CN109793956A - Extracorporeal oxygenation device with integrated air removal system - Google Patents

Extracorporeal oxygenation device with integrated air removal system Download PDF

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Publication number
CN109793956A
CN109793956A CN201811195120.6A CN201811195120A CN109793956A CN 109793956 A CN109793956 A CN 109793956A CN 201811195120 A CN201811195120 A CN 201811195120A CN 109793956 A CN109793956 A CN 109793956A
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CN
China
Prior art keywords
blood
hollow fibers
porous hollow
oxygenator
heat exchanger
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201811195120.6A
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Chinese (zh)
Inventor
S.克尔霍弗
E.佐佐木
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Angiotech Pharmaceuticals Inc
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Angiotech Pharmaceuticals Inc
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Publication of CN109793956A publication Critical patent/CN109793956A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3666Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1621Constructional aspects thereof
    • A61M1/1629Constructional aspects thereof with integral heat exchanger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1698Blood oxygenators with or without heat-exchangers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3623Means for actively controlling temperature of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3643Priming, rinsing before or after use
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24Dialysis ; Membrane extraction
    • B01D61/243Dialysis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24Dialysis ; Membrane extraction
    • B01D61/28Apparatus therefor
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D63/00Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02Hollow fibre modules
    • B01D63/025Bobbin units
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D63/00Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02Hollow fibre modules
    • B01D63/033Specific distribution of fibres within one potting or tube-sheet
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2313/00Details relating to membrane modules or apparatus
    • B01D2313/10Specific supply elements
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2313/00Details relating to membrane modules or apparatus
    • B01D2313/22Cooling or heating elements
    • B01D2313/221Heat exchangers

Abstract

Extracorporeal blood flow circulator can use in medical procedure, such as the open openheart surgery of extracorporal circulatory system.For example, external heat exchange and oxygenation device can be used for promoting surgical operation, such as Coronary Artery Bypass Grafting.In some embodiments, this oxygenation device may include integrated air removal structure.In certain embodiments, air removal structure may include one or more porous hollow fibers.

Description

Extracorporeal oxygenation device with integrated air removal system
Cross reference to related applications
This application claims the equity for the U.S.Provisional Serial 62/572,754 that on October 16th, 2017 submits.Previously The disclosure of application is considered as a part (and being incorporated by reference into) of disclosure of this application.
Technical field
Present document relates to for treating the device used during cardiopathic surgical procedures.For example, present document relates to external Heat exchange and oxygenation device can be used for the open openheart surgery of extracorporal circulatory system to promote by surgical operation, such as coronary artery Road transplantation.Some external heat exchanges described herein and oxygenation device include integrated air removal structure.
Background technique
Using hollow fiber oxygenator to meet gas exchanges of the patient during cardiopulmonary bypass surgery in recycling in vitro Demand.Blood from patient is gravity discharge, or obtains required flow using VAVD (vacuum assisted venous drainage) To keep enough volumes in the reservoir.In the main line of circulation using pump (for example, peristaltic pump or with magnetic drives join The centrifugal pump connect), to pump blood from liquid reservoir, by oxygenator, finally return to patient.
Before starting bypass, by the pumping of crystal preliminary filling solution by extracorporal circulatory system, set with the inside at the position from circulation It ventilates.In some cases, the same amount of air being likely difficult to during preliminary filling in removal oxygenator.
Summary of the invention
This document describes for treating the device used during cardiopathic surgical procedures.For example, this document describes External heat exchange and oxygenation device can be used for the open openheart surgery of extracorporal circulatory system to promote surgical operation, such as coronal dynamic Arteries and veins bypass grafting.Some external heat exchanges described herein and oxygenation device include integrated air removal structure.
In one aspect, the present invention relates to a kind of blood oxygenator equipment comprising blood entry port and blood outlet.Blood Flow path extends to the blood outlet from the blood entry port.The blood oxygenator equipment further includes along the blood The gas exchanging parts of flow path setting;The heat being arranged before the gas exchanging parts along the blood flow paths Switching part;And the one or more Porous hollows being arranged before the heat exchange section along the blood flow paths Fiber.
This blood oxygenator equipment can optionally include one or more of following characteristics.It is one or more of The inside of porous hollow fiber can be connected to the environment space in or around the blood oxygenator equipment.It is one or more The inside of a porous hollow fiber can be connected to vacuum source.The blood oxygenator can also include Flow distributing element, It is arranged before one or more of porous hollow fibers along the blood flow paths.In some embodiments, described One or more porous hollow fibers are wrapped in around the Flow distributing element.One or more of porous hollow fibers can To be wrapped in around the Flow distributing element with right-angled intersection spiral pattern.One or more of porous hollow fibers can be with It is arranged around the Flow distributing element with non-crossing pattern.The hole of one or more of porous hollow fibers allows air Into the inside of one or more of porous hollow fibers, while it is fine to prevent liquid from entering one or more of Porous hollows The inside of dimension.
On the other hand, this disclosure relates to a kind of blood oxygenator equipment comprising: (i) shell limits blood entry port Port and blood exit port mouth;(ii) heat exchanger in the shell is set, and the heat exchanger limits inner space; (iii) the membrane oxygenator part in the shell is set, is arranged in the heat exchanger to the oxygenator partial concentric Around;And one or more porous hollow fibers in the inner space are arranged in (iv).
This blood oxygenator equipment can optionally include one or more of following characteristics.The blood oxygenator Equipment can also include the Flow distributing element being arranged in the inner space.One or more of porous hollow fibers can To be wrapped in around the Flow distributing element.The Flow distributing element is configurable to promote to enter the heat exchanger The substantially homogeneous radial assignment of traffic of blood.It the inside of one or more of porous hollow fibers can be with the blood oxygen Environment space connection in or around clutch equipment.The inside of one or more of porous hollow fibers can connect with vacuum source It is logical.One or more of porous hollow fibers can be arranged with right-angled intersection pattern.One or more of Porous hollows are fine Dimension can be arranged with non-crossing pattern.
On the other hand, this disclosure relates to a kind of method for configuring blood oxygenator equipment.The described method includes: by membrane type Oxygenator is arranged inside the shell, and the shell limits: (i) blood entry port, the outlet of (ii) blood, and (iii) from the blood Entrance extends to the blood flow paths of the blood outlet;Along the blood flow paths before the membrane oxygenator Heat exchanger is set;And one or more Porous hollows are set before the heat exchanger along the blood flow paths Fiber.
This method can optionally include one or more of following characteristics.One or more of Porous hollows are fine Dimension may be arranged such that in or around inside and the blood oxygenator equipment of one or more of porous hollow fibers Environment space connection.The method can also include configuring the oxygenator equipment, by it is one or more of it is porous in Hollow fiber is connected to vacuum source.The method can also include along the blood flow paths one or more of porous Flow distributing element is set before doughnut.One or more of porous hollow fibers can wind in the assignment of traffic Component ambient.One or more of porous hollow fibers can be wrapped in the assignment of traffic member with right-angled intersection spiral pattern Around part.The porous hollow fiber of at least some right-angled intersections can be in fluid communication with each other by the contact between them.Institute Stating one or more porous hollow fibers can be arranged around the Flow distributing element with non-crossing pattern.It is one or The hole of multiple porous hollow fibers allows air into the inside of one or more of porous hollow fibers, while preventing liquid Into the inside of one or more of porous hollow fibers.
The specific embodiment of theme described herein can be implemented to realize one or more of following advantages.One In a little embodiments, using device and method provided herein, patient can be in the feelings with lesser adverse reaction possibility Open-heart surgery is carried out under condition.For example, using some embodiments as described herein, patient will be had less exposure to from body Outer circulation receives a possibility that air embolism.Therefore, the risk of anoxic can be reduced (for example, apoplexy and other kinds of tissue Ischemic).In addition, in some cases, it is possible to reduce clinician spends in the time in preliminary filling extracorporal circulatory system, with ensure can be with Air sufficiently in removal circulation.Therefore, lower-cost surgical operation can be carried out, and clinician's mistake can be reduced Risk.In addition, compared with using the routine in vitro of additional air removal device to recycle, some embodiments as described herein Simplified extracorporal circulatory system is used using permissible.In addition, air removal structure described herein is easy to use low preliminary filling oxygenator Device.Compared with conventional extracorporal circulatory system, this low preliminary filling device can lead to the lower dilution of blood samples of patients.Since blood is dilute Less, a possibility that patient's hematocrit is down to critical value or less reduction is released, therefore patient is less likely to need to transfuse blood.
Unless otherwise defined, otherwise all terms (including technical terms and scientific terms) used herein have and this hair The bright normally understood identical meanings of those of ordinary skill in the art.Although with method those of being described herein and material is similar Or equivalent method and material can be used for implementing the present invention, but this document describes suitable method and materials.The institute being mentioned above There are publication, patent application, patent and other bibliography all to pass through reference to be integrally incorporated.In the case of a conflict, it will control This specification, including definition.In addition, material, method and example are merely illustrative rather than restrictive.
The details of one or more embodiments of the invention is elaborated in the figures and description herein.Other spies of the present invention Sign, objects and advantages will be apparent from specification, drawings and the claims.
Detailed description of the invention
Fig. 1 is that the extracorporal circulatory system heart is carried out while supporting using extracorporal circulatory system according to some embodiments provided herein The schematic diagram of the patient of dirty operation.
Fig. 2 is the signal according to the extracorporeal oxygenation device (and integrated heat exchanger) of some embodiments provided herein Figure.
Fig. 3 schematically depicts the preliminary filling process of the extracorporeal oxygenation device of Fig. 2.
Fig. 4 be according to some embodiments provided herein include integrated air removal structure extracorporeal oxygenation device (and Integrated heat exchanger) schematic diagram.
Fig. 5 schematically depicts the preliminary filling process of the extracorporeal oxygenation device of Fig. 4.
Fig. 6 is the decomposition sectional perspective view of extracorporeal oxygenation device (and integrated heat exchanger).
Fig. 7 be according to some embodiments provided herein include integrated air removal structure extracorporeal oxygenation device (and Integrated heat exchanger) decomposition sectional perspective view.
Fig. 8 be according to some embodiments provided herein include integrated air removal structure extracorporeal oxygenation device (and Integrated heat exchanger) end sections photo.
In the text, identical appended drawing reference represents corresponding part.
Specific embodiment
This document describes for treating the device used during cardiopathic surgical procedures.For example, this document describes External heat exchange and oxygenation device can be used for the open openheart surgery of extracorporal circulatory system to promote surgical operation, such as coronal dynamic Arteries and veins bypass grafting.Some external heat exchanges described herein and oxygenation device include integrated air removal structure.
With reference to Fig. 1, patient 10 can receive therapeutic treatment while using exemplary in vitro blood flow circulation 100. In the illustrated examples, patient 10 is used extracorporeal blood flow circulation 100 and carries out cardiac bypass.Circulation 100 exists Patient 10 is connected at patient's heart 12.Blood from patient 10 extracts at patient's heart 12 from patient 10;Blood circulation Pass through circulation 100;Then blood returns to the heart 12 of patient.
Example extracorporeal blood flow circulation 100 includes at least ductus venosus 110, blood liquid reservoir 120, pump 130, oxygenator 140, arterial filter 150 and arterial duct 160.Ductus venosus 110 and the physical contact of heart 12 and the circulation with patient 10 The vein fluid communication of system.Ductus venosus 110 is also in fluid communication with the entrance of liquid reservoir 120.Going out from liquid reservoir 120 Mouth is connected to the entrance of pump 130 by pipeline.The outlet of pump 130 is connected to the pipeline of the entrance of oxygenator 140.Oxygenator 140 outlet is connected to the entrance of arterial filter 150 by pipeline.The outlet of arterial filter 150 (it is optional) connects It is connected to arterial duct 160.Arterial duct 160 and the physical contact of heart 12 and the artery side liquid with the circulatory system of patient 10 Connection.
In brief, extracorporeal blood flow circulation 100 is grasped by removing venous blood from patient 10 via ductus venosus 110 Make.Hypostasis from ductus venosus 110 is in liquid reservoir 120.In medical procedure, at least a certain amount of blood should be always It is maintained in liquid reservoir 120.Blood from liquid reservoir 120 is extracted out by pump 130 from liquid reservoir 120.The pressure generated by pump 130 It pushes dynamic blood and passes through oxygenator 140.In oxygenator 140, venous blood is rich in oxygen.In addition, in some cases, using simultaneously Enter the heat exchanger in oxygenator 140, increases or decreases to the property of can choose the temperature of blood.Oxygen-enriched arterial blood leaves oxygenator 140, it is advanced through arterial filter 150, and patient's heart 12 is injected by arterial duct 160.
It would be recognized by those skilled in the art that before the use, extracorporeal blood flow circulation 100 is initially included in circulation 100 may be connected to the air that patient 10 must replace before.For the air in replacement cycles 100, the introducing of preliminary filling solution is followed In ring 100.The process is known as preliminary filling circulation 100.
With reference to Fig. 2, the example oxygenator (or referred to as " oxygenator with integrated heat exchanger 200 is schematically depicted 200").Oxygenator 200 includes shell 202.Shell 202 limits ingress port 203i and outlet port 203o.Blood flow paths Outlet port 203o is extended to from ingress port 203i.
Heat exchanger 206 is arranged along blood flow paths.When blood (or preliminary filling solution) is entered by ingress port 203i When shell 202, blood is generally radially flowed towards heat exchanger 206, and continues radially inflow heat exchanger 206.Temperature Water is controlled also by heat exchanger 206, from ingress port 207i to outlet port 207o (or in opposite direction).Work as heat exchanger When 206 permission heats transmit between temperature control water and blood, (multiple) wall of heat exchanger 206 is with the typical way of heat exchanger Temperature control water is physically separate from blood (prevent from mixing).Heat exchanger 206 can be made of metal or polymeric material.Some In embodiment, heat exchanger 206 is made of multiple small pipelines.Inner space 204 is limited by heat exchanger 206.It is handed over reaching heat Before parallel operation 206, the blood of entrance flows through inner space 204.
In some embodiments, Flow distributing element 205 is arranged in inner space 204.Flow distributing element 205 configures For the substantially homogeneous radial flow for promoting blood when blood enters inner space 204 and is changed into heat exchanger 206 Amount distribution.
Oxygenator part 208 (being referred to as " gas exchanging parts ") is along blood flow paths in heat exchanger 206 It is arranged in shell 202 later.In some embodiments, oxygenator part 208 is disposed concentrically upon around heat exchanger 206, is made The blood that heat exchanger 206 must be passed radially through can continue to pass radially through oxygenator part 208.Gas is also by oxygenator part 208, from ingress port 209i to outlet port 209o.Oxygenator part 208 can be made of doughnut (film), allow gas Gas between body and blood shifts (for example, exchange of oxygen and carbon dioxide), while preventing gas and the direct of blood from mixing It closes.
In some embodiments, the end of heat exchanger 206 and/or each tubular element of oxygenator part 208 uses Embedding Material 210 is physically incorporated in together.In some cases, Embedding Material 210 can be polyurethane.By Embedding Material 210 (are in flowable state) be applied to each tubular element of heat exchanger 206 and/or oxygenator part 208 end it Afterwards, Embedding Material 210 is allowed to solidify.In the solid state, Embedding Material 210 (encapsulating heat exchanger 206 and/or oxygenator part 208 Each tubular element end) be sheared.In doing so, exposure heat exchanger 206 and/or oxygenator part 208 it is each The opening of the inside of a tubular element.These openings allow the inside of the tubular element of temperature control water inflow heat exchanger 206, and Gas is allowed to flow into the inside of the tubular element of oxygenator part 208.
After blood flows through oxygenator part 208 (and optional filter medium in some embodiments), it after It is continuous to flow radially outward, until it encounters the wall of shell 202.Then, blood flows out outlet port 203o.It can also include purification Port 211.Purge port 211 can be used for for example allowing air when liquid (for example, preliminary filling solution or blood) enters shell 202 It is left out of shell 202.Hereafter, purge port 211 can be closed.
Fig. 3 shows the preliminary filling process of oxygenator 200.Preliminary filling solution is pumped into shell 202 by ingress port 203i.Preliminary filling Solution enters inner space 204, it can hit Flow distributing element 205 there.Then, preliminary filling solution substantially radially flows Enter heat exchanger 206.Preheated solution substantially radially flows into oxygenator part 208 from heat exchanger 206.Passing through oxygenator portion Divide after 208, preliminary filling solution fills the remaining space in shell 202, then leaves oxygenator 200 by outlet port 203o.
When preliminary filling solution flows in the above described manner, the air in shell 202 is by preliminary filling solution replacement.It can permit at least Some air being replaced leave shell by purge port 211.When preliminary filling solution, which begins through purge port 211, to be occurred, Purge port 211 can be closed.At this point, clinician can correctly assume most of air previously in shell 202 It is eliminated.That is, there will still likely be some minute bubbles or air bag in shell 202.
In some cases, minute bubbles 212 at least can initially tend to remain in the entrance of heat exchanger 206.Such as Fruit allows preliminary filling solution to continue to flow, then over time, become, most or all of minute bubbles 212 can finally flow out shell 202.However, in some cases, some minute bubbles 212 may retain or clinician may be preferably not pre- for a long time Being filled with makes all minute bubbles 212 flow out shell 202.
With reference to Fig. 4, the example oxygenator (or referred to as " oxygenator with integrated heat exchanger 220 is schematically depicted 220").Oxygenator 220 includes shell 222.Shell 222 limits ingress port 223i and outlet port 223o.Blood flow paths Outlet port 223o is extended to from ingress port 223i.
Heat exchanger 226 is arranged along blood flow paths.When blood (or preliminary filling solution) is entered by ingress port 223i When shell 222, blood is generally radially flowed towards heat exchanger 226, and continues radially inflow heat exchanger 226.Temperature Water is controlled also by heat exchanger 226, from ingress port 227i to outlet port 227o.When heat exchanger 226 allows heat in temperature Between control water and blood when transmitting, (multiple) wall of heat exchanger 226 is with the typical way of heat exchanger by temperature control water and blood It is physically separate from (prevent from mixing).Heat exchanger 226 can be made of metal and/or polymeric material.In some embodiments, hot Exchanger 226 is made of multiple small pipelines.Inner space 224 is limited by heat exchanger 226.Before reaching heat exchanger 226, The blood of entrance flows through inner space 224.
In some embodiments, for example, shown in embodiment, Flow distributing element 225 be arranged in inner space 224.Stream Amount distribution member 225 is configured to promote blood when blood enters inner space 224 and is changed into heat exchanger 226 Substantially homogeneous radial direction assignment of traffic.
Oxygenator part 228 (being referred to as " gas exchanging parts ") is along blood flow paths in heat exchanger 226 It is arranged in shell 222 later.In some embodiments, oxygenator part 228 is disposed concentrically upon around heat exchanger 226, is made The blood that heat exchanger 226 must be passed radially through can continue to pass radially through oxygenator part 228.Gas is also by oxygenator part 228, from ingress port 229i to outlet port 229o.Oxygenator part 228 can be made of doughnut (film), allow gas Gas between body and blood shifts (for example, exchange of oxygen and carbon dioxide), while preventing gas and the direct of blood from mixing It closes.
As described in above with reference to oxygenator 200, each tubular element of heat exchanger 226 and/or oxygenator part 228 End is physically incorporated in together using Embedding Material 230.It can also include purge port 231.In some embodiments, optional Arterial filter medium be also included in oxygenator 220.
In addition, oxygenator 220 includes one or more porous hollow fibers 232.In an illustrated embodiment, one or more A porous hollow fiber 232 is arranged in inner space 224 before heat exchanger 226 along blood flow paths.Some In embodiment, one or more porous hollow fibers 232 are arranged in the inside of heat exchanger 226.That is, in some realities It applies in example, one or more porous hollow fibers 232 are scattered with (a variety of) physical material of heat exchanger 226 (for example, pipeline Deng).In certain embodiments, one or more porous hollow fibers 232 along blood flow paths heat exchanger 226 it It is preceding to be arranged in inner space 224 and be arranged in the inside of heat exchanger 226.
In some embodiments, one or more porous hollow fibers 232 are made of polypropylene fibre.Specifically implementing In example, the diameter of one or more porous hollow fibers 232 can be about 170 μm, or about 300 μm or any other suitable ruler It is very little.One or more porous hollow fibers 232 have hole, and size allows air into one or more porous hollow fibers 232 inside, while preventing liquid from entering the inside of one or more porous hollow fibers 232.Therefore, one or more porous Doughnut 232 can help to remove air out of inner space 224.The hydrostatic pressure and dynamic of preliminary filling solution (or blood) are pressed Power (from flowing momentum) can provide the driving force that air enters one or more porous hollow fibers 232.
One or more porous hollow fibers 232 have the free end 232e as open end.In an illustrated embodiment, Free end 232e is located in the environment space in or around blood oxygenator 220.Therefore, one or more porous hollow fibers Environment space in or around 232 inside and blood oxygenator equipment 220 is in fluid communication.That is, into one or more The air of a porous hollow fiber 232 can leave from free end 232e, the environment in or around blood oxygenator equipment 220 Space.In some embodiments, free end 232e is positioned to lead to identical space with oxygenator part 228.That is, into The air for entering one or more porous hollow fibers 232 can leave from free end 232e, arrive identical with oxygenator part 228 Space, and oxygenator 220 is left from gas vent port 229o.
In some embodiments, free end 232e is connected to vacuum source (not shown).Therefore, the use of vacuum source can be led Cause bigger pressure difference (driving force) in order to removed in a manner of enhancing air (with it is simply that one or more Porous hollows are fine Dimension 232 is led to ambient air and is compared).
It in some embodiments, can be (at least partly) fine by one or more Porous hollows using Embedding Material 230 Dimension 232 is physically integrated to the other parts of oxygenator 220.In an illustrated embodiment, with heat exchanger 226 and oxygenator portion Points 228 different, the ends of one or more porous hollow fibers 232 will not by the shearing of Embedding Material 230 exposure (because Free end 232e has been exposed to ambiance).Alternatively or additionally, in some embodiments, the end of one or more parts Portion (or fully) exposed due to shearing or otherwise removing some Embedding Materials 230.
Fig. 5 shows the preliminary filling process of oxygenator 220.Preliminary filling solution is pumped into shell 222 by ingress port 223i.Preliminary filling Solution enters inner space 224, it can hit Flow distributing element 225 there.Then, preliminary filling solution substantially radially flows Enter heat exchanger 226.Preheated solution substantially radially flows into oxygenator part 228 from heat exchanger 226.Passing through oxygenator portion Divide after 228, preliminary filling solution fills the remaining space in shell 222, then leaves oxygenator 220 by outlet port 223o.
When preliminary filling solution flows in the above described manner, the air in shell 222 is by preliminary filling solution replacement.It can permit at least Some air being replaced leave shell by purge port 231.When preliminary filling solution, which begins through purge port 231, to be occurred, Purge port 231 can be closed.At this point, clinician can correctly assume most of air previously in shell 222 It is eliminated.That is, there will still likely be some minute bubbles or air bag in shell 222.
In an illustrated embodiment, oxygenator 220 includes one or more porous hollow fibers 232.Therefore, if shell There are still some minute bubbles or air bags in 222, then air will tend to enter one or more porous hollow fibers 232.? Into after one or more porous hollow fibers 232, air will flow out one or more Porous hollows via free end 232e Fiber 232, and enter the environment space in or around blood oxygenator equipment 220.In this way, during preliminary filling process, One or more porous hollow fibers 232 accelerate the removal of the air in oxidator 220.In addition, if using oxygenator It is carried secretly during 220 medical procedure, in blood circulation or starts to carry air secretly, then one or more porous hollow fibers 232 can It is used to help remove this air.
With reference to Fig. 6, show example oxygenator 240 to decompose sectional perspective view (including integrated heat exchanger).Oxygen closes Device 240 includes the blood entry port 242 extended from end wall 243, and the blood outlet 244 extended from peripheral shell 245.Work as blood When flowing between blood entry port 242 and blood outlet 244, blood passes through heat exchanger 248 and oxygenator fibre bundle 250.? In some embodiments, one or more filters component also may include in the blood flow paths in oxygenator module 240. Heat exchanger 248 limits inner space 241.
In some embodiments, optional Flow distributing element 249 may include in oxygenator module 240.Work as blood When being transmitted to heat exchanger 248 from inner space 241, Flow distributing element 249 can promote the desired flow distribution (example of blood It such as, is in some embodiments substantially homogeneous radial assignment of traffic).
Oxygenator 240 further includes the first water end (W.E.) mouth 246a and the second water end (W.E.) mouth 246b.Water end (W.E.) mouth 246a and 246b allow water Flow in and out, via heat exchanger 248 is cooling or heating blood.Oxygenator 240 further includes gas access (invisible) With gas vent 252.Gas access and outlet 252 allow flowing in and out for oxygen rich gas, via oxygenator fibre bundle 250 Give blood oxygenating.Oxygenator 240 includes two end caps 247a and 247b, is facilitated oxygenator module 240 in structure Component keeps together, and limits the annular manifold for being used for water and oxygen rich gas.Oxygenator 240 further includes other component, example Such as purge port 254 and other various parts well known by persons skilled in the art and feature.
In an illustrated embodiment, oxygenator 240 further includes that (it is referred to as " heat to optional Flow distributing element 260 Exchanger ontology "), it is arranged in inner space 241.Therefore, Flow distributing element 260 can promote to flow into inner space 241 blood, thus hereafter with the flowing of substantially homogeneous Radial Flow mode.Flow distributing element 260 can have frustum of a cone Shape.In some embodiments, Flow distributing element 260 includes one or more ribs 262.Rib 262 can be shaped and is oriented in On the outer surface of the other parts of Flow distributing element 260, the blood for allowing flow into inner space 241 is substantially filled with internal sky Between 241, then with substantially homogeneous Radial Flow mode flowing.
With reference to Fig. 7, in some embodiments, oxygenator 240 further includes one or more porous hollow fibers 270.As above For text with reference to described in oxygenator 220, one or more porous hollow fibers 270 can be relative to the other parts cloth of oxygenator 240 It sets in oxygenator 240.
In an illustrated embodiment, one or more porous hollow fibers 270 are wrapped in around Flow distributing element 260. Particularly, in an illustrated embodiment, one or more porous hollow fibers 270 are wrapped in assignment of traffic with right-angled intersection pattern Around element 260.Such right-angled intersection pattern can be spiral pattern.In some embodiments, and inside end sections The winding density of one or more porous hollow fibers 270 is compared, at the end sections that can increase Flow distributing element 260 The winding density of one or more porous hollow fibers 270.Any suitable winding pattern can be used (for example, pitch, angle Degree winds quantity, the interval, etc. between winding).Any amount of long filament (individual doughnut) can be used.Such as It but is not limitation, in some cases it may long using a root long silk, two root long silks, four root long silks, eight root long silks, ten six roots of sensation Silk, 32 root long silks (or any other appropriate number of long filament) (and being wound with required pattern).
It, in some cases can be advantageous when using right-angled intersection pattern (for example, as illustrated in fig. 7 rather than limit) Ground generates the intersection connection between the long filament of one or more porous hollow fibers 270.That is, the crosspoint of microporous fibre Gas connection bridge can be formed, can permit gas (for example, air) not only along the longitudinal direction and radially of fiber Direction (between adjacent fiber) transmitting.This connection is for leading to one or more porous hollow fibers 270 from blood path Atmosphere is highly useful.As the substitution needed from all fibres of 240 pass-out of oxygenator, can be used one for reducing quantity or Multiple porous hollow fibers 270 are discharged the air of capture.In some cases, this attribute may also help in realization and can manufacture Property.
In some embodiments, one or more porous hollow fibers 270 can be arranged with non-crossing pattern in oxygenator In 240.In some such embodiments, the longitudinal axis of one or more porous hollow fibers 270 can be parallel to oxygen conjunction The central longitudinal axis of device 240.In some such embodiments, the longitudinal axis of one or more porous hollow fibers 270 Can relative to oxygenator 240 central longitudinal axis with non-zero angle orientation (for example, between about 0 ° -10 °, or about 5 ° - Between 15 °, or between about 10 ° -20 °, or between about 15 ° -25 °, or between about 20 ° -30 °, etc.).In some implementations In example, one or more porous hollow fibers 270 can be hollow fiber mat.One or more layers this hollow fibre can be used Dimension pad.
In some embodiments, one or more porous hollow fibers 270 can be used for gas transfer purpose, such as but not It is limited to blood oxygenation and/or removes carbon dioxide from blood.
Fig. 8 is the extracorporeal oxygenation device 300 including integrated air removal structure according to some embodiments provided herein The photo of the end sections of (and integrated heat exchanger).The end cap of oxygenator 300 is not included in photo, preferably may be used Depending on change oxidator 300 with lower component.
Oxygenator 300 includes that oxygenator part 310, heat exchanger 320, Flow distributing element 330 and one or more are more Hole doughnut 340.In an illustrated embodiment, recess 332 includes in the end of Flow distributing element 330.In some realities Apply in example, (for example, machining) recess 332 generated after dosing technology so as to generate it is one or more it is porous in The open end of hollow fiber 340, to allow air to lead to atmosphere from one or more porous hollow fibers 340.
Although this specification includes many specific embodiment details, these are not construed as to any hair It is bright or can be with the limitation of claimed range, but the description of the feature as the specific embodiment for being directed to specific invention. Certain features described in the context of separate embodiments can also be combined or be realized in a single embodiment in this specification. On the contrary, the various features described in the context of single embodiment can also be in various embodiments individually or with any conjunction Suitable sub-portfolio is realized.In addition, although feature can be described herein as with it is certain combination work and even initially such as This advocates, but can delete from the combination in some cases from combined one or more features claimed It removes, and combination claimed can be related to the modification of sub-portfolio or sub-portfolio.
Similarly, although describing operation in the accompanying drawings with particular order, this is understood not to require shown in Particular order or sequencing execute such operation, or execute all operations shown to realize desired result.At certain In a little situations, multitask and parallel processing be may be advantageous.In addition, various system modules in embodiment as described herein and The separation of component is not construed as requiring this separation in all of the embodiments illustrated, and it should be understood that described Program assembly and system usually can be integrated in together in single product or be packaged into multiple products.
The specific embodiment of theme has been described.Other embodiments are in the range of following claims.For example, right The movement recorded in it is required that can be executed in different order and still realize desired result.As an example, attached drawing The process of middle description be not necessarily required to shown in particular order or sequencing, to realize desired result.In certain embodiment party In formula, multitask and parallel processing be may be advantageous.

Claims (20)

1. a kind of blood oxygenator equipment, comprising:
Blood entry port and blood outlet, extend to the blood flow paths that the blood exports from the blood entry port;
The gas exchanging parts being arranged along the blood flow paths;
The heat exchange section being arranged before the gas exchanging parts along the blood flow paths;And
The one or more porous hollow fibers being arranged before the heat exchange section along the blood flow paths.
2. blood oxygenator equipment as described in claim 1, wherein the inside of one or more of porous hollow fibers with Environment space connection in or around the blood oxygenator equipment.
3. blood oxygenator equipment as described in claim 1, wherein the inside of one or more of porous hollow fibers with The vacuum source connection.
4. blood oxygenator equipment as described in claim 1, further includes Flow distributing element, along the blood flow road Diameter is arranged before one or more of porous hollow fibers.
5. blood oxygenator equipment as claimed in claim 4, wherein one or more of porous hollow fibers are wrapped in institute It states around Flow distributing element.
6. blood oxygenator equipment as claimed in claim 5, wherein one or more of porous hollow fibers are handed over cross Fork spiral pattern is wrapped in around the Flow distributing element.
7. blood oxygenator equipment as claimed in claim 4, wherein one or more of porous hollow fibers are with non-crossing Pattern is arranged around the Flow distributing element.
8. blood oxygenator equipment as described in claim 1, wherein the hole of one or more of porous hollow fibers allows Air enter one or more of porous hollow fibers inside, while prevent liquid enter it is one or more of it is porous in The inside of hollow fiber.
9. a kind of blood oxygenator equipment, comprising:
Shell limits blood inlet port and blood exit port mouth;
Heat exchanger in the shell is set, and the heat exchanger limits inner space;
Membrane oxygenator part in the shell is set, and the oxygenator part surrounds the heat exchanger concentrically cloth It sets;And
One or more porous hollow fibers in the inner space are set.
10. blood oxygenator equipment as claimed in claim 9 further includes the assignment of traffic member being arranged in the inner space Part.
11. blood oxygenator equipment as claimed in claim 10, wherein one or more of porous hollow fibers are wrapped in Around the Flow distributing element.
12. blood oxygenator equipment as claimed in claim 11, wherein the Flow distributing element is configured to promote to enter institute State the substantially homogeneous radial assignment of traffic of the blood of heat exchanger.
13. blood oxygenator equipment as claimed in claim 9, wherein the inside of one or more of porous hollow fibers with Environment space connection in or around the blood oxygenator equipment.
14. blood oxygenator equipment as claimed in claim 9, wherein the inside of one or more of porous hollow fibers with Vacuum source connection.
15. blood oxygenator equipment as claimed in claim 9, wherein one or more of porous hollow fibers are handed over cross Pitch pattern arrangement.
16. blood oxygenator equipment as claimed in claim 9, wherein one or more of porous hollow fibers are with non-crossing Pattern arrangement.
17. a kind of method for configuring blood oxygenator equipment, which comprises
Inside the shell by membrane oxygenator setting, the shell limits: (i) blood entry port, the outlet of (ii) blood, and (iii) The blood flow paths that the blood exports are extended to from the blood entry port;
Heat exchanger is set before the membrane oxygenator along the blood flow paths;And
One or more porous hollow fibers are set before the heat exchanger along the blood flow paths.
18. method as claimed in claim 17, wherein one or more of porous hollow fibers are arranged so that described one The inside of a or multiple porous hollow fibers is connected to the environment space in or around the blood oxygenator equipment.
19. method as claimed in claim 17, also along the blood flow paths in one or more of Porous hollows Blood flow distribution member is set before fiber, and wherein one or more of porous hollow fibers are wrapped in the flow point With component ambient.
20. method as claimed in claim 17, wherein the hole of one or more of porous hollow fibers allows air into The inside of one or more of porous hollow fibers, while preventing liquid from entering one or more of porous hollow fibers It is internal.
CN201811195120.6A 2017-10-16 2018-10-15 Extracorporeal oxygenation device with integrated air removal system Pending CN109793956A (en)

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JP2019072489A (en) 2019-05-16

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