JP2013221524A - カセットシステム統合型装置 - Google Patents
カセットシステム統合型装置 Download PDFInfo
- Publication number
- JP2013221524A JP2013221524A JP2013105453A JP2013105453A JP2013221524A JP 2013221524 A JP2013221524 A JP 2013221524A JP 2013105453 A JP2013105453 A JP 2013105453A JP 2013105453 A JP2013105453 A JP 2013105453A JP 2013221524 A JP2013221524 A JP 2013221524A
- Authority
- JP
- Japan
- Prior art keywords
- fluid
- cassette
- pump
- membrane
- valve
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000012530 fluid Substances 0.000 claims abstract description 833
- 238000005086 pumping Methods 0.000 claims abstract description 88
- 238000004891 communication Methods 0.000 claims abstract description 69
- 238000006073 displacement reaction Methods 0.000 claims abstract description 45
- 239000012528 membrane Substances 0.000 claims description 363
- 238000010586 diagram Methods 0.000 description 58
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- 238000000034 method Methods 0.000 description 24
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 21
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 18
- 238000003860 storage Methods 0.000 description 17
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
- 210000004027 cell Anatomy 0.000 description 13
- 239000000463 material Substances 0.000 description 13
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 12
- 230000008878 coupling Effects 0.000 description 12
- 238000010168 coupling process Methods 0.000 description 12
- 238000005859 coupling reaction Methods 0.000 description 12
- 239000000243 solution Substances 0.000 description 12
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- 238000001631 haemodialysis Methods 0.000 description 9
- 230000000322 hemodialysis Effects 0.000 description 9
- 238000005259 measurement Methods 0.000 description 9
- 235000017557 sodium bicarbonate Nutrition 0.000 description 9
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 9
- 239000011780 sodium chloride Substances 0.000 description 8
- 238000013461 design Methods 0.000 description 6
- 239000000203 mixture Substances 0.000 description 6
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 6
- 239000000843 powder Substances 0.000 description 6
- 239000000523 sample Substances 0.000 description 6
- 229910001220 stainless steel Inorganic materials 0.000 description 6
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- 230000008901 benefit Effects 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- 230000037361 pathway Effects 0.000 description 5
- 238000007789 sealing Methods 0.000 description 5
- CCEKAJIANROZEO-UHFFFAOYSA-N sulfluramid Chemical group CCNS(=O)(=O)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F CCEKAJIANROZEO-UHFFFAOYSA-N 0.000 description 5
- 238000003466 welding Methods 0.000 description 5
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- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical group [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 3
- 210000001124 body fluid Anatomy 0.000 description 3
- 239000010839 body fluid Substances 0.000 description 3
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- 229910002804 graphite Inorganic materials 0.000 description 3
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- 229910052697 platinum Inorganic materials 0.000 description 3
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- 241001325256 Ellisia nyctelea Species 0.000 description 2
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- 230000000903 blocking effect Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
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- 238000012545 processing Methods 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 229920002943 EPDM rubber Polymers 0.000 description 1
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
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- 239000000356 contaminant Substances 0.000 description 1
- 238000011217 control strategy Methods 0.000 description 1
- 238000002788 crimping Methods 0.000 description 1
- 235000015872 dietary supplement Nutrition 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 235000012041 food component Nutrition 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 150000002484 inorganic compounds Chemical class 0.000 description 1
- 229910010272 inorganic material Inorganic materials 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
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- 150000002825 nitriles Chemical class 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 238000011017 operating method Methods 0.000 description 1
- 150000002894 organic compounds Chemical class 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 230000001151 other effect Effects 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 229920002492 poly(sulfone) Polymers 0.000 description 1
- 239000000047 product Substances 0.000 description 1
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- 229920005989 resin Polymers 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 230000035939 shock Effects 0.000 description 1
- XHFLOLLMZOTPSM-UHFFFAOYSA-M sodium;hydrogen carbonate;hydrate Chemical compound [OH-].[Na+].OC(O)=O XHFLOLLMZOTPSM-UHFFFAOYSA-M 0.000 description 1
- 230000000153 supplemental effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 229920001187 thermosetting polymer Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 210000000635 valve cell Anatomy 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
Classifications
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/02—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms
- F04B43/025—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms two or more plate-like pumping members in parallel
- F04B43/026—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms two or more plate-like pumping members in parallel each plate-like pumping flexible member working in its own pumping chamber
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/154—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit with sensing means or components thereof
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/155—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit with treatment-fluid pumping means or components thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
- A61M1/1561—Constructional details of the cassette, e.g. specific details on material or shape at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
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- A—HUMAN NECESSITIES
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
- A61M1/1562—Details of incorporated reservoirs
- A61M1/15625—Details of incorporated reservoirs the reservoirs acting as balance chambers
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1603—Regulation parameters
- A61M1/1605—Physical characteristics of the dialysate fluid
-
- A—HUMAN NECESSITIES
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
- A61M1/1635—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid
- A61M1/1639—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid linked by membranes
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
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- A61M1/166—Heating
- A61M1/1664—Heating with temperature control
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
- A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
- A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
- A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
- A61M60/37—Haemodialysis, haemofiltration or diafiltration
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/424—Details relating to driving for positive displacement blood pumps
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- A61M60/80—Constructional details other than related to driving
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/845—Constructional details other than related to driving of extracorporeal blood pumps
- A61M60/847—Constructional details other than related to driving of extracorporeal blood pumps arranged in a cassette
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Abstract
【解決手段】 ポンピングカセットは、少なくとも2つの流入口流路及び少なくとも2つの排出口流路を含むハウジングと、ハウジング内に位置され流体ラインと流体連通されることにより第1流体の量と第2流体の量が同一になるように第1流体の流動と第2流体の流動のバランスを取る少なくとも1つのバランスポッドと、ハウジング内で圧力ポンプが流入口流体ラインから排出口流体ラインへと第1流体を汲み出し、且つ、流入口流体ラインから排出口流体ラインまで前記第2流体を汲み出す少なくとも1つの往復運動型圧力変位膜ポンプとを備える。バランスポッドは、二つのバランス室を形成する膜を含む。
【選択図】 図800B
Description
本願は、2007年10月12日に出願した「目的の装置のためのカセットシステム(Cassette System Integrated Apparatus)」(代理人整理番号 No. DEKA−023XX)と題される米国特許出願第11/871,803号明細書の部分継続出願であり、2007年2月27日付で出願された「血液透析システム及びその方法(Hemodialysis System and Methods)」と題される米国仮明細書特許出願第60/904,024号明細書及び2007年4月2日付で出願された「センサ装置(Sensor Apparatus)」と題される米国仮明細書特許出願第60/921,314号明細書を基礎として優先権を主張し、上記した特許出願はすべて、その全体が本願明細書に参照により援用される。
ポンピングカセットの一態様によれば、カセットは、少なくとも2つの流入口流路及び少なくとも2つの排出口流路を含むハウジングを含むカセットである。少なくとも1つのバランスポッドがハウジング内に位置され、流体経路と流体連通される。バランスポッドは、第1流体の流動と第2流体の流動の均衡を維持することにより、第1流体の量が第2流体の量と等しくなるようにする。また、バランスポッドは、二つのバランスカセットを形成する膜を含む。また、カセットには、少なくとも2つの往復運動型圧力変位膜ポンプが設けられる。ポンプは、ハウジング内に配置され、また、ポンプは、流体流入口から流体排出口ラインへと流体を汲み出し、また流体流入口から流体排出口まで第2流体を汲み出す。
1.ポンピングカセット
1.1 カセット
ポンピングカセットは種々の特徴、例えば、ポッドポンプ、流路、そして、いくつかの実施形態では弁を含む。この説明で図示して説明されるカセットの実施形態は、例示的ないくつかの代替の実施形態を含む。しかしながら、カセットの任意の改変が同様の機能を有することを意図している。また、ここで説明されるカセットの実施形態は、図8A及び図8Bに示される流体の概略図の実施例である。他の実施形態では、カセットは、多様の流体経路、多様な弁の配置、及び多様なポッドポンプの配置のうち少なくとも何れか1つ、並びに多様の数を有するものが本発明の範囲内にある。
図1は、カセットの例示的実施形態に従って、流体制御又はポンプカセット(図3及び図4も参照)に組み込まれた例示的なポッドポンプ100を示す断面図である。この実施形態において、ポッドポンプは、三つの硬質な部品、即ち、「天」板106、中板108、及び「低」板110から形成される(用語「天」及び「底」は相対的なものであり、図1で示される向きを参照して便宜上ここで使用されていることを留意されたい。)。天板及び底板106,110は、概して半球状の部分を含む。一緒に組みつけられたとき、半球状の部分は、ポッドポンプ100である半球状の室を形成する。
図1Bには、バランスポッドの例示的実施形態が示されている。このバランスポッドは、図1Aを参照して上記したポッドポンプとほぼ同様に構成されている。しかしながら、バランスポッドは、作動室及びポンプ室の代わりに、二つの流体バランス室を含み、作動ポートを有していない。更に、各バランス室は、吸入口102と排出口104とを備えている。この例示的実施形態において、各バランス室壁120,122には、溝126がそれぞれ形成されている。溝126については、後でより詳細に説明する。
この定量ポンプは、任意の流体を供給又は排出可能な任意のポンプであってもよい。この流体は、医薬品、無機化合物又は無機成分、有機化合物又は有機成分、栄養補給食品、栄養成分、栄養化合物又は栄養溶液、或いはポンプによって汲み出し可能な他の任意の流体を含み、これらに限らない。一実施形態において、定量ポンプは膜ポンプである。例示的実施形態において、定量ポンプは、容積がより小さいポッドポンプである。この例示的実施形態において、比較的に大きいポッドポンプ(例えば図1Aに示されるように)と同様に、吸入口と排出口とを備えている。しかしながら、ポッドポンプと比較して、それらの吸入口及び排出口は、一般的に遥かに小さいものである。例示的な一実施形態において、各吸入口及び排出口の周りには、火山形状の弁のような***リングが形成されている。定量ポンプは、膜を備えている。図5E〜5Hには、定量ポンプの膜の様々な実施形態が示されている。一実施形態では、定量ポンプは、所定量の流体を流路の外部に汲み出す。流体がポッドポンプ内にあると、カセットの外部に位置する基準室は、FMSにより排出された容量を測定する。
カセットの例示的実施形態では、一つ以上の弁を備えている。弁は、流路を連通又は遮断することにより、流れを調整するように使用されている。カセットの多数の実施形態に含まれる弁は、一つ以上の火山形状の弁又は滑らかな形状の弁を含んでいる。カセットの所定の実施形態において、チェック弁を含んでもよい。図2A及び2Bには、火山形状の弁の実施形態が示され、図2Cには、円滑型弁の実施形態が示されている。更に、図3A〜4Bは、吸入口及び排出口を有するカセットにおけるポッドポンプの例示的実施形態を示している。
図4に示されるように、一実施形態において、膜は、変化する断面の厚さを有する。より薄い、より厚い、又は変化する膜は、選択された膜の材料の強度、屈曲特性又は他の特性に適用するために使用されることが可能である。より薄い、より厚い、又は厚さが変化する膜壁は、膜の制御のために採用されることもある。これにより、膜が所定の領域において、他の領域と比較してより湾曲しやすいことを促進し、ポンプの駆動及びポンプ室における主流体の流れの制御に有利である。この実施形態において、膜の断面が最も厚い部分は、膜の中心部にある。しかしながら、変化する断面を有する他の実施形態においては、最も厚い部分及び最も薄い部分は、膜の任意部分に位置してもよい。従って、例えば、比較的に薄い断面は中心の近くに位置し、比較的に厚い断面は膜の周囲の近くに位置してもよい。また、他の構造も可能である。図5A〜5Dには、異なる態様の表面を有する膜の実施形態が示されている。これらの表面は、膜の作動側及び汲み出し側のうち少なくとも一方の異なる部分に位置する、異なる厚さ及び形状のうち少なくとも一方の円滑面(図5A)、リング(図5D)、リブ(図5C)、くぼみ又はドット(図5B)を含んでいる。膜の一実施形態において、膜は、少なくとも一つの断面において正接の勾配を有するが、他の実施形態において、膜は完全に円滑、或いは実質的に円滑である。
主流体に対して所望の耐久性及び適合性を有する任意の可撓性材料によって膜を形成することが可能である。作動室に供給される流体、液体又は気圧又は真空に応じて湾曲することのできる任意の材料によって膜を形成することができる。膜の動作を促進するために、膜の材料は、生物適合性、温度適合性、又は膜によってそれらの室に汲み出し或いは導入される様々な流体との適合性により選択されてもよい。その例示的実施形態では、膜は高伸張シリコンによって形成されている。しかしながら、他の実施形態においては、膜は、シリコン、ウレタン、ニトリル、EPDM(これらに限定されない)を含む任意のエラストマー、ゴム、又は他のゴム、エラストマー或いは可撓性材料によって形成されている。
カセットの一実施形態は、混合ポッドを備えている。混合ポッドは、混合のための室を有している。一実施形態において、混合ポッドが可撓性構造であり、一実施形態において、混合ポッドの少なくとも一部が可撓性構造である。混合ポッドは、Oリング等のシール、又は膜を備えることができる。この混合ポッドは、所望の任意形状を有することができる。例示的実施形態において、混合ポッドは、膜及び作動ポートを有しないことを除いて、ポッドポンプと同様である。この混合ポッドの一実施形態では、混合ポッド室をシールするためのOリングシールを備えている。従って、例示的実施形態においては、混合ポッドは、流体吸入口及び流体排出口を備える球状の中空のポッドである。ポッドポンプと同様に、室は所望の任意サイズを有することができる。
図7は、負圧及び正圧の双方によりポッドポンプ(例えば図1Aに示されるポッドポンプ)を駆動可能な圧力ポンプ作動システムの一実施形態を示す図である。この圧力作動システムは、正圧及び負圧を間欠的に又は交互に、ポッドポンプの作動室における気体に印加することができる。しかしながら、一実施形態(図7はこれらの実施形態を示さない)において、ポッドポンプは、正圧及び大気への通気を印加している。このポッドポンプ(可撓性膜、吸入口、排出口、空気圧ポート、ポンプ室、作動室を含み、或いは流入チェック弁及び流出チェック弁、又は他の弁を含む)は、大きな使い捨てのシステムの一部である。その空気作動システム(作動室圧力変換器、正圧供給弁、負圧供給弁、正圧ガス容器、負圧ガス容器、正圧容器の圧力変換器、負圧容器の圧力変換器、及び電子制御装置(一実施形態では、ユーザインターフェースコンソール、例えばタッチパネル画面を含む)を備える)は、基本単位の一部であってもよい。
図2A〜図2Dに示すように、例示的実施形態の流体弁は可撓性膜を備えた小さな室を備え、膜は室を中央付近で流体側と空気圧側に二分している。この例示的実施形態の流体弁は三つの吸入/排出ポートを有し、そのうちの二つは室の流体側に、残りは空気圧側に設けられている。室の空気圧側に設けられたポートは室に対し正圧又は真空を印加可能である(いくつかの実施形態では、真空ではなく大気を導入する)。室の空気圧部分に真空が印加されると、膜は気体側に引き込まれ、流体経路を開放する。これにより、流体が室の空気圧側に流入あるいは流体側から流出することが可能になる。室の空気圧部分に正圧が印加されると、膜は室の流体側に向かって押圧され、流体経路を塞ぎ、流体の流れを止める。流体ポートの一つに設けられた火山形状の弁の実施形態(図2A,2Bに示す)において、このポートは閉弁の際にまず密閉し、弁の中に残っている流体は火山形状の部分を使わずにポートから排出される。加えて、図2Dに記載の実施形態の弁では、二つのポートの間に設けられた***部分が、作動ストロークの早い段階で(すなわち膜がポートを直接的に密封するより前に)二つのポートを互いに対して密閉することを可能にする。
4.容量の計測
カセット内の流速はストローク端を検知可能な圧力ポッドポンプにより制御される。外部制御ループにより、必要な流れを発生させるための正確な圧力値が決定される。圧力ポンプは、各ストロークの完了を検出するためのストローク端アルゴリズムを実行可能である。膜が動いている間、室内の計測圧力は所望の正弦波圧力となる。膜が室の壁面に接触すると、正弦波に沿った変化をやめ、圧力は一定になる。圧力信号のこの変化がストロークの終わり、つまり、ストローク端を検出するのに使われる。
5.混合カセットの例示的な実施形態
用語の流入口及び排出口、及び第1流体、第2流体、第3流体、並びに弁経路(すなわち、“第1の弁経路”)に与えられた指定数字は、単に説明するために使用されたものである。他の実施形態において、流入口は、排出口となり得るとともに、第1、第2、第3という指定は、それらの流体が互いに異なる流体であること、或いは、特に体系的に分類されていることを意味するものではない。そのような指定は、ただカセット内への区分された入口領域を単純に示すものであって、第1、第2、第3、その他の流体は、互いに異なる流体であってもよく、又は同一の流体タイプであってもよく、或いは、その組み合わせであるか、少なくとも2つが同一のものであってもよい。第1、第2、第3、その他の指定と同様に、それらの弁経路は、何ら特別な意味を有するものではなく、明確な説明のために使用されたものである。
図13A−13Bを参照すると、低板1300が示されている。先ず、図13Aを参照すると、低板1300の内側又は内部表面が示されている。内側又は内部表面は、中板(図示省略、図9Bを参照)の底面と接触する側部である。低板1300は、空気又は作動ライン(図示省略)に取り付けられている。中板1200内の弁(図示省略、図10A−10Fを参照)及びポッドポンプ820、828を作動させる空気のための対応の入口ホールが示されている。ホール810、824は、図12Bにそれぞれ示された第1の流体流入口及び第1の流体排出口810、824に対応する。混合室818及びポッドポンプ820、828の対応する半分部も同じく示されており、流体経路のための溝1002等も示されている。また、ポンプ内の作動ホールも示されている。天板とは異なって、混合室818及びポッドポンプ820、828の半分部に対応する低板1300は、混合室818とポッドポンプ820、828の間の差異を明確にする。ポッドポンプ820、828は、低板1300の上の空気/作動経路を含むが、それに対して、混合室818は、天板内の半分部と同様の構成を含む。混合室818は、液体を混合し、それによって、膜(図示省略)を含まず、また空気/作動経路も含んでいない。センサセル1314、1316が、センサ要素ハウジング1308、1310、1312及び1318、1320、1322と共に示されている。
5.1 膜
例示的な実施形態において、膜は、図5Aに示されているようにガスケットO−リング膜である。さらに、いくつかの実施形態において、ガスケットO−リング膜は、テクスチャーを含むことができるが、それに制限されるものではなく、図4D又は図5B−5Dの様々な実施形態が使用されることも可能である。また他の実施形態において、図6A−6Gに示されている膜が使用されることも可能である。
5.2 断面図
図15A−15Cを参照すると、組み立てられたカセットの様々な断面が示されている。先ず、図15Aを参照すると、膜1602は、ポッドポンプ820、828内に示されている。断面図から確認されるように、膜1602のO−リングは、中板1200と低板1300とによって挟持されている。弁膜1606も、また確認することができる。上記したように、それぞれの弁は膜を含む。
図19Aを参照すると、組み立てられたカセット1900の他の実施形態が示されている。図19C−19Dは、カセット1900の例示的な実施形態の分解組立図であり、ここに、ポッドポンプ膜1910と、弁膜1914と、定量ポンプ膜1912とが示されている。3個の定量ポンプ1616、1618、1620だけではなく、それぞれの膜1912も示されている。この実施形態において、3個の流体を定量することが可能であり、さらに、それぞれの制御された量が、混合室1622、1624内で一緒に混合することが可能である。図20A及び20Bは、組み立てられたカセット1900の断面図を示している。
5.3 混合カセットの例示的な実施形態
実際に、カセットは、任意のソースから任意の位置に、任意のタイプの流体を汲み出すために使用することができる。この流体のタイプには、栄養的な、非栄養的な、無機化学物質、有機化学物質、体液又は他のあらゆるいずれかのタイプの流体が含まれる。また、いくつかの実施形態において、流体はガスを含み、したがって、いくつかの実施形態において、カセットは、ガスを汲み出すために使用される。
の弁であってもよい。
6.中間カセットの例示的な実施形態
図38Aを参照すると、ポンピングカセット3800の流体配線図の例示的な実施形態が示されている。他の配線図も容易に識別することができ、配線図の1つの代替的な実施形態が図38Aに示されている。図38Aを参照すると、カセット3800は、少なくとも1つのポッドポンプ3820、3828と、少なくとも1つの通気口3830とを含む。また、カセット3800は、少なくとも1つの流体ポートを含む。この配線図において、複数のポート3804、3810、3824、3826、3830、3832、3846、3848、3850、3852、3854が示されている。さらに、代替的な実施形態において、ポートの数及び/又は位置は、それと異なっていてもよい。複数のポートのオプションは、任意の機能のための、任意のタイプの流体に関する数多くの汲み出し用配線図を提供することができる。
一実施形態において、1つ以上のポート3804、3810、3824、3826、3830、3832、3846、3848、3850、3852、3854が、カセットの外部に汲み出される流体のためのフィルタ又は他の処理領域に取り付けられている。いくつかの実施形態において、ポッドポンプ3820、3828は、フィルタ又は他の処理領域を介して流体を押し出すほどの十分な汲み出し力を提供する。
図310A及び310Bを参照すると、中板31000の流体/液体側部が示されている。図39C及び39Dに示された内側天板の上の流体経路に関する相補的な領域が示されている。これらの領域は、例示的な実施形態において、1つの製造モードであるレーザー溶接に対して伝導性を含む表面仕上げを示す、わずかに高くなったトラックである。カセットの他の製造モードに対しては、既に以上で説明した。図310A及び310Bを参照すると、カセットの例示的な実施形態のポートは、図38Aに関して示されて説明した配線図に対応してラベル付けされている。1つのポート、すなわち、ポート3852にはラベルが付けられていない。このポートは、図39Cにもっともよく示されている。
6.1 中間カセットの例示的な実施形態
実際に、カセットは、任意のタイプの流体を任意のソースから任意の位置に汲み出すために、使用することができる。この流体のタイプには、栄養的な、非栄養的な、無機化学物質、有機化学物質、体液又は他のあらゆるいずれかのタイプの流体が含まれる。また、いくつかの実施形態において、流体はガスを含み、したがって、いくつかの実施形態において、カセットは、ガスを汲み出すために使用される。
7.バランシングカセットの例示的な実施形態
図448Aを参照すると、定量カセット4800及びバランシングポンプの流体配線図の例示的な実施形態が示されている。他の配線図も、容易に識別される。カセット4800は、少なくとも1つのポッドポンプ4828、4820、及び、少なくとも1つのバランシングポッド4822、4812を含む。カセット4800は、また第1の流体流入口4810を含み、そこで第1流体は、カセット内に流入される。第1流体は、カセット4800の外部に提供される流量を含む。カセット4800は、さらに第1の流体排出口4824を含み、第1の流体排出口で、第1流体は少なくとも1つのポッドポンプ4828のうちのいずれかによって提供される流量でカセット4800から抜け出る。カセット4800は、第2流体がカセット4800に流入される第2の流体流入口4826と、第2流体がカセットを抜け出る第2の流体排出口4816とを含む。
代替的な実施形態において、カセット内にセンサがなくてもよく、又は温度センサのみが、1つ以上の伝導性センサのみが、又は1つ以上の他のタイプのセンサが存在してもよい。
7.1 膜
例示的な実施形態において、膜は、図6Aに示すようなダブルOリング膜である。しかし、いくつかの実施形態において、非制限的な例であって、図6B乃至図6Fのいくつかの実施形態を含み、テクスチャーを含むダブルOリング膜が用いられてもよい。
7.2 断面図
図413A乃至図413Cを参照すると、組み立てられたカセットのいくつかの断面が示されている。図413Aを先ず参照すると、膜41220が、バランスポッド4812及びポッドポンプ4828内に示されている。断面図から分かるように、膜41220のダブルOリングが、中板4900、低板41100、及び天板41000間に挟持される。
図417A及び図417Bを参照すると、カセット41700の組み立てられた代替的な実施形態が示されている。図417C及び図417Dは、カセット41700の分解組立図である。図417Eは、カセット41700の断面図である。
7.3 バランスカセットの例示的な実施形態
ポンピングカセットは、多くの分野において用いられ得る。しかし、例示的な実施形態において、ポンピングカセットは、第1流体流入口に入り、第1流体排出口から抜け出す流体と、第2流体流入口からカセット内に流入され、第2流体排出口からカセットを抜け出す流体とのバランスを取れるのに用いられる(又は、その反対も可能である)ポンピングカセットは、所定の量の流体がバランス室に影響を及ぼす前に、この所定の量の流体を除去し、又は、バランス室に影響を及ぼす前に、この所定の量の流体を付加するための定量ポンプを提供する。
8.統合型カセットシステムの例示的な実施形態
上記のように、混合カセットは、透析液を混合し、次いで透析液を貯蔵ベッセル又は貯蔵容器に送るために用いられる。外側透析液とも称される中間カセットは、コンテナ、さらに様々な流路及びポートのためのベントを提供し、また、バランスカセットは、一方向に沿ってカセットに流入する流体の量を、他の方向に沿ってカセットに流入する量とバランスを取れるためのシステムを提供する。追加的に、バランスカセットは、定量機能を提供し、ここで、一方向からの流体の量が、バランス室を迂回するように、またバランス量に影響を及ぼさないように汲み出される。いくつかの実施形態において、この3つのカセットが、1つのシステムで組み合わせられる。統合型カセットシステムが形成されるように、流路がカセットに連結される。しかし、数個のホースは、管理し難く、また絡み合うことがあり、ポートへの連結及び分離が様々な方式で妨害され得る。
付記1. ポンピングカセットであって、
少なくとも2つの流入口流路及び少なくとも2つの排出口流路を含むハウジングと、
前記ハウジング内に位置され、前記流体ラインと流体連通されることにより、第1流体の量と第2流体の量が同一になるように、第1流体の流動と第2流体の流動のバランスを取る少なくとも1つのバランスポッドであって、二つのバランス室を形成する膜を含む、前記バランスポッドと、
前記ハウジング内で、少なくとも1つの往復運動型圧力変位膜ポンプであって、前記圧力ポンプが流入口流体ラインから排出口流体ラインへと第1流体を汲み出し、且つ、流入口流体ラインから排出口流体ラインまで前記第2流体を汲み出す、前記少なくとも1つの往復運動型圧力変位膜ポンプと、
流路に流体連通される前記ハウジング内の定量ポンプとを備え、
前記定量ポンプが、
所定の量の流体を汲み出すことと、
前記圧力ポンプ及び前記定量ポンプは、空圧式で作動されるポンプであることと、
前記流体がバランス室を迂回するように、所定の量の流体を汲み出し、且つ、前記定量ポンプが膜ポンプであることと
のうち少なくとも1つを特徴とする、ポンピングカセット。
付記2. 少なくとも1つの流体弁、または少なくとも2つの流体弁を更に備え、前記少なくとも2つの流体弁が1つの空圧弁によって作動される、付記1に記載のポンピングカセット。
付記3. ポンプカセットであって、
少なくとも1つの流体流入口ライン及び少なくとも1つの流体排出口ラインを含むハウジングと、
前記ハウジング内の少なくとも1つの往復運動型圧力変位ポンプであって、前記圧力ポンプは、少なくとも1つの流体を前記流体流入口ラインから前記流体排出口ラインの少なくとも1つへと汲み出す、前記少なくとも1つの往復運動型圧力変位膜ポンプと、
前記流体排出口ラインに流体連通される前記ハウジング内の少なくとも1つの混合室とを備えるポンピングカセット。
付記4. 少なくとも1つの弁と、膜を有する弁ハウジングを含み、前記膜が前記弁ハウジングを二つの室に分割する、少なくとも1つの弁とのうちのいずれかをさらに備える、付記3に記載のポンピングカセット。
付記5. 前記混合室が、少なくとも1つの流体流入口と少なくとも1つの流体排出口とを有する曲線状の硬質な室壁を含む、付記3または4に記載のポンピングカセット。
付記6. 前記ハウジング内の少なくとも1つの定量膜ポンプをさらに備え、前記定量ポンプは、前記ハウジング上の前記混合室と定量ポンプ流路とに流体連通され、前記定量ポンプ流路は、少なくとも1つの流体流入口ラインの少なくとも1つに流体連通されるか、または第2流体流入口ラインに連結される、付記3、4、または5に記載のポンピングカセット。
付記7. ポンピングカセットであって、
少なくとも1つの流体ポートと少なくとも1つの通気口とを含むハウジングであって、前記通気口が前記ハウジングの外部に流体ソースを排出する、前記ハウジングと、
前記ハウジング内の少なくとも1つの往復運動型圧力変位膜ポンプと
を備え、前記ポンプが流体を汲み出す、ポンピングカセット。
付記8. 前記往復運動型圧力変位ポンプが、
曲線状の硬質な室壁と、
前記硬質な室壁に付着された可撓性膜と
を含み、前記可撓性膜及び硬質な室壁がポンプ室を画定することと、
前記カセットハウジングが、
天板と、
中板と、
低板と
を含むことと
のうちの少なくとも1つを特徴とする、付記1、3または7に記載のポンピングカセット。
付記9. 少なくとも1つの弁、
膜弁である少なくとも1つの弁、
膜を有する弁ハウジングを含み、前記膜が前記ハウジングを二つの室に分割する、少なくとも1つの弁、
膜を有する弁ハウジングを含み、前記膜が前記ハウジングを二つの室に分割し、前記二つの室の1つが作動室であり、前記二つの室の1つが流体ポンプ室である、少なくとも1つの弁、
膜を有する弁ハウジングを含み、前記膜が前記ハウジングを二つの室に分割し、前記二つの室の1つが作動室であり、前記作動室が少なくとも1つの開口を有し、前記流体ポンプ室が少なくとも1つの開口を有する、少なくとも1つの弁、または
膜を有する弁ハウジングを含み、前記膜が前記ハウジングを二つの室に分割し、前記二つの室の1つが作動室であり、前記作動室が、二つの開口を含む、少なくとも1つの弁をさらに備え、
前記弁が、火山形状弁であることと、前記流体ポンプ室が、実質的に滑らかな表面を含むこととのうちの少なく1つを特徴とする、付記7または8に記載のポンピングカセット。
付記10. 前記弁が、逆止め弁である、付記9に記載のポンピングカセット。
Claims (11)
- ポンピングカセットであって、
少なくとも2つの流入口流路及び少なくとも2つの排出口流路を含むハウジングと、
前記ハウジング内に位置され、前記流体ラインと流体連通されることにより、第1流体の量と第2流体の量が同一になるように、第1流体の流動と第2流体の流動のバランスを取る少なくとも1つのバランスポッドであって、二つのバランス室を形成する膜を含む、前記バランスポッドと、
前記ハウジング内で、少なくとも1つの往復運動型圧力変位膜ポンプであって、前記圧力ポンプが流入口流体ラインから排出口流体ラインへと第1流体を汲み出し、且つ、流入口流体ラインから排出口流体ラインまで前記第2流体を汲み出す、前記少なくとも1つの往復運動型圧力変位膜ポンプと
を備える、ポンピングカセット。 - 流路に流体連通される前記ハウジング内の定量ポンプをさらに備え、
前記定量ポンプが、
所定の量の流体を汲み出すことと、
前記圧力ポンプ及び前記定量ポンプは、空圧式で作動されるポンプであることと、
前記流体がバランス室を迂回するように、所定の量の流体を汲み出し、且つ、前記定量ポンプが膜ポンプであることと
のうち少なくとも1つを特徴とする、請求項1に記載のポンピングカセット。 - 少なくとも1つの流体弁、または少なくとも2つの流体弁を更に備え、前記少なくとも2つの流体弁が1つの空圧弁によって作動される、請求項1または2に記載のポンピングカセット。
- ポンプカセットであって、
少なくとも1つの流体流入口ライン及び少なくとも1つの流体排出口ラインを含むハウジングと、
前記ハウジング内の少なくとも1つの往復運動型圧力変位ポンプであって、前記圧力ポンプは、少なくとも1つの流体を前記流体流入口ラインから前記流体排出口ラインの少なくとも1つへと汲み出す、前記少なくとも1つの往復運動型圧力変位膜ポンプと、
前記流体排出口ラインに流体連通される前記ハウジング内の少なくとも1つの混合室とを備えるポンピングカセット。 - 少なくとも1つの弁と、膜を有する弁ハウジングを含み、前記膜が前記弁ハウジングを二つの室に分割する、少なくとも1つの弁とのうちのいずれかをさらに備える、請求項4に記載のポンピングカセット。
- 前記混合室が、少なくとも1つの流体流入口と少なくとも1つの流体排出口とを有する曲線状の硬質な室壁を含む、請求項4または5に記載のポンピングカセット。
- 前記ハウジング内の少なくとも1つの定量膜ポンプをさらに備え、前記定量ポンプは、前記ハウジング上の前記混合室と定量ポンプ流路とに流体連通され、前記定量ポンプ流路は、少なくとも1つの流体流入口ラインの少なくとも1つに流体連通されるか、または第2流体流入口ラインに連結される、請求項4、5または6に記載のポンピングカセット。
- ポンピングカセットであって、
少なくとも1つの流体ポートと少なくとも1つの通気口とを含むハウジングであって、前記通気口が前記ハウジングの外部に流体ソースを排出する、前記ハウジングと、
前記ハウジング内の少なくとも1つの往復運動型圧力変位膜ポンプと
を備え、前記ポンプが流体を汲み出す、ポンピングカセット。 - 前記往復運動型圧力変位ポンプが、
曲線状の硬質な室壁と、
前記硬質な室壁に付着された可撓性膜と
を含み、前記可撓性膜及び硬質な室壁がポンプ室を画定することと、
前記カセットハウジングが、
天板と、
中板と、
低板と
を含むことと
のうちの少なくとも1つを特徴とする、請求項1、4又は8に記載のポンピングカセット。 - 少なくとも1つの弁、
膜弁である少なくとも1つの弁、
膜を有する弁ハウジングを含み、前記膜が前記ハウジングを二つの室に分割する、少なくとも1つの弁、
膜を有する弁ハウジングを含み、前記膜が前記ハウジングを二つの室に分割し、前記二つの室の1つが作動室であり、前記二つの室の1つが流体ポンプ室である、少なくとも1つの弁、
膜を有する弁ハウジングを含み、前記膜が前記ハウジングを二つの室に分割し、前記二つの室の1つが作動室であり、前記作動室が少なくとも1つの開口を有し、前記流体ポンプ室が少なくとも1つの開口を有する、少なくとも1つの弁、または
膜を有する弁ハウジングを含み、前記膜が前記ハウジングを二つの室に分割し、前記二つの室の1つが作動室であり、前記作動室が、二つの開口を含む、少なくとも1つの弁をさらに備え、
前記弁が、火山形状弁であることと、前記流体ポンプ室が、実質的に滑らかな表面を含むこととのうちの少なく1つを特徴とする、請求項8または9に記載のポンピングカセット。 - 前記弁が、逆止め弁である、請求項10に記載のポンピングカセット。
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