CN101262931A - Paracorporeal respiratory assist lung - Google Patents
Paracorporeal respiratory assist lung Download PDFInfo
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- CN101262931A CN101262931A CNA2006800197916A CN200680019791A CN101262931A CN 101262931 A CN101262931 A CN 101262931A CN A2006800197916 A CNA2006800197916 A CN A2006800197916A CN 200680019791 A CN200680019791 A CN 200680019791A CN 101262931 A CN101262931 A CN 101262931A
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Abstract
A paracorporeal respiratory assist lung is configured with an annular cylindrical hollow fiber membrane (fiber bundle) that is rotated at rapidly varying speeds. Fluid (for example, blood) is introduced to the center of the device and is passed radially through the fiber bundle. The bundle is rotated at rapidly changing velocities with a rotational actuator (for example, a motor or magnetic coupling). The rotation of the fiber bundle provides centrifugal kinetic energy to the fluid giving the device pumping capabilities and may create Taylor vortexes to increase mass transfer. Rotation of the fiber bundle increases the relative velocity between the fluid and the hollow fibers and increases the mass transfer. The porosity of the fiber bundle may be varied to enhance gas exchange with the blood. Alternatively, a rotating core may be used with a stationary fiber bundle.
Description
The research that federal government subsidizes
[0001] the fund RO1 HL 70051 that authorizes in view of the fund DAMD 17-02-1-0717 that provides war department (the Department ofthe Army) to authorize and American National health association (the NationalInstitutes of Health), U.S. government has the permission of paying off whole funds to the present invention, and the requirement title to patent that has the right under condition of limited permits other people to implement with rational clause.
The cross reference of related application
[0002] the application requires the 60/673rd, No. 885 U.S. Provisional Application of submitting on April 21st, 2005 and the 60/688th, No. 809 U.S. Provisional Application No. of submitting on June 8th, 2005, is incorporated herein it all as a reference.
Background technology
[0003] the present invention relates to improved vein-vein extracorporal circulatory system oxygenator, this paper is called as " Paracorporeal respiratory assist lung (paracorporeal respiratory assist lung) " or " PRAL device ".More particularly, Paracorporeal respiratory assist lung comprises (vibration) rotation fibre bundle of variable-ratio, and it has the gas porosity of raising.In addition, the PRAL device can be designed to make the core rotation, and wherein said fibre bundle is static, and can further be designed to be included in the fibre bundle on the described rotation core.
[0004] it is reported, have 350 every year, 000 American dies from lung cancer, and major part is because acute respiratory distress syndrome (Acute Respiratory Destress Syndrome (ARDS)) and COPD (Chronic Obstructive Pulmonary Disease (COPD)).Modal methods of treatment is force ventilation, but can further increase the weight of respiratory insufficiency and may cause serious adverse, for example barotrauma (barotrauma) and capacity damage (volutrauma).According to further, at intra-operative, the heart-lung machine, it uses oxygenator, and be used hundreds thousand of every year in the whole world.Such oxygenator can be used to treat COPD and ARDS.Yet, the material Transfer (gas exchange) that a FAQs that is used in the oxygenator in the heart-lung machine is oxygen and carbon dioxide poor efficiency.
[0005] giving the use of the membrane oxygenator of blood oxygenation is known in this area.A kind of traditional membrane oxygenator has used hollow fiber bundle, and it is retained in the columniform shell, and wherein oxygen is to be pumped to by described doughnut with the direction identical with blood.This doughnut is made up of microporous barrier, and it does not have permeability and gas is had permeability blood.When venous blood flow through this shell and contacts with this doughnut, the gas exchange took place.According to diffusion law, oxygen diffuses through hollow fiber walls, and makes the venous blood that contacts with these doughnuts be rich in oxygen.The shortcoming of such membrane oxygenator is to form blood boundary layer around doughnut, and this has delayed the oxygenation to the blood that does not have directly to contact with described doughnut.
[0006] membrane oxygenator of another kind of known type comprises a part of mobile oxygenator, mixes with the enhancing that blood flow is provided.In this type of membrane oxygenator, blood circulation path and Oxygen Flow path are positioned between rotor and the stator, and are separated by film and partition and come.When rotor rotated with respect to stator, the mixing of blood flow took place, and this just causes having broken blood boundary layer.The oxygenator of even now makes blood have mixing to a certain degree, but this mixing may cause erythrocytic destruction.In an embodiment of such oxygenator, oxygenous cylindrical semi-permeable film is rotated in shell, makes blood contact and flow through this film, and oxygen is transferred in this blood by this rotation film.The problem that this membrane oxygenator is in the news is the permeability of semipermeable membrane to oxygen and carbon dioxide difference.
[0007] also have another kind of known membrane oxygenator to comprise a plurality of hollow-fibre membranes of longitudinal extension basically, first inert fiber is spaced apart and also be longitudinal extension basically between them.Second inert fiber generally laterally extends and generally extends near it to described doughnut, so oxygenous gas can pass described doughnut, and blood can flow through its outside and carries out the gas exchange to see through this film.Second inert fiber can form parallel, and first inert fiber puts one with being spaced apart between per two doughnuts, so this warp is alternately fibrous by the doughnut that passes parallel in the swing mode and first inert fiber.This inert fiber is disclosed as the monofilament polymer of biocompatibility, and it provides the interval of doughnut, even has produced the blood film.Yet such oxygenator is not designed to external, and it has low relatively velocity of blood flow.
[0008] therefore, external oxygenator with air exchange property of enhancing be need and be unavailable up to now, the enhancing of air exchange property is because the rotation fibre bundle of variable-ratio and/or the raising of this fiber bundle porosity, it has high gas exchange efficiency, and to the damage minimum of blood constituent.
Summary of the invention
[0009] the present invention relates to improved vein-vein extracorporal circulatory system oxygenator, this paper is called as " Paracorporeal respiratory assist lung (paracorporeal respiratory assist lung) ".This vein-vein artificial lung can replace the force ventilation therapy and be used to COPD (ChronicObstructive Pulmonary Disease (COPD)) patient, contains high-caliber partial pressure of carbon dioxide (pCO in their blood
2).The rotation of the assembly of Paracorporeal respiratory assist lung of the present invention by containing gas permeability doughnut (circular fiber bundle) provides positive mixing, makes to have improved the gas exchange in the blood constant speed under by this device.Learn that the rotation of this fibre bundle has strengthened the gas exchange efficiency of artificial lung, for example carbon dioxide (CO
2) transmission efficiency increased by 200% (200 percentage points).Verified, velocity of blood flow is in the scope of per minute 0.5 to 1.0 liter (l/min) time, CO
2Removal can reach per minute 100-120 milliliter (ml/min).This rotation fibre bundle provides blood flow to cross the effect of taking out certainly that pressure head is lower than the device of 30 millimetress of mercury (mmHg).Verified, by changing the diameter or the rotary speed of circular fiber bundle, can adjust the effect of taking out certainly that blood flow is crossed the device of band pressure head, wherein can be adjusted to be fit to this application from the effect of taking out.The prototype of fiber bundle diameters up to 4 inches produced the pressure head up to 100-300mmHg.Therefore, Paracorporeal respiratory assist lung has served as the integrated mass transfer device of pump/hollow-fibre membrane.
[0010] according to the present invention, be to comprise ring-shaped cylinder shape hollow-fibre membrane device to the improved one side of Paracorporeal respiratory assist lung, this device is rotated with rapid variable speed.Fluid is imported into this device center and radial flow is crossed this fibre bundle.Under revolving actuator (being generally motor) effect, this fibre bundle is rotated with vertiginous speed.Verified, when the rotary speed of this fibre bundle was changed rapidly, the present invention had improved material Transfer.For instance, will vibrate or swing (oscillations) and be incorporated in the stable state rotation of hollow fiber bundle, improved the substance transfer efficient of this device, kept its pumpage (pumpingcapabilities) simultaneously.
[0011] according to the present invention, improved to Paracorporeal respiratory assist lung is to comprise having increased the gas porosity of this rotation fibre bundle (porosity) on the other hand.The gas porosity of this increase provides more fluid to flow through this fibre bundle, has therefore increased the mass transfer efficiency of this device integral body.The extra gas porosity of this fibre bundle is to produce by several possible approach, includes but not limited to, uses spacer to produce the space between fibrage, removes one every a fiber in this mat of fibers, and uses the more fiber of minor diameter.In addition, Support Level also can be removed from fabric, and Paracorporeal respiratory assist lung can be designed, so that header is nearer relatively, so that this fibre bundle " fluffy (puff out) ".
[0012] the further aspect of the present invention comprises Paracorporeal respiratory assist lung, and it has following feature:
● have external vein-vein system through the leather sheath pipe
● be inserted in the venous circulation of blood flow
● the blood flow that drives by the rotation fibre bundle from swabbing action
● before blood arrives lung, remove CO
2And supply O
2
● under VPV is lower than one liter of per minute, carry out the gas exchange
● make the hollow fiber bundle rotation to strengthen the gas exchange
● the rotary annular fibre bundle impels the flow velocity through fiber surface to increase
● static core and shell produce fluid shearing on fibre bundle
● blood path allows the rotation bundle to extract fluid out
● closely effective hollow-fiber module is from outside deterioration
[0013] Paracorporeal respiratory assist lung additional features of the present invention comprises:
● variable rotation has strengthened the gas exchange
● the gas porosity of this fibre bundle is variable
● blood flow is at 500-700mL/min for keeping breathing
● little two lumen cannula (14-16French (french scale))
● the active surface area of this fibre bundle is less than 0.50 square metre of (m
2)
● VPV when 0.5 to 1.0 liter of per minute, CO
2Removal be 100-120ml/min
● CO
2Removal do not rely on the functional capacity of natural lung
[0014] an embodiment of the invention comprise Paracorporeal respiratory assist lung, and it has the shell that contains fluid intake, fluid issuing, gas access and gas vent.This PRAL device comprises a plurality of tubular gas permeability tunica fibrosas, it is configured to the formation fibre bundle, this fibre bundle is placed in the shell, and links to each other with gas vent with the gas access and carry out fluid communication, and wherein first gap design is between this shell and this fibre bundle.This device further comprises static core, and it is placed in this fibre bundle, and wherein second gap is designed between this core and this fibre bundle.This PRAL device can be designed to make this fibre bundle rotation, and wherein this shell, fibre bundle and core are designed such that the fluid that enters fluid intake flows through fibre bundle and enters this fluid issuing.
[0015] the optional embodiment of Paracorporeal respiratory assist lung of the present invention comprises the shell that contains fluid intake, fluid issuing, gas access and gas vent.This PRAL device comprises a plurality of tubular gas permeability tunica fibrosas, it is configured to the formation fibre bundle, this fibre bundle is placed in the shell, and links to each other with gas vent with the gas access and carry out fluid communication, and wherein first gap design is between this shell and this fibre bundle.This device is designed to have the core that is placed in this fibre bundle, and wherein second gap is designed between this core and this fibre bundle.This device can comprise the mechanism that makes this core rotation, and wherein this shell, fibre bundle and core are designed such that the fluid that enters fluid intake flows through fibre bundle and enters this fluid issuing.This PRAL device can further be designed, and produces a plurality of Taylor vortexs (Taylor vortex) with turbulization in second gap and in second gap.In addition, this fibre bundle is designed to have gas porosity, and it allows fluid evenly to flow through this fibre bundle.Further, this PRAL device can be designed, thereby first gap and second gap are designed such that the fluid that passes this fibre bundle flows and are optimized.
[0016] from following detailed and accompanying drawing, other features and advantages of the present invention will become obviously, and it has illustrated feature of the present invention for example.
Description of drawings
[0017] Fig. 1 has described arranging at body of Paracorporeal respiratory assist lung of the present invention.
[0018] Fig. 2 A-2C describes several views of an embodiment of Paracorporeal respiratory assist lung of the present invention.
[0019] Fig. 3 A-3D describes several views of the optional embodiment of Paracorporeal respiratory assist lung of the present invention.
[0020] Fig. 4 A and 4B are the schematic diagrames of Paracorporeal respiratory assist lung of the present invention, and it has shown the rotation bundle.
[0021] Fig. 5 A-5P describes several views of the optional embodiment of Paracorporeal respiratory assist lung of the present invention.
[0022] Fig. 6 describes the optional embodiment of Paracorporeal respiratory assist lung of the present invention.
[0023] Fig. 7 describes the optional embodiment of Paracorporeal respiratory assist lung of the present invention.
[0024] Fig. 8 A-8D describes several views of the optional embodiment of Paracorporeal respiratory assist lung of the present invention.
[0025] Fig. 9 show the optional embodiment of Paracorporeal respiratory assist lung of the present invention schematic diagram, it has magnetically-actuated mechanism.
[0026] Figure 10 A and 10B describe the optional embodiment of Paracorporeal respiratory assist lung of the present invention.
[0027] Figure 11 is the cross-sectional view of Paracorporeal respiratory assist lung shown in Figure 10.
[0028] Figure 12 A and 12B are the schematic diagrames of Paracorporeal respiratory assist lung shown in Figure 11.
[0029] Figure 13 shows the schematic diagram of the optional embodiment of Paracorporeal respiratory assist lung of the present invention.
[0030] Figure 14 is the block diagram of system of the present invention.
[0031] Figure 15 shows the cross-sectional view of the optional embodiment of Paracorporeal respiratory assist lung of the present invention, and it has magnetically-actuated mechanism.
[0032] Figure 16 A and 16B are according to cage of the present invention mechanism, are suitable for using described fibre bundle.
[0033] Figure 17 A, 17B show to have fiber mat schematic diagram at interval, and it is used for Paracorporeal respiratory assist lung of the present invention.
[0034] Figure 18 is the described block diagram of system according to the present invention.
[0035] Figure 19 is the described block diagram of system according to the present invention.
[0036] Figure 20 is the diagram of a gas exchange rate that embodiment reached of Paracorporeal respiratory assist lung of the present invention.
[0037] Figure 21 is the diagram of a gas exchange rate that embodiment reached of Paracorporeal respiratory assist lung of the present invention.
[0038] Figure 22 is the diagram of the blood flow that embodiment reached (suction capactity) of Paracorporeal respiratory assist lung of the present invention.
[0039] Figure 23 is based on the model prediction diagram of fiber bundle porosity.
[0040] Figure 24 and 25 is that the variable carbon dioxide that gas porosity reached of this fibre bundle is removed and the diagram of blood flow (pumpage) in the Paracorporeal respiratory assist lung of the present invention.
[0041] Figure 26 is the diagram of the flow model (FEMLAB) by this fibre bundle.
The specific embodiment
[0042] the present invention relates to improved vein-vein extracorporal circulatory system oxygenator, this paper is called as " Paracorporeal respiratory assist lung (paracorporeal respiratory assist lung) " or " PRAL device ".Paracorporeal respiratory assist lung of the present invention comprises the hollow fiber membrane bundle of rotation, and it crosses the gas exchange efficiency that the caused boundary layer phenomenon of this fiber has increased this device by reducing blood flow.U.S. Patent number 5,830,370 (Maloney etc.), 5,900,142 (Maloney etc.), 6,106,776 (Borovetz etc.), 6,217,826 (Reeder etc.), 6,348,175 (Borovetz etc.), 6,723,284 (Reeder etc.) and U.S.'s publication number 2004/0219,061 (Reeder etc.) all are incorporated herein by reference.
[0043] developed Paracorporeal respiratory assist lung of the present invention, it is applicable to the patient who just suffers acute pulmonary failure and chronic lung disease acute exacerbation.This design concept is based upon on the clinical success of former oxygenator, and described oxygenator takes out blood from patient's femoral artery, removes carbon dioxide (CO by the available membrane oxygenator of commerce
2) and utilize natural arterial-to-venous pressure gradient that this blood is changed in this femoral vein.The present invention uses ring-type rotation hollow fiber membrane bundle, to increase the gas exchange and to make this device pump blood.The gas exchange that increases makes its surface area than commercial available membrane type respirator is low at present, and the ability of pumping of this rotation fibre bundle make blood flow cross just to be inserted into venous circulation through skin pair lumen cannula.
[0044] main limitation of gas exchange is the diffusion boundary layer that fluid flows and produced along the surface of this tunica fibrosa in the blood oxygenators.This fiber can help to reduce this boundary layer with respect to the effective exercise of this fluid (blood).Among described herein the present invention, the doughnut of this oxygenator is designed to annular beam, and it is around the central shaft rotation.Arrange that on anchor ring this doughnut makes this rotation oxygenator be different from known disc type rotation oxygenator.In such annular configuration, the rotation of this fibre bundle makes fiber have more uniform linear velocity, because all fibers and this rotating shaft have similar distance.Therefore, Paracorporeal respiratory assist lung of the present invention under the rotary speed lower than disc type oxygenator, can reach the gas exchange of given level.
[0045] Paracorporeal respiratory assist lung of the present invention comprises: shell wherein is equipped with fibrous ring; The motor that links to each other with axle, it makes the fibrous ring rotation; And seal and bearing, it separates fluid path with gas path.This near-end and far-end concetrated pipe can be designed to have mechanism, and blade for example is to help this rotation fibre bundle that is mixed into of new blood.This fluid (blood/water) flows through the interior center pathway warp of rotating shaft of this device, and described axle supports this fiber.Along with the rotation of this fluid road warp/fiber module, fluid velocity and the gas exchange of flowing through these fibers can be regulated by the rotary speed of controlling this fibre bundle.Along with the fibrous ring of this device is designed to have fixing distance with pivot, by all fibers of even use, the speed that has realized flowing through these fibers is more consistent, and unlike the disc type oxygenator, its surface along them produces different speed.
[0046] compare with present rotation technique, Paracorporeal respiratory assist lung of the present invention has distinct advantage:
-make fibrae circulares Shu Xuanzhuan, rather than static fibre bundle;
-make fibrae circulares Shu Xuanzhuan rather than dish (near the rotating shaft place, speed does not become zero);
-rotation can be stable/unsettled (the time variation has increased material Transfer and suction is in medium stationary value);
-ring can be prepared to has a series of gas porositys (higher gas porosity causes higher gas exchange, and pumping is had no significant effect);
-this ring can be the bundle that approaches, and it makes that the stationary wall around this bundle is had bigger shearing infiltration;
-haemolysis is not because this rotation fiber self (this device assembles with the porous Rotating Stainless Steel Cage, and described porous Rotating Stainless Steel Cage is as the support during rotating);
-developed various technology to change the gas porosity of this fibre bundle;
As if the feasible Lu Jinggeng that should flow is even in the rotation of-this fibre bundle, so the gas exchange is not subjected to the design or the position influence of this inflow/outflow port;
-suction allows the endermic operation of vein-vein; With
-because the CO that this fibre bundle rotation produces
2The removal level, can realize breathing the CO of dialysis or low flow velocity
2Remove.
[0047] as shown in Figure 1, Paracorporeal respiratory assist lung (PRAL device) is configured with Motor Drive 28, and it is positioned over patient 25 health outside.This PRAL device comprises blood flow catheter 21, and it can be inserted in this patient's the femoral vein 27.Alternatively, this PRAL blood catheter can be inserted into by this patient's jugular vein 29.The near-end 45 of this PRAL blood catheter 21 can be inserted into by otch on patient's leg 23 or endermic inlet, to put in the femoral vein.The vascular system of this conduit by this patient is incorporated into the position near heart of patient, so that this far-end 45 is near hearts, for instance in vena cave or near vena cave.This PRAL blood catheter can be designed to have two-chamber, and its one side 47 is the blood inlet, and second limit 46 is the blood outlet.With the distal end of catheter fluting may be favourable, makes the blood port of export 46 extend outside the end of blood inlet opening 47 like this.
[0048] speak of Fig. 2 A, 2B and 2C now, an embodiment of Paracorporeal respiratory assist lung 20 of the present invention comprises the shell 22 around stationary core 24.Rotation fibre bundle 26 is in the enclosure involved, and around stationary core.Motor operated driving mechanism 28 operationally is connected on the main casing of Paracorporeal respiratory assist lung.This stationary core comprises the main body 30 that contains blood ingress port 32, and it allows blood to diffuse through the fiber mat 40 of this rotation fibre bundle from this stationary core.This shell further design has blood outlet port 34, and it can be connected on the sleeve pipe (not shown) along the blood inlet, and described sleeve pipe is designed to be inserted in this patient's the vascular system (Fig. 1).This shell further has been designed the gas access mouth of pipe 36 and gas outlet tube mouth 38, and they and this rotate the fiber mat generation fluid communication of fibre bundle.This fiber mat is fixedly joined on the supporting mechanism 42, and described supporting mechanism is connected on the driving shaft 44, is connected on the motor operated driving mechanism to described driving shaft operability.The support driving mechanism of this fiber mat can be designed to wire or mesh cage (Figure 16 A, 16B) or other suitable embodiment, passes this fibre bundle to strengthen blood flow, will any infringement of blood constituent be minimized simultaneously, for example limits haemolysis.
[0049] speak of Fig. 3 A, 3B, 3C and 3D now, Paracorporeal respiratory assist lung 50 of the present invention comprises the shell 52 at center, and it contains blood outlet port 64.First end portion 54 of this shell comprises blood ingress port 62 and gas inlet pipe mouth 66.Second end portion 58 of this shell comprises the gas vent mouth of pipe 68.First and second ends of this shell can be designed screw thread or other mechanism, so that the end of this shell is fastened on this center-side.Rotation fiber bundle mechanism 56 is designed to place in this shell, and comprises the supporting mechanism (not shown), allows blood to flow through this fiber from the inlet of this shell simultaneously to keep this fibre bundle.This fibre bundle can form from fibrae circulares pad 60, described fibrae circulares pad 60 and gas access and gas vent generation fluid communication.This rotation fiber bundle mechanism further comprises driving shaft 74, and it can be mechanically connected on the motor mechanism (not shown).This rotation fiber bundle mechanism can further be designed potting 72, with the fiber ends of Muller's fibers pad.
[0050] speak of Fig. 4 A and 4B now, the Paracorporeal respiratory assist lung 80 general designs that are used for test purpose have shell 82, and it surrounds the rotation fibre bundle 86 that contains stationary core 84; This fibre bundle and this shell have been arranged.Blood 100 enters this device by the arrival end 92 of this stationary core.Load has the scavenging 96 of oxygen to enter the rotation fibre core, so that oxygen and carbon dioxide are entered blood and leave blood by exchange along fibre bundle.This rotation fibre bundle has been designed driving shaft 104, so that this fibre bundle is with respect to this stationary core and shell rotation.About Figure 20,21 and 22, use Paracorporeal respiratory assist lung of the present invention, CO on its realization (a) unit are
2Removal increase by 133%; (b) O on the unit are
2Removal increase by 157%; (c) under 1500rpm, with respect to 50mmHg, produce flowing of 1L/min (rise/minute), the experimental condition that comprises: (i) test fluid flow is the blood of ox in water or the slaughterhouse; (ii) rate of flow of fluid is at 750ml/min; (iii) the scavenging flow velocity is at 6.5l/min; (iv) loop temperature is at 37 ℃; (the v) pCO of porch
245+/-5mmHg; (vi) porch O
2Saturation degree 65%; (vii) the hematocrit of blood is 35%; (viii) the HC of blood is upgraded to 12.1 milligrams (mg/dl) at per minute.
[0051] when the hollow fiber membrane bundle with ring-shaped cylinder geometry is rotated, this bundle can play the effect of pump.Therefore yet this intrafascicular fluid is carried secretly (the relative velocity vanishing between fiber and the fluid) significantly in fiber rotatablely moves, and rotation does not increase the mass transfer efficiency of fibre bundle, thick at the most which floor.Hollow fiber membrane bundle can be by vibration (swing (oscillated)) to reduce the fluid carry-over phenomenon, because vibration hinders the speed of fluid to reach the speed of fiber.One aspect of the present invention is: introduce vibration in the stable rotation of hollow fiber bundle, keep its suction capacity simultaneously to increase mass transfer efficiency.
[0052] shown in Figure 18 and 19, Paracorporeal respiratory assist lung of the present invention serves as the integrated mass transfer device of pump/hollow-fibre membrane, and when the rotary speed of this fibre bundle is changed rapidly, the raising that shows material Transfer.In order to improve the gas switching performance that Paracorporeal respiratory assist lung can reach, the various rotary modes of this fibre bundle can be employed, for example stable state rotation, unstable state rotation, pure vibration rotation and the rotation of dependent form At All Other Times.As those of ordinary skills will understand, known and the gas-permeable fibers that is developed can be used to the present invention, used hollow microporous polypropylene fiber and gas-permeable fibers in blood oxygenators at present for example.This gas-permeable fibers can comprise the gas permeability polymer coating, and can be combined with non-factor component.
[0053] this rotating driving device can comprise the motor that is connected with this fibre bundle.Oxygen Flow is crossed this doughnut, and fluid (for example, water or blood) can be introduced into this fibre bundle by internal diffuser.Sealing and bearing separate gas and fluid path, and allow this fibre bundle externally to be rotated under the effect of motor.The brushless DC servo-motor can be controlled the motion of this hollow fiber membrane bundle.The user of Paracorporeal respiratory assist lung can use the frequency and the amplitude of the computer settings vibration that links to each other with controller.This controller sends the driving signal of carrying out input motion, accepts simultaneously to feed back and speed is made adjustment from motor.
[0054] in the further embodiment of the present invention, Paracorporeal respiratory assist lung is designed to increase the gas porosity of this rotation fibre bundle.The gas porosity that increases provides more that the multithread body flows through this fibre bundle, has therefore increased the mass transfer efficiency of this device integral body.The extra gas porosity of this fibre bundle is to produce by several possible approach, includes but not limited to, uses the member of getting the interval to produce the space between fibrage, removes one every a fiber in this pad, and uses the more fiber of minor diameter.In addition, Support Level also can be removed from fabric, and Paracorporeal respiratory assist lung can be designed this fibre bundle so concetrated pipe is nearer relatively " fluffy (puffout) ".
[0055] shown in Figure 17 A and 17B, be immersed in polyurethane or other suitable material by the felt that will approach bar, can pass fiber mat at interval and be placed.According to the present invention, when this fiber mat was rolled, this felt was also rolled-up together with it, and it hardens along with adhesive dries then.So should between this fiber, just produce extra space through the felt of super-dry.Yet, the fiber surface area of this felt institute contact position, but be not included in the operation table area of Paracorporeal respiratory assist lung.Alternatively, by take one away every a fiber in this fiber mat, this fiber mat just is left the space of many openings, and it contains parallel and does not have fiber.Though the unchanged total surface area of fiber can be identical with number, these fibrous septums are bigger, therefore produce " bundle of puffy ".In addition, the gas-permeable fibers that external diameter reduces also can be used to produce the higher device of gas porosity.The gas porosity that this fibre bundle is higher is because the reduction of fibre density, that is: the density of fiber in the fiber mat of less external diameter is less than the fiber mat that contains big outer diameter fibers.The space that has more openings under the situation of having only parallel to exist, the design class of described situation and the fibre bundle under fiber situation of a fiber removal seemingly.
[0056] under low relatively vein-vein velocity of blood flow (500-1000ml/min), Paracorporeal respiratory assist lung of the present invention has been realized significant CO
2Remove (100-120ml/min), and do not need independent pump.Figure 23-25 shows: fiber bundle porosity, and to the gas exchange of Paracorporeal respiratory assist lung and the influence of suction performance.Make the external assisted respirator of two kinds of prototypes, fiber bundle porosity is 0.43 and 0.83; But similar in other respects, the film surface area is respectively 0.42 square metre of (m
2) and 0.50m
2This device water is as test fluid flow, and when at 31/min, the gas in the test flowloop exchanges.Paracorporeal respiratory assist lung with higher bundle gas porosity (higher bundleporosity), under 1500rpm, the CO of realization
2Remove and be 173ml/min/m
2By comparison, having low prototype of restrainting gas porosity is 190ml/min/m
2Under the situation of bovine blood, have the Paracorporeal respiratory assist lung of higher bundle gas porosity, under 1500rpm, when velocity of blood flow only is 750ml/min, reach 182ml/min/m
2CO
2Removal speed.Carry out an independent pump test in water, as test fluid flow, under the flow velocity of 0.75l/min, under 1500RPM, the fibre bundle that has than high porosity (higher porosity) produces 67mmHg with water; By comparison, have the fibre bundle that hangs down gas porosity and only be 52mmHg.Fibre bundle with gas porosity of increase is in ten percentage points of gas exchange target (10%), and suction capactity is with consistent by the blood flow through skin sleeve pipe generation 750ml/min less than 20Fr.
[0057] speak of Fig. 5 A to 5P now, an embodiment of this PRAL device comprises the shell 520 that contains top 524 and bottom 522.The top of this PRAL device 500 comprises blood inlet 530 and gas vent 545.The bottom of this shell comprises gas access 540 and blood outlet port 535.This embodiment of this PRAL device comprises the rotation fibre bundle with external drive jointing 525.Shown in Fig. 5 D, this driving mechanism 525 is connected to inner Join device 527, and it can withdraw from and arrive fibre bundle 550.This PRAL device comprises stationary core 560, and it is designed to have inner chamber or blood catheter, and inner chamber or blood catheter have outer end 532 and inner 534.The inner of this blood catheter is connected on the impeller device 570, and described impeller device comprises a plurality of bow-shaped arms 572, and it helps blood flow is imported this fibre bundle 550.This PRAL device has been designed annular space 590, and it is between rotation fibre bundle 550 and shell 520.Blood flow, it is from entering the mouth 530, and flows into fibre bundle 550 and gaps 590, outflow port 535 from blade 570.Scavenging, oxygenated air for example 540 enters this PRAL device from entering the mouth, this fibre bundle 550 of flowing through, wherein carbon dioxide and oxygen and blood exchange, and the port 545 of gas from the top 524 of this PRAL device that is loaded with carbon dioxide left away.The top part of this PRAL device further design has holding device 565, and it is fastened on core 560 and blood catheter 530 in the shell 520.
[0058] speak of Fig. 6 now, an optional embodiment 600 of this PRAL device comprises shell 620, and shell 620 has blood and fluid intake 630; And fluid issuing 635 is through these inlets, through conduit 632, and described conduit is branched into first conduit 634 and second conduit 636, and they import fibre bundle 650 with blood.This fibre bundle is connected on the driving mechanism 625, and described driving mechanism links to each other with Motor Drive 628.In a plurality of sealing mechanisms 690 are included in, separate with gas path will rotate fibre bundle and blood flow.Gas enters this system by the inlet 640 that links to each other with this fibre bundle, and discharges from gas vent 645, carries out fluid communication with this fibre bundle 650 therebetween.
[0059] speak of Fig. 7 now, the optional embodiment 700 of this PRAL device comprises the shell 720 that has blood and fluid intake 730, and fluid issuing 735 is through these inlets, through conduit 732, and conduit 732 imports fibre bundle 750 with blood.This fibre bundle is connected on the driving mechanism 725, and described driving mechanism links to each other with Motor Drive 728.A plurality of sealing mechanisms 790 are comprised, will rotate fibre bundle and blood flow, separate with gas path.During carrying out fluid communication with this fibre bundle 750, gas enters this system by the inlet 740 that links to each other with this fibre bundle, and discharges from gas vent 745.This specific embodiment further comprises the stationary core 760 that is positioned at these rotation fibre bundle 750 inside.
[0060] Fig. 8 that speaks of now is the optional embodiment 800 according to PRAL device of the present invention.This PRAL device comprises shell 820, and it contains bottom 822 and the top 824 that is fastened on the main body 820.The top of this device comprises the blood inlet 830 that links to each other with conduit 832, and described conduit 832 has far-end 834, plays the effect that blood flow is offered the core 860 at center, and comprises impeller 870.Blood flow stream is crossed rotation fibre bundle 850, wherein rotates fibre bundle 850 and is connected on the driving mechanism 825.Gas enters by gas access end 540, the bottom 822 of this shell of flowing through and gas vent 845, and described gas access end 540 carries out fluid communication with fiber gas bundle 850.Circlet shape gap 890 is between the shell 820 of rotation fibre bundle 850 and this device 800.Various sealings and other mechanism are used to air-flow and blood flow are separated.Similarly, screw and other mechanism are used to the various piece of fastening this shell.In addition, various sealings and bearing are used to allow driving mechanism and rotation core to move freely in this shell.
[0061] speaks of Fig. 9 now, comprise: the magnetic coupling that is used to make the core of center to be rotated according to the optional embodiment 900 of PRAL device of the present invention.This PRAL device comprises the shell 920 that contains bottom 922 and top 924.This top comprises blood entry conductor 930, and it is connected on the blood distribution blade 970, and described blood distributes blade to be incorporated in the rotation core 960.The bottom of this main body 922 comprises sealing and bearing 980 and bearing pin or other mechanism 982, so that this rotation core is supported in this shell.This embodiment of this PRAL device comprises static fibre bundle 950, and it contains gas access 940 and gas vent 945.Blood through this bundle 950, passes recirculation gap 990 from the 930 inflow internal clearances 922 that enter the mouth, and flows out from the blood port of export 935.Inside between this rotation core and this shell and cyclic gap allow repetitive cycling or the whirlpool effect shown in the arrow 996.This rotation core is connected on the external device (ED) by magnetic force by being fastened to the magnet 984 and 986 on the rotation core.
[0062] speak of Figure 10 A and 10B now, the optional embodiment 1000 of this PRAL device can further design the rotation core mechanism.This PRAL device comprises shell body 1020, and it contains bottom 1022 and top 1024.Motor operated driving mechanism 1025 is designed in the inside of described bottom.Gas access 1040 also is designed on the bottom of this shell.Static fibre bundle 1050 is placed in the main body 1020 of this shell, and it is designed to accept rotation cord 1060 (rotatingcord 1060).Various sealings and fastening means 1062,1064,1066 and 1068 are displayed among Figure 10 B.
[0063] speak of Figure 11 now, this PARL device 1100 also has been designed rotation core mechanism and static fiber bundle.This device has been designed shell 1120, and it contains bottom 1122 and top 1124, and they are secured together, forms parts.The bottom of this shell comprises motor operated driving mechanism 1125, and it operationally is secured on the rotation core 1160.Blood enters by blood arrival end 1130, flows on the blade 1170 from this upper parts of components.Blood passes static fibre bundle 1150 from the blade internal clearance 1192 of flowing through, and flows to outer recirculation gap 1190 and flows through blood port of export (not shown).Gas enters fibre bundle by arrival end 1140, and flows to design and discharge after the outlet 1145 on this PRAL device top passing fibre bundle.This gas access is positioned on the bottom 1122 of this PRAL shell 1120.Be fastened to the stabilizing means on the bottom of this shell, comprise bearing and sealing, be designed to accept rotary drive mechanism 1125.Other various sealings and bearing can be used, with air-flow and blood flow separately and to prevent that these fluids from leaking.
[0064] speak of Figure 12 A and 12B now, demonstration be the top and bottom perspective views of cutting open about the part of the PRAL device shown in Figure 10 and 11.Shown in Figure 12 A, blood flow is imported into blade 1170, and it has a plurality of arc water conservancy diversion arms 1172.Blood flow continues to flow to internal clearance 1192 from blade, and internal clearance 1192 is placed between rotation core 1160 and the static fiber bundle 1150.This blood flow passes static fiber bundle and flows to outer recirculation gap 1192, and flows out from the blood port of export 1135.
[0065] Figure 26 is FEMLAB CFD (Fluid Mechanics Computation (computational the fluiddynamics)) simulation of the blood flow that taken place in an embodiment of PRAL device of the present invention.What show is that described PRAL device has rotation fibre bundle 2650 about the longitudinal cross-section of the FEMNLAB model of the situation of PRAL device, and rotation fibre bundle 2650 is placed between static inner casing 2600 and the static shell 2700.Between shell 2700 and fibre bundle 2650, form first outer gap 2690, and between inner casing 2600 and fibre bundle 2650, formed second internal clearance 2692.The rotation of fibrae circulares bundle 2650 in the outer gap 2690 between this rotation fibre bundle 2650 and this static shell 2700, has produced Taylor vortex 2635 (Taylor vortices 2635).Vortex 2635 externally in the gap 2690, has caused that pressure changes 2630.This pressure variations disturb the blood flow pattern 2620 of fibre bundle 2650 inside, the relative velocity between rotation fiber and the blood flow is increased, therefore improved the gas exchange.In this of this PRAL device and other embodiment, there is preferred magnitude range in the size of the outer gap 2690 between fibrae circulares bundle 2650 (rotation or static) and shell 2700.Gap length should be just in time enough big, passes outer gap 2690 up to the pressure drop that designed device outlet is produced to satisfy blood, so consequently can not stop the radially blood flow that passes this fibrae circulares bundle 2650 to be set up relatively uniformly and distribute.This gap length will be decided on the permeability (gas porosity) and the thickness of this fibre bundle.
[0066] speak of Figure 13 now, the optional embodiment of PRAL device of the present invention except static fiber bundle, comprises the fibre bundle that is equipped with the rotation core.This PRAL device comprises the shell 1320 with bottom 1322 and top 1324.This top comprises blood entry conductor 1330, and blood entry conductor 1330 is connected to blood and distributes on the blade 1370, and described blood distributes blade to be incorporated in the rotation core 1360.The bottom of this main body 1322 comprises sealing and bearing 1380 and bearing pin or other mechanism 1382, so that this rotation core is supported in this shell.This embodiment of this PRAL device comprises static fibre bundle 1350, and it contains gas access 1340 and gas vent 1345.Blood through bundle 1350, passes backflow gap 1390 (recirculation gap 1390) from the 1330 inflow internal clearances 1322 that enter the mouth, and flows out from the blood port of export 1335.Inside and cyclic gap between this rotation core and this shell allow circulation or eddy effect.The magnet 1384 and 1386 of this rotation core by being fastened to this rotation core is connected on the external device (ED) by magnetic force.Extra conduit 1385 is comprised, makes gas flow into and flows out and rotate fibre bundle 1355.
[0067] speak of Figure 14 now, demonstration be block diagram, PRAL device 1400 has been described, its configuration has the controller in the electronic computer system 1410 of user interface 1420, it has battery pack and charger 1430 and AC-DC power supply 1435.This system can further dispose Ethernet (Ethernet) and other external communication device: 1425,1427.Blood enters this PRAL device by suction line 1430, and enters patient by the port of export 1435 outflows, and it has release mechanism, for example flows and air-foam detector.Air intake 1440 is provided, and can be connected to wall type oxygen supply unit 1442 or oxygen tank 1444, to install make-up gas to this.Humidifier and/or heater 1475 can be inserted between air intake and this PRAL device 1400.Scavenging exhaust line 1445 can comprise: dehydrator 1446, and carbon dioxide and oxygen analyser 1448.Other valve and ventilating mechanisms can be included, as safety component.For instance, vavuum pump 1490 can be inserted between the PRAL device 1400 and the port of export 1495, and to serve as release mechanism, so consequently: this system has negative pressure, makes can not produce bubble in patient's vascular system.
[0068] Figure 15 has described the optional embodiment of Paracorporeal respiratory assist lung of the present invention.This PRAL device 1500 also designs rotation core mechanism and static fiber bundle.This device has been designed shell 1520, and it contains bottom 1522 and top 1524, and they are secured together, forms a single part.The bottom of this shell comprises driving mechanism 1580,1582, and it operationally is secured on the rotation core 1560.Blood enters by blood arrival end 1530, enters from this upper parts of components, is sent on the impeller 1570, and wherein impeller 1570 has a plurality of spokes 1572.Blood passes static fibre bundle 1550 from the impeller internal clearance 1592 of flowing through, and flows through external reflux cyclic gap 1590 and flows out blood port of export (not shown).Gas enters this fibre bundle by the arrival end (not shown), and flows to design and discharge after the outlet (not shown) on this PRAL device top passing this fibre bundle.This gas access is positioned on the bottom 1122 of PRAL shell 1120.This gas access is positioned on the bottom 1122 of PRAL shell 1120.This device comprises magnet 1584 and 1586, is used to be connected to external driver device.Other various sealings and bearing can be used, so that air-flow and blood flow are separated; And in case these fluids leak.This magnet and shell can be designed, and make this rotation core be suspended in more than the bottom of this shell, have therefore reduced the frictional force in this device.Other various sealings and bearing can be used with air-flow and blood flow separately, and to prevent the leakage of these fluids.
[0069] although particular form of the present invention is set forth, to those skilled in the art, not deviating from inventive concept of the present invention and can carry out various changes, also is tangible.Touch upon the present invention with the use of membrane electrode assembly and fuel cell, only is for example as a reference, and described embodiment will only be considered to exemplary in all fields and not have limited.The present invention can be combined with other specific forms and specialize, and the spirit or the substantive distinguishing features that do not deviate from it.Therefore, except claims, be not intended to limit the present invention.
Claims (20)
1. Paracorporeal respiratory assist lung, it comprises:
Shell, it contains fluid intake, fluid issuing, gas access and gas vent;
A plurality of tubular gas permeability tunica fibrosas, it is configured to the formation fibre bundle, described fibre bundle is placed in the described shell, and is connected to described gas access and described gas vent and with them fluid communication takes place, and wherein first gap design is between described shell and described fibre bundle;
Stationary core, it is placed in the described fibre bundle, and wherein second gap is designed between described core and the described fibre bundle; With
Make the instrument of described fibre bundle rotation, wherein said shell, fibre bundle and core are designed, and pass described fibre bundle and flow into described fluid issuing so that enter the fluid of described fluid intake.
2. Paracorporeal respiratory assist lung according to claim 1, the wherein said instrument turbulization in described first gap that makes described fibre bundle rotation.
3. Paracorporeal respiratory assist lung according to claim 1, the wherein said instrument of described fibre bundle rotation that makes produces a plurality of Taylor vortexs in described first gap.
4. Paracorporeal respiratory assist lung according to claim 1, wherein said fibre bundle has been designed gas porosity, and it allows uniform fluid to flow through described fibre bundle.
5. Paracorporeal respiratory assist lung according to claim 1, wherein said first gap and second gap are designed, and make fluid be optimized by described fibre bundle.
6. Paracorporeal respiratory assist lung according to claim 1, it further comprises the instrument of the rotary speed that is used to change described fibre bundle.
7. Paracorporeal respiratory assist lung according to claim 1, it further comprises the instrument of the direction of rotation vibration that makes described fibre bundle.
8. Paracorporeal respiratory assist lung according to claim 1, it further comprises the two-chamber sleeve pipe, described two-chamber sleeve pipe is designed to be inserted in patient's the venous circulation, blood flow is provided and accepts blood flow from the fluid issuing of described shell with the fluid intake to described shell.
9. Paracorporeal respiratory assist lung, it comprises:
Shell, it contains fluid intake, fluid issuing, gas access and gas vent;
A plurality of tubular gas permeability tunica fibrosas, it is configured to the formation fibre bundle, described fibre bundle is placed in the described shell, and is connected to described gas access and described gas vent and with them fluid communication takes place, and wherein first gap design is between described shell and described fibre bundle;
Core, it is placed in the described fibre bundle, and wherein second gap is designed between described core and the described fibre bundle; With
Make the instrument of described core rotation, wherein said shell, fibre bundle and core are designed, and pass described fibre bundle and flow into described fluid issuing so that enter the fluid of described fluid intake.
10. Paracorporeal respiratory assist lung according to claim 9, the wherein said instrument turbulization in described second gap that makes this core rotation.
11. Paracorporeal respiratory assist lung according to claim 9, the wherein said instrument of this fibre bundle rotation that makes produces a plurality of Taylor vortexs in described second gap.
12. Paracorporeal respiratory assist lung according to claim 9, wherein said fibre bundle has been designed gas porosity, allows uniform fluid to flow into described fibre bundle.
13. Paracorporeal respiratory assist lung according to claim 9, wherein said first gap and second gap are designed, and make fluid be optimized by described fibre bundle.
14. Paracorporeal respiratory assist lung according to claim 9, it further comprises the instrument of the rotary speed that is used to change described fibre bundle.
15. Paracorporeal respiratory assist lung according to claim 9, it further comprises the instrument of the direction of rotation swing that makes described fibre bundle.
16. Paracorporeal respiratory assist lung according to claim 9, it further comprises the two-chamber sleeve pipe, described two-chamber sleeve pipe is designed to be inserted in patient's the venous circulation, blood flow is provided and accepts blood flow from the fluid issuing of described shell with the fluid intake to described shell.
17. Paracorporeal respiratory assist lung according to claim 9, wherein said core comprise a plurality of tubular gas permeability tunica fibrosas.
18. Paracorporeal respiratory assist lung according to claim 9, it further comprises impeller, to carry out fluid communication with fluid intake.
19. Paracorporeal respiratory assist lung according to claim 9 wherein makes the instrument of described core rotation comprise magnetic coupling.
20. Paracorporeal respiratory assist lung, it comprises:
Shell, it contains blood inlet, blood outlet, gas access, gas vent and carries out the impeller of fluid communication with described blood inlet;
A plurality of tubular gas permeability tunica fibrosas, it is configured to the formation fibre bundle, described fibre bundle is placed in the described shell, and is connected to described gas access and described gas vent and with them fluid communication takes place, and wherein first gap design is between described shell and described fibre bundle;
Core, it is placed in the described fibre bundle, and wherein second gap is designed between described core and the described fibre bundle;
Make the instrument of described core rotation, wherein said shell, fibre bundle and core are designed, and pass described fibre bundle and flow into described fluid issuing so that enter the fluid of described fluid intake, and the wherein said instrument of described core rotation that makes comprises magnetic coupling; With
The two-chamber sleeve pipe, it is designed to be inserted in patient's the venous circulation, blood flow is provided and accepts blood flow from the blood outlet of described shell with the blood inlet to described shell.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310065932.XA CN103381277B (en) | 2005-04-21 | 2006-04-21 | Paracorporeal respiratory assist lung |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US67388505P | 2005-04-21 | 2005-04-21 | |
| US60/673,885 | 2005-04-21 | ||
| US60/688,809 | 2005-06-08 |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410710088.6A Division CN104524654A (en) | 2005-04-21 | 2006-04-21 | Paracorporeal respiratory assist lung |
| CN201310065932.XA Division CN103381277B (en) | 2005-04-21 | 2006-04-21 | Paracorporeal respiratory assist lung |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101262931A true CN101262931A (en) | 2008-09-10 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2006800197916A Pending CN101262931A (en) | 2005-04-21 | 2006-04-21 | Paracorporeal respiratory assist lung |
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| CN (1) | CN101262931A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103857418A (en) * | 2011-07-27 | 2014-06-11 | 迈柯唯销售服务德国有限公司 | Electronically controlled gas mixing unit for supplying a sweep gas to an oxygenerator |
| CN115397546A (en) * | 2020-02-18 | 2022-11-25 | 萨尔大学 | Apparatus for removing gas from aqueous liquid |
-
2006
- 2006-04-21 CN CNA2006800197916A patent/CN101262931A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103857418A (en) * | 2011-07-27 | 2014-06-11 | 迈柯唯销售服务德国有限公司 | Electronically controlled gas mixing unit for supplying a sweep gas to an oxygenerator |
| CN115397546A (en) * | 2020-02-18 | 2022-11-25 | 萨尔大学 | Apparatus for removing gas from aqueous liquid |
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Application publication date: 20080910 |