TWI702062B - Systems and methods for quantifying conductance in the vasculature - Google Patents
Systems and methods for quantifying conductance in the vasculature Download PDFInfo
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- TWI702062B TWI702062B TW104136376A TW104136376A TWI702062B TW I702062 B TWI702062 B TW I702062B TW 104136376 A TW104136376 A TW 104136376A TW 104136376 A TW104136376 A TW 104136376A TW I702062 B TWI702062 B TW I702062B
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特徵化脈管中之血流之能力可在手術或其他醫療程序之前提供有用洞察,或用於一般患者監控。例如,感興趣之區可為在心臟之近端之脈管。作為一非限制性實例,此資料可用來在判定用於一操作程序之方法之前提供對主動脈縮窄或其他狀況之嚴重性之洞察。可用來在脈管中建立流模式或流容積之資料可用於定量一狀況(諸如但不限於主動脈縮窄)之嚴重性。 The ability to characterize blood flow in a vessel can provide useful insights before surgery or other medical procedures, or for general patient monitoring. For example, the region of interest can be a vessel at the proximal end of the heart. As a non-limiting example, this data can be used to provide insight into the severity of aortic coarctation or other conditions before determining the method used in an operating procedure. Data that can be used to establish flow patterns or flow volumes in a vessel can be used to quantify the severity of a condition such as, but not limited to, aortic coarctation.
本發明提供允許在脈管之一區中使用耦合至至少兩個壓力感測器之一導管構件定量流傳導之例示性系統、器件、裝置及方法。在該導管構件處依已知的流率控制模式量測壓力所得之資料可用來計算流傳導之值。作為非限制性實例,該等系統、器件、裝置及方法可用來定量在該導管構件之近端之近端外部傳導或遠端外部傳導。在該導管構件之近端之近端外部傳導或遠端外部傳導之值可在手術或其他醫療程序之前提供對脈管狀況之有用洞察,或用於一般患者監控。 The present invention provides exemplary systems, devices, devices and methods that allow quantitative flow conduction in a region of a vessel using a catheter member coupled to at least two pressure sensors. The data obtained by measuring the pressure at the duct member according to the known flow rate control mode can be used to calculate the value of flow conduction. As non-limiting examples, the systems, devices, devices, and methods can be used to quantify the proximal external conduction or the distal external conduction at the proximal end of the catheter member. The value of the proximal external conduction or the distal external conduction at the proximal end of the catheter member can provide useful insights into vascular conditions before surgery or other medical procedures, or for general patient monitoring.
在一實例中,該壓力感測器之至少一者耦合至該導管構件之一遠端尖端,且至少一個其他壓力感測器定位於該遠端尖端之近端,且定位於該導管構件軸件之近端。從該導管構件依已知的流率控制模式量測壓力所得之資料可用來計算在該導管構件之近端之近端外部傳導 或遠端外部傳導之值。 In an example, at least one of the pressure sensors is coupled to a distal tip of the catheter member, and at least one other pressure sensor is positioned at the proximal end of the distal tip and positioned on the catheter member shaft The near end of the piece. The data obtained from the pressure measurement of the catheter member according to the known flow rate control mode can be used to calculate the proximal external conduction at the proximal end of the catheter member Or the value of remote external conduction.
在一實例中,該脈管之區可在心臟之近端。 In one example, the region of the vessel may be at the proximal end of the heart.
例示性系統、器件及裝置可包含一導管構件及一控制分流系統。該導管構件包含一遠端尖端及具有一管腔之一軸件。該控制分流系統包含:至少一第一壓力感測器,其安置於該導管構件之遠端尖端之近端;至少一第二壓力感測器,其安置於該導管構件之軸件之一外表面上,安置於該遠端尖端之近端;及一注入流率源,其耦合至該導管構件,以在該管腔中導致依一預定流率模式之注入流。 Exemplary systems, devices, and devices may include a conduit member and a control shunt system. The catheter component includes a distal tip and a shaft with a lumen. The control shunt system includes: at least one first pressure sensor arranged at the proximal end of the distal tip of the catheter member; at least one second pressure sensor arranged outside one of the shafts of the catheter member On the surface, arranged at the proximal end of the distal tip; and an injection flow rate source coupled to the catheter member to cause an injection flow in the lumen according to a predetermined flow rate pattern.
例示性系統、器件及裝置可經結構設計以使用一導管及至少兩個壓力感測器實施一方法。該例示性方法包含將該導管構件耦合至一身體之一部分。該導管構件包含一遠端尖端及具有一管腔之一軸件。至少一第一壓力感測器安置於該導管構件之遠端尖端之近端。至少一第二壓力感測器安置於該導管構件之軸件之一外表面上,安置於於該遠端尖端之近端。該方法進一步包含:在一時間間隔T內,將於該遠端尖端處注入之流體之流控制至一預定流率模式;在該時間間隔T內,記錄使用至少該第一壓力感測器及該第二壓力感測器之壓力量測;及使用指示該等壓力量測及該預定流率模式之資料計算該遠端尖端處之一近端外部傳導或一遠端外部傳導之至少一者。 Exemplary systems, devices, and devices can be structurally designed to implement a method using a catheter and at least two pressure sensors. The exemplary method includes coupling the catheter member to a part of a body. The catheter component includes a distal tip and a shaft with a lumen. At least one first pressure sensor is arranged at the proximal end of the distal tip of the catheter member. At least one second pressure sensor is arranged on an outer surface of the shaft of the catheter member, and is arranged at the proximal end of the distal tip. The method further comprising: during a time interval T, will be injected into the fluid at the distal tip ilk to a predetermined flow rate control mode; within the time interval T is recorded using at least the first pressure sensor and Pressure measurement of the second pressure sensor; and calculating at least one of a proximal external conduction or a distal external conduction at the distal tip using data indicating the pressure measurements and the predetermined flow rate mode .
例示性系統、器件及裝置可包含一導管構件、一控制分流系統及一控制台。該導管構件包含一遠端尖端及具有一管腔之一軸件。該控制分流系統包含:至少一第一壓力感測器,其安置於該導管構件之遠端尖端之近端;至少一第二壓力感測器,其安置於該導管構件之軸件之一外表面上,安置於該遠端尖端之近端;及一注入流率源,其耦合至該導管構件,以在該管腔中導致依一預定流率模式之注入流。該控制台包含一顯示單元;及至少一個處理單元,其經程式化以:基於使用至少該第一壓力感測器及至少該第二壓力感測器進行之壓力量 測,計算一傳導之一值;及產生一信號以導致該顯示單元顯示該傳導值之一指示。 Exemplary systems, devices, and devices may include a conduit member, a control shunt system, and a console. The catheter component includes a distal tip and a shaft with a lumen. The control shunt system includes: at least one first pressure sensor arranged at the proximal end of the distal tip of the catheter member; at least one second pressure sensor arranged outside one of the shafts of the catheter member On the surface, arranged at the proximal end of the distal tip; and an injection flow rate source coupled to the catheter member to cause an injection flow in the lumen according to a predetermined flow rate pattern. The control panel includes a display unit; and at least one processing unit, which is programmed to: based on the amount of pressure performed using at least the first pressure sensor and at least the second pressure sensor Measuring, calculating a value of a conduction; and generating a signal to cause the display unit to display an indication of the conduction value.
例示性系統、器件及裝置可經結構設計以使用一導管及一控制分流系統實施一方法。該方法包含將該導管構件耦合至一身體之一部分。該導管構件包含一遠端尖端及具有一管腔之一軸件。該控制分流系統包含:至少一第一壓力感測器,其安置於該導管構件之遠端尖端之近端;至少一第二壓力感測器,其安置於該導管構件軸件之一外表面上,安置於該遠端尖端之近端;及一注入流率源,其耦合至該導管構件,以在該管腔中導致依一預定流率模式之注入流。該例示性方法包含:在一第一時間間隔T 1 內,使用該注入流率源將於該遠端尖端處注入之流體流控制至一預定流率模式;在該第一時間間隔T 1 內,記錄使用該第一壓力感測器及該第二壓力感測器之壓力量測;使用指示該等壓力量測及該預定流率模式之資料計算該遠端尖端處之一近端外部傳導之一值;使用該等第一及第二壓力量測以及該經計算之近端外部傳導計算外部流率,且使用該外部流率來計算在該遠端混合流體中經注入流率對外部流率之比率;及控制添加至該經注入流體之藥物或藥劑之該量,且使用經注入流率對外部流率之該經計算比率調整該量以便導出在該混合遠端流體中藥物或藥劑之一指定濃度。 Exemplary systems, devices, and devices can be structurally designed to implement a method using a catheter and a control shunt system. The method includes coupling the catheter member to a part of a body. The catheter component includes a distal tip and a shaft with a lumen. The control shunt system includes: at least one first pressure sensor arranged on the proximal end of the distal tip of the catheter member; at least one second pressure sensor arranged on an outer surface of the catheter member shaft The upper part is disposed at the proximal end of the distal tip; and an injection flow rate source coupled to the catheter member to cause an injection flow in the lumen according to a predetermined flow rate pattern. The exemplary method includes: in a first time interval T 1 , using the injection flow rate source to control the flow of fluid injected at the distal tip to a predetermined flow rate mode; in the first time interval T 1 , Record the pressure measurement using the first pressure sensor and the second pressure sensor; use the data indicating the pressure measurements and the predetermined flow rate mode to calculate a proximal external conduction at the distal tip A value; the first and second pressure measurements and the calculated proximal external conduction are used to calculate the external flow rate, and the external flow rate is used to calculate the injection flow rate in the distal mixed fluid to the external And control the amount of drug or medicament added to the injected fluid, and use the calculated ratio of injected flow rate to external flow rate to adjust the amount so as to derive the drug or medicament in the mixed distal fluid One of the agents specifies the concentration.
應明白,前述概念及下文更詳細論述之額外概念之所有組合(前提係此等概念不相互抵觸)被視為本文中所揭示之本發明標的物之部分。特定言之,出現於本發明結尾處之所主張標的之所有組合被視為本文中所揭示之本發明標的之部分。亦應明白,亦可出現於以引用方式併入任何揭示內容中之本文中明確採用之術語應被賦予最符合本文中所揭示之特定概念之一意義。 It should be understood that all combinations of the aforementioned concepts and the additional concepts discussed in more detail below (provided that these concepts are not conflicting) are regarded as part of the subject matter of the present invention disclosed herein. In particular, all combinations of the claimed subject matter appearing at the end of the present invention are regarded as part of the subject matter of the present invention disclosed herein. It should also be understood that the terms explicitly used in this article that can also appear in any disclosure incorporated by reference should be given a meaning that best fits the specific concepts disclosed in this article.
100:導管系統 100: Catheter system
101:軸件 101: Shaft
102:平面 102: plane
103:閉塞組件 103: occlusion component
200:體外環路 200: extracorporeal loop
203:閉塞組件 203: Occlusion component
205:死區域 205: Dead Zone
206:泵系統 206: Pump System
208:熱交換器 208: Heat Exchanger
210:注入器構件 210: Injector component
212:脈管注入點 212: Vessel Injection Point
214:血液 214: Blood
216:注入流體 216: Inject fluid
320:管腔 320: Lumen
321:組件/軟氣囊 321: Module/Soft Airbag
324:正向新沖洗流 324: Positive new flush flow
326:反向沖洗流 326: Backflush flow
328:血流 328: Blood Flow
421:組件 421: Components
424:反向沖洗流 424: Backflush flow
426:正向沖洗流 426: Forward flushing flow
428:血流 428: Blood Flow
430:孔/孔口 430: Hole/Orifice
431:孔/孔徑 431: Hole/Aperture
440:彈簧驅動膜 440: Spring Driven Film
442:流體流 442: Fluid Flow
450:多葉軟氣囊 450: Multi-leaf soft airbag
455:雙葉軟氣囊 455: Futaba Soft Airbag
460:間隙 460: gap
465:三葉軟氣囊 465: Clover soft airbag
470:間隙 470: gap
510:偏置閥 510: Bias valve
521:組件/軟氣囊 521: Module/Soft Airbag
532:偏置閥 532: offset valve
534:流 534: flow
538:血流 538: Blood Flow
540:偏置閥 540: offset valve
542:旁通管腔 542: Bypass Lumen
548:血流 548: Blood Flow
610:第一壓力感測器 610: The first pressure sensor
612:第二壓力感測器 612: second pressure sensor
614:注入器構件/***構件/內軸件 614: injector component/insertion component/inner shaft
615:血流 615: Blood Flow
616:流率源 616: Flow Rate Source
617:血流 617: Blood Flow
618:外軸件 618: Outer shaft
620:導管構件/導管 620: Conduit member/duct
622:近端埠 622: Near End Port
700:體外系統 700: Extracorporeal System
700':體外系統 700': Extracorporeal system
700"‧‧‧體外系統 700"‧‧‧Extracorporeal System
710‧‧‧主靜脈-動脈(VA)體外迴路 710‧‧‧Aorta-arterial (VA) extracorporeal circuit
711‧‧‧第一埠 711‧‧‧First port
712‧‧‧泵 712‧‧‧Pump
713‧‧‧氧合器 713‧‧‧ Oxygenator
714‧‧‧主迴路氧合器/熱交換器 714‧‧‧Main circuit oxygenator/heat exchanger
715‧‧‧第二埠 715‧‧‧Second Port
716‧‧‧排量或容積驅動泵 716‧‧‧Displacement or volume drive pump
718‧‧‧區域注入器分支 718‧‧‧Regional injector branch
720‧‧‧熱交換器 720‧‧‧Heat exchanger
721‧‧‧第三埠 721‧‧‧The third port
722‧‧‧遠端注入器構件 722‧‧‧Remote injector component
724‧‧‧區域 724‧‧‧area
726‧‧‧外加最小傳導組件 726‧‧‧plus the smallest conductive component
728‧‧‧耦合壓力感測器對 728‧‧‧Coupling pressure sensor pair
800‧‧‧體外環路系統 800‧‧‧Extracorporeal Loop System
802‧‧‧控制台 802‧‧‧Console
810‧‧‧主靜脈-動脈(VA)體外迴路 810‧‧‧Aorta-arterial (VA) extracorporeal circuit
811‧‧‧第一埠 811‧‧‧First port
812‧‧‧泵 812‧‧‧Pump
813‧‧‧氧合器 813‧‧‧Oxygenator
814‧‧‧熱交換器 814‧‧‧Heat exchanger
815‧‧‧第二埠 815‧‧‧Second Port
816‧‧‧排量或容積驅動泵 816‧‧‧Displacement or volume drive pump
818‧‧‧分支 818‧‧‧ branch
820‧‧‧熱交換器 820‧‧‧Heat exchanger
821‧‧‧第三埠 821‧‧‧The third port
822‧‧‧遠端注入器構件 822‧‧‧Remote injector component
826‧‧‧外加最小傳導組件 826‧‧‧plus the smallest conductive components
828‧‧‧壓力感測器對 828‧‧‧Pressure sensor pair
850‧‧‧系統 850‧‧‧System
852‧‧‧控制台 852‧‧‧Control Panel
860‧‧‧流率控制源 860‧‧‧Flow rate control source
862‧‧‧儲液器 862‧‧‧Liquid reservoir
872‧‧‧遠端注入器構件 872‧‧‧Remote injector component
876‧‧‧外加最小傳導組件 876‧‧‧plus the smallest conductive components
878‧‧‧壓力感測器對 878‧‧‧Pressure sensor pair
905‧‧‧控制台 905‧‧‧Console
907‧‧‧處理單元 907‧‧‧Processing unit
909‧‧‧記憶體 909‧‧‧Memory
911‧‧‧顯示單元 911‧‧‧Display unit
1002‧‧‧步驟 1002‧‧‧step
1004‧‧‧步驟 1004‧‧‧Step
1006‧‧‧步驟 1006‧‧‧Step
1052‧‧‧步驟 1052‧‧‧Step
1054‧‧‧步驟 1054‧‧‧Step
1056‧‧‧步驟 1056‧‧‧Step
1058‧‧‧步驟 1058‧‧‧Step
1060‧‧‧步驟 1060‧‧‧step
1110‧‧‧計算器件 1110‧‧‧Computer device
1112'‧‧‧處理器 1112'‧‧‧Processor
1114‧‧‧核心 1114‧‧‧Core
1114'‧‧‧核心 1114'‧‧‧Core
1118‧‧‧多點觸控介面 1118‧‧‧Multi-touch interface
1120‧‧‧指向器件 1120‧‧‧Pointing device
1124‧‧‧虛擬機 1124‧‧‧Virtual Machine
1126‧‧‧作業系統 1126‧‧‧Operating System
1132‧‧‧網路器件 1132‧‧‧Network Device
1134‧‧‧儲存器件 1134‧‧‧Storage device
1140‧‧‧軟體應用程式 1140‧‧‧Software applications
Fb‧‧‧流率/流體/流/血流 F b ‧‧‧Flow rate/fluid/flow/blood flow
Ftip‧‧‧流率/流體/流/血流 F tip ‧‧‧Flow rate/fluid/flow/blood flow
G0‧‧‧流體傳導 G 0 ‧‧‧ Fluid conduction
Gb‧‧‧近端傳導 G b ‧‧‧ proximal conduction
Gtip‧‧‧遠端傳導 G tip ‧‧‧Remote conduction
l‧‧‧離散長度 l ‧‧‧Discrete length
Pa‧‧‧壓力 Pa‧‧‧Pressure
Pb‧‧‧壓力 Pb‧‧‧Pressure
Pin‧‧‧壓力 P in ‧‧‧Pressure
Pout‧‧‧壓力 P out ‧‧‧Pressure
Ptip‧‧‧壓力 P tip ‧‧‧Pressure
△‧‧‧預界定間距 △‧‧‧Predefined spacing
△t‧‧‧時間週期 △t‧‧‧Time period
一般技術者將瞭解,圖式主要用於繪示目的且並非意欲於限制 本文中所述之本發明標的之範疇。圖式不一定按比例繪製;在一些例項中,本文中所揭示之本發明標的之各個態樣可在圖式中被展示為擴大或放大以促進對不同特徵之一理解。在圖式中,類似參考字元通常指代類似特徵(例如,功能類似及/或結構類似的元件)。 The skilled person will understand that the schema is mainly used for illustration purposes and is not intended to be limiting The scope of the subject matter of the present invention described herein. The drawings are not necessarily drawn to scale; in some examples, various aspects of the subject matter of the invention disclosed herein may be shown as enlarged or enlarged in the drawings to facilitate understanding of one of the different features. In the drawings, similar reference characters generally refer to similar features (for example, elements with similar functions and/or similar structures).
圖1A展示根據本發明之原理之一例示性導管系統之一示意圖。 Figure 1A shows a schematic diagram of an exemplary catheter system according to one of the principles of the present invention.
圖1B至圖1C展示跨邊界之脈管空間中之流體傳導之例示性圖表。 Figures 1B to 1C show exemplary diagrams of fluid conduction in the vascular space across the boundary.
圖2A展示根據本發明之原理之一例示性體外環路。 Figure 2A shows an exemplary extracorporeal loop according to one of the principles of the present invention.
圖2B至圖2C展示根據本發明之原理之另一導管系統之示意圖。 2B to 2C show schematic diagrams of another catheter system according to the principles of the present invention.
圖3A至圖3B展示根據本發明之原理之另一導管系統之實例。 3A to 3B show an example of another catheter system according to the principles of the present invention.
圖4A至圖4B展示根據本發明之原理之另一導管系統之實例。 4A to 4B show an example of another catheter system according to the principles of the present invention.
圖4C展示根據本發明之原理之另一導管系統之一實例。 Figure 4C shows an example of another catheter system according to the principles of the present invention.
圖4D(i)及圖4D(ii)展示根據本發明之原理之另一導管系統之一實例。 4D(i) and 4D(ii) show an example of another catheter system according to the principles of the present invention.
圖5A(i)及圖5A(ii)展示根據本發明之原理之一例示性導管系統中之一孔徑上之一偏置閥之一實例。 Figures 5A(i) and 5A(ii) show an example of an offset valve on an aperture in an exemplary catheter system according to the principles of the present invention.
圖5B展示根據本發明之原理之一例示性導管系統中之一孔徑上之一偏置閥之一實例。 Figure 5B shows an example of an offset valve on an aperture in an exemplary catheter system according to the principles of the present invention.
圖5C展示根據本發明之原理之一例示性導管系統中之一孔徑上之一偏置閥之一實例。 Figure 5C shows an example of a bias valve on an aperture in an exemplary catheter system according to the principles of the present invention.
圖6A展示根據本發明之原理之耦合至一例示性導管系統中之壓力感測器之一例示性注入器構件。 Figure 6A shows an exemplary injector component coupled to a pressure sensor in an exemplary catheter system in accordance with the principles of the present invention.
圖6B展示根據本發明之原理之耦合至一例示性導管系統中之壓力感測器之另一例示性注入器構件。 Figure 6B shows another exemplary injector component coupled to a pressure sensor in an exemplary catheter system in accordance with the principles of the present invention.
圖6C展示根據本發明之原理之耦合至壓力感測器之一例示性導管。 Figure 6C shows an exemplary catheter coupled to a pressure sensor in accordance with the principles of the present invention.
圖6D展示根據本發明之原理之耦合至壓力感測器之另一例示性導管。 Figure 6D shows another exemplary catheter coupled to a pressure sensor in accordance with the principles of the present invention.
圖7A展示根據本發明之原理之一例示性體外環路系統。 Figure 7A shows an exemplary extracorporeal loop system according to one of the principles of the present invention.
圖7B展示根據本發明之原理之另一例示性體外環路系統。 Figure 7B shows another exemplary extracorporeal loop system in accordance with the principles of the present invention.
圖7C展示根據本發明之原理之另一例示性體外環路系統。 Figure 7C shows another exemplary extracorporeal loop system in accordance with the principles of the present invention.
圖8A展示根據本發明之原理之耦合至一控制台之一例示性體外環路系統。 Figure 8A shows an exemplary extracorporeal loop system coupled to a console in accordance with the principles of the present invention.
圖8B展示根據本發明之原理之耦合至一控制台之另一例示性體外環路系統。 Figure 8B shows another exemplary extracorporeal loop system coupled to a console in accordance with the principles of the present invention.
圖9為展示根據本發明之原理之一例示性計算器件之一方塊圖。 FIG. 9 is a block diagram showing an exemplary computing device according to the principles of the present invention.
圖10A至圖10B展示繪示根據本發明之原理之例示性方法之流程圖。 10A to 10B show a flowchart illustrating an exemplary method according to the principles of the present invention.
圖11為根據本發明之原理之一例示性計算器件方塊圖。 FIG. 11 is a block diagram of an exemplary computing device according to one of the principles of the present invention.
下文為關於允許在脈管之一區中使用耦合至至少兩個壓力感測器之一導管構件定量流傳導之系統、器件、裝置及方法之各種概念及其實施例之更詳細描述。應明白,可依眾多方式之任何一種實施上文介紹且下文更詳細論述之各種概念,此係因為所揭示概念不限於任何特定實施方式。特定實施方案及應用之實例主要出於闡釋目的而提供。 The following is a more detailed description of various concepts and embodiments of systems, devices, devices, and methods that allow quantitative flow conduction using a catheter member coupled to at least two pressure sensors in a region of a vessel. It should be understood that the various concepts introduced above and discussed in more detail below can be implemented in any of numerous ways, because the disclosed concepts are not limited to any particular implementation. Examples of specific implementations and applications are provided primarily for illustrative purposes.
如本文中所使用,術語「包含(include)」意謂著包含但不限於,術語「包含(including)」意謂著包含但不限於。術語「基於」意謂著至少部分基於。 As used herein, the term "include" means including but not limited to, and the term "including" means including but not limited to. The term "based on" means based at least in part on.
關於本文中結合本文原理之各項實例所述之表面,對「頂部」表面及「底部」表面之任何參考主要用來指示各種元件/組件關於基板及彼此之相對位置、對準及/或定向,且此等術語不一定指示任何 特定參考系(例如,一重力參考系)。因此,對一表面或層之一「底部」之參考不一定要求所指示表面或層面向地面。類似地,諸如「上方」、「下方」、「上面」、「下面」等之術語不一定指示任何特定參考系(諸如一重力參考系),而是主要用來指示各種元件/組件關於表面及彼此之相對位置、對準及/或定向。 Regarding the surfaces described in the various examples of the principles herein, any reference to the "top" surface and the "bottom" surface is mainly used to indicate the relative position, alignment and/or orientation of various components/components with respect to the substrate and each other , And these terms do not necessarily indicate any A specific frame of reference (for example, a gravitational frame of reference). Therefore, a reference to a "bottom" of a surface or layer does not necessarily require that the indicated surface or layer face the ground. Similarly, terms such as "above", "below", "above", "below", etc. do not necessarily indicate any specific reference system (such as a gravitational reference system), but are mainly used to indicate various elements/components with respect to the surface and The relative position, alignment and/or orientation of each other.
術語「安置於...上」及「安置於...上方」涵蓋「嵌入於...中」(包含「部分嵌入於...中」)之意義。此外,對特徵A「安置於特徵B上」、「安置於特徵B之間」或「安置於特徵B上方」之參考涵蓋其中特徵A與特徵B接觸之實例以及其中其他層及/或其他組件定位於特徵A與特徵B之間的實例。 The terms "placed on" and "placed on" cover the meaning of "embedded in" (including "partially embedded in"). In addition, the reference to feature A "placed on feature B", "placed between feature B", or "placed above feature B" covers the instance where feature A is in contact with feature B and other layers and/or other components therein An instance located between feature A and feature B.
如本文中所使用,術語「近端」指代朝向一使用者將操作之一導管、一注入器構件或其他儀器之一部分(諸如但不限於一握把或其他手柄)之一方向。如本文中所使用,術語「遠端」指代遠離該導管、注入器構件或其他儀器之握把或其他手柄之一方向。例如,該注入器構件之尖端安置於該注入器構件之一遠端部分處。 As used herein, the term "proximal end" refers to a direction toward a part of a catheter, an injector member, or other instrument that a user will operate, such as but not limited to a grip or other handle. As used herein, the term "distal" refers to a direction away from the handle or other handle of the catheter, injector member, or other instrument. For example, the tip of the injector member is disposed at a distal end portion of the injector member.
本發明描述允許在脈管之一區中使用耦合至至少兩個壓力感測器之一導管構件定量流傳導之各種例示性系統、器件、裝置及方法。在該導管構件處依已知的流率控制模式量測壓力所得之資料可用來計算該脈管之區之流傳導之值。 The present invention describes various exemplary systems, devices, devices, and methods that allow the use of a catheter member coupled to at least two pressure sensors to conduct quantitative flow in a region of a vessel. The data obtained by measuring the pressure at the catheter member according to the known flow rate control mode can be used to calculate the value of the flow conduction in the region of the vessel.
流傳導之值可用來特徵化脈管中之血流,其可在一操作程序或其他醫療程序之前提供有用洞察,或用於一般患者監控。流傳導之值可用來在脈管中建立流模式或流容積,且可用來定量一狀況之嚴重性。 The value of flow conduction can be used to characterize blood flow in a vessel, which can provide useful insights before an operating procedure or other medical procedures, or for general patient monitoring. The value of flow conduction can be used to establish a flow pattern or flow volume in a vessel, and can be used to quantify the severity of a condition.
作為非限制性實例,系統、器件、裝置及方法可用來定量在該導管構件之近端之近端外部傳導或遠端外部傳導。在該導管構件之近端之近端外部傳導或遠端外部傳導之值可在手術或其他醫療程序之前 提供對脈管狀況之有用洞察,或用於一般患者監控。 As non-limiting examples, systems, devices, devices, and methods can be used to quantify proximal external conduction or distal external conduction at the proximal end of the catheter member. The value of the proximal external conduction or the distal external conduction at the proximal end of the catheter member can be before surgery or other medical procedures Provide useful insights into vascular conditions or for general patient monitoring.
在一實例中,壓力感測器之至少一者耦合至該導管構件之一遠端尖端,且至少一個其他壓力感測器定位於該遠端尖端之近端,且定位於該導管構件之軸件之近端。從該導管構件依已知的流率控制模式量測壓力所得之資料可用來計算在該導管構件之近端之近端外部傳導或遠端外部傳導之值。 In an example, at least one of the pressure sensors is coupled to a distal tip of the catheter member, and at least one other pressure sensor is positioned at the proximal end of the distal tip and on the axis of the catheter member The near end of the piece. The data obtained from the pressure measurement of the catheter member according to the known flow rate control mode can be used to calculate the value of the proximal external conduction or the distal external conduction at the proximal end of the catheter member.
此外,在使用一導管之某些程序期間,一靜脈或一動脈之血流可被閉塞。每當血流至少部分被阻擋時,無流或低流區(包含死區域)可出現於脈管之部分中。例如,脈管內導管或其他類似器件可包含用於控制或阻擋一動脈或靜脈中之流之閉塞器件。在某些情況下,使一動脈或靜脈中之血流閉塞可產生血流明顯減少之區域或無流區,其中血液實質上係停滯的。此等區域在本文中稱為「死區域」或「無流區域」。若無流或低流區(包含死區域)持續達冗長時間週期,則組織可能缺乏血流且可能受損。在一些情況下,血流中之一死區域之長期產生可增大產生一血栓或血塊之風險,其與一患者中之一栓塞風險增大相關聯。產生關於如何最小化此等由阻擋引起的風險之問題。 In addition, during certain procedures using a catheter, blood flow in a vein or artery may be blocked. Whenever blood flow is at least partially blocked, no-flow or low-flow areas (including dead areas) may appear in the part of the vessel. For example, an intravascular catheter or other similar device may include an occlusion device for controlling or blocking the flow in an artery or vein. In some cases, occlusion of blood flow in an artery or vein can produce areas of markedly reduced blood flow or no-flow areas in which blood is substantially stagnant. These areas are referred to herein as "dead areas" or "no-flow areas". If no flow or low flow areas (including dead areas) continue for a long period of time, the tissue may lack blood flow and may be damaged. In some cases, the long-term development of a dead zone in the blood stream can increase the risk of a thrombus or blood clot, which is associated with an increased risk of embolism in a patient. Questions arise about how to minimize these risks caused by blocking.
在一些系統中,截斷至由一動脈饋送至組織之血流之風險藉由添加諸如在美國專利第5,046,503號及第5,176,638號中所述之旁通或灌注管腔而予以解決。 In some systems, the risk of interruption to the blood flow fed to the tissue by an artery is addressed by adding bypass or perfusion lumens such as those described in US Patent Nos. 5,046,503 and 5,176,638.
本發明亦描述用於控制一動脈或靜脈之一部分中之血流以控制脈管之一部分中之低流或無流區之出現及持續時間之各種例示性系統、方法及裝置。作為一非限制性實例,該等系統、器件、裝置及方法可用來控制脈管之一部分中之死區域區之出現及持續時間。 The present invention also describes various exemplary systems, methods and devices for controlling blood flow in a part of an artery or vein to control the appearance and duration of low-flow or no-flow areas in a part of a vessel. As a non-limiting example, these systems, devices, devices, and methods can be used to control the appearance and duration of a dead zone in a part of a vessel.
在一些實例中,描述用於在使用脈管內導管或其他類似器件期間控制(包含減少)流動淤塞之系統、方法及裝置。描述用於基於指示脈管區之傳導之資料控制或減少脈管中之無流或低流區域之出現之例 示性系統、裝置及方法。流動淤塞之控制可使用至少一個外加最小傳導組件或使用一控制分流系統予以實現。一例示性外加最小傳導組件可用來在脈管區中外加一所要的已知傳導值。若注入器構件外之傳導係已知的,則該注入構件處之流體注入位準可經控制使得在通常將形成一無流或低流區域(包含一死區域)之一區中存在一定量之流體流用來沖洗。一例示性控制分流系統可使用感測器量測來計算一脈管區中之傳導,藉此提供一已知傳導值。即,此等方法系統之任一者可用來提供在導管構件之外部之傳導之一已知值。運用此等已知傳導值,流體流可經控制以確保在脈管中不出現無流或低流區域,或無流或低流區域之出現之持續時間不導致組織損害或其他損害。 In some examples, systems, methods, and devices are described for controlling (including reducing) flow blockage during use of intravascular catheters or other similar devices. Describe an example used to control or reduce the occurrence of no-flow or low-flow areas in the vessel based on the data indicating the conduction of the vessel area Indicative system, device and method. The control of flow blockage can be achieved by using at least one additional minimum conduction component or by using a control shunt system. An exemplary additional minimum conduction component can be used to apply a desired known conduction value to the vascular area. If the conduction system outside the injector member is known, the fluid injection level at the injection member can be controlled so that there is a certain amount of fluid in a region that would normally form a no-flow or low-flow region (including a dead zone) The fluid stream is used for flushing. An exemplary control shunt system can use sensor measurements to calculate conduction in a vascular area, thereby providing a known conduction value. That is, any of these method systems can be used to provide a known value of conduction outside the catheter member. Using these known conductance values, fluid flow can be controlled to ensure that no flow or low flow areas appear in the vessel, or that the duration of the occurrence of no flow or low flow areas does not cause tissue damage or other damage.
減少流動淤塞之出現減小或消除在脈管部分中形成死區域或無流區域之可能性。 Reducing the occurrence of flow blockage reduces or eliminates the possibility of forming dead or no-flow areas in the vessel portion.
根據一些例示性實施方案,流動淤塞控制可透過使用一控制分流系統予以實現。該控制分流系統包含用於量測近端外部傳導及遠端外部傳導兩者之組件。該等量測藉由修改於一注入構件處注入之流來防止在該注入器構件之近端之區中之死流區域。例示性器件、系統及方法可經被動操作以量測流體流,或可主動用來透過引入或抽取一定量之流體來量測流體流。 According to some exemplary embodiments, flow fouling control can be achieved by using a control shunt system. The control shunt system includes components for measuring both the proximal external conduction and the distal external conduction. The measurements prevent dead-flow regions in the proximal region of the injector member by modifying the flow injected at an injection member. Exemplary devices, systems, and methods can be passively operated to measure fluid flow, or can be actively used to measure fluid flow by introducing or extracting a certain amount of fluid.
本發明亦描述可經主動操作以防止或減少可在操作期間形成於導管之近端之脈管之一部分中之一死區域之出現(包含沖洗)之器件、系統及方法。 The present invention also describes devices, systems and methods that can be actively operated to prevent or reduce the appearance (including flushing) of a dead area in a portion of the vessel that can be formed at the proximal end of the catheter during operation.
術語「外加最小傳導組件」在本文中用來指代控制一脈管段中之流率之減小同時基於一外加最小傳導位準確保流率不低於某個最小值之一組件。在本文中,傳導為電阻之倒數。在各項實例中,最小傳導位準可用來在小於一程序之時間長度T之一時間循環t內(即,其中t<<T)將流控制至一固定流率值(本文中稱為「固定常數」)或一平均流 率值(本文中稱為「固定平均值」)。例如,該時間循環t可為一心跳或分鐘之級別,而時間週期T可為持續一或多個小時之一操作或其他程序之時間。 The term "additional minimum conduction component" is used herein to refer to a component that controls the flow rate reduction in a vessel segment while ensuring that the flow rate is not lower than a certain minimum based on an additional minimum conduction level. In this article, conduction is the reciprocal of resistance. In various examples, the minimum conduction level can be used to control the flow to a fixed flow rate value within a time cycle t less than the time length T of a program (ie, where t << T ) (referred to herein as " Fixed constant") or an average flow rate value (referred to herein as "fixed average"). For example, the time cycle t may be of the level of a heartbeat or minute, and the time period T may be the time of an operation or other program lasting one or more hours.
根據一些例示性實施例,流動淤塞控制可透過使用經結構設計以允許在體外血液返回中改良流動控制之外加最小傳導組件及系統予以實現。本發明亦提供各種例示性外加最小傳導組件(其等限制或防止在該等外加最小傳導組件之近端之動脈或靜脈之一區中形成死區域),且亦提供特定死區域沖洗器件或子系統。 According to some exemplary embodiments, flow congestion control can be achieved through the use of structures designed to allow for improved flow control in extracorporeal blood return plus minimal conductive components and systems. The present invention also provides various exemplary additional minimal conduction components (which restrict or prevent the formation of dead areas in a region of the artery or vein at the proximal end of these additional minimal conduction components), and also provide specific dead area flushing devices or sub system.
如本文中所使用,一「注入器構件」為包含一管腔之一器件或組件。在一實例中,該管腔可用於將流體注入至脈管中,作為一獨立導管系統之部件或作為用來在一特定身體位置處將血液注入至脈管中之一例示性體外環路系統之一組件。 As used herein, an "injector member" is a device or component that includes a lumen. In one example, the lumen can be used to inject fluid into a vessel, as a component of an independent catheter system or as an exemplary extracorporeal loop system for injecting blood into a vessel at a specific body location One component.
如本文中所使用,術語「脈管注入點」指代在脈管中遠離一導管入口或脈管穿刺位置(血液在該位置處注入至身體中)之最遠端位置。 As used herein, the term "vascular injection point" refers to the most distal location in the vessel away from a catheter entrance or vascular puncture site where blood is injected into the body.
如本文中所使用,術語「周邊放置迴路」指代具有可放置成與身體脈管之一部分接觸而無需通常用來引導器件經過動脈或靜脈分支之螢光透視或任何其他等效系統之詳細導引之血液輸出(從身體至環路)及血液輸入(從環路至身體)導管(或其他輸入流埠及/或輸出流埠構件)之一例示性體外環路。此為所有可能放置之一子集,一些放置透過周邊循環進行且一些放置透過中央循環進行。 As used herein, the term "peripheral placement circuit" refers to a detailed guide that can be placed in contact with a part of a body vessel without the need for fluoroscopy or any other equivalent system that is normally used to guide devices through arterial or venous branches. The blood output (from the body to the loop) and blood input (from the loop to the body) catheter (or other input port and/or output port member) are an exemplary extracorporeal loop. This is a subset of all possible placements, some placements are done through the peripheral loop and some placements are done through the central loop.
在本文中不同於提及一周邊循環系統中所使用而使用術語「周邊」。例如,導管(或其他輸入流埠及/或輸出流埠構件)可放置成與腔靜脈接觸或降低至降主動脈或髂動脈中而無需使用螢光透視。此等有時被視為中央系統之部分而非周邊循環系統。 The term "peripheral" is used in this article instead of referring to a peripheral circulatory system. For example, a catheter (or other input port and/or output port member) can be placed in contact with the vena cava or lowered into the descending aorta or iliac artery without the use of fluoroscopy. These are sometimes regarded as part of the central system rather than the peripheral circulatory system.
如本文中所使用,術語「全身灌注系統」指代經由一注入器構 件耦合至心臟中之血液之一系統,該注入器構件直接耦合至主靜脈饋送器至心臟,諸如腔靜脈(下腔靜脈或上腔靜脈)或髂靜脈。 As used herein, the term "whole body infusion system" refers to The component is coupled to one of the blood systems in the heart, and the injector member is directly coupled to the main venous feeder to the heart, such as the vena cava (inferior vena cava or superior vena cava) or the iliac vein.
如本文中所使用,術語「局部灌注系統」指代具有經放置使得所注入之血流之一主要部分(大於約50%)在透過一般循環返回至心臟之前饋送至一器官系統之一注入器構件之一系統。 As used herein, the term "local perfusion system" refers to an injector that has been placed so that a major portion (greater than about 50%) of the injected blood flow is fed to an organ system before returning to the heart through the general circulation A component system.
如本文中所使用,術語「近端外部傳導」意謂著在器件之外部之空間中(即,在器件與脈管壁之間)且沿注入構件尖端之近端之一區之傳導。 As used herein, the term "proximal external conduction" means conduction in a space outside the device (ie, between the device and the vessel wall) and along a region of the proximal end of the tip of the injection member.
如本文中所使用,術語「遠端外部傳導」意謂著從一注入構件之尖端處之注入位點至遠端脈管中之總傳導。對於脈管之動脈側上之注入構件,此為從該尖端至循環之靜脈側之傳導。 As used herein, the term "distal external conduction" means the total conduction from the injection site at the tip of an injection member to the distal vessel. For the injection member on the arterial side of the vessel, this is the conduction from the tip to the venous side of the circulation.
如本文中所使用,術語「控制分流系統」為用於量測或計算近端外部傳導及遠端外部傳導之任一者或兩者之值、接著使用該等量測以藉由修改一注入構件處之注入流率來防止在該注入器構件之近端之區中之死流區域之一系統。如本文中所使用,此一系統由至少兩個壓力感測器及在該注入器構件之體外環路側上透過該注入器構件直接控制流率之一排量或流率控制泵組成。在本文中之任何實例中,該控制分流系統可包含一分佈式壓力感測器陣列。 As used herein, the term "control shunt system" is used to measure or calculate the value of either or both of the near-end external conduction and the far-end external conduction, and then use these measurements to modify an injection The injection flow rate at the component prevents a system of dead-flow areas in the region of the proximal end of the injector component. As used herein, this system consists of at least two pressure sensors and a displacement or flow rate control pump that directly controls the flow rate through the injector member on the extracorporeal loop side of the injector member. In any of the examples herein, the control shunt system may include a distributed pressure sensor array.
如本文中所使用,術語「流率模式」指代在一設定時間週期內流率之一函數形式。例如,流體流可設定於一流體流率源處使得該流體流遵循由該流率模式設定之值。在各項實例中,該流率模式可為一指定函數形式,諸如但不限於一正弦函數形式、一鋸齒函數形式、一階梯函數之函數形式或此項技術中之另一週期性函數形式(包含更複雜函數形式)。在其中該流率模式具有一不規則函數形式之其他實例中,可在一指定時間週期內依規則時間間隔量測流率值以提供該不規則函數形式之一近似值。 As used herein, the term "flow rate mode" refers to a function of the flow rate within a set period of time. For example, the fluid flow can be set at a fluid flow rate source such that the fluid flow follows the value set by the flow rate pattern. In various examples, the flow rate pattern may be a specified function form, such as but not limited to a sine function form, a sawtooth function form, a step function form or another periodic function form in the art ( Contains more complex functional forms). In other examples where the flow rate pattern has an irregular function form, the flow rate value can be measured at regular time intervals within a specified time period to provide an approximate value of the irregular function form.
在本文中之非限制性實例中,一外加最小傳導組件可經結構設計以在一注入構件之一遠端區周圍設定一已知的指定近端傳導。該近端傳導可防止任何無流或死流區域之形成。作為另一實例,在根據本文中之原理之一控制分流系統中,量測存在於一注入構件之近端外部中之傳導(而非產生該傳導)且使用該量測來控制相關區域(包含任何無流或死流區域)之流率及沖洗。 In the non-limiting example herein, an additional minimal conduction component can be structurally designed to set a known designated proximal conduction around a distal region of an injection member. This proximal conduction prevents the formation of any no-flow or dead-flow areas. As another example, in a control shunt system according to one of the principles in this paper, the conduction existing in the proximal exterior of an injection member (rather than generating the conduction) is measured and the measurement is used to control the relevant area (including Any area with no flow or dead flow) flow rate and flushing.
在本文中之一實例中,一「偏置閥」指代一內部管腔與暴露於脈管之軸件之外部之間的一導管段之壁中之一組件。在一實例中,「偏置閥」可經結構設計使得若該管腔內之壓力大於軸件外之壓力,則存在跨該閥建立之傳導Gforward之一值。在另一實例中,「偏置閥」可經結構設計使得若該管腔內之壓力小於軸件外之壓力,則存在跨該閥建立之傳導Gbackward之一值。在一實例中,該管腔與該脈管之間的合理壓力差可表示為Gforward>>Gbackward,或Gbackward極小或近於零。 In an example herein, a "offset valve" refers to a component in the wall of a catheter section between an inner lumen and the outside of the shaft exposed to the vessel. In one example, the "biased valve" can be structurally designed such that if the pressure in the lumen is greater than the pressure outside the shaft, there is a value of the conduction G forward established across the valve. In another example, the "bias valve" can be structurally designed so that if the pressure in the lumen is less than the pressure outside the shaft, there is a value of the conduction G backward established across the valve. In an example, the reasonable pressure difference between the lumen and the vessel can be expressed as G forward >> G backward , or G backward is very small or close to zero.
圖1A展示包含安置於脈管之一部分中之一軸件101之一例示性導管系統100之一示意圖。圖1A亦展示穿過安裝於軸件101上之一閉塞組件103之一平面102。軸件101可包含一管腔。在一例示性導管系統100中,閉塞組件103可包含使用鹽水或其他溶液充氣之一氣囊。另一例示性閉塞組件103可包含經膨脹以使用藉由一彈簧或其他機械致動施加之力擠壓動脈壁之一膜。在一實例中,閉塞組件103可經結構設計以從導管系統100之軸件101延伸以接觸並密封動脈或靜脈之壁,以明顯減少或防止流動。如圖1A中所展示,例示性平面102垂直於動脈區段。根據本文中之原理,例示性閉塞組件103用來修改跨平面102之流體流。該流體流係關於保持軸件之基座外之流。流動程度受閉塞組件103前方之區(Pb)與閉塞組件103後方之區(Pa)之間的一壓力差驅使。
Figure 1A shows a schematic diagram of an
圖1B及圖1C展示在跨穿過閉塞組件103之平面102之脈管空間中
流體傳導(G0)對時間之例示性圖表。圖1B展示對於使用閉塞組件103實現之一完全閉塞之流體傳導(G0)對時間。在圖1B之實例中,在該閉塞組件經啟動以完全閉塞脈管空間之時間週期△t期間,流體傳導減小。圖1B之圖表展示,在閉塞組件103經啟動用於完全閉塞時流體傳導變為零。此定義獨立於壓力梯度/差(F=G(Pa-Pb))。圖1C之圖表描繪在一經控制部分閉塞期間流體傳導(G0)對時間之條件,其中在一時間週期△t期間啟動根據本文中之原理之一閉塞組件。如圖1C中所展示,傳導不變為零而是變為具有大於零之量值之一最小傳導位準。
1B and 1C show exemplary graphs of fluid conduction (G 0 ) versus time in the vascular space across the
一導管可部署於脈管中之各種目標位置中。然而,極難在目標位置處精確地控制脈管之直徑。若不存在閉塞元件或未部署閉塞元件,則洩流可較大,且洩流可接著阻止順(遠端區)流體流之最佳控制。此受到流體在較大直徑動脈中較大且在動脈較小之情況下流體較小之約束。另一方面,一完全閉塞可導致形成一死區域。根據本文中之原理,可結合閉塞組件使用一小的經控制洩流結構,使得該死區域經沖洗但洩漏受限,使得其不會因使用該器件而對遠端流之有價值控制出錯。對於類似於頸動脈或股動脈中之血流之一流率,一200至500ml/min之順流率將極有用,但一20至50ml/min之沖洗流率或甚至更小可適於沖洗該死區域。 A catheter can be deployed in various target locations in the vessel. However, it is extremely difficult to accurately control the diameter of the vessel at the target location. If there is no occlusion element or the occlusion element is not deployed, the leakage flow can be greater, and the leakage flow can then prevent optimal control of the cis (distal zone) fluid flow. This is constrained by the larger fluid in larger diameter arteries and smaller fluid in smaller arteries. On the other hand, a complete occlusion can lead to the formation of a dead zone. According to the principle in this article, a small controlled drainage structure can be used in combination with the occlusion component, so that the dead area is flushed but the leakage is limited, so that it will not make mistakes in the valuable control of the distal flow due to the use of the device. For a flow rate similar to the blood flow in the carotid artery or femoral artery, a downstream flow rate of 200 to 500 ml/min will be very useful, but a flushing flow rate of 20 to 50 ml/min or even less can be suitable for flushing the dead area .
如本文中所述,最小傳導位準可為一固定常數或一固定平均值。對於固定常數,流體傳導G0隨時間推移保持恆定。對於固定平均值,在小於總器件啟動時間之一時間標度t上,最小傳導可係時變的。在一實例中,一偏置閥可經結構設計以實現該經控制部分閉塞,使得傳導隨著一心跳變化。在此實例中,「固定平均值」指代在一心跳之時間循環期間值發生變化但隨著該心跳具有一非零平均值之一流體傳導。此導致在較長時間週期內有一非零平均流體傳導。 As described herein, the minimum conduction level can be a fixed constant or a fixed average value. For a fixed constant, the fluid conducting passage G 0 remains constant over time. For a fixed average value, the minimum conduction can be time-varying on a time scale t less than the total device startup time. In one example, a bias valve may be structurally designed to achieve the controlled partial occlusion, so that conduction changes with a heartbeat. In this example, "fixed average value" refers to a fluid conduction that changes during the time cycle of a heartbeat but has a non-zero average value with the heartbeat. This results in a non-zero average fluid conduction over a longer period of time.
在一實例中,外加最小傳導依一固定常數形式實現。定位於一 體外注入構件之遠端尖端處之一外加最小傳導組件經結構設計以維持一最小傳導,該最小傳導提供一流體流以沖洗否則將因任何完全閉塞而產生之死區域。該最小傳導之流阻方面之大小經設定使得沖洗流不大於該器件用來透過注入器構件引導之流之約50%,或較佳地不大於約10%。 In one example, the additional minimum conduction is realized in the form of a fixed constant. Located at one One of the extra-minimal conduction components at the distal tip of the extracorporeal injection member is structurally designed to maintain a minimum conduction that provides a fluid flow to flush out dead areas that would otherwise be caused by any complete occlusion. The magnitude of the minimum conduction flow resistance is set so that the flushing flow is no greater than about 50%, or preferably no greater than about 10%, of the flow that the device uses to guide through the injector member.
在一實例中,外加最小傳導依一被動形式實現。一例示性閉塞元件經結構設計以包含一替代流體旁通路徑,從而允許一旁通流沖洗否則將因閉塞而產生之死區域。該旁路之流阻方面之大小經設定使得旁通流不大於該器件用來透過注入器構件引導之流之約50%,或較佳地不大於約10%。 In one example, the additional minimum conduction is realized in a passive form. An exemplary occlusion element is structurally designed to include an alternative fluid bypass path, allowing a bypass flow to flush out dead areas that would otherwise be caused by occlusion. The size of the flow resistance of the bypass is set so that the bypass flow is not greater than about 50%, or preferably not greater than about 10%, of the flow that the device uses to guide through the injector member.
在一些實例中,閉塞組件可包含待用於閉塞之軟氣囊。在一實例中,軟氣囊可經部分充氣,從而導致一定的洩漏傳導。此可有用,因為脈管不均勻且在一部分充氣下之洩漏傳導量對使用者不可見及/或係可控制的。 In some examples, the occlusion component may include a soft bladder to be used for occlusion. In one example, the soft airbag may be partially inflated, resulting in some leakage conduction. This can be useful because the vessel is not uniform and the amount of leakage conduction under partial inflation is invisible to the user and/or controllable.
圖2A展示耦合至一個人之一例示性體外環路200之一示意圖。例示性體外環路200包含一泵系統206、一熱交換器208及一注入器構件210。一例示性體外環路可包含至一患者之脈管之兩個連接件。此一例示性體外環路可經實施以使用一個連接件從脈管泵送血液且使用另一連接件將血液返回至脈管。一例示性體外環路可在其中心臟不起作用或不供應足夠血流之情況下被使用,或可用來修改血液且將血液返回至全身血流或一局部區域。其他修改可包含氧化、透析、熱化、移除細菌污染物、移除致癌細胞等。圖2A展示在脈管注入點212處耦合至一個人之身體之脈管以基於使用泵系統206調變之一流率將血液214返回至身體之注入器構件210。脈管中之最遠端位置(血液在該位置處注入至身體中)在本文中稱為「脈管注入點」。
Figure 2A shows a schematic diagram of an exemplary
在一實例中,注入器構件210可包含用來使一側上之血流與在另
一側上由一體外環路注入通過器件軸件之流體分離之一閉塞組件。此可在脈管之一部分中產生一無流或受限流區域,即,一死區域。若一閉塞系統相對於最近脈管分支位於一確切位置處,則可避免該死區域,但在實踐時,在真實患者中不可保證此一確切放置。因此,一死區域常形成於包含注入點、血液不流動之分支中。若閉塞保留在原處達長時間週期,則此可潛在地導致形成血栓或血塊。可使用體外血液供應環路達長時間週期(諸如但不限於為小時至天之級別之時間),此時間可足以增大形成血栓或血塊之風險。
In one example, the
圖2B展示一例示性注入器構件210,其為圖2A之例示性體外環路系統之一組件且將血液返回至身體脈管注入點212中之一特定位置。通過軸件管腔之注入流體216可添加至此分支中之血流。當達到替代血流被阻擋之程度時,經注入之血液可支配遠端脈管中之流。
2B shows an
圖2C展示一例示性注入器構件210,其為圖2A之例示性體外環路系統之一組件且將血液(注入流體216)返回至身體中之一特定位置。注入器構件210耦合至被展示為使脈管之一部分完全閉塞之一閉塞組件203。如圖2C中所展示,在注入器構件210透過閉塞器件203於一脈管注入點處注入血液時,可在閉塞組件203之近端形成一死區域205。
2C shows an
圖3A至圖3B展示根據本文中之原理之例示性外加最小傳導系統。圖3A之外加最小傳導系統包含一管腔320,該管腔320具有一離散長度l,沿該器件之軸件安置且在一組件321(諸如但不限於一軟氣囊321)下方,使得其對用來沖洗死區域之流提供一最小傳導。受設計長度及直徑控制之此一管腔320可使流體呈現一恆定流率且因此允許一小旁通流。圖3A展示通過管腔320之正向新沖洗流324。圖3B展示通過管腔320之反向沖洗流326(逆沖洗流)。圖3A至圖3B中之虛線用來展示血流328之方向。在圖3A及圖3B兩者中,流動通過最小傳導之流體可用來沖洗在組件321之近端之死區域,藉此防止或最小化不必
要的血栓形成。
Figures 3A to 3B show an exemplary additional minimum conduction system according to the principles herein. The minimal conduction system in addition to FIG. 3A includes a
圖4A至圖4B展示根據本文中之原理之另一例示性外加最小傳導系統。圖4A至圖4B展示包含在該器件之軸件中且正好在組件421(諸如但不限於一氣囊)之近端之一或多個孔或孔口430之例示性外加最小傳導系統,而非在外加最小傳導組件下方之額外管腔(如圖3A至圖3B所示)。在此等例示性系統中,該器件朝向其遠端尖端引導之流424之一部分在達成閉塞之前透過一或多個孔(或孔口)430漏出。圖4A亦展示血流428之方向。圖4A繪示在壓力Pb之值小於壓力Pa時之一實例,其導致一反向沖洗流(被繪示為流424)。圖4B展示其中Pb相對於Pa足夠大使得形成一正向沖洗流426之一案例之一例示性外加最小傳導系統。
4A to 4B show another exemplary additional minimum conduction system according to the principles herein. 4A to 4B show an exemplary additional minimal conduction system included in the shaft of the device and just at the proximal end of the component 421 (such as, but not limited to, an airbag) one or more holes or
圖4C展示根據本文中之原理之另一例示性外加最小傳導系統。該例示性外加最小傳導系統包含包含一或多個孔(或孔徑)431之一外加最小傳導組件(一彈簧驅動膜440)。一或多個孔(或孔徑)431用來控制流體流,且提供最小傳導。在圖4C之例示性外加最小傳導系中,繪示膜440之截面。然而,膜440包含繞著該器件軸件對稱部署(類似於一傘之部署)之一或多個實質上固態的膜部分。圖4C亦展示透過外加最小傳導組件之一或多個孔(或孔徑)431漏出之血流428及流體流442之部分之方向。
Figure 4C shows another exemplary additional minimal conduction system according to the principles in this paper. The exemplary additional minimum conduction system includes one of one or more holes (or apertures) 431 plus a minimum conduction component (a spring driven membrane 440). One or more holes (or apertures) 431 are used to control fluid flow and provide minimal conduction. In the exemplary external minimum conduction system of FIG. 4C, the cross section of the
圖4D(i)及圖4D(ii)展示根據本文中之原理之其他例示性外加最小傳導系統。圖4D(i)之例示性系統包含包含將脈管密封於氣囊葉之間以提供最小傳導之間隙之一多葉軟氣囊(或其他結構化氣囊)450。在各項實例中,多葉軟氣囊(或其他結構化氣囊)450可形成有兩個、三個或更多個氣囊。圖4D(ii)展示一多葉軟氣囊(或其他結構化氣囊)450之不同實例之截面圖(穿過圖4D(i)中所展示之線A-A')。作為非限制性實例,該外加最小傳導系統可包含包含間隙460之一雙葉軟氣囊(或其
他雙葉結構化氣囊)455或包括間隙470之一三葉軟氣囊(或其他三葉結構化氣囊)465。
Fig. 4D(i) and Fig. 4D(ii) show other exemplary additional minimal conduction systems according to the principles herein. The exemplary system of FIG. 4D(i) includes a multi-leaf soft balloon (or other structured balloon) 450 that includes a gap that seals the vessel between balloon lobes to provide minimal conduction. In various examples, the multi-leaf soft airbag (or other structured airbag) 450 may be formed with two, three, or more airbags. Figure 4D(ii) shows a cross-sectional view of different examples of a multi-leaf soft airbag (or other structured airbag) 450 (crossing the line AA' shown in Figure 4D(i)). As a non-limiting example, the additional minimal conduction system may include a two-leaf soft airbag containing a gap 460 (or
He double-leaf structured airbag) 455 or a three-leaf soft airbag (or other three-leaf structured airbag) 465 that includes a
圖5A(i)至圖5C展示根據本文中之原理之其他例示性外加最小傳導系統。在圖5A之例示性系統中,一偏置閥用來添加對至最小傳導之沖洗流之方向之控制。因此,方向性可在由跨構件之壓力差支援之方向上產生一固定常數流。作為一實例,脈管中之壓力差可使得歸因於各心跳變更符號而在注入點處有血壓偏移,即,基於收縮/舒張壓變動從一正壓值至一負值之變更。該例示性外加最小傳導系統可經結構設計使得基於壓力差之符號(即,方向),沖洗流可在心跳循環之僅一部分期間「起作用」,從而實現一「固定平均」最小傳導而非一「固定常數」最小傳導。 Figures 5A(i) to 5C show other exemplary additional minimal conduction systems according to the principles herein. In the exemplary system of Figure 5A, a bias valve is used to add control to the direction of the flush flow to minimum conduction. Therefore, the directionality can produce a fixed constant flow in the direction supported by the pressure difference of the span member. As an example, the pressure difference in the vessel may cause a blood pressure shift at the injection point due to each heartbeat change sign, that is, a change from a positive pressure value to a negative value based on the systolic/diastolic pressure change. The exemplary additional minimum conduction system can be structurally designed so that based on the sign (ie, direction) of the pressure difference, the flushing flow can "work" during only a portion of the heartbeat cycle, thereby achieving a "fixed average" minimum conduction instead of one "Fixed constant" minimum conduction.
圖5A(i)展示在包含一組件521(諸如但不限於一軟氣囊)之一導管管腔中之一孔徑上包含一偏置閥510之一例示性外加最小傳導系統。參數Pin及Pout為管腔內之壓力及軟氣囊521之近端外之壓力值。在此實例中,遠端區為其中流率及壓力受經過管腔且透過遠端尖端注入之流支配之區。大體言之,若Pout受心臟驅使,則Pout之值具有類似於心跳之一循環,從而在各循環中達成一局部最大值及最小值。圖5A(ii)展示可在圖5A(i)之例示性系統中實施之一例示性偏置閥。圖5A(ii)展示安裝至一導管之軸件之部分之一例示性偏置閥510,其具有將軸件之內管腔耦合至外界之一孔及大於該孔且錨固於至少一側上覆蓋該孔之一撓性塑膠皮瓣。該例示性偏置閥經結構設計使得一正壓差(軸件內之壓力大於軸件外之壓力)可導致該撓性塑膠皮瓣打開,從而允許流體向外流動,且一負壓差(軸件內之壓力低於軸件外之壓力)可導致該撓性塑膠皮瓣閉合且密封該孔之邊緣,從而阻擋流體向內流動。
Figure 5A(i) shows an exemplary additional minimal conduction system that includes a
圖5B展示包含耦合至一組件521之一偏置閥532之一例示性外加最小傳導系統。偏置閥532包含經結構設計以打開且允許流體流出注
入構件之中央管腔但不允許流動至該管腔中之一皮瓣。即,在壓力Pb之值低於壓力Pa時,偏置閥532允許流534,此在心跳循環之某些時間間隔期間發生。圖5B展示通過偏置閥532之皮瓣之流534之部分及血流538之方向。在此實例中,從體外環路注入至身體中之血液之僅一小部分用來沖洗死區域(即,通過該偏置閥之流534)。
FIG. 5B shows an exemplary additional minimal conduction system including a
圖5C展示在一旁通管腔542之一端上包含充當一偏置閥540之一皮瓣之一例示性外加最小傳導系統。類似於圖3A或圖3B中所展示之外加最小傳導系統,管腔542具有一離散長度l,並且沿注入器構件之軸件安置且在組件521下方。偏置閥540及旁通管腔542之耦合動作對流提供一最小傳導以沖洗死區域(或低流區域)。圖5C展示通過偏置閥540之皮瓣之流544之部分及血流548之方向。偏置閥540之皮瓣可安裝於旁通管腔542之近端或遠端上,藉此允許藉由設計選擇沖洗流之方向。即,若經結構設計以僅允許向外流體傳導之一皮瓣安裝於管腔542之近端處(如圖5C中所展示),則遠端注入之血液回流進行沖洗。若該皮瓣安裝於管腔542之遠端處,則來自分支之正常血流正向沖洗且在脈管注入點處與該經注入之血流混合。詳細操作部分由Pb(管腔542前方之壓力)與Pa(管腔542後方之壓力)之間的經施加壓力差決定,此係因為偏置閥可經結構設計以僅允許在一個方向上流動。若壓力Pa及Pb之值足夠接近使得隨心跳之收縮/舒張壓變更引起之Pb變更導致該偏置閥在各心臟循環中之某些時間間隔期間打開,則此例示性實施將係有利的。
Figure 5C shows an exemplary additional minimal conduction system that includes a flap on one end of a
根據本文中之原理,一例示性外加最小傳導組件或包含一外加最小傳導組件之一例示性系統可用於提供選擇性熱治療。該例示性外加最小傳導組件可耦合至經結構設計以應用一選擇性熱治療之任何系統。在任何例示性實施中,可使用根據本文中之原理之外加最小傳導組件來取代常用阻塞元件。該外加最小傳導組件可安置於供該系統之 一注入器構件用於應用該選擇性熱治療之至少一個注入器構件之遠端尖端之近端。作為非限制性實例,根據本文中之原理之一外加最小傳導組件可耦合至此項技術中之應用選擇性熱治療之任何系統,諸如美國專利第7,789,846 B2號或國際(PCT)申請案第PCT/US2015/033529號中所揭示之系統。 According to the principles in this article, an exemplary additional minimal conduction component or an exemplary system including an additional minimal conduction component can be used to provide selective thermal therapy. This exemplary additional minimal conductive component can be coupled to any system that is structurally designed to apply a selective thermal treatment. In any exemplary implementation, the usual blocking element can be replaced by a minimal conductive component in addition to the principles herein. The additional minimum conductive components can be placed on the An injector member is used to apply the selective thermal treatment to the proximal end of the distal tip of at least one injector member. As a non-limiting example, according to one of the principles herein plus the smallest conductive component can be coupled to any system applying selective thermal therapy in this technology, such as US Patent No. 7,789,846 B2 or International (PCT) Application No. PCT/ The system disclosed in US2015/033529.
在本文中之任何實例中,該外加最小傳導組件可形成有一無創傷表面、一親水塗層、或一藥物塗層或其任何組合。 In any of the examples herein, the additional minimally conductive component can be formed with an atraumatic surface, a hydrophilic coating, or a drug coating or any combination thereof.
圖6A展示本發明之一例示性控制分流系統。該例示性控制分流系統包含一第一壓力感測器610及一第二壓力感測器612。第一壓力感測器610可安置於一導管之注入器構件614之尖端之近端,且第二壓力感測器612可依與一操作者之近端相隔如從尖端(或從壓力感測器610)量測之一預界定間距(△)安置於注入器構件614上。作為非限制性實例,預界定間距(△)可為約2cm、約5cm、約8cm、約12cm、約15cm、約20cm、約25cm或約30cm。在各種非限制性實例中,壓力感測器610及612之一者或兩者可實施為嵌入於導管壁中之矽基感測器(具有電子(有線)讀出)或使用該導管壁中之管腔中之光纖以將讀出提供給該導管之近端處之適當計算介面系統之光纖基壓力感測器。在另一例示性實施方案中,壓力感測器610及612之一者或兩者經結構設計以使用:一簡單壁管腔,其在如圖6A中所繪示之位置處具有遠端開口且填充有一不可壓縮流體;及一外部壓力感測器,其安裝於該導管之近端處之一流體連接器上以量測由該管腔之液柱傳導之靜態或低頻壓力。壓力感測器610可經結構設計以量測在尖端(Ptip)之近端之壓力且壓力感測器612可經結構設計以量測在注入器構件614之近端之壓力(Pb)。圖6A亦展示在該導管附近依流率Fb之血流及在該注入器構件之尖端處依流率Ftip之經注入血流之方向。
Figure 6A shows an exemplary control shunt system of the present invention. The exemplary control shunt system includes a
亦如圖6A中所展示,該導管可耦合至一體外系統之一流率源
616。在一例示性實施方案中,流體可係容積流驅動而非壓力驅動的。在流體(Ftip)透過尖端注入至脈管中時,其與來自上游之流體(Fb)混合且流動通過下游傳導Gtip。在圖6A中展示上游流經過傳導Gb,如出現於動脈(或靜脈)壁與導管之間的空間中。可能難以直接量測或預測傳導Gb之一值。甚至在壓力感測器610及612經安置以量測Ptip及Pb之情況下,若Gb係未知的,則仍可能難以直接量測Fb。根據本文中之原理之例示性系統及方法可用於判定Gb之一值。
As also shown in Figure 6A, the catheter can be coupled to a
在一實例中,該流率源可用來控制一容積流率。該例示性流率源可為但不限於一排量泵、一注射器泵或一旋轉泵。 In one example, the flow rate source can be used to control a volume flow rate. The exemplary flow rate source can be, but is not limited to, a displacement pump, a syringe pump, or a rotary pump.
在一實例中,該流率源可用來控制流率,使得於遠端尖端處注入之流體隨著一系列容積衝量流動。在此實例中,可根據一階梯函數模型化該系列容積衝量。該流率源可為執行來自一控制台之一處理單元之指令以遞送該系列衝量中之衝量之各者之一泵,或基於來自該控制台之一第一信號起始且連續遞送階梯函數衝量直至來自該控制台之一第二信號導致該泵停止操作之一泵。 In one example, the flow rate source can be used to control the flow rate so that the fluid injected at the distal tip flows with a series of volume impulses. In this example, the series of volume impulses can be modeled according to a step function. The flow rate source may be a pump that executes instructions from a processing unit of a console to deliver each of the impulses in the series, or a step function initiated and continuously delivered based on a first signal from the console Impulse until a second signal from the console causes the pump to stop operating a pump.
在其他實例中,該流率源可用來控制流率,使得流體根據其他類型之函數形式(諸如但不限於一正弦函數形式、鋸齒函數形式或其他循環函數形式)流動。 In other examples, the flow rate source can be used to control the flow rate so that the fluid flows according to other types of functional forms (such as but not limited to a sine function form, a sawtooth function form, or other cyclic function form).
在本文中之任何實例中,該流率源可用來控制流率以建立流率模式。如上文所述,該流率模式可基於一任意波形或其他類型之函數形式,諸如但不限於一正弦函數形式、鋸齒函數形式或其他循環函數形式。 In any example herein, the flow rate source can be used to control the flow rate to establish a flow rate pattern. As mentioned above, the flow rate mode can be based on an arbitrary waveform or other types of function forms, such as but not limited to a sine function form, a sawtooth function form, or other cyclic function forms.
在根據圖6A之原理之一非限制性實例中,一注入器構件耦合至兩個壓力感測器,其中該注入器構件由一外部流率控制構件驅動以允許量測或計算近端外部傳導及遠端外部傳導之值。例示性系統使得能夠從指示壓力量測之資料推斷導管之注入器構件周圍之流。 In a non-limiting example according to the principle of FIG. 6A, an injector member is coupled to two pressure sensors, wherein the injector member is driven by an external flow rate control member to allow measurement or calculation of proximal external conduction And the value of remote external conduction. The exemplary system enables the flow around the injector member of the catheter to be inferred from the data indicative of the pressure measurement.
提供用於判定兩個傳導之一控制分流系統,包含圖6A中所繪示之系統。第一傳導(稱為近端傳導(Gb))為由兩個壓力感測器610及612界定之平面之間的導管外之脈管空間中之傳導。第二傳導(稱為遠端傳導(Gtip))為從尖端至返回至核心系統(或在一流動意義上為接地)之血液之傳導。在無量測之情況下,此兩個傳導通常不可推斷,此係因為計算將使用指示區域脈管之大小及形狀之資料。在Gtip之情況下,計算將使用指示脈管床座之狀態及/或損害程度之資料。此兩個傳導之值之知識可提供臨床效益,此係因為其等表示患者之脈管舒張/脈管收縮之局部狀態之一量測。使用壓力感測器610及612來量測Ptip及Pb,若其等之間的傳導為如先前所述之外加最小傳導之一控制傳導,則可使用流Fb=Gb(Pb-Ptip)估計該流。在其中Gb之計算包含指示靜脈或動脈之表面之資料之一例示性實施方案中,不可事先判定Gb。大體言之,無法在涉及注入構件放置之一操作或其他醫療程序之前判定Gtip。
Provides a control shunt system for determining one of the two conductions, including the system shown in Figure 6A. The first conduction (referred to as proximal conduction (G b )) is conduction in the vascular space outside the catheter between the plane defined by the two
本文中提供用於計算在一操作或其他醫療程序期間一患者之在體Gb及Gtip兩者之例示性系統及方法。使用一線性近似法,可使用兩個方程式表示使注入構件之遠端尖端周圍之流平衡,如下:(1)....Fb=Gb(Pb-Ptip) Provided herein are exemplary systems and methods for calculating both the on-body G b and G tip of a patient during an operation or other medical procedure. Using a linear approximation method, two equations can be used to balance the flow around the distal tip of the injection member, as follows: (1)...F b =G b (P b -P tip )
(2)....(Fb+Ftip)=Gtip(Ptip)可從泵(諸如但不限於流率源616)設定Ftip之值。圖6A之例示性系統可用來量測壓力Pb及壓力Ptip之值。使用此等值,方程式可縮減為:(3)....Gtip=Ftip/Ptip+Gb(Pb-Ptip)/Ptip其中Gtip及Gb係未知數。在使用注入構件以將血液返回至身體之一操作或其他醫療程序期間,在時間To之初始注入流可用作F’tip(作為一非限制性實例,約250ml/min)。在時間T1,流值可變更至F”tip(作為一非限制性實例,約275ml/min,一10%增大)。在時間T0及T1之流之 此等非限制性的例示性值可經挑選以落於注入點處之特定骨骼及特定臨床應用之一所要臨床範圍內。圖6A之例示性系統可用來量測在時間點T0之壓力Pb及壓力Ptip之值(P’b及P’tip)以及在時間點T1之壓力Pb及壓力Ptip之值(P”b及P”tip)。使用方程式(3)中之四個不同壓力值及兩個不同注入流值,即,在時間T0引入F’tip、P’tip、P’b及在時間T1引入F”tip、P”tip及P”b,產生兩個(2)方程式,各方程式具有兩個(2)未知數。此等方程式可用來計算Gb及Gtip之值。容易為一般技術者顯所易見的是,方程式(1)、(2)及(3)為關於一脈管區中之流、傳導及壓力之方程式之非限制性實例。其他方程式(包含更複雜版本之方程式)可係適用的。例如,其中傳導不獨立於壓力但自身為一壓力函數之方程式亦可藉由以下步驟予以處理:在經應用流Ftip之不同值下使用重複壓力量測以建立更多方程式且允許對為線性或甚至二次或更高階壓力函數之傳導(G)之形式求解。 (2)... (F b + F tip )=G tip (P tip ) The value of F tip can be set from a pump (such as but not limited to the flow rate source 616). The exemplary system of Fig. 6A can be used to measure the values of pressure P b and pressure P tip . Using these equivalent values, the equation can be reduced to: (3)...G tip =F tip /P tip +G b (P b -P tip )/P tip where G tip and G b are unknown numbers. During an operation or other medical procedure using the injection member to return blood to the body, the initial injection flow at time To can be used as the F'tip (as a non-limiting example, about 250 ml/min). At time T 1 , the flow value can be changed to F” tip (as a non-limiting example, about 275 ml/min, a 10% increase). Such non-limiting examples of the flow at time T 0 and T 1 The performance value can be selected to fall within the clinical range required by one of the specific bones at the injection point and the specific clinical application. The exemplary system of Figure 6A can be used to measure the values of pressure P b and pressure P tip at time T 0 (P' b and P'tip ) and the values of pressure P b and pressure P tip at time point T 1 (P” b and P” tip ). Use four different pressure values and two in equation (3) different injection flow values, i.e., F is introduced at time T 0 'tip, P' tip , P 'b 1 and is introduced at time T F "tip, P" tip and P "b, generates two (2) equations, each The equation has two (2) unknowns. These equations can be used to calculate the values of G b and G tip . It is easily obvious to those skilled in the art that equations (1), (2) and (3) are non-limiting examples of equations for flow, conduction and pressure in a vascular area. Other equations (including more complex versions of equations) may be applicable. For example, an equation in which conduction is not independent of pressure but itself a pressure function can also be processed by the following steps: using repeated pressure measurements at different values of the applied flow F tip to create more equations and allow the pair to be linear Or even the form of the conduction (G) of the second or higher order pressure function.
如本文中所述,流率源可用來控制流率使得於遠端尖端處注入之流體根據一階梯函數或其他類型之函數形式(諸如但不限於一正弦函數形式、鋸齒函數形式或其他循環函數形式)流動。在其他實例中,流率可基於對流體流之一回應函數之量測予以模型化且對一適用函數形式求解。 As described herein, the flow rate source can be used to control the flow rate so that the fluid injected at the distal tip is based on a step function or other type of function form (such as but not limited to a sine function form, a sawtooth function form or other cyclic function Form) flow. In other examples, the flow rate can be modeled based on the measurement of a response function of the fluid flow and solved in a suitable functional form.
本文中提供用於計算在一冗長操作或其他醫療程序期間一患者之在體Gb及Gtip兩者之例示性系統及方法。作為一非限制性實例,此一冗長操作(或其他醫療程序)可持續達小時或天之級別。一例示性方法可包含在操作或其他醫療程序期間依規則的重複循環將一階梯變更應用於Ftip(即,從一基準之一離散值變更)達一短時間間隔(t 1 )。作為一非限制性時間,在操作或其他醫療程序之每小時之前5分鐘內(即,t 1 =5分鐘),該階梯變更可應用於Ftip。在時間間隔t 1 結束時,Ftip之值返回至基準值。用於修改Ftip之值之此例示性方法可用於在冗長操作 或其他醫療程序期間使用本文中所述之方法量測每小時之Gb及Gtip。此等例示性系統及方法臨床應用於監控脈管狀態(脈管舒張/脈管收縮)或偵測血栓形成之程序或血栓溶解之時間。 Provided herein are exemplary systems and methods for calculating both the in vivo G b and G tip of a patient during a lengthy operation or other medical procedure. As a non-limiting example, this lengthy operation (or other medical procedure) can last up to hours or days. An exemplary method may include applying a step change to F tip (ie, a discrete value change from a reference) for a short time interval ( t 1 ) in a regular repetitive cycle during operation or other medical procedures. As a non-limiting time, within 5 minutes before each hour of an operation or other medical procedure (ie, t 1 =5 minutes), the step change can be applied to F tip . At the end of the time interval t 1 , the value of F tip returns to the reference value. This exemplary method for modifying the value of F tip can be used to measure hourly G b and G tip during lengthy operations or other medical procedures using the methods described herein. These exemplary systems and methods are clinically applied to monitor vascular status (vasodilation/vasoconstriction) or to detect the procedure of thrombus formation or the time of thrombus dissolution.
例示性系統及方法之另一例示性臨床應用如下。在一操作或其他醫療程序期間,運用對於Gb及Gtip計算之值,可從經量測之壓力Pb及Ptip判定沖洗在尖端之近端之空間之流Fb之數量。若流Fb落於一所要值範圍外,則可調整Ftip以調整Fb。 Another exemplary clinical application of the exemplary system and method is as follows. During an operation or other medical procedures, using the values calculated for G b and G tip , the amount of flow F b flushing the space near the tip can be determined from the measured pressures P b and P tip . If the flow F b falls outside a desired value range, F t i p can be adjusted to adjust F b .
系統及方法之另一臨床應用為施加於組織之血液之熱容量之判定。在操作或其他醫療程序期間,Fb及Ftip可混合於在尖端之遠端之區域中。若血流Fb處於一第一溫度且經注入之血流Ftip處於不同於該第一溫度之一第二溫度,則可直接計算施加於遠端區域中之組織之血液之熱容量且可使用經注入之血液之溫度之調整來補償溫或冷血流Fb。替代地,控制複溫之程序可藉由調整流比率Fb:Ftip以及其等溫度差來完成。在一操作或其他醫療程序期間,可應用用於量測本文中所述之Gb及Gtip之一例示性方法一次或多次。該方法可經泛化以使用Ftip之一個以上階梯變更,在此情況下操作者可量測Gb及Gtip之值以判定在方程式(1至3)之線性近似外其等可如何變化。一操作者可藉由例如以下步驟實施根據本文中之原理之一例示性方法:直接設定Ftip;記錄感測器記錄;及使用一計算器件來執行計算。在另一例示性實施方案中,本文中之一計算器件或系統可包含至少一個處理單元,該至少一個處理單元經程式化以執行處理器可執行指令,以導致一例示性系統之一控制器自動實施如本文中所述之用於量測Gb及Gtip之值之量測常式。該例示性系統可經結構設計以允許一使用者設定Ftip之一標稱值且執行處理器可執行指令以依所要時間間隔(諸如但不限於每隔30或45或60分鐘或其他時間間隔)執行Gb及Gtip之一自動量測。在本文中之任何實例中,該計算器件可為一控制台。 Another clinical application of the system and method is the determination of the heat capacity of the blood applied to the tissue. During operation or other medical procedures, F b and F tip can be mixed in the area at the distal end of the tip. If the blood flow F b is at a first temperature and the injected blood flow F tip is at a second temperature that is different from the first temperature, the heat capacity of the blood applied to the tissue in the distal region can be directly calculated and used The temperature of the injected blood is adjusted to compensate for the warm or cold blood flow F b . Alternatively, the process of controlling the reheating can be accomplished by adjusting the flow ratio F b : F tip and the temperature difference. During an operation or other medical procedure, one of the exemplary methods for measuring G b and G tip described herein can be applied one or more times. This method can be generalized to use more than one step change of F tip . In this case, the operator can measure the values of G b and G tip to determine how they can change beyond the linear approximation of equations (1 to 3) . An operator can implement one of the exemplary methods according to the principles in this text by, for example, the following steps: directly setting F tip ; recording sensor records; and using a computing device to perform calculations. In another exemplary implementation, a computing device or system herein may include at least one processing unit that is programmed to execute processor-executable instructions to cause a controller of an exemplary system The measurement routines used to measure the values of G b and G tip as described herein are automatically implemented. The exemplary system can be structured to allow a user to set a nominal value of F tip and execute processor-executable instructions at a desired time interval (such as but not limited to every 30 or 45 or 60 minutes or other time intervals). ) Execute one of G b and G tip automatic measurement. In any of the examples herein, the computing device can be a console.
圖6B展示根據本文中之原理之一例示性控制分流系統。該例示性系統包含結合一同心圓筒二埠導管使用以支援一獨立局部體外迴路之兩個壓力感測器。如圖6B中所展示,兩個壓力感測器610及612耦合至為同心軸件類型之一體外環路接入導管之部件之一***構件614。在該實例中,外軸件618將血液供應給體外環路200且內軸件614充當用來將血液返回至身體中之一位置之一***構件。圖6B亦展示外流至體外環路之血流之虛線615及一導管周圍之血流(Fb)之虛線617。作為非限制性實例,US 7,704,220及美國專利第7,789,846號揭示可在根據本文中之原理之一或多個例示性系統中實施之同心體外接入導管之實例。
Figure 6B shows an exemplary control shunt system according to one of the principles herein. The exemplary system includes two pressure sensors used in conjunction with a concentric cylindrical two-port catheter to support an independent local extracorporeal circuit. As shown in FIG. 6B, two
圖6C及圖6D展示根據本文中之原理之可用來計算在心臟之近端之脈管之一區中之傳導之值之例示性系統。在圖6C及圖6D之實例中,該例示性系統被展示為安置於主動脈弓之一區中。如圖6C中所展示,該例示性系統包含耦合至一導管構件620之壓力感測器610及612。在此實例中,壓力感測器量測可用來計算如本文中所述之傳導。在一實例中,使用壓力量測,可根據上文中所述之用於計算在體Gb及Gtip兩者之例示性方法計算傳導。在圖6C之實例中,可從導管構件620之一遠端尖端引入流體流。圖6D展示另一例示性系統,其類似於圖6C,但導管620包含允許來自導管構件620之一更居中區之流體流之一近端埠622。
Figures 6C and 6D show an exemplary system that can be used to calculate the value of conduction in a region of a vessel at the proximal end of the heart based on the principles herein. In the example of Figures 6C and 6D, the exemplary system is shown to be placed in a region of the aortic arch. As shown in FIG. 6C, the exemplary system includes
在本文中之任何例示性系統、方法、器件及裝置中,透過注入器構件注入之流體可與經過導管或器件周圍之外部空間之流體(外部流體)混合。若流體流混合,則其等在注入點之遠端之區中形成一混合流體(本文中亦稱為一混合遠端流)。若一已知濃度(以mg/ml或其他質量/容積單位為單位)之一藥物或藥劑添加至該經注入之流體,則在該遠端混合流體中之藥物或藥劑之濃度係未知的,除非外部流體流率 及經注入流體流率之比率係已知的。本文中所述之例示性系統可用來設定外部傳導(外加最小傳導組件)或定量外部傳導(控制分流系統)。基於傳導資料,可量測或計算外部流體流率。運用外部流體流率之經計算值及由耦合至注入器構件之泵系統(或其他系統)設定之經注入流率,添加至經注入流體之藥物或藥劑之濃度可經調整以在遠端流體混合物中實現所要藥物濃度。 In any of the exemplary systems, methods, devices, and devices herein, the fluid injected through the injector member can be mixed with the fluid (external fluid) passing through the catheter or the external space around the device. If the fluid streams are mixed, they will form a mixed fluid (also referred to herein as a mixed distal flow) in the region distal to the injection point. If a drug or drug of a known concentration (in mg/ml or other mass/volume unit) is added to the injected fluid, the concentration of the drug or drug in the remote mixed fluid is unknown, Unless the external fluid flow rate And the ratio of the injected fluid flow rate is known. The exemplary system described herein can be used to set external conduction (plus minimum conduction components) or to quantify external conduction (control shunt system). Based on the conduction data, the external fluid flow rate can be measured or calculated. Using the calculated value of the external fluid flow rate and the injected flow rate set by the pump system (or other system) coupled to the injector member, the concentration of the drug or medicament added to the injected fluid can be adjusted to flow at the distal end The desired drug concentration is achieved in the mixture.
在本文中之任何實例中,藥物或藥劑可為用來診斷、治癒、治療或防止一疾病之任何物質。例如,藥物或藥劑可包含一電解質溶液、奈米顆粒、生物製劑、小分子、大分子、聚合材料、生物製藥、或可用於血流之任何其他藥物或藥劑。 In any example herein, a drug or medicament can be any substance used to diagnose, cure, treat or prevent a disease. For example, the drug or medicament may include an electrolyte solution, nanoparticle, biological agent, small molecule, macromolecule, polymeric material, biopharmaceutical, or any other drug or medicament that can be used in the bloodstream.
根據本文中之原理之一例示性系統可用於提供選擇性熱治療之至少兩個區域。該例示性系統包含一體外環路。該例示性體外環路包含包含安置於一脈管位置處之一遠端尖端之一注入器構件及安置於該遠端尖端之近端之一外加最小傳導組件。該例示性系統亦可包含:一第一埠,其用來從身體抽取血液;一第二埠,其用來將血液返回至身體;一第一泵,其安置於該第一埠與該第二埠之間以將血液從該第一埠泵送至該第二埠;一分支區段,其定位於該第一泵與該第二埠之間;一第三埠,其耦合至該分支區段,該第三埠定位於該注入器構件之一體外側上;及一第二泵,其定位於該分支區段與該第三埠之間。該第二泵可經結構設計以控制透過該第三埠至該注入器構件中之在該分支區段外之一流率。該例示性系統亦可包含安置於該第一埠與該第二埠之間的一第一熱交換器及安置於該第二泵與該注入器構件之間的一第二熱交換器。該第一熱交換器可經結構設計以將注入至該第二埠中之血液之一溫度設定至一第一溫度位準。該第二熱交換器可經結構設計以將注入至該注入器構件中之血液之溫度設定至不同於該第一溫度位準之一第二溫度位準。該第一熱交換器可安置於該分支區段與該 第一埠之間或安置於該分支區段與該第二埠之間。 An exemplary system according to one of the principles herein can be used to provide at least two areas of selective thermal treatment. This exemplary system includes an extracorporeal loop. The exemplary extracorporeal loop includes an injector member that includes a distal tip disposed at a vascular location, and a proximal end disposed on the distal tip plus a minimal conductive component. The exemplary system may also include: a first port, which is used to draw blood from the body; a second port, which is used to return blood to the body; a first pump, which is placed in the first port and the second port Between the two ports to pump blood from the first port to the second port; a branch section positioned between the first pump and the second port; and a third port coupled to the branch Section, the third port is positioned on the outer side of a body of the injector member; and a second pump is positioned between the branch section and the third port. The second pump can be structurally designed to control a flow rate outside the branch section through the third port into the injector member. The exemplary system may also include a first heat exchanger disposed between the first port and the second port and a second heat exchanger disposed between the second pump and the injector member. The first heat exchanger can be structurally designed to set a temperature of the blood injected into the second port to a first temperature level. The second heat exchanger may be structurally designed to set the temperature of the blood injected into the injector member to a second temperature level different from the first temperature level. The first heat exchanger can be placed in the branch section and the Between the first port or between the branch section and the second port.
用於提供選擇性熱治療之至少兩個區域之例示性系統可包含安置於該注入器構件之遠端尖端之近端之一閉塞組件或一外加最小傳導組件。 An exemplary system for providing at least two areas of selective thermal treatment may include an occlusion component or an additional minimal conductive component disposed at the proximal end of the distal tip of the injector member.
根據本文中之原理之用於提供選擇性熱治療之至少兩個區域之另一例示性系統可包含一體外環路,該體外環路包含包括安置於一脈管位置處之一遠端尖端之一注入器構件。該例示性系統可進一步包含在該遠端尖端之近端之一控制分流系統。該控制分流系統可包含:一第一壓力感測器,其用於量測在至少一個注入器構件之一遠端尖端之近端之一第一壓力;及一第二壓力感測器,其用於量測一第二壓力,該第二壓力感測器安置成與該遠端尖端之近端相隔大於或近似等於脈管之一直徑之兩倍之一距離。在其他實例中,間距可大於或近似等於該脈管之直徑之三倍、五倍或十倍。在另一實例中,與該遠端尖端之近端相隔之間距大於約1.0cm。該例示性系統亦可包含:一第一埠,其用來從身體抽取血液;一第二埠,其用來將血液返回至身體;一第一泵,其安置於該第一埠與該第二埠之間以將血液從該第一埠泵送至該第二埠;一分支區段,其定位於該第一泵與該第二埠之間;一第三埠,其耦合至該分支區段,該第三埠定位於該注入器構件之一體外側上;及一第二泵,其定位於該分支區段與該第三埠之間。該第二泵可經結構設計以控制在該分支區段外透過該第三埠至該注入器構件中之一流率。該例示性系統亦可包含安置於該第一埠與該第二埠之間的一第一熱交換器及安置於該第二泵與該注入器構件之間的一第二熱交換器。該第一熱交換器可經結構設計以將注入至該第二埠中之血液之一溫度設定至一第一溫度位準。該第二熱交換器可經結構設計以將注入至該注入器構件中之血液之溫度設定至不同於該第一溫度位準之一第二溫度位準。該第一熱交換器可安置於該分支區段與該第一埠之間或安置於該分支 區段與該第二埠之間。 Another exemplary system for providing at least two regions of selective thermal treatment according to the principles herein may include an extracorporeal loop including a distal tip disposed at a vascular location An injector component. The exemplary system may further include a control shunt system at one of the proximal ends of the distal tip. The control shunt system may include: a first pressure sensor for measuring a first pressure at the proximal end of a distal tip of at least one injector member; and a second pressure sensor For measuring a second pressure, the second pressure sensor is arranged at a distance greater than or approximately equal to twice a diameter of a vessel from the proximal end of the distal tip. In other examples, the spacing may be greater than or approximately equal to three times, five times, or ten times the diameter of the vessel. In another example, the distance from the proximal end of the distal tip is greater than about 1.0 cm. The exemplary system may also include: a first port, which is used to draw blood from the body; a second port, which is used to return blood to the body; a first pump, which is placed in the first port and the second port Between the two ports to pump blood from the first port to the second port; a branch section positioned between the first pump and the second port; and a third port coupled to the branch Section, the third port is positioned on the outer side of a body of the injector member; and a second pump is positioned between the branch section and the third port. The second pump can be structurally designed to control a flow rate through the third port to the injector member outside the branch section. The exemplary system may also include a first heat exchanger disposed between the first port and the second port and a second heat exchanger disposed between the second pump and the injector member. The first heat exchanger can be structurally designed to set a temperature of the blood injected into the second port to a first temperature level. The second heat exchanger may be structurally designed to set the temperature of the blood injected into the injector member to a second temperature level different from the first temperature level. The first heat exchanger can be arranged between the branch section and the first port or in the branch Between the section and the second port.
用於提供選擇性熱治療之至少兩個區域之例示性系統可包含安置於該注入器構件之遠端尖端之近端之一閉塞組件或一外加最小傳導組件。 An exemplary system for providing at least two areas of selective thermal treatment may include an occlusion component or an additional minimal conductive component disposed at the proximal end of the distal tip of the injector member.
圖7A展示根據本文中之原理之用於提供選擇性熱治療之至少兩個區域之一例示性三埠體外環路之一示意圖。作為一非限制性實例,該體外環路可經實施以在獨立流率及溫度控制下控制至核心及附接局部分支之血流。在圖7A之非限制性實例中,體外系統700為一三埠、二區域的體外環路,其中一主靜脈-動脈(VA)體外迴路710經由一第一埠711從身體提取血液且使用一泵712及氧合器/熱交換器714以經由一第二埠715返回血液。該例示性系統可包含一排量或容積驅動泵716,該排量或容積驅動泵716定位於主迴路之一分支718上,且將一經控制容積流率之血液拉出主環路並透過一獨立熱交換器720、一第三埠721及遠端注入器構件722將血液注入至一身體之一區域724。在一非限制性實例中,分支718可為一局部灌注低溫分支。圖7A之非限制性例示性系統允許當部署有適當區域溫度感測器時在身體中建立兩個獨立控制溫度區域。在其它實例中,取決於使用者是否需要氧合注入器構件血液,分支718可耦合至主迴路氧合器714前方或後方之主迴路。在此等實例中,若該系統用來透過遠端注入器構件應用諸如國際(PCT)申請案第PCT/US2015/033529號中所揭示之局部低溫,則注入器構件上之一同心圓筒外流之缺乏可導致該構件導管至動脈(該構件導管放置於該動脈內)之傳導冷卻之一增大。此效應可需要主環路迴路上之一定額外增溫以在需要受控制之身體區域中實現等效熱目標。
Fig. 7A shows a schematic diagram of an exemplary three-port extracorporeal loop for providing selective thermal therapy in one of at least two areas according to the principles herein. As a non-limiting example, the extracorporeal loop can be implemented to control blood flow to the core and attach local branches under independent flow rate and temperature control. In the non-limiting example of FIG. 7A, the
圖7B展示根據本文中之原理之用於提供選擇性熱治療之至少兩個區域之另一例示性體外環路。類似於圖7A,圖7B之體外系統700'包含一主VA體外迴路710,該主VA體外迴路710經由一第一埠711從身體
提取血液且使用一泵712、一氧合器713及一熱交換器714經由一第二埠715返回血液。在一非限制性實例中,氧合器713及熱交換器714可為一組合單元。該例示性系統700'亦包含一排量或容積驅動泵716,該排量或容積驅動泵716定位於一分支718上,以將一經控制容積流率之血液拉出主環路並透過一獨立熱交換器720、一第三埠721及一遠端注入器構件722將血液注入至一身體之一局部區域。在體外系統700'之實例中,該注入器構件亦可包含:一閉塞構件;一外加最小傳導組件(根據本文中之實例之任何一者,包含圖3A至圖5C之任何一者);或一壓力感測器對,其耦合至該注入器構件(根據本文中之實例之任何一者,包含圖6A或圖6B);或一壓力感測器對及一閉塞構件或一外加最小傳導組件兩者。在圖7B之非限制性例示性系統中,注入器構件722包含一外加最小傳導組件726及一耦合壓力感測器對728兩者。在圖7B之實例中,主迴路上之氧合器714定位於區域注入器分支718前方且因此局部注入之血流被氧合。
Figure 7B shows another exemplary extracorporeal loop for providing at least two areas of selective thermal therapy according to the principles herein. Similar to FIG. 7A, the extracorporeal system 700' of FIG. 7B includes a main VA
圖7C展示根據本文中之原理之用於提供選擇性熱治療之至少兩個區域之另一例示性體外環路,其包含類似於結合圖7B所述之組件之組件。然而,在圖7C之體外系統700"中,主迴路上之氧合器713定位成沿局部注入器分支後方之迴路,且因此局部注入之血流未直接氧合。在一非限制性實例中,氧合器713及熱交換器714可為一組合單元。
Fig. 7C shows another exemplary extracorporeal loop for providing at least two regions for selective thermal treatment according to the principles herein, which includes components similar to those described in connection with Fig. 7B. However, in the
圖7A至圖7C之任何一者之非限制性例示性系統可包含耦合至身體之區以允許提供身體中之兩個獨立控制溫度區域處之溫度量測之溫度感測器。例如,至少一個溫度感測器可安置於由第二埠灌注之區處或依其他方式耦合至該區,且至少一個溫度感測器可安置於由遠端注入器構件灌注之身體之局部區域處或依其他方式耦合至該局部區域。安置於由第二埠灌注之區處或依其他方式耦合至該區之至少一個溫度 感測器可經結構設計以量測身體之一部分之一平均核心體溫及/或平均系統溫度。安置於由遠端注入器構件灌注之身體之局部區域處或依其他方式耦合至該局部區域之至少一個溫度感測器經結構設計以量測該局部區域之溫度。 The non-limiting exemplary system of any one of FIGS. 7A to 7C may include a temperature sensor coupled to a region of the body to allow providing temperature measurement at two independently controlled temperature regions in the body. For example, at least one temperature sensor can be placed at the area infused by the second port or otherwise coupled to the area, and at least one temperature sensor can be placed on a local area of the body injected by the distal injector member Or in other ways coupled to the local area. At least one temperature placed at the area filled by the second port or coupled to the area by other means The sensor can be designed to measure the average core body temperature and/or the average system temperature of a part of the body. At least one temperature sensor arranged at a local area of the body infused by the distal injector member or otherwise coupled to the local area is structurally designed to measure the temperature of the local area.
圖7A至圖7C之任何一者之非限制性例示性系統可包含耦合至熱交換器之至少一者之溫度感測器。 The non-limiting exemplary system of any one of FIGS. 7A-7C may include a temperature sensor coupled to at least one of the heat exchangers.
根據圖7A至圖7C之原理之其他非限制性例示性系統可經結構設計以對體外迴路中之血液執行其他程序,諸如但不限於透析、氧化、淨化、藥理操縱、光解或可用於血液之其他程序。可對主迴路或分支或兩者執行此等程序之任何一或多者(其中對迴路或分支執行不同量或數量之該等程序之一或多者)。 Other non-limiting exemplary systems based on the principles of FIGS. 7A to 7C can be structurally designed to perform other procedures on the blood in the extracorporeal circuit, such as but not limited to dialysis, oxidation, purification, pharmacological manipulation, photolysis, or can be used for blood Other procedures. Any one or more of these procedures can be performed on the main loop or branch or both (where a different amount or quantity of one or more of these procedures is performed on the loop or branch).
在圖7A至圖7C之非限制性例示性實例中,主迴路被描述為一VA迴路。然而,在其他例示性實施方案中,主迴路可為一靜脈-靜脈(VV)迴路而非一VA迴路。在一例示性VV迴路中,血液提取自脈管之靜脈側(通常從髂靜脈或下腔靜脈)且返回至腔靜脈中,通常高於或接近於心臟。在另一實例中,可在股靜脈中運用單個穿刺實施VV,且單個雙管腔導管可用來放置VV迴路血液輸出及各使用該導管之一管腔返回。 In the non-limiting illustrative examples of FIGS. 7A to 7C, the main loop is described as a VA loop. However, in other exemplary embodiments, the main circuit may be a vein-venous (VV) circuit instead of a VA circuit. In an exemplary VV circuit, blood is drawn from the venous side of the vessel (usually from the iliac vein or inferior vena cava) and returns to the vena cava, usually higher than or close to the heart. In another example, a single puncture can be used to implement VV in the femoral vein, and a single double-lumen catheter can be used to place the blood output of the VV circuit and each return using one lumen of the catheter.
根據本文中之原理之一例示性系統可包含一或多個控制台。例示性控制台可包含一或多個使用者介面,該一或多個使用者介面經結構設計以接收表示例示性體外系統主迴路及/或局部分支之泵、熱交換器及/或氧合器之一或多者之所要設定之輸入。例示性控制台可包含一或多個處理單元,該一或多個處理單元用來執行處理器可執行指令以導致泵、熱交換器及/或氧合器之一或多者在一定時間週期內變更至一不同操作設定及/或維持一特定操作設定。在任何實例中,可在該一或多個使用者介面處直接從一使用者或從另一計算器件接收該 輸入。例示性控制台可包含至少一個記憶體,該至少一個記憶體用來儲存可使用該一或多個處理單元實施之處理器可執行指令。例示性控制台可經結構設計以儲存及/或傳輸指示系統設定之資料及/或基於使用耦合至該控制台之例示性系統執行一或多個程序導出之任何量測資料。 According to one of the principles in this article, an exemplary system may include one or more consoles. The exemplary console may include one or more user interfaces that are structured to receive pumps, heat exchangers, and/or oxygenation representing the main circuit and/or local branches of the exemplary extracorporeal system The input to be set by one or more of the devices. An exemplary console may include one or more processing units that are used to execute processor-executable instructions to cause one or more of the pump, heat exchanger, and/or oxygenator to occur in a certain period of time Change to a different operation setting and/or maintain a specific operation setting. In any instance, the one or more user interfaces can be directly received from a user or from another computing device. enter. An exemplary console may include at least one memory for storing processor executable instructions that can be implemented using the one or more processing units. The exemplary console may be structured to store and/or transmit data indicating system settings and/or any measurement data derived based on the execution of one or more procedures using the exemplary system coupled to the console.
圖8A展示根據本文中之原理之耦合至一控制台802之一例示性體外環路系統800。類似於圖7B,圖8A之體外系統800包含一主VA體外迴路810,該主VA體外迴路810經由一第一埠811從身體提取血液且使用一泵812、一氧合器813及一熱交換器814經由一第二埠815返回血液。在一非限制性實例中,氧合器813及熱交換器814可為一組合單元。例示性系統800亦包含一排量或容積驅動泵816,該排量或容積驅動泵816定位於一分支818上,以將一經控制容積流率之血液拉出主環路並透過一獨立熱交換器820、一第三埠821及一遠端注入器構件822將血液注入至一身體之一局部區域。亦類似於圖7B之非限制性例示性系統,該注入器構件包含一外加最小傳導組件826及一壓力感測器對828。在圖8A之實例中,控制台802耦合至定位於一分支818上之排量或容積驅動泵816及壓力感測器對828。在其他實例中,控制台802可耦合至該系統之不同組件,包含該例示性系統之泵、熱交換器及/或氧合器之任何一或多者。
Figure 8A shows an exemplary
圖8A之非限制性例示性系統可包含耦合至身體之區以允許提供身體中之兩個獨立控制溫度區域處之溫度量測之溫度感測器。例如,至少一個溫度感測器可安置於由第二埠灌注之區處或依其他方式耦合至該局部區,且至少一個溫度感測器可安置於由遠端注入器構件灌注之身體之局部區處或依其他方式耦合至該局部區。安置於由第二埠灌注之區處或依其他方式耦合至該區之至少一個溫度感測器可經結構設計以量測身體之一部分之一平均核心體溫及/或平均系統溫度。安置 於由遠端注入器構件灌注之身體之局部區處或依其他方式耦合至該局部區之至少一個溫度感測器可經結構設計以量測該局部區之溫度。 The non-limiting exemplary system of FIG. 8A may include temperature sensors coupled to regions of the body to allow providing temperature measurement at two independently controlled temperature zones in the body. For example, at least one temperature sensor may be placed at the area injected by the second port or coupled to the local area in other ways, and at least one temperature sensor may be placed at the part of the body injected by the distal injector member The local area may be coupled to the local area in other ways. At least one temperature sensor arranged at the area perfused by the second port or coupled to the area in other ways can be structured to measure the average core body temperature and/or average system temperature of a part of the body. Placement At least one temperature sensor at a local area of the body infused by the distal injector member or otherwise coupled to the local area can be structurally designed to measure the temperature of the local area.
在一實例中,控制台802可結構設計為一操作控制台。在此實例中,該操作控制台可包含用來驅動熱交換器之一水冷卻器/加熱器及經結構設計以顯示用於實施一操作序列之操作步驟之使用者指令之一圖形使用者介面。控制台802之圖形使用者介面可經結構設計以實施該操作序列以導致體外環路控制由第二埠灌注之血液之溫度以調整由至少一個溫度感測器報告之一溫度量測以保持於一核心身體目標範圍內,且導致體外環路控制注入至局部區之血液之溫度,使得至少一個溫度感測器報告一目標區溫度範圍內之一溫度量測。
In an example, the
例示性控制台802可經結構設計以使用本文中所述之控制分流系統之方法自動化Gb及Gtip量測之效能。基於經接收之輸入,該控制台可導致一處理器執行用於記錄指示注入器構件內之流及注入器構件上之壓力之值之資料之指令,同時亦控制經注入之流率之量,以根據本文中所述之實例之任何一者之原理協助或實現該注入器構件處之近端傳導及遠端傳導之量測之方法之自動效能。此一例示性控制台802可經結構設計以自動化該控制分流系統,其中該控制分流系統應用於耦合至一全體外迴路或具有一體外容積流率源(諸如但不限於圖6A中之實例)之另一導管系統之注入器構件。
The
圖8B展示根據本文中之原理之耦合至一控制台852之另一例示性系統850。例示性系統850包含一流率控制源860及儲液器862。作為一非限制性實例,例示性流率控制源860及儲液器862可為但不限於一注射器或注射器驅動器。例示性系統850亦包含耦合至一身體之一局部區之一遠端注入器構件872。注入器構件872包含一外加最小傳導組件876及一壓力感測器對878。在圖8B之實例中,控制台802耦合至流率控制源860及壓力感測器對878。在圖8B之實例中,流率控制源860及
儲液器862用來建立控制分流系統之兩個Ftip設定(根據上文中所述之實例之任何一者)。作為一非限制性實例,基於在該控制台處接收之指令之設定可首先依例如50ml/min將血液抽取至該儲液器達2分鐘,接著等待兩分鐘,接著依50ml/min返回血液達兩分鐘。在此非限制性實例中,此建立Ftip=-50ml/min、Ftip=0及Ftip=+50ml/min。基於在控制台852處例如從一使用者或其他計算器件接收之輸入,指令可經執行以根據該輸入中指定之設定執行任何其他所要程序。
Figure 8B shows another
根據本文中之原理之一例示性系統可包含用於控制一流體流之一或多個控制器。例如,該一或多個控制器可耦合至一注入構件以控制該注入器構件之遠端尖端外之流體流。 An exemplary system according to one of the principles herein may include one or more controllers for controlling a fluid flow. For example, the one or more controllers may be coupled to an injection member to control fluid flow outside the distal tip of the injector member.
根據本文中之原理之一例示性系統可包含一控制台。圖9展示一例示性控制台905,其包含至少一個處理單元907及一記憶體909。一例示性控制台可包含例如一桌上型電腦、一膝上型電腦、一平板電腦、一智慧型電話、一伺服器、一計算雲端、其組合、或根據本文中之原理之能夠與一控制器或其他系統進行電子通信之任何其他合適器件。例示性處理單元907可包含但不限於一微晶片、一處理器、一微處理器、一專用處理器、一特定應用積體電路、一微控制器、一場可程式化閘陣列、任何其他合適處理器、或其組合。例示性記憶體909可包含但不限於硬體記憶體、非暫時性有形媒體、儲存磁碟、光碟、快閃驅動裝置、計算器件記憶體、隨機存取記憶體(諸如但不限於DRAM、SRAM、EDO RAM)、任何其他類型之記憶體、或其組合。
According to one of the principles in this article, an exemplary system may include a console. FIG. 9 shows an
在一實例中,該控制台可包含一顯示單元911。例示性顯示單元111可包含但不限於一LED監控器、一LCD監控器、一電視機、一CRT監控器、一觸控螢幕、一電腦監控器、一觸控螢幕監控器、一行動器件(諸如但不限於一智慧型電話、一平板電腦或一電子書)之一螢幕或顯示器、及/或任何其他顯示單元。
In an example, the console may include a
圖10A至圖10B展示根據本文中之原理之可使用一例示性分流系統或包含耦合至一導管構件之至少兩個壓力感測器之一例示性系統實施之例示性方法。可使用一控制器,基於來自執行儲存至一記憶體之指令之一處理單元之一命令或其他信號實施圖10A至圖10B之步驟之一或多者。 Figures 10A to 10B show exemplary methods that can be implemented using an exemplary shunt system or an exemplary system including at least two pressure sensors coupled to a conduit member according to the principles herein. A controller may be used to implement one or more of the steps in FIGS. 10A to 10B based on a command or other signal from a processing unit that executes instructions stored in a memory.
圖10A展示包含以下步驟之一例示性方法:(步驟1002)在一時間間隔T內將於注入器構件之遠端尖端處注入之流體流控制至一預定流率模式;(步驟1004)在該時間間隔T內記錄使用第一壓力感測器及第二壓力感測器之壓力量測;及(步驟1006)使用指示該等壓力量測及該預定流率模式之資料計算該遠端尖端處之一近端外部傳導或一遠端外部傳導之至少一者。該遠端尖端可為一體外環路之一注入器構件或一導管構件之一部分。在一實例中,可使用一注入流率源控制該流率模式。在一實例中,該注入流率源可為一泵。 Figure 10A shows an exemplary method comprising the following steps: (step 1002) the fluid flow injected at the distal tip of the injector member is controlled to a predetermined flow rate mode within a time interval T; (step 1004) in the Record the pressure measurements using the first pressure sensor and the second pressure sensor in the time interval T; and (step 1006) use the data indicating the pressure measurements and the predetermined flow rate mode to calculate the position at the distal tip At least one of a proximal external conduction or a distal external conduction. The distal tip can be an injector member of an extracorporeal loop or a part of a catheter member. In one example, an injection flow rate source can be used to control the flow rate mode. In one example, the injection flow rate source may be a pump.
圖10B展示根據本文中之原理之可使用一例示性分流系統或包含耦合至一導管構件之至少兩個壓力感測器之一例示性系統實施之另一例示性方法。在步驟1052中,在一第一時間間隔(TA)內將於一注入器構件(或一導管構件)之遠端尖端處注入之血流控制至一第一恆定流率。在步驟1054中,在該第一時間間隔(TA)期間記錄使用第一壓力感測器及第二壓力感測器之各者之至少一第一壓力量測(P1A及P1B)。在步驟1056中,在一第二時間間隔(TB)內將於該注入器構件之遠端尖端處注入之血流控制至不同於該第一恆定流率之一第二恆定流率。在步驟1058中,在該第二時間間隔(TB)期間記錄使用第一壓力感測器及第二壓力感測器之各者之至少一第二壓力量測(P2A及P2B)。在步驟1060中,使用該處理單元之至少一個處理器以使用指示該第一壓力量測、該第二壓力量測、該第一恆定流率及該第二恆定流率之資料計算該注入器構件(或導管構件)之遠端尖端處之一近端外部傳導或一遠端外部
傳導之至少一者。
Figure 10B shows another exemplary method that can be implemented using an exemplary shunt system or an exemplary system including at least two pressure sensors coupled to a conduit member in accordance with the principles herein. The distal tip of the injection, the blood flow in
在一實例中,該例示性控制台可導致該顯示單元基於計算顯示該近端外部傳導或該遠端外部傳導或兩者之一指示。 In one example, the exemplary console may cause the display unit to display an indication of the proximal external conduction or the distal external conduction or one of the two based on calculations.
在一實例中,亦可導致該處理單元在遲於第一時間間隔(TA)及第二時間間隔(TB)之一第三時間間隔(TC)內計算一近端外部傳導或一遠端外部傳導之至少一者之一投影。 In an example, the processing unit may also be caused to calculate a proximal external conduction or a third time interval (T C ) later than one of the first time interval (T A ) and the second time interval (T B ) At least one of the distal external conduction is projected.
圖11為根據本文中之原理之可用來實施一操作之一例示性計算器件1110之一方塊圖。在本文中之任何實例中,計算器件1110可結構設計為一控制台。為了清楚起見,圖11亦被重新提及且提供關於圖9之例示性系統之各種元件之更詳細細節。計算器件1110可包含用於儲存一或多個電腦可執行指令或軟體以實施實例之一或多個非暫時性電腦可讀媒體。該非暫時性電腦可讀媒體可包含但不限於以下一或多種類型之硬體記憶體、非暫時性有形媒體(例如,一或多個儲存磁碟、一或多個光碟、一或多個快閃驅動裝置)等。例如,計算器件1110中包含之記憶體909可儲存用於執行本文中所揭示之操作之電腦可讀及電腦可執行指令或軟體。例如,記憶體909可儲存經結構設計以執行各種所揭示操作(例如,導致一控制器控制流,記錄一壓力感測器量測或執行一計算)之一軟體應用程式1140。計算器件1110亦可包含可結構設計及/或可程式化處理器907及一相關聯核心1114,及視需要用於執行儲存於記憶體909中之電腦可讀及電腦可執行指令或軟體以及用於控制系統硬體之其他程式之一或多個額外可結構設計及/或可程式化處理器件,例如,處理器1112'及相關聯核心1114'(例如,在具有多個處理器/核心之計算器件之情況下)。處理器907及處理器1112'可各為單核心處理器或多核心(1114及1114')處理器。
FIG. 11 is a block diagram of an
虛擬化可用於計算器件1110中使得可動態地共用控制台中之基礎結構及資源。一虛擬機1124可經提供以處置在多個處理器上運行之一
程序使得該程序表現為僅使用一個計算資源而非多個計算資源。亦可結合一個處理器使用多個虛擬機。
Virtualization can be used in the
記憶體909可包含一計算器件記憶體或隨機存取記憶體,諸如DRAM、SRAM、EDO RAM等。記憶體909亦可包含其他類型之記憶體或其組合。
The
一使用者可透過一視覺顯示單元1128(諸如可顯示可根據例示性系統及方法提供之一或多個使用者介面1130之一電腦監控器)與計算器件1110進行互動。計算器件1110可包含用於從一使用者接收輸入之其他I/O器件,例如,一鍵盤或任何合適多點觸控介面1118、一指向器件1120(例如,一滑鼠)。鍵盤1118及指向器件1120可耦合至視覺顯示單元1128。計算器件1110可包含其他合適的習知I/O周邊裝置。
A user can interact with the
計算器件1110亦可包含一或多個儲存器件1134,諸如一硬碟機、CD-ROM或用於儲存執行本文中所揭示之操作之資料及電腦可讀指令及/或軟體之其他電腦可讀媒體。例示性儲存器件1134亦可儲存用於儲存實施例示性系統及方法所要之任何合適資訊之一或多個資料庫。資料庫可在任何合適時間手動或自動更新以添加、刪除及/或更新資料庫中之一或多個項目。
The
計算器件1110可包含一網路介面1122,其經結構設計以經由一或多個網路器件1132透過各種連接(包含但不限於標準電話線、區域網路(LAN)或廣域網路(WAN)鏈路(例如,802.11、T1、T3、56kb、X.25)、寬頻連接(例如,ISDN、訊框中繼器、ATM)、無線連接、控制器區域網路(CAN)或上述連接之任何一者或所有之某個組合)與一或多個網路(例如,LAN、WAN或網際網路)介接。網路介面1122可包含一內建網路適配器、網路介面卡、PCMCIA網路卡、卡匯流排網路適配器、無線網路適配器、USB網路適配器、數據機或適於將計算器件1110介接至能夠進行通信且執行本文中所述之操作之任何類型之網路
之任何其他器件。此外,計算器件1110可為任何計算器件,諸如一工作站、桌上型電腦、伺服器、膝上型電腦、手持型電腦、平板電腦、或能夠進行通信且具有用來執行本文中所述之操作之足夠處理器功率及記憶容量之其他形式之計算或電信器件。
The
計算器件1110可運行任何作業系統1126,諸如Microsoft® Windows®作業系統之版本之任何一種、Unix及Linux作業系統之不同版本、Macintosh電腦之MacOS®之任何版本、任何嵌入式作業系統、任何即時作業系統、任何開放源作業系統、任何專屬作業系統、或能夠在控制台上運行且執行本文中所述之操作之任何其他作業系統。在一些實例中,操作系統1126可依本機模式或模擬模式運行。在一實例中,操作系統1126可在一或多個雲端機例項上運行。
The
在非限制性實例中,根據本文中之原理之計算器件可包含以下項之任何一或多者:一智慧型電話(諸如但不限於一iPhone®、一AndroidTM電話或一Blackberry®)、一平板電腦、一膝上型電腦、一平板觸控電腦、一電子遊戲系統(諸如但不限於一XBOX®、一Playstation®或一Wii®)、一電子閱讀器(e-reader)及/或其他電子閱讀器或手持型計算器件。 In a non-limiting example, a computing device according to the principles herein may include any one or more of the following: a smart phone (such as but not limited to an iPhone®, an Android TM phone or a Blackberry®), a Tablet computer, a laptop computer, a tablet touch computer, an electronic game system (such as but not limited to an XBOX®, a Playstation® or a Wii®), an e-reader and/or other E-reader or handheld computing device.
在本文中之任何實例中,可使用一電腦程式實施本文中之至少一種方法。該電腦程式(亦稱為程式、軟體、軟體應用程式、腳本、應用程式或程式碼)可依任何形式之程式語言(包含編譯或解譯語言、宣告或程序語言)寫入,且其可依任何形式(包含如一獨立程式或一模組、組件、子常式、對象或適於在一計算環境中使用之其他單元)部署。一電腦程式可但無需對應於一檔案系統中之一檔案。一程式可依專用於討論中之程式之單個檔案或多個協調檔案(例如,儲存一或多個模組、子程式或程式碼部分之檔案)儲存於保存其他程式或資料(例如,儲存於一標記語言文件中之一或多個腳本)之一檔案之一部分 中。一電腦程式可經部署以在定位於一個位點處之一個電腦上或在跨多個位點分佈且藉由一通信網路互連之多個電腦上執行。 In any example herein, a computer program can be used to implement at least one of the methods herein. The computer program (also called program, software, software application, script, application or program code) can be written in any form of programming language (including compilation or interpretation language, declaration or programming language), and it can be written in accordance with Any form (including, for example, an independent program or a module, component, subroutine, object, or other unit suitable for use in a computing environment) deployment. A computer program can but does not need to correspond to a file in a file system. A program can be stored in a single file or multiple coordinated files (for example, files that store one or more modules, subprograms, or code parts) dedicated to the program under discussion in order to save other programs or data (for example, in One or more scripts in a markup language document) a part of an archive in. A computer program can be deployed to be executed on one computer located at one site or on multiple computers distributed across multiple sites and interconnected by a communication network.
一例示性計算器件可包含用來執行諸如以下步驟之功能之一應用(「App」):分析溫度感測器資料、壓力感測器資料及計算傳導,如本文中所述。作為一非限制性實例,該App可經結構設計以下載為一AndroidTM相容系統之一*.apk檔案或一iOS®相容系統之一*.app檔案。 An exemplary computing device may include an application ("App") for performing one of functions such as the following steps: analyzing temperature sensor data, pressure sensor data, and calculating conduction, as described herein. As a non-limiting example, the App can be structured to download as an Android TM compatible system * .apk file or an iOS® compatible system * .app file.
根據本文中之原理之一例示性控制台可對於諸如國際(PCT)申請案第PCT/US2015/033529號中所述之一操作序列實施一控制程序,該案以引用方式併入本文中。例如,該控制台可包含包含一使用者介面之一顯示器及用來驅動熱交換器之冷卻器/加熱器。該例示性控制台可耦合至:至少一個第一溫度感測器,其經定位以量測使用第二埠灌注之身體之一部分之一平均核心體溫及/或平均系統溫度;及至少一個第二溫度感測器,其經定位以量測由注入器構件灌注之一局部區之溫度。該使用者介面經結構設計以顯示用於實施一操作序列之操作步驟之使用者指令。一非限制性例示性控制台可包含如本文中所定義之一使用者介面及計算器件,該使用者介面及計算器件用來實施一半自動控制程序使得在一操作之所有階段中,可在裝置中設定溫度帶且若在各階段期間感測器溫度偏離目標範圍,則可通知操作者調整冷卻器溫度。一非限制性例示性控制台可包含如本文中所定義之一使用者介面及計算器件,該使用者介面及計算器件用來實施一全自動控制程序使得在一操作之所有階段中,可在裝置中設定溫度帶且系統可經結構設計以在感測器溫度在各階段期間偏離目標範圍之情況下,自動調整冷卻器溫度。 According to one of the principles herein, an exemplary console can implement a control program for an operation sequence such as that described in International (PCT) Application No. PCT/US2015/033529, which is incorporated herein by reference. For example, the console may include a display including a user interface and a cooler/heater for driving the heat exchanger. The exemplary console may be coupled to: at least one first temperature sensor positioned to measure the average core body temperature and/or average system temperature of a part of the body that is perfused using the second port; and at least one second The temperature sensor is positioned to measure the temperature of a local area injected by the injector member. The user interface is structured to display user commands for implementing the operation steps of an operation sequence. A non-limiting exemplary console may include a user interface and computing device as defined herein, the user interface and computing device are used to implement a semi-automatic control program so that in all stages of an operation, the device can be If the sensor temperature deviates from the target range during each stage, the operator can be notified to adjust the cooler temperature. A non-limiting exemplary console may include a user interface and computing device as defined herein, the user interface and computing device are used to implement a fully automatic control program so that in all stages of an operation, The temperature zone is set in the device and the system can be structured to automatically adjust the cooler temperature when the sensor temperature deviates from the target range during each stage.
本文中之任何例示性系統及方法可用來對於遭受一局部或全域損傷性缺血或循環性損害之一患者,針對一治療程序之至少部分建立 及控制一身體之至少部分之兩個不同溫度區域,諸如國際(PCT)申請案第PCT/US2015/033529號中所述。一例示性方法可包含使用一周邊放置迴路將一全身灌注體外環路(SPEC)耦合至身體及將一局部灌注體外環路(LPEC)耦合至在脈管內流動至身體之一局部目標區(諸如但不限於大腦)之血液。該SPEC可包含與在脈管內流動之血液接觸之一SPEC輸入流埠及一SPEC輸出流埠、一SPEC泵及一SPEC熱交換器。該LPEC可包含與在脈管內流動之血液接觸之一LPEC輸入流埠及一LPEC輸出流埠、一LPEC泵及一LPEC熱交換器。該LPEC輸入流埠經安置以灌注身體之局部目標區。該方法包含:定位至少一個SPEC感測器以量測由該SPEC灌注之身體之平均核心體溫及/或平均系統溫度;定位至少一個LPEC感測器以量測由該LPEC灌注之局部目標區之溫度;執行至少一最小操作序列之操作步驟;及實施一控制程序以記錄該至少一個LPEC感測器及該至少一個SPEC感測器之量測且分別獨立地控制該SPEC及該LPEC之一血流率及一熱交換器溫度。該LPEC可包含一注入器構件,該注入器構件包含安置成與在脈管內流動之血液接觸之一遠端尖端,其中該LPEC注入器構件經安置以灌注身體之局部目標區。該LPEC可包含根據本文中所述之原理之一外加最小傳導組件或一控制分流系統或兩者。在其中該LPEC包含一控制分流系統之一實例中,LPEC泵可用作該控制分流系統之一注入流率源。 Any of the exemplary systems and methods described herein can be used to establish at least part of a treatment program for a patient suffering from a partial or global injury, ischemia or circulatory injury. And control two different temperature zones of at least part of a body, such as described in International (PCT) Application No. PCT/US2015/033529. An exemplary method may include coupling a whole body perfusion extracorporeal circuit (SPEC) to the body using a peripheral placement circuit and coupling a local perfusion extracorporeal circuit (LPEC) to flow in a vessel to a local target area of the body ( Such as but not limited to the blood of the brain. The SPEC may include a SPEC input port and a SPEC output port in contact with blood flowing in a vessel, a SPEC pump, and a SPEC heat exchanger. The LPEC may include an LPEC input port and an LPEC output port in contact with blood flowing in a vessel, an LPEC pump, and an LPEC heat exchanger. The LPEC input port is arranged to perfuse local target areas of the body. The method includes: positioning at least one SPEC sensor to measure the average core body temperature and/or average system temperature of the body perfused by the SPEC; positioning at least one LPEC sensor to measure the local target area perfused by the LPEC Temperature; execute the operation steps of at least one minimum operation sequence; and implement a control program to record the measurement of the at least one LPEC sensor and the at least one SPEC sensor and independently control one of the SPEC and the LPEC respectively Flow rate and a heat exchanger temperature. The LPEC may include an injector member that includes a distal tip disposed in contact with blood flowing in a vessel, wherein the LPEC injector member is disposed to infuse a local target area of the body. The LPEC may include one of the principles described herein plus a minimum conductive component or a control shunt system or both. In an example in which the LPEC includes a controlled flow distribution system, the LPEC pump can be used as an injection flow rate source of the controlled flow distribution system.
該LPEC輸入流埠可安置成與左頸總動脈、右頸總動脈或該等位置之一者下游之一動脈接觸。 The LPEC inlet port can be placed in contact with the left common carotid artery, the right common carotid artery, or an artery downstream of one of these locations.
在一實例中,該控制程序可導致該SPEC控制由該SPEC注入之血流之溫度以調整由SPEC溫度感測器報告之溫度量測以保持於一目標核心體溫範圍內,且導致該LPEC控制注入至該目標區之血液之溫度使得一或多個LPEC溫度感測器根據目標區溫度值之一指定模式報告一溫度量測。SPEC溫度感測器可為一膀胱溫度感測器或一直腸溫度 感測器之一或多者。 In one example, the control program may cause the SPEC to control the temperature of the blood stream injected by the SPEC to adjust the temperature measurement reported by the SPEC temperature sensor to stay within a target core body temperature range, and cause the LPEC to control The temperature of the blood injected into the target zone causes one or more LPEC temperature sensors to report a temperature measurement according to a specified mode of the target zone temperature value. The SPEC temperature sensor can be a bladder temperature sensor or a constant bowel temperature One or more of the sensors.
在另一實例中,該控制程序可導致該SPEC調整身體之全身溫度使得一或多個SPEC溫度感測器指示在從約32℃至約37℃以下之範圍內之一平均溫度,且導致該LPEC控制至該目標區之血液之溫度使得一或多個LPEC溫度感測器指示低於約30℃之一溫度。該控制程序可導致該SPEC增大血液溫度以防止平均溫度降低至約32℃以下。該控制程序可導致該LPEC將血液溫度冷卻至在約10℃至約30℃之範圍內之一值。 In another example, the control program may cause the SPEC to adjust the body's whole body temperature such that one or more SPEC temperature sensors indicate an average temperature in the range from about 32°C to about 37°C or less, and cause the The LPEC controls the temperature of the blood to the target zone so that one or more LPEC temperature sensors indicate a temperature below about 30°C. The control program can cause the SPEC to increase the blood temperature to prevent the average temperature from falling below about 32°C. The control program can cause the LPEC to cool the blood temperature to a value in the range of about 10°C to about 30°C.
本文中之任何例示性系統可包含經程式化以執行該控制程序之一控制系統。例如,該控制系統可經程式化以獨立於SPEC泵處之一流率設定LPEC泵及LPEC熱交換器處之一流率及一溫度。該控制系統可經程式化以導致該LPEC自動地或基於一手動輸入控制至該目標區之血流之溫度。該控制系統可經程式化以導致該SPEC增大血液溫度以防止平均溫度降低至約32℃以下。該控制系統可經程式化以導致該LPEC將血液溫度冷卻至在約10℃至約30℃之範圍內之一值。 Any exemplary system herein can include a control system programmed to execute the control program. For example, the control system can be programmed to set a flow rate and a temperature at the LPEC pump and the LPEC heat exchanger independently of a flow rate at the SPEC pump. The control system can be programmed to cause the LPEC to control the temperature of the blood flow to the target zone automatically or based on a manual input. The control system can be programmed to cause the SPEC to increase the blood temperature to prevent the average temperature from dropping below about 32°C. The control system can be programmed to cause the LPEC to cool the blood temperature to a value in the range of about 10°C to about 30°C.
結論in conclusion
雖然本文中已描述及闡釋各項發明實施例,但一般技術者將容易設想用於執行本文中所述之功能及/或獲得本文中所述之結果及/或本文中所述之優點之一或多者之各種其他構件及/或結構,且此等變動及/或修改之各者應被視為在本文中所述之本發明實施例之範疇內。更一般言之,一般技術者將容易明白,本文中所述之所有參數、尺寸、材料及結構設計意謂著例示性且實際參數、尺寸、材料及/或結構設計將取決於使用本發明教示之特定應用。熟習此項技術者將認知或能夠僅使用常規實驗確證本文中所述之特定發明實施例之諸多等效物。因此,應瞭解,前述實施例僅藉由實例而提出且在隨附申請專利範圍及其等效物之範疇內,本發明實施例可依除具體所述及所主張 之方式外之方式實行。本發明之發明實施例可關於本文中所述之各個別特徵、系統、物件、材料、套組及/或方法。此外,若此等特徵、系統、物品、材料、套組及/或方法不相互排斥,則兩個或更多個此等特徵、系統、物品、材料、套組及/或方法之任何組合包含於本發明之發明範疇內。 Although various embodiments of the invention have been described and illustrated herein, those of ordinary skill will easily conceive of being used to perform the functions described herein and/or obtain the results described herein and/or one of the advantages described herein Various other components and/or structures of one or more, and each of these changes and/or modifications should be regarded as being within the scope of the embodiments of the present invention described herein. More generally, those skilled in the art will easily understand that all the parameters, dimensions, materials, and structural design described herein are meant to be exemplary and the actual parameters, dimensions, materials, and/or structural design will depend on the use of the teachings of the present invention. The specific application. Those skilled in the art will recognize or be able to use only routine experiments to confirm many equivalents of the specific invention embodiments described herein. Therefore, it should be understood that the foregoing embodiments are only presented by way of examples and are within the scope of the appended patent application and their equivalents. The embodiments of the present invention may be subject to specific descriptions and claims. It is implemented in a way other than the way. The inventive embodiments of the present invention may be related to the individual features, systems, objects, materials, kits, and/or methods described herein. In addition, if these features, systems, articles, materials, kits, and/or methods are not mutually exclusive, any combination of two or more of these features, systems, articles, materials, kits, and/or methods includes Within the scope of the invention.
本發明之上述實施例可依眾多方式之任何一種實施。例如,一些實施例可使用硬體、軟體或其之一組合實施。在一實施例之任何態樣至少部分依軟體實施時,可在任何合適處理器或處理器集合上執行軟體碼,無論其是提供於單個電腦中還是分佈於多個電腦當中。 The above-mentioned embodiments of the present invention can be implemented in any of numerous ways. For example, some embodiments may be implemented using hardware, software, or a combination thereof. When any aspect of an embodiment is implemented at least in part by software, the software code can be executed on any suitable processor or collection of processors, whether it is provided in a single computer or distributed among multiple computers.
就此而言,本發明之各個態樣可至少部分體現為編碼有一或多個程式之一電腦可讀儲存媒體(或多電腦可讀儲存媒體)(例如,一電腦記憶體、一或多個軟碟、光碟、光學碟、磁帶、快閃記憶體、場可程式化閘陣列或其他半導體器件中之環路結構設計、或其他有形電腦儲存媒體或非暫時性媒體),該一或多個程式在於一或多個電腦或其他處理器上被執行時執行實施上文所論述之技術之各項實施例之方法。該(等)電腦可讀媒體可為便攜式,使得其上儲存之程式可載入至一或多個不同電腦或其他處理器上以實施如上文所論述之本發明技術之各個態樣。 In this regard, the various aspects of the present invention can be at least partially embodied as a computer-readable storage medium (or multiple computer-readable storage media) encoding one or more programs (for example, a computer memory, one or more software Disk, compact disc, optical disc, magnetic tape, flash memory, field programmable gate array or loop structure design in other semiconductor devices, or other tangible computer storage media or non-transitory media), the one or more programs When executed on one or more computers or other processors, the methods of implementing the various embodiments of the techniques discussed above are executed. The computer-readable medium(s) can be portable, so that the programs stored thereon can be loaded onto one or more different computers or other processors to implement various aspects of the technology of the present invention as discussed above.
在一般意義上,術語「程式」或「軟體」在本文中用來指代可用來程式化一電腦或其他處理器以實施如上文所論述之本發明技術之各個態樣之任何類型之電腦程式碼或電腦可執行指令集。此外,應明白,根據此實施例之一個態樣,在被執行時執行本發明技術之方法之一或多個電腦程式無需駐留於單個電腦或處理器上,但可依一模組化方式分佈於數個不同電腦或處理器當中以實施本發明技術之各個態樣。 In a general sense, the term "program" or "software" is used herein to refer to any type of computer program that can be used to program a computer or other processor to implement various aspects of the technology of the invention as discussed above Code or computer executable instruction set. In addition, it should be understood that according to one aspect of this embodiment, one or more computer programs that perform the method of the present invention when executed need not reside on a single computer or processor, but can be distributed in a modular manner Various aspects of the technology of the present invention are implemented in several different computers or processors.
電腦可執行指令可呈諸多形式,諸如由一或多個電腦或其他器 件執行之程式模組。通常,程式模組包含執行特定任務或實施特定抽象資料類型之常式、程式、對象、組件、資料結構等。通常,可在各項實施例中按需組合或分佈程式模組之功能。 Computer-executable instructions can take many forms, such as by one or more computers or other devices. The program module of the software execution. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. Generally, the functions of the program modules can be combined or distributed as needed in various embodiments.
再者,本文中所述之技術可體現為已提供其之至少一項實例之一方法。執行為該方法之部分之動作可依任何合適方式排序。據此,可建構其中依不同於所闡釋之次序之一次序執行(可包含同時執行一些動作,即使在闡釋性實施例中被展示為循序動作)之實施例。 Furthermore, the technology described herein can be embodied as a method of providing at least one example thereof. The actions performed as part of the method can be sequenced in any suitable way. Accordingly, an embodiment can be constructed in which execution is performed in an order different from the order illustrated (which may include performing some actions at the same time, even if shown as sequential actions in the illustrated embodiment).
如本文中所定義及使用之所有定義應被理解為對詞典定義、以引用方式併入之文件之定義及/或所定義術語之普通意義之控制。 All definitions as defined and used herein should be understood as control over dictionary definitions, definitions of documents incorporated by reference, and/or ordinary meanings of defined terms.
除非明確指示為相反,否則如本文在說明書及申請專利範圍中所使用之不定冠詞「一」及「一個」應被理解為意謂著「至少一個」。 Unless expressly indicated to the contrary, the indefinite articles "a" and "an" used in the specification and the scope of the patent application shall be understood as meaning "at least one".
如本文在說明書及申請專利範圍中所使用之片語「及/或」應被理解為意謂著如此接合之元件之「任一者或兩者」,即,在一些情況下共同存在且在其他情況下分開存在之元件。應依相同方式解釋運用「及/或」列舉之多個元件,即,如此結合之元件之「一或多者」。視需要,可存在除藉由「及/或」從句具體識別之元件外之其他元件,無論其他元件是否與該等具體識別的元件相關。因此,作為一非限制性實例,在結合開放式語言(諸如「包括」)使用時,對「A及/或B」之一參考可在一項實施例中指代僅A(視需要包含除B外之元件);在另一實施例中指代僅B(視需要包含除A外之元件);在又一實施例中指代A及B兩者(視需要包含其他元件)等。 As used herein in the specification and the scope of the patent application, the phrase "and/or" should be understood as meaning "either or both" of the elements so joined, that is, co-exist and in some cases In other cases, separate existing components. The multiple elements listed using "and/or" should be interpreted in the same way, that is, "one or more" of the elements so combined. If necessary, there may be other elements besides the elements specifically identified by the "and/or" clause, regardless of whether the other elements are related to the specifically identified elements. Therefore, as a non-limiting example, when used in conjunction with an open language (such as "including"), a reference to one of "A and/or B" may refer to only A (including other than B if necessary) in one embodiment. In another embodiment, it refers to only B (including components other than A as required); in another embodiment, it refers to both A and B (including other components as required).
如本文在說明書及申請專利範圍中所使用,「或」應被理解為具有相同於如上文所定義之「及/或」之意義。例如,在使一清單中之項目分離時,「或」或「及/或」應被解釋為包含性,即,包含數個元件或元件清單中之至少一者,但亦包含一個以上,且視需要包含額外 未列項目。僅明確指示為相反之術語(諸如「...之僅一者」)或「...之唯一一者」或在用於申請專利範圍中時「由...組成」將指代包含數個元件或元件清單中之唯一一個元件。一般言之,如本文中所使用之術語「或」應僅被解釋為指示排他性術語(諸如「任一者」、「...之一者」、「...之僅一者」、「...之恰一者」)之前的排他性替代詞(即,「一者或另一者但非兩者」)。「基本上由...組成」在用於申請專利範圍中時應具有其如在專利法領域中所使用之普通意義。 As used herein in the specification and the scope of patent application, "or" should be understood as having the same meaning as "and/or" as defined above. For example, when separating items in a list, "or" or "and/or" should be interpreted as inclusive, that is, it includes at least one of several elements or element lists, but also includes more than one, and Include additional as needed Unlisted items. Terms that only expressly indicate to the contrary (such as "the only one of...") or "the only one of..." or "consisting of" when used in the scope of the patent application will refer to the inclusion Several components or the only component in the component list. Generally speaking, the term "or" as used in this article should only be interpreted as indicating exclusive terms (such as "any one", "one of...", "only one of...", " ...The exact one") exclusive alternative (ie, "one or the other but not both"). "Basically consisting of" when used in the scope of patent application should have its ordinary meaning as used in the field of patent law.
如本文在說明書及申請專利範圍中所使用,在對一或多個元件之一清單之參考中,片語「至少一個」應被理解為意謂著選自該元件清單中之元件之任何一或多者之至少一個元件,但不一定包含該元件清單內具體所列之各個元件之至少一者且不排除該元件清單中之元件之任何組合。此定義亦允許可視需要存在除片語「至少一個」所指代之元件之清單內具體識別之元件外之元件,無論該等元件是否與該等具體識別元件相關。因此,作為一非限制性實例,「A及B之至少一者」(或等效地「A或B之至少一者」,或等效地「A及/或B之至少一者」)可在一項實施例中指代視需要包含一個以上A且不包含B之至少一者(且視需要包含除B外之元件);在另一實施例中指代視需要包含一個以上B且不存在A之至少一者(且視需要包含除A外之元件);在又一實施例中指代視需要包含一個以上A之至少一者及視需要包含一個以上B之至少一者(且視需要包含其他元件)等。 As used herein in the specification and the scope of patent applications, in reference to a list of one or more elements, the phrase "at least one" should be understood to mean any one of the elements selected from the list of elements Or at least one element of more than one, but does not necessarily include at least one of each element specifically listed in the element list and does not exclude any combination of the elements in the element list. This definition also allows components other than specifically identified components in the list of components referred to by the phrase "at least one" to exist as needed, regardless of whether the components are related to the specifically identified components. Therefore, as a non-limiting example, "at least one of A and B" (or equivalently "at least one of A or B", or equivalently "at least one of A and/or B") may In one embodiment, it refers to optionally including more than one A and not including at least one of B (and optionally including elements other than B); in another embodiment, it refers to optionally including more than one B and not including A At least one of (and optionally includes components other than A); in another embodiment, it refers to at least one of more than one A and at least one of more than one B (and optionally other Components) and so on.
在申請專利範圍以及上述說明書中,所有過渡片語(諸如「包括」、「包含」、「攜帶」、「具有」、「含有」、「涉及」、「保持」、「由...組成」等)應被理解為開放式,即,意謂著包含但不限於。僅過渡片語「由...組成」及「基本上由...組成」應分別為封閉式或半封閉式過渡片語,如在美國專利局手冊之專利審查程序第2111.03節中所陳述。 In the scope of patent application and the above description, all transition phrases (such as "include", "include", "carry", "have", "contain", "involve", "retain", "consisting of" Etc.) should be understood as open-ended, that is, it means including but not limited to. Only the transitional phrases "consisting of" and "essentially consisting of" should be closed or semi-closed transitional phrases respectively, as stated in Section 2111.03 of the Patent Examination Procedure of the US Patent Office Manual .
200‧‧‧體外環路 200‧‧‧Extracorporeal Loop
206‧‧‧泵系統 206‧‧‧Pump system
208‧‧‧熱交換器 208‧‧‧Heat exchanger
210‧‧‧注入器構件 210‧‧‧Injector component
212‧‧‧脈管注入點 212‧‧‧Vessel injection point
214‧‧‧血液 214‧‧‧Blood
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