TWI702062B - Systems and methods for quantifying conductance in the vasculature - Google Patents

Abstract

The present disclosure describes quantification of the flow conductance in a region of the vasculature using a catheter member coupled to at least two pressure sensors. Data from measurements of the pressure at known, controlled patterns of flow rates at the catheter member can be used to compute values of the flow conductance for the regions of the vasculature.

Description

System and method for quantitative conduction in the vessel

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.

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.

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.

In one example, the region of the vessel may be at the proximal end of the heart.

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.

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 .

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.

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.

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: Catheter system

101: Shaft

102: plane

103: occlusion component

200: extracorporeal loop

203: Occlusion component

205: Dead Zone

206: Pump System

208: Heat Exchanger

210: Injector component

212: Vessel Injection Point

214: Blood

216: Inject fluid

320: Lumen

321: Module/Soft Airbag

324: Positive new flush flow

326: Backflush flow

328: Blood Flow

421: Components

424: Backflush flow

426: Forward flushing flow

428: Blood Flow

430: Hole/Orifice

431: Hole/Aperture

440: Spring Driven Film

442: Fluid Flow

450: Multi-leaf soft airbag

455: Futaba Soft Airbag

460: gap

465: Clover soft airbag

470: gap

510: Bias valve

521: Module/Soft Airbag

532: offset valve

534: flow

538: Blood Flow

540: offset valve

542: Bypass Lumen

548: Blood Flow

610: The first pressure sensor

612: second pressure sensor

614: injector component/insertion component/inner shaft

615: Blood Flow

616: Flow Rate Source

617: Blood Flow

618: Outer shaft

620: Conduit member/duct

622: Near End Port

700: Extracorporeal System

700': Extracorporeal system

700"‧‧‧Extracorporeal System

710‧‧‧Aorta-arterial (VA) extracorporeal circuit

711‧‧‧First port

712‧‧‧Pump

713‧‧‧ Oxygenator

714‧‧‧Main circuit oxygenator/heat exchanger

715‧‧‧Second Port

716‧‧‧Displacement or volume drive pump

718‧‧‧Regional injector branch

720‧‧‧Heat exchanger

721‧‧‧The third port

722‧‧‧Remote injector component

724‧‧‧area

726‧‧‧plus the smallest conductive component

728‧‧‧Coupling pressure sensor pair

800‧‧‧Extracorporeal Loop System

802‧‧‧Console

810‧‧‧Aorta-arterial (VA) extracorporeal circuit

811‧‧‧First port

812‧‧‧Pump

813‧‧‧Oxygenator

814‧‧‧Heat exchanger

815‧‧‧Second Port

816‧‧‧Displacement or volume drive pump

818‧‧‧ branch

820‧‧‧Heat exchanger

821‧‧‧The third port

822‧‧‧Remote injector component

826‧‧‧plus the smallest conductive components

828‧‧‧Pressure sensor pair

850‧‧‧System

852‧‧‧Control Panel

860‧‧‧Flow rate control source

862‧‧‧Liquid reservoir

872‧‧‧Remote injector component

876‧‧‧plus the smallest conductive components

878‧‧‧Pressure sensor pair

905‧‧‧Console

907‧‧‧Processing unit

909‧‧‧Memory

911‧‧‧Display unit

1002‧‧‧step

1004‧‧‧Step

1006‧‧‧Step

1052‧‧‧Step

1054‧‧‧Step

1056‧‧‧Step

1058‧‧‧Step

1060‧‧‧step

1110‧‧‧Computer device

1112'‧‧‧Processor

1114‧‧‧Core

1114'‧‧‧Core

1118‧‧‧Multi-touch interface

1120‧‧‧Pointing device

1124‧‧‧Virtual Machine

1126‧‧‧Operating System

1132‧‧‧Network Device

1134‧‧‧Storage device

1140‧‧‧Software applications

F _b ‧‧‧Flow rate/fluid/flow/blood flow

F _tip ‧‧‧Flow rate/fluid/flow/blood flow

G ₀ ‧‧‧ Fluid conduction

G _b ‧‧‧ proximal conduction

G _tip ‧‧‧Remote conduction

l ‧‧‧Discrete length

Pa‧‧‧Pressure

Pb‧‧‧Pressure

P _in ‧‧‧Pressure

P _out ‧‧‧Pressure

P _tip ‧‧‧Pressure

△‧‧‧Predefined spacing

△t‧‧‧Time period

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).

Figure 1A shows a schematic diagram of an exemplary catheter system according to one of the principles of the present invention.

Figures 1B to 1C show exemplary diagrams of fluid conduction in the vascular space across the boundary.

Figure 2A shows an exemplary extracorporeal loop according to one of the principles of the present invention.

2B to 2C show schematic diagrams of another catheter system according to the principles of the present invention.

3A to 3B show an example of another catheter system according to the principles of the present invention.

4A to 4B show an example of another catheter system according to the principles of the present invention.

Figure 4C shows an example of another catheter system according to the principles of the present invention.

4D(i) and 4D(ii) show an example of another catheter system according to the principles of the present invention.

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.

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.

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.

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.

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.

Figure 6C shows an exemplary catheter coupled to a pressure sensor in accordance with the principles of the present invention.

Figure 6D shows another exemplary catheter coupled to a pressure sensor in accordance with the principles of the present invention.

Figure 7A shows an exemplary extracorporeal loop system according to one of the principles of the present invention.

Figure 7B shows another exemplary extracorporeal loop system in accordance with the principles of the present invention.

Figure 7C shows another exemplary extracorporeal loop system in accordance with the principles of the present invention.

Figure 8A shows an exemplary extracorporeal loop system coupled to a console in accordance with the principles of the present invention.

Figure 8B shows another exemplary extracorporeal loop system coupled to a console in accordance with the principles of the present invention.

FIG. 9 is a block diagram showing an exemplary computing device according to the principles of the present invention.

10A to 10B show a flowchart illustrating an exemplary method according to the principles of the present invention.

FIG. 11 is a block diagram of an exemplary computing device according to one of the principles of the present invention.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Reducing the occurrence of flow blockage reduces or eliminates the possibility of forming dead or no-flow areas in the vessel portion.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Figure 1A shows a schematic diagram of an exemplary catheter system 100 including a shaft 101 disposed in a portion of a vessel. FIG. 1A also shows a plane 102 passing through an obstruction component 103 mounted on the shaft 101. The shaft 101 may include a lumen. In an exemplary catheter system 100, the occlusion assembly 103 may include a balloon that is inflated with saline or other solutions. Another exemplary occlusion component 103 may include being expanded to squeeze a membrane of the arterial wall using a force applied by a spring or other mechanical actuation. In one example, the occlusion component 103 may be structurally designed to extend from the shaft 101 of the catheter system 100 to contact and seal the wall of the artery or vein to significantly reduce or prevent flow. As shown in Figure 1A, the exemplary plane 102 is perpendicular to the artery segment. According to the principles herein, the exemplary occlusion assembly 103 is used to modify the fluid flow across the plane 102. The fluid flow is related to the flow outside the base holding the shaft. The degree of flow is driven by a pressure difference between the area (Pb) in front of the blocking element 103 and the area (Pa) behind the blocking element 103.

1B and 1C show exemplary graphs of fluid conduction (G ₀ ) versus time in the vascular space across the plane 102 of the occlusion component 103. FIG. 1B shows fluid conduction (G ₀ ) versus time for a complete occlusion using the occlusion assembly 103. In the example in FIG. 1B, the occluding component is activated to complete occlusion of the vasculature space of time period △ t period, reduced fluid conducting. The graph of Figure 1B shows that fluid conduction becomes zero when the occlusion assembly 103 is activated for complete occlusion. This definition is independent of pressure gradient/difference (F=G(Pa-Pb)). Figure 1C depicts a graph of the conducting fluid (G ₀₎ conditions of time during occlusion by a control section, wherein the start of one of the principles described herein occlusion assembly according to a time period during △ t. As shown in Figure 1C, conduction does not change to zero but becomes a minimum conduction level with a magnitude greater than zero.

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 .

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.

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.

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.

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.

Figure 2A shows a schematic diagram of an exemplary extracorporeal loop 200 coupled to a person. The exemplary extracorporeal loop 200 includes a pump system 206, a heat exchanger 208, and an injector component 210. An exemplary extracorporeal circuit may include two connections to a patient's vessel. This exemplary extracorporeal loop can be implemented to use one connection to pump blood from a vessel and another connection to return blood to the vessel. An exemplary extracorporeal circuit can be used in situations where the heart is not functioning or does not supply sufficient blood flow, or can be used to modify blood and return it to the systemic blood flow or a local area. Other modifications may include oxidation, dialysis, heating, removal of bacterial contaminants, removal of cancer-causing cells, etc. Figure 2A shows an injector member 210 coupled to a person's body at a vascular injection point 212 to adjust a flow rate based on using the pump system 206 to return blood 214 to the body. The most distal location in the vessel where blood is injected into the body is referred to herein as the "vascular injection point."

In one example, the injector member 210 may include a function for making blood flow on one side with the other On one side, an extracorporeal loop is injected into an occlusion component of fluid separated through the device shaft. This can create an area of no flow or restricted flow in a part of the vessel, that is, a dead area. If an occlusion system is located at an exact position relative to the nearest vessel branch, the dead zone can be avoided, but in practice, this exact placement cannot be guaranteed in real patients. Therefore, a dead zone is often formed in the branch containing the injection point where blood does not flow. If the occlusion remains in place for a long period of time, this can potentially lead to the formation of thrombus or blood clots. The extracorporeal blood supply circuit can be used for long periods (such as but not limited to hours on the order of days), which can be sufficient to increase the risk of thrombosis or clot formation.

2B shows an exemplary injector member 210, which is a component of the exemplary extracorporeal loop system of FIG. 2A and returns blood to a specific location in the body vascular injection point 212. The injected fluid 216 through the lumen of the shaft can be added to the blood flow in this branch. When the replacement blood flow is blocked, the injected blood can dominate the flow in the distal vessel.

2C shows an exemplary injector member 210, which is a component of the exemplary extracorporeal loop system of FIG. 2A and returns blood (injection fluid 216) to a specific location in the body. The injector member 210 is coupled to an occlusion assembly 203 that is shown to completely occlude a portion of the vessel. As shown in FIG. 2C, when the injector member 210 injects blood at a vessel injection point through the occlusion device 203, a dead area 205 may be formed at the proximal end of the occlusion component 203.

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 lumen 320 having a discrete length l , arranged along the shaft of the device and under a component 321 (such as but not limited to a soft balloon 321) so that it is opposite The flow used to flush the dead area provides a minimum conduction. This lumen 320 controlled by the design length and diameter can make the fluid exhibit a constant flow rate and therefore allow a small bypass flow. FIG. 3A shows the positive new flushing flow 324 through the lumen 320. Figure 3B shows the backwash flow 326 (backwash flow) through the lumen 320. The dotted lines in FIGS. 3A to 3B are used to show the direction of blood flow 328. In both Figures 3A and 3B, the minimally conductive fluid can be used to flush the dead area at the proximal end of the assembly 321, thereby preventing or minimizing unnecessary thrombosis.

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 orifices 430, but not The additional lumen below the minimal conductive component (as shown in Figure 3A to Figure 3B). In these exemplary systems, a portion of the stream 424 directed toward the distal tip of the device leaks through one or more holes (or orifices) 430 before occlusion is achieved. Figure 4A also shows the direction of blood flow 428. FIG. 4A shows an example when the value of the pressure Pb is less than the pressure Pa, which results in a backwash flow (shown as flow 424). FIG. 4B shows an exemplary case where Pb relative to Pa is large enough to form a forward flushing flow 426 plus a minimum conduction system.

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 film 440 is shown. However, the membrane 440 includes one or more substantially solid membrane portions symmetrically deployed (similar to the deployment of an umbrella) around the device axis. FIG. 4C also shows the direction of the part of the blood flow 428 and the fluid flow 442 that leak through one or more holes (or apertures) 431 of the additional smallest conductive component.

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 gap 470.

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.

Figure 5A(i) shows an exemplary additional minimal conduction system that includes a bias valve 510 on an aperture in a catheter lumen that includes a component 521 (such as but not limited to a soft balloon). The parameters P _in and P _out are the pressure in the lumen and the pressure outside the proximal end of the soft balloon 521. In this example, the distal zone is the zone where the flow rate and pressure are dominated by the flow injected through the lumen and through the distal tip. Generally speaking, if P _out is driven by the heart, the value of P _out has a cycle similar to the heartbeat, so that a local maximum and minimum are reached in each cycle. Figure 5A(ii) shows an exemplary bias valve that can be implemented in the exemplary system of Figure 5A(i). Figure 5A(ii) shows an exemplary bias valve 510 mounted to a portion of a shaft of a catheter, which has a hole that couples the inner lumen of the shaft to the outside and is larger than the hole and anchored on at least one side One of the flexible plastic flaps covering the hole. The exemplary bias valve is structurally designed such that a positive pressure difference (the pressure inside the shaft is greater than the pressure outside the shaft) can cause the flexible plastic flap to open, allowing fluid to flow outward, and a negative pressure difference ( The pressure inside the shaft is lower than the pressure outside the shaft) can cause the flexible plastic flap to close and seal the edge of the hole, thereby blocking fluid flow inward.

FIG. 5B shows an exemplary additional minimal conduction system including a bias valve 532 coupled to a component 521. The bias valve 532 includes a flap that is structurally designed to open and allow fluid to flow out of the central lumen of the injection member but not to flow into the lumen. That is, when the value of the pressure P _b is lower than the pressure P _a, 534 biasing the valve 532 is allowed to flow, this occurs during the heartbeat cycle at certain time intervals. FIG. 5B shows the portion of the flow 534 of the flap passing through the bias valve 532 and the direction of the blood flow 538. In this example, only a small portion of the blood injected into the body from the extracorporeal loop is used to flush the dead area (ie, the flow 534 through the bias valve).

Figure 5C shows an exemplary additional minimal conduction system that includes a flap on one end of a bypass lumen 542 that acts as a bias valve 540. Similar to the minimal conduction system shown in FIG. 3A or FIG. 3B, the lumen 542 has a discrete length l and is positioned along the axis of the injector member and below the assembly 521. The coupling action of the bias valve 540 and the bypass lumen 542 convection provides a minimum conduction to flush out dead areas (or low flow areas). FIG. 5C shows the portion of the flow 544 of the flap through the bias valve 540 and the direction of the blood flow 548. The flap of the bias valve 540 can be installed on the proximal or distal end of the bypass lumen 542, thereby allowing the direction of the irrigation flow to be selected by design. That is, if a flap is structurally designed to allow only outward fluid conduction to be installed at the proximal end of the lumen 542 (as shown in FIG. 5C), the blood injected at the distal end returns for flushing. If the flap is installed at the distal end of the lumen 542, the normal blood flow from the branch is flushed forward and mixed with the injected blood flow at the vascular injection point. The detailed operation part is determined by the applied pressure difference between P _b (pressure in front of lumen 542) and P _a (pressure behind lumen 542). This is because the bias valve can be structured to allow only one direction On the flow. If the P-value P _B and _a close enough so that the pressure with the contraction of the heart / diastolic blood pressure P _B changes due to changes result of the bias of the valve open during certain time intervals in the cardiac cycle, this exemplary embodiment is based will be advantageous.

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.

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.

Figure 6A shows an exemplary control shunt system of the present invention. The exemplary control shunt system includes a first pressure sensor 610 and a second pressure sensor 612. The first pressure sensor 610 can be placed at the proximal end of the tip of the injector member 614 of a catheter, and the second pressure sensor 612 can be spaced from the proximal end of an operator such as from the tip (or from the pressure sensing The injector 610) measures a predetermined distance (△) and is arranged on the injector member 614. As a non-limiting example, the predefined distance (Δ) may be about 2 cm, about 5 cm, about 8 cm, about 12 cm, about 15 cm, about 20 cm, about 25 cm, or about 30 cm. In various non-limiting examples, one or both of the pressure sensors 610 and 612 can be implemented as silicon-based sensors (with electronic (wired) readout) embedded in the catheter wall or used in the catheter wall The optical fiber in the lumen can provide the readout to the fiber-based pressure sensor of the appropriate computing interface system at the proximal end of the catheter. In another exemplary embodiment, one or both of the pressure sensors 610 and 612 are structurally designed for use: a simple wall lumen with a distal opening at the position as shown in FIG. 6A And it is filled with an incompressible fluid; and an external pressure sensor installed on a fluid connector at the proximal end of the catheter to measure the static or low-frequency pressure conducted by the liquid column of the lumen. The pressure sensor 610 can be structurally designed to measure the pressure at the proximal end of the tip (P _tip ) and the pressure sensor 612 can be structurally designed to measure the pressure at the proximal end of the injector member 614 (P _b ) . Figure 6A also shows in the blood by _b and at the injector tip by means of the injection flow rate F _Tip of the catheter through direction in the vicinity of the blood flow rate F.

As also shown in Figure 6A, the catheter can be coupled to a flow rate source 616 of an extracorporeal system. In an exemplary embodiment, the fluid may be volumetric flow driven rather than pressure driven. When the fluid (F _tip ) is injected into the vessel through the tip, it mixes with the fluid (F _b ) from the upstream and flows through the downstream conduction G _tip . Display upstream flow through the conductivity G _b, where there is a space between the arterial (or venous) wall of the catheter in FIG. 6A. It may be difficult to directly measure or predict one value of conduction G _b . Even in the case where the pressure sensors 610 and 612 are arranged to measure P _tip and P _b , if G _b is unknown, it may still be difficult to directly measure F _b . An exemplary system and method based on the principles in this article can be used to determine a value of G _b .

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.

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.

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).

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.

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.

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 pressure sensors 610 and 612. The second conduction (referred to as distal conduction (G _tip )) is the conduction of blood from the tip to the core system (or ground in a flowing sense). In the case of no measurement, these two conductions are usually not inferred, because the calculation will use data indicating the size and shape of the regional vessel. In the case of G _tip , the calculation will use data indicating the state of the vascular bed and/or the degree of damage. Knowledge of the values of these two conductions can provide clinical benefits because they are one of the measurements that represent the local state of the patient's vasodilation/vasoconstriction. Use pressure sensors 610 and 612 to measure P _tip and P _b , if the conduction between them is the control conduction with one of the smallest conduction in addition to the previously described, then the flow F _b =G _b (P _b -P _tip ) Estimate the flow. In an exemplary embodiment in which the calculation of G _b includes data indicating the surface of a vein or artery, G _b cannot be determined in advance. Generally speaking, it is impossible to determine G _tip before an operation involving the placement of the injection member or other medical procedures.

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)... (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.

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.

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.

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 .

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.

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 pressure sensors 610 and 612 are coupled to an insertion member 614 that is a part of an extracorporeal loop access catheter that is a concentric shaft member type. In this example, the outer shaft 618 supplies blood to the extracorporeal circuit 200 and the inner shaft 614 serves as an insertion member for returning blood to a location in the body. Figure 6B also shows the dashed line 615 of blood flowing out to the extracorporeal loop and the dashed line 617 of blood flow (Fb) around a catheter. As non-limiting examples, US 7,704,220 and US Patent No. 7,789,846 disclose examples of concentric extracorporeal access catheters that can be implemented in one or more exemplary systems according to the principles herein.

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 pressure sensors 610 and 612 coupled to a conduit member 620. In this example, pressure sensor measurements can be used to calculate conduction as described herein. In one example, using pressure measurement, conduction can be calculated according to the exemplary method described above for calculating both in vivo G _b and G _tip . In the example of FIG. 6C, fluid flow may be introduced from the distal tip of one of the catheter members 620. FIG. 6D shows another exemplary system, which is similar to FIG. 6C, but the catheter 620 includes a proximal port 622 that allows fluid flow from a more central region of the catheter member 620.

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.

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.

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.

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.

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.

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.

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 extracorporeal system 700 is a three-port, two-zone extracorporeal circuit, in which an aortic-arterial (VA) extracorporeal circuit 710 extracts blood from the body through a first port 711 and uses a The pump 712 and the oxygenator/heat exchanger 714 return blood through a second port 715. The exemplary system may include a displacement or volume-driven pump 716, which is positioned on a branch 718 of the main circuit and pulls a controlled volume flow rate of blood out of the main circuit and passes through a The independent heat exchanger 720, a third port 721, and the distal injector member 722 inject blood into an area 724 of the body. In a non-limiting example, branch 718 may be a local perfusion hypothermic branch. The non-limiting exemplary system of Figure 7A allows two independently controlled temperature zones to be established in the body when appropriate zone temperature sensors are deployed. In other examples, the branch 718 may be coupled to the main circuit before or after the main circuit oxygenator 714 depending on whether the user needs to oxygenate the blood of the injector component. In these examples, if the system is used to apply local low temperatures such as those disclosed in International (PCT) Application No. PCT/US2015/033529 through the distal injector member, one of the concentric cylinders on the injector member will flow out This lack can lead to an increase in conductive cooling from the component catheter to the artery (the component catheter is placed in the artery). This effect may require some additional warming on the main loop loop to achieve equivalent thermal targets in the body area that needs to be controlled.

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 extracorporeal circuit 710, the main VA extracorporeal circuit 710 from the body through a first port 711 The blood is extracted and returned through a second port 715 using a pump 712, an oxygenator 713, and a heat exchanger 714. In a non-limiting example, the oxygenator 713 and the heat exchanger 714 may be a combined unit. The exemplary system 700' also includes a displacement or volume-driven pump 716 positioned on a branch 718 to pull a controlled volume flow rate of blood out of the main loop and pass through an independent The heat exchanger 720, a third port 721, and a distal injector member 722 inject blood into a local area of the body. In the example of the extracorporeal system 700', the injector member may also include: an occlusion member; an additional minimal conductive component (according to any of the examples herein, including any of FIGS. 3A to 5C); or A pair of pressure sensors coupled to the injector member (according to any of the examples herein, including FIG. 6A or FIG. 6B); or a pair of pressure sensors and an occluding member or an additional minimal conductive component Both. In the non-limiting exemplary system of FIG. 7B, the injector member 722 includes both an additional minimal conductive component 726 and a pair of coupled pressure sensors 728. In the example of FIG. 7B, the oxygenator 714 on the main circuit is positioned in front of the regional injector branch 718 and therefore the locally injected blood stream is oxygenated.

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 extracorporeal system 700" of FIG. 7C, the oxygenator 713 on the main circuit is positioned to follow the circuit behind the local injector branch, and therefore the locally injected blood flow is not directly oxygenated. In a non-limiting example , The oxygenator 713 and the heat exchanger 714 can be a combined unit.

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.

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.

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).

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.

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.

Figure 8A shows an exemplary extracorporeal loop system 800 coupled to a console 802 according to the principles herein. Similar to FIG. 7B, the extracorporeal system 800 of FIG. 8A includes a main VA extracorporeal circuit 810 that extracts blood from the body via a first port 811 and uses a pump 812, an oxygenator 813 and a heat exchange The device 814 returns blood through a second port 815. In a non-limiting example, the oxygenator 813 and the heat exchanger 814 may be a combined unit. The exemplary system 800 also includes a displacement or volume-driven pump 816, which is positioned on a branch 818 to pull a controlled volume flow rate of blood out of the main loop and through an independent heat exchange The device 820, a third port 821 and a distal injector member 822 inject blood into a local area of the body. Also similar to the non-limiting exemplary system of FIG. 7B, the injector component includes an additional minimal conductive component 826 and a pressure sensor pair 828. In the example of FIG. 8A, the console 802 is coupled to a displacement or volume-driven pump 816 and a pair of pressure sensors 828 positioned on a branch 818. In other examples, the console 802 may be coupled to different components of the system, including any one or more of the pump, heat exchanger, and/or oxygenator of the exemplary system.

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.

In an example, the console 802 can be configured as an operation console. In this example, the operating console may include a graphical user interface for driving a water cooler/heater of the heat exchanger and a graphical user interface designed to display user commands for implementing an operating sequence . The graphical user interface of the console 802 can be structurally designed to implement the operation sequence to cause the extracorporeal loop to control the temperature of the blood perfused from the second port to adjust a temperature measurement reported by at least one temperature sensor to maintain A core body target range, and causes the extracorporeal loop to control the temperature of blood injected into the local area, so that at least one temperature sensor reports a temperature measurement within a target area temperature range.

The exemplary console 802 can be structured to automate the performance of Gb and Gtip measurements using the method of controlling the shunt system described herein. Based on the received input, the console can cause a processor to execute instructions for recording data indicating the flow in the injector member and the value of the pressure on the injector member, while also controlling the amount of flow rate injected, The principle of any one of the examples described herein is used to assist or realize the automatic performance of the method of measuring the proximal conduction and the distal conduction at the injector member. This exemplary console 802 can be structurally designed to automate the control shunt system, where the control shunt system is applied to be coupled to an overall external circuit or has an external volume flow rate source (such as but not limited to the example in FIG. 6A) The injector component of another catheter system.

Figure 8B shows another exemplary system 850 coupled to a console 852 in accordance with the principles herein. The exemplary system 850 includes a flow rate control source 860 and a reservoir 862. As a non-limiting example, the exemplary flow rate control source 860 and reservoir 862 may be, but are not limited to, a syringe or syringe driver. The exemplary system 850 also includes a distal injector member 872 coupled to a local area of a body. The injector member 872 includes an additional minimum conductive component 876 and a pressure sensor pair 878. In the example of FIG. 8B, the console 802 is coupled to the flow rate control source 860 and the pressure sensor pair 878. In the example of FIG. 8B, the flow rate control source 860 and The reservoir 862 is used to establish two Ftip settings to control the split system (according to any of the examples described above). As a non-limiting example, based on the settings of the command received at the console, blood can be drawn to the reservoir for 2 minutes at, for example, 50ml/min first, then wait for two minutes, and then return blood at 50ml/min. Two minutes. In this non-limiting example, this establishes Ftip=-50ml/min, Ftip=0, and Ftip=+50ml/min. Based on input received at the console 852, for example from a user or other computing device, instructions can be executed to execute any other desired procedures according to the settings specified in the input.

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.

According to one of the principles in this article, an exemplary system may include a console. FIG. 9 shows an exemplary console 905 that includes at least one processing unit 907 and a memory 909. An exemplary control panel may include, for example, a desktop computer, a laptop computer, a tablet computer, a smart phone, a server, a computing cloud, a combination thereof, or the ability to be combined with one based on the principles in this document. Any other suitable device for electronic communication of a controller or other system. The exemplary processing unit 907 may include, but is not limited to, a microchip, a processor, a microprocessor, a dedicated processor, a specific application integrated circuit, a microcontroller, a programmable gate array, any other suitable Processor, or a combination thereof. Exemplary memory 909 may include, but is not limited to, hardware memory, non-transitory tangible media, storage disks, optical disks, flash drives, computing device memory, random access memory (such as but not limited to DRAM, SRAM , EDO RAM), any other type of memory, or a combination thereof.

In an example, the console may include a display unit 911. The exemplary display unit 111 may include, but is not limited to, an LED monitor, an LCD monitor, a television, a CRT monitor, a touch screen, a computer monitor, a touch screen monitor, and a mobile device ( Such as but not limited to a smart phone, a tablet computer or an e-book) a screen or display, and/or any other display unit.

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.

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.

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 step 1052, a first time interval (T _A) the inner member (or a catheter member) will be injected of a first control to a constant flow rate. In step 1054, recording at least a first pressure measurement using the first pressure sensor and each of those of the second pressure sensor (P _1A and P _1B) during the first time interval (T _A). In step 1056, a second time interval (T _B) will be injected into the bloodstream of the distal tip of the injector control member to a second one of said constant flow rate is different from the first constant flow rate. In step 1058, recording at least a second pressure measurement using the first pressure sensor and each of those of the second pressure sensor (P _2A and P _2B) during the second time interval (T _B). In step 1060, at least one processor of the processing unit is used to calculate the injector using data indicating the first pressure measurement, the second pressure measurement, the first constant flow rate, and the second constant flow rate At least one of a proximal external conduction or a distal external conduction at the distal tip of the member (or catheter member).

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.

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.

FIG. 11 is a block diagram of an exemplary computing device 1110 that can be used to perform an operation according to the principles herein. In any example herein, the computing device 1110 can be structured as a console. For the sake of clarity, FIG. 11 is also mentioned again and provides more detailed details about the various elements of the exemplary system of FIG. 9. The computing device 1110 may include one or more non-transitory computer-readable media for storing one or more computer-executable instructions or software to implement the examples. The non-transitory computer-readable medium may include, but is not limited to, one or more of the following types of hardware memory, non-transitory tangible media (for example, one or more storage disks, one or more optical disks, one or more flash drives Flash drive device) etc. For example, the memory 909 included in the computing device 1110 can store computer-readable and computer-executable instructions or software for performing the operations disclosed herein. For example, the memory 909 may store a software application 1140 that is structured to perform various disclosed operations (eg, cause a controller control flow, record a pressure sensor measurement, or perform a calculation). The computing device 1110 may also include a structurally designed and/or programmable processor 907 and an associated core 1114, and is used to execute computer-readable and computer-executable instructions or software stored in the memory 909 as necessary, and One or more additional structurally designed and/or programmable processing devices in other programs of the control system hardware, for example, the processor 1112' and the associated core 1114' (for example, when there are multiple processors/cores In the case of computing devices). The processor 907 and the processor 1112' may each be a single-core processor or a multi-core (1114 and 1114') processor.

Virtualization can be used in the computing device 1110 to dynamically share the infrastructure and resources in the console. A virtual machine 1124 can be provided to handle one of multiple processors running The program makes the program appear to use only one computing resource instead of multiple computing resources. Multiple virtual machines can also be used in conjunction with one processor.

The memory 909 may include a computing device memory or random access memory, such as DRAM, SRAM, EDO RAM, etc. The memory 909 may also include other types of memory or a combination thereof.

A user can interact with the computing device 1110 through a visual display unit 1128 (such as a computer monitor that can display one or more user interfaces 1130 according to the exemplary system and method). The computing device 1110 may include other I/O devices for receiving input from a user, such as a keyboard or any suitable multi-touch interface 1118, and a pointing device 1120 (eg, a mouse). The keyboard 1118 and the pointing device 1120 may be coupled to the visual display unit 1128. The computing device 1110 may include other suitable conventional I/O peripheral devices.

The computing device 1110 may also include one or more storage devices 1134, such as a hard disk drive, CD-ROM, or other computer readable data for storing and performing the operations disclosed herein, and computer readable instructions and/or software media. The exemplary storage device 1134 may also store one or more databases for storing any suitable information required by the exemplary system and method. The database can be manually or automatically updated at any suitable time to add, delete and/or update one or more items in the database.

The computing device 1110 may include a network interface 1122, which is structured to pass through one or more network devices 1132 through various connections (including but not limited to standard telephone lines, local area networks (LAN) or wide area network (WAN) chains Connection (for example, 802.11, T1, T3, 56kb, X.25), broadband connection (for example, ISDN, frame repeater, ATM), wireless connection, controller area network (CAN) or any of the above connections One or some combination of all) to interface with one or more networks (for example, LAN, WAN, or Internet). The network interface 1122 may include a built-in network adapter, a network interface card, a PCMCIA network card, a card bus network adapter, a wireless network adapter, a USB network adapter, a modem, or a modem suitable for connecting a computing device 1110 Connect to any type of network capable of communicating and performing the operations described in this article Any other devices. In addition, the computing device 1110 can be any computing device, such as a workstation, a desktop computer, a server, a laptop computer, a handheld computer, a tablet computer, or a computer capable of communicating and capable of performing the operations described herein. Other forms of computing or telecommunication devices with sufficient processor power and memory capacity.

The computing device 1110 can run any operating system 1126, such as any version of Microsoft® Windows® operating system, different versions of Unix and Linux operating systems, any version of MacOS® for Macintosh computers, any embedded operating system, and any real-time operation System, any open source operating system, any proprietary operating system, or any other operating system that can run on the console and perform the operations described in this article. In some examples, the operating system 1126 can run in a native mode or an analog mode. In one example, the operating system 1126 may run on one or more cloud machine instances.

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.

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.

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.

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.

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.

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.

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.

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.

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.

in conclusion

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.

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.

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.

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.

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.

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).

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.

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".

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).

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.

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.

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‧‧‧Extracorporeal Loop

206‧‧‧Pump system

208‧‧‧Heat exchanger

210‧‧‧Injector component

212‧‧‧Vessel injection point

214‧‧‧Blood

Claims (37)

A method for quantitative conduction in a vessel, comprising: coupling a catheter member to a part of a body, the catheter member including a distal tip and a shaft with a lumen; wherein a first pressure sensor is arranged At the proximal end of the distal tip; and one of the second pressure sensors is placed on an outer surface of the shaft, which is placed at the proximal end of the distal tip; within a time interval T , the The fluid flow injected at the distal tip is controlled to a predetermined flow rate mode; within the time interval T , the pressure measurement using the first pressure sensor and the second pressure sensor is recorded; and the instructions for use The pressure measurement and the data of the predetermined flow rate pattern calculate at least one of a proximal external conduction or a distal external conduction at the distal tip. Such as the method of claim 1, wherein the predetermined flow rate pattern includes a first constant flow rate within a first time interval t ₁ < T and a second time interval t following the first time interval t _{1 2} < T is a second constant flow rate different from the first constant flow rate. The method of claim 2, wherein the controlling the fluid flow comprises: using an injection flow rate source to control the fluid flow injected at the distal tip to the first constant flow rate within the first time interval t ₁ ; and t _2, using the injection flow rate of the source will be injected into the fluid stream at the distal tip of the second control to a constant flow rate at the second time interval. Such as the method of claim 3, wherein the recording the pressure measurements includes: during the first time interval t ₁ , recording the first pressure measurement using the first pressure sensor and the second pressure sensor ; And in the second time interval t ₂ , record the second pressure measurement using the first pressure sensor and the second pressure sensor. Such as the method of claim 4, wherein data indicating the first pressure measurements, the second pressure measurements, the first constant flow rate, and the second constant flow rate are used to calculate the proximal end of the distal tip The at least one of terminal external conduction or the distal external conduction. The method of claim 1, further comprising controlling the flow so that the fluid injected at the distal tip flows according to a step function. The method of claim 1, wherein the second pressure sensor is separated from the first pressure sensor by a distance greater than or approximately equal to twice a diameter of a vessel from the proximal end of the distal tip . The method of claim 1, wherein the second pressure sensor is arranged at a distance greater than about 1.0 cm from the proximal end of the distal tip. The method of claim 1, further comprising adding a first amount of at least one of a drug or medicament to the fluid injected at the distal tip. The method of claim 9, further comprising calculating the amount of the drug or medicament in one of the fluids mixed with the distal flow based on the first amount and the value of at least one of the proximal external conduction or the distal external conduction At least one of the first concentration. The method of claim 10, further comprising adding a second amount of the at least one of a drug or a drug to the fluid at the distal tip based on the value of the first concentration to derive the fluid at the mixed distal end A second concentration in the stream different from the first concentration. A system for quantitative conduction in a vessel, which includes: a catheter member, which includes a distal tip and a shaft with a lumen; and a control shunt system, which includes: a first pressure sensor, which Arranged at the proximal end of the distal tip; a second pressure sensor arranged on an outer surface of the shaft and 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. Such as the system of claim 12, wherein the injection flow rate source is a syringe pump or a rotary pump. For example, the system of claim 12, which further includes a first-class control module, the flow control module being programmed to: respond to the injection flow according to the predetermined flow rate mode, based on the instruction of the first pressure sensor and the second The measurement data of the pressure sensor calculates an indication of a near-end external conduction. Such as the system of claim 14, wherein the flow control module is further programmed to generate a signal indicating a first-rate parameter to adjust the blood flow or maintain the blood flow in the vessel at a predetermined flow rate value. The system of claim 12, wherein the second pressure sensor is disposed on the outer surface of the shaft at a distance greater than or approximately equal to twice a diameter of the vessel in the region of the distal tip , Placed at the proximal end of the distal tip. The system of claim 12, wherein the control shunt system is used to adjust the concentration of at least one of a certain amount of a drug or medicament added to an injection fluid, so that the concentration of the drug or medicament in the mixed distal fluid Reach a required level. A system for quantitative conduction in a vessel, which includes: a catheter member, which includes a distal tip and a shaft with a lumen; a control shunt system, which includes: a first pressure sensor, which is arranged At the proximal end of the distal tip; a second pressure sensor arranged on an outer surface of the shaft member at the proximal end of the distal tip; and an injection flow rate source coupled to the The catheter member to cause an injection flow in the lumen according to a predetermined flow rate pattern; and A control panel, comprising: a display unit; and at least one processing unit, which is programmed to: calculate a conduction based on the pressure measurement performed using the first pressure sensor and the second pressure sensor A value; and generating a signal to cause the display unit to display an indication of the conduction value. Such as the system of claim 18, wherein the at least one processing unit is programmed to: within a time interval T , receive instructions for the pressure when the blood flow is injected at the distal tip according to the predetermined flow rate pattern Measured data; and using the data indicating the pressure measurements and the predetermined flow rate mode, the conduction is calculated as at least one of a proximal external conduction or a distal external conduction at the distal tip. Such as the system of claim 19, wherein the predetermined flow rate mode includes a first constant flow rate within a first time interval t ₁ < T and a second time interval t ₂ <after the first time interval A second constant flow rate different from the first constant flow rate in T. Such as the system of claim 20, wherein the at least one processing unit is further programmed to cause the injection flow rate source: in the first time interval t ₁ , the fluid flow injected at the distal tip is controlled to the A first constant flow rate; and within the second time interval t ₂ , the fluid flow injected at the distal tip is controlled to the second constant flow rate. Such as the system of claim 21, wherein the at least one processing unit is further programmed to: record the first pressure using the first pressure sensor and the second pressure sensor in the first time interval t ₁ Measure; and in the second time interval t ₂ , record a second pressure measurement using the first pressure sensor and the second pressure sensor. Such as the system of claim 20, wherein the at least one processing unit is further programmed to calculate the near-end external conduction or the remote-external conduction in a third time interval later than one of the first time interval and the second time interval Projection of at least one of conduction. Such as the system of claim 19, wherein data indicating the first pressure measurements, the second pressure measurements, the first constant flow rate, and the second constant flow rate are used to calculate the proximal end of the distal tip The at least one of terminal external conduction or the distal external conduction. For example, the system of claim 19, wherein the console further includes a display unit for displaying at least one indication of the proximal external conduction or the distal external conduction. The system of claim 18, wherein the injection flow rate source is a volume flow controller, which is structured to control the flow so that the fluid injected at the distal tip flows according to a step function. The system of claim 18, wherein the at least the second pressure sensor is disposed at a distance greater than about 1.0 cm from the proximal end of the distal tip. The system of claim 18, wherein the at least one processing unit is further programmed to calculate based on a quantity of at least one of a drug or a drug added to a fluid at the distal tip and a value of the conduction A concentration of the at least one of a drug or medicament in a mixed distal stream. A method for quantitative conduction in a vessel, comprising: coupling a catheter member and a control shunt system to a part of a body, the catheter member includes a distal tip and a shaft with a lumen, and the control shunt The system includes: a first pressure sensor arranged on the proximal end of the distal tip of the catheter member; a second pressure sensor arranged on an outer surface of the catheter member shaft and arranged on 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; within a first time interval T ₁ , use The injection flow rate source controls the fluid flow injected at the distal tip to a predetermined flow rate mode; in the first time interval T ₁ , the first pressure sensor and the second pressure sensor are recorded using Pressure measurement of the sensor; use the data indicating the pressure measurements and the predetermined flow rate mode to calculate a value of a proximal external conduction at the distal tip; use the first and second pressure measurements and The calculated proximal external conduction calculates the external flow rate, and uses the external flow rate to calculate the ratio of the injected flow rate to the external flow rate in the distal mixed fluid; and control the drug or drug added to the injected fluid The amount of the drug, and the calculated ratio of the injected flow rate to the external flow rate is used to adjust the amount so as to derive a specified concentration of one of the drug or the drug in the mixed distal fluid. Such as the method of claim 29, wherein the predetermined flow rate pattern includes a first constant flow rate within a first time interval t ₁ < T and a second time interval t ₂ <after the first time interval A second constant flow rate different from the first constant flow rate in T. The method of claim 30, wherein the controlling the fluid flow comprises: using the injection flow rate source to control the fluid flow injected at the distal tip to the first constant flow within the first time interval t ₁ And within the second time interval t ₂ , using the injection flow rate source to control the fluid flow injected at the distal tip to the second constant flow rate. Such as the method of claim 31, wherein the recording the pressure measurements includes: recording the first pressure measurement using the first pressure sensor and the second pressure sensor in the first time interval t ₁ ; And in the second time interval t ₂ , record the second pressure measurement using the first pressure sensor and the second pressure sensor. Such as the method of claim 32, wherein data indicating the first pressure measurements, the second pressure measurements, the first constant flow rate, and the second constant flow rate are used to calculate the proximal end of the distal tip The at least one of terminal external conduction or the distal external conduction. The method of claim 29, wherein the second pressure sensor is disposed on the outer shaft of the shaft at a distance greater than or approximately equal to about twice the diameter of the vessel from the proximal end of the distal tip On the surface. The method of claim 29, further comprising controlling the fluid flow injected at the distal tip to maintain the flow rate at a value, so that blood flow is used to flush the vessel at the proximal end of the additional minimal conduction component a district. The method of claim 29, further comprising controlling the flow so that the fluid injected at the distal tip flows according to a step function. The method of claim 29, wherein the second pressure sensor is disposed at a distance greater than about 1.0 cm from the proximal end of the distal tip.

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