CN107183005A - The apparatus and method for of organ perfusion - Google Patents

Abstract

A kind of organ perfusion's equipment includes the entrance for connecting organ and the outlet for connecting organ, in addition to perfusion loop.The perfusion loop includes：Reservoir, is configured to store perfusion liquid；Waste liquid device；And multiple fluid conduit systems.The multiple fluid conduit systems are used to limit：Connect the trandfer fluid path of the reservoir and the entrance；The backwater fluid path of the reservoir and the outlet is connected, the backwater fluid path is independently of the trandfer fluid path；Connect the waste liquid fluid path of the reservoir and the waste liquid device.Organ perfusion's equipment further comprises：First flow control device, is configured to optionally prevent or allows fluid to flow to the organ from the reservoir via the trandfer fluid path；Second flow control device, is configured to optionally prevent or allows fluid to flow to the waste liquid device from the reservoir via the waste liquid fluid path.

Description

The apparatus and method for of organ perfusion

The cross reference of related application

What the U.S. Provisional Application 62/333467 and on April 7th, 2017 submitted this application claims on May 9th, 2016 were submitted The priority of U. S. application 15/482015, the full content of above-mentioned application is incorporated by reference in the application.

Technical field

This disclosure relates to the management of donor organ, more particularly to a kind of apparatus and method of organ perfusion.

Background technology

The donor organs such as lung are highly perishable, therefore must be transplanted to acceptor as early as possible after donor taking-up In.Conventional method is before implantation acceptor, by donor organ simply stored frozen.Recently, it have developed in organ transplant The system of preceding perfused organ, can extend the time window for making organ keep activity.However, such system it is generally not only complicated but also Costliness, and aggravate cost because of some expendable consumed product parts of heavy dependence.This system is also difficult to transport simultaneously.

The content of the invention

To solve the above problems, the technical scheme that present disclosure is provided is as follows：

A kind of organ perfusion's equipment includes the entrance for connecting organ and the outlet for connecting organ, in addition to perfusion Loop.The perfusion loop includes：Reservoir, is configured to store perfusion liquid；Waste liquid device；And multiple fluid conduit systems.It is described many Individual fluid conduit systems are used to limit：Connect the trandfer fluid path of the reservoir and the entrance；Connect the reservoir and institute The backwater fluid path of outlet is stated, the backwater fluid path is independently of the trandfer fluid path；Connect the reservoir with The waste liquid fluid path of the waste liquid device.Organ perfusion's equipment further comprises：First flow control device, is configured to choosing Prevent to selecting property or allow fluid to flow to the organ from the reservoir via the trandfer fluid path；Second flow is controlled Device, is configured to optionally prevent or allows fluid to flow to the waste liquid from the reservoir via the waste liquid fluid path Device.

Preferably, the perfusion loop further comprises：The reservoir fluid injection fluid limited by the multiple fluid conduit systems Path, the reservoir fluid injection fluid path connects a fluid injection port and the reservoir.

Preferably, the perfusion loop further comprises：The organ fluid injection fluid road limited by the multiple fluid conduit systems Footpath, the organ fluid injection fluid path connects the fluid injection port and the organ；3rd volume control device, is configured to selection Prevent to property or allow fluid via at least one in the reservoir fluid injection fluid path and organ fluid injection fluid path from The fluid injection port outflow.

Preferably, the perfusion loop further comprises：Pump head module on the trandfer fluid path, for from The reservoir receives the perfusion liquid；Adjustment module on the trandfer fluid path, for from the pump head module Receive the perfusion liquid；Leucocyte filter on the trandfer fluid path, is filled for being received from the adjustment module Fluid injection；The first flow control device is arranged between the pump head module and the leucocyte filter.

Preferably, the perfusion loop further comprises the second leucocyte filter；Enter one by the multiple fluid conduit systems The standby trandfer fluid path limited is walked, the standby trandfer fluid path connects described via second leucocyte filter Holder reservoir and the entrance；The perfusion equipment further comprises the 3rd volume control device, the 3rd control dress Put and be configured to optionally prevent or allow fluid to be flowed via the standby trandfer fluid path.

Preferably, the perfusion equipment further comprises：Organ support；Leakage fluid dram in the organ support；By The organ support backwater fluid path that the multiple fluid conduit systems are further limited, the organ support backwater fluid path connection The leakage fluid dram and the reservoir.

Preferably, the multiple fluid conduit systems further define organ support waste liquid fluid path, the organ support Waste liquid fluid path connects the leakage fluid dram and the waste liquid device；The perfusion equipment further comprises the 3rd flow control dress Put, the 3rd control device is configured to optionally prevent or allows fluid via the organ support waste liquid fluid path stream It is dynamic.

Preferably, the perfusion equipment further comprises：Controller, the controller stores multiple running statuses, each Individual running status determines the position of each volume control device, and the controller is configured to and the volume control device In each communicated；Sensor, is configured to produce the measurement of the characteristic of the perfusion liquid；The controller is further matched somebody with somebody The reception measurement is set to, a running status is automatically selected according to the measurement, and based on selected operation shape State controls the volume control device.

Preferably, the perfusion equipment further comprises the input unit for being connected to the controller；The controller enters One step be configured to from the input equipment receive a selected running status, and based on selected running status come Control the volume control device.

Preferably, the first flow control device and the second flow control device have failure state, the mistake Effect state is configured to allow fluid to flow to the waste liquid device from the reservoir via the waste liquid fluid path.

Preferably, the multiple fluid conduit systems further define standby backwater fluid path, the standby backwater fluid Path connects the reservoir and the outlet；The perfusion loop further comprises：On the backwater fluid path Pressure-control valve；And the 3rd volume control device, the 3rd volume control device is configured to optionally guide fluid to pass through A flow path in the backwater fluid path and the standby backwater fluid path.

Preferably, the perfusion equipment further comprises：Disposable assembly, including：The entrance；The outlet；It is described The multiple fluid conduit systems in reservoir, the waste liquid device, and the perfusion loop.And reusable component, including： Base, is configured to detachably support the disposable assembly under operation；The first flow control device；And institute State second flow control device；When the disposable assembly is supported by the base, the first flow control device and institute Second flow control device is stated to be respectively configured as optionally preventing or allow fluid via the trandfer fluid path and described Waste liquid fluid path.

Preferably, the base includes the wall for being used to support the disposable assembly；Wherein described first flow control dress Put with the second flow control device by the reusable modular support, the fluid to connect the neighbouring wall Conduit.

Preferably, the disposable assembly further comprises gas conduit, the gas conduit be connected to gas access with It is connected to the organ；The reusable component further comprises lung ventilator；The disposable assembly and described repeatable Using component include can supporting machinery interface, it is described can supporting machinery interface be configured to connect the lung ventilator and led with the gas Pipe.

Preferably, the disposable assembly further comprises the pump head module being located on the trandfer fluid path, is used for The perfusion liquid is received from the reservoir；The reusable component further comprises pump drive module, the pump driving Module is used to drive the pump head module；The pump drive module and the pump head module can the connections of supporting machinery interface described in Operation.

Preferably, the disposable assembly further comprises the adjustment module being located on the trandfer fluid path, described Adjustment module includes heat exchanger and gas exchanger.And the reusable component further comprises：Heater, configuration For the fluid after heating is transported into the heat exchanger；And gas storage device, it is configured to deliver gas to the gas Body exchanger.

Brief description of the drawings

Embodiments herein is described below in conjunction with drawings below：

Fig. 1 is a kind of schematic diagram of perfusion equipment according to the non-limiting example of present disclosure；

Fig. 2 is showing when perfusion equipment is in disassembly status in Fig. 1 according to the non-limiting example of present disclosure It is intended to；

Fig. 3 is the schematic diagram in the perfusion loop of perfusion equipment in Fig. 1 according to the non-limiting example of present disclosure；

Fig. 4 is some additional components for carrying perfusion equipment in Fig. 1 according to the non-limiting example of present disclosure Perfusion loop as shown in Figure 3 schematic diagram；

Fig. 5 A and Fig. 5 B are the flow control dresses of perfusion equipment in Fig. 1 according to the non-limiting example of present disclosure The schematic diagram put；

Fig. 6 is the schematic diagram of the ventilating return of perfusion equipment in Fig. 1 according to the non-limiting example of present disclosure；

Fig. 7 is the flow chart element of the operation method of perfusion equipment in Fig. 1 according to the non-limiting example of present disclosure Figure；

Fig. 8 is the method for the end operation of perfusion equipment in Fig. 1 according to the non-limiting example of present disclosure FB(flow block)；

Fig. 9 is showing for the example embodiment in perfusion loop in Fig. 3 according to the non-limiting example of present disclosure It is intended to；

Figure 10 A and Figure 10 B are the reservoirs in perfusion loop in Fig. 3 according to the non-limiting example of present disclosure Schematic diagram；

Figure 11 is the partial view of embodiment in Fig. 9 according to the non-limiting example of present disclosure；

Figure 12 is the other partial view of embodiment in Fig. 9 according to the non-limiting example of present disclosure；

Figure 13 is the another partial view of embodiment in Fig. 9 according to the non-limiting example of present disclosure；

Figure 14 is the particular elements relative position of embodiment in Fig. 9 according to the non-limiting example of present disclosure Schematic diagram.

Embodiment

Fig. 1, which is shown in a kind of schematic diagram of organ perfusion's equipment 100, text, is referred to as equipment 100.Such as will be hereinafter detailed Carefully describe, at least one link that equipment 100 can be used in the assessment, treatment and transport of donor organ 104.In this reality Apply in example, donor organ is a pair of the lung (examples for obtaining and being implanted into subject patient (patient not shown in Fig. 1) from donor Such as, the lung of the mankind).Described below is that equipment 100 is used for the operation of in vitro perfusion, however, in other embodiments, equipment 100 can be used for intracorporeal organ perfusion.In the following description it will also be apparent that equipment 100 or its deformation also may be used For other a variety of organs, such as kidney, heart and liver.

Generally, equipment 100 is configured as by providing the chamber that is substantially isolated from the outside organ 104 come for device Official 104 provides a sterile environment substantially.Equipment 100 is also configured to allow to irrigate any suitable stream to organ 104 Body (be based at least partially on and be poured the property of organ to select) with organ 104 can be carried out it is mentioned above assessment and control Treat, and extend the time that organ 104 can be used for transport.When equipment 100 be applied to some organs, such as lung when, can also by with It is set to organ 104 and is passed through any appropriate gas or mixed gas, organ 104 can be analyzed and treated.When setting When being applied to other organs for 100, equipment 100 can be additionally configured to remove liquid (for example, the urine in kidney, liver In bile).

Further, as described below, equipment 100 is configured as movably, for example, can be from donor site to fortune Defeated instrument (for example, aircraft), then from means of transport to acceptor site (for example, operating room of hospital).Further, equipment 100 some components are disposable, and other assemblies are reusable.

In the present embodiment, equipment 100 includes disposable assembly 108 and reusable component 112.Disposable assembly 108 include organ support 114, for example, can place the pallet of organ 104, in addition to a perfusion loop, organ 104 can be entered Row perfusion mentioned above.It will be apparent to those skilled in the art that when equipment 100 is applied to the body of organ 104 During interior perfusion, (it be able to can essentially be omitted) without using organ support 114.When equipment 100 is applied to internal perfusion, organ 104 are supported in patient's body, therefore do not need outward sense's support.Disposable assembly 108 also includes a protection dome 115 (in other embodiments or non-domed shape), protection dome 115 can be connected with the top of disposable assembly 108, The chamber substantially sealed off of one receiving organ 104 is provided.Sealing can be airtight, may not be airtight.If no It is airtight, then sealing is preferably waterproof.When there is ventilating return, disposable assembly 108 also includes the one of ventilating return Part.

The miscellaneous part that reusable component 112 includes the control device in perfusion loop and is described in more detail below. When there is ventilating return, the miscellaneous part can include the remainder of ventilating return.The part of reusable component 112 (for example, there are rigid walls and structural support can be provided for part) can be contained in a housing, and the housing can also be wrapped Include the wheel that can move equipment 100 or other mobile devices.

As shown in Fig. 2 disposable assembly 108 can be separated with reusable component 112, so as to for example from mentioned above Means of transport transport reusable component 112 and organ 104 arrives acceptor site, or only so as to from disposable assembly Organ 104 (for example, organ 104 is implanted into subject patient) is removed on 108 to remove afterwards and change disposable assembly 108.

Reusable component 112 includes a base 200, and base 200 is configured as in running status (such as Fig. 1 institutes Show) releasedly support disposable assembly 108.Base 200 can include various structures arrangement.In reality as depicted in figs. 1 and 2 Apply in example, base 200 includes 3 surfaces 200-1,200-2 and 200-3.When being in running status after the assembling of equipment 100, often One surface is all contacted with the corresponding surface of disposable assembly 108.However, a variety of other structures can also be applied to base 200.For example, in other embodiments, base 200 can include the single surface similar with surface 200-1, for repeatable Use support disposable assembly 108 on component 112.In the following description it is readily apparent that the structure division of base 200 take Certainly the arrangement of the physical connection between reusable component 112 and disposable assembly 108, is ventilated back with intactly being constituted Road, control perfusion loop and other functions of realizing equipment 100.

As described above, disposable assembly 108 includes a perfusion loop.Perfusion loop generally make perfusion liquid in reservoir and Circulated between organ 104, to provide nutritional ingredient (for example, glucose) to organ 104, Metabolic byproducts are discharged from organ 104 Thing, alternatively, also allows to carry out multiple assessment and treatment activity to organ 104.Fig. 3 is gone to, perfusion loop is retouched in detail State.

As shown in figure 3, perfusion loop includes a reservoir 300 for being configured as storing perfusion liquid.Perfusion liquid can be Prepare can to organ 104 convey nutritional ingredient, and from organ 104 discharge metabolic by-product any suitable liquid. In other embodiments, perfusion liquid can be salt solution, water or similar liquids, for example, need not convey nutritional ingredient, but still When so needing to discharge the situation of metabolic by-product.In the present embodiment, perfusion liquid is STEEN Solution^TM.Such as will below Middle detailed description, reservoir 300 can have rigid exterior wall or flexible outer wall (or its any appropriate combination), described Outer wall is made of any material with suitable biocompatibility and liquid impermeable, such as plastics.Reservoir 300 Size depend on equipment 100 application.In the present embodiment, equipment 100 is arranged to transport lung, and reservoir 300 can be with Internal capacity with about 2L.It will be apparent, however, that reservoir can be with various other suitable in other application Volume.

Perfusion loop also includes the waste liquid device 304 for being configured as receiving perfusion liquid as described above in specific run state, Waste liquid device 304 will be described below.Waste liquid device 304 can have any suitable shape and structure, including flexible wall With any outer wall suitably combined of rigid walls, outer wall can by any suitable liquid impermeable material (such as plastics) It is made.

Irrigating loop also includes (being referred to as fluid conduit systems 308) such as many fluid conduit systems 308-0,308-1,308-2, for example Limit the flexible elongate tubular (such as silicone tube, plastic tube or similar) of a plurality of fluid path.In certain embodiments, part or complete Portion's fluid conduit systems 308 can be isolation, for example, by larger sized duct wrap.

Fluid path described in present disclosure allows any conjunction of the liquid by fluid conduit systems and miscellaneous part mentioned above Suitable combination is flowed between two end points.Fluid path is limited by a whole group conduit 308 and miscellaneous part, and wherein liquid can To be flowed along the whole group conduit 308 and miscellaneous part between two-end-point.If thus, for example, two end points (such as liquid storages Device 300 and waste liquid device 304) connected by two sets of fluid conduit systems, in the case that two sets of conduits share some fluid conduit systems, The two end points are also considered as by two different fluid path connections.

Fluid path as described above includes trandfer fluid path, trandfer fluid path connection reservoir 300 and organ branch The entrance 312 of frame 114.Entrance 312 can be, for example, one is connected to organ 104 to convey the intubation of perfusion liquid to it. In the present embodiment, organ 104 is a pair of lungs, entrance 312 can be an intubation for being connected to main pulmonary artery (or, one In a little embodiments, entrance 312 can be a pair of intubations or an intubation with branch outlet, be connected respectively to left and right two In the pulmonary artery of side).In the present embodiment, trandfer fluid path is by fluid conduit systems 308-0,308-1,308-2,308-3,308- 4th, 308-5 and 308-6 is limited, and each fluid conduit systems represents a single long tube.For those skilled in that art It is readily apparent that various other conduit configurations can be used to define trandfer fluid path.The conduit configuration used takes The distance between certainly in the miscellaneous part in trandfer fluid path, and part.

Fluid conduit systems 308 in perfusion loop can also limit backwater fluid path, backwater fluid path connection organ branch The outlet 316 of frame 114 and reservoir 300.Outlet 316 is similar with entrance 312, can be one or a pair of intubation, by fluid Each of conduit 308-7 and the left and right sides pulmonary vein of organ 104 is connected respectively, or (lung is quiet with pulmonary vein Truck Connection Arteries and veins trunk flows into heart atrium sinistrum).Backwater fluid path and trandfer fluid path are separate, that is to say, that backwater stream Body path and trandfer fluid path will not share any fluid conduit systems 308.As shown in Figure 3, backwater fluid path is by fluid What conduit 308-7,308-8,308-9 and 308-10 were limited.

Fluid conduit systems 308 can also limit waste liquid fluid path, waste liquid fluid path connection reservoir 300 and waste liquid device 304.As shown in figure 3, waste liquid fluid path is by fluid conduit systems 308-0 (being shared with the trandfer fluid path of foregoing description) and stream What body canal 308-11 was limited.It is readily apparent that various other groups of fluid conduit systems 308 for those skilled in that art Closing can be for the above-mentioned fluid path (and the fluid path being described below) of offer.For example, waste liquid fluid path can be with Not with trandfer fluid path common fluid conduit 308-0.Instead, in certain embodiments, reservoir 300 can be exclusively for Waste liquid fluid path provides one outlet, fluid conduit systems 308-11 is can be directly connected to reservoir 300, and without being connected to Fluid conduit systems 308-0 brasnch conduct.

Multiple miscellaneous parts can be included by irrigating loop, and conduit 308 can limit multiple extra fluid paths, for even Connect multiple miscellaneous parts.Especially, the perfusion loop in the present embodiment includes the pump head mould being located in trandfer fluid loop Block 320.Pump head 320 drives the fluid (by conduit 308-0 and 308-1) received from reservoir 300 to flow to entrance 312 (i.e. Flow to organ 104).More specifically, pump head 320 drives fluid to entrance 312, also by a fluid regulation module, such as one Individual gas and heat exchange module 324.

In the present embodiment, organ 104 is a pair of lungs, and module 324 is used to remove before perfusion liquid is transported to lung to flow through Oxygen in the perfusion liquid of module 324.Deoxygenation can be by injecting carbon dioxide (or other any suitable mixing into perfusion liquid Gas) realize.Module 324 by gas supply pipe 326 obtain carbon dioxide, gas supply pipe 326 with disposable group The mechanical interface 328 of part 108 is connected.Module 324 can be additionally configured to the perfusion liquid flowed through by heat exchanger control Temperature.In certain embodiments, heat exchanger can be driven by power.In the present embodiment, heat exchange is the fluid of heating Received by the input and output conduit 330 for being connected to interface 328 by module 324, flow through heat exchanger in module 324 and from mould Flow out and realize in block 324.As will be further described below, module 324 can be used for heating perfusion liquid to target temperature Spend (for example, 37 degrees Celsius).In certain embodiments, module 324 can also be operated to cooling perfusion loop (for example, logical Cross the operation of TEC).

It is readily apparent that in other embodiments, the gas exchanges and heat exchange function of module 324 can be by independent Equipment realize (for example, online electric heater can be set at the upstream or downstream of gas exchanges module).Another In a little embodiments, gas exchanges function can be given up completely, such as when organ 104 is its in addition to a lung or a pair of lungs During his organ, it is not necessary to gas exchanges.When in some other embodiments, to other organ perfusions outside lung, gas exchange work It can also can retain, although it is different from mode described herein (for example, increase oxygen rather than titanium dioxide into perfusion loop Carbon).

Also include being located at the leucocyte filter 332 at the downstream of module 324 on trandfer fluid path.For in the art It is readily apparent that leucocyte filter is configured as from perfusion liquid removing leucocyte-removing, otherwise leucocyte for technical staff Can after perfusion liquid flows through organ 104 return reservoir 300 with further by the fluid circulation of organ 104 in accumulation (in device Cause inflammation in official 104).

One or more extra leucocyte filters, such as secondary filter 334 can also be included by irrigating loop.One In a little embodiments, secondary filter 334 can be omitted.And in the present embodiment, secondary filter 334 is as filter 332 Reserve filter provide.According to the length of the run time of equipment 100, filter 332 may be blocked up by biologic materials portion Plug, is produced than larger pressure so as to continue driving perfusion liquid to pump head 320 and flow to organ 104.Accordingly, it would be desirable to disable filter 332 and enable secondary filter 334.It is readily apparent that secondary filter 334 is located at one from reservoir 300 to entrance 312 Standby trandfer fluid path on, in addition to conduit 308-4 and 308-5, standby trandfer fluid path and above-mentioned trandfer fluid road Footpath shares identical conduit 308.In fact, standby trandfer fluid path is limited by conduit 308-12 and 308-13.

Pressure-control valve 336 can be included by irrigating the miscellaneous part in loop, such as check-valves, connect into conduit 308-8 and Between 308-9 (that is, on backwater fluid path).In other implementations, pressure-control valve 336 can be fully located at fluid In conduit, such conduit 308-8 and 308-9 can just be replaced with single catheter.As a rule, pressure-control valve 336 is configured To maintain the pressure of (therefore namely organ 104 intravascular) in conduit 308 in predetermined pressure level.For example, when organ 104 When being a lung or a pair of lungs, predetermined pressure level is about 5mm Hg, thus pressure-control valve 336 cracking pressure about It is 5mm Hg.It is readily apparent that when equipment 100 (or its change) is used for other organs, other perfusions can be used Hydraulic coupling.

One can also be included from outlet 316 to the standby or secondary backwater path of reservoir 300 by irrigating loop.Except with Fluid conduit systems 308-14 instead of outside conduit 308-8 and 308-9, and standby backwater path is by backwater fluid road mentioned above What footpath identical conduit was limited.In other words, standby backwater path allows perfusion liquid to be returned via the bypass of pressure-control valve 336 Reservoir 300, will be described below.

Perfusion loop can include multiple extra fluid paths.Including filter fluid injection path, for connecting note Liquid port 340 and filter 334 and 332.Although fluid injection port 340 (for example, it may be possible to including funnel) shows below organ 104 Go out, but it will be apparent that the part in Fig. 3 is not to be shown according to actual physical layout.In fact, fluid injection port 340 are located at the top of the every other part in perfusion loop, including entrance 312.Filter fluid injection fluid path is by conduit What 308-15,308-5 and 308-12 were limited.

The fluid path in perfusion loop can also include reservoir fluid injection fluid path.Reservoir fluid injection fluid path is used for Fluid injection port 340 and reservoir 300 are connected, and is limited by conduit 308-16 and 308-17.Predictably, reservoir 300 Connection between conduit 308-0 is unobstructed, therefore reservoir fluid injection path can also flow to pump head 320 and module 324 (i.e. Reservoir fluid injection path is not limited only to the fluid injection of reservoir 300), it will be described below.

Organ support backwater fluid path can also be included by irrigating the fluid path in loop, pass through conduit 308-18,308- 19 and 308-17 connection organs support 114 and reservoir 300, and including organ support waste liquid fluid path, pass through conduit 308-18 and 308-20 connection organs support 114 and waste liquid device 304.When equipment 100 is in running status, fluid (including fill Fluid injection and other biological liquid, such as blood) can be from the surface of organ 104 directly off organ 104, rather than pass through outlet 316.These fluid collections are on organ support 114, and organ support can be connected to by providing one or more leakage fluid drams Conduit 308-18.Organ support backwater path and organ support waste liquid path mentioned above allows these fluids to be separately recovered Reservoir 300 is handled into waste liquid device 304.In certain embodiments, a path in above-mentioned path can be omitted.Example Such as, organ support waste liquid path can be omitted, and all fluids from organ support 114 can flow to reservoir 300.And example Such as, organ support backwater path can be omitted, and all fluids from organ support 114 can be guided to waste liquid device 304.

Perfusion loop may be fitted with one or more sensors and sample port.In the present embodiment, flow sensing Device 342 and temperature sensor 344 are arranged on trandfer fluid path.The controller (not shown) of equipment 100 can be from sensing Signal is received in device 342 and 344, (or other any appropriate are used to replace module 324 to control pump head 320 and module 324 Heat exchanger) operation.In addition, perfusion loop can include partial pressure of oxygen sensor 346, it is located at close to entrance 312 and gone out One in mouth 316 or whole.Finally, sample port can include upstream end (sample port 348) and the outlet of entrance 312 At 316 downstream (sample port 350), it can allow for taking out perfusion liquid sample, detected outside equipment 100.In some realities Apply in example, sample port 348 and 350 can use additional on-line sensor auxiliary or replacement, such as oxygen sensor, dioxy Change carbon sensor and pH sensors.

The each part interconnected in perfusion loop by conduit 308 can have the path (not shown) that loses heart, in perfusion Air is allowed to be discharged from above-mentioned part during loop fluid injection (irrigating loop injection perfusion liquid for the first time).In some embodiments In, one or more discouraged paths can be omitted.Perfusion loop in part actual arrangement and be arranged so as to perfusion Association will be described below.

Equipment 100 also includes multiple volume control devices, is configured to optionally prevent or allows perfusion liquid to be carried along above-mentioned The fluid path arrived.That is, can be interacted by one or more volume control devices with fluid conduit systems 308 And optionally block fluid conduit systems to be individually enabled or disable above-mentioned fluid path.Equipment 100 is therefore including multiple operation shapes State, each running status enables according to which bar fluid path and which bar fluid path disables to define.

Various flow rate control device can be used in equipment 100.For example, online valve can be positioned in conduit 308.And In the present embodiment, volume control device is arranged on outside conduit 308, therefore will not contact perfusion liquid.In addition, in the present embodiment In, volume control device is arranged in reusable component 112, when disposable assembly 108 is installed into base 200, flow Control device can be connected with suitable conduit 308.

Turning now to Fig. 4, perfusion loop (as described above, being arranged in the present embodiment in disposable assembly 108) with The particular elements of reusable component 112 are shown simultaneously, including multiple volume control devices 400.Especially, in the present embodiment In, show 8 volume control devices 400-1,400-2,400-3,400-4,400-5,400-6,400-7 and 400-8.Another In some embodiments, the other fluid conduit systems configuration for the volume control device 400 for needing varying number and arrangement can be used, is come Equipment 100 is set to be in running status as described below.

The miscellaneous part of reusable component 112, including pump drive module 404 are also show in Fig. 4, for starting pump First 320.Reusable component 112 can also include complementary mechanical interface 408, be configured to connect with disposable assembly 108 Mouth 328 is supporting, and (perfusion gas source 412 and fluid heating source may be simply referred to as into heating by appropriate liquid or gas line Device) 416 it is connected with module 324.In addition, reusable component 112 includes controller 420, with pump drive module 404, heating Device 416 and input unit 424 (such as keyboard, mouse, touch-screen, keypad or similar) and display device 428 are (for example, LCD is aobvious Display screen is similar, in certain embodiments, can be integrated with input unit 424 when above-mentioned input unit 424 includes touch-screen To together) interconnect.

Controller 420 can also be connected with sensor 342,344 and 346 by wireless or wired mode and (not shown Go out).When above-mentioned connection is wired mode, it is clear that, it can be connected by interface 408 and 328, or by arbitrarily closing The connection of other complementary mechanical interfaces with electrical contact of suitable quantity.It is above-mentioned that controller 420 may be also connected to each The volume control device 400 of description, position is being turned on or off for setting each control device 400, will hereinafter It is described in detail.Connection between controller 420 and control device 400 can be wired and wireless any appropriate combination.

Controller 420 can use any appropriate microcomputer to realize, including one or more integrated circuits, for example with What the non-transitory computer readable storage medium with form of memory (non-volatile, volatibility or its combining form) was connected Processor (also referred to as central processing unit, or CPU).

Reusable component 112 also includes power supply (for example, one or more battery or other any suitable electricity Source).Power supply is controller 420, input unit 424, display device 428 and any other electric drive components provide electric power. In the present embodiment, volume control device 400 is driven by power, the same spy for also having pump drive module 404 and module 324 Determine part (such as TEC mentioned above).Entrance 312, outlet 316, leucocyte filter 332 and 334, pressure control Valve 336 processed, reservoir 300, waste liquid device 304, organ support 114, fluid injection port 340 etc. have been carried out in detail in figure 3 above Description, is not repeated herein.

Before the operation of volume control device 400 discussed further, the knot of volume control device 400 is first more fully described Structure.Shown in Fig. 5 A is a single volume control device 400.Volume control device 400 includes accommodating solenoid component Main body 500, solenoid component is configured to drive an axle (not shown), is located at the head 504 of axle and opens and closes position.Head Portion 504 is configured as abutting fluid conduit systems 308.Therefore, in open position, the end protuberance on head 504 is corresponding to flowing through to lead The fluid flow direction alignment of pipe 308, thus flow of fluid can be allowed.At closed position, swell big with fluid flow direction A right angle is caused into, therefore blocks flow of fluid.In the embodiment using wired connection, volume control device 400 also includes At least one electrical interface 508, for transmitting electric power and control signal to volume control device 400.

Fig. 5 B show the volume control device 400 comprising bracket 512, and bracket 512 may be mounted in main body 500, and It is adjacent with head 504.Bracket 512 includes making the relative opening 516 and 520 that fluid conduit systems 308 are passed through.Bracket 512 also includes Location structure, such as hole 524, for bracket 512 to be navigated into main body 500.In the present embodiment, bracket 512 is disposable The part of component 108, and it is fixed on the position that fluid conduit systems 308 need flow to control.When disposable assembly 108 is placed in bottom When on seat 200, the position of these selections can be such that each bracket 512 is connected with volume control device 400 (for example, by hole 524 It is accurately positioned).Therefore, the adjoining of head 504 fluid conduit systems 308 of volume control device 400, and can allow for or prevent fluid Flowed in above-mentioned fluid conduit systems.

In the case where volume control device 400 is powered off, it (that is, can not be turned on and off its corresponding in precalculated position Fluid conduit systems 308).As described below, in the failure such as powered off, the predetermined invalid position of volume control device 400 is jointly fixed The justice fail safe running status of equipment 100.

Fig. 4 is returned to, as described above, each volume control device can optionally prevent or allow fluid to flow through One in the fluid path stated.Especially, device 400-1 controls the flowing via reservoir fluid injection fluid path；Device 400-2 controls the flowing via filter fluid injection fluid path；Device 400-3 is controlled via organ support waste liquid fluid path Flowing；Device 400-4 controls the flowing via organ support backwater fluid path；Device 400-5 is controlled via waste liquid fluid road The flowing in footpath；Device 400-6 controls the flowing via trandfer fluid path；Device 400-7 is controlled via standby trandfer fluid road The flowing in footpath；And device 400-8 controls are via the flowing of standby backwater fluid path.

Volume control device 400 can be independently controlled to enable or disable the combination of any number of above-mentioned fluid paths. The combination of each (therefore also having disabling) fluid path enabled is properly termed as a running status of equipment 100.At this In embodiment, controller 420 is configured as storing multiple running statuses, and each running status is by volume control device What 400 one group of position was determined.Controller 420 is configured to based on any input received by input unit 424 Data (for example, operator of slave unit 100) or automatically determining (for example, being based on from above-mentioned biography based on controller 420 itself The data that sensor is received), one in the running status of storage is selected, and send control signals to volume control device 400 To perform the running status.

In further embodiments, the position of running status volume control device 400 corresponding with its is stored in controller In can omit.In these embodiments, controller 420 can be configured as receiving input data from input unit 424, refer to The position of each fixed volume control device 400.That is, in these embodiments, the operator of equipment 100 not only needs Select running status, in addition it is also necessary to the position of each volume control device 400 is indicated to controller 420.Implement other In example, aforesaid operations mode (i.e. the storage running state of controller 420 and operator's manual administration running status) can be combined.Example Such as, controller can as described above store and perform running status, can also be in response to from the predetermined defeated of input unit 424 Enter, managed with being switched to manual running status, it is allowed to the operator of equipment 100 equipment 100 is performed preferably control (for example, Equipment 100 is set to operate in the running status that controller 420 is not stored).

Table 1 shows a variety of running statuses of equipment 100, especially, there is 8 kinds of running statuses herein, and corresponding The position of each volume control device 400.Controller 420 can in any other suitable format in storage table 1 running status (or, actually any desired running status), table format including but not limited to as follows.

Table 1：The running status of volume control device setting definition

As described above, each running status, which is each volume control device 400, specifies position, therefore, it is possible to open With or each above-mentioned fluid path of disabling.Some running statuses need not to the specific specified location of volume control device 400, Therefore allow those volume control devices 400 be maintained at before position.Flow is controlled to fill for example, fluid supplements running status The ad-hoc location for putting 400-6 and 400-7 is not required.Therefore, when the running status of equipment 100 from previous state switches to stream When body supplements running status, fluid control device 400-6 and 400-7 position will not change.

As described above, for example in the event of a power failure, volume control device 400 can not arrive precalculated position.Above-mentioned is urgent Failure running status shows the position during failure of each volume control device 400.In other words, it is urgent to fail running status not (although can with) be needed actively to be selected by the operator of controller 420 or equipment 100.On the contrary, promptly failure running status can be with Only powered off and activated by equipment 100.As above " urgent failure " state shown can be by the fail safe of volume control device 400 Position is activated automatically, or can be by Arbitrary Fault of the operator of equipment 100 for one or two component of reply equipment 100 Or the Arbitrary Fault that occurs in plant running and manual actuation, with the organ in protection equipment 100.

Before the operation in perfusion loop discussed further, the additional component of equipment 100 will first be described as follows.Especially, As described above, the equipment 100 in the present embodiment is arranged to transport and treat lung, therefore bushing is injected back into outside road, is also wrapped Include ventilating return.The part of ventilating return is shown in Fig. 6.Although eliminating perfusion loop in Fig. 6 in order to watch clear, It is evident that perfusion loop and ventilating return are included in equipment 100.

As a rule, ventilating return is configured as connection organ 104 and lung ventilator 600 (such as, in lower section), gas supply Gas, such as pure oxygen, air or similar are supplied in source 604 to lung ventilator 600.Lung ventilator 600 and gas supply source 604 are included in can Reuse in component 112, and by interface and gas conduit 608 (conduit 608-1,608-2 and 608-3 as depicted, The combination with any catheter of the exchanging gas of organ 104 can be used) it is connected.In the present embodiment, lung ventilator 600 and conduit Interface between 608 is provided by mechanical interface 328 and 408, is described when the connection in perfusion loop is discussed above. That is, interface 328 and 408 can be supported to irrigate the connection of loop and ventilating return.In further embodiments, can be one The mechanical interface of difference is provided on secondary property component 108 and reusable component 112 for perfusion loop and ventilating return.

Ventilating return include air bleeding valve 612 and flow sensor 616, flow sensor 616 can wirelessly or Wired mode is connected with controller 420.In certain embodiments, flow sensor 616 can use one or more Pitot tubes Realize.Further, ventilating return can include bronchoscopy interface 620, and bronchoscopy interface 620, which is connected to, leads Pipe 608-3 simultaneously allows to observe lung.Another side, conduit 608-3 is connected to trachea cannula to be connected to tracheae.Ventilating return One or more adjusting meanss (for example, wet heat exchanger) can also be included, the temperature of the gas for controlling to be transported to organ 104 Degree and moisture.In the present embodiment, these adjusting meanss are included in disposable assembly 108, because these adjusting meanss Generally all include disposable air filter.In further embodiments, particular adjustments device (for example, humidifier) is to weigh Use, therefore be placed in reusable component 112 again.

After the internal part for having described equipment 100, the operation of equipment 100 next will be introduced.At the beginning of Fig. 7 shows one kind The method 700 of beginningization and operational outfit 100.In block 702, organ 104 is placed in equipment 100.That is, working as organ 104 when being a lung or a pair of lungs, and lung is positioned on organ support 114, tracheae is connected into ventilating return, pulmonary artery and lung Connect of Vein to perfusion loop.Then protection dome 115 is placed on above lung.

In frame 705, perfusion loop is set to the fluid injection state as shown in above-mentioned table 1.As it was previously stated, running status Selection can be by control device in response to being received from input unit 424 specified running status input data and perform. In block 710, perfusion liquid is provided to perfusion loop by fluid injection port 340.It is readily apparent that in frame from Fig. 4 and table 1 The perfusion liquid provided in 710 flows into reservoir 300, then enters filter 334 and 332 by pump head 320, module 324.There is provided Perfusion liquid can also be from the direction inflow filter 334 and 332 in opposite direction with fluid proper flow (by conduit 308- 15th, 308-5 and 308-12), to ensure that filter 334 and 332 is filled completely.(in the present embodiment after the completion of perfusion liquid injection In there is provided about 2 liters of perfusion liquids, but the perfusion liquid of other volumes can also be provided, specific volume depends on the class of organ 104 Type and size), next method 700 performs frame 715.

In frame 715, perfusion loop is set to perfusion running status as shown in table 1.When equipment 100 includes ventilating back Lu Shi, such as in the present embodiment, ventilating return is also activated in frame 715.In addition, the also quilt in frame 715 of pump drive module 404 Activation.As a result, perfusion liquid flows to organ 104 from reservoir 300 through trandfer fluid path, and leaves organ 104 from outlet 316 Fluid through backwater fluid path return reservoir 300.

In frame 720, judge whether the perfusion liquid in more new equipment 100.In certain embodiments, (and the frame of frame 720 It can omit in 725 and 730, as described below).However, in the present embodiment, some Isolated lung perfusion schemes are considered predetermined Time interval remove and change specified quantitative perfusion liquid (for example 500 milliliters behind first hour of operation, per hour afterwards 250 milliliters).Any metabolic by-product that may be accumulated in reservoir can be diluted by updating perfusion liquid, and be supplemented in perfusion liquid Nutriment (particularly glucose) supply.Update perfusion liquid can also dilute in perfusion liquid hormonal compounds (for example, by The hormonal compounds that immunocyte in organ is produced).Do not wished if without dilution, these compounds may cause The inflammation of prestige.

When the judgement in frame 720 is "Yes", the execution of method 700 proceeds to frame 725, in frame 725, and perfusion loop is set Surely arrive fluid and remove state, until the perfusion liquid of required volume has been transferred in waste liquid device 304 (for example, being based on along waste liquor stream Flow velocity known to body path selects scheduled time length, or the operator based on equipment 100 is to the mesh of liquid level in waste liquid device 304 Survey to select scheduled time length).From table 1 (and Fig. 3 and Fig. 4) it is readily apparent that when performing frame 725, perfusion liquid From reservoir 300 is by organ 104 and flows back to the circulation of reservoir 300 and is continued for.

In frame 730, the perfusion liquid of predetermined is removed from reservoir 300 to after waste liquid device 304, equipment 100 is set It is set to fluid supplement running status, then further in the execution of frame 710, the perfusion liquid of corresponding volume passes through fluid injection port 340 are provided.In certain embodiments, set in frame 730 by fluid injection port 340 provide corresponding volume perfusion liquid with The volume that the perfusion liquid of waste liquid device 304 is flowed in frame 725 is equal.However, in further embodiments, than being removed in frame 725 The perfusion liquids of more or less volumes can be set supplement in frame 730.Then the execution of method 700 reaches frame again 715。

When the judgement in frame 720 is "No", it next be made whether to move fluid from organ support 114 in frame 735 Remove out the judgement of circulation.Under specific circumstances, for example equipment 100 run early stage, when other biological liquid (such as blood) more When being likely to be present in the runoff of the collection of organ support 114, it may be desirable to the removing fluids from organ support 114, rather than will Fluid circulation is into reservoir 300.When the judgement in frame 735 is "Yes", perfusion loop is set to when one selectable Between perform in section pallet liquid remove running status (within the time period, flow to the normal perfusion liquid circulation continuous of organ 104, Fluid flows to waste liquid device 304 from organ support leakage fluid dram, by mentioned above by conduit 308-18 and 308-20 connection organ The organ support waste liquid fluid path of support 114 and waste liquid device 304), pallet liquid is removed after the completion of running status, next perfusion Loop returns to the perfusion state of 715 frames.It is readily apparent that the judgement in frame 720 and 735 can cause and phase shown in Fig. 7 Anti- direction is performed.Similarly, the execution of frame 745 and 755 discussed below is carried out not necessarily in shown order.

When the judgement in frame 735 is "No", next it be made whether in frame 745 from a leucocyte filter (such as mistake Filter 332) it is switched to the judgement of another (such as filter 334).It is affirmative when judging, perfusion loop is set to standby filling Note state, in frame 750, standby perfusion state (as shown in table 1) redirects the flowing of perfusion liquid, turns from trandfer fluid path Standby trandfer fluid path is moved on to, the state of remaining fluid path keeps constant.When providing two leucocyte filters, such as exist In the present embodiment, the operation of equipment 100 is properly termed as including two stages：Using the first filter " ramping up " stage and Use " normal " stage of the second filter.

When the judgement in frame 745 is "No", it be made whether to terminate the judgement that equipment 100 is run in frame 755.Because equipment 100 arrived at the destination and organ 104 must prepare be used for be transplanted to by internal, then have to make as "Yes" in frame 755 Judgement.In other cases, the judgement of frame 755 can be end outside the plan, such as because of component failure, loses electric power or class Seemingly cause.When the judgement of frame 755 is "No", going in frame 715 for method 700 continues.When the judgement in frame 755 is "Yes", then the operation of equipment 100 will continue according to shown in Fig. 8.

Fig. 8 shows a kind of method 800 for terminating operational outfit 100.Depending on terminate be it is inside the plan (be not by failure Cause) or it is (being caused by the failure of equipment 100) outside the plan, and the execution of method 800 can be different.It is inside the plan when terminating When, such as after the destination being successfully transported to organ 104 where the subject patient to be implanted into, the purpose of end be The metabolic rate of reduction organ 104 carrys out armour 104 when subject patient prepares transplanting.

In frame 810, perfusion loop is arranged on done state as shown in table 1.As shown in table 1, under done state, Trandfer fluid path is blocked (filter 332 and 334 is all prevented from receiving perfusion liquid), and allows to irrigate all in loop Remaining perfusion liquid enters waste liquid device 304 via reservoir 300.In addition, the operation of pump controller 404 is also interrupted, ventilating return Can also be disabled (such as by closing lung ventilator 600 and closing tracheae 624 with clip or other suitable utensils).In frame During starting perfusion loop discharge opeing in 810, in frame 815, protection liquid is provided (preferably to perfusion loop by fluid injection port 340 Cooling protection liquid, such as Perfadex^TM)。

, can by the way that perfusion loop is back into perfusion state (so that starting pump controller 404) after protection liquid is introduced To recover the circulation of protection liquid in frame 820.In addition, the heat exchanger of module 324 can be switched to cooling work(from heating function Energy.For example, when organ 104 is a lung or a pair of lungs, it is desirable to which the temperature for protecting liquid is maintained at into about 10 degrees Celsius.It is aobvious and easy See, can be by repeating frame 810 but not performing frame 815 or 820 when subject patient gets out receive organ 104 To start final ending phase.

At the end of the operation of equipment 100 is in unplanned mode (such as due to power-off or unit failure), in frame 820, Irrigating loop can be failed by the input from operator or due to the invalid position of volume control device 400 in urgent State.In frame 830, as described in frame 815, protection liquid is supplied in perfusion loop.In frame 835, entrance 312 and outlet 316 are closed (such as with fixture or lid) to ensure to retain in organ 104 some protection liquid., can be with addition, in frame 840 Dome 115 is protected by protecting the lid (not shown) in dome 115 to be fed to outer protection liquid so that outside organ 104 Portion is surrounded by protection liquid at least in part.

Described above is the part of equipment 100 and operation, be described below some parts of equipment 100 structure and this The exemplary arrangement of a little parts.Reference picture 9, shows the illustrative embodiments of disposable assembly 108.As shown in figure 9, once Property component 108 include support organ 104 (on pallet, not shown) and carrying protect dome 115 housing 900.Housing 900 can With including the window 904 for allowing to observe reservoir 300 by it.In addition to the particular elements of disposable assembly 108, flowing control Device 400 processed is also shown as in fig .9, although as described above, they are preferably mounted in reusable component 112 (does not show Go out) in, to connect disposable assembly 108 when disposable assembly 108 is installed to reusable component 112.According to following attached Figure, it is obvious that volume control device 400 can be located at three surfaces 200-1,200-2 of reusable component 112 At 200-3.

Figure 10 A and 10B respectively illustrate the side view and front view of reservoir 300.As illustrated in figs. 10 a and 10b, reservoir 300 can the configuration based on the conduit 308 for being connected to reservoir 300 include multiple entrance and exits.In this example, reservoir 300 be made of flexible pouch (such as by any suitable plastics), and the reservoir 300 includes being connected to conduit 308-0 outlet 1004 and reservoir 300 is connected to the outlet 1008 of waste liquid device 304, i.e. in the embodiment in figure 10, conduit 308-0 quilts Two different conduit replacements).Reservoir 300 also includes being used for from fluid injection port 340 or organ support 114 (as shown in Figure 3) Receive the entrance 1012 of perfusion liquid.Entrance 1016 receives perfusion liquid by backwater fluid path (that is, from the backwater of organ 104).It is empty Gas escape orifice 1020 allows air to leave reservoir 300 during fluid injection.

Figure 11 shows volume control device 400-3 and 400-5 (at the surface 200-1 for being located at base 200) and flow Control device 400-6 and 400-7 (at the surface 200-3 for being located at base 200) arrangement.It also show reservoir 300, pump simultaneously First 320, leucocyte filter 332 and 334, fluid injection port 340 and mechanical interface 328.In the present embodiment, mechanical interface 328 Undertake the connection of module 324, ventilating return and pump head 320.

Figure 12 is another view of Figure 11 example shown components, and Figure 12 shows remaining volume control device 400.It is special Not, volume control device 400-1,400-2 and 400-4 shown in figure is located at the surface 200-2 of base 200, and flow control Device 400-8 processed is located at the surface 200-1 of base 200.The position of module 324 also figure 12 illustrates.

As shown in figure 13, it can be seen that fluid conduit systems 308 are from the part of disposable assembly 108 along disposable group The side wiring (detailed description and/or position on fluid conduit systems, refer to the description in Fig. 3) of part 108, can so permit Perhaps between imaging platform 1300 (such as x-ray plate) insertion organ 104 and the part.Therefore, positioned at the top of organ 104 (Figure 13 Shown orientation) imaging device can capture the image of organ 104, without the dry of the internal part by disposable assembly 108 Disturb.

The part of disposable assembly 108 may be arranged to improve the note of perfusion loop (frame 705 and 710 of such as method 700) Liquid efficiency.As shown in figure 14, the position of reservoir 300, pump head 320, leucocyte filter 332 and 334 and module 324 causes Hydrostatic gradient is produced, and from fluid injection port 340 (not shown, but as shown in previous figure, positioned at the top of organ 104) beginning, is prolonged Continue the entrance 1012 of reservoir 300, be then extended to reservoir 300 outlet 1004 and pump head 320 (on the He of entrance 1012 The description of outlet 1004, referring to Figure 10 B).Although physics upper module 324 is located at the top of pump head 320, by fluid injection port 340 The pressure of generation causes module 324 partially by the fluid injection of pump head 320.In addition, filter 332 and filter 334 and module 324 remainder can by above-mentioned filter fluid injection fluid path (i.e. conduit 308-15,308-12,308-5,308-13, 308-4 and 308-3, as shown in Figure 3) fluid injection.

In the arrangement being shown in the drawings, in injection process, pass through conduit 308-15,308-12 and 308-5 (such as Fig. 3 It is shown) flow to leucocyte filter 332 and the liquid stream of leucocyte filter 334 and may be not enough to fill the He of filter 332 completely Filter 334.In particular, the output port (it is used as input during fluid injection) of filter 332 and filter 334 may position In the bottom of filter 332 and filter 334, fluid injection may therefore can not be fully to filtering without enough fluid pressures Device 332 and the fluid injection of filter 334.Therefore, conduit 308-15,308-12 and 308-5 (as shown in Figure 3) is passed through in the present embodiment To filter 332 and the part fluid injection of filter 334.The fluid injection of filter 332 and filter 334 brings into operation it in pump head 320 After complete, with by conduit 308-3,308-4 and 308-13 it is (as shown in Figure 3) driving perfusion liquid enter filter 332 and 334. It will be apparent that in other arrangements, filter 332 and filter 334 can be arranged to by fluid from fluid injection port 340 Inject and flow through pipeline 308-15,308-12 and 308-5 (as shown in Figure 3) and by fully fluid injection.In further embodiments, The fluid injection of filter 332 and filter 334 can be realized by single filter outlet or single filter inlet.Example Such as, in certain embodiments, fluid from fluid injection port 340 can flow to filter by conduit 308-15 (as shown in Figure 3) 334 and 332 entrance (that is, the top of filter as shown in figure 14), rather than as shown in figure 3, via conduit 308-12 and 308-5 flow to the outlet of filter 332 and filter 334.

Further, in certain embodiments, the (not shown) of waste liquid device 304 is under the outlet 1008 of reservoir 300 Side, so that any fluid in perfusion loop under occurring power-off or other failures can be by force of gravity into waste liquid device.

In certain embodiments there is provided a kind of organ perfusion's equipment, including：Entrance and use for connecting the organ In the outlet for connecting the organ；Loop is irrigated, including：Fluid injection port, is configured to receive perfusion liquid；Reservoir, is configured to storage Deposit perfusion liquid；Multiple fluid conduit systems, for limiting：Connect the trandfer fluid path of the reservoir and the entrance；Connection institute The backwater fluid path of reservoir and the outlet is stated, the backwater fluid path is independently of the trandfer fluid path；Connection The fluid injection port and the fluid injection fluid path of the reservoir；The arrangement of the fluid injection port and the reservoir generate from Hydrostatic gradient of the fluid injection port to reservoir.

In certain embodiments, perfusion loop further comprises：Pump head module on the trandfer fluid path, is used In receiving the perfusion liquid from the reservoir；The pump head module and the arrangement of reservoir are generated from the reservoir to institute State the hydrostatic gradient of pump head module.

In certain embodiments, perfusion loop further comprises：The pump head module and institute on trandfer fluid path State the leucocyte filter between entrance；The for the filtering entrance that connects the pump head module and the leucocyte filter Second subgroup fluid of one subgroup fluid conduit systems and filtering outlet and the entrance for connecting the leucocyte filter is led Pipe；Wherein the multiple fluid conduit systems, which are further defined, connects the fluid injection port and the filter fluid injection of the filtering outlet Fluid path.

In certain embodiments, the filter fluid injection fluid path is limited by following part：Second subgroup fluid conduit systems Part conduit；And first injection catheter, first injection catheter connects the fluid injection port and the second subgroup fluid The part conduit of conduit.

In certain embodiments, perfusion loop further comprises：Volume control device, it has：Flow controls entrance, even The first injection catheter is connect, fluid is received from fluid injection port；First flow control outlet, is configured to trandfer fluid to the described second son The part conduit of group fluid conduit systems, and second flow control outlet, are configured to trandfer fluid and are led to yield in the second subset fluid Remaining conduit of pipe.

In certain embodiments, the volume control device has：First position, is configured to only to distribute a fluid to described First flow control outlet, for passing through the filter outlet to the leucocyte filter fluid injection；The second place, it is configured Only to distribute a fluid to second flow control outlet, for through the entrance to organ fluid injection；And the 3rd position, it is configured to Distribute a fluid to the first and second flows control outlet.

In certain embodiments, the fluid injection fluid path is independently of the filter fluid injection fluid path.

In certain embodiments, the fluid injection fluid path is by the connection fluid injection port and the second note of the reservoir Fluid catheter is limited.

In certain embodiments, perfusion loop further comprises：The pump head mould on the trandfer fluid path Adjustment module between block and the entrance, for receiving the perfusion liquid from the pump head module.

In certain embodiments, the adjustment module is located between the pump head module and the leucocyte filter.

In certain embodiments, the arrangement of the leucocyte filter and the adjustment module is generated from the fluid injection end Mouth arrives the leucocyte filter, to the hydrostatic gradient of the control module.

In certain embodiments there is provided a kind of method for running organ perfusion equipment, including：Organ is connected to perfusion Loop, the perfusion loop has：Fluid injection port；Reservoir；Waste liquid device；Multiple fluid conduit systems, for limiting：The connection note Liquid port and the fluid injection fluid path of the reservoir；The backwater fluid path that the reservoir is exported with the organ is connected, The backwater fluid path is independently of the trandfer fluid path；And the waste liquor stream of the connection reservoir and the waste liquid device Body path；Multiple volume control devices are controlled, the multiple control device is configured to optionally prevent or allows fluid every Flowed under individual running status through fluid conduit systems, the control includes：One fluid injection running status of setting is noted with allowing fluid to pass through Liquid fluid path；In response to the fluid injection running status of setting, perfusion liquid is supplied through fluid injection port and fluid injection fluid path To reservoir；Setting one irrigates running status to allow perfusion liquid through trandfer fluid path, organ fluid path and backwater stream Body path is circulated, while preventing fluid from passing through fluid injection fluid path and waste liquid fluid path；Running status is irrigated setting Afterwards, fluid is set to remove running status to allow fluid to flow to waste liquid device through waste liquid fluid path.

In certain embodiments, methods described further comprises：Perfusion liquid in response to predetermined is removed from reservoir To waste liquid device, setting supplement running status allows fluid through fluid injection fluid path, so as to reservoir supplement in addition Predetermined perfusion liquid.

In certain embodiments, supplement running status further allows perfusion liquid through trandfer fluid path, organ fluid road Footpath and the circulation of backwater fluid path, while preventing fluid through waste liquid fluid path.

In certain embodiments, installing organ includes organ being connected to each entrance and exit.

In certain embodiments, the organ can be lung；And the organ is connected to the entrance including that will enter Mouth is connected to the pulmonary artery of organ；Organ is connected into outlet includes that the pulmonary vein for being connected to organ will be exported.

In certain embodiments, the multiple fluid conduit systems, which are further defined, connects the reservoir and the entrance Standby trandfer fluid path；The control further comprises：Standby perfusion state is set to allow perfusion liquid through standby transport Stream Body path, organ fluid path and the circulation of backwater fluid path, while preventing fluid through fluid injection fluid path and waste liquid fluid road Flow in footpath.

In certain embodiments, the multiple fluid conduit systems are further limited：Connect the organ support and the liquid storage The organ support backwater fluid path of device, and connect the organ support waste liquid fluid road of the leakage fluid dram and the waste liquid device Footpath；The control further comprises：Setting organ support fluid removes running status and given up with allowing perfusion liquid to flow through organ support Liquid fluid path, while preventing fluid through organ support backwater fluid path.

In certain embodiments, setting perfusion running status includes starting the pump on trandfer fluid path.

In certain embodiments, methods described further comprises that setting terminates running status to allow fluid to flow through backwater stream Body path and waste liquid fluid path, while preventing fluid from being flowed through trandfer fluid path.

In certain embodiments, methods described further comprises：In response to perfusion liquid is discharged into waste liquid device from organ, lead to Fluid injection port is crossed to organ supply protection liquid.

In certain embodiments, methods described further comprises closing the outlet and the entrance.

In certain embodiments, methods described further comprises the extra protection liquid of organotropic outside supply.

There is provided a kind of method for terminating the operation of organ perfusion equipment in certain embodiments.Methods described includes：Stop Circulation of the perfusion liquid in the perfusion loop of organ is connected to by entrance and exit；Perfusion liquid is discharged to waste liquid from organ Device；And by fluid injection port to organ provide protection liquid.

In certain embodiments, the method for terminating the operation of organ perfusion equipment further comprises closing outlet and entrance.

In certain embodiments, the method for terminating the operation of organ perfusion equipment further comprises supplying extra guarantor to organ Protect liquid.

The scope of claims should not be limited by the specific embodiment illustrated in above-described embodiment, and should be assigned Give with entire description consistent broadest explanation.

Claims (16)

1. a kind of organ perfusion's equipment, it is characterised in that including：

For connecting the entrance of the organ and outlet for connecting the organ；

Loop is irrigated, including：

Reservoir, is configured to store perfusion liquid；

Waste liquid device；

Multiple fluid conduit systems, for limiting：

Trandfer fluid path, the trandfer fluid path connects the reservoir and the entrance；

Backwater fluid path, the backwater fluid path independently of the trandfer fluid path, connect the reservoir with it is described Outlet；

Waste liquid fluid path, the waste liquid fluid path connects the reservoir and the waste liquid device；

First flow control device, is configured to optionally prevent or allows fluid via the trandfer fluid path from the storage Liquid device flows to the organ；And

Second flow control device, is configured to optionally prevent or allows fluid via the waste liquid fluid path from the storage Liquid device flows to the waste liquid device.

2. perfusion equipment according to claim 1, it is characterised in that the perfusion loop further comprises：

The reservoir fluid injection fluid path limited by the multiple fluid conduit systems, the reservoir fluid injection fluid path connects one Fluid injection port and the reservoir.

3. perfusion equipment according to claim 2, it is characterised in that the perfusion loop further comprises：

The organ fluid injection fluid path limited by the multiple fluid conduit systems, the organ fluid injection fluid path connects the fluid injection Port and the organ；

3rd volume control device, be configured to optionally prevent or allow fluid via the reservoir fluid injection fluid path and At least one in organ fluid injection fluid path flows out from the fluid injection port.

4. perfusion equipment according to claim 1, it is characterised in that the perfusion loop further comprises：

Pump head module on the trandfer fluid path, for receiving the perfusion liquid from the reservoir；

Adjustment module on the trandfer fluid path, for receiving the perfusion liquid from the pump head module；

Leucocyte filter on the trandfer fluid path, for receiving perfusion liquid from the adjustment module；Described One volume control device is arranged between the pump head module and the leucocyte filter.

5. perfusion equipment according to claim 4, it is characterised in that the perfusion loop further comprises the second leucocyte Filter；

The standby trandfer fluid path further limited by the multiple fluid conduit systems, the standby trandfer fluid path is via institute State the second leucocyte filter and connect the holder reservoir and the entrance；

The perfusion equipment further comprises the 3rd volume control device, and the 3rd control device is configured to optionally prevent Or allow fluid to be flowed via the standby trandfer fluid path.

6. perfusion equipment according to claim 1, it is characterised in that further comprise：

Organ support；

Leakage fluid dram in the organ support；

The organ support backwater fluid path further limited by the multiple fluid conduit systems, the organ support backwater fluid road Footpath connects the leakage fluid dram and the reservoir.

7. perfusion equipment according to claim 6, it is characterised in that the multiple fluid conduit systems further define organ Support waste liquid fluid path, the organ support waste liquid fluid path connects the leakage fluid dram and the waste liquid device；

The perfusion equipment further comprises the 3rd volume control device, and the 3rd control device is configured to optionally prevent Or allow fluid via the organ support waste liquid fluid path.

8. perfusion equipment according to claim 1, it is characterised in that further comprise：

Controller, the controller stores multiple running statuses, and each running status determines each volume control device Position, and the controller is configured to be communicated with each in the volume control device；

Sensor, is configured to produce the measurement of the characteristic of the perfusion liquid；

The controller is further configured to receive the measurement, and a running status is automatically selected according to the measurement, And the volume control device is controlled based on selected running status.

9. perfusion equipment according to claim 8, it is characterised in that further comprise the input for being connected to the controller Device；

The controller is further configured to receive a selected running status from the input equipment, and based on quilt The running status of selection controls the volume control device.

10. perfusion equipment according to claim 1, it is characterised in that the first flow control device and described second Volume control device has a failure state, and the failure state is configured to allow fluid via the waste liquid fluid path from described Reservoir flow to the waste liquid device.

11. perfusion equipment according to claim 1, it is characterised in that the multiple fluid conduit systems further define standby Backwater fluid path is used, the standby backwater fluid path connects the reservoir and the outlet；

The perfusion loop further comprises：

Pressure-control valve on the backwater fluid path；And

3rd volume control device, the 3rd volume control device is configured to optionally guide fluid through the backwater fluid A flow path in path and the standby backwater fluid path.

12. perfusion equipment according to claim 1, it is characterised in that further comprise：

Disposable assembly, including：

The entrance；

The outlet；

The multiple fluid conduit systems in the reservoir, the waste liquid device, and the perfusion loop；And

Reusable component, including：

Base, is configured to detachably support the disposable assembly under operation；

The first flow control device；And

The second flow control device；

When the disposable assembly is supported by the base, the first flow control device and second flow control dress Put and be respectively configured as optionally preventing or allow fluid via the trandfer fluid path and the waste liquid fluid path.

13. perfusion equipment according to claim 12, it is characterised in that the base includes being used to support described disposable The wall of component；

Wherein described first flow control device and the second flow control device are used by the reusable modular support To connect the fluid conduit systems of the neighbouring wall.

14. perfusion equipment according to claim 12, it is characterised in that the disposable assembly further comprises that gas is led Pipe, the gas conduit is connected to gas access to be connected to the organ；The reusable component further comprises exhaling Suction machine；

The disposable assembly and the reusable component include can supporting machinery interface, it is described can supporting machinery interface match somebody with somebody It is set to the connection lung ventilator and the gas conduit.

15. perfusion equipment according to claim 14, it is characterised in that the disposable assembly further comprises being located at institute The pump head module on trandfer fluid path is stated, for receiving the perfusion liquid from the reservoir；

The reusable component further comprises pump drive module, and the pump drive module is used to drive the pump head mould Block；

The pump drive module and the pump head module can the connection operations of supporting machinery interface described in.

16. perfusion equipment according to claim 12, it is characterised in that the disposable assembly further comprises being located at institute The adjustment module on trandfer fluid path is stated, the adjustment module includes heat exchanger and gas exchanger；And

The reusable component further comprises：

Heater, is configured to the fluid after heating being transported to the heat exchanger；And

Gas storage device, is configured to deliver gas to the gas exchanger.