CN109793956A - Extracorporeal oxygenation device with integrated air removal system - Google Patents
Extracorporeal oxygenation device with integrated air removal system Download PDFInfo
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- 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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- blood
- hollow fibers
- porous hollow
- oxygenator
- heat exchanger
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- 239000012510 hollow fiber Substances 0.000 claims abstract description 85
- 230000017531 blood circulation Effects 0.000 claims abstract description 37
- 238000000034 method Methods 0.000 claims abstract description 20
- 239000008280 blood Substances 0.000 claims description 110
- 210000004369 blood Anatomy 0.000 claims description 110
- 239000007788 liquid Substances 0.000 claims description 15
- 239000000835 fiber Substances 0.000 claims description 11
- 239000012528 membrane Substances 0.000 claims description 6
- 238000009826 distribution Methods 0.000 claims description 4
- 239000004744 fabric Substances 0.000 claims description 2
- 238000001356 surgical procedure Methods 0.000 abstract description 9
- 210000004351 coronary vessel Anatomy 0.000 abstract description 2
- 230000001737 promoting effect Effects 0.000 abstract description 2
- 239000003570 air Substances 0.000 description 40
- 239000007789 gas Substances 0.000 description 23
- 239000000243 solution Substances 0.000 description 23
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- 230000004087 circulation Effects 0.000 description 14
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- 238000010926 purge Methods 0.000 description 10
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- 229910052760 oxygen Inorganic materials 0.000 description 9
- 239000001301 oxygen Substances 0.000 description 9
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 6
- 235000012489 doughnuts Nutrition 0.000 description 6
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- 230000003130 cardiopathic effect Effects 0.000 description 3
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- 230000000747 cardiac effect Effects 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
- A61M1/1629—Constructional aspects thereof with integral heat exchanger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1698—Blood oxygenators with or without heat-exchangers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3623—Means for actively controlling temperature of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3643—Priming, rinsing before or after use
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/24—Dialysis ; Membrane extraction
- B01D61/243—Dialysis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/24—Dialysis ; Membrane extraction
- B01D61/28—Apparatus therefor
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
- B01D63/02—Hollow fibre modules
- B01D63/025—Bobbin units
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
- B01D63/02—Hollow fibre modules
- B01D63/033—Specific distribution of fibres within one potting or tube-sheet
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/10—Specific supply elements
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/22—Cooling or heating elements
- B01D2313/221—Heat 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
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.
Applications Claiming Priority (2)
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US201762572754P | 2017-10-16 | 2017-10-16 | |
US62/572,754 | 2017-10-16 |
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CN201811195120.6A Pending CN109793956A (en) | 2017-10-16 | 2018-10-15 | Extracorporeal oxygenation device with integrated air removal system |
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JP (1) | JP2019072489A (en) |
CN (1) | CN109793956A (en) |
DE (1) | DE102018217584A1 (en) |
FR (1) | FR3072293A1 (en) |
GB (1) | GB2568813B (en) |
Cited By (1)
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CN117599274A (en) * | 2024-01-05 | 2024-02-27 | 江苏赛腾医疗科技有限公司 | Membrane oxygenator |
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EP3782671B1 (en) * | 2019-08-19 | 2021-07-07 | Gambro Lundia AB | Method for priming an extracorporeal blood circuit of an apparatus for extracorporeal treatment of blood and apparatus for extracorporeal treatment of blood |
DE102020104117A1 (en) * | 2020-02-18 | 2021-08-19 | Universität des Saarlandes | Device for removing a gas from an aqueous liquid |
DE102021100091B4 (en) | 2020-05-13 | 2022-07-14 | Drägerwerk AG & Co. KGaA | System for supplying gases for ventilation and oxygenation with supply of inhalable substances |
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Also Published As
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DE102018217584A1 (en) | 2019-04-18 |
GB2568813B (en) | 2022-04-13 |
GB2568813A (en) | 2019-05-29 |
FR3072293A1 (en) | 2019-04-19 |
JP2019072489A (en) | 2019-05-16 |
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