollow fibers To prevent.

  According to another aspect, the present disclosure provides (i) a housing defining a blood inlet and a blood outlet, (ii) a heat exchanger disposed within the housing and defining an interior space, (iii) To a blood oxygenator comprising a membrane oxygenator arranged in a housing and arranged concentrically around the heat exchanger, and (iv) one or more porous hollow fibers arranged in the inner space Be

  Such a blood oxygenator may optionally include one or more of the following features. The blood oxygenator may also include a flow distribution element disposed within the interior space. One or more porous hollow fibers may be wound around the flow distribution element. The flow distribution element may be configured to promote a substantially uniform radial flow distribution of blood entering the heat exchanger. The interior of the one or more porous hollow fibers may be in communication with the environmental space inside or around the blood oxygenator. The interior of the one or more porous hollow fibers may be in communication with a vacuum source. One or more porous hollow fibers may be arranged in a cross pattern. The one or more porous hollow fibers may be arranged in a non-intersecting pattern.

  According to another aspect, the present disclosure is directed to a method of configuring a blood oxygenator. The method comprises a housing defining a membrane oxygenator (i) a blood inlet, (ii) a blood outlet, and (iii) a blood flow path extending from the blood inlet to the blood outlet. Placing the heat exchanger prior to the membrane oxygenator along the blood flow path, and one or more porous hollow fibers prior to the heat exchanger along the blood flow path. And placing.

  Such a method may optionally include one or more of the following features. The one or more porous hollow fibers may be arranged such that the interior of the one or more porous hollow fibers is in communication with the environmental space inside or around the blood oxygenator. The method may also include configuring an oxygen supply for connecting one or more porous hollow fibers to a vacuum source. The method may also include disposing the flow distribution element prior to the one or more porous hollow fibers along the blood flow path. One or more porous hollow fibers may be wound around the flow distribution element. One or more porous hollow fibers may be wound around the flow distribution element in a spiral pattern that intersects. At least some of the intersecting porous hollow fibers may be fluidly connected to one another by the contact between each other. One or more porous hollow fibers may be arranged around the flow distribution element in a non-intersecting helical pattern. The pores of the one or more porous hollow fibers allow air to enter inside the one or more porous hollow fibers while the liquid enters the inside of the one or more porous hollow fibers To prevent.

  Particular embodiments of the subject matter described in this application can be implemented to realize one or more of the following advantages. In some embodiments, using the devices and methods provided herein, a patient can undergo open heart surgery that is less likely to have an adverse effect. For example, with some embodiments described herein, the patient is less exposed to the possibility of air embolism from the extracorporeal circuit. Thus, the risk of anoxia (eg, stroke and other types of tissue ischemia) may be reduced. In addition, in some instances, it may be possible to reduce the time the clinician spends priming the circuit to ensure sufficient removal of air in the extracorporeal circuit. Thus, relatively low cost surgery can be performed and the risk of clinician error can be reduced. Furthermore, with some embodiments described herein, the use of a simplified extracorporeal circuit is possible as compared to a conventional extracorporeal circuit using an additional air removal device. Additionally, the air removal structures described herein facilitate the use of low cost oxygen delivery devices. Such low cost devices can provide less dilution of the patient's blood as compared to conventional extracorporeal circuits. The low blood dilution reduces the likelihood that the patient's hemagrit value will fall below the critical value, thus the patient is less likely to need blood transfusion.

  Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although methods and materials similar or equivalent to those described herein can be used in the practice of the invention, suitable methods and materials are described herein. All documents, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

  The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description herein. Other features, objects, and advantages are apparent from the description and drawings, and from the claims.

FIG. 1 is a schematic view of a patient undergoing open-heart surgery while being assisted with an extracorporeal circuit, according to some embodiments described herein. FIG. 2 is a schematic view of an extracorporeal oxygenator (and an integrated heat exchanger) according to some embodiments described herein. FIG. 3 is a view schematically showing a priming process of the extracorporeal oxygenator of FIG. FIG. 4 is a schematic view of an extracorporeal oxygenator (and an integrated heat exchanger) including an integrated air removal structure, according to some embodiments described herein. FIG. 5 is a view schematically showing a priming process of the extracorporeal oxygenator of FIG. FIG. 6 is an exploded cross-sectional perspective view of the extracorporeal oxygenator (and the integrated heat exchanger). FIG. 7 is an exploded cross-sectional perspective view of an extracorporeal oxygenator (and an integral heat exchanger) including an integral air removal structure according to some embodiments described herein. FIG. 8 is a photograph of an end of an extracorporeal oxygenator (and an integral heat exchanger) including an integral air removal structure, according to some embodiments described herein.

  Like numbers refer to corresponding parts throughout.

  The present application describes a device used during surgery for the treatment of heart disease. For example, the present application describes extracorporeal heat exchange and oxygen delivery devices that can be used for on-pump open-heart surgery to facilitate surgery such as coronary artery bypass surgery. Some of the extracorporeal heat exchange and oxygenation devices described herein may include an integrated air removal structure.

  Referring to FIG. 1, a patient 10 can receive treatment using the illustrated extracorporeal blood flow circuit 100. In this illustrative example, patient 10 is undergoing cardiac bypass surgery using extracorporeal blood flow circuit 100. The circuit 100 is connected to the patient 10 at the patient's heart 12. Blood from the patient 10 is drawn from the patient 10 at the patient's heart 12 and blood is circulated through the circuit 100 before blood is returned to the patient's heart 12.

  The illustrated extracorporeal blood flow circuit 100 includes 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. Venous tube 110 is in physical contact with heart 12 and in fluid communication with the venous side of the patient's 10 circulatory system. Venous tube 110 is also in fluid communication with the inlet of reservoir 120. The outlet from the storage container 120 is connected to the inlet of the pump 130 by a tube. The outlet of pump 130 is connected to the tube to the inlet of oxygenator 140. The outlet of the oxygenator 140 is connected by a tube to the inlet of the arterial filter 150. The outlet of the arterial filter 150 (optional) is connected to the arterial tube 160. An arterial tube 160 is in physical contact with the heart 12 and in fluid communication with the arterial side of the patient 10 circulatory system.

  Briefly, extracorporeal blood flow circuit 100 operates by drawing venous blood from patient 10 via venous tube 110. Blood from the venous tube 110 is stored in the reservoir 120. At least some amount of blood is to be maintained in the reservoir 120 at all times during a medical procedure. The blood of the reservoir 120 is drawn from the reservoir 120 by the pump 130. The pressure generated by the pump 130 drives blood through the oxygenator 140. In the oxygenator 140, the venous blood is enriched with oxygen. In addition, with the heat exchangers incorporated into the oxygenator 140, it may be possible to selectively raise or lower the temperature of the blood. Oxygenated arterial blood exits the oxygenator 140, travels through the arterial filter 150, and is infused into the patient's heart 12 via the arterial tube 160.

  Those skilled in the art will recognize that, prior to use, extracorporeal blood flow circuit 100 initially contains air that must be removed before circuit 100 can be connected to patient 10. A priming solution is introduced into the circuit 100 to remove air in the circuit 100. This process is referred to as priming the circuit 100.

  An example of an oxygenator 200 (or simply "oxygenator 200") with an integrated heat exchanger is schematically illustrated in FIG. The oxygen supply device 200 includes a housing 202. The housing 202 defines an inlet 203 i and an outlet 203 o. The blood flow path extends from the inlet 203i to the outlet 203o.

  The heat exchanger 206 is disposed along the blood flow path. When blood (or priming fluid) enters the housing 202 through the inlet 203i, the blood generally flows radially toward the heat exchanger 206 and continuously flows into the heat exchanger 206 radially. Do. Temperature controlled water also passes through the heat exchanger 206 from the inlet 207 i to the outlet 207 o (or in the reverse direction). While the heat exchanger 206 allows heat exchange between the temperature controlled water and the blood, the walls of the heat exchanger 206 blood the temperature controlled water in a manner typical of a heat exchanger. Physically separate from (to prevent mixing). The heat exchanger 206 can be composed of metal or polymer material. In some embodiments, the heat exchanger 206 is comprised of a plurality of thin tubes. Internal space 204 is defined by heat exchanger 206. Inflowing blood flows in the internal space 204 before reaching the heat exchanger 206.

  In some embodiments, the flow distribution element 205 is disposed in the interior space 204. The flow distribution element 205 is configured to promote a substantially uniform radial flow distribution of blood as it moves into and into the interior space 204 and into the heat exchanger 206.

  An oxygen supply 208 (also referred to as a “gas exchange”) is disposed inside the housing 202 after the heat exchanger 206 along the blood flow path. In some embodiments, the oxygen supply 208 is a heat exchanger such that blood flowing radially through the heat exchanger 206 can continuously flow radially through the oxygen supply 208. They are arranged concentrically around 206. Gas is also passed from inlet 209 i to outlet 209 o via oxygen supply 208. Oxygen supply 208 can be comprised of hollow fibers (membranes) that allow gas transfer between gas and blood (eg exchange of oxygen and carbon dioxide) while preventing mixing of gas and blood .

  In some embodiments, the ends of the individual tubular elements of heat exchanger 206 and / or oxygen supply 208 are physically coupled using filler 210. Filler 210 may, in some instances, be urethane. After the filler 210 is applied (with fluidity) to the ends of the individual tubular elements of the heat exchanger 206 and / or the oxygen supply 208, the filler 210 can be solidified. . In the solid state, the filler 210 is trimmed (wrapping the ends of the individual tubular elements of the heat exchanger 206 and / or the oxygen supply 208). In so doing, the openings to the interior of the individual tubular elements of the heat exchanger 206 and / or the oxygen supply 208 are exposed. These openings allow temperature controlled water to flow inside the tubular element of heat exchanger 206 and allow gas to flow inside the tubular element of oxygen supply 208.

  Blood flows through the oxygen supply 208 (and, in some embodiments, an optional filter material) and then continues radially outward until it hits the wall of the housing 202. Thereafter, the blood flows out from the outlet 203o. The removal port 211 may also be included. The removal port 211 can be used, for example, to allow air to escape from the housing 202 while fluid (eg, priming fluid or blood) is flowing into the housing 202. Thereafter, the removal port 211 can be closed.

  FIG. 3 illustrates the priming process of the oxygenator 200. The priming solution is supplied from the inlet 203 i into the housing 202 by a pump. The priming solution can enter the interior space 204 where it can strike the flow distribution element 205. The priming fluid then generally flows into the heat exchanger 206 radially. From the heat exchanger 206, the priming fluid normally flows into the oxygen supply 208 in the radial direction. After passing through the oxygen supply 208, the priming solution fills the remainder of the space in the housing 202 and then exits the oxygenator 200 through outlet 203o.

  As the priming fluid flows as described above, the air in the housing 202 is replaced with the priming fluid. At least some of the displaced air can exit the housing through the removal port 211. Once the priming fluid begins to emerge from the removal port 211, the removal port 211 can be closed. At that point, the clinician can correctly infer that most of the air previously contained within the housing 202 has been removed. However, small bubbles or cavities may still be present in the housing 202.

  In some cases, small air bubbles 212 may tend to remain near the inlet of heat exchanger 206, at least initially. If it is possible for the priming solution to flow continuously, after some time most or all of the small air bubbles 212 may eventually flow out of the housing 202. However, in some cases, some of the small bubbles 212 may remain, or the clinician does not want to prime for a sufficiently long time for all of the small bubbles 212 to drain out of the housing 202 There is also the possibility.

  An example of an oxygenator 220 (or simply "oxygenator 220") with an integrated heat exchanger is schematically illustrated in FIG. The oxygen supply device 220 includes a housing 222. The housing 222 defines an inlet 223i and an outlet 223o. The blood flow path extends from the inlet 223i to the outlet 223o.

  The heat exchanger 226 is disposed along the blood flow path. When blood (or priming fluid) enters the housing 222 through the inlet 223i, the blood generally flows radially toward the heat exchanger 226 and continuously flows radially into the heat exchanger 226. Do. Temperature controlled water also passes through heat exchanger 226 from inlet 227i to outlet 227o. While the heat exchanger 226 enables heat exchange between temperature controlled water and blood, the walls of the heat exchanger 226 heat the temperature controlled water in a manner typical of a heat exchanger. Physically separate from (to prevent mixing). The heat exchanger 226 can be comprised of metal and / or polymer material. In some embodiments, the heat exchanger 226 is comprised of a plurality of thin tubes. Internal space 224 is defined by heat exchanger 226. Inflowing blood flows through the internal space 224 before reaching the heat exchanger 226.

  In some embodiments, such as the illustrated embodiment, the flow distribution element 225 is disposed in the interior space 224. The flow distribution element 225 is configured to promote a substantially uniform radial flow distribution of blood as it moves into the interior space 224 and into the heat exchanger 226.

  An oxygen supply 228 (also referred to as a “gas exchange”) is disposed within the housing 222 along the blood flow path after the heat exchanger 226. In some embodiments, the oxygen supply 228 is a heat exchanger such that blood flowing radially through the heat exchanger 226 may continuously flow radially through the oxygen supply 228. They are arranged concentrically around 226. Gas is also passed from inlet 229i to outlet 229o via oxygen supply 228. Oxygen supply 228 may be comprised of hollow fibers (membranes) that allow gas transfer between gas and blood (eg exchange of oxygen and carbon dioxide) while preventing mixing of gas and blood. .

  The ends of the individual tubular elements of the heat exchanger 226 and / or the oxygen supply 228 may be physically coupled with the filler 230 as described above with reference to the oxygenator 200. Moreover, the removal port 231 may also be included. In some embodiments, an optional arterial filter is also included in the oxygenator 220.

  Additionally, the oxygenator 220 includes one or more porous hollow fibers 232. In the illustrated embodiment, one or more porous hollow fibers 232 are disposed in the interior space 224 along the blood flow path prior to the heat exchanger 226. In some embodiments, one or more porous hollow fibers 232 are disposed within the heat exchanger 226. That is, in some embodiments, one or more porous hollow fibers 232 are interspersed with the physical material (eg, tubes, etc.) of heat exchanger 226. In certain embodiments, one or more porous hollow fibers 232 are disposed along the blood flow path in the interior space 224 prior to the heat exchanger 226 and also within the heat exchanger 226 .

  In some embodiments, one or more porous hollow fibers 232 are formed of polypropylene fibers. In certain embodiments, the diameter of the one or more porous hollow fibers 232 may be about 170 μm, or about 300 μm, or some other suitable size. The one or more porous hollow fibers 232 allow air to enter inside the one or more porous hollow fibers 232 while the liquid enters the inside of the one or more porous hollow fibers 232 It has pores of a size to prevent. Thus, the one or more porous hollow fibers 232 facilitate the removal of air from the interior space 224. The hydrostatic pressure and the dynamic pressure (from the momentum of the flow) of the priming fluid (or blood) can provide the impetus for air to enter the one or more porous hollow fibers 232, respectively.

  The one or more porous hollow fibers 232 have free ends 232 e that are open ends. In the illustrated embodiment, the free end 232e is located in the environmental space inside or around the blood oxygenator 220. Thus, the interior of the one or more porous hollow fibers is fluidly coupled to the environmental space within or around the blood oxygenator 220. That is, air entering one or more porous hollow fibers 232 can exit the environmental space inside or around the blood oxygenator 220 from the free end 232e. In some embodiments, the free end 232 e is positioned to ventilate the same space as the oxygen supply 228. That is, air entering one or more of the porous hollow fibers 232 can exit the same space as the oxygen supply 228 from the free end 232e and can exit the oxygenator 220 from the gas outlet 229o.

  In some embodiments, free end 232e is connected to a vacuum source (not shown). Thus, the use of a vacuum source results in a greater pressure differential (propulsive force) and can facilitate the removal of air in a better manner (simply ventilate one or more porous hollow fibers 232 to the surrounding atmosphere Compared to that).

  In some embodiments, one or more porous hollow fibers 232 may be physically coupled to other portions of the oxygenator 220 using (at least partially) the filler 230. In the illustrated embodiment, unlike the heat exchanger 226 and the oxygen supply 228, the ends of the one or more porous hollow fibers 232 are not exposed by the shear of the filler 230 (since the free end 232e is already ambient). Because it is exposed to the atmosphere). Alternatively, or additionally, in some embodiments, the ends of one or more portions (or all) are exposed as a result of the shear of filler 230 or otherwise removing some.

  FIG. 5 illustrates the priming process of the oxygenator 220. The priming solution is supplied by a pump from the inlet 223 i into the housing 222. The priming solution can enter the interior space 224 where it can strike the flow distribution element 225. The priming fluid then generally flows into the heat exchanger 226 radially. From the heat exchanger 226, the priming fluid generally flows into the oxygen supply 228 in a radial direction. After passing through the oxygen supply 228, the priming solution fills the remainder of the space in the housing 222 and then exits the oxygenator 220 from the outlet 223o.

  As the priming fluid flows as described above, the air in the housing 222 is replaced with the priming fluid. At least some of the displaced air can exit the housing through the removal port 231. Once the priming fluid begins to emerge from the removal port 231, the removal port 231 can be closed. At that point, the clinician can correctly deduce that most of the air previously contained within the housing 222 has been removed. However, small bubbles or cavities may still be present in the housing 222.

  In the illustrated embodiment, the oxygenator 220 includes one or more porous hollow fibers 232. Thus, if small bubbles or cavities are still present in the housing 222, the air will tend to enter one or more porous hollow fibers 232. After entering the one or more porous hollow fibers 232, air can exit the environmental space inside or around the blood oxygenator 220 from the one or more porous hollow fibers 232 via the free end 232e. . In this way, the one or more porous hollow fibers 232 facilitate the removal of air within the oxygenator 220 during the priming process. In addition, if air is present in or circulating with the circulating blood during a medical procedure using the oxygenator 220, one or more of the porous hollow fibers 232 can be Works to remove such air.

  An example of an oxygenator 240 (including an integrated heat exchanger) is shown in an exploded cross-sectional perspective view in FIG. The oxygenator 240 includes a blood inlet 242 extending from the end wall 243 and a blood outlet 244 extending from the peripheral housing 245. As blood flows between blood inlet 242 and blood outlet 244, blood passes through heat exchanger 248 and oxygenator fiber bundle 250. In some embodiments, one or more filter members may be included in the blood flow path within the oxygenator module 240. The heat exchanger 248 defines an internal space 241.

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

  The oxygenator 240 also includes a first water outlet 246a and a second water outlet 246b. The water outlets 246a and 246b allow the inflow and outflow of water to cool or heat the blood via the heat exchanger 248. Oxygen supply 240 also includes a gas inlet (not shown) and a gas outlet 252. The gas inlets and gas outlets 252 allow the inflow and outflow of oxygen enriched gas to oxygenate blood via the oxygenator fiber bundle 250. The oxygenator 240 includes two end caps 247a and 247b that help hold structurally the portions of the oxygenator module 240 and define an annular manifold for water and oxygen enriched gas. Oxygen supply 240 also includes other portions, such as removal port 254, and various other portions known to those skilled in the art.

  In the illustrated embodiment, the oxygenator 240 also includes an optional flow distribution element 260 (also referred to as a "heat exchanger body") disposed within the interior space 241. Thus, the flow distribution element 260 can then facilitate the flow of blood into the interior space 241 in a substantially uniform radial flow pattern. The flow distribution element 260 is frusto-conical. In some embodiments, flow distribution element 260 includes one or more ribs 262. Ribs 262 are other members of flow distribution element 260 to allow blood to flow into interior space 241 to substantially fill interior space 241 before blood flows in a substantially uniform radial flow pattern. It can be formed on the outer surface of the part and can be oriented.

  As shown in FIG. 7, in some embodiments, the oxygenator 240 also includes one or more porous hollow fibers 270. One or more porous hollow fibers 270 may be disposed within the oxygenator 240 relative to the other portions of the oxygenator 240 as described above with reference to the oxygenator 220.

  In the illustrated embodiment, one or more porous hollow fibers 270 are wound around the flow distribution element 260. In particular, in the illustrated embodiment, one or more porous hollow fibers 270 are wound around the flow distribution element 260 in a cross pattern. Such crossing patterns may be helical patterns. In some embodiments, at the end of the flow distribution element 260, the winding density of the one or more porous hollow fibers 270 is higher compared to the winding density of the one or more porous hollow fibers 270 inside the end. It has become. Any suitable winding pattern (eg, pitch, angle, number of turns, spacing between turns, etc.) can be used. Any number of fibers (individual hollow fibers) can be used. For example, without limitation, in some examples, one fiber, two fibers, four fibers, eight fibers, sixteen fibers, thirty-two fibers (or any other A number of fibers can be used (and wound in the desired pattern).

  When a cross pattern is used (e.g., as illustrated in, but not limited to, FIG. 7), in some cases cross communication between fibers of one or more porous hollow fibers 270 is preferably formed It may be done. That is, the points of intersection of the microporous fibers can form gas communication bridges that allow gas (e.g., air) to move in the radial direction of the fibers as well as in the radial direction (between adjacent fibers). This communication may be very useful for venting one or more porous hollow fibers 270 from the blood flow path to the atmosphere. Instead of all the fibers that need to be vented from the oxygenator 240, a smaller number of one or more porous hollow fibers 270 can be used to evacuate entrapped air. This feature can, in some cases, help ease of manufacture.

  In some embodiments, one or more porous hollow fibers 270 can be disposed within the oxygenator 240 in a non-intersecting pattern. In some such embodiments, the longitudinal axis of the one or more porous hollow fibers 270 may be parallel to the central longitudinal axis of the oxygenator 240. In some such embodiments, the longitudinal axis of the one or more porous hollow fibers 270 is at a non-zero angle (eg, about 0 to 10 degrees) with respect to the central longitudinal axis of the oxygenator 240. Between about 5 degrees to 15 degrees, or about 10 degrees to 20 degrees, or about 15 degrees to 25 degrees, or about 20 degrees to 30 degrees, etc.). In some embodiments, one or more porous hollow fibers 270 can be a mat of hollow fibers. One or more layers of such hollow fiber mats may be used.

  In some embodiments, one or more porous hollow fibers 270 are used for gas transfer purposes such as, but not limited to, binding of blood to oxygen and / or removal of carbon dioxide from blood. obtain.

  FIG. 8 is a photograph of an end of an extracorporeal oxygenator 300 (and an integral heat exchanger) including an integral air removal structure, according to some embodiments described herein. The end caps of the oxygenator 300 are not included in the photograph, in order to be able to better visualize the following components of the oxygenator 300.

  Oxygen supply 300 includes an oxygen supply 310, a heat exchanger 320, a flow distribution element 330, and one or more porous hollow fibers 340. In the illustrated embodiment, a notch 332 is included at the end of the flow distribution element 330. In some embodiments, notches 332 are formed (eg, processed) after the filling process, whereby the open end of the one or more porous hollow fibers 340 are used to transmit air from the one or more porous hollow fibers 340 to the atmosphere. Formed to allow for discharge.

  Although the specification includes particular implementation details, these should not be construed as limitations on the scope of the invention or of the claimed scope, but rather is specific to particular embodiments of the particular invention. It can be interpreted as an explanation of possible features. Certain features that are described in this specification in the context of separate embodiments can also be combined and implemented in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in appropriate subcombinations. Furthermore, although features may be described and claimed initially as working in a combination, in some cases, more than one feature may be cut from the combination from the claimed combination. Also, claimed combinations may be directed to variations of subcombinations or subcombinations.

  Similarly, in the figures, the operations are illustrated in a particular order, but this may be done in a particular order or sequence as such operations are illustrated, in order to obtain the desired result. It should not be understood that it needs to be understood or that all the illustrated operations need to be performed. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments, and the described program components and systems It should be understood that, in general, they may be integrated in a single product or packaged into multiple products.

  While certain embodiments of the subject matter have been described, other embodiments are within the scope of the following claims. For example, the operations recited in the claims may be performed in a different order and still achieve the desired results. By way of example, the processes depicted in the accompanying drawings do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous.

Claims (20)

A blood oxygen supply device,
A blood inlet and a blood outlet, and a blood flow path extending from the blood inlet to the blood outlet;
A gas exchange unit disposed along the blood flow path;
A heat exchange unit disposed in front of the gas exchange unit along the blood flow path;
And at least one porous hollow fiber disposed in front of the heat exchange part along the blood flow path.   The blood oxygenator according to claim 1, wherein the interior of the one or more porous hollow fibers is in communication with the environmental space inside or around the blood oxygenator.   The blood oxygenator according to claim 1, wherein the interior of the one or more porous hollow fibers is in communication with a vacuum source.   The blood oxygenation device according to claim 1, further comprising a flow distribution element positioned in front of the one or more porous hollow fibers along the blood flow path.   5. The blood oxygenator according to claim 4, wherein the one or more porous hollow fibers are wound around the flow distribution element.   6. The blood oxygenator according to claim 5, wherein the one or more porous hollow fibers are wound around the flow distribution element in an intersecting spiral pattern.   5. The blood oxygenator according to claim 4, wherein the one or more porous hollow fibers are arranged around the flow distribution element in a non-intersecting pattern.   The pores of the one or more porous hollow fibers allow air to enter the inside of the one or more porous hollow fibers while the liquid enter the inside of the one or more porous hollow fibers The blood oxygen supply device according to claim 1, which prevents A blood oxygen supply device,
A housing defining a blood inlet and a blood outlet;
A heat exchanger disposed in the housing and defining an internal space;
A membrane oxygen supply unit disposed in the housing and disposed concentrically around the heat exchanger;
A blood oxygenator including one or more porous hollow fibers disposed in the interior space.   10. The blood oxygenator according to claim 9, further comprising a flow distribution element disposed in the interior space.   11. The blood oxygenator according to claim 10, wherein the one or more porous hollow fibers are wound around the flow distribution element.   12. The blood oxygenator according to claim 11, wherein the flow distribution element is configured to promote a substantially uniform radial flow distribution of blood entering the heat exchanger.   10. The blood oxygenator according to claim 9, wherein the inside of the one or more porous hollow fibers is in communication with the environmental space inside or around the blood oxygenator.   10. The blood oxygenator according to claim 9, wherein the interior of the one or more porous hollow fibers is in communication with a vacuum source.   10. The blood oxygenator according to claim 9, wherein the one or more porous hollow fibers are arranged in a cross pattern.   10. The blood oxygenator according to claim 9, wherein the one or more porous hollow fibers are arranged in a non-intersecting pattern. A method of constructing a blood oxygenator comprising
Disposing a membrane oxygenator in a housing defining (i) a blood inlet, (ii) a blood outlet, and (iii) a blood flow path extending from the blood inlet to the blood outlet. When,
Placing a heat exchanger prior to the membrane oxygenator along the blood flow path;
Placing one or more porous hollow fibers along the blood flow path prior to the heat exchanger.   18. The one or more porous hollow fibers according to claim 17, wherein the one or more porous hollow fibers are arranged such that the inside of the one or more porous hollow fibers is in communication with the environmental space inside or around the blood oxygenator. Method.   The method further includes disposing a flow distribution element along the blood flow path prior to the one or more porous hollow fibers, wherein the one or more porous hollow fibers are wound around the flow distribution element. The method of claim 17.   The pores of the one or more porous hollow fibers allow air to enter the inside of the one or more porous hollow fibers while the liquid enter the inside of the one or more porous hollow fibers 21. The method of claim 17 to prevent.